Vol. 82 Monday, No. 217 November 13, 2017
Pages 52173–52642
OFFICE OF THE FEDERAL REGISTER
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The FEDERAL REGISTER (ISSN 0097–6326) is published daily, SUBSCRIPTIONS AND COPIES Monday through Friday, except official holidays, by the Office PUBLIC of the Federal Register, National Archives and Records Administration, Washington, DC 20408, under the Federal Register Subscriptions: Act (44 U.S.C. Ch. 15) and the regulations of the Administrative Paper or fiche 202–512–1800 Committee of the Federal Register (1 CFR Ch. I). The Assistance with public subscriptions 202–512–1806 Superintendent of Documents, U.S. Government Publishing Office, Washington, DC 20402 is the exclusive distributor of the official General online information 202–512–1530; 1–888–293–6498 edition. Periodicals postage is paid at Washington, DC. Single copies/back copies: The FEDERAL REGISTER provides a uniform system for making Paper or fiche 202–512–1800 available to the public regulations and legal notices issued by Assistance with public single copies 1–866–512–1800 Federal agencies. These include Presidential proclamations and (Toll-Free) Executive Orders, Federal agency documents having general FEDERAL AGENCIES applicability and legal effect, documents required to be published Subscriptions: by act of Congress, and other Federal agency documents of public interest. Assistance with Federal agency subscriptions: Documents are on file for public inspection in the Office of the Email [email protected] Federal Register the day before they are published, unless the Phone 202–741–6000 issuing agency requests earlier filing. For a list of documents currently on file for public inspection, see www.ofr.gov. The seal of the National Archives and Records Administration authenticates the Federal Register as the official serial publication established under the Federal Register Act. Under 44 U.S.C. 1507, the contents of the Federal Register shall be judicially noticed. The Federal Register is published in paper and on 24x microfiche. It is also available online at no charge at www.fdsys.gov, a service of the U.S. Government Publishing Office. The online edition of the Federal Register is issued under the authority of the Administrative Committee of the Federal Register as the official legal equivalent of the paper and microfiche editions (44 U.S.C. 4101 and 1 CFR 5.10). It is updated by 6:00 a.m. each day the Federal Register is published and includes both text and graphics from Volume 59, 1 (January 2, 1994) forward. For more information, contact the GPO Customer Contact Center, U.S. Government Publishing Office. Phone 202-512-1800 or 866-512- 1800 (toll free). E-mail, gpocusthelp.com. The annual subscription price for the Federal Register paper edition is $749 plus postage, or $808, plus postage, for a combined Federal Register, Federal Register Index and List of CFR Sections Affected (LSA) subscription; the microfiche edition of the Federal Register including the Federal Register Index and LSA is $165, plus postage. Six month subscriptions are available for one-half the annual rate. The prevailing postal rates will be applied to orders according to the delivery method requested. The price of a single copy of the daily Federal Register, including postage, is based on the number of pages: $11 for an issue containing less than 200 pages; $22 for an issue containing 200 to 400 pages; and $33 for an issue containing more than 400 pages. Single issues of the microfiche edition may be purchased for $3 per copy, including postage. Remit check or money order, made payable to the Superintendent of Documents, or charge to your GPO Deposit Account, VISA, MasterCard, American Express, or Discover. Mail to: U.S. Government Publishing Office—New Orders, P.O. Box 979050, St. Louis, MO 63197-9000; or call toll free 1-866-512-1800, DC area 202-512-1800; or go to the U.S. Government Online Bookstore site, see bookstore.gpo.gov. There are no restrictions on the republication of material appearing in the Federal Register. How To Cite This Publication: Use the volume number and the page number. Example: 82 FR 12345. Postmaster: Send address changes to the Superintendent of Documents, Federal Register, U.S. Government Publishing Office, Washington, DC 20402, along with the entire mailing label from the last issue received.
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Contents Federal Register Vol. 82, No. 217
Monday, November 13, 2017
Agriculture Department Commerce Department See National Institute of Food and Agriculture See Foreign-Trade Zones Board See Procurement and Property Management Office, See International Trade Administration Agriculture Department See National Oceanic and Atmospheric Administration Antitrust Division NOTICES Community Living Administration Changes under National Cooperative Research and NOTICES Production Act: Agency Information Collection Activities; Proposals, National Spectrum Consortium, 52331 Submissions, and Approvals: PDES, Inc., 52331–52332 Semiannual Performance Measures for the ACL Pistoia Alliance, Inc., 52318 Traumatic Brain Injury State Partnership Program, ROS-Industrial Consortium-Americas, 52319 52305–52306 UHD Alliance, Inc., 52332 Vehicle Safety Communications 8 Consortium, 52331 Copyright Office, Library of Congress Proposed Final Judgments and Competitive Impact RULES Statements: Fees for Electronic Recordation and Notices of Intention to Entercom Communications Corp., et al., 52319–52331 Obtain a Compulsory License, 52221–52224 Modernizing Copyright Recordation, 52213–52221 Broadcasting Board of Governors Secure Tests, 52224–52229 NOTICES PROPOSED RULES Meetings; Sunshine Act, 52264 Group Registration of Unpublished Works, 52258–52259 Bureau of Consumer Financial Protection NOTICES Education Department Requests for Information: NOTICES Consumers’ Experience with Free Access to Credit Agency Information Collection Activities; Proposals, Scores, 52284–52286 Submissions, and Approvals: Update to the Public List of Companies that Offer Teacher Education Assistance for College and Higher Customers Free Access to a Credit Score, 52286–52287 Education Grant Eligibility Regulations, 52287–52288 Centers for Disease Control and Prevention Employment and Training Administration NOTICES NOTICES Agency Information Collection Activities; Proposals, Agency Information Collection Activities; Proposals, Submissions, and Approvals, 52300–52304 Submissions, and Approvals: Centers for Medicare & Medicaid Services Contribution Operations, 52332–52333 RULES Medicare Programs: Energy Department Hospital Outpatient Prospective Payment and See Federal Energy Regulatory Commission Ambulatory Surgical Center Payment Systems and See Western Area Power Administration Quality Reporting Programs, 52356–52637 NOTICES NOTICES Meetings: Agency Information Collection Activities; Proposals, Supercritical CO2 Oxy-combustion Technology Group, Submissions, and Approvals, 52304–52305 52288 Civil Rights Commission NOTICES Environmental Protection Agency Meetings: PROPOSED RULES Arizona Advisory Committee, 52265 Air Quality State Implementation Plans; Approvals and Promulgations: Coast Guard Maryland; Reasonably Available Control Technology for RULES Cement Kilns, Revisions to Portland Cement Drawbridge Operations: Manufacturing Plant and Natural Gas Compression Delaware River, Tacony, PA, and Palmyra, NJ, 52210 Station Regulations, and Removal of Nitrogen Oxides Safety Zones: Reduction and Trading Program Replaced by Other City of Oswego Fireworks Display; Oswego River, Programs and Regulations, 52259–52262 Oswego, NY, 52210–52212 NOTICES Delaware River; Pipeline Removal; Correction, 52212– Agency Information Collection Activities; Proposals, 52213 Submissions, and Approvals: NOTICES Willingness to Pay Survey to Evaluate Recreational Agency Information Collection Activities; Proposals, Benefits of Nutrient Reductions in Coastal New Submissions, and Approvals, 52315–52316 England Waters, 52297
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Federal Accounting Standards Advisory Board General Services Administration NOTICES NOTICES Issuance of Technical Bulletin: Environmental Impact Statements; Availability, etc.: Intragovernmental Exchange Transactions, 52298 Modernization of the San Luis I Land Port of Entry Technical Bulletins: Modernization, 52299 2017–2, Assigning Assets to Component Reporting Entities, 52297–52298 Health and Human Services Department See Centers for Disease Control and Prevention Federal Energy Regulatory Commission See Centers for Medicare & Medicaid Services See Community Living Administration NOTICES See Food and Drug Administration Applications: See Health Resources and Services Administration Lock 13 Hydro Partners, LLC, 52290 See National Institutes of Health Shell Energy North America (US), LP, 52288–52289 Combined Filings, 52289–52290, 52292–52293 Health Resources and Services Administration Initial Market-Based Rate Filings Including Requests for NOTICES Blanket Section 204 Authorizations: Agency Information Collection Activities; Proposals, GSP Lost Nation LLC, 52293–52294 Submissions, and Approvals: GSP Merrimack LLC, 52290–52291 Assessing Client Factors Associated with Detectable HIV GSP Newington LLC, 52291 Viral Loads; and Models of Care and the Ryan White GSP Schiller LLC, 52292 HIV/AIDS Program, 52309–52311 GSP White Lake LLC, 52293 Be The Match Patient Services Survey, 52311–52312 Luz Solar Partners Ltd., V, 52291–52292 Title V Maternal and Child Health Services Block Grant to States Program; Guidance and Forms for the Title Federal Reserve System V Application/Annual Report, 52312–52314 RULES Voluntary Partner Surveys to Implement Executive Order Federal Reserve Bank Capital Stock, 52173–52174 12862 in the Health Resources and Services NOTICES Administration, 52308–52309 Changes in Bank Control: Charter Renewals: Acquisitions of Shares of a Bank or Bank Holding National Advisory Committee on Rural Health and Company, 52298–52299 Human Services, 52311 Formations of, Acquisitions by, and Mergers of Bank Meetings: Holding Companies, 52298 Advisory Commission on Childhood Vaccines, 52314 Proposals to Engage in or to Acquire Companies Engaged in Permissible Nonbanking Activities, 52298 Homeland Security Department See Coast Guard Fiscal Service Interior Department NOTICES See Fish and Wildlife Service Senior Executive Service Performance Review Board, 52353 See Land Management Bureau See National Indian Gaming Commission Fish and Wildlife Service PROPOSED RULES International Trade Administration Endangered and Threatened Species: NOTICES Threatened Species Status for Chorizanthe parryi var. Antidumping or Countervailing Duty Investigations, Orders, fernandina (San Fernando Valley Spineflower), or Reviews, 52268–52274 52262–52263 Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Food and Drug Administration Aluminum Extrusions from the People’s Republic of RULES China, 52265–52268 Food Additives Permitted in Feed and Drinking Water of Certain Crystalline Silicon Photovoltaic Products from Animals: the People’s Republic of China, 52276–52277 Ammonium Formate and Formic Acid, 52207–52209 Certain Large Diameter Carbon and Alloy Seamless NOTICES Standard, Line and Pressure Pipe from Japan; Certain Guidance: Small Diameter Carbon and Alloy Seamless S5(R3) Detection of Toxicity to Reproduction for Human Standard, Line and Pressure Pipe from Japan and Pharmaceuticals; International Council for Romania, 52275–52276 Harmonisation, 52306–52308 Circular Welded Carbon Quality Steel Pipe From the People’s Republic of China, 52274–52275 Meetings: Foreign Assets Control Office United States Travel and Tourism Advisory Board, RULES 52277–52278 Removal of Cote d’Ivoire Sanctions Regulations, 52209– 52210 International Trade Commission NOTICES Foreign-Trade Zones Board Investigations; Determinations, Modifications, and Rulings, NOTICES etc.: Proposed Foreign-Trade Zones; Application Amendments: Certain Network Devices, Related Software and Hitchcock, TX, 52265 Components Thereof (II), 52318
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Justice Department Meetings: See Antitrust Division Advisory Committee for Biological Sciences, 52333 NOTICES Proposed Consent Decrees: United States v. Black Tea Oil, LLC, et al., 52332 Nuclear Regulatory Commission NOTICES Labor Department Agency Information Collection Activities; Proposals, See Employment and Training Administration Submissions, and Approvals, 52335–52337 See Veterans Employment and Training Service Agency Information Collection Activities; Proposals, Submissions, and Approvals: Land Management Bureau Safeguards on Nuclear Material—Implementation of NOTICES United States/International Atomic Energy Agency Agency Information Collection Activities; Proposals, Agreement, 52334–52335 Submissions, and Approvals: Guidance: Oil Shale Management, 52317–52318 Vital Area Access Controls, Protection of Physical Plats of Survey: Security Equipment, and Key and Lock Controls; Oregon/Washington, 52316–52317 Withdrawal, 52337–52338 Library of Congress Meetings: See Copyright Office, Library of Congress Advisory Committee on Reactor Safeguards Subcommittee on APR1400, 52335 National Indian Gaming Commission Advisory Committee on Reactor Safeguards PROPOSED RULES Subcommittee on Regulatory Policies and Practices, Fees, 52253–52258 52338 National Institute of Food and Agriculture PROPOSED RULES Presidential Documents Matching Funds Requirements for Agricultural Research PROCLAMATIONS and Extension Capacity Funds at 1890 Land-Grant Special Observances: Institutions and 1862 Land-Grant Institutions in Insular Veterans Day (Proc. 9672), 52639–52642 Areas, 52250–52253 National Institutes of Health Procurement and Property Management Office, NOTICES Agriculture Department Meetings: NOTICES National Institute of Allergy and Infectious Diseases, Agency Information Collection Activities; Proposals, 52315 Submissions, and Approvals, 52264 National Oceanic and Atmospheric Administration RULES Securities and Exchange Commission Fisheries of the Caribbean, Gulf of Mexico, and South NOTICES Atlantic: Agency Information Collection Activities; Proposals, Gulf Gray Triggerfish; Commercial Accountability Submissions, and Approvals, 52338–52339, 52351 Measure and Closure, 52248 Applications: Fisheries of the Northeastern United States: CBOE Vest Financial, LLC, et al., 52339–52340 Atlantic Bluefish Fishery; Quota Transfer, 52249 Self-Regulatory Organizations; Proposed Rule Changes: NOTICES MIAX PEARL, LLC, 52342–52343 Agency Information Collection Activities; Proposals, Nasdaq PHLX LLC, 52340–52342 Submissions, and Approvals, 52282 New York Stock Exchange LLC, 52344–52347 Agency Information Collection Activities; Proposals, NYSE American LLC, 52349–52350 Submissions, and Approvals: NYSE Arca, Inc., 52347–52349 Alaska Chinook Salmon Economic Data Report, 52280 Customer Surveys, 52279–52280 Monitoring Programs for Vessels in the Pacific Coast Small Business Administration Groundfish Fishery, 52284 RULES Exempted Fishing Permit; Applications: Small Business Investment Companies: Magnuson-Stevens Act Provisions; General Provisions for Administrative Fees, 52174–52186 Domestic Fisheries, 52282–52283 NOTICES Meetings: Disaster Declarations: Fisheries of the South Atlantic; South Atlantic Fishery Oregon, 52352 Management Council, 52278–52279 Major Disaster Declarations: Fisheries of the South Atlantic; Southeast Data, Puerto Rico; Amendment 2, 52352–52353 Assessment, and Review, 52283–52284 Puerto Rico; Public Assistance Only, 52352 New England Fishery Management Council, 52278, 52280–52281 Tennessee Valley Authority National Science Foundation NOTICES NOTICES Meetings: Antarctic Conservation Act Permits, 52333–52334 Regional Energy Resource Council, 52353
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Transportation Department Separate Parts In This Issue RULES Procedures for Transportation Workplace Drug and Alcohol Testing Programs: Part II Addition of Certain Schedule II Drugs to the Department Health and Human Services Department, Centers for of Transportation’s Drug-Testing Panel and Certain Medicare & Medicaid Services, 52356–52637 Minor Amendments, 52229–52248 Part III Treasury Department Presidential Documents, 52639–52642 See Fiscal Service See Foreign Assets Control Office Veterans Employment and Training Service Reader Aids RULES Honoring Investments in Recruiting and Employing Vets Consult the Reader Aids section at the end of this issue for Medallion Program, 52186–52207 phone numbers, online resources, finding aids, and notice of recently enacted public laws. Western Area Power Administration To subscribe to the Federal Register Table of Contents NOTICES electronic mailing list, go to https://public.govdelivery.com/ Rate Orders: accounts/USGPOOFR/subscriber/new, enter your e-mail Boulder Canyon Project, 52294–52297 address, then follow the instructions to join, leave, or manage your subscription.
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CFR PARTS AFFECTED IN THIS ISSUE
A cumulative list of the parts affected this month can be found in the Reader Aids section at the end of this issue.
3 CFR Proclamations: 9672...... 52641 7 CFR Proposed Rules: 3419...... 52250 12 CFR 209...... 52173 13 CFR 107...... 52174 20 CFR 1011...... 52186 21 CFR 573...... 52207 25 CFR Proposed Rules: 514...... 52253 31 CFR 543...... 52209 33 CFR 117...... 52210 165 (2 documents) ...... 52210, 52212 37 CFR 201 (2 documents) ...... 52213, 52221 202...... 52224 Proposed Rules: 201...... 52258 202...... 52258 40 CFR Proposed Rules: 52...... 52259 42 CFR 414...... 52356 416...... 52356 419...... 52356 49 CFR 40...... 52229 50 CFR 622...... 52248 648...... 52249 Proposed Rules: 17...... 52262
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Rules and Regulations Federal Register Vol. 82, No. 217
Monday, November 13, 2017
This section of the FEDERAL REGISTER Federal Reserve Act 1 and Regulation I,2 year, published by the Bureau of contains regulatory documents having general a member bank must subscribe to Economic Analysis.’’ 8 applicability and legal effect, most of which capital stock of the Reserve Bank of its II. Adjustment are keyed to and codified in the Code of district in an amount equal to six Federal Regulations, which is published under The Board annually adjusts the $10 50 titles pursuant to 44 U.S.C. 1510. percent of the member bank’s capital and surplus. The member bank must billion total consolidated asset The Code of Federal Regulations is sold by pay for one-half of this subscription on threshold based on the change in the the Superintendent of Documents. the date that the Reserve Bank approves Gross Domestic Product Price Index its application for capital stock, while between the second quarter of 2015 (the the remaining half of the subscription baseline year) and the second quarter of 9 FEDERAL RESERVE SYSTEM shall be subject to call by the Board.3 the current year. The second quarter 2017 Gross Domestic Product Price 12 CFR Part 209 Section 7(a)(1) of the Federal Reserve Index estimate published by the BEA in Act 4 provides that Reserve Bank [Regulation I; Docket No. R–1560] September 2017 (113.037) is 2.83% stockholders with $10 billion or less in higher than the second quarter 2015 RIN 7100–AE 68 total consolidated assets shall receive a Gross Domestic Product Price Index six percent dividend on paid-in capital estimate published by the BEA in Federal Reserve Bank Capital Stock stock, while stockholders with more September 2017 (109.921). Based on this than $10 billion in total consolidated AGENCY: Board of Governors of the change in the Gross Domestic Product Federal Reserve System. assets shall receive a dividend on paid- Price Index, the threshold for total in capital stock equal to the lesser of six ACTION: Final rule. consolidated assets in Regulation I will percent and ‘‘the rate equal to the high be $10,283,000,000 as of the effective SUMMARY: The Board of Governors yield of the 10-year Treasury note date of January 1, 2018. (Board) is publishing a final rule that auctioned at the last auction held prior III. Administrative Law Matters applies an inflation adjustment to the to the payment of such dividend.’’ threshold for total consolidated assets in Section 7(a)(1) requires that the Board Administrative Procedure Act adjust the threshold for total Regulation I. Federal Reserve Bank The provisions of 5 U.S.C. 553(b) consolidated assets annually to reflect (Reserve Bank) stockholders that have relating to notice of proposed the change in the Gross Domestic total consolidated assets above the rulemaking have not been followed in Product Price Index, published by the threshold receive a different dividend connection with the adoption of these BEA. rate on their Reserve Bank stock than amendments. The amendments involve stockholders with total consolidated Regulation I implements section expected, ministerial adjustments that assets at or below the threshold. The 7(a)(1) of the Federal Reserve Act by (1) are required by statute and Regulation I Federal Reserve Act requires that the defining the term ‘‘total consolidated and are consistent with a method Board annually adjust the total assets,’’ 5 (2) incorporating the statutory previously set forth by the Board.10 consolidated asset threshold to reflect dividend rates for Reserve Bank Accordingly, the Board finds good cause the change in the Gross Domestic stockholders 6 and (3) providing that the for determining, and so determines, that Product Price Index, published by the Board shall adjust the threshold for total notice in accordance with 5 U.S.C. Bureau of Economic Analysis (BEA). consolidated assets annually to reflect 553(b) is unnecessary. Based on the change in the Gross the change in the Gross Domestic Regulatory Flexibility Act Domestic Product Price Index as of Product Price Index.7 The Board has September 28, 2017, the total explained that it ‘‘expects to make this The Regulatory Flexibility Act (RFA) consolidated asset threshold will be adjustment [to the threshold for total does not apply to a rulemaking where a $10,283,000,000 through December 31, consolidated assets] using the final general notice of proposed rulemaking 2018. second quarter estimate of the Gross is not required.11 As noted previously, DATES: This final rule is effective Domestic Product Price Index for each the Board has determined that it is January 1, 2018. unnecessary to publish a general notice 1 of proposed rulemaking for this final FOR FURTHER INFORMATION CONTACT: 12 U.S.C. 287. 2 rule. Accordingly, the RFA’s Evan Winerman, Counsel (202/872– 12 CFR 209.4(a). 3 requirements relating to an initial and 7578), Legal Division; or Kimberly 12 U.S.C. 287 and 12 CFR 209.4(c)(2). 4 12 U.S.C. 289(a)(1). Zaikov, Financial Project Leader (202/ 5 12 CFR 209.1(d)(3) (‘‘Total consolidated assets 8 81 FR 84415, 84417 (Nov. 23, 2016). 452–2256), Reserve Bank Operations means the total assets on the stockholder’s balance 9 The BEA makes ongoing revisions to its and Payments Systems Division. For sheet as reported by the stockholder on its estimates of the Gross Domestic Product Price Index users of Telecommunications Device for Consolidated Report of Condition and Income (Call for historical calendar quarters. The Board the Deaf (TDD) only, contact (202) 263– Report) as of the most recent December 31, except calculates annual adjustments from the baseline in the case of a new member or the surviving year (rather than from the prior-year total 4869. stockholder after a merger ‘total consolidated assets’ consolidated asset threshold) to ensure that the SUPPLEMENTARY INFORMATION: means (until the next December 31 Call Report adjusted total consolidated asset threshold becomes available) the total consolidated assets of accurately reflects the cumulative change in the I. Background the new member or the surviving stockholder at the BEA’s most recent estimates of the Gross Domestic time of its application for capital stock’’). Product Price Index. Regulation I governs the issuance and 6 12 CFR 209.4(e), (c)(1)(ii), and (d)(1)(ii); 10 See 12 CFR 209.4(f) and n. 8 and accompanying cancellation of capital stock by the 209.2(a); and 209.3(d)(3). text, supra. Reserve Banks. Under section 5 of the 7 12 CFR 209.4(f). 11 5 U.S.C. 603 and 604.
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final regulatory flexibility analysis do SBA last increased fees for SBICs in licensing and examinations), and not apply. 1996. Current fees offset less than 40% excludes SBA’s overhead costs (e.g., of SBA’s administrative expenses office space, utilities, and other Paperwork Reduction Act related to these activities. This final rule supporting offices within SBA). In FY In accordance with the Paperwork increases SBIC licensing and 2016, licensing and examination fees Reduction Act of 1995,12 the Board has examination fees in annual steps reimbursed approximately 35% of reviewed this final rule. No collections through October 2020, at which time SBA’s direct licensing and examination of information pursuant to the SBA estimates that the annual fees will expenses, and less than a quarter of Paperwork Reduction Act are contained recoup approximately 80% of SBA’s SBA’s licensing and examination in the final rule. annual expenses directly related to expenses when including overhead. On December 16, 2016, SBA List of Subjects in 12 CFR Part 209 these activities. Beginning in October 2021, this rule increases licensing and published a proposed rule (81 FR Banks and banking, Federal Reserve examination fees annually based on 91049) to gradually increase the SBIC System, Reporting and recordkeeping inflation. licensing and examination fees each requirements, Securities. year through October 1, 2020, and DATES: This rule is effective December thereafter annually based on inflation, Authority and Issuance 13, 2017. beginning on October 1, 2021. The For the reasons set forth in the FOR FURTHER INFORMATION CONTACT: proposed rule detailed the reasons for preamble, the Board amends Regulation Theresa Jamerson, Office of Investment the widening gap between fees received I, 12 CFR part 209, as follows: and Innovation, (202) 205–7563 or sbic@ and SBA related expenses. Key reasons sba.gov. include inflation, changes in the SBIC PART 209—ISSUE AND SUPPLEMENTARY INFORMATION: portfolio, increased capital at risk (SBA- CANCELLATION OF FEDERAL I. Background Information guaranteed leverage and commitments), RESERVE BANK CAPITAL STOCK SBA’s efforts to improve SBIC program (REGULATION I) The Small Business Investment Act of performance, and technology 1958, as amended (‘‘Act’’), authorizes ■ 1. The authority citation for part 209 implementation. SBA to collect fees to cover the costs As noted above, the Act authorizes continues to read as follows: associated with the licensing and SBA to collect fees to cover the costs Authority: 12 U.S.C. 12 U.S.C. 222, 248, examination of SBICs. 15 U.S.C. associated with the licensing and 282, 286–288, 289, 321, 323, 327–328, and 681(e)(2)(B) and 687b(b). Although SBA examination of SBICs. The Act requires 466. has regulations setting the amount of SBA to deposit the fees in the account ■ 2. In part 209, remove all references to these fees, SBA has not increased for salaries and expenses of the ‘‘$10,122,000,000’’ and add in their licensing and examination fees for Administration and authorizes SBA to place ‘‘$10,283,000,000’’, wherever they SBICs since 1996. As part of the final use licensing fees to cover licensing appear. rule published January 31, 1996 (61 FR costs and examination fees to cover the By order of the Board of Governors of the 3177), SBA set licensing fees ‘‘to reflect costs of examinations and other program Federal Reserve System, acting through the the Agency’s costs of processing oversight activities. 15 U.S.C. 681(e)(2) Secretary of the Board under delegated applications’’ and similarly set and 687b(b). To the extent that SBA authority, November 7, 2017. examination fees to ‘‘produce total does not cover its licensing and Margaret M. Shanks, revenue sufficient to cover the current examination costs by charging SBICs for Deputy Secretary of the Board. direct costs to SBA of conducting these fees, the balance is paid out of [FR Doc. 2017–24553 Filed 11–9–17; 8:45 am] examinations.’’ In a subsequent rule Agency funds. In other words, when published on April 30, 1997 (62 FR BILLING CODE 6210–01–P SBICs do not pay fees sufficient to cover 23337), SBA capped examination fees at SBA’s licensing and examination costs, $14,000, which lowered the fee for taxpayers bear the burden of covering SBICs with over $60 million in assets. SMALL BUSINESS ADMINISTRATION those costs. It is an appropriate use of As part of the rationale for this change, SBA’s statutory authority in this final 13 CFR Part 107 the rule stated, ‘‘many of the largest rule to increase SBIC licensing and SBICs are bank-owned and do not use examination fees to cover a greater RIN 3245–AG65 federal leverage, so that fees computed percentage of licensing and examination on the basis of total assets do not costs. Small Business Investment appropriately reflect the level of effort The effect of the statutory language Companies—Administrative Fees and risk associated with the authorizing SBA to use licensing fees to AGENCY: U.S. Small Business examination process.’’ Neither rule cover licensing costs and examination Administration. included an adjustment for inflation. fees to cover the costs of examinations ACTION: Final rule. Although fees set in 1996, as adjusted and ‘‘other program oversight activities’’ in 1997, were intended to fully is that SBA may use examination fees to SUMMARY: The U.S. Small Business reimburse SBA’s costs, by fiscal year cover a broader category of expenses Administration (SBA) is revising its (FY) 1999 (the earliest fiscal year for than those for which it may charge (i.e., regulations to increase the Small which SBA expenses are readily examination costs alone). Although the Business Investment Company (SBIC) available), licensing and examination current and estimated future costs of licensing and examination fees. The fees only covered approximately 85% of compensation and benefits of SBA Small Business Investment Act of 1958, SBA’s direct costs. SBA’s direct costs personnel involved in licensing and as amended, allows SBA to collect are the expenses related to licensing and examinations, not including any licensing and examination fees to offset examination (e.g., personnel additional related expenses, fully SBA’s costs associated with the compensation and benefits associated support the fee increases in this final administration of these two activities. with licensing and examinations, rule, in the proposed rule, SBA technology, subscription services, travel identified a number of costs it expected 12 44 U.S.C. 3506; 5 CFR part 1320. and other costs associated with to pay for with the funds made available
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by this rule, such as technology, asked what assurances SBA could rulemaking and should provide training, information services and provide that the fee increase would assurance that the additional funds contractor support for examinations. benefit the SBIC program. A final made available by this final rule will be While the expenses other than licensing comment stated that ‘‘OII should use all used to benefit the SBIC program. As and examinations personnel its resources to support the SBIC more fully discussed below, SBA compensation and benefits discussed in program.’’ intends to allocate the additional funds the proposed rule and this final rule are The comments misunderstand or fail made available by this rule to pay for not necessary to support the fee to take into account SBA’s statutory needed resources, including technology, increases in this final rule, these obligations, extensive transparency with subscription services, contractors, and expenses are priorities of SBA. respect to spending, and commitments training. Finally, and more broadly, the Accordingly, SBA intends to use the identified in the proposed rule. First, by SBIC program is one of many programs additional funds made available by this statute, SBA must use SBIC licensing operated by SBA. OII manages several rule—whether those funds are fee fees for licensing expenses and SBIC programs, including, but not limited to, revenue or Agency funds currently used examination fees for examination and the SBIC program and the SBIR to pay compensation and benefits of other program oversight expenses. 15 program. As is the case with the SBIC personnel involved in licensing and U.S.C 681(e)(2)(A), 687b(b). This program, SBA has statutory obligations examinations that are replaced by fee statutory obligation governing the use of with respect to operating the SBIR revenue from this rule—to pay for such fees should provide SBICs with program. SBA assesses resource needs expenses. certainty that SBA is using the fees for each program to efficiently and SBA received three sets of comments. generated by this final rule only for effectively execute its statutory These comments are addressed in the SBIC matters. Second, SBA provides responsibilities. Consistent with the Section-by-Section Analysis. comprehensive budget transparency, statute, no SBIC fee revenue has been or will be used for this program. II. Section-by-Section Analysis which should provide additional assurance to SBICs that SBA is using the One comment stated that SBIC A. General Comments on the Proposed fee increase in the final rule only for program costs have not substantially Rule SBIC matters. SBA’s Congressional increased in recent years and SBA received several comments that Budget Justification separately tracks questioned the need for increased fees. were generally directed to the proposed and reports the costs for each of its The comment is correct that SBIC rule (81 FR 91049) rather than a specific programs, including the costs of the program costs have not substantially section. Each of these is addressed SBIC and SBIR programs. This increased over the past few years. below. information is made publicly available Nonetheless, excluding SBA overhead, One comment stated that the every year by SBA, and is available at the SBIC program direct operating proposed rule does not comply with the www.sba.gov/about-sba/sba- budget has increased from $7.4 million Presidential Executive Order 13771 performance/performance-budget- in FY 1999 (the earliest period for issued on January 30, 2017, entitled finances/congressional-budget- which SBIC budgets are readily ‘‘Reducing Regulation and Controlling justification-annual-performance-report. available) to approximately $12.9 Regulatory Costs.’’ OMB issued Current SBIC licensing and examination million in FY 2016. Over half of the guidance on April 5, 2017, entitled, fees are applied to SBA’s account for increase is due to inflation ($7.4 million ‘‘Guidance Implementing Executive salaries and expenses, as required by the in January 1999 would equate to $10.7 Order 13771,’’ which states that Act, and are used to pay the salaries of million in January 1999 based on the Executive Order 13771 applies only to personnel associated with SBIC U.S. Bureau of Labor Consumer Price significant rules, as defined by section licensing and examination activities. In Index calculator located at data.bls.gov/ 3(f) of Executive Order 12866. Since FY 2016, SBA spent an estimated $4.8 cgi-bin/cpicalc.pl) with the remainder OMB has determined that this rule is million on personnel compensation and due to the addition of subscription not significant, Executive Order 13771 benefits associated with these activities services, such as Preqin and Lexis/ does not apply to this rule. alone, and $5.4 million including travel, Nexis, technology improvements, and SBA received a number of comments technology, subscription services and the costs associated with more that centered on the theme that SBA is other costs associated with these experienced analysts necessary to using dollars that should be directed to activities. Licensing and examination oversee SBA’s increased capital at risk the SBIC program for other programs. fees provided only $1.9 million to offset (SBA leverage and commitments). As For example, one comment stated that these costs. By FY 2021, SBA estimates discussed in the proposed rule, SBICs SBA’s Office of Investment and that direct costs associated with ultimately benefit financially from Innovation (OII), which oversees the licensing and examinations will improvements in the quality of the SBIC SBIC program, has been redirecting its increase to $9.4 million and that this program portfolio through lower annual human capital and funding from the final rule will generate an additional $5 charges on SBA-guaranteed debenture SBIC program to other programs, such to $6 million in fees annually. leverage. The SBIC debenture leverage as the Small Business Innovation Accordingly, even after the fee increases annual charge has decreased from 1% in Research (SBIR) program. Another in this rule are fully phased in, a FY 1999 to an annual charge of 0.347% comment stated that SBICs have no shortfall of $1.5 million to $2.5 million in FY 2017, reflecting improvements to certainty that if higher fees are charged will still exist between aggregate the SBIC debenture portfolio (a cost that the additional resources generated licensing and examination direct savings of $979,500 in just one year for would not be used to offset increased expenses. When factoring in overhead, a hypothetical SBIC issuing $150 spending for non-SBIC matters, and SBA’s estimated licensing and million of debentures at the lower ‘‘there is no limitation on monies that examination costs will even further annual charge). In FY 1999, SBA had are currently spent on licensing and exceed anticipated fees. Third, SBA less than $3.9 billion in capital at risk; examinations from being diverted to recognizes the need for additional this figure grew to $14.5 billion by the other uses by the SBA.’’ Another resources in the SBIC program. Indeed, end of FY 2016. Analyzing SBICs and comment stated similar concerns and that is one of the purposes of the SBIC applicants has become more time
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intensive due to the increased to pay for the additional and necessary established a goal of increasing the complexity of SBIC organizational expenses identified in the proposed frequency with which individual SBICs structures, legal documents, rule. As discussed above, in FY 2016, are examined to further reduce risk of management fees, and financings. As an SBA expended approximately $5.4 loss to the SBIC program. Due to staffing example, on October 21, 2014, SBA million, excluding overhead, on SBIC limitation issues, SBA intends to published a final rule (79 FR 62819) licensing and examination activities, but outsource certain examination functions requested by the SBIC industry, which received only $1.9 million in licensing in order to ensure that it is able to meet allowed the use of up to two levels of and examination fees, resulting in a $3.5 statutory examination requirements. passive businesses under 13 CFR million shortfall which was paid out of (3) Travel: SBA intends to increase 107.720(b)(2) in order to provide more SBA’s taxpayer-funded budget. Through staff travel in furtherance of program flexibility to its SBICs in structuring this rule, SBA expects to reduce this objectives for licensing, examinations, investments. To appropriately monitor shortfall. and other program oversight activities. these financings, SBA must examine One comment suggested that SBA (4) Training: As noted in the proposed each passive business used in the should conduct an in-depth accounting rule, the Office of Inspector General financing in addition to the operating of the needs and requirements of OII to (OIG) noted that ‘‘without proper business. While SBA understands such provide ‘‘first-class service’’ to SBICs to training and technology examiners may financings provide SBICs additional determine the minimum resources not effectively identify all regulatory flexibility in structuring investments, necessary to fulfill its mission, identify violations as intended by the Act.’’ OIG these financings cause additional work where costs can be cut, better allocate Audit Report 13–22 at 11. OII intends to for SBA to review and monitor. existing resources, improve efficiencies devote a larger portion of its budget for One comment asked SBA to identify through private sector solutions, and employee training. its priorities for the increased fee then present the final accounting of (5) Subscription Services: SBA is revenue associated with this rule. SBA these amounts to the public. Regarding evaluating information sources used by intends to use the additional funds the in-depth accounting requested by a typical private sector private equity made available by this rule to: (1) the comment, the proposed rule set fund of funds to identify which sources Support its continued efforts to migrate forth in detail current licensing and may most effectively help its analysts from desktop database tools to a secure examination expenses and the better evaluate and assess SBICs and cloud-based system comparable to the additional expenses related to these applicants. systems used by a typical private equity functions that SBA believes are critical SBA regularly assesses needs and fund of funds (an investment fund that to fulfilling the statutory mission of the resources for all programs to ensure that holds a portfolio of private equity SBIC program. This final rule discusses SBA is able to meet its statutory funds); (2) pay for additional contractor those costs and future estimates in obligations in an efficient and effective services to support examinations and further detail. In reviewing existing manner. In assessing the expenses of the facilitate SBA’s transition to a paperless resources, SBA identified five key areas SBIC program more broadly than environment; (3) increase travel related for improvements, which it intends to licensing and examination expenses to licensing, examination, and other pay for using the additional funds made alone, total program costs for the SBIC program oversight; (4) train employees; available as a result of this final rule, as program are already low compared to (5) increase access to subscription follows: cost of the SBIC program from prior eras services typically used by a typical (1) Technology: SBA’s Office of the based on capital at risk and comparable private equity fund of funds, such as Chief Information Officer (OCIO) is current private sector entities based on industry reports; and (6) to further offset working closely with OII to improve its assets under management. SBIC the compensation and benefits of systems to provide functionality similar program resources have not kept pace personnel associated with these to a typical private sector private equity with increased capital at risk since FY activities. fund of funds and serve as a virtual data 1999 (the earliest period for which the One comment stated that the room. In addition to this software, SBA SBIC program operating budget is proposed fee increase was excessive and needs to migrate from Microsoft Access readily available). In FY 1999, SBA it was unclear why an additional $3 to and acquire data visualization and spent $7.4 million, excluding overhead, $4 million in fees is needed to analytical tools commensurate with to manage a portfolio of less than $3.9 administer the program, noting that the private equity funds and other billion in capital at risk (leverage and costs cited in the proposed rule only government loan programs. SBA also commitments); in FY 2016, SBA spent totaled $1.7 million. As support, the expects to periodically update its $12.9 million to manage a portfolio of comment cited the $100,000 in hardware. $14.5 billion. SBA’s capital at risk information subscription services, (2) Outsourced Contractor Services: continues to increase, reaching $15.3 $500,000 in increased licensing and SBA intends to utilize contractors to billion as of May 22, 2017. While SBA’s examination costs for technology provide certain services for which SBA capital at risk has more than tripled in improvements, $100,000 to incur does not currently have sufficient size, SBA’s costs to manage its much additional training costs, and $1 million resources to perform and to assist in larger portfolio have not even doubled. in contracting resources identified in certain risk control functions of OII. As a result, the SBIC program’s FY 1999 the proposed rule. This includes hiring contractors for operating budget, excluding overhead, Setting aside the $1.7 million in scanning, file management, record represented 0.19% of its capital at risk specific additional expenses needed for management, and cyber security to help and its FY 2016 operating budget licensing and examination expenses migrate the entire office to a paperless represents 0.09%. If SBA returned to the identified in the proposed rule, the environment. This also includes FY 1999 rate of 0.19%, the SBIC commenter appears to disregard the valuation services to help support SBIC program’s direct budget would need to licensing and examination expenses that program oversight and SBIC increase to $29 million today, which current fees are not covering. The intent examinations where SBA determines would still fall significantly below of this final rule is to cover more of that an independent valuation is comparable private sector costs. As a SBA’s existing expenses for these appropriate or necessary. In reviewing comparison, a typical private sector activities and provide sufficient income the examination function, SBA has fund of funds commonly charges 1% of
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assets under management (AUM) TABLE 1—SBIC PROGRAM DIRECT Direct licensing costs are expected to annually to manage the fund; notably, COST ESTIMATES increase from approximately $2 million SBICs typically charge 2% in annual [In millions of dollars] in FY 2016 to almost $3 million by FY management fees. 2021, and examination costs are expected to increase from $3.4 million SBA estimates that by FY 2021 the Category FY FY Agency will need approximately $19.9 2016 2021 in FY 2016 to almost $6.4 million by FY 2021. Table 2, SBIC Program Direct Cost million, excluding overhead, to manage Personnel (Compensation the SBIC program (‘‘SBIC Program & Benefits) ...... $11.65 $13.53 Estimates for Licensing and Direct Cost Estimates’’), as shown in Technology ...... 0.79 3.16 Examination Activities (In Millions of Table 1, SBIC Program Direct Cost Outsourced Contractor Dollars), below provides a breakdown Estimates (In Millions of Dollars), Services ...... 2.29 for SBIC licensing and examination Travel ...... 0.22 0.47 costs. below. The cost estimate includes Subscription Services ...... 0.19 0.21 increases for inflation through FY 2021 Training and Other Ex- and funding for the five key areas that penses ...... 0.09 0.27 are targeted for improvement. Total SBIC Program Direct Cost Esti- mates ...... 12.94 19.93
TABLE 2—SBIC PROGRAM DIRECT COST ESTIMATES FOR LICENSING AND EXAMINATION ACTIVITIES [In millions of dollars]
Licensing costs Examination costs Category FY 2016 FY 2021 FY 2016 FY 2021
Personnel (Compensation & Benefits) ...... $1.80 $2.31 $2.96 $4.12 Technology ...... 0.09 0.31 0.20 0.79 Outsourced Contractor Services ...... 0.00 0.11 0.00 1.11 Travel ...... 0.00 0.06 0.22 0.26 Subscription Services ...... 0.12 0.13 0.00 0.00 Training and Other Expenses ...... 0.01 0.03 0.02 0.07
Total SBIC Direct Cost Estimates ...... 2.02 2.95 3.40 6.35
SBA realized that the cost estimates result, the fee increase in this final rule to maximize efficiency and prioritize on which the proposed rule was is likely to cover less of SBA’s license resources. Based on this review, SBA is developed (‘‘proposed rule cost and examination expenses than SBA currently seeking to provide additional estimate’’) significantly underestimated expected when proposing the rule. After resources to licensing and examinations. SBA costs for technology, outsourcing, the full increase is phased in by FY One comment stated that although and overhead. The proposed rule 2021, the fees will cover approximately more staffing resources should be identified only $1 million for 80% of SBA’s direct licensing and allocated to SBIC examinations, those technology, half of which was allocated examination expenses, and less than resources should come from other areas to licensing and examinations. After 60% of such expenses when including within OII or sought from congressional further review of commercially available overhead. SBA is concerned that the appropriations. SBA assesses the needs systems used by private sector funds of phased in fee increase in this final rule for all of its programs and cannot funds and tools used by other may not provide SBA with fees reallocate money from one program to government financial programs, SBA necessary to pay for critical resources as another without repercussions to the believes technology costs are likely to be quickly as necessary. SBA is also program that would lose resources. In significantly higher than originally concerned that, after the phase-in is addition, any reallocations of personnel estimated in the proposed rule. The complete, fees collected will not cover to examination functions would not proposed rule cost estimate also all expenses authorized by statute. lower examination costs. Such understated costs for outsourced Accordingly, SBA is considering resources, therefore, would not reduce services, particularly with respect to proposing a new rule after this final rule the need for the fees set forth in this examinations and cyber security. Most becomes effective to more fully cover its final rule. SBA could request additional significantly, the proposed rule used an licensing and examination costs in a funds from Congress; however, Congress agency overhead rate of less than half a more expedited timeframe. gave SBA the authority to recoup its percent (0.48%) of all direct SBIC costs. One comment questioned OII’s SBIC licensing and examination After publishing the proposed rule, OII priorities, stating that OII recently expenses by charging SBIC licensing became aware that the actual agency created and hired a position which the and examination fees. By this final rule, overhead rate amounts to approximately commenter believes duplicates a SBA is complying with the statutory thirty percent (30%) of the program’s currently existing role in OII rather than intent to cover more of its licensing and total cost. (For example, if the total filling core competencies. How SBA examination costs through the use of program cost were $10 million, $7 chooses to allocate its non-fee related fees, which will provide SBA with the million would be the program office’s budget is not the subject of this rule. In ability to pay for necessary additional direct costs while the other $3 million addition, as noted above, SBA regularly resources required to administer the would represent agency overhead.) As a reviews resource allocations within SBA SBIC program.
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Two comments noted that technology assets at cost would be $44,000 (0.03% with the statutory authority Congress improvements, such as a virtual data of assets) and for a non-leveraged SBIC provided to SBA in Sections 301 and room, could significantly reduce costs. $30,000 (0.02% of assets). SBA’s goal is 310 of the Act, SBICs, not taxpayers, are Neither commenter provided data to to examine leveraged SBICs every paying the costs related to these support cost reductions. As part of the twelve months and non-leveraged SBICs activities. SBA estimates that if SBA had budget estimate presented in Table 1, every eighteen months. In FY 2016, an instituted an inflation adjustment in SBA considered the use of private sector SBIC with $150 million in assets 1996, over the 5-year period between technology, such as adopting software typically incurred annual management FYs 2012 and 2016 alone, SBA could commonly used by a typical private fees of $3 million and annual audit fees have saved taxpayers over $6 million. equity fund of funds, virtual data rooms, between $50,000 and $60,000. SBA Further, SBA’s budget process ensures and analytical tools to improve the believes that while the increased fees accountability by providing disclosure efficiency of its processes. In general, may deter a few funds with limited of SBA’s costs to the public each year. SBA has found that while technology ability to raise capital from applying to SBA further notes that using inflation improves the accessibility of the program, most applicants will not be adjustments is in line with other federal information, it does not necessarily deterred. To the extent that such financial regulators such as bank decrease the time or manpower required deterrence occurs, it may help SBA examiner fees (For example, pursuant to to license or examine a fund. For focus its resources on stronger SBIC 12 CFR 8.2, the Office of the example, while a virtual data room applicants. Comptroller of the Currency applies an would help in accessing a business inflation adjustment to the fees it B. Indexing Fees plan, it takes the same amount of time charges for examining and supervising to read and understand the business Section 107.50—Definition of Terms national banks.) Finally, SBA remains plan in an electronic version as a paper Current SBIC regulations do not committed to ensuring that the SBIC version. Similarly, while a virtual data adjust SBA’s administrative fees for program is operated efficiently and room helps SBA access SBIC financing inflation. As a result, fees have not effectively. This final rule adopts the documents, most of SBA’s time is spent increased since 1996 and do not cover proposed § 107.50 language without reviewing the documents, and assessing SBA’s costs. To enable fees to remain change. whether the financing complies with current with inflation, SBA is adding C. Licensing Fees SBIC regulations. SBA also notes that the term ‘‘Inflation Adjustment’’, which such technology is used by SBIC is defined as the methodology used to Section 107.300—License Application managers and other professionals (such increase SBIC administrative fees using Form and Fee as accounting and law firms) that charge the consumer price index for all urban Current regulations require SBIC expenses to SBICs and that their costs consumers (CPI–U), as calculated by the applicants to pay a licensing fee when have not declined. U.S. Bureau of Labor and Statistics submitting a complete application. One comment stated that the (BLS), based on the U.S. city average for Under those regulations, the licensing increased fees would significantly deter all items, not seasonally adjusted, with fee consisted of a base fee of $10,000 existing and prospective SBIC fund the base period 1982 ¥ 84 = 100. plus additions as follows: $5,000 if the managers from continuing in the Beginning on October 1, 2021, and prior applicant intended to operate as a program. The fees identified in this final to each federal government fiscal year limited partnership; $5,000 if the rule represent a small percentage of a (October 1) thereafter, SBA would applicant intended to issue Participating fund’s capital or expenses. Regarding recalculate the examination and Securities leverage (a type of leverage no the licensing fees, in FY 2016, SBA licensing fees to reflect increases in the longer available); and $10,000 if the licensed 21 SBICs with average initial CPI–U based on the change in the index applicant intended to be licensed as an private capital exceeding $55 million. from the June CPI–U in the previous Early Stage SBIC (a type of license no Those intending to issue SBA year to the most recent June CPI–U. For longer issued after September 30, 2016). guaranteed debentures (‘‘leveraged example, the CPI–U is 238.638 in June SBA proposed to remove the SBICs’’) had average initial private 2015 and 241.038 in June 2016; a additions and to adopt a uniform capital of $53 million, and those not 1.0057% increase would be applied and licensing fee of $25,000 in FY 2017, intending to issue SBA guaranteed then rounded to the nearest $100. If the which would increase by $5,000 each debentures (‘‘non-leveraged SBICs’’) had CPI–U decreases, no change would be October through October 1, 2020, average initial capital of $74 million. made to the fees. SBA would publish resulting in a licensing fee of $45,000 by The FY 2021 licensing fee of $45,000 the resulting fees in a notice in the October 1, 2020. Beginning on October represents 0.06% of the average non- Federal Register each year prior to 1, 2021, the rule proposed to increase leveraged SBIC’s capital and 0.03% of October 1. the amount based on inflation. The the leveraged SBIC’s total capital SBA received one comment that proposed rule did not propose changing (assuming the leveraged SBIC will draw opposed the inflation adjustment, when the licensing fee was payable. leverage equal to two times private stating that instituting an inflation Consistent with SBA’s existing practice, capital). Even after full phase-in by FY adjustment removes SBA’s the preamble to the proposed rule 2021, the licensing fee is expected to accountability for reducing costs and discussed SBA’s licensing phases and account for a modest percentage of an streamlining processes. SBA does not what forms and fees are required at each SBIC’s total organizational costs (e.g., agree. More than half of SBA’s SBIC phase as follows: legal fees and other professional and expense increase between 1999 and The first phase in the licensing consulting services, fundraising 2016 was due to inflation. These process (‘‘Initial Review’’) begins when expenses, etc.), which frequently reach increased expenses were funded by a first time applicant submits its or exceed $500,000. Regarding the taxpayers rather than SBICs. Management Assessment Questionnaire examination fee, under this final rule, in Implementing an inflation adjustment to (‘‘MAQ’’), which consists of SBA Forms approximately three years (by October ensure that SBA’s licensing and 2181 and Exhibits A through F of SBA 2020), the examination fee for a examination fees keep pace with Form 2182, or when the management of leveraged SBIC with $150 million in inflation helps to ensure that, consistent an existing SBIC submits a request to
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SBA to be considered for a subsequent raising sufficient private capital. A helps applicants identify whether they SBIC license. (SBIC application forms number of applicants fail to raise the are likely to qualify for a license before are available on SBA’s Web site at requisite capital or for other reasons do beginning the licensing process. www.sba.gov/sbic.) SBA reviews the not submit a license application. As a SBA agrees that a fee at Initial Review MAQ or subsequent SBIC applicant result, SBA estimates that less than half is appropriate; this final rule includes a materials, performs due diligence, of SBIC applicants pay the licensing fee, $10,000 fee at Initial Review (‘‘Initial analyzes the management team’s even though SBA expends resources on Licensing Fee’’) beginning on the performance, interviews those all applicants. effective date of this rule. The amount management teams invited for an in- As part of the proposed rule, SBA of the licensing fee due at Final person interview, and ultimately asked for comments as to whether an determines whether to issue a formal applicant should pay a licensing fee Licensing (‘‘Final Licensing Fee’’) in invitation (‘‘Green Light Letter’’) to the prior to submitting its complete license this final rule has been reduced from the applicant to proceed to the final application, since SBA expends amount for such fee in the proposed licensing phase of the process. Once an significant resources prior to that time. rule by a commensurate decrease of applicant receives a Green Light Letter, SBA received one comment that $10,000. Accordingly, by October 1, the applicant typically has up to 18 supported a fee of up to $10,000 at the 2020, the combined licensing fees for a months to raise the requisite private first phase, Initial Review, with a single applicant will total $45,000, capital. During this timeframe, SBA commensurate decrease in the licensing which is the total amount of licensing keeps in touch with the applicant, fee at the second phase, Final Licensing. fees proposed by SBA in the proposed conducts SBIC training classes, and The commenter also suggested that SBA rule. The amount of the Final Licensing provides guidance as needed. The clarify its licensing standards, since half Fee is the amount due in effect on the applicant pays the licensing fee only at of all applicants that apply to the date when SBA accepts an applicant’s the final licensing phase (‘‘Final program do not receive a Green Light license application. Due to the timing of Licensing’’). Final Licensing occurs at Letter. SBA recommends that applicants this final rule, SBA removed the the time SBA accepts an applicant’s use the pre-screening process described proposed FY 2017 licensing fee. Table 3, complete license application (consisting on its Web site at www.sba.gov/sbic/ SBIC Initial and Final Licensing Fees, of an updated SBA Form 2181 and applying-be-sbic/pre-screening-process, below, identifies the Initial Licensing complete SBA Forms 2182 and 2183), which will remain free of charge after Fee and Final Licensing Fees in this which application is submitted after this final rule is published. This process final rule for each fiscal year.
TABLE 3—SBIC INITIAL AND FINAL LICENSING FEES
Initial Final Time licensing fee licensing fee
December 13, 2017–September 30, 2018 ...... $10,000 $20,000 October 1, 2018–September 30, 2019 ...... 10,000 25,000 October 1, 2019–September 30, 2020 ...... 10,000 30,000 October 1, 2020–September 30, 2021 ...... 10,000 35,000
Beginning on October 1, 2021, SBA will modifies the language in proposed $20,000 in FY 2017 and increase by increase the Initial Licensing Fee and § 107.410 to reflect the combined $2,500 each October through October 1, Final Licensing Fee using the Inflation Licensing Fee (Initial Licensing Fee plus 2020. The Maximum Base Fee for Adjustment and, prior to the date of the the Final Licensing Fee) as defined in Leveraged SBICs would increase to increase, will publish the amount in a the final § 107.300. $20,000 in FY 2017 and then by $6,000 Notice in the Federal Register. each October through October 1, 2020. D. Examination Fees Beginning on October 1, 2021, the Section 107.410—Changes in Control of Section 107.692(b)—Base Fee Minimum and Maximum Base Fee (for Licensee Current § 107.692(b) identifies a base both Leveraged and Non-leveraged SBA treats a change in control of a examination fee calculated as a SBICs) would increase using the Licensee as a licensing action since SBA percentage of an SBIC’s total assets at Inflation Adjustment. must perform similar functions and cost. As set forth in current § 107.692(b), For the purposes of calculating the processes to those in SBA’s licensing the percentage decreases as the assets examination fee, the proposed rule processes. Current regulations require increase, with the maximum base defined Non-leveraged SBICs as SBICs SBICs seeking a change in control to pay examination fee set at $14,000 for SBICs that have no outstanding SBA- a $10,000 fee, similar to the licensing with total assets greater than $60 guaranteed leverage or leverage fee. Since the procedures and costs are million. commitments and, in the case of SBICs similar to those in the licensing process, SBA proposed to modify § 107.692(b), that have issued leverage in the form of the proposed regulations changed the to replace the base fee calculation with Participating Securities, hold no current fee to be equal to the licensing the following formula: Base Fee = Earmarked Assets. An SBIC that satisfies fee identified in § 107.300. SBA Minimum Base Fee + 0.024% of assets these requirements must also certify to received no comments on this section. at cost, but not to exceed the Maximum SBA that it will not seek new SBA As noted above, this final rule does not Base Fee. The Minimum Base Fee leverage in the future. change the total amount of the licensing would increase to $5,000 in FY 2017 SBA received one comment fee in the proposed rule, but requires and increase each October by $1,000 supporting SBA’s proposal to tie the two payments rather than one: the through October 1, 2020. As proposed, examination fee to assets, noting that a Initial Licensing Fee and the Final the Maximum Base Fee for Non- fee not tied to assets would have been Licensing Fee. The final § 107.410 leveraged SBICs would increase to burdensome for smaller funds.
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SBA received one comment that the million in assets used leverage. SBA accommodations are necessary to enable increase is excessive, noting that while applies a higher level of scrutiny in SBICs to finance certain small there is an increase in the number of examining leveraged SBICs than non- businesses, these transactions require SBICs to be examined, there was no leveraged SBICs in exams, since SBA SBA to use more resources to monitor evidence provided that the cost of bears credit risk with respect to and examine them. examining an individual SBIC has leveraged SBICs. In addition, larger SBA believes the examination base fee doubled. As discussed previously, over leveraged SBICs often use complex is reasonable and consistent with the half of the increase in examination transaction structures which are more cost of other auditing services and is expenses since 1999 is due to inflation, time-consuming to examine. For finalizing § 107.692(b) as proposed with with most of the remainder due to the example, the percentage of SBIC the exception of one timing-related addition of subscription services, financings made through passive change. Due to the timing of this final technology improvements, and costs businesses (a type of financing that is rule, SBA is removing the FY 2017 fee associated with more experienced generally prohibited, but with permitted increase identified in the proposed rule analysts necessary to oversee SBA’s exceptions for passive businesses that and will begin with the FY 2018 fee, increased capital at risk (SBA leverage pass through proceeds to eligible active after the effective date of this rule. The and commitments), particularly in larger small businesses) increased from 3% in final § 107.692(b) replaces the base fee leveraged SBICs with over $60 million 1996 to over 14% over the past few calculation with the following formula: in assets. In December 1996, only 6 of years. This is partially due to the Base Fee = Minimum Base Fee + 0.024% the 28 SBICs with over $60 million in expansion of SBIC passive business of assets at cost, but not to exceed the assets used leverage and only 1 of the rules on December 23, 2014 (78 FR Maximum Base Fee. Both the Minimum 12 SBICs with over $120 million in 77377), which revised 13 CFR Base Fee and the Maximum Base Fee assets used leverage. As of December 31, 107.720(b)(2) to allow SBICs to invest in change each year as shown on Table 4, 2016, 122 of the 129 SBICs with over up to two levels of passive businesses Minimum and Maximum Base Fees, and $60 million in assets used leverage and under certain circumstances. Although are adjusted for inflation each year 72 of the 74 SBICs with over $120 SBA understands that these types of beginning October 1, 2021:
TABLE 4—MINIMUM AND MAXIMUM BASE FEES
Maximum base Maximum base Minimum base fee for fee for Time period (based on the examination start date) fee non-leveraged leveraged SBICs SBICs
December 13, 2017 to September 30, 2018 ...... $6,000 $22,500 $26,000 October 1, 2018 to September 30, 2019 ...... 7,000 25,000 32,000 October 1, 2019 to September 30, 2020 ...... 8,000 27,500 38,000 October 1, 2020 to September 30, 2021 ...... 9,000 30,000 44,000
Section 107.692(c)—Adjustments to • Add Low and Moderate Income § 107.692(c)(4) also retained the 10% Base Fee and (d) Fee Discounts and (LMI) Investing Discount: SBICs would addition charged to SBICs that maintain Additions Table receive a discount of 1% of the Base Fee records located in multiple locations. for every $10 million in LMI • Add Unresolved Finding Addition: Current § 107.692(c) provides for the Investments (in dollars at cost) financed To encourage SBICs to resolve findings following adjustments to the base since the Licensee’s last examination up in a timely manner, § 107.692(c)(5) SBA examination fee calculated under to a maximum 10% of the Base Fee. LMI proposed an additional fee equal to 5% § 107.692(b): 15% discount for no prior Investments are defined in § 107.50. of the Base Fee for every 30 calendar violations; 10% discount for • Remove Fully-responsive Discount; days or portion thereof that any responsiveness; 5% addition if SBIC is Add Non-Responsiveness Addition: examination finding that remains structured as a partnership or limited During development of the proposed unresolved after a 90 calendar day cure liability company; 10% addition if the rule, SBA found that most SBICs period (beginning on the date that SBA SBIC was licensed with the intent of regularly received the 10% discount notifies the SBIC that corrective action issuing Participating Securities; 10% available under § 107.692(c) for being must be taken), unless SBA ultimately addition if SBIC records are maintained ‘‘fully responsive to the letter of resolves the finding in the SBIC’s favor. at multiple locations; and 10% addition notification of examination.’’ SBA • Remove Additions for Partnership if the SBIC is licensed as an Early Stage therefore took into account the cost and LLC: Since almost all SBICs are SBIC. These adjustments were efficiencies resulting from organized as partnerships and LLCs, the summarized in tabular form in responsiveness when formulating the proposed rule removed these additional § 107.692(d). revised Base Fees in proposed fees from § 107.692(c) and incorporated SBA proposed to revise § 107.692(c) § 107.692(b). To compensate SBA for the the cost into the Base Fee. as follows: additional time required to examine the • Remove Additions for Participating • Retain No Violation Discount: SBA minority of SBICs that are not Securities Licensees and Early Stage proposed to retain the no violation responsive, proposed § 107.692(c)(3) SBICs: SBA proposed to remove the fee discount, which gives a 15% discount included an addition of 15% of the Base additions for Participating Securities on the Base Fee to SBICs that have no Fee for any SBIC that is ‘‘not fully Licensees and Early Stage SBICs, both of outstanding regulatory violations at the responsive to the letter of notification of which SBA no longer licenses. time of the examination start date and examination.’’ SBA received one comment that had no violations as a result of the most • Retain Records/Files at Multiple supported the removal of additions for recent prior examination. Location Addition: Proposed early stage, participating securities, and
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partnership/LLC; this final rule adopts questions from SBICs concerning less be necessary to apply the non- these proposed changes to § 107.692(c). than approximately 3% of its responsive addition in less than 3% of SBA received one comment that examination invoices. Each of the cases. For the reasons discussed above opposed the LMI discount, stating that adjustments SBA received comments on regarding SBA’s desire for a more discounts should not be used for is addressed in further detail below: uniform examination fee consisting of political or social goals. SBA proposed • No Violation Discount: SBA an examination base fee that reflects this discount partly in response to a received one comment that supported a SBA’s average cost to examine an SBIC comment submitted by the same uniform examination fee, with no with adjustments which increase that commenter on a different rule proposed discounts and no additional fees, except cost, the final rule includes the non- by SBA, the Impact SBIC Rule (81 FR in egregious cases. SBA agrees, in part, responsive addition. Since 5666), which comment stated, with this comment, and believes that a uncooperative SBICs increase SBA’s ‘‘facilitating investment dollars in LMI more uniform examination fee is costs, this final rule adopts the non- areas is consistent with the core statute desirable. Accordingly, this final rule responsive addition of 15% as and the Congressional mandate for the seeks to avoid any single discount or proposed, but with the clarification that SBIC program’’ and suggested that the addition being applied to a majority of SBA will provide a written warning LMI discount might be helpful. SBA SBICs. Although the proposed rule prior to assessment. agrees that LMI investments are proposed to retain the no violation • Records/Files at Multiple Location consistent with the SBIC program discount in current SBA regulations, Addition: SBA received one comment mission. Nonetheless, since the public since over 70% of SBICs examined in objecting to this addition, which is opposed this discount in the context of FY 2016 received the no violation currently in SBA regulations and which this rule, and LMI investments do not discount, SBA believes it is appropriate SBA proposed to retain. SBA notes that have a meaningful impact on the not to retain this discount. Further, and there is no risk of arbitrary application amount of time and resources required consistent with the desire for a more of this addition, since SBIC records are by SBA in connection with an uniform examination fee, the maintained either in a single or multiple examination, this final rule § 107.692(c) examination base fee identified in this locations. Further, in FY 2016, less than does not include this discount in final rule reflects SBA’s average cost to 2% of SBICs received this addition. This § 107.692(c). examine an SBIC, and examinations final rule maintains this addition in SBA received several comments on resulting in violations require SBA to § 107.692(c) since traveling to multiple the proposed adjustments to the spend time and resources to identify locations increases SBA’s time and examination base fee in the proposed and address those violations. If SBA costs. rule. One comment stated that SBA were to retain the no violation discount, • should not make adjustments to the the examination fee would not fully Unresolved Finding Addition: One examination fee based on arbitrary cover SBA’s cost of examining the SBIC. comment objected to this addition on decisions by examiners, including the Therefore, and in light of the comment the grounds that some resolutions, such no violation discount, non-responsive received supporting a more uniform as the sale of a portfolio company, may addition, records/files at multiple examination fee, SBA removed the no take more than 90 days to resolve. SBA locations addition, and the unresolved violation discount in this final rule. agrees with the comment that certain finding addition. Examination fee • Non-Responsive Addition: The resolutions may take longer than 90 adjustments are not determined comment objecting to this addition was days to resolve. Accordingly, the final arbitrarily, but rather, through a process particularly concerned that such an § 107.692(c) adopts this addition, since requiring exam manager review. An addition would be applied arbitrarily SBA spends a significant amount of examination may only apply an and without warning. SBA agrees with time trying to resolve unresolved adjustment to the fee if an SBA exam the comment that a written warning findings, but clarifies the language to manager agrees with the decision by the would be appropriate prior to assessing account for resolutions requiring longer examiner that an adjustment is this addition. As with all additions, this than 90 days to resolve. warranted. SBA exam managers review addition may only be applied with exam A summary of the resulting final examination fees prepared by each manager approval. Over 97% of SBICs § 107.692(c) examination fee additions examiner to ensure they are fairly and examined in FY 2016 received the (also presented in tabular form in final accurately assessed. Furthermore, SBICs discount for being responsive, and SBA § 107.692(d)) is summarized in Table 5, have the right to dispute any expects that if SBIC responsiveness Proposed Examination Fee Additions, examination fee invoice. SBA receives remains similar to FY 2016, it will only below.
TABLE 5—PROPOSED EXAMINATION FEE ADDITIONS
Examination fee additions Amount of addition ¥ % of base fee
(1) Non-responsive ...... 15%. (2) Records/Files at multiple locations ...... 10%. (3) Unresolved Findings ...... 5% of Base Fee for every 30 days or portion thereof beyond the 90 day cure period or such later date as SBA sets forth in the notice for each unresolved finding.
Just as with current § 107.692, the Assume that in March 2019, a leveraged relevant time period, the Base Fee final examination fee is calculated by SBIC has $125 million in assets at cost. would be equal to $32,000. If the SBIC taking the Base Fee determined under The Base Fee calculation ($7,000 + is non-responsive to the examiner’s § 107.692(b) and adding the adjustments .024% × $125 million) computes to requests and has records in multiple identified in § 107.692(c). The following $37,000. Since the Base Fee may not locations, the examination fee would be example demonstrates this calculation. exceed the Maximum Base Fee for the calculated as follows:
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TABLE 6—EXAMPLE MARCH 2019 EXAMINATION FEE CALCULATION
Amount Explanation
$32,000 ...... Base Fee determined per final § 107.692(b). + $ 4,800 ...... 15% addition for non-responsiveness per final § 107.692(c)(1). + $ 3,200 ...... 10% addition for records in multiple locations per final § 107.692(c)(2). $40,000 ...... Examination Fee.
Although the Base Fee has a provide additional transparency for the essential needs while remaining well minimum and maximum, the resulting SBIC community, a Regulatory Impact within the ability of qualified applicants examination fee does not have a Analysis is set forth below. to pay. In re-evaluating its technology minimum or maximum. Unresolved resources utilized in licensing in 1. Necessity of Regulation findings beyond the 90-day cure period response to a comment SBA received on could result in increasingly higher The Act authorizes SBA to collect the proposed rule, SBA now believes it examination fees. These additions are administrative fees to cover licensing will require technology and other intended to incentivize SBICs to be and examination costs. Currently, licensing resources similar to industry responsive and resolve any findings as licensing fees cover less than a quarter peers. Therefore, SBA’s licensing costs, quickly as possible. of SBA’s direct licensing costs and excluding overhead, are expected to examination fees cover less than half of increase from approximately $2 million Section 107.692(e)—Delay Fee direct examination costs. It is critical in FY 2016 to approximately $3 million Current § 107.692(e) states that SBA that SBA increase fees in order to cover by FY 2021. SBA is concerned that this may assess an additional fee of $500 per a larger portion of its licensing and final rule will only offset half of SBA’s day if SBA determines the examination examination expenses as contemplated licensing costs, excluding overhead, by is delayed due to the SBIC’s lack of by Congress. In addition, SBA will use FY 2021. SBA is considering proposing cooperation or the condition of its the funds made available as a result of a new rule after this final rule to further records. the rule to: (1) Improve technology for offset its costs. SBA proposed to amend § 107.692(e) both licensing and examinations; (2) SBA also considered implementing a to increase the current $500 per day improve examiner training; (3) pay for larger increase immediately in order to delay fee to $700 per day, to be adjusted necessary information subscription offset costs more quickly. For the time annually using the Inflation services; and (4) provide contractor being, SBA is opting to pursue the Adjustment, beginning on October 1, resources to support licensing and gradual increase identified in the 2021, to coincide with the date on examination activities. proposed rule to allow potential which the other fee inflation applicants time to adjust to these adjustments are computed. SBA 2. Alternative Approaches to the Regulation increases. However, in order to obtain received one comment objecting to the technology similar to private sector fee, asserting that it could be assessed A. Licensing Fees peers more quickly, SBA may consider arbitrarily in an examiner’s discretion. SBA considered several alternatives a future rule to accelerate this phased in SBA does not assess this fee arbitrarily, regarding licensing fees. SBA first schedule. and any assessment requires the process considered indexing the licensing fees B. Examination Fees set forth in the SBIC Examinations for inflation from 1996 (the year in Guidelines Standard Operating which SBA most recently raised SBA considered several alternatives to Procedure (10 09, October 28, 2013, Ch. licensing fees) to 2017. This alternative the examination fees in this final 4, § 2(e)), which provides that only the did not produce sufficient fees to offset regulation. SBA considered indexing the Associate Administrator for Investment SBA licensing costs and produced lower fees in current § 107.692(b) to reflect and Innovation may assess this delay fee licensing fees than those in this final inflation from 1997 to 2017. This after consulting with the Director of rule. The increase in SBA’s licensing alternative did not produce sufficient SBIC Examinations. SBA did not assess costs has been driven not only by fees to offset SBA’s examinations costs. this delay fee for any of the SBICs inflation since 1996, but also by the real In assessing the reasons for this, SBA examined in FY 2016. Delays can increase in SBA’s capital at risk (SBA analyzed the SBIC portfolios from both significantly increase SBA examination guaranteed leverage and commitments) periods and determined that the SBIC costs, therefore, SBA maintained this and the increased complexity of SBIC portfolio in 1997 was significantly delay fee in cases involving delays due applicant organizational documents. different than today. In 1997, most of to a lack of cooperation on the part of Therefore, SBA rejected the option of the SBICs with the highest total assets the SBIC or the poor condition of the adjusting the current fees only for were bank-owned SBICs that did not SBIC’s records. This final rule adopts inflation. issue SBA guaranteed debentures, and proposed § 107.692(e) without change. Given its technology and processing therefore required less time and Compliance With Executive Orders time concerns, SBA considered higher resources for SBA to examine. Today, 12866, 12988, 13132 and 13771, the licensing fees than those proposed and most of the highest-asset SBICs have Paperwork Reduction Act (44 U.S.C. Ch. finalized in this rule, in order to obtain significant amounts of SBA leverage. 35) and the Regulatory Flexibility Act (5 the same technology and resources Therefore, merely indexing the existing U.S.C. 601–612) utilized by industry peers, and fees would not appropriately reflect the contractor support to reduce times in costs associated with examinations. Executive Order 12866 the licensing process. SBA did not SBA also considered smaller The Office of Management and Budget attempt to fully cover its licensing costs examination fee increases that were has determined that this rule is not a in the proposed rule; at that time, SBA sufficient only to cover current costs ‘‘significant’’ regulatory action under stated that it believed the proposed fee and did not provide additional money Executive Order 12866. However, to increases would be sufficient to meet needed to address technology upgrades,
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training, or contractor support. SBA period would allow SBICs time to of this Final Rule. SBA estimates that by rejected this alternative for three budget and adjust to the higher fees. As October 2020, the average non-leveraged reasons. First, the OIG indicated the stated above, SBA is now concerned examination fee will increase by $7,000 need for improved technology and that the gradual approach will not allow and the average examination fee for training for examiners and suggested SBA to obtain critical resources in a leveraged SBICs will increase by that SBA increase its fees to cover these timely manner, and is considering $18,000 based on FY 2014–2016 costs. SBA agrees that such resources proposing a new rule to accelerate and examinations data. Thereafter, SBICs’ would improve the examination further increase the fee increase. costs will increase further through the function. Second, SBA believes the annual increases to reflect inflation 3. Potential Benefits and Costs examination fees in the proposed rule adjustments. are less than fees charged for similar SBA anticipates this final rule may Executive Order 13563 activities such as financial audits. SBA benefit taxpayers by covering a larger calculated the median private sector portion of SBIC program administrative A description of the need for this financial audit fee paid by SBICs costs through the collection of an regulatory action and benefits and costs examined in FY 2016 to be $53,000; this additional estimated $5 million to $6 associated with this action is included rule would result in an average FY 2021 million per year by October 2020. As above in the Regulatory Impact Analysis Examination Fee for those SBICs of less noted previously, these increased fees under Executive Order 12866. than half of that amount: approximately will (1) improve SBIC program In developing this rule, SBA talked only $24,000. Third, while SBA’s technology for both licensing and with fund of funds managers, auditors, outstanding leverage in its operating examinations, (2) improve examiner and contractors to determine whether portfolio has more than quadrupled training, (3) pay for necessary the fees in this final rule were from $2.2 billion at the end of information subscription services, (4) reasonable and, based in part on those September 30, 1999 to $10.7 billion as provide contractor resources to support discussions, SBA believes the fees in of March 31, 2017, the number of licensing and examination activities, this final rule are reasonable. In personnel in SBIC Examinations has and (5) cover a higher portion of reviewing organizational costs for SBIC declined by almost a third. In order to existing costs of licensing and applicants, including legal and other continue to monitor the SBIC program at examination activities. Collections are professional costs, SBIC applicants often the same level as in previous years, SBA expected to increase annually each year incur organizational costs amounting to intends to hire contractors with beginning in October 2021 based on the $500,000 or more. The increased specialized skills to support this CPI–U Inflation Adjustment. licensing fee represents a small function. SBICs should also benefit from the percentage of the total organizational SBA also considered a flat improved technology SBA expects to costs typically incurred by SBIC examination fee applicable to all SBICs acquire with the additional funds made applicants. SBA also compared Federal regardless of the cost of assets they hold. available as a result of this final rule. bank examiner fees and SBIC auditor SBA believes its examination activities This final rule will increase licensing fees (based on the SBIC annual are similar to financial auditor or bank costs for applicants and examination Financial Reporting Form 468s examiner activities, which typically costs for SBICs. Beginning on the submitted in 2015) with SBIC charge fees, based on asset cost, and effective date, the final rule will examination fees in this final rule. SBA therefore rejected this alternative. SBA increase licensing costs by $10,000 for believes the final licensing and also received a comment to the an applicant applying for Initial Review examination fees are reasonable in proposed rule that expressed concerns and by $5,000 for an applicant comparison to the market. about adverse impact on smaller funds submitting a complete license The table below provides the capital if the examination fee were not based on application at Final Licensing. The and typical SBIC expenses for the assets. Final Licensing fee will increase by average fund size of an SBIC licensed in SBA considered increasing the fees $5,000 each fiscal year, so by October FY 2016. As shown, SBIC licensing and more quickly to cover most of its 2020, the fee at Final Licensing will examination fees represent a small estimated costs, but believed that a increase by an additional $15,000 from percentage of the SBIC’s total capital gradual increase over a multi-year the first increase after the effective date and its expenses.
TABLE 7—SBA LICENSING AND EXAMINATION FEES IN COMPARISON TO CAPITAL AND TYPICAL EXPENSES FOR SBIC OF AVERAGE FUND SIZE LICENSED IN FY 2016
Leveraged Non-leveraged Description SBIC SBIC
Total Capital ...... $157,500,000 $73,750,000 Private Investor Capital ...... 52,500,000 73,750,000 SBA-Guaranteed Leverage ...... 105,000,000 0 Typical Organizational Costs Organizational Costs in FY 2016 ...... 500,000 500,000 SBA Licensing Fee in FY 2021 ...... 45,000 45,000 Typical Annual SBIC Operating Expenses Management Fee (2%) ...... 3,150,000 1,475,000 Other Expenses (Excluding SBA Leverage Interest, Leverage Fees, & Examination Fees) ...... 500,000 250,000 SBA Examination Fee in FY 2021 (Assumes asset cost equal to total capital. Non-leveraged SBICs are typically only examined every 18 months.) ...... 44,000 26,700
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Executive Order 12988 As noted above, the final § 107.300 PART 107—SMALL BUSINESS This rule meets applicable standards will increase licensing costs by $10,000 INVESTMENT COMPANIES for all applicants that submit an set forth in section 3(a) and 3(b)(2) of ■ Executive Order 12988, Civil Justice application for Initial Review after the 1. The authority citation for part 107 Reform, to minimize litigation, effective date of the rule, and by an continues to read as follows: eliminate ambiguity, and reduce additional $20,000 by October 1, 2020, Authority: 15 U.S.C. 681, 683, 687(c), burden. The rule will not have for all applicants that submit a license 687b, 687d, 687g, 687m. retroactive or presumptive effect. application for Final Review. The ■ 2. Amend § 107.50 by adding a combined total increase of $30,000 Executive Order 13132 definition of ‘‘Inflation Adjustment’’ in represents less than 0.05% of the alphabetical order to read as follows: For the purpose of Executive Order average applicant’s Regulatory Capital 13132, SBA has determined that this based on newly licensed SBICs between § 107.50 Definition of terms. rule will not have substantial, direct October 1, 2014, and September 30, * * * * * effects on the States, on the relationship 2016. Many applicants have Inflation Adjustment is the between the national government and organizational costs totaling around methodology used to increase SBIC the States, or on the distribution of $500,000, and some have far in excess administrative fees using the Consumer power and responsibilities among the of that amount. The combined FY 2021 Price Index for Urban Consumers (CPI– various levels of government. Therefore, initial and final licensing fee of $45,000 U), calculated by the U.S. Bureau of for the purpose of Executive Order would represent a small fraction of Labor and Statistics (BLS), using the 13132, Federalism, SBA has determined those costs. U.S. city average for all items, not that this final rule has no federalism SBA estimates that § 107.692 in this seasonally adjusted, with the base implications warranting the preparation final rule will eventually increase the period of 1982 ¥ 84 = 100. To calculate of a federalism assessment. average non-leveraged examination fee the Inflation Adjustment, each year, Executive Order 13771 by $7,000, representing less than 0.02% SBA will divide the CPI–U from the of the average non-leveraged SBIC’s most recent June by the CPI–U from This rule is not an E.O. 13771 Regulatory Capital, and the average June of the preceding year. If the result regulatory action because this rule is not leveraged SBIC examination fee by is greater than 1, SBA will increase the significant under E.O. 12866. $18,000, representing 0.02% of the relevant fees as follows: Paperwork Reduction Act, 44 U.S.C. Ch. average total capital under management (1) Multiply the result by the current 35 (Regulatory Capital and outstanding fee; and SBA guaranteed leverage). As a point of For purposes of the Paperwork (2) Round to the nearest $100. comparison, most SBIC managers charge Reduction Act, 44 U.S.C. Ch. 35, SBA * * * * * management fees of approximately 2% has determined that this rule will not ■ 3. Revise § 107.300 to read as follows: of capital under management. impose any new reporting or recordkeeping requirements. (Management fees, like the examination § 107.300 License application form and fees, are paid by the SBIC.) For a fee. Regulatory Flexibility Act, 5 U.S.C. 601– leveraged SBIC with $50 million in SBA evaluates license applicants in 612 Regulatory Capital and using 2 tiers of two review phases (initial review and The Regulatory Flexibility Act (RFA), leverage charging a 2% management fee, final licensing), as follows: 5 U.S.C. 601, requires administrative the management fee would equal $3 (a) Initial review. Except as provided agencies to consider the effect of their million a year. If the leveraged SBIC had in this paragraph, SBIC applicants must actions on small entities, small non- assets at cost of $150 million, and did submit a MAQ and the Initial Licensing profit businesses, and small local not incur any exam fee additions, the Fee. MAQ means the Management governments. Pursuant to the RFA, exam fee in FY 2021 would amount to Assessment Questionnaire in the form when an agency issues a final rule, the $44,000, representing less than 0.03% of approved by SBA and available on agency must prepare a Final Regulatory the SBIC’s total capital. The SBA’s Web site at www.sba.gov/sbic. Flexibility Act (FRFA) analysis, which examination fee would be a very small Initial Licensing Fee means a non- describes whether the impact of the rule percentage of the SBIC’s expenses. refundable fee of $10,000. An applicant will have a significant economic impact SBA believes that most applicants under Common Control with one or on a substantial number of small with sufficient private equity experience more Licensees must submit a written entities. However, § 605 of the RFA and capital raising ability will not be request to SBA, and the Initial Licensing allows an agency to certify a rule, in lieu discouraged from applying to the Fee, to be considered for a license and of preparing a regulatory flexibility program based on the administrative fee is exempt from the requirement in this analysis, if the rulemaking is not increases identified in this final rule. paragraph to submit a MAQ unless expected to have a significant economic SBA asserts that the economic impact of otherwise determined by SBA in SBA’s impact on a substantial number of small the rule is minimal. Accordingly, the discretion. entities. This final rule will affect all Administrator of the SBA certifies that (b) Final licensing. (1) An applicant applicants that submit applications this final rule will not have a significant may proceed to the final licensing phase (which averaged 50 per year for FYs economic impact on a substantial only if notified in writing by SBA that 2014 to 2016), and all operating SBICs number of small entities. it may do so. Following receipt of such (316 as of May 22, 2017). SBA estimates List of Subjects in 13 CFR Part 107 notice, in order to proceed to the final that approximately 98% of these SBICs licensing phase, the applicant must are small entities. Therefore, this rule Examination fees, Investment submit a complete license application, will have an impact on a substantial companies, Loan programs—business, in the form approved by SBA and number of small entities. However, SBA Licensing fees, Small businesses. available on SBA’s Web site at has determined that the rule will not For the reasons stated in the www.sba.gov/sbic, within the timeframe have a significant economic impact on preamble, SBA amends 13 CFR part 107 identified by SBA; and the Final small entities affected by the rule. as follows: Licensing Fee. The Final Licensing Fee
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means a non-refundable fee (determined application) adjusted annually as as of the date SBA accepts the follows:
Final licensing Time period fee
December 13, 2017 to September 30, 2018 ...... $20,000 October 1, 2018 to September 30, 2019 ...... 25,000 October 1, 2019 to September 30, 2020 ...... 30,000 October 1, 2020 to September 30, 2021 ...... 35,000
(2) Beginning on October 1, 2021, (b) Fee. A processing fee equal to the (b) Base Fee. (1) The Base Fee will be SBA will annually adjust both the Initial combined Licensing Fee (Initial assessed based on your total assets (at Licensing Fee and Final Licensing Fee Licensing Fee plus the Final Licensing cost) as of the date of your latest using the Inflation Adjustment and will Fee then in effect) defined in § 107.300 certified financial statement, including publish a Notice prior to such must accompany any application for if requested by SBA in connection with adjustment in the Federal Register approval of one or more transactions or the examination, a more recently identifying the amount of the fee. events that will result in a transfer of submitted interim statement. For ■ 4. In § 107.410, revise paragraph (b) to Control. purposes of this section, Base Fee means read as follows: the Minimum Base Fee plus 0.024% of ■ 5. In § 107.692, revise paragraphs (b) assets at cost, rounded to the nearest § 107.410 Changes in Control of Licensee through (e) to read as follows: (through change in ownership or $100, not to exceed the Maximum Base otherwise). § 107.692 Examination fees. Fee. The Minimum and Maximum Base * * * * * * * * * * Fees are adjusted annually as follows:
Maximum Maximum Time period Minimum base fee for base fee for (Based on the examination start date) base fee non-leveraged leveraged SBICs SBICs
December 13, 2017 to September 30, 2018 ...... $6,000 $22,500 $26,000 October 1, 2018 to September 30, 2019 ...... 7,000 25,000 32,000 October 1, 2019 to September 30, 2020 ...... 8,000 27,500 38,000 October 1, 2020 to September 30, 2021 ...... 9,000 30,000 44,000
(2) In the table in paragraph (b)(1) of section, will be increased based on the additional charge equal to 10% of your this section, a Non-leveraged SBIC following criteria: Base Fee; and means any SBIC that, as of the date of (1) If you were not fully responsive to (3) For any regulatory violation that the examination, has no outstanding the letter of notification of examination remains unresolved 90 days from the Leverage or Leverage commitment, has (that is, you did not provide all date SBA notified you that you must no Earmarked Assets, and certifies to requested documents and information take corrective action (as established by SBA that it will not seek Leverage in the within the time period stipulated in the the date of the notification letter) or future. Beginning on October 1, 2021, notification letter in a complete and such later date as SBA sets forth in the SBA will annually adjust the Minimum accurate manner, or you did not prepare notice, you will pay an additional Base Fee and Maximum Base Fees using or did not have available all information charge equal to 5% of the Base Fee for the Inflation Adjustment and will requested by the examiner for on-site every 30 days or portion thereof that the publish a Notice prior to such review) after a written warning by the violation remains unresolved after the adjustment in the Federal Register identifying the amount of the fees. SBA, you will pay an additional charge cure period, unless SBA resolves the (c) Adjustments to Base Fee. In order equal to 15% of your Base Fee; finding in your favor. to determine the amount of your (2) If you maintain your records/files (d) Fee additions table. The following examination fee, your Base Fee, as in multiple locations (as permitted table summarizes the additions noted in determined in paragraph (b) of this under § 107.600(b)), you will pay an paragraph (c) of this section:
Examination fee additions Amount of addition ¥ % of base fee
Non-responsive ...... 15%. Records/Files at multiple locations ...... 10%. Unresolved Findings ...... 5% of Base Fee for every 30 days or portion thereof beyond the 90 day cure period or such later date as SBA sets forth in the notice for each unresolved finding.
(e) Delay fee. If, in the judgment of fee of $700 per day. Beginning on Register identifying the amount of the SBA, the time required to complete your October 1, 2021, SBA will annually fee. examination is delayed due to your lack adjust this fee using the Inflation of cooperation or the condition of your Adjustment and will publish a Notice records, SBA may assess an additional prior to such adjustment in the Federal
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Dated: November 6, 2017. Background Before beginning the section-by- Linda E. McMahon, The HIRE Vets Act was enacted on section analysis, however, VETS Administrator. May 5, 2017, as Division O of the acknowledges and responds to [FR Doc. 2017–24535 Filed 11–9–17; 8:45 am] Consolidated Appropriations Act, 2017, comments that did not correspond to specific sections of the rule. BILLING CODE 8025–01–P Public Law 115–31. The purpose of the Comments: Several commenters Act is to create a voluntary program for expressed general support for the HIRE recognizing efforts by employers to Vets Medallion Program and the DEPARTMENT OF LABOR recruit, employ, and retain veterans proposed rule. through a HIRE Vets Medallion Award. Response: VETS looks forward to Veterans’ Employment and Training The Act requires the Department to Service honoring employers who make it a issue regulations establishing the HIRE priority to invest in recruiting, Vets Medallion Program. 20 CFR Part 1011 employing, and retaining veterans. The In preparation for drafting a rule to HIRE Vets Medallion Award is based on [Docket No. VETS–2017–0001] implement the Act, VETS conducted transparent criteria and aims to honor three stakeholder sessions during the RIN 1293–AA21 all employers, from the smallest to the week of June 5, 2017. During these largest, who meet these standards. The stakeholder sessions, VETS obtained HIRE Vets Medallion Program example set by recipients of this award input from large, medium, and small will serve as models for other employers AGENCY: Veterans’ Employment and employers, veterans service committed to hiring and retaining Training Service (VETS), Labor. organizations, military service veterans. ACTION: Final rule. organizations, and other interested Comments: Conversely, several parties. commenters expressed skepticism as to SUMMARY: VETS published a proposed On August 18, 2017, VETS published the utility of the proposed program and rule implementing the Honoring a notice of proposed rulemaking whether the costs of the proposed Investments in Recruiting and (NPRM) to implement the HIRE Vets Act program outweighed the program’s Employing (HIRE) American Military (82 FR 39371). VETS invited public benefits. Veterans Act of 2017 (HIRE Vets Act or comment on the proposed regulations, Response: No one is required to apply Act). The HIRE Vets Act requires the and included questions about specific for a HIRE Vets Medallion Award. If the Department of Labor (DOL or issues. The comment period closed on costs for an employer exceed the Department) to establish by rule a HIRE September 18, 2017, and VETS has benefits, they need not apply. Vets Medallion Program (Medallion considered all timely comments Nevertheless, VETS is of the opinion Program) and annually solicit and received in response to the proposed that some employers will find that the accept voluntary information from regulations. benefits of the award exceed the costs of employers for consideration of VETS received 18 comments from a applying. Congress determined that the employers to receive a HIRE Vets wide variety of sources. Commenters HIRE Vets Medallion Program is a Medallion Award (the award). Under included: Veterans, employers, a constructive way for the Federal the Program, VETS will review national organization representing Government to recognize companies applications and notify recipients of service providers, an employer that have made significant efforts to hire their awards, and announce their names association, and members of the public. and retain veterans. The HIRE Vets at a time that coincides with Veterans While a few of the comments were Medallion Program will allow VETS to Day. This final rule sets out the criteria general comments related to the benefit further leverage its existing Veteran for the different categories and levels of of the program or to veterans issues, the Employment Outreach Program (VEOP) HIRE Vets Medallion Awards, the award majority of comments specifically that directly supports efforts to assist application process, and the award fees. addressed issues contained in VETS’ employers in recruiting and employing VETS invited written comments on the proposed rule. veterans, along with existing partnerships with agencies such as the proposed rule, and any specific issues Section-by-Section Summary of the Small Business Administration (SBA) related to the proposal, from members of Final Rule and Discussion of Comments the public. and State workforce agencies. This DATES: This rule is effective on January This preamble summarizes the final Program allows VETS to highlight and 12, 2018. rule, section by section, and evaluates model employer efforts that can assist and responds to the public comments employers nationwide to develop FOR FURTHER INFORMATION CONTACT: received. The subparts of the preamble Randall Smith, Veterans’ Employment veteran employment efforts further. generally follow the subparts of the final Comment: Finally, one commenter and Training Service, U.S. Department rule. Within each subpart of the questioned why the HIRE Vets of Labor, Room S–1325, 200 preamble, VETS addresses those public Medallion Program is not administered Constitution Avenue NW., Washington, comments related to regulatory sections by the U.S. Department of Veterans DC 20210, email: [email protected], within that subpart of the rule. If a Affairs. telephone: (202) 693–4700 or TTY (877) proposed regulatory section is not Response: Under 38 U.S.C. 889–5627 (these are not toll-free addressed in the discussion below, it is 4102A(a)(1), the Assistant Secretary of numbers). For press inquiries, contact because the public comments submitted Labor for VETS is responsible for all Joe Versen, Office of Public Affairs, U.S. in response to the NPRM did not DOL employment and training programs Department of Labor, 200 Constitution substantively address that specific that to the extent that they affect Avenue NW., Room S–1032, section and no changes have been made veterans. VETS’ mission is to prepare Washington, DC 20210, email: to the regulatory text. Further, VETS has America’s veterans, service members, [email protected], telephone: made a number of non-substantive and their spouses for rewarding careers, (202) 693–4696 (this is not a toll-free changes to improve the readability and provide them with employment number). conform the document stylistically that resources and expertise, protect their SUPPLEMENTARY INFORMATION: are not discussed in the analysis below. employment rights, and promote their
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employment opportunities. Consistent employers, while another recommended VETS becomes aware of facts that with that responsibility, Congress defining large employers as those with indicate information provided by an specifically assigned administration of 10,000 or more employees. employer may be incorrect, and the HIRE Vets Medallion Award to the Response: VETS retains the rule § 1011.600 requires the employer to Secretary of Labor (Secretary). VETS language as proposed because the retain the information supporting its supports workforce resources for employer category sizes are established application for 2 years. VETS retains the employers to develop a globally by statute in section 3(b) of the Act. language as proposed. competitive workforce and the public Consequently, VETS does not have the Comment: One commenter stated that workforce system is a valuable resource discretion to make this change. for some industries, retention numbers are proprietary information and asked to support human capital development Subpart B—Award Criteria of workers across the country. The how employers could ensure that system offers essential tools to Sections 1011.100 through 1011.120 information used for judging the award employers to help transform the enumerate the award criteria for the would not be released to the public or workforce to meet the changing various award categories and levels. their competitors. demands of the 21st-century economy, VETS received a few comments Response: VETS cannot ensure that and to become more competitive. suggesting additional criteria or information submitted for evaluating an requesting clarification on criteria. application will not be released to the Subpart A—Introduction to the VETS also received several comments public. Therefore, information Regulations for the HIRE Vets Act on the violation of labor law provision submitted by an applicant may become Sections 1011.000 through 1011.015 at § 1011.120. Because many of these available to the public. The HIRE Vets detail the program’s purpose, scope, comments apply across sections, this Medallion Program is a voluntary definitions, and award types. VETS preamble first addresses comments that program. In order to ensure received several comments on the touch on multiple sections, then reviewability, all applicants must definitions at § 1011.005 and on the addresses comments on § 1011.120, and provide the required information in employer size categories at § 1011.015. finally addresses comments suggesting order to qualify for an award. VETS new criteria. retains the language as proposed. Definition of Veteran Comment: One commenter stated that Comment: One commenter questioned Comments on Proposed Criteria the retained percentage should be the use of the definition of ‘‘veteran’’ at Comment: One commenter suggested compared to the number of actual hires 38 U.S.C. 101. The commenter that the same criteria should apply to all and that employers should present the expressed a desire for VETS to employers regardless of size. number of hires along with the number incorporate National Guard members Response: For the sake of simplicity, of veterans retained within a given mobilized under U.S.C. title 32 into the VETS retained consistency across timeframe. definition of ‘‘veteran’’ as it implements awards to the extent possible. However, Response: VETS agrees that the the statute into final regulatory text. to recognize that employers of different awards should include both hiring and Response: Section 8(c) of the Act sizes will likely have different retention and such criteria are included. states that the term ‘‘veteran’’ has the resources, VETS proposed that small Comment: A commenter requested meaning given such term under 38 employers need not satisfy as many that VETS merge the requirements that U.S.C. 101. Incorporating all criteria as medium employers and that employers establish internal mobilization under Title 32 would be medium employers need not satisfy as organizations (such as the veteran inconsistent with the meaning of section many criteria as large employers. VETS organization or resource group) with the 8(c) of the Act. Consequently, VETS concludes that the proposed language requirement that employers establish an declines to make this change. However, strikes the best balance between these assistance or training program. This as we stated in the NPRM, VETS two interests and retains the language as commenter also suggested that the recognizes that most employers proposed. percentage of veteran employees determine which employees are Comment: A commenter requested enrolled in the veteran organization or veterans according to the employee’s that VETS ensure that there is a resource group could be an additional self-identification. VETS does not meaningful retention requirement. The weighted criterion. expect employers to change these commenter also suggested companies Response: VETS retains the language practices in order to guarantee that that hire veterans in order to meet as proposed. Section 3(b)(1) of the Act every employee who self-identifies as a award requirements and subsequently establishes these criteria as separate veteran meets the definition of veteran lay off those veterans be made to return criteria intended to serve separate set out in the Act. VETS’ primary any award they receive. purposes. Veteran organizations or concern is that an employer applying for Response: VETS agrees that retention resource groups are support networks an award reports as accurately as it is is a very important issue for veteran for veteran employees while the reasonably able. VETS retains the employees. Consequently, every award ‘‘assistance or training program’’ focuses language as proposed. has a retention criterion. As to the on the provision of post-secondary commenter’s concern about employers education to veteran employees. Employer Size Categories hiring veterans and then laying them However, there can be overlap in how Comments: Two commenters off, these awards recognize actions the employer satisfies its criteria. For requested a change to the employer taken and VETS will not revoke an instance, a large employer’s human award size categories, expressing that it award if an employer legitimately resources professional might run the might be difficult for companies with qualified for the award in the previous employee veteran organization or more than 500 employees but fewer year. However, VETS can revoke an resource group. Similarly, the tuition than 10,000 employees to compete with award for the reasons described in assistance program for post-secondary those employers that have more than § 1011.230, including if the employer education might overlap with the 10,000 employees. One commenter falsely attested to its retention numbers. programs established to enhance the questioned if perhaps revenue would be Moreover, § 1011.225 allows VETS to leadership skills of veteran employees. a better standard by which to categorize review an application, if at any time As for the suggestion that the percentage
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of veteran employees enrolled in the the pay differential is only included as employer that does not take its veteran organization or resource group part of the platinum award criteria and obligations under the Uniformed be an additional criterion, VETS is only required for the large employer Services Employment and declines to make this change because it platinum award. Consequently, Reemployment Rights Act of 1994 would create an additional reporting employers could receive all awards (USERRA) and the Vietnam Era burden for employers. except the large employer platinum Veterans’ Readjustment Assistance Act Comment: One commenter stated, in award without satisfying this criterion. of 1974 (VEVRAA) seriously is regard to the dedicated human resources VETS concludes that inclusion of the undeserving of an award; limiting the professional criterion, that large provision of pay differential for as long covered laws to USERRA and VEVRAA; employers might have hiring, training, as the employee is on active duty is and retaining discretion to delay an and retention responsibilities spread consistent with the higher standard award if VETS has credible information across multiple departments. expected of platinum awardees. suggesting that a significant violation Response: Large employers can have Consequently, VETS retains the may have occurred. A commenter also veteran hiring, training, and retention language as proposed. stated that no additional disqualifying responsibilities spread across multiple Comment: One commenter requested events should be added to the list. departments and still meet the criterion an explicit list as to which programs Comment: One commenter stated that at § 1011.100(b)(7). Large employers constitute ‘‘assistance’’ or ‘‘training’’ while most of the regulation tracks the with more than 5,000 employees need to programs. Act, the Act contained no corresponding have at least one dedicated human Response: VETS retains the language section to the violation of labor law resources professional per the as proposed in order to retain flexibility provision proposed at § 1011.120. requirements of section 3(b)(1)(C)(iv) of for employers to provide integration Response: Section 3(b)(1)(E) of the Act the Act, but the definition of Dedicated assistance that best suits their grants VETS authority to establish Human Resources Professional in workforce. However, VETS agrees that a additional criteria for each level of § 1011.005 states that these duties can non-exhaustive list of examples of post- award. VETS used this authority to be split amongst multiple people so long secondary education programs that establish the criterion described in as the time spent supporting the hiring, would satisfy the tuition assistance § 1011.120. VETS chose to include this training, and retention of veteran program criterion would be useful for criterion because employers that have employees is the equivalent of one full- employers. Examples of post-secondary been proven to have violated, or have time professional. Additionally, large programs and courses for which explicitly admitted violating the rights employers that employ 5,000 or fewer employers may provide tuition of their veteran employees should not employees need not have a dedicated assistance include: receive an award from VETS for their human resources professional but may veteran employment practices. VETS instead satisfy this criterion by having at b Correspondence training retains the language as proposed. least one human resources professional b Cooperative training Comment: One commenter suggested whose regular work duties include b Entrepreneurship training that ‘‘technical or minor’’ violations of supporting the hiring, training, and b Flight training USERRA or VEVRAA should not be retention of veteran employees. The b Independent and distance learning disqualifying. The commenter asserted proposed language is consistent with b Undergraduate and graduate degrees that this provision in the proposed rule the Act and does not prohibit large b Licensing and certification was similar to provisions in the employers from having veteran hiring, reimbursement guidance implementing the now training, and retention responsibilities b Vocational/technical training and rescinded Executive Order 13673, and spread across multiple departments. non-college degree programs that the effect could be employers being VETS retains the language as proposed. b National testing reimbursement disqualified for the award for issues Comment: One commenter expressed b On-the-job training and unrelated to the recruitment, concern that the pay differential apprenticeships employment, and retention of veterans. criterion was too vague, as it did not b Tutorial assistance Response: The disqualification define the types of deployment to which Also, as the proposed rule explained, standard proposed in § 1011.120 is far the pay differential criterion applied. the assistance provided through an narrower than the one used in the The commenter also questioned the employer’s tuition assistance program implementation of now rescinded length of time an employer would need may take many forms, including Executive Order (E.O.) 13673. The E.O. to offer the pay differential in order to financial assistance, leave assistance, or covered numerous additional labor satisfy the criterion and whether small discounts on post-secondary education. statutes (instead of just the veteran and medium employers would be able VETS will continue to offer technical employment protections covered here) to afford the pay differential for more assistance on the types of activities and and would disqualify an employer for than a year. programs that satisfy the other violation determinations made by the Response: The definition of Active integration assistance criteria. agency before judicial enforcement Duty in the United States National proceedings began. Since fairness Comments on Veteran-Specific Labor Guard or Reserve at § 1011.005 defines requires that all applicants be subject to Violations Criterion at § 1011.120 the types of deployment to which the a clear and consistent standard, the final pay differential criterion applies by Section 1011.120 outlines the rule will retain the bright line standard reference to the definition of active duty circumstances that would disqualify or instead of adopting a flexible standard. in 10 U.S.C. 101(d)(1). Because this delay an employer from receiving a Additionally, VETS declines to revise definition is well-established and HIRE Vets Medallion Award for the regulatory text to distinguish sufficiently clear, VETS retains the violations incurred under labor laws between purportedly major and minor proposed language without change. protecting veterans as administered by, violations for the purposes of this rule. Additionally, VETS appreciates the or in conjunction with, VETS and the Comment: One commenter questioned commenter’s concern that the pay Office of Federal Contract Compliance whether one of the proposed differential applies for as long as the Programs (OFCCP). Commenters disqualifying events, a settlement employee is on active duty. However, supported: The premise that an agreement in which the employer
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admits a violation of either USERRA or appropriate ESDS, it has satisfied its and charitable services provided by VEVRAA, should be included given the obligation under the regulations, and employers to the veteran community. varying reasons that employers enter would not be disqualified from Response: Section 2(a) of the Act into settlement agreements. If VETS receiving an award as a result. See 41 states that the purpose of the Act is to were to keep this provision, the CFR 60–300.5(a)(2). Second, an recognize efforts by employers to commenter opined that it should not be ‘‘alleged’’ violation of VEVRAA’s recruit, employ, and retain veterans and expanded, so as to avoid creating a mandatory job listing requirement to provide community and charitable disincentive for settling allegations. would not alone trigger disqualification. services supporting the veteran Response: VETS retains the language As this final rule makes clear, only a community. VETS agrees that as proposed. The rule would only decision of an administrative law judge community and charitable services are disqualify employers with settlement that is not appealed and becomes the an integral part of supporting the agreements in which the employer final agency action, or a settlement veteran community. However, VETS specifically admits to violating USERRA agreement in which the employer declines to establish an additional or VEVRAA, two laws closely related to explicitly admits that it violated criterion related to community and veteran employment. If the employer VEVRAA, could result in charitable services because these has violated these laws and admits to disqualification. services are already integrated doing so in a settlement agreement, throughout the large employer criteria Suggested New Criteria VETS has concluded that this is as that serve as the basis for the small and serious as the judgment of a court or Comment: One commenter requested medium employer criteria. tribunal and, thus, considers it a that VETS create an alternative criterion Consequently, VETS retains the disqualifying event. Settlement to the veteran employee percentage language as proposed. agreements in which the employer does criterion that weighs the number of Comment: One commenter suggested not admit liability for violations of these veterans who are applying for an additional criterion that employers statutes would not disqualify an employment, potentially tracking use the workforce development system employer from consideration. progress for employers with nascent to list their job openings, either directly Comment: One commenter suggested veteran hiring programs. The with State job banks or through the that the regulation more explicitly commenter expressed concern that the National Labor Exchange (NLx). The reference the VEVRAA requirement that alternative veteran employee percentage commenter expressed concern that if covered Federal Government contractors criterion does not always correlate with such a criterion is not established, then and subcontractors follow mandatory the effort that employers put into a the high-quality jobs offered by job listing requirements. veterans hiring initiative, favoring Response: VETS retains the language employers applying for the award might employers with already established as proposed because the fact that VETS not reach the veterans, transitioning programs. has incorporated USERRA or VEVRAA service members, and spouses served by into the rule should serve to highlight Response: The number of veteran the Department. all USERRA and VEVRAA requirements applications, while an integral part of Response: NLx is recognized as a for covered employers. Additionally, it recruitment, does not necessarily equate workforce system tool that collects and is not appropriate to elevate this single to hiring or retention, the focus of the disseminates job postings, including aspect of the VEVRAA requirements Act. Therefore, in order to best reflect through State job banks. VETS when covered employers must comply the focus of the Act and to retain encourages employers to use State job with all requirements. simplicity, VETS retains the language as banks as a resource to help with the Comment: One commenter raised the proposed instead of adding an recruitment of veteran employees. specific concern that Federal contractors additional alternative criterion. Although VETS encourages the use of attempting to comply with the Comment: One commenter requested State job banks, it declines to add a mandatory job listing requirement set that a portion of the application allow related criterion in order to retain forth in the VEVRAA statute and employers to outline military/veteran- flexibility for employers in structuring regulations may nevertheless have friendly initiatives or awards that the how they satisfy the award criteria. violations alleged against them, which employers have received. Comment: One commenter also could result in their disqualification Response: The application form suggested an additional criterion from receiving an award. The contains an optional item that allows requiring engagement with the commenter expressed concern over an employers to describe efforts to support workforce development system or that, employer not being able to qualify for an the veteran and military community. at the very least, additional award because, although the employer However, this item is not a criterion for consideration be provided to provides job vacancies to a State or local recognition and will not factor into applications that reflect collaboration employment service as required by law, whether an employer receives an award. with the workforce development the employment service fails to post the It will instead be used to facilitate the system. The commenter stated that vacancies. sharing of good practices for veteran employers could use the workforce Response: This concern is misplaced. hiring and retention. The HIRE Vets development system to screen job First of all, the specific situation Medallion Program is a recognition applicants and facilitate participation in described by the commenter, in which program to honor employer career and hiring events, as well as for a contractor provides the required job commitment to, and investment in, help with many other activities. The vacancy information to the employment veteran recruiting and employment. commenter noted that these services service delivery system (ESDS) location Therefore, VETS declines to establish a might be particularly critical for small and the ESDS does not post it, does not criterion for the HIRE Vets Medallion employers who lack a human resources constitute a violation of VEVRAA. Per Program related to other military/ professional. The commenter also noted the relevant VEVRAA regulations, so veteran-friendly initiatives and awards. that employers can serve on State and long as the contractor provides the job Comment: A commenter requested Local Workforce Development Boards vacancy information ‘‘in any manner inclusion of an additional criterion where they can participate in the design and format permitted’’ by the more specifically targeting community and operation of services in their area.
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Response: The public workforce Response: VETS is responsible for the costs; tailor the regulation to impose the system includes a nationwide network application review and award least burden on society, consistent with of over 2,400 American Job Centers determination for the HIRE Vets achieving the regulatory objectives; and (AJCs), a network operated in Medallion Program. in choosing among alternative partnership by Local Workforce VETS also made a nonsubstantive regulatory approaches, select those Development Boards, State Workforce change to § 1011.230(a), clarifying that approaches that maximize net benefits. Agencies, and DOL. VETS will continue VETS can deny an award if an employer Executive Order 13563 recognizes that to work closely with Federal and State fails to satisfy all application some benefits are difficult to quantify partners to provide coordinated requirements. This is not a substantive and provides that, where appropriate information and services to job seekers change; this requirement was already and permitted by law, agencies may and employers while continually included in § 1011.010. However, VETS consider and discuss qualitative values facilitating and developing meaningful has added it to the language of that are difficult or impossible to employment and training opportunities § 1011.230 for additional clarity. quantify, including equity, human for transitioning service members, Subpart D—Fees and Caps dignity, fairness, and distributive veterans, and military families. impacts. VETERANS.GOV enables employers to Subpart D sets out the fees for the directly contact VETS’ VEOP to request HIRE Vets Program and the application Under Executive Order 12866, the assistance in hiring veterans. Although, caps that VETS can utilize. Office of Management and Budget as with the comment on including a Comment: One commenter requested (OMB) must determine whether a State job bank or NLx criterion, VETS clarity as to whether it is VETS’ regulatory action is significant and encourages employers to take advantage understanding that the fee authorized by therefore subject to the requirements of of the public workforce system, it section 5(b) of the Act can only be that Executive Order and to review by declines to add a related criterion in collected if a future appropriations OMB (58 FR 51735). Section 3(f) of order to retain flexibility for employers. action triggers the fee collection. Executive Order 12866 defines a Comment: One commenter suggested Response: Section 5(b) of the Act ‘‘significant regulatory action’’ as an adding a criterion for procedural grants VETS authority to collect fees action that is likely to result in a rule descriptions of a 6-month onboarding and states that VETS ‘‘shall establish the that: (1) Has an annual effect on the process for veteran employees. amount of the fee such that the amounts economy of $100 million or more, or Response: Although VETS agrees that collected as fees and deposited into the adversely affects in a material way a effective onboarding of veteran [HIRE Vets Medallion Award] Fund are sector of the economy, productivity, employees is important to the sufficient to cover the costs associated competition, jobs, the environment, establishment of a successful working with carrying out this division.’’ public health or safety, or State, local, environment for veteran employees, the Therefore, the Act grants VETS or Tribal governments or communities final rule retains the language as authority to collect fees and does not (also referred to as economically proposed because the various forms of require a future appropriations action to significant); (2) creates serious integration assistance covered by the trigger this authority. inconsistency or otherwise interferes proposed criteria already answer the Comment: One commenter expressed with an action taken or planned by purpose of this request. For example, concern about the accountability of the another agency; (3) materially alters the the veteran organization or resource award fund and asked what safeguards budgetary impacts of entitlement grants, group criterion requires that the would be in place to protect money in user fees, or loan programs, or the rights organization or resource group assist the fund. and obligations of recipients thereof; or ‘‘new veteran employees’’ (emphasis Response: Funds contained in the (4) raises novel legal or policy issues added). HIRE Vets Medallion Award Fund will arising out of legal mandates, the President’s priorities, or the principles Subpart C—Application Process be subject to the same protections and safeguards that are applied to all Federal set forth in Executive Order 12866. Id. Subpart C sets out the application Government funds. VETS has determined that this rule is process for the HIRE Vets Medallion Subpart E—Design and Display not an economically significant Award. VETS received two comments regulation—neither the costs nor the on subpart C. VETS received no comments on benefits exceed $100 million dollars in Comment: A commenter asked that subpart E. any given year. VETS has determined VETS reconsider § 1101.210 and that that this rule is not a ‘‘significant employers be allowed to win an award Subpart F—Requests for regulatory action’’ under section 3(f) of every year. Reconsideration Response: The requirement at Executive Order 12866. VETS analyzed VETS received no comments on costs and benefits of this rule using § 1011.210 is a requirement of the Act. subpart F. Section 2(d) of the Act states that ‘‘[a]n 2016 employment and wage data from employer who receives a HIRE Vets Subpart G—Record Retention the Bureau of Labor Statistics (BLS). The cost analysis uses a 10-year time Medallion Award for one calendar year VETS received no comments on horizon. The benefits analysis is is not eligible to receive a HIRE Vets subpart G. Medallion Award for the subsequent qualitative and appears at the end of Procedural Determinations calendar year.’’ Consequently, VETS this section. Since the benefits analysis is qualitative, there will be no analysis does not have discretion to make this Executive Orders 12866 and 13563: of net benefits (benefits minus costs). change. However, for purposes of Regulatory Planning and Review clarity, VETS has amended proposed VETS’ estimates of costs are presented Introduction § 1011.210 to reference section 2(d) of as follows: the HIRE Vets Act. Executive Order 13563 directs • Veteran employment and potential Comment: A commenter also asked agencies to propose or adopt a eligibility for the award—Estimates how VETS to clarify who will be reviewing regulation only upon a reasoned many employers may meet the applications for the medallion awards. determination that its benefits justify its application requirements of the award.
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• Unit costs—Estimates the unit costs to these comments in the remainder of 7 percent or more veteran employees, of complying with the application this section. while it may be more difficult in other requirements of the award. industries. • Participation rates—Estimates how Veteran Employment and Potential Eligibility for the Award Veteran employment levels at the 3- many eligible employers will potentially digit NAICS level (industry subsectors) choose to apply for the award. As of 2016 there were 20.9 million were mapped to BLS data from the • Government costs—Estimates the 1 veterans, making up 10 percent of the Current Employment Statistics survey to costs to the Government for processing civilian non-institutionalized derive veteran employment as a the applications and the costs to population over the age of 18. While the percentage of total employees by NAICS develop the system to support the total number of veterans varies over code. The results of this comparison are review and approval process. • time, there are between 240,000 and presented in Table 1. A majority of Total annualized costs—Estimates 360,000 service members who leave the total annualized private and private industry subsectors have veteran military service each year, according to employment of 7 percent or higher; the Government costs of the program. a 2013 White House report.2 In 2016 Costs for this regulation are uncertain, industries with the highest percentages there were 10 million veterans due partly to the program being entirely were the Petroleum and coal products employed according to data collected new with no obvious equivalents; VETS industry with 22.4 percent veteran cannot anticipate the number of from the Current Population Survey and employment, followed by Utilities with employers that will choose to reported by BLS, making up close to 7 20.5 percent veteran employment. The participate in the program. For this percent of the U.S. employed two industries with the lowest reason, this analysis contains estimates population. percentage of veteran employment are: that are based on very limited data. This The three leading industry sectors for Management of companies and is the first veteran hiring award veteran employment are manufacturing enterprises with 0.5 percent and established by VETS to recognize (North American Industry Classification Internet publishing and broadcasting employers for their accomplishments in System (NAICS) code 31–33), with, 1.3 and Web search portals with 1.0 percent recruiting, retaining, and hiring million veterans; wholesale and retail veteran employment. Other industry veterans. trade (NAICS code 42, 44–45) with 1.1 sectors where the percentage of veterans million veterans; and professional and employed is lower than the national Introduction business services (NAICS code 54–56) average are the healthcare and social The methodology for these estimates with 1.1 million veterans. Evaluating assistance sector with 3.5 percent, and will remain the same as those presented veteran employment as a percentage of the accommodations and food services in the NPRM. No public comments were total employment by industry highlights sector with 1.6 percent veteran received addressing the methodology for the various industries where veterans employment. The concentration of estimating costs of the regulation. VETS make up more than 7 percent of the veteran employment in utilities and did receive public comments related to employed population. Based on the manufacturing industries is a reflection some aspects of the analysis, as well as data, it appears there are many of the type of military experience many comments on the benefits to employers industries where a typical employer can veterans offer when seeking jobs that and veteran employees. VETS responds readily meet the basic criteria of hiring match their skill set.
TABLE 1—VETERAN EMPLOYMENT IN 2016
Veteran Total Percent of Industry employment 1 employment 2 veterans (in thousands) (in thousands) employed
Total Employment ...... 10,129 151,423 6.7 Mining, Quarrying, and Oil and Gas ...... 92 626 14.7 Construction ...... 588 6,711 8.8 Manufacturing ...... 1,285 12,348 10.4 Durable Goods Manufacturing ...... 898 7,719 11.6 Nonmetallic Mineral Products ...... 39 408 9.6 Primary Metals and Fabricated Metal Products ...... 156 1,763 8.8 Machinery Manufacturing ...... 125 1,080 11.6 Computers and Electronic Products ...... 113 1,048 10.8 Electrical equipment and Appliances ...... 30 383 7.8 Transportation Equipment ...... 269 1,625 16.6 Wood Products ...... 34 392 8.7 Furniture and Fixtures ...... 28 389 7.2 Miscellaneous Manufacturing ...... 103 591 17.4 Nondurable Goods Manufacturing ...... 387 4,629 8.4 Food Manufacturing ...... 92 1,554 5.9 Beverage and Tobacco Products ...... 26 233 11.2 Textiles, Apparel, and Leather ...... 23 371 6.2 Paper and Printing ...... 76 818 9.3 Petroleum and Coal Products ...... 25 112 22.4 Chemicals ...... 106 811 13.1 Plastics and Rubber Products ...... 38 699 5.4 Wholesale and Retail Trade ...... 1,090 21,687 5.0 Wholesale Trade ...... 260 5,867 4.4
1 BLS, DOL, Current Population Survey, 2016. 2 Watson, Ben, (2014) Veteran Unemployment Retrieved from: http://www.defenseone.com/news/ Rate Drops, But Still Outpaces the Rest of the 2014/05/D1-Watson-veteran-unemployment-rate- Country. www.defenseone.com, May 2, 2014. drops-still-outpaces-rest-country/83692/.
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TABLE 1—VETERAN EMPLOYMENT IN 2016—Continued
Veteran Total Percent of Industry employment 1 employment 2 veterans (in thousands) (in thousands) employed
Retail Trade ...... 830 15,820 5.2 Transportation and Utilities ...... 753 5,546 13.6 Transportation and Warehousing ...... 638 4,989 12.8 Utilities ...... 114 556 20.5 Information ...... 180 2,772 6.5 Publishing, Except Internet ...... 15 730 2.1 Motion Pictures and Sound Recording Industries ...... 13 420 3.1 Radio and TV Broadcasting and Cable Subscriptions Programming ...... 42 269 15.6 Internet Publishing and Broadcasting and Web Search Portals ...... 2 201 1.0 Telecommunications ...... 96 795 12.1 Data Processing, Hosting, and Related Services ...... 10 300 3.3 Libraries, Archives, and Other Information Services ...... 2 59 3.4 Financial Activities ...... 496 8,285 6.0 Finance and Insurance ...... 309 6,142 5.0 Finance ...... 174 3,559 4.9 Insurance ...... 135 2,583 5.2 Real Estate and Rental and Leasing ...... 187 2,143 8.7 Real Estate ...... 146 1,559 9.4 Rental and Leasing Services ...... 41 583 7.0 Professional and Business Services ...... 1,092 20,136 5.4 Professional and Technical Services ...... 658 8,877 7.4 Management, Administrative, and Waste Services ...... 433 11,259 3.8 Management of Companies and Enterprises ...... 11 2,241 0.5 Administrative and Support Services ...... 384 8,613 4.5 Waste Management and Remediation Services ...... 38 405 9.4 Education and Health Services ...... 826 22,616 3.7 Educational Services ...... 161 3,560 4.5 Health Care and Social Assistance ...... 664 19,056 3.5 Hospitals ...... 266 5,025 5.3 Health Services, Except Hospitals ...... 322 10,396 3.1 Social Assistance ...... 76 3,636 2.1 Leisure and Hospitality ...... 344 15,620 2.2 Arts, Entertainment, and Recreation ...... 128 2,235 5.7 Accommodation and Food Services ...... 216 13,386 1.6 Accommodation ...... 49 1,947 2.5 Food Services and Drinking Places ...... 167 11,439 1.5 Other Services ...... 351 5,685 6.2 Other Services, Except Private Households ...... 337 4,961 6.8 Repair and Maintenance ...... 150 1,289 11.6 Personal and Laundry Services ...... 68 1,445 4.7 Membership Associations and Organizations ...... 119 2,950 4.0 Government—Local 3 ...... 708 14,339 4.9 Source: 1 BLS, Current Population Survey, 2016. 2 BLS, Current Employment Statistics survey, 2016. 3 U.S. Census of Governments, 2012. (See Spreadsheets, Docket No. VETS–2017–0001–0002 for all sources and derivation).
The job posting site, Indeed.com, Due to the fact the award program availability of data in the U.S. Census identified five occupational categories requires a fee, it was determined that Bureau 2014 Statistics of U.S. where veterans have the highest levels employers with fewer than five Businesses (SUSB),4 which closely of employment: Transportation and employees are relatively unlikely to approximates the definition of small, material moving, installation participate in the program (although medium and large employers in the maintenance and repair, protective they are still eligible to apply for the statute. The SUSB data show a total of service, management, and construction award if they choose). Very small 2,379,033 employers with more than and extraction. Many veterans find the employers with fewer than five four employees. However, knowing the skills and experience they developed employees will most likely not hire percentage of veterans in an industry’s while in the military align better with often or may not choose to invest workforce does not indicate how many employers in that industry can meet the these occupations than with others, resources in actions that would qualify quantitative criteria for receiving the making the transition to a civilian job them for the award program, thus this easier.3 analysis contains three groupings of 4 U.S. Census Bureau, 2014. SUSB Annual employer size: Small employers with 5 Datasets by Establishment Industry: U.S. & States, 3 Culbertson, Daniel, (2016) A Deep Look at the to 49 employees; medium employers NAICS, detailed employment sizes. Accessed on Data: How Are Veterans Doing in Today’s with 50 to 499 employees; and large 6/15/2017 at: https://www.census.gov/data/ Workforce? Indeed blog, November 10, 2016. datasets/2014/econ/susb/2014-susb.html. Eligibility Retrieved from: http://blog.indeed.com/2016/11/10/ employers with 500 or more employees. estimates by VETS. See text and spreadsheets veterans-employment/. These groupings were based on the (Docket No. VETS–2017–0001–0002).
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award. For example, if 7 percent of an requirement for 75 percent retention. four employees, VETS estimates that industry’s workforce is veterans, there For this analysis, if we make the 424,952, or 18 percent of all employers will be many employers that are above simplifying assumptions that the in the three size ranges, would be and below this average in any given percentage of veterans currently in the potentially eligible for the program. year’s hiring. In order to estimate the workforce are typical of available new The complete formulas for the number of potentially eligible hires in an industry, and that each new probability calculations are given in the employers (those meeting the hire and each employee have an equal supplemental spreadsheets (Docket No. quantitative criteria) in an industry, we chance of being a veteran, then we can VETS–2017–0001–0002). There are four need to be able to estimate the effects of use the binomial distribution to estimate probabilities needed for these turnover on the ability to meet retention the probability that an employer has calculations: criteria, the percentage of employers more than 7 percent veterans among PH = the probability that more than 7 that hire veterans as 7 percent or more new hires or more than 7 percent percent of new hires are veterans; of their total number of new hires for veterans among existing employees. The PE = the probability that more than 7 the applicable time period, and the binomial distribution used here is percent of employees are veterans; percentage with 7 percent veterans in designed to calculate the probability their current workforces. The effects of that 7 percent or more employees in a PR = the probability that 75 percent of turnover on the ability to meet retention set of employees are veterans given the veteran hires are retained criteria may be the most difficult probability of an event (whether a given (estimated to be 0.5 in all cases); quantitative criteria to estimate. Average new hire or employee is a veteran). The and separation rates across all industries are application of the binomial distribution PLYH = the probability that an such that, if veterans’ rates are equal to requires estimates of the number of new employer hired at least one veteran the typical rates of all workers hires per year and the number of in the year prior to the current year. considered together, a 75 percent employees. For this purpose, VETS used Given these probabilities the formula retention rate would be difficult to 2014 SUSB 6 data on the number of used in the calculations for small and meet.5 However, published separation employers and employees for small medium employers is: rates include seasonal and temporary employers, medium employers and Total probability = PH + (1¥PH) * PE employments, which are excluded large employers. These averages of new * PLYH * PR under the definition of ‘‘employee’’ and hires were 13 employees per employer For large employers, the formula is subsequently from the calculation of for small employers, 123 employees per somewhat simpler: retention rates in this final rule. Absent employer for medium employers and ¥ comments on the methodology and 3,000 employees per employer for large Total Probability = PH + (1 PH) * more detailed data, VETS retains its employers. VETS estimated that these PLYH * PR assumption from the NPRM that half of employers would hire 25 percent of Table 2 shows the results for the the employers able to meet a 7 percent their workforce in any given year. Of the estimate of potentially eligible hiring rate will not be able to meet a 2,379,033 employers with more than employers by size class and industry.
TABLE 2—ESTIMATE OF ELIGIBLE EMPLOYERS
Potentially eligible employers Total Industry employers Small Medium Large (5+) employers employers employers Total (5–49) (50–499) (500+)
Forestry, Logging, Fishing, Hunting, and Trapping ...... 2,837 536 389 93 1,017 Mining, Quarrying, and Oil and Gas Extraction ...... 9,350 3,377 1,322 0 4,700 Construction ...... 204,561 51,059 8,464 915 60,438 Nonmetallic Mineral Products ...... 6,136 1,430 699 244 2,374 Primary Metals and Fabricated Metal Products ...... 35,064 7,638 3,613 1,025 12,276 Machinery Manufacturing...... 14,706 3,928 2,432 682 7,043 Computers and Electronic Products ...... 7,439 1,743 1,279 519 3,541 Electrical Equipment and Appliances ...... 3,359 553 398 210 1,161 Transportation Equipment ...... 6,458 2,121 1,575 550 4,246 Wood Products ...... 7,325 1,588 705 165 2,457 Furniture and Fixtures ...... 7,641 1,417 456 84 1,958 Miscellaneous Manufacturing...... 11,429 5,057 1,344 340 6,741 Food Manufacturing ...... 13,073 1,812 722 59 2,593 Beverage and Tobacco Products ...... 2,653 773 247 90 1,110 Textiles, Apparel, and Leather ...... 6,238 998 264 24 1,286 Paper and Printing ...... 14,483 3,426 1,404 350 5,179 Petroleum and Coal Products ...... 710 253 197 113 563 Chemicals ...... 6,476 1,746 1,341 589 3,676 Plastics and Rubber Products ...... 7,397 788 517 18 1,323 Wholesale Trade ...... 133,958 15,239 2,664 2 17,905 Retail Trade ...... 258,174 37,563 4,402 42 42,007 Transportation and Warehousing ...... 61,190 20,258 6,418 2,245 28,921 Utilities ...... 2,837 1,185 640 194 2,019 Publishing, Except Internet ...... 9,340 455 37 0 493
5 BLS Job Openings And Labor Turnover (2017). 6 U.S. Census Bureau, 2014. SUSB Annual 2014/econ/susb/2014-susb.html. Eligibility News Release; For release 10 a.m. (EDT), July 11, Datasets by Establishment Industry: U.S. & States, estimates by VETS. See text and spreadsheets 2017, https://www.bls.gov/news.release/pdf/ NAICS, detailed employment sizes. Accessed on (Docket No. VETS–2017–0001–0002). jolts.pdf. 6/15/2017 at https://www.census.gov/data/datasets/
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TABLE 2—ESTIMATE OF ELIGIBLE EMPLOYERS—Continued
Potentially eligible employers Total Industry employers Small Medium Large (5+) employers employers employers Total (5–49) (50–499) (500+)
Motion Pictures and Sound Recording Industries ...... 4,802 395 30 0 425 Radio and TV Broadcasting and Cable Subscriptions Pro- gramming ...... 2,857 1,127 344 111 1,582 Telecommunications ...... 3,705 1,097 498 160 1,755 Data Processing, Hosting, and Related Services ...... 4,885 334 88 0 422 Libraries, Archives, and Other Information Services ...... 3,237 269 37 0 307 Finance ...... 33,143 3,767 1,228 8 5,003 Insurance ...... 33,515 4,844 476 14 5,334 Real Estate ...... 47,711 12,428 2,509 778 15,714 Rental and Leasing Services ...... 9,613 1,774 424 166 2,364 Professional and Technical Services ...... 205,067 42,079 7,476 2,116 51,670 Management of Companies and Enterprises ...... 23,944 66 6 0 72 Administrative and Support Services ...... 108,014 12,007 2,405 3 14,415 Waste Management and Remediation Services ...... 8,782 2,240 570 168 2,977 Educational Services ...... 43,887 4,718 1,320 1 6,039 Hospitals ...... 3,407 16 388 36 441 Health Services, Except Hospitals ...... 247,348 20,285 1,726 0 22,011 Social Assistance ...... 67,460 3,486 270 0 3,756 Arts, Entertainment, and Recreation ...... 42,698 6,202 1,700 59 7,962 Accommodation ...... 29,467 1,935 130 0 2,065 Food Services and Drinking Places ...... 273,382 10,708 262 0 10,970 Repair and Maintenance ...... 61,091 20,895 1,820 610 23,325 Personal and Laundry Services ...... 58,697 7,987 395 0 8,382 Membership Associations and Organizations ...... 121,174 13,647 1,017 0 14,664 Government—Local ...... 40,882 0 8,273 0 8,273
Total ...... 2,311,602 337,247 74,922 12,784 424,952 Source: U.S. Census Bureau, 2014. SUSB Annual Datasets by Establishment Industry: U.S. & States, NAICS, detailed employment sizes. Accessed on 6/15/2017 at https://www.census.gov/data/datasets/2014/econ/susb/2014-susb.html. U.S. Census Bureau, 2012. Government Organization Summary Report: 2012. Accessed on 7/21/2017 at https://www2.census.gov/govs/cog/ g12_org.pdf. Eligibility estimates by VETS. See text and spreadsheets (Docket No. VETS–2017–0001–0002).
In the NPRM, data from BLS on collection, filling out the form, and manager at a large or medium employer veteran employment were presented as follow-up/requests for reconsideration. or by a person with equivalent a key input for estimating the number of VETS used the data from the May 2016 responsibilities at a small employer. eligible employers. VETS did not BLS Occupational Employment Using the data from the OES survey, the receive comments on the use of BLS Statistics (OES) survey. For the mean hourly wage of the human data for estimating the number of purposes of this analysis, VETS resources manager is $57.79. Adding employers meeting the criterion of 7 estimates a fully loaded wage rate to overhead and fringe benefits, the fully percent veteran employment. The include fringe benefits and overhead, loaded hourly wage rate being used to methodology presented in the NPRM to resulting in a doubling of the OES wage estimate the cost of familiarization is estimate the number of eligible rate.78 $115.58. The regulation is structured by employers has not been modified, Rule familiarization costs are employer size, which would not require although there were various estimated to take 1 hour for all employers to consider all aspects of commenters who recommended changes employers regardless of size; this is eligibility, but only those that pertain to to the regulation that could have based on the Occupational Safety and their size. For these reasons, 1 hour was impacts on the eligibility estimates. For Health Administration’s (OSHA’s) estimated for rule familiarization of the reasons explained in the responses to recordkeeping rule updated in 2014.9 award program requirements of public comments above, VETS did not This activity would typically be eligibility and the application form make changes to the rule in response to performed by a human resources instructions. public comments. Therefore, no changes The eligibility requirements for the were made to the employer eligibility 7 The value of two is recommended by HHS in award program require that all estimates used in the NPRM. HHS, Guidelines for Regulatory Analysis, 2016, p. employers compile information needed 33. to fill out the application form and Unit Cost 8 BLS OES survey (2017). Fringe markup is from retain the information for 2 years. VETS the following BLS release: Employee Costs for Using the information provided in the Employee Compensation news release text; For estimated this would require 5 hours for stakeholder meetings, as well as release 10:00 a.m. (EDT), June 9, 2017 https:// large employers and 3 hours for medium estimates from similar analysis done by www.bls.gov/news.release/pdf/ecec.pdf. and small employers. Each criterion for other DOL agencies, burden costs were 9 Occupational Injury and Illness Recording and eligibility will have an entry in the Reporting Requirements: North American Industry estimated by employer size for each Classification System Update and Reporting application form. Information requested aspect of the application process, Revisions (docket number: OSHA–2010–0019– will include the following: Employer including rule familiarization, 0127). address and other identifying
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information, veteran employment data, to collect and retain needed wage of $20.95 as reported in the BLS descriptions of the relevant veteran information. 2016 OES survey; with added fringe programs, and descriptions of the Large and medium employers are benefits and overhead, this results in an benefits offered to veterans. These expected to incur the cost for running a hourly wage of $41.90. estimates are an average for the gold and query to identify the number of veterans The form requires the attestation of an platinum award requirements. This hired and veterans retained for the years executive (chief executive officer, chief activity will likely be performed by requested on the application form. The human resources officer, or equivalent human resources specialists for a large majority of large and medium employers official) that the information on the form or medium employer. Using the data will have a database system for is accurate and true. It is expected that from the May 2016 BLS OES survey, the managing their workforce; this system this would take 15 minutes for all mean hourly wage of the human typically includes the hire date and employers applying for the award and resources specialist is $31.20. Adding various demographic information about would most likely require the executive overhead and fringe benefits, the fully their employees. Running a query to take the time to review the form. For specifically for this application form is loaded hourly wage rate used to a large or medium employer, this estimated to take 2 hours by a database estimate the collection of information is activity will be performed by an administrator at a large or medium $62.40. For a small employer, this executive with a mean hourly wage of employer according to comments activity is anticipated to be done by a $93.44 as reported in the BLS 2016 OES received from the stakeholder meeting survey; adding fringe benefits and payroll and timekeeping clerk, the mean in early June of 2017. Using the data hourly wage for this position as reported overhead, the hourly wage for this task from the May 2016 BLS OES Survey, the would be $186.88. At a small employer by BLS is $20.95, and adding the fringe mean wage of the database benefits and overhead results in an where the executive positions may not administrator is $41.89. Adding exist, this task may be done by someone hourly wage of $41.90. 11 overhead and fringe benefits, the total with equivalent responsibilities and Three hours of labor were estimated wage used to estimate the cost of this duties, such as the owner. For the by VETS for medium and small task is $83.78. Small employers with 50 purposes of estimating the cost of employers to compile information for or fewer employees typically do not attestation for small employers we are the form; this was determined based on manage their workforce using a using the wage rate of a human the number of award criteria, and due database, and due to the closer resources manager with a mean hourly to human resources staff in medium and interactions among employees at small wage of $57.79 as reported in the BLS employers, the payroll clerk would small employers being more familiar 2016 OES survey; adding fringe benefits know most of the employees with the day-to-day management of an and overhead results in a fully loaded individually. Thus, a small employer employer. At the stakeholder meetings wage for this task of $115.58. held the week of June 5, 2017, smaller would not have a need to run a query. Once the information has been Following up on incomplete employers stated all the information applications is estimated to take 30 needed to apply would come directly gathered by an employer, applicants will need to enter the information in the minutes for 5 percent of employers from the owner and would be easily form and enter the payment information applying, and a request for obtained. VETS estimated 5 hours for needed on www.pay.gov; this was reconsideration would take 30 minutes large employers due to the additional estimated to take 2 hours for a large for 1 percent of employers applying. At information required to match the employer, 1.5 hours for a medium a large or medium employer, following criteria for eligibility and the time for a employer, and 1 hour for a small up on an application would be done by human resources manager to determine employer. These burden estimates are the human resources specialist with an if the programs offered by the employer an average for the gold and platinum hourly wage of $62.40 (including fringe meet the regulation criteria. Larger award requirements. A large employer is benefits and overhead), and a request for employers at the stakeholder meetings expected to take 2 hours due to the reconsideration would be handled by a provided a range of 1 to 4 days, based additional criteria required to be eligible human resources manager with an on their past experience in applying for for the award; this activity would be hourly wage of $115.58 (including other award programs such as the done by a human resources specialist. A fringe benefits and overhead). At a small Employer Support of the Guard and medium employer is expected to take employer, the payroll clerk may likely Reserve (ESGR) Freedom Award.10 The 1.5 hours because there are fewer follow up on an application, with an application form for VETS’ award criteria than for a large employer; this hourly wage of $41.90 (including fringe program requires employers to provide activity would be done by a human benefits and overhead), and the human employment and descriptive resources specialist. Using the data from resources manager equivalent would be information for as many as seven fields the May 2016 BLS OES survey, the involved in a request for reconsideration to as few as one field depending on the mean wage of a human resources of a denied application, with an hourly size of the employer and the award specialist is $31.20. Adding overhead wage of $115.58 (including fringe level. This is less time consuming than and fringe benefits, the total wage used benefits and overhead). The majority of the information requested for the ESGR to estimate the cost of this task is large and medium employers have Freedom Award. For these reasons, an $62.40. A small employer is estimated human resources staff that manage average of 5 hours was estimated for to take 1 hour because there are fewer different aspects of the workforce, or large employers, and an average of 3 criteria than for a medium employer. outsource the managing of the database hours for medium and small employers, For a small employer, a payroll and for tracking the employer’s workforce timekeeping clerk would most likely over time. As a result, large and medium 10 The ESGR Freedom Award is given to perform this task, with a mean hourly employers are expected to have the employers who are nominated to recognize those same occupations involved in the that support their employees who serve in the 11 BLS OES (2017). Fringe markup is from the process of applying for the award, while United States National Guard or Reserve. There are following BLS release: Employee Costs for a different set of occupations were up to 15 awards presented each year by firm size Employee Compensation news release text; For and to the public sector. http:// release 10:00 a.m. (EDT), June 9, 2017 https:// identified for small employers, which www.freedomaward.mil/. www.bls.gov/news.release/pdf/ecec.pdf. typically do not have dedicated human
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resources staff or a database administrator.
TABLE 3—BURDEN COSTS BY EMPLOYER SIZE *
Tasks by employer size Resource Wage Hours Cost
Large Employer Activities: Rule familiarization ...... HR manager ...... $116 1.0 $116 Data collection large employers ...... HR specialists ...... 62 5.0 310 Query report large employers ...... DB Administrators ...... 84 2.0 168 Filling form, large employers ...... HR specialists ...... 62 2.0 125 Executive signature ...... Executive ...... 187 0.25 47 Follow up (assume 5 percent) ...... HR specialists ...... 62 0.5 31 Reconsideration if denied award (1 percent) .... HR manager ...... 116 0.5 58
Average unit cost per employer ...... 855 Medium Employer Activities: Rule familiarization ...... HR manager ...... 116 1.0 116 Data collection medium employers ...... HR specialists ...... 62 3.0 186 Query report medium employers ...... DB Administrators ...... 84 2.0 168 Filling form medium employers ...... HR specialists ...... 62 1.5 93 Executive signature ...... Executive ...... 187 0.25 47 Follow up (assume 5 percent) ...... HR specialists ...... 62 0.5 31 Reconsideration if denied award (1 percent) .... HR manager ...... 116 0.5 58
Average unit cost per employer ...... 699 Small Employer Activities: Rule familiarization ...... HR manager ...... 116 1.0 116 Data collection small employers ...... Payroll and timekeeping clerks ...... 42 3.0 126 Filling form, small employers ...... Payroll and timekeeping clerks ...... 42 1.0 42 Executive signature ...... HR manager ...... 116 0.25 29 Follow up (assume 5 percent) ...... Payroll and timekeeping clerks ...... 42 0.5 21 Reconsideration if denied award (1 percent) .... HR manager ...... 116 0.5 58
Average unit cost per employer ...... 392 Source: BLS, OES 2016. * Wages and costs are rounded values. (See Spreadsheets, Docket No. VETS–2017–0001–0002 for all sources and derivation).
The burden estimates were mainly associated with filling out the forms. annualized over 10 years at a 3 percent driven by the duration of time expected However, as explained in the responses discount rate results in a cost of for each aspect of the application to public comments above, VETS did $109,388 per year. process, and the type of occupation not make any changes to the award The business process for the intake, identified as performing the various criteria in response to public comments. review, and processing of applications activities for the employer size. Therefore, no changes were made to the was estimated using average wage data The rulemaking docket includes a unit cost estimates used in the NPRM. from BLS occupation codes for each spreadsheet used to estimate the unit In the NPRM, estimates for cost and phase, including solicitation, costs to employers who apply for the burden were based on comments application processing, application award. The unit costs in the spreadsheet received from stakeholder meetings and review, award notification, and included burden costs by employer size OSHA’s recordkeeping rule update in reporting to Congress. The cost to the for each aspect of the application 2014. Government for processing is estimated process, including rule familiarization, Government Costs to be $2.5 million dollars per year based collection, filling out the form, and on 10,000 applications being processed follow-up/requests for reconsideration. The cost to the Government involves per year. VETS received a few public comments the intake, review, verification, and As part of the business process there related to these aspects of the cost processing of the applications, and will be costs associated with program estimation. For example, a commenter notification/distribution of the award. outreach, messaging, and notification of stated that there are ‘‘small employer[s] To efficiently process applications, award winners. This is estimated to cost who may lack a dedicated Human VETS will develop and maintain a $245,086 annually. An outreach Resources professional, and rel[y] on the system to electronically receive specialist is estimated to spend 1,140 AJC staff for many hiring functions.’’ applications, review applications to hours involved in these tasks. The mean VETS agrees that smaller employers determine eligibility, and issue the hourly wage rate for an outreach often will not employ the same type of awards. The cost for such a system specialist is $45.42, as reported by the human resources professionals as would include IT hardware and Office of Personnel Management (OPM) medium or larger employers do, and software, IT maintenance, helpdesk for a General Schedule (GS)–13 (Step 1) this is reflected in the cost estimates and costs, and VETS program management in 2017; 12 plus fringe benefits and criteria for applying. Other commenters personnel costs. VETS has estimated suggested changes in certain program lifecycle costs. The estimated cost of 12 OPM https://www.opm.gov/policy-data- criteria, which, if adopted by VETS, creating an application system and form oversight/pay-leave/salaries-wages/salary-tables/ could have impacted unit costs is approximately $933,100, which pdf/2017/DCB_h.pdf.
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overhead, the hourly wage for this task a loaded hourly wage of $126.28 would to cover the costs associated with would be $90.84. These tasks will also spend 2 minutes per employer on the carrying out the HIRE Vets Act. The fee involve a program manager spending list verifying the findings in the initial will cover the costs of solicitation of 1,000 hours with an hourly wage rate of check. The IT process developed to applications, processing applications, $53.67 (GS–14 Step 1); plus fringe support this review will be maintained vetting applicants for labor law benefits and overhead, the hourly wage by a contractor 17 spending 240 hours, violations, and award notifications, as would be $107.36. An IT specialist (GS– with a loaded hourly wage of $84.50 well as the maintenance cost of the IT 12 Step 1) would also be involved in (hourly mean wage from BLS without system used in the processing of supporting tasks with messaging and fringe benefits or overhead is $42.25). applications. recognition of award winners, spending The notification of the award will also In processing the applications, VETS 100 hours, with an hourly wage of be executed by a contractor, and it will will need to verify the information on $38.20; plus fringe benefits and involve 50 hours of a program the form being submitted by employers. 18 overhead, the hourly wage would be manager’s time, with a loaded hourly Given that the number of criteria varies $76.40. wage of $117.40, and 40 hours of a by employer size, and will consequently The application process will require 16 program specialist’s time, with a require additional review by VETS, the support from contractors to set up the loaded hourly wage of $71.98. fee will vary by employer size to reflect process, the receipt of the forms and the The oversight of the contract for the processing of the applications; this is the cost of reviewing additional criteria. application processing will be done by For example, the large employer estimated to cost $1,896,940 annually. A VETS personnel. This will take 312 program specialist will spend 200 hours platinum award requires the applicant hours of a program manager’s time (GS– to provide information about five types annually with a mean hourly wage rate 14), with a loaded hourly wage of of $59.31 as reported in the BLS 2016 of integration assistance. However, the $107.36, and 120 hours of a program small employer platinum award only OES survey; 13 plus fringe benefits and specialist’s time (GS–13), with a loaded overhead, the hourly wage rate would requires that the applicant provide hourly wage of $90.84. information about two types of be $118.62. An IT specialist will spend The statute requires a report to integration assistance. Consequently, 40 hours to support these activities with Congress; this will be done by VETS the large employer award will take an hourly wage rate of $42.25; 14 plus personnel, and it will cost a total of longer to review than the small fringe benefits and overhead, the hourly $10,406 dollars annually. This task will employer award will. wage is $84.50. The program manager 15 take a program manager (GS–14), 80 is estimated to spend 151 hours hours with a loaded hourly wage of In recognition of these differences in processing applications, with an hourly $107.36, and another 20 hours of time the number of criteria and the amount wage rate of $58.70; plus fringe benefits for a program specialist’s time (GS–13), of information needing to be reviewed and overhead, the hourly wage is with a loaded hourly wage of $90.84. and verified as part of processing $117.40. A program specialist 16 will The cost to the Government was awards, the fees will be graduated to perform the bulk of the application estimated in two parts: The costs to reflect the differences in the amount of review tasks, totaling 18,569 hours with efficiently process applications and the review VETS would need to perform for an hourly wage rate of $35.99; plus costs of creating the application system. large, medium, and small employers. fringe benefits and overhead, the hourly VETS solicited comments on the costs The fee for large employers is $495 per wage will be $71.98. to the Government to develop a system applicant, the fee for medium employers As part of the review process of the to accept and review applications but is $190 per applicant, and the fee for applications, VETS will need to verify none were received. small employers is $90 per applicant, applicants do not have adverse labor The supplemental spreadsheet in the which covers the anticipated cost to law decisions, stipulated agreements, docket includes the methodology used VETS for processing 4,152 applications contract debarments, or contract in the NPRM to estimate the costs to the in the first year. The fees were estimated terminations against them under Government to process the application by taking the average cost to VETS of USERRA; or the VEVRAA. This and the creation of the application $300 per application, and multiplying it verification process will involve VETS system; no changes are being made to using factors of time that reflect the and OFCCP checking their databases for the Government cost calculations. information needed to be reviewed. award applicants. VETS estimates it will Large employers would take VETS 1.6 take each agency, OFCCP and VETS, an Application Fee times longer than the estimated average average of 15 minutes per application The HIRE Vets Act provides that the cost to process the application; for for this review. A GS–13 would perform Secretary may assess a reasonable fee on medium employers it would be 0.6 the check with a loaded hourly wage of employers that apply for receipt of a times the average cost, and for small $90.84 and spend 13 minutes per HIRE Vets Medallion Award and that employers it would be 0.3 times the employer on the list, and a GS–15 with the amount of the fee must be sufficient average cost.
TABLE 4—GOVERNMENT COSTS
Employers Application processing 4,152 6,228 10,728
Solicitation ...... $245,086 $245,086 $245,086 Receipt and Processing ...... 565,828 823,693 1,382,564 Violation Vetting by VETS and OFCCP ...... 200,119 299,335 514,376
13 BLS OES occupation code 11–2031 Public 15 BLS OES occupation code 11–1021 General 17 BLS OES occupation code 15–0000 Computer Relations and Fundraising Managers. and Operations Managers. and Mathematical Occupations. 14 BLS OES occupation code 15–0000 Computer 16 BLS OES occupation code 13–1199 Business 18 BLS OES occupation code 11–1021 General and Mathematical Occupations. Operations Specialists. and Operations Managers.
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TABLE 4—GOVERNMENT COSTS—Continued
Employers Application processing 4,152 6,228 10,728
Award Notification ...... 160,333 236,118 400,366 Contract Oversight ...... 44,397 44,397 44,397 IT Support and Maintenance ...... 20,280 20,280 20,280 Report to Congress ...... 10,406 10,406 10,406
Total Processing Cost ...... 1,246,449 1,679,315 2,617,473 Average Government Cost per Application ...... 300 270 244 Sunk Development Costs: Development of Application System ...... 98,625 Application Form Development ...... 834,474
Total Development Costs ...... 933,099 Source: OSHA, Directorate of Standards and Guidance, Office of Regulatory Analysis. (See Spreadsheets, Docket No. VETS–2017–0001–0002 for all sources and derivation). Average cost per application = total processing cost/# of employers.
The proposed fee in the NPRM was There were no comments on the on an earlier version of the HIRE Vets estimated to cover the cost to the estimated level of participation; these bill. If CBO had included small Government, which includes estimates will stay the same. As employers in their estimate using the solicitation of applications, processing indicated in the Summary and same methodology, the number of applications, vetting applicants for labor Explanation section of this document, employers applying would increase to law violations, and award notifications, some commenters expressed doubt that close to 50,000 employers. as well as the maintenance cost of the employers would be interested in As noted above, VETS, making use of IT system used in the processing of participating in the HIRE Vets BLS veterans’ labor force participation applications. VETS did not receive Medallion Program but no commenter rate data, estimates that far more than 2 comment on the cost estimates for the provided specific data or evidence percent of employers that are eligible Government, nor the estimated regarding how this supposition would may choose to participate. Due to the graduated fee by employer size. impact the participation rates estimated The same calculation found in the in the NPRM. lack of data for more accurate spreadsheet and discussed in the NPRM CBO originally developed an estimate participation rates, VETS assumes that is used to derive a graduated application that 4,000 employers would participate approximately 4,152 employers will fee by employer size. in the program in the first year. This apply in the first year, but that this estimate was based on the assumption would increase to 6,228 employers in Participation and Costs per Year that only 2 percent of employers would the second year and to 10,728 per year VETS based its estimates of the level be potentially eligible and 25 percent of in succeeding years. Table 5 shows the of participation partly on the CBO medium and large employers potentially estimated participation rates by estimate of 4,000 employers in the first eligible would apply for the program. In employer size class for each year and year and on the impact the criteria CBO’s estimate, small employers were the resulting estimated costs of would have on the participation levels. excluded from being able to apply based applications.
TABLE 5—ESTIMATED PARTICIPATION RATES AND NUMBERS OF APPLICANTS BY YEAR
1st year 1st year 2nd year 2nd year 3rd year 3rd year Size class participation participation participation rate number of rate number of rate number of (%) applicants (%) applicants (%) applicants
Small ...... 0.1 304 0.2 674 0.6 2,023 Medium ...... 3.0 2,248 4.0 2,997 6.5 4,870 Large ...... 12.5 1,601 20.0 2,557 30.0 3,835
Total ...... N/A 4,152 N/A 6,228 N/A 10,728 VETS Estimates (See Spreadsheets, Docket No. VETS–2017–0001–0002 for all sources and derivation).
Table 6 shows the results of number of anticipated participants to incurred by the employer when multiplying the employer unit costs of obtain the costs by size class and total applying for the award program; this applying for the award, developed in application costs for each year. These includes all the tasks discussed in the the previous Unit Cost section, by the costs reflect the time and resources previous Unit Cost section.
TABLE 6—EMPLOYER APPLICATION COSTS BY YEAR
Size class 1st year costs 2nd year costs 3rd year costs
Small ...... $95,215 $211,589 $634,767
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TABLE 6—EMPLOYER APPLICATION COSTS BY YEAR—Continued
Size class 1st year costs 2nd year costs 3rd year costs
Medium ...... 1,377,355 1,836,473 2,984,269 Large ...... 1,230,468 1,965,603 2,948,405
Total ...... 2,703,038 4,013,665 6,567,441 VETS Estimates (See Spreadsheets, Docket No. VETS–2017–0001–0002 for all sources and derivation).
There are multiple factors that would didn’t specify a fee amount they would result in increased costs relative to the contribute to the participation rate of be willing to pay. It would seem overall cost burden and overall large, medium, and small employers, reasonable to assume a fee of more than Government cost. However, considering such as the application fee, amount of several hundred dollars would all costs, the program will most likely outreach by VETS, and the potential discourage many small employers from not have costs in excess of $100 million benefits gained by the employers applying. The total cost, burden plus per year. Such costs would only occur receiving the award. The problem here fees, is estimated to range from $404 for if 100 percent of potentially eligible is a classically difficult one in small employers to $1,264 for large medium and large employers and 25 economics—that of estimating demand employers. Depending on the success of percent of potentially eligible small for new products. In this case, we have outreach and other messaging, these employers apply every year. little data and few comparable products efforts could attract more applicants on which to base an estimate. VETS is than CBO’s estimate. Over the long Total Annualized Costs aware that the total costs are dependent term, employers will want to apply if on the number of employers that apply there are quantifiable benefits in the VETS estimated annualized costs to and the number could be much lower or form of increased revenue if this award employers for participation in this higher than VETS’ baseline estimates. attracts more customers, and by award program over a 10-year period At the stakeholder meetings, some increasing the pool of veteran applicants using 3 percent and 7 percent discount representatives from larger employers when they are hiring. These factors have rates based on the costs of application stated their willingness to pay up to the potential to increase the number of and costs to the Government developed several thousand dollars, while participating employers to close to above. These total costs are provided in representatives for smaller employers 50,000. Higher participation would Table 7.
TABLE 7—TOTAL ANNUALIZED COSTS OF THE FINAL RULE
First year costs (if Cost element Annualized Annualized different from costs at 3% costs at 7% annualized costs)
Costs for Preparing Applications ...... $5,845,415 $5,735,649 $2,703,038 Costs to Government of Processing Application (to be reimbursed through fees) ...... 2,357,854 2,318,462 1,246,449 Total Private Sector Costs, Including Fees for Government Processing ...... 8,203,269 8,054,111 3,949,487 Costs to Government for Developing System (not reimbursed by fees) ...... 109,388 132,852 933,099
Total ...... 8,312,657 8,186,963 4,882,586 VETS Estimates (See Spreadsheets, Docket No. VETS–2017–0001–0002 for details).
Alternatives by 19 percent, and increased annualized timeframe. This option would have also costs from approximately $8 million per slightly increased program eligibility, VETS considered alternative year to $11.9 million a year. This but it would have done so by quantitative criteria for small and alternative had the disadvantage that it significantly increasing small employer medium employers. One alternative would have been to change the would have allowed employers who had eligibility while lowering eligibility for proposed criteria for small and medium not recently achieved a 7 percent hiring medium employers. VETS concluded employers that require applicants to goal to win the award. that this was not a useful effect given have both a retention rate of 75 percent VETS also considered an option in that medium employers are more likely (for gold)/85 percent (for platinum) and which small and medium employers to participate in the program than small a veteran employee percentage of 7 could have qualified if they met either employers are. percent (for gold)/10 percent (for of the following: (1) 7 percent of the VETS also examined an option in platinum). Instead, this first proposed employer’s new hires during the which the only hiring and retention alternative criterion would have previous year were veterans, or (2) 7 criteria for small and medium dropped the veteran employee percent of the employees it hired over employers would have been that 7 percentage requirement. Keeping all the the last 2 years were veterans and the percent of new hires over the last 2 participation rates the same, VETS employer retained 75 percent of those years were veterans along with a 75 estimates that this change would have veterans hired in the first year of that percent retention criterion from the first increased the number of potentially timeframe (previous year of the previous of the 2 years (previous year of the eligible employers by 38 percent, year). This alternative would have previous year). Under this option, increased participation in the program broadened the hiring eligibility employers would no longer have been
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able to satisfy the hiring and retention focused attention, and the ability to tuition reimbursement, ‘‘reduced criteria solely by having 7 percent of work independently.20 Employers who employee turnover and lower[ed] their new hires in the previous year be attain the award will be able to market recruiting costs,’’ demonstrating the veterans. This approach also would themselves as a veteran friendly financial benefit these programs can have increased small employer employer and be able to attract more have to employers’ bottom lines.21 eligibility at the expense of decreasing veterans for job openings. Employee resources groups, leadership medium employers’ eligibility. Again, VETS received some comments training, differential pay, and tuition because of expected high participation regarding the benefits described in the reimbursement have all been shown to rates by medium employers relative to NPRM. The purpose of the HIRE Vets reduce turnover.22 In an article from the small employers, VETS decided not to Medallion Award is to recognize Huffington Post, ‘‘How Much Does adopt this alternative. employers who have recruited and Employee Turnover Really Cost,’’ None of these estimates take into retained veterans, as well as the efforts posted on January 19, 2017, the author account the cost savings to both the by these employers to establish found that ‘‘the cost of losing an private sector and the Government of employee development programs for employee can range from tens of these alternatives. veterans and to offer veteran specific thousands of dollars to 1.5–2.0x the VETS solicited comments on these benefits to improve retention. Those employee’s annual salary.’’ As these proposed alternatives for medium and employers who meet the criteria to articles demonstrate, employers small employers but did not receive any receive the award most likely recognize applying for a HIRE Vets Medallion specific comments to the alternatives the benefits of employing veterans and Award are reaping many benefits, and proposed. Therefore, the criteria would want to attract more veteran this award will allow them to maximize presented in the NPRM will not change employees in the future. A recipient of the return on their investment in the for the final rule and VETS will not this award would have the opportunity employee programs they offer. adopt the alternatives discussed here. to utilize the medallion in the marketing Attaining awards can also result in Benefits of their firm when hiring, as well as to benefits to businesses in the form of attract additional business. One increased marketing potential, improved VETS expects that employers will commenter stated that employers standing in their industry, recognition want to apply for the award if there are already have a means to ‘‘advertise that as a leader, and improved employee quantifiable benefits in the form of they hire vets,’’ concluding that this engagement.23 These benefits discussed increased revenue generated by award would not result in new added are all reasons that businesses attracting more or repeat customers, or benefits to employers. In addition, a participate in awards and offer a better pool of veteran applicants for couple commenters questioned if employee development programs. jobs. employers would be interested in Regulatory Flexibility Certification The unemployment rate of veterans applying given the burden of applying trends lower than the civilian and the lack of quantifiable benefits. For regulatory flexibility purposes for unemployment rate, but regionally, the While benefits were not quantified, the this rule, economic impacts are unemployment rate for veterans can employers in the stakeholder meetings considered significant in any given vary from a low of 1.8 percent in and in the 2016 Forbes article 19 sector if costs are greater than 1 percent Indiana to a high of 7.6 percent in the discussed above both asserted that there of revenues or 5 percent of profits. For District of Columbia, as reported in the are benefits employers receive from the purpose of determining impacts on March 2016 Employment Situation of hiring veterans, and this award will small employers, VETS considered costs Veterans release by BLS. The higher enable employers to attract more as a percentage of revenues and profits unemployment rate for veterans in the veterans to their job openings. by industry sector for employers with 5 District of Columbia can be attributed to Other comments supported the idea to 500 employees. (Note that this the labor market there, which is mostly that a HIRE Vets Medallion Award definition of ‘‘small employers’’ is composed of professional and service would yield tangible benefits to consistent with SBA’s definition and industry occupations where historically employers. For example, a commenter differs from that established by Congress there are lower employment rates for expressed that ‘‘[o]nce employers who for purposes of the HIRE Vets Medallion veteran workers. These veterans are participate in this program start hiring Program.) Table 8 shows the minimum experienced, mission-focused, more veterans, other companies will see and maximum impacts for each 3-digit responsible, independent, and capable the positive impact it has on business subsector within the 2-digit sector workers who often face difficulties and hopefully will follow in the same shown. (Full impacts and derivation are finding jobs that match their skills. In a direction’’ (VETS–2017–0001–0018). given in the supplemental spreadsheets, 2016 Forbes article 19 highlighting This award program was mandated by Docket No. VETS–2017–0001–0002.) veterans’ issues as they adjusted to the an act of Congress to recognize those Table 8 shows that no industry sector civilian workforce, the top challenges employers who currently meet those has costs in excess of 1 percent of reported for veterans are a lack of criteria in hiring, retaining, and revenues or 5 percent of profits. training or education for the work, lack supporting veteran employees. These of advancement opportunities, and employers have engaged with veteran 21 Mulhere, Kaitlin, (2016) Paying Their Workers’ employers undervaluing their military College Tuition Can Pay Off for Companies. April employees because there are benefits 25, 2016. Retrieved from: http://time.com/money/ experience. gained, but as stated above, these 4305549/paying-their-workers-college-tuition-can- Many employers who seek out benefits are not easily quantified. A pay-off-for-companies/. veterans to hire have stated there are Time article from April 25, 2016, 22 Altman, Jack, (2017) How Much Does many benefits in attracting veterans, Employee Turnover Really cost? January 18th, 2017. ‘‘Paying Their Workers’ College Tuition Retrieved from: https://www.huffingtonpost.com/ such as the experience they bring, more Can Pay Off for Companies,’’ stated that entry/how-much-does-employee-turnover-really- cost_us_587fbaf9e4b0474ad4874fb7. 19 Strauss, Karsten, (2016) How Veterans Adjust 20 Military & Defense team, (2016) 10 Reasons 23 Narayanan, Sukruti, (2017) The 5 Benefits of To The Civilian Workforce, November 11th, 2016. Companies Should Hire Military Veterans, Receiving Corporate Awards. January 15, 2017. Retrieved from: https://www.forbes.com/sites/ November 11, 2016. Retrieved from: http:// Retrieved from: https://www.linkedin.com/pulse/5- karstenstrauss/2016/11/11/how-veterans-adjust-to- www.businessinsider.com/reasons-companies- benefits-receiving-corporate-awards-sukruti- the-civilian-workforce/2/#2d316ff8395d. should-hire-military-veterans-2016-11. narayanan.
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TABLE 8—ECONOMIC IMPACTS
Average cost Average cost Average to revenues to profits NAICS Title revenue per establishment Minimum Maximum Minimum Maximum (%) (%) (%) (%)
11 ...... Agriculture, Forestry, Fishing, and Hunt- 4,244,996 0.009 0.026 0.176 0.844 ing. 21 ...... Mining ...... 13,371,157 0.002 0.009 0.068 0.068 22 ...... Utilities ...... 21,521,736 0.003 0.003 ¥0.220 * ¥0.220 * 31–33 ...... Manufacturing ...... 10,225,679 0.002 0.021 0.030 0.485 42 ...... Wholesale Trade...... 20,024,426 0.002 0.006 0.014 0.203 44–45 ...... Retail Trade...... 3,928,643 0.005 0.042 0.243 0.243 48–49 ...... Transportation ...... 5,700,083 0.004 0.039 0.051 4.545 51 ...... Information ...... 4,990,489 0.009 0.020 ¥0.165* 0.192 52 ...... Finance and Insurance...... 5,367,956 0.007 0.019 0.015 0.314 53 ...... Real Estate...... 4,371,291 0.007 0.025 0.038 0.566 54 ...... Professional, Scientific, and Technical 2,986,458 0.020 0.020 0.517 0.517 Services. 55 ...... Management ...... 2,306,072 0.026 0.026 0.131 0.131 56 ...... Administrative and Support, Waste Man- 2,727,336 0.018 0.030 0.426 0.765 agement and Remediation Services. 61 ...... Educational Services...... 2,514,535 0.024 0.024 0.522 0.522 62 ...... Health Care...... 8,435,099 0.003 0.051 0.052 0.964 71 ...... Arts, Entertainment, and Recreation ...... 2,963,512 0.014 0.039 0.236 2.414 72 ...... Accommodation and Food Services ...... 1,381,321 0.033 0.065 0.505 1.224 81 ...... Other Services ...... 1,319,709 0.030 0.094 1.222 2.905 Source: VETS based on data from IRS (U.S. Internal Revenue Service), 2013. Corporation Source Book, 2013. https://www.irs.gov/statistics/ soi-tax-stats-corporation-source-book-us-total-and-sectors-listing, Accessed by Eastern Resource Group, Inc., 2016. U.S. Census Bureau, 2012. SUSB Employment and Payroll Summary: 2012-Data by enterprise employment size, Accessed on 7/11/2017 at https://www.census.gov/data/tables/2012/econ/susb/2012-susb-annual.html. See Spreadsheets, Docket No. VETS–2017–0001–0002, for full derivation. *Negative profit rates reported for these industries.
As a result of these considerations, 2016. From: http://blog.indeed.com/ Watson-veteran-unemployment-rate- per section 605 of the Regulatory 2016/11/10/veterans-employment/. drops-still-outpaces-rest-country/83692/. Flexibility Act (RFA), VETS certifies VETS based on data from IRS (U.S. Internal U.S. Census Bureau, 2014. SUSB Annual that this final rule will not have a Revenue Service), 2013. Corporation Datasets by Establishment Industry: U.S. SourceBook, 2013. https://www.irs.gov/ & States, NAICS, detailed employment significant economic impact on a statistics/soi-tax-stats-corporation- sizes. Accessed on 6/15/2017 at https:// substantial number of small entities. source-book-us-total-and-sectors-listing, www.census.gov/data/datasets/2014/ VETS did not receive comments on Accessed by ERG, 2016. econ/susb/2014-susb.html. Eligibility this certification. Further, it should be Fleishman, 2014. Hilton Helping Veterans estimates by VETS. See text and noted that small employers are only with Jobs, Free Hotel Stays. G.I. Money, spreadsheets (Docket No. VETS–2017– subject to this rule if they choose to January 16, 2016. From: http:// 0001–0002). apply for the award. Thus, no small gimoney.com/hilton-helping-veterans- jobs-free-hotel-stays/. Paperwork Reduction Act business needs to incur the costs unless HHS, 2016. Guidelines for Regulatory Overview they find that the benefits exceed the Analysis. Page 33, available at https:// costs for them. aspe.hhs.gov/system/files/pdf/242926/ The final HIRE Vets Medallion Award _ regulations contain collections of References HHS RIAGuidance.pdf. Military & Defense team, 2016. 10 Reasons information (paperwork) requirements Altman, 2017. How Much Does Employee Companies Should Hire Military that are subject to review by OMB. The Turnover Really cost? Veterans, November 11, 2016. From: Paperwork Reduction Act of 1995 Huffingtonpost.com January 18, 2017. http://www.businessinsider.com/ (PRA), 44 U.S.C. 3501 et seq., and its From: https://www.huffingtonpost.com/ reasons-companies-should-hire-military- implementing regulations, 5 CFR part entry/how-much-does-employee- veterans-2016-11. 1320, require that the Department turnover-really-cost_us_ Occupational Injury and Illness Recording 587fbaf9e4b0474ad4874fb7. and Reporting Requirements: North consider the impact of paperwork and BLS, 2016. Current Population Survey. American Industry Classification System other information collection burdens Available at www.bls.gov/cps. Update and Reporting Revisions (Docket imposed on the public. A Federal BLS, 2017. Job Openings And Labor No. OSHA–2010–0019–0127). agency generally cannot conduct or Turnover—July 11, 2017. Available at Strauss, 2016. How Veterans Adjust To The sponsor a collection of information, and https://www.bls.gov/news.release/pdf/ Civilian Workforce, November 11, 2016. the public is generally not required to jolts.pdf. From: https://www.forbes.com/sites/ respond to an information collection, BLS, 2017. OES. Fringe markup is from the karstenstrauss/2016/11/11/how- unless it is approved by OMB under the following BLS release: Employee Costs veterans-adjust-to-the-civilian- PRA and displays a currently valid for Employee Compensation—June 9, workforce/2/#2d316ff8395d. 2017. Available at https://www.bls.gov/ Watson, 2014. Veteran Unemployment Rate OMB Control Number. In addition, news.release/pdf/ecec.pdf. Drops, But Still Outpaces the Rest of the notwithstanding any other provisions of Culbertson, 2016. A Deep Look at the Data: Country. www.defenceone.com, May 2, law, no person may generally be subject How Are Veterans Doing in Today’s 2014. From: http:// to penalty for failing to comply with a Workforce?. Indeed blog, November 10, www.defenseone.com/news/2014/05/D1- collection of information that does not
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display a valid OMB Control Number. 2018, before the implementation of this FINAL REGULATORY PROVISION— See 5 CFR 1320.5(a) and 1320.6. rule; this demonstration would not Continued involve the collection of application Solicitation of Comments fees. Employer Gold award Platinum On August 18, 2017, VETS published The regulations implementing the size award two separate Federal Register Notices HIRE Vets Act require the Secretary that allowed the public an opportunity annually to solicit and accept voluntary Small ...... § 1011.110(a) § 1011.110(b) to comment on the proposed information from employers for Information Collection Request (ICR) consideration of employers to receive a The applications solicit information containing the collections of HIRE Vets Medallion Award. The Act that VETS will review and evaluate to information contained in the proposed establishes specific criteria at two determine if an employer will receive an regulations and the HIRE Vets levels, ‘‘Gold’’ and ‘‘Platinum,’’ for large award. Employers are required to Medallion Award application and employers (those with 500 or more maintain information relied upon to forms. First, in accordance with the PRA employees) and allows the Secretary complete their application for 2 years, (44 U.S.C. 3507), the HIRE Vets discretion in establishing criteria for as previously noted. VETS may request Medallion Program NPRM provided 30 small and medium employers to qualify this information if additional days for the public to comment on the for similar awards. verification is needed, or in case VETS ICR (82 FR 39390). However, the PRA The final rule includes the becomes aware of facts that may requires that agencies provide a 60-day application process and criteria VETS indicate information submitted on the public comment period on the will use to receive, review, and process application may be incorrect. collections of information in accordance applications; verify the information Title of Collection: Honoring with 44 U.S.C. 3506(c). As a result, provided; and award the HIRE Vets Investments in Recruiting and VETS published a second companion Medallion Award to those employers Employing American Military Veterans notice to the NPRM (82 FR 39460) meeting the criteria. VETS developed Act. allowing the public the full 60 days to the HIRE Vets application forms [VETS– OMB Control Number: 1293–0015. comment on the collections of 1011LP, VETS–1011LG, VETS–1011MP, Total Estimated Number of information contained in the proposal. VETS–1011MG, VETS–1011SP, VETS– Respondents: 7,036. On August 18, 2017, VETS submitted an 1011SG] for employers to complete and Total Estimated Number of ICR for the proposed rule to OMB for submit to VETS to fulfill the regulatory Responses: 34,245. review in accordance with 44 U.S.C. requirements to receive an award. The Total Estimated Annual Time Burden 3507(d). Act establishes a fund, designated as the Hours: 58,716. On October 25, 2017, OMB issued a ‘‘Hire Vets Medallion Award Fund,’’ Total Estimated Annual Other Costs Notice of Action (NOA) commenting on and allows the Secretary to assess a Burden: $1,847,746. the proposal’s ICR. OMB commented reasonable fee from the applicants to Small Business Regulatory Enforcement that the NOA is not an approval to cover the costs associated with carrying Fairness Act of 1996 conduct or sponsor the collections of out the HIRE Vets Medallion Program. VETS has determined that this final information contained in the proposal. The final rule provides the fee amount rule does not impose a significant OMB noted that this action has no effect and how to submit the fee. economic impact on a substantial on any current approvals and assigned The final rule, like the proposed rule, number of small entities under the RFA; the ICR control number 1293–0015 to be provides specific award criteria for large therefore, VETS is not required to used in future ICR submissions. Also, employers to qualify for the gold and produce any Compliance Guides for OMB instructed the Agency to resubmit platinum awards. Although the number Small Entities, as mandated by the this ICR when the final rule is issued. of criteria an employer is required to Small Business Regulatory Enforcement satisfy in the final rule differs by award, Collection of Information Requirements Fairness Act for rules with such the large employer criteria established VETS received comments addressing impacts. the collections of information and the by statute are generally incorporated burden hour cost analysis. Responses to across the large employer, medium Unfunded Mandates Reform Act of these comments are found in the employer, and small employer awards. 1995 Section-by-Section Summary of the The applications require employers to For purposes of the Unfunded Final Rule and Discussion of Comments provide information to meet award Mandates Reform Act of 1995, 2 U.S.C. and Executive Orders 12866 and 13563: criteria dependent upon the size of the 1532, this final rule does not include Regulatory Planning and Review employer and the level of award the any Federal mandate that may result in Introduction sections of the preamble. employer is requesting, gold or excess of $100 million in expenditures As related to this rulemaking, VETS platinum. The following table provides by State, local, and Tribal governments submitted the final ICR, containing the the corresponding regulatory citation for in the aggregate or by the private sector. full analysis and description of the each award type. In addition, employers burden hours and costs associated with must maintain documentation of the Executive Order 13132 (Federalism) the final rule, to OMB on the date of information relied upon to complete the VETS has reviewed this final rule in publication for approval. A copy of this application for 2 years after the accordance with Executive Order 13132 ICR is available at https:// application is submitted to VETS regarding federalism and has www.reginfo.gov/public/do/ (§ 1011.600). determined that it does not have PRAOMBHistory?ombControl ‘‘federalism implications.’’ This rule Number=1293-0015 (this link will FINAL REGULATORY PROVISION will not ‘‘have substantial direct effects become active on the day following on the States, on the relationship Employer Platinum publication of the final rule). This size Gold award award between the national government and request also seeks authority for VETS to the States, or on the distribution of engage in a demonstration of the Large ...... § 1011.100(a) § 1011.100(b) power and responsibilities among the information collection and award in Medium ..... § 1011.105(a) § 1011.105(b) various levels of government.’’
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Executive Order 13084 (Consultation to minimize litigation, and written to 1011.405 What are the restrictions on and Coordination With Indian Tribal provide a clear legal standard for display and use of the HIRE Vets Governments) affected conduct and to promote burden Medallion Award? This final rule does not have Tribal reduction. Subpart F—Requests for Reconsideration implications under Executive Order List of Subjects in 20 CFR Part 1011 1011.500 What is the process to request 13175 that require a Tribal summary reconsideration of a denial or impact statement. The final rule does Employment, Veterans, Employer revocation? not have substantial direct effects on Recognition, Medallion. Subpart G—Record Retention one or more Indian Tribes, on the ■ For the reasons set out in the 1011.600 What are the record retention relationship between the Federal preamble, the Veterans’ Employment requirements for the HIRE Vets Government and Indian Tribes, or on and Training Service amends 20 CFR Medallion Award? the distribution of power and chapter IX by adding part 1011 to read Authority: Division O, Pub. L. 115–31, 131 responsibilities between the Federal as follows: Stat. 135. Government and Indian Tribes. PART 1011—HIRE VETS MEDALLION Subpart A—General Provisions Plain Language PROGRAM The final rule uses plain language. § 1011.000 What is the HIRE Vets Subpart A—General Provisions Medallion Program? Effects on Families Sec. The HIRE Vets Medallion Program is The undersigned hereby certifies that 1011.000 What is the HIRE Vets Medallion a voluntary employer recognition the final rule would not adversely affect Program? program administered by the the well-being of families. 1011.005 What definitions apply to this Department of Labor’s Veterans’ part? Employment and Training Service. Executive Order 13045 (Protection of 1011.010 Who is eligible to apply for a Through the HIRE Vets Medallion Children) HIRE Vets Medallion Award? Program, the Department of Labor This final rule would have no 1011.015 What are the different types of the solicits voluntary applications from HIRE Vets Medallion Awards? environmental health risk or safety risk employers for the HIRE Vets Medallion that may disproportionately affect Subpart B—Award Criteria Award. The purpose of this award is to children. 1011.100 What are the criteria for the large recognize efforts by applicants to employer HIRE Vets Medallion Award? recruit, employ, and retain veterans and Environmental Impact Assessment 1011.105 What are the criteria for the to provide services supporting the A review of this final rule in medium employer HIRE Vets Medallion veteran community. accordance with the requirements of the Award? National Environmental Policy Act of 1011.110 What are the criteria for the small § 1011.005 What definitions apply to this 1969 (NEPA), 42 U.S.C. 4321 et seq.; the employer HIRE Vets Medallion Award? part? 1011.115 Is there an exemption for certain regulations of the Council on Active Duty in the United States large employers from the dedicated National Guard or Reserve means active Environmental Quality, 40 CFR part human resources professional criterion 1500 et seq.; and DOL NEPA duty as defined in 10 U.S.C. 101(d)(1). for the large employer platinum HIRE Dedicated human resources procedures, 29 CFR part 11, indicates Vets Medallion Award? the final rule would not have a 1011.120 Under what circumstances will professional means either a full-time significant impact on the quality of the VETS find an employer ineligible to professional or the equivalent of a full- human environment. There is, thus, no receive a HIRE Vets Medallion Award for time professional dedicated exclusively corresponding environmental a violation of labor law? to supporting the hiring, training, and assessment or an environmental impact Subpart C—Application Process retention of veteran employees. Two statement. half-time professionals, for example, are 1011.200 How will VETS administer the equivalent to one full-time professional. Executive Order 13211 (Energy Supply) HIRE Vets Medallion Award process? Employee means any individual for 1011.205 What is the timing of the HIRE This final rule is not subject to Vets Medallion Award process? whom the employer furnishes an IRS Executive Order 13211. It will not have 1011.210 How often can an employer Form W–2, excluding temporary a significant adverse effect on the receive the HIRE Vets Medallion Award? workers. supply, distribution, or use of energy. 1011.215 How will the employer complete Employer means any person, the application for the HIRE Vets institution, organization, or other entity Executive Order 12630 Medallion Award? that pays salary or wages for work (Constitutionally Protected Property) 1011.220 How will VETS verify a HIRE Vets performed or that has control over This final rule is not subject to Medallion Award application? employee opportunities, except for the Executive Order 12630 because it does 1011.225 Under what circumstances will Federal Government or any State or VETS conduct further review of an foreign government. For the purposes of not involve implementation of a policy application? that has takings implications or that 1011.230 Under what circumstances can this regulation, VETS will recognize could impose limitations on private VETS deny or revoke an award? employers based on the Employer property use. Identification Number, as described in Subpart D—Fees and Caps 26 CFR 301.7701–12, used to furnish an Executive Order 12988 (Civil Justice 1011.300 What are the application fees for IRS Form W–2 to an employee. Reform Analysis) the HIRE Vets Medallion Award? However, in the case of an agent This final rule was drafted and 1011.305 May VETS set a limit on how designated pursuant to 26 CFR 31.3504– reviewed in accordance with Executive many applications will be accepted in a 1, a payor designated pursuant to 26 year? Order 12988 and will not unduly CFR 31.3504–2, or a Certified burden the Federal court system. The Subpart E—Design and Display Professional Employer Organization final rule was reviewed to eliminate 1011.400 What does a successful applicant recognized pursuant to 26 U.S.C. 7705, drafting errors and ambiguities, written receive? the employer shall be the common law
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employer, client, or customer, (3) Veterans constitute not less than 7 § 1011.105 What are the criteria for the respectively, instead of the entity that percent of all employees hired by such medium employer HIRE Vets Medallion furnishes the IRS Form W–2. employer during the prior calendar year; Award? Human Resources Veterans’ Initiative (4) The employer has retained not less (a) Gold Award. To qualify for a means an initiative through which an than 75 percent of the veteran medium employer gold HIRE Vets employer provides support for hiring, employees hired during the calendar Medallion Award, an employer must training, and retention of veteran year preceding the preceding calendar satisfy all of the following criteria: (1) The employer is a medium employees. year for a period of at least 12 months Post-secondary education means post- employer per § 1011.015 of this part; from the date on which the employees (2) The employer is not found secondary level education or training were hired; courses that would be acceptable for ineligible under § 1011.120 of this part; (5) The employer has established an (3) The employer has achieved at least credit toward at least one of the employee veteran organization or one of the following: following: associate’s or bachelor’s resource group to assist new veteran (i) Veterans constitute not less than 7 degree or higher, any other recognized employees with integration, including percent of all employees hired by such post-secondary credential, or an coaching and mentoring; and employer during the prior calendar year; apprenticeship. (6) The employer has established or Salary means an employee’s base pay. programs to enhance the leadership (ii) The employer has achieved both Temporary worker means any worker skills of veteran employees during their of the following: hired with the intention that the worker employment. (A) The employer has retained not be retained for less than 1 year and who less than 75 percent of the veteran (b) Platinum Award. To qualify for a is actually retained for less than 1 year. employees hired during the calendar large employer platinum HIRE Vets Veteran has the meaning given such year preceding the preceding calendar Medallion Award, an employer must term under 38 U.S.C. 101. year for a period of at least 12 months satisfy all of the following criteria: VETS means the Veterans’ from the date on which the employees Employment and Training Service of the (1) The employer is a large employer were hired; and Department of Labor. as specified in § 1011.015 of this part; (B) On December 31 of the year prior (2) The employer is not found to the year in which the employer § 1011.010 Who is eligible to apply for a ineligible under § 1011.120 of this part; applies for the HIRE Vets Medallion HIRE Vets Medallion Award? (3) Veterans constitute not less than Award, at least 7 percent of the All employers who employ at least 10 percent of all employees hired by employer’s employees were veterans; one employee are eligible to apply for a such employer during the prior calendar and HIRE Vets Medallion Award. To qualify year; (4) The employer has at least one of for a HIRE Vets Medallion Award, an (4) The employer has retained not less the following forms of integration employer must satisfy all application than 85 percent of the veteran assistance: requirements. employees hired during the calendar (i) The employer has established an employee veteran organization or § 1011.015 What are the different types of year preceding the preceding calendar resource group to assist new veteran the HIRE Vets Medallion Awards? year for a period of at least 12 months employees with integration, including (a) There are three different categories from the date on which the employees were hired; coaching and mentoring; or of the HIRE Vets Medallion Award: (ii) The employer has established (1) Large Employer Awards for (5) The employer has established an programs to enhance the leadership employers with 500 or more employees. employee veteran organization or skills of veteran employees during their (2) Medium Employer Awards for resource group to assist new veteran employment. employers with more than 50 but fewer employees with integration, including (b) Platinum Award. To qualify for a than 500 employees. coaching and mentoring; medium employer platinum HIRE Vets (3) Small Employer Awards for (6) The employer has established Medallion Award, an employer must employers with 50 or fewer employees. programs to enhance the leadership satisfy all of the following criteria: (4) Timing. The correct category of skills of veteran employees during their (1) The employer is a medium award is determined by the employer’s employment; employer as specified in § 1011.015 of number of employees as of December 31 (7) The employer employs a dedicated this part; of the year prior to the year in which the human resources professional as (2) The employer is not found employer applies for an award. defined in § 1011.005 of this part to ineligible under § 1011.120 of this part; (b) Within each award category, there support hiring, training, and retention of (3) The employer has achieved at least are two levels of award: veteran employees; one of the following: (i) Veterans constitute not less than 10 (1) A Gold Award; and (8) The employer provides each of its (2) A Platinum Award. percent of all employees hired by such employees serving on active duty in the employer during the prior calendar year; Subpart B—Award Criteria United States National Guard or Reserve or with compensation sufficient, in (ii) The employer has achieved both § 1011.100 What are the criteria for the combination with the employee’s active of the following: large employer HIRE Vets Medallion Award? duty pay, to achieve a combined level (A) The employer has retained not (a) Gold Award. To qualify for a large of income commensurate with the less than 85 percent of the veteran employer gold HIRE Vets Medallion employee’s salary prior to undertaking employees hired during the calendar Award, an employer must satisfy all of active duty; and year preceding the preceding calendar the following criteria: (9) The employer has a tuition year for a period of at least 12 months (1) The employer is a large employer assistance program to support veteran from the date on which the employees as specified in § 1011.015 of this part; employees’ attendance in post- were hired; and (2) The employer is not found secondary education during the term of (B) On December 31 of the year prior ineligible under § 1011.120 of this part; their employment. to the year in which the employer
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applies for the HIRE Vets Medallion (1) The employer is a small employer supporting the hiring, training, and Award, at least 10 percent of the as specified in § 1011.015 of this part; retention of veteran employees. employer’s employees were veterans; (2) The employer is not found (4) The employer has the following ineligible under § 1011.120 of this part; § 1011.120 Under what circumstances will VETS find an employer ineligible to receive forms of integration assistance: (3) The employer has achieved at least (i) The employer has established an a HIRE Vets Medallion Award for a violation one of the following: of labor law? employee veteran organization or (i) Veterans constitute not less than 10 (a) Any employer with an adverse resource group to assist new veteran percent of all employees hired by such labor law decision, stipulated employees with integration, including employer during the prior calendar year; agreement, contract debarment, or coaching and mentoring; and or (ii) The employer has established (ii) The employer has achieved both contract termination, as defined in programs to enhance the leadership of the following: paragraphs (b) through (e) of this skills of veteran employees during their (A) The employer has retained not section, pursuant to either of the employment; and less than 85 percent of the veteran following labor laws, as amended, will (5) The employer has at least one of employees hired during the calendar not be eligible to receive an award: (1) Uniformed Services Employment the following additional forms of year preceding the preceding calendar and Reemployment Rights Act integration assistance: year for a period of at least 12 months (USERRA); or (i) The employer has established a from the date on which the employees (2) Vietnam Era Veterans’ human resources veterans’ initiative; were hired; and (ii) The employer provides each of its Readjustment Assistance Act (B) On December 31 of the year prior employees serving on active duty in the (VEVRAA); to the year in which the employer United States National Guard or Reserve (b) For purposes of this section, an applies for the HIRE Vets Medallion with compensation sufficient, in adverse labor law decision means any of Award, at least 10 percent of the combination with the employee’s active the following, issued in the calendar employer’s employees were veterans; duty pay, to achieve a combined level year prior to year in which applications and are solicited or the calendar year in of income commensurate with the (4) The employer has at least two of which applications are solicited up employee’s salary prior to undertaking the following forms of integration until the issuance of the award, in active duty; or assistance: (iii) The employer has a tuition which a violation of any of the laws in (i) The employer has established an assistance program to support veteran paragraph (a) of this section is found: employee veteran organization or employees’ attendance in post- (1) A civil or criminal judgment; resource group to assist new veteran secondary education during the term of (2) A final administrative merits employees with integration, including their employment. determination of an administrative coaching and mentoring; adjudicative board or commission; or (ii) The employer has established § 1011.110 What are the criteria for the (3) A decision of an administrative small employer HIRE Vets Medallion programs to enhance the leadership law judge or other administrative judge Award? skills of veteran employees during their that is not appealed and that becomes employment; (a) Gold Award. To qualify for a small the final agency action. employer gold HIRE Vets Medallion (iii) The employer has established a (c) For purposes of this section, a Award, an employer must satisfy all of human resources veterans’ initiative; stipulated agreement means any the following criteria: (iv) The employer provides each of its agreement (including a settlement (1) The employer is a small employer employees serving on active duty in the agreement, conciliation agreement, as specified in § 1011.015 of this part; United States National Guard or Reserve consent decree, or other similar (2) The employer is not found with compensation sufficient, in ineligible under § 1011.120 of this part; document) to which the employer is a combination with the employee’s active party, entered into in the calendar year and duty pay, to achieve a combined level (3) The employer has achieved at least prior to the year in which applications of income commensurate with the are solicited or the calendar year in one of the following: employee’s salary prior to undertaking (i) Veterans constitute not less than 7 which applications are solicited up active duty; until the issuance of the award, that percent of all employees hired by such (v) The employer has a tuition contains an admission that the employer employer during the prior calendar year; assistance program to support veteran violated either of the laws cited in or employees’ attendance in post- (ii) The employer has achieved both paragraph (a) of this section. secondary education during the term of (d) For purposes of this section, a of the following: their employment. (A) The employer has retained not contract debarment means any order or less than 75 percent of the veteran § 1011.115 Is there an exemption for voluntary agreement, pursuant to the employees hired during the calendar certain large employers from the dedicated laws listed in paragraph (a) of this year preceding the preceding calendar human resources professional criterion for section, that debars the employer from year for a period of at least 12 months the large employer platinum HIRE Vets receiving any future Federal contract. from the date on which the employees Medallion Award? Employers shall be ineligible for an were hired; and Yes. Large employers who employ award for the duration of time that the (B) On December 31 of the year prior 5,000 or fewer employees need not have contract debarment is in effect. to the year in which the employer a dedicated human resources (e) For purposes of this section, a applies for the HIRE Vets Medallion professional to support the hiring and contract termination means any order or Award, at least 7 percent of the retention of veteran employees. A large voluntary agreement, pursuant to the employer’s employees were veterans. employer with 5,000 or fewer laws listed in paragraph (a) of this (b) Platinum Award. To qualify for a employees can satisfy the criterion at section, that terminates an existing small employer platinum HIRE Vets § 1011.100(b)(7) by employing at least Federal contract prior to its completion. Medallion Award, an employer must one human resources professional Employers shall be ineligible for the satisfy all of the following criteria: whose regular work duties include award if this termination occurred in
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the calendar year prior to the year in (d) Review period—VETS will finish § 1011.220 How will VETS verify a HIRE which applications are solicited or the reviewing applications not later than Vets Medallion Award application? calendar year in which applications are August 31 of each calendar year for the VETS will verify all information solicited up until the issuance of the awards to be awarded in November of provided by an employer in its award. that calendar year. application to the extent that such (f) VETS may delay issuing an award (e) Selection of recipients—VETS will information is relevant in determining to an employer if, at the time the award select the employers to receive HIRE whether or not such employer meets the is to be issued, VETS has credible Vets Medallion Awards not later than criteria to receive a HIRE Vets information that a significant violation September 30 of each calendar year for Medallion Award or in determining the of one of the laws in paragraph (a) of the awards to be awarded in November appropriate level of HIRE Vets this section may have occurred that of that calendar year. Medallion Award for that employer to could lead to an employer being (f) Notice of awards and denials— receive. VETS will verify this disqualified pursuant to any of VETS will notify employers who will information by reviewing all paragraphs (b) through (e) of this receive HIRE Vets Medallion Awards information provided as part of the section. not later than October 11 of each application. calendar year for the awards to be Subpart C—Application Process awarded in November of that calendar § 1011.225 Under what circumstances will year. VETS will also notify applicants VETS conduct further review of an application? § 1011.200 How will VETS administer the who will not be receiving an award at HIRE Vets Medallion Award process? that time. If at any time VETS becomes aware of The Secretary of Labor will facts that indicate that the information annually— § 1011.210 How often can an employer provided by an employer in its (a) Solicit and accept voluntary receive the HIRE Vets Medallion Award? application was incorrect or that the applications from employers in order to Per section 2(d) of the HIRE Vets Act, employer does not satisfy the consider whether those employers an employer who receives a HIRE Vets requirements at § 1011.120, VETS may should receive a HIRE Vets Medallion Medallion Award for 1 calendar year is conduct further review of the Award; not eligible to receive a HIRE Vets application. As part of that review, (b) Review applications received in Medallion Award for the subsequent VETS may request information and/or each calendar year; calendar year. documentation to confirm the accuracy (c) Notify such recipients of their of the information provided by the awards; and § 1011.215 How will the employer employer in its application or to (d) At a time to coincide with the complete the application for the HIRE Vets Medallion Award? confirm that the employer is not annual commemoration of Veterans ineligible under § 1011.120. Depending (a) VETS will require all applicants to Day— on the result of the review, VETS may provide information to establish their (1) Announce the names of such either deny or revoke the award. If eligibility for the HIRE Vets Medallion recipients; VETS initiates such review prior to Award. (2) Recognize such recipients through issuing the award, VETS will not be publication in the Federal Register; and (b) VETS may request additional information in support of the required to meet the timeline (3) Issue to each such recipient— requirements in this part. (i) A HIRE Vets Medallion Award; and application for the HIRE Vets Medallion (ii) A certificate stating that such Award. § 1011.230 Under what circumstances can employer is entitled to display such (c) The chief executive officer, the VETS deny or revoke an award? HIRE Vets Medallion Award. chief human resources officer, or an (a) Denial of award. VETS may deny equivalent official of each employer an award for any of the following § 1011.205 What is the timing of the HIRE applicant must attest under penalty of reasons: Vets Medallion Award process? perjury that the information the (1) The applicant fails to provide VETS will review all timely employer has submitted in its information and/or documentation as applications that fall under any cap application is accurate. requested under § 1011.225 of this part; established in § 1011.305 of this part to (d) Interested employers can access (2) VETS determines that the chief determine whether an employer should the application form via the HIRE Vets executive officer, the chief human receive a HIRE Vets Medallion Award, Web site accessible from https:// resources officer, or an equivalent and, if so, of what level. www.hirevets.gov/. official of the applicant falsely attested (a) Performance period—except as (e) Applicants will complete the that the information on the application otherwise noted in § 1011.120 of this application form and submit it was true; part, only the employer’s actions taken electronically. (3) The employer is ineligible to prior to December 31 of the calendar (f) Applicants who need a reasonable receive an award pursuant to § 1011.120 year prior to the calendar year in which accommodation in accessing the of this part; or applications are solicited will be application form, submitting the (4) The application does not satisfy all considered in reviewing the award. application form, or submitting the application requirements. (b) Solicitation period—VETS will application fee may contact VETS at (b) Revocation of award. Once the solicit applications not later than (202) 693–4700 or TTY (877) 889–5627 HIRE Vets Medallion Award has been January 31 of each calendar year for the (these are not toll-free numbers). awarded, VETS may revoke the HIRE Vets Medallion Award to be (g) Should the information provided recipient’s award for the following awarded in November of that calendar on the application be deemed reasons: year. incomplete, VETS will attempt to (1) The HIRE Vets Medallion Award (c) End of acceptance period—VETS contact the applicant. The applicant recipient fails to provide information will stop accepting applications on must respond with the additional and/or documentation as requested April 30 of each calendar year for the information necessary to complete the under § 1011.225 of this part; awards to be awarded in November of application form within 5 business days (2) VETS determines that the chief that calendar year. or VETS will deny the application. executive officer, the chief human
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resources officer, or an equivalent Subpart E—Design and Display receipt of any additional evidence or official of the recipient falsely attested explanation requested, VETS will issue that the information on the application § 1011.400 What does a successful a determination about whether to grant was true; applicant receive? or deny the request. (3) The employer was ineligible to (a) The award will be in the form of (e) No additional Department of Labor receive an award pursuant to § 1011.120 a certificate and will state the year for review is available. of this part; or which it was awarded. (4) The employer violated the display (b) VETS will also provide a digital Subpart G—Record Retention restrictions at § 1011.405 of this part. image of the medallion for recipients to § 1011.600 What are the record retention (c) If VETS decides to deny or revoke use, including as part of an advertisement, solicitation, business requirements for the HIRE Vets Medallion an award, it will provide the employer Award? with notice of the decision. An activity, or product. Applicants must retain a record of all employer may request reconsideration § 1011.405 What are the restrictions on information used to support an of VETS’ decision to deny or revoke an display and use of the HIRE Vets Medallion application for the HIRE Vets Medallion award pursuant to § 1011.500 of this Award? Award for 2 years from the date of part. It is unlawful for any employer to application. publicly display a HIRE Vets Medallion Subpart D—Fees and Caps Signed at Washington, DC, this 1st day of Award, in connection with, or as a part November 2017. § 1011.300 What are the application fees of, any advertisement, solicitation, J.S. Shellenberger, for the HIRE Vets Medallion Award? business activity, or product— (a) For the purpose of conveying, or Deputy Assistant Secretary for the Veterans’ (a) The Act requires the Secretary of Employment and Training Service. Labor to establish a fee sufficient to in a manner reasonably calculated to [FR Doc. 2017–24214 Filed 11–9–17; 8:45 am] cover the costs associated with carrying convey, a false impression that the out the HIRE Vets Medallion Program. employer received the award through BILLING CODE 4510–79–P (b) Table 1 to § 1011.300 sets forth the the HIRE Vets Medallion Program, if fees an employer must pay to apply for such employer did not receive such the HIRE Vets Medallion Award. VETS award through the HIRE Vets Medallion DEPARTMENT OF HEALTH AND will adjust the fees periodically Program; or HUMAN SERVICES according to the Implicit Price Deflator (b) For the purpose of conveying, or Food and Drug Administration for Gross Domestic Product published in a manner reasonably calculated to by the U.S. Department of Commerce convey, a false impression that the 21 CFR Part 573 and notify potential applicants of the employer received the award through adjusted fees. the HIRE Vets Medallion Program for a [Docket No. FDA–2014–F–0988] (1) If a significant adjustment is year for which such employer did not needed to arrive at a new fee for any receive such award. Food Additives Permitted in Feed and reason other than inflation, then a Drinking Water of Animals; Ammonium proposed rule containing the new fees Subpart F—Requests for Formate and Formic Acid will be published in the Federal Reconsideration AGENCY: Food and Drug Administration, Register for comment. § 1011.500 What is the process to request HHS. (2) VETS will round the fee to the reconsideration of a denial or revocation? ACTION: Final rule. nearest dollar. (a) An applicant may file a request for reconsideration of VETS’ decision to SUMMARY: The Food and Drug TABLE 1 TO § 1011.300 deny or revoke a HIRE Vets Medallion Administration (FDA, we, the Agency) Award or of VETS’ decision as to the is amending food additive regulations Application Fees level of award by mailing a request for for food additives permitted in feed and Small Employer Fee ...... $90.00 reconsideration to the following address drinking water of animals to provide for Medium Employer Fee ...... 190.00 no later than 15 business days after the the safe use of formic acid and Large Employer Fee ...... 495.00 date of VETS’ notice of its decision. ammonium formate. This action is in Requests for reconsideration must be response to a food additive petition filed (c) All applicants must submit the sent to: HIRE Vets Medallion Program, by BASF Corp for Feed Grade Sodium appropriate application processing fee DOL VETS, 200 Constitution Ave. NW., Formate (FAP 2286), which also for each application submitted. This fee Room S1325, Washington, DC 20210. proposed to amend the animal food is based on the fees provided in table 1 (b) Requests for reconsideration additive regulations for formic acid and to § 1011.300. Payment of this fee must pursuant to paragraph (a) of this section ammonium formate to limit formic acid be made electronically through the U.S. must contain the following: and formate salts from all added Treasury pay.gov system or an (1) The employer name and sources. equivalent. identification number; (2) The reason for the request; and DATES: This rule is effective November (d) Once a fee is paid, it is 13, 2017. Submit either written or nonrefundable, even if the employer (3) An explanation, accompanied by any necessary documentation to support electronic objections and requests for a withdraws the application or does not hearing by December 13, 2017. See receive a HIRE Vets Medallion Award. that explanation, of why VETS’ decision was incorrect. section V of this document for § 1011.305 May VETS set a limit on how (c) VETS may request from the information on the filing of objections. many applications will be accepted in a employer filing such request any ADDRESSES: You may submit objections year? additional evidence or explanation it and requests for a hearing as follows. Yes, VETS may set a limit on how finds necessary for reconsideration. Please note that late, untimely filed many applications will be accepted in (d) Within 30 business days after the objections will not be considered. any given year. later of the receipt of the request or the Electronic objections must be submitted
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on or before December 13, 2017. The viewable at https://www.regulations.gov regulations for food additives permitted https://www.regulations.gov electronic or at the Dockets Management Staff in feed and drinking water of animals be filing system will accept objections until between 9 a.m. and 4 p.m., Monday amended to provide for the safe use of midnight Eastern Time at the end of through Friday. feed grade sodium formate as a feed December 13, 2017. Objections received • Confidential Submissions—To acidifying agent in complete swine by mail/hand delivery/courier (for submit an objection with confidential feeds. The notice of petition provided written/paper submissions) will be information that you do not wish to be for a 30-day comment period on the considered timely if they are made publicly available, submit your petitioner’s request for categorical postmarked or the delivery service objections only as a written/paper exclusion from preparing an acceptance receipt is on or before that submission. You should submit two environmental assessment or date. copies in total. One copy will include environmental impact statement. the information you claim to be In addition, the petition proposed that Electronic Submissions confidential with a heading or cover the animal food additive regulations for Submit electronic objections in the note that states ‘‘THIS DOCUMENT formic acid and ammonium formate be following way: CONTAINS CONFIDENTIAL amended to limit formic acid and • Federal eRulemaking Portal: INFORMATION.’’ The Agency will formate salts from all added sources to https://www.regulations.gov. Follow the review this copy, including the claimed 1.2 percent of complete feeds. This instructions for submitting objections. confidential information, in its element of the petition was not Objections submitted electronically, consideration of objections. The second described in the July 2014 notice of including attachments, to https:// copy, which will have the claimed petition for FAP 2286, but was later www.regulations.gov will be posted to confidential information redacted/ described in a September 30, 2016, the docket unchanged. Because your blacked out, will be available for public notice of petition (81 FR 67260). objection will be made public, you are viewing and posted on https:// II. Conclusion solely responsible for ensuring that your www.regulations.gov. Submit both objection does not include any copies to the Dockets Management Staff. FDA became concerned about the confidential information that you or a If you do not wish your name and safety of higher levels of formic acid and third party may not wish to be posted, contact information to be made publicly formate salts in complete feeds when such as medical information, your or available, you can provide this multiple sources of formic acid and its anyone else’s Social Security number, or information on the cover sheet and not salts are used in combination. FDA confidential business information, such in the body of your objections and you concludes that the data establish the as a manufacturing process. Please note must identify this information as safety of formic acid and ammonium that if you include your name, contact ‘‘confidential.’’ Any information marked formate for use as a feed acidifying information, or other information that as ‘‘confidential’’ will not be disclosed agent in complete feeds, that formic acid identifies you in the body of your except in accordance with 21 CFR 10.20 and formate salts should be limited to objection, that information will be and other applicable disclosure law. For 1.2 percent on complete feed, and that posted on https://www.regulations.gov. the food additive regulations should be • more information about FDA’s posting If you want to submit an objection of comments to public dockets, see 80 amended as set forth in this document. with confidential information that you FR 56469, September 18, 2015, or access III. Public Disclosure do not wish to be made available to the the information at: https://www.gpo.gov/ public, submit the objection as a fdsys/pkg/FR-2015-09-18/pdf/2015- In accordance with § 571.1(h) (21 CFR written/paper submission and in the 23389.pdf. 571.1(h)), the petition and documents manner detailed (see ‘‘Written/Paper Docket: For access to the docket to we considered and relied upon in Submissions’’ and ‘‘Instructions’’). read background documents or the reaching our decision to approve the petition will be made available for Written/Paper Submissions electronic and written/paper objections received, go to https:// public disclosure (see FOR FURTHER Submit written/paper submissions as www.regulations.gov and insert the INFORMATION CONTACT). As provided in follows: § 571.1(h), we will delete from the • Mail/Hand delivery/Courier (for docket number, found in brackets in the heading of this document, into the documents any materials that are not written/paper submissions): Dockets available for public disclosure. Management Staff (HFA–305), Food and ‘‘Search’’ box and follow the prompts Drug Administration, 5630 Fishers and/or go to the Dockets Management IV. Analysis of Environmental Impact Lane, Rm. 1061, Rockville, MD 20852. Staff, 5630 Fishers Lane, Rm. 1061, The Agency has determined under 21 • For written/paper objections Rockville, MD 20852. CFR 25.32(r) that this action is of a type submitted to the Dockets Management FOR FURTHER INFORMATION CONTACT: that does not individually or Staff, FDA will post your objection, as Chelsea Trull, Center for Veterinary cumulatively have a significant effect on well as any attachments, except for Medicine, Food and Drug the human environment. Therefore, information submitted, marked and Administration, 7519 Standish Pl., neither an environmental assessment, identified, as confidential, if submitted Rockville, MD 20855, 240–402–6729, nor an environmental impact statement as detailed in ‘‘Instructions.’’ [email protected]. is required. Instructions: All submissions received SUPPLEMENTARY INFORMATION: must include the Docket No. FDA– V. Objections and Hearing Requests 2014–F–0988 for ‘‘Food Additives I. Background Any person who will be adversely Permitted in Feed and Drinking Water In a document published in the affected by this regulation may file with of Animals; Ammonium Formate and Federal Register of July 25, 2014 (79 FR the Dockets Management Staff (see Formic Acid.’’ Received objections, 43325), FDA announced that we had ADDRESSES) either electronic or written those filed in a timely manner (see filed a food additive petition (animal objections. Each objection shall be ADDRESSES), will be placed in the docket use) (FAP 2286) submitted by BASF separately numbered, and each and, except for those submitted as Corp., 100 Park Ave., Florham Park, NJ numbered objection shall specify with ‘‘Confidential Submissions,’’ publicly 07932. The petition proposed that the particularity the provision of the
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regulation to which objection is made required by the Federal Food, Drug, and FOR FURTHER INFORMATION CONTACT: The and the grounds for the objection. Each Cosmetic Act and paragraph (d) of this Department of the Treasury’s Office of numbered objection on which a hearing section, the label and labeling shall Foreign Assets Control: Assistant is requested shall specifically so state. contain: Director for Licensing, tel.: 202/622– Failure to request a hearing for any * * * * * 2480, Assistant Director for Regulatory particular objection shall constitute a ■ 3. In § 573.480, redesignate Affairs, tel.: 202/622–4855, Assistant waiver of the right to a hearing on that paragraphs (b)(3) and (4) as paragraphs Director for Sanctions Compliance & objection. Each numbered objection for (b)(4) and (5), add new paragraph (b)(3) Evaluation, tel.: 202/622–2490, or the which a hearing is requested shall and paragraph (b)(4)(iii) to newly Department of the Treasury’s Office of the Chief Counsel (Foreign Assets include a detailed description and redesignated paragraph (b)(4), and Control), Office of the General Counsel, analysis of the specific factual revise newly redesignated paragraph tel.: 202/622–2410. information intended to be presented in (b)(5) introductory text to read as support of the objection in the event follows: SUPPLEMENTARY INFORMATION: that a hearing is held. Failure to include Electronic and Facsimile Availability such a description and analysis for any § 573.480 Formic acid. particular objection shall constitute a * * * * * This document and additional waiver of the right to a hearing on the (b) * * * information concerning OFAC are objection. (3) To ensure safe use of the additive, available from OFAC’s Web site Any objections received in response formic acid and formate salts from all (www.treasury.gov/ofac). to the regulation may be seen in the added sources cannot exceed 1.2 Background office of the Dockets Management Staff percent of complete feed when multiple On February 7, 2006, the President between 9 a.m. and 4 p.m., Monday sources of formic acid and its salts are through Friday, and will be posted to issued Executive Order 13396, used in combination. ‘‘Blocking Property of Certain Persons the docket at https:// (4) * * * Contributing to the Conflict in Coˆte www.regulations.gov. (iii) Cautions for use including this d’Ivoire’’ (E.O. 13396), in which the statement: Caution: Follow label List of Subjects in 21 CFR Part 573 President declared a national emergency directions. Formic acid and formate Animal feeds, Food additives. to deal with the unusual and salts from all added sources cannot extraordinary threat to the national Therefore, under the Federal Food, exceed 1.2 percent of complete feed security and foreign policy of the United Drug, and Cosmetic Act and under when multiple sources of formic acid States posed by the situation in or in authority delegated to the Commissioner and its salts are used in combination. relation to Coˆte d’Ivoire. That situation, of Food and Drugs, 21 CFR part 573 is (5) To ensure safe use of the additive, which had been addressed by the amended as follows: in addition to the other information United Nations Security Council in required by the Federal Food, Drug, and PART 573—FOOD ADDITIVES Resolution 1572 of November 15, 2004, Cosmetic Act and paragraph (b)(4) of and subsequent resolutions, had PERMITTED IN FEED AND DRINKING this section, the label and labeling shall WATER OF ANIMALS resulted in the massacre of large contain: numbers of civilians, widespread ■ 1. The authority citation for part 573 * * * * * human rights abuses, significant continues to read as follows: Dated: November 3, 2017. political violence and unrest, and attacks against international Authority: 21 U.S.C. 321, 342, 348. Anna K. Abram, peacekeeping forces leading to fatalities. ■ Deputy Commissioner for Policy, Planning, 2. In § 573.170, redesignate Legislation, and Analysis. E.O. 13396 blocked all property and paragraphs (c) and (d) as paragraphs (d) [FR Doc. 2017–24366 Filed 11–9–17; 8:45 am] interests in property of the persons and (e), add new paragraph (c) and listed in the Annex to E.O. 13396 and BILLING CODE 4164–01–P paragraph (d)(3) to newly redesignated any person determined to meet one or paragraph (d), and revise newly more of the criteria set out in E.O. redesignated paragraph (e) introductory 13396. text to read as follows: DEPARTMENT OF THE TREASURY On April 13, 2009, OFAC issued the Office of Foreign Assets Control Persons Contributing to the Conflict in § 573.170 Ammonium formate. Coˆte d’Ivoire Sanctions Regulations, 31 * * * * * 31 CFR Part 543 CFR part 543 (the ‘‘Regulations’’), as a (c) To ensure safe use of the additive, final rule to implement E.O. 13396 (74 formic acid and formate salts from all Removal of Coˆ te d’Ivoire Sanctions FR 16763, April 13, 2009). On July 21, added sources cannot exceed 1.2 Regulations 2009, OFAC issued an amendment to percent of complete feed when multiple the Regulations to change the heading of sources of formic acid and its salts are AGENCY: Office of Foreign Assets the Regulations to the Coˆte d’Ivoire used in combination. Control, Treasury. Sanctions Regulations (74 FR 35802, * * * * * ACTION: Final rule. July 21, 2009). OFAC also amended the (d) * * * Regulations on February 8, 2012, to add (3) Cautions for use including this SUMMARY: The Department of the a definition of a term used in the statement: Caution: Follow label Treasury’s Office of Foreign Assets Regulations (77 FR 6463, Feb. 8, 2012). directions. Formic acid and formate Control (OFAC) is removing from the On September 14, 2016, the President salts from all added sources cannot Code of Federal Regulations the Coˆte issued Executive Order 13739, exceed 1.2 percent of complete feed d’Ivoire Sanctions Regulations as a ‘‘Termination of Emergency With when multiple sources of formic acid result of the termination of the national Respect to the Situation in or in and its salts are used in combination. emergency on which the regulations Relation to Coˆte d’Ivoire’’ (E.O. 13739). (e) To ensure safe use of the additive, were based. In E.O. 13739, the President found that in addition to the other information DATES: Effective: November 13, 2017. the situation that gave rise to the
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declaration of a national emergency in 2016), OFAC amends 31 CFR chapter V clearance of 50 feet above mean high E.O. 13396 with respect to the situation as follows: water (MHW) in the closed position. in or in relation to Coˆte d’Ivoire had The current operating schedule is set been significantly altered by the PART 543—[REMOVED] out in 33 CFR 117.716. Under this temporary deviation, the bridge will be progress achieved in the stabilization of ■ Coˆte d’Ivoire, including the successful 1. Remove part 543. maintained in the closed-to-navigation conduct of the October 2015 Dated: November 7, 2017. position for six (6) separate four (4) day presidential election, progress on the John E. Smith, periods from 7 a.m. until 5 p.m. starting management of arms and related Director, Office of Foreign Assets Control. from December 15, 2017, through materiel, and the combatting of illicit [FR Doc. 2017–24521 Filed 11–9–17; 8:45 am] December 18, 2017; January 4, 2018, trafficking in natural resources. BILLING CODE 4810–AL–P through January 7, 2018; January 11, Accordingly, and in view of the removal 2018, through January 14, 2018; January of multilateral sanctions by the United 18, 2018, through January 21, 2018; January 25, 2018, through January 28, Nations Security Council in Resolution DEPARTMENT OF HOMELAND 2018; and February 1, 2018, through 2283, the President terminated the SECURITY national emergency and revoked E.O. February 4, 2018. The bridge will open 13396. Coast Guard on signal at all other times. Therefore, OFAC is removing the The Delaware River is used by a Regulations from the Code of Federal 33 CFR Part 117 variety of vessels including small Regulations. Pursuant to section 202 of commercial vessels, recreational vessels the National Emergencies Act (50 U.S.C. [Docket No. USCG–2017–0758] and tug and barge traffic. The Coast 1622) and section 1 of E.O. 13739, Guard has carefully coordinated the termination of the national emergency Drawbridge Operation Regulation; restrictions with waterway users in declared in E.O. 13396 shall not affect Delaware River, Tacony, PA, and publishing this temporary deviation. any action taken or proceeding pending Palmyra, NJ Vessels able to pass through the and not fully concluded or determined AGENCY: Coast Guard, DHS. bridge in the closed position may do so if at least 15 minutes notice is given. as of 8:00 a.m. eastern daylight time on ACTION: Notice of deviation from The bridge will not be able to open for September 14, 2016 (the effective date of drawbridge regulation. E.O. 13739), any action or proceeding emergencies and there is no immediate based on any act committed prior to the SUMMARY: The Coast Guard has issued a alternate route for vessels unable to pass effective date, or any rights or duties temporary deviation from the operating through the bridge in the closed that matured or penalties that were schedule that governs the SR 73 position. The Coast Guard will also incurred prior to the effective date. (Tacony-Palmyra) Bridge across the inform the users of the waterways Delaware River, mile 107.2, in between through our Local and Broadcast Notice Public Participation Tacony, PA, and Palmyra, NJ. The to Mariners of the change in operating Because the Regulations involve a deviation is necessary to facilitate schedule for the bridge so that vessel foreign affairs function, the provisions routine maintenance. This deviation operators can arrange their transits to of Executive Order 12866 and the allows the bridge to remain in the minimize any impact caused by this Administrative Procedure Act (5 U.S.C. closed-to-navigation position. temporary deviation. In accordance with 33 CFR 117.35(e), 553) requiring notice of proposed DATES: This deviation is effective from the drawbridge must return to its regular rulemaking, opportunity for public 7 a.m. on December 15, 2017, through operating schedule immediately at the participation, and delay in effective 5 p.m. on February 4, 2018. date, as well as the provisions of end of this effective period of this ADDRESSES: The docket for this Executive Order 13771, are temporary deviation. This deviation deviation, [USCG–2017–0758] is inapplicable. Because no notice of from the operating regulations is available at http://www.regulations.gov. proposed rulemaking is required for this authorized under 33 CFR 117.35. Type the docket number in the rule, the Regulatory Flexibility Act (5 ‘‘SEARCH’’ box and click ‘‘SEARCH’’. Dated: November 3, 2017. U.S.C. 601–612) does not apply. Click on Open Docket Folder on the line Hal R. Pitts, Paperwork Reduction Act associated with this deviation. Bridge Program Manager, Fifth Coast Guard District. The Paperwork Reduction Act does FOR FURTHER INFORMATION CONTACT: If [FR Doc. 2017–24468 Filed 11–9–17; 8:45 am] not apply because this rule does not you have questions on this temporary impose information collection deviation, call or email Mr. Mickey BILLING CODE 9110–04–P requirements that would require the Sanders, Bridge Administration Branch Fifth District, Coast Guard; telephone approval of the Office of Management DEPARTMENT OF HOMELAND (757) 398–6587, email and Budget under 44 U.S.C. 3501 et seq. SECURITY [email protected]. List of Subjects in 31 CFR Part 543 SUPPLEMENTARY INFORMATION: The Coast Guard Administrative practice and Burlington County Bridge Commission, procedure, Banks, Banking, Blocking of owner and operator of the SR 73 33 CFR Part 165 assets, Coˆte d’Ivoire, Credit, Foreign (Tacony-Palmyra) Bridge across the trade, Penalties, Reporting and Delaware River, mile 107.2, in between [Docket Number USCG–2017–0990] recordkeeping requirements, Securities, Tacony, PA, and Palmyra, NJ, has RIN 1625–AA00 Services. requested a temporary deviation from For reasons set forth in the preamble, the current operating schedule to Safety Zone; City of Oswego Fireworks and under the authority of 3 U.S.C. 301; accommodate annual maintenance to Display; Oswego River, Oswego, NY 50 U.S.C. 1601–1651; E.O. 13396, 71 FR replace machinery components for the AGENCY: Coast Guard, DHS. 7389, 3 CFR, 2006 Comp., p. 209; E.O. drive system that operates the bascule ACTION: Temporary final rule. 13739, 81 FR 63673 (September 16, spans. The bridge has a vertical
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SUMMARY: The Coast Guard is hazards associated with a fireworks Order 12866. Accordingly, this rule has establishing a temporary safety zone on display. not been reviewed by the Office of the Oswego River, Oswego, NY. This Under 5 U.S.C. 553(d)(3), the Coast Management and Budget. safety zone is intended to restrict Guard finds that good cause exists for We conclude that this rule is not a vessels from portions of the Oswego making this temporary rule effective less significant regulatory action because we River during the City of Oswego than 30 days after publication in the anticipate that it will have minimal fireworks display. This temporary safety Federal Register because doing so impact on the economy, will not zone is necessary to protect mariners would be impracticable and contrary to interfere with other agencies, will not and vessels from the navigational the public interest. Delaying the adversely alter the budget of any grant hazards associated with a fireworks effective date would be contrary to the or loan recipients, and will not raise any display. Entry of vessels or persons into rule’s objectives of ensuring safety of novel legal or policy issues. The safety this zone is prohibited unless life on the navigable waters and zone created by this rule will be specifically authorized by the Captain of protection of persons and vessels near relatively small and enforced for a the Port Buffalo. the event. relatively short time. Also, the safety DATES: zone is designed to minimize its impact This rule is effective from 7:15 III. Legal Authority and Need for Rule p.m. on November 25, 2017 until 8:15 on navigable waters. Furthermore, the p.m. on November 26, 2017. The Coast Guard is issuing this rule safety zone has been designed to allow ADDRESSES: To view documents under authority in 33 U.S.C. 1231. The vessels to transit around it. Thus, mentioned in this preamble as being Captain of the Port Buffalo (COTP) has restrictions on vessel movement within available in the docket, go to http:// determined that a fireworks display that particular area are expected to be www.regulations.gov, type USCG–2017– presents significant risks to public minimal. Under certain conditions, 0990 in the ‘‘SEARCH’’ box and click safety and property. Such hazards moreover, vessels may still transit ‘‘SEARCH.’’ Click on Open Docket include premature and accidental through the safety zone when permitted Folder on the line associated with this detonations, dangerous projectiles, and by the Captain of the Port. rule. falling or burning debris. This rule is B. Impact on Small Entities FOR FURTHER INFORMATION CONTACT: If needed to protect personnel, vessels, and the marine environment in the The Regulatory Flexibility Act of you have questions on this rule, call or 1980, 5 U.S.C. 601–612, as amended, email LT Michael Collet, Chief of navigable waters within the safety zone while the fireworks display takes place. requires Federal agencies to consider Waterways Management, U.S. Coast the potential impact of regulations on Guard Sector Buffalo; telephone 716– IV. Discussion of the Rule small entities during rulemaking. The 843–9322, email D09-SMB-SECBuffalo- This rule establishes a safety zone on term ‘‘small entities’’ comprises small [email protected]. November 25, 2017, or in the event of businesses, not-for-profit organizations SUPPLEMENTARY INFORMATION: inclement weather November 26, 2017, that are independently owned and I. Table of Abbreviations from 7:15 p.m. to 8:15 p.m. The safety operated and are not dominant in their zone will encompass all waters of the fields, and governmental jurisdictions CFR Code of Federal Regulations Oswego River; Oswego, NY contained with populations of less than 50,000. DHS Department of Homeland Security ° ′ ″ FR Federal Register within 210-foot radius of: 43 27 15.37 The Coast Guard certifies under 5 U.S.C. NPRM Notice of proposed rulemaking N., 076°30′28.34″ W. (NAD 83). 605(b) that this rule will not have a § Section Entry into, transiting, or anchoring significant economic impact on a U.S.C. United States Code within the safety zone is prohibited substantial number of small entities. unless authorized by the Captain of the While some owners or operators of II. Background Information and vessels intending to transit the safety Regulatory History Port Buffalo or his designated on-scene representative. The Captain of the Port zone may be small entities, for the The Coast Guard is issuing this or his designated on-scene reasons stated in section V.A above, this temporary rule without prior notice and representative may be contacted via rule will not have a significant opportunity to comment pursuant to VHF Channel 16. economic impact on any vessel owner authority under section 4(a) of the or operator. Administrative Procedure Act (APA) (5 V. Regulatory Analyses Under section 213(a) of the Small U.S.C. 553(b)). This provision We developed this rule after Business Regulatory Enforcement authorizes an agency to issue a rule considering numerous statutes and Fairness Act of 1996 (Pub. L. 104–121), without prior notice and opportunity to Executive Orders related to rulemaking. we want to assist small entities in comment when the agency for good Below we summarize our analyses understanding this rule. If the rule cause finds that those procedures are based on a number of these statutes and would affect your small business, ‘‘impracticable, unnecessary, or contrary Executive Orders, and we discuss First organization, or governmental to the public interest.’’ Under 5 U.S.C. Amendment rights of protestors. jurisdiction and you have questions 553(b)(B), the Coast Guard finds that concerning its provisions or options for good cause exists for not publishing a A. Regulatory Planning and Review compliance, please contact the person notice of proposed rulemaking (NPRM) Executive Orders 12866 and 13563 listed in the FOR FURTHER INFORMATION with respect to this rule because the direct agencies to assess the costs and CONTACT section. event sponsor did not submit notice to benefits of available regulatory Small businesses may send comments the Coast Guard with sufficient time alternatives and, if regulation is on the actions of Federal employees remaining before the event to publish an necessary, to select regulatory who enforce, or otherwise determine NPRM. Delaying the effective date of approaches that maximize net benefits. compliance with, Federal regulations to this rule to wait for a comment period Executive Order 13771 directs agencies the Small Business and Agriculture to run would be impracticable and to control regulatory costs through a Regulatory Enforcement Ombudsman contrary to the public interest by budgeting process. This rule has not and the Regional Small Business inhibiting the Coast Guard’s ability to been designated a ‘‘significant Regulatory Fairness Boards. The protect spectators and vessels from the regulatory action,’’ under Executive Ombudsman evaluates these actions
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annually and rates each agency’s complying with the National Captain of the Port Buffalo or his responsiveness to small business. If you Environmental Policy Act of 1969 (42 designated on-scene representative. wish to comment on actions by U.S.C. 4321–4370f), and have (2) This safety zone is closed to all employees of the Coast Guard, call 1– determined that this action is one of a vessel traffic, except as may be 888–REG–FAIR (1–888–734–3247). The category of actions that do not permitted by the Captain of the Port Coast Guard will not retaliate against individually or cumulatively have a Buffalo or his designated on-scene small entities that question or complain significant effect on the human representative. about this rule or any policy or action environment. This rule establishes a (3) The ‘‘on-scene representative’’ of of the Coast Guard. temporary safety zone. It is categorically the Captain of the Port Buffalo is any excluded under section 2.B.2, figure 2– Coast Guard commissioned, warrant or C. Collection of Information 1, paragraph 34(g) of the Instruction, petty officer who has been designated This rule will not call for a new which pertains to establishment of by the Captain of the Port Buffalo to act collection of information under the safety zones. A Record of Environmental on his behalf. Paperwork Reduction Act of 1995 (44 Consideration (REC) supporting this (4) Vessel operators desiring to enter U.S.C. 3501–3520). determination is available in the docket or operate within the safety zone must D. Federalism and Indian Tribal where indicated in the ADDRESSES contact the Captain of the Port Buffalo Governments section of this preamble. or his on-scene representative to obtain permission to do so. The Captain of the G. Protest Activities A rule has implications for federalism Port Buffalo or his on-scene under Executive Order 13132, The Coast Guard respects the First representative may be contacted via Federalism, if it has a substantial direct Amendment rights of protesters. VHF Channel 16. Vessel operators given effect on the States, on the relationship Protesters are asked to contact the permission to enter or operate in the between the national government and person listed in the FOR FURTHER safety zone must comply with all the States, or on the distribution of INFORMATION CONTACT section to directions given to them by the Captain power and responsibilities among the coordinate protest activities so that your of the Port Buffalo, or his on-scene various levels of government. We have message can be received without representative. analyzed this rule under that Order and jeopardizing the safety or security of Dated: November 6, 2017. have determined that it is consistent people, places, or vessels. with the fundamental federalism J.S. Dufresne, principles and preemption requirements List of Subjects in 33 CFR Part 165 Captain, U.S. Coast Guard, Captain of the described in Executive Order 13132. Harbors, Marine safety, Navigation Port Buffalo. Also, this rule does not have tribal (water), Reporting and recordkeeping [FR Doc. 2017–24498 Filed 11–9–17; 8:45 am] implications under Executive Order requirements, Security measures, BILLING CODE 9110–04–P 13175, Consultation and Coordination Waterways. with Indian Tribal Governments, For the reasons discussed in the DEPARTMENT OF HOMELAND because it does not have a substantial preamble, the Coast Guard amends 33 SECURITY direct effect on one or more Indian CFR part 165 as follows: tribes, on the relationship between the Federal Government and Indian tribes, PART 165—REGULATED NAVIGATION Coast Guard or on the distribution of power and AREAS AND LIMITED ACCESS AREAS responsibilities between the Federal 33 CFR Part 165 ■ 1. The authority citation for part 165 Government and Indian tribes. If you [Docket Number USCG–2017–1011] believe this rule has implications for continues to read as follows: federalism or Indian tribes, please Authority: 33 U.S.C. 1231; 50 U.S.C. 191; RIN 1625–AA00 contact the person listed in the FOR 33 CFR 1.05–1, 6.04–1, 6.04–6, and 160.5; FURTHER INFORMATION CONTACT section Department of Homeland Security Delegation Safety Zone, Delaware River; Pipeline above. No. 0170.1. Removal ■ E. Unfunded Mandates Reform Act 2. Add § 165.T09–0990 to read as AGENCY: Coast Guard, DHS. follows: The Unfunded Mandates Reform Act ACTION: Temporary final rule; correcting of 1995 (2 U.S.C. 1531–1538) requires § 165.T09–0990 Safety Zone; City of amendment. Federal agencies to assess the effects of Oswego Fireworks Display; Oswego River, their discretionary regulatory actions. In Oswego, NY. SUMMARY: The Coast Guard is correcting particular, the Act addresses actions (a) Location. The safety zone will a temporary final rule that appeared in that may result in the expenditure by a encompass all waters of the Oswego the Federal Register on November 6, State, local, or tribal government, in the River; Oswego, NY contained within a 2017. The document issued a temporary aggregate, or by the private sector of 210-foot radius of: 43°27′15.37″ N., safety zone for in the Mifflin Range on $100,000,000 (adjusted for inflation) or 076°30′28.34″ W. (NAD 83). the Delaware River to facilitate pipeline more in any one year. Though this rule (b) Enforcement period. This removal in preparation for the will not result in such expenditure, we regulation will be enforced from 7:15 deepening of the Delaware River. Due to do discuss the effects of this rule p.m. until 8:15 p.m. on November 25, mechanical issues on the SHELBY, the elsewhere in this preamble. 2017, or in the event of inclement dredging operations will be attended by weather, on November 26, 2017, from the towing vessel GRAPE APE for the F. Environment 7:15 p.m. until 8:15 p.m. duration of the safety zone. All vessel We have analyzed this rule under (c) Regulations. (1) In accordance with contact information remains the same. Department of Homeland Security the general regulations in § 165.23 of DATES: This correction is effective Management Directive 023–01 and this part, entry into, transiting, or without actual notice from November Commandant Instruction M16475.lD, anchoring within this safety zone is 13, 2017 until December 4, 2017. For the which guide the Coast Guard in prohibited unless authorized by the purpose of enforcement, actual notice
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will be used from November 6, 2017, number of the regulatory updates proposed changes could be until November 13, 2017. proposed in the notice of proposed implemented in the near future, without FOR FURTHER INFORMATION CONTACT: If rulemaking published on May 18, 2017. the new system. Thus, the Office noted you have questions on this rule, call or DATES: Effective December 18, 2017. that, to the extent possible under the email Petty Officer Edmund Ofalt, FOR FURTHER INFORMATION CONTACT: Office’s current paper system, the Office Waterways Management Branch, U.S. Sarang V. Damle, General Counsel and intended to adopt some aspects of the Coast Guard Sector Delaware bay; Associate Register of Copyrights, by proposed rule on an interim basis until telephone (215) 271–4814, email such time as the electronic system is email at [email protected], or Jason E. 5 [email protected]. Sloan, Attorney-Advisor, by email at complete and a final rule is enacted. SUPPLEMENTARY INFORMATION: In FR Doc. [email protected]. Each can be contacted by II. Interim Rule 2017–24068, appearing at 82 FR 51347 telephone by calling (202) 707–8350. As indicated in the NPRM, this on Monday, November 6, 2017, SUPPLEMENTARY INFORMATION: interim rule adopts those provisions § 165.T05–1011(c) incorrectly references I. Background described in the NPRM that the Office ‘‘SHELBY’’ instead of ‘‘GRAPE APE.’’ believes will help streamline the This document corrects that error. Under the Copyright Act of 1976, the recordation process prior to completion U.S. Copyright Office is responsible for List of Subjects in 33 CFR Part 165 of the new electronic recordation recording documents pertaining to system. Harbors, Marine safety, Navigation works under copyright, such as Unlike a typical interim rule, this one (water), Reporting and recordkeeping assignments, licenses, and grants of is being promulgated following a notice requirements, Security measures, security interests.1 The Office is also of proposed rulemaking and a period for Waterways. responsible for recording notices of public comment. In response to the For the reasons discussed in the termination.2 As discussed in a notice of NPRM, the Office received thirteen preamble, the Coast Guard corrects 33 proposed rulemaking published in the comments from a variety of CFR part 165 by making the following Federal Register on May 18, 2017 stakeholders.6 As this interim rule does correcting amendment: (‘‘NPRM’’),3 the current recordation not cover every issue raised by the process is a time-consuming and labor- NPRM or the commenters, the Office PART 165—REGULATED NAVIGATION intensive paper-based one, requiring reserves judgment on any matters not AREAS AND LIMITED ACCESS AREAS remitters to submit their documents in expressly discussed herein and no hard copy. inference should be drawn from the ■ 1. The authority citation for part 165 The Office is engaged in an effort to Office’s silence on any particular point. continues to read as follows: modernize the recordation process in Additionally, the Office reserves the Authority: 33 U.S.C. 1231; 50 U.S.C. 191; coming years by developing a fully right to issue other interim rules during 33 CFR 1.05–1, 6.04–1, 6.04–6, and 160.5; electronic, online system through which the course of developing the system. Department of Homeland Security Delegation remitters will be able to submit their The comments received in response to No. 0170.1. documents and all applicable indexing the NPRM not addressed by this interim § 165.T05–1011 [Corrected] information to the Office for rule will continue to be evaluated by the recordation. In conjunction with the Office as system development ■ 2. In § 165.T05–1011(c), remove anticipated development effort, the progresses. The Office intends to issue ‘‘SHELBY’’ wherever it appears and Office issued the NPRM to propose a final rule under this same rulemaking adding in its place ‘‘GRAPE APE’’. updates to the Office’s current docket in connection with the public Dated: November 6, 2017. regulations to govern the submission of release of the new system. Scott E. Anderson, documents to the Office for recordation While some discrete aspects of the Captain, U.S. Coast Guard, Captain of the once the new electronic system is proposed rule were opposed, most were Port, Delaware Bay. developed and launched. The NPRM either unopposed or affirmatively [FR Doc. 2017–24508 Filed 11–9–17; 8:45 am] explained that while the Office could supported. As such, except as otherwise BILLING CODE 9110–04–P not estimate when the new system discussed below, the proposed rule is would be completed, public comments being adopted largely for the reasons were being sought because the Office discussed in the NPRM.7 As stated in LIBRARY OF CONGRESS needed to make a number of policy the NPRM, the general mechanics of the decisions critical to the design of the to- new regulations are essentially the same U.S. Copyright Office be-developed system.4 as under the Office’s current rules and In addition, as most relevant here, the policies.8 To be eligible for recordation, 37 CFR Part 201 NPRM further stated that while the the document or notice of termination proposed amendments were designed must satisfy certain requirements, be [Docket No. 2017–7] with a new electronic submission system in mind, at least some of the 5 Id. at 22771–72. Modernizing Copyright Recordation 6 The commenters are Author Services, Inc., Authors Alliance, Copyright Alliance, CSC, Dale 1 AGENCY: U.S. Copyright Office, Library 17 U.S.C. 205. Adams, Entertainment Software Association of Congress. 2 A ‘‘notice of termination’’ is a notice that (‘‘ESA’’), Intellectual Property Owners Association, terminates a grant to a third party of a copyright in ACTION: Kernochan Center for Law, Media and the Arts Interim rule. a work or any rights under a copyright. Only certain (‘‘Kernochan’’), Motion Picture Association of grants may be terminated, and only in certain America, Inc. (‘‘MPAA’’), ‘‘Music Parties’’ (joint SUMMARY: The United States Copyright circumstances. Termination is governed by three comment by American Association of Independent Office is issuing an interim rule separate provisions of the Copyright Act, with the Music, Recording Industry Association of America, amending its regulations governing relevant one depending on a number of factors, Inc., and National Music Publishers’ Association), recordation of transfers of copyright including when the grant was made, who executed Music Reports, Inc. (‘‘MRI’’); Sergey Vernyuk, and it, and when copyright was originally secured for Software and Information Industry Association ownership, other documents pertaining the work. See 17 U.S.C. 203, 304(c), 304(d). (‘‘SIIA’’). to a copyright, and notices of 3 82 FR 22771 (May 18, 2017). 7 See generally 82 FR 22771. termination. The interim rule adopts a 4 Id. at 22771. 8 See id. at 22772, 22776.
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submitted properly, and be definition of ‘‘actual signature.’’ 12 The In connection with this proposal, the accompanied by the applicable fee. As Office proposed to continue requiring, Office explained that it disagreed with before, the date of recordation will be in accordance with section 205(a), that the suggestion from Professor Brauneis’s the date when all of the required to record a document, remitters must report, Transforming Document elements are received by the Office, and submit either the original document Recordation at the United States the Office may reject any document or ‘‘bear[ing] the actual signature of the Copyright Office, that the signature be in notice submitted for recordation that person who executed it’’ or a ‘‘true copy a ‘‘discrete and identifiable form’’ on the fails to comply with the statute or the of the original, signed document’’ remitted document.16 Instead, the Office Office’s rules or instructions. While accompanied by a ‘‘sworn or official proposed resolving in another way recordation of section 205 documents is certification.’’ In discussing the Professor Brauneis’s concern that having optional, pursuant to statute, notices of application of the statute to electronic too broad a definition could potentially termination must be recorded with the documents and electronic signatures, include ‘‘acts that do not generate a Office ‘‘as a condition to its taking the NPRM proposed that to avoid any trace that is easily remitted as ‘a effect.’’ 9 doubt about the sufficiency of a signature’ on ‘a document.’ ’’ 17 The recordation on the basis of whether or A. Transfers of Copyright Ownership Office proposed that rather than restrict not the submitted document is an the definition of signature, the rule and Other Documents Pertaining to a original or a copy, the Office would Copyright should require that where an actual consider any document either submitted signature is not a handwritten or Cover Sheet and Electronic Title Lists. electronically through the new system, typewritten name, such as when an As was proposed,10 the interim rule or lacking a handwritten, wet signature individual clicks a button on a Web site requires paper submissions to be (e.g., any document bearing an or application to indicate agreement to accompanied by a cover sheet that is electronic signature) to be a ‘‘copy’’ 13 contractual terms, the remitter should similar to the current Form DCS. In within the meaning of section 205. be required to submit evidence addition to the information currently The Office noted that, in practice, this demonstrating the existence of the collected, the new Form DCS asks for would be unlikely to significantly affect signature, such as by appending a remitters, as the only consequence is some minor additional indexing database entry or confirmation email to that each such submission would need information and has some additional a copy of the terms showing that a to be accompanied by a sworn or official checkboxes to help with the document particular user agreed to them by certification. As no commenter objected, examination process. Additionally, the clicking ‘‘yes’’ on a particular date.18 various required certifications discussed the Office is adopting this as part of the below can also be made using Form interim rule, to the extent applicable to To the extent discussed by DCS. Having all of this information in the current paper-based submission commenters, the Office’s proposal on 19 one place will benefit remitters by process. these issues was largely supported. aiding them in confirming that their The NPRM also proposed a definition One commenter, however, took issue submissions are complete and comply of the statutory term ‘‘actual with the Office’s proposal not to limit with the requirements for recordation. It signature.’’ 14 As discussed in the signatures to those in a ‘‘discrete and should also benefit the Office by making NPRM, that term has been undefined in identifiable form’’ on the remitted the examination process more efficient, the Office’s regulations, but in practice, document.20 That commenter stated that as examiners will no longer need to the Office has required original the text of sections 204 and 205 contain search through the document itself to documents to bear handwritten, wet materially different requirements and find this indexing information. signatures and copies of documents to that, while in section 204, Congress Also as proposed,11 remitters may reproduce such handwritten, wet adopted a more flexible writing continue to provide electronic lists of signatures. Electronic signatures have requirement that would ultimately be certain indexing information about the not been permitted. After analyzing the tested in an adversarial environment, in works to which the document pertains. issue, the Office concluded that its section 205, Congress was narrower to As the NPRM discussed, much of the regulations and processes should be create more certainty that if the current regulation’s details surrounding flexible enough to permit any document requirements are met one would receive the formatting of electronic title lists are that may constitute a transfer of the enumerated benefits of 21 being removed. Instead, the interim rule copyright ownership under section 204 recordation. The commenter states that such lists must be prepared of the Copyright Act to be recordable contended that the result of the and submitted in the manner specified under section 205. Thus, the Office proposed rule would be that the scope by the Office in instructions it will post proposed defining ‘‘actual signature’’ as of section 205 would be improperly on its Web site. This change will allow any legally binding signature, including the Office to develop more flexible an electronic signature as defined by the and merely refers to the E-Sign Act as an example 15 instructions for remitters that can be E-Sign Act. of something that would be included within that definition. The Office did not mean to imply that updated and modified as needed 12 Id. at 22772–74. the various requirements applicable to the E-Sign without resorting to a rulemaking. No Act were being imported into the Office’s new 13 Id. at 22772–73. definition of ‘‘actual signature.’’ commenter objected to this proposed 14 Id. at 22773. 16 82 FR at 22773 (quoting Robert Brauneis, change. 15 Id. The E-Sign Act defines ‘‘electronic Transforming Document Recordation at the U.S. Originals, Copies, and Actual signature’’ as ‘‘an electronic sound, symbol, or Copyright Office 66 (Dec. 2014), https:// Signatures. One of the more significant process, attached to or logically associated with a www.copyright.gov/docs/recordation/recordation- contract or other record and executed or adopted by report.pdf. [hereinafter Brauneis Report]). proposals the Office made in the NPRM a person with the intent to sign the record.’’ 15 17 82 FR at 22773 (quoting Brauneis Report at 66). dealt with the treatment of original U.S.C. 7006(5). While Copyright Alliance and 18 documents versus copies, and the MPAA supported this proposed definition, they Id. at 22773. asked that the Office not create any requirements 19 See Copyright Alliance Comments at 2; MPAA above and beyond what is required in the E-Sign Comments at 2; Music Parties Comments at 4; 9 17 U.S.C. 203(a)(4)(A), 304(c)(4)(A), 304(d)(1). Act. See Copyright Alliance Comments at 2; MPAA Sergey Vernyuk Comments. 10 82 FR at 22772. Comments at 2. The interim rule adopts the very 20 SIIA Comments at 2–5. 11 Id. broad definition of ‘‘any legally binding signature’’ 21 Id. at 4.
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subsumed by section 204 (and vice Certifications. Given the general lack the Office allow a single representative versa).22 of opposition to the proposed rule’s to make both sets of certifications.31 The Office disagrees. Section 204 various certification requirements, they That is exactly what the Office describes what is necessary for a are being adopted for the reasons intended. Where a single person is in a transfer of copyright ownership to be provided in the NPRM, except as noted position to make both the remitter- valid and section 205 states explicitly below.26 Thus, under the interim rule, related and document-related that ‘‘[a]ny transfer of copyright remitters are required to provide certifications, he or she can make them ownership . . . may be recorded.’’ 23 essentially two sets of certifications. all on the document cover sheet Thus, any transfer that is valid under First, the remitter must personally submitted with the document to the section 204 should be recordable under certify that he or she has appropriate Office. The Office’s rules permit section 205.24 As explained in the authority to submit the document for different people to make the two sets of NPRM, the recordation requirement of recordation and that the indexing and certifications simply to provide more an ‘‘actual signature’’ merely other information submitted to the flexibility to parties in the event, for distinguishes the signature on the Office by the remitter is true, accurate, example, the person filling out the original document from the and complete to the best of the document cover sheet and remitting the reproduction of that signature on a copy remitter’s knowledge. These remitter- document is not in a position to make of the document, and is not meant to related certifications concern the the document-related certifications (e.g., limit the type of signature a document remitter’s authority to make the if the remitter is a paralegal or an must have in order to be recorded.25 recordation and the veracity of the administrative assistant without Accordingly the Office’s interim rule indexing and other information knowledge of the underlying essentially adopts the approach set forth provided as a part of the submission; the document). Only in that case would two in the NPRM, including the definition of certifications do not pertain to the individuals be making the separate ‘‘actual signature’’ as proposed. The actual document being submitted for certifications. And even in that case, the interim rule provides that where a recordation. The remitter can make remitter would still sign the document signature is not a handwritten or these certifications by signing, either cover sheet for the remitter-related typewritten name, to be recordable, the electronically or by hand, the required certifications; the other individual remitter must provide a description of cover sheet. would make the document-related the nature of the signature and whatever Second, the interim rule requires certifications on a separate page of the evidence is necessary to demonstrate certifications related to the document cover sheet. the existence of the signature. At the itself: That the actual document being As to the Office’s proposed expansion same time, the Office recognizes that, in submitted for recordation conforms to of the categories of people who can 27 the case of signatures that are not the Office’s signature, completeness, make a sworn certification to include discrete and identifiable, it may prove legibility, and redaction rules and, any person having an interest in a difficult in practice for recordation where the document is a copy, that it be copyright to which the document accompanied by an official or sworn pertains, as well as such person’s examiners to determine on a case-by- 28 case basis whether a document has been certification. These document-related authorized representative, one actually signed. Thus, the Office will certifications generally can be made by commenter partially objected. The not evaluate the evidence submitted in either the remitter or another individual commenter agreed that successors-in- such cases, but will presume that the on the cover sheet submitted with the interest to the original parties and their document to the Office.29 An official representatives should be permitted, but signature requirement has been satisfied certification, however, would need to be took issue with permitting third-party and record the document (if all other attached separately. beneficiaries to make the certification, requirements for recordation have been While one commenter voiced voicing concerns of fraud and/or error met). The Office will also make any of concerns that having two sets of by those who mistakenly believe or the ancillary material submitted certifications that can be made by fraudulently represent themselves as available for public inspection. The different individuals could be confusing deriving some incidental benefit from a interim rule makes clear, however, that and burdensome,30 the Office believes document to be recorded.32 On further this presumption is without prejudice to the commenter may have reflection, the Office believes that any party claiming that the document misunderstood the Office’s proposed including third-party beneficiaries is not was not signed, including in court. approach. The commenter asked that necessary. The main impetus for the expansion was to cover the types of 22 Id. at 5. 26 See 82 FR at 22774. scenarios noted by the Brauneis 23 See 17 U.S.C. 204, 205. 27 While the proposed rule did not specifically 33 24 Report, which would be covered by See Report of the Register of Copyrights on the include a certification concerning the signature, the 34 General Revision of the U.S. Copyright Law 95–96 Office believes that having one will aid the Office’s successors-in-interest. As was (Comm. Print. 1961) (in recommending that what examination just as much as the other proposed originally proposed,35 the Office is would become the current Copyright Act ‘‘require certifications, especially in light of the adopted requiring that any authorized explicitly that any instrument filed for recordation definition of ‘‘actual signature.’’ representative specify who they bear the actual signature of the person executing it 28 The interim rule does not substantively alter or a sworn or official certification that it is a true the definition of ‘‘official certification,’’ but clarifies represent and that successors-in-interest copy of the original signed instrument’’—which that it can be signed electronically. The interim rule closely resembles the current text of section does, however, simplify the definition of ‘‘sworn 31 Id. 205(a)—the report makes clear that the original certification,’’ as was proposed, 82 FR at 22774, 32 Id. intent was that ‘‘the recordation system should while also making the same clarification regarding 33 See 82 FR at 22774. embrace all instruments by which the ownership of electronic signatures. 34 See Brauneis Report at 67 (providing examples a copyright is transferred in whole or in part’’). 29 Commenters affirmatively supported having of wills where the testator is deceased and 25 See 82 FR at 22773–74; see also Report of the pre-printed certifications. See Authors Alliance documents in the current owner’s chain of title but Register of Copyrights on the General Revision of Comments at 5; Sergey Vernyuk Comments. They which were executed by predecessors-in-interest). the U.S. Copyright Law 96 (Comm. Print. 1961) also supported allowing a sworn certification to be While one commenter voiced support for the (explaining that the reason for requiring an ‘‘actual made to the best of the certifier’s knowledge. See proposed rule, third-party beneficiaries were not signature’’ is because ‘‘[t]here should be practical Authors Alliance Comments at 5; Sergey Vernyuk specifically discussed. See Authors Alliance assurance that the instrument recorded is precisely Comments; see also 82 FR at 22774. Comments at 5. the same as the one executed’’). 30 Music Parties Comments at 4. 35 82 FR at 22774–75.
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briefly describe the nature of their about the redactions. Most commenters it is regularly receiving written requests relationship to the document or the discussing redactions took issue with to redact additional categories of original parties to the document.36 this last requirement to provide the information as part of the interim rule, Completeness and Legibility. In Office with an unredacted copy of the and take that into account when response to the NPRM’s proposal on document or additional information formulating the final rule. completeness and legibility, the Office about the redactions, voicing serious English Language Requirement. In the received a technical suggestion on the security, privacy, and confidentiality NPRM, the Office proposed to continue provision’s wording that the Office concerns with the Office receiving, accepting and recording non-English agrees with.37 Thus, as under current having access to, and storing such language documents only if regulations, the Office will continue to sensitive materials.40 While one accompanied by an English translation require documents submitted for commenter did support the proposal,41 signed by the individual making the recordation to be complete and legible. the Office has decided to not include translation.46 The Office further But as the NPRM proposed, the this part of the provision in the interim proposed to extend the translation completeness requirement is being rule, especially given that the Office was requirement to any indexing simplified to mandate that, while the unlikely to require such information in information provided by the remitter. document must be complete by its the majority of cases. The Office Because the Office did not receive any terms, it need only include referenced cautions, however, that, as commenters objections to this aspect of the proposed schedules, appendices, exhibits, pointed out, over-redacting a document rule, and one commenter affirmatively addenda, or other material essential to may affect constructive notice under supported it,47 it is being adopted as understanding the copyright-related section 205(c).42 part of the interim rule. One commenter aspects of the document.38 This is a Additionally, one commenter also did, however, ask the Office to also change from current practice, where the asked that if an unredacted document is permit translations made by software or Office requires documents to include all submitted accidentally that there be a automated translation services.48 The schedules, or provide an explanation for simple process to replace it with a Office agrees, and has included such a why such material cannot be provided. properly redacted one.43 This would provision in the interim rule. This Thus, under the interim rule, if, for essentially be a type of correction. As adjustment should make it easier and example, a document has several such, the Office will more fully consider less costly to provide a translation. As schedules, but only one has any it in connection with its evaluation of to any concerns about accuracy, the relevance to the copyright-related terms the final rule on treatment of corrections Office notes that it may reject a of the agreement, the document would going forward (see Correcting Errors translation if it is unintelligible, be deemed complete so long as that below). The same commenter also whether made by a person or through schedule is included; the other suggested that the Office add more the use of software or automated schedules can be omitted. The Office flexibility to the proposed rule by service. sees no reason to burden remitters with adding the phrase ‘‘other similarly The Office would also like to clarify having to submit, and Office staff with sensitive information’’ to the acceptable that even though the translation reviewing, what can often be a categories of redactable information.44 requirement is being expanded to significant volume of material The Office declines to adopt this indexing information, the Office does completely unrelated to the copyright suggestion at this time. Other not intend to change its current terms of the document. commenters agreed with the proposed practices concerning non-English titles Redactions. The NPRM proposed categories, and the ability to make a of works at this time. If a non-English adopting rules governing redactions of written request to redact other title of a work is natively spelled using documents, generally limiting information should provide an adequate only the letters, numbers, and printable redactions to certain enumerated mechanism through which remitters can characters that appear in the ASCII 128- categories of sensitive information, seek additional redactions without character set (the character set the including financial, trade secret, and having a catch-all provision.45 The Office’s current systems are limited to), 39 personally identifiable information. Office, however, will evaluate whether a translation need not be provided, and The NPRM further proposed allowing if one is, the Office will index both the remitters to request in writing the ability 40 See Copyright Alliance Comments at 3; ESA English and non-English titles of the to redact other information from a Comments at 4; MPAA Comments at 4; Music work. If a non-English title is spelled document, which the Office may permit Parties Comments at 4–5. using characters outside that character at its discretion. The proposal also 41 See Kernochan Comments at 2 (‘‘[A]ll material set (for example, it is in French but has required that blank or blocked-out should be made available to the USCO if the USCO so requests.’’). accented letters, or is in Japanese), a portions of the document be labeled 42 See ESA Comments at 4 (noting that ‘‘remitters transliteration using the ASCII 128- ‘‘redacted’’ or an equivalent; that all are motivated by Section 205(c) not to redact character set may be provided instead of portions of the document required by information relevant to the purposes of or in addition to a literal translation. the simplified completeness recordation’’); Music Parties Comments at 4–5 (‘‘Section 205(c) . . . provides a strong incentive for Where both a translation and requirement be included (even if an remitters to redact only material that is irrelevant transliteration are provided, both will be entire page is redacted); and that upon to the purposes of recordation.’’). indexed as related titles. request, for review purposes, the 43 MPAA Comments at 4. Constructive Notice. The proposed remitter may be required to supply the 44 Id. rule sought to make clear that for Office with an unredacted copy of the 45 See ESA Comments at 4 (‘‘[T]his rule generally constructive notice under 17 U.S.C. document or additional information provides an appropriate framework for addressing cases where a document contains sensitive 205(c) to attach with regard to works to information.’’); MRI Comments at 5 (‘‘These data which a recorded document pertains, 36 See Music Parties Comments at 4 categories are appropriate for redaction.’’); Music the document must include or be (recommending that successors-in-interest Parties Comments at 4 (‘‘We generally agree with accompanied by the title and copyright ‘‘describe their relationship to the document or to the proposed approach to redactions. Allowing the signatories to the document’’). financial, trade secret and personally identifiable 37 See MPAA Comments at 6. information to be redacted as of right and other 46 82 FR at 22775. 38 82 FR at 22775. information to be redacted at the discretion of the 47 See Sergey Vernyuk Comments. 39 Id. Office should meet the needs of remitters.’’). 48 See Copyright Alliance Comments at 3.
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registration number of each such termination, and the date of recordation still evaluating these comments and has work.49 The Office received several is after the effective date of termination. not yet made a decision on this issue. comments objecting to the proposed As proposed,52 the interim rule For purposes of the interim rule, the rule on the ground that it is inconsistent clarifies that however the notice is Office is not changing the status quo for with the statute, which they contended signed, what must be submitted to the correcting information after a only requires that a title or registration Office for recordation is a copy of the as- recordation has been completed. As a number be provided for constructive served notice, including the reproduced result, a slightly modified version of the notice to attach.50 The Office is image of the signature as it appeared on current provision permitting corrections continuing to evaluate its proposal and that served notice. The interim rule also for electronic title lists has been these comments, including by closely adds new certification requirements, as retained. Mirroring the interim rule’s 53 examining the relevant legislative had also been proposed. Lastly, as the approach to preparing and submitting 54 history to better discern the intent NPRM discussed, remitters are now electronic title lists, the interim rule behind the statutory provision. For now, required to include a cover sheet with also omits the current instructions that the Office declines to adopt a rule any notice of termination submitted for detail how to submit a corrective filing interpreting section 205(c). Nothing recordation. This Recordation Notice of and instead states that a correction should be inferred from the Office’s Termination Cover Sheet (‘‘Form TCS’’) concerning an electronic title list may proposed provision or the Office’s is similar to and serves the same be requested by following the decision not to adopt a rule at this time. function as Form DCS does for section instructions provided by the Office on 205 document submissions. Form TCS its Web site. B. Notices of Termination asks for information about the remitter and for certain indexing information. It D. Consequences of Inaccuracies Commenters did not object to any of also includes a space for the remitter to In the NPRM, the Office said that it the proposed submission requirements provide a statement of service and make intended to continue its current practice or procedures for recording notices of the required certifications. of relying on the information provided termination, and the proposals have C. Correcting Errors by remitters for indexing purposes and largely been adopted. As the NPRM requiring parties-in-interest to bear the discussed, the requirements governing In the NPRM, the Office indicated that consequences of any inaccuracies in what must be submitted to the Office to it was inclined to continue its current such remitter-provided information.59 record a notice of termination are general practice of not permitting The NPRM also clarified that it is not remaining essentially unchanged.51 corrections to be made for any remitter- necessarily always the remitter who Thus, under the interim rule, as under caused inaccuracies after the document bears the consequences of inaccuracies, 55 the pre-existing rule, remitters are or notice is recorded. Instead, the but rather, more accurately, it is the required to provide a complete and Office proposed that, as is the current parties in interest to the remitted legible copy of the signed notice of practice, the remitter would need to document or notice of termination who termination as served on the grantee or resubmit the document or notice for bear the consequences, if any, of any successor-in-title. If separate copies of recordation with corrected information inaccuracies in the information the same notice were served on more and it would be treated as any other provided to the Office by the remitter. than one grantee or successor, only one first-time-submission. For purposes of Based on the comments received, the copy needs to be submitted to the Office uniformity and efficiency, the NPRM Office has decided to eliminate the part for recordation. The interim rule also proposed discontinuing permitting of the proposed rule stating that parties- maintains the requirement that remitters corrections for inaccurate electronic title 56 in-interest to a document or notice bear submit a statement setting forth the date lists that accompany paper filings. The the consequences, if any, of any on which the notice was served and the Office explained that such errors should inaccuracies in the information the manner of service, unless that be treated the same as those made on remitter provides to the Office. In information is already contained within the cover sheet or through the new response to the NPRM, some the notice itself. The interim rule also electronic system. Lastly, the NPRM commenters expressed confusion over makes clear that, as previously, where concluded that to have an efficient who really bears the consequences in service was made by first class mail, the recordation system with an affordable the notice of termination context, while date of service is the day the notice was fee, it would simply be impractical for another commenter pointed out that deposited with the post office. The Office staff to review all remitter- non-parties may also bear the provided indexing information, which Office’s timeliness rule also remains consequences if they rely to their also means that it would be very unchanged, and the Office will continue detriment on incomplete or inaccurate difficult to review ‘‘corrected’’ to refuse notices if they are untimely. recordation information.60 The Office submissions against the original to Such scenarios where a notice would be did not intend for the proposed rule to confirm that the remitter is not deemed untimely include when the be an assignment of risk or attempting to do something improper effective date of termination does not 57 responsibility to a particular party to a under the guise of a correction. transaction, but merely meant to make fall within the five-year period The Office received comments asking clear that the Copyright Office bears no described in section 203(a)(3) or section that corrections be permitted under responsibility for errors caused by a 304(c)(3), as applicable, the documents various circumstances.58 The Office is submitted indicate that the notice was remitter. To avoid any confusion, the served less than two or more than ten 52 Id. 59 82 FR at 22775–76. years before the effective date of 53 Id. at 22777. 60 See ESA Comments at 6; MRI Comments at 4– 54 Id. 5; Music Parties Comments at 7. Another 55 49 82 FR at 22776. Id. at 22776, 22777. commenter added that the proposed modification 50 See Author Services Comments at 1; Copyright 56 Id. at 22776. would seem to place the burden on any and every Alliance Comments at 4–5; ESA Comments at 4–5; 57 Id. party to a document to regularly and continually MPAA Comments at 4–6; Music Parties Comments 58 See Copyright Alliance Comments at 3; ESA check the Office’s records to ensure no one has at 7; SIIA Comments at 5–6. Comments at 5–6; MPAA Comments at 4; Music submitted inaccurate information. Sergey Vernyuk 51 82 FR at 22776–77. Parties Comments at 3, 5–6. Comments.
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Office has removed the provision. But, or completeness.62 The commenter discussed above, and in line with the to be clear, the Office bears no recommended that if that is not the Brauneis Report’s recommendation, the responsibility or liability if a remitter Office’s intent, that the Office follow the Office is requiring various certifications provides inaccurate indexing recommendation from the Brauneis and certain indexing information to be information that is then relied upon by Report,63 which suggested that the provided to the Office that, as the the Office in indexing the document. Office cease screening each individual interim rule makes clear, the Office will One commenter also asked that the remitted document for compliance with not necessarily check against the Office adopt a rule stating that when a the various recordation requirements.64 remitted document or notice itself. non-party relies to its detriment on The report recommended that remitters While the Office intends to only incomplete or inaccurate recordation instead should certify that a document examine submissions for facially records, it should constitute evidence satisfies all of the requirements for obvious deficiencies, it may continue to that any resulting infringement was not recordation, and that the Office only perform a more comprehensive review, willful.61 The Office declines to adopt ‘‘spot-screen’’ a sample of submissions such as for notices of termination, at its to identify systematic problems, with such a rule. It is for a court to determine discretion. Likewise, the Office also the goal of trying to reduce them willfulness in an infringement action reserves the right to engage in a less through corrective measures like better based on all of the particular facts at comprehensive review, closer to what education.65 The report did note, issue in a given case. the Brauneis Report recommended, as a however, that some particular types of Concerning the Office’s reliance on matter of administrative convenience. remitter-provided material, the Office submissions, such as notices of did not receive any comments critical of termination, might still warrant Even with a more comprehensive the proposed rule. Consequently, that document-by-document examination.66 level of review there is always the portion of the provision is being While the Office declines to adopt potential that some documents and retained. The interim rule makes slight this exact approach at this time, the notices that fail to comply with the changes to the proposed version of the Office has decided to implement requirements for recordation might still provision to clarify that the Office will something similar. The Office agrees get recorded by the Office because the not only rely on remitter-provided that it need not exhaustively review deficiency is simply not caught during indexing information, but also on the every recordation submission for the examination process. Consequently, certifications that accompany a compliance with all applicable laws, for clarity and avoidance of doubt, the document or notice and any other rules, and instructions, but there is a interim rule makes some adjustments to remitter-provided information. The benefit to both remitters and the public the existing notice of termination interim rule also makes plain that what at large in the Office at least examining provision concerning the legal effect of the Office means by reliance is that it submissions individually for facially recordation and adds a similar provision 67 may not necessarily confirm the obvious deficiencies so as to ensure for section 205 documents.69 The accuracy of any such certifications or that the majority of recorded documents interim rule makes even clearer that the information against the actual document and notices of termination are in act of recordation should in no way be itself. compliance with the legal and formal construed as a determination by the requirements for recordation.68 As E. Recordation Certificate and Returning Office that a document or notice is valid or legally effective. The interim rule also of Document 62 Kernochan Comments at 2. 63 makes plain that recordation is without As before, once recorded, the Id. 64 Brauneis Report at 58, 84. prejudice to any party claiming, document or notice of termination will 65 Id. including in court, that the be returned to the remitter with a 66 Id. requirements for recordation or certificate of recordation. Currently, all 67 To be clear, the Office means only those effectuating termination have not been recorded documents and notices are deficiencies pertaining to the requirements for met. digitally imaged and electronically recordation; not other types of deficiencies that could affect the underlying validity or legal List of Subjects in 37 CFR Part 201 stamped with an official recordation effectiveness of the document or notice. See U.S. number and page numbers. This Copyright Office, Compendium of U.S. Copyright Copyright, General provisions. stamped copy is then printed and sent Office Practices, sec. 2305 (3d ed. 2017) (‘‘Members to the remitter with a paper recordation of the general public who submit documents for certificate. Where an original document recordation cannot expect the Office to screen a 69 While the provision for section 205 documents document for even obvious errors or discrepancies. is technically new, the Office currently already is submitted, it is also returned. The Therefore, parties are strongly advised to review provides similar guidance. See U.S. Copyright Office plans to continue under this and scrutinize any document to ensure that the Office, Compendium of U.S. Copyright Office paper-based process while the new document is legally sufficient to accomplish the Practices, sec. 2305 (3d ed. 2017) (‘‘Although the electronic recordation system is being purpose for which it is intended before it is Office will record a document after it has been submitted for recordation.’’). executed, it does not issue or enforce notices of developed. 68 This is in contrast to, for example, examining termination, transfers of ownership, or other applications for copyright registration. Registering a documents pertaining to copyright. The Office only F. Scope of Office’s Examination and work involves a substantive determination by the serves as an office of public record for such Effect of Recordation Office as to a work’s copyrightability and can documents.... The fact that a document has been constitute prima facie evidence of a valid copyright. recorded is not a determination by the U.S. One commenter inquired into the See 17 U.S.C. 410(a)–(c). Recordation is a more Copyright Office concerning the validity or the level of review the Office performs in ministerial act, akin to the Office’s acceptance of effect of that document. That determination can examining recordation submissions, other types of filings for inclusion in the public only be made by a court of law. . . [T]he Office noting that it interpreted the NPRM’s record. For example, the Office accepts statements only examines documents to determine if they of account under the section 111 cable license after comply with the requirements of the Copyright Act proposed language about parties bearing a review for ‘‘obvious errors or omissions appearing and the Office’s regulations. The Office will not the consequences of their inaccuracies on the face of the documents’’ (see 37 CFR attempt to interpret the substantive content of any to indicate that the Office will not 201.17(c)(2)), notices of intention under the section document that has been submitted for recordation. review submitted materials for accuracy 115 compulsory license without review for ‘‘legal Likewise, the Office will not attempt to determine sufficiency,’’ ‘‘errors or discrepancies’’ (see 37 CFR whether a document satisfies the legal requirements 201.18(g)), and agent designations made pursuant to that may be necessary for it to be effective or 61 MRI Comments at 4–5. section 512(c)(2) without any examination. enforced.’’).
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Interim Regulations domain software (Pub. L. 101–650, sec. (d) Document requirements—(1) For the reasons set forth in the 805; see § 201.26); Original or certified copy. The remitter preamble, the Copyright Office amends (7) Notifications from the clerks of the must submit either the original 37 CFR part 201 as follows: courts of the United States concerning document that bears the actual actions brought under title 17, United signature(s) of the person(s) who PART 201—GENERAL PROVISIONS States Code (17 U.S.C. 508); executed it, or a copy of the original, (8) Notices to libraries and archives of signed document accompanied by a ■ 1. The authority citation for part 201 normal commercial exploitation or sworn certification or an official continues to read as follows: availability at reasonable prices (17 certification. Each document submitted Authority: 17 U.S.C. 702. U.S.C. 108(h)(2)(C); see § 201.39); for recordation must be certified to ■ 2. Revise § 201.4 to read as follows: (9) Submission of Visual Arts Registry either have the actual signature(s) (if it Statements (17 U.S.C. 113; see § 201.25); is an original document) or reproduce § 201.4 Recordation of transfers and other (10) Notices and correction notices of the actual signature(s) (in the case of a documents pertaining to copyright. intent to enforce restored copyrights (17 copy of the original document). All (a) General. This section prescribes U.S.C. 104A(e); see §§ 201.33, 201.34); documents lacking a handwritten, wet conditions for the recordation of and signature (including all documents transfers of copyright ownership and (11) Designations of agents to receive bearing an electronic signature) are other documents pertaining to a notifications of claimed infringement considered to be copies of the original, copyright under 17 U.S.C. 205. A (17 U.S.C. 512(c)(2); see § 201.38). signed document, and must be document is eligible for recordation (c) Definitions. For purposes of this accompanied by a sworn certification or under this section if it meets the section: an official certification. Where an actual requirements of paragraph (d) of this (1) A transfer of copyright ownership signature on the relevant document is section, if it is submitted in accordance has the meaning set forth in 17 U.S.C. not a handwritten or typewritten name, with the submission procedure 101. such as when an individual clicks a described in paragraph (e) of this (2) A document pertaining to a button on a Web site or application to section, and if it is accompanied by the copyright is any document that has a indicate agreement to contractual terms, fee specified in § 201.3(c). The date of direct or indirect relationship to the the remitter must submit a description recordation is the date when all of the existence, scope, duration, or of the nature of the signature and elements required for recordation, identification of a copyright, or to the documentation evidencing the existence including a proper document, fee, and ownership, division, allocation, of the signature (e.g., a database entry or any additional required information, are licensing, or exercise of rights under a confirmation email showing that a received in the Copyright Office. After copyright. That relationship may be particular user agreed to the terms by recordation the document is returned to past, present, future, or potential. clicking ‘‘yes’’ on a particular date). the sender with a certificate of (3) An actual signature is any legally Where such description and evidence recordation. The Office may reject any binding signature, including an are provided, the Office will make them document submitted for recordation that electronic signature as defined in 15 available for public inspection and may fails to comply with 17 U.S.C. 205, the U.S.C. 7006. presume that the signature requirement requirements of this section, or any (4) A sworn certification is a for recordation has been satisfied, relevant instructions or guidance statement made in accordance with 28 without prejudice to any party claiming provided by the Office. U.S.C. 1746 that the copy of the otherwise, including before a court of (b) Documents not recordable under document submitted for recordation is, competent jurisdiction. this section. This section does not to the best of the certifier’s knowledge, (2) Completeness. Each document govern the filing or recordation of the a true copy of the original, signed submitted for recordation must be, and following documents: be certified to be, complete by its terms, (1) Certain contracts entered into by document. A sworn certification must be signed by one of the parties to the but need only include referenced cable systems located outside of the 48 schedules, appendices, exhibits, contiguous States (17 U.S.C. 111(e); see signed document, a successor-in-interest to one of the parties to the signed addenda, or other material essential to § 201.12); understanding the copyright-related (2) Notices of identity and signal document, or the authorized aspects of the document. carriage complement, and statements of representative of such a party or account of cable systems and satellite successor. Authorized representatives (3) Legibility. Each document carriers and for digital audio recording must state who they represent and submitted for recordation must be, and devices and media (17 U.S.C. 111(d), successors-in-interest must describe be certified to be, legible. 119(b), and 1003(c); see §§ 201.11, their relationship to the document or (4) Redactions. The Office will accept 201.17, 201.28); the original parties to the document. An and make available for public (3) Notices of intention to obtain a authorized representative of a successor- inspection redacted documents certified compulsory license to make and in-interest must describe the successor’s to be redacted in accordance with this distribute phonorecords of nondramatic relationship to the document or the paragraph (d)(4), provided that all of the musical works (17 U.S.C. 115(b); see original parties to the document. A following conditions are satisfied: § 201.18); sworn certification may be signed (i) The redactions must be limited to (4) Notices of termination (17 U.S.C. electronically. financial terms, trade secret 203, 304(c) and (d); see § 201.10); (5) An official certification is a information, Social Security or (5) Statements regarding the identity certification, by the appropriate taxpayer-identification numbers, and of authors of anonymous and governmental official, that the original financial account numbers. Additional pseudonymous works, and statements of the document is on file in a public types of information may be redacted on relating to the death of authors (17 office and that the copy of the document a case-by-case basis if the need for any U.S.C. 302); submitted for recordation is a true copy such redactions is justified to the Office (6) Documents pertaining to computer of the original. An official certification in writing and approved by the Office; shareware and donation of public may be signed electronically. such written requests should be
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included in the remitter’s recordation be recorded. The electronic list must be ■ 3. Revise § 201.10(f) to read as submission to the Office. prepared and submitted to the Office in follows: (ii) The blank or blocked-out portions the manner specified by the Copyright of the document must be labeled Office in instructions made available on § 201.10 Notices of termination of transfers and licenses. ‘‘redacted’’ or the equivalent. its Web site. The Office may reject any (iii) Each portion of the document document submitted for recordation that * * * * * required by paragraph (d)(2) of this includes an improperly prepared (f) Recordation. A copy of a notice of section must be included. electronic title list. termination shall be recorded in the (5) English language requirement. The (ii) If a remitter of a recorded Copyright Office as required by 17 Office will accept and record non- document finds that an error or U.S.C. 203(a)(4)(A), 17 U.S.C. English language documents and omission in an electronic title list has 304(c)(4)(A), or 17 U.S.C. 304(d)(1) if it indexing information only if led to the inaccurate indexing of the meets the requirements of paragraph accompanied by an English translation document in the public catalog, the (f)(1) of this section, is submitted in that is either signed by the individual remitter may request that the record be compliance with paragraph (f)(2) of this making the translation or, if a publicly corrected by following the instructions section, and is accompanied by the fee available commercial or consumer provided by the Office on its Web site. specified in § 201.3(c). The Office may translation software product or Upon receipt of a properly prepared reject any notice submitted for automated service is used, by the corrective filing and the appropriate fee, recordation that fails to comply with 17 individual using such product or service the Office will proceed to correct the U.S.C. 203(a), 17 U.S.C. 304(c), 17 and accompanied by the name of the information in the public catalog, and U.S.C. 304(d), the requirements of this product or service. All translations will will make a note in the record section, or any relevant instructions or be made available for public inspection indicating that the corrections were guidance provided by the Office. and may be redacted in accordance with (1) Requirements. The following made and the date they were made. paragraph (d)(4) of this section. requirements must be met before a copy (e) Paper submission procedure—(1) (4) Return receipt. If a remitter of a notice of termination may be Process. A document may be submitted includes two copies of a properly recorded in the Copyright Office. for recordation by sending it to the completed Form DCS indicating that a (i) What must be submitted—(A) Copy appropriate address in § 201.1(b) or to return receipt is requested, as well as a of notice of termination. A copy of a such other address as the Office may self-addressed, postage-paid envelope, notice of termination submitted for specify, accompanied by a cover sheet, the remitter will receive a date-stamped recordation must be, and be certified to the proper fee, and, if applicable, any return receipt attached to the extra copy be, a true, correct, complete, and legible electronic title list. Absent special acknowledging the Copyright Office’s copy of the signed notice of termination arrangement with the Office, the Office receipt of the enclosed submission. The as served. Where separate copies of the reserves the right to not process the completed copies of Form DCS and the same notice were served on more than submission unless all of the items self-addressed, postage-paid envelope one grantee or successor-in-title, only necessary for processing are received must be included in the same package one copy need be submitted for together. as the submitted document. A return recordation. (2) Cover sheet required. Submission receipt confirms the Office’s receipt of (B) Statement of service. The copy of a document must include a the submission as of the date indicated, submitted for recordation must be completed Recordation Document Cover but does not establish eligibility for, or accompanied by a statement setting Sheet (Form DCS), available on the the date of, recordation. forth the date on which the notice was Copyright Office Web site. Remitters (5) Remitter certification. The remitter served and the manner of service, unless must follow all instructions provided by must certify that he or she has such information is contained in the the Office in completing Form DCS, appropriate authority to submit the notice. In instances where service is including by providing all requested document for recordation and that all made by first class mail, the date of indexing information. Form DCS may be information submitted to the Office by service shall be the day the notice of used to provide a sworn certification, if the remitter is true, accurate, and termination was deposited with the appropriate, and to make any of the complete to the best of the remitter’s United States Postal Service. other certifications required by this knowledge. (ii) Timeliness. (A) The Copyright section. Form DCS will not be (f) Reliance on remitter-provided Office will refuse recordation of a notice considered part of the recorded information. The Copyright Office will of termination as such if, in the document, but will be used by the rely on the certifications submitted with judgment of the Copyright Office, such Office for examination, indexing, and a document and the information notice of termination is untimely. other administrative purposes. The provided by the remitter on Form DCS Conditions under which a notice of Office may reject any document and, if provided, in an accompanying termination will be considered untimely submitted for recordation that includes electronic title list. The Office will not include: the effective date of an improperly prepared cover sheet. necessarily confirm the accuracy of such termination does not fall within the (3) Electronic title list. (i) In addition certifications or information against the five-year period described in section to identifying the works to which a submitted document. 203(a)(3) or section 304(c)(3), as document pertains in the paper (g) Effect of recordation. The fact that applicable, of title 17, United States submission, the remitter may also the Office has recorded a document is Code; the documents submitted indicate submit an electronic list setting forth not a determination by the Office of the that the notice of termination was each such work. The electronic list will document’s validity or legal effect. served less than two or more than ten not be considered part of the recorded Recordation of a document by the years before the effective date of document, but will be used by the Copyright Office is without prejudice to termination; or the date of recordation is Office for indexing purposes. Absent any party claiming that the legal or after the effective date of termination. special arrangement with the Office, the formal requirements for recordation (B) If a notice of termination is electronic list must be included in the have not been met, including before a untimely, the Office will offer to record same package as the paper document to court of competent jurisdiction. the document as a ‘‘document
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pertaining to a copyright’’ pursuant to including the prescribed fee and, if those that are filed in the Office after § 201.4, but the Office will not index the required, the statement of service, have failed delivery to the copyright owner. document as a notice of termination. been received in the Copyright Office. DATES: Effective December 18, 2017. (C) In any case where an author After recordation, the notice, including FOR FURTHER INFORMATION CONTACT: agreed, prior to January 1, 1978, to a any accompanying statement, is Sarang V. Damle, General Counsel and grant of a transfer or license of rights in returned to the sender with a certificate Associate Register of Copyrights, by a work that was not created until on or of recordation. email at [email protected], or Jason E. after January 1, 1978, a notice of (4) Effect of recordation. The fact that Sloan, Attorney-Advisor, by email at termination of a grant under section 203 the Office has recorded a notice is not [email protected]. Each can be contacted by of title 17 may be recorded if it recites, a determination by the Office of the telephone by calling (202) 707–8350. as the date of execution, the date on notice’s validity or legal effect. SUPPLEMENTARY INFORMATION: which the work was created. Recordation of a notice of termination (2) Paper submission procedure—(i) by the Copyright Office is without I. New Recordation Fee for Electronic Process. A copy of a notice of prejudice to any party claiming that the Title Lists termination may be submitted for legal or formal requirements for A. Background recordation by sending it to the effectuating termination (including the appropriate address in § 201.1(c) or to requirements pertaining to service and This final rule adjusts U.S. Copyright such other address as the Office may recordation of the notice of termination) Office fees in accordance with 17 U.S.C. specify, accompanied by a cover sheet, have not been met, including before a 708. Section 708(a) specifies that ‘‘[f]ees the statement of service, and the proper court of competent jurisdiction. shall be paid to the Register of fee. (5) Reliance on remitter-provided Copyrights’’ for services, including a set (ii) Cover sheet required. Submission information. The Copyright Office will of specified services enumerated in of a copy of a notice of termination must rely on the certifications submitted with paragraphs (1) through (11) of that 1 be accompanied by a completed a notice and the information provided subsection. This includes, as relevant Recordation Notice of Termination by the remitter on Form TCS and, if here, fees for ‘‘the recordation, as Cover Sheet (Form TCS), available on provided, in an accompanying provided by section 205, of a transfer of the Copyright Office Web site. Remitters statement of service. The Office will not copyright ownership or other must follow all instructions provided by 2 necessarily confirm the accuracy of such document.’’ Fees for this service and the Office in completing Form TCS, certifications or information against the the other services specifically including by providing all requested submitted notice. enumerated in section 708(a)(1)–(9) are indexing information. Form TCS may be to be set forth in a proposed schedule used to provide the statement of service * * * * * that is sent to Congress 120 days before and to make any of the certifications Dated: October 25, 2017. the adjusted fees can take effect.3 The required by this paragraph (f). Form TCS Karyn Temple Claggett, fee may go into effect after the end of will not be considered part of the Acting Register of Copyrights and Director that period unless ‘‘a law is enacted recorded notice, but will be used by the of the U.S. Copyright Office. stating in substance that the Congress Office for examination, indexing, and Carla D. Hayden, does not approve the schedule.’’ 4 other administrative purposes. The Librarian of Congress. Before proposing new fees for the Office may reject any notice submitted [FR Doc. 2017–24527 Filed 11–9–17; 8:45 am] services enumerated in (1) through (9), for recordation that includes an the Register must conduct a study of the BILLING CODE 1410–30–P improperly prepared cover sheet. Office’s costs and must consider the (iii) Return receipt. If a remitter timing of any fee adjustments and the includes two copies of a properly LIBRARY OF CONGRESS Office’s authority to use the fees completed Form TCS indicating that a consistent with the Office’s budget.5 return receipt is requested, as well as a Copyright Office Section 708(b) further provides that the self-addressed, postage-paid envelope, Register may adjust these fees to ‘‘not the remitter will receive a date-stamped 37 CFR Part 201 more than that necessary to cover the return receipt attached to the extra copy reasonable costs incurred by the acknowledging the Copyright Office’s [Docket No. 2017–17] Copyright Office for . . . [such receipt of the enclosed submission. The services], plus a reasonable inflation completed copies of Form TCS and the Fees for Electronic Recordation and adjustment to account for any estimated self-addressed, postage-paid envelope Notices of Intention To Obtain a increase in costs.’’ 6 Finally, section must be included in the same package Compulsory License 708(b) also mandates that the ‘‘[f]ees [so] as the submitted notice. A return receipt established . . . shall be fair and confirms the Office’s receipt of the AGENCY: U.S. Copyright Office, Library equitable and give due consideration to submission as of the date indicated, but of Congress. does not establish eligibility for, or the ACTION: Final rule. 1 17 U.S.C. 708(a). date of, recordation. 2 Id. at 708(a)(4). (iv) Remitter certification. The SUMMARY: The U.S. Copyright Office is 3 Id. at 708(b)(5). remitter must certify that he or she has publishing a final rule establishing a 4 Id. Section 708(a) also authorizes the Register to appropriate authority to submit the separate, lower filing fee for recording fix fees for other services not enumerated in section 708(a)(1)–(9), such as the cost of preparing copies notice for recordation and that all documents when they are submitted of Office records. Id. at 708(a). The fees for these information submitted to the Office by with an electronic title list. Separately, additional Office services, as well as fees for the the remitter is true, accurate, and the Office is noting a policy change, filing of cable and satellite statements of account complete to the best of the remitter’s effective on the same date as the final under paragraphs (10) and (11) of section 708(a), need not be submitted to Congress, but are instead knowledge. rule, to require the payment of fees for established by the Register of Copyrights by (3) Date of recordation. The date of the filing of all notices of intention to regulation based on the Office’s costs. Id. recordation is the date when all of the obtain a compulsory license to make 5 Id. at 708(b)(1). elements required for recordation, and distribute phonorecords, including 6 Id. at 708(b)(2).
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the objectives of the copyright spreadsheet.11 Document recordation service. This prospective approach was system.’’ 7 fees, however, were last adjusted before used because, concurrent with the the introduction of electronic title lists. effective date of this rule, the Office is B. Cost Study Thus, the Office has never set a separate implementing a new, more efficient Pursuant to section 708, the Office fee for recording documents with such process for providing this service than submitted a proposed fee schedule and lists, and currently charges the same the one currently employed. This analysis to Congress on August 18, recordation fee regardless of whether methodology was reviewed and 2017.8 That study and this final rule the document has an electronic title list. validated by an independent consulting implementing the fee it proposed As a result, the Office’s cost study firm. concern a single Copyright Office proposed implementing a separate, The new fee for documents submitted service: The recording of documents reduced filing fee for groups of with electronic title lists to be accompanied by electronic title lists, additional titles provided in an implemented by this final rule is as i.e., lists of certain indexing information electronic title list that accompanies a follows: about the works to which such document submitted for recordation. 9 1 to 50 additional titles: $60 documents pertain. The fee adjustment implemented by this 51 to 500 additional titles: $225 Since 1870, the Copyright Office has final rule only pertains to that fee. The 501 to 1,000 additional titles: $390 recorded documents pertaining to works Office is not adjusting the baseline 1,001 to 10,000 additional titles: $555 under copyright, such as assignments, document recordation fee of $105 at this 10,001 or more additional titles: $5,550 licenses, and grants of security interests. time; that fee will remain the same for In the analysis submitted to Congress, Under the Copyright Act, recordation of recordations made both with and such documents is voluntary, but the Office determined that while use of without electronic title lists. Nor is the electronic title lists can significantly provides certain legal entitlements, such Office adjusting the fee for groups of as constructive notice of the facts stated increase the Office’s processing additional titles when an electronic title efficiency, remitters had little incentive in the recorded document when certain list is not used. Proposals for those fees conditions are met.10 Thus, the Office to use them. Thus, the Office proposed, will be included in a comprehensive and is now instituting, a fee for using has an important interest in ensuring study of all Copyright Office costs and that the public record of copyright electronic title lists that is generally fees expected to be submitted to lower than the current fee for transactions is as timely, complete, and Congress next year. recordations made without them. The accurate as possible. The fee-setting methodology lower fee is being adopted primarily to In general, the recordation process is employed by the study used activity- still paper based, and Office staff based costing principles which comply incentivize use of electronic title lists manually transcribe information from for documents with more than ten with standards set for federal 15 documents into an electronic format to managerial accounting 12 and with additional titles in an effort to permit indexing in the Office’s public guidance for fee setting as published by increase administrative efficiency and to catalog. Among the information that the Office of Management and Budget offer a less expensive avenue to must be indexed are the titles of and Circular A–25 Revised: User Charges,13 obtaining the benefits of recording a related information for copyrighted and the Government Accountability document with the Copyright Office. works associated with the document Office.14 Under the approach, total costs In considering the fairness, equity, submitted for recordation, which are for the entire recordation function were and objectives of the copyright system, typically presented in a list appended to used to develop a time-based multiplier, the Office believes that offering the document, referred to informally as which was then used to calculate the recordation services for a lower fee, a ‘‘title appendix.’’ A title appendix cost of the individual activities for where remitters have done the work to associated with a document can include recording the information contained in create an electronic title list, should hundreds, or even thousands, of titles. electronic title lists. The total cost of result in a wider range of remitters The manual entry of information from completing an electronic title list submitting documents and may also title appendices is a significant transaction was determined by result in existing remitters submitting contributor to long processing times in aggregating the cost of each individual additional or updated documents with the Office’s Recordation Section. In activity. more frequency than they might 2014, to gain efficiencies, the Office Cost studies of this type are typically otherwise. Receipt of additional promulgated a new rule permitting retrospective, using actual data from a recorded documents should result in documents submitted for recordation to fiscal year that has concluded. This greater copyright ownership data being be accompanied by an electronic title study used actual data from fiscal year incorporated into the Office’s records, list in the form of an Excel 2016, but the methodology was applied which furthers the Office’s mission and prospectively against a planned new benefits the public at large. 7 Id. at 708(b)(4). In its analysis, the Office also 8 The study is available on the Office’s Web site 11 See 79 FR 55633 (Sept. 17, 2014) (codified at determined that as compared to at https://www.copyright.gov/policy/feestudy2017/ 37 CFR 201.4(c)(4)). manually indexing documents, where fee-study-2017.pdf. 12 This includes the Federal Accounting more titles generally means more 9 Examples of such indexing information can Standards Advisory Board’s Managerial Cost processing time and higher costs, when include the types of works, the titles of the works Accounting Concepts and Standards for the Federal (including alternate titles), their respective Government, which promotes activity-based costing an electronic title list is used, registration numbers, and authorship information. for calculating the cost of providing services. See processing time is typically more 10 17 U.S.C. 205(c) (‘‘Recordation of a document Fed. Accounting Standards Advisory Bd., Statement constant. However, in further evaluating in the Copyright Office gives all persons of Federal Financial Accounting Standards No. 4: the fairness, equity, and objectives of constructive notice of the facts stated in the Managerial Cost Accounting Concepts and recorded document, but only if—(1) the document, Standards for the Federal Government (1995). the copyright system, the Office has or material attached to it, specifically identifies the 13 See Office of Mgmt. and Budget, Circular No. work to which it pertains so that, after the A–25 Revised: User Charges, Whitehouse.gov, 15 Though documents with ten or fewer document is indexed by the Register of Copyrights, http://www.whitehouse.gov/omb/circulars_a025 additional titles may be submitted with an it would be revealed by a reasonable search under (last visited Aug. 13, 2017). electronic title list, the final rule will deliver fee the title or registration number of the work; and (2) 14 See U.S. Gov’t Accountability Office, Federal savings to remitters where documents have more registration has been made for the work.’’). User Fees: A Design Guide (GAO–08–386SP) (2008). than ten additional titles.
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decided to adopt a tiered pricing owner in the form and manner specified same filing fee ‘‘should be charged in structure based on the number of titles by Copyright Office regulations.16 both cases.’’23 The final rule, effective in to which the document pertains. Under In two circumstances, however, an 2004, adopted that proposal, repealing this scheme, larger filers submitting NOI can be filed with the Copyright the regulatory language that had documents with a larger number of titles Office rather than the copyright owner. expressly prohibited charging a fee.24 pay a higher fee for the added benefit First, if the public records of the Consistent with this rulemaking, the they receive (when the fee is viewed on Copyright Office do not identify the Copyright Office’s fee schedule does not a per-title basis) to offset the lower total copyright owner and include an address distinguish between different types of fee for smaller filers with fewer titles. at which notice can be served, the NOI NOIs.25 The first four tiers of the proposed can instead be filed with the Office.17 In practice, however, and in part due schedule increase incrementally based These ‘‘unidentified NOIs’’ can be filed to the extremely low volume of on the total number of additional titles electronically or in paper hard copy, returned-to-sender NOIs the Office submitted. The reason for the larger though a discounted fee is offered for received in the years following adoption jump between the fourth and fifth tiers electronic submissions.18 of the 2004 rule, the Office abstained is because of the significant added costs Second, if the NOI is sent to the last from imposing the established fee. In to the Office to process documents with address for the copyright owner shown recent years, however, the volume of 10,000 or more titles, caused by current by the Office’s records, but is returned returned-to-sender NOIs has increased system limitations. to the sender because the copyright sharply. Last year the Office received The Office notes that the proposed fee owner was no longer located at that over 800 such NOIs, and this year the schedule will be revisited as part of a address or refused to accept delivery, Office has received over 2,000 to date. comprehensive study of all Office costs the Office’s regulations permit the Each of these NOIs must be individually and fees to be completed next year. As ‘‘original Notice as sent’’ to be filed with and manually processed. Because of this discussed above, the goal of the the Office, along with a ‘‘brief statement increased burden, the Office can no proposed fee schedule is primarily to that the Notice was sent to the last longer afford to forbear from the incentivize use of electronic title lists. address for the copyright owner shown collection of fees. Accordingly, this To do that, the proposed fee offers a by the records of the Copyright Office document announces a policy change discount from the ordinary recordation but was returned,’’ and may also ‘‘be that will be implemented on December fee of $35 per group of ten additional accompanied by appropriate evidence 18, 2017: Any returned-to-sender NOIs titles. When the full fee study examines that it was mailed to, or that delivery by received in the Office on or after that all Office costs and evaluates an reputable courier service was attempted date must be accompanied by the same appropriate fee to record a document at, that address.’’ 19 Typically, for these filing fee applicable to other paper-filed without an electronic title list in light of ‘‘returned-to-sender NOIs,’’ the Office NOIs, which is currently $75 plus $20 current costs, it is possible that fee will receives the NOI in the original mailing per group of one to ten additional increase, in which case it is also envelope marked with a return to sender titles.26 The Office is publicly possible that the fee being adopted for label. The Office does not currently announcing this policy change in using an electronic title list may be have any mechanism for accepting these advance to give remitters of returned-to- adjusted upward as well to ensure NOIs electronically.20 sender NOIs time to adjust their adequate cost recovery. The Office’s regulations used to practices. C. Effective Date explicitly state that no filing fee would be charged for returned-to-sender NOIs, List of Subjects in 37 CFR Part 201 Congress’s 120-day review period while such a fee would be charged for Copyright, General provisions. under 17 U.S.C. 708(b)(5) began after the 21 the unidentified NOIs. But in 2001, Final Regulations Office submitted the proposed fee the Office issued a notice of proposed schedule and analysis on August 18, rulemaking seeking to remove this For the reasons set forth in the 2017. If no law is enacted stating in limitation, as ‘‘[t]he cost to the Office of preamble, the Copyright Office amends substance that Congress does not processing the filing of a Notice of 37 CFR part 201 as follows: approve of the proposed recordation fee Intention is the same whether the during such time, the fee will be copyright owner is not identified in the PART 201—GENERAL PROVISIONS instituted pursuant to this final rule, records of the Office or the copyright effective December 18, 2017. ■ 1. The authority citation for part 201 owner is no longer located at the continues to read as follows: II. Notices of Intention address shown in the records of the Authority: 17 U.S.C. 702. Though not related to the above- Office or has refused to accept 22 ■ 2. Amend § 201.3 by revising discussed cost study or final rule, the delivery.’’ The Office believed that the paragraph (c)(16) to read as follows: Office is taking this opportunity to 16 provide public notice that it will See generally 37 CFR 201.18. 17 17 U.S.C. 115(b)(1). § 201.3 Fees for registration, recordation, implement a policy change regarding 18 37 CFR 201.3(e)(1). and related services, special services, and fees for notices of intention to obtain a 19 Id. § 201.18(f)(2). services performed by the Licensing compulsory license to make and 20 See id. Division. distribute phonorecords (‘‘NOIs’’). 21 Compare 37 CFR 201.18(e)(1) (2003) (‘‘Notices * * * * * Under the Copyright Act, section 115 of Intention submitted for filing shall be (c) * * * establishes a compulsory license, accompanied by the fee specified in § 201.3(e).’’) with id. § 201.18(e)(3) (‘‘No filing fee will be whereby anyone may make and required in the case of Notices filed under this regard to the licensee’s reason for filing the Notice distribute phonorecords of nondramatic paragraph.’’). with the Office’’). 23 musical works, subject to certain terms 22 66 FR 45241, 45243 (Aug. 28, 2001); see also 66 FR at 45243; see also 69 FR at 11572. 24 and conditions, and upon paying 69 FR 11566, 11572 (Mar. 11, 2004) (additional, 69 FR 34578, 34583 (June 22, 2004). related notice of proposed rulemaking reiterating 25 See 37 CFR 201.3(e)(1) (establishing a fee for royalties when applicable. To obtain a that ‘‘the Office intends to amend its rules to ‘‘[r]ecordation of a notice of intention to make and compulsory license, a licensee must require a filing fee in each instance where the distribute phonorecords’’ without differentiation). serve an NOI on the relevant copyright Notice is filed with the Copyright Office without 26 See id.
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Fees Registration, recordation and related services ($)
******* (16) Recordation of a document, including a notice of intention to enforce ...... Single title ...... 105 Additional titles (per group of 1 to 10 titles) ...... 35 Additional titles provided in an electronic title list 1 to 50 additional titles ...... 60 51 to 500 additional titles ...... 225 501 to 1,000 additional titles ...... 390 1,001 to 10,000 additional titles ...... 555 10,001 or more additional titles ...... 5,550 Correction of online Public Catalog data due to erroneous electronic title submission (per title) ...... 7
*******
* * * * * questionnaire. If, based on the answers Office Web site at http://copyright.gov/ Dated: October 24, 2017. to the questionnaire, the test items rulemaking/securetests/. If electronic Karyn Temple Claggett, appear to be eligible for the group submission of comments is not feasible registration option, the Office will due to lack of access to a computer and/ Acting Register of Copyrights and Director of the U.S. Copyright Office. contact the applicant and schedule an or the internet, please contact the Office appointment to deliver these materials for special instructions using the contact Approved by: to the Office in person. On the information below. Carla D. Hayden, appointed date, the applicant must FOR FURTHER INFORMATION CONTACT: Librarian of Congress. bring a copy of the application and a Robert J. Kasunic, Associate Register of [FR Doc. 2017–24526 Filed 11–9–17; 8:45 am] complete unredacted copy of the actual Copyrights and Director of Registration BILLING CODE 1410–30–P test items. In addition, the applicant Policy and Practice; Sarang Vijay Damle, must bring a redacted copy of the test General Counsel and Associate Register items, and a signed declaration of Copyrights; Erik Bertin, Deputy LIBRARY OF CONGRESS confirming that this copy is identical to Director of Registration Policy and the redacted copy that was uploaded to Practice; or Abioye Ella Mosheim, Copyright Office the electronic registration system. The Attorney-Advisor, by telephone at 202– Office will examine each test item to 707–8040 or by email at [email protected], 37 CFR Part 202 determine if it contains sufficient [email protected], [email protected], and [Docket No. 2017–8] copyrightable authorship. If the Office [email protected]. registers the claim, the registration will SUPPLEMENTARY INFORMATION: Secure Tests cover each test item as a separate work of authorship, and the registration will I. Background AGENCY: U.S. Copyright Office, Library be effective as of the date the Office of Congress. A. General Provisions Regarding initially received the application, filing Copyright Registration ACTION: Interim rule with request for fee, and the redacted copy of the test comments. items in proper form through the Under the Copyright Act of 1976, the electronic registration system. To be U.S. Copyright Office (the ‘‘Copyright SUMMARY: The U.S. Copyright Office is clear, the previous interim rule Office’’ or ‘‘Office’’) is responsible for issuing an update to its interim rule, otherwise remains in effect, and registering copyright claims. See 17 issued June 12, 2017, governing applicants may continue to use that rule U.S.C. 408. In doing so, the Office has registration of secure tests. Based on the to register individual secure tests. The a statutory obligation to confirm that the initial comments received on that Office welcomes public comment on legal and formal requirements for interim rule, the Office has determined both this interim rule and the June 12, registration have been met, such as that there is an immediate need to 2017 interim rule. confirming fixation and examining the establish a new group registration work for copyrightable authorship. See option for secure test questions and DATES: Effective November 13, 2017. 17 U.S.C. 410(a) (obligating the Register answers and other related materials Comments on this interim rule and the of Copyrights (the ‘‘Register’’) ‘‘after (referred to as ‘‘test items’’) that are interim rule published on June 12, 2017 examination’’ to ‘‘determine[ ] that . . . stored in an electronic database, test (82 FR 26850), must be made in writing the material deposited constitutes bank, or other medium of expression. and must be received by the U.S. copyrightable subject matter and that This interim rule incorporates most of Copyright Office no later than December the other legal and formal requirements the same procedures that the Office 11, 2017. of this title have been met’’). adopted in its recent interim rule on ADDRESSES: For reasons of government The Office has the further obligation secure tests and adds additional efficiency, the U.S. Copyright Office is to obtain a registration deposit that is procedures for group registration. To using the regulations.gov system for the sufficient to verify the scope of the seek a group registration, applicants will submission and posting of public claim, and to provide an adequate be required to submit an online comments in this proceeding. All archival record of what was examined application, upload a redacted copy of comments are therefore to be submitted and registered. Id. 408(b) (generally the individual test items to the electronically through regulations.gov. requiring a ‘‘complete’’ copy of works electronic registration system, and Specific instructions for submitting deposited for registration); id. 705(a) complete and submit a brief comments are on the U.S. Copyright (requiring the Register to ‘‘ensure that
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records of deposits . . . are (1978). At the same time, the Office registration of secure tests came into maintained’’); id. 705(b) (requiring the recognized the need to retain some increasing tension with the general rules Register to make ‘‘the articles deposited evidence of the work that had been governing copyright registration. in connection with completed copyright examined and registered. Accordingly, As a result, on June 12, 2017, the registrations and retained under the the regulation required that ‘‘sufficient Office issued an interim rule that control of the Copyright Office . . . portions, description[s], or the like [be] memorialized certain aspects of its open to public inspection’’). In the case retained so as to constitute a sufficient secure test procedure, and adopted new of unpublished works, the Office is archival record of the deposit.’’ Id. In procedures to increase the efficiency of statutorily required to keep the deposit promulgating this regulation, the Office its examination of secure tests. See 82 for the full term of copyright protection. also offered that ‘‘[a]s a matter of FR 26850 (June 12, 2017). In addition, 17 U.S.C. 704(d). practice, special arrangements can be the interim rule brought secure test made for the examination of such registration procedures back into B. Secure Test Registration Procedures materials under strict conditions of alignment with the underlying statutory In 1978, as part of the regulations security and in the presence of a and regulatory framework for copyright implementing the 1976 Copyright Act, representative of a copyright owner.’’ 42 registration. In particular, the Office the Office issued a regulation that FR at 59304. made clear that only those works that established a special procedure to Initially, this procedure was used to satisfy the regulatory definition of a exempt ‘‘secure tests’’ from some of the register secure tests administered with ‘‘secure test’’ would be eligible for the otherwise applicable rules for physical booklets, as that was the type secure test procedure. Id. at 26851. In registration, deposit, and examination. of ‘‘work’’ the Office had in mind when addition, the Office noted that, under its The Office explained that this procedure the regulation was adopted. Beginning longstanding regulation, the redacted was specifically designed for tests ‘‘used in the 1990’s, the Office expanded its copy must contain a sufficient archival in connection with admission to procedures—without altering the record of what was submitted for educational institutions, high school underlying regulation—to permit secure registration, and that its prior practices equivalency, placement in or credit for registration of tests administered in a allowing for the registration of test item undergraduate and graduate course machine-readable format and secure banks were in considerable tension with work, awarding of scholarships, and tests administered with physical that requirement. Id. at 26851. The professional certification’’ and that it booklets containing questions taken Office therefore declined to permit was intended to protect the confidential from an automated database. This registration of test item banks under nature of these works. See 42 FR 59302, procedure mirrored the procedure those prior practices. 59304 & n.1 (Nov. 16, 1977) (noting described above, with the exception of The Office issued the June 12, 2017 correspondence from the Educational the deposit requirement. Specifically, rule on an interim basis and before Testing Service, American College applicants could bring an unredacted receiving public comments, in part, Testing Program, The College Entrance copy of the entire test to the in-person because it memorialized most of the Examination Board, The American appointment, or alternatively, they Office’s longstanding procedures for Council on Education, the Law School could bring 50 unredacted pages from examining secure tests, and because the Admission Council, the National Board the test or the database of test questions. improvements in that process were of Medical Examiners, the Federation of With respect to the redacted copy of the expected to provide immediate benefits State Medical Boards, and the National test, applicants could use the same for test publishers. See 82 FR 26853. Conference of Bar Examiners, among procedure used to examine physical test The Office invited comment on the others). In establishing this special booklets, or alternatively, they could interim rule and provided a generous procedure, the Office adopted a submit 50 redacted pages from the test amount of time for public input before definition of ‘‘secure tests’’ that it or the underlying database of test issuing a final rule to give applicants believed would best identify the kinds questions. Still later, the Office and the Office an opportunity to of tests that raised special modified this procedure—again without evaluate the new procedures based on confidentiality concerns.1 revisiting the regulation—stating that actual experience. Furthermore, the Office observed that applicants could submit the title page of II. Group Registration of Secure Test ‘‘although secure tests should be the test, a redacted copy of the last page Items deposited in the Copyright Office for of the test, and 50 pages from the test examination incident to registration or database of test questions (either in Although the deadline for submitting under section 408, their retention by the redacted or unredacted form). While the comments does not expire until Office and availability for public Office described these procedures in a December 11, 2017, many commenters inspection could severely prejudice the circular (Copyright Registration of have expressed significant concerns future utility, quality, and integrity of Secure Tests (Circular 64)), they were about the June 12, 2017 interim rule, the materials.’’ Id. Accordingly, the never incorporated into the Office’s contending that it restricts their ability Office adopted a regulation providing regulations and were never the subject to register, in a secure manner, test that ‘‘[i]n the case of any secure test the of a formal rulemaking. items (i.e., sets of questions and Copyright Office will return the deposit While these post-1978 changes to the answers) stored in or pulled from to the applicant promptly after secure test procedure were an attempt to electronic databases and test banks.2 examination.’’ 37 CFR 202.20(c)(2)(vi) be responsive to developments in the marketplace—as the testing industry 2 See e.g., PSI Comments at 7–8; Am. Board of 1 The regulation defined a ‘‘secure test’’ as ‘‘a moved from using static test booklets to Fam. Med., Inc., Comments at 2; NBCRNA nonmarketed test administered under supervision randomized or adaptive tests delivered Comments at 2. In addition, many comments called at specified centers on specific dates, all copies of for updates to the longstanding regulatory which are accounted for and either destroyed or by a computer—they did not ensure, definition of ‘‘secure test,’’ which is defined as ‘‘a returned to restricted locked storage following each among other things, an adequate deposit nonmarketed test administered under supervision administration. For these purposes a test is not that could serve as a long-term record of at specified centers on scheduled dates, all copies marketed if copies are not sold but it is distributed what material was examined and of which are accounted for and either destroyed or and used in such a manner that ownership and returned to restricted locked storage following each control of copies remain with the test sponsor or registered. As a result, over time the administration.’’ 37 CFR 202.13(b)(1). Although the publisher.’’ 37 CFR 202.20(b)(4) (1978). Office’s special procedures for Continued
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The Office appreciates the commenters not submit their works for registration will not be permitted.4 Each of these bringing these issues to our attention. under this permissive system, the public requirements is discussed below. The Office recognizes that secure tests record will not contain any information A. Eligibility Requirements serve an important societal function, concerning those works. This creates a and that providing a secure method for void in the record that diminishes the 1. Test Items That May Be Included in registering copyright claims in those value of the Office’s database. the Group tests furthers the public good. Although Allowing a number of related works To qualify for the GRSTQ option, all the June 12, 2017 interim rule was to be submitted on one application, the test items in the group must be aimed to better align secure test however, is not without its issues. When prepared for use in a secure test, as registration procedures with the Office’s large numbers of works are grouped defined in § 202.13(b)(1) of the earlier statutory obligations and general good together in one application, information interim rule. A database or test bank practices for copyright registration, the about the individual works may not be does not qualify as a ‘‘secure test’’ in Office also recognizes that the interim adequately captured. Group registration and of itself. But the Office recognizes rule did not provide secure test options, therefore, require careful that when test items are selected from publishers with a means for registering balancing of the need for an accurate a test bank and assembled together to individual test items that are stored in public record and the need for an form an actual secure test, they share a database or test bank without efficient method of facilitating the the same security concerns that disclosing the content of these works. examination of those works. prompted the Office to create the special To address these legitimate concerns, The new procedure will be known as accommodation for individual secure the Office has decided to issue another the ‘‘group registration option for secure tests. For this reason, test items that are interim rule as part of this rulemaking, test items’’ or ‘‘GRSTQ’’. The rule will prepared for use in a secure test will be and to make that rule effective allow a group of test items that are eligible for the GRSTQ option. immediately. derived from a test bank or database to For the purposes of registration, a A. Group Registration Generally be registered using the same basic ‘‘test item’’ is a question (or ‘‘stem’’), the This interim rule establishes a new procedure for registering an individual correct answer to that question, any group registration option for test items secure test.3 The test items must be incorrect answer choices (or prepared for use in a secure test. prepared for use in a ‘‘secure test,’’ as ‘‘distractors’’), and any associated When Congress enacted the Copyright defined in § 202.13(b)(1) of the earlier material, such as a narrative passage or Act, it authorized the Register to specify interim rule. And if certain diagram. A single narrative or diagram by regulation the administrative classes requirements have been met, the test followed by multiple related questions of works for the purpose of seeking a items may be registered by submitting a and correct and incorrect answers will registration and the nature of the redacted copy of the works and together be considered a single test item. deposit for each such class. Congress presenting an unredacted copy of these Under this interim rule, each test item also gave the Register the discretion to materials to the Office for an in-person will be considered one work. Thus, if an allow groups of related works to be examination. applicant submits one textual passage registered with one application and one Under this interim rule, each followed by a question and four answers filing fee. See 17 U.S.C. 408(c)(1). This individual test item may constitute one related to that passage, this would be procedure is known as group work if the item is determined to be considered one work for purposes of registration. Pursuant to this authority, copyrightable in itself. While there is no registration. A single narrative or the Office issued regulations creating limit to the number of test items that diagram followed by multiple sets of group registrations for certain limited may be included in each submission, related questions and answers will also categories of works, provided that each work must share certain traits. be considered one work. The Office certain conditions have been met. See Specifically, the test items contained in believes this definition will be broad generally 37 CFR 202.3(b)(1)–(10), a single group must all be either enough to encompass many different 202.4. published or unpublished. They must kinds of test items. It nonetheless As the legislative history explains, all be created by the same author or co- welcomes public comments on whether allowing ‘‘a number of related works to authors, and the copyright claimant(s) that definition could be clarified or be registered together as a group must be the same for each item. Because otherwise improved. represent[ed] a needed and important an overwhelming majority of secure 2. The Number of Test Items That May liberalization of the law.’’ H.R. Rep. No. tests are works made for hire, the Office Be Included in the Group 94–1476, at 154 (1976), reprinted in is considering whether to limit these Under this interim rule, the Office 1976 U.S.C.A.N.N. 5659, 5770; S. Rep. registrations to works made for hire, will allow an unlimited amount of No. 94–473, at 136 (1975). Congress although it did not include this works to be included with each group recognized that requiring applicants to restriction in this interim rule. The registration, and will examine each submit separate applications for certain Office welcomes public comments on individual test item for copyrightable types of works may be so burdensome whether this requirement should be authorship. Applicants should note, and expensive that authors and included in the final rule. copyright owners may forgo registration however, that an extremely large A group registration for secure test number of test items may take a altogether, since copyright registration items will cover each work in the group, is not a prerequisite to copyright i.e., each test item will be deemed to be 4 Because of the confusion surrounding the protection. Id. If copyright owners do registered as a separate work. Claims in treatment of test items stored in databases under the the selection, coordination, or June 12, 2017 interim rule, the Office intends to Office is not in a position to amend that regulatory arrangement of the group as a whole apply this interim rule to pending registration definition at this time, it acknowledges that the applications, but where applicable, the Office will administration of secure tests has changed in many request a revised application and deposit materials. ways since this definition was first promulgated in 3 To be clear, the interim rule issued on June 12, If these requirements are met, the Office will assign 1978, and it is continuing to consider those 2017 otherwise remains in effect, and may continue an effective date of registration based on the date comments that have asked the Office to update this to be used to register individual secure tests. 37 that the initial application and deposit were definition to account for these changes. CFR 202.13(b)(1). received.
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significant amount of time—in some Applicants must provide additional examples of acceptable redaction cases, several days—to examine. descriptive information in the title that, methods in the most recent version of Moreover, applicants will be required to at a minimum, identifies the name of Circular 64 (posted on the Office’s Web pay an hourly fee for the time spent the secure test that the items are site on November 13, 2017. examining these test items during the intended for. The title may also include The questionnaire and the redacted in-person appointment. any relevant dates. For example, copy containing all of the test items Over time, allowing an unlimited applicants can identify the specific test must be contained in separate electronic number of works to be registered with where the test items will be used (e.g. files, and they must be uploaded to the one application may reduce the quality ‘‘GRSTQ: Test items for February 2017 electronic registration system in of the registration record, or it may LSAT’’), the test bank or database from Portable Document Format (PDF). The impose an unreasonable administrative which the test items were derived (e.g. file name for the questionnaire should burden on the Office. Therefore, the ‘‘GRSTQ: Test items added to the include the word ‘‘Questionnaire’’ and Office will monitor this process for FINRA Series 7 Exam item bank in the the case number assigned to the claim. several months following the issuance 3rd quarter of 2017’’), or the subject (This eleven-digit number is of this interim rule, and will evaluate matter of the test items (e.g. ‘‘GRSTQ: automatically generated by the what effect, if any, allowing an SAT reading comprehension test electronic registration system, and it unlimited amount of tests items per items’’). appears near the top of each screen of registration may have on the Office’s 5. Author and Claimant the online application.) The file name business processes to determine for the redacted copy should match the whether the number should be limited Under this interim rule, all the test title provided on the questionnaire. under the final rule. items in the group must be authored by Once the application, filing fee, When completing the electronic the same person or organization. questionnaire and the redacted copy application, the applicant must Likewise, the copyright claimant(s) for have been received, the Office will reasonably identify the total number of each work must be the same person or assign the claim to a Literary Division test items that are included in the organization. If the author(s) and examiner who will examine the claim in application. The applicant should claimant(s) are different, the application the date order of the Literary Division’s provide this information on the must contain an appropriate transfer pending overall workload. The questionnaire and by numbering each statement explaining how the claimant examiner will review these items to test item that appears in the deposit. obtained all of the exclusive rights in determine if the works appear to be The Office will use this information to the works. eligible for the GRSTQ option. If so, the plan for the in-person examination. B. The Application Process examiner will contact the applicant and Numbering the test items will also help schedule an in-person appointment to The application process described in the Office identify and examine the examine the works under secure this interim rule is essentially identical relevant works in the deposit. conditions. The fact that the examiner to the process described in the interim schedules an appointment, however, 3. Publication rule announced on June 12, 2017. See 82 FR 26852–53. To register a group of does not necessarily mean that the test Under this interim rule, an applicant items are eligible for the GRSTQ option will be allowed to register a group of test items, applicants must complete and submit an application through the or that they will be registered. As unpublished test items, or a group of discussed below, the in-person test items that are published within a electronic registration system using the Standard Application, and they must examination may reveal that individual three-calendar-month period. test items or the group as a whole is Applicants will not be allowed to pay the $55 filing fee. Prior to scheduling an examination ineligible for registration under these combine published and unpublished procedures or in general.5 test items in the same claim. appointment, applicants must complete If an applicant submits a group of and upload a brief questionnaire about C. The In-Person Examination published test items, and if the items the test items, which may be obtained On the day of the in-person were published on the same date, the from the Office’s Web site at https:// examination appointment, the applicant applicant should provide that date in www.copyright.gov/forms/securetest- must bring the following materials to the application. If the test items were questionnaire.pdf, and they must the Office: published on different dates, the upload a redacted copy of all the test (i) A copy of the completed applicant must identify the first date items being registered. The Office will application. that the items were published. Claims use this information to determine if the (ii) The nonrefundable examination with a range of publication dates works are eligible for the GRSTQ option. fee.6 This fee will be based on the outside of a three-calendar–month The copy uploaded to the electronic amount of time that it takes to examine period will be refused. registration system should contain a each item during the in-person redacted copy of each test item, and, as 4. Title of the Group appointment; it is in addition to the mentioned above, each test item should filing fee mentioned above. Both the To register a group of test items be numbered. Most of the content that prepared for use in a secure test, the appears on each page may be blocked 5 If the examiner determines that the test items are applicant must provide a title for the out, provided that the redacted copy not eligible for registration under secure test group as a whole. In addition, the contains a sufficient amount of visible procedures, but are eligible under normal (i.e., non- applicant must append the term content that may be used to identify secure test) examination procedures, the examiner will ask the applicant to upload a complete ‘‘GRSTQ’’ at the beginning of the title of each item. For instance, the applicant unredacted copy of the items, and he or she will the group, so that the Office can more may leave a narrow vertical or diagonal change the effective date of registration to match the easily assign the claim to an appropriate strip of visible content across each page. date that the unredacted copy is received. member of the Registration Program. Alternatively, the applicant may redact 6 The Office will charge the same hourly examination rate regardless of whether an applicant Upon request, the examiner will remove the content of each test item, except for is seeking to register a secure test or a group of test this term from the title field before the a small number of identifiable words. items prepared for use in a secure test. See 37 CFR claim is approved. The Office has provided representative 201.3(d)(5).
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filing fee and the examination fee are requirements for this group registration providing a redacted copy for the nonrefundable, regardless of whether option. The registration will be effective Office’s records are consistent with the the Office issues a certificate of as of the date that the Office originally Office’s longstanding practices for registration for the test items. received the application, filing fee, and examining secure tests. (iii) A copy of the redacted test items the redacted copy that was uploaded to Finally, issuing the rule on an interim that were uploaded to the electronic the electronic registration system. basis affords both the Office and registration system. D. The Scope of Registration interested parties an opportunity to (iv) A signed declaration confirming evaluate how these procedures work in that this redacted copy is identical to Under this interim rule, a group conjunction with the procedures the redacted copy that was uploaded to registration will cover each test item in announced in the June 12, 2017 interim the electronic registration system. the group, and each test item will be rule, to determine whether these Applicants may obtain a copy of this registered as a separate work. See 37 procedures should be modified in any declaration from the Office’s Web site at CFR 202.4(m). The group is merely an respect, and whether the number of test https://www.copyright.gov/forms/ administrative classification created items that may be included in each securetest-declaration.pdf. solely for the purpose of registering claim should be adjusted before the (v) An unredacted copy of the test multiple works with one application Office issues a final rule. See 5 U.S.C. items submitted for registration. and one filing fee. See 17 U.S.C. 553(b)(3)(B). Applicants must bring a copy of the 408(c)(1) (‘‘Th[e] administrative unredacted test items, with the entire classification of works has no List of Subjects in 37 CFR Part 202 content completely visible so that they significance with respect to the subject Copyright, Preregistration and may be examined. The test items in the matter of copyright or the exclusive registration of claims to copyright. unredacted copy should be numbered, rights provided by this title.’’). should appear in the same order as the Therefore, the Office will not consider Interim Regulation redacted copy, and should precisely the group as a whole to be a compilation In consideration of the foregoing, the match the test items as they appear in or a collective work under sections 101, U.S. Copyright Office amends 37 CFR the redacted copy. 103(b), or 504(c)(1) of the Copyright Act. part 202 as follows: The examiner will review the By contrast, when an applicant registers redacted and unredacted copies in a a secure test under the June 12, 2017 PART 202—PREREGISTRATION AND secure location in the presence of the interim rule, the applicant must assert a REGISTRATION OF CLAIMS TO applicant or the applicant’s claim in the test as a whole, or in the COPYRIGHT representative. Because the Office will individual test items and the selection, examine each test item for copyrightable coordination, and/or arrangement of ■ 1. The authority citation for part 202 authorship, and because the Office is those items. See 86 FR at 26852. continues to read as follows: not currently placing a limit on the Authority: 17 U.S.C. 408(f), 702. number of items, the examination may IV. Request for Comments ■ 2. Amend § 202.4 as follows: require more time and may result in a This interim rule will go into effect ■ a. Revise paragraph (b). higher total examination fee than an immediately upon the publication of ■ b. Redesignate paragraphs (k) through examination involving an individual this document in the Federal Register. (m) as paragraphs (l) through (n), secure test. If the examiner determines As was the case with the June 12, 2017 respectively. that one or more of the test items are not interim rule, this is a non-substantive ■ c. Add new paragraph (k). copyrightable, he or she will require the rule that is not subject to the restriction ■ d. In newly redesignated paragraph applicant to exclude that material from in 5 U.S.C. 553(d). See 82 FR 26853. In (n), remove ‘‘paragraph (g)’’ and add in the claim in order to continue the addition, there is ‘‘good cause’’ for this its place ‘‘paragraph (g) or (k)’’. examination, or will refuse the claim rule to go into immediate effect because The revision and addition read as altogether. Face-to-face disputes with it restores to secure test publishers a follows: the examiner about the sufficient method of registering test items that creativity of an item will not be allowed existed prior to the issuance of the June § 202.4 Group registration. and will result in refusal of the claim. 12, 2017 interim rule but was not * * * * * If an applicant does not agree that an provided under that rule. See 5 U.S.C. (b) Definitions. For purposes of this individual test item should be excluded, 553(d)(3). And, finally, the Copyright section, unless otherwise specified, the the applicant may seek to register that Office prepared this interim rule based terms used have the meanings set forth test item or test items alone and appeal upon its experience in administering in §§ 202.3, 202.13, and 202.20. the subsequent refusal. other group registrations, and its review * * * * * When the examination is complete, of comments received in response to the (k) Secure test items. Pursuant to the the examiner(s) will stamp the date of June 12, 2017 interim rule. authority granted by 17 U.S.C. 408(c)(1), the appointment on the redacted and Comments will be due on December the Register of Copyrights has unredacted copies and will return them 11, 2017 (the same deadline for determined that a group of test items to the applicant. The signed declaration submitting comments on the June 12, may be registered in Class TX with one and the redacted copy that was 2017 interim rule). The Office decided application, one filing fee, and uploaded to the electronic system will to issue this rule without publishing an identifying material, if the conditions be retained by the Office; this redacted initial notice of proposed rulemaking for set forth in § 202.13(c) and (d) have been copy will constitute the deposit. several reasons: If the examiner determines that the First, the interim rule addresses met. legal and formal requirements have been concerns expressed by interested parties * * * * * met, he or she will register the claim(s) in comments filed in response to the ■ 3. Amend § 202.13 as follows: and will add an annotation to the earlier interim rule on secure tests. ■ a. Revise paragraph (a). certificate indicating that the test items Second, the procedures for scheduling ■ b. Add paragraph (b)(5). were registered under this interim rule an in-person appointment, submitting ■ c. Revise paragraphs (c) introductory in accordance with the eligibility an unredacted copy of the works, and text and (c)(2).
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■ d. Remove paragraph (c)(3). (iii) A copy of the redacted version of DEPARTMENT OF TRANSPORTATION ■ e. Redesignate paragraphs (c)(4) and the work(s) that was uploaded to the (5) as paragraphs (c)(3) and (4), electronic registration system. Office of the Secretary respectively. (iv) A signed declaration confirming 49 CFR Part 40 ■ f. Revise newly redesignated that the redacted copy specified in paragraphs (c)(3)(iii), (iv), and (v) and paragraph (c)(3)(iii) of this section is [Docket DOT–OST–2016–0189] the first sentence in newly redesignated identical to the redacted copy that was RIN 2105–AE58 paragraph (c)(4). uploaded to the electronic registration ■ g. Add paragraph (d). system. Procedures for Transportation The additions and revisions read as (v) In the case of a secure test, the Workplace Drug and Alcohol Testing follows: applicant must bring an unredacted Programs: Addition of Certain Schedule II Drugs to the Department of § 202.13 Secure tests. copy of the entire test. In the case of a Transportation’s Drug-Testing Panel group of test items prepared for use in (a) General. This section prescribes and Certain Minor Amendments rules pertaining to the registration of a secure test, the applicant must bring secure tests or a group of test items an unredacted copy of all the test items. AGENCY: Office of the Secretary of prepared for use in a secure test. (4) The Copyright Office will examine Transportation (OST), U.S. Department (b) * * * the copies specified in paragraphs of Transportation (DOT). (5) A test item is comprised of a (c)(3)(iii) and (v) of this section in the ACTION: Final rule. question (or ‘‘stem’’), the correct answer applicant’s presence. * * * SUMMARY: The Department of to that question, any incorrect answer (d) Group registration requirements. Transportation is amending its drug- choices (or ‘‘distractors’’), and any The Copyright Office may register a testing program regulation to add associated material, such as a narrative group of test items if the following hydrocodone, hydromorphone, passage or diagram, and each item shall conditions have been met: oxymorphone, and oxycodone to its be considered one work. A single drug-testing panel; add narrative, diagram, or other prefatory (1) All the test items must be prepared for use in a secure test, and the name methylenedioxyamphetamine as an material, followed by multiple sets of initial test analyte; and remove of the secure test must be identified in related questions and correct or methylenedioxyethylamphetamine as a the title of the group. incorrect answers shall together be confirmatory test analyte. The revision considered one item. (2) The group may contain an of the drug-testing panel harmonizes (c) Deposit requirements. Pursuant to unlimited amount of works, but the DOT regulations with the revised HHS the authority granted by 17 U.S.C. applicant must identify the individual Mandatory Guidelines established by 408(c)(1), the Register of Copyrights has works included within the group by the U.S. Department of Health and determined that a secure test or a group numbering each test item in the deposit. Human Services for Federal drug-testing of test items prepared for use in a secure (3) The applicant must provide a title programs for urine testing. This final test may be registered with identifying for the group as a whole, and must rule clarifies certain existing drug- material, and the filing and examination testing program provisions and fees required by § 201.3(c) and (d), if the append the term ‘‘GRSTQ’’ to the beginning of the title. definitions, makes technical following conditions are met: amendments, and removes the * * * * * (4) The group must contain only requirement for employers and (2) In the case of a secure test, the unpublished works, or works published Consortium/Third Party Administrators applicant must submit a redacted copy within the same three-calendar-month to submit blind specimens. of the entire test. In the case of a group period and the application must identify DATES: This rule is effective on January of test items prepared for use in a secure the earliest date that the works were 1, 2018. test, the applicant must submit a published. FOR FURTHER INFORMATION CONTACT: redacted copy of each test item. In all (5) All the works in the group must Patrice M. Kelly, Acting Director, Office cases the redacted copy must contain a have the same author or authors, and of Drug and Alcohol Policy and sufficient amount of visible content to the copyright claimant for each work Compliance, 1200 New Jersey Avenue reasonably identify the work(s). In must be the same. Claims in the SE., Washington, DC 20590; telephone addition, the applicant must complete selection, coordination, or arrangement number 202–366–3784; and submit the secure test questionnaire of the group as a whole will not be [email protected]. that is posted on the Copyright Office’s permitted on the application. Each item SUPPLEMENTARY INFORMATION: Web site. The questionnaire and the in the group must be separately redacted copy must be contained in I. Purpose copyrightable or must be excluded from separate electronic files, and each file the group. The Department of Transportation must be uploaded to the electronic (DOT or the Department) issued a notice registration system in Portable Dated: November 6, 2017. of proposed rulemaking (NPRM) on Document Format (PDF). The Copyright Karyn Temple Claggett, January 23, 2017. 82 FR 7771 (Jan. 23, Office will review these materials to Acting Register of Copyrights and Director 2017). The NPRM proposed to revise determine if the work(s) qualify for an of the U.S. Copyright Office. Part 40 of Title 49 of the Code of Federal in-person examination. If they appear to Approved by: Regulations (CFR) to harmonize with be eligible, the Copyright Office will certain parts of the revised the contact the applicant to schedule an Carla D. Hayden, Department of Health and Human appointment to examine an unredacted Librarian of Congress. Services (HHS) Mandatory Guidelines copy of the work(s) under secure [FR Doc. 2017–24532 Filed 11–9–17; 8:45 am] for Federal Workplace Drug Testing conditions. BILLING CODE 1410–30–P Programs using Urine (HHS Mandatory (3) * * * Guidelines), which was published on
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the same day. 82 FR 7920 (Jan. 23, regulated programs, we must follow the Changes Relevant to the HHS 2017). DOT currently requires urine HHS Mandatory Guidelines for the Mandatory Guidelines testing for safety-sensitive categories of drugs for which we will HHS monitors drug abuse trends and transportation industry employees require testing. reviews information on new drugs of subject to drug testing under Part 40. III. Background abuse from sources such as Federal There are two changes to the HHS regulators, researchers, the drug-testing Mandatory Guidelines with which the Relevant History of the DOT Drug- industry, and public and private sector NPRM proposed to harmonize Part 40. Testing Program Regulation employers. In its May 15, 2015 ‘‘Notice First, the revised HHS Mandatory The Department first published its of Proposed Revisions’’ (See 80 FR Guidelines, in part, allow Federal 28103), HHS indicated that, since its agencies with drug-testing drug testing program regulation, 49 CFR part 40 (Part 40) on November 21, 1988 original HHS Mandatory Guidelines responsibilities to test for four were published in 1988, a number of as an interim final rule (53 FR 47002). additional Controlled Substances Act recommendations had been made for We based the rule on the HHS (CSA) Schedule II prescription additional drugs to be included in Mandatory Guidelines for Federal medications: Hydrocodone, Federal workplace drug-testing Workplace Drug Testing Programs (See hydromorphone, oxycodone, and programs. According to HHS, 53 FR 11970, April 11, 1988), which, in oxymorphone. Second, the HHS recommendations for adding the four part, required cocaine and marijuana to Mandatory Guidelines remove semi-synthetic drugs were based on a be screened by Federal agencies. HHS methylenedioxyethylamphetamine review of scientific information and on based this requirement on the incidence (MDEA) as a confirmatory test analyte input from the Drug Testing Advisory and prevalence of the abuse of these two from the existing drug-testing panel and Board (DTAB) 1 on the methods substances in the general population add methylenedioxyamphetamine necessary to detect the analytes of drugs (MDA) as an initial test analyte. In and on the experiences, at the time, of and on drug abuse trends. With the addition to harmonizing with pertinent the Departments of Defense and DTAB recommendations, private sector sections of the HHS Mandatory Transportation in screening their experience findings, and analysis of Guidelines for urine testing, the NPRM workforces (53 FR 11973–11974). The current drug abuse trends, HHS proposed to clarify certain existing Part 1988 HHS Mandatory Guidelines also concluded that the additional semi- 40 provisions; to remove provisions that authorized Federal agencies to test their synthetic opioids, oxycodone, no longer are necessary (such as employees for the use of phencyclidine, oxymorphone, hydrocodone, and obsolete compliance dates); to move the amphetamines, and opiates. The DOT hydromorphone, should be added in the content of certain provisions out of Part published a final rule on December 1, Federal program. 40 and onto the Office of Drug and 1989 (54 FR 49854), which incorporated In its Final Rule dated January 23, Alcohol Policy and Compliance’s several provisions from the 1988 HHS 2017, HHS acknowledged that, while it (ODAPC) Web site; and to update Mandatory Guidelines. Among these had proposed MDA and MDEA as initial definitions and web links where provisions was a 5-panel test that test analytes, three commenters necessary. The Department also included all of the drugs for which HHS disagreed with the addition of MDA and proposed to remove existing Part 40 authorized testing. In 1991, Congress MDEA as target analytes. HHS indicated requirements related to blind specimen passed the Omnibus Transportation that the commenters stated that this testing. Employee Testing Act (OTETA) which, change would require modification of The Department received 69 in part, required the Department and current immunoassay reagents, comments on the proposed rulemaking. DOT Agencies to look to the HHS for the laboratory processes, or both. The The comments were from multiple scientific and technical guidelines commenters noted that this would sources including transportation regarding the drugs for which we test impose an unnecessary burden for industry associations, drug and alcohol and specimens we collect. compounds with such low incidence in testing industry companies and The Department made comprehensive workplace testing. HHS determined that associations, doctors and medical revisions to Part 40 on August 19, 1994 the number of positive MDEA groups, labor organizations, and (59 FR 42996), December 19, 2000 (65 specimens reported by HHS-certified individuals. FR 79462), and August 16, 2010 (75 FR laboratories does not support testing all II. Authority for This Rulemaking 49850). The 2010 revision again specimens for MDEA in Federal This rule is promulgated pursuant to harmonized our DOT drug-testing workplace drug testing programs. Based the Omnibus Transportation Employee program, where necessary, with the on the comments and its own studies, Testing Act (OTETA) of 1991 (Pub. L. HHS Mandatory Guidelines effective HHS removed MDEA from its Mandatory Guidelines. HHS indicated 102–143, Title V, 105 Stat. 952). OTETA October 1, 2010 (73 FR 7185; 75 FR that it understands MDA and some sets forth the requirements for DOT 22809). Specifically, we required initial other analytes also have a low incidence reliance on the HHS Mandatory and confirmatory testing for of testing positive, but believes the Guidelines for scientific testing issues. methylenedioxymethamphetamine continued testing for these analytes is Section 503 of the Supplemental (MDMA); confirmatory testing for MDA warranted in a deterrent program. In Appropriations Act, 1987 (Pub. L. 100– and MDEA; and initial testing for 6- particular, inclusion of MDA as an 71, 101 Stat 391, 468), 5 U.S.C. 7301, acetylmorphine (6–AM). We also initial and confirmatory test analyte is and Executive Order 12564 establish lowered the initial and confirmatory test warranted according to HHS because, in HHS as the agency that directs scientific cutoff concentrations for amphetamines and technical guidelines for Federal and cocaine. 1 The Drug Testing Advisory Board provides workplace drug-testing programs and Just as we have revised Part 40 in the advice to HHS (the Administrator of SAMHSA) standards for certification of laboratories past, we are revising Part 40 to based on an ongoing review of the direction, scope, engaged in such drug testing. While harmonize, in pertinent part, with the balance, and emphasis of the Agency’s drug-testing activities and the drug testing laboratory DOT has discretion concerning many most recently revised HHS Mandatory certification program. See http://www.samhsa.gov/ aspects of the regulations governing Guidelines that have an effective date of about-us/advisory-councils/drug-testing-advisory- testing in the transportation industries’ October 1, 2017. See 82 FR 7920. board-dtab/board-charter.
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addition to being a drug of abuse, it is synthetic opioids to the DOT testing Mandatory Guidelines or to change the a metabolite of MDEA and MDMA. panel. Of those comments, 41 supported cutoff levels that HHS has established. the NPRM’s proposal. Supporters Furthermore, HHS conducted a full Harmonizing Changes to the DOT Drug- generally recognized the need for the notice and comment period regarding Testing Program Regulation Department to act consistently with the these aspects of the HHS Mandatory In keeping with our obligations under HHS Mandatory Guidelines and agreed Guidelines and that time would have OTETA to follow the HHS Mandatory that addressing opioid abuse issues in been the appropriate point for Guidelines for the drugs for which we the context of transportation safety is commenters to request HHS to consider test, our NPRM proposed to add and important. Of the other 11 comments, their concerns. To further ensure that remove the drugs adopted in the revised several expressed concerns that adding our regulated public was kept informed HHS Mandatory Guidelines for urine these substances would increase about this opportunity to comment on testing. Inclusion of these four semi- circumstances in which drivers HHS rulemakings that could potentially synthetic opioids is intended to help innocently using opioids (e.g., via a affect them, on May 15 and 19, 2015, address the nation-wide epidemic of prescription for pain medication) would ODAPC sent notices to the ODAPC list- opioid abuse. Also, adding these four be unfairly treated as drug abusers, with serve informing subscribers about the drugs, which are already tested for in consequent positive tests harming their HHS proposal so that interested parties many transportation employers’ non- careers. A few comments suggested could submit comments to the HHS DOT testing programs because of their adding other substances, such as docket. See http:// widespread use and potentially methadone or synthetic cannabinoids, content.govdelivery.com/accounts/ impairing effect, will allow the DOT to to the panel. USDOT/bulletins/1047858 and http:// detect a broader range of drugs being Other commenters, including some content.govdelivery.com/accounts/ used illegally. This will enhance the labor organizations, were concerned that USDOT/bulletins/1051d3e. Once HHS safety of the transportation industries employees would have to compromise reaches a final determination on the and the public they serve. The their medical privacy in order to avoid drugs and their cutoff levels, the DOT Department’s final rule makes these results being verified positive by cannot depart from HHS’s decisions on harmonizing amendments to Part 40. medical review officers (MROs). One these matters. comment suggested raising the cutoff Similarly, DOT does not have the IV. Main Policy Issues levels to make it less likely that an authority to add substances such as employee using a legitimate A. Modification of the Drug Testing methadone or synthetic cannabinoids to Panel prescription medication would receive a positive laboratory result. Other our drug testing panel without the The NPRM comments raised concerns about how scientific and technical expertise of the The Department proposed to add the adding these opioids to the testing panel HHS, as expressed in the HHS four semi-synthetic opioids to the DOT would impact other aspects of Part 40, Mandatory Guidelines. In addition, HHS panel (i.e., hydrocodone, such as MRO determinations about is limited to testing for drugs under hydromorphone, oxycodone, and whether a prescription is legitimate or Schedules I and II of the CSA. Parties oxymorphone) to maintain consistency when it is appropriate for an MRO to interested in having additional drugs in with the HHS Mandatory Guidelines. inform an employer of a safety concern those CSA Schedules tested as part of Such consistency is mandated by after verifying a negative result based on the Federal or DOT program should Federal statute, OTETA, and applies not an employee’s legitimate use of discuss the matter with HHS. only to the drugs tested but also to prescription medication. Other The Department received comments specimen testing validity values and comments recommended additional regarding the relationship between the initial and confirmatory testing values. rules or guidance concerning MRO Department’s drug panel and the HHS To cover these substances, as well as practice, such as additional opioids Mandatory Guidelines during past those previously in the opiate category training and directing MROs not to rulemaking activities. The Department’s (i.e., codeine, morphine, 6–AM), the second-guess the prescription position, described above, affirms its NPRM proposed to rename the category judgments of an employee’s physician. past responses. (See 75 FR 49850, 49850–49853). from ‘‘opiates’’ to ‘‘opioids.’’ DOT Response As we mentioned in the NPRM In other sections of this preamble, the preamble, opioid abuse and related We acknowledge the 41 comments Department will discuss comments problems are a major national concern. that supported adding the four semi- related to MRO practice issues that Transportation industries are not synthetic opiates to the DOT drug could arise when the four new semi- immune to this trend and the safety testing panel. We agree that this is an synthetic opioids in our testing panel issues it raises. Consequently, the important safety improvement. In are introduced. Examples of these issues Department proposed including these addition, we appreciate that so many include an employee’s medical privacy, substances in its testing panel not only commenters recognized that we must legitimacy of prescriptions, MROs not for consistency with the HHS follow the HHS Mandatory Guidelines questioning the treating physician’s Mandatory Guidelines but as a response for the drugs for which we test. prescription judgment, and safety to a national problem that can affect Although a commenter suggested concerns. transportation safety. adding other substances and raising the In addition, to be consistent with HHS established cut-off levels, we are B. Blind Specimens changes to the HHS Mandatory not permitted to make such changes. As The NPRM Guidelines, the Department proposed to noted above, OTETA requires the remove MDEA from the testing panel Department to conform with the HHS The NPRM proposed to remove from and add MDA as an initial test analyte. Mandatory Guidelines with respect to Part 40 the requirements for blind the drugs for which we test and their specimen testing. The purpose of this Comments cutoff levels. The Department does not proposal was to relieve unnecessary There were 52 comments addressing have the discretion to decline to include costs and administrative burdens on the addition of the specified semi- drugs that are included in the HHS employers, C/TPAs, and other parties.
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The blind specimen requirement has Opponents of removing the specimen tests now required has been been part of the Department’s drug requirement, including labor eliminated. testing program since its inception. The organizations and some laboratory- While commenters who favor requirement for employers and C/TPAs related entities, made several retaining the requirement expressed to submit blinds was intended to help arguments. More than one commenter concern about the possibility of false ensure the accuracy of the laboratory stated that, while the Department may negatives, or the potential loss of a testing process. Under the current not have been aware of any false deterrent effect on laboratories by regulation, an employer will send a positives resulting from blind specimen eliminating blind specimen testing, blind specimen to an HHS-certified tests, there was no information these concerns are speculative. None of laboratory, accompanied by a Federal presented about the incidence of false the laboratories or blind specimen Drug Testing Custody and Control Form negatives. False negatives, they said, manufacturers who commented (CCF) with the name of a fictitious could be as damaging to the integrity provided data to support any assertions donor, for quality control purposes to and safety objectives of the drug testing of false negatives. Without data to see if the laboratory’s results match the programs as false positives. Some support these assertions, the known contents of that particular blind commenters said the existence of blind Department has no basis on which to specimen. specimen testing could provide an substantiate that there are false Over the years, as the accuracy of the incentive to laboratories to maintain the negatives indicative of systemic laboratory testing process was accuracy of their procedures, somewhat laboratory problems. Instead of consistently established, DOT reduced analogous to the deterrent effect of identifying laboratory problems, false the number of blind specimens that random testing on employee behavior. negatives, if they exist, could be employers were required to send to In its absence, laboratories might relax attributed to problems with the laboratories to reduce cost and their standards. Other commenters said manufacture of the blind specimens or administrative burdens associated with that, even if blind specimen testing did employers and C/TPAs not adhering to the process. As we stated in the NPRM, not reveal any false positives, the the manufacturer’s instructions on the not one false positive result was found existence of the process of blind use or expiration date of their product. through the testing of the blind specimens added to, or at least The Department retention of the blind specimens in more than 25 years of drug increased the appearance of, fairness to specimen testing requirement would testing. employees. exacerbate, not reduce, those problems. In addition, some commenters noted The Department and the As the NPRM noted, laboratories are that because laboratories will begin subject to thorough biannual transportation industries rely upon the testing for new substances proposed NLCP certification and oversight inspections and quarterly proficiency under the NPRM (i.e., the semi- testing through the HHS National processes, as well as the split specimen synthetic opioids), it would be useful to testing process, to ensure that the Laboratory Certification Program maintain blind specimen testing to help (NLCP). In addition, if an employee has accuracy of the laboratory testing is up to ensure that errors did not occur in the to NLCP certification standards. In questions about the accuracy of the testing of these newly added drugs. positive, adulterated, or substituted test OTETA, Congress directed the Also, some of the commenters believed Department to rely on HHS-certified result of his or her own specimen, the that it would be better to keep blind employee has the right to request the laboratories, without any reference to specimen testing in place as a safeguard, the additional process of blind test of his or her split specimen. as opposed to relying wholly on split Believing that the blind specimen specimen testing. Moreover, there have specimens and the NLCP. One been no false positive results for blind testing requirement was no longer commenter noted that NLCP’s oversight necessary to ensure the accuracy and specimens reported to the Department, of laboratories could be weakened by as required by the current Part 40, either integrity of the testing process, we future decreases in HHS budgets and proposed eliminating this requirement before or after the NPRM was issued. this could lead to the reduction of the The Department will continue to rely on and sought public comment on the effectiveness of that program. subject. HHS for laboratory certification because DOT Response now more than 25 years of blind Comments The history of the blind specimen specimen testing has shown that there Twenty-five comments addressed this testing requirement shows decreasing have been no false positive blind proposal. Fifteen supported removing reliance on this process as a safeguard. specimen results. the requirement, while ten asked to Laboratories have accumulated a record Given the rigorous HHS oversight of retain it. Proponents of removal, of accuracy spanning more than 25 the laboratories, as well as the business principally some testing industry years. Years ago, the DOT reduced the necessity for the laboratories to associations and employer groups, amount of blind specimen testing from maintain a reliable record of accuracy, generally agreed that there were three percent to one percent, with no it is not likely that laboratories would sufficient safeguards on the accuracy known ill effects on the integrity of the relax their standards simply because the and integrity of the system and that process. relatively small number of blind blind specimens were unnecessary. We disagree with the commenters specimen tests now required was They commented that it was, who implied that elimination of the eliminated. Consequently, the consequently, a good idea to eliminate blind specimen testing would cause Department is adopting its proposal to the costs and burdens associated with laboratories to change the way they do remove blind specimen testing the requirement. They said that the business and, thereby lower their requirements from part 40. accuracy and integrity of the system will standards. Given the continuing C. The DOT List-Serve not be compromised by eliminating rigorous HHS oversight and the business blind specimen testing. One employer necessity of maintaining accuracy, it is The NPRM association noted that the requirement not likely that laboratories would relax The NPRM proposed requiring key only affected the largest companies in their standards simply because the personnel in the drug and alcohol its industry, and not small businesses. relatively small number of blind testing process—collectors, Breath
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Alcohol Technicians (BATs), Screening and encouraging their members to take timely information into the hands of the Test Technicians (STTs), Medical advantage of it. We want to extend our specified service agents, and would Review Officers (MROs), Substance gratitude to all who have spread the demonstrate the DOT’s commitment to Abuse Professionals (SAPs)—to word about the usefulness of the list- making information available subscribe to the Office of Drug and serve and to the more than 40,000 electronically. Alcohol Policy and Compliance subscribers. Even when a service agent subscribes (ODAPC) list-serve. That list-serve is a As noted in the NPRM, we believe to the list-serve, it is a best business very useful source of information for: that the cost and burdens of additional practice for that service agent to keep a The DOT drug and alcohol testing rules drug and alcohol program workers paper copy of Part 40 and applicable and programs; guidance for handling subscribing to the list-serve would guidelines for easy reference and for issues that have arisen in the likely be minimal, and that there would when electronic retrieval of these implementation of the program; relevant be benefits to everyone receiving the documents is not possible. Certainly, antidrug information from Federal useful information it contains. While service agents can view these partners; and updates concerning the some commenters expressed concern documents on-line at ODAPC’s Web program. Subscriptions are free to users. about potential costs, we note that the site, but Internet accessibility is not Currently, there are more than 40,000 service is free. Reading information on always possible, especially during ODAPC list-serve subscribers. the list-serve is unlikely to be time- transportation operations in remote consuming and no different than if the Comments areas. service agent were to receive the While we would welcome the Everyone who commented thought information from a different source. subscription to the list-serve by that the list-serve is a very useful tool Signing up for the list-serve merely management personnel, it would not that many of them subscribe to and requires one to enter one’s email make sense to put the requirement of a support. Nine of the 13 comments on address on the Office of Drug and list-serve subscription upon the this proposal expressed full or qualified Alcohol Policy and Compliance’s Web collection site supervisor or other support for the proposal to make the page at www.transportation.gov/odapc. management personnel because they are ODAPC list-serve mandatory for key No comments attempted to provide data not necessarily the individuals persons who have currency regarding potential costs. responsible for complying with the requirements included in their part 40 Since the plain language rewrite of 49 qualification requirement under the qualification requirements. Opponents CFR part 40, 65 FR 79462 (December 19, existing Part 40 to remain current in his of requiring subscription to the list- 2000), collectors, MROs and SAPs have or her knowledge. A collector/BAT/ serve said that the proposed change was been required to ‘‘keep current on any STT/MRO or SAP is the individual with unnecessarily prescriptive and could changes to . . . [the applicable the requirement for training, remaining impose compliance costs (e.g., time regulations and guidelines].’’ This current and maintaining his or her own spent signing up and reading the applies to collectors in § 40.33(a); documentation. material) that were not considered in Medical Review Officers (MROs) in The Department disagrees with the the regulatory evaluation. One § 40.151(b)(3); Substance Abuse comment that subscribing to the list- commenter stated that subscribing to the Professionals (SAPs) in § 40.281(b)(3) serve serves no safety purpose. Over the list-serve served no safety purpose. In [SAPs]. Similarly; § 40.213(a) requires years, we have used the list-serve to addition, they asked how the Breath Alcohol Technicians (BATs) and inform the DOT-regulated industry requirement could be monitored, Screening Test Technicians (STTs) to about various important program-related documented, or enforced. One ‘‘be knowledgeable about the alcohol information. For example, list-serves commenter offered that the proposal testing procedures in this part and the have included: Public Interest Exclusion would work better as a ‘‘best practice’’ current DOT guidance.’’ decisions against fake MROs; changes to DOT agency auditors, inspectors and than a mandate. Some commenters the Federal Drug Testing Custody and investigators who inspect the service supported the proposal because of the Control Form (CCF) and authorization agents listed above currently ask the useful information the list-serve for use of the electronic CCF (eCCF); individual collector/BAT/STT/MRO or provides, but had questions and updated guidance documents such as: SAP whether that individual is current concerns about its implementation. One The Urine Specimen Collector on 49 CFR part 40 and the applicable commenter suggested that supervisors of Guidelines; What Employers Need to BATs, STTs, and collectors should be guidelines, to ensure the requirements for currency are met. The individual Know About DOT Drug and Alcohol required to subscribe instead of the Testing; FAA’s Designated Employer BATs, STTs, and collectors themselves. service agent would need to produce a 101-page copy of 49 CFR part 40 and the Representative videos; FTA’s Annual This commenter believed that their National Drug and Alcohol Conference; supervisors should make sure that they applicable guidelines in hard copy. After the list-serve requirement becomes Official ODAPC Interpretations of Part learned relevant information conveyed 40; and the FMCSA’s National Drug and by the list-serve. Another supporter of effective, the individual service agent may demonstrate currency by showing Alcohol Testing Clearinghouse. Each of the proposal was concerned that these notices touched on topics directly monitoring staff members’ compliance the most recent list-serve—most likely by displaying it on the service agent’s related to the DOT’s drug and alcohol could be burdensome for parties like C/ testing program. The list-serves TPAs. Another expressed concern about smart phone or other computer. Proving one’s subscription to the list-serve will communicate information that is related how the mandate would work given, the to the integrity and safety aspect of the rapid turnover of collectors and BATs. show the DOT auditor/inspector/ investigator that the individual is program. DOT Response subscribed to a system that provides an D. MRO Practice Issues The Department is appreciative that opportunity to stay current with the the commenters recognized the value of latest information about the program. The NPRM the list-serve, and that a number of Unequivocally, this would be a cost The NPRM proposed to amend industry organizations expressed their savings, would help to improve existing § 40.141(b) to say that commitment to publicizing the service compliance by getting the relevant and ‘‘prescription,’’ for purposes of MRO
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verification determinations, means ‘‘a Another comment suggested making the received specific training concerning legally valid prescription under the testing for D,L stereoisomers of the semi-synthetic opioids. This Controlled Substances Act [CSA].’’ This amphetamine and methamphetamine commenter also asked that legal review same language was used in § 40.135(e), mandatory in all methamphetamine of MRO decisions be permitted under in the context of informing third parties positives to avoid delays in reporting the regulations and that MROs and about potential safety implications of an final verification results to employers. collectors themselves be subject to drug employee’s use of a controlled With respect to the definition of testing. substance. The intent of the proposal ‘‘prescription,’’ eight of the nine Another area of comment focused was to harmonize the language of these commenters supported the NPRM. The upon the provision of § 40.327(a) that sections for clarity and consistency. ninth suggested that this was a matter directs MROs to report to employers and It has always been the intent of this better left to medical organizations. third parties when safety concerns program to follow the CSA regarding Another commenter suggested that the remain after a non-negative test what constitutes a legally valid rule specify that there could never be a laboratory-confirmed result is prescription. The term ‘‘prescription’’ legally valid prescription for marijuana, downgraded to a negative due to the has become more loosely used in recent to reinforce that state ‘‘medical existence of a prescription. Some years. Under the Internal Revenue Code, marijuana’’ laws do not have validity for commenters believed that the individuals can be reimbursed for over- the purposes of the DOT program, downgraded non-negative results are the-counter medications and some which is bound to follow Federal law. still likely to result in the medical services, if the taxpayer has a One commenter specifically noted that disqualification of the employee ‘‘prescription’’ from their doctors for the word ‘‘prescription’’ is not (§ 40.327(a)(1)), for those positions that these things that are not controlled specifically defined in the CSA. require medical qualification, such as substances under the CSA. In addition, As noted earlier in the ‘‘Modification airline pilots, Coast Guard mariners and some state laws allowing marijuana use to the Drug Testing Panel’’ section, Commercial Driver’s License (CDL) the term ‘‘prescription,’’ even though a commenters to the proposal to add the drivers. For those without medical recommendation for someone to use four semi-synthetic opioids raised a certification requirements, these marijuana under state law is not a number of issues concerning MRO commenters believed that the MRO prescription consistent with the practice. One issue of concern to several would report a ‘‘safety concern’’ under Controlled Substances Act. commenters was whether a prescription § 40.327(a)(2) when, in the MRO’s The NPRM also proposed to allow should still be considered by the MRO medical judgment, the employee’s MROs to conduct additional testing (i.e., as a legitimate medical explanation if it continued performance of his or her for D,L stereoisomers of amphetamine had been filled a long time before the safety-sensitive function is likely to and methamphetamine isomers and/or positive test result (e.g., six months, a pose a significant safety risk. These tetrahydrocannabivarin (THC–V)) of a year, two years before the drug test that commenters’ concern was that, absent specimen, if doing so is necessary to an MRO is being asked to verify). They further regulatory language or guidance verify a test result. The testing for D,L said this is an important inquiry from DOT, some MROs might report stereoisomers of amphetamine and because the semi-synthetic opioids information to employers (e.g., methamphetamine can be useful to an proposed to be added to the DOT testing information about a semi-synthetic MRO in distinguishing whether a panel are Schedule II drugs that are opioid that an employee was legally methamphetamine positive resulted frequently prescribed and may be taking) from which an employer could from use of a legitimate over-the counter retained and used by the donor long infer an employee’s medical condition. product. An MRO can order a test for after the prescription was filled. Some These commenters believed that release THC–V to be conducted to determine commenters were concerned that MROs’ of information would not only whether the laboratory reported decisions have been and will continue compromise the employee’s medical marijuana result was due to the smoking to be inconsistent regarding the age of privacy but could threaten the of marijuana. The THC–V differential a prescription considered to be grounds employee’s job. One commenter thought testing can distinguish whether a THC for declaring a legitimate medical that paragraph (a)(2) should be deleted positive is due to the smoking of explanation for a positive result. altogether. Commenters suggested that, marijuana, a CSA Schedule I illegal A related comment asked that DOT before reporting a safety concern under drug, or is due to the use of Marinol, a clarify that an MRO could not question § 40.327(a)(1), an MRO should be CSA Schedule III prescribed a prescribing physician’s decision to required to contact the employee’s pharmaceutical. Because of this issue a prescription. That is, an MRO prescribing physician to determine regulatory change, MROs do not need to should not ‘‘second guess’’ the whether the physician was aware of the obtain DOT consent to order such tests. prescribing physician’s determination employee’s safety-sensitive duties and, However, MROs can use only that it was medically appropriate to if so, whether the prescribing physician laboratories that meet NLCP criteria for prescribe one of the four semi-synthetic believed the prescribed drug would not conducting these additional tests. opioids and verify a test as positive impair the employee’s ability to perform notwithstanding the existence of the those duties safely. Comments prescription. There were only nine comments on Other commenters recommended that DOT Response these specific proposals. All of them MROs should receive more frequent The Department is adopting the supported the authorization of MROs to training than currently required (e.g., NPRM’s proposal to authorize MROs to order the laboratory to test for D,L requalification training every three years conduct testing for D,L stereoisomers of stereoisomers of amphetamine and rather than every five years), with amphetamine and methamphetamine methamphetamine or THC–V. One special emphasis on issues concerning and THC–V. Most commenters agreed comment, from a testing industry the semi-synthetic opioids added to the that these proposals had merit. We do association, suggested that the DOT panel. One of these comments not believe it necessary to make the Department issue more detailed suggested that MROs should not be testing for D,L stereoisomers of guidance to MROs concerning when it authorized to make determinations amphetamine and methamphetamine is appropriate to order these tests. about these drugs until they had mandatory in methamphetamine cases,
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believing it better to leave this decision legally used by the person to whom it not have prescribed the medication to to MROs’ discretion. Neither is it was prescribed. Consequently, it would the donor. However, it is important to necessary to make THC–V testing not be appropriate for the Department to note that a valid concern about whether mandatory. To make these requirements substitute its judgment for that of the the employee can continue performance would be unnecessary in most cases and DEA, which is the Federal agency with safely may be present and the would, therefore, cause needless the authority for determining what prescribing physician may still be asked expense with no additional safety constitutes a valid prescription under to reconsider the employee’s use of the benefit. In response to those who the CSA. prescription in accordance with thought additional guidance is The MROs are highly qualified § 40.135(e). necessary, we will provide it in the individuals who Part 40 requires to MROs with a concern about a future on the basis of demonstrated make judgment calls. MROs must take physician’s prescribing practices can need. into account differences in medications, address this with the prescribing We will also adopt, with a slight and other case-specific factors. While physician or raise the issue with the change, the NPRM’s language saying some commenters characterize this as appropriate state licensing agency for that a prescription means a legally valid ‘‘inconsistent’’ across the breadth of a the prescribing physician. For example, prescription within the overall meaning national program, it carries out the an MRO can choose to file a complaint of the CSA. While, as one commenter intention that MROs will make with a local DEA office, a medical pointed out, the CSA does not contain individualized determinations for each licensing board, or other oversight an explicit definition of ‘‘prescription,’’ donor. Although it might be less work organization regarding the practices of a the Drug Enforcement Administration and superficially ‘‘consistent’’ for MROs prescribing physician who the MRO (DEA), which is designated by statute to to make decisions on the basis of a believes is violating standards of care. carry out the CSA, has regulations and ‘‘bright line’’ standard, doing so would That approach remains a more direct guidance regarding prescriptions. not advance the objectives of the way to address the possible malfeasance Therefore, we are changing the program. Consequently, the Department of the prescribing physician, instead of proposed language to say that a will not create a time limit on the use denying the legitimacy of the safety- prescription must be ‘‘consistent with’’ of a legally valid prescription. sensitive employee’s prescription. and not simply ‘‘under’’ the CSA. The Some commenters also suggested that The issue of states or nations (i.e., proposed language was already present the final rule prohibit an MRO from Canada and Mexico) that allow in § 40.135(e), so we will make a questioning whether the prescribing recommendations or state-recognized technical amendment to that language physician should have prescribed the ‘‘prescriptions’’ for ‘‘medical marijuana’’ for consistency. In addition, we have substance. That is, the MRO should not presents a completely different added the same language to § 40.137(a) be allowed to say, in effect, ‘‘yes, the consideration. Marijuana is a Schedule to provide clarity to MROs when employee has a legally valid I drug and, therefore, regardless of the verifying laboratory-confirmed positive prescription issued by his or her prescribing physician’s intent, it cannot test results. physician, but I think that the physician be the basis of a legitimate medical The key point of the phrase we have should not have issued that prescription explanation. Consistent with added is to make sure that a in the first place, or the prescription was longstanding DOT regulatory language prescription is legally valid. For for too high a dosage of a drug, so I and guidance (e.g., §§ 40.137(e)(2), example, regardless of any state won’t treat the prescription as a 40.151(e), and DOT ‘‘Medical ‘‘medical marijuana’’ laws, there cannot legitimate medical explanation for a Marijuana’’ Notice https://www. be a legally valid prescription for laboratory positive.’’ This situation transportation.gov/odapc/medical- marijuana, since it remains a Schedule could arise, for example, with respect to marijuana-notice; DOT ‘‘Recreational I substance under the CSA. prescriptions for the opioids added to Marijuana’’ Notice https://www. The issues concerning restricting an the DOT panel by this rule (or for any transportation.gov/odapc/dot- MRO’s judgment about how long a other legally prescribed drug identified recreational-marijuana-notice), MROs prescription may be considered to be in our drug panel), if an MRO thought must not treat medical marijuana legitimate are complex and not an employee’s doctor had been too authorizations under state law as appropriate for this rulemaking. The liberal in prescribing pain medications. providing a legitimate medical Department is concerned that We agree that it is inappropriate for explanation for a DOT drug test that is establishing a ‘‘bright line’’ cutoff date an MRO to question an employee’s positive for marijuana. for the valid use of a prescription—i.e., legally valid prescription in this way. We agree with commenters that MROs that an otherwise legally valid Even if the employee’s physician’s should receive appropriate information prescription would be regarded as no prescription practices are inconsistent concerning issues that may arise with longer providing a legitimate medical with an MRO’s understanding of good respect to the semi-synthetic opioids explanation for a laboratory positive standards of medical practice, added to the DOT panel in this final after a certain amount of time had employees are entitled to rely on their rule. The Department will issue passed—would be a too-facile substitute physicians’ prescriptions as guidance, as needed, highlighting for the individualized inquiry that we authorization to use the legally opioid issues that may arise. expect an MRO to make in such cases. prescribed substance as a legitimate We believe that shortening the MRO It could also result in an unintended medical explanation. To say otherwise re-training interval to three years would hardship on an employee who is not would place an unfair burden on the impose a cost and burden that is intentionally abusing a prescription employee to judge the appropriateness unnecessary. Since we already have medication but who unintentionally of his or her physician’s conduct. As a opiates in the DOT-regulated drug runs afoul of a standardized expectation logical outgrowth of this issue raised by testing panels, adding semi-synthetic for how quickly he or she will use commenters, we have added language to opioids to the panel is not a radical medication prescribed. § 40.137 of the final rule to prohibit change for these highly trained Medical The DEA has not set a maximum MROs from denying a legitimate Doctors and Doctors of Osteopathy. duration for the length of time a medical explanation because the MRO Likewise, requiring special training prescription can be considered to be thinks the prescribing physician should concerning opioids for MROs, or
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limiting their ability to verify opioid requirement). Second, the MRO must after the reporting the verified negative positive test results unless they had report the information to third parties if result to have the prescribing physician received such training, is likely to the ‘‘information indicates that contact the MRO to determine if the unnecessarily delay implementation of continued performance by the employee medication(s) can be changed to one the addition of these controlled of his or her safety-sensitive function is that does not make the employee substances to the program without a likely to pose a significant safety risk.’’ medically unqualified or that does not justifiable reason to require the training. The third parties to whom this pose a significant safety risk before There was no showing by commenters information can be disclosed are: The reporting the safety concern. If the MRO that, absent such specialized training employer; a DOT agency; a SAP; or an does not receive such information from outside the normal training process, examiner who determines whether the the prescribing physician, the MRO MROs would be incapable of assessing employee is medically qualified under would then report to third parties as whether there were legitimate medical an applicable DOT agency safety provided in § 40.327. The provision of explanations for opioid positive results. regulation. giving the employee five days to have Thus, we believe that additional We understand, and the commenters his/her prescribing physician contact training is not needed to ensure that were concerned, that MROs already the MRO is not new. In fact, it has been MROs are familiar with semi-synthetic apply the procedures of §§ 40.135 and in part 40 since the year 2000. The only opioid issues. 40.327 to commonly prescribed difference is that previously, the MRO As noted above, commenters were medications that can cause a laboratory- would first report the medical concerned that, as applied to commonly confirmed positive result. Thus, adding information and then wait for the prescribed substances like the semi- the semi-synthetic opioids would pose a prescribing physician to respond. We synthetic opioids covered by this rule, similar, but certainly not a new, have no reason to believe this process is § 40.327(a)(2) could lead to adverse scenario of a laboratory-confirmed not effective. However, in response to outcomes for employees such as positive that would be downgraded to a the commenters’ concerns, we are compromising the employee’s medical negative result because of a legally valid changing this process to provide the privacy or employment. For example, an prescription, and this medical employee the opportunity to allay any MRO might note that an employee had information would be reported to a third MRO safety risk concerns by having his a legally valid prescription for an party, when appropriate. or her prescribing physician change the opioid, which provided a legitimate This concern, however, should not be medication immediately, discuss other explanation for a laboratory positive overstated. There is not an automatic ways to eliminate or mitigate the MRO’s result, but then decide that the requirement for an MRO to report concerns, or both change the medication employer should be told that the medical information to third parties for and discuss alternatives. This should employee’s use of that opioid poses a every downgraded drug test result. also reduce the number of reports MROs There are and will continue to be cases significant safety risk, endangering the would make. We do not anticipate this where the MRO would not need to employee’s continued employment. change will increase costs because there report medical information to a third Given the apparent frequency with is no new collection of information, we party. We leave the determination of the which opioids are prescribed, are simply directing the MRO to pause significant safety risk to the ‘‘reasonable commenters feared that the occurrence for five days before reporting the medical judgment’’ of the MRO, of issues of this kind could increase. medical information to third parties. In Although we did not propose any new recognizing that every downgraded test fact, this pause may reduce costs language to § 40.327, we believe this result is not the same and needs the because we anticipate that it should section warrants a discussion and a individualized professional judgment of reduce the number of reports to slight amendment to the existing the MRO. language of § 40.135 as a logical The MROs have a serious safety duty employers under § 40.135(e). outgrowth of the commenter’s concerns when verifying the prescription an Although we are creating a pause as to the frequency with which medical employee provides to the MRO. Under before the MRO reports the information information would be reported because § 40.141(b), the MRO (and not the so that the employee can have time to of adding the four semi-synthetic MRO’s staff) must ‘‘review and take all communicate with the employee’s own opioids. It may not be necessary for the reasonable and necessary steps to verify physician, the part 40 requirement for MRO to report medical information to the authenticity of all medical records the MRO to report the downgraded test third parties in every case where the the employee provides.’’ With the result as a verified negative immediately MRO receives substantiated evidence advancement of photography remains unchanged. With this final rule, that an employee has a valid manipulation and enhancement the employer will receive a negative prescription that merits downgrading a software easily available through the result first and medical information, if result from a positive to a negative. Internet, MROs should speak with the necessary, will come later. Under § 40.327, an MRO must report pharmacy and not simply rely on a There may be cases where the MRO drug test results and medical photograph of the prescription label. is contacted by the employee’s information the MRO learns as part of That contact with the pharmacy can also physician before the end of the five the verification process to third parties shed light on whether there is a days, but the communication between without the employee’s consent if the significant safety risk posed in the the doctors does not alleviate the MRO determines, in his or her particular situation the MRO is significant safety risk that the MRO has reasonable medical judgement, that assessing. identified. In such cases, the MRO can either of two concerns is triggered. First, To ensure that the employee is not report the medical information to third the MRO is required to disclose to third caught by surprise by an MRO’s parties after the discussion with the parties information when the decision to report the medical employee’s physician; the MRO is not information obtained during the information regarding a legally valid required to allow five days to elapse. verification interview is likely to render prescription to a third party, we have Comments that MRO decisions should the employee medically unqualified amended § 40.135(e). Specifically, we be legally reviewed and that MROs and under an applicable DOT agency will direct the MRO to first provide the collectors should be subject to drug regulation (e.g., a fitness for duty employee with up to five business days testing are outside the scope of this
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rulemaking. Thus, they will not be evaluation and, what may have been a process, an MRO with advice from a addressed. refusal would result in a cancelled test. referral physician determines whether Two other commenters, also referred to there was a refusal to test or not. This E. Fatal Flaws and Questionable this same situation, saying that the approach of discarding the insufficient Specimens solution would be to clarify that this specimen is simple and direct, and The NPRM fatal flaw exists only when a specimen should reduce opportunities for The NPRM proposed to add three fatal was actually collected. confusion. It is also a cost-relieving With respect to the ‘‘questionable flaws to the existing list of four flaws provision. specimen’’ scenario on what to do with that would cause a test to be cancelled. a first specimen that was collected and V. Section-by-Section Analysis Each fatal flaw is an error that cannot be was out of temperature range or showed This portion of the preamble subsequently corrected because of the signs of tampering, but then a sufficient discusses each of the provisions of Part potential for each of the flaw to affect second specimen was not collected 40 amended by this final rule, including the accuracy and integrity of that under direct observation, we received responses to comments on matters that specimen. The existing fatal flaws are ten comments. All of these comments have not previously been discussed listed in §§ 40.83 and 40.199. The on the proposal supported it. under ‘‘Main Policy Issues.’’ proposed additional flaws were listed in a September 2016 revision of the HHS DOT Response A. Sections Concerning the Addition of NLCP Manual. Specifically, the flaws Three commenters who were Four Opioids to the DOT Drug Testing proposed to be added were: (1) There is concerned about a fatal flaw cancelling Panel no CCF; (2) two separate collections a test in the ‘‘insufficient specimen’’ In the ‘‘Main Policy Issues’’ portion of were performed using one CCF; and (3) scenario raised a good point related not the preamble, we discussed the proposal there was no specimen submitted to the only those scenarios, but also for to add four semi-synthetic opioids to the laboratory with the CCF. collection site walk-away refusals. The DOT drug testing panel and responded The NPRM also addressed a situation Department will adopt these to comments on that proposal. As noted when there is an initial ‘‘questionable’’ commenters’ suggestions that a fatal there, the Department is adopting this specimen (e.g., one calling for an flaw will exist in cases where a CCF is proposal. The primary section in which immediate recollection under direct sent to the laboratory without a the Department’s decision to add these observation because the temperature specimen, as long as there a specimen substances is carried out is § 40.87, was out of range or there were signs of was actually collected. This will avoid which lists each substance that is part tampering), but there was no second a situation in which, for example, there of the DOT panel, including the specimen provided (e.g., because the was a CCF filled out for an original additions made by this final rule, donor was unable to provide the second specimen, a shy bladder situation together with the initial test and specimen under direct observation, even occurred, no second specimen was confirmatory test cutoffs. There are after waiting three hours and drinking collected, but the CCF was mistakenly parallel changes in § 40.85(d) and fluids). The current regulation does not sent to the laboratory. The ultimate Appendices B and C, in each case provide clear instructions to the result of this process—a determination changing the term ‘‘opiates’’ to collector regarding what to do with the by the MRO about whether there was a ‘‘opioids.’’ A commenter suggested initial specimen in this scenario. The sufficient medical explanation for the rewording the proposed language in NPRM proposed that the collector employee’s failure to provide a full § 40.87, footnote 3, to match the discard the initial specimen in this case, specimen—could be confused by a language in the HHS Mandatory leaving the MRO to determine whether laboratory decision that there was a fatal Guidelines. After discussing this point there was a sufficient medical flaw, even though the fatal flaw has no with HHS, we changed the wording explanation for the ‘‘shy bladder.’’ impact upon the MRO’s determination from what was proposed to a more of a refusal. Accordingly, we have Comments accurate and plain language version, amended §§ 40.83 and 40.199, both of with no intended change in meaning. In One commenter noted that the which deal with this particular fatal §§ 40.137 and 40.139, a slightly different changes to fatal flaws by the NLCP, the flaw. term, ‘‘semi-synthetic opioids,’’ is used source of the Department’s proposed Otherwise, the Department is in the contexts of differing standards for changes, had not earlier been the subject adopting its proposal with respect to MRO verification of ‘‘natural’’ opioid of public comment before HHS changed fatal flaws without change. Commenters laboratory positives (e.g., codeine) and the HHS Mandatory Guidelines in this had the opportunity to comment on the newly added semi-synthetic opioids respect. This commenter also noted that these proposed changes in context of the to the DOT drug testing panel (e.g., there could be inconsistencies between DOT NPRM, whether or not HHS hydrocodone). HHS and DOT criteria for fatal flaws. provided such an opportunity Another commenter raised a technical concerning its changes to the HHS B. Definitions point with respect to the proposed Mandatory Guidelines. The final rule, like the NPRM, § 40.83(c)(2), requesting clarification to Regarding the ‘‘questionable clarifies the definition of ‘‘The say that a CCF without an specimen’’ scenario, the DOT is Department, DOT Agency’’ and accompanying specimen would become adopting the proposed amendment to ‘‘Drugs.’’ The main change in the latter a fatal flaw only when an actual Part 40 without change. All commenters is to use the broader term ‘‘opioids’’ in specimen had been collected. The agreed that, when a second specimen in place of ‘‘opiates,’’ to encompass the commenter explained that, in a shy a situation calling for a recollection substances that the rule adds to the DOT bladder or collection site refusal under direct observation cannot be drug panel. There were few comments situation, a collector might mistakenly obtained for ‘‘shy bladder’’ reasons, it on the proposed changes to this section. send a CCF to the laboratory, even when made sense to discard the first One commenter requested that we there was no specimen to send. If the questionable specimen and rely on the clarify that NASA or its contractors test were cancelled by the laboratory, insufficient specimen process for a were not DOT agencies. As readers of then there would be no shy bladder result. In the insufficient specimen the existing and new versions of this
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section will note, NASA is not listed as presently allowed under Part 40 for The affected provisions are in §§ 40.03, a DOT agency. As a Federal agency, DOT drug testing. There were four 40.29, 40.37, 40.103, 40.105, 40.123, NASA is subject to the Federal comments on this proposal, all of which 40.169, and 40.189. employee program that uses the HHS agreed with it. The Department is aware that a E. Prohibition on DNA Testing of Urine Mandatory Guidelines. Contractors to or Specimens employees of NASA or other Federal rulemaking that would authorize oral agencies who are subject to DOT fluid testing under the HHS Mandatory The NPRM proposed adding a regulations in their own right (e.g., Guidelines is currently in progress at sentence to paragraph (f) of this section because they perform safety-sensitive HHS. If HHS authorizes this method of further emphasizing the existing DOT functions as pilots, drivers or mariners testing, DOT could follow on with its prohibition on the use of DNA testing who would be covered by the respective own rulemaking to conform Part 40 to on DOT drug testing specimens applicable DOT agency regulations) the revision of the HHS Mandatory (§ 40.13(e)). The five commenters who would be covered by applicable DOT Guidelines, as long as the HHS final rule spoke to the proposal supported it. rules. is in accordance with OTETA’s other Several comments supported the We also included a technical requirements. Department’s long-standing grounds for amendment to this section based on a Likewise, it is our understanding that its position (e.g., that the CCF process recent official interpretation. HHS is considering whether to provides sufficient evidence of the Specifically, we are clarifying that the authorize hair testing as part of the HHS identity of a specimen; that DNA testing USCG is only a DOT agency for the drug Mandatory Guidelines. As in the case of would show only that an original testing component of Part 40 since its oral fluids, and given the Department’s specimen and a reference specimen that regulation (46 CFR part 16) incorporates statutory obligation to remain consistent the donor provided behind closed doors Part 40 for drug testing and not for with the HHS Mandatory Guidelines were different, not that a donor’s alcohol testing. and with OTETA’s other obligations, if specimen was misidentified). Some HHS authorizes the use of hair testing commenters added that the prohibition C. Three Provisions Related to Urine in a manner consistent with OTETA would preclude further intrusions into Specimens requirements, then the Department an employee’s privacy and potential Fatal Flaws would follow suit in its own rulemaking discrimination by employers against to amend Part 40. drivers whose DNA test revealed a The rationale for the Department’s We are also aware that there are potential medical condition. The new decision to add new items to the list of unusual circumstances in which testing language states that DNA testing is not ‘‘fatal flaws’’ and our response to other than urine testing can take place. authorized and ODAPC will not give comments on the proposal to do so, are For example, Federal Railroad permission for such testing. The found in the ‘‘Main Policy Issues’’ Administration (FRA) post-accident Department is adopting the proposed portion of this preamble. The affected testing, under the authority of 49 CFR language without change. provisions are §§ 40.83(c) (concerning part 219 (not Part 40), can involve blood fatal flaws detected by a laboratory as it testing and the testing of other body F. Legal Prescriptions and Additional processes a specimen) and 40.199 fluids and tissues. Likewise, the USCG, Testing (concerning the MRO’s responsibility to under the authority of 46 CFR part 4, As discussed under the MRO Practice cancel tests in which fatal flaws have may require other bodily fluids or Issues heading in the Main Policy Issues been found). tissues be chemically tested to portion of this preamble, the determine the presence or drugs or Department proposed to add a reference Shy Bladder Process—‘‘Questionable alcohol for post-accident events. Part 40 to legal prescriptions under the CSA to Specimens’’ recognizes certain situations when a this section, as well as to authorize As discussed under the Fatal Flaws clinical evaluation performed under the MROs to obtain THC–V testing and and Questionable Specimens heading in direction of the MRO is appropriate, and testing for D,L stereoisomers of the Main Policy Issues portion of this in those events the MRO may choose to amphetamine and methamphetamine at preamble, after considering the use another testing methodology (49 their discretion. After considering the comments on the subject, the CFR 40.195(a)(3)). The MRO may use comments, almost all of which were Department will require the collector to another testing methodology in these supportive, as discussed above, the discard any initial collection that was narrow situations for the purpose of Department has adopted this proposal questionable (e.g., out of temperature being able to clarify that a donor is not with the slight modification of range, showing signs of tampering). The using drugs, but not to show a positive ‘‘consistent with’’ instead of ‘‘under,’’ MRO would then evaluate a ‘‘shy test result. However, these situations are and incorporated these changes in bladder’’ situation that developed if the not inconsistent with the new § 40.210, §§ 40.137(b) and 40.135(e) for employee was unable to provide a which states that for drug tests required consistency. sufficient specimen for the direct by Part 40, only urine testing is G. Minor Modification to Certain observation recollection. This provision authorized. has been incorporated into Section Headings § 40.193(b)(4). D. Removing the Blind Specimen The NPRM proposed to modify the Testing Requirement section heading of §§ 40.137 and 40.139 Only Urine Specimens Are Authorized The rationale for the Department’s to incorporate the addition of the four for Testing decision to remove the blind specimen new semi-synthetic opioids. There were The NPRM proposed to add a new testing requirement, and our response to 10 comments on this proposal, all of section, § 40.210, clarifying, that Part 40 comments on the proposal to do so, are which agreed with it. The Department is authorizes drug testing of only urine found in the ‘‘Main Policy Issues’’ adopting the proposed language without specimens screened and confirmed at portion of this preamble. As a result of change. Also, as commenters correctly HHS-certified laboratories. This means this decision, sections, or references in pointed out, and as is discussed under that point-of-collection instant tests, sections, pertaining to the former blind the MRO Practice Issues heading in the hair tests, and oral fluid tests are not testing requirement have been removed. ‘‘Main Policy Issues’’ portion of this
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preamble, the proposed § 40.139(c)(3) has taken action under the Public training then-existing collectors in should be rephrased. This paragraph Interest Exclusion provisions to issue 2001–2003. Similar training deadlines, should provide that, in a situation Notices of Corrective Actions. all of which were established as part of where there is a laboratory positive for The Department does not approve, the transition to the 1999 revision of morphine or codeine (in the absence of certify, or endorse service agents or their Part 40 from previous editions, were a finding of 6–AM) below 15,000 ng/mL, activities. We regard the use of such found in §§ 40.121 (MROs), 40.213 and the employee admits to symbols or other means as implying (BATs/STTs), and 40.281 (SAPs). In unauthorized use of one of the semi- approval, certification or endorsement. addition, §§ 40.45 and 40.203 contained synthetic opioids, the MRO does not When a service agent makes such a a 2011 date to complete a transition to verify the test as positive. The final rule representation, the Department views it a revised custody and control form. makes this correction. as false and deceptive holding-out by a There were four comments on these party not part of the Federal changes, all of which supported them. H. Subscribing to the ODAPC List-Serve Government. For this reason, the NPRM These proposed changes are adopted in The rationale for the Department’s proposed to specifically add such false the final rule. In § 40.121(d), we also decision to require key persons in the representations to the grounds on which eliminated, as a commenter suggested, a DOT testing process to subscribe to the the Department could initiate a PIE reference to continuing education units ODAPC, and our response to comments proceeding against the offender. tied to one of the obsolete compliance on the proposal do so, are found in the Five of the six comments on this dates. ‘‘Main Policy Issues’’ portion of this subject supported this proposal and its preamble. The Department is adopting rationale. The sixth disagreed, on the L. Editorial Corrections the proposed language without change. basis that DOT did not articulate a In drafting the NPRM, we noted a few The affected provisions are §§ 40.33 safety basis for the proposal and that it sections in which editorial corrections (collectors), 40.121 (MROs), 40.213 could impose an unnecessary burden on would be helpful for purposes of (BATs/STTs), and 40.281 (SAPs). companies using agency ‘‘brands’’ to clarification. In § 40.67(n), we changed distinguish tests. ‘‘collector’’ to ‘‘service agent’’ to clarify I. Listing SAP Certification The basis for the proposal is to that all service agents had a Organizations on ODAPC’s Web Site prevent false and deceptive responsibility to ensure that a directly The NPRM proposed moving representations by organizations observed collection was conducted organizations who provide SAP marketing to DOT employers. Such when necessary. In § 40.162(c) a credentialing listed in § 40.281(a)(6) out misrepresentations are at least reference to § 40.159(f) was corrected to of Part 40 and onto the ODAPC Web misleading and at worst deliberately cite paragraph (g) of that section. In site. We proposed this change to deceptive. When a private party § 40.233(b)(4), a reference to provide greater flexibility for changes to misrepresents that it is part of or that it § 40.333(a)(2) was corrected to cite the list and quicker updates. There were is certified, approved or endorsed by the paragraph (a)(3) of that section. There four comments to the proposal, all of DOT or a DOT agency, this can have were three comments on these which supported it. The final rule safety implications for an employer that proposals, all of which agreed with the adopts the proposal without change. relies on the holding out of an proposed changes. These changes are One commenter asked for clarification endorsement if the service agent does adopted in the final rule. regarding whether there is a ‘‘grace’’ not provide services in accordance with period when an organization is removed DOT requirements. The Department and M. Updating Specified Appendices to from the list and what the timeline the DOT Agencies are not ‘‘brands,’’ and Part 40 would be for a SAP to be ‘re-qualified’ their names should not be used as if The NPRM proposed to update the under one of the approved they were. following appendices: Appendices B organizations. When a certifying One of the commenters who and C, to add the four semi-synthetic organization is added or removed from supported the proposal noted that opioids to the drugs listed and remove the list, the Department intends to training materials should be able to MDEA; Appendix D, to update a web notify the list-serve subscribers of the include materials that may contain link; and Appendix H, to remove the change. Since all SAPs will be required screen shots or references to DOT Web instruction sheet for the Management to subscribe to the list-serve, each SAP sites, and publications that contain DOT Information System Data Collection would receive this important logos, titles, etc. We agree. We from our regulations and move it to our notification. However, specific details appreciate that employers and service guidance material located on our Web regarding ‘‘grace periods for agents reproduce our publications and site. The reason for proposing to move requalification’’ would depend upon the other materials containing the DOT the MIS instruction sheet to the ODAPC facts of each situation and would, logos and this regulatory change would Web site was to provide greater therefore, be guidance that ODAPC not prohibit members of the public from flexibility for changes and/or updates to would provide at the relevant times. using and/or reproducing the materials this document. There were seven that are produced by ODAPC and/or the comments to the proposal to update the J. Prohibition From Using the DOT or DOT Agencies. The non-deceptive use appendices, all of which supported it. DOT Agency Name, Logos, or Other of such training materials is not The final rule adopts this proposal Official Branding something that we would view as without change. The Department is concerned that violating our rules because it does not N. Updating Web Links some service agents misrepresented indicate approval or certification by the themselves as approved, certified, or Department or a DOT agency. The Department proposed to update endorsed by the Department, by means web links in the rule text that have including, but not limited to, the use of K. Removing Obsolete Compliance Dates changed on our DOT Web site. There a DOT or DOT agency logo, title, or The NPRM proposed removing were four comments to this proposal, all emblem. Where we have found these obsolete compliance dates from several of which supported the proposal. In misuses of DOT or DOT agency names, sections. For example, former § 40.33(d) several sections, the Department logos, or other official branding, ODAPC established compliance dates for updated the ODAPC Web address to the
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current http://www.transaportation.gov/ VI. Other Comments Environmental Policy Act of 1969 odapc. The affected sections are There were two comments concerning (NEPA) (42 U.S.C. 4321 et seq.) requires §§ 40.33, 40.45, 40.105, 40.121, 40.205, the cost-benefit analysis. Those DOT to analyze this action to determine 40.213, 40.225, 40.281, and 40.401. In comments are addressed in the whether it will have an effect on the addition, in Appendix D, the regulatory analysis section titled quality of the environment. This portion Department updated the Web link for Executive Order 12866 and 13563 and of the preamble summarizes the DOT’s reporting split specimens failing to DOT’s Regulatory Policies and analyses of these impacts with respect reconfirm to https:// Procedures. to this rule. www.transportation.gov/content/split- There were a number of comments Executive Order 12866 and 13563 and specimen-cancellation-notification-49- that were outside the scope of the cfr-part-40187-appendix-d. These DOT’s Regulatory Policies and NPRM, such as including (or not Procedures updates are adopted in the final rule. including) hair or oral fluid testing in This final rule is not a significant O. Alcohol Testing Device Web Links the DOT program, reducing the subject regulatory action under Executive Order matter of refresher training for BATs/ Though not among the originally 12866 and 13563, as well as the STTs, including additional drugs (e.g., proposed changes, we are making a Department’s Regulatory Policies and benzodiasepines) in the drug testing technical amendment to make it easier Procedures (44 FR 11034). It proposes to panel, providing more oversight of MRO to permit employers to use alcohol harmonize specific Part 40 procedures decisions, changing some criteria for testing devices approved by the with recently mandated HHS Guidelines testing in the Federal Transit National Highway Traffic Safety and, in the interest of improving Administration rules (49 CFR part 655), Administration (NHTSA), which are the efficiency, make certain program broadening the use of electronic only devices permitted to be used for modifications. As such, this proposal signatures in the program, allowing DOT alcohol testing. Since 1994, the would not impose any major policy laboratories to use their own protocols regulation has required employers and changes and would not impose any for substituted specimen situations, service agents to only us a device once significant new costs or burdens. the device was approved by NHTSA and reporting from laboratories to MROs appeared on NHTSA’s conforming through a third party, and criteria for Costs determining when a test is considered to products lists (CPLs) for alcohol The NPRM screening devices (ASDs) and Evidential have been refused. While these and Breath Testing Devices (EBTs). NHTSA other matters may be worth As noted in the Department’s NPRM, used the CPLs to add approved devices consideration at a later time, they are the HHS Mandatory Guidelines and remove devices as appropriate. outside the scope of the present addressed the burdens associated with Because there was no regular schedule rulemaking. the addition of new drugs to the drug- testing panel (82 FR 7920, January 23, with which the CPLs were published, VII. Regulatory Analyses and Notices employers and alcohol technicians were 2017). The cost impact of drug testing prohibited by the regulation from using Changes to Federal regulations are for oxycodone, oxymorphone, newly approved devices because a new subject to a number of regulatory hydrocodone, and hydromorphone CPL was not published. To permit requirements, which are identified and would be minimal because HHS employers and alcohol technician the discussed below. First, Executive Orders determined that all HHS-certified ability to use a device as soon possible 12866 and 13563 direct that each laboratories testing specimens from after NHTSA approves it, we will now Federal agency shall propose or adopt a Federal agencies are currently list the NHTSA-approved ASDs on a regulation only upon a reasoned conducting tests for one or more of these new ODAPC Web page entitled determination that the benefits of the analytes on non-regulated urine ‘‘Approved Screening Devices to intended regulation justify its costs. specimens. HHS further indicated in its Measure Alcohol in Bodily Fluids’’ and Second, the Regulatory Flexibility Act analysis that laboratory personnel we will now list the NHTSA approved of 1980 (Pub. L. 96–354), as codified in currently are trained to test for the EBTs on new ODAPC Web page for 5 U.S.C. 601 et seq., requires agencies to additional drugs and test methods ‘‘Approved Evidential Breath analyze the economic impact of already have been implemented. Many Measurement Devices.’’ Although, we regulatory changes on small entities. HHS-certified laboratories conduct non- will no longer require regulated parties The Paperwork Reduction Act of 1995 regulated tests for transportation to check the actual CPL, we will (PRA) (44 U.S.C. 3501 et seq.) requires employers who already include the four continue to rely on NHTSA for approval that DOT consider the impact of semi-synthetic opioids in their non- and removal of the devices. ODAPC will paperwork and other information regulated testing programs. For those take responsibility for creating and collection burdens imposed on the employers, therefore, shifting the four continuing to keep the Web pages public and, under the provisions of PRA drugs from non-regulated tests to updated whenever NHTSA notifies us section 3507(d), obtain approval from regulated tests would not increase that a device has been approved and OMB for each collection of information testing costs. added to the list, or removed from the it conducts, sponsors, or requires HHS determined that the costs list. This is purely an administrative through regulations. Section (a)(5) of associated with implementation of change as to where to find the list of division H of the Fiscal Year 2005 testing for the four additional semi- approved devices. There are no costs Omnibus Appropriations Act, Public synthetic opioids would be associated with this technical change Law 108–447, 118 Stat. 3268 (Dec. 8, approximately $0.11–$0.30 per test. and it should be burden-reducing 2004) and section 208 of the E- Once the testing has been implemented, because it will avoid confusion that has Government Act of 2002, Public Law the cost per specimen for initial testing been occurring for DOT-regulated 107–347, 116 Stat. 2889 (Dec. 17, 2002) for the added analytes would range from parties and for the product requires DOT to conduct a Privacy $.06 to $0.20 due to reagent costs. manufacturers. Accordingly, we have Impact Assessment (PIA) of a regulation Current costs for each confirmatory test made changes to §§ 40.3; 40.229; 40.231; that will affect the privacy of range from $5.00 to $10.00 for each 40.233 and 40.235. individuals. Finally, the National specimen reported as positive due to
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costs of sample preparation and Federal agency affected because cost is synthetic opioids instead of just the analysis. HHS indicated that based on usually based on all specimens additional 3% estimated by HHS. As we information from non-regulated submitted from an agency, rather than understand it, the upper limit cost of a workplace drug testing for these individual specimen testing costs or MRO review for non-negatives is analytes in 2012 and testing performed MRO review of positive specimens. approximately $60. Given the estimated on de-identified federally regulated Based on this analysis, therefore, DOT 1% (63,000) of specimens confirming specimens in 2011, approximately 1% projects an additional MRO cost of for the semi-synthetic opioids, the of the submitted specimens is expected $189,000 (.03 projected increase × estimated additional costs for MRO to be confirmed as positive for the 6,300,000 DOT tests annually). reviews resulting from this final rule added analytes. Therefore, HHS would be $3,780,000 ($60 × 63,000). Comments indicates that the added cost for Regarding the specific comment for confirmatory testing will be $0.05 to There were two comments on our cost DOT to consider the confirmation test $0.10 per submitted specimen. estimates. One questioned the projected costs for the four prescription drug Approximately 6.3 million DOT- cost savings of the proposal to eliminate initial positive tests, not just the regulated tests occur per year. DOT the blind specimen testing requirement. projected 1% of the specimens that are considered the maximum ranges HHS Specifically, the commenter said that confirmed positive, the Department has provided in its analysis. Therefore, with the cost savings were inflated because no basis to conclude that there will be the projected maximum implementation we did not take into consideration the an additional cost to DOT-regulated cost per specimen of $0.30, the 50-blind specimen limit per quarter and employers for specimens that screen maximum cost per specimen of initial that blinds are not required to be positive but do not confirm as positive. testing at $0.20, and the maximum cost submitted for employers with fewer Furthermore, the commenters did not per specimen of confirmation testing at than 2,000 employees. The same provide any data to support their $0.10, the additional cost per urine test commenter also questioned why DOT assertion. As we understand it and as would be an additional $0.60. Under the did not factor in increased potential explained in our ‘‘What Employers new HHS Mandatory Guidelines, and costs that were mentioned by Need to Know About DOT Drug and based on an estimated 6.3 million DOT commenters in the HHS rulemaking Alcohol Testing’’ handbook, employers tests conducted annually, a cost of such as, increased estimated MRO costs may choose one of two pricing approximately $3,800,000 would be of 10% and start-up costs to laboratories structures, bundled and unbundled. realized by employers subject to DOT- to implement testing for the additional Bundled pricing means that one-price- regulated testing ($0.60 × 6,300,000 analytes. Another commenter requested fits-all. The price of the bundle is DOT tests annually = $3,780,000). that we further explain the analysis for dependent on various factors like HHS indicated that there will be the costs associated with confirmation volume and positive rate. In unbundled minimal costs associated with adding testing. Specifically, the commenter pricing, it is ‘a la carte’ pricing for each MDA as an initial test analyte because wanted us to adjust the cost-benefit test the laboratory has to run. Our the current immunoassays can be analysis to address confirmation test projected costs assume a bundled adapted to test for this analyte. costs for the four prescription drug pricing structure since it appears to be According to HHS, before a lab is initial positive tests, not just the widely used. allowed to test regulated specimens for projected 1% of the specimens that are We also want to address two issues MDA, HHS must test three groups of confirmed positive. The commenter related to information we provided in performance test, or ‘‘PT’’ samples. HHS suggested that, when making this our NPRM. First, we incorrectly provides the PT samples at no cost to its calculation, DOT consider using associated the full cost of the certified laboratories but HHS estimates laboratory data for the percentage of Proficiency Testing (PT) to only the cost that the laboratory costs to conduct the positive test results that will require a of testing for MDA. However, based on PT testing would range from $900 to confirmation test. HHS final rule [82 FR 7931], the cost for $1,800 for each certified laboratory. PT testing ($48,600) is for all the semi- DOT Response There are approximately 27 HHS- synthetic opioids and MDA, not just certified laboratories who process DOT Regarding the blind specimen costs, MDA. Accordingly, our cost analysis drug tests. With the maximum cost our response is included in the ‘cost- now correctly articulates that the cost of estimate of $1,800 for each certified savings’ paragraph of this section. As for PT is for all the compounds as outlined laboratory, a cost of approximately the comment about not factoring in in HHS’ final rule. This does not change $48,600 would be realized for DOT potential costs that were mentioned by the quantified cost of the rule. Second, ($1,800 × 27 laboratories = $48,600.) commenters in the HHS rulemaking, we we estimated that the per specimen cost Testing for additional drugs would did not see the need to address them would be an additional $0.60 result in new MRO costs, as MROs since HHS already responded to those (implementation cost of $0.30 and a would have additional review and comments (82 FR 7931). In short, HHS maximum screening and confirmation verification to conduct. Based on the assumed the start-up costs for testing testing cost of $0.30) for a total cost of positivity rates from non-regulated the four semi-synthetic opioids, and $3,780,000 ($0.60 × 6,300,000). As we workplace drug testing and the changes to the amphetamines would be mentioned earlier, HHS assumed the additional review of specimens with a de minimis given that laboratories could start-up costs would be de minimis. laboratory confirmed positive for use existing immunoassays. DOT agrees that the start-up costs are prescription medications, HHS To further explain the costs associated expected to be de minimis. Therefore, estimates that MRO costs would with verifying test results for the we have removed the implementation increase by approximately 3%. The additional semi-synthetic opioids, we costs (approximately an additional additional costs for testing and MRO agree with the commenters that the 3% $0.30 per specimen) that were originally review would be incorporated into the estimated by HHS may not be sufficient proposed. Thus, a cost of $1,890,000 overall cost for the Federal agency for calculating the costs to the DOT- ($0.30 × 6,300,000) would be realized by submitting the specimen to the regulated industries. We have added the employers subject to DOT-regulated laboratory. HHS bases the estimation of full cost of the MRO review of the non- testing and not the $3,780,000 we costs incurred on overall cost to the negative results for the four semi- originally estimated.
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On a final note, we acknowledge blind testing conducted annually at a it would adversely affect any sector of potential costs that were not discussed cost of approximately $50 per test yields the economy. in the NPRM for those employees with a cost-savings of $3,150,000 (63,000 × Regulatory Flexibility Analysis positive test results that would $50). The Regulatory Flexibility Act of 1980 potentially go through the return-to- Comments duty process. As we mentioned earlier, (Pub. L. 96–354, ‘‘RFA’’), 5 U.S.C. 601 we estimated that 1% (63,000) of the One commenter suggested that the et seq., establishes ‘‘as a principle of specimens will be confirmed for one or savings from the elimination of blind regulatory issuance that agencies shall more of the semi-synthetic opioids. specimen testing had been endeavor, consistent with the objectives Based on MRO’s experiences in non- overestimated, because the cost-benefit of the rule and of applicable statutes, to DOT testing that 80% of the semi- analysis did not take into account the fit regulatory and informational synthetic results will be downgraded to 50-specimen maximum and the requirements to the scale of the ‘negative’ due to legitimate medical requirement that only employers with businesses, organizations, and explanations (e.g., valid prescriptions), more than 2,000 covered employees governmental jurisdictions subject to we estimate that only 12,600 of the were required to submit blind regulation. To achieve this principle, 63,000 laboratory confirmed positives specimens. agencies are required to solicit and consider flexible regulatory proposals will be reported by the MRO as verified DOT Response positive. We further estimate that, of the and to explain the rationale for their We revised our calculation to take 12,600 verified positive results, actions to assure that such proposals are into consideration the commenter’s approximately 25% (3,150) will given serious consideration.’’ The RFA concerns. Our revised calculation takes covers a wide-range of small entities, participate in the return-to-duty process. into account: The estimated number of The other individuals will not return to including small businesses, not-for- DOT-regulated employers (728,324) and profit organizations, and small positions that require DOT testing or employees (5,192,065); the known will continue working at their non-DOT governmental jurisdictions. number of employers (175) with Agencies must perform a review to positions. With the mandatory employee counts from 2,000 to 50,000; determine whether a proposed rule Substance Abuse Professional (SAP) an estimated number of C/TPAs (2,158) would have a significant economic evaluation costing approximately $400, with an employee count of 2,000; the impact on a substantial number of small the return-to-duty test costing 25% random testing rate and estimated entities. If the agency determines that it approximately $50, and the minimum of number of other tests; the 1% blind would, the agency must prepare a six follow-up tests costing specimen rate; and an estimated cost of regulatory flexibility analysis. However, approximately $300 (6 × $50), the $50 per blind specimen test. The if an agency determines that it is not return-to-duty cost would be estimated number of C/TPAs is based on expected to have a significant economic approximately $750 per employee. the assumption that the smaller impact on a substantial number of small Altogether, the Department estimates employers (employers with less than entities, section 605(b) provides that the the total return-to-duty costs to be 2,000 employees), would join a C/TPA head of the agency may so certify, and approximately $2,362,500 (3,150 × to administer their random testing pools a regulatory flexibility analysis would $750). and other aspects of the DOT program This estimate does not include costs not be required. The certification must and include them in their consortium. associated with education or treatment include a statement providing the Accordingly, we project annual cost- that the employee completes before factual basis for this determination, and savings from eliminating the blinds taking the required return-to-duty test. the reasoning should be clear. would be $1,298,016. We have placed in This final rule conforms the existing A verified positive result merely the docket for this rulemaking a DOT drug-testing panel to recently identifies that the individual needs to document describing the basis for this issued HHS Mandatory Guidelines and, seek treatment. The positive result does estimate and calculation in greater with certain minor amendments (mostly not create the employee’s condition. By detail. editorial), to improve the efficiency of seeking treatment sooner than later, the the DOT drug-testing program. The net potential costs associated with Net Economic Impact costs of this rule do not constitute a education and treatment for an The DOT believes the projected cost significant burden to any entity, small individual that tests positive could be to the DOT of implementing testing for or otherwise. Consequently, the DOT less than if the employee did not test the additional drugs being added to the certifies, under the RFA, that this rule positive. drug-testing regimen will be minimal. will not have a significant economic Cost-Savings The projected $1,938,600 for the four impact on a substantial number of small semi-synthetic opioid drugs and PT entities. The NPRM testing ($1,890,000 and $48,600 In the NPRM, DOT estimated a cost- respectively) and the $3,780,000 Federalism savings of at least $3.1 million per year projected MRO costs would result in This rule has been analyzed in from the elimination of the requirement total projected costs of $5,718,600. The accordance with the principles and for employers to submit blind specimen projected cost savings from eliminating criteria contained in Executive Order testing to laboratories (estimated at the blind specimen testing requirement 13132 (‘‘Federalism’’). This rule does approximately $50 per test). This would be $1,298,016. The estimated net not include requirements that (1) have estimate of cost-savings is based on the cost impact of this proposal, therefore, substantial direct effects on the States, regulatory analysis performed when would be $4,420,584 ($5,718,600 ¥ the relationship between the national DOT reduced blind specimen testing in $1,298,016) per year. This rule will not government and the States, or the 2000 (65 FR 79462, 79517, Dec. 19, have an economically significant impact distribution of power and 2000), adjusted for inflation. Based on under Executive Order 12866 because it responsibilities among the various the blind specimen requirements made would not have an annual effect on the levels of government, (2) impose effective in 2000 for employers to economy of $100 million or more, nor substantial direct compliance costs on submit 1% of 6,300,000 DOT tests for do we have any basis to conclude that State and local governments, or (3)
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preempt State law. Therefore, the Executive Order 13771: Reducing because it conforms to the model consultation and funding requirements Regulation and Controlling Regulatory specifications from NHTSA. of Executive Order 13132 do not apply. Costs * * * * * Paperwork Reduction Act/Privacy Act Executive Order 13771 titled DOT, The Department, DOT Agency. ‘‘Reducing Regulation and Controlling These terms encompass all DOT The Paperwork Reduction Act Regulatory Costs,’’ directs that, unless agencies, including, but not limited to, requires that the DOT consider the prohibited by law, whenever an the Federal Aviation Administration impact of paperwork and other executive department or agency (FAA), the Federal Railroad information collection burdens imposed publicly proposes for notice and Administration (FRA), the Federal on the public. Information collections comment or otherwise promulgates a Motor Carrier Safety Administration for Part 40 currently are approved under new regulation, it shall identify at least (FMCSA), the Federal Transit OMB Control No. 2105–0529. The two existing regulations to be repealed. Administration (FTA), the National Privacy Act provides safeguards against In addition, any new incremental costs Highway Traffic Safety Administration invasion of personal privacy through the associated with new regulations shall, to (NHTSA), the Pipeline and Hazardous the extent permitted by law, be offset by misuse of records by Federal Agencies. Materials Safety Administration the elimination of existing costs. This It establishes controls over what (PHMSA), and the Office of the rule is not an Executive Order 13771 personal information is collected, Secretary (OST). For purposes of this regulatory action because this rule is not maintained, used and disseminated by part, the United States Coast Guard significant under Executive Order (USCG), in the Department of Homeland agencies in the executive branch of the 12866. Federal government. Security, is considered to be a DOT This rule does not create any new List of Subjects in 49 CFR Part 40 agency for drug testing purposes only since the USCG regulation does not paperwork or other information Administrative practice and incorporate Part 40 for its alcohol collection burdens needing approval, procedures, Alcohol abuse, Alcohol testing program. These terms include nor would it require any further testing, Drug abuse, Drug testing, any designee of a DOT agency. protections under the Privacy Act. Laboratories, Reporting and recordkeeping requirements, Safety, * * * * * National Environmental Policy Act Transportation. Drugs. The drugs for which tests are The Department has analyzed the The Final Rule required under this part and DOT agency regulations are marijuana, environmental impacts of this action For reasons discussed in the cocaine, amphetamines, phencyclidine pursuant to the National Environmental preamble, the Department of Policy Act of 1969 (NEPA) (42 U.S.C. Transportation is amending part 40 of (PCP), and opioids. 4321 et seq.) and has determined that it Title 49 Code of Federal Regulations, as * * * * * is categorically excluded pursuant to follows: Evidential Breath Testing Device DOT Order 5610.1C, Procedures for (EBT). A device that is approved by the Considering Environmental Impacts (44 PART 40—PROCEDURES FOR National Highway Traffic Safety FR 56420, Oct. 1, 1979). Categorical TRANSPORTATION WORKPLACE Administration (NHTSA) for the exclusions are actions identified in an DRUG AND ALCOHOL TESTING evidential testing of breath at the .02 agency’s NEPA implementing PROGRAMS and .04 alcohol concentrations, and procedures that do not normally have a ■ 1. The authority citation for 49 CFR appears on ODAPC’s Web page for significant impact on the environment part 40 is revised to read as follows: ‘‘Approved Evidential Breath and therefore do not require either an Measurement Devices’’ because it Authority: 49 U.S.C. 102, 301, 322, 5331, conforms with the model specifications environmental assessment (EA) or 20140, 31306, and 54101 et seq. environmental impact statement (EIS). available from NHTSA. ■ See 40 CFR 1508.4. In analyzing the 2. Amend § 40.3 as follows: ■ a. Revise the definition of ‘‘Alcohol * * * * * applicability of a categorical exclusion, screening device (ASD)’’; ■ 3. Revise § 40.26 to read as follows: Federal agencies also must consider ■ b. Remove the definition ‘‘Blind whether extraordinary circumstances specimen or blind performance test § 40.26 What form must an employer use are present that would warrant the specimen’’; to report Management Information System preparation of an EA or EIS. This rule ■ c. Revise and reorder (in correct data to a DOT agency? does not meet any of these criteria. The alphabetical order) the definition ‘‘DOT, As an employer, when you are Department does not anticipate any the Department, DOT Agency’’; required to report MIS data to a DOT environmental impacts, and there are no ■ d. Revise the definition ‘‘Drugs’’; and ■ agency, you must use the U.S. extraordinary circumstances present in e. Revise the definition of ‘‘Evidential Department of Transportation Drug and connection with this rulemaking. breath testing device (EBT)’’. Alcohol Testing MIS Data Collection The revisions read as follows: Unfunded Mandates Reform Act Form to report that data. You must use § 40.3 What do the terms used in this part the form at appendix H to this part. You The Unfunded Mandates Reform Act mean? may view and download the of 1995 (2 U.S.C. 1531–1538) does not * * * * * instructions on the Department’s Web require a written statement for this final Alcohol screening device (ASD). A site (https://www.transportation.gov/ rule because the rule does not include breath or saliva device, other than an odapc). You must submit the MIS report a Federal mandate that may result in the EBT, that is approved by the National in accordance with rule requirements expenditure in any one year of Highway Traffic Safety Administration (e.g., dates for submission, selection of $155,000,000 or more by State, local, (NHTSA) and appears on ODAPC’s Web companies required to submit, and and tribal governments, or the private page for ‘‘Approved Screening Devices method of reporting) established by the sector. to Measure Alcohol in Bodily Fluids’’ DOT agency regulating your operation.
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§ 40.29 [Amended] § 40.37 [Amended] (4) Two separate collections are ■ performed using one CCF; ■ 4. Amend § 40.29 by removing the 6. Amend § 40.37 by removing the entry ‘‘§ 40.103—Processing blind (5) The specimen ID numbers on the entry ‘‘§§ 40.103–40.105—Blind specimens.’’ specimen bottle and the CCF do not specimen requirements.’’ match; § 40.45 [Amended] ■ 5. Amend § 40.33 by revising (6) The specimen bottle seal is broken paragraphs (a) and (d) to read as follows: ■ 7. Amend § 40.45(a) by removing the or shows evidence of tampering, unless parenthetical ‘‘(http://www.dot.gov/ a split specimen can be redesignated § 40.33 What training requirements must a odapc)’’ and adding, in its place (see paragraph (h) of this section); collector meet? ‘‘(http://www.transportation.gov/ (7) There is an insufficient amount of * * * * * odapc)’’ and § 40.45(b) by removing the urine in the primary bottle for analysis, unless the specimens can be (a) Basic information. You must be parenthetical ‘‘(e.g., that after November 30, 2011, they must not use an expired redesignated (see paragraph (h) of this knowledgeable about this part, the CCF for DOT urine collections)’’ section). current ‘‘DOT Urine Specimen ■ Collection Procedures Guidelines,’’ and 8. Amend § 40.67 by revising * * * * * paragraph (n) to read as follows: DOT agency regulations applicable to ■ 10. Revise § 40.85 to read as follows: the employers for whom you perform § 40.67 When and how is a directly § 40.85 What drugs do laboratories test collections. DOT agency regulations, the observed collection conducted? for? DOT Urine Specimen Collection * * * * * As a laboratory, you must test for the Procedures Guidelines, and other (n) As a service agent, when you learn following five drugs or classes of drugs materials are available from ODAPC that a directly observed collection in a DOT drug test. You must not test should have been collected but was not, (Department of Transportation, 1200 ‘‘DOT specimens’’ for any other drugs. you must inform the employer that it New Jersey Avenue SE., Washington (a) Marijuana metabolites. must direct the employee to have an DC, 20590, 202–366–3784, or on the (b) Cocaine metabolites. immediate recollection under direct ODAPC Web site (https:// (c) Amphetamines. observation. www.transportation.gov/odapc). You (d) Opioids. ■ must keep current on any changes to 9. Amend § 40.83 by revising (e) Phencyclidine (PCP). paragraph (c) to read as follows: these materials. You must subscribe to ■ 11. Amend § 40.87 by revising the ODAPC list-serve at: https:// § 40.83 How do laboratories process paragraph (a) to read as follows: www.transportation.gov/odapc/get- incoming specimens? odapc-email-updates. § 40.87 What are the cutoff concentrations * * * * * for drug tests? * * * * * (c) You must inspect each specimen and CCF for the following ‘‘fatal flaws:’’ (a) As a laboratory, you must use the (d) You must meet the requirements (1) There is no CCF; cutoff concentrations displayed in the of paragraphs (b) and (c) of this section (2) In cases where a specimen has following table for initial and before you begin to perform collector been collected, there is no specimen confirmatory drug tests. All cutoff functions. submitted with the CCF; concentrations are expressed in * * * * * (3) There is no printed collector’s nanograms per milliliter (ng/mL). The name and no collector’s signature; table follows:
Confirmatory Initial test analyte Initial test cutoff 1 Confirmatory test analyte test cutoff con- centration
Marijuana metabolites (THCA) 2 ...... 50 ng/mL3 ...... THCA ...... 15 ng/mL. Cocaine metabolite (Benzoylecgonine) ... 150 ng/mL 3 ...... Benzoylecgonine ...... 100 ng/mL. Codeine/ ...... 2000 ng/mL ...... Codeine ...... 2000 ng/mL. Morphine Morphine ...... 2000 ng/mL. Hydrocodone/ ...... 300 ng/mL ...... Hydrocodone ...... 100 ng/mL. Hydromorphone Hydromorphone ...... 100 ng/mL. Oxycodone/ ...... 100 ng/mL ...... Oxycodone ...... 100 ng/mL. Oxymorphone Oxymorphone ...... 100 ng/mL. 6-Acetylmorphine ...... 10 ng/mL ...... 6-Acetylmorphine ...... 10 ng/mL. Phencyclidine ...... 25 ng/mL ...... Phencyclidine ...... 25 ng/mL. Amphetamine/ ...... 500 ng/mL ...... Amphetamine ...... 250 ng/mL. Methamphetamine Methamphetamine ...... 250 ng/mL. MDMA 4/MDA 5 ...... 500 ng/mL ...... MDMA ...... 250 ng/mL. MDA ...... 250 ng/mL. 1 For grouped analytes (i.e., two or more analytes that are in the same drug class and have the same initial test cutoff): Immunoassay: The test must be calibrated with one analyte from the group identified as the target analyte. The cross-reactivity of the immunoassay to the other analyte(s) within the group must be 80 percent or greater; if not, separate immunoassays must be used for the analytes within the group. Alternate technology: Either one analyte or all analytes from the group must be used for calibration, depending on the technology. At least one analyte within the group must have a concentration equal to or greater than the initial test cutoff or, alternatively, the sum of the analytes present (i.e., equal to or greater than the laboratory’s validated limit of quantification) must be equal to or greater than the initial test cutoff. 2 An immunoassay must be calibrated with the target analyte, D-9-tetrahydrocannabinol-9-carboxylic acid (THCA). 3 Alternate technology (THCA and Benzoylecgonine): When using an alternate technology initial test for the specific target analytes of THCA and Benzoylecgonine, the laboratory must use the same cutoff for the initial and confirmatory tests (i.e., 15 ng/mL for THCA and 100ng/mL for Benzoylecgonine). 4 Methylenedioxymethamphetamine (MDMA). 5 Methylenedioxyamphetamine (MDA).
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* * * * * using pursuant to a legally valid (3) To be the basis of a verified prescription consistent with the positive result for codeine or morphine, § 40.103 [Removed] Controlled Substances Act, you will the clinical evidence you find must ■ 12. Remove § 40.103. allow 5 business days from the date you concern a drug that the laboratory found report the verified negative result for the in the specimen. (For example, if the § 40.105 [Removed] employee to have the prescribing test confirmed the presence of codeine, ■ 13. Remove § 40.105. physician contact you to determine if and the employee admits to ■ 14. Amend § 40.121 by revising the medication can be changed to one unauthorized use of hydrocodone, you paragraphs (b)(3) and (c)(3), and the that does not make the employee must not verify the test positive for paragraph (d) introductory text to read medically unqualified or does not pose codeine. The admission must be for the as follows: a significant safety risk. If, in your substance that was found through the reasonable medical judgment, a medical actual drug test.) § 40.121 Who is qualified to act as an qualification issue or a significant safety * * * * * MRO? risk remains after you communicate ■ 19. Amend § 40.141 by revising * * * * * with the employee’s prescribing paragraph (b) to read as follows: (b) * * * physician or after 5 business days, (3) You must be knowledgeable about whichever is shorter, you must follow § 40.141 How does the MRO obtain this part, the DOT MRO Guidelines, and § 40.327. If, as the MRO, you receive information for the verification decision? the DOT agency regulations applicable information that eliminates the medical * * * * * to the employers for whom you evaluate qualification issue or significant safety (b) If the employee asserts that the drug test results, and you must keep risk, you must transmit this information presence of a drug or drug metabolite in current on any changes to these to any third party to whom you his or her specimen results from taking materials. You must subscribe to the previously provided information under prescription medication (i.e., a legally ODAPC list-serve at https:// § 40.327. valid prescription consistent with the www.transportation.gov/odapc/get- ■ 17. Amend § 40.137 by revising the Controlled Substances Act), you must odapc-email-updates. DOT agency section heading and paragraph (a) to review and take all reasonable and regulations, DOT MRO Guidelines, and read as follows: necessary steps to verify the other materials are available from authenticity of all medical records the ODAPC (Department of Transportation, § 40.137 On what basis does the MRO verify test results involving marijuana, employee provides. You may contact 1200 New Jersey Avenue SE, the employee’s physician or other Washington, DC 20590, 202–366–3784), cocaine, amphetamines, semi-synthetic opioids, or PCP? relevant medical personnel for further or on the ODAPC Web site (http:// information. You may request an HHS- www.transportation.gov/odapc). (a) As the MRO, you must verify a confirmed positive test result for certified laboratory with validated (c) * * * protocols (see § 40.81(c)) to conduct (3) You must meet the requirements of marijuana, cocaine, amphetamines, testing for D,L stereoisomers of paragraphs (a), (b), and (c) of this semi-synthetic opioids (i.e., amphetamine and methamphetamine or section before you begin to perform hydrocodone, hydromorphone, testing for tetrahydrocannabivarin MRO functions. oxycodone, and oxymorphone), and/or (THC- V) when verifying lab results, as (d) Requalification training. During PCP unless the employee presents a you determine necessary. each five-year period from the date on legitimate medical explanation for the ■ which you satisfactorily completed the presence of the drug(s)/metabolite(s) in 20. Amend § 40.162 by revising examination under paragraph (c)(2) of his or her system. In determining paragraph (c) to read as follows: this section, you must complete whether an employee’s legally valid § 40.162 What must MROs do with multiple requalification training. prescription consistent with the verified results for the same testing event? Controlled Substances Act for a * * * * * * * * * * substance in these categories constitutes ■ 15. Amend § 40.123 by revising (c) As an exception to paragraphs (a) a legitimate medical explanation, you paragraph (e) to read as follows: and (b) of this section, as the MRO, you must not question whether the must follow procedures at § 40.159(g) § 40.123 What are the MRO’s prescribing physician should have when any verified non-negative result is responsibilities in the DOT drug testing prescribed the substance. also invalid. program? * * * * * * * * * * ■ 18. Amend § 40.139 by revising the § 40.169 [Amended] (e) You must act to investigate and section heading and paragraphs (c) ■ 21. Amend § 40.169 by removing the correct problems where possible and introductory text and (c)(3) to read as entry ‘‘§ 40.105—Notification of notify appropriate parties (e.g., HHS, follows: discrepancies in blind specimen DOT, employers, service agents) where results.’’ assistance is needed, (e.g., cancelled or § 40.139 On what basis does the MRO problematic tests, incorrect results). verify test results involving 6- § 40.189 [Amended] acetylmorphine, codeine, and morphine? * * * * * ■ 22. Amend § 40.189 by removing the * * * * * ■ entry ‘‘§ 40.103—Blind split 16. Amend § 40.135 by revising (c) For all other codeine and specimens.’’ paragraph (e) to read as follows: morphine positive results, you must ■ verify a confirmed positive test result 23. Amend § 40.193 by revising § 40.135 What does the MRO tell the paragraph (b)(4) to read as follows: employee at the beginning of the only if you determine that there is verification interview? clinical evidence, in addition to the § 40.193 What happens when an employee * * * * * urine test, of unauthorized use of any does not provide a sufficient amount of (e) You must also advise the employee opium, opiate, or opium derivative (i.e., urine for a drug test? that, before informing any third party morphine, codeine, or heroin). * * * * * about any medication the employee is * * * * * (b) * * *
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(4) If the employee has not provided § 40.210 Are drug tests other than urine ■ 30. Amend § 40.231 by revising a sufficient specimen within three hours permitted under the regulations? paragraph (a) to read as follows: of the first unsuccessful attempt to No. Drug tests other than on urine provide the specimen, you must specimens are not authorized for testing § 40.231 What devices are used to conduct alcohol confirmation tests? discontinue the collection, note the fact under this part. Only urine specimens on the ‘‘Remarks’’ line of the CCF (Step screened and confirmed at HHS (a) EBTs on ODAPC’s Web page for 2), and immediately notify the DER. You certified laboratories (see § 40.81) are ‘‘Approved Evidential Breath must also discard any specimen the allowed for drug testing under this part. Measurement Devices’’ that meet the employee previously provided to Point-of-collection urine testing or requirements of paragraph (b) of this include any specimen that is ‘‘out of instant tests are not authorized. section are the only devices you may temperature range’’ or shows signs of ■ 27. Amend § 40.213 by revising use to conduct alcohol confirmation tampering. In the remarks section of the paragraphs (a), (d), and (e) to read as tests under this part. CCF that you will distribute to the MRO follows: * * * * * and DER, note the fact that the ■ § 40.213 What training requirements must 31. Amend § 40.233 by revising employee provided an ‘‘out of STTs and BATs meet? paragraphs (a) introductory text and temperature range specimen’’ or (c)(4) to read as follows: ‘‘specimen that shows signs of * * * * * (a) You must be knowledgeable about tampering’’ and that it was discarded § 40.233 What are the requirements for the alcohol testing procedures in this because the employee did not provide a proper use and care of EBTs? part and the current DOT guidance. second sufficient specimen. (a) As an EBT manufacturer, you must Procedures and guidance are available * * * * * submit, for NHTSA approval, a quality from ODAPC (Department of assurance plan (QAP) for your EBT ■ 24. Amend § 40.199 by revising Transportation, 1200 New Jersey before ODAPC places the EBT on its paragraph (b) to read as follows: Avenue SE., Washington, DC 20590, Web page for ‘‘Approved Evidential 202–366–3784, or on the ODAPC Web Breath Measurement Devices.’’ § 40.199 What problems always cause a site, http://www.transportation.gov/ * * * * * drug test to be cancelled? odapc). You must keep current on any (c) * * * * * * * * changes to these materials. You must (4) You must maintain records of the (b) The following are ‘‘fatal flaws’’: subscribe to the ODAPC list-serve at inspection, maintenance, and (1) There is no CCF; (https://www.transportation.gov/odapc/ get-odapc-email-updates). calibration of EBTs as provided in (2) In cases where a specimen has § 40.333(a)(3). been collected, there is no specimen * * * * * * * * * * submitted with the CCF; (d) You must meet the requirements ■ 32. Amend § 40.235 by revising (3) There is no printed collector’s of paragraphs (b) and (c) of this section paragraph (a) to read as follows: name and no collector’s signature; before you begin to perform STT or BAT functions. (4) Two separate collections are § 40.235 What are the requirements for (e) Refresher training. No less performed using one CCF; proper use and care of ASDs? frequently than every five years from the (5) The specimen ID numbers on the date on which you satisfactorily (a) As an ASD manufacturer, you specimen bottle and the CCF do not complete the requirements of must submit, for NHTSA approval, a match; paragraphs (b) and (c) of this section, QAP for your ASD before NHTSA (6) The specimen bottle seal is broken you must complete refresher training approves it and ODAPC places the or shows evidence of tampering (and a that meets all the requirements of device on its Web page for ‘‘Approved split specimen cannot be re-designated, paragraphs (b) and (c) of this section. Screening Devices to Measure Alcohol in Bodily Fluids’’. Your QAP must see § 40.83(h)); or * * * * * (7) Because of leakage or other causes, specify the methods used for quality there is an insufficient amount of urine § 40.225 [Amended] control checks, temperatures at which the ASD must be stored and used, the in the primary specimen bottle for ■ 28. Amend § 40.225(a) by removing shelf life of the device, and analysis and the specimens cannot be the parenthetical ‘‘(http://www.dot.gov/ environmental conditions (e.g., re-designated (see § 40.83(h)). dapc)’’ and adding, in its place ‘‘(http:// temperature, altitude, humidity) that * * * * * www.transportation.gov/odapc)’’ may affect the ASD’s performance. ■ ■ 29. Revise § 40.229 to read as follows: 25. Amend § 40.203 by revising * * * * * paragraph (d)(3) to read as follows: § 40.229 What devices are used to conduct ■ 33. Amend § 40.281 by revising alcohol screening tests? § 40.203 What problems cause a drug test paragraphs (a)(6), (b)(3), and (c)(3) to to be cancelled unless they are corrected? ASDs listed on ODAPC’s Web page for read as follows: * * * * * ‘‘Approved Screening Devices to Measure Alcohol in Bodily Fluids’’ and § 40.281 Who is qualified to act as a SAP? (d) * * * EBTs listed on ODAPC’s Web page for * * * * * (3) The collector uses a non-Federal ‘‘Approved Evidential Breath (a) * * * form or an expired CCF for the test. This Measurement Devices’’ are the only (6) You are a drug and alcohol flaw may be corrected through the devices you are allowed to use to counselor certified by an organization procedure set forth in § 40.205(b)(2), conduct alcohol screening tests under listed at https:// provided that the collection testing this part. You may use an ASD for DOT www.transportation.gov/odapc/sap. process has been conducted in alcohol tests only if there are (b) * * * accordance with the procedures in this instructions for its use in this part. An (3) You must be knowledgeable about part in an HHS-certified laboratory. ASD can be used only for screening tests this part, the DOT agency regulations ■ 26. Add § 40.210 to subpart I to read for alcohol, and must not be used for applicable to the employers for whom as follows: confirmation tests. you evaluate employees, and the DOT
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SAP Guidelines. You must keep current Appendix B to Part 40—DOT Drug- (a) Fatal flaw (number) on any changes to these materials. You Testing Semi-Annual Laboratory (b) Uncorrected Flaw (number) must subscribe to the ODAPC list-serve Report to Employers 4. Positive Results Reported (total number) at https://www.transportation.gov/ By Drug The following items are required on each (a) Marijuana Metabolite (number) odapc/get-odapc-email-updates. DOT laboratory report: (b) Cocaine Metabolite (number) agency regulations, DOT SAP Reporting Period: (inclusive dates) (c) Opioids (number) Guidelines, and other materials are Laboratory Identification: (name and address) (1) Codeine (number) available from ODAPC (Department of Employer Identification: (name; may include (2) Morphine (number) Transportation, 1200 New Jersey Billing Code or ID code) (3) 6–AM (number) Avenue SE., Washington DC, 20590 C/TPA Identification: (where applicable; (4) Hydrocodone (number) (202–366–3784), or on the ODAPC Web name and address) (5) Hydromorphone (number) site (http://www.transportation.gov/ 1. Specimen Results Reported (total number) (6) Oxycodone (number) (7) Oxymorphone (number) By Test Reason odapc). (d) Phencyclidine (number) (a) Pre-employment (number) (c) * * * (e) Amphetamines (number) (b) Post-Accident (number) (3) You must meet the requirements of (1) Amphetamine (number) (c) Random (number) paragraphs (a), (b), and (c) of this (2) Methamphetamine (number) (d) Reasonable Suspicion/Cause (number) section before you begin to perform SAP (3) MDMA (number) (e) Return-to-Duty (number) (4) MDA (number) functions. (f) Follow-up (number) 5. Adulterated Results Reported (total * * * * * (g) Type of Test Not Noted on CCF number) ■ 34. Amend § 40.331 by revising (number) By Reason (number) paragraph (f) to read as follows: 2. Specimens Reported 6. Substituted Results Reported (total (a) Negative (number) number) § 40.331 To what additional parties must (b) Negative and Dilute (number) 7. Invalid Results Reported (total number) employers and service agents release 3. Specimens Reported as Rejected for By Reason (number) information? Testing (total number) ■ * * * * * By Reason 39. Revise Appendix D to Part 40 to (f) Except as otherwise provided in (a) Fatal flaw (number) read as follows: this part, as a laboratory you must not (b) Uncorrected Flaw (number) 4. Specimens Reported as Positive (total Appendix D to Part 40—Report Format: release or provide a specimen or a part number) By Drug Split Specimen Failure To Reconfirm of a specimen to a requesting party, (a) Marijuana Metabolite (number) Mail, fax, or submit electronically to: without first obtaining written consent (b) Cocaine Metabolite (number) from ODAPC. DNA testing and other (c) Opioids (number) U.S. Department of Transportation, Office of types of identity testing are not (1) Codeine (number) Drug and Alcohol Policy and Compliance, (2) Morphine (number) W62–300, 1200 New Jersey Avenue SE., authorized and ODAPC will not give Washington, DC 20590, Fax: (202) 366– (3) 6–AM (number) permission for such testing. If a party 3897. Submit Electronically: https:// (4) Hydrocodone (number) seeks a court order directing you to www.transportation.gov/content/split- (5) Hydromorphone (number) specimen-cancellation-notification-49-cfr- release a specimen or part of a specimen (6) Oxycodone (number) part-40187-appendix-d contrary to any provision of this part, (7) Oxymorphone (number) The following items are required on each you must take necessary legal steps to (d) Phencyclidine (number) report: contest the issuance of the order (e.g., (e) Amphetamines (number) 1. MRO name, address, phone number, and seek to quash a subpoena, citing the (1) Amphetamine (number) fax number. (2) Methamphetamine (number) requirements of § 40.13). This part does 2. Collection site name, address, and phone (3) MDMA (number) not require you to disobey a court order, number. (4) MDA (number) however. 3. Date of collection. 5. Adulterated (number) 4. Specimen I.D. number. * * * * * 6. Substituted (number) 5. Laboratory accession number. ■ 35. Amend § 40.365 by revising 7. Invalid Result (number) paragraph (b)(10) to read as follows: 6. Primary specimen laboratory name, ■ 38. Revise Appendix C to Part 40 to address, and phone number. § 40.365 What is the Department’s policy read as follows: 7. Date result reported or certified by concerning starting a PIE proceeding? primary laboratory. Appendix C to Part 40—DOT Drug- 8. Split specimen laboratory name, * * * * * Testing Semi-Annual Laboratory address, and phone number. (b) * * * Report to DOT 9. Date split specimen result reported or (10) For any service agent, falsely certified by split specimen laboratory. representing that the service agent or its Mail, fax, or email to: 10. Primary specimen results (e.g., name of activities is approved or certified by the U.S. Department of Transportation, Office of drug, adulterant) in the primary specimen. Department or a DOT agency (such Drug and Alcohol Policy and Compliance, 11. Reason for split specimen failure-to- representation includes, but is not W62–300, 1200 New Jersey Avenue SE., reconfirm result (e.g., drug or adulterant not Washington, DC 20590, Fax: (202) 366– present, specimen invalid, split not collected, limited to, the use of a Department or 3897, Email: [email protected]. DOT agency logo, title, or emblem). insufficient volume). The following items are required on each 12. Actions taken by the MRO (e.g., * * * * * report: notified employer of failure to reconfirm and Reporting Period: (inclusive dates) § 40.401 [Amended] requirement for recollection). Laboratory Identification: (name and address) 13. Additional information explaining the ■ 36. Amend § 40.401(a) by removing 1. DOT Specimen Results Reported (total reason for cancellation. the parenthetical ‘‘(http://www.dot.gov/ number) 14. Name of individual submitting the ost/dapc)’’ and adding, in its place 2. Negative Results Reported (total number) report (if not the MRO) ‘‘(http://www.transportation.gov/ Negative (number) Negative-Dilute (number) ■ 40. Amend Appendix H to Part 40 by: odapc)’’ 3. Rejected for Testing Results Reported (total ■ a. Revising the introductory text; and ■ 37. Revise Appendix B to Part 40 to number) ■ b. Removing the instruction sheet read as follows: By Reason entitled: ‘‘U.S. DEPARTMENT OF
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TRANSPORTATION DRUG AND Resources of the Gulf (FMP). The FMP with the Magnuson-Stevens Act and ALCOHOL TESTING MIS DATA was prepared by the Gulf Fishery other applicable laws. COLLECTION FORM INSTRUCTION Management Council and is This action is taken under 50 CFR SHEET’’. implemented under the authority of the 622.41(b)(1) and is exempt from review Magnuson-Stevens Fishery The revision reads as follows: under Executive Order 12866. Conservation and Management Act Appendix H to Part 40—DOT Drug and (Magnuson-Stevens Act) by regulations These measures are exempt from the Alcohol Testing Management at 50 CFR part 622. All gray triggerfish procedures of the Regulatory Flexibility Information System (MIS) Data weights discussed in this temporary rule Act because the temporary rule is issued Collection Form are in round weight. without opportunity for prior notice and The following form is the MIS Data On August 4, 2008, NMFS established comment. Collection form required for use to report gray triggerfish accountability measures This action responds to the best calendar year MIS data. as well as commercial quotas for gray scientific information available. The triggerfish through Amendment 30A to * * * * * NOAA Assistant Administrator for the FMP (73 FR 38139). On May 9, 2013, Issued in Washington, DC on November 3, Fisheries (AA), finds that the need to 2017. NMFS issued a final rule to implement Amendment 37 to the FMP (78 FR immediately implement this action to Elaine L. Chao, 27084). In part, Amendment 37 revised close the commercial sector for gray Secretary of Transportation. gray triggerfish commercial annual triggerfish constitutes good cause to [FR Doc. 2017–24397 Filed 11–9–17; 8:45 am] catch limits (ACLs) and ACTS. waive the requirements to provide prior BILLING CODE 4910–9X–P Under 50 CFR 622.41(b)(1), NMFS is notice and opportunity for public required to close the commercial sector comment pursuant to the authority set for gray triggerfish when the commercial forth in 5 U.S.C. 553(b)(B), as such DEPARTMENT OF COMMERCE quota is reached, or is projected to be procedures are unnecessary and reached, by filing a notification to that contrary to the public interest. Such National Oceanic and Atmospheric effect with the Office of the Federal procedures are unnecessary because the Administration Register. NMFS has determined that the final rule implementing Amendment 37 commercial quota for Gulf gray (78 FR 27084; May 9, 2013), which 50 CFR Part 622 triggerfish of 60,900 lb (27,624 kg) will established the closure provision for [Docket No. 121004518–3398–01] be reached by November 18, 2017. commercial gray triggerfish, have Accordingly, the commercial sector for RIN 0648–XF815 already been subject to notice and Gulf gray triggerfish is closed effective comment, and all that remains is to 12:01 a.m., local time, November 18, Fisheries of the Caribbean, Gulf of notify the public of the closure. Such 2017, until the start of the next Mexico, and South Atlantic; 2017 procedures are contrary to the public commercial fishing season on January 1, Commercial Accountability Measure interest because of the need to 2018. and Closure for Gulf Gray Triggerfish The operator of a vessel with a valid immediately implement this action to protect gray triggerfish since the AGENCY: National Marine Fisheries commercial vessel permit for Gulf reef Service (NMFS), National Oceanic and fish having gray triggerfish onboard capacity of the fishing fleet allows for Atmospheric Administration (NOAA), must have landed and bartered, traded, rapid harvest of the commercial quota. Commerce. or sold such gray triggerfish prior to Prior notice and opportunity for public comment would require time and could ACTION: Temporary rule; closure. 12:01 a.m., local time, November 18, 2017. During the closure, the sale or potentially result in a harvest well in SUMMARY: NMFS implements purchase of gray triggerfish taken from excess of the established commercial accountability measures for commercial the Gulf EEZ is prohibited. The quota. gray triggerfish in the exclusive prohibition on the sale or purchase does For the aforementioned reasons, the economic zone (EEZ) of the Gulf of not apply to gray triggerfish that were AA also finds good cause to waive the Mexico (Gulf) through this temporary harvested, landed ashore, and sold prior 30-day delay in the effectiveness of this rule. NMFS projects commercial to 12:01 a.m., local time, November 18, action under 5 U.S.C. 553(d)(3). landings for gray triggerfish will reach 2017, and were held in cold storage by the commercial annual catch target a dealer or processor. Authority: 16 U.S.C. 1801 et seq. (ACT)(commercial quota) by November The recreational sector for gray Dated: November 7, 2017. triggerfish is also closed through 18, 2017. Therefore, NMFS is closing Emily H. Menashes, the commercial sector for gray December 31, 2017. Therefore all harvest or possession of gray triggerfish Acting Director, Office of Sustainable triggerfish in the Gulf EEZ on November Fisheries, National Marine Fisheries Service. 18, 2017. This closure is necessary to is prohibited until the start of the new [FR Doc. 2017–24519 Filed 11–9–17; 8:45 am] protect the gray triggerfish resource. fishing year (50 CFR 622.39(b)). The BILLING CODE 3510–22–P DATES: This rule is effective 12:01 a.m., commercial and recreational sectors for local time, November 18, 2017, until gray triggerfish will reopen on January January 1, 2018. 1, 2018, the beginning of the 2018 gray triggerfish fishing year. FOR FURTHER INFORMATION CONTACT: Kelli O’Donnell, NMFS Southeast Classification Regional Office, telephone: 727–824– The Regional Administrator, 5305, email: [email protected]. Southeast Region, NMFS, has SUPPLEMENTARY INFORMATION: The reef determined this temporary rule is fish fishery of the Gulf includes gray necessary for the conservation and triggerfish and is managed under the management of gray triggerfish and the Fishery Management Plan for Reef Fish Gulf reef fish fishery and is consistent
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DEPARTMENT OF COMMERCE DATES: Effective November 7, 2017, Regional Administrator must first through December 31, 2017. approve any such transfer based on the National Oceanic and Atmospheric FOR FURTHER INFORMATION CONTACT: criteria in § 648.162(e). Administration Cynthia Hanson, Fishery Management North Carolina is transferring 100,000 Specialist, (978) 281–9180. lb (45,359 kg) of Atlantic bluefish 50 CFR Part 648 commercial quota to Rhode Island. This SUPPLEMENTARY INFORMATION: transfer was requested by state officials [Docket No. 151130999–6594–02] Regulations governing the Atlantic in Rhode Island to ensure their 2017 bluefish fishery are found in 50 CFR commercial bluefish quota would not be 648.160 through 648.167. The RIN 0648–XF807 exceeded. Both states have agreed to the regulations require annual specification transfer and certified that it meets all Fisheries of the Northeastern United of a commercial quota that is pertinent state requirements. The States; Atlantic Bluefish Fishery; apportioned among the coastal states revised bluefish quotas for calendar year Quota Transfer from Maine through Florida. The 2017 are now: North Carolina, 2,638,704 process to set the annual commercial lb (1,196,896 kg); and Rhode Island, AGENCY: National Marine Fisheries quota and the percent allocated to each 681,563 lb (309,152 kg); based on the Service (NMFS), National Oceanic and state are described in § 648.162 and the initial quotas published in the 2016– Atmospheric Administration (NOAA), initial 2017 allocations were published 2018 Atlantic Bluefish Specifications Commerce. on March 13, 2017 (82 FR 13402). and subsequent transfers. ACTION: Temporary rule; quota transfer. The final rule implementing Amendment 1 to the Bluefish Fishery Classification SUMMARY: NMFS announces that the Management Plan published in the This action is taken under 50 CFR State of North Carolina is transferring a Federal Register on July 26, 2000 (65 FR part 648 and is exempt from review portion of its 2017 commercial bluefish 45844), and provided a mechanism for under Executive Order 12866. quota to the State of Rhode Island. This transferring bluefish quota from one Authority: 16 U.S.C. 1801 et seq. quota adjustment is necessary to comply state to another. Two or more states, with the Atlantic Bluefish Fishery under mutual agreement and with the Dated: November 7, 2017. Management Plan quota transfer concurrence of the NMFS Greater Emily H. Menashes, provisions. This announcement informs Atlantic Regional Administrator, can Acting Director, Office of Sustainable the public of the revised commercial request approval of a transfer of bluefish Fisheries, National Marine Fisheries Service. quotas for North Carolina and Rhode commercial quota under [FR Doc. 2017–24534 Filed 11–7–17; 4:15 pm] Island. § 648.162(e)(1)(i) through (iii). The BILLING CODE 3510–22–P
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Proposed Rules Federal Register Vol. 82, No. 217
Monday, November 13, 2017
This section of the FEDERAL REGISTER FOR FURTHER INFORMATION CONTACT: clarify that capacity funds are provided contains notices to the public of the proposed Maggie Ewell, Senior Policy Advisor, by formula to eligible institutions. issuance of rules and regulations. The 202–401–0222. The term and definition for qualifying purpose of these notices is to give interested educational activities was removed due SUPPLEMENTARY INFORMATION: persons an opportunity to participate in the to the fact that this term has caused rule making prior to the adoption of the final I. Background and Purpose rules. confusion regarding what constitutes an allowable qualifying educational The National Institute of Food and activity. NIFA follows the authorized Agriculture (NIFA) is revising part 3419 DEPARTMENT OF AGRICULTURE uses of funds in NARETPA, codified at of Title 7, subtitle B, chapter XXXIV of 7 U.S.C. 3221 and 3222, for extension National Institute of Food and the Code of Federal Regulations which and research programs. Research funds Agriculture implements the matching requirements are for conducting agricultural research, provided under section 1449 of the printing, disseminating the results of 7 CFR Part 3419 National Agricultural Research, research, administration, planning and Extension, and Teaching Policy Act of direction, purchase and rental of land, 1977 (NARETPA) for agricultural RIN 0524–AA68 and the construction, acquisition, research and extension capacity alteration, or repair of buildings Matching Funds Requirements for (formula) funds authorized for the 1890 necessary for conducting agricultural Agricultural Research and Extension land-grant institutions, including research. Extension funds are for the Capacity Funds at 1890 Land-Grant Central State University, Tuskegee expenses of conducting extension Institutions and 1862 Land-Grant University, and West Virginia State programs and activities. 7 U.S.C. 3221(e) Institutions in Insular Areas University and 1862 land-grant expressly prohibits extension funds institutions in insular areas. This from being spent on college course AGENCY: National Institute of Food and revision is required due to the statutory teaching or lectures in college. Agriculture amendments of sections 7212 of the NARETPA also contains definitions ACTION: Proposed rule and withdrawal Farm Security and Rural Investment Act that explain the difference between of proposed rule. of 2002 (FSRIA); section 7127 of the education in conjunction with extension Food, Conservation, and Energy Act of programs and education and teaching. SUMMARY: The National Institute of Food 2008; and section 7129 of the Extension education is defined as and Agriculture (NIFA) withdraws the Agricultural Act of 2014. Additionally, ‘‘informal’’ while teaching and Notice of Proposed Rulemaking (RIN NIFA is making changes to the education is defined as ‘‘formal 0524–AA25) published on April 29, Definitions and Use of Matching Funds classroom instruction,’’ which is 2003. In addition, NIFA proposes to sections to provide clarity on allowable expressly prohibited under 7 U.S.C. revise its regulations for the purpose of uses of matching funds. NIFA rescinds 3221(e). implementing the statutory amendments the previous, not yet finalized, Notice of Because the authorized uses related to applicable to the matching requirements Proposed Rulemaking published in the education expenses are clearly outlined for Federal agricultural research and Federal Register on April 29, 2003, RIN in NARETPA and in 7 U.S.C. 3221 and extension capacity (formula) funds for 0524–AA25 (68 FR 23013). 3222, NIFA does not see value in 1890 land-grant institutions (LGUs), § 3419.1 Definitions. The definition including the term ‘‘qualifying including Central State University, of eligible institution was updated to educational activity’’ as a term in Tuskegee University, and West Virginia include West Virginia State University regulation and, further, wants to ensure State University, and 1862 land-grant (formerly West Virginia State College) there is no conflict between its institutions in insular areas, and to and Central State University. Section regulatory authorizations and the law. remove the term ‘‘qualifying educational 753 of the Agricultural, Rural Therefore, NIFA is removing the term activities.’’ These matching Development, Food and Drug ‘‘qualifying educational activity’’ and requirements were amended by the Administration, and Related Agencies will allow only informal educational Farm Security and Rural Investment Appropriations Act, 2002 (Pub. L. 107– activities, as authorized by statute. Act; the Food, Conservation, and Energy 76) restored 1890 land-grant institution § 3419.2 Matching funds Act of 2008; and the Agricultural Act of status to West Virginia State College. In requirements. Revisions to this section 2014. 2004, the West Virginia Legislature were required due to statutory DATES: As of November 13, 2017, the approved West Virginia State College’s amendments of sections 7212 of FSRIA; proposed rule published April 29, 2003, transition to University status. Central section 7127 of the Food, Conservation, at 68 FR 23013, is withdrawn. Submit State University was recognized as an and Energy Act of 2008; and section comments on the proposed rule on or 1890 land-grant institution under 7129 of the Agricultural Act of 2014. before January 12, 2018. section 7129 of the Agricultural Act of The information regarding Fiscal Years ADDRESSES: You must submit 2014. 2000, 2001, and 2002 were removed as comments, identified by 7 CFR part In 2014, NIFA re-branded its formula they are outdated and no longer 3419, electronically through the Federal grant programs as ‘‘capacity grants.’’ applicable. NIFA proposes replacing eRulemaking Portal: http:// Therefore, the definition of formula this text with the matching www.regulations.gov. Follow the funds is changed to reflect this requirements for 1862 land-grant instructions online for submitting terminology, capacity funds, and the institutions in insular areas for the comments. words ‘‘by formula’’ were inserted to Smith-Lever 3(b) and (c) program (7
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U.S.C. 343(e)(4)(A)) and the Hatch Act application for funds or at any time 343 for Smith-Lever programs and 7 program (7 U.S.C. 361c(d)(4)(A)), which during the period of performance of the U.S.C. 361a for Hatch Act programs. state that insular areas will provide award. Additionally, NIFA includes a For 1890 Extension and Research matching funds from non-Federal requirement for current supporting programs, NIFA follows the sources in an amount equal to not less documentation, where current is authorizations included in NARETPA, than 50 percent of the formula funds defined as within the past two years codified at 7 U.S.C. 3221 and 3222. distributed by NIFA to each of the 1862 from the date of the letter requesting the Research funds are for conducting land-grant institutions in insular areas, waiver. It is critical that NIFA base its agricultural research; printing; respectively. NIFA proposes replacing decisions for matching waivers on the disseminating the results of research, existing text with the matching current state of affairs within the State administration, planning and direction; requirement to the Evans Allen/Section and institution. Using older data does purchase and rental of land; and the 1445 fund program (7 U.S.C. 3222d) and not provide adequate rationale for NIFA construction, acquisition, alteration, or Extension/Section 1444 fund programs to waive the statutorily required match repair of buildings necessary for (7 U.S.C. 3221) which state that the for capacity programs. conducting agricultural research. State will provide equal matching funds § 3419.5 Certification of matching Extension funds are for the expenses of from non-Federal sources. funds. The only proposed change in this conduction extension programs and § 3419.3 Limited Waiver Authority. section is changing the word ‘‘formula’’ activities. 7 U.S.C. 3221(e) expressly The section entitled, ‘‘Determination of to ‘‘capacity,’’ consistent with the prohibits extension funds from being non-Federal sources of funds,’’ § 3419.3, current terminology used by NIFA. spent on college course teaching or has been removed, because it reiterated § 3419.6 Use of matching funds. lectures in college. a statutory requirement to submit, in the NIFA proposes minor technical changes NARETPA also contains definitions year 1999, a report on non-Federal to this section, use of the term that explain the difference between funds used as match to be submitted. ‘‘capacity’’ in place of ‘‘formula’’ and education in conjunction with extension There is no further statutory ‘‘must’’ in place of ‘‘shall.’’ These programs versus education and requirement or authority to submit technical changes have no impact on the teaching. Extension education is defined reports on the sources of non-Federal requirements from the existing to the as ‘‘informal’’ while teaching and funds, therefore NIFA proposes the proposed regulation. Additionally, education is defined as ‘‘formal removal of this section. Section 3419.4 NIFA proposes to add clarifying classroom instruction,’’ which is Limited Waiver Authority will be re- language that matching funds must be expressly prohibited under 7 U.S.C. designated as § 3419.3 and modified to used for the same purpose as Federal 3221(e). include the provisions of 7 U.S.C. dollars as well as a specific prohibition Because the authorized uses related to 3222d(d): Authorization of a 50% on the use of tuition dollars and student education expenses are clearly outlined waiver of matching funds authority for fees as match. in NARETPA and 7 U.S.C. 3221 and 1890 land-grant institutions. The intent of the proposed rule is to 3222, NIFA does not see value in Additionally, § 3419.3 includes the clarify two requirements. First, the including the term ‘‘qualifying authority to waive up to 100% of the revised proposed rule clarifies that educational activity’’ as a term in required match for 1862 land-grant matching funds must be used by an regulation and further, wants to ensure institutions in insular areas that is eligible institution for the same purpose there is no conflict between its present in 7 U.S.C. 343(e)(4)(B). as Federal award dollars: Agricultural regulatory authorizations and the law. NIFA also proposes to add to this research and extension activities that Therefore, NIFA is removing the term section a description of the criteria a have been approved in the plan of work. ‘‘qualifying educational activity;’’ land-grant institution must demonstrate Second, the revised proposed rule however, the removal is intended to in order to be eligible for a waiver. The removes the end phrase: ‘‘or for prohibit expenditures related to formal three criteria are: Impacts from natural approved qualifying educational education activities. NIFA will allow disaster, flood, fire, tornado, hurricane, activities.’’ As discussed in § 3419.1 only informal education activities, as or drought; State and/or Institution Definitions, the use of the phrase authorized by statute. facing a financial crisis; or lack of ‘‘qualifying educational activities’’ has Under 7 U.S.C. 3221(a)(3), funds matching funds after demonstrating a caused confusion regarding what appropriated for extension must be used good faith effort to obtain funds. constitutes an allowable qualifying for the expenses of conducting § 3419.4 Application for waivers for educational activity. NIFA supports the extension programs and activities, and both 1890 land-grant institutions and position, as required under 2 CFR for contributing to the retirement of 1862 land-grant institutions in insular 200.306, that all matching funds must employees subject to the provisions of 7 areas. NIFA proposes to add § 3419.4 to be necessary and reasonable for U.S.C. 331. 7 U.S.C. 3222(e) expressly outline how 1890 land-grant institutions accomplishment of project or program prohibits extension funds from being and 1862 land-grant institutions in objectives. In other words, to be spent on college course teaching and insular areas may request a matching allowable as a match, the costs must be lectures in college. Section 1404(7) of waiver. To request a waiver, the allowable under the Federal award. This NARETPA defines the term extension to president of the institution must submit principle applies to matching funds mean informal education programs in writing a request for a waiver of the 1890 land-grant institutions receive for conducted in the States in cooperation matching requirements. The request Research and Extension programs, as with the Department of Education. must include the name of the eligible well as the funds received by 1862 land- Therefore, NIFA has determined that the institution, the type of capacity funds, grant institutions in insular areas for current authorizations allow for which would include Section 1444 Smith-Lever and Hatch programs. informal education programs to be Extension, Section 1445 Research; NIFA follows the authorized uses of conducted with extension funding, but Smith-Lever; or Hatch Act; the fiscal funds in the authorizing statutes for not for formal classroom instruction. year of the match; and the basis of the determining what is allowable under the 7 U.S.C. 3222(a)(3) states that: request, i.e., one or more of the criteria Federal award. For 1862 land-grant ‘‘research funding must be used for the identified in 3419.3. Requests for institutions in insular areas, this would expenses of conducting agricultural waivers may be submitted with the be the authorized uses under 7 U.S.C. research, printing, disseminating the
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results of such research, contributing to Regulatory Flexibility Act national government and the States, or the retirement of employees subject to This revised proposed rule has been on the distribution of power and the provisions of 7 U.S.C. 331 of this reviewed in accordance with the responsibilities among the various title, administrative planning and Regulatory Flexibility Act of 1980, as levels of government. As there is no direction, and purchase and rental of amended by the Small Business Federal mandate contained herein that land and the construction, acquisition, Regulatory Enforcement Fairness Act of could result in increased expenditures alteration, or repair of buildings 1996, (5 U.S.C. 601–612). The Director by State, local, or tribal governments, or necessary for conducting agricultural of the NIFA certifies that this proposed by the private sector, the Department research.’’ regulation will not have a significant has not prepared a budgetary impact Because the authorizing statutes so economic impact on a substantial statement. clearly identify authorized uses and number of small entities. This proposed Clarity of This Regulation regulation will affect institutions of prohibitions, NIFA believes that no Executive Order 12866 and the further explanation or inclusion of higher education receiving Federal funds under this program. The U.S. President’s Memorandum of June 1, qualifying educational activities is 1998, require each agency to write all needed in this regulation. Small Business Administration Size Standards define institutions as ‘‘small rulemaking in plain language. The § 3419.7 Reporting of matching entities’’ if they are for-profit or Department invites comments on how to funds. The revised proposed rule adds nonprofit institutions with total annual make this proposed rule easier to a section on reporting of matching funds revenue below $5,000,000 or if they are understand. to clarify an existing requirement that institutions controlled by governmental List of Subjects in 7 CFR Part 3419 1890 land-grant institutions and 1862 entities with populations below 50,000. land-grant institutions in insular areas The rulemaking does not involve Agricultural extension, Agricultural report all capacity funds expended on regulatory and informational research; 1890 land-grant institutions; an annual basis using Standard Form requirements regarding businesses, insular areas; 1862 land-grant (SF) 425, in accordance with 7 CFR part organizations, and governmental institutions in insular areas; matching 3430. This ensures that the information jurisdictions subject to regulation. funds. on matching funds is reported to NIFA. For the reasons stated in the Catalogue of Federal Domestic preamble, the National Institute of Food § 3419.8 Redistribution of funds. Assistance The revised proposed rule removes the and Agriculture rescinds the previous first sentence of the existing provision The programs affected by this revised Notice of Proposed Rulemaking RIN– as the timing of reapportionment may proposed rule are listed in the Catalogue 0524–AA25 issued April 29, 2003 (68 vary. Removing this sentence does not of Federal Domestic Assistance under FR 23013) and proposes to amend 7 CFR change the statutory requirements for 10.500, Cooperative Extension Service; part 3419 as follows: reapportionment. The only significance and 10.205, Payments to 1890 Land- Grant Colleges and Tuskegee University. PART 3419—MATCHING FUNDS of the deletion is to remove the July 1 REQUIREMENT FOR AGRICULTURAL date for action. Paperwork Reduction Act RESEARCH AND EXTENSION Additionally, one other technical The Department certifies that this CAPACITY FUNDS AT 1890 LAND- correction is changing ‘‘shall’’ to revised proposed rule has been assessed GRANT INSTITUTIONS, AND 1862 ‘‘must,’’ consistent with the plain in accordance with the requirements of LAND-GRANT INSTITUTIONS IN English provisions relating to the Paperwork Reduction Act (PRA), 44 INSULAR AREAS rulemaking. U.S.C. 3501 et seq. The Department concludes that this proposed rule does ■ 1. The authority citation for part 3419 Executive Order 12866 and Executive not impose any new information is revised to read as follows: Order 13563 collection requirements or change the Authority: 7 U.S.C. 3222d; 7 U.S.C. 343(e); Executive Orders 12866 and 13563 burden estimate on existing information 7 U.S.C. 361c; Pub. L. 107–171; Pub. L. 110– direct agencies to assess all costs and collection requirements. In addition to 234; Pub. L. 113–79 ■ benefits of available regulatory the SF–424 form families (i.e., Research 2. Amend § 3419.1 as follows: ■ alternatives and, if regulation is and Related and Mandatory) and the a. Add a definition for ‘‘Capacity necessary, to select regulatory SF–425 Federal Financial Report (FFR) funds’’; ■ approaches that maximize net benefits No. 0348–0061, NIFA has three b. Revise the definition of ‘‘Eligible (including potential economic, currently approved OMB information institution’’; ■ environmental, public health and safety collections associated with this c. Remove the definition of ‘‘Formula effects, distributive impacts, and rulemaking: OMB Information funds’’; Collection No. 0524- 0042, NIFA ■ equity). Executive Order 13563 d. Revise the definition of ‘‘Matching REEport; No. 0524–0041, NIFA emphasizes the importance of funds’’; Application Review Process; and No. ■ quantifying the costs and benefits of e. Remove the definition of 0524–0026, Organizational Information. simplifying and harmonizing rules, and ‘‘Qualifying educational activities’’ The addition and revisions read as of promoting flexibility. This Unfunded Mandates Reform Act of 1995 follows: rulemaking has been determined to be and Executive Order 13132 not significant for purposes of Executive The Department has reviewed this § 3419.1 Definitions. Order 12866. revised proposed rule in accordance As used in this part: Executive Order 13771 with the requirements of Executive Capacity funds means agricultural Order No. 13132 and the Unfunded extension and research funds provided This proposed rule is not expected to Mandates Reform Act of 1995, 2 U.S.C. by formula to the eligible institutions be an EO 13771 regulatory action 1501 et seq., and has found no potential under sections 1444 and 1445 of the because this rulemaking is not or substantial direct effects on the National Agricultural Research, significant under EO 12866. States, on the relationship between the Extension, and Teaching Policy Act of
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1977 (NARETPA), as amended, or under up to 100% of the matching funds § 3419.7 [Redesignated as § 3419.8] sections 3(b) and (c) of the Smith-Lever requirements in 7 CFR 3419.2 for any ■ 8. Redesignate § 3419.7 as § 3419.8, Act, 7 U.S.C. 343(b) and (c) or under fiscal year for an eligible institution in and add a new § 3419.7 to read as section 3 of the Hatch Act of 1887, 7 an insular area. follows: U.S.C. 361c. (c) The criteria to waive the § 3419.7 Reporting of matching funds. Eligible institution means a college or applicable matching requirement for university eligible to receive funds 1890 land-grant institutions and 1862 Institutions will report all capacity under the Act of August 30, 1890 (7 land-grant institutions in insular areas is matching funds expended annually U.S.C. 321 et seq.) (commonly known as demonstration of one or more of the using Standard Form (SF) 425, in the Second Morrill Act), including following: accordance with 7 CFR 3430.56(a). Central State University, Tuskegee ■ 9. Revise newly redesignated § 3419.8 University, and West Virginia State (1) Impacts from natural disaster, to read as follows: University (1890 land-grant flood, fire, tornado, hurricane, or § 3419.8 Redistribution of Funds. institutions), and a college or university drought; designated under the Act of July 2, 1862 (2) State and/or institution facing a Unmatched research and extension (7 U.S.C. 301, et seq.) (commonly financial crisis; or funds will be reapportioned in known as the First Morrill Act) and (3) Lack of matching funds after accordance with the research and located in the Commonwealth of Puerto demonstration of good faith efforts to extension statutory distribution Rico and the insular areas of American obtain funds. formulas applicable to the 1890 and Samoa, Guam, Micronesia, Northern 1862 land-grant institutions in insular (d) Approval or disapproval of the areas, respectively. Any redistribution Marianas, and the Virgin Islands (1862 request for a waiver will be based on the land-grant institutions in insular areas). of funds must be subject to the same application submitted, as defined under matching requirement under § 3419.2. Matching funds means funds from § 3419.4. non-Federal sources, including those Done at Washington, DC, on November 2, ■ 5. Add new § 3419.4 to read as made available by the State to the 2017. follows: eligible institutions, for programs or Sonny Ramaswamy, activities that fall within the purposes of § 3419.4 Applications for waivers for both NIFA Director, National Institute of Food and agricultural research and cooperative 1890 land-grant institutions and 1862 land- Agriculture. extension under: sections 1444 and grant institutions in insular areas. [FR Doc. 2017–24327 Filed 11–9–17; 8:45 am] 1445 of NARETPA; the Hatch Act of Application for waivers for both 1890 BILLING CODE 3410–22–P 1887; and the Smith-Lever Act. land-grant institutions and 1862 land- * * * * * grant institutions in insular areas. The ■ 2. Amend § 3419.2 as follows: president of the eligible institution must NATIONAL INDIAN GAMING ■ a. Remove the introductory text; submit any request for a waiver for COMMISSION ■ b. Revise Paragraphs (a) and (b). The revisions read as follows: matching requirements. A waiver application must include the name of 25 CFR Part 514 § 3419.2 Matching funds requirement. the eligible institution, the type of Fees (a) 1890 land-grant institutions: The Federal capacity funds (i.e. research, distribution of capacity funds are extension, Hatch, etc.), appropriate AGENCY: National Indian Gaming subject to a matching requirement. fiscal year, the basis for the request (e.g. Commission. Matching funds will equal not less than one or more of the criteria identified in ACTION: Proposed rule. 100% of the capacity funds to be § 3419.3); current supporting distributed to the institution. documentation, where current is SUMMARY: The National Indian Gaming (b) 1862 land-grant institutions in defined as within the past two years Commission proposes to amend its fee insular areas: The distribution of from the date of the letter requesting the regulations. The proposed rule would capacity funds are subject to a matching waiver; and the amount of the request. require the Commission to adopt annual requirement. Matching funds will equal fee rates no later than November 1 of not less than 50% of the capacity funds § 3419.5 [Amended] each year. In addition, the proposed rule to be distributed to the institution. ■ 6. Amend § 3419.5 by removing the defines the fiscal year of the gaming * * * * * word ‘‘formula’’ and adding, in its operation that will be used for place, the word ‘‘capacity’’. calculating the fee payments. Finally, § 3419.3 [Removed] ■ 7. Revise § 3419.6 to read as follows: the proposed rule includes additional ■ 3. Remove § 3419.3 revisions intended to clarify the fee § 3419.6 Use of matching funds. calculation and submission process for § 3419.4 [Redesignated as § 3419.3] gaming operations. ■ 4. Redesignate § 3419.4 as § 3419.3 The required matching funds for the DATES: The agency must receive and revise it to read as follows: capacity programs must be used by an eligible institution for the same purpose comments on or before December 28, § 3419.3 Limited waiver authority. as Federal award dollars: Agricultural 2017. (a) 1890 land-grant institutions: The research and extension activities that ADDRESSES: You may send comments by Secretary may waive the matching funds have been approved in the plan of work any of the following methods: requirement in 7 CFR 3419.2 above the required under sections 1445(c) and • Email: [email protected]. 50% level for any fiscal year for an 1444(d) of the National Agricultural • Fax: 202–632–7066. eligible institution of a State if the Research, Extension, and Teaching • Mail: National Indian Gaming Secretary determines that the State will Policy Act of 1977, section 7 of the Commission, 1849 C Street NW., MS be unlikely to satisfy the matching Hatch Act of 1887, and section 4 of the 1621, Washington, DC 20240. requirement. Smith-Lever Act. For all programs, • Hand Delivery: National Indian (b) 1862 land-grant institutions in tuition dollars and student fees may not Gaming Commission, 90 K Street NE., insular areas: The Secretary may waive be used as matching funds. Suite 200, Washington, DC 20002,
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between 9 a.m. and 5 p.m., Monday Commission believes that the current amendments intended to better describe through Friday, except Federal holidays. process would be improved by moving the intended fee calculation. These FOR FURTHER INFORMATION CONTACT: to an annual final fee rate announced on amendments include defining ‘‘assessed Austin Badger, National Indian Gaming or before November 1 of each year. This fiscal year.’’ Under the proposed rule, Commission; Telephone: 202–632–7003. change would improve the the annual fee shall be computed using Commission’s analysis and budgeting the ‘‘most recent rates of fees adopted by SUPPLEMENTARY INFORMATION: process and simplify the fee calculation the Commission’’ and ‘‘the assessable I. Comments Invited and payment process for gaming gross revenues for the gaming Interested parties are invited to operations, thereby reducing the operation’s assessed fiscal year.’’ Assessed fiscal year means the most participate in this proposed rulemaking frequency of error in fee calculation. recent fiscal year ending prior to by submitting such written data, views, Proposed changes to the fee regulations January 1 of the year the Commission or arguments as they may desire. were therefore included as a topic in a adopted fee rates. For example, if the Comments that provide the factual basis November 22, 2016, letter to tribal Commission adopted fee rates on supporting the views and suggestions leaders introducing the Commission’s November 1, 2018, the assessed fiscal presented are particularly helpful in 2017 consultation series. year would be a gaming operation’s developing reasoned regulatory III. Development of the Proposed Rule fiscal year ending prior to January 1, decisions on the proposal. On March 24, 2017, in Tulsa, OK, 2018. For gaming operations with fiscal II. Background April 5, 2017, in Scottsdale, AZ, April years ending December 31, the assessed 13, 2017, in San Diego, CA, April 20, fiscal year would be the fiscal year The Indian Gaming Regulatory Act 2017, in Billings, MT, May 4, 2017, in ending December 31, 2017. For gaming (IGRA or Act), Public Law 100–497, 25 Biloxi, MS, and on May 25, 2017, in operations with fiscal years ending U.S.C. 2701 et seq., was signed into law Portland, OR, the NIGC consulted with September 30, the assessed fiscal year on October 17, 1988. The Act tribes on the proposed change to the fee would be the fiscal year ending establishes the National Indian Gaming regulations. In addition, the September 30, 2017. For gaming Commission (NIGC or Commission) and Commission issued a discussion draft operations with fiscal years ending June sets out a comprehensive framework for on January 30, 2017, and solicited 30, the assessed fiscal year would be the the regulation of gaming on Indian written comments through July 1, 2017. fiscal year ending June 30, 2017. lands. The IGRA established an agency Comments received were generally As a result, under the proposed rule, funding framework whereby gaming supportive of the proposed change to if the Commission adopts a fee rate on operations licensed by tribes pay a fee the fee regulations. The Commission November 1, 2014 (Rate A), a different to the Commission for each gaming developed the proposed rule after fee rate on November 1, 2015 (Rate B), operation that conducts Class II or Class carefully considering the comments and the gaming operation’s fiscal year III gaming activity that is regulated by received. ends on December 31, the gaming IGRA. 25 U.S.C. 2717(a)(1). These fees operation’s quarterly payments would A. Assessed Fiscal Year are used to fund the Commission in be calculated as follows: (1) First quarter carrying out its regulatory authority. The current regulation provides that (of the gaming operation’s fiscal year), Fees are based on the gaming the annual fee shall be computed using payable March 31, 2015, would apply operation’s gross revenues. The rate of ‘‘the most recent rates of fees adopted by Rate A to the fiscal year ending fees is established annually by the the Commission’’ and ‘‘the assessable December 31, 2013, (2) Second quarter, Commission and shall be payable on a gross revenues for the previous fiscal payable June 30, 2015, would apply quarterly basis. 25 U.S.C. 2717(a)(3). year.’’ As a result, the fee rate applied Rate A to the fiscal year ending IGRA limits the total amount of fees to a gaming operation’s fiscal year December 31, 2013, (3) Third quarter, imposed during any fiscal year to 0.08 changes depending on when the gaming payable September 30, 2015, would percent of the gross gaming revenues of operation’s fiscal year ends. For apply Rate A to the fiscal year ending all gaming operations subject to example, if the Commission adopts a fee December 31, 2013, and (4) Fourth regulation under IGRA. Failure of a rate on November 1, 2014 (Rate A), a quarter, payable December 31, 2015, gaming operation to pay the fees different fee rate on November 1, 2015 would apply Rate B to the fiscal year imposed by the Commission’s fee (Rate B), and the gaming operation’s ending December 31, 2014. To continue schedule can be grounds for a civil fiscal year ends on December 31, the the example, the subsequent quarterly enforcement action. 25 U.S.C. gaming operations quarterly payments payment, payable March 31, 2016, 2713(a)(1). would be calculated as follows: (1) First would apply Rate B to the fiscal year The purpose of Part 514 is to establish quarter, payable March 31, 2015, would ending December 31, 2014. how the NIGC sets and collects those apply Rate A to the fiscal year ending As an additional example, under the fees, to establish a basic formula for December 31, 2014, (2) Second quarter, proposed rule, if the Commission adopts tribes to utilize in calculating the payable June 30, 2015, would apply a fee rate on November 1, 2014 (Rate A), amount of fees to pay, and to advise of Rate A to the fiscal year ending a different fee rate on November 1, 2015 the consequences for failure to pay the December 31, 2014, (3) Third quarter, (Rate B), and the gaming operation’s fees. Part 514 further establishes how payable September 30, 2015, would fiscal year ends on September 30, the the NIGC determines and assesses apply Rate A to the fiscal year ending gaming operation’s quarterly payments fingerprint processing fees. December 31, 2014, and (4) Fourth would be calculated as follows: (1) First Under the current fee regulations, the quarter, payable December 31, 2015, quarter (of the gaming operation’s fiscal Commission adopts a preliminary fee would apply Rate B to the fiscal year year), payable December 31, 2015, rate by March 1 and a final fee rate by ending December 31, 2014. would apply Rate A to the fiscal year June 1 of every year. In addition, the The Commission intends for the ending September 30, 2013, (2) Second NIGC annually reviews the costs annual rate to be applied consistently to quarter payable March 31, 2016, would involved in processing fingerprint cards a gaming operation’s assessable gross apply Rate A to the fiscal year ending and adopts a preliminary rate by March revenue for one fiscal year. The September 30, 2013, (3) Third quarter 1 and a final rate by June 1. The proposed rule therefore includes payable June 30, 2016, would apply
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Rate A to the fiscal year ending Commission within 120 days after the and 25 U.S.C. 2717(a)(6). The September 30, 2013, (4) Fourth quarter, end of the gaming operation’s fiscal Commission understands that the term payable September 30, 2016, would year. Therefore, under the proposed depreciation rather than amortization is apply Rate A to the fiscal year ending rule, audited financial statements for the appropriate for an allowance for capital September 30, 2013. To continue the assessed fiscal year are required to be expenditures for structures. The example, the subsequent first quarter, complete before a fee payment methods for determining the amount of payable December 31, 2016, would calculated using the assessed fiscal year the allowance provided for in section apply Rate B to the fiscal year ending is due. The current regulation and the 514.4(e) remains unchanged. September 30, 2014. proposed rule continue, however, to Comment: A commenter asked require that the quarterly statements whether the proposed rule would B. Fees and Statements Required if a must be reconciled with a tribe’s reduce fees for processing fingerprint Gaming Operation Ceases Operations audited or reviewed financial cards. In the course of developing the statements for each gaming location. Response: The proposed rule does not proposed rule, the Commission became E. Advanced Payment affect how the fees for processing aware that the current regulations do fingerprint cards are determined. As not describe the fees and statements Comment: A commenter sought provided by the current regulation and required of gaming operations that cease clarification as to whether the proposed rule, the fingerprint operations. Section 514.7(b) of the Commission would accept pre- processing fee is based on the fees proposed rule now provides that the payments under the proposed rule. charged by the Federal Bureau of gaming operation prepares and submits Response: The Commission accepts Investigation and the costs incurred by to the Commission the fees and pre-payments under the current the Commission. statements required for the period from regulations and will continue to do so the end of the most recent quarter for under the proposed rule. Section Regulatory Matters which fees have been paid through the 514.5(a) of the proposed rule provides Tribal Consultation date the gaming operation ceased that the annual fee payable to the operations. For example, if a gaming Commission optionally may be paid in The National Indian Gaming operation with a September 30 fiscal full in the first quarterly payment. Commission is committed to fulfilling its tribal consultation obligations— year end ceases operations on July 31, F. Other Comments 2017, the gaming operation will have whether directed by statute or submitted fees and statements through Comment: A commenter asked administrative action such as Executive June 30, 2017. The gaming operation whether the NIGC would issue late Order (E.O.) 13175 (Consultation and would therefore still owe a payment for payment fees instead of issuing a notice Coordination with Indian Tribal the period from July 1, 2017, through of violation when payments are Governments)—by adhering to the July 31, 2017. submitted late. consultation framework described in its Response: The Commission notes that Consultation Policy published July 15, C. Transition Period the current regulation provides for late 2013. The NIGC’s consultation policy Comment: Some commenters fees for payments submitted between specifies that it will consult with tribes recommended that the Commission take one and ninety calendar days late. on Commission Action with Tribal into account the transition period Statements and/or fee payments over Implications, which is defined as: Any between the current regulation and the ninety calendar days late constitute a Commission regulation, rulemaking, final rule, if adopted. failure to pay and may result in policy, guidance, legislative proposal, or Response: The Commission agrees enforcement action. The proposed rule operational activity that may have a and will issue guidance to describe how does not substantively amend the late substantial direct effect on an Indian gaming operations should calculate fee fee or failure to pay provisions of the tribe on matters including, but not payments during the transition period. current regulation. limited to the ability of an Indian tribe The Commission intends for the most Comment: A commenter asked to regulate its Indian gaming; an Indian recently announced fee rate to carry whether the Commission would amend Tribe’s formal relationship with the over until a new fee rate is announced the definition of assessable gross Commission; or the consideration of the once a final rule is promulgated. revenue to be consistent with standards Commission’s trust responsibilities to set by professional accounting Indian tribes. As discussed above, the D. Payment Adjustments organizations. NIGC engaged in extensive consultation Comment: Some commenters Response: The Commission on this topic and received and recommended that the proposed rule acknowledges that professional considered comments in developing this make clear the gaming operation’s accounting definitions of gross revenue proposed rule. obligations regarding underpayment or differ from the Commission’s definition overpayment of the annual fee. of assessable gross revenue. While the Regulatory Flexibility Act Response: The Commission agrees Commission’s definition of assessable The proposed rule will not have a that payment adjustments are warranted gross revenue must remain consistent significant impact on a substantial when the gaming operation becomes with the definition for gross revenues number of small entities as defined aware that prior submissions over or contained in IGRA at 25 U.S.C. under the Regulatory Flexibility Act, 5 underpaid the required fee amount. 2717(a)(6), the proposed rule includes U.S.C. 601, et seq. Moreover, Indian Section 514.6(d)(5) of the proposed rule one change intended to conform the Tribes are not considered to be small provides that the amount to be remitted Commission’s definition of assessable entities for the purposes of the be adjusted for prior amounts paid and gross revenue with appropriate Regulatory Flexibility Act. credits received, if applicable. The accounting terminology. The proposed Commission notes, however, that rule removes the word ‘‘amortization’’ Small Business Regulatory Enforcement pursuant to section 571.13 copies of from within the phrase ‘‘allowance for Fairness Act financial statements and audits are amortization of capital expenditures for The proposed rule is not a major rule required to have been provided to the structures’’ found in section 514.4(c) under 5 U.S.C. 804(2), the Small
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Business Regulatory Enforcement PART 514—FEES (2) No more than 5% of amounts in Fairness Act. The rule does not have an excess of the first $1,500,000 of the effect on the economy of $100 million Sec. assessable gross revenues from each or more. The rule will not cause a major 514.1 What is the purpose of this part? gaming operation. 514.2 When will the annual rates of fees be (b) If a tribe has a certificate of self- increase in costs or prices for published? consumers, individual industries, 514.3 What is the maximum fee rate? regulation, the rate of fees imposed on Federal, State, local government 514.4 How does a gaming operation assessable gross revenues from the class agencies or geographic regions. Nor will calculate the amount of the annual fee it II gaming activity shall be no more than the proposed rule have a significant owes? 0.25%. adverse effect on competition, 514.5 When must a gaming operation pay (c) The total amount of all fees employment, investment, productivity, its annual fees? imposed on assessable gross revenues innovation, or the ability of the 514.6 What are the quarterly statements that during any fiscal year shall not exceed must be submitted with the fee 0.08% of the assessable gross gaming enterprises, to compete with foreign payments? based enterprises. 514.7 What should a gaming operation do if revenues of all gaming operations. Unfunded Mandate Reform Act it changes its fiscal year or ceases § 514.4 How does a gaming operation operations? calculate the amount of the annual fee it The Commission, as an independent 514.8 Where should fees, quarterly owes? statements, and other communications regulatory agency, is exempt from (a) The amount of annual fees owed compliance with the Unfunded about fees be sent? 514.9 What happens if a gaming operation shall be computed using: Mandates Reform Act, 2 U.S.C. 1502(1); submits its fee payment or quarterly (1) The most recent rates of fees 2 U.S.C. 658(1). statement late? adopted by the Commission, and (2) The assessable gross revenues for Takings 514.10 When does a late payment or quarterly statement submission become a the gaming operation’s assessed fiscal In accordance with Executive Order failure to pay? year. 12630, the Commission has determined 514.11 Can a proposed late fee be appealed? (b) Assessed fiscal year means the that the proposed rule does not have 514.12 When does a notice of late gaming operation’s fiscal year ending submission and/or a proposed late fee prior to January 1 of the year the significant takings implications. A become a final order of the Commission takings implication assessment is not and final agency action? Commission adopted fee rates. required. 514.13 How are late submission fees paid, (c) For purposes of computing fees, and can interest be assessed? assessable gross revenues for each Civil Justice Reform 514.14 What happens if the fees imposed gaming operation are the total amount of In accordance with Executive Order exceed the statutory maximum or if the money wagered on class II and III Commission does not expend the full 12988, the Commission has determined games, plus entry fees (including table amount of fees collected in a fiscal year? or card fees), less any amounts paid out that the proposed rule does not unduly 514.15 May tribes submit fingerprint cards burden the judicial system and meets as prizes or paid for prizes awarded, and to the NIGC for processing? less an allowance for capital the requirements of section 3(a) and 514.16 How does the Commission adopt the 3(b)(2) of the Order. fingerprint processing fee? expenditures for structures as reflected 514.17 How are fingerprint processing fees in the gaming operation’s audited National Environmental Policy Act collected by the Commission? financial statements. (d) Assessable gross revenue tiers. The Commission has determined that Authority: 25 U.S.C. 2706, 2710, 2717, 2717a. Tier 1 assessable gross revenues are the the proposed rule does not constitute a first $1,500,000 of the assessable gross major federal action significantly § 514.1 What is the purpose of this part? revenues from each gaming operation. affecting the quality of the human Each gaming operation under the Tier 2 assessable gross revenues are the environment and that no detailed jurisdiction of the Commission, amounts in excess of the first $1,500,000 statement is required pursuant to the including a gaming operation operated of the assessable gross revenues from National Environmental Policy Act of by a tribe with a certificate of self- each gaming operation. 1969, 42 U.S.C. 4321, et seq. regulation, shall pay to the Commission (e) The allowance for capital Paperwork Reduction Act annual fees as established by the expenditures for structures shall be Commission. The Commission, by a either: The information collection vote of not less than two of its members, (1) An amount not to exceed 5% of requirements contained in this rule shall adopt the rates of fees to be paid. the cost of structures in use throughout were previously approved by the Office the assessed fiscal year and 2.5% of the of Management and Budget (OMB) as § 514.2 When will the annual rates of fees cost of structures in use during only a required by 44 U.S.C. 3501 et seq. and be published? part of the assessed fiscal year; or assigned OMB Control Number 3141– (a) The Commission shall adopt the (2) An amount not to exceed 10% of 0007, which expired in August of 2011. rates of fees no later than November 1st the total amount of depreciation The NIGC is in the process of reinstating of each year. expenses for the assessed fiscal year. that Control Number. (b) The Commission shall publish the (f) Unless otherwise provided by rates of fees in a notice in the Federal regulation, generally accepted List of Subjects in 25 CFR Part 514 Register. accounting principles shall be used. Gambling, Indian—lands, Indian— § 514.3 What is the maximum fee rate? § 514.5 When must a gaming operation tribal government, Reporting and (a) The rates of fees imposed shall pay its annual fees? recordkeeping requirements. be— (a) Annual fees are payable to the Therefore, for reasons stated in the (1) No more than 2.5% of the first Commission on a quarterly basis. The preamble, the National Indian Gaming $1,500,000 of the assessable gross annual fee payable to the Commission Commission proposes to revise 25 CFR revenues from each gaming operation, optionally may be paid in full in the part 514 to read as follows: and first quarterly payment.
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(b) Each gaming operation shall submit to the Commission the fees and (1) For statements and/or fee calculate the amount of fees to be paid, statements required by this subsection payments one (1) to thirty (30) calendar if any, and remit them with the for the stub period from the end of the days late, the Chair may propose a late quarterly statement required in § 514.6 previous fiscal year to the beginning of fee of up to, but not more than 10% of within three (3) months, six (6) months, the new fiscal year. The submission the fee amount for that quarter; must be sent to the Commission within nine (9) months, and twelve (12) months (2) For statements and/or fee ninety (90) days of its request. of the end of the gaming operation’s payments thirty-one (31) to sixty (60) fiscal year. (b) If a gaming operation ceases operations, it shall notify the calendar days late, the Chair may § 514.6 What are the quarterly statements Commission within (30) days. The propose a late fee of up to, but not more that must be submitted with the fee Commission may request that the than 15% of the fee amount for that payments? gaming operation, using the most recent quarter; (a) Each gaming operation shall file rates of fees adopted by the (3) For statements and/or fee with the Commission quarterly Commission, prepare and submit to the payments sixty-one (61) to ninety (90) statements showing its assessable gross Commission fees and statements for the calendar days late, the Chair may revenues for the assessed fiscal year. period from the end of the most recent propose a late fee of up to, but not more (b) These statements shall show the quarter for which fees have been paid to than 20% of the fee amount for that amounts derived from each type of the date operations ceased. The quarter. game, the amounts deducted for prizes, submission must be sent to the and the amounts deducted for the Commission within (90) days of its § 514.10 When does a late payment or allowance for capital expenditures for request. quarterly statement submission become a structures. failure to pay? § 514.8 Where should fees, quarterly (c) The quarterly statements shall Statements and/or fee payments over identify an individual or individuals to statements, and other communications about fees be sent? ninety (90) calendar days late constitute be contacted should the Commission Remittances, quarterly statements, a failure to pay the annual fee, as set need to communicate further with the forth in IGRA, 25 U.S.C. 2717(a)(4), and gaming operation. A telephone number and other communications about fees NIGC regulations, 25 CFR 573.4(a)(2). In and email address for each individual shall be sent to the Commission by the accordance with 25 U.S.C. 2717(a)(4), identified shall be included. methods provided for in the rates of fees failure to pay fees shall be grounds for (d) Each quarterly statement shall notice published in the Federal revocation of the approval of the Chair include the computation of the fees Register. of any license, ordinance or resolution payable, showing all amounts used in § 514.9 What happens if a gaming the calculations. The required required under IGRA for the operation operation submits its fee payment or of gaming. In accordance with calculations are as follows: quarterly statement late? § 573.4(a)(2) of this chapter, if a tribe, (1) Multiply the Tier 1 assessable (a) In the event that a gaming management contractor, or individually gross revenues by the rate for those operation fails to submit a fee payment owned gaming operation fails to pay the revenues adopted by the Commission. or quarterly statement in a timely annual fee, the Chair may issue a notice (2) Multiply the Tier 2 assessable manner, the Chair of the Commission of violation and, simultaneously with or gross revenues by the rate for those may issue a notice specifying: revenues adopted by the Commission. (1) The date the statement and/or subsequently to the notice of violation, (3) Add (total) the results (products) payment was due; a temporary closure order. obtained in paragraphs (d)(1) and (2) of (2) The number of calendar days late § 514.11 Can a proposed late fee be this section. the statement and/or payment was appealed? (4) Multiply the total obtained in submitted; paragraph (d)(3) of this section by 1⁄4. (3) A citation to the federal or tribal (a) Proposed late fees assessed by the (5) Adjust for prior amounts paid and requirement that has been or is being Chair may be appealed under credits received, if applicable. The violated; subchapter H of this chapter. gaming operation shall provide a (4) The action being considered by the (b) At any time prior to the filing of detailed justification for the adjustment. Chair; and a notice of appeal under subchapter H (5) Notice of rights of appeal pursuant (6) The amount computed in of this chapter, the Chair and the to subchapter H of this chapter. paragraph (d)(5) of this section is the recipient may agree to settle the notice amount to be remitted. (b) Within fifteen (15) days of service of the notice, the recipient may submit of late submission, including the (e) As required by part 571 of this amount of the proposed late fee. In the chapter, quarterly statements must be written information about the notice to the Chair. The Chair shall consider any event a settlement is reached, a reconciled with a tribe’s audited or settlement agreement shall be prepared reviewed financial statements for each information submitted by the recipient as well as the recipient’s history of and executed by the Chair and the gaming location. These reconciliations recipient. If a settlement agreement is must be made available upon the untimely submissions or failure to file statements and/or fee payments over the executed, the recipient shall be deemed request of any authorized representative to have waived all rights to further of the NIGC. preceding five (5) years in determining the amount of the late fee, if any. review of the notice or late fee in § 514.7 What should a gaming operation (c) When practicable, within thirty question, except as otherwise provided do if it changes its fiscal year or ceases (30) days of issuing the notice described expressly in the settlement agreement. operations? in paragraph (a) of this section to a In the absence of a settlement of the (a) If a gaming operation changes its recipient, the Chair of the Commission issues under this paragraph, the fiscal year, it shall notify the may assess a proposed late fee against recipient may contest the proposed late Commission of the change within thirty a recipient for each failure to file a fee before the Commission in (30) days. The Commission may request timely quarterly statement and/or fee accordance with subchapter H of this that the gaming operation prepare and payment: chapter.
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§ 514.12 When does a notice of late § 514.17 How are fingerprint processing ADDRESSES: For reasons of government submission and/or a proposed late fee fees collected by the Commission? efficiency, the Copyright Office is using become a final order of the Commission (a) Fees for processing fingerprint the regulations.gov system for the and final agency action? cards will be billed monthly to each submission and posting of public If the recipient fails to appeal under Tribe for cards processed during the comments in this proceeding. All subchapter H of this chapter, the notice prior month. Tribes shall pay the comments are therefore to be submitted and the proposed late fee shall become amount billed within forty-five (45) electronically through regulations.gov. a final order of the Commission and days of the date of the bill. Specific instructions for submitting final agency action. (b) The Chair may suspend fingerprint comments are available on the § 514.13 How are late submission fees card processing for a tribe that has a bill Copyright Office Web site at https:// paid, and can interest be assessed? remaining unpaid for more than forty- www.copyright.gov/rulemaking/ (a) Late fees assessed under this part five (45) days. groupunpublished/. If electronic shall be paid by the person or entity (c) Remittances and other submission of comments is not feasible assessed and shall not be treated as an communications about fingerprint due to lack of access to a computer and/ operating expense of the operation. processing fees shall be sent to the or the Internet, please contact the Office (b) The Commission shall transfer the Commission by the methods provided for special instructions using the contact late fee paid under this subchapter to for in the rates of fees notice published information below. the U.S. Treasury. in the Federal Register. FOR FURTHER INFORMATION CONTACT: (c) Interest shall be assessed at rates Dated: November 2, 2017. Robert J. Kasunic, Associate Register of established from time to time by the Jonodev O. Chaudhuri, Copyrights and Director of Registration Secretary of the Treasury on amounts Chairman. Policy and Practice; Erik Bertin, Deputy remaining unpaid after their due date. Kathryn Isom-Clause, Director of Registration Policy and Practice; or Regan A. Smith, Deputy § 514.14 What happens if the fees imposed Vice Chair. General Counsel, by telephone at 202– exceed the statutory maximum or if the E. Sequoyah Simermeyer, Commission does not expend the full 707–8040 or by email at [email protected], amount of fees collected in a fiscal year? Associate Commissioner. [email protected], and [email protected]. (a) The total amount of all fees [FR Doc. 2017–24363 Filed 11–9–17; 8:45 am] SUPPLEMENTARY INFORMATION: As imposed during any fiscal year shall not BILLING CODE 7565–01–P detailed in an October 12, 2017 notice exceed the statutory maximum imposed of proposed rulemaking (‘‘NPRM’’),1 the by Congress. The Commission shall U.S. Copyright Office is proposing to credit pro-rata any fees collected in LIBRARY OF CONGRESS create a new group registration option excess of this amount against amounts for a limited number of unpublished otherwise due. Copyright Office works (‘‘GRUW’’). Under that proposal, (b) To the extent that revenue derived applicants will be allowed to include up from fees imposed under the schedule 37 CFR Parts 201 and 202 to five works in each submission. This established under this paragraph are not [Docket No. 2017–15] new group registration option will expended or committed at the close of replace the current ‘‘unpublished any fiscal year, such funds shall remain Group Registration of Unpublished collections’’ option. available until expended to defray the Works: Extension of Comment Period After publication of the NPRM, there costs of operations of the Commission. was some understandable confusion AGENCY: U.S. Copyright Office, Library about the scope of the NPRM among the § 514.15 May tribes submit fingerprint of Congress. cards to the NIGC for processing? photographer community, who feared ACTION: Notice of proposed rulemaking; Tribes may submit fingerprint cards to that the GRUW option would limit them extension of comment period. the Commission for processing by the to submitting five unpublished Federal Bureau of Investigation and the photographs per application. To clarify, SUMMARY: The U.S. Copyright Office is the Office does not intend to impose Commission may charge a fee to process extending the deadlines for the fingerprint cards on behalf of the tribes. such a limit on photographers. On submission of written comments in December 1, 2016, the Office issued a § 514.16 How does the Commission adopt response to its October 12, 2017 notice separate notice of proposed rulemaking the fingerprint processing fee? of proposed rulemaking, regarding the amending the existing option for group (a) The Commission shall review creation of a new group registration registration of photographs that would annually the costs involved in option for unpublished works to replace create an electronic application for processing fingerprint cards and, by a the existing ‘‘unpublished collections’’ group registration for published vote of not less than two of its members, registration option. In this document, photographs, and also create an shall adopt the fingerprint processing the Office also clarifies that the new analogous application for group fee no later than November 1st of each group registration option is not intended registration for unpublished year. for group registration of unpublished photographs.2 Under that separate (b) The Commission shall publish the photographs; that is the subject of a proposed rule, photographers would be fingerprint processing fee in a notice in separate proposed rulemaking, which permitted to include up to 750 the Federal Register. would permit submission of up to 750 photographs on each such application, (c) The fingerprint processing fee photographs on one application. rather than the five works proposed shall be based on fees charged by the DATES: The comment period for the under the new GRUW option. See Federal Bureau of Investigation and notice of proposed rulemaking generally 81 FR at 86649. The Office is costs incurred by the Commission. published on October 12, 2017 (82 FR working on the group registration of Commission costs include Commission 47415), is extended. Comments must be photographs final rule in conjunction personnel, supplies, equipment costs, made in writing and must be received and postage to submit the results to the in the U.S. Copyright Office no later 1 82 FR 47415 (Oct. 12, 2017). requesting tribe. than November 17, 2017. 2 81 FR 86643 (Dec. 1, 2016).
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with the public comments received in confidential business information (CBI) I. Background that rulemaking. The Office fully or other information whose disclosure is A. NOX RACT for Cement Kilns intends to finalize that rule before restricted by statute. Multimedia finalizing the GRUW final rule. submissions (audio, video, etc.) must be On March 12, 2008, EPA strengthened Dated: November 7, 2017. accompanied by a written comment. the NAAQS for ground level ozone, setting both the primary and secondary Sarang V. Damle, The written comment is considered the official comment and should include standards to a level of 0.075 parts per General Counsel and Associate Register of million (ppm), or 75 parts per billion Copyrights. discussion of all points you wish to make. EPA will generally not consider (ppb), averaged over an 8-hour period [FR Doc. 2017–24511 Filed 11–9–17; 8:45 am] (hereafter referred to as the 2008 ozone comments or comment contents located BILLING CODE 1410–30–P NAAQS). On May 21, 2012 (77 FR outside of the primary submission (i.e. 30088), EPA designated 45 areas as on the web, cloud, or other file sharing nonattainment under the 2008 ozone ENVIRONMENTAL PROTECTION system). For additional submission NAAQS, including three areas or AGENCY methods, please contact the person portions of areas in Maryland. Under identified in the FOR FURTHER 40 CFR Part 52 section 182 of the CAA, states must INFORMATION CONTACT section. For the review and revise the RACT [EPA–R03–OAR–2016–0309; FRL–9968–49– full EPA public comment policy, requirements in their SIP to ensure that Region 3] information about CBI or multimedia these requirements would still be submissions, and general guidance on considered RACT under the new, more Approval and Promulgation of Air making effective comments, please visit stringent NAAQS. Major stationary Quality Implementation Plans; http://www2.epa.gov/dockets/ sources of ozone precursor emissions Maryland; Reasonably Available commenting-epa-dockets. located in ozone nonattainment areas Control Technology for Cement Kilns, classified as moderate and above (and Revisions to Portland Cement FOR FURTHER INFORMATION CONTACT: sources located in the Ozone Transport Manufacturing Plant and Natural Gas Marilyn Powers, (215) 814–2308, or by Region (OTR), of which the entire state Compression Station Regulations, and email at [email protected]. of Maryland is a part) are subject to Removal of Nitrogen Oxides Reduction SUPPLEMENTARY INFORMATION: On RACT requirements. See sections and Trading Program Replaced by 182(b)(2) and 184(b)(2) of the CAA. Other Programs and Regulations November 24, 2015, the State of Maryland, through the Maryland Section 182(f) of the CAA specifically AGENCY: Environmental Protection Department of the Environment (MDE), requires RACT for major stationary 2 Agency (EPA). submitted a SIP revision for approval sources of NOX. The cement kilns in ACTION: Proposed rule. into the Maryland SIP. The submission Maryland are major stationary sources is comprised of three State actions of NOX and are therefore required to be SUMMARY: The Environmental Protection pertaining to amendments to COMAR evaluated for NOX RACT under the 2008 Agency (EPA) is proposing to approve a 26.11.01.10, COMAR 26.11.09.08, ozone NAAQS. state implementation plan (SIP) revision submitted by the State of Maryland. COMAR 26.11.29, and COMAR B. Repeal of NOX Budget Trading This revision pertains to reasonably 26.11.30. The amendments address the Program Requirements Under the NOX available control technology (RACT) for requirement for NOX RACT for cement SIP Call cement kilns, revisions to and kilns for the 2008 ozone national In October 1998, EPA finalized the recodification of certain provisions for ambient air quality standard (NAAQS), ‘‘Finding of Significant Contribution Portland cement manufacturing plants the removal of COMAR provisions and Rulemaking for Certain States in the (cement plants) and internal combustion related to the obsolete NOX Budget Ozone Transport Assessment Group (IC) engines at natural gas compression Trading Program under the NOX SIP Region for Purposes of Reducing stations, and removal of the obsolete Call 1 (that has been replaced by other Regional Transport of Ozone’’— Nitrogen Oxides (NOX) Reduction and trading programs), the consolidation of commonly called the NOx SIP Call. The Trading Program that has been replaced all existing and new requirements for NOx SIP Call was designed to mitigate by other trading programs or addressed cement kilns into one COMAR significant transport of NOX, one of the in other regulations. This action is being regulation, the consolidation of all precursors of ozone. The NOX Budget taken under the Clean Air Act (CAA). existing and new requirements for IC Trading Program was established under DATES: Written comments must be engines into one COMAR regulation, the the NOX SIP Call to allow electric received on or before December 13, addition of new particulate matter (PM) generating units (EGUs) greater than 25 2017. monitoring requirements, and the megawatts and industrial non-electric ADDRESSES: Submit your comments, addition of an alternate monitoring generating units (or non-EGUs) with a identified by Docket ID No. EPA–R03– option for visible emissions at cement rated heat input greater than 250 million OAR–2016–0309 at http:// kilns. On February 17, 2017, MDE British thermal units per hour (MMBtu/ www.regulations.gov, or via email to provided a letter to EPA clarifying the hr) (referred to as large non-EGUs) to participate in a regional NOX cap and NOX RACT limits and withdrawing [email protected]. For comments 3 submitted at Regulations.gov, follow the from EPA’s consideration a provision of trade program. The NOX SIP call also
online instructions for submitting its regulation for natural gas 2 A major stationary source of NOX in a marginal comments. Once submitted, comments compression stations. or moderate ozone nonattainment area, or in an cannot be edited or removed from ozone transport region, is a source that emits or has the potential to emit 100 tons of NOX. Regulations.gov. For either manner of 1 See Finding of Significant Contribution and 3 In the cap and trade program established under submission, EPA may publish any Rulemaking for Certain States in the Ozone the NOX SIP Call, a regional ozone season NOX cap, comment received to its public docket. Transport Assessment Group Region for Purposes of or budget, was established, which was allocated as Do not submit electronically any Reducing Regional Transport of Ozone, 63 FR NOX allowances to subject sources in the affected information you consider to be 57371 (October 27, 1998). Continued
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5 established NOX reduction requirements separate rulemaking action. However, and on February 17, 2017, MDE for other non-EGUs that were not a part Maryland has identified additional large provided additional clarification on the of the NOX Budget Trading Program, non-EGUs that are subject to the NOX justification for the NOX RACT limits including cement kilns and stationary SIP Call at two sources, and is now for the cement kilns. As part of its IC engines. required to take regulatory action to re- submittal, MDE also provided an EPA discontinued administration of allocate the budget to cover both estimate of costs to comply with the the NOX Budget Trading Program in existing and new units. MDE is in the revised NOX rates for cement kilns, 2009 upon the start of the Clean Air process of developing a new regulation including the costs to install selective Interstate Rule (CAIR) trading to re-allocate the budget to include all non-catalytic reduction (SNCR) controls 4 programs. The NOX SIP Call units that are subject to the NOX SIP to meet the more stringent NOX rate requirements continued to apply, and Call. limits required by its May 21, 2010 EGUs that were previously trading The action in this notice pertains only regulatory action and the additional under the NOX Budget Trading Program to the cement kiln and IC engine costs to increase the amount of reagent continued to meet NOX SIP Call provisions, which were previously used in the SNCR to meet the requirements under the more stringent approved in COMAR 26.11.29 to requirements in its July 10, 2015 action requirements of the CAIR ozone season address NOX SIP Call requirements. further lowering the NOX emission rate. trading program. Certain large non- EPA agrees with Maryland’s II. Summary of SIP Revision and EPA EGUs were not addressed in CAIR. determination of NO RACT for cement Analysis X Therefore, states needed to assess their kilns for the 2008 ozone NAAQS, based state requirements and take regulatory Maryland’s submittal explained that on our analysis of the cost effectiveness action as necessary to ensure that all NOX RACT for cement kilns, which are associated with installation of SNCR, their non-EGU obligations continued to major stationary sources of NOX subject the cost effectiveness for additional be met. to RACT requirements, was established operating costs for the increase in Maryland regulations, COMAR consistent with the Ozone Transport ammonia use, as well as the 26.11.29—NOX Reduction Requirements Commission (OTC) recommended RACT technological considerations involved and Trading Program and COMAR requirements for the 2008 ozone with further increasing the amount of 26.11.30—Policies and Procedures NAAQS. The 2007 OTC Technical ammonia used. A more detailed Relating to Maryland’s NOX Reduction Support Document on Identification discussion of the NOX RACT limits for and Trading Program, were previously and Evaluation of Candidate Control the cement kilns and EPA’s analysis is approved into the Maryland SIP to Measures 6 (OTC TSD) recommended provided in the technical support implement the NOX Budget Trading NOX emission rates for cement kilns document (TSD) for this action, Program and allowed EGUs and large based on applying a 60 percent available in the docket for this non-EGUs in the state to participate in reduction to uncontrolled emissions. rulemaking at www.regulations.gov. the regional NOX cap and trade program There are two cement kilns in The November 24, 2015 SIP revision established under EPA’s NOX SIP Call. Maryland—a long, dry kiln in submittal also included several state COMAR 26.11.29 also included NOX Washington County (Lehigh Cement regulatory actions for inclusion into the reductions, monitoring, and Company) and a pre-calciner kiln in Maryland SIP. On May 21, 2010, recordkeeping requirements for cement Carroll County (Holcim Cement Plant). Maryland repealed COMAR 26.11.29 kilns and IC engines. After EPA Revised COMAR 26.11.30 establishes a and COMAR 26.11.30, with a State discontinued the NOX Budget Trading limit of 3.4 pounds (lbs) of NOX per ton effective date of May 31, 2010. The Program under the NOX SIP Call, of clinker (lbs NOX/ton of clinker) for requirements for large non-EGUs, Maryland’s EGU obligations under the long, dry kilns, and 2.4 lbs NOX/ton of cement kilns, and IC engines pursuant NOX SIP Call continued to be addressed clinker for pre-calciner kilns. It defines to the NOX SIP Call continue to apply, in Maryland regulation COMAR a pre-calciner kiln as a ‘‘cement kiln as noted previously. Therefore, 26.11.28—Clean Air Interstate Rule. that contains a pre-calciner at the Maryland recodified certain portions of However, in order to fill the gap for bottom of the pre-heater tower before the Portland cement plant and natural large non-EGUs created by the the materials enter the kiln,’’ and is gas compression station provisions discontinuance of the NOX Budget commonly referred to as a pre-heater/ (formerly found at COMAR 26.11.29.15) Trading Program upon implementation pre-calciner kiln. into new COMAR 26.11.29 (with a State of CAIR and then CSAPR, Maryland In its November 24, 2015 submittal, effective date of July 20, 2015), retitled needed to take regulatory action to MDE stated that the NOX emission rates NOX Reduction Requirements for Non- address NOX reduction requirements for for cement kilns are consistent with the Electric Generating Units. The cement its large non-EGUs. Maryland originally OTC recommendations for cement kilns, kiln provisions necessary to address the addressed these requirements for large NOX SIP Call requirements were revised non-EGUs as part of its regulation for 5 The NOX SIP Call requirements applicable to to add a compliance date of April 1, kraft pulp mills, and submitted large non-EGUs that were previously in COMAR 26.11.29 are now addressed in Maryland regulation 2017 for the existing NOX emission rate revisions to that regulation as a separate limits in the regulation and to remove SIP revision, for which EPA took COMAR 26.11.14—Control of Emissions from Kraft Pulp Mills, which MDE submitted to EPA as a an alternative control method. separate SIP revision submittal. See rulemaking COMAR 26.11.30 formerly included states. Each allowance equaled one ton of NOx, and docket EPA–R03–OAR–2016–0054 for Maryland allowances could be traded among sources. To submittal #14–04 dated October 8, 2014. EPA large non-EGUs as participants in the comply, sources were required to hold enough approved the submittal on July 17, 2017 (82 FR NOX Reduction and Trading Program allowances to cover their NOX emissions during the 32641). and established an ozone season 6 ozone season. The NOX limits adopted in Maryland’s July 10, allocation of 947 tons of NOX for the 4 CAIR was subsequently vacated and remanded. 2015 rulemaking were based on the 2007 ‘‘Ozone large non-EGUs at the only kraft pulp See North Carolina v. EPA, 531 F.3d 896 (D.C. Cir. Transport Commission (OTC) Technical Support 7 2008), modified by 550 F.3d 1176 (remanding Document on Identification and Evaluation of mill located in Maryland. With repeal CAIR). CAIR was replaced with the Cross-State Air Candidate Control Measures,’’ which was included Pollution Rule (CSAPR) (76 FR 48208, August 8, in the State’s submission and is available in the 7 40 CFR 97 Appendix C established Maryland’s 2011), which, after legal challenges, was docket for this proposed rulemaking action and large non-EGU budget as 1013 tons. The kraft pulp implemented starting in January 2015. online at www.regulations.gov. mill was allocated 947 tons, with the remainder of
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of the NOX Reduction and Trading (78 FR 10006, February 12, 2013). The rulemaking action and online at Program, Maryland modified its kraft revision requires performance testing www.regulations.gov. pulp mill regulation in COMAR using Method 5 or 5I to establish the III. Proposed Action 26.11.14.07 to limit NOX emissions from parameter to be monitored by the PM fuel burning equipment at kraft pulp continuous parametric monitoring EPA is proposing to approve mills to 947 tons per year (matching the system (CPMS). The PM CPMS will Maryland’s November 24, 2015 SIP ozone season allocation formerly in demonstrate continuing compliance 8 revision submittal, as clarified by its COMAR 26.11.30). While this with the PM emission limits established February 17, 2017 letter, pursuant to addresses the State’s current reduction in COMAR 26.11.30.04. As explained in sections 110, 182 and 184 of the CAA. requirements for large non-EGUs, if a more detail in EPA’s TSD, the revision EPA’s review of this material indicates new large non-EGU locates in the State strengthens the SIP by the addition of that Maryland’s November 24, 2015 at an existing or new kraft pulp mill, PM CPMS, and is at least as stringent as submittal, as clarified by its February Maryland would be required to the monitoring requirements for PM 17, 2017 letter, is approvable as it meets demonstrate that it is still meeting its previously approved in the Maryland requirements for NOX RACT for cement federal NOX SIP Call requirements. If a SIP for cement kilns. new large non-EGU locates in the state COMAR 26.11.30 also allows cement kilns for the 2008 ozone NAAQS under at a source other than a pulp mill, MDE kilns the option of using PM CPMS for sections 110, 182 and 184 of the CAA. must take regulatory action to re- monitoring visible emissions in lieu of EPA is also proposing to approve the allocate the non-EGU budget to cover all a continuous opacity monitor (COM) Maryland SIP submittal which includes large non-EGUs in the State, and require when a PM CPMS is installed and removal of regulations related to the 40 CFR part 75 monitoring for the new operated as specified in the rule. In the NOX Reduction and Trading Program non-EGU. Portland cement NESHAP, in under the NOX SIP Call as that trading On July 10, 2015, Maryland made disagreeing with industry commenters program is no longer operating as it has some additional regulatory who stated a preference for COMs, EPA been replaced by the CSAPR Update as modifications to both COMAR 26.11.29 explained that ‘‘PM CPMS has a clear noted previously. Thus, the Maryland and 26.11.30. COMAR 26.11.29 was advantage in low PM concentration regulations in the SIP which addressed revised to include only the provisions measurement over continuous opacity the NOX Reduction and Trading pertaining to IC engines and retitled monitoring systems’’ and that ‘‘the Program no longer provide emission Control of NOX Emissions from Natural CPMS is considerably more sensitive reductions. Additionally, EPA is Gas Pipeline Compression Stations. The than an opacity monitor or bag leak proposing to approve as part of the SIP provisions for Portland cement detector at detecting fluctuations in PM Maryland’s revised COMAR regulations manufacturing plants were removed level.’’ The revision in COMAR 26.11.30 that recodified certain requirements from COMAR 26.11.29 and recodified allowing the use of PM CPMS in lieu of applicable to Portland cement and consolidated with the requirements COMs is approvable under section 110 manufacturing plants and natural gas for cement kilns, which were previously of the CAA for the reasons noted above compression stations and added new scattered among other COMAR and as discussed in EPA’s TSD. EPA requirements for Portland cement plants regulations, into new COMAR does not expect it to interfere with and natural gas compression stations 26.11.30—Control of Portland Cement attainment of any of the NAAQS, with which are SIP strengthening under Manufacturing Plants (with a State reasonable further progress, or with any section 110 of the CAA. Finally, EPA is effective date of July 20, 2015). New other CAA requirement. proposing to approve a new regulatory COMAR 26.11.30 consolidates previous Finally, the November 24, 2015 provision for inclusion in the Maryland SIP approved requirements for PM, submittal proposed to remove from the SIP which creates new emission and NOX, sulfur dioxide (SO2), and visible Maryland SIP former COMAR monitoring requirements for cement emissions that apply to Portland cement provisions which implemented EPA’s kiln emissions as the new provision will manufacturing plants. NOX Budget Trading Program under the strengthen the Maryland SIP and is COMAR 26.11.30 also now contains NOX SIP Call as discussed in detail in approvable under section 110 of the revised provisions pertaining to PM EPA’s TSD for this rulemaking. EPA’s CAA. EPA is taking comments on the monitoring requirements. The SIP NOX Budget Trading Program under the issues discussed in this document. currently requires compliance with the NOX SIP Call is obsolete as it was These comments will be considered PM emission limits by stack tests using replaced by CAIR, which was before taking final action. Method 5 or 5I of 40 CFR part 60. The subsequently replaced by CSAPR in revision to COMAR 26.11.30 aligned the 2015 and the CSAPR Update in 2017. IV. Incorporation by Reference PM emissions monitoring requirements Therefore, the removal of the NOx with the monitoring requirements Budget Trading Program requirements In this proposed rulemaking action, applicable under the National Emission from the Maryland SIP that were EPA is proposing to include in a final Standards for Hazardous Air Pollutants formerly in COMAR 26.11.29 and .30 EPA rule, regulatory text that includes from the Portland Cement does not impact any of the NAAQS, incorporation by reference. In Manufacturing Industry, 40 CFR part 63, reasonable further progress or any other accordance with requirements of 1 CFR subpart LLL (Portland cement NESHAP) CAA requirements as those NOX 51.5, the EPA is proposing to reductions now are achieved through incorporate by reference the revisions to the budget reserved in a set-aside account for the CSAPR Update, and the removal is COMAR 26.01.10, COMAR 26.11.09.08, allocation to new sources. thus approvable under section 110(l) of COMAR 26.11.29 and COMAR 26.11.30 8 The NOX SIP Call requirements applicable to as described in this proposed large non-EGUs that were previously in COMAR the CAA. 26.11.30 are now addressed in Maryland regulation EPA’s TSD prepared for this proposed rulemaking action. These documents are COMAR 26.11.14—Control of Emissions from Kraft rulemaking action provides further available electronically through Pulp Mills, which was submitted to EPA as a detail on Maryland’s submittal and www.regulations.gov and/or may be separate SIP revision submittal, and for which EPA EPA’s analysis of Maryland’s SIP viewed at the appropriate EPA office is taking separate action. See rulemaking docket EPA–R03–OAR–2016–0054 for Maryland submittal revision submittal. EPA’s TSD is (see the ADDRESSES section of this #14–04 dated October 8, 2014. available in the docket for this preamble for more information).
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V. Statutory and Executive Order cement manufacturing plants in postmarked on or before December 13, Reviews Maryland regulations COMAR 26.11.29 2017. If you comment using the Federal Under the CAA, the Administrator is and COMAR 26.11.30 respectively, does eRulemaking Portal (see ADDRESSES), required to approve a SIP submission not have tribal implications as specified you must submit your comments by that complies with the provisions of the by Executive Order 13175 (65 FR 67249, 11:59 p.m. Eastern Time on the closing CAA and applicable Federal regulations. November 9, 2000). This is due to the date. 42 U.S.C. 7410(k); 40 CFR 52.02(a). fact that this SIP does not apply to ADDRESSES: You may submit comments Thus, in reviewing SIP submissions, Indian country, and therefore will not by one of the following methods: EPA’s role is to approve state choices, impose substantial direct costs on tribal (1) Federal eRulemaking Portal: provided that they meet the criteria of governments or preempt tribal law. http://www.regulations.gov. In the the CAA. Accordingly, this action List of Subjects in 40 CFR Part 52 Search box, enter the docket number for approves state law as meeting Federal this proposed rule, which is FWS–R8– Environmental protection, Air requirements and does not impose ES–2016–0078. Then click on the pollution control, Incorporation by additional requirements beyond those Search button. You may submit a reference, Nitrogen dioxide, Ozone, imposed by state law. For that reason, comment by clicking on ‘‘Comment Particulate matter, Reporting and this proposed action: Now!’’ Please ensure that you have recordkeeping requirements. • Is not a ‘‘significant regulatory found the correct rulemaking before action’’ subject to review by the Office Authority: 42 U.S.C. 7401 et seq. submitting your comment. (2) U.S. mail or hand delivery: Public of Management and Budget under Dated: October 25, 2017. Executive Orders 12866 (58 FR 51735, Comments Processing, Attn: Docket No. Cosmo Servidio, FWS–R8–ES–2016–0078; U.S. Fish and October 4, 1993) and 13563 (76 FR 3821, Regional Administrator, Region III. January 21, 2011); Wildlife Service, MS: BPHC; 5275 [FR Doc. 2017–24536 Filed 11–9–17; 8:45 am] • does not impose an information Leesburg Pike, Falls Church, VA 22041– collection burden under the provisions BILLING CODE 6560–50–P 3803. of the Paperwork Reduction Act (44 FOR FURTHER INFORMATION CONTACT: U.S.C. 3501 et seq.); Stephen P. Henry, Field Supervisor, • is certified as not having a DEPARTMENT OF THE INTERIOR U.S. Fish and Wildlife Service, Ventura significant economic impact on a Fish and Wildlife Office, 2493 Portola Fish and Wildlife Service substantial number of small entities Road, Ventura, CA 93003; telephone under the Regulatory Flexibility Act (5 805–644–5763; facsimile 805–644–3958. 50 CFR Part 17 U.S.C. 601 et seq.); Persons who use a telecommunications • does not contain any unfunded [Docket No. FWS–R8–ES–2016–0078; device for the deaf (TDD) may call the mandate or significantly or uniquely 4500030113] Federal Relay Service at 800–877–8339. affect small governments, as described RIN 1018–BB64 SUPPLEMENTARY INFORMATION: in the Unfunded Mandates Reform Act Background of 1995 (Pub. L. 104–4); Endangered and Threatened Wildlife • does not have federalism and Plants; Threatened Species Status On September 15, 2016, we published implications as specified in Executive for Chorizanthe parryi var. fernandina a proposed rule (81 FR 63454) to add Order 13132 (64 FR 43255, August 10, (San Fernando Valley Spineflower) Chorizanthe parryi var. fernandina as a 1999); threatened species to the List of • is not an economically significant AGENCY: Fish and Wildlife Service, Endangered and Threatened Plants regulatory action based on health or Interior. under the Endangered Species Act of safety risks subject to Executive Order ACTION: Proposed rule; reopening of the 1973, as amended (16 U.S.C. 1531 et 13045 (62 FR 19885, April 23, 1997); comment period. seq.). That proposal had a 60-day • is not a significant regulatory action comment period, ending November 16, subject to Executive Order 13211 (66 FR SUMMARY: We, the U.S. Fish and 2016. For a description of previous 28355, May 22, 2001); Wildlife Service (Service), announce Federal actions concerning C. parryi var. • is not subject to requirements of that a Candidate Conservation fernandina, please refer to the Section 12(d) of the National Agreement (CCA) has been prepared for September 15, 2016, proposed listing Technology Transfer and Advancement Chorizanthe parryi var. fernandina (San rule (81 FR 63454). On July 19, 2017, Act of 1995 (15 U.S.C. 272 note) because Fernando Valley spineflower). The CCA the Service announced a 6-month application of those requirements would was developed as a collaborative effort extension of the final determination of be inconsistent with the CAA; and between the Newhall Land and Farming whether to list the species as a result of • does not provide EPA with the Company (Newhall Land), a California scientific disagreement and uncertainty discretionary authority to address, as limited partnership, and the Service to (82 FR 33036), and reopened an appropriate, disproportionate human implement conservation measures for additional 30-day comment period. health or environmental effects, using the species. With the release of the CCA, Newhall Land and the Service have practicable and legally permissible we are reopening for an additional 30 developed a CCA to provide additional methods, under Executive Order 12898 days the comment period on the conservation measures for Chorizanthe (59 FR 7629, February 16, 1994). proposed rule to list C. parryi var. parryi var. fernandina. The CCA This rulemaking action proposing to fernandina as a threatened species. We provides for Newhall Land to approve NOX RACT for cement kilns for will submit a final listing determination voluntarily implement additional the 2008 ozone NAAQS; to remove to the Federal Register on or before conservation measures described in the Maryland’s NOX Reduction and Trading March 15, 2018. San Fernando Valley Spineflower Program regulations under the NOX SIP DATES: The comment period for the Enhancement and Introduction Plan Call; and to include revised and proposed rule that published September (Introduction Plan) with the goal of recodified provisions for natural gas 15, 2016, at 81 FR 63454 is reopened. enhancing the status of the species. The compression stations and Portland We will accept comments received or Introduction Plan provides for Newhall
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Land to voluntarily establish new, comment period on our proposed listing You may submit your comments and protected C. parryi var. fernandina for Chorizanthe parryi var. fernandina materials concerning the proposed rule occurrences within the species’ that was published in the Federal by one of the methods listed in historical range that will increase the Register on September 15, 2016 (81 FR ADDRESSES. We request that you send resiliency of the existing populations 63454) and the CCA. We will consider comments only by the methods and expand the redundancy and information and recommendations from described in ADDRESSES. representation of the species. Newhall all interested parties. We intend that If you submit information via http:// Land will voluntarily conserve an any final action resulting from the www.regulations.gov, your entire additional 1,498 acres of its property for proposal will be as accurate as possible submission—including any personal the benefit of the C. parryi var. and based on the best available identifying information—will be posted fernandina and carry out additional scientific and commercial data. on the Web site. If your submission is conservation activities within portions In consideration of the CCA, we are made via a hardcopy that includes of these 1,498 acres and within a particularly interested in new personal identifying information, you portion of the Petersen Ranch Mitigation information and comments regarding: may request at the top of your document Bank. Spineflower introduction will (1) The efficacy of seed introduction that we withhold this information from occur on a total of at least 10 acres for long-term establishment into public review. However, we cannot within the Additional Conservation suitable, unoccupied habitat of guarantee that we will be able to do so. Areas. These actions, collectively Chorizanthe or related taxa. We will post all hardcopy submissions known as the Additional Conservation (2) Whether the new areas proposed on http://www.regulations.gov. Measures, would contribute to reducing for seeding under the CCA will be Comments and materials we receive, and eliminating current and potential appropriate to support populations of as well as supporting documentation we future threats to the persistence of the Chorizanthe parryi var. fernandina. used in preparing the proposed rule, species by expanding the area of will be available for public inspection (3) Whether the Additional protected conservation land for the on http://www.regulations.gov, or by Conservation Areas and Measures plant, increasing the number and extent appointment, during normal business established under the Introduction Plan of protected C. parryi var. fernandina hours, at the U.S. Fish and Wildlife will afford sufficient resiliency, occurrence locations with outplanting, Service, Ventura Fish and Wildlife redundancy, and representation for the and providing protection for the Office (see FOR FURTHER INFORMATION conservation of the species. introduction sites from development- CONTACT). You may obtain copies of the related stressors with conservation If you previously submitted proposed rule at http:// easements and management actions. comments or information on the www.regulations.gov at Docket No. The Additional Conservation Measures September 15, 2016, proposed rule (81 FWS–R8–ES–2016–0078. Copies of the would result in at least two new, self- FR 63454) and/or the July 19, 2017, proposed rule are also available at sustaining, and persistent C. parryi var. reopening of the comment period on the http://www.fws.gov/cno/es//. fernandina occurrences and would proposed rule (82 FR 33036), please do not resubmit them. We have Authority: The authority for this action is increase the number of ecoregions in the Endangered Species Act of 1973, as which the species is represented. All incorporated previously submitted amended (16 U.S.C. 1531 et seq.). documents are posted to http:// comments into the public record, and Dated: October 4, 2017. www.regulations.gov in Docket No. we will fully consider them in the FWS–R8–ES–2016–0078. preparation of our final determination. Gregory Sheehan, Our final determination concerning the Acting Director, U.S. Fish and Wildlife Information Requested proposed listing will take into Service. We will accept written comments and consideration all written comments and [FR Doc. 2017–24474 Filed 11–9–17; 8:45 am] information during this reopened any additional information we receive. BILLING CODE 4333–15–P
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Notices Federal Register Vol. 82, No. 217
Monday, November 13, 2017
This section of the FEDERAL REGISTER Mailstop 9304, Washington, DC 20250. for OMB approval. All comments will contains documents other than rules or Please cite OMB Control No. 0505–0023. become a matter of public record. proposed rules that are applicable to the SUPPLEMENTARY INFORMATION: public. Notices of hearings and investigations, George M. Cabaniss Jr., committee meetings, agency decisions and Title: Guidelines for the Transfer of Director. rulings, delegations of authority, filing of Excess Computers or Other Technical [FR Doc. 2017–24479 Filed 11–9–17; 8:45 am] petitions and applications and agency Equipment Pursuant to Section 14220 of BILLING CODE 3410–TX–P statements of organization and functions are the 2008 Farm Bill. examples of documents appearing in this OMB Number: 0505–0023. section. Expiration Date of Approval: 03/31/ BROADCASTING BOARD OF 2018. GOVERNORS DEPARTMENT OF AGRICULTURE Type of Request: Extension and revision of a currently approved Government In The Sunshine Act Office of Procurement and Property information collection. Meeting Notice Management Abstract: USDA requires information in order to verify eligibility of DATE AND TIME: Wednesday, November Notice of Request for an Extension of requestors, determine availability of 15, 2017, 1:00 p.m. ET. a Currently Approved Information excess property, and have contact PLACE: Cohen Building, Room 3321, 330 Collection information for the requestor available Independence Ave. SW., Washington, to ensure an organization is designated DC 20237. AGENCY: Office of Procurement and to receive property on behalf of an SUBJECT: Notice of Meeting of the Property Management (OPPM), U.S. eligible recipient. Information will be Broadcasting Board of Governors. Department of Agriculture (USDA). used to coordinate the transfer of excess SUMMARY: The Broadcasting Board of ACTION: Notice and request for public property to eligible recipients. Governors (Board) will be meeting at the comments regarding an extension to an Respondents will be authorized time and location listed above. The existing OMB clearance. representatives of a city, town, or local Board will vote on a consent agenda consisting of the minutes of its August SUMMARY: In accordance with the government entity located in a rural area as defined in 7 U.S.C. 1991(a)(13)(A). 30, 2017 meeting, a resolution honoring Paperwork Reduction Act of 1995, this 35th Anniversary of Voice of America notice announces the Office of Estimate of Burden: Public reporting burden for this collection of information Broadcasts in Amharic-Language, and a Procurement and Property resolution proposing 2018 BBG Board Management’s intention to request an is estimated to average .167 hours per response. schedule. The Board will receive a extension of a currently approved report from the Chief Executive Officer information collection for Guidelines for Respondents: City, town, or local government entities located in a rural and Director of BBG. the Transfer of Excess Computers or This meeting will be available for area. Other Technical Equipment Pursuant to public observation via streamed Estimated Number of Respondents: Section 14220 of the 2008 Farm Bill. webcast, both live and on-demand, on 10. DATES: Comments on this notice must be the agency’s public Web site at received by January 12, 2018 to be Estimated Number of Responses per www.bbg.gov. Information regarding this assured of consideration. Respondent: 1. meeting, including any updates or ADDRESSES: You may submit comments Estimated Total Annual Burden on adjustments to its starting time, can also by any of the following methods: Respondents: 2 hours. be found on the agency’s public Web • Federal eRulemaking Portal: http:// Comments are invited on: (1) Whether site. www.regulations.gov. Follow the the proposed collection of information The public may also attend this instructions for sending comments. is necessary for the proper performance meeting in person at the address listed • Email: Sect14220.2008FarmBill@ of the functions of the agency, including above as seating capacity permits. dm.usda.gov. Include OMB Control No. whether the information will have Members of the public seeking to attend 0505–0023 in the subject line of the practical utility; (2) the accuracy of the the meeting in person must register at message. agency’s estimate of the burden of the https://bbgboardmeetingnovember2017. • Fax: (202) 720–8972. proposed collection of information eventbrite.com by 12:00 p.m. (ET) on • Mail: Office of Procurement and including the validity of the November 14. For more information, Property Management, Property methodology and assumptions used; (3) please contact BBG Public Affairs at Management Division, Attn: Michael R. ways to enhance the quality, utility, and (202) 203–4400 or by email at pubaff@ Johnson, 1400 Independence Ave. SW., clarity of the information to be bbg.gov. Suite 1575, Mailstop 9304, Washington, collected; and (4) ways to minimize the CONTACT PERSON FOR MORE INFORMATION: DC 20250. burden of the collection of information • Persons interested in obtaining more Hand Delivery/Courier: 1400 on those who are to respond, including information should contact Oanh Tran Independence Ave. SW., Suite 1575, the use of appropriate automated, at (202) 203–4545. Mailstop 9304, Washington, DC 20250. electronic, mechanical, or other FOR FURTHER INFORMATION CONTACT: Mr. technological collection techniques or Oanh Tran, Michael R. Johnson, OPPM at (202) 720– other forms of information technology. Managing Director. 9779 or by mail at USDA, OPPM, 1400 All responses to this notice will be [FR Doc. 2017–24643 Filed 11–8–17; 4:15 pm] Independence Ave. SW., Suite 1575, summarized and included in the request BILLING CODE 8610–01–P
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COMMISSION ON CIVIL RIGHTS meeting at https://facadatabase.gov/ port of entry. The proposed site is as committee/meetings.aspx?cid=235. follows: Proposed Site 1 (280.54 Notice of Public Meeting of the Arizona Please click on the ‘‘Meeting Details’’ acres)—Blimp Base, 7529 Blimp Base Advisory Committee and ‘‘Documents’’ links. Records Road, Hitchcock. If approved, the proposed site would be assigned a new AGENCY: U.S. Commission on Civil generated from this meeting may also be Rights. inspected and reproduced at the site number under FTZ 84. The Regional Programs Unit, as they become amended application is limited to FTZ ACTION: Announcement of meeting. available, both before and after the designation for the proposed Blimp Base SUMMARY: Notice is hereby given, meeting. Persons interested in the work site (i.e., it does not request authority for pursuant to the provisions of the rules of this Committee are directed to the the ASF service area originally proposed and regulations of the U.S. Commission Commission’s Web site, http:// in the application). on Civil Rights (Commission) and the www.usccr.gov, or may contact the Public comment is invited from Federal Advisory Committee Act Regional Programs Unit at the above interested parties. Submissions shall be (FACA) that a meeting of the Arizona email or street address. addressed to the Board’s Executive Secretary at: Foreign-Trade Zones Advisory Committee (Committee) to the Agenda Commission will be held at 2:00 p.m. Board, U.S. Department of Commerce, (Pacific Time) Friday, November 17, I. Welcome Room 21013, 1401 Constitution Ave. 2017. The purpose of the meeting is for II. Approval of minutes from November 1, NW., Washington, DC 20230. the Committee to deliberate on voting 2017 meeting The closing period for their receipt is rights project proposal and begin initial III. Review Project Proposal December 13, 2017. Rebuttal comments IV. Review Briefing Timeline in response to material submitted brainstorm. V. Brainstorm Venue location and Potential DATES: The meeting will be held on during the foregoing period may be Dates submitted during the subsequent 15-day Friday, November 17, 2017, at 2:00 p.m. VI. Next Steps PT VII. Adjournment period (to December 28, 2017). For further information, contact FOR FURTHER INFORMATION CONTACT: Ana Exceptional Circumstance: Pursuant Camille Evans at Camille.Evans@ Victoria Fortes (DFO) at afortes@ to 41 CFR 102–3.150, the notice for this trade.gov or (202) 482–2350. usccr.gov or (213) 894–3437. meeting is given less than 15 calendar Dated: November 6, 2017. SUPPLEMENTARY INFORMATION: This days prior to the meeting because of the meeting is available to the public exceptional circumstance of the Andrew McGilvray, through the following toll-free call-in committee needing to plan a briefing on Executive Secretary. number: 877–723–9521, conference ID voting rights to satisfy the U.S. [FR Doc. 2017–24518 Filed 11–9–17; 8:45 am] number: 7584074. Any interested Commission on Civil Rights’ 2018 BILLING CODE 3510–DS–P member of the public may call this Statutory Enforcement report timeline. number and listen to the meeting. Dated: November 7, 2017. Callers can expect to incur charges for DEPARTMENT OF COMMERCE calls they initiate over wireless lines, David Mussatt, International Trade Administration and the Commission will not refund any Supervisory Chief, Regional Programs Unit. incurred charges. Callers will incur no [FR Doc. 2017–24482 Filed 11–9–17; 8:45 am] [A–570–967] charge for calls they initiate over land- BILLING CODE P line connections to the toll-free Aluminum Extrusions From the telephone number. Persons with hearing People’s Republic of China: Final impairments may also follow the DEPARTMENT OF COMMERCE Results of Antidumping Duty proceedings by first calling the Federal Administrative Review; 2015–2016 Foreign-Trade Zones Board Relay Service at 1–800–977–8339 and AGENCY: Enforcement and Compliance, providing the Service with the [B–66–2015] International Trade Administration, conference call number and conference Department of Commerce. ID number. Proposed Foreign-Trade Zone— SUMMARY: The Department of Commerce Members of the public are entitled to Hitchcock, Texas; Amendment of (the Department) is conducting an make comments during the open period Application administrative review of the at the end of the meeting. Members of antidumping duty order on aluminum the public may also submit written A request has been submitted to the extrusions from the People’s Republic of comments; the comments must be Foreign-Trade Zones (FTZ) Board (the China (PRC). The period of review received in the Regional Programs Unit Board) by the Port of Houston Authority (POR) is May 1, 2015, through April 30, within 30 days following the meeting. (PHA), grantee of FTZ 84, at the request 2016. These final results cover 10 Written comments may be mailed to the of the City of Hitchcock, to amend the companies and the PRC-wide entity for Western Regional Office, U.S. City’s pending application requesting which an administrative review was Commission on Civil Rights, 300 North authority to establish a new foreign- initiated. Los Angeles Street, Suite 2010, Los trade zone in Hitchcock, Texas. The Angeles, CA 90012. They may be faxed pending application was docketed on DATES: Applicable: November 13, 2017. to the Commission at (213) 894–0508, or October 6, 2015 (FTZ Board Docket B– FOR FURTHER INFORMATION CONTACT: emailed Ana Victoria Fortes at afortes@ 66–2015, 80 FR 61358, October 13, Deborah Scott or Mark Flessner, AD/ usccr.gov. Persons who desire 2015). CVD Operations, Office VI, Enforcement additional information may contact the PHA is requesting authority to and Compliance, International Trade Regional Programs Unit at (213) 894– include the site originally proposed for Administration, Department of 3437. FTZ designation as part of a new zone Commerce, 1401 Constitution Avenue Records and documents discussed in Hitchcock, Texas as an additional NW., Washington, DC 20230; telephone: during the meeting will be available for magnet site of FTZ 84, adjacent to the (202) 482–2657 or (202) 482–6312, public viewing prior to and after the Houston Customs and Border Protection respectively.
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SUPPLEMENTARY INFORMATION: 7615.19.50, 7615.19.70, 7615.19.90, written description of the scope of this 7615.20.00, 7616.99.10, 7616.99.50, Order is dispositive. Background 8479.89.98, 8479.90.94, 8513.90.20, Analysis of Comments Received The Department initiated this review 9403.10.00, 9403.20.00, 7604.21.00.00, on July 7, 2016.1 On June 6, 2017, the 7604.29.10.00, 7604.29.30.10, All issues raised in the case briefs Department published the Preliminary 7604.29.30.50, 7604.29.50.30, filed by parties in this review are Results of this administrative review.2 7604.29.50.60, 7608.20.00.30, addressed in the Issues and Decision At that time, we invited interested 7608.20.00.90, 8302.10.30.00, Memorandum, which is incorporated parties to comment on the Preliminary 8302.10.60.30, 8302.10.60.60, herein by reference. A list of the issues Results. On July 6, 2017, we received a 8302.10.60.90, 8302.20.00.00, which any party raised, and to which case brief from the Aluminum 8302.30.30.10, 8302.30.30.60, we respond in the Issues and Decision Extrusions Fair Trade Committee (the 8302.41.30.00, 8302.41.60.15, Memorandum, follows in the appendix petitioner).3 No other parties submitted 8302.41.60.45, 8302.41.60.50, to this notice. The Issues and Decision case or rebuttal briefs. These final 8302.41.60.80, 8302.42.30.10, Memorandum is a public document and results cover 10 companies and the 8302.42.30.15, 8302.42.30.65, is on file electronically via Enforcement PRC-wide entity for which an 8302.49.60.35, 8302.49.60.45, and Compliance’s Antidumping and administrative review was initiated and 8302.49.60.55, 8302.49.60.85, Countervailing Duty Centralized not rescinded.4 8302.50.00.00, 8302.60.90.00, Electronic Service System (ACCESS). ACCESS is available to registered users Scope of the Order 8305.10.00.50, 8306.30.00.00, 8414.59.60.90, 8415.90.80.45, at https://access.trade.gov and is The merchandise covered by the 8418.99.80.05, 8418.99.80.50, available to all parties in the Central Order 5 is aluminum extrusions which 8418.99.80.60, 8419.90.10.00, Records Unit, Room B8024 of the main are shapes and forms, produced by an 8422.90.06.40, 8473.30.20.00, Department of Commerce building. In extrusion process, made from aluminum 8473.30.51.00, 8479.90.85.00, addition, a complete version of the alloys having metallic elements 8486.90.00.00, 8487.90.00.80, Issues and Decision Memorandum can corresponding to the alloy series 8503.00.95.20, 8508.70.00.00, be accessed directly on the Internet at designations published by The 8515.90.20.00, 8516.90.50.00, http://enforcement.trade.gov/frn/ Aluminum Association commencing 8516.90.80.50, 8517.70.00.00, index.html. The signed Issues and with the numbers 1, 3, and 6 (or 8529.90.73.00, 8529.90.97.60, Decision Memorandum and the proprietary equivalents or other 8536.90.80.85, 8538.10.00.00, electronic version of the Issues and certifying body equivalents).6 8543.90.88.80, 8708.29.50.60, Decision Memorandum are identical in Imports of the subject merchandise 8708.80.65.90, 8803.30.00.60, content. are provided for under the following 9013.90.50.00, 9013.90.90.00, Changes Since the Preliminary Results categories of the Harmonized Tariff 9401.90.50.81, 9403.90.10.40, For the purposes of these final results, Schedule of the United States (HTSUS): 9403.90.10.50, 9403.90.10.85, the Department made no changes to the 6603.90.8100, 7616.99.51, 8479.89.94, 9403.90.25.40, 9403.90.25.80, Preliminary Results. 8481.90.9060, 8481.90.9085, 9403.90.40.05, 9403.90.40.10, 9031.90.9195, 8424.90.9080, 9403.90.40.60, 9403.90.50.05, PRC-Wide Entity 9405.99.4020, 9031.90.90.95, 9403.90.50.10, 9403.90.50.80, For the purposes of the final results of 7616.10.90.90, 7609.00.00, 7610.10.00, 9403.90.60.05, 9403.90.60.10, this administrative review, the 7610.90.00, 7615.10.30, 7615.10.71, 9403.90.60.80, 9403.90.70.05, Department finds that the following 7615.10.91, 7615.19.10, 7615.19.30, 9403.90.70.10, 9403.90.70.80, entities are part of the PRC-wide entity 9403.90.80.10, 9403.90.80.15, because they failed to submit both a 1 See Initiation of Antidumping and 9403.90.80.20, 9403.90.80.41, Countervailing Duty Administrative Reviews, 81 FR Q&V response and information to 44260 (July 7, 2016) (Initiation Notice). 9403.90.80.51, 9403.90.80.61, establish eligibility for a separate rate: 2 See Aluminum Extrusions from the People’s 9506.11.40.80, 9506.51.40.00, (1) Kam Kiu; (2) Atlas Integrated Republic of China: Preliminary Results of 9506.51.60.00, 9506.59.40.40, Manufacturing Ltd.; (3) Classic & Antidumping Duty Administrative Review and 9506.70.20.90, 9506.91.00.10, Rescission of Review in Part; 2015–2016, 82 FR Contemporary Inc.; (4) Dongguan 26055 (June 6, 2017) (Preliminary Results), and 9506.91.00.20, 9506.91.00.30, Golden Tiger Hardware Industrial Co., accompanying preliminary decision memorandum 9506.99.05.10, 9506.99.05.20, Ltd.; (5) Jiaxing Jackson Travel Products (Preliminary Decision Memorandum). 9506.99.05.30, 9506.99.15.00, Co., Ltd.; (6) Taishan City Kam Kiu 3 See Petitioner Letter re: Aluminum Extrusions 9506.99.20.00, 9506.99.25.80, Aluminium Extrusion Co., Ltd.; (7) from the People’s Republic of China: Case Brief, 9506.99.28.00, 9506.99.55.00, dated July 6, 2017. Shenyang Yuanda Aluminium Industry 4 This administrative review initially covered 191 9506.99.60.80, 9507.30.20.00, Engineering Co. Ltd.; (8) Sincere Profit companies and the PRC-wide entity. See Initiation 9507.30.40.00, 9507.30.60.00, Limited; and (9) Suzhou New Hongji Notice, 81 FR at 44262. However, the Department 9507.90.60.00, and 9603.90.80.50. Precision Part Co. rescinded this review with respect to 181 companies for which all administrative review The subject merchandise entered as The Department’s change in policy requests were timely withdrawn. See Preliminary parts of other aluminum products may regarding conditional review of the Results, 82 FR at 26056. be classifiable under the following PRC-wide entity applies to this 5 See Aluminum Extrusions from the People’s additional Chapter 76 subheadings: administrative review.7 Under this Republic of China: Antidumping Duty Order, 76 FR 7610.10, 7610.90, 7615.19, 7615.20, and policy, the PRC-wide entity will not be 30650 (May 26, 2011) (Order). 6 For a complete description of the scope of the 7616.99, as well as under other HTSUS under review unless a party specifically Order, see Memorandum, ‘‘Issues and Decisions chapters. In addition, fin evaporator Memorandum for the Final Results of the coils may be classifiable under HTSUS 7 See Antidumping Proceedings: Announcement Antidumping Duty Administrative Review: numbers: 8418.99.80.50 and of Change in Department Practice for Respondent Aluminum Extrusions from the People’s Republic Selection in Antidumping Duty Proceedings and of China; 2015–2016,’’ dated concurrently with, and 8418.99.80.60. While HTSUS Conditional Review of the Nonmarket Economy hereby adopted by, this notice (Issues and Decision subheadings are provided for Entity in NME Antidumping Duty Proceedings, 78 Memorandum). convenience and customs purposes, the FR 65963, 65970 (November 4, 2013).
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requests, or the Department self- section 777A(f) of the Act for adjusted rate for tenKsolar is 85.96 initiates, a review of the entity. The countervailable domestic subsidies for percent. petitioner 8 requested a review of the the separate-rate recipients.9 Pursuant to section 772(c)(1)(C) of the PRC-wide entity in the instant review; Pursuant to section 772(c)(1)(C) of the Act, we also made an adjustment for therefore, the PRC-wide entity is Act, we made an adjustment for countervailable export subsidies for the currently under review and the rate for PRC-wide entity. We adjusted the PRC- countervailable export subsidies for the PRC-wide entity is subject to wide entity cash deposit rate by the tenKsolar. We calculated this change. lowest countervailable export subsidy adjustment as the simple average of the determined for the mandatory Adjustments for Countervailable countervailable export subsidies respondents in the 2014 (i.e., most Subsidies determined for the mandatory recently completed) CVD administrative Because no mandatory respondent respondents in the 2014 (i.e., most review.12 established eligibility for an adjustment recently completed) CVD administrative under section 777A(f) of the Act for review 10 and deducted this amount Final Results of Review countervailable domestic subsidies, the from the weighted-average dumping The Department determines that the Department, for these final results, did margin assigned to tenKsolar.11 The following weighted-average dumping not make an adjustment pursuant to margins exist for the 2015–2016 POR:
Margin adjusted Weighted-average for liquidation and Exporter dumping margin cash deposit (percent) purposes (percent)
tenKsolar (Shanghai) Co., Ltd ...... 86.01 85.96 PRC-wide Entity ...... 86.01 85.96
Additionally, as explained above, the rate.13 For the companies eligible for a which is 85.96 percent; and (4) for all Department determines that the separate rate, the Department will non-PRC exporters of subject following companies are part of the instruct CBP to assess antidumping merchandise which have not received PRC-wide entity: (1) Kam Kiu; (2) Atlas duties on the company’s entries of their own rate, the cash deposit rate will Integrated Manufacturing Ltd.; (3) subject merchandise at the rates listed be the rate applicable to the PRC Classic & Contemporary Inc.; (4) above in the section ‘‘Final Results of exporter that supplied that non-PRC Dongguan Golden Tiger Hardware Review.’’ exporter with the subject merchandise. Industrial Co., Ltd.; (5) Jiaxing Jackson These deposit requirements, when Travel Products Co., Ltd.; (6) Taishan Cash Deposit Requirements imposed, shall remain in effect until City Kam Kiu Aluminium Extrusion Co., The following cash deposit further notice. Ltd.; (7) Shenyang Yuanda Aluminium requirements will be effective upon Notification to Importers Industry Engineering Co. Ltd.; (8) publication of the final results of this This notice serves as a final reminder Sincere Profit Limited; and (9) Suzhou administrative review for all shipments New Hongji Precision Part Co. to importers of their responsibility of the subject merchandise from the PRC under 19 CFR 351.402(f)(2) to file a Assessment entered, or withdrawn from warehouse, certificate regarding the reimbursement for consumption on or after the of antidumping duties and/or Pursuant to section 751(a)(2)(A) of the publication date, as provided for by countervailing duties prior to Act and 19 CFR 351.212(b), the section 751(a)(2)(C) of the Act: (1) For liquidation of the relevant entries Department will determine, and CBP the companies eligible for a separate during this POR. Failure to comply with shall assess, antidumping duties on all rate, the cash deposit rate will that this requirement could result in the appropriate entries of subject listed above in the section ‘‘Final Department’s presumption that merchandise in accordance with the Results of Review;’’ (2) for previously reimbursement of antidumping duties final results of this review. The investigated or reviewed PRC and non- and/or countervailing duties occurred Department intends to issue assessment PRC exporters not listed above that and the subsequent assessment of instructions to CBP 15 days after the received a separate rate in a prior doubled antidumping duties. date of publication of the final results of segment of this proceeding, the cash review in the Federal Register. deposit rate will continue to be the Notification to Interested Parties Consistent with the Department’s exporter-specific rate published for the Regarding Administrative Protective assessment practice in NME cases, if the most-recently completed segment of this Order Department determines that an exporter proceeding in which the exporter was This notice also serves as the only under review had no shipments of reviewed; (3) for all PRC exporters of reminder to parties subject to subject merchandise, any suspended subject merchandise which have not administrative protective order (APO) of entries that entered under the exporter’s been found to be entitled to a separate their responsibility concerning the case number (i.e., at that exporter’s rate) rate, the cash deposit rate will be that disposition of proprietary information will be liquidated at the PRC-wide established for the PRC-wide entity, disclosed under APO in accordance
8 The petitioner is the Aluminum Extrusions Fair 10 Aluminum Extrusions from the People’s 12 Id., at 17–18. Trade Committee. Republic of China: Final Results and Partial 13 See Non-Market Economy Antidumping 9 See Preliminary Decision Memorandum, at 17– Rescission of Countervailing Duty Administrative Proceedings: Assessment of Antidumping Duties, 76 Review; 2014, 81 FR 92778 (December 20, 2016). 18. FR 65694 (October 24, 2011). 11 See Preliminary Decision Memorandum, at 12 and 17–18.
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with 19 CFR 351.305(a)(3), which 351.213(b), for administrative reviews of information and analysis, which often continues to govern business various antidumping and countervailing require follow-up questions and proprietary information in this segment duty orders and findings with analysis. Accordingly, the Department of the proceeding. Timely written September anniversary dates. will not conduct collapsing analyses at notification of the return or destruction All deadlines for the submission of the respondent selection phase of this of APO materials or conversion to various types of information, review and will not collapse companies judicial protective order is hereby certifications, or comments or actions by at the respondent selection phase unless requested. Failure to comply with the the Department discussed below refer to there has been a determination to regulations and the terms of an APO is the number of calendar days from the collapse certain companies in a a sanctionable violation. applicable starting time. previous segment of this antidumping We are issuing and publishing this Notice of No Sales proceeding (e.g., investigation, notice in accordance with sections administrative review, new shipper 751(a)(1) and 777(i)(1) of the Act and 19 If a producer or exporter named in review or changed circumstances CFR 351.213(h). this notice of initiation had no exports, review). For any company subject to this sales, or entries during the period of review, if the Department determined, Dated: November 3, 2017. review (POR), it must notify the Gary Taverman, or continued to treat, that company as Department within 30 days of collapsed with others, the Department Deputy Assistant Secretary for Antidumping publication of this notice in the Federal will assume that such companies and Countervailing Duty Operations, Register. All submissions must be filed performing the non-exclusive functions and continue to operate in the same manner electronically at http://access.trade.gov and will collapse them for respondent duties of the Assistant Secretary for in accordance with 19 CFR 351.303.1 Enforcement and Compliance. selection purposes. Otherwise, the Such submissions are subject to Department will not collapse companies verification in accordance with section Appendix—List of Topics Discussed in for purposes of respondent selection. 782(i) of the Tariff Act of 1930, as the Issues and Decision Memorandum Parties are requested to (a) identify amended (the Act). Further, in 1. Summary which companies subject to review accordance with 19 CFR 351.303(f)(1)(i), 2. Background previously were collapsed, and (b) a copy must be served on every party on 3. Scope of the Order provide a citation to the proceeding in the Department’s service list. 4. Discussion of the Issues which they were collapsed. Further, if Comment: The Margin Assigned to the Respondent Selection companies are requested to complete PRC-Wide Entity 5. Recommendation In the event the Department limits the the Quantity and Value (Q&V) number of respondents for individual Questionnaire for purposes of [FR Doc. 2017–24407 Filed 11–9–17; 8:45 am] respondent selection, in general each BILLING CODE 3510–DS–P examination for administrative reviews initiated pursuant to requests made for company must report volume and value the orders identified below, the data separately for itself. Parties should not include data for any other party, DEPARTMENT OF COMMERCE Department intends to select respondents based on U.S. Customs and even if they believe they should be International Trade Administration Border Protection (CBP) data for U.S. treated as a single entity with that other imports during the period of review. We party. If a company was collapsed with Initiation of Antidumping and intend to place the CBP data on the another company or companies in the Countervailing Duty Administrative record within five days of publication of most recently completed segment of this Reviews the initiation notice and to make our proceeding where the Department decision regarding respondent selection considered collapsing that entity, AGENCY: Enforcement and Compliance, within 30 days of publication of the complete Q&V data for that collapsed International Trade Administration, initiation Federal Register notice. entity must be submitted. Department of Commerce. Comments regarding the CBP data and SUMMARY: The Department of Commerce Deadline for Withdrawal of Request for respondent selection should be Administrative Review (the Department) has received requests submitted seven days after the to conduct administrative reviews of placement of the CBP data on the record Pursuant to 19 CFR 351.213(d)(1), a various antidumping and countervailing of this review. Parties wishing to submit party that has requested a review may duty orders and findings with rebuttal comments should submit those withdraw that request within 90 days of September anniversary dates. In comments five days after the deadline the date of publication of the notice of accordance with the Department’s for the initial comments. initiation of the requested review. The regulations, we are initiating those In the event the Department decides regulation provides that the Department administrative reviews. it is necessary to limit individual may extend this time if it is reasonable DATES: Applicable November 13, 2017. examination of respondents and to do so. In order to provide parties FOR FURTHER INFORMATION CONTACT: conduct respondent selection under additional certainty with respect to Brenda E. Waters, Office of AD/CVD section 777A(c)(2) of the Act: when the Department will exercise its Operations, Customs Liaison Unit, In general, the Department has found discretion to extend this 90-day Enforcement and Compliance, that determinations concerning whether deadline, interested parties are advised International Trade Administration, particular companies should be that the Department does not intend to U.S. Department of Commerce, 1401 ‘‘collapsed’’ (i.ee.g., treated as a single extend the 90-day deadline unless the Constitution Avenue NW., Washington, entity for purposes of calculating requestor demonstrates that an DC 20230, telephone: (202) 482–4735. antidumping duty rates) require a extraordinary circumstance has substantial amount of detailed SUPPLEMENTARY INFORMATION: prevented it from submitting a timely withdrawal request. Determinations by Background 1 See Antidumping and Countervailing Duty Proceedings: Electronic Filing Procedures; the Department to extend the 90-day The Department has received timely Administrative Protective Order Procedures, 76 FR deadline will be made on a case-by-case requests, in accordance with 19 CFR 39263 (July 6, 2011). basis.
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Separate Rates rate in the most recent segment of this rate in this proceeding. The Separate In proceedings involving non-market proceeding in which they participated, Rate Status Application will be economy (NME) countries, the to certify that they continue to meet the available on the Department’s Web site Department begins with a rebuttable criteria for obtaining a separate rate. The at http://enforcement.trade.gov/nme/ presumption that all companies within Separate Rate Certification form will be nme-sep-rate.html on the date of the country are subject to government available on the Department’s Web site publication of this Federal Register control and, thus, should be assigned a at http://enforcement.trade.gov/nme/ notice. In responding to the Separate single antidumping duty deposit rate. It nme-sep-rate.html on the date of Rate Status Application, refer to the is the Department’s policy to assign all publication of this Federal Register instructions contained in the exporters of merchandise subject to an notice. In responding to the application. Separate Rate Status administrative review in an NME certification, please follow the Applications are due to the Department country this single rate unless an ‘‘Instructions for Filing the no later than 30 calendar days of exporter can demonstrate that it is Certification’’ in the Separate Rate publication of this Federal Register sufficiently independent so as to be Certification. Separate Rate notice. The deadline and requirement entitled to a separate rate. Certifications are due to the Department for submitting a Separate Rate Status To establish whether a firm is no later than 30 calendar days after Application applies equally to NME- sufficiently independent from publication of this Federal Register owned firms, wholly foreign-owned government control of its export notice. The deadline and requirement firms, and foreign sellers that purchase activities to be entitled to a separate for submitting a Certification applies and export subject merchandise to the rate, the Department analyzes each equally to NME-owned firms, wholly United States. foreign-owned firms, and foreign sellers entity exporting the subject For exporters and producers who merchandise. In accordance with the who purchase and export subject submit a separate-rate status application separate rates criteria, the Department merchandise to the United States. or certification and subsequently are assigns separate rates to companies in Entities that currently do not have a selected as mandatory respondents, NME cases only if respondents can separate rate from a completed segment these exporters and producers will no demonstrate the absence of both de jure of the proceeding 2 should timely file a and de facto government control over Separate Rate Application to longer be eligible for separate rate status export activities. demonstrate eligibility for a separate unless they respond to all parts of the All firms listed below that wish to rate in this proceeding. In addition, questionnaire as mandatory qualify for separate rate status in the companies that received a separate rate respondents. administrative reviews involving NME in a completed segment of the Initiation of Reviews countries must complete, as proceeding that have subsequently appropriate, either a separate rate made changes, including, but not In accordance with 19 CFR application or certification, as described limited to, changes to corporate 351.221(c)(1)(i), we are initiating below. For these administrative reviews, structure, acquisitions of new administrative reviews of the following in order to demonstrate separate rate companies or facilities, or changes to antidumping and countervailing duty eligibility, the Department requires their official company name,3 should orders and findings. We intend to issue entities for whom a review was timely file a Separate Rate Application the final results of these reviews not requested, that were assigned a separate to demonstrate eligibility for a separate later than September 30, 2018.
Period to be reviewed
Antidumping Duty Proceedings India: Certain Lined Paper Products, A–533–843 ...... 9/1/16–8/31/17 Goldenpalm Manufacturers PVT Limited. Kokuyo Riddhi Paper Products Pvt. Ltd. Lodha Offset Limited. Lotus Global Private Limited. Magic International Pvt. Ltd. Marisa International. Navneet Education Ltd. Pioneer Stationery Pvt. Ltd. PP Bafna Ventures Private Limited. SAB International. SGM Paper Products. Super Impex. India: Cold-Rolled Steel Flat Products, A–533–865 ...... 3/7/16–8/31/17 Anil Special Steel Industries Ltd. Bhandari Foils & Tubes Ltd. Bhiwadi Metal Rollwell Pvt Ltd. Bhushan Power & Steel Ltd. Bhushan Steel Ltd. Bhusan Steel and Strips Limited. Bhuvee Profiles & Stainless Steel Pvt Ltd. BRG & Steel Pvt.
2 Such entities include entities that have not shipper review, etc.) and entities that lost their 3 Only changes to the official company name, participated in the proceeding, entities that were separate rate in the most recently completed rather than trade names, need to be addressed via preliminarily granted a separate rate in any segment of the proceeding in which they a Separate Rate Application. Information regarding currently incomplete segment of the proceeding participated. new trade names may be submitted via a Separate (e.g., an ongoing administrative review, new Rate Certification.
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Period to be reviewed
Disha Auto Components Pvt Ltd. Essar Steel Ltd. Fit-Wel Industries. Good Luck Steel Tubes Ltd. Hi-Tech Pipes Ltd. Indian Steel Corp. Ltd. IUP Jindal Metals & Alloys Ltd. Jai Corp Ltd. Jainex Ltd. Jindal Stainless Ltd. JSW Steel Limited. JSW Steel Coated Products Limited. JSW Ispat Steel Ltd. KR Steelunion Ltd. Lloyds Group. Mehta Alloys Ltd. Metalman Industries Ltd. National Steel & Agro Industries Ltd. Niko Steel Centre. POSCO India. Quality Foils (India) Pvt Ltd. Rabirun Vinimay Pvt Ltd. Rapsri Engineering Products Co Ltd. Real Strips Ltd. Rimjhim Ispat Ltd. RSAL—Ruchi Strips & Alloys Ltd. Sahu Refrigeration Industries Ltd. SAIL–Steel Authority of India Ltd. Sandvik Asia Ltd. Shah Alloys Ltd. Shresty India. Soni Ispat Ltd. Steel Corp. Steelco Gujarat Ltd. Stelco Ltd. Sunflag Iron & Steel Co Ltd. Surya Global Ltd. Swastik Pipes Ltd. Tarun International Ltd. Tata Steel Ltd. The Tinplate Co of India Ltd. Tube Products of India Ltd. Unichem Steel & Alloys Pvt Ltd. Uttam Galva Steels Ltd. Uttam Value Steels Ltd. Mexico: Certain Magnesia Carbon Bricks, A–201–837 ...... 9/1/16–8/31/17 RHI-Refmex SA de C.V. Vesuvius Mexico S.A. de C.V. Mexico: Heavy Walled Rectangular Welded Carbon Pipes and Tubes, A–201–847 ...... 3/1/16–8/31/17 Arco Metal S.A. de C.V. Forza Steel S.A. de C.V. Industrias Monterrey, S.A. de C.V. Maquilacero S.A. de C.V. Perfiles y Herrajes LM S.A. de C.V. Productos Laminados de Monterrey S.A. de C.V. PYTCO S.A. de C.V. Regiomontana de Perfiles y Tubos S.A. de C.V. Ternium S.A. de C.V. Tuberia Nacional S.A. de C.V. Tuberia Procarsa S.A. de C.V. Republic of Korea: Cold-Rolled Steel Flat Products, A–580–881 ...... 3/7/16–8/31/17 Ameri-Source Korea. Dongkuk Industries Co., Ltd. Dongbu Steel Co., Ltd. Dongkuk Steel Mill Co., Ltd. GS Gobal Corp. Hanawell Co., Ltd. Hankum Co., Ltd. Hyuk San Profile Co., Ltd. Hyundai Glovis Co., Ltd. Hyundai Steel Company. Kindus Inc. POSCO.
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Period to be reviewed
Daewoo International Corporation. Samsung C&T Corp. Steel N Future. Taihan Electric Wire Co., Ltd. Uin Global Co. Republic of Korea: Heavy Walled Rectangular Welded Carbon Pipes and Tubes, A–580–880 ...... 3/1/16–8/31/17 Ahshin Pipe & Tube Company. Bookook Steel Co., Ltd. Dongbu Steel Co., Ltd. Dong-A Steel Company. Histeel Co., Ltd. Husteel Co., Ltd. Hyundai Steel Pipe Company. Hyundai Steel Co. Miju Steel Manufacturing Co., Ltd. NEXTEEL Co., Ltd. Sam Kang Industries Co., Ltd. SeAH Steel Corporation. Kukje Steel Co., Ltd. Yujin Steel Industry Co. Ltd. Republic of Korea: Oil Country Tubular Goods, A–580–870 ...... 9/1/16–8/31/17 AJU Besteel Co., Ltd. BDP International. Daewoo International Corporation. Daewoo America. Dong-A Steel Co. Ltd. Dong Yang Steel Pipe. Dongbu Incheon Steel. DSEC. Erndtebruecker Eisenwerk and Company. Hansol Metal. Husteel Co., Ltd. HYSCO. Hyundai RB. Hyundai Steel Co., Ltd. Hyundai Steel Company. ILJIN Steel Corporation. Jim And Freight Co., Ltd. Kia Steel Co. Ltd. KSP Steel Company. Kukje Steel. Kurvers. NEXTEEL Co., Ltd. POSCO Daewoo Corporation. POSCO Daewoo America. Samsung. Samsung C and T Corporation. SeAH Besteel Corporation. SeAH Steel Corporation. Steel Canada. Sumitomo Corporation. TGS Pipe. Yonghyun Base Materials. ZEECO Asia. Taiwan: Narrow Woven Ribbons with Woven Selvedge, A–583–844 ...... 9/1/16–8/31/17 Banduoo Ltd. Fujian Rongshu Industry Co., Ltd. Ming Wei Co., Ltd. Roung Shu Industry Corporation. Xiamen Yi-He Textile Co., Ltd. The People’s Republic of China: Certain Steel Nails,4 A–570–909 ...... 8/1/16–7/31/17 The People’s Republic of China: Magnesia Carbon Bricks, A–570–954 ...... 9/1/16–8/31/16 Fedmet Resources Corporation. Fengchi Imp. and Exp. Co., Ltd. of Haicheng City. Fengchi Mining Co., Ltd. of Haicheng City. Fengchi Refractories Co., of Haicheng City. RHI Refractories Liaoning Co., Ltd. The People’s Republic of China: Freshwater Crawfish Tailmeat, A–570–848 ...... 9/1/16–8/31/17 China Kingdom (Beijing) Import & Export Co., Ltd. Deyan Aquatic Products and Food Co., Ltd. Hubei Nature Agriculture Industry Co., Ltd. Hubei Qianjiang Huashan Aquatic Food and Product Co., Ltd. Hubei Yuesheng Aquatic Products Co., Ltd.
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Period to be reviewed
Jingzhou Tianhe Aquatic Products Co., Ltd. Nanjing Gemsen International Co., Ltd. Shanghai Ocean Flavor International Trading Co., Ltd. Weishan Hongda Aquatic Food Co., Ltd. Xiping Opeck Food Co., Ltd. Xuzhou Jinjiang Foodstuffs Co., Ltd. Yancheng Hi-King Agriculture Developing Co., Ltd. The People’s Republic of China: New Pneumatic Off-the-Road Tires, A–570–912 ...... 9/1/16–8/31/17 Maxon Int’l Co., Limited. Tianjin Leviathan International Trade Co., Ltd. Weihai Zhongwei Rubber Co., Ltd. The People’s Republic of China: Raw Flexible Magnets, A–570–922 ...... 9/1/16–8/31/17 SOM International Limited. Wenzhou Haibao Printing Co., LTD. Turkey: Oil Country Tubular Goods, A–489–816 ...... 9/1/16–8/31/17 Cayirova Boru San A.S. C¸ ayirova Boru Sanayi ve Ticaret A.S¸ . and Yu¨cel Boru Ithalat-Ihracat ve Pazarlama A.S¸ . (collectively Yu¨cel). HG Tubulars Canada Ltd. Toscelik Profil ve Sac Endustrisi A.S. Tosyali Dis Ticaret A.S. Yucelboru Ihracat, Ithalat. United Kingdom: Cold-Rolled Steel Flat Products, A–412–824 ...... 3/7/16–8/31/17 Caparo Precision Strip, Ltd./Liberty Performance Steels Ltd.5. Countervailing Duty Proceedings India: Certain Lined Paper Products, C–533–844 ...... 1/1/16–12/31/16 Goldenpalm Manufacturers Pvt Limited. India: Cold-Rolled Steel Flat Products, C–533–866 ...... 9/16/16–12/31/16 Anil Special Steel Industries Ltd. Bhandari Foils & Tubes Ltd. Bhiwadi Metal Rollwell Pvt Ltd. Bhushan Power & Steel Ltd. Bhushan Steel Ltd. Bhusan Steel and Strips Limited. Bhuvee Profiles & Stainless Steel Pvt Ltd. BRG & Steel Pvt. Disha Auto Components Pvt Ltd. Essar Steel Ltd. Fit-Wel Industries. Good Luck Steel Tubes Ltd. Hi-Tech Pipes Ltd. Indian Steel Corp. Ltd. IUP Jindal Metals & Alloys Ltd. Jai Corp Ltd. Jainex Ltd. Jindal Stainless Ltd. JSW Steel Limited. JSW Steel Coated Products Limited. JSW Ispat Steel Ltd. KR Steelunion Ltd. Lloyds Group. Mehta Alloys Ltd. Metalman Industries Ltd. National Steel & Agro Industries Ltd. Niko Steel Centre. POSCO India. Quality Foils (India) Pvt Ltd. Rabirun Vinimay Pvt Ltd. Rapsri Engineering Products Co Ltd. Real Strips Ltd. Rimjhim Ispat Ltd. RSAL—Ruchi Strips & Alloys Ltd. Sahu Refrigeration Industries Ltd. SAIL- Steel Authority of India Ltd. Sandvik Asia Ltd. Shah Alloys Ltd. Shresty India. Soni Ispat Ltd. Steel Corp. Steelco Gujarat Ltd. Stelco Ltd. Sunflag Iron & Steel Co Ltd. Surya Global Ltd.
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Period to be reviewed
Swastik Pipes Ltd. Tarun International Ltd. Tata Steel Ltd. The Tinplate Co of India Ltd. Tube Products of India Ltd. Unichem Steel & Alloys Pvt Ltd. Uttam Galva Steels Ltd. Republic of Korea: Cold-Rolled Steel Flat Products, C–580–882 ...... 7/29/16–12/31/16 Dongbu Incheon Steel Co., Ltd. Dongkuk Industries Co., Ltd. Dongkuk Steel Mill Co., Ltd. Dongbu Steel Co., Ltd. Hyuk San Profile Co., Ltd. Hyundai Steel Co., Ltd. Hyundai Steel Company. POSCO. Taihan Electric Wire Co., Ltd. Union Steel Co., Ltd. The People’s Republic of China: Magnesia Carbon Bricks, C–570–955 ...... 1/1/16–12/31/16 Fedmet Resources Corporation. Fengchi Imp. and Exp. Co., Ltd. of Haicheng City. Fengchi Mining Co., Ltd. of Haicheng City. Fengchi Refractories Co., of Haicheng City. RHI Refractories Liaoning Co., Ltd. The People’s Republic of China: Narrow Woven Ribbons with Woven Selvedge, C–570–953 ...... 1/1/16–12/31/16 Yama Ribbons and Bows Co., Ltd. The People’s Republic of China: New Pneumatic Off-the-Road Tires, C–570–913 ...... 1/1/16–12/31/16 Techking Tires Limited. Tianjin Leviathan International Trade Co., Ltd. Shandong Huitong Tyre Co., Ltd. The People’s Republic of China: Raw Flexible Magnets, C–570–923 ...... 1/1/16–12/31/16 SOM International Limited. Wenzhou Haibao Printing Co., LTD. Turkey: Heavy Walled Rectangular Welded Carbon Steel Pipes and Tubes, C–489–825 ...... 12/28/15–4/25/16 9/12/16–12/31/16 Ozdemir Boru Profil San. Ve Tic. Ltd. Sti. Turkey: Oil Country Tubular Goods,6 C–489–817 ...... 1/1/16–12/31/16 Borusan Mannesmann Boru Sanayi ve Ticaret A.S. Borusan Istikbal Ticaret. Cayirova Boru San A.S. Cayirova Boru Sanayi ve Ticaret A.S. HG Tubulars Canada Ltd. Yucel Boru Ihracat ve Pazarlama A.S. Yucelboru Ihracat, Ithalat. Turkey: Oil Country Tubular Goods, C–489–817 ...... 1/1/16–12/31/16 Borusan Mannesmann Boru Sanayi ve Ticaret A.S. Borusan Istikbal Ticaret. Cayirova Boru San A.S. Cayirova Boru Sanayi ve Ticaret A.S. HG Tubulars Canada Ltd. Tosyali Dis Ticaret A.S. Yucel Boru Ihracat ve Pazarlama A.S. Yucelboru Ihracat, Ithalat.
Suspension Agreements Duty Absorption Reviews 351.218(f)(4) to continue an order or suspended investigation (after sunset None. During any administrative review covering all or part of a period falling review), the Secretary, if requested by a between the first and second or third domestic interested party within 30 4 In the initiation that published on October 16, days of the date of publication of the 2017 (82 FR 48051), the Department incorrectly and fourth anniversary of the identified that an administrative review was publication of an antidumping duty notice of initiation of the review, will initiated on the antidumping duty order of Certain order under 19 CFR 351.211 or a determine whether antidumping duties Steel Nails from the PRC for Shanxi Hairut Trade determination under 19 CFR have been absorbed by an exporter or Co. Ltd. The Department is now correcting that producer subject to the review if the notice: The Department is initiating administrative reviews on the antidumping duty order of Certain 6 The Department also received a request for subject merchandise is sold in the Steel Nails from the PRC for the following review of Tosyali Dis Ticaret A.S.. However, this United States through an importer that companies: (1) Shanxi Hairui Trade Co., Ltd.; and company was excluded from the CVD order as a is affiliated with such exporter or (2) Qingdao D&L Group Ltd. result of litigation. See Oil Country Tubular Goods producer. The request must include the 5 We have previously determined that Liberty from the Republic of Turkey: Amendment of Performance Steels Ltd. is the successor-in-interest Countervailing Duty Order, 82 FR 46483 (October name(s) of the exporter or producer for to Caparo Precision Strip, Ltd. 26, 2017). which the inquiry is requested.
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Gap Period Liquidation of that information.7 Parties are hereby filed requests for the extension of time reminded that revised certification limits. These modifications are effective For the first administrative review of requirements are in effect for company/ for all segments initiated on or after any order, there will be no assessment government officials as well as their October 21, 2013. Please review the of antidumping or countervailing duties representatives. All segments of any final rule, available at http:// on entries of subject merchandise antidumping duty or countervailing www.gpo.gov/fdsys/pkg/FR–2013–09– entered, or withdrawn from warehouse, duty proceedings initiated on or after 20/html/2013–22853.htm, prior to for consumption during the relevant August 16, 2013, should use the formats submitting factual information in these provisional-measures ‘‘gap’’ period, of for the revised certifications provided at segments. the order, if such a gap period is the end of the Final Rule.8 The These initiations and this notice are applicable to the POR. Department intends to reject factual in accordance with section 751(a) of the Administrative Protective Orders and submissions in any proceeding Act (19 U.S.C. 1675(a)) and 19 CFR Letters of Appearance segments if the submitting party does 351.221(c)(1)(i). not comply with applicable revised Dated: November 3, 2017. Interested parties must submit certification requirements. applications for disclosure under James Maeder, administrative protective orders in Extension of Time Limits Regulation Senior Director perfoming the duties of accordance with the procedures Parties may request an extension of Deputy Assistant Secretary for Antidumping outlined in the Department’s regulations time limits before a time limit and Countervailing Duty Operations. at 19 CFR 351.305. Those procedures established under Part 351 expires, or as [FR Doc. 2017–24517 Filed 11–9–17; 8:45 am] apply to administrative reviews otherwise specified by the Secretary. BILLING CODE P included in this notice of initiation. See 19 CFR 351.302. In general, an Parties wishing to participate in any of extension request will be considered these administrative reviews should untimely if it is filed after the time limit DEPARTMENT OF COMMERCE established under Part 351 expires. For ensure that they meet the requirements International Trade Administration of these procedures (e.g., the filing of submissions which are due from separate letters of appearance as multiple parties simultaneously, an [A–570–910] discussed at 19 CFR 351.103(d)). extension request will be considered untimely if it is filed after 10:00 a.m. on Circular Welded Carbon Quality Steel Factual Information Requirements the due date. Examples include, but are Pipe From the People’s Republic of China: Rescission of Antidumping The Department’s regulations identify not limited to: (1) Case and rebuttal Duty Administrative Review; 2016– five categories of factual information in briefs, filed pursuant to 19 CFR 351.309; 2017 19 CFR 351.102(b)(21), which are (2) factual information to value factors summarized as follows: (i) Evidence under 19 CFR 351.408(c), or to measure AGENCY: Enforcement and Compliance, submitted in response to questionnaires; the adequacy of remuneration under 19 International Trade Administration, (ii) evidence submitted in support of CFR 351.511(a)(2), filed pursuant to 19 Department of Commerce. allegations; (iii) publicly available CFR 351.301(c)(3) and rebuttal, clarification and correction filed SUMMARY: The Department of Commerce information to value factors under 19 (the Department) is rescinding the CFR 351.408(c) or to measure the pursuant to 19 CFR 351.301(c)(3)(iv); (3) comments concerning the selection of a administrative review of the adequacy of remuneration under 19 CFR antidumping duty order on circular 351.511(a)(2); (iv) evidence placed on surrogate country and surrogate values and rebuttal; (4) comments concerning welded carbon quality steel pipe from the record by the Department; and (v) the People’s Republic of China (PRC) evidence other than factual information U.S. Customs and Border Protection data; and (5) quantity and value covering the period July 1, 2016, described in (i)–(iv). These regulations through June 30, 2017. require any party, when submitting questionnaires. Under certain DATES: factual information, to specify under circumstances, the Department may Applicable November 13, 2017. which subsection of 19 CFR elect to specify a different time limit by FOR FURTHER INFORMATION CONTACT: Eli 351.102(b)(21) the information is being which extension requests will be Lovely, AD/CVD Operations, Office IV, submitted and, if the information is considered untimely for submissions Enforcement & Compliance, submitted to rebut, clarify, or correct which are due from multiple parties International Trade Administration, factual information already on the simultaneously. In such a case, the Department of Commerce, 1401 record, to provide an explanation Department will inform parties in the Constitution Avenue NW., Washington, identifying the information already on letter or memorandum setting forth the DC 20230; telephone: (202) 482–1593. the record that the factual information deadline (including a specified time) by SUPPLEMENTARY INFORMATION: seeks to rebut, clarify, or correct. The which extension requests must be filed Background regulations, at 19 CFR 351.301, also to be considered timely. This provide specific time limits for such modification also requires that an On September 13, 2017, based on a factual submissions based on the type of extension request must be made in a timely request by Zekelman Industries factual information being submitted. separate, stand-alone submission, and (Zekelman), the Department published Please review the final rule, available at clarifies the circumstances under which in the Federal Register a notice of http://enforcement.trade.gov/frn/2013/ the Department will grant untimely- initiation of an administrative review of 1304frn/2013–08227.txt, prior to the antidumping duty order on circular submitting factual information in this 7 See section 782(b) of the Act. welded carbon quality steel pipe from 8 See Certification of Factual Information To the PRC with respect to 20 companies.1 segment. Import Administration During Antidumping and Any party submitting factual Countervailing Duty Proceedings, 78 FR 42678 (July On September 29, 2017, pursuant to 19 information in an antidumping duty or 17, 2013) (Final Rule); see also the frequently asked questions regarding the Final Rule, available at 1 See Initiation of Antidumping and countervailing duty proceeding must http://enforcement.trade.gov/tlei/notices/factual_ Countervailing Duty Administrative Reviews, 82 FR certify to the accuracy and completeness info_final_rule_FAQ_07172013.pdf. 42974 (September 13, 2017).
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CFR 351.213(d)(1), Zekelman timely return or destruction of proprietary U.S. Department of Commerce, 1401 withdrew its request for an information disclosed under APO in Constitution Avenue NW., Washington, administrative review of all 20 accordance with 19 CFR 351.305, which DC 20230; telephone (202) 482–0410. companies.2 continues to govern business SUPPLEMENTARY INFORMATION: proprietary information in this segment Rescission of Administrative Review of the proceeding. Timely written Background Pursuant to 19 CFR 351.213(d)(1), the notification of the return or destruction On June 26, 2000, and August 10, Department will rescind an of APO materials, or conversion to 2000, the Department published the AD administrative review, in whole or in judicial protective order, is hereby orders on large diameter pipe from part, if the party that requested the requested. Failure to comply with the Japan and small diameter pipe from review withdraws the requests within regulations and terms of an APO is a Japan and Romania, respectively.1 On 90 days of the date of publication of the violation which is subject to sanction. September 1, 2016, the Department notice of initiation of the requested published the notice of initiation of the Notification to Interested Parties review. Zekelman withdrew its review third sunset review of the antidumping request by the 90-day deadline, and no This notice is issued and published in duty orders on large diameter pipe from other parties requested an accordance with sections 751(a)(1) and Japan and small diameter pipe from administrative review of this order. 777(i)(1) of the Tariff Act of 1930, as Japan and Romania pursuant to section Therefore, we are rescinding the amended, and 19 CFR 351.213(d)(4). 751(c) of the Tariff Act of 1930, as administrative review of the Dated: November 6, 2017. amended (the Act).2 On December 16, antidumping duty order on circular James Maeder, 2016, the USITC instituted its review of welded carbon quality steel pipe from 3 Senior Director performing the duties of the orders. the PRC covering the period July 1, 2016 As a result of its review, the to June 30, 2017, in its entirety. Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations. Department determined that revocation Assessment [FR Doc. 2017–24514 Filed 11–9–17; 8:45 a.m.] of the antidumping duty orders on large diameter pipe from Japan and small The Department will instruct U.S. BILLING CODE 3510–DS–P diameter pipe from Japan and Romania Customs and Border Protection (CBP) to would likely lead to continuation or assess antidumping duties on all recurrence of dumping and, therefore, appropriate entries. Because the DEPARTMENT OF COMMERCE notified the USITC of the magnitude of Department is rescinding this International Trade Administration the margins of dumping likely to prevail administrative review in its entirety, the should the orders be revoked.4 entries to which this administrative [A–588–850, A–588–851, A–485–805] On October 16, 2017, the USITC review pertains shall be assessed published its determination, pursuant to antidumping duties that are equal to the Certain Large Diameter Carbon and section 751(c)(1) of the Act, that cash deposits of estimated antidumping Alloy Seamless Standard, Line and revocation of the antidumping duty duties required at the time of entry, or Pressure Pipe From Japan; Certain orders on large diameter pipe from withdrawal from warehouse, for Small Diameter Carbon and Alloy Japan and small diameter pipe from consumption, in accordance with 19 Seamless Standard, Line and Pressure Japan and Romania would be likely to CFR 351.212(c)(1)(i). The Department Pipe From Japan and Romania: lead to continuation or recurrence of intends to issue appropriate assessment Continuation of Antidumping Duty material injury to an industry in the instructions to CBP within 15 days after Orders United States within a reasonably the publication of this notice in the AGENCY: Enforcement and Compliance, foreseeable time.5 Federal Register. International Trade Administration, Notification to Importers Department of Commerce. 1 See Notice of Antidumping Duty Orders: Certain DATES: Applicable November 13, 2017. Large Diameter Carbon and Alloy Seamless This notice serves as the only Standard, Line and Pressure Pipe from Japan; and SUMMARY: reminder to importers of their As a result of the Certain Small Diameter Carbon and Alloy Seamless responsibility under 19 CFR determinations by the Department of Standard, Line and Pressure Pipe from Japan and 351.402(f)(2) to file a certificate Commerce (the Department) and the the Republic of South Africa, 65 FR 39360 (June 26, U.S. International Trade Commission 2000), and Notice of Amended Final Determination regarding the reimbursement of of Sales at Less Than Fair Value and Antidumping antidumping duties prior to liquidation (USITC) that revocation of the Duty Order: Certain Small Diameter Carbon and of the relevant entries during this antidumping duty orders on certain Alloy Seamless Standard, Line and Pressure Pipe review period. Failure to comply with large diameter carbon and alloy from Romania, 65 FR 48963 (August 10, 2000). 2 See Initiation of Five-Year (Sunset) Reviews, 81 this requirement could result in the seamless standard, line and pressure pipe (large diameter pipe) from Japan FR 60343 (September 1, 2016). presumption that reimbursement of the 3 See Carbon and Alloy Seamless Standard, Line, antidumping duties occurred and the and certain small diameter carbon and and Pressure Pipe from Japan and Romania subsequent assessment of doubled alloy seamless standard, line and Institution of Five-Year Reviews; Notice of antidumping duties. pressure pipe (small diameter pipe) Commission Determination to Conduct Full Five from Japan and Romania would likely Year Reviews, 81 FR 91199 (December 16, 2016). 4 Administrative Protective Orders lead to continuation or recurrence of See Certain Large Diameter Carbon and Alloy Seamless Standard, Line and Pressure Pipe from This notice also serves as the only dumping and material injury to an Japan; Certain Small Diameter Carbon and Alloy reminder to parties subject to industry in the United States, the Seamless Standard, Line and Pressure Pipe from administrative protective order (APO) of Department is publishing a notice of Japan and Romania: Final Results of the Expedited continuation of the antidumping duty Third Five-Year Sunset Reviews of the Antidumping their responsibility concerning the Duty Orders, 81 FR 93648 (December 21, 2016). orders. 5 See Carbon and Alloy Seamless Standard, Line, 2 See Letter from Zekelman Industries, regarding FOR FURTHER INFORMATION CONTACT: and Pressure Pipe from Japan and Romania; ‘‘Circular Welded Carbon Quality Steel Pipe from Determinations, 82 FR 48113 (October 16, 2017) the People’s Republic of China: Withdrawal of Thomas Schauer, AD/CVD Operations, and USITC Publication 4731 (October 2017), titled Request for Administrative Review,’’ dated Office I, Enforcement and Compliance, Carbon and Alloy Seamless Standard, Line, and September 29, 2017. International Trade Administration, Continued
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Scope of the Orders purposes. The written product (CVD) investigation of certain description remains dispositive.7 crystalline silicon photovoltaic products Large Diameter Pipe From Japan (solar products) from the People’s Continuation of the Orders The products covered by this order Republic of China (PRC). The are large diameter seamless carbon and As a result of these determinations by Department is notifying the public that alloy (other than stainless) steel the Department and the USITC that the CIT’s final judgment in this case is standard, line, and pressure pipes. The revocation of the antidumping duty not in harmony with the Department’s seamless pipes subject to this order are orders would be likely to lead to final determination, as amended, in the currently classifiable under the continuation or recurrence of dumping CVD investigation of solar products subheadings 7304.10.10.30, and material injury to an industry in the from the PRC. 7304.10.10.45, 7304.10.10.60, United States, pursuant to section DATES: Applicable September 18, 2017. 751(d)(2) of the Act, the Department 7304.10.50.50, 7304.19.10.30, FOR FURTHER INFORMATION CONTACT: 7304.19.10.45, 7304.19.10.60, hereby orders the continuation of the Gene H. Calvert, AD/CVD Operations, 7304.19.50.50, 7304.31.60.10, antidumping orders on large diameter Office VII, Enforcement and 7304.31.60.50, 7304.39.00.04, pipe from Japan and small diameter Compliance, International Trade 7304.39.00.06, 7304.39.00.08, pipe from Japan and Romania. U.S. Administration, U.S. Department of 7304.39.00.36, 7304.39.00.40, Customs and Border Protection will Commerce, 1401 Constitution Avenue 7304.39.00.44, 7304.39.00.48, continue to collect antidumping duty NW., Washington, DC 20230; telephone 7304.39.00.52, 7304.39.00.56, cash deposits at the rates in effect at the (202) 482–3586. time of entry for all imports of subject 7304.39.00.62, 7304.39.00.68, SUPPLEMENTARY INFORMATION: 7304.39.00.72, 7304.51.50.15, merchandise. The effective date of the 7304.51.50.45, 7304.51.50.60, continuation of these orders will be the Background 7304.59.20.30, 7304.59.20.55, date of publication in the Federal On December 23, 2014, the 7304.59.20.60, 7304.59.20.70, Register of this notice of continuation. Department published its final 7304.59.60.00, 7304.59.80.30, Pursuant to section 751(c)(2) of the Act, determination in the CVD investigation 7304.59.80.35, 7304.59.80.40, the Department intends to initiate the of solar products from the PRC.1 On 7304.59.80.45, 7304.59.80.50, next five-year review of the orders not February 18, 2015, the Department 7304.59.80.55, 7304.59.80.60, later than 30 days prior to the fifth published an amended final 7304.59.80.65, and 7304.59.80.70 of the anniversary of the effective date of determination and CVD order.2 In the Harmonized Tariff Schedule of the continuation. Final Determination, the Department United States (HTSUS). The HTSUS These five-year (sunset) reviews and found that certain unreported assistance subheading is provided for convenience this notice are in accordance with discovered during the investigation was and customs purposes. The written section 751(c) of the Act and published countervailable using adverse facts product description remains pursuant to section 777(i)(1) of the Act. available (AFA) pursuant to section 776 dispositive.6 Dated: November 6, 2017. of the Tariff Act of 1930, as amended Gary Taverman, (the Act).3 Additionally, the Department Small Diameter Pipe From Japan and determined not to initiate investigations Romania Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations, into the mandatory respondents’ The products covered by these orders Performing the Non-exclusive Functions and creditworthinesss in certain years, include small diameter seamless carbon Duties of the Assistant Secretary for finding that SolarWorld Americas, Inc.’s and alloy (other than stainless) steel Enforcement and Compliance. (SolarWorld) creditworthiness standard, line, and pressure pipes and [FR Doc. 2017–24515 Filed 11–9–17; 8:45 am] allegation failed to satisfy the threshold redraw hollows. The seamless pipes BILLING CODE 3510–DS–P initiation requirements of 19 CFR subject to these orders are currently 351.505(a)(6)(i).4 In the Amended Final classifiable under the subheadings Determination, the Department found 7304.10.10.20, 7304.10.50.20, DEPARTMENT OF COMMERCE that it made a ministerial error in 7304.19.10.20, 7304.19.50.20, International Trade Administration countervailing one of the unreported 7304.31.30.00, 7304.31.60.50, programs, and removed that program 7304.39.00.16, 7304.39.00.20, [C–570–011] from the net countervailable subsidy 7304.39.00.24, 7304.39.00.28, rate calculated for Changzhou Trina 7304.39.00.32, 7304.51.50.05, Certain Crystalline Silicon Photovoltaic Solar Energy Co., Ltd. (Trina Solar).5 7304.51.50.60, 7304.59.60.00, Products From the People’s Republic Trina Solar and SolarWorld appealed 7304.59.80.10, 7304.59.80.15, of China: Notice of Court Decision Not the Amended Final Determination to the 7304.59.80.20, and 7304.59.80.25 of the in Harmony With Amended Final CIT, and on December 30, 2016, the CIT HTSUS. The HTSUS subheading is Affirmative Countervailing Duty provided for convenience and customs Determination 1 See Countervailing Duty Investigation of Certain Crystalline Silicon Photovoltaic Products from the AGENCY: Enforcement and Compliance, Pressure Pipe from Japan and Romania, People’s Republic of China: Final Affirmative Investigation Nos. 731–TA–847 and 849 (Third International Trade Administration, Countervailing Duty Determination, 79 FR 76962 Review). Department of Commerce. (December 23, 2014) (Final Determination). 2 6 A full description of the scope of the order is SUMMARY: On September 8, 2017, the See Certain Crystalline Silicon Photovoltaic Products from the People’s Republic of China: contained in the Memorandum, ‘‘Issues and United States Court of International Decision Memorandum for the Final Results of the Antidumping Duty Order; and Amended Final Expedited Third Sunset Reviews of the Trade (CIT) entered final judgment Affirmative Countervailing Duty Determination and Antidumping Duty Orders on Certain Large sustaining the Department of Countervailing Duty Order, 80 FR 8592 (February Diameter Carbon and Alloy Seamless Standard, Commerce’s (the Department’s) final 18, 2015) (Amended Final Determination). 3 Line and Pressure Pipe from Japan (A–588–850), results of remand redetermination See Final Determination, and accompanying Certain Small Diameter Carbon and Alloy Seamless Issues and Decision Memorandum at Comment 15. Standard, Line and Pressure Pipe from Japan (A– pertaining to the countervailing duty 4 Id. at Comment 17. 588–851) and Romania (A–485–805),’’ dated 5 See Amended Final Determination, 80 FR at December 15, 2016. 7 Id. 8593.
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sustained, in part, and remanded, in Court of Appeals for the Federal Circuit Dated: November 6, 2017. part, the Amended Final held that, pursuant to section 516A(e) of Gary Taverman, Determination.6 First, the CIT remanded the Act, the Department must publish a Deputy Assistant Secretary for Antidumping the Amended Final Determination for notice of a court decision that is not ‘‘in and Countervailing Duty Operations, the Department to make the necessary harmony’’ with a Department Performing the Non-exclusive Functions and factual findings to support its determination and must suspend Duties of the Assistant Secretary for Enforcement and Compliance. determinations, based upon AFA, to liquidation of entries pending a countervail the unreported government ‘‘conclusive’’ court decision. The CIT’s [FR Doc. 2017–24516 Filed 11–9–17; 8:45 am] subsidies discovered during the September 8, 2017, judgment sustaining BILLING CODE 3510–DS–P investigation.7 The CIT further held that the Final Remand Results constitutes a should the Department continue to find final decision of the CIT that is not in those government subsidies DEPARTMENT OF COMMERCE countervailable on remand, the harmony with the Department’s Department must then explain how it Amended Final Determination. This International Trade Administration selected the AFA rates for those notice is published in fulfillment of the 8 publication requirement of Timken. United States Travel and Tourism subsidies. Second, the CIT granted the Advisory Board: Meeting of the United Department’s request for a voluntary Amended Final Determination States Travel and Tourism Advisory remand to reconsider its determination Board not to initiate creditworthiness As there is now a final court decision investigations for Trina Solar and the with respect to the Amended Final AGENCY: International Trade other mandatory company respondent, Determination, the Department amends Administration, U.S. Department of Wuxi Suntech Power Co., Ltd. its Amended Final Determination. The Commerce. (Suntech). Department finds that the revised net ACTION: Notice of an open meeting. In accordance with the CIT’s remand countervailable subsidy rates exist: order, the Department reconsidered SUMMARY: The United States Travel and these issues and submitted its Final Subsidy Tourism Advisory Board (Board or Remand Results with the CIT on April TTAB) will hold an open meeting via Company rate (ad 28, 2017.9 In the Final Remand Results, valorem) teleconference on Wednesday, the Department continued to (%) November 29, 2017. The Board advises countervail all but one of the unreported the Secretary of Commerce on matters programs using AFA. The Department Changzhou Trina Solar Energy relating to the U.S. travel and tourism Co., Ltd ...... 33.50 also revised its determination regarding industry. The purpose of the meeting is Wuxi Suntech Power Co., Ltd .... 27.65 whether to initiate creditworthiness for Board members to consider All Others ...... 33.58 investigations for Trina Solar and recommendations being developed by Suntech, in part, and ultimately found the Hurricane Recovery subcommittee Trina Solar and Suntech to be Cash Deposit Requirements on how to accelerate recovery in uncreditworthy in certain years. As a Because there has been a subsequent destinations affected by the recent result of these changes, on remand, the administrative review for Trina Solar, hurricanes. The final agenda will be Department determined revised the cash deposit rate for Trina Solar will posted on the Department of Commerce countervailable subsidy rates of 39.50 Web site for the Board at http:// remain the rate established in the final percent for Trina Solar, 27.65 percent trade.gov/ttab at least one week in results of the administrative review of for Suntech, and 33.58 percent for all advance of the meeting. solar products from the PRC covering other producers/exporters of solar DATES: Wednesday, November 29, 2017, the period June 10, 2014, through products from the PRC.10 On September 4:00 p.m.–5:00 p.m. EST. The deadline December 31, 2015, which is 13.93 8, 2017, the CIT sustained the for members of the public to register, percent.14 As there have been no Department’s Final Remand Results in including requests to make comments full.11 subsequent administrative reviews for during the meeting and for auxiliary Suntech, the Department will instruct Timken Notice aids, or to submit written comments for U.S. Customs and Border Protection dissemination prior to the meeting, is 12 In its decision in Timken, as (CBP) to set the cash deposit rate for 5:00 p.m. EST on Wednesday, 13 clarified in Diamond Sawblades, the Suntech as listed above. November 22, 2017. Finally, the Department will instruct ADDRESSES: The meeting will be held 6 See Changzhou Trina Solar Energy Co., Ltd. et al. v. United States, Consol. Court No. 15–00068; CBP that the all-others cash deposit rate via conference call. The call-in number Slip Op. 16–121 (CIT December 30, 2016) (Remand is to be amended to reflect the simple and passcode will be provided by email Opinion and Order). average of the revised subsidy rates to registrants. Requests to register 7 Id. at 24–25. calculated for Trina Solar and for (including to speak or for auxiliary aids) 8 Id. at 26–28. 9 Suntech, as listed above. and any written comments should be See Final Results of Redetermination Pursuant submitted to: National Travel and to Court Remand, Changzhou Trina Solar Energy This notice is issued and published in Tourism Office, U.S. Department of Co., Ltd. et al. v. United States, Consol. Court No. accordance with sections 516(e), 15–00068; Slip Op. 161–121 (April 28, 2017) (Final Commerce, 1401 Constitution Ave. NW., 705(c)(1)(B), and 777(i)(1) of the Act. Remand Results). Room 10003, Washington, DC 20230 or 10 See Final Remand Results at 48. by email to [email protected]. Members 11 See Changzhou Trina Solar Energy Co., Ltd. et al., v. United States, Consol. Court No. 15–00068; of the public are encouraged to submit Slip Op. 17–122 (CIT September 8, 2017). 14 See Certain Crystalline Silicon Photovoltaic registration requests and written 12 See Timken Co. v. United States, 893 F.2d 337, Products from the People’s Republic of China: Final comments via email to ensure timely 341 (Fed. Cir. 1990) (Timken). Results of Countervailing Duty Administrative receipt. 13 See Diamond Sawblades Mfrs. Coalition v. Review, and Partial Rescission of Countervailing United States, 626 F.3d. 1374 (Fed. Cir. 2010) Duty Administrative Review; 2014–2015, 82 FR FOR FURTHER INFORMATION CONTACT: Diamond Sawblades. 42792 (September 12, 2017). Brian Beall, the United States Travel
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and Tourism Advisory Board, National DEPARTMENT OF COMMERCE Stevens Act, provided the public has Travel and Tourism Office, U.S. been notified of the Council’s intent to Department of Commerce, 1401 National Oceanic and Atmospheric take final action to address the Constitution Ave. NW., Room 10003, Administration emergency. The public also should be Washington, DC 20230; telephone: 202– RIN 0648–XF822 aware that the meeting will be recorded. 482–5634; email: [email protected]. Consistent with 16 U.S.C. 1852, a copy SUPPLEMENTARY INFORMATION: New England Fishery Management of the recording is available upon Background: The Board advises the Council; Public Meeting request. Secretary of Commerce on matters AGENCY: National Marine Fisheries Special Accommodations relating to the U.S. travel and tourism Service (NMFS), National Oceanic and This meeting is physically accessible industry. Atmospheric Administration (NOAA), to people with disabilities. Requests for Public Participation: The meeting will Commerce. sign language interpretation or other be open to the public and will be ACTION: Notice of public meeting via auxiliary aids should be directed to accessible to people with disabilities. webinar. Thomas A. Nies, Executive Director, at Any member of the public requesting to (978) 465–0492, at least 5 days prior to join the meeting is asked to register in SUMMARY: The New England Fishery the meeting date. advance by the deadline identified Management Council’s Scientific and under the DATES caption. Requests for Statistical Committee will hold a Authority: 16 U.S.C. 1801 et seq. auxiliary aids must be submitted by the webinar to reconsider its Dated: November 7, 2017. registration deadline. Last minute recommendations for setting an Tracey L. Thompson, requests will be accepted, but may not overfishing limit and acceptable Acting Deputy Director, Office of Sustainable be possible to grant. There will be biological catch for Southern New Fisheries, National Marine Fisheries Service. fifteen (15) minutes allotted for oral England/Mid-Atlantic yellowtail [FR Doc. 2017–24505 Filed 11–9–17; 8:45 am] comments from members of the public flounder and possibly for each of several BILLING CODE 3510–22–P joining the meeting. To accommodate as other flounder stocks using an empirical many speakers as possible, the time for stock assessment approach. public speaking time may be limited to Recommendations from this group will DEPARTMENT OF COMMERCE three (3) minutes per person. Members be brought to the full Council for formal of the public wishing to reserve consideration and action, if appropriate. National Oceanic and Atmospheric Administration speaking time during the meeting must DATES: This webinar will be held on submit a request at the time of Monday, November 27, 2017 beginning RIN 0648–XF828 registration, as well as the name and at 9:30 a.m. Webinar registration URL address of the proposed speaker. If the information: https://attendee.goto Fisheries of the South Atlantic; South number of registrants requesting webinar.com/register/ Atlantic Fishery Management Council; speaking time is greater than can be 7349973934358582785; Call in Public Meetings reasonably accommodated during the information: +1 (415) 930–5321, AGENCY: National Marine Fisheries meeting, the International Trade Attendee Access Code: 179–198–666. Administration may conduct a lottery to Service (NMFS), National Oceanic and ADDRESSES: Council address: New determine the speakers. Speakers are Atmospheric Administration (NOAA), England Fishery Management Council, requested to submit a written copy of Commerce. 50 Water Street, Mill 2, Newburyport, their prepared remarks by 5:00 p.m. EST ACTION: Announcement of rescheduled MA 01950. on Wednesday, November 22, 2017, for meeting and an additional meeting of inclusion in the meeting records and for FOR FURTHER INFORMATION CONTACT: the South Atlantic Fishery Management circulation to the members of the Board. Thomas A. Nies, Executive Director, Council’s Citizen Science Advisory In addition, any member of the public New England Fishery Management Panel Finance and Infrastructure Action may submit pertinent written comments Council; telephone: (978) 465–0492. Team. concerning the Board’s affairs at any SUPPLEMENTARY INFORMATION: SUMMARY: The South Atlantic Fishery time before or after the meeting. Agenda Management Council (Council) will Comments may be submitted to Brian The Scientific and Statistical hold a meeting of its Citizen Science Beall at the contact information Advisory Panel Finance and indicated above. To be considered Committee will consider an alternative to the method it used at its October 23– Infrastructure Action Team via webinar. during the meeting, comments must be The meeting via webinar was originally received no later than 5:00 p.m. EDT on 24, 2017 meeting for calculating acceptable biological catch for Southern scheduled for November 9, 2017 but has Wednesday, November 22, 2017, to been rescheduled as a result of schedule ensure transmission to the Board prior New England/Mid-Atlantic yellowtail changes (See SUPPLEMENTARY to the meeting. Comments received after flounder for fishing years 2018–20. INFORMATION). In December 2017, the that date and time will be distributed to Other business will be discussed as needed. Council will also hold another meeting the members but may not be considered of the Citizen Science Advisory Panel during the meeting. Copies of Board Although non-emergency issues not contained on the agenda may come Finance and Infrastructure Action Team meeting minutes will be available via webinar. within 90 days of the meeting. before this Council for discussion, those issues may not be the subject of formal DATES: The meeting via webinar has Dated: October 31, 2017. action during this meeting. Council been rescheduled for November 29, Brian Beall, action will be restricted to those issues 2017 at 1 p.m. The additional Action Designated Federal Officer, United States specifically listed in this notice and any Team webinar for December 2017 is Travel and Tourism Advisory Board. issues arising after publication of this scheduled for December 13, 2017 at 1 [FR Doc. 2017–24488 Filed 11–9–17; 8:45 am] notice that require emergency action p.m. Both meetings are scheduled to last BILLING CODE 3510–DR–P under section 305(c) of the Magnuson- approximately 90 minutes each.
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Additional Action Team meetings and directed to the council office (see modification and prioritization. Under plenary webinar dates and times will ADDRESSES) 3 days prior to the meeting. this generic clearance, individual offices publish in a subsequent issue in the Note: The times and sequence specified in would use approved questionnaires and Federal Register. this agenda are subject to change. develop new questionnaires, as needed, ADDRESSES: by selecting subsets of the approved set Meeting address: The meetings will be Authority: 16 U.S.C. 1801 et seq. of collection questions and tailoring held via webinar and are open to Dated: November 7, 2017. those specific questions to be members of the public. Webinar Tracey L. Thompson, meaningful for their particular registration is required and registration Acting Deputy Director, Office of Sustainable programs. These proposed links will be posted to the Citizen Fisheries, National Marine Fisheries Service. questionnaires would then be submitted Science program page of the Council’s [FR Doc. 2017–24507 Filed 11–9–17; 8:45 am] to OMB using a fast-track request for Web site at www.safmc.net. BILLING CODE 3510–22–P approval process, for which separate Council address: South Atlantic Federal Register notices are not Fishery Management Council, 4055 required. Surveys currently being Faber Place Drive, Suite 201, N. DEPARTMENT OF COMMERCE conducted include Web site satisfaction Charleston, SC 29405. surveys, Weather Service product National Oceanic and Atmospheric surveys and National Marine Sanctuary FOR FURTHER INFORMATION CONTACT: Administration participation surveys. Amber Von Harten, Citizen Science The generic clearance will not be used Program Manager, SAFMC; phone (843) Proposed Information Collection; to survey any bodies NOAA regulates 302–8433 or toll free (866) SAFMC–10; Comment Request; NOAA Customer unless precautions are taken to ensure fax: (843) 769–4520; email: Surveys that the respondents believe that they [email protected]. AGENCY: National Oceanic and are not under any risk for not SUPPLEMENTARY INFORMATION: Due to Atmospheric Administration (NOAA), responding or for the contents of their schedule changes, the scheduled Commerce. responses; e.g., in no survey to such a meeting of the Council’s Citizen Science population will the names and ACTION: Notice. Finance and Infrastructure Action Team addresses of respondents be required. originally scheduled for Thursday, SUMMARY: The Department of II. Method of Collection November 9, 2017 at 2 p.m. is Commerce, as part of its continuing rescheduled for Wednesday, November effort to reduce paperwork and Information will be collected via mail, 29, 2017 at 1 p.m. The original notice respondent burden, invites the general email or online. for that meeting published in the public and other Federal agencies to III. Data Federal Register on October 16, 2017 take this opportunity to comment on (82 FR 48063). The Council will also proposed and/or continuing information OMB Control Number: 0648–0342. hold another meeting of the Council’s collections, as required by the Form Number(s): None. Type of Review: Regular submission Citizen Science Finance and Paperwork Reduction Act of 1995. (extension of a currently approved Infrastructure Action Team on DATES: Written comments must be information collection). Wednesday, December 13, 2017 at 1 submitted on or before January 12, 2018. p.m. Affected Public: Individuals or ADDRESSES: Direct all written comments households; not-for-profit institutions; The Council created a Citizen Science to Jennifer Jessup, Departmental Advisory Panel Pool in June 2017. The state, local or tribal government; Paperwork Clearance Officer, business or other for-profit Council appointed members of the Department of Commerce, Room 6616, Citizen Science Advisory Panel Pool to organizations. 14th and Constitution Avenue NW., Estimated Number of Respondents: five Action Teams in the areas of Washington, DC 20230 (or via the Volunteers, Data Management, Projects/ 24,000. Internet at [email protected]). Estimated Time per Response: Topics Management, Finance and FOR FURTHER INFORMATION CONTACT: Response times averages 5–10 minutes. Infrastructure, and Communication/ Requests for additional information or Estimated Total Annual Burden Outreach/Education to develop program copies of the information collection Hours: 22,500. policies and operations for the Council’s instrument and instructions should be Estimated Total Annual Cost to Citizen Science Program. directed to Sarah Brabson, NOAA Office Public: $0 in recordkeeping/reporting The Finance and Infrastructure Action of the Chief Information Officer, (301) costs. Team will meet to continue work on 628–5751 or [email protected]. developing recommendations on IV. Request for Comments SUPPLEMENTARY INFORMATION: program policies and operations to be Comments are invited on: (a) Whether reviewed by the Council’s Citizen I. Abstract the proposed collection of information Science Committee. Public comment This request is for extension of a is necessary for the proper performance will be accepted at the beginning of the currently approved generic information of the functions of the agency, including meeting. collection. whether the information shall have Items to be addressed during these This collection follows the guidelines practical utility; (b) the accuracy of the meetings: contained in the OMB Resource Manual agency’s estimate of the burden 1. Discuss work on tasks in the Terms for Customer Surveys. In accordance (including hours and cost) of the of Reference with Executive Order 12862, the proposed collection of information; (c) 2. Other Business National Performance Review, and good ways to enhance the quality, utility, and management practices, NOAA offices clarity of the information to be Special Accommodations seek approval to continue to gather collected; and (d) ways to minimize the These meetings are physically customer feedback on services and/or burden of the collection of information accessible to people with disabilities. products, which can be used in on respondents, including through the Requests for auxiliary aids should be planning for service/product use of automated collection techniques
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or other forms of information in the Bering Sea; consequently, 4 hours each for Vessel Fuel Survey, technology. Chinook salmon are incidentally caught Vessel Master Survey; and Chinook EDR Comments submitted in response to in the nets as pollock is harvested. This Verification/Audit. this notice will be summarized and/or incidental catch is called bycatch and is Estimated Total Annual Burden included in the request for OMB also called prohibited species catch Hours: 1,168. approval of this information collection; (PSC). Estimated Total Annual Cost to they also will become a matter of public The Chinook Salmon Economic Data Public: $4,631 in recordkeeping/ record. Report (Chinook Salmon EDR) Program reporting costs. Dated: November 7, 2017. provides NMFS and the North Pacific Fishery Management Council (Council) IV. Request for Comments Sarah Brabson, with data to evaluate the effectiveness of Comments are invited on: (a) Whether NOAA PRA Clearance Officer. Chinook salmon bycatch management the proposed collection of information [FR Doc. 2017–24470 Filed 11–9–17; 8:45 am] measures for the Bering Sea pollock is necessary for the proper performance BILLING CODE 3510–12–P fishery that were implemented under of the functions of the agency, including Amendment 91 to the Fishery whether the information shall have Management Plan for Groundfish of the practical utility; (b) the accuracy of the DEPARTMENT OF COMMERCE Bering Sea and Aleutian Islands agency’s estimate of the burden National Oceanic and Atmospheric Management Area (75 FR 53026, August (including hours and cost) of the Administration 30, 2010). The EDR consists of three proposed collection of information; (c) data collections that are submitted ways to enhance the quality, utility, and Proposed Information Collection; annually by owners and operators of clarity of the information to be Comment Request; Alaska Chinook catcher vessels, catcher/processors, collected; and (d) ways to minimize the Salmon Economic Data Report (EDR) motherships, and the Western Alaska burden of the collection of information Community Development Quota on respondents, including through the AGENCY: National Oceanic and Program groups qualified to participate use of automated collection techniques Atmospheric Administration (NOAA), in the Bering Sea pollock fishery (50 or other forms of information Commerce. CFR 679.65). The Chinook Salmon EDR technology. ACTION: Notice. Program also includes a means for Comments submitted in response to NMFS to verify the data submitted in this notice will be summarized and/or SUMMARY: The Department of these three collections. included in the request for OMB Commerce, as part of its continuing NMFS and the Council use the approval of this information collection; effort to reduce paperwork and information to determine the they also will become a matter of public respondent burden, invites the general effectiveness of the Incentive Plan record. public and other Federal agencies to Agreement (IPA), the IPA incentives, the Dated: November 7, 2017. take this opportunity to comment on PSC limits, and the performance proposed and/or continuing information standard in terms of minimizing salmon Sarah Brabson, collections, as required by the bycatch in times of high and low levels NOAA PRA Clearance Officer. Paperwork Reduction Act of 1995. of salmon abundance. NMFS and the [FR Doc. 2017–24467 Filed 11–9–17; 8:45 am] DATES: Written comments must be Council also use the data to evaluate BILLING CODE 3510–22–P submitted on or before January 12, 2018. how Amendment 91 affects where, ADDRESSES: Direct all written comments when, and how pollock fishing and to Jennifer Jessup, Departmental salmon bycatch occur and to study and DEPARTMENT OF COMMERCE verify conclusions drawn by industry in Paperwork Clearance Officer, National Oceanic and Atmospheric the IPA annual reports. Department of Commerce, Room 6616, Administration 14th and Constitution Avenue NW., II. Method of Collection Washington, DC 20230 (or via the Internet at [email protected]). The Compensated Transfer Report, RIN 0648–XF826 Vessel Fuel Survey, and Vessel Master FOR FURTHER INFORMATION CONTACT: Survey are completed and submitted New England Fishery Management Requests for additional information or Council; Public Meeting copies of the information collection annually using a data reporting web instrument and instructions should be application on the Pacific States Marine AGENCY: National Marine Fisheries directed to Scott Miller, (907) 586–7228. Fisheries Commission Web site at Service (NMFS), National Oceanic and https://www.psmfc.org//chinookedr/. SUPPLEMENTARY INFORMATION: Atmospheric Administration (NOAA), Data for the Chinook EDR Verification/ Commerce. I. Abstract Audit are submitted by email, ACTION: Notice; public meeting. electronically, fax, or mail. This request is for extension of a currently approved information III. Data SUMMARY: The New England Fishery Management Council (Council) is collection. OMB Control Number: 0648–0633. scheduling a public meeting of its National Marine Fisheries Service Form Number(s): None. (NMFS) manages the Bering Sea pollock Type of Review: Regular submission Groundfish Committee to consider fishery under the American Fisheries (extension of a current information actions affecting New England fisheries Act (AFA) (16 U.S.C. 1851). AFA fishing collection). in the exclusive economic zone (EEZ). vessels harvest pollock in the Bering Sea Affected Public: Business or other for- Recommendations from this group will pollock fishery using pelagic (mid- profit organizations. be brought to the full Council for formal water) trawl gear, which consists of Estimated Number of Respondents: consideration and action, if appropriate. large nets towed through the water by 133. DATES: This meeting will be held on the vessel. At times, Chinook salmon Estimated Time per Response: 40 Wednesday, November 29, 2017 at 9 and pollock occur in the same locations hours for Compensated Transfer Report; a.m.
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ADDRESSES: The meeting will be held at (978) 465–0492, at least 5 days prior to incidental catch and set-asides for the the Courtyard Marriott Boston Logan the meeting date. This meeting will be observer and research programs for Airport, 225 McClellan Highway, recorded. Consistent with 16 U.S.C. fishing year 2018 and default Boston, MA; phone: (617) 569–5250. 1852, a copy of the recording is specifications for fishing year 2019. Council address: New England available upon request. Make final recommendations for Fishery Management Council, 50 Water Authority: 16 U.S.C. 1801 et seq. potential FW 29 specifications that Street, Mill 2, Newburyport, MA 01950. Dated: November 7, 2017. includes areas that may open through FOR FURTHER INFORMATION CONTACT: Tracey L. Thompson, Omnibus Habitat Amendment 2 Thomas A. Nies, Executive Director, (OHA2). The Advisory Panel will also New England Fishery Management Acting Deputy Director, Office of Sustainable Fisheries, National Marine Fisheries Service. review FW 29 management measures Council; telephone: (978) 465–0492. [FR Doc. 2017–24506 Filed 11–9–17; 8:45 am] and make final recommendations. These SUPPLEMENTARY INFORMATION: measures may include, but are not BILLING CODE 3510–22–P Agenda limited to: (1) NGOM management measures; (2) Flatfish accountability The Committee will review DEPARTMENT OF COMMERCE measures for Northern windowpane Framework Adjustment 57/ flounder, Georges Bank yellowtail Specifications and Management National Oceanic and Atmospheric flounder, and Southern New England Measures, review the draft alternatives Administration yellowtail flounder; (3) Measures to under consideration, the Groundfish modify and/or create access area and Plan Development Team’s (PDT) impact RIN 0648–XF818 open area boundaries, consistent with analysis, and make recommendations on New England Fishery Management potential changes to habitat and preferred alternatives to the Council. Council; Public Meeting groundfish closed areas; (4) measures to They will also discuss Amendment 23/ allocate unused CAI carryover pounds Groundfish Monitoring and review an AGENCY: National Marine Fisheries updated draft outline prepared by the Service (NMFS), National Oceanic and under certain scenarios of OHA2 PDT of the likely range of alternatives Atmospheric Administration (NOAA), approval. Other business may be and make recommendations to the Commerce. discussed as necessary. Council. The committee will also hold ACTION: Notice; public meeting. Although non-emergency issues not a discussion of possible groundfish contained in this agenda may come priorities for 2018 and make SUMMARY: The New England Fishery before this group for discussion, those recommendations to the Council. They Management Council (Council) is issues may not be the subject of formal also plan to discuss several recent scheduling a public meeting of its action during these meetings. Action Executive Orders that have been issued Scallop Advisory Panel to consider will be restricted to those issues about streamlining current regulations, actions affecting New England fisheries specifically listed in this notice and any and NOAA is seeking public input on in the exclusive economic zone (EEZ). issues arising after publication of this the efficiency and effectiveness of Recommendations from this group will notice that require emergency action current regulations and whether they be brought to the full Council for formal under section 305(c) of the Magnuson- can be improved. Discuss whether there consideration and action, if appropriate. Stevens Act, provided the public has are any regulations in the Northeast DATES: This meeting will be held on been notified of the Council’s intent to Multispecies fishery management plan Wednesday, November 29, 2017 at 9 take final action to address the that could be eliminated, improved, or a.m. streamlined. The committee will also emergency. ADDRESSES: The meeting will be held at review Groundfish Advisory Panel and Special Accommodations Recreational Advisory Panel the Hilton Garden Inn Logan Airport, recommendations and make 100 Boardman Street, Boston, MA This meeting is physically accessible recommendations to the council. Other 02128; phone: (617) 567–6789. to people with disabilities. Requests for business will be discussed as necessary. Council address: New England sign language interpretation or other Although non-emergency issues not Fishery Management Council, 50 Water auxiliary aids should be directed to contained in this agenda may come Street, Mill 2, Newburyport, MA 01950. Thomas A. Nies, Executive Director, at before this group for discussion, those FOR FURTHER INFORMATION CONTACT: (978) 465–0492, at least 5 days prior to issues may not be the subject of formal Thomas A. Nies, Executive Director, the meeting date. Consistent with 16 action during these meetings. Action New England Fishery Management U.S.C. 1852, a copy of the recording is will be restricted to those issues Council; telephone: (978) 465–0492. available upon request. specifically listed in this notice and any SUPPLEMENTARY INFORMATION: issues arising after publication of this Authority: 16 U.S.C. 1801 et seq. Agenda notice that require emergency action Dated: November 7, 2017. under section 305(c) of the Magnuson- The Scallop Advisory Panel will Tracey L. Thompson, Stevens Act, provided the public has review Framework 29 (FW 29) Acting Deputy Director, Office of Sustainable been notified of the Council’s intent to alternatives and analyses, and make Fisheries, National Marine Fisheries Service. final recommendations. FW 29 will set take final action to address the [FR Doc. 2017–24504 Filed 11–9–17; 8:45 am] emergency. specifications including acceptable biological catch/annual catch limit BILLING CODE 3510–22–P Special Accommodations (ABC/ACLs), Days at Sea (DAS), access This meeting is physically accessible area allocations for Limited Access (LA) to people with disabilities. Requests for and Limited Access General Category sign language interpretation or other (LAGC), Total Allowable Catch (TAC) auxiliary aids should be directed to for Northern Gulf of Maine (NGOM) Thomas A. Nies, Executive Director, at management area, target-TAC for LAGC
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DEPARTMENT OF COMMERCE Dated: November 7, 2017. Flatfish Bycatch Reduction in the Sarah Brabson, Limited Access (LA) Scallop Fishery.’’ National Oceanic and Atmospheric NOAA PRA Clearance Officer. The project would test a modified Administration [FR Doc. 2017–24471 Filed 11–9–17; 8:45 am] flounder cookie sweep on the outer bale BILLING CODE 3510–22–P bars of the scallop dredge and film fish- Submission for OMB Review; dredge interactions to monitor the Comment Request effectiveness of the gear modification in The Department of Commerce will DEPARTMENT OF COMMERCE reducing flatfish bycatch. submit to the Office of Management and To conduct this experiment, vessels Budget (OMB) for clearance the National Oceanic and Atmospheric would require exemptions from the following proposal for collection of Administration following regulations: Atlantic sea scallop crew size restrictions at 50 CFR information under the provisions of the RIN 0648–XF829 Paperwork Reduction Act (44 U.S.C. 648.51(c); dredge gear obstruction Chapter 35). Magnuson-Stevens Act Provisions; restrictions at § 648.51(b)(4)(ii); Atlantic Agency: National Oceanic and General Provisions for Domestic sea scallop observer program Atmospheric Administration (NOAA). Fisheries; Application for Exempted requirements at § 648.11(g); and closed Title: Alaska Prohibited Species Fishing Permits area exemptions for Closed Area I at Donation Program. § 648.60(c), Closed Area II at OMB Control Number: 0648–0316. AGENCY: National Marine Fisheries § 648.60(d), Closed Area II Extension at Form Number(s): None. Service (NMFS), National Oceanic and § 648.60(e), and Nantucket Lightship at Type of Request: Regular (extension of Atmospheric Administration (NOAA), § 648.60(f). It would also exempt a currently approved information Commerce. participating vessels from possession collection). ACTION: Notice; request for comments. limits and minimum fish size Number of Respondents: 1. requirements specified in 50 CFR part Average Hours per Response: 50 SUMMARY: The Assistant Regional 648, subsections B and D through O, for hours for a three-year permit, Administrator for Sustainable Fisheries, biological sampling purposes only. annualized to 17. Greater Atlantic Region, NMFS, has Vessels would conduct scallop Burden Hours: 17. made a preliminary determination that dredging between November 2017-June Needs and Uses: The prohibited an Exempted Fishing Permit application 2018, on 2 trips each lasting species donation (PSD) program for contains all of the required information approximately 7 days-at-sea (DAS) each salmon and halibut has effectively and warrants further consideration. This for a project total of 14 DAS. An average reduced regulatory discard of salmon Exempted Fishing Permit would exempt of 10 tows per day would be conducted and halibut by allowing fish that would a commercial fishing vessel from for a maximum duration of 50 minutes otherwise be discarded to be donated to Atlantic sea scallop regulations in at a tow speed range of 4.8–5.1 knots needy individuals through tax-exempt support of research conducted by the (2.5–2.6 m/s). Trips would take place in organizations. Vessels and processing Coonamessett Farm Foundation. scallop open areas of Southern New plants participating in the PSD program Regulations under the Magnuson- England and Georges Bank along with voluntarily retain and process salmon Stevens Fishery Conservation and scallop access areas Nantucket and halibut bycatch. An authorized, tax- Management Act require publication of Lightship and Closed Areas I and II. exempt distributor, chosen by the this notification to provide interested The vessel would conduct all tows National Marine Fisheries Service parties the opportunity to comment on with two 15-foot (4.57-m) New Bedford (NMFS), is responsible for monitoring applications for proposed Exempted Style dredges, one acting as a control retention and processing of fish donated Fishing Permits. dredge and one acting as an by vessels and processors. The DATES: Comments must be received on experimental dredge. The vessel would authorized distributor also coordinates or before November 28, 2017. tow both dredges simultaneously to reduce spatial and temporal variability. processing, storage, transportation, and ADDRESSES: You may submit written distribution of salmon and halibut. The Researchers would attach the two 9-foot comments by any of the following (2.74-m) cookie sweeps to each of the PSD program requires an information methods: collection so that NMFS can monitor the • outer bale bars using chain and shackles Email: [email protected]. on the experimental dredge. The cookie authorized distributors’ ability to Include in the subject line ‘‘DA17–100 effectively supervise program sweeps would alternate between the two CFF BREP LA Flounder Sweep Study dredges each tow to reduce ‘‘side’’ participants and ensure that donated EFP.’’ fish are properly processed, stored, and • effects. The cookie sweeps would be Mail: John K. Bullard, Regional constructed of round rubber disks with distributed. Administrator, NMFS, Greater Atlantic Affected Public: Not-for-profit lead cookies approximately 3–4 inches Regional Fisheries Office, 55 Great (7.6–10.2 cm) in diameter evenly spaced institution. Republic Drive, Gloucester, MA 01930. Frequency: Every three years. to encourage bottom contact. The Mark the outside of the envelope Respondent’s Obligation: Mandatory. attachment chains would be evenly This information collection request ‘‘Comments on DA17–100 CFF BREP LA spaced and varied in length to account may be viewed at reginfo.gov. Follow Flounder Sweep Study EFP.’’ for dredge position while being towed to the instructions to view Department of FOR FURTHER INFORMATION CONTACT: ensure contact with the ocean bottom. Commerce collections currently under Shannah Jaburek, Fisheries Management Exemption from the dredge gear review by OMB. Specialist, 978–282–8456. obstruction regulation would allow Written comments and SUPPLEMENTARY INFORMATION: researchers to use the cookie sweep for recommendations for the proposed Coonamessett Farm Foundation (CFF) the experimental tows. information collection should be sent submitted an application for an EFP on Researchers would weigh all scallop within 30 days of publication of this September 18, 2017, for a 2017 Bycatch catch in industry bushel baskets caught notice to OIRA_Submission@ Reduction Engineering Program project in both dredges and measure a one- omb.eop.gov or fax to (202) 395–5806. titled ‘‘A Modified Flounder Sweep for basket sub-sample from each side in 5-
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millimeter increments. The researchers returned to the sea as soon as Researchers would discard all catch would also obtain total weight of practicable following data collection. above a possession limit or below a bycatch species and individual Exemption from possession limit and minimum size as soon as practicable measurements to the nearest centimeter. minimum sizes would support catch following data collection. The table If the volume of the catch is large, sampling activities, and ensure the below lists the anticipated catch for the subsampling protocols would be vessel is not in conflict with possession project. No catch would be landed for necessary. All bycatch would be regulations while collecting catch data. sale.
Weight Weight Species (lb) (kg)
Scallop ...... 20,000 9,072 Northeast Skate Complex (Barndoor Skate not included) ...... 50,000 22,680 Barndoor Skate ...... 250 113 Summer Flounder ...... 90 41 Winter Flounder ...... 250 113 Yellowtail Flounder ...... 750 340 Windowpane Flounder ...... 750 340 Monkfish ...... 1,750 794
Researchers need additional Atmospheric Administration (NOAA), potential datasets and recommends exemptions to deploy dredge gear in Commerce. which datasets are appropriate for closed areas in order to help locate large ACTION: Notice of SEDAR 55 Assessment assessment analyses, and describes the enough aggregations of flatfish to test Scoping webinar II. fisheries, evaluates the status of the the experimental gear. Participating stock, estimates biological benchmarks, vessels need crew size waivers to SUMMARY: The SEDAR 55 assessment of projects future population conditions, accommodate science personnel and the South Atlantic stock of Vermilion and recommends research and possession waivers would enable them Snapper will consist of a series of monitoring needs. Participants for to conduct data collection activities. We webinars. See SUPPLEMENTARY SEDAR Workshops are appointed by the would waive the observer program INFORMATION. Gulf of Mexico, South Atlantic, and notification requirements because the DATES: A SEDAR 55 Assessment Caribbean Fishery Management research activity is not representative of Scoping webinar II will be held on Councils and NOAA Fisheries Southeast standard fishing activity. Tuesday, November 28, 2017, from 9 Regional Office, Highly Migratory If approved, the applicant may a.m. until 1 p.m. Species Management Division, and request minor modifications and ADDRESSES: Southeast Fisheries Science Center. extensions to the EFP throughout the Meeting address: The meetings will be Participants include: Data collectors and year. EFP modifications and extensions held via webinar. The webinars are database managers; stock assessment may be granted without further notice if open to members of the public. Those scientists, biologists, and researchers; they are deemed essential to facilitate interested in participating should constituency representatives including completion of the proposed research contact Julia Byrd at SEDAR (see FOR fishermen, environmentalists, and non- and have minimal impacts that do not FURTHER INFORMATION CONTACT) to governmental organizations (NGOs); change the scope or impact of the request an invitation providing webinar international experts; and staff of initially approved EFP request. Any access information. Please request Councils, Commissions, and state and fishing activity conducted outside the webinar invitations at least 24 hours in federal agencies. scope of the exempted fishing activity advance of each webinar. The items of discussion in the would be prohibited. SEDAR address: South Atlantic Assessment Scoping webinar II are as Fishery Management Council, 4055 follows: Authority: 16 U.S.C. 1801 et seq. Faber Place Drive, Suite 201, N. Participants will review data and Dated: November 7, 2017. Charleston, SC 29405; discuss data issues, as necessary, and Emily H. Menashes, www.sedarweb.org. initial model issues. Acting Director, Office of Sustainable Although non-emergency issues not FOR FURTHER INFORMATION CONTACT: Julia contained in this agenda may come Fisheries, National Marine Fisheries Service. Byrd, SEDAR Coordinator, 4055 Faber [FR Doc. 2017–24520 Filed 11–9–17; 8:45 am] before this group for discussion, those Place Drive, Suite 201, North issues may not be the subject of formal BILLING CODE 3510–22–P Charleston, SC 29405; phone: (843) 571– action during this meeting. Action will 4366; email: [email protected]. be restricted to those issues specifically SUPPLEMENTARY INFORMATION: The Gulf DEPARTMENT OF COMMERCE identified in this notice and any issues of Mexico, South Atlantic, and arising after publication of this notice National Oceanic and Atmospheric Caribbean Fishery Management that require emergency action under Administration Councils, in conjunction with NOAA section 305(c) of the Magnuson-Stevens Fisheries and the Atlantic and Gulf Fishery Conservation and Management States Marine Fisheries Commissions, RIN 0648–XF816 Act, provided the public has been have implemented the Southeast Data, notified of the intent to take final action Fisheries of the South Atlantic; Assessment and Review (SEDAR) to address the emergency. process, a multi-step method for Southeast Data, Assessment, and Special Accommodations Review (SEDAR); Public Meeting determining the status of fish stocks in the Southeast Region. The product of This meeting is accessible to people AGENCY: National Marine Fisheries the SEDAR webinar series will be a with disabilities. Requests for auxiliary Service (NMFS), National Oceanic and report which compiles and evaluates aids should be directed to the SAFMC
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office (see ADDRESSES) at least 5 define the responsibilities for observer Estimated Total Annual Cost to business days prior to the meeting. providers, including reporting Public: $0 in capital costs as it is Note: The times and sequence specified in requirements. Regulations at § 660.140 assumed that each of the 5 observer/ this agenda are subject to change. (i) specify requirements for catch catch monitor providers will maintain a monitor coverage for first receivers. Data computer system with email capacity Authority: 16 U.S.C. 1801 et seq. collected by observers are used by for general business purposes and that Dated: November 7, 2017. NMFS to estimate total landed catch each vessel owner/operator has access Tracey L. Thompson, and discards, monitor the attainment of to a telephone for toll-free calls. annual groundfish allocations, estimate Acting Deputy Director, Office of Sustainable IV. Request for Comments Fisheries, National Marine Fisheries Service. catch rates of prohibited species, and as Comments are invited on: (a) Whether [FR Doc. 2017–24503 Filed 11–9–17; 8:45 am] a component in stock assessments. the proposed collection of information BILLING CODE 3510–22–P These data are necessary to comply with the Magnuson-Stevens Act requirements is necessary for the proper performance to prevent overfishing. In addition, of the functions of the agency, including DEPARTMENT OF COMMERCE observer data is used to assess fishing whether the information shall have related mortality of protected and practical utility; (b) the accuracy of the National Oceanic and Atmospheric endangered species. agency’s estimate of the burden Administration (including hours and cost) of the II. Method of Collection proposed collection of information; (c) Proposed Information Collection; This collection utilizes both ways to enhance the quality, utility, and Comment Request; Monitoring electronic and paper forms, depending clarity of the information to be Programs for Vessels in the Pacific on the specific item. Methods of collected; and (d) ways to minimize the Coast Groundfish Fishery submittal include email of electronic burden of the collection of information AGENCY: National Oceanic and forms, and mail and facsimile on respondents, including through the Atmospheric Administration (NOAA), transmission of paper forms. use of automated collection techniques Commerce. Additionally, this collection utilizes or other forms of information interviews for some information technology. ACTION: Notice. collection and phone calls for Comments submitted in response to SUMMARY: The Department of transmission of other information. this notice will be summarized and/or included in the request for OMB Commerce, as part of its continuing III. Data effort to reduce paperwork and approval of this information collection; respondent burden, invites the general OMB Control Number: 0648–0500. they also will become a matter of public public and other Federal agencies to Form Number(s): None. record. Type of Review: Regular (extension of take this opportunity to comment on Dated: November 7, 2017. proposed and/or continuing information a current information collection). Affected Public: Business or other for- Sarah Brabson, collections, as required by the profit organizations. NOAA PRA Clearance Officer. Paperwork Reduction Act of 1995. Estimated Number of Respondents: [FR Doc. 2017–24469 Filed 11–9–17; 8:45 am] DATES: Written comments must be 268 (5 providers (supplying a total of 75 BILLING CODE 3510–22–P submitted on or before January 12, 2018. observers or catch monitors) and 263 ADDRESSES: Direct all written comments fishing vessels). to Jennifer Jessup, Departmental Estimated Time per Response: For BUREAU OF CONSUMER FINANCIAL Paperwork Clearance Officer, providers: 15 minutes for observer PROTECTION Department of Commerce, Room 6616, training/briefing/debriefing registration, 14th and Constitution Avenue NW., notification of observer physical [Docket No. CFPB–2017–0037] Washington, DC 20230 (or via the examination, observer status reports, Request for Information Regarding Internet at [email protected]). other reports on observer harassment, Consumers’ Experience With Free FOR FURTHER INFORMATION CONTACT: safety concerns, or performance Access to Credit Scores Requests for additional information or problems, catch monitor status reports, copies of the information collection and other catch monitor reports on AGENCY: Bureau of Consumer Financial instrument and instructions should be harassment, prohibited actions, illness Protection. directed to the West Coast Regional or injury, or performance problems; 5 ACTION: Notice and request for Office—7600 Sand Point Way NE., minutes for observer safety checklist information. Seattle, WA 98115, Keeley Kent, submission to NMFS, observer provider telephone number ((206) 526–4655), or contracts, observer information SUMMARY: The Dodd-Frank Wall Street [email protected]. materials, catch monitor provider Reform and Consumer Protection Act of SUPPLEMENTARY INFORMATION: contracts, and catch monitor 2010 (Dodd-Frank) established the informational materials; 10 minutes for Office of Financial Education within the I. Abstract certificate of insurance; 7 minutes for Bureau of Consumer Financial In 2011, NMFS mandated observer catch monitor training/briefing Protection (CFPB or Bureau) to develop requirements for the West Coast registration, notification of catch and launch initiatives that will educate groundfish trawl catch shares program. monitor physical examination, and consumers and help them make better For all fishery sectors, observers must be catch monitor debriefing registration. informed financial decisions. obtained through third-party observer For vessels: 10 minutes for fishing The CFPB’s Office of Financial provider companies operating under departure reports and cease-fishing Education seeks to learn more about the permits issued by NMFS. The reports. experience consumers are having with regulations at §§ 660.140 (h), 660.150 (j), Estimated Total Annual Burden access to free credit scores and the 660.160 (g), specify observer coverage Hours: 525 (305 for providers and 220 experience of companies, and requirements for trawl vessels and for fishing vessels). nonprofits, offering their customers and
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the general public free access to their Access to Credit Scores,’’ please contact and the general public free access to credit scores. The Bureau encourages Irene Skricki, Office of Financial credit scores? comments from all interested members Education, at 202–435–7181. 2. What sources are consumers using of the public, including consumers, SUPPLEMENTARY INFORMATION: to access free credit scores? consumer advocacy groups, credit card 3. How have consumers benefitted companies and other lenders, nonprofit I. Background from having increased free regular credit and financial counseling Over the last few years, many access to one of their credit scores? Are providers, credit reporting companies, financial institutions, credit card there ways in which consumers have researchers and any other interested issuers, and other companies have been hurt from having this access? What party. offered consumers free access to a credit are examples of the ways in which score, giving consumers an important consumers have benefitted or been hurt DATES: Comments must be received on tool to manage their financial lives. from having increased free regular or before February 12, 2018 to be To raise consumer awareness of this access to one of their credit scores? assured of consideration. service, the CFPB’s Office of Financial 4. What have been the benefits and ADDRESSES: You may submit comments Education published in March 2017 a costs to companies for providing regarding the ‘‘Request for Information list of companies that told the Bureau consumers with increased free regular Regarding Consumers’ Experience with they offer existing credit card customers access to one of their credit scores? Free Access to Credit Scores,’’ identified free access to a credit score. The list was What are examples of these benefits and by title and by Docket No. CFPB–2017– compiled based on comments received costs? 0037, by any of the following methods: • in response to a public notice published 5. What has been the rate of uptake, Electronic: http:// in the Federal Register in October 2016. frequency, and duration of use of the www.regulations.gov. Follow the As a next step, through this request service that provides consumers with instructions for submitting comments. for information, the Bureau seeks to • free regular access to one of their credit Mail: Consumer Financial learn more about the experience scores? Protection Bureau (Attention: Office of consumers are having with access to 6. How is access to free credit scores Financial Education), 1700 G Street free credit scores. The Bureau also seeks and/or frequency and duration of use of NW., Washington, DC 20552. • to learn about the experience of this service related to observed changes Hand Delivery/Courier: Consumer companies and of nonprofit credit and in consumers’ credit standing or credit Financial Protection Bureau (Attention: financial counseling providers offering behavior? For example, these changes Office of Financial Education), 1700 G their customers and the general public might include positive or negative Street NW., Washington, DC 20552. free access to credit scores. trends in credit scores, or changes in Instructions: The Bureau encourages A core part of the mission of the loan payment behavior, the speed of the early submission of comments. All Bureau is educating and empowering payment of outstanding loan balances, submissions must include the document consumers to take more control over the rate of applications for new loans, or title and docket number. Because paper their financial lives. The information any other factor. mail in the Washington, DC area and at gathered through this request for 7. What are examples of the questions the Bureau is subject to delay, information will be used to identify consumers ask companies, as well as commenters are encouraged to submit educational content that is providing credit and financial counseling comments electronically. In general, all the most value to consumers, and providers, after they have seen their free comments received will be posted additional educational content that the credit scores? without change to http:// Bureau or others could develop to 8. Do consumers face challenges in www.regulations.gov. In addition, increase consumers’ understanding of accessing free credit scores? If so, what comments will be available for public credit scores and credit reports. This are examples of those challenges? inspection and copying at 1700 G Street request for information will also be used 9. What are examples of NW., Washington, DC 20552, on official to gain a broader understanding of the implementation challenges companies business days between the hours of 10 industry practices that best support have faced, continue to face, or are a.m. and 5 p.m. eastern standard time. educating and empowering consumers. likely to emerge in the future, in You can make an appointment to The Bureau encourages comments providing consumers with free regular inspect the documents by telephoning from all interested members of the access to one of their credit scores? 202–435–7275. public, including consumers, consumer 10. What are examples of solutions All submissions, including advocacy groups, credit card companies companies have identified to address attachments and other supporting and other lenders, nonprofit credit and these implementation challenges? materials, will become part of the public financial counseling providers, credit 11. What are examples of the record and subject to public disclosure. reporting companies, researchers and educational content that is provided to Do not include sensitive personal any other interested party. The Bureau consumers when they access their free information such as account numbers or is interested in all input from credit scores? With regards to this Social Security numbers. Comments commenters, including consumer educational content, what information will not be edited to remove any experiences, knowledge of the industry appears to be most effective in helping identifying or contact information, such practices that best support educating consumers understand their credit as name and address information, email and empowering consumers, scores and the factors that impact their addresses, or telephone numbers. educational content that is providing scores? FOR FURTHER INFORMATION CONTACT: For the most value to consumers, and views 12. Can consumers have free regular general inquiries, submission process on the questions included in this notice. access to one of their credit scores questions or any additional information, Please feel free to comment generally without receiving marketing for other please contact Monica Jackson, Office of and/or respond to any or all of the products and services? If marketing is the Executive Secretary, at 202–435– questions below. provided with the access to a free score, 7275. For information about the 1. How are companies, and nonprofit what are examples of the types of ‘‘Request for Information Regarding credit and financial counseling products and services being marketed? Consumers’ Experience with Free providers, offering existing customers How have consumers benefitted or
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otherwise been impacted by being Office of Financial Education within the Do not include sensitive personal offered products and services at the time Bureau of Consumer Financial information such as account numbers or when they access and see their credit Protection (CFPB or Bureau) to develop Social Security numbers. Comments scores? and launch initiatives that will educate will not be edited to remove any 13. What features related to how consumers and help them make better identifying or contact information, such regular free access to a credit score is informed financial decisions. as name and address information, email offered to consumers appear to be most The CFPB’s Office of Financial addresses, or telephone numbers. effective in helping consumers make use Education published in March 2017 a FOR FURTHER INFORMATION CONTACT: For of this service? list of companies that told us they offer general inquiries, submission process 14. The CFPB also offers a number of existing credit card customers free questions or any additional information, educational supports to help consumers access to a credit score. The Bureau is please contact Monica Jackson, Office of understand and act on their credit updating this list and will use the the Executive Secretary, at 202–435– reports and scores, including a Credit responses received to this notice to 7275. For information about the ‘‘Notice Reports & Scores information portal publish an updated list. The Bureau will of an Update to the Public List of available at consumerfinance.gov/ leverage this updated list to bring Companies That Offer Customers Free consumer-tools/credit-reports-and- consumer attention to the topic of Access to a Credit Score,’’ please contact scores/; many frequently asked consumers’ credit standing, of which Irene Skricki, Office of Financial questions in Ask CFPB on the Bureau’s their credit score is a valuable indicator. Education, at 202–435–7181. Web site; and online brochures that The Bureau will follow up the SUPPLEMENTARY INFORMATION: include Check your credit report, publication of this updated list with Understand your credit score, You have content to educate consumers about the I. Background many credit scores, Credit report review availability of credit scores and credit Over the last few years, many check list, and a list of consumer reports and how this information can be financial institutions, credit card reporting companies. Is there additional used effectively. issuers, and other companies have educational content or topics that could DATES: Comments must be received on offered consumers free access to a credit be developed by the CFPB or others to or before January 12, 2018 to be assured score, giving consumers an important support increased consumer of consideration. tool to manage their financial lives. The understanding of credit scores and ADDRESSES: You may submit comments Consumer Financial Protection Bureau credit reports—for example, educational regarding the ‘‘Notice of an Update to (‘‘the Bureau’’) would like to highlight content that focuses on increasing the Public List of Companies That Offer and build consumer awareness of this awareness of credit scores to young Customers Free Access to a Credit practice. A core part of the mission of consumers; how student debt can Score,’’ identified by title and by Docket the Bureau is educating and impact a consumer’s credit score; or a No. CFPB–2017–0034, by any of the empowering consumers to take more person’s credit standing over time, following methods: control over their financial lives. The which might be of interest to older • Electronic: http:// Bureau believes that enabling adults/seniors? www.regulations.gov. Follow the consumers to see their credit scores can 15. Has increased access to free credit instructions for submitting comments. be a first step towards consumers scores encouraged consumers that use • Mail: Consumer Financial learning about their credit history, this service to also check their credit Protection Bureau (Attention: Office of becoming aware of and encouraged to reports or take other steps to learn more Financial Education), 1700 G Street request a free copy of their credit about their credit standing? What are NW., Washington, DC 20552. reports, ensuring the accuracy and examples of the steps these consumers • Hand Delivery/Courier: Consumer completeness of their credit reports, and have taken? Financial Protection Bureau (Attention: ultimately making informed decisions Thank you for your contribution to Office of Financial Education), 1700 G about credit that serve their own improve consumer financial awareness. Street NW., Washington, DC 20552. financial and life goals. Dated: November 4, 2017. Instructions: The Bureau encourages The Bureau published in March 2017 Richard Cordray, the early submission of comments. All a list of companies that told us they Director, Bureau of Consumer Financial submissions must include the document offer existing credit card customers free Protection. title and docket number. Because paper access to a credit score. The Bureau is [FR Doc. 2017–24555 Filed 11–9–17; 8:45 am] mail in the Washington, DC area and at updating this list and will use the BILLING CODE 4810–AM–P the Bureau is subject to delay, responses received to this Notice to commenters are encouraged to submit publish an updated list. comments electronically. In general, all The Bureau will leverage this updated BUREAU OF CONSUMER FINANCIAL comments received will be posted list to bring consumer attention to the PROTECTION without change to http:// topic of consumers’ credit standing, of www.regulations.gov. In addition, which their credit score is a valuable [Docket No. CFPB–2017–0034] comments will be available for public indicator. The Bureau will follow up the Notice of an Update to the Public List inspection and copying at 1700 G Street publication of this updated list with of Companies That Offer Customers NW., Washington, DC 20552, on official content to educate consumers about the Free Access to a Credit Score business days between the hours of 10 availability of credit scores and credit a.m. and 5 p.m. eastern standard time. reports and how this information can be AGENCY: Bureau of Consumer Financial You can make an appointment to used effectively. Protection. inspect the documents by telephoning If your company was included on the ACTION: Notice. 202–435–7275. list published in March 2017 and would All submissions, including like to be included in the updated list, SUMMARY: The Dodd-Frank Wall Street attachments and other supporting your company must submit a new entry. Reform and Consumer Protection Act of materials, will become part of the public Please indicate in your comment if your 2010 (Dodd-Frank) established the record and subject to public disclosure. company would like the entry
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submitted last year to be included in the last year, if you indicate that you would use http://www.regulations.gov by new list without any changes. Or, like last year’s submission to be searching the Docket ID number ED– alternatively, please submit a new entry included again. Consumers reading the 2017–ICCD–0136. Comments submitted providing an update on how your list will be encouraged to check this in response to this notice should be company offers this service to information, or to contact each submitted electronically through the consumers. company, to find out which specific Federal eRulemaking Portal at http:// credit card or financial products are www.regulations.gov by selecting the II. Criteria To Be Included in the eligible for the service, and on what Docket ID number or via postal mail, Update to This Public List conditions, if any. commercial delivery, or hand delivery. If your company is a credit card By responding to this Federal Please note that comments submitted by issuer, fits the criteria outlined below, Register Notice (FRN) you are stating fax or email and those submitted after and would like to be included in the that you meet the criteria and are the comment period will not be updated list the Bureau plans to consenting to include the name of your accepted. Written requests for publish, contact us by following the company in a public list of credit card information or comments submitted by instructions included in this Notice for issuers, or in a possible list of postal mail or delivery should be submitting an entry.1 companies in other markets as addressed to the Director of the If your company is not a credit card applicable, offering free access to credit Information Collection Clearance issuer, but offers existing consumer scores to their existing customers. The Division, U.S. Department of Education, customers free access to a credit score, Bureau reserves the right to conduct due 400 Maryland Avenue SW., LBJ, Room fits the criteria outlined below, and diligence on a company’s assertions 216–34, Washington, DC 20202–4537. would like to be included in a possible about meeting the criteria stated in this FOR FURTHER INFORMATION CONTACT: For list for companies in other markets, you notice. Your response to this FRN and specific questions related to collection may contact us as well. Depending on inclusion in this public list are activities, please contact Beth the feedback received, the Bureau may completely voluntary, and your choice Grebeldinger, 202–377–4018. decide to expand the scope of the initial to do so, or refrain from doing so, is not SUPPLEMENTARY INFORMATION: The list of companies offering free credit connected to supervisory activity by the Department of Education (ED), in scores beyond credit card issuers to Bureau. accordance with the Paperwork companies in some other markets, We emphasize that these lists will be Reduction Act of 1995 (PRA) (44 U.S.C. include such companies in a future created to further inform the public 3506(c)(2)(A)), provides the general separate list, or decide not to publish a about where to find a credit score, and public and Federal agencies with an list of companies in other markets will not be an endorsement of the opportunity to comment on proposed, offering this service. financial institutions, credit card revised, and continuing collections of To be included in this list of credit issuers, or any other company information. This helps the Department card issuers, or in a possible list of mentioned in any document the Bureau assess the impact of its information companies in other markets, you must publishes. collection requirements and minimize meet the following criteria: Thank you for your contribution to • Offer or provide a consumer improve consumer financial awareness. the public’s reporting burden. It also helps the public understand the financial product or service; Dated: November 4, 2017. • Offer existing customers 2 (at least Department’s information collection Richard Cordray, some, but not necessarily all) the ability requirements and provide the requested to obtain free of charge a credit score 3 Director, Bureau of Consumer Financial data in the desired format. ED is Protection. that either your company or other soliciting comments on the proposed lenders use for account origination, [FR Doc. 2017–24552 Filed 11–9–17; 8:45 am] information collection request (ICR) that portfolio management, or for other BILLING CODE 4810–AM–P is described below. The Department of business purposes; Education is especially interested in • Offer this access to a credit score on public comment addressing the a continuous basis, as opposed to on a DEPARTMENT OF EDUCATION following issues: (1) Is this collection necessary to the proper functions of the time-limited or promotional basis, and [Docket No.: ED–2017–ICCD–0136] periodically update the score. Department; (2) will this information be You may include other information Agency Information Collection processed and used in a timely manner; you think is relevant for consumers Activities; Comment Request; Teacher (3) is the estimate of burden accurate; reading the public list to understand Education Assistance for College and (4) how might the Department enhance whether the service applies to them. Higher Education Grant Eligibility the quality, utility, and clarity of the The updated list will include a link to Regulations information to be collected; and (5) how the comment your company submits— might the Department minimize the AGENCY: Federal Student Aid (FSA), or a link to your company’s entry from burden of this collection on the Department of Education (ED). respondents, including through the use 1 ‘‘Credit card issuer’’ refers to any entity to ACTION: Notice. of information technology. Please note which a consumer is legally obligated, or would be that written comments received in legally obligated, under the terms of a credit card SUMMARY: In accordance with the response to this notice will be agreement. Alternatively, you can also be included Paperwork Reduction Act of 1995, ED is considered public records. in this list if you are a bank or a credit union and proposing an extension of an existing Title of Collection: Teacher Education you contract with a third party to issue credit cards information collection. on your behalf and under your brand name. Assistance for College and Higher 2 ‘‘Customers’’ refers to individuals, not DATES: Interested persons are invited to Education Grant Eligibility Regulations. corporations or small businesses. submit comments on or before January OMB Control Number: 1845–0084. 3 By ‘‘credit score’’ we refer to a score that is 12, 2018. Type of Review: An extension of an empirically derived, demonstrably and statistically ADDRESSES: sound, and based on current data from a consumer To access and review all the existing information collection. reporting agency to predict the likelihood of certain documents related to the information Respondents/Affected Public: State, credit behavior for the applicant. collection listed in this notice, please Local, and Tribal Governments;
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Individuals or Households; Private FOR FURTHER INFORMATION CONTACT: For This meeting is considered ‘‘open-to- Sector. further information regarding the public the-public;’’ the purpose for this Total Estimated Number of Annual meeting, please contact Seth Lawson or meeting has been examined during the Responses: 232,324. Walter Perry at NETL by telephone at planning stages, and NETL management Total Estimated Number of Annual (304) 285–4469, by email at has made specific determinations that Burden Hours: 36,673. [email protected], affect attendance. All information Abstract: The Teacher Education [email protected], or by postal presented at this meeting must meet Assistance for College and Higher mail addressed to National Energy criteria for public sharing or be Education (TEACH) Grant program is a Technology Laboratory, 3610 Collins published and available in the public non-need-based grant program that Ferry Road, P.O. Box 880, Morgantown, domain. Participants should not provides up to $4,000 per year to WV 26507–0880. Please direct all media communicate information that is students who are enrolled in an eligible inquiries to the NETL Public Affairs considered official use only, program and who agree to teach in a Officer at (304) 285–0228. proprietary, sensitive, restricted or high-need field, at a low-income SUPPLEMENTARY INFORMATION: protected in any way. Foreign nationals, elementary or secondary school for at who may be present, have not been Instructions and Information on the least four years within eight years of approved for access to DOE information Public Meeting completing the program for which the and technologies. The public meeting will be held via TEACH Grant was awarded. The Dated: October 20, 2017. TEACH Grant program regulations are WebEx. The public meeting will begin Heather Quedenfeld, required to ensure accountability of the at 1:00 p.m. and end at 3:00 p.m. program participants, both institutions Agenda details will be available prior to Associate Director, Coal Technology the meeting on the NETL Web site, Development & Integration Center National and student recipients, for proper Energy Technology Laboratory. program administration, to determine https://www.netl.doe.gov/events/sco2- [FR Doc. 2017–24497 Filed 11–9–17; 8:45 am] eligibility to receive program benefits tech-group. Interested parties may and to prevent fraud and abuse of RSVP, to confirm their participation and BILLING CODE 6450–01–P program funds. The regulations include receive login instructions, by emailing [email protected]. both record-keeping and reporting DEPARTMENT OF ENERGY requirements. The record-keeping by the The objective of the Supercritical CO2 Oxy-combustion Technology Group is to school allows for review of compliance Federal Energy Regulatory promote a technical understanding of with the regulation during on-site Commission institutional reviews. The Department oxy-combustion for direct-fired sCO2 uses the required reporting to allow for power cycles by sharing information or [Project No. 14795–002] close-out of institutions that are no viewpoints from individual participants longer participating or who lose regarding risk reduction and challenges Shell Energy North America (US), LP; eligibility to participate in the program. associated with developing the Notice of Application Tendered for technology. Filing With the Commission and Dated: November 7, 2017. Oxy-combustion systems in directly Soliciting Additional Study Requests Kate Mullan, heated supercritical CO2 (SCO2) power Acting Director, Information Collection cycles utilize natural gas or syngas oxy- Take notice that the following Clearance Division, Office of the Chief Privacy combustion systems to produce a high hydroelectric application has been filed Officer, Office of Management. temperature SCO2 working fluid and with the Commission and is available [FR Doc. 2017–24533 Filed 11–9–17; 8:45 am] have the potential to be efficient, cost for public inspection. BILLING CODE 4000–01–P effective and well-suited for carbon a. Type of Application: Original major dioxide (CO2) capture. To realize the license. benefits of direct fired SCO2 power b. Project No.: P–14795–002. DEPARTMENT OF ENERGY cycles, the following challenges must be c. Date filed: November 1, 2017. addressed: Chemical kinetic d. Applicant: Shell Energy North Notice of Public Meeting of the uncertainties, combustion instability, America (US), LP. Supercritical CO2 Oxy-combustion flowpath design, thermal management, e. Name of Project: Hydro Battery Technology Group pressure containment, definition/ Pearl Hill Pumped Storage Project. prediction of turbine inlet conditions, f. Location: On the Columbia River AGENCY: National Energy Technology ignition, off-design operation, transient and Rufus Woods Lake, near Bridgeport, Laboratory, Office of Fossil Energy, capabilities, in-situ flame monitoring, Douglas County, Washington. The Department of Energy. and modeling, among others. project would be located on state lands ACTION: Notice of public meeting. The format of the meeting will and the lower reservoir and power facilitate equal opportunity for generation and pumping equipment SUMMARY: The National Energy discussion among all participants; all would be located on Rufus Woods Lake, Technology Laboratory (NETL) will host participants will be welcome to speak. a reservoir operated by the Army Corps a public meeting via WebEx December Following a detailed presentation by of Engineers. 11, 2017, of the Supercritical CO2 Oxy- one volunteer participant regarding g. Filed Pursuant to: Federal Power combustion Technology Group, to lessons learned from his or her area of Act 16 U.S.C. 791(a)–825(r). address challenges associated with oxy- research, other participants will be h. Applicant Contact: Kent Watt, combustion systems in directly heated provided the opportunity to briefly Shell US Hosting Company, Shell supercritical CO2 (sCO2) power cycles. share lessons learned from their own Woodcreek Office, 150 North Dairy DATES: The public meeting will be held research. Meetings are expected to take Ashford, Houston, TX 77079, (832) 337– on December 11, 2017, from 1:00 p.m. place every other month with a different 1160, [email protected]. to 3:00 p.m. volunteer presenting at each meeting. i. FERC Contact: Ryan Hansen, 888 ADDRESSES: The public meeting will be Meeting minutes shall be published for 1st St. NE., Washington, DC 20426, held via WebEx and hosted by NETL. those who are unable to attend. (202) 502–8074, [email protected].
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j. Cooperating agencies: Federal, state, fish screen; (5) a 2,500-foot-long, 24.9- Accession Number: 20171103–5182. local, and tribal agencies with kilovolt buried/affixed transmission line Comments Due: 5 p.m. ET 11/24/17. jurisdiction and/or special expertise interconnecting to an existing non- Take notice that the Commission with respect to environmental issues project transmission line; (6) an received the following electric rate that wish to cooperate in the approximately 3,847-foot long gravel filings: preparation of the environmental access road; and (7) appurtenant Docket Numbers: ER18–245–000. document should follow the facilities. The average annual generation Applicants: Georgia Power Company. instructions for filing such requests is estimated to be 24 gigawatt-hours. Description: § 205(d) Rate Filing: described in item l below. Cooperating o. A copy of the application is GPCo 2017 PBOP Filing to be effective agencies should note the Commission’s available for review at the Commission 1/1/2017. policy that agencies that cooperate in in the Public Reference Room or may be Filed Date: 11/3/17. the preparation of the environmental viewed on the Commission’s Web site at Accession Number: 20171103–5116. document cannot also intervene. See, 94 http://www.ferc.gov using the eLibrary Comments Due: 5 p.m. ET 11/24/17. FERC 61,076 (2001). link. Enter the docket number excluding k. Pursuant to section 4.32(b)(7) of 18 the last three digits in the docket Docket Numbers: ER18–246–000. CFR of the Commission’s regulations, if number field to access the document. Applicants: Arizona Public Service any resource agency, Indian Tribe, or For assistance, contact FERC Online Company. person believes that an additional Support. A copy is also available for Description: Compliance filing: Rate scientific study should be conducted in inspection and reproduction at the Schedule No. 289—SCE Expiration order to form an adequate factual basis address in item h above. Agreement to be effective 12/22/2015. for a complete analysis of the You may also register online at http:// Filed Date: 11/3/17. application on its merit, the resource www.ferc.gov/docs-filing/ Accession Number: 20171103–5118. agency, Indian Tribe, or person must file esubscription.asp to be notified via Comments Due: 5 p.m. ET 11/24/17. a request for a study with the email of new filings and issuances Docket Numbers: ER18–247–000. Commission not later than 60 days from related to this or other pending projects. Applicants: Mississippi Power the date of filing of the application, and For assistance, contact FERC Online Company. serve a copy of the request on the Support. Description: § 205(d) Rate Filing: applicant. p. Procedural schedule: The PBOP 2017 Filing to be effective 1/1/ l. Deadline for filing additional study application will be processed according 2017. requests and requests for cooperating to the following preliminary schedule. Filed Date: 11/3/17. agency status: January 2, 2018. At this time we anticipate issuing a Accession Number: 20171103–5119. The Commission strongly encourages single EA. Revisions to the schedule Comments Due: 5 p.m. ET 11/24/17. electronic filing. Please file additional will be made as appropriate. Docket Numbers: ER18–248–000. study requests and requests for Issue Notice of Acceptance—February Applicants: Southern Electric cooperating agency status using the 2018 Generating Company. Commission’s eFiling system at http:// Issue Scoping Document 1 for Description: § 205(d) Rate Filing: www.ferc.gov/docs-filing/efiling.asp. For comments—March 2018 SEGCo 2017 PBOP Filing to be effective assistance, please contact FERC Online Comments on Scoping Document 1— 1/1/2017. Support at FERCOnlineSupport@ May 2018 Filed Date: 11/3/17. ferc.gov, (866) 208–3676 (toll free), or Issue Scoping Document 2—June 2018 Accession Number: 20171103–5120. (202) 502–8659 (TTY). In lieu of Issue notice of ready for environmental Comments Due: 5 p.m. ET 11/24/17. electronic filing, please send a paper analysis—May 2018 copy to: Secretary, Federal Energy Docket Numbers: ER18–249–000. Commission issues EA—November 2018 Applicants: Public Service Company Regulatory Commission, 888 First Street Comments on EA—December 2018 NE., Washington, DC 20426. The first of New Mexico. Dated: November 6, 2017. Description: Initial rate filing: page of any filing should include docket Executed TCIA with Western Spirit number P–14795–002. Kimberly D. Bose, m. The application is not ready for Secretary. Clean Line LLC to be effective 11/1/ environmental analysis at this time. [FR Doc. 2017–24459 Filed 11–9–17; 8:45 am] 2017. n. The proposed project would utilize BILLING CODE 6717–01–P Filed Date: 11/3/17. the existing U.S. Army Corps of Accession Number: 20171103–5166. Engineers’ Rufus Woods Lake Reservoir, Comments Due: 5 p.m. ET 11/24/17. and would consist of the following new DEPARTMENT OF ENERGY Docket Numbers: ER18–250–000. facilities: (1) A 300-foot-diameter, 20- Applicants: Duke Energy Carolinas, foot-tall lined corrugated steel tank Federal Energy Regulatory LLC. upper reservoir with a storage capacity Commission Description: § 205(d) Rate Filing: DEC- of 26.5 acre-feet; (2) a 3-foot-diameter, Brookfield-TVA Pseudo-Tie Agrmnts to Combined Notice of Filings #2 3,400-foot-long above-ground carbon be effective 11/14/2017. steel penstock transitioning to a 3-foot- Take notice that the Commission Filed Date: 11/3/17. diameter, 2,700-foot-long buried carbon received the following electric corporate Accession Number: 20171103–5173. steel penstock; (3) a 77-foot-long, 77- filings: Comments Due: 5 p.m. ET 11/24/17. foot-wide structural steel power Docket Numbers: EC18–13–000. Docket Numbers: ER18–251–000. platform housing five 2,400 horsepower Applicants: Plum Point Energy Applicants: California Independent vertical turbine pumps, one 5 megawatt Associates, LLC, Plum Point Services System Operator Corporation. twin-jet Pelton turbine and synchronous Company, LLC, Excalibur Power, L.L.C. Description: § 205(d) Rate Filing: generator, and accompanying electrical Description: Application Under FPA 2017–11–03 Powerex Canadian EIM equipment; (4) five vertical turbine Section 203 of Plum Point Energy Entity Agreement to be effective 2/15/ pump intakes, each fitted with a 27- Associates, LLC, et. al. 2018. inch-diameter by 94-inch-long T-style Filed Date: 11/3/17. Filed Date: 11/3/17.
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Accession Number: 20171103–5180. DEPARTMENT OF ENERGY m. Lock 13 Hydro Partners, LLC filed Comments Due: 5 p.m. ET 11/24/17. a Pre-Application Document (PAD; Docket Numbers: ER18–251–001. Federal Energy Regulatory including a proposed process plan and Applicants: California Independent Commission schedule) with the Commission, System Operator Corporation. [Project No. 14799–001] pursuant to 18 CFR 5.6 of the Description: Tariff Amendment: Commission’s regulations. 2017–11–03 Powerex Canadian EIM Lock 13 Hydro Partners, LLC; Notice of n. A copy of the PAD is available for Entity Scheduling Coordinator Intent To File License Application, review at the Commission in the Public Agreement to be effective 2/15/2018. Filing of Pre-Application Document, Reference Room or may be viewed on Filed Date: 11/3/17. and Approving Use of the Traditional the Commission’s Web site (http:// Accession Number: 20171103–5185. Licensing Process www.ferc.gov), using the eLibrary link. Comments Due: 5 p.m. ET 11/24/17. Enter the docket number, excluding the Docket Numbers: ER18–251–002. a. Type of Filing: Notice of Intent to last three digits in the docket number Applicants: California Independent File License Application and Request to field to access the document. For System Operator Corporation. Use the Traditional Licensing Process. assistance, contact FERC Online Description: Tariff Amendment: b. Project No.: 14799–001. Support at FERCONlineSupport@ 2017–11–03 Powerex EIM Participating c. Date Filed: September 7, 2017. ferc.gov, (866) 208–3676 (toll free), or Resource Agreement to be effective d. Submitted By: Lock 13 Hydro (202) 502–8659 (TTY). A copy is also 2/15/2018. Partners, LLC. available for inspection and Filed Date: 11/3/17. e. Name of Project: Evelyn reproduction at the address in Accession Number: 20171103–5196. Hydroelectric Project. Comments Due: 5 p.m. ET 11/24/17. f. Location: On the Kentucky River, in paragraph h. Docket Numbers: ER18–251–003. Lee and Estill Counties, Kentucky. No o. Register online at http:// Applicants: California Independent federal land occupied by the project www.ferc.gov/docs-filing/ System Operator Corporation. works or located within the project esubscription.asp to be notified via Description: Tariff Amendment: boundary. email of new filing and issuances 2017–11–03 Powerex EIM Participating g. Filed Pursuant to: 18 CFR 5.3 of the related to this or other pending projects. Resource Scheduling Coordinator Commission’s regulations. For assistance, contact FERC Online Agreement to be effective 2/15/2018. h. Potential Applicant Contact: David Support. Filed Date: 11/3/17. Brown Kinloch, Lock 13 Hydro Partners, Dated: November 6, 2017. Accession Number: 20171103–5203. LLC, 414 S. Wenzel Street, Louisville, Kimberly D. Bose, Comments Due: 5 p.m. ET 11/24/17. KY 40204; (502) 589–0975; email— Secretary. Docket Numbers: ER18–251–004. [email protected]. Applicants: California Independent [FR Doc. 2017–24460 Filed 11–9–17; 8:45 am] i. FERC Contact: Sarah Salazar at BILLING CODE 6717–01–P System Operator Corporation. (202) 502–6863; or email at Description: Tariff Amendment: [email protected]. 2017–11–03 CAISO and BC Hydro Data j. Lock 13 Hydro Partners, LLC filed DEPARTMENT OF ENERGY Sharing Agreement to be effective 2/15/ its request to use the Traditional 2018. Licensing Process on September 7, 2017. Federal Energy Regulatory Filed Date: 11/3/17. Accession Number: 20171103–5206. Lock 13 Hydro Partners, LLC provided Commission public notice of its request on Comments Due: 5 p.m. ET 11/24/17. [Docket No. ER18–236–000] September 14, 2017. In a letter dated The filings are accessible in the November 6, 2017, the Director of the Commission’s eLibrary system by GSP Merrimack LLC; Supplemental Division of Hydropower Licensing clicking on the links or querying the Notice That Initial Market-Based Rate approved Lock 13 Hydro Partners, LLC’s docket number. Filing Includes Request for Blanket Any person desiring to intervene or request to use the Traditional Licensing Section 204 Authorization protest in any of the above proceedings Process. This is a supplemental notice in the must file in accordance with Rules 211 k. With this notice, we are initiating above-referenced proceeding of GSP and 214 of the Commission’s informal consultation with the U.S. Fish Merrimack LLC’s application for Regulations (18 CFR 385.211 and and Wildlife Service and/or NOAA market-based rate authority, with an 385.214) on or before 5:00 p.m. Eastern Fisheries under section 7 of the accompanying rate tariff, noting that time on the specified comment date. Endangered Species Act and the joint such application includes a request for Protests may be considered, but agency regulations thereunder at 50 blanket authorization, under 18 CFR intervention is necessary to become a CFR, Part 402. We are also initiating part 34, of future issuances of securities party to the proceeding. consultation with the Kentucky State eFiling is encouraged. More detailed Historic Preservation Officer, as and assumptions of liability. information relating to filing required by section 106 of the National Any person desiring to intervene or to requirements, interventions, protests, Historic Preservation Act, and the protest should file with the Federal service, and qualifying facilities filings implementing regulations of the Energy Regulatory Commission, 888 can be found at: http://www.ferc.gov/ Advisory Council on Historic First Street NE., Washington, DC 20426, docs-filing/efiling/filing-req.pdf. For Preservation at 36 CFR 800.2. in accordance with Rules 211 and 214 other information, call (866) 208–3676 l. With this notice, we are designating of the Commission’s Rules of Practice (toll free). For TTY, call (202) 502–8659. Lock 13 Hydro Partners, LLC as the and Procedure (18 CFR 385.211 and Commission’s non-federal 385.214). Anyone filing a motion to Dated: November 3, 2017. representative for carrying out informal intervene or protest must serve a copy Kimberly D. Bose, consultation pursuant to section 7 of the of that document on the Applicant. Secretary. Endangered Species Act and Notice is hereby given that the [FR Doc. 2017–24454 Filed 11–9–17; 8:45 am] consultation pursuant to section 106 of deadline for filing protests with regard BILLING CODE 6717–01–P the National Historic Preservation Act. to the applicant’s request for blanket
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authorization, under 18 CFR part 34, of Energy Regulatory Commission, 888 DEPARTMENT OF ENERGY future issuances of securities and First Street NE., Washington, DC 20426, assumptions of liability, is November in accordance with Rules 211 and 214 Federal Energy Regulatory 24, 2017. of the Commission’s Rules of Practice Commission The Commission encourages and Procedure (18 CFR 385.211 and [Docket No. ER18–241–000] electronic submission of protests and 385.214). Anyone filing a motion to interventions in lieu of paper, using the intervene or protest must serve a copy Luz Solar Partners Ltd., V; FERC Online links at http:// of that document on the Applicant. Supplemental Notice That Initial www.ferc.gov. To facilitate electronic Market-Based Rate Filing Includes service, persons with Internet access Notice is hereby given that the Request for Blanket Section 204 who will eFile a document and/or be deadline for filing protests with regard Authorization listed as a contact for an intervenor to the applicant’s request for blanket must create and validate an authorization, under 18 CFR part 34, of This is a supplemental notice in the eRegistration account using the future issuances of securities and above-referenced proceeding of Luz eRegistration link. Select the eFiling assumptions of liability, is November Solar Partners Ltd., V’s application for link to log on and submit the 24, 2017. market-based rate authority, with an intervention or protests. accompanying rate tariff, noting that The Commission encourages such application includes a request for Persons unable to file electronically electronic submission of protests and should submit an original and 5 copies blanket authorization, under 18 CFR interventions in lieu of paper, using the part 34, of future issuances of securities of the intervention or protest to the FERC Online links at http:// Federal Energy Regulatory Commission, and assumptions of liability. www.ferc.gov. To facilitate electronic Any person desiring to intervene or to 888 First Street NE., Washington, DC service, persons with Internet access protest should file with the Federal 20426. who will eFile a document and/or be Energy Regulatory Commission, 888 The filings in the above-referenced listed as a contact for an intervenor First Street NE., Washington, DC 20426, proceeding are accessible in the must create and validate an in accordance with Rules 211 and 214 Commission’s eLibrary system by eRegistration account using the of the Commission’s Rules of Practice clicking on the appropriate link in the and Procedure (18 CFR 385.211 and above list. They are also available for eRegistration link. Select the eFiling 385.214). Anyone filing a motion to electronic review in the Commission’s link to log on and submit the intervene or protest must serve a copy Public Reference Room in Washington, intervention or protests. of that document on the Applicant. Persons unable to file electronically DC. There is an eSubscription link on Notice is hereby given that the the Web site that enables subscribers to should submit an original and 5 copies deadline for filing protests with regard receive email notification when a of the intervention or protest to the to the applicant’s request for blanket document is added to a subscribed Federal Energy Regulatory Commission, authorization, under 18 CFR part 34, of docket(s). For assistance with any FERC 888 First Street NE., Washington, DC future issuances of securities and Online service, please email 20426. assumptions of liability, is November [email protected]. or call The filings in the above-referenced 24, 2017. (866) 208–3676 (toll free). For TTY, call proceeding are accessible in the The Commission encourages (202) 502–8659. Commission’s eLibrary system by electronic submission of protests and Dated: November 3, 2017. clicking on the appropriate link in the interventions in lieu of paper, using the Kimberly D. Bose, above list. They are also available for FERC Online links at http:// Secretary. electronic review in the Commission’s www.ferc.gov. To facilitate electronic [FR Doc. 2017–24450 Filed 11–9–17; 8:45 am] Public Reference Room in Washington, service, persons with Internet access who will eFile a document and/or be BILLING CODE 6717–01–P DC. There is an eSubscription link on listed as a contact for an intervenor the Web site that enables subscribers to must create and validate an receive email notification when a eRegistration account using the DEPARTMENT OF ENERGY document is added to a subscribed eRegistration link. Select the eFiling Federal Energy Regulatory docket(s). For assistance with any FERC link to log on and submit the Commission Online service, please email intervention or protests. [email protected] or call Persons unable to file electronically [Docket No. ER18–234–000] (866) 208–3676 (toll free). For TTY, call should submit an original and 5 copies (202) 502–8659. GSP Newington LLC; Supplemental of the intervention or protest to the Notice That Initial Market-Based Rate Dated: November 3, 2017. Federal Energy Regulatory Commission, Filing Includes Request for Blanket Kimberly D. Bose, 888 First Street NE., Washington, DC Section 204 Authorization 20426. Secretary. The filings in the above-referenced This is a supplemental notice in the [FR Doc. 2017–24456 Filed 11–9–17; 8:45 am] proceeding are accessible in the above-referenced proceeding of GSP BILLING CODE 6717–01–P Commission’s eLibrary system by Newington LLC’s application for clicking on the appropriate link in the market-based rate authority, with an above list. They are also available for accompanying rate tariff, noting that electronic review in the Commission’s such application includes a request for Public Reference Room in Washington, blanket authorization, under 18 CFR DC. There is an eSubscription link on part 34, of future issuances of securities the Web site that enables subscribers to and assumptions of liability. receive email notification when a Any person desiring to intervene or to document is added to a subscribed protest should file with the Federal docket(s). For assistance with any FERC
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Online service, please email Filed Date: 11/2/17. and Procedure (18 CFR 385.211 and [email protected]. or call Accession Number: 20171102–5284. 385.214). Anyone filing a motion to (866) 208–3676 (toll free). For TTY, call Comments Due: 5 p.m. ET 11/24/17. intervene or protest must serve a copy (202) 502–8659. Docket Numbers: ER18–244–000. of that document on the Applicant. Dated: November 3, 2017. Applicants: PJM Interconnection, Notice is hereby given that the Kimberly D. Bose, L.L.C. deadline for filing protests with regard Description: § 205(d) Rate Filing: to the applicant’s request for blanket Secretary. Amendment to WMPA SA No. 3234, authorization, under 18 CFR part 34, of [FR Doc. 2017–24458 Filed 11–9–17; 8:45 am] Queue No. W4–060 to be effective future issuances of securities and BILLING CODE 6717–01–P 9/17/2014. assumptions of liability, is November Filed Date: 11/3/17. 24, 2017. Accession Number: 20171103–5097. DEPARTMENT OF ENERGY The Commission encourages Comments Due: 5 p.m. ET 11/24/17. electronic submission of protests and Federal Energy Regulatory The filings are accessible in the interventions in lieu of paper, using the Commission Commission’s eLibrary system by FERC Online links at http:// clicking on the links or querying the www.ferc.gov. To facilitate electronic Combined Notice of Filings #1 docket number. service, persons with Internet access Any person desiring to intervene or who will eFile a document and/or be Take notice that the Commission protest in any of the above proceedings listed as a contact for an intervenor received the following electric rate must file in accordance with Rules 211 must create and validate an filings: and 214 of the Commission’s eRegistration account using the Docket Numbers: ER17–718–001. Regulations (18 CFR 385.211 and eRegistration link. Select the eFiling Applicants: PJM Interconnection, 385.214) on or before 5:00 p.m. Eastern link to log on and submit the L.L.C. time on the specified comment date. intervention or protests. Description: Compliance filing: Protests may be considered, but Persons unable to file electronically Compliance Filing per 10/3/2017 Order intervention is necessary to become a should submit an original and 5 copies re: TMEPs in Docket No. ER17–718 et al party to the proceeding. of the intervention or protest to the to be effective 6/28/2017. eFiling is encouraged. More detailed Federal Energy Regulatory Commission, Filed Date: 11/2/17. information relating to filing 888 First Street NE., Washington, DC Accession Number: 20171102–5254. Comments Due: 5 p.m. ET 11/24/17. requirements, interventions, protests, 20426. service, and qualifying facilities filings The filings in the above-referenced Docket Numbers: ER17–721–001. can be found at: http://www.ferc.gov/ Applicants: Midcontinent proceeding are accessible in the docs-filing/efiling/filing-req.pdf. For Independent System Operator, Inc. Commission’s eLibrary system by other information, call (866) 208–3676 Description: Compliance filing: clicking on the appropriate link in the (toll free). For TTY, call (202) 502–8659. 2017–11–02_Compliance filing re above list. They are also available for Targeted Market Efficiency Dated: November 3, 2017. electronic review in the Commission’s Amendments to be effective 6/28/2017. Kimberly D. Bose, Public Reference Room in Washington, Filed Date: 11/2/17. Secretary. DC. There is an eSubscription link on the Web site that enables subscribers to Accession Number: 20171102–5269. [FR Doc. 2017–24453 Filed 11–9–17; 8:45 am] Comments Due: 5 p.m. ET 11/24/17. receive email notification when a BILLING CODE 6717–01–P Docket Numbers: ER18–241–000. document is added to a subscribed Applicants: Luz Solar Partners Ltd., V. docket(s). For assistance with any FERC Description: Baseline eTariff Filing: DEPARTMENT OF ENERGY Online service, please email Luz Solar Partners Ltd., V Application [email protected], or call for Market-Based Rates to be effective Federal Energy Regulatory (866) 208–3676 (toll free). For TTY, call 1/1/2018. Commission (202) 502–8659. Filed Date: 11/2/17. [Docket No. ER18–238–000] Dated: November 3, 2017. Accession Number: 20171102–5255. Kimberly D. Bose, Comments Due: 5 p.m. ET 11/24/17. GSP Schiller LLC; Supplemental Secretary. Docket Numbers: ER18–242–000. Notice That Initial Market-Based Rate [FR Doc. 2017–24452 Filed 11–9–17; 8:45 am] Applicants: Southern California Filing Includes Request for Blanket BILLING CODE 6717–01–P Edison Company. Section 204 Authorization Description: Notice of Cancellation of the Amended and Restated Mutual This is a supplemental notice in the DEPARTMENT OF ENERGY Assistance Transmission Agreement above-referenced proceeding of GSP (Rate Schedule No. 174) of Southern Schiller LLC’s application for market- Federal Energy Regulatory California Edison Company. based rate authority, with an Commission Filed Date: 11/2/17. accompanying rate tariff, noting that Accession Number: 20171102–5282. such application includes a request for Combined Notice of Filings #1 Comments Due: 5 p.m. ET 11/24/17. blanket authorization, under 18 CFR Docket Numbers: ER18–243–000. part 34, of future issuances of securities Take notice that the Commission Applicants: San Diego Gas & Electric and assumptions of liability. received the following electric rate Company. Any person desiring to intervene or to filings: Description: Notice of Cancellation of protest should file with the Federal Docket Numbers: ER14–2046–004. the Amended and Restated Mutual Energy Regulatory Commission, 888 Applicants: Plum Point Energy Assistance Transmission Agreement First Street NE., Washington, DC 20426, Associates, LLC. (Rate Schedule No. 62) of San Diego Gas in accordance with Rules 211 and 214 Description: Compliance filing: & Electric Company. of the Commission’s Rules of Practice Informational Filing Pursuant to
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Schedule 2 of the MISO OATT to be eFiling is encouraged. More detailed Federal Energy Regulatory Commission, effective N/A. information relating to filing 888 First Street NE., Washington, DC Filed Date: 11/6/17. requirements, interventions, protests, 20426. Accession Number: 20171106–5196. service, and qualifying facilities filings The filings in the above-referenced Comments Due: 5 p.m. ET 11/27/17. can be found at: http://www.ferc.gov/ proceeding are accessible in the Docket Numbers: ER16–2217–005. docs-filing/efiling/filing-req.pdf. For Commission’s eLibrary system by Applicants: Logan Generating other information, call (866) 208–3676 clicking on the appropriate link in the Company, L.P. (toll free). For TTY, call (202) 502–8659. above list. They are also available for Description: Compliance filing: Dated: November 6, 2017. electronic review in the Commission’s Information Filing Pursuant to Schedule Kimberly D. Bose, Public Reference Room in Washington, DC. There is an eSubscription link on 2 of the PJM OATT to be effective N/A. Secretary. Filed Date: 11/6/17. the Web site that enables subscribers to [FR Doc. 2017–24455 Filed 11–9–17; 8:45 am] Accession Number: 20171106–5204. receive email notification when a BILLING CODE 6717–01–P Comments Due: 5 p.m. ET 11/27/17. document is added to a subscribed Docket Numbers: ER17–2515–001. docket(s). For assistance with any FERC Online service, please email Applicants: Chambers Cogeneration, DEPARTMENT OF ENERGY Limited Partnership. [email protected], or call Description: Compliance filing: Federal Energy Regulatory (866) 208–3676 (toll free). For TTY, call Informational Filing Pursuant to Commission (202) 502–8659. Dated: November 3, 2017. Schedule 2 of the PJM OATT to be [Docket No. ER18–237–000] effective N/A. Kimberly D. Bose, Filed Date: 11/6/17. GSP White Lake LLC; Supplemental Secretary. Accession Number: 20171106–5200. Notice That Initial Market-Based Rate [FR Doc. 2017–24451 Filed 11–9–17; 8:45 am] Comments Due: 5 p.m. ET 11/27/17. Filing Includes Request for Blanket BILLING CODE 6717–01–P Docket Numbers: ER18–252–000. Section 204 Authorization Applicants: PJM Interconnection, L.L.C. This is a supplemental notice in the DEPARTMENT OF ENERGY Description: § 205(d) Rate Filing: Rev above-referenced proceeding of GSP to OA, Sched 1, sec 6.4.1 and OATT, Att White Lake LLC’s application for, Federal Energy Regulatory K-Appx, sec 6.4.1 RE: Offer Capping to market-based rate authority, with an Commission accompanying rate tariff, noting that be effective 1/3/2018. [Docket No. ER18–239–000] Filed Date: 11/3/17. such application includes a request for Accession Number: 20171103–5217. blanket authorization, under 18 CFR GSP Lost Nation LLC; Supplemental Comments Due: 5 p.m. ET 11/24/17. part 34, of future issuances of securities Notice That Initial Market-Based Rate and assumptions of liability. Docket Numbers: ER18–253–000. Filing Includes Request for Blanket Any person desiring to intervene or to Section 204 Authorization Applicants: Duke Energy Progress, protest should file with the Federal LLC. Energy Regulatory Commission, 888 This is a supplemental notice in the Description: § 205(d) Rate Filing: DEP- First Street NE., Washington, DC 20426, above-referenced proceeding of GSP French Broad EMC RS Nos. 195 & 210 in accordance with Rules 211 and 214 Lost Nation LLC’s application for to be effective 1/1/2016. of the Commission’s Rules of Practice market-based rate authority, with an Filed Date: 11/3/17. and Procedure (18 CFR 385.211 and accompanying rate tariff, noting that Accession Number: 20171103–5231. 385.214). Anyone filing a motion to such application includes a request for Comments Due: 5 p.m. ET 11/24/17. intervene or protest must serve a copy blanket authorization, under 18 CFR Docket Numbers: ER18–254–000. of that document on the Applicant. part 34, of future issuances of securities Applicants: PJM Interconnection, Notice is hereby given that the and assumptions of liability. L.L.C., Buckeye Power, Inc. deadline for filing protests with regard Any person desiring to intervene or to Description: § 205(d) Rate Filing: to the applicant’s request for blanket protest should file with the Federal Revised SA No. 4753—NITSA among authorization, under 18 CFR part 34, of Energy Regulatory Commission, 888 PJM and Buckeye Power, Inc. to be future issuances of securities and First Street NE., Washington, DC 20426, effective 1/1/2018. assumptions of liability, is November in accordance with Rules 211 and 214 Filed Date: 11/6/17. 24, 2017. of the Commission’s Rules of Practice Accession Number: 20171106–5302. The Commission encourages and Procedure (18 CFR 385.211 and Comments Due: 5 p.m. ET 11/27/17. electronic submission of protests and 385.214). Anyone filing a motion to The filings are accessible in the interventions in lieu of paper, using the intervene or protest must serve a copy Commission’s eLibrary system by FERC Online links at http:// of that document on the Applicant. clicking on the links or querying the www.ferc.gov. To facilitate electronic Notice is hereby given that the docket number. service, persons with Internet access deadline for filing protests with regard Any person desiring to intervene or who will eFile a document and/or be to the applicant’s request for blanket protest in any of the above proceedings listed as a contact for an intervenor authorization, under 18 CFR part 34, of must file in accordance with Rules 211 must create and validate an future issuances of securities and and 214 of the Commission’s eRegistration account using the assumptions of liability, is November Regulations (18 CFR 385.211 and eRegistration link. Select the eFiling 24, 2017. 385.214) on or before 5:00 p.m. Eastern link to log on and submit the The Commission encourages time on the specified comment date. intervention or protests. electronic submission of protests and Protests may be considered, but Persons unable to file electronically interventions in lieu of paper, using the intervention is necessary to become a should submit an original and 5 copies FERC Online links at http:// party to the proceeding. of the intervention or protest to the www.ferc.gov. To facilitate electronic
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service, persons with Internet access DATES: Rate Schedule BCP–F10 is confirmation and approval on a final who will eFile a document and/or be effective as of December 13, 2017, and basis. listed as a contact for an intervenor will remain in effect through September Dated: November 3, 2017. must create and validate an 30, 2022, pending approval by the Dan Brouillette, eRegistration account using the Federal Energy Regulatory Commission Deputy Secretary of Energy. eRegistration link. Select the eFiling (FERC) on a final basis or until link to log on and submit the superseded. The FY 2018 base charge DEPARTMENT OF ENERGY intervention or protests. and rates for BCP are applicable DEPUTY SECRETARY Persons unable to file electronically December 13, 2017, and will remain in should submit an original and 5 copies effect through September 30, 2018. In the matter of: Western Area Power Administration, Boulder Canyon Project of the intervention or protest to the FOR FURTHER INFORMATION CONTACT: Mr. Rate Adjustment for Electric Service Federal Energy Regulatory Commission, Ronald E. Moulton, Regional Manager, Rate Order No. WAPA–178 888 First Street NE., Washington, DC Desert Southwest Region, Western Area 20426. Power Administration, P.O. Box 6457, Order Confirming, Approving and Placing The filings in the above-referenced Phoenix, AZ 85005–6457, (602) 605– Formula Rates for Electric Service Into proceeding are accessible in the 2453, email [email protected] or Mr. Effect on an Interim Basis and Calculation Commission’s eLibrary system by Jack Murray, Vice President of Power of Fiscal Year 2018 Base Charge and Rates clicking on the appropriate link in the Marketing, Desert Southwest Region, The formula rates set forth in this order are above list. They are also available for Western Area Power Administration, established pursuant to Section 302 of the electronic review in the Commission’s P.O. Box 6457, Phoenix, AZ 85005– Department of Energy (DOE) Organization Public Reference Room in Washington, Act (42 U.S.C. 7152). This act transferred to 6457, (602) 605–2555, email jmurray@ and vested in the Secretary of Energy the DC. There is an eSubscription link on wapa.gov. power marketing functions of the Secretary of the Web site that enables subscribers to SUPPLEMENTARY INFORMATION: Rate the Interior and the Bureau of Reclamation receive email notification when a Schedule BCP–F9 under Rate Order No. (Reclamation) under the Reclamation Act of document is added to a subscribed WAPA–171 1 was approved for a five- 1902 (ch. 1093, 32 Stat. 388), as amended and docket(s). For assistance with any FERC year period beginning on October 1, supplemented by subsequent laws, Online service, please email particularly section 9(c) of the Reclamation 2015, and ending September 30, 2020. Project Act of 1939 (43 U.S.C. 485h(c)), and [email protected], or call On June 19, 2017, WAPA proposed to (866) 208–3676 (toll free). For TTY, call other acts that specifically apply to the update the formula rates under Rate project involved. (202) 502–8659. Schedule BCP–F10 and calculate the FY By Delegation Order No. 00–037.00B, Dated: November 3, 2017. 2018 base charge and rates in a notice effective November 19, 2016, the Secretary of Kimberly D. Bose, published in the Federal Register on Energy delegated: (1) The authority to develop power and transmission rates to the Secretary. June 19, 2017 (82 FR 27813). The notice detailed the proposed formula rates, Administrator of the Western Area Power [FR Doc. 2017–24457 Filed 11–9–17; 8:45 am] Administration (WAPA); (2) the authority to initiated a public consultation and BILLING CODE 6717–01–P confirm, approve, and place such rates into comment period, and set forth the date effect on an interim basis to the Deputy and location of public information and Secretary of Energy; and (3) the authority to DEPARTMENT OF ENERGY comment forums. confirm, approve, and place into effect on a By Delegation Order No. 00–037.00B, final basis, to remand, or to disapprove such Western Area Power Administration effective November 19, 2016, the rates to the Federal Energy Regulatory Secretary of Energy delegated: (1) The Commission (FERC). Federal rules (10 CFR Boulder Canyon Project-Rate Order authority to develop power and part 903) govern DOE procedures for public No. WAPA–178 transmission rates to the Administrator participation in power and transmission rate of WAPA; (2) the authority to confirm, adjustments. AGENCY: Western Area Power approve, and place such rates into effect Administration, DOE. Acronyms and Definitions on an interim basis to the Deputy ACTION: Notice of order concerning As used in this Rate Order, the Secretary of Energy; and (3) the following acronyms and definitions formula rates for electric service and authority to confirm, approve, and place calculation of the fiscal year 2018 base apply: into effect on a final basis, to remand, Base Charge: The total charge paid by charge and rates for the Boulder Canyon or to disapprove such rates to FERC. Project. the contractors for their allocated Federal rules (10 CFR part 903) govern contingent capacity and firm energy SUMMARY: The Deputy Secretary of Department of Energy procedures for based on the annual revenue Energy confirmed and approved Rate public participation in power and requirement. The base charge is Order No. WAPA–178 and Rate transmission rate adjustments. composed of a capacity and an energy Under Delegation Order Nos. 00– Schedule BCP–F10, placing formula component. rates for electric service from the 037.00B and 00–001.00F and in Boulder Canyon Project (BCP): All Boulder Canyon Project (BCP) of the compliance with 10 CFR part 903, 10 works and the real property associated Western Area Power Administration CFR part 904 and 18 CFR part 300, I with such works authorized by the hereby confirm, approve and place Rate (WAPA) into effect on an interim basis. Boulder Canyon Project Act, as Order No. WAPA–178, which places The provisional formula rates will amended, the Hoover Power Plant Act formula rates for BCP electric service provide sufficient revenue to pay all of 1984, as amended, and any future into effect on an interim basis, and annual costs, including interest additions authorized by Congress, to be calculates the base charge and rates for expense, and repay required investment constructed and owned by the United FY 2018. Rate Schedule BCP–F10 will within the allowable periods. The States, but exclusive of the main canal be submitted promptly to FERC for Deputy Secretary has also confirmed and its related appurtenances and approved the fiscal year (FY) 2018 authorized by the Boulder Canyon 1 Rate Order No. WAPA–171 was approved by base charge and rates for BCP electric FERC on a final basis on December 11, 2015, in Project Act, known as the All-American service. Docket No. EF15–7–000 (153 FERC ¶ 62,189). Canal.
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Contractor: Any party that has a fully follow. All comments received were Comment: A commenter thanked executed contract with WAPA for BCP considered in preparing this Rate Order. Reclamation and WAPA for their electric service. The comments have been paraphrased collaborative efforts to moderate the DOE: Department of Energy. where appropriate without impact of the working capital collection DSW: Desert Southwest Region. compromising their meaning. in FY 2018 by billing over a 12-month FERC: Federal Energy Regulatory Comment: A commenter requested period rather than a one-time collection. Commission. further explanation of how The commenter also requested that pre- Reclamation: Department of the Reclamation’s $15 million for working 2017 and post-2017 marketing period Interior, Bureau of Reclamation. capital was derived and whether the balances be accounted for separately, WAPA: Western Area Power increase in working capital over the included the post retirement benefit Administration. prior marketing period was necessary. (PRB) amounts. Working Capital: Funds advanced by The commenter requested steps be taken Response: Reclamation and WAPA the contractors to meet BCP cash flow to further moderate the impact of are able to separately identify balances needs. collecting the working capital amount in between pre-2017 and post-2017 the FY 2018 base charge. marketing periods, including PRB Effective Date Response: The greatest need for balances. Rate Schedule BCP–F10 is effective as working capital is generally during the of December 13, 2017, and will remain first quarter of a FY when receipts are Background and Provisional Base in effect through September 30, 2022, not sufficient to cover obligations and Charge and Rates pending approval by FERC on a final expenditures. Because the working The Hoover Dam, authorized by the basis or until superseded. The FY 2018 capital for the new marketing period Boulder Canyon Project Act (45 Stat. base charge and rates are applicable will be incrementally funded over 12 1057, December 21, 1928), sits on the December 13, 2017, and will remain in billing cycles, the full amount will not Colorado River along the Arizona- effect through September 30, 2018. be available until FY 2019. For FY 2018, Nevada border. The Hoover Dam’s the carryover balance from the power plant has 19 generating units Public Notice and Comment marketing period ending September 30, (two for plant use) and an installed WAPA followed the Procedures for 2017, will be available to cover funding capacity of 2,078.8 megawatts (4,800 Public Participation in Power and shortfalls before the full $15 million of kilowatts for plant use). High-voltage Transmission Rate Adjustments and working capital is collected. Because the transmission lines and substations Extensions (10 CFR parts 903) and carryover balance for the marketing deliver this power to southern Nevada, General Regulations for the Charges for period ending September 30, 2017, must Arizona, and southern California. the Sale of Power from the BCP (10 CFR be refunded by September 30, 2018, The rate-setting process for BCP is 904), in developing these formula rates Reclamation must have the $15 million different from most WAPA power and schedule. WAPA took the following in working capital to maintain a positive systems. The Boulder Canyon Project steps to involve the public in the rate cash balance at the end of FY 2018. Amended and Restated Implementation adjustment process: Following the public comment forum, Agreement (BCPIA), executed in 2016 1. WAPA published a Federal Reclamation reviewed their budgets and between WAPA, Reclamation, and Register notice on June 19, 2017 (82 FR revenue projections for FY 2018. To contractors, carried forward the rate 27813), announcing the proposed moderate the base charge increase, methodology used for the marketing formula rates, initiating the 90-day Reclamation was able to further reduce period ending September 30, 2017. This public consultation and comment its replacement budget by $800,000 and rate methodology requires contractors to period, setting forth the date and increased revenue projections for the pay a base charge rather than a unit rate location of public information and Hoover Dam Visitor Center by $3 for power. The base charge is designed public comment forums, and outlining million. This resulted in a net decrease to collect sufficient revenue to cover all the procedures for public participation. to the base charge of $3.8 million. annual costs and to repay investment 2. On July 19, 2017, WAPA held a Comment: A commenter requested obligations within allowable time public information forum in Phoenix, Reclamation’s working capital analysis periods. Each contractor is billed a base Arizona. WAPA’s representatives and footnotes be updated with the latest charge in proportion to their allocation explained the need for the formula rate budget figures reflected in the revised of power from the Hoover Dam. A unit adjustment and proposed changes to the base charge. rate is calculated for comparative formula rates, answered questions, and Response: The analysis was updated purposes but is not used to determine provided presentation handouts. with the revised budget figures and charges for electric service. 3. On August 18, 2017, WAPA held a posted to WAPA’s Web site provided Since a new 50-year marketing period public comment forum in Phoenix, above. There was no change to commences on October 1, 2017, WAPA Arizona, to provide contractors and Reclamation’s working capital needs. is updating the formula rates for a five- interested parties an opportunity to Comment: A commenter thanked all year period and calculating the base comment for the record. parties involved for the efforts made to charge and rates for FY 2018. 4. WAPA posts information about this moderate the impact of Reclamation’s The revision to Rate Schedule BCP– public process at: https:// working capital needs on the in FY 2018 F10 is: www.wapa.gov/regions/DSW/Rates/ base charge. The commenter encouraged Capacity: Shall be equal to the annual Pages/boulder-canyon-rates.aspx. further efforts as well. capacity dollars divided by 2,074 Response: Reclamation and WAPA megawatt hours. This rate is applied to Comments were able to collectively moderate the unauthorized overruns. WAPA received comments from the impact of the working capital collection The existing formula used to calculate Irrigation & Electrical Districts by reducing agency budgets by the forecast capacity rate was revised Association of Arizona and the Colorado approximately $4.5 million. from 1,951 to 2,074 megawatts to reflect River Commission during the public Reclamation and WAPA will continue the current generating (nameplate) consultation and comment period and to work collaboratively to ensure the capacity for the BCP, as required by the responds to them in the paragraphs that stability of the base charge. Hoover Power Allocation Act of 2011.
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No other changes to the formula rates in The update to the FY 2018 formula the rate schedule were proposed. driven base charge and rates are:
FY 2017 FY 2018 Percent base charge base charge change
Base Charge ...... $69,662,289 $76,910,193 10.4 Composite Rates (mills/kWh) ...... 19.63 19.98 1.75
The FY 2018 base charge increased categorically excluded from preparing Applicable from $69.6 million in FY 2017 to $76.9 an environmental assessment or an To power supplied by the Boulder million in FY 2018, a 10.4 percent environmental impact statement. Canyon Project through one meter, at increase. The composite rate increased Determination Under Executive Order one point of delivery, unless otherwise to 19.98 mills per kilowatt month, a 1.75 12866 provided by contract. percent increase. Although the overall BCP budget decreased in FY 2018, the WAPA has an exemption from Character and Conditions of Service establishment of a working capital fund centralized regulatory review under Alternating current at 60 hertz, three- for the new 50-year marketing period Executive Order 12866; accordingly, no phase, delivered and metered at the caused the FY 2018 base charge to clearance of this notice by the Office of voltages and points established by increase. As part of the BCPIA, Management and Budget is required. contract. Reclamation is establishing a $15 Submission to FERC million working capital fund to cover Base Charge short-term liabilities until sufficient The formula rates herein confirmed, The charge paid by each contractor for revenues are received. This fund is approved, and placed into effect on an their allocated capacity and firm energy particularly important at the beginning interim basis, together with supporting based on the annual revenue of a fiscal year when project-related documents, will be submitted to FERC requirement. The base charge shall be expenses tend to be greater than the for confirmation and final approval. composed of a capacity component and revenue collected. This working capital Order an energy component: fund balance will be reviewed annually Capacity Charge: Each month WAPA In view of the foregoing and under the in accordance with the BCPIA. shall bill each contractor for a capacity authority delegated to me, I confirm and charge equal to one-twelfth (1/12) of the Certification of Rates approve, on an interim basis, the capacity dollars multiplied by each formula rates under Rate Schedule BCP– WAPA’s Administrator certified that contractor’s contingent capacity F10. Rate Schedule BCP–F10 is the provisional formula rates for BCP percentage as provided by contract. electric service under Rate Schedule applicable the first full billing period on Energy Charge: Each month WAPA BCP–F10 result in the lowest possible or after November 13, 2017, and will shall bill each contractor for an energy rates consistent with sound business remain in effect through September 30, charge equal to that period’s monthly principles. The provisional formula 2022, pending FERC’s confirmation and energy ratio, multiplied by the rates were developed following approval of the rate schedule or contractor’s energy dollars as provided administrative policies and applicable substitute formula rates on a final basis. by contract. laws. Dated: November 3, 2017. Forecast Rates Availability of Information Dan Brouillette, Deputy Secretary of Energy. Energy: Shall be equal to the annual All brochures, studies, comments, energy dollars divided by the lesser of letters, memorandums and other Rate Schedule BCP–F10 the total master schedule energy or documents used by WAPA to develop (Supersedes Rate Schedule BCP–F9) 4,501 megawatt hours. This rate is the provisional formula rates are applied to excess energy, unauthorized UNITED STATES DEPARTMENT OF available for inspection and copying at overruns, and water pump energy. the Desert Southwest Regional Office, ENERGY Capacity: Shall be equal to the annual Western Area Power Administration, WESTERN AREA POWER capacity dollars divided by 2,074 615 South 43rd Avenue, Phoenix, ADMINISTRATION megawatt hours. This rate is applied to Arizona. Many of these documents are unauthorized overruns. also available on WAPA’s Web site: DESERT SOUTHWEST REGION https://www.wapa.gov/regions/DSW/ Boulder Canyon Project Calculated Energy Rate Rates/Pages/boulder-canyon-rates.aspx. SCHEDULE OF RATES FOR ELECTRIC Within ninety (90) days after the end RATEMAKING PROCEDURE SERVICE of the fiscal year, a calculated energy REQUIREMENTS rate shall be calculated. For any rate Effective year in which energy deemed delivered Environmental Compliance The first day of the first full billing is greater than 4,501 megawatt hours, In compliance with the National period beginning on or after December WAPA shall apply the calculated energy Environmental Policy Act (NEPA) of 13, 2017, and extending through rate to each contractor’s energy deemed 1969, 42 U.S.C. 4321–4347; the Council September 30, 2022, or until superseded delivered to determine the contractor’s on Environmental Quality Regulations by another rate schedule, whichever actual energy charge. A credit or debit for implementing NEPA (40 CFR parts occurs earlier. shall be established for each contractor 1500–1508); and DOE NEPA based on the difference between the Implementing Procedures and Available contractor’s energy dollars and the Guidelines (10 CFR part 1021), WAPA In the marketing area serviced by the contractor’s actual energy charge, to be has determined that this action is Boulder Canyon Project. applied in the month following the
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calculation or as soon as possible and a person is not required to respond in other locations, either by EPA thereafter. to a collection of information unless it researchers, EPA’s regional offices or displays a currently valid OMB control state partners. Cape Cod is in the midst Lower Colorado River Basin number. of an extensive regional planning effort Development Fund (Contribution related to its coastal waters, and this Charge) DATES: Additional comments may be submitted on or before December 13, research can provide helpful socio- The Contribution Charge is 4.5 mills 2017. economic information to decision for each kilowatt hour measured or ADDRESSES: Submit your comments, makers about the use of those waters. scheduled to an Arizona purchaser and Because the 100-mile radius from Cape 2.5 mills for each kilowatt hour referencing Docket ID Number EPA– HQ–ORD–2016–0632, to (1) EPA online Cod includes a large area of southern measured or scheduled to a California or New England and the largest population Nevada purchaser, except for purchased using www.regulations.gov (our preferred method), by email to Docket_ centers in New England, the results will power. [email protected], or by mail to: EPA be more broadly applicable to residents Billing for Unauthorized Overruns Docket Center, Environmental of southern New England. One of the key water quality concerns For each billing period in which there Protection Agency, Mail Code 28221T, 1200 Pennsylvania Ave. NW., on Cape Cod, and throughout New is a contract violation involving an England, is nonpoint sources of unauthorized overrun of contractual Washington, DC 20460, and (2) OMB via email to [email protected]. nitrogen, which lead to ecological power obligations, such overrun shall be impairments in estuaries, with resultant billed at ten (10) times the forecast Address comments to OMB Desk Officer for EPA. socio-economic impacts. The decisions energy rate and forecast capacity rate. needed to meet water quality standards The Contribution Charge shall also be EPA’s policy is that all comments received will be included in the public are highly complex and involve applied to each kilowatt hour of significant cross-disciplinary challenges overrun. docket without change including any personal information provided, unless in identifying, implementing, and Adjustments the comment includes profanity, threats, monitoring social and ecological None. information claimed to be Confidential management needs. We will focus on Business Information (CBI) or other understanding recreational uses as [FR Doc. 2017–24496 Filed 11–9–17; 8:45 am] information whose disclosure is valued economic goods in coastal New BILLING CODE 6450–01–P restricted by statute. England (including beachgoing, FOR FURTHER INFORMATION CONTACT: swimming, fishing, shellfishing, and Marisa Mazzotta, U.S. Environmental boating). ENVIRONMENTAL PROTECTION Protection Agency, Office of Research Form Numbers: 6000–02 and 6000– AGENCY and Development, Atlantic Ecology 03. [EPA–HQ–ORD–2016–0632; FRL–9959–51– Division, 27 Tarzwell Drive, Respondents/affected entities: OEI] Narragansett, Rhode Island 02882; Individuals and Households. telephone number: 401–782–3026; fax Respondent’s obligation to respond: Information Collection Request number: 401–782–3139; email address: Voluntary. Submitted to OMB for Review and [email protected]. Estimated number of respondents: Approval; Comment Request; SUPPLEMENTARY INFORMATION: 2,455 (total). Willingness To Pay Survey To Evaluate Supporting documents which explain in Frequency of response: Once. Recreational Benefits of Nutrient detail the information that the EPA will Total estimated burden: 205 hours Reductions in Coastal New England be collecting are available in the public (per year). Burden is defined at 5 CFR Waters (New) docket for this ICR. The docket can be 1320.03(b). Total estimated cost: $7,129 (per AGENCY: Environmental Protection viewed online at www.regulations.gov year), includes $0 annualized capital or Agency (EPA). or in person at the EPA Docket Center, operation & maintenance costs. ACTION: Notice. WJC West, Room 3334, 1301 Constitution Ave. NW., Washington, Changes in the Estimates: This is a SUMMARY: The Environmental Protection DC. The telephone number for the new collection. Agency has submitted an information Docket Center is 202–566–1744. For Courtney Kerwin, collection request (ICR), ‘‘Willingness to additional information about EPA’s Director, Collection Strategies Division. Pay Survey to Evaluate Recreational public docket, visit http://www.epa.gov/ [FR Doc. 2017–24446 Filed 11–9–17; 8:45 am] Benefits of Nutrient Reductions in dockets. Coastal New England Waters (New)’’ Abstract: Researchers at the EPA’s BILLING CODE 6560–50–P (EPA ICR No. 2558.01, OMB Control No. Office of Research and Development 2080–NEW) to the Office of (ORD), Atlantic Ecology Division (AED) Management and Budget (OMB) for are piloting an effort to better FEDERAL ACCOUNTING STANDARDS review and approval in accordance with understand how reduced water quality ADVISORY BOARD the Paperwork Reduction Act. This is a due to nutrient enrichment affects the Notice of Issuance of Technical request for approval of a new collection. economic prosperity, social capacity, Bulletin 2017–2, Assigning Assets to Public comments were previously and ecological integrity of coastal New Component Reporting Entities requested via the Federal Register (81 England communities. This project FR 78809) on 11/09/2016 during a 60- proposes a survey to collect data for a AGENCY: Federal Accounting Standards day comment period. This notice allows case study of changes in recreation Advisory Board. for an additional 30 days for public demand and values due to changes in ACTION: Notice. comments. A fuller description of the nutrients in northeastern coastal waters. ICR is given below, including its This includes the development of Pursuant to 31 U.S.C. 3511(d), the estimated burden and cost to the public. methods and tools for estimating Federal Advisory Committee Act (Pub. An Agency may not conduct or sponsor recreational values that can be applied L. 92–463), as amended, and the FASAB
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Rules of Procedure, as amended in FEDERAL RESERVE SYSTEM FEDERAL RESERVE SYSTEM October 2010, notice is hereby given that the Federal Accounting Standards Formations of, Acquisitions by, and Notice of Proposals To Engage in or Advisory Board (FASAB) has issued Mergers of Bank Holding Companies To Acquire Companies Engaged in Technical Bulletin 2017–2, Assigning Permissible Nonbanking Activities The companies listed in this notice Assets to Component Reporting Entities. The companies listed in this notice have applied to the Board for approval, The Technical Bulletin is available on have given notice under section 4 of the pursuant to the Bank Holding Company the FASAB Web site at http:// Bank Holding Company Act (12 U.S.C. www.fasab.gov/accounting-standards/. Act of 1956 (12 U.S.C. 1841 et seq.) 1843) (BHC Act) and Regulation Y, (12 Copies can be obtained by contacting (BHC Act), Regulation Y (12 CFR part CFR part 225) to engage de novo, or to FASAB at (202) 512–7350. 225), and all other applicable statutes acquire or control voting securities or and regulations to become a bank assets of a company, including the FOR FURTHER INFORMATION CONTACT: Ms. holding company and/or to acquire the companies listed below, that engages Wendy M. Payne, Executive Director, assets or the ownership of, control of, or either directly or through a subsidiary or 441 G Street NW., Mailstop 6H19, the power to vote shares of a bank or other company, in a nonbanking activity Washington, DC 20548, or call (202) bank holding company and all of the that is listed in § 225.28 of Regulation Y 512–7350. banks and nonbanking companies (12 CFR 225.28) or that the Board has Authority: Federal Advisory Committee owned by the bank holding company, determined by Order to be closely Act, Pub. L. 92–463. including the companies listed below. related to banking and permissible for Dated: November 1, 2017. The applications listed below, as well bank holding companies. Unless otherwise noted, these activities will be Wendy M. Payne, as other related filings required by the conducted throughout the United States. Executive Director. Board, are available for immediate inspection at the Federal Reserve Bank Each notice is available for inspection [FR Doc. 2017–24510 Filed 11–9–17; 8:45 am] at the Federal Reserve Bank indicated. indicated. The applications will also be BILLING CODE 1610–02–P The notice also will be available for available for inspection at the offices of inspection at the offices of the Board of the Board of Governors. Interested Governors. Interested persons may FEDERAL ACCOUNTING STANDARDS persons may express their views in express their views in writing on the ADVISORY BOARD writing on the standards enumerated in question whether the proposal complies the BHC Act (12 U.S.C. 1842(c)). If the with the standards of section 4 of the Notice of Issuance of Technical proposal also involves the acquisition of BHC Act. Bulletin 2017–1, Intragovernmental a nonbanking company, the review also Unless otherwise noted, comments Exchange Transactions includes whether the acquisition of the regarding the applications must be nonbanking company complies with the received at the Reserve Bank indicated AGENCY: Federal Accounting Standards standards in section 4 of the BHC Act or the offices of the Board of Governors Advisory Board. (12 U.S.C. 1843). Unless otherwise not later than November 29, 2017. ACTION: Notice. noted, nonbanking activities will be A. Federal Reserve Bank of Kansas conducted throughout the United States. City (Dennis Denney, Assistant Vice Pursuant to 31 U.S.C. 3511(d), the Unless otherwise noted, comments President) 1 Memorial Drive, Kansas Federal Advisory Committee Act (Pub. regarding each of these applications City, Missouri 64198–0001: L. 92–463), as amended, and the FASAB must be received at the Reserve Bank 1. Henderson State Company, Rules Of Procedure, as amended in indicated or the offices of the Board of Henderson, Nebraska; to engage in lending activities, pursuant to section October 2010, notice is hereby given Governors not later than December 7, 225.28(b)(1) of Regulation Y. that the Federal Accounting Standards 2017. Advisory Board (FASAB) has issued A. Federal Reserve Bank of St. Louis Technical Bulletin 2017–1, Board of Governors of the Federal Reserve (David L. Hubbard, Senior Manager) Intragovernmental Exchange System, November 6, 2017. P.O. Box 442, St. Louis, Missouri Transactions. Michele Taylor Fennell, 63166–2034. Comments can also be sent Assistant Secretary of the Board. The Technical Bulletin is available on electronically to [FR Doc. 2017–24431 Filed 11–9–17; 8:45 am] the FASAB Web site at http:// [email protected]: www.fasab.gov/accounting-standards/. BILLING CODE 6210–01–P Copies can be obtained by contacting 1. Southern Missouri Bancorp, Inc., FASAB at (202) 512–7350. Poplar Bluff, Missouri; to merge with Southern Missouri Bancshares, Inc., FEDERAL RESERVE SYSTEM FOR FURTHER INFORMATION CONTACT: Ms. Marshfield, Missouri, and thereby Wendy M. Payne, Executive Director, indirectly acquire Southern Missouri Change in Bank Control Notices; Acquisitions of Shares of a Bank or 441 G Street NW., Mailstop 6H19, Bank of Marshfield, Marshfield, Bank Holding Company Washington, DC 20548, or call (202) Missouri. 512–7350. Board of Governors of the Federal Reserve The notificants listed below have Authority: Federal Advisory Committee System, November 6, 2017. applied under the Change in Bank Act, Pub. L. 92–463. Michele Taylor Fennell, Control Act (12 U.S.C. 1817(j)) and Dated: November 1, 2017. § 225.41 of the Board’s Regulation Y (12 Assistant Secretary of the Board. CFR 225.41) to acquire shares of a bank Wendy M. Payne, [FR Doc. 2017–24432 Filed 11–9–17; 8:45 am] or bank holding company. The factors Executive Director. BILLING CODE 6210–01–P that are considered in acting on the [FR Doc. 2017–24509 Filed 11–9–17; 8:45 am] notices are set forth in paragraph 7 of BILLING CODE 1610–02–P the Act (12 U.S.C. 1817(j)(7)).
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The notices are available for ADDRESSES: The public scoping meeting impacts. In addition, the ‘‘No Action’’ immediate inspection at the Federal will be held in the City Council alternative will be analyzed. Reserve Bank indicated. The notices Chambers at 1090 E. Union Street, San Alternative 1—GSA will demolish also will be available for inspection at Luis, AZ, where GSA will meet with then reconstruct a modernized LPOE. the offices of the Board of Governors. governmental and public stakeholders The existing San Luis LPOE will be Interested persons may express their to explain the project, and obtain input demolished and reconstructed in four views in writing to the Reserve Bank on the scoping of the project. The (4) phases. Some adjacent land on the indicated for that notice or to the offices meeting will be an informal open house, west side of the LPOE will be acquired of the Board of Governors. Comments where visitors may come, receive which will allow modernization of the must be received not later than information, and provide written November 27, 2017. comments. facility to accommodate modern A. Federal Reserve Bank of San operational requirements, and alleviate FOR FURTHER INFORMATION CONTACT: Francisco (Gerald C. Tsai, Director, traffic strain in downtown San Luis. Osmahn Kadri, Regional Environmental Applications and Enforcement) 101 Alternative 2—Renovate, expand, and Quality Advisor/NEPA PM, by phone at Market Street, San Francisco, California modernize the existing LPOE. GSA will 415–522–3617 or via email at 94105–1579: renovate and modernize the existing 1. Matthew Moskowitz, Plainview, [email protected]. Please also call this number if special assistance is San Luis LPOE and expand the existing New York; Yaakov Markowitz, Brooklyn, footprint of the facility on the west as New York; Jarret Prussin, Westport, needed to attend and participate in the public scoping meeting. mentioned in Alternative 1 which will Connecticut; Paul Brown, Monte Carlo, accommodate modern operational SUPPLEMENTARY INFORMATION: Monaco; and Menachem Wilenkin, GSA requirements, and alleviate traffic strain intends to prepare an EIS to analyze the Brooklyn, New York; to acquire voting in downtown San Luis. shares of All West Bancorp, and thereby potential impacts resulting from indirectly acquire shares of FinWise proposed modifications and design Alternative 3—No Action Alternative. Bank, both of Sandy, Utah. changes to the San Luis I LPOE GSA will continue operations at the modernization project. The San Luis I existing LPOE facilities as they are Board of Governors of the Federal Reserve currently configured and will not System, November 7, 2017. LPOE consists of several facilities that are in need of modernization. perform any renovation nor Yao-Chin Chao, The primary users of the LPOE are modernization of the LPOE. Assistant Secretary of the Board. officers belonging to Customs and The EIS will address the potential [FR Doc. 2017–24522 Filed 11–9–17; 8:45 am] Border Protection and Immigrations and environmental impacts of the proposed BILLING CODE P Customs Enforcement, as well as the alternatives of the including aesthetics, general public seeking to enter or exit air quality during construction and the country. The LPOE needs operation, geology and soils, hazards GENERAL SERVICES modernization due to unacceptable ADMINISTRATION and hazardous materials, hydrology and building conditions and increasing water quality, land use, noise during [Notice–PBS–2017–03; Docket 2017–0002; traffic demand. construction and operation, utilities, Sequence 22] Currently, the LPOE is physically and traffic. The EIS will also address the constrained on both the north and socioeconomic effects of the project. Notice of Intent To Prepare a south, by Urtuzuastegui Street and the Supplemental Environmental Impact Mexico-U.S. border, respectively. Traffic Scoping Process: Scoping will be Statement for the Modernization of the from the LPOE must be routed into accomplished through a public scoping San Luis I Land Port of Entry (LPOE) downtown San Luis, which often meeting, direct mail correspondence to Modernization creates traffic jams. All vehicular traffic appropriate federal, state, and local coming into town has been rerouted agencies, and to private organizations AGENCY: Public Building Service, (PBS), and citizens who have previously General Services Administration (GSA). recently to exit via First Street, while outgoing traffic enters the port via Main expressed, or are known to have, an ACTION: Notice of intent; announcement Street. interest in the project. of meeting. The possible phasing for the This meeting will be announced in SUMMARY: Pursuant to the requirements demolition and modernization of the the local newspaper, the Yuma Sun. of the National Environmental Policy LPOE includes: Agencies and the public are encouraged Act of 1969 (NEPA), the Council on • Phase 1: Acquire a portion of to provide written comments regarding Environmental Quality Regulations, and Friendship Park, a Public-Facing the scope of the EIS. Written comments the GSA Public Buildings Service NEPA Building, Parking Garage, Vault, must be received by Friday, December Desk Guide, GSA is issuing this notice Impound, and Utility Yard. 22, 2017, and sent to the General to advise the public that an • Phase 2: Construct new privately Services Administration, Attention: Environmental Impact Statement (EIS) owned vehicle processing facilities and Osmahn Kadri, Regional Environmental will be prepared for the San Luis I kennel. Quality Advisor/NEPA PM, 450 Golden LPOE. The action to be evaluated by this • Phase 3: Construct new main Gate Avenue, 3rd Floor East, San EIS is the modernization of the existing building and outbound east exits. Francisco, CA, 94102, or via email to San Luis I LPOE, located in San Luis, • Phase 4: Demolish main building, [email protected]. Arizona, to improve its functionality, construct pedestrian processing, and Dated: November 2, 2017. capacity, and security. construct outbound west exits. DATES: Meeting Date: A public scoping Alternatives Under Consideration: Matthew Jear, meeting will be held on Wednesday, Two modernization alternatives for the Director, Portfolio Management Division, November 29, 2017, from 4:00 p.m., proposed project are currently under Pacific Rim Region, Public Buildings Service. Mountain Standard Time (MST), to 6:00 consideration and will be analyzed in [FR Doc. 2017–24551 Filed 11–9–17; 8:45 am] p.m., MST. the EIS for the potential environmental BILLING CODE 6820–YF–P
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DEPARTMENT OF HEALTH AND 395–5806. Provide written comments average of 95.85 points to 139.72 points. HUMAN SERVICES within 30 days of notice publication. This represents an improvement in the total number of intervention strategies Proposed Project Centers for Disease Control and being implemented as well as the Prevention CDC Worksite Health Scorecard (OMB number of best practice and high-impact Control Number 0920–1014, expired 4/ strategies, which garner more points [30Day–17–1014] 30/2017)—Reinstatement with Change— improving the work environment for National Center for Chronic Disease employees to improve their health and Agency Forms Undergoing Paperwork Prevention and Health Promotion well-being. Overall, exposure to the Reduction Act Review (NCCDPHP), Centers for Disease Control Scorecard is contributing to better and and Prevention (CDC). In accordance with the Paperwork more effective work-place health Reduction Act of 1995, the Centers for Background and Brief Description program offerings to employees. Disease Control and Prevention (CDC) CDC will recruit a convenience The Centers for Disease Control and sample of one hundred employers (each has submitted the information Prevention (CDC) has established the collection request titled CDC Worksite represented by two knowledgeable Worksite Health Scorecard (Scorecard), employees for 200 total respondents) to Health Scorecard to the Office of an online organizational assessment Management and Budget (OMB) for pilot test and evaluate the updated tool, to enable employers to assess the Scorecard. CDC will seek a diverse set review and approval. CDC previously number of evidence-based health of employers with respect to size and published a ‘‘Proposed Data Collection promotion interventions or strategies in industry type who will be reached Submitted for Public Comment and their worksites to prevent heart disease, through meetings, presentations, and Recommendations’’ notice on March 2, stroke, and related conditions such as through gatekeeper organizations to be 2017 to obtain comments from the hypertension, diabetes, and obesity. enrolled/registered. The updated public and affected agencies. CDC The CDC Worksite Health Scorecard Scorecard includes questions in four received three comments related to the will support small, mid-size, and large new topic areas: Sleep (8 questions); previous notice. This notice serves to employer with three primary goals: (1) Alcohol & Other Substance Abuse (6 allow an additional 30 days for public Assist employers in identifying gaps in questions); Cancer (7 questions); and and affected agency comments. their health promotion programs, and Musculoskeletal Disorders (7 questions), CDC will accept all comments for this help them to prioritize high-impact to include minor revisions to previously proposed information collection project. strategies for health promotion at their existing questions or adjustment in the The Office of Management and Budget worksites; (2) Improve the health and associated points received for answering is particularly interested in comments wellbeing of employees and their affirmatively to a question based on that: families through science-based supporting evidence from the peer (a) Evaluate whether the proposed workplace health interventions and reviewed literature as well as sources collection of information is necessary promising practices; and (3) Support such as the Community Guide. for the proper performance of the research and increase understanding of Additional updates also included functions of the agency, including the organizational programs, policies, dropping 20 questions from the prior whether the information will have and practices that employers of various version due to redundancy or lack of practical utility; sizes and industry sectors have evidence to support their use. From the (b) Evaluate the accuracy of the implemented to support healthy employers that complete the survey, agencies estimate of the burden of the lifestyle behaviors. CDC will conduct follow-up telephone proposed collection of information, The Scorecard approval under OMB interviews on a subset of about 16 including the validity of the Control number 0920–1014 expired at a employers (each represented by two methodology and assumptions used; time when it was unclear if resources knowledgeable employees, for 32 (c) Enhance the quality, utility, and would be available to continue its use. respondents in total). The follow-up clarity of the information to be Strong commitments from internal and telephone interviews will gather general collected; external stakeholders have enabled CDC impressions of the Scorecard— (d) Minimize the burden of the to continue to offer a revised Scorecard particularly the new modules and allow collection of information on those who to employers nationwide. CDC is for discussion of items that presented are to respond, including, through the requesting a reinstatement with change discrepancies (and items that were left use of appropriate automated, to a previously approved data blank) to understand the respondent’s electronic, mechanical, or other collection. CDC plans to first pilot test interpretation and perspective of their technological collection techniques or an updated version of the Scorecard and answers these questions. This process other forms of information technology, when finalized submit a revision will assess the validity and reliability of e.g., permitting electronic submission of request to expand the number of the questions, as well as allow CDC to responses; and employers the new Scorecard is offered gather suggestions for additional (e) Assess information collection to. refinements, where necessary. costs. From 2014–2016, 1,531 worksites Following this pilot testing, CDC will To request additional information on have submitted CDC Worksite Health continue to provide outreach to and the proposed project or to obtain a copy Scorecards from employers in 40 register approximately 800 employers of the information collection plan and different states. The average employer is per year to use the online survey instruments, call (404) 639–7570 or implementing a little more than half of Scorecard in their workplace health send an email to [email protected]. Direct the recommended programmatic, policy, program assessment, planning, and written comments and/or suggestions environmental support, and health- implementation efforts, which is open regarding the items contained in this benefit intervention strategies assessed to employers of all sizes, industry notice to the Attention: CDC Desk in the Scorecard. Additionally, those sectors, and geographic locations across Officer, Office of Management and employers who have re-assessed at least the country. Budget, 725 17th Street NW., once during this period have seen their CDC requests a one-year OMB Washington, DC 20503 or by fax to (202) Scorecard score improve from an approval for this project. CDC will pilot
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test the updated Scorecard in year one will submit a finalized instrument as a are no costs to respondents other than and create a finalized version of the revision request for a three-year their time. The total estimated instrument based on respondent clearance. annualized burden hours are 303. feedback gathered during the pilot. After Participation in the CDC Worksite the completion of the pilot test, CDC Health Scorecard is voluntary and there
ESTIMATED ANNUALIZED BURDEN HOURS
Average Type of Number of Number of burden per respondent Form name respondents responses per response respondent (in hours)
Employer pilot ...... CDC Worksite Health Scorecard Registration Application .... 200 1 2/60 CDC Worksite Health Scorecard ...... 200 1 1.25 CDC Worksite Health Scorecard Cognitive interview ...... 32 1 1 CDC Worksite Health Scorecard Pilot evaluation ...... 200 1 5/60
Leroy A. Richardson, • Federal eRulemaking Portal: The OMB is particularly interested in Chief, Information Collection Review Office, Regulations.gov. Follow the instructions comments that will help: Office of Scientific Integrity, Office of the for submitting comments. 1. Evaluate whether the proposed Associate Director for Science, Office of the • Mail: Leroy A. Richardson, collection of information is necessary Director, Centers for Disease Control and Information Collection Review Office, for the proper performance of the Prevention. Centers for Disease Control and functions of the agency, including [FR Doc. 2017–24472 Filed 11–9–17; 8:45 am] Prevention, 1600 Clifton Road NE., MS– whether the information will have BILLING CODE 4163–18–P D74, Atlanta, Georgia 30329. practical utility; 2. Evaluate the accuracy of the Instructions: All submissions received agency’s estimate of the burden of the must include the agency name and DEPARTMENT OF HEALTH AND proposed collection of information, Docket Number. CDC will post, without HUMAN SERVICES including the validity of the change, all relevant comments to methodology and assumptions used; Regulations.gov. Centers for Disease Control and 3. Enhance the quality, utility, and Prevention Please note: Submit all comments clarity of the information to be [60Day–18–18AG; Docket No. CDC–2017– through the Federal eRulemaking portal collected; and 0095] (regulations.gov) or by U.S. mail to the 4. Minimize the burden of the address listed above. collection of information on those who Proposed Data Collection Submitted FOR FURTHER INFORMATION CONTACT: To are to respond, including through the for Public Comment and request more information on the use of appropriate automated, Recommendations proposed project or to obtain a copy of electronic, mechanical, or other AGENCY: Centers for Disease Control and the information collection plan and technological collection techniques or Prevention (CDC), Department of Health instruments, contact Leroy A. other forms of information technology, and Human Services (HHS). Richardson, Information Collection e.g., permitting electronic submissions of responses. ACTION: Notice with comment period. Review Office, Centers for Disease Control and Prevention, 1600 Clifton 5. Assess information collection costs. SUMMARY: The Centers for Disease Road NE., MS–D74, Atlanta, Georgia Proposed Project Control and Prevention (CDC), as part of 30329; phone: 404–639–7570; Email: its continuing efforts to reduce public [email protected]. Evaluation of the Cancer Survivorship Demonstration Project—New—National burden and maximize the utility of SUPPLEMENTARY INFORMATION: government information, invites the Center for Chronic Disease Prevention Under the Paperwork Reduction Act general public and other Federal and Health Promotion (NCCDPHP), of 1995 (PRA) (44 U.S.C. 3501–3520), agencies to take this opportunity to Centers for Disease Control and Federal agencies must obtain approval comment on proposed work and/or Prevention (CDC). from the Office of Management and continuing information collections, as Budget (OMB) for each collection of Background and Brief Description required by the Paperwork Reduction information they conduct or sponsor. In Under CDC’s National Comprehensive Act of 1995. This notice invites addition, the PRA also requires Federal Cancer Control Program (NCCCP) comment on the Evaluation of the agencies to provide a 60-day notice in Request for Applications DP5–1501, the Cancer Survivorship Demonstration the Federal Register concerning each Division of Cancer Prevention and Project. This information collection proposed collection of information, Control (DCPC) funded six grantees to aims to help CDC better understand including each new proposed implement evidence-based and strategies and best practices to identify collection, each proposed extension of promising strategies to increase and address current cancer survivorship existing collection of information, and knowledge of cancer survivor needs, needs and gaps. each reinstatement of previously increase survivor knowledge of DATES: CDC must receive written approved information collection before treatment and follow-up care, and comments on or before January 12, submitting the collection to the OMB for increase provider knowledge of 2018. approval. To comply with this guidelines pertaining to treatment of ADDRESSES: You may submit comments, requirement, we are publishing this cancer. Specifically, this initiative identified by Docket No. CDC–2017– notice of a proposed data collection as employs strategies that relate to 0095 by any of the following methods: described below. increasing surveillance and community-
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clinical linkages. Through this identified key partners (e.g., coalition CDC intends to also seek OMB initiative, DCPC intends to help address members, providers, patient navigators), approval to conduct semi-structured the public health needs of cancer and semi-structured telephone interviews by telephone with a survivors. To facilitate evidence- interviews with NCCCP DP15–1501 purposive sample of one program informed policymaking and quality grantee program directors and program director and one program manager for improvement of federal programs, CDC managers. The data from the survey and each of the six grantee sites (12 needs a comprehensive evaluation to semi-structured interviews will provide respondents total). CDC will conduct characterize survivorship interventions additional insight into program efforts. the semi-structured interviews with the and document outcomes. CDC is requesting OMB approval to same respondents at two time points for CDC seeks to request OMB approval conduct a Web-based Grantee survey a total estimated burden of 36 hours. to collect information needed for this using Survey Gizmo to a purposive CDC will ask the respondents to evaluation. The proposed information sample of one program director and one provide information on the following: collection will focus on how each program manager for each of the six (1) Administration of the Behavioral grantee has expanded their knowledge grantee sites (12 respondents total) and Risk Factor Surveillance System Cancer of cancer survivor needs, increased to conduct a Web-based Partner Survey Survivorship Module; (2) utilization of surveillance data to inform of 10 self-identified key partners in each communication, education, and training program planning by providers and of 6 grantees for a total of 60 activities to support the implementation coalition members, and enhanced respondents. CDC will administer the of cancer survivorship interventions; (3) partnerships to facilitate and broaden Web-based surveys to the same community clinical linkage strategies to program reach. CDC will also collect respondents at two time points for a support cancer survivors, knowledge data on challenges encountered and addressed, factors that facilitated total estimated burden of 8 hours for the regarding best practices for survivorship implementation, and lessons learned Web-based Grantee Survey and 40 hours care; partnership engagement; (4) along the way. The requested for the Web-based Partner Survey. dissemination of evidence-based information does not currently exist for CDC will ask the respondents to survivorship interventions; and (5) organizations and entities working to provide information regarding the type recommendations for improving the improve cancer survivorship needs. of respondent; their use of surveillance implementation of evidence-based With this data, CDC will gain critical data to inform survivorship survivorship interventions. insights for improving achieving interventions; communication, CDC will analyze the collected immediate strategic efforts and goals to education, and training activities to information and use in aggregate to improve the public health needs of support the implementation of inform future efforts to support cancer cancer survivors. survivorship interventions; partnership survivors and to initiate evidence- CDC plans to collect information engagement; challenges and facilitators informed program decisions when during two cycles of the program using regarding the implementation of rolling this initiative out to all NCCCP a Web-based Grantee survey of NCCCP evidence-based cancer survivorship grantees. Without this data collection, DP15–1501 grantee program directors strategies; reach of cancer survivorship CDC will not be able to provide tailored and program managers, a Web-based interventions; and respondent technical assistance to its grantees and Partner Survey of grantees’ self- background information. communicate program efforts.
ESTIMATED ANNUALIZED BURDEN HOURS
Average Number of Number of burden per Total burden Type of respondent Form name respondents responses per response (in hours) respondent (in hours)
NCCCP Grantee Program Director .. Web-based Grantee survey ...... 12 2 20/60 8 Semi-structured telephone interview 12 2 1.50 36 NCCCP Grantee Partner ...... Web-based Partner survey ...... 60 2 20/60 40
Total ...... 84
Leroy A. Richardson, DEPARTMENT OF HEALTH AND SUMMARY: The Centers for Disease Chief, Information Collection Review Office, HUMAN SERVICES Control and Prevention (CDC), as part of Office of Scientific Integrity, Office of the its continuing effort to reduce public Associate Director for Science, Office of the Centers for Disease Control and burden and maximize the utility of Director, Centers for Disease Control and Prevention government information, invites the Prevention. general public and other Federal [FR Doc. 2017–24523 Filed 11–9–17; 8:45 am] [60Day–17–17AUZ; Docket No. CDC–2017– agencies to take this opportunity to BILLING CODE 4163–18–P 0065] comment on proposed and/or continuing information collections, as Proposed Data Collection Submitted required by the Paperwork Reduction for Public Comment and Act of 1995. This notice invites Recommendations comment on ‘‘Project NICE: Navigating AGENCY: Centers for Disease Control and Insurance Coverage Expansion’’. Project Prevention (CDC), Department of Health NICE will evaluate the efficacy of an in- and Human Services (HHS). person health insurance enrollment assistance intervention among Black ACTION: Notice with comment period. and Hispanic men who have sex with
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men (MSM) and Transgender persons including the validity of the insurance enrollment assistance, from living in the Chicago, Illinois methodology and assumptions used; the first clinic visit after receipt of an metropolitan area. 3. Enhance the quality, utility, and HIV test result, to earlier in the care DATES: CDC must receive written clarity of the information to be continuum, during the HIV testing comments on or before January 12, collected; and event, will impact health outcomes. 2018. 4. Minimize the burden of the Therefore, this study does not introduce collection of information on those who new intervention activities or burden on ADDRESSES: You may submit comments, are to respond, including through the the participants or the agency staff; it identified by Docket No. CDC–2017– use of appropriate automated, reorders the sequence of delivery of 0065 by any of the following methods: electronic, mechanical, or other • Federal eRulemaking Portal: standard practice. Only the addition of technological collection techniques or Regulations.gov. Follow the instructions data collection forms and procedures other forms of information technology, for submitting comments. will be new, and the additional burden e.g., permitting electronic submissions • Mail: Leroy A. Richardson, will be to partner agency staff workload of responses. Information Collection Review Office, and participant experience. 5. Assess information collection costs. Centers for Disease Control and In 2013, MSM accounted for 81% of Prevention, 1600 Clifton Road NE., MS– Proposed Project new HIV infections among males and 65% of all new HIV infections. In 2010, D74, Atlanta, Georgia 30329. Project NICE: Navigating Insurance health officials reported 10,600 new HIV Instructions: All submissions received Coverage Expansion—New—National infections for African-American (Black) must include the agency name and Center for HIV/AIDS, Viral Hepatitis, MSM, 11,200 for White MSM, and 6,700 Docket Number. CDC will post, without STD, and TB Prevention (NCHHSTP), for Hispanic MSM. Through a 2008 change, all relevant comments to Centers for Disease Control and systematic review, researchers found Regulations.gov. Prevention (CDC). Please note: Submit all comments HIV rates among Black and Hispanic through the Federal eRulemaking portal Background and Brief Description Transgender women to be 56% and (regulations.gov) or by U.S. mail to the CDC seeks to request a three-year 16%, respectively. address listed above. OMB approval to evaluate the efficacy Black and Hispanic MSM and FOR FURTHER INFORMATION CONTACT: To of an in-person health insurance Transgender persons face obstacles in request more information on the enrollment assistance intervention seeking medical care and following proposed project or to obtain a copy of among 1,000 Black and Hispanic MSM through with referrals or appointments, the information collection plan and and Transgender persons ages ≥18 years including lack of health insurance. instruments, contact Leroy A. living in the Chicago, Illinois This study will implement a Richardson, Information Collection metropolitan area. CDC will invite structural intervention. The goal of this Review Office, Centers for Disease individuals attending HIV testing study is to test whether providing in- Control and Prevention, 1600 Clifton outreach events, or seeking care in person assistance for first-time private Road NE., MS–D74, Atlanta, Georgia select clinics in Chicago to participate health insurance or Medicaid 30329; phone: 404–639–7570; Email: in the study after an HIV testing session. enrollment, changing to a different [email protected]. Researchers will collect study insurance plan, or understanding how SUPPLEMENTARY INFORMATION: Under the participants’ sociodemographic, risk to use current insurance policies Paperwork Reduction Act of 1995 (PRA) behavior, and insurance coverage following HIV testing will: (1) Increase (44 U.S.C. 3501–3520), Federal agencies information as part of study enrollment. the proportion of participants who must obtain approval from the Office of Each quarter, researchers will abstract obtain health insurance; (2) result in Management and Budget (OMB) for each outcome evaluation data (linkage to and better health outcomes among collection of information they conduct retention in HIV-related care, referrals participants (e.g., achieving viral or sponsor. In addition, the PRA also for mental health or substance use, and suppression, remaining HIV negative); requires Federal agencies to provide a other health outcomes) from study (3) improve the linkage and retention 60-day notice in the Federal Register participant’s electronic medical records rates for HIV care (i.e., HIV treatment, concerning each proposed collection of (EMRs). Researchers will also assess Pre-exposure Prophylaxis (PrEP)) and information, including each new intervention cost-effectiveness. other HIV-associated health services proposed collection, each proposed CDC funded this study through a (e.g., mental health counseling, extension of existing collection of cooperative agreement with the substance use treatment) of participants, information, and each reinstatement of University of Chicago Medicine (UCM). especially those diagnosed with HIV; previously approved information Three partner agencies will conduct the and (4) increase HIV care linkage and collection before submitting the intervention: (1) University of Chicago retention rates sufficiently to justify the collection to the OMB for approval. To Medicine (UCM) (the lead partner cost of implementing the intervention comply with this requirement, we are agency), (2) Howard Brown Health, and (cost-benefit analysis) among Black and publishing this notice of a proposed (3) Chicago House and Social Service Hispanic MSM and Transgender data collection as described below. Agency (Chicago House). The three persons age 18 or older in the Chicago, The OMB is particularly interested in partner agencies each have a history of Illinois metropolitan area. comments that will help: providing clinical care, HIV testing Randomized controlled trials (RCTs) 1. Evaluate whether the proposed outreach, and in-person health of structural interventions are rare. collection of information is necessary insurance enrollment assistance for Nevertheless, CDC will use a RCT for the proper performance of the Chicago’s MSM and Transgender design to enhance scientific validity and functions of the agency, including communities. the policy impact of the intervention, whether the information will have As part of this study, CDC will and help researchers assess the efficacy practical utility; evaluate the in-person health insurance of this intervention as an emerging 2. Evaluate the accuracy of the enrollment assistance. Specifically, practice prior to dissemination to HIV agency’s estimate of the burden of the researchers will evaluate whether prevention service providers proposed collection of information, moving the delivery of in-person health nationwide.
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This project aligns with National HIV/ The study will enroll 1,000 If eligible and interested in AIDS Strategy 2020 and Health People participants over 12 months to reach participating, individuals will complete 2020 objectives. This structural adequate power calculations (500 into the Participant Enrollment Form, which intervention aligns with the OMB’s the intervention arm, and 500 into the will take approximately 35 minutes to emphasis on application of behavioral control arm). complete. Researchers then will offer in- insights in that it restructures the After an HIV testing session at an person health insurance enrollment to context (i.e., after HIV testing) in which outreach event or clinic visit, a partner- randomized intervention arm health-related decision-making (i.e., agency staff person will invite an participants. This enrollment will take a individual to participate in the study. If health insurance enrollment) occurs in maximum of 60 minutes to complete. interested, participants will complete a order to promote the selection of The study’s in-person health insurance consent form. Staff will screen enrollment assistance will take the same beneficial options. The proposed health individuals using the Eligibility Form, insurance enrollment assistance project which will take approximately five amount of time as standard practice has the potential for widespread health minutes to complete. Researchers would health insurance enrollment assistance. improvements for Black and Hispanic need to screen approximately 1,500 The total estimated annualized hourly MSM and Transgender persons individuals in order to identify and burden anticipated for this study is regardless of their HIV status. enroll 1,000 eligible study participants. 1,458 hours.
ESTIMATED ANNUALIZED BURDEN HOURS
Average Number of Number of burden per Total burden Type of respondent Form name respondents responses per response hours respondent (in hours)
Study participant ...... Consent Form ...... 1,500 1 10/60 250 Study participant ...... Eligibility Form ...... 1,500 1 5/60 125 Study participant ...... Participant Enrollment Form ...... 1,000 1 35/60 583 Study participant (Intervention arm ACTIVITY: In-person health insur- 500 1 1 500 ONLY). ance enrollment assistance.
Total ...... 1,458
Leroy A. Richardson, collection of information) and to allow Division of Regulations Development, Chief, Information Collection Review Office, 60 days for public comment on the Attention: Document Identifier/OMB Office of Scientific Integrity, Office of the proposed action. Interested persons are Control Number __, Room C4–26–05, Associate Director for Science, Office of the invited to send comments regarding our 7500 Security Boulevard, Baltimore, Director, Centers for Disease Control and burden estimates or any other aspect of Maryland 21244–1850. Prevention. this collection of information, including To obtain copies of a supporting [FR Doc. 2017–24473 Filed 11–9–17; 8:45 am] the necessity and utility of the proposed statement and any related forms for the BILLING CODE 4163–18–P information collection for the proper proposed collection(s) summarized in performance of the agency’s functions, this notice, you may make your request the accuracy of the estimated burden, using one of following: DEPARTMENT OF HEALTH AND ways to enhance the quality, utility, and 1. Access CMS’ Web site address at HUMAN SERVICES clarity of the information to be http://www.cms.hhs.gov/ collected, and the use of automated PaperworkReductionActof1995. Centers for Medicare & Medicaid collection techniques or other forms of 2. Email your request, including your Services information technology to minimize the address, phone number, OMB number, [Document Identifiers: CMS–R–48 and information collection burden. and CMS document identifier, to CMS–10421] DATES: Comments must be received by [email protected]. January 12, 2018. 3. Call the Reports Clearance Office at Agency Information Collection ADDRESSES: When commenting, please (410) 786–1326. Activities: Proposed Collection; FOR FURTHER INFORMATION CONTACT: Comment Request reference the document identifier or OMB control number. To be assured William Parham at (410) 786–4669. AGENCY: Centers for Medicare & consideration, comments and SUPPLEMENTARY INFORMATION: Medicaid Services, HHS. recommendations must be submitted in Contents ACTION: Notice. any one of the following ways: 1. Electronically. You may send your This notice sets out a summary of the SUMMARY: The Centers for Medicare & comments electronically to http:// use and burden associated with the Medicaid Services (CMS) is announcing www.regulations.gov. Follow the following information collections. More an opportunity for the public to instructions for ‘‘Comment or detailed information can be found in comment on CMS’ intention to collect Submission’’ or ‘‘More Search Options’’ each collection’s supporting statement information from the public. Under the to find the information collection and associated materials (see Paperwork Reduction Act of 1995 (the document(s) that are accepting ADDRESSES). PRA), federal agencies are required to comments. CMS–R–48 Hospital Conditions of publish notice in the Federal Register 2. By regular mail. You may mail Participation and Supporting concerning each proposed collection of written comments to the following Regulations information (including each proposed address: CMS, Office of Strategic CMS–10421 Fee-for-Service Recovery extension or reinstatement of an existing Operations and Regulatory Affairs, Audit Prepayment Review
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Demonstration and Prior Frequency: Yearly; Affected Public: Form Number: CMS–10421 (OMB Authorization Demonstration Private sector (Business or other for- control number: 0938–1169); Frequency: Under the PRA (44 U.S.C. 3501– profit); Number of Respondents: 4,991; Occasionally; Affected Public: State, 3520), federal agencies must obtain Total Annual Responses: 1,342,424; Local or Tribal Governments; Number of approval from the Office of Management Total Annual Hours: 18,840,617. (For Respondents: 50,500; Total Annual and Budget (OMB) for each collection of policy questions regarding this Responses: 50,500; Total Annual Hours: information they conduct or sponsor. collection contact Scott Cooper at 410– 25,125. (For policy questions regarding The term ‘‘collection of information’’ is 786–9465.) this collection contact Daniel Schwartz defined in 44 U.S.C. 3502(3) and 5 CFR 2. Type of Information Collection at 410–786–4197.) Request: Extension of a currently 1320.3(c) and includes agency requests Dated: November 7, 2017. or requirements that members of the approved collection; Title of Information Collection: Fee-for-Service Martique Jones, public submit reports, keep records, or Director, Regulations Development Group, provide information to a third party. Recovery Audit Prepayment Review Demonstration and Prior Authorization Office of Strategic Operations and Regulatory Section 3506(c)(2)(A) of the PRA Affairs. Demonstration; Use: OMB approved the requires federal agencies to publish a collections required for two [FR Doc. 2017–24524 Filed 11–9–17; 8:45 am] 60-day notice in the Federal Register demonstrations of prepayment review BILLING CODE 4120–01–P concerning each proposed collection of and prior authorization. The first information, including each proposed demonstration allows Medicare extension or reinstatement of an existing Recovery Auditors to review claims on DEPARTMENT OF HEALTH AND collection of information, before a pre-payment basis in certain States. HUMAN SERVICES submitting the collection to OMB for The second demonstration established a approval. To comply with this Administration for Community Living prior authorization program for Power requirement, CMS is publishing this Mobility Device claims in certain States. notice. Agency Information Collection The first demonstration has ended, so Activities; Proposed Collection; Public Information Collection we are only extending the collection of Comment Request; Semiannual information for the second 1. Type of Information Collection Performance Measures for the ACL demonstration, prior authorization of Request: Reinstatement without change Traumatic Brain Injury State power mobility devices. Partnership Program (ICR New) of a previously approved collection; For the Prior Authorization of Power Title of Information Collection: Hospital Mobility Devices (PMDs) AGENCY: Administration for Community Conditions of Participation and Demonstration, we are piloting prior Living, HHS. Supporting Regulations; Use: The authorization for PMDs. Prior ACTION: Notice. information collection requirements authorization will allow the applicable described in this information collection documentation that supports a claim to SUMMARY: The Administration for request are needed to implement the be submitted before the item is Community Living (ACL) is announcing Medicare and Medicaid conditions of delivered. For prior authorization, an opportunity for the public to participation (CoP) for 4,890 accredited relevant documentation for review is comment on the proposed collection of and non-accredited hospitals and an submitted before the item is delivered or certain information by the agency. additional 101 critical access hospitals the service is rendered. CMS will Under the Paperwork Reduction Act of (CAHs) that have distinct part conduct this demonstration in 1995 (PRA), federal agencies are psychiatric or rehabilitation units California, Florida, Illinois, Michigan, required to publish a notice in the (DPUs). CAHs that have DPUs must New York, North Carolina, Texas, Federal Register concerning each comply with all of the hospital CoPs on Pennsylvania, Ohio, Louisiana, proposed collection of information, these units. Thus, this package reflects Missouri, Maryland, New Jersey, including each proposed extension of an the burden for a total of 4,991 hospitals Indiana, Kentucky, Georgia, Tennessee, existing collection of information, and (that is, 4,890 accredited/non-accredited Washington, and Arizona based on to allow 60 days for public comment in hospitals and 101 CAHs which include beneficiary address as reported to the response to the notice. 81 CAHs that have psychiatric DPUs Social Security Administration and This notice solicits comments on and 20 CAHs that have rehabilitation recorded in the Common Working File proposed semiannual performance DPUs). The information collection (CWF). For the demonstration, a prior measures for the ACL Traumatic Brain requirements for the remaining 1,183 authorization request can be completed Injury State Partnership program as CAHs have been approved in a separate by the (ordering) physician or treating reauthorized under the Traumatic Brain package under CMS–10239 (OMB practitioner and submitted to the Injury Reauthorization Act of 2014. control number: 0938–1043). appropriate Durable Medical Equipment DATES: Submit written or electronic The CoPs and accompanying Medicare Administrative Contractor comments on the collection of regulatory requirements are used by our (DME MAC) for an initial decision. The information by January 12, 2018. surveyors as a basis for determining supplier may also submit the request on whether a hospital qualifies for a behalf of the physician or treating ADDRESSES: Submit electronic provider agreement under Medicare and practitioner. The physician, treating comments on the collection of Medicaid. CMS and the health care practitioner or supplier who submits the information to: [email protected]. Submit industry believe that the availability to request on behalf of the physician or written comments to: U.S. Department the facility of the type of records and treating practitioner, is referred to as the of Health and Human Services, general content of records is standard ‘‘submitter.’’ Under this demonstration, Administration for Community Living, medical practice and is necessary to the submitter will submit to the DME Washington, DC 20201, Attention: ensure the well-being and safety of MAC a request for prior authorization Thom Campbell. patients and professional treatment and all relevant documentation to FOR FURTHER INFORMATION CONTACT: accountability. Form Number: CMS–R– support Medicare coverage of the PMD Thom Campbell by telephone: (202) 48 (OMB control number: 0938–0328); item. 795–7263 or by email: [email protected].
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SUPPLEMENTARY INFORMATION: Under the on respondents, including through the information about the number and types PRA (44 U.S.C. 3501–3520), federal use of automated collection techniques of individuals who receive TBI-related agencies must obtain approval from the when appropriate and other forms of home and community based services. Office of Management and Budget information technology. Finally, ACL seeks information (OMB) for each collection of regarding the involvement of people Purpose information they conduct or sponsor. with TBI in advisory and program ‘‘Collection of information’’ is defined The purpose of the Traumatic Brain support roles. in 44 U.S.C. 3502(3) and 5 CFR Injury (TBI) State Partnership program The data collected will allow ACL to 1320.3(c) and includes agency requests is to increase access to rehabilitation determine the extent to which the grant or requirements that members of the and other services for individuals with program is meeting its goals of public submit reports, keep records, or traumatic brain injury. Under the expanding and improving services, provide information to a third party. Traumatic Brain Injury Reauthorization generating sustainable funding streams, Section 3506(c)(2)(A) of the PRA (44 Act of 2014 (Pub. L. 113–196), the and enriching service systems to better U.S.C. 3506(c)(2)(A)) requires federal Traumatic Brain Injury State serve individuals with TBI and their agencies to provide a 60-day notice in Partnership program transitioned from families. The data will also help ACL the Federal Register concerning each the Health Resources and Services develop and expand baseline proposed collection of information Administration (HRSA) to the information around the nature and before submitting the collection to OMB Administration for Community Living scope of the incidence of TBI. for approval. (ACL). Under this law, the Secretary, Additionally, this data collection will To comply with the above acting through ACL, was authorized to help ACL illustrate the return on requirement, ACL is publishing a notice ‘‘make grants to States and American investment of the TBI funds in terms of of a new collection of information as set Indian consortia for the purpose of system change (i.e., changes in policies forth in this document. With respect to carrying out projects to improve access and practices and the development of the following collection of information, to rehabilitation and other services networks). By matching the project ACL invites comments on: (1) Whether regarding traumatic brain injury.’’ ACL dollars spent against measurable the proposed collection of information seeks to collect performance measure improvements in state systems for is necessary for the proper performance data from state grantees consistent with delivering services and supports to of ACL’s functions, including whether the TBI State Partnership program’s people living with TBI, ACL will have the information will have practical purpose and ACL’s mission to a strong indicator of the effect of the TBI utility and/or help ACL illustrate the ‘‘Maximize the independence, well- program on the quality of services program’s return on investment; (2) the being, and health of older adults, people which ultimately impact the lives of accuracy of ACL’s estimate of the with disabilities across the lifespan, and people across the country living with burden of the proposed collection of their families and caregivers.’’ TBI. The proposed data collection forms information, including the validity of ACL seeks data on a semi-annual may be found on the ACL Web site for the methodology and assumptions used; basis on the types of practices, review at: https://www.acl.gov/about- (3) ways to enhance the quality, utility, protocols, and activities performed by acl/public-input. and clarity of the information to be each grantee, as well as the cost of each Estimated Program Burden: The collected; and (4) ways to minimize the activity and the number and types of annual reporting burden estimates are burden of the collection of information people they served. ACL also seeks shown below.
Average Number of Number of burden per Total Type of respondent Form name respondents responses per response burden hours respondent (in hours)
States ...... State Performance Report ...... * 45 2 16 1,440 * This is the highest number of awards anticipated, but it is possible that there will be less. If less than 45 grants are awarded, the total burden hours will be adjusted proportionally.
Dated: November 7, 2017. DEPARTMENT OF HEALTH AND guidance entitled ‘‘S5(R3) Detection of Mary Lazare, HUMAN SERVICES Toxicity to Reproduction for Human Principal Deputy Administrator. Pharmaceuticals.’’ The draft guidance Food and Drug Administration [FR Doc. 2017–24525 Filed 11–9–17; 8:45 am] was prepared under the auspices of the International Council for Harmonisation BILLING CODE 4154–01–P [Docket No. FDA–2017–D–5138] (ICH), formerly the International Conference on Harmonisation. The draft S5(R3) Detection of Toxicity to guidance replaces the existing guidance Reproduction for Human entitled ‘‘S5(R2) Detection of Toxicity to Pharmaceuticals; International Council Reproduction for Human for Harmonisation; Draft Guidance for Pharmaceuticals.’’ The draft guidance is Industry; Availability intended to align with other ICH AGENCY: Food and Drug Administration, guidances, elaborate on concepts to HHS. consider when designing studies, and ACTION: Notice of availability. identify potential circumstances in which a risk assessment can be made SUMMARY: The Food and Drug based on preliminary studies. It also Administration (FDA or Agency) is clarifies the qualification and potential announcing the availability of a draft use of alternative assays.
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DATES: Although you can comment on https://www.regulations.gov or at the obtained by mail by calling CBER at 1– any guidance at any time (see 21 CFR Dockets Management Staff Office 800–835–4709 or 240–402–8010. See 10.115 (g)(5)), to ensure that the Agency between 9 a.m. and 4 p.m., Monday the SUPPLEMENTARY INFORMATION section considers your comment on this draft through Friday. for electronic access to the draft guidance before it begins work on the • Confidential Submissions—To guidance document. final version of the guidance, submit submit a comment with confidential FOR FURTHER INFORMATION CONTACT: either electronic or written comments information that you do not wish to be Regarding the guidance: Abigail Jacobs, on the draft guidance by February 12, made publicly available, submit your Center for Drug Evaluation and 2018. comments only as a written/paper Research, Food and Drug submission. You should submit two ADDRESSES: Administration, 10903 New Hampshire You may submit comments copies total. One copy will include the as follows: Ave., Bldg. 22, Rm. 6474, Silver Spring, information you claim to be confidential MD 20993–0002, 301–796–0174; or Electronic Submissions with a heading or cover note that states Martin (Dave) Green, Center for ‘‘THIS DOCUMENT CONTAINS Submit electronic comments in the Biologics Evaluation and Research, CONFIDENTIAL INFORMATION.’’ The following way: Food and Drug Administration, 10903 Agency will review this copy, including • Federal eRulemaking Portal: New Hampshire Ave., Bldg. 71, Rm. the claimed confidential information, in https://www.regulations.gov. Follow the 3270, Silver Spring, MD 20993–0002, its consideration of comments. The instructions for submitting comments. 301–796–2640. Regarding the ICH: second copy, which will have the Amanda Roache, Center for Drug Comments submitted electronically, claimed confidential information including attachments, to https:// Evaluation and Research, Food and redacted/blacked out, will be available Drug Administration, 10903 New www.regulations.gov will be posted to for public viewing and posted on Hampshire Ave., Bldg. 51, Rm. 1176, the docket unchanged. Because your https://www.regulations.gov. Submit Silver Spring, MD 20993–0002, 301– comment will be made public, you are both copies to the Dockets Management 796–4548. solely responsible for ensuring that your Staff Office. If you do not wish your comment does not include any name and contact information to be SUPPLEMENTARY INFORMATION: confidential information that you or a made publicly available, you can I. Background third party may not wish to be posted, provide this information on the cover such as medical information, your or sheet and not in the body of your FDA is announcing the availability of anyone else’s Social Security number, or comments and you must identify this a draft guidance for industry entitled confidential business information, such information as ‘‘confidential.’’ Any ‘‘S5(R3) Detection of Toxicity to as a manufacturing process. Please note information marked as ‘‘confidential’’ Reproduction for Human that if you include your name, contact will not be disclosed except in Pharmaceuticals.’’ In recent years, information, or other information that accordance with 21 CFR 10.20 and other regulatory authorities and industry identifies you in the body of your applicable disclosure law. For more associations have participated in many comments, that information will be information about FDA’s posting of important initiatives to promote posted on https://www.regulations.gov. comments to public dockets, see 80 FR international harmonization of • If you want to submit a comment 56469, September 18, 2015, or access regulatory requirements. FDA has with confidential information that you the information at: https://www.gpo.gov/ participated in several meetings do not wish to be made available to the fdsys/pkg/FR-2015-09-18/pdf/2015- designed to enhance harmonization and public, submit the comment as a 23389.pdf. is committed to seeking scientifically written/paper submission and in the Docket: For access to the docket to based, harmonized technical procedures manner detailed (see ‘‘Written/Paper read background documents or the for pharmaceutical development. One of Submissions’’ and ‘‘Instructions’’). electronic and written/paper comments the goals of harmonization is to identify and reduce differences in technical Written/Paper Submissions received, go to https:// www.regulations.gov and insert the requirements for drug development Submit written/paper submissions as docket number, found in brackets in the among regulatory agencies. follows: heading of this document, into the ICH was organized to provide an • Mail/Hand delivery/Courier (for ‘‘Search’’ box and follow the prompts opportunity for harmonization written/paper submissions): Dockets and/or go to the Dockets Management initiatives to be developed with input Management Staff (HFA–305), Food and Staff, 5630 Fishers Lane, Rm. 1061, from both regulatory and industry Drug Administration, 5630 Fishers Rockville, MD 20852. representatives. FDA also seeks input Lane, Rm. 1061, Rockville, MD 20852. Submit written requests for single from consumer representatives and • For written/paper comments copies of this draft guidance to the others. ICH is concerned with submitted to the Dockets Management Division of Drug Information, Center for harmonization of technical Staff Office, FDA will post your Drug Evaluation and Research (CDER), requirements for the registration of comment, as well as any attachments, Food and Drug Administration, 10001 pharmaceutical products for human use except for information submitted, New Hampshire Ave., Hillandale among regulators around the world. The marked and identified, as confidential, Building, 4th Floor, Silver Spring, MD six founding members of the ICH are the if submitted as detailed in 20993–0002, or the Office of European Commission; the European ‘‘Instructions.’’ Communication, Outreach and Federation of Pharmaceutical Industries Instructions: All submissions received Development, Center for Biologics Associations; the Japanese Ministry of must include the Docket No. FDA– Evaluation and Research (CBER), Food Health, Labour, and Welfare; the 2017–D–5138 for ‘‘S5(R3) Detection of and Drug Administration, 10903 New Japanese Pharmaceutical Manufacturers Toxicity to Reproduction for Human Hampshire Ave., Bldg. 71, Rm. 3128, Association; CDER and CBER, FDA; and Pharmaceuticals.’’ Received comments Silver Spring, MD 20993–0002. Send the Pharmaceutical Research and will be placed in the docket and, except one self-addressed adhesive label to Manufacturers of America. The for those submitted as ‘‘Confidential assist that office in processing your Standing Members of the ICH Submissions,’’ publicly viewable at requests. The guidance may also be Association include Health Canada and
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Swissmedic. Any party eligible to on ‘‘S5(R3) Detection of Toxicity to Officer, 14N39, 5600 Fishers Lane, become a member in accordance with Reproduction for Human Rockville, MD 20857. the ICH Articles of Association can Pharmaceuticals.’’ It does not establish FOR FURTHER INFORMATION CONTACT: To apply for membership in writing to the any rights for any person and is not request more information on the ICH Secretariat. The ICH Secretariat, binding on FDA or the public. You can proposed project or to obtain a copy of which coordinates the preparation of use an alternative approach if it satisfies the data collection plans and draft documentation, operates as an the requirements of the applicable instruments, email [email protected] international nonprofit organization and statutes and regulations. This guidance or call Lisa Wright-Solomon, the HRSA is funded by the members of the ICH is not subject to Executive Order 12866. Information Collection Clearance Officer Association. at (301) 443–1984. The ICH Assembly is the overarching II. Electronic Access SUPPLEMENTARY INFORMATION: When body of the Association and includes Persons with access to the internet submitting comments or requesting representatives from each of the ICH may obtain the draft guidance at https:// information, please include the members and observers. www.regulations.gov, https:// In August 2017, the ICH Assembly information request collection title for www.fda.gov/Drugs/ reference, in compliance with Section endorsed the draft guidance titled GuidanceCompliance ‘‘S5(R3) Detection of Toxicity to 3506(c)(2)(A) of the Paperwork RegulatoryInformation/Guidances/ Reduction Act of 1995. Reproduction for Human default.htm, or https://www.fda.gov/ Pharmaceuticals’’ and agreed that the Information Collection Request Title: BiologicsBloodVaccines/ Voluntary Partner Surveys to Implement guidance should be made available for GuidanceCompliance public comment. The draft guidance is Executive Order 12862 in the Health RegulatoryInformation/Guidances/ Resources and Services Administration the product of the S5(R3) Safety Expert default.htm. Working Group of the ICH. Comments OMB No. 0915–0212—Extension. about this draft will be considered by Dated: November 2, 2017. Abstract: In response to Executive FDA and the S5(R3) Safety Expert Anna K. Abram, Order 12862, HRSA is proposing to Working Group. Deputy Commissioner for Policy, Planning, conduct voluntary customer surveys of The draft guidance replaces the Legislation, and Analysis. its partners to assess strengths and existing guidance entitled ‘‘S5(R2) [FR Doc. 2017–24483 Filed 11–9–17; 8:45 am] weaknesses in program services and Detection of Toxicity to Reproduction BILLING CODE 4164–01–P processes. HRSA partners are typically for Human Pharmaceuticals.’’ The state or local governments, health care guidance has undergone major revisions facilities, health care consortia, health to align with other ICH guidances, DEPARTMENT OF HEALTH AND care providers, and researchers. HRSA elaborate on concepts to consider when HUMAN SERVICES is requesting continued approval for a designing studies, and identify potential generic clearance from OMB to conduct circumstances in which a risk Health Resources and Services the partner surveys. assessment can be made based on Administration Partner surveys to be conducted by preliminary studies. It also clarifies the HRSA might include, for example, mail Agency Information Collection qualification and potential use of or telephone surveys of grantees to Activities: Proposed Collection: Public alternative assays. determine satisfaction with grant To support using alternative assays, Comment Request; Information processes or technical assistance compounds that are either positive or Collection Request Title: Voluntary provided by a contractor, or in-class negative in their ability to induce Partner Surveys To Implement evaluation forms completed by embryolethality or malformations are Executive Order 12862 in the Health providers who receive training from used in the process of qualifying the Resources and Services HRSA grantees to measure satisfaction assays. Although a number of Administration, OMB No. 0915–0212— with the training experience. HRSA will compounds have been identified in the Extension use the results of these surveys to plan draft guidance’s Annex, section 11.3.4, AGENCY: Health Resources and Services and redirect resources and efforts as Tables 9–6 and 9–7, with the type of Administration (HRSA), Department of needed to improve services and information for the compounds, the list Health and Human Services. processes. is not complete; therefore, FDA is HRSA may also use focus groups to requesting data in the form of public ACTION: Notice. gain partner input into the design of comments to the docket for additional mail and telephone surveys. Focus SUMMARY: In compliance with the groups, in-class evaluation forms, mail positive and negative reference requirement for opportunity for public surveys, and telephone surveys are compounds for potential inclusion into comment on proposed data collection expected to be the preferred data the list. These compounds can be either projects of the Paperwork Reduction Act collection methods. pharmaceuticals or non- of 1995, HRSA announces plans to A generic approval allows HRSA to pharmaceuticals and should be submit an Information Collection conduct a limited number of partner commercially available. For additional Request (ICR), described below, to the surveys without a full-scale OMB guidance, please refer to Endnote 3 in Office of Management and Budget review of each survey. If this request the S5(R3) guidance. This is not a (OMB). Prior to submitting the ICR to receives continued approval, request for data for the compounds OMB, HRSA seeks comments from the information on each individual partner already listed in Table 9–6, nor is this public regarding the burden estimate, survey will not be published in the a request for examples of assays that below, or any other aspect of the ICR. could be used. Federal Register. This draft guidance is being issued DATES: Comments on this ICR must be Burden Statement: Burden in this consistent with FDA’s good guidance received no later than January 12, 2018. context means the time expended by practices regulation (21 CFR 10.115). ADDRESSES: Submit your comments to persons to generate, maintain, retain, The draft guidance, when finalized, will [email protected] or mail the HRSA disclose or provide the information represent the current thinking of FDA Information Collection Clearance requested. This includes the time
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needed to review instructions; to maintaining information, and disclosing the collection of information; and to develop, acquire, install and utilize and providing information; to train transmit or otherwise disclose the technology and systems for the purpose personnel and to be able to respond to information. The total annual burden of collecting, validating and verifying a collection of information; to search hours estimated for this ICR are information, processing and data sources; to complete and review summarized in the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Average Number of Number of Total burden per Total burden Form name respondents responses per responses response hours respondent (in hours)
In-class evaluations ...... 40,000 1 40,000 .05 2,000 Mail/Telephone surveys ...... 12,000 1 12,000 .25 3,000 Focus groups ...... 250 1 250 1.5 375
Total ...... 52,250 ...... 52,250 ...... 5,375
HRSA specifically requests comments DATES: Comments on this ICR should be treatment for HIV has been shown to on (1) the necessity and utility of the received no later than December 13, greatly reduce associated morbidity and proposed information collection for the 2017. mortality, and prevents transmission of proper performance of the agency’s ADDRESSES: Submit your comments, HIV. In spite of the known benefit of functions, (2) the accuracy of the including the ICR Title, to the desk treatment, many individuals remain out estimated burden, (3) ways to enhance officer for HRSA, either by email to of care or access care only the quality, utility, and clarity of the [email protected] or by intermittently; the CDC estimated that information to be collected, and (4) the fax to 202–395–5806. in 2013, approximately 45 percent of use of automated collection techniques people living with HIV (PLWH) in the FOR FURTHER INFORMATION CONTACT: To or other forms of information United States were not virally request a copy of the clearance requests technology to minimize the information suppressed, indicating a significant gap submitted to OMB for review, email Lisa collection burden. in the percentage of PLWH who are Wright-Solomon, the HRSA Information being successfully engaged and retained Amy McNulty, Collection Clearance Officer at in care. In spite of the increased Acting Director, Division of the Executive [email protected] or call (301) 443– attention on retention in care and the Secretariat. 1984. overarching goal of viral suppression, [FR Doc. 2017–24492 Filed 11–9–17; 8:45 am] SUPPLEMENTARY INFORMATION: little data exist regarding the specific BILLING CODE 4165–15–P Information Collection Request Title: individual factors that are associated Assessing Client Factors Associated with sub-optimal viral suppression. with Detectable HIV Viral Loads and Such information is valuable for DEPARTMENT OF HEALTH AND Models of Care and the Ryan White targeting programs to reach populations HUMAN SERVICES HIV/AIDS Program. that are currently not achieving HIV OMB No.: 0906–xxxx—NEW. viral suppression. Health Resources and Services Abstract: The Ryan White HIV/AIDS The second evaluation study, Models Administration Program (RWHAP), first authorized by of Care and the Ryan White HIV/AIDS the U.S. Congress in 1990, is Agency Information Collection Program, seeks to answer the critical administered by HRSA’s HIV/AIDS Activities: Submission to OMB for questions of what individual and Bureau (HAB). The RWHAP provides Review and Approval; Public Comment system-wide factors, including the medical services, treatment, and/or Request; Assessing Client Factors models of care employed among support services to 533,036 clients in RWHAP provider sites, contribute to Associated With Detectable HIV Viral 2015; 97.0 percent of these clients were better health outcomes for PLWH. While Loads; and Models of Care and the living with HIV. This information advances in treatment have improved Ryan White HIV/AIDS Program collection request covers two distinct survival in patients with HIV, longer evaluation studies with RWHAP lives are associated with increased AGENCY: Health Resources and Services provider sites that will share Administration (HRSA), Department of prevalence of adverse effects of HIV components of data collection infection and therapeutic complications, Health and Human Services. instruments through shared variables. concurrent with medical conditions ACTION: Notice. Sharing data collection instruments will related to aging processes that would minimize burden for RWHAP provider occur in the absence of HIV. These long- SUMMARY: In compliance with the sites collecting this data and will term complications amplify chronic Paperwork Reduction Act of 1995, increase the sample size for data disease management as a major issue for HRSA has submitted an Information analysis thus resulting in more robust the HIV population and a challenge for Collection Request (ICR) to the Office of data and greater generalizability of the delivery of effective health care. Yet Management and Budget (OMB) for results. little is known about how the method of review and approval. Comments The first evaluation study, Assessing health services delivery (the ‘‘model of submitted during the first public review Client Factors Associated with care’’) contributes to better health of this ICR will be provided to OMB. Detectable HIV Viral Loads, will explore outcomes, including HIV-related OMB will accept further comments from individuals’ specific facilitators and outcomes. For example, does it make a the public during the review and barriers to achieving and sustaining difference if a patient receives HIV care approval period. viral suppression. Early and effective from a primary care provider, a
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specialist, or from a care team that undetectable viral load as compared to • RWHAP client semi-structured includes both? Understanding the most the characteristics that are associated interviews (HIV Viral Suppression study effective models of care is important for with sub-optimal viral suppression. sites only)—Clients with detectable and HIV specialists, primary care This study will enable the development undetectable viral load. physicians, and other clinicians who of better targeted services for improved These studies will build upon and care for PLWH as they design and viral suppression rates. The Models of complement HAB’s study focusing on coordinate a full array of primary care Care and the Ryan White HIV/AIDS RWHAP outcomes within the context of and support services for their patients. Program study will compare HIV and the changing health care landscape; and These primary care and support services primary health outcomes across various will use the RWHAP site survey and have a direct impact on HIV viral models of care to determine which are chart abstraction instruments that were suppression, which in turn improves most effective in responding to HIV to submitted as part of that study. The data life expectancy and quality of life and improve health outcomes for people will be collected by a HRSA contractor. prevents HIV transmission. living with HIV and to prevent HIV Likely Respondents: RWHAP The two studies inform each other in transmissions. The results from this Administrators, RWHAP Service that the degree to which clients achieve study will enable improvements or Providers, and RWHAP Clients. and sustain viral suppression may be redesigns of effective delivery of HIV Burden Statement: Burden in this attributed partly to the model of care care among Ryan White HIV/AIDS context means the time expended by practiced at their clinic. Likewise, the Program providers, which will in turn persons to generate, maintain, retain, degree to which its clients have improve HIV clinical outcomes such as disclose or provide the information achieved viral suppression may drive a viral suppression. requested. This includes the time clinic to practice a particular model of In both studies, an analysis of the needed to review instructions; to care. The two studies will collect perceptions of providers and clients will develop, acquire, install, and utilize several identical data elements through further support the understanding of the technology and systems for the purpose their individual collection instruments, impact of individual and system-wide of collecting, validating, and verifying allowing data to be aggregated across the factors on achieving health outcomes. information, processing and two studies. The aggregation of data The two studies will share data to maintaining information, and disclosing across the two studies will minimize inform both studies’ objectives, allow and providing information; to train burden for RWHAP provider sites for a larger sample size from which to personnel and to be able to respond to collecting this data and will increase the generalize conclusions, and reduce the a collection of information; to search sample size for data analysis thus overall burden of response on RWHAP data sources; to complete and review resulting in more robust data and greater providers and clients. The objectives of the collection of information; and to generalizability of results. both studies will be achieved through transmit or otherwise disclose the A 60-day Federal Register Notice was collection of the following data: information. The total annual burden published in the Federal Register on • RWHAP client records hours estimated for this ICR are May 18, 2017 (Volume 82, page 22838) abstraction—Medical chart and summarized in the table below. Both which solicited comments on this data administrative records (e.g., service research studies are included in the collection. Four comments were utilization and health outcomes data); table, with burden proportional to the received that focused on how facilities • number of RWHAP provider sites from will be selected for participation and the RWHAP provider interviews—Site which each study will collect data: 25 importance of adequate nutrition for staff interviewees (in person); distinct facilities for Assessing Client PLWH. • RWHAP client focus groups Factors Associated with Detectable HIV Need and Proposed Use of the (Models of Care study sites only)— Viral Loads and 50 distinct facilities for Information: The Assessing Client Clients at selected clinics that represent Models of Care and the Ryan White Factors Associated with Detectable HIV a given model of care; HIV/AIDS Program. The table below Viral Loads study will identify • RWHAP client surveys (HIV Viral provides the level of burden inclusive of characteristics of RWHAP clients and Suppression study sites only)—Clients both studies. health facilities that are associated with with detectable and undetectable viral Total Estimated Annualized Burden— the ability to achieve and sustain an load at each clinic; and Hours.
12A—ESTIMATED ANNUALIZED BURDEN HOURS
Average Number of Number of Total burden per Total Type of respondent Form name respondents responses per responses response burden hours respondent (in hours)
RWHAP Site Administrators Medical Records Sample 75 1 75 1 75 (Private Sector). Selection Guide *. RWHAP Service Providers Provider Interview Guide 125 1 125 2 250 (Private Sector). (HIV Viral Suppression). RWHAP Service Providers Provider Interview Guide 250 1 250 2 500 (Private Sector). (Models of Care). RWHAP Clients (Individual/ Focus Groups Guide ...... 240 1 240 1.5 360 Household). RWHAP Clients (Individual/ Client Survey ...... 500 1 500 0.5 250 Household). RWHAP Clients (Individual/ Client Semi-Structured 150 1 150 0.5 75 Household). Interview.
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12A—ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Average Number of Number of Total burden per Total Type of respondent Form name respondents responses per responses response burden hours respondent (in hours)
Total ...... 1,340 ...... 1,340 ...... 1,510 * The medical records sample selection instrument has been previously submitted as part of the RWHAP Outcomes Study proposed data col- lection project.
HRSA specifically requests comments In the Summary section, correct to OMB No.: 0906–0004—Revision. on (1) the necessity and utility of the read: The effective date of the renewed Abstract: The National Marrow Donor proposed information collection for the charter is October 29, 2017. Program®/Be The Match® is a HRSA contractor dedicated to helping patients proper performance of the agency’s Amy McNulty, functions, (2) the accuracy of the and families get the support and Acting Director, Division of Executive information they need to learn about estimated burden, (3) ways to enhance Secretariat. their disease and treatment options, the quality, utility, and clarity of the [FR Doc. 2017–24490 Filed 11–9–17; 8:45 am] information to be collected, and (4) the prepare for a blood stem cell transplant, BILLING CODE 4165–15–P use of automated collection techniques and thrive after a transplant procedure. or other forms of information The information and resources provided help individuals navigate the bone technology to minimize the information DEPARTMENT OF HEALTH AND marrow or cord blood transplant collection\burden. HUMAN SERVICES process. Participant feedback is Amy McNulty, Health Resources and Services essential to understand the needs for Acting Director, Division of the Executive Administration transplant support services and Secretariat. educational information across a diverse [FR Doc. 2017–24491 Filed 11–9–17; 8:45 am] Agency Information Collection population. This information is used to BILLING CODE 4165–15–P Activities: Submission to OMB for determine the helpfulness of existing Review and Approval; Public Comment services and resources. Feedback is also Request; Be The Match® Patient used to identify areas for improvement DEPARTMENT OF HEALTH AND Services Survey, OMB No. 0906– and develop future programs. HUMAN SERVICES 0004—Revision Need and Proposed Use of the Information: Barriers to access to bone AGENCY: Health Resources and Services marrow or cord blood transplant related Health Resources and Services Administration (HRSA), Department of Administration care and educational information are Health and Human Services. multi-factorial. Feedback from National Advisory Committee on Rural ACTION: Notice. participants is essential to understand Health and Human Services; Notice of SUMMARY: In compliance with the the changing needs for services and Correction Paperwork Reduction Act of 1995, information as well as to demonstrate HRSA has submitted an Information the effectiveness of existing services. AGENCY: Health Resources and Services Collection Request (ICR) to the Office of The primary use for information Administration (HRSA), Department of Management and Budget (OMB) for gathered through the survey is to Health and Human Services (HHS). review and approval. Comments determine helpfulness of participants’ initial contact with Be The Match® ACTION: Notice; correction. submitted during the first public review of this ICR will be provided to OMB. Patient Services Coordinators (PSC) and OMB will accept further comments from to identify areas for improvement in the SUMMARY: The Health Resources and the public during the review and delivery of services. In addition, Services Administration published a approval period. stakeholders use this evaluation data to notice in the Federal Register, FR 2017– make program and resource allocation DATES: Comments on this ICR should be 23562 (October 31, 2017), announcing decisions. received no later than December 13, the charter renewal of the National The survey includes the following 2017. Advisory Committee on Rural Health items to measure: (1) Reason for and Human Services (NACRHHS). ADDRESSES: Submit your comments, contacting Be The Match®, (2) if the PSC including the ICR Title, to the desk was able to answer questions and easy FOR FURTHER INFORMATION CONTACT: Paul officer for HRSA, either by email to to understand, (3) if the contact helped Moore, Designated Federal Officer, [email protected] or by the participant to feel better prepared to NACRHHS, HRSA, 5600 Fishers Lane, fax to 202–395–5806. discuss transplant with their care team, Room 17W41C, Rockville, Maryland FOR FURTHER INFORMATION CONTACT: To (4) increase in awareness of available 20857, telephone (301) 443–0835, fax request a copy of the clearance requests resources, (5) timeliness of response, (301) 443–2803 or by email at pmoore2@ submitted to OMB for review, email Lisa and (6) overall satisfaction. hrsa.gov. Wright-Solomon, the HRSA Information Proposed changes to the survey Collection Clearance Officer at Correction instrument include updated references [email protected] or call (301) 443– to the survey title and staff titles. In the Federal Register, FR 2017– 1984. Changes to the questions include minor 23562 (October 31, 2017), please make SUPPLEMENTARY INFORMATION: changes to question one, changes to the the following correction: Information Collection Request Title: instructions for questions three and Be The Match® Patient Services Survey. four, and minor rewording of question
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six. Question eight is simplified. Coordinators via phone or email for develop, acquire, install, and utilize References to race and ethnicity are transplant navigation services and technology and systems for the purpose updated to better match preliminary support. The decision to survey all of collecting, validating, and verifying U.S. Census Bureau question format and participants was made based on historic information, processing and statements from the U.S. Department of evidence of patients’ unavailability due maintaining information, and disclosing Education to allow individuals to self- to frequent transitions in health status and providing information; (3) train identify their ethnicity and race and as well as transfer between home and personnel; (4) be able to respond to a permit individuals to select more than the hospital for initial treatment and collection of information; (5) search data one race and/or ethnicity. These care for complications. sources; (6) to complete and review the changes will not increase respondent Burden Statement: Burden in this collection of information; (7) and to burden. context means the time expended by transmit or otherwise disclose the Likely Respondents: Respondents will persons to generate, maintain, retain, information. The total annual burden include all patients, caregivers, and disclose, or provide the information hours estimated for this Information family members who have contact with requested. This includes the time Collection Request are summarized in Be The Match® Patient Services needed to: (1) Review instructions; (2) the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Average Number of Number of Total burden per Total burden Form name respondents responses per responses response hours respondent (in hours)
Be The Match® Patient Services Survey ...... 420 1 420 0.25 105
Total ...... 420 ...... 420 ...... 105
Amy McNulty, ADDRESSES: Submit your comments, activities and leadership role in assuring Acting Director, Division of the Executive including the ICR Title, to the desk a public health system for serving the Secretariat. officer for HRSA, either by email to MCH population. The proposed updates [FR Doc. 2017–24494 Filed 11–9–17; 8:45 am] [email protected] or by to the next edition of the guidance were BILLING CODE 4165–15–P fax to 202–395–5806. informed by comments received from FOR FURTHER INFORMATION CONTACT: To state Title V MCH program leadership, request a copy of the clearance requests national MCH leaders, family-led DEPARTMENT OF HEALTH AND submitted to OMB for review, email Lisa organizations, other MCH stakeholders HUMAN SERVICES Wright-Solomon, the HRSA Information and the public. Publication of a 60-day Collection Clearance Officer at Federal Register notice on June 9, 2017 Health Resources and Services [email protected] or call (301) 443– at 82 FR 26810, generated comments on Administration 1984. the proposed changes to the narrative SUPPLEMENTARY INFORMATION: reporting requirements, reporting forms, [OMB No. 0915–0172—Revision] Information Collection Request Title: definitions, consolidation of the 15 Title V Maternal and Child Health National Performance Measures (NPMs) Agency Information Collection into five domains, re-titling of a sixth Activities: Submission to OMB for Services Block Grant to States Program: Guidance and Forms for the Title V domain to ‘‘Cross-cutting and Systems Review and Approval; Public Comment Building,’’ reduction in the required Request; Title V Maternal and Child Application/Annual Report. OMB No.: 0915–0172—Revision. number of state-selected NPMs and Health Services Block Grant to States description of family partnerships. Program: Guidance and Forms for the Abstract: HRSA is updating the Title Specific updates to this edition of the Title V Application/Annual Report V Maternal and Child Health Services Block Grant to States Program: Title V Maternal and Child Health AGENCY: Health Resources and Services Guidance and Forms for the Title V Services Block Grant to States Program: Administration (HRSA), Department of Application/Annual Report. This Guidance and Forms for the Title V Health and Human Services. guidance is used annually by the 50 Application/Annual Report include the ACTION: Notice. states and 9 jurisdictions in applying for following: Block Grants under Title V of the Social (1) The current performance measure SUMMARY: In compliance with the Security Act and in preparing the framework is maintained, but the 15 Paperwork Reduction Act of 1995, required annual report. The updates National Performance Measures (NPMs) HRSA has submitted an Information proposed by HRSA’s Maternal and are now distributed within five Collection Request (ICR) to the Office of Child Health Bureau (MCHB) for this population domains (i.e., (Women/ Management and Budget (OMB) for edition of the guidance are intended to Maternal Health; Perinatal/Infant review and approval. Comments reinforce the reporting structure and Health; Child Health; Adolescent submitted during the first public review vision outlined in the previous edition Health; and Children with Special of this ICR will be provided to OMB. and to reinforce the role of the state in Health Care Needs (CSHCN)). OMB will accept further comments from developing a Title V Maternal and Child (2) The Cross-cutting/Life Course the public during the review and Health (MCH) Action Plan that responds domain is replaced by the Cross-cutting approval period. to its unique priority needs. These and Systems Building Domain, which is DATES: Comments on this ICR should be updates are intended to enable a state to an optional domain for states to include received no later than December 13, present an articulate and comprehensive as a State Performance Measure (SPM) 2017. description of its Title V program for addressing an identified priority
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need that is not aligned with one or of services. States are also encouraged to funds for their Title V MCH Services more of the five population health reflect on the impact of these services Block Grant to States Program to domains. The compound NPMs within the context of the identified HRSA’s MCHB (Section 505(a) of Title formerly included in the Cross-cutting/ priority needs and the measures V of the Social Security Act). In Life Course domain (i.e., NPM #13 and selected for the State Action Plan. addition, each state is required to NPM #14), along with NPM #15, are (8) Further anticipated reductions to conduct a statewide, comprehensive incorporated into the most relevant state burden are attained through more Needs Assessment every five years. The population health domain(s). streamlined narrative reporting, information and instructions for the (3) The required minimum number of particularly between the State preparation and submission of this NPMs to be selected by a state is Overview, Needs Assessment and State Application/Annual Report are reduced from eight to five. A state will Action Plan sections; clearer contained in the Title V Maternal and select at least one NPM in each of the descriptions of expected content in each Child Health Services Block Grant to five population health domains, but a of the narrative sections; and refined States Program: Guidance and Forms for state can choose to select additional instructions for completing the data the Title V Application/Annual Report. NPMs based on its current State Action reporting forms. Notable among these Likely Respondents: By legislation Plan and identified priority needs. updates is the restructuring of the State (Section 505(a) of Title V of the Social (4) A state has flexibility in the Action Plan narrative discussion to Security Act), the MCH Block Grant number of SPMs it develops, provided allow a state Title V program greater application/annual report must be each identified MCH priority need is flexibility in describing its public health developed by, or in consultation with, addressed by either a NPM and/or SPM. framework (e.g., life course model), the state MCH Health agency. (5) The development and leadership and partnership roles, cross- Burden Statement: Burden in this implementation of evidence-based and/ cutting strategies and the leveraging of context means the time expended by or evidence–informed strategies and resources. persons to generate, maintain, retain, measures continues to be a point of It is recognized that the full extent of disclose, or provide the information focus and an enhanced definition of the anticipated burden reduction will be requested. This estimate includes the ‘‘evidence-based,’’ clarifying realized over time as states become time needed to review instructions; to instructions and state examples of more familiar with the updated develop, acquire, install, and utilize Evidence-based or -informed Strategy instructions and reporting requirements. technology and systems for the purpose Measures are included. The burden estimates presented in the of collecting, validating, and verifying (6) Clearer expectations around state table below are based on previous information, processing and Title V reporting on family are outlined, burden estimates and consultations with maintaining information, and disclosing which include enhanced discussion of a few states on the proposed updates. and providing information; to train specific program activities, their impact Once implemented, HRSA will explore personnel and to be able to respond to on all sectors of the MCH population opportunities for soliciting additional a collection of information; to search and their demonstrated value in information from no more than nine data sources; to complete and review improving MCH outcomes. states to derive accurate estimates. the collection of information; and to (7) Narrative reporting requirements Need and Proposed Use of the transmit or otherwise disclose the around services for CSHCN are Information: Each year, all states and information. The total annual burden enhanced to allow each state to identify jurisdictions are required to submit an hours estimated for this ICR are and define the components of its system Application/Annual Report for Federal summarized in the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Number of Burden per Form name Number responses per Total response Total of respondents respondent responses (in hours) burden hours
Application and Annual Report without 5-Year Needs As- sessment Summary ...... 59 1 59 120 7,080 Application and Annual Report with 5-Year Needs Assess- ment Summary ...... 59 1 59 189 11,151
Average Total Annual Burden ...... 59 ...... 59 ...... * 8,437 * Reflects the average of one Application/Annual Report with a Five-Year Needs Assessment Summary and two Applications/Annual Reports without a Five-Year Needs Assessment Summary.
In fiscal year (FY) 2019 and FY 2020, development and submission of an electronic data entry system also states and jurisdictions will be application/annual Report under the contribute to reductions in state burden submitting an application and annual current guidance. The burden estimates associated with the yearly preparation/ report without a Five-year Needs reflect the average level of burden submission of an application/annual Assessment Summary for a total necessary to meet the specified Report. estimated burden of 14,160 hours. In FY reporting requirements. States often HRSA specifically requests comments 2021, states and jurisdictions will be report a range of burden hours due to on (1) the necessity and utility of the submitting an application and annual the differences in their population size, proposed information collection for the report with a five-year Needs program resources and the proper performance of the agency’s Assessment Summary for a total extensiveness of the processes they use functions; (2) the accuracy of the estimated burden of 11,151 hours. to conduct their five-year Needs estimated burden; (3) ways to enhance In deriving these estimates, HRSA Assessment and to prepare the yearly the quality, utility, and clarity of the contacted fewer than 10 states to discuss MCH Block Grant Applications/Annual information to be collected; and (4) the the level of burden associated with the Reports. Continued enhancements to the use of automated collection techniques
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or other forms of information 2. (Audio Portion) Calling the the administration of childhood technology to minimize the information conference phone number 1–800–369– vaccines, including the adverse reaction collection burden. 1833 and providing the following reporting requirements of section information: Amy McNulty, 2125(b) of the Act; advising the Leader Name: Dr. Narayan Nair. Secretary on the methods of obtaining, Acting Director, Division of the Executive Password: 6706374. compiling, publishing, and using Secretariat. 3. (Visual Portion) Connecting to the credible data related to the frequency [FR Doc. 2017–24495 Filed 11–9–17; 8:45 am] ACCV Adobe Connect Pro Meeting and severity of adverse reactions BILLING CODE 4165–15–P using the following URL: https:// hrsa.connectsolutions.com/accv/ (copy associated with childhood vaccines; and paste the link into your browser if consulting on the development or DEPARTMENT OF HEALTH AND it does not work directly, and enter as revision of Vaccine Information HUMAN SERVICES a guest). Participants should call and Statements; and recommending to the connect 15 minutes prior to the meeting Director of the National Vaccine Health Resources and Services in order for logistics to be set up. If you Program research related to vaccine Administration have never attended an Adobe Connect injuries which should be conducted to carry out the VICP. Advisory Commission on Childhood meeting, please test your connection Vaccines using the following URL: https:// The agenda items for the December 8, hrsa.connectsolutions.com/common/ 2017, meeting will include, but are not _ AGENCY: Health Resources and Services help/en/support/meeting test.htm and limited to, review of petitions to add Administration (HRSA), Department of get a quick overview by following URL: _ injuries to the vaccine injury table, and Health and Human Services (HHS). http://www.adobe.com/go/connectpro updates from DICP, Department of ACTION: Notice of meeting. overview. Justice (DOJ), National Vaccine Program FOR FURTHER INFORMATION CONTACT: Office (NVPO), Immunization Safety SUMMARY: In accordance with the Anyone requesting information Office (Centers for Disease Control and Federal Advisory Committee Act regarding the ACCV should contact (FACA), notice is hereby given that a Prevention), National Institute of Annie Herzog, Program Analyst, DICP, Allergy and Infectious Diseases meeting is scheduled for the Advisory HRSA in one of three ways: (1) Send a Commission on Childhood Vaccines (National Institutes of Health), and request to the following address: Annie Center for Biologics, Evaluation and (ACCV). This meeting will be open to Herzog, Program Analyst, DICP, HSB, the public. Information about the ACCV Research (Food and Drug HRSA, 5600 Fishers Lane, 08N146B, Administration). A draft agenda and and the agenda for this meeting can be Rockville, Maryland 20857; (2) call additional meeting materials will be obtained by accessing the following (301) 443–6593; or (3) send an email to posted on the ACCV Web site (http:// Web site: http://www.hrsa.gov/ [email protected]. advisorycommittees/childhoodvaccines/ The ACCV will meet on Friday, www.hrsa.gov/advisorycommittees/ index.html. December 8, 2017, beginning at 9:00 childhoodvaccines/index.html) prior to DATES: The meeting will be held on a.m. ET in the 5600 Fishers Lane the meeting. Agenda items are subject to December 8, 2017, at 9:00 a.m. ET. Building, Conference Room 5N54, change as priorities dictate. ADDRESSES: The address for the meeting Rockville, Maryland 20857; however, Members of the public will have the is 5600 Fishers Lane, Rockville, MD, meeting times and locations could opportunity to provide comments. Oral Conference Room 5N54. The public can change. For the latest information comments will be honored in the order join the meeting by: regarding meeting start time and they are requested and may be limited 1. (In Person) Persons interested in location, please check the ACCV Web as time allows. Requests to make oral attending the meeting in person are site: http://www.hrsa.gov/ comments or provide written comments encouraged to submit a written advisorycommittees/childhoodvaccines/ to the ACCV should be sent to Annie notification to: Annie Herzog, Division index.html. Herzog using the address and phone of Injury Compensation Programs SUPPLEMENTARY INFORMATION: The ACCV number above by December 4, 2017. (DICP), Healthcare Systems Bureau was established by section 2119 of the Individuals who plan to attend and (HSB), HRSA, Room 08N146B, 5600 Public Health Service Act (the Act) (42 need special assistance, such as sign Fishers Lane, Rockville, Maryland U.S.C. 300aa–19), as enacted by Public language interpretation or other 20857 or email: [email protected]. Law (Pub. L.) 99–660, and as reasonable accommodations, should Since this meeting is to be held in a subsequently amended, and advises the notify Annie Herzog, using the address federal government building, attendees Secretary of HHS (the Secretary) on and phone number above at least 10 will need to go through a security check issues related to implementation of the days prior to the meeting. to enter the building and participate in National Vaccine Injury Compensation the meeting. Written notification is Program (VICP). Amy McNulty, encouraged so that a list of attendees Other activities of the ACCV include: Acting Director, Division of the Executive can be provided to make entry through Recommending changes to the Vaccine Secretariat. security quicker. Persons may attend in Injury Table at its own initiative or as [FR Doc. 2017–24493 Filed 11–9–17; 8:45 am] person without providing written the result of the filing of a petition; BILLING CODE 4165–15–P notification, but their entry into the advising the Secretary in implementing building may be delayed due to security section 2127 of the Act regarding the checks and the requirement to be need for childhood vaccination escorted to the meeting by a federal products that result in fewer or no government employee. To request an significant adverse reactions; surveying escort to the meeting after entering the federal, state, and local programs and building, call Amber Johnson at (301) activities related to gathering 443–0129. information on injuries associated with
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DEPARTMENT OF HEALTH AND Scientific Review Program, Division of Place: National Institutes of Health, 5601 HUMAN SERVICES Extramural Activities, Room #3G20, National Fishers Lane, Rockville, MD 20892 (Virtual Institutes of Health/NIAID, 5601 Fishers Meeting). National Institutes of Health Lane, MSC 9823, Bethesda, MD 20892–9823, Contact Person: Amir E. Zeituni, Ph.D., (240) 669–5049, [email protected]. Scientific Review Officer, Scientific Review National Institute of Allergy and (Catalogue of Federal Domestic Assistance Program, Division of Extramural Activities, Infectious Diseases; Notice of Closed Program Nos. 93.855, Allergy, Immunology, NIAID/NIH/DHHS, 5601 Fishers Lane, MSC– Meetings and Transplantation Research; 93.856, 9834, Rockville, MD 20852, 301–496–2550, Microbiology and Infectious Diseases [email protected]. Pursuant to section 10(d) of the Research, National Institutes of Health, HHS) (Catalogue of Federal Domestic Assistance Federal Advisory Committee Act, as Dated: November 6, 2017. Program Nos. 93.855, Allergy, Immunology, and Transplantation Research; 93.856, amended, notice is hereby given of the Natasha M. Copeland, following meetings. Microbiology and Infectious Diseases The meetings will be closed to the Program Analyst, Office of Federal Advisory Research, National Institutes of Health, HHS) Committee Policy. public in accordance with the Dated: November 6, 2017. [FR Doc. 2017–24435 Filed 11–9–17; 8:45 am] provisions set forth in sections Natasha M. Copeland, BILLING CODE 4140–01–P 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Program Analyst, Office of Federal Advisory as amended. The grant applications and Committee Policy. the discussions could disclose DEPARTMENT OF HEALTH AND [FR Doc. 2017–24436 Filed 11–9–17; 8:45 am] confidential trade secrets or commercial HUMAN SERVICES BILLING CODE 4140–01–P property such as patentable material, and personal information concerning National Institutes of Health individuals associated with the grant DEPARTMENT OF HOMELAND applications, the disclosure of which National Institute of Allergy and SECURITY would constitute a clearly unwarranted Infectious Diseases; Notice of Closed invasion of personal privacy. Meetings Coast Guard Name of Committee: National Institute of [Docket No. USCG–2017–0954] Allergy and Infectious Diseases Special Pursuant to section 10(d) of the Emphasis Panel; Developmental Centers for Federal Advisory Committee Act, as Information Collection Request to AIDS Research (P30). amended, notice is hereby given of the Office of Management and Budget; Date: December 4–5, 2017. following meetings. Time: 8:30 a.m. to 5:00 p.m. OMB Control Number[s]: 1625–0085 Agenda: To review and evaluate grant The meetings will be closed to the AGENCY: Coast Guard, DHS. applications. public in accordance with the Place: Doubletree Hotel Bethesda, provisions set forth in sections ACTION: Sixty-day notice requesting (Formerly Holiday Inn Select) 8120 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., comments. Wisconsin Avenue, Bethesda, MD 20814. as amended. The grant applications and Contact Person: Jay R. Radke, Ph.D., AIDS the discussions could disclose SUMMARY: In compliance with the Review Branch, Scientific Review Program, confidential trade secrets or commercial Paperwork Reduction Act of 1995, the Division of Extramural Activities, Room U.S. Coast Guard intends to submit an #3G11B, National Institutes of Health, NIAID, property such as patentable material, and personal information concerning Information Collection Request (ICR) to 5601 Fishers Lane, MSC–9823, Bethesda, MD the Office of Management and Budget 20892–9823, (240) 669–5046, jay.radke@ individuals associated with the grant nih.gov. applications, the disclosure of which (OMB), Office of Information and Regulatory Affairs (OIRA), requesting an Name of Committee: National Institute of would constitute a clearly unwarranted Allergy and Infectious Diseases Special invasion of personal privacy. extension of its approval for the Emphasis Panel; Cellular Therapies for following collection of information Name of Committee: National Institute of Treatment of Radiation Injuries (U01). without change: 1625–0085, Allergy and Infectious Diseases Special Date: December 5, 2017. Streamlined Inspection Program. Our Emphasis Panel; NIAID Clinical Trial Time: 10:00 a.m. to 6:00 p.m. ICR describe the information we seek to Agenda: To review and evaluate grant Implementation Grant (R01). Date: December 7, 2017. collect from the public. Before applications. submitting this ICR to OIRA, the Coast Place: National Institutes of Health, 5601 Time: 1:00 p.m. to 2:00 p.m. Fishers Lane, Rockville, MD 20892 Agenda: To review and evaluate grant Guard is inviting comments as (Telephone Conference Call). applications. described below. Contact Person: Thomas F. Conway, Ph.D., Place: National Institutes of Health, 5601 DATES: Comments must reach the Coast Scientific Review Officer, Scientific Review Fishers Lane, Rockville, MD 20892 Guard on or before January 12, 2018. (Telephone Conference Call). Program, Division of Extramural Activities, ADDRESSES: You may submit comments Room 3G51, National Institutes of Health, Contact Person: Dharmendar Rathore, NIAID, 5601 Fishers Lane, MSC 9823, Ph.D., Senior Scientific Review Officer, identified by Coast Guard docket Bethesda, MD 20892–9823, 240–507–9685, Scientific Review Program, Division of number [USCG–2017–0954] to the Coast [email protected]. Extramural Activities, Room 3G30, National Guard using the Federal eRulemaking Name of Committee: National Institute of Institutes of Health/NIAID, 5601 Fishers Portal at http://www.regulations.gov. Allergy and Infectious Diseases Special Lane, Drive, MSC 9823, Bethesda, MD See the ‘‘Public participation and Emphasis Panel; AIDSRRC Independent SEP. 20892–9823, 240–669–5058, rathored@ request for comments’’ portion of the mail.nih.gov. Date: December 5, 2017. SUPPLEMENTARY INFORMATION section for Time: 2:00 p.m. to 4:30 p.m. Name of Committee: National Institute of further instructions on submitting Agenda: To review and evaluate grant Allergy and Infectious Diseases Special comments. Emphasis Panel; NIH Support for applications. A copy of the ICR is available through Place: National Institutes of Health, 5601 Conferences and Scientific Meetings (R13). Fishers Lane, Rockville, MD 20892 Date: December 11–15, 2017. the docket on the Internet at http:// (Telephone Conference Call). Time: 8:30 a.m. to 5:00 p.m. www.regulations.gov. Additionally, Contact Person: Peter R. Jackson, Ph.D., Agenda: To review and evaluate grant copies are available from: Commandant Chief, AIDS Research Review Branch, applications. (CG–612), ATTN: Paperwork Reduction
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Act Manager, U.S. Coast Guard, 2703 http://www.regulations.gov and can be DEPARTMENT OF THE INTERIOR Martin Luther King Jr. Ave. SE., Stop viewed by following that Web site’s 7710, Washington, DC 20593–7710. instructions. Additionally, if you go to Bureau of Land Management FOR FURTHER INFORMATION CONTACT: the online docket and sign up for email [LLOR957000.L63100000. HD0000. Contact Mr. Anthony Smith, Office of alerts, you will be notified when 18XL1109AF. HAG 18–0029] Information Management, telephone comments are posted. Filing of Plats of Survey: Oregon/ 202–475–3532, or fax 202–372–8405, for We accept anonymous comments. All Washington questions on these documents. comments received will be posted SUPPLEMENTARY INFORMATION: without change to http:// AGENCY: Bureau of Land Management, Public Participation and Request for www.regulations.gov and will include Interior. Comments any personal information you have ACTION: Notice of official filing. provided. For more about privacy and This Notice relies on the authority of the docket, you may review a Privacy SUMMARY: The plats of survey of the the Paperwork Reduction Act of 1995; Act notice regarding the Federal Docket following described lands are scheduled 44 U.S.C. Chapter 35, as amended. An Management System in the March 24, to be officially filed in the Bureau of ICR is an application to OIRA seeking 2005, issue of the Federal Register (70 Land Management (BLM), Oregon/ the approval, extension, or renewal of a FR 15086). Washington State Office, Portland, Coast Guard collection of information Oregon, 30 calendar days from the date (Collection). The ICR contains Information Collection Request of this publication. The surveys, which information describing the Collection’s were executed at the request of the purpose, the Collection’s likely burden Title: Streamlined Inspection BLM, are necessary for the management on the affected public, an explanation of Program. of these lands. the necessity of the Collection, and OMB Control Number: 1625–0085. DATES: Protests must be received by the other important information describing Summary: The Coast Guard BLM by December 13, 2017. the Collection. There is one ICR for each established an optional Streamlined ADDRESSES: Collection. A copy of the plats may be Inspection Program (SIP) to provide The Coast Guard invites comments on obtained from the Public Room at the owners and operators of U.S. vessels an whether this ICR should be granted BLM, Oregon/Washington State Office, alternative method of complying with based on the Collection being necessary 1220 SW 3rd Avenue, Portland, Oregon for the proper performance of inspection requirements of the Coast 97204, upon required payment. The Departmental functions. In particular, Guard. plats may be viewed at this location at the Coast Guard would appreciate Need: The SIP regulations under 46 no cost. Please use this address when comments addressing: (1) The practical CFR part 8, subpart E, offer owners and filing written protests. utility of the Collection; (2) the accuracy operators of inspected vessels an FOR FURTHER INFORMATION CONTACT: Kyle of the estimated burden of the alternative to traditional Coast Guard Hensley, (503) 808–6132, Branch of Collection; (3) ways to enhance the inspection procedures. Title 46 U.S.C. Geographic Sciences, BLM, 1220 SW quality, utility, and clarity of 3306 of authorizes the Coast Guard to 3rd Avenue, Portland, Oregon 97204. information subject to the Collection; prescribe regulations necessary to carry Persons who use a telecommunications and (4) ways to minimize the burden of out the inspections of vessels required device for the deaf (TDD) may call the the Collection on respondents, to be inspected under 46 U.S.C. 3103, Federal Relay Service (FRS) at 1–800– including the use of automated and 46 U.S.C. 3301 allows the Coast 877–8339 to contact the above collection techniques or other forms of Guard to rely on reports, documents, individual during normal business information technology. In response to and records of other persons who have hours. The FRS is available 24 hours a your comments, we may revise this ICR been determined to be reliable, and day, 7 days a week, to leave a message or decide not to seek an extension of other methods that have been or question with the above individual. approval for the Collection. We will determined to be reliable to ensure You will receive a reply during normal business hours. consider all comments and material compliance with vessels and seamen received during the comment period. requirements under 46 U.S.C. subtitle II. SUPPLEMENTARY INFORMATION: The plats We encourage you to respond to this of survey of the following described Forms: None. request by submitting comments and lands are scheduled to be officially filed related materials. Comments must Respondents: Owners and operators in the BLM, Oregon/Washington State contain the OMB Control Number of the of vessels. Office, Portland, Oregon: ICR and the docket number of this Frequency: On occasion. Willamette Meridian, Oregon request, [USCG–2017–0954], and must Hour Burden Estimate: The estimated T. 11 S., R. 4 E., accepted September 22, 2017 be received by January 12, 2018. burden has increased from 2,334 hours A person or party who wishes to Submitting Comments to 8,254 hours a year due to an increase protest one or more plats of survey We encourage you to submit in the number of SIP participants (i.e., identified above must file a written comments through the Federal companies and vessels). notice of protest with the State Director eRulemaking Portal at http:// Authority: The Paperwork Reduction Act for Oregon/Washington, BLM. The www.regulations.gov. If your material of 1995; 44 U.S.C. Chapter 35, as amended. notice of protest must identify the cannot be submitted using http:// plat(s) of survey that the person or party Dated: November 2, 2017. www.regulations.gov, contact the person wishes to protest. The notice of protest in the FOR FURTHER INFORMATION James D. Roppel, must be filed before the scheduled date CONTACT section of this document for U.S. Coast Guard, Acting Chief, Office of of official filing for the plat(s) of survey alternate instructions. Documents Information Management. being protested. Any notice of protest mentioned in this notice, and all public [FR Doc. 2017–24489 Filed 11–9–17; 8:45 am] filed after the scheduled date of official comments, are in our online docket at BILLING CODE 9110–04–P filing will not be considered. A notice
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of protest is considered filed on the date SUMMARY: In compliance with the Comments that you submit in it is received by the State Director for Paperwork Reduction Act of 1995, we, response to this notice are a matter of Oregon/Washington during regular the Bureau of Land Management (BLM) public record. We will include or business hours; if received after regular are proposing to renew an information summarize each comment in our request business hours, a notice of protest will collection. to OMB to approve this ICR. Before be considered filed the next business DATES: Interested persons are invited to including your address, phone number, day. A written statement of reasons in submit comments on or before January email address, or other personal support of a protest, if not filed with the 12, 2018. identifying information in your notice of protest, must be filed with the ADDRESSES: Send your comments on comment, you should be aware that State Director for Oregon/Washington this information collection request (ICR) your entire comment—including your within 30 calendar days after the notice by mail to the Jean Sonneman, U.S. personal identifying information—may of protest is filed. If a notice of protest Department of the Interior, Bureau of be made publicly available at any time. against a plat of survey is received prior Land Management, 1849 C Street NW., While you can ask us in your comment to the scheduled date of official filing, Room 2134LM, Washington, DC 20240; to withhold your personal identifying the official filing of the plat of survey or by email to [email protected]. information from public review, we identified in the notice of protest will be Please reference OMB Control Number cannot guarantee that we will be able to stayed pending consideration of the 1004–0201 in the subject line of your do so. protest. A plat of survey will not be comments. The following information is provided officially filed until the next business FOR FURTHER INFORMATION CONTACT: To for the information collection: day following dismissal or resolution of request additional information about Abstract: This control number applies all protests of the plat. this ICR, please contact Mary Linda to the exploration, development, and Before including your address, phone Ponticelli by email at mpontice@ utilization of oil shale resources on the number, email address, or other blm.gov or, by phone at 202–912–7115. BLM-managed public lands. Currently, personal identifying information in a Persons who use a telecommunication the only oil shale leases issued by the notice of protest or statement of reasons, device for the deaf may call the Federal BLM are for research, development, and you should be aware that the documents Information Relay Service at 1–800– demonstration (RD&D) leases. However, you submit—including your personal 877–8339 to leave a message for the the BLM regulations provide a identifying information—may be made above person. framework for commercial oil shale leasing and additionally include publicly available in their entirety at SUPPLEMENTARY INFORMATION: In any time. While you can ask us to accordance with the Paperwork provisions for conversion of RD&D withhold your personal identifying Reduction Act of 1995, we provide the leases to commercial leases. information from public review, we general public and other Federal Title of Collection: Oil Shale cannot guarantee that we will be able to agencies with an opportunity to Management (43 CFR parts 3900, 3910, do so. comment on new, proposed, revised, 3920, and 3930). Authority: 43 U.S.C. Chap. 3. and continuing collections of OMB Control Number: 1004–0201. information. This helps us assess the Form Number: None. Mary J.M. Hartel, impact of our information collection Type of Review: Extension of a Chief Cadastral Surveyor of Oregon/ requirements and minimize the public’s currently approved collection. Washington. reporting burden. It also helps the Respondents/Affected Public: [FR Doc. 2017–24529 Filed 11–9–17; 8:45 am] public understand our information Applicants for oil shale leases, oil shale BILLING CODE 4310–33–P collection requirements and provide the lessees and oil shale operators. requested data in the desired format. Total Estimated Number of Annual We are soliciting comments on the Respondents: 24. DEPARTMENT OF THE INTERIOR proposed ICR that is described below. Total Estimated Number of Annual We are especially interested in public Responses: 24. Bureau of Land Management comment addressing the following Estimated Completion Time per issues: (1) Is the collection necessary to Response: Varies from the number of [LLAK930000.L13100000.FF0000.241A]; the proper functions of the BLM; (2) will minutes/hours per response. OMB Control No. 1004–0201 this information be processed and used Total Estimated Number of Annual in a timely manner; (3) is the estimate Burden Hours: 1,795. Agency Information Collection of burden accurate; (4) how might the Respondent’s Obligation: Required to Activities; Oil Shale Management BLM enhance the quality, utility, and obtain a benefit. AGENCY: Bureau of Land Management, clarity of the information to be Frequency of Collection: On occasion. Interior. collected; and (5) how might the BLM Total Estimated Annual Non Hour minimize the burden of the collection Burden Cost: $526,632. ACTION: Notice of information collection; on the respondents, including through The estimated burdens are itemized in request for comment. the use of information technology. the following table:
Total time Type of response Number of Hours per (column B × responses response column C)
A B. C D
Application for Waiver, Suspension, or Reduction of Rental or Payment In Lieu of Production; Application for Reduction in Royalty; or Application for Waiver of Royalty, 43 CFR 3903.54(b) ...... 1 1 1 Bonding Requirements, 43 CFR Subpart 3904 ...... 1 1 1 Application for an Exploration License, 43 CFR 3910.31(a) through (e) ...... 1 24 24
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Total time Type of response Number of Hours per (column B × responses response column C)
A B. C D
Notice Seeking Participation in an Exploration License, 43 CFR 3910.31(f) ...... 1 1 1 Data Obtained Under an Exploration License, 43 CFR 3910.44 ...... 1 8 8 Response to Call for Expression of Leasing Interest, 43 CFR 3921.30 ...... 1 4 4 Application for a Lease — Individuals, 43 CFR 3902.23, 3922.20, and 3922.30 ...... 1 308 308 Application for a Lease — Associations, 43 CFR 3902.24, 3922.20, and 3922.30 ...... 1 308 308 Application for a Lease — Corporations, 43 CFR 3902.25, 3922.20, and 3922.30 ...... 1 308 308 Sealed Bid, 43 CFR 3924.10 ...... 1 8 8 Application to Convert Research, Development, and Demonstration Lease to Commercial Lease, 43 CFR 3926.10(c) ...... 1 308 308 Drill and Geophysical Logs, 43 CFR 3930.11(b) ...... 1 19 19 New Geologic Information, 43 CFR 3930.20(b) ...... 1 19 19 Plan of Development, 43 CFR 3931.11 ...... 1 308 308 Application for Suspension of Lease Operations and Production, 43 CFR 3931.30 ...... 1 24 24 Exploration Plan, 43 CFR 3931.41 ...... 1 24 24 Modification of Approved Exploration Plan or Plan of Development, 43 CFR 3931.50 ...... 1 24 24 Production Maps and Production Reports, 43 CFR 3931.70 ...... 1 16 16 Records of Core or Test Hole Samples and Cuttings, 43 CFR 3931.80 ...... 1 16 16 Application for Modification of Lease Size, 43 CFR 3932.10, 3930.20, and 3932.30 ...... 1 12 12 Request for Approval of Assignment of Record Title or Sublease or Notice of Overriding Roy- alty Interest Assignment, 43 CFR Subpart 3933 ...... 2 10 20 Relinquishment of Lease or Exploration License, 43 CFR 3934.10 ...... 1 18 18 Production and Sale Records, 43 CFR 3935.10 ...... 1 16 16
Totals ...... 24 ...... 1,795
The authorities for this action are the By order of the Commission. Chicago, IL, have been added as parties Mineral Leasing Act of 1920, the Issued: November 7, 2017. to this venture. Mineral Leasing Act for Acquired Lands Lisa R. Barton, No other changes have been made in Act of 1947, the Federal Land Policy Secretary to the Commission. either the membership or planned and Management Act of 1976 and the EP [FR Doc. 2017–24530 Filed 11–9–17; 8:45 am] activity of the group research project. Act and the Paperwork Reduction Act of BILLING CODE 7020–02–P Membership in this group research 1995 (44 U.S.C. 3501, et seq.). project remains open, and Pistoia Jean Sonneman, Alliance, Inc. intends to file additional Information Collection Clearance Officer, written notifications disclosing all Bureau of Land Management. DEPARTMENT OF JUSTICE changes in membership. [FR Doc. 2017–24528 Filed 11–9–17; 8:45 am] Antitrust Division On May 28, 2009, Pistoia Alliance, BILLING CODE 4310–84–P Inc. filed its original notification Notice Pursuant to the National pursuant to Section 6(a) of the Act. The Cooperative Research and Production Department of Justice published a notice INTERNATIONAL TRADE Act of 1993—Pistoia Alliance, Inc. in the Federal Register pursuant to COMMISSION Section 6(b) of the Act on July 15, 2009 Notice is hereby given that, on (74 FR 34364). [Investigation No. 337–TA–945 (Modification October 3, 2017, pursuant to Section Proceeding)] 6(a) of the National Cooperative The last notification was filed with Research and Production Act of 1993, the Department on July 12, 2017. A Certain Network Devices, Related notice was published in the Federal Software and Components Thereof (II); 15 U.S.C. 4301 et seq. (‘‘the Act’’), Pistoia Alliance, Inc. has filed written Register pursuant to Section 6(b) of the Notice of Correction Concerning the Act on August 16, 2017 (82 FR 38939). Institution of Modification Proceeding notifications simultaneously with the Attorney General and the Federal Trade Patricia A. Brink, AGENCY: U.S. International Trade Commission disclosing changes in its Director of Civil Enforcement, Antitrust Commission. membership. The notifications were Division. ACTION: Correction of notice. filed for the purpose of extending the Act’s provisions limiting the recovery of [FR Doc. 2017–24544 Filed 11–9–17; 8:45 am] SUMMARY: Correction is made to notice antitrust plaintiffs to actual damages BILLING CODE P 82 FR 50678, which was published on under specified circumstances. Wednesday, November 1, 2017, to Specifically, Luxoft Global Operations clarify that the Office of Unfair Import GmbH, Zug, SWITZERLAND; Congenica Investigations is not named as a party in Limited, Hinxton, UNITED KINGDOM; this modification proceeding. Any Jeremy G. Frey (individual member), inclusion of the Office of Unfair Import Highfield, UNITED KINGDOM; The Investigations as a named party in this HDF Group, Champaign, IL; BioRAFT, proceeding is hereby corrected in the Cambridge, MA; Cyclica, Toronto, Notice of Institution. CANADA; and AbbVie Inc., North
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DEPARTMENT OF JUSTICE Competitive Impact Statement have and to obtain other equitable relief. The been filed with the United States acquisition likely would substantially Antitrust Division District Court for the District of lessen competition for the sale of radio Columbia in United States of America v. advertising to advertisers targeting Notice Pursuant to the National Entercom Communications Corp., Case English-language listeners in the Boston, Cooperative Research and Production No. 1:17–cv–02268. On November 1, Sacramento, and San Francisco Act of 1993—Cooperative Research 2017, the United States filed a Designated Market Areas (‘‘DMAs’’), in Group on ROS-Industrial Consortium- Complaint alleging that Entercom violation of Section 7 of the Clayton Americas Communications Corp.’s proposed Act, 15 U.S.C. 18. The United States Notice is hereby given that, on acquisition of CBS Radio, Inc. would alleges as follows: violate Section 7 of the Clayton Act, 15 October 18, 2017, pursuant to Section I. NATURE OF THE ACTION 6(a) of the National Cooperative U.S.C. 18. The proposed Final Research and Production Act of 1993, Judgment, filed on the same day as the 1. Pursuant to an Agreement and Plan 15 U.S.C. 4301 et seq. (‘‘the Act’’), Complaint, resolves the case by of Merger dated February 2, 2017, Southwest Research Institute— requiring Entercom to divest certain between Entercom, CBS Radio, Inc. and Cooperative Research Group on ROS- broadcast television stations in Boston, CBS Corporation, Entercom agreed to Industrial Consortium-Americas (‘‘RIC- Massachusetts; San Francisco, acquire CBS Radio in a Reverse Morris Americas’’) has filed written California; and Sacramento, California. Trust transaction valued at over $1.6 notifications simultaneously with the A Competitive Impact Statement filed billion. CBS Radio is a subsidiary of Attorney General and the Federal Trade by the United States describes the CBS Corporation. Commission disclosing changes in its Complaint, the proposed Final 2. Entercom and CBS Radio own and Membership. The notifications were Judgment, and the industry. operate broadcast radio stations in filed for the purpose of extending the Copies of the Complaint, proposed various locations throughout the United Act’s provisions limiting the recovery of Final Judgment, and Competitive Impact States, including multiple stations in antitrust plaintiffs to actual damages Statement are available for inspection Boston, Massachusetts, Sacramento, under specified circumstances. on the Antitrust Division’s website at California, and San Francisco, Specifically, Tormach, Inc., Waunakee, http://www.justice.gov/atr and at the California. Entercom and CBS Radio WI, has been added as a party to this Office of the Clerk of the United States compete head-to-head for the business venture. District Court for the District of of local and national companies that No other changes have been made in Columbia. Copies of these materials may seek to advertise on English-language either the membership or planned be obtained from the Antitrust Division broadcast radio stations in these three activity of the group research project. upon request and payment of the DMAs. copying fee set by Department of Justice Membership in this group research 3. As alleged in greater detail below, regulations. project remains open and RIC-Americas the proposed acquisition would intends to file additional written Public comment is invited within 60 days of the date of this notice. Such eliminate this substantial head-to-head notifications disclosing all changes in competition in Boston, Sacramento, and membership or planned activities. comments, including the name of the submitter, and responses thereto, will be San Francisco, and likely would result On April 30, 2014, RIC-Americas filed in advertisers paying higher prices for its original notification pursuant to posted on the Antitrust Division’s website, filed with the Court, and, under radio advertising. Therefore, the Section 6(a) of the Act. The Department proposed acquisition would violate of Justice published a notice in the certain circumstances, published in the Federal Register. Comments should be Section 7 of the Clayton Act, 15 U.S.C. Federal Register pursuant to Section 18, and should be enjoined. 6(b) of the Act on June 9, 2014 (79 FR directed to Owen M. Kendler, Chief, 32999). Media, Entertainment, and Professional II. JURISDICTION, VENUE, AND The last notification was filed with Services Section, Antitrust Division, COMMERCE Department of Justice, Washington, DC the Department on April 7, 2017. A 4. The United States brings this action 20530, (telephone: 202–305–8376). notice was published in the Federal under the direction of the Attorney Register pursuant to Section 6(b) of the Patricia A. Brink, General and pursuant to Section 15 of Act on May 2, 2017 (82 FR 20488). Director of Civil Enforcement. the Clayton Act, as amended, 15 U.S.C. 25, to prevent and restrain Entercom Patricia A. Brink, UNITED STATES DISTRICT COURT and CBS Corp. from violating Section 7 Director of Civil Enforcement, Antitrust FOR THE DISTRICT OF COLUMBIA Division. of the Clayton Act, 15 U.S.C. 18. The [FR Doc. 2017–24545 Filed 11–9–17; 8:45 am] UNITED STATES OF AMERICA, United Court has subject-matter jurisdiction States Department of Justice, Antitrust BILLING CODE P over this action pursuant to Section 15 Division, 450 Fifth Street NW., Suite 4000, of the Clayton Act, 15 U.S.C. 25, and 28 Washington, DC 20530 Plaintiff, v. ENTERCOM COMMUNICATIONS CORP., U.S.C. 1331, 1337(a), and 1345. DEPARTMENT OF JUSTICE 401 E. City Avenue, Suite 809, Bala Cynwyd, 5. Entercom and CBS Corporation are PA 19004 and CBS CORPORATION, 51 W. engaged in interstate commerce and in Antitrust Division 52nd Street, New York, NY 10019 activities substantially affecting United States v. Entercom Case No: 1:17–cv–02268 interstate commerce. They own and Communications Corp., et al.; Judge: Boasberg operate broadcast radio stations in Proposed Final Judgment and Defendants. various locations throughout the United Competitive Impact Statement States and sell radio advertising time on COMPLAINT those stations to advertisers located Notice is hereby given pursuant to the The United States of America brings throughout the United States. Antitrust Procedures and Penalties Act, this civil action to enjoin the proposed Defendants’ radio advertising sales have 15 U.S.C. 16(b)–(h), that a proposed acquisition of CBS Radio, Inc. by a substantial effect upon interstate Final Judgment, Stipulation, and Entercom Communications Corporation, commerce.
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6. Defendants Entercom and CBS audience at the desired frequency. In group owners account for the bulk of the Corporation transact business in the addition, radio stations offer certain advertising revenues. Entercom’s and District of Columbia and have consented promotional opportunities to CBS Radio’s combined advertising to venue and personal jurisdiction in advertisers, such as on-air endorsements revenue shares would exceed 40% in this District. Venue is proper in this by local radio personalities, that San Francisco, 50% in Boston, and 55% District under Section 12 of the Clayton advertisers cannot obtain as effectively in Sacramento. Act, 15 U.S.C. 22 and 28 U.S.C. 1391(c). using other media. 17. As articulated in the Horizontal 12. Many local and national Merger Guidelines issued by the III. THE DEFENDANTS advertisers consider English-language Department of Justice and the Federal 7. Entercom, a Pennsylvania broadcast radio to be a particularly Trade Commission, the Herfindahl- corporation with its headquarters in effective or important means to reach Hirschman Index (‘‘HHI’’) is a measure Bala Cynwyd, Pennsylvania, is the their desired customers, and do not of market concentration.1 Market fourth-largest broadcast radio company consider advertisements on other media, concentration is often one useful in the United States. It has a portfolio including non-English-language indicator of the likely competitive of 127 stations in 27 markets. In 2016, broadcast radio, digital music streaming effects of a merger. The more Entercom reported net revenues of services (such as Pandora), and concentrated a market, and the more a approximately $460 million. television, to be reasonable substitutes. transaction would increase 8. CBS Corporation is incorporated in 13. In addition, radio stations concentration in a market, the more Delaware and maintains its negotiate prices individually with likely it is that a transaction would headquarters in New York, New York. advertisers; consequently, radio stations result in a meaningful reduction in Its wholly-owned subsidiary, CBS can charge different advertisers different competition harming consumers. Radio, owns 117 stations in 26 DMAs. prices. Radio stations generally can Mergers resulting in highly concentrated In 2016, CBS Radio reported net identify advertisers with strong markets (with an HHI in excess of 2,500) revenues of approximately $1.2 billion. preferences to advertise on radio in a that involve an increase in the HHI of IV. RELEVANT MARKETS particular language in a specific DMA. more than 200 points are presumed to Because of this ability to price be likely to enhance market power. 9. Entercom and CBS Radio sell radio discriminate among customers, radio 18. Concentration in the Boston DMA advertising time to local and national stations may charge higher prices to would increase substantially as a result advertisers that target English-language advertisers that view English-language of the proposed acquisition: the post- listeners in the Boston, Sacramento, and radio advertising in a specific DMA as acquisition HHI would exceed 3,600 for San Francisco DMAs. A DMA is a particularly effective for their needs, English-language broadcast radio geographical unit in which the Nielsen while maintaining lower prices for more stations, with an increase of over 1,200 Company surveys radio listeners in price-sensitive advertisers. As a result, points. order to furnish radio stations, Entercom and CBS Radio could 19. Concentration in the Sacramento advertisers, and advertising agencies profitably raise prices to those DMA would increase substantially as a with data to aid in evaluating radio advertisers that view English-language result of the proposed acquisition: the audiences. DMAs are widely accepted radio targeting listeners in the Boston, post-acquisition HHI would exceed by industry participants as the standard Sacramento, or San Francisco DMAs as 4,300 for English-language broadcast geographic boundaries to use in an important advertising medium. radio stations, with an increase of over evaluating radio audience size and 14. If there were a small but 1,600 points. demographic composition. A radio significant and non-transitory increase 20. Concentration in the San station’s advertising rates are directly in the price of radio advertising time on Francisco DMA would increase related to the station’s ability, relative to English-language stations in the Boston, substantially as a result of the proposed competing radio stations, to attract Sacramento, and San Francisco DMAs, acquisition: the post-acquisition HHI listeners within a DMA that have advertisers would not reduce their would exceed 2,800 for English- demographic characteristics that purchases sufficiently to render the language broadcast radio stations, with advertisers want to reach. price increase unprofitable. Advertisers an increase of over 800 points. 10. The primary source of revenue for would not switch enough purchases of 21. In addition to increasing Entercom and CBS Radio is the sale of advertising time to radio stations concentration, the merger also combines advertising time to local and national outside the DMA, to other media, or to stations that are close substitutes and advertisers who want to reach listeners non-English-language radio stations to vigorous head-to-head competitors. in one or more DMAs. Advertising render the price increase unprofitable. Advertisers that use radio to reach their placed on radio stations in a DMA is 15. Accordingly, the sale of broadcast target audiences select radio stations on aimed at reaching listening audiences radio advertising time to advertisers which to advertise based upon a number located in that DMA, and radio stations targeting English-language listeners is a of factors including, among others, the outside that DMA do not provide line of commerce and a relevant product effective access to these audiences. market within the meaning of Section 7 1 See U.S. Dep’t of Justice, Horizontal Merger 11. Local and national advertisers Guidelines § 5.3 (2010), available at http:// of the Clayton Act. The Boston, www.justice.gov/atr/public/guidelines/hmg- purchase radio advertising time because Sacramento, and San Francisco DMAs 2010.html. The HHI is calculated by squaring the they find such advertising valuable, constitute relevant geographic markets market share of each firm competing in the market either by itself or as part of a broader within the meaning of Section 7 of the and then summing the resulting numbers. For mix of advertising on other media Clayton Act. example, for a market consisting of four firms with platforms. Advertisers use broadcast shares of 30, 30, 20, and 20 percent, the HHI is V. ANTICOMPETITIVE EFFECTS 2,600 (302 + 302 + 202 + 202 = 2,600). It approaches radio for many reasons, including that zero when a market is occupied by a large number radio advertising offers a high level of 16. Post merger, radio station of firms of relatively equal size and reaches a audience reach, as well as a stable ownership in the Boston, Sacramento maximum of 10,000 points when a market is controlled by a single firm. The HHI increases both listenership, and it is often a more and San Francisco DMAs would be as the number of firms in the market decreases and efficient means than other advertising highly concentrated. In each of these as the disparity in size between those firms platforms to reach an advertiser’s target markets, a small number of station- increases.
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size of a station’s audience, its 25. Due to FCC regulation, the lack of Donald G. Kempf, Jr. demographic composition, and the available spectrum, and other Deputy Assistant Attorney General geographic reach of its broadcast signal. significant barriers, the entry of new Antitrust Division lllllllllllllllllll broadcast radio stations into the Boston, /s/ Many advertisers select stations whose Patricia A. Brink listening audiences best correlate to Sacramento, and San Francisco DMAs Director of Civil Enforcement their target audience. If a number of would not be timely, likely, or sufficient Antitrust Division stations, or combinations of stations, to deter the exercise of market power. /s/ lllllllllllllllllll broadcasting in the same DMA 26. For all of these reasons, the effect Owen M. Kendler efficiently reach a particular target of the proposed acquisition of CBS Chief audience, advertisers benefit from the Radio by Entercom would likely be to Yvette F. Tarlov competition among those stations to lessen competition substantially in Lisa A. Scanlon Assistant Chiefs offer better prices and other terms. violation of Section 7 of the Clayton Media, Entertainment, and Professional 22. Entercom and CBS Radio, each of Act. Services Section which operates multiple highly-rated VI. VIOLATION ALLEGED /s/ lllllllllllllllllll radio stations in the Boston, Bennett J. Matelson* (D.C. Bar #454551) Sacramento, and San Francisco DMAs, 27. Entercom’s proposed acquisition Mark A. Merva (D.C. Bar #451743) are important competitors for listeners of CBS Radio would likely substantially Lauren Riker and advertisers in those DMAs. From lessen competition in interstate trade Adam Speegle the perspective of many local and and commerce in violation of Section 7 Jeffrey Vernon national advertisers buying radio of the Clayton Act, 15 U.S.C. § 18, and United States Department of Justice, Antitrust Division, Media, Entertainment, advertising time in those DMAs, would likely have the following effects, among others: and Professional Services Section, 450 Fifth Entercom and CBS Radio are two of a Street, NW, Suite 4000, Washington, DC limited number of station groups whose a) competition in the sale of 20530, Telephone: (202) 616–5871, large and diverse listenership allows advertising time on English-language Facsimile: (202) 514–7308, Email: advertisers to meet their reach and broadcast radio stations in the Boston, [email protected] frequency goals with respect to their Sacramento, and San Francisco DMAs *Attorney of Record target audience. Entercom and CBS would be substantially lessened; UNITED STATES DISTRICT COURT Radio compete vigorously to win b) competition between Entercom FOR THE DISTRICT OF COLUMBIA business from advertisers and broadcast radio stations and CBS substantially constrain each other’s broadcast radio stations in the sale of UNITED STATES OF AMERICA Plaintiff, prices. radio advertising time in the Boston, v. ENTERCOM COMMUNICATIONS CORP. 23. During individual negotiations Sacramento, and San Francisco DMAs and CBS CORPORATION Defendants. would be eliminated; and between advertisers and radio stations, Case No. 1:17–cv–02268 advertisers often provide the stations c) prices for advertising time on Judge: Boasberg with information about their advertising English-language radio stations in the needs, including their target audience Boston, Sacramento, and San Francisco COMPETITIVE IMPACT STATEMENT DMAs would likely increase. and the desired frequency and timing of Pursuant to Section 2(b) of the ads. Radio stations have the ability to VII. REQUESTED RELIEF Antitrust Procedures and Penalties Act charge advertisers differing rates based 28. The United States requests that (‘‘APPA’’ or ‘‘Tunney Act’’), 15 U.S.C. in part on the number and attractiveness this Court: § 16(b)–(h), plaintiff United States of of competitive radio stations that can a) adjudge and decree Entercom’s America (‘‘United States’’) files this meet a particular advertiser’s specific proposed acquisition of CBS Radio to be Competitive Impact Statement relating target needs. During negotiations, unlawful and in violation of Section 7 to the proposed Final Judgment advertisers can gain more competitive of the Clayton Act, 15 U.S.C. § 18; submitted for entry in this civil antitrust rates and other terms by ‘‘playing off’’ b) permanently enjoin and restrain the proceeding. Entercom stations against CBS Radio Defendants from carrying out the stations, either individually or as a I. NATURE AND PURPOSE OF THE proposed acquisition or from entering cluster. The proposed acquisition would PROCEEDING into or carrying out any other contract, end that competition, resulting in harm agreement, plan, or understanding, the The United States filed a civil to advertisers. effect of which would be to combine antitrust Complaint on November 1, 24. Post-acquisition, if Entercom CBS Radio with Entercom; 2017 seeking to enjoin Entercom raised prices to those advertisers that c) award the United States the costs Communications Corporation’s buy advertising time on Entercom of this action; and (‘‘Entercom’’) proposed acquisition of stations in the Boston, Sacramento and d) award such other relief to the broadcast radio stations from CBS San Francisco DMAs, non-Entercom United States as the Court may deem Corporation (‘‘CBS’’). The Complaint stations in those DMAs would likely just and proper. alleges that the acquisition’s likely effect respond with higher prices of their own would be to increase English-language rather than alter their existing formats to Dated: November 1, 2017 broadcast radio advertising prices in the attract the Entercom stations’ listeners Respectfully submitted, following Designated Market Areas and advertisers. Repositioning a station FOR PLAINTIFF UNITED STATES: (‘‘DMAs’’) in violation of Section 7 of by changing format is costly and risky, /s/ lllllllllllllllllll the Clayton Act, 15 U.S.C. § 18: Boston, with the potential to lose substantial Makan Delrahim Massachusetts; San Francisco, numbers of existing listeners and Assistant Attorney General Antitrust Division California; and Sacramento, California advertisers. In addition, re-formatting is /s/ lllllllllllllllllll (collectively ‘‘the Divestiture Markets’’). unlikely to attract in a timely manner Andrew C. Finch At the same time the Complaint was sufficient listeners and advertisers to Principal Deputy Assistant Attorney General filed, the United States also filed a Hold make a price increase unprofitable for Antitrust Division Separate Stipulation and Order (‘‘Hold Entercom. /s/ lllllllllllllllllll Separate’’) and a proposed Final
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Judgment, which are designed to B. Anticompetitive Consequences of the advertisers that use English-language eliminate the anticompetitive effects of Transaction radio, either alone or as a mix with other media platforms to reach their the proposed acquisition in the 1. Broadcast Radio Advertising Divestiture Markets. The proposed Final target audience, generally do not Judgment, which is explained more The Complaint alleges that the sale of consider other media, including non- fully below, requires defendants to English-language broadcast radio English-language radio, such as divest the following broadcast radio advertising time to advertisers targeting Spanish-language radio, for example, to stations (the ‘‘Divestiture Stations’’) to listeners located in the Divestiture be a reasonable substitute. acquirers approved by the United States Markets constitutes a relevant market If there were a small but significant for analyzing this acquisition under in a manner that preserves competition: and non-transitory increase in the price Section 7 of the Clayton Act. Each of the (1) in the Boston DMA: WBZ AM, WBZ (‘‘SSNIP’’) of advertising time on Divestiture Markets constitutes a FM, WKAF FM, WZLX FM, and WRKO English-language broadcast radio distinct DMA. A DMA is a geographical AM; (2) in the San Francisco DMA: stations in the Divestiture Markets, unit defined by the Nielsen Company, advertisers would not reduce their KOIT FM, KMVQ FM, KUFX FM, and which surveys radio listeners in order to KBLX FM; and (3) in the Sacramento purchases sufficiently to render the furnish radio stations, advertisers, and price increase unprofitable. Advertisers DMA: KNCI FM, KYMX FM, KZZO FM advertising agencies with data to aid in and KHTK AM. The Hold Separate also would not switch enough purchases of evaluating radio audiences. DMAs are advertising time to radio stations requires defendants to take certain steps widely accepted by radio stations, to ensure that the Divestiture Stations located outside the Divestiture Markets, advertisers, and advertising agencies as to other media, including digital music are operated as competitively the standard geographic area to use in independent, economically viable and services, like Pandora, that offer evaluating radio audience size and advertising time, or to non-English- ongoing business concerns, demographic composition (primarily uninfluenced by Entercom, so that language stations to render the price age and gender). A radio station’s increase unprofitable. competition is maintained until the advertising rates typically are based on In addition, radio stations negotiate required divestitures occur. the station’s ability, relative to prices individually with advertisers; competing radio stations, to attract The United States and defendants consequently, radio stations can charge listening audiences that have certain have stipulated that the proposed Final different advertisers different prices. Judgment may be entered after demographic characteristics that advertisers want to reach. Radio stations generally can identify compliance with the APPA. Entry of the advertisers with strong preferences to proposed Final Judgment would Entercom and CBS broadcast radio stations generate most of their revenues advertise on radio in a specific language terminate this action, except that the by selling English-language advertising and in a specific DMA. Because of this Court would retain jurisdiction to time in particular DMAs to local and ability to price discriminate among construe, modify, or enforce the national advertisers. Advertising placed customers, radio stations may charge provisions of the proposed Final on radio stations in a DMA is aimed at higher prices to advertisers that view Judgment and to punish violations reaching listening audiences located in radio in a specific DMA as particularly thereof. that DMA, and broadcast radio stations effective for their needs, while maintaining lower prices for more price- II. DESCRIPTION OF THE EVENTS outside that DMA do not provide sensitive advertisers in that same DMA. GIVING RISE TO THE ALLEGED effective access to those audiences. As a result, Entercom and CBS could VIOLATION Many local and national advertisers purchase radio advertising time because profitably raise prices to those A. The Defendants and the Proposed they find such advertising valuable, advertisers that view broadcast radio Acquisition either by itself or as part of a mix of that targets listeners in the Divestiture media platforms, including television, Markets as an important advertising Entercom is incorporated in digital music services, like Pandora medium. Pennsylvania and headquartered in Bala Media, Inc. (‘‘Pandora’’), and other 2. Harm to Competition Cynwyd, Pennsylvania. Entercom owns advertising platforms. For such and operates 126 broadcast radio advertisers, radio time (a) may be less The Complaint alleges that the stations in 28 metropolitan areas. expensive and more cost-efficient than proposed acquisition likely would CBS is organized under the laws of other media in reaching the advertiser’s lessen competition substantially in Delaware, with headquarters in New target audience (individuals most likely interstate trade and commerce, in York, New York. CBS owns and to purchase the advertiser’s products or violation of Section 7 of the Clayton operates 116 broadcast radio stations in services) at the desired frequency; or (b) Act, 15 U.S.C. 18, and likely would have 26 metropolitan areas. may offer promotional and on-air the following effects, among others: endorsement opportunities to a) Competition in the sale of Pursuant to an Agreement and Plan of advertisers that cannot be replicated as advertising time on English-language Merger, dated February 2, 2017, effectively using other media. For these broadcast radio stations in the Entercom agreed to acquire all of CBS’s and other reasons, many local and Divestiture Markets would be lessened broadcast radio stations. national advertisers who purchase radio substantially; Entercom and CBS compete against advertising time view radio as a b) competition between Entercom one another to win business from local necessary advertising medium for them broadcast radio stations and CBS and national advertisers that seek to or as an important part of advertising broadcast radio stations in the sale of purchase English-language radio campaigns that include other media radio advertising time in the Divestiture advertising time that targets listeners platforms. Markets would be eliminated; and located in certain DMAs. The proposed Many local and national advertisers c) the prices for advertising time on transaction between Entercom and CBS also consider English-language radio to English-language broadcast radio would eliminate that competition in the be particularly effective or important to stations in the Divestiture Markets likely Divestiture Markets. reach their desired customers. The would increase.
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In the Divestiture Markets, combining advertisers differing prices, but that respond with higher prices of their own, the Entercom and CBS broadcast radio ability is circumscribed in part by the rather than reposition their stations to stations would give Entercom the number and attractiveness of induce Entercom’s listeners and following estimated percentages of competitive radio stations and station advertisers to switch. Repositioning, by advertising sales on English-language groups in the market that can meet a changing a station’s format, is costly and broadcast radio stations: In Boston, over particular advertiser’s audience reach risky, with the potential to lose 50 percent; in San Francisco, over 40 and frequency needs. When such substantial numbers of existing listeners percent; and in Sacramento, over 55 competition exists, advertisers can and advertisers. In addition, percent. In addition, Entercom’s negotiate lower prices by ‘‘playing off’’ reformatting is unlikely to attract in a acquisition of CBS’s broadcast radio stations and station groups against each timely manner enough listeners or stations located in the Divestiture other. Entercom and CBS, each of which advertisers to make a price increase Markets would result in each operates highly-rated radio stations and unprofitable for Entercom. Finally, the Divestiture Market becoming highly clusters of stations in the Divestiture entry of new radio stations into the concentrated. Using the Herfindahl- Markets, are important competitors for Divestiture Markets would not be Hirschman Index (‘‘HHI’’), a standard listeners and advertisers in each of those timely, likely, or sufficient to deter the measure of market concentration,2 the markets. For many local and national exercise of market power. estimated post-acquisition HHIs and the advertisers buying radio advertising For all these reasons, the Complaint changes in those HHIs in each of the time in the Divestiture Markets, alleges that Entercom’s proposed Divestiture Markets based on revenues Entercom and CBS are two of a limited acquisition of CBS’ broadcast radio can be stated as follows: In Boston, the number of station groups whose large stations would lessen competition post-merger HHI would be over 3,600 and diverse listenership allows substantially in the sale of radio with an increase in the HHI of over advertisers to meet their reach and advertising time to advertisers targeting 1,200; in San Francisco, the post-merger frequency goals with respect to their listeners in each of the Divestiture HHI would be over 2,800 with an targeted audience. The transaction Markets, eliminate head-to-head increase of over 800; and in Sacramento, would end the head-to-head competition between Entercom and CBS the post-merger HHI would be over competition between Entercom and CBS broadcast radio stations in those three 4,300 with an increase of over 1,600. As station groups in each of the Divestiture markets, and result in increased prices can be seen, Entercom’s proposed Markets. for radio advertisers in those markets, acquisition of CBS’s broadcast radio In addition, the loss of head-to-head all in violation of Section 7 of the stations in the Divestiture Markets competition between specific Entercom Clayton Act. and CBS radio stations can exacerbate would result in substantial increases in III. EXPLANATION OF THE the harm to advertisers for whom those the HHIs of each market in excess of the PROPOSED FINAL JUDGMENT 200 points presumed likely to enhance stations are particularly close market power under the Horizontal substitutes. For example, in Boston, The proposed Final Judgment requires Merger Guidelines issued by the Entercom’s WEEI FM, which broadcasts significant divestitures that will Department of Justice and Federal Trade in a sports talk format, is a close eliminate the anticompetitive effects of Commission. substitute for CBS’s WBZ FM, which the transaction in the Divestiture The transaction also combines also broadcasts in a sports talk format. Markets by maintaining the Divestiture stations that are close substitutes and Both stations are among the highest- Stations as independent, economically vigorous head-to-head competitors for rated in Boston. They share many of the viable competitors. The proposed Final advertisers seeking to reach audiences same listeners and have audiences with Judgment requires Entercom to divest in the Divestiture Markets. Advertisers very similar demographic characteristics the Boston broadcast radio stations WBZ select radio stations to reach a large that are valuable to many advertisers. AM, WRKO AM, WZLX FM, and WKAF percentage of their target audience Prior to the transaction, if Entercom had FM to iHeartMedia, and WBZ FM to based upon a number of factors, increased prices for advertising time on Beasley Broadcasting. The proposed including, inter alia, the size of the WEEI FM, it likely would have lost Final Judgment also requires Entercom station’s audience, the demographic sufficient revenues and profits to CBS’s to place certain broadcast radio stations characteristics of its audience, and the WBZ FM to outweigh the gain from into a trust to be operated independent geographic reach of a station’s broadcast customers willing to accept the price from and in competition with Entercom: signal. Many advertisers seek to reach a increase. Following the transaction, In San Francisco, KOIT FM, KMVQ FM, large percentage of their target listeners however, it would recapture the KUFX FM, and KBLX FM; and in by selecting those stations whose revenues and profits from those Sacramento, KNCI FM, KYMX FM, audience best correlates to their target advertisers switching to WBZ FM KZZO FM, and KHTK AM. With respect listeners. As stated above, radio stations because of a WEEI FM price increase. As to those stations, the proposed Final have the ability to charge different a consequence, the transaction would Judgment provides that Entercom can make such a price increase profitable. enter into local marketing agreement(s) 2 See U.S. Dep’t of Justice, Horizontal Merger Entercom could also effect this strategy (‘‘LMAs’’) with Bonneville Guidelines § 5.3 (2010), available at http:// by increasing WBZ FM’s prices, which International. During the term of the www.justice.gov/atr/public/guidelines/hmg- LMAs, Bonneville will program each of 2010.html. The HHI is calculated by squaring the could be recaptured to some extent market share of each firm competing in the market through increased WEEI FM’s sales. those radio stations as an independent, and then summing the resulting numbers. For Therefore, Entercom likely would raise ongoing, economically viable, example, for a market consisting of four firms with advertising prices as a result of the competitive business, with shares of 30, 30, 20, and 20 percent, the HHI is programming and advertising sales of 2,600 (302 + 302 + 202 + 202 = 2,600). It approaches transaction. zero when a market is occupied by a large number Post-acquisition, if Entercom raised each station held entirely separate, of firms of relatively equal size and reaches a prices to those advertisers that buy distinct, and apart from those of maximum of 10,000 points when a market is advertising time on the Entercom and defendants’ other operations. The LMAs controlled by a single firm. The HHI increases both CBS broadcast radio stations in the cannot be amended without the prior as the number of firms in the market decreases and as the disparity in size between those firms Divestiture Markets, non-Entercom approval of the United States at its sole increases. stations in those markets would likely discretion. Each LMA will expire with
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respect to each LMA station upon the conduct other business negotiations describing his or her efforts to consummation of a final agreement to jointly with the acquirer(s) with respect accomplish the divestiture of any divest that station to an acquirer. The to the Divestiture Assets, or providing remaining stations. If the divestiture has United States has approved iHeartMedia financing or guarantees of financing not been accomplished after six (6) and Beasley as divestiture buyers in with respect to the Divestiture Assets, months, the trustee and the United Boston, and has approved the LMAs during the term of this Final Judgment. States will make recommendations to with Bonneville. The shared services prohibition does the Court, which shall enter such orders The divestitures target the loss of not preclude defendants from as appropriate, to carry out the purpose competition between Entercom and CBS continuing or entering into any non- of the trust, including extending the in each of the Divestiture Markets. sales-related shared services agreement trust or the term of the trustee’s Because of the unique positioning of that is approved in advance by the appointment. radio stations in Boston, the divestitures United States in its sole discretion. The IV. REMEDIES AVAILABLE TO will strengthen the ability of each of the time brokerage agreement prohibition POTENTIAL PRIVATE LITIGANTS remaining major station groups to offer does not preclude defendants from a wider range of attractive demographics entering into an agreement pursuant to Section 4 of the Clayton Act, 15 to advertisers that seek to target specific which the acquirers can begin U.S.C. § 15, provides that any person demographic groups of listeners on programming the Divestiture Stations who has been injured as a result of English-language broadcast radio immediately after the Court’s approval conduct prohibited by the antitrust laws stations in the Boston market. Further, of the Hold Separate Stipulation and may bring suit in federal court to the divestiture of WBZ FM to Beasley Order in this matter, so long as any recover three times the damages the Broadcasting preserves the competition agreement with an acquirer expires person has suffered, as well as costs and for advertisers and listeners between the upon the consummation of a final reasonable attorneys’ fees. Entry of the two important sports radio stations, agreement to divest the Divestiture proposed Final Judgment will neither WEEI FM and WBZ FM. Assets to the acquirer. impair nor assist the bringing of any In San Francisco, the divestitures Defendants are required to take all private antitrust damage action. Under prevent any significant lessening of steps reasonably necessary to the provisions of Section 5(a) of the competition in the San Francisco accomplish the divestiture quickly and Clayton Act, 15 U.S.C. § 16(a), the broadcast radio market. to cooperate with prospective proposed Final Judgment has no prima In Sacramento, the divestitures purchasers. Because transferring the facie effect in any subsequent private prevent any significant lessening of broadcast license for each of the lawsuit that may be brought against competition in the Sacramento Divestiture Stations requires FCC defendants. broadcast radio market. approval, defendants are specifically V. PROCEDURES AVAILABLE FOR The ‘‘Divestiture Assets’’ are defined required to use their best efforts to in Paragraph II.I of the proposed Final MODIFICATION OF THE PROPOSED obtain all necessary FCC approvals as FINAL JUDGMENT Judgment to cover all assets, tangible or expeditiously as possible. The intangible, necessary for the operation divestiture of each of the Divestiture The United States and defendants of the Divestiture Stations as viable, Stations must occur within ninety (90) have stipulated that the proposed Final ongoing commercial broadcast radio calendar days after the filing of the Hold Judgment may be entered by the Court stations. With respect to each Separate Stipulation and Order in this after compliance with the provisions of Divestiture Station, the divestiture will matter or five (5) calendar days after the APPA, provided that the United include assets sufficient to satisfy the notice of the entry of the Final Judgment States has not withdrawn its consent. United States, in its sole discretion, that by the Court, whichever is later, subject The APPA conditions entry upon the such assets can and will be used to to extension during the pendency of any Court’s determination that the proposed operate each station as a viable, necessary FCC order pertaining to the Final Judgment is in the public interest. ongoing, commercial radio business. divestiture. The United States, in its The APPA provides a period of at To ensure that the Divestiture Stations sole discretion, may agree to one or least sixty (60) days preceding the are operated independently from more extensions of the ninety-day time effective date of the proposed Final Entercom after the divestiture, Section V period not to exceed ninety (90) Judgment within which any person may and Section XII of the proposed Final calendar days in total, and shall notify submit to the United States written Judgment prohibit Entercom from the Court in such circumstances. comments regarding the proposed Final entering into any agreements during the In the event that defendants do not Judgment. Any person who wishes to term of the Final Judgment that create accomplish the divestitures within the comment should do so within sixty (60) a long-term relationship with or any periods prescribed in the proposed days of the date of publication of this entanglements that affect competition Final Judgment, the proposed Final Competitive Impact Statement in the between either Entercom and the Judgment provides that the Court, upon Federal Register, or the last date of acquirers of the Divestiture Stations application of the United States, will publication in a newspaper of the concerning the Divestiture Assets after appoint a trustee selected by the United summary of this Competitive Impact the divestiture is completed. Examples States to effect the divestitures. If a Statement, whichever is later. All of prohibited agreements include trustee is appointed, the proposed Final comments received during this period agreements to reacquire any part of the Judgment provides that Entercom will will be considered by the United States Divestiture Assets, agreements to pay all costs and expenses of the trustee. Department of Justice, which remains acquire any option to reacquire any part The trustee’s commission will be free to withdraw its consent to the of the Divestiture Assets or to assign the structured to provide an incentive for proposed Final Judgment at any time Divestiture Assets to any other person, the trustee based on the price obtained prior to the Court’s entry of judgment. agreements to enter into any time and the speed with which the The comments and the response of the brokerage agreement, local marketing divestiture is accomplished. After his or United States will be filed with the agreement, joint sales agreement, other her appointment becomes effective, the Court. In addition, comments will be cooperative selling arrangement, shared trustee will file monthly reports with posted on the United States Department services agreement, or agreements to the Court and the United States of Justice, Antitrust Division’s Internet
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website and, under certain markets, upon the public generally and [t]he balancing of competing social and circumstances, published in the Federal individuals alleging specific injury from the political interests affected by a proposed Register. violations set forth in the complaint antitrust consent decree must be left, in the Written comments should be including consideration of the public benefit, first instance, to the discretion of the if any, to be derived from a determination of Attorney General. The court’s role in submitted to: Owen M. Kendler, Chief, the issues at trial. protecting the public interest is one of Media, Entertainment, and Professional 15 U.S.C. § 16(e)(1)(A) & (B). In insuring that the government has not Services Section, Antitrust Division, breached its duty to the public in consenting United States Department of Justice, 450 considering these statutory factors, the to the decree. The court is required to 5th Street, N.W. Suite 4000, court’s inquiry is necessarily a limited determine not whether a particular decree is Washington, DC 20530. one as the government is entitled to the one that will best serve society, but The proposed Final Judgment ‘‘broad discretion to settle with the whether the settlement is ‘‘within the reaches provides that the Court retains defendant within the reaches of the of the public interest.’’ More elaborate jurisdiction over this action, and public interest.’’ United States v. requirements might undermine the Microsoft Corp., 56 F.3d 1448, 1461 effectiveness of antitrust enforcement by defendants may apply to the Court for consent decree. any order necessary or appropriate for (D.C. Cir. 1995); see generally United the modification, interpretation, or States v. SBC Commc’ns, Inc., 489 F. Bechtel, 648 F.2d at 666 (emphasis 4 enforcement of the Final Judgment. Supp. 2d 1 (D.D.C. 2007) (assessing added) (citations omitted). In public interest standard under the determining whether a proposed VI. ALTERNATIVES TO THE Tunney Act); United States v, U.S. settlement is in the public interest, a PROPOSED FINAL JUDGMENT Airways Group, Inc., No. 13–cv–1236 district court ‘‘must accord deference to The United States considered, as an (CKK), 2014–1 Trade Cas. (CCH) ¶ 78, the government’s predictions about the alternative to the proposed Final 748, 2014 U.S. Dist. LEXIS 57801, at *7 efficacy of its remedies, and may not Judgment, a full trial on the merits (D.D.C. Apr. 25, 2014) (noting the court require that the remedies perfectly against defendants. The United States has broad discretion of the adequacy of match the alleged violations.’’ SBC could have continued the litigation and the relief at issue); United States v. Commc’ns, 489 F. Supp. 2d at 17; see sought preliminary and permanent InBev N.V./S.A., No. 08-1965 (JR), also U.S. Airways, 2014 U.S. Dist. LEXIS injunctions against Entercom’s 2009-2 Trade Cas. (CCH) ¶ 76,736, 2009 57801, at *16 (noting that a court should acquisition of CBS’s broadcast radio U.S. Dist. LEXIS 84787, at *3, (D.D.C. not reject the proposed remedies stations. The United States is satisfied, Aug. 11, 2009) (noting that the court’s because it believes others are however, that the divestiture of assets review of a consent judgment is limited preferable); Microsoft, 56 F.3d at 1461 described in the proposed Final and only inquires ‘‘into whether the (noting the need for courts to be Judgment will preserve competition for government’s determination that the ‘‘deferential to the government’s the sale of broadcast radio advertising in proposed remedies will cure the predictions as to the effect of the the Boston, San Francisco, and antitrust violations alleged in the proposed remedies’’); United States v. Sacramento DMAs. Thus, the proposed complaint was reasonable, and whether Archer-Daniels-Midland Co., 272 F. Final Judgment would achieve all or the mechanism to enforce the final Supp. 2d 1, 6 (D.D.C. 2003) (noting that 3 substantially all of the relief the United judgment are clear and manageable.’’). the court should grant due respect to the States would have obtained through As the United States Court of Appeals United States’ prediction as to the effect litigation, but avoids the time, expense, for the District of Columbia Circuit has of proposed remedies, its perception of and uncertainty of a full trial on the held, under the APPA a court considers, the market structure, and its views of merits of the Complaint. among other things, the relationship the nature of the case). between the remedy secured and the Courts have greater flexibility in VII. STANDARD OF REVIEW UNDER specific allegations set forth in the approving proposed consent decrees THE APPA FOR THE PROPOSED government’s complaint, whether the than in crafting their own decrees FINAL JUDGMENT decree is sufficiently clear, whether following a finding of liability in a The Clayton Act, as amended by the enforcement mechanisms are sufficient, litigated matter. ‘‘[A] proposed decree APPA, requires that proposed consent and whether the decree may positively must be approved even if it falls short judgments in antitrust cases brought by harm third parties. See Microsoft, 56 of the remedy the court would impose the United States be subject to a sixty- F.3d at 1458-62. With respect to the on its own, as long as it falls within the day comment period, after which the adequacy of the relief secured by the range of acceptability or is ‘within the court shall determine whether entry of decree, a court may not ‘‘engage in an reaches of public interest.’’’ United the proposed Final Judgment ‘‘is in the unrestricted evaluation of what relief States v. Am. Tel. & Tel. Co., 552 F. public interest.’’ 15 U.S.C. § 16(e)(1). In would best serve the public.’’ United Supp. 131, 151 (D.D.C. 1982) (citations making that determination, the court, in States v. BNS, Inc., 858 F.2d 456, 462 omitted) (quoting United States v. accordance with the statute as amended (9th Cir. 1988) (quoting United States v. Gillette Co., 406 F. Supp. 713, 716 (D. in 2004, is required to consider: Bechtel Corp., 648 F.2d 660, 666 (9th Mass. 1975)), aff’d sub nom. Maryland Cir. 1981)); see also Microsoft, 56 F.3d (A) the competitive impact of such v. United States, 460 U.S. 1001 (1983); at 1460-62; United States v. Alcoa, Inc., see also U.S. Airways, 2014 U.S. Dist. judgment, including termination of alleged 152 F. Supp. 2d 37, 40 (D.D.C. 2001); violations, provisions for enforcement and modification, duration of relief sought, InBev, 2009 U.S. Dist. LEXIS 84787, at 4 Cf. BNS, 858 F.2d at 464 (holding that the anticipated effects of alternative remedies *3. Courts have held that: court’s ‘‘ultimate authority under the [APPA] is actually considered, whether its terms are limited to approving or disapproving the consent ambiguous, and any other competitive 3 The 2004 amendments substituted ‘‘shall’’ for decree’’); United States v. Gillette Co., 406 F. Supp. considerations bearing upon the adequacy of ‘‘may’’ in directing relevant factors for court to 713, 716 (D. Mass. 1975) (noting that, in this way, such judgment that the court deems consider and amended the list of factors to focus on the court is constrained to ‘‘look at the overall picture not hypercritically, nor with a microscope, necessary to a determination of whether the competitive considerations and to address potentially ambiguous judgment terms. Compare 15 but with an artist’s reducing glass’’). See generally consent judgment is in the public interest; U.S.C. § 16(e) (2004) with 15 U.S.C. § 16(e)(1) Microsoft, 56 F.3d at 1461 (discussing whether ‘‘the and (2006); see also SBC Commc’ns, 489 F. Supp. 2d at remedies [obtained in the decree are] so (B) the impact of entry of such judgment 11 (concluding that the 2004 amendments ‘‘effected inconsonant with the allegations charged as to fall upon competition in the relevant market or minimal changes’’ to Tunney Act review). outside of the ‘reaches of the public interest’’’).
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LEXIS 57801, at *8 (noting that room The language wrote into the statute PROPOSED FINAL JUDGMENT must be made for the government to what Congress intended when it enacted WHEREAS, Plaintiff, United States of grant concessions in the negotiation the Tunney Act in 1974, as Senator America, filed its Complaint on process for settlements (citing Microsoft, Tunney explained: ‘‘[t]he court is November 1, 2017, the United States 56 F.3d at 1461)); United States v. Alcan nowhere compelled to go to trial or to and defendants Entercom Aluminum Ltd., 605 F. Supp. 619, 622 engage in extended proceedings which Communications Corp. and CBS (W.D. Ky. 1985) (approving the consent might have the effect of vitiating the Corporation, by their respective decree even though the court would benefits of prompt and less costly attorneys, have consented to the entry of have imposed a greater remedy). To settlement through the consent decree this Final Judgment without trial or meet this standard, the United States process.’’ 119 Cong. Rec. 24,598 (1973) adjudication of any issue of fact or law, ‘‘need only provide a factual basis for (statement of Senator Tunney). Rather, and without this Final Judgment concluding that the settlements are the procedure for the public interest constituting any evidence against or reasonably adequate remedies for the determination is left to the discretion of admission by any party regarding any alleged harms.’’ SBC Commc’ns, 489 F. the court, with the recognition that the issue of fact or law; Supp. 2d at 17. court’s ‘‘scope of review remains AND WHEREAS, defendants agree to Moreover, the court’s role under the sharply proscribed by precedent and the APPA is limited to reviewing the be bound by the provisions of this Final nature of Tunney Act proceedings.’’ Judgment pending its approval by the remedy in relationship to the violations 5 SBC Commc’ns, 489 F. Supp. 2d at 11. Court; that the United States has alleged in its A court can make its public interest Complaint, and does not authorize the AND WHEREAS, the essence of this determination based on the competitive Final Judgment is the prompt and court to ‘‘construct [its] own impact statement and response to public hypothetical case and then evaluate the certain divestiture of certain rights or comments alone. U.S. Airways, 2014 assets by the defendants to assure that decree against that case.’’ Microsoft, 56 U.S. Dist. LEXIS 57801, at *9. F.3d at 1459; see also U.S. Airways, competition is not substantially 2014 U.S. Dist. LEXIS 57801, at *9 VIII. DETERMINATIVE DOCUMENTS lessened; (noting that the court must simply AND WHEREAS, the United States determine whether there is a factual There are no determinative materials requires defendants to make certain foundation for the government’s or documents within the meaning of the divestitures for the purpose of decisions such that its conclusions APPA that were considered by the remedying the loss of competition regarding the proposed settlements are United States in formulating the alleged in the Complaint; reasonable); InBev, 2009 U.S. Dist. proposed Final Judgment. AND WHEREAS, defendants have LEXIS 84787, at *20 (‘‘the ‘public Dated: November 1, 2017 represented to the United States that the interest’ is not to be measured by Respectfully Submitted, divestitures required below can and will comparing the violations alleged in the /s/ be made, and that defendants will later complaint against those the court Bennett J. Matelson* lllllllllll raise no claim of hardship or difficulty believes could have, or even should Mark A. Merva as grounds for asking the Court to have, been alleged’’). Because the Trial Attorneys modify any of the divestiture provisions ‘‘court’s authority to review the decree United States Department of Justice, contained below; depends entirely on the government’s Antitrust Division Media, Entertainment and NOW THEREFORE, before any exercising its prosecutorial discretion by Professional Services Section, 450 Fifth testimony is taken, without trial or bringing a case in the first place,’’ it Street NW, Suite 4000, Washington, DC adjudication of any issue of fact or law, follows that ‘‘the court is only 20530, Tel: (202) 616–5871, Fax: (202) 514– and upon consent of the parties, it is authorized to review the decree itself,’’ 7308, Email: [email protected] ORDERED, ADJUDGED, AND and not to ‘‘effectively redraft the * Attorney of Record DECREED: complaint’’ to inquire into other matters I. Jurisdiction that the United States did not pursue. United States District Court for the Microsoft, 56 F.3d at 1459-60. As this District of Columbia This Court has jurisdiction over the Court recently confirmed in SBC United States of America, Plaintiff, v. subject matter of and each of the parties Communications, courts ‘‘cannot look Entercom Communications Corp. and CBS to this action. The Complaint states a beyond the complaint in making the Corporation, Defendants. claim upon which relief may be granted against defendants under Section 7 of public interest determination unless the Case No: 1:17–cv–02268 complaint is drafted so narrowly as to Judge: Boasberg the Clayton Act, as amended (15 U.S.C. make a mockery of judicial power.’’ SBC § 18). Commc’ns, 489 F. Supp. 2d at 15. 5 See United States v. Enova Corp., 107 F. Supp. II. Definitions In its 2004 amendments, Congress 2d 10, 17 (D.D.C. 2000) (noting that the ‘‘Tunney made clear its intent to preserve the Act expressly allows the court to make its public As used in this Final Judgment: practical benefits of utilizing consent interest determination on the basis of the A. ‘‘Entercom’’ means defendant decrees in antitrust enforcement, adding competitive impact statement and response to Entercom Communications Corp., a comments alone’’); United States v. Mid-Am. the unambiguous instruction that Dairymen, Inc., 1977-1 Trade Cas. (CCH) ¶ 61,508, Pennsylvania corporation headquartered ‘‘[n]othing in this section shall be at 71,980 (W.D. Mo. 1977) (‘‘Absent a showing of in Bala Cynwyd, Pennsylvania, its construed to require the court to corrupt failure of the government to discharge its successors and assigns, and its conduct an evidentiary hearing or to duty, the Court, in making its public interest subsidiaries, divisions, groups, finding, should . . . carefully consider the require the court to permit anyone to explanations of the government in the competitive affiliates, partnerships, and joint intervene.’’ 15 U.S.C. § 16(e)(2); see also impact statement and its responses to comments in ventures, and their directors, officers, U.S. Airways, 2014 U.S. Dist. LEXIS order to determine whether those explanations are managers, agents, and employees. 57801, at *9 (indicating that a court is reasonable under the circumstances.’’); S. Rep. No. B. ‘‘CBS’’ means defendant CBS 93-298, 93d Cong., 1st Sess., at 6 (1973) (‘‘Where not required to hold an evidentiary the public interest can be meaningfully evaluated Corporation, a Delaware corporation hearing or to permit intervenors as part simply on the basis of briefs and oral arguments, headquartered in New York City, New of its review under the Tunney Act). that is the approach that should be utilized.’’). York, its successors and assigns, and its
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subsidiaries, including CBS Radio, Inc., a. WRKO AM, located in the Boston, of lesser business units that include the divisions, groups, affiliates, Massachusetts DMA (‘‘WRKO AM’’); Divestiture Assets, defendants shall partnerships, and joint ventures, and b. WKAF FM, located in the Boston, require the purchaser to be bound by the their directors, officers, managers, Massachusetts DMA (‘‘WKAF FM’’); provisions of this Final Judgment. agents, and employees. c. KOIT FM, located in the San Entercom need not obtain such an C. ‘‘Acquirers’’ means Beasley, Francisco, California DMA (‘‘KOIT FM’’) agreement from the acquirers of the iHeartMedia, or another entity to which d. KUFX FM, located in the San assets divested pursuant to this Final Entercom divests any Divestiture Assets. Francisco, California DMA (‘‘KUFX Judgment. D. ‘‘Beasley’’ means Beasley Broadcast FM’’); and Group, Inc., a Delaware Corporation, e. KBLX FM, located in the San IV. LMA headquartered in Naples, Florida, its Francisco, California DMA (‘‘KBLX Entercom is ordered and directed, successor and assigns, and its FM’’). after the Court’s approval of the Hold subsidiaries, divisions, groups, 3. All of the assets, tangible or Separate Stipulation and Order in this affiliates, partnerships, and joint intangible, necessary for the operations matter, to enter into an LMA(s) with ventures, and their directors, officers, of the Divestiture Radio Stations and respect to the LMA Radio Stations with managers, agents, and employees. LMA Radio Stations as viable, ongoing Bonneville, the terms of which are E. ‘‘Bonneville’’ means Bonneville commercial broadcast radio stations, subject to the approval of the United International Corporation, except as otherwise agreed to in writing States in its sole discretion. Pursuant to headquartered in Salt Lake City, Utah, by the United States Department of the terms of the LMA(s), Entercom will its successor and assigns, and its Justice, including, but not limited to, all cede to Bonneville the sole right and subsidiaries, divisions, groups, real property (owned or leased), all ability to program and sell advertising affiliates, partnerships, and joint broadcast equipment, office equipment, on the LMA Radio Stations. The LMA(s) ventures, and their directors, officers, office furniture, fixtures, materials, shall last no longer than one year or, managers, agents, and employees. supplies, and other tangible property; with respect to each LMA Radio Station, F. ‘‘iHeartMedia’’ means iHeartMedia, all licenses, permits, authorizations, and upon the consummation of a final Inc., a Delaware Corporation, applications therefore issued by the agreement to divest that station to an headquartered in San Antonio, Texas, Federal Communications Commission Acquirer. Without limiting defendants’ its successor and assigns, and its (‘‘FCC’’) and other government agencies obligations under Section IX, Bonneville subsidiaries, divisions, groups, related to the stations; all contracts will program each of those radio affiliates, partnerships, and joint (including programming contracts and stations as an independent, ongoing, ventures, and their directors, officers, rights), agreements, network economically viable, competitive managers, agents, and employees. agreements, leases, and commitments business, with programming and G. ‘‘DMA’’ means Designated Market and understandings of defendants; all advertising sales held entirely separate, Area as defined by A.C. Nielsen trademarks, service marks, trade names, distinct, and apart from those of Company and used by the Investing in copyrights, patents, slogans, defendants’ other operations. Entercom Radio BIA Market Report 2016 (1st programming materials, and and Bonneville may not amend the edition). DMAs are ranked according to promotional materials relating to the LMA(s) without the prior approval of the number of households therein and stations (subject to the CBS Brands the United States, in its sole discretion. are used by broadcasters, advertisers, License Agreements contained in the V. Divestitures and advertising agencies to aid in Agreement and Plan of Merger, dated evaluating radio audience size and February 2, 2017, between CBS, CBS A. Entercom is ordered and directed, composition. Radio, Inc., and Entercom); all customer within ninety (90) calendar days after H. ‘‘LMA’’ means a local marketing lists, contracts, accounts, credit records, the signing of the Hold Separate agreement. and all logs and other records Stipulation and Order in this matter or I. ‘‘Divestiture Assets’’ means five (5) calendar days after notice of the 1. The following broadcast radio maintained by defendants in connection with the stations. entry of this Final Judgment by the stations owned by CBS: Court, whichever is later, to divest the a. WBZ AM, located in the Boston, J. ‘‘Divestiture Radio Stations’’ means WBZ AM, WBZ FM, WRKO AM, WKAF Divestiture Radio Stations in a manner Massachusetts DMA (‘‘WBZ AM’’); consistent with this Final Judgment to b. WBZ FM, located in the Boston, FM and WZLX FM. an Acquirer or Acquirers acceptable to Massachusetts DMA (‘‘WBZ FM’’); K. ‘‘LMA Radio Stations’’ means KOIT the United States, in its sole discretion. c. WZLX FM, located in the Boston, FM, KMVQ FM, KUFX FM, KBLX FM, Massachusetts DMA (‘‘WZLX FM’’); KNCI FM, KYMX FM, KZZO FM and The United States, in its sole discretion, d. KMVQ FM, located in the San KHTK AM. may agree to one or more extensions of Francisco, California DMA (‘‘KMVQ L. ‘‘Relevant Employee’’ means the this time period not to exceed ninety FM’’); personnel involved in the operations of (90) calendar days in total, and shall e. KNCI FM, located in the the Divestiture Assets. notify the Court in such circumstances. B. Entercom is ordered and directed, Sacramento, California DMA (‘‘KNCI III. Applicability FM’’); within one hundred and eighty (180) f. KYMX FM, located in the A. This Final Judgment applies to calendar days after the signing of the Sacramento, California DMA (‘‘KYMX Entercom and CBS as defined above, Hold Separate Stipulation and Order in FM’’); and all other persons in active concert this matter, to divest the LMA Radio g. KZZO FM, located in the or participation with any of them who Stations in a manner consistent with Sacramento, California DMA (‘‘KZZO receive actual notice of this Final this Final Judgment to an Acquirer or FM’’); and Judgment by personal service or Acquirers acceptable to the United h. KHTK AM, located in the otherwise. States, in its sole discretion. The United Sacramento, California DMA (‘‘KHTK B. If, prior to complying with Section States, in its sole discretion, may agree AM’’). V and Section VI of this Final Judgment, to one or more extensions of this time 2. The following broadcast radio defendants sell or otherwise dispose of period not to exceed one hundred and stations owned by Entercom: all or substantially all of their assets or eighty (180) calendar days in total, and
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shall notify the Court in such employment. Defendants will not Judgment and remedy the competitive circumstances. interfere with any negotiations by the harm alleged in the Complaint. The C. With respect to divestiture of the Acquirer(s) to employ any defendant divestitures, whether pursuant to Divestiture Assets by Entercom or the employee whose primary responsibility Section V or Section VI of this Final trustee appointed pursuant to Section VI is the operation or management of the Judgment: of this Final Judgment, if applications Divestiture Assets. (1) shall be made to Acquirers that, in have been filed with the FCC within the G. From the date of the filing of the the United States’ sole judgment, has period permitted for divestiture, seeking Complaint in this matter, defendants the intent and capability (including the approval to assign or transfer licenses to may enter into an agreement with an necessary managerial, operational, the Acquirer(s) of the Divestiture Assets, Acquirer or Bonneville pursuant to technical, and financial capability) of but no order or other dispositive action which defendants may not solicit to competing effectively in the commercial by the FCC on such applications has hire, or hire, certain Relevant radio broadcasting business; and been issued before the end of the period Employees. Any such agreement is (2) shall be accomplished so as to permitted for divestiture, the period subject to the approval of the United satisfy the United States, in its sole permitted for divestiture shall be States, in its sole discretion. discretion, that none of the terms of any extended no later than ten (10) business H. Entercom shall permit prospective agreement between an Acquirer and days after the FCC order consenting to acquirers of the Divestiture Assets to defendants gives defendants the ability the assignment of the Divestiture Assets have reasonable access to personnel and unreasonably to raise any Acquirer’s to the Acquirers has become final. to make inspections of the physical costs, to lower any Acquirer’s efficiency, D. Entercom shall use its best efforts facilities of each of the Divestiture Radio or otherwise to interfere in the ability of to accomplish the divestitures ordered Stations; access to any and all any Acquirer to compete effectively. environmental, zoning, and other permit by this Final Judgment as expeditiously VI. Appointment of Divestiture Trustee as possible, including using their best documents and information; and access efforts to obtain all necessary FCC to any and all financial, operational, or A. If defendants have not divested approvals as expeditiously as possible. other documents and information each of the Divestiture Radio Stations This Final Judgment does not limit the customarily provided as part of a due within the time period specified in FCC’s exercise of its regulatory powers diligence process. Section V(A) or each of the LMA Radio and process with respect to the I. Entercom shall warrant to the Stations within the time period Divestiture Assets. Authorization by the Acquirer(s) that each Divestiture Radio specified in Section V(B), defendants FCC to conduct the divestiture of a Station or LMA Radio Station will be shall notify the United States of that fact Divestiture Asset in a particular manner operational on the date of sale. in writing. Upon application of the will not modify any of the requirements J. Defendants shall not take any action United States, the Court shall appoint a of this Final Judgment. that will impede in any way the Divestiture Trustee selected by the E. In the event that Entercom is permitting, operation, or divestiture of United States and approved by the attempting to divest any of the each of the Divestiture Radio Stations or Court to effect the divestiture of the Divestiture Assets to an Acquirer other LMA Radio Stations. Divestiture Assets. than Beasley (WBZ FM) or iHeartMedia K. Entercom shall warrant to the B. After the appointment of a (WBZ AM, WRKO AM, WKAF FM, and Acquirers that there are no material Divestiture Trustee becomes effective, WZLX FM): defects in the environmental, zoning, or only the Divestiture Trustee shall have (1) Entercom promptly shall make other permits pertaining to the the right to sell the Divestiture Assets. known, by usual and customary means, operation of each Divestiture Radio The Divestiture Trustee shall have the the availability of the Divestiture Assets; Station or LMA Radio Station, and that, power and authority to accomplish the (2) Entercom shall inform any person following the sale of each of the divestiture to an Acquirer(s) acceptable making inquiry regarding a possible Divestiture Assets, defendants will not to the United States at such price and purchase of the Divestiture Assets that undertake, directly or indirectly, any on such terms as are then obtainable they are being divested pursuant to this challenges to the environmental, zoning, upon reasonable effort by the Final Judgment and provide that person or other permits relating to the Divestiture Trustee, subject to the with a copy of this Final Judgment; operation of each Divestiture Radio provisions of Sections V, VI, and VII of (3) Except with written permission Station or LMA Radio Station. this Final Judgment, and shall have from the United States, Entercom shall L. Unless the United States otherwise such other powers as this Court deems offer to furnish to all prospective consents in writing, the divestiture appropriate. Subject to Section VI(D) of acquirers, subject to customary pursuant to Section V, or by Divestiture this Final Judgment, the Divestiture confidentiality assurances, all Trustee appointed pursuant to Section Trustee may hire at the cost and information and documents relating to VI of this Final Judgment, shall include expense of Entercom any investment the Divestiture Assets customarily the entire Divestiture Assets and shall bankers, attorneys, or other agents, who provided in a due diligence process be accomplished in such a way as to shall be solely accountable to the except such information or documents satisfy the United States, in its sole Divestiture Trustee, reasonably subject to the attorney-client privilege or discretion, that each Divestiture Radio necessary in the Divestiture Trustee’s work-product doctrine; and Station or LMA Radio Station can and judgment to assist in the divestiture. (4) Entercom shall make available will be used by the Acquirer(s) as part Any such investment bankers, attorneys, such information to the United States at of a viable, ongoing commercial radio or other agents shall serve on such terms the same time that such information is broadcasting business. Divestiture of the and conditions as the United States made available to any other person. Divestiture Assets may be made to one approves, including confidentiality F. Defendants shall provide the or more Acquirers, provided that in requirements and conflict of interest Acquirer(s) and the United States each instance it is demonstrated to the certifications. information relating to the personnel sole satisfaction of the United States C. Defendants shall not object to a sale necessary to the operation or that the Divestiture Assets will remain by the Divestiture Trustee on any management of the Divestiture Assets to viable, and the divestiture of such assets ground other than the Divestiture enable the Acquirer(s) to make offers of will achieve the purposes of this Final Trustee’s malfeasance. Any such
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objections by defendants must be action to interfere with or to impede the responsible for effecting the divestiture conveyed in writing to the United States Divestiture Trustee’s accomplishment of required herein, shall notify the United and the Divestiture Trustee within ten the divestitures. States of any proposed divestiture (10) calendar days after the Divestiture F. After its appointment, the required by Section V or Section VI of Trustee has provided the notice Divestiture Trustee shall file monthly this Final Judgment. If the Divestiture required under Section VII. reports with the United States and, as Trustee is responsible, it shall similarly D. The Divestiture Trustee shall serve appropriate, the Court setting forth the notify defendants. The notice shall set at the cost and expense of Entercom Divestiture Trustee’s efforts to forth the details of the proposed pursuant to a written agreement, on accomplish the divestitures ordered divestiture and list the name, address, such terms and conditions as the United under this Final Judgment. To the extent and telephone number of each person States approves, including such reports contain information that not previously identified who offered or confidentiality requirements and the Divestiture Trustee deems expressed an interest in or desire to conflict of interest certifications. The confidential, such reports shall not be acquire any ownership interest in the Divestiture Trustee shall account for all filed in the public docket of the Court. Divestiture Assets, together with full monies derived from the sale of the Such reports shall include the name, details of the same. assets sold by the Divestiture Trustee address, and telephone number of each B. Within fifteen (15) calendar days of and all costs and expenses so incurred. person who, during the preceding receipt by the United States of such After approval by the Court of the month, made an offer to acquire, notice, the United States may request Divestiture Trustee’s accounting, expressed an interest in acquiring, from defendants, the proposed including fees for its services yet unpaid entered into negotiations to acquire, or Acquirer(s), any other third party, or the and those of any professionals and was contacted or made an inquiry about Divestiture Trustee, if applicable, agents retained by the Divestiture acquiring, any interest in and of the additional information concerning the Trustee, all remaining money shall be Divestiture Radio Stations or LMA proposed divestiture(s), the proposed paid to Entercom and the trust shall Radio Stations, and shall describe in Acquirer(s), and any other potential then be terminated. The compensation detail each contact with any such Acquirer. Defendants and the of the Divestiture Trustee and any person. The Divestiture Trustee shall Divestiture Trustee shall furnish any professionals and agents retained by the maintain full records of all efforts made additional information requested within Divestiture Trustee shall be reasonable to divest the Divestiture Assets. fifteen (15) calendar days of the receipt in light of the value of the Divestiture G. If the Divestiture Trustee has not of the request, unless the parties shall Assets and based on a fee arrangement accomplished the divestitures ordered otherwise agree. providing the Divestiture Trustee with under this Final Judgment within six C. Within thirty (30) calendar days an incentive based on the price and months after its appointment, the after receipt of the notice or within terms of the divestiture and the speed Divestiture Trustee shall promptly file twenty (20) calendar days after the with which it is accomplished, but with the Court reports setting forth (1) United States has been provided the timeliness is paramount. If the the Divestiture Trustee’s efforts to additional information requested from Divestiture Trustee and Entercom are accomplish the required divestitures, (2) defendants, the proposed Acquirer(s), unable to reach agreement on the the reasons, in the Divestiture Trustee’s any third party, and the Divestiture Divestiture Trustee’s or any agents’ or judgment, why the required divestitures Trustee, whichever is later, the United consultants’ compensation or other have not been accomplished, and (3) the States shall provide written notice to terms and conditions of engagement Divestiture Trustee’s recommendations. defendants and the Divestiture Trustee, within 14 calendar days of appointment To the extent such reports contain if there is one, stating whether or not it of the Divestiture Trustee, the United information that the Divestiture Trustee objects to the proposed divestiture. If States may, in its sole discretion, take deems confidential, such reports shall the United States provides written appropriate action, including making a not be filed in the public docket of the notice that it does not object, the recommendation to the Court. The Court. The Divestiture Trustee shall at divestiture may be consummated, Divestiture Trustee shall, within three the same time furnish such reports to subject only to defendants’ limited right (3) business days of hiring any other the United States, which shall have the to object to the sale under Section VI(C) professionals or agents, provide written right to make additional of this Final Judgment. Absent written notice of such hiring and the rate of recommendations consistent with the notice that the United States does not compensation to Entercom and the purpose of the trust. The Court object to the proposed Acquirer(s) or United States. thereafter shall enter such orders as it upon objection by the United States, a E. Defendants shall use their best shall deem appropriate to carry out the divestiture proposed under Section V or efforts to assist the Divestiture Trustee purpose of the Final Judgment, which Section VI shall not be consummated. in accomplishing the required may, if necessary, include extending the Upon objection by defendants under divestitures. The Divestiture Trustee trust and the term of the Divestiture Section VI(C), a divestiture proposed and any consultants, accountants, Trustee’s appointment by a period under Section VI shall not be attorneys, and other agents retained by requested by the United States. consummated unless approved by the the Divestiture Trustee shall have full H. If the United States determines that Court. and complete access to the personnel, the Divestiture Trustee has ceased to act books, records, and facilities of the or failed to act diligently or in a VIII. Financing business to be divested, and defendants reasonably cost-effective manner, it may Defendants shall not finance all or shall develop financial and other recommend the Court appoint a any part of any purchase made pursuant information relevant to such business as substitute Divestiture Trustee. to Section V or Section VI of this Final the Divestiture Trustee may reasonably Judgment. request, subject to reasonable protection VII. Notice of Proposed Divestitures for trade secret or other confidential A. Within two (2) business days IX. Hold Separate research, development, or commercial following execution of a definitive Until the divestitures required by this information or any applicable divestiture agreement, Entercom or the Final Judgment have been privileges. Defendants shall take no Divestiture Trustee, whichever is then accomplished, defendants shall take all
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steps necessary to comply with the Hold after such divestiture has been pertinent page of such material, Separate Stipulation and Order entered completed. ‘‘Subject to claim of protection under by this Court. Defendants shall take no Rule 26(c)(1)(g) of the Federal Rules of XI. Compliance Inspection action that would jeopardize the Civil Procedure,’’ then the United States divestitures ordered by this Court. A. For the purposes of determining or shall give defendants ten (10) calendar securing compliance with this Final X. Affidavits days’ notice prior to divulging such Judgment, or of any related orders such material in any legal proceeding (other A. Within twenty (20) calendar days as the Hold Separate Stipulation and than a grand jury proceeding). of the filing of the Complaint in this Order, or of determining whether the matter, and every thirty (30) calendar Final Judgment should be modified or XII. No Reacquisition and Other days thereafter until the divestiture has vacated, and subject to any legally Prohibited Activities been completed under Section V or recognized privilege, from time to time Section VI, defendants shall deliver to authorized representatives of the United After the Divestiture Assets have been the United States an affidavit as to the States Department of Justice, including divested to Acquirers acceptable to the fact and manner of their compliance consultants and other persons retained United States in its sole discretion, and with Section V or Section VI of this by the United States, shall, upon written during the term of the Final Judgment: Final Judgment. Each such affidavit request of an authorized representative defendants may not (1) reacquire any shall include the name, address, and of the Assistant Attorney General in part of the Divestiture Assets, (2) telephone number of each person who, charge of the Antitrust Division, and on acquire any option to reacquire any part during the preceding thirty (30) reasonable notice to defendants, be of the Divestiture Assets or to assign the calendar days, made an offer to acquire, permitted: Divestiture Assets to any other person, expressed an interest in acquiring, (1) access during defendants’ office (3) enter into any time brokerage entered into negotiations to acquire, or hours to inspect and copy, or at the agreement, local marketing agreement, was contacted or made an inquiry about option of the United States, to require joint sales agreement, or other acquiring, any interest in any of the defendants to provide hard copy or cooperative selling arrangement with Divestiture Radio Stations, and shall electronic copies of, all books, ledgers, respect to the Divestiture Assets, or (4) describe in detail each contact with any accounts, records, data and documents provide financing or guarantees of such person during that period. Each in the possession, custody or control of financing with respect to the Divestiture such affidavit shall also include a defendants, relating to any matters Assets. Entercom may not enter into any description of the efforts defendants contained in this Final Judgment; and shared services agreement or conduct have taken to solicit buyers for and (2) to interview, either informally or other business negotiations jointly with complete the sale of each of the on the record, defendants’ officers, the Acquirer(s) with respect to the Divestiture Radio Stations, including employees, or agents, who may have Divestiture Assets. efforts to secure FCC or other regulatory their individual counsel present, The shared services prohibition does approvals, and to provide required regarding such matters. The interviews not preclude defendants from information to prospective acquirers, shall be subject to the reasonable continuing or entering into any non- including the limitations, if any, on convenience of the interviewee and sales-related shared services agreement such information. Assuming the without restraint or interference by that is approved in advance by the information set forth in the affidavit is defendants. United States in its sole discretion. true and complete, any objection by the B. Upon the written request of an If defendants reach an agreement to United States to information provided authorized representative of the divest the Divestiture Assets to the by defendants, including any limitations Assistant Attorney General in charge of Acquirers, defendants may also enter on information, shall be made within the Antitrust Division, defendants shall into an agreement, approved in advance fourteen (14) calendar days of receipt of submit written reports or responses to by the United States in its sole such affidavit. written interrogatories, under oath if B. Within twenty (20) calendar days requested, relating to any of the matters discretion, under which a defendant of the filing of the Complaint in this contained in this Final Judgment as may cedes to the Acquirer the sole right and matter, defendants shall deliver to the be requested. ability to program one or more of the United States an affidavit that describes C. No information or documents Divestiture Assets after the Court’s in reasonable detail all actions obtained by the means provided in this approval of the Hold Separate defendants have taken and all steps section shall be divulged by the United Stipulation and Order in this matter, defendants have implemented on an States to any person other than an provided that any such time brokerage ongoing basis to comply with Section IX authorized representative of the agreement must expire upon the of this Final Judgment. Each such executive branch of the United States, termination of a final agreement to affidavit shall also include a description except in the course of legal proceedings divest the Divestiture Assets to the of the efforts defendants have taken to to which the United States is a party Acquirer or upon the consummation of complete the sale of each of the (including grand jury proceedings), or a final agreement to divest the Divestiture Radio Stations, including for the purpose of securing compliance Divestiture Assets to the Acquirer. efforts to secure FCC or other regulatory with this Final Judgment, or as XIII. Retention of Jurisdiction approvals. Defendants shall deliver to otherwise required by law. the United States an affidavit describing D. If at the time information or This Court retains jurisdiction to any changes to the efforts and actions documents are furnished by defendants enable any party to this Final Judgment outlined in defendants’ earlier affidavits to the United States, defendants to apply to this Court at any time for filed pursuant to this section within represent and identify in writing the further orders and directions as may be fifteen (15) calendar days after the material in any such information or necessary or appropriate to carry out or change is implemented. documents to which a claim of construe this Final Judgment, to modify C. Defendants shall keep all records of protection may be asserted under Rule any of its provisions, to enforce all efforts made to preserve and divest 26(c)(1)(G) of the Federal Rules of Civil compliance, and to punish violations of the Divestiture Assets until one year Procedure, and defendants mark each its provisions.
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XIV. Enforcement of Final Judgment simultaneously with the Attorney Consortium (‘‘VSC8 Consortium’’) has The United States retains and reserves General and the Federal Trade filed written notifications all rights available to it under applicable Commission disclosing changes in its simultaneously with the Attorney law to enforce the provisions of this membership. The notifications were General and the Federal Trade Final Judgment, including its right to filed for the purpose of extending the Commission disclosing (1) the identities seek an order of contempt from this Act’s provisions limiting the recovery of of the parties to the venture and (2) the Court. Any civil contempt action, any antitrust plaintiffs to actual damages nature and objectives of the venture. motion to show cause, or any similar under specified circumstances. The notifications were filed for the action brought by the United States Specifically, WaveLink, Inc., Huntsville, purpose of invoking the Act’s provisions regarding an alleged violation of this AL; Spectrum Bullpen, LLC, Orlando, limiting the recovery of antitrust order shall be evaluated under a FL; The Catholic University of America, plaintiffs to actual damages under preponderance of the evidence Washington, DC; IERUS Technologies, specified circumstances. Pursuant to Section 6(b) of the Act, standard. Inc., Huntsville, AL; Expedition Technology, Inc., Dulles, VA; Stryke the identities of the parties to the XV. Expiration of Final Judgment Industries, LLC, Fort Wayne, IN; Domo venture are: General Motors Holdings Unless this Court grants an extension, Tactical Communications, Pinellas Park, LLC, Warren, MI; Ford Motor Company, this Final Judgment shall expire ten (10) FL; and Telspan Data, LLC, Concord, Dearborn, MI; Hyundai-Kia America years from the date of its entry, except CA, have been added as parties to this Technical Center Inc., Superior that after five years from the date of its venture. Township, MI; and Nissan Technical entry, this Final Judgment may be Boeing Company, Arlington, VA; JRC Center North America, Farmington terminated upon notice by the United Integrated Systems, Inc., Washington, Hills, MI. The general area of VSC8 States to the Court and the Parties that DC; Signautics Engineering Services, Consortium’s planned activity is the divestitures have been completed LLC, Dunedin, FL; Colorado School of collaboration to conduct or facilitate and that the continuation of the decree Mines, Golden, CO; Black River Systems cooperative research, development, no longer is necessary or in the public Company, Inc., Utica, NY; Darkblade testing, and evaluation procedures to interest. Systems Corporation, Stafford, VA; and ANRA Technologies, LLC, Stone Ridge, gain further knowledge and XVI. Public Interest Determination VA, have withdrawn from this venture. understanding of connected vehicle Entry of this Final Judgment is in the No other changes have been made in interactions and/or applications for public interest. The parties have either the membership or planned vehicles that are intended to transform complied with the requirements of the activity of the group research project. surface transportation safety, mobility, Antitrust Procedures and Penalties Act, Membership in this group research and environmental performance through 15 U.S.C § 16, including making copies project remains open, and NSC intends a connected vehicle environment. VSC8 available to the public of this Final to file additional written notifications Consortium’s objectives are to promote Judgment, the Competitive Impact disclosing all changes in membership. the interests of the automotive sector Statement, and any comments thereon, On Septmember 24, 2014, NSC filed while maintaining impartiality, the and the United States’ response to its original notification pursuant to independence of its members, and comments. Based upon the record Section 6(a) of the Act. The Department vendor neutrality. before the Court, which includes the of Justice published a notice in the Patricia A. Brink, Federal Register pursuant to Section Competitive Impact Statement and any Director of Civil Enforcement, Antitrust comments and responses to comments 6(b) of the Act on November 4, 2014 (79 Division. FR 65424). filed with the Court, entry of this Final [FR Doc. 2017–24549 Filed 11–9–17; 8:45 am] Judgment is in the public interest. The last notification was filed with the Department on July 12, 2017. A BILLING CODE P llllllllllllllllll Date: notice was published in the Federal Court approval subject to procedures of Register pursuant to Section 6(b) of the Antitrust Procedures and Penalties Act, 15 DEPARTMENT OF JUSTICE U.S.C. § 16. Act on August 15, 2017 (82 FR 38710). lllllllllllllllllllll Patricia A. Brink, Antitrust Division United States District Judge Director of Civil Enforcement, Antitrust Notice Pursuant to the National Division. [FR Doc. 2017–24548 Filed 11–9–17; 8:45 am] Cooperative Research and Production BILLING CODE 4410–11–P [FR Doc. 2017–24547 Filed 11–9–17; 8:45 am] Act of 1993—PDES, Inc. BILLING CODE P Notice is hereby given that, on DEPARTMENT OF JUSTICE October 10, 2017, pursuant to Section DEPARTMENT OF JUSTICE 6(a) of the National Cooperative Antitrust Division Research and Production Act of 1993, Antitrust Division Notice Pursuant to the National 15 U.S.C. 4301 et seq. (‘‘the Act’’), Cooperative Research and Production Notice Pursuant to the National PDES, Inc. (‘‘PDES’’), filed written Act of 1993—National Spectrum Cooperative Research and Production notifications simultaneously with the Consortium Act of 1993—Vehicle Safety Attorney General and the Federal Trade Communications 8 Consortium Commission disclosing changes in its Notice is hereby given that, on membership. The notifications were October 13, 2017, pursuant to Section Notice is hereby given that, on filed for the purpose of extending the 6(a) of the National Cooperative October 13, 2017, pursuant to Section Act’s provisions limiting the recovery of Research and Production Act of 1993, 6(a) of the National Cooperative antitrust plaintiffs to actual damages 15 U.S.C. 4301 et seq. (‘‘the Act’’), Research and Production Act of 1993, under specified circumstances. National Spectrum Consortium (‘‘NSC’’) 15 U.S.C. 4301 et seq. (‘‘the Act’’), Specifically, Capvidia, Leuven, has filed written notifications Vehicle Safety Communications 8 BELGIUM; Engesis, Rome, ITALY;
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Honeywell, Phoenix, AZ; LKSoftWare notifications disclosing all changes in electronically at http://www.justice.gov/ GmbH, Kuenzell, GERMANY; and membership. enrd/consent-decrees. NARA, Rocket Center, WV, have On June 17, 2015, UHD Alliance filed Cherie L. Rogers, withdrawn as parties to this venture. its original notification pursuant to Assistant Section Chief, Environmental No other changes have been made in Section 6(a) of the Act. The Department either the membership or planned Defense Section, Environment and Natural of Justice published a notice in the Resources Division. activity of the group research project. Federal Register pursuant to Section Membership in this group research [FR Doc. 2017–24461 Filed 11–9–17; 8:45 am] 6(b) of the Act on July 17, 2015 (80 FR BILLING CODE 4410–15–P project remains open, and PDES intends 42537). to file additional written notifications The last notification was filed with disclosing all changes in membership. On September 20, 1988, PDES filed its the Department on June 6, 2017. A DEPARTMENT OF LABOR original notification pursuant to Section notice was published in the Federal 6(a) of the Act. The Department of Register pursuant to Section 6(b) of the Employment and Training Justice published a notice in the Federal Act on July 5, 2017 (82 FR 31069). Administration Register pursuant to Section 6(b) of the Patricia A. Brink, Agency Information Collection Act on October 14, 1988 (53 FR 40282). Director of Civil Enforcement, Antitrust Activities; Comment Request; The last notification was filed with Division. Contribution Operations, ETA–581 the Department on April 20, 2016. A [FR Doc. 2017–24550 Filed 11–9–17; 8:45 am] notice was published in the Federal BILLING CODE P AGENCY: Employment and Training Register pursuant to Section 6(b) of the Administration, Department of Labor. Act on May 24, 2016 (81 FR 32776). ACTION: Notice. DEPARTMENT OF JUSTICE Patricia A. Brink, SUMMARY: The Department of Labor Director of Civil Enforcement, Antitrust Notice of Lodging Proposed Consent (DOL), Employment and Training Division. Decree Administration (ETA) is soliciting [FR Doc. 2017–24546 Filed 11–9–17; 8:45 am] comments concerning a proposed BILLING CODE P In accordance with Departmental extension for the authority to conduct Policy, 28 CFR 50.7, notice is hereby the information collection request (ICR) given that a proposed Consent Decree in titled, ‘‘Contribution Operations, ETA– DEPARTMENT OF JUSTICE United States v. Black Tea Oil, LLC, et 581.’’ This comment request is part of Antitrust Division al., Case No. 2:17–cv–02030, was lodged continuing Departmental efforts to with the United States District Court for reduce paperwork and respondent Notice Pursuant to the National the District of Kansas on November 6, burden in accordance with the Cooperative Research and Production 2017. Paperwork Reduction Act of 1995 Act of 1993—UHD Alliance, Inc. This proposed Consent Decree (PRA). concerns a complaint filed by the DATES: Consideration will be given to all Notice is hereby given that, on United States against Black Tea Oil, LLC written comments received by January September 28, 2017, pursuant to Section and Christopher C. Leiker, pursuant to 12, 2018. 6(a) of the National Cooperative 33 U.S.C. 1319(b) and (d), to obtain ADDRESSES: A copy of this ICR with Research and Production Act of 1993, injunctive relief from and impose civil 15 U.S.C. 4301 et seq. (‘‘the Act’’), UHD applicable supporting documentation; penalties against the Defendants for including a description of the likely Alliance, Inc. (‘‘UHD Alliance’’) filed violating the Clean Water Act by written notifications simultaneously respondents, proposed frequency of discharging pollutants without a permit responses, and estimated total burden with the Attorney General and the into waters of the United States. The Federal Trade Commission disclosing may be obtained free by contacting proposed Consent Decree resolves these Patrick Holmes by telephone at (202) changes in its membership. The allegations by requiring the Defendants notifications were filed for the purpose 693–3203 (this is not a toll-free number) to restore the impacted areas and to pay or by email at Holmes.Patrick.G@ of extending the Act’s provisions a civil penalty. limiting the recovery of antitrust dol.gov. plaintiffs to actual damages under The Department of Justice will accept Submit written comments about, or specified circumstances. Specifically, written comments relating to this requests for a copy of, this ICR by mail ASUSTeK Computer Inc., Taipei, proposed Consent Decree for thirty (30) or courier to the U.S. Department of TAIWAN, and THX Ltd., San Francisco, days from the date of publication of this Labor, Employment and Training CA, have been added as parties to this Notice. Please address comments to Administration, Office of venture. Phillip R. Dupre´, Trial Attorney, United Unemployment Insurance, 200 Also, European Broadcasting Union States Department of Justice, Constitution Ave. NW., Room S–4520, (EBU), Geneva, SWITZERLAND; Environment and Natural Resources Washington, DC 20210; by email: Eutelsat SA, Paris, FRANCE; Ittiam Division, Environmental Defense [email protected]. Systems Inc., Plano, TX; Orange Labs, Section, Post Office Box 7611, FOR FURTHER INFORMATION CONTACT: Sevigne, FRANCE; and Sharp Washington, DC 20044, and refer to Patrick Holmes by telephone at (202) Corporation, Tochigi, JAPAN, have been United States v. Black Tea Oil, LLC, et 693–3203 (this is not a toll-free number) dropped as parties to this venture. al., DJ #90–5–1–1–20653. or by email [email protected]. No other changes have been made in The proposed Consent Decree may be SUPPLEMENTARY INFORMATION: The DOL, either the membership or planned examined at the Clerk’s Office, United as part of continuing efforts to reduce activity of the group research project. States District Court for the District of paperwork and respondent burden, Membership in this group research Kansas, 500 State Avenue, Kansas City, conducts a pre-clearance consultation project remains open, and UHD Alliance KS 66101. In addition, the proposed program to provide the general public intends to file additional written Consent Decree may be examined and Federal agencies an opportunity to
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comment on proposed and/or • Evaluate whether the proposed Please contact Rachel Evans at continuing collections of information collection of information is necessary [email protected] to obtain a visitor before submitting them to the OMB for for the proper performance of the badge. All visitors to the NSF will be final approval. This program helps to functions of the agency, including required to show photo ID to obtain a ensure requested data can be provided whether the information will have badge. in the desired format, reporting burden practical utility; Type of Meeting: Open. (time and financial resources) is • Evaluate the accuracy of the minimized, collection instruments are agency’s estimate of the burden of the Contact Person: Brent Miller, National clearly understood, and the impact of proposed collection of information, Science Foundation, 2415 Eisenhower collection requirements can be properly including the validity of the Avenue, Room C 12016, Alexandria, VA assessed. methodology and assumptions used; 22314; Tel No.: (703) 292–8400. • State UI agencies report data on the Enhance the quality, utility, and Purpose of Meeting: The Advisory ETA 581 report in order to measure clarity of the information to be Committee for the Directorate for performance, accuracy and promptness collected; and • Biological Sciences (BIO) provides in employer registrations, timeliness of Minimize the burden of the advice, recommendations, and oversight filing contribution and wage reports by collection of information on those who concerning major program emphases, employers, collections (accounts are to respond, including through the directions, and goals for the research- receivable), and field audits of use of appropriate automated, related activities of the divisions that employers. Data on the report also electronic, mechanical, or other make up BIO. measures state efforts to detect employer technological collection techniques or tax avoidance schemes, which is known other forms of information technology, Agenda: This meeting will be held as State Unemployment Tax Act (SUTA) e.g., permitting electronic submission of telephonically among the Advisory Dumping. Section 303(k) of the Social responses. Committee members; public visitors Security Act requires states to detect Agency: DOL–ETA. will be able to attend the meeting in SUTA Dumping. ETA uses the Type of Review: Extension without person at NSF headquarters. Agenda information reported on the report to changes. items will include welcoming new monitor and measure program Title of Collection: Contribution Advisory Committee (AC) members, performance and make projections and Operations, ETA–581. review of the AC’s function, discussion forecasts in conjunction with the Form: ETA 581, Contribution of potential future AC activities, and budgetary process. Sections 303(a)(6) Operations. other matters relevant to the Directorate and (k) of the Social Security Act OMB Control Number: 1205–0178. for Biological Sciences. authorizes this information collection. Affected Public: State governments. This information collection is subject Estimated Number of Respondents: Dated: November 6, 2017. to the PRA. A Federal agency generally 53. Crystal Robinson, cannot conduct or sponsor a collection Frequency: Quarterly. Committee Management Officer. of information, and the public is Total Estimated Annual Responses: 212. [FR Doc. 2017–24543 Filed 11–9–17; 8:45 am] generally not required to respond to an BILLING CODE 7555–01–P information collection, unless it is Estimated Average Time per approved by the OMB under the PRA Response: 7.5 hours. Estimated Total Annual Burden and displays a currently valid OMB NATIONAL SCIENCE FOUNDATION Control Number. In addition, Hours: 1,590 hours. Total Estimated Annual Other Cost notwithstanding any other provisions of Burden: $0. Notice of Permits Issued Under the law, no person shall generally be subject Antarctic Conservation Act of 1978 to penalty for failing to comply with a Authority: 44 U.S.C. 3506(c)(2)(A). collection of information that does not Nancy M. Rooney, AGENCY: National Science Foundation. display a valid Control Number. See 5 Deputy Assistant Secretary, Employment and ACTION: Notice of permits issued. CFR 1320.5(a) and 1320.6. Training Administration. Interested parties are encouraged to [FR Doc. 2017–24512 Filed 11–9–17; 8:45 am] provide comments to the contact shown SUMMARY: The National Science in the ADDRESSES section. Comments BILLING CODE 4510–FW–P Foundation (NSF) is required to publish must be written to receive notice of permits issued Under the consideration, and they will be Antarctic Conservation Act of 1978. summarized and included in the request NATIONAL SCIENCE FOUNDATION This is the required notice. for OMB approval of the final ICR. In Advisory Committee for Biological FOR FURTHER INFORMATION CONTACT: order to help ensure appropriate Sciences; Notice of Meeting Nature McGinn, ACA Permit Officer, consideration, comments should Office of Polar Programs, National mention OMB Control Number 1205– In accordance with the Federal Science Foundation, 2415 Eisenhower 0178. Advisory Committee Act (Pub. L. 92– Avenue, Alexandria, VA 22314; 703– Submitted comments will also be a 463, as amended), the National Science matter of public record for this ICR and Foundation (NSF) announces the 292–8224; email: [email protected]. posted on the Internet, without following meeting: SUPPLEMENTARY INFORMATION: On redaction. The DOL encourages Name and Committee Code: Advisory September 14, 2017, the National commenters not to include personally Committee for Biological Sciences Science Foundation published a notice identifiable information, confidential (#1110). in the Federal Register of a permit business data, or other sensitive Date and Time: December 19, 2017; application received. The permit was statements/information in any 1:00 p.m.–3:00 p.m. issued on October 16, 2017 to: comments. Place: National Science Foundation, The DOL is particularly interested in 2415 Eisenhower Avenue, Room E 3410, 1. Jay J. Rotella, Permit No. 2018–012 comments that: Alexandria, VA 22314. 2. Linnea Pearson, Permit No. 2018–013
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3. David J. Smith, Permit No. 2018–010 (ADAMS): You may obtain publicly- agency may not conduct or sponsor, and available documents online in the that a person is not required to respond Nadene G. Kennedy, ADAMS Public Documents collection at to, a collection of information unless it Polar Coordination Specialist, Office of Polar http://www.nrc.gov/reading-rm/ displays a currently valid OMB control Programs. adams.html. To begin the search, select number. [FR Doc. 2017–24173 Filed 11–9–17; 8:45 am] ‘‘ADAMS Public Documents’’ and then The NRC published a Federal BILLING CODE 7555–01–P select ‘‘Begin Web-based ADAMS Register notice with a 60-day comment Search.’’ For problems with ADAMS, period on this information collection on please contact the NRC’s Public April 6, 2017 (82 FR 16862). NUCLEAR REGULATORY Document Room (PDR) reference staff at 1. The title of the information COMMISSION 1–800–397–4209, 301–415–4737, or by collection: 10 CFR part 75, ‘‘Information email to [email protected]. The Collection: Safeguards on Nuclear [NRC–2016–0249] supporting statement is available in Material—Implementation of United Information Collection: Safeguards on ADAMS under Accession No. States/International Atomic Energy Nuclear Material—Implementation of ML17173A062. Agency Agreement.’’ • 2. OMB approval number: 3150–0055. United States/International Atomic NRC’s PDR: You may examine and purchase copies of public documents at 3. Type of submission: Extension. Energy Agency Agreement the NRC’s PDR, Room O1–F21, One 4. The form number if applicable: Not AGENCY: Nuclear Regulatory White Flint North, 11555 Rockville applicable. Commission. Pike, Rockville, Maryland 20852. 5. How often the collection is required • or requested: Selected licensees are ACTION: Notice of submission to the NRC’s Clearance Officer: A copy of required to provide reports of nuclear Office of Management and Budget; the collection of information and related material inventory and flow for selected request for comment. instructions may be obtained without charge by contacting the NRC’s facilities under the US/IAEA Safeguards SUMMARY: The U.S. Nuclear Regulatory Clearance Officer, David Cullison, Agreement, permit inspections by Commission (NRC) recently submitted a Office of the Chief Information Officer, International Atomic Energy Agency renewal of an existing collection of U.S. Nuclear Regulatory Commission, Agreement (IAEA) inspectors, information to the Office of Washington, DC 20555–0001; telephone: complementary access of IAEA Management and Budget (OMB) for 301–415–2084; email: inspectors under the Additional review. The information collection is [email protected]. Protocol, give immediate notice to the NRC in specified situations involving entitled, Information Collection: B. Submitting Comments Safeguards on Nuclear Material— the possibility of loss of nuclear Implementation of United States/ The NRC cautions you not to include material, and give notice for imports International Atomic Energy Agency identifying or contact information in and exports of specified amounts of Agreement.’’ comment submissions that you do not nuclear material. Reporting is done want to be publicly disclosed in your when specified events occur. DATES: Submit comments by December comment submission. All comment Recordkeeping for nuclear material 13, 2017. submissions are posted at http:// accounting and control information is ADDRESSES: Submit comments directly www.regulations.gov and entered into done in accordance with specific to the OMB reviewer at: Brandon ADAMS. Comment submissions are not instructions. DeBruhl, Desk Officer, Office of routinely edited to remove identifying 6. Who will be required or asked to Information and Regulatory Affairs or contact information. respond: Licensees of facilities on the (3150–0055), NEOB–10202, Office of If you are requesting or aggregating US eligible list who have been selected Management and Budget, Washington, comments from other persons for by the IAEA for reporting or DC 20503; telephone: 202–395–0710, submission to the OMB, then you recordkeeping activities. email: [email protected]. should inform those persons not to 7. The estimated number of annual FOR FURTHER INFORMATION CONTACT: include identifying or contact responses: 32 (2 reporting responses + David Cullison, NRC Clearance Officer, information that they do not want to be 30 recordkeepers). U.S. Nuclear Regulatory Commission, publicly disclosed in their comment 8. The estimated number of annual Washington, DC 20555–0001; telephone: submission. Your request should state respondents: 30. 301–415–2084; email: that the NRC does not routinely edit 9. An estimate of the total number of [email protected]. comment submissions to remove such hours needed annually to comply with the information collection requirement SUPPLEMENTARY INFORMATION: information before making the comment submissions available to the public or or request: 4,227.1 hours (0.4 reporting I. Obtaining Information and entering the comment submissions into hours + 4226.7 hours recordkeeping). Submitting Comments ADAMS. 10. Abstract: Part 75 of title 10 of the Code of Federal Regulations (10 CFR), A. Obtaining Information II. Background requires selected licensees to provide Please refer to Docket ID NRC–2016– Under the provisions of the reports of nuclear material inventory 0249 when contacting the NRC about Paperwork Reduction Act of 1995 (44 and flow for selected facilities under the the availability of information for this U.S.C. Chapter 35), the NRC recently US/IAEA Safeguards Agreement, permit action. You may obtain publicly- submitted a request for revision of an inspections by IAEA inspectors, available information related to this existing collection of information to complementary access of IAEA action by any of the following methods: OMB for review entitled, ‘‘Information inspectors under the Additional • Federal Rulemaking Web site: Go to Collection: Safeguards on Nuclear Protocol, give immediate notice to the http://www.regulations.gov and search Material—Implementation of United NRC in specified situations involving for Docket ID NRC–2016–0249. States/International Atomic Energy the possibility of loss of nuclear • NRC’s Agencywide Documents Agency Agreement.’’ The NRC hereby material, and give notice for imports Access and Management System informs potential respondents that an and exports of specified amounts of
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nuclear material. This collection is Federal Official (DFO), Christopher NUCLEAR REGULATORY being updated to include approximately Brown (Telephone 301–415–7111 or COMMISSION 25 entities subject to the U.S.-IAEA Email: [email protected]) five [NRC–2016–0174] Caribbean Territories Safeguards days prior to the meeting, if possible, so Agreement (INFCIRC/366). These that appropriate arrangements can be Information Collection: DOE/NRC Form licensees will also follow written made. Thirty-five hard copies of each 740M, Concise Note; DOE/NRC Form material accounting and control presentation or handout should be 741, Nuclear Material Transaction procedures, although actual reporting of provided to the DFO thirty minutes Report; DOE/NRC Form 742, Material transfer and material balance records to before the meeting. In addition, one Balance Report; and DOE/NRC Form the IAEA will be done through the U.S. electronic copy of each presentation 742C, Physical Inventory Listing State system (Nuclear Materials should be emailed to the DFO one day Management and Safeguards System, before the meeting. If an electronic copy AGENCY: Nuclear Regulatory collected under OMB clearance cannot be provided within this Commission. numbers 3150–0003, 3150–0004, 3150– timeframe, presenters should provide ACTION: Notice of submission to the 0057, and 3150–0058.) The NRC needs the DFO with a CD containing each Office of Management and Budget; this information to implement its request for comment. international obligations under the U.S.- presentation at least thirty minutes IAEA Caribbean Territories Safeguards before the meeting. Electronic SUMMARY: The U.S. Nuclear Regulatory Agreement (INFCIRC/366). recordings will be permitted only Commission (NRC) has recently during those portions of the meeting Dated at Rockville, Maryland, this 6th of submitted a renewal of an existing November, 2017. that are open to the public. Detailed collection of information to the Office of For the Nuclear Regulatory Commission. procedures for the conduct of and Management and Budget (OMB) for participation in ACRS meetings were David Cullison, review. The information collections are published in the Federal Register on Clearance Officer, Office of the Chief entitled, ‘‘DOE/NRC Form 740M, Information Officer. October 4, 2017 (82 FR 46312). Concise Note; DOE/NRC Form 741, [FR Doc. 2017–24481 Filed 11–9–17; 8:45 am] Detailed meeting agendas and meeting Nuclear Material Transaction Report; DOE/NRC Form 742, Material Balance BILLING CODE 7590–01–P transcripts are available on the NRC Web site at http://www.nrc.gov/reading- Report; and DOE/NRC Form 742C, rm/doc-collections/acrs. Information Physical Inventory Listing.’’ NUCLEAR REGULATORY regarding topics to be discussed, DATES: Submit comments by December COMMISSION changes to the agenda, whether the 13, 2017. meeting has been canceled or ADDRESSES: Submit comments directly Advisory Committee on Reactor rescheduled, and the time allotted to to the OMB reviewer at: Brandon Safeguards (ACRS); Meeting of the present oral statements can be obtained DeBruhl, Desk Officer, Office of ACRS Subcommittee on APR1400; Information and Regulatory Affairs Notice of Meeting from the Web site cited above or by contacting the identified DFO. (3150–0003, 3150–0004, 3150–0057, The ACRS Subcommittee on APR1400 Moreover, in view of the possibility that and 3150–0058), NEOB–10202, Office of will hold a meeting on November 14, the schedule for ACRS meetings may be Management and Budget, Washington, 2017, at 11545 Rockville Pike, Room T– DC 20503; telephone: 202–395–0710, adjusted by the Chairman as necessary _ 2B1, Rockville, Maryland 20852. to facilitate the conduct of the meeting, email: oira [email protected]. The meeting will be open to public persons planning to attend should check FOR FURTHER INFORMATION CONTACT: attendance with the exception of with these references if such David Cullison, NRC Clearance Officer, portions that may be closed to protect rescheduling would result in a major U.S. Nuclear Regulatory Commission, information that is proprietary pursuant inconvenience. Washington, DC 20555–0001; telephone: to 5 U.S.C. 552b(c)(4). The agenda for 301–415–2084; email: the subject meeting shall be as follows: If attending this meeting, please enter [email protected]. through the One White Flint North SUPPLEMENTARY INFORMATION: Tuesday, November 14, 2017, 8:30 a.m. building, 11555 Rockville Pike, Until 5:00 p.m. Rockville, Maryland 20852. After I. Obtaining Information and The Subcommittee will review registering with Security, please contact Submitting Comments APR1400 design control document Mr. Theron Brown (Telephone 301– A. Obtaining Information Chapter 2, ‘‘Site Characteristics,’’ 415–6207) to be escorted to the meeting Chapter 5, ‘‘Reactor Coolant System and room. Please refer to Docket ID NRC–2016– Connecting Systems,’’ Chapter 11, 0174 when contacting the NRC about ‘‘Radioactive Waste Management,’’ and Dated: November 6, 2017. the availability of information for this Chapter 12, ‘‘Radiation Protection.’’ The Mark L. Banks, action. You may obtain publicly- Subcommittee will hear presentations Chief, Technical Support Branch, Advisory available information related to this by and hold discussions with the NRC Committee on Reactor Safeguards. action by any of the following methods: staff and other interested persons [FR Doc. 2017–24434 Filed 11–8–17; 8:45 am] • Federal Rulemaking Web site: Go to regarding this matter. The BILLING CODE 7590–01–P http://www.regulations.gov and search Subcommittee will gather information, for Docket ID NRC–2016–0174. A copy analyze relevant issues and facts, and of the collection of information and formulate proposed positions and related instructions may be obtained actions, as appropriate, for deliberation without charge by accessing Docket ID by the Full Committee. NRC–2016–0174. Members of the public desiring to • NRC’s Agencywide Documents provide oral statements and/or written Access and Management System comments should notify the Designated (ADAMS): You may obtain publicly-
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available documents online in the publicly disclosed in their comment submit a DOE/NRC Form 741 to ADAMS Public Documents collection at submission. Your request should state document the change. Additional http://www.nrc.gov/reading-rm/ that the NRC does not routinely edit information regarding these transactions adams.html. To begin the search, select comment submissions to remove such shall be submitted through Form 740M, ‘‘ADAMS Public Documents’’ and then information before making the comment with Safeguards Information identified select ‘‘Begin Web-based ADAMS submissions available to the public or and handled in accordance with section Search.’’ For problems with ADAMS, entering the comment submissions into 73.21 of title 10 of the Code of Federal please contact the NRC’s Public ADAMS. Regulations (10 CFR), ‘‘Requirements for Document Room (PDR) reference staff at the Protection of Safeguards II. Background 1–800–397–4209, 301–415–4737, or by Information.’’ email to [email protected]. A copy Under the provisions of the Any licensee who had possessed in of the collection of information and Paperwork Reduction Act of 1995 (44 the previous reporting period, at any related instructions may be obtained U.S.C. Chapter 35), the NRC recently one time and location, nuclear material without charge by accessing the submitted a revision of a collection of in a quantity totaling one gram or more following ADAMS Accession No. information to OMB for review entitled, shall complete DOE/NRC Form 742. In ML16252A183. Guidance documents ‘‘DOE/NRC Form 740M, Concise Note; addition, each licensee, Federal or State, are available for the Forms as follows: DOE/NRC Form 741, Nuclear Material who is authorized to possess, at any one NUREG/BR–0006, Revision 7 (ADAMS Transaction Report; DOE/NRC Form time or location, one kilogram of foreign Accession No. ML111740924), and 742, Material Balance Report; and DOE/ obligated source material, is required to NUREG/BR–0007 (ADAMS Accession NRC Form 742C, Physical Inventory file with the NRC an annual statement No. ML090120288). The supporting Listing.’’ The NRC hereby informs of source material inventory which is statements for each DOE/NRC Form and potential respondents that an agency foreign obligated. the Forms themselves are available as may not conduct or sponsor, and that a Any licensee, who had possessed in follows: DOE/NRC Form 740M, person is not required to respond to, a the previous reporting period, at any ‘‘Concise Note’’ (ADAMS Accession collection of information unless it one time and location, special nuclear Nos. ML17009A233 and displays a currently valid OMB control material in a quantity totaling one gram ML16252A189); DOE/NRC Form 741, number. or more shall complete DOE/NRC Form ‘‘Nuclear Material Transaction Report’’ The NRC published a Federal 742C. (ADAMS Accession Nos. ML17009A234 Register notice with a 60-day comment 7. The estimated number of annual and ML16252A191); DOE/NRC Form period on this information collection on responses: 742, ‘‘Material Balance Report’’ October 28, 2016, (81 FR 75167). DOE/NRC Form 740M: 175. (ADAMS Accession Nos. ML17009A235 1. The title of the information DOE/NRC Form 741: 10,000. and ML16252A192); and DOE/NRC collection: DOE/NRC Form 740M, DOE/NRC Form 742: 385. Form 742C, ‘‘Physical Inventory Concise Note; DOE/NRC Form 741, DOE/NRC Form 742C: 385. Listing’’ (ADAMS Accession Nos. Nuclear Material Transaction Report; 8. The estimated number of annual ML17009A236 and ML16252A193). DOE/NRC Form 742, Material Balance respondents: • NRC’s PDR: You may examine and Report; and DOE/NRC Form 742C, DOE/NRC Form 740M: 40. purchase copies of public documents at Physical Inventory Listing. DOE/NRC Form 741: 350. the NRC’s PDR, Room O1–F21, One 2. OMB approval numbers: DOE/NRC Form 742: 385. White Flint North, 11555 Rockville DOE/NRC Form 740M: 3150–0057. DOE/NRC Form 742C: 385. Pike, Rockville, Maryland 20852. DOE/NRC Form 741: 3150–0003. 9. An estimate of the total number of • NRC’s Clearance Officer: A copy of DOE/NRC Form 742: 3150–0004. hours needed annually to comply with the collection of information and related DOE/NRC Form 742C: 3150–0058. the information collection requirement instructions may be obtained without 3. Type of submission: Revision. or request: charge by contacting the NRC’s 4. The form number if applicable: DOE/NRC Form 740M: 131. Clearance Officer, David Cullison, DOE/NRC Forms 740M, 741, 742, and DOE/NRC Form 741: 12,500. Office of the Chief Information Officer, 742C. DOE/NRC Form 742: 1,310. U.S. Nuclear Regulatory Commission, 5. How often the collection is required DOE/NRC Form 742C: 1,490. Washington, DC 20555–0001; telephone: or requested: DOE/NRC Form 741, 10. Abstract: Persons licensed to 301–415–2084; email: Nuclear Material Transaction Reports possess specified quantities of nuclear [email protected]. will be collected whenever nuclear material currently report inventory and material is shipped or received into the transaction of material to the Nuclear B. Submitting Comments Material Balance Area; DOE/NRC Form Materials Management and Safeguards The NRC cautions you not to include 742, Material Balance Report will be System via the DOE/NRC Forms: DOE/ identifying or contact information in collected on an annual basis; DOE/NRC NRC Form 740M, Concise Note; DOE/ comment submissions that you do not Form 742C, Physical Inventory Listing NRC Form 741, Nuclear Material want to be publicly disclosed in your will be collected on an annual basis; Transaction Report; DOE/NRC Form comment submission. All comment DOE/NRC Form 740M, Concise Note 742, Material Balance Report; and DOE/ submissions are posted at http:// Forms are used when needed. NRC Form 742C, Physical Inventory www.regulations.gov and entered into 6. Who will be required or asked to Listing. This collection is being revised ADAMS. Comment submissions are not respond: Persons licensed to possess to include approximately 25 entities routinely edited to remove identifying specified quantities of nuclear material subject to the U.S.-IAEA Caribbean or contact information. and entities subject to the U.S.-IAEA Territories Safeguards Agreement If you are requesting or aggregating Caribbean Territories Safeguards (INFCIRC/366). Part 75 requires comments from other persons for Agreement (INFCIRC/366) are required licensees to provide reports of nuclear submission to the OMB, then you to respond as follows: material inventory and flow for entities should inform those persons not to Any licensee who ships, receives, or under the U.S.-IAEA Caribbean include identifying or contact otherwise undergoes an inventory Territories Safeguards Agreement information that they do not want to be change of nuclear material is required to (INFCIRC/366), permit inspections by
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IAEA inspectors, give immediate notice questions about NRC dockets to Carol In addition, more recent regulatory to the NRC in specified situations Gallagher; telephone: 301–415–3463; guidance has been issued that involving the possibility of loss of email: [email protected]. For supersedes the guidance in RG 5.65. nuclear material, and give notice for technical questions, contact the • The RG 5.66, ‘‘Access Authorization imports and exports of specified individuals listed in the FOR FURTHER Program for Nuclear Power Plants,’’ Rev. amounts of nuclear material. These INFORMATION CONTACT section of this 2 (October 2011) supersedes RG 5.65. licensees will also follow written document. The RG 5.65 does not address the material accounting and control • NRC’s Agencywide Documents current requirements of 10 CFR 73.56 procedures. Reporting of transfer and Access and Management System with regard to access authorization at material balance records to the IAEA (ADAMS): You may obtain publicly- nuclear power plants. Instead, RG 5.66 will be done through the U.S. State available documents online in the provides an acceptable approach by system (Nuclear Materials Management ADAMS Public Documents collection at which licensees can establish and and Safeguards System, collected under http://www.nrc.gov/reading-rm/ implement an access authorization OMB clearance numbers 3150–0003, adams.html. To begin the search, select program for granting unescorted access 3150–0004, 3150–0057, and 3150– ‘‘ADAMS Public Documents’’ and then to protected and vital areas of a nuclear 0058.) The NRC needs this information select ‘‘Begin Web-based ADAMS power plant. • The RG 5.76, ‘‘Physical Protection to implement its international Search.’’ For problems with ADAMS, at Nuclear Power Reactors’’ (July 2009), obligations under the U.S.-IAEA please contact the NRC’s Public which was issued to facilitate Caribbean Territories Safeguards Document Room (PDR) reference staff at implementation of the new 10 CFR part Agreement (INFCIRC/366). 1–800–397–4209, 301–415–4737, or by 73 rule in 2009, supersedes RG 5.65. email to [email protected]. The Dated at Rockville, Maryland, this 6th day Specifically, RG 5.65 contains of November, 2017. ADAMS accession number for each duplicative or outdated discussions document referenced (if it available in For the Nuclear Regulatory Commission. regarding protection of security ADAMS) is provided the first time that David Cullison, equipment, vital and protected area NRC Clearance Officer, Office of the Chief a document is referenced. The basis for transients, delays, barriers, underground Information Officer. withdrawal of RG 5.65 is available in pathways, power, escort, ingress and [FR Doc. 2017–24480 Filed 11–9–17; 8:45 am] ADAMS under Accession No. egress, record keeping, and review/audit ML17262A504. BILLING CODE 7590–01–P requirements. • NRC’s PDR: You may examine and • The RG 5.12, ‘‘General Use of Locks purchase copies of public documents at in the Protection and Control of: NUCLEAR REGULATORY the NRC’s PDR, Room O1–F21, One Facilities, Radioactive Materials, COMMISSION White Flint North, 11555 Rockville Classified Information, Classified [NRC–2017–0216] Pike, Rockville, Maryland 20852. Matter, and Safeguards Information,’’ FOR FURTHER INFORMATION CONTACT: Rev. 1 (October 2016), supersedes RG Vital Area Access Controls, Protection Angela Wu, Office of Nuclear Reactor 5.65. Regarding keys and locks, the of Physical Security Equipment, and Regulation, telephone: 301–287–3645, guidance offered in RG 5.65 is brief and Key and Lock Controls email: [email protected], or Mekonen limited to two paragraphs, discussing Bayssie, Office of Nuclear Regulatory the requirement and frequency to AGENCY: Nuclear Regulatory change and rotate keys, locks, and Commission. Research, telephone: 301–415–1699, email: [email protected]. Both combinations. The same information is ACTION: Regulatory guide; withdrawal. are staff members of the U.S. Nuclear discussed in much greater detail in RG Regulatory Commission, Washington, 5.12. SUMMARY: The U.S. Nuclear Regulatory • Commission (NRC) is withdrawing DC 20555–0001. The RG 5.74, ‘‘Managing the Safety/ Regulatory Guide (RG) 5.65, ‘‘Vital Area Security Interface,’’ Rev. 1 (April 2015), SUPPLEMENTARY INFORMATION: The NRC supersedes RG 5.65. With regard to Access Controls, Protection of Physical is withdrawing RG 5.65, ‘‘Vital Area Security Equipment, and Key and Lock managing the safety and security Access Controls, Protection of Physical interface, RG 5.65 provides only brief Controls,’’ dated September 1986. This Security Equipment, and Key and Lock document is being withdrawn because it guidance (one paragraph) on the cross Controls,’’ because of the following training of roles, responsibilities, and is outdated and has been superseded by regulatory and technical issues: other NRC guidance, and therefore, no general practices of the safety and • On March 27, 2009 (74 FR 13926), security organizations as a mechanism longer provides methods that the NRC the Commission amended part 73 of staff finds acceptable in future requests to reduce interface problems. The RG title 10 of the Code of Federal 5.74 provides more detailed guidance or applications for NRC’s licensing Regulations (10 CFR), for nuclear power actions. for training to aid the interface between plants to incorporate security safety and security organizations. DATES: The applicable date of the requirements that were issued through withdrawal of RG 5.65 is November 13, Commission security orders as a result II. Further Information 2017. of the September 11, 2001 terrorist The withdrawal of RG 5.65 does not ADDRESSES: Please refer to Docket ID attacks. In addition, the rulemaking alter any prior or existing NRC licensing NRC–2017–0216 when contacting the added several new requirements to approval or the acceptability of licensee NRC about the availability of incorporate insights gained from commitments made regarding the information regarding this document. implementation of the security orders, withdrawn guidance. Although RG 5.65 You may obtain publicly-available review of site security plans, is withdrawn, current licensees information related to this document implementation of the NRC’s enhanced referencing this RG may continue to do using any of the following methods: baseline inspection program, and the so, and withdrawal does not affect any • Federal Rulemaking Web site: Go to NRC’s evaluation of force-on-force existing licenses or agreements. http://www.regulations.gov and search exercises. As a result, the guidance in However, by withdrawing RG 5.65, the for Docket ID NRC–2017–0216. Address RG 5.65 became outdated. NRC no longer approves use of the
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guidance in future requests or Detailed meeting agendas and meeting Investment Company Act,1 any applications for NRC’s licensing actions. transcripts are available on the NRC company defined in section 2(a)(48)(A) Dated at Rockville, Maryland, this 6th day Web site at http://www.nrc.gov/reading- and (B) of the Investment Company Act of November, 2017. rm/doc-collections/acrs. Information may, if it meets certain enumerated For the Nuclear Regulatory Commission. regarding topics to be discussed, eligibility requirements, elect to be Thomas H. Boyce, changes to the agenda, whether the subject to the provisions of Sections 55 meeting has been canceled or through 65 of the Investment Company Chief, Regulatory Guidance and Generic Issues Branch, Division of Engineering, Office rescheduled, and the time allotted to Act by filing with the Commission a of Nuclear Regulatory Research. present oral statements can be obtained notification of election. Under section 54(c) of the Investment Company Act,2 [FR Doc. 2017–24484 Filed 11–9–17; 8:45 am] from the Web site cited above or by contacting the identified DFO. any business development company BILLING CODE 7590–01–P Moreover, in view of the possibility that may voluntarily withdraw its election the schedule for ACRS meetings may be under section 54(a) of the Investment NUCLEAR REGULATORY adjusted by the Chairman as necessary Company Act by filing a notice of COMMISSION to facilitate the conduct of the meeting, withdrawal of election with the persons planning to attend should check Commission. The Commission has Advisory Committee on Reactor with these references if such adopted Form N–54C as the form for the Safeguards (ACRS); Meeting of the rescheduling would result in a major notification of withdrawal of election to ACRS Subcommittee on Regulatory inconvenience. be subject to Sections 55 through 65 of Policies & Practices; Notice of Meeting If attending this meeting, please enter the Investment Company Act. The purpose of Form N–54C is to notify the The ACRS Subcommittee on through the One White Flint North building, 11555 Rockville Pike, Commission that the business Regulatory Policies and Practices will development company withdraws its hold a meeting on November 15, 2017, Rockville, Maryland 20852. After registering with Security, please contact election to be subject to Sections 55 at 11545 Rockville Pike, Room T–2B1, through 65 of the Investment Company Rockville, Maryland 20852. Mr. Theron Brown (Telephone 301– 415–6207) to be escorted to the meeting Act. This meeting will be open to public The Commission estimates that on room. attendance. The agenda for the subject average approximately four business meeting shall be as follows: Dated: October 31, 2017. development companies file Wednesday, November 15, 2017—8:30 Mark L. Banks, notifications on Form N–54C each year. a.m. Until 12:00 p.m. Chief, Technical Support Branch, Advisory Each of those business development Committee on Reactor Safeguards. companies need only make a single The Subcommittee will review the [FR Doc. 2017–24433 Filed 11–9–17; 8:45 am] filing of Form N–54C. The Commission Early Site Permit for Clinch River and BILLING CODE 7590–01–P further estimates that this information will hear presentations by and hold collection imposes a burden of one discussions with the NRC staff and hour, resulting in a total annual burden other interested persons regarding this of four hours. Based on the estimated matter. The Subcommittee will gather SECURITIES AND EXCHANGE wage rate, the total cost to the business information, analyze relevant issues and COMMISSION development company industry of the facts, and formulate proposed positions hour burden for complying with Form and actions, as appropriate, for Submission for OMB Review; N–54C would be approximately $1,380.3 deliberation by the Full Committee. Comment Request The collection of information under Members of the public desiring to Form N–54C is mandatory. The provide oral statements and/or written Upon Written Request, Copies Available information provided by the form is not comments should notify the Designated From: Securities and Exchange kept confidential. An agency may not Federal Official (DFO), Quynh Nguyen Commission, Office of FOIA Services, conduct or sponsor, and a person is not (Telephone 301–415–5844 or Email 100 F Street NE., Washington, DC required to respond to, a collection of [email protected]) five days prior 20549–2736. information unless it displays a to the meeting, if possible, so that Extension: currently valid control number. appropriate arrangements can be made. Form N–54C; SEC File No. 270–184, OMB The public may view the background Thirty-five hard copies of each Control No. 3235–0236 documentation for this information presentation or handout should be collection at the following Web site, provided to the DFO thirty minutes Notice is hereby given that, pursuant www.reginfo.gov. Comments should be before the meeting. In addition, one to the Paperwork Reduction Act of 1995 directed to: (i) Desk Officer for the electronic copy of each presentation (44 U.S.C. 3501 et seq.), the Securities should be emailed to the DFO one day and Exchange Commission (the 1 15 U.S.C. 80a–53(a). before the meeting. If an electronic copy ‘‘Commission’’) has submitted to the 2 15 U.S.C. 80a–53(c). cannot be provided within this Office of Management and Budget a 3 The industry burden is calculated by timeframe, presenters should provide request for extension of the previously multiplying the total annual hour burden to prepare approved collection of information Form N–54C (four) by the estimated hourly wage the DFO with a CD containing each rate of $345 for a compliance attorney or other presentation at least thirty minutes discussed below. business development company employee with before the meeting. Electronic Certain investment companies can similar duties and responsibilities. The estimated elect to be regulated as business wage figure is based on published rates for recordings will be permitted only compliance attorneys from the Securities Industry during those portions of the meeting development companies, as defined in and Financial Markets Association’s Report on that are open to the public. Detailed section 2(a)(48) of the Investment Management & Professional Earnings in the procedures for the conduct of and Company Act of 1940 (‘‘Investment Securities Industry 2013, modified by Commission Company Act’’), under sections 55 staff to account for an 1800 hour work-year and participation in ACRS meetings were inflation, and multiplied by 5.35 to account for published in the Federal Register on through 65 of the Investment Company bonuses, firm size, employee benefits and overhead, October 4, 2017 (82 FR 46312). Act. Under section 54(a) of the yielding an effective hourly rate of $1,380.
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Securities and Exchange Commission, Funds (‘‘Feeder Funds’’) to create and funds (‘‘ETFs’’).1 Fund shares will be Office of Information and Regulatory redeem Creation Units in-kind in a purchased and redeemed at their NAV Affairs, Office of Management and master-feeder structure. in Creation Units only. All orders to Budget, Room 10102, New Executive APPLICANTS: CBOE Vest Financial, LLC purchase Creation Units and all Office Building, Washington, DC 20503, (the ‘‘Initial Adviser’’), a Delaware redemption requests will be placed by or by sending an email to: Shagufta_ limited liability company registered as or through an ‘‘Authorized Participant’’ [email protected]; and (ii) Pamela an investment adviser under the which will have signed a participant Dyson, Director/Chief Information Investment Advisers Act of 1940, ETF agreement with the Distributor. Shares Officer, Securities and Exchange Series Solutions (the ‘‘Trust’’), a will be listed and traded individually on Commission, c/o Remi Pavlik-Simon, Delaware statutory trust registered a national securities exchange, where 100 F Street NE., Washington, DC 20549 under the Act as an open-end share prices will be based on the current or send an email to: PRA_Mailbox@ management investment company with bid/offer market. Certain Funds may sec.gov. Comments must be submitted to multiple series. operate as Feeder Funds in a master- OMB within 30 days of this notice. FILING DATES: The application was filed feeder structure. Any order granting the Dated: November 7, 2017. on July 18, 2017 and amended on requested relief would be subject to the Eduardo A. Aleman, October 19, 2017. terms and conditions stated in the application. Assistant Secretary. HEARING OR NOTIFICATION OF HEARING: An 2. Each Fund will consist of a [FR Doc. 2017–24486 Filed 11–9–17; 8:45 am] order granting the requested relief will be issued unless the Commission orders portfolio of securities and other assets BILLING CODE 8011–01–P a hearing. Interested persons may and investment positions (‘‘Portfolio request a hearing by writing to the Instruments’’). Each Fund will disclose SECURITIES AND EXCHANGE Commission’s Secretary and serving on its Web site the identities and COMMISSION applicants with a copy of the request, quantities of the Portfolio Instruments personally or by mail. Hearing requests that will form the basis for the Fund’s [Investment Company Act Release No. should be received by the Commission calculation of NAV at the end of the 32896; 812–14801] by 5:30 p.m. on December 1, 2017, and day. should be accompanied by proof of CBOE Vest Financial, LLC, et al. 3. Shares will be purchased and service on applicants, in the form of an redeemed in Creation Units only and November 7, 2017. affidavit, or for lawyers, a certificate of generally on an in-kind basis. Except AGENCY: Securities and Exchange service. Pursuant to rule 0–5 under the where the purchase or redemption will Commission (‘‘Commission’’). Act, hearing requests should state the include cash under the limited nature of the writer’s interest, any facts ACTION: Notice. circumstances specified in the bearing upon the desirability of a application, purchasers will be required Notice of an application for an order hearing on the matter, the reason for the to purchase Creation Units by under section 6(c) of the Investment request, and the issues contested. depositing specified instruments Company Act of 1940 (the ‘‘Act’’) for an Persons who wish to be notified of a (‘‘Deposit Instruments’’), and exemption from sections 2(a)(32), hearing may request notification by shareholders redeeming their shares 5(a)(1), 22(d), and 22(e) of the Act and writing to the Commission’s Secretary. will receive specified instruments rule 22c–1 under the Act, under ADDRESSES: Secretary, Securities and (‘‘Redemption Instruments’’). The sections 6(c) and 17(b) of the Act for an Exchange Commission, 100 F Street NE., Deposit Instruments and the exemption from sections 17(a)(1) and Washington, DC 20549–1090; Redemption Instruments will each 17(a)(2) of the Act, and under section Applicants: W. John McGuire, Esq., correspond pro rata to the positions in 12(d)(1)(J) of the Act for an exemption Morgan, Lewis & Bockius LLP, 1111 the Fund’s portfolio (including cash from sections 12(d)(1)(A) and Pennsylvania Avenue NW., Washington, positions) except as specified in the 12(d)(1)(B) of the Act. The requested DC 20004–2541 and Michael D. application. order would permit (a) actively- Barolsky, Esq., U.S. Bancorp Fund 4. Because shares will not be managed series of certain open-end Services, LLC, 615 E. Michigan Street, individually redeemable, applicants management investment companies Milwaukee, WI 53202. request an exemption from section (‘‘Funds’’) to issue shares redeemable in FOR FURTHER INFORMATION CONTACT: Brad 5(a)(1) and section 2(a)(32) of the Act large aggregations only (‘‘Creation Gude, Senior Counsel, at (202) 551– that would permit the Funds to register Units’’); (b) secondary market 5590, or Robert H. Shapiro, Branch as open-end management investment transactions in Fund shares to occur at Chief, at (202) 551–6821 (Division of companies and issue shares that are negotiated market prices rather than at Investment Management, Chief redeemable in Creation Units only. net asset value (‘‘NAV’’); (c) certain Counsel’s Office). Funds to pay redemption proceeds, SUPPLEMENTARY INFORMATION: The 1 Applicants request that the order apply to the under certain circumstances, more than following is a summary of the new series of the Trust as well as to additional seven days after the tender of shares for series of the Trust and any other open-end application. The complete application management investment company or series thereof redemption; (d) certain affiliated may be obtained via the Commission’s that currently exist or that may be created in the persons of a Fund to deposit securities Web site by searching for the file future (each, included in the term ‘‘Fund’’), each of into, and receive securities from, the number, or for an applicant using the which will operate as an actively-managed ETF. Fund in connection with the purchase Any Fund will (a) be advised by the Initial Adviser Company name box, at http:// or an entity controlling, controlled by, or under and redemption of Creation Units; (e) www.sec.gov/search/search.htm or by common control with the Initial Adviser (each such certain registered management calling (202) 551–8090. entity and any successor thereto is included in the investment companies and unit term ‘‘Adviser’’) and (b) comply with the terms and investment trusts outside of the same Summary of the Application conditions of the application. For purposes of the requested Order, the term ‘‘successor’’ is limited to group of investment companies as the 1. Applicants request an order that an entity that results from a reorganization into Funds (‘‘Funds of Funds’’) to acquire would allow Funds to operate as another jurisdiction or a change in the type of shares of the Funds; and (f) certain actively-managed exchange traded business organization.
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5. Applicants also request an purchases of Creation Units and the investment company involved; and (c) exemption from section 22(d) of the Act redemption procedures for in-kind the proposed transaction is consistent and rule 22c–1 under the Act as redemptions of Creation Units will be with the general purposes of the Act. secondary market trading in shares will the same for all purchases and For the Commission, by the Division of take place at negotiated prices, not at a redemptions and Deposit Instruments Investment Management, under delegated current offering price described in a and Redemption Instruments will be authority. Fund’s prospectus, and not at a price valued in the same manner as those Eduardo A. Aleman, based on NAV. Applicants state that (a) Portfolio Instruments currently held by Assistant Secretary. secondary market trading in shares does the Funds. Applicants also seek relief [FR Doc. 2017–24487 Filed 11–9–17; 8:45 am] not involve a Fund as a party and will from the prohibitions on affiliated not result in dilution of an investment transactions in section 17(a) to permit a BILLING CODE 8011–01–P in shares, and (b) to the extent different Fund to sell its shares to and redeem its prices exist during a given trading day, shares from a Fund of Funds, and to SECURITIES AND EXCHANGE or from day to day, such variances occur engage in the accompanying in-kind COMMISSION as a result of third-party market forces, transactions with the Fund of Funds.2 such as supply and demand. Therefore, The purchase of Creation Units by a [Release No. 34–82019; File No. SR–Phlx– applicants assert that secondary market Fund of Funds directly from a Fund will 2017–91] transactions in shares will not lead to be accomplished in accordance with the discrimination or preferential treatment policies of the Fund of Funds and will Self-Regulatory Organizations; Nasdaq among purchasers. Finally, applicants be based on the NAVs of the Funds. PHLX LLC; Notice of Filing and represent that share market prices will 9. Applicants also request relief to Immediate Effectiveness of Proposed be disciplined by arbitrage permit a Feeder Fund to acquire shares Rule Change To Amend Pricing opportunities, which should prevent of another registered investment Schedule Section II, Entitled Multiply shares from trading at a material company managed by the Adviser Listed Options Fees discount or premium from NAV. having substantially the same November 6, 2017. 6. With respect to Funds that hold investment objectives as the Feeder Pursuant to Section 19(b)(1) of the non-U.S. Portfolio Instruments and that Fund (‘‘Master Fund’’) beyond the Securities Exchange Act of 1934 effect creations and redemptions of limitations in section 12(d)(1)(A) and (‘‘Act’’),1 and Rule 19b–4 thereunder,2 Creation Units in kind, applicants permit the Master Fund, and any notice is hereby given that on November request relief from the requirement principal underwriter for the Master 1, 2017, Nasdaq PHLX LLC (‘‘Phlx’’ or imposed by section 22(e) in order to Fund, to sell shares of the Master Fund ‘‘Exchange’’) filed with the Securities allow such Funds to pay redemption to the Feeder Fund beyond the and Exchange Commission proceeds within fifteen calendar days limitations in section 12(d)(1)(B). (‘‘Commission’’) the proposed rule following the tender of Creation Units 10. Section 6(c) of the Act permits the change as described in Items I, II, and for redemption. Applicants assert that Commission to exempt any persons or III, below, which Items have been the requested relief would not be transactions from any provision of the prepared by the Exchange. The inconsistent with the spirit and intent of Act if such exemption is necessary or Commission is publishing this notice to section 22(e) to prevent unreasonable, appropriate in the public interest and solicit comments on the proposed rule undisclosed or unforeseen delays in the consistent with the protection of change from interested persons. actual payment of redemption proceeds. investors and the purposes fairly 7. Applicants request an exemption to intended by the policy and provisions of I. Self-Regulatory Organization’s permit Funds of Funds to acquire Fund the Act. Section 12(d)(1)(J) of the Act Statement of the Terms of Substance of shares beyond the limits of section provides that the Commission may the Proposed Rule Change 12(d)(1)(A) of the Act; and the Funds, exempt any person, security, or The Exchange proposes to amend the and any principal underwriter for the transaction, or any class or classes of Pricing Schedule, Section II, entitled Funds, and/or any broker or dealer persons, securities, or transactions, from ‘‘Multiply Listed Options Fees,’’ 3 as registered under the Exchange Act, to any provision of section 12(d)(1) if the further discussed below. sell shares to Funds of Funds beyond exemption is consistent with the public The text of the proposed rule change the limits of section 12(d)(1)(B) of the interest and the protection of investors. is available on the Exchange’s Web site Act. The application’s terms and Section 17(b) of the Act authorizes the at http://nasdaqphlx.cchwallstreet conditions are designed to, among other Commission to grant an order .com/, at the principal office of the things, help prevent any potential (i) permitting a transaction otherwise Exchange, and at the Commission’s undue influence over a Fund through prohibited by section 17(a) if it finds Public Reference Room. control or voting power, or in that (a) the terms of the proposed connection with certain services, transaction are fair and reasonable and II. Self-Regulatory Organization’s transactions, and underwritings, (ii) do not involve overreaching on the part Statement of the Purpose of, and excessive layering of fees, and (iii) of any person concerned; (b) the Statutory Basis for, the Proposed Rule overly complex fund structures, which proposed transaction is consistent with Change are the concerns underlying the limits the policies of each registered In its filing with the Commission, the in sections 12(d)(1)(A) and (B) of the Exchange included statements Act. 2 The requested relief would apply to direct sales of shares in Creation Units by a Fund to a Fund of concerning the purpose of and basis for 8. Applicants request an exemption the proposed rule change and discussed from sections 17(a)(1) and 17(a)(2) of the Funds and redemptions of those shares. Applicants, moreover, are not seeking relief from section 17(a) any comments it received on the Act to permit persons that are affiliated for, and the requested relief will not apply to, proposed rule change. The text of these persons, or second-tier affiliates, of the transactions where a Fund could be deemed an Funds, solely by virtue of certain Affiliated Person, or a Second-Tier Affiliate, of a Fund of Funds because an Adviser or an entity 1 15 U.S.C. 78s(b)(1). ownership interests, to effectuate controlling, controlled by or under common control 2 17 CFR 240.19b–4. purchases and redemptions in-kind. The with an Adviser provides investment advisory 3 This includes options overlying equities, ETFs, deposit procedures for in-kind services to that Fund of Funds. ETNs and indexes which are multiply listed.
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statements may be examined at the $0.48 per contract).10 The reduced fee transact order flow on the Exchange, places specified in Item IV below. The for Firm electronic simple orders in which order flow brings increased Exchange has prepared summaries, set Select Symbols (such reduced fee, the liquidity to the Exchange for the benefit forth in sections A, B, and C below, of ‘‘Select Firm Fee’’) is to incentivize of all Exchange participants. To the the most significant aspects of such Firms to transact more volume in Select extent the purpose of the proposed statements. Symbols, thereby attracting more order Select Firm Fee is achieved, all market flow to the Exchange. participants should benefit from the A. Self-Regulatory Organization’s The Exchange now proposes to improved market liquidity. Statement of the Purpose of, and increase the $0.37 per contract Select Statutory Basis for, the Proposed Rule Firm Fee to raise revenue for the B. Self-Regulatory Organization’s Change Exchange and help defray costs. As Statement on Burden on Competition The Exchange does not believe that 1. Purpose proposed, note 1 in Section II of the Pricing Schedule will read, ‘‘Firm the proposed rule change will impose The purpose of the proposed rule electronic simple orders in AAPL, BAC, any burden on competition not change is to amend Section II of the EEM, FB, FXI, IWM, QQQ, TWTR, VXX necessary or appropriate in furtherance Exchange’s Pricing Schedule to increase and XLF will be assessed $0.45 per of the purposes of the Act. As discussed the assessment for select Firm 4 contract.’’ above, the Exchange believes that the electronic simple orders. proposed Select Firm Fee remains 2. Statutory Basis competitive and will continue to attract As set forth in Section II of the Pricing The Exchange believes that its order flow to the Exchange. The Schedule, the Exchange currently proposal is consistent with Section 6(b) Exchange notes that it operates in a charges a Penny Pilot Options of the Act,11 in general, and furthers the highly competitive market in which Transaction Charge for electronic simple objectives of Sections 6(b)(4) and 6(b)(5) market participants can readily favor orders that is $0.48 per contract for of the Act,12 in particular, in that it competing venues if they deem fee 5 6 Professional, Broker-Dealer and Firm provides for the equitable allocation of levels at a particular venue to be 7 orders, $0.22 per contract for Specialist reasonable dues, fees and other charges excessive, or rebate opportunities 8 and Market Maker orders, and $0.00 among members and issuers and other available at other venues to be more for Customer 9 orders. In addition, the persons using any facility, and is not favorable. In such an environment, the Exchange charges a reduced Penny Pilot designed to permit unfair Exchange must continually adjust its Options Transaction Charge for Firm discrimination between customers, fees to remain competitive with other electronic simple orders in AAPL, BAC, issuers, brokers, or dealers. exchanges. For the reasons described EEM, FB, FXI, IWM, QQQ, TWTR, VXX The Exchange believes its proposal to above, the Exchange believes that the and XLF (hereinafter, ‘‘Select Symbols’’) increase the Select Firm Fee from $0.37 proposed fee changes reflect this that is $0.37 per contract (reduced from to $0.45 per contract is reasonable competitive environment. because the proposed increase will help 4 The term ‘‘Firm’’ applies to any transaction that defray costs, and remains lower than the C. Self-Regulatory Organization’s is identified by a member or member organization $0.48 per contract Penny Pilot Options Statement on Comments on the for clearing in the Firm range at OCC. Proposed Rule Change Received From 5 Transaction Charge assessed to all other The term ‘‘Professional’’ applies to transactions 13 Members, Participants, or Others for the accounts of Professionals, as defined in Firm electronic simple orders. Exchange Rule 1000(b)(14) means any person or Furthermore, the Exchange notes that No written comments were either entity that (i) is not a broker or dealer in securities, the proposed fee remains competitive solicited or received. and (ii) places more than 390 orders in listed with the fees of another options options per day on average during a calendar month 14 III. Date of Effectiveness of the for its own beneficial account(s). See Pricing market. Accordingly, the Exchange Proposed Rule Change and Timing for Schedule, Preface. believes that the proposed $0.45 per Commission Action 6 The term ‘‘Broker-Dealer’’ applies to any contract fee for Firm electronic simple transaction which is not subject to any of the other orders in Select Symbols, which The foregoing rule change has become transaction fees applicable within a particular represent high volume Penny Pilot effective pursuant to Section category. See Pricing Schedule, Preface. 19(b)(3)(A)(ii) of the Act.15 7 The term ‘‘Specialist’’ applies to transactions for options listed on the Exchange, will the account of a Specialist (as defined in Exchange continue to be competitive and attract At any time within 60 days of the Rule 1020(a)). A Specialist is an Exchange member order flow to the Exchange, to the filing of the proposed rule change, the who is registered as an options specialist pursuant benefit of all market participants. Commission summarily may to Rule 1020(a). An options Specialist includes a temporarily suspend such rule change if Remote Specialist which is defined as an options In addition, the Exchange believes the specialist in one or more classes that does not have proposed $0.45 per contract Select Firm it appears to the Commission that such a physical presence on an Exchange floor and is Fee is equitable and not unfairly action is: (i) Necessary or appropriate in approved by the Exchange pursuant to Rule 501. discriminatory because the Exchange the public interest; (ii) for the protection See Pricing Schedule, Preface. will apply the same fee to all similarly of investors; or (iii) otherwise in 8 For purposes of the Pricing Schedule, the term furtherance of the purposes of the Act. ‘‘Market Maker’’ will be utilized to describe the fees situated members. For the reasons and rebates applicable to Registered Options discussed above, the proposed fee If the Commission takes such action, the Traders (as defined in Exchange Rule 1014(b)), provides an incentive for Firms to Commission shall institute proceedings Streaming Quote Traders (as defined in Exchange to determine whether the proposed rule Rule 1014(b)(ii)(A)) and Remote Streaming Quote 10 should be approved or disapproved. Traders (as defined in Exchange Rule See note 1 in Section II of the Pricing Schedule. 1014(b)(ii)(B)). See Pricing Schedule, Preface. Select symbols represent high volume Penny Pilot options listed on the Exchange. IV. Solicitation of Comments 9 The term ‘‘Customer’’ applies to any transaction 11 that is identified by a member or member 15 U.S.C. 78f(b). Interested persons are invited to organization for clearing in the Customer range at 12 15 U.S.C. 78f(b)(4) and (5). submit written data, views, and The Options Clearing Corporation (‘‘OCC’’) which 13 See Pricing Schedule, Section II. arguments concerning the foregoing, is not for the account of a broker or dealer or for 14 See, e.g., MIAX Options Fee Schedule at: the account of a ‘‘Professional’’ (as that term is https://www.miaxoptions.com/sites/default/files/ including whether the proposed rule defined in Rule 1000(b)(14)). See Pricing Schedule, fee_schedule-files/MIAX_Options_Fee_Schedule_ Preface. 10112017.pdf. 15 15 U.S.C. 78s(b)(3)(A)(ii).
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change is consistent with the Act. submissions should refer to File II. Self-Regulatory Organization’s Comments may be submitted by any of Number SR–Phlx–2017–91 and should Statement of the Purpose of, and the following methods: be submitted on or before December 4, Statutory Basis for, the Proposed Rule 2017. Change Electronic Comments For the Commission, by the Division of • Use the Commission’s Internet In its filing with the Commission, the Trading and Markets, pursuant to delegated Exchange included statements comment form (http://www.sec.gov/ 16 authority. concerning the purpose of and basis for rules/sro.shtml); or Eduardo A. Aleman, • Send an email to rule-comments@ the proposed rule change and discussed Assistant Secretary. sec.gov. Please include File Number SR– any comments it received on the Phlx–2017–91 on the subject line. [FR Doc. 2017–24439 Filed 11–9–17; 8:45 am] proposed rule change. The text of these BILLING CODE 8011–01–P statements may be examined at the Paper Comments places specified in Item IV below. The • Send paper comments in triplicate Exchange has prepared summaries, set to Brent J. Fields, Secretary, Securities SECURITIES AND EXCHANGE forth in sections A, B, and C below, of and Exchange Commission, 100 F Street COMMISSION the most significant aspects of such NE., Washington, DC 20549–1090. statements. All submissions should refer to File [Release No. 34–82017; File No. SR– A. Self-Regulatory Organization’s Number SR–Phlx–2017–91. This file PEARL–2017–36] Statement of the Purpose of, and number should be included on the Self-Regulatory Organizations; MIAX Statutory Basis for, the Proposed Rule subject line if email is used. To help the PEARL, LLC; Notice of Filing and Change Commission process and review your Immediate Effectiveness of a Proposed 1. Purpose comments more efficiently, please use Rule Change To Amend the MIAX only one method. The Commission will PEARL Fee Schedule The Exchange proposes to make a post all comments on the Commission’s number of non-substantive, technical Internet Web site (http://www.sec.gov/ November 6, 2017. corrections to its routing fee table set rules/sro.shtml). Copies of the forth in Section 1(b) of the Fee Schedule Pursuant to Section 19(b)(1) of the submission, all subsequent to reflect recent corporate name changes Securities Exchange Act of 1934 amendments, all written statements to some of the options exchanges listed (‘‘Act’’),1 and Rule 19b–4 thereunder,2 with respect to the proposed rule in the table. notice is hereby given that on November change that are filed with the As a result of recent exchange 2, 2017, MIAX PEARL, LLC (‘‘MIAX Commission, and all written consolidation and corporate re- PEARL’’ or ‘‘Exchange’’) filed with the communications relating to the branding, some options exchanges have Securities and Exchange Commission proposed rule change between the changed their names. The names of all (‘‘Commission’’) a proposed rule change Commission and any person, other than options exchanges are set forth in the as described in Items I, II, and III below, those that may be withheld from the Exchange’s routing fee table set forth in which Items have been prepared by the public in accordance with the Section 1(b) of the Fee Schedule, which Exchange. The Commission is provisions of 5 U.S.C. 552, will be sets forth the fees for customer orders publishing this notice to solicit available for Web site viewing and that are routed to those options comments on the proposed rule change printing in the Commission’s Public exchanges for execution. Accordingly, from interested persons. Reference Room, 100 F Street NE., the Exchange proposes to update its Washington, DC 20549, on official I. Self-Regulatory Organization’s routing fee table set forth in Section 1(b) business days between the hours of Statement of the Terms of Substance of of the Fee Schedule to reflect those 10:00 a.m. and 3:00 p.m. Copies of the the Proposed Rule Change recent exchange name changes. No other filing also will be available for changes are proposed to the routing fee inspection and copying at the principal The Exchange is filing a proposal to table. Accordingly, as amended, the office of the Exchange. All comments amend the MIAX PEARL Fee Schedule routing fee table shall be as follows: received will be posted without change. (the ‘‘Fee Schedule’’). (b) Fees and Rebates for Customer Persons submitting comments are The text of the proposed rule change Orders Routed to Another Options cautioned that we do not redact or edit is available on the Exchange’s Web site Exchange MIAX PEARL will assess a personal identifying information from at http://www.miaxoptions.com/rule- Routing Fee to market participants on comment submissions. You should filings/pearl at MIAX PEARL’s principal all orders routed to and executed on an submit only information that you wish office, and at the Commission’s Public away market as set forth in the table to make available publicly. All Reference Room. below.
Description Fees
Routed, Priority Customer, Penny Pilot, to: NYSE American, BOX, Cboe, Cboe EDGX Options , Nasdaq MRX, MIAX OPTIONS, Nasdaq PHLX (except SPY), Nasdaq BX Options ...... $0.15 Routed, Priority Customer, Penny Pilot, to: NYSE Arca Options, Cboe BZX Options, Cboe C2, Nasdaq GEMX, Nasdaq ISE, NOM, Nasdaq PHLX (SPY only) ...... 0.65 Routed, Priority Customer, Non-Penny Pilot, to: NYSE American, BOX, Cboe, Cboe EDGX Options, Nasdaq ISE, Nasdaq MRX, MIAX OPTIONS, Nasdaq PHLX, Nasdaq BX Options ...... 0.15 Routed, Priority Customer, Non-Penny Pilot, to: NYSE Arca Options, Cboe BZX Options, Cboe C2, Nasdaq GEMX, NOM ...... 0.97 Routed, Public Customer that is not a Priority Customer, Penny Pilot, to: NYSE American, NYSE Arca Options, Cboe BZX Op- tions, BOX, Cboe, Cboe C2, Cboe EDGX Options, Nasdaq GEMX, Nasdaq ISE, Nasdaq MRX, MIAX OPTIONS, NOM, Nasdaq PHLX, Nasdaq BX Options ...... 0.65
16 17 CFR 200.30–3(a)(12). 1 15 U.S.C. 78s(b)(1). 2 17 CFR 240.19b–4.
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Description Fees
Routed, Public Customer that is not a Priority Customer, Non-Penny Pilot, to: NYSE American ...... 0.65 Routed, Public Customer that is not a Priority Customer, Non-Penny Pilot, to: NYSE Arca Options, Cboe BZX Options, Cboe C2, Nasdaq GEMX, Nasdaq MRX, Nasdaq BX Options ...... 1.20 Routed (Public Customer that is not a Priority Customer), Non-Penny Pilot, to: BOX, Cboe, Cboe EDGX Options, Nasdaq ISE, MIAX OPTIONS, NOM, Nasdaq PHLX ...... 0.97
2. Statutory Basis of the purposes of the Act. The Paper Comments proposed changes to update its routing The Exchange believes that its • fee table set forth in Section 1(b) of the Send paper comments in triplicate proposal to amend its Fee Schedule is to Brent J. Fields, Secretary, Securities consistent with Section 6(b) of the Act 3 Fee Schedule to reflect recent exchange and Exchange Commission, 100 F Street in general, and furthers the objectives of name changes will have no impact on Section 6(b)(4) of the Act,4 in that it is competition as they are not designed to NE., Washington, DC 20549–1090. an equitable allocation of reasonable address any competitive issues but All submissions should refer to File fees and other charges among Exchange rather are designed to make non- Number SR–PEARL–2017–36. This file members and other persons using its substantive technical corrections and number should be included on the 5 update the Exchange’s Fee Schedule. facilities, and 6(b)(5) of the Act, in that subject line if email is used. To help the it is designed to prevent fraudulent and C. Self-Regulatory Organization’s Commission process and review your manipulative acts and practices, to Statement on Comments on the comments more efficiently, please use promote just and equitable principles of Proposed Rule Change Received From only one method. The Commission will trade, to foster cooperation and Members, Participants, or Others post all comments on the Commission’s coordination with persons engaged in Internet Web site (http://www.sec.gov/ facilitating transactions in securities, to Written comments were neither rules/sro.shtml). Copies of the remove impediments to and perfect the solicited nor received. mechanisms of a free and open market submission, all subsequent and a national market system and, in III. Date of Effectiveness of the amendments, all written statements general, to protect investors and the Proposed Rule Change and Timing for with respect to the proposed rule public interest. Commission Action change that are filed with the The Exchange believes the proposed Commission, and all written The foregoing rule change has become changes to update its routing fee table communications relating to the effective pursuant to Section set forth in Section 1(b) of the Fee proposed rule change between the 19(b)(3)(A)(ii) of the Act,6 and Rule Schedule to reflect recent exchange Commission and any person, other than 19b–4(f)(2) 7 thereunder. At any time name changes promote just and those that may be withheld from the within 60 days of the filing of the equitable principles of trade and remove proposed rule change, the Commission public in accordance with the impediments to and perfect the summarily may temporarily suspend provisions of 5 U.S.C. 552, will be mechanism of a free and open market available for Web site viewing and and a national market system because such rule change if it appears to the Commission that such action is printing in the Commission’s Public the proposed rule change makes non- Reference Room, 100 F Street NE., substantive technical corrections and necessary or appropriate in the public interest, for the protection of investors, Washington, DC 20549, on official updates the Exchange’s Fee Schedule. business days between the hours of None of the name changes alter the or otherwise in furtherance of the 10:00 a.m. and 3:00 p.m. Copies of the application of any fees or rebates on the purposes of the Act. If the Commission filing also will be available for Fee Schedule. As such, the proposed takes such action, the Commission shall amendments would foster cooperation institute proceedings to determine inspection and copying at the principal and coordination with persons engaged whether the proposed rule should be office of the Exchange. All comments in facilitating transactions in securities approved or disapproved. received will be posted without change. Persons submitting comments are and would remove impediments to and IV. Solicitation of Comments perfect the mechanism of a free and cautioned that we do not redact or edit open market and a national exchange Interested persons are invited to personal identifying information from system. In particular, the Exchange submit written data, views, and comment submissions. You should believes that the proposed changes will arguments concerning the foregoing, submit only information that you wish provide greater clarity to Members and including whether the proposed rule to make available publicly. All the public regarding the Exchange’s change is consistent with the Act. submissions should refer to File Rules. It is in the public interest for Comments may be submitted by any of Number SR–PEARL–2017–36 and rules to be accurate and concise so as to the following methods: should be submitted on or before eliminate the potential for confusion. Electronic Comments December 4, 2017. B. Self-Regulatory Organization’s For the Commission, by the Division of • Statement on Burden on Competition Use the Commission’s Internet Trading and Markets, pursuant to delegated comment form (http://www.sec.gov/ authority.8 MIAX PEARL does not believe that rules/sro.shtml); or the proposed rule changes will impose Eduardo A. Aleman, • any burden on competition not Send an email to rule-comments@ Assistant Secretary. necessary or appropriate in furtherance sec.gov. Please include File Number SR– [FR Doc. 2017–24437 Filed 11–9–17; 8:45 am] PEARL–2017–36 on the subject line. BILLING CODE 8011–01–P 3 15 U.S.C. 78f(b). 4 15 U.S.C. 78f(b)(4). 6 15 U.S.C. 78s(b)(3)(A)(ii). 5 15 U.S.C. 78f(b)(1) and (b)(5). 7 17 CFR 240.19b–4(f)(2). 8 17 CFR 200.30–3(a)(12).
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SECURITIES AND EXCHANGE A. Self-Regulatory Organization’s Monthly recurring COMMISSION Statement of the Purpose of, and the Third Party Data Feed connectivity fee Statutory Basis for, the Proposed Rule per Third Party Data Feed [Release No. 34–82018; File No. SR–NYSE– Change 2017–55] 1. Purpose Global OTC ...... $100 ICE Data Global Index ... 100 Self-Regulatory Organizations; New The Exchange proposes to amend its ICE Data Services Con- 4 York Stock Exchange LLC; Notice of Price List relating to co-location solidated Feed ≤ 100 Filing and Immediate Effectiveness of services to reflect the name change of a Mb ...... 200 Proposed Rule Change To Amend Its third party data feed. The Exchange proposes to implement the proposed Price List Relating to Co-Location General change on November 1, 2017. As is the case with all Exchange co- Services To Reflect the Name Change The co-location services that the of a Third Party Data Feed 5 location arrangements, (i) neither a User Exchange offers Users include nor any of the User’s customers would November 6, 2017. connectivity to third party data feeds be permitted to submit orders directly to from third party markets and other Pursuant to Section 19(b)(1) 1 of the the Exchange unless such User or content service providers (‘‘Third Party customer is a member organization, a Securities Exchange Act of 1934 (the Data Feeds’’).6 The list of Third Party ‘‘Act’’) 2 and Rule 19b–4 thereunder,3 Sponsored Participant or an agent Data Feeds is set forth in the Price List, thereof (e.g., a service bureau providing notice is hereby given that, on October 7 and includes the NYSE Global Index. order entry services); (ii) use of the co- 25, 2017, New York Stock Exchange The name of NYSE Global Index is location services proposed herein would LLC (‘‘NYSE’’ or the ‘‘Exchange’’) filed changing to ‘‘ICE Data Global Index.’’ be completely voluntary and available with the Securities and Exchange The Exchange accordingly proposes to to all Users on a non-discriminatory Commission (‘‘Commission’’) the amend the Price List to reflect the basis; 8 and (iii) a User would only incur change. The Exchange does not propose proposed rule change as described in one charge for the particular co-location to change the applicable monthly Items I, II, and III below, which Items service described herein, regardless of recurring connectivity fee. The have been prepared by the self- whether the User connects only to the Exchange proposes the following regulatory organization. The Exchange or to the Exchange and one or Commission is publishing this notice to changes: 9 • In the third sentence under both the Affiliate SROs. solicit comments on the proposed rule The proposed change is not otherwise ‘‘Connectivity to Third Party Data change from interested persons. intended to address any other issues Feeds,’’ the reference to ‘‘NYSE Global relating to co-location services and/or I. Self-Regulatory Organization’s Index’’ would be changed to ‘‘ICE Data related fees, and the Exchange is not Statement of the Terms of Substance of Global Index.’’ aware of any problems that Users would the Proposed Rule Change • In the table under ‘‘Connectivity to Third Party Data Feeds,’’ the line listing have in complying with the proposed The Exchange proposes to amend its ‘‘NYSE Global Index’’ and the related change. Price List relating to co-location services $100 monthly recurring connectivity fee 2. Statutory Basis to reflect the name change of a third would be deleted, and a new line added, The Exchange believes that the party data feed. The Exchange proposes as follows (additions italicized): proposed rule change is consistent with to implement the proposed change on Section 6(b) of the Act,10 in general, and November 1, 2017. The proposed rule 4 The Exchange initially filed rule changes relating to its co-location services with the furthers the objectives of Sections change is available on the Exchange’s 6(b)(5) of the Act,11 in particular, Web site at www.nyse.com, at the Commission in 2010. See Securities Exchange Act Release No. 62960 (September 21, 2010), 75 FR because it is designed to prevent principal office of the Exchange, and at 59310 (September 27, 2010) (SR–NYSE–2010–56). fraudulent and manipulative acts and the Commission’s Public Reference The Exchange operates a data center in Mahwah, practices, to promote just and equitable Room. New Jersey (the ‘‘data center’’) from which it provides co-location services to Users. principles of trade, to foster cooperation II. Self-Regulatory Organization’s 5 For purposes of the Exchange’s co-location and coordination with persons engaged Statement of the Purpose of, and services, a ‘‘User’’ means any market participant in regulating, clearing, settling, that requests to receive co-location services directly processing information with respect to, Statutory Basis for, the Proposed Rule from the Exchange. See Securities Exchange Act Change Release No. 76008 (September 29, 2015), 80 FR 60190 (October 5, 2015) (SR–NYSE–2015–40). As 8 As is currently the case, Users that receive co- In its filing with the Commission, the specified in the Price List, a User that incurs co- location services from the Exchange will not receive location fees for a particular co-location service any means of access to the Exchange’s trading and self-regulatory organization included pursuant thereto would not be subject to co-location execution systems that is separate from, or superior statements concerning the purpose of, fees for the same co-location service charged by the to, that of other Users. In this regard, all orders sent and basis for, the proposed rule change Exchange’s affiliates NYSE American LLC (‘‘NYSE to the Exchange enter the Exchange’s trading and and discussed any comments it received American’’) and NYSE Arca, Inc. (‘‘NYSE Arca’’ execution systems through the same order gateway, and, together with NYSE American, the ‘‘Affiliate regardless of whether the sender is co-located in the on the proposed rule change. The text SROs’’). See Securities Exchange Act Release No. data center or not. In addition, co-located Users do of those statements may be examined at 70206 (August 15, 2013), 78 FR 51765 (August 21, not receive any market data or data service product the places specified in Item IV below. 2013) (SR–NYSE–2013–59). that is not available to all Users, although Users that 6 receive co-location services normally would expect The Exchange has prepared summaries, See Securities Exchange Act Release No. 80311 (March 24, 2017), 82 FR 15741 (March 30, 2017) reduced latencies in sending orders to, and set forth in sections A, B, and C below, (SR–NYSE–2016–45). receiving market data from, the Exchange. of the most significant parts of such 7 The NYSE Global Index feed includes index and 9 See SR–NYSE–2013–59, supra note 5 at 51766. statements. exchange traded product valuations data, with data The Affiliate SROs have also submitted drawn from the Exchange, the Affiliate SROS, and substantially the same proposed rule change to third party exchanges. Because it includes third propose the changes described herein. See SR– 1 15 U.S.C.78s(b)(1). party data, the NYSE Global Index feed is NYSEAmer–2017–28 and SR–NYSEArca–2017–124. 2 15 U.S.C. 78a. considered a Third Party Data Feed. See id., at 10 15 U.S.C. 78f(b). 3 17 CFR 240.19b–4. 15749. 11 15 U.S.C. 78f(b)(5).
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and facilitating transactions in temporarily suspend such rule change if cautioned that we do not redact or edit securities, to remove impediments to, it appears to the Commission that such personal identifying information from and perfect the mechanisms of, a free action is necessary or appropriate in the comment submissions. You should and open market and a national market public interest, for the protection of submit only information that you wish system and, in general, to protect investors, or otherwise in furtherance of to make available publicly. All investors and the public interest. the purposes of the Act. If the submissions should refer to File The non-substantive change proposed Commission takes such action, the Number SR–NYSE–2017–55 and should is intended solely to reflect the name Commission shall institute proceedings be submitted on or before December 4, change of ‘‘NYSE Global Index’’ to ‘‘ICE under Section 19(b)(2)(B) 15 of the Act to 2017. Data Global Index.’’ The proposed rule determine whether the proposed rule For the Commission, by the Division of change, therefore would remove change should be approved or Trading and Markets, pursuant to delegated impediments to, and perfect the disapproved. authority.16 mechanisms of, a free and open market IV. Solicitation of Comments Eduardo A. Aleman, and a national market system and, in Assistant Secretary. general, protect investors and the public Interested persons are invited to submit written data, views, and [FR Doc. 2017–24438 Filed 11–9–17; 8:45 am] interest because it would update the BILLING CODE 8011–01–P Price List to reflect the name change, arguments concerning the foregoing, increasing the clarity and transparency including whether the proposed rule change is consistent with the Act. of the Exchange’s rules. SECURITIES AND EXCHANGE Comments may be submitted by any of For the reasons above, the proposed COMMISSION changes would not unfairly discriminate the following methods: between or among market participants [Release No. 34–82020; File No. SR–NYSE– Electronic Comments 2017–56] that are otherwise capable of satisfying • Use the Commission’s Internet any applicable co-location fees, comment form (http://www.sec.gov/ Self-Regulatory Organizations; New requirements, terms and conditions rules/sro.shtml); or York Stock Exchange LLC; Notice of established from time to time by the • Send an email to rule-comments@ Filing and Immediate Effectiveness of Exchange. sec.gov. Please include File Number SR– Proposed Rule Change To Amend For these reasons, the Exchange NYSE–2017–55 on the subject line. Certain of Its Listing Fees believes that the proposal is consistent with the Act. Paper Comments November 6, 2017. • Pursuant to Section 19(b)(1) of the B. Self-Regulatory Organization’s Send paper comments in triplicate Securities Exchange Act of 1934 Statement on Burden on Competition to Secretary, Securities and Exchange Commission, 100 F Street NE., (‘‘Act’’) 1 and Rule 19b–4 thereunder,2 In accordance with Section 6(b)(8) of Washington, DC 20549–1090. notice is hereby given that on October the Act,12 the Exchange believes that the All submissions should refer to File 30, 2017, New York Stock Exchange proposed rule change will not impose Number SR–NYSE–2017–55. This file LLC (‘‘NYSE’’ or the ‘‘Exchange’’) filed any burden on competition that is not number should be included on the with the Securities and Exchange necessary or appropriate in furtherance subject line if email is used. To help the Commission (‘‘Commission’’) the of the purposes of the Act because it is Commission process and review your proposed rule change as described in solely intended to reflect the name comments more efficiently, please use Items I, II, and III below, which Items change of ‘‘NYSE Global Index’’ to ‘‘ICE only one method. The Commission will have been prepared by the Exchange. Data Global Index.’’ No other change is post all comments on the Commission’s The Commission is publishing this proposed. Internet Web site (http://www.sec.gov/ notice to solicit comments on the C. Self-Regulatory Organization’s rules/sro.shtml). Copies of the proposed rule change from interested Statement on Comments on the submission, all subsequent persons. Proposed Rule Change Received From amendments, all written statements I. Self-Regulatory Organization’s Members, Participants, or Others with respect to the proposed rule Statement of the Terms of Substance of No written comments were solicited change that are filed with the the Proposed Rule Change or received with respect to the proposed Commission, and all written The Exchange proposes to amend rule change. communications relating to the certain of its listing fees. The proposed proposed rule change between the rule change is available on the III. Date of Effectiveness of the Commission and any person, other than Exchange’s Web site at www.nyse.com, Proposed Rule Change and Timing for those that may be withheld from the at the principal office of the Exchange, Commission Action public in accordance with the and at the Commission’s Public The foregoing rule change is effective provisions of 5 U.S.C. 552, will be Reference Room. upon filing pursuant to Section available for Web site viewing and 19(b)(3)(A) 13 of the Act and printing in the Commission’s Public II. Self-Regulatory Organization’s subparagraph (f)(2) of Rule 19b–4 14 Reference Room, 100 F Street NE., Statement of the Purpose of, and thereunder, because it establishes a due, Washington, DC 20549 on official Statutory Basis for, the Proposed Rule fee, or other charge imposed by the business days between the hours of Change Exchange. 10:00 a.m. and 3:00 p.m. Copies of the In its filing with the Commission, the At any time within 60 days of the filing also will be available for self-regulatory organization included filing of such proposed rule change, the inspection and copying at the principal statements concerning the purpose of, Commission summarily may office of the Exchange. All comments and basis for, the proposed rule change received will be posted without change. 12 15 U.S.C. 78f(b)(8). Persons submitting comments are 16 17 CFR 200.30–3(a)(12). 13 15 U.S.C. 78s(b)(3)(A). 1 15 U.S.C. 78s(b)(1). 14 17 CFR 240.19b–4(f)(2). 15 15 U.S.C. 78s(b)(2)(B). 2 17 CFR 240.19b–4.
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and discussed any comments it received the corresponding value of such listing unfairly discriminatory towards any on the proposed rule change. The text to issuers. individual issuer. The Exchange of those statements may be examined at The Exchange also proposes to believes it is consistent with Section the places specified in Item IV below. remove a number of references 6(b)(5) of the Act to apply different fees The Exchange has prepared summaries, throughout Chapter Nine to (i) fees that to bonds of companies that do not have set forth in sections A, B, and C below, are no longer applicable as they were their equity securities listed on the of the most significant parts of such superseded by new fee rates specified in NYSE than to companies with NYSE- statements. the rule text and (ii) effectiveness dates listed equity securities and their of revised fee levels with respect to A. Self-Regulatory Organization’s affiliates, as there is a greater regulatory which the effective date has now and administrative burden associated Statement of the Purpose of, and the passed. Statutory Basis for, the Proposed Rule with listing bonds of companies with Change 2. Statutory Basis which the Exchange does not otherwise have a regulatory or listing relationship. 1. Purpose The Exchange believes that the proposed rule change is consistent with B. Self-Regulatory Organization’s The Exchange proposes to amend Section 6(b) of the Act,5 in general, and Statement on Burden on Competition Chapter Nine of the Manual to amend furthers the objectives of Section certain of its listing fee provisions. The The Exchange does not believe that 6(b)(4) 6 of the Act, in particular, in that amended fees will take effect in the the proposed rule change will impose it is designed to provide for the 2018 calendar year. The following are any burden on competition that is not equitable allocation of reasonable dues, the proposed fee increases: necessary or appropriate in furtherance • For certain listed securities, the per fees, and other charges. The Exchange of the purposes of the Act. The share fee would increase from $0.00105 also believes that the proposed rule proposed rule change is designed to 3 change is consistent with Section 6(b)(5) ensure that the fees charged by the per share to $0.00108. 7 • The minimum annual fee of the Act, in that it is designed to Exchange accurately reflect the services applicable to the primary class of promote just and equitable principles of provided and benefits realized by listed common shares (including Equity trade, to foster cooperation and companies. The market for listing Investment Tracking Stock) or the coordination with persons engaged in services is extremely competitive. Each primary class of preferred stock (if no regulating, clearing, settling, processing listing exchange has a different fee class of common shares is listed) listed information with respect to, and schedule that applies to issuers seeking under Section 703.05 [sic] would facilitating transactions in securities, to to list securities on its exchange. Issuers increase from $59,500 to $65,000. remove impediments to and perfect the have the option to list their securities on • The minimum annual fee mechanism of a free and open market these alternative venues based on the applicable to structured products listed and a national market system, and, in fees charged and the value provided by under Section 703.19 [sic] would general, to protect investors and the each listing. Because issuers have a increase from $20,000 to $25,000. public interest and is not designed to choice to list their securities on a • The initial and annual listing fees permit unfair discrimination between different national securities exchange, for debt listed under Section 102.03 and customers, issuers, brokers, or dealers. the Exchange does not believe that the 103.05 of NYSE equity issuers and The Exchange believes that it is proposed fee changes impose a burden affiliated companies would each reasonable to amend Chapter Nine of on competition. increase from $20,000 to $25,000. the Manual to increase the various • The initial and annual listing fees listing fees as set forth above. In that C. Self-Regulatory Organization’s for debt listed under Section 102.03 and regard, the Exchange notes that it Statement on Comments on the 103.05 of companies other than NYSE continues to improve and increase the Proposed Rule Change Received From equity issuers and affiliated companies services it provides to listed companies. Members, Participants, or Others would increase from $40,000 to These improvements include the No written comments were solicited $45,000.4 continued development and or received with respect to the proposed • The initial and annual listing fees enhancement of an interactive web- rule change. for securities (including short-term based platform designed to improve III. Date of Effectiveness of the securities) that list under the debt communication between the Exchange Proposed Rule Change and Timing for standard in Section 703.19 and trade on and listed companies, the availability to Commission Action NYSE Bonds would increase from listed companies of the Exchange’s new $20,000 to $25,000. state-of-the-art conference facilities at 11 The foregoing rule change is effective As described below, the Exchange Wall Street, and continued development upon filing pursuant to Section proposes to make the aforementioned and content in an investor relations tool 19(b)(3)(A) 8 of the Act and fee increases to better reflect the available to all listed companies which subparagraph (f)(2) of Rule 19b–4 9 Exchange’s costs related to listing the provides companies with information thereunder, because it establishes a due, above-referenced types of securities and enabling them to better understand the fee, or other charge imposed by the trading and ownership of their Exchange. 3 The affected securities are as follows: Primary securities. At any time within 60 days of the class of common shares (including Equity The Exchange believes that the filing of such proposed rule change, the Investment Tracking Stock); each additional class of proposed fee increases are equitably Commission summarily may common shares (including tracking stock); primary class of preferred stock (if no class of common allocated because the per share fee temporarily suspend such rule change if shares is listed); each additional class of preferred increase will be the same for all issuers it appears to the Commission that such stock (whether primary class is common stock or on the Exchange. Therefore, the action is necessary or appropriate in the preferred stock); each class of warrants; structured proposed fee increases will not be public interest, for the protection of products listed under Section 703.19 [sic]; and short term securities. investors, or otherwise in furtherance of 4 Domestic debt of issuers not subject to 5 15 U.S.C. 78f(b). registration under the Act is exempt from all listing 6 15 U.S.C. 78f(b)(4). 8 15 U.S.C. 78s(b)(3)(A). fees. 7 15 U.S.C. 78f(b)(5). 9 17 CFR 240.19b–4(f)(2).
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the purposes of the Act. If the submissions should refer to File II. Self-Regulatory Organization’s Commission takes such action, the Number SR–NYSE–2017–56, and Statement of the Purpose of, and Commission shall institute proceedings should be submitted on or before Statutory Basis for, the Proposed Rule under Section 19(b)(2)(B) 10 of the Act to December 4, 2017. Change determine whether the proposed rule For the Commission, by the Division of In its filing with the Commission, the change should be approved or Trading and Markets, pursuant to delegated self-regulatory organization included disapproved. authority.11 statements concerning the purpose of, IV. Solicitation of Comments Eduardo A. Aleman, and basis for, the proposed rule change Interested persons are invited to Assistant Secretary. and discussed any comments it received submit written data, views, and [FR Doc. 2017–24440 Filed 11–9–17; 8:45 am] on the proposed rule change. The text arguments concerning the foregoing, BILLING CODE 8011–01–P of those statements may be examined at including whether the proposed rule the places specified in Item IV below. change is consistent with the Act. The Exchange has prepared summaries, Comments may be submitted by any of SECURITIES AND EXCHANGE set forth in sections A, B, and C below, the following methods: COMMISSION of the most significant parts of such statements. Electronic Comments [Release No. 34–82016; File No. SR– • A. Self-Regulatory Organization’s Use the Commission’s Internet NYSEARCA–2017–124] Statement of the Purpose of, and the comment form (http://www.sec.gov/ Self-Regulatory Organizations; NYSE Statutory Basis for, the Proposed Rule rules/sro.shtml); or Change • Send an email to rule-comments@ Arca, Inc.; Notice of Filing and sec.gov. Please include File Number SR– Immediate Effectiveness of Proposed 1. Purpose NYSE–2017–56 on the subject line. Rule Change To Amend the NYSE Arca The Exchange proposes to amend the Options Fees and Charges Schedule Paper Comments Fee Schedules relating to co-location 4 and the NYSE Arca Equities Fees and services to reflect the name change of a • Send paper comments in triplicate Charges Schedule Relating to Co- third party data feed. The Exchange to Brent J. Fields, Secretary, Securities Location Services To Reflect the Name proposes to implement the proposed and Exchange Commission, 100 F Street Change of a Third Party Data Feed change on November 1, 2017. NE., Washington, DC 20549–1090. November 6, 2017. The co-location services that the All submissions should refer to File Exchange offers Users 5 include 1 Number SR–NYSE–2017–56. This file Pursuant to Section 19(b)(1) of the connectivity to third party data feeds number should be included on the Securities Exchange Act of 1934 (the from third party markets and other 2 3 subject line if email is used. To help the ‘‘Act’’) and Rule 19b–4 thereunder, content service providers (‘‘Third Party Commission process and review your notice is hereby given that, on October Data Feeds’’).6 The list of Third Party comments more efficiently, please use 25, 2017, NYSE Arca, Inc. (‘‘Exchange’’ Data Feeds is set forth in the Fee only one method. The Commission will or ‘‘NYSE Arca’’) filed with the Schedules, and includes the NYSE post all comments on the Commission’s Securities and Exchange Commission Global Index.7 Internet Web site (http://www.sec.gov/ (‘‘Commission’’) the proposed rule The name of NYSE Global Index is rules/sro.shtml). Copies of the change as described in Items I, II, and changing to ‘‘ICE Data Global Index.’’ submission, all subsequent III below, which Items have been amendments, all written statements prepared by the self-regulatory 4 The Exchange initially filed rule changes with respect to the proposed rule organization. The Commission is relating to its co-location services with the change that are filed with the publishing this notice to solicit Commission in 2010. See Securities Exchange Act Commission, and all written comments on the proposed rule change Release No. 63275 (November 8, 2010), 75 FR 70048 (November 16, 2010) (SR–NYSEArca–2010–100). communications relating to the from interested persons. The Exchange operates a data center in Mahwah, proposed rule change between the New Jersey (the ‘‘data center’’) from which it I. Self-Regulatory Organization’s Commission and any person, other than provides co-location services to Users. Statement of the Terms of Substance of 5 those that may be withheld from the For purposes of the Exchange’s co-location the Proposed Rule Change services, a ‘‘User’’ means any market participant public in accordance with the that requests to receive co-location services directly provisions of 5 U.S.C. 552, will be The Exchange proposes to amend the from the Exchange. See Securities Exchange Act available for Web site viewing and NYSE Arca Options Fees and Charges Release No. 76010 (September 29, 2015), 80 FR printing in the Commission’s Public 60197 (October 5, 2015) (SR–NYSEArca–2015–82). schedule and the NYSE Arca Equities As specified in the Price List, a User that incurs co- Reference Room, 100 F Street NE., Fees and Charges schedule (together, the location fees for a particular co-location service Washington, DC 20549 on official ‘‘Fee Schedules’’) relating to co-location pursuant thereto would not be subject to co-location business days between the hours of services to reflect the name change of a fees for the same co-location service charged by the 10:00 a.m. and 3:00 p.m. Copies of such Exchange’s affiliates New York Stock Exchange LLC third party data feed. The Exchange (‘‘NYSE LLC’’) and NYSE American LLC (‘‘NYSE filing also will be available for proposes to implement the proposed American’’ and, together with NYSE LLC, the inspection and copying at the principal change on November 1, 2017. The ‘‘Affiliate SROs’’). See Securities Exchange Act office of the Exchange. All comments proposed rule change is available on the Release No. 70173 (August 13, 2013), 78 FR 50459 received will be posted without change. Exchange’s Web site at www.nyse.com, (August 19, 2013) (SR–NYSEArca–2013–80). Persons submitting comments are 6 See Securities Exchange Act Release No. 80310 at the principal office of the Exchange, (March 24, 2017), 82 FR 15763 (March 30, 2017) cautioned that we do not redact or edit and at the Commission’s Public (SR–NYSEArca–2016–89). personal identifying information from Reference Room. 7 The NYSE Global Index feed includes index and comment submissions. You should exchange traded product valuations data, with data drawn from the Exchange, the Affiliate SROS, and submit only information that you wish 11 17 CFR 200.30–3(a)(12). third party exchanges. Because it includes third to make available publicly. All 1 15 U.S.C. 78s(b)(1). party data, the NYSE Global Index feed is 2 15 U.S.C. 78a. considered a Third Party Data Feed. See id., at 10 15 U.S.C. 78s(b)(2)(B). 3 17 CFR 240.19b–4. 15771.
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The Exchange accordingly proposes to related fees, and the Exchange is not C. Self-Regulatory Organization’s amend the Fee Schedules to reflect the aware of any problems that Users would Statement on Comments on the change. The Exchange does not propose have in complying with the proposed Proposed Rule Change Received From to change the applicable monthly change. Members, Participants, or Others recurring connectivity fee. The 2. Statutory Basis No written comments were solicited Exchange proposes the following or received with respect to the proposed changes: The Exchange believes that the rule change. • In the third sentence under proposed rule change is consistent with III. Date of Effectiveness of the ‘‘Connectivity to Third Party Data 10 Feeds,’’ the reference to ‘‘NYSE Global Section 6(b) of the Act, in general, and Proposed Rule Change and Timing for Index’’ would be changed to ‘‘ICE Data furthers the objectives of Sections Commission Action 6(b)(5) of the Act,11 in particular, Global Index.’’ The foregoing rule change is effective because it is designed to prevent • In the table under ‘‘Connectivity to upon filing pursuant to Section Third Party Data Feeds,’’ the line listing fraudulent and manipulative acts and 19(b)(3)(A) 13 of the Act and ‘‘NYSE Global Index’’ and the related practices, to promote just and equitable subparagraph (f)(2) of Rule 19b–4 14 $100 monthly recurring connectivity fee principles of trade, to foster cooperation thereunder, because it establishes a due, would be deleted, and a new line added, and coordination with persons engaged fee, or other charge imposed by the as follows (additions italicized): in regulating, clearing, settling, Exchange. processing information with respect to, At any time within 60 days of the Monthly and facilitating transactions in filing of such proposed rule change, the recurring Third Party Data Feed connectivity fee securities, to remove impediments to, Commission summarily may per Third Party and perfect the mechanisms of, a free temporarily suspend such rule change if Data Feed and open market and a national market it appears to the Commission that such system and, in general, to protect action is necessary or appropriate in the Global OTC ...... $100 investors and the public interest. public interest, for the protection of ICE Data Global Index ... 100 investors, or otherwise in furtherance of ICE Data Services Con- The non-substantive change proposed the purposes of the Act. If the solidated Feed ≤ 100 is intended solely to reflect the name Commission takes such action, the Mb ...... 200 change of ‘‘NYSE Global Index’’ to ‘‘ICE Commission shall institute proceedings Data Global Index.’’ The proposed rule under Section 19(b)(2)(B) 15 of the Act to General change, therefore would remove determine whether the proposed rule As is the case with all Exchange co- impediments to, and perfect the change should be approved or location arrangements, (i) neither a User mechanisms of, a free and open market disapproved. nor any of the User’s customers would and a national market system and, in be permitted to submit orders directly to general, protect investors and the public IV. Solicitation of Comments the Exchange unless such User or interest because it would update the Fee Interested persons are invited to customer is a member organization, a Schedules to reflect the name change, submit written data, views, and Sponsored Participant or an agent increasing the clarity and transparency arguments concerning the foregoing, thereof (e.g., a service bureau providing of the Exchange’s rules. including whether the proposed rule order entry services); (ii) use of the co- For the reasons above, the proposed change is consistent with the Act. location services proposed herein would changes would not unfairly discriminate Comments may be submitted by any of be completely voluntary and available between or among market participants the following methods: to all Users on a non-discriminatory that are otherwise capable of satisfying Electronic Comments basis; 8 and (iii) a User would only incur any applicable co-location fees, one charge for the particular co-location • Use the Commission’s Internet requirements, terms and conditions service described herein, regardless of comment form (http://www.sec.gov/ established from time to time by the whether the User connects only to the rules/sro.shtml); or Exchange or to the Exchange and one or Exchange. • Send an email to rule-comments@ both the Affiliate SROs.9 For these reasons, the Exchange sec.gov. Please include File Number SR– The proposed change is not otherwise believes that the proposal is consistent NYSEARCA–2017–124 on the subject intended to address any other issues with the Act. line. relating to co-location services and/or B. Self-Regulatory Organization’s Paper Comments • 8 As is currently the case, Users that receive co- Statement on Burden on Competition Send paper comments in triplicate location services from the Exchange will not receive to Secretary, Securities and Exchange any means of access to the Exchange’s trading and In accordance with Section 6(b)(8) of Commission, 100 F Street NE., execution systems that is separate from, or superior the Act,12 the Exchange believes that the Washington, DC 20549–1090. to, that of other Users. In this regard, all orders sent proposed rule change will not impose to the Exchange enter the Exchange’s trading and All submissions should refer to File execution systems through the same order gateway, any burden on competition that is not Number SR–NYSEARCA–2017–124. regardless of whether the sender is co-located in the necessary or appropriate in furtherance This file number should be included on data center or not. In addition, co-located Users do of the purposes of the Act because it is the subject line if email is used. To help not receive any market data or data service product solely intended to reflect the name that is not available to all Users, although Users that the Commission process and review receive co-location services normally would expect change of ‘‘NYSE Global Index’’ to ‘‘ICE your comments more efficiently, please reduced latencies in sending orders to, and Data Global Index.’’ No other change is use only one method. The Commission receiving market data from, the Exchange. proposed. will post all comments on the 9 See 78 FR 50459, supra note 5, at 50459. The Affiliate SROs have also submitted substantially the same proposed rule change to propose the changes 10 15 U.S.C. 78f(b). 13 15 U.S.C. 78s(b)(3)(A). described herein. See SR–NYSE–2017–55 and SR– 11 15 U.S.C. 78f(b)(5). 14 17 CFR 240.19b–4(f)(2). NYSEAMER–2017–28. 12 15 U.S.C. 78f(b)(8). 15 15 U.S.C. 78s(b)(2)(B).
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Commission’s Internet Web site (http:// with the Securities and Exchange connectivity to third party data feeds www.sec.gov/rules/sro.shtml). Copies of Commission (‘‘Commission’’) the from third party markets and other the submission, all subsequent proposed rule change as described in content service providers (‘‘Third Party amendments, all written statements Items I, II, and III below, which Items Data Feeds’’).6 The list of Third Party with respect to the proposed rule have been prepared by the self- Data Feeds is set forth in the Price List change that are filed with the regulatory organization. The and Fee Schedule, and includes the Commission, and all written Commission is publishing this notice to NYSE Global Index.7 communications relating to the solicit comments on the proposed rule The name of NYSE Global Index is proposed rule change between the change from interested persons. changing to ‘‘ICE Data Global Index.’’ Commission and any person, other than The Exchange accordingly proposes to those that may be withheld from the I. Self-Regulatory Organization’s amend the Price List and Fee Schedule public in accordance with the Statement of the Terms of Substance of to reflect the change. The Exchange does provisions of 5 U.S.C. 552, will be the Proposed Rule Change not propose to change the applicable available for Web site viewing and The Exchange proposes to amend the monthly recurring connectivity fee. The printing in the Commission’s Public NYSE American Equities Price List Exchange proposes the following Reference Room, 100 F Street NE., (‘‘Price List’’) and the NYSE American changes: Washington, DC 20549 on official Options Fee Schedule (‘‘Fee Schedule’’) • In the third sentence under business days between the hours of relating to co-location services to reflect ‘‘Connectivity to Third Party Data 10:00 a.m. and 3:00 p.m. Copies of the the name change of a third party data Feeds,’’ the reference to ‘‘NYSE Global filing also will be available for feed. The Exchange proposes to Index’’ would be changed to ‘‘ICE Data inspection and copying at the principal implement the proposed change on Global Index.’’ • office of the Exchange. All comments November 1, 2017. The proposed In the table under ‘‘Connectivity to received will be posted without change. change is available on the Exchange’s Third Party Data Feeds,’’ the line listing Persons submitting comments are Web site at www.nyse.com, at the ‘‘NYSE Global Index’’ and the related cautioned that we do not redact or edit principal office of the Exchange, and at $100 monthly recurring connectivity fee personal identifying information from the Commission’s Public Reference would be deleted, and a new line added, comment submissions. You should Room. as follows (additions italicized): submit only information that you wish to make available publicly. All II. Self-Regulatory Organization’s submissions should refer to File Statement of the Purpose of, and Number SR–NYSEARCA–2017–124 and Statutory Basis for, the Proposed Rule Monthly recurring Change connectivity fee should be submitted on or before Third Party Data Feed per Third Party December 4, 2017. In its filing with the Commission, the Data Feed For the Commission, by the Division of self-regulatory organization included Trading and Markets, pursuant to delegated statements concerning the purpose of, Global OTC ...... $100 authority.16 ICE Data Global Index ... 100 and basis for, the proposed rule change ICE Data Services Con- Eduardo A. Aleman, and discussed any comments it received solidated Feed ≤ 100 Assistant Secretary. on the proposed rule change. The text Mb ...... 200 [FR Doc. 2017–24442 Filed 11–9–17; 8:45 am] of those statements may be examined at BILLING CODE 8011–01–P the places specified in Item IV below. General The Exchange has prepared summaries, set forth in sections A, B, and C below, As is the case with all Exchange co- SECURITIES AND EXCHANGE of the most significant parts of such location arrangements, (i) neither a User COMMISSION statements. nor any of the User’s customers would be permitted to submit orders directly to [Release No. 34–82021; File No. SR– A. Self-Regulatory Organization’s the Exchange unless such User or NYSEAMER–2017–28] Statement of the Purpose of, and the customer is a member organization, a Statutory Basis for, the Proposed Rule Sponsored Participant or an agent Self-Regulatory Organizations; NYSE Change thereof (e.g., a service bureau providing American LLC; Notice of Filing and Immediate Effectiveness of Proposed 1. Purpose from the Exchange. See Securities Exchange Act Change To Amend the NYSE American The Exchange proposes to amend the Release No. 76009 (September 29, 2015), 80 FR Equities Price List and the NYSE Price List and Fee Schedule relating to 60213 (October 5, 2015) (SR–NYSEMKT–2015–67). American Options Fee Schedule co-location 4 services to reflect the name As specified in the Price List and Fee Schedule, a Relating to Co-Location Services To User that incurs co-location fees for a particular co- change of a third party data feed. The location service pursuant thereto would not be Reflect the Name Change of a Third Exchange proposes to implement the subject to co-location fees for the same co-location Party Data Feed proposed change on November 1, 2017. service charged by the Exchange’s affiliates New York Stock Exchange LLC (‘‘NYSE LLC’’) and NYSE November 6, 2017. The co-location services that the Arca, Inc. (‘‘NYSE Arca’’ and, together with NYSE 5 Pursuant to Section 19(b)(1) 1 of the Exchange offers Users include LLC, the ‘‘Affiliate SROs’’). See Securities Exchange Securities Exchange Act of 1934 (the Act Release No. 70176 (August 13, 2013), 78 FR 4 50471 (August 19, 2013) (SR–NYSEMKT–2013–67). 2 3 The Exchange initially filed rule changes ‘‘Act’’) and Rule 19b–4 thereunder, relating to its co-location services with the 6 See Securities Exchange Act Release No. 80309 notice is hereby given that, on October Commission in 2010. See Securities Exchange Act (March 24, 2017), 82 FR 15725 (March 30, 2017) 25, 2017, NYSE American LLC Release No. 62961 (September 21, 2010), 75 FR (SR–NYSEMKT–2016–63). (‘‘Exchange’’ or ‘‘NYSE American’’) filed 59299 (September 27, 2010) (SR–NYSEAmex–2010– 7 The NYSE Global Index feed includes index and 80). The Exchange operates a data center in exchange traded product valuations data, with data Mahwah, New Jersey (the ‘‘data center’’) from drawn from the Exchange, the Affiliate SROS, and 16 17 CFR 200.30–3(a)(12). which it provides co-location services to Users. third party exchanges. Because it includes third 1 15 U.S.C. 78s(b)(1). 5 For purposes of the Exchange’s co-location party data, the NYSE Global Index feed is 2 15 U.S.C. 78a. services, a ‘‘User’’ means any market participant considered a Third Party Data Feed. See id., at 3 17 CFR 240.19b–4. that requests to receive co-location services directly 15733.
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order entry services); (ii) use of the co- For the reasons above, the proposed change is consistent with the Act. location services proposed herein would changes would not unfairly discriminate Comments may be submitted by any of be completely voluntary and available between or among market participants the following methods: to all Users on a non-discriminatory that are otherwise capable of satisfying Electronic Comments basis; 8 and (iii) a User would only incur any applicable co-location fees, one charge for the particular co-location requirements, terms and conditions • Use the Commission’s Internet service described herein, regardless of established from time to time by the comment form (http://www.sec.gov/ whether the User connects only to the Exchange. rules/sro.shtml); or • Exchange or to the Exchange and one or For these reasons, the Exchange Send an email to rule-comments@ both the Affiliate SROs.9 believes that the proposal is consistent sec.gov. Please include File Number SR– The proposed change is not otherwise with the Act. NYSEAMER–2017–28 on the subject intended to address any other issues line. relating to co-location services and/or B. Self-Regulatory Organization’s Paper Comments related fees, and the Exchange is not Statement on Burden on Competition • aware of any problems that Users would In accordance with Section 6(b)(8) of Send paper comments in triplicate have in complying with the proposed the Act,12 the Exchange believes that the to Secretary, Securities and Exchange change. proposed rule change will not impose Commission, 100 F Street NE., Washington, DC 20549–1090. 2. Statutory Basis any burden on competition that is not necessary or appropriate in furtherance All submissions should refer to File The Exchange believes that the of the purposes of the Act because it is Number SR–NYSEAMER–2017–28. This proposed rule change is consistent with solely intended to reflect the name file number should be included on the 10 Section 6(b) of the Act, in general, and change of ‘‘NYSE Global Index’’ to ‘‘ICE subject line if email is used. To help the furthers the objectives of Sections Data Global Index.’’ No other change is Commission process and review your 11 6(b)(5) of the Act, in particular, proposed. comments more efficiently, please use because it is designed to prevent only one method. The Commission will fraudulent and manipulative acts and C. Self-Regulatory Organization’s post all comments on the Commission’s practices, to promote just and equitable Statement on Comments on the Internet Web site (http://www.sec.gov/ principles of trade, to foster cooperation Proposed Rule Change Received From rules/sro.shtml). Copies of the and coordination with persons engaged Members, Participants, or Others submission, all subsequent in regulating, clearing, settling, No written comments were solicited amendments, all written statements processing information with respect to, or received with respect to the proposed with respect to the proposed rule and facilitating transactions in rule change. change that are filed with the securities, to remove impediments to, Commission, and all written and perfect the mechanisms of, a free III. Date of Effectiveness of the communications relating to the and open market and a national market Proposed Rule Change and Timing for proposed rule change between the system and, in general, to protect Commission Action Commission and any person, other than investors and the public interest. The foregoing rule change is effective those that may be withheld from the The non-substantive change proposed upon filing pursuant to Section public in accordance with the is intended solely to reflect the name 19(b)(3)(A) 13 of the Act and provisions of 5 U.S.C. 552, will be change of ‘‘NYSE Global Index’’ to ‘‘ICE subparagraph (f)(2) of Rule 19b–4 14 available for Web site viewing and Data Global Index.’’ The proposed rule thereunder, because it establishes a due, printing in the Commission’s Public change, therefore would remove fee, or other charge imposed by the Reference Room, 100 F Street NE., impediments to, and perfect the Exchange. Washington, DC 20549 on official mechanisms of, a free and open market At any time within 60 days of the business days between the hours of and a national market system and, in filing of such proposed rule change, the 10:00 a.m. and 3:00 p.m. Copies of the general, protect investors and the public Commission summarily may filing also will be available for interest because it would update the temporarily suspend such rule change if inspection and copying at the principal Price List and Fee Schedule to reflect it appears to the Commission that such office of the Exchange. All comments the name change, increasing the clarity action is necessary or appropriate in the received will be posted without change. and transparency of the Exchange’s public interest, for the protection of rules. Persons submitting comments are investors, or otherwise in furtherance of cautioned that we do not redact or edit the purposes of the Act. If the 8 As is currently the case, Users that receive co- personal identifying information from location services from the Exchange will not receive Commission takes such action, the comment submissions. You should any means of access to the Exchange’s trading and Commission shall institute proceedings submit only information that you wish execution systems that is separate from, or superior under Section 19(b)(2)(B) 15 of the Act to to make available publicly. All to, that of other Users. In this regard, all orders sent to the Exchange enter the Exchange’s trading and determine whether the proposed rule submissions should refer to File execution systems through the same order gateway, change should be approved or Number SR–NYSEAMER–2017–28 and regardless of whether the sender is co-located in the disapproved. should be submitted on or before data center or not. In addition, co-located Users do December 4, 2017. not receive any market data or data service product IV. Solicitation of Comments that is not available to all Users, although Users that For the Commission, by the Division of receive co-location services normally would expect Interested persons are invited to Trading and Markets, pursuant to delegated reduced latencies in sending orders to, and submit written data, views, and authority.16 receiving market data from, the Exchange. arguments concerning the foregoing, Eduardo A. Aleman, 9 See 78 FR 50471, supra note 5, at 50471. The including whether the proposed rule Affiliate SROs have also submitted substantially the Assistant Secretary. same proposed rule change to propose the changes [FR Doc. 2017–24441 Filed 11–9–17; 8:45 am] described herein. See SR–NYSE–2017–55 and SR– 12 15 U.S.C. 78f(b)(8). NYSEArca–2017–124. 13 15 U.S.C. 78s(b)(3)(A). BILLING CODE 8011–01–P 10 15 U.S.C. 78f(b). 14 17 CFR 240.19b–4(f)(2). 11 15 U.S.C. 78f(b)(5). 15 15 U.S.C. 78s(b)(2)(B). 16 17 CFR 200.30–3(a)(12).
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SECURITIES AND EXCHANGE examination staff uses these records to transactions would be 3 hours annually COMMISSION evaluate for compliance with the rule. for each respondent, (2 hours spent by While most funds do not commonly compliance attorneys and 1 hour spent Submission for OMB Review; engage in transactions covered by rule by the board of directors) 7 or 2,505 total Comment Request 17a–7, the Commission staff estimates hours each year.8 that nearly all funds have adopted Based on these estimates, the staff Upon Written Request, Copies Available procedures for complying with the estimates the combined total annual 2 From: Securities and Exchange rule. Of the approximately 3,243 burden hours associated with rule 17a– Commission Office of FOIA Services currently active funds, the staff 7 is 2,893 hours.9 The staff also 100 F Street NE., Washington, DC estimates that virtually all have already estimates that there are approximately 20549–2736 adopted procedures for compliance with 835 respondents and 6,680 total Extension: rule 17a–7. This is a one-time burden, responses.10 and the staff therefore does not estimate Rule 17a–7, SEC File No. 270–238, OMB The estimates of burden hours are Control No. 3235–0214 an ongoing burden related to the policies and procedures requirement of made solely for the purposes of the Paperwork Reduction Act, and are not Notice is hereby given that, pursuant the rule for funds.3 The staff estimates derived from a comprehensive or even to the Paperwork Reduction Act of 1995 that there are approximately 97 new a representative survey or study of the (44 U.S.C. 3501–3520), the Securities funds that register each year, and that costs of Commission rules. The and Exchange Commission each of these funds adopts the relevant collection of information required by (‘‘Commission’’) has submitted to the policies and procedures. The staff rule 17a–7 is necessary to obtain the Office of Management and Budget a estimates that it takes approximately 4 benefits of the rule. Responses will not request for extension of the previously hours to develop and adopt these be kept confidential. An agency may not approved collection of information policies and procedures. Therefore, the conduct or sponsor, and a person is not described below. total annual burden related to required to respond to, a collection of Rule 17a–7 (17 CFR 270.17a–7) (the developing and adopting these policies and procedures would be approximately information unless it displays a ‘‘rule’’) under the Investment Company currently valid control number. 388 hours.4 Act of 1940 (15 U.S.C. 80a–1 et seq.) The public may view the background (the ‘‘Act’’) is entitled ‘‘Exemption of Of the 3,243 existing funds, the staff assumes that approximately 25%, (or documentation for this information certain purchase or sale transactions collection at the following Web site, between an investment company and 811) enter into transactions affected by rule 17a–7 each year (either by the fund www.reginfo.gov. Comments should be certain affiliated persons thereof.’’ It directed to: (i) Desk Officer for the provides an exemption from section directly or through one of the fund’s series), and that the same percentage Securities and Exchange Commission, 17(a) of the Act for purchases and sales Office of Information and Regulatory of securities between registered (25%, or 24 funds) of the estimated 97 funds that newly register each year will Affairs, Office of Management and investment companies (‘‘funds’’), that Budget, Room 10102, New Executive are affiliated persons (‘‘first-tier also enter into these transactions, for a total of 835 5 companies that are affected Office Building, Washington, DC 20503, affiliates’’) or affiliated persons of or by sending an email to: Shagufta_ affiliated persons (‘‘second-tier by the recordkeeping requirements of rule 17a–7. These funds must keep [email protected]; and (ii) Pamela affiliates’’), or between a fund and a Dyson, Director/Chief Information first- or second-tier affiliate other than records of each of these transactions, and the board of directors must Officer, Securities and Exchange another fund, when the affiliation arises Commission, c/o Remi Pavlik-Simon, solely because of a common investment quarterly determine that all relevant transactions were made in compliance 100 F Street NE., Washington, DC 20549 adviser, director, or officer. Rule 17a–7 or send an email to: PRA_Mailbox@ requires funds to keep various records with the company’s policies and procedures. The rule generally imposes sec.gov. Comments must be submitted to in connection with purchase or sale OMB within 30 days of this notice. transactions effected in reliance on the a minimal burden of collecting and storing records already generated for Dated: November 7, 2017. rule. The rule requires the fund’s board 6 of directors to establish procedures other purposes. The staff estimates that Eduardo A. Aleman, reasonably designed to ensure that the the burden related to making these Assistant Secretary. records and for the board to review all rule’s conditions have been satisfied. [FR Doc. 2017–24485 Filed 11–9–17; 8:45 am] The board is also required to determine, BILLING CODE 8011–01–P 2 Unless stated otherwise, these estimates are at least on a quarterly basis, that all based on conversations with the examination and affiliated transactions effected during inspections staff of the Commission and fund 7 The staff estimates that funds that rely on rule the preceding quarter in reliance on the representatives. 17a–7 annually enter into an average of 8 rule 17a– rule were made in compliance with 3 Based on our reviews and conversations with 7 transactions each year. The staff estimates that the fund representatives, we understand that funds compliance attorneys of the companies spend these established procedures. If a fund rarely, if ever, need to make changes to these approximately 15 minutes per transaction on this enters into a purchase or sale policies and procedures once adopted, and recordkeeping, and the board of directors spends a transaction with an affiliated person, the therefore we do not estimate a paperwork burden total of 1 hour annually in determining that all rule requires the fund to compile and for such updates. transactions made that year were done in 4 This estimate is based on the following compliance with the company’s policies and maintain written records of the × procedures. 1 calculations: (4 hours 97 new funds = 388 hours). transaction. The Commission’s 5 This estimate is based on the following 8 This estimate is based on the following calculation: (811 + 24 = 835). calculation: (3 hours × 835 companies = 2,505 1 The written records are required to set forth a 6 Commission staff believes that rule 17a–7 does hours). description of the security purchased or sold, the not impose any costs associated with record 9 This estimate is based on the following identity of the person on the other side of the preservation in addition to the costs that funds calculation: (388 hours + 2,505 hours = 2,893 total transaction, and the information or materials upon already incur to comply with the record hours). which the board of directors’ determination that the preservation requirements of rule 31a–2 under the 10 This estimate is based on the following transaction was in compliance with the procedures Act. Rule 31a–2 requires companies to preserve calculations: 835 funds that engage in rule 17a–7 was made. certain records for specified periods of time. transactions × 8 transactions per year = 6,680.
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SMALL BUSINESS ADMINISTRATION (Catalog of Federal Domestic Assistance Diaz, Juncos, Lajas, Lares, Las Number 59008) Marias, Las Piedras, Loiza, [Disaster Declaration #15370; Oregon Linda E. McMahon, Luquillo, Manati, Maricao, Disaster Number OR–00088 Declaration of Administrator. Maunabo, Mayaguez, Moca, Economic Injury] Morovis, Naguabo, Naranjito, [FR Doc. 2017–24475 Filed 11–9–17; 8:45 am] Orocovis, Patillas, Penuelas, Ponce, Administrative Declaration of an BILLING CODE 8025–01–P Quebradillas, Rincon, Rio Grande, Economic Injury Disaster for the State Sabana Grande, Salinas, San of Oregon SMALL BUSINESS ADMINISTRATION German, San Juan, San Lorenzo, San Sebastian, Santa Isabel, Toa AGENCY: U.S. Small Business [Disaster Declaration #15374 and #15375; Alta, Toa Baja, Trujillo Alto, Administration. PUERTO RICO Disaster Number PR–00032] Utuado, Vega Alta, Vega Baja, Vieques, Villalba, Yabucoa, Yauco ACTION: Notice. Presidential Declaration of a Major Disaster for Public Assistance Only for The Interest Rates are: SUMMARY: This is a notice of an the Commonwealth of Puerto Rico Economic Injury Disaster Loan (EIDL) Percent declaration for the State of Oregon, AGENCY: U.S. Small Business dated 10/31/2017. Administration. For Physical Damage: Non-Profit Organizations with Incident: Eagle Creek Fire. ACTION: Notice. Credit Available Elsewhere ... 2.500 Incident Period: 09/02/2017 and Non-Profit Organizations with- SUMMARY: This is a Notice of the continuing. out Credit Available Else- Presidential declaration of a major where ...... 2.500 DATES: Issued on 10/31/2017. disaster for Public Assistance Only for For Economic Injury: the Commonwealth of Puerto Rico Non-Profit Organizations with- Economic Injury (EIDL) Loan out Credit Available Else- Application Deadline Date: 07/31/2018. (FEMA–4339–DR), dated 11/02/2017. Incident: Hurricane Maria. where ...... 2.500 ADDRESSES: Submit completed loan Incident Period: 09/17/2017 and applications to: U.S. Small Business continuing. The number assigned to this disaster Administration, Processing and for physical damage is 153748 and for DATES: Issued on 11/02/2017. Disbursement Center, 14925 Kingsport economic injury is 153750. Physical Loan Application Deadline Road, Fort Worth, TX 76155. Date: 01/02/2018. (Catalog of Federal Domestic Assistance Number 59008) FOR FURTHER INFORMATION CONTACT: A. Economic Injury (EIDL) Loan Escobar, Office of Disaster Assistance, Application Deadline Date: 08/02/2018. James E. Rivera, U.S. Small Business Administration, ADDRESSES: Submit completed loan Associate Administrator for Disaster 409 3rd Street SW., Suite 6050, applications to: U.S. Small Business Assistance. Washington, DC 20416, (202) 205–6734. Administration, Processing and [FR Doc. 2017–24476 Filed 11–9–17; 8:45 am] SUPPLEMENTARY INFORMATION: Notice is Disbursement Center, 14925 Kingsport BILLING CODE 8025–01–P hereby given that as a result of the Road, Fort Worth, TX 76155. Administrator’s EIDL declaration, FOR FURTHER INFORMATION CONTACT: A. applications for economic injury Escobar, Office of Disaster Assistance, SMALL BUSINESS ADMINISTRATION disaster loans may be filed at the U.S. Small Business Administration, [Disaster Declaration #15322 and #15323; address listed above or other locally 409 3rd Street SW., Suite 6050, Puerto Rico Disaster Number PR–00031] announced locations. Washington, DC 20416, (202) 205–6734. Presidential Declaration Amendment of The following areas have been SUPPLEMENTARY INFORMATION: Notice is a Major Disaster for the determined to be adversely affected by hereby given that as a result of the Commonwealth of Puerto Rico the disaster: President’s major disaster declaration on Primary Counties: Hood River, Wasco 11/02/2017, Private Non-Profit AGENCY: U.S. Small Business organizations that provide essential Administration. Contiguous Counties: services of a governmental nature may ACTION: Amendment 2. Oregon: Clackamas, Gilliam, Jefferson, file disaster loan applications at the Marion, Multnomah, Sherman, address listed above or other locally SUMMARY: This is an amendment of the Wheeler announced locations. Presidential declaration of a major Washington: Klickitat, Skamania The following areas have been disaster for the Commonwealth of determined to be adversely affected by Puerto Rico (FEMA–4339–DR), dated The Interest Rates are: the disaster: 09/20/2017. Incident: Hurricane Maria. Incident Period: 09/17/2017 and Percent Primary Municipalities: Adjuntas, Aguada, Aguadilla, Aguas Buenas, continuing. Businesses and Small Agricultural Aibonito, Anasco, Arecibo, Arroyo, DATES: Issued on 11/06/2017. Cooperatives without Credit Barceloneta, Barranquitas, Physical Loan Application Deadline Available Elsewhere ...... 3.305 Bayamon, Cabo Rojo, Caguas, Date: 03/20/2018. Non-Profit Organizations without Camuy, Canovanas, Carolina, Economic Injury (EIDL) Loan Credit Available Elsewhere ...... 2.500 Catano, Cayey, Ceiba, Ciales, Cidra, Application Deadline Date: 06/20/2018. Coamo, Comerio, Corozal, Culebra, ADDRESSES: Submit completed loan The number assigned to this disaster Dorado, Fajardo, Florida, Guanica, applications to: U.S. Small Business for economic injury is 153700. Guayama, Guayanilla, Guaynabo, Administration, Processing and The States which received an EIDL Gurabo, Hatillo, Hormigueros, Disbursement Center, 14925 Kingsport Declaration # are Oregon, Washington. Humacao, Isabela, Jayuya, Juana Road, Fort Worth, TX 76155.
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FOR FURTHER INFORMATION CONTACT: A. accommodations should let the contact ACTION: Notice of Appointments to the Escobar, Office of Disaster Assistance, below know at least a week in advance. Fiscal Service Performance Review U.S. Small Business Administration, FOR FURTHER INFORMATION CONTACT: Board. 409 3rd Street SW., Suite 6050, Barbie Perdue, 865–632–6113, Washington, DC 20416, (202) 205–6734. [email protected]. SUMMARY: This notice announces the SUPPLEMENTARY INFORMATION: The notice SUPPLEMENTARY INFORMATION: appointment of the members of the of the President’s major disaster The meeting agenda includes the Fiscal Service Performance Review declaration for the Commonwealth of following: Board (PRB) for the Bureau of the Fiscal Puerto Rico, dated 09/20/2017, is hereby 1. Introductions Service (Fiscal Service). The PRB amended to extend the deadline for 2. An overview of TVA’s Mission and reviews the performance appraisals of filing applications for physical damages Scope career senior executives who are below as a result of this disaster to 03/20/2018. 3. Presentations regarding TVA’s Rates the level of Assistant Commissioner/ and Finances, TVA’s Long Range All other information in the original Executive Director and who are not Energy Planning efforts and Energy declaration remains unchanged. assigned to the Office of the Efficiency projects for Low Income (Catalog of Federal Domestic Assistance Commissioner in the Fiscal Service. The Number 59008) Residents 4. Public Comments PRB makes recommendations regarding James E. Rivera, 5. Council Discussion proposed performance appraisals, Associate Administrator for Disaster The RERC will hear opinions and ratings, bonuses, pay adjustments, and Assistance. views of citizens by providing a public other appropriate personnel actions. [FR Doc. 2017–24478 Filed 11–9–17; 8:45 am] comment session starting at 1:15 p.m. DATES: Applicable on November 13, BILLING CODE 8025–01–P EST, lasting up to one hour, on 2017. Wednesday, November 29, 2017. Persons wishing to speak are requested FOR FURTHER INFORMATION CONTACT: to register at the door between 11:00 Randy L. Thornton, Chief Human TENNESSEE VALLEY AUTHORITY a.m. and 1:00 p.m., EST, on Wednesday, Capital Officer, Bureau of the Fiscal Meeting of the Regional Energy November 29, 2017, and will be called Service, (202) 874–5147. on during the public comment period. Resource Council TVA will set time limits for providing SUPPLEMENTARY INFORMATION: This AGENCY: Tennessee Valley Authority oral comments, once registered. Notice announces the appointment of (TVA). Handout materials should be limited to the following primary and alternate ACTION: Notice of meeting. one printed page. Written comments are members to the Fiscal Service PRB: also invited and may be mailed to the Primary Members: SUMMARY: The TVA Regional Energy Regional Energy Resource Council, Stephen L. Manning, Deputy Resource Council (RERC) will hold a Tennessee Valley Authority, 400 West meeting on Wednesday, November 29, Summit Hill Drive, WT–9 D, Knoxville, Commissioner, Finance & 2017, to consider various matters related Tennessee 37902. Administration, Fiscal Service to energy resources in the Tennessee Dated: November 6, 2017. Dara N. Seaman, Assistant Valley. Joseph J. Hoagland, Commissioner, Wholesale The RERC was established to advise Vice President, Enterprise Relations and Securities Services, Fiscal Service TVA on its energy resource activities Innovation, Tennessee Valley Authority. Douglas Anderson, Assistant and the priority to be placed among [FR Doc. 2017–24499 Filed 11–9–17; 8:45 am] Commissioner, Shared Services, competing objectives and values. Notice BILLING CODE 8120–08–P Fiscal Service of this meeting is given under the Federal Advisory Committee Act Alternate Member: (FACA). DEPARTMENT OF THE TREASURY John B. Hill, Assistant Commissioner, DATES: The public meeting will be held Financial Innovation & on Wednesday, November 29, 2017, Fiscal Service Transformation, Fiscal Service from 8:30 a.m. to 3:30 p.m., EST. Authority: 5 U.S.C. Section 4314(c)(4) Bureau of the Fiscal Service; Senior ADDRESSES: The meeting will be held at Executive Service; Fiscal Service Sheryl R. Morrow, Hilton Knoxville, 501 West Church Performance Review Board Avenue, Knoxville, Tennessee 37902, Commissioner, Bureau of the Fiscal Service. and will be open to the public. Anyone AGENCY: Bureau of the Fiscal Service, [FR Doc. 2017–24513 Filed 11–9–17; 8:45 am] needing special access or Treasury. BILLING CODE 4810–AS–P
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Part II
Department of Health and Human Services
Centers for Medicare & Medicaid Services 42 CFR Parts 414, 416, and 419 Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Rule
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DEPARTMENT OF HEALTH AND 2. By regular mail. You may mail Advisory Panel on Hospital Outpatient HUMAN SERVICES written comments to the following Payment (HOP Panel), contact the HOP Panel address ONLY: mailbox at [email protected]. Ambulatory Surgical Center (ASC) Centers for Medicare & Medicaid Centers for Medicare & Medicaid Services Payment System, contact Elisabeth Daniel via Services, Department of Health and email [email protected] or at Human Services, Attention: CMS–1678– 410–786–0237. 42 CFR Parts 414, 416, and 419 FC, P.O. Box 8013, Baltimore, MD Ambulatory Surgical Center Quality [CMS–1678–FC] 21244–1850. Reporting (ASCQR) Program Administration, Please allow sufficient time for mailed Validation, and Reconsideration Issues, RIN 0938–AT03 comments to be received before the contact Anita Bhatia via email Anita.Bhatia@ cms.hhs.gov or at 410–786–7236. Medicare Program: Hospital Outpatient close of the comment period. Ambulatory Surgical Center Quality Prospective Payment and Ambulatory 3. By express or overnight mail. You Reporting (ASCQR) Program Measures, Surgical Center Payment Systems and may send written comments via express contact Vinitha Meyyur via email Quality Reporting Programs or overnight mail to the following [email protected] or at 410–786– address ONLY: 8819. AGENCY: Centers for Medicare & Centers for Medicare & Medicaid Blood and Blood Products, contact Josh Medicaid Services (CMS), HHS. Services, Department of Health and McFeeters via email Joshua.McFeeters@ cms.hhs.gov at 410–786–9732. ACTION: Final rule with comment period. Human Services, Attention: CMS–1678– Cancer Hospital Payments, contact Scott FC, Mail Stop C4–26–05, 7500 Security Talaga via email [email protected] SUMMARY: This final rule with comment Boulevard, Baltimore, MD 21244–1850. or at 410–786–4142. period revises the Medicare hospital 4. By hand or courier. If you prefer, Care Management Services, contact Scott outpatient prospective payment system you may deliver (by hand or courier) Talaga via email [email protected] (OPPS) and the Medicare ambulatory your written comments before the close or at 410–786–4142. surgical center (ASC) payment system of the comment period to either of the CPT Codes, contact Marjorie Baldo via for CY 2018 to implement changes following addresses: email [email protected] or at 410– arising from our continuing experience 786–4617. a. For delivery in Washington, DC— with these systems. In this final rule CMS Web Posting of the OPPS and ASC Centers for Medicare & Medicaid with comment period, we describe the Payment Files, contact Chuck Braver via Services, Department of Health and changes to the amounts and factors used email [email protected] or at 410– Human Services, Room 445–G, Hubert 786–6719. to determine the payment rates for H. Humphrey Building, 200 Composite APCs (Low Dose Brachytherapy Medicare services paid under the OPPS Independence Avenue SW., and Multiple Imaging), contact Twi Jackson and those paid under the ASC payment Washington, DC 20201. via email [email protected] or at system. In addition, this final rule with 410–786–1159. comment period updates and refines the (Because access to the interior of the Comprehensive APCs (C–APCs), contact requirements for the Hospital Hubert H. Humphrey Building is not Lela Strong via email Lela.Strong@ Outpatient Quality Reporting (OQR) readily available to persons without cms.hhs.gov or at 410–786–3213. Program and the ASC Quality Reporting Federal Government identification, Hospital Outpatient Quality Reporting (ASCQR) Program. commenters are encouraged to leave (OQR) Program Administration, Validation, their comments in the CMS drop slots and Reconsideration Issues, contact Anita DATES: located in the main lobby of the Bhatia via email [email protected] Effective date: This final rule with building. A stamp-in clock is available or at 410–786–7236. comment period is effective on January for persons wishing to retain a proof of Hospital Outpatient Quality Reporting 1, 2018, unless otherwise noted. (OQR) Program Measures, contact Vinitha filing by stamping in and retaining an Comment period: To be assured Meyyur via email Vinitha.Meyyur@ extra copy of the comments being filed.) consideration, comments on the cms.hhs.gov or at 410–786–8819. payment classifications assigned to b. For delivery in Baltimore, MD— Hospital Outpatient Visits (Emergency HCPCS codes identified in Addenda B, Centers for Medicare & Medicaid Department Visits and Critical Care Visits), contact Twi Jackson via email Twi.Jackson@ AA, and BB with the comment indicator Services, Department of Health and Human Services, 7500 Security cms.hhs.gov or at 410–786–1159. ‘‘NI’’ and on other areas specified Inpatient Only (IPO) Procedures List, throughout this final rule with comment Boulevard, Baltimore, MD 21244–1850. If you intend to deliver your contact Lela Strong via email Lela.Strong@ period must be received at one of the cms.hhs.gov or at 410–786–3213. addresses provided in the ADDRESSES comments to the Baltimore address, New Technology Intraocular Lenses section no later than 5 p.m. EST on please call the telephone number (410) (NTIOLs), contact Scott Talaga via email December 31, 2017. 786–7195 in advance to schedule your [email protected] or at 410–786– arrival with one of our staff members. 4142. ADDRESSES: In commenting, please refer No Cost/Full Credit and Partial Credit to file code CMS–1678–FC when Comments mailed to the addresses indicated as appropriate for hand or Devices, contact Twi Jackson via email commenting on the issues in this [email protected] or at 410–786– proposed rule. Because of staff and courier delivery may be delayed and received after the comment period. 1159. resource limitations, we cannot accept OPPS Brachytherapy, contact Scott Talaga comments by facsimile (FAX) For information on viewing public via email [email protected] or at transmission. comments, we refer readers to the 410–786–4142. You may submit comments in one of beginning of the SUPPLEMENTARY OPPS Data (APC Weights, Conversion four ways (no duplicates, please): INFORMATION section. Factor, Copayments, Cost-to-Charge Ratios (CCRs), Data Claims, Geometric Mean 1. Electronically. You may (and we FOR FURTHER INFORMATION CONTACT: (We Calculation, Outlier Payments, and Wage encourage you to) submit electronic note that public comments must be Index), contact Erick Chuang via email comments on this regulation to http:// submitted through one of the four [email protected] or at 410–786– www.regulations.gov. Follow the channels outlined in the ADDRESSES 1816 or Elisabeth Daniel via email instructions under the ‘‘submit a section above. Comments may not be [email protected] or at 410– comment’’ tab. submitted via email.) 786–0237.
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OPPS Drugs, Radiopharmaceuticals, public comments, phone 1–800–743– CAUTI Catheter-associated urinary tract Biologicals, and Biosimilar Products, contact 3951. infection Elisabeth Daniel via email CBSA Core-Based Statistical Area [email protected] or at 410– Electronic Access CCM Chronic care management 786–0237. CCN CMS Certification Number OPPS New Technology Procedures/ This Federal Register document is CCR Cost-to-charge ratio Services, contact the New Technology APC also available from the Federal Register CDC Centers for Disease Control and email at NewTechAPCapplications@ online database through Federal Digital Prevention cms.hhs.gov. System (FDsys), a service of the U.S. CED Coverage with Evidence Development OPPS Exceptions to the 2 Times Rule, Government Printing Office. This CERT Comprehensive Error Rate Testing contact Marjorie Baldo via email database can be accessed via the CFR Code of Federal Regulations CI Comment indicator [email protected] or at 410–786– Internet at https://www.gpo.gov/fdsys/. 4617. CLABSI Central Line [Catheter] Associated OPPS Packaged Items/Services, contact Addenda Available Only Through the Blood Stream Infection Elisabeth Daniel via email Elisabeth. Internet on the CMS Web Site CLFS Clinical Laboratory Fee Schedule [email protected] or at 410–786–0237. CMHC Community mental health center OPPS Pass-Through Devices, contact the In the past, a majority of the Addenda CMS Centers for Medicare & Medicaid Device Pass-Through email at Device referred to in our OPPS/ASC proposed Services [email protected]. and final rules were published in the CoP Condition of participation OPPS Status Indicators (SI) and Comment CPI–U Consumer Price Index for All Urban Federal Register as part of the annual Consumers Indicators (CI), contact Marina Kushnirova rulemakings. However, beginning with CPT Current Procedural Terminology via email [email protected] or the CY 2012 OPPS/ASC proposed rule, (copyrighted by the American Medical at 410–786–2682. Association) Partial Hospitalization Program (PHP) and all of the Addenda no longer appear in the Federal Register as part of the CR Change request Community Mental Health Center (CMHC) CRC Colorectal cancer Issues, contact the PHP Payment Policy annual OPPS/ASC proposed and final rules to decrease administrative burden CSAC Consensus Standards Approval Mailbox at [email protected]. Committee Revisions to the Laboratory Date of Service and reduce costs associated with CT Computed tomography Policy, contact Craig Dobyski via email publishing lengthy tables. Instead, these CV Coefficient of variation [email protected] or at 410–786– Addenda are published and available CY Calendar year 4584 or Rasheeda Johnson via email only on the CMS Web site. The DFO Designated Federal Official [email protected] or at 410– Addenda relating to the OPPS are DME Durable medical equipment 786–3434 or Marjorie Baldo (for OPPS) via DMEPOS Durable Medical Equipment, email [email protected] or at 410– available at: https://www.cms.gov/ Medicare/Medicare-Fee-for-Service- Prosthetic, Orthotics, and Supplies 786–4617. DOS Date of service Rural Hospital Payments, contact Josh Payment/HospitalOutpatientPPS/ DRA Deficit Reduction Act of 2005, Public McFeeters via email Joshua.McFeeters@ index.html. The Addenda relating to the Law 109–171 cms.hhs.gov or at 410–786–9732. ASC payment system are available at: DSH Disproportionate share hospital Skin Substitutes, contact Josh McFeeters https://www.cms.gov/Medicare/ EACH Essential access community hospital via email [email protected] or Medicare-Fee-for-Service-Payment/ EAM Extended assessment and at 410–786–9732. HospitalOutpatientPPS/index.html. management All Other Issues Related to Hospital ECD Expanded criteria donor Alphabetical List of Acronyms Outpatient and Ambulatory Surgical EBRT External beam radiotherapy Appearing in This Federal Register ECG Electrocardiogram Center Payments Not Previously Document ED Emergency department Identified, contact Lela Strong via email EDTC Emergency department transfer [email protected] or at 410–786– AHA American Hospital Association communication 3213. AMA American Medical Association EHR Electronic health record AMI Acute myocardial infarction SUPPLEMENTARY INFORMATION: E/M Evaluation and management Inspection of Public Comments: All APC Ambulatory Payment Classification ESRD End-stage renal disease API Application programming interface ESRDQIP End-Stage Renal Disease Quality comments received before the close of APU Annual payment update the comment period are available for Improvement Program ASC Ambulatory surgical center FACA Federal Advisory Committee Act, viewing by the public, including any ASCQR Ambulatory Surgical Center Public Law 92–463 personally identifiable or confidential Quality Reporting FDA Food and Drug Administration business information that is included in ASP Average sales price FFS [Medicare] Fee-for-service a comment. We post all comments AUC Appropriate use criteria FY Fiscal year received before the close of the AWP Average wholesale price GAO Government Accountability Office comment period on the following Web BBA Balanced Budget Act of 1997, Public GI Gastrointestinal site as soon as possible after they have Law 105–33 GME Graduate medical education BBRA Medicare, Medicaid, and SCHIP been received: http:// HAI Healthcare-associated infection [State Children’s Health Insurance HCAHPS Hospital Consumer Assessment of www.regulations.gov/. Follow the search Program] Balanced Budget Refinement Act Healthcare Providers and Systems instructions on that Web site to view of 1999, Public Law 106–113 HCERA Health Care and Education public comments. BIPA Medicare, Medicaid, and SCHIP Reconciliation Act of 2010, Public Law Comments received timely will also Benefits Improvement and Protection Act 111–152 be available for public inspection, of 2000, Public Law 106–554 HCP Health care personnel generally beginning approximately 3 BLS Bureau of Labor Statistics HCPCS Healthcare Common Procedure weeks after publication of the rule, at CAH Critical access hospital Coding System the headquarters of the Centers for CAHPS Consumer Assessment of HCRIS Healthcare Cost Report Information Healthcare Providers and Systems Medicare & Medicaid Services, 7500 System CAP Competitive Acquisition Program HCUP Healthcare Cost and Utilization Security Boulevard, Baltimore, MD C–APC Comprehensive Ambulatory Project 21244, on Monday through Friday of Payment Classification HEU Highly enriched uranium each week from 8:30 a.m. to 4 p.m. EST. CASPER Certification and Survey Provider HHQRP Home Health Quality Reporting To schedule an appointment to view Enhanced Reporting Program
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HHS Department of Health and Human MS–DRG Medicare severity diagnosis- Table of Contents Services related group HIE Health information exchange MSIS Medicaid Statistical Information I. Summary and Background HIPAA Health Insurance Portability and System A. Executive Summary of This Document Accountability Act of 1996, Public Law MUC Measure under consideration 1. Purpose 104–191 NCCI National Correct Coding Initiative 2. Summary of the Major Provisions HOP Hospital Outpatient Payment [Panel] NEMA National Electrical Manufacturers 3. Summary of Costs and Benefits HOPD Hospital outpatient department Association B. Legislative and Regulatory Authority for HOPQDRP Hospital Outpatient Quality NHSN National Healthcare Safety Network the Hospital OPPS Data Reporting Program NOTA National Organ and Transplantation C. Excluded OPPS Services and Hospitals HPMS Health Plan Management System Act D. Prior Rulemaking IBD Inflammatory bowel disease NOS Not otherwise specified E. Advisory Panel on Hospital Outpatient ICC Interclass correlation coefficient NPI National Provider Identifier Payment (the HOP Panel or the Panel) ICD Implantable cardioverter defibrillator NQF National Quality Forum 1. Authority of the Panel ICD–9–CM International Classification of NQS National Quality Strategy 2. Establishment of the Panel Diseases, Ninth Revision, Clinical NTIOL New technology intraocular lens 3. Panel Meetings and Organizational Modification NUBC National Uniform Billing Committee Structure ICD–10 International Classification of F. Public Comments Received in Response Diseases, Tenth Revision OACT [CMS] Office of the Actuary OBRA Omnibus Budget Reconciliation Act to CY 2017 OPPS/ASC Final Rule With ICH In-center hemodialysis Comment Period ICR Information collection requirement of 1996, Public Law 99–509 O/E Observed to expected event II. Updates Affecting OPPS Payments IDTF Independent diagnostic testing facility A. Recalibration of APC Relative Payment IGI IHS Global, Inc. OIG [HHS] Office of the Inspector General OMB Office of Management and Budget Weights IHS Indian Health Service 1. Database Construction ONC Office of the National Coordinator for I/OCE Integrated Outpatient Code Editor a. Database Source and Methodology Health Information Technology IOL Intraocular lens b. Calculation and Use of Cost-to-Charge OPD [Hospital] Outpatient Department IORT Intraoperative radiation treatment Ratios (CCRs) OPPS [Hospital] Outpatient Prospective IPFQR Inpatient Psychiatric Facility 2. Data Development Process and Payment System Quality Reporting Calculation of Costs Used for Ratesetting OPSF Outpatient Provider-Specific File IPPS [Hospital] Inpatient Prospective a. Calculation of Single Procedure APC OQR [Hospital] Outpatient Quality Payment System Criteria-Based Costs IQR [Hospital] Inpatient Quality Reporting Reporting (1) Blood and Blood Products IRF Inpatient rehabilitation facility OT Occupational therapy (2) Brachytherapy Sources IRFQRP Inpatient Rehabilitation Facility PAMA Protecting Access to Medicare Act of b. Comprehensive APCs (C–APCs) for CY Quality Reporting Program 2014, Public Law 113–93 2018 IT Information technology PCHQR PPS-Exempt Cancer Hospital (1) Background LCD Local coverage determination Quality Reporting LDR Low dose rate (2) C–APCs for CY 2018 PCR Payment-to-cost ratio (3) Brachytherapy Insertion Procedures LTCH Long-term care hospital PDC Per day cost LTCHQR Long-Term Care Hospital Quality (4) C–APC 5627 (Level 7 Radiation) PDE Prescription Drug Event Stereotactic Radiosurgery (SRS) Reporting PE Practice expense MAC Medicare Administrative Contractor (5) Complexity Adjustment for Blue Light PHP Partial hospitalization program Cystoscopy Procedures MACRA Medicare Access and CHIP PHSA Public Health Service Act, Public Reauthorization Act of 2015, Public Law (6) Analysis of C–APC Packaging Under the Law 96–88 OPPS 114–10 PN Pneumonia MAP Measure Application Partnership c. Calculation of Composite APC Criteria- POS Place of service Based Costs MDH Medicare-dependent, small rural PPI Producer Price Index hospital (1) Mental Health Services Composite APC PPS Prospective payment system (2) Multiple Imaging Composite APCs MedPAC Medicare Payment Advisory PQRI Physician Quality Reporting Initiative Commission (APCs 8004, 8005, 8006, 8007, and 8008) PQRS Physician Quality Reporting System 3. Changes to Packaged Items and Services MEG Magnetoencephalography QDC Quality data code MFP Multifactor productivity a. Background and Rationale for Packaging QIO Quality Improvement Organization MGCRB Medicare Geographic Classification in the OPPS RFA Regulatory Flexibility Act Review Board b. CY 2018 Drug Administration Packaging RHQDAPU Reporting Hospital Quality Data MIEA–TRHCA Medicare Improvements and Policies for Annual Payment Update Extension Act under Division B, Title I of (1) Background of Drug Administration the Tax Relief Health Care Act of 2006, RTI Research Triangle Institute, Packaging Policy Public Law 109–432 International (2) Packaging of Level 1 and Level 2 Drug MIPPA Medicare Improvements for Patients RVU Relative value unit Administration Services and Providers Act of 2008, Public Law SAD Self-administered drug (3) Discussion and Summary of Comments 110–275 SAMS Secure Access Management Services Received in Response to Solicitation MLR Medical loss ratio SCH Sole community hospital Regarding Unconditionally Packaging MMA Medicare Prescription Drug, SCOD Specified covered outpatient drugs Drug Administration Add-On Codes Improvement, and Modernization Act of SES Socioeconomic status c. Analysis of Packaging of Pathology 2003, Public Law 108–173 SI Status indicator Services in the OPPS MMEA Medicare and Medicaid Extenders SIA Systems Improvement Agreement d. Summary of Public Comments and Our Act of 2010, Public Law 111–309 SIR Standardized infection ratio Responses Regarding Packaging of Items MMSEA Medicare, Medicaid, and SCHIP SNF Skilled nursing facility and Services Under the OPPS Extension Act of 2007, Public Law 110–173 SRS Stereotactic radiosurgery 4. Calculation of OPPS Scaled Payment MPFS Medicare Physician Fee Schedule SRTR Scientific Registry of Transplant Weights MR Medical review Recipients B. Conversion Factor Update MRA Magnetic resonance angiography SSA Social Security Administration C. Wage Index Changes MRgFUS Magnetic Resonance Image SSI Surgical site infection D. Statewide Average Default CCRs Guided Focused Ultrasound TEP Technical Expert Panel E. Adjustment for Rural Sole Community MRI Magnetic resonance imaging TOPs Transitional Outpatient Payments Hospitals (SCHs) and Essential Access MRSA Methicillin-Resistant VBP Value-based purchasing Community Hospitals (EACHs) Under Staphylococcus Aureus WAC Wholesale acquisition cost Section 1833(t)(13)(B) of the Act
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F. Payment Adjustment for Certain Cancer 8. Discussion of the Comment Solicitation A. OPPS Transitional Pass-Through Hospitals for CY 2018 in the Proposed Rule on Intraocular Payment for Additional Costs of Drugs, 1. Background Procedures APCs Biologicals, and Radiopharmaceuticals 2. Policy for CY 2018 9. Endovascular APCs (C–APCs 5191 1. Background G. Hospital Outpatient Outlier Payments Through 5194) 2. 3-Year Transitional Pass-Through 1. Background 10. Esophagogastroduodenoscopy (C–APC Payment Period for All Pass-Through 2. Outlier Calculation for CY 2018 5362) Drugs, Biologicals, and H. Calculation of an Adjusted Medicare 11. Hemorrhoid Treatment by Thermal Radiopharmaceuticals and Expiration of Payment From the National Unadjusted Energy (APC 5312) Pass-Through Status Medicare Payment 12. Ileoscopy Through Stoma With Stent 3. Drugs and Biologicals With Expiring I. Beneficiary Copayments Placement (C–APC 5303) Pass-Through Payment Status in CY 1. Background 13. Laparoscopic Nephrectomy (C–APC 2017 2. OPPS Copayment Policy 5362) 4. Drugs, Biologicals, and 3. Calculation of an Adjusted Copayment 14. Multianalyte Assays With Algorithmic Radiopharmaceuticals With New or Analyses (MAAA) Amount for an APC Group Continuing Pass-Through Status in CY 15. Musculoskeletal APCs (APCs 5111 III. OPPS Ambulatory Payment Classification 2018 Through 5116) (APC) Group Policies 5. Provisions for Reducing Transitional 16. Nasal/Sinus Endoscopy Procedures (C– Pass-Through Payments for Policy- A. OPPS Treatment of New CPT and Level APC 5155) II HCPCS Codes Packaged Drugs, Biologicals, and 17. Nuclear Medicine Services (APCs 5592 Radiopharmaceuticals to Offset Costs 1. Treatment of New HCPCS Codes That and 5593) Packaged Into APC Groups Were Effective April 1, 2017 for Which 18. Percutaneous Transluminal Mechanical B. OPPS Payment for Drugs, Biologicals, We Solicited Public Comments in the CY Thrombectomy (C–APC 5192) and Radiopharmaceuticals Without Pass- 2018 OPPS/ASC Proposed Rule 19. Peripherally Inserted Central Venous Through Payment Status 2. Treatment of New HCPCS Codes Catheter (APC 5182) 1. Criteria for Packaging Payment for Effective July 1, 2017 for Which We 20. Pulmonary Rehabilitation Services Drugs, Biologicals, and Solicited Public Comments in the CY (APCs 5732 and 5733) and Cardiac Radiopharmaceuticals 2018 OPPS/ASC Proposed Rule Rehabilitation Services (APC 5771) a. Packaging Threshold 3. Process for New Level II HCPCS Codes 21. Radiology and Imaging Procedures and b. Packaging of Payment for HCPCS Codes That Are Effective October 1, 2017 and Services That Describe Certain Drugs, Certain January 1, 2018 for Which We Are a. Imaging APCs Biologicals, and Therapeutic Soliciting Public Comments in This CY b. Non-Ophthalmic Fluorescent Vascular Radiopharmaceuticals Under the Cost Angiography (APC 5523) 2018 OPPS/ASC Final Rule With Threshold (‘‘Threshold-Packaged 22. Sclerotherapy (APC 5054) Comment Period Policy’’) 23. Skin Substitutes (APCs 5053, 5054, and 4. Treatment of New and Revised CY 2018 c. Policy Packaged Drugs, Biologicals, and 5055) Category I and III CPT Codes That Are Radiopharmaceuticals 24. Subdermal Drug Implants for the Effective January 1, 2018 for Which We d. High Cost/Low Cost Threshold for Treatment of Opioid Addiction (APC Solicited Public Comments in the CY Packaged Skin Substitutes 2018 OPPS/ASC Proposed Rule 5735) 25. Suprachoroidal Delivery of e. Packaging Determination for HCPCS B. OPPS Changes—Variations Within APCs Codes That Describe the Same Drug or 1. Background Pharmacologic Agent (APC 5694) 26. Transperineal Placement of Biological But Different Dosages 2. Application of the 2 Times Rule 2. Payment for Drugs and Biologicals 3. APC Exceptions to the 2 Times Rule Biodegradable Material (C–APC 5375) 27. Transcranial Magnetic Stimulation Without Pass-Through Status That Are C. New Technology APCs Not Packaged 1. Background Therapy (TMS) (APCs 5721 and 5722) 28. Transurethral Waterjet Ablation of a. Payment for Specified Covered 2. Revised and Additional New Outpatient Drugs (SCODs) and Other Technology APC Groups Prostate (C–APC 5375) 29. Transurethral Water Vapor Thermal Separately Payable and Packaged Drugs 3. Procedures Assigned to New Technology and Biologicals APC Groups for CY 2018 Therapy of Prostate (C–APC 5373) IV. OPPS Payment for Devices b. CY 2018 Payment Policy a. Overall Policy A. Pass-Through Payments for Devices c. Biosimilar Biological Products b. Magnetic Resonance-Guided Focused 1. Beginning Eligibility Date for Device 3. Payment Policy for Therapeutic Ultrasound Surgery (MRgFUS) (APCs Pass-Through Status and Quarterly Radiopharmaceuticals 1537, 5114, and 5415) Expiration of Device Pass-Through 4. Payment Adjustment Policy for c. Retinal Prosthesis Implant Procedure Payments Radioisotopes Derived From Non-Highly d. Pathogen Test for Platelets a. Background Enriched Uranium Sources e. Fractional Flow Reserve Derived From b. Expiration of Transitional Pass-Through 5. Payment for Blood Clotting Factors Computed Tomography (FFRCT) Payment for Certain Devices 6. Payment for Nonpass-Through Drugs, D. OPPS APC-Specific Policies 2. New Device Pass-Through Applications Biologicals, and Radiopharmaceuticals 1. Blood-Driven Hematopoietic Cell a. Background With HCPCS Codes But Without OPPS Harvesting b. Applications Received for Device Pass- Hospital Claims Data 2. Brachytherapy Insertion Procedures (C– Through Payment for CY 2018 7. Alternative Payment Methodology for APCs 5341 and 5092) B. Device-Intensive Procedures Drugs Purchased Under the 340B a. C–APC 5341 (Abdominal/Peritoneal/ 1. Background Program Biliary and Related Procedures) 2. HCPCS Code-Level Device-Intensive a. Background b. C–APC 5092 (Level 2 Breast/Lymphatic Determination b. OPPS Payment Rate for 340B Purchased Surgery and Related Procedures) 3. Device Edit Policy Drugs 3. Care Management Coding Changes 4. Adjustment to OPPS Payment for No c. Summaries of Public Comments Effective January 1, 2018 (APCs 5821 and Cost/Full Credit and Partial Credit Received and Our Responses 5822) Devices d. Summary of Final Policies for CY 2018 4. Cardiac Telemetry (APC 5721) a. Background e. Comment Solicitation on Additional 5. Collagen Cross-Linking of Cornea (C– b. Policy for No Cost/Full Credit and 340B Considerations APC 5503) Partial Credit Devices VI. Estimate of OPPS Transitional Pass- 6. Cryoablation Procedures for Lung 5. Payment Policy for Low-Volume Device- Through Spending for Drugs, Biologicals, Tumors (C–APC 5361) Intensive Procedures Radiopharmaceuticals, and Devices 7. Diagnostic Bone Marrow Aspiration and V. OPPS Payment Changes for Drugs, A. Background Biopsy (C–APC 5072) Biologicals, and Radiopharmaceuticals B. Estimate of Pass-Through Spending
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VII. OPPS Payment for Hospital Outpatient XII. Updates to the Ambulatory Surgical 1. NTIOL Application Cycle Visits and Critical Care Services Center (ASC) Payment System 2. Requests To Establish New NTIOL VIII. Payment for Partial Hospitalization A. Background Classes for CY 2018 Services 1. Legislative History, Statutory Authority, 3. Payment Adjustment A. Background and Prior Rulemaking for the ASC 4. Announcement of CY 2019 Deadline for B. PHP APC Update for CY 2018 Payment System Submitting Requests for CMS Review of 1. PHP APC Geometric Mean per Diem 2. Policies Governing Changes to the Lists Applications for a New Class of NTIOLs Costs of Codes and Payment Rates for ASC F. ASC Payment and Comment Indicators 2. Development of the PHP APC Geometric Covered Surgical Procedures and 1. Background Mean per Diem Costs Covered Ancillary Services 2. ASC Payment and Comment Indicators a. CMHC Data Preparation: Data Trims, 3. Definition of ASC Covered Surgical G. Calculation of the ASC Conversion Exclusions, and CCR Adjustments Procedures Factor and the ASC Payment Rates b. Hospital-Based PHP Data Preparation: B. Treatment of New and Revised Codes 1. Background Data Trims and Exclusions 1. Background on Current Process for 2. Calculation of the ASC Payment Rates 3. PHP Service Utilization Updates Recognizing New and Revised Category a. Updating the ASC Relative Payment 4. Minimum Service Requirement: 20 I and Category III CPT Codes and Level Weights for CY 2018 and Future Years Hours per Week II HCPCS Codes b. Updating the ASC Conversion Factor C. Outlier Policy for CMHCs 2. Treatment of New and Revised Level II 3. Discussion of Comment Solicitation on IX. Procedures That Will Be Paid Only as HCPCS Codes Implemented in April ASC Payment System Reform Inpatient Procedures 2017 for Which We Solicited Public 4. Display of CY 2018 ASC Payment Rates A. Background Comments in the CY 2018 Proposed Rule XIII. Requirements for the Hospital B. Changes to the Inpatient Only (IPO) List 3. Treatment of New and Revised Level II Outpatient Quality Reporting (OQR) 1. Methodology for Identifying Appropriate HCPCS Codes Implemented in July 2017 Program Changes to IPO List for Which We Solicited Public A. Background 2. Removal of Procedures Described by Comments in the CY 2018 Proposed Rule 1. Overview CPT Code 55866 4. Process for New and Revised Level II 2. Statutory History of the Hospital OQR 3. Removal of the Total Knee Arthroplasty HCPCS Codes That Are Effective October Program (TKA) Procedure Described by CPT Code 1, 2017 and January 1, 2018 for Which 3. Regulatory History of the Hospital OQR 27447 We Are Soliciting Public Comments in Program 4. Recovery Audit Contractor (RAC) this CY 2018 OPPS/ASC Final Rule With B. Hospital OQR Program Quality Measures Review of TKA Procedures Comment Period 1. Considerations in the Selection of 5. Public Requests for Additions to or 5. Process for Recognizing New and Hospital OQR Program Quality Measures Removal of Procedures on the IPO List Revised Category I and Category III CPT 2. Accounting for Social Risk Factors in the 6. Summary of Changes to the IPO List for Codes That Are Effective January 1, 2018 Hospital OQR Program CY 2018 for Which We Are Soliciting Public 3. Retention of Hospital OQR Program C. Discussion of Solicitation of Public Comments in This CY 2018 OPPS/ASC Measures Adopted in Previous Payment Comments on the Possible Removal of Final Rule With Comment Period Determinations Partial Hip Arthroplasty (PHA) and Total C. Update to the List of ASC Covered 4. Removal of Quality Measures From the Hip Arthroplasty (THA) Procedures Surgical Procedures and Covered Hospital OQR Program Measure Set From the IPO List Ancillary Services a. Considerations in Removing Quality 1. Background 1. Covered Surgical Procedures Measures From the Hospital OQR 2. Topics and Questions Posed for Public a. Covered Surgical Procedures Designated Program Comments as Office-Based b. Criteria for Removal of ‘‘Topped-Out’’ X. Nonrecurring Policy Changes (1) Background Measures A. Payment for Certain Items and Services (2) Changes for CY 2018 to Covered c. Measure Removal From the Hospital Furnished by Certain Off-Campus Surgical Procedures Designated as OQR Program Measure Set Departments of a Provider Office-Based 5. Make Reporting of OP–37a–e: Outpatient 1. Background b. ASC Covered Surgical Procedures and Ambulatory Surgery Consumer 2. Expansion of Services by Excepted Off- Designated as Device-Intensive Assessment of Healthcare Providers and Campus Hospital Outpatient (1) Background Systems (OAS CAHPS) Survey-Based Departments (2) Changes to List of ASC Covered Measures Voluntary for CY 2018 3. Section 16002 of the 21st Century Cures Surgical Procedures Designated as Reporting and Subsequent Years Act (Treatment of Cancer Hospitals in Device-Intensive for CY 2018 6. Previously Adopted Hospital OQR Off-Campus Outpatient Department of a c. Adjustment to ASC Payments for No Program Measure Set for the CY 2020 Provider Policy) Cost/Full Credit and Partial Credit Payment Determination and Subsequent B. Medicare Site-of-Service Price Devices Years Transparency (Section 4011 of the 21st d. Additions to the List of ASC Covered 7. Newly Finalized Hospital OQR Program Century Cures Act) Surgical Procedures Measure Set for the CY 2020 Payment C. Appropriate Use Criteria for Advanced e. Discussion of Comment Solicitation on Determination and Subsequent Years Diagnostic Imaging Services Adding Additional Procedures to the 8. Hospital OQR Program Measures and D. Enforcement Instruction for the ASC Covered Procedures List Topics for Future Consideration Supervision of Outpatient Therapeutic 2. Covered Ancillary Services a. Future Measure Topics Services in Critical Access Hospitals D. ASC Payment for Covered Surgical b. Possible Future Adoption of the (CAHs) and Certain Small Rural Procedures and Covered Ancillary Electronic Version of OP–2: Fibrinolytic Hospitals Services Therapy Received Within 30 Minutes of E. Payment Changes for Film X-Rays 1. ASC Payment for Covered Surgical Emergency Department Arrival Services and Payment Changes for X- Procedures 9. Maintenance of Technical Specifications Rays Taken Using Computed a. Background for Quality Measures Radiography Technology b. Update to ASC Covered Surgical 10. Public Display of Quality Measures F. Revisions to the Laboratory Date of Procedure Payment Rates for CY 2018 a. Background Service Policy 2. Payment for Covered Ancillary Services b. Public Reporting of OP–18c: Median XI. CY 2018 OPPS Payment Status and a. Background Time From Emergency Department Comment Indicators b. Payment for Covered Ancillary Services Arrival to Emergency Department A. CY 2018 OPPS Payment Status Indicator for CY 2018 Departure for Discharged Emergency Definitions E. New Technology Intraocular Lenses Department Patients—Psychiatric/ B. CY 2018 Comment Indicator Definitions (NTIOLs) Mental Health Patients
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C. Administrative Requirements 3. Policies for Retention and Removal of E. Payment Reduction for ASCs That Fail 1. QualityNet Account and Security Quality Measures From the ASCQR To Meet the ASCQR Program Administrator Program Requirements 2. Requirements Regarding Participation a. Retention of Previously Adopted ASCQR 1. Statutory Background Status Program Measures 2. Reduction to the ASC Payment Rates for a. Background b. Measure Removal ASCs That Fail To Meet the ASCQR b. Changes to the NOP Submission 4. Delay of ASC–15a–e: Outpatient and Program Requirements for a Payment Deadline Ambulatory Surgery Consumer Determination Year D. Form, Manner, and Timing of Data Assessment of Healthcare Providers and XV. Files Available to the Public via the Submitted for the Hospital OQR Program Systems (OAS CAHPS) Survey-Based Internet 1. Hospital OQR Program Annual Payment Measures Beginning With the 2020 XVI. Collection of Information Requirements Determinations Payment Determination A. Statutory Requirement for Solicitation 2. Requirements for Chart-Abstracted 5. ASCQR Program Quality Measures of Comments Measures Where Patient-Level Data Are Adopted in Previous Rulemaking B. ICRs for the Hospital OQR Program Submitted Directly to CMS for the CY 6. ASCQR Program Quality Measures for C. ICRs for the ASCQR Program 2021 Payment Determination and the CY 2021 and CY 2022 Payment XVII. Response to Comments Subsequent Years Determinations and Subsequent Years XVIII. Economic Analyses 3. Claims-Based Measure Data a. Adoption of ASC–16: Toxic Anterior A. Regulatory Impact Analysis Requirements for the CY 2020 Payment Segment Syndrome Beginning With the 1. Introduction 2. Statement of Need Determination and Subsequent Years CY 2021 Payment Determination 3. Overall Impacts for the OPPS and ASC 4. Data Submission Requirements for OP– b. Adoption of ASC–17: Hospital Visits 37a–e: Outpatient and Ambulatory Payment Provisions After Orthopedic Ambulatory Surgical Surgery Consumer Assessment of 4. Regulatory Review Costs Center Procedures Beginning With the Healthcare Providers and Systems (OAS 5. Detailed Economic Analyses CY 2022 Payment Determination CAHPS) Survey-Based Measures for the a. Estimated Effects of OPPS Changes in c. Adoption of ASC–18: Hospital Visits CY 2020 Payment Determination and This Final Rule With Comment Period After Urology Ambulatory Surgical Subsequent Years (1) Limitations of Our Analysis Center Procedures Beginning With the 5. Data Submission Requirements for (2) Estimated Effects of OPPS Changes to CY 2022 Payment Determination Previously Finalized Measures for Data Part B Drug Payment on 340B Eligible d. Summary of Previously Adopted Submitted via a Web-Based Tool for the Hospitals Paid Under the OPPS Measurers and Newly Adopted ASCQR CY 2020 Payment Determination and (3) Estimated Effects of OPPS Changes on Program Measures for the CY 2022 Subsequent Years Hospitals Payment Determination and Subsequent 6. Population and Sampling Data (4) Estimated Effects of OPPS Changes on Requirements for the CY 2020 Payment Years CMHCs Determination and Subsequent Years 7. ASCQR Program Measures and Topics (5) Estimated Effects of OPPS Changes on 7. Hospital OQR Program Validation for Future Consideration Beneficiaries Requirements for Chart-Abstracted 8. Maintenance of Technical Specifications (6) Estimated Effects of OPPS Changes on Measure Data Submitted Directly to CMS for Quality Measures Other Providers for the CY 2020 Payment Determination 9. Public Reporting of ASCQR Program (7) Estimated Effects of OPPS Changes on and Subsequent Years Data the Medicare and Medicaid Programs a. Clarification C. Administrative Requirements (8) Alternative OPPS Policies Considered b. Codification 1. Requirements Regarding QualityNet b. Estimated Effects of CY 2018 ASC c. Modifications to the Educational Review Account and Security Administrator Payment System Policies Process for Chart-Abstracted Measures 2. Requirements Regarding Participation (1) Limitations of Our Analysis Validation Status (2) Estimated Effects of CY 2018 ASC 8. Extraordinary Circumstances Exception D. Form, Manner, and Timing of Data Payment System Policies on ASCs Process for the CY 2020 Payment Submitted for the ASCQR Program (3) Estimated Effects of ASC Payment Determination and Subsequent Years 1. Requirements Regarding Data Processing System Policies on Beneficiaries a. ECE Policy Nomenclature and Collection Periods for Claims-Based (4) Alternative ASC Payment Policies b. Timeline for CMS Response to ECE Measures Using Quality Data Codes Considered Requests (QDCs) c. Accounting Statements and Tables 9. Hospital OQR Program Reconsideration 2. Minimum Threshold, Minimum Case d. Effects of Requirements for the Hospital and Appeals Procedures for the CY 2020 Volume, and Data Completeness for OQR Program Payment Determination and Subsequent Claims-Based Measures Using QDCs e. Effects of Requirements for the ASCQR Years 3. Requirements for Data Submitted via an Program E. Payment Reduction for Hospitals That Online Data Submission Tool B. Regulatory Flexibility Act (RFA) Fail To Meet the Hospital OQR Program a. Requirements for Data Submitted via a Analysis Requirements for the CY 2018 Payment Non-CMS Online Data Submission Tool C. Unfunded Mandates Reform Act Determination b. Requirements for Data Submitted via a Analysis 1. Background CMS Online Data Submission Tool D. Reducing Regulation and Controlling 2. Reporting Ratio Application and 4. Requirements for Claims-Based Measure Regulatory Costs Associated Adjustment Policy for CY Data E. Conclusion 2018 5. Requirements for Data Submission for XIX. Federalism Analysis XIV. Requirements for the Ambulatory ASC–15a–e: Outpatient and Ambulatory Regulation Text Surgical Center Quality Reporting Surgery Consumer Assessment of (ASCQR) Program Healthcare Providers and Systems (OAS I. Summary and Background A. Background CAHPS) Survey-Based Measures A. Executive Summary of This 1. Overview 6. Extraordinary Circumstances Extensions Document 2. Statutory History of the ASCQR Program or Exemptions for the CY 2019 Payment 3. Regulatory History of the ASCQR Determination and Subsequent Years 1. Purpose Program a. Background B. ASCQR Program Quality Measures b. ECE Policy Nomenclature In this final rule with comment 1. Considerations in the Selection of c. Timeline for CMS Response to ECE period, we are updating the payment ASCQR Program Quality Measures Requests policies and payment rates for services 2. Accounting for Social Risk Factors in the 7. ASCQR Program Reconsideration furnished to Medicare beneficiaries in ASCQR Program Procedures hospital outpatient departments
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(HOPDs) and ambulatory surgical addition, for CY 2018, we are reduction and another for hospitals not centers (ASCs) beginning January 1, establishing that a skin substitute subject to the payment reduction but 2018. Section 1833(t) of the Social product that does not exceed either the that acquire drugs under the 340B Security Act (the Act) requires us to CY 2018 MUC or PDC threshold for CY Program. annually review and update the 2018, but was assigned to the high cost • Device Pass-Through Payment payment rates for services payable group for CY 2017, is assigned to the Applications: For CY 2018, we under the Hospital Outpatient high cost group for CY 2018. The goal evaluated five devices for eligibility to Prospective Payment System (OPPS). of our policy is to maintain similar receive pass through payments and Specifically, section 1833(t)(9)(A) of the levels of payment for skin substitute sought public comments in the CY 2018 Act requires the Secretary to review products for CY 2018 while we study proposed rule on whether each of these certain components of the OPPS not less our current skin substitute payment items meet the criteria for device pass- often than annually, and to revise the methodology to determine whether through payment status. None of the groups, relative payment weights, and refinements to our existing applications were approved for device other adjustments that take into account methodologies may be warranted. pass-through payments for CY 2018. changes in medical practices, changes in • Supervision of Hospital Outpatient • Rural Adjustment: We are technologies, and the addition of new Therapeutic Services: In the CY 2009 continuing the adjustment of 7.1 percent services, new cost data, and other and CY 2010 OPPS/ASC proposed rules to the OPPS payments to certain rural relevant information and factors. In and final rules with comment period, SCHs, including essential access addition, under section 1833(i) of the we clarified that direct supervision is community hospitals (EACHs). This Act, we annually review and update the required for hospital outpatient adjustment will apply to all services ASC payment rates. We describe these therapeutic services covered and paid paid under the OPPS, excluding and various other statutory authorities by Medicare that are furnished in separately payable drugs and in the relevant sections of this final rule hospitals, CAHs, and in provider-based biologicals, devices paid under the pass- with comment period. In addition, this departments (PBDs) of hospitals, as set through payment policy, and items paid final rule with comment period updates forth in the CY 2000 OPPS final rule at charges reduced to cost. and refines the requirements for the with comment period. For several years, • Cancer Hospital Payment Hospital Outpatient Quality Reporting there has been a moratorium on the Adjustment: For CY 2018, we are (OQR) Program and the ASC Quality enforcement of the direct supervision continuing to provide additional Reporting (ASCQR) Program. requirement for CAHs and small rural payments to cancer hospitals so that the hospitals, with the latest moratorium on cancer hospital’s payment-to-cost ratio 2. Summary of the Major Provisions enforcement expiring on December 31, (PCR) after the additional payments is • OPPS Update: For CY 2018, we are 2016. In this final rule with comment equal to the weighted average PCR for increasing the payment rates under the period, as we proposed, we are the other OPPS hospitals using the most OPPS by an Outpatient Department reinstating the nonenforcement policy recently submitted or settled cost report (OPD) fee schedule increase factor of for direct supervision of outpatient data. However, beginning CY 2018, 1.35 percent. This increase factor is therapeutic services furnished in CAHs section 16002(b) of the 21st Century based on the hospital inpatient market and small rural hospitals having 100 or Cures Act requires that this weighted basket percentage increase of 2.7 fewer beds and reinstating our average PCR be reduced by 1.0 percent for inpatient services paid enforcement instruction for CY 2018 percentage point. Based on the data and under the hospital inpatient prospective and CY 2019. the required 1.0 percentage point payment system (IPPS), minus the • 340B Drug Pricing: We are changing reduction, a target PCR of 0.88 will be multifactor productivity (MFP) our current Medicare Part B drug used to determine the CY 2018 cancer adjustment of 0.6 percentage point, and payment methodology for 340B hospital payment adjustment to be paid minus a 0.75 percentage point hospitals that we believe will better, and at cost report settlement. That is, the adjustment required by the Affordable more appropriately, reflect the resources payment adjustments will be the Care Act. Based on this update, we and acquisition costs that these additional payments needed to result in estimate that total payments to OPPS hospitals incur. These changes will a PCR equal to 0.88 for each cancer providers (including beneficiary cost- lower drug costs for Medicare hospital. sharing and estimated changes in beneficiaries for drugs acquired by • Changes to the Inpatient Only List: enrollment, utilization, and case-mix) hospitals under the 340B Program. For For CY 2018, we are finalizing our for CY 2018 is approximately $70 CY 2018, we are exercising the proposal to remove total knee billion, an increase of approximately Secretary’s authority to adjust the arthroplasty (TKA) from the inpatient $5.8 billion compared to estimated CY applicable payment rate as necessary for only list. In addition, we are precluding 2017 OPPS payments. separately payable drugs and biologicals the Recovery Audit Contractors from We are continuing to implement the (other than drugs on pass-through reviewing TKA procedures for ‘‘patient statutory 2.0 percentage point reduction payment status and vaccines) acquired status’’ (that is, site of service) for a in payments for hospitals failing to meet under the 340B Program from average period of 2 years. We note that we will the hospital outpatient quality reporting sales price (ASP) plus 6 percent to ASP monitor changes in site of service to requirements, by applying a reporting minus 22.5 percent. Rural sole determine whether changes may be factor of 0.980 to the OPPS payments community hospitals (SCHs), children’s necessary to certain CMS Innovation and copayments for all applicable hospitals, and PPS-exempt cancer Center models. In addition, we are services. hospitals are excluded from this removing five other procedures from the • High Cost/Low Cost Threshold for payment adjustment in CY 2018. In inpatient only list and adding one Packaged Skin Substitutes: As we did addition, in this final rule with procedure to the list. for CY 2017, we are assigning skin comment period, we are establishing • Comprehensive APCs: For CY 2018, substitutes with a geometric mean unit two modifiers to identify whether a drug we did not propose to create any new cost (MUC) or a per day cost (PDC) that billed under the OPPS was purchased C–APCs or make any extensive changes exceeds either the MUC threshold or the under the 340B Program—one for to the already established methodology PDC threshold to the high cost group. In hospitals that are subject to the payment used for C–APCs. There will be a total
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number of 62 C–APCs as of January 1, code to describe imaging services that molecular pathology tests and advanced 2018. For CY 2018, for the C–APC for are taken using computed radiography diagnostic laboratory tests (ADLTs) stereotactic radio surgery (SRS), technology beginning January 1, 2018. under the new private payor rate-based specifically, C–APC 5627 (Level 7 • ASC Payment Update: For CY 2018, Clinical Laboratory Fee Schedule Radiation Therapy), we are continuing we are increasing payment rates under (CLFS), in the CY 2018 proposed rule, to make separate payments for the 10 the ASC payment system by 1.2 percent we solicited public comments on billing planning and preparation services for ASCs that meet the quality reporting for molecular pathology tests and adjunctive to the delivery of the SRS requirements under the ASCQR certain ADLTs ordered less than 14 days treatment using either the Cobalt-60- Program. This increase is based on a of a hospital outpatient discharge and based or LINAC-based technology when projected CPI–U update of 1.7 percent discussed potential modifications to our furnished to a beneficiary within 30 minus a multifactor productivity DOS policy to address those tests. After days of the SRS treatment. In addition, adjustment required by the Affordable considering the public comments the data collection period for SRS Care Act of 0.5 percentage point. Based received, we are adding an additional claims with modifier ‘‘CP’’ is set to on this update, we estimate that total exception to our current laboratory DOS conclude on December 31, 2017. payments to ASCs (including regulations at 42 CFR 414.510. This new Accordingly, for CY 2018, we are beneficiary cost-sharing and estimated exception to the laboratory DOS policy deleting this modifier and discontinuing changes in enrollment, utilization, and generally permits laboratories to bill its required use. case-mix) for CY 2018 is approximately Medicare directly for ADLTs and • Packaging Policies: In CY 2015, we $4.62 billion, an increase of molecular pathology tests excluded implemented a policy to conditionally approximately $130 million compared from OPPS packaging policy if the package ancillary services assigned to to estimated CY 2017 Medicare specimen was collected from a hospital APCs with a geometric mean cost of payments. In addition, in the CY 2018 outpatient during a hospital outpatient $100 or less prior to packaging, with proposed rule, we solicited comment on encounter and the test was performed some exceptions, including drug payment reform for ASCs, including the following the patient’s discharge from administration services. For CY 2018, collection of cost data which may the hospital outpatient department. We we are removing the exception for support a rate update other than CPI–U. discuss the public comments we certain drug administration services and We discuss the public comments that received on this solicitation in this final conditionally packaging payment for we received in response to this rule with comment period. low-cost drug administration services. solicitation in this final rule with • We did not propose to package drug comment period. Hospital Outpatient Quality administration add-on codes for CY • Comment Solicitation on ASC Reporting (OQR) Program: For the 2018, but solicited comments on this Payment Reform: In the CY 2018 Hospital OQR Program, we are policy. The public comments that we proposed rule, we indicated that we finalizing our proposals to remove and received are discussed in this final rule were broadly interested in feedback delay certain measures for the CY 2020 with comment period. In addition, we from stakeholders and other interested payment determination and subsequent solicited comments on existing parties on potential reforms to the years. Specifically, beginning with the packaging policies that exist under the current payment system, including, but CY 2020 payment determination, we are OPPS, including those related to drugs not limited to (1) the rate update factor finalizing our proposals to remove: (1) that function as a supply in a diagnostic applied to ASC payments, (2) whether OP–21: Median Time to Pain test or procedure or in a surgical and how ASCs should submit data Management for Long Bone Fracture; procedure. The public comments that relating to costs, (3) whether ASCs and (2) OP–26: Hospital Outpatient we received are also discussed in this should bill on the institutional claim Volume Data on Selected Outpatient final rule with comment period. form rather than the professional claim Surgical Procedures. While we proposed • Payment Changes for X-rays Taken form, and (4) other ideas to improve to remove: OP–1: Median Time to Using Computed Radiography payment accuracy for ASCs. We discuss Fibrinolysis, OP–4: Aspirin at Arrival, Technology: Section 502(b) of Division the feedback we received in this final OP–20: Door to Diagnostic Evaluation O, Title V of the Consolidated rule with comment period. by a Qualified Medical Professional, and Appropriations Act, 2016 (Pub. L. 114– • Changes to the List of ASC Covered OP–25: Safe Surgery Checklist for the 113) amended section 1833(t)(16) of the Surgical Procedures: For CY 2018, we CY 2021 payment determination and Act by adding new subparagraph (F). are adding three procedures to the ASC subsequent years, we are finalizing New section 1833(t)(16)(F)(ii) of the Act covered procedures list. In addition, in these proposals with modification, such provides for a phased-in reduction of the CY 2018 proposed rule, we solicited that we are removing them for the CY payments for imaging services that are comment on whether total knee 2020 payment determination and taken using computed radiography arthroplasty, partial hip arthroplasty subsequent years, one year earlier than technology. That section provides that and total hip arthroplasty meet the proposed. We are also finalizing our payments for such services furnished criteria to be added to the ASC covered proposal to delay the OAS CAHPS during CYs 2018 through 2022 shall be procedures list. We also solicited Survey-based measures (OP–37a–e) reduced by 7 percent, and if such comments from stakeholders on beginning with the CY 2020 payment services are furnished during CY 2023 whether there are codes that are outside determination (CY 2018 reporting). In or a subsequent year, payments for such the AMA–CPT surgical code range that addition, for the CY 2020 payment services shall be reduced by 10 percent. nonetheless, should be considered to be determination and subsequent years we We are establishing a new modifier that a covered surgical procedure. We are: (1) Providing clarification on our will be reported on claims to identify discuss the public comments we procedures for validation of chart- those HCPCS codes that describe X-rays received on this solicitation in this final abstracted measures for targeting the taken using computed radiography rule with comment period. poorest performing outlier hospitals; (2) technology. Specifically, this modifier, • Revisions to the Laboratory Date of formalizing the validation educational as allowed under the provisions of new Service Policy: To better understand the review process and updating it to allow section 1833(t)(16)(F)(ii) of the Act, will potential impact of the current date of corrections of incorrect validation be reported with the applicable HCPCS service (DOS) policy on billing for results for chart-abstracted measures,
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and modifying the CFR accordingly; (3) Hospital Visits after Urology 99m without HEU are technologically aligning the first quarter for which to Ambulatory Surgical Center Procedures. and economically viable, and submit data for hospitals that did not Response: We appreciate the conversion to such production has participate in the previous year’s commenters’ support. However, as we begun. We expect that this change in the Hospital OQR Program and make stated earlier in section V.B.1.c. of this supply source for the radioisotope used corresponding changes to the CFR; and final rule with comment period in for modern medical imaging will (4) aligning the naming of the response to a similar request for introduce new costs into the payment Extraordinary Circumstances Exceptions additional radiopharmaceutical system that are not accounted for in the (ECE) policy with that used in our other payment, we continue to believe that a historical claims data. quality reporting and value-based single payment is appropriate for Therefore, beginning in CY 2013, we payment programs and making radiopharmaceuticals with pass-through finalized a policy to provide an corresponding changes to the CFR. We payment status in CY 2018 and that the additional payment of $10 for the are not finalizing our proposal to extend payment rate of ASP+6 percent is marginal cost for radioisotopes the Notice of Participation (NOP) appropriate to provide payment for both produced by non-HEU sources (77 FR deadline and make corresponding the radiopharmaceutical’s acquisition 68323). Under this policy, hospitals changes to the CFR. Lastly, we are cost and any associated nuclear report HCPCS code Q9969 (Tc-99m from finalizing with modifications, our medicine handling and compounding non-highly enriched uranium source, proposal to publicly report OP–18c: costs incurred by the hospital full cost recovery add-on per study Median Time from Emergency pharmacy. Payment for the dose) once per dose along with any Department Arrival to Emergency radiopharmaceutical and diagnostic scan or scans furnished using Department Departure for Discharged radiopharmaceutical processing services Tc-99m as long as the Tc-99m doses Emergency Department Patients— is made through the single ASP-based used can be certified by the hospital to Psychiatric/Mental Health Patients. payment. We refer readers to the CMS be at least 95 percent derived from non- guidance document available via the HEU sources (77 FR 68321). • Ambulatory Surgical Center Quality Internet at https://www.cms.gov/ We stated in the CY 2013 OPPS/ASC Reporting (ASCQR) Program: For the Medicare/Medicare-Fee-for-Service- final rule with comment period (77 FR ASCQR Program, we are finalizing Payment/HospitalOutpatientPPS/ 68321) that our expectation is that this measures and policies for the CY 2019 Archives.html for details on submission additional payment will be needed for payment determination, 2021 payment of ASP data for therapeutic the duration of the industry’s determination, and CY 2022 payment radiopharmaceuticals. conversion to alternative methods to determination and subsequent years. After consideration of the public producing Tc-99m without HEU. We Specifically, we are finalizing our comments we received, we are also stated that we would reassess, and proposals to, beginning with the CY finalizing our proposal, without propose if necessary, on an annual basis 2019 payment determination, remove modification, to continue to pay all whether such an adjustment continued three measures from the ASCQR nonpass-through, separately payable to be necessary and whether any Program measure set: (1) ASC–5: therapeutic radiopharmaceuticals at changes to the adjustment were Prophylactic Intravenous (IV) Antibiotic ASP+6 percent. We also are finalizing warranted (77 FR 68316). We have Timing; (2) ASC–6: Safe Surgery our proposal to continue to rely on CY reassessed this payment for CY 2018 Checklist Use; and, (3) ASC–7: 2016 mean unit cost data derived from and did not identify any new Ambulatory Surgical Center Facility hospital claims data for payment rates information that would cause us to Volume Data on Selected Ambulatory for therapeutic radiopharmaceuticals for modify payment. Therefore, in the CY Surgical Center Surgical Procedures. In which ASP data are unavailable. The CY 2018 OPPS/ASC proposed rule (82 FR addition, we are also finalizing our 2018 final rule payment rates for 33631), for CY 2018, we proposed to proposal to delay the OAS CAHPS nonpass-through separately payable continue to provide an additional $10 Survey measures (ASC–15a–e) therapeutic radiopharmaceuticals are payment for radioisotopes produced by beginning with the CY 2020 payment included in Addenda A and B to this non-HEU sources. determination (CY 2018 data collection). final rule with comment period (which Comment: Commenters supported Furthermore, starting with CY 2018, we are available via the Internet on the CMS’ proposal to provide an additional are finalizing our proposals to: (1) CMS Web site). $10 payment for the marginal cost of Expand the CMS online tool to also radioisotopes produced by non-HEU allow for batch submission of measure 4. Payment Adjustment Policy for sources and supported continuation of data and make corresponding changes to Radioisotopes Derived From Non- the policy. However, the commenters the CFR; and (2) align the naming of the Highly Enriched Uranium Sources requested that CMS update the payment Extraordinary Circumstances Exceptions Radioisotopes are widely used in amount using the hospital market basket (ECE) policy with that used in our other modern medical imaging, particularly update or hospital cost data. The quality reporting and value-based for cardiac imaging and predominantly commenters also requested that CMS payment programs and make for the Medicare population. Some of assess whether the collection of a corresponding changes to the CFR. We the Technetium-99 (Tc-99m), the beneficiary copayment could discourage are not finalizing our proposal to adopt radioisotope used in the majority of hospital adoption. one new measure, ASC–16: Toxic such diagnostic imaging services, is Response: We appreciate the Anterior Segment Syndrome, beginning produced in legacy reactors outside of commenters’ support. As discussed in with the CY 2021 payment the United States using highly enriched the CY 2013 OPPS/ASC final rule with determination. However, we are uranium (HEU). comment period, we did not finalize a finalizing proposals to adopt two new The United States would like to policy to use the usual OPPS measures collected via claims, eliminate domestic reliance on these methodologies to update the non-HEU beginning with the CY 2022 payment reactors, and is promoting the add-on payment (77 FR 68317). The determination, ASC–17: Hospital Visits conversion of all medical radioisotope purpose for the additional payment is after Orthopedic Ambulatory Surgical production to non-HEU sources. limited to mitigating any adverse impact Center Procedures and ASC–18: Alternative methods for producing Tc- of transitioning to non-HEU sources and
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is based on the authority set forth at continue our policy for payment of the Section 1833(t)(6) of the Act provides section 1833(t)(2)(E) of the Act. furnishing fee using an updated amount. for temporary additional payments, Accordingly, because we do not have Our policy to pay for a furnishing fee for which we refer to as ‘‘transitional pass- authority to waive beneficiary blood clotting factors under the OPPS is through payments,’’ for at least 2 but not copayment for this incentive payment, consistent with the methodology more than 3 years for certain drugs, we believe it is unnecessary to assess applied in the physician’s office and in biological agents, brachytherapy devices whether a beneficiary copayment the inpatient hospital setting. These used for the treatment of cancer, and liability would deter a hospital from methodologies were first articulated in categories of other medical devices. For reporting HCPCS code Q9969. the CY 2006 OPPS final rule with new technology services that are not Furthermore, reporting of HCPCS code comment period (70 FR 68661) and later eligible for transitional pass-through Q9969 is optional. Hospitals that are not discussed in the CY 2008 OPPS/ASC payments, and for which we lack experiencing high volumes of final rule with comment period (72 FR sufficient clinical information and cost significantly increased costs are not 66765). The proposed furnishing fee data to appropriately assign them to a obligated to request this additional update was based on the percentage clinical APC group, we have established payment (77 FR 68323). increase in the Consumer Price Index special APC groups based on costs, Comment: One commenter requested (CPI) for medical care for the 12-month which we refer to as New Technology that CMS publish HCPCS code volume period ending with June of the previous APCs. These New Technology APCs are and cost data in the proposed and final year. Because the Bureau of Labor designated by cost bands which allow rule ‘‘Drug Blood Brachy Cost Statistics’’ Statistics releases the applicable CPI us to provide appropriate and consistent files yearly. data after the MPFS and OPPS/ASC payment for designated new procedures Response: We appreciate the request proposed rules are published, we were that are not yet reflected in our claims and will consider revising the content of not able to include the actual updated data. Similar to pass-through payments, the ‘‘Drug Blood Brachy Cost statistics’’ furnishing fee in the proposed rules. an assignment to a New Technology file to include data on HCPCS code Therefore, in accordance with our APC is temporary; that is, we retain a Q9969 for future rulemaking. In the policy, as finalized in the CY 2008 service within a New Technology APC interim, claims data on HCPCS code OPPS/ASC final rule with comment until we acquire sufficient data to assign Q9969 are available for purchase in the period (72 FR 66765), we proposed to it to a clinically appropriate APC group. claims data sets released with announce the actual figure for the C. Excluded OPPS Services and publication of this final rule with percent change in the applicable CPI Hospitals comment period. and the updated furnishing fee After consideration of the public calculated based on that figure through Section 1833(t)(1)(B)(i) of the Act comments we received, we are applicable program instructions and authorizes the Secretary to designate the finalizing our proposal, without posting on the CMS Web site at: http:// hospital outpatient services that are modification, to continue the policy of www.cms.gov/Medicare/Medicare-Fee- paid under the OPPS. While most providing an additional $10 payment for for-Service-Part-B-Drugs/ hospital outpatient services are payable radioisotopes produced by non-HEU McrPartBDrugAvgSalesPrice/ under the OPPS, section sources for CY 2018, which will be the index.html. 1833(t)(1)(B)(iv) of the Act excludes sixth year in which this policy is in The OPPS rate is an unadjusted payment for ambulance, physical and effect in the OPPS. We will continue to national payment amount that includes occupational therapy, and speech- reassess this policy annually, consistent the Medicare payment and the language pathology services, for which with the original policy in the CY 2013 beneficiary copayment. This rate is payment is made under a fee schedule. OPPS/ASC final rule with comment divided into a labor-related amount and It also excludes screening period (77 FR 68319). a nonlabor-related amount. The labor- mammography, diagnostic related amount is adjusted for area wage mammography, and effective January 1, 5. Payment for Blood Clotting Factors differences using the hospital inpatient 2011, an annual wellness visit providing For CY 2017, we provided payment wage index value for the locality in personalized prevention plan services. for blood clotting factors under the same which the hospital or CMHC is located. The Secretary exercises the authority methodology as other nonpass-through All services and items within an APC granted under the statute to also exclude separately payable drugs and biologicals group are comparable clinically and from the OPPS certain services that are under the OPPS and continued paying with respect to resource use (section paid under fee schedules or other an updated furnishing fee (81 FR 1833(t)(2)(B) of the Act). In accordance payment systems. Such excluded 79676). That is, for CY 2017, we with section 1833(t)(2) of the Act, services include, for example, the provided payment for blood clotting subject to certain exceptions, items and professional services of physicians and factors under the OPPS at ASP+6 services within an APC group cannot be nonphysician practitioners paid under percent, plus an additional payment for considered comparable with respect to the Medicare Physician Fee Schedule the furnishing fee. We note that when the use of resources if the highest (MPFS); certain laboratory services paid blood clotting factors are provided in median cost (or mean cost, if elected by under the Clinical Laboratory Fee physicians’ offices under Medicare Part the Secretary) for an item or service in Schedule (CLFS); services for B and in other Medicare settings, a the APC group is more than 2 times beneficiaries with end-stage renal furnishing fee is also applied to the greater than the lowest median cost (or disease (ESRD) that are paid under the payment. The CY 2017 updated mean cost, if elected by the Secretary) ESRD prospective payment system; and furnishing fee was $0.209 per unit. for an item or service within the same services and procedures that require an In the CY 2018 OPPS/ASC proposed APC group (referred to as the ‘‘2 times inpatient stay that are paid under the rule (82 FR 33631), for CY 2018, we rule’’). In implementing this provision, hospital IPPS. In addition, section proposed to pay for blood clotting we generally use the cost of the item or 1833(t)(1)(B)(v) of the Act does not factors at ASP+6 percent, consistent service assigned to an APC group. include applicable items and services with our proposed payment policy for For new technology items and (as defined in subparagraph (A) of other nonpass-through, separately services, special payments under the paragraph (21)) that are furnished on or payable drugs and biologicals, and to OPPS may be made in one of two ways. after January 1, 2017 by an off-campus
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outpatient department of a provider (as Panel on Ambulatory Payment November 21, 2016, for a 2-year period defined in subparagraph (B) of Classification Groups (APC Panel) to (81 FR 94378). paragraph (21). We set forth the services fulfill this requirement. In CY 2011, The current Panel membership and that are excluded from payment under based on section 222 of the PHS Act other information pertaining to the the OPPS in regulations at 42 CFR which gives discretionary authority to Panel, including its charter, Federal 419.22. the Secretary to convene advisory Register notices, membership, meeting Under § 419.20(b) of the regulations, councils and committees, the Secretary dates, agenda topics, and meeting we specify the types of hospitals that are expanded the panel’s scope to include reports, can be viewed on the CMS Web excluded from payment under the the supervision of hospital outpatient site at: https://www.cms.gov/ OPPS. These excluded hospitals therapeutic services in addition to the Regulations-and-Guidance/Guidance/ include: APC groups and weights. To reflect this FACA/AdvisoryPanelonAmbulatory • Critical access hospitals (CAHs); new role of the panel, the Secretary PaymentClassificationGroups.html. • Hospitals located in Maryland and changed the panel’s name to the paid under the Maryland All-Payer Advisory Panel on Hospital Outpatient 3. Panel Meetings and Organizational Model; Payment (the HOP Panel or the Panel). Structure • Hospitals located outside of the 50 The HOP Panel is not restricted to using The Panel has held multiple meetings, States, the District of Columbia, and data compiled by CMS, and in with the last meeting taking place on Puerto Rico; and conducting its review, it may use data August 21, 2017. Prior to each meeting, • Indian Health Service (IHS) collected or developed by organizations we publish a notice in the Federal hospitals. outside the Department. Register to announce the meeting and, D. Prior Rulemaking 2. Establishment of the Panel when necessary, to solicit nominations for Panel membership, to announce new On April 7, 2000, we published in the On November 21, 2000, the Secretary members and to announce any other Federal Register a final rule with signed the initial charter establishing changes of which the public should be comment period (65 FR 18434) to the Panel, and at that time named the aware. Beginning in CY 2017, we have implement a prospective payment APC Panel. This expert panel is transitioned to one meeting per year (81 system for hospital outpatient services. composed of appropriate representatives FR 31941). Further information on the The hospital OPPS was first of providers (currently employed full- 2017 summer meeting can be found in implemented for services furnished on time, not as consultants, in their the meeting notice titled ‘‘Medicare or after August 1, 2000. Section respective areas of expertise), reviews Program: Announcement of the 1833(t)(9)(A) of the Act requires the clinical data, and advises CMS about the Advisory Panel on Hospital Outpatient Secretary to review certain components clinical integrity of the APC groups and Payment (the Panel) Meeting on August of the OPPS, not less often than their payment weights. Since CY 2012, 21–22, 2017’’ (82 FR 24128). annually, and to revise the groups, the Panel also is charged with advising In addition, the Panel has established relative payment weights, and other the Secretary on the appropriate level of an operational structure that, in part, adjustments that take into account supervision for individual hospital currently includes the use of three changes in medical practices, changes in outpatient therapeutic services. The subcommittees to facilitate its required technologies, and the addition of new Panel is technical in nature, and it is review process. The three current services, new cost data, and other governed by the provisions of the subcommittees include the following: relevant information and factors. Federal Advisory Committee Act • APC Groups and Status Indicator Since initially implementing the (FACA). The current charter specifies, Assignments Subcommittee, which OPPS, we have published final rules in among other requirements, that the advises the Panel on the appropriate the Federal Register annually to Panel— • status indicators to be assigned to implement statutory requirements and May advise on the clinical integrity HCPCS codes, including but not limited changes arising from our continuing of Ambulatory Payment Classification to whether a HCPCS code or a category experience with this system. These rules (APC) groups and their associated of codes should be packaged or can be viewed on the CMS Web site at: weights; separately paid, as well as the • May advise on the appropriate https://www.cms.gov/Medicare/ appropriate APC assignment of HCPCS supervision level for hospital outpatient Medicare-Fee-for-Service-Payment/ codes regarding services for which HospitalOutpatientPPS/Hospital- services; • Continues to be technical in nature; separate payment is made; Outpatient-Regulations-and- • • Data Subcommittee, which is Notices.html. Is governed by the provisions of the FACA; responsible for studying the data issues E. Advisory Panel on Hospital • Has a Designated Federal Official confronting the Panel and for Outpatient Payment (the HOP Panel or (DFO); and recommending options for resolving the Panel) • Is chaired by a Federal Official them; and designated by the Secretary. • Visits and Observation 1. Authority of the Panel The Panel’s charter was amended on Subcommittee, which reviews and Section 1833(t)(9)(A) of the Act, as November 15, 2011, renaming the Panel makes recommendations to the Panel on amended by section 201(h) of Public and expanding the Panel’s authority to all technical issues pertaining to Law 106–113, and redesignated by include supervision of hospital observation services and hospital section 202(a)(2) of Public Law 106–113, outpatient therapeutic services and to outpatient visits paid under the OPPS. requires that we consult with an add critical access hospital (CAH) Each of these subcommittees was external advisory panel of experts to representation to its membership. The established by a majority vote from the annually review the clinical integrity of Panel’s charter was also amended on full Panel during a scheduled Panel the payment groups and their weights November 6, 2014 (80 FR 23009), and meeting, and the Panel recommended at under the OPPS. In CY 2000, based on the number of members was revised the August 21, 2017 meeting that the section 1833(t)(9)(A) of the Act, the from up to 19 to up to 15 members. The subcommittees continue. We accepted Secretary established the Advisory Panel’s current charter was approved on this recommendation.
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In addition, discussions of the other ASC final rule with comment period available data to construct a database for recommendations made by the Panel at that appeared in the Federal Register on calculating APC group weights. the August 21, 2017 Panel meeting are November 14, 2016 (81 FR 79562), some For the purpose of recalibrating the included in the sections of this final of which contained comments on the APC relative payment weights for CY rule with comment period that are interim APC assignments and/or status 2018, we began with approximately 163 specific to each recommendation. For indicators of new or replacement Level million final action claims (claims for discussions of earlier Panel meetings II HCPCS codes (identified with which all disputes and adjustments and recommendations, we refer readers comment indicator ‘‘NI’’ in OPPS have been resolved and payment has to previously published OPPS/ASC Addendum B, ASC Addendum AA, and been made) for HOPD services furnished proposed and final rules, the CMS Web ASC Addendum BB to that final rule), on or after January 1, 2016, and before site mentioned earlier in this section, the potential limitation on clinical January 1, 2017, before applying our and the FACA database at http:// service line expansion or volume of exclusionary criteria and other facadatabase.gov. service increases by nonexcepted off- methodological adjustments. After the We note that we received some public campus provider-based departments, application of those data processing comments on the CY 2018 OPPS/ASC and the Medicare Physician Fee changes, we used approximately 86 proposed rule related to the HOP Panel Schedule (MPFS) payment rates for million final action claims to develop meeting presentations, which we nonexcepted items and services the CY 2018 OPPS payment weights. address below. furnished and billed by nonexcepted For exact numbers of claims used and Comment: One commenter supported off-campus provider-based departments additional details on the claims CMS’ extension of the HOP Panel of hospitals. Summaries of the public accounting process, we refer readers to meeting presentation submission comments are set forth in the CY 2018 the claims accounting narrative under deadline when there is a truncated proposed rule and this final rule with supporting documentation for this CY submittal timeframe due to delayed comment period under the appropriate 2018 OPPS/ASC final rule with publication of the OPPS/ASC proposed subject matter headings. Summaries of comment period on the CMS Web site rule. However, to avoid the need to public comments on the MPFS payment at: http://www.cms.gov/Medicare/ modify the submission deadline in the rates for nonexcepted items and services Medicare-Fee-for-Service-Payment/ future, the commenter suggested that are set forth in the CY 2018 MPFS final HospitalOutpatientPPS/index.html. CMS revise the submission deadline in rule with comment period. Addendum N to this final rule with the Federal Register notice from a firm comment period (which is available via II. Updates Affecting OPPS Payments date to a fluid 21 days from the the Internet on the CMS Web site) proposed rule display date to avoid this A. Recalibration of APC Relative includes the list of bypass codes for CY deadline issue in the future. Payment Weights 2018. The list of bypass codes contains Response: We appreciate the codes that were reported on claims for 1. Database Construction commenter’s request to modify the HOP services in CY 2016 and, therefore, Panel meeting submission deadline a. Database Source and Methodology includes codes that were in effect in CY format. However, frequency, timing, and 2016 and used for billing, but were presentation deadlines are outside the Section 1833(t)(9)(A) of the Act requires that the Secretary review not deleted for CY 2017. We retained these scope of the proposed rule and are deleted bypass codes on the CY 2018 generally announced through either a less often than annually and revise the relative payment weights for APCs. In bypass list because these codes existed separate Federal Register notice or in CY 2016 and were covered OPD subregulatory channel such as the CMS the April 7, 2000 OPPS final rule with comment period (65 FR 18482), we services in that period, and CY 2016 Web site, or both. claims data are used to calculate CY Comment: One commenter requested explained in detail how we calculated 2018 payment rates. Keeping these that CMS reinstate the winter Panel the relative payment weights that were deleted bypass codes on the bypass list meetings as part of a multifaceted implemented on August 1, 2000 for each potentially allows us to create more process that would allow for multiple APC group. ‘‘pseudo’’ single procedure claims for proposal refinements with Panel input In the CY 2018 OPPS/ASC proposed ratesetting purposes. ‘‘Overlap bypass prior to finalization of a policy. The rule (82 FR 33568), for CY 2018, we codes’’ that are members of the multiple commenter also suggested that CMS use proposed to recalibrate the APC relative imaging composite APCs are identified this winter meeting as a vehicle to allow payment weights for services furnished by asterisks (*) in the third column of stakeholders to review and discuss on or after January 1, 2018, and before Addendum N to this final rule with updated cost data for HCPCS codes and January 1, 2019 (CY 2018), using the comment period. HCPCS codes that we APCs prior to the release of the data in same basic methodology that we are adding for CY 2018 are identified by the proposed rule. described in the CY 2017 OPPS/ASC asterisks (*) in the fourth column of Response: We appreciate the final rule with comment period (81 FR Addendum N. commenter’s request to modify the 79574 through 79595). For this final rule Table 1 below contains the list of Panel meeting processes. However, the with comment period, for CY 2018, we codes that we are removing from the CY frequency of Panel meetings is outside recalibrated the APC relative payment 2018 bypass list. the scope of the proposed rule; meetings weights for services furnished on or are generally announced through either after January 1, 2018, and before January TABLE 1—HCPCS CODES REMOVED a separate Federal Register notice or a 1, 2019 (CY 2018), using the same basic subregulatory channel such as the CMS methodology that we described in the FROM THE CY 2018 BYPASS LIST Web site, or both. CY 2017 OPPS/ASC final rule with comment period, using updated CY HCPCS code HCPCS short descriptor F. Public Comments Received on the CY 2016 claims data. That is, we recalibrate 2017 OPPS/ASC Final Rule With the relative payment weights for each Comment Period 77305 Teletx isodose plan simple. APC based on claims and cost report 77310 Teletx isodose plan intermed. We received 39 timely pieces of data for hospital outpatient department 77315 Teletx isodose plan complex. correspondence on the CY 2017 OPPS/ (HOPD) services, using the most recent 77327 Brachytx isodose calc intern.
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TABLE 1—HCPCS CODES REMOVED the hospital-specific CCR to the alternative allocation methods, ‘‘direct FROM THE CY 2018 BYPASS LIST— hospital’s charges at the most detailed assignment’’ or ‘‘dollar value,’’ as a Continued level possible, based on a revenue code- more accurate methodology for directly to-cost center crosswalk that contains a assigning equipment costs, industry HCPCS hierarchy of CCRs used to estimate costs analysis suggested that approximately code HCPCS short descriptor from charges for each revenue code. only half of the reported cost centers for That crosswalk is available for review CT scans and MRIs rely on these 90801 Psy dx interview. and continuous comment on the CMS preferred methodologies. In response to 90802 Intac psy dx interview. Web site at: http://www.cms.gov/ concerns from commenters, we finalized 90804 Psytx office 20–30 min. 90805 Psytx off 20–30 min w/e&m. Medicare/Medicare-Fee-for-Service- a policy for the CY 2014 OPPS to 90806 Psytx off 45–50 min. Payment/HospitalOutpatientPPS/ remove claims from providers that use 90807 Psytx off 45–50 min w/e&m. index.html. a cost allocation method of ‘‘square 90808 Psytx office 75–80 min. To ensure the completeness of the feet’’ to calculate CCRs used to estimate 90809 Psytx off 75–80 w/e&m. revenue code-to-cost center crosswalk, costs associated with the CT and MRI 90810 Intac psytx off 20–30 min. we reviewed changes to the list of APCs (78 FR 74847). Further, we 90811 Intac psytx 20–40 w/e&m. revenue codes for CY 2016 (the year of finalized a transitional policy to 90812 Intac psytx off 45–50 min. claims data we used to calculate the CY estimate imaging APC relative payment 90857 Intac group psytx. 2018 OPPS payment rates) and found 90862 Medication management. weights using only CT and MRI cost 95115 Immunotherapy one injection. that the National Uniform Billing data from providers that do not use 95117 Immunotherapy injections. Committee (NUBC) did not add any new ‘‘square feet’’ as the cost allocation 95144 Antigen therapy services. revenue codes to the NUBC 2016 Data statistic. We provided that this finalized 95147 Antigen therapy services. Specifications Manual. policy would sunset in 4 years to 95165 Antigen therapy services. In accordance with our longstanding provide a sufficient time for hospitals to 96402 Chemo hormon antineopl sq/im. policy, we calculate CCRs for the 99201 Office/outpatient visit new. transition to a more accurate cost standard and nonstandard cost centers allocation method and for the related 99202 Office/outpatient visit new. accepted by the electronic cost report 99203 Office/outpatient visit new. data to be available for ratesetting 99204 Office/outpatient visit new. database. In general, the most detailed purposes (78 FR 74847). Therefore, 99205 Office/outpatient visit new. level at which we calculate CCRs is the beginning CY 2018, with the sunset of 99212 Office/outpatient visit est. hospital-specific departmental level. For the transition policy, we will estimate 99213 Office/outpatient visit est. a discussion of the hospital-specific the imaging APC relative payment 99214 Office/outpatient visit est. overall ancillary CCR calculation, we weight using cost data from all C1300 Hyperbaric oxygen. refer readers to the CY 2007 OPPS/ASC G0340 Robt lin-radsurg fractx 2–5. providers, regardless of the cost final rule with comment period (71 FR allocation statistic employed. G9141 Influenza A H1N1, admin w cou. 67983 through 67985). The calculation M0064 Visit for drug monitoring. of blood costs is a longstanding As we discussed in the CY 2018 exception (since the CY 2005 OPPS) to OPPS/ASC proposed rule (82 FR 33570), b. Calculation and Use of Cost-to-Charge this general methodology for calculation some stakeholders have raised concerns Ratios (CCRs) of CCRs used for converting charges to regarding using claims from all For CY 2018, in this CY 2018 OPPS/ costs on each claim. This exception is providers to calculate CT and MRI ASC final rule with comment period, as discussed in detail in the CY 2007 CCRs, regardless of the cost allocations we proposed, we are continuing to use OPPS/ASC final rule with comment statistic employed (78 FR 74840 through the hospital-specific overall ancillary period and discussed further in section 74847). Stakeholders noted that and departmental cost-to-charge ratios II.A.2.a.(1) of this final rule with providers continue to use the ‘‘square (CCRs) to convert charges to estimated comment period. feet’’ cost allocation method and that costs through application of a revenue In the CY 2014 OPPS/ASC final rule including claims from such providers code-to-cost center crosswalk. To with comment period (78 FR 74840 would cause significant reductions in calculate the APC costs on which the through 74847), we finalized our policy imaging APC payment rates. CY 2018 APC payment rates are based, of creating new cost centers and distinct Table 2 below demonstrates the we calculated hospital-specific overall CCRs for implantable devices, MRIs, CT relative effect on imaging APC payments ancillary CCRs and hospital-specific scans, and cardiac catheterization. after removing cost data for providers departmental CCRs for each hospital for However, in response to the CY 2014 that report CT and MRI standard cost which we had CY 2016 claims data by OPPS/ASC proposed rule, commenters centers using ‘‘square feet’’ as the cost comparing these claims data to the most reported that some hospitals currently allocation method by extracting HCRIS recently available hospital cost reports, use an imprecise ‘‘square feet’’ data on Worksheet B–1. Table 3 below which, in most cases, are from CY 2015. allocation methodology for the costs of provides statistical values based on the For the final CY 2018 OPPS payment large moveable equipment like CT scan CT and MRI standard cost center CCRs rates, we used the set of claims and MRI machines. They indicated that using the different cost allocation processed during CY 2016. We applied while CMS recommended using two methods.
TABLE 2—PERCENTAGE CHANGE IN ESTIMATE COST FOR CT AND MRI APCS WHEN EXCLUDING CLAIMS FROM PROVIDER USING ‘‘SQUARE FEET’’ AS THE COST ALLOCATION METHOD
Percentage APC APC descriptor change
5521 ...... Level 1 Imaging without Contrast ...... ¥3.8 5522 ...... Level 2 Imaging without Contrast ...... 5.3 5523 ...... Level 3 Imaging without Contrast ...... 6.3 5524 ...... Level 4 Imaging without Contrast ...... 5.0
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TABLE 2—PERCENTAGE CHANGE IN ESTIMATE COST FOR CT AND MRI APCS WHEN EXCLUDING CLAIMS FROM PROVIDER USING ‘‘SQUARE FEET’’ AS THE COST ALLOCATION METHOD—Continued
Percentage APC APC descriptor change
5571 ...... Level 1 Imaging with Contrast ...... 9.0 5572 ...... Level 2 Imaging with Contrast ...... 7.0 5573 ...... Level 3 Imaging with Contrast ...... 2.1 8005 ...... CT and CTA without Contrast Composite ...... 14.4 8006 ...... CT and CTA with Contrast Composite ...... 11.9 8007 ...... MRI and MRA without Contrast Composite ...... 7.2 8008 ...... MRI and MRA with Contrast Composite ...... 7.5
TABLE 3—CCR STATISTICAL VALUES BASED ON USE OF DIFFERENT COST ALLOCATION METHODS
CT MRI Cost allocation method Median CCR Mean CCR Median CCR Mean CCR
All Providers ...... 0.0387 0.0538 0.0795 0.1059 Square Feet Only ...... 0.0317 0.0488 0.0717 0.0968 Direct Assign ...... 0.0557 0.0650 0.1032 0.1222 Dollar Value ...... 0.0457 0.0603 0.0890 0.1178 Direct Assign and Dollar Value ...... 0.0457 0.0603 0.0893 0.1175
Our analysis showed that since the remove claims from providers that use monitor cost reporting practices with CY 2014 OPPS in which we established a cost allocation method of ‘‘square respect to CT scan and MRI cost centers the transition policy, the number of feet’’ to calculate CT and MRI CCRs in as well as trends in CT and MRI CCRs. valid MRI CCRs has increased by 17.5 subsequent calendar years. After consideration of the public percent to 2,177 providers and the Response: We thank the commenters comments we received, we are number of valid CT CCRs has increased for their support. As we discussed in the finalizing our proposal to extend our by 15.1 percent to 2,251 providers. CY 2018 OPPS/ASC proposed rule (82 transition policy for 1 additional year However, in the proposed rule, we FR 33570), our analysis shows that the and continue to remove claims from noted that, as shown in Table 2 above, number of valid MRI and CT CCRs has providers that use a cost allocation nearly all imaging APCs would see an increased since we established the method of ‘‘square feet’’ to calculate CT increase in payment rates for CY 2018 transition policy. We believe extending and MRI CCRs for the CY 2018 OPPS. our transition policy for 1 additional if claims from providers that report 2. Data Development Process and year will provide hospitals adequate ‘‘square feet’’ cost allocation method Calculation of Costs Used for Ratesetting were removed. This can be attributed to time to implement a more accurate cost the generally lower CCR values from allocation method for the costs of large In this section of this final rule with providers that use a cost allocation moveable equipment like CT scan and comment period, we discuss the use of method of ‘‘square feet’’ as shown in MRI machines. claims to calculate the OPPS payment Table 3 above. We stated in the Comment: Some commenters rates for CY 2018. The Hospital OPPS proposed rule that we believe that the recommended that CMS discontinue the page on the CMS Web site on which this imaging CCRs that we have are use of CT and MRI cost centers for final rule with comment period is appropriate for ratesetting. However, in developing CT and MRI CCRs. One posted (http://www.cms.gov/Medicare/ response to provider concerns and to commenter believed that creating Medicare-Fee-for-Service-Payment/ provide added flexibility for hospitals to separate CT and MRI cost centers has HospitalOutpatientPPS/index.html) improve their cost allocation methods, resulted in a decline in geometric means provides an accounting of claims used we proposed to extend the transition for imaging APCs which can be in the development of the payment policy an additional year, for the CY attributed to costs being dropped out rates. That accounting provides 2018 OPPS. and changes in hospital charging additional detail regarding the number For the CY 2018 OPPS, we proposed practices. of claims derived at each stage of the to continue to remove claims from Response: We are not convinced that process. In addition, below in this providers that use a cost allocation the change in CT and MRI CCRs over section we discuss the file of claims that method of ‘‘square feet’’ to calculate the previous years is a result of costs not comprises the data set that is available CCRs used to estimate costs with the CT being reported accurately. The standard upon payment of an administrative fee and MRI APCs identified in Table 2 cost centers for CT scans and MRIs have under a CMS data use agreement. The above. Beginning in CY 2019, we would been in effect since cost reporting CMS Web site, http://www.cms.gov/ estimate the imaging APC relative periods beginning on or after May 1, Medicare/Medicare-Fee-for-Service- payment weights using cost data from 2010, on the revised Medicare cost Payment/HospitalOutpatientPPS/ all providers, regardless of the cost report Form CMS–2552–10. Therefore, index.html, includes information about allocation statistic employed. the cost reports that we used to develop obtaining the ‘‘OPPS Limited Data Set,’’ Comment: Commenters supported the CY 2018 OPPS relative payment which now includes the additional CMS’ proposal to extend the transition weights were the fifth or sixth variables previously available only in policy an additional year, for the CY opportunity for hospitals to submit cost the OPPS Identifiable Data Set, 2018 OPPS. Several commenters reports with the CT and MRI cost including ICD–10–CM diagnosis codes recommended that CMS continue to centers. However, we will continue to and revenue code payment amounts.
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This file is derived from the CY 2016 processing, and storing blood and blood the relative estimated costs of these claims that were used to calculate the products, are made through the OPPS products for hospitals without blood payment rates for the CY 2018 OPPS. payments for specific blood product cost centers and, therefore, for these In the history of the OPPS, we have APCs. blood products in general. traditionally established the scaled In the CY 2018 OPPS/ASC proposed We note that, as discussed in section relative weights on which payments are rule (82 FR 33571), we proposed to II.A.2.e. of the CYs 2014 through 2017 based using APC median costs, which is continue to establish payment rates for OPPS/ASC final rules with comment a process described in the CY 2012 blood and blood products using our period (78 FR 74861 through 74910, 79 OPPS/ASC final rule with comment blood-specific CCR methodology, which FR 66798 through 66810, 80 FR 70325 period (76 FR 74188). However, as utilizes actual or simulated CCRs from through 70339, and 81 FR 79580 discussed in more detail in section the most recently available hospital cost through 79585, respectively), we II.A.2.f. of the CY 2013 OPPS/ASC final reports to convert hospital charges for defined a comprehensive APC (C–APC) rule with comment period (77 FR 68259 blood and blood products to costs. This as a classification for the provision of a through 68271), we finalized the use of methodology has been our standard primary service and all adjunctive geometric mean costs to calculate the ratesetting methodology for blood and services provided to support the relative weights on which the CY 2013 blood products since CY 2005. It was delivery of the primary service. Under OPPS payment rates were based. While developed in response to data analysis this policy, we include the costs of this policy changed the cost metric on indicating that there was a significant blood and blood products when which the relative payments are based, difference in CCRs for those hospitals calculating the overall costs of these C– the data process in general remained the with and without blood-specific cost APCs. In the CY 2018 OPPS/ASC same, under the methodologies that we centers, and past public comments proposed rule (82 FR 33571), we used to obtain appropriate claims data indicating that the former OPPS policy proposed to continue to apply the and accurate cost information in of defaulting to the overall hospital CCR blood-specific CCR methodology determining estimated service cost. For for hospitals not reporting a blood- described in this section when CY 2018, in this CY 2018 OPPS/ASC specific cost center often resulted in an calculating the costs of the blood and final rule with comment period, as we underestimation of the true hospital blood products that appear on claims proposed, we are continuing to use costs for blood and blood products. with services assigned to the C–APCs. geometric mean costs to calculate the Specifically, in order to address the Because the costs of blood and blood relative weights on which the CY 2018 differences in CCRs and to better reflect products would be reflected in the OPPS payment rates are based. hospitals’ costs, we proposed to overall costs of the C–APCs (and, as a We used the methodology described continue to simulate blood CCRs for result, in the proposed payment rates of in sections II.A.2.a. through II.A.2.c. of each hospital that does not report a the C–APCs), we proposed to not make this final rule with comment period to blood cost center by calculating the ratio separate payments for blood and blood calculate the costs we used to establish of the blood-specific CCRs to hospitals’ products when they appear on the same the relative payment weights used in overall CCRs for those hospitals that do claims as services assigned to the C– calculating the OPPS payment rates for report costs and charges for blood cost APCs (we refer readers to the CY 2015 CY 2018 shown in Addenda A and B to centers. We also proposed to apply this OPPS/ASC final rule with comment this final rule with comment period mean ratio to the overall CCRs of period (79 FR 66796)). (which are available via the Internet on hospitals not reporting costs and We also referred readers to the CMS Web site). We refer readers to charges for blood cost centers on their Addendum B to the proposed rule section II.A.4. of this final rule with cost reports in order to simulate blood- (which is available via the Internet on comment period for a discussion of the specific CCRs for those hospitals. We the CMS Web site) for the proposed CY conversion of APC costs to scaled proposed to calculate the costs upon 2018 payment rates for blood and blood payment weights. which the proposed CY 2018 payment products (which are identified with For details of the claims process used rates for blood and blood products are status indicator ‘‘R’’). For a more in this final rule with comment period, based using the actual blood-specific detailed discussion of the blood-specific we refer readers to the claims CCR for hospitals that reported costs CCR methodology, we refer readers to accounting narrative under supporting and charges for a blood cost center and the CY 2005 OPPS proposed rule (69 FR documentation for this CY 2018 OPPS/ a hospital-specific, simulated blood- 50524 through 50525). For a full history ASC final rule with comment period on specific CCR for hospitals that did not of OPPS payment for blood and blood the CMS Web site at: http:// report costs and charges for a blood cost products, we refer readers to the CY www.cms.gov/Medicare/Medicare-Fee- center. 2008 OPPS/ASC final rule with for-Service-Payment/ We continue to believe that the comment period (72 FR 66807 through HospitalOutpatientPPS/index.html. hospital-specific, simulated blood- 66810). specific CCR methodology better We invited public comments on our a. Calculation of Single Procedure APC responds to the absence of a blood- proposals. Criteria-Based Costs specific CCR for a hospital than Comment: Several commenters (1) Blood and Blood Products alternative methodologies, such as continued to support using the blood- defaulting to the overall hospital CCR or specific CCR methodology to establish (a) Methodology applying an average blood-specific CCR payment rates for blood and blood Since the implementation of the OPPS across hospitals. Because this products, which utilizes actual or in August 2000, we have made separate methodology takes into account the simulated CCRs from the most recently payments for blood and blood products unique charging and cost accounting available hospital cost reports to convert through APCs rather than packaging structure of each hospital, we believe hospital charges for blood and blood payment for them into payments for the that it yields more accurate estimated products to costs. The commenters also procedures with which they are costs for these products. We continue to supported using a blood-specific APC administered. Hospital payments for the believe that this methodology in CY with a separate APC for each blood and costs of blood and blood products, as 2018 would result in costs for blood and blood product service code. The well as for the costs of collecting, blood products that appropriately reflect commenters viewed the blood-specific
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CCR methodology as the best current would contain the costs for the new priorities, and we will work with the methodology to report the costs of blood safety measures. commenters and other stakeholders to and blood products. Response: As stated earlier in this ensure that any future updates to the Response: We appreciate the section, the OPPS covers hospital HCPCS P-codes will support our goal of commenters’ support. payments for the costs of blood and maintaining the safety of the blood Comment: Several commenters blood products, as well as for the costs supply. expressed concerns about reduced of collecting, processing, and storing After consideration of the public payment for several blood and blood blood and blood products. The cost of comments we received, we are products HCPCS codes, including blood and blood products is determined finalizing our proposal, without HCPCS codes P9010 (Blood (whole), for using claims data and blood-specific modification, to establish payment rates transfusion, per unit), P9011 (Blood, CCRs from hospitals. To the extent that for blood and blood products using our split unit), P9012 (Cryoprecipitate, each compliance with blood safety measures blood-specific CCR methodology. unit), P9016 (Red blood cells, is included in hospital reporting of the Addendum B to this final rule with leukocytes reduced, each unit), P9023 cost of collecting, processing and storing comment period (which is available via (Plasma, pooled multiple donor, blood and blood products, these costs the Internet on the CMS Web site) solvent/detergent treated, frozen, each would be reflected in the hospital rates. contains the final CY 2018 payment unit), P9035 (Platelets, pheresis, It is not possible to estimate the rates for blood and blood products leukocytes reduced, each unit), P9043 potential costs of new safety measures (which are identified with status (Infusion, plasma protein fraction outside of claims data. indicator ‘‘R’’). (human), 5%, 50 ml), P9048 (Infusion, Comment: Several commenters plasma protein fraction (human), 5%, resubmitted the comments they made in (b) Pathogen-Reduced Platelets and 250 ml), P9055 (Platelets, leukocytes response to a solicitation for public Rapid Bacterial Testing for Platelets reduced, cmv-negative, apheresis/ comments in the CY 2017 OPPS/ASC In March 2016, the Food and Drug pheresis, each unit), and P9060 (Fresh proposed rule (81 FR 45617 through Administration (FDA) issued draft frozen plasma, donor retested, each 45618) and summarized in the CY 2017 guidance for blood collection unit). Commenters supported the higher OPPS/ASC final rule with comment establishments and transfusion services payment rates for several HCPCS codes, period (81 FR 79577) on the current set entitled ‘‘Bacterial Risk Control including HCPCS codes P9019 of active HCPCS P-codes that describe Strategies for Blood Collection (Platelets, each unit) and P9034 blood products regarding how the code Establishments and Transfusion (Platelets, pheresis, each unit). descriptors could be revised and Services to Enhance the Safety and Response: We used claims data from updated (if necessary) to reflect the Availability of Platelets for Transfusion’’ CY 2016 and the same blood-specific current blood products provided to (available at: https://www.fda.gov/ CCR methodology we used in previous hospital outpatients. downloads/BiologicsBloodVaccines/ years to calculate these proposed The commenters supported a GuidanceComplianceRegulatory payment rates and believe the changes thorough examination of the current set Information/Guidances/Blood/ in costs for the services mentioned by of HCPCS P-codes for blood products as UCM425952.pdf). This draft guidance these commenters are a result of normal a necessary undertaking because the recommended, among other things, the variations in the claims data. HCPCS P-codes were created several use of rapid bacterial testing devices Comment: Two commenters years ago. Several commenters secondary to testing using a culture- expressed concern that the proposed recommended that CMS convene a based bacterial detection device or the payment rate for HCPCS code P9070 stakeholder group that includes implementation of pathogen-reduction (Plasma, pooled multiple donor, representatives of hospitals, blood technology for platelets to adequately pathogen reduced, frozen, each unit) banks, the American Red Cross, and control the risk of bacterial does not accurately reflect the cost of others to discuss a framework to contamination of platelets. the blood product. systematically review and revise the In the CY 2016 OPPS/ASC final rule Response: HCPCS code P9070 was HCPCS P-codes for blood products. with comment period (80 FR 70322), we established on January 1, 2016, and for Commenters also suggested that CMS established HCPCS code P9072 CY 2016 and CY 2017, we linked the establish a ‘‘not otherwise classified (Platelets, pheresis, pathogen reduced, payment of HCPCS code P9070 to a (NOC)’’ code for blood products, which each unit). The CMS HCPCS Workgroup blood product, HCPCS code P9059 would allow hospitals to begin later revised HCPCS code P9072 to (Fresh frozen plasma between 8–24 immediately billing for a new blood include the use of pathogen-reduction hours of collection, each unit), that we product that is not described by a technology or rapid bacterial testing. believed would have a comparable cost specific HCPCS P-code. One commenter Specifically, the descriptor for this code to HCPCS code P9070. CY 2018 is the supported the use of broader was revised, effective January 1, 2017, to first year for which we have claims data descriptions for HCPCS P-codes when read as follows: HCPCS code P9072 that will allow us to directly determine more granular language is no longer (Platelets, pheresis, pathogen reduced or the cost of HCPCS code P9070. In this meaningful for differentiating between rapid bacterial tested, each unit). The case, the payment rate for HCPCS code different types of blood and blood payment rate for HCPCS code P9072 is P9070 in CY 2018 is lower than the CY products, and where the costs and based on a crosswalk to HCPCS code 2017 payment rate. However, we believe volume of the HCPCS P-codes are P9037 (Platelets, pheresis, leukocyte the CY 2018 payment rate is appropriate similar. Other commenters suggested reduced, irradiated, each unit). We refer because it is based on actual claims data specific modifications to the order, readers to the CY 2016 OPPS/ASC final for HCPCS code P9070 rather than for classification, and code descriptors of rule with comment period for a further HCPCS code P9059. the blood and blood product HCPCS P- discussion of crosswalks for pathogen- Comment: Commenters requested that codes. reduced blood products (80 FR 70323). CMS immediately include the cost of Response: We appreciate the As discussed in the CY 2018 OPPS/ newly implemented FDA blood safety commenters’ detailed responses. The ASC proposed rule (82 FR 33571 and measures for blood and blood products safety of the nation’s blood supply 33572), after the release of the CY 2017 prior to receiving claims data that continues to be among the highest OPPS/ASC final rule with comment
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period, several blood and blood product CCR methodology, which utilizes actual proposed rule (82 FR 33571 and 33572), stakeholders expressed concerns about or simulated CCRs from the most we proposed for CY 2018 to determine the revised code descriptor for HCPCS recently available hospital cost reports the payment rate for HCPCS code Q9988 code P9072. The stakeholders believed to convert hospital charges for blood (the successor code to HCPCS code that the revision to HCPCS code P9072 and blood products to costs. Because P9072) by continuing to use the to describe both pathogen reduction and HCPCS code P9072 was new for CY payment rate that has been crosswalked rapid bacterial testing was an 2016, there were no claims data from HCPCS code P9037 of $647.12. inappropriate code descriptor. They available on the charges and costs for In the CY 2018 OPPS/ASC proposed stated that separate coding is needed to this blood product upon which to apply rule, we solicited public comments on describe each service because each our blood-specific CCR methodology. the proposed APC and status indicator service is distinct. The stakeholders also Therefore, we established an interim assignments for HCPCS codes Q9987 noted that the code descriptor for payment rates for this HCPCS code and Q9988 for the CY 2018 OPPS HCPCS code P9072 results in hospitals based on a crosswalk to existing blood update. The proposed payment rates for receiving the same payment rate for product HCPCS code P9037, which we HCPCS codes Q9987 and Q9988 were platelets undergoing rapid bacterial believed provided the best proxy for the included in Addendum B to the testing that the hospitals receive for costs of the new blood product. In proposed rule (which is available via platelets treated with pathogen addition, we stated that once we had the Internet on the CMS Web site). reduction technology, despite the fact claims data for HCPCS code P9072, we Comment: Commenters expressed that pathogen reduction is significantly would calculate its payment rate using their appreciation to CMS for working more expensive than rapid bacterial the claims data that should be available collaboratively with the American Red testing. for the code beginning in CY 2018, Cross and other stakeholders in the After review of the concerns which is our practice for other blood blood banking community to respond to expressed by the blood and blood product HCPCS codes for which claims their concerns about HCPCS code product stakeholders, the CMS HCPCS data have been available for 2 years. P9072. The commenters supported the Workgroup deactivated HCPCS code We stated in the proposed rule that, actions of CMS to deactivate HCPCS P9072 for Medicare reporting and although our standard practice for new code P9072 and replace it with HCPCS replaced the code with two new HCPCS codes involves using claims data to set codes Q9987 and Q9988 to have coding codes effective July 1, 2017. payment rates once claims data become options that more accurately reflect Specifically, effective July 1, 2017, available, we are concerned that there available technologies. The commenters HCPCS code Q9988 (Platelets, pheresis, may have been confusion among the also appreciated that separate payment pathogen reduced, each unit) is used to provider community about the services for each code was established in the report the use of pathogen-reduction that HCPCS code P9072 described. That OPPS and is proposed to continue in CY technology and HCPCS code Q9987 is, as early as 2016, there were 2018. (Pathogen(s) test for platelets) is used to discussions about changing the Response: We appreciate the support report rapid bacterial testing or other descriptor for HCPCS code P9072 to for our actions in CY 2017 and our pathogen tests for platelets, instead of include the phrase ‘‘or rapid bacterial proposal for CY 2018. HCPCS code P9072. We note that tested’’, which is a much less costly Comment: One commenter requested HCPCS code Q9987 should be reported technology than pathogen reduction. In that the description of HCPCS code to describe the test used for the addition, as noted above, effective Q9987 (Pathogen(s) test for platelets) be detection of bacterial contamination in January 2017, the code descriptor for modified by adding the word platelets as well as any other test that HCPCS code P9072 was, in fact, ‘‘secondary’’ to clarify in the procedure may be used to detect pathogen changed to also describe rapid bacterial code descriptor that HCPCS code Q9987 contamination. HCPCS code Q9987 testing of platelets and, effective July 1, is intended to be used for secondary should not be used for reporting 2017, the descriptor for the temporary bacterial testing of platelets. donation testing for infectious agents successor code for HCPCS code P9072 Response: We believe the guidance such as viruses. The coding changes (that is, HCPCS code Q9988) was we have provided through the CY 2018 associated with these codes were changed again back to the original proposed rule (82 FR 33571 and 33572) published on the CMS HCPCS Quarterly descriptor for HCPCS code P9072 that and associated subregulatory guidance Update Web site, effective July 2017, at: was in place for 2016. (Pub. 100–04 Medicare Claims https://www.cms.gov/Medicare/Coding/ Based on the ongoing discussions Processing, Transmittal 3783, Change HCPCSReleaseCodeSets/HCPCS- involving changes to the original HCPCS Request 10122) are sufficient for Quarterly-Update.html. In addition, for code P9072 established in CY 2016, we providers to understand how to OPPS, we announced the new HCPCS believe that claims for pathogen reduced appropriately report HCPCS code codes that were effective July 1, 2017 platelets may potentially reflect certain Q9987. We do not agree with the through the July 2017 OPPS quarterly claims for rapid bacterial testing of suggestion to modify the descriptor of update Change Request (Transmittal platelets. The geometric mean costs HCPCS code Q9987, as we want the 3783, Change Request 10122, dated May based on submitted claims for HCPCS code to have the flexibility to be used 26, 2017). We note that, effective July 1, code P9072 based on available claims to report new tests that may be 2017, HCPCS code Q9988 is assigned to data from CY 2016 is $491.53, which is developed in the future that are APC 9536 (Pathogen Reduced Platelets), a 24-percent reduction from the CY designed to identify pathogen with a payment rate of $647.12, and 2017 payment rate of $647.12. Because contamination of platelets. HCPCS code Q9987 is assigned to New we believe that there may have been After consideration of the public Technology APC 1493, with a payment confusion related to ongoing comments we received, we are rate of $25.50. discussions about changes to the finalizing our CY 2018 proposal for In the CY 2016 OPPS/ASC final rule original code descriptor for HCPCS code reporting pathogen-reduced platelets with comment period (80 FR 70322 P9072, we believe it is appropriate to and rapid bacterial testing for platelets. through 70323), we reiterated that we continue to crosswalk the payment The only changes are to replace HCPCS calculate payment rates for blood and amount for at least 1 additional year. code Q9987 (Pathogen(s) test for blood products using our blood-specific Therefore, in the CY 2018 OPPS/ASC platelets) with HCPCS code P9100
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(Pathogen(s) test for platelets) and to Details of the replacement of HCPCS and P9073 can be found in Addendum replace HCPCS code Q9988 (Platelets, codes Q9987 and Q9988 with HCPCS B to this final rule with comment period pheresis, pathogen-reduced, each unit) codes P9100 and P9073, respectively, (which is available via the Internet on with HCPCS code P9073 (Platelets, are found in Table 4 below. The final the CMS Web site). pheresis, pathogen-reduced, each unit). payment rates for HCPCS codes P9100
TABLE 4—REPLACEMENT CODES FOR HCPCS CODES Q9987 AND Q9988 AS OF JANUARY 1, 2018
CY 2017 CY 2018 HCPCS HCPCS CY 2018 long descriptor Final CY Final CY code code 2018 SI 2018 APC
Q9987 ...... P9100 Pathogen(s) test for platelets ...... S 1493 Q9988 ...... P9073 Platelets, pheresis, pathogen-reduced, each unit ...... R 9536
(2) Brachytherapy Sources use to set the proposed payment rates assign status indicator ‘‘E2’’ (Items and Section 1833(t)(2)(H) of the Act for most other items and services that Services for Which Pricing Information mandates the creation of additional would be paid under the CY 2018 OPPS. and Claims Data Are Not Available) to groups of covered OPD services that We proposed to base the payment rates HCPCS code C2645 (Brachytherapy classify devices of brachytherapy for brachytherapy sources on the planar, palladium-103, per square consisting of a seed or seeds (or geometric mean unit costs for each millimeter) because this code was not radioactive source) (‘‘brachytherapy source, consistent with the methodology reported on CY 2016 claims. Therefore, sources’’) separately from other services that we proposed for other items and we are unable to calculate a proposed or groups of services. The statute services paid under the OPPS, as payment rate based on the general OPPS provides certain criteria for the discussed in section II.A.2. of the ratesetting methodology described additional groups. For the history of proposed rule. We also proposed to earlier. Although HCPCS code C2645 OPPS payment for brachytherapy continue the other payment policies for became effective January 1, 2016, and sources, we refer readers to prior OPPS brachytherapy sources that we finalized although we would expect that if a final rules, such as the CY 2012 OPPS/ and first implemented in the CY 2010 hospital furnished a brachytherapy ASC final rule with comment period (77 OPPS/ASC final rule with comment source described by this code in CY FR 68240 through 68241). As we have period (74 FR 60537). We proposed to 2016, HCPCS code C2645 should appear stated in prior OPPS updates, we pay for the stranded and nonstranded on the CY 2016 claims, there were no believe that adopting the general OPPS not otherwise specified (NOS) codes, CY 2016 claims reporting this code prospective payment methodology for HCPCS codes C2698 and C2699, at a available for the proposed rule. In brachytherapy sources is appropriate for rate equal to the lowest stranded or addition, unlike our policy for new a number of reasons (77 FR 68240). The nonstranded prospective payment rate brachytherapy sources HCPCS codes, general OPPS methodology uses costs for such sources, respectively, on a per we did not consider external data to based on claims data to set the relative source basis (as opposed to, for determine a proposed payment rate for payment weights for hospital outpatient example, a per mCi), which is based on HCPCS code C2645 for CY 2018. services. This payment methodology the policy we established in the CY Therefore, we proposed to assign status results in more consistent, predictable, 2008 OPPS/ASC final rule with indicator ‘‘E2’’ to HCPCS code C2645. and equitable payment amounts per comment period (72 FR 66785). We also In addition, we assigned status source across hospitals by averaging the proposed to continue the policy we first indicator ‘‘E2’’ to HCPCS code C2644 extremely high and low values, in implemented in the CY 2010 OPPS/ASC (Brachytherapy, cesium-131 chloride, contrast to payment based on hospitals’ final rule with comment period (74 FR per square millimeter) because this code charges adjusted to costs. We believe 60537) regarding payment for new was not reported on any CY 2015 claims that the OPPS methodology, as opposed brachytherapy sources for which we (that is, there were no Medicare claims to payment based on hospitals’ charges have no claims data, based on the same submitted by any hospitals in 2015 that adjusted to cost, also would provide reasons we discussed in the CY 2008 reported this HCPCS code). In our hospitals with incentives for efficiency OPPS/ASC final rule with comment review of CY 2016 claims (which are in the provision of brachytherapy period (72 FR 66786; which was used to set rates for CY 2018), we found services to Medicare beneficiaries. delayed until January 1, 2010 by section that one hospital submitted one claim Moreover, this approach is consistent 142 of Pub. L. 110–275). Specifically, reporting HCPCS code C2644. with our payment methodology for the this policy is intended to enable us to Therefore, we proposed to assign status vast majority of items and services paid assign new HCPCS codes for new indicator ‘‘U’’ to HCPCS code C2644. under the OPPS. We refer readers to the brachytherapy sources to their own We invited public comments on our CY 2016 OPPS/ASC final rule with APCs, with prospective payment rates proposals. comment period (80 FR 70323 through set based on our consideration of Comment: One commenter suggested 70325) for further discussion of the external data and other relevant that CMS set the CY 2018 APC payment history of OPPS payment for information regarding the expected rate for HCPCS code C2636 brachytherapy sources. costs of the sources to hospitals. (Brachytherapy linear, non-stranded, In the CY 2018 OPPS/ASC proposed The proposed CY 2018 payment rates palladium-103, per 1mm) at $26.99 per rule (82 FR 33572), for CY 2018, we for brachytherapy sources were millimeter. proposed to use the costs derived from included in Addendum B to the Response: As noted in past CY 2016 claims data to set the proposed proposed rule (which is available via rulemaking cycles and in the CY 2018 CY 2018 payment rates for the Internet on the CMS Web site) and OPPS/ASC proposed rule (82 FR 33572), brachytherapy sources because CY 2016 were identified with status indicator we believe that adopting the general is the same year of data we proposed to ‘‘U’’. For CY 2018, we proposed to OPPS prospective payment
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methodology for brachytherapy sources were inpatient cases. However, the the Internet on the CMS Web site) and is consistent with our payment commenter noted its expectation that are identified with status indicator ‘‘U’’. methodology for the vast majority of such source would begin to be used in We continue to invite hospitals and items and services paid under the OPPS. the hospital outpatient department other parties to submit Further, while we assign new HCPCS setting beginning approximately in mid- recommendations to us for new codes to codes for new brachytherapy sources to 2018. This commenter noted that the describe new brachytherapy sources. their own APCs, with prospective ‘‘E2’’ status indicator would effectively Such recommendations should be payment rates set based on our render the outpatient payment rate as $0 directed to the Division of Outpatient consideration of external data and other for CY 2018. The commenter supplied Care, Mail Stop C4–01–26, Centers for relevant information regarding the external invoices to support maintaining Medicare and Medicaid Services, 7500 expected costs of the sources to the current payment rate of $4.69 per Security Boulevard, Baltimore, MD hospitals, HCPCS code C2636 is neither mm2. 21244. We will continue to add new new nor lacks claim information. Response: We note that the CY 2008 brachytherapy source codes and HCPCS code C2636 became effective final rule with comment period descriptors to our systems for payment July 1, 2007. The final CY 2018 APC preamble language that the commenters on a quarterly basis. payment rate for HCPCS code C2636 is referenced to support their argument $27.08 based on data for the 8 claims we b. Comprehensive APCs (C–APCs) for that external data have been used in the CY 2018 received for the CY 2018 OPPS standard past was in reference to a brachytherapy ratesetting process and can be found in source for which there appeared to have (1) Background Addendum B to this final rule with been erroneous claims submitted since In the CY 2014 OPPS/ASC final rule comment period (which is available via the claims were from 2006, but the with comment period (78 FR 74861 the Internet on the CMS Web site). brachytherapy source did not come to through 74910), we finalized a Comment: Some commenters market until 2007. This is comprehensive payment policy that suggested that HCPCS code C2645 distinguishable from the situation with packages payment for adjunctive and (Brachytherapy, planar, palladium-103) HCPCS code C2645 which has been on had been incorrectly assigned status secondary items, services, and the market since August 29, 2014 and procedures into the most costly primary indicator ‘‘E2’’ (Items and Services for had a code effective date of January 1, Which Pricing Information and Claims procedure under the OPPS at the claim 2016. Nonetheless, as the commenters level. The policy was finalized in CY Data Are Not Available). These noted, there are no Medicare claims data commenters stated that CMS has 2014, but the effective date was delayed available at this time. While this considered external data and other until January 1, 2015, to allow brachytherapy source is no longer relevant information where no claims additional time for further analysis, ‘‘new,’’ the absence of even a single data exist for new HCPCS codes for new opportunity for public comment, and Medicare claim in the outpatient brachytherapy sources. For example, systems preparation. The hospital data leads us to agree with the commenters included the following comprehensive APC (C–APC) policy commenter that using an external source excerpt from the CY 2008 OPPS/ASC was implemented effective January 1, of data would be appropriate at this final rule with comment period 2015, with modifications and time. Accordingly, for CY 2018, we are regarding CMS’ policy with respect to clarifications in response to public assigning status indicator ‘‘U’’ to HCPCS establishing a payment rate for HCPCS comments received regarding specific code C2637 (Brachytherapy non- code C2645 and are using external data provisions of the C–APC policy (79 FR stranded, ytterbium-169, per source) for (invoice prices) and other relevant 66798 through 66810). which CMS lacked claims data: ‘‘if in information to establish the APC A C–APC is defined as a classification public comments to the proposed rule payment rate for HCPCS code C2645. for the provision of a primary service Specifically, we are setting the payment and all adjunctive services provided to or later in CYs 2007 or 2008, we would 2 receive relevant and reliable rate at $4.69 per mm , the same rate that support the delivery of the primary information on the hospital cost for was in effect for CYs 2016 and 2017. service. We established C–APCs as a ytterbium-169 and information that this After consideration of the public category broadly for OPPS payment and source is being marketed, we could comments we received, we are implemented 25 C–APCs beginning in establish a prospective payment rate for finalizing our proposal to assign status CY 2015 (79 FR 66809 through 66810). the source in the CY 2008 final rule indicator ‘‘U’’ to HCPCS code C2636 In the CY 2016 OPPS/ASC final rule with comment period or in a quarterly (Brachytherapy linear, non-stranded, with comment period (80 FR 70332), we OPPS update, respectively’’ (72 FR palladium-103, per 1mm) and assigning finalized 10 additional C–APCs to be 66786). an APC payment rate for HCPCS code paid under the existing C–APC payment In addition, commenters noted that, C2636 at $27.08 based on the 8 claims policy and added one additional level to for CY 2016 and CY 2017, HCPCS code we received for the CY 2018 OPPS both the Orthopedic Surgery and C2645 was assigned an OPPS status standard ratesetting process. We also are Vascular Procedures clinical families. In indicator of ‘‘U’’ (Brachytherapy finalizing our proposal to assign status the CY 2017 OPPS/ASC final rule with Sources, Paid under OPPS; separate indicator ‘‘U’’ to HCPCS code C2644 comment period (81 FR 79584 through APC payment) and a payment rate of (Brachytherapy, cesium-131 chloride, 79585), we finalized another 25 $4.69 per mm2 and that the payment per millicurie) and are modifying our C–APCs. rate was based upon external pricing proposal to assign status indicator ‘‘E2’’ Under this policy, we designate a data previously supplied by the to HCPCS code C2645 (Brachytherapy service described by a HCPCS code developer of the brachytherapy source planar, palladium-103, per square assigned to a C–APC as the primary described by HCPCS code C2645. The millimeter) and instead adopting a service when the service is identified by developer of the brachytherapy source status indicator of ‘‘U’’ for CY 2018. The OPPS status indicator ‘‘J1’’. When such noted that there were no outpatient final CY 2018 payment rates for a primary service is reported on a claims from CY 2016 for HCPCS code brachytherapy sources can be found in hospital outpatient claim, taking into C2645 because all of the cases in CY Addendum B to this final rule with consideration the few exceptions that 2016 that used the brachytherapy source comment period (which is available via are discussed below, we make payment
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for all other items and services reported characteristics of each procedure to not covered OPD services or that cannot on the hospital outpatient claim as establish clinical similarity within each by statute be paid for under the OPPS) being integral, ancillary, supportive, APC. to be deemed adjunctive services dependent, and adjunctive to the In the CY 2016 OPPS/ASC final rule representing components of a primary service (hereinafter collectively with comment period, we expanded the comprehensive service and resulting in referred to as ‘‘adjunctive services’’) and C–APC payment methodology to a single prospective payment for the representing components of a complete qualifying extended assessment and comprehensive service based on the comprehensive service (78 FR 74865 management encounters through the costs of all reported services on the and 79 FR 66799). Payments for ‘‘Comprehensive Observation Services’’ claim (80 FR 70333 through 70336). adjunctive services are packaged into C–APC (C–APC 8011). Services within Services included under the C–APC the payments for the primary services. this APC are assigned status indicator payment packaging policy, that is, This results in a single prospective ‘‘J2’’. Specifically, we make a payment services that are typically adjunctive to payment for each of the primary, through C–APC 8011 for a claim that: the primary service and provided during comprehensive services based on the • Does not contain a procedure the delivery of the comprehensive costs of all reported services at the claim described by a HCPCS code to which we service, include diagnostic procedures, level. have assigned status indicator ‘‘T’’ that laboratory tests, and other diagnostic Services excluded from the C–APC is reported with a date of service on the tests and treatments that assist in the policy under the OPPS include services same day or 1 day earlier than the date delivery of the primary procedure; visits that are not covered OPD services, of service associated with services and evaluations performed in services that cannot by statute be paid described by HCPCS code G0378; association with the procedure; for under the OPPS, and services that • Contains 8 or more units of services uncoded services and supplies used are required by statute to be separately described by HCPCS code G0378 during the service; durable medical paid. This includes certain (Observation services, per hour); equipment as well as prosthetic and mammography and ambulance services • Contains services provided on the orthotic items and supplies when that are not covered OPD services in same date of service or 1 day before the provided as part of the outpatient accordance with section date of service for HCPCS code G0378 service; and any other components 1833(t)(1)(B)(iv) of the Act; that are described by one of the reported by HCPCS codes that represent brachytherapy seeds, which also are following codes: HCPCS code G0379 services that are provided during the required by statute to receive separate (Direct referral of patient for hospital complete comprehensive service (78 FR payment under section 1833(t)(2)(H) of observation care) on the same date of 74865 and 79 FR 66800). the Act; pass-through payment drugs service as HCPCS code G0378; CPT code In addition, payment for hospital and devices, which also require separate 99281 (Emergency department visit for outpatient department services that are payment under section 1833(t)(6) of the the evaluation and management of a similar to therapy services and Act; self-administered drugs (SADs) that patient (Level 1)); CPT code 99282 delivered either by therapists or are not otherwise packaged as supplies (Emergency department visit for the nontherapists is included as part of the because they are not covered under evaluation and management of a patient payment for the packaged complete Medicare Part B under section (Level 2)); CPT code 99283 (Emergency comprehensive service. These services 1861(s)(2)(B) of the Act; and certain department visit for the evaluation and that are provided during the preventive services (78 FR 74865 and 79 management of a patient (Level 3)); CPT perioperative period are adjunctive FR 66800 through 66801). A list of code 99284 (Emergency department services and are deemed not to be services excluded from the C–APC visit for the evaluation and management therapy services as described in section policy is included in Addendum J to of a patient (Level 4)); CPT code 99285 1834(k) of the Act, regardless of whether this final rule with comment period (Emergency department visit for the the services are delivered by therapists (which is available via the Internet on evaluation and management of a patient or other nontherapist health care the CMS Web site). (Level 5)) or HCPCS code G0380 (Type workers. We have previously noted that The C–APC policy payment B emergency department visit (Level 1)); therapy services are those provided by methodology set forth in the CY 2014 HCPCS code G0381 (Type B emergency therapists under a plan of care in OPPS/ASC final rule with comment department visit (Level 2)); HCPCS code accordance with section 1835(a)(2)(C) period for the C–APCs and modified G0382 (Type B emergency department and section 1835(a)(2)(D) of the Act and and implemented beginning in CY 2015 visit (Level 3)); HCPCS code G0383 are paid for under section 1834(k) of the is summarized as follows (78 FR 74887 (Type B emergency department visit Act, subject to annual therapy caps as and 79 FR 66800): (Level 4)); HCPCS code G0384 (Type B applicable (78 FR 74867 and 79 FR Basic Methodology. As stated in the emergency department visit (Level 5)); 66800). However, certain other services CY 2015 OPPS/ASC final rule with CPT code 99291 (Critical care, similar to therapy services are comment period, we define the C–APC evaluation and management of the considered and paid for as hospital payment policy as including all covered critically ill or critically injured patient; outpatient department services. OPD services on a hospital outpatient first 30–74 minutes); or HCPCS code Payment for these nontherapy claim reporting a primary service that is G0463 (Hospital outpatient clinic visit outpatient department services that are assigned to status indicator ‘‘J1’’, for assessment and management of a reported with therapy codes and excluding services that are not covered patient); and provided with a comprehensive service OPD services or that cannot by statute • Does not contain services described is included in the payment for the be paid for under the OPPS. Services by a HCPCS code to which we have packaged complete comprehensive and procedures described by HCPCS assigned status indicator ‘‘J1’’. service. We note that these services, codes assigned to status indicator ‘‘J1’’ The assignment of status indicator even though they are reported with are assigned to C–APCs based on our ‘‘J2’’ to a specific combination of therapy codes, are hospital outpatient usual APC assignment methodology by services performed in combination with department services and not therapy evaluating the geometric mean costs of each other allows for all other OPPS services. Therefore, the requirement for the primary service claims to establish payable services and items reported on functional reporting under the resource similarity and the clinical the claim (excluding services that are regulations at 42 CFR 410.59(a)(4) and
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42 CFR 410.60(a)(4) does not apply. We our cost-based ranking of primary there are paired code combinations that refer readers to the July 2016 OPPS services. We then assign these multiple meet the complexity adjustment criteria. Change Request 9658 (Transmittal 3523) ‘‘J1’’ procedure claims to the C–APC to For a new HCPCS code, we determine for further instructions on reporting which the service designated as the initial C–APC assignment and these services in the context of a C–APC primary service is assigned. If the qualification for a complexity service. reported ‘‘J1’’ services on a claim map adjustment using the best available Items included in the packaged to different C–APCs, we designate the information, crosswalking the new payment provided in conjunction with ‘‘J1’’ service assigned to the C–APC with HCPCS code to a predecessor code(s) the primary service also include all the highest comprehensive geometric when appropriate. drugs, biologicals, and mean cost as the primary service for that Once we have determined that a radiopharmaceuticals, regardless of cost, claim. If the reported multiple ‘‘J1’’ particular code combination of ‘‘J1’’ except those drugs with pass-through services on a claim map to the same services (or combinations of ‘‘J1’’ payment status and SADs, unless they C–APC, we designate the most costly services reported in conjunction with function as packaged supplies (78 FR service (at the HCPCS code level) as the certain add-on codes) represents a 74868 through 74869 and 74909 and 79 primary service for that claim. This complex version of the primary service FR 66800). We refer readers to Section process results in initial assignments of because it is sufficiently costly, 50.2M, Chapter 15, of the Medicare claims for the primary services assigned frequent, and a subset of the primary Benefit Policy Manual for a description to status indicator ‘‘J1’’ to the most comprehensive service overall of our policy on SADs treated as appropriate C–APCs based on both according to the criteria described hospital outpatient supplies, including single and multiple procedure claims above, we promote the claim including lists of SADs that function as supplies reporting these services and clinical and the complex version of the primary and those that do not function as resource homogeneity. service as described by the code supplies. Complexity Adjustments. We use combination to the next higher cost We define each hospital outpatient complexity adjustments to provide C–APC within the clinical family, claim reporting a single unit of a single increased payment for certain unless the primary service is already primary service assigned to status comprehensive services. We apply a assigned to the highest cost APC within indicator ‘‘J1’’ as a single ‘‘J1’’ unit complexity adjustment by promoting the C–APC clinical family or assigned to procedure claim (78 FR 74871 and 79 qualifying paired ‘‘J1’’ service code the only C–APC in a clinical family. We FR 66801). Line item charges for combinations or paired code do not create new APCs with a services included on the C–APC claim combinations of ‘‘J1’’ services and comprehensive geometric mean cost are converted to line item costs, which certain add-on codes (as described that is higher than the highest geometric are then summed to develop the further below) from the originating mean cost (or only) C–APC in a clinical estimated APC costs. These claims are C–APC (the C–APC to which the family just to accommodate potential then assigned one unit of the service designated primary service is first complexity adjustments. Therefore, the with status indicator ‘‘J1’’ and later used assigned) to the next higher paying highest payment for any claim including to develop the geometric mean costs for C–APC in the same clinical family of a code combination for services the C–APC relative payment weights. C–APCs. We apply this type of assigned to a C–APC would be the (We note that we use the term complexity adjustment when the paired highest paying C–APC in the clinical ‘‘comprehensive’’ to describe the code combination represents a complex, family (79 FR 66802). geometric mean cost of a claim reporting costly form or version of the primary We package payment for all add-on ‘‘J1’’ service(s) or the geometric mean service according to the following codes into the payment for the C–APC. cost of a C–APC, inclusive of all of the criteria: However, certain primary service add- items and services included in the C– • Frequency of 25 or more claims on combinations may qualify for a APC service payment bundle.) Charges reporting the code combination complexity adjustment. As noted in the for services that would otherwise be (frequency threshold); and CY 2016 OPPS/ASC final rule with separately payable are added to the • Violation of the 2 times rule in the comment period (80 FR 70331), all add- charges for the primary service. This originating C–APC (cost threshold). on codes that can be appropriately process differs from our traditional cost These criteria identify paired code reported in combination with a base accounting methodology only in that all combinations that occur commonly and code that describes a primary ‘‘J1’’ such services on the claim are packaged exhibit materially greater resource service are evaluated for a complexity (except certain services as described requirements than the primary service. adjustment. above). We apply our standard data The CY 2017 OPPS/ASC final rule with To determine which combinations of trims, which exclude claims with comment period (81 FR 79582) included primary service codes reported in extremely high primary units or extreme a revision to the complexity adjustment conjunction with an add-on code may costs. eligibility criteria. Specifically, we qualify for a complexity adjustment for The comprehensive geometric mean finalized a policy to discontinue the CY 2018, in the CY 2018 OPPS/ASC costs are used to establish resource requirement that a code combination proposed rule (82 FR 33575), we similarity and, along with clinical (that qualifies for a complexity proposed to apply the frequency and similarity, dictate the assignment of the adjustment by satisfying the frequency cost criteria thresholds discussed above, primary services to the C–APCs. We and cost criteria thresholds described testing claims reporting one unit of a establish a ranking of each primary above) also not create a 2 times rule single primary service assigned to status service (single unit only) to be assigned violation in the higher level or receiving indicator ‘‘J1’’ and any number of units to status indicator ‘‘J1’’ according to its APC. of a single add-on code for the primary comprehensive geometric mean costs. After designating a single primary J1 service. If the frequency and cost For the minority of claims reporting service for a claim, we evaluate that criteria thresholds for a complexity more than one primary service assigned service in combination with each of the adjustment are met and reassignment to to status indicator ‘‘J1’’ or units thereof, other procedure codes reported on the the next higher cost APC in the clinical we identify one ‘‘J1’’ service as the claim assigned to status indicator ‘‘J1’’ family is appropriate (based on meeting primary service for the claim based on (or certain add-on codes) to determine if the criteria outlined above), we make a
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complexity adjustment for the code complexity adjustment (including Addendum J to the proposed rule combination; that is, we reassign the primary code and add-on code allowed stakeholders the opportunity to primary service code reported in combinations). Addendum J to the better assess the impact associated with conjunction with the add-on code to the proposed rule also contained summary the proposed reassignment of claims next higher cost C–APC within the same cost statistics for each of the paired code with each of the paired code clinical family of C–APCs. As combinations that describe a complex combinations eligible for a complexity previously stated, we package payment code combination that would qualify for adjustment. for add-on codes into the C–APC a complexity adjustment and were payment rate. If any add-on code proposed to be reassigned to the next Comment: Several commenters reported in conjunction with the ‘‘J1’’ higher cost C–APC within the clinical requested exceptions to the current primary service code does not qualify family. The combined statistics for all complexity adjustment criteria of 25 or for a complexity adjustment, payment proposed reassigned complex code more claims reporting the code for the add-on service continues to be combinations were represented by an combination (frequency) and a violation packaged into the payment for the alphanumeric code with the first 4 of the 2 times rule in the originating primary service and is not reassigned to digits of the designated primary service C–APC (cost) to allow claims with code the next higher cost C–APC. We listed followed by a letter. For example, the combinations that do not currently meet the complexity adjustments proposed proposed geometric mean cost listed in these criteria to be paid at the next for ‘‘J1’’ and add-on code combinations Addendum J for the code combination higher paying C–APC. The C–APC for CY 2018, along with all of the other described by complexity adjustment complexity adjustments requested by proposed complexity adjustments, in assignment 3320R, which is assigned to the commenters are listed in Table 5 Addendum J to the proposed rule C–APC 5224 (Level 4 Pacemaker and below. We did not propose for claims (which is available via the Internet on Similar Procedures), included all paired with these code combinations to receive the CMS Web site). code combinations that were proposed complexity adjustments because they Addendum J to the proposed rule to be reassigned to C–APC 5224 when failed to meet either the cost or included the cost statistics for each code CPT code 33208 is the primary code. frequency criteria. combination that would qualify for a Providing the information contained in
TABLE 5—C–APC COMPLEXITY ADJUSTMENTS REQUESTED BY THE COMMENTERS
Requested Primary APC complexity Primary ‘‘J1’’ HCPCS code Secondary ‘‘J1’’ HCPCS code assignment adjusted APC assignment
20983 (Ablation therapy for reduction or eradication of 22513 (Percutaneous vertebral augmentation, includ- 5114 5115 1 or more bone tumors (eg, metastasis including ing cavity creation (fracture reduction and bone bi- adjacent soft tissue when involved by tumor exten- opsy included when performed) using mechanical sion, percutaneous, including imaging guidance device (eg, kyphoplasty), 1 vertebral body, unilat- when performed; radio frequency). eral or bilateral cannulation, inclusive of all imaging guidance; thoracic). 20983 (Ablation therapy for reduction or eradication of 22514 (Percutaneous vertebral augmentation, includ- 5114 5115 1 or more bone tumors (eg, metastasis including ing cavity creation (fracture reduction and bone bi- adjacent soft tissue when involved by tumor exten- opsy included when performed) using mechanical sion, percutaneous, including imaging guidance device (eg, kyphoplasty), 1 vertebral body, unilat- when performed; radio frequency)). eral or bilateral cannulation, inclusive of all imaging guidance; lumbar). 28297 (Correction, hallux valgus (bunionectomy), with 28285 (Correction, hammertoe (eg, interphalangeal 5114 5115 sesamoidectomy, when performed; with first meta- fusion, partial or total phalangectomy)). tarsal and medial cuneiform joint with arthrodesis, any method). 28297 (Correction, hallux valgus (bunionectomy), with 28292 (Correction, hallux valgus (bunionectomy), with 5114 5115 sesamoidectomy, when performed; with first meta- sesamoidectomy, when performed; with resection tarsal and medial cuneiform joint with arthrodesis, of proximal phalanx base, when performed, any any method). method). 28740 (Arthrodesis, midtarsal or tarsometatarsal, sin- 28285 (Correction, hammertoe (eg, interphalangeal 5114 5115 gle joint). fusion, partial or total phalangectomy)). 61885 (Insertion or replacement of cranial 61885 (Insertion or replacement of cranial 5463 5464 nuerostimulator pulse generator or receiver, direct nuerostimulator pulse generator or receiver, direct or inductive coupling; with connection to a single or inductive coupling; with connection to a single electrode array). electrode array). 28740 (Arthrodesis, midtarsal or tarsometatarsal, sin- 28292 (Correction, hallux valgus (bunionectomy), with 5114 5115 gle joint). sesamoidectomy, when performed; with resection of proximal phalanx base, when performed, any method). 52234 (Cystourethroscopy, with biopsy(s)) ...... C9738 * (Adjunctive blue light cystoscopy with fluores- 5374 5375 cent imaging agent (List separately in addition to code for primary procedure)). 52235 (Cystourethroscopy, with fulguration (including C9738 * (Adjunctive blue light cystoscopy with fluores- 5374 5375 cryosurgery or laser surgery) of trigone, bladder cent imaging agent (List separately in addition to neck, prostatic fossa, urethra, or periurethral code for primary procedure)). glands).
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TABLE 5—C–APC COMPLEXITY ADJUSTMENTS REQUESTED BY THE COMMENTERS—Continued
Requested Primary APC complexity Primary ‘‘J1’’ HCPCS code Secondary ‘‘J1’’ HCPCS code assignment adjusted APC assignment
52240 (Cystourethroscopy with fulgration (including C9738 * (Adjunctive blue light cystoscopy with fluores- 5375 5376 cryosurgery or laser surgery) or treatment of cent imaging agent (List separately in addition to MINOR (less than 0.5 cm) lesion(s) with or without code for primary procedure)). biopsy). * HCPCS code C9738 was identified in the proposed rule as HCPCS code C97XX.
Other commenters requested various associated with the primary ‘‘J1’’ by the following codes were not changes to the complexity adjustment service. included in Addendum J: criteria. One commenter requested that A minimum of 25 claims is already • CPT code 22510 (Percutaneous CMS amend the current cost criterion very low for a national payment system. vertebroplasty (bone biopsy included for a complexity adjustment to allow for Lowering the minimum of 25 claims when performed), 1 vertebral body, code combinations that have qualified further could lead to unnecessary unilateral or bilateral injection, for a complexity adjustment in the complexity adjustments for service inclusive of all imaging guidance; previous year to qualify for a complexity combinations that are rarely performed. cervicothoracic) and CPT code 22512 adjustment for the subsequent year if The complexity adjustment cost (Percutaneous vertebroplasty (bone the code combination is within 5 threshold compares the code biopsy included when performed), 1 percent of the cost criterion for the combinations to the lowest cost vertebral body, unilateral or bilateral subsequent year. Another commenter significant procedure assigned to the injection, inclusive of all imaging requested that CMS eliminate the APC. If the cost of the code combination guidance; each additional criterion that the code combination does not exceed twice the cost of the cervicothoracic or lumbosacral vertebral must create a violation of the 2 times lowest cost significant procedure within body) for multi-level vertebroplasty in rule in the originating C–APC in order the cervicothoracic region); the APC, no complexity adjustment is • to qualify for a complexity adjustment. made. Lowering or eliminating this CPT code 22511 (Percutaneous Some commenters recommended that threshold could remove so many claims vertebroplasty (bone biopsy included CMS create a complexity adjustment for from the accounting for the primary when performed), 1 vertebral body, endoscopic sinus surgery claims that ‘‘J1’’ service that the geometric mean unilateral or bilateral injection, include a drug or device code (C-code costs attributed to the primary inclusive of all imaging guidance; or a J-code), or more than two ‘‘J1’’ procedure could be skewed. lumbosacral) and CPT code 22512 procedures. Other commenters Regarding the request for a code (Percutaneous vertebroplasty (bone biopsy included when performed), 1 requested that CMS revise its combination that qualified previously vertebral body, unilateral or bilateral complexity adjustment methodology to for a complexity adjustment to qualify injection, inclusive of all imaging account for the higher costs that for the subsequent year if the code guidance; each additional essential hospitals incur when combination is within 5 percent of the cervicothoracic or lumbosacral vertebral performing complex procedures and cost criterion for the subsequent year, body); and treating sicker patients. we evaluate code combinations each • CPT code 22511 (Percutaneous Response: We appreciate these year against our complexity adjustment vertebroplasty (bone biopsy included comments. However, at this time, we do criteria using the latest available data. when performed), 1 vertebral body, not believe changes to the C–APC We do not believe it is necessary to unilateral or bilateral injection, complexity adjustment criteria are expand the ability for code inclusive of all imaging guidance; necessary or that we should make combinations to meet the cost criterion lumbosacral) and CPT code 20982 exceptions to the criteria to allow claims in this manner. (Ablation therapy for reduction or with the code combinations suggested We also do not believe that it is eradication of 1 or more bone tumors by the commenters to receive necessary to adjust the complexity (e.g., metastasis), including adjacent soft complexity adjustments. As stated adjustment criteria to allow claims that tissue when involved by tumor previously (81 FR 79582), we continue include a drug or device code, more extension, percutaneous, including to believe that the complexity than two ‘‘J1’’ procedures, or procedures imaging guidance when performed; adjustment criteria, which require a performed at certain hospitals to qualify radiofrequency). frequency of 25 or more claims for a complexity adjustment. As Response: These code combinations reporting a code combination and a mentioned earlier, we believe the were inadvertently excluded from violation of the 2 times rule in the current criteria are adequate to Addendum J to the CY 2018 OPPS/ASC originating C–APC in order to receive determine if a combination of proposed rule. These code combinations payment in the next higher cost C–APC procedures represents a complex, costly and all other code combinations that within the clinical family, are adequate subset of the primary service. qualify for complexity adjustments are to determine if a combination of Comment: Some commenters noted included in Addendum J to this final procedures represents a complex, costly that there were certain code rule with comment period. subset of the primary service. If a code combinations that met the complexity Comment: One commenter stated that combination meets these criteria, the adjustment criteria that were not CMS should have included the combination receives payment at the included in Addendum J of the CY 2018 following add-on CPT codes in the next higher cost C–APC. Code OPPS/ASC proposed rule. Specifically, complexity adjustment evaluation: combinations that do not meet these commenters noted that the • CPT code 92978 (Endoluminal criteria receive the C–APC payment rate combinations of procedures described imaging of coronary vessel or graft using
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intravascular ultrasound (IVUS) or (82 FR 33576), we proposed to continue is more than 2 times greater than the optical coherence tomography (OCT) to apply the C–APC payment policy lowest cost for an item or service within during diagnostic evaluation and/or methodology made effective in CY 2015 the same APC group (the 2 times rule). therapeutic intervention including and updated with the implementation of In accordance with section 1833(t)(2) of imaging supervision, interpretation and status indicator ‘‘J2’’ in CY 2016. A the Act and § 419.31 of the regulations, report; initial vessel (List separately in discussion of the C–APC payment we annually review the items and addition to code for primary procedure); policy methodology can be found at 81 services within an APC group to • CPT code 92979 (Endoluminal FR 79583. determine if there are any APC imaging of coronary vessel or graft using As a result of our annual review of the violations of the 2 times rule and intravascular ultrasound (IVUS) or services and APC assignments under the whether there are any appropriate optical coherence tomography (OCT) OPPS, we did not propose any revisions to APC assignments that may during diagnostic evaluation and/or additional C–APCs to be paid under the be necessary or exceptions to be made. therapeutic intervention including existing C–APC payment policy In determining the APCs with a 2 times imaging supervision, interpretation and beginning in CY 2018. Table 4 of the rule violation, we consider only those report; each additional vessel (List proposed rule listed the proposed C– HCPCS codes that are significant based separately in addition to code for APCs for CY 2018, all of which were on the number of claims. primary procedure)); established in past rules. All C–APCs It is the cost of the primary item or • CPT code 93571 (Intravascular were displayed in Addendum J to the service that drives assignment to an Doppler velocity and/or pressure proposed rule (which is available via APC group. In this case, the primary derived coronary flow reserve the Internet on the CMS Web site). service is described by CPT code 67027, measurement (coronary vessel or graft) Addendum J to the proposed rule also which is the only CPT code assigned to during coronary angiography including contained all of the data related to the C–APC 5494 (Level 4 Intraocular pharmacologically induced stress; C–APC payment policy methodology, Procedures). The costs of drugs or other initial vessel (List separately in addition including the list of proposed packaged ancillary items or services that to code for primary procedure)); and complexity adjustments and other may be used with a primary service are • CPT code 93572 (Intravascular information. packaged into the costs of the primary Doppler velocity and/or pressure Comment: Several commenters service and are not separately paid. In derived coronary flow reserve supported the proposed C–APCs for CY this case, because CPT code 67027 is measurement (coronary vessel or graft) 2018. assigned to a C–APC, the costs of drugs, during coronary angiography including Response: We appreciate the such as Retisert, and any other items or pharmacologically induced stress; each commenters’ support. services that are billed with the ‘‘J1’’ additional vessel (List separately in Comment: Several commenters noted service are packaged into the geometric addition to code for primary procedure)) that CPT code 67027 (Implantation of mean cost for HCPCS code 67027 and in the complexity adjustment intravitreal drug delivery system (e.g., are bundled into the C–APC payment. evaluation. ganciclovir implant), includes The geometric mean cost is based on Response: We note that CPT codes concomitant removal of vitreous) is reported costs for all hospitals paid 92978 and 93571 were both included in assigned to a single-procedure C–APC under the OPPS; to the extent that the complexity adjustment evaluation in (C–APC 5494 (Level 4 Intraocular Retisert or other items are billed with Addendum J to the CY 2018 OPPS/ASC Procedures)) with status indicator ‘‘J1’’. the primary service, those costs are also proposed rule. However, CPT codes The commenters stated that the C–APC reflected in the cost of the primary 92979 and 93572 are not add-on codes policy packages payment for adjunctive service. Therefore, because the cost of to primary ‘‘J1’’ services. As stated in services into the payment for the the Retisert drug is packaged into the the CY 2018 OPPS/ASC proposed rule, primary ‘‘J1’’ procedure at the claim cost of CPT code 67027, assignment of to determine the code combinations that level, and that when the drug Retisert HCPCS code 67027 to C–APC 5494 does qualify for complexity adjustments, we (described by HCPCS code J7311) is not create a 2 times rule violation. apply the established frequency and included on the claim with CPT code In addition, with regard to the cost criteria thresholds and tests claims 62707, payment for the drug is packaged packaging of the drug Retisert based on reporting one unit of a single primary into the C–APC payment. The the C–APC policy, as stated in previous service assigned to status indicator ‘‘J1’’ commenters noted that the costs of rules (78 FR 74868 through 74869 and and any number of units of a single add- claims for the procedure, including the 74909 and 79 FR 66800), items included on code for the primary ‘‘J1’’ service (82 drug (approximately $18,433), were in the packaged payment provided with FR 33575). Accordingly, because CPT more than twice the proposed CY 2018 the primary ‘‘J1’’ service include all codes 92979 and 93572 are not add-on geometric mean cost for C–APC 5494 drugs, biologicals, and codes for any primary ‘‘J1’’ services, it (approximately $9,134) and that, as radiopharmaceuticals, regardless of cost, would not have been appropriate to such, this represents a violation of the except those drugs with pass-through include them in our complexity 2 times rule. The commenters suggested payment status and SADs, unless they adjustment evaluation. that CMS address this issue by either function as packaged supplies. After consideration of the public separately paying for Retisert (described Therefore, we believe that HCPCS code comments we received, we are applying by HCPCS code J7311) or creating a J3711 is appropriately packaged, and we the complexity adjustment criteria as unique APC for procedures with which are not providing separate payment for proposed. The finalized complexity HCPCS code J7311 may be billed. the drug. adjustments for CY 2018 can be found Response: As stated in the CY 2017 Comment: One commenter suggested in Addendum J to this final rule with OPPS/ASC final rule with comment that APC 5491 (Level 1 Intraocular comment period (which is available via period (81 FR 79612), section 1833(t)(2) Procedures) no longer be labeled a C– the Internet on the CMS Web site). of the Act provides that items and APC and instead be considered a services within an APC group cannot be traditional APC. The commenter noted (2) C–APCs for CY 2018 considered comparable with respect to that there was little cost difference for For CY 2018 and subsequent years, in the use of resources if the highest cost APC 5491 if it is considered a C–APC the CY 2018 OPPS/ASC proposed rule for an item or service in the APC group or a traditional APC and that no specific
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justification was given for making APC (CPT codes 99291 and 99292 (Critical (also known as the 3-day payment rule), 5491 a C–APC. The commenter care, evaluation and management of the when certain criteria are met. In suggested that only higher level critically ill or critically injured patient; addition, when a patient receiving Intraocular Procedure APCs have each additional 30 minutes) provided in critical care services in the hospital enough complexity to suggest that they the intensive care unit ICU). outpatient setting is transferred to the should be classified as C–APCs. Specifically, the commenter was ICU but is not admitted to the hospital Response: We continue to believe that concerned that the proposal would as an inpatient, payment for all eligible the procedures assigned to C–APC 5491 impact payment for tests that were services is made through C–APC 8011, are appropriately paid through a ordered and furnished in the emergency when certain criteria are met. We also comprehensive APC. As stated in the room when they are appropriately note that CPT code 99292 is an add-on CY 2017 OPPS/ASC final rule with repeated in the ICU and urged CMS to code which is packaged under the OPPS comment period (81 FR 79584), move with caution, and provide and is not one of the codes eligible to procedures assigned to C–APCs are transparency and impact tables for trigger payment through C–APC 8011. primary services (mostly major surgical hospitals, in continuing C–APC 8011. procedures) that are typically the focus Response: We appreciate this After consideration of the public of the hospital outpatient stay. comment and will continue to monitor comments we received, we are Therefore, we believe that these the impact of this C–APC on critical finalizing the proposed C–APCs for CY procedures are appropriately assigned to care services. We note that in situations 2018. Table 6 below lists the final C– a C–APC. where a patient receives critical care APCs for CY 2018, all of which were Comment: One commenter expressed services in the hospital outpatient established in past rules. All C–APCs concern that the proposal to continue to setting and is subsequently transferred are displayed in Addendum J to this assign status indicator ‘‘J2’’ to CPT code to the ICU as part of an appropriate final rule with comment period (which 99291 (Critical care, evaluation and hospital inpatient admission, payment is available via the Internet on the CMS management of the critically ill or for the services furnished in the hospital Web site). Addendum J to this final rule critically injured patient; first 30–74 outpatient setting, including critical with comment period also contains all minutes) and to assign it to C–APC 8011 care services, may be bundled into the of the data related to the C–APC (Comprehensive Observation Services) Part A hospital inpatient claim via the payment policy methodology, including when certain criteria are met would ‘‘Payment Window for Outpatient the list of complexity adjustments and have negative effects on critical care Services Treated as Inpatient Services other information for CY 2018.
TABLE 6—CY 2018 C–APCS
Clinical C–APC CY 2018 APC title family
5072 ...... Level 2 Excision/Biopsy/Incision and Drainage ...... EBIDX 5073 ...... Level 3 Excision/Biopsy/Incision and Drainage ...... EBIDX 5091 ...... Level 1 Breast/Lymphatic Surgery and Related Procedures ...... BREAS 5092 ...... Level 2 Breast/Lymphatic Surgery and Related Procedures ...... BREAS 5093 ...... Level 3 Breast/Lymphatic Surgery & Related Procedures ...... BREAS 5094 ...... Level 4 Breast/Lymphatic Surgery & Related Procedures ...... BREAS 5112 ...... Level 2 Musculoskeletal Procedures ...... ORTHO 5113 ...... Level 3 Musculoskeletal Procedures ...... ORTHO 5114 ...... Level 4 Musculoskeletal Procedures ...... ORTHO 5115 ...... Level 5 Musculoskeletal Procedures ...... ORTHO 5116 ...... Level 6 Musculoskeletal Procedures ...... ORTHO 5153 ...... Level 3 Airway Endoscopy ...... AENDO 5154 ...... Level 4 Airway Endoscopy ...... AENDO 5155 ...... Level 5 Airway Endoscopy ...... AENDO 5164 ...... Level 4 ENT Procedures ...... ENTXX 5165 ...... Level 5 ENT Procedures ...... ENTXX 5166 ...... Cochlear Implant Procedure ...... COCHL 5191 ...... Level 1 Endovascular Procedures ...... VASCX 5192 ...... Level 2 Endovascular Procedures ...... VASCX 5193 ...... Level 3 Endovascular Procedures ...... VASCX 5194 ...... Level 4 Endovascular Procedures ...... VASCX 5200 ...... Implantation Wireless PA Pressure Monitor ...... WPMXX 5211 ...... Level 1 Electrophysiologic Procedures ...... EPHYS 5212 ...... Level 2 Electrophysiologic Procedures ...... EPHYS 5213 ...... Level 3 Electrophysiologic Procedures ...... EPHYS 5222 ...... Level 2 Pacemaker and Similar Procedures ...... AICDP 5223 ...... Level 3 Pacemaker and Similar Procedures ...... AICDP 5224 ...... Level 4 Pacemaker and Similar Procedures ...... AICDP 5231 ...... Level 1 ICD and Similar Procedures ...... AICDP 5232 ...... Level 2 ICD and Similar Procedures ...... AICDP 5244 ...... Level 4 Blood Product Exchange and Related Services ...... SCTXX 5302 ...... Level 2 Upper GI Procedures ...... GIXXX 5303 ...... Level 3 Upper GI Procedures ...... GIXXX 5313 ...... Level 3 Lower GI Procedures ...... GIXXX 5331 ...... Complex GI Procedures ...... GIXXX 5341 ...... Abdominal/Peritoneal/Biliary and Related Procedures ...... GIXXX 5361 ...... Level 1 Laparoscopy & Related Services ...... LAPXX 5362 ...... Level 2 Laparoscopy & Related Services ...... LAPXX
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TABLE 6—CY 2018 C–APCS—Continued
Clinical C–APC CY 2018 APC title family
5373 ...... Level 3 Urology & Related Services ...... UROXX 5374 ...... Level 4 Urology & Related Services ...... UROXX 5375 ...... Level 5 Urology & Related Services ...... UROXX 5376 ...... Level 6 Urology & Related Services ...... UROXX 5377 ...... Level 7 Urology & Related Services ...... UROXX 5414 ...... Level 4 Gynecologic Procedures ...... GYNXX 5415 ...... Level 5 Gynecologic Procedures ...... GYNXX 5416 ...... Level 6 Gynecologic Procedures ...... GYNXX 5431 ...... Level 1 Nerve Procedures ...... NERVE 5432 ...... Level 2 Nerve Procedures ...... NERVE 5462 ...... Level 2 Neurostimulator & Related Procedures ...... NSTIM 5463 ...... Level 3 Neurostimulator & Related Procedures ...... NSTIM 5464 ...... Level 4 Neurostimulator & Related Procedures ...... NSTIM 5471 ...... Implantation of Drug Infusion Device ...... PUMPS 5491 ...... Level 1 Intraocular Procedures ...... INEYE 5492 ...... Level 2 Intraocular Procedures ...... INEYE 5493 ...... Level 3 Intraocular Procedures ...... INEYE 5494 ...... Level 4 Intraocular Procedures ...... INEYE 5495 ...... Level 5 Intraocular Procedures ...... INEYE 5503 ...... Level 3 Extraocular, Repair, and Plastic Eye Procedures ...... EXEYE 5504 ...... Level 4 Extraocular, Repair, and Plastic Eye Procedures ...... EXEYE 5627 ...... Level 7 Radiation Therapy ...... RADTX 5881 ...... Ancillary Outpatient Services When Patient Dies ...... N/A 8011 ...... Comprehensive Observation Services ...... N/A C–APC Clinical Family Descriptor Key: AENDO = Airway Endoscopy; AICDP = Automatic Implantable Cardiac Defibrillators, Pacemakers, and Related Devices; BREAS = Breast Surgery; COCHL = Cochlear Implant; EBIDX = Excision/Biopsy/Incision and Drainage; ENTXX = ENT Proce- dures; EPHYS = Cardiac Electrophysiology; EXEYE = Extraocular Ophthalmic Surgery; GIXXX = Gastrointestinal Procedures; GYNXX = Gynecologic Procedures; INEYE = Intraocular Surgery; LAPXX = Laparoscopic Procedures; NERVE = Nerve Procedures; NSTIM = Neurostimulators; ORTHO = Orthopedic Surgery; PUMPS = Implantable Drug Delivery Systems; RADTX = Radiation Oncology; SCTXX = Stem Cell Transplant; UROXX = Urologic Procedures; VASCX = Vascular Procedures; WPMXX = Wireless PA Pressure Monitor.
(3) Brachytherapy Insertion Procedures guidance, when performed; with indicated that we would not exclude placement of catheter(s) for intracavitary claims from the CY 2017 ratesetting In the CY 2017 OPPS/ASC final rule radioelement application); calculation because we generally do not with comment period (81 FR 79584), we • CPT code 41019 (Placement of remove claims from the claims finalized 25 new C–APCs. Some of the needles, catheters, or other device(s) accounting when stakeholders believe HCPCS codes assigned to the C–APCs into the head and/or neck region that hospitals included incorrect established for CY 2017 described (percutaneous, transoral, or transnasal) information on some claims (81 FR surgical procedures for inserting for subsequent interstitial radioelement 79583). However, we stated that we brachytherapy catheters/needles and application); would examine the claims for the other related brachytherapy procedures • CPT code 43241 brachytherapy insertion codes in such as the insertion of tandem and/or (Esophagogastroduodenoscopy, flexible, question and determine if any future ovoids and the insertion of Heyman transoral; with insertion of intraluminal adjustment to the methodology (or capsules. In the CY 2017 OPPS/ASC tube catheter); possibly code edits) would be final rule with comment period (81 FR • CPT code 55920 (Placement of appropriate. 79583), we stated that we received needles or catheters into pelvic organs As discussed in the CY 2018 OPPS/ public comments which noted that and/or genitalia (except prostate) for ASC proposed rule (82 FR 33577 claims that included several insertion subsequent interstitial radioelement through 33578), we analyzed the claims codes for brachytherapy devices often application); and that include brachytherapy insertion did not also contain a brachytherapy • CPT code 58346 (Insertion of codes assigned to status indicator ‘‘J1’’ treatment delivery code (CPT codes Heyman capsules for clinical and that received payment through a C– 77750 through 77799). The brachytherapy). APC, and we determined that several of brachytherapy insertion codes that The commenters concluded that these codes are frequently billed commenters asserted were not often brachytherapy delivery charges are without an associated brachytherapy billed with a brachytherapy treatment being underrepresented in ratesetting treatment code. As mentioned above, code included the following: under the C–APC methodology because stakeholders have expressed concerns • CPT code 57155 (Insertion of a correctly coded claim should typically that using claims for ratesetting for uterine tandem and/or vaginal ovoids include an insertion and treatment brachytherapy insertion procedures that for clinical brachytherapy); delivery code combination. The do not also include a brachytherapy • CPT code 20555 (Placement of commenters stated that the insertion treatment code may not capture all of needles or catheters into muscle and/or procedure and brachytherapy treatment the costs associated with the insertion soft tissue for subsequent interstitial delivery generally occur on the same procedure. To address this issue and radioelement application (at the time of day or within the same week and base payment on claims for the most or subsequent to the procedure)); therefore the services should appear on common clinical scenario, for CY 2018 • CPT code 31643 (Bronchoscopy, a claim together. In the CY 2017 OPPS/ and subsequent years, we indicated in rigid or flexible, including fluoroscopic ASC final rule with comment period, we the CY 2018 OPPS/ASC proposed rule
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(82 FR 33578) that we were establishing brachytherapy radiation treatment are appropriately applied to brachytherapy a code edit that requires a often performed on the same day or insertion procedures, including the brachytherapy treatment code when a within the same week and are often procedure described by CPT code brachytherapy insertion code is billed. billed on the same claim. However, 55875. These procedures, like other As noted in section II.A.2.c. of the based on comments received in procedures assigned to C–APCs, are proposed rule and this final rule with response to the code edit, it appears that primary services (mostly major surgical comment period, we also proposed to there may be some clinical scenarios procedures) that are typically the focus delete composite APC 8001 (LDR where that is not the case. Accordingly, of the hospital outpatient stay. As Prostate Brachytherapy Composite) and in light of the numerous comments mentioned previously, we welcome assign HCPCS code 55875 opposing this code edit and the input on alternative payment policies to (Transperineal placement of needles or information provided by commenters address concerns surrounding the catheters into prostate for interstitial that suggests that brachytherapy variation in hospital billing practices for radioelement application, with or insertion and treatment services may be radiation oncology while maintaining without cystoscopy) to status indicator appropriately furnished on different the C–APC policy, and we will continue ‘‘J1’’ and to provide payment for this dates and different claims, we have to monitor this issue. The APC procedure through the C–APC payment decided not to implement an edit which assignments for CPT codes 55920 and methodology, similar to the payment would require a brachytherapy 19298 are discussed in greater detail in methodology for other surgical insertion treatment code when a brachytherapy section XII.D.2. of this final rule with procedures related to brachytherapy. insertion code is billed. As we have comment period. Specifically, when HCPCS code 55875 previously stated, we rely on hospitals Comment: Some commenters is the primary service reported on a to bill all HCPCS codes accurately in requested that CMS continue to provide hospital outpatient claim, we proposed accordance with their code descriptors payment for the brachytherapy insertion to package payments for all adjunctive and CPT and CMS instructions, as procedures through the C–APC policy, services reported on the claim into the applicable, and to report charges on but exclude all radiation oncology codes payment for HCPCS code 55875. We claims and charges and costs on their on the claim (defined as CPT codes proposed to assign HCPCS code 55875 Medicare hospital cost reports 77261 through 77799) and make to C–APC 5375 (Level 5 Urology and appropriately (77 FR 68324). We will separate payment for the brachytherapy Related Services). The code edit for continue to examine the issues treatment delivery and related planning claims with brachytherapy services involving ratesetting for brachytherapy and preparation services in addition to described above that will be effective insertion procedures assigned to C– the C–APC payment for the January 1, 2018, will require the APCs and welcome the public’s input brachytherapy insertion procedures. brachytherapy application HCPCS code regarding alternative payment policies These commenters stated that this was 77778 (Interstitial radiation source that could appropriately address the similar to the C–APC policy for application; complex) to be included on issue while maintaining the C–APC stereotactic radiosurgery (SRS) the claim with the brachytherapy policy. treatment. insertion procedure (HCPCS code Comment: Some commenters Response: The policy intent of C– 55875). requested that CMS discontinue the C– APCs is to bundle payment for all Comment: Several commenters APC payment policy for all services related and adjunctive to the opposed the implementation of a code brachytherapy insertion codes identified primary ‘‘J1’’ procedure. We do not edit that requires a brachytherapy in the CY 2018 OPPS/ASC proposed believe that providing separate payment treatment code when a brachytherapy rule. These commenters expressed for radiation oncology codes that are insertion code is billed. These concerns that hospital billing practices included on a claim with a commenters noted that, in some cases, for radiation oncology services are brachytherapy insertion procedure the insertion procedure and the variable and inconsistent with the C– assigned to status indicator ‘‘J1’’ is in brachytherapy treatment are performed APC policy which packages services at accordance with the C–APC policy. on different days and reported on the claim level. The commenters stated With regard to the SRS treatment policy separate claims. The commenters also that, in some cases, needles or catheters to pay separately for the planning and noted that the brachytherapy insertion are surgically placed prior to the preparation procedures, as stated in the procedure and radiation treatment brachytherapy treatment delivery, CY 2017 OPPS/ASC final rule with delivery are not always performed in the which consists of multiple fractions comment period (81 FR 79583), this same facility, in which case they would over several days or weeks and may be policy is a temporary special exception be on different claims. The commenters delivered at a different site of service. to the C–APC packaging policy that stated that this practice pattern is The commenters also requested that packages all adjunctive services (with a especially common in the treatment of CMS continue the composite APC for few exceptions listed in Addendum J to breast cancer and related breast Low Dose Rate Brachytherapy instead of this final rule with comment period). brachytherapy catheter codes. assigning CPT code 55875 After consideration of the public Response: We appreciate the (Transperineal placement of needles or comments we received, we are not commenters’ views. We intended to catheters into prostate for interstitial establishing a code edit that requires a address the concerns raised by radioelement application, with or brachytherapy treatment code when a commenters in CY 2017 rulemaking without cystoscopy) to a C–APC (Level brachytherapy insertion code is billed. regarding ratesetting for C–APCs for 5 Urology and Related Services). The We are finalizing our proposal to delete brachytherapy insertion procedures by commenters stated that CPT codes composite APC 8001 (LDR Prostate establishing a code edit to require a 55920 and 19298 should be assigned to Brachytherapy Composite) and assign brachytherapy treatment code when a a different C–APC if CMS maintained HCPCS code 55875 (Transperineal brachytherapy insertion code is billed. the C–APC payment policy for placement of needles or catheters into This was largely based on information brachytherapy insertion procedures in prostate for interstitial radioelement received from commenters last year, in CY 2018. application, with or without cystoscopy) which commenters had suggested that Response: We continue to believe that to status indicator ‘‘J1’’ and to provide brachytherapy insertion procedures and the C–APC payment policy is payment for this procedure through the
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C–APC payment methodology, similar reported on claims separate from the However, the ‘‘CP’’ modifier has been to the payment methodology for other actual delivery of SRS treatment. used by a small number of providers surgical insertion procedures related to We stated in the CY 2016 OPPS/ASC since its establishment. In addition, our brachytherapy. final rule with comment period (80 FR analysis showed that several of the HCPCS codes that were billed with (4) C–APC 5627 (Level 7 Radiation 70336) that the intent of the C–APC modifier ‘‘CP’’ belonged to the group of Therapy) Stereotactic Radiosurgery policy is to package payment for all 10 SRS planning and preparation codes (SRS) services adjunctive to the primary ‘‘J1’’ procedure and that we believed that all that we pay separately and do not Stereotactic radiosurgery (SRS) is a essential planning and preparation require the use of modifier ‘‘CP’’. Also, type of radiation therapy that targets services related to the SRS treatment are some providers erroneously included multiple beams of radiation to precisely adjunctive to the SRS treatment delivery the modifier when reporting the HCPCS deliver radiation to a brain tumor while procedure. Therefore, payment for these code for the delivery of the LINAC- sparing the surrounding normal tissue. adjunctive services should be packaged based SRS treatment. As stated above, SRS treatment can be delivered by into the C–APC payment for the SRS the data collection period for SRS Cobalt-60-based (also referred to as treatment instead of reported on a claims with modifier ‘‘CP’’ was set to gamma knife) technology or robotic different claim and paid separately. To conclude on December 31, 2017. linear accelerator-based (LINAC)-based identify services that are adjunctive to Accordingly, for CY 2018, we are technology. As stated in the CY 2016 the primary SRS treatment described by deleting this modifier and discontinuing OPPS/ASC final rule with comment HCPCS codes 77371 and 77372, but its required use. period (80 FR 70336), section 634 of the reported on a different claim, we For CY 2018, we also proposed to American Taxpayer Relief Act (ATRA) established modifier ‘‘CP’’ which continue to make separate payments for of 2012 (Pub. L. 112–240) amended became effective in CY 2016 and the 10 planning and preparation section 1833(t)(16) of the Act by adding required the use of the modifier for CY services adjunctive to the delivery of the a new subparagraph (D) to require that 2016 and CY 2017. SRS treatment using either the Cobalt- OPPS payments for Cobalt-60-based SRS To ensure appropriate ratesetting for 60-based or LINAC-based technology be reduced to equal that of payments for when furnished to a beneficiary within LINAC-based SRS for covered OPD the SRS C–APC, we believed it was necessary to unbundle payment for the 1 month of the SRS treatment. The services furnished on or after April 1, continued separate payment of these 2013. Because section 1833(t)(16)(D) of adjunctive services for CY 2016 and CY 2017. Therefore, we finalized a policy to services will allow us to complete our the Act requires equal payment for SRS analysis of the claims data including treatment delivered by Cobalt-60-based change the payment for SRS treatment for the 10 SRS planning and preparation modifier ‘‘CP’’ from both CY 2016 and or LINAC-based technology, the two CY 2017 claims. As stated in the CY types of services involving SRS delivery services identified in our claims data (HCPCS codes 70551, 70552, 70553, 2017 OPPS/ASC final rule with instruments (which are described by comment period (81 FR 79583), we will HCPCS code 77371 (Radiation treatment 77011, 77014, 77280, 77285, 77290, 77295, and 77336) that were reported consider in the future whether delivery, stereotactic radiosurgery repackaging all adjunctive services [SRS], complete course of treatment differentially using HCPCS codes 77371 and 77372 both on the same claim as the (planning, preparation, and imaging, cranial lesion(s) consisting of 1 session; among others) back into cranial single multi-source Cobalt 60-based) and SRS services and on claims 1 month prior to the delivery of SRS services. session SRS is appropriate. HCPCS code 77372 (Linear accelerator- We invited public comments on these These codes were removed from the based)) are assigned to the same C–APC proposals. (C–APC 5627 Level 7 Radiation geometric mean cost calculations for C– Comment: Commenters generally Therapy). APC 5627. In addition, for CY 2016 and supported the proposal to continue to In the CY 2016 OPPS/ASC final rule CY 2017, we provided separate payment make separate payments for the with comment period (80 FR 70336), we for the 10 planning and preparation planning and preparation services stated that we had identified differences services adjunctive to the delivery of the adjunctive to the delivery of the SRS in the billing patterns for SRS SRS treatment using either the Cobalt- treatment and requested that CMS procedures delivered using Cobalt-60- 60-based or LINAC-based technology, continue to pay separately for these based and LINAC-based technologies. In even when the planning service was services in the future. Commenters also particular, our claims data analysis included on the same claim as the supported the deletion of modifier revealed that services involving SRS primary ‘‘J1’’ SRS treatment service. The ‘‘CP’’. delivered by Cobalt-60-based use of the modifier ‘‘CP’’ was not Response: We appreciate the technologies (as described by HCPCS required to identify these 10 planning commenters’ support. code 77371) typically included SRS and preparation codes. After consideration of the public treatment planning services (for As discussed in the CY 2018 OPPS/ comments we received, we are example, imaging studies, radiation ASC proposed rule (82 FR 33564 and finalizing our proposal to make separate treatment aids, and treatment planning) 33465), the data collection period for payments for the 10 planning and and the actual deliveries of SRS SRS claims with modifier ‘‘CP’’ began preparation services adjunctive to the treatment on the same date of service on January 1, 2016 and concludes on delivery of the SRS treatment using and reported on the same claim. In December 31, 2017. Based on our either the Cobalt-60-based or LINAC- contrast, claims data analysis results analysis of preliminary data collected based technology when furnished to a revealed that services involving SRS with modifier ‘‘CP’’, we have identified beneficiary within 1 month of the SRS delivered by LINAC-based technologies some additional services that are treatment. (as described by HCPCS code 77372) adjunctive to the primary SRS treatment frequently included services related to and reported on a different claim (5) Complexity Adjustment for Blue SRS treatment (for example, imaging outside of the 10 SRS planning and Light Cystoscopy Procedures studies, radiation treatment aids, and preparation codes that were removed As discussed in prior OPPS/ASC final treatment planning) that were provided from the SRS C–APC costs calculations rules with comment period, and most on different dates of service and and paid separately. recently in the CY 2017 OPPS/ASC final
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rule with comment period (81 FR procedures involving only white light Because APC 5372 is not a C–APC, 79668), we continue to believe that cystoscopy from those involving both cystoscopy procedures assigned to Level Cysview® (hexaminolevulinate HCl) white and blue light cystoscopy, which 2 Urology are not eligible for a (described by HCPCS code C9275) is a require additional resources compared complexity adjustment, and therefore, drug that functions as a supply in a to white light cystoscopy alone. we did not analyze these codes to diagnostic test or procedure and is As discussed in the CY 2018 OPPS/ determine whether they met the criteria therefore packaged with payment for the ASC proposed rule, after discussion for this adjustment. We modeled the primary procedure. In addition, as with our clinical advisors (including a data to determine which code pair discussed in section II.A.2.b.(1) of the urologist), we believe that blue light combinations exceed the claim CY 2018 OPPS/ASC proposed rule and cystoscopy represents an additional frequency and cost threshold in APC this final rule with comment period, elective but distinguishable service as 5373, APC 5374, and APC 5375, which drugs that are not eligible for pass- compared to white light cystoscopy that, are all C–APCs. In the proposed rule, we through payment are always packaged in some cases, may allow greater stated that the results of our analysis when billed with a comprehensive detection of bladder tumors in indicate that the code pair combination service. To maintain the integrity of the beneficiaries relative to white light of procedures described by proposed OPPS, we believe it is generally not cystoscopy alone. Given the additional new HCPCS code C9738 and cystoscopy appropriate to allow exceptions to our equipment, supplies, operating room procedures assigned to APC 5373 would drug packaging policy or comprehensive time, and other resources required to be eligible for a complexity adjustment APC policy that would result in separate perform blue light cystoscopy in based on current criteria and cost data payment for the drug based on the addition to white light cystoscopy, for because they meet the frequency and product’s ASP+6 percent payment rate. CY 2018, in the proposed rule, we cost criteria thresholds. Likewise, our While we did not propose in the CY proposed to create a new HCPCS C-code results indicated that the combination of 2018 proposed rule to pay separately for to describe blue light cystoscopy and to procedures described by proposed new Cysview®, we have heard concerns from allow for a complexity adjustment to HCPCS code C9738 and cystoscopy stakeholders that the payment for blue APC 5374 (Level 4 Urology and Related procedures assigned to APC 5374 and light cystoscopy procedures involving Services) for certain code combinations APC 5375 would not qualify for a Cysview® may be creating a barrier to in APC 5373 (Level 3 Urology and complexity adjustment because they do beneficiaries receiving access to Related Services). (In the proposed rule, not meet the frequency and cost criteria reasonable and necessary care for which we cited HCPCS code ‘‘C97XX’’ as a thresholds. there may not be a clinically comparable placeholder for the new code. However, We indicated in the proposed rule alternative. Therefore, as we stated in for ease of reading, hereafter in this that, under the C–APC policy, blue light the proposed rule, we revisited our section, we refer to the replacement cystoscopy would be packaged, but payment policy for blue light code HCPCS code C9738 (Adjunctive when performed with a cystoscopy cystoscopy procedures. As described in blue light cystoscopy with fluorescent procedure in APC 5373 and reported more detail below, we believe certain imaging agent (List separately in with proposed new HCPCS code C9738 code combinations for blue light addition to code for primary procedure)) in addition to the cystoscopy CPT code, cystoscopy procedures should be instead of the placeholder code.) there would be a complexity adjustment to the next higher level APC in the eligible to qualify for a complexity Specifically, to determine which code series, resulting in a higher payment adjustment, given the unique properties pair combinations of a procedure than for the white light cystoscopy of the procedure and resource costs. described by proposed new HCPCS code procedure alone. That is, if the code pair C9738 and a cystoscopy procedure Traditionally, white light (or combination of proposed new HCPCS would qualify for a complexity standard) cystoscopy, typically code C9738 with CPT code 52204, adjustment, we first crosswalked the performed by urologists, has been the 52214, or 52224 is reported on a claim, costs of the procedure described by gold standard for diagnosing bladder the claim will qualify for payment HCPCS code C9275 cancer. Enhanced bladder cancer reassignment from APC 5373 to APC (Hexaminolevulinate hcl) to the diagnostics, such as narrow band 5374. We stated that we plan to track procedure described by proposed new imaging or blue light cystoscopy, the utilization and the costs associated increase tumor detection in nonmuscle HCPCS code C9738 assigned status with white light/blue light cystoscopy invasive bladder cancer over white light indicator ‘‘N’’. Next, we identified the procedure combinations that will cystoscopy alone, thus enabling more procedure codes used to describe white receive a complexity adjustment. precise tumor removal by the urologist. light cystoscopy of the bladder which We invited public comments on our Blue light cystoscopy can only be include the following CPT codes and CY 2018 proposal to allow for a performed after performance of white APC assignments: complexity adjustment when a white light cystoscopy. Because blue light • APC 5372 (Level 2 Urology and light cystoscopy procedure followed by cystoscopy requires specialized imaging Related Services) a blue light cystoscopy procedure is equipment to view cellular uptake of the b CPT code 52000 performed. In addition, we sought dye that is not otherwise used in white • APC 5373 (Level 3 Urology and public comments on whether alternative light cystoscopy procedures, some Related Services) procedures, such as narrow band practitioners consider blue light b CPT code 52204 imaging, may be disadvantaged by this cystoscopy to be a distinct and b CPT code 52214 proposed policy. adjunctive procedure to white light b CPT code 52224 Comment: One commenter agreed that cystoscopy. However, the current CPT • APC 5374 (Level 4 Urology and there are differences in resource coding structure for cystoscopy Related Services) utilization between cystoscopy procedures does not identify blue light b CPT code 52234 procedures involving white light only cystoscopy in the coding descriptions b CPT code 52235 and cystoscopy procedures involving separate from white light cystoscopy. • APC 5375 (Level 5 Urology and both white light and blue light. Therefore, the existing cystoscopy CPT Related Services) However, the commenter recommended codes do not distinguish cystoscopy b CPT code 52240 that a proposal to expand the
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cystoscopy CPT codes be submitted to blue light cystoscopy procedure a complexity adjusted payment from the American Medical Association complexity adjustment payment APC 5373 to APC 5374. (AMA) to capture the resource proposal, we considered the unique With respect to the public comments distinction. The commenter stated that properties and resources required to on unpackaging Cysview to allow for the use of CPT codes and HCPCS C- perform blue light cystoscopy with separate payment in both the HOPD and codes (for example, the proposed Cysview. As described in the proposal, ASC settings, as we stated in the HCPCS code C9738) to capture we approximated the costs for the background section for the proposal, we cystoscopy procedures is duplicative, additional resources required to perform continue to believe that Cysview is a administratively burdensome, and can blue light cystoscopy by crosswalking drug that functions as a supply in a affect the quality of claims data. the costs associated with HCPCS code diagnostic test or procedure and Response: We appreciate the C9275 to HCPCS code C9738. We then therefore is packaged with payment for commenter’s concerns. However, we applied the established complexity the primary procedure. In the CY 2018 proposed to establish this code based on adjustment criteria to determine which OPPS/ASC proposed rule, we did not programmatic need under the OPPS to cystoscopy procedures, when performed propose to make any changes to the accurately describe blue light with blue light cystoscopy, would ‘‘drugs that function as a supply’’ cystoscopy procedures. Given that a qualify for a complexity adjustment. For packaging policy or make any CPT code that describes blue light this final rule with comment period, we corresponding proposals to pay cystoscopy with an optical imaging repeated the analysis to determine separately for Cysview in the HOPD and agent does not exist in the CY 2018 CPT which code pair combinations of ASC settings. Therefore, Cysview will code set published by the AMA, it is HCPCS code C9738 with a cystoscopy remain packaged. unclear to us why the commenter procedure CPT code satisfied the With respect to the recommendation believes HCPCS code C9738 would be complexity adjustment criteria. that we establish a payment duplicative, administratively Consistent with the proposed rule methodology for blue light cystoscopy burdensome, or affect the quality of results, based on the updated final rule with Cysview procedures conceptually claims data. Moreover, it is the with comment period claims data, the similar to the ASC device intensive combination of two different procedures code pair combination of HCPCS code payment policy, we did not propose that trigger a complexity adjustment; C9738 with CPT code 52204, 52214, or revisions to the ASC device-intensive therefore, two distinct CPT or HCPCS 52224 each will qualify for a complexity procedure policy. In addition, it is codes are necessary to effectuate a adjusted payment from APC 5373 to unclear to us exactly how such a policy complexity adjustment. If the AMA APC 5374. Because APC 5372 is not a would work and to what precise establishes a CPT code that describes C–APC, cystoscopy procedures assigned procedures in addition to blue light cystoscopy it might apply. Further, we blue light cystoscopy with an optical to Level 2 Urology are not eligible for a believe that the C–APC payment imaging agent, we would consider complexity adjustment. Therefore, we adequately reflects the average resources recognizing that CPT code under the did not analyze these codes to expended by hospitals as reflected in OPPS as a replacement for HCPCS code determine whether they were eligible hospital claims data. In addition, for C9738. for a complexity adjustment. Likewise, Comment: A few commenters especially costly cases, we believe our our analysis of the final rule claims data generally supported the proposal to proposed policy appropriately indicated that the combination of allow for a complexity adjustment for recognizes the additional costs of blue proposed HCPCS code C9738 and blue light cystoscopy with Cysview light cystoscopy with white light cystoscopy procedures assigned to APC procedures. Many commenters, cystoscopy through the complexity 5374 and APC 5375 would not qualify including several commenters with adjustment. We will continue to analyze experience utilizing blue light for a complexity adjustment because the data and evaluate whether cystoscopy with Cysview, shared their they do not meet the frequency and cost refinements to the C–APC policy, views on how this procedure has criteria thresholds. including the complexity adjustment positively affected patient care We did not propose and the criteria, should be considered in future management. These commenters commenters did not provide evidence to rulemaking. recommended that CMS apply a support waiving application of the Comment: A few commenters complexity adjustment to all blue light complexity adjustment criteria and responded to the solicitation for public cystoscopy with Cysview procedures allowing for a complexity adjustment comments on whether an alternative performed in HOPDs to improve whenever a blue light cystoscopy procedure, such as narrow band utilization and beneficiary access to procedure is performed with any white imaging, would be disadvantaged by the care. Alternatively, the commenters light cystoscopy procedure. To allow for blue light cystoscopy with Cysview recommended that CMS pay separately a complexity adjustment under any complexity adjustment proposal. One for Cysview to allow access in both circumstance would require a change to commenter, the manufacturer of white light and blue light cystoscopies the complexity adjustment criteria, Cysview, requested that CMS not in HOPD and ASC settings or establish which we did not propose. Therefore, establish a complexity adjustment for a payment methodology conceptually we are finalizing the blue light narrow band imaging because this similar to the device-intensive payment cystoscopy complexity adjustment imaging does not require a drug, procedure for ASCs. The commenters proposal, without modification. In additional technology, or additional suggested that a ‘‘device-intensive like’’ addition we are establishing HCPCS resource. The commenter stated that the payment for a cystoscopy procedure code C9738 (Adjunctive blue light equipment used in narrow band imaging performed in the ASC would be set cystoscopy with fluorescent imaging cystoscopy procedures is not different based on the service cost and the drug agent (List separately in addition to than the equipment for white light cost (as determined by the code for primary procedure)), which cystoscopy and does not require more manufacturer-reported average sales replaces proposed HCPCS code C97XX. resource time, expense, or cost to the price). For CY 2018, the code pair combination hospital because narrow band imaging Response: We appreciate the of HCPCS code C9738 with CPT code technology is part of the standard commenters’ support. In developing the 52204, 52214, or 52224 will qualify for equipment available for cystoscopic
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procedures. Another commenter, the specifically, using OPPS claims data for c. Calculation of Composite APC developer of narrow band imaging, the CY 2016 final rule with comment Criteria-Based Costs contended that the procedure shares period, the CY 2017 final rule with many clinical and procedural comment period, and the CY 2018 As discussed in the CY 2008 OPPS/ similarities with blue light cystoscopy proposed rule, which reflect an ASC final rule with comment period (72 with Cysview procedures, and therefore observation period of CY 2014 to CY FR 66613), we believe it is important narrow band imaging should be eligible 2016, we examined the effects of C– that the OPPS enhance incentives for for a complexity adjustment. In APCs and their impact on OPPS hospitals to provide necessary, high addition, the commenter expressed payments. We started with all hospital quality care as efficiently as possible. concern that a complexity adjustment outpatient claims billed on the 13X For CY 2008, we developed composite for blue light cystoscopy with Cysview claim-type and, from that, separately APCs to provide a single payment for and not narrow band imaging would identified HCPCS codes and APCs that groups of services that are typically provide a financial incentive for performed together during a single were subject to the comprehensive providers to choose one technology over clinical encounter and that result in the methodology in CYs 2015 and 2016 the other. However, the commenter did provision of a complete service. (that is, HCPCS codes or APCs assigned not provide cost information for narrow Combining payment for multiple, status indicator ‘‘J1’’ or ‘‘J2’’). Next, we band imaging. independent services into a single OPPS analyzed the claims to create a subset of Response: We appreciate the payment in this way enables hospitals claims that contain the HCPCS codes commenters’ responses. We do not to manage their resources with and APCs that were subject to the believe that the information presented maximum flexibility by monitoring and comprehensive methodology. Using the supports a complexity adjustment for adjusting the volume and efficiency of claims noted above, we analyzed claim narrow band imaging. The lack of cost services themselves. An additional frequency, line frequency, number of information for narrow band imaging advantage to the composite APC model billing units, and the total OPPS and the fact that narrow band imaging is that we can use data from correctly payment between CYs 2014 and 2016 does not require use of a contrast agent coded multiple procedure claims to (and, therefore, avoids the cost of for each HCPCS code and APC that had calculate payment rates for the specified contrast and the time associated with been previously identified. In reviewing combinations of services, rather than the administration of contrast) lead us to the cost statistics for HCPCS codes for relying upon single procedure claims question whether the resource costs of procedures with status indicator ‘‘S’’, narrow band imaging are the same as which may be low in volume and/or ‘‘T’’, or ‘‘V’’ in CY 2014 that were incorrectly coded. Under the OPPS, we those of blue light cystoscopy with assigned to a C–APC in either CY 2015 Cysview. For these reasons, we do not currently have composite policies for or CY 2016, overall, we observed an low dose rate (LDR) prostate believe it is appropriate to modify the increase in claim line frequency, units proposal to allow for a complexity brachytherapy, mental health services, billed, and Medicare payment, which and multiple imaging services. We refer adjustment when narrow band imaging suggest that the C–APC payment policy is performed with white light readers to the CY 2008 OPPS/ASC final did not adversely affect access to care or rule with comment period for a full cystoscopy. reduce payments to hospitals. Decreases After consideration of the public discussion of the development of the in these cost statistics would suggest our comments we received, we are composite APC methodology (72 FR comprehensive packaging logic is not finalizing our proposal, without 66611 through 66614 and 66650 through modification, to allow for a complexity working as intended and/or the C–APC 66652) and the CY 2012 OPPS/ASC adjustment when HCPCS code C9738 is payment rates were inadequate, final rule with comment period (76 FR reported on the same claim as CPT code resulting in lower volume due to 74163) for more recent background. migration of services to other settings or 52204, 52214, or 52224. The result of In the CY 2018 OPPS/ASC proposed billing any one of these three code pair the cessation of providing these services. Likewise, because the cost rule (82 FR 33580), for CY 2018 and combinations is a payment reassignment subsequent years, we proposed to from APC 5373 to APC 5374. statistics of major separately payable codes (that is, HCPCS codes with status continue our composite APC payment (6) Analysis of C–APC Packaging Under indicator ‘‘S’’, ‘‘T’’, or ‘‘V’’) that were policies for mental health services and the OPPS packaged into a C–APC prospectively multiple imaging services, as discussed In the CY 2017 OPPS/ASC final rule were consistent with the cost statistics below. As discussed in section II.A.2.b. with comment period (81 FR 79584), we of the codes packaged on the claim, in of the proposed rule and this final rule accepted a recommendation made at the actuality, indicate that costs were with comment period, we proposed to August 22, 2016 HOP Panel meeting to appropriately redistributed, we believe assign CPT code 55875 (Transperineal analyze the effects of C–APCs. The HOP the C–APC payment methodology is placement of needs or catheters into panel recommendation did not working as intended. prostate for interstitial radioelement elucidate specific concerns with the C– application, with or without cystoscopy) Comment: A few commenters a status indicator of ‘‘J1’’ and assign it APC policy or provide detailed appreciated CMS’ analysis of C–APC recommendations on particular aspects to a C–APC. In conjunction with this packaging under the OPPS and urged proposal, we also proposed to delete the of the policy to analyze. Therefore, we CMS to continue to monitor the data took a broad approach in studying low dose rate (LDR) prostate and report on any changes in billing HCPCS codes and APCs subject to the brachytherapy composite APC for CY patterns or utilization for particular C–APC policy to determine whether 2018 and subsequent years. We refer items or services. aberrant trends in the data existed. readers to section II.A.2.b. of the CY Overall, we observed no such Response: We appreciate the 2018 OPPS/ASC proposed rule and this aberrancies and believe that the C–APC commenters’ support. We will continue final rule with comment period for our policy is working as intended. to monitor the impact of our C–APC discussion on our low dose rate (LDR) As discussed in the CY 2018 OPPS/ policy on OPPS rate setting and evaluate prostate brachytherapy APC proposal ASC proposed rule (82 FR 33580), if future adjustments are needed. for CY 2018 and subsequent years.
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(1) Mental Health Services Composite all outpatient mental health services. provided either with or without APC Therefore, we do not believe that we contrast. The five multiple imaging In the CY 2018 OPPS/ASC proposed should pay more for mental health composite APCs established in CY 2009 services under the OPPS than the are: rule (82 FR 33580), we proposed to • continue our longstanding policy of highest partial hospitalization per diem APC 8004 (Ultrasound Composite); • APC 8005 (CT and CTA without limiting the aggregate payment for payment rate for hospitals. We did not receive any public Contrast Composite); specified less resource-intensive mental • APC 8006 (CT and CTA with health services furnished on the same comments on these proposals. Therefore, we are finalizing our CY 2018 Contrast Composite); date to the payment for a day of partial • APC 8007 (MRI and MRA without hospitalization services provided by a proposal, without modification, that when aggregate payment for specified Contrast Composite); and hospital, which we consider to be the • mental health services provided by one APC 8008 (MRI and MRA with most resource intensive of all outpatient hospital to a single beneficiary on a date Contrast Composite). mental health services. We refer readers of service, based on the payment rates We define the single imaging session to the April 7, 2000 OPPS final rule with the APCs for the individual for the ‘‘with contrast’’ composite APCs with comment period (65 FR 18452 services, exceeds the maximum per as having at least one or more imaging through 18455) for the initial discussion diem payment rate for partial procedures from the same family of this longstanding policy and the CY hospitalization services provided by a performed with contrast on the same 2012 OPPS/ASC final rule with hospital, those specified mental health date of service. For example, if the comment period (76 FR 74168) for more services will be paid through composite hospital performs an MRI without recent background. APC 8010 for CY 2018. In addition, we contrast during the same session as at In the CY 2017 OPPS/ASC final rule are finalizing our CY 2018 proposal, least one other MRI with contrast, the with comment period (81 FR 79588 without modification, to set the hospital will receive payment based on through 79589), we finalized a policy to payment rate for composite APC 8010 the payment rate for APC 8008, the combine the existing Level 1 and Level for CY 2018 at the same payment rate ‘‘with contrast’’ composite APC. 2 hospital-based PHP APCs into a single that we established for APC 5863, which We make a single payment for those hospital-based PHP APC and, thereby, is the maximum partial hospitalization imaging procedures that qualify for discontinue APCs 5861 (Level 1 Partial per diem payment rate for a hospital, payment based on the composite APC Hospitalization (3 services) for Hospital- and that the hospital continue to be paid payment rate, which includes any Based PHPs) and 5862 (Level 2 Partial the payment rate for composite APC packaged services furnished on the Hospitalization (4 or more services) for 8010. same date of service. The standard Hospital-Based PHPs) and replace them (noncomposite) APC assignments with APC 5863 (Partial Hospitalization (2) Multiple Imaging Composite APCs continue to apply for single imaging (3 or more services per day)). For CY (APCs 8004, 8005, 8006, 8007, and procedures and multiple imaging 2018, and subsequent years, we 8008) procedures performed across families. proposed that when the aggregate Effective January 1, 2009, we provide For a full discussion of the development payment for specified mental health a single payment each time a hospital of the multiple imaging composite APC services provided by one hospital to a submits a claim for more than one methodology, we refer readers to the CY single beneficiary on a single date of imaging procedure within an imaging 2009 OPPS/ASC final rule with service, based on the payment rates family on the same date of service, in comment period (73 FR 68559 through associated with the APCs for the order to reflect and promote the 68569). individual services, exceeds the efficiencies hospitals can achieve when In the CY 2018 OPPS/ASC proposed maximum per diem payment rate for performing multiple imaging procedures rule (82 FR 33581), we proposed, for CY partial hospitalization services provided during a single session (73 FR 41448 2018 and subsequent years, to continue by a hospital, those specified mental through 41450). We utilize three to pay for all multiple imaging health services would be paid through imaging families based on imaging procedures within an imaging family composite APC 8010 (Mental Health modality for purposes of this performed on the same date of service Services Composite) for CY 2018. In methodology: (1) Ultrasound; (2) using the multiple imaging composite addition, we proposed to set the computed tomography (CT) and APC payment methodology. We stated payment rate for composite APC 8010 computed tomographic angiography that we continue to believe that this for CY 2018 at the same payment rate (CTA); and (3) magnetic resonance policy would reflect and promote the that we proposed for APC 5863, which imaging (MRI) and magnetic resonance efficiencies hospitals can achieve when is the maximum partial hospitalization angiography (MRA). The HCPCS codes performing multiple imaging procedures per diem payment rate for a hospital, subject to the multiple imaging during a single session. and that the hospital continue to be paid composite policy and their respective The proposed CY 2018 payment rates the payment rate for composite APC families are listed in Table 12 of the CY for the five multiple imaging composite 8010. Under this policy, the I/OCE 2014 OPPS/ASC final rule with APCs (APCs 8004, 8005, 8006, 8007, would continue to determine whether to comment period (78 FR 74920 through and 8008) were based on proposed pay for these specified mental health 74924). geometric mean costs calculated from a services individually, or to make a While there are three imaging partial year of CY 2016 claims available single payment at the same payment families, there are five multiple imaging for the CY 2018 OPPS/ASC proposed rate established for APC 5863 for all of composite APCs due to the statutory rule that qualified for composite the specified mental health services requirement under section 1833(t)(2)(G) payment under the current policy (that furnished by the hospital on that single of the Act that we differentiate payment is, those claims reporting more than one date of service. We stated that we for OPPS imaging services provided procedure within the same family on a continue to believe that the costs with and without contrast. While the single date of service). To calculate the associated with administering a partial ultrasound procedures included under proposed geometric mean costs, we hospitalization program at a hospital the policy do not involve contrast, both used the same methodology that we represent the most resource intensive of CT/CTA and MRI/MRA scans can be used to calculate the final geometric
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mean costs for these composite APCs approximately 36 percent of all eligible discussed in section II.A.2.b. of this since CY 2014, as described in the CY claims, to calculate the proposed CY final rule with comment period, our C– 2014 OPPS/ASC final rule with 2018 geometric mean costs for the APC policy packages payment for comment period (78 FR 74918). The multiple imaging composite APCs. adjunctive and secondary items, imaging HCPCS codes referred to as Table 6 of the CY 2018 OPPS/ASC services, and procedures, including ‘‘overlap bypass codes’’ that we proposed rule listed the proposed diagnostic procedures, into the most removed from the bypass list for HCPCS codes that would be subject to costly procedure under the OPPS at the purposes of calculating the proposed the multiple imaging composite APC claim level. We believe that paying for multiple imaging composite APC policy and their respective families and composite APCs separately when billed geometric mean costs, in accordance approximate composite APC proposed with a service that has been assigned a with our established methodology as geometric mean costs for CY 2018. ‘‘J1’’ status indicator would be in stated in the CY 2014 OPPS/ASC final Comment: One commenter supported conflict with the intent of our C–APC rule with comment period (78 FR the composite APC policy for imaging policy and would not be appropriate. 74918), were identified by asterisks in services and recommended that CMS Addendum N to the CY 2018 OPPS/ASC pay composite imaging APCs separately After consideration of the public proposed rule (which is available via when billed on a claim with a service comments we received, we are the Internet on the CMS Web site) and that has been assigned a ‘‘J1’’ status finalizing our proposal to continue the were discussed in more detail in section indicator, that is, as a C–APC. use of multiple imaging composite APCs II.A.1.b. of the CY 2018 OPPS/ASC Response: We appreciate the to pay for services providing more than proposed rule. commenter’s support. Regarding the one imaging procedure from the same For the CY 2018 OPPS/ASC proposed recommendation about paying for family on the same date, without rule, we were able to identify composite APCs separately when billed modification. Table 7 below lists the approximately 634,918 ‘‘single session’’ on a claim with a service that has been HCPCS codes that will be subject to the claims out of an estimated 1.7 million assigned a ‘‘J1’’ status indicator, multiple imaging composite APC policy potential claims for payment through procedures assigned to C–APCs are and their respective families and composite APCs from our ratesetting primary services that are typically the approximate composite APC proposed claims data, which represents focus of the hospital outpatient stay. As geometric mean costs for CY 2018.
TABLE 7—OPPS IMAGING FAMILIES AND MULTIPLE IMAGING PROCEDURE COMPOSITE APCS
CY 2018 APC 8004 (ultrasound composite) CY 2018 approximate APC geometric mean cost = $300
Family 1—Ultrasound
76700 ...... Us exam, abdom, complete. 76705 ...... Echo exam of abdomen. 76770 ...... Us exam abdo back wall, comp. 76776 ...... Us exam k transpl w/Doppler. 76831 ...... Echo exam, uterus. 76856 ...... Us exam, pelvic, complete. 76857 ...... Us exam, pelvic, limited.
CY 2018 APC 8005 (CT and CTA without contrast composite) * CY 2018 approximate APC geometric mean cost = $275
Family 2—CT and CTA with and without Contrast
70450 ...... Ct head/brain w/o dye. 70480 ...... Ct orbit/ear/fossa w/o dye. 70486 ...... Ct maxillofacial w/o dye. 70490 ...... Ct soft tissue neck w/o dye. 71250 ...... Ct thorax w/o dye. 72125 ...... Ct neck spine w/o dye. 72128 ...... Ct chest spine w/o dye. 72131 ...... Ct lumbar spine w/o dye. 72192 ...... Ct pelvis w/o dye. 73200 ...... Ct upper extremity w/o dye. 73700 ...... Ct lower extremity w/o dye. 74150 ...... Ct abdomen w/o dye. 74261 ...... Ct colonography, w/o dye. 74176 ...... Ct angio abd & pelvis.
CY 2018 APC 8006 (CT and CTA with contrast composite) CY 2018 approximate APC geometric mean cost = $501
70487 ...... Ct maxillofacial w/dye. 70460 ...... Ct head/brain w/dye. 70470 ...... Ct head/brain w/o & w/dye. 70481 ...... Ct orbit/ear/fossa w/dye. 70482 ...... Ct orbit/ear/fossa w/o & w/dye. 70488 ...... Ct maxillofacial w/o & w/dye. 70491 ...... Ct soft tissue neck w/dye. 70492 ...... Ct sft tsue nck w/o & w/dye. 70496 ...... Ct angiography, head. 70498 ...... Ct angiography, neck. 71260 ...... Ct thorax w/dye.
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TABLE 7—OPPS IMAGING FAMILIES AND MULTIPLE IMAGING PROCEDURE COMPOSITE APCS—Continued 71270 ...... Ct thorax w/o & w/dye. 71275 ...... Ct angiography, chest. 72126 ...... Ct neck spine w/dye. 72127 ...... Ct neck spine w/o & w/dye. 72129 ...... Ct chest spine w/dye. 72130 ...... Ct chest spine w/o & w/dye. 72132 ...... Ct lumbar spine w/dye. 72133 ...... Ct lumbar spine w/o & w/dye. 72191 ...... Ct angiograph pelv w/o & w/dye. 72193 ...... Ct pelvis w/dye. 72194 ...... Ct pelvis w/o & w/dye. 73201 ...... Ct upper extremity w/dye. 73202 ...... Ct uppr extremity w/o & w/dye. 73206 ...... Ct angio upr extrm w/o & w/dye. 73701 ...... Ct lower extremity w/dye. 73702 ...... Ct lwr extremity w/o & w/dye. 73706 ...... Ct angio lwr extr w/o & w/dye. 74160 ...... Ct abdomen w/dye. 74170 ...... Ct abdomen w/o & w/dye. 74175 ...... Ct angio abdom w/o & w/dye. 74262 ...... Ct colonography, w/dye. 75635 ...... Ct angio abdominal arteries. 74177 ...... Ct angio abd & pelv w/contrast. 74178 ...... Ct angio abd & pelv 1+ regns.
* If a ‘‘without contrast’’ CT or CTA procedure is performed during the same session as a ‘‘with contrast’’ CT or CTA procedure, the I/OCE as- signs the procedure to APC 8006 rather than APC 8005.
CY 2018 APC 8007 (MRI and MRA without contrast composite) * CY 2018 approximate APC geometric mean cost = $556
Family 3—MRI and MRA with and without Contrast
70336 ...... Magnetic image, jaw joint. 70540 ...... Mri orbit/face/neck w/o dye. 70544 ...... Mr angiography head w/o dye. 70547 ...... Mr angiography neck w/o dye. 70551 ...... Mri brain w/o dye. 70554 ...... Fmri brain by tech. 71550 ...... Mri chest w/o dye. 72141 ...... Mri neck spine w/o dye. 72146 ...... Mri chest spine w/o dye. 72148 ...... Mri lumbar spine w/o dye. 72195 ...... Mri pelvis w/o dye. 73218 ...... Mri upper extremity w/o dye. 73221 ...... Mri joint upr extrem w/o dye. 73718 ...... Mri lower extremity w/o dye. 73721 ...... Mri jnt of lwr extre w/o dye. 74181 ...... Mri abdomen w/o dye. 75557 ...... Cardiac mri for morph. 75559 ...... Cardiac mri w/stress img. C8901 ...... MRA w/o cont, abd. C8904 ...... MRI w/o cont, breast, uni. C8907 ...... MRI w/o cont, breast, bi. C8910 ...... MRA w/o cont, chest. C8913 ...... MRA w/o cont, lwr ext. C8919 ...... MRA w/o cont, pelvis. C8932 ...... MRA, w/o dye, spinal canal. C8935 ...... MRA, w/o dye, upper extr
CY 2018 APC 8008 (MRI and MRA with contrast composite) CY 2018 approximate APC geometric mean cost = $871
70549 ...... Mr angiograph neck w/o & w/dye. 70542 ...... Mri orbit/face/neck w/dye. 70543 ...... Mri orbt/fac/nck w/o & w/dye. 70545 ...... Mr angiography head w/dye. 70546 ...... Mr angiograph head w/o & w/dye. 70547 ...... Mr angiography neck w/o dye. 70548 ...... Mr angiography neck w/dye. 70552 ...... Mri brain w/dye. 70553 ...... Mri brain w/o & w/dye. 71551 ...... Mri chest w/dye. 71552 ...... Mri chest w/o & w/dye. 72142 ...... Mri neck spine w/dye. 72147 ...... Mri chest spine w/dye. 72149 ...... Mri lumbar spine w/dye.
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TABLE 7—OPPS IMAGING FAMILIES AND MULTIPLE IMAGING PROCEDURE COMPOSITE APCS—Continued 72156 ...... Mri neck spine w/o & w/dye. 72157 ...... Mri chest spine w/o & w/dye. 72158 ...... Mri lumbar spine w/o & w/dye. 72196 ...... Mri pelvis w/dye. 72197 ...... Mri pelvis w/o & w/dye. 73219 ...... Mri upper extremity w/dye. 73220 ...... Mri uppr extremity w/o & w/dye. 73222 ...... Mri joint upr extrem w/dye. 73223 ...... Mri joint upr extr w/o & w/dye. 73719 ...... Mri lower extremity w/dye. 73720 ...... Mri lwr extremity w/o & w/dye. 73722 ...... Mri joint of lwr extr w/dye. 73723 ...... Mri joint lwr extr w/o & w/dye. 74182 ...... Mri abdomen w/dye. 74183 ...... Mri abdomen w/o & w/dye. 75561 ...... Cardiac mri for morph w/dye. 75563 ...... Card mri w/stress img & dye. C8900 ...... MRA w/cont, abd. C8902 ...... MRA w/o fol w/cont, abd. C8903 ...... MRI w/cont, breast, uni. C8905 ...... MRI w/o fol w/cont, brst, un. C8906 ...... MRI w/cont, breast, bi. C8908 ...... MRI w/o fol w/cont, breast. C8909 ...... MRA w/cont, chest. C8911 ...... MRA w/o fol w/cont, chest. C8912 ...... MRA w/cont, lwr ext. C8914 ...... MRA w/o fol w/cont, lwr ext. C8918 ...... MRA w/cont, pelvis. C8920 ...... MRA w/o fol w/cont, pelvis. C8931 ...... MRA, w/dye, spinal canal. C8933 ...... MRA, w/o&w/dye, spinal canal. C8934 ...... MRA, w/dye, upper extremity. C8936 ...... MRA, w/o&w/dye, upper extr. * If a ‘‘without contrast’’ MRI or MRA procedure is performed during the same session as a ‘‘with contrast’’ MRI or MRA procedure, the I/OCE assigns the procedure to APC 8008 rather than APC 8007.
3. Changes to Packaged Items and separate payment is provided for the a fundamental part of the OPPS since its Services item. implementation in August 2000. For an Packaging also encourages hospitals extensive discussion of the history and a. Background and Rationale for to effectively negotiate with background of the OPPS packaging Packaging in the OPPS manufacturers and suppliers to reduce policy, we refer readers to the CY 2000 Like other prospective payment the purchase price of items and services OPPS final rule (65 FR 18434), the CY systems, the OPPS relies on the concept or to explore alternative group 2008 OPPS/ASC final rule with of averaging to establish a payment rate purchasing arrangements, thereby comment period (72 FR 66580), the CY encouraging the most economical health for services. The payment may be more 2014 OPPS/ASC final rule with care delivery. Similarly, packaging or less than the estimated cost of comment period (78 FR 74925), the CY encourages hospitals to establish providing a specific service or a bundle 2015 OPPS/ASC final rule with protocols that ensure that necessary comment period (79 FR 66817), the CY of specific services for a particular services are furnished, while 2016 OPPS/ASC final rule with patient. The OPPS packages payments scrutinizing the services ordered by comment period (80 FR 70343), and the for multiple interrelated items and practitioners to maximize the efficient CY 2017 OPPS/ASC final rule with services into a single payment to create use of hospital resources. Packaging comment period (81 FR 79592). As we incentives for hospitals to furnish payments into larger payment bundles continue to develop larger payment services most efficiently and to manage promotes the predictability and groups that more broadly reflect services their resources with maximum accuracy of payment for services over provided in an encounter or episode of flexibility. Our packaging policies time. Finally, packaging may reduce the care, we have expanded the OPPS support our strategic goal of using larger importance of refining service-specific packaging policies. Most, but not payment bundles in the OPPS to payment because packaged payments necessarily all, items and services maximize hospitals’ incentives to include costs associated with higher currently packaged in the OPPS are provide care in the most efficient cost cases requiring many ancillary listed in 42 CFR 419.2(b). Our manner. For example, where there are a items and services and lower cost cases overarching goal is to make OPPS variety of devices, drugs, items, and requiring fewer ancillary items and payments for all services paid under the supplies that could be used to furnish services. Because packaging encourages OPPS more consistent with those of a a service, some of which are more costly efficiency and is an essential component prospective payment system and less than others, packaging encourages of a prospective payment system, like those of a per-service fee schedule, hospitals to use the most cost-efficient packaging payments for items and which pays separately for each coded item that meets the patient’s needs, services that are typically integral, item. As a part of this effort, we have rather than to routinely use a more ancillary, supportive, dependent, or continued to examine the payment for expensive item, which often occurs if adjunctive to a primary service has been items and services provided under the
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OPPS to determine which OPPS finalize our proposal to package drug mean cost of less than or equal to $100 services can be packaged to further administration add-on codes (78 FR (prior to application of the conditional achieve the objective of advancing the 74945). packaging status indicator) should OPPS toward a more prospective In the CY 2015 OPPS/ASC final rule continue to be excluded from the payment system. with comment period (79 FR 66819 ancillary services packaging policy. For CY 2018, we examined the items through 66822), we conditionally As part of our review of CY 2016 and services currently provided under packaged payment for ancillary services claims data used for ratesetting in the the OPPS, reviewing categories of assigned to APCs with a geometric mean CY 2018 OPPS/ASC proposed rule, we integral, ancillary, supportive, cost of less than or equal to $100 (prior examined drug administration billing dependent, or adjunctive items and to application of the conditional patterns and payment for drug services for which we believe payment packaging status indicator). The administration services under the OPPS. would be appropriately packaged into ancillary services that we identified are Based on our analysis of CY 2016 claims payment of the primary service that they primarily minor diagnostic tests and data used for the CY 2018 proposed rule support. Specifically, we examined the procedures that are often performed ratesetting, we found that the geometric HCPCS code definitions (including CPT with a primary service, although there mean cost for APC 5691 (Level 1 Drug code descriptors) and outpatient are instances where hospitals provide Administration) is approximately $37 hospital billing patterns to determine such services alone and without another and the geometric mean cost for APC whether there were categories of codes primary service during the same 5692 (Level 2 Drug Administration) is for which packaging would be encounter. Under this policy, we approximately $59. In addition, we appropriate according to existing OPPS assigned the conditionally packaged observed that drug administration packaging policies or a logical services to status indicator ‘‘Q1’’, which services in APC 5692 are frequently expansion of those existing OPPS indicates that the service is separately reported on the same claim with other packaging policies. In the CY 2018 payable when not billed on the same separately payable services, such as an OPPS/ASC proposed rule (82 FR 33584 claim as a HCPCS code assigned status emergency department or clinic visit, through 33585), for CY 2018, we indicator ‘‘S’’, ‘‘T’’, or ‘‘V’’. Exclusions while drug administration services in proposed to conditionally package the to this ancillary service packaging APC 5691 are sometimes reported with costs of selected newly identified policy include preventive services, other separately payable services. ancillary services into payment with a certain psychiatric and counseling- Accordingly, Medicare data show that primary service where we believe that related services, and certain low-cost these drug administration services are the packaged item or service is integral, drug administration services. In the CY currently being provided as part of ancillary, supportive, dependent, or 2015 OPPS/ASC final rule with another separately payable service for adjunctive to the provision of care that comment period (79 FR 66819), we which two separate payments are made, was reported by the primary service indicated that we did not propose to and support that packaging these HCPCS code. Below we discuss the package certain low-cost drug services, when they are reported with items and services that we proposed to administration services because we another separately payable service, is package beginning in CY 2018. were examining various alternative appropriate. Further, packaging for payment policies for drug Levels 1 and 2 Drug Administration b. Drug Administration Packaging administration, including the associated services is consistent with the ancillary Policy drug administration add-on codes. packaging policy that was adopted in CY 2015, as noted earlier in this section. (1) Background of Drug Administration (2) Packaging of Level 1 and Level 2 Therefore, given the low geometric Packaging Policy Drug Administration Services mean costs of drug administration In the CY 2014 OPPS/ASC final rule As stated earlier, our overarching goal services in APC 5691 and APC 5692 as with comment period (78 FR 74942 is to make OPPS payments for all well as their associated billing patterns, through 74945), we finalized a policy to services paid under the OPPS more we stated in the CY 2018 OPPS/ASC unconditionally package procedures consistent with those of a prospective proposed rule that we believe that when described by add-on codes. Procedures payment system and less like those of a these services are performed with described by add-on codes represent an per-service fee schedule. To achieve this another separately payable service, they extension or continuation of a primary goal, it is important that we are should be packaged, but that they procedure, which means that they are consistent in our approach to packaging should be separately paid when typically supportive, dependent, or items and services under the established performed alone. That is, we stated that adjunctive to a primary service. The packaging categories. Although we we believe it is no longer necessary to primary code defines the purpose and excluded packaging of low-cost drug exclude low-cost drug administration typical scope of the patient encounter administration services from the services from packaging under the and the add-on code describes ancillary services packaging policy in ancillary services packaging policy incremental work, when the extent of the CY 2015 rulemaking, separate adopted in CY 2015. the procedure encompasses a range payment for drug administration In addition, as we examine payment rather than a single defined endpoint services is an example of inconsistent differences between the hospital applicable to all patients. Given the application of our packaging policy outpatient department and the dependent nature and adjunctive where we are continuing to pay physician office for similar services, characteristics of procedures described separately for a service, regardless of under the OPPS, hospitals may receive by add-on codes and in light of cost and performance with another separate payments for a clinic (office) longstanding OPPS packaging service. Given the frequency of drug visit and a drug administration service. principles, we finalized a policy to administration in hospital outpatient In contrast, physicians are not eligible to unconditionally package add-on codes care, in the CY 2018 OPPS/ASC receive payment for an office visit when with the primary procedure. However, proposed rule, we stated that we believe a drug administration service is also in response to stakeholder comments on it is appropriate for us to reconsider provided. As a result, for furnishing the the appropriateness of packaging drug whether payment for drug same drug administration service, administration add-on codes, we did not administration services with a geometric hospitals receive an additional payment
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for which physician offices are not • Packaging drug administration billing patterns for these services. As eligible. We stated in the proposed rule services with other services could result stated earlier in the introduction to this that we believe that conditional in hospitals scheduling patients for section, ancillary services are often packaging of drug administration multiple visits, thereby reducing access performed with a primary service. services would promote equitable to care and quality of care. Because these low-cost drug payment between the physician office • Further analysis of the impact administration services are typically and the hospital outpatient hospital packaging drug administration services furnished with another primary service department. Accordingly, for CY 2018, would have on APCs should be and are assigned to APCs with a we proposed to conditionally package conducted prior to making a policy geometric mean cost of less than or payment for HCPCS codes describing change. equal to $100 (prior to the application drug administration services in APC • In general, packaging discourages of the conditional packaging status 5691 and APC 5692, except for add-on full reporting of hospital costs, which indicator), we believe these services fall codes and preventive services, when impacts the accuracy of cost data that under the ancillary services packaging these services are performed with are used to calculate OPPS payment policy. another service. rates. In addition, as stated in the proposed Because preventive services are In addition, at the summer 2017 rule, we believe that conditional excluded from our packaging policies, meeting of the HOP Panel, the HOP packaging of drug administration we proposed to continue to pay Panel recommended that CMS not services will promote equitable payment separately for Medicare Part B vaccine implement its proposal to package drug between the physician office and the administration services. In addition, at administration services described under hospital outpatient department. that time, we did not propose to package APC 5691 (Level 1 Drug Administration) However, we clarify that while typically any drug administration services in APC and APC 5692 (Level 2 Drug physicians are not eligible to receive 5693 (Level 3 Drug Administration) or Administration). payment for an office visit when a drug APC 5694 (Level 4 Drug Response: We appreciate the detailed administration service is also provided, Administration), but indicated our responses to our proposal and agree we acknowledge that Medicare will pay interest in public comments pertaining with the statements concerning the for both services when the office visit to whether payment for the services in importance of payment accuracy to CPT code is reported with Modifier 25 these APCs may be appropriate for maintain access to care. However, we (Significant, separately identifiable packaging. The proposed status disagree that conditional packaging of evaluation and management services by indicators for drug administration low-level drug administration services, the same physician on the day of the services in APC 5691 and APC 5692 which are commonly furnished both in procedure). were listed in Table 7 of the proposed the hospital outpatient setting and in With respect to data availability and rule. the physician office setting, would lead general requests for further CMS Comment: Numerous commenters to payment inaccuracy for hospital rates analysis, we believe that the data made disagreed with CMS’ proposal to for these services (which would include available to the public as part of the conditionally package low-cost drug the packaged costs of these services) or proposed rule were appropriate, clear, administration services assigned to APC to decreased access to drug and sufficient for interested parties to 5691 and APC 5692. The commonly administration services. As stated in the conduct analyses to evaluate facility- cited concerns among the commenters proposed rule, we believe it is no longer specific impacts of the proposed policy. who opposed the proposal were as necessary to exclude low-cost drug It is unclear what the commenters follows: administration services from packaging meant by requesting that CMS further • Low-cost drug administration under the ancillary services packaging analyze the effects of the proposal on services are dissimilar from other low policy adopted in CY 2015, which is APCs, as the commenters did not cost ancillary services in that drug supported by our analysis of drug specify any particular analysis that CMS administration services are separate and administration billing patterns. As should conduct or data that CMS should distinct stand-alone services and not described earlier in the introduction to provide that is not already available to adjunctive, supportive, or dependent to this section, our analysis of CY 2016 the public. Because the OPPS is a a primary procedure. OPPS claims data showed that low-cost budget neutral payment system, • The proposal would not promote drug administration services are packaging a procedure does not remove equitable payment between the currently being provided as part of its costs from ratesetting. physician’s office and the hospital another separately payable service for With respect to commenters’ concerns outpatient department because, in which two separate payments are made, on reporting of hospital costs for accordance with CMS guidelines, there and supported a policy that packaging packaged services, we remind are clinical circumstances where a low-cost drug administration services, commenters that hospitals are expected physician may receive payment for both when they are reported with another to report all HCPCS codes that describe a drug administration service and an separately payable service, is the services provided, regardless of office visit. appropriate. In response to the whether or not those services are • Because all drugs are separately commenters who raised concerns separately paid or their payment is payable in the physician’s office, unlike regarding potential behavioral changes packaged. The calculation of OPPS under the OPPS, the proposal, if by providers as a consequence of the relative payment weights that reflect the implemented, would exacerbate proposal, we will continue to monitor relative resources required for HOPD differences in payment between the the data for changes in drug services is the foundation of the OPPS. hospital outpatient department and the administration billing patterns. We rely on hospitals to bill all HCPCS physician office setting. Commenters Furthermore, regarding the comments codes accurately in accordance with expressed doubt that the full cost of a that low-cost drug administration their code descriptors and CPT and packaged drug administration service or services are separate and distinct CMS instructions, as applicable, and to drug would be appropriately and standalone services and not adjunctive, report charges on claims and charges accurately reflected in the payment for supportive, or dependent to a primary and costs on their Medicare hospital another separately payable procedure. procedure, we disagree based on typical cost report appropriately (77 FR 68324).
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Therefore, for the reasons stated the ‘‘OPPS Limited Data Set’’ (LDS) that service and an unconditionally above, we believe that it is appropriate, is available on the CMS Web site at: packaged drug, the drug administration and a logical expansion of our ancillary https://www.cms.gov/Research- service is separately payable when not services policy, to finalize our proposal Statistics-Data-and-Systems/Files-for- billed on the same claim as a HCPCS to unconditionally package low-cost Order/LimitedDataSets/ code with status indicator ‘‘S’’, ‘‘T’’, or drug administration services assigned to HospitalOPPS.html. We believe the ‘‘V’’. Payment for the threshold- APCs 5691 and 5692. Accordingly, we information contained in the PUF and packaged drug would be packaged with are not accepting the HOP Panel’s LDS files is sufficient to allow the payment for the highest paying recommendation to not finalize our stakeholders to analyze the effects of our separately payable procedure reported proposal. policies on their areas of interest. on the claim. For example, if a Comment: One commenter stated that Therefore, we are finalizing our threshold-packaged drug, a low-cost the packaging proposal is a logical proposal to conditionally package low- drug administration service, and a clinic expansion of the current ancillary cost drug administration services visit are reported on the same claim, packaging policy but recommended a 1- assigned to APC 5691 and APC 5692, payment for the drug and drug year implementation delay to allow effective January 1, 2018. administration service would be providers time to assess the Comment: Some commenters believed packaged with the clinic visit payment. administrative and fiscal impact. that the proposal would conditionally In summary, after consideration of the Response: We appreciate the package Medicare Part B vaccine public comments we received, we are commenter’s support. Packaging is a administration. In addition, some finalizing, without modification, the longstanding payment principle under commenters believed that if a hospital proposed policy to conditionally the OPPS and CMS has packaged a provides a low-cost drug administration package low-cost drug administration number of items and services through service for a drug that is services assigned to APC 5691 and APC the years and makes OPPS data unconditionally packaged, CMS would 5692. available to all interested parties on its make no payment to the hospital. Because preventive services are Web site. Therefore, we do not see a Response: We believe that some excluded from our packaging policies, reason to delay implementation of the commenters may have misunderstood we are continuing to pay separately for policy. With each proposed and final the proposal. Consistent with our Medicare Part B vaccine administration rule release, CMS posts on its Web site existing policy to exclude preventive services. In addition, at this time, we are various public use files (PUFs), services from packaging, administration not packaging any drug administration including payment rates and cost of Part B vaccines—influenza, services assigned to APC 5693 (Level 3 statistics for applicable items and pneumococcal, and hepatitis B—are Drug Administration) or APC 5694 procedures. Stakeholders interested in a exempt from packaging and will (Level 4 Drug Administration). The more comprehensive analysis of OPPS continue to be paid separately. With status indicators for drug administration claims data used to derive the CY 2018 respect to payment for a conditionally services in APC 5691 and APC 5692 for OPPS/ASC payment rates may purchase packaged low-cost drug administration CY 2018 are listed in Table 8 below.
TABLE 8—CY 2018 STATUS INDICATORS FOR DRUG ADMINISTRATION SERVICES IN LEVEL 1 AND LEVEL 2 DRUG ADMINISTRATION APCS
CY 2018 HCPCS code Short descriptor status indicator
APC 5691—Level 1 Drug Administration
95115 ...... Immunotherapy one injection ...... Q1 95117 ...... Immunotherapy injections ...... Q1 95144 ...... Antigen therapy services ...... Q1 95145 ...... Antigen therapy services ...... Q1 95146 ...... Antigen therapy services ...... Q1 95165 ...... Antigen therapy services ...... Q1 95170 ...... Antigen therapy services ...... Q1 96361 ...... Hydrate iv infusion add-on ...... S 96366 ...... Ther/proph/diag iv inf addon ...... S 96370 ...... Sc ther infusion addl hr ...... S 96375 ...... Tx/pro/dx inj new drug addon ...... S 96377 ...... Application on-body injector ...... Q1 96379 ...... Ther/prop/diag inj/inf proc ...... Q1 96423 ...... Chemo ia infuse each addl hr ...... S 96549 ...... Chemotherapy unspecified ...... Q1 G0008 ...... Admin influenza virus vac ...... S G0009 ...... Admin pneumococcal vaccine ...... S G0010 ...... Admin hepatitis b vaccine ...... S
APC 5692—Level 2 Drug Administration
90471 ...... Immunization admin ...... Q1 90473 ...... Immune admin oral/nasal ...... Q1 95147 ...... Antigen therapy services ...... Q1 95148 ...... Antigen therapy services ...... Q1 95149 ...... Antigen therapy services ...... Q1 96367 ...... Tx/proph/dg addl seq iv inf ...... S
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TABLE 8—CY 2018 STATUS INDICATORS FOR DRUG ADMINISTRATION SERVICES IN LEVEL 1 AND LEVEL 2 DRUG ADMINISTRATION APCS—Continued
CY 2018 HCPCS code Short descriptor status indicator
96371 ...... Sc ther infusion reset pump ...... Q1 96372 ...... Ther/proph/diag inj sc/im ...... Q1 96401 ...... Chemo anti-neopl sq/im ...... Q1 96402 ...... Chemo hormon antineopl sq/im ...... Q1 96405 ...... Chemo intralesional up to 7 ...... Q1 96411 ...... Chemo iv push addl drug ...... S 96415 ...... Chemo iv infusion addl hr ...... S 96417 ...... Chemo iv infus each addl seq ...... S
(3) Discussion of Comment Solicitation would create access to care issues or services are bundled into the cost of the Regarding Unconditionally Packaging have other unintended consequences. highest paying service and payment is Drug Administration Add-On Codes Specifically, we requested public made based on the highest single With respect to drug administration comments on the following: (1) Whether payable service. The stakeholder add-on codes, as discussed in the CY we should conditionally or requested that CMS create a pathology 2014 OPPS/ASC proposed rule (78 FR unconditionally package drug composite APC to more appropriately 43573), we proposed to unconditionally administration services add-on codes; pay for claims with only multiple package all drug administration services (2) how we should consider or pathology services and no other described by add-on codes. In response incorporate the varied clinical drug separately payable service such as a to the proposal, commenters objected to protocols that result in different surgical procedure or a clinic visit. The packaging drug administration add-on infusion times into a drug HOP panel recommended that CMS codes, which typically describe each administration service add-on code develop a composite APC for pathology additional hour of infusion or each payment proposal; and (3) other services when multiple pathology additional intravenous push, among recommendations on an encounter- services are provided on a claim with no others, in addition to the initial drug based payment approach for drug other payable services. The HOP Panel administration service. The commenters administration services that are also requested that CMS take into believed that such a policy could described by add-on codes when consideration the stakeholder disadvantage providers of longer drug furnished in the hospital outpatient presentation comments made at the administration services, which are often department setting. August 22, 2016 HOP Panel meeting protocol-driven and are not necessarily Comment: Many commenters raised regarding hospital pathology dictated by the hospital, but by the concerns about the appropriateness of laboratories as CMS evaluates characteristics of the specific drug or packaging drug administration services conditional packaging to determine biological being administered to the add-on codes, given the variation in whether an accommodation can be patient. In response to these comments, clinical treatment protocols. The made. Specifically, the stakeholder we stated in the CY 2014 OPPS/ASC commenters believed that packaging expressed concern with conditional final rule with comment period (78 FR drug administration services add-on packaging of pathology services, 74945) that, given the frequency of drug codes could create a barrier to access for particularly when payment is limited to administration services in the hospital drugs or biologicals with a long infusion the single highest paying code, outpatient department and their use in time. Without explicit incremental regardless of the number of services such a wide variety of different drug payment for additional hours of provided or specimens tested. treatment protocols for various diseases infusion, some commenters suggested In response to these HOP Panel in all types of hospitals, further study of hospitals could discontinue offering the requests and recommendation, we the payment methodology for these infusion. A few commenters suggested stated that we may consider the services was warranted at that time. that CMS consider the creation of a drug stakeholders’ request for a pathology Therefore, we did not finalize our administration C–APC for common drug composite APC as well as additional proposal to package the drug administration encounters but did not composite APCs for future rulemaking administration add-on codes in CY provide details on what specific services (81 FR 79588). In light of these requests 2014. However, we stated we would should comprise the C–APC. and recommendation, in development continue to explore other payment Response: We appreciate the of the CY 2018 OPPS/ASC proposed options, including packaging and comments we received on this topic and rule, we evaluated and considered a variations on packaging, in future years. will take them into consideration for pathology composite APC when In the CY 2018 OPPS/ASC proposed future rulemaking. multiple pathology services are rule, we did not propose to package performed and billed without a c. Analysis of Packaging of Pathology drug administration add-on codes for separately payable service on the same Services in the OPPS CY 2018 because we wanted stakeholder claim. To understand the frequency of input on a payment methodology that At the August 22, 2016 HOP Panel billing multiple pathology services and supports the principles of a prospective meeting, a stakeholder expressed no other separately payable codes on the payment system while ensuring patient concern regarding conditional same claim by hospital outpatient access to prolonged infusion services. packaging of multiple pathology departments, we examined currently Instead, we solicited public comment on services. When multiple conditionally available claims data to identify the whether conditionally or packaged services are billed on the same frequency distribution of pathology unconditionally packaging such codes claim, the costs of the lowest paying codes within the CPT code range 88300
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to 88361. The claim frequency the Internet on the CMS Web site) for some separate payment for individual breakdown was displayed in Table 8 of the CPT code descriptors. services or items while establishing the proposed rule (82 FR 33587). As we move toward larger payment incentives for efficiency through larger Based on our analysis of claims data bundles under the OPPS, the necessity units of payment. for the proposed rule, the majority of of composite APCs diminishes. For example, in the CY 2018 OPPS/ASC As the OPPS continues to move pathology only OPPS claims are toward prospectively determined reported with one pathology code. proposed rule, we proposed to delete encounter-based payments and away Therefore, as we stated in the CY 2018 composite APC 8001 (LDR Prostate from separate fee schedule-like OPPS/ASC proposed rule (82 FR 33588), Brachytherapy Composite) and to we believe that it is neither a frequent provide payment for the component payments, we continue to hear concerns occurrence nor a common occurrence procedures through the C–APC payment from stakeholders that our packaging for a provider to submit a claim for methodology. Composite APCs were a policies may be hampering patient payment under the OPPS with multiple precursor to C–APCs. In CY 2008, we access or resulting in other undesirable pathology services and no other implemented composite APCs to consequences. However, we have not separately payable service. provide a single payment for groups of observed significant fluctuations in our With regard to the HOP Panel’s services that are typically performed data that show a sharp decline of the recommendation to develop a composite together during a single clinical volume of packaged items and services, APC for pathology services when encounter and that result in the nor have we heard from Medicare multiple pathology services are provision of a complete service (72 FR beneficiaries specifically about access provided on a claim with no other 66650 through 66652). Because a C–APC issues or other concerns with packaged payable services, we used CY 2016 would treat all individually reported items and services. However, given that claims data available for the CY 2018 codes as representing components of the aggregate spending and utilization OPPS/ASC proposed rule to model four comprehensive service, all of the continue to increase for covered hypothetical pathology composite APCs. elements of the composite service are hospital outpatient services, it is unclear included in the C–APC payment. In That is, following our standard what, if any, adverse effect packaging addition, given the infrequent packaging methodology, we modeled has on beneficiary access to care. four hypothetical pathology composite occurrence of multiple pathology services on the same claim without a Specifically, in the CY 2018 OPPS/ASC APCs based on the following clinical proposed rule (82 FR 33588), within the scenarios that were specifically separately payable service, we do not believe a composite APC is necessary or framework of existing packaging requested by a stakeholder at the August categories, such as drugs that function 2016 HOP Panel meeting: warranted. • Therefore, for CY 2018, we did not as supplies in a surgical procedure or Hypothetical Composite APC A: propose to create a pathology composite diagnostic test or procedure, we Claims that contain 2–4 pathology units APC or additional composite APCs for expressed interest in stakeholder (CPT codes 88302 through 88309) with stakeholder-requested services, such as feedback on common clinical scenarios or without special stains (CPT codes X-ray services, respiratory services, involving currently packaged HCPCS 88312 through 88314); cardiology services, or allergy testing codes for which stakeholders believe • Hypothetical Composite APC B: services. However, we solicited public packaged payment is not appropriate Claims that contain 5 or more pathology comments on our packaging policies, as under the OPPS. Likewise, outside the units (CPT codes 88302 through 88309) discussed under section II.A.3.d. of this with or without special stains (CPT framework of existing packaging final rule with comment period. categories, we expressed interest in codes 88312 through 88314); We did not receive any public • stakeholder feedback on common Hypothetical Composite APC C: comments on our analysis of packaging clinical scenarios involving separately Claims that contain 2–4 pathology units of pathology services. (CPT codes 88302 through 88309) with payable HCPCS codes for which immunostains (CPT codes 88341, 88342, d. Summary of Public Comments and payment would be most appropriately 88346, 88350, 88360, 88361); and Our Responses Regarding Packaging of packaged under the OPPS. In the • Hypothetical Composite APC D: Items and Services Under the OPPS proposed rule, we solicited public Claims that contain 5 or more pathology As previously noted, packaging is an comments from a broad cross-section of units (CPT codes 88302 through 88309) inherent principle of a prospective stakeholders, including beneficiaries, with immunostains (CPT codes 88341, payment system. The OPPS, like other patient advocates, hospital providers, 88342, 88346, 88350, 88360, 88361). prospective payment systems, relies on clinicians, manufacturers, and other In addition, for the proposed rule, we the concept of averaging, where the interested parties. evaluated the volume of services and payment may be more or less than the Comment: Commenters expressed a costs for each hypothetical composite. estimated costs of providing a service or variety of views on packaging under the Results from modeling the four package of services for a particular OPPS. The comments ranged from composite scenarios showed low claim patient, but with the exception of outlier requests to unpackage most items and volume, which indicates that the cases, is adequate to ensure access to services that are either conditionally or suggested pathology code combinations appropriate care. Packaging and unconditionally packaged under the are infrequently billed by hospital bundling payments for multiple OPPS, including drugs and devices, to outpatient departments and which may interrelated services into a single specific requests to unpackage a specific mean that these are not likely clinical payment create incentives for providers drug or device. scenarios in hospital outpatient to furnish services in the most efficient departments. A summary of the results way by enabling hospitals to manage Response: We appreciate the from our composite analysis was their resources with maximum comments received and will review presented in Table 9 of the proposed flexibility, thereby encouraging long- them as we continue to explore and rule (82 FR 33587). We refer readers to term cost containment. Decisions about evaluate packaging policies that apply Addendum B to the CY 2018 OPPS/ASC packaging and bundling payment under the OPPS and take them into proposed rule (which is available via involve a balance between ensuring consideration for future rulemaking.
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4. Calculation of OPPS Scaled Payment for CY 2017, we proposed to assign APC link and open the claims accounting Weights 5012 a relative payment weight of 1.00 document link at the bottom of the page. We established a policy in the CY and to divide the geometric mean cost We proposed to compare the 2013 OPPS/ASC final rule with of each APC by the geometric mean cost estimated unscaled relative payment weights in CY 2018 to the estimated comment period (77 FR 68283) of using for APC 5012 to derive the unscaled total relative payment weights in CY geometric mean-based APC costs to relative payment weight for each APC. 2017 using CY 2016 claims data, calculate relative payment weights The choice of the APC on which to holding all other components of the under the OPPS. In the CY 2017 OPPS/ standardize the relative payment payment system constant to isolate ASC final rule with comment period (81 weights does not affect payments made changes in total weight. Based on this FR 79594 through 79595), we applied under the OPPS because we scale the comparison, we proposed to adjust the this policy and calculated the relative weights for budget neutrality. We did not receive any public calculated CY 2018 unscaled relative payment weights for each APC for CY comments on our proposal to use the payment weights for purposes of budget 2017 that were shown in Addenda A geometric mean cost of APC 5012 to neutrality. We proposed to adjust the and B to that final rule with comment standardize relative payment weights estimated CY 2018 unscaled relative period (which were made available via for CY 2018. Therefore, we are finalizing payment weights by multiplying them the Internet on the CMS Web site) using our proposal and assigning APC 5012 by a proposed weight scalar of 1.328 to the APC costs discussed in sections the relative payment weight of 1.00, and ensure that the proposed CY 2018 II.A.1. and II.A.2. of that final rule with using the relative payment weight for relative payment weights are scaled to comment period. For CY 2018, as we APC 5012 to derive the unscaled be budget neutral. The proposed CY did for CY 2017, we proposed to relative payment weight for each APC 2018 relative payment weights listed in continue to apply the policy established for CY 2018. Addenda A and B to the proposed rule in CY 2013 and calculate relative Section 1833(t)(9)(B) of the Act (which are available via the Internet on payment weights for each APC for CY requires that APC reclassification and the CMS Web site) were scaled and 2018 using geometric mean-based APC recalibration changes, wage index incorporated the recalibration costs (82 FR 33588). changes, and other adjustments be made adjustments discussed in sections II.A.1. For CY 2012 and CY 2013, outpatient in a budget neutral manner. Budget and II.A.2. of the proposed rule. clinic visits were assigned to one of five neutrality ensures that the estimated The final CY 2018 relative payment levels of clinic visit APCs, with APC aggregate weight under the OPPS for CY weights listed in Addenda A and B to 0606 representing a mid-level clinic 2018 is neither greater than nor less the final rule with comment period visit. In the CY 2014 OPPS/ASC final than the estimated aggregate weight that (which are available via the Internet on rule with comment period (78 FR 75036 would have been made without the the CMS Web site) were scaled and through 75043), we finalized a policy changes. To comply with this incorporate the recalibration that created alphanumeric HCPCS code requirement concerning the APC adjustments discussed in sections II.A.1. G0463 (Hospital outpatient clinic visit changes, in the CY 2018 OPPS/ASC and II.A.2. of this final rule with for assessment and management of a proposed rule (82 FR 33588), we comment period. patient), representing any and all clinic proposed to compare the estimated Section 1833(t)(14) of the Act visits under the OPPS. HCPCS code aggregate weight using the CY 2017 provides the payment rates for certain G0463 was assigned to APC 0634 scaled relative payment weights to the SCODs. Section 1833(t)(14)(H) of the (Hospital Clinic Visits). We also estimated aggregate weight using the Act provides that additional finalized a policy to use CY 2012 claims proposed CY 2018 unscaled relative expenditures resulting from this data to develop the CY 2014 OPPS payment weights. paragraph shall not be taken into payment rates for HCPCS code G0463 For CY 2017, we multiplied the CY account in establishing the conversion based on the total geometric mean cost 2017 scaled APC relative payment factor, weighting, and other adjustment of the levels one through five CPT E/M weight applicable to a service paid factors for 2004 and 2005 under codes for clinic visits previously under the OPPS by the volume of that paragraph (9), but shall be taken into recognized under the OPPS (CPT codes service from CY 2016 claims to calculate account for subsequent years. Therefore, 99201 through 99205 and 99211 through the total relative payment weight for the cost of those SCODs (as discussed in 99215). In addition, we finalized a each service. We then added together section V.B.2. of this final rule with policy to no longer recognize a the total relative payment weight for comment period) is included in the distinction between new and each of these services in order to budget neutrality calculations for the CY established patient clinic visits. calculate an estimated aggregate weight 2018 OPPS. For CY 2016, we deleted APC 0634 for the year. For CY 2018, we proposed We did not receive any public and reassigned the outpatient clinic to apply the same process using the comments on the proposed weight visit HCPCS code G0463 to APC 5012 estimated CY 2018 unscaled relative scalar calculation. Therefore, we are (Level 2 Examinations and Related payment weights rather than scaled finalizing our proposal to use the Services) (80 FR 70351). In the CY 2018 relative payment weights. We proposed calculation process described in the OPPS/ASC proposed rule (82 FR 33588), to calculate the weight scalar by proposed rule, without modification, for for CY 2018, as we did for CY 2017, we dividing the CY 2017 estimated CY 2018. Using updated final rule proposed to continue to standardize all aggregate weight by the unscaled CY claims data, we are updating the of the relative payment weights to APC 2018 estimated aggregate weight. estimated CY 2018 unscaled relative 5012. We stated that we believe that For a detailed discussion of the payment weights by multiplying them standardizing relative payment weights weight scalar calculation, we refer by a weight scalar of 1.4457 to ensure to the geometric mean of the APC to readers to the OPPS claims accounting that the final CY 2018 relative payment which HCPCS code G0463 is assigned document available on the CMS Web weights are scaled to be budget neutral. maintains consistency in calculating site at: http://www.cms.gov/Medicare/ unscaled weights that represent the cost Medicare-Fee-for-Service-Payment/ B. Conversion Factor Update of some of the most frequently provided HospitalOutpatientPPS/index.html. Section 1833(t)(3)(C)(ii) of the Act OPPS services. For CY 2018, as we did Click on the CY 2018 OPPS final rule requires the Secretary to update the
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conversion factor used to determine the are components in calculating the OPD schedule increase factor by the MFP payment rates under the OPPS on an fee schedule increase factor under adjustment as determined by CMS, and annual basis by applying the OPD fee sections 1833(t)(3)(C)(iv) and to reflect the requirement in section schedule increase factor. For purposes 1833(t)(3)(F) of the Act, in this CY 2018 1833(t)(3)(G)(v) of the Act, as required of section 1833(t)(3)(C)(iv) of the Act, OPPS/ASC final rule with comment by section 1833(t)(3)(F)(ii) of the Act, subject to sections 1833(t)(17) and period. Consistent with that proposal, that we reduce the OPD fee schedule 1833(t)(3)(F) of the Act, the OPD fee and the FY 2018 IPPS/LTCH PPS final increase factor by an additional 0.75 schedule increase factor is equal to the rule (82 FR 38177), we applied the final percentage point for CY 2018. hospital inpatient market basket FY 2018 market basket percentage We did not receive any public percentage increase applicable to increase (2.7 percent) and the final FY comments on our proposal. Therefore, hospital discharges under section 2018 MFP adjustment (0.6 percent) to we are implementing our proposal 1886(b)(3)(B)(iii) of the Act. As stated in the OPD fee schedule increase factor for without modification. the CY 2018 OPPS/ASC proposed rule, the CY 2018 OPPS. To set the OPPS conversion factor for in the FY 2018 IPPS/LTCH PPS In addition, section 1833(t)(3)(F)(ii) of the CY 2018 OPPS/ASC proposed rule, proposed rule (82 FR 19931), consistent the Act requires that, for each of years we proposed to increase the CY 2017 with current law, based on IHS Global, 2010 through 2019, the OPD fee conversion factor of $75.001 by 1.75 Inc.’s fourth quarter 2016 forecast of the schedule increase factor under section percent (82 FR 33589). In accordance FY 2018 market basket increase, the 1833(t)(3)(C)(iv) of the Act be reduced with section 1833(t)(9)(B) of the Act, we proposed FY 2018 IPPS market basket by the adjustment described in section proposed further to adjust the update was 2.9 percent. However, 1833(t)(3)(G) of the Act. For CY 2018, conversion factor for CY 2018 to ensure sections 1833(t)(3)(F) and section 1833(t)(3)(G)(v) of the Act that any revisions made to the wage 1833(t)(3)(G)(v) of the Act, as added by provides a 0.75 percentage point index and rural adjustment were made section 3401(i) of the Patient Protection reduction to the OPD fee schedule on a budget neutral basis. We proposed and Affordable Care Act of 2010 (Pub. increase factor under section to calculate an overall budget neutrality L. 111–148) and as amended by section 1833(t)(3)(C)(iv) of the Act. Therefore, in factor of 0.9999 for wage index changes 10319(g) of that law and further accordance with sections by comparing proposed total estimated amended by section 1105(e) of the 1833(t)(3)(F)(ii) and 1833(t)(3)(G)(v) of payments from our simulation model Health Care and Education the Act, in the CY 2018 OPPS/ASC using the proposed FY 2018 IPPS wage Reconciliation Act of 2010 (Pub. L. 111– proposed rule, we proposed to apply a indexes to those payments using the FY 152), provide adjustments to the OPD 0.75 percentage point reduction to the 2017 IPPS wage indexes, as adopted on fee schedule increase factor for CY 2018. OPD fee schedule increase factor for CY a calendar year basis for the OPPS. Specifically, section 1833(t)(3)(F)(i) of 2018. For the CY 2018 OPPS/ASC proposed the Act requires that, for 2012 and We note that section 1833(t)(3)(F) of rule, we proposed to maintain the subsequent years, the OPD fee schedule the Act provides that application of this current rural adjustment policy, as increase factor under subparagraph subparagraph may result in the OPD fee discussed in section II.E. of this final (C)(iv) be reduced by the productivity schedule increase factor under section rule with comment period. Therefore, adjustment described in section 1833(t)(3)(C)(iv) of the Act being less the proposed budget neutrality factor for 1886(b)(3)(B)(xi)(II) of the Act. Section than 0.0 percent for a year, and may the rural adjustment was 1.0000. 1886(b)(3)(B)(xi)(II) of the Act defines result in OPPS payment rates being less For the CY 2018 OPPS/ASC proposed the productivity adjustment as equal to than rates for the preceding year. As rule, we proposed to continue the 10-year moving average of changes described in further detail below, we are previously established policies for in annual economy-wide, private applying an OPD fee schedule increase implementing the cancer hospital nonfarm business multifactor factor of 1.35 percent for the CY 2018 payment adjustment described in productivity (MFP) (as projected by the OPPS (which is 2.7 percent, the final section 1833(t)(18) of the Act, as Secretary for the 10-year period ending estimate of the hospital inpatient market discussed in section II.F. of this final with the applicable fiscal year, year, basket percentage increase, less the final rule with comment period. We proposed cost reporting period, or other annual 0.6 percentage point MFP adjustment, to calculate a CY 2018 budget neutrality period) (the ‘‘MFP adjustment’’). In the and less the 0.75 percentage point adjustment factor for the cancer hospital FY 2012 IPPS/LTCH PPS final rule (76 additional adjustment). payment adjustment by comparing FR 51689 through 51692), we finalized Hospitals that fail to meet the estimated total CY 2018 payments under our methodology for calculating and Hospital OQR Program reporting section 1833(t) of the Act, including the applying the MFP adjustment, and then requirements are subject to an proposed CY 2018 cancer hospital revised this methodology as discussed additional reduction of 2.0 percentage payment adjustment, to estimated CY in the FY 2016 IPPS/LTCH PPS final points from the OPD fee schedule 2018 total payments using the CY 2017 rule (80 FR 49509). In the FY 2018 IPPS/ increase factor adjustment to the final cancer hospital payment LTCH PPS proposed rule (82 FR 19931 conversion factor that would be used to adjustment as required under section through 19932), the proposed MFP calculate the OPPS payment rates for 1833(t)(18)(B) of the Act. The CY 2018 adjustment for FY 2018 was 0.4 their services, as required by section proposed estimated payments applying percentage point. 1833(t)(17) of the Act. For further the proposed CY 2018 cancer hospital In the CY 2018 OPPS/ASC proposed discussion of the Hospital OQR payment adjustment were less than rule, we proposed that if more recent Program, we refer readers to section estimated payments applying the CY data became subsequently available XIII. of this final rule with comment 2017 final cancer hospital payment after the publication of the proposed period. adjustment. Therefore, we proposed to rule (for example, a more recent In the CY 2018 OPPS/ASC proposed apply a budget neutrality adjustment estimate of the market basket increase rule, we proposed to amend 42 CFR factor of 1.0003 to the conversion factor and the MFP adjustment), we would use 419.32(b)(1)(iv)(B) by adding a new for the cancer hospital payment such updated data, if appropriate, to paragraph (9) to reflect the requirement adjustment. In accordance with section determine the CY 2018 market basket in section 1833(t)(3)(F)(i) of the Act that, 16002(b) of the 21st Century Cures Act, update and the MFP adjustment, which for CY 2018, we reduce the OPD fee we stated in the proposed rule that we
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are applying a budget neutrality factor For CY 2018, we proposed to use a of approximately $1.6 billion into the calculated as if the proposed cancer conversion factor of $76.483 in the OPPS conversion factor, which results hospital adjustment target payment-to- calculation of the national unadjusted in a final adjustment of 1.0319 to the cost ratio was 0.90, not the 0.89 target payment rates for those items and OPPS conversion factor. payment-to-cost ratio we are applying as services for which payment rates are As a result of these finalized policies, stated in section II.F. of the proposed calculated using geometric mean costs; the OPD fee schedule increase factor for rule. that is, the proposed OPD fee schedule the CY 2018 OPPS is 1.35 percent For the CY 2018 OPPS/ASC proposed increase factor of 1.75 percent for CY (which is 2.7 percent, the estimate of the rule, we estimated that proposed pass- 2018, the required proposed wage index hospital inpatient market basket through spending for drugs, biologicals, budget neutrality adjustment of percentage increase, less the 0.6 and devices for CY 2018 would equal approximately 0.9999, the proposed percentage point MFP adjustment, and approximately $26.2 million, which cancer hospital payment adjustment of less the 0.75 percentage point additional represented 0.04 percent of total 1.0003, and the proposed adjustment of adjustment). For CY 2018, we are using projected CY 2018 OPPS spending. 0.22 percentage point of projected OPPS a conversion factor of $78.636 in the Therefore, the proposed conversion spending for the difference in the pass- calculation of the national unadjusted factor would be adjusted by the through spending and outlier payments payment rates for those items and difference between the 0.26 percent that resulted in a proposed conversion services for which payment rates are estimate of pass-through spending for factor for CY 2018 of $76.483. calculated using geometric mean costs; CY 2017 and the 0.04 percent estimate We invited public comments on these that is, the OPD fee schedule increase of proposed pass-through spending for proposals. However, we did not receive factor of 1.35 percent for CY 2018, the CY 2018, resulting in a proposed any public comments. Therefore, we are required wage index budget neutrality adjustment for CY 2018 of 0.22 percent. finalizing these proposals without adjustment of approximately 0.9997, the Proposed estimated payments for modification, as discussed below. cancer hospital payment adjustment of outliers would remain at 1.0 percent of For CY 2018, we proposed to continue 1.0008, the adjustment for drugs total OPPS payments for CY 2018. We previously established policies for purchased under the 340B Program of estimated for the proposed rule that implementing the cancer hospital 1.0319, and the adjustment of 0.2 outlier payments would be 1.04 percent payment adjustment described in percentage point of projected OPPS of total OPPS payments in CY 2017; the section 1833(t)(18) of the Act, as spending for the difference in the pass- 1.0 percent for proposed outlier discussed in section II.F. of this final through spending and outlier payments payments in CY 2018 would constitute rule with comment period. Based on the that result in a conversion factor for CY a 0.04 percent decrease in payment in updated claims data for this final rule 2018 of $78.636. CY 2018 relative to CY 2017. with comment period used in For the CY 2018 OPPS/ASC proposed calculating the cancer hospital payment C. Wage Index Changes rule, we also proposed that hospitals adjustment in section II.F. of this final Section 1833(t)(2)(D) of the Act that fail to meet the reporting rule with comment period, the target requires the Secretary to determine a requirements of the Hospital OQR PCR for the cancer hospital payment wage adjustment factor to adjust the Program would continue to be subject to adjustment, which was 0.91 for CY portion of payment and coinsurance a further reduction of 2.0 percentage 2017, is 0.88 for CY 2018. Because we attributable to labor-related costs for points to the OPD fee schedule increase budget neutralize using the target PCR relative differences in labor and labor- factor. For hospitals that fail to meet the ratio prior to implementation of section related costs across geographic regions requirements of the Hospital OQR 16002 (b) of the 21st Century Cures Act, in a budget neutral manner (codified at Program, we proposed to make all other we are applying a budget neutrality 42 CFR 419.43(a)). This portion of the adjustments discussed above, but use a adjustment factor of 1.0008 to the OPPS payment rate is called the OPPS reduced OPD fee schedule update factor conversion factor for the cancer hospital labor-related share. Budget neutrality is of ¥0.25 percent (that is, the proposed payment adjustment for CY 2018. discussed in section II.B. of this final OPD fee schedule increase factor of 1.75 In the CY 2018 OPPS/ASC proposed rule with comment period. percent further reduced by 2.0 rule (82 FR 33712), we estimated a 1.4 The OPPS labor-related share is 60 percentage points). This would result in percent adjustment to nondrug OPPS percent of the national OPPS payment. a proposed reduced conversion factor payment rates as a result of the This labor-related share is based on a for CY 2018 of $74.953 for hospitals that proposed payment adjustment to regression analysis that determined that, fail to meet the Hospital OQR Program separately payable nonpass-through for all hospitals, approximately 60 requirements (a difference of ¥1.530 in drugs purchased under the 340B percent of the costs of services paid the conversion factor relative to Program. As part of that proposed under the OPPS were attributable to hospitals that met the requirements). policy, we noted that our adjustment in wage costs. We confirmed that this In summary, for CY 2018, we the final rule could potentially change labor-related share for outpatient proposed to amend § 419.32(b)(1)(iv)(B) as a result of changes such as updated services is appropriate during our by adding a new paragraph (9) to reflect data, modifications to the estimate regression analysis for the payment the reductions to the OPD fee schedule methodology, and other factors. adjustment for rural hospitals in the CY increase factor that are required for CY Applying the final payment policy for 2006 OPPS final rule with comment 2018 to satisfy the statutory drugs purchased under the 340B period (70 FR 68553). In the CY 2018 requirements of sections 1833(t)(3)(F) Program, as described in section V.B.7. OPPS/ASC proposed rule (82 FR 33590), and (t)(3)(G)(v) of the Act. We proposed of this final rule with comment period, we proposed to continue this policy for to use a reduced conversion factor of results in an estimated reduction of the CY 2018 OPPS. We refer readers to $74.953 in the calculation of payments approximately $1.6 billion in separately section II.H. of this final rule with for hospitals that fail to meet the paid OPPS drug payments. To ensure comment period for a description and Hospital OQR Program requirements (a budget neutrality under the OPPS after an example of how the wage index for difference of ¥1.530 in the conversion applying this alternative payment a particular hospital is used to factor relative to hospitals that met the methodology for drugs purchased under determine payment for the hospital. We requirements). the 340B Program, we applied an offset did not receive any public comments on
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this proposal. Therefore, for the reasons neutrality) is less than 1.00 (as continue to reflect a number of discussed above and in the CY 2018 discussed below and in the CY 2018 adjustments implemented over the past OPPS/ASC proposed rule (82 FR 33590), OPPS/ASC proposed rule (82 FR 33591 few years, including, but not limited to, we are finalizing our proposal to through 33592)), we proposed not to reclassification of hospitals to different continue this policy as discussed above extend the imputed floor under the geographic areas, the rural floor for the CY 2018 OPPS without OPPS for CY 2018 and subsequent provisions, an adjustment for modification. years, consistent with our proposal in occupational mix, and an adjustment to As discussed in the claims accounting the FY 2018 IPPS/LTCH PPS proposed the wage index based on commuting narrative included with the supporting rule (81 FR 19904 through 19905) not to patterns of employees (the out-migration documentation for this final rule with extend the imputed floor under the IPPS adjustment). In the CY 2018 OPPS/ASC comment period (which is available via for FY 2018 and subsequent fiscal proposed rule, we referred readers to the the Internet on the CMS Web site), for years). Because the HOPD receives a FY 2018 IPPS/LTCH PPS proposed rule estimating APC costs, we standardize 60 wage index based on the geographic (82 FR 19898 through 19915) for a percent of estimated claims costs for location of the specific inpatient detailed discussion of all proposed geographic area wage variation using the hospital with which it is associated, we changes to the FY 2018 IPPS wage same FY 2018 pre-reclassified wage stated that the frontier State wage index indexes. We note that, in the FY 2018 index that the IPPS uses to standardize adjustment applicable for the inpatient IPPS/LTCH PPS proposed rule (82 FR costs. This standardization process hospital also would apply for any 19905), we proposed not to apply the removes the effects of differences in area associated HOPD. In the proposed rule imputed floor to the IPPS wage index wage levels from the determination of a (82 FR 33591), we referred readers to the computations for FY 2018 and national unadjusted OPPS payment rate FY 2011 through FY 2017 IPPS/LTCH subsequent fiscal years. Consistent with and copayment amount. PPS final rules for discussions regarding this, we proposed in the CY 2018 OPPS/ Under 42 CFR 419.41(c)(1) and this provision, including our ASC proposed rule (82 FR 33592) not to 419.43(c) (published in the OPPS April methodology for identifying which areas extend the imputed floor policy under 7, 2000 final rule with comment period meet the definition of ‘‘frontier States’’ the OPPS beyond December 31, 2017 (65 FR 18495 and 18545)), the OPPS as provided for in section (the date the imputed floor policy is set adopted the final fiscal year IPPS post- 1886(d)(3)(E)(iii)(II) of the Act. We to expire under the OPPS). However, in reclassified wage index as the calendar invited public comments on this the FY 2018 IPPS/LTCH PPS final rule, year wage index for adjusting the OPPS proposal. we did not finalize our proposal to standard payment amounts for labor We did not receive any public discontinue the imputed floor under the market differences. Therefore, the wage comments on this proposal. Therefore, IPPS, and instead decided to index that applies to a particular acute for the reasons discussed above and in temporarily extend the imputed floor for care, short-stay hospital under the IPPS the CY 2018 OPPS/ASC proposed rule an additional year through FY 2018, also applies to that hospital under the (82 FR 33591), we are finalizing our while we continue to assess the effects OPPS. As initially explained in the proposal to implement the frontier State of this policy and whether to continue September 8, 1998 OPPS proposed rule floor under the OPPS in the same or discontinue the imputed floor for the (63 FR 47576), we believe that using the manner as we have since CY 2011. We long term. As discussed below, IPPS wage index as the source of an note that, after we made our proposal in consistent with the FY 2018 IPPS/LTCH adjustment factor for the OPPS is the FY 2018 IPPS/LTCH PPS proposed PPS final rule, we are not finalizing our reasonable and logical, given the rule not to extend the imputed floor proposal to discontinue application of inseparable, subordinate status of the under the IPPS for FY 2018 and the imputed floor under the OPPS, but HOPD within the hospital overall. In subsequent fiscal years (82 FR 19904 are instead continuing the imputed floor accordance with section 1886(d)(3)(E) of through 19905), and our proposal in the policy under the OPPS for an additional the Act, the IPPS wage index is updated CY 2018 OPPS/ASC proposed rule not year, through December 31, 2018. We annually. to extend the imputed floor under the refer readers to the FY 2018 IPPS/LTCH The Affordable Care Act contained OPPS for CY 2018 and subsequent years PPS proposed and final rules (82 FR several provisions affecting the wage (82 FR 33592), we decided in the FY 19898 through 19915 and 82 FR 38129 index. These provisions were discussed 2018 IPPS/LTCH PPS final rule not to through 38157, respectively) for a in the CY 2012 OPPS/ASC final rule finalize our proposal to discontinue the detailed discussion of all proposed and with comment period (76 FR 74191). imputed floor under the IPPS (82 FR final changes to the FY 2018 IPPS wage Section 10324 of the Affordable Care 38138 through 38142). As discussed indexes (including our proposed and Act added section 1886(d)(3)(E)(iii)(II) below, consistent with the FY 2018 final policy regarding the imputed floor to the Act, which defines a frontier State IPPS/LTCH PPS final rule, we are not for FY 2018 and subsequent fiscal and amended section 1833(t) of the Act finalizing our proposal to discontinue years). In addition, we refer readers to to add paragraph (19), which requires a application of the imputed floor under the CY 2005 OPPS final rule with frontier State wage index floor of 1.00 in the OPPS. This means that the comment period (69 FR 65842 through certain cases, and states that the frontier applicable wage index, which can be 65844) and subsequent OPPS rules for a State floor shall not be applied in a superseded by the frontier State wage detailed discussion of the history of budget neutral manner. We codified index if the applicable criteria are met, these wage index adjustments as these requirements at § 419.43(c)(2) and could also be affected by the imputed applied under the OPPS. (3) of our regulations. For the CY 2018 floor. We discuss our policy on the Summarized below are comments we OPPS, we proposed to implement this extension of the imputed floor under the received regarding the application of the provision in the same manner as we IPPS as finalized in the FY 2018 IPPS/ rural and imputed floor policies under have since CY 2011 (82 FR 33591). LTCH PPS final rule (82 FR 38142), and the OPPS, along with our responses. Under this policy, the frontier State under the OPPS as finalized in this rule, Comment: One commenter opposed hospitals would receive a wage index of in more detail later in this section. applying budget neutrality for the rural 1.00 if the otherwise applicable wage In addition to the changes required by floor under the OPPS on a national index (including reclassification, the the Affordable Care Act, we note that basis. The commenter believed applying rural floor, and rural floor budget the FY 2018 IPPS wage indexes budget neutrality on a national basis
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disadvantages hospitals in most States extend the imputed floor policy under not finalizing our proposal to while benefiting hospitals in a few the OPPS beyond December 31, 2017 discontinue the imputed floor policy States that have taken advantage of the (the date the imputed floor policy is set under the OPPS. We continue to believe system where a rural hospital has a to expire under the OPPS). As discussed that using the final fiscal year IPPS post- wage index higher than most or all in the FY 2018 IPPS/LTCH PPS final reclassified wage index, inclusive of any urban hospitals in a State. The rule (82 FR 38138 through 38142), after adjustments (including the imputed commenter stated that rural floor budget consideration of the many comments we floor), as the wage index for the OPPS neutrality currently requires all wage received both in support of and against to determine the wage adjustments for indexes for hospitals throughout the our proposal to discontinue the imputed both the OPPS payment rate and the nation to be reduced. However, floor under the IPPS, we decided to copayment standardized amount is hospitals in those States that have temporarily extend the imputed floor for reasonable and logical, given the higher wage indexes because of the rural an additional year under the IPPS inseparable, subordinate status of the floor are not substantially affected by through FY 2018, while we continue to HOPD within the hospital overall. the wage index reductions. Therefore, assess the effects of this policy and As discussed in the FY 2015 IPPS/ the commenter supported calculating whether to continue or discontinue the LTCH PPS final rule (79 FR 49951 rural floor budget neutrality under the imputed floor for the long term. through 49963), the FY 2016 IPPS/LTCH OPPS for each individual State. Therefore, in the FY 2018 IPPS/LTCH PPS final rule (80 FR 49488 through Response: We appreciate this PPS final rule, we extended the imputed 49489 and 49494 through 49496), and comment. We acknowledge that the floor policy under both the original the FY 2017 IPPS/LTCH PPS final rule application of the wage index and methodology and the alternative (81 FR 56913), the Office of applicable wage index adjustments to methodology for an additional year, Management and Budget (OMB) issued OPPS payment rates may create through September 30, 2018. We refer revisions to the labor market area distributional payment variations, readers to the FY 2018 IPPS/LTCH PPS delineations on February 28, 2013 especially within a budget neutral final rule (82 FR 38138 through 38142) (based on 2010 Decennial Census data), system. However, we continue to for a detailed discussion of our final that included a number of significant believe it is reasonable and appropriate policy and rationale regarding changes such as new Core Based to continue the current policy of application of the imputed floor under Statistical Areas (CBSAs), urban applying budget neutrality for the rural the IPPS for FY 2018. Given the counties that became rural, rural floor under the OPPS on a national inseparable, subordinate status of the counties that became urban, and basis, consistent with the IPPS. We HOPD within the hospital overall, we existing CBSAs that were split apart believe that hospital inpatient and believe that using the IPPS wage index (OMB Bulletin 13–01). This bulletin can outpatient departments are subject to and wage index adjustments, including be found at: https:// the same labor cost environment, and the imputed floor, as the source of an obamawhitehouse.archives.gov/sites/ therefore, the wage index and any adjustment factor for the OPPS is default/files/omb/bulletins/2013/b13- applicable wage index adjustments reasonable and logical. Furthermore, as 01.pdf. In the FY 2015 IPPS/LTCH PPS (including the rural floor and rural floor we previously stated, we believe that final rule (79 FR 49950 through 49985), budget neutrality) should be applied in hospital inpatient and outpatient we adopted the use of the OMB labor the same manner under the IPPS and departments are subject to the same market area delineations contained in OMB Bulletin No. 13–01, effective OPPS. Furthermore, we believe that labor cost environment and, therefore, applying the rural floor and rural floor October 1, 2014. In the FY 2017 IPPS/ the wage index and any applicable wage budget neutrality in the same manner LTCH PPS final rule (81 FR 56913), we index adjustments (including the under the IPPS and OPPS is reasonable adopted revisions to statistical areas imputed floor) should be applied in the and logical, given the inseparable, contained in OMB Bulletin No. 15–01, same manner under the IPPS and OPPS. subordinate status of the HOPD within issued on July 15, 2015, which provided In addition, as discussed above, we the hospital overall. In addition, we updates to and superseded OMB believe the application of different wage believe the application of different wage Bulletin No. 13–01 that was issued on index adjustments under the IPPS and indexes and wage index adjustments February 28, 2013. We believe that it is OPPS would add a level of under the IPPS and OPPS would add a important for the OPPS to use the latest administrative complexity that is overly level of administrative complexity that labor market area delineations available is overly burdensome and unnecessary. burdensome and unnecessary. Thus, as as soon as is reasonably possible in Therefore, we are continuing the current discussed further below, consistent with order to maintain a more accurate and policy of applying budget neutrality for the FY 2018 IPPS/LTCH PPS final rule, up-to-date payment system that reflects the rural floor under the OPPS on a we are not finalizing our proposal to the reality of population shifts and labor national basis, consistent with the IPPS. discontinue application of the imputed market conditions. Therefore, for Comment: One commenter supported floor under the OPPS, and instead are purposes of the OPPS, in the CY 2017 the proposal to not apply the imputed temporarily extending the imputed floor OPPS/ASC final rule with comment floor to the IPPS wage index policy under the OPPS for an additional period (81 FR 79598), we adopted the computations for FY 2018 and year. revisions to the OMB statistical area subsequent fiscal years when After consideration of the public delineations contained in OMB Bulletin calculating the hospital wage indexes comments we received and for the No. 15–01, effective January 1, 2017, for the OPPS. reasons discussed above, consistent beginning with the CY 2017 OPPS wage Response: In the FY 2018 IPPS/LTCH with the FY 2018 IPPS/LTCH PPS final indexes. PPS proposed rule (82 FR 19905), we rule, we have decided to extend the CBSAs are made up of one or more proposed not to apply the imputed floor imputed floor policy under the OPPS for constituent counties. Each CBSA and to the IPPS wage index computations for an additional year, through December constituent county has its own unique FY 2018 and subsequent fiscal years. 31, 2018, while we continue to assess identifying codes. The FY 2018 IPPS/ Consistent with this proposal, we the effects of this policy and whether to LTCH PPS proposed rule (82 FR 19898 proposed in the CY 2018 OPPS/ASC continue or discontinue the imputed through 19899) and final rule (82 FR proposed rule (82 FR 33592) not to floor for the long term. Therefore, we are 38130) discuss the two different lists of
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codes to identify counties: Social LTCH PPS final rule. Based on Hospitals File posted on the CMS Web Security Administration (SSA) codes information included in the Census site reflect these county changes. and Federal Information Processing Bureau’s Web site, since 2010, the In the CY 2018 OPPS/ASC proposed Standard (FIPS) codes. Historically, Census Bureau has made the following rule (82 FR 33592), we proposed to use CMS has listed and used SSA and FIPS updates to the FIPS codes for counties the FY 2018 hospital IPPS post- county codes to identify and crosswalk or county equivalent entities: reclassified wage index for urban and counties to CBSA codes for purposes of • Petersburg Borough, AK (FIPS State rural areas as the wage index for the the IPPS and OPPS wage indexes. County Code 02–195), CBSA 02, was OPPS to determine the wage However, the SSA county codes are no created from part of former Petersburg adjustments for both the OPPS payment longer being maintained and updated, Census Area (02–195) and part of rate and the copayment standardized although the FIPS codes continue to be Hoonah-Angoon Census Area (02–105). amount for CY 2018. Therefore, we maintained by the U.S. Census Bureau. The CBSA code remains 02. stated in the proposed rule that any • The Census Bureau’s most current The name of La Salle Parish, LA adjustments for the FY 2018 IPPS post- statistical area information is derived (FIPS State County Code 22–059), CBSA reclassified wage index would be from ongoing census data received since 14, is now LaSalle Parish, LA (FIPS reflected in the final CY 2018 OPPS 2010; the most recent data are from State County Code 22–059). The CBSA wage index. (We refer readers to the FY code remains as 14. 2018 IPPS/LTCH PPS proposed rule (82 2015. In the FY 2018 IPPS/LTCH PPS • proposed rule (81 FR 19898), for The name of Shannon County, SD FR 19898 through 19915) and final rule purposes of crosswalking counties to (FIPS State County Code 46–113), CBSA (82 FR 38129 through 38157), and the CBSAs for the IPPS wage index, we 43, is now Oglala Lakota County, SD proposed and final FY 2018 hospital proposed to discontinue the use of the (FIPS State County Code 46–102). The wage index files posted on the CMS SSA county codes and begin using only CBSA code remains as 43. Web site.) We invited public comments In the FY 2018 IPPS/LTCH PPS final the FIPS county codes. (We note that we on this proposal. As discussed above, rule (82 FR 38130), for the IPPS, we finalized the proposal to discontinue we received public comments regarding finalized our proposal to implement use of SSA county codes and begin the application of the rural and imputed these FIPS code updates, effective using only the FIPS county codes for floors under the OPPS. We refer readers October 1, 2017, beginning with the FY to our earlier discussion of these purposes of crosswalking counties to 2018 wage indexes. We note that while CBSAs in the FY 2018 IPPS/LTCH PPS comments and our responses. After the county update changes listed earlier consideration of these comments, for the final rule (82 FR 38130)). Similarly, for changed the county names, the CBSAs the purposes of crosswalking counties to reasons discussed above and in the CY to which these counties map did not 2018 OPPS/ASC proposed rule (82 FR CBSAs for the OPPS wage index, in the change from the prior counties. CY 2018 OPPS/ASC proposed rule (82 33592), we are finalizing this proposal Therefore, there is no impact or change without modification. As stated earlier, FR 33591), we proposed to discontinue to hospitals in these counties; they the use of SSA county codes and begin we continue to believe that using the continue to be considered rural for the final fiscal year IPPS post-reclassified using only the FIPS county codes. We IPPS wage index under these changes. invited public comments on this wage index, inclusive of any Consistent with the FY 2018 IPPS/LTCH adjustments, as the wage index for the proposal. We did not receive any public PPS proposed rule, in the CY 2018 comments on this proposal. Thus, for OPPS to determine the wage OPPS/ASC proposed rule (82 FR 33592), adjustments for both the OPPS payment the reasons discussed above and in the we proposed to implement these rate and the copayment standardized CY 2018 OPPS/ASC proposed rule (82 revisions for purposes of the OPPS, amount is reasonable and logical, given FR 33591), we are finalizing, without effective January 1, 2018, beginning the inseparable, subordinate status of modification, our proposal to with the CY 2018 OPPS wage indexes. the HOPD within the hospital overall. discontinue the use of SSA county We stated that we believe it is important Hospitals that are paid under the codes and begin using only the FIPS to use the latest counties or county OPPS, but not under the IPPS, do not county codes for the purposes of equivalent entities in order to properly have an assigned hospital wage index crosswalking counties to CBSAs for the crosswalk hospitals from a county to a under the IPPS. Therefore, for non-IPPS OPPS wage index. CBSA for purposes of the OPPS wage hospitals paid under the OPPS, it is our The Census Bureau maintains a index. In addition, we stated we believe longstanding policy to assign the wage complete list of changes to counties or that using the latest FIPS codes will index that would be applicable if the county equivalent entities on the Web allow us to maintain a more accurate hospital were paid under the IPPS, site at: https://www.census.gov/geo/ and up-to-date payment system that based on its geographic location and any reference/county-changes.html. In our reflects the reality of population shifts applicable wage index adjustments. In proposed transition to using only FIPS and labor market conditions. We invited the CY 2018 OPPS/ASC proposed rule, codes for counties for the IPPS wage public comments on this proposal. we proposed to continue this policy for index, in the FY 2018 IPPS/LTCH PPS We did not receive any public CY 2018, and included a brief summary proposed rule (82 FR 19899), we comments on this proposal. Therefore, of the major proposed FY 2018 IPPS proposed to update the FIPS codes used for the reasons discussed above and in wage index policies and adjustments for crosswalking counties to CBSAs for the CY 2018 OPPS/ASC proposed rule that we proposed to apply to these the IPPS wage index effective October 1, (82 FR 33591 through 33592), we are hospitals under the OPPS for CY 2018. 2017, to incorporate changes to the finalizing our proposal, without These proposals are summarized below. counties or county equivalent entities modification, to implement the FIPS We invited public comments on these included in the Census Bureau’s most code updates described above, effective proposals. recent list. We proposed to include January 1, 2018, beginning with the CY It has been our longstanding policy to these updates to calculate the area wage 2018 OPPS wage indexes. Tables 2 and allow non-IPPS hospitals paid under the indexes in a manner that is generally 3 associated with the FY 2018 IPPS/ OPPS to qualify for the out-migration consistent with the CBSA-based LTCH PPS final rule and the County to adjustment if they are located in a methodologies finalized in the FY 2005 CBSA Crosswalk File and Urban CBSAs section 505 out-migration county IPPS final rule and the FY 2015 IPPS/ and Constituent Counties for Acute Care (section 505 of the Medicare
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Prescription Drug, Improvement, and with the FY 2018 IPPS/LTCH PPS final adjustment under the CY 2018 OPPS. Modernization Act of 2003 (MMA)). rule, as discussed above, we are Addendum L is available via the Applying this adjustment is consistent extending the imputed floor policy Internet on the CMS Web site. We refer with our policy of adopting IPPS wage under the OPPS for one additional year, readers to the CMS Web site for the index policies for hospitals paid under through December 31, 2018. Therefore, OPPS at: http://www.cms.gov/Medicare/ the OPPS. We note that, because non- for CY 2018, for hospitals paid under Medicare-Fee-for-Service-Payment/ IPPS hospitals cannot reclassify, they the OPPS but not under the IPPS, the HospitalOutpatientPPS/index.html. At are eligible for the out-migration wage imputed floor policy will continue to this link, readers will find a link to the adjustment if they are located in a apply through December 31, 2018. final FY 2018 IPPS wage index tables section 505 out-migration county. This For CMHCs, for CY 2018, we and Addendum L. is the same out-migration adjustment proposed to continue to calculate the policy that applies if the hospital were wage index by using the post- D. Statewide Average Default CCRs paid under the IPPS. For CY 2018, we reclassification IPPS wage index based In addition to using CCRs to estimate proposed to continue our policy of on the CBSA where the CMHC is costs from charges on claims for allowing non-IPPS hospitals paid under located. As with OPPS hospitals and for ratesetting, CMS uses overall hospital- the OPPS to qualify for the out- the same reasons, for CMHCs previously specific CCRs calculated from the migration adjustment if they are located located in urban CBSAs that were hospital’s most recent cost report to in a section 505 out-migration county designated as rural under the revised determine outlier payments, payments (section 505 of the MMA). We did not OMB labor market area delineations in for pass-through devices, and monthly receive any public comments on this OMB Bulletin No. 13–01, we finalized a interim transitional corridor payments proposal. Therefore, for the reasons policy to maintain the urban wage index under the OPPS during the PPS year. discussed above and in the CY 2018 value of the CBSA in which they were MACs cannot calculate a CCR for some OPPS/ASC proposed rule (82 FR 33592), physically located for CY 2014 for 3 hospitals because there is no cost report we are finalizing this proposal without calendar years (until December 31, available. For these hospitals, CMS uses modification. 2017). Because this 3-year transition the statewide average default CCRs to As stated earlier, in the FY 2015 IPPS/ will end at the end of CY 2017, it will determine the payments mentioned LTCH PPS final rule, we adopted the not be applied in CY 2018. Furthermore, earlier until a hospital’s MAC is able to OMB labor market area delineations in the CY 2018 OPPS/ASC proposed calculate the hospital’s actual CCR from issued by OMB in OMB Bulletin No. rule (82 FR 33592), we proposed that its most recently submitted Medicare 13–01 on February 28, 2013, based on the wage index that applies to CMHCs cost report. These hospitals include, but standards published on June 28, 2010 would include the rural floor are not limited to, hospitals that are (75 FR 37246 through 37252) and the adjustment, but not the imputed floor new, hospitals that have not accepted 2010 Census data to delineate labor adjustment, given that we had proposed assignment of an existing hospital’s market areas for purposes of the IPPS not to extend the imputed floor policy provider agreement, and hospitals that wage index. For IPPS wage index under the OPPS beyond December 31, have not yet submitted a cost report. purposes, for hospitals that were located 2017 (the expiration date for the CMS also uses the statewide average in urban CBSAs in FY 2014 but were imputed floor under the OPPS). We also default CCRs to determine payments for designated as rural under these revised proposed that the wage index that hospitals that appear to have a biased OMB labor market area delineations, we applies to CMHCs would not include CCR (that is, the CCR falls outside the generally assigned them the urban wage the out-migration adjustment because predetermined ceiling threshold for a index value of the CBSA in which they that adjustment only applies to valid CCR) or for hospitals in which the were physically located for FY 2014 for hospitals. We did not receive any public most recent cost report reflects an all- a period of 3 fiscal years (79 FR 49957 comments regarding these proposals, inclusive rate status (Medicare Claims through 49960). To be consistent, we and are finalizing these proposals with applied the same policy to hospitals the following modification. Because, as Processing Manual (Pub. 100–04), paid under the OPPS but not under the discussed above, we are extending the Chapter 4, Section 10.11). IPPS so that such hospitals will application of the imputed floor under In the CY 2018 OPPS/ASC proposed maintain the wage index of the CBSA in the OPPS for an additional year, through rule (82 FR 33593), we proposed to which they were physically located for December 31, 2018, the wage index that update the default ratios for CY 2018 FY 2014 for 3 calendar years (until applies to CMHCs will continue to using the most recent cost report data. December 31, 2017). Because this 3-year include the imputed floor adjustment We discussed our policy for using transition will end at the end of CY through December 31, 2018. default CCRs, including setting the 2017, it will no longer be applied in CY Table 2 associated with the FY 2018 ceiling threshold for a valid CCR, in the 2018. IPPS/LTCH PPS final rule (available via CY 2009 OPPS/ASC final rule with In addition, under the IPPS, the the Internet on the CMS Web site at: comment period (73 FR 68594 through imputed floor policy was set to expire http://www.cms.gov/Medicare/ 68599) in the context of our adoption of effective October 1, 2017. However, as Medicare-Fee-for-Service-Payment/ an outlier reconciliation policy for cost discussed above and in the FY 2018 AcuteInpatientPPS/index.html) reports beginning on or after January 1, IPPS/LTCH PPS final rule (82 FR 38138 identifies counties eligible for the out- 2009. For detail on our process for through 38142), we did not finalize our migration adjustment and IPPS calculating the statewide average CCRs, proposal not to extend the imputed floor hospitals that will receive the we referred readers to the CY 2018 policy under the IPPS for FY 2018 and adjustment for FY 2018. We are OPPS proposed rule Claims Accounting subsequent fiscal years (82 FR 38132), including the out-migration adjustment Narrative that is posted on the CMS and instead decided to extend the information from Table 2 associated Web site. Table 10 published in the imputed floor policy for one additional with the FY 2018 IPPS/LTCH PPS final proposed rule (82 FR 33593 through year, through FY 2018. For purposes of rule as Addendum L to this final rule 33594) listed the proposed statewide the CY 2018 OPPS, we proposed not to with comment period with the addition average default CCRs for OPPS services extend the imputed floor policy beyond of non-IPPS hospitals that will receive furnished on or after January 1, 2018, December 31, 2017. However, consistent the section 505 out-migration based on proposed rule data.
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We did not receive any public charges to costs on claims data for Table 9 below lists the statewide comments on our proposal to use setting the final CY 2018 OPPS relative average default CCRs for OPPS services statewide average default CCRs if a payment weights. Therefore, we are furnished on or after January 1, 2018, MAC cannot calculate a CCR for a finalizing our proposal without based on final rule data. hospital and to use these CCRs to adjust modification.
TABLE 9—CY 2018 STATEWIDE AVERAGE CCRS
Previous default CCR State Urban/rural CY 2018 (CY 2017 default CCR OPPS final rule)
ALASKA ...... RURAL ...... 0.659 0.449 ALASKA ...... URBAN ...... 0.218 0.237 ALABAMA ...... RURAL ...... 0.190 0.196 ALABAMA ...... URBAN ...... 0.155 0.158 ARKANSAS ...... RURAL ...... 0.186 0.196 ARKANSAS ...... URBAN ...... 0.200 0.205 ARIZONA ...... RURAL ...... 0.232 0.238 ARIZONA ...... URBAN ...... 0.160 0.176 CALIFORNIA ...... RURAL ...... 0.181 0.179 CALIFORNIA ...... URBAN ...... 0.193 0.188 COLORADO ...... RURAL ...... 0.346 0.354 COLORADO ...... URBAN ...... 0.204 0.208 CONNECTICUT ...... RURAL ...... 0.324 0.402 CONNECTICUT ...... URBAN ...... 0.249 0.253 DISTRICT OF COLUMBIA ...... URBAN ...... 0.279 0.286 DELAWARE ...... URBAN ...... 0.295 0.288 FLORIDA ...... RURAL ...... 0.158 0.169 FLORIDA ...... URBAN ...... 0.138 0.143 GEORGIA ...... RURAL ...... 0.222 0.230 GEORGIA ...... URBAN ...... 0.198 0.196 HAWAII ...... RURAL ...... 0.332 0.338 HAWAII ...... URBAN ...... 0.322 0.319 IOWA ...... RURAL ...... 0.296 0.291 IOWA ...... URBAN ...... 0.254 0.252 IDAHO ...... RURAL ...... 0.339 0.341 IDAHO ...... URBAN ...... 0.369 0.401 ILLINOIS ...... RURAL ...... 0.214 0.241 ILLINOIS ...... URBAN ...... 0.208 0.209 INDIANA ...... RURAL ...... 0.299 0.272 INDIANA ...... URBAN ...... 0.213 0.218 KANSAS ...... RURAL ...... 0.264 0.269 KANSAS ...... URBAN ...... 0.199 0.194 KENTUCKY ...... RURAL ...... 0.184 0.194 KENTUCKY ...... URBAN ...... 0.187 0.189 LOUISIANA ...... RURAL ...... 0.212 0.217 LOUISIANA ...... URBAN ...... 0.195 0.201 MASSACHUSETTS ...... RURAL ...... 0.322 0.316 MASSACHUSETTS ...... URBAN ...... 0.348 0.345 MAINE ...... RURAL ...... 0.419 0.425 MAINE ...... URBAN ...... 0.422 0.413 MARYLAND ...... RURAL ...... 0.258 0.264 MARYLAND ...... URBAN ...... 0.227 0.229 MICHIGAN ...... RURAL ...... 0.302 0.295 MICHIGAN ...... URBAN ...... 0.318 0.324 MINNESOTA ...... RURAL ...... 0.379 0.398 MINNESOTA ...... URBAN ...... 0.302 0.319 MISSOURI ...... RURAL ...... 0.220 0.222 MISSOURI ...... URBAN ...... 0.240 0.261 MISSISSIPPI ...... RURAL ...... 0.213 0.224 MISSISSIPPI ...... URBAN ...... 0.160 0.167 MONTANA ...... RURAL ...... 0.486 0.450 MONTANA ...... URBAN ...... 0.350 0.368 NORTH CAROLINA ...... RURAL ...... 0.206 0.216 NORTH CAROLINA ...... URBAN ...... 0.212 0.223 NORTH DAKOTA ...... RURAL ...... 0.366 0.411 NORTH DAKOTA ...... URBAN ...... 0.369 0.334 NEBRASKA ...... RURAL ...... 0.313 0.294 NEBRASKA ...... URBAN ...... 0.233 0.238 NEW HAMPSHIRE ...... RURAL ...... 0.307 0.320 NEW HAMPSHIRE ...... URBAN ...... 0.255 0.279 NEW JERSEY ...... URBAN ...... 0.200 0.195 NEW MEXICO ...... RURAL ...... 0.224 0.225
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TABLE 9—CY 2018 STATEWIDE AVERAGE CCRS—Continued
Previous default CCR State Urban/rural CY 2018 (CY 2017 default CCR OPPS final rule)
NEW MEXICO ...... URBAN ...... 0.284 0.280 NEVADA ...... RURAL ...... 0.175 0.196 NEVADA ...... URBAN ...... 0.114 0.123 NEW YORK ...... RURAL ...... 0.299 0.309 NEW YORK ...... URBAN ...... 0.303 0.292 OHIO ...... RURAL ...... 0.280 0.292 OHIO ...... URBAN ...... 0.203 0.207 OKLAHOMA ...... RURAL ...... 0.215 0.231 OKLAHOMA ...... URBAN ...... 0.169 0.180 OREGON ...... RURAL ...... 0.290 0.280 OREGON ...... URBAN ...... 0.336 0.344 PENNSYLVANIA ...... RURAL ...... 0.267 0.274 PENNSYLVANIA ...... URBAN ...... 0.173 0.179 PUERTO RICO ...... URBAN ...... 0.577 0.527 RHODE ISLAND ...... URBAN ...... 0.276 0.291 SOUTH CAROLINA ...... RURAL ...... 0.170 0.185 SOUTH CAROLINA ...... URBAN ...... 0.191 0.190 SOUTH DAKOTA ...... RURAL ...... 0.391 0.383 SOUTH DAKOTA ...... URBAN ...... 0.242 0.229 TENNESSEE ...... RURAL ...... 0.173 0.181 TENNESSEE ...... URBAN ...... 0.174 0.180 TEXAS ...... RURAL ...... 0.205 0.214 TEXAS ...... URBAN ...... 0.168 0.177 UTAH ...... RURAL ...... 0.391 0.349 UTAH ...... URBAN ...... 0.304 0.315 VIRGINIA ...... RURAL ...... 0.177 0.191 VIRGINIA ...... URBAN ...... 0.215 0.226 VERMONT ...... RURAL ...... 0.393 0.426 VERMONT ...... URBAN ...... 0.378 0.340 WASHINGTON ...... RURAL ...... 0.256 0.271 WASHINGTON ...... URBAN ...... 0.323 0.294 WISCONSIN ...... RURAL ...... 0.348 0.354 WISCONSIN ...... URBAN ...... 0.308 0.290 WEST VIRGINIA ...... RURAL ...... 0.253 0.266 WEST VIRGINIA ...... URBAN ...... 0.297 0.285 WYOMING ...... RURAL ...... 0.407 0.429 WYOMING ...... URBAN ...... 0.327 0.311
E. Adjustment for Rural Sole hospitals in urban areas. Our analysis longer become newly classified as an Community Hospitals (SCHs) and showed a difference in costs for rural EACH. Essential Access Community Hospitals SCHs. Therefore, for the CY 2006 OPPS, This adjustment for rural SCHs is (EACHs) Under Section 1833(t)(13)(B) of we finalized a payment adjustment for budget neutral and applied before the Act for CY 2018 rural SCHs of 7.1 percent for all services calculating outlier payments and In the CY 2006 OPPS final rule with and procedures paid under the OPPS, copayments. We stated in the CY 2006 comment period (70 FR 68556), we excluding separately payable drugs and OPPS final rule with comment period finalized a payment increase for rural biologicals, brachytherapy sources, and (70 FR 68560) that we would not sole community hospitals (SCHs) of 7.1 devices paid under the pass-through reestablish the adjustment amount on an percent for all services and procedures payment policy, in accordance with annual basis, but we may review the paid under the OPPS, excluding drugs, section 1833(t)(13)(B) of the Act. adjustment in the future and, if biologicals, brachytherapy sources, and In the CY 2007 OPPS/ASC final rule appropriate, would revise the devices paid under the pass-through with comment period (71 FR 68010 and adjustment. We provided the same 7.1 payment policy in accordance with 68227), for purposes of receiving this percent adjustment to rural SCHs, section 1833(t)(13)(B) of the Act, as rural adjustment, we revised § 419.43(g) including EACHs, again in CYs 2008 added by section 411 of the Medicare of the regulations to clarify that through 2017. Further, in the CY 2009 Prescription Drug, Improvement, and essential access community hospitals OPPS/ASC final rule with comment Modernization Act of 2003 (MMA) (Pub. (EACHs) also are eligible to receive the period (73 FR 68590), we updated the L. 108–173). Section 1833(t)(13) of the rural SCH adjustment, assuming these regulations at § 419.43(g)(4) to specify, Act provided the Secretary the authority entities otherwise meet the rural in general terms, that items paid at to make an adjustment to OPPS adjustment criteria. Currently, two charges adjusted to costs by application payments for rural hospitals, effective hospitals are classified as EACHs, and January 1, 2006, if justified by a study of a hospital-specific CCR are excluded of the difference in costs by APC as of CY 1998, under section 4201(c) of from the 7.1 percent payment between hospitals in rural areas and Public Law 105–33, a hospital can no adjustment.
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In the CY 2018 OPPS/ASC proposed amount under the OPPS than the (which we refer to as the ‘‘target PCR’’) rule (82 FR 33594 through 33595), for payment amount they would have for other hospitals paid under the OPPS. the CY 2018 OPPS, we proposed to received before implementation of the The target PCR is set in advance of the continue our policy of a 7.1 percent OPPS, as set forth in section calendar year and is calculated using payment adjustment that is done in a 1833(t)(7)(F) of the Act. The ‘‘pre-BBA the most recently submitted or settled budget neutral manner for rural SCHs, amount’’ is the product of the hospital’s cost report data that are available at the including EACHs, for all services and reasonable costs for covered outpatient time of final rulemaking for the calendar procedures paid under the OPPS, services occurring in the current year year. The amount of the payment excluding separately payable drugs and and the base payment-to-cost ratio (PCR) adjustment is made on an aggregate biologicals, devices paid under the pass- for the hospital defined in section basis at cost report settlement. We note through payment policy, and items paid 1833(t)(7)(F)(ii) of the Act. The ‘‘pre- that the changes made by section at charges reduced to costs. BBA amount’’ and the determination of 1833(t)(18) of the Act do not affect the Comment: Commenters supported the the base PCR are defined at 42 CFR existing statutory provisions that proposed payment adjustment for rural 419.70(f). TOPs are calculated on provide for TOPs for cancer hospitals. SCHs and EACHs, and stated that this Worksheet E, Part B, of the Hospital The TOPs are assessed as usual after all adjustment would support access to care Cost Report or the Hospital Health Care payments, including the cancer hospital in rural areas and provide additional Complex Cost Report (Form CMS–2552– payment adjustment, have been made resources for rural SCHs and EACHs. 96 or Form CMS–2552–10, respectively) for a cost reporting period. For CYs 2012 Response: We appreciate the as applicable each year. Section and 2013, the target PCR for purposes of commenters’ support. 1833(t)(7)(I) of the Act exempts TOPs the cancer hospital payment adjustment After consideration of the public from budget neutrality calculations. was 0.91. For CY 2014, the target PCR comments we received, we are Section 3138 of the Affordable Care for purposes of the cancer hospital finalizing the proposal for CY 2017 to Act amended section 1833(t) of the Act payment adjustment was 0.89. For CY continue our policy of a 7.1 percent by adding a new paragraph (18), which 2015, the target PCR was 0.90. For CY payment adjustment that is done in a instructs the Secretary to conduct a 2016, the target PCR was 0.92, as budget neutral manner for rural SCHs, study to determine if, under the OPPS, discussed in the CY 2016 OPPS/ASC including EACHs, for all services and outpatient costs incurred by cancer final rule with comment period (80 FR procedures paid under the OPPS, hospitals described in section 70362 through 70363). For CY 2017, the excluding separately payable drugs and 1886(d)(1)(B)(v) of the Act with respect target PCR was 0.91, as discussed in the biologicals, devices paid under the pass- to APC groups exceed outpatient costs CY 2017 OPPS/ASC final rule with through payment policy, and items paid incurred by other hospitals furnishing comment period (81 FR 79603 through at charges reduced to costs. services under section 1833(t) of the 7960). Act, as determined appropriate by the F. Payment Adjustment for Certain Secretary. Section 1833(t)(18)(A) of the 2. Proposed and Finalized Policy for CY Cancer Hospitals for CY 2018 Act requires the Secretary to take into 2018 1. Background consideration the cost of drugs and Section 16002(b) of the 21st Century biologicals incurred by cancer hospitals Cures Act (Pub. L. 114–255) amended Since the inception of the OPPS, and other hospitals. Section section 1833(t)(18) of the Act by adding which was authorized by the Balanced 1833(t)(18)(B) of the Act provides that, subparagraph (C), which requires that in Budget Act of 1997 (BBA) (Pub. L. 105– if the Secretary determines that cancer applying 42 CFR 419.43(i), that is, the 33), Medicare has paid the 11 hospitals hospitals’ costs are higher than those of payment adjustment for certain cancer that meet the criteria for cancer other hospitals, the Secretary shall hospitals, for services furnished on or hospitals identified in section provide an appropriate adjustment after January 1, 2018, the target PCR 1886(d)(1)(B)(v) of the Act under the under section 1833(t)(2)(E) of the Act to adjustment be reduced by 1.0 OPPS for covered outpatient hospital reflect these higher costs. In 2011, after percentage point less than what would services. These cancer hospitals are conducting the study required by otherwise apply. Section 16002(b) also exempted from payment under the IPPS. section 1833(t)(18)(A) of the Act, we provides that, in addition to the With the Medicare, Medicaid and determined that outpatient costs percentage reduction, the Secretary may SCHIP Balanced Budget Refinement Act incurred by the 11 specified cancer consider making an additional of 1999 (Pub. L. 106–113), Congress hospitals were greater than the costs percentage point reduction to the target established section 1833(t)(7) of the Act, incurred by other OPPS hospitals. For a PCR that takes into account payment ‘‘Transitional Adjustment to Limit complete discussion regarding the rates for applicable items and services Decline in Payment,’’ to determine cancer hospital cost study, we refer described under section 1833(t)(21)(C) OPPS payments to cancer and children’s readers to the CY 2012 OPPS/ASC final of the Act for hospitals that are not hospitals based on their pre-BBA rule with comment period (76 FR 74200 cancer hospitals described under payment amount (often referred to as through 74201). section 1886(d)(1)(B)(v) of the Act. ‘‘held harmless’’). Based on these findings, we finalized Further, in making any budget As required under section a policy to provide a payment neutrality adjustment under section 1833(t)(7)(D)(ii) of the Act, a cancer adjustment to the 11 specified cancer 1833(t) of the Act, the Secretary shall hospital receives the full amount of the hospitals that reflects their higher not take into account the reduced difference between payments for outpatient costs as discussed in the CY expenditures that result from covered outpatient services under the 2012 OPPS/ASC final rule with application of section 1833(t)(18)(C) of OPPS and a ‘‘pre-BBA amount.’’ That is, comment period (76 FR 74202 through the Act. In the CY 2018 OPPS/ASC cancer hospitals are permanently held 74206). Specifically, we adopted a proposed rule (82 FR 33595), for CY harmless to their ‘‘pre-BBA amount,’’ policy to provide additional payments 2018, we proposed to provide additional and they receive transitional outpatient to the cancer hospitals so that each payments to the 11 specified cancer payments (TOPs) or hold harmless cancer hospital’s final PCR for services hospitals so that each cancer hospital’s payments to ensure that they do not provided in a given calendar year is final PCR is equal to the weighted receive a payment that is lower in equal to the weighted average PCR average PCR (or ‘‘target PCR’’) for the
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other OPPS hospitals using the most Using this smaller dataset of cost CY 2018 APC relative payment weights recent submitted or settled cost report report data, we estimated that, on (3,724 hospitals) because it is data that were available at the time of average, the OPPS payments to other appropriate to use the same set of the development of the proposed rule, hospitals furnishing services under the hospitals that we are using to calibrate reduced by 1.0 percentage point to OPPS were approximately 90 percent of the modeled CY 2018 OPPS. The cost comply with section 16002(b) of the reasonable cost (weighted average PCR report data for the hospitals in this 21st Century Cures Act. We did not of 0.90). Therefore, after applying the dataset were from cost report periods propose an additional reduction beyond 1.0 percentage point reduction as with fiscal year ends ranging from 2012 the 1.0 percentage point reduction required by section 16002(b) of the 21st to 2017. We then removed the cost required by section 16002(b) for CY Century Cures Act, we proposed that the report data of the 49 hospitals located in 2018. To calculate the proposed CY payment amount associated with the Puerto Rico from our dataset because we 2018 target PCR, we used the same cancer hospital payment adjustment to do not believe that their cost structure extract of cost report data from HCRIS, be determined at cost report settlement reflects the costs of most hospitals paid as discussed in section II.A. of the would be the additional payment under the OPPS and, therefore, their proposed rule, used to estimate costs for needed to result in a proposed target inclusion may bias the calculation of PCR equal to 0.89 for each cancer the CY 2018 OPPS. Using these cost hospital-weighted statistics. We also hospital. report data, we included data from removed the cost report data of 14 Table 11 of the proposed rule hospitals because these hospitals had Worksheet E, Part B, for each hospital, indicated the proposed estimated using data from each hospital’s most cost report data that were not complete percentage increase in OPPS payments (missing aggregate OPPS payments, recent cost report, whether as submitted to each cancer hospital for CY 2018 due or settled. missing aggregate cost data, or missing to the cancer hospital payment both), so that all cost reports in the We then limited the dataset to the adjustment policy. We stated in the study would have both the payment and hospitals with CY 2016 claims data that proposed rule that the actual amount of cost data necessary to calculate a PCR we used to model the impact of the the CY 2018 cancer hospital payment for each hospital, leading to an analytic proposed CY 2018 APC relative adjustment for each cancer hospital will file of 3,661 hospitals with cost report payment weights (3,701 hospitals) be determined at cost report settlement data. and will depend on each hospital’s CY because it is appropriate to use the same Using this smaller dataset of cost set of hospitals that we are using to 2018 payments and costs. We noted that the requirements contained in section report data, we estimated a target PCR calibrate the modeled CY 2018 OPPS. of 0.89. Therefore, after applying the 1.0 The cost report data for the hospitals in 1833(t)(18) of the Act do not affect the existing statutory provisions that percentage point reduction as required this dataset were from cost report by section 16002(b) of the 21st Century periods with fiscal year ends ranging provide for TOPs for cancer hospitals. The TOPs will be assessed as usual after Cures Act, we are finalizing that the from 2013 to 2016. We then removed payment amount associated with the the cost report data of the 49 hospitals all payments, including the cancer hospital payment adjustment, have been cancer hospital payment adjustment to located in Puerto Rico from our dataset be determined at cost report settlement because we do not believe that their cost made for a cost reporting period. Comment: Several commenters will be the additional payment needed structure reflects the costs of most supported the proposed cancer hospital to result in a PCR equal to 0.88 for each hospitals paid under the OPPS and, payment adjustment for CY 2018. cancer hospital. Table 10 below therefore, their inclusion may bias the Response: We appreciate the indicates the estimated percentage calculation of hospital-weighted commenters’ support. increase in OPPS payments to each statistics. We also removed the cost After consideration of the public cancer hospital for CY 2018 due to the report data of 16 hospitals because these comments we received, we are cancer hospital payment adjustment hospitals had cost report data that were finalizing our cancer hospital payment policy. We note that the requirements not complete (missing aggregate OPPS adjustment methodology as proposed. contained in section 1833(t)(18) of the payments, missing aggregate cost data, For this final rule with comment period, Act do not affect the existing statutory or missing both), so that all cost reports we are using the most recent cost report provisions that provide for TOPs for in the study would have both the data through June 30, 2017 to update the cancer hospitals. The TOPs will be payment and cost data necessary to adjustment. This update yields a target assessed as usual after all payments, calculate a PCR for each hospital, PCR of 0.88. We limited the dataset to including the cancer hospital payment leading to a proposed analytic file of the hospitals with CY 2016 claims data adjustment, have been made for a cost 3,636 hospitals with cost report data. that we used to model the impact of the reporting period.
TABLE 10—ESTIMATED CY 2018 HOSPITAL-SPECIFIC PAYMENT ADJUSTMENT FOR CANCER HOSPITALS TO BE PROVIDED AT COST REPORT SETTLEMENT
Estimated percentage increase in OPPS Provider No. Hospital name payments for CY 2018 due to payment adjustment
050146 ...... City of Hope Comprehensive Cancer Center ...... 31.5 050660 ...... USC Norris Cancer Hospital ...... 16.4 100079 ...... Sylvester Comprehensive Cancer Center ...... 22.9 100271 ...... H. Lee Moffitt Cancer Center & Research Institute ...... 21.7
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TABLE 10—ESTIMATED CY 2018 HOSPITAL-SPECIFIC PAYMENT ADJUSTMENT FOR CANCER HOSPITALS TO BE PROVIDED AT COST REPORT SETTLEMENT—Continued
Estimated percentage increase in OPPS Provider No. Hospital name payments for CY 2018 due to payment adjustment
220162 ...... Dana-Farber Cancer Institute ...... 44.2 330154 ...... Memorial Sloan-Kettering Cancer Center ...... 46.9 330354 ...... Roswell Park Cancer Institute ...... 20.0 360242 ...... James Cancer Hospital & Solove Research Institute ...... 27.5 390196 ...... Fox Chase Cancer Center ...... 7.6 450076 ...... M.D. Anderson Cancer Center ...... 74.9 500138 ...... Seattle Cancer Care Alliance ...... 52.2
G. Hospital Outpatient Outlier percent of total spending in the claims discussed in section VIII.C. of the Payments being used to model the OPPS. Our proposed rule, we proposed to continue estimate of total outlier payments as a our longstanding policy that if a 1. Background percent of total CY 2016 OPPS CMHC’s cost for partial hospitalization The OPPS provides outlier payments payments, using CY 2016 claims services, paid under APC 5853 (Partial to hospitals to help mitigate the available for this proposed rule, is Hospitalization for CMHCs), exceeds financial risk associated with high-cost approximately 1.0 percent of the total 3.40 times the payment rate for and complex procedures, where a very aggregated OPPS payments. Therefore, proposed APC 5853, the outlier costly service could present a hospital for CY 2016, we estimate that we paid payment would be calculated as 50 with significant financial loss. As the outlier target of 1.0 percent of total percent of the amount by which the cost explained in the CY 2015 OPPS/ASC aggregated OPPS payments. exceeds 3.40 times the proposed APC final rule with comment period (79 FR As stated in the proposed rule, using 5853 payment rate. For further 66832 through 66834), we set our CY 2016 claims data and CY 2017 discussion of CMHC outlier payments, projected target for aggregate outlier payment rates, we estimated that the we refer readers to section VIII.D. of the payments at 1.0 percent of the estimated aggregate outlier payments for CY 2017 proposed rule. aggregate total payments under the would be approximately 1.0 percent of To ensure that the estimated CY 2018 OPPS for the prospective year. Outlier the total CY 2017 OPPS payments. aggregate outlier payments would equal payments are provided on a service-by- Using an updated claims dataset and 1.0 percent of estimated aggregate total service basis when the cost of a service OPPS ancillary CCRs, we estimate that payments under the OPPS, we proposed exceeds the APC payment amount we paid approximately 1.11 percent of that the hospital outlier threshold be set multiplier threshold (the APC payment the total CY 2017 OPPS payments, in so that outlier payments would be amount multiplied by a certain amount) OPPS outliers. We provided estimated triggered when a hospital’s cost of as well as the APC payment amount CY 2018 outlier payments for hospitals furnishing a service exceeds 1.75 times plus a fixed-dollar amount threshold and CMHCs with claims included in the the APC payment amount and exceeds (the APC payment plus a certain amount claims data that we used to model the APC payment amount plus $4,325. of dollars). In CY 2017, the outlier impacts in the Hospital-Specific We calculated the proposed fixed- threshold was met when the hospital’s Impacts—Provider-Specific Data file on dollar threshold of $4,325 using the cost of furnishing a service exceeded the CMS Web site at: https:// standard methodology most recently 1.75 times (the multiplier threshold) the www.cms.gov/Medicare/Medicare-Fee- used for CY 2017 (81 FR 79604 through APC payment amount and exceeded the for-Service-Payment/ APC payment amount plus $3,825 (the HospitalOutpatientPPS/index.html. 79605). For purposes of estimating fixed-dollar amount threshold) (81 FR outlier payments for the proposed rule, 79604 through 79606). If the cost of a 2. Outlier Calculation for CY 2018 we used the hospital-specific overall service exceeds both the multiplier In the CY 2018 OPPS/ASC proposed ancillary CCRs available in the April threshold and the fixed-dollar rule (82 FR 33596), for CY 2018, we 2017 update to the Outpatient Provider- threshold, the outlier payment is proposed to continue our policy of Specific File (OPSF). The OPSF calculated as 50 percent of the amount estimating outlier payments to be 1.0 contains provider-specific data, such as by which the cost of furnishing the percent of the estimated aggregate total the most current CCRs, which are service exceeds 1.75 times the APC payments under the OPPS. We proposed maintained by the MACs and used by payment amount. Beginning with CY that a portion of that 1.0 percent, an the OPPS Pricer to pay claims. The 2009 payments, outlier payments are amount equal to less than 0.01 percent claims that we use to model each OPPS subject to a reconciliation process of outlier payments (or 0.0001 percent update lag by 2 years. similar to the IPPS outlier reconciliation of total OPPS payments) would be In order to estimate the CY 2018 process for cost reports, as discussed in allocated to CMHCs for PHP outlier hospital outlier payments for the the CY 2009 OPPS/ASC final rule with payments. This is the amount of proposed rule, we inflated the charges comment period (73 FR 68594 through estimated outlier payments that would on the CY 2016 claims using the same 68599). result from the proposed CMHC outlier inflation factor of 1.104055 that we used It has been our policy to report the threshold as a proportion of total to estimate the IPPS fixed-dollar outlier actual amount of outlier payments as a estimated OPPS outlier payments. As threshold for the FY 2018 IPPS/LTCH
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PPS proposed rule (82 FR 20173). We CMHCs, we proposed that, if a CMHC’s outlier payments using these costs for used an inflation factor of 1.05074 to cost for partial hospitalization services, several different fixed-dollar thresholds, estimate CY 2017 charges from the CY paid under APC 5853, exceeds 3.40 holding the 1.75 multiple threshold 2016 charges reported on CY 2016 times the payment rate for APC 5853, constant and assuming that outlier claims. The methodology for the outlier payment would be calculated payments will continue to be made at 50 determining this charge inflation factor as 50 percent of the amount by which percent of the amount by which the cost is discussed in the FY 2017 IPPS/LTCH the cost exceeds 3.40 times the APC of furnishing the service would exceed PPS final rule (81 FR 57286). As we 5853 payment rate. 1.75 times the APC payment amount, stated in the CY 2005 OPPS final rule Section 1833(t)(17)(A) of the Act, until the total outlier payment equaled with comment period (69 FR 65845), we which applies to hospitals as defined 1.0 percent of aggregated estimated total believe that the use of these charge under section 1886(d)(1)(B) of the Act, CY 2018 OPPS payments. We estimate inflation factors are appropriate for the requires that hospitals that fail to report that a fixed-dollar threshold of $4,150, OPPS because, with the exception of the data required for the quality measures combined with the multiple threshold inpatient routine service cost centers, selected by the Secretary, in the form of 1.75 times the APC payment rate, will hospitals use the same ancillary and and manner required by the Secretary allocate 1.0 percent of aggregated total outpatient cost centers to capture costs under section 1833(t)(17)(B) of the Act, OPPS payments to outlier payments. We and charges for inpatient and outpatient incur a 2.0 percentage point reduction note that the difference in our services. to their OPD fee schedule increase calculation of the final fixed-dollar As noted in the CY 2007 OPPS/ASC factor; that is, the annual payment threshold of $4,150 and the proposed final rule with comment period (71 FR update factor. The application of a fixed-dollar threshold of $4,350 is 68011), we are concerned that we could reduced OPD fee schedule increase largely attributed to finalized proposals systematically overestimate the OPPS factor results in reduced national related to reducing payments for drugs hospital outlier threshold if we did not unadjusted payment rates that will purchased under the 340B drug program apply a CCR inflation adjustment factor. apply to certain outpatient items and for CY 2018, as discussed in section Therefore, we proposed to apply the services furnished by hospitals that are V.B.7. of this final rule with comment same CCR inflation adjustment factor required to report outpatient quality period. that we proposed to apply for the FY data and that fail to meet the Hospital For CMHCs, if a CMHC’s cost for 2018 IPPS outlier calculation to the OQR Program requirements. For partial hospitalization services, paid CCRs used to simulate the proposed CY hospitals that fail to meet the Hospital under APC 5853, exceeds 3.40 times the 2018 OPPS outlier payments to OQR Program requirements, we payment rate, the outlier payment will determine the fixed-dollar threshold. proposed to continue the policy that we be calculated as 50 percent of the Specifically, for CY 2018, we proposed implemented in CY 2010 that the amount by which the cost exceeds 3.40 to apply an adjustment factor of hospitals’ costs will be compared to the times APC 5853. 0.979187 to the CCRs that were in the reduced payments for purposes of April 2017 OPSF to trend them forward outlier eligibility and payment H. Calculation of an Adjusted Medicare from CY 2017 to CY 2018. The calculation. For more information on Payment From the National Unadjusted methodology for calculating this the Hospital OQR Program, we referred Medicare Payment proposed adjustment was discussed in readers to section XIII. of the proposed the FY 2018 IPPS/LTCH PPS proposed rule. The basic methodology for rule (82 FR 20173). We did not receive any public determining prospective payment rates To model hospital outlier payments comments on our hospital outpatient for HOPD services under the OPPS is set for the proposed rule, we applied the outlier payment methodology. forth in existing regulations at 42 CFR overall CCRs from the April 2017 OPSF Therefore, we are finalizing our part 419, subparts C and D. For this CY after adjustment (using the proposed proposal to continue our policy of 2018 OPPS/ASC final rule with CCR inflation adjustment factor of estimating outlier payments to be 1.0 comment period, the payment rate for 0.979187 to approximate CY 2018 CCRs) percent of the estimated aggregate total most services and procedures for which to charges on CY 2016 claims that were payments under the OPPS and to use payment is made under the OPPS is the adjusted (using the proposed charge our established methodology to set the product of the conversion factor inflation factor of 1.104055 to OPPS outlier fixed-dollar loss threshold calculated in accordance with section approximate CY 2018 charges). We for CY 2018. II.B. of this final rule with comment simulated aggregated CY 2018 hospital period and the relative payment weight 3. Final Outlier Calculation outlier payments using these costs for determined under section II.A. of this several different fixed-dollar thresholds, Consistent with historical practice, we final rule with comment period. holding the 1.75 multiplier threshold used updated data for this final rule Therefore, the national unadjusted constant and assuming that outlier with comment period for outlier payment rate for most APCs contained payments would continue to be made at calculations. For CY 2018, we are in Addendum A to this final rule with 50 percent of the amount by which the applying the overall CCRs from the July comment period (which is available via cost of furnishing the service would 2017 OPSF file after adjustment (using the Internet on the CMS Web site) and exceed 1.75 times the APC payment the CCR inflation adjustment factor of for most HCPCS codes to which separate amount, until the total outlier payments 0.9856 to approximate CY 2018 CCRs) to payment under the OPPS has been equaled 1.0 percent of aggregated charges on CY 2016 claims that were assigned in Addendum B to this final estimated total CY 2018 OPPS adjusted using a charge inflation factor rule with comment period (which is payments. We estimated that a proposed of 1.0936 to approximate CY 2018 available via the Internet on the CMS fixed-dollar threshold of $4,325, charges. These are the same CCR Web site) was calculated by multiplying combined with the proposed multiplier adjustment and charge inflation factors the CY 2018 scaled weight for the APC threshold of 1.75 times the APC that were used to set the IPPS fixed- by the CY 2018 conversion factor. We payment rate, would allocate 1.0 dollar thresholds for the FY 2018 IPPS/ note that this is the same methodology percent of aggregated total OPPS LTCH PPS final rule (82 FR 38527). We proposed in the CY 2018 OPPS/ASC payments to outlier payments. For simulated aggregated CY 2018 hospital proposed rule (82 FR 33598), on which
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we did not receive any public hospitals that meet the requirements of reclassifications under section comments. the Hospital OQR Program as the ‘‘full’’ 1886(d)(8)(E) of the Act, as defined in We note that section 1833(t)(17) of the national unadjusted payment rate. We § 412.103 of the regulations, and Act, which applies to hospitals as refer to the national unadjusted hospitals designated as urban under defined under section 1886(d)(1)(B) of payment rate for hospitals that fail to section 601(g) of Public Law 98–21. For the Act, requires that hospitals that fail meet the requirements of the Hospital further discussion of the changes to the to submit data required to be submitted OQR Program as the ‘‘reduced’’ national FY 2018 IPPS wage indexes, as applied on quality measures selected by the unadjusted payment rate. The reduced to the CY 2018 OPPS, we refer readers Secretary, in the form and manner and national unadjusted payment rate is to section II.C. of this final rule with at a time specified by the Secretary, calculated by multiplying the reporting comment period. We are continuing to incur a reduction of 2.0 percentage ratio of 0.980 times the ‘‘full’’ national apply a wage index floor of 1.00 to points to their OPD fee schedule unadjusted payment rate. The national frontier States, in accordance with increase factor, that is, the annual unadjusted payment rate used in the section 10324 of the Affordable Care Act payment update factor. The application calculations below is either the full of 2010. of a reduced OPD fee schedule increase national unadjusted payment rate or the Step 3. Adjust the wage index of factor results in reduced national reduced national unadjusted payment hospitals located in certain qualifying unadjusted payment rates that apply to rate, depending on whether the hospital counties that have a relatively high certain outpatient items and services met its Hospital OQR Program percentage of hospital employees who provided by hospitals that are required requirements in order to receive the full reside in the county, but who work in to report outpatient quality data and CY 2018 OPPS fee schedule increase a different county with a higher wage that fail to meet the Hospital OQR factor. index, in accordance with section 505 of Program (formerly referred to as the Step 1. Calculate 60 percent (the Public Law 108–173. Addendum L to Hospital Outpatient Quality Data labor-related portion) of the national this final rule with comment period Reporting Program (HOP QDRP)) unadjusted payment rate. Since the (which is available via the Internet on requirements. For further discussion of initial implementation of the OPPS, we the CMS Web site) contains the the payment reduction for hospitals that have used 60 percent to represent our qualifying counties and the associated fail to meet the requirements of the estimate of that portion of costs wage index increase developed for the Hospital OQR Program, we refer readers attributable, on average, to labor. We FY 2018 IPPS, which are listed in Table to section XIII. of this final rule with refer readers to the April 7, 2000 OPPS 2 in the FY 2018 IPPS/LTCH PPS final comment period. final rule with comment period (65 FR rule available via the Internet on the We demonstrate below the steps on 18496 through 18497) for a detailed CMS Web site at: http://www.cms.gov/ how to determine the APC payments discussion of how we derived this that will be made in a calendar year Medicare/Medicare-Fee-for-Service- percentage. During our regression Payment/AcuteInpatientPPS/ under the OPPS to a hospital that fulfills analysis for the payment adjustment for the Hospital OQR Program requirements index.html. (Click on the link on the left rural hospitals in the CY 2006 OPPS side of the screen titled ‘‘FY 2018 IPPS and to a hospital that fails to meet the final rule with comment period (70 FR Hospital OQR Program requirements for Final Rule Home Page’’ and select ‘‘FY 68553), we confirmed that this labor- a service that has any of the following 2018 Final Rule Tables.’’) This step is to related share for hospital outpatient status indicator assignments: ‘‘J1’’, ‘‘J2’’, be followed only if the hospital is not services is appropriate. reclassified or redesignated under ‘‘P’’, ‘‘Q1’’, ‘‘Q2’’, ‘‘Q3’’, ‘‘Q4’’, ‘‘R’’, ‘‘S’’, The formula below is a mathematical ‘‘T’’, ‘‘U’’, or ‘‘V’’ (as defined in section 1886(d)(8) or section 1886(d)(10) representation of Step 1 and identifies Addendum D1 to this final rule with of the Act. the labor-related portion of a specific comment period, which is available via Step 4. Multiply the applicable wage payment rate for a specific service. the Internet on the CMS Web site), in a index determined under Steps 2 and 3 circumstance in which the multiple X is the labor-related portion of the by the amount determined under Step 1 procedure discount does not apply, the national unadjusted payment rate. that represents the labor-related portion procedure is not bilateral, and X = .60 * (national unadjusted payment of the national unadjusted payment rate. conditionally packaged services (status rate). The formula below is a mathematical indicator of ‘‘Q1’’ and ‘‘Q2’’) qualify for Step 2. Determine the wage index area representation of Step 4 and adjusts the separate payment. We note that, in which the hospital is located and labor-related portion of the national although blood and blood products with identify the wage index level that unadjusted payment rate for the specific status indicator ‘‘R’’ and brachytherapy applies to the specific hospital. We note service by the wage index. sources with status indicator ‘‘U’’ are that, under the CY 2018 OPPS policy for Xa is the labor-related portion of the continuing to use the OMB labor market not subject to wage adjustment, they are national unadjusted payment rate area delineations based on the 2010 subject to reduced payments when a (wage adjusted). hospital fails to meet the Hospital OQR Decennial Census data for the wage Xa = .60 * (national unadjusted payment Program requirements. indexes used under the IPPS, a hold Individual providers interested in harmless policy for the wage index may rate) * applicable wage index. calculating the payment amount that apply, as discussed in section II.C. of Step 5. Calculate 40 percent (the they will receive for a specific service this final rule with comment period. nonlabor-related portion) of the national from the national unadjusted payment The wage index values assigned to each unadjusted payment rate and add that rates presented in Addenda A and B to area reflect the geographic statistical amount to the resulting product of Step this final rule with comment period areas (which are based upon OMB 4. The result is the wage index adjusted (which are available via the Internet on standards) to which hospitals are payment rate for the relevant wage the CMS Web site) should follow the assigned for FY 2018 under the IPPS, index area. formulas presented in the following reclassifications through the The formula below is a mathematical steps. For purposes of the payment Metropolitan Geographic Classification representation of Step 5 and calculates calculations below, we refer to the Review Board (MGCRB), section the remaining portion of the national national unadjusted payment rate for 1886(d)(8)(B) ‘‘Lugar’’ hospitals, payment rate, the amount not
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attributable to labor, and the adjusted reduced national adjusted payment is proposed to use the same standard payment for the specific service. approximately $658.22 ($433.68 + rounding principles that we have Y is the nonlabor-related portion of the $224.54). historically used in instances where the application of our standard copayment national unadjusted payment rate. I. Beneficiary Copayments Y = .40 * (national unadjusted payment methodology would result in a rate). 1. Background copayment amount that is less than 20 Adjusted Medicare Payment = Y + Xa. Section 1833(t)(3)(B) of the Act percent and cannot be rounded, under Step 6. If a provider is an SCH, as set requires the Secretary to set rules for standard rounding principles, to 20 forth in the regulations at § 412.92, or an determining the unadjusted copayment percent. (We refer readers to the CY EACH, which is considered to be an amounts to be paid by beneficiaries for 2008 OPPS/ASC final rule with SCH under section 1886(d)(5)(D)(iii)(III) covered OPD services. Section comment period (72 FR 66687) in which of the Act, and located in a rural area, 1833(t)(8)(C)(ii) of the Act specifies that we discuss our rationale for applying as defined in § 412.64(b), or is treated as the Secretary must reduce the national these rounding principles.) The being located in a rural area under unadjusted copayment amount for a proposed national unadjusted § 412.103, multiply the wage index covered OPD service (or group of such copayment amounts for services payable adjusted payment rate by 1.071 to services) furnished in a year in a under the OPPS that would be effective calculate the total payment. manner so that the effective copayment January 1, 2018 were included in The formula below is a mathematical rate (determined on a national Addenda A and B to the proposed rule representation of Step 6 and applies the unadjusted basis) for that service in the (which are available via the Internet on rural adjustment for rural SCHs. year does not exceed a specified the CMS Web site). Adjusted Medicare Payment (SCH or percentage. As specified in section We did not receive any public EACH) = Adjusted Medicare 1833(t)(8)(C)(ii)(V) of the Act, the comments on the proposed copayment Payment * 1.071. effective copayment rate for a covered amounts for new and revised APCs We are providing examples below of OPD service paid under the OPPS in CY using the same methodology we the calculation of both the full and 2006, and in calendar years thereafter, implemented beginning in CY 2004 or reduced national unadjusted payment shall not exceed 40 percent of the APC the standard rounding principles we rates that will apply to certain payment rate. apply to our copayment amounts. outpatient items and services performed Section 1833(t)(3)(B)(ii) of the Act Therefore, we are finalizing our by hospitals that meet and that fail to provides that, for a covered OPD service proposed copayment policies, without meet the Hospital OQR Program (or group of such services) furnished in modification. requirements, using the steps outlined a year, the national unadjusted As discussed in section XIII.E. of this above. For purposes of this example, we copayment amount cannot be less than final rule with comment period, for CY used a provider that is located in 20 percent of the OPD fee schedule 2018, the Medicare beneficiary’s Brooklyn, New York that is assigned to amount. However, section minimum unadjusted copayment and CBSA 35614. This provider bills one 1833(t)(8)(C)(i) of the Act limits the national unadjusted copayment for a service that is assigned to APC 5071 amount of beneficiary copayment that service to which a reduced national (Level 1 Excision/Biopsy/Incision and may be collected for a procedure unadjusted payment rate applies will Drainage). The CY 2018 full national performed in a year to the amount of the equal the product of the reporting ratio unadjusted payment rate for APC 5071 inpatient hospital deductible for that and the national unadjusted copayment, is approximately $572.81. The reduced year. or the product of the reporting ratio and national unadjusted payment rate for Section 4104 of the Affordable Care the minimum unadjusted copayment, APC 5071 for a hospital that fails to Act eliminated the Medicare Part B respectively, for the service. meet the Hospital OQR Program coinsurance for preventive services We note that OPPS copayments may requirements is approximately $561.35. furnished on and after January 1, 2011, increase or decrease each year based on This reduced rate is calculated by that meet certain requirements, changes in the calculated APC payment multiplying the reporting ratio of 0.980 including flexible sigmoidoscopies and rates due to updated cost report and by the full unadjusted payment rate for screening colonoscopies, and waived claims data, and any changes to the APC 5071. the Part B deductible for screening OPPS cost modeling process. However, The FY 2018 wage index for a colonoscopies that become diagnostic as described in the CY 2004 OPPS final provider located in CBSA 35614 in New during the procedure. Our discussion of rule with comment period, the York is 1.2876. The labor-related the changes made by the Affordable development of the copayment portion of the full national unadjusted Care Act with regard to copayments for methodology generally moves payment is approximately $442.53 (.60 preventive services furnished on and beneficiary copayments closer to 20 * $572.81 * 1.2876). The labor-related after January 1, 2011, may be found in percent of OPPS APC payments (68 FR portion of the reduced national section XII.B. of the CY 2011 OPPS/ASC 63458 through 63459). unadjusted payment is approximately final rule with comment period (75 FR In the CY 2004 OPPS final rule with $433.68 (.60 * $561.35 * 1.2876). The 72013). comment period (68 FR 63459), we nonlabor-related portion of the full adopted a new methodology to calculate national unadjusted payment is 2. OPPS Copayment Policy unadjusted copayment amounts in approximately $229.12 (.40 * $572.81). In the CY 2018 OPPS/ASC proposed situations including reorganizing APCs, The nonlabor-related portion of the rule (82 FR 33599), for CY 2018, we and we finalized the following rules to reduced national unadjusted payment is proposed to determine copayment determine copayment amounts in CY approximately $224.54 (.40 * $561.35). amounts for new and revised APCs 2004 and subsequent years. The sum of the labor-related and using the same methodology that we • When an APC group consists solely nonlabor-related portions of the full implemented beginning in CY 2004. of HCPCS codes that were not paid national adjusted payment is (We refer readers to the November 7, under the OPPS the prior year because approximately $671.65 ($442.53 + 2003 OPPS final rule with comment they were packaged or excluded or are $229.12). The sum of the portions of the period (68 FR 63458).) In addition, we new codes, the unadjusted copayment
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amount would be 20 percent of the APC methodology would, in general, reduce Wage-adjusted copayment amount for payment rate. the beneficiary coinsurance rate and the APC (SCH or EACH) = • If a new APC that did not exist copayment amount for APCs for which (Adjusted Medicare Payment * during the prior year is created and the payment rate changes as the result 1.071) * B. consists of HCPCS codes previously of the reconfiguration of APCs and/or Step 4. For a hospital that failed to assigned to other APCs, the copayment recalibration of relative payment meet its Hospital OQR Program amount is calculated as the product of weights (68 FR 63459). requirements, multiply the copayment the APC payment rate and the lowest 3. Calculation of an Adjusted calculated in Step 3 by the reporting coinsurance percentage of the codes ratio of 0.980. comprising the new APC. Copayment Amount for an APC Group • The unadjusted copayments for If no codes are added to or removed As we stated in the CY 2018 OPPS/ services payable under the OPPS that from an APC and, after recalibration of ASC proposed rule (82 FR 33600), will be effective January 1, 2018, are its relative payment weight, the new individuals interested in calculating the shown in Addenda A and B to this final payment rate is equal to or greater than national copayment liability for a rule with comment period (which are the prior year’s rate, the copayment Medicare beneficiary for a given service available via the Internet on the CMS amount remains constant (unless the provided by a hospital that met or failed Web site). We note that the national resulting coinsurance percentage is less to meet its Hospital OQR Program unadjusted payment rates and than 20 percent). requirements should follow the copayment rates shown in Addenda A • If no codes are added to or removed formulas presented in the following and B to this final rule with comment from an APC and, after recalibration of steps. period reflect the CY 2018 OPD fee its relative payment weight, the new Step 1. Calculate the beneficiary schedule increase factor discussed in payment rate is less than the prior year’s payment percentage for the APC by section II.B. of this final rule with rate, the copayment amount is dividing the APC’s national unadjusted comment period. calculated as the product of the new copayment by its payment rate. For In addition, as noted earlier, section payment rate and the prior year’s example, using APC 5071, $114.57 is 1833(t)(8)(C)(i) of the Act limits the coinsurance percentage. • approximately 20 percent of the full amount of beneficiary copayment that If HCPCS codes are added to or national unadjusted payment rate of deleted from an APC and, after may be collected for a procedure $572.81. For APCs with only a performed in a year to the amount of the recalibrating its relative payment minimum unadjusted copayment in weight, holding its unadjusted inpatient hospital deductible for that Addenda A and B to this final rule with year. copayment amount constant results in a comment period rule (which are decrease in the coinsurance percentage available via the Internet on the CMS III. OPPS Ambulatory Payment for the reconfigured APC, the Web site), the beneficiary payment Classification (APC) Group Policies copayment amount would not change percentage is 20 percent. (unless retaining the copayment amount A. OPPS Treatment of New CPT and The formula below is a mathematical would result in a coinsurance rate less Level II HCPCS Codes representation of Step 1 and calculates than 20 percent). CPT and Level II HCPCS codes are the national copayment as a percentage • If HCPCS codes are added to an used to report procedures, services, of national payment for a given service. APC and, after recalibrating its relative items, and supplies under the hospital payment weight, holding its unadjusted B is the beneficiary payment percentage. OPPS. Specifically, CMS recognizes the copayment amount constant results in B = National unadjusted copayment for following codes on OPPS claims: an increase in the coinsurance APC/national unadjusted payment • Category I CPT codes, which percentage for the reconfigured APC, the rate for APC. describe surgical procedures and copayment amount would be calculated Step 2. Calculate the appropriate medical services; as the product of the payment rate of the wage-adjusted payment rate for the APC • Category III CPT codes, which reconfigured APC and the lowest for the provider in question, as describe new and emerging coinsurance percentage of the codes indicated in Steps 2 through 4 under technologies, services, and procedures; being added to the reconfigured APC. section II.H. of this final rule with and We noted in the CY 2004 OPPS final comment period. Calculate the rural • Level II HCPCS codes, which are rule with comment period that we adjustment for eligible providers as used primarily to identify products, would seek to lower the copayment indicated in Step 6 under section II.H. supplies, temporary procedures, and percentage for a service in an APC from of this final rule with comment period. services not described by CPT codes. the prior year if the copayment Step 3. Multiply the percentage CPT codes are established by the percentage was greater than 20 percent. calculated in Step 1 by the payment rate American Medical Association (AMA) We noted that this principle was calculated in Step 2. The result is the and the Level II HCPCS codes are consistent with section 1833(t)(8)(C)(ii) wage-adjusted copayment amount for established by the CMS HCPCS of the Act, which accelerates the the APC. Workgroup. These codes are updated reduction in the national unadjusted The formula below is a mathematical and changed throughout the year. CPT coinsurance rate so that beneficiary representation of Step 3 and applies the and HCPCS code changes that affect the liability will eventually equal 20 beneficiary payment percentage to the OPPS are published both through the percent of the OPPS payment rate for all adjusted payment rate for a service annual rulemaking cycle and through OPPS services to which a copayment calculated under section II.H. of this the OPPS quarterly update Change applies, and with section 1833(t)(3)(B) final rule with comment period, with Requests (CRs). CMS releases new Level of the Act, which achieves a 20-percent and without the rural adjustment, to II HCPCS codes to the public or copayment percentage when fully calculate the adjusted beneficiary recognizes the release of new CPT codes phased in and gives the Secretary the copayment for a given service. by the AMA and makes these codes authority to set rules for determining Wage-adjusted copayment amount for effective (that is, the codes can be copayment amounts for new services. the APC = Adjusted Medicare reported on Medicare claims) outside of We further noted that the use of this Payment * B. the formal rulemaking process via OPPS
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quarterly update CRs. Based on our comments on these new codes and status indicators do not. Section XI. of review, we assign the new CPT and finalize our proposals related to these this final rule with comment period Level II HCPCS codes to interim status codes through our annual rulemaking discusses the various status indicators indicators (SIs) and APCs. These interim process. used under the OPPS. assignments are finalized in the OPPS/ We note that, under the OPPS, the As we did in the CY 2018 OPPS/ASC ASC final rules. This quarterly process APC assignment determines the proposed rule, in Table 11 below, we offers hospitals access to codes that may payment rate for an item, procedure, or more accurately describe items or service. Those items, procedures, or summarize our current process for services furnished and provides services not paid separately under the updating codes through our OPPS payment or more accurate payment for hospital OPPS are assigned to quarterly update CRs, seeking public these items or services in a timelier appropriate status indicators. Certain comments, and finalizing the treatment manner than if we waited for the annual payment status indicators provide of these new codes under the OPPS. rulemaking process. We solicit public separate payment, while other payment
TABLE 11—COMMENT TIMEFRAME FOR NEW OR REVISED HCPCS CODES
OPPS quarterly update CR Type of code Effective date Comments sought When finalized
April 1, 2017 ...... Level II HCPCS Codes ..... April 1, 2017 ...... CY 2018 OPPS/ASC pro- CY 2018 OPPS/ASC final posed rule. rule with comment pe- riod. July 1, 2017 ...... Level II HCPCS Codes ..... July 1, 2017 ...... CY 2018 OPPS/ASC pro- CY 2018 OPPS/ASC final posed rule. rule with comment pe- riod. Category I (certain vaccine July 1, 2017 ...... CY 2018 OPPS/ASC pro- CY 2018 OPPS/ASC final codes) and III CPT posed rule. rule with comment pe- codes. riod. October 1, 2017 ...... Level II HCPCS Codes ..... October 1, 2017 ...... CY 2018 OPPS/ASC final CY 2019 OPPS/ASC final rule with comment pe- rule with comment pe- riod. riod. January 1, 2018 ...... Level II HCPCS Codes ..... January 1, 2018 ...... CY 2018 OPPS/ASC final CY 2019 OPPS/ASC final rule with comment pe- rule with comment pe- riod. riod. Category I and III CPT January 1, 2018 ...... CY 2018 OPPS/ASC pro- CY 2018 OPPS/ASC final Codes. posed rule. rule with comment pe- riod.
1. Treatment of New HCPCS Codes That under the OPPS. In the CY 2018 OPPS/ codes C9484, C9485, C9486, C9487, and Were Effective April 1, 2017 for Which ASC proposed rule (82 FR 33601), we C9488. We note that HCPCS code C9487 We Solicited Public Comments in the solicited public comments on the was deleted on June 30, 2017, and CY 2018 OPPS/ASC Proposed Rule proposed APC and status indicator replaced with HCPCS code Q9989, assignments for these Level II HCPCS effective July 1, 2017. We indicated that Through the April 2017 OPPS codes, which were displayed in Table the proposed payment rates for these quarterly update CR (Transmittal 3728, 13 of the proposed rule and are now codes were included in Addendum B to Change Request 10005, dated March 3, listed in Table 12 of this final rule with the proposed rule (which is available 2017), we made effective five new Level comment period. Specifically, we via the Internet on the CMS Web site). II HCPCS codes for separate payment solicited public comments on HCPCS
TABLE 12—NEW LEVEL II HCPCS CODES EFFECTIVE APRIL 1, 2017
CY 2017 CY 2018 Final Final HCPCS code HCPCS code CY 2018 long descriptor CY 2018 SI CY 2018 APC
C9484 ...... J1428 Injection, eteplirsen, 10 mg ...... G 9484 C9485 ...... J9285 Injection, olaratumab, 10 mg ...... G 9485 C9486 ...... J1627 Injection, granisetron, extended-release, 0.1 mg ...... G 9486 C9487 * ...... J3358 Ustekinumab, for intravenous injection, 1 mg ...... G 9487 C9488 ...... C9488 Injection, conivaptan hydrochloride, 1 mg ...... G 9488 * HCPCS code C9487, which was effective April 1, 2017, was deleted June 30, 2017 and replaced with HCPCS code Q9989 (Ustekinumab, for intravenous injection, 1 mg) effective July 1, 2017.
We did not receive any public that several of the HCPCS C-codes have the CMS Web site). In addition, the comments on the proposed APC and been replaced with HCPCS J-codes status indicator meanings can be found status indicator assignments for the new effective January 1, 2018. Their in Addendum A to this final rule with Level II HCPCS codes implemented in replacement codes are listed in Table 12 comment period (which is available via April 2017. Therefore, we are finalizing above. The final payment rates for these the Internet on the CMS Web site). the proposed APC and status indicator codes can be found in Addendum B to assignments for these codes, as this final rule with comment period indicated in Table 12 above. We note (which is available via the Internet on
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2. Treatment of New HCPCS Codes That replaced HCPCS code J1725 (Injection, codes, where applicable, were included Were Effective July 1, 2017 for Which hydroxyprogesterone caproate, 1 mg), in Addendum B to the proposed rule We Solicited Public Comments in the HCPCS codes Q9987 and Q9988 (which is available via the Internet on CY 2018 OPPS/ASC Proposed Rule replaced HCPCS code P9072 (Platelets, the CMS Web site). As discussed in the CY 2018 OPPS/ pheresis, pathogen reduced or rapid We did not receive any public ASC proposed rule (82 FR 33602), bacterial tested, each unit), and HCPCS comments on the proposed APC and through the July 2017 OPPS quarterly code Q9989 replaced HCPCS code status indicator assignments for the new update CR (Transmittal 3783, Change C9487 (Ustekinumab, for intravenous Category III CPT codes and Level II Request 10122, dated May 26, 2017), we injection, 1 mg). With the establishment HCPCS codes implemented in July made 10 new Category III CPT codes of HCPCS codes Q9986, Q9987, and 2017. Therefore, we are finalizing the and 13 Level II HCPCS codes effective Q9988, we made their predecessor proposed APC and status indicator July 1, 2017, and assigned them to HCPCS codes J1725 and P9072 inactive assignments for these codes, as appropriate interim OPPS status for reporting and revised the status indicated in Table 13 below. We note indicators and APCs. In the CY 2018 indicators for both codes to ‘‘E1’’ (Not that several of the HCPCS C and Q- OPPS/ASC proposed rule, we solicited Payable by Medicare) effective July 1, codes have been replaced with HCPCS public comments on the proposed APC 2017. In addition, because HCPCS code J-codes effective January 1, 2018. Their and status indicator assignments for CY Q9989 describes the same drug as replacement codes are listed in Table 13 2018 for the CPT and Level II HCPCS HCPCS code C9487, in the CY 2018 below. The final payment rates for these codes implemented on July 1, 2017, all OPPS/ASC proposed rule, we proposed codes can be found in Addendum B to of which were displayed in Table 14 of to continue the drug’s pass-through this final rule with comment period the proposed rule, and are now listed in payment status and to assign HCPCS (which is available via the Internet on Table 13 of this final rule with comment code Q9989 to the same APC and status the CMS Web site). In addition, the period. We note that three of the new indicator as its predecessor HCPCS code status indicator meanings can be found HCPCS codes effective July 1, 2017 C9487, as shown in Table 14 of the in Addendum A to this final rule with replaced four existing HCPCS codes. proposed rule. The proposed payment comment period (which is available via Specifically, HCPCS code Q9986 rates and status indicators for these the Internet on the CMS Web site).
TABLE 13—NEW CATEGORY III CPT AND LEVEL II HCPCS CODES EFFECTIVE JULY 1, 2017
CY 2017 CY 2018 Final Final HCPCS code HCPCS code CY 2018 long descriptor CY 2018 SI CY 2018 APC
C9489 ...... J2326 ...... Injection, nusinersen, 0.1 mg ...... G 9489 C9490 ...... J0565 ...... Injection, bezlotoxumab, 10 mg ...... G 9490 C9745 ...... C9745 ...... Nasal endoscopy, surgical; balloon dilation of eustachian tube ...... J1 5165 C9746 ...... C9746 ...... Transperineal implantation of permanent adjustable balloon continence de- J1 5377 vice, with cystourethroscopy, when performed and/or fluoroscopy, when performed. C9747 ...... C9747 ...... Ablation of prostate, transrectal, high intensity focused ultrasound (HIFU), J1 5376 including imaging guidance. K0553 ...... K0553 ...... Supply allowance for therapeutic continuous glucose monitor (CGM), in- Y N/A cludes all supplies and accessories, 1 month supply = 1 Unit Of Service. K0554 ...... K0554 ...... Receiver (monitor), dedicated, for use with therapeutic glucose continuous Y N/A monitor system. Q9984 ...... J7296 ...... Levonorgestrel-releasing intrauterine contraceptive system (Kyleena), 19.5 E1 N/A mg. Q9985 ...... J1729 ...... Injection, hydroxyprogesterone caproate, not otherwise specified, 10 mg .... N N/A Q9986 ...... J1726 ...... Injection, hydroxyprogesterone caproate (Makena), 10 mg ...... K 9074 Q9987 ...... P9100 ...... Pathogen(s) test for platelets ...... S 1493 Q9988 ...... P9073 ...... Platelets, pheresis, pathogen reduced, each unit ...... R 9536 Q9989 ...... J3358 ...... Ustekinumab, for intravenous injection, 1 mg ...... G 9487 0469T ...... 0469T ...... Retinal polarization scan, ocular screening with on-site automated results, E1 N/A bilateral. 0470T ...... 0470T ...... Optical coherence tomography (OCT) for microstructural and morphological M N/A imaging of skin, image acquisition, interpretation, and report; first lesion. 0471T ...... 0471T ...... Optical coherence tomography (OCT) for microstructural and morphological N N/A imaging of skin, image acquisition, interpretation, and report; each addi- tional lesion (List separately in addition to code for primary procedure). 0472T ...... 0472T ...... Device evaluation, interrogation, and initial programming of intra- ocular Q1 5743 retinal electrode array (eg, retinal prosthesis), in person, with iterative adjustment of the implantable device to test functionality, select optimal permanent programmed values with analysis, including visual training, with review and report by a qualified health care professional. 0473T ...... 0473T ...... Device evaluation and interrogation of intra-ocular retinal electrode array Q1 5742 (eg, retinal prosthesis), in person, including reprogramming and visual training, when performed, with review and report by a qualified health care professional. 0474T ...... 0474T ...... Insertion of anterior segment aqueous drainage device, with creation of J1 5492 intraocular reservoir, internal approach, into the supraciliary space. 0475T ...... 0475T ...... Recording of fetal magnetic cardiac signal using at least 3 channels; pa- M N/A tient recording and storage, data scanning with signal extraction, tech- nical analysis and result, as well as supervision, review, and interpreta- tion of report by a physician or other qualified health care professional.
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TABLE 13—NEW CATEGORY III CPT AND LEVEL II HCPCS CODES EFFECTIVE JULY 1, 2017—Continued
CY 2017 CY 2018 Final Final HCPCS code HCPCS code CY 2018 long descriptor CY 2018 SI CY 2018 APC
0476T ...... 0476T ...... Recording of fetal magnetic cardiac signal using at least 3 channels; pa- Q1 5734 tient recording, data scanning, with raw electronic signal transfer of data and storage. 0477T ...... 0477T ...... Recording of fetal magnetic cardiac signal using at least 3 channels; signal Q1 5734 extraction, technical analysis, and result. 0478T ...... 0478T ...... Recording of fetal magnetic cardiac signal using at least 3 channels; re- M N/A view, interpretation, report by physician or other qualified health care professional.
3. Process for New Level II HCPCS indicate that we have assigned these to avoid the resort to HCPCS G-codes Codes That Became Effective October 1, codes an interim OPPS payment status and the resulting delay in utilization of 2017 and New Level II HCPCS Codes for CY 2018. We are inviting public the most current CPT codes. Also, we That Will Be Effective January 1, 2018 comments on the interim status finalized our proposal to make interim for Which We Are Soliciting Public indicator and APC assignments for these APC and status indicator assignments Comments in This CY 2018 OPPS/ASC codes, if applicable, that will be for CPT codes that are not available in Final Rule With Comment Period finalized in the CY 2019 OPPS/ASC time for the proposed rule and that As has been our practice in the past, final rule with comment period. describe wholly new services (such as new technologies or new surgical we incorporate those new Level II 4. Treatment of New and Revised procedures), solicit public comments, HCPCS codes that are effective October Category I and III CPT Codes That Will and finalize the specific APC and status 1 and January 1 in the final rule with Be Effective January 1, 2018 for Which indicator assignments for those codes in comment period, thereby updating the We Solicited Public Comments in the the following year’s final rule. OPPS for the following calendar year, as CY 2018 OPPS/ASC Proposed Rule displayed in Table 11 of this final rule For the CY 2018 OPPS update, we with comment period. These codes are In the CY 2015 OPPS/ASC final rule received the CY 2018 CPT codes from released to the public through the with comment period (79 FR 66841 AMA in time for inclusion in the CY October and January OPPS quarterly through 66844), we finalized a revised 2018 OPPS/ASC proposed rule. The update CRs and via the CMS HCPCS process of assigning APC and status new, revised, and deleted CY 2018 Web site (for Level II HCPCS codes). For indicators for new and revised Category Category I and III CPT codes were CY 2018, these codes are flagged with I and III CPT codes that would be included in Addendum B to the CY comment indicator ‘‘NI’’ in Addendum effective January 1. Specifically, for the 2018 OPPS/ASC proposed rule (which B to this OPPS/ASC final rule with new/revised CPT codes that we receive is available via the Internet on the CMS comment period to indicate that we are in a timely manner from the AMA’s CPT Web site). We noted in the proposed assigning them an interim payment Editorial Panel, we finalized our rule that the new and revised codes are status which is subject to public proposal to include the codes that assigned to new comment indicator comment. Specifically, the status would be effective January 1 in the ‘‘NP’’ to indicate that the code is new indicators and the APC assignments for OPPS/ASC proposed rules, along with for the next calendar year or the code is codes flagged with comment indicator proposed APC and status indicator an existing code with substantial ‘‘NI’’ are open to public comment in this assignments for them, and to finalize the revision to its code descriptor in the final rule with comment period, and we APC and status indicator assignments in next calendar year as compared to the will respond to these public comments the OPPS/ASC final rules beginning current calendar year with a proposed in the OPPS/ASC final rule with with the CY 2016 OPPS update. For APC assignment, and that comments comment period for the next year’s those new/revised CPT codes that were will be accepted on the proposed APC OPPS/ASC update. In the CY 2018 received too late for inclusion in the assignment and status indicator. OPPS/ASC proposed rule (82 FR 33603), OPPS/ASC proposed rule, we finalized Further, in the CY 2018 OPPS/ASC we proposed to continue this process for our proposal to establish and use proposed rule, we reminded readers that CY 2018. Specifically, for CY 2018, we HCPCS G-codes that mirror the the CPT code descriptors that appear in proposed to include in Addendum B to predecessor CPT codes and retain the Addendum B are short descriptors and the CY 2018 OPPS/ASC final rule with current APC and status indicator do not fully describe the complete comment period the following new assignments for a year until we can procedure, service, or item described by HCPCS codes: propose APC and status indicator the CPT code. Therefore, we included • New Level II HCPCS codes effective assignments in the following year’s the 5-digit placeholder codes and their October 1, 2017, that would be rulemaking cycle. We note that even if long descriptors for the new and revised incorporated in the October 2017 OPPS we find that we need to create HCPCS CY 2018 CPT codes in Addendum O to quarterly update CR; and G-codes in place of certain CPT codes the proposed rule (which is available • New Level II HCPCS codes effective for the MPFS proposed rule, we do not via the Internet on the CMS Web site) January 1, 2018, that would be anticipate that these HCPCS G-codes so that the public could adequately incorporated in the January 2018 OPPS will always be necessary for OPPS comment on our proposed APCs and quarterly update CR. purposes. We will make every effort to status indicator assignments. We As stated above, the October 1, 2017 include proposed APC and status indicated that the 5-digit placeholder and January 1, 2018 codes are flagged indicator assignments for all new and codes were included in Addendum O, with comment indicator ‘‘NI’’ in revised CPT codes that the AMA makes specifically under the column labeled Addendum B to this CY 2018 OPPS/ publicly available in time for us to ‘‘CY 2018 OPPS/ASC Proposed Rule 5- ASC final rule with comment period to include them in the proposed rule, and Digit AMA Placeholder Code,’’ to the
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proposed rule. We stated that the final Section 1833(t)(2)(B) of the Act provides often than annually, and revise the APC CPT code numbers will be included in that the Secretary may establish groups groups, the relative payment weights, the CY 2018 OPPS/ASC final rule with of covered OPD services within this and the wage and other adjustments comment period. We noted that not classification system, so that services described in paragraph (2) to take into every code listed in Addendum O is classified within each group are account changes in medical practice, subject to comment. For the new and comparable clinically and with respect changes in technology, the addition of revised Category I and III CPT codes, we to the use of resources. In accordance new services, new cost data, and other requested comments on only those with these provisions, we developed a relevant information and factors. codes that are assigned to comment grouping classification system, referred Section 1833(t)(9)(A) of the Act also indicator ‘‘NP’’. We indicated that to as Ambulatory Payment requires the Secretary to consult with an public comments would not be accepted Classifications (APCs), as set forth in expert outside advisory panel composed for new Category I CPT laboratory codes § 419.31 of the regulations. We use of an appropriate selection of that were not assigned to the ‘‘NP’’ Level I and Level II HCPCS codes to representatives of providers to review comment indicator in Addendum O to identify and group the services within (and advise the Secretary concerning) the proposed rule. We stated that each APC. The APCs are organized such the clinical integrity of the APC groups comments to these codes must be that each group is homogeneous both and the relative payment weights. We submitted at the Clinical Laboratory Fee clinically and in terms of resource use. note that the HOP Panel Schedule (CLFS) Public Meeting, which Using this classification system, we recommendations for specific services was scheduled on July 31–August 1, have established distinct groups of for the CY 2018 OPPS and our responses 2017. similar services. We also have to them are discussed in the relevant In summary, we solicited public developed separate APC groups for specific sections throughout this final comments on the proposed APC and certain medical devices, drugs, rule with comment period. status indicator assignments for the new biologicals, therapeutic In addition, section 1833(t)(2) of the and revised Category I and III CPT codes radiopharmaceuticals, and Act provides that, subject to certain that will be effective January 1, 2018. brachytherapy devices that are not exceptions, the items and services The CPT codes were listed in packaged into the payment for the within an APC group cannot be Addendum B to the proposed rule with procedure. considered comparable with respect to short descriptors only. We listed them We have packaged into the payment the use of resources if the highest cost again in Addendum O to the proposed for each procedure or service within an for an item or service in the group is rule with long descriptors. We also APC group the costs associated with more than 2 times greater than the proposed to finalize the status indicator those items and services that are lowest cost for an item or service within and APC assignments for these codes typically ancillary and supportive to a the same group (referred to as the ‘‘2 (with their final CPT code numbers) in primary diagnostic or therapeutic times rule’’). The statute authorizes the the CY 2018 OPPS/ASC final rule with modality and, in those cases, are an Secretary to make exceptions to the 2 comment period. integral part of the primary service they times rule in unusual cases, such as Commenters addressed several of the support. Therefore, we do not make low-volume items and services (but the new CPT codes that were assigned to separate payment for these packaged Secretary may not make such an comment indicator ‘‘NP’’ in Addendum items or services. In general, packaged exception in the case of a drug or B to the CY 2018 OPPS/ASC proposed items and services include, but are not biological that has been designated as an rule. We have responded to those public limited to, the items and services listed orphan drug under section 526 of the comments in sections II.A.2.b. in § 419.2(b) of the regulations. A Federal Food, Drug, and Cosmetic Act). Therefore, in accordance with section (Comprehensive APCs), III.D. (OPPS further discussion of packaged services 1833(t)(2) of the Act and § 419.31 of the APC-Specific Policies), V. (OPPS is included in section II.A.3. of this final regulations, we annually review the Payment Changes for Drugs, Biologicals, rule with comment period. Under the OPPS, we generally pay for items and services within an APC group and Radiopharmaceuticals), and XII. covered hospital outpatient services on to determine if there are any APC (Updates to the ASC Payment System) a rate-per-service basis, where the violations of the 2 times rule and of this CY 2018 OPPS/ASC final rule service may be reported with one or whether there are any appropriate with comment period. more HCPCS codes. Payment varies revisions to APC assignments that may The final status indicators, APC according to the APC group to which be necessary or exceptions to be made. assignments, and payment rates for the the independent service or combination In determining the APCs with a 2 times new CPT codes that are effective of services is assigned. In the CY 2018 rule violation, we consider only those January 1, 2018 can be found in OPPS/ASC proposed rule (82 FR 33604), HCPCS codes that are significant based Addendum B to this final rule with for CY 2018, we proposed that each APC on the number of claims. We note that, comment period (which is available via relative payment weight represents the for purposes of identifying significant the Internet on the CMS Web site). In hospital cost of the services included in procedure codes for examination under addition, the status indicator meanings that APC, relative to the hospital cost of the 2 times rule, we consider procedure can be found in Addendum A to this the services included in APC 5012 codes that have more than 1,000 single final rule with comment period (which (Clinic Visits and Related Services). The major claims or procedure codes that is available via the Internet on the CMS APC relative payment weights are have both greater than 99 single major Web site). scaled to APC 5012 because it is the claims and contribute at least 2 percent B. OPPS Changes—Variations Within hospital clinic visit APC and clinic of the single major claims used to APCs visits are among the most frequently establish the APC cost to be significant furnished services in the hospital (75 FR 71832). This longstanding 1. Background outpatient setting. definition of when a procedure code is Section 1833(t)(2)(A) of the Act significant for purposes of the 2 times requires the Secretary to develop a 2. Application of the 2 Times Rule rule was selected because we believe classification system for covered Section 1833(t)(9)(A) of the Act that a subset of 1,000 claims (or less hospital outpatient department services. requires the Secretary to review, not less than 1,000 claims) is negligible within
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the set of approximately 100 million HospitalOutpatientPPS/Addendum-A- before December 31, 2016. We indicated single procedure or single session and-Addendum-B-Updates.html). that, for the final rule with comment claims we use for establishing costs. Addendum B to this final rule with period, we intended to use claims data Similarly, a procedure code for which comment period (available via the for dates of service between January 1, there are fewer than 99 single claims Internet on the CMS Web site) identifies 2016, and December 31, 2016, that were and which comprises less than 2 with the ‘‘CH’’ comment indicator the processed on or before June 30, 2017, percent of the single major claims final CY 2018 changes compared to the and updated CCRs, if available. within an APC will have a negligible HCPCS codes’ status as reflected in the Based on the updated final rule CY impact on the APC cost. In the CY 2018 October 2017 Addendum B update. 2016 claims data used for this CY 2018 OPPS/ASC proposed rule (81 FR 33604 final rule with comment period, we 3. APC Exceptions to the 2 Times Rule through 33605), we proposed to make were able to remedy 6 APC violations exceptions to this limit on the variation Taking into account the APC changes out of the 12 APCs that appeared in of costs within each APC group in that we proposed for CY 2018, we Table 16 of the CY 2018 OPPS/ASC unusual cases, such as low-volume reviewed all of the APCs to determine proposed rule. Specifically, we found items and services. which APCs would not meet the that the following 6 APCs no longer met For the CY 2018 OPPS update, we requirements of the 2 times rule. We the criteria for exception to the 2 times identified the APCs with violations of used the following criteria to evaluate rule in this final rule with comment the 2 times rule, and we proposed whether to propose exceptions to the 2 period: • changes to the procedure codes assigned times rule for affected APCs: APC 5161 (Level 1 ENT • Resource homogeneity; to these APCs in Addendum B to the CY Procedures); • Clinical homogeneity; • APC 5311 (Level 1 Lower GI 2018 OPPS/ASC proposed rule. We • Hospital outpatient setting noted that Addendum B did not appear Procedures); utilization; • APC 5461 (Level 1 Neurostimulator in the printed version of the Federal • Frequency of service (volume); and Register as part of the CY 2018 OPPS/ • and Related Procedures); Opportunity for upcoding and code • APC 5573 (Level 3 Imaging with ASC proposed rule. Rather, it was fragments. published and made available via the Contrast); Based on the CY 2016 claims data • APC 5611 (Level 1 Therapeutic Internet on the CMS Web site at: http:// available for the CY 2018 proposed rule, Radiation Treatment Preparation); and www.cms.gov/Medicare/Medicare-Fee- we found 12 APCs with violations of the • APC 5735 (Level 5 Minor for-Service-Payment/ 2 times rule. We applied the criteria as Procedures). HospitalOutpatientPPS/index.html. In described above to identify the APCs for Secondly, based on our analysis of the these cases, to eliminate a violation of which we proposed to make exceptions final rule claims data, we found a total the 2 times rule or to improve clinical under the 2 times rule for CY 2018, and of 11 APCs with violations of the 2 and resource homogeneity, in the CY found that all of the 12 APCs we times rule. Of these 11 total APCs, 6 2018 OPPS/ASC proposed rule (81 FR identified met the criteria for an were identified in the proposed rule and 33604 through 33605), we proposed to exception to the 2 times rule based on 5 are newly identified APCs. reassign these procedure codes to new the CY 2016 claims data available for Specifically, we found the following 6 APCs that contain services that are the proposed rule. We did not include APCs from the proposed rule continued similar with regard to both their clinical in that determination those APCs where to have violations of the 2 times rule for and resource characteristics. In many a 2 times rule violation was not a this final rule with comment period: cases, the proposed procedure code relevant concept, such as APC 5401 • APC 5112 (Level 2 Musculoskeletal reassignments and associated APC (Dialysis), which only has two HCPCS Procedures); reconfigurations for CY 2018 included codes assigned to it that have similar • APC 5521 (Level 1 Imaging without in the proposed rule are related to geometric mean costs and do not create Contrast); changes in costs of services that were a 2 times rule violation. Therefore, we • APC 5691 (Level 1 Drug observed in the CY 2016 claims data have only identified those APCs, Administration); newly available for CY 2018 ratesetting. including those with criteria-based • APC 5731 (Level 1 Minor We also proposed changes to the status costs, such as device-dependent CPT/ Procedures); indicators for some procedure codes HCPCS codes, with 2 times rule • APC 5771 (Cardiac Rehabilitation); that were not specifically and separately violations. and discussed in the proposed rule. In these We note that, for cases in which a • APC 5823 (Level 3 Health and cases, we proposed to change the status recommendation by the HOP Panel Behavior Services). indicators for these procedure codes appears to result in or allow a violation In addition, we found that the because we believe that another status of the 2 times rule, we may accept the following 5 additional APCs violated indicator would more accurately HOP Panel’s recommendation because the 2 times rule using the final rule with describe their payment status from an those recommendations are based on comment period claims data: OPPS perspective based on the policies explicit consideration (that is, a review • APC 5522 (Level 2 Imaging without that we proposed for CY 2018. of the latest OPPS claims data and group Contrast); Addendum B to the CY 2018 OPPS/ASC discussion of the issue) of resource use, • APC 5524 (Level 4 Imaging without proposed rule identified with the clinical homogeneity, site of service, Contrast); comment indicator ‘‘CH’’ those and the quality of the claims data used • APC 5571 (Level 1 Imaging with procedure codes for which we proposed to determine the APC payment rates. Contrast); a change to the APC assignment or Table 16 of the proposed rule listed • APC 5721 (Level 1 Diagnostic Tests status indicator, or both, that were the 12 APCs for which we proposed to and Related Services); and initially assigned in the July 1, 2017 make exceptions under the 2 times rule • APC 5732 (Level 2 Minor OPPS Addendum B update (available for CY 2018 based on the criteria cited Procedures). via the Internet on the CMS Web site at: above and claims data submitted Comment: Some commenters https://www.cms.gov/Medicare/ between January 1, 2016, and December requested that CMS not adopt the Medicare-Fee-for-Service-Payment/ 31, 2016, that were processed on or exception to C–APCs, including C–APC
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5112 (Level 2 Musculoskeletal if available. We note that, for cases in payment levels and refined the cost Procedures), because they believed it which a recommendation by the HOP bands for these APCs to retain two would result in lowering the payments Panel appears to result in or allow a parallel sets of New Technology APCs, for the procedures assigned to C–APCs. violation of the 2 times rule, we one set with a status indicator of ‘‘S’’ According to the commenters, because generally accept the HOP Panel’s (Significant Procedures, Not Discounted C–APCs involve complex combinations recommendation because those when Multiple. Paid under OPPS; of items and services where appropriate recommendations are based on explicit separate APC payment) and the other set valuation is critical, CMS should not consideration of resource use, clinical with a status indicator of ‘‘T’’ adopt exceptions that have the result of homogeneity, site of service, and the (Significant Procedure, Multiple lowering the overall payment rate for quality of the claims data used to Reduction Applies. Paid under OPPS; associated procedures. Instead, as one determine the APC payment rates. The separate APC payment). These current commenter suggested, CMS should geometric mean costs for hospital New Technology APC configurations establish additional APC levels to avoid outpatient services for these and all allow us to price new technology any exceptions to the 2 times rule. other APCs that were used in the services more appropriately and Response: We do not agree that we development of this final rule with consistently. should establish a new APC for every comment period can be found on the We note that the cost bands for the group that violates the 2 times rule. We CMS Web site at: http://www.cms.gov. New Technology APCs, specifically, believe that excepting certain APCs APCs 1491 through 1599 and 1901 from the 2 times rule is necessary, TABLE 14—APC EXCEPTIONS TO THE through 1906, vary with increments especially for procedures assigned to the 2 TIMES RULE FOR CY 2018 ranging from $10 to $19,999. These cost same APC based on clinical bands identify the APCs to which new homogeneity. As we have seen APC CY 2018 APC title technology procedures and services throughout the years since the with estimated service costs that fall implementation of the OPPS on August 5112 ...... Level 2 Musculoskeletal Proce- within those cost bands are assigned 1, 2000, APCs excepted in one year are dures. under the OPPS. Payment for each APC usually resolved the following year 5521 ...... Level 1 Imaging without Contrast. is made at the mid-point of the APC’s based on our analysis of the latest 5522 ...... Level 2 Imaging without Contrast. assigned cost band. For example, claims data used for ratesetting. For 5524 ...... Level 4 Imaging without Contrast. payment for New Technology APC 1507 5571 ...... Level 1 Imaging with Contrast. example, we listed C–APC 5165 (Level 5691 ...... Level 1 Drug Administration. (New Technology—Level 7 ($501– 5 ENT Procedures) in Table 19 of the CY 5721 ...... Level 1 Diagnostic Tests and Re- $600)) is made at $550.50. 2016 OPPS/ASC final rule with lated. Services Every year, we receive several comment period (80 FR 70374) as one 5731 ...... Level 1 Minor Procedures. requests for higher payment amounts of the APCs that violated the 2 times 5732 ...... Level 2 Minor Procedures. under the New Technology APCs for rule for CY 2016. However, this same 5771 ...... Cardiac Rehabilitation. specific procedures paid under the APC no longer appeared in Table 9 of 5823 ...... Level 3 Health and Behavior OPPS because they require the use of the CY 2017 OPPS/ASC final rule with Services. expensive equipment. As we did in the comment period (81 FR 79614) as CY 2018 OPPS/ASC proposed rule, we excepted from the 2 times rule. We C. New Technology APCs are taking this opportunity to reiterate believe that the anomalies seen in one 1. Background our response, in general, to the issue of year but not the next year for a given hospitals’ capital expenditures as they APC are the result of more accurate In the November 30, 2001 final rule relate to the OPPS and Medicare, as coding and charge master identification (66 FR 59903), we finalized changes to specified in the CY 2016 OPPS/ASC by HOPDs. the time period in which a service can final rule with comment period (80 FR After considering the public be eligible for payment under a New 70374). comments we received on APC Technology APC. Beginning in CY 2002, Under the OPPS, one of our goals is assignments and our analysis of the CY we retain services within New to make payments that are appropriate 2016 costs from hospital claims and cost Technology APC groups until we gather for the services that are necessary for the report data available for this CY 2018 sufficient claims data to enable us to treatment of Medicare beneficiaries. The final rule with comment period, we are assign the service to an appropriate OPPS, like other Medicare payment finalizing our proposals with some clinical APC. This policy allows us to systems, is budget neutral and increases modifications. Specifically, we are move a service from a New Technology are limited to the annual hospital finalizing our proposal to except 6 of the APC in less than 2 years if sufficient inpatient market basket increase. We 12 proposed APCs from the 2 times rule data are available. It also allows us to believe that our payment rates generally for CY 2018 (APCs 5112, 5521, 5691, retain a service in a New Technology reflect the costs that are associated with 5731, 5771, and 5823), and also APC for more than 2 years if sufficient providing care to Medicare excepting 5 additional APCs (APCs data upon which to base a decision for beneficiaries. Furthermore, we believe 5522, 5524, 5571, 5721, and 5732). As reassignment have not been collected. that our payment rates are adequate to noted above, we were able to remedy For CY 2017, there are 51 New ensure access to services (80 FR 70374). the other 6 of the proposed rule 2 time Technology APC levels, ranging from For many emerging technologies, violations in this final rule with the lowest cost band assigned to APC there is a transitional period during comment period. 1491 (New Technology—Level 1A ($0– which utilization may be low, often Table 14 below lists the 11 APCs that $10)) through the highest cost band because providers are first learning we are excepting from the 2 times rule assigned to APC 1906 (New about the techniques and their clinical for CY 2018 based on the criteria Technology—Level 51 ($140,001- utility. Quite often, parties request that described earlier and a review of $160,000)). In the CY 2004 OPPS final Medicare make higher payment updated claims data for dates of service rule with comment period (68 FR amounts under the New Technology between January 1, 2016 and December 63416), we restructured the New APCs for new procedures in that 31, 2016, that were processed on or Technology APCs to make the cost transitional phase. These requests, and before June 30, 2017, and updated CCRs, intervals more consistent across their accompanying estimates for
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expected total patient utilization, often cover hospitals’ costs in a particular Technology APCs. To improve our reflect very low rates of patient use of circumstance, including those for the ability to have payments for services expensive equipment, resulting in high purchase and maintenance of capital over $100,000 more closely match the per use costs for which requesters equipment. We rely on hospitals to cost of the service, in the CY 2018 believe Medicare should make full make their decisions regarding the OPPS/ASC proposed rule (82 FR 33606), payment. Medicare does not, and we acquisition of high-cost equipment with for CY 2018, we proposed to narrow the believe should not, assume the understanding that the Medicare increments for New Technology APCs responsibility for more than its share of program must be careful to establish its 1901–1906 from $19,999 cost bands to the costs of procedures based on initial payment rates, including those $14,999 cost bands. We also proposed to made through New Technology APCs, projected utilization for Medicare add New Technology APCs 1907 and for new services that lack hospital beneficiaries and does not set its 1908 (New Technology Level 52 payment rates based on initial claims data based on realistic utilization projections for all such services ($145,001–$160,000), which would projections of low utilization for allow for an appropriate payment of services that require expensive capital delivered in cost-efficient hospital outpatient settings. As the OPPS retinal prosthesis implantation equipment. For the OPPS, we rely on procedures, which is discussed later in hospitals to make informed business acquires claims data regarding hospital costs associated with new procedures, this section. Table 17 of the proposed decisions regarding the acquisition of rule included the complete list of the high-cost capital equipment, taking into we regularly examine the claims data proposed modified and additional New consideration their knowledge about and any available new information Technology APC groups for CY 2018. their entire patient base (Medicare regarding the clinical aspects of new beneficiaries included) and an procedures to confirm that our OPPS We did not receive any public understanding of Medicare’s and other payments remain appropriate for comments on our proposal. Therefore, payers’ payment policies. (We refer procedures as they transition into we are finalizing the proposal, without readers to the CY 2013 OPPS/ASC final mainstream medical practice (77 FR modification. Table 15 below includes 68314). rule with comment period (77 FR the complete list of the final modified 68314) for further discussion regarding 2. Revised and Additional New and additional New Technology APC this payment policy.) Technology APC Groups groups for CY 2018. We note that, in a budget neutral As stated earlier, for CY 2017, there environment, payments may not fully are currently 51 levels of New
TABLE 15—CY 2018 ADDITIONAL NEW TECHNOLOGY APC GROUPS
CY 2018 APC CY 2018 APC title CY 2018 SI Updated or new APC
1901 ...... New Technology—Level 49 ($100,001–$115,000) ...... S Updated. 1902 ...... New Technology—Level 49 ($100,001–$115,000) ...... T Updated. 1903 ...... New Technology—Level 50 ($115,001–$130,000) ...... S Updated. 1904 ...... New Technology—Level 50 ($115,001–$130,000) ...... T Updated. 1905 ...... New Technology—Level 51 ($130,001–$145,000) ...... S Updated. 1906 ...... New Technology—Level 51 ($130,001–$145,000) ...... T Updated. 1907 ...... New Technology—Level 52 ($145,001–$160,000) ...... S New. 1908 ...... New Technology—Level 52 ($145,001–$160,000) ...... T New.
The final payment rates for New assignment, or where the New more than 2 years if sufficient claims Technology APCs 1901 through 1908 Technology APCs are restructured, we data upon which to base a decision for are included in Addendum A to this may, based on more recent resource reassignment have not been obtained final rule with comment period (which utilization information (including (66 FR 59902). is available via the Internet on the CMS claims data) or the availability of refined Web site). New Technology APC cost bands, a. Magnetic Resonance-Guided Focused reassign the procedure or service to a Ultrasound Surgery (MRgFUS) (APCs 3. Procedures Assigned to New 1537, 5114, and 5414) Technology APC Groups for CY 2018 different New Technology APC that more appropriately reflects its cost (66 As discussed in the CY 2018 OPPS/ As we explained in the CY 2002 OPPS FR 59903). final rule with comment period (66 FR ASC proposed rule (82 FR 33607), 59902), we generally retain a procedure Consistent with our current policy, for currently, there are four CPT/HCPCS in the New Technology APC to which CY 2018, in the CY 2018 OPPS/ASC codes that describe magnetic resonance it is initially assigned until we have proposed rule (82 FR 33606), we image guided high intensity focused obtained sufficient claims data to justify proposed to retain services within New ultrasound (MRgFUS) procedures, three reassignment of the procedure to a Technology APC groups until we obtain of which we proposed to continue to clinically appropriate APC. sufficient claims data to justify assign to standard APCs and one of In addition, in cases where we find reassignment of the service to a which we proposed to continue to that our initial New Technology APC clinically appropriate APC. The assign to a New Technology APC for CY assignment was based on inaccurate or flexibility associated with this policy 2018. These codes include CPT codes inadequate information (although it was allows us to reassign a service from a 0071T, 0072T, and 0398T, and HCPCS the best information available at the New Technology APC in less than 2 code C9734. CPT codes 0071T and time), where we obtain new information years if sufficient claims data are 0072T are used for the treatment of that was not available at the time of our available. It also allows us to retain a uterine fibroids, CPT code 0398T is initial New Technology APC service in a New Technology APC for used for the treatment of essential
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tremor, and HCPCS code C9734 is used ($25,001–$30,000)) or APC 5464 (Level 3 Neurostimulator and Related for pain palliation for metastatic bone 4 Neurostimulator and Related Procedures) would be appropriate. cancer. Procedures), which have payment rates Based on the presence of only one claim As shown in Table 18 of the proposed closer to the reported cost of the along with the reported costs associated rule, and as listed in Addendum B of procedure of $27,500 based on the one with the procedure described by CPT the CY 2018 OPPS/ASC proposed rule, claim available at the time of the code 0398T presented to us last year by we proposed to continue to assign CPT development of the proposed rule. the manufacturer, we believe that it is codes 0071T and 0072T to APC 5414 Commenters also noted that the appropriate to assign the procedure (Level 4 Gynecologic Procedures), with resources required for the procedure described by CPT code 0398T to APC a proposed payment rate of described by CPT code 0398T are 1576 (New Technology—Level 39 approximately $2,189 for CY 2018. We substantially more than the resources ($15,001–$20,000)), with a payment rate also proposed to continue to assign the required for the procedure described by of $17,500.50 for CY 2018. The APC to status indicator ‘‘J1’’ (Hospital CPT code C9734, which had been used continued New Technology APC Part B services paid through a by CMS to attempt to model the cost of assignment will allow time to collect comprehensive APC) to indicate that all the procedure described by CPT code more claims data before assigning CPT covered Part B services on the claim are 0398T. code 0398T to a clinical APC. packaged with the payment for the Response: We appreciate the concerns Comment: One commenter supported of the commenters and, for the reasons primary ‘‘J1’’ service for the claim, the proposal to assign CPT code C9734 set forth below, agree that the proposed except for services assigned to OPPS to APC 5114. status indicator ‘‘F’’, ‘‘G’’, ‘‘H’’, ‘‘L’’, and payment rate for CPT code 0398T may ‘‘U’’; ambulance services; diagnostic and be too low and the procedure should be Response: We appreciate the screening mammography; all preventive reassigned to a different APC. The commenter’s support. services; and certain Part B inpatient proposed payment rate for CPT code In summary, after consideration of the services. In addition, we proposed to 0398T was based on the payment rate public comments we received, we are continue to assign HCPCS code C9734 for HCPCS code C9734 because the modifying our proposal for the APC (Focused ultrasound ablation/ MRgFUS equipment used in the assignment of CPT code 0398T. Instead therapeutic intervention, other than performance of the procedure described of continuing to assign this code to New uterine leiomyomata, with magnetic by CPT code 0398T is very similar to the Technology APC 1537 (New resonance (mr) guidance) to APC 5114 MRgFUS equipment used in the Technology—Level 37 ($9,501– (Level 4 Musculoskeletal Procedures), performance of the procedure described $10,000)), with a payment rate of with a proposed payment rate of by HCPCS code C9734. Both machines $9,750.50, for CY 2018, we are approximately $5,385 for CY 2018. We are made by the same manufacturer (81 reassigning CPT code 0398T to New also proposed to continue to assign FR 79642). However, based on Technology APC 1576 (New HCPCS code C9734 to status indicator information from the manufacturer, Technology—Level 39 ($15,001– ‘‘J1’’. resources involved for the procedure $20,000)), with a payment rate of Further, we proposed to continue to described by CPT code 0398T appear to $17,500.50. In addition, we are assign CPT code 0398T to APC 1537 be higher than those involved for the finalizing our proposal, without (New Technology—Level 37 ($9,501– procedure described by HCPCS code modification, to reassign HCPCS code $10,000)), with a proposed payment rate C9734. In addition, we still have C9734 to APC 5114. We did not receive of $9,750.50 for CY 2018. At the time concerns that the costs reported from any public comments related to our the proposed rule was developed, there the one claim for the procedure proposal for CPT codes 0071T and was only one claim for CPT code 0398T described by CPT code 0398T may not 0072T. Therefore, we are finalizing our with a geometric mean cost of $27,516. accurately reflect the geometric mean proposal to continue to assign these CPT We referred readers to Addendum B to costs of the procedure. However, the codes to APC 5414 without the proposed rule for the proposed geometric mean cost of $29,254 for the modification. Table 16 below lists the payment rates for all codes reportable one claim means the cost of CPT code final CY 2018 status indicator and APC under the OPPS. Addendum B is 0398T is substantially higher than the assignments for the magnetic resonance available via the Internet on the CMS proposed payment rate of $9,750.50. We image guided high intensity focused Web site. note that, for CY 2017, the manufacturer ultrasound (MRgFUS) procedures. We Comment: Several commenters stated indicated that an appropriate payment refer readers to Addendum B of this that the proposed payment rate for CPT for the procedure described by CPT final rule with comment period for the code 0398T is too low and code 0398T would be approximately final payment rates for all codes recommended that CPT code 0398T be $18,000 and that either a New reportable under the OPPS. Addendum assigned to either New Technology APC Technology APC paying that amount or B is available via the Internet on the 1578 (New Technology—Level 41 assignment to clinical APC 5463 (Level CMS Web site.
TABLE 16—CY 2018 STATUS INDICATOR (SI) AND APC ASSIGNMENT FOR THE MAGNETIC RESONANCE IMAGE GUIDED HIGH INTENSITY FOCUSED ULTRASOUND (MRGFUS) PROCEDURES
CY 2017 CPT/HCPCS CY 2017 CY 2017 OPPS CY 2018 CY 2018 CY 2018 OPPS code Long descriptor OPPS SI OPPS APC payment OPPS SI OPPS APC payment rate rate
0071T ...... Focused ultrasound ablation of J1 5414 $2,084.59 J1 5414 Refer to OPPS uterine leiomyomata, including Addendum B. mr guidance; total leiomyomata volume less than 200 cc of tis- sue.
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TABLE 16—CY 2018 STATUS INDICATOR (SI) AND APC ASSIGNMENT FOR THE MAGNETIC RESONANCE IMAGE GUIDED HIGH INTENSITY FOCUSED ULTRASOUND (MRGFUS) PROCEDURES—Continued
CY 2017 CPT/HCPCS CY 2017 CY 2017 OPPS CY 2018 CY 2018 CY 2018 OPPS code Long descriptor OPPS SI OPPS APC payment OPPS SI OPPS APC payment rate rate
0072T ...... Focused ultrasound ablation of J1 5414 2,084.59 J1 5414 Refer to OPPS uterine leiomyomata, including Addendum B. mr guidance; total leiomyomata volume greater or equal to 200 cc of tissue. 0398T ...... Magnetic resonance image guid- S 1537 9,750.50 S 1576 Refer to OPPS ed high intensity focused Addendum B. ultrasound (mrgfus), stereotactic ablation lesion, intracranial for movement dis- order including stereotactic navigation and frame place- ment when performed. C9734 ...... Focused ultrasound ablation/ J1 5114 5,219.36 J1 5114 Refer to OPPS therapeutic intervention, other Addendum B. than uterine leiomyomata, with magnetic resonance (mr) guid- ance.
c. Retinal Prosthesis Implant Procedure payment rate for the procedure 2018 OPPS/ASC final rule with ® CPT code 0100T (Placement of a involving the Argus II System was comment period, the final payment rate subconjunctival retinal prosthesis insufficient to cover the hospital cost of would be based on claims submitted receiver and pulse generator, and performing the procedure, which between January 1, 2016 and December implantation of intra-ocular retinal includes the cost of the retinal 31, 2016, and processed through June electrode array, with vitrectomy) prosthesis with a retail price of 30, 2017. describes the implantation of a retinal approximately $145,000. In the proposed rule, based on the CY prosthesis, specifically, a procedure For CY 2017, analysis of the CY 2015 2016 OPPS claims data available, which involving the use of the Argus® II OPPS claims data used for the CY 2017 showed a geometric mean cost of Retinal Prosthesis System. This first final rule with comment period showed approximately $116,239, we proposed ® retinal prosthesis was approved by the 9 single claims (out of 13 total claims) to reassign the Argus II procedure to a FDA in 2013 for adult patients for CPT code 0100T, with a geometric New Technology APC with a payment diagnosed with advanced retinitis mean cost of approximately $142,003 band that covers the geometric mean pigmentosa. Pass-through payment based on claims submitted between cost of the procedure. Therefore, we status was granted for the Argus® II January 1, 2015, through December 31, proposed to reassign CPT code 0100T to device under HCPCS code C1841 2015, and processed through June 30, APC 1904 (New Technology—Level 50 (Retinal prosthesis, includes all internal 2016. Based on the CY 2015 OPPS ($115,001–$130,000)), with a proposed and external components) beginning claims data available for the final rule payment of $122,500.50 for CY 2018. October 1, 2013, and this status expired with comment period and our We invited public comments on this ® on December 31, 2015. We note that understanding of the Argus II proposal. after pass-through payment status procedure, we reassigned CPT code Comment: One commenter, the expires for a medical device, the 0100T from New Technology APC 1599 manufacturer, opposed the proposal to payment for the device is packaged into to New Technology APC 1906, with a reassign CPT code 0100T to APC 1904, the payment for the associated surgical final payment rate of $150,000.50 for CY with a proposed payment of procedure. Consequently, for CY 2016, 2017. We noted that this payment rate $122,500.50 for CY 2018. Instead, the the device described by HCPCS code included the cost of both the surgical commenter requested that CMS reassign C1841 was assigned to OPPS status procedure (CPT code 0100T) and the CPT code 0100T to a New Technology indicator ‘‘N’’ to indicate that payment retinal prosthesis device (HCPCS code APC that would establish a payment for the device is packaged and included C1841). rate near the CY 2017 payment rate of in the payment rate for the surgical As discussed in the CY 2018 OPPS/ $150,000.50. The commenter stated that procedure described by CPT code ASC proposed rule (82 FR 33607 the estimated cost of the service 0100T. For CY 2016, CPT code 0100T through 33608), for the CY 2018 update, generated from 3 claims reported in CY was assigned to New Technology APC analysis of the CY 2016 OPPS claims 2016 is much lower than the actual cost 1599 with a payment rate of $95,000, data used for the CY 2018 proposed rule of the procedure. The commenter which was the highest paying New showed 3 single claims (out of 3 total believed the lower cost of the procedure Technology APC for that year. This claims) for CPT code 0100T, with a described by CPT code 0100T is a result payment includes both the surgical geometric mean cost of approximately of CMS’ decision to set the payment rate procedure (CPT code 0100T) and the $116,239 based on the claims submitted of the procedure at $95,000 for CY 2016 use of the Argus® II device (HCPCS code between January 1, 2016 through based on 2 claims, for which the C1841). However, stakeholders December 31, 2016, and processed submitting hospital stated the charges (including the device manufacturer and through December 31, 2016. We stated reported were mistakenly low. The hospitals) believed that the CY 2016 in the proposed rule that, for the CY commenter asserted that the lower
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payment rate forced the manufacturer of proposed payment rate of $122,500.50 is d. Pathogen Test for Platelets the Argus® II to provide a substantial a significant decrease, we believe that it discount for the device, which is would be appropriate to finalize the As stated in the CY 2018 OPPS/ASC reflected in the lower reported cost for proposed rate to mitigate a much proposed rule (82 FR 33608), the CMS the Argus® II procedure in CY 2016. sharper decline in payment from one HCPCS Workgroup established HCPCS This commenter and a second year to the next (as well as from the code Q9987 (Pathogen(s) test for commenter were concerned with the proposed rule to the final rule). platelets), effective July 1, 2017. HCPCS high level of variation in payment for a In accordance with section code Q9987 will be used to report any low volume service like the Argus® II 1833(t)(2)(B) of the Act, we must test used to identify bacterial or other procedure from year to year. The establish that services classified within pathogen contamination in blood commenters requested payment of each APC are comparable clinically and platelets. Currently, there is one test approximately $150,000 for CPT code with respect to the use of resources. approved by the FDA that is described 0100T in CY 2018 to break the cycle of Accordingly, we are using our equitable by HCPCS code Q9987. The test is a extremely volatile year-to-year shifts of adjustment authority under section rapid bacterial test, and the the payment for the procedure described 1833(t)(2)(E) of the Act, which states manufacturer estimates the cost of the by this CPT code and noted its that the Secretary shall establish, in a test to be between $26 and $35. HCPCS expectation that claims for CY 2017 budget neutral manner, other code Q9987 was established after (which would be used for the CY 2019 adjustments as determined to be concerns from blood and blood product rulemaking) would reflect a necessary to ensure equitable payments, stakeholders that the previous CPT code significantly higher average cost than to maintain the proposed rate for this used to describe pathogen tests for those for CY 2016. procedure, despite the lower geometric platelets, CPT code P9072 (Platelets, mean costs available in the claims data Response: We understand the pheresis, pathogen reduced or rapid used for this final rule with comment concerns of the commenters. The bacterial tested, each unit), ® period. As stated earlier, we believe that inappropriately described rapid reported cost of the Argus II procedure this situation is unique, given the high based on the updated CY 2016 hospital bacterial testing by combining the test cost and very limited number of claims with the pathogen reduction of platelets. outpatient claims data, which include for the procedure. Therefore, for CY additional claims received after ® CPT code P9072 is inactive effective on 2018, we are reassigning the Argus II July 1, 2017. issuance of the CY 2018 proposed rule procedure to APC 1904 (New and finalized as of June 30, 2017, is Technology—Level 50 ($115,001– In the CY 2018 OPPS/ASC proposed approximately $94,455, which is more $130,000)). This APC assignment will rule, we sought more information on the than $55,000 less than the payment rate establish a payment rate for the Argus® actual costs of pathogen tests for for the procedure in CY 2017. We note platelets before assigning HCPCS code ® II procedure of $122,500.50, which is that the costs of the Argus II procedure the arithmetic mean of the payment Q9987 to a clinical APC. Effective July are extraordinarily high compared to rates for the service for CY 2016 and CY 1, 2017, HCPCS code Q9987 is assigned many other procedures paid under the 2017. As we do each year, we acquire to New Technology APC 1493 (New OPPS. In addition, the number of claims claims data regarding hospital costs Technology—Level 1C ($21–$30)), with submitted has, to date, been very low associated with new procedures. We a payment rate of $25.50. We proposed and has not exceeded 10 claims. We regularly examine the claims data and to continue to assign HCPCS code believe it is important to mitigate any available new information regarding Q9987 to New Technology APC 1493, significant payment differences, the clinical aspects of new procedures with a proposed payment rate of $25.50, especially shifts of several tens of to confirm that our OPPS payments until such time as claims data are thousands of dollars, while also basing remain appropriate for procedures like available to support the assignment to a payment rates on available costs the Argus® II procedure as they clinical APC. We invited public information and claims data. In CY transition into mainstream medical comments on this proposal. ® 2016, the payment rate for the Argus practice (77 FR 68314). Comment: Two commenters II procedure was $95,000.50. The After consideration of the public supported the proposal to continue to payment rate increased to $150,000.50 comments we received, we are provide separate payment for HCPCS in CY 2017. For CY 2018, we proposed finalizing our proposal to reassign CPT code Q9987. a payment rate of $122,500.50 based on code 0100T to APC 1904 through use of the most recent claims data available at our equitable adjustment authority. We Response: We appreciate the the time of the development of the are reassigning CPT code 0100T from commenters’ support. proposed rule. However, if we were to APC 1906 (New Technology—Level 51 After consideration of the public assign the payment rate based on ($140,001–$160,000)), which has a final comments we received, we are updated final rule claims data, the payment rate of $150,000.50 for CY finalizing our proposal to continue payment rate would decrease, to 2017, to APC 1904 (New Technology— separate payment for HCPCS code $95,000.50 for CY 2018, a decrease of Level 50 $115,001–$130,000)), which Q9987 for CY 2018, with a modification $55,000 relative to CY 2017. We are has a final payment rate of $122,500.50 that HCPCS code Q9987 will be concerned that these large changes in for CY 2018. We note this payment replaced by HCPCS code P9100 payment could potentially create an includes both the surgical procedure (Pathogen(s) test for platelets). Table 17 access to care issue for the Argus® II (CPT code 0100T) and the use of the below contains more information on the procedure. While we believe that the Argus® II device (HCPCS code C1841). coding change.
TABLE 17—REPLACEMENT CODE FOR HCPCS CODE Q9987 AS OF JANUARY 1, 2018
CY 2017 CY 2018 Final CY Final CY HCPCS code HCPCS code CY 2018 long descriptor 2018 SI 2018 APC
Q9987 ...... P9100 ...... Pathogen(s) test for platelets ...... S 1493
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e. Fractional Flow Reserve Derived proposed APC assignment; comments code numbers would be included in this From Computed Tomography (FFRCT) will be accepted on the proposed APC CY 2018 OPPS/ASC final rule with assignment for the new code). comment period. The final CPT code For CY 2018, the AMA CPT Editorial Addendum O included the proposed/ numbers, along with their Panel established four new CPT codes placeholder CY 2018 CPT codes and the corresponding 5-digit placeholder for fractional flow reserve derived from long descriptors. codes, can be found in Table 19 below. computed tomography (FFRCT). Table We note that the CPT code descriptors 18 below lists the new CPT codes along that appeared in Addendum B were As displayed in Table 18 and in with their complete descriptors. These short descriptors and did not fully Addendum B of the CY 2018 OPPS/ASC codes were listed in Addendum B and describe the complete procedure, proposed rule, we proposed to assign Addendum O to the CY 2018 OPPS/ASC service, or item identified for the CPT CPT codes 0501T and 0504T to status proposed rule (which is available via codes. Therefore, we included the 5- indicator ‘‘M’’ (Not paid under OPPS; the Internet on the CMS Web site). digit placeholder codes and their long Items and Services Not Billable to the Addendum B included the proposed descriptors in Addendum O to the MAC) to indicate that these services are status indicator assignments for the new proposed rule, specifically under the not paid under the OPPS, and to assign codes and their assignment to comment column labeled ‘‘CY 2018 OPPS/ASC CPT codes 0502T and 0503T to status indicator ‘‘NP’’ (New code for the next Proposed Rule 5-Digit AMA Placeholder indicator ‘‘N’’ (packaged) to indicate calendar year or existing code with Code,’’ so that the public could that the payment for these services is substantial revision to its code adequately comment on our proposed packaged into the primary service or descriptor in the next calendar year as APC and status indicator assignments. procedure that is reported with the compared to current calendar year, We also indicated that the final CPT codes.
TABLE 18—PROPOSED CY 2018 STATUS INDICATOR (SI) ASSIGNMENT FOR THE NEW FFRCT CPT CODES EFFECTIVE JANUARY 1, 2018
CY 2018 OPPS/ASC Proposed Proposed Proposed CPT code proposed rule Long descriptor CY 2018 CY 2018 CY 2018 placeholder OPPS SI OPPS APC OPPS code payment
0501T ...... 02X4T ...... Non-invasive estimated coronary fractional flow reserve (FFR) M N/A N/A derived from coronary computed tomography angiography data using computation fluid dynamics physiologic simulation soft- ware analysis of functional data to assess the severity of coro- nary artery disease; data preparation and transmission, anal- ysis of fluid dynamics and simulated maximal coronary hyper- emia, generation of estimated FFR model, with anatomical data review in comparison with estimated FFR model to rec- oncile discordant data, interpretation and report. 0502T ...... 02X5T ...... Non-invasive estimated coronary fractional flow reserve (FFR) N N/A N/A derived from coronary computed tomography angiography data using computation fluid dynamics physiologic simulation soft- ware analysis of functional data to assess the severity of coro- nary artery disease; data preparation and transmission. 0503T ...... 02X6T ...... Non-invasive estimated coronary fractional flow reserve (FFR) N N/A N/A derived from coronary computed tomography angiography data using computation fluid dynamics physiologic simulation soft- ware analysis of functional data to assess the severity of coro- nary artery disease; analysis of fluid dynamics and simulated maximal coronary hyperemia, and generation of estimated FFR model. 0504T ...... 02X7T ...... Non-invasive estimated coronary fractional flow reserve (FFR) M N/A N/A derived from coronary computed tomography angiography data using computation fluid dynamics physiologic simulation soft- ware analysis of functional data to assess the severity of coro- nary artery disease; anatomical data review in comparison with estimated FFR model to reconcile discordant data, interpreta- tion and report.
According to the FDA, FFRCT uses the outpatient hospital setting by report is generated that provides post-processing software to create ‘‘a HeartFlow, which uses proprietary fractional flow reserve values mathematically derived quantity, software to conduct the analysis. throughout the coronary blood vessels, computed from simulated pressure, Hospital outpatient providers use which allows providers to determine velocity and blood flow information industry-leading protocols and treatment strategies based on the obtained from a 3D computer model technologies at every step to ensure findings of the report while considering generated from static coronary CT protection of patient data and that the the patient’s medical history, symptoms, 1 images.’’ FFRCT is performed outside CT images are securely transferred to and results of other diagnostic tests. 2 HeartFlow. After FFRCT is performed, a The developer of FFRCT first 1 Available at: https://www.accessdata.fda.gov/ submitted an application for the cdrh_docs/reviews/DEN130045.pdf, page 1. 2 Available at: http://www.heartflow.com/. procedure to be given a temporary
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procedure code and assigned to a New that new CPT codes 0501T, 0502T, properly interpret the regulation at 42 Technology APC in March 2016. CMS 0503T, and 0504T be established for CFR 419.2(b)(13) in its previous denied the developer’s application FFRCT services, effective January 1, decisions to deny the FFRCT application because we considered the FFRCT 2018. The commenters stated that the and reconsideration request to receive procedure to be an image guidance, physician societies and the AMA separate payment in a New Technology processing, supervision, or determined that a coronary computed APC. Specifically, the FFRCT developer interpretation service whose payment tomography angiography and a FFRCT and other commenters stated that the should be packaged into the payment service are not connected services. FFRCT service was not an image for the related computed tomography Commenters asserted that a FFRCT guidance service because CMS stated in service, in accordance with our service provides information that cannot prior preamble language that an image regulations at 42 CFR 419.2(b)(13). The be obtained from standard analysis of a guidance service must produce images. developer then filed a New Technology coronary computed tomography The commenters stated that a FFRCT APC reconsideration request in March angiography image. Several commenters service does not produce images, but 2017 asking that CMS reverse its denial stated that FFRCT services can improve instead produces FFR values. They of the developer’s application to have the quality of screening for coronary stated that the FFRCT service is also not the FFRCT assigned to a New artery disease (CAD) while reducing an image processing service because Technology APC. We reviewed the costs. That is, the commenters stated such processing services help to reconsideration request and denied the that, unlike a coronary computed compile diagnostic data to create an request for the same reason as we did in tomography angiography service, which image, and noted that, although the March 2016. merely produces images, the FFRCT FFRCT service analyzes image data, it is In a New Technology APC application service is able to directly produce FFRCT not used to construct an anatomic for HeartFlow for CY 2018, the values by creating a 3-D model of the image. In addition, the commenters developer of the FFRCT service proposed patient’s coronary arteries using the asserted that the FFRCT service is not an that the service be reported with CPT previously acquired image. Moreover, imaging supervision or interpretation code 0503T (Non-invasive estimated the commenters contended that, because service. The commenters believed that coronary fractional flow reserve (FFR) the FFRCT service does not produce imaging supervision and interpretation derived from coronary computed images, it is improper to package the services should be performed on the tomography angiography data using costs of FFRCT into the payment for the same day and at the provider location as computation fluid dynamics physiologic associated coronary computed the independent imaging service; simulation software analysis of tomography angiography service. whereas the FFRCT service can be functional data to assess the severity of Commenters stated that, many times, performed days or weeks after the coronary artery disease; analysis of fluid a coronary computed tomography original coronary computed tomography dynamics and simulated maximal angiography indicates that a beneficiary angiography service is performed and is coronary hyperemia, and generation of may potentially have CAD and that performed in a specialized location estimated FFR model) and requested without FFRCT, providers will often outside of hospital. In addition, the that the service be assigned to APC 1517 request an invasive coronary angiogram commenters stated that imaging (New Technology—Level 17 ($1,501– to verify the presence of CAD. In many supervision and interpretation services $1,600)), with a payment rate of cases, the invasive coronary angiogram are for radiological services that are $1,550.50. Because both the initial New finds no occurrence of CAD. FFRCT mostly billed with the CPT radiological Technology APC application and the services can provide analytic services code set (CPT codes 70000–79999) and reconsideration request were denied, we not otherwise available to determine the FFRCT service is not a radiological did not describe the associated New fractional flow rates in coronary arteries service and does not involve Technology APC application for using the original coronary computed supervision or interpretation. HeartFlow in the CY 2018 OPPS/ASC tomography angiography image and Response: We appreciate the proposed rule. show whether a beneficiary has CAD comments we have received about the Comment: Several commenters, without performing a coronary FFRCT service. We have reviewed our including the developer of HeartFlow procedure. image packaging regulations under 42 and some clinicians who have The developer also stated that CFR 419.2(b)(13). This regulation states, experience with it, supported having a hospitals incur a cost charged by in relevant part, that in determining the FFRCT service paid as a separate service HeartFlow of $1,500 to perform the packaged costs for hospital outpatient and not packaged into the payment for FFRCT analysis, and certain other prospective payment rates, the the coronary computed tomography modest costs (for example, overhead for prospective payment system establishes angiography. The commenters stated interpretation and entering results into a national payment rate, standardized that FFRCT is performed separately from medical record). Therefore, the for geographic wage differences, that a coronary computed tomography commenters stated that bundling the includes operating and capital-related angiography by an independent testing payment for FFRCT with the payment for costs that are integral, ancillary, company that is not affiliated with any the coronary computed tomography supportive, dependent, or adjunctive to outpatient hospital provider and is angiography imaging service would performing a procedure or furnishing a performed at locations owned by the prevent hospitals from using FFRCT service on an outpatient basis. In testing company. These commenters because the payment rate for the general, these packaged costs may noted that the service may be performed bundled coronary computed include, but are not limited to, among several days or weeks after the original tomography angiography service would other items and services, image coronary computed tomography be less than $300. One commenter (the guidance, processing, supervision, and angiography is performed. Also, developer) requested that the service be interpretation services, the payment for commenters noted that several assigned to APC 1517 (New which are packaged or conditionally physician societies involved in cardiac Technology—Level 17 ($1,501–$1,600)), packaged into the payment for the care recognize FFRCT as a separate with a payment rate of $1,550.50. related procedures or services. service from a coronary computed Some commenters, including the After reviewing the public comments, tomography angiography and requested developer, stated that CMS did not we agree with the commenters that the
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FFRCT service is not image guidance or prior image acquired by the hospital for information about the function of the supervision because FFRCT does not the patient and is used for the same coronary arteries produced by the FFRCT produce images, does not appear to be purpose to diagnose CAD. service is not possible to derive from a supportive guidance service that aids With respect to imaging examining anatomic images of the in the performance of an independent interpretation, as stated in the CY 2008 arteries. Additionally, we agree with the procedure, and, unlike typical OPPS/ASC final rule with comment commenters that the FFRCT service does supervision services, is not generally period (72 FR 66630), we define not support the diagnostic output of reported when the initial image is ‘‘imaging supervision and interpretation CCTA. Notably, CPT code 0503T does acquired. However, we are concerned codes’’ as HCPCS codes for services that not mention processing, interpretation, that it may be image processing and/or are defined as ‘‘radiological supervision or supervision. Further, the FDA interpretation. We discuss these and interpretation’’ in the radiology clearance refers to the FFRCT service as concerns below. series, codes 70000 through 79999 of the ‘‘post-processing image analysis With respect to image processing, in book of AMA CPT codes, with the software . . . using graphics and text the CY 2008 OPPS/ASC interim and addition of some services in other code [FFRCT] to aid the clinician in the final rule with comment period, we ranges of CPT, Category III CPT tracking assessment of coronary artery disease.’’ stated that an ‘‘image processing service codes, or Level II HCPCS codes that are Therefore, we conclude, based on the processes and integrates diagnostic test clinically similar or directly crosswalk information available to us at this time, data that were captured during another to codes defined as radiological that the costs of the FFRCT service, as independent procedure, usually one supervision and interpretation services described by CPT code 0503T, should that is separately payable under the in the CPT radiology range. The current not be a packaged service under the OPPS. The image processing service is CPT FFRCT codes are Category III codes, regulation at 42 CFR 419.2(b)(13). not necessarily provided on the same and we believe they may be clinically Accordingly, we are assigning CPT code date of service as the independent similar to codes in the 70000 through 0503T to a New Technology APC for CY procedure. In fact, several of the image 79999 range of the AMA book of CPT 2018. We remind hospitals that, processing services that we proposed to codes. according to the Medicare statute, this package for CY 2008 do not need to be Nonetheless, we were persuaded by service should only be furnished when provided face-to-face with the patient in the commenters that the FFRCT service reasonable and medically necessary for the same encounter as the independent is a separate and distinct service from the purposes of diagnosis of and service’’ (72 FR 66625). In addition, we the original coronary computed treatment a Medicare beneficiary. stated that we believed it was important tomography angiography service and In summary, after consideration of the to package payment for supportive should receive separate payment. public comments we received, we are dependent services that accompany Specifically, the commenters provided finalizing our proposal for CPT codes independent services but that may not additional details since the denial of the 0501T, 0502T, and 0504T without need to be provided face-to-face with new technology reconsideration request modification. However, for CPT code the patient in the same encounter that FFRCT is not covered by the image 0503T, we are finalizing our proposal because the supportive services utilize packaging regulations under 42 CFR with modification. Specifically, we are data that were collected during the 419.2(b)(13). Most of the additional reassigning CPT code 0503T from preceding independent services and detail focuses on whether FFRCT is an packaged status (status indicator ‘‘N’’) to packaging their payment encourages the image processing service. In particular, New Technology APC 1516 (New most efficient use of hospital resources. the FFRCT service generates data on FFR Technology—Level 16 ($1,401–$1,500)), We noted that we were particularly values that can only be obtained by with a payment rate of $1,450.50 for CY concerned with any OPPS payment performing the FFRCT service. 2018. We note our belief that CPT code policies that could encourage certain Accordingly, we now believe that the 0503T covers payment for the majority inefficient and more costly service FFRCT service should not be considered of hospital resources involved in the patterns. In addition, we stated that to be an image processing service HeartFlow service, and that CPT 0502T, packaging encourages hospitals to because the diagnostic output of the which reflects data preparation and establish protocols that ensure that FFRCT service yields functional values transmission, will be packaged under services are furnished only when they (that is, FFR values), which reflect the the OPPS. are medically necessary and to carefully drop in pressure across a narrowing in Table 19 lists the final status indicator scrutinize the services ordered by a coronary artery as opposed to assignments for CPT codes 0501T, practitioners to minimize unnecessary anatomic images. The CY 2008 OPPS/ 0502T, 0503T, and 0504T. We refer use of hospital resources (72 FR 66625). ASC final rule with comment period (72 readers to Addendum B to this final rule FFRCT services necessarily require the FR 66625) states that image processing with comment period for the payment use of the prior coronary computed covers ‘‘supportive dependent services rates for all codes reported under the tomography angiography image; the fact to process and integrate diagnostic test OPPS. In addition, we refer readers to that the FFRCT service is done on a data in the development of images, Addendum A to this final rule with different date, at a different site, and by indicating that an image processing comment period for the status indicator nonhospital staff does not, in and of service must help develop or otherwise meanings for all codes reported under itself, mean that the service is separate visually enhance an image and the the OPPS. Both Addendum A and B are and distinct, from the CCTA. This is FFRCT service does neither. Further, we available via the Internet on the CMS especially true because it is using a agree that the quantitative diagnostic Web site.
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TABLE 19—FINAL CY 2018 STATUS INDICATOR (SI) ASSIGNMENT FOR THE NEW FFRCT CPT CODES EFFECTIVE JANUARY 1, 2018
CY 2018 OPPS/ASC CPT code proposed rule Long descriptor CY 2018 CY 2018 CY 2018 OPPS placeholder OPPS SI OPPS APC payment code
0501T ...... 02X4T ...... Non-invasive estimated coronary fractional flow reserve M N/A N/A. (FFR) derived from coronary computed tomography angiography data using computation fluid dynamics physiologic simulation software analysis of functional data to assess the severity of coronary artery dis- ease; data preparation and transmission, analysis of fluid dynamics and simulated maximal coronary hy- peremia, generation of estimated FFR model, with an- atomical data review in comparison with estimated FFR model to reconcile discordant data, interpretation and report. 0502T ...... 02X5T ...... Non-invasive estimated coronary fractional flow reserve N N/A N/A. (FFR) derived from coronary computed tomography angiography data using computation fluid dynamics physiologic simulation software analysis of functional data to assess the severity of coronary artery dis- ease; data preparation and transmission. 0503T ...... 02X6T ...... Non-invasive estimated coronary fractional flow reserve S 1516 Refer to OPPS (FFR) derived from coronary computed tomography Addendum B. angiography data using computation fluid dynamics physiologic simulation software analysis of functional data to assess the severity of coronary artery dis- ease; analysis of fluid dynamics and simulated maxi- mal coronary hyperemia, and generation of estimated FFR model. 0504T ...... 02X7T ...... Non-invasive estimated coronary fractional flow reserve M N/A N/A. (FFR) derived from coronary computed tomography angiography data using computation fluid dynamics physiologic simulation software analysis of functional data to assess the severity of coronary artery dis- ease; anatomical data review in comparison with esti- mated FFR model to reconcile discordant data, inter- pretation and report.
D. OPPS APC-Specific Policies the transplant procedure (HCPCS code ‘‘B’’ to ‘‘S’’, which indicates that the 38240 (Hematopoietic progenitor (HPC); procedure is paid under the OPPS and 1. Blood-Derived Hematopoietic Cell allogeneic transplantation per donor)) in receives separate payment. Harvesting order to be appropriately packaged for The CY 2016 claims data used for the HCPCS code 38205 describes blood- payment purposes. Hospitals are proposed rule, which included claims derived hematopoietic progenitor cell instructed to identify services required submitted between January 1, 2016, and harvesting for transplantation, per to acquire stem cells from a donor for December 31, 2016, and processed on or collection; allogeneic. This code allogeneic HSCT separately in Field 42 before December 31, 2016, showed a represents a donor acquisition cost for on Form CMS–1450 (or UB–04), with geometric mean cost of approximately an allogeneic hematopoietic stem cell revenue code 0815 when an allogeneic $580 for HCPCS code 38205 based on 2 transplant (HSCT). In the CY 2010 stem cell transplant occurs. (We refer single claims (out of 8 total claims). The OPPS/ASC final rule with comment readers to the Medicare Claims procedure described by HCPCS code period (74 FR 60575), we assigned Processing Manual (Pub. 100–04), 38205 has resource and clinical HCPCS code 38205 to status indicator Chapter 4, Section 231.11, and Chapter similarities to procedures assigned to ‘‘B’’, which indicates that this code is 3, Section 90.3.1.) APC 5242 (Level 2 Blood Product not recognized by the OPPS when There are other donor acquisition Exchange and Related Services). submitted on an outpatient hospital Part costs, namely those costs for the Therefore, we proposed to assign B bill (type 12x and 13x). procedure described by HCPCS code HCPCS code 38205 to APC 5242. We In CY 2017, we finalized a C–APC for 38230 (Bone marrow harvesting for invited public comments on these HSCT (81 FR 79586 through 79587). transplantation; allogeneic), that are proposals. Payment for donor acquisition services assigned to status indicator ‘‘S’’. For Comment: Several commenters for HSCT is included in the C–APC consistency and to ensure that the donor opposed the proposal to change the payment for the allogeneic stem cell acquisition costs are captured status indicator assignment for the transplant when the transplant occurs in accurately, in the CY 2018 OPPS/ASC procedure described by HCPCS code the hospital outpatient setting. All proposed rule (82 FR 33608), for CY 38205 from ‘‘B’’ to ‘‘S’’. The commenters donor acquisition costs, including the 2018, we proposed to change the status stated that this procedure represents a costs for HCPCS code 38205, should be indicator assignment for the procedure donor acquisition cost for allogeneic reported on the same date of service as described by HCPCS code 38205 from hematopoietic stem cell transplants for
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which Medicare does not make separate series of bone marrow and stem cell finalizing our proposal to change the payment because hospitals may bill and transplant-related CPT codes to ensure status indicator assignment for the receive payment only for services consistency in terms of coding, billing procedure described by HCPCS code provided to the Medicare beneficiary guidance, appropriate APC assignment, 38205 from ‘‘B’’ to ‘‘S’’ and to assign who is the recipient of the stem cell and payment. HCPCS code 38205 to APC 5242. transplant and whose illness is being Response: We appreciate the commenters’ responses. We believed 2. Brachytherapy Insertion Procedures treated with the stem cell transplant. (C–APCs 5341 and 5092) The commenters believed that a change that changing the status indicator assignment from ‘‘B’’ to ‘‘S’’ for HCPCS from status indicator ‘‘B’’ to ‘‘S’’ may a. C–APC 5341 (Abdominal/Peritoneal/ code 38205 would be consistent with indicate to providers that they can bill Biliary and Related Procedures) other donor acquisition costs and ensure donors for these services and lead to that the donor acquisition costs for For CY 2018, as displayed in Table 20 potential for erroneous separate allogeneic HSCT are captured below and in Addendum B to the CY payments if this code is billed with accurately. However, we agree with the 2018 OPPS/ASC proposed rule, we status indicator ‘‘S’’. In addition, the commenters that this change could proposed to continue to assign CPT HOP Panel recommended that CMS result in erroneous billing or code 55920 to C–APC 5341 (Abdominal/ retain status indicator ‘‘B’’ for HCPCS misinterpretations by providers. Peritoneal/Biliary and Related code 38205. The commenters also After consideration of the public Procedures), with a proposed payment encouraged CMS to look at the entire comments we received, we are not rate of $2,788.26.
TABLE 20—PROPOSED CY 2018 STATUS INDICATOR (SI), APC ASSIGNMENT, AND PAYMENT RATE FOR CPT CODE 55920
Proposed CY 2017 Proposed Proposed CY 2018 CPT code Long descriptor CY 2017 CY 2017 OPPS CY 2018 CY 2018 OPPS OPPS SI OPPS APC payment OPPS SI OPPS APC payment rate rate
55920 ...... Placement of needles or catheters J1 5341 $2,861.53 J1 5341 $2,788.26 into pelvic organs and/or genitalia (except prostate) for subsequent in- terstitial radioelement application.
Comment: Commenters disagreed geometric mean cost of approximately codes reported under the OPPS. In with the proposed APC assignment for $4,791 for CPT code 55920 based on 134 addition, we refer readers to Addendum CPT code 55920 and recommended that single claims (out of 135 total claims), A to this final rule with comment period this code be reassigned to an APC that which is comparable to the geometric for the status indicator meanings for all includes gynecologic procedures, mean cost of approximately $4,109 for codes reported under the OPPS for CY specifically C–APC 5415 (Level 5 C–APC 5415. The geometric mean cost 2018. Both Addendum A and Gynecologic Procedures). The for C–APC 5341 is approximately Addendum B are available via the commenters noted that radiation $2,909. After reviewing the procedures Internet on the CMS Web site. therapy is an important adjuvant assigned to C–APC 5415, we agree with treatment for gynecological the commenters that CPT code 55920 b. C–APC 5092 (Level 2 Breast/ malignancies and the vignette for the would be more appropriately reassigned Lymphatic Surgery and Related procedure described by CPT 55920 to C–APC 5415 based on its clinical Procedures) describes a gynecological implant with homogeneity and resource costs. a Syed-type intracavitary applicator After consideration of the public For CY 2018, as displayed in Table 21 insertion to the vagina, cervix, or female comments we received, we are below and in Addendum B to the CY urethra. The commenters stated that the finalizing our CY 2018 proposal with 2018 OPPS/ASC proposed rule, we procedure described by CPT code 55920 modification. Specifically, we are proposed to continue to assign CPT was similar, from a clinical and resource reassigning CPT code 55920 from C– code 19298 to C–APC 5092 (Level 2 perspective, to procedures assigned to APC 5341 to C–APC 5415 for CY 2018. Breast/Lymphatic Surgery and Related C–APC 5415. We refer readers to Addendum B to this Procedures), with a proposed payment Response: Our analysis of the final final rule with comment period for the rate of $4,616.48. rule updated claims data revealed a final CY 2018 payment rates for all
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TABLE 21—PROPOSED CY 2018 STATUS INDICATOR (SI), APC ASSIGNMENT, AND PAYMENT RATE FOR CPT CODE 19298
Proposed CY 2017 Proposed Proposed CY 2018 CPT code Long descriptor CY 2017 CY 2017 OPPS CY 2018 CY 2018 OPPS OPPS SI OPPS APC payment OPPS SI OPPS APC payment rate rate
19298 ...... Placement of radiotherapy J1 5092 $4,417.60 J1 5092 $4,616.48 afterloading brachytherapy cath- eters (multiple tube and button type) into breast for interstitial; radioelement application following (at the time of or subsequent to) partial mastectomy, includes image guidance).
Comment: Commenters disagreed approximately $5,944 for CPT code 2018 payment rates for the replacement with the proposed continued APC 19298 is within the range of the codes. assignment for CPT code 19298 to significant procedures assigned to Comment: Commenters supported C–APC 5092. These commenters stated C–APC 5092, which is between $4,276 CMS’ proposed replacement codes for that the CY 2018 proposed payment is (for CPT code 19380) and $6,134 (for CY 2018 for several of the care inadequate and does not cover the costs CPT code 19340). management services finalized for CY associated with the surgical placement After consideration of the public 2017. One commenter recommended of the breast brachytherapy catheter or comments we received and based on that the new chronic care management the brachytherapy treatment delivery updated claims data, we are finalizing codes be removed from the financial and related planning and preparation our proposal to continue to assign CPT settlement of accountable care organizations (ACOs). This commenter codes included on the claim. The code 19298 to C–APC 5092 for CY 2018. commenters also stated that, previously, also recommended that CMS develop both breast brachytherapy catheter 3. Care Management Coding Changes documentation and billing workflow to placement codes 19296 (Breast Effective January 1, 2018 (APCs 5821 reduce administrative burden on interstitial radiation treatment, delayed and 5822) providers billing transitional care (expandable) and 19298 have been management and chronic care assigned to the same APC as they are As noted in the CY 2018 MPFS management codes. similar clinically and with regard to proposed rule (82 FR 34079), we Response: We appreciate the resource cost. The commenters continue to be interested in the ongoing commenters’ support. We also requested that CPT code 19298 be work of the medical community to appreciate the suggestion for reducing assigned to the same C–APC as CPT refine the set of codes used to describe provider burden with respect to billing code 19296 proposed for CY 2018; that care management services, including and documentation requirements for is, C–APC 5093 (Level 3 Breast/ chronic care management. In the CY chronic care management and will Lymphatic Surgery and Related 2018 OPPS/ASC proposed rule (82 FR consider these suggestions in future Procedures). 33603 and 33604), we proposed to adopt rulemaking. However, we note that Response: Our analysis of the final CPT replacement codes for CY 2018 for ACOs are outside the scope of this final rule updated claims data revealed a several of the care management services rule with comment period. geometric mean cost of approximately finalized last year and sought public After consideration of the public $5,944 for CPT code 19298 based on 68 comment on ways we might further comments we received, we are single claims (out of 69 total claims). reduce the burden on reporting finalizing our proposal to adopt CPT Based on our updated analysis, we providers, including through stronger replacement codes for CY 2018 for believe that CPT code 19298 is alignment between CMS requirements several of the care management services appropriately assigned to C–APC 5092, and CPT guidance for existing and finalized last year. Table 22 below which has a geometric mean cost of potential new codes. Table 15 of the CY details the final care management approximately $4,809, rather than to 2018 OPP/ASC proposed rule detailed coding changes. We refer readers to C–APC 5093, which has a geometric the proposed care management coding Addendum B to this final rule with mean cost of approximately $7,383 as changes. We referred readers to comment period (which is available via suggested by the commenters. In Addendum B to the proposed rule the Internet on the CMS Web site) for addition, our updated analysis showed (which is available via the Internet on the final CY 2018 payment rates for the that the geometric mean cost of the CMS Web site) for the proposed CY replacement codes.
TABLE 22—CARE MANAGEMENT CODING CHANGES EFFECTIVE JANUARY 1, 2018
CY 2018 CY 2018 CY 2017 CY 2017 HCPCS code CY 2017 CY 2017 replacement replacement HCPCS CY 2018 CY 2018 HCPCS code short descriptor OPPS SI OPPS ASC CPT code code short descriptor * OPPS SI OPPS APC
G0502 ...... Init psych care Manag, S 5822 99492 1st Psyc collab care S 5822 70min. mgmt. G0503 ...... Subseq psych care man, S 5822 99493 Sbsg psyc collab care S 5822 60mi. mgmt.
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TABLE 22—CARE MANAGEMENT CODING CHANGES EFFECTIVE JANUARY 1, 2018—Continued
CY 2018 CY 2018 CY 2017 CY 2017 HCPCS code CY 2017 CY 2017 replacement replacement HCPCS CY 2018 CY 2018 HCPCS code short descriptor OPPS SI OPPS ASC CPT code code short descriptor * OPPS SI OPPS APC
G0504 ...... Init/sub psych Care add N N/A 99494 1st/sbsq psyc collab care N N/A 30 m. G0505 ...... Cog/func assessment S 5822 99483 Assmt & care pln pt cog S 5822 outpt. imp. G0507 ...... Care manage serv min- S 5821 99484 Care mgmt. svc bhvl hlth S 5821 imum 20. cond. * The long descriptors for the final CPT codes can be found in Addendum O (New Category I and Category III CPT Codes Effective January 1, 2018) to this final rule with comment period, which is available via the Internet on the CMS Web site.
4. Cardiac Telemetry (APC 5721) 2018 OPPS/ASC proposed rule, we Procedures) to APC 5734 (Level 4 Minor For CY 2018, as noted in Table 23 proposed to reassign CPT code 93229 Procedures), with a proposed payment below and in Addendum B to the CY from APC 5733 (Level 3 Minor rate of $94.27.
TABLE 23—PROPOSED CY 2018 STATUS INDICATOR (SI), APC ASSIGNMENT, AND PAYMENT RATE FOR CPT CODE 93229
Proposed CY 2017 Proposed Proposed CY 2018 CPT Code Long descriptor CY 2017 CY 2017 OPPS CY 2018 CY 2018 OPPS OPPS SI OPPS APC payment OPPS SI OPPS APC payment rate rate
93229 ...... External mobile cardiovascular telem- S 5733 $54.55 S 5734 $94.27 etry with electrocardiographic re- cording, concurrent computerized real time data analysis and greater than 24 hours of accessible ecg data storage (retrievable with query) with ecg triggered and patient se- lected events transmitted to a re- mote attended surveillance center for up to 30 days; technical support for connection and patient instruc- tions for use, attended surveillance, analysis and transmission of daily and emergent data reports as pre- scribed by a physician or other qualified health care professional.
We proposed to revise the APC reassignment to APC 5722 (Level 2 The commenters further indicated that assignment for CPT code 93229 based Diagnostic Tests and Related Services), the service is not a minor procedure, as on claims data used for the CY 2018 which had a proposed payment rate of described by the group description for OPPS/ASC proposed rule. We note that $242.21 and which is the same APC APC 5734, and added that CPT code the proposed rule data were based on assignment for CPT code 93229 as in CY 93229 is the only code in APC 5734 claims data submitted between January 2016. The commenters believed that the with a status indicator assignment of 1, 2016, and December 31, 2016, that cost data used to set the payment rate ‘‘S’’ (Procedure or Service, Not were processed on or before December for the CY 2017 OPPS update was based Discounted When Multiple), while all 31, 2016. Our analysis of the claims data on miscoding of the service because the other codes in the APC are assigned revealed a geometric mean cost of mobile outpatient telemetry is a low- to status indicator ‘‘Q1’’ (conditionally approximately $156 for CPT code 93229 volume service in the HOPD setting that packaged). based on 1,518 single claims (out of is performed by a small number of Response: Although CPT code 93229 3,370 total claims). Our analysis further hospitals. The commenters indicated was assigned to status indicator ‘‘S’’ in revealed a geometric mean cost of that since the publication of a 2016 APC 5734, it was not the only status approximately $98 for APC 5734. Based coding guidance in the AHA Coding indicator assigned to the codes in this on the geometric mean cost, we believed Clinic for HCPCS on the proper coding APC. As indicated in OPPS Addendum that it was necessary to revise the APC of remote cardiac monitoring services, B that was released with the CY 2018 assignment for CPT code 93229 from they have noticed that the top billers of OPPS/ASC proposed rule, three separate APC 5733 to APC 5734 to pay this service from prior years are no status indicators were assigned to the appropriately for the service. longer inappropriately reporting the codes in APC 5734. Specifically, CPT Comment: Some commenters service. In addition, the commenters code 93229 was assigned to status disagreed with the proposed believed that APC 5734 is an indicator ‘‘S’’, CPT codes 30903 and reassignment of CPT code 93229 to APC inappropriate assignment both from the 30905 were assigned to status indicator 5734, and instead requested a clinical and resource cost perspectives. ‘‘T’’ (Procedure or Service, Discounted
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When Multiple), and the remaining For this CY 2018 OPPS/ASC final rule reassignment of CPT code 93229 to APC codes were assigned to status indicator with comment period, we again 5721 is more appropriate. ‘‘Q1’’. We note that a specific status reviewed the claims data associated In summary, after consideration of the indicator assignment does not preclude with CPT code 93229. We note that, for public comments we received, we are a code’s assignment to a specific APC. this final rule with comment period, we finalizing our CY 2018 proposal with In addition, as we have stated since used claims data with dates of service modification. Specifically, we are the implementation of the OPPS in between January 1, 2016, and December August 2000, section 1833(t)(9) of the 31, 2016 that were processed on or revising the assignment for CPT code Act requires that we annually review all before June 30, 2017. Our analysis 93229 to APC 5721 for CY 2018 rather the items and services within an APC revealed a geometric mean cost of than the proposed APC 5734. Consistent group and revise the APC structures approximately $160 for CPT code 93229 with our policy of reviewing APC accordingly. Included in this review is based on 1,750 single claims (out of assignments annually, we will the identification of any 2 times rule 3,869 total claims). Based on our review reevaluate the cost of CPT code 93229 violations as provided under section of the four levels of Diagnostic Tests and and its APC assignment for the CY 2019 1833(t)(2) of the Act and, to the extent Related Services APCs, we believe that rulemaking. Table 24 below lists the possible, rectification of these CPT code 93229 appropriately fits in final status indicator and APC violations. We review the most recently APC 5721 (Level 1 Diagnostic Tests and assignment for CPT code 93229 for CY available OPPS claims data every year Related Services), which has a 2018. We refer readers to Addendum B and determine whether changes to the geometric mean cost of approximately of this final rule with comment period current APC assignment are necessary. $136, rather than in APC 5722, which for the payment rates for all codes Although CPT code 93229 was assigned has a geometric mean cost of reported under the OPPS. In addition, to APC 5722 in CY 2016, we revised the approximately $249. In addition, our we refer readers to Addendum A to this APC assignment to APC 5733 for CY review shows that the geometric mean final rule with comment period for the 2017 based on the latest claims data cost of approximately $160 for CPT code status indicator meanings for all codes available at that time. The discussion 93229 is within the range of the reported under the OPPS. Both related to this APC revision can be significant procedures in APC 5721, Addenda A and B are available via the found in the CY 2017 OPPS/ASC final which is between $60 (for CPT code Internet on the CMS Web site. rule with comment period (81 FR 79616 93702) and $181 (for CPT code 94727). through 79617). Consequently, we believe that a
TABLE 24—FINAL CY 2018 STATUS INDICATOR (SI) AND APC ASSIGNMENT FOR CPT CODE 93229
CY 2017 CY 2017 CY 2017 OPPS CY 2018 CY 2018 CY 2018 OPPS CPT code Long descriptor OPPS SI OPPS APC payment OPPS SI OPPS APC payment rate rate
93229 ...... External mobile cardiovascular te- S 5733 $54.55 S 5721 Refer to OPPS lemetry with electrocardio- Addendum B. graphic recording, concurrent computerized real time data analysis and greater than 24 hours of accessible ecg data storage (retrievable with query) with ecg triggered and patient selected events transmitted to a remote attended surveillance center for up to 30 days; tech- nical support for connection and patient instructions for use, at- tended surveillance, analysis and transmission of daily and emergent data reports as pre- scribed by a physician or other qualified health care profes- sional.
5. Collagen Cross-Linking of Cornea (C– APC 5502 to APC 5504 (Level 4 to perform the procedure described by APC 5503) Extraocular, Repair, and Plastic Eye CPT code 0402T. According to the For CY 2018, as noted in Addendum Procedures). The commenter commenter, the capital equipment B to the CY 2018 OPPS/ASC proposed recommended reassignment to APC required for the procedure costs rule, we proposed to continue to assign 5504 because it believed that approximately $90,000, and disposable CPT code 0402T (Collagen cross-linking assignment to that APC would more supplies and at least one technician or of cornea (including removal of the accurately reflect the level of resource registered nurse are also required. In corneal epithelium and intraoperative utilization (particularly labor time and addition, the commenter stated that the pachymetry when performed)) to APC capital equipment) involved in the average procedure time can last from 5502 (Level 2 Extraocular, Repair, and corneal collagen cross-linking 1.25 to 2 hours. The commenter Plastic Eye Procedures) for CY 2018. procedure. In addition, the commenter acknowledged that there are no Comment: One commenter requested provided resource information on the Medicare claims data for CPT code that CMS reassign CPT code 0402T from supplies, equipment, and labor required
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0402T because it was established on account the disposable costs as well as replaced the code with CPT code 32994, January 1, 2016. information from the commenter about effective January 1, 2018. We note that Response: We reviewed the updated the time to perform the procedure and CPT code 0340T was effective January 1, CY 2016 claims data used for this final the hospital staff involved, we are 2014, and deleted on December 31, rule with comment period. Based on our persuaded to modify our proposal. 2017. Table 25 below lists the complete Given the resource cost and clinical review, and with consideration of the descriptors for the deleted and congruence of CPT code 0402T with resource information provided by the replacement code. We note that the other procedures assigned to APC 5503 commenter, in the absence of data and deleted and replacement code were both (approximate geometric mean cost of based on the resources and operating listed in Addendum B and Addendum $1,800), such as CPT code 65436 O to the CY 2018 OPPS/ASC proposed expenses to perform the procedure as (Removal of corneal epithelium; with described by the commenter, we rule (which are available via the Internet application of chelating agent, e.g., on the CMS Web site). Addendum B disagree with the commenter’s EDTA), we believe that the reassignment listed the proposed status indicator recommendation that CPT code 0402T to APC 5503 is more appropriate for CY assignment for the replacement code should be reassigned to APC 5504, 2018. Therefore, we are modifying our which has a geometric mean cost of proposal, and reassigning CPT code and assigned it to comment indicator approximately $3,000 in CY 2018. In the 0402T to APC 5503 (Level 3 Extraocular, ‘‘NP’’ (New code for the next calendar absence of claims data, we may use Repair, and Plastic Eye Procedures) for year or existing code with substantial other data, such as invoices, to assign a CY 2018. We will consider reassignment revision to its code descriptor in the new procedure to a clinical APC. In this of CPT code 0402T to APC 5504 in the next calendar year as compared to case, the commenter did not provide CY 2019 rulemaking. current calendar year, proposed APC invoices, but did supply some cost assignment; comments will be accepted information in its comment. We note 6. Cryoablation Procedure for Lung on the proposed APC assignment for the that the payment rate is not designed to Tumors (C–APC 5361) new code), while Addendum O listed pay for capital equipment costs on a per For CY 2018, the AMA CPT Editorial the proposed/placeholder CY 2018 CPT claim basis. However, taking into Panel deleted CPT code 0340T and codes and the long descriptors.
TABLE 25—CODING CHANGES FOR CPT CODE 32994
CY 2018 OPPS/ASC CPT Code proposed rule Long descriptor placeholder code
0340T ...... Ablation, pulmonary tumor(s), including pleura or chest wall when involved by tumor extension, percutaneous, cryoablation, unilateral, includes imaging guidance. 32994 ...... 32X99 ...... Ablation therapy for reduction or eradication of 1 or more pulmonary tumor(s) including pleura or chest wall when involved by tumor extension, percutaneous, including imaging guidance when performed, unilateral; cryoablation.
As noted in Table 26 below and in code 32994 (placeholder code 32X99), was assigned to C–APC 5361, which is Addendum B to the CY 2018 OPPS/ASC to C–APC 5361 (Level 1 Laparoscopy the same APC assignment for CPT code proposed rule, we proposed to delete and Related Services), with a proposed 32994. CPT code 0340T (status indicator ‘‘D’’) payment rate of $4,340.65. As noted in and assign its replacement code, CPT Table 26, for CY 2017, CPT code 0340T
TABLE 26—PROPOSED CY 2018 STATUS INDICATOR (SI), APC ASSIGNMENT, AND PAYMENT RATE FOR CPT CODE 32994
CY 2018 Proposed OPPS/ASC CY 2017 Proposed Proposed CY 2018 CPT code proposed rule Short descriptor CY 2017 CY 2017 OPPS CY 2018 CY 2018 OPPS placeholder OPPS SI OPPS APC payment OPPS SI OPPS APC payment code rate rate
0340T ...... Ablate pulm tumors J1 5361 $4,199.13 D N/A N/A + extnsn. 32994 ...... 32X99 ...... Ablate pulm tumor N/A N/A N/A J1 5361 $4,340.65 perq crybl.
Comment: Commenters presented APC and addresses resource cost which had a proposed payment rate of opposing recommendations on the fluctuation and volatility, and suggested $7,213.53. One commenter understood proposed APC assignment for CPT code that CMS finalize the proposal. why CMS proposed to assign CPT code 32994. Some commenters supported the However, other commenters disagreed 32994 to C–APC 5361, which is the proposed APC assignment to C–APC with the proposed APC assignment and same APC to which its predecessor code 5361. One commenter stated that the recommended that CPT code 32994 be was assigned. However, the commenter APC assignment maintains clinical assigned to C–APC 5362 (Level 2 believed that the cost of the procedure homogeneity for services within the Laparoscopy and Related Services), will only increase as hospitals gain
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experience with it. Consequently, the 5361 than to the geometric mean cost of analysis of the updated claims data for commenter suggested that CMS assign approximately $7,591 for C–APC 5362. this final rule with comment period, we the CPT code to C–APC 5362. Another We do not agree that we should assign are finalizing our CY 2018 proposal commenter recommended that CMS CPT code 32994 to C–APC 5362 because without modification, and assigning assign CPT code 32994 to C–APC 5362 the geometric mean cost for this APC is CPT code 32994 to C–APC 5361. The and further noted the importance of new significantly greater than that of CPT final CY 2018 geometric mean cost for codes to be priced correctly before they code 32994 (cross-walked from CPT C–APC 5361 is approximately $4,486. are subject to APC placement based on code 0340T) as indicated in our claims Table 27 below lists the final status their actual cost data. data available for this final rule with indicator and APC assignment for CPT Response: Because CPT code 0340T is comment period. In addition, if the cost code 32994 for CY 2018. We refer a predecessor code to CPT code 32994, of the procedure increases, this will be readers to Addendum B to this final rule we have historical claims data on which identified through our annual review of to base the payment rate for CPT code the claims data. Consistent with our with comment period for the payment 32994. Review of our claims data for policy of reviewing APC assignments rates for all codes reported under the this final rule with comment period annually, we will reevaluate the OPPS. In addition, we refer readers to shows a geometric mean cost of geometric mean cost of CPT code 32994 Addendum A to this final rule with approximately $5,471 for CPT code and its APC assignment in next year’s comment period for the status indicator 0340T based on 27 single claims (out of rulemaking for the CY 2019 OPPS meanings for all codes reported under 27 total claims), which is more update. the OPPS. Both Addenda A and B are comparable to the geometric mean cost In summary, after consideration of the available via the Internet on the CMS of approximately $4,486 for C–APC public comments we received and our Web site.
TABLE 27—FINAL CY 2018 STATUS INDICATOR (SI) AND APC ASSIGNMENT FOR CPT CODE 32994
CY 2018 OPPS/ASC CY 2017 CPT code proposed rule Short descriptor CY 2017 CY 2017 OPPS CY 2018 CY 2018 CY 2018 OPPS placeholder OPPS SI OPPS APC payment OPPS SI OPPS APC payment rate code rate
0340T ...... N/A ...... Ablate pulm tu- J1 5361 $4,199.13 D N/A N/A. mors + extnsn. 32994 ...... 32X99 ...... Ablate pulm N/A N/A N/A J1 5361 Refer to OPPS tumor perq Addendum B. crybl.
7. Diagnostic Bone Marrow Aspiration will be deleted on December 31, 2017 existing code with substantial revision and Biopsy (C–APC 5072) and replaced with CPT codes 38220, to its code descriptor in the next For CY 2018, the AMA CPT Editorial 38221, and 38222, effective January 1, calendar year as compared to current Panel revised the bone marrow and 2018. The deleted and replacement calendar year, proposed APC aspiration CPT codes. Specifically, the codes were listed in Addendum B and assignment; comments will be accepted descriptors for CPT codes 38220 and Addendum O to the CY 2018 OPPS/ASC on the proposed APC assignment for the 38221 were revised and new CPT codes proposed rule. Addendum B listed the new code), while Addendum O listed 20939 (placeholder code 2093X) and proposed status indicator assignment for the proposed/placeholder CY 2018 CPT 38222 (placeholder code 382X3) were revised CPT codes 38220 and 38221 and codes and the long descriptors. established, effective January 1, 2018. In new CPT code 38222, which was Table 28 below lists the complete addition, add-on HCPCS code G0364, assigned to comment indicator ‘‘NP’’ descriptors for the bone marrow which was effective January 1, 2005, (New code for the next calendar year or aspiration and biopsy codes.
TABLE 28—CODING CHANGES FOR THE BONE MARROW ASPIRATION AND BIOPSY CODES
CY 2018 OPPS/ASC HCPCS code proposed rule Long descriptor placeholder code
20939 ...... 2093X ...... Bone marrow aspiration for bone grafting, spine surgery only, through separate skin or fascial incision (List separately in addition to code for primary procedure). 38220 ...... N/A ...... Diagnostic bone marrow; aspiration. 38221 ...... N/A ...... Diagnostic bone marrow; biopsy(ies). 38222 ...... 382X3 ...... Diagnostic bone marrow; biopsy(ies) and aspiration(s). G0364 ...... N/A ...... Bone marrow aspiration performed with bone marrow biopsy through the same incision on the same date of service.
As noted in Table 29 below and in ‘‘D’’) and assign revised CPT codes Incision and Drainage), with a proposed Addendum B of the CY 2018 OPPS/ASC 38220 and 38221, as well as new CPT payment rate of $1,268.53. We note that, proposed rule, we proposed to delete code 38222 (placeholder code 382X3) to under the OPPS, we packaged the HCPCS code G0364 (status indicator C–APC 5072 (Level 2 Excision/Biopsy/ payment for HCPCS code G0364 (status
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indicator ‘‘N’’) into the primary service proposed to assign CPT code 20939 on codes are packaged under the OPPS. or procedure that is reported with the (placeholder 2093X) to status indicator Further, we proposed to continue to code because we considered the service ‘‘N’’ (Packaged status) because it is an assign revised CPT codes 38220 and to be an add-on furnished as part of a add-on code. Under Medicare 38221 to C–APC 5072 for CY 2018. comprehensive service. In addition, we regulations at 42 CFR 419.2(b)(18), add- TABLE 29—PROPOSED CY 2018 STATUS INDICATOR (SI), APC ASSIGNMENT, AND PAYMENT RATES FOR THE BONE MARROW ASPIRATION AND BIOPSY CODES
CY 2018 Proposed OPPS/ASC CY 2017 CY 2017 Proposed Proposed CY 2018 HCPCS Code proposed rule Short descriptor CY 2017 OPPS OPPS CY 2018 CY 2018 OPPS placeholder OPPS SI APC payment OPPS SI OPPS payment code rate APC rate
20939 ...... 2093X ...... Bone marrow aspir bone grfg ...... N/A N/A N/A N N/A N/A 38220 ...... N/A ...... Dx bone marrow aspirations ...... J1 5072 $1,236.62 J1 5072 $1,268.53 38221 ...... N/A ...... Dx bone marrow biopsies ...... J1 5072 1,236.62 J1 5072 1,268.53 38222 ...... 382X3 ...... Dx bone marrow bx & aspir ...... N/A N/A N/A J1 5072 1,268.53 G0364 ...... N/A ...... Bone marrow aspirate &biopsy ...... N N/A N/A D N/A N/A
Comment: One commenter disagreed cost of approximately $1,319 for C–APC APC 5072 is the most appropriate APC with the proposed APC assignment of 5072. Consequently, we proposed to assignment for new CPT code 38222, new CPT code 38222 to C–APC 5072 maintain both codes in C–APC 5072 for consistent with the APC assignment for and recommended that the code be CY 2018. We note that we had no claims similar diagnostic bone marrow assigned to C–APC 5073 (Level 3 data for HCPCS code G0364 because this aspiration and biopsy procedures. As Excision/Biopsy/Incision and Drainage), is an add-on code whose payment is noted in Table 29, CPT codes 38220 and which had a proposed payment rate of packaged into the primary service that 38221 are assigned to C–APC 5072, and $2,222.47. This commenter further is reported with the code. we believe that the service described by noted the importance of new codes For this final rule with comment new CPT code 38222 is similar to the being priced correctly before they are period, we again analyzed updated existing bone marrow aspiration and subject to APC assignment based on claims data associated with the four biopsy codes. Consistent with the their actual cost data. codes. We note that, for this final rule statutory requirement under section Response: As displayed in Table 29, with comment period, we used claims 1833(t)(9)(A) of the Act, we will we proposed to make no change to the data with dates of service between reevaluate the APC groupings during the APC assignments for CPT codes 38220 January 1, 2016, and December 31, 2016, next rulemaking cycle. and 38221. Specifically, we proposed to that were processed on or before June continue to assign both codes to C–APC 30, 2017. Our review of the final rule After consideration of the public 5072 for CY 2018 based on claims data claims data revealed a similar pattern comment we received, we are finalizing used for the CY 2018 OPPS/ASC for both codes. For CPT code 38220, we our CY 2018 proposals, without proposed rule. We note that the found a geometric mean cost of modification, for the bone marrow proposed rule data was based on claims approximately $1,787 based on 5,908 aspiration and biopsy codes, data submitted between January 1, 2016, single claims (out of 5,993 total claims), specifically, CPT codes 20939, 38220, and December 31, 2016, that were and for CPT code 38221, our claims data 38221, and 38222. Table 30 below lists processed on or before December 31, revealed a geometric mean cost of the final APC and status indicator 2016. For CPT code 38220, our approximately $1,799 based on 59,892 assignments for CPT codes 20939, examination of the claims data revealed single claims (out of 60,467 total 38220, 38221, and 38222 for CY 2018. a geometric mean cost of approximately claims). Because the geometric mean We refer readers to Addendum B to this $1,645 based on 5,361 single claims (out costs of approximately $1,787 for CPT final rule with comment period for the of 5,431 total claims). For CPT code code 38220 and $1,799 for CPT code payment rates for all codes reported 38221, our claims data showed a 38221 are similar to the geometric mean under the OPPS. In addition, we refer geometric mean cost of approximately cost of approximately $1,347 for C–APC readers to Addendum A to this final $1,615 based on 53,789 single claims 5072, we continue to believe that rule with comment period for the status (out of 54,335 total claims). We believe C–APC 5072 is the most appropriate indicator meanings for all codes that the geometric mean costs of APC assignment for both codes for CY reported under the OPPS. Both approximately $1,645 for CPT code 2018. Addendum A and Addendum B are 38220 and $1,615 for CPT code 38221 In addition, based on input from our available via the Internet on the CMS are comparable to the geometric mean medical advisors, we believe that C– Web site. TABLE 30—FINAL CY 2018 STATUS INDICATOR (SI) AND APC ASSIGNMENT FOR THE BONE MARROW ASPIRATION AND BIOPSY CODES
CY 2018 CY 2017 CY 2018 OPPS/ASC CY 2017 CY 2017 OPPS CY 2018 CY 2018 OPPS HCPCS code proposed rule Short descriptor OPPS OPPS placeholder OPPS SI APC payment OPPS SI APC payment code rate rate
20939 ...... 2093X ...... Bone marrow aspir bone N/A N/A N/A N N/A N/A. grfg. 38220 ...... N/A ...... Dx bone marrow aspirations J1 5072 $1,236.62 J1 5072 Refer to OPPS Addendum B.
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TABLE 30—FINAL CY 2018 STATUS INDICATOR (SI) AND APC ASSIGNMENT FOR THE BONE MARROW ASPIRATION AND BIOPSY CODES—Continued
CY 2018 OPPS/ASC CY 2017 CY 2017 CY 2018 CY 2018 HCPCS code proposed rule Short descriptor CY 2017 OPPS OPPS CY 2018 OPPS OPPS placeholder OPPS SI APC payment OPPS SI APC payment code rate rate
38221 ...... N/A ...... Dx bone marrow biopsies .... J1 5072 1,236.62 J1 5072 Refer to OPPS Addendum B. 38222 ...... 382X3 ...... Dx bone marrow bx & aspir N/A N/A N/A J1 5072 Refer to OPPS Addendum B. G0364 ...... Bone marrow aspirate N N/A N/A D N/A N/A. &biopsy.
8. Discussion of Comment Solicitation expansion device, suture support for procedures does not warrant in the Proposed Rule on Intraocular intraocular lens, or primary posterior reassignment of CPT code 66982 into a Procedure APCs capsulorrhexis),’’ we stated that we higher payment APC. However, believe it may be more appropriate to commenters supported CMS’ intent to As discussed in the CY 2018 OPPS/ assign CPT code 66982 to a C–APC that monitor the data for these procedures ASC proposed rule (82 FR 33609 is separate from the C–APC assignment and make future changes, if needed. In through 33610), as part of our CY 2018 for CPT code 66984. However, because addition, one commenter indicated that comprehensive review of the structure this potential APC grouping would variations in payment between simple of the APCs and procedure code assign CPT code 66982 to a higher and complex cataract surgery should be assignments, we evaluated the paying C–APC than CPT code 66984, we reflected in the physician payment intraocular procedure APCs with a indicated that we would monitor claims rather than the facility fee. particular focus on C–APC 5491 (Level data for changes in the distribution of 1 Intraocular Procedures) that contains Response: We thank the commenters coding complex cataract surgery and for providing detailed responses to the cataract surgery procedures. We strive to routine cataract surgery if we were to maintain APCs that contain procedures comment solicitation on whether to adopt this change. In the proposed rule, separate simple and complex cataract that are relatively homogenous in we sought public comments from resource costs and clinical surgery into separate APCs. Based on stakeholders, including the points raised in response to the characteristics. While it is impracticable ophthalmologists, organizations and contrary to the principles of a comment solicitation with respect to the representing ophthalmologists, facility resource costs and clinical prospective payment system to assign beneficiaries, hospitals, and all other each procedure to its own APC, thus similarity between simple and complex interested parties on whether we should cataract surgery, it does not appear resulting in a cost-based, fee schedule create a new C–APC that includes payment system, we seek to ensure our necessary to separate these procedures complex cataract surgeries identified by into separate APCs. clinical groupings appropriately group CPT code 66982 (along with other like items and services while intraocular procedures that are similar After consideration of the public maintaining the integrity of a in resources) in a newly created C–APC comments we received, we are prospective payment system under that is separate from those identified by continuing the assignment of simple which bundled, encounter-based CPT code 66984. That is, we are and complex cataract surgery payments are essential. considering whether to establish a new procedures (described by CPT codes For CY 2018, we considered Level 2 Intraocular Procedures C–APC 66984 and 66982, respectively) to the proposing a new intraocular procedure in between existing C–APCs 5491 and same APC for CY 2018. We appreciate APC that would further distinguish the 5492. the commenters’ support of CMS’ resource costs and clinical Comment: Commenters, including continuing efforts to monitor both the characteristics between cataract surgery several ophthalmologists and cost and utilization of simple and and complex cataract surgery. As listed organizations representing complex cataract surgery to determine if in Addendum B of the CY 2018 OPPS/ ophthalmologists, did not support an APC reassignment or other change ASC proposed rule, we proposed to separation of complex cataract surgery may be needed in the future. continue to assign CPT code 66984 identified by CPT code 66982 and 9. Endovascular APCs (C–APCs 5191 (Cataract surgery with IOL 1 stage simple cataract surgery identified by through 5194) procedure) and CPT code 66982 CPT code 66984 into separate APCs. (Cataract surgery complex) to C–APC Commenters recommended that CMS For CY 2018, we proposed to continue 5491. However, because the 2017 AMA maintain the current assignment of CPT the existing four levels of Endovascular CPT Code manual describes a complex code 66982 and 66984 in the same APC C–APCs (C–APCs 5191 through 5194) as cataract surgery case as ‘‘requiring (APC 5491) because the procedures are displayed in Table 31 below and in devices or techniques not generally used similar clinically and the modest Addendum B to the CY 2018 OPPS/ASC in routine cataract surgery (e.g., iris variation in cost between the two proposed rule.
TABLE 31—PROPOSED CY 2018 GEOMETRIC MEAN COST AND PAYMENT FOR ENDOVASCULAR C–APCS
Proposed CY 2018 CY 2018 C–APC geometric OPPS mean cost payment
5191—Level 1 Endovascular Procedures ...... $2,958.89 $2,844
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TABLE 31—PROPOSED CY 2018 GEOMETRIC MEAN COST AND PAYMENT FOR ENDOVASCULAR C–APCS—Continued
Proposed CY 2018 CY 2018 C–APC geometric OPPS mean cost payment
5192—Level 2 Endovascular Procedures ...... 5,199.87 4,999 5193—Level 3 Endovascular Procedures ...... 10,627.86 10,218 5194—Level 4 Endovascular Procedures ...... 16,197.55 15,572
Comment: Commenters disagreed C–APC 5192 (Level 2 Endovascular C–APC 5193 be moved up one level to with the proposal to continue the four Procedures) to a new Level 3 a new Level 5 Endovascular Procedures levels of the endovascular C–APCs and Endovascular Procedures C–APC C–APC (519Y), and those procedures requested that CMS create more levels (519X), and reassigning procedures with with costs greater than approximately within the endovascular C–APCs to costs less than approximately $9,000 $13,000 to be moved down one level improve resource homogeneity within down one level, from the current C–APC from current C–APC 5194 (Level 4 these C–APCs. Specifically, the 5193 (Level 3 Endovascular Procedures) Endovascular Procedures) to the new commenters requested that CMS create to the new requested Level 3 requested Level 5 C–APC (519Y). The a six-level endovascular C–APC family Endovascular Procedures C–APC. commenters’ requested the C–APC by reassigning endovascular procedures Commenters also requested that structure and estimated payment with costs greater than approximately procedures with costs greater than amount for each C–APC as listed in $7,000 up one level, from the current approximately $12,000 in the current Table 32 below.
TABLE 32—CY 2018 STRUCTURE FOR ENDOVASCULAR C–APCS REQUESTED BY COMMENTERS
Estimated CY 2018 C–APC OPPS payment
5191—Level 1 Endovascular Procedures ...... $2,845 5192—Level 2 Endovascular Procedures ...... 4,875 519X—New Level 3 Endovascular Procedures ...... 8,042 5193—Current Level 3 Endovascular Procedures/New Level 4 Endovascular Procedures ...... 10,084 519Y—New Level 5 Endovascular Procedures ...... 12,149 5194—Current Level 4 Endovascular Procedures/New Level 6 Endovascular Procedures ...... 15,713
At the annual meeting for the HOP encouraged CMS to consider the impact homogeneity. We will continue to Panel held on August 21, 2017, the HOP that adding APCs for the endovascular review this C–APC structure, including Panel recommended that, for CY 2018, procedures may have on other consultation with the appropriate HOP CMS examine the number of APCs for procedures in existing APCs and Panel subcommittee, to determine if endovascular procedures. The HOP recommended that, if CMS plans to additional granularity is necessary for Panel also recommended that the make a change to the endovascular this C–APC family. appropriate Panel subcommittee review APCs, it include a proposal in the CY the APCs for endovascular procedures 2019 OPPS/ASC proposed rule to allow 10. Esophagogastroduodenoscopy (EGD) to determine whether more granularity the opportunity for the public to (C–APC 5362) (that is, more APCs) is warranted. comment. Other commenters opposed a Response: We thank the commenters For CY 2018, as displayed in Table 33 reorganization of the endovascular for their input. At this time, we below and in Addendum B to the CY C–APCs for CY 2018 and expressed continue to believe that the current 2018 OPPS/ASC proposed rule, we concerns regarding changing the C–APC levels for the endovascular proposed to continue to assign CPT number of C–APCs in this family C–APC family provide an appropriate code 43210 to APC 5331 (Complex GI without a chance for the public to distinction between the resource costs at Procedures), with a proposed payment comment. These commenters each level and provide clinical rate of $4,119.27.
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TABLE 33—PROPOSED CY 2018 STATUS INDICATOR (SI), APC ASSIGNMENT, AND PAYMENT RATE FOR CPT CODE 43210
Proposed CY 2017 CY 2017 CY 2017 Proposed Proposed CY 2018 CPT code Long descriptor OPPS OPPS OPPS CY 2018 CY 2018 OPPS SI APC payment OPPS OPPS payment rate SI APC rate
43210 ...... Esophagogastroduo-denoscopy, flexi- J1 5331 $3,940.61 J1 5331 $4,119.27 ble, transoral; with esophagogastric fundoplasty, partial or complete, in- cludes duodenoscopy when per- formed.
Comment: One commenter disagreed energy to the muscle of lower of service between January 1, 2016, and with the proposed APC assignment for esophageal sphincter and/or gastric December 31, 2016, that were processed CPT code 43210 and stated that that the cardia, for treatment of gastroesophageal on or before June 30, 2017. Our analysis proposed payment is inadequate to reflux disease); of the final rule claims data revealed a cover the cost of the procedure. The • 43280 (Laparoscopy, surgical, geometric mean cost of approximately commenter stated that the device esophagogastric fundoplasty (e.g., $6,759 for CPT code 43210 based on 91 associated with the procedure costs nissen, toupet procedures)); single claims (out of 92 total claims), approximately $4,100. The commenter • 43281 (Laparoscopy, surgical, repair which is comparable to the geometric elaborated that because of the of paraesophageal hernia, includes mean cost of approximately $7,591 for inadequate payment for the procedure, fundoplasty, when performed; without C–APC 5362. Compared to the implantation of mesh); providers are reluctant to perform the • geometric mean cost of approximately procedure, and instead are opting to 43284 (Laparoscopy, surgical, $4,291 for C–APC 5331, we agree with perform the higher paying procedures esophageal sphincter augmentation the commenter that C–APC 5362 is the for the treatment of gastroesophageal procedure, placement of sphincter more appropriate C–APC assignment for reflux disease (GERD). The commenter augmentation device (i.e., magnetic CPT code 43210 based on its clinical also stated that, based on the geometric band), including cruroplasty when homogeneity and resource costs. mean cost of $7,013 for CPT code 43210, performed); • 43770 (Laparoscopy, surgical, In summary, after consideration of the the code is inappropriately assigned to gastric restrictive procedure; placement public comment we received, we are APC 5331, which has a geometric mean of adjustable gastric restrictive device finalizing our CY 2018 proposal with cost of approximately $4,284. To correct (e.g., gastric band and subcutaneous modification. Specifically, we are the inadequate payment for the port components)); and reassigning CPT code 43210 from procedure, the commenter suggested • 46762 (Sphincteroplasty, anal, for C–APC 5331 to C–APC 5362 for CY that CMS either reassign CPT code incontinence, adult; implantation 2018. As we do every year under the 43210 to C–APC 5362 (Level 2 artificial sphincter). OPPS, we will reevaluate the cost of the Laparoscopy and Related Services), Response: For the second suggestion, procedure and its APC assignment for which had a proposed payment rate of we believe the grouping of procedures next year’s OPPS rulemaking. Table 34 $7,214, or establish a new Level 2 in the suggested APC may be below lists the final status indicator and Complex GI Procedures APC that inappropriate based on lack of clinical APC assignments for CPT code 43210. contains only the surgical procedures homogeneity. Specifically, CPT code We refer readers to Addendum B of this described by the following CPT codes: 46762 describes a sphincteroplasty final rule with comment period for the • 43210 procedure, which is unlike that of the payment rates for all codes reported (Esophagogastroduodenoscopy, flexible, other GERD-related procedures in the under the OPPS. In addition, we refer transoral; with esophagogastric suggested APC. However, for the first readers to Addendum A of this final fundoplasty, partial or complete, suggestion, based on our analysis of the rule with comment period for the status includes duodenoscopy when final rule claims data, we believe that it indicator meanings for all codes performed); would be appropriate to reassign CPT reported under the OPPS. Both • 43257 code 43210 to C–APC 5362. We note Addendum A and Addendum B are (Esophagogastroduodenoscopy, flexible, that, for this final rule with comment available via the Internet on the CMS transoral; with delivery of thermal period, we used claims data with dates Web site.
TABLE 34—FINAL CY 2018 STATUS INDICATOR (SI) AND APC ASSIGNMENT FOR CPT CODE 43210
CY 2017 CY 2017 CY 2017 OPPS CY 2018 CY 2018 CY 2018 OPPS CPT code Long descriptor OPPS OPPS payment OPPS OPPS payment rate SI APC rate SI APC
43210 ...... Esophagogastroduo-denoscopy, J1 5331 $3,940.61 J1 5362 Refer to OPPS flexible, transoral; with Addendum B. esophagogastric fundoplasty, partial or complete, includes du- odenoscopy when performed.
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11. Hemorrhoid Treatment by Thermal 2018 OPPS/ASC proposed rule, we GI Procedures), with a proposed Energy (APC 5312) proposed to continue to assign CPT payment rate of $690.37. For CY 2018, as displayed in Table 35 code 46930 to APC 5311 (Level 1 Lower below and in Addendum B to the CY
TABLE 35—PROPOSED CY 2018 STATUS INDICATOR (SI), APC ASSIGNMENT, AND PAYMENT RATE FOR CPT CODE 46930
Proposed CY 2017 CY 2017 CY 2017 Proposed Proposed CY 2018 HCPCS code Long descriptor OPPS OPPS OPPS CY 2018 CY 2018 OPPS SI APC payment OPPS OPPS payment rate SI APC rate
46930 ...... Destruction of internal T 5311 $667.67 T 5311 $690.37 hemorrhoid(s) by ther- mal energy (e.g., infra- red coagulation, cau- tery, radiofrequency).
Comment: One commenter requested Our analysis of the final rule claims data code 45341) and $1,579 (for CPT 45390). a reassignment of CPT code 46930 to revealed that a change in the APC Consequently, we agree that a APC 5312 (Level 2 Lower GI assignment to APC 5312 for CPT code reassignment of CPT code 46930 to APC Procedures), which had a CY 2018 46930 is appropriate. Specifically, we 5312 is more appropriate. proposed payment rate of $907.04. The found a geometric mean cost of Therefore, after consideration of the commenter indicated that review of the approximately $858 for CPT code 46930 public comment we received, we are geometric mean cost of approximately based on 363 single claims (out of 970 finalizing our CY 2018 proposal with $879 for CPT code 46930 from the CY total claims), which is similar to the 2018 proposed rule claims data is more geometric mean cost of approximately modification to the APC assignment for in line with the geometric mean cost for $936 for APC 5312 rather than the CPT code 46930. Specifically, we are APC 5312. Specifically, the commenter geometric mean cost of approximately reassigning CPT code 46930 from C– noted that the geometric mean cost for $710 for APC 5311. In addition, our APC 5311 to C–APC 5312 for CY 2018. APC 5312 is approximately $943, which analysis of the range of geometric mean Table 36 below lists the final status is comparable to the geometric cost of costs for the significant procedures indicator and APC assignments for CPT $879 for CPT code 46930, rather than within APCs 5311 and 5312 shows that code 49630. We refer readers to the geometric mean cost of the geometric mean cost for CPT code Addendum B to this final rule with approximately $718 for APC 5311. 46930 is comparable to the costs of comment period for the payment rates Response: For this final rule with procedures assigned to APC 5312. for all codes reported under the OPPS. comment period, we reviewed the Specifically, the geometric mean costs In addition, we refer readers to claims data associated with CPT codes of the significant procedures assigned to Addendum A to this final rule with 46930. We used claims data for this APC 5311 range between approximately comment period for the status indicator final rule with comment period with $382 (for CPT code 46221) and $750 (for meanings for all codes reported under dates of service between January 1, CPT code 45378), while the range for the OPPS. Both Addendum A and 2016, and December 31, 2016 that were procedures assigned to APC 5312 is Addendum B are available via the processed on or before June 30, 2017. between approximately $824 (for CPT Internet on the CMS Web site.
TABLE 36—FINAL CY 2018 STATUS INDICATOR (SI) AND APC ASSIGNMENT FOR CPT CODE 46930
CY 2017 CY 2017 CY 2017 OPPS CY 2018 CY 2018 CY 2018 CPT code Long descriptor OPPS OPPS payment OPPS OPPS OPPS payment SI APC rate SI APC rate
46930 ...... Destruction of internal hemor- T 5311 $667.67 T 5312 Refer to OPPS rhoid(s) by thermal energy (e.g., Addendum B. infrared coagulation, cautery, radiofrequency).
12. Ileoscopy Through Stoma With Stent 2018 OPPS/ASC proposed rule, we Placement (C–APC 5303) proposed to continue to assign CPT For CY 2018, as displayed in Table 37 code 44384 to C–APC 5303 (Level 3 below and in Addendum B to the CY Upper GI Procedures).
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TABLE 37—PROPOSED CY 2018 STATUS INDICATOR (SI), APC ASSIGNMENT, AND PAYMENT RATE FOR CPT CODE 44384
Proposed CY 2017 Proposed Proposed CY 2018 CPT code Long descriptor CY 2017 CY 2017 OPPS CY 2018 CY 2018 OPPS OPPS SI OPPS APC payment OPPS SI OPPS APC payment rate rate
44384 ...... Ileoscopy, through stoma; with place- J1 5303 $2,510.70 J1 5303 $2,630.93 ment of endoscopic stent (includes pre- and post-dilation and guide wire passage, when performed).
Comment: Several commenters For this final rule with comment refer readers to section IV.B. of this final opposed the proposed continued period, we again examined updated rule with comment period for the assignment of CPT code 44384 to claims data associated with CPT code discussion related to the device- C–APC 5303. The commenters stated 44384. We note that for this final rule intensive policy under the OPPS. For a that the procedure includes the use of with comment period we used claims discussion of ASC procedures a stent that costs approximately $1,500, data with dates of service between designated as device-intensive, we refer and that the resources required to January 1, 2016, and December 31, 2016, readers to section XII.C.1.c. of this final perform the procedure are similar to that were processed on or before June rule with comment period. those other small and large bowel 30, 2017. Our examination of the final Finally, we remind readers that, as we procedures that require stent placement rule claims data revealed a similar have stated since the implementation of in C–APC 5331 (Complex GI pattern for CPT code 44384. the OPPS in August 2000, section Procedures), which had a CY 2018 Specifically, we found a geometric mean 1833(t)(9) of the Act requires that we proposed payment rate of $4,119.27. cost of approximately $2,492 for CPT annually review all the items and The commenters further added that code 44384 based on 32 single claims services within an APC group and revise because C–APC 5303 is not a device- (out of 33 total claims), which is similar the APC structures accordingly. dependent designated APC, the to the geometric mean cost of Included in this review is the continued assignment of CPT code approximately $2,742 for C–APC 5303 identification of any 2 times rule 44384 to C–APC 5303 results in an ASC rather than the geometric mean cost of violations as provided under section payment that is below the cost of approximately $4,291 for C–APC 5331. 1833(t)(2) of the Act and, to the extent Assigning CPT code 43384 to C–APC performing the procedure. possible, rectification of these 5331 would result in an overpayment Consequently, the commenters urged violations. We review our claims data for the procedure. C–APC 5303 contains CMS to revise the APC assignment for every year and determine whether we several GI-related procedures, which are CPT code 44384 back to its CY 2016 need to make changes to the current similar to those procedures described by APC assignment, specifically, C–APC APC assignment for the following year. CPT code 44384, based on clinical 5331. Although CPT code 44384 was assigned homogeneity and resource costs. Response: We proposed to continue In response to the comment related to to C–APC 5331 in CY 2016, we revised the APC assignment for CPT code 44384 device-dependent APCs, we note that the assignment to C–APC 5303 for CY based on claims data used for the CY device-dependent APCs are no longer 2017 based on the latest claims data. 2018 OPPS/ASC proposed rule. We note recognized under the OPPS as of CY In summary, after consideration of the that the proposed rule data was based 2015 and that, effective January 1, 2017, public comments we received, we are on claims data submitted between device-intensive status is assigned at the finalizing our CY 2018 proposal without January 1, 2016, and December 31, 2016, HCPCS code level, not at the APC level. modification to continue the assignment that were processed on or before We note that when we implemented the of CPT code 44384 to C–APC 5303. December 31, 2016. For CPT code C–APC policy in CY 2015, we Table 38 below lists the final status 44384, our analysis of the claims data eliminated the device-dependent APC indicator and APC assignments for CY revealed a geometric mean cost of policy and replaced it with the device- 2018. We refer readers to Addendum B approximately $2,404 for the CPT code intensive policy, effective January 1, to this final rule with comment period based on 25 single claims (out of 26 2015. For more information on this for the payment rates for all codes total claims), which is similar to the change, we refer readers to the CY 2015 reported under the OPPS. In addition, geometric mean cost of approximately OPPS/ASC final rule with comment we refer readers to Addendum A to this $2,736 for C–APC 5303 rather than the period (79 FR 66793 through 66795), the final rule with comment period for the geometric mean cost of approximately CY 2016 OPPS/ASC final rule with status indicator meanings for all codes $4,284 for C–APC 5331. Consequently, comment period (80 FR 70421 through reported under the OPPS. Both we proposed to continue the APC 70422), and the CY 2017 OPPS/ASC Addendum A and Addendum B are assignment for CPT code 44384 to final rule with comment period (81 FR available via the Internet on the CMS C–APC 5303 for CY 2018. 79657 through 79659). In addition, we Web site.
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TABLE 38—FINAL CY 2018 STATUS INDICATOR (SI) AND APC ASSIGNMENT FOR CPT CODE 44384
CY 2017 CY 2017 CY 2017 OPPS CY 2018 CY 2018 CY 2018 OPPS CPT code Long descriptors OPPS SI OPPS APC payment OPPS SI OPPS APC payment rate rate
44384 ...... Ileoscopy, through stoma; with J1 5303 $2,510.70 J1 5303 Refer to OPPS placement of endoscopic stent Addendum B. (includes pre- and post-dilation and guide wire passage, when performed).
13. Laparoscopic Nephrectomy (C–APC 2018 OPPS/ASC proposed rule, we payment rate of $15,220.83 to C–APC 5362) proposed to reassign CPT code 50543 5362 (Level 2 Laparoscopy and Related For CY 2018, as displayed in Table 39 from C–APC 5377 (Level 7 Urology and Services), which had a proposed below and in Addendum B to the CY Related Services), which had a proposed payment rate of $7,213.53.
TABLE 39—PROPOSED CY 2018 STATUS INDICATOR (SI), APC ASSIGNMENT, AND PAYMENT RATE FOR CPT CODE 50543
Proposed CY 2017 CY 2017 CY 2017 Proposed Proposed CY 2018 CPT code Long descriptor OPPS SI OPPS APC OPPS CY 2018 CY 2018 OPPS payment OPPS SI OPPS APC payment
50543 ...... Laparoscopy, surgical; partial ne- J1 5377 $14,363.61 J1 5362 $7,213.53 phrectomy.
Comment: One commenter applauded CPT code based on its clinical Therefore, after consideration of the CMS’ proposal to remove CPT code coherence and resource similarity to the public comment we received, we are 50543 from C–APC 5377. The other procedures in the APC. Although finalizing our proposal, without commenter indicated that the code was our analysis showed a geometric mean modification, to reassign CPT code inappropriately placed in C–APC 5377 cost of approximately $7,591 for C–APC 50543 to C–APC 5362 for CY 2018. As because the procedure involves no 5362, which is lower than the geometric we do every year, we will review our implantable device, which is in contrast mean cost of approximately $10,247 for claims data for the procedure for the CY to the device-related procedures in C– CPT code 50543 based on 1,008 single 2019 OPPS rulemaking. Table 40 below APC 5377. The commenter believed that claims (out of 1,016 total claims), we lists the final CY 2018 status indicator found that the geometric mean cost for the addition of this CPT code to C–APC and APC assignments for CPT code 5377 for CY 2017 was an error that the CPT code falls within the range of 50543. We refer readers to Addendum B disrupted the clinical homogeneity of costs for significant procedures assigned to this final rule with comment period the APC. The commenter suggested that to C–APC 5362. Specifically, the cost for the payment rates for all codes CMS finalize the proposal to reassign range for procedures assigned to C–APC CPT code 50543 from C–APC 5377 to 5362 is between approximately $5,997 reported under the OPPS. In addition, APC 5362. (for CPT code 50593) and $10,247 (for we refer readers to Addendum A to this Response: We appreciate the CPT code 50543). Based on the final final rule with comment period for the commenter’s support. For this final rule rule claims data, we believe that CPT status indicator meanings for all codes with comment period, we again code 50543 is more appropriately reported under the OPPS. Both reviewed the updated claims data assigned to C–APC 5362 based on its Addendum A and Addendum B are associated with CPT code 50543 and clinical coherence and resource available via the Internet on the CMS continue to believe that C–APC 5362 is similarity to the other procedures Web site. the more appropriate assignment for the assigned to C–APC 5362.
TABLE 40—FINAL CY 2018 STATUS INDICATOR (SI) AND APC ASSIGNMENT FOR CPT CODE 50543
CY 2017 CY 2017 CY 2017 OPPS CY 2018 CY 2018 CY 2018 CPT code Long descriptor OPPS SI OPPS APC payment OPPS SI OPPS APC OPPS rate payment rate
50543 ...... Laparoscopy, surgical; partial ne- J1 5377 $14,363.61 J1 5362 Refer to OPPS phrectomy. Addendum B.
14. Multianalyte Assays With the CY 2018 OPPS/ASC proposed rule, ‘‘Q4’’ to indicate that the codes are Algorithmic Analyses (MAAA) we proposed to continue to assign CPT conditionally packaged. Specifically, as codes 81490, 81503, 81535, 81536, defined in Addendum D1 to the CY For CY 2018, as displayed in Table 41 81538, and 81539, to status indicator 2018 OPPS/ASC proposed rule, an below and as listed in Addendum B to
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assignment to status indicator ‘‘Q4’’ billed on the same claim as a HCPCS ‘‘Q3’’, or in other circumstances, is paid indicates that payment for the code assigned to status indicator ‘‘J1’’, through the CLFS. laboratory test is either packaged if ‘‘J2’’, ‘‘S’’, ‘‘T’’, ‘‘V’’, ‘‘Q1’’, ‘‘Q2’’, or
TABLE 41—PROPOSED CY 2018 STATUS INDICATOR (SI) FOR CPT CODES 81490, 81503, 81535, 81536, 81538, AND 81539
Proposed CPT code Long descriptor CY 2017 CY 2018 OPPS SI OPPS SI
81490 ...... Autoimmune (rheumatoid arthritis), analysis of 12 biomarkers using immunoassays, utilizing Q4 Q4 serum, prognostic algorithm reported as a disease activity score. 81503 ...... Oncology (ovarian), biochemical assays of five proteins (ca-125, apolipoprotein a1, beta-2 micro- Q4 Q4 globulin, transferrin, and pre-albumin), utilizing serum, algorithm reported as a risk score. 81535 ...... Oncology (gynecologic), live tumor cell culture and chemotherapeutic response by dapi stain and Q4 Q4 morphology, predictive algorithm reported as a drug response score; first single drug or drug combination. 81536 ...... Oncology (gynecologic), live tumor cell culture and chemotherapeutic response by dapi stain and Q4 Q4 morphology, predictive algorithm reported as a drug response score; each additional single drug or drug combination (list separately in addition to code for primary procedure). 81538 ...... Oncology (lung), mass spectrometric 8-protein signature, including amyloid a, utilizing serum, Q4 Q4 prognostic and predictive algorithm reported as good versus poor overall survival. 81539 ...... Oncology (high-grade prostate cancer), biochemical assay of four proteins (total psa, free psa, in- Q4 Q4 tact psa, and human kallikrein-2 [hk2]), utilizing plasma or serum, prognostic algorithm reported as a probability score.
Comment: Some commenters protein-based tests, and, as such, the six reflect the appropriate status indicator requested a revision to the status protein-based MAAA codes should be assignment. indicator assignment for the six MAAA reassigned to status indicator ‘‘A’’. Therefore, after consideration of the codes (CPT codes 81490, 81503, 81535, Response: As we stated in the CY public comments, we are finalizing our 81536, 81538, and 81539) from ‘‘Q4’’ to 2017 OPPS/ASC final rule with proposal, without modification, for CPT ‘‘A’’ (Not paid under the OPPS but may codes 81490, 81503, 81535, 81536, comment period (81 FR 79594), we will be paid under a different Medicare 81538, and 81539. As stated earlier, we assign status indicator ‘‘A’’ (Separate payment system), consistent with the will update the OPPS payment file payment under the CLFS) to ADLTs status indicator assignment for the DNA (Addendum B) to appropriately reflect once a laboratory test is designated as an and RNA-based MAAA tests. The the status indicator assignment once a commenters stated that these tests are ADLT under the CLFS. Before a test can CPT code has been designated under the generally not performed in the HOPD be designated as an ADLT, applicants CLFS as an ADLT that meets the criteria setting. Also, the commenters indicated must submit an application for of section 1834A(d)(5)(A) of the Act. that all of the Category I CPT MAAA successful designation as an ADLT by Table 42 below lists the final status codes are already assigned to status CMS. These 6 codes (CPT codes 81490, indicator for the CPT codes. We refer indicator ‘‘A’’ except for CPT codes 81503, 81535, 81536, 81538, and 81539) readers to Addendum B to this final rule 81490, 81503, 81535, 81536, 81538, and have not been designated as ADLTs by with comment period for the payment 81539, which are protein-based MAAA CMS at this time, and therefore we do rates for all codes reported under the codes. The commenters asserted that, not believe they should be reassigned to OPPS. In addition, we refer readers to based on the June 23, 2016 CLFS final status indicator ‘‘A’’. However, once a Addendum A to this final rule with rule entitled ‘‘Medicare Program; code has been designated under the comment period for the status indicator Medicare Clinical Diagnostic Laboratory CLFS as an ADLT that meets the criteria meanings for all codes reported under Tests Payment System,’’ CMS defined of section 1834A(d)(5)(A) of the Act, we the OPPS. Both Addendum A and an ADLT under section 1834A(d)(5)(A) will update the OPPS payment file Addendum B are available via the of the Act to include DNA, RNA, and (Addendum B) on a quarterly basis to Internet on the CMS Web site.
TABLE 42—FINAL CY 2018 STATUS INDICATOR (SI) FOR CPT CODES 81490, 81503, 81535, 81536, 81538, AND 81539
CY 2017 CY 2018 CPT code Long descriptor OPPS SI OPPS SI
81490 ...... Autoimmune (rheumatoid arthritis), analysis of 12 biomarkers using immunoassays, utilizing Q4 Q4 serum, prognostic algorithm reported as a disease activity score. 81503 ...... Oncology (ovarian), biochemical assays of five proteins (ca-125, apolipoprotein a1, beta-2 micro- Q4 Q4 globulin, transferrin, and pre-albumin), utilizing serum, algorithm reported as a risk score. 81535 ...... Oncology (gynecologic), live tumor cell culture and chemotherapeutic response by dapi stain and Q4 Q4 morphology, predictive algorithm reported as a drug response score; first single drug or drug combination. 81536 ...... Oncology (gynecologic), live tumor cell culture and chemotherapeutic response by dapi stain and Q4 Q4 morphology, predictive algorithm reported as a drug response score; each additional single drug or drug combination (list separately in addition to code for primary procedure). 81538 ...... Oncology (lung), mass spectrometric 8-protein signature, including amyloid a, utilizing serum, Q4 Q4 prognostic and predictive algorithm reported as good versus poor overall survival.
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TABLE 42—FINAL CY 2018 STATUS INDICATOR (SI) FOR CPT CODES 81490, 81503, 81535, 81536, 81538, AND 81539—Continued
CY 2017 CY 2018 CPT code Long descriptor OPPS SI OPPS SI
81539 ...... Oncology (high-grade prostate cancer), biochemical assay of four proteins (total psa, free psa, in- Q4 Q4 tact psa, and human kallikrein-2 [hk2]), utilizing plasma or serum, prognostic algorithm reported as a probability score.
15. Musculoskeletal APCs (APC 5111 musculoskeletal procedures (C–APCs Through 5116) 5111 through 5116), as displayed in For CY 2018, we proposed to continue Table 43 below and in Addendum B to the existing C–APCs for the six levels of the CY 2018 OPPS/ASC proposed rule.
TABLE 43—PROPOSED CY 2018 GEOMETRIC MEAN COST AND PAYMENT FOR MUSCULOSKELETAL C–APCS
Proposed CY 2018 CY 2018 C–APC geometric OPPS mean cost payment
5111—Level 1 Musculoskeletal Procedures ...... $222.10 $214 5112—Level 2 Musculoskeletal Procedures ...... 1,311.47 1,261 5113—Level 3 Musculoskeletal Procedures ...... 2,600.94 2,501 5114—Level 4 Musculoskeletal Procedures ...... 5,602.87 5,385 5115—Level 5 Musculoskeletal Procedures ...... 10,310.27 9,913 5116—Level 6 Musculoskeletal Procedures ...... 15,783.57 15,175
Comment: Commenters disagreed 16. Nasal/Sinus Endscopy Procedures describe the complete procedure, with the proposal for six levels of the (C–APC 5155) service, or item described by the CPT musculoskeletal C–APCs and requested For CY 2018, the AMA CPT Editorial code. Therefore, we included the 5-digit that CMS create two additional levels Panel established several new bundled placeholder codes and their long within the musculoskeletal C–APCs. nasal/sinus endoscopy CPT codes. Table descriptors in Addendum O to the The commenters stated concerns about 44 below lists the complete descriptors proposed rule, specifically under the the range of costs of procedures for the new CPT codes. These codes column labeled ‘‘CY 2018 OPPS/ASC assigned to Level 4, Level 5, and Level were listed in Addendum B and Proposed Rule 5-Digit AMA Placeholder 6. The commenters believed that the gap Addendum O to the CY 2018 OPPS/ASC Code’’ so that the public could between the musculoskeletal procedure proposed rule (which is available via adequately comment on our proposed levels and payments is too large and the Internet on the CMS Web site). APC and status indicator assignments. results in APCs that include disparate Addendum B listed the proposed status We also indicated that the final CPT code numbers would be included in this procedures in terms of clinical indicator assignments for the new codes CY 2018 OPPS/ASC final rule with complexity and resource use. and assigned them to comment indicator ‘‘NP’’ (New code for the next comment period. The final CPT code Response: At this time, we continue calendar year or existing code with numbers, along with their to believe that the proposed C–APC substantial revision to its code corresponding 5-digit placeholder levels for the musculoskeletal descriptor in the next calendar year as codes, can be found in Table 45 below. procedures C–APC family provide an compared to current calendar year, As displayed in Table 44 below and appropriate distinction between the proposed APC assignment; comments in Addendum B of the CY 2018 OPPS/ resource costs at each level and provide will be accepted on the proposed APC ASC proposed rule, we proposed to clinical homogeneity. We will continue assignment for the new code), while assign CPT code 31241 to status to review this C–APC structure to Addendum O listed the proposed/ indicator ‘‘C’’ to indicate that this is an determine if additional granularity is placeholder CY 2018 CPT codes and the inpatient only procedure, and to assign necessary for this C–APC family. long descriptors. We note that the CPT CPT codes 31253, 31257, 31259, and code descriptors that appeared in the 31298 to C–APC 5155 (Level 5 Airway OPPS Addendum B were short Endoscopy), with a proposed payment descriptors and did not accurately rate of $4,628.89.
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TABLE 44—PROPOSED CY 2018 STATUS INDICATOR (SI), APC ASSIGNMENT, AND PAYMENT RATES FOR THE NEW NASAL/SINUS ENDOSCOPY CPT CODES EFFECTIVE JANUARY 1, 2018
CY 2018 Proposed OPPS/ASC Proposed Proposed CY 2018 CPT code proposed rule Long descriptor CY 2018 CY 2018 OPPS placeholder OPPS SI OPPS APC payment code rate
31241 ...... 31XX1 ...... Nasal/sinus endoscopy, surgical; with ligation of sphenopalatine C N/A N/A artery. 31253 ...... 31XX2 ...... Nasal/sinus endoscopy, surgical with ethmoidectomy; total (ante- J1 5155 $4,628.89 rior and posterior), including frontal sinus exploration, with re- moval of tissue from frontal sinus, when performed. 31257 ...... 31XX3 ...... Nasal/sinus endoscopy, surgical with ethmoidectomy; total (ante- J1 5155 4,628.89 rior and posterior), including sphenoidotomy. 31259 ...... 31XX4 ...... Nasal/sinus endoscopy, surgical with ethmoidectomy; total (ante- J1 5155 4,628.89 rior and posterior), including sphenoidotomy, with removal of tissue from the sphenoid sinus. 31298 ...... 31XX5 ...... Nasal/sinus endoscopy, surgical; with dilation of frontal and sphe- J1 5155 4,628.89 noid sinus ostia (e.g., balloon dilation).
Comment: Several commenters that we should assign these codes to C– separately through the ASC payment expressed concern with the APC APC 5155 where similar endoscopic system are paid based on the standard placement and indicated that sinus procedures are assigned. ASC methodology (81 FR 79738). We assignment to C–APC 5155 in the OPPS With regards to the comment refer readers to section II.A.2.b. would reduce the ASC payment for the recommending separate payment for the (Comprehensive APCs) of this final rule procedures by 32 percent. The single endoscopic sinus procedures with comment period for the discussion commenters requested that CMS assign performed in 2017, because the codes on the payment methodology for C– the new bundled codes to a higher describing single endoscopic sinus APCs and to section XII. (ASC Payment paying APC to provide appropriate surgery are assigned to status indicator System) of this final rule with comment payment in the ASC setting. Some ‘‘J1’’, HOPDs receive one payment for period for the discussion on the ASC commenters clarified that, in CY 2017, the multiple surgeries, regardless of the Payment System. For the history on the these bundled procedures were reported number of endoscopic sinus procedures establishment of C–APCs under the under two separate codes that were performed in a day. The status indicator OPPS, we refer readers to the CY 2014 separately payable. Because of the effect assignment of ‘‘J1’’ to C–APC 5155 OPPS/ASC final rule (78 FR 74861– on the ASC payment, the commenters indicates that the APC is designated as 4910). recommended that CMS establish a new a comprehensive APC (C–APC) under In summary, after consideration of the APC for multiple (five or more) sinus the OPPS. C–APCs provide a single public comments we received, we are procedures, reconfigure the airway payment for a primary service, and finalizing our proposal for CPT codes APCs to better recognize the complexity payment for all adjunctive services 31241, 31253, 31257, 31259, and 31298 associated with performing multiple reported on the same claim is packaged without modification. Consistent with sinus procedures in a single surgery, or into payment for the primary service. the statutory requirement under section create a complexity adjustment for sinus With few exceptions, all other services 1833(t)(9)(A) of the Act, we will procedures billed with a device or drug reported on a hospital outpatient claim reevaluate the APC assignment for these HCPCS C-code or J-code. in combination with the primary service codes in the next rulemaking cycle. Response: C–APC 5155 contains are considered to be related to the Table 45 below lists the final status several endoscopic sinus procedures, delivery of the primary service and indicator and APC assignments for CPT including the single endoscopic sinus packaged into the single payment for the codes 31241, 31253, 31257, 31259, and surgeries. Based on input from our primary service and, therefore, separate 31298 for CY 2018. We refer readers to medical advisors, we believe this APC is payment is not available. We note that Addendum B to this final rule with the most appropriate assignment for C–APCs do not apply to ASCs; comment period for the payment rates CPT codes 31253, 31257, 31259, and consequently, the procedures would not for all codes reported under the OPPS. 31298. C–APC 5155, which has a final be packaged. Instead, the procedures In addition, we refer readers to rule geometric mean cost of would be separately payable in the ASC Addendum A to this final rule with approximately $4,861, is currently the setting. As we stated in the CY 2017 comment period for the status indicator highest paying APC within the airway OPPS/ASC final rule with comment meanings for all codes reported under endoscopy APC series. Because CPT period, we did not implement C–APCs the OPPS. Both Addendum A and codes 31253, 31257, 31259, and 31298 in the ASC payment system, and Addendum B are available via the are new codes for CY 2018, we believe consequently, procedures paid Internet on the CMS Web site.
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TABLE 45—FINAL CY 2018 STATUS INDICATOR (SI) AND APC ASSIGNMENT FOR THE NEW NASAL/SINUS ENDOSCOPY CPT CODES EFFECTIVE JANUARY 1, 2018
CY 2018 OPPS/ASC CY 2018 CPT code proposed rule Long descriptor CY 2018 CY 2018 OPPS payment placeholder OPPS SI OPPS APC rate code
31241 ...... 31XX1 ...... Nasal/sinus endoscopy, surgical; with ligation of C N/A Refer to OPPS sphenopalatine artery. Addendum B. 31253 ...... 31XX2 ...... Nasal/sinus endoscopy, surgical with ethmoidectomy; total J1 5155 Refer to OPPS (anterior and posterior), including frontal sinus exploration, Addendum B. with removal of tissue from frontal sinus, when performed. 31257 ...... 31XX3 ...... Nasal/sinus endoscopy, surgical with ethmoidectomy; total J1 5155 Refer to OPPS (anterior and posterior), including sphenoidotomy. Addendum B. 31259 ...... 31XX4 ...... Nasal/sinus endoscopy, surgical with ethmoidectomy; total J1 5155 Refer to OPPS (anterior and posterior), including sphenoidotomy, with re- Addendum B. moval of tissue from the sphenoid sinus. 31298 ...... 31XX5 ...... Nasal/sinus endoscopy, surgical; with dilation of frontal and J1 5155 Refer to OPPS sphenoid sinus ostia (eg, balloon dilation). Addendum B.
17. Nuclear Medicine Services (APCs assign CPT codes 78018 and 78121 to 78111 to APC 5593 (Level 3 Nuclear 5592 and 5593) APC 5592 (Level 2 Nuclear Medicine Medicine and Related Services). For CY 2018, as illustrated in Table 46 and Related Services) and to also below, we proposed to continue to continue to assign CPT codes 78110 and
TABLE 46—PROPOSED CY 2018 STATUS INDICATOR (SI), APC ASSIGNMENT, AND PAYMENT RATE FOR CPT CODES 78018, 78110, 78111, AND 78121
Proposed CY 2017 Proposed Proposed CY 2018 CPT code Long descriptor CY 2017 CY 2017 OPPS CY 2018 CY 2018 OPPS OPPS SI OPPS APC payment OPPS SI OPPS APC payment rate Rate
78018 ...... Thyroid carcinoma metastases imag- S 5592 $429.13 S 5592 $439.56 ing; whole body. 78110 ...... Plasma volume, radiopharmaceutical S 5593 1,138.94 S 5593 1,163.30 volume-dilution technique (separate procedure); single sampling. 78111 ...... Plasma volume, radiopharmaceutical S 5593 1,138.94 S 5593 1,163.30 volume-dilution technique (separate procedure); multiple samplings. 78121 ...... Red cell volume determination (sepa- S 5592 429.13 S 5592 439.56 rate procedure); multiple samplings.
Comment: One commenter stated that ‘‘CH’’ to indicate that their APC approximately $457 for APC 5592, we CMS proposed to reassign CPT codes assignments were revised. However, as proposed to maintain the assignment of 78018, 78110, 78111 and 78121 to new displayed in Table 46, we proposed to this code to APC 5592. For CPT code APC groups, and recommended that make no change to the APC assignments 78110, our claims data showed a CMS maintain the CPT codes in the for all four codes for the CY 2018 OPPS geometric mean cost of approximately ‘‘new APC groups’’ to ensure stability update. Specifically, we proposed to $1,046 based on 12 single claims (out of within the coding structure. The continue to assign CPT codes 78018, 14 total claims). We believe that the commenter added that CMS has moved 78110, 78111, and 78121 to the same CY geometric mean cost of $1,046 for CPT these codes several times over the years 2017 APCs for CY 2018 based on claims code 78110 is comparable to the and believed they are currently assigned data used for the CY 2018 OPPS/ASC geometric mean cost of approximately to appropriate APC groups. This proposed rule. We note that the $1,210 for APC 5593. Consequently, we commenter noted that the codes are low proposed rule data was based on claims proposed to maintain the assignment of volume with high costs, and data submitted between January 1, 2016, this code to APC 5593. For CPT code recommended that CMS defer to the and December 31, 2016, that were 78111, we had no claims data. However, specialty societies for appropriate APC processed on or before December 31, based on its clinical similarity to CPT assignment. 2016. For CPT code 78018, our code 78110, we proposed to continue to Response: For the CY 2017 update, as examination of the claims data revealed assign the CPT code to APC 5593. For indicated in the OPPS Addendum B that a geometric mean cost of approximately CPT code 78121, our analysis revealed was released with the CY 2017 OPPS/ $418 based on 5,604 single claims (out a geometric mean cost of approximately ASC final rule with comment period, we of 6,327 total claims). Because the $807 based on 3 single claims (out of 3 assigned CPT codes 78018, 78110, geometric mean cost of $418 is similar total claims). Based on the low volume 78111 and 78121 to comment indicator to the geometric mean cost of and because revising the assignment to
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APC 5593, which had a proposed code 78111, we again had no claims appropriate APC placement for geometric mean cost of approximately data. However, because of its clinical designated codes, while we rely on our $1,210 would result in an overpayment similarity to CPT code 78110, we will latest claims data to appropriately set for the test, we proposed to continue to maintain the assignment to APC 5593. payment rates under the OPPS, we assign CPT code 78121 to APC 5592, For CPT code 78121, we found a welcome and appreciate comments from and to review the claims data for the geometric mean cost of approximately all stakeholders on our proposals. We final rule to determine whether a $808 based on 3 single claims (out of 3 note that every year we publish the revision to the APC assignment would total claims). Based on the comment OPPS/ASC proposed rules with requests be necessary. received that the APC assignment is for public comments on the OPPS and For this final rule with comment appropriate, we will retain CPT code ASC payment assignments from period, we again analyzed updated 78121 in APC 5592, whose geometric interested parties, including hospitals, claims data associated with the four mean cost is approximately $453, for CY specialty societies, physicians, nurses, codes. We note that, for this final rule 2018. In addition, given the low volume health care technicians, other health with comment period, we used claims for the CPT code, we do not believe that care professionals, interested data with dates of service between we should reassign CPT code 78121 to individuals, patients, and any other January 1, 2016, and December 31, 2016, APC 5593, whose geometric mean cost stakeholders interested on commenting that were processed on or before June is approximately $1,202 for CY 2018. To on our proposed payment assignments. 30, 2017. Our review of the final rule reassign CPT code 78121 to APC 5593 claims data revealed a similar pattern would result in an overpayment for CPT In summary, after consideration of the for all four codes. For CPT code 78018, code 78121. public comment we received, we are we found a geometric mean cost of Further, we remind the commenter, finalizing our CY 2018 proposals, approximately $418 based on 6,113 that as we do every year, we review the without modification, for CPT codes single claims (out of 6,923 total claims), latest OPPS claims data to set the 78018, 78110, 78111, and 78121. Table which is similar to the geometric mean payment rates for the following year. 47 below lists the final status indicator cost of approximately $453 for APC Section 1833(t)(9) of the Act requires and APC assignments for the CPT codes. 5592. Consequently, we believe that it that we annually review all the items We refer readers to Addendum B to this continues to be appropriate to assign and services within an APC group and final rule with comment period for the CPT code 78018 to APC 5592. For CPT revise the APC structures accordingly. payment rates for all codes reported code 78110, our claims data revealed a Included in this review is the under the OPPS. In addition, we refer geometric mean cost of approximately identification of any 2 times rule readers to Addendum A to this final $1,037 based on 12 single claims (out of violations as provided under section rule with comment period for the status 14 total claims), which is similar to the 1833(t)(2) of the Act and, to the extent indicator meanings for all codes geometric mean cost of approximately possible, rectification of these reported under the OPPS. Both $1,202 for APC 5593. violations. Addendum A and Addendum B are Consequently, we are maintaining With regard to the comment of available via the Internet on the CMS CPT code 78110 in APC 5593. For CPT deferring to specialty societies for Web site.
TABLE 47—FINAL CY 2018 STATUS INDICATOR (SI) AND APC ASSIGNMENT FOR CPT CODES 78018, 78110, 78111, AND 78121
CY 2017 CY 2017 CY 2017 OPPS CY 2018 CY 2018 CY 2018 CPT code Long descriptors OPPS SI OPPS APC payment OPPS SI OPPS APC OPPS rate payment rate
78018 ...... Thyroid carcinoma metastases S 5592 $429.13 S 5592 Refer to OPPS imaging; whole body. Addendum B. 78110 ...... Plasma volume, radiopharma- S 5593 1,138.94 S 5593 Refer to OPPS ceutical volume-dilution tech- Addendum B. nique (separate procedure); sin- gle sampling. 78111 ...... Plasma volume, radiopharma- S 5593 1,138.94 S 5593 Refer to OPPS ceutical volume-dilution tech- Addendum B. nique (separate procedure); multiple samplings. 78121 ...... Red cell volume determination S 5592 429.13 S 5592 Refer to OPPS (separate procedure); multiple Addendum B. samplings.
18. Percutaneous Transluminal 2018 OPPS/ASC proposed rule, we reassign CPT codes 37184 and 37187 Mechanical Thrombectomy (C–APC proposed to revise the APC assignment from APC 5183 (Level 3 Vascular 5192) for the percutaneous transluminal Procedures) to APC 5184 (Level 4 mechanical thrombectomy procedures, Vascular Procedures), with a proposed For CY 2018, as noted in Table 48 specifically, CPT codes 37184 and payment rate of $4,084.25. below and in Addendum B to the CY 37187. Specifically, we proposed to
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TABLE 48—PROPOSED CY 2018 U (SI), APC ASSIGNMENT, AND PAYMENT RATE FOR CPT CODES 37184 AND 37187
Proposed CY 2017 Proposed Proposed CY 2018 CPT code Long descriptor CY 2017 CY 2017 OPPS CY 2018 CY 2018 OPPS OPPS SI OPPS APC payment OPPS SI OPPS APC payment rate rate
37184 ...... Primary percutaneous transluminal T 5183 $3,924.28 T 5184 $4,084.25 mechanical thrombectomy, noncoro- nary, non-intracranial, arterial or ar- terial bypass graft, including fluoroscopic guidance and intraprocedural pharmacological thrombolytic injection(s); initial ves- sel. 37187 ...... Percutaneous transluminal mechanical T 5183 3,924.28 T 5184 4,084.25 thrombectomy, vein(s), including intraprocedural pharmacological thrombolytic injections and fluoroscopic guidance.
Comment: One commenter requested updated CY 2016 claims data associated $10,504. However, based on our review, that CMS revise the proposed APC with CPT codes 37184 and 37187. We we believe that C–APC 5192 is more assignment for CPT codes 37184 and note that, for this final rule with appropriate. Therefore, based on their 37187 from APC 5184 to C–APC 5192 comment period, we used claims data clinical homogeneity and resource costs based on their clinical and resource with dates of service between January 1, in relation to the other procedures homogeneity to the procedures assigned 2016, and December 31, 2016, that were assigned to C–APC 5192, we agree with to C–APC 5192 (Level 2 Endovascular processed on or before June 30, 2017. the commenter that C–APC 5192 is the Procedures). The commenter indicated Our analysis of the final rule claims data most appropriate APC assignment for that both procedures are clinically revealed that a change in the APC CPT codes 37184 and 37187. similar to other percutaneous assignment for CPT codes 37184 and After consideration of the public transluminal procedures assigned to C– 37187 to C–APC 5192 (rather than comment we received, we are finalizing APC 5192, including CPT code 36904 proposed APC 5184) is appropriate. our CY 2018 proposal, with (Percutaneous transluminal mechanical Specifically, we found a geometric mean modification, for CPT codes 37184 and thrombectomy and/or infusion for cost of approximately $8,459 for CPT 37187. Specifically, we are reassigning thrombolysis, dialysis circuit, any code 37184 based on 149 single claims CPT codes 37184 and 37187 from APC method, including all imaging and (out of 150 total claims), and a 5183 to C–APC 5192 for CY 2018. As we radiological supervision and geometric mean cost of approximately do every year under the OPPS, we will interpretation, diagnostic angiography, $6,343 for CPT code 37187 based on 188 reevaluate the cost of CPT codes 37184, fluoroscopic guidance, catheter single claims (out of 190 total claims). and 37187 and their APC assignment for placement(s), and intraprocedural We believe that the geometric mean next year’s OPPS update. Table 49 pharmacological thrombolytic costs for CPT codes 37184 and 37187 below lists the final status indicator and injection(s)), which CMS proposed to are more similar to the geometric mean APC assignments for both CPT codes. assign to C–APC 5192 for CY 2018, with costs of other procedures assigned to C– We refer readers to Addendum B to this a proposed payment of $4,999.36. This APC 5192, whose geometric mean cost final rule with comment period for the commenter added that the geometric is approximately $5,082, rather than the payment rates for all codes reported mean costs associated with the geometric mean costs of procedures under the OPPS. In addition, we refer procedures described by CPT codes assigned to APC 5184, whose geometric readers to Addendum A to this final 37184 and 37187 are similar to the mean cost is approximately $4,262. We rule with comment period for the status geometric mean costs of other note that we also considered whether indicator meanings for all codes procedures currently assigned to C–APC we should reassign CPT codes 37184 reported under the OPPS. Both 5192. and 37187 to C–APC 5193 (Level 3 Addendum A and Addendum B are Response: For this final rule with Endovascular Procedures), which has a available via the Internet on the CMS comment period, we reviewed the geometric mean cost of approximately Web site.
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TABLE 49—FINAL CY 2018 STATUS INDICATOR (SI) AND APC ASSIGNMENT FOR CPT CODES 37184 AND 37187
CY 2017 CY 2017 CY 2017 OPPS CY 2018 CY 2018 CY 2018 CPT code Long descriptor OPPS SI OPPS APC payment OPPS SI OPPS APC OPPS payment rate rate
37184 ...... Primary percutaneous T 5183 $3,924.28 J1 5192 Refer to OPPS transluminal mechanical Addendum B. thrombectomy, noncoronary, non-intracranial, arterial or arte- rial bypass graft, including fluoroscopic guidance and intraprocedural pharmacological thrombolytic injection(s); initial vessel. 37187 ...... Percutaneous transluminal me- T 5183 3,924.28 J1 5192 Refer to OPPS chanical thrombectomy, vein(s), Addendum B. including intraprocedural phar- macological thrombolytic injec- tions and fluoroscopic guidance.
19. Peripherally Inserted Central Venous code 36569 from APC 5181 (Level 1 Catheter (PICC) (APC 5182) Vascular Procedures) to APC 5182 For CY 2018, as noted in Table 50 (Level 2 Vascular Procedures), with a below, we proposed to reassign CPT proposed payment rate of $945.33.
TABLE 50—PROPOSED CY 2018 STATUS INDICATOR (SI), APC ASSIGNMENT, AND PAYMENT RATE FOR CPT CODE 36569
Proposed CY 2017 Proposed Proposed CY 2018 CPT code Long descriptor CY 2017 CY 2017 OPPS CY 2018 CY 2018 OPPS OPPS SI OPPS APC payment OPPS SI OPPS APC payment rate rate
36569 ...... Insertion of peripherally inserted cen- T 5181 $684.13 T 5182 $945.33 tral venous catheter (picc), without subcutaneous port or pump; age 5 years or older.
We proposed to revise the APC the geometric mean cost of more appropriately reflects the assignment for CPT code 36569 based approximately $983 for APC 5182. resources to perform the procedure. on claims data used for the CY 2018 For this final rule with comment Response: We appreciate the OPPS/ASC proposed rule. We note that period, we again reviewed the updated commenter’s support. Based on our the proposed rule data was based on claims data associated with CPT code latest analysis of the final rule claims claims data submitted between January 36569. We note that, for this final rule data, we are finalizing our proposal to 1, 2016, and December 31, 2016, that with comment period, we used claims reassign CPT code 36569 from APC were processed on or before December data with dates of service between 5181 to APC 5182. In summary, after consideration of the 31, 2016. Our analysis of the proposed January 1, 2016, and December 31, 2016, public comment we received, we are rule claims data revealed a geometric that were processed on or before June finalizing our CY 2018 proposal, mean cost of approximately $934 for 30, 2017. Our analysis of the final rule without modification, to reassign CPT CPT code 36569 based on 29,514 single claims data revealed a similar pattern code 36569 to APC 5182. Table 51 claims (out of 52,035 total claims). Our for CPT code 36569. Specifically, we below lists the final status indicator and analysis further revealed a geometric found a geometric mean cost of APC assignments for CPT code 36569 mean cost of approximately $983 for approximately $929 for CPT code 36569 for CY 2018. We refer readers to APC 5182 and $610 for APC 5181. based on 31,559 single claims (out of Addendum B to this final rule with Based on the geometric mean costs of 56,891 total claims). We also found the comment period for the payment rates APCs 5181 and 5182, we believed it was geometric mean cost of approximately for all codes reported under the OPPS. necessary to revise the APC assignment $982 for APC 5182 to be similar to the In addition, we refer readers to for CPT code 36569 from APC 5181 to geometric mean cost of CPT code 36569 Addendum A to this final rule with APC 5182 to pay appropriately for the compared to the geometric mean cost of comment period for the status indicator procedure. Consequently, we proposed approximately $612 for APC 5181. meanings for all codes reported under to revise the APC assignment for CPT Comment: One commenter supported the OPPS. Both Addendum A and code 36569, whose geometric mean cost the proposed APC reassignment for CPT Addendum B are available via the of approximately $934 is comparable to code 36569 and stated that APC 5182 Internet on the CMS Web site.
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TABLE 51—FINAL CY 2018 STATUS INDICATOR (SI) AND APC ASSIGNMENT FOR CPT CODE 36569
CY 2017 CY 2017 CY 2017 OPPS CY 2018 CY 2018 CY 2018 CPT code Long descriptor OPPS SI OPPS APC payment OPPS SI OPPS APC OPPS payment rate rate
36569 ...... Insertion of peripherally inserted T 5181 $684.13 T 5182 Refer to OPPS central venous catheter (picc), Addendum B. without subcutaneous port or pump; age 5 years or older.
20. Pulmonary Rehabilitation Services cardiac rehabilitation services codes. 3 Minor Procedures) for CY 2018. In (APCs 5732 and 5733) and Cardiac Currently, there are four HCPCS codes addition, there are currently four Rehabilitation Services (APC 5771) that describe pulmonary rehabilitation HCPCS codes that describe the cardiac services, specifically, HCPCS codes rehabilitation services, specifically, For CY 2018, as displayed in Table 52 G0237, G0238, G0239, and G0424. For HCPCS codes 93797, 93798, G0422, and below, and as listed in Addendum B of CY 2018, we proposed to continue to G0423. For CY 2018, we proposed to the CY 2018 OPPS/ASC proposed rule, assign HCPCS codes G0237, G0238, and continue to assign the cardiac we did not propose to make any change G0239 to APC 5732 (Level 2 Minor rehabilitation services codes to APC to the APC assignments for the Procedures) and to continue to assign 5771 (Cardiac Rehabilitation) for CY pulmonary rehabilitation services and HCPCS code G0424 to APC 5733 (Level 2018.
TABLE 52—PROPOSED CY 2018 STATUS INDICATOR (SI), APC ASSIGNMENT, AND PAYMENT RATE FOR THE PULMONARY REHABILITATION SERVICES AND CARDIAC REHABILITATION SERVICES HCPCS CODES
Proposed CY 2017 Proposed Proposed CY 2018 HCPCS code Long descriptor CY 2017 CY 2017 OPPS CY 2018 CY 2018 OPPS OPPS SI OPPS APC payment OPPS SI OPPS APC payment rate rate
Pulmonary Rehabilitation Services
G0237 ...... Therapeutic procedures to increase S 5732 $28.38 S 5732 $29.65 strength or endurance of respiratory muscles, face to face, one on one, each 15 minutes (includes moni- toring). G0238 ...... Therapeutic procedures to improve S 5732 28.38 S 5732 29.65 respiratory function, other than de- scribed by g0237, one on one, face to face, per 15 minutes (includes monitoring). G0239 ...... Therapeutic procedures to improve S 5732 28.38 S 5732 29.65 respiratory function or increase strength or endurance of respiratory muscles, two or more individuals (includes monitoring). G0424 ...... Pulmonary rehabilitation, including ex- S 5733 54.55 S 5733 53.22 ercise (includes monitoring), one hour, per session, up to two ses- sions per day.
Cardiac Rehabilitation Services
93797 ...... Physician or other qualified health S 5771 $110.22 S 5771 $113.71 care professional services for out- patient cardiac rehabilitation; with- out continuous ecg monitoring (per session). 93798 ...... Physician or other qualified health S 5771 110.22 S 5771 113.71 care professional services for out- patient cardiac rehabilitation; with continuous ecg monitoring (per ses- sion). G0422 ...... Intensive cardiac rehabilitation; with or S 5771 110.22 S 5771 113.71 without continuous ecg monitoring with exercise, per session. G0423 ...... Intensive cardiac rehabilitation; with or S 5771 110.22 S 5771 113.71 without continuous ecg monitoring; without exercise, per session.
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Comment: Several commenters In addition, we found a geometric mean HCPCS codes (between $101 to $224), expressed concern that the payment cost of approximately $45 for HCPCS we believe that the geometric mean cost rates for the pulmonary rehabilitation code G0424 (based on 468,571 single of approximately $117 for APC 5771 services are significantly less than those claims) that is comparable to the appropriately reflects the resources in for the cardiac rehabilitation services. geometric mean cost of approximately providing cardiac rehabilitation The commenters stated that, despite the $55 for APC 5733. Therefore, we services. legislative and clinical similarity proposed to continue to assign HCPCS In addition, while the commenters between both services, CMS has taken code G0424 to APC 5733. believed that pulmonary and cardiac different approaches to implementing For the cardiac rehabilitation services, rehabilitation services are similar, our the services, with pulmonary our analysis revealed a geometric mean analysis of the available OPPS data rehabilitation services paid less than cost of approximately $101 for HCPCS reveals that their costs are significantly cardiac rehabilitation services. One code 93797 (based on 129,124 single different. Consequently, we do not agree commenter indicated that, since 2010, claims), $118 for HCPCS code 93798 that we should assign both services to the code describing pulmonary (based on 2,698,534 single claims), $212 one APC, or even assign the pulmonary rehabilitation services has had three for HCPCS code G0422 (based on 38,094 rehabilitation HCPCS code G0424 to the different status indicator assignments single claims), and $174 for HCPCS cardiac rehabilitation services group and payment volatility. This commenter code G0423 (based on 18,001 single (APC 5771). We note that the recommended that CMS reassign the claims). Because the range of costs commenters did not provide data to pulmonary rehabilitation HCPCS code (between $101 and $212) for the cardiac suggest that the hospital reported costs G0464 from APC 5733 to the cardiac rehabilitation services are comparable to in our data are incorrect or that the rehabilitation APC group, specifically, the geometric mean cost of resources (costs) incurred to furnish APC 5771. Another commenter approximately $118 for APC 5771, we these two types of services are equal. recommended that CMS revisit its proposed to continue to assign the Accordingly, we have no reason to approach to payment for pulmonary cardiac rehabilitation HCPCS codes to believe that the data reported to us by rehabilitation services to improve access APC 5771 for CY 2018. hospitals are incorrect. to care. One commenter recommended For this final rule with comment Moreover, we do not agree that we that both types of services be placed in period, we again analyzed the updated should create a composite APC for the one composite APC under the OPPS. claims data associated with the pulmonary and cardiac rehabilitation Response: The payment rates for both pulmonary and cardiac rehabilitation services. Composite APCs provide a the pulmonary and cardiac services. We note that, for this final rule single payment for groups of services rehabilitation services are based on with comment period, we used claims that are typically performed together claims data that are analyzed each year. data with dates of service between during a single clinical encounter that As we do every year, we review the January 1, 2016, and December 31, 2016, result in the provision of a complete latest OPPS claims data to set the that were processed on or before June service. Combining payment for payment rates for the following year. We 30, 2017. Similar to our proposed rule multiple, independent services into a note that section 1833(t)(9) of the Act findings, we found the costs to be single OPPS payment in this way requires that we annually review all the different for both services. enables hospitals to manage their items and services within an APC group For the pulmonary rehabilitation resources with maximum flexibility by and revise the APC structures services, our final rule claims data monitoring and adjusting the volume accordingly. Included in this review is revealed a geometric mean cost of and efficiency of services themselves. the identification of any 2 times rule approximately $25 for HCPCS code Establishing a composite APC for these violations as provided under section G0237 (based on 22,097 single claims), services would not be appropriate 1833(t)(2) of the Act and, to the extent $22 for HCPCS code G0238 (based on because pulmonary and cardiac possible, rectification of these 18,900 single claims), and $33 for rehabilitation services are generally not violations. HCPCS code G0239 (based on 187,134 performed on the same day. We refer For the proposed rule, we based the single claims). Based on the range of readers to the CY 2008 OPPS/ASC final proposed payment rates on claims data costs (between $22 and $33), we believe rule with comment period for a full submitted between January 1, 2016, and that HCPCS codes G0237, G0238, and discussion of the development of the December 31, 2016, that were processed G0239 are appropriately assigned to composite APC methodology (72 FR on or before December 31, 2016. Based APC 5732, whose geometric mean cost 66611 through 66614 and 66650 through on our analysis, we found the costs for is approximately $32. Similarly, we 66652) and the CY 2012 OPPS/ASC both types of services to be significantly believe that the geometric mean cost of final rule with comment period (76 FR different. approximately $44 (based on 514,478 74163) for more recent background. For the pulmonary rehabilitation single claims) for HCPCS code G0424 is Comment: Some commenters stated services, our analysis revealed a comparable to the geometric mean costs that, despite evidence that pulmonary geometric mean cost of approximately of those services assigned to APC 5733, rehabilitation is a valuable service, few $26 for HCPCS code G0237 (based on whose geometric mean cost is patients with chronic obstructive 19,925 single claims), $22 for HCPCS approximately $56 for CY 2018. pulmonary disease (COPD) are able to code G0238 (based on 17,361 single For the cardiac rehabilitation services, access this treatment. The commenters claims), and $33 for HCPCS code G0239 our final rule claims data revealed a further indicated that a study of (based on 168,295 single claims). We geometric mean cost of approximately Medicare beneficiaries revealed that note that the range of costs (between $26 $224 for HCPCS code G0422 (based on only 3.7 percent of COPD patients and $33) for HCPCS codes G0237, 44,754 single claims), $186 for HCPCS received pulmonary rehabilitation in G0238, and G0239 are similar to the code G0423 (based on 22,188 single 2012, and believe this number may be geometric mean cost of approximately claims), $101 for HCPCS code 93797 higher for non-Medicare beneficiaries. $31 for APC 5732. Consequently, we (based on 143,507 single claims), and The commenters noted that payment for proposed to continue to assign all three $116 for HCPCS code 93798 (based on pulmonary rehabilitation is lower than pulmonary rehabilitation services 2,991,759 single claims). Based on the cardiac rehabilitation (a similar service) HCPCS codes to APC 5732 for CY 2018. costs for the cardiac rehabilitation in the Medicare program, and believed
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this difference is based on idiosyncratic one or more HCPCS codes. Payment and another for the professional services hospital billing and OPPS rules, not varies according to the APC group to under the MPFS. based on rational policy or evidence. which the independent service or In addition, as illustrated in Table 52– Specifically, the commenter indicated combination of services is assigned. 1 below, the number of services paid by that, for CY 2017, payment for 1 hour Under the Medicare program, we pay Medicare for both cardiac rehabilitation of pulmonary rehabilitation is $54.55 separately for both cardiac and and pulmonary rehabilitation has grown under the OPPS. These commenters pulmonary rehabilitation services. We suggested that the payment discrepancy have not found evidence that there is an in the last several years. For the CY between cardiac services and access to care issue for pulmonary 2018 OPPS update, our claims data pulmonary rehabilitation services may rehabilitation services compared to reveal over 514,000 single claims for be a contributing factor to inadequate cardiac rehabilitation services. We note pulmonary rehabilitation services as access of the pulmonary rehabilitation that there are a variety of treatment described by HCPCS code G0424 alone. services. options for patients with COPD and Accordingly, we do not believe that Response: As stated in section III.B. of pulmonary rehabilitation remains a beneficiary access to pulmonary this final rule with comment period, covered service for those beneficiaries rehabilitation services is inadequate. payments for OPPS services and for whom physicians order this service. Details pertaining to the volume of these procedures are based on our analysis of We note that, under the Medicare services furnished in the physician the latest claims data. Under the OPPS, program, when the service is provided office setting can be derived from the we pay for covered hospital outpatient in the hospital outpatient setting, we CY 2018 MPFS final rule and associated services on a rate-per-service basis, make two payments, one to the hospital public use files. where the service may be reported with outpatient department under the OPPS
TABLE 52–1—OPPS CLAIMS DATA FOR THE PULMONARY AND CARDIAC (INCLUDING INTENSIVE CARDIAC) REHABILITATION HCPCS CODES FOR THE CY 2014 THROUGH CY 2018 OPPS UPDATES
2014 OPPS 2015 OPPS 2016 OPPS 2017 OPPS 2018 OPPS HCPCS code Short descriptor single claims single claims single claims single claims single claims data data data data data
Cardiac Rehabilitation Services
93797 ...... Cardiac rehab ...... 87,689 94,769 109,420 120,821 143,507 93798 ...... Cardiac rehab/monitor...... 2,428,984 2,481,175 2,581,446 2,761,806 2,991,759 G0422 ...... Intens cardiac rehab w/exerc ...... 12,060 12,043 17,646 30,165 44,754 G0423 ...... Intens cardiac rehab no exer ...... 703 1,325 6,654 11,979 22,188
Pulmonary Rehabilitation Services
G0237 ...... Therapeutic procd strg endur ...... 15,337 43,591 47,046 19,098 22,097 G0238 ...... Oth resp proc, indiv ...... 14,437 22,736 23,960 18,482 18,900 G0239 ...... Oth resp proc, group ...... 132,475 111,755 127,425 165,799 187,134 G0424 ...... Pulmonary rehab w exer ...... 457,226 459,572 454,121 443,777 514,478
In summary, after consideration of the assignment of the pulmonary and payment rates for all codes reported public comments we received and after cardiac rehabilitation HCPCS codes, under the OPPS. In addition, we refer our analysis of the updated claims data without modification, for CY 2018. As readers to Addendum A to this final for this final rule with comment period, we do every year, we will review our rule with comment period for the status we believe that the current APC claims data for these services for the CY indicator meanings for all codes assignments for the pulmonary and 2019 OPPS rulemaking. Table 53 below reported under the OPPS. Both cardiac rehabilitation services lists the final status indicator and APC Addendum A and Addendum B are appropriately reflects their clinical assignments for the codes for pulmonary available via the Internet on the CMS coherence and resource costs. and cardiac rehabilitation services. We Web site. Consequently, we are finalizing our refer readers to Addendum B to this proposal to continue the current APC final rule with comment period for the
TABLE 53—FINAL CY 2018 STATUS INDICATOR (SI) AND APC ASSIGNMENT FOR THE PULMONARY REHABILITATION SERVICES AND CARDIAC REHABILITATION SERVICES
CY 2017 CY 2017 CY 2017 OPPS CY 2018 CY 2018 CY 2018 HCPCS code Long descriptor OPPS SI OPPS APC payment OPPS SI OPPS APC OPPS rate payment rate
Pulmonary Rehabilitation Services
G0237 ...... Therapeutic procedures to in- S 5732 $28.38 S 5732 Refer to OPPS crease strength or endurance of Addendum B. respiratory muscles, face to face, one on one, each 15 min- utes (includes monitoring).
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TABLE 53—FINAL CY 2018 STATUS INDICATOR (SI) AND APC ASSIGNMENT FOR THE PULMONARY REHABILITATION SERVICES AND CARDIAC REHABILITATION SERVICES—Continued
CY 2017 CY 2017 CY 2017 OPPS CY 2018 CY 2018 CY 2018 HCPCS code Long descriptor OPPS SI OPPS APC payment OPPS SI OPPS APC OPPS rate payment rate
G0238 ...... Therapeutic procedures to im- S 5732 28.38 S 5732 Refer to OPPS prove respiratory function, other Addendum B. than described by g0237, one on one, face to face, per 15 minutes (includes monitoring). G0239 ...... Therapeutic procedures to im- S 5732 28.38 S 5732 Refer to OPPS prove respiratory function or in- Addendum B. crease strength or endurance of respiratory muscles, two or more individuals (includes mon- itoring). G0424 ...... Pulmonary rehabilitation, including S 5733 54.55 S 5733 Refer to OPPS exercise (includes monitoring), Addendum B. one hour, per session, up to two sessions per day.
Cardiac Rehabilitation Services
93797 ...... Physician or other qualified health S 5771 $110.22 S 5771 Refer to OPPS care professional services for Addendum B. outpatient cardiac rehabilitation; without continuous ecg moni- toring (per session). 93798 ...... Physician or other qualified health S 5771 110.22 S 5771 Refer to OPPS care professional services for Addendum B. outpatient cardiac rehabilitation; with continuous ecg monitoring (per session). G0422 ...... Intensive cardiac rehabilitation; S 5771 110.22 S 5771 Refer to OPPS with or without continuous ecg Addendum B. monitoring with exercise, per session. G0423 ...... Intensive cardiac rehabilitation; S 5771 110.22 S 5771 Refer to OPPS with or without continuous ecg Addendum B. monitoring; without exercise, per session.
21. Radiology and Imaging Procedures 70392). The purpose of this Specifically, we evaluated the resource and Services restructuring was to more appropriately costs and clinical coherence of the a. Imaging APCs reflect the resource costs and clinical procedures associated with the four characteristics of the services classified levels of imaging without contrast APCs Section 1833(t)(9)(A) of the Act within the imaging APCs. The and the three levels of imaging with requires the Secretary to review not less restructuring of the imaging APCs contrast APCs, as well as identified and often than annually, and revise the APC resulted in broader groupings that corrected any 2 times rule violations as group assignments, relative payment removed the excessive granularity of discussed in section III.B.2. of the CY weights, and the wage and other grouping imaging services according to 2018 OPPS/ASC proposed rule. In adjustments to take into account organ or physiologic system, which did addition, we reviewed and considered changes in medical practice, changes in not necessarily reflect either significant stakeholder recommendations to make technology, the addition of new differences in resources or how these additional refinements to the structure services, new cost data, and other services are delivered in the hospital of the APC groupings of the imaging relevant information and factors. In outpatient setting. In CY 2017, in procedures classified within the addition, section 1833(t)(2)(G) of the Act response to public comments on the CY imaging APCs that would maintain requires the Secretary to create 2017 OPPS/ASC proposed rule, we clinical homogeneity while more additional groups of covered OPD further consolidated the imaging APCs appropriately addressing resource cost services that classify separately those from 17 APCs in CY 2016 to 7 APCs in fluctuation and volatility. As a result of procedures that utilize contrast agents CY 2017 (81 FR 79633). These included our analysis and review of the claims from those procedures that do not four imaging APCs without contrast and data used for CY 2018 ratesetting, we utilize contrast agents. three imaging APCs with contrast. stated in the proposed rule that we In CY 2016, as a part of our As discussed in the CY 2018 OPPS/ believed a Level 5 Imaging without comprehensive review of the structure ASC proposed rule (82 FR 33608), for Contrast APC was needed to more of the APCs and procedure code CY 2018, we reviewed the services appropriately group certain imaging assignments, we restructured the APCs assigned to the imaging without contrast services with higher resource costs. that contain imaging services (80 FR APCs and imaging with contrast APCs. Specifically, we stated our belief that
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the data supported splitting the current commenters suggested that maintaining • CPT code 70553 (Magnetic (CY 2017) Level 4 Imaging without the CY 2017 APC groupings and resonance imaging, brain (including Contrast APC into two APCs such that payment rates, to the extent possible, brain stem); without contrast material, the Level 4 Imaging without Contrast would address their concerns. followed by contrast material(s) and APC would include high frequency, Response: We appreciate these further sequences); low-cost services and the proposed comments and recommendations on • CPT code 71552 (Magnetic Level 5 Imaging without Contrast APC how to structure and assign HCPCS resonance imaging, chest; without would include low frequency high-cost codes to the Imaging without Contrast contrast material(s), followed by services. Therefore, for CY 2018, we APC series. We analyzed the various contrast material(s) and further proposed to add a fifth level within the alternative suggestions for the various sequences); Imaging without Contrast APCs. In recommended HCPCS code placements, • CPT code 72156 (Magnetic Table 19 of the proposed rule, we listed including maintaining the CY 2017 APC resonance imaging, spinal canal and the CY 2017 imaging APCs, and in Table groupings. After consideration of the contents, without contrast material, 20 of the proposed rule, we listed the public comments and suggestions we followed by contrast material(s) and proposed CY 2018 imaging APCs with received, we are not finalizing our further sequences; cervical); the addition of a fifth level within the proposal to add a fifth level to the • CPT code 72157 (Magnetic Imaging without Contrast APCs. The Imaging without Contrast APC series. resonance imaging spinal canal and specific APC assignments for each Instead, we are maintaining the CY 2017 contents, without contrast material, service grouping were listed in APC structure of four levels of Imaging followed by contrast material(s) and Addendum B to the proposed rule, Without Contrast APCs and making further sequences; thoracic); which is available via the Internet on minor reassignments to the HCPCS • CPT code 72158 (Magnetic the CMS Web site. We stated that this codes within this series to resolve or resonance imaging spinal canal and proposal would increase the imaging mitigate any violations of the 2 times contents, without contrast material, APCs from 7 APCs in CY 2017 to 8 in rule or both. We understand the followed by contrast material(s) and CY 2018. The specific APC assignments importance of payment stability for further sequences; lumbar); for each imaging service HCPCS code providers and believe that continuation • CPT code 72197 (Magnetic were listed in Addendum B to the of the four levels of Imaging without resonance imaging pelvis; without proposed rule, which is available via the Contrast APCs would minimize contrast material(s), followed by Internet on the CMS Web site. We noted fluctuation in payment rates from CY contrast material(s) and further that some of the imaging procedures are 2017 to CY 2018. As displayed in the ‘‘2 sequences); assigned to APCs that are not listed in Times Rule’’ for this final rule with • CPT code 73223 (Magnetic the tables (for example, the vascular comment period, which is available via resonance imaging, any joint of upper procedures APCs). Also, the nuclear the Internet on the CMS Web site, the extremity; without contrast material(s), medicine services APCs were not APC geometric mean costs for APCs followed by contrast material(s) and included in this proposal. These 5521 through 5524 are consistent with further sequences); and imaging services were not included in the CY 2017 APC geometric mean costs • CPT code 74183 (Magnetic this proposal because we did not for the same APCs, indicating the cost- resonance imaging abdomen; without propose changes to their APC structure. based relative weights that are used to We invited public comments on our contrast material(s), followed by with calculate payment are stable. proposal to add a Level 5 Imaging contrast material(s) and further without Contrast APC in CY 2018. Comment: A few commenters sequences). Comment: Commenters generally objected to the proposed exception to Response: We were persuaded by the disagreed with CMS’ proposal to add a the violation of the 2 times rule for APC points raised by the commenters and fifth level within the Imaging without 5573 (Level 3 Imaging With Contrast) agree that continuation of the CY 2017 Contrast APC series. These commenters and recommended alternative groupings is appropriate to maintain represented various imaging specialty approaches to resolving the violation, payment stability for imaging services societies and individual practitioners such as the creation of a Level 4 Imaging assigned to APC 5572 and APC 5573. who utilize various imaging modalities. With Contrast or maintaining the CY Although the proposed grouping for Many of the commenters opposed 2017 APC groupings. Commenters APC 5573 achieved clinical similarity, adding a fifth level because of the stated that the proposed reassignment of based on analysis of the claims data proposed resultant reduction in nine high-volume contrast magnetic used for this final rule with comment payment to several vascular ultrasound resonance imaging (MRI) procedures period, we believe we should take a procedures. The commenters urged from Level 2 (CY 2017 placement) to deliberate approach to maintain CMS to not finalize the proposal Level 3 (proposed CY 2018 placement) consistency in payment assignment by because it would destabilize and would result in a significant reduction not adopting the proposals to reassign drastically decrease payments for and underpayment for contrast the nine high-volume contrast MRI certain imaging services compared to echocardiography procedures and procedures from APC 5572 to APC 5573 CY 2017 rates. The commenters noted would significantly lower the payment and to allow for an exception for APC that the proposed rate for certain rate for contrast echocardiography 5573 from the 2 times rule. Therefore, imaging services would cause certain procedures, which has been relatively we are modifying our proposed providers to no longer be able to furnish stable for the past several years, grouping for APC 5573 by moving the these services, thereby impeding access consistent with the procedure costs. nine high-volume contrast MRI to these important services for Medicare These nine high-volume contrast MRI procedures from Level 3 (Imaging with beneficiaries. However, some procedures are described by the Contrast) to Level 2 (Imaging with commenters recommended various following CPT codes: Contrast), which is consistent with their alternative HCPCS code placements • CPT code 70543 (Magnetic CY 2017 APC assignment. In addition, within the Imaging without Contrast resonance imaging, orbit, face, and/or we are making a few other code APC series if CMS finalized its proposal neck; without contrast material(s) and reassignments to resolve the 2 times rule to add a fifth level. Some of these same further sequences); violation in APC 5573.
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In summary, after consideration of the 5 (Imaging without Contrast) APC or the Table 54 below compares the CY 2017 public comments we received and for proposal to assign nine high-volume and 2018 APC geometric mean costs for the reasons discussed above, we are not contrast MRI procedures to Level 3 the imaging APCs. finalizing the proposal to create a Level (Imaging with Contrast) for CY 2018.
TABLE 54—COMPARISON OF CY 2017 AND CY 2018 GEOMETRIC MEAN COSTS FOR THE IMAGING APCS
CY 2017 APC CY 2018 APC APC APC group title geometric geometric mean cost mean cost
5521 ...... Level 1 Imaging without Contrast ...... $61.53 $62.08 5522 ...... Level 2 Imaging without Contrast ...... 115.88 118.68 5523 ...... Level 3 Imaging without Contrast ...... 232.21 245.08 5524 ...... Level 4 Imaging without Contrast ...... 462.23 486.38 5571 ...... Level 1 Imaging with Contrast ...... 272.40 252.58 5572 ...... Level 2 Imaging with Contrast ...... 438.42 456.08 5573 ...... Level 3 Imaging with Contrast ...... 675.23 681.45
The specific APC assignments for 2013 OPPS/ASC final rule with commenters noted that status indicator each imaging procedure grouping are comment period (77 FR 68345 through ‘‘Q2’’ indicates that payment for the listed in Addendum B to this final rule 68346), the CY 2014 OPPS/ASC final procedure described by HCPCS code with comment period, which is rule with comment period (78 FR 74976 C9733 is conditionally packaged when available via the Internet on the CMS through 74977), and the CY 2017 OPPS/ provided in conjunction with other Web site. ASC final rule with comment period (81 procedures assigned to status indicator FR 79632), the service described by ‘‘T,’’ which are primarily surgical b. Non-Ophthalmic Fluorescent HCPCS code C9733 is primarily an procedures. Vascular Angiography (APC 5523) intraoperative imaging service that is Response: Regarding the status As discussed in the CY 2018 OPPS/ performed in combination with a indicator assignment of HCPCS code ASC proposed rule (82 FR 33609), for number of primary procedures, C9733, we have addressed this comment the CY 2018 OPPS update, we proposed including facial reconstruction and in prior rules (81 FR 79632). The service to reassign HCPCS code C9733 (Non- reanimation, muscle flaps, trauma described by HCPCS code C9733 is ophthalmic fluorescent vascular reconstruction, digital and limb primarily an intraoperative imaging angiography) from APC 5523 (Level 3 reattachment, and breast reconstruction. service. Therefore, payment for the Imaging without Contrast) to APC 5524 Therefore, payment for the service service is conditionally packaged under (Level 4 Imaging without Contrast) described by HCPCS code C9733 is § 419.2(b)(14), which packages based on the latest claims data available conditionally packaged under 42 CFR intraoperative items and services. When for the proposed rule. We proposed to 419.2(b)(14), which contains the the procedure described by HCPCS code maintain the status indicator assignment policies governing packaging of C9733 is not furnished in conjunction of ‘‘Q2’’ (T-packaged) to indicate that intraoperative items and services. with a surgical procedure, the service is the service is conditionally packaged Consequently, we proposed to maintain paid separately. We believe that the when performed in conjunction with the status indicator assignment of ‘‘Q2’’ OPPS payments, separate or packaged, other procedures on the same day but to indicate that the payment for the for surgical procedures with which this paid separately when performed as a service will be packaged in the APC test is performed (for example, breast stand-alone service. payment if billed on the same date of reconstruction) are more than adequate Our claims data used for the proposed service as a HCPCS code assigned to to cover the cost of the service described rule, which included claims submitted status indicator ‘‘T’’, but in all other by HCPCS code C9733 for Medicare between January 1, 2016, and December circumstances, a separate APC payment beneficiaries in need of this service. 31, 2016, and processed on or before for the service will be made. We believe With respect to the APC reassignment December 31, 2016, showed a geometric that the OPPS payments, separate or for APC 5524, because we are mean cost of approximately $236 for packaged, for surgical procedures with maintaining the CY 2017 APC group HCPCS code C9733 based on 216 single which this service is performed are assignments for imaging services, we are claims (out of 953 total claims), which more than adequate to cover the cost of not finalizing our proposal to reassign is closely aligned with the geometric the service described by HCPCS code HCPCS code C9733 from APC 5523 to mean cost of approximately $275 for C9733 for Medicare beneficiaries in APC 5524. Rather, we are maintaining APC 5524. Because HCPCS code C9733 need of this service. the assignment of the procedure is an imaging service which is similar to Comment: Several commenters described by HCPCS code C9733 to APC the codes assigned to APC 5524, we supported the proposed APC 5523 for CY 2018. Based on our review proposed to reassign HCPCS code C9733 reassignment for HCPCS code C9733 to of the CY 2018 final rule claims data, from APC 5523 to APC 5524. We stated APC 5524. A few commenters also the procedure described by HCPCS code that we believe this proposed suggested assignment of HCPCS code C9733 has a geometric mean unit cost of reassignment would improve the C9733 in a higher payment APC approximately $237 and the geometric clinical homogeneity of APC 5524 and (compared to the CY 2017 payment rate) mean cost of APC 5523 is approximately appropriately align the resource costs of that would cover the cost of the service, $245 for CY 2018. Therefore, it is not HCPCS code C9733 to the resource costs but did not recommend a specific APC. necessary to reassign the procedure of those procedures assigned to APC In addition, commenters requested that described by HCPCS code C9733 to APC 5524. CMS change the status indicator 5524, which has a geometric mean unit As we have stated in previous OPPS/ assignment from ‘‘Q2’’ to a separately cost of about $486. It is more ASC final rules, specifically, in the CY payable status indicator ‘‘S’’. The appropriate to maintain the assignment
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of the procedure described by HCPCS describe the injection of a accurately describe the complete code C9733 to APC 5523 because of the noncompounded foam sclerosant for procedure, service, or item described of similarity in clinical characteristics and treatment of incompetent veins. Table the CPT code. Therefore, we included resource use for this procedure and 55 below lists the complete descriptors the 5-digit placeholder codes and their other imaging procedures assigned to for the new CPT codes. These codes long descriptors in Addendum O to the APC 5523. were listed in Addendum B and proposed rule, specifically under the After consideration of the public Addendum O to the CY 2018 OPPS/ASC column labeled ‘‘CY 2018 OPPS/ASC comments we received, we are not proposed rule (which are available via Proposed Rule 5-Digit AMA Placeholder finalizing our proposal to reassign the Internet on the CMS Web site). Code’’ so that the public could HCPCS code C9733 from APC 5523 to Addendum B listed the proposed status adequately comment on our proposed APC 5524 for CY 2018. Instead, for CY indicator assignments for the new codes APC and status indicator assignments. 2018, we are continuing to assign and assigned them to comment We also indicated that the final CPT HCPCS code C9733 to APC 5523 and indicator ‘‘NP’’ (New code for the next code numbers would be included in this continuing to assign the code to status calendar year or existing code with CY 2018 OPPS/ASC final rule with indicator ‘‘Q2’’ to indicate that the substantial revision to its code comment period. The final CPT code service is conditionally packaged. The descriptor in the next calendar year as numbers, along with their compared to current calendar year, final CY 2018 OPPS payment rate for corresponding 5-digit placeholder proposed APC assignment; comments HCPCS code C9733 can be found in codes, can be found in Table 55 below. OPPS Addendum B to this final rule will be accepted on the proposed APC with comment period, which is assignment for the new code), while As displayed in Table 55 below and available via the Internet on the CMS Addendum O listed the proposed/ in Addendum B of the CY 2018 OPPS/ Web site. placeholder CY 2018 CPT codes and the ASC proposed rule, we proposed to long descriptors. We note that the CPT assign CPT codes 36465 and 36466 to 22. Sclerotherapy (APC 5054) code descriptors that appeared in APC 5053 (Level 3 Skin Procedures), For CY 2018, the AMA CPT Editorial Addendum B to the CY 2018 proposed with a proposed payment rate of Panel established two new codes to rule were short descriptors and did not $468.82.
TABLE 55—PROPOSED CY 2018 STATUS INDICATOR (SI), APC ASSIGNMENT, AND PAYMENT RATES FOR CPT CODES 36465 AND 36466
CY 2018 Proposed OPPS/ASC Proposed Proposed CY 2018 CPT code proposed rule Long descriptor CY 2018 CY 2018 OPPS placeholder OPPS SI OPPS APC payment code rate
36465 ...... 364X5 ...... Injection of non-compounded foam sclerosant with ultrasound T 5053 $468.82 compression maneuvers to guide dispersion of the injectate, in- clusive of all imaging guidance and monitoring; single incom- petent extremity truncal vein (e.g., great saphenous vein, ac- cessory saphenous vein). 36466 ...... 364X6 ...... Injection of non-compounded foam sclerosant with ultrasound T 5053 468.82 compression maneuvers to guide dispersion of the injectate, in- clusive of all imaging guidance and monitoring; multiple incom- petent truncal veins (e.g., great saphenous vein, accessory sa- phenous vein), same leg.
Comment: Several commenters not comparable to the procedures through separate access sites (list opposed the proposed assignment of described by new CPT codes 36465 and separately in addition to code for new CPT codes 36465 and 36466 to APC 36466 based on complexity, staff type, primary procedure)); 5053 and requested the assignment to staff time, and use of ultrasound • CPT code 36475 (Endovenous APC 5183 (Level 3 Vascular guidance. The commenters further ablation therapy of incompetent vein, Procedures), which had a proposed added that the two procedures are most extremity, inclusive of all imaging payment rate of $2,409.72. The similar to the endovenous ablative guidance and monitoring, percutaneous, commenters stated that CMS procedures that treat incompetent veins radiofrequency; first vein treated); inappropriately proposed to assign these in APC 5183, specifically, the • CPT code 36476 (Endovenous codes to APC 5053 based on a procedures described by the following ablation therapy of incompetent vein, comparison to CPT codes 36470 CPT codes: extremity, inclusive of all imaging (Injection of sclerosing solution; single • CPT code 36473 (Endovenous guidance and monitoring, percutaneous, vein) and 36471 (Injection of sclerosing ablation therapy of incompetent vein, radiofrequency; subsequent vein(s) solution; multiple veins, same leg). extremity, inclusive of all imaging treated in a single extremity, each However, the commenters indicated that guidance and monitoring, percutaneous, through separate access sites (list CPT codes 36465 and 36466 are mechanochemical; first vein treated); separately in addition to code for dissimilar to the procedures assigned to • CPT code 36474 (Endovenous primary procedure)) APC 5053, which describe simple skin ablation therapy of incompetent vein, • CPT code 36478 (Endovenous procedures (for example, debridement, extremity, inclusive of all imaging ablation therapy of incompetent vein, Moh’s surgery, and skin lesion guidance and monitoring, percutaneous, extremity, inclusive of all imaging destruction). They stated that the mechanochemical; subsequent vein(s) guidance and monitoring, percutaneous, procedures assigned to APC 5053 are treated in a single extremity, each laser; first vein treated); and
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• CPT code 36479 (Endovenous practice expense input price of $1,054 of the Act, we will reevaluate the APC ablation therapy of incompetent vein, for the Varithena (foam) used in the assignment for CPT codes 36465 and extremity, inclusive of all imaging procedures. 36466 in the next rulemaking cycle. Response: Because CPT codes 36465 guidance and monitoring, percutaneous, In summary, after consideration of the laser; subsequent vein(s) treated in a and 36466 are new codes for CY 2018, public comments we received, we are single extremity, each through separate we have no claims data on which to finalizing our proposal for the APC access sites (list separately in addition base our payment rate. However, in the to code for primary procedure)). absence of claims data, we reviewed the assignment of the procedures described One commenter stated that the clinical characteristics of the procedures by new CPT codes 36465 and 36466, procedures described by CPT codes to determine whether they are similar to with modification. Specifically, we are 36465 and 36466 share similar existing procedures. After reviewing assigning both codes to APC 5054, characteristics and comparable information from the public instead of proposed APC 5053, for CY anticipated costs as the procedures commenters and input from our clinical 2018. Table 56 below lists the final assigned to APC 5183, and advisors, we believe that new CPT codes status indicator and APC assignments consequently, requested an assignment 36465 and 36466 are clinically similar for CPT codes 36465 and 36466 for CY to APC 5183 for the two new CPT codes. to those procedures assigned to APC 2018. We refer readers to Addendum B Another commenter noted that CPT 5053. However, in light of the to this final rule with comment period codes 36473, 36475, and 36478 are commenter’s reported supply expense of for the payment rates for all codes currently assigned to APC 5183, and $1,054 for the Varithena (foam), we reported under the OPPS. In addition, requested that CMS also assign new CPT believe that an assignment to APC 5054 we refer readers to Addendum A to this codes 36465 and 36466 to APC 5183. is necessary. We note that the final CY final rule with comment period for the One commenter reported that, in the CY 2018 geometric mean cost for APC 5054 status indicator meanings for all codes 2018 MPFS proposed rule, CMS is approximately $1,567. Therefore, we reported under the OPPS. Both proposed a nonfacility payment of believe that APC 5054 is a more Addendum A and Addendum B are $1,605.17 for new CPT code 36465 and appropriate APC assignment for the new available via the Internet on the CMS $1,678.23 for new CPT code 36466 for CPT codes. Consistent with the statutory Web site. CY 2018. This commenter also listed a requirement under section 1833(t)(9)(A)
TABLE 56—FINAL CY 2018 STATUS INDICATOR (SI) AND APC ASSIGNMENT FOR CPT CODES 36465 AND 36466
CY 2018 OPPS/ASC Proposed Proposed CPT code proposed rule Long descriptor CY 2018 CY 2018 CY 2018 OPPS placeholder OPPS SI OPPS APC payment rate code
36465 ...... 364X5 ...... Injection of non-compounded foam sclerosant with ultrasound T 5054 Refer to OPPS compression maneuvers to guide dispersion of the Addendum B. injectate, inclusive of all imaging guidance and monitoring; single incompetent extremity truncal vein (e.g., great sa- phenous vein, accessory saphenous vein). 36466 ...... 364X6 ...... Injection of non-compounded foam sclerosant with ultrasound T 5054 Refer to OPPS compression maneuvers to guide dispersion of the Addendum B. injectate, inclusive of all imaging guidance and monitoring; multiple incompetent truncal veins (e.g., great saphenous vein, accessory saphenous vein), same leg.
23. Skin Substitutes (APCs 5053, 5054, Procedures) to APC 5054 (Level 4 Skin that the procedures described by HCPCS and 5055) Procedures) and that CPT code 15277 code C5277 and CPT code 15277 are For CY 2018, we proposed to assign (Application of skin substitute graft to appropriately assigned to APCs 5053 skin substitute procedures to APCs 5053 face, scalp, eyelids, mouth, neck, ears, and 5054, respectively. While the through 5055 (Level 3 through 5 Skin orbits, genitalia, hands, feet, and/or geometric mean cost of the procedure Procedures). The cost of the procedures multiple digits, total wound surface area described by HCPCS code C5277 is affected by whether the skin greater than or equal to 100 sq cm; first ($2,187) is higher than the geometric substitute product is low cost or high 100 sq cm wound surface area, or 1% mean cost of other procedures assigned cost, the surface area of the wound, and of body area of infants and children) be to APC 5053 ($488), there are fewer than the location of the wound. moved from APC 5054 (Level 4 Skin 25 single claims billed for the procedure Comment: Commenters requested that Procedures) to APC 5055 (Level 5 Skin described by HCPCS code C5277. CPT codes for large wounds be assigned Procedures). Another commenter Therefore, HCPCS code C5277 is not a to higher paying APCs. One commenter focused on the payment for large venous significant procedure code and does not 2 asked that HCPCS code C5277 leg ulcers that are over 100 cm . This create a 2 times rule violation in APC (Application of low cost skin substitute commenter requested that the skin 5053. Likewise, while the geometric graft to face, scalp, eyelids, mouth, neck, substitute procedures used to treat large mean cost of the procedure described by ears, orbits, genitalia, hands, feet, and/ venous leg ulcers and other large CPT code 15277 ($2,464) is higher than or multiple digits, total wound surface wounds be moved to a higher paying the geometric mean cost for all area greater than or equal to 100 sq cm; APC. procedures assigned to APC 5054 first 100 sq cm wound surface area, or Response: We reviewed the ($1,567), there are fewer than 80 single 1% of body area of infants and children) procedures assigned to both APC 5053 claims billed for the procedure be moved from APC 5053 (Level 3 Skin and APC 5054 and continue to believe described by CPT code 15277.
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Therefore, CPT code 15277 is not a 24. Subdermal Drug Implants for the • Placeholder HCPCS code GDDD3 significant procedure and does not Treatment of Opioid Addiction (APC (Removal with reinsertion, non- create a 2 times violation in APC 5054. 5735) biodegradable drug delivery implants, 4 Accordingly, we continue to believe that In the CY 2018 MPFS proposed rule or more). both HCPCS code C5277 and CPT code (82 FR 34011 through 34012), CMS We did not make any proposal related 15277 are appropriately assigned to proposed to establish three G-codes to to HCPCS codes GDDD1 through APCs 5053 and 5054, respectively. As appropriately report the insertion and GDDD3 in the CY 2018 OPPS/ASC we do every year, we will evaluate the removal of buprenorphine proposed rule because there are existing costs and APC assignment of both of hydrochloride, formulated as a 4-rod, 80 codes that can be used to report the these codes in the next annual mg, long-acting subdermal drug implant insertion and removal of buprenorphine rulemaking cycle. for the treatment of opioid addiction (82 hydrochloride, as well as a HCPCS J- FR 34011 through 34012). Specifically, After consideration of the public code to report use of the buprenorphine we proposed to establish the following comments we received, we are hydrochloride drug. Listed below in HCPCS G-codes: finalizing our proposal for CY 2018 for • Placeholder HCPCS Code GDDD1 Table 57 are the specific CPT and assignment of skin substitute (Insertion, non-biodegradable drug HCPCS codes for the buprenorphine procedures to APCs 5053 through 5055, delivery implants, 4 or more); hydrochloride subdermal drug and its including the assignment of HCPCS • Placeholder HCPCS Code GDDD2 administration, and the proposed OPPS code C5277 to APC 5053 and CPT code (Removal, non-biodegradable drug payment rates for CY 2018. 15277 to APC 5054. delivery implants, 4 or more); and
TABLE 57—PROPOSED CY 2018 STATUS INDICATOR (SI), APC ASSIGNMENT, AND PAYMENT RATE FOR CPT CODES 11981, 11982, AND 11983 AND HCPCS CODE J0570
Proposed CY 2017 Proposed Proposed CY 2018 HCPCS code Long descriptor CY 2017 CY 2017 OPPS CY 2018 CY 2018 OPPS OPPS SI OPPS APC payment OPPS SI OPPS APC payment rate rate
11981 ...... Insertion, non-biodegradable drug de- Q1 5734 $100.02 Q1 5734 $94.27 livery implant. 11982 ...... Removal, non-biodegradable drug de- Q1 5735 263.61 Q1 5735 265.20 livery implant. 11983 ...... Removal with reinsertion, non-bio- Q1 5735 263.61 Q1 5735 265.20 degradable drug delivery implant. J0570 ...... Buprenorphine implant, 74.2 mg ...... G 9058 * 1,260.59 G 9058 ** 1,261.31 * The proposed payment rate of $1,260.59 was based on the April 1, 2017 OPPS update. ** The payment rate of $1,261.31 was based on the October 1, 2017 OPPS update. Payments for the HCPCS drug codes are updated on a quarterly basis, and this payment rate will be updated for the January 2018 OPPS update. Refer to the January 2018 OPPS Addendum B pay- ment file for the payment rate.
Comment: Some commenters hydrochloride can be performed in the G0516, G0517, G0518, and HCPCS code requested that the MPFS proposal for hospital outpatient department. J0570 for CY 2018. We remind hospitals establishment of HCPCS G-codes for However, because these services are that the HCPCS drug code for insertion and removal of buprenorphine conditionally packaged under the OPPS, buprenorphine hydrochloride (HCPCS hydrochloride also apply to the OPPS they will be packaged when performed code J0570) should also be reported and ASC payment systems. In addition, in the ASC and, therefore, not separately when billing for the subdermal the commenters recommended that paid. Accordingly, to adequately track administration of the drug. We refer CMS assign the HCPCS G-codes to APC and improve data collection and readers to Addendum B to this final rule 5735 (Level 5 Minor Procedures), which analysis associated with subdermal with comment period for the payment had a proposed payment rate of $265.20, buprenorphine implants, we are rates for all codes reported under the for CY 2018. recognizing these HCPCS G-codes in the OPPS. In addition, we refer readers to Response: We agree with the OPPS. commenters that the HCPCS G-codes In summary, after consideration of the Addendum A to this final rule with GDDD1 through GDDD3 (now HCPCS public comments we received, we are comment period for the status indicator codes G0516, G0517, and G0518 in this establishing HCPCS G-codes G0516, meanings for all codes reported under final rule with comment period) should G0517, and G0518 under the OPPS, the OPPS. Both Addendum A and also be recognized under the OPPS effective January 1, 2018. Table 58 Addendum B are available via the because the service associated with the below lists the final status indicator and Internet on the CMS Web site. insertion and removal of buprenorphine APC assignments for HCPCS G-codes
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TABLE 58—FINAL CY 2018 STATUS INDICATOR (SI) AND APC ASSIGNMENT FOR HCPCS CODES G0516, G0517, G0518 AND HCPCS CODE J0570
CY 2018 MPFS HCPCS code proposed rule Long descriptor CY 2018 CY 2018 CY 2018 OPPS placeholder OPPS SI OPPS APC payment rate code
G0516 ...... GDDD1 ...... Insertion of non-biodegradable drug delivery implants, 4 or Q1 5735 Refer to OPPS more (services for subdermal implants). Addendum B. G0517 ...... GDDD2 ...... Removal of non-biodegradable drug delivery implants, 4 or Q1 5735 Refer to OPPS more (services for subdermal implants). Addendum B. G0518 ...... GDDD3 ...... Removal with reinsertion, non-biodegradable drug delivery Q1 5735 Refer to OPPS implants, 4 or more (services for subdermal implants). Addendum B. J0570 ...... N/A ...... Buprenorphine implant, 74.2 mg ...... G 9058 Refer to OPPS Addendum B.
25. Suprachoroidal Delivery of APC 5694 (Level 4 Drug (Procedure or Service, Not Discounted Pharmacologic Agent (APC 5694) Administration), with a proposed When Multiple) and to continue to For CY 2018, as noted in Table 59 payment rate of $286.62. We also assign CPT code 0465T to status below, we proposed to continue to proposed to continue to assign CPT indicator ‘‘T’’ (Procedure or Service, assign CPT codes 67028 and 0465T to code 67028 to status indicator ‘‘S’’ Multiple Procedure Reduction Applies).
TABLE 59—PROPOSED CY 2018 STATUS INDICATOR (SI), APC ASSIGNMENT, AND PAYMENT RATE FOR CPT CODES 67028 AND 0465T
Proposed CY 2017 Proposed Proposed CY 2018 CPT code Long descriptors CY 2017 CY 2017 OPPS CY 2018 CY 2018 OPPS OPPS SI OPPS APC payment OPPS SI OPPS APC payment rate rate
67028 ...... Intravitreal injection of a pharmaco- S 5694 $279.45 S 5694 $286.62 logic agent (separate procedure). 0465T ...... Suprachoroidal injection of a pharma- T 5694 279.45 T 5694 286.62 cologic agent (does not include sup- ply of medication).
Comment: Some commenters stated OPPS, while status indicator ‘‘S’’ by itself or with a visit, or with a service that the different status indicator describes a procedure or service that is or procedure assigned to status indicator assignment for both CPT codes 67028 not discounted. Within APC 5694, there ‘‘S’’, the multiple procedure reduction and 0465T appears to be an error and are four CPT codes that are assigned to will not apply. We remind hospitals contradicts CMS’ decision in the CY status indicator ‘‘T’’. These include the that, when reporting CPT code 0465T, 2017 OPPS/ASC final rule with following procedures: the appropriate HCPCS drug code comment period where CMS indicated • CPT code 0465T (Suprachoroidal should also be reported on the claim. that both procedures are similar from a injection of a pharmacologic agent (does Therefore, after consideration of the clinical and resource consideration (81 not include supply of medication)); public comments we received, we are FR 79617). The commenters reported • CPT code 36593 (Declotting by that the different status indicators thrombolytic agent of implanted finalizing our CY 2018 proposal, suggest that the procedures are not vascular access device or catheter); without modification, to continue to similar. Consequently, the commenters • CPT code 37195 (Thrombolysis, assign CPT codes 67028 and 0465T to requested the reassignment of CPT code cerebral, by intravenous infusion); and status indicator ‘‘S’’ and ‘‘T’’ 0465T from status indicator ‘‘T’’ to ‘‘S’’. • CPT code 92977 (Thrombolysis, respectively, and to continue to assign Response: We note that while many coronary; by intravenous infusion). the CPT codes to APC 5694. Table 60 HCPCS codes within a given APC may As stated earlier, status indicator ‘‘T’’ below lists the final status indicator and have the same status indicator, having indicates that the service will be APC assignments for both codes for CY an identical status indicator is not a reduced by 50 percent if it is the lower 2018. We refer readers to Addendum B prerequisite for APC assignment. That priced service on the same claim with to this final rule with comment period is, assignment of a HCPCS code to an another procedure that is also assigned for the payment rates for all codes APC is based on the resource and to a status indicator ‘‘T’’. For CPT code reported under the OPPS. In addition, clinical similarity of the service 0465T, we expect this reduction to we refer readers to Addendum A to this described by the HCPCS code, while occur when there is a separate final rule with comment period for the assignment of a status indicator is based procedure performed on the same day as status indicator meanings for all codes on service-specific characteristics. the suprachoroidal injection due to reported under the OPPS. Both Status indicator ‘‘T’’ is used to denote significant efficiencies in administering Addendum A and Addendum B are that the procedure is subject to the the pharmacologic agent. If the available via the Internet on the CMS multiple procedure reduction under the suprachoroidal injection is performed Web site.
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TABLE 60—FINAL CY 2018 STATUS INDICATOR (SI) AND APC ASSIGNMENT FOR CPT CODES 67028 AND 0465T
CY 2017 CY 2017 CY 2017 OPPS CY 2018 CY 2018 CY 2018 OPPS HCPCS code Long descriptor OPPS SI OPPS APC payment OPPS SI OPPS APC payment rate rate
67028 ...... Intravitreal injection of a pharma- S 5694 $279.45 S 5694 Refer to OPPS cologic agent (separate proce- Addendum B. dure). 0465T ...... Suprachoroidal injection of a T 5694 279.45 T 5694 Refer to OPPS pharmacologic agent (does not Addendum B. include supply of medication).
26. Transperineal Placement of with or without image guidance (not to Addendum B listed the proposed status Biodegradeable Material (C–APC 5375) be used if a more specific code applies)), indicator assignment for the which was effective October 1, 2015 and replacement code and assigned it to For CY 2018, the AMA CPT Editorial was deleted on June 30, 2016, when it comment indicator ‘‘NP’’ (New code for Panel deleted CPT code 0438T and was replaced with CPT code 0438T, the next calendar year or existing code replaced the code with CPT code 55874, effective July 1, 2016. with substantial revision to its code effective January 1, 2018. CPT code Table 61 below lists the complete descriptor in the next calendar year as 0438T was effective July 1, 2016 and descriptors for the deleted and compared to current calendar year, will be deleted on December 31, 2017. replacement CPT codes. We note that proposed APC assignment; comments Prior to July 2016, the transperineal the deleted and replacement CPT codes will be accepted on the proposed APC placement of biodegradable material were both listed in Addendum B and assignment for the new code), while procedure was described by HCPCS Addendum O to the CY 2018 OPPS/ASC Addendum O listed the proposed/ code C9743 (Injection/implantation of proposed rule (which are available via placeholder CY 2018 CPT codes and the bulking or spacer material (any type) the Internet on the CMs Web site). long descriptors.
TABLE 61—CODING CHANGES FOR CPT CODE 55874
CY 2018 OPPS/ASC CPT code proposed rule Long descriptor placeholder code
0438T ...... N/A ...... Transperineal placement of biodegradable material, peri-prostatic (via needle), single or multiple, includes image guidance. 55874 ...... 55X87 ...... Transperineal placement of biodegradable material, peri-prostatic, single or multiple injection(s), including image guidance, when performed.
As listed in Table 63 below and in to revise the APC assignment for CPT claims), which is similar to the Addendum B of the CY 2018 OPPS/ASC code 55874 based on claims data used geometric mean cost of approximately proposed rule, we proposed to delete for the CY 2018 OPPS/ASC proposed $3,742 for C–APC 5375 rather than the CPT code 0438T (status indicator ‘‘D’’) rule. We note that the proposed rule geometric mean cost of approximately and assign its replacement code, CPT claims data was based on claims data $2,714 for C–APC 5374 or the geometric code 55874 (placeholder code 55X87), submitted between January 1, 2016, and mean cost of approximately $7,747 for to C–APC 5375 (Level 5 Urology and December 31, 2016, that were processed C–APC 5376 (Level 6 Urology and Related Services) with a proposed on or before December 31, 2016. For the Related Services). Based on its clinical payment rate of $3,597.65. As noted in predecessor codes HCPCS codes C9743 homogeneity and resource similarity to Table 62, the predecessor code 0438T and 0438T that were in effect during CY the other procedures assigned to C–APC was assigned to C–APC 5374 (Level 4 2016, our analysis of the proposed rule 5375, we proposed to reassign Urology and Related Services), while claims data revealed a geometric mean replacement CPT code 55874 from C– this replacement code is proposed to be cost of approximately $4,504 based on reassigned to C–APC 5375. We proposed 157 single claims (out of 159 total APC 5374 to C–APC 5375 for CY 2018. TABLE 62—PROPOSED CY 2018 STATUS INDICATOR (SI), APC ASSIGNMENT, AND PAYMENT RATE FOR CPT CODE 55874
CY 2018 Proposed OPPS/ASC CY 2017 CY 2017 Proposed Proposed CY 2018 CPT code proposed rule Short descriptor CY 2017 OPPS OPPS CY 2018 CY 2018 OPPS placeholder OPPS SI APC payment OPPS SI OPPS payment code rate APC rate
0438T ...... Tprnl plmt biodegrdabl matrl ...... T 5374 $2,542.56 D N/A N/A 55874 ...... 55X87 ...... Tprnl plmt biodegrdabl matrl ...... N/A N/A N/A T 5375 $3,597.65
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Comment: One commenter supported of the final rule claims data shows a because it does not meet the criteria of the reassignment to C–APC 5375 for similar pattern for the predecessor a device offset that is greater than 40 CPT code 55874 and urged CMS to codes. Specifically, we found a percent. For more information on how finalize the proposal. The commenter geometric mean cost of approximately codes are designated as device-intensive further indicated that C–APC 5375 is the $4,452 for the predecessor codes based status, we refer readers to section IV.B. appropriate APC assignment for CPT on 157 single claims (out of 160 total of this final rule with comment period. code 55874 based on its clinical and claims), which is similar to the In summary, after consideration of the resource coherence to the other geometric mean cost of approximately public comments we received and our procedures assigned to C–APC 5375. $3,704 for C–APC 5375. In addition, our analysis of the updated claims data for While supportive of the assignment to analysis of the significant procedures C–APC 5375, this same commenter within C–APC 5375 shows that the this final rule with comment period, we expressed concern with the payment for geometric mean cost of $4,452 for the are finalizing our CY 2018 proposal, the procedure under the ASC payment predecessor codes are similar to the without modification, and assigning system. The commenter suggested that costs of the procedures assigned to C– CPT code 55874 to C–APC 5375. Table CPT code 55874 should be designated as APC 5375. Specifically, our analysis 63 below lists the final status indicator a device-intensive procedure. revealed the range of the significant and APC assignments for CPT code Response: We appreciate the procedures assigned to C–APC 5375 is 55874 for CY 2018. We refer readers to commenter’s support. For this final rule between $3,134 (for CPT code 52320) Addendum B to this final rule with with comment period, we again and $5,004 (for CPT code 55875). comment period for the payment rates reviewed the updated claims data Consequently, we believe that C–APC for all codes reported under the OPPS. associated with predecessor HCPCS 5375 is the most appropriate APC In addition, we refer readers to codes C9743 and 0438T. We note that, assignment for CPT code 55874. Addendum A to this final rule with for this final rule with comment period, With regards to the device-intensive comment period for the status indicator we used claims data with dates of designation for CPT code 55874, based meanings for all codes reported under service between January 1, 2016, and on our analysis of the predecessor the OPPS. Both Addendum A and December 31, 2016, that were processed HCPCS code C9743, this code is not Addendum B are available via the on or before June 30, 2017. Our analysis eligible for device-intensive status Internet on the CMS Web site. TABLE 63—FINAL CY 2018 STATUS INDICATOR (SI) AND APC ASSIGNMENT FOR CPT CODE 55874
CY 2018 OPPS/ASC CY 2017 CY 2017 CY 2018 CPT code proposed rule Short descriptor CY 2017 OPPS OPPS CY 2018 OPPS CY 2018 OPPS placeholder OPPS SI APC payment OPPS SI APC payment rate code rate
0438T ...... Tprnl plmt biodegrdabl matrl ...... T 5374 $2,542.56 D N/A N/A. 55874 ...... 55X87 ...... Tprnl plmt biodegrdabl matrl ...... N/A N/A N/A T 5375 Refer to OPPS Ad- dendum B.
27. Transcranial Magnetic Stimulation assign CPT code 90867 to APC 5722 Diagnostic Tests and Related Services). (TMS) Therapy (APCs 5721 and 5722) (Level 2 Diagnostic Tests and Related However, we proposed to reassign CPT For CY 2018, as listed in Table 64 Services) and to also continue to assign code 90868 from APC 5722 to APC below, we proposed to continue to CPT code 90869 to APC 5721 (Level 1 5721.
TABLE 64—PROPOSED CY 2018 STATUS INDICATOR (SI), APC ASSIGNMENT, AND PAYMENT RATE FOR THE TRANSCRANIAL MAGNETIC STIMULATION (TMS) THERAPY CPT CODES
CY 2017 Proposed CY 2017 CY 2017 OPPS Proposed Proposed CY 2018 CPT code Long descriptor OPPS SI OPPS APC CY 2018 CY 2018 OPPS payment OPPS SI OPPS APC payment rate rate
90867 ...... Therapeutic repetitive transcranial mag- S 5722 $232.31 S 5722 $242.21 netic stimulation (tms) treatment; initial, including cortical mapping, motor thresh- old determination, delivery and manage- ment. 90868 ...... Therapeutic repetitive transcranial mag- S 5722 232.31 S 5721 129.59 netic stimulation (tms) treatment; subse- quent delivery and management, per session. 90869 ...... Therapeutic repetitive transcranial mag- S 5721 127.10 S 5721 129.59 netic stimulation (tms) treatment; subse- quent motor threshold re-determination with delivery and management.
Comment: Several commenters reassign CPT code 90868 to APC 5721 rate does not cover the cost of providing disagreed with CMS’ proposal to and stated that the proposed payment the service. One commenter stated that
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transcranial magnetic stimulation (TMS) claims data showed a geometric mean 90868 and 90869 based on their clinical therapy requires the use of an expensive cost of approximately $119 for CPT code homogeneity and resource costs to the machine, technicians to assist with the 90869 based on 95 single claims (out of other procedures in APC 5721. service, staff to work on insurance 96 total claims), which is similar to the With regards to the comment that approvals, and significant time with geometric mean cost of approximately TMS therapy requires significant time physicians. Another commenter stated $135 for APC 5721. Consequently, we with physicians, we remind readers that that the proposed payment rate for CPT proposed to continue to assign CPT codes 90868 and 90869 is insufficient, code 90869 to APC 5721. payments under the OPPS are for and that the cost of providing the For this final rule with comment services provided by hospital outpatient service exceeds the payment rate. period, we again reviewed the updated facilities, not physician services. We Several commenters requested that CMS claims data associated with CPT codes note that physician services are paid reconsider and increase the payment 90868 and 90869. We note that, for this under the MPFS. Medicare payment rates for CPT codes 90868 and 90869. final rule with comment period, we rates for physician services can be found Response: We proposed to revise the used claims data with dates of service on the CMS Physician Fee Schedule APC assignment for CPT code 90868 between January 1, 2016, and December Web site, specifically at: https:// and to continue the APC assignment for 31, 2016, that were processed on or www.cms.gov/apps/physician-fee- CPT code 90869 based on CY 2016 before June 30, 2017. Our analysis of the schedule/overview.aspx. claims data used for the CY 2018 OPPS/ final rule claims data revealed a similar In summary, after consideration of the ASC proposed rule. We note that the pattern for both codes. Specifically, we public comments we received, we are proposed rule data was based on claims found a geometric mean cost of finalizing our CY 2018 proposal, data submitted between January 1, 2016, approximately $148 for CPT code 90868 without modification, for CPT codes and December 31, 2016, that were based on 7,258 single claims (out of processed on or before December 31, 7,312 total claims), which is similar to 90867, 90868, and 90869. Table 65 2016. For CPT code 90868, our analysis the geometric mean cost of below lists the final status indicator and of the claims data showed a geometric approximately $136 for APC 5721, APC assignments for all three CPT mean cost of approximately $152 for the rather than the geometric mean cost of codes. We refer readers to Addendum B code based on 6,433 single claims (out approximately $249 for APC 5722. Our to this final rule with comment period of 6,493 total claims), which is similar analysis also revealed a geometric mean for the payment rates for all codes to the geometric mean cost of cost of approximately $125 for CPT code reported under the OPPS. In addition, approximately $135 for APC 5721 rather 90869 based on 105 single claims (out we refer readers to Addendum A to this than the geometric mean cost of of 106 total claims), which is final rule with comment period for the approximately $252 for APC 5722. comparable to the geometric mean cost status indicator meanings for all codes Consequently, we proposed to revise the of $136 for APC 5721. Based on our reported under the OPPS. Both APC assignment for CPT code 90868 to analysis of the final rule claims data, we Addendum A and Addendum B are APC 5721 rather than continue to assign believe that APC 5721 is the appropriate available via the Internet on the CMS it to APC 5722. For CPT code 90869, our APC assignment for both CPT codes Web site.
TABLE 65—FINAL CY 2018 STATUS INDICATOR (SI) AND APC ASSIGNMENT FOR THE TRANSCRANIAL MAGNETIC STIMULATION (TMS) THERAPY CPT CODES
CY 2017 CY 2017 CY 2017 OPPS CY 2018 CY 2018 CY 2018 OPPS CPT code Long descriptor OPPS SI OPPS APC payment OPPS SI OPPS APC payment rate rate
90867 ...... Therapeutic repetitive transcranial S 5722 $232.31 S 5722 Refer to OPPS magnetic stimulation (tms) treat- Addendum B. ment; initial, including cortical mapping, motor threshold deter- mination, delivery and manage- ment. 90868 ...... Therapeutic repetitive transcranial S 5722 232.31 S 5721 Refer to OPPS magnetic stimulation (tms) treat- Addendum B. ment; subsequent delivery and management, per session. 90869 ...... Therapeutic repetitive transcranial S 5721 127.10 S 5721 Refer to OPPS magnetic stimulation (tms) treat- Addendum B. ment; subsequent motor thresh- old re-determination with deliv- ery and management.
28. Transurethral Waterjet Ablation of coverage. According to the National are approved for coverage of the the Prostate (C–APC 5375) Institutes of Health (NIH) Category B device and related services, clinicaltrials.gov Web site, the estimated and routine services. We note that the On June 5, 2017, the Category B completion date of this study is August procedure associated with this study is Investigational Device Exemption (IDE) 2020. Under Medicare, studies with currently described by CPT code 0421T. study associated with the ‘‘Waterjet Category A designation are approved for Based on the recent Medicare coverage Ablation Therapy for Endoscopic coverage of routine services only, while of the IDE study, we revised the OPPS Resection of Prostate Tissue II (WATER)’’ met CMS’ standards for studies with the Category B designation status indicator assignment for CPT
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code 0421T from ‘‘E1’’ (Not paid by change through the October 2017 OPPS In the CY 2018 OPPS/ASC proposed Medicare when submitted on outpatient quarterly update CR (Transmittal 3864, rule, we solicited public comments on claims (any outpatient bill type)) to ‘‘J1’’ Change Request 10236, dated September the proposed APC and status indicator (Hospital Part B services paid through a 15, 2017), and further stated in this assignments for the code. Specifically, comprehensive APC) and assigned the same CR that the payment would be as listed in Table 66 below, we code to C–APC 5374 (Level 4 Urology effective on June 5, 2017, which is the proposed to continue to assign CPT and Related Services) to indicate that date of Medicare’s approval for code 0421T to C–APC 5374 for CY 2018. the procedure would be paid separately coverage. under the OPPS. We announced this
TABLE 66—PROPOSED CY 2018 STATUS INDICATOR (SI), APC ASSIGNMENT, AND PAYMENT FOR CPT CODE 0421T
Proposed CY 2017 Proposed Proposed CY 2018 CPT code Long descriptor CY 2017 CY 2017 OPPS CY 2018 CY 2018 OPPS OPPS SI OPPS APC payment OPPS SI OPPS APC payment rate rate
0421T ...... Transurethral waterjet ablation of J1 5374 $2,542.56 J1 5374 $2,609.60 prostate, including control of post- operative bleeding, including ultrasound guidance, complete (vas- ectomy, meatotomy, cystourethroscopy, urethral calibra- tion and/or dilation, and internal urethrotomy are included when per- formed).
Comment: Several commenters code 55873, proposed for assignment to that this procedure is currently in expressed concern over the proposed C–APC 5376), and high intensity clinical trial with an estimated study payment rate for CPT code 0421T and focused ultrasound (HIFU) of the completion date of August 2020. We requested a reassignment to either C– prostate (HCPCS code C9747, proposed believe that the procedure is clinically APC 5375 (Level 5 Urology and Related for assignment to C–APC 5376). Another similar to other procedures that are Services), which had a proposed commenter believed the Aquablation currently assigned to C–APC 5375. As payment rate of $3,597.65, or C–APC procedure requires more effort than the we do every year under the OPPS, we 5376 (Level 6 Urology and Related traditional transurethral resection of the will reevaluate the cost of the procedure Services), which had a proposed prostate (TURP) procedure (CPT code described by CPT code 0421T and its payment rate of $7,448.11 for the 52601, proposed for assignment to C– APC assignment for next year’s Aquablation procedure. The APC 5375) or the laser ablation of the rulemaking update. commenters stated that the proposed prostate procedure (GreenLight Laser payment rate for C–APC 5374 does not Therapy described by CPT code 52648, In summary, after consideration of the take into account the cost of the device, proposed for assignment to C–APC public comments, we are finalizing our the overhead costs, and the personnel 5375), and added that the TURP and CY 2018 proposal with modification. costs associated with providing the Aquablation each require general Specifically, we are revising the APC Aquablation procedure. One commenter anesthesia and take approximately 1 assignment for CPT code 0421T from stated that the Aquablation procedure is hour to perform. Several commenters proposed C–APC 5374 to C–APC 5375 dissimilar to the other procedures stated that the complexity of performing for CY 2018. Table 67 below lists the assigned to C–APC 5374, some of which the Aquablation procedure is similar to final status indicator and APC require the use of reusable equipment. the cryoablation of the prostate and assignments for CPT code 0421T for CY This same commenter reported that the HIFU procedures, of which both were 2018. We refer readers to Addendum B level of complexity in the performing proposed to be assigned to C–APC 5376. to this final rule with comment period the Aquablation procedure is Consequently, these same commenters for the payment rates for all codes comparable to those procedures in requested that CMS revisit the APC reported under the OPPS. In addition, C–APC 5375 and C–APC 5376. assignment for CPT code 0421T and we refer readers to Addendum A to this Specifically, as indicated by the consider a reassignment to C–APC 5376. final rule with comment period for the commenter, the Aquablation procedure Response: Based on our review of the status indicator meanings for all codes is similar to implanting brachytherapy procedure and input from our clinical reported under the OPPS. Both seeds into the prostate (CPT code 55875, advisors, we believe that a reassignment Addendum A and Addendum B are proposed for assignment to C–APC from C–APC 5374 to C–APC 5375 for available via the Internet on the CMS 5375), cryoablation of the prostate (CPT the Aquablation is appropriate. We note Web site.
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TABLE 67—FINAL CY 2018 STATUS INDICATOR (SI) AND APC ASSIGNMENT FOR CPT U0421T
CY 2017 CY 2017 CY 2017 OPPS CY 2018 CY 2018 CY 2018 OPPS CPT code Long descriptors OPPS SI OPPS APC payment OPPS SI OPPS APC payment rate rate
0421T ...... Transurethral waterjet ablation of J1 5374 $2,542.56 J1 5375 Refer to OPPS prostate, including control of Addendum B. post-operative bleeding, includ- ing ultrasound guidance, com- plete (vasectomy, meatotomy, cystourethroscopy, urethral cali- bration and/or dilation, and in- ternal urethrotomy are included when performed).
29. Transurethral Water Vapor Thermal Services), which has a geometric mean has a geometric mean cost of Therapy of the Prostate (C–APC 5373) cost of approximately $3,704 for CY approximately $1,695. We believe the For CY 2018, CMS received a New 2018. Rezu¯ m procedure shares similar Technology APC application requesting Based on our review of the resource and clinical homogeneity to a new HCPCS code for the Rezu¯ m application, the procedure, and input the other procedures currently assigned therapy. The Rezu¯ m procedure is a new from our clinical advisors, we agree that to C–APC 5373. treatment, and the Rezu¯ m System CPT code 53852 does not appropriately Table 68 below lists the final status associated with this procedure received describe the Rezu¯ m procedure. indicator and APC assignments for a 510(k) FDA clearance on August 27, Consequently, we are establishing HCPCS code C9748 for CY 2018. We 2015. The procedure utilizes water HCPCS code C9748 to appropriately refer readers to Addendum B to this vapor for the treatment of benign describe the procedure. Effective final rule with comment period for the prostatic hypertrophy (BPH). The January 1, 2018, HOPDs should report payment rates for all codes reported applicant maintained that there was HCPCS code C9748 to report the use of under the OPPS. In addition, we refer coding confusion about whether the the Rezu¯ m procedure for the treatment readers to Addendum A to this final procedure could be described by of BPH. In addition, based on cost rule with comment period for the status existing CPT code 53852 (Transurethral information submitted to CMS in the indicator meanings for all codes destruction of prostate tissue; by application, we believe that the reported under the OPPS. Both radiofrequency thermotherapy). We note procedure should appropriately be Addendum A and Addendum B are that CPT code 53852 is assigned to C– assigned to C–APC 5373 (Level 3 available via the Internet on the CMS APC 5375 (Level 5 Urology and Related Urology and Related Services), which Web site.
TABLE 68—FINAL CY 2018 STATUS INDICATOR (SI) AND APC ASSIGNMENT FOR THE TRANSURETHRAL WATER VAPOR THERMAL THERAPY OF THE PROSTATE
CY 2018 CY 2018 CY 2018 HCPCS code Long descriptor OPPS OPPS OPPS SI APC payment rate
C9748 ...... Transurethral destruction of prostate tissue; by radiofrequency water vapor J1 5373 Refer to OPPS (steam) thermal therapy. Addendum B.
We note that HCPCS code C9748 is IV. OPPS Payment for Devices we based the pass-through status assigned to comment indicator ‘‘NI’’ in expiration date for a device category on A. Pass-Through Payments for Devices Addendum B to this CY 2018 OPPS/ the date on which pass-through ASC final rule with comment period to 1. Beginning Eligibility Date for Device payment was effective for the category. indicate that we have assigned the code Pass-Through Status and Quarterly In the CY 2017 OPPS/ASC final rule an interim OPPS payment status for CY Expiration of Device Pass-Through with comment period (81 FR 79654), in 2018. We are inviting public comments Payments accordance with section on the interim status indicator and APC a. Background 1833(t)(6)(B)(iii)(II) of the Act, we assignments that will be finalized in the amended § 419.66(g) to provide that the CY 2019 OPPS/ASC final rule with Under section 1833(t)(6)(B)(iii) of the pass-through eligibility period for a comment period. Act, the period for which a device device category begins on the first date category eligible for transitional pass- on which pass-through payment is made through payments under the OPPS can under the OPPS for any medical device be in effect is at least 2 years but not described by such category. more than 3 years. Prior to CY 2017, our In addition, prior to CY 2017, our regulation at 42 CFR 419.66(g) provided policy was to propose and finalize the that this pass-through payment dates for expiration of pass-through eligibility period began on the date CMS status for device categories as part of the established a particular transitional OPPS annual update. This means that pass-through category of devices, and device pass-through status would expire
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at the end of a calendar year when at C2613, and C1822 into the costs related OPPS annual update. This means that least 2 years of pass-through payments to the procedure with which each device pass-through payment status have been made, regardless of the device is reported in the hospital claims would expire at the end of a calendar quarter in which the device was data. year when at least 2 years of pass- approved. In the CY 2017 OPPS/ASC Comment: Various stakeholders, through payments had been made, final rule with comment period (81 FR including physicians, device regardless of the quarter in which the 79655), we changed our policy to allow manufacturers, and professional device was approved for pass-through for quarterly expiration of pass-through societies, opposed the proposal to payment status. According to our payment status for devices, beginning package the costs of the device established policy (67 FR 66763), after with pass-through devices approved in described by HCPCS code C2623 into this eligibility period expires, payments CY 2017 and subsequent calendar years, the costs related to the procedure(s) for the costs of the device(s) are to afford a pass-through payment period with which the device is reported. The packaged into payment for the that is as close to a full 3 years as commenters specifically opposed procedures with which they are billed. possible for all pass-through payment packaging of the cost of the drug-coated The device category for HCPCS code devices. We refer readers to the CY 2017 balloons into the procedure described C2623 was established effective April 1, OPPS/ASC final rule with comment by CPT code 37224 (Revascularization, 2015, and will have been in effect for a period (81 FR 79648 through 79661) for endovascular, open or percutaneous, period of at least 2 years, but not more a full discussion of the changes to the femoral, popliteal artery(s), unilateral; than 3 years, when its eligibility expires device pass-through payment policy. with transluminal angioplasty). These on December 31, 2017. Therefore, this We also have an established policy to commenters stated concerns that the category is no longer eligible for pass- package the costs of the devices that are proposed payment rate for this through payments. In accordance with no longer eligible for pass-through procedure did not adequately reflect the our established policy, we are finalizing payments into the costs of the additional costs of drug-coated balloons our proposal to package payment for the procedures with which the devices are over non-drug-coated balloons, which costs of the device(s) described by this reported in the claims data used to set could limit patient access to the category into payment for the costs of the payment rates (67 FR 66763). technology. Several commenters the procedures with which they are described the clinical benefits provided reported. In response to the b. Expiration of Transitional Pass- by the drug-coated balloon in the Through Payments for Certain Devices recommendation of the HOP Panel from treatment of peripheral arterial disease the August 21, 2017 meeting, we will As stated earlier, section (PAD) and supported the continuation continue to track CPT code 37224 1833(t)(6)(B)(iii) of the Act requires that, of the pass-through status of the device (Revascularization, endovascular, open under the OPPS, a category of devices category for HCPCS code C2623 beyond or percutaneous, femoral, popliteal be eligible for transitional pass-through December 31, 2017. At the August 21, artery(s), unilateral; with transluminal payments for at least 2 years, but not 2017 meeting of the HOP Panel, the angioplasty) with HCPCS code C2623. more than 3 years. There currently are HOP Panel made a recommendation that We will share information on all items three device categories eligible for pass- CMS continue to track CPT code 37224 and services paid under the OPPS, through payment: (1) HCPCS code (Revascularization, endovascular, open including endovascular procedures, so C2623 (Catheter, transluminal or percutaneous, femoral, popliteal that the appropriate HOP Panel angioplasty, drug-coated, non-laser), artery(s), unilateral; with transluminal subcommittee may review the APCs for which was established effective April 1, angioplasty) with HCPCS code C2623, endovascular procedures and advise on 2015; (2) HCPCS code C2613 (Lung and that the appropriate HOP Panel whether more granularity (that is, more biopsy plug with delivery system), subcommittee review the APCs for APCs) is warranted. which was established effective July 1, endovascular procedures to determine 2015; and (3) HCPCS code C1822 whether more granularity (that is, more Comment: Some commenters, (Generator, neurostimulator APCs) is warranted. One commenter including device manufacturers and (implantable), high frequency, with supported the proposal to package the associations, stated that the geometric rechargeable battery and charging costs of the device described by HCPCS mean costs of the procedure described system), which was established effective code C2623 into the costs related to the by CPT code 37224 involving a drug- January 1, 2016. The pass-through procedure(s) with which the device is coated balloon were higher than the payment status of the device categories reported. The commenter stated that the geometric mean costs of the same for HCPCS codes C2623, C2613, and proposed payment rate provided under angioplasty procedure when a drug- C1822 will end on December 31, 2017. the OPPS for procedures using drug- coated balloon was not used and a plain We note that our new policy adopted in coated balloons was appropriate. This balloon angioplasty catheter was used the CY 2017 OPPS/ASC final rule with commenter also stated concerns over a instead. Specifically, these commenters comment period to allow for quarterly lack of scientific evidence of the presented their analysis of Medicare expiration of pass-through payment effectiveness of these devices outside of claims data which suggested that when status for devices applies to devices clinical trials. CPT code 37224 is billed with HCPCS approved in CY 2017 and subsequent Response: As mentioned earlier, code C2623, the geometric mean cost of years. As all the devices in these three under section 1833(t)(6)(B)(iii) of the these claims is $8,483, while the device categories were approved prior to Act, the period for which a device geometric mean cost of claims including CY 2017, we are applying our policy to category eligible for transitional pass- CPT code 37224 without HCPCS code expire them at the end of the calendar through payments under the OPPS can C2623 is $6,396. The commenters also year when at least 2 years of pass- be in effect is at least 2 years but not noted that the total geometric mean through payments have been made. more than 3 years. Our policy for costs for CPT code 37224, regardless of Therefore, in the CY 2018 OPPS/ASC devices approved for pass-through whether HCPCS code C2623 is billed proposed rule (82 FR 33610), we payment status prior to CY 2017 is to with CPT code 37224, is approximately proposed, beginning in CY 2018, to propose and finalize the dates for $7,153. These commenters requested package the costs of each of the devices expiration of pass-through payment that CMS create a new procedural described by HCPCS codes C2623, status for device categories as part of the HCPCS C-code or G-code for hospitals to
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use to differentiate procedures balloon angioplasty catheter, the higher procedure with which it is used; (2) the described by CPT code 37224 that use costs of the procedures involving the reported costs for devices described by drug-coated balloons from procedures drug-coated balloon are reflected in the HCPCS code C1822 in CY 2016 were described by CPT code 37224 that use claims data. Our analysis of the final lower than actual cost for the device due plain balloon angioplasty catheters, rule claims data revealed a geometric to hospital CCR ratios used to calculate with a suggested descriptor of mean cost of approximately $7,029 for device cost instead of implantable ‘‘Revascularization, endovascular, open CPT code 37224 based on 11,346 single device CCRs, which were used for many percutaneous, femoral, popliteal claims (out of 11,437 total claims). CPT hospitals to calculate device costs artery(s), unilateral; with transluminal code 37224 is assigned to C–APC 5192 starting in CY 2017; (3) the reported drug-coated balloon angioplasty’’. (Level 2 Endovascular Procedures), costs for devices described by HCPCS One commenter also referenced the which has a geometric mean cost of C1822 in CY 2016 were lower than proposal in the CY 2018 OPPS/ASC approximately $5,081. There is no 2 actual costs due to hospital cost proposed rule (82 FR 33579 and 33580) times violation in this C–APC. We also reporting errors, billing of HCPCS code to establish a HCPCS C-code to describe do not believe a C–APC complexity C1822 by hospitals that, according to blue light cystoscopy (HCPCS code adjustment would be applicable, based the device manufacturer, had not C9738 (Adjunctive blue light cystoscopy on existing criteria used to assign a purchased the device, hospitals not with fluorescent imaging agent (List complexity adjustment. We do not reporting use of the device, and other separately in addition to code for believe that the example the commenter claims reporting problems; and (4) primary procedure)) and to apply the C– raised is entirely analogous because the ending pass-through payment status APC complexity adjustment policy HCPCS C-code that the commenter would reduce access to the Senza SCS when this C-code is billed with specific referenced necessarily involves an System. The commenters stated that the white light cystoscopy codes. The additional procedure (blue light Senza SCS System helps beneficiaries commenter pointed out that, in the cystoscopy) in addition to white light manage chronic pain and reduces proposed rule, CMS stated that cystoscopy and the administration of opioid usage among beneficiaries with establishment of this C-code was the fluorescent imaging agent is the device. appropriate because CMS believed that required, which adds additional Response: Historically, a device blue light cystoscopy is a procedure time. In contrast, the use of approved for pass-through payment distinguishable service in comparison to a drug coated balloon does not involve status under the OPPS had an eligibility white light cystoscopy alone. CMS a separate procedure. period of at least 2 years but no more further stated that, with the C–APC We note that stakeholders who are than 3 years—with the pass-through complexity adjustment, qualifying interested in the establishment of a CPT payment period starting on the date combinations of the blue light procedure code to describe angioplasty when CMS established a particular cystoscopy C-code and white light procedures involving the use of drug- transitional category of devices (80 FR cystoscopy codes are paid at the next coated balloons may request a new 70415) and expiring at the end of a higher paying C–APC when billed procedure code from the AMA CPT calendar year when at least 2 years but together on the same claim. The Editorial Panel. no more than 3 years have passed. commenter requested that CMS take With regard to the request to create Effective January 1, 2017, we revised comparable steps to separately identify additional levels within the Vascular C– our policy to allow for a quarterly and pay for angioplasty procedures APC clinical family, this issue is expiration of pass-through payment involving drug-coated balloons. discussed in greater detail in section status for devices to afford a pass- Finally, several commenters III.D. of this final rule with comment through payment period that is as close referenced the HOP Panel’s period. As we do every year, we will to a full 3 years as possible for all pass- recommendation that CMS examine the review and evaluate the APC groupings through payment devices (81 FR 79655). number of APCs for endovascular based on the latest available data in the HCPCS code C1822 was established as procedures for CY 2018 and requested next rulemaking cycle. a pass-through payment category on CMS create two new levels within the Comment: Several commenters January 1, 2016, and will have received Endovascular C–APCs to provide higher requested that HCPCS code C1822 2 years of pass-through payment status payment for angioplasty procedures (Generator, neurostimulator on December 31, 2017, in accordance using a drug-coated balloon. (implantable), high frequency, with with the statutory requirement of Response: We believe that procedures rechargeable battery and charging receiving at least 2 years of pass-through with which the drug-coated balloons are system), otherwise known as the Senza payments, but not more than 3 years, used, specifically the procedure SCS System, receive an additional year and consistent with the policy in effect described by CPT code 37224, are of pass-through payment status for CY at the time the device pass-through appropriately described by the existing 2018. Reasons stated by the commenters payment period began for HCPCS code procedure code and do not believe it is included: (1) A belief that CMS has the C1822. Accordingly, the policy adopted necessary at this time to establish a authority under current law to extend in CY 2017 does not apply to devices HCPCS C-code or G-code to distinguish pass-through payment status for one approved for pass-through payment an angioplasty procedure with a drug- more year, for a total of 3 years, and status prior to that date. Likewise, the coated balloon from an angioplasty that, although CMS’ policy to allow change in CY 2017 from using the procedure without a drug-coated devices with transitional pass-through average hospital-wide CCR to the balloon. The OPPS is a prospective payment status as close to 3 years as implantable device CCR also was a payment system that relies on the possible was effective for device prospective policy change to use the principles of averaging, with some cases approvals on or after January 1, 2017, best available data in a given year to in an APC being more costly than others CMS has the authority to grant the third determine device pass-through (and some cases being less costly). year of pass-through payment status on payment. Although there is some evidence of a case-by-case basis for devices that With respect to comments expressing higher geometric mean costs when a were granted pass-through payment concerns that the reported costs for drug-coated balloon is used for certain status prior to CY 2017 based on HCPCS code C1822 for CY 2016 were angioplasty procedures versus a plain specific characteristics of the device and lower due to hospital cost reporting
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errors, as we have stated in Section 20.5 Response: We appreciate the market availability after FDA approval (Clarification of HCPCS Code to commenter’s support. or clearance is granted, in which case Revenue Code Reporting) of Chapter 4 We did not receive any public CMS will consider the pass-through of the Medicare Claims Processing comments regarding the proposal to payment application if it is submitted Manual, hospitals are responsible for package the payment for the costs of the within 3 years from the date of market reporting the correct revenue code on device described by HCPCS code C2623 availability; (2) the device is determined the claim form. Specifically, we state into the payment for the costs related to to be reasonable and necessary for the that we do not instruct hospitals on how the procedure with which the device is diagnosis or treatment of an illness or to report the assignment of HCPCS reported. injury or to improve the functioning of codes to revenue codes for services After consideration of the public a malformed body part, as required by provided under OPPS because hospitals’ comments we received, we are section 1862(a)(1)(A) of the Act; and (3) costs vary. Where explicit instructions finalizing our proposal, without the device is an integral part of the are not provided, providers should modification, to package the payment service furnished, is used for one report their charges under the revenue for the costs of each of the devices patient only, comes in contact with code that will result in the charges being described by HCPCS codes C2623, human tissue, and is surgically assigned to the same cost center to C2613, and C1822 into the payment for implanted or inserted (either which the cost of those services are the costs related to the procedure with permanently or temporarily), or applied assigned in the cost report. We note that which each device is reported in the in or on a wound or other skin lesion. the Medicare cost report form allows hospital claims data. In addition, according to § 419.66(b)(4), hospitals to report in a manner that is a device is not eligible to be considered 2. New Device Pass-Through for device pass-through payment if it is consistent with their own financial Applications accounting systems and, therefore, any of the following: (1) Equipment, an should be accurate for each individual a. Background instrument, apparatus, implement, or item of this type for which depreciation hospital. Moreover, we believe that the Section 1833(t)(6) of the Act provides and financing expenses are recovered as cost report data and their use in the for pass-through payments for devices, depreciation assets as defined in OPPS cost estimation and payment rate and section 1833(t)(6)(B) of the Act Chapter 1 of the Medicare Provider development process, combined with requires CMS to use categories in Reimbursement Manual (CMS Pub. 15– potential penalties for inaccurate determining the eligibility of devices for 1); or (2) a material or supply furnished reporting, provide financial incentives pass-through payments. As part of incident to a service (for example, a for hospitals to report costs accurately. implementing the statute through suture, customized surgical kit, or clip, Furthermore, as we have stated regulations, we have continued to repeatedly, beyond our standard OPPS other than a radiological site marker). believe that it is important for hospitals Separately, we use the following trimming methodology that we apply to to receive pass-through payments for those claims that have passed various criteria, as set forth under § 419.66(c), to devices that offer substantial clinical determine whether a new category of types of claims processing edits, it is not improvement in the treatment of our general policy to judge the accuracy pass-through payment devices should Medicare beneficiaries to facilitate be established. The device to be of hospital coding and charging for access by beneficiaries to the advantages purposes of ratesetting. (We refer included in the new category must— of the new technology. Conversely, we • Not be appropriately described by readers to the CY 2011 OPPS/ASC final have noted that the need for additional an existing category or by any category rule with comment period (75 FR payments for devices that offer little or previously in effect established for 71838) for further discussion.) no clinical improvement over transitional pass-through payments, and Commenters writing in support of previously existing devices is less was not being paid for as an outpatient extending the pass-through payment apparent. In such cases, these devices service as of December 31, 1996; period for HCPCS code C1822 also can still be used by hospitals, and • Have an average cost that is not stated that access to the service covered hospitals will be paid for them through ‘‘insignificant’’ relative to the payment by HCPCS code C1822 could be reduced appropriate APC payment. Moreover, a amount for the procedure or service if pass-through payment status for goal is to target pass-through payments with which the device is associated as HCPCS code C1822 is removed. Because for those devices where cost determined under § 419.66(d) by reported costs for CPT code 63685 considerations might be most likely to demonstrating: (1) The estimated appear to be consistent with or without interfere with patient access (66 FR average reasonable costs of devices in being reported in combination with 55852; 67 FR 66782; and 70 FR 68629). the category exceeds 25 percent of the HCPCS code C1822, we do not As specified in regulations at 42 CFR applicable APC payment amount for the anticipate a significant impact to the 419.66(b)(1) through (b)(3), to be eligible service related to the category of payment amount for CPT code 63685 for transitional pass-through payment devices; (2) the estimated average once HCPCS code C1822 is removed under the OPPS, a device must meet the reasonable cost of the devices in the from pass-through payment status. We following criteria: (1) If required by category exceeds the cost of the device- anticipate that hospitals will be able to FDA, the device must have received related portion of the APC payment adjust to any possible changes to the FDA approval or clearance (except for a amount for the related service by at least payment for the service. device that has received an FDA 25 percent; and (3) the difference Comment: One commenter, another investigational device exemption (IDE) between the estimated average device manufacturer, agreed with CMS’ and has been classified as a Category B reasonable cost of the devices in the proposal to end pass-through payment device by the FDA), or another category and the portion of the APC status of HCPCS code C1822 on appropriate FDA exemption; and the payment amount for the device exceeds December 31, 2017, stating that the pass-through payment application must 10 percent of the APC payment amount decision to end pass-through payment be submitted within 3 years from the for the related service (with the status is consistent with CMS policy date of the initial FDA approval or exception of brachytherapy and and there is no need to apply the policy clearance, if required, unless there is a temperature-monitored cryoblation, established in CY 2017 retroactively. documented, verifiable delay in U.S. which are exempt from the cost
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requirements as specified at to be included for the CY 2018 OPPS/ newness criterion, Architect® Px may §§ 419.66(c)(3) and (e)); and ASC proposed rule. All applications not meet the newness criterion. We • Demonstrate a substantial clinical were received in the second quarter of invited public comments on this issue. improvement, that is, substantially 2016. None of the five applications were Comment: One commenter, the improve the diagnosis or treatment of an approved for device pass-through manufacturer, stated that Architect® Px illness or injury or improve the payment during the quarterly review is substantially different than its functioning of a malformed body part process. predicate product, Unite Biomatrix, and compared to the benefits of a device or Applications received for the later should be considered to meet the devices in a previously established deadlines for the remaining 2017 newness criterion for device pass- category or other available treatment. quarters (June 1, September 1, and through payment. The commenter Beginning in CY 2016, we changed December 1), if any, will be presented pointed out the following: Architect® Px our device pass-through evaluation and in the CY 2019 OPPS/ASC proposed uses a different process from Unite determination process. Device pass- rule. We note that the quarterly Biomatrix to stabilize the equine through applications are still submitted application process and requirements pericardium. Architect® Px is de- to CMS through the quarterly have not changed in light of the hydrated, packaged dry in a foil pouch, subregulatory process, but the addition of rulemaking review. Detailed and is sterilized by radiation. Unite applications will be subject to notice- instructions on submission of a Biomatrix is packaged wet in a jar and and-comment rulemaking in the next quarterly device pass-through payment is not sterilized using radiation. The applicable OPPS annual rulemaking application are included on the CMS new process that is used to cycle. Under this process, all Web site at: https://www.cms.gov/ manufacturer Architect® Px was found applications that are preliminarily Medicare/Medicare-Fee-for-Service- by researchers in 2016 to add key approved upon quarterly review will Payment/HospitalOutpatientPPS/ properties to the device that promote automatically be included in the next Downloads/catapp.pdf. A discussion of the use of endogenous collagen and applicable OPPS annual rulemaking the five applications received by the growth factors to support healing. The cycle, while submitters of applications March 1, 2017 deadline is presented commenter implied that Unite that are not approved upon quarterly below, as detailed in the CY 2018 OPPS/ Biomatrix does not contain these key review will have the option of being ASC proposed rule (82 FR 33611 properties. included in the next applicable OPPS through 33618). Response: The statements by the annual rulemaking cycle or ® manufacturer about the differences in withdrawing their application from (1) Architect Px performance between Architect® Px and consideration. Under this notice-and- Harbor MedTech, Inc. submitted an Unite Biomatrix appear to be different comment process, applicants may application for a new device category than what was stated in the device pass- submit new evidence, such as clinical for transitional pass-through payment through application. The application trial results published in a peer- status for Architect® Px. Architect® Px stated that, despite different packaging, reviewed journal or other materials for is a collagen biomatrix comprised of a the two products were identical. consideration during the public stabilized extracellular matrix derived However, we acknowledge that the comment process for the proposed rule. from equine pericardium. The equine research cited by the manufacturer of This process allows those applications pericardium is stabilized to become a substantial performance differences that we are able to determine meet all catalyst and scaffold for use by between Architect® Px and Unite the criteria for device pass-through autologous tissue regeneration factors. Biomatrix is from 2016, and the findings payment under the quarterly review Architect® Px is packaged as an may not have been available when the process to receive timely pass-through individual unit in sizes ranging from 2 device pass-through payment payment status, while still allowing for cm x 2 cm up to 10 cm x 15 cm and application was submitted. For a transparent, public review process for is approximately 0.75 mm thick. purposes of the device pass-through ® all applications (80 FR 70417 through Architect Px typically requires only payment process, we are persuaded by 70418). one application. The applicant asserted this additional information and have More details on the requirements for that it is clinically superior to other skin determined that Architect® Px does device pass-through payment substitutes that work by flooding the meet the newness criterion based on the applications are included on the CMS wound with nonautologous collagen additional performance information Web site in the application form itself and growth factors because Architect® supplied by the manufacturer. at: http://www.cms.gov/Medicare/ Px attracts and concentrates the With respect to the eligibility criterion Medicare-Fee-for-Service-Payment/ patient’s own autologous collagen and at § 419.66(b)(3), according to the HospitalOutpatientPPS/passthrough_ growth factors to support healing. applicant, Architect® Px is a skin payment.html, in the ‘‘Downloads’’ With respect to the newness criterion substitute product that is integral to the section. In addition, CMS is amenable to at § 419.66(b)(1), the applicant received service provided, is used for one patient ® meeting with applicants or potential FDA clearance for Architect Px on only, comes in contact with human applicants to discuss research trial September 12, 2014, and its June 1, 2016 skin, and is surgically inserted into the design in advance of any device pass- application was submitted within 3 patient. The applicant also claims through application or to discuss years of FDA clearance. However, Unite Architect® Px meets the device application criteria, including the BioMatrix, cleared by the FDA on June eligibility requirements of § 419.66(b)(4) substantial clinical improvement 20, 2007, is claimed as a predicate of because Architect® Px is not an ® ® criterion. Architect Px. The Architect Px instrument, apparatus, implement, or application states that ‘‘. . . while item for which depreciation and b. Applications Received for Device packaged differently, Architect® Px and financing expenses are recovered, and it Pass-Through Payment for CY 2018 Unite BioMatrix are identical . . . they is not a supply or material. We received five applications by the are both stabilized equine pericardium The criteria for establishing new March 1, 2017 quarterly deadline, manufactured using the same processes device categories are specified at which was the last quarterly deadline . . . .’’ If the date for FDA clearance for § 419.66(c). The first criterion, at for applications to be received in time Unite BioMatrix is used to evaluate the § 419.66(c)(1), provides that CMS
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determines that a device to be included healing and does not need to be met. The applicant provided the in the category is not appropriately reapplied. The commmenter also stated following information in support of the described by any of the existing that skin substitutes that degrade need cost significance requirements: categories or by any category previously to be reapplied multiple times and there Architect® Px would be reported with in effect, and was not being paid for as is the risk that reapplying the skin CPT codes 15271 through 15278, which an outpatient service as of December 31, substitute may interrupt the wound cover the application of skin substitute 1996. We have not identified an existing healing process which drives up the grafts to different areas of the body for pass-through category that describes costs of medical care. The commenter high-cost skin substitutes. To meet the Architect® Px. Harbor MedTech, Inc. believed that Architect® Px is the first cost criterion for device pass-through suggested a new device category skin substitute that totally aligned with payment, a device must pass all three descriptor of ‘‘Stabilized Skin Substitute the Quality and Value of Care objectives tests of the cost criteria for at least one for Autologous Tissue Regeneration’’ for of the Medicare Access and CHIP APC. CPT codes 15271 through 15278 Architect® Px. We invited public Reauthorization Act of 2015 (MACRA). are assigned to either APC 5054 (Level comments on this issue. Lastly, the commenter stated that other 4 Skin Procedures), with a CY 2016 We did not receive any public skin substitute products have previously payment rate of $1,411.21 and a device comments on this issue. We are received pass-through payment offset of $4.52, or APC 5055 (Level 5 confirming that there is no existing approval by presenting similar data as Skin Procedures), with a CY 2016 pass-through category that describes have been presented for Architect® Px. payment rate of $2,137.49 and a device Architect® Px and have determined that Response: The commenter has offset of $25.44. According to the Architect® Px meets this eligibility provided additional information about applicant, the cost of the substitute graft criterion. the potential beneficial qualities of procedures when performed with The second criterion for establishing Architect® Px. However, the commenter Architect® Px is $5,495. a device category, at § 419.66(c)(2), has provided no additional studies that Section 419.66(d)(1), the first cost provides that CMS determines that a demonstrate that its use results in a significance requirement, provides that device to be included in the category substantial clinical improvement the estimated average reasonable cost of has demonstrated that it will relative to other skin substitute and devices in the category must exceed 25 substantially improve the diagnosis or wound healing products available on percent of the applicable APC payment treatment of an illness or injury or the market. The commenter mentioned amount for the service related to the improve the functioning of a malformed that skin substitutes had previously category of devices. The estimated body part compared to the benefits of a received pass-through payment status average reasonable cost of $5,495 for device or devices in a previously based on the same type of information Architect® Px exceeds the applicable established category or other available the manufacturer provided in its device APC amount for the service related to treatment. With regard to the substantial pass-through payment application and the category of devices of $1,411.21 by clinical improvement criterion, the in its comments on the proposed rule. 389 percent ($5,495/$1,411.21 × 100 applicant only identified two references, However, the commenter is referring to percent = 389 percent). Therefore, it neither of which we believe provide a previous process to evaluate skin appears that Architect® Px meets the evidence of substantial clinical substitutes for pass-through payment first cost significance test. improvement. One reference is a 2012 eligibility (the drugs and biological The second cost significance test, at summary report 3 of skin substitute pass-through payment process), which § 419.66(d)(2), provides that the products that can be used to treat did not require evidence of a substantial estimated average reasonable cost of the chronic wounds that only describes clinical improvement. Since CY 2015, devices in the category must exceed the characteristics of the predecessor skin substitutes have been evaluated cost of the device-related portion of the product to Architect® Px with no using the medical device pass-through APC payment amount for the related efficacy or performance information. payment process (79 FR 66885 through service by at least 25 percent, which The second reference 4 is a small 66888), which includes the criterion for means the device cost needs to be at observational study of 34 subjects with substantial clinical improvement. least 125 percent of the offset amount no comparison group. We invited public Applicants must demonstrate that the (the device-related portion of the APC comments on whether Architect® Px device under consideration for pass- found on the offset list). The estimated through payment status will average reasonable cost of $5,495 for meets the substantial clinical ® improvement criterion. substantially improve the diagnosis or Architect Px exceeds the device- Comment: One commenter, the treatment of an illness or injury or related portion of the APC payment manufacturer, stated that the inclusion improve the functioning of a malformed amount for the related service of $4.52 of stabilized equine pericardium is an body part compared to the benefits of a by 121,571 percent ($5,495/$4.52 × 100 extremely important property of device or devices in a previously percent = 121,571 percent). Therefore, Architect® Px and Unite Biomatrix, and established category or other available we stated in the proposed rule that it ® that this property allows these products treatment. The commenter has not appears that Architect Px meets the to stay on a chronic wound, resist provided additional information second cost significance test. degradation, and remain on the wound showing substantial clinical Section 419.66(d)(3), the third cost until it heals. The commenter stated that improvement. Therefore, we determine significance test, requires that the ® Architect® Px is a nondegrading skin that Architect Px does not meet the difference between the estimated substitute that constantly supports criterion for substantial clinical average reasonable cost of the devices in improvement. the category and the portion of the APC 3 Snyder, D.L. et al. Skin Substitutes for Treating The third criterion for establishing a payment amount for the device must Chronic Wounds. Technology Assessment Report. device category, at § 419.66(c)(3), exceed 10 percent of the APC payment Project ID: HCPR0610. AHRQ. December 18, 2012. requires us to determine that the cost of amount for the related service. The 4 Alexander JH, Yeager DA, et al. Equine the device is not insignificant, as difference between the estimated Pericardium as a Biological Covering for the described in § 419.66(d). Section average reasonable cost of $5,495 for Treatment of Diabetic Foot Wounds; a Prospective ® Study. J Am Podiatric Assoc., 2012 Sep–Oct.:102 419.66(d) includes three cost Architect Px and the portion of the (5): 352–358. significance criteria that must each be APC payment amount for the device of
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$4.52 exceeds 10 percent at 389 percent There is a lower cytokine/GF materials furnished incident to a (($5,495¥$4.52)/$1,411.21) × 100 concentration profile in Plurivest and a service. percent = 389 percent). Therefore, it higher concentration of CAP and The criteria for establishing new appears that Architect® Px meets the cytokine/GF in Dermavest. device categories are specified at third cost significance test. Based on the With respect to the newness criterion § 419.66(c). The first criterion, at costs submitted by the applicant and the at § 419.66(b)(1), the applicant indicated § 419.66(c)(1), provides that CMS calculations noted earlier, we believe that the product conforms to the determines that a device to be included that Architect® Px meets the cost requirements for Human Cells, Tissues, in the category is not appropriately criterion at § 419.66(c)(3) for new device and Cellular and Tissue-Based Products described by any of the existing categories. (HCT/Ps) regulated solely under section categories or by any category previously We invited public comments on 361 of the Public Health Service (PHS) in effect, and was not being paid for as ® whether Architect Px meets the device Act and 21 CFR part 1271. For these an outpatient service as of December 31, pass-through payment criteria discussed products, FDA requires, among other 1996. We have not identified an existing in this section. things, that the manufacturer register pass-through payment category that We did not receive any public and list its HCT/Ps with the Center for describes Dermavest and Plurivest comments relating to whether HPCTM. The applicant proposed a ® Biologics Evaluation and Research Architect Px meets the device pass- (CBER) within 5 days after beginning category descriptor for Dermavest and through payment cost criterion. As operations and update their registrations Plurivest of ‘‘Human placental ® stated earlier, we believe that Architect annually. AediCell, Inc. has an FDA connective tissue matrix (HPCTM), Px meets the cost criterion at field establishment identifier (FEI) comprised of tissue sourced from the § 419.66(c)(3) for new device categories. under the HHS-FDA-Establishment placental disk, amnion/chorion, and However after consideration of the Registration and Listing for Human umbilical cord for the intention of public comments we received, we are Cells, Tissues, and Cellular and Tissue- replacing or supplementing damaged or not approving device pass-through ® Based Products (HCT/Ps) and submitted inadequate integumental issue.’’ We payment status for Architect Px for CY with its application the annual invited public comments on this issue. 2018. registration/listing for Dermavest and Comment: One commenter, the (2) Dermavest and Plurivest Human Plurivest dated November 9, 2015. The manufacturer, supported CMS’ Placental Connective Tissue Matrix applicant noted that the initial statement that CMS had not identified (HPCTM) registration for the manufacture of an existing pass-through payment category that describes Dermavest and Aedicell, Inc. submitted an Dermavest was submitted to the CBER on October 28, 2013, and the Plurivest HPTCM. application for a new device category Response: At this time, we still have for transitional pass-through payment registration of Plurivest was submitted the following year on November 14, not identified an existing pass-through status for Dermavest and Plurivest payment category that describes human placental connective tissue 2014. The registration forms including these dates were not included in the Dermavest and Plurivest HPCTM. matrix (HPCTM). Dermavest and The second criterion for establishing Plurivest HPCTM use tissue sourced application. Therefore, it is unclear if the newness criterion is met. a device category, at § 419.66(c)(2), from the placental disk, amnion/ provides that CMS determines that a chorion, and umbilical cord to replace Comment: One commenter, the manufacturer, provided an FDA device to be included in the category or supplement damaged tissue. The has demonstrated that it will applicant stated that Dermavest and registration form for the product that indicated that there was change in substantially improve the diagnosis or Plurivest replace or supplement treatment of an illness or injury or damaged or inadequate integumental information for the Dermavest product submitted on December 18, 2013. The improve the functioning of a malformed tissue by providing a scaffold to entrap body part compared to the benefits of a migrating cells for repopulation. The manufacturer also submitted a document indicating that a registration device or devices in a previously applicant stated that the products may established category or other available be clinically indicated for the following form was submitted to FDA on October treatment. With respect to this criterion, conditions: Partial and full thickness 20, 2014 to change the name of the the applicant provided several wounds; pressure ulcers; venous ulcers; product to Dermavest/Plurivest. background studies showing general chronic vascular ulcers; diabetic ulcers; Response: Based on the information evidence that placental tissue, umbilical trauma wounds (abrasions, lacerations, submitted by the manufacturer, we are cord, and amnion membrane products second degree burns, and skin tears); unable to determine that Dermavest and are effective in the treatment of various drainage wounds; and surgical wounds Plurivest meet the newness criterion at wounds and ulcers. However, these (donor sites/grafts post mohs surgery, § 419.66(b)(1). studies were not specific to Dermavest post laser surgery, and podiatric). With respect to the eligibility criterion and Plurivest HPCTM. The applicant Dermavest and Plurivest HPCTM are at § 419.66(b)(3), according to the submitted two poster presentations applied to the area of inadequate or applicant, Dermavest and Plurivest are describing case studies that evaluated damaged tissue, moistened if necessary skin substitute products that are integral the wound healing time and wound and covered with a nonadherent to the service provided, are used for one characteristics of patients with diabetic secondary dressing. While the patient only, come in contact with and venous ulcers treated with application does not distinguish human skin, and are applied in or on a Dermavest and Plurivest HPCTM. Both between the Dermavest and Plurivest wound or other skin lesion. The studies were described as case series products, the AediCell Inc. Web site applicant also claimed Dermavest and and, as such, lacked blinding, states that the two products differ by Plurivest meet the device eligibility randomization, and control groups. The dosage. According to information on the requirements of § 419.66(b)(4) because first poster,5 presented in 2015, Web site at www.aedicell.com, each they are not instruments, apparatuses, product contains different tissue cell implements, or items for which 5 Connell et al., Human placental connective attachment proteins (CAP) and depreciation and financing expenses are tissue matrix in the treatment of chronic wounds: cytokine/growth factors (GF) profiles. recovered, and they are not supplies or A prospective multi-center case series. 2015 at
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described a prospective, multi-center comparators, including the number of improvement relative to existing case series with a small number of patients included in the studies, the therapies currently available for wound participants (n=15). The study evaluated number of wounds treated, and the care. wound healing time and wound purpose of the study. Based on the The third criterion for establishing a characteristics of patients with various results presented in the poster, the device category, at § 419.66(c)(3), etiologies. The patients were treated applicant concluded that HPCTM requires us to determine that the cost of with up to two 6 cm2 pieces of provides an effective alternative to other the device is not insignificant, as Dermavest per application on wounds skin replacement products. described in § 419.66(d). Section up to 44 cm2. Results were presented for In the CY 2018 OPPS/ASC proposed 419.66(d) includes three cost diabetic and venous ulcer cases and rule, we stated that we were concerned significance criteria that must each be showed a week 4 percent area reduction that the research provided did not met. The applicant provided the (PAR) of 71 percent for diabetic ulcers clinically demonstrate the active following information in support of the and 50 percent for venous ulcers. Eighty ingredients of the product(s) that might cost significance requirements. The percent of the diabetic ulcer cases and distinguish the product from others, the applicant stated that Dermavest and 50 percent of the venous ulcer cases had correct dosing of the product(s), the Plurivest HPCTM would be reported a week 4 PAR of greater than 40 percent. amount of durable wound closure with with CPT codes 15271, 15272, 15273, The second poster,6 presented in the product(s) compared to standard of 15274, 15275, 15276, 15277, and 15278. 2016, also described a case series that care in studies with rigorous trial CPT codes 15272, 15274, 15276, and evaluated wound healing time and design/implementation, and the amount 15278 are add-on codes assigned status wound characteristics of patients with of durable wound closure with the indicator ‘‘N’’, which means payment is various etiologies (n=8). The poster product(s) compared to other products packaged under the OPPS. CPT codes stated that the patients were treated in studies with rigorous trial design/ 15271 and 15275 are assigned to APC with pieces of HPCTM according to implementation. We stated in the 5054 (Level 4 Skin Procedures), and manufacturer guidelines on wounds proposed rule that, based on the CPT codes 15273 and 15277 are ranging in size up to 3.8 cm2. The evidence submitted with the assigned to APC 5055 (Level 5 Skin methods presented in the poster do not application, we were not yet convinced Procedures). To meet the cost criterion specify whether the patients were that the Dermavest and Plurivest for device pass-through payment, a treated with Dermavest or Plurivest, or HPCTM provide a substantial clinical device must pass all three tests of the both. The results presented in the poster improvement over other treatments for cost criterion for at least one APC. For compile Dermavest data from two case wound care. We invited public our calculations, we used APC 5054 series presented at the Society for comments on whether the Dermavest (Level 4 Skin Procedures), which had a Advanced Wound Care (SAWC) annual and Plurivest HPCTM meet this CY 2016 payment rate of $1,411 and a meeting. It was unclear whether there criterion. device offset amount of $4.52 at the time was overlap between the patients used Comment: One commenter, the the application was received. According in the 2015 and 2016 case series manufacturer, provided information to the applicant, the cost of a sheet of included in the application. The regarding the active ingredients and 2x3 cm Dermavest is $550, and the cost compiled Dermavest data were concentrations of active ingredients of of a sheet of 2x3 cm Plurivest is $500. compared to the 4-week PAR results for the product as compared to other skin Section 419.66(d)(1), the first cost diabetic and venous ulcers from two substitutes. The comment also included significance requirement, provides that other noncontemporaneous studies personal statements from physicians the estimated average reasonable cost of evaluating different skin replacement who used the product and attested to its devices in the category must exceed 25 products. The results showed, at week clinical benefit over the current percent of the applicable APC payment 4, approximately 80 percent of the standard of care. The physicians’ amount for the service related to the Dermavest-treated diabetic ulcer cases statements also noted that a randomized category of devices. The estimated had a PAR of greater than 50 percent in controlled trial that compares the average reasonable cost of $550 for comparison to approximately 60 percent product to the standard of care and to Dermavest and Plurivest exceeds 39 of cases and approximately 30 percent other advanced human tissue products, percent of the applicable APC payment of cases, respectively, in the comparison as well as registry studies, would be amount for the service related to the studies using other skin replacement helpful in proving the substantial category of devices of $1,411 ($550/ products. The results also showed that, clinical improvement provided by $1,411 × 100 = 39 percent). Therefore, at week 4, approximately 60 percent of Dermavest/Plurivest HPTCM. The we stated in the proposed rule that we the Dermavest-treated venous ulcer manufacturer also stated that it was believe Dermavest and Plurivest meet cases had a PAR of greater than 40 endeavoring to enter into a registry the first cost significance test. percent in comparison to approximately study and two randomized controlled The second cost significance test, at 50 percent of cases and approximately trials using other high tiered skin § 419.66(d)(2), provides that the 30 percent of cases in the comparison substitutes as comparators. estimated average reasonable cost of the studies treated with other skin Response: We appreciate the devices in the category must exceed the replacement products. There were commenters’ responses on the cost of the device-related portion of the multiple differences between the Dermavest and Plurivest HPCTM APC payment amount for the related Dermavest studies included in the application. However, the commenters service by at least 25 percent, which poster presentations and these two did not provide new empirical evidence means that the device cost needs to be additional studies presented as that addressed our concerns that the at least 125 percent of the offset amount studies included with the application (the device-related portion of the APC Society of Advanced Wound Healing (SAWC) were described as case series and, as found on the offset list). The estimated Spring meeting. such, lacked blinding, randomization, average reasonable cost of $550 for 6 McGuire and Sebag, The use of a new placental and control groups. At this time, we Dermavest and Plurivest exceeds the acellular tissue product in the management of chronic wounds: A case series. 2016 at the Society have not been able to determine that cost of the device-related portion of the of Advanced Wound Healing (SAWC) Spring Dermavest and Plurivest HPCTM APC payment amount for the related meeting. represents a substantial clinical service of $4.52 by 12,168 percent
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($550/$4.52) × 100 = 12,168 percent). restoration, foot and ankle repairs, and in effect, and was not being paid for as Therefore, we stated in the proposed chronic wounds. an outpatient service as of December 31, rule that we believe that Dermavest and With respect to the newness criterion 1996. We have not identified an existing Plurivest meet the second cost at § 419.66(b)(1), the applicant indicated pass-through payment device category significance test. that Flo¯Graft® and Flo¯graft Neogenesis® that describes Flo¯Graft®/Flo¯graft The third cost significance test, at conform to the requirements for Human Neogenesis®. The application suggested § 419.66(d)(3), requires that the Cells, Tissues, and Cellular and Tissue- a payment device category for difference between the estimated Based Products (HCT/Ps) regulated Flo¯Graft®/Flo¯graft Neogenesis® with a average reasonable cost of the devices in solely under section 361 of the PHS Act category descriptor of ‘‘Injectable the category and the portion of the APC and 21 CFR part 1271. For these Amniotic Fluid Allograft’’. We invited payment amount for the device must products, FDA requires, among other public comments on this issue. exceed 10 percent of the APC payment things, that the manufacturer register We did not receive any public amount for the related service. The and list their HCT/Ps with the Center for comments on this issue, and at this difference between the estimated Biologics Evaluation and Research time, we have not identified an existing average reasonable cost of $550 for (CBER) within 5 days after beginning pass-through category that describes Dermavest and Plurivest and the portion operations and update their registrations Flo¯Graft®/Flo¯graft Neogenesis®. of the APC payment amount for the annually. Applied Biologics, LLC has The second criterion for establishing device of $4.52 exceeds the APC two FDA field establishment identifiers a device category, at § 419.66(c)(2), payment amount for the related service (FEI) under the HHS-FDA-Establishment provides that CMS determines that a of $1,411 by 38.6 percent Registration and Listing for Human device to be included in the category (($550¥$4.52)/$1,411 × 100 = 38.6 Cells, Tissues, and Cellular and Tissue- has demonstrated that it will percent). Therefore, we stated in the Based Products (HCT/Ps). Both substantially improve the diagnosis or proposed rule that we believe that registration forms list the product as treatment of an illness or injury or Dermavest and Plurivest meet the third ‘‘Flo¯Graft®’’. The applicant submitted improve the functioning of a malformed cost significance test. an initial registration/listing for one FEI body part compared to the benefits of a We invited public comments on dated June 8, 2015, as well as an annual device or devices in a previously whether Dermavest and Plurivest meet registration/listing for a different FEI established category or other available the device pass-through payment cost dated December 1, 2014. The first date treatment. With respect to the criteria discussed in this section. of U.S. sale for Flo¯Graft® was May 23, substantial clinical improvement We did not receive any public 2013. It is not clear when the initial criterion, the applicant submitted comments on this issue. We continue to CBER filing occurred for the Flo¯Graft® several peer-reviewed publications that believe that Dermavest and Plurivest product. Therefore, it is unclear if the provided general evidence that amniotic meet the device pass-through payment newness criterion for the Flo¯Graft® fluid and amniotic membrane-based cost criteria. product is met. products significantly reduce recovery After consideration of the public Comment: One commenter, the time. However, these studies did not comments we received, we are not manufacturer, supplied information include the use of the Flo¯Graft®/Flo¯graft approving device pass-through payment indicating that the initial registration Neogenesis® product. The applicant did ® status for the Dermavest and Plurivest forms for Flo¯Graft and Flo¯Graft list several studies in the application ® HPCTM for CY 2018. Neogenesis were submitted on that involved the use of the Flo¯Graft®/ ® (3) Flo¯Graft®/Flo¯graft Neogenesis® February 24, 2015 and were validated Flo¯graft Neogenesis product. Of these by FDA on June 8, 2015. studies, five unpublished studies were Applied Biologics, LLC submitted an Response: Based on the information available for review. The five studies application for a new device category submitted by the manufacturer, we submitted with the application were for transitional pass-through payment believe that the product meets the described as case studies, case series, or ¯ ® ¯ status for FloGraft /Flograft newness criterion at § 419.66(b)(1). retrospective cohort studies. The studies ® ¯ ® ¯ Neogenesis . FloGraft /Flograft With respect to the eligibility criterion lacked random allocation, blinding, and Neogenesis® is an injectable, human at § 419.66(b)(3), according to the a comparison group. The first study 7 placental amniotic fluid. It is an applicant, Flo¯Graft® and Flo¯graft ® described a retrospective cohort study of allograft derived from human birth Neogenesis are integral to the service 30 patients. The studies showed that 93 tissue recovered from a live, healthy C- provided, are used for one patient only, percent of the patients (n=14) who section birth. The allograft is used to ® come in contact with human skin, and received a Flo¯Graft injection, coupled augment tissue to bone and tissue to are applied in or on a wound or other with conservative, nonsurgical tissue repairs. The allograft is implanted skin lesion. The applicant also claimed treatment plan to treat their Morton’s at the surgical site at the end of the ® Flo¯Graft and Flo¯graft Neogenesis meet Nerve entrapment condition, had their procedure using a needle and syringe the device eligibility requirements of issue resolved compared to 20 percent under direct visualization. The § 419.66(b)(4) because they are not of patients (n=3) who did not receive applicant claimed that the product ® instruments, apparatuses, implements, Flo¯Graft injection, coupled with helps drive healing towards native or items for which depreciation and conservative, nonsurgical treatment tissue regeneration and away from scar financing expenses are recovered, and plan to treat their Morton’s Nerve formation. Flo¯Graft® has a standardized they are not supplies or materials entrapment condition. A greater potency of 2 million cells. Flo¯Graft furnished incident to a service. ® percentage of patients who did not Neogenesis The criteria for establishing new ® has a standardized potency receive a Flo¯Graft injection with their device categories are specified at of 1.5 million cells. The applicant conservative treatment required surgery § 419.66(c). The first criterion, at indicated that the product may be used (80 percent versus 7 percent). Patients § 419.66(c)(1), provides that CMS with several surgical procedures, who required surgery had a 95-percent including joint replacement procedures, determines that a device to be included traumatic bone and soft tissue injury, in the category is not appropriately 7 Bregman, Peter. (2014). Addressing Morton’s meniscal repairs, meniscal described by any of the existing Nerve Entrapment Surgically and Non-surgically transplantation, articular cartilage categories or by any category previously with FloGraft.
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success rate when surgery was coupled that the study would guide the use of variety of vial sizes, the largest size with a Flo¯Graft® injection. the product in the future. Other being 18 cc with a cost of $19,925. The next study 8 was a retrospective commenters submitted case studies of Section 419.66(d)(1), the first cost analysis that involved 27 patients who wound care patients treated with significance requirement, provides that were treated for stalled wounds. The Flo¯Graft®. One commenter submitted the estimated average reasonable cost of patients had a broad spectrum of several studies related to amniotic fluid devices in the category must exceed 25 etiologies. Over a 12-month period, the and amniotic membrane-based percent of the applicable APC payment applicant indicated that 96 percent of products; however, none of these amount for the service related to the wounds that had stalled demonstrated studies were specific to the Flo¯Graft® category of devices. We used the highest rapid acceleration towards closure product. priced product for this determination. within a 21-day period when treated Response: We appreciate the The estimated average reasonable cost of ® with Flo¯Graft®. The article commenters’ responses on the $19,925 for Flo¯Graft /Flo¯graft ® ® ® recommended a randomized controlled Flo¯Graft /Flo¯graft Neogenesis product. Neogenesis exceeds the applicable trial (RCT) to confirm the results. The However, the commenters did not APC payment amount for the service applicant also submitted two case provide new empirical evidence that related to the category of devices of studies,910 each involving one patient, addressed our concerns regarding the $1,455 by 1,369 percent ($19,925/$1,455 × which described the use of Flo¯Graft® to evidence of substantial clinical 100 = 1,369 percent). Therefore, we treat distal fibula fracture and tarsal improvement that was submitted with stated in the proposed rule that we ® ® tunnel compression neuropathy. Lastly, the application. These concerns believe Flo¯Graft /Flo¯graft Neogenesis the application included a study 11 included the lack of a clear description meets the first cost significance test. which presented the results from a case of the outcome variable and study The second cost significance test, at study of one patient as well as a population and the lack of statistical § 419.66(d)(2), provides that the retrospective cohort of 34 patients who analysis. The comments also did not estimated average reasonable cost of the received a Brostro¨m-Evans procedure address our concerns that the studies devices in the category must exceed the with the Flo¯Graft® product. In general, submitted with the application were cost of the device-related portion of the the studies submitted lacked a clear case studies, case series, or retrospective APC payment amount for the related description of the outcome variable and cohort studies that lacked random service by at least 25 percent, which study population, and did not include allocation, blinding, and a comparison means that the device cost needs to be statistical analysis. group. The commenters also discussed at least 125 percent of the offset amount studies that did not include the use of (the device-related portion of the APC Based on the evidence submitted, we ® ® stated in the proposed rule that we Flo¯Graft /Flo¯graft Neogenesis and found on the offset list). The average ¯ ® believe there is insufficient data to studies that were still in progress. At reasonable cost of $19,925 for FloGraft / Flo¯graft Neogenesis® exceeds the determine whether Flo¯Graft®/Flo¯graft this time, we have not been able to ® device-related portion of the APC Neogenesis® offers a substantial clinical determine that Flo¯Graft /Flo¯graft ® payment amount of $15,86 by 125,360 improvement over other treatments for Neogenesis represents a substantial percent ($19,925/$15.86) × 100 = wound care. We invited public clinical improvement relative to existing 125,630 percent). Therefore, in the comments on whether the Flo¯Graft®/ therapies currently available for wound proposed rule, we stated that we believe Flo¯graft Neogenesis® meets the care. The third criterion for establishing a that Flo¯Graft®/Flo¯graft Neogenesis® substantial clinical improvement device category, at § 419.66(c)(3), meets the second cost significance test. criterion. requires us to determine that the cost of The third cost significance test, at Comment: Several commenters the device is not insignificant, as § 419.66(d)(3), requires that the described the clinical benefits that they described in § 419.66(d). Section difference between the estimated ¯ ® have observed using the FloGraft 419.66(d) includes three cost average reasonable cost of the devices in product in the treatment of wounds, significance criteria that must each be the category and the portion of the APC bone, and soft tissue repairs. Other met. The applicant provided the payment amount for the device must commenters described their current, following information in support of the exceed 10 percent of the APC payment ongoing studies involving the impact of ® cost significance requirements. The amount for the related service. The Flo¯Graft on rotator cuff healing after applicant stated several CPT codes difference between the average repair. One study described a would be used to report Flo¯Graft®/ reasonable cost of $19,925 for Flo¯Graft®/ randomized single blind study (n=20). Flo¯graft Neogenesis®, including CPT Flo¯graft Neogenesis® and the portion of One commenter was enthusiastic about codes 29826, 29827, 29828, 23473, the APC payment amount for the device the potential impact the product could 23420, 23412, 27605, 27650, 29891, of $15.86 exceeds the APC payment have on improving healing for patients 29888, 29889, 28008, 22551, 22856, amount for the related service of $1,455 with rotator cuff injuries, while another 27179, 29861, and 29862. To meet the by 1,368 percent (($19,925¥$15.86)/ commenter presented a more neutral cost criterion for device pass-through $1,455 × 100 = 1,368 percent). position and stated that he could not payment, a device must pass all three Therefore, in the proposed rule, we confirm that the use of the product tests of the cost criterion for at least one stated that we believe Flo¯Graft®/Flo¯graft would impact the healing, but hoped APC. These CPT codes are assigned to Neogenesis® meets the third cost APCs 5121 through 5125 (Level 1 significance test. 8 Gottleib, et al. FloGraft Rapidly Moves Stalled through Level 5 Musculoskeletal We invited public comments on Wounds Into the Proliferative Phase. ® ® 9 Jacoby, Richard. Case Study 221: Non-surgical Procedures). For our calculations, we whether Flo¯Graft /Flo¯graft Neogenesis Resolution of Distal Fibula Fracture with Flograft used APC 5121 (Level 1 meets the device pass-through payment Implant; 82 YO Male. Musculoskeletal Procedures), which had cost criteria discussed in this section. 10 Jacoby, Richard. Tarsal Tunnel Compression a CY 2016 payment rate of $1,455 and We did not receive any public Neuropathy Case Study Using Flograft. a device offset of $15.86 at the time the comments on this issue. We continue to 11 Maling, Scott. A Case Series: A retrospective application was received. According to believe that Flo¯Graft®/Flo¯graft analysis of 34 patients receiving modified ® ® Bronstom-Evans procedure with Flograft reduce the applicant, the Flo¯Graft /Flo¯graft Neogenesis meets the device pass- time to full mobility by 52%. Neogenesis® product is available in a through payment cost criteria.
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After consideration of the public § 419.66(c)(1), provides that CMS proximal anterolateral aspect of their comments we received, we are not determines that a device to be included nondominant arm. The study approving device pass-through payment in the category is not appropriately population was comprised of volunteers status for the Flo¯Graft®/Flo¯graft described by any of the existing aged between 18 and 67 years with most Neogenesis® product for CY 2018. categories or by any category previously volunteers between the ages of 18 and in effect, and was not being paid for as 30. There were 80 volunteers who (4) KerecisTM Omega3 Wound (Skin an outpatient service as of December 31, received KerecisTM Omega3 Wound and Substitute) 1996. We have not identified an existing 82 volunteers who received porcine SIS Kerecis, LLC submitted an application pass-through payment category that ECM (Oasis). for a new device category for describes KerecisTM Omega3 Wound. The results showed that, at 21 days, transitional pass-through payment The applicant proposed a pass-through 58 (72.5 percent) of the fish skin ADM status for KerecisTM Omega3 Wound. payment device category for KerecisTM group were healed, compared with 46 KerecisTM Omega3 Wound is made from Omega3 Wound with category (56 percent) of the porcine SIS ECM acellular fish skin from wild Atlantic descriptor of ‘‘Piscine skin substitute.’’ group. At 25 days, 62 (77.5 percent) of cod (Gadus morhua) caught in the North We invited public comments on this the fish skin ADM and 53 (65 percent) Atlantic Ocean that is used to regenerate issue. of the porcine SIS ECM group had damaged human tissue in chronic We did not receive any public healed. At the completion of the trial wounds. The applicant claimed that comments on this issue. As we stated (28 days), 76 of the 80 wounds treated there is no disease transmission risk and earlier, we have not identified an with fish skin ADM (95 percent) and 79 noted that the fish skin is not required existing pass-through category that of the 82 wounds treated with porcine to undergo the viral inactivation process describes KerecisTM Omega3 Wound. SIS ECM (96.3 percent) were healed. that the FDA dictates for tissues from Therefore, for the reasons discussed The odds ratio of a fish skin ADM- farm animals. The applicant noted that earlier, we believe KerecisTM Omega3 treated wound being healed as the Omega3 fatty acids offer multiple Wound meets the eligibility criterion. compared with that treated with porcine health benefits, including anti- The second criterion for establishing SIS ECM at any given time point was inflammation. KerecisTM Omega3 a device category, at § 419.66(c)(2), estimated to be 4.75. The difference Wound is supplied as a sterile, single- provides that CMS determines that a between the treatments was statistically use sheet in peel-open pouches. device to be included in the category significant (P = 0.041). The KerecisTM Omega3 Wound does not has demonstrated that it will immunological part of the study was elicit an immune response because the substantially improve the diagnosis or designed to detect autoimmune major antigenic components present treatment of an illness or injury or reactions in those individuals treated within cell membranes are removed in improve the functioning of a malformed with KerecisTM Omega3 Wound. There a gentle manner during processing. body part compared to the benefits of a was no evidence of antibodies forming Unlike mammalian and human sourced device or devices in a previously in the presence of KerecisTM Omega3 products, the fish skin possesses established category or other available Wound. extremely low risk of disease treatment. With regard to the substantial There were issues with this study that transmission and offers no known clinical improvement criterion, the may limit its usefulness to determine cultural or religious constraints for applicant stated that individuals who substantial clinical improvement usage. The fish skin product is both would normally refuse to use skin including the use of nonpatient halal and kosher compatible and avoids substitute products from animal volunteers; studying the healing of potential conflicts with Sikhism and sources, including pigs, cows, horses, biopsy sites rather than actual wounds Hinduism (Vaishnavism). and sheep, would use KerecisTM requiring treatment; and the use of a 1- With respect to the newness criterion Omega3 Wound because it is a fish- month endpoint of care instead of a at § 419.66(b)(1), the applicant received based skin substitute. The applicant also longer period, such as a 6-month FDA clearance for KerecisTM Omega3 asserted that KerecisTM Omega3 Wound endpoint of care. Wound through the premarket provides several beneficial outcomes, The second study 13 was a case series notification section 510(k) process on including faster resolution of the disease study of 18 patients to assess the October 23, 2013 and its June 1, 2016 process compared to similar products, percentage of wound closure area from application was within 3 years of FDA decreased antibiotic use, decreased baseline after 5 weekly fish-skin graft clearance. pain, and reduced amounts of device- applications with at least one ‘‘hard-to- With respect to the eligibility criterion related complications. heal’’ criterion. Patients underwent at § 419.66(b)(3), according to the The applicant cited three studies in application of the fish skin for 5 applicant, KerecisTM Omega3 Wound is support of the application. The first sequential weeks, followed by 3 weeks a skin substitute product that is integral study 12 was a parallel-group, double- of standard care. Wound area, skin to the service provided, is used for one blinded, randomized controlled trial assessments, and pain were analyzed patient only, comes in contact with undertaken to determine if healing time weekly. human skin, and is surgically inserted of whole thickness biopsy wounds The study results showed a 40- into the patient. The applicant also treated with KerecisTM Omega3 Wound percent decrease in wound surface area claimed KerecisTM Omega3 Wound is noninferior to that of wounds treated (P <0.05) and a 48-percent decrease in meets the device eligibility with porcine SIS ECM (Oasis). The wound depth was seen with 5 weekly requirements of § 419.66(b)(4) because it study was an intention-to-treat study. applications of the fish-skin graft and is not an instrument, apparatus, Participants had two 4-mm full secondary dressing (P <0.05). Complete implement, or item for which thickness punch wounds made on the closure was seen in 3 of 18 patients by depreciation and financing expenses are recovered, and it is not a supply or 12 Tumi Baldursson, T, MD, Ph.D. et al. Healing 13 Yang, CK et al. A Prospective, Postmarket, material. Rate and Autoimmune Safety of Full-Thickness Compassionate Clinical Evaluation of a Novel Wounds Treated With Fish Skin Acellular Dermal Acellular Fish-skin Graft Which Contains Omega-3 The criteria for establishing new Matrix Versus Porcine Small-Intestine Submucosa: Fatty Acids for the Closure of Hard-to-heal Lower device categories are specified at A Noninferiority Study; The International Journal of Extremity Chronic Ulcers. Wounds 2016;28(4): 112– § 419.66(c). The first criterion, at Lower Extremity Wounds 2015, Vol. 14(1) 37–43. 118.
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the end of the study phase. This study sourced and not a mammalian or human a substantial clinical improvement did not use a comparator group to sourced skin substitute, provides a through the use of KerecisTM Omega3 measure whether there is substantial significant benefit to beneficiaries with Wound, as compared to the wound care clinical improvement with KerecisTM those objections, as they now have treatments available to this group of Omega3 Wound compared to other skin access to skin substitute products when beneficiaries. Therefore, we determine substitute products. previously skin substitute products may that KerecisTM Omega3 Wound does not The third study 14 was a case series not be available to them. meet the criterion for substantial study of five patients with diabetes Response: The commenter did not clinical improvement. mellitus and complicated wounds in the provide information to demonstrate that The third criterion for establishing a lower limbs with exposed bone KerecisTM Omega3 Wound represents a device category, at § 419.66(c)(3), segments. The five patients had a total substantial clinical improvement requires us to determine that the cost of of seven wounds. Initial debridement relative to other wound care products the device is not insignificant, as occurred in the operating room, currently available on the market. The described in § 419.66(d). Section followed by application of wound commenter did not provide additional 419.66(d) includes three cost matrix and covered with silicone mesh. studies to support its claims of significance criteria that must each be All seven wounds healed and the improvement with acute wound healing met. The applicant provided the patients did not have to have planned and low risk of side effects and adverse following information in support of the amputations on the limbs with the events. The commenter also did not cost significance requirements. With wounds. The mean duration of address the concerns of the first study respect to the cost criterion, the treatment to achieve full closure of the reviewed for this criterion, including applicant stated that KerecisTM Omega3 wound was 25 ± 10 weeks and ranged the use of nonpatient volunteers; Wound would be reported with CPT from 13 to 41 weeks. This study did not studying the healing of biopsy sites codes 15271 through 15278, which have a comparator group to determine if rather than actual wounds requiring cover the application of skin substitute there was substantial clinical treatment; and the use of an unrealistic grafts to different areas of the body for improvement with KerecisTM Omega3 1-month endpoint of care instead of a 6- high-cost skin substitutes. To meet the Wound compared to other skin month endpoint of care. Instead, the cost criterion for device pass-through substitute products. manufacturer simply stated the study payment, a device must pass all three There are no clinical data provided by ‘‘epitomizes’’ substantial clinical tests of the cost criterion for at least one the applicant to suggest that KerecisTM improvement. APC. CPT codes 15271 through 15278 Omega3 Wound provides a substantial The commenter stated that other skin are assigned to either APC 5054 (Level clinical improvement over other similar substitute products that had presented 4 Skin Procedures), with a CY 2016 skin substitute products. We invited less evidence of substantial clinical payment rate of $1,411.21 and a device public comments on whether KerecisTM improvement had previously been offset amount of $4.52, or APC 5055 Omega3 Wound meets the substantial approved for pass-through payment (Level 5 Skin Procedures), with a CY clinical improvement criterion. status. However, we believe that the 2016 payment rate of $2,137.49 and a Comment: One commenter, the commenter may have been referring to device offset amount of $25.44. manufacturer, stated that KerecisTM skin substitutes approved for According to the applicant, the cost of Omega3 Wound significantly improves transitional pass-through payments substitute graft procedures when acute wound healing, nearly eliminates before these products were subject to performed with KerecisTM Omega3 risk from side effects and adverse the transitional pass-through payment Wound is $2,030. events, and provides a skin substitute approval for medical devices. Since CY Section 419.66(d)(1), the first cost option for beneficiaries who have 2015, skin substitutes have been significance requirement, provides that allergic reactions or personal objections evaluated using the medical device the estimated average reasonable cost of to mammalian or human sourced skin pass-through payment process (79 FR devices in the category must exceed 25 substitutes. The commenter referred to a 66885 through 66888), which includes percent of the applicable APC payment study, believed to be the first study the criterion for substantial clinical amount for the service related to the reviewed in the proposed rule,15 and improvement. Applicants must category of devices. The estimated demonstrate that the device under average reasonable cost of $2,030 for stated that it was the largest study TM performed in skin substitute research consideration for pass-through status Kerecis Omega3 Wound exceeds the and that the study showed substantial will substantially improve the diagnosis applicable APC payment amount for the clinical improvement from KerecisTM or treatment of an illness or injury or service related to the category of devices improve the functioning of a malformed of $1,411.21 by 144 percent ($2,030/ Omega3 Wound. The commenter body part compared to the benefits of a $1,411.21 × 100 percent = 144 percent). believed it had submitted more device or devices in a previously Therefore, we stated in the proposed comparative data than skin substitute established category or other available rule that it appears that KerecisTM products that had previously received treatment. The commenter did not Omega3 Wound meets the first cost pass-through payment approval. Lastly, the commenter believed that a provided additional information significance test. showing substantial clinical The second cost significance test, at skin substitute product that eliminates improvement. § 419.66(d)(2), provides that the religious objections to its use, because Finally, the commenter stated that estimated average reasonable cost of the KerecisTM Omega3 Wound is fish KerecisTM Omega3 Wound should meet devices in the category must exceed the the substantial clinical improvement cost of the device-related portion of the 14 Trinh, TT, et al. Marine Omega3 wound matrix for: the treatment of complicated wounds; criterion because it provides a skin APC payment amount for the related Phlebologie 2016; 45: 93–98. substitute option for beneficiaries with service by at least 25 percent, which 15 Tumi Baldursson, T, MD, Ph.D. et al. Healing allergies or personal objections to means that the device cost needs to be Rate and Autoimmune Safety of Full-Thickness mammalian or human sourced products. at least 125 percent of the offset amount Wounds Treated With Fish Skin Acellular Dermal Matrix Versus Porcine Small-Intestine Submucosa: However, the commenter did not (the device-related portion of the APC A Noninferiority Study; The International Journal of provide any studies nor cite any data to found on the offset list). The average Lower Extremity Wounds 2015, Vol. 14(1) 37–43. show that this population would receive reasonable cost of $2,030 for KerecisTM
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Omega3 Wound exceeds the device- and Cellular and Tissue-Based Products The second criterion for establishing related portion of the APC payment (HCT/Ps) regulated solely under section a device category, at § 419.66(c)(2), amount of $4.52 by 44,911 percent 361 of the PHS Act and 21 CFR part provides that CMS determines that a ($2,030/$4.52 × 100 percent = 44,911 1271. For these products, FDA requires, device to be included in the category percent). Therefore, it appears that among other things, that the has demonstrated that it will KerecisTM Omega3 Wound meets the manufacturers register and list their substantially improve the diagnosis or second cost significance test. HCT/Ps with the Center for Biologics treatment of an illness or injury or The third cost significance test, at Evaluation and Research (CBER) within improve the functioning of a malformed § 419.66(d)(3), requires that the 5 days after beginning operations and body part compared to the benefits of a difference between the estimated update their registrations annually. device or devices in a previously average reasonable cost of the devices in Applied Biologics, LLC has a FDA field established category or other available the category and the portion of the APC establishment identifier (FEI) under the treatment. With regard to the substantial payment amount for the device must HHS-FDA-Establishment Registration clinical improvement criterion, the exceed 10 percent of the APC payment and Listing for Human Cells, Tissues, applicant submitted a list of studies in amount for the related service. The and Cellular and Tissue-Based Products the application that showed general difference between the average (HCT/Ps). The applicant submitted an effectiveness of amniotic fluid and reasonable cost of $2,030 for KerecisTM annual registration/listing dated amniotic membrane-based products. Omega3 Wound and the portion of the December 30, 2015. It is not clear when However, these studies were not APC payment amount for the device of the initial CBER filing occurred for the specific to the X–WRAP® product. The ® $4.52 exceeds the APC payment amount X–WRAP product, and therefore, it is applicant also submitted one study 16 for the related service of $1,411 by 144 unclear if the newness criterion for X– that was a retrospective review with ¥ × ® percent (($2,030 $4.52)/$1,411.21) WRAP is met. prospective follow-up of patients (n=8) 100 percent = 144 percent). Therefore, Comment: One commenter, the with recurrent surgical primary cubital we stated in the proposed rule that it manufacturer, supplied information tunnel syndrome (CuTS) who had appears that KerecisTM Omega3 Wound indicating that the initial registration ® undergone at least two previous ulnar meets the third cost significance test. form for X–WRAP was submitted on nerve surgeries before having an ulnar Based on the costs submitted by the February 24, 2015 and validated by FDA neurolysis with X–WRAP® dry amniotic applicant and the calculations noted on June 8, 2015. membrane barrier. The results showed earlier, it appears that KerecisTM Response: Based on the information that the participants experienced Omega3 Wound meets the cost criterion. submitted by the manufacturer, we significant improvement in VAS pain We invited public comments on believe that the product meets the scores, QuickDASH outcome scores, and TM whether Kerecis Omega3 Wound newness criterion at § 419.66(b)(1). grip strength in comparison to these With respect to the eligibility criterion meets the device pass-through payment scores prior to the surgery. Mean VAS criteria discussed in this section. at § 419.66(b)(3), according to the ® improved by 3.5, from 7.3 to 3.8 (P We did not receive any public applicant, X–WRAP is integral to the service provided, is used for one patient <.0001). Mean QuickDASH improved by comments for this section. We confirm 30, from 80 to 50 (P <.0001). Grip that KerecisTM Omega3 Wound meets only, comes in contact with human skin, and is applied in or on a wound strength improved by 25 pounds on the cost criteria for new device average (P <.0001), a mean improvement categories. or other skin lesion. The applicant also ® of 38 percent relative to the contralateral After consideration of the public claimed X–WRAP meets the device side compared with preoperative comments we received, we are not eligibility requirements of § 419.66(b)(4) measurements. Also, none of the approving device pass-through payment because it is not an instrument, patients reported progression or status for KerecisTM Omega3 Wound for apparatus, implement or item for which worsening of their symptoms compared CY 2018. depreciation and financing expenses are recovered, and it is not a supply or with preoperatively. The applicant’s (5) X–WRAP® conclusions from the article were that material furnished incident to a service. ® Applied Biologics, LLC submitted an The criteria for establishing new using the X–WRAP amniotic application for a new device category device categories are specified at membrane with revision neurolysis was for transitional pass-through payment § 419.66(c). The first criterion, at a safe and effective treatment for status for X–WRAP®. X–WRAP® is a § 419.66(c)(1), provides that CMS primary cubital syndrome. The study chorion-free, amnion membrane determines that a device to be included lacked a comparison arm and did not allograft that can be used as a biological in the category is not appropriately include group assignment or blinding of wrap or patch at any surgical site. It is described by any of the existing patients. used as a treatment for surgical or categories or by any category previously Based on the evidence submitted, we believe there are insufficient data to traumatic injury to bone or soft tissue. in effect, and was not being paid for as ® It is used to minimize adhesions, reduce an outpatient service as of December 31, determine whether X–WRAP offers a inflammation, and promote soft tissue 1996. We have not identified an existing substantial clinical improvement over healing. The X–WRAP® is made from pass-through payment device category other treatments for wound care. We ® invited public comments on whether the intermediate amniotic epithelial that describes X–WRAP . The applicant ® layer of the placenta, recovered from a proposed a pass-through device category the X–WRAP meets the substantial Cesarean delivery of pre-screened for X–WRAP® with a category clinical improvement criterion. donors. It is available in a variety of descriptor of ‘‘Amniotic Membrane Soft Comment: Commenters described the clinical benefits that they have observed sizes and is used as a biologic Tissue Allografts’’. We invited public ® augmentation to a variety of orthopedic comments on this issue. using the X–WRAP product in the repairs. We did not receive any public treatment of wounds, bone, and soft With respect to the newness criterion comments on this issue, and at this 16 at § 419.66(b)(1), the applicant indicated time, we have not identified an existing Gaspar, M.P., et al. (2016). Recurrent cubital ® tunnel syndrome treated with revision neurolysis that X–WRAP conforms to the pass-through category that describes X– and amniotic membrane nerve wrapping. Journal of requirements for Human Cells, Tissues, WRAP®. Shoulder and Elbow surgery, 25, 2057–2065.
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tissue repairs. One commenter 363 percent ($5,280/$1,455 × 100 = 363 to exceed 40 percent. Almost all of the submitted several studies related to percent). Therefore, we stated in the procedures assigned to device-intensive amniotic fluid and amniotic membrane- proposed rule that it appears that X– APCs utilize devices, and the device based products; however, none of these WRAP® meets the first cost significance costs for the associated HCPCS codes studies were specific to the X–WRAP® test. exceed the 40-percent threshold. The no product. The second cost significance test, at cost/full credit and partial credit device Response: We appreciate the § 419.66(d)(2), provides that the policy (79 FR 66872 through 66873) commenters’ responses on the X– estimated average reasonable cost of the applies to device-intensive APCs and is WRAP® product. However, the devices in the category must exceed the discussed in detail in section IV.B.4. of commenters did not provide new cost of the device-related portion of the this final rule with comment period. A empirical evidence that addressed our APC payment amount for the related related device policy was the concerns regarding the evidence of service by at least 25 percent, which requirement that certain procedures substantial clinical improvement that means that the device cost needs to be assigned to device-intensive APCs was submitted with the application, at least 125 percent of the offset amount require the reporting of a device code on specifically that this evidence was (the device related portion of the APC the claim (80 FR 70422). For further limited to one retrospective study that found on the offset list). The average background information on the device- lacked a comparison arm and did not reasonable cost of $5,280 for X–WRAP® intensive APC policy, we refer readers include group assignment or blinding of exceeds the device-related portion of the to the CY 2016 OPPS/ASC final rule patients. At this time, we have not been APC payment amount of $15.86 by with comment period (80 FR 70421 ® able to determine that X–WRAP 33,291 percent ($5,280/$15.86) × 100 = through 70426). represents a substantial clinical 33,291 percent). Therefore, we stated in improvement relative to existing 2. HCPCS Code-Level Device-Intensive the proposed rule that it appears that X– Determination therapies currently available for wound WRAP® meets the second cost care. significance test. As stated above, prior to CY 2017, the The third criterion for establishing a The third cost significance test, at device-intensive methodology assigned device category, at § 419.66(c)(3), § 419.66(d)(3), requires that the device-intensive status to all procedures requires us to determine that the cost of difference between the estimated requiring the implantation of a device, the device is not insignificant, as average reasonable cost of the devices in which were assigned to an APC with a described in § 419.66(d). Section the category and the portion of the APC device offset greater than 40 percent. 419.66(d) includes three cost payment amount for the device must Historically, the device-intensive significance criteria that must each be exceed 10 percent of the APC payment designation was at the APC level and met. The applicant provided the amount for the related service. The applied to the applicable procedures following information in support of the difference between the average within that given APC. In the CY 2017 cost significance requirements. The reasonable cost of $5,280 for X–WRAP® OPPS/ASC final rule with comment applicant stated that several CPT codes period (81 FR 79658), we changed our ® and the portion of the APC payment would be used to report X–WRAP , amount for the device of $15.86 exceeds methodology to assign device-intensive status to all procedures that require the including: CPT codes 29826, 29827, the APC payment amount for the related implantation of a device and have an 29828, 23473, 23420, 23412, 27605, service of $1,455 by 361 percent individual HCPCS code-level device 27650, 29891, 29888, 29889, 28008, (($5280¥$15.86)/$1455 × 100 = 361 offset of greater than 40 percent, 22551, 22856, 27179, 29861, 29862, percent). Therefore, we stated in the 15271, 15272, 15273, and 15277. To regardless of the APC assignment. proposed rule that it appears that X– meet the cost criterion for device pass- Under this policy, all procedures with WRAP® meets the third cost through payment, a device must pass all significant device costs (defined as a significance test. three tests for cost threshold for at least device offset of more than 40 percent) We invited public comments on one APC. These CPT codes are assigned are assigned device-intensive status, whether X–WRAP® meets the device to APCs 5121 through 5125 (Level 1 regardless of their APC placement. Also, pass-through payment cost criteria through Level 5 Musculoskeletal we believe that a HCPCS code-level discussed in this section. Procedures) and APCs 5054 and 5055 device offset is, in most cases, a better We did not receive any public (Level 4 and Level 5 Skin Procedures). representation of a procedure’s device comments on this issue. We continue to For our calculations, we used APC 5121 cost than an APC-wide average device believe that X–WRAP® meets the device (Level 1 Musculoskeletal Procedures), offset based on the average device offset pass-through payment cost criteria. which had a CY 2016 payment rate of of all of the procedures assigned to an After consideration of the public $1,455 and a device offset amount of APC. Unlike a device offset calculated at comments we received, we are not $15.86 at the time the application was the APC level, which is a weighted approving device pass-through payment received. According to the applicant, average offset for all devices used in all status for the X–WRAP® product for CY the X–WRAP® product is available in of the procedures assigned to an APC, 2018. several sizes, the largest being 4x8 cm a HCPCS code-level device offset is with a cost of $5,280. B. Device-Intensive Procedures calculated using only claims for a single Section 419.66(d)(1), the first cost HCPCS code. We believe that such a significance requirement, provides that 1. Background methodological change results in a more the estimated average reasonable cost of Under the OPPS, prior to CY 2017, accurate representation of the cost devices in the category must exceed 25 device-intensive APCs were defined as attributable to implantation of a high- percent of the applicable APC payment those APCs with a device offset greater cost device, which ensures consistent amount for the service related to the than 40 percent (79 FR 66795). In device-intensive designation of category of devices. The estimated assigning device-intensive status to an procedures with a significant device average reasonable cost of $5,280 for X– APC, the device costs of all of the cost. Further, we believe a HCPCS code- WRAP® exceeds the applicable APC procedures within the APC were level device offset removes payment amount for the service related calculated and the geometric mean inappropriate device-intensive status to to the category of devices of $1,455 by device offset of all of the procedures had procedures without a significant device
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cost but which are granted such status intensive procedures is included in were performed; (2) the required devices because of APC assignment. Addendum P to this final rule with must be surgically inserted or implanted Under our CY 2017 finalized policy, comment period. devices that remain in the patient’s procedures that have an individual In response to comments received in body after the conclusion of the HCPCS code-level device offset of the CY 2017 OPPS/ASC final rule with procedure (at least temporarily); and (3) greater than 40 percent are identified as comment period, we specified that the device offset amount must be device-intensive procedures and are additional information for our significant, which is defined as subject to all the policies applicable to consideration of an offset percentage exceeding 40 percent of the procedure’s procedures assigned device-intensive higher than the default of 41 percent for mean cost. status under our established new HCPCS codes describing Comment: One commenter supported methodology, including our policies on procedures requiring the implantation the proposed designation of CPT code device edits and device credits. (or in some cases the insertion) of a 28740 (Arthrodesis, midtarsal or Therefore, all procedures requiring the medical device that do not yet have tarsometatarsal, single joint) as a device- implantation of a medical device and associated claims data, such as pricing intensive procedure. A few commenters that have an individual HCPCS code- data or invoices from a device requested that the following HCPCS level device offset of greater than 40 manufacturer, should be directed to the codes be assigned device-intensive percent are subject to the device edit Division of Outpatient Care, Mail Stop status: HCPCS codes 55874 (placeholder and no cost/full credit and partial credit C4–01–26, Centers for Medicare and code 55X87) (Transperineal placement device policies, discussed in sections Medicaid Services, 7500 Security of biodegradable material, peri-prostatic, IV.B.3. and IV.B.4. of this final rule with Boulevard, Baltimore, MD 21244–1850, single or multiple injection(s), including comment period, respectively. or electronically at outpatientpps@ image guidance, when performed); In addition, for new HCPCS codes cms.hhs.gov. Additional information 0275T (Percutaneous laminotomy/ describing procedures requiring the can be submitted prior to issuance of an laminectomy (interlaminar approach) implantation of medical devices that do OPPS/ASC proposed rule or as a public for decompression of neural elements, not yet have associated claims data, in comment in response to an issued (with or without ligamentous resection, the CY 2017 OPPS/ASC final rule with OPPS/ASC proposed rule. Device offset discectomy, facetectomy and/or comment period (81 FR 79658), we percentages will be set in each year’s foraminotomy), any method, under finalized a policy for CY 2017 to apply final rule. indirect image guidance (e.g., device-intensive status with a default We did not propose any changes to fluoroscopic, ct), single or multiple device offset set at 41 percent for new this policy for CY 2018. levels, unilateral or bilateral; lumbar); HCPCS codes describing procedures Comment: Several commenters and 28297 (Correction, hallux valgus requiring the implantation of a medical suggested that CMS use alternate device (bunionectomy), with sesamoidectomy, device that do not yet have associated offset percentage thresholds for when performed; with first metatarsal claims data until claims data are assigning device-intensive status. One of and medial cuneiform joint arthrodesis, available to establish the HCPCS code- those commenters suggested that the any method). level device offset for the procedures. device-intensive designation be given Response: We thank the commenter This default device offset amount of 41 for any specified procedure with a for its support for our proposed percent is not calculated from claims HCPCS code level device offset designation of CPT code 28740. With data; instead, it is applied as a default percentage of greater than 30 percent. respect to the commenters’ request that until claims data are available upon Another commenter suggested that CMS we assign the device-intensive which to calculate an actual device apply the device-intensive designation designation to HCPCS codes 55874, offset for the new code. The purpose of to any procedure for which the 0275T, and 28297, we note that the applying the 41-percent default device individual HCPCS code level device device offset percentage for all three of offset to new codes that describe offset is greater than 40 percent of the these procedures (as identified by the procedures that implant medical procedure’s unadjusted ASC payment above mentioned HCPCS codes or devices is to ensure ASC access for new rate. In addition, one commenter predecessor codes) is not above the 40 procedures until claims data become requested that CMS provide clarification percent threshold, and therefore, these available. However, in certain rare on the criteria for device-intensive procedures are not eligible to be instances, for example, in the case of a procedures, specifically with respect to assigned device-intensive status. very expensive implantable device, we temporarily inserted devices. Comment: Several commenters may temporarily assign a higher offset Response: We thank the commenters suggested that CMS develop a percentage if warranted by additional for their suggestions. However, we mechanism that prevents significant information such as pricing data from a continue to believe that our current payment reductions for device-intensive device manufacturer (81 FR 79658). methodology to assign device-intensive procedures due to wage index Once claims data are available for a new status to all procedures that require the adjustments. procedure requiring the implantation of implantation of a device and have an Response: In response to the a medical device, device-intensive individual HCPCS code-level device commenters’ suggestion that CMS status will be applied to the code if the offset of greater than 40 percent is develop a mechanism that prevents HCPCS code-level device offset is appropriate. With respect to the request significant payment reductions for greater than 40 percent, according to our for clarification about the criteria for device-intensive procedures due to finalized policy of determining device- device-intensive procedures pertaining wage index adjustments, we note that intensive status by calculating the to temporarily inserted devices, we we did not include such a proposal in HCPCS code-level device offset. would like to clarify that device- the CY 2018 proposed rule. However, The full listing of proposed CY 2018 intensive procedures require the we will take this comment into device-intensive procedures was implantation of a device and consideration for future rulemaking. included in Addendum P to the additionally are subject to the following proposed rule (which is available via criteria: (1) All procedures must involve 3. Device Edit Policy the Internet on the CMS Web site). The implantable devices that would be In the CY 2015 OPPS/ASC final rule full listing of the final CY 2018 device- reported if device insertion procedures with comment period (79 FR 66795), we
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finalized a policy and implemented intensive procedures with a device hospitals were instructed to report a claims processing edits that require any offset above 75 percent to be grouped token device charge of less than $1.01. of the device codes used in the previous into an APC together and that all other In cases in which the device being device-to-procedure edits to be present procedures be excluded (both inserted is an upgrade (either of the on the claim whenever a procedure code nondevice-intensive procedures and same type of device or to a different assigned to any of the APCs listed in device-intensive procedures that have a type of device) with a full credit for the Table 5 of the CY 2015 OPPS/ASC final device offset percentage below 75 device being replaced, hospitals were rule with comment period (the CY 2015 percent). instructed to report as the device charge device-dependent APCs) is reported on Response: As we stated in the CY the difference between the hospital’s the claim. In addition, in the CY 2016 2015 OPPS/ASC final rule with usual charge for the device being OPPS/ASC final rule with comment comment period (79 FR 66794), we implanted and the hospital’s usual period (80 FR 70422), we modified our continue to believe that the elimination charge for the device for which it previously existing policy and applied of device-to-procedure edits and received full credit. In CY 2008, we the device coding requirements procedure-to-device edits is appropriate expanded this payment adjustment exclusively to procedures that require due to the experience hospitals now policy to include cases in which the implantation of a device that are have in coding and reporting these hospitals receive partial credit of 50 assigned to a device-intensive APC. In claims fully. More specifically, for the percent or more of the cost of a specified the CY 2016 OPPS/ASC final rule with more costly devices, we believe the C– device. Hospitals were instructed to comment period, we also finalized our APCs will reliably reflect the cost of the append the ‘‘FC’’ modifier to the policy that the claims processing edits device if charges for the device are procedure code that reports the service are such that any device code, when included anywhere on the claim. We provided to furnish the device when reported on a claim with a procedure remind commenters that, under our they receive a partial credit of 50 assigned to a device-intensive APC current policy, hospitals are still percent or more of the cost of the new (listed in Table 42 of the CY 2016 OPPS/ expected to adhere to the guidelines of device. We refer readers to the CY 2008 ASC final rule with comment period (80 correct coding and append the correct OPPS/ASC final rule with comment FR 70422)) will satisfy the edit. device code to the claim when period for more background information In the CY 2017 OPPS/ASC final rule applicable. We also remind commenters on the ‘‘FB’’ and ‘‘FC’’ modifiers with comment period (81 FR 79658 that, as with all other items and services payment adjustment policies (72 FR through 79659), we changed our policy recognized under the OPPS, we expect 66743 through 66749). for CY 2017 and subsequent years to hospitals to code and report their costs apply the CY 2016 device coding In the CY 2014 OPPS/ASC final rule appropriately, regardless of whether with comment period (78 FR 75005 requirements to the newly defined there are claims processing edits in (individual HCPCS code-level device through 75007), beginning in CY 2014, place. In addition, we remind we modified our policy of reducing offset greater than 40 percent) device- commenters that, under our current intensive procedures. For CY 2017 and OPPS payment for specified APCs when policy, the APC assignment of a device- a hospital furnishes a specified device subsequent years, we also specified that intensive procedure has no bearing on any device code, when reported on a without cost or with a full or partial the procedure’s device-intensive credit. For CY 2013 and prior years, our claim with a device-intensive designation. With respect to the procedure, will satisfy the edit. In policy had been to reduce OPPS commenter’s request for an additional payment by 100 percent of the device addition, we created HCPCS code C1889 policy specifically for device-intensive to recognize devices furnished during a offset amount when a hospital furnishes procedures that have a device offset a specified device without cost or with device-intensive procedure that are not percentage above 75 percent, for the described by a specific Level II HCPCS a full credit and by 50 percent of the reasons stated above in this comment device offset amount when the hospital Category C-code. Reporting HCPCS code response, we do not believe that such a C1889 with a device-intensive receives partial credit in the amount of policy is needed. procedure will satisfy the edit requiring 50 percent or more of the cost for the a device code to be reported on a claim 4. Adjustment to OPPS Payment for No specified device. For CY 2014, we with a device-intensive procedure. Cost/Full Credit and Partial Credit reduced OPPS payment, for the We did not propose any changes to Devices applicable APCs, by the full or partial this policy for CY 2018. credit a hospital receives for a replaced Comment: One commenter requested a. Background device. Specifically, under this that CMS restore the device-to- To ensure equitable OPPS payment modified policy, hospitals are required procedure and procedure-to-device when a hospital receives a device to report on the claim the amount of the edits. Another commenter requested without cost or with full credit, in CY credit in the amount portion for value that CMS adopt an additional policy for 2007, we implemented a policy to code ‘‘FD’’ (Credit Received from the device-intensive procedures that have a reduce the payment for specified Manufacturer for a Replaced Medical device offset percentage above 75 device-dependent APCs by the Device) when the hospital receives a percent, that would implement device- estimated portion of the APC payment credit for a replaced device that is 50 to-procedure and procedure-to-device attributable to device costs (that is, the percent or greater than the cost of the edits for all such procedures (having a device offset) when the hospital receives device. For CY 2014, we also limited the device offset percentage above 75 a specified device at no cost or with full OPPS payment deduction for the percent) and would only utilize claims credit (71 FR 68071 through 68077). applicable APCs to the total amount of that passed those edits for establishing Hospitals were instructed to report no the device offset when the ‘‘FD’’ value the geometric mean cost and the cost/full credit device cases on the code appears on a claim. For CY 2015, HCPCS-level device offset for those claim using the ‘‘FB’’ modifier on the we continued our existing policy of procedures. Also, as part of this line with the procedure code in which reducing OPPS payment for specified commenter’s suggested new policy, the the no cost/full credit device is used. In APCs when a hospital furnishes a commenter requested that CMS only cases in which the device is furnished specified device without cost or with a allow clinically similar, device- without cost or with full credit, full or partial credit and to use the three
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criteria established in the CY 2007 methodology) to calculate the payment For CY 2018, in the CY 2018 OPPS/ OPPS/ASC final rule with comment rate for the implantable miniature ASC proposed rule (82 FR 33620), we period (71 FR 68072 through 68077) for telescope procedure described by CPT proposed to continue with our current determining the APCs to which our CY code 0308T (Insertion of ocular policy of establishing the payment rate 2015 policy will apply (79 FR 66872 telescope prosthesis including removal for any device-intensive procedure that through 66873). In the CY 2016 OPPS/ of crystalline lens or intraocular lens is assigned to a clinical APC with fewer ASC final rule with comment period (80 prosthesis), which is the only code than 100 total claims for all procedures FR 70424), we finalized our policy to no assigned to APC 5494 (Level 4 in the APC based on calculations using longer specify a list of devices to which Intraocular Procedures) (80 FR 70388). the median cost instead of the geometric the OPPS payment adjustment for no We note that, as stated in the CY 2017 mean cost. For CY 2018, this policy cost/full credit and partial credit OPPS/ASC proposed rule (81 FR 45656), would continue to apply only to a devices would apply and instead apply we proposed to reassign the procedure procedure described by CPT code 0308T this APC payment adjustment to all described by CPT code 0308T to APC in APC 5495 because this APC is the replaced devices furnished in 5495 (Level 5 Intraocular Procedures) only clinical APC containing a device- conjunction with a procedure assigned for CY 2017, but it would be the only intensive procedure with fewer than 100 to a device-intensive APC when the procedure code assigned to APC 5495. total claims in the APC. As we have hospital receives a credit for a replaced The payment rates for a procedure stated before (81 FR 79660), we believe specified device that is 50 percent or described by CPT code 0308T that this approach will help to mitigate greater than the cost of the device. (including the predecessor HCPCS code significant year-to-year payment rate fluctuations while preserving accurate b. Policy for No Cost/Full Credit and C9732) were $15,551 in CY 2014, claims data-based payment rates for Partial Credit Devices $23,084 in CY 2015, and $17,551 in CY 2016. The procedure described by CPT low-volume device-intensive In the CY 2017 OPPS/ASC final rule code 0308T is a high-cost device- procedures. The CY 2018 proposed rule with comment period (81 FR 79659 intensive surgical procedure that has a median cost for the procedure described through 79660), for CY 2017 and very low volume of claims (in part by CPT code 0308T was approximately subsequent years, we finalized our because most of the procedures $17,643.75. The proposed CY 2018 policy to reduce OPPS payment for described by CPT code 0308T are payment rate (calculated using the device-intensive procedures, by the full performed in ASCs), and we believe that median cost and the claims that or partial credit a provider receives for the median cost is a more appropriate reported the device consistent with our a replaced device, when a hospital measure of the central tendency for device edit policy for device intensive furnishes a specified device without purposes of calculating the cost and the procedures) was approximately cost or with a full or partial credit. payment rate for this procedure because $16,963.69. Under our current policy, hospitals the median cost is impacted to a lesser Comment: Some commenters continue to be required to report on the degree than the geometric mean cost by supported CMS’ proposal to base claim the amount of the credit in the more extreme observations. We stated payment on the median cost instead of amount portion for value code ‘‘FD’’ that, in future rulemaking, we would the geometric mean cost for any device- when the hospital receives a credit for consider proposing a general policy for intensive procedure that is assigned to a replaced device that is 50 percent or the payment rate calculation for very an APC with fewer than 100 total claims. Other commenters requested greater than the cost of the device. low-volume device-intensive APCs (80 In addition, for CY 2017 and that CMS limit the impact of geometric FR 70389). subsequent years, we finalized our mean cost reductions on payment rates policy to use the following three criteria For CY 2017, we proposed and for low-volume procedures by a certain for determining the procedures to which finalized a payment policy for low- percentage to ensure payment stability our final policy applies: (1) All volume device-intensive procedures for low-volume procedures. procedures must involve implantable that is similar to the policy applied to Response: We thank commenters for devices that would be reported if device the procedure described by CPT code their support. With respect to the insertion procedures were performed; 0308T in CY 2016. In the CY 2017 commenters’ request to limit the impact (2) the required devices must be OPPS/ASC final rule with comment of the geometric mean cost reductions surgically inserted or implanted devices period (81 FR 79660 through 79661), we on payment rates for low volume that remain in the patient’s body after established our current policy that the procedures by a certain percentage, we the conclusion of the procedure (at least payment rate for any device-intensive disagree with commenters that such a temporarily); and (3) the procedure procedure that is assigned to a clinical percentage-based limitation is must be device intensive; that is, the APC with fewer than 100 total claims necessary. We continue to believe our device offset amount must be for all procedures in the APC be current policy—establishing the significant, which is defined as calculated using the median cost instead payment rate for any device-intensive exceeding 40 percent of the procedure’s of the geometric mean cost, for the procedure that is assigned to a clinical mean cost. reasons described above for the policy APC with fewer than 100 total claims We did not propose any changes to applied to the procedure described by for all procedures in the APC based on this policy for CY 2018 and did not CPT code 0308T in CY 2016. The CY calculations using the median cost receive any public comments on this 2017 final rule geometric mean cost for instead of the geometric mean cost— policy. the procedure described by CPT code will help to mitigate significant year-to- 0308T (based on 19 claims containing year payment rate fluctuations while 5. Payment Policy for Low-Volume the device HCPCS C-code in accordance preserving accurate claims data-based Device-Intensive Procedures with the device-intensive edit policy) payment rates for low-volume device- For CY 2016, we used our equitable was approximately $21,302, and the intensive procedures. adjustment authority under section median cost was approximately After consideration of the public 1833(t)(2)(E) of the Act and used the $19,521. The final CY 2017 payment comments we received, we are median cost (instead of the geometric rate (calculated using the median cost) finalizing our proposal, without mean cost per our standard is approximately $18,984. modification, that the payment rate for
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any device-intensive procedure that is at least 2 years, but not more than 3 not more than 3 years, after the payment assigned to a clinical APC with fewer years, after the payment was first made was first made for the product as a than 100 total claims for all procedures for the product as a hospital outpatient hospital outpatient service under in the APC be calculated using the service under Medicare Part B. CY 2018 Medicare Part B. Our current policy is median cost instead of the geometric pass-through drugs and biologicals and to accept pass-through applications on a mean cost. The CY 2018 final rule their designated APCs are assigned quarterly basis and to begin pass- median cost for the procedure described status indicator ‘‘G’’ in Addenda A and through payments for newly approved by CPT code 0308T is $17,550.18. The B to this final rule with comment period pass-through drugs and biologicals on a final CY 2018 payment rate (calculated (which are available via the Internet on quarterly basis through the next using updated median cost and the the CMS Web site). available OPPS quarterly update after claims that reported the device Section 1833(t)(6)(D)(i) of the Act the approval of a product’s pass-through consistent with our device edit policy specifies that the pass-through payment status. However, prior to CY 2017, we for device-intensive procedures) is amount, in the case of a drug or expired pass-through status for drugs $17,560.07. biological, is the amount by which the and biologicals on an annual basis amount determined under section through notice-and-comment V. OPPS Payment Changes for Drugs, 1842(o) of the Act for the drug or rulemaking (74 FR 60480). In the CY Biologicals, and Radiopharmaceuticals biological exceeds the portion of the 2017 OPPS/ASC final rule with A. OPPS Transitional Pass-Through otherwise applicable Medicare OPD fee comment period (81 FR 79662), we Payment for Additional Costs of Drugs, schedule that the Secretary determines finalized a policy change, beginning Biologicals, and Radiopharmaceuticals is associated with the drug or biological. with pass-through drugs and biologicals The methodology for determining the newly approved in CY 2017 and 1. Background pass-through payment amount is set subsequent calendar years, to allow for Section 1833(t)(6) of the Act provides forth in regulations at 42 CFR 419.64. a quarterly expiration of pass-through for temporary additional payments or These regulations specify that the pass- payment status for drugs and biologicals ‘‘transitional pass-through payments’’ through payment equals the amount to afford a pass-through payment period for certain drugs and biologicals. determined under section 1842(o) of the that is as close to a full 3 years as Throughout this final rule with Act minus the portion of the APC possible for all pass-through drugs, comment period, the term ‘‘biological’’ payment that CMS determines is biologicals, and radiopharmaceuticals. is used because this is the term that associated with the drug or biological. This change eliminated the variability appears in section 1861(t) of the Act. A Section 1847A of the Act establishes of the pass-through payment eligibility ‘‘biological’’ as used in this final rule the average sales price (ASP) period, which previously varied based with comment period includes (but is methodology, which is used for on when a particular application was not necessarily limited to) a ‘‘biological payment for drugs and biologicals initially received. We adopted this product’’ or a ‘‘biologic’’ as defined in described in section 1842(o)(1)(C) of the change for pass-through approvals the Public Health Service Act. As Act furnished on or after January 1, beginning on or after CY 2017, to allow, enacted by the Medicare, Medicaid, and 2005. The ASP methodology, as applied on a prospective basis, for the maximum SCHIP Balanced Budget Refinement Act under the OPPS, uses several sources of pass-through payment period for each of 1999 (BBRA) (Pub. L. 106–113), this data as a basis for payment, including pass-through drug without exceeding pass-through payment provision the ASP, the wholesale acquisition cost the statutory limit of 3 years. requires the Secretary to make (WAC), and the average wholesale price 3. Drugs and Biologicals With Expiring additional payments to hospitals for: (AWP). In this final rule with comment Pass-Through Payment Status in CY Current orphan drugs, as designated period, the term ‘‘ASP methodology’’ 2017 under section 526 of the Federal Food, and ‘‘ASP-based’’ are inclusive of all Drug, and Cosmetic Act; current drugs data sources and methodologies In the CY 2018 OPPS/ASC proposed and biologicals and brachytherapy described therein. Additional rule (82 FR 33621), we proposed that sources used in cancer therapy; and information on the ASP methodology the pass-through payment status of 19 current radiopharmaceutical drugs and can be found on the CMS Web site at: drugs and biologicals would expire on biologicals. ‘‘Current’’ refers to those http://www.cms.gov/Medicare/ December 31, 2017, as listed in Table 21 types of drugs or biologicals mentioned Medicare-Fee-for-Service-Part-B-Drugs/ of the proposed rule (82 FR 33622). All above that are hospital outpatient McrPartBDrugAvgSalesPrice/ of these drugs and biologicals will have services under Medicare Part B for index.html. received OPPS pass-through payment which transitional pass-through The pass-through application and for at least 2 years and no more than 3 payment was made on the first date the review process for drugs and biologicals years by December 31, 2017. These hospital OPPS was implemented. is described on the CMS Web site at: drugs and biologicals were approved for Transitional pass-through payments http://www.cms.gov/Medicare/ pass-through payment status on or also are provided for certain ‘‘new’’ Medicare-Fee-for-Service-Payment/ before January 1, 2016. In accordance drugs and biologicals that were not HospitalOutpatientPPS/passthrough_ with the policy finalized last year and being paid for as an HOPD service as of payment.html. described above, pass-through payment December 31, 1996 and whose cost is status for drugs and biologicals newly ‘‘not insignificant’’ in relation to the 2. 3-Year Transitional Pass-Through approved in CY 2017 and subsequent OPPS payments for the procedures or Payment Period for All Pass-Through years will expire on a quarterly basis, services associated with the new drug or Drugs, Biologicals, and with a pass-through payment period as biological. For pass-through payment Radiopharmaceuticals and Quarterly close to 3 years as possible. With the purposes, radiopharmaceuticals are Expiration of Pass-Through Status exception of those groups of drugs and included as ‘‘drugs.’’ As required by As required by statute, transitional biologicals that are always packaged statute, transitional pass-through pass-through payments for a drug or when they do not have pass-through payments for a drug or biological biological described in section payment status (specifically, anesthesia described in section 1833(t)(6)(C)(i)(II) 1833(t)(6)(C)(i)(II) of the Act can be drugs; drugs, biologicals, and of the Act can be made for a period of made for a period of at least 2 years, but radiopharmaceuticals that function as
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supplies when used in a diagnostic test service (42 CFR 419.64(c)(2)), the in one of these trials could have begun or procedure (including diagnostic commenter believed that an erroneous appropriate billing Medicare for the radiopharmaceuticals, contrast agents, payment by Medicare should not have amyloid PET procedures and associated and stress agents); and drugs and triggered the start of pass-through Amyloid PET tracers beginning April 2, biologicals that function as supplies payment for Amyvid in 2015. In 2014. when used in a surgical procedure), our addition, the commenter asserted that Based on our claims analysis, we standard methodology for providing expiration of pass-through payment found that HCPCS code A9586 was payment for drugs and biologicals with status for Amyvid prior to completion of billed by hospital providers 14 times in expiring pass-through payment status in the CED trial will adversely affect the CY 2015, with 1 claim being paid. Based an upcoming calendar year is to trial results. The commenter requested on our review of provider enrollment in determine the product’s estimated per that, if CMS finalized expiration of pass- the CED trials, it appears that this paid day cost and compare it with the OPPS through payment status as proposed, Medicare claim from CY 2015 was drug packaging threshold for that CMS create a new APC for PET submitted from a CED clinical trial calendar year (which is $120 for CY procedures with Amyvid to avoid participant and not paid in error as the 2018), as discussed further in section violating the 2 times rule—which commenter suggests. According to V.B.2. of this final rule with comment provides that items and services within section 1833(t)(6)(C)(i)(II) of the Act and period. In the CY 2018 OPPS/ASC an APC group cannot be considered the regulations at 42 CFR 419.66(g), the proposed rule (82 FR 33622), we comparable with respect to the use of pass-through payment eligibility period proposed that if the estimated per day resources if the highest median cost (or begins on the first date on which pass- cost for the drug or biological is less mean cost, if elected by the Secretary) through payment is made. Because there than or equal to the applicable OPPS for an item or service in the APC group is a paid claim from CY 2015, the pass- drug packaging threshold, we would is more than 2 times greater than the through payment period for HCPCS package payment for the drug or lowest median cost (or mean cost, if code A9586 began in CY 2015. biological into the payment for the elected by the Secretary) for an item or Therefore, based on the CY 2015 paid associated procedure in the upcoming service within the same APC group. The claim for HCPCS code A9586 as a calendar year. If the estimated per day commenter stated that the median cost hospital outpatient service, which cost of the drug or biological is greater of Amyvid is approximately $2,756, triggered the start of the pass-through than the OPPS drug packaging over two times the median cost of the payment period, we are expiring pass- threshold, we proposed to provide PET scan procedure. through payment status on December separate payment at the applicable One commenter, a manufacturer of 31, 2017. From the start of the pass- relative ASP-based payment amount another radiopharmaceutical, through payment period through (which was proposed at ASP+6 percent recommended that CMS allow for those December 31, 2017, Medicare will have for CY 2018, and is finalized at ASP+6 products whose pass-through payment provided an OPPS pass-through percent for CY 2018, as discussed status will expire after a period of at payment for at least 2 years and no more further in section V.B.3. of this final rule least 2 years and no more than 3 years than 3 years by December 31, 2017. with comment period). to expire as proposed, as a matter of Extending pass-through payment status Comment: Several commenters applying policy consistently. into CY 2018 would cause pass-through responded to the proposed expiration of Several commenters recommended payments for HCPCS code A9586 to pass-through status for HCPCS code that CMS allow products covered by extend into a fourth year, thereby A9586 (Florbetapir f18) on December Medicare in the context of coverage exceeding the pass-through payment 31, 2017. (We note that the brand name with evidence development (CED) period authorized by section for the radiopharmaceutical described clinical trial to retain their pass-through 1833(t)(6)(C)(i)(II) of the Act. by HCPCS code A9586 is Amyvid®. status for the duration of the CED trial. In addition, regarding the Amyvid is a FDA-approved radioactive Response: CMS issued a Medicare commenters’ concern that expiration of diagnostic agent for Positron Emission National Coverage Determination (NCD) pass-through payment status for Tomography (PET) imaging of the brain on September 27, 2013, which allows Amyvid, and subsequent packaging of it to estimate beta-amyloid neuritic plaque conditional coverage of amyloid PET as a ‘‘policy-packaged’’ drug, will skew density in adult patients with cognitive under CED. Currently, there are three trial results (presumably because impairment who are being evaluated for Medicare-approved amyloid PET CED providers will not receive an ASP-based Alzheimer’s Disease and other causes of trials. The first CED trial was approved payment), we disagree, given that cognitive decline. Amyvid was on April 2, 2014. The second CED trial analysis of CY 2016 claims data across approved for drug pass-through was approved on March 3, 2015. The different sites of care shows that the vast payment status effective January 1, third CED trial was approved January 5, majority of billings for HCPCS code 2015.) 2016. Information on these clinical trials A9586 is concentrated in the physician One commenter, the manufacturer of is available on the CMS amyloid PET office and the independent diagnostic Amyvid, urged CMS to extend pass- Web page available via the Internet at: testing facility (IDTF) setting. Further, through payment status for another year https://www.cms.gov/Medicare/ we note that hospitals are not precluded on the basis that CMS could not have Coverage/Coverage-with-Evidence- from billing for HCPCS code A9586 in paid a legitimately billed claim for Development/Amyloid-PET.html. The the context of a CED trial once its pass- Amyvid in CY 2015, given the effective date of Medicare billing for through payment status expires. We also manufacturer’s assertion regarding CED CED trial sites is the CMS approval date. note that the payment for HCPCS A9586 trial sites’ dates of approval and start CMS has provided billing instructions would be reflected in the payment rate dates for patient enrollment. In for providers and practitioner that for the associated procedure. addition, while the commenter specify proper coding for clinical trial With respect to the request that we acknowledged that the period of drug claims. For example, providers and create a new APC for PET procedures and biological pass-through payment practitioner must report certain with Amyvid, we do not believe it is status starts on the first date on which diagnosis codes, procedure codes, appropriate, prudent, or practicable to payment is made for the drug or modifiers, and a national clinical trial create unique APCs for specific drugs or biological as an outpatient hospital number. Therefore, providers enrolled biologicals or other individual items
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that are furnished with a particular accordance with section 1833(t)(6) of new information that would cause us to procedure or procedures. We disagree the Act. change our position that Omidria is a with the commenter’s assertion that Comment: Several commenters drug that functions as a surgical supply. packaging of Amyvid with the requested that CMS not package Therefore, we are not addressing these associated PET procedure described by payment for Omidria® (described by comments in this final rule with CPT code 78814 (Pet image w/ct lmtd) HCPCS code C9447) upon expiration of comment period. However, in the creates a 2 times rule violation in APC pass-through payment status on proposed rule, we did solicit comments 5594 (Level 4 Nuclear Medicine) (we December 31, 2017, and continue to pay on packaging policies generally, refer readers to section III.B. of this final separately for the drug at ASP+6 including drugs that function as a rule with comment period for percent. One commenter, the surgical supply, and will take responses discussion of 2 times rule) and believe manufacturer of Omidria, reiterated to the comment solicitation, along with that the commenter may have many previous arguments (81 FR 79667) these commenters’ recommendations misunderstood the application of the 2 for why CMS should dispense with and suggestions, into consideration in times rule. Specifically, we note that, in classifying Omidria as drug that future rulemaking. determining the APCs with a 2 times functions as a surgical supply when Comment: Commenters urged CMS to rule violation, we do not consider the used in a surgical procedure. Specially, apply quarterly expiration of drug pass- cost of an individual packaged item that the commenter made the following through payment to drugs and may be furnished with a procedure or arguments: biologicals first added to the pass- • service, but rather the geometric mean The language used to construct the through payment list in CYs 2015 and cost of the service (which includes ‘‘packaging as a surgical supply’’ policy 2016 that would otherwise transition off aggregate cost of packaged items that is overly broad and not consistent with pass-through payment in less than 3 may be furnished with a procedure). Congressional intent that requires years. Commenters suggested CMS Moreover, we disagree with the clinically comparable APC groups. CMS could apply the quarterly expiration of commenter’s statement that the median has not defined surgery or provided a pass-through payment policy to devices cost of Amyvid is approximately $2,756. rationale for applying different approved for pass-through payment While it is correct that the CY 2017 packaging policies to surgery than status in CY 2015 or 2016 because it pass-through payment for Amyvid is would be applied to other drugs with would not cause harm to providers or therapeutic indications; beneficiaries. As stated earlier in this $2,756, the pass-through payment rate • of ASP+6 percent is not indicative of the Mischaracterization of drugs used section, one commenter suggested that cost incurred by hospitals to acquire, in surgery as ‘‘supplies’’, given CMS allow for those products whose store, handle, and dispense Amyvid. regulatory requirements that apply to pass-through payment status will expire Our analysis of the updated CY 2016 drugs. The FDA-approved label after a period of at least 2 years and no claims data used for CY 2018 ratesetting indicates its specific use in intraocular more than 3 years to expire as proposed, for this CY 2018 OPPS/ASC final rule procedures; as a matter of applying policy • Packaging Omidria and other drugs with comment period shows that the consistently. as surgical supplies creates barriers to Response: As finalized in the CY 2017 median cost of Amyvid is $1,275.75, access, especially in ASC settings, low- OPPS/ASC final rule with comment which when combined with the volume HOPDs, and hospitals with low period (81 FR 79662), the quarterly aggregate cost of packaged items that percentage of insured patients expiration of pass-through payment may be furnished with CPT code 78814, (presumably because providers may policy applies to drugs and biologicals would not create a 2 times rule choose lower cost alternatives because newly approved for pass-through violation. separate payment would no longer be payment in CY 2017. We note that, even With respect to the commenters’ made); prior to the policy change adopted in request that we allow drug or biological • Packaging Omidria and other drugs CY 2017 rulemaking, the Agency’s prior pass-through payment status for as surgical supplies may affect quality of policy practice of making drug pass- products covered by CED for the care improvements and patient through payments for a minimum of 2 duration of the CED trial, we reiterate outcomes; and years, but not more than 3 years, was that the statute limits the period of pass- • Packaging drugs as ‘‘surgical consistent with statutory authority. through payment eligibility to at least 2 supplies’’ interferes with physician Further, once a drug’s pass-through years, but no more than 3 years, after the discretion and is inconsistent with the payment status period expires, its costs product’s first payment as a hospital principles that guide packaging under are packaged into the associated outpatient service under Medicare Part the OPPS. procedure(s) with which it is billed, and B. As such, we are unable to extend A few commenters requested that accordingly, reversing past expirations pass-through payment status beyond 3 CMS consider a narrow exception to the of pass-through payment would years. ‘‘drug as a supply’’ packaging policy to potentially cause payment rates Finally, with respect to the enable separate payment for Omidria. established for a prior year for certain commenter’s support of our proposal to Response: We have addressed many services to be incorrect. finalize the expiration of pass-through of these comments in prior rulemaking. We agree with the commenter who payment status as proposed for We refer readers to the CY 2017 OPPS/ stated that we should expire the drug- consistent policy application, we agree ASC final rule with comment period for pass-through payment status for drugs with the commenter. a detailed discussion on why we believe and biologicals as proposed, to allow for In summary, we are finalizing our Omidria is a drug that functions as a consistent application of our policy. proposal to expire pass-through surgical supply (81 FR 79668). We did After consideration of the public payment status for HCPCS code A9586 not propose any policy changes to the comments we received, we are on December 31, 2017. Because pass- criteria applied to a drug that functions finalizing our proposal, without through payment was effective in CY as a surgical supply when used in a modification, to expire the pass-through 2015, HCPCS code A9586 will have had surgical procedure in the CY 2018 payment status of the 19 drugs and pass-through payment status for at least OPPS/ASC proposed rule, nor do we biologicals listed in Table 69 below on 2 years but no more than 3 years in believe the commenters provided any December 31, 2017.
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TABLE 69—DRUGS AND BIOLOGICALS FOR WHICH PASS-THROUGH PAYMENT STATUS EXPIRES DECEMBER 31, 2017
Final CY 2018 CY 2018 Final Pass-through HCPCS code CY 2018 long descriptor status CY 2018 payment indicator APC effective date
A9586 ...... Florbetapir f18, diagnostic, per study dose, up to 10 millicuries ...... N N/A 01/01/2015 C9447 ...... Injection, phenylephrine and ketorolac, 4 ml vial ...... N N/A 01/01/2015 J0596 ...... Injection, c-1 esterase inhibitor (human), Ruconest, 10 units ...... K 9445 04/01/2015 J0695 ...... Injection, ceftolozane 50 mg and tazobactam 25 mg ...... K 9452 04/01/2015 J0875 ...... Injection, dalbavancin, 5 mg ...... K 1823 01/01/2015 J1833 ...... Injection, isavuconazonium sulfate, 1 mg ...... K 9456 10/01/2015 J2407 ...... Injection, oritavancin, 10 mg ...... K 1660 01/01/2015 J2502 ...... Injection, pasireotide long acting, 1 mg ...... K 9454 07/01/2015 J2547 ...... Injection, peramivir, 1 mg ...... K 9451 04/01/2015 J2860 ...... Injection, siltuximab, 10 mg ...... K 9455 07/01/2015 J3090 ...... Injection, tedizolid phosphate, 1 mg ...... K 1662 01/01/2015 J7313 ...... Injection, fluocinolone acetonide intravitreal implant, 0.01 mg ...... K 9450 04/01/2015 J8655 ...... Netupitant (300 mg) and palonosetron (0.5 mg) ...... K 9448 04/01/2015 J9032 ...... Injection, belinostat, 10 mg ...... K 1658 01/01/2015 J9039 ...... Injection, blinatumomab, 1 mcg ...... K 9449 04/01/2015 J9271 ...... Injection, pembrolizumab, 1 mg ...... K 1490 01/01/2015 J9299 ...... Injection, nivolumab, 1 mg ...... K 9453 07/01/2015 Q4172 ...... PuraPly, and PuraPly Antimicrobial, any type, per square centimeter ...... N N/A 01/01/2015 Q9950 ...... Injection, sulfur hexafluoride lipid microsphere, per ml ...... N N/A 10/01/2015
The final packaged or separately percent, equivalent to the payment rate rule with comment period (70 FR 68632 payable status of each of these drugs or these drugs and biologicals would through 68635). biologicals is listed in Addendum B to receive in the physician’s office setting For CY 2018, consistent with our CY this final rule with comment period in CY 2018. We proposed that a $0 pass- 2017 policy for diagnostic and (which is available via the Internet on through payment amount would be paid therapeutic radiopharmaceuticals, we the CMS Web site). for pass-through drugs and biologicals proposed to provide payment for both under the CY 2018 OPPS because the diagnostic and therapeutic 4. Drugs, Biologicals, and difference between the amount radiopharmaceuticals that are granted Radiopharmaceuticals With New or authorized under section 1842(o) of the pass-through payment status based on Continuing Pass-Through Payment Act, which was proposed at ASP+6 the ASP methodology. As stated earlier, Status in CY 2018 percent, and the portion of the for purposes of pass-through payment, In the CY 2018 OPPS/ASC proposed otherwise applicable OPD fee schedule we consider radiopharmaceuticals to be rule (82 FR 33622), we proposed to that the Secretary determines is drugs under the OPPS. Therefore, if a continue pass-through payment status appropriate, which was proposed at diagnostic or therapeutic in CY 2018 for 38 drugs and biologicals. ASP+6 percent, is $0. radiopharmaceutical receives pass- None of these drugs and biologicals will In the case of policy-packaged drugs through payment status during CY 2018, have received OPPS pass-through (which include the following: we proposed to follow the standard ASP payment for at least 2 years and no more Anesthesia drugs; drugs, biologicals, methodology to determine the pass- than 3 years by December 31, 2017. and radiopharmaceuticals that function through payment rate that drugs receive These drugs and biologicals, which as supplies when used in a diagnostic under section 1842(o) of the Act, which were approved for pass-through test or procedure (including contrast was proposed at ASP+6 percent. If ASP payment status between January 1, agents, diagnostic radiopharmaceuticals, data are not available for a 2016, and July 1, 2017, were listed in and stress agents); and drugs and radiopharmaceutical, we proposed to Table 22 of the proposed rule (82 FR biologicals that function as supplies provide pass-through payment at 33623). The APCs and HCPCS codes for when used in a surgical procedure), we WAC+6 percent, the equivalent these drugs and biologicals approved for proposed that their pass-through payment provided to pass-through pass-through payment status through payment amount would be equal to payment drugs and biologicals without July 1, 2017 were assigned status ASP+6 percent for CY 2018 because, if ASP information. If WAC information indicator ‘‘G’’ in Addenda A and B to not for their pass-through payment also is not available, we proposed to the proposed rule (which are available status, payment for these products provide payment for the pass-through via the Internet on the CMS Web site). would be packaged into the associated radiopharmaceutical at 95 percent of its Section 1833(t)(6)(D)(i) of the Act sets procedure. most recent AWP. the amount of pass-through payment for In addition, we proposed to continue Comment: Commenters supported pass-through drugs and biologicals (the to update pass-through payment rates CMS’ proposal to provide payment at pass-through payment amount) as the on a quarterly basis on the CMS Web ASP+6 percent for drugs, biologicals, difference between the amount site during CY 2018 if later quarter ASP contrast agents, and authorized under section 1842(o) of the submissions (or more recent WAC or radiopharmaceuticals that are granted Act and the portion of the otherwise AWP information, as applicable) pass-through payment status. applicable OPD fee schedule that the indicate that adjustments to the Response: We appreciate the Secretary determines is associated with payment rates for these pass-through commenters’ support. the drug or biological. For CY 2018, we drugs or biologicals are necessary. For a After consideration of the public proposed to continue to pay for pass- full description of this policy, we refer comments we received, we are through drugs and biologicals at ASP+6 readers to the CY 2006 OPPS/ASC final finalizing our proposal to provide
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payment for drugs, biologicals, the pass-through payment rate that not available, we will provide payment diagnostic and therapeutic drugs receive under section 1842(o) of for the pass-through payment radiopharmaceuticals, and contrast the Act, which is ASP+6 percent. If ASP radiopharmaceutical at 95 percent of its agents that are granted pass-through data are not available for a most recent AWP. payment status based on the ASP radiopharmaceutical, we will provide The 50 drugs and biologicals that methodology. If a diagnostic or pass-through payment at WAC+6 continue to have pass-through payment therapeutic radiopharmaceutical percent, the equivalent payment status for CY 2018 or have been granted receives pass-through payment status provided to pass-through payment drugs pass-through payment status as of during CY 2018, we will follow the and biologicals without ASP January 2018 are shown in Table 70 standard ASP methodology to determine information. If WAC information also is below.
TABLE 70—DRUGS AND BIOLOGICALS WITH PASS-THROUGH PAYMENT STATUS IN CY 2018
Pass-through CY 2017 CY 2018 CY 2018 CY 2018 payment HCPCS code HCPCS code CY 2018 long descriptor status APC effective indicator date
A9515 ...... A9515 ...... Choline C 11, diagnostic, per study dose ...... G 9461 04/01/2016 A9587 ...... A9587 ...... Gallium ga-68, dotatate, diagnostic, 0.1 millicurie ...... G 9056 01/01/2017 A9588 ...... A9588 ...... Fluciclovine f-18, diagnostic, 1 millicurie ...... G 9052 01/01/2017 C9140 ...... J7210 ...... Injection, Factor VIII (antihemophilic factor, recombinant) G 9043 01/01/2017 (Afstyla), 1 I.U. C9460 ...... C9460 ...... Injection, cangrelor, 1 mg ...... G 9460 01/01/2016 C9482 ...... C9482 ...... Injection, sotalol hydrochloride, 1 mg ...... G 9482 10/01/2016 C9483 ...... J9022 ...... Injection, atezolizumab, 10 mg ...... G 9483 10/01/2016 C9484 ...... J1428 ...... Injection, eteplirsen, 10 mg ...... G 9484 04/01/2017 C9485 ...... J9285 ...... Injection, olaratumab, 10 mg ...... G 9485 04/01/2017 C9486 ...... J1627 ...... Injection, granisetron extended release, 0.1 mg ...... G 9486 04/01/2017 C9488 ...... C9488 ...... Injection, conivaptan hydrochloride, 1 mg ...... G 9488 04/01/2017 C9489 ...... J2326 ...... Injection, nusinersen, 0.1 mg ...... G 9489 07/01/2017 C9490 ...... J0565 ...... Injection, bezlotoxumab, 10 mg ...... G 9490 07/01/2017 C9491 ...... J9023 ...... Injection, avelumab, 10 mg ...... G 9491 10/01/2017 C9492 ...... C9492 ...... Injection, durvalumab, 10 mg ...... G 9492 10/01/2017 C9493 ...... C9493 ...... Injection, edaravone, 1 mg ...... G 9493 10/01/2017 C9494 ...... J2350 ...... Injection, ocrelizumab, 1 mg ...... G 9494 10/01/2017 J0570 ...... J0570 ...... Buprenorphine implant, 74.2 mg ...... G 9058 01/01/2017 J1942 ...... J1942 ...... Injection, aripiprazole lauroxil, 1 mg ...... G 9470 04/01/2016 J2182 ...... J2182 ...... Injection, mepolizumab, 1 mg ...... G 9473 04/01/2016 J2786 ...... J2786 ...... Injection, reslizumab, 1 mg ...... G 9481 10/01/2016 J2840 ...... J2840 ...... Injection, sebelipase alfa, 1 mg ...... G 9478 07/01/2016 J7179 ...... J7179 ...... Injection, von willebrand factor (recombinant), (Vonvendi), G 9059 01/01/2017 1 i.u. vwf:rco. J7202 ...... J7202 ...... Injection, Factor IX, albumin fusion protein (recombinant), G 9171 10/01/2016 Idelvion, 1 i.u. J7207 ...... J7207 ...... Injection, Factor VIII (antihemophilic factor, recombinant) G 1844 04/01/2016 PEGylated, 1 I.U. J7209 ...... J7209 ...... Injection, Factor VIII (antihemophilic factor, recombinant) G 1846 04/01/2016 (Nuwiq), per i.u. J7322 ...... J7322 ...... Hyaluronan or derivative, Hymovis, for intra-articular injec- G 9471 04/01/2016 tion, 1 mg. J7328 ...... J7328 ...... Hyaluronan or derivative, Gelsyn-3, for intra-articular in- G 1862 04/01/2017 jection, 0.1 mg. J7342 ...... J7342 ...... Instillation, ciprofloxacin otic suspension, 6 mg ...... G 9479 07/01/2016 J7503 ...... J7503 ...... Tacrolimus, extended release, (envarsus xr), oral, 0.25 G 1845 04/01/2016 mg. J9034 ...... J9034 ...... Injection, bendamustine hcl (Bendeka), 1 mg ...... G 1861 01/01/2017 J9145 ...... J9145 ...... Injection, daratumumab, 10 mg ...... G 9476 07/01/2016 J9176 ...... J9176 ...... Injection, elotuzumab, 1 mg ...... G 9477 07/01/2016 J9205 ...... J9205 ...... Injection, irinotecan liposome, 1 mg ...... G 9474 04/01/2016 J9295 ...... J9295 ...... Injection, necitumumab, 1 mg ...... G 9475 04/01/2016 J9325 ...... J9325 ...... Injection, talimogene laherparepvec, 1 million plaque G 9472 04/01/2016 forming units (PFU). J9352 ...... J9352 ...... Injection, trabectedin, 0.1 mg ...... G 9480 07/01/2016 N/A ...... J9203 ...... Injection, gemtuzumab ozogamicin, 0.1 mg ...... G 9495 01/01/2018 Q5101 ...... Q5101 ...... Injection, Filgrastim (G–CSF), Biosimilar, 1 microgram ..... G 1822 01/01/2016 Q5102 ...... Q5102 ...... Injection, Infliximab, Biosimilar, 10 mg ...... G 1847 04/01/2017 Q9982 ...... Q9982 ...... Flutemetamol F18, diagnostic, per study dose, up to 5 G 9459 01/01/2016 millicuries. Q9983 ...... Q9983 ...... Florbetaben F18, diagnostic, per study dose, up to 8.1 G 9458 01/01/2016 millicuries. Q9989 ...... J3358 ...... Ustekinumab, for Intravenous Injection, 1 mg ...... G 9487 04/01/2017 N/A ...... C9014 ...... Injection, cerliponase alfa, 1 mg ...... G 9014 01/01/2018 N/A ...... C9015 ...... Injection, c-1 esterase inhibitor (human), Haegarda, 10 G 9015 01/01/2018 units.
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TABLE 70—DRUGS AND BIOLOGICALS WITH PASS-THROUGH PAYMENT STATUS IN CY 2018—Continued
Pass-through CY 2017 CY 2018 CY 2018 CY 2018 payment HCPCS code HCPCS code CY 2018 long descriptor status APC effective indicator date
N/A ...... C9016 ...... Injection, triptorelin extended release, 3.75 mg ...... G 9016 01/01/2018 N/A ...... C9024 ...... Injection, liposomal, 1 mg daunorubicin and 2.27 mg G 9302 01/01/2018 cytarabine. N/A ...... C9028 ...... Injection, inotuzumab ozogamicin, 0.1 mg ...... G 9028 01/01/2018 N/A ...... C9029 ...... Injection, guselkumab, 1 mg ...... G 9029 01/01/2018 N/A ...... J7345 ...... Aminolevulinic acid hcl for topical administration, 10% gel, G 9301 01/01/2018 10 mg.
5. Provisions for Reducing Transitional 2018, as we did in CY 2017, we stress agents, and pass-through skin Pass-Through Payments for Policy- proposed to continue to apply the same substitutes as we did in CY 2017. Packaged Drugs, Biologicals, and policy packaged offset policy to Radiopharmaceuticals To Offset Costs payment for pass-through diagnostic TABLE 71—APCS TO WHICH A POL- Packaged Into APC Groups radiopharmaceuticals, pass-through ICY-PACKAGED DRUG OR RADIO- Under the regulations at 42 CFR contrast agents, pass-through stress PHARMACEUTICAL OFFSET ARE AP- agents, and pass-through skin 419.2(b), nonpass-through drugs, PLICABLE IN CY 2018 substitutes. The proposed APCs to biologicals, and radiopharmaceuticals which a payment offset may be that function as supplies when used in CY 2018 CY 2018 applicable for pass-through diagnostic APC APC title a diagnostic test or procedure are radiopharmaceuticals, pass-through packaged in the OPPS. This category contrast agents, pass-through stress Diagnostic Radiopharmaceutical includes diagnostic agents, and pass-through skin radiopharmaceuticals, contrast agents, 5591 ...... Level 1 Nuclear Medicine and substitutes were identified in Table 23 stress agents, and other diagnostic Related Services. of the proposed rule. drugs. Also under 42 CFR 419.2(b), 5592 ...... Level 2 Nuclear Medicine and Comment: A few commenters Related Services. nonpass-through drugs and biologicals requested that CMS separate the costs of that function as supplies in a surgical 5593 ...... Level 3 Nuclear Medicine and diagnostic radiopharmaceuticals and Related Services. procedure are packaged in the OPPS. stress agents from the ‘‘packaged drug 5594 ...... Level 4 Nuclear Medicine and This category includes skin substitutes cost’’ in the APC offset file published Related Services. and other surgical-supply drugs and with the yearly proposed and final biologicals. As described earlier, section rules. Contrast Agent 1833(t)(6)(D)(i) of the Act specifies that Response: We thank the commenter 5571 ...... Level 1 Imaging with Contrast. the transitional pass-through payment for this recommendation. However, we amount for pass-through drugs and 5572 ...... Level 2 Imaging with Contrast. do not believe that the suggested change 5573 ...... Level 3 Imaging with Contrast. biologicals is the difference between the is necessary at this time. The offset amount paid under section 1842(o) of amount is the portion of each APC Stress Agent the Act and the otherwise applicable payment rate that could reasonably be OPD fee schedule amount. Because a attributed to the cost of a predecessor 5722 ...... Level 2 Diagnostic Tests and Re- payment offset is necessary in order to contrast agent, diagnostic lated Services. provide an appropriate transitional radiopharmaceutical, or stress agent 5593 ...... Level 3 Nuclear Medicine and Related Services. pass-through payment, we deduct from when considering a new contrast agent, the pass-through payment for policy diagnostic radiopharmaceutical, or Skin Substitute packaged drugs, biologicals, and stress agent for pass-through payment radiopharmaceuticals an amount and has no bearing on APC assignment. 5054 ...... Level 4 Skin Procedures. reflecting the portion of the APC The exact data used to calculate all of 5055 ...... Level 5 Skin Procedures. payment associated with predecessor the proposed and final payment rates, products in order to ensure no duplicate including the associated offset amounts, We also are finalizing our proposal to payment is made. This amount for this CY 2018 OPPS final rule with continue to post annually on the CMS reflecting the portion of the APC comment are available for purchase Web site at: https://www.cms.gov/ payment associated with predecessor under a CMS data use agreement Medicare/Medicare-Fee-for-Service- products is called the payment offset. through the CMS Web site available via Payment/HospitalOutpatientPPS/ The payment offset policy applies to the Internet at: https://www.cms.gov/ Annual-Policy-Files.html a file that all policy packaged drugs, biologicals, Research-Statistics-Data-and-Systems/ contains the APC offset amounts that and radiopharmaceuticals. For a full Files-for-Order/IdentifiableDataFiles/ will be used for that year for purposes description of the payment offset policy index.html. of both evaluating cost significance for as applied to diagnostic After consideration of the public candidate pass-through payment device radiopharmaceuticals, contrast agents, comments we received, we are categories and drugs and biologicals and stress agents, and skin substitutes, we finalizing our proposal, without establishing any appropriate APC offset refer readers to the discussion in the CY modification, for CY 2018, to continue amounts. Specifically, the file will 2016 OPPS/ASC final rule with to apply the same policy-packaged offset continue to provide the amounts and comment period (80 FR 70430 through policy to payment for pass-through percentages of APC payment associated 70432). In the CY 2018 OPPS/ASC diagnostic radiopharmaceuticals, pass- with packaged implantable devices, proposed rule (82 FR 33624), for CY through contrast agents, pass-through policy-packaged drugs, and threshold
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packaged drugs and biologicals for every all nonpass-through drugs and 2016 hospital claims data to determine OPPS clinical APC. biologicals that are not policy packaged, their per day cost. we calculated, on a HCPCS code- We proposed to package items with a B. OPPS Payment for Drugs, Biologicals, specific basis, the per day cost of all per day cost less than or equal to $120, and Radiopharmaceuticals Without drugs, biologicals, and therapeutic and identify items with a per day cost Pass-Through Payment Status radiopharmaceuticals (collectively greater than $120 as separately payable. 1. Criteria for Packaging Payment for called ‘‘threshold-packaged’’ drugs) that Consistent with our past practice, we Drugs, Biologicals, and had a HCPCS code in CY 2016 and were cross-walked historical OPPS claims Radiopharmaceuticals paid (via packaged or separate payment) data from the CY 2016 HCPCS codes that were reported to the CY 2017 a. Packaging Threshold under the OPPS. We used data from CY 2016 claims processed before January 1, HCPCS codes that we displayed in In accordance with section 2017 for this calculation. However, we Addendum B to the proposed rule 1833(t)(16)(B) of the Act, the threshold did not perform this calculation for (which is available via the Internet on for establishing separate APCs for those drugs and biologicals with the CMS Web site) for proposed payment of drugs and biologicals was multiple HCPCS codes that include payment in CY 2018. set to $50 per administration during CYs different dosages, as described in Comment: Many commenters 2005 and 2006. In CY 2007, we used the section V.B.1.d. of the proposed rule, or requested that CMS eliminate the four quarter moving average Producer for the following policy-packaged items threshold packaging policy and pay Price Index (PPI) levels for that we proposed to continue to package separately for all drugs and biologicals Pharmaceutical Preparations in CY 2018: Anesthesia drugs; drugs, described by a unique HCPCS code. (Prescription) to trend the $50 threshold biologicals, and radiopharmaceuticals Several commenters expressed concern forward from the third quarter of CY that function as supplies when used in with the annual increases in the drug 2005 (when the Pub. L. 108–173 a diagnostic test or procedure; and drugs packaging threshold, citing that yearly mandated threshold became effective) to and biologicals that function as supplies increases have outpaced conversion the third quarter of CY 2007. We then when used in a surgical procedure. factor updates and place a financial rounded the resulting dollar amount to In order to calculate the per day costs burden on hospitals. A few commenters the nearest $5 increment in order to for drugs, biologicals, and therapeutic recommended that CMS delay the determine the CY 2007 threshold radiopharmaceuticals to determine their proposed increase in the packaging amount of $55. Using the same proposed packaging status in CY 2018, threshold for drugs or freeze the methodology as that used in CY 2007 we used the methodology that was packaging threshold at the current level (which is discussed in more detail in described in detail in the CY 2006 OPPS ($110). the CY 2007 OPPS/ASC final rule with proposed rule (70 FR 42723 through Response: We have received and comment period (71 FR 68085 through 42724) and finalized in the CY 2006 addressed similar comments in prior 68086)), we set the packaging threshold OPPS final rule with comment period rules and most recently in CY 2017 for establishing separate APCs for drugs (70 FR 68636 through 68638). For each OPPS/ASC final rule with comment (81 and biologicals at $110 for CY 2017 (81 drug and biological HCPCS code, we FR 79666). As we stated in the CY 2007 FR 79665). used an estimated payment rate of OPPS/ASC final rule with comment Following the CY 2007 methodology, ASP+6 percent (which is the payment period (71 FR 68086), we believe that for this CY 2018 OPPS/ASC final rule rate we proposed for separately payable packaging certain items is a with comment period, we used the most drugs and biologicals for CY 2018, as fundamental component of a recently available four quarter moving discussed in more detail in section prospective payment system, that average PPI levels to trend the $50 V.B.2.b. of the proposed rule) to updating the packaging threshold of $50 threshold forward from the third quarter calculate the CY 2018 proposed rule per for the CY 2005 OPPS is consistent with of CY 2005 to the third quarter of CY day costs. We used the manufacturer industry and government practices, and 2018 and rounded the resulting dollar submitted ASP data from the fourth that the PPI for Prescription Drugs is an amount ($118.52) to the nearest $5 quarter of CY 2016 (data that were used appropriate mechanism to gauge Part B increment, which yielded a figure of for payment purposes in the physician’s drug inflation. Therefore, because $120. In performing this calculation, we office setting, effective April 1, 2017) to packaging is a fundamental component used the most recent forecast of the determine the proposed rule per day of a prospective payment system that quarterly index levels for the PPI for cost. continues to provide important Pharmaceuticals for Human Use As is our standard methodology, for flexibility and efficiency in the delivery (Prescription) (Bureau of Labor Statistics CY 2018, we proposed to use payment of high quality hospital outpatient series code WPUSI07003) from CMS’ rates based on the ASP data from the services, we are not adopting the Office of the Actuary. first quarter of CY 2017 for budget commenters’ recommendations to pay Therefore, for this CY 2018 OPPS/ neutrality estimates, packaging separately for all drugs, biologicals, and ASC final rule with comment period, determinations, impact analyses, and radiopharmaceuticals for CY 2018, using the CY 2007 OPPS methodology, completion of Addenda A and B to the eliminate the packaging threshold, and we are finalizing a packaging threshold proposed rule (which are available via delay updating the packaging threshold for CY 2018 of $120. the Internet on the CMS Web site) or freeze the packaging threshold at because these were the most recent data $110. b. Packaging of Payment for HCPCS available for use at the time of After consideration of the public Codes That Describe Certain Drugs, development of the proposed rule. comments we received, and consistent Certain Biologicals, and Therapeutic These data also were the basis for drug with our methodology for establishing Radiopharmaceuticals Under the Cost payments in the physician’s office the packaging threshold using the most Threshold (‘‘Threshold-Packaged setting, effective April 1, 2017. For recent PPI forecast data, we are adopting Drugs’’) items that did not have an ASP-based a CY 2018 packaging threshold of $120. In the CY 2018 OPPS/ASC proposed payment rate, such as some therapeutic Our policy during previous cycles of rule (82 FR 33625), to determine the radiopharmaceuticals, we used their the OPPS has been to use updated ASP proposed CY 2018 packaging status for mean unit cost derived from the CY and claims data to make final
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determinations of the packaging status payable) in CY 2017. These established c. Policy Packaged Drugs, Biologicals, of HCPCS codes for drugs, biologicals, policies have not changed for many and Radiopharmaceuticals and therapeutic radiopharmaceuticals years and are the same as described in As mentioned briefly earlier, in the for the OPPS/ASC final rule with the CY 2016 OPPS/ASC final rule with OPPS, we package several categories of comment period. We note that it is also comment period (80 FR 70434). drugs, biologicals, and our policy to make an annual packaging Specifically, for CY 2018, consistent radiopharmaceuticals, regardless of the determination for a HCPCS code only with our historical practice, we cost of the products. Because the when we develop the OPPS/ASC final proposed to apply the following policies products are packaged according to the rule with comment period for the to these HCPCS codes for drugs, policies in 42 CFR 419.2(b), we refer to update year. Only HCPCS codes that are biologicals, and therapeutic these packaged drugs, biologicals, and identified as separately payable in the radiopharmaceuticals whose radiopharmaceuticals as ‘‘policy- final rule with comment period are relationship to the drug packaging packaged’’ drugs, biologicals, and subject to quarterly updates. For our threshold changes based on the updated radiopharmaceuticals. These policies calculation of per day costs of HCPCS drug packaging threshold and on the are either longstanding or based on codes for drugs and biologicals in this final updated data: • longstanding principles and inherent to CY 2018 OPPS/ASC final rule with HCPCS codes for drugs and the OPPS and are as follows: comment period, we used ASP data biologicals that were paid separately in • Anesthesia, certain drugs, from the first quarter of CY 2017, which CY 2017 and that were proposed for biologicals, and other pharmaceuticals; is the basis for calculating payment rates separate payment in CY 2018, and that medical and surgical supplies and for drugs and biologicals in the then have per day costs equal to or less equipment; surgical dressings; and physician’s office setting using the ASP than the CY 2018 final rule drug devices used for external reduction of methodology, effective July 1, 2017, packaging threshold, based on the fractures and dislocations along with updated hospital claims data updated ASPs and hospital claims data (§ 419.2(b)(4)); from CY 2016. We note that we also used for this CY 2018 final rule, would • Intraoperative items and services used these data for budget neutrality continue to receive separate payment in (§ 419.2(b)(14)); estimates and impact analyses for this CY 2018. • Drugs, biologicals, and • CY 2018 OPPS/ASC final rule with HCPCS codes for drugs and radiopharmaceuticals that function as comment period. biologicals that were packaged in CY supplies when used in a diagnostic test Payment rates for HCPCS codes for 2017 and that were proposed for or procedure (including but not limited separately payable drugs and biologicals separate payment in CY 2018, and that to, diagnostic radiopharmaceuticals, included in Addenda A and B for this then have per day costs equal to or less contrast agents, and pharmacologic final rule with comment period are than the CY 2018 final rule drug stress agents (§ 419.2(b)(15)); and based on ASP data from the third packaging threshold, based on the • Drugs and biologicals that function quarter of CY 2017. These data are the updated ASPs and hospital claims data as supplies when used in a surgical basis for calculating payment rates for used for this CY 2018 final rule, would procedure (including, but not limited to, drugs and biologicals in the physician’s remain packaged in CY 2018. skin substitutes and similar products • office setting using the ASP HCPCS codes for drugs and that aid wound healing and implantable methodology, effective October 1, 2017. biologicals for which we proposed biologicals) (§ 419.2(b)(16)). These payment rates will be updated in packaged payment in CY 2018 but then The policy at § 419.2(b)(16) is broader the January 2018 OPPS update, based on have per day costs greater than the CY than that at § 419.2(b)(14). As we stated the most recent ASP data to be used for 2018 final rule drug packaging in the CY 2015 OPPS/ASC final rule physician’s office and OPPS payment as threshold, based on the updated ASPs with comment period: ‘‘We consider all of January 1, 2018. For items that do not and hospital claims data used for this items related to the surgical outcome currently have an ASP-based payment CY 2018 final rule, would receive and provided during the hospital stay in rate, we proposed to recalculate their separate payment in CY 2018. which the surgery is performed, mean unit cost from all of the CY 2016 We did not receive any public including postsurgical pain claims data and updated cost report comments on our proposal to management drugs, to be part of the information available for this CY 2018 recalculate the mean unit cost for items surgery for purposes of our drug and final rule with comment period to that do not currently have an ASP-based biological surgical supply packaging determine their final per day cost. payment rate from all of the CY 2016 policy’’ (79 FR 66875). The category Consequently, as stated in the CY claims data and updated cost report described by § 419.2(b)(15) is large and 2018 OPPS/ASC proposed rule (82 FR information available for this CY 2018 includes diagnostic 33625), the packaging status of some final rule with comment period to radiopharmaceuticals, contrast agents, HCPCS codes for drugs, biologicals, and determine their final per day cost. We stress agents, and some other products. therapeutic radiopharmaceuticals in the also did not receive any public The category described by § 419.2(b)(16) proposed rule may be different from the comments on our proposal to continue includes skin substitutes and some same drug HCPCS code’s packaging to follow the established policies other products. We believe it is status determined based on the data initially adopted for the CY 2005 OPPS important to reiterate that cost used for this final rule with comment (69 FR 65780), when the packaging consideration is not a factor when period. Under such circumstances, in status of some HCPCS codes for drugs, determining whether an item is a the CY 2018 OPPS/ASC proposed rule, biologicals, and therapeutic surgical supply (79 FR 66875). we proposed to continue to follow the radiopharmaceuticals in the proposed We did not make any proposals to established policies initially adopted for rule may be different from the same revise our policy-packaged drug policy. the CY 2005 OPPS (69 FR 65780) in drug HCPCS code’s packaging status We solicited public comment on the order to more equitably pay for those determined based on the data used for general OPPS packaging policies as drugs whose cost fluctuates relative to the final rule with comment period. discussed in section II.A.3.d. of this the proposed CY 2018 OPPS drug Therefore, for CY 2018, we are finalizing final rule with comment period. packaging threshold and the drug’s these two CY 2018 proposals without Comment: Several commenters payment status (packaged or separately modification. requested that CMS revise its packaging
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policies to allow for separate payment required a diagnostic their associated nuclear medicine for Cysview® (hexaminolevulinate HCl), radiopharmaceutical to be present on procedures would be inconsistent which is described by HCPCS code the same claim as a nuclear medicine among nuclear medicine procedures. C9275, according to the ASP procedure for payment under the OPPS The foundation of a system of relative methodology. The commenters also to be made. The edits were in place weights is the relativity of the costs of provided recommendations in response between CY 2008 and CY 2014 (78 FR all services to one another, as derived to the general comment solicitation on 75033). We believe the period of time in from a standardized system that uses packaging under the OPPS. which the edits were in place was standardized inputs and a consistent Response: We appreciate the sufficient for hospitals to gain methodology. Adoption of a ratesetting comments in response to the packaging experience reporting procedures methodology for certain APCs solicitation, including feedback on the involving radiolabeled products and to containing nuclear medicine procedures ‘‘packaging as a supply’’ policy and will grow accustomed to ensuring that they that is different from the standard APC consider these recommendations in code and report charges so that their ratesetting methodology would future rulemaking. However, because claims fully and appropriately reflect undermine this relativity. For this we did not propose to modify our the costs of those radiolabeled products. reason, we do not believe it would be policy-packaged drug policy for drugs As with all other items and services appropriate to use external pricing that function as a supply when used in recognized under the OPPS, we expect information in place of the costs derived a diagnostic test or procedure, or receive hospitals to code and report their costs from the claims and Medicare cost information from commenters that appropriately, regardless of whether report data because to do so would caused us to believe that Cysview® is there are claims processing edits in distort the relativity that is fundamental not a drug that functions as a supply place. to the integrity of the OPPS. when used in a diagnostic test or Comment: One commenter With respect to the request to provide procedure and, accordingly, should be recommended that CMS use ASP an additional payment for paid separately, payment for HCPCS information, when voluntarily reported radiopharmaceuticals that are granted code C9275 will continue to be by the manufacturer, as a better price pass-through payment status, the packaged with the primary procedure in input to account for the packaged costs commenter did not provide information CY 2018. of the diagnostic radiopharmaceuticals on what expenses or costs incurred by Comment: Numerous commenters and more appropriately reflect providers would be covered by an requested that CMS pay separately for hospitals’ actual acquisition costs. This additional payment. We continue to Exparel®, an FDA approved post- commenter also requested that CMS believe that a single payment is surgical analgesia drug. Several provide an additional payment for appropriate for radiopharmaceuticals commenters, including many radiopharmaceuticals that are granted with pass-through payment status in CY commenters who received care from the pass-through payment status. 2018 and that the payment rate of same provider, shared their experience Response: We disagree with ASP+6 percent is appropriate to provide with receiving Exparel® after their knee commenter’s recommendation that we payment for both the replacement surgery and urged CMS to use voluntarily-reported ASP radiopharmaceutical’s acquisition cost pay hospitals and/or physicians for the information for nonpass-through and any associated nuclear medicine use of Exparel®. payment for radiopharmaceuticals as an handling and compounding costs. Response: We refer readers to the CY approximation of their acquisition cost. 2015 OPPS/ASC final rule with Packaging hospital costs based on d. High Cost/Low Cost Threshold for comment (79 FR 66874 and 66875) for hospital claims data is how all the costs Packaged Skin Substitutes a detailed discussion on our decision to of all packaged items are factored into In the CY 2014 OPPS/ASC final rule package Exparel® (bupivacaine payment rates for associated procedures with comment period (78 FR 74938), we liposome injectable suspension) under the OPPS, and we do not believe unconditionally packaged skin described by HCPCS code C9290 it is appropriate to depart from that substitute products into their associated (Injection, bupivicaine liposome, 1 mg) policy for radiopharmaceuticals. surgical procedures as part of a broader as a drug that functions as a supply in Radiopharmaceuticals for which we policy to package all drugs and a surgical procedure. Because we did have not established a separate APC will biologicals that function as supplies not propose to modify our packaged receive packaged payment under the when used in a surgical procedure. As drug policy for drugs that function as a OPPS. We provide payment for part of the policy to finalize the surgical supply when used in a surgical diagnostic radiopharmaceuticals based packaging of skin substitutes, we also procedure, and believe payment for on a proxy for average acquisition cost. finalized a methodology that divides the HCPCS code C9290 is appropriately We continue to believe that the line- skin substitutes into a high cost group packaged with the primary surgical item estimated cost for a diagnostic and a low cost group, in order to ensure procedure, payment for HCPCS code radiopharmaceutical in our claims data adequate resource homogeneity among C9290 will remain packaged in CY is a reasonable approximation of average APC assignments for the skin substitute 2018. acquisition and preparation and application procedures (78 FR 74933). Comment: A few commenters handling costs for diagnostic Skin substitutes assigned to the high recommended that CMS continue to radiopharmaceuticals. cost group are described by HCPCS apply the nuclear medicine procedure In addition, we note that not all codes 15271 through 15278. Skin to radiolabeled product edits to ensure manufacturers would be able to submit substitutes assigned to the low cost that all packaged costs are included on ASP data through the established ASP group are described by HCPCS codes nuclear medicine claims in order to reporting methodology. Therefore, if we C5271 through C5278. Geometric mean establish appropriate payment rates in were to use ASP data to package the costs for the various procedures are the future. costs of some diagnostic calculated using only claims for the skin Response: We do not agree with radiopharmaceuticals, but use hospital substitutes that are assigned to each commenters that we should reinstate the claims data for others, our group. Specifically, claims billed with nuclear medicine procedure to methodologies for packaging the costs of HCPCS code 15271, 15273, 15275, or radiolabeled product edits, which diagnostic radiopharmaceuticals into 15277 are used to calculate the
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geometric mean costs for procedures exceeds either the MUC threshold or the several skin substitutes from the high assigned to the high cost group, and PDC threshold to the high cost group. In cost group to the low cost group which, claims billed with HCPCS code C5271, addition, as described in more detail under current payment rates, can be a C5273, C5275, or C5277 are used to later in this section, for CY 2018, as for difference of approximately $1,000 in calculate the geometric mean costs for CY 2017, we proposed to assign any the payment amount for the same procedures assigned to the low cost skin substitute with an MUC or a PDC procedure. In addition, these group (78 FR 74935). that does not exceed either the MUC stakeholders were concerned that the Each of the HCPCS codes described threshold or the PDC threshold to the inclusion of cost data from skin above are assigned to one of the low cost group. For CY 2018, we substitutes with pass-through payment following three skin procedure APCs proposed that any skin substitute status in the MUC and PDC calculations according to the geometric mean cost for product that was assigned to the high would artificially inflate the thresholds. the code: APC 5053 (Level 3 Skin cost group in CY 2017 would be Skin substitute stakeholders requested Procedures) (HCPCS codes C5271, assigned to the high cost group for CY that CMS consider alternatives to the C5275, and C5277); APC 5054 (Level 4 2018, regardless of whether it exceeds or current methodology used to calculate Skin Procedures) (HCPCS codes C5273, falls below the CY 2018 MUC or PDC the MUC and PDC thresholds and also 15271, 15275, and 15277); or APC 5055 threshold. requested that CMS consider whether it (Level 5 Skin Procedures) (HCPCS code For this CY 2018 OPPS/ASC final rule might be appropriate to establish a new 15273). In CY 2017, the payment rate for with comment period, consistent with cost group in between the low cost APC 5053 (Level 3 Skin Procedures) was the methodology as established in the group and the high cost group to allow $466, the payment rate for APC 5054 CY 2014 through CY 2017 final rules for assignment of moderately priced (Level 4 Skin Procedures) was $1,468, with comment period, we analyzed skin substitutes to a newly created and the payment rate for APC 5055 updated CY 2016 claims data to middle group. (Level 5 Skin Procedures) was $2,575. calculate the MUC threshold (a We share the goal of promoting This information also is available in weighted average of all skin substitutes’ payment stability for skin substitute Addenda A and B of the CY 2017 OPPS/ MUCs) and the PDC threshold (a products and their related procedures as ASC final rule with comment period weighted average of all skin substitutes’ price stability allows hospitals using (which is available via the Internet on PDCs). The final CY 2018 MUC such products to more easily anticipate the CMS Web site). threshold is $46 per cm2 (rounded to the future payments associated with these We have continued the high cost/low nearest $1) (proposed at $47 per cm2) products. We have attempted to limit cost categories policy since CY 2014, and the final CY 2018 PDC threshold is year to year shifts for skin substitute and in the CY 2018 OPPS/ASC $861 (rounded to the nearest $1) products between the high cost and low proposed rule (82 FR 33626 through (proposed at $755). cost groups through multiple initiatives 33627), we proposed to continue it for For CY 2018, we proposed to continue implemented since CY 2014, including: CY 2018 with the modification to assign skin substitutes with pass- establishing separate skin substitute discussed below. Under this current through payment status to the high cost application procedure codes for low- policy, skin substitutes in the high cost category. However, there are no skin cost skin substitutes (78 FR 74935); category are reported with the skin substitutes that are proposed to have using a skin substitute’s MUC calculated substitute application CPT codes, and pass-through payment status for CY from outpatient hospital claims data skin substitutes in the low cost category 2018. We proposed to assign skin instead of an average of ASP+6 percent are reported with the analogous skin substitutes with pricing information but as the primary methodology to assign substitute HCPCS C-codes. For a without claims data to calculate a products to the high cost or low cost discussion of the CY 2014 and CY 2015 geometric MUC or PDC to either the group (79 FR 66883); and establishing methodologies for assigning skin high cost or low cost category based on the PDC threshold as an alternate substitutes to either the high cost group the product’s ASP+6 percent payment methodology to assign a skin substitute or the low cost group, we refer readers rate as compared to the MUC threshold. to the high cost group (80 FR 70434 to the CY 2014 OPPS/ASC final rule If ASP is not available, we stated in the through 70435). with comment period (78 FR 74932 proposed rule that we would use In order to allow additional time to through 74935) and the CY 2015 OPPS/ WAC+6 percent or 95 percent of AWP evaluate concerns and suggestions from ASC final rule with comment period (79 to assign a product to either the high stakeholders about the volatility of the FR 66882 through 66885). cost or low cost category. We also stated MUC and PDC thresholds, for CY 2018, For a discussion of the high cost/low in the proposed rule that new skin we proposed that a skin substitute that cost methodology that was adopted in substitutes without pricing information was assigned to the high cost group for CY 2016 and has been in effect since would be assigned to the low cost CY 2017 would be assigned to the high then, we refer readers to the CY 2016 category until pricing information is cost group for CY 2018, even if it does OPPS/ASC final rule with comment available to compare to the CY 2018 not exceed the CY 2018 MUC or PDC period (80 FR 70434 through 70435). MUC threshold. For a discussion of our thresholds. Our analysis has found that For CY 2018, as in CY 2016 and CY existing policy under which we assign seven skin substitute products that 2017, we proposed to continue to skin substitutes without pricing would have otherwise been assigned to determine the high/low cost status for information to the low cost category the low cost group for CY 2018 would each skin substitute product based on until pricing information is available, instead be assigned to the high cost either a product’s geometric mean unit we refer readers to the CY 2016 OPPS/ group under this proposed policy. The cost (MUC) exceeding the geometric ASC final rule with comment period (80 skin substitute products affected by this MUC threshold or the product’s per day FR 70436). proposed policy were identified with an cost (PDC) (the total units of a skin Some skin substitute manufacturers ‘‘*’’ in Table 24 of the proposed rule (82 substitute multiplied by the mean unit have raised concerns about significant FR 33627 through 33628). For CY 2019 cost and divided by the total number of fluctuation in both the MUC threshold and subsequent years, we requested days) exceeding the PDC threshold. For and the PDC threshold from year to public comments on how we should CY 2018, as for CY 2017, we proposed year. The fluctuation in the thresholds calculate data for products in to assign each skin substitute that may result in the reassignment of determining the MUC and PDC
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thresholds that are included in the high products in the OPPS. The commenters Comment: One commenter opposed cost group solely based on assignment covered such issues as: Improving the CMS’ proposal to assign all skin to the high cost group in CY 2017. quality of claims data CMS uses to substitutes that qualified for the high We stated in the proposed rule that determine the MUC and PDC cost group in CY 2017 to the high cost the goal of our proposal to retain the thresholds; using ASP pricing data for group in CY 2018, including those skin same skin substitute cost group the skin substitutes either in addition to substitutes that would have not met assignments in CY 2018 as in CY 2017 or in place of claims data to determine either the MUC or PDC threshold in CY is to maintain similar levels of payment the MUC and PDC thresholds; limiting 2018 and would have instead been for skin substitute products for CY 2018 annual changes to the MUC and PDC assigned to the low-cost group. The while we study our current skin thresholds to the change in the commenter stated that the products substitute payment methodology to consumer price index; adding more cost included in the high cost group that determine whether refinement to the groups where skin substitutes may be otherwise would have been assigned to existing policies is consistent with our assigned; ending the packaging of skin the low cost group have generated policy goal of providing payment substitute products in general and enough payment data for CMS to stability for skin substitutes. We ending packaging costs for add-on codes estimate their costs. The commenter requested public comments on the into the primary service codes for skin believed the proposal would encourage methodologies that are used to calculate substitute procedures; establishing excessive use of the skin substitute pricing thresholds as well as the device offsets when the cost of a skin products that should have been assigned payment groupings that recognize a low substitute used in a procedure is more to the low cost group. cost group and a high cost group. We than 40 percent of total cost of the Response: We appreciate the concerns stated that we are especially interested procedure; and reducing incentives that of the commenter. However, as we in suggestions that are based on analysis favor the use of more expensive skin stated in the proposed rule, we aim to of Medicare claims data from hospital substitutes or products that require an encourage the goal of payment stability outpatient departments that might better excessive number of applications. for all skin substitute products to help promote improved payment stability for Response: We appreciate the feedback hospitals anticipate future costs related skin substitute products under the we received from the commenters. We to skin substitute procedures. The MUC OPPS. This proposal was intended to will continue to study issues related to has nearly doubled since CY 2016, with 2 apply for CY 2018 to allow time for the the payment of skin substitutes and take an increase from $25 per cm to the public to submit other ideas that could these comments into consideration for proposed CY 2018 threshold of $47 per 2 be evaluated for the CY 2019 future rulemaking. cm . Likewise, the PDC has fluctuated rulemaking. over $300, between $715 and $1,050, Comment: One commenter requested In summary, we proposed to assign since it was established in CY 2016. We that PuraPly and PuraPly antimic skin substitutes with a MUC or a PDC requested suggestions from the public to reported with HCPCS code Q4172 retain that does not exceed either the MUC help address these stability issues in its pass-through status in CY 2018. The threshold or the PDC threshold to the future rulemaking. We believe allowing commenter believed that giving PuraPly low cost group, unless the product was all skin substitute products assigned to and PuraPly antimic an additional year assigned to the high cost group in CY the high cost group in CY 2017 to of pass-through payment status would 2017, in which case we proposed to remain in the high cost group for CY be consistent with CMS’ policy proposal assign the product to the high cost 2018 gives us time to consider revisions to assign all skin substitute products group for CY 2018, regardless of to the payment of skin substitute that were in the high cost skin substitute whether it exceeds the CY 2018 MUC or procedures and products while avoiding group in CY 2017 to the high cost skin PDC threshold. We also proposed to substantial payment reductions to substitute group in CY 2018. The assign to the high cost group skin hospitals during our review period. commenter believed that, consistent substitute products that exceed the CY Comment: Several commenters with the spirit of this proposal, PuraPly 2018 MUC or PDC threshold and assign supported the proposal to assign all skin and PuraPly antimic should receive the to the low cost group skin substitute substitutes that qualified for the high same payment treatment in CY 2017 as products that did not exceed either the cost group in CY 2017 to the high cost it did in CY 2018; that is, continued CY 2017 or CY 2018 MUC or PDC group in CY 2018, including those skin pass-through payment status. thresholds and were not assigned to the substitutes that would have not met high cost group in CY 2017. We Response: PuraPly and PuraPly either the MUC or PDC threshold in CY proposed to continue to use payment antimic (HCPCS code Q4172) became 2018 and would have instead been methodologies including ASP+6 eligible for drug and biological pass- assigned to the low cost group. percent, WAC+6 percent, or 95 percent through payments effective January 1, Response: We appreciate the of AWP for skin substitute products that 2015. Therefore, 2017 is the third year commenters’ support. have pricing information but do not of pass-through payment status for these Comment: One commenter supported have claims data to determine if their skin substitutes. Section the proposed assignment of HCPCS code costs exceed the CY 2018 MUC 1833(t)(6)(B)(iii) provides for temporary Q4150 (Allowrap DS or Dry 1 sq cm) to threshold. Finally, we proposed to pass-through payments for devices for a the high cost group. continue to assign new skin substitute period of at least 2 years but not more Response: We appreciate the products without pricing information to than 3 years. Extending PuraPly and commenter’s support. the low cost group. PuraPly antimic for a fourth year of After consideration of the public Comment: Several commenters pass-through payment status would be comments we received, we are responded to CMS’ request for public contrary to the statute. Therefore, finalizing our proposals without comments on the methodologies that are PuraPly and PuraPly antimic will be modification for CY 2018. Table 72 used to calculate pricing thresholds as assigned to the high-cost skin substitute below displays the CY 2018 cost well as the payment groupings that group for CY 2018 and the product will category assignment for each skin recognize a low cost group and a high receive payment in the same manner as substitute product. cost group with the goal of improving other skin substitute products assigned For this final rule with comment payment stability for skin substitute to the high cost group. period, we have identified 10 skin
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substitute products that would our policy to include in the high cost affected by this policy are identified otherwise have been assigned to the low group for CY 2018 any skin substitute with an asterisk ‘‘*’’ in Table 72 below. cost group for CY 2018, but will instead that was in the high cost group for CY be assigned to the high cost group under 2017. The skin substitute products
TABLE 72—SKIN SUBSTITUTE ASSIGNMENTS TO HIGH COST AND LOW COST GROUPS FOR CY 2018
CY 2017 CY 2018 CY 2018 CY 2018 short descriptor high/low high/low HCPCS code assignment assignment
C9363 ...... Integra Meshed Bil Wound Mat ...... High ...... High. Q4100 ...... Skin Substitute, NOS ...... Low ...... Low. Q4101 ...... Apligraf ...... High ...... High. Q4102 ...... Oasis Wound Matrix ...... Low ...... Low. Q4103 ...... Oasis Burn Matrix ...... High ...... High.* Q4104 ...... Integra BMWD ...... High ...... High. Q4105 ...... Integra DRT ...... High ...... High.* Q4106 ...... Dermagraft ...... High ...... High. Q4107 ...... GraftJacket ...... High ...... High. Q4108 ...... Integra Matrix ...... High ...... High.* Q4110 ...... Primatrix ...... High ...... High.* Q4111 ...... Gammagraft ...... Low ...... Low. Q4115 ...... Alloskin ...... Low ...... Low. Q4116 ...... Alloderm ...... High ...... High. Q4117 ...... Hyalomatrix ...... Low ...... Low. Q4121 ...... Theraskin ...... High ...... High. Q4122 ...... Dermacell ...... High ...... High. Q4123 ...... Alloskin ...... High ...... High.* Q4124 ...... Oasis Tri-layer Wound Matrix ...... Low ...... Low. Q4126 ...... Memoderm/derma/tranz/integup ...... High ...... High. Q4127 ...... Talymed ...... High ...... High.* Q4128 ...... Flexhd/Allopatchhd/Matrixhd ...... High ...... High. Q4131 ...... Epifix ...... High...... High Q4132 ...... Grafix core and grafixpl core, per square centimeter ...... High ...... High. Q4133 ...... Grafix prime and grafixpl prime, per square centimeter ...... High ...... High. Q4134 ...... hMatrix ...... Low ...... Low. Q4135 ...... Mediskin ...... Low ...... Low. Q4136 ...... Ezderm ...... Low ...... Low. Q4137 ...... Amnioexcel or Biodexcel, 1cm ...... High ...... High. Q4138 ...... Biodfence DryFlex, 1cm ...... High ...... High. Q4140 ...... Biodfence 1cm ...... High ...... High. Q4141 ...... Alloskin ac, 1cm ...... High ...... High.* Q4143 ...... Repriza, 1cm ...... High ...... High. Q4146 ...... Tensix, 1CM ...... High ...... High. Q4147 ...... Architect ecm, 1cm ...... High ...... High.* Q4148 ...... Neox cord 1k, neox cord rt, or clarix cord 1k, per square centimeter ...... High ...... High. Q4150 ...... Allowrap DS or Dry 1 sq cm ...... High ...... High. Q4151 ...... AmnioBand, Guardian 1 sq cm ...... High ...... High. Q4152 ...... Dermapure 1 square cm ...... High ...... High. Q4153 ...... Dermavest 1 square cm ...... High ...... High. Q4154 ...... Biovance 1 square cm ...... High ...... High. Q4156 ...... Neox 100 or clarix 100, per square centimeter ...... High ...... High. Q4157 ...... Revitalon 1 square cm ...... High ...... High. Q4158 ...... Kerecis omega3, per square centimeter ...... High ...... High.* Q4159 ...... Affinity 1 square cm ...... High ...... High. Q4160 ...... NuShield 1 square cm ...... High ...... High. Q4161 ...... Bio-Connekt per square cm ...... High ...... High.* Q4163 ...... Woundex, bioskin, per square centimeter ...... High ...... High. Q4164 ...... Helicoll, per square cm ...... High ...... High. Q4165 ...... Keramatrix, per square cm ...... Low ...... Low. Q4166 ...... Cytal, per square cm ...... Low ...... Low. Q4167 ...... Truskin, per square cm ...... Low ...... Low. Q4169 ...... Artacent wound, per square cm ...... High ...... High. Q4170 ...... Cygnus, per square cm ...... Low ...... Low. Q4172 ...... PuraPly, PuraPly antimic ...... High ...... High. Q4173 ...... Palingen or palingen xplus, per sq cm ...... High ...... High. Q4175 ...... Miroderm, per square cm ...... High ...... High. Q4176 ...... Neopatch, per square centimeter ...... Low ...... Low. Q4178 ...... Floweramniopatch, per square centimeter ...... Low ...... Low. Q4179 ...... Flowerderm, per square centimeter ...... Low ...... Low. Q4180 ...... Revita, per square centimeter ...... Low ...... Low. Q4181 ...... Amnio wound, per square centimeter ...... Low ...... Low. Q4182 ...... Transcyte, per square centimeter ...... Low ...... Low. * These products do not exceed either the MUC or PDC threshold for CY 2018, but are assigned to the high cost group because they were as- signed to the high cost group in CY 2017.
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e. Packaging Determination for HCPCS For CY 2018, in order to propose a drug or biological from our claims data Codes That Describe the Same Drug or packaging determination that is to determine the estimated per day cost Biological but Different Dosages consistent across all HCPCS codes that of each drug or biological at less than or In the CY 2010 OPPS/ASC final rule describe different dosages of the same equal to the proposed CY 2018 drug with comment period (74 FR 60490 drug or biological, we aggregated both packaging threshold of $120 (so that all through 60491), we finalized a policy to our CY 2016 claims data and our pricing HCPCS codes for the same drug or make a single packaging determination information at ASP+6 percent across all biological would be packaged) or greater for a drug, rather than an individual of the HCPCS codes that describe each than the proposed CY 2018 drug HCPCS code, when a drug has multiple distinct drug or biological in order to packaging threshold of $120 (so that all HCPCS codes describing different determine the mean units per day of the HCPCS codes for the same drug or dosages because we believed that drug or biological in terms of the HCPCS biological would be separately payable). adopting the standard HCPCS code- code with the lowest dosage descriptor. The proposed packaging status of each The following drugs did not have specific packaging determinations for drug and biological HCPCS code to pricing information available for the these codes could lead to inappropriate which this methodology would apply in payment incentives for hospitals to ASP methodology for the CY 2018 OPPS/ASC proposed rule, and as is our CY 2018 was displayed in Table 25 of report certain HCPCS codes instead of the CY 2018 OPPS/ASC proposed rule others. We continue to believe that current policy for determining the (82 FR 33629). making packaging determinations on a packaging status of other drugs, we used drug-specific basis eliminates payment the mean unit cost available from the We did not receive any public incentives for hospitals to report certain CY 2016 claims data to make the comments on this proposal. Therefore, HCPCS codes for drugs and allows proposed packaging determinations for for CY 2018, we are finalizing our CY hospitals flexibility in choosing to these drugs: HCPCS code J7100 2018 proposal, without modification, to report all HCPCS codes for different (infusion, dextran 40,500 ml) and continue our policy to make packaging dosages of the same drug or only the HCPCS code J7110 (infusion, dextran determinations on a drug-specific basis, lowest dosage HCPCS code. Therefore, 75,500 ml). rather than a HCPCS code-specific basis, in the CY 2018 OPPS/ASC proposed For all other drugs and biologicals for those HCPCS codes that describe the rule (82 FR 33628), we proposed to that have HCPCS codes describing same drug or biological but different continue our policy to make packaging different doses, we then multiplied the dosages. Table 73 below displays the determinations on a drug-specific basis, proposed weighted average ASP+6 final packaging status of each drug and rather than a HCPCS code-specific basis, percent per unit payment amount across biological HCPCS code to which the for those HCPCS codes that describe the all dosage levels of a specific drug or finalized methodology applies for CY same drug or biological but different biological by the estimated units per day 2018. dosages in CY 2018. for all HCPCS codes that describe each
TABLE 73—HCPCS CODES TO WHICH THE CY 2018 DRUG-SPECIFIC PACKAGING DETERMINATION METHODOLOGY APPLIES
CY 2018 HCPCS code CY 2018 long descriptor CY 2018 SI
C9257 ...... Injection, bevacizumab, 0.25 mg ...... K J9035 ...... Injection, bevacizumab, 10 mg ...... K J1020 ...... Injection, methylprednisolone acetate, 20 mg ...... N J1030 ...... Injection, methylprednisolone acetate, 40 mg ...... N J1040 ...... Injection, methylprednisolone acetate, 80 mg ...... N J1460 ...... Injection, gamma globulin, intramuscular, 1 cc ...... K J1560 ...... Injection, gamma globulin, intramuscular over 10 cc ...... K J1642 ...... Injection, heparin sodium, (heparin lock flush), per 10 units ...... N J1644 ...... Injection, heparin sodium, per 1000 units ...... N J1840 ...... Injection, kanamycin sulfate, up to 500 mg ...... N J1850 ...... Injection, kanamycin sulfate, up to 75 mg ...... N J2788 ...... Injection, rho d immune globulin, human, minidose, 50 micrograms (250 i.u.) ...... N J2790 ...... Injection, rho d immune globulin, human, full dose, 300 micrograms (1500 i.u.) ...... N J2920 ...... Injection, methylprednisolone sodium succinate, up to 40 mg ...... N J2930 ...... Injection, methylprednisolone sodium succinate, up to 125 mg ...... N J3471 ...... Injection, hyaluronidase, ovine, preservative free, per 1 usp unit (up to 999 usp units) ...... N J3472 ...... Injection, hyaluronidase, ovine, preservative free, per 1000 usp units ...... N J7030 ...... Infusion, normal saline solution, 1000 cc ...... N J7040 ...... Infusion, normal saline solution, sterile (500 ml = 1 unit) ...... N J7050 ...... Infusion, normal saline solution, 250 cc ...... N J7100 ...... Infusion, dextran 40, 500 ml ...... N J7110 ...... Infusion, dextran 75, 500 ml ...... N J7515 ...... Cyclosporine, oral, 25 mg ...... N J7502 ...... Cyclosporine, oral, 100 mg ...... N J8520 ...... Capecitabine, oral, 150 mg ...... N J8521 ...... Capecitabine, oral, 500 mg ...... N J9250 ...... Methotrexate sodium, 5 mg ...... N J9260 ...... Methotrexate sodium, 50 mg ...... N
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2. Payment for Drugs and Biologicals such as pharmacy services and handling proposed to continue our payment Without Pass-Through Status That Are costs. Section 1833(t)(14)(E)(i) of the Act policy that has been in effect from CY Not Packaged required MedPAC to study pharmacy 2013 to present and pay for separately a. Payment for Specified Covered overhead and related expenses and to payable drugs and biologicals at ASP+6 Outpatient Drugs (SCODs) and Other make recommendations to the Secretary percent in accordance with section Separately Payable and Packaged Drugs regarding whether, and if so how, a 1833(t)(14)(A)(iii)(II) of the Act (the and Biologicals payment adjustment should be made to statutory default). We proposed that the compensate hospitals for overhead and ASP+6 percent payment amount for Section 1833(t)(14) of the Act defines related expenses. Section separately payable drugs and biologicals certain separately payable 1833(t)(14)(E)(ii) of the Act authorizes requires no further adjustment and radiopharmaceuticals, drugs, and the Secretary to adjust the weights for represents the combined acquisition and biologicals and mandates specific ambulatory procedure classifications for pharmacy overhead payment for drugs payments for these items. Under section SCODs to take into account the findings and biologicals. We also proposed that 1833(t)(14)(B)(i) of the Act, a ‘‘specified of the MedPAC study.17 payments for separately payable drugs covered outpatient drug’’ (known as a It has been our policy since CY 2006 and biologicals are included in the SCOD) is defined as a covered to apply the same treatment to all budget neutrality adjustments, under outpatient drug, as defined in section separately payable drugs and the requirements in section 1833(t)(9)(B) 1927(k)(2) of the Act, for which a biologicals, which include SCODs, and of the Act, and that the budget neutral separate APC has been established and drugs and biologicals that are not weight scalar is not applied in that either is a radiopharmaceutical SCODs. Therefore, we apply the determining payments for these agent or is a drug or biological for which payment methodology in section separately paid drugs and biologicals. payment was made on a pass-through 1833(t)(14)(A)(iii) of the Act to SCODs, We note that we proposed, as basis on or before December 31, 2002. as required by statute, but we also apply specified below, to pay for separately Under section 1833(t)(14)(B)(ii) of the it to separately payable drugs and payable, nonpass-through drugs Act, certain drugs and biologicals are biologicals that are not SCODs, which is acquired with a 340B discount at a rate designated as exceptions and are not a policy determination rather than a of ASP minus 22.5 percent. We refer included in the definition of SCODs. statutory requirement. In the CY 2018 readers to the full discussion of this These exceptions are— OPPS/ASC proposed rule (82 FR 33630), proposal in section V.B.7. of the • A drug or biological for which we proposed to apply section proposed rule and this final rule with payment is first made on or after 1833(t)(14)(A)(iii)(II) of the Act to all comment period. January 1, 2003, under the transitional separately payable drugs and Comment: Numerous commenters pass-through payment provision in biologicals, including SCODs. Although supported CMS’ proposal to continue to section 1833(t)(6) of the Act. we do not distinguish SCODs in this pay for separately payable drugs and • A drug or biological for which a discussion, we note that we are required biologicals based on the statutory temporary HCPCS code has not been to apply section 1833(t)(14)(A)(iii)(II) of default rate of ASP+6 percent. assigned. the Act to SCODs, but we also are Response: We thank commenters for • During CYs 2004 and 2005, an applying this provision to other their support. orphan drug (as designated by the separately payable drugs and After consideration of the public Secretary). biologicals, consistent with our history comments we received, we are Section 1833(t)(14)(A)(iii) of the Act of using the same payment methodology finalizing our proposal, without requires that payment for SCODs in CY for all separately payable drugs and modification, to pay for separately 2006 and subsequent years be equal to biologicals. payable drugs and biologicals at ASP+6 the average acquisition cost for the drug For a detailed discussion of our OPPS percent based on section for that year as determined by the drug payment policies from CY 2006 to 1833(t)(14)(A)(iii)(II) of the Act (the Secretary, subject to any adjustment for CY 2012, we refer readers to the CY statutory default). The ASP+6 percent overhead costs and taking into account 2013 OPPS/ASC final rule with payment amount for separately payable the hospital acquisition cost survey data comment period (77 FR 68383 through drugs and biologicals requires no further collected by the Government 68385). In the CY 2013 OPPS/ASC final adjustment and represents the combined Accountability Office (GAO) in CYs rule with comment period (77 FR 68386 acquisition and pharmacy overhead 2004 and 2005, and later periodic through 68389), we first adopted the payment for drugs and biologicals for surveys conducted by the Secretary as statutory default policy to pay for CY 2018. In addition, we are finalizing set forth in the statute. If hospital separately payable drugs and biologicals our proposal that payment for separately acquisition cost data are not available, at ASP+6 percent based on section payable drugs and biologicals be the law requires that payment be equal 1833(t)(14)(A)(iii)(II) of the Act. We included in the budget neutrality to payment rates established under the continued this policy of paying for adjustments, under the requirements of methodology described in section separately payable drugs and biologicals section 1833(t)(9)(B) of the Act, and that 1842(o), section 1847A, or section at the statutory default for CY 2014, CY the budget neutral weight scalar is not 1847B of the Act, as calculated and 2015, CY 2016, and CY 2017 (81 FR applied in determining payment of adjusted by the Secretary as necessary. 79673). these separately paid drugs and We refer to this alternative methodology biologicals. We refer readers to section as the ‘‘statutory default.’’ Most b. CY 2018 Payment Policy V.B.7. of the final rule with comment physician Part B drugs are paid at In the CY 2018 OPPS/ASC proposed period for the final payment policy for ASP+6 percent in accordance with rule (82 FR 33630), for CY 2018, we drugs acquired with a 340B discount. section 1842(o) and section 1847A of We note that separately payable drug the Act. 17 Medicare Payment Advisory Committee. June and biological payment rates listed in Section 1833(t)(14)(E)(ii) of the Act 2005 Report to the Congress. Chapter 6: Payment for Addenda A and B to this final rule with pharmacy handling costs in hospital outpatient provides for an adjustment in OPPS departments. Available at: http://www.medpac.gov/ comment period (available via the payment rates for SCODs to take into docs/default-source/reports/June05_ Internet on the CMS Web site), which account overhead and related expenses, ch6.pdf?sfvrsn=0. illustrate the final CY 2018 payment of
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ASP+6 percent for separately payable CY 2018 OPPS/ASC proposed rule (82 the following technical correction: All nonpass-through drugs and biologicals FR 33630), for CY 2018, we proposed to biosimilar biological products will be and ASP+6 percent for pass-through continue this same payment policy for eligible for pass-through payment and drugs and biologicals, reflect either ASP biosimilar biological products. not just the first biosimilar biological information that is the basis for We noted in the proposed rule that product for a reference product. calculating payment rates for drugs and public comments on the Medicare Part 3. Payment Policy for Therapeutic biologicals in the physician’s office B biosimilar biological product payment Radiopharmaceuticals setting effective October 1, 2017, or policy should be submitted in response WAC, AWP, or mean unit cost from CY to the biosimilar biological product In the CY 2018 OPPS/ASC proposed 2016 claims data and updated cost payment policy comment solicitation in rule (82 FR 33630), for CY 2018, we report information available for this the CY 2018 MPFS proposed rule. proposed to continue the payment final rule with comment period. In Comment: Several comments urged policy for therapeutic general, these published payment rates CMS to assign separate HCPCS codes for radiopharmaceuticals that began in CY are not the same as the actual January each biosimilar biological product 2010. We pay for separately paid 2018 payment rates. This is because rather than combining biosimilar therapeutic radiopharmaceuticals under payment rates for drugs and biologicals biological products of the same the ASP methodology adopted for with ASP information for January 2018 reference product into one HCPCS code. separately payable drugs and will be determined through the standard Some commenters who addressed the biologicals. If ASP information is quarterly process where ASP data biosimilar payment policy as it relates unavailable for a therapeutic submitted by manufacturers for the to the 340B proposal stated that current radiopharmaceutical, we base third quarter of 2017 (July 1, 2017 policy (adopted in the CY 2016 OPPS/ therapeutic radiopharmaceutical through September 30, 2017) will be ASC final rule with comment period (80 payment on mean unit cost data derived used to set the payment rates that are FR 70445)) for pass-through payment for from hospital claims. We believe that released for the quarter beginning in biosimilar biological products is the rationale outlined in the CY 2010 January 2018 near the end of December restricted to the first biosimilar OPPS/ASC final rule with comment 2017. In addition, payment rates for biological product of a reference period (74 FR 60524 through 60525) for drugs and biologicals in Addenda A and product. The commenters believed that, applying the principles of separately B to this final rule with comment period if the 340B proposal is finalized as payable drug pricing to therapeutic for which there was no ASP information proposed, the preclusion on pass- radiopharmaceuticals continues to be available for October 2017 are based on through payment eligibility for second appropriate for nonpass-through, mean unit cost in the available CY 2016 and subsequent biosimilar biological separately payable therapeutic claims data. If ASP information becomes products of the same reference product radiopharmaceuticals in CY 2018. available for payment for the quarter would be significantly disadvantaged by Therefore, we proposed for CY 2018 to beginning in January 2018, we will price the reduced payment if purchased with pay all nonpass-through, separately payment for these drugs and biologicals a 340B discount. These commenters payable therapeutic based on their newly available ASP urged CMS to reevaluate pass-through radiopharmaceuticals at ASP+6 percent, information. Finally, there may be drugs payment eligibility for biosimilar based on the statutory default described and biologicals that have ASP biological products and their payment in section 1833(t)(14)(A)(iii)(II) of the information available for this final rule under the 340B payment proposal in the Act. For a full discussion of ASP-based with comment period (reflecting proposed rule. payment for therapeutic October 2017 ASP data) that do not have Response: Comments related to policy radiopharmaceuticals, we refer readers ASP information available for the for coding for biosimilar biological to the CY 2010 OPPS/ASC final rule quarter beginning in January 2018. As products are outside of the scope of the with comment period (74 FR 60520 stated in the CY 2018 OPPS/ASC CY 2018 OPPS/ASC proposed rule. As through 60521). We also proposed to proposed rule (82 FR 33630), these we indicated in the CY 2018 OPPS/ASC rely on CY 2016 mean unit cost data drugs and biologicals will then be paid proposed rule, commenters should refer derived from hospital claims data for based on mean unit cost data derived to the CY 2018 MPFS final rule for payment rates for therapeutic from CY 2016 hospital claims. discussion of the biosimilar biological radiopharmaceuticals for which ASP Therefore, the payment rates listed in product coding policy. With respect to data are unavailable and to update the Addenda A and B to this final rule with comments regarding OPPS payment for payment rates for separately payable comment period are not for January biosimilar biological products, in the CY therapeutic radiopharmaceuticals 2018 payment purposes and are only 2018 MPFS final rule, CMS finalized a according to our usual process for illustrative of the CY 2018 OPPS policy to implement separate HCPCS updating the payment rates for payment methodology using the most codes for biosimilar biological products. separately payable drugs and biologicals recently available information at the Therefore, consistent with our on a quarterly basis if updated ASP time of issuance of this final rule with established OPPS drug, biological, and information is unavailable. For a comment period. radiopharmaceutical payment policy, complete history of the OPPS payment HCPCS coding for biosimilar biological policy for therapeutic c. Biosimilar Biological Products products will be based on policy radiopharmaceuticals, we refer readers For CY 2016 and CY 2017, we established under the CY 2018 MPFS to the CY 2005 OPPS final rule with finalized a policy to pay for biosimilar rule. comment period (69 FR 65811), the CY biological products based on the Comments related to 340B and 2006 OPPS final rule with comment payment allowance of the product as biosimilar biological products are period (70 FR 68655), and the CY 2010 determined under section 1847A of the discussed in section V.B.7. of this final OPPS/ASC final rule with comment Act and to subject nonpass-through rule with comment period. period (74 FR 60524). The proposed CY biosimilar biological products to our After consideration of the public 2018 payment rates for nonpass- annual threshold-packaged policy (for comments we received, we are through, separately payable therapeutic CY 2016, 80 FR 70445 through 70446; finalizing our proposed payment policy radiopharmaceuticals were in Addenda and for CY 2017, 81 FR 79674). In the for biosimilar biological products, with A and B to the proposed rule (which are
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available via the Internet on the CMS the Technetium-99 (Tc-99m), the beneficiary copayment could discourage Web site). radioisotope used in the majority of hospital adoption. Comment: Commenters supported such diagnostic imaging services, is Response: We appreciate the continuation of the policy to pay ASP+6 produced in legacy reactors outside of commenters’ support. As discussed in percent for therapeutic the United States using highly enriched the CY 2013 OPPS/ASC final rule with radiopharmaceuticals, if available, and uranium (HEU). comment period, we did not finalize a to base payment on the mean unit cost The United States would like to policy to use the usual OPPS derived from hospital claims data when eliminate domestic reliance on these methodologies to update the non-HEU not available. Commenters also reactors, and is promoting the add-on payment (77 FR 68317). The requested that CMS examine ways to conversion of all medical radioisotope purpose for the additional payment is compensate hospitals for their production to non-HEU sources. limited to mitigating any adverse impact documented higher overhead and Alternative methods for producing Tc- of transitioning to non-HEU sources and handling costs associated with 99m without HEU are technologically is based on the authority set forth at radiopharmaceuticals. and economically viable, and section 1833(t)(2)(E) of the Act. Response: We appreciate the conversion to such production has Accordingly, because we do not have commenters’ support. However, as we begun. We expect that this change in the authority to waive beneficiary stated earlier in section V.B.1.c. of this supply source for the radioisotope used copayment for this incentive payment, final rule with comment period in for modern medical imaging will we believe it is unnecessary to assess response to a similar request for introduce new costs into the payment whether a beneficiary copayment additional radiopharmaceutical system that are not accounted for in the liability would deter a hospital from payment, we continue to believe that a historical claims data. reporting HCPCS code Q9969. single payment is appropriate for Therefore, beginning in CY 2013, we Furthermore, reporting of HCPCS code radiopharmaceuticals with pass-through finalized a policy to provide an Q9969 is optional. Hospitals that are not payment status in CY 2018 and that the additional payment of $10 for the experiencing high volumes of payment rate of ASP+6 percent is marginal cost for radioisotopes significantly increased costs are not appropriate to provide payment for both produced by non-HEU sources (77 FR obligated to request this additional the radiopharmaceutical’s acquisition 68323). Under this policy, hospitals payment (77 FR 68323). cost and any associated nuclear report HCPCS code Q9969 (Tc-99m from Comment: One commenter requested medicine handling and compounding non-highly enriched uranium source, that CMS publish HCPCS code volume costs incurred by the hospital full cost recovery add-on per study and cost data in the proposed and final pharmacy. Payment for the dose) once per dose along with any rule ‘‘Drug Blood Brachy Cost Statistics’’ radiopharmaceutical and diagnostic scan or scans furnished using files yearly. radiopharmaceutical processing services Tc-99m as long as the Tc-99m doses Response: We appreciate the request is made through the single ASP-based used can be certified by the hospital to and will consider revising the content of payment. We refer readers to the CMS be at least 95 percent derived from non- the ‘‘Drug Blood Brachy Cost statistics’’ guidance document available via the HEU sources (77 FR 68321). file to include data on HCPCS code Internet at https://www.cms.gov/ We stated in the CY 2013 OPPS/ASC Q9969 for future rulemaking. In the Medicare/Medicare-Fee-for-Service- final rule with comment period (77 FR interim, claims data on HCPCS code Payment/HospitalOutpatientPPS/ 68321) that our expectation is that this Q9969 are available for purchase in the Archives.html for details on submission additional payment will be needed for claims data sets released with of ASP data for therapeutic the duration of the industry’s publication of this final rule with radiopharmaceuticals. conversion to alternative methods to comment period. After consideration of the public producing Tc-99m without HEU. We After consideration of the public comments we received, we are also stated that we would reassess, and comments we received, we are finalizing our proposal, without propose if necessary, on an annual basis finalizing our proposal, without modification, to continue to pay all whether such an adjustment continued modification, to continue the policy of nonpass-through, separately payable to be necessary and whether any providing an additional $10 payment for therapeutic radiopharmaceuticals at changes to the adjustment were radioisotopes produced by non-HEU ASP+6 percent. We also are finalizing warranted (77 FR 68316). We have sources for CY 2018, which will be the our proposal to continue to rely on CY reassessed this payment for CY 2018 sixth year in which this policy is in 2016 mean unit cost data derived from and did not identify any new effect in the OPPS. We will continue to hospital claims data for payment rates information that would cause us to reassess this policy annually, consistent for therapeutic radiopharmaceuticals for modify payment. Therefore, in the CY with the original policy in the CY 2013 which ASP data are unavailable. The CY 2018 OPPS/ASC proposed rule (82 FR OPPS/ASC final rule with comment 2018 final rule payment rates for 33631), for CY 2018, we proposed to period (77 FR 68319). nonpass-through separately payable continue to provide an additional $10 5. Payment for Blood Clotting Factors therapeutic radiopharmaceuticals are payment for radioisotopes produced by included in Addenda A and B to this non-HEU sources. For CY 2017, we provided payment final rule with comment period (which Comment: Commenters supported for blood clotting factors under the same are available via the Internet on the CMS’ proposal to provide an additional methodology as other nonpass-through CMS Web site). $10 payment for the marginal cost of separately payable drugs and biologicals radioisotopes produced by non-HEU under the OPPS and continued paying 4. Payment Adjustment Policy for sources and supported continuation of an updated furnishing fee (81 FR Radioisotopes Derived From Non- the policy. However, the commenters 79676). That is, for CY 2017, we Highly Enriched Uranium Sources requested that CMS update the payment provided payment for blood clotting Radioisotopes are widely used in amount using the hospital market basket factors under the OPPS at ASP+6 modern medical imaging, particularly update or hospital cost data. The percent, plus an additional payment for for cardiac imaging and predominantly commenters also requested that CMS the furnishing fee. We note that when for the Medicare population. Some of assess whether the collection of a blood clotting factors are provided in
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physicians’ offices under Medicare Part instructions and posting on the CMS available. The CY 2018 payment status B and in other Medicare settings, a Web site. of each of the nonpass-through drugs, furnishing fee is also applied to the biologicals, and radiopharmaceuticals 6. Payment for Nonpass-Through Drugs, payment. The CY 2017 updated with HCPCS codes but without OPPS Biologicals, and Radiopharmaceuticals hospital claims data is listed in furnishing fee was $0.209 per unit. With HCPCS Codes but Without OPPS Addendum B to this final rule with In the CY 2018 OPPS/ASC proposed Hospital Claims Data rule (82 FR 33631), for CY 2018, we comment period, which is available via proposed to pay for blood clotting In the CY 2018 OPPS/ASC proposed the Internet on the CMS Web site. rule (82 FR 33631), for CY 2018, we factors at ASP+6 percent, consistent 7. Alternative Payment Methodology for with our proposed payment policy for proposed to continue to use the same payment policy as in CY 2017 for Drugs Purchased Under the 340B other nonpass-through, separately Program payable drugs and biologicals, and to nonpass-through drugs, biologicals, and continue our policy for payment of the radiopharmaceuticals with HCPCS a. Background furnishing fee using an updated amount. codes but without OPPS hospital claims The 340B Program, which was Our policy to pay for a furnishing fee for data, which describes how we established by section 340B of the blood clotting factors under the OPPS is determine the payment rate for drugs, Public Health Service Act by the consistent with the methodology biologicals, or radiopharmaceuticals Veterans Health Care Act of 1992, is applied in the physician’s office and in without an ASP. For a detailed administered by the Health Resources the inpatient hospital setting. These discussion of the payment policy and and Services Administration (HRSA) methodologies were first articulated in methodology, we refer readers to the CY within HHS. The 340B Program allows the CY 2006 OPPS final rule with 2016 OPPS/ASC final rule with participating hospitals and other health comment period (70 FR 68661) and later comment period (80 FR 70442 through care providers to purchase certain discussed in the CY 2008 OPPS/ASC 70443). The proposed CY 2018 payment ‘‘covered outpatient drugs’’ (as defined status of each of the nonpass-through final rule with comment period (72 FR under section 1927(k) of the Act and drugs, biologicals, and 66765). The proposed furnishing fee interpreted by HRSA through various radiopharmaceuticals with HCPCS update was based on the percentage guidance documents) at discounted codes but without OPPS hospital claims increase in the Consumer Price Index prices from drug manufacturers. The data was listed in Addendum B to the (CPI) for medical care for the 12-month statutory intent of the 340B Program is proposed rule, which is available via the period ending with June of the previous to maximize scarce Federal resources as Internet on the CMS Web site. much as possible, reaching more eligible year. Because the Bureau of Labor Comment: One commenter, the patients, and providing care that is more Statistics releases the applicable CPI manufacturer of Mylotarg®, requested data after the MPFS and OPPS/ASC comprehensive.18 that CMS change the dose descriptor for The 340B statute defines which health proposed rules are published, we were HCPCS code J9300 from ‘‘Injection, not able to include the actual updated care providers are eligible to participate gemtuzumab ozogamicin, 5 mg’’ to in the program (‘‘covered entities’’). In furnishing fee in the proposed rules. ‘‘Injection, gemtuzumab ozogamicin, 0.1 Therefore, in accordance with our addition to Federal health care grant mg,’’ to accommodate the new 4.5 mg recipients, covered entities include policy, as finalized in the CY 2008 vial size for Mylotarg®. The commenter OPPS/ASC final rule with comment hospitals with a Medicare noted that HCPCS code J9300 was disproportionate share hospital (DSH) period (72 FR 66765), we proposed to inactive for a period of time because the announce the actual figure for the percentage above 11.75 percent. prior version of gemtuzumab However, under Public Law 111–148, percent change in the applicable CPI ozogamicin was removed from the and the updated furnishing fee section 7101 expanded eligibility to market. As such, HCPCS code J9300 is critical access hospitals (CAHs), calculated based on that figure through assigned status indicator ‘‘E2 (items and applicable program instructions and children’s hospitals with a DSH services for which pricing information adjustment greater than 11.75 percent, posting on the CMS Web site at: http:// and claims data are not available).’’ The www.cms.gov/Medicare/Medicare-Fee- sole community hospitals (SCHs) with a commenter also requested that CMS DSH adjustment percentage of 8.0 for-Service-Part-B-Drugs/ change the status indicator from ‘‘E2’’ to McrPartBDrugAvgSalesPrice/ percent or higher, rural referral centers a payable status indicator. (RRCs) with a DSH adjustment index.html. Response: This comment is outside of percentage of 8.0 percent or higher, and Comment: Commenters’ supported the scope of the proposed rule. Requests freestanding cancer hospitals with a CMS’ proposal to continue to pay for a for changes to Level II Alphanumeric DSH adjustment percentage above 11.75 blood clotting factor furnishing fee in HCPCS codes should be submitted to percent. In accordance with section the hospital outpatient department. the CMS HCPCS Workgroup using CMS’ 340B(a)(4)(L)(i) of the Public Health Response: We appreciate the standard procedures. Information on the Service Act, all participating hospital commenters’ support. Level II HCPCS code process is available types must also meet other criteria. After consideration of the public via the Internet on the CMS Web site, HRSA calculates the ceiling price for comments we received, we are which is publicly available at: https:// each covered outpatient drug. The finalizing our proposal, without www.cms.gov/Medicare/Coding/ ceiling price is the drug’s average modification, to provide payment for MedHCPCSGenInfo/ manufacturer price (AMP) minus the blood clotting factors under the same HCPCSCODINGPROCESS.html. unit rebate amount (URA), which is a methodology as other separately payable After consideration of the public drugs and biologicals under the OPPS comments we received, we are 18 The House report that accompanied the and to continue payment of an updated finalizing our CY 2018 proposal without authorizing legislation for the 340B Program stated: furnishing fee. We will announce the modification, including our proposal to ‘‘In giving these ‘covered entities’ access to price actual figure of the percent change in assign drug or biological products status reductions the Committee intends to enable these entities to stretch scarce Federal resources as far as the applicable CPI and the updated indicator ‘‘K’’ and pay for them possible, reaching more eligible patients and furnishing fee calculation based on that separately for the remainder of CY 2018 providing more comprehensive services.’’ (H.R. figure through the applicable program if pricing information becomes Rept. No. 102–384(II), at 12 (1992)).
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statutory formula that varies depending costs that 340B hospitals incur to clinics) average 33.6 percent of ASP, on whether the drug is an innovator acquire drugs covered under the OPPS, allowing these providers to generate single source drug (no generic MedPAC generally used the formula for significant profits when they administer available), an innovator multiple source calculating the 340B ceiling price: Part B drugs. According to the U.S. drug (a brand drug with available (AMP)—unit rebate amount (URA) × Government Accountability Office generic(s)), or a non-innovator multiple drug package size. The URA is (GAO) report, the amount of the 340B source (generic) drug.19 The ceiling determined by law and depends upon discount ranges from an estimated 20 to price represents the maximum price a whether a drug is classified as single 50 percent discount, compared to what participating drug manufacturer can source, innovator multiple source, non- the entity would have otherwise paid to charge a covered entity for the drug. innovator multiple source, a clotting purchase the drug. In addition, However, covered entities also have the factor drug, or an exclusively pediatric participation in the PVP often results in option to participate in HRSA’s Prime drug. CMS provides this URA a covered entity paying a subceiling Vendor Program (PVP), under which the information to States as a courtesy. price on some covered outpatient drugs prime vendor can negotiate even deeper However, drug manufacturers remain (estimated to be approximately 10 discounts (known as ‘‘subceiling responsible for correctly calculating the percent below the ceiling price) (U.S. prices’’) on some covered outpatient URA for their covered outpatient drugs. Department of Health and Human drugs. By the end of FY 2015, the PVP More information on the URA Services, HRSA FY 2018 Budget had nearly 7,600 products available to calculation and the Medicaid Drug Justification). Participation in the PVP is participating entities below the 340B Rebate Program may be found on the voluntary and free. ceiling price, including 3,557 covered Web site at: https://www.medicaid.gov/ As noted in the CY 2018 OPPS/ASC outpatient drugs with an estimated medicaid/prescription-drugs/medicaid- proposed rule, with respect to average savings of 10 percent below the drug-rebate-program/index.html. chemotherapy drugs and drug 340B ceiling price.20 Because MedPAC did not have access administration services, MedPAC As we discussed in the CY 2018 to AMP data, it used each drug’s ASP as examined Medicare Part B spending for OPPS/ASC proposed rule (82 FR 33632 a proxy for AMP. MedPAC noted that 340B and non-340B hospitals for a 5- and 33633), several recent studies and ASP is typically slightly lower than year period from 2008 to 2012 and reports on Medicare Part B payments for AMP. The AMP is defined under section found that ‘‘Medicare spending grew 340B purchased drugs highlight a 1927(k)(1) of the Act as the average faster among hospitals that participated difference in Medicare Part B drug price paid to the manufacturer by in the 340B Program for all five years spending between 340B hospitals and wholesalers in the United States for than among hospitals that did not non-340B hospitals as well as varying drugs distributed to the retail pharmacy participate in the 340B Program at any differences in the amount by which the class of trade, minus customary prompt time during [the study] period’’ Part B payment exceeds the drug pay discounts. Manufacturers (MedPAC May 2015 Report to Congress, acquisition cost.21 22 23 Links to the full participating in Medicaid are required page 14). This is just one example of reports referenced in this section can be to report AMP data quarterly to the drug spending increases that are found in the cited footnotes. Secretary, and these prices are correlated with participation in the In its May 2015 Report to Congress, confidential. As described under section 340B Program and calls into question MedPAC analyzed Medicare hospital 1847A of the Act, the ASP is a whether Medicare’s current policy to outpatient claims (excluding CAHs) manufacturer’s unit sales of a drug to all pay for separately payable drugs at along with information from HRSA on purchasers in the United States in a ASP+6 percent is appropriate in light of which hospitals participate in the 340B calendar quarter divided by the total the discounted rates at which 340B Program. MedPAC included data on all number of units of the drug sold by the hospitals acquire such drugs. separately payable drugs under the manufacturer in that same quarter. The Further, GAO found that ‘‘in both OPPS except for vaccines and orphan ASP is net of any price concessions 2008 and 2012, per beneficiary drugs provided by freestanding cancer such as volume, prompt pay, and cash Medicare Part B drug spending, hospitals, RRCs, and SCHs. To estimate discounts. Certain sales are exempt from including oncology drug spending, was the calculation of ASP, including sales substantially higher at 340B DSH 19 42 U.S.C. 256b(a)(1–2). Occasionally, a drug’s at a nominal charge and 340B discounts. hospitals than at non-340B hospitals.’’ URA is equal to its AMP, resulting in a 340B ceiling In addition, MedPAC noted that, due According to the GAO report, this price of $0. In these instances, HRSA has advised manufacturers to charge covered entities $0.01 per to data limitations, its estimates of indicates that, on average, beneficiaries unit. ceiling prices are conservative and at 340B DSH hospitals were either 20 Department of Health and Human Services. likely higher (possibly much higher) prescribed more drugs or more 2017. Fiscal Year 2018 Health Resources and than actual ceiling prices. Further expensive drugs than beneficiaries at Services Administration justification of estimates for appropriations committees. Washington, DC: details on the methodology used to the other non-340B hospitals in GAO’s HHS. Available at: https://www.hrsa.gov/sites/ calculate the average minimum discount analysis. For example, in 2012, average default/files/hrsa/about/budget/budget- for separately payable drugs can be per beneficiary spending at 340B DSH justification-2018.pdf. found in Appendix A of MedPAC’s May hospitals was $144, compared to 21 Office of Inspector General. ‘‘Part B Payment 2015 Report to Congress. In this report, approximately $60 at non-340B for 340B Purchased Drugs. OEI–12–14–00030’’. November 2015. Available at: https://oig.hhs.gov/ MedPAC estimated that, on average, hospitals. The differences did not oei/reports/oei-12-14-00030.pdf. hospitals in the 340B Program ‘‘receive appear to be explained by the hospital 22 Medicare Payment Advisory Commission. a minimum discount of 22.5 percent of characteristics GAO examined or Report to the Congress: Overview of the 340B Drug the [ASP] for drugs paid under the patients’ health status (GAO Report 15– Pricing Program. May 2015. Available at: http:// www.medpac.gov/docs/default-source/reports/may- [OPPS].’’ 442, page 20). 2015-report-to-the-congress-overview-of-the-340b- In its March 2016 Report to Congress Under the OPPS, all hospitals (other drug-pricing-program.pdf?sfvrsn=0. (page 79), MedPAC noted that another than CAHs, which are paid based on 23 Government Accountability Office. ‘‘Medicare report, which MedPAC attributed to the 101 percent of reasonable costs as Part B Drugs: Action Needed to Reduce Financial Office of the Inspector General (OIG), required by section 1834(g) of the Act) Incentives to Prescribe 340B Drugs at Participating Hospitals GAO–15–442’’. June 2015. Available at: recently estimated that discounts across are currently paid the same rate for https://www.gao.gov/assets/680/670676.pdf. all 340B providers (hospitals and certain separately payable drugs (ASP+6
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percent), regardless of whether the for hospitals that participate in the 340B on Part B drugs have been rising and are hospital purchased the drug at a Program. In its March 2016 Report to projected to continue to rise faster than discount through the 340B Program. Congress, MedPAC recommended a overall health spending, thereby Medicare beneficiaries are liable for a legislative proposal related to payment increasing this sector’s share of health copayment that is equal to 20 percent of for Part B drugs furnished by 340B care spending due to a number of the OPPS payment rate, which is hospitals under which Medicare would underlying factors such as new higher currently ASP+6 percent (regardless of reduce payment rates for 340B price drugs and price increases for the 340B purchase price for the drug). hospitals’ separately payable 340B drugs existing drugs.26 27 While we recognize Based on an analysis of almost 500 by 10 percent of the ASP and direct the the intent of the 340B Program, we drugs billed in the hospital outpatient program savings from reducing Part B believe it is inappropriate for Medicare setting in 2013, the OIG found that, for drug payment rates to the Medicare to subsidize other activities through 35 drugs, the ‘‘difference between the funded uncompensated care pool.25 In Medicare payments for separately Part B [payment] amount and the 340B its November 2015 report, the OIG payable drugs. We believe that any ceiling price was so large that, in at least described three options under which payment changes we adopt should be one quarter of 2013, the beneficiary’s both the Medicare program and limited to separately payable drugs coinsurance alone . . . was greater than Medicare beneficiaries would be able to under the OPPS, with some additional the amount a covered entity spent to share in the program savings realized by exclusions. As a point of further clarity, acquire the drug’’ (OIG November 2015, hospitals and other covered entities that CAHs are not included in this 340B Report OEI–12–14–00030, page 9). participate in the 340B Program (OEI– policy change because they are paid In the CY 2009 OPPS/ASC final rule 12–14–00030, pages 11–12). These under section 1834(g) of the Act. As with comment period (73 FR 68655), we options included: (1) Paying ASP with stated in the CY 2018 OPPS/ASC requested comments regarding the drug no additional add-on percentage; (2) proposed rule, these exclusions are for: costs of hospitals that participate in the paying ASP minus 14.4 percent; and (3) (1) Drugs on pass-through payment 340B Program and whether we should making payment based on the 340B status, which are required to be paid consider an alternative drug payment ceiling price plus 6 percent of ASP for based on the ASP methodology, and (2) methodology for participating 340B each 340B purchased drug (OEI–12–14– vaccines, which are excluded from the hospitals. As noted above, in the time 00030, page 11). Analysis in several of 340B Program. In addition, we solicited since that comment solicitation, access these reports notes limitations in public comments on whether other to the 340B Program was expanded estimating 340B-purchased drugs’ types of drugs, such as blood clotting under section 7101 of Public Law 111– acquisition costs; the inability to factors, should also be excluded from 148, which amended section 340B(a)(4) identify which drugs were purchased the reduced payment. of the Public Health Service Act to through the 340B Program within Data limitations inhibit our ability to expand the types of covered entities Medicare claims data was one of those identify which drugs were acquired eligible to participate in the 340B limitations. under the 340B Program in the Medicare Program. It is estimated that covered OPPS claims data. This lack of b. OPPS Payment Rate for 340B information within the claims data has entities saved $3.8 billion on outpatient Purchased Drugs drugs purchased through the 340B limited researchers’ and our ability to Program in 2013.24 In addition, the In the CY 2018 OPPS/ASC proposed precisely analyze differences in number of hospitals participating in the rule (82 FR 33633 through 33634), we acquisition cost of 340B and non-340B program has grown from 583 in 2005 to proposed changes to our current acquired drugs with Medicare claims 1,365 in 2010 and 2,140 in 2014 Medicare Part B drug payment data. Accordingly, in the CY 2018 (MedPAC May 2015 Report to methodology for 340B hospitals that we OPPS/ASC proposed rule (82 FR 33633), Congress). In its November 2015 report believe would better, and more we stated our intent to establish a entitled ‘‘Part B Payments for 340B- appropriately, reflect the resources and modifier, to be effective January 1, 2018, Purchased Drugs,’’ the OIG found that acquisition costs that these hospitals for hospitals to report with separately Part B payments were 58 percent more incur. Such changes would allow the payable drugs that were not acquired than 340B ceiling prices, which allowed Medicare program and Medicare under the 340B Program. Because a covered entities to retain approximately beneficiaries to pay less for drugs when significant portion of hospitals paid $1.3 billion in 2013 (OEI–12–14–00030, hospitals participating in the 340B under the OPPS participate in the 340B page 8). Given the growth in the number Program furnish drugs to Medicare Program, we stated our belief that it is of providers participating in the 340B beneficiaries that are purchased under appropriate to presume that a separately Program and recent trends in high and the 340B Program. payable drug reported on an OPPS claim Our goal is to make Medicare growing prices of several separately was purchased under the 340B Program, payment for separately payable drugs payable drugs administered under unless the hospital identifies that the more aligned with the resources Medicare Part B to hospital outpatients, drug was not purchased under the 340B expended by hospitals to acquire such we stated in the CY 2018 OPPS/ASC Program. We stated in the proposed rule drugs while recognizing the intent of the proposed rule that we believe it is that we intended to provide further 340B Program to allow covered entities, timely to reexamine the appropriateness details about this modifier in this CY including eligible hospitals, to stretch of continuing to apply the current OPPS scarce resources in ways that enable 26 methodology of ASP+6 percent to Department of Health and Human Services. hospitals to continue providing access Office of the Assistant Secretary for Planning and hospitals that have acquired those drugs to care for Medicare beneficiaries and Evaluation. Issue Brief: Medicare Part B Drugs: under the 340B Program at significantly Pricing and Incentives. 2016. Available at: https:// other patients. Medicare expenditures discounted rates. aspe.hhs.gov/system/files/pdf/187581/ MedPAC and OIG have recommended PartBDrug.pdf. 25 Medicare Payment Advisory Commission. 27 Department of Health and Human Services: alternative drug payment methodologies March 2016 Report to the Congress: Medicare Office of the Assistant Secretary for Planning and Payment Policy. March 2016. Available at: http:// Evaluation. Issue Brief: Observations on Trends in 24 U.S. Department of Health and Human www.medpac.gov/docs/default-source/reports/ Prescription Drug Spending. March 8, 2016. Services, HRSA FY 2015 Budget Justification, p. chapter-3-hospital-inpatient-and-outpatient- Available at: https://aspe.hhs.gov/system/files/pdf/ 342. services-march-2016-report-.pdf?sfvrsn=0. 187586/Drugspending.pdf.
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2018 OPPS/ASC final rule with which states that if hospital acquisition MedPAC instead estimated ‘‘the lower comment period and/or through cost data are not available, the payment bound of the average discount received subregulatory guidance, including for an applicable drug shall be the by 340B hospitals for drugs paid under guidance related to billing for dually average price for the drug in the year the [OPPS]’’ (MedPAC May 2015 Report eligible beneficiaries (that is, established under section 1842(o), to Congress, page 6). Accordingly, it is beneficiaries covered under Medicare section 1847A, or section 1847B of the likely that the average discount is and Medicaid) for whom covered Act, as the case may be, as calculated higher, potentially significantly higher, entities do not receive a discount under and adjusted by the Secretary as than the average minimum of 22.5 the 340B Program. necessary. We do not have hospital percent that MedPAC found through its A summary of public comments acquisition cost data for 340B drugs analysis. In the proposed rule, we received and our responses pertaining to and, therefore, proposed to continue to encouraged the public to analyze the the modifier are included later in this pay for these drugs under our authority analysis presented in Appendix A of section. As described in detail later in at section 1833(t)(14)(A)(iii)(II) of the MedPAC’s May 2015 Report to this section, we are implementing the Act at ASP, and then to adjust that Congress. modifier such that it is required for amount by applying a reduction of 22.5 As noted earlier, we believe that the drugs that were acquired under the percent, which, as explained throughout discount amount of 22.5 percent below 340B Program instead of requiring its this section, is the adjustment we the ASP reflects the average minimum use on drugs that were not acquired believe is necessary for drugs acquired discount that 340B participating under the 340B Program. In addition, under the 340B Program. hospitals receive for drugs acquired we are establishing an informational Specifically, in the CY 2018 OPPS/ under the 340B Program, and in many modifier for use by certain providers ASC proposed rule, we proposed to cases, the average discount may be who will be excepted from the 340B apply section 1833(t)(14)(A)(iii)(II) of higher for some covered outpatient payment reduction. the Act to all separately payable drugs drugs due to hospital participation in Further, we note that the and biologicals, including SCODs. the PVP, substitution of ASP (which confidentiality of ceiling and subceiling However, we proposed to exercise the includes additional rebates) for AMP, prices limits our ability to precisely Secretary’s authority to adjust the and that drugs with pass-through calculate the price paid by 340B applicable payment rate as necessary payment status were included rather hospitals for a particular covered and, for separately payable drugs and than excluded from the MedPAC outpatient drug. We recognize that each biologicals (other than drugs with pass- analysis. We believe that a payment rate separately payable OPPS drug will have through payment status and vaccines) of ASP+6 percent does not sufficiently a different ceiling price (or subceiling acquired under the 340B Program, we recognize the significantly lower price when applicable). Accordingly, we proposed to adjust the rate to ASP acquisition costs of such drugs incurred stated in the proposed rule that we minus 22.5 percent, which we believe by a 340B-participating hospital. believe using an average discounted better represents the average acquisition Accordingly, as noted earlier, we price was appropriate for our proposal. cost for these drugs and biologicals. proposed to reduce payment for Therefore, for CY 2018, we proposed to As indicated earlier, because ceiling separately payable drugs, excluding apply an average discounted price of prices are confidential, we are unable to drugs on pass-through payment status 22.5 percent of the ASP for nonpass- publicly disclose those prices or set and vaccines, that were acquired under through separately payable drugs payment rates in a way that would the 340B Program by 22.5 percent of purchased under the 340B Program, as allow the public to determine the ASP for all drugs for which a hospital estimated by MedPAC (MedPAC’s May ceiling price for a particular drug. We does not append on the claim the 2015 Report to Congress, page 7). believe that the MedPAC analysis that modifier mentioned in the proposed In the near-term, we believe that the found the average minimum discount of rule and discussed further in this final estimated average minimum discount 22.5 percent of ASP adequately reflects rule with comment period. (As detailed MedPAC calculated—22.5 percent of the the average minimum discount that later in this section, we are instead ASP—adequately represents the average 340B hospitals paid under the OPPS requiring hospitals to append the minimum discount that a 340B receive. In addition, we believe that applicable modifier on the claim line participating hospital receives for using an average discount to set with any drugs that were acquired separately payable drugs under the payment rates for OPPS separately under the 340B Program.) OPPS. Given the limitations in payable drugs would achieve the dual Finally, as detailed in the impact calculating a precise discount for each goals of (1) adjusting payments to better analysis section (section XIX.A.5.a.2) of OPPS separately payable drug, we did reflect resources expended to acquire the proposed rule, we also proposed not attempt to do so for the proposed such drugs, and (2) protecting the that the reduced payments for rule. Instead, we stated that we believed confidential nature of discounts applied separately payable drugs and biologicals that using the analysis from the to a specific drug. Moreover, we do not purchased under the 340B Program are MedPAC report is appropriate and believe that Medicare beneficiaries included in the budget neutrality noted that the analysis is spelled out in should be liable for a copayment rate adjustments, under the requirements in detail and can be replicated by that is tied to the current methodology section 1833(t)(9)(B) of the Act, and that interested parties. As MedPAC noted, its of ASP+6 percent when the actual cost the budget neutral weight scalar is not estimate was conservative and the to the hospital to purchase the drug applied in determining payments for actual average discount experienced by under the 340B Program is much lower these separately paid drugs and 340B hospitals is likely much higher than the ASP for the drug. biologicals purchased under the 340B than 22.5 percent of the ASP. As GAO We note that MedPAC excluded Program. In that section, we also mentioned, discounts under the 340B vaccines from its analysis because solicited public comments on whether Program range from 20 to 50 percent of vaccines are not covered under the 340B we should apply all or part of the the ASP (GAO–11–836, page 2). We Program, but it did not exclude drugs savings generated by this payment believe that such reduced payment with pass-through payment status. reduction to increase payments for would meet the requirements under Further, because data used to calculate specific services paid under the OPPS, section 1833(t)(14)(A)(iii)(II) of the Act, ceiling prices are not publicly available, or under Part B generally, in CY 2018,
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rather than simply increasing the practices, cited several issues that the Medicare payments for drugs acquired conversion factor. In particular, we proposal would help address, including under the 340B Program are well in requested public comments on whether that only a small minority of 340B excess of the overhead and acquisition and how the offsetting increase could be participating hospitals are using the costs for drugs purchased under the targeted to hospitals that treat a large program to benefit patients in need; 340B Program. We continue to believe share of indigent patients, especially cancer patients in need are being denied that our proposal would better align those patients who are uninsured. In care at 340B participating hospitals or Medicare payment for separately addition, we requested public placed on wait lists; and hospitals are payable drugs acquired under the 340B comments on whether savings making extreme profits on expensive Program with the actual resources associated with this proposal would cancer drugs and are consolidating the expended to acquire such drugs. result in unnecessary increases in the nation’s cancer care system, reducing Importantly, we continue to believe that volume of covered services paid under patient choice and access and shifting Medicare beneficiaries should be able to the OPPS that should be adjusted in care away from the private, physician- share in the savings on drugs acquired accordance with section 1833(t)(2)(F) of owned community oncology clinics into through the 340B Program at a the Act. More information on the impact the more expensive 340B hospital significant discount. We also appreciate estimate associated with this proposal setting, which is increasing costs for the comments supporting the proposed was included in section XIX.A.5.a.2. of Medicare and its beneficiaries. In payment amount for drugs acquired the proposed rule. A summary of the addition, this commenter stated that the under the 340B Program of ASP minus public comments received on the increasing scope and magnitude of 22.5 percent, which we believe, like impact estimate, along with our required 340B discounts are increasing several commenters, is an amount that responses to those comments and our drug prices to record-breaking levels as allows hospitals to retain a profit on estimate of this provision for this final manufacturers factor these discounts these drugs for use in the care of low- rule with comment period, are included into pricing decisions. The commenter income and uninsured patients. As in section XVIII.A.5. of this final rule also cited a report that it recently detailed later in this section, we are with comment period. released that suggests, and provides finalizing our proposal, with anecdotal evidence supporting, that modifications, in response to public c. Summaries of Public Comments some 340B hospitals offered little comments. Received and Our Responses charity care and turned away some As previously stated, CMS does not (1) Overall Comments patients in need because those patients administer the 340B Program. were uninsured.28 Accordingly, feedback related to Comment: Several commenters, With respect to the magnitude of the eligibility for the 340B Program as well including organizations representing proposed payment reduction of ASP as 340B Program policies are outside the physician oncology practices, minus 22.5 percent, one commenter scope of the proposed rule and are not pharmaceutical research and noted that although the proposed addressed in this final rule with manufacturing companies, a large decrease in payment may seem comment period. network of community-based oncology ‘‘severe,’’ ASP minus 22.5 percent is the Comment: Several commenters practices, and several individual minimum discount that hospitals in the expressed concern with the rising cost Medicare beneficiaries, supported the 340B Program receive. The commenter of drugs and the impact on beneficiaries proposal. Some of these commenters further noted that, with 340B discounts and taxpayers. These commenters commended CMS for its proposal, on brand drugs approaching, and even offered varied opinions on whether the which they believed would help address exceeding, 50 percent, there is still proposal would achieve CMS’ goal of the growth of the 340B Program, stem substantial savings—on the order of 50 lowering drug prices and reducing physician practice consolidation with percent drug margins—for hospitals to beneficiary out-of-pocket costs. Some hospitals, and preserve patient access to use to provide direct and indirect commenters stated that the proposal has community-based care. patient benefits. The commenter also the potential to alleviate the financial One of these commenters stated that noted that this proposal would result in burden that high-cost drugs place on the proposals would reduce drug costs cost-sharing savings to Medicare patients. Other commenters stated that, for seniors by an estimated $180 million beneficiaries, for whom drug cost is an because the proposal does not address a year; help to stop hospital ‘‘abuses’’ of important component of overall the issue of expansion of 340B entities, the 340B program; and help reverse the outpatient cancer care costs. the volume of 340B discounted drugs, ‘‘perverse incentives’’ that have driven Some commenters urged HHS, and the affordability of drugs, especially the closure and consolidation of the specifically CMS and HRSA, to work oncology drugs, CMS should not nation’s community cancer care system. with Congress to reform the 340B finalize the proposal. Another commenter, representing a Program. One commenter requested One commenter, an individual who large network of community-based greater transparency and accountability supported the proposal, stated that oncology practices, noted that since on how 340B savings are being used, as although the majority of patients with 2008, 609 community cancer practices well as a specific definition of the Medicare Part B coverage have have been acquired or become affiliated ‘‘340B patient,’’ which the commenter supplemental coverage to pay their with hospitals, with 75 percent of those noted would require a legislative coinsurance, significant numbers do not community cancer practices acquired by change. have this additional protection. The 340B-participating hospitals. The Response: We thank the commenters commenter noted that, for a drug that is commenter stated that the consolidation for their support. As mentioned in the paid at $10,000 per month, the price in oncology care has resulted in a 30 proposed rule, we share the reduction would save a beneficiary percent shift in the site of service for commenters’ concern that current approximately $500 a month, which chemotherapy administration from the may be the difference between getting physician office setting to the more 28 Community Oncology Alliance. Report: ‘‘How treatment and foregoing treatment due costly hospital outpatient setting. Abuse of the 340B Program is Hurting Patients’’ September 2017. Available at: https:// to financial reasons. One commenter, an organization www.communityoncology.org/wp-content/uploads/ Another commenter, a large representing community oncology 2017/09/COA_340B-PatientStories_FINAL.pdf. organization with many members who
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are Medicare beneficiaries, stated that Response: We thank the commenters’ While the commenter’s request that the proposal would provide a measure for their feedback and share their HHS develop proposals to lower of price relief to the 16 percent of concern about the high cost of drugs and underlying drug prices is outside the Medicare beneficiaries without their effect on Medicare beneficiaries. scope of the proposals made in the supplemental coverage. The commenter As discussed in detail later in this proposed rule, we note that lowering the also expressed concern that the proposal section, we are finalizing a change to the price of pharmaceuticals is a top would have serious health implications payment rate for certain Medicare Part priority, and we are committed to for beneficiaries in safety-net hospitals. B drugs purchased by hospitals through finding ways for Medicare payment The commenter urged HHS to develop the 340B Program in order to lower the policy not to incentivize use of proposals that will lower underlying cost of drugs for seniors and ensure that overpriced drugs. With respect to drug prices, but did not provide any they benefit from the discounts Medicare Part B drug payment under specific examples of such proposals. provided through the program. We look the OPPS, we believe that reducing Another commenter stated that the cost forward to working with Congress to payments on 340B purchased drugs to of drugs is becoming unsustainable and provide HHS additional 340B better align with hospital acquisition applying the proposed policy is a decent programmatic flexibility, which could costs directly lowers drug costs for those ‘‘baby step’’ in controlling a situation include tools to provide additional beneficiaries who receive a covered that is ‘‘grossly’’ unfair to American considerations for safety net hospitals, outpatient drug from a 340B taxpayers, especially when the which play a critical role in serving our participating hospital by reducing their development of new drugs is frequently most vulnerable populations. copayments. Further, to the extent that funded to a large extent by taxpayers As a general matter, we note that, studies have found that 340B through Federal grants. even though many beneficiaries have participating hospitals tend to use more In addition, one commenter, a large supplemental coverage, beneficiaries high cost drugs, we believe that this organization representing its physician often pay a premium for such proposal helps address the incentive for and medical student members, supplemental coverage and those plans hospitals to utilize these drugs in this commented that it shares the make coinsurance payments for the manner solely for financial reasons. Administration’s interest in addressing beneficiary. Thus, to the extent The expansion of 340B entities, the the rising costs of drugs and biologicals. Medicare would be lessening the volume of 340B discounted drugs, and The commenter appreciated that the coinsurance amount such supplemental the affordability of drugs are outside the proposal would address a longstanding plans would have to make, we would authority conferred by section 1833(t) of concern: That the current payment expect the price of such plans to the Act (and, thus, are outside the scope policy for Part B drugs creates strong decrease or otherwise reflect these lower of the proposed rule), and we see no incentives to move Medicare beneficiary costs in the future, thereby lowering the reason to withdraw the proposal solely care from lower cost sites of care (such amount that beneficiaries pay for on account of these issues not being as physician offices) to higher cost sites supplemental plan coverage. Further, addressed by the proposal. Likewise, we of care (such as hospital outpatient for those Medicare beneficiaries who do note that the public comments on departments). The commenter noted not have supplemental coverage at all or Medicare Part B drug payment in the that many smaller physician practices who have a supplemental plan that does physician office setting are also outside have had to refer cancer and other not cover all of a beneficiary’s cost- the scope of the proposed rule, and, patients who need chemotherapy and sharing obligation, the proposed policy therefore, are not addressed in this final other expensive drugs to the hospital would directly lower out-of-pocket rule with comment period. outpatient setting because the ASP+6 spending for 340B-acquired drugs for Comment: Several commenters, percent payment does not always cover those beneficiaries. including organizations representing a physician’s acquisition cost, thereby In addition, we note that in the 340B-eligible safety-net hospitals in undermining continuity of care and hospital setting, not only are urban and rural areas and teaching creating burdens for frail and medically beneficiaries liable for cost-sharing for hospitals, were generally opposed to the compromised patients. drugs they receive, but they also incur proposed changes and urged CMS to This commenter also stated that, a ‘‘facility fee’’ solely because the drug withdraw the proposal from given the 340B Program’s focus on low- was furnished in the hospital setting. As consideration. As detailed further income patients, it is imperative to described in section II.A.3.b. of this below, these commenters believed that ensure that an across-the-board final rule with comment period, for CY the Secretary lacks statutory authority to reduction actually reflects the size of the 2018, we are adopting a policy to impose such a large reduction in the 340B discount to avoid creating barriers conditionally package Level 1 and Level payment rate for 340B drugs, and to access, should both physician 2 Drug Administration services and contended that such change would practices and the hospital outpatient believe that these steps, taken together, effectively eviscerate the 340B Program. departments be unable to cover actual may help encourage site-neutral care in The commenters further noted that acquisition costs. Further, the that beneficiaries may receive the same Medicare payment cuts of this commenter noted that it is essential that drugs and drug administration services magnitude would greatly ‘‘undermine ‘‘a bright line policy does not at the physician office setting without a 340B hospitals’ ability to continue inadvertently deleteriously impact significant difference in their financial programs designed to improve access to patient access in all sites of care.’’ liability between settings. services—the very goal of the 340B Finally, the commenter stated that, As previously stated, we believe that Program.’’ while the proposed policy alters the ASP minus 22.5 percent is a lower These commenters urged that, rather relative disparity between payments for bound estimate of the average discount than ‘‘punitively targeting’’ 340B safety- some hospital outpatient departments given to hospitals participating in the net hospitals serving vulnerable and physician practices, it still does not 340B Program. Accordingly, we disagree patients, including those in rural areas, address the persistent challenges that this proposal represents a ‘‘bright- CMS instead redirect its efforts to halt physician practices face in obtaining line’’ policy that would hinder safety- the ‘‘unchecked, unsustainable payment that covers acquisition costs. net hospitals’ ability to treat patients. increases’’ in the price of drugs.
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Response: We do not believe that our rate and that would result in a reduction CMS, where acquisition cost data are proposed policy ‘‘punitively’’ targets in payment to 340B hospitals of at least not available, to set payment rates by safety-net hospitals. The current OPPS $900 million, according to the agency’s reference to ASP provisions. Considered payment rate of ASP+6 percent own estimates, or $1.65 billion, in context, the commenters stated that significantly exceeds the discounts according to the commenter’s estimates. the statute reflects Congress’s intent to received for covered outpatient drugs by Another commenter stated that the limit CMS’ authority to set payment hospitals enrolled in the 340B Program, Secretary’s limited adjustment authority rates and, consequently, is consistent which can be as much as 50 percent under section 1833(t)(14)(A)(iii)(II) of with adjustment authority under below ASP (or higher through the PVP). the Act does not ‘‘extend so far as to subclause (II)—to convey only limited As stated throughout this section, ASP gut’’ what it referred to as an ‘‘explicit authority for any agency to adjust the minus 22.5 percent represents the statutory directive’’. For example, the payment rate. The commenters referred average minimum discount that 340B commenter referred the agency to to Roberts v. Sea-Land Servs., Inc., 566 enrolled hospitals paid under the OPPS Pettibone Corp. v. United States, 34 F.3d U.S. 93, 101 (2012) (Statutory provisions receive. We also have noted that 340B 536, 541 (7th Cir. 1994) (an agency’s ‘‘. . . cannot be construed in a vacuum. participation does not appear to be well- authority to interpret a statute ‘‘must not It is a fundamental canon of statutory aligned with the provision of be confused with a power to rewrite’’). construction that the words of a statute uncompensated care, as some Some commenters, including an must be read in their context and with commenters suggested. As stated earlier organization representing over 1,300 a view to their place in the overall in this section, while the commenter’s providers enrolled in the 340B Program, statutory scheme’’) to support their request that HHS develop proposals to argued that the proposal would take conclusions, although the commenters lower underlying drug prices is outside away almost the entire 340B discount did not elaborate on the particular the scope of the proposals made in the for many 340B drugs, especially brand relevance of this case. proposed rule, we note that lowering the name drugs (which they asserted were Finally, some commenters raised price of pharmaceuticals is a top many of the drugs affected by the concern over the Secretary’s use of the priority. proposal). These commenters asserted May 2015 MedPAC estimate as support that the Secretary does not have the for the 340B payment proposal. These (2) Comments on the Statutory authority to calculate and adjust 340B- commenters stated that the Secretary Authority for the 340B Payment acquired drug rates in this manner and did not conduct his own independent Proposal noted that the standard 340B ceiling analysis to support the payment Many commenters challenged the price for a brand name drug is AMP proposal nor did he provide justification statutory authority of various aspects of minus 23.1 percent, although the price for use of MedPAC’s analysis. One the proposal. These comments are can be lower if the drug’s best price is commenter stated that the Secretary summarized into the broad categories lower or if the manufacturer increases cannot implement a payment cut of the below. For the reasons stated below, we the price of the drug more quickly than magnitude proposed without providing disagree with these comments and the rate of inflation. In addition, the a sufficient and replicable methodology believe that our proposal is within our commenters asserted that if a brand that supports the proposal and that statutory authority to promulgate. name drug’s 340B ceiling price was relying on a MedPAC analysis does not based on the standard formula, the • Secretary’s Authority To Calculate suffice for this ‘‘important fiduciary, proposal would strip the hospital of and Adjust 340B-Acquired Drug and legal, requirement.’’ nearly all its 340B savings because Response: We believe our authority Payment Rates ‘‘AMP has been found to be close to under section 1833(t)(14)(A)(iii)(II) of Comment: Commenters asserted that ASP.’’ Thus, the commenters asserted, the Act to ‘‘calculate and adjust’’ drug section 1833(t)(14)(A)(iii)(II) of the Act the proposed payment rate of ASP payments ‘‘as necessary for purposes of does not authorize CMS to ‘‘calculate minus 22.5 percent is nearly identical to this paragraph’’ gives the Secretary and adjust’’ the payment rate in a AMP minus 23.1 percent, leaving the broad discretion to adjust payments for manner that would ‘‘eviscerate’’ the hospital with ‘‘virtually no 340B drugs, which we believe includes an 340B Program as it applies to 340B savings.’’ ability to adjust Medicare payment rates hospitals. Some commenters asserted Some commenters stated that the according to whether or not certain that the plain and ordinary meaning of proposal mistakenly assumes that 340B drugs are acquired at a significant the terms ‘‘calculate’’ and ‘‘adjust’’ hospitals purchase most 340B drugs at discount. We disagree that this express a limited and circumscribed subceiling prices negotiated by the PVP. Medicare payment policy would authority to set the payment rate. The These commenters noted that some effectively eviscerate the 340B Program commenters noted that the Oxford hospitals estimate that less than 10 and note that this proposal solely Dictionaries define ‘‘calculate’’ as percent of the drugs affected by the applies to applicable drug payments ‘‘determine (the amount or number of proposal are available at a subceiling under the Medicare program; it does not something) mathematically;’’ likewise, price. change a hospital’s eligibility for the to ‘‘adjust’’ is to ‘‘alter or move In addition, some commenters 340B program. Further, under our (something) slightly in order to achieve contended that subclause (I) of section proposal, we anticipate that the the desired fit, appearance, or result.’’ 1833(t)(14)((A)(iii) establishes that the Medicare payment rate would continue Consequently, the commenters asserted payment rate for subsequent years be set to exceed the discounted 340B price the that section 1833(t)(14)(A)(iii)(II) of the to the average acquisition cost of the hospital received under the 340B Act restricts the agency to drug taking into account hospital program. mathematically determining ‘‘an acquisition costs survey data collected As previously stated, MedPAC’s appropriate, slight alteration.’’ Further, through surveys meeting precise estimate of ASP minus 22.5 percent they posited that the law does not statutory requirements, and that such represents a lower bound estimate of the convey the power to adopt what they subclause does not provide adjustment average minimum discount and the referred to as a novel, sweeping change authority for the agency. They stated actual discount is likely much higher— to the payment rate that is a significant that subclause (II) of section up to 50 percent higher, according to numerical departure from the previous 1833(t)(14)((A)(iii) of the Act directs some estimates, for certain drugs. In
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some cases, beneficiary coinsurance discount that hospitals paid under the one of two ways: Using the average alone exceeds the amount the hospital OPPS received for drugs acquired under acquisition cost for the drug for that paid to acquire the drug under the 340B the 340B Program and reiterate that, in year, or using the average price for that Program (OIG November 2015, Report many instances, the discount is much drug in the year. However, in either OEI–12–14–00030, page 9). We did not higher. Thus, we are using this authority case, prices set using either benchmark receive public comments suggesting an to apply a downward adjustment that is may be adjusted by the Secretary. Such alternative minimum discount off the necessary to better reflect acquisition adjustments may occur under section ASP that would better reflect the costs of those drugs. 1833(t)(14)(A)(iii)(II) of the Act if the hospital acquisition costs for 340B- Secretary determines they are • Authority To Vary Payment by acquired drugs. We believe this is ‘‘necessary for purposes of’’ section Hospital Group notable because hospitals have their 1833(t)(14) of the Act, and this own data regarding their own Comment: Some commenters asserted paragraph of the Medicare OPPS statute acquisition costs, as well as data that only subparagraph (I), and not repeatedly discusses terms like regarding OPPS payment rates for drugs. subparagraph (II), of section ‘‘hospital acquisition cost’’ and The fact that hospitals did not submit 1833(t)(14)(A)(iii) of the Act permits ‘‘variation in hospital acquisition costs’’, comments suggesting an alternative CMS to vary payment ‘‘by hospital and specifically notes in one section minimum discount that would be a group.’’ These commenters suggested that it is within the Secretary’s authority better, more accurate reflection of the that, by including ‘‘by hospital group’’ to determine that the payment rate for discount at issue is instructive for two in subparagraph (I) and omitting it in one drug ‘‘may vary by hospital group.’’ reasons. One, it gives us confidence that subparagraph (II), Congress expressed It would be odd for Congress to have a our suggested payment of ASP minus its intent that CMS may not vary prices significant delegation of authority to the 22.5 percent is, in fact, the low bound by hospital group under subparagraph Secretary, use these specific terms and of the estimate and keeps Medicare (II). They further commented that the considerations throughout section payment within the range where subparagraph (II) methodology must 1833(t)(14) of the Act, and then assume hospitals will not be underpaid for their apply to ‘‘the drug,’’ and CMS may not the Secretary is foreclosed from taking acquisition costs of such drugs. Two, it vary payment for the same drug based into account those considerations in gives us confidence that the affected upon the type of hospital. adjusting ASP ‘‘as necessary for hospital community does not believe Response: We disagree with the purposes’’ of section 1833(t)(14) of the there is some other number, such as commenters who argue that the Act. The Secretary is generally ASP minus 24 percent or ASP minus 17 proposed policy would exceed the empowered to adjust drug prices ‘‘as percent, that would be a better, more Secretary’s authority under the statute necessary’’ for the overall purposes of accurate measure of what Medicare Part by inappropriately varying payments for section 1833(t)(14) of the Act, and there B should pay for drugs acquired at a drugs by ‘‘hospital group’’ because we is nothing in section 1833(t)(14) of the discount through the 340B Program. rely on section 1833(t)(14)(A)(iii)(II) of Act to indicate the Secretary is Given the limitations in calculating a the Act, even though the explicit foreclosed from varying Medicare OPPS precise discount for each OPPS authority to vary payment rates by payment for a drug, depending on separately payable drug, we did not hospital group is in subclause (I) of whether a 340B hospital acquired that attempt to do so for the proposed rule. section 1833(t)(14)(A)(iii) of the Act, not drug at such a substantially lower Instead, we stated that we believed that subclause (II). As noted above, we acquisition cost. using the analysis from the MedPAC believe our authority under section • Authority To Establish Payment Rates report is appropriate because MedPAC’s 1833(t)(14)(A)(iii)(II) of the Act to in the Absence of Acquisition Cost estimate is based on all drugs separately ‘‘calculate and adjust’’ drug payments Survey Data and Authority To Base paid under the OPPS except for ‘‘as necessary for purposes of this Payment on an Average Discount vaccines, which are not eligible for 340B paragraph’’ gives the Secretary broad prices. Furthermore, the analysis is discretion to adjust payments for drugs, Comment: Some commenters, publicly available and can be replicated which we believe includes an ability to including a commenter representing by interested parties. adjust payment rates according to teaching hospitals, stated that the With respect to the comments about whether or not certain drugs are Secretary ignored the statutory directive the PVP, as previously stated, by the acquired at a significant discount for in section 1833(t)(14) of the Act to set end of FY 2015, the PVP had nearly Medicare beneficiaries. Although we payment rates at the average acquisition 7,600 products available to participating acknowledge that hospitals are eligible cost for specific drugs and not to use entities below the 340B ceiling price, to receive drugs at discounted rates averages for all drugs. In addition, the including 3,557 covered outpatient under the 340B Program if they qualify commenters stated that section drugs with an estimated average savings as a ‘‘covered entity’’ for purposes of the 1833(t)(14) of the Act requires the of 10 percent below the 340B ceiling 340B Program, not all drugs for which Secretary to rely on an average of price. Participation in the PVP is a covered entity submits a claim for acquisition cost data and sales prices for voluntary and free, and we are aware of payment under the OPPS are necessarily a given drug, not an average discount no reason that an eligible entity would acquired under the 340B Program. The that is applied to all drugs acquired not participate. OPPS payment for those drugs not under the 340B Program. Furthermore, we disagree that the acquired under the 340B Program would One commenter stated that the Secretary’s authority under section continue to be paid at ASP+6 percent. Secretary impermissibly conflates the 1834(t)(14)(A)(iii)(II) of the Act to We also note generally that the OPPS two alternative methods for setting calculate and adjust drugs rates as statute authorized the Secretary to payment rates, ‘‘essentially discarding necessary is limited to what some might establish appropriate Medicare OPPS Congress’ requirement that any survey consider minor changes and find no payment rates for covered outpatient data used in setting payment rates must evidence in the statute to support that drugs. After specifically setting forth the be derived from statistically rigorous position. As previously stated, we payment methodology for 2004 and surveys.’’ This commenter asserted that believe that ASP minus 22.5 percent 2005, Congress provided that the the Secretary is using MedPAC’s represents the average minimum Secretary could set OPPS drug prices in estimate of average discounts as a proxy
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or replacement for the surveys required overhead payment for drugs and means we are permanently barred from under subsection (iii)(I). biologicals.’’ Moreover, the commenters adjusting these payments where, as Response: We disagree that section added, CMS has applied the statutory here, we have provided a reasoned 1833(t)(14)(A)(iii)(II) of the Act requires default rate without further adjustment explanation for doing so. We continue use of survey data and note that, unlike in each subsequent year. They asserted to believe, as the commenter noted, that subclause (I) of this section, subclause that the CY 2018 proposal, in contrast, ASP+6 percent requires no further (II) does not require taking survey data departs dramatically from longstanding adjustment for drugs that are not into account for determining average prior practice and adopts a substantially acquired under the 340B Program price for the drug in the year. We reduced payment rate of ASP minus because, at this time, we have not found continue to believe that section 22.5 percent for drugs acquired under a similar evidence of the difference 1833(t)(14)(A)(iii)(II) of the Act grants 340B Program. between the statutory benchmark the Secretary the authority to calculate Response: As discussed in the earlier (ASP+6 percent) and average hospital and adjust rates as necessary in the background section, section acquisition costs for such drugs. absence of acquisition cost. Moreover, 1833(t)(14)(A)(iii)(II) of the Act grants However, that is not the case for 340B- under section 1833(t)(14)(A) of the Act, the Secretary authority to adjust, as acquired drugs. As explained in detail there still will be one starting, baseline necessary for purposes of paragraph (14) throughout this section, we believe that price for an applicable drug, that is, the of section 1833(t) of the Act, the a payment amount of ASP minus 22.5 rate that applies under 1842(o), 1847A, applicable payment rate for separately percent for drugs acquired under the or section 1847B, as the case may be, as payable covered outpatient drugs under 340B Program is better aligned to calculated and adjusted by the the OPPS. Specifically, we believe that hospitals’ acquisition costs and thus this Secretary. For drugs not acquired under the proposed reduced payment for adjustment, for drugs acquired under the 340B Program, we will continue to 340B-acquired drugs would meet the the 340B Program, is necessary for utilize that price (ASP+6 percent), requirements under section Medicare OPPS payment policy. which as we have explained ‘‘requires 1833(t)(14)(A)(iii)(II) of the Act, which • no further adjustment’’ because it states that if hospital acquisition cost Violation of Section 340B of the ‘‘represents the combined acquisition data are not available, the payment for Public Health Service Act and pharmacy overhead payment for an applicable drug shall be the average Comment: Some commenters stated drugs and biologicals.’’ However, for price for the drug in the year established that the proposed payment reduction drugs acquired through the 340B under section 1842(o), section 1847A, or would violate the 340B statute, which Program, we are adjusting that price section 1847B of the Act, as the case expressly defines the types of hospitals downward (ASP minus 22.5 percent) to may be, as calculated and adjusted by that may receive the benefits of 340B more closely align with the hospital the Secretary as necessary for purposes discounts. One commenter asserted that acquisition cost for a drug when of this paragraph (paragraph (14) of the payment proposal would ‘‘hijack purchased at a discounted price under section 1833(t) of the Act) (emphasis Congress’ carefully crafted statutory the 340B Program. In the absence of added). We do not have hospital scheme by seizing 340B discounts from acquisition costs from hospitals that acquisition cost data for 340B drugs hospitals and transferring the funds to purchase drugs through the 340B and, therefore, we proposed to continue providers that Congress excluded from Program, we believe it is appropriate to to pay for these drugs under the the 340B Program,’’ thereby violating exercise our authority to adjust the methodology in our authority at section section 340B of the Public Health average price for 340B-acquired drugs, 1833(t)(14)(A)(iii)(II) of the Act which Service Act. The commenter further which are estimated to be acquired at an we determined to be ASP, and then to noted that discounts under the 340B average minimum discount of ASP adjust that amount by applying a Program are only available to ‘‘covered minus 22.5 percent. Importantly, reduction of 22.5 percent to that entities’’ that are defined by law and because we are not using authority payment methodology, which, as that Congress thus intended the benefits under section 1833(t)(14)(A)(iii)(I) of the explained throughout this section, is the of the program to accrue to these Act (as the commenter suggested), we adjustment we believe is necessary to providers only. The commenter disagree with the commenter’s more closely align with the acquisition contended that Congress’ reference to suggestion that the Secretary is using costs for drugs acquired under the 340B Medicare definitions when describing the MedPAC analysis to stand in the Program. covered entities demonstrates that it place of the survey requirement under As previously stated, we believe that considered the Medicare program when subclause (I). using an average discount to set it adopted the 340B Program and • payment rates for separately payable decided not to grant discounts to all Current Agency View Contrasts With 340B-acquired drugs will achieve the Medicare hospitals. Rather, the Longstanding Practice dual goals of (1) adjusting payments to commenter believed that Congress made Comment: Some commenters better reflect resources expended to a deliberate decision to limit the contended that the proposal contrasts acquire such drugs and (2) protecting benefits of the 340B Program only to sharply with the agency’s previous view the confidential nature of discounts Medicare hospitals that serve large and longstanding practice of applying applied to a specific drug. Furthermore, numbers of low-income or other the statutory scheme of section our proposed and finalized policy will underprivileged patients. In addition, 1833(t)(14) of the Act. These lower OPPS payment rates for Medicare the commenter stated that when commenters noted that since CMS began beneficiaries who receive drugs at Congress has intended Federal health relying on subclause (II) in 2012 to set hospitals subject to the 340B payment care programs to intrude upon the 340B the payment rate, the agency has never reduction. Program, it has been crystal clear. invoked the discretionary authority. The In addition, we do not believe that the In contrast, commenters asserted that commenters stated that, instead, CMS fact that we have not historically Congress has been wholly silent on the stated that the statutory default of utilized our adjustment authority under relationship between 340B and ASP+6 percent ‘‘requires no further section 1833(t)(14)(A)(iii)(II) of the Act Medicare Part B, which indicates adjustment’’ because it ‘‘represents the to adjust payment amounts for Congress’s intent that Medicare should combined acquisition and pharmacy separately payable 340B-acquired drugs not ‘‘encroach’’ upon the 340B Program
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by ‘‘redistributing [340B] discounts to corroborate the commenters’ belief that • Proposal Is Procedurally Defective non-340B providers.’’ The commenters Congress’ silence on the relationship and Inconsistent With Advisory Panel noted that the 340B statute and between 340B and Medicare Part B Recommendations Medicare have coexisted for several OPPS payments should be viewed as Comment: Some commenters years and that Congress has had ample constraining the Secretary’s ability contended that the proposal is opportunity to amend the Medicare under section 1833(t)(14) of the Act as procedurally defective under the OPPS statute governing Part B payments and/ to how to calculate payment rates for statute. The commenters asserted that or the 340B statute to expressly permit drugs acquired under the 340B Program the Secretary’s justification for the CMS to reduce Medicare payments to under the OPPS. While legislative proposed reduced rate rests, in part, on 340B hospitals, but has not done so. As silence can be difficult to interpret, we intertwined issues related to clinical use an example, the commenters cited note that Congress’ silence regarding the and hospital cost of drugs. The legislation enacted in 2010, in which 340B Program in enacting Medicare commenters objected to CMS’ reference Congress amended both the 340B and OPPS payment for certain drugs would to studies suggesting that 340B hospitals the Medicare statutes, but did not create the opposite inference. The 340B may be unnecessarily prescribing more authorize CMS to redistribute 340B Program existed well before Congress drugs and/or more expensive drugs savings to non-340B hospitals or to Part enacted the Medicare OPPS and relative to non-340B hospitals as B generally. payment for certain drugs. If Congress support for proposing a payment rate Commenters further asserted that the wanted to exempt 340B drugs or entities that eliminates the differential between proposed cut to 340B hospitals is also with a 340B agreement from Medicare acquisition cost and Medicare payment. contrary to Congress’s intent for the OPPS payment for drugs generally, it These commenters cited other studies in 340B Program to enable safety-net easily could have done so. Instead, an effort to refute the evidence providers to reach more patients and Congress provided for Medicare OPPS presented in the proposed rule.29 30 The furnish more comprehensive services drug payments ‘‘as calculated and commenters believed that CMS should and would undermine this purpose by adjusted by the Secretary as necessary,’’ have asked the HOP Panel to consider preventing the operation of the 340B without any mention of, or restriction the intertwined issues of drug cost and statute. These commenters suggested regarding, the already existent 340B clinical use prior to making a proposal that, although manufacturers would still Program. to reduce payment for 340B-acquired have to give 340B discounts, 340B We also disagree with commenters drugs, and the Secretary should have participating hospitals would receive no who believe that implementing the consulted with the HOP Panel in benefit from those discounts; thus, the OPPS payment methodology for 340B- accordance with section 1833(t)(9)(A) of statutory purpose of 340B would be acquired drugs as proposed will the Act, as part of the process of review fatally undermined. ‘‘eviscerate’’ or ‘‘gut’’ the 340B Program. and revision of the payment groups for Response: We do not believe that this As discussed earlier in the background covered outpatient department services proposal under section 1833(t) of the section, the findings from several 340B and the relative payment weights for the Act is in conflict with section 340B of studies conducted by the GAO, OIG, groups. The commenters argued that, the Public Health Service Act. Section and MedPAC show a wide range of because the Secretary did not consult 1833(t) of the Act governs Medicare discounts that are afforded to 340B with the HOP Panel before publishing payment policies for covered hospital hospitals, with some reports finding its 340B payment proposal, the outpatient department services paid discounts of up to 50 percent. As stated Secretary acted contrary to the statute. under the OPPS, while section 340B of in the proposed rule, we believe ASP The commenters noted that at the the Public Health Service Act governs minus 22.5 percent is a conservative August 21, 2017 meeting of the HOP eligibility and program rules for estimate of the discount for 340B- Panel that occurred after publication of participation in the 340B Program. acquired drugs and that even with the the proposed rule, the Panel urged that There are no references in either section reduced payment, hospitals will CMS not finalize the proposed payment of law to each other. In fact, the failure continue to receive savings that can be reduction. of either statute to reference the other directed at programs and services to At the August 21, 2017 meeting of the proves the opposite—that each statute carry out the intent of the 340B HOP Panel, the Panel made the stands on its own and neither is Program. following recommendations with hindered or rendered null and void by With respect to the comment that the respect to the proposed policy for OPPS the other. There is no requirement in the proposal would frustrate the intent of payment for drugs acquired under the Public Health Service Act that the 340B the 340B Program and redirect Medicare 340B Program: Program ‘‘guarantee’’ or provide a payments to other hospitals that do not The Panel recommended that CMS: certain profit from the Medicare participate in the 340B Program, we • Not finalize its proposal to revise program. Likewise, there is no reiterate that we proposed to the payment rate for drugs purchased requirement in section 1833(t) of the Act redistribute the savings in an equal and under the 340B Program; to pay a particular rate for a hospital offsetting manner to all hospitals paid • Collect data from public comments enrolled in the 340B Program. We agree under the OPPS, including those in the and other sources, such as State with the commenters that Congress was 340B Program, in accordance with the aware of both the 340B Program and the budget neutrality requirements under 29 Dobson Davanzo & Associates, Update to a OPPS and of the programs’ relationships section 1833(t)(9)(B) of the Act. 2012 Analysis of 340B Disproportionate Share to one another. However, we believe However, we remain interested in Hospital Services Delivered to Vulnerable Patient that the silence of each statute with exploring ways to better target the Populations Eligibility Criteria for 340B DSH Hospitals Continue to Appropriately Target Safety respect to the other should not be offsetting amount to those hospitals that Net Hospitals (Nov. 15, 2016). Available at: http:// viewed as a constraint on the broad serve low-income and uninsured www.340bhealth.org/files/Update_Report_FINAL_ authority conferred to the Secretary patients, as measured by 11.15.16.pdf. under section 1833(t) of the Act to uncompensated care. Details on the 30 Dobson DaVanzo, Analysis of the Proportion of 340B DSH Hospital Services Delivered to Low- establish payment rates under the OPPS. redistribution of funds are included in Income Oncology Drug Recipients Compared to Furthermore, we are unaware of section XVIII. of this final rule with Non-340B Provider (2017). Available at: http:// legislative history or other evidence to comment period. www.340bhealth.org/files/LowIncomeOncology.pdf;
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Medicaid programs in Texas and New uncompensated care and is associated of possible mechanisms for York, on the potential impact of revising with differences in prescribing patterns redistributing the ‘‘savings’’ (or the the payment rate, implementing a and drug costs. For example, as noted dollars that result) from changing the modifier code, and the effects of earlier in this section, GAO found that payment rate and have assessed the possible mechanisms for redistributing ‘‘in both 2008 and 2012, per beneficiary regulatory burden of changing the the savings that result from changing the Medicare Part B drug spending, payment rate and the potential impact payment rate; and including oncology drug spending, was on 340B hospitals of redistributing • Assess the regulatory burden of substantially higher at 340B DSH dollars saved, all of which were steps changing the payment rate and the hospitals than at non-340B hospitals,’’ the HOP Panel recommended we take. potential impact on 340B hospitals of thus indicating that, on average, Regarding the comments asserting redistributing dollars saved. beneficiaries at 340B DSH hospitals that the Secretary is out of compliance In addition, one commenter suggested were either prescribed more drugs or with procedures used to promulgate that the proposal was ‘‘procedurally more expensive drugs than beneficiaries regulations as described under section defective’’ because the proposal was at the other non-340B hospitals in 1871 of the Act (42 U.S.C. 1395hh), we solely articulated through preamble and GAO’s analysis. note that we have received public did not propose to amend the Code of With respect to the HOP Panel, we comments on our interpretation of the Federal Regulations (CFR). The believe that this comment reflects a Medicare statute, and we respond to commenter asserted that the proposal misunderstanding of the Panel’s role in those comments above. We further note cannot be implemented without a advising the Secretary. Section that we did not establish in the Code of change to the Medicare regulations and 1833(t)(9)(A) of the Act provides that Federal Regulations the rates for stated that the Medicare statute requires the Secretary shall consult with an separately payable, nonpass-through CMS to issue regulations when altering expert outside advisory panel composed drugs and biologicals in past the substantive standards for payment.31 of an appropriate selection of rulemakings. Because we have not The commenter stated that the proposal representatives of providers to review adopted regulation text that prescribes falls squarely within this requirement (and advise the Secretary concerning) the specific payment amounts for because it would change the substantive the clinical integrity of the groups and separately payable, nonpass-through legal standard governing payments to weights. Such panel may use data drugs and biologicals, there was no 340B hospitals for separately payable collected or developed by entities and regulation text to amend to include our drugs. organizations (other than the proposed payment methodology for Another commenter stated that CMS’ Department of Health and Human drugs acquired under the 340B Program. proposal also violates section Services) in conducting such review. However, this does not mean that 1833(t)(2)(E) of the Act because the The provisions described under payment rates for separately payable agency is not authorized and did not section 1833(t)(9)(A) of the Act do not drugs were not available to the public. offer a reasoned basis for applying impose an obligation on the Secretary to That information is available in savings achieved as a result of its consult with the HOP Panel prior to Addendum B to this final rule with proposal to reduce significantly issuing a notice of proposed rulemaking comment period, which lists the payments to 340B hospitals to Part B nor do they require the Secretary to national payment rates for services paid services generally. Likewise, a few adopt the Panel’s recommendation(s). under the OPPS, including the payment commenters stated that the Rather, the statute provides that the rates for separately payable drugs and Administrative Procedure Act (APA) Secretary shall consult with the Panel biologicals based on ASP+6 percent. We requires the Secretary to offer a on policies affecting the clinical note that we have not provided the ‘‘reasoned basis’’ for proposing to take integrity of the ambulatory payment reduced payment rates for separately an unprecedented action. The classifications and their associated payable drugs and biologicals acquired commenters suggested that, as a matter weights under the OPPS. The Secretary under the 340B Program in Addendum of longstanding policy and practice, the met the requirement of section B, but hospitals can arrive at those rates Secretary has never applied such a 1833(t)(9)(A) of the Act at the HOP using the ASP+6 percent rate that is sweeping change to drug rates nor has Panel August 21, 2017 meeting in which included in Addendum B. Finally, with it ever applied savings from OPPS the Panel made recommendations on respect to comments on redistribution of outside of the OPPS. this very proposed policy. The HOP the dollars that result from the 340B Response: We remind the commenters Panel’s recommendations, along with payment policy, we are finalizing our that our proposal was based on findings public comments to the proposed rule, proposal to achieve budget neutrality for that ASP minus 22.5 percent reflects the have all been taken into consideration the payment reduction for 340B- minimum average discount that in the development of this final rule acquired drugs through an increase in hospitals in the 340B Program receive. with comment period. the conversion factor. We disagree that We are familiar with the reports the While we are not accepting the HOP our proposal to apply budget neutrality commenters referenced in their Panel’s recommendation not to finalize in accordance with section 1833(t)(9)(B) comments. However, we continue to the payment reduction for drugs of the Act violates the APA or statutory believe, based on numerous studies and purchased under the 340B Program, as authority. Further, we note that if we reports, that 340B participation is not discussed later in this section, we are decide to take a different approach with well correlated to the provision of modifying our position on the modifier respect to the redistribution of funds for in an effort to ease administrative budget neutrality in the future, we will 31 ‘‘No rule, requirement, or other statement of burden on providers, taking into consider such approach in future policy (other than a national coverage account the way in which the modifier determination) that establishes or changes a rulemaking. is used in several State Medicaid substantive legal standard governing the scope of • benefits, the payment for services, or the eligibility programs, as the Panel recommended. In Impact on Medicare Beneficiary Cost- of individuals, entities, or organizations to furnish addition, we have collected data from Sharing or receive services or benefits under this subchapter public comments on the potential Comment: Some commenters noted shall take effect unless it is promulgated by the Secretary by regulation. . . .’’ Section 1871 of the impact of revising the payment rate, that Medicare beneficiaries, including Social Security Act (42 U.S.C. 1395hh). implementing a modifier, and the effects dual-eligible Medicare beneficiaries,
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would not directly benefit from a decrease in payments to 340B hospitals a recommendation to the Congress that lowered drug copayment amount. The of approximately 2.6 percent, or savings from the reduced payment rates commenters noted that many approximately $800 million. The be directed to the Medicare-funded beneficiaries have supplemental commenter asserted that CMS’ proposal uncompensated care pool, which would insurance that covers their out-of-pocket would remove $800 million intended to target hospitals providing the most care drug costs, in whole or in part. These support what it referred to as the to the uninsured, and in that way commenters asserted that the proposal congressionally mandated mission of benefit indigent patients, and that would actually increase their out-of- 340B hospitals from these already payments be distributed in proportion pocket costs for other Part B benefits. vulnerable facilities and redistribute to the amount of uncompensated care Response: The cost-sharing obligation these dollars to other hospitals that do that hospitals provide. MedPAC for Medicare beneficiaries is generally not participate in the 340B Program. believed that legislation would be 20 percent of the Medicare payment Likewise, the commenter challenged needed to direct drug payment savings rate. While many Medicare beneficiaries CMS’ suggested alternative approaches to the uncompensated care pool and may have supplemental coverage that to achieving budget neutrality, such as noted that current law requires the covers some or all of their out-of-pocket applying offsetting savings to specific savings to be retained with the OPPS to expenses, not all beneficiaries have such services within the OPPS or outside of make the payment system budget coverage. This policy will lower both the OPPS to Part B generally (such as to neutral. MedPAC encouraged the the amount that a beneficiary is physician services under the Medicare Secretary to work with Congress to responsible to pay as well as the amount Physician Fee Schedule), which the enact legislation necessary to allow that any supplemental insurance, commenter believed would similarly MedPAC’s recommendation to be including the Medicaid program, will penalize these most vulnerable hospitals implemented, if such recommendation pay on behalf of the beneficiary. While and inhibit their efforts to carry out the could not be implemented we are implementing this policy in a purpose of the 340B Program. Finally, administratively. MedPAC further noted budget neutral manner equally across other commenters noted that that legislation would also allow the OPPS for CY 2018 for non-drug implementing the proposed policy in a Medicare to apply the policy to all items and services, we may revisit how non-budget neutral manner would OPPS separately payable drugs, any savings from the lowered drug effectively ‘‘gut’’ the 340B Program. including those on pass-through payment rate for 340B drugs may be Response: With respect to comments payment status. allocated in the future and continue to on the proposed distribution of savings, be interested in ways to better target the we refer readers to section XVIII. of this Response: We thank MedPAC for its savings to hospitals that serve the 2018 OPPS/ASC final rule with comments and for its clarification that uninsured and low-income populations comment for discussion on the its recommendation that ‘‘[t]he Congress or that provide a disproportionate share redistribution of savings that result from should direct the Secretary of the of uncompensated care. the estimated impact of the 340B policy Department of Health and Human In addition, as noted earlier in this as well as calculation of budget Services to reduce Medicare payment section, in the hospital setting, not only neutrality. Briefly, for CY 2018, we are rates for 340B hospitals’ separately are beneficiaries liable for cost-sharing implementing the alternative payment payable 340B drugs by 10 percent of the for drugs they receive, but they also methodology for drugs purchased under average sales price (ASP)’’ was intended incur a ‘‘facility fee’’ solely because the the 340B Program in a budget neutral to be 10 percent lower than the current drug was furnished in the hospital manner within the OPPS through an Medicare rate of ASP+6 percent and setting. As described in section II.A.3.b. offsetting increase in the conversion would result in a final OPPS payment of this final rule with comment period, factor for nondrug services. Therefore, of ASP minus 5.3 percent when taking for CY 2018, we are adopting a policy the resulting savings from the 340B the sequester into account. However, we to conditionally package Level 1 and payment policy will be redistributed pro do not believe that reducing the Level 2 drug administration services rata through an increase in rates for non- Medicare payment rate by only 10 and believe that these steps taken drug items and services under the percentage points below the current together may help encourage site- OPPS. We have already addressed payment rate of ASP+6 percent (that is, neutral care in that beneficiaries may comments relating to the assertion that ASP minus 4 percent) would better receive the same drugs and drug our proposal would ‘‘gut’’ or reflect the acquisition costs incurred by administration services at the physician ‘‘eviscerate’’ the 340B Program. 340B participating hospitals. In its May office setting without a significant Likewise, we have addressed the 2015 Report to the Congress, MedPAC difference in their financial liability interaction between our authority under estimated that the average minimum between settings. section 1833(t)(14)(A) of the Act relative discount for a 340B hospital paid under • Calculation of Savings to section 340B of the Public Health the OPPS was ASP minus 22.5 percent, Comment: Commenters disagreed Service Act in our responses above. which it noted was a conservative, with CMS’ impact estimate and a few ‘‘lower bound’’ estimate. Further, in its commenters provided their own (3) Other Areas March 2016 Report to the Congress, analysis of the 340B drug payment Comment: MedPAC commented MedPAC stated that, ‘‘[i]n aggregate, the proposal. One commenter believed that reiterating its recommendations to Office of Inspector General (OIG) even if CMS implements the policy as Congress in its March 2016 Report to the estimates that discounts across all 340B proposed, in a budget neutral manner Congress. Specifically, MedPAC providers (hospitals and certain clinics) within the OPPS through an offsetting commented that it recommended that average 34 percent of ASP, allowing increase in the conversion factor, payment rates for all separately payable these providers to generate significant payments for non-drug APCs would drugs provided in a 340B hospital profits when they administer Part B increase across hospitals by should be reduced to 10 percent of the drugs (MedPAC March 2016 Report to approximately 3.7 percent (in contrast ASP rate (resulting in ASP minus 5.3 Congress, page 76). MedPAC further to CMS’ estimate of 1.4 percent). percent after taking application of the noted the estimate of the aggregate According to the commenter, this sequester into account). MedPAC noted discount was based on all covered redistribution would result in a net that its March 2016 report also included entities (hospitals and certain clinics).
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Because 340B hospitals accounted for used profit margins on 340B-acquired reduction in drug payment for 340B 91 percent of Part B drug spending for drugs to offset uncompensated care and purchased drugs. Moreover, all covered entities in 2013, it is staff emergency departments. In commenters suggested that the proposal reasonable to assume that 340B addition, the commenters stated that a disproportionately impacts rural hospitals received a discount similar to portion of rural hospitals are excluded hospitals compared to its effect on 33.6 percent of ASP (MedPAC March from purchasing orphan drugs through urban hospitals. 2016 Report to Congress, page 79). the 340B Program. Therefore, the Finally, commenters requested that, if Further, as we stated in the proposed commenters stated, these hospitals often CMS finalizes the policy as proposed, rule, the GAO reported that the amount use their 340B savings to offset the CMS exempt hospitals with a RRC or of the 340B discount ranges from an expense of purchasing orphan drugs, SCH designation from the alternative estimated 20 to 50 percent discount, which they note comprise a growing 340B drug payment policy. The compared to what the entity would have number of new drug approvals. commenters asserted that RRCs and otherwise paid to purchase the drug. In In addition, a commenter representing SCHs are rural safety-net hospitals that addition, voluntary participation in the several 340B-enrolled hospitals stated provide localized care for Medicare PVP results in a covered entity paying that multiple hospitals report that the beneficiaries and also serve as a subceiling price on certain covered 340B Program is the reason the hospital ‘‘economic engines’’ for many rural outpatient drugs (estimated to be can provide oncology infusions in their communities. approximately 10 percent below the local community and that the Response: We share commenters’ ceiling price). (U.S. Department of chemotherapy infusion centers tend to concerns about access to care, especially Health and Human Services, HRSA FY be small with variation in patients in rural areas where access issues may 2018 Budget Justification) served based on the needs of the be even more pronounced than in other Accordingly, we continue to believe community. The commenter stated that, areas of the country. We note our that ASP minus 22.5 percent represents without the 340B Program, many rural proposal would not alter covered a conservative estimate of the average hospitals would likely need to stop entities’ access to the 340B Program. minimum discount that 340B-enrolled providing many of the outpatient The alternative 340B drug payment hospitals paid under the OPPS receive infusions, thereby forcing patients to methodology solely changes Medicare for drugs purchased with a 340B either travel 35 miles (in the case of payment for 340B-acquired drugs. Program discount and that hospitals SCHs which must generally be located Medicare has long recognized the likely receive an even steeper discount at least 35 miles from the nearest like particularly unique needs of rural on many drugs, especially brand name hospital) to another facility or receive communities and the financial drugs. We also continue to believe that care in a hospital inpatient setting, challenges rural hospital providers face. section 1833(t)(14)(A)(iii)(II) of the Act which is a more costly care setting. Across the various Medicare payment allows the Secretary to make Another commenter, a member of systems, CMS has established a number adjustments, if hospital acquisition cost Congress representing a district in the of special payment provisions for rural data is not available, as necessary, so State of Ohio, commented that while the providers to maintain access to care and that the Medicare payment rate better 340B Program is in need of reform, the to deliver high quality care to represents the acquisition cost for drugs program remains an important safety net beneficiaries in rural areas. With respect and biologicals that have been acquired for rural hospitals in Ohio and around to the OPPS, section 1833(t)(13) of the with a 340B discount. the country. The commenter stated that Act provided the Secretary the authority With respect to MedPAC’s comment 340B hospitals offer safety-net programs to make an adjustment to OPPS regarding targeting the savings to to their communities, including opioid payments for rural hospitals, effective uncompensated care, we refer readers to treatment programs, behavioral health January 1, 2006, if justified by a study section XVIII.A.5. of this final rule with science programs, and others. The of the difference in costs by APC comment period. commenter further stated that the 340B between hospitals in rural areas and • Comments Regarding Rural drug payment proposal did not address hospitals in urban areas. Our analysis Hospitals broader structural issues with the 340B showed a difference in costs for rural Comment: Commenters representing Program itself, including lack of SCHs. Therefore, for the CY 2006 OPPS, rural hospitals, particularly RRCs and oversight and clear guidance and we finalized a payment adjustment for SCHs, expressed opposition to the definitions, and that the proposal could rural SCHs of 7.1 percent for all services proposal, noting that it could be harm the hospitals that the 340B and procedures paid under the OPPS, especially harmful to rural hospitals in Program was intended to help. In excluding separately payable drugs and light of the ‘‘hospital closure crisis.’’ addition, the commenter noted that biologicals, brachytherapy sources, and One commenter cited a report from a ‘‘arbitrary cuts’’ to the 340B Program for devices paid under the pass-through health analytics company and noted safety-net hospitals could have payment policy, in accordance with that since 2010, 80 rural hospitals have detrimental impacts on the economic section 1833(t)(13)(B) of the Act. We closed and that one-third of remaining growth and opportunities in the have continued this 7.1 percent rural hospitals are vulnerable to closure, communities those hospitals serve and payment adjustment since 2006. with 41 percent of rural hospitals that the proposal does not advance the In the CY 2018 OPPS/ASC proposed operating at a financial loss. larger goals of 340B Program reform. rule, we sought public comment for Commenters noted that rural hospitals One commenter noted that SCHs face future policy refinements on whether, enrolled in the 340B Program depend on 47.5 percent higher levels of bad debt due to access to care issues, exceptions the drug discounts to provide access to and 55 percent lower profit margins. should be granted to certain groups of expensive, necessary care such as labor Thus, even with 340B discounts, the hospitals, such as those with special and delivery and oncology infusions. commenter argued that rural hospitals adjustments under the OPPS (for The commenters stated that rural like rural SCHs are financially example, rural SCHs or PPS-exempt Americans are more likely to be older, threatened. Commenters also noted that cancer hospitals) if a policy were sicker, and poorer than their urban rural hospitals are typically located in adopted to adjust OPPS payments for counterparts. The commenter gave lower income economic areas and are drugs acquired under the 340B program. examples of rural hospitals that have not able to absorb the proposed Taking into consideration the comments
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regarding rural hospitals, we believe vulnerable and underserved patients In summary, we are adopting for CY further study on the effect of the 340B and communities, undermining these 2018 an exemption for rural SCHs, drug payment policy is warranted for hospitals’ ability to continue providing children’s hospitals, and PPS-exempt classes of hospitals that receive programs designed to improve access to cancer hospitals from the alternative statutory payment adjustments under services. The commenter believed that 340B drug payment methodology. These the OPPS. In particular, given assumptions alluded to in the CY 2018 three types of hospitals will not be challenges such as low patient volume, OPPS/ASC proposed rule, which subject to a reduced drug payment for it is important that we take a closer look suggested that providers are abusing the drugs that are purchased under the 340B at the effect of an ASP minus 22.5 savings generated from the 340B Program in CY 2018. We may revisit the percent payment on rural SCHs. Program or potentially creating specific types of hospitals excluded, if With respect to RRCs, we note that incentives to over utilize drugs, are any, from the 340B payment policy in there is no special payment designation inaccurate and that clinicians provide CY 2019 rulemaking. However, as for RRCs under the OPPS. By definition, the care that is necessary to treat a discussed in more detail below, it RRCs must have at least 275 beds and patient’s disease. The commenter remains important to collect therefore are larger relative to rural suggested that CMS work with, or defer information on which drugs being billed SCHs. In addition, RRCs are not subject to, HRSA to first conduct a complete to Medicare were acquired under the to a distance requirement from other analysis of how the 340B Program is 340B Program. Accordingly, these three hospitals. Accordingly, at this time, we utilized for the benefit of patients prior types of hospitals will still be required are not exempting RRCs from the 340B to proposing any changes to Medicare to report an informational modifier payment adjustment. payment for drugs purchased through ‘‘TB’’ for tracking and monitoring For CY 2018, we are excluding rural the program. purposes. We may revisit this 340B drug SCHs (as described under the Response: We share the commenters’ payment policy, including whether regulations at 42 CFR 412.92 and views on protecting access to high these types of hospitals should continue designated as rural for Medicare quality care for all Medicare to be excepted from the reduced purposes) from this policy. We may beneficiaries, including those treated in Medicare payment rate, in future revisit our policy to exempt rural SCHs, children’s or PPS-exempt cancer rulemaking. as well as other hospital designations • hospitals. Further, because of how these Biosimilar Biological Products for exemption from the 340B drug Comment: Some commenters classes of hospitals are paid under the payment reduction, in the CY 2019 expressed opposing views about OPPS, we recognize that the 340B drug OPPS rulemaking. applying the proposed 340B payment payment proposal may not result in methodology to biosimilar biological • Children’s and PPS-Exempt Cancer reduced payments for these hospitals in products. One pharmaceutical Hospitals the aggregate. manufacturer recommended that the Comment: Commenters representing Specifically, in accordance with Secretary use his equitable adjustment children’s hospitals (‘‘children’s’’) section 1833(t)(7)(D)(ii) of the Act, we authority at section 1833(t)(2)(E) of the raised objections to the proposal make transitional outpatient payments Act to apply a narrow equitable because of the potential impact on the (TOPs) to both children’s and PPS- adjustment to biosimilar biological approximate 8,000 children with end- exempt cancer hospitals. That is, these products with pass-through payment stage renal disease (ESRD) who are hospitals are permanently held harmless status to pay for these drugs at ASP eligible for Medicare. One commenter to their ‘‘pre-BBA amount,’’ and they minus 22.5 percent of the reference cited that currently 48 children’s receive hold harmless payments to product rather than ASP+6 percent of hospitals participate in the 340B ensure that they do not receive a the reference product. The commenter Program and rely on the savings the payment that is lower in amount under asserted that excluding biosimilar program provides to enhance care for the OPPS than the payment amount biological products from the alternative vulnerable children. According to the they would have received before 340B payment methodology would commenter, pediatric ESRD patients implementation of the OPPS. result in a significant payment require high levels of care and rely on Accordingly, if we were to reduce drug differential between biosimilar life-saving pharmaceuticals that often payments to these hospitals on a per biological products and reference come at a high cost. Therefore, the claim basis, it is very likely that the products which may cause providers to commenters posited that it is because reduction in payment would be paid switch patients to different products for children’s patients are more expensive back to these hospitals at cost report financial reasons, rather than clinical to treat and not because of inappropriate settlement, given the TOPs structure. factors. The commenter stated that, if drug use that 340B hospitals incur Accordingly, we believe it is the policy is implemented as proposed, higher drug expenditures. In addition, appropriate to exempt children’s and the competitive biosimilar marketplace the commenters expressed concern with PPS-exempt cancer hospitals from the would significantly change because the effect the 340B drug payment policy alternative 340B drug payment Medicare would pay more for the may have on State Medicaid programs, methodology for CY 2018. Therefore, for biosimilar biological product with pass- considering Medicaid is the CY 2018, we are excluding children’s through payment status and weaken predominant payer type for children’s and PPS-exempt cancer hospitals from market forces. The commenter estimated hospitals. The commenters requested the alternative 340B drug payment that if the 340B drug policy is that, unless CMS is able to examine the policy. As discussed in a later section in implemented as proposed, up to $50 impact on pediatric Medicare this final rule with comment period, million of any savings could be lost due beneficiaries, CMS should exempt because we are redistributing the dollars to hospitals switching to the biosimilar children’s hospitals from the alternative in a budget neutral manner within the biological product on pass-through 340B drug payment methodology. OPPS through an offsetting increase to payment status (that will be paid at An organization representing PPS- the conversion factor, children’s ASP+6 percent of the reference exempt cancer hospitals commented hospitals and PPS-exempt cancer product). Moreover, the commenter that CMS’ proposal would severely hospitals will receive a higher payment pointed out that CMS’ policy to only harm the hospitals that treat the most when providing a non-drug service. provide pass-through payments for the
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first eligible biosimilar biological transitional drug pass-through payment Response: We appreciate the product of any reference biological under section 1833(t)(6)(D)(i) of the Act commenter’s concerns about potential would also create a similar payment provides for an explicit payment for unintended consequences of our disadvantage for any subsequent drugs eligible for pass-through payment. proposal. We will continue to monitor biosimilar biological product, which Therefore, we are unable to accept the the billing patterns of claims submitted would be ineligible for pass-through commenter’s request to pay a biosimilar by nonexcepted off-campus outpatient payment under CMS’ policy. biological product on pass-through PBDs as we continue to explore whether Another commenter, a different payment status the reduced 340B to pursue future rulemaking on the pharmaceutical manufacturer, requested payment rate. We are adopting a policy issues of clinical service line expansion that CMS exclude biosimilar biological that any biosimilar biological product or volume increases, and other related products from the proposed payment with pass-through payment status will section 603 implementation policies. adjustment until such time as the be exempt from the alternative payment In the CY 2017 OPPS/ASC final rule biosimilar biological product market is methodology for 340B drugs and will with comment period, we discussed the better established. The commenter continue to be paid at ASP+6 percent of provision of section 603 of the indicated that while a biosimilar the reference product. Biosimilar Bipartisan Budget Act of 2015 (Pub. L. biological product is less expensive to biological products that are not on pass- 144–74), enacted on November 2, 2015, the Medicare program, hospitals are through payment status will be paid which amended section 1833(t) of the incented by the 340B Program to ASP minus 22.5 percent of the reference Act. Specifically, this provision purchase the originator product because product. We believe it is appropriate to amended the OPPS statute at section of ‘‘the spread’’ or payment differential pay this amount for biosimilar 1833(t) by amending paragraph (1)(B) with respect to the originator product. biological products as it is consistent and adding a new paragraph (21). As a Moreover, the commenter stated that with the amount paid for non-340B- general matter, under sections applying the proposed adjustment to acquired biosimilar biological products, 1833(t)(1)(B)(v) and (t)(21) of the Act, payment for biosimilar biological which is ASP+6 percent of the reference applicable items and services furnished products in certain hospitals will retain product. Currently, there are two by certain off-campus outpatient market share for the more expensive biosimilar biological products available departments of a provider on or after reference product that is further on the market and both are on pass- January 1, 2017, are not considered compounded by market practices of through payment status for the entirety covered outpatient department services volume-based rebates and exclusionary of CY 2018. Therefore, no biosimilar as defined under section 1833(t)(1)(B) of contracts for the reference product. biological products currently available the Act for purposes of payment under Response: We understand the will be affected by the alternative the OPPS and are instead paid ‘‘under commenters’ concerns. As discussed in payment methodology for 340B- the applicable payment system’’ under section V.B.2. of this CY 2018 OPPS/ acquired drugs for CY 2018. We Medicare Part B if the requirements for ASC final rule with comment period, we recognize the concerns about paying such payment are otherwise met (81 FR are adopting the biosimilar biological different rates for similar drugs and 79699). We issued an interim final rule products HCPCS coding established biologicals and continue to assess the with comment period along with the CY under the CY 2018 MPFS final rule. feasibility and practicality of an 2017 OPPS/ASC final rule with Briefly, we adopted a final policy to alternative 340B payment adjustment comment period to establish the MPFS establish separate HCPCS codes for each for biosimilar biological products in the as the ‘‘applicable payment system,’’ biosimilar biological product for a future. which will apply in most cases, and particular reference product beginning • Nonexcepted Off-Campus Hospital payment rates under the MPFS for non- January 1, 2018. In addition, we also Outpatient Departments excepted items and services furnished stated in section V.B.2. of this CY 2018 Comment: A few commenters noted by nonexcepted off-campus outpatient OPPS/ASC final rule with comment that CMS’ proposed alternative payment provider based departments (PBDs) (81 period that we are making a conforming methodology for 340B purchased drugs FR 79720). (Other payment systems, amendment to our pass-through would not apply to nonexcepted off- such as the Clinical Laboratory Fee payment policy for biosimilar biological campus provider-based departments Schedule, continue to apply in products such that each FDA-approved (PBDs) of a hospital and could result in appropriate cases.) That is, items and biosimilar biological product will be behavioral changes that may undermine services furnished by nonexcepted off- eligible for transitional pass-through CMS’ policy goals of reducing campus outpatient PBDs, are payment instead of only the first beneficiary cost-sharing liability and nonexcepted items and services that are biosimilar for a particular reference undercut the goals of section 603 of the not covered outpatient services, and product. Bipartisan Budget Act of 2015. thus, are not payable under the OPPS. Therefore, given the policy changes Commenters recommended that, if CMS Rather, these nonexcepted items and affecting coding and payment for adopts a final policy to establish an services are paid ‘‘under the applicable biosimilar biological products that we alternative payment methodology for payment system,’’ which, in this case, is are adopting in the CY 2018 MPFS final 340B drugs in CY 2018, CMS also apply generally the MPFS. rule and this CY 2018 OPPS/ASC final the same adjustment to payment rates As we discussed in the CY 2017 rule with comment period, we disagree for drugs furnished in nonexcepted off- OPPS/ASC interim final with comment with the commenters that we should campus PBDs of a hospital if such drugs period (81 FR 79718) and reiterated in exclude biosimilar biological products are acquired under the 340B Program. In the CY 2018 MPFS final rule, payment from the 340B payment policy or use addition, the commenters believed that for Part B drugs that would be our equitable adjustment authority because CMS did not propose to limit separately payable under the OPPS under section 1833(t)(2)(E) of the Act to the expansion of services or volume (assigned status indicator ‘‘K’’) but are adjust payment to ASP minus 22.5 increases at excepted off-campus PBDs, not payable under the OPPS because percent of the reference product for CMS will create financial incentives for they are furnished by nonexcepted off- biosimilar biological products with hospitals to shift or reallocate services campus outpatient PBDs will be paid in pass-through payment status. We to the site of care that pays the highest accordance with section 1847A of the believe the statutory provision on rate for an item or service. Act (generally, ASP+6 percent),
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consistent with Part B drug payment communicate with—the hospital’s are correctly interpreted by State policy in the physician office. We did pharmacy drug dispensing and patient Medicaid programs so that they can not propose to adjust payment for 340B- billing systems. While these software appropriately request manufacturer acquired drugs in nonexcepted off- tools enable split-billing to distinguish rebates on drugs not purchased under campus PBDs in CY 2018 but may 340B and non-340B patients, the the 340B Program. Moreover, some consider adopting such a policy in CY commenters noted that this patient commenters believed that if CMS 2019 notice-and-comment rulemaking. determination is typically not done in required the modifier to be reported for • Data Collection and Modifier real time when a drug is administered. 340B-purchased drugs, State Medicaid Comment: The vast majority of Commenters noted that 340B hospitals programs would also adopt the commenters objected to CMS’ intention that use split-billing software do not modifier, leading to national uniformity to require hospitals that do not purchase receive information on 340B patient in reporting of 340B drugs. a drug or biological through the 340B status on a daily basis and the proposal Finally, in the event that CMS program to apply a modifier to avoid a could result in delayed billing. The required the modifier on claims for reduced drug payment. A few commenters stated that hospitals 340B drugs, rather than non-340B drugs, commenters supported the modifier typically make these determinations commenters sought clarity on whether proposal. The commenters who retrospectively and it may be 3 to 10 the modifier applies only to drugs disagreed with proposal stated that it days post-dispensing before the hospital purchased under the 340B Program would place an unnecessary knows whether a drug was replenished which are subject to a ceiling price administrative and financial burden on under 340B or at regular pricing. The payment from the manufacturer or if the hospitals that do not participate or are commenters noted that, under this modifier would also apply to drugs not eligible to participate in the 340B ‘‘replenishment model,’’ hospitals track purchased by a 340B-registered facility, Program. Similarly, the commenters how many 340B-eligible drugs are used, but purchased under the Prime Vendor stated that the modifier requirement as and once enough drugs are dispensed to Program for which only 340B facilities described in the proposed rule would complete a package, they will replenish are eligible. One commenter asked that put a financial and administrative strain the drug at the 340B rate. As such, the CMS emphasize that 340B pricing is not on hospitals with fewer resources. In commenters argued that hospitals do available on drugs furnished to hospital addition, the commenters contended not know when the drug is dispensed inpatients. that a requirement for hospitals to report whether it will cost them the 340B rate Response: We appreciate the detailed a modifier for drugs that were not or the wholesale acquisition cost comments that were submitted. As acquired under the 340B Program would (WAC). Therefore, the commenters noted in the proposed rule, we did not place hospitals at significant risk for expressed concern that the modifier propose to establish the modifier but noncompliance if not implemented requirement as described in the rather noted our intent to establish the correctly, which many commenters proposed rule would result in billing modifier, regardless of whether we believe is nearly impossible to do. As an delays and, for some hospitals, may adopted the alternative payment alternative approach, numerous cause a short-term interruption in cash methodology for drugs acquired through commenters recommended that CMS flow. the 340B Program. However, we are require hospitals that do purchase a In addition, the commenters responding to some of the comments drug under the 340B Program to report requested that, while the payment submitted in this final rule with the modifier, rather than those that do reduction would apply to nonpass- comment period with information on not. through separately payable drugs this modifier that we believe is Regarding a January 1, 2018, purchased with a 340B discount, CMS important to communicate as soon as implementation date for the modifier, accept the modifier when reported with possible. We will consider whether some commenters expressed concern drug HCPCS codes that are packaged additional details will need to be and doubted their ability to implement (and for which no separate payment will communicated through a subregulatory the modifier as described in the be made) to reduce or prevent process, such as information posted to proposed rule accurately. The operational burden that may be caused the CMS Web site. commenters indicated that additional if affected providers have to determine After considering the administrative time would be needed to adapt billing on a claim-by-claim basis whether a and financial challenges associated with systems, allow for testing of claims drug is eligible for separate payment. providers reporting the modifier as reported with the modifier, and educate With respect to State Medicaid described in the CY 2018 OPPS/ASC staff. Based on discussion of how the programs that also require a modifier to proposed rule, and in order to reduce modifier would work in the proposed identify 340B-purchased drugs on regulatory burden, we are reversing our rule, the commenters stated that outpatient claims, the commenters position on how the modifier will be hospitals would either have to append noted that CMS’ proposal would be used by providers to effectuate the the modifier to the claim at the time the counter to Medicaid requirements and payment adjustment for 340B-purchased drug is furnished, or retroactively apply would create confusion and add drugs. the modifier, thus delaying claims complexity for providers who treat Specifically, beginning January 1, submission to Medicare. Medicaid recipients in multiple states. 2018, providers who are not excepted The commenters provided detailed The commenters reported that many from the 340B payment adjustment will descriptions on hospital pharmacy set State Medicaid programs require a report modifier ‘‘JG’’ (Drug or biological up, including information on software modifier to identify drugs that were acquired with 340B Drug Pricing tools to support inventory management purchased under 340B to administer Program Discount) to identify if a drug of drugs dispensed to 340B and non- their Medicaid drug rebate programs to was acquired under the 340B Program. 340B patients (based on HRSA prevent duplicate discounts on 340B This requirement is aligned with the definition of an eligible patient). One drugs. The commenters suggested that if modifier requirement already mandated commenter indicated that the drug CMS reversed its position on in several States under their Medicaid supply system used for purchasing application of the modifier, it would programs. Therefore, we believe that covered outpatient drugs is completely ensure crossover claims (claims this option will pose less of an separate from—and does not necessarily transferred from Medicare to Medicaid) administrative burden. Further, having
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consistent application of the modifier July 13, 2017 that we intended to reported on the claim is available upon being required for a drug that was establish a modifier to implement the request. purchased under the 340B Program policy for payment of drugs acquired d. Summary of Final Policies for CY instead of a drug not purchased under under the 340B Program, if finalized. In 2018 the 340B Program will help improve addition, the modifier will not be program integrity by helping ensure that required until January 1, 2018, which In summary, for CY 2018, in hospitals are not receiving ‘‘duplicate after display of this final rule with accordance with section discounts’’ through both the Medicaid comment period will give hospitals two 1833(t)(14)(A)(iii)(II) of the Act, rebate program and the 340B Program. additional months to operationalize the separately payable Part B drugs The phrase ‘‘acquired under the 340B modifier. Under section 1835(a) of the (assigned status indicator ‘‘K’’), other Program’’ is inclusive of all drugs Act, providers have 12 months after the than vaccines and drugs on pass- acquired under the 340B Program or date of service to timely file a claim for through payment status, that meet the PVP, regardless of the level of discount payment. Therefore, for those hospitals definition of ‘‘covered outpatient drug’’ applied to the drug. Drugs that were not that may need more time to ensure that as defined in the section 1927(k) of the acquired under the 340B Program they are in compliance with the Act, that are acquired through the 340B should not be reported with the modifier requirements, they have 12 Program or through the 340B PVP at or modifier ‘‘JG’’. For separately payable months from the date of service to do so. below the 340B ceiling price will be drugs (status indicator ‘‘K’’), application Further, to the extent many hospitals paid at the ASP minus 22.5 percent of modifier ‘‘JG’’ will trigger a payment already report a modifier through their when billed by a hospital paid under adjustment such that the 340B-acquired State Medicaid program, we believe that the OPPS that is not excepted from the drug is paid at ASP minus 22.5 percent. also requiring the modifier on payment adjustment. Part B drugs or In response to the commenters’ request outpatient claims for 340B-acquired biologicals excluded from the 340B that we allow the 340B modifier to be drugs paid for under the OPPS would payment adjustment include vaccines reported with status indicator ‘‘N’’ drugs not be a significant administrative (assigned status indicator ‘‘L’’ or ‘‘M’’) (that is, drugs that are always packaged), burden and would promote consistency and drugs with OPPS transitional pass- we will accept modifier ‘‘JG’’ or ‘‘TB’’ to between the two programs. With respect through payment status (assigned status be reported with a packaged drug to providers in States that are not indicator ‘‘G’’). Medicare will continue (although such modifier will not result currently required to report a modifier to pay drugs that were not purchased in a payment adjustment). under the Medicaid program, we note with a 340B discount at ASP+6 percent. In addition, beginning January 1, that providers are nonetheless Effective January 1, 2018, biosimilar 2018, providers that are excepted from responsible for ensuring that drugs are biological products not on pass-through the 340B drug payment policy for CY furnished to ‘‘covered patients’’ under payment status that are purchased 2018, which include rural SCHs, the 340B Program and, therefore, should through the 340B program or through children’s hospitals, and PPS-exempt already have a tracking mechanism in the 340B PVP will be paid at ASP minus cancer hospitals, should not report place to ensure that they are in 22.5 percent of the reference product’s modifier ’’JG’’. Instead, these excepted compliance with this requirement. ASP, while biosimilar biological providers should report the Furthermore, modifiers are commonly products on drug pass-through payment informational modifier ‘‘TB’’ (Drug or used for payment purposes; in this case, status will continue to be paid ASP+6 Biological Acquired With 340B Drug the presence of the modifier will enable percent of the reference product. Pricing Program Discount, Reported for us to pay the applicable 340B drug rate To effectuate the payment adjustment Informational Purposes) to identify of ASP minus 22.5 percent and track for 340B-acquired drugs, CMS is OPPS separately payable drugs these claims in the Medicare data (in the implementing modifier ‘‘JG’’, effective purchased with a 340B discount. The case of ‘‘JG’’ modifier) and will allow us January 1, 2018. Hospitals paid under informational modifier ‘‘TB’’ will to track other drugs billed on claims that the OPPS, other than a type of hospital facilitate the collection and tracking of are not subject to the payment reduction excluded from the OPPS (such as CAHs 340B claims data for OPPS providers (modifier ‘‘TB’’). In addition, the or those hospitals paid under the that are excepted from the payment presence of the both modifiers will Maryland waiver) or excepted from the adjustment in CY 2018. However, use of enable Medicare and other entities to 340B drug payment policy for CY 2018, modifier ‘‘TB’’ will not trigger a conduct research on 340B-acquired are required to report modifier ‘‘JG’’ on payment adjustment and these drugs in the future. the same claim line as the drug HCPCS providers will receive ASP+6 percent We remind readers that our 340B code to identify a 340B-acquired drug. for separately payable drugs furnished payment policy applies to only OPPS For CY 2018, rural SCHs, children’s in CY 2018, even if such drugs were separately payable drugs (status hospitals and PPS-exempt cancer acquired under the 340B Program. indicator ‘‘K’’) and does not apply to hospitals will be excepted from the For drugs administered to dual- vaccines (status indicator ‘‘L’’ or ‘‘M’’), 340B payment adjustment. These eligible beneficiaries (that is, or drugs with transitional pass-through hospitals will be required to report beneficiaries covered under both payment status (status indicator ‘‘G’’). informational modifier ‘‘TB’’ for 340B- Medicare and Medicaid) for whom Finally, Federal law permits Medicare acquired drugs, and will continue to be covered entities do not receive a to recover its erroneous payments. paid ASP+6 percent. discount under the 340B Program, the Medicare requires the return of any To maintain budget neutrality within State Medicaid programs should be payment it erroneously paid as the the OPPS, the estimated $1.6 billion in aware of modifier ‘‘JG’’ to help further primary payer. Medicare can also fine reduced drug payments from adoption prevent inappropriate billing of providers for knowingly, willfully, and of this final alternative 340B drug manufacturer rebates. repeatedly billing incorrectly coded payment methodology will be With respect to comments about claims. Providers are required to submit redistributed in an equal offsetting timing to operationalize a modifier, we accurate claims, maintain current amount to all hospitals paid under the note that hospitals have been on notice knowledge of Medicare billing policies, OPPS through increased payment rates since the proposed rule went on display and ensure all documentation required for non-drug items and services at the Office of the Federal Register on to support the validity of the services furnished by all hospitals paid under
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the OPPS for CY 2018. Specifically, the payments to 340B participating In addition, one commenter redistributed dollars will increase the hospitals (if so, describe how adjusted recommended that CMS develop a conversion factor across non-drug rates rates for drugs purchased under the process for stakeholders to request by 3.2 percent for CY 2018. 340B Program would disproportionately exemptions from the alternative 340B We may revisit the alternative 340B affect access in these provider settings); payment methodology that CMS would drug payment methodology in CY 2019 (2) whether other types of drugs, such evaluate using objective patient rulemaking. as blood clotting factors, should also be guidelines designed to ensure patient e. Comment Solicitation on Additional excluded from the reduced payment; access. Response: We appreciate the 340B Considerations and (3) whether hospital-owned or affiliated ASCs have access to 340B comments. To the extent that blood As discussed above, we recognize discounted drugs. clotting factors and there are data limitations in estimating We received feedback on a variety of radiopharmaceuticals are covered the average discount for 340B drugs. In issues in response to the comment outpatient drugs purchased under the the CY 2018 OPPS/ASC proposed rule solicitation on additional future 340B Program, we believe that the OPPS (82 FR 33634 through 33635), we considerations. These comments are payment rate for these drugs should welcomed stakeholder input with regard summarized below. account for the discounted rate under to MedPAC’s May 2015 analysis and the Comment: One commenter which they were purchased. Therefore, resulting estimate of ASP minus 22.5 recommended that CMS establish an for CY 2018, OPPS payment for percent as the proposed payment rate exemption mechanism for use by separately payable, nonpass-through for separately payable, nonpass-through stakeholders to request exemptions for drugs, biologicals, and OPPS drugs purchased under the 340B certain groups of hospitals. The radiopharmaceuticals, including blood Program in CY 2018. We also requested commenters urged CMS to propose and clotting factors and comment on whether we should adopt seek comment on specific guidelines radiopharmaceuticals, if purchased a different payment rate to account for that outline procedures for stakeholders through the 340B Program, will be paid the average minimum discount of OPPS to request an exemption and the criteria at ASP minus 22.5 percent. As we stated drugs purchased under the 340B CMS would use to determine whether to in the summary of final policies, we Program. Also, we sought comment on grant an exception. may revisit the 340B drug payment whether the proposal to pay ASP minus Response: We appreciate the policy in the CY 2019 rulemaking. We 22.5 percent for 340B-acquired drugs comment. As we stated in the summary will consider these requests for should be phased in over time (such as of final policies, we may revisit the exceptions for certain drug classes in over a period of 2 to 3 years). 340B drug payment policy in the CY development of the CY 2019 OPPS/ASC In addition, we recognize that the 2019 rulemaking. For CY 2018, as stated proposed rule. acquisition costs for drugs may vary earlier in this section, rural SCHs, It is unclear to us whether the among hospitals, depending on a children’s hospitals and PPS-exempt commenter meant that number of factors such as size, patient cancer hospitals will be excepted from radiopharmaceuticals are not volume, labor market area and case-mix. the alternative 340B drug payment considered covered outpatient drugs Accordingly, in the longer term, we are methodology being adopted in this final under the OPPS or not considered a interested in exploring ways to more rule with comment period. However, covered outpatient drug for purposes of closely align the actual acquisition costs each of these excepted providers will the 340B Program. We assume the that hospitals incur rather than using an report informational modifier ‘‘TB’’ on commenter was referring to the average minimum discounted rate that the same claim line as the HCPCS code definition of covered outpatient drug for would apply uniformly across all 340B for their 340B-acquired drugs. purposes of the 340B Program and, as hospitals. In the proposed rule, we Comment: In response to the such, these comments are outside the requested public comment on whether, solicitation of comments on whether scope of the CY 2018 OPPS/ASC as a longer term option, Medicare CMS should exclude certain types of proposed rule. We refer commenters to should require 340B hospitals to report drugs from the proposed alternative HRSA with questions related to the their acquisition costs in addition to 340B drug payment methodology, 340B Program. charges for each drug on the Medicare manufacturers of blood clotting factors Comment: One commenter claim. Having the acquisition cost on a and radiopharmaceuticals representing community oncology drug-specific basis would enable us to recommended that CMS continue to pay practices urged CMS not to ‘‘reduce the pay a rate under the OPPS that is these drug types at ASP+6 percent. With size of the reimbursement reduction’’ or directly tied to the acquisition costs for respect to blood clotting factors, the to phase in the adjustment over 2 to 3 each separately payable drug. To the commenters stated that individuals with years because the commenter believed extent that the acquisition costs for bleeding disorders have unique needs that hospitals would use that time to some drugs may equal the ceiling price and are expensive to treat such that the ‘‘aggressively strong-arm independent for a drug, we recognize that there may proposed reduced payment could community oncology practices to sell be challenges with keeping the ceiling threaten access and/or create out to them.’’ price confidential as required by section unnecessary treatment delays for these Response: As stated earlier in this 1927(b)(3)(D) of the Act and we sought patients. With respect to section, we are finalizing our proposal comment on this point. radiopharmaceuticals, the commenters to pay ASP minus 22.5 percent for Lastly, for consideration for future stated that they do not believe that these separately payable nonpass-through policy refinements, we requested public products are covered outpatient drugs drugs (other than vaccines). In addition, comment on (1) whether, due to access (because it is not possible for the we agree that it is not necessary to phase to care issues, exceptions should be manufacturer to accurately report final in the payment reduction and are granted to certain groups of hospitals, dose and pricing information), and implementing the full adjustment for CY such as those with special adjustments therefore these drugs should be 2018. under the OPPS (for example, rural excluded as a category of drugs Comment: Commenters expressed SCHs or PPS-exempt cancer hospitals) if included in the covered drug definition concern about the challenges and costs a policy were adopted to adjust OPPS for the 340B Program. of implementing acquisition cost billing.
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The commenters reported that hospital prospective payment year is budget amount by which the amount charge masters are not designed to bill neutral, as required by section authorized under section 1842(o) of the drugs to one payer at a different rate 1833(t)(6)(E) of the Act. Act (or, if the drug or biological is than other payers. The commenters For devices, developing an estimate of covered under a competitive acquisition cited a survey response from hospitals pass-through spending in CY 2018 contract under section 1847B of the Act, that revealed acquisition cost billing entails estimating spending for two an amount determined by the Secretary would require investment in expensive groups of items. The first group of items equal to the average price for the drug software upgrades, obtaining a second consists of device categories that are or biological for all competitive charge master, or devising burdensome currently eligible for pass-through acquisition areas and year established manual workarounds. One commenter payment and that will continue to be under such section as calculated and stated that hospital cost reports already eligible for pass-through payment in CY adjusted by the Secretary) exceeds the reflect the 340B acquisition cost based 2018. The CY 2008 OPPS/ASC final rule portion of the otherwise applicable fee on expenses reported in the pharmacy with comment period (72 FR 66778) schedule amount that the Secretary cost center. The commenter further describes the methodology we have determines is associated with the drug stated that these lower costs are already used in previous years to develop the or biological. Because we proposed to reflected in the drug CCR, which will pass-through spending estimate for pay for most nonpass-through separately likely be lower because the cost to known device categories continuing into payable drugs and biologicals under the acquire these drugs is lower. Thus, the the applicable update year. The second CY 2018 OPPS at ASP+6 percent, and commenter asserted, the OPPS group of items consists of items that we because we proposed to pay for CY 2018 ratesetting process already reflects a know are newly eligible, or project may pass-through drugs and biologicals at blend of discounting/lower expenses be newly eligible, for device pass- ASP+6 percent, as we discussed in with respect to 340B drug acquisition in through payment in the remaining section V.A. of the proposed rule, our the annual application of CCRs to quarters of CY 2017 or beginning in CY estimate of drug and biological pass- pharmacy charges. 2018. The sum of the CY 2018 pass- through payment for CY 2018 for this Response: We thank the commenters through spending estimates for these group of items was $0, as discussed for their feedback and will take these two groups of device categories equals below. In the proposed rule, we noted comments into consideration for future the total CY 2018 pass-through spending that our estimate did not reflect the policymaking. We note that several estimate for device categories with pass- proposed payment policy for drugs State Medicaid programs require through payment status. We base the purchased through the 340B program, as reporting of actual acquisition cost device pass-through estimated payments we discussed in section V.A. of the (AAC) for 340B drugs so the magnitude for each device category on the amount proposed rule. of payment as established in section of the challenges to implement may be Furthermore, payment for certain less than the commenter suggests. 1833(t)(6)(D)(ii) of the Act, and as outlined in previous rules, including the drugs, specifically diagnostic VI. Estimate of OPPS Transitional Pass- CY 2014 OPPS/ASC final rule with radiopharmaceuticals and contrast Through Spending for Drugs, comment period (78 FR 75034 through agents without pass-through payment Biologicals, Radiopharmaceuticals, and 75036). We note that, beginning in CY status, is packaged into payment for the Devices 2010, the pass-through evaluation associated procedures, and these products will not be separately paid. In A. Background process and pass-through payment for implantable biologicals newly approved addition, we policy-package all Section 1833(t)(6)(E) of the Act limits for pass-through payment beginning on nonpass-through drugs, biologicals, and the total projected amount of or after January 1, 2010, that are radiopharmaceuticals that function as transitional pass-through payments for surgically inserted or implanted supplies when used in a diagnostic test drugs, biologicals, (through a surgical incision or a natural or procedure and drugs and biologicals radiopharmaceuticals, and categories of orifice) use the device pass-through that function as supplies when used in devices for a given year to an process and payment methodology (74 a surgical procedure, as discussed in ‘‘applicable percentage,’’ currently not FR 60476). As has been our past practice section II.A.3. of the proposed rule and to exceed 2.0 percent of total program (76 FR 74335), in the CY 2018 OPPS/ this final rule with comment period. In payments estimated to be made for all ASC proposed rule (82 FR 33635), we the CY 2018 OPPS/ASC proposed rule covered services under the OPPS proposed to include an estimate of any (82 FR 33635 through 33636), we furnished for that year. If we estimate implantable biologicals eligible for pass- proposed that all of these policy- before the beginning of the calendar through payment in our estimate of packaged drugs and biologicals with year that the total amount of pass- pass-through spending for devices. pass-through payment status would be through payments in that year would Similarly, we finalized a policy in CY paid at ASP+6 percent, like other pass- exceed the applicable percentage, 2015 that applications for pass-through through drugs and biologicals, for CY section 1833(t)(6)(E)(iii) of the Act payment for skin substitutes and similar 2018. Therefore, our estimate of pass- requires a uniform prospective products be evaluated using the medical through payment for policy-packaged reduction in the amount of each of the device pass-through process and drugs and biologicals with pass-through transitional pass-through payments payment methodology (76 FR 66885 payment status approved prior to CY made in that year to ensure that the through 66888). Therefore, as we did 2018 was not $0, as discussed below. In limit is not exceeded. We estimate the beginning in CY 2015, for CY 2018, we section V.A.5. of the proposed rule, we pass-through spending to determine also proposed to include an estimate of discussed our policy to determine if the whether payments exceed the any skin substitutes and similar costs of certain policy-packaged drugs applicable percentage and the products in our estimate of pass-through or biologicals are already packaged into appropriate prorata reduction to the spending for devices. the existing APC structure. If we conversion factor for the projected level For drugs and biologicals eligible for determine that a policy-packaged drug of pass-through spending in the pass-through payment, section or biological approved for pass-through following year to ensure that total 1833(t)(6)(D)(i) of the Act establishes the payment resembles predecessor drugs or estimated pass-through spending for the pass-through payment amount as the biologicals already included in the costs
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of the APCs that are associated with the knew at the time of the development of between payment for the policy- drug receiving pass-through payment, the proposed rule will be newly eligible packaged drug or biological at ASP+6 we proposed to offset the amount of for pass-through payment in CY 2018; percent (or WAC+6 percent, or 95 pass-through payment for the policy- additional device categories that we percent of AWP, if ASP or WAC packaged drug or biological. For these estimated could be approved for pass- information is not available) and the drugs or biologicals, the APC offset through status subsequent to the policy-packaged drug APC offset amount is the portion of the APC development of the proposed rule and amount, if we determine that the policy- payment for the specific procedure before January 1, 2018; and contingent packaged drug or biological approved performed with the pass-through drug projections for new device categories for pass-through payment resembles a or biological, which we refer to as the established in the second through fourth predecessor drug or biological already policy-packaged drug APC offset quarters of CY 2018. In the CY 2018 included in the costs of the APCs that amount. If we determine that an offset OPPS/ASC proposed rule (82 FR 33636), are associated with the drug receiving is appropriate for a specific policy- we proposed to use the general pass-through payment. For the proposed packaged drug or biological receiving methodology described in the CY 2008 rule, using the proposed methodology pass-through payment, we proposed to OPPS/ASC final rule with comment described above, we calculated a CY reduce our estimate of pass-through period (72 FR 66778), while also taking 2018 proposed spending estimate for payments for these drugs or biologicals into account recent OPPS experience in this first group of drugs and biologicals by this amount. approving new pass-through device of approximately $7.7 million. Similar to pass-through spending categories. For the proposed rule, the We did not receive any public estimates for devices, the first group of estimate of CY 2018 pass-through comments on our proposed spending drugs and biologicals requiring a pass- spending for this second group of device estimate for this first group of drugs and through payment estimate consists of categories was $10 million. biologicals. For this final rule with those products that were recently made We did not receive any public comment period, using the latest eligible for pass-through payment and comments on our proposed estimate for available data, we calculated a CY 2018 that will continue to be eligible for pass- the second group of devices. For this spending estimate for this first group of through payment in CY 2018. The final rule with comment period, using drugs and biologicals of approximately second group contains drugs and the latest available data, we calculated $9.83 million. We note that this estimate biologicals that we know are newly a CY 2018 spending estimate for this does not reflect drugs purchased with a eligible, or project will be newly eligible second group of devices of $10 million. 340B discount and therefore subject to in the remaining quarter of CY 2017 or To estimate proposed CY 2018 pass- a payment reduction based on final beginning in CY 2018. The sum of the through spending for drugs and policy for CY 2018. CY 2018 pass-through spending biologicals in the first group, To estimate proposed CY 2018 pass- estimates for these two groups of drugs specifically those drugs and biologicals through spending for drugs and and biologicals equals the total CY 2018 recently made eligible for pass-through biologicals in the second group (that is, pass-through spending estimate for payment and continuing on pass- drugs and biologicals that we knew at drugs and biologicals with pass-through through payment status for CY 2018, we the time of development of the proposed payment status. proposed to use the most recent rule were newly eligible for pass- Medicare hospital outpatient claims through payment in CY 2018, additional B. Estimate of Pass-Through Spending data regarding their utilization, drugs and biologicals that we estimated In the CY 2018 OPPS/ASC proposed information provided in the respective could be approved for pass-through rule (82 FR 33636), we proposed to set pass-through applications, historical status subsequent to the development of the applicable pass-through payment hospital claims data, pharmaceutical the proposed rule and before January 1, percentage limit at 2.0 percent of the industry information, and clinical 2017, and projections for new drugs and total projected OPPS payments for CY information regarding those drugs or biologicals that could be initially 2018, consistent with section biologicals to project the CY 2018 OPPS eligible for pass-through payment in the 1833(t)(6)(E)(ii)(II) of the Act and our utilization of the products. second through fourth quarters of CY OPPS policy from CY 2004 through CY For the known drugs and biologicals 2018), we proposed to use utilization 2017 (81 FR 79676 through 79678). (excluding policy-packaged diagnostic estimates from pass-through applicants, For the first group, consisting of radiopharmaceuticals, contrast agents, pharmaceutical industry data, clinical device categories that are currently drugs, biologicals, and information, recent trends in the per eligible for pass-through payment and radiopharmaceuticals that function as unit ASPs of hospital outpatient drugs, will continue to be eligible for pass- supplies when used in a diagnostic test and projected annual changes in service through payment in CY 2018, there are or procedure, and drugs and biologicals volume and intensity as our basis for no active categories for CY 2018. that function as supplies when used in making the CY 2018 pass-through Because there are no active device a surgical procedure) that will be payment estimate. We also proposed to categories for CY 2018, we proposed an continuing on pass-through payment consider the most recent OPPS estimate for the first group of devices of status in CY 2018, we estimated the experience in approving new pass- $0. pass-through payment amount as the through drugs and biologicals. Using We did not receive any public difference between ASP+6 percent and our proposed methodology for comments on our proposed estimate for the payment rate for nonpass-through estimating CY 2018 pass-through the first group of devices. For this final drugs and biologicals that will be payments for this second group of rule with comment period, using the separately paid at ASP+6 percent, drugs, we calculated a proposed latest available data, we calculated a CY which is zero for this group of drugs. spending estimate for this second group 2018 spending estimate for this first Because payment for policy-packaged of drugs and biologicals of group of devices of $0. drugs and biologicals is packaged if the approximately $8.5 million. In estimating our proposed CY 2018 product was not paid separately due to We did not receive any public pass-through spending for device its pass-through payment status, we comments on our proposed categories in the second group, we proposed to include in the CY 2018 methodology or the proposed spending included: Device categories that we pass-through estimate the difference estimate for this second group of drugs.
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Therefore, for CY 2018, we are We did not receive any public hospitalization services (65 FR 18444 continuing to use the general comments on our proposals for CY through 18445). methodology described earlier. For this 2018. Therefore, we are finalizing our Section 1833(t)(2)(C) of the Act final rule with comment period, based proposal, without modification, to requires the Secretary, in part, to on the latest available data, we continue our current clinic and ED establish relative payment weights for calculated a CY 2018 spending estimate hospital outpatient visits and critical covered outpatient department (OPD) for this second group of drugs and care services payment policies. We also services (and any groups of such biologicals of approximately $8.23 did not receive any public comments on services described in section million. any changes to these codes that we 1833(t)(2)(B) of the Act) based on In summary, in accordance with the should consider for future rulemaking median (or, at the election of the methodology described earlier in this cycles. Secretary, mean) hospital costs using section, for this final rule with comment data on claims from 1996 and data from VIII. Payment for Partial the most recent available cost reports. In period, we estimate that total pass- Hospitalization Services through spending for the device pertinent part, section 1833(t)(2)(B) of categories and the drugs and biologicals A. Background the Act provides that the Secretary may that are continuing to receive pass- establish groups of covered OPD through payment in CY 2018 and those A partial hospitalization program services, within a classification system device categories, drugs, and biologicals (PHP) is an intensive outpatient developed by the Secretary for covered that first become eligible for pass- program of psychiatric services OPD services, so that services classified through payment during CY 2018 is provided as an alternative to inpatient within each group are comparable approximately $28.06 million psychiatric care for individuals who clinically and with respect to the use of (approximately $10 million for device have an acute mental illness, which resources. In accordance with these provisions, we have developed the PHP categories and approximately $18.06 includes, but is not limited to, APCs. Because a day of care is the unit million for drugs and biologicals) conditions such as depression, that defines the structure and compared to the proposed $26.2 million schizophrenia, and substance use scheduling of partial hospitalization (approximately $10 million for device disorders. Section 1861(ff)(1) of the Act services, we established a per diem categories and approximately $16.2 defines partial hospitalization services payment methodology for the PHP million for drugs and biologicals)), as the items and services described in APCs, effective for services furnished on which represents 0.04 percent of total paragraph (2) prescribed by a physician or after July 1, 2000 (65 FR 18452 projected OPPS payments for CY 2018 and provided under a program through 18455). Under this (approximately $70 billion). Therefore, described in paragraph (3) under the methodology, the median per diem costs we estimate that pass-through spending supervision of a physician pursuant to were used to calculate the relative in CY 2018 will not amount to 2.0 an individualized, written plan of treatment established and periodically payment weights for the PHP APCs. percent of total projected OPPS CY 2018 Section 1833(t)(9)(A) of the Act requires program spending. reviewed by a physician (in consultation with appropriate staff the Secretary to review, not less often VII. OPPS Payment for Hospital participating in such program), which than annually, and revise the groups, Outpatient Visits and Critical Care sets forth the physician’s diagnosis, the the relative payment weights, and the Services type, amount, frequency, and duration wage and other adjustments described in section 1833(t)(2) of the Act to take In the CY 2018 OPPS/ASC proposed of the items and services provided under the plan, and the goals for into account changes in medical rule (82 FR 33637), for CY 2018, we practice, changes in technology, the proposed to continue with our current treatment under the plan. Section 1861(ff)(2) of the Act describes the items addition of new services, new cost data, clinic and emergency department (ED) and other relevant information and hospital outpatient visits payment and services included in partial hospitalization services. Section factors. policies. For a description of the current We began efforts to strengthen the 1861(ff)(3)(A) of the Act specifies that a clinic and ED hospital outpatient visits PHP benefit through extensive data PHP is a program furnished by a policies, we refer readers to the CY 2016 analysis, along with policy and payment hospital to its outpatients or by a OPPS/ASC final rule with comment changes finalized in the CY 2008 OPPS/ community mental health center period (80 FR 70448). We also proposed ASC final rule with comment period (72 (CMHC), as a distinct and organized to continue with and not propose any FR 66670 through 66676). In that final intensive ambulatory treatment service, change to our payment policy for rule with comment period, we made offering less than 24-hour-daily care, in critical care services for CY 2018. For a two refinements to the methodology for description of the current payment a location other than an individual’s computing the PHP median: The first policy for critical care services, we refer home or inpatient or residential setting. remapped 10 revenue codes that are readers to the CY 2016 OPPS/ASC final Section 1861(ff)(3)(B) of the Act defines common among hospital-based PHP rule with comment period (80 FR a CMHC for purposes of this benefit. claims to the most appropriate cost 70449), and for the history of the Section 1833(t)(1)(B)(i) of the Act centers; and the second refined our payment policy for critical care services, provides the Secretary with the methodology for computing the PHP we refer readers to the CY 2014 OPPS/ authority to designate the OPD services median per diem cost by computing a ASC final rule with comment period (78 to be covered under the OPPS. The separate per diem cost for each day FR 75043). In the proposed rule, we Medicare regulations that implement rather than for each bill. sought public comments on any changes this provision specify, at 42 CFR 419.21, In CY 2009, we implemented several to these codes that we should consider that payments under the OPPS will be regulatory, policy, and payment for future rulemaking cycles. We made for partial hospitalization services changes, including a two-tier payment continued to encourage those parties furnished by CMHCs as well as approach for partial hospitalization who comment to provide the data and Medicare Part B services furnished to services under which we paid one analysis necessary to justify any hospital outpatients designated by the amount for days with 3 services under suggested changes. Secretary, which include partial PHP APC 0172 (Level 1 Partial
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Hospitalization) and a higher amount that we would review and analyze the a detailed discussion on this policy, we for days with 4 or more services under data during the CY 2012 rulemaking refer readers to the CY 2014 OPPS/ASC PHP APC 0173 (Level 2 Partial cycle and, based on these analyses, we final rule with comment period (78 FR Hospitalization) (73 FR 68688 through might further refine the payment 75047 through 75050). 68693). We also finalized our policy to mechanism. We refer readers to section In the CY 2015 OPPS/ASC final rule deny payment for any PHP claims X.B. of the CY 2011 OPPS/ASC final with comment period (79 FR 66902 submitted for days when fewer than 3 rule with comment period (75 FR 71991 through 66908), we continued to apply units of therapeutic services are through 71994) for a full discussion. our established policies to calculate the provided (73 FR 68694). Furthermore, In addition, in accordance with four PHP APC per diem payment rates for CY 2009, we revised the regulations section 1301(b) of the Health Care and based on PHP APC geometric mean per at 42 CFR 410.43 to codify existing basic Education Reconciliation Act of 2010 diem costs, using the most recent claims PHP patient eligibility criteria and to (HCERA 2010), we amended the and cost data for each provider type. add a reference to current physician description of a PHP in our regulations In the CY 2016 OPPS/ASC final rule certification requirements under 42 CFR to specify that a PHP must be a distinct with comment period (80 FR 70455 424.24 to conform our regulations to our and organized intensive ambulatory through 70465), we described our longstanding policy (73 FR 68694 treatment program offering less than 24- extensive analysis of the claims and cost through 68695). We also revised the hour daily care other than in an data and ratesetting methodology. We partial hospitalization benefit to include individual’s home or in an inpatient or found aberrant data from some hospital- several coding updates (73 FR 68695 residential setting. In accordance with based PHP providers that were not through 68697). section 1301(a) of HCERA 2010, we captured using the existing OPPS ±3 For CY 2010, we retained the two-tier revised the definition of a CMHC in the standard deviation trims for extreme payment approach for partial regulations to conform to the revised CCRs and excessive CMHC charges hospitalization services and used only definition now set forth under section resulting in CMHC geometric mean hospital-based PHP data in computing 1861(ff)(3)(B) of the Act (75 FR 71990). costs per day that were approximately For CY 2012, as discussed in the CY the PHP APC per diem costs, upon the same as or more than the daily 2012 OPPS/ASC final rule with which PHP APC per diem payment rates payment for inpatient psychiatric comment period (76 FR 74348 through are based. We used only hospital-based facility services. Consequently, we 74352), we determined the relative PHP data because we were concerned implemented a trim to remove hospital- payment weights for partial about further reducing both PHP APC based PHP service days that use a CCR per diem payment rates without hospitalization services provided by that was greater than 5 (CCR5) to knowing the impact of the policy and CMHCs based on data derived solely calculate costs for at least one of their payment changes we made in CY 2009. from CMHCs and the relative payment component services, and a trim on Because of the 2-year lag between data weights for partial hospitalization CMHCs with a geometric mean cost per collection and rulemaking, the changes services provided by hospital-based day that is above or below 2 (±2) we made in CY 2009 were reflected for PHPs based exclusively on hospital standard deviations from the mean. We the first time in the claims data that we data. stated in the CY 2016 OPPS/ASC final used to determine payment rates for the In the CY 2013 OPPS/ASC final rule rule with comment period (80 FR CY 2011 rulemaking (74 FR 60556 with comment period, we finalized our 70456) that, without using a trimming through 60559). proposal to base the relative payment In the CY 2011 OPPS/ASC final rule weights that underpin the OPPS APCs, process, the data from these providers with comment period (75 FR 71994), we including the four PHP APCs (APCs would inappropriately skew the established four separate PHP APC per 0172, 0173, 0175, and 0176), on geometric mean per diem cost for Level diem payment rates: Two for CMHCs geometric mean costs rather than on the 2 CMHC services. (APC 0172 (for Level 1 services) and median costs. We established these four In addition, in the CY 2016 OPPS/ APC 0173 (for Level 2 services)) and two PHP APC per diem payment rates based ASC final rule with comment period (80 for hospital-based PHPs (APC 0175 (for on geometric mean cost levels FR 70459 through 70460), we corrected Level 1 services) and 0176 (for Level 2 calculated using the most recent claims a cost inversion that occurred in the services)), based on each provider type’s and cost data for each provider type. For final rule data with respect to hospital- own unique data. For CY 2011, we also a detailed discussion on this policy, we based PHP providers. We corrected the instituted a 2-year transition period for refer readers to the CY 2013 OPPS/ASC cost inversion with an equitable CMHCs to the CMHC APC per diem final rule with comment period (77 FR adjustment to the actual geometric mean payment rates based solely on CMHC 68406 through 68412). per diem costs by increasing the Level data. Under the transition methodology, In the CY 2014 OPPS/ASC proposed 2 hospital-based PHP APC geometric CMHC APCs Level 1 and Level 2 per rule (78 FR 43621 through 43622), we mean per diem costs and decreasing the diem costs were calculated by taking 50 solicited comments on possible future Level 1 hospital-based PHP APC percent of the difference between the initiatives that may help to ensure the geometric mean per diem costs by the CY 2010 final hospital-based PHP long-term stability of PHPs and further same factor, to result in a percentage median costs and the CY 2011 final improve the accuracy of payment for difference equal to the average percent CMHC median costs and then adding PHP services, but proposed no changes. difference between the hospital-based that number to the CY 2011 final CMHC In the CY 2014 OPPS/ASC final rule Level 1 PHP APC and the Level 2 PHP median costs. A 2-year transition under with comment period (78 FR 75050 APC for partial hospitalization services this methodology moved us in the through 75053), we summarized the from CY 2013 through CY 2015. direction of our goal, which is to pay comments received on those possible Finally, we renumbered the PHP appropriately for partial hospitalization future initiatives. We also continued to APCs, which were previously 0172, services based on each provider type’s apply our established policies to 0173, 0175, and 0176, to 5851, 5852, data, while at the same time allowing calculate the four PHP APC per diem 5861, and 5862, respectively. For a providers time to adjust their business payment rates based on geometric mean detailed discussion of the PHP operations and protect access to care for per diem costs using the most recent ratesetting process, we refer readers to Medicare beneficiaries. We also stated claims data for each provider type. For the CY 2016 OPPS/ASC final rule with
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comment period (80 FR 70462 through 2. Development of the PHP APC by providers with extreme data. For this 70467). Geometric Mean Per Diem Costs CY 2018 OPPS/ASC final rule with In the CY 2017 OPPS/ASC final rule In the CY 2018 OPPS/ASC proposed comment period, we followed the same with comment period (81 FR 79687 rule (82 FR 33639), for CY 2018 and data preparation steps. Before any trims through 79691), we continued to apply subsequent years, we proposed to follow or exclusions, there were 50 CMHCs in the final PHP claims data file (compared our established policies to calculate the the PHP ratesetting methodology to 47 CMHCs in the CY 2018 OPPS/ASC PHP APC per diem payment rates based described in section VIII.B.2. of the CY proposed rule). Under the ±2 standard on geometric mean per diem costs using 2016 OPPS/ASC final rule with deviation trim policy, we excluded any comment period (80 FR 70462 through the most recent claims and cost data for data from a CMHC for ratesetting 70466) to determine the PHP APCs’ each provider type. However, we purposes when the CMHC’s geometric geometric mean per diem costs and to finalized a policy to combine the Level mean cost per day was more than ±2 calculate the payment rates for APCs 1 and Level 2 PHP APCs for CMHCs and standard deviations from the geometric 5853 and 5863, incorporating the to combine the Level 1 and Level 2 mean cost per day for all CMHCs. By modifications made in our CY 2017 APCs for hospital-based PHPs because applying this trim for CY 2018 OPPS/ASC final rule with comment we believed this would best reflect ratesetting, in this final rule with period. As discussed in section VIII.B.1. actual geometric mean per diem costs comment period, we excluded 3 CMHCs of the CY 2017 OPPS/ASC final rule going forward, provide more predictable with geometric mean per diem costs per per diem costs, particularly given the with comment period (81 FR 79680 day below the trim’s lower limit of small number of CMHCs, and generate through 79687), we finalized our $47.44 and 1 CMHC above the trim’s more appropriate payments for these proposal that, for CY 2017 and upper limit of $427.72 from the final services, for example by avoiding the subsequent years, the geometric mean ratesetting for CY 2018. This standard cost inversions for hospital-based PHPs per diem cost for hospital-based PHP deviation trim removed 4 providers addressed in the CY 2016 and CY 2017 APC 5863 would be based upon actual from ratesetting whose data would have OPPS/ASC final rules with comment hospital-based PHP claims and costs for skewed the calculated final geometric period (80 FR 70459 and 81 FR 79682). PHP service days providing 3 or more mean per diem cost. We implemented an 8-percent outlier services. Similarly, we finalized our In accordance with our PHP cap for CMHCs to mitigate potential proposal that, for CY 2017 and ratesetting methodology, in the outlier billing vulnerabilities by limiting subsequent years, the geometric mean proposed rule, we also removed service the impact of inflated CMHC charges on per diem cost for CMHC APC 5853 days with no wage index values because outlier payments. We will continue to would be based upon actual CMHC we use the wage index data to remove monitor the trends in outlier payments claims and costs for CMHC service days the effects of geographic variation in and consider policy adjustments as providing 3 or more services. costs prior to APC geometric mean per necessary. The CMHC or hospital-based PHP diem cost calculation (80 FR 70465). In APC per diem costs are the provider- this CY 2018 final rule ratesetting, no For a comprehensive description on type specific costs derived from the CMHCs were missing wage index data the background of the PHP payment most recent claims and cost data. The for all of their service days. Therefore, policy, we refer readers to the CY 2016 CMHC or hospital-based PHP APC per we did not exclude any CMHCs due to and CY 2017 OPPS/ASC final rules with diem payment rates are the national lack of wage index data. comment period (80 FR 70453 through unadjusted payment rates calculated In addition to our trims and data 70455 and 81 FR 79678 through 79680). from the CMHC or hospital-based PHP exclusions, before determining the PHP B. PHP APC Update for CY 2018 APC per diem costs, after applying the APC geometric mean per diem costs, we OPPS budget neutrality adjustments also assess CCRs (80 FR 70463). Our 1. PHP APC Geometric Mean Per Diem described in section II.A.4. of this final longstanding PHP OPPS ratesetting Costs rule with comment period. methodology defaults any CMHC CCR>1 We proposed to apply our established to the statewide hospital ancillary CCR For CY 2018, in the CY 2018 OPPS/ methodologies in developing the CY (80 FR 70457). In this CY 2018 final rule ASC proposed rule (82 FR 33639), we 2018 geometric mean per diem costs ratesetting, we identified one CMHC proposed to continue to apply our and payment rates, including the that had a CCR>1. This CMHC’s CCR established policies to calculate the PHP application of a ±2 standard deviation was 1.002, and it was defaulted to its APC per diem payment rates based on trim on costs per day for CMHCs and a appropriate statewide hospital ancillary geometric mean per diem costs using CCR≤5 hospital service day trim for CCR for CY 2018 ratesetting purposes. the most recent claims and cost data for hospital-based PHP providers. These In summary, these data preparation each provider type. Specifically, we two trims were finalized in the CY 2016 steps adjusted the CCR for 1 CMHC and proposed to continue to use CMHC APC OPPS/ASC final rule with comment excluded 4 CMHCs, resulting in the 5853 (Partial Hospitalization (3 or More period (80 FR 70455 through 70462) for inclusion of a total of 46 CMHCs in our Services Per Day)) and hospital-based CY 2016 and subsequent years. CY 2018 final rule ratesetting modeling PHP APC 5863 (Partial Hospitalization (compared to 39 CMHCs in our (3 or More Services Per Day)). We a. CMHC Data Preparation: Data Trims, proposed rule ratesetting modeling in proposed to continue to calculate the Exclusions, and CCR Adjustments the CY 2018 OPPS/ASC proposed rule). geometric mean per diem costs for CY For the CY 2018 proposed rule, prior The trims removed 864 CMHC claims 2018 for APC 5853 for CMHCs using to calculating the proposed geometric from the 16,242 total CMHC claims, only CY 2016 CMHC claims data and mean per diem cost for CMHC APC resulting in 15,378 CMHC claims used the most recent CMHC cost data, and 5853, we prepared the data by first in ratesetting. We believe that excluding the CY 2018 geometric mean per diem applying trims and data exclusions, and providers with extremely low or high costs for APC 5863 for hospital-based assessing CCRs as described in the CY geometric mean costs per day or PHPs using only CY 2016 hospital-based 2016 OPPS/ASC final rule with extremely low or high CCRs protects PHP claims data and the most recent comment period (80 FR 70463 through CMHCs from having that data hospital cost data. 70465), so that ratesetting is not skewed inappropriately skew the calculation of
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the CMHC APC geometric mean per data used for final rule ratesetting did the same for hospital-based PHPs. diem cost. Moreover, we believe that (compared to 393 hospital-based PHPs We cited several reasons for these trims, exclusions, and adjustments in the CY 2018 OPPS/ASC proposed implementing the single-tier payment help prevent inappropriate fluctuations rule). In addition, 2 hospital-based PHP system (81 FR 79682 through 79686) in the PHP APC geometric mean per providers were defaulted to using their and noted that one primary reason for diem payment rates. overall hospital ancillary CCR due to combining the two-tier system into a After applying all of the above trims, outlier cost center CCR values (72.7362 single tier, by provider type, was the exclusions, or adjustments, the final CY and 117.1943). After completing these decrease in the number of CMHCs (81 2018 geometric mean per diem cost for data preparation steps, we calculated FR 79683). With a small number of all CMHCs for providing 3 or more the final geometric mean per diem cost providers, data from large providers services per day (APC 5853) is $143.22 for hospital-based PHP APC 5863 for with a high percentage of all PHP (compared to the proposed geometric hospital-based PHP services. The final service days and unusually high or low mean per diem cost of $128.81). geometric mean per diem cost for geometric mean costs per day would b. Hospital-Based PHP Data Preparation: hospital-based PHP providers that have a more pronounced effect on the Data Trims and Exclusions provide 3 or more services per service PHP APCs geometric mean per diem day (hospital-based PHP APC 5863) is costs, skewing costs up or down. The For the CY 2018 proposed rule and for $208.09 (compared to $213.60 from the effect would be magnified by continuing this CY 2018 final rule with comment CY 2018 OPPS/ASC proposed rule). to split the geometric mean per diem period, we followed a data preparation We received a few public comments costs further by distinguishing between process for hospital-based PHP relating to our proposal to use our Level 1 and Level 2 PHP services. We providers that is similar to that used for established methodology and policies in believed that creating a single PHP APC CMHCs by applying trims and data developing the PHP geometric mean per for each provider type for providing 3 or exclusions as described in the CY 2016 diem costs. more PHP services per day would OPPS/ASC final rule with comment Comment: One commenter opposed reduce these cost fluctuations and period (80 FR 70463 through 70465) so CMS continuing to use the single-tier provide more stability in the PHP APC that our ratesetting is not skewed by payment system implemented in CY geometric mean per diem costs. providers with extreme data. Before any 2017 OPPS/ASC rulemaking because the We do not believe that the single-tier trimming or exclusions, there were 424 commenter believed this system payment system will lead to a reduction hospital-based PHP providers in the CY punished CMHCs for the cost inversion in the number of PHPs, but rather that 2016 final PHP claims data used in this in the hospital-based PHP data. The the increased stability in CMHC and CY 2018 OPPS/ASC final rule with commenter suggested that CMS return hospital-based PHP payment rates will comment period (compared to 420 to the two-tier payment system. Another provide more stability for the PHP hospital-based PHPs in the CY 2018 commenter was concerned that the APCs. In addition, the calculated rates OPPS/ASC proposed rule). single-tier payment system could have for APCs 5853 and 5863 continue to be For hospital-based PHP providers, we unintended consequences, including applied a trim on hospital service days reducing the number of PHPs or the based upon the actual costs of CMHCs when the CCR was greater than 5 at the number of services provided per day, and hospital-based PHPs, respectively. cost center level. The CCR>5 hospital and urged CMS to monitor the data. Therefore, we believe that the payment service day trim removed hospital-based One commenter disagreed with CMS rates for the single-tier PHP APCs PHP service days that use a CCR>5 to paying CMHCs and hospital-based PHPs should be an appropriate approximation calculate costs for at least one of their differently for providing the exact same of provider costs, and should not result component services. Unlike the ±2 services and believed that the APCs in reduced access to care. standard deviation trim, which distinguished by provider type hurts Because the single-tier PHP APCs excluded CMHC providers that failed rather than rewards CMHCs for being 5853 and 5863 became effective January the trim, the CCR>5 trim excluded any more cost effective than hospital-based 1, 2017, we will have to wait until our hospital-based PHP service day where PHPs. The commenter referred to a 2011 CY 2017 claims data are available to any of the services provided on that day bill introduced in the Congress to determine any effect of the payment were associated with a CCR>5. address the ‘‘inequity’’ of the current rates for these APCs on the provision of Applying this trim removed from our payment system and stated that CMHCs services per day. We will continue to final rule ratesetting service days from should be paid the same rate as monitor PHP data for any unintended 8 hospital-based PHP providers with hospital-based PHPs. This commenter consequences resulting from the single- CCRs ranging from 5.2024 to 17.5702. also stated that setting CMHCs’ payment tier APC policy. However, all of the service days for rates based on a small number of The OPPS pays for hospital outpatient these 8 hospital-based PHP providers CMHCs does not reflect the actual cost services, including partial had at least one service associated with of providing these services and hospitalization services. This system a CCR>5, so the trim removed these expressed concern that basing payments bases payment on the geometric mean providers entirely from our final rule at the mean or median level would per diem costs of providing services ratesetting. In addition, 16 hospital- result in half of CMHCs receiving using provider data from claims and based PHPs reported zero daily costs, payments less than their costs, which cost reports. We calculate the PHP APC and therefore were removed for having would guarantee that more CMHCs geometric mean per diem costs based on no days with PHP payment; 1 hospital- would close, further limiting access to the data provided for each type of based PHP was removed for missing care. provider to determine payment for these wage index data; and 1 hospital-based Response: We thank the commenters services. We believe that this system PHP was removed by the OPPS ±3 for their input. We reiterate our single- provides appropriate payment for standard deviation trim on costs per tier payment policy and rationale. In the partial hospitalization services based on day. CY 2017 OPPS/ASC final rule with actual provider costs. The final PHP Therefore, we excluded 26 hospital- comment period, we combined the APC geometric mean per diem costs for based PHP providers, resulting in 398 Level 1 and Level 2 PHP APCs into a CY 2018 reflect these actual provider hospital-based PHP providers in the single tier PHP APC for CMHCs, and we costs.
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Regarding the 2011 bill introduced in fluctuations in their payment rates due rates. The commenter noted that the Congress that would have required to aberrant data. declining payment rates are occurring at CMHCs and hospital-based PHPs to be Comment: One commenter suggested a time when CMHCs have experienced paid at the same rate, we note that this that CMS consider paying PHPs using a higher costs due to the establishment of bill was not enacted. quality-based payment system, and that CMHC conditions of participation The difference in payment between CMS use a value-based purchasing (CoPs) and higher bad debt expenses. CMHCs and hospital-based PHPs is program for PHPs. The commenter believed that CMS is based upon differences in resource use Response: Currently, there is no only concerned about protecting access (or costs). When Congress required the statutory language explicitly authorizing to hospital-based PHPs, and not to Secretary to implement an outpatient a value-based purchasing program for CMHCs PHPs. prospective payment system, it PHPs. We responded to a similar public Response: The final CY 2018 CMHC generally required that this payment comment in the CY 2016 OPPS/ASC geometric mean per diem costs are 11 system group clinically similar covered final rule with comment period (80 FR percent higher than the proposed services with respect to resource use 70462) and refer readers to a summary geometric mean per diem costs, and are (section 1833(t)(2) of the Act). Because of that comment and our response. To approximately 15 percent higher than the resource uses of CMHCs and reiterate, sections 1833(t)(2) and those costs finalized in the CY 2017 hospital-based PHPs are different, these 1833(t)(9) of the Act set forth the rulemaking. These final CY 2018 CMHC two provider types are paid under requirements for establishing and geometric mean per diem costs are different APCs, based on their actual adjusting OPPS payment rates, which based upon the most recent CMHC resource use. include PHP payment rates. Section claims and cost data reported by Because the cost of providing partial 1833(t)(17) of the Act authorizes the providers. Therefore, we believe the hospitalization services differs Hospital OQR Program, which applies a payment rate derived from these significantly by site of service, we payment reduction to subsection (d) geometric mean per diem costs established different PHP APC payment hospitals that fail to meet program represents an appropriate payment to rates for hospital-based PHPs and requirements. In the CY 2015 OPPS/ CMHCs and should not result in CMHCs in the CY 2011 OPPS/ASC final ASC proposed rule (79 FR 41040), we provider closures or affect beneficiary rule with comment period (75 FR 71991 considered future inclusion of, and access to care. through 71994). However, we allowed a requested comments on, the following Most (if not all) of the costs associated 2-year transition to the CMHC payment quality measures addressing PHP issues with adhering to CoPs should be rates based solely on CMHC data. With that would apply in the hospital captured in the cost report data used in respect to the continued use of PHP outpatient setting: (1) 30-day ratesetting and, therefore, are accounted APC geometric mean per diem costs for Readmissions; (2) Group Therapy; and for when computing the geometric mean determining payment rates by provider, (3) No Individual Therapy. We also refer per diem costs. The reduction to bad we refer readers to the CY 2013 OPPS/ readers to the CY 2015 OPPS/ASC final debt reimbursement was a result of ASC final rule with comment period (77 rule with comment period (79 FR 66957 provisions of section 3201 of the Middle FR 68406 through 68412) for a through 66959) for a detailed discussion Class Tax Extension and Job Creation discussion of the implementation of this of PHP measures considered for Act of 2012 (Pub. L. 112–96). The policy. The resulting payment rates inclusion in the Hospital OQR Program reduction to bad debt reimbursement reflect the geometric mean cost of what in future years. The Hospital OQR impacted all providers eligible to providers expend to maintain such Program does not apply to CMHCs. receive bad debt reimbursement, as programs, based on data provided by Comment: One commenter presented discussed in the CY 2013 End-Stage CMHCs and hospital-based PHPs, which a number of suggestions for a more Renal Disease final rule (77 FR 67518). we believe are an improvement over the holistic approach to the way Medicare Medicare currently reimburses bad debt payment rates under the two-tier (or Medicaid) pays for and covers PHP for eligible providers at 65 percent. methodology calculated based on services, including coverage for case We appreciate the commenter’s input median costs using only hospital-based management, and assistance with regarding the effect any reduction in data. medication compliance, proper housing, PHP payment rates would have on Comment: One commenter was and work and training facilities. access to care, but we disagree with the concerned that the PHP trim Response: We appreciate these commenter’s assertion that CMS is only methodologies could cause changes to suggestions. As we noted in the concerned about access to hospital- the payment rates which could lead to preceding comment response, the based PHPs. We are working to a reduction in the number of PHPs. The payment methodology for PHP services strengthen continued access to both commenter urged CMS to monitor the is governed by sections 1833(t)(2) and CMHCs and hospital-based PHPs for data to ensure that there are no 1833(t)(9) of the Act. PHP services are eligible Medicare beneficiaries. For unintended consequences, such as a defined in section 1861(ff) of the Act example, for the CY 2016 ratesetting, we reduction in the number of PHPs. and do not include those services conducted an extensive analysis of the Response: We thank the commenter described by the commenter. We do not ratesetting process, and discovered for sharing these concerns. We are have the authority to cover and pay for errors providers had made in claims continuing to monitor PHP data, services beyond those described in the coding of revenue and HCPCS codes including the number of PHPs that Act, or to pay outside of the statutory that were leading to lower geometric provide care to Medicare beneficiaries. methodology. mean per diem costs. In the CY 2016 Our trim methodologies should protect Comment: One commenter stated that OPPS/ASC final rule with comment PHP ratesetting from skewing by the CMHC PHP payment rate is too low, period (80 FR 70462 through 70466), we aberrant data, such as extremely low or which can affect access to care by some also included a detailed description of extremely high costs per day. We do not of the most disadvantaged Medicare the ratesetting process to help all PHPs believe that our PHP trim methodologies beneficiaries. This commenter record costs correctly so that we can will lead to a reduction in PHPs, but expressed concern about the closure of more fully capture PHP costs in rather that the trims we apply will CMHCs, which the commenter ratesetting. In that same final rule with provide stability to PHPs by reducing attributed to low CMHC PHP payment comment period, we also addressed
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fluctuations in payments and protected ratesetting showed only 50 CMHCs Day)). We calculated the geometric ratesetting from aberrant data by before we applied our data trims. We mean per diem costs for CY 2018 for implementing trims on all PHP data want to ensure that CMHCs remain a APC 5853 for CMHCs using only CY used in ratesetting (80 FR 70455 through viable option as providers of mental 2016 CMHC claims data and the most 70457). For example, the CMHC ±2 health care, and will continue to explore recent CMHC cost data, and the CY 2018 standard deviation trim has protected policy options for strengthening the geometric mean per diem costs for APC CMHCs by removing from ratesetting PHP benefit and increasing access to the 5863 for hospital-based PHPs using only those providers with aberrantly low valuable services provided by CMHCs CY 2016 hospital-based PHP claims data costs per day, which would have and hospital-based PHPs. and the most recent hospital cost data. lowered total CMHC geometric mean We did not receive any public We also are finalizing our proposal to per diem costs, and thus lowered CMHC comments on the hospital-based PHP continue applying our established trim per diem payment rates. In this CY 2018 geometric mean per diem costs. methodologies, including the final rule with comment period After consideration of the public application of a ±2 standard deviation ratesetting, that ±2 standard deviation comments we received, we are trim on costs per day for CMHCs and a trim resulted in our removing 4 CMHCs finalizing our proposals to apply our CCR>5 hospital service day trim for from the ratesetting data, 3 of which had established policies to calculate the PHP hospital-based PHP providers. costs per day that were extremely low. APC per diem payment rates based on The final CY 2018 PHP APC We agree that both CMHCs and geometric mean per diem costs using geometric mean per diem costs for hospital-based PHPs serve some of the the most recent claims and cost data for CMHC PHP APC 5853 are $143.22 and most disadvantaged Medicare each provider type. Specifically, we are for hospital-based PHP APC 5863 are beneficiaries, and appreciate the care finalizing our proposal to continue to $208.09, as shown in Table 74 below. that these providers give. We remain pay CMHCs using APC 5853 (Partial The final PHP APC payment rates are concerned about access to all PHP Hospitalization (3 or More Services Per included in Addendum A to this final services, and particularly about the Day)) and to continue to pay hospital- rule with comment period (which is small numbers of CMHCs. The CY 2016 based PHPs using APC 5863 (Partial available via the Internet on the CMS PHP data file of claims used for CY 2018 Hospitalization (3 or More Services Per Web site).
TABLE 74—CY 2018 PHP APC GEOMETRIC MEAN PER DIEM COSTS
Final PHP APC CY 2018 APC Group title geometric mean per diem costs
5853 Partial Hospitalization (3 or more services per day) for CMHCs ...... $143.22 5863 Partial Hospitalization (3 or more services per day) for hospital-based PHPs ...... 208.09
3. PHP Service Utilization Updates therapy on 8.5 percent of days with only implementation of APC 5853 and APC In the CY 2016 OPPS/ASC final rule 3 services provided and 5.0 percent of 5863 for providing 3 or more PHP with comment period (81 FR 79684 days with 4 or more services provided services per day, we are continuing to through 79685), we expressed concern (compared to 7.9 percent and 4.4 monitor utilization of days with only 3 over the low frequency of individual percent, respectively, in CY 2015 PHP services. therapy provided to beneficiaries. The claims). For this CY 2018 final rule with final CY 2016 claims data used for this In the CY 2018 OPPS/ASC proposed comment period, we used the final CY 2018 final rule with comment period rule (82 FR 33640), we stated that we update of the CY 2016 claims data. The revealed some increases in the provision are aware that our single-tier payment final CY 2016 claims data showed that of individual therapy compared to CY policy may influence a change in PHPs maintained an appropriately low 2015 claims data. In the CY 2016 final service provision because providers are utilization of 3 service days compared to claims data, hospital-based PHPs able to obtain payment that is heavily CY 2015. Hospital-based PHPs have provided individual therapy on 4.7 weighted to the cost of providing 4 or increased their provision of services percent of days with only 3 services and more services when they provide only 3 since CY 2015 by providing fewer days 5.8 percent of days with 4 or more services. We indicated that we are with 3 services only, and more days services (compared to 4.0 percent and interested in ensuring that providers with 5 or more services. CMHCs have 6.2 percent, respectively, in CY 2015). furnish an appropriate number of remained steady in providing an Similarly, in the CY 2016 final claims services to beneficiaries enrolled in appropriately low level of 3 service data, CMHCs provided individual PHPs. Therefore, with the CY 2017 days.
TABLE 75—PERCENTAGE OF PHP DAYS BY SERVICE UNIT FREQUENCY
CY 2015 CY 2016 * Change (%) (%) (%)
CMHCs: Percent of Days with 3 services ...... 4.7 4.8 2.1 Percent of Days with 4 services ...... 62.9 70.3 11.8 Percent of Days with 5 or more services ...... 32.4 24.9 ¥23.1 Hospital-based PHPs: Percent of Days with 3 services ...... 12.4 10.9 ¥12.1 Percent of Days with 4 services ...... 69.8 64.9 ¥7.0
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TABLE 75—PERCENTAGE OF PHP DAYS BY SERVICE UNIT FREQUENCY—Continued
CY 2015 CY 2016 * Change (%) (%) (%)
Percent of Days with 5 or more services ...... 17.8 24.1 35.4 * May not sum to 100 percent by provider type due to rounding.
As we noted in the CY 2017 OPPS/ strengthen and enhance the integrity of PHP services must be furnished in ASC final rule with comment period (81 the PHP benefit. We further stated that accordance with a physician FR 79685), we will continue to monitor because PHP is provided in lieu of certification and the beneficiary’s plan the provision of days with only 3 inpatient care, it should be a highly of care reflecting that need. services, particularly now that the structured and clinically intensive We analyzed CY 2015 and CY 2016 single-tier PHP APCs 5853 and 5863 are program. Our goal was to improve the PHP claims data to assess the intensity in place for providing 3 or more services level of service furnished in a day of of PHP services provided, using PHP- per day to CMHCs and hospital-based PHP, while also ensuring that the allowable HCPCS codes and provider PHPs, respectively. appropriate population utilizes the PHP and service date information. To It is important to reiterate our benefit (73 FR 68695). calculate the number of hours of PHP expectation that days with only 3 As discussed in the CY 2018 OPPS/ services provided to each beneficiary services are meant to be an exception ASC proposed rule (82 FR 33641 each day, we assumed each unit of and not the typical PHP day. In the CY through 33642), when we codified these service equaled 1 hour of time. Each 2009 OPPS/ASC final rule with eligibility criteria, we acknowledged service day was then mapped to its comment period, we clearly stated that commenters’ concerns related to the Sunday through Saturday calendar we consider the acceptable minimum eligibility requirement that a patient week, and the number of PHP hours per units of PHP services required in a PHP must require a minimum of 20 hours per week was calculated for each day to be 3 and explained that it was week of therapeutic services as beneficiary. Next, the service weeks for never our intention that 3 units of evidenced in their plan of care. For each beneficiary were sorted service represent the number of services example, we recognized commenters’ chronologically and assessed: The first to be provided in a typical PHP day. concerns that it may sometimes be service week in a continuous series of PHP is furnished in lieu of inpatient difficult for patients to receive 20 hours service weeks was flagged as an psychiatric hospitalization and is per week of therapeutic services, such ‘‘Admission’’ week, and the last service intended to be more intensive than a as when transitioning into or out of a week in a continuous series of service half-day program. We further indicated PHP program (73 FR 68695). Therefore, weeks was flagged as a ‘‘Discharge’’ that a typical PHP day should include to permit flexibility in treating PHP week. We removed from the analysis the 5 to 6 hours of services (73 FR 68687 patients, we require a minimum of 20 admission and discharge weeks for each through 68694). We explained that days hours per week of therapeutic services, beneficiary to permit us to assess the with only 3 units of services may be with the understanding that patients intensity of services provided to appropriate to bill in certain limited may not always meet this minimum, beneficiaries fully engaged in PHPs (that circumstances, such as when a patient and qualified the requirement by adding is, those in ‘‘nontransitional’’ weeks). might need to leave early for a medical ‘‘as evidenced in their plan of care.’’ We then calculated the total number of appointment and, therefore, would be This eligibility requirement only service weeks and the number of service unable to complete a full day of PHP treatment. At that time, we noted that if addresses the minimum amount of PHP weeks with at least 20 PHP hours for a PHP were to only provide days with services beneficiaries must require as each beneficiary. These two values were 3 services, it would be difficult for evidenced in their plan of care. It does then used to determine the percentage patients to meet the eligibility not address whether or not beneficiaries of nontransitional service weeks that requirement in 42 CFR 410.43, that receive a particular number of met the 20-hour PHP threshold for each patients must require a minimum of 20 therapeutic services per week. However, beneficiary. hours per week of therapeutic services we have noted in multiple prior OPPS/ As stated in the CY 2018 OPPS/ASC as evidenced in their plan of care (73 FR ASC final rules with comment period proposed rule (82 FR 33641), we found 68689). that a typical PHP day would include 5 that a majority of PHP patients did not to 6 hours per day of PHP services (70 receive at least 20 hours of PHP services 4. Minimum Service Requirement: 20 FR 68548, 71 FR 67999, 72 FR 66671, per week. Approximately half of Hours Per Week and 73 FR 68687). Medicare beneficiaries receiving PHP In the CY 2009 OPPS/ASC final rule Most recently, we discussed the 20 services received 20 hours or more of with comment period (73 FR 68694), we hours of services requirement in the CY services in 50 percent or more of codified patient eligibility criteria to 2017 rulemaking when we reminded nontransitional weeks. In CY 2016 reflect the intensive nature of a PHP. At providers that our regulations at claims data, only 16.4 percent of that time, we noted that many of the §§ 410.43(a)(3) and (c)(1) continue to Medicare beneficiaries in CMHCs and patient eligibility criteria had been require that PHP beneficiaries must 34.8 percent of Medicare beneficiaries longstanding policy requirements that require a minimum of 20 hours per in hospital-based PHPs received at least did not reflect a change in policy. The week of therapeutic services as 20 hours of PHP services in 100 percent added regulatory text was intended to evidenced in their plan of care, and that of nontransitional weeks.
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TABLE 76—NUMBER AND PERCENTAGE OF MEDICARE BENEFICIARIES RECEIVING AT LEAST 20 HOURS OF PHP SERVICES PER WEEK—CY 2015 THROUGH CY 2016
Beneficiaries Receiving 20 or more hours CY 2015 CY 2016 Type of PHP services per nontransitional week * Number Percentage Number Percentage
CMHC PHP Beneficiaries ...... In 50 percent or more of weeks ...... 1,205 53.1 1,016 57.3 In 100 percent of weeks ...... 319 14.1 291 16.4 Hospital-Based PHP Beneficiaries ...... In 50 percent or more of weeks ...... 8,610 51.0 8,333 56.7 In 100 percent of weeks ...... 5,003 29.6 5,115 34.8 * Weeks are trimmed to exclude admission and discharge weeks based on a Sunday through Saturday week. Nontransitional weeks are weeks that are not admission or discharge weeks.
Overall, the data suggest that some per week in programming, but the rule with comment period. One PHP beneficiaries may not be receiving patient and the treatment team commenter suggested that allowing the intensive services that eligible determined the amount of time in nurse practitioners to create the beneficiaries actually need. In the CY treatment. treatment plan, and supervise and direct 2018 OPPS/ASC proposed rule, we A few commenters suggested that patients in PHPs, would give providers stated that we were concerned about CMS forego editing, and instead more flexibility in providing services to these findings, and encouraged PHPs to implement a targeted medical review of meet the minimum requirements. review their admission practices and those providers whose data are One commenter was concerned that a ensure they are providing the services problematic. These and other 20-hour minimum service requirement, beneficiaries need. commenters suggested that CMS combined with limiting payment to Given similar concerns, in the CY educate the PHP provider community essentially a 3-service encounter, would 2017 OPPS/ASC final rule with about a 20-hour per week minimum not fully serve the patients and would comment period, we solicited public service requirement. A number of push patients out of PHPs and into comments on potential future editing of commenters suggested that CMS reissue ‘‘Intensive Outpatient Programs (IOPs).’’ PHP claims for the 20 hours per week the rescinded Special Edition 1607 One commenter stated that if there were minimum eligibility requirement and on MedLearn Matters article and its editing for a 20-hour requirement, the strengthening the tie between a associated Change Request 9880, about PHP revenue for one provider, for beneficiary’s receipt of 20 hours per messaging on the remittance advice to example, would decline by $100,000 at week of PHP services and payment for providers. One commenter suggested a time when the provider is struggling those services (81 FR 79686). We that CMS include beneficiaries in any to find nursing staff, and its psychiatry received a number of public comments communications about a 20-hour per and nursing costs are rising. in response to our solicitation, which week minimum service requirement. Multiple commenters described we addressed in the CY 2018 OPPS/ASC Several commenters believed that it reasons why PHP patients are proposed rule (82 FR 33641 through would be premature to edit claims until sometimes unable to attend the program 33642). CMS could determine the effect of the for 20 hours per week. Commenters In the CY 2018 OPPS/ASC proposed single-tier payment system on provision suggested exceptions for weather, acute rule, we solicited public comments on of services. These commenters urged a illness or comorbid disease, family or the advisability of applying a payment delay in editing until the CY 2019 childcare issues, holidays, requirement conditioned on a rulemaking when CMS could analyze transportation problems, other medical beneficiary’s receipt of a minimum of 20 the CY 2017 data (the first year that or social service appointments, court or hours of therapeutic services per week. could show the effect of the single-tier legal appointments, and local We also solicited public comments payment system on provision of emergencies or disasters. Several addressing the need for exceptions to services) and monitor utilization in the commenters discussed problems with such a policy. Specifically, we wanted meantime. A few commenters stated medication compliance and medication to know and understand the type of that CMS should not require weekly adjustments, the cognitive effects of occurrences or circumstances that billing of claims in order to implement which could make attending for 20 would cause a PHP patient to not payment editing of the 20-hour hours per week clinically suboptimal. receive at least 20 hours of PHP services requirement, as it would increase Several commenters noted that an per week, particularly where payment providers’ administrative burden overly strict edit could result in would still be appropriate. because it would increase the number of inappropriate changes and reduce Comment: Many commenters agreed claims providers would be required to access to PHP services. it is critical that beneficiaries requiring submit. Response: We thank the commenters PHP services receive the appropriate Some commenters cited language for their insights and suggestions. We intensity of services, but suggested that from the CY 2009 OPPS/ASC final rule will consider these comments in future CMS work with industry to define with comment period which rulemaking and in developing ‘‘intensity’’ more broadly than total implemented this eligibility subregulatory guidance. hours of services received per week. A requirement: That CMS stated it is to be We wish to correct two erroneous few commenters suggested that CMS documented in the plan of care and the assumptions included in the comments. check the Local Coverage language did not require PHP patients to First, we have not rescinded Change Determinations (LCDs) when evaluating receive 20 hours of care. One Request 9880 about messaging on the intensity. One commenter provided a commenter believed that an edit provider remittance advice. This Change history of the PHP benefit, and noted limiting payment would be unduly Request is available online at: https:// that, historically, day programs similar burdensome, particularly given the PHP www.cms.gov/Regulations-and- to PHPs were required to offer 20 hours preamble language in the CY 2009 final Guidance/Guidance/Transmittals/2017-
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Transmittals-Items/R1833OTN.html?DL per diem payments in outlier payments for providing a defined set of services Page=1&DLEntries=10&DLFilter=9880& (81 FR 79692 through 79695). This that are relatively low cost when DLSort=1&DLSortDir=ascending. outlier payment cap only affects compared to other OPPS services. As However, we did rescind MLN Special CMHCs, and does not affect other such, it is not necessary to also impose Edition (SE) article 1607, partly because provider types. This outlier payment a fixed dollar threshold on CMHCs. it referred to requiring weekly billing. cap is in addition to and separate from Therefore, we did not propose to set a We do not currently require PHPs to bill the current outlier policy and dollar threshold for CMHC outlier weekly, although PHPs may do so if reconciliation policy in effect. We payments. they wish. Second, regarding the finalized the CMHC outlier payment cap In summary, we proposed to continue comment about limiting payment to a 3- to be set at 8 percent of the CMHC’s to calculate our CMHC outlier threshold service encounter, it was unclear if the total per diem payments (81 FR 79694 and CMHC outlier payments according commenter believed that PHP per diem through 79695). to our established policies. payment was limited to that for 3 In the CY 2018 OPPS/ASC proposed We did not receive any public services. We note that the single-tier rule (82 FR 33642), we proposed to comments on these proposals. APCs for CMHCs and for hospital-based continue to designate a portion of the Therefore, we are finalizing our PHPs are based upon the geometric estimated 1.0 percent hospital proposals to continue to calculate mean per diem costs for providing 3 or outpatient outlier threshold specifically CMHC outlier threshold and CMHC more PHP services per day. PHP APCs for CMHCs, consistent with the outlier payments according to our 5853 and 5863 do not limit PHP services percentage of projected payments to established policies. Using the updated to 3 per day. CMHCs under the OPPS in CY 2018, data for this final rule with comment Our goal is for PHP providers to excluding outlier payments. This policy period, CMHCs are projected to receive continue to have flexibility in providing results in CMHC outliers being paid 0.03 percent of total hospital outpatient PHP services. However, we must ensure under limited circumstances associated payments in CY 2018, excluding outlier that Medicare beneficiaries enrolled in with costs from complex cases, rather payments. Therefore, for CY 2018 we PHPs are legitimately eligible for PHP than as a substitute for the standard PHP are designating approximately 0.02 services and receive appropriately payment to CMHCs. In the CY 2018 percent of the estimated 1.0 percent intensive treatment. As we seek to OPPS/ASC proposed rule, we also noted hospital outpatient outlier threshold for understand the usage of PHP services by that CMHCs are projected to receive CMHCs. Medicare beneficiaries, we also will 0.02 percent of total hospital outpatient IX. Procedures That Will Be Paid Only continue to monitor the intensity of payments in CY 2018, excluding outlier as Inpatient Procedures services provided on a weekly basis. payments. Therefore, we proposed to designate approximately 0.0027 percent A. Background C. Outlier Policy for CMHCs of the estimated 1.0 percent hospital We refer readers to the CY 2012 As discussed in the CY 2004 OPPS outpatient outlier threshold for CMHCs. OPPS/ASC final rule with comment final rule with comment period (68 FR As we do for each rulemaking cycle, we period (76 FR 74352 through 74353) for 63469 through 63470), after examining have updated the CMHC CCRs and a full historical discussion of our the costs, charges, and outlier payments claims data used to model the PHP longstanding policies on how we for CMHCs, we concluded that payments rates for this final rule with identify procedures that are typically establishing a separate OPPS outlier comment period. provided only in an inpatient setting policy for CMHCs would be appropriate. Based on our simulations of CMHC (referred to as the inpatient only (IPO) Beginning in CY 2004, we created a payments for CY 2018, in the proposed list) and, therefore, will not be paid by separate outlier policy specific to the rule, we proposed to continue to set the Medicare under the OPPS, and on the estimated costs and OPPS payments cutoff point for outlier payments for CY criteria that we use to review the IPO provided to CMHCs. We designated a 2018 at 3.4 times the highest CMHC list each year to determine whether or portion of the estimated OPPS outlier APC payment rate implemented for that not any procedures should be removed threshold specifically for CMHCs, calendar year, which for CY 2018 is the from the list. The complete list of codes consistent with the percentage of payment rate for CMHC APC 5853. In that will be paid by Medicare in CY projected payments to CMHCs under the addition, we proposed to continue to 2018 as inpatient only procedures is OPPS each year, excluding outlier apply the same outlier payment included as Addendum E to this final payments, and established a separate percentage that applies to hospitals. outlier threshold for CMHCs. Therefore, for CY 2018, we proposed to rule with comment period (which is The separate outlier threshold for continue to pay 50 percent of CMHC available via the Internet on the CMS CMHCs resulted in $1.8 million in APC geometric mean per diem costs Web site). outlier payments to CMHCs in CY 2004, over the cutoff point. For example, for B. Changes to the Inpatient Only (IPO) and $0.5 million in outlier payments to CY 2018, if a CMHC’s cost for partial List CMHCs in CY 2005. In contrast, in CY hospitalization services paid under 2003, more than $30 million was paid CMHC APC 5853 exceeds 3.4 times the 1. Methodology for Identifying to CMHCs in outlier payments. We note proposed payment rate for CMHC APC Appropriate Changes to IPO List that, in the CY 2009 OPPS/ASC final 5853, the outlier payment would be In the CY 2018 OPPS/ASC proposed rule with comment period, we also calculated as 50 percent of the amount rule (82 FR 33642 through 33645), for established an outlier reconciliation by which the cost exceeds 3.4 times the CY 2018, we proposed to use the same policy to address charging aberrations payment rate for CMHC APC 5853. methodology (described in the related to OPPS outlier payments (73 FR In section II.G. of the proposed rule, November 15, 2004 final rule with 68594 through 68599). In CY 2017, we for the hospital outpatient outlier comment period (69 FR 65834)) of implemented a CMHC outlier payment payment policy, we proposed to set a reviewing the current list of procedures cap to be applied at the provider level, fixed dollar threshold in addition to an on the IPO list to identify any such that in any given year, an APC multiplier threshold. APC 5853 is procedures that may be removed from individual CMHC will receive no more the only APC for which CMHCs may the list. We have established five criteria than a set percentage of its CMHC total receive payment under the OPPS, and is that are part of this methodology. As
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noted in the CY 2012 OPPS/ASC final Related Services) with status indicator Care Improvement (BPCI) and the rule with comment period (76 FR ‘‘J1’’. We stated in the proposed rule Comprehensive Care for Joint 74353), we utilize these criteria when that after consulting with stakeholders Replacement (CJR) initiatives, if the reviewing procedures to determine and our clinical advisors regarding the procedure was removed from the IPO whether or not they should be removed procedure described by CPT code list. from the IPO list and assigned to an 55866, we believe that this procedure Below is a summary of the public APC group for payment under the OPPS meets criteria 1 and 2. We sought comments we received in response to when provided in the hospital comment on whether the public the comment solicitation in the CY 2017 outpatient setting. We note that a believes that these criteria are met and OPPS/ASC proposed rule. These public procedure is not required to meet all of whether CPT code 55866 meets any comments were varied and nuanced. the established criteria to be removed other of the five criteria cited earlier. • A number of commenters believed from the IPO list. The criteria include Comment: Commenters, including that continued refinements to the TKA the following: cancer centers, physicians, and surgical procedure allowed it to be 1. Most outpatient departments are individual stakeholders, supported the performed safely on properly selected equipped to provide the services to the proposal to remove CPT code 55866 Medicare beneficiaries in the outpatient Medicare population. from the IPO list. These commenters setting. A number of facilities indicated 2. The simplest procedure described believed this procedure could be safely that they were currently performing by the code may be performed in most performed on hospital outpatients and TKA procedures on an outpatient basis outpatient departments. noted that many hospital outpatient in both the HOPD and ASC on non- 3. The procedure is related to codes departments are equipped to do so. Medicare patients. Commenters who that we have already removed from the Response: We appreciate the supported removing the TKA procedure IPO list. commenters’ support. from the IPO list also noted recent peer- 4. A determination is made that the Comment: One commenter opposed reviewed publications that reported on procedure is being performed in the removal of CPT code 55866 from the investigations of the feasibility of numerous hospitals on an outpatient IPO list, stating that the procedure outpatient TKA with positive results; basis. cannot be safely performed as an that is, TKA outpatients did not 5. A determination is made that the outpatient procedure for a majority of experience higher rates of complications procedure can be appropriately and patients. or readmissions in comparison to TKA safely performed in an ASC, and is on Response: We continue to believe that inpatients. the list of approved ASC procedures or the procedure described by CPT code • A minority of commenters has been proposed by us for addition to 55866 can be safely performed in the (including teaching hospital the ASC list. hospital outpatient setting on patients stakeholders and some professional Using the above-listed criteria, in the who are appropriate candidates to organizations representing orthopedic CY 2018 OPPS/ASC proposed rule (82 receive the procedure in that setting. surgeons) stated that the risk of FR 33643 and 33644), we identified the Because the procedure meets several of postsurgical complications was too high procedures described by the following the criteria for removal from the IPO for patients with the TKA procedure codes that we proposed to remove from list, we believe it is appropriate to performed in the outpatient setting for the IPO list for CY 2018: CPT code remove it. the Medicare population and noted that patients appropriate for the TKA 27447 (Arthroplasty, knee, condyle and 3. Removal of the Total Knee procedure performed on an outpatient plateau; medical and lateral Arthroplasty (TKA) Procedure basis tend to be younger, more active, compartments with or without patella Described by CPT Code 27447 resurfacing (total knee arthroplasty)) have fewer complications, and have and CPT code 55866 (Laparoscopy, For a number of years, total knee more at home support than most surgical prostatectomy, retropubic arthroplasty (TKA) has been a topic of Medicare beneficiaries. These radical, including nerve sparing, discussion for removal from the IPO list commenters also believed there was includes robotic assistance, when with both stakeholder support and insufficient research on the TKA performed). The procedures that we opposition. Most recently, in the CY procedure performed on an outpatient proposed to remove from the IPO list for 2017 OPPS/ASC proposed rule (81 FR basis to definitively claim that the CY 2018 and subsequent years, 45679 through 45681), we sought public procedure could be safely performed in including the HCPCS code, long comments on the removal of the TKA the outpatient setting. descriptors, and the CY 2018 payment procedure from the IPO list from • Some commenters noted that if the indicators, were displayed in Table 29 interested parties, including TKA procedure was removed from the of the proposed rule. specifically: Medicare beneficiaries and IPO list, inpatient TKA cases should not We note that we address the public advocate associations for Medicare be subject to Recovery Audit Contractor comments we received on removing the beneficiaries; orthopedic surgeons and (RAC) review for appropriate site-of- procedure described by CPT code 55866 physician specialty societies that service. In addition, some commenters from the IPO list under section IX.B.2. represent orthopedic surgeons who expressed concerns about the effect that of this final rule with comment period. perform TKA procedures; hospitals and removing the TKA procedure from the We address the public comments we hospital trade associations; and any IPO list could have on the BPCI and CJR received on removing CPT code 27447 other interested stakeholders. In the CY Medicare payment models. We stated in from the IPO list under section IX.B.3. 2017 proposed rule comment the CY 2017 OPPS/ASC final rule with of this final rule with comment period. solicitation, we requested stakeholder comment period (81 FR 79699) that we input on whether the TKA procedure would consider all public comments 2. Removal of Procedure Described by met the established criteria used to received in future policymaking. CPT Code 55866 identify procedures to remove from the In the CY 2018 OPPS/ASC proposed In the CY 2018 OPPS/ASC proposed IPO list. We also requested input rule (82 FR 33643), we stated that we rule, we proposed to remove CPT code regarding how to modify current have reviewed the clinical 55866 from the IPO list and to assign it Medicare payment models that include characteristics of the TKA procedure to C–APC 5362 (Level 2 Laparoscopy & TKA, such as the Bundled Payments for and related evidence, including current
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length-of-stay (LOS) data for inpatient successful candidates for outpatient outpatient TKA and possess specialized TKA procedures and peer-reviewed TKA. Several commenters referenced clinical knowledge and experience are literature related to outpatient TKA their personal, positive experiences most suited to create such guidelines. procedures. We also stated that we have with outpatient TKA. Other commenters Therefore, we do not expect to create or considered input from the comment supported the proposal, but with certain endorse specific guidelines or content solicitation in the CY 2017 OPPS/ASC caveats regarding patient safety, for the establishment of providers’ proposed rule (as summarized earlier) including requests that CMS develop, patient selection protocols. However, and the professional opinions of with input from stakeholders, patient we remind commenters that the ‘‘2- orthopedic surgeons and CMS clinical selection criteria and risk stratification midnight’’ rule continues to be in effect advisors. In addition, we stated that we protocols for TKA to be performed in an and was established to provide guidance have taken into account the outpatient setting. Two orthopedic on when an inpatient admission would recommendation from the summer 2016 specialty societies stated that their be appropriate for payment under meeting of the HOP Panel to remove the organization was in the process of Medicare Part A (inpatient hospital TKA procedure from the IPO list. Based developing these patient selection and services). In general, this guidance on this information, we stated in the CY protocol tools. provides that if the physician expects 2018 OPPS/ASC proposed rule that we In addition, some commenters the beneficiary to require hospital care have determined that the TKA requested that CMS explicitly state that that spans at least 2 midnights and procedure would be an appropriate the surgeon is the final arbiter of the admits the beneficiary based upon that candidate for removal from the IPO list. appropriate site for the surgical expectation, the case is appropriate for We stated that we expect providers to procedure, that CMS provide an payment under the IPPS (80 FR 70539). carefully develop evidence-based incentive for outpatient and ambulatory For stays for which the physician patient selection criteria to identify settings performing TKA, PHA, and expects the patient to need less than 2 patients who are appropriate candidates THA to be a part of a registry such as midnights of hospital care, an inpatient for an outpatient TKA procedure as well the American Joint Replacement admission is payable under Medicare as exclusionary criteria that would Registry, and that CMS confirm that Part A on a case-by-case basis if the disqualify a patient from receiving an surgeons will continue to have the documentation in the medical record outpatient TKA procedure. We believe option to select the appropriate setting supports the admitting physician’s that the subset of Medicare beneficiaries (inpatient or outpatient) for the determination that the patient requires who meet patient selection criteria for procedure. inpatient hospital care. This performance of the TKA procedure on Some commenters expressed concerns documentation and the physician’s an outpatient basis may have the that removal of TKA from the IPO list admission decision are subject to procedure performed safely in the may lead commercial payers to medical review, which is discussed in outpatient setting. implement coverage policies that would greater detail below (80 FR 70541). The In the CY 2018 OPPS/ASC proposed drive these surgeries from the inpatient 2-midnight rule does not apply to rule, we stated that we believe that the setting to lower cost outpatient settings procedures on the IPO list; that is, TKA procedure described by CPT code that may not be sufficiently prepared to medically necessary procedures that are 27447 meets a number of criteria for handle the complexities or risks on the IPO list are appropriate for removal from the IPO list, including associated with some outpatient TKA Medicare Part A payment without criteria 1, 2, and 4. We sought procedures. Further, some commenters regard to the actual or expected length comments on whether the public stated that removing TKA from the IPO of stay (80 FR 70539). believes that these criteria are met and list could drive TKA to specific facilities With regard to the behavior of whether the TKA procedure meets any based on cost alone, which could result commercial insurance providers and other of the five criteria stated in the in significant further stresses in isolated site selection for outpatient TKA, while beginning of this section. In the rural care settings. we believe that these comments are out proposed rule, we also proposed that Response: We appreciate the of the scope of the proposed rule, we CPT code 27447 would be assigned to commenters’ support of our proposal. note that commercial providers are C–APC 5115 (Level 5 Musculoskeletal As previously stated in the discussion of responsible for establishing their own Procedures) with status indicator ‘‘J1’’. the CY 2018 OPPS/ASC proposed rule, rules governing payment for services. Comment: Numerous commenters, we continue to believe that the decision Comment: Several commenters including individual stakeholders, regarding the most appropriate care opposed the proposal to remove the orthopedic surgeons, clinical specialty setting for a given surgical procedure is TKA procedure from the IPO list, societies, national and State-level a complex medical judgment made by including national and State-level hospital associations, hospital systems, the physician based on the beneficiary’s hospital associations, hospital systems, device manufacturers, and private individual clinical needs and and individual stakeholders. Some of insurance providers responded to this preferences and on the general coverage these commenters expressed concerns proposal. Some commenters, including rules requiring that any procedure be that TKA was not clinically appropriate some orthopedic specialty societies and reasonable and necessary. We also for the outpatient setting. The surgeons, private insurance providers, reiterate our previous statement that the commenters stated that the TKA ambulatory surgical centers, hospital removal of any procedure from the IPO procedure is invasive and Medicare systems, and beneficiaries supported the list does not require the procedure to be beneficiaries are more likely to have proposal to remove CPT code 27447 performed only on an outpatient basis. comorbidities that could make pain from the IPO list. Many of these While we continue to expect more difficult to control. The commenters believed that TKA met providers who perform outpatient TKA commenters also stated that, because of CMS’ established criteria for removing a on Medicare beneficiaries to use these comorbidities, Medicare procedure from the IPO list and stated comprehensive patient selection criteria beneficiaries will face greater that appropriately selected patients who to identify appropriate candidates for complications, recovery times, and were in excellent health and with no or the procedure, we believe that the rehabilitation needs than non-Medicare limited medical comorbidities and surgeons, clinical staff, and medical populations to recover from TKA sufficient caregiver support could be specialty societies who perform procedures.
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Response: We continue to believe that Response: We reiterate that removal of episode payment of the remaining the TKA procedure meets a number of the TKA procedure from the IPO list inpatient TKA BPCI and CJR episodes our established criteria for removal from does not require the procedure to be when compared to current payment the IPO list, including criteria 1, 2, and performed only on an outpatient basis. levels and affect a hospital’s ability to 4. We also continue to believe that there Removal of the TKA procedure from the fall below the established target price are a subset of Medicare beneficiaries IPO list allows for payment of the for the episode, thereby hindering the with less medical complexity who are procedure in either the inpatient setting hospital’s ability to generate savings able to receive this procedure safely on or the outpatient setting. The under the BPCI or CJR model. The a hospital outpatient basis and that commenter is correct that a prior commenters presented several proposed providers should adopt evidence-based inpatient hospital stay of at least 3 refinements to the BPCI and CJR models patient selection protocols to consecutive days is required by law to mitigate these effects, including appropriately identify these patients. As under Medicare FFS as a prerequisite adjusting the target price for BPCI and previously noted, removal of a for SNF coverage. We note that CJR episodes involving TKA to exclude procedure from the IPO list does not Medicare Advantage plans may elect, procedures that could have been require the procedure to be performed pursuant to 42 CFR 409.30 and performed in the HOPD or allowing only on an outpatient basis. Rather, it 422.101(c), to provide SNF coverage BPCI Model 2 and CJR episodes to be allows payment to be made under the without imposing the SNF 3-day initiated by TKA performed in the OPPS when the procedure is performed qualifying stay requirement and that hospital outpatient department. on a hospital outpatient. In addition, we CMS has issued conditional waivers of Response: As mentioned earlier, we expect that physicians will continue to the 3-day qualifying stay requirement as believe that there is a subset of less exercise their complex medical necessary to carry out the Medicare medically complex TKA cases that judgment, based on a number of factors, Shared Savings Program and to test could be appropriately and safely including the patient’s comorbidities, certain Innovation Center payment performed on an outpatient basis. the expected length of stay in the models, including the Next Generation However, we do not expect a significant hospital (in accordance with the 2- ACO Model. volume of TKA cases currently being midnight rule), the patient’s anticipated We agree that the physician should performed in the hospital inpatient need for postoperative skilled nursing take the beneficiaries’ need for post- setting to shift to the hospital outpatient care, and other factors. surgical services into account when setting as a result of removing this selecting the site of care to perform the procedure from the IPO list. At this Comment: Several commenters stated surgery. We would expect that Medicare time, we expect that a significant their concerns regarding the ability of beneficiaries who are selected for number of Medicare beneficiaries will beneficiaries to access postacute care for outpatient TKA would be less medically continue to receive treatment as an a TKA procedure at an SNF. By statute, complex cases with few comorbidities inpatient for TKA procedures. As beneficiaries must have a prior inpatient and would not be expected to require providers’ knowledge and experience in hospital stay of no fewer than 3 SNF care following surgery. Instead, we the delivery of hospital outpatient TKA consecutive days to be eligible for expect that many of these beneficiaries treatment develops, there may be a Medicare coverage of inpatient SNF would be appropriate for discharge to greater migration of cases to the hospital care. The commenters stated that home (with outpatient therapy) or home outpatient setting. However, we do not discharging outpatient TKA patients health care. We believe that expect a significant shift in TKA cases without a 3-day stay and access to comprehensive patient selection from the hospital inpatient setting to the adequate rehabilitation would increase protocols should be implemented to hospital outpatient setting between the likelihood of further medical properly identify these beneficiaries. January 1, 2018 (the effective date for concerns that may result in However, we do not believe that the removal of TKA from the IPO list) readmissions, which will result in Medicare should establish such and the current end dates of the higher expenses for the beneficiary, the protocols and believe that physicians performance periods for the BPCI and Medicare program, and the hospital. and providers should select an CJR models, September 30, 2018 and These commenters stated that if there is appropriate patient selection protocol. December 31, 2020, respectively. no commensurate waiver of the SNF 3- Comment: Numerous commenters Accordingly, we do not expect a day stay requirement, all outpatient from stakeholders addressed the effect substantial impact on the patient-mix TKA patients would need to be that removing TKA from the IPO list for the BPCI and CJR models. We intend appropriate for discharge to home or could potentially have on two Medicare to monitor the overall volume and home health care. One commenter payment models currently being complexity of TKA cases performed in questioned beneficiaries’ ability to administered by the Center for Medicare the hospital outpatient department to access the SNF benefit if a beneficiary and Medicaid Innovation: BPCI and the determine whether any future has outpatient TKA surgery and is then CJR model. The commenters were refinements to these models are admitted as an inpatient after being concerned that the proposal to remove warranted. discharged from the hospital outpatient TKA from the IPO list could Comment: Some commenters asked department. Other commenters noted significantly alter the composition of CMS to reconsider the proposed that the vast majority of beneficiaries BPCI and CJR participant hospitals’ assignment of CPT code 27447 to C– who fit the criteria for an outpatient patient populations. Specifically, the APC 5115 (Level 5 Musculoskeletal TKA or THA procedure would not need commenters believed that younger and Procedures) with status indicator ‘‘J1’’. institutional postacute care services. healthier patients would be more likely The commenters presented an analysis Commenters also stated that a large to receive outpatient TKAs and that a of OPPS claims data which indicated percentage of TKA inpatients do not higher proportion of patients receiving that approximately one-third of the TKA require a 3-day length of stay, and that inpatient TKAs would be high risk and/ claims reported no joint implant HCPCS removing TKAs from the IPO list would or more likely to require additional C-code on the claim. Some of these not preclude these patients from postacute care support. As a result, the commenters asserted that the claims meeting the 3-day qualifying stay commenters believed that a change in that did not include a joint implant had requirement when warranted. patient-mix could increase the average a geometric mean cost of approximately
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$3,808 and the claims that did include finalizing our proposal to remove the Response: We continue to believe that a joint implant had a geometric mean TKA procedure described by CPT code a 2-year prohibition on RAC review for cost of approximately $13,843, while 27447 from the IPO list beginning in CY TKA procedures performed in the the overall geometric mean cost for 2018 and to assign the TKA procedure inpatient setting is an adequate amount claims with CPT code 27447 was to C–APC 5115 with status indicator of time to allow providers to gain approximately $8,602. The commenters ‘‘J1’’. experience with determining the most requested that CMS only use claims for appropriate setting to perform these 4. Recovery Audit Contractor (RAC) ratesetting for CPT 27447 that include a procedures and establishing patient Review of TKA Procedures joint implant and to assign the selection criteria to assist in the procedure to APC 5116 (Level 6 In the CY 2018 OPPS/ASC proposed determination. As stated in the CY 2016 Musculoskeletal Procedures). One rule (82 FR 33643 and 33644), we OPPS/ASC final rule with comment commenter also stated that CMS failed proposed that if we finalized our period (80 FR 70538 through 70549), to provide the general public with an proposal to remove the TKA procedure under the 2-midnight rule, an inpatient explanation of the source of the described by CPT code 27447 from the admission is generally appropriate for geometric mean cost of the TKA IPO list, we would also prohibit RAC Medicare Part A payment if the procedure, which was CMS’ basis for review of patient status for TKA physician (or other qualified assigning the TKA procedure to a C– procedures performed in the inpatient practitioner) admits the patient as an APC. setting for a period of 2 years to allow inpatient based upon the expectation Response: Since the assignment of providers time to gain experience with that the patient will need hospital care CPT code 27447 to the IPO list, no these procedures in the outpatient that crosses at least 2 midnights. payment for claim lines billing this setting. We believe this approach will However, Medicare Part A payment is procedure code were made. Based on help ensure that hospitals can allowed on a case-by-case basis for clinical similarity with other determine whether to perform the inpatient admissions that do not satisfy musculoskeletal procedures, we procedure on a hospital outpatient or the 2-midnight benchmark, if the continue to believe that C–APC 5115 is hospital inpatient basis without taking documentation in the medical record an appropriate APC assignment for CPT into account the possibility of an supports the admitting physician’s code 27447. Further, we note that the inpatient TKA claim being denied upon determination that the patient requires 50th percentile IPPS payment for TKA a patient status review by a RAC. That inpatient hospital care despite an without major complications or is, given that this surgical procedure is expected length of stay that is less than comorbidities (MS–DRG 470) is roughly newly eligible for payment under either 2 midnights. The initial medical reviews $11,760 for FY 2018. We note that the the IPPS or the OPPS, we proposed that of claims for short-stay inpatient geometric mean cost for C–APC 5116 is RAC patient status reviews of a hospital admissions are conducted by QIOs, over $15,000. As previously stated, we claim is prohibited for a period of 2 which may refer providers to the RACs would expect that beneficiaries selected years. We note that RAC reviews of TKA due to exhibiting persistent for outpatient TKA would generally be procedures described by CPT code noncompliance with Medicare payment expected to be less complex and to not 27447 will continue to be permitted for policies, including, but not limited to: have major complications or issues other than patient status as an Having high denial rates and comorbidities. Therefore, we do not inpatient or outpatient, including those consistently failing to adhere to the 2- believe that it would be appropriate for for underlying medical necessity. midnight rule, or failing to improve the OPPS payment rate to exceed the their performance after QIO educational IPPS payment rate for TKA without Comment: Many commenters intervention. The 2-midnight rule and major complications/comorbidities supported a prohibition on RAC review this medical review policy do not apply because IPPS cases would generally be for patient status for TKA procedures to procedures that are included on the expected to be more complicated and performed in the inpatient setting for a IPO list. However, these policies do complex than those selected for period of 2 years. Some commenters apply to other inpatient admissions for performance in the hospital outpatient suggested that CMS prohibit RAC procedures that are not included on the setting and because inpatient cases review for a period of at least 36 months IPO list and would also generally apply would include room and board as well to allow consensus to develop around to TKA procedures performed in the as more time in the hospital. appropriate evidence-based patient With respect to the billing concern, selection criteria. One commenter hospital inpatient setting. As mentioned we rely on hospitals to bill all HCPCS requested that CMS impose a permanent previously, however, RAC patient status codes accurately in accordance with moratorium on RAC reviews of patient reviews for TKA procedures performed their code descriptors and CPT and status for TKA or confirm that after any in the hospital inpatient setting is CMS instructions, as applicable, and to moratorium is lifted, a RAC will only be prohibited for a period of 2 years. report charges on claims and charges permitted to undertake such a review 5. Public Requests for Additions to or and costs on their Medicare hospital upon a referral by a Quality Removal of Procedures on the IPO List cost reports appropriately (77 FR Improvement Organization (‘‘QIO’’). 68324). As we do every year, we will One commenter also requested that Commenters who responded to the review and evaluate the APC groupings CMS also clarify that its current 2- CY 2018 OPPS/ASC proposed rule also based on the latest available data in the midnight policy will apply to the TKA requested that CMS remove several next rulemaking cycle. procedure if it were to be removed from additional procedures from the IPO list. After consideration of the public the IPO, as it does for other inpatient These additional procedures are listed comments we received, we are admissions. in Table 77 below.
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TABLE 77—PROCEDURES REQUSTED BY COMMENTERS TO BE REMOVED FROM THE CY 2018 INPATIENT ONLY LIST
CY 2018 PT code CY 2018 long descriptor
23470 ...... Arthroplasty, glenohumeral joint; hemiarthroplasty. 23472 ...... Arthroplasty, glenohumeral joint; total shoulder (glenoid and proximal humeral replacement (eg, total shoulder)). 27125 ...... Hemiarthroplasty, hip, partial (eg, femoral stem prosthesis, bipolar arthroplasty). 27130 ...... Arthroplasty, acetabular and proximal femoral prosthetic replacement (total hip arthroplasty), with or without autograft or allograft. 27702 ...... Arthroplasty, ankle; with implant (total ankle). 27703 ...... Arthroplasty, ankle; revision, total ankle. 43282 ...... Laparoscopy, surgical, repair of paraesophageal hernia with implantation of mesh. 43772 ...... Laparoscopy, surgical, gastric restrictive procedure; removal of adjustable gastric restrictive device component only. 43773 ...... Laparoscopy, surgical, gastric restrictive procedure; removal and replacement of adjustable gastric restrictive device compo- nent only. 43774 ...... Laparoscopy, surgical, gastric restrictive procedure; removal of adjustable gastric restrictive device and subcutaneous port components.
After evaluating the above list of these requests into consideration and treat acute myocardial infarction codes that commenters requested to be any proposed policy changes regarding patients. removed from the IPO list against our these procedures will be announced in We evaluated the procedure described established criteria, we believe that CPT future rulemaking. A further discussion by CPT code 92941 against our criteria, codes 43282, 43772, 43773, 43774 meet of the comment solicitation of the and we agree with the commenter that several criteria to be removed from the possible removal of partial hip CPT code 92941 should be added to the IPO list, including criteria 3. arthroplasty (PHA) and total hip IPO list. Accordingly, we are removing these four arthroplasty (THA) procedures from the CPT codes from the IPO list for CY 2018 IPO list is included under section IX.C. 6. Summary of Changes to the IPO List and assigning them to APCs in this final of this final rule with comment period. for CY 218 rule with comment period. For the remaining CPT codes One commenter requested that CMS After consideration of the public requested to be removed from the IPO add the procedure described by CPT comments we received and for the list that describe joint replacement code 92941 (Percutaneous transluminal reasons discuss previously, we are procedures, because of the strong public revascularization of acute total/subtotal removing the following procedures from interest and numerous comments that occlusion during acute myocardial the IPO list for CY 2018: CPT codes we have received from stakeholders infarction, coronary artery or coronary 27447, 43282, 43772, 43773, 43774, and regarding our proposals to remove other artery bypass graft, any combination of 55866. We also are adding CPT code joint replacement procedures, namely intracoronary stent, artherectomy and 92941 to the IPO list for CY 2018. The the TKA procedure, from the IPO list, angioplasty, including aspiration specific procedures, including the CPT we are not removing these procedures thrombectomy when performed, single code, long descriptors, and the CY 2018 from the IPO list at this time to allow vessel) to the IPO list because this status indicators, are displayed in Table for further discussion. We will take procedure is performed emergently to 78 below.
TABLE 78—CHANGES TO THE INPATIENT ONLY LIST FOR CY 2018
CY 2018 CY 2018 CY 2018 CY 2018 long descriptor Status OPPS APC OPPS status CPT code assignment indicator
27447 ...... Arthroplasty, knee, condyle and plateau; medical and lateral compart- Removed ...... 5115 J1 ments with or without patella resurfacing (total knee arthroplasty). 43282 ...... Laparoscopy, surgical, repair of paraesophageal hernia with implantation Removed ...... 5362 J1 of mesh. 43772 ...... Laparoscopy, surgical, gastric restrictive procedure; removal of adjust- Removed ...... 5303 J1 able gastric restrictive device component only. 43773 ...... Laparoscopy, surgical, gastric restrictive procedure; removal and re- Removed ...... 5361 J1 placement of adjustable gastric restrictive device component only. 43774 ...... Laparoscopy, surgical, gastric restrictive procedure; removal of adjust- Removed ...... 5303 J1 able gastric restrictive device and subcutaneous port components. 55866 ...... Laparoscopy, surgical prostatectomy, retropubic radical, including nerve Removed ...... 5362 J1 sparing, includes robotic assistance, when performed. 92941 ...... Percutaneous transluminal revascularization of acute total/subtotal oc- Added ...... N/A C clusion during acute myocardial infarction, coronary artery or coronary artery bypass graft, any combination of intracoronary stent, artherectomy and angioplasty, including aspiration thrombectomy when performed, single vessel.
The complete list of codes (the IPO included as Addendum E to this final available via the Internet on the CMS list) that will be paid by Medicare in CY rule with comment period (which is Web site). 2018 as inpatient only procedures is
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C. Discussion of Solicitation of Public patient well-being, improved efficiency, including the at-home preoperative and Comments on the Possible Removal of and cost savings to the Medicare postoperative environment, anesthesia, Partial Hip Arthroplasty (PHA) and program, including shorter hospital pain management, and rehabilitation to Total Hip Arthroplasty (THA) stays resulting in fewer medical maximize rapid recovery, ambulation, Procedures From the IPO List complications, improved results, and and performance of activities of daily enhanced patient satisfaction. living. 1. Background As discussed in the CY 2018 OPPS/ We also noted in the proposed rule Partial hip arthroplasty (PHA), CPT ASC proposed rule (82 FR 33644 and that not uncommonly we receive code 27125 (Hemiarthroplasty, hip, 33645), recent innovations have enabled questions from the public about the IPO partial (eg, femoral stem prosthesis, surgeons to perform the PHA and THA list that lead us to believe that some bipolar arthroplasty)), and total hip procedures on an outpatient basis on members of the public may arthroplasty (THA) or total hip non-Medicare patients (both in the misunderstand certain aspects of the replacement, CPT code 27130 HOPD and in the ASC). These IPO list. Therefore, two important (Arthroplasty, acetabular and proximal innovations in PHA and THA care principles of the IPO list must be femoral prosthetic replacement (total include minimally invasive techniques, reiterated at the outset of this hip arthroplasty), with or without improved perioperative anesthesia, discussion. First, just because a autograft or allograft), have traditionally alternative postoperative pain procedure is not on the IPO list does not been considered inpatient surgical management, and expedited mean that the procedure cannot be procedures. The procedures were placed rehabilitation protocols. Patients performed on an inpatient basis. IPO list on the original IPO list in the CY 2001 undergoing minimally invasive surgical procedures must be performed on an OPPS final rule (65 FR 18780). In 2000, procedures instead of open surgical inpatient basis (regardless of the the primary factors that were used to techniques generally benefit from a expected length of the hospital stay) in determine the assignment of a shorter hospital stay. However, not all order to qualify for Medicare payment, procedure to the IPO list were as patients are candidates for minimally but procedures that are not on the IPO follows: (1) The invasive nature of the invasive PHA or THA. Commenters on list can be and very often are performed procedure; (2) the need for at least 24 the CY 2017 OPPS/ASC proposed rule on individuals who are inpatients (as hours of postoperative care; and (3) the comment solicitation on the TKA well as individuals who are hospital underlying physical condition of the procedure have stated that benefits of outpatients and ASC patients). Second, patient who would require the surgery outpatient PHA and THA procedures the IPO list status of a procedure has no (65 FR 18455). In 2000, the geometric include a likelihood of fewer effect on the MPFS professional mean average length of stay for the DRG complications, more rapid recovery, payment for the procedure. Whether or to which uncomplicated PHA and THA increased patient satisfaction, recovery not a procedure is on the IPO list is not procedures were assigned was 4.6 days, at home with the assistance of family in any way a factor in the MPFS and in 2016, the average length of stay members, and a likelihood of overall payment methodology. for current uncomplicated PHA and improved outcomes. On the contrary, THA procedures for the MS–DRG was unnecessary inpatient hospitalization 2. Topics and Questions for Public 2.7 days. exposes patients to the risk of hospital- Comments In the CY 2017 OPPS/ASC proposed acquired conditions such as infections In the CY 2018 OPPS/ASC proposed rule, we solicited public comments on and a host of other iatrogenic mishaps. rule (82 FR 33645), we sought public the possible removal of total knee We stated in the CY 2018 OPPS/ASC comments on whether we should arthroplasty (TKA) from the IPO list (81 proposed rule that, like most surgical remove the procedures described by FR 45679 through 45681). Included in procedures, both PHA and THA need to CPT codes 27125 and 27130 from the the public comments received related to be tailored to the individual patient’s IPO list from all interested parties, the removal of TKA from the IPO list needs. Patients with a relatively low including the following groups or were several comments in support of anesthesia risk and without significant individuals: Medicare beneficiaries and removal of THA from the IPO list as comorbidities who have family advocate associations for Medicare well. Among those commenters members at home who can assist them beneficiaries; orthopedic surgeons and expressing support for removal of THA may likely be good candidates for an physician specialty societies that from the IPO list were several surgeons outpatient PHA or THA procedure. represent orthopedic surgeons who and other stakeholders who believed These patients may be determined to perform PHA and/or THA procedures; that, given thorough preoperative also be able to tolerate outpatient hospitals and hospital trade screening by medical teams with rehabilitation in either an outpatient associations; and any other interested significant experience and expertise facility or at home postsurgery. On the stakeholders. We sought public involving hip replacement procedures, other hand, patients with multiple comments on the following questions: the THA procedure could be provided medical comorbidities, aside from their • Are most outpatient departments on an outpatient basis for some osteoarthritis, would more likely require equipped to provide PHA and/or THA Medicare beneficiaries. These inpatient hospitalization and possibly to some Medicare beneficiaries? commenters noted significant success postacute care in a skilled nursing • Can the simplest procedure involving same day discharge for facility or other facility. Surgeons who described by CPT codes 27125 and patients who met the screening criteria have discussed outpatient PHA and 27130 be performed in most outpatient and whose experienced medical teams THA procedures in public comments in departments? were able to perform the procedure response to our CY 2017 OPPS/ASC • Are the procedures described by early enough in the day for the patients proposed rule comment solicitation on CPT codes 27125 and 27130 sufficiently to achieve postoperative goals, allowing the TKA procedure have emphasized related to or similar to other procedures home discharge by the end of the day. the importance of careful patient we have already removed from the IPO The commenters believed that the selection and strict protocols to list? benefits of providing the THA optimize outpatient hip replacement • How often is the procedure procedure on an outpatient basis will outcomes. These protocols typically described by CPT codes 27125 and lead to significant enhancements in manage all aspects of the patient’s care, 27130 being performed on an outpatient
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basis (either in an HOPD or ASC) on Other commenters, including 2. Expansion of Services by Excepted non-Medicare patients? ambulatory surgery centers, physicians, Off-Campus Hospital Outpatient • Would it be clinically appropriate and beneficiaries, supported the Departments for some Medicare beneficiaries in removal of PHA and THA from the IPO In the CY 2018 OPPS/ASC proposed consultation with his or her surgeon and list. These commenters stated that the rule (82 FR 33645 through 33648), we other members of the medical team to procedures were appropriate for certain did not propose any policies to limit have the option of either a PHA or THA Medicare beneficiaries and most clinical service line expansion or procedure as a hospital outpatient, outpatient departments are equipped to volume increases at excepted off- which may or may not include a 24- provide THA to some Medicare campus provider-based departments hour period of recovery in the hospital beneficiaries. They also referenced their (PBDs). However, we stated that we after the operation? own personal successful experiences would continue to monitor claims data In addition, we sought public with outpatient THA. comments on whether the PHA and for changes in billing patterns and Finally, commenters stated concerns utilization, and continue to invite THA procedures may meet the criteria regarding the effect of removing THA on to be added to the ASC Covered public comments on the issue of service the pricing methodologies, target expansion. Procedures List. We refer readers to pricing, and reconciliation process of section XII.C.1.d. of this final rule with We received a number of comments the procedure in certain Medicare from various stakeholders regarding comment period for a complete payment models (that is, the CJR and discussion of the ASC Covered both clinical service line expansion and the BPCI models). They requested volume increases, as well as other topics Procedures List. modifications to these models if the Finally, as noted when we solicited not discussed in the CY 2018 OPPS/ THA procedure is removed from the IPO public comment on removing the TKA ASC proposed rule, including relocation list and requested that these procedures procedure from the IPO list in the CY and change of ownership. We appreciate be suspended from quality programs 2017 rulemaking, we solicited public all of the comments received, and we such as the Hospital Readmissions comment on the effect of removing the will consider them as we consider TKA procedure from the IPO list on the Reduction Program, the Hospital Value- whether to pursue future rulemaking on CJR Model and the BPCI Model. We Based Purchasing Program, and Hospital these issues. refer readers to the CY 2017 OPPS/ASC Inpatient Quality Reporting Program if We also received some public proposed rule for a discussion of they are removed from the IPO list. comments regarding issues that are questions we raised for public Response: We thank the commenters outside the scope of the policies comments, and we again sought public for their detailed responses. We will addressed in the CY 2018 OPPS/ASC comment on the effect of removing the consider these comments in future proposed rule, including comments PHA and THA procedures from the IPO policymaking. related to the proposed payment list on these models. For a discussion of X. Nonrecurring Policy Changes adjustment applied for nonexcepted these models in the CY 2017 items and services furnished by rulemaking, we refer readers to 81 FR A. Payment for Certain Items and nonexcepted off-campus PBDs, which 79698 through 79699. Services Furnished by Certain Off- are addressed in the CY 2018 MPFS Comment: Numerous commenters Campus Departments of a Provider final rule, and comments regarding representing a variety of stakeholders, 1. Background technical billing questions. With respect including physicians and other care to the payment adjustment for providers, individual stakeholders, Section 603 of the Bipartisan Budget nonexcepted items and services specialty societies, hospital Act of 2015 (Pub. L. 114–74), enacted on furnished by nonexcepted off-campus associations, hospital systems, ASCs, November 2, 2015, amended section PBDs and changes to the payment device manufacturers, and beneficiaries 1833(t) of the Act by amending relativity adjuster, we refer readers to responded to our solicitation of paragraph (1)(B) and adding a new the CY 2018 MPFS final rule for that comments regarding the removal of PHA paragraph (21). As a general matter, information and, more broadly, for the and THA from the IPO list. The under sections 1833(t)(1)(B)(v) and payment rates under the MPFS that will comments were diverse and some were (t)(21) of the Act, applicable items and apply to nonexcepted items and services similar to the comments we received on services furnished by certain off campus furnished by nonexcepted off-campus our proposal to remove TKA from the outpatient departments of a provider on PBDs for CY 2018. We expect the CY IPO list. Some commenters, including or after January 1, 2017, will not be 2018 MPFS final rule to be issued on or hospital systems and associations, as considered covered OPD services as about the same date as this OPPS/ASC well as specialty societies and defined under section 1833(t)(1)(B) of final rule with comment. Comments physicians, stated that it would not be the Act for purposes of payment under submitted regarding technical billing clinically appropriate to remove PHA the OPPS and will instead be paid questions are addressed through and THA from the IPO list, indicating ‘‘under the applicable payment system’’ applicable program instructions. that the patient safety profile of under Medicare Part B if the outpatient THA and PHA in the non- requirements for such payment are 3. Section 16002 of the 21st Century Medicare population is not well- otherwise met. To be considered part of Cures Act (Treatment of Cancer established. Commenters representing a hospital, an off-campus department of Hospitals in Off-Campus Outpatient orthopedic surgeons also stated that a hospital must meet the provider-based Department of a Provider Policy) patients requiring a hemiarthroplasty criteria established under 42 CFR As discussed in the CY 2018 OPPS/ (PHA) for fragility fractures are by 413.65. The implementation of section ACS proposed rule (82 FR 33648), in the nature higher risk, suffer more extensive 603 of the Bipartisan Budget Act of 2015 CY 2017 OPPS/ASC final rule with comorbidities and require closer was finalized in the CY 2017 OPPS/ASC comment period (81 FR 79699), we monitoring and preoperative final rule with comment period (81 FR finalized a number of proposals to optimization; therefore, it would not be 79699 through 79719) and interim final implement section 603 of the Bipartisan medically appropriate to remove the rule with comment period (79720 Budget Act of 2016 (Pub. L. 114–74), PHA procedure from the IPO list. through 79729). enacted on November 2, 2015, which
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amended section 1833(t) of the Act. reduction, the Secretary may consider C. Appropriate Use Criteria for Specifically, this provision amended the making an additional percentage point Advanced Diagnostic Imaging Services OPPS statute to require that certain reduction to the target PCR that takes Section 218(b) of the Protecting items and services furnished by certain into account payment rates for Access to Medicare Act of 2014 (PAMA) off-campus PBDs on or after January 1, applicable items and services described (Pub. L. 113–93) added subsection (q) to 2017 will not be considered covered in section 1833(t)(21)(C) of the Act other section 1834 of the Act, which directs OPD services as defined under section than for services furnished by certain the Secretary to establish a program to 1833(t)(1)(B) of the Act for purposes of cancer hospitals. Further, in making any promote the use of appropriate use payment under the OPPS, and instead budget neutrality adjustments under criteria (AUC) for advanced diagnostic will be paid ‘‘under the applicable section 1833(t) of the Act, the Secretary imaging services (the AUC program). payment system’’ under Medicare Part B shall not take into account the reduced Section 1834(q)(1)(B) of the Act defines if the requirements for such payment are AUC as criteria that are evidence-based otherwise met. In the CY 2017 OPPS/ expenditures that result from (to the extent feasible) and assist ASC final rule with comment period (81 application of section 1833(t)(18)(C) of professionals who order and furnish FR 79699), we established the Medicare the Act. We refer readers to section II.F. applicable imaging services to make the Physician Fee Schedule as the of this final rule with comment period most appropriate treatment decisions for ‘‘applicable payment system’’ for the for a discussion on the calculation of the a specific clinical condition. The majority of the nonexcepted items and target PCR for cancer hospitals for CY current policies for the AUC program for services furnished by nonexcepted off- 2018. advanced diagnostic imaging services campus PBDs. B. Medicare Site-of-Service Price Section 16002(a) of the 21st Century are codified in the regulations at 42 CFR Cures Act (Pub. L. 114–255) amended Transparency (Section 4011 of the 21st 414.94. the Act at section 1833(t)(20)(B) and Century Cures Act) There are four components of the provided that, with respect to applicable AUC program for advanced diagnostic Section 4011 of the 21st Century imaging services program. In the CY items and services furnished during Cures Act (Pub. L. 114–255), enacted on 2017 or a subsequent year, the term ‘‘off- 2016 MPFS final rule with comment December 13, 2016, amended section campus outpatient department of a period (80 FR 71102 through 71116 and 1834 of the Act by adding a new provider’’ excludes certain cancer 80 FR 71380 through 71382), we hospitals. To meet this exclusion, subsection (t). New section 1834(t) of addressed the first component of the section 16002(a) requires that such the Act provides that, in order to Medicare AUC program. The first cancer hospitals (1) be described in facilitate price transparency with component includes the requirements section 1886(d)(1)(B)(v) of the Act; and respect to items and services for which and process for the establishment and (2) for hospital outpatient departments payment may be made either to a specification of the AUC. In the CY 2017 that meet the requirements for 42 CFR hospital outpatient department or to an MPFS final rule (81 FR 80403 through 413.65, after November 1, 2015 and ambulatory surgical center under Title 80428 and 81 FR 80554 through 80555), before December 15, 2016, that the XVIII, the Secretary shall, for 2018 and we addressed the second component of Secretary has received from the provider each year thereafter, make available to the AUC program. The second an attestation that the department met the public via a searchable Web site, component includes the specification of such requirements not later than 60 with respect to an appropriate number qualified clinical decision support days after the date of enactment of of items and services, the estimated mechanisms (CDSMs). A CDSM is the section 16002 (December 13, 2016), or, payment amount for the item or service electronic tool through which the ordering practitioner consults AUC. In for departments that meet the under the OPPS and ASC payment the CY 2018 OPPS/ASC proposed rule requirements after December 13, 2016, system and the estimated beneficiary (82 FR 33648 and 33649), we stated that the Secretary has received from the liability applicable to the item or provider an attestation that the we had proposed in the CY 2018 MPFS service. In the CY 2018 OPPS/ASC proposed rule to address the third department met the requirements not proposed rule (82 FR 33648), we later than 60 days after the date the component of the AUC program. The announced our plan to establish the department first met the requirements of third component includes the searchable Web site required by section 42 CFR 413.65. As we stated in the CY requirements for an ordering 2018 OPPS/ASC proposed rule, through 1834(t) of the Act. We indicated that professional to consult with a qualified operational guidance, we have provided details regarding the Web site will be CDSM when ordering an applicable direction to all MACs regarding this issued through our subregulatory imaging service, and for the furnishing provision. We also have provided process. We stated in the proposed rule professional to include that consultation guidance on this provision to hospital that we anticipate that the Web site will information on claims for the service providers, which can be found on the be made available in early CY 2018. that is furnished in an applicable setting CMS Web site at: https://www.cms.gov/ Comment: One commenter requested and paid under an applicable payment Medicare/Medicare-Fee-for-Service- that CMS ensure that the Web site is system. Based on the statutory language Payment/HospitalOutpatientPPS/ designed in a user-friendly manner, and of section 1834(q)(4)(B) of the Act, the Downloads/Sections-16001-16002.pdf. err on the side of including services for AUC program applies to advanced Section 16002(b) of Public Law 114– display. Another commenter requested imaging services for which payment is 255 amended section 1833(t)(18) of the that Web site users be provided with the made under the following applicable Act by adding a new subparagraph (C) payment systems: The MPFS; the OPPS; proper context for understanding some that requires the Secretary, in applying and the ASC payment system. The of the reasons for potential cost 42 CFR 419.43(i) for services furnished fourth component of the program is differences. on or after January 1, 2018, to use a prior authorization for outlier ordering target payment-to-cost ratio (PCR) that is Response: We appreciate these professionals. This component will be 1 percentage point less than the target comments and will take them into discussed in future rulemaking. PCR that would otherwise apply. In consideration as we develop the Web We indicated in the CY 2018 OPPS/ addition to the 1 percentage point site. ASC proposed rule that public
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comments related to the requirements supervision of individual hospital conditions of participation for hospitals for the AUC program should be outpatient therapeutic services. In and other Medicare rules regarding addressed in response to the CY 2018 addition, we extended the enforcement supervision. We welcomed public MPFS proposed rule. Therefore, we instruction through CY 2012 and CY comments on this proposal. refer readers to the CY 2018 MPFS final 2013. The enforcement instruction has Comment: A few commenters rule for further information governing not been in effect since December 31, opposed the proposal to reinstate the the Medicare AUC program and the 2013. Congress has taken legislative enforcement instruction for CAHs and finalized policies for CY 2018, including action (Pub. L. 113–198 and Pub. L. small rural hospitals because of summaries of any public comments we 114–112) to extend nonenforcement of concerns about patient safety or having received on the proposals in the CY the direct supervision requirement for qualified physicians perform certain 2018 MPFS proposed rule and our hospital outpatient therapeutic services medical services. One commenter responses to those comments. in CAHs and small rural hospitals believed that supervision requirements having 100 or fewer beds since should be applied uniformly to D. Enforcement Instruction for the December 31, 2013. The latest hospitals in all care settings to ensure Supervision of Outpatient Therapeutic legislative action (Pub. L. 114–255) patient safety. Another commenter Services in Critical Access Hospitals extended nonenforcement until focused on radiation oncology services (CAHs) and Certain Small Rural December 31, 2016. The current and believed that those services should Hospitals enforcement instruction is available on be delivered by personnel trained in As discussed in the CY 2018 OPPS/ the CMS Web site at: https:// radiation oncology. The commenter ASC proposed rule (82 FR 33649), in the www.cms.gov/Regulations-and- understood concerns about physician CY 2009 OPPS/ASC proposed rule and Guidance/Guidance/FACA/Downloads/ availability in rural areas, but final rule with comment period (73 FR Moratorium-on-Hospital-Supervision- encouraged CMS to create more 41518 through 41519 and 73 FR 68702 Enforcement.pdf. incentives for radiation oncologists to through 68704, respectively), we As discussed in the CY 2018 OPPS/ practice in rural areas instead of not clarified that direct supervision is ASC proposed rule, stakeholders have enforcing requirements for direct required for hospital outpatient consistently requested that CMS supervision. therapeutic services covered and paid continue the nonenforcement of the Response: We agree that patient safety by Medicare that are furnished in direct supervision requirement for is a critically important consideration hospitals as well as in PBDs of hospital outpatient therapeutic services for each service, and that only qualified hospitals, as set forth in the CY 2000 for CAHs and small rural hospitals physicians and nonphysician OPPS final rule with comment period having 100 or fewer beds. Stakeholders practitioners who are practicing within (65 FR 18525). In the CY 2010 OPPS/ stated that some small rural hospitals their State scope of practice should ASC final rule with comment period (74 and CAHs have insufficient staff perform and oversee therapeutic FR 60575 through 60591), we finalized available to furnish direct supervision. services, as applicable. We note that our a technical correction to the title and The primary reason stakeholders cited proposal did not change State licensure text of the applicable regulation at 42 for this request is the difficulty that and scope of practice requirements. We CFR 410.27 to clarify that this standard CAHs and small rural hospitals have in would expect all hospitals to ensure that applies in CAHs as well as hospitals. In recruiting physicians and nonphysician appropriate clinical personnel direct response to concerns expressed by the practitioners to practice in rural areas. and oversee each beneficiary’s care such hospital community, in particular CAHs These stakeholders noted that it is that patient safety is not compromised. and small rural hospitals, that they particularly difficult to furnish direct As stated in our proposal, we are not would have difficulty meeting this supervision for critical specialty aware of any quality of care complaints standard, on March 15, 2010, we services, such as radiation oncology from beneficiaries or providers relating instructed all MACs not to evaluate or services, that cannot be directly to the level of physician supervision for enforce the supervision requirements for supervised by a hospital emergency hospital outpatient therapeutic services. therapeutic services provided to department physician or nonphysician In addition, CAHs and small rural outpatients in CAHs from January 1, practitioner because of the volume of hospitals will continue to be subject to 2010 through December 31, 2010, while emergency patients or lack of specialty the Medicare conditions of participation the agency revisited the supervision expertise. In addition, we are not aware for hospitals and other Medicare rules policy during the CY 2011 OPPS/ASC of any quality of care complaints from regarding supervision. rulemaking cycle. beneficiaries or providers relating to the Comment: Several commenters Due to continued concerns expressed enforcement instruction related to direct supported the proposal for CYs 2018 by CAHs and small rural hospitals, we physician supervision. and 2019. Some commenters suggested extended this notice of nonenforcement Therefore, in the CY 2018 OPPS/ASC that CMS adopt the nonenforcement (‘‘enforcement instruction’’) as an proposed rule, we proposed to reinstate policy for CY 2017 and permanently interim measure for CY 2011, and the enforcement instruction for beyond CY 2019. Commenters also expanded it to apply to small rural outpatient therapeutic services suggested changing the level of hospitals having 100 or fewer beds (75 furnished in CAHs and small rural supervision for some or most hospital FR 72007). We continued to consider hospitals having 100 or fewer beds for outpatient therapeutic services, such as the issue further in our annual OPPS CYs 2018 and 2019 to give these CAHs therapy services, to general supervision notice-and-comment rulemaking, and and small rural hospitals more time to as the default supervision level. These implemented an independent review comply with the supervision commenters also suggested that the process in 2012 to obtain advice from requirements for outpatient therapeutic change in supervision level should the HOP Panel on this matter (76 FR services and to give all parties apply to additional categories of 74360 through 74371). Under this additional time to submit specific hospitals or to all hospitals and not just process used since CY 2012, the HOP services to be evaluated by the HOP for CAHs and small rural hospitals. The Panel considers and advises CMS Panel for a recommended change in the commenters believed changing the level regarding stakeholder requests for supervision level. We stated that these of supervision for all hospitals will help changes in the required level of hospitals will continue to be subject to rural providers with the shortages of
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health care professionals and reduce the X-ray imaging services and computed 2021, or 2022, that would otherwise be regulatory burden on providers while radiography imaging services. determined under section 1833(t) of the providing a level of supervision Section 1833(t)(16)(F)(i) of the Act Act (without application of consistent with the conditions of specifies that, effective for services subparagraph (F)(ii) and before participation for CAHs. furnished during 2017 or a subsequent application of any other adjustment), Response: We appreciate the support year, the payment under the OPPS for will be reduced by 7 percent, and if for this proposal. Permanent changes to imaging services that are X-rays taken such services are furnished during CY the supervision level for outpatient using film (including the X-ray 2023 or a subsequent year, by 10 therapeutic services for all hospitals are component of a packaged service) that percent. For purposes of this reduction, beyond the scope of this proposal. We would otherwise be made under the computed radiography technology is note that we have an established process OPPS (without application of defined in section 1848(b)(9)(C) of the for stakeholders to submit specific subparagraph (F)(i) and before Act as cassette-based imaging which services to be evaluated by the HOP application of any other adjustment utilizes an imaging plate to create the Panel for a recommended change in the under section 1833(t) of the Act) shall image involved. (82 FR 33650). supervision levels. Likewise, be reduced by 20 percent. Section To further implement this provision, permanently reinstating the 1833(t)(16)(F)(iii) of the Act provides we stated in the proposed rule that we enforcement instruction after CY 2019 is that the reductions made under section were establishing a new modifier (82 FR beyond the scope of this proposal. As 1833(t)(16)(F) of the Act shall not be 33650), specifically, ‘‘FY’’ (X-ray taken we stated in the CY 2018 OPPS/ASC considered an adjustment under section using computed radiography proposed rule, we proposed to reinstate 1833(t)(2)(E) of the Act, and shall not be technology/cassette-based imaging), as the enforcement instruction for 2 years implemented in a budget neutral permitted by section 1833(t)(16)(F)(iv) to give small rural hospitals and CAHs manner. of the Act, that would be reported on additional time to comply with the As discussed in the CY 2018 OPPS/ claims to identify those HCPCS codes supervision requirements for outpatient ASC proposed rule (82 FR 33649 that describe X-rays taken using therapeutic services and to give all through 33650), consistent with section computed radiography technology. (We parties additional time to submit 1833(t)(16)(F)(iv) of the Act, which note that modifier ‘‘FY’’ was listed as specific services to be evaluated by the requires the implementation of the placeholder ‘‘XX’’ in the CY 2018 OPPS/ HOP Panel for a recommended change reductions in payment set forth in ASC proposed rule and that we in the supervision level. subparagraph (F) through appropriate indicated (82 FR 33650) that the 2-digit With respect to applying the mechanisms, which may include modifier and long descriptor would be nonenforcement policy to CY 2017, we modifiers, we implemented section described in this final rule with proposed to reinstate the enforcement 1833(t)(16)(F)(i) of the Act by comment period.) We proposed that the instruction prospectively, for services establishing the modifier ‘‘FX’’ (X-ray payment reduction would be taken administered beginning on the effective taken using film), effective January 1, when this payment modifier is reported date of this final rule with comment 2017. The payment for X-rays taken with the applicable HCPCS code(s) to period, which is scheduled for January using film and furnished during 2017 or describe imaging services that are taken 1, 2018; and we are finalizing that a subsequent year is reduced by 20 using computed radiography technology proposal. We anticipate issuing percent when modifier ‘‘FX’’ (X-ray (82 FR 33650). In the proposed rule, we guidance outside of this rule to address taken using film) is reported with the stated that the applicable HCPCS codes enforcement policy for the direct appropriate HCPCS codes. The describing imaging services could be supervision requirement for outpatient applicable HCPCS codes describing found in Addendum B to the proposed therapeutic services for CY 2017. imaging services can be found in rule (which is available via the Internet After consideration of the public Addendum B to this final rule with on the CMS Web site). When payment comments we received, we are comment period (which is available via for an X-ray service taken using finalizing our proposal, without the Internet on the CMS Web site). computed radiography imaging is modification, to reinstate the When payment for an X-ray service packaged into the payment for another nonenforcement policy for direct taken using film is packaged into the item or service under the OPPS, no supervision enforcement of outpatient payment for another item or service separate payment for the X-ray service therapeutic services furnished in CAHs under the OPPS, no separate payment is made and, therefore, there is no and small rural hospitals having 100 or for the X-ray service is made and, payment amount that can be attributed fewer beds, and to reinstate our therefore, there is no payment amount to the X-ray. Accordingly, the amount of enforcement instruction for CYs 2018 that can be attributed to the X-ray the payment reduction for a packaged X- and 2019. service. Accordingly, the amount of the ray service would be $0 (7 percent of $0, payment reduction for a packaged film and 10 percent of $0). We invited public E. Payment Changes for Film X-Ray X-ray service is $0 (20 percent of $0). comments on these proposals. Services and Payment Changes for X- Further discussion of these policies and Comment: One commenter believed Rays Taken Using Computed modifier ‘‘FX’’ can be found in the CY that reporting the modifier ‘‘FY’’ would Radiography Technology 2017 OPPS/ASC final rule with be burdensome to hospitals and create Section 502 of Division O, title V of comment period (81 FR 79729 through another opportunity for miscoding. the Consolidated Appropriations Act, 79730). Response: Modifier ‘‘FY’’ will be 2016 (Pub. L. 114–113), which was Section 1833(t)(16)(F)(ii) of the Act reported by hospitals only to identify enacted on December 18, 2015, contains provides for a phased-in reduction of those services that involve X-rays taken provisions to incentivize the transition payments for imaging services that are using computed radiography from traditional X-ray imaging to digital taken using computed radiography technology. We do not believe that the radiography. In particular, section technology (as defined in section use of this modifier would be unduly 502(b) of Public Law 114–113 amended 1848(b)(9)(C) of the Act). Payments for burdensome to hospitals. The reporting section 1833(t)(16) of the Act by adding such services (including the X-ray of this modifier is similar to the subparagraph (F), which includes component of a packaged service) reporting of other existing modifiers that provisions that limit payment for film furnished during CY 2018, 2019, 2020, hospitals currently include when
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reporting HCPCS codes and modifiers payments for X-rays taken using penalizes hospitals, particularly in rural for procedures, services, and items on computed radiography technology will and underserved communities that do Medicare claims under the OPPS. To the be reduced by 7 percent during CY not have the financial resources to extent the hospital is already reporting 2018, 2019, 2020, 2021, or 2022, and update their equipment systems, but a code for an X-ray taken using thereafter by 10 percent when furnished would also force small clinics and computed radiography, appending the during CY 2023 or a subsequent year. hospitals to no longer provide imaging modifier to the same claim should not Specifically, the payment reduction will services that require computed be unduly burdensome. Further, apply when the ‘‘FY’’ modifier is radiography technology. Medicare is required by law to make reported with the applicable HCPCS Response: We are required by section this payment adjustment and the code(s) to describe imaging services that 1833(t)(16)(F) of the Act to reduce commenter did not offer an alternative are taken using computed radiography payments under the OPPS for X-rays (less burdensome) method by which technology. In addition, when payment taken using film and X-rays taken using Medicare could ensure payment for an X-ray service taken using computed radiography technology. We accuracy for these services. computed radiography imaging is note that the statute did not address Comment: One commenter urged packaged into the payment for another either bonus payments to incentivize CMS to publish the list of specific CPT item or service under the OPPS, no the transition to digital radiography and HCPCS codes that would apply to separate payment for the X-ray service technology or a delay in the this new modifier (‘‘FY’’) as well as to is made and, therefore, there is no implementation of section 1833(t)(16)(F) the film X-ray modifier (‘‘FX’’) that was payment amount that can be attributed of the Act. implemented last year. The commenter to the X-ray. Accordingly, the amount of After consideration of the public indicated that not having published lists the payment reduction for a packaged comments we received, we are is burdensome to providers and also X-ray service will be $0 (7 percent of $0, finalizing our proposal to establish a exposes them to additional risk of audit. and 10 percent of $0). We note that the new modifier ‘‘FY’’ (X-ray taken using This same commenter offered to provide applicable HCPCS codes describing computed radiography technology/ technical assistance from its X-ray imaging services could be found in cassette-based imaging) as permitted by manufacturer members on the creation Addendum B to this final rule with section 1833(t)(16)(F)(iv) of the Act, that of such a list. comment period (which is available via will be reported on claims to identify Response: We thank the commenter the Internet on the CMS Web site). those HCPCS codes that describe X-rays for the offer of assistance. However, we Comment: Some commenters taken using computed radiography expect hospitals to appropriately report supported the transition to digital technology. The payment reduction will the ‘‘FY’’ modifier to identify those radiography. However, several be taken when this modifier is reported services that involve X-rays taken using commenters expressed concern with the with the applicable HCPCS code(s) to computed radiography technology, and statute requiring hospitals to upgrade to describe imaging services that are taken to appropriately report the ‘‘FX’’ digital radiography systems and using computed radiography modifier to identify those X-ray services indicated that the requirement is technology. The applicable HCPCS taken using film. The applicable HCPCS financially burdensome and difficult to codes describing imaging services can codes describing imaging services can justify. One commenter stated that a be found in Addendum B to this final be found in Addendum B to this final typical computed radiography reader rule with comment period (which is rule with comment period (which is can cost between $60,000 and $80,000, available via the Internet on the CMS available via the Internet on the CMS while a new digital radiography system Web site). Web site). can cost up to $200,000. Another In addition, although we adopted the Comment: One commenter requested commenter indicated that it estimated payment reduction for the film X-ray detailed guidance on the its cost to replace or retrofit its nearly imaging services, as required by section implementation of the computed 120 computed radiography systems to 1833(t)(16)(F)(i) of the Act in the CY radiography to digital X-ray payment digital radiography systems to be 2017 OPPS/ASC final rule with differential. Specifically, the commenter approximately $11 million. comment period, we did not adopt stated that CMS instructions are unclear One commenter suggested that, to corresponding regulation text. as to which specific CPT and HCPCS truly incentivize the transition to digital Therefore, in the CY 2018 OPPS/ASC codes require the amended modifier. radiography technology, CMS should proposed rule (82 FR 33650 and 33723 Prior to implementation, the commenter offer bonus payments similar to the through 33724), we proposed to add suggested that CMS publish all recently proposed 2015 Certified Health new regulation text at 42 CFR 419.71 to applicable codes requiring the modifier, Record Technology (CEHRT) bonus codify our existing policies and our with specific billing guidance. under the Quality Payment Program proposed policies for computed Response: As indicated above, the (QPP) Year 2. This same commenter radiography technology services. We new ‘‘FY’’ modifier will be used to recommended that, in lieu of bonus proposed to add the definition of report those services that involve X-rays payments, CMS work with Congress to ‘‘computed radiography technology,’’ as taken using computed radiography implement a delay of these cuts for the it is defined in section 1848(b)(9)(C) of technology. HOPDs should append useful life of a typical computed the Act, in paragraph (a) of proposed modifier ‘‘FY’’ to those HCPCS codes radiography machine (5 years) to allow new § 419.71. We stated that the that involve the use of X-ray systems practices time to replace older proposed regulation text under taken using computed radiography equipment with digital radiography paragraph (b) of proposed new § 419.71 technology. We believe that hospitals technology. would specify the 20-percent reduction should know when they are billing a Other commenters further indicated for film X-ray imaging services. We HCPCS code that involves the use of an there is no clinical benefit to using proposed that the phased-in payment X-ray taken using computed digital radiography systems, and that, reduction for computed radiography radiography and, therefore, we are not for certain clinical situations, computed technology imaging services would be providing a list of codes. radiography systems are preferable. Still codified at paragraph (c) of proposed In addition, in accordance with other commenters stated that the new § 419.71. Finally, we proposed that section 1833(t)(16)(F)(ii) of the Act, reduction in payments not only paragraph (d) of proposed new § 419.71
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would provide that the payment obtained from storage. Specimens stored care a beneficiary receives in the reductions taken under the section are for 30 days or less continued to have a hospital. When the 14-day rule applies, not considered adjustments under DOS of the date the specimen was laboratory tests are not bundled into the section 1833(t)(2)(E) of the Act and are collected. hospital stay, but are instead paid separately under Medicare Part B (as not implemented in a budget neutral 2. Current Medicare DOS Policy (‘‘14- explained in more detail below). manner. We invited public comments Day Rule’’) on this proposed regulation text. We also revised the DOS requirements We did not receive any public In the final rule with comment period for a chemotherapy sensitivity test comments on our proposed regulation entitled, in relevant part, ‘‘Revisions to performed on live tissue. As discussed text. Therefore, we are finalizing our Payment Policies, Five-Year Review of in the MPFS final rule (71 FR 69706), proposal to codify our previously Work Relative Value Units, Changes to we agreed with commenters that these adopted and newly finalized policies the Practice Expense Methodology tests, which are primarily used to regarding section 1833(t)(16)(F) of the Under the Physician Fee Schedule, and determine post-hospital chemotherapy Act, without modifications. Other Changes to Payment Under Part care for patients who also require B’’ published in the Federal Register on hospital treatment for tumor removal or F. Revisions to the Laboratory Date of December 1, 2006 (MPFS final rule) (71 resection, appear to be unrelated to the Service Policy FR 69705 through 69706), we added a hospital treatment in cases where it 1. Background on the Medicare Part B new § 414.510 in Title 42 of the CFR would be medically inappropriate to Laboratory Date of Service Policy regarding the clinical laboratory DOS collect a test specimen other than at the requirements and revised our DOS time of surgery, especially when the As we discussed in the CY 2018 policy for stored specimens. We OPPS/ASC proposed rule (82 FR 33650), specific drugs to be tested are ordered explained in the MPFS final rule that at least 14 days following hospital the date of service (DOS) is a required the DOS of a test may affect payment for data field on all Medicare claims for discharge. As a result, we revised the the test, especially in situations in DOS policy for chemotherapy laboratory services. However, a which a specimen that is collected laboratory service may take place over a sensitivity tests, based on our while the patient is being treated in a understanding that the results of these period of time—the date the physician hospital setting (for example, during a orders the laboratory test, the date the tests, even if they were available surgical procedure), is later used for immediately, would not typically affect specimen is collected from the patient, testing after the patient has been the date the laboratory accesses the the treatment regimen at the hospital. discharged from the hospital. We noted Specifically, we modified the DOS for specimen, the date the laboratory that payment for the test is usually performs the test, and the date results chemotherapy sensitivity tests bundled with payment for the hospital performed on live tissue in are produced may occur on different service, even where the results of the dates. In the final rule on coverage and § 414.510(b)(3) so that the DOS is the test did not guide treatment during the date the test was performed if the administrative policies for clinical hospital stay. To address concerns diagnostic laboratory services published following conditions are met: raised for tests related to cancer • The decision regarding the specific in the Federal Register on November 23, recurrence and therapeutic chemotherapeutic agents to test is made 2001 (66 FR 58791 through 58792), we interventions, we finalized at least 14 days after discharge; adopted a policy under which the DOS modifications to the DOS policy in • The specimen was collected while for clinical diagnostic laboratory § 414.510(b)(2)(i) for a test performed on the patient was undergoing a hospital services generally is the date the a specimen stored less than or equal to surgical procedure; specimen is collected. 30 calendar days from the date it was • It would be medically inappropriate A special rule was developed to apply collected (a non-archived specimen), so to have collected the sample other than to ‘‘archived’’ specimens. For laboratory that the DOS is the date the test was during the hospital procedure for which tests that use an archived specimen, we performed (instead of the date of the patient was admitted; established that the DOS is the date the collection) if the following conditions • The results of the test do not guide specimen was obtained from storage (66 are met: treatment provided during the hospital FR 58792). • The test is ordered by the patient’s stay; and In 2002, we issued Program physician at least 14 days following the • The test was reasonable and Memorandum AB–02–134 which date of the patient’s discharge from the medically necessary for the treatment of permitted contractors discretion in hospital; an illness. making determinations regarding the • The specimen was collected while We explained in the MPFS final rule length of time a specimen must be the patient was undergoing a hospital that, for chemotherapy sensitivity tests stored to be considered ‘‘archived.’’ In surgical procedure; that meet this DOS policy, Medicare response to comments requesting that • It would be medically inappropriate would allow separate payment under we issue a national standard to clarify to have collected the sample other than Medicare Part B, that is, separate from when a stored specimen can be during the hospital procedure for which the payment for hospital services. considered ‘‘archived,’’ in the the patient was admitted; 3. Billing and Payment for Laboratory Procedures for Maintaining Code Lists • The results of the test do not guide Services Under the OPPS in the Negotiated National Coverage treatment provided during the hospital Determinations for Clinical Diagnostic stay; and As discussed in the CY 2018 OPPS/ Laboratory Services final notice, • The test was reasonable and ASC proposed rule (82 FR 33651), the published in the Federal Register on medically necessary for the treatment of DOS requirements at 42 CFR 414.510 February 25, 2005 (70 FR 9357), we an illness. are used to determine whether a defined an ‘‘archived’’ specimen as a As we stated in the MPFS final rule, hospital bills Medicare for a clinical specimen that is stored for more than 30 we established these five criteria, which diagnostic laboratory test (CDLT) or calendar days before testing. We we refer to as the ‘‘14-day rule,’’ to whether the laboratory performing the established that the DOS for archived distinguish laboratory tests performed test bills Medicare directly. This is specimens is the date the specimen was as part of post-hospital care from the because separate regulations at 42 CFR
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410.42(a) and 411.15(m) generally different pattern of clinical use, which individual patient will develop a certain provide that Medicare will not pay for may make them generally less tied to a condition(s) or respond to a particular a service furnished to a hospital patient primary service in the hospital therapy(ies); provides new clinical during an encounter by an entity other outpatient setting than the more diagnostic information that cannot be than the hospital unless the hospital has common and routine laboratory tests obtained from any other test or an arrangement (as defined in 42 CFR that are packaged. combination of tests; and may include 409.3) with that entity to furnish that For similar reasons, in the CY 2017 other assays. particular service to its patients, with OPPS/ASC final rule with comment Or: certain exceptions and exclusions. period, we extended the exclusion to • Criterion (B): The test is cleared or These regulations, which we will call also apply to all ADLTs that meet the approved by the Food and Drug the ‘‘under arrangements’’ provisions in criteria of section 1834A(d)(5)(A) of the Administration. this discussion, require that if the DOS Act.32 We stated that we will assign Generally, under the revised CLFS, falls during an inpatient or outpatient status indicator ‘‘A’’ (Separate payment ADLTs are paid using the same stay, payment for the laboratory test is under the CLFS) to ADLTs once a methodology based on the weighted usually bundled with the hospital laboratory test is designated an ADLT median of private payor rates as other service. under the CLFS. Laboratory tests that CDLTs. However, updates to ADLT Under our current rules, if a test are separately payable and are listed on payment rates occur annually instead of meets all DOS requirements in the CLFS are paid at the CLFS payment every 3 years. The payment § 414.510(b)(2)(i) or § 414.510(b)(3), the rates outside the OPPS. methodology for ADLTs is detailed in DOS is the date the test was performed, the CLFS final rule (81 FR 41076 4. ADLTs Under the New Private Payor and the laboratory would bill Medicare through 41083). Rate-Based CLFS directly for the test and would be paid 5. Discussion of Potential Revisions to Section 1834A of the Act, as under the Clinical Laboratory Fee the Laboratory DOS Policy in the CY established by section 216(a) of the Schedule (CLFS) directly by Medicare. 2018 OPPS/ASC Proposed Rule However, if the test does not meet the Protecting Access to Medicare Act of DOS requirements in § 414.510(b)(2)(i) 2014 (PAMA), requires significant In the CY 2018 OPPS/ASC proposed or § 414.510(b)(3), the DOS is the date changes to how Medicare pays for rule (82 FR 33650 through 33653), we the specimen was collected from the CDLTs under the CLFS. Section 216(a) described the history of our laboratory patient. In that case, the hospital would of PAMA also establishes a new DOS policy and discussed potentially bill Medicare for the test and then subcategory of CDLTs known as ADLTs modifying the DOS policy for certain would pay the laboratory that performed with separate reporting and payment ADLTs and molecular pathology tests. the test, if the laboratory provided the requirements under section 1834A of We explained that, recently, we have test under arrangement. the Act. In the CLFS final rule heard from certain laboratory In recent rulemakings, we have published in the Federal Register on stakeholders about operational issues reviewed appropriate payment under June 23, 2016, entitled ‘‘Medicare the current laboratory DOS policy the OPPS for certain diagnostic tests Program; Medicare Clinical Diagnostic creates for hospitals and laboratories that are not commonly performed by Laboratory Tests Payment System Final with regard to molecular pathology tests hospitals. In CY 2014, we finalized a Rule’’ (CLFS final rule) (81 FR 41036), and laboratory tests they expect will be policy to package certain CDLTs under we implemented the requirements of designated by CMS as ADLTs that meet the OPPS (78 FR 74939 through 74942 section 1834A of the Act. the criteria of section 1834A(d)(5)(A) of and 42 CFR 419.2(b)(17) and 419.22(l)). As defined in § 414.502, an ADLT is the Act. These stakeholders have In CYs 2016 and 2017, we made some a CLDT covered under Medicare Part B expressed that although these particular modifications to this policy (80 FR that is offered and furnished only by a tests are not packaged under the OPPS, 70348 through 70350; 81 FR 79592 single laboratory. In addition, an ADLT under current DOS policy, if the tests through 79594). Under our current cannot be sold for use by a laboratory are ordered within 14 days of a patient’s policy, certain CDLTs that are listed on other than the single laboratory that discharge from the hospital, Medicare the CLFS are packaged as integral, designed the test or a successor owner. still treats the tests as though they were ancillary, supportive, dependent, or Also, an ADLT must meet either ordered and furnished by the hospital adjunctive to the primary service or Criterion (A), which implements section itself. Under those circumstances, services provided in the hospital 1834A(d)(5)(A) of the Act, or Criterion laboratories cannot directly seek outpatient setting during the same (B), which implements section Medicare payment for the molecular outpatient encounter and billed on the 1834A(d)(5)(B) of the Act, as follows: pathology test or ADLT. The hospital same claim. Specifically, we • Criterion (A): The test is an analysis must bill Medicare for the test, and the conditionally package most CDLTs and of multiple biomarkers of laboratory must seek payment from the only pay separately for a laboratory test deoxyribonucleic acid (DNA), hospital. Specifically, we noted that when it is: (1) The only service provided ribonucleic acid (RNA), or proteins; stakeholders representing laboratories to a beneficiary on a claim; (2) when combined with an empirically have expressed the following concerns: considered a preventive service; (3) a derived algorithm, yields a result that • The current DOS policy permits molecular pathology test; or (4) an predicts the probability a specific hospitals to bill for tests they did not advanced diagnostic laboratory test perform and that may have no (ADLT) that meets the criteria of section 32 Under section 1834A(d)(5)(A) of the Act, an relationship to or bearing on treatment 1834A(d)(5)(A) of the Act (78 FR 74939 ADLT is a CDLT covered under Medicare Part B received by the patient while in the through 74942; 80 FR 70348 through that is offered and furnished only by a single hospital. laboratory and not sold for use by a laboratory other • 70350; and 81 FR 79592 through 79594). than the original developing laboratory (or a The DOS policy may create In the CY 2016 OPPS/ASC final rule successor owner) and . . . ‘‘the test is an analysis inconsistent billing for specialty with comment period, we excluded all of multiple biomarkers of DNA, RNA, or proteins laboratories. For example, if the hospital combined with a unique algorithm to yield a single molecular pathology laboratory tests patient-specific result.’’ CMS has established a is located in a different jurisdiction than from packaging because we believed regulatory definition for this type of ADLT in 42 the MAC used by the laboratory, a these relatively new tests may have a CFR 414.502. different MAC may be billed.
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• Hospitals may be discouraged from hospital stay that preceded the test and These commenters stated that this utilizing ADLTs because billing for such therefore should have a DOS that is the approach would be consistent with how tests that are not performed by hospitals date of performance rather than the date tests are ordered and billed for under could create administrative and of collection. Medicare Advantage plans and financial complexities. As an example, we stated that we commercial insurers, which allow • The DOS policy is a potential would consider modifying 42 CFR laboratories to bill directly for these barrier to CMS’ goal of promoting 414.510(b) by adding a new paragraph tests. personalized medicine because the (5) to establish that in the case of a Commenters also reiterated previous policy may disproportionately impact molecular pathology test or an ADLT concerns regarding administrative and smaller laboratories performing that meets the criteria of section billing complexities resulting from the innovative diagnostic tests. 1834A(d)(5)(A) of the Act, the DOS must current DOS policy that may affect • Billing complexities may affect be the date the test was performed only timely beneficiary access to necessary beneficiary access to needed laboratory if: molecular pathology tests. These tests and therapies. For example, orders • The physician orders the test commenters noted that hospitals may be might be delayed until at least 14 days following the date of a hospital reluctant to order a test that the hospital after discharge or even canceled to outpatient’s discharge from the hospital itself does not perform until at least 14 avoid the DOS policy. This may restrict outpatient department; days following the date the patient is patient access to tests and reduce • The specimen was collected from a discharged from the hospital outpatient efficacy of treatment plans due to hospital outpatient during an encounter department so that the laboratory hospitals delaying or foregoing patient (as both are defined 42 CFR 410.2); performing the test may bill Medicare testing to avoid financial risk. • It would be medically inappropriate directly for the test. One commenter • The DOS policy may limit access to have collected the sample from the explained that, for molecular pathology for Medicare beneficiaries under hospital outpatient other than during tests performed by an independent original Medicare fee-for-service (that is, the hospital outpatient encounter; laboratory that is not affiliated with the • Medicare Part A and Part B) due to the The results of the test do not guide hospital, the administrative complexity fact that Medicare Advantage Plans treatment provided during the hospital of the current laboratory DOS policy under Medicare Part C and private outpatient encounter; and frequently leads hospitals to delay • payors allow laboratories to bill directly The test was reasonable and ordering of these tests. for tests they perform. medically necessary for the treatment of In addition, several commenters As we stated in the proposed rule (82 an illness. recommended specific modifications to FR 33652), we recognize that the current We requested specific comments on the potential revisions to laboratory laboratory DOS rule may impose this potential modification to the DOS policy discussed in the CY 2018 administrative difficulties for hospitals current laboratory DOS policy, which OPPS/ASC proposed rule. These and laboratories that furnish laboratory would allow laboratories to bill suggested modifications are summarized tests that are excluded from OPPS Medicare directly for molecular below. packaging and therefore paid separately pathology tests and ADLTs that meet the • Expand the laboratory tests subject at CLFS payment rates. Hospitals may criteria of section 1834A(d)(5)(A) of the to the DOS exception. Commenters be reluctant to bill Medicare for Act and have been granted ADLT status suggested that CMS expand the laboratory tests they do not perform, by CMS, when the specimen is collected laboratory tests subject to the potential which as noted by stakeholders, could during a hospital outpatient procedure DOS exception to include all ADLTs lead to delays in patient access to care. and the test is ordered after the patient (that is, both Criterion (A) and Criterion In light of the concerns raised by is discharged from the hospital (B) ADLTs) and all Multi-Analyte stakeholders, we stated in the proposed outpatient department. We also noted Assays with Algorithmic Analysis rule that we were considering potential that we would consider finalizing this (MAAA), Genomic Sequencing modifications to the DOS policy that modification (82 FR 33653). Procedures (GSP), and Proprietary would allow laboratories to bill Comment: Many commenters Laboratory Analysis (PLA) test codes, Medicare directly for certain laboratory supported revising the laboratory DOS even if they are not currently excluded tests excluded from the OPPS packaging policy so that laboratories may bill from the OPPS packaging policy. The policy. We noted that one approach Medicare and receive payment directly commenters argued that expanding the under consideration would create a new for ADLTs and molecular pathology potential revision to the DOS policy to exception to the DOS policy for tests performed on specimens collected include the aforementioned laboratory molecular pathology tests and ADLTs from hospital outpatients, which are tests would encompass all laboratory that meet the criteria of section excluded from the OPPS packaging testing that has a different pattern of 1834A(5)(A) of the Act and have been policy. The commenters indicated that clinical use from routine testing and granted ADLT status by CMS. As we revising the current laboratory DOS therefore is unconnected to the primary stated in the CY 2017 OPPS/ASC final policy so that the performing laboratory hospital outpatient service. rule with comment period (81 FR 79592 can bill Medicare directly for molecular • Remove the test order date through 79594), we believe these tests pathology tests and ADLTs is consistent requirement. Several commenters are relatively new and may have a with CMS’ policy of excluding recommended that CMS not finalize a different pattern of clinical use than ‘‘precision diagnostics’’ performed on requirement that the physician must more conventional laboratory tests, specimens collected in the hospital order the test following the date of a which may make them generally less outpatient setting from the OPPS hospital outpatient’s discharge from the tied to a primary service in the hospital packaging policy. In general, hospital outpatient department because outpatient setting than more common commenters urged CMS to finalize a testing on a ‘‘liquid-based’’ specimen is and routine laboratory tests that are policy that focuses on whether the test typically ordered before the specimen is packaged. In the proposed rule, we was performed outside the hospital after collected. These commenters noted that sought public comment on whether the outpatient encounter, rather than on requiring the physician to order the test these tests, by their nature, are the date the specimen was collected or at least 1 day following the date of a appropriately separable from the the date the test was initially ordered. patient’s discharge from the hospital
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outpatient department would exclude a We agree that some of the potential However, to help ensure that only tests blood-based molecular pathology test revisions to the laboratory DOS policy that are not related to the care provided from an exception to the laboratory DOS that we described in the CY 2018 OPPS/ in the hospital fall under this provision, policy. ASC proposed rule may not allow ADLT we will specify that the tests must be • Require that it be ‘‘medically or molecular pathology testing performed following the hospital appropriate’’ to have collected the performed on liquid-based samples to outpatient’s discharge. That is, in order sample during the hospital outpatient qualify for a DOS exception. In for the DOS to be the date the test was encounter. Several commenters noted particular, we recognize that a performed, instead of the date the that it would be medically appropriate requirement that it would be ‘‘medically sample was collected, the test must be for an independent laboratory that is not inappropriate’’ to have collected the performed following a hospital associated with the hospital to collect a specimen from the hospital outpatient outpatient’s discharge from the hospital liquid-based specimen. These other than during the hospital outpatient department. We understand commenters suggested that the potential outpatient encounter is primarily this is standard practice for these types revision to the laboratory DOS policy applicable to tissue-based specimens. It of tests and, therefore, we would not that specified it would be medically would not be applicable to liquid-based expect this provision to change current inappropriate to have collected the samples because it could be medically laboratory practices or have any adverse sample from the hospital outpatient appropriate to collect a liquid-based effect on patient care. other than during the hospital specimen in settings outside of a We note that some of the commenters’ outpatient encounter, applies to tests hospital outpatient encounter, such as suggested modifications to our potential performed on tissue-based samples, but an independent laboratory not DOS revisions are inconsistent with the could inadvertently create incentives for associated with the hospital. As such, current OPPS packaging policy and hospitals to require hospital outpatients we believe use of the term ‘‘medically would result in allowing the laboratory to go elsewhere for liquid-based inappropriate’’ would inappropriately to bill Medicare directly for a test that specimen collection. These commenters exclude laboratory testing performed on is not paid at the CLFS rate but paid also stated that requiring a patient to liquid-based specimens from qualifying under the hospital OPPS bundled rate. travel to a different location for the for the proposed exception to the In the proposed rule (82 FR 33652), we specimen collection could present laboratory DOS policy. Therefore, we specifically discussed creating an access issues for patients with limited believe the revision suggested by the exception to the current DOS policy for mobility. Therefore, these commenters commenters, that is, to specify that it ADLTs approved by CMS under section suggested a modification to the potential ‘‘was medically appropriate to have 1834A(d)(5)(A) of the Act and molecular revised DOS policy to focus on what is collected the sample from the hospital pathology tests because we have already medically appropriate rather than what outpatient during the hospital recognized that these tests may have a is not medically appropriate. To that outpatient encounter,’’ would address different pattern of clinical use than end, these commenters requested that concerns that the DOS exception should more conventional laboratory tests, CMS replace the term ‘‘medically encompass testing performed on liquid- which may make them generally less inappropriate’’ with a requirement that based samples as well as testing tied to a primary service in the hospital it ‘‘was medically appropriate to have performed on tissue-based samples. outpatient setting than the more collected the sample from the hospital common and routine tests that are outpatient during the hospital In addition, we agree with the commenters that requiring the physician packaged. In addition, these tests are outpatient encounter.’’ already paid separately outside of the A few additional commenters to order the test following the date of a hospital outpatient’s discharge from the OPPS at CLFS payment rates. We note suggested regulatory language to modify that laboratory tests granted ADLT the existing laboratory DOS policy in hospital outpatient department (as we described in the proposed rule) could status under section 1834A(d)(5)(B) of accordance with the specific the Act 33 currently are not excluded recommendations discussed previously. also inappropriately exclude tests performed on liquid-based specimens from the OPPS packaging policy. Specifically, these commenters Likewise, GSP testing, PLA tests, and suggested adding a new exception to the from the DOS exception, because a protein-based MAAAs that are not DOS policy so that, in the case of a blood test is typically ordered before the considered molecular pathology tests molecular pathology test or an ADLT sample is collected. We proposed are also conditionally packaged under that meets the criteria of section including the order date requirement for the OPPS at this time. In the proposed 1834A(d)(5) of the Act, or a test that is the same reason we included such a rule, we did not specifically discuss a MAAA, the date of service must be the requirement in the 14-day rule: Because expanding the laboratory tests that may date the test was performed only if: (1) we believe it is more difficult to qualify for a DOS exception beyond the The specimen was collected from a determine that a test ordered before ADLTs and molecular pathology tests hospital outpatient during an encounter discharge is appropriately separable that are currently excluded from OPPS (as both are defined 42 CFR 410.2); (2) from the hospital stay that preceded the packaging, and therefore we are not it was medically appropriate to have test (71 FR 69706). However, as collected the sample from the hospital discussed more fully below, we believe including ADLTs under Criterion (B), outpatient during the hospital the ADLTs and molecular pathology GSP tests, PLA tests, or protein-based outpatient encounter; (3) the results of tests excluded from the OPPS packaging MAAAs in the revised DOS policy at the test do not guide treatment provided policy are, by their nature, tests that are this time. We intend to study this issue during the hospital outpatient used to determine posthospital care, and 33 Under section 1834A(d)(5)(B) of the Act, an encounter; and (4) the test was therefore can be legitimately ADLT is a CDLT covered under Medicare Part B reasonable and medically necessary for distinguished from the care the patient that is offered and furnished only by a single the diagnosis or treatment of an illness receives in the hospital even if they are laboratory and not sold for use by a laboratory other or injury. ordered prior to the patient’s discharge. than the original developing laboratory (or a successor owner) and . . . ‘‘[t]he test is cleared or Response: We appreciate the support Therefore, we do not believe it is approved by the Food and Drug Administration.’’ from commenters for our potential necessary to include an order date CMS has established a regulatory definition for this revisions to the laboratory DOS policy. requirement as part of this exception. type of ADLT in 42 CFR 414.502.
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and, if warranted, consider proposing certain tests that we believe are not hospital for these tests, if all of the changes to the laboratory tests subject to related to the hospital treatment and are conditions are met. a DOS exception in future rulemaking. used to determine posthospital care. We We note that this new exception to As noted previously in this section, believe a similar exception is justified the laboratory DOS policy will not we believe the current laboratory DOS for the molecular pathology tests and apply to tests granted ADLT status by policy creates administrative ADLTs excluded from the OPPS CMS under section 1834A(d)(5)(A) of complexities for hospitals and packaging policy, which we understand the Act and molecular pathology tests laboratories with regard to molecular are used to guide and manage the when performed on a specimen pathology tests and laboratory tests patient’s care after the patient is collected from a hospital inpatient. As expected to be designated by CMS as discharged from the hospital outpatient discussed more fully below, we believe ADLTs that meet the criteria of section department. We believe that, like the adding a laboratory DOS exception for 1834A(d)(5)(A) of the Act. Under the other tests currently subject to DOS hospital inpatients would have policy current laboratory DOS policy, if the exceptions, these tests can legitimately and ratesetting implications under the tests are ordered less than 14 days be distinguished from the care the IPPS diagnosis related group (DRG) following a hospital outpatient’s payment, and we did not solicit patient receives in the hospital, and discharge from the hospital outpatient comments on potential revisions to our thus we would not be unbundling department, laboratories generally current laboratory DOS policy specific services that are appropriately cannot bill Medicare directly for the to the hospital inpatient setting. molecular pathology test or ADLT. In associated with hospital treatment. In order to allow a laboratory to bill those circumstances, the hospital must Moreover, as noted previously, these Medicare directly for an ADLT or bill Medicare for the test, and the tests are already paid separately outside molecular pathology test excluded from laboratory must seek payment from the of the OPPS at CLFS payment rates. the OPPS packaging policy, we are hospital. We have heard from Therefore, we agree with the modifying 42 CFR 414.510(b) by adding commenters that because ADLTs are commenters that the laboratory a new paragraph (5) to establish that, in performed by only a single laboratory performing the test should be permitted the case of a molecular pathology test or and molecular pathology tests are often to bill Medicare directly for these tests, a test designated by CMS as an ADLT performed by only a few laboratories, instead of relying on the hospital to bill under paragraph (1) of the definition of and hospitals may not have the Medicare on behalf of the laboratory advanced diagnostic laboratory test in technical ability to perform these under arrangements. 42 CFR 414.502, the DOS of the test complex tests, the hospital may be For these reasons and in light of the must be the date the test was performed reluctant to bill Medicare for a test it commenters’ suggestions, we are only if— would not typically (or never) perform. revising the current laboratory DOS • The test was performed following a As a result, the hospital might delay policy at 42 CFR 414.510(b) for tests hospital outpatient’s discharge from the ordering the test until at least 14 days granted ADLT status by CMS under hospital outpatient department; • after the patient is discharged from the section 1834A(d)(5)(A) of the Act and The specimen was collected from a hospital outpatient department or even molecular pathology tests that are hospital outpatient during an encounter cancel the order to avoid the DOS (as both are defined in 42 CFR 410.2); excluded from the OPPS packaging • policy, which may restrict a patient’s policy under 42 CFR 419.2(b), so that It was medically appropriate to timely access to these tests. In addition, the performing laboratory may bill and have collected the sample from the we have heard from commenters that be paid by Medicare directly for these hospital outpatient during the hospital the current laboratory DOS policy may tests under the circumstances described outpatient encounter; • The results of the test do not guide disproportionately limit access for below. The revision will provide an treatment provided during the hospital Medicare beneficiaries under original exception to the general laboratory DOS outpatient encounter; and Medicare fee-for-service (that is, rule—that is, the DOS is the date the Medicare Part A and Part B) because • The test was reasonable and specimen was collected—so that the Medicare Advantage plans under medically necessary for the treatment of DOS for these tests is the date the Medicare Part C and other private an illness. laboratory test was performed. This payors allow laboratories to bill directly We intend to continue to study the exception to the current laboratory DOS for tests they perform. laboratory DOS policy and determine We also recognize that greater policy will only apply to tests granted whether any additional changes are consistency between the laboratory DOS ADLT status by CMS under paragraph warranted. In particular, we will rules and the current OPPS packaging (1) of the definition of ‘‘advanced consider whether there should be any policy would be beneficial and would diagnostic laboratory test’’ in 42 CFR changes to the current 14-day rule, address some of the administrative and 414.502, which CMS promulgated to including whether to address any billing issues created by the current implement section 1834A(d)(5)(A) of the inconsistencies with our new exception, DOS policy. As noted previously, we Act, and molecular pathology tests and any changes to the ‘‘under exclude all molecular pathology tests excluded from the OPPS packaging arrangements’’ provisions, including and ADLTs under section policy as defined in 42 CFR 419.2(b). By with respect to the hospital inpatient 1834A(d)(5)(A) of the Act from the adding an exception to the current setting. We expect to propose any future OPPS packaging policy because we laboratory DOS policy at 42 CFR changes to the laboratory DOS policy believe these tests may have a different 414.510(b) for molecular pathology tests through notice-and-comment pattern of clinical use, which may make and ADLTs that are excluded from the rulemaking. them generally less tied to a primary OPPS packaging policy under 42 CFR Comment: A few commenters service in the hospital outpatient setting 419.2(b), the performing laboratory will requested that any changes to the than the more common and routine be required to bill Medicare directly for laboratory DOS policy apply to ADLTs laboratory tests that are packaged. tests that meet this exception. The and molecular pathology tests Under the current DOS policy, we have hospital will no longer bill Medicare for performed on specimens collected from established exceptions that permit the these tests, and the laboratory will no both hospital inpatients and hospital DOS to be the date of performance for longer have to seek payment from the outpatients. These commenters stated
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that it would be an administrative laboratories to track the DOS for ADLTs not necessary to allow a hospital burden on hospitals that collect and molecular pathology tests ordered outreach laboratory to bill Medicare specimens, and laboratories that furnish for hospital outpatients in a way that is separately for the test. and bill for ADLTs and molecular different from those ordered for hospital Comment: One commenter requested pathology tests, to track tests ordered for inpatients. However, because clarification as to whether an exception hospital outpatients in a way that is laboratories will no longer need to seek to the laboratory DOS policy would inconsistent with those performed on payment from the hospital outpatient allow a hospital to continue billing for specimens obtained from hospital department for these tests if all ADLTs or molecular pathology tests inpatients. requirements in new § 414.510(b)(5) are excluded from the OPPS packaging One commenter stated that met, we believe that some of the policy or whether the policy change consistency between the DOS for additional burden mentioned by the would require a laboratory to bill hospital inpatients and hospital commenters is likely to be offset by the Medicare directly for these tests. outpatients is important for evaluating revised DOS policy. With regard to the Another commenter recommended that data on patient outcomes. For example, comments on evaluating data on patient any change to laboratory DOS policy or the commenter noted that laboratory outcomes, we note that, in the CY 2018 the ‘‘under arrangements’’ provisions tests ordered for hospital inpatients do OPPS/ASC proposed rule, we focused should allow either the hospital or the not have the tests’ HCPCS code(s) on the only on potential revisions to the laboratory that performed the test to bill inpatient claim. As a result, CMS cannot laboratory DOS policy for Criterion (A) the Medicare program directly. The track patients who have received these ADLTs and molecular pathology tests commenter indicated that, in some tests using claims data, or evaluate how excluded from the OPPS packaging circumstances, other laboratory tests in advanced testing contributes to cancer policy that are performed on a specimen addition to ADLTs and or molecular care and other advanced treatments, or collected from a hospital outpatient pathology tests are ordered following evaluate the total cost of care. To that during a hospital outpatient encounter the patient’s discharge from the hospital end, a few commenters suggested that to enable the laboratory to bill Medicare outpatient department and that it may CMS use coding modifiers to identify directly for those tests. We did not be less of a burden on the laboratory to ADLTs and molecular pathology tests discuss revising the laboratory DOS allow the hospital to bill for all that do not guide treatment during an policy to improve CMS’ ability to laboratory tests ordered rather than inpatient hospital stay so that separate evaluate patient outcomes. As noted require some tests to be billed by the payment can be made at the HCPCS previously, we intend to continue hospital and other tests to be billed by code level for these laboratory tests. studying this issue and, if warranted, the laboratory. In contrast to the commenters consider changes to the laboratory DOS Response: If a test meets all suggesting a laboratory DOS revision for policy for laboratory tests performed on requirements for the new exception to both hospital outpatients and hospital specimens collected during an inpatient the DOS policy in § 414.510(b)(5), the inpatients, one commenter requested hospital stay in future rulemaking. DOS of the test must be the date the test that CMS limit revisions to the Comment: A few commenters was performed, which means the laboratory DOS policy to outpatient suggested that any changes to the DOS laboratory performing the test must bill laboratory tests that are excluded from rule also apply to ‘‘referred nonpatient Medicare for the test. The hospital the OPPS packaging policy and specimens.’’ The commenters explained would no longer be permitted to bill for separately payable at CLFS rates that hospitals receive tissue and/or these tests unless the hospital laboratory because it would merely change which blood samples for testing from actually performed the test. That is, if entity bills for the laboratory test. The physician’s offices or other locations in the hospital laboratory performed the commenter noted that because all circumstances in which no hospital ADLT or molecular pathology test, the laboratory testing ordered on specimens encounter occurs. The commenters hospital laboratory would bill Medicare obtained from hospital inpatients less recommended that CMS allow this type for the test. We believe the potential than 14 days after discharge are of testing to be billed separately and not administrative burden on the laboratory currently bundled into the hospital IPPS be required to be billed with other to bill for some of the tests performed rates, a change in the laboratory DOS outpatient hospital services. on a specimen collected from a hospital policy for hospital inpatients would Response: In the situation described outpatient during a hospital outpatient entail many other policy changes. by the commenters, the laboratory encounter will be offset, to some degree, Response: As discussed previously, would be performing the test as a because the laboratory would no longer we believe an exception to the DOS hospital outreach laboratory. A hospital need to seek payment from the hospital policy that is limited to the hospital outreach laboratory is a hospital-based outpatient department for those tests, if outpatient setting is warranted for laboratory that furnishes laboratory tests all requirements in § 414.510(b)(5) are Criterion (A) ADLTs and molecular to patients who are not admitted met. pathology tests excluded from the OPPS hospital inpatients or registered Comment: A few commenters packaging policy because these tests are outpatients of the hospital. As discussed requested that CMS clarify that the date already paid at CLFS rates and not paid previously, the new exception to the of performance is the date of a under the OPPS, among other reasons. laboratory DOS policy will apply to laboratory’s final report. They suggested We did not discuss or propose an tests granted ADLT status under this clarification would avoid any analogous DOS exception for tests Criterion (A) by CMS and molecular ambiguity regarding the date of performed on specimens collected from pathology tests excluded from the OPPS performance of the test. One commenter hospital inpatients in the CY 2018 packaging policy that are performed on urged CMS to define the DOS as the OPPS/ASC proposed rule, and we agree a specimen collected from a hospital date of final report for all laboratory with the commenter who stated that outpatient during a hospital outpatient tests. such an exception would have broader encounter. Because hospital outreach Response: We considered the policy implications for the IPPS that laboratories perform laboratory tests on commenters’ suggestion to use the date need to be carefully considered. We specimens collected from beneficiaries of final report as the DOS for ADLTs acknowledge that there could be an who are not patients of the hospital, a and molecular pathology tests excluded administrative burden for hospitals and revision to the laboratory DOS policy is from the OPPS packaging policy that are
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performed on a specimen collected from arrangement with the single laboratory is billing for the test is located in a a hospital outpatient during a hospital that furnishes a particular ADLT, which different MAC jurisdiction from the outpatient encounter. However, we have could lead the hospital to delay the laboratory, and the MAC processing concerns with this approach because we order for the ADLT until 14 days after claims for the jurisdiction in which the believe there is no clear and consistent the patient’s discharge to avoid financial hospital is located has not made a definition of ‘‘final report’’ that applies risk and thus potentially delay coverage determination for the test. to all laboratories and all types of medically necessary care for the A few other commenters explained specimens collected; that is, liquid- beneficiary. that molecular pathology tests are based, cellular, or tissue samples. We stated in the proposed rule that important tools that guide patient Regarding the comment requesting a we believe the circumstances may be treatment plans and that many hospitals revision to the DOS policy for all different for molecular pathology tests, currently lack the in-house technical laboratory tests, we note that we focused which are not required to be furnished expertise and Clinical Laboratory on potential revisions regarding by a single laboratory. In particular, we Criterion (A) ADLTs and molecular understood there may be ‘‘kits’’ for Improvement Amendments (CLIA) pathology tests excluded from the OPPS certain molecular pathology tests that a licensure to perform these tests and, packaging policy in the CY 2018 OPPS/ hospital can purchase, allowing the therefore, send them out to a performing ASC proposed rule, and did not discuss hospital to perform the test. Therefore, laboratory. The commenters noted that potential revisions to the DOS policy for we stated that molecular pathology tests molecular pathology ‘‘kits’’ (as all laboratory tests. may not present the same concerns of referenced by CMS in the CY 2018 Comment: A few commenters delayed access to medically necessary OPPS/ASC proposed rule) are different requested that CMS modify the 14-day care as ADLTs, which must be from those used for other CDLTs. For rule requirement for all laboratory tests performed by a single laboratory. example, the commenters explained that because it is operationally complicated Thus, in the proposed rule, we molecular pathology test kits require the and may result in delays in testing until requested specific comments on hospital to have the highest licensure after the 14-day window has passed. potentially creating an exception to the level under CLIA, as well as obtain Response: As discussed previously in DOS policy that is limited to ADLTs specialized training for correct use and this section, the discussion in the CY that meet the criteria in section interpretation of the results, and that 2018 OPPS/ASC proposed rule was 1834A(d)(5)(A) of the Act and have been most hospitals are unlikely to have primarily focused on potential granted ADLT status by CMS. We also either the expertise or the technology to modifications to the DOS policy for requested public comments on how the use these kits. To ensure appropriate Criterion (A) ADLTs and molecular current laboratory DOS policy may access to molecular pathology tests by pathology tests excluded from the OPPS affect billing for other separately rural and community hospitals, as well packaging policy. We did not address payable laboratory test codes that are as academic and specialty hospitals, the potential modifications to the DOS not packaged under the OPPS, such as commenters requested that the revisions policy that would apply to all laboratory a laboratory test that is the only service to the current laboratory DOS policy tests, so we will not make such changes provided to a beneficiary on a claim or apply to both ADLTs and molecular in this rule. However, as noted molecular pathology tests. pathology tests. previously, we intend to continue Comment: Many commenters Response: We agree with commenters studying this issue and, if warranted, supported revising the current that limiting the new laboratory DOS will consider proposing further changes laboratory DOS policy for both Criterion exception to include only ADLTs (and to the DOS policy in future rulemaking. (A) ADLTs and molecular pathology tests. They did not support an exception not molecular pathology tests) would be (a) Limiting the DOS Rule Exception to to the current laboratory DOS policy inconsistent with the OPPS packaging ADLTs that would be limited only to ADLTs policy, which currently excludes tests In the CY 2018 OPPS/ASC proposed that meet the criteria in section granted ADLT status by CMS under rule (82 FR 33653), we also indicated 1834A(d)(5)(A) of the Act and have been section 1834A(d)(5)(A) of the Act and that we were considering potentially granted ADLT status by CMS (and molecular pathology tests. As noted by revising the DOS rule to create an therefore exclude molecular pathology the commenters, relatively few exception only for ADLTs that meet the tests from the DOS exception). Several laboratories may perform certain criteria in section 1834A(d)(5)(A) of the commenters noted that creating an molecular pathology testing. We also Act. This exception would not cover exception for only ADLTs would not be acknowledge that hospitals may not molecular pathology tests. We stated consistent with current OPPS packaging have the technical expertise or that we were considering this approach policy, which excludes both Criterion certification requirements necessary to because ADLTs approved by CMS under (A) ADLTs and molecular pathology perform molecular pathology testing Criterion (A), like all ADLTs, are offered tests. and therefore must rely on independent and furnished only by a single In addition, a few commenters laboratories to perform the test. laboratory (as defined in 42 CFR indicated that beneficiary access issues Therefore, we believe similar 414.502). The hospital, or another similar to those for ADLTs, which are beneficiary access concerns that apply laboratory, that is not the single furnished by a single laboratory, may to ADLTs may also apply to molecular laboratory (as defined in 42 CFR also exist for molecular pathology tests pathology tests. As indicated 414.502), cannot furnish the ADLT. because molecular pathology testing is previously, after consideration of the Therefore, we noted in the proposed highly specialized and may be public comments received on this issue, rule that there may be additional performed by only a few laboratories. in this final rule with comment period, beneficiary access concerns for these The commenters also noted that a we are revising the current laboratory ADLTs that may not apply to molecular coverage policy for a given molecular DOS policy to create a new exception pathology tests, and that could be pathology test may have only been for tests granted ADLT status by CMS addressed by allowing the laboratories issued by a MAC in the jurisdiction in under Criterion (A) and molecular to bill Medicare directly for these tests. which the laboratory is located. This pathology tests excluded from the OPPS For example, a hospital may not have an could be problematic if the hospital that packaging policy.
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(b) Other Alternative Approaches and all MAAAs, irrespective of whether XI. CY 2018 OPPS Payment Status and Finally, in the CY 2018 OPPS/ASC these tests are currently excluded from Comment Indicators proposed rule (82 FR 33653), we invited the OPPS packaging policy. A. CY 2018 OPPS Payment Status public comments on alternative Response: We appreciate the feedback Indicator Definitions approaches to addressing stakeholders’ that commenters provided in response Payment status indicators (SIs) that concerns regarding the DOS policy, to our request for comments on we assign to HCPCS codes and APCs such as potentially modifying the potential modifications to the ‘‘under serve an important role in determining ‘‘under arrangements’’ provisions in 42 arrangements’’ provisions. As discussed payment for services under the OPPS. CFR 410.42 and 411.15(m). Specifically, previously, in this final rule with They indicate whether a service we requested comments on whether an comment period, we are finalizing a represented by a HCPCS code is payable exception should be added to revision to the current laboratory DOS under the OPPS or another payment § 410.42(b) and/or § 411.15(m)(3) for policy so that laboratories performing system and also whether particular molecular pathology tests and ADLTs Criterion (A) ADLTs and molecular OPPS policies apply to the code. that are excluded from the OPPS pathology tests excluded from the OPPS In the CY 2018 OPPS/ASC proposed packaging policy under 42 CFR 419.2(b) packaging policy can bill Medicare rule (82 FR 33653), for CY 2018, we did and how such an exception should be directly for those tests, instead of not propose to make any changes to the framed. seeking payment from the hospital definitions of status indicators that were Comment: Several commenters listed in Addendum D1 to the CY 2017 preferred modifications to the ‘‘under outpatient department. We believe including this revision as part of OPPS/ASC final rule with comment arrangements’’ provisions to a period available on the CMS Web site at: laboratory DOS revision. They stated § 414.510 is more consistent with how we have historically addressed https://www.cms.gov/Medicare/ that modifying the ‘‘under Medicare-Fee-for-Service-Payment/ laboratory DOS issues and, at this stage, arrangements’’ provisions could be a HospitalOutpatientPPS/Hospital- is the appropriate way to address more direct approach for permitting a Outpatient-Regulations-and-Notices- stakeholders’ administrative and billing performing laboratory to bill Medicare Items/CMS-1656-FC.html?DLPage=1& directly for ADLTs and molecular concerns regarding these tests. As noted DLEntries=10&DLSort=2& pathology tests. Therefore, the previously, we intend to continue to DLSortDir=descending. commenters requested that CMS add study this issue and specifically We requested public comments on the another exception to the ‘‘under consider whether further revisions to proposed definitions of the OPPS status arrangements’’ provisions so that a the ‘‘under arrangements’’ provisions indicators for CY 2018. We did not revision to the laboratory DOS policy are warranted. If we believe revisions to receive any public comments. We would not be necessary. They suggested the ‘‘under arrangements’’ provisions believe that the existing CY 2017 that changes to the ‘‘under may be warranted, we expect we would definitions of the OPPS status indicators arrangements’’ provisions could be propose those changes through notice- continue to be appropriate for CY 2018. made in lieu of modifying the laboratory and-comment rulemaking. Therefore, we are finalizing our DOS rules and asserted that this In summary, after considering the proposed CY 2018 definitions of the approach would only revise the ‘‘billing OPPS status indicators without regulation’’ for tests performed on public comments we received, we are adding an additional exception to our modifications. hospital outpatient specimens to align The complete list of the payment with CMS’ existing exclusions from the current laboratory DOS regulations at status indicators and their definitions OPPS packaging policy. § 414.510(b)(5) so that the DOS for that apply for CY 2018 is displayed in In addition, a few commenters noted molecular pathology tests and tests Addendum D1 to this final rule with that certain practitioner services, such designated by CMS as Criterion (A) comment period, which is available on as physician services and nurse ADLTs is the date the test was the CMS Web site at: https:// practitioner services, are not performed performed only if: (1) The test was www.cms.gov/Medicare/Medicare-Fee- by the hospital outpatient department performed following a hospital for-Service-Payment/Hospital and paid under a separate fee schedule, outpatient’s discharge from the hospital OutpatientPPS/index.html. and therefore, are currently excluded outpatient department; (2) the specimen The CY 2018 payment status indicator from the ‘‘under arrangements’’ was collected from a hospital outpatient assignments for APCs and HCPCS codes provisions. They contended that adding during an encounter (as both are defined are shown in Addendum A and an exception to the ‘‘under in § 410.2); (3) it was medically Addendum B, respectively, to this final arrangements’’ provisions for appropriate to have collected the sample rule with comment period, which are nonpackaged laboratory tests which are from the hospital outpatient during the available on the CMS Web site at: paid at the CLFS rates would be hospital outpatient encounter; (4) the https://www.cms.gov/Medicare/ consistent with the exceptions for other results of the test do not guide treatment Medicare-Fee-for-Service-Payment/ services (for example, physician provided during the hospital outpatient HospitalOutpatientPPS/index.html. services) paid separately from the encounter; and (5) the test was hospital service. B. CY 2018 Comment Indicator A few commenters also provided reasonable and medically necessary for Definitions specific recommendations on how CMS the treatment of an illness. This new In the CY 2018 OPPS/ASC proposed should revise the ‘‘under arrangements’’ exception to the laboratory DOS policy rule (82 FR 33654), we proposed to use regulations at §§ 410.42(b) and will enable laboratories performing four comment indicators for the CY 411.15(m). Similar to their Criterion (A) ADLTs and molecular 2018 OPPS. These comment indicators, recommendations for revising the pathology tests excluded from the OPPS ‘‘CH’’, ‘‘NC’’, ‘‘NI’’, and ‘‘NP’’, are in laboratory DOS policy, the commenters packaging policy to bill Medicare effect for CY 2017 and we proposed to suggested adding an exception to the directly for those tests, instead of continue their use in CY 2018. The ‘‘under arrangements’’ provisions for requiring them to seek payment from proposed CY 2018 OPPS comment molecular pathology tests, all ADLTs, the hospital outpatient department. indicators are as follows:
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• ‘‘CH’’—Active HCPCS code in 74379; 77 FR 68434 through 68467; 78 tests within the medicine range of CPT current and next calendar year, status FR 75064 through 75090; 79 FR 66915 codes for which separate payment is indicator and/or APC assignment has through 66940; 80 FR 70474 through allowed under the OPPS when they are changed; or active HCPCS code that will 70502; and 81 FR 79732 through 79753, provided integral to an ASC covered be discontinued at the end of the respectively). surgical procedure. Covered ancillary current calendar year. services are specified in § 416.164(b) 2. Policies Governing Changes to the • ‘‘NC’’—New code for the next and, as stated previously, are eligible for Lists of Codes and Payment Rates for calendar year or existing code with separate ASC payment. Payment for ASC Covered Surgical Procedures and substantial revision to its code ancillary items and services that are not Covered Ancillary Services descriptor in the next calendar year as paid separately under the ASC payment compared to current calendar year for Under 42 CFR 416.2 and 416.166 of system is packaged into the ASC which we requested comments in the the Medicare regulations, subject to payment for the covered surgical proposed rule, final APC assignment; certain exclusions, covered surgical procedure. comments will not be accepted on the procedures in an ASC are surgical We update the lists of, and payment final APC assignment for the new code. procedures that are separately paid rates for, covered surgical procedures • ‘‘NI’’—New code for the next under the OPPS, that would not be and covered ancillary services in ASCs calendar year or existing code with expected to pose a significant risk to in conjunction with the annual substantial revision to its code beneficiary safety when performed in an proposed and final rulemaking process descriptor in the next calendar year as ASC, and for which standard medical to update the OPPS and the ASC compared to current calendar year, practice dictates that the beneficiary payment system (§ 416.173; 72 FR interim APC assignment; comments will would not typically be expected to 42535). We base ASC payment and be accepted on the interim APC require active medical monitoring and policies for most covered surgical assignment for the new code. care at midnight following the procedures, drugs, biologicals, and • ‘‘NP’’—New code for the next procedure (‘‘overnight stay’’). We certain other covered ancillary services calendar year or existing code with adopted this standard for defining on the OPPS payment policies, and we substantial revision to its code which surgical procedures are covered use quarterly change requests (CRs) to descriptor in the next calendar year as under the ASC payment system as an update services covered under the compared to current calendar year, indicator of the complexity of the OPPS. We also provide quarterly update proposed APC assignment; comments procedure and its appropriateness for CRs for ASC covered surgical will be accepted on the proposed APC Medicare payment in ASCs. We use this procedures and covered ancillary assignment for the new code. standard only for purposes of evaluating services throughout the year (January, We requested public comments on procedures to determine whether or not April, July, and October). We release our proposed use of comment indicators they are appropriate to be furnished to new and revised Level II HCPCS codes for CY 2018. We did not receive any Medicare beneficiaries in ASCs. We and recognize the release of new and public comments. We believe that the define surgical procedures as those revised CPT codes by the AMA and CY 2017 definitions of the OPPS described by Category I CPT codes in make these codes effective (that is, the comment indicators continue to be the surgical range from 10000 through codes are recognized on Medicare appropriate for CY 2018. Therefore, we 69999 as well as those Category III CPT claims) via these ASC quarterly update are continuing to use those definitions codes and Level II HCPCS codes that CRs. We recognize the release of new without modification for CY 2018. directly crosswalk or are clinically and revised Category III CPT codes in The definitions of the final OPPS similar to procedures in the CPT the July and January CRs. These updates comment indicators for CY 2018 are surgical range that we have determined implement newly created and revised listed in Addendum D2 to this final rule do not pose a significant safety risk, that Level II HCPCS and Category III CPT with comment period, which is we would not expect to require an codes for ASC payments and update the available on the CMS Web site at: overnight stay when performed in ASCs, payment rates for separately paid drugs https://www.cms.gov/Medicare/ and that are separately paid under the and biologicals based on the most Medicare-Fee-for-Service-Payment/ OPPS (72 FR 42478). recently submitted ASP data. New and HospitalOutpatientPPS/index.html. In the August 2, 2007 final rule (72 FR revised Category I CPT codes, except 42495), we also established our policy vaccine codes, are released only once a XII. Updates to the Ambulatory to make separate ASC payments for the year, and are implemented only through Surgical Center (ASC) Payment System following ancillary items and services the January quarterly CR update. New A. Background when they are provided integral to ASC and revised Category I CPT vaccine covered surgical procedures: (1) codes are released twice a year and are 1. Legislative History, Statutory Brachytherapy sources; (2) certain implemented through the January and Authority, and Prior Rulemaking for the implantable items that have pass- July quarterly CR updates. We refer ASC Payment System through payment status under the readers to Table 41 in the CY 2012 For a detailed discussion of the OPPS; (3) certain items and services that OPPS/ASC proposed rule for an legislative history and statutory we designate as contractor-priced, example of how this process, which we authority related to payments to ASCs including, but not limited to, finalized in the CY 2012 OPPS/ASC under Medicare, we refer readers to the procurement of corneal tissue; (4) final rule with comment period, is used CY 2012 OPPS/ASC final rule with certain drugs and biologicals for which to update HCPCS and CPT codes (76 FR comment period (76 FR 74377 through separate payment is allowed under the 42291; 76 FR 74380 through 74381). 74378) and the June 12, 1998 proposed OPPS; and (5) certain radiology services In our annual updates to the ASC list rule (63 FR 32291 through 32292). For for which separate payment is allowed of, and payment rates for, covered a discussion of prior rulemaking on the under the OPPS. In the CY 2015 OPPS/ surgical procedures and covered ASC payment system, we refer readers ASC final rule with comment period (79 ancillary services, we undertake a to the CYs 2012, 2013, 2014, 2015, 2016, FR 66932 through 66934), we expanded review of excluded surgical procedures and 2017 OPPS/ASC final rules with the scope of ASC covered ancillary (including all procedures newly comment period (76 FR 74378 through services to include certain diagnostic proposed for removal from the OPPS
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inpatient list), new codes, and codes procedures. For example, these revising the definition could further with revised descriptors, to identify any stakeholders stated that certain cardiac stress hospitals in isolated rural care that we believe meet the criteria for catheterization services, cardiac device settings because many ASCs are located designation as ASC covered surgical programming services, and in rural areas. procedures or covered ancillary electrophysiology services should be Other commenters suggested that services. Updating the lists of ASC added to the covered surgical CMS develop and solicit comments on covered surgical procedures and procedures list. While we continue to a clear definition and criteria for covered ancillary services, as well as believe that using the CPT code range to surgical site selection. Commenters also their payment rates, in association with define surgery represents a logical, suggested patient selection and risk the annual OPPS rulemaking cycle is appropriate, and straightforward stratification protocols that would particularly important because the approach to defining a surgical harmonize the different criteria of OPPS relative payment weights and, in procedure, we also believe it may be hospital outpatient departments and some cases, payment rates, are used as appropriate for us to use the CPT ASCs. In addition, they recommended the basis for the payment of many surgical range as a guide rather than a that further clinical evaluation of the covered surgical procedures and requirement as to whether a procedure consequences to the Medicare covered ancillary services under the is surgical, which would give us more population be performed before revising revised ASC payment system. This joint flexibility to include ‘‘surgery-like’’ the definition of ASC covered surgical update process ensures that the ASC procedures on the ASC Covered procedures. updates occur in a regular, predictable, Procedures List (CPL). We are cognizant Many commenters supported revising and timely manner. of the dynamic nature of ambulatory the definition of ASC covered surgical surgery and the continued shift of procedures. Commenters supporting the 3. Definition of ASC Covered Surgical revision of the definition of ASC Procedures services from the inpatient setting to the outpatient setting over the past decade. covered surgical procedures suggested Since the implementation of the ASC Therefore, in the CY 2018 OPPS/ASC that the CPT surgical code range prospective payment system, we have proposed rule (82 FR 33655), we (10000–69999) has not properly defined a ‘‘surgical’’ procedure under solicited public comments regarding accounted for technical advances in the payment system as any procedure services that are described by Category treatment and does not include invasive described within the range of Category I CPT codes outside of the surgical procedures that do not pose a significant I CPT codes that the CPT Editorial Panel range, or Level II HCPCS codes or safety risk, do not require an overnight of the American Medical Association Category III CPT codes that do not stay for Medicare patients, and would (AMA) defines as ‘‘surgery’’ (CPT codes directly crosswalk and are not clinically otherwise be appropriate procedures to 10000 through 69999) (72 FR 42478). be added to the ASC list of covered similar to procedures in the CPT We also have included as ‘‘surgical,’’ surgical procedures. For example, some surgical range, but that nonetheless may procedures that are described by Level commenters believed that several be appropriate to include as covered II HCPCS codes or by Category III CPT catheter-based procedures would be surgical procedures that are payable codes that directly crosswalk or are appropriately performed in the ASC when furnished in the ASC setting. In clinically similar to procedures in the setting. Further, commenters stated that particular, we stated our interest in the CPT surgical range that we have CMS has relied on alternative public’s views regarding additional determined do not pose a significant definitions of a surgical procedure in criteria we might use to consider when safety risk, would not expect to require other operations of the Medicare a procedure that is surgery-like could be an overnight stay when performed in an program that are broader than the ASC, and are separately paid under the included on the ASC CPL. We requested current definition of an ASC covered OPPS (72 FR 42478). that commenters on this issue take into surgical procedure. As we noted in the CY 2008 final rule consideration whether each individual Response: We appreciate the feedback that implemented the revised ASC procedure can be safely and we received from commenters. We payment system, using this definition of appropriately performed in an ASC, as acknowledge the importance of having surgery would exclude from ASC required by the regulations at 42 CFR clear criteria for covered surgical payment certain invasive, ‘‘surgery-like’’ 416.166 (including that standard procedures that account for advances in procedures, such as cardiac medical practice dictates that the surgical treatment in an ASC setting that catheterization or certain radiation beneficiary would not typically be also do not expose Medicare patients to treatment services that are assigned expected to require active medical significant safety risks. In the CY 2018 codes outside the CPT surgical range (72 monitoring and care at midnight OPPS/ASC proposed rule (82 FR 33654 FR 42477). We stated in that final rule following the procedure), and whether through 33655), we did not propose any that we believed continuing to rely on the procedure requires the resources, revisions to our current definition of the CPT definition of surgery is staff, and equipment typical of an ASC. ASC covered surgical procedures. For administratively straightforward, is We also indicated that we were CY 2018, we will continue to define logically related to the categorization of interested in the public’s views on ‘‘surgical’’ procedures under the services by physician experts who both whether and how, if we were to include payment system as those procedures establish the codes and perform the such services as ASC covered surgical described by Category I CPT codes procedures, and is consistent with a procedures, we would need to revise within the range the CPT Editorial Panel policy to allow ASC payment for all our definition of ASC covered surgical of the AMA defines as ‘‘surgery’’ (CPT outpatient surgical procedures (72 FR procedures. codes 10000 through 69999), or Level II 42477). Comment: Some commenters HCPCS codes or Category III CPT codes Recently, some stakeholders have suggested that revising the definition of that directly crosswalk or are clinically suggested that certain procedures that ASC covered surgical procedures would similar to procedures in the CPT are outside the CPT surgical range but inappropriately move procedures from a surgical range that we have determined that are similar to surgical procedures hospital setting to an ASC setting and do not pose a significant safety risk, currently covered in an ASC setting place Medicare patients in greater risk. would not be expected to require an should be ASC covered surgical Some commenters also suggested that overnight stay when performed in an
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ASC, and are separately paid under the make preliminary determinations (and responding to those comments in OPPS. However, we will take these during the annual OPPS/ASC the CY 2019 OPPS/ASC final rule with comments into consideration in future rulemaking process regarding whether comment period). rulemaking. or not they meet the criteria for payment We note that we sought public in the ASC setting as covered surgical B. Treatment of New and Revised Codes comments in the CY 2017 OPPS/ASC procedures and, if so, whether or not final rule with comment period (81 FR 1. Background on Current Process for they are office-based procedures. In 79735 through 79736) on the new and Recognizing New and Revised Category addition, we identify new and revised revised Level II HCPCS codes effective I and Category III CPT Codes and Level codes as ASC covered ancillary services October 1, 2016, or January 1, 2017. II HCPCS Codes based upon the final payment policies These new and revised codes, with an of the revised ASC payment system. In Category I CPT, Category III CPT, and effective date of October 1, 2016, or prior rulemakings, we refer to this Level II HCPCS codes are used to report January 1, 2017, were flagged with process as recognizing new codes. procedures, services, items, and comment indicator ‘‘NI’’ in Addenda However, this process has always supplies under the ASC payment AA and BB to the CY 2017 OPPS/ASC involved the recognition of new and system. Specifically, we recognize the final rule with comment period to revised codes. We consider revised following codes on ASC claims: indicate that we were assigning them an • codes to be new when they have Category I CPT codes, which interim payment status and payment describe surgical procedures and substantial revision to their code descriptors that necessitate a change in rate, if applicable, which were subject to vaccine codes; public comment following publication • Category III CPT codes, which the current ASC payment indicator. To of the CY 2017 OPPS/ASC final rule describe new and emerging clarify, we refer to these codes as new with comment period. We are technologies, services, and procedures; and revised in this CY 2018 OPPS/ASC responding to public comments and and final rule with comment period. • Level II HCPCS codes, which are We have separated our discussion finalize the treatment of these codes used primarily to identify items, below based on when the codes are under the ASC payment system in this supplies, temporary procedures, and released and whether we propose to CY 2018 OPPS/ASC final rule with services not described by CPT codes. solicit public comments in the CY 2018 comment period. We finalized a policy in the August 2, OPPS/ASC proposed rule (and respond In Table 79 below, we summarize our 2007 final rule (72 FR 42533 through to those comments in the CY 2018 process for updating codes through our 42535) to evaluate each year all new and OPPS/ASC final rule with comment ASC quarterly update CRs, seeking revised Category I and Category III CPT period) or whether we are soliciting public comments, and finalizing the codes and Level II HCPCS codes that public comments in this CY 2018 OPPS/ treatment of these new codes under the describe surgical procedures, and to ASC final rule with comment period OPPS.
TABLE 79—COMMENT AND FINALIZATION TIMEFRAMES FOR NEW OR REVISED HCPCS CODES
ASC quarterly Effective Comments update CR Type of code date sought When finalized
April 1, 2017 .. Level II HCPCS Codes ...... April 1, 2017 .. CY 2018 OPPS/ASC proposed CY 2018 OPPS/ASC final rule with rule. comment period. July 1, 2017 ... Level II HCPCS Codes ...... July 1, 2017 ... CY 2018 OPPS/ASC proposed CY 2018 OPPS/ASC final rule with rule. comment perio. Category I (certain vaccine codes) July 1, 2017... CY 2018 OPPS/ASC proposed CY 2018 OPPS/ASC final rule with and III CPT codes. rule. comment period. October 1, Level II HCPCS Codes ...... October 1, CY 2018 OPPS/ASC final rule with CY 2019 OPPS/ASC final rule with 2017. 2017. comment period. comment period. January 1, Level II HCPCS Codes ...... January 1, CY 2018 OPPS/ASC final rule with CY 2019 OPPS/ASC final rule with 2018. 2018. comment period. comment period. Category I and III CPT Codes ...... January 1, CY 2018 OPPS/ASC proposed CY 2018 OPPS/ASC final rule with 2018. rule. comment period. Note: In the CY 2015 OPPS/ASC final rule with comment period (79 FR 66841 through 66844), we finalized a revised process of assigning APC and status indicators for new and revised Category I and III CPT codes that would be effective January 1. We refer readers to section III.A.3. of this CY 2018 OPPS/ASC final rule with comment period for further discussion of this issue.
2. Treatment of New and Revised Level along with their payment indicators for We did not receive any public II HCPCS Codes Implemented in April CY 2018. comments regarding the proposed ASC 2017 for Which We Solicited Public We invited public comments on these payment indicators and payment rates. Comments in the CY 2018 OPPS/ASC proposed payment indicators and the Therefore, we are adopting as final the Proposed Rule proposed payment rates for the new CY 2018 proposed payment indicators Level II HCPCS codes that were for these codes, as indicated in Table 80. In the April 2017 ASC quarterly recognized as ASC covered ancillary We note that several of the HCPCS C- update (Transmittal 3726, CR 9998, services in April 2017 through the codes have been replaced with HCPCS dated March 03, 2017), we added six quarterly update CRs, as listed in Table J-codes, effective January 1, 2018. Their new drug and biological Level II HCPCS 31 of the proposed rule. We proposed to replacement codes are listed in Table codes to the list of covered ancillary finalize their payment indicators and 80. The final payment rates for these services. Table 31 of the proposed rule their payment rates in the CY 2018 codes can be found in Addendum BB to listed the new Level II HCPCS codes OPPS/ASC final rule with comment this final rule with comment period that were implemented April 1, 2017, period. (which is available via the Internet on
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the CMS Web site). In addition, the found in Addendum DD1 to this final available via the Internet on the CMS payment indicator meanings can be rule with comment period (which is Web site).
TABLE 80—NEW LEVEL II HCPCS CODES FOR COVERED ANCILLARY SERVICES EFFECTIVE ON APRIL 1, 2017
CY 2018 CY 2017 CY 2018 CY 2018 Payment HCPCS Code HCPCS Code Long descriptor indicator
C9484 ...... J1428 ...... Injection, eteplirsen, 10 mg ...... K2 C9485 ...... J9285 ...... Injection, olaratumab, 10 mg ...... K2 C9486 ...... J1627 ...... Injection, granisetron extended release, 0.1 mg ...... K2 C9487 * ...... J3358 ...... Ustekinumab, for intravenous injection, 1 mg ...... K2 C9488 ...... C9488 ...... Injection, conivaptan hydrochloride, 1 mg ...... K2 J7328 ...... J7328 ...... Hyaluronan or derivative, gelsyn-3, for intra-articular injection, 0.1 mg ...... K2 * HCPCS code C9487, which was effective April 1, 2017, was deleted June 30, 2017 and replaced with HCPCS code Q9989 (Ustekinumab, for intravenous injection, 1 mg) effective July 1, 2017 through December 31, 2017.
3. Treatment of New and Revised Level quarterly update CRs, as listed in Tables incorrectly reflected a price for HCPCS II HCPCS Codes Implemented in July 32 and 33 of the proposed rule. We code Q9986 based on a 1 mg dose rather 2017 for Which We Solicited Public proposed to finalize their payment than the revised 10 mg dose descriptor. Comments in the CY 2018 OPPS/ASC indicators and their payment rates in We intend to correct the price for Proposed Rule the CY 2018 OPPS/ASC final rule with HCPCS code Q9986 retroactive to July 1, In the July 2017 ASC quarterly update comment period. 2017, in the respective January 2018 (Transmittal 3792, CR 10138, dated June Comment: One commenter supported updates to the OPPS and ASC payment 9, 2017), we added seven new Level II the assignment of HCPCS code Q9986 systems. Applicable program HCPCS codes to the list of covered (Injection, hydroxyprogesterone instructions will be posted to the CMS surgical procedures and ancillary caproate (Makena), 10 mg) to payment Web site at: https://www.cms.gov/ services. Table 32 of the proposed rule indicator ‘‘K2’’. However, the Regulations-and-Guidance/Guidance/ listed the new Level II HCPCS codes commenter requested that CMS review Transmittals/2017-Transmittals.html. that are effective July 1, 2017. The the calculated payment rate for the new After consideration of the public proposed payment rates, where HCPCS code Q9986, as it appeared to comment we received, we are finalizing applicable, for these July codes were the commenter to be inaccurate. The the proposed payment indicators for the included in Addendum BB to the commenter pointed out the following: new Category III CPT code and Level II proposed rule (which is available via The July 2017 OPPS and ASC Update HCPCS codes that were newly the Internet on the CMS Web site). indicates that this new HCPCS code is recognized as ASC covered surgical Through the July 2017 quarterly ‘‘per 10 mg’’ with a payment rate of procedures or covered ancillary services update CR, we also implemented ASC $2.72 (as indicated in the July 2017 in July 2017 through the quarterly payment for one new Category III CPT Addendum B/BB and in Addendum B update CRs, as indicated in Table 81 code as an ASC covered surgical and Addendum BB to the CY 2018 below. We note that several of the procedure, effective July 1, 2017. This OPPS/ASC proposed rule). Prior to July HCPCS C- and Q-codes have been code was listed in Table 33 of the 1, 2017, Makena® (NDC #64011–0247– replaced with HCPCS J-codes, effective proposed rule, along with its proposed 02 and NDC #64011–0243–01) was January 1, 2018. Their replacement payment indicator. The proposed reported under HCPCS code J1725, codes are listed in Table 81 below. The payment rate for this new Category III which had a dose and measure of ‘‘per CY 2018 final payment rates, where CPT code was included in Addendum 1 mg’’ and a payment rate of $2.74 applicable, for these July codes can be AA to the proposed rule (which is (April 2017 Addendum B/BB). Makena® found in Addendum BB to this final available via the Internet on the CMS also has a WAC price of $30.57 per 10 rule with comment period rule (which Web site). mg. The commenter believed that when is available via the Internet on the CMS We invited public comments on these the new HCPCS code was added with a Web site). Table 82 below lists Category proposed payment indicators and the description of 10 mg instead of the prior III CPT code 0474T, along with its final proposed payment rates for the new 1 mg, the payment rate was not payment indicator. The CY 2018 final Category III CPT code and Level II appropriately adjusted to reflect the payment rate for this new Category III HCPCS codes that were or are expected dosage change. CPT code can be found in Addendum to be newly recognized as ASC covered Response: We agree with the AA to the final rule with comment surgical procedures or covered ancillary commenter. The July 2017 and October period (which is available via the services in July 2017 through the 2017 OPPS and ASC addenda Internet on the CMS Web site).
TABLE 81—NEW LEVEL II HCPCS CODES FOR COVERED SURGICAL PROCEDURES AND ANCILLARY SERVICES EFFECTIVE ON JULY 1, 2017
CY 2018 CY 2017 CY 2018 CY 2018 Long Payment HCPCS Code CPCS Code descriptor indicator
C9489 ...... J2326 ...... Injection, nusinersen, 0.1 mg ...... K2 C9490 ...... J0565 ...... Injection, bezlotoxumab, 10 mg ...... K2 C9745 ...... C9745 ...... Nasal endoscopy, surgical; balloon dilation of eustachian tube ...... J8
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TABLE 81—NEW LEVEL II HCPCS CODES FOR COVERED SURGICAL PROCEDURES AND ANCILLARY SERVICES EFFECTIVE ON JULY 1, 2017—Continued
CY 2018 CY 2017 CY 2018 CY 2018 Long Payment HCPCS Code CPCS Code descriptor indicator
C9746 ...... C9746 ...... Transperineal implantation of permanent adjustable balloon continence device, with J8 cystourethroscopy, when performed and/or fluoroscopy, when performed. C9747 ...... C9747 ...... Ablation of prostate, transrectal, high intensity focused ultrasound (HIFU), including imaging guid- J8 ance. Q9986 ...... J1726 ...... Injection, hydroxyprogesterone caproate (Makena), 10 mg ...... K2 Q9989 * ...... J3358 ...... Ustekinumab, for intravenous injection, 1 mg ...... K2 * HCPCS code C9487, which was effective April 1, 2017, was replaced with HCPCS code Q9989 (Ustekinumab, for intravenous injection, 1 mg) effective July 1, 2017.
TABLE 82—NEW CATEGORY III CPT CODE FOR COVERED SURGICAL PROCEDURE EFFECTIVE ON JULY 1, 2017
CY 2018 CY 2017 CY 2018 CY 2018 Payment CPT Code CPT Code Long descriptor indicator
0474T ...... 0474T ...... Insertion of anterior segment aqueous drainage device, with creation of intraocular reservoir, in- J8 ternal approach, into the supraciliary space.
4. Process for New and Revised Level II 5. Process for Recognizing New and code with substantial revision to its HCPCS Codes That Are Effective Revised Category I and Category III CPT code descriptor in the next calendar October 1, 2017 and January 1, 2018 for Codes That Are Effective January 1, year, as compared to the current Which We Are Soliciting Public 2018 for Which We Are Soliciting calendar year, and that comments will Comments in This CY 2018 OPPS/ASC Public Comments in This CY 2018 be accepted on the proposed payment Final Rule With Comment Period OPPS/ASC Final Rule With Comment indicator. Further, in the proposed rule, Period we reminded readers that the CPT code As has been our practice in the past, descriptors that appear in Addendum we incorporate those new and revised For new and revised CPT codes AA and Addendum BB are short Level II HCPCS codes that are effective effective January 1, 2018, that were descriptors and do not fully describe the January 1 in the final rule with received in time to be included in the complete procedure, service, or item comment period, thereby updating the CY 2018 OPPS/ASC proposed rule, we described by the CPT code. Therefore, OPPS and the ASC payment system for proposed APC and status indicator we included the 5-digit placeholder the following calendar year. These assignments (82 FR 33657). We stated in codes and their long descriptors for the codes are released to the public via the the proposed rule that we would accept new and revised CY 2018 CPT codes in CMS HCPCS Web site, and also through comments and finalize the APC and Addendum O to the proposed rule the January OPPS quarterly update CRs. status indicator assignments in the CY (which is available via the Internet on In the past, we also released new and 2018 OPPS/ASC final rule with the CMS Web site) so that the public can revised Level II HCPCS codes that are comment period. For those new/revised have time to adequately comment on effective October 1 through the October CPT codes that were received too late our proposed payment indicator OPPS quarterly update CRs and for inclusion in the CY 2018 OPPS/ASC assignments. We stated in the proposed incorporated these new codes in the proposed rule, we stated that we may rule that the 5-digit placeholder codes final rule with comment period. either make interim final assignments in can be found in Addendum O, In the CY 2018 OPPS/ASC proposed the final rule with comment period or specifically under the column labeled rule (82 FR 33657), for CY 2018, possibly use HCPCS G-codes that mirror ‘‘CY 2018 OPPS/ASC Proposed Rule 5- consistent with our established policy, the predecessor CPT codes and retain Digit Placeholder Code,’’ to the we proposed that the Level II HCPCS the current APC and status indicator proposed rule. We stated that the final codes that will be effective October 1, assignments for a year until we can CPT code numbers would be included 2017, and January 1, 2018, would be propose APC and status indicator in the CY 2018 OPPS/ASC final rule flagged with comment indicator ‘‘NI’’ in assignments in the following year’s with comment period. We noted that Addendum B to the CY 2018 OPPS/ASC rulemaking cycle. not every code listed in Addendum O is final rule with comment period to We stated in the proposed rule that, subject to comment. For the new/ indicate that we have assigned the codes for the CY 2018 ASC update, the new revised Category I and III CPT codes, we an interim OPPS payment status for CY and revised CY 2018 Category I and III requested comments on only those 2018. We did not receive any public CPT codes will be effective on January codes that are assigned to comment comments on our proposal. As we stated 1, 2018, and were included in ASC indicator ‘‘NP’’. we would do in the proposed rule, we Addendum AA and Addendum BB to In summary, we solicited public are inviting public comments in this CY the proposed rule (which are available comments on the proposed CY 2018 2018 OPPS/ASC final rule with via the Internet on the CMS Web site). payment indicators for the new and comment period on the interim payment The new and revised CY 2018 Category revised Category I and III CPT codes that indicators and payment rates for these I and III CPT codes were assigned to will be effective January 1, 2018. The codes that will be finalized in the CY comment indicator ‘‘NP’’ to indicate CPT codes were listed in Addendum 2019 OPPS/ASC final rule with that the code is new for the next AA and Addendum BB to the proposed comment period. calendar year or the code is an existing rule with short descriptors only. We
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listed them again in Addendum O to the relative payment weight for the identified in Addendum AA to that rule proposed rule with long descriptors. We procedure by the ASC conversion factor by payment indicator ‘‘P2’’ (Office- also proposed to finalize the payment for that same year. We have no cost data based surgical procedure added to ASC indicator for these codes (with their or information to assess whether ASC list in CY 2008 or later with MPFS final CPT code numbers) in the CY 2018 payments rates calculated using the nonfacility PE RVUs; payment based on OPPS/ASC final rule with comment standard ratesetting methodology align OPPS relative payment weight); ‘‘P3’’ period. The proposed payment with ASC costs. Therefore, we are not (Office-based surgical procedures added indicators for these codes were included accepting the commenter’s to ASC list in CY 2008 or later with in Addendum AA and Addendum BB to recommendation and we are finalizing MPFS nonfacility PE RVUs; payment the proposed rule (which are available payment for proposed CPT codes based on MPFS nonfacility PE RVUs); or via the Internet on the CMS Web site). 31XX2, 31XX3, 31XX4, and 31XX5, as ‘‘R2’’ (Office-based surgical procedure Comment: Some commenters replaced by CPT codes 31253, 31257, added to ASC list in CY 2008 or later addressed the proposed establishment 31259, and 31298, respectively, without MPFS nonfacility PE RVUs; of HCPCS G-codes under the MPFS to according to our standard ASC payment based on OPPS relative report the insertion and removal of ratesetting methodology for CY 2018. payment weight), depending on whether buprenorphine hydrochloride, We note the OPPS cost data informs we estimated the procedure would be formulated as a 4-rod, 80 mg, long- ASC payment rates, and as data become paid according to the standard ASC acting subdermal drug implant for the available from hospitals paid under the payment methodology based on its treatment of opioid addiction (82 FR OPPS, we will reassess the APC OPPS relative payment weight or at the 34011 through 34012). Specifically, the assignments for these codes. MPFS nonfacility PE RVU-based commenters requested that the MPFS After consideration of the public amount. proposal also apply to the OPPS and comments we received, we are Consistent with our final policy to ASC payment systems. In addition, the finalizing, without modification, the annually review and update the list of commenters recommended that CMS proposed CY 2018 ASC payment covered surgical procedures eligible for assign the HCPCS G-codes to payment indicator assignments for new and payment in ASCs, each year we identify indicator ‘‘P3’’ (Office-based surgical revised CPT codes, effective January 1, covered surgical procedures as either procedure added to ASC list in CY 2008 2018. The final CY 2018 payment temporarily office-based (these are new or later with MPFS nonfacility Practice indicators for the new and revised procedure codes with little or no Expense Relative Value Units (PE Category I and III CPT codes (with their utilization data that we have determined RVUs); payment based on MPFS final CPT code numbers) that will be are clinically similar to other nonfacility PE RVUs). effective January 1, 2018 are listed in procedures that are permanently office- Response: As discussed in section Addendum AA and Addendum BB to based), permanently office-based, or III.D. (OPPS APC-Specific Policies) of this final rule with comment period nonoffice-based, after taking into this final rule with comment period, we with short descriptors only. We list account updated volume and utilization are establishing these HCPCS G-codes in them again in Addendum O to the final data. the OPPS, effective January 1, 2018, rule with comment period with long with status indicator ‘‘Q1’’ (Packaged (2) Changes for CY 2018 to Covered descriptors. APC payment if billed on the same Surgical Procedures Designated as Office-Based claim as a HCPCS code assigned status C. Update to the List of ASC Covered indicator ‘‘S’’, ‘‘T’’, or ‘‘V’’). However, Surgical Procedures and Covered In developing the CY 2018 OPPS/ASC because these services are conditionally Ancillary Services proposed rule and this final rule with packaged under the OPPS, they are comment period, we followed our unconditionally packaged under the 1. Covered Surgical Procedures policy to annually review and update ASC payment system (payment a. Covered Surgical Procedures the covered surgical procedures for indicator ‘‘N1’’). Therefore, we are not Designated as Office-Based which ASC payment is made and to identify new procedures that may be accepting the commenters’ request to (1) Background assign payment indicator ‘‘P3’’ to these appropriate for ASC payment, including HCPCS G-codes. In the August 2, 2007 ASC final rule, their potential designation as office- Comment: One commenter disagreed we finalized our policy to designate as based. We reviewed CY 2016 volume with the proposed payment rate for four ‘‘office-based’’ those procedures that are and utilization data and the clinical new CPT codes (31XX2, 31XX3, 31XX4, added to the ASC list of covered characteristics for all covered surgical and 31XX5) that describe endoscopic surgical procedures in CY 2008 or later procedures that are assigned payment sinus surgery services. The commenter years that we determine are performed indicator ‘‘G2’’ (Nonoffice-based noted that the multiple procedure predominantly (more than 50 percent of surgical procedure added in CY 2008 or reduction applies to these procedures the time) in physicians’ offices based on later; payment based on OPPS relative when performed in an ASC which consideration of the most recent payment weight) in CY 2016, as well as results in payment at 100 percent for the available volume and utilization data for for those procedures assigned one of the highest ranking procedure and 50 each individual procedure code and/or, temporary office-based payment percent for each subsequent procedure if appropriate, the clinical indicators, specifically ‘‘P2’’, ‘‘P3’’, or when performed in the same encounter. characteristics, utilization, and volume ‘‘R2’’ in the CY 2017 OPPS/ASC final Because the commenter believed that of related codes. In that rule, we also rule with comment period (81 FR 79736 these payment rates are inadequate, the finalized our policy to exempt all through 79738). commenter requested that CMS consider procedures on the CY 2007 ASC list As discussed in the CY 2018 OPPS/ an ASC payment rate that more closely from application of the office-based ASC proposed rule, our review of the aligns with ASCs’ costs. classification (72 FR 42512). The CY 2016 volume and utilization data Response: The national unadjusted procedures that were added to the ASC resulted in our identification of two ASC payment rates are calculated using list of covered surgical procedures covered surgical procedures, CPT code our standard ASC ratesetting beginning in CY 2008 that we 37241 (Vascular embolize/occlude methodology of multiplying the ASC determined were office-based were venous) and CPT code 67227
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(Destruction extensive retinopathy), that time in physicians’ offices, and we we proposed to permanently designate we believe meet the criteria for believe that the services are of a level of as office-based for CY 2018 were listed designation as office-based. The data complexity consistent with other in Table 34 of the proposed rule. indicate that these procedures are procedures performed routinely in performed more than 50 percent of the physicians’ offices. The CPT codes that
TABLE 83—ASC COVERED SURGICAL PROCEDURES NEWLY DESIGNATED AS PERMANENTLY OFFICE-BASED FOR CY 2018
CY 2017 CY 2018 CY 2018 ASC ASC CPT Code CY 2018 Long descriptor Payment Payment indicator indicator *
37241 ...... Vascular embolization or occlusion, inclusive of all radiological supervision and interpretation, G2 P3 intraprocedural roadmapping, and imaging guidance necessary to complete the intervention; venous, other than hemorrhage (eg, congenital or acquired venous malformations, venous and capillary hemangiomas, varices, varioceles). 67227 ...... Destruction of extensive or progressive retinopathy (eg, diabetic retinopathy), cryotherapy, dia- G2 P3 thermy. * Payment indicators are based on a comparison of the final rates according to the ASC standard ratesetting methodology and the MPFS final rates. Current law specifies a 0.5 percent update to the MPFS payment rates for CY 2018. For a discussion of the MPFS rates, we refer readers to the CY 2018 MPFS final rule with comment period.
We also reviewed CY 2016 volume catheter (includes imaging guidance, healing, high energy, including topical and utilization data and other when performed)); CPT code 65785 application and dressing care; initial information for 10 procedures (Implantation of intrastromal corneal wound) was finalized for temporary designated as temporary office-based in ring segments); and CPT code 67229 office-based status in the CY 2017 Tables 48 and 49 in the CY 2017 OPPS/ (Treatment of extensive or progressive OPPS/ASC final rule with comment ASC final rule with comment period (81 retinopathy, one or more sessions; period. However, this code will be FR 79736 through 79738). Of these 10 preterm infant (less than 37 weeks deleted by the AMA, effective December procedures, there were very few claims gestation at birth), performed from birth 31, 2017. in our data and no claims data for 8 up to 1 year of age (for example, We invited public comment on our procedures: CPT code 0402T (Collagen retinopathy of prematurity), proposals. cross-linking of cornea (including photocoagulation or cryotherapy). removal of the corneal epithelium and Consequently, we proposed to maintain Comment: One commenter objected to intraoperative pachymetry when the temporary office-based designations the proposal to designate CPT codes performed)); CPT code 10030 (Image- for these eight codes for CY 2018. We 10030, 36473, and 36901 as temporarily guided fluid collection drainage by listed all of these codes for which we office-based procedures for CY 2018. catheter (eg, abscess, hematoma, seroma, proposed to maintain the temporary The commenter did not provide a lymphocele, cyst), soft tissue (eg, office-based designations for CY 2018 in clinical rationale but stated that, in the extremity, abdominal wall, neck), Table 35 of the proposed rule. The absence of data to examine site of percutaneous); CPT code 36473 procedures for which the proposed service, it is premature to designate (Endovenous ablation therapy of office-based designations for CY 2018 these CPT codes as temporarily office- incompetent vein, extremity, inclusive are temporary also were indicated by based. of all imaging guidance and monitoring, asterisks in Addendum AA to the Response: In consultation with our percutaneous, mechanochemical; first proposed rule (which is available via medical advisors, we reviewed the vein treated); CPT code 36901 the Internet on the CMS Web site). clinical characteristics, utilization, and (Introduction of needle(s) and/or The volume and utilization data for volume of related codes and determined one procedure that has a temporary catheter(s), dialysis circuit, with that the procedures described by CPT office-based designation for CY 2017, diagnostic angiography of the dialysis codes 10030, 36473, and 36901 would circuit, including all direct puncture(s) HCPCS code G0429 (Dermal injection be predominantly performed in and catheter placement(s), injection(s) procedure(s) for facial lipodystrophy physicians’ offices. However, because of contrast, all necessary imaging from syndrome (LDS) and provision of we do not have utilization data for these the arterial anastomosis and adjacent Radiesse or Sculptra dermal filler, CPT codes, we made the office-based artery through entire venous outflow including all items and supplies), is designation temporary rather than including the inferior or superior vena sufficient to indicate that this procedure permanent for CY 2018. We will cava, fluoroscopic guidance, is performed predominantly in reevaluate office-based status for CPT radiological supervision and physicians’ offices and, therefore, codes 10030, 36473, and 36901 in the interpretation and image documentation should be assigned an office-based and report); CPT code 64461 payment indicator in CY 2018. CY 2019 rulemaking. (Paravertebral block (PVB) (paraspinous Consequently, we proposed to assign After consideration of the public block), thoracic; single injection site payment indicator ‘‘P2/P3’’ to this comment we received, for CY 2018 we (includes imaging guidance, when covered surgical procedure code in CY are finalizing our proposal, without performed); CPT code 64463 2018. modification, to designate the (Paravertebral block (PVB) (paraspinous HCPCS code 0299T (Extracorporeal procedures listed in Table 84 below as block), thoracic; continuous infusion by shock wave for integumentary wound temporary office-based.
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TABLE 84—CY 2018 PAYMENT INDICATORS FOR ASC COVERED SURGICAL PROCEDURES DESIGNATED AS TEMPORARY OFFICE-BASED IN THE CY 2018 OPPS/ASC FINAL RULE WITH COMMENT PERIOD
CY 2017 CY 2018 CY 2018 ASC ASC CPT code CY 2018 long descriptor payment payment indicator * indicator **
0299T ...... Extracorporeal shock wave for integumentary wound healing, high energy, including topical R2 * NA application and dressing care; initial wound. 0402T ...... Collagen cross-linking of cornea (including removal of the corneal epithelium and R2 * R2 ** intraoperative pachymetry when performed). 10030 ...... Image-guided fluid collection drainage by catheter (e.g., abscess, hematoma, seroma, P2 * P2 ** lymphocele, cyst), soft tissue (e.g., extremity abdominal wall, neck), percutaneous. 36473 ...... Endovenous ablation therapy of incompetent vein, extremity, inclusive of all imaging guid- P2 * P2 ** ance and monitoring, percutaneous, mechanochemical; first vein treated. 36901 ...... Introduction of needle(s) and/or catheter(s), dialysis circuit, with diagnostic angiography of P2 * P2 ** the dialysis circuit, including all direct puncture(s) and catheter placement(s), injection(s) of contrast, all necessary imaging from the arterial anastomosis and adjacent artery through entire venous outflow, including the inferior or superior vena cava, fluoroscopic guidance, radiological supervision and interpretation and image documentation and report. 64461 ...... Paravertebral block (PVB) (paraspinous block), thoracic; single injection site (includes imag- P3 * P3 ** ing guidance, when performed). 64463 ...... Continuous infusion by catheter (includes imaging guidance, when performed) ...... P3 * P3 ** 65785 ...... Implantation of intrastromal corneal ring segments ...... R2 * P2 ** 67229 ...... Treatment of extensive or progressive retinopathy, one or more sessions; preterm infant R2 * R2 ** (less than 37 weeks gestation at birth), performed from birth up to 1 year of age (e.g., ret- inopathy of prematurity), photocoagulation or cryotherapy. G0429 ...... Dermal injection procedure(s) for facial lipodystrophy syndrome (LDS) and provision of P3 * P3 ** Radiesse or Sculptra dermal filler, including all items and supplies. * If designation is temporary. ** Payment indicators are based on a comparison of the final rates according to the ASC standard ratesetting methodology and the MPFS final rates. Current law specifies a 0.5 percent update to the MPFS payment rates for CY 2018. For a discussion of the MPFS rates, we refer readers to the CY 2018 MPFS final rule with comment period.
In the CY 2018 OPPS/ASC proposed we had no utilization data for the We did not receive any public rule (82 FR 33660), for CY 2018, we procedure specifically described by this comments on our proposal. Therefore, proposed to designate one new CY 2018 new CPT code, we proposed to make the for CY 2018, we are finalizing our CPT code for ASC covered surgical office-based designation temporary proposal, without modification, to procedures as temporary office-based, as rather than permanent, and we stated designate CPT code 38222 as temporary displayed in Table 36 of the proposed that we will reevaluate the procedure office-based for CY 2018 as displayed in rule. After reviewing the clinical when data become available. The Table 85 of this final rule with comment characteristics, utilization, and volume procedure for which the proposed period. The procedure for which the of related procedure codes, we office-based designation for CY 2018 is office-based designation for CY 2018 is determined that the procedure temporary was indicated by asterisks in temporary is indicated by asterisks in described by this new CPT code would Addendum AA to the proposed rule Addendum AA to this final rule with be predominantly performed in (which is available via the Internet on comment period (which is available via physicians’ offices. However, because the CMS Web site). the Internet on the CMS Web site).
TABLE 85—CY 2018 PAYMENT INDICATORS FOR NEW CY 2018 CPT CODES FOR ASC COVERED SURGICAL PROCEDURES DESIGNATED AS TEMPORARY OFFICE-BASED
CY 2017 OPPS/ASC proposed CY 2018 rule 5-digit CY 2018 CY 2018 long descriptor ASC CMS CPT code payment placeholder indicator ** code
382X3 ...... 38222 ...... Diagnostic bone marrow; biopsy(ies) and aspiration(s) ...... P3 * * If designation is temporary. ** Payment indicators are based on a comparison of the final rates according to the ASC standard ratesetting methodology and the MPFS final rates. Current law specifies a 0.5 percent update to the MPFS payment rates for CY 2018. For a discussion of the MPFS rates, we refer readers to the CY 2018 MPFS final rule with comment period.
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b. ASC Covered Surgical Procedures To describe procedures that involve the in this final rule with comment period Be Designated as Device-Intensive implantation of medical devices would and effective January 1, 2018) as a (1) Background be to ensure ASC access for new device-intensive procedure in the ASC. procedures until claims data become The commenter stated that the As discussed in the CY 2017 OPPS/ available. However, in certain rare procedure described by CPT code 55874 ASC final rule with comment period (81 instances, for example, in the case of a requires the implantation of an FR 79739 through 79740), we very expensive implantable device, we expensive device which represents an implemented a payment methodology may temporarily assign a higher offset approximate range of 80 to 87 percent for calculating the ASC payment rates percentage if warranted by additional of the procedure cost. for covered surgical procedures that are information, such as pricing data from Response: When claims data are designated as device-intensive. Under a device manufacturer. Once claims data available for a new procedure requiring § 416.171(b)(2) of the regulations, we are available for a new procedure the implantation of a medical device, define an ASC device-intensive involving the implantation of a medical device-intensive status will be applied procedure as a procedure with a HCPCS device, the device-intensive designation to the code if the HCPCS code level code-level device offset of greater than will be applied to the code if the HCPCS device offset is greater than 40 percent, 40 percent when calculated according to code device offset is greater than 40 according to our finalized policy of the standard OPPS APC ratesetting percent, according to our policy of determining device-intensive status by methodology. determining device-intensive status, by calculating the HCPCS code-level device According to this ASC payment calculating the HCPCS code-level device offset (81 FR 79658). With respect to methodology, we apply the device offset offset. CPT code 55874, although the CPT code percentage based on the standard OPPS is new, the procedure itself was APC ratesetting methodology to the (2) Changes to List of ASC Covered previously described by two OPPS national unadjusted payment to Surgical Procedures Designated as predecessor codes, HCPCS code C9743 determine the device cost included in Device-Intensive for CY 2018 and CPT code 0438T, for which we have the OPPS payment rate for a device- In the CY 2018 OPPS/ASC proposed claims data. Therefore, based on our intensive ASC covered surgical rule, for CY 2018, we proposed to analysis of the OPPS claims data used procedure, which we then set as equal update the ASC list of covered surgical to determine the packaged device costs to the device portion of the national procedures that are eligible for payment attributed to the predecessor HCPCS unadjusted ASC payment rate for the according to our device-intensive codes, CPT code 55874 is not eligible for procedure. We calculate the service procedure payment methodology, device-intensive status because the portion of the ASC payment for device- reflecting the proposed individual device offset for its predecessor codes intensive procedures by applying the HCPCS code device-offset percentages are below the 40 percent threshold. For uniform ASC conversion factor to the based on CY 2016 OPPS claims and cost more information on how codes are service (non-device) portion of the report data available for the proposed designated as device-intensive status, OPPS relative payment weight for the rule (82 FR 33660). we refer readers to section IV.B. (Device- device-intensive procedure. Finally, we The ASC covered surgical procedures Intensive Procedures) of this final rule sum the ASC device portion and ASC that we proposed to designate as device- with comment period. service portion to establish the full intensive, and therefore subject to the Comment: Commenters requested that payment for the device-intensive device-intensive procedure payment CMS designate CPT code 0275T, a procedure under the revised ASC methodology for CY 2018, are assigned procedure described as percutaneous payment system. payment indicator ‘‘J8’’ and were image guided lumbar decompression We also finalized that device- included in Addendum AA to the (PILD) for lumbar spinal stenosis, as a intensive procedures will be subject to proposed rule (which is available on the device-intensive procedure until claims all of the payment policies applicable to CMS Web site). The CPT code, the CPT data become available. Commenters procedures designated as an ASC code short descriptor, the proposed CY stated that, beginning in CY 2017, PILD device-intensive procedure under our 2018 ASC payment indicator, and an is the only procedure reported with CPT established methodology, including our indication of whether the full credit/ code 0275T. In addition, to ensure CMS policies on device credits and partial credit (FB/FC) device adjustment collects robust data on the cost of the discontinued procedures. policy would apply also were included device, one commenter requested that In addition, in the CY 2017 OPPS/ in Addendum AA to the proposed rule. CMS establish a specific device code. ASC final rule with comment period, we We invited public comments on the Response: As discussed in section adopted a policy for new HCPCS codes proposed list of ASC device-intensive IV.B.2 of this final rule with comment describing procedures involving the procedures. period, claims data for CPT code 0275T implantation of medical devices that do Comment: A few commenters shows that the percentage of packaged not yet have associated claims data, to requested that CMS lower the ASC device cost is below the 40 percent designate these procedures as device- device offset threshold to 30 percent to threshold; therefore, it is not eligible for intensive with a default device offset set qualify a larger number of ASC designation as a device-intensive at 41 percent until claims data are procedures as device-intensive. procedure. CPT code 0275T was available to establish the HCPCS code- Response: We did not propose to implemented as a payable code in the level device offset for the procedures (81 change to lower the ASC device offset OPPS and ASC settings on July 1, 2011 FR 79739 through 79740). This default threshold and, therefore, are not (July 2011 OPPS Update, Transmittal device offset amount of 41 percent accepting this request. We note that we 2234, Change Request 7443). We are would not be calculated from claims addressed a similar comment in the CY unclear why a separate device code is data; instead, it would be applied as a 2017 OPPS/ASC final rule with needed if PILD is the only procedure default until claims data are available comment period, and we refer readers to reported with CPT code 0275T. upon which to calculate an actual our response (81 FR 79739). Comment: One commenter requested device offset for the new code. The Comment: One commenter requested that CMS designate CPT code 67027 purpose of applying the 41-percent that CMS designate CPT code 55X87 (Implant eye drug system) as a device- default device offset to new codes that (which is replaced by CPT code 55874 intensive procedure in the ASC.
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Response: CPT code 67027 does not policy was to reduce OPPS payment by procedures that are subject to the no have a device offset that is greater than 100 percent of the device offset amount cost/full credit or partial credit device 40 percent. Accordingly, it is not when a hospital furnished a specified adjustment policy by one-half of the device-intensive under current policy. device without cost or with a full credit device offset amount that would be After consideration of the public and by 50 percent of the device offset applied if a device was provided at no comments we received, we are amount when the hospital received cost or with full credit, if the credit to designating the ASC covered surgical partial credit in the amount of 50 the ASC is 50 percent or more (but less procedures displayed in Addendum AA percent or more (but less than 100 than 100 percent) of the cost of the new as device-intensive and subject to the percent) of the cost for the specified device. The ASC would append the device-intensive procedure payment device. For CY 2014, we finalized our HCPCS ‘‘FC’’ modifier to the HCPCS methodology for CY 2018. The CPT proposal to reduce OPPS payment for code for a device-intensive surgical code, the CPT code short descriptor, the applicable APCs by the full or partial procedure that is subject to the no cost/ final CY 2018 ASC payment indicator, credit a provider receives for a replaced full credit or partial credit device and an indication of whether the full device, capped at the device offset adjustment policy, when the facility credit/partial credit (FB/FC) device amount. receives a partial credit of 50 percent or adjustment policy will apply are Although we finalized our proposal to more (but less than 100 percent) of the included in the ASC policy file labeled modify the policy of reducing payments cost of a device. To report that the ASC ‘‘CY 2018 ASC Procedures to which the when a hospital furnishes a specified received a partial credit of 50 percent or No Cost/Full Credit and Partial Credit device without cost or with full or more (but less than 100 percent) of the Device Adjustment Policy Applies,’’’ partial credit under the OPPS, in that cost of a new device, ASCs would have which is available via the Internet on final rule with comment period (78 FR the option of either: (1) Submitting the the CMS Web site at: https:// 75076 through 75080), we finalized our claim for the device replacement www.cms.gov/Medicare/Medicare-Fee- proposal to maintain our ASC policy for procedure to their Medicare contractor for-Service-Payment/ASCPayment/ASC- reducing payments to ASCs for after the procedure’s performance, but Policy-Files.html. specified device-intensive procedures prior to manufacturer acknowledgment when the ASC furnishes a device c. Adjustment to ASC Payments for No of credit for the device, and without cost or with full or partial Cost/Full Credit and Partial Credit subsequently contacting the contractor credit. Unlike the OPPS, there is Devices regarding a claim adjustment, once the currently no mechanism within the ASC credit determination is made; or (2) Our ASC payment policy for costly claims processing system for ASCs to holding the claim for the device devices implanted in ASCs at no cost/ submit to CMS the actual amount implantation procedure until a full credit or partial credit, as set forth received when furnishing a specified determination is made by the in § 416.179 of our regulations, is device at full or partial credit. manufacturer on the partial credit and consistent with the OPPS policy that Therefore, under the ASC payment submitting the claim with the ‘‘FC’’ was in effect until CY 2014. system, we finalized our proposal for modifier appended to the implantation Specifically, the OPPS policy that was CY 2014 to continue to reduce ASC procedure HCPCS code if the partial in effect through CY 2013 provided a payments by 100 percent or 50 percent credit is 50 percent or more (but less reduction in OPPS payment by 100 of the device offset amount when an than 100 percent) of the cost of the percent of the device offset amount ASC furnishes a device without cost or replacement device. Beneficiary when a hospital furnishes a specified with full or partial credit, respectively. coinsurance would be based on the device without cost or with a full credit In the CY 2018 OPPS/ASC proposed reduced payment amount. As finalized and by 50 percent of the device offset rule (82 FR 33661), we proposed to in the CY 2015 OPPS/ASC final rule amount when the hospital receives update the list of ASC covered device- with comment period (79 FR 66926), to partial credit in the amount of 50 intensive procedures that would be ensure our policy covers any situation percent or more of the cost for the subject to the no cost/full credit and involving a device-intensive procedure specified device (77 FR 68356 through partial credit device adjustment policy where an ASC may receive a device at 68358). The established ASC policy for CY 2018. Specifically, when a no cost/full credit or partial credit, we reduces payment to ASCs when a device-intensive procedure is subject to apply our FB/FC policy to all device- specified device is furnished without the no cost/full credit or partial credit intensive procedures. cost or with full credit or partial credit device adjustment policy and is We invited public comments on our for the cost of the device for those ASC performed to implant a device that is proposals to adjust ASC payments for covered surgical procedures that are furnished at no cost or with full credit no cost/full credit and partial credit assigned to APCs under the OPPS to from the manufacturer, the ASC would devices. which this policy applies. We refer append the HCPCS ‘‘FB’’ modifier on We did not receive any public readers to the CY 2009 OPPS/ASC final the line in the claim with the procedure comment on these proposals. Therefore, rule with comment period for a full to implant the device. The contractor we are finalizing these proposals discussion of the ASC payment would reduce payment to the ASC by without modification. Specifically, we adjustment policy for no cost/full credit the device offset amount that we will apply the HCPCS ‘‘FB’’/‘‘FC’’ and partial credit devices (73 FR 68742 estimate represents the cost of the modifier policy to all device-intensive through 68744). device when the necessary device is procedures in CY 2018. For CY 2018, we As discussed in section IV.B. of the furnished without cost or with full will reduce the payment for the CY 2014 OPPS/ASC final rule with credit to the ASC. We continue to procedures listed in the ASC device comment period (78 FR 75005 through believe that the reduction of ASC adjustment file by the full device offset 75006), we finalized our proposal to payment in these circumstances is amount if a device is furnished without modify our former policy of reducing necessary to pay appropriately for the cost or with full credit. ASCs must OPPS payment for specified APCs when covered surgical procedure furnished by append the HCPCS modifier ‘‘FB’’ to the a hospital furnishes a specified device the ASC. HCPCS code for a surgical procedure without cost or with a full or partial For partial credit, we proposed to listed in the ASC device adjustment file credit. Formerly, under the OPPS, our reduce the payment for implantation previously mentioned when the device
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is furnished without cost or with full list of ASC covered surgical procedures appropriate care setting for a given credit. In addition, for CY 2018, we will for CY 2018. surgical procedure is made by the reduce the payment for the procedures The procedures that we proposed to physician based on the beneficiary’s listed in the ASC device adjustment file add to the ASC list of covered surgical individual clinical needs and by one-half of the device offset amount procedures, including the HCPCS code preferences. In addition, as discussed in if a device is provided with partial long descriptors and the proposed CY the CY 2012 OPPS/ASC final rule with credit, if the credit to the ASC is 50 2018 payment indicators, were comment period (76 FR 74377 and percent or more (but less than 100 displayed in Table 37 of the proposed 74378), section 1832(a)(2)(F)(i) of the percent) of the device cost. The ASC rule. We invited public comments on Act provides that benefits under must append the HCPCS ‘‘FC’’ modifier our proposals. Medicare Part B include payment for to the HCPCS code for a surgical Comment: Some commenters facility services furnished in connection procedure listed in the ASC device supported adding the three procedures with surgical procedures specified by adjustment file when the facility described by CPT codes 22856, 22858, the Secretary that are performed in an receives a partial credit of 50 percent or and 58572 to the ASC list of covered ASC. Under 42 CFR 416.2 and 416.166 more (but less than 100 percent) of the surgical procedures. These commenters of the Medicare regulations, subject to cost of a device. believed that all three procedures met certain exclusions, we define covered the criteria to be added to the ASC list surgical procedures as those procedures d. Additions to the List of ASC Covered of covered surgical procedures. which are separately paid under the Surgical Procedures Response: We appreciate the OPPS, would not be expected to pose a As discussed in the CY 2018 OPPS/ commenters’ support. As indicated later significant risk to beneficiary safety ASC proposed rule (82 FR 33661), we in this section, we are finalizing our when performed in an ASC, and for conducted a review of HCPCS codes proposal to add these procedures to the which standard medical practice that currently are paid under the OPPS, ASC list of covered surgical procedures. dictates that the beneficiary would not but not included on the ASC list of Comment: One commenter suggested typically be expected to require active covered surgical procedures, to that including the procedures described medical monitoring and care at determine if changes in technology and/ by CPT codes 22856, 22858, and 58572 midnight following the procedure. We or medical practice affected the clinical on the ASC list of covered surgical believe it is appropriate and necessary appropriateness of these procedures for procedures would allow physicians to to include procedures that meet these the ASC setting. Based on this review, inappropriately direct patients to criteria on the list of ASC covered we proposed to update the list of ASC receive these procedures in an ASC surgical procedures for Medicare covered surgical procedures by adding setting with which they have a financial patients who may be suitable candidates three procedures to the list for CY 2018. relationship rather than an inpatient to undergo these procedures in an ASC These procedures included procedures hospital setting, and thereby jeopardize setting. described by CPT codes 22856, 22858, patient access to these procedures in an After consideration of the public and 58572. We determined that these inpatient setting. comments we received, we are three procedures are separately paid Response: We do not believe that finalizing our proposal to add the three under the OPPS, would not be expected including the procedures described by procedures described by CPT codes to pose a significant risk to beneficiary CPT codes 22856, 22858, and 58572 on 22856, 22858, and 58572 to the ASC list safety when performed in an ASC, and the ASC list of covered surgical of covered surgical procedures. The would not be expected to require active procedures would lead to inappropriate procedures that we are adding to the medical monitoring and care of the shifting of patients to the ASC setting or ASC list of covered surgical procedures, beneficiary at midnight following the jeopardize access to these procedures in including the code long descriptors and procedure. Therefore, we proposed to an inpatient hospital setting. We believe the final CY 2018 payment indicators, include these three procedures on the the decision regarding the most are displayed in Table 86 below.
TABLE 86—ADDITIONS TO THE LIST OF ASC COVERED SURGICAL PROCEDURES FOR CY 2018
CY 2018 CY 2018 ASC CPT code CY 2018 long descriptor payment indicator
22856 ...... Total disc arthroplasty (artificial disc), anterior approach, including discectomy with end plate preparation (in- J8 cludes osteophytectomy for nerve root or spinal cord decompression and microdissection); single inter- space, cervical. 22858 ...... Total disc arthroplasty (artificial disc), anterior approach, including discectomy with end plate preparation (in- N1 cludes osteophytectomy for nerve root or spinal cord decompression and microdissection); second level, cervical (list separately in addition to code for primary procedure). 58572 ...... Laparoscopy, surgical, with total hysterectomy, for uterus greater than 250g ...... G2
e. Discussion of Comment Solicitation surgical procedures, a review of the the TKA procedure described by CPT on Adding Additional Procedures to the procedures that are being proposed for code 27447 should be removed from the ASC Covered Procedures List removal from the OPPS IPO list for OPPS IPO list. During the comment possible inclusion on the ASC list of period, some stakeholders requested As we discussed in the CY 2009 covered surgical procedures. that CMS also add the TKA procedure OPPS/ASC final rule with comment to the list of surgical procedures covered period (73 FR 68724), we adopted a In the CY 2017 OPPS/ASC proposed policy to include, in our annual rule (81 FR 45679 through 45681), we in an ASC setting. In the CY 2017 OPPS/ evaluation of the ASC list of covered solicited comments regarding whether ASC proposed rule, we solicited public
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comments on removing the TKA comments on whether CPT codes 27125 Medicare patients are not suitable procedure from the OPPS IPO list for CY (Hemiarthroplasty, hip, partial (eg, candidates to receive ‘‘overnight’’ joint 2017. However, in the CY 2018 OPPS/ femoral stem prosthesis, bipolar arthroplasty procedures in an ASC ASC proposed rule (82 FR 33643 arthroplasty)) and 27130 (Arthroplasty, setting. through 33644), we proposed to remove acetabular and proximal femoral Response: We appreciate the feedback the TKA procedure from the OPPS IPO prosthetic replacement (total hip we received as to whether TKA, partial list for CY 2018, as discussed in section arthroplasty), with or without autograft and total hip replacement procedures IX. of both the proposed rule and this or allograft) meet the criteria to be meet the criteria to be added to the ASC final rule with comment period. In light removed from the OPPS IPO list, as covered surgical procedures list. For CY of the public comments we received on discussed in section IX. of the proposed 2018, we are not removing CPT codes the CY 2017 OPPS/ASC proposed rule rule. As noted in that section, we also 27125 and 27130 from the OPPS IPO (81 FR 79697 through 79699) and our solicited comments on whether these list. While we are finalizing our proposal to remove the TKA procedure two procedures meet the criteria to be proposal to remove CPT codes 27447 from the OPPS IPO list for CY 2018, in added to the ASC covered surgical and 55866 from the OPPS IPO list for the CY 2018 OPPS/ASC proposed rule, procedures list. CY 2018, we are not adding these we solicited public comments on Comment: In addition to the procedures to the ASC covered surgical whether the TKA procedure should also comments CMS received as to whether procedures list for CY 2018. We be added to the ASC list of covered CPT codes 27447, 27125, 27130, and solicited comments on whether to add surgical procedures. We also invited 55866 should be removed from the these procedures to the ASC list of public comments on our proposed OPPS IPO list, several commenters covered surgical procedures, and we continued exclusion of CPT code 55866 suggested that these procedures should will take the suggestions and (Laparoscopy, surgical prostatectomy, be added to the ASC covered surgical recommendations into consideration for retropubic radical, including nerve procedures list. The commenters argued future rulemaking. sparing, includes robotic assistance, that many ASCs are equipped to Comment: Many commenters when performed) from the list of ASC perform these procedures and requested that CMS add certain CPT covered surgical procedures. orthopedic surgeons in ASCs are codes that are outside of the 10000– In considering whether or not the increasingly performing these 69999 CPT code surgical range. These TKA procedure should be added to the procedures safely and effectively on codes are shown in Table 87 below and ASC list of covered surgical procedures, non-Medicare patients and appropriate included gastrointestinal diagnostic we requested that commenters take into Medicare patients. They also noted that procedures, chemotherapy, cardiac consideration the regulations at 42 CFR CPT code 27446 (Arthroplasty, knee, catheterization procedures, and cardiac 416.2 and 416.166. We indicated that condyle and plateau; medial or lateral diagnostic procedures, as well as other commenters should assess, for example, compartment) is a similar procedure cardiology procedures. whether this procedure would be that is currently included on the list of expected to pose a significant risk to ASC covered surgical procedures. In TABLE 87—PROCEDURES REQUESTED beneficiary safety when performed in an addition, the commenters also stated BY COMMENTERS FOR ADDITION TO ASC, whether standard medical practice that adding TKA and partial and total THE CY 2018 LIST OF ASDC COV- dictates that the beneficiary would hip arthroplasty procedures to the ASC typically be expected to require active covered surgical procedures list allows ERED SURGICAL PROCEDURES for greater choices in care settings for medical monitoring and care at CY 2018 midnight following the procedure Medicare patients and would provide a CPT/ (‘‘overnight stay’’), and whether this more patient-centered approach to joint HCPCS CY 2018 short descriptor procedure would fall under our general arthroplasty procedures. Further, code exclusions for covered surgical commenters stated that, in some cases, procedures at 42 CFR 416.166(c) (for it may be safer to have joint arthroplasty 23470 ..... Reconstruct shoulder joint. 23472 ..... Reconstruct shoulder joint. example, would it generally result in procedures performed in an outpatient 27702 ..... Reconstruct ankle joint. extensive blood loss, require major or setting to prevent certain hospital- 27703 ..... Reconstruction ankle joint. prolonged invasion of body cavities, acquired infections. 91010 ..... Esophagus motility study. directly involve major blood vessels, Some commenters suggested a 91013 ..... Esophgl motil w/stim/perfus. among others). stepwise approach to transitioning TKA 91020 ..... Gastric motility studies. As discussed in the CY 2018 OPPS/ to the ASC setting and recommended 91022 ..... Duodenal motility study. ASC proposed rule, we evaluated each allowing performance of 1 to 2 years in 91030 ..... Acid perfusion of esophagus. of the procedures described by CPT the hospital outpatient department 91034 ..... Gastroesophageal reflux test. codes 27447 and 55866 that we setting before adding TKA to the ASC 91035 ..... G-esoph reflx tst w/electrod. proposed to remove from the OPPS IPO covered surgical procedures list. Other 91037 ..... Esoph imped function test. 91038 ..... Esoph imped funct test > 1hr. list for CY 2018 according to the criteria commenters recommended that ASCs 91040 ..... Esoph balloon distension tst. for inclusion on the list of ASC covered obtain enhanced certification from a 91110 ..... Gi tract capsule endoscopy. surgical procedures, and considered national accrediting organization that 91111 ..... Esophageal capsule endoscopy. whether they should be added to the list certifies an ASC meets higher quality 91112 ..... Gi wireless capsule measure. of ASC covered surgical procedures for standards to safely perform joint 91117 ..... Colon motility 6 hr study. CY 2018. We stated that, because our arthroplasty procedures. 91120 ..... Rectal sensation test. understanding is that these procedures Some commenters opposed adding 91122 ..... Anal pressure record. typically require more than 24 hours of procedures described by CPT codes 92920 ..... Prq cardiac angioplast 1 art. 27447, 27125, 27130, and 55866 to the 92921 ..... Prq cardiac angio addl art. active medical care following the 92924 ..... Prq card angio/athrect 1 art. procedure, we believed they should ASC covered surgical procedures list. 92925 ..... Prq card angio/athrect addl. continue to be excluded from the list of These commenters believed that the vast 92928 ..... Prq card stent w/angio 1 vsl. ASC covered surgical procedures. majority of ASCs are not equipped to 92929 ..... Prq card stent w/angio addl. In addition, in the CY 2018 OPPS/ safely perform these procedures on 92937 ..... Prq revasc byp graft 1 vsl. ASC proposed rule, we solicited patients and that the vast majority of 92938 ..... Prq revasc byp graft addl.
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TABLE 87—PROCEDURES REQUESTED we did not consider procedures that are calculate the national unadjusted BY COMMENTERS FOR ADDITION TO reported by CPT codes that are on the payment rates for procedures with THE CY 2018 LIST OF ASDC COV- OPPS IPO list. Codes that are on the payment indicators ‘‘G2’’ and ‘‘A2’’. ERED SURGICAL PROCEDURES— OPPS IPO list for CY 2018 are not Payment indicator ‘‘A2’’ was developed Continued eligible for addition to the ASC list of to identify procedures that were covered surgical procedures. included on the list of ASC covered As we discussed in section XII.A.3. of CY 2018 surgical procedures in CY 2007 and, CPT/ this final rule with comment period, we therefore, were subject to transitional HCPCS CY 2018 short descriptor solicited public comments regarding our payment prior to CY 2011. Although the code definition of a surgical procedures and 4-year transitional period has ended and whether services described by Category payment indicator ‘‘A2’’ is no longer 92960 ..... Cardioversion electric ext. I CPT codes outside of the surgical range required to identify surgical procedures 92973 ..... Prq coronary mech thrombect. (10000–69999), or Level II HCPCS codes 92978 ..... Endoluminl ivus oct c 1st. subject to transitional payment, we 92979 ..... Endoluminl ivus oct c ea. or Category III CPT codes that do not retained payment indicator ‘‘A2’’ 93312 ..... Echo transesophageal. directly crosswalk and are not clinically because it is used to identify procedures 93313 ..... Echo transesophageal. similar to procedures in the CPT that are exempted from the application 93315 ..... Echo transesophageal. surgical range, may nonetheless be of the office-based designation. 93316 ..... Echo transesophageal. appropriate to include as covered The rate calculation established for 93451 ..... Right heart cath. surgical procedures that are payable device-intensive procedures (payment 93452 ..... Left hrt cath w/ventrclgrphy. when furnished in the ASC setting. We indicator ‘‘J8’’) is structured so that the 93453 ..... R&l hrt cath w/ventriclgrphy. did not propose any revisions to our packaged device payment amount is the 93454 ..... Coronary artery angio s&i. definition of covered surgical same as under the OPPS, and only the 93455 ..... Coronary art/grft angio s&i. 93456 ..... R hrt coronary artery angio. procedures, and, for CY 2018, we service portion of the rate is subject to 93457 ..... R hrt art/grft angio. continue to use the current definition of the ASC standard ratesetting 93458 ..... L hrt artery/ventricle angio. surgical procedure. methodology. In the CY 2017 OPPS/ 93459 ..... L hrt art/grft angio. We appreciate the commenters’ ASC final rule with comment period (81 93460 ..... R&l hrt art/ventricle angio. recommendations for procedures that FR 79732 through 79753), we updated 93461 ..... R&l hrt art/ventricle angio. may be suitable candidates to include the CY 2016 ASC payment rates for ASC 93462 ..... L hrt cath trnsptl puncture. on the list of ASC covered surgical covered surgical procedures with 93463 ..... Drug admin & hemodynmic meas. procedures. We acknowledge that some payment indicators of ‘‘A2’’, ‘‘G2’’, and 93505 ..... Biopsy of heart lining. of the procedures may be ‘‘surgery-like.’’ ‘‘J8’’ using CY 2015 data, consistent 93530 ..... Rt heart cath congenital. 93531 ..... R & l heart cath congenital. However, we remain concerned that with the CY 2017 OPPS update. We also 93532 ..... R & l heart cath congenital. these procedures may impose a updated payment rates for device- 93533 ..... R & l heart cath congenital. significant safety risk to the Medicare intensive procedures to incorporate the 93563 ..... Inject congenital card cath. population in an ASC setting. For CY CY 2017 OPPS device offset percentages 93564 ..... Inject hrt congntl art/grft. 2018, we continue to rely on defining calculated under the standard APC 93565 ..... Inject l ventr/atrial angio. surgical procedures as those that are ratesetting methodology, as discussed 93566 ..... Inject r ventr/atrial angio. described by Category I CPT codes earlier in this section. 93567 ..... Inject suprvlv aortography. within the surgical range, or Level II Payment rates for office-based 93568 ..... Inject pulm art hrt cath. procedures (payment indicators ‘‘P2’’, 93600 ..... Bundle of his recording. HCPCS codes or Category III CPT codes 93602 ..... Intra-atrial recording. that directly crosswalk or are clinically ‘‘P3’’, and ‘‘R2’’) are the lower of the 93603 ..... Right ventricular recording. similar to procedures in the CPT MPFS nonfacility PE RVU-based 93612 ..... Intraventricular pacing. surgical range. Therefore, we do not amount (we refer readers to the CY 2018 93613 ..... Electrophys map 3d add-on. believe that the remaining codes should MPFS proposed and final rules) or the 93620 ..... Electrophysiology evaluation. be added to the list of ASC covered amount calculated using the ASC 93621 ..... Electrophysiology evaluation. surgical procedures for CY 2018 because standard rate setting methodology for 93622 ..... Electrophysiology evaluation. they do not meet our criteria for the procedure. In the CY 2017 OPPS/ 93623 ..... Stimulation pacing heart. inclusion on the list. However, we will ASC final rule with comment period, we 93624 ..... Electrophysiologic study. updated the payment amounts for 93650 ..... Ablate heart dysrhythm focus. take these comments into consideration 93653 ..... Ep & ablate supravent arrhyt. in future rulemakings. office-based procedures (payment indicators ‘‘P2’’, ‘‘P3’’, and ‘‘R2’’) using 93654 ..... Ep & ablate ventric tachy. D. ASC Payment for Covered Surgical 93655 ..... Ablate arrhythmia add on. the most recent available MPFS and 93656 ..... Tx atrial fib pulm vein isol. Procedures and Covered Ancillary OPPS data. We compared the estimated 93657 ..... Tx l/r atrial fib addl. Services CY 2017 rate for each of the office-based 96413 ..... Chemo iv infusion 1 hr. 1. ASC Payment for Covered Surgical procedures, calculated according to the 96415 ..... Chemo iv infusion addl hr. Procedures ASC standard rate setting methodology, 0237T ..... Trluml perip athrc brchiocph. to the MPFS nonfacility PE RVU-based 0398T ..... Mrgfus strtctc les abltj. a. Background amount to determine which was lower C9600 .... Perc drug-el cor stent sing. Our ASC payment policies for C9601 .... Perc drug-el cor stent bran. and, therefore, would be the CY 2017 C9602 .... Perc d-e cor stent ather s. covered surgical procedures under the payment rate for the procedure under C9603 .... Perc d-e cor stent ather br. revised ASC payment system are fully our final policy for the revised ASC C9604 .... Perc d-e cor revasc t cabg s. described in the CY 2008 OPPS/ASC payment system (§ 416.171(d)). C9605 .... Perc d-e cor revasc t cabg b. final rule with comment period (72 FR In the CY 2014 OPPS/ASC final rule 66828 through 66831). Under our with comment period (78 FR 75081), we Response: We reviewed all of the established policy, we use the ASC finalized our proposal to calculate the codes that commenters requested for standard ratesetting methodology of CY 2014 payment rates for ASC covered addition to the ASC list of covered multiplying the ASC relative payment surgical procedures according to our surgical procedures. Of the codes weight for the procedure by the ASC established methodologies, with the requested for addition to the ASC list, conversion factor for that same year to exception of device removal procedures.
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For CY 2014, we finalized a policy to of the device-intensive procedures using latest hospital outpatient and ASC conditionally package payment for the ASC standard rate setting claims data used for this final rule with device removal codes under the OPPS. methodology and the payment amount comment period, we are updating ASC Under the OPPS, a conditionally for the device portion based on the payment rates for CY 2018 using the packaged code (status indicators ‘‘Q1’’ proposed CY 2018 OPPS device offset established rate calculation and ‘‘Q2’’) describes a HCPCS code percentages that have been calculated methodologies under § 416.171 and where the payment is packaged when it using the standard OPPS APC using our finalized modified definition is provided with a significant procedure ratesetting methodology. Payment for of device-intensive procedures, as but is separately paid when the service office-based procedures would be at the discussed in section XII.C.1.b. of this appears on the claim without a lesser of the proposed CY 2018 MPFS final rule with comment period. We do significant procedure. Because ASC nonfacility PE RVU-based amount or the not generally make additional payment services always include a covered proposed CY 2018 ASC payment adjustments to specific procedures. surgical procedure, HCPCS codes that amount calculated according to the ASC After consideration of the public are conditionally packaged under the standard ratesetting methodology. comments we received, we are OPPS are always packaged (payment As we did for CYs 2014 through 2017, finalizing our proposed policies, indicator ‘‘N1’’) under the ASC payment for CY 2018, we proposed to continue without modification, to calculate the system. Under the OPPS, device our policy for device removal CY 2018 payment rates for ASC covered removal procedures are conditionally procedures, such that device removal surgical procedures according to our packaged and, therefore, would be procedures that are conditionally established methodologies using the packaged under the ASC payment packaged in the OPPS (status indicators modified definition of device-intensive system. There would be no Medicare ‘‘Q1’’ and ‘‘Q2’’) would be assigned the procedures. For those covered office- payment made when a device removal current ASC payment indicators based surgical procedures where the procedure is performed in an ASC associated with these procedures and payment rate is the lower of the final without another surgical procedure would continue to be paid separately rates under the ASC standard ratesetting included on the claim; therefore, no under the ASC payment system. methodology and the MPFS nonfacility Medicare payment would be made if a We invited public comments on these PE RVU-based amount, the final device was removed but not replaced. proposals. payment indicators and rates set forth in To address this concern, for the device Comment: A few commenters this final rule with comment period are removal procedures that are objected to the proposed payment based on a comparison using the MPFS conditionally packaged in the OPPS indicator of ‘‘G2’’ (Non-office-based PE RVUs and conversion factor effective (status indicator ‘‘Q2’’), we assigned the surgical procedure) for CPT code 0465T January 1, 2018. For a discussion of the current ASC payment indicators (Suprachoroidal injection of a MPFS rates, we refer readers to the CY associated with these procedures and pharmacologic agent (does not include 2018 MPFS final rule with comment continued to provide separate payment supply of medication)) and requested period. since CY 2014. that CMS designate it an office-based procedure. The commenters noted CMS’ 2. Payment for Covered Ancillary b. Update to ASC Covered Surgical Services Procedure Payment Rates for CY 2018 recognition of CPT code 0465T as an office-based procedure in the CY 2017 a. Background In the CY 2018 OPPS/ASC proposed OPPS/ASC final rule with comment rule (82 FR 33663), we proposed to Our payment policies under the ASC period (81 FR 79735). payment system for covered ancillary update ASC payment rates for CY 2018 Response: We agree with the services vary according to the particular and subsequent years using the commenters that CPT code 0465T is an type of service and its payment policy established rate calculation office-based procedure. Therefore, we under the OPPS. Our overall policy methodologies under § 416.171 and are modifying our proposal to assign provides separate ASC payment for using our definition of device-intensive CPT code 0465T to payment indicator certain ancillary items and services procedures, as discussed in section ‘‘R2’’ for CY 2018. integrally related to the provision of XII.C.1.b. of the proposed rule. Because Comment: One commenter requested ASC covered surgical procedures that the proposed OPPS relative payment that CMS use the CY 2016 ASC payment are paid separately under the OPPS and weights are based on geometric mean rates for six procedures to set the CY provides packaged ASC payment for costs, the ASC system would use 2018 ASC payment rate for the same other ancillary items and services that geometric means to determine proposed procedures. The specific procedures are packaged or conditionally packaged relative payment weights under the ASC include: standard methodology. We proposed to • CPT 62321 (Cervicothoracic (status indicators ‘‘N’’, ‘‘Q1’’, and ‘‘Q2’’) continue to use the amount calculated epidural); under the OPPS. In the CY 2013 OPPS/ under the ASC standard ratesetting • CPT 62323 (Lumbosacral epidural); ASC rulemaking (77 FR 45169 and 77 methodology for procedures assigned • CPT 64490 (Cervicothoracic facet FR 68457 through 68458), we further payment indicators ‘‘A2’’ and ‘‘G2’’. joint injection); clarified our policy regarding the We proposed to calculate payment • CPT 64493 (Lumbosacral facet joint payment indicator assignment of codes rates for office-based procedures injection); that are conditionally packaged in the (payment indicators ‘‘P2’’, ‘‘P3’’, and • CPT G0620 (Sacroiliac joint OPPS (status indicators ‘‘Q1’’ and ‘‘R2’’) and device-intensive procedures injection); and ‘‘Q2’’). Under the OPPS, a conditionally (payment indicator ‘‘J8’’) according to • CPT 62264 (Percutaneous packaged code describes a HCPCS code our established policies and, for device- adhesiolysis). where the payment is packaged when it intensive procedures, using our Response: We are required by law to is provided with a significant procedure modified definition of device-intensive review and update the data on which but is separately paid when the service procedures, as discussed in section we establish payment rates on an annual appears on the claim without a XII.C.1.b. of the proposed rule. basis. The ASC payment is dependent significant procedure. Because ASC Therefore, we proposed to update the upon the APC assignment for the services always include a surgical payment amount for the service portion procedure. Based on our analysis of the procedure, HCPCS codes that are
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conditionally packaged under the OPPS under the OPPS. These categories do not include a reference to diagnostic are always packaged (payment indictor have prospectively established ASC services and those for which the ‘‘N1’’) under the ASC payment system payment rates according to ASC payment is based on the MPFS (except for device removal codes, as payment system policies (72 FR 42502 nonfacility PE RVU-based amount be discussed in section IV. of the CY 2018 and 42508 through 42509; 42 CFR assigned payment indicator ‘‘Z3,’’ and OPPS/ASC proposed rule). Thus, our 416.164(b)). Under the ASC payment revised the definition of payment policy generally aligns ASC payment system, we have designated corneal indicator ‘‘Z3’’ to include a reference to bundles with those under the OPPS (72 tissue acquisition and hepatitis B diagnostic services. FR 42495). In all cases, in order for vaccines as contractor-priced. Corneal those ancillary services also to be paid, tissue acquisition is contractor-priced b. Payment for Covered Ancillary ancillary items and services must be based on the invoiced costs for Services for CY 2018 provided integral to the performance of acquiring the corneal tissue for In the CY 2018 OPPS/ASC proposed ASC covered surgical procedures for transplantation. Hepatitis B vaccines are rule (82 FR 33663), for CY 2018 and which the ASC bills Medicare. contractor-priced based on invoiced subsequent years, we proposed to Our ASC payment policies provide costs for the vaccine. update the ASC payment rates and to separate payment for drugs and Devices that are eligible for pass- make changes to ASC payment biologicals that are separately paid through payment under the OPPS are indicators, as necessary, to maintain under the OPPS at the OPPS rates. We separately paid under the ASC payment consistency between the OPPS and ASC generally pay for separately payable system and are contractor-priced. Under payment system regarding the packaged radiology services at the lower of the the revised ASC payment system (72 FR or separately payable status of services MPFS nonfacility PE RVU-based (or 42502), payment for the surgical and the proposed CY 2018 OPPS and technical component) amount or the procedure associated with the pass- ASC payment rates and subsequent year rate calculated according to the ASC through device is made according to our payment rates. We also proposed to standard ratesetting methodology (72 FR standard methodology for the ASC continue to set the CY 2018 ASC 42497). However, as finalized in the CY payment system, based on only the payment rates and subsequent year 2011 OPPS/ASC final rule with service (non-device) portion of the payment rates for brachytherapy sources comment period (75 FR 72050), procedure’s OPPS relative payment and separately payable drugs and payment indicators for all nuclear weight if the APC weight for the biologicals equal to the OPPS payment medicine procedures (defined as CPT procedure includes other packaged rates for CY 2018 and subsequent year codes in the range of 78000 through device costs. We also refer to this payment rates. 78999) that are designated as radiology methodology as applying a ‘‘device Covered ancillary services and their services that are paid separately when offset’’ to the ASC payment for the proposed payment indicators for CY provided integral to a surgical associated surgical procedure. This 2018 were listed in Addendum BB to procedure on the ASC list are set to ensures that duplicate payment is not the proposed rule (which is available ‘‘Z2’’ so that payment is made based on provided for any portion of an via the Internet on the CMS Web site). the ASC standard ratesetting implanted device with OPPS pass- For those covered ancillary services methodology rather than the MPFS through payment status. where the payment rate is the lower of nonfacility PE RVU amount (‘‘Z3’’), In the CY 2015 OPPS/ASC final rule the proposed rates under the ASC regardless of which is lower. with comment period (79 FR 66933 standard rate setting methodology and Similarly, we also finalized our policy through 66934), we finalized that, the MPFS proposed rates, the proposed to set the payment indicator to ‘‘Z2’’ for beginning in CY 2015, certain diagnostic payment indicators and rates set forth in radiology services that use contrast tests within the medicine range of CPT the proposed rule were based on a agents so that payment for these codes for which separate payment is comparison using the proposed MPFS procedures will be based on the OPPS allowed under the OPPS are covered rates effective January 1, 2018. For a relative payment weight using the ASC ancillary services when they are integral discussion of the MPFS rates, we standard ratesetting methodology and, to an ASC covered surgical procedure. referred readers to the CY 2018 MPFS therefore, will include the cost for the We finalized that diagnostic tests within proposed rule that is available on the contrast agent (42 CFR 416.171(d)(2)). the medicine range of CPT codes CMS Web site at: https://www.cms.gov/ ASC payment policy for include all Category I CPT codes in the Medicare/Medicare-Fee-for-Service- brachytherapy sources mirrors the medicine range established by CPT, Payment/PhysicianFeeSched/PFS- payment policy under the OPPS. ASCs from 90000 to 99999, and Category III Federal-Regulation-Notices.html. are paid for brachytherapy sources CPT codes and Level II HCPCS codes We did not receive public comments provided integral to ASC covered that describe diagnostic tests that on our proposals regarding payment for surgical procedures at prospective rates crosswalk or are clinically similar to covered ancillary services. Therefore, adopted under the OPPS or, if OPPS procedures in the medicine range we are finalizing these policies as rates are unavailable, at contractor- established by CPT. In the CY 2015 proposed for CY 2018. priced rates (72 FR 42499). Since OPPS/ASC final rule with comment December 31, 2009, ASCs have been period, we also finalized our policy to E. New Technology Intraocular Lenses paid for brachytherapy sources provided pay for these tests at the lower of the (NTIOLs) integral to ASC covered surgical MPFS nonfacility PE RVU-based (or procedures at prospective rates adopted technical component) amount or the 1. NTIOL Application Cycle under the OPPS. rate calculated according to the ASC Our process for reviewing Our ASC policies also provide standard ratesetting methodology (79 FR applications to establish new classes of separate payment for: (1) Certain items 66933 through 66934). We finalized that NTIOLs is as follows: and services that CMS designates as the diagnostic tests for which the • Applicants submit their NTIOL contractor-priced, including, but not payment is based on the ASC standard requests for review to CMS by the limited to, the procurement of corneal ratesetting methodology be assigned to annual deadline. For a request to be tissue; and (2) certain implantable items payment indicator ‘‘Z2’’ and revised the considered complete, we require that have pass-through payment status definition of payment indicator ‘‘Z2’’ to submission of the information that is
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found in the guidance document for CY 2018. The final ASC payment indicator with respect to the timeframe entitled ‘‘Application Process and adjustment amount for NTIOLs for CY when comments will be accepted. The Information Requirements for Requests 2018 is $50. comment indicator ‘‘NP’’ is used in the for a New Class of New Technology OPPS/ASC proposed rule to indicate 4. Announcement of CY 2019 Deadline Intraocular Lenses (NTIOLs) or new codes for the next calendar year for for Submitting Requests for CMS Inclusion of an IOL in an Existing which the interim payment indicator Review of Applications for a New Class NTIOL Class’’ posted on the CMS Web assigned is subject to comment. The of NTIOLs site at: http://www.cms.gov/Medicare/ comment indicator ‘‘NP’’ also is Medicare-Fee-for-Service-Payment/ In accordance with § 416.185(a) of our assigned to existing codes with ASCPayment/NTIOLs.html. regulations, CMS announces that in substantial revisions to their • We announce annually, in the order to be considered for payment descriptors, such that we consider them proposed rule updating the ASC and effective beginning in CY 2019, requests to be describing new services, as OPPS payment rates for the following for review of applications for a new discussed in the CY 2010 OPPS/ASC calendar year, a list of all requests to class of new technology IOLs must be final rule with comment period (74 FR establish new NTIOL classes accepted received at CMS by 5:00 p.m. EST, on 60622). In the CY 2017 OPPS/ASC final for review during the calendar year in March 1, 2018. Send requests to ASC/ rule with comment period, we which the proposal is published. In NTIOL, Division of Outpatient Care, responded to public comments and accordance with section 141(b)(3) of Mailstop C4–05–17, Centers for finalized the ASC treatment of all codes Public Law 103–432 and our regulations Medicare and Medicaid Services, 7500 that were labeled with comment at 42 CFR 416.185(b), the deadline for Security Boulevard, Baltimore, MD indicator ‘‘NP’’ in Addenda AA and BB receipt of public comments is 30 days 21244–1850. To be considered, requests to the CY 2016 OPPS/ASC final rule following publication of the list of for NTIOL reviews must include the with comment period (80 FR 70497). requests in the proposed rule. information requested on the CMS Web The ‘‘CH’’ comment indicator is used • In the final rule updating the ASC site at: https://www.cms.gov/Medicare/ in Addenda AA and BB to the proposed and OPPS payment rates for the Medicare-Fee-for-Service-Payment/ rule (which are available via the Internet following calendar year, we— ASCPayment/NTIOLs.html. on the CMS Web site) to indicate that ++ Provide a list of determinations the payment indicator assignment has made as a result of our review of all new F. ASC Payment and Comment changed for an active HCPCS code in NTIOL class requests and public Indicators the current year and the next calendar comments; 1. Background year; an active HCPCS code is newly ++ When a new NTIOL class is recognized as payable in ASCs; or an In addition to the payment indicators created, identify the predominant active HCPCS code is discontinued at that we introduced in the August 2, characteristic of NTIOLs in that class the end of the current calendar year. 2007 final rule, we created final that sets them apart from other IOLs The ‘‘CH’’ comment indicators that are comment indicators for the ASC (including those previously approved as published in the final rule with payment system in the CY 2008 OPPS/ members of other expired or active comment period are provided to alert ASC final rule with comment period (72 NTIOL classes) and that is associated readers that a change has been made FR 66855). We created Addendum DD1 with an improved clinical outcome. from one calendar year to the next, but ++ Set the date of implementation of to define ASC payment indicators that do not indicate that the change is a payment adjustment in the case of we use in Addenda AA and BB to subject to comment. approval of an IOL as a member of a provide payment information regarding In the CY 2017 OPPS/ASC final rule new NTIOL class prospectively as of 30 covered surgical procedures and with comment period (81 FR 79748 days after publication of the ASC covered ancillary services, respectively, through 79749), for CY 2017 and payment update final rule, consistent under the revised ASC payment system. subsequent years, we finalized our with the statutory requirement. The ASC payment indicators in policy to continue using the current ++ Announce the deadline for Addendum DD1 are intended to capture comment indicators of ‘‘NP’’ and ‘‘CH’’. submitting requests for review of an policy-relevant characteristics of HCPCS codes that may receive packaged or 2. ASC Payment and Comment application for a new NTIOL class for Indicators the following calendar year. separate payment in ASCs, such as whether they were on the ASC list of As discussed in the CY 2018 OPPS/ 2. Requests To Establish New NTIOL covered services prior to CY 2008; ASC proposed rule (82 FR 33665), for Classes for CY 2018 payment designation, such as device- CY 2018, there are proposed new and We did not receive any requests for intensive or office-based, and the revised Category I and III CPT codes as review to establish a new NTIOL class corresponding ASC payment well as new and revised Level II HCPCS for CY 2018 by March 1, 2017, the due methodology; and their classification as codes. Therefore, proposed Category I date published in the CY 2017 OPPS/ separately payable ancillary services, and III CPT codes that are new and ASC final rule with comment period (81 including radiology services, revised for CY 2017 and any new and FR 79748). brachytherapy sources, OPPS pass- existing Level II HCPCS codes with through devices, corneal tissue substantial revisions to the code 3. Payment Adjustment acquisition services, drugs or descriptors for CY 2018 compared to the The current payment adjustment for a biologicals, or NTIOLs. CY 2017 descriptors that were included 5-year period from the implementation We also created Addendum DD2 that in ASC Addenda AA and BB to the date of a new NTIOL class is $50 per lists the ASC comment indicators. The proposed rule are labeled with proposed lens. Since implementation of the ASC comment indicators used in new comment indicator ‘‘NP’’ to process for adjustment of payment Addenda AA and BB to the proposed indicate that these CPT and Level II amounts for NTIOLs in 1999, we have rules and final rules with comment HCPCS codes were open for comment as not revised the payment adjustment period serve to identify, for the revised part of the proposed rule. Comment amount, and we did not propose to ASC payment system, the status of a indicator ‘‘NP’’ in the proposed rule revise the payment adjustment amount specific HCPCS code and its payment meant a new code for the next calendar
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year or an existing code with substantial FR 42532 through 42533; 42 CFR system accounts for geographic wage revision to its code descriptor in the 416.171(e)). variation when calculating individual next calendar year, as compared to We note that we consider the term ASC payments by applying the pre-floor current calendar year; and denotes that ‘‘expenditures’’ in the context of the and pre-reclassified IPPS hospital wage comments will be accepted on the budget neutrality requirement under indexes to the labor-related share, proposed ASC payment indicator for the section 1833(i)(2)(D)(ii) of the Act to which is 50 percent of the ASC payment new code. mean expenditures from the Medicare amount based on a GAO report of ASC We stated in the proposed rule that Part B Trust Fund. We do not consider costs using 2004 survey data. Beginning we will respond to public comments on expenditures to include beneficiary in CY 2008, CMS accounted for ASC payment and comment indicators coinsurance and copayments. This geographic wage variation in labor costs and finalize their ASC assignment in the distinction was important for the CY when calculating individual ASC CY 2018 OPPS/ASC final rule with 2008 ASC budget neutrality model that payments by applying the pre-floor and comment period. We referred readers to considered payments across the OPPS, pre-reclassified hospital wage index Addenda DD1 and DD2 to the proposed ASC, and MPFS payment systems. values that CMS calculates for payment rule (which are available via the Internet However, because coinsurance is almost under the IPPS, using updated Core on the CMS Web site) for the complete always 20 percent for ASC services, this Based Statistical Areas (CBSAs) issued list of ASC payment and comment interpretation of expenditures has by OMB in June 2003. indicators proposed for the CY 2018 minimal impact for subsequent budget The reclassification provision in update. neutrality adjustments calculated within section 1886(d)(10) of the Act is specific We did not receive any public the revised ASC payment system. to hospitals. We believe that using the comments on the ASC payment and In the CY 2008 OPPS/ASC final rule most recently available pre-floor and comment indicators. Therefore, we are with comment period (72 FR 66857 pre-reclassified IPPS hospital wage finalizing their use as proposed without through 66858), we set out a step-by- indexes results in the most appropriate modification. Addenda DD1 and DD2 to step illustration of the final budget adjustment to the labor portion of ASC this final rule with comment period neutrality adjustment calculation based costs. We continue to believe that the (which are available via the Internet on on the methodology finalized in the unadjusted hospital wage indexes, the CMS Web site) contain the complete August 2, 2007 final rule (72 FR 42521 which are updated yearly and are used list of ASC payment and comment through 42531) and as applied to by many other Medicare payment indicators for the CY 2018 update. updated data available for the CY 2008 systems, appropriately account for OPPS/ASC final rule with comment geographic variation in labor costs for G. Calculation of the ASC Conversion period. The application of that ASCs. Therefore, the wage index for an Factor and the ASC Payment Rates methodology to the data available for ASC is the pre-floor and pre-reclassified 1. Background the CY 2008 OPPS/ASC final rule with hospital wage index under the IPPS of comment period resulted in a budget the CBSA that maps to the CBSA where In the August 2, 2007 final rule (72 FR neutrality adjustment of 0.65. the ASC is located. 42493), we established our policy to For CY 2008, we adopted the OPPS On February 28, 2013, OMB issued base ASC relative payment weights and relative payment weights as the ASC OMB Bulletin No. 13–01, which payment rates under the revised ASC relative payment weights for most provides the delineations of all payment system on APC groups and the services and, consistent with the final Metropolitan Statistical Areas, OPPS relative payment weights. policy, we calculated the CY 2008 ASC Metropolitan Divisions, Micropolitan Consistent with that policy and the payment rates by multiplying the ASC Statistical Areas, Combined Statistical requirement at section 1833(i)(2)(D)(ii) relative payment weights by the final Areas, and New England City and Town of the Act that the revised payment CY 2008 ASC conversion factor of Areas in the United States and Puerto system be implemented so that it would $41.401. For covered office-based Rico based on the standards published be budget neutral, the initial ASC surgical procedures, covered ancillary on June 28, 2010 in the Federal Register conversion factor (CY 2008) was radiology services (excluding covered (75 FR 37246 through 37252) and 2010 calculated so that estimated total ancillary radiology services involving Census Bureau data. (A copy of this Medicare payments under the revised certain nuclear medicine procedures or bulletin may be obtained at: https:// ASC payment system in the first year involving the use of contrast agents, as www.whitehouse.gov/sites/ would be budget neutral to estimated discussed in section XII.D.2. of this final whitehouse.gov/files/omb/bulletins/ total Medicare payments under the prior rule with comment period), and certain 2013/b13-01.pdf). In the FY 2015 IPPS/ (CY 2007) ASC payment system (the diagnostic tests within the medicine LTCH PPS final rule (79 FR 49951 ASC conversion factor is multiplied by range that are covered ancillary services, through 49963), we implemented the the relative payment weights calculated the established policy is to set the use of the CBSA delineations issued by for many ASC services in order to payment rate at the lower of the MPFS OMB in OMB Bulletin 13–01 for the establish payment rates). That is, unadjusted nonfacility PE RVU-based IPPS hospital wage index beginning in application of the ASC conversion factor amount or the amount calculated using FY 2015. In the CY 2015 OPPS/ASC was designed to result in aggregate the ASC standard ratesetting final rule with comment period (79 FR Medicare expenditures under the methodology. Further, as discussed in 66937), we finalized a 1-year transition revised ASC payment system in CY the CY 2008 OPPS/ASC final rule with policy that we applied in CY 2015 for 2008 being equal to aggregate Medicare comment period (72 FR 66841 through all ASCs that experienced any decrease expenditures that would have occurred 66843), we also adopted alternative in their actual wage index exclusively in CY 2008 in the absence of the revised ratesetting methodologies for specific due to the implementation of the new system, taking into consideration the types of services (for example, device- OMB delineations. This transition does cap on ASC payments in CY 2007, as intensive procedures). not apply in CY 2018. required under section 1833(i)(2)(E) of As discussed in the August 2, 2007 Generally, OMB issues major the Act (72 FR 42522). We adopted a final rule (72 FR 42517 through 42518) revisions to statistical areas every 10 policy to make the system budget and as codified at § 416.172(c) of the years, based on the results of the neutral in subsequent calendar years (72 regulations, the revised ASC payment decennial census. However, OMB
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occasionally issues minor updates and index data that could be used to set the payment weights between CY 2017 and revisions to statistical areas in the years wage index for that area, we determine CY 2018. We proposed to use the ratio between the decennial censuses. On the ASC wage index by calculating the of CY 2017 to CY 2018 total payments July 15, 2015, OMB issued OMB average of all wage indexes for urban (the weight scalar) to scale the ASC Bulletin No. 15–01, which provides areas in the State (75 FR 72058 through relative payment weights for CY 2018. updates to and supersedes OMB 72059). (In other situations, where there The proposed CY 2018 ASC weight Bulletin No. 13–01 that was issued on are no IPPS hospitals located in a scalar was 0.8995 and scaling would February 28, 2013. The attachment to relevant labor market area, we continue apply to the ASC relative payment OMB Bulletin No. 15–01 provides our current policy of calculating an weights of the covered surgical detailed information on the update to urban or rural area’s wage index by procedures, covered ancillary radiology statistical areas since February 28, 2013. calculating the average of the wage services, and certain diagnostic tests The updates provided in OMB Bulletin indexes for CBSAs (or metropolitan within the medicine range of CPT codes, No. 15–01 are based on the application divisions where applicable) that are which are covered ancillary services for of the 2010 Standards for Delineating contiguous to the area with no wage which the ASC payment rates are based Metropolitan and Micropolitan index.) on OPPS relative payment weights. Statistical Areas to Census Bureau Comment: A few commenters made Scaling would not apply in the case population estimates for July 1, 2012 the same recommendation that was of ASC payment for separately payable and July 1, 2013. The complete list of made in the CY 2010 (74 FR 60625), CY covered ancillary services that have a statistical areas incorporating these 2011 (75 FR 72059), CY 2012 (76 FR predetermined national payment changes is provided in the attachment to 74446), CY 2013 (77 FR 68463), CY 2014 amount (that is, their national ASC OMB Bulletin No. 15–01. According to (78 FR 75086), CY 2015 (79 FR 66937), payment amounts are not based on OMB, ‘‘[t]his bulletin establishes revised CY 2016 (80 FR 70499), and CY 2017 OPPS relative payment weights), such delineations for the Nation’s (81 FR 79750) OPPS/ASC rulemakings— as drugs and biologicals that are Metropolitan Statistical Areas, that is, that CMS adopt for the ASC separately paid or services that are Micropolitan Statistical Areas, and payment system the same wage index contractor-priced or paid at reasonable Combined Statistical Areas. The bulletin values used for hospital payment under cost in ASCs. Any service with a also provides delineations of the OPPS. predetermined national payment Metropolitan Divisions as well as Response: We have responded to this amount would be included in the ASC delineations of New England City and comment in the prior OPPS/ASC rules budget neutrality comparison, but Town Areas.’’ A copy of this bulletin mentioned above, and believe our prior scaling of the ASC relative payment may be obtained on the Web site at: rationale for using unadjusted wage weights would not apply to those https://www.whitehouse.gov/sites/ indexes is still sound. We continue to services. The ASC payment weights for whitehouse.gov/files/omb/bulletins/ believe that the unadjusted hospital those services without predetermined 2015/15-01.pdf. wage indexes, which are updated yearly national payment amounts (that is, OMB Bulletin No. 15–01 made and are used by almost all Medicare those services with national payment changes that are relevant to the IPPS payment systems, appropriately account amounts that would be based on OPPS and ASC wage index. We refer readers for geographic variance in labor costs for relative payment weights) would be to the CY 2017 OPPS/ASC final rule ASCs. We refer readers to our response scaled to eliminate any difference in the with comment period (81 FR 79750) for to this comment in the CY 2011 OPPS/ total payment between the current year a discussion of these changes and our ASC final rule with comment period (75 and the update year. For any given year’s ratesetting, we implementation of these revisions. FR 72059). As discussed in the CY 2018 OPPS/ typically use the most recent full ASC proposed rule (82 FR 33667), for 2. Calculation of the ASC Payment Rates calendar year of claims data to model CY 2018, the proposed CY 2018 ASC a. Updating the ASC Relative Payment budget neutrality adjustments. At the wage indexes fully reflect the OMB Weights for CY 2018 and Future Years time of the proposed rule, we had labor market area delineations available 98 percent of CY 2016 ASC (including the revisions to the OMB We update the ASC relative payment claims data. labor market delineations discussed weights each year using the national To create an analytic file to support above, as set forth in OMB Bulletin No. OPPS relative payment weights (and calculation of the weight scalar and 15–01). MPFS nonfacility PE RVU-based budget neutrality adjustment for the We note that, in certain instances, amounts, as applicable) for that same wage index (discussed below), we there might be urban or rural areas for calendar year and uniformly scale the summarized available CY 2016 ASC which there is no IPPS hospital that has ASC relative payment weights for each claims by ASC and by HCPCS code. We wage index data that could be used to update year to make them budget used the National Provider Identifier for set the wage index for that area. For neutral (72 FR 42533). Consistent with the purpose of identifying unique ASCs these areas, our policy has been to use our established policy, in the CY 2018 within the CY 2016 claims data. We the average of the wage indexes for OPPS/ASC proposed rule (82 FR 33667), used the supplier zip code reported on CBSAs (or metropolitan divisions as we proposed to scale the CY 2018 the claim to associate State, county, and applicable) that are contiguous to the relative payment weights for ASCs CBSA with each ASC. This file, area that has no wage index (where according to the following method. available to the public as a supporting ‘‘contiguous’’ is defined as sharing a Holding ASC utilization, the ASC data file for the proposed rule, is posted border). For example, for CY 2014, we conversion factor, and the mix of on the CMS Web site at: http:// applied a proxy wage index based on services constant from CY 2016, we www.cms.gov/Research-Statistics-Data- this methodology to ASCs located in proposed to compare the total payment and-Systems/Files-for-Order/ CBSA 25980 (Hinesville-Fort Stewart, using the CY 2017 ASC relative LimitedDataSets/ GA) and CBSA 08 (Rural Delaware). payment weights with the total payment ASCPaymentSystem.html. When all of the areas contiguous to using the CY 2018 ASC relative Comment: Several commenters the urban CBSA of interest are rural and payment weights to take into account requested that CMS not scale the ASC there is no IPPS hospital that has wage the changes in the OPPS relative relative payment weights when
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calculating the final CY 2018 ASC system and subsequent years, in the CY Act by adding a new clause (v), which payment rates. Some commenters 2017 OPPS/ASC final rule with requires that any annual update under requested that if CMS must apply a comment period (81 FR 79751 through the ASC payment system for the year, weight scalar, as an alternative, CMS 79753), we finalized our policy to after application of clause (iv), shall be make a one-time adjustment to restore calculate and apply a budget neutrality reduced by the productivity adjustment the historical relativity between the adjustment to the ASC conversion factor described in section 1886(b)(3)(B)(xi)(II) OPPS and ASC setting at 65 percent. for supplier level changes in wage index of the Act, effective with the calendar Response: We note that applying the values for the upcoming year, just as the year beginning January 1, 2011. The weight scalar in calculation of ASC OPPS wage index budget neutrality statute defines the productivity payment rates ensures that the ASC adjustment is calculated and applied to adjustment to be equal to the 10-year payment system remains budget neutral. the OPPS conversion factor. For CY moving average of changes in annual For a more detailed discussion on why 2018, we calculated the proposed economy-wide private nonfarm business we apply a budget neutrality adjustment adjustment for the ASC payment system multifactor productivity (MFP) (as to the ASC ratesetting methodology, we by using the most recent CY 2016 claims projected by the Secretary for the 10- refer readers to the August 2, 2007 final data available and estimating the year period ending with the applicable rule (72 FR 42531 through 42533). We difference in total payment that would fiscal year, year, cost reporting period, refer the commenters to that discussion be created by introducing the proposed or other annual period) (the ‘‘MFP for our detailed response in CY 2018 ASC wage indexes. adjustment’’). Clause (iv) of section promulgating the scaling policy that was Specifically, holding CY 2016 ASC 1833(i)(2)(D) of the Act authorizes the initially applied in CY 2009 to maintain utilization, service-mix, and the Secretary to provide for a reduction in budget neutrality of the ASC payment proposed CY 2018 national payment any annual update for failure to report system. The ASC weight scaling rates after application of the weight on quality measures. Clause (v) of methodology is consistent with the scalar constant, we calculated the total section 1833(i)(2)(D) of the Act states OPPS methodology for scaling the adjusted payment using the CY 2017 that application of the MFP adjustment relative payment weights and the ASC wage indexes (which would fully to the ASC payment system may result increased payment differentials between reflect the new OMB delineations) and in the update to the ASC payment the ASC and OPPS payments for the the total adjusted payment using the system being less than zero for a year same services are not, for the most part, proposed CY 2018 ASC wage indexes. and may result in payment rates under attributable to scaling ASC relative We used the 50-percent labor-related the ASC payment system for a year payment weights. With respect to the share for both total adjusted payment being less than such payment rates for relativity between the OPPS and the calculations. We then compared the the preceding year. ASC payment system, we recognize that total adjusted payment calculated with In the CY 2012 OPPS/ASC final rule the relativity has declined from 65 the CY 2017 ASC wage indexes to the with comment period (76 FR 74516), we percent in 2008 to 56 percent in 2017. total adjusted payment calculated with finalized a policy that ASCs begin We believe this change in relativity is the proposed CY 2018 ASC wage submitting data on quality measures for based on a number of factors, including indexes and applied the resulting ratio services beginning on October 1, 2012 the addition of new surgical procedures of 1.0004 (the proposed CY 2018 ASC for the CY 2014 payment determination in both payment settings, packaged wage index budget neutrality under the ASC Quality Reporting payment policies, device-intensive adjustment) to the CY 2017 ASC (ASCQR) Program. In the CY 2013 policies, and the advent of the C–APC conversion factor to calculate the OPPS/ASC final rule with comment policy, which was implemented under proposed CY 2018 ASC conversion period (77 FR 68499 through 68500), we the OPPS effective January 1, 2015, but factor. finalized a methodology to calculate could not be implemented in the ASC Section 1833(i)(2)(C)(i) of the Act reduced national unadjusted payment system, given systems limitations in requires that, if the Secretary has not rates using the ASCQR Program reduced ASC claims processing because ASC updated amounts established under the update conversion factor that would claims are submitted on the professional revised ASC payment system in a apply to ASCs that fail to meet their claim and are not processed by the same calendar year, the payment amounts quality reporting requirements for the system as hospital claims. Further, the shall be increased by the percentage CY 2014 payment determination and absence of cost data from ASCs makes increase in the Consumer Price Index subsequent years. The application of the it difficult to determine what an for all urban consumers (CPI–U), U.S. 2.0 percentage point reduction to the appropriate relativity between the two city average, as estimated by the annual update factor, which currently is payment systems would be. That is, Secretary for the 12-month period the CPI–U, may result in the update to without cost data from ASCs, we are ending with the midpoint of the year the ASC payment system being less than unable to determine precisely how ASC involved. Therefore, the statute does not zero for a year for ASCs that fail to meet costs compare to those of hospitals paid mandate the adoption of any particular the ASCQR Program requirements. We under the OPPS. We note that the update mechanism, but it requires the amended §§ 416.160(a)(1) and 416.171 commenters did not provide any payment amounts to be increased by the to reflect these policies. empirical evidence to support CPI–U in the absence of any update. In accordance with section increasing ASC payment rates relative to Because the Secretary updates the ASC 1833(i)(2)(C)(i) of the Act, before OPPS payment rates. payment amounts annually, we adopted applying the MFP adjustment, the a policy, which we codified at 42 CFR Secretary first determines the b. Updating the ASC Conversion Factor 416.171(a)(2)(ii), to update the ASC ‘‘percentage increase’’ in the CPI–U, Under the OPPS, we typically apply conversion factor using the CPI–U for which we interpret cannot be a negative a budget neutrality adjustment for CY 2010 and subsequent calendar years. percentage. Thus, in the instance where provider level changes, most notably a Therefore, the annual update to the ASC the percentage change in the CPI–U for change in the wage index values for the payment system is the CPI–U (referred a year is negative, we would hold the upcoming year, to the conversion factor. to as the CPI–U update factor). CPI–U update factor for the ASC Consistent with our final ASC payment Section 3401(k) of the Affordable Care payment system to zero. For the CY policy, for the CY 2017 ASC payment Act amended section 1833(i)(2)(D) of the 2014 payment determination and
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subsequent years, under section ASCQR Program requirements. We healthcare facilities within the Medicare 1833(i)(2)(D)(iv) of the Act, we would proposed to reduce the CPI–U update of system.’’ 34 reduce the annual update by 2.0 2.3 percent by 2.0 percentage points for One commenter, a trade association percentage points for an ASC that fails ASCs that do not meet the quality representing several ASCs noted that to submit quality information under the reporting requirements and then apply surgical care in too many markets rules established by the Secretary in the 0.4 percentage point MFP continues to be provided predominantly accordance with section 1833(i)(7) of adjustment. Therefore, we proposed to in hospitals, which the commenter ¥ the Act. Section 1833(i)(2)(D)(v) of the apply a 0.1 percent MFP-adjusted attributed to Medicare’s failure to pay Act, as added by section 3401(k) of the CPI–U update factor to the CY 2017 ASC competitive rates to ASCs. The Affordable Care Act, requires that the conversion factor for ASCs not meeting commenter asserted that this lack of Secretary reduce the annual update the quality reporting requirements. We migration comes at a high price to the factor, after application of any quality also proposed that if more recent data Medicare program, the taxpayers who reporting reduction, by the MFP are subsequently available (for example, fund it, and the beneficiaries who adjustment, and states that application a more recent estimate of the CY 2018 needlessly incur higher out-of-pocket of the MFP adjustment to the annual CPI–U update and MFP adjustment), we expenses. This commenter also noted update factor after application of any would use such data, if appropriate, to that the hospital market basket is quality reporting reduction may result determine the CY 2018 ASC update for comprised of data that reflects the cost in the update being less than zero for a the final rule with comment period. of items and services necessary to year. If the application of the MFP For CY 2018, we proposed to adjust furnish an outpatient surgical adjustment to the annual update factor the CY 2017 ASC conversion factor procedure, such as compensation, after application of any quality reporting ($45.003) by the proposed wage index utilities, labor-related services and non- reduction would result in an MFP- budget neutrality factor of 1.0004 in labor related services. In addition, in adjusted update factor that is less than addition to the MFP-adjusted CPI–U response to the comment solicitation on zero, the resulting update to the ASC update factor of 1.9 percent discussed ASC payment reform (including the payment rates would be negative and above, which resulted in a proposed CY collection of cost data), described later payments would decrease relative to the 2018 ASC conversion factor of $45.876 in this section, this commenter stated its prior year. We refer readers to the CY for ASCs meeting the quality reporting willingness to work with the Secretary 2011 OPPS/ASC final rule with requirements. For ASCs not meeting the to collaborate on ideas and asserted its comment period (75 FR 72062 through quality reporting requirements, we belief that that the same types of costs 72064) for examples of how the MFP proposed to adjust the CY 2017 ASC that apply to the hospital outpatient adjustment is applied to the ASC conversion factor ($45.003) by the department are also present in the ASC, payment system. proposed wage index budget neutrality but that it did not know if they are For the proposed rule, based on IHS factor of 1.0004 in addition to the Global Inc.’s (IGI’s) 2017 first quarter weighted the same. This commenter quality reporting/MFP-adjusted CPI–U welcomed the opportunity to discuss forecast with historical data through the update factor of ¥0.1 percent discussed fourth quarter of 2016, for the 12-month how ASCs might potentially use a above, which resulted in a proposed CY simple, cost-effective survey, perhaps period ending with the midpoint of CY 2018 ASC conversion factor of $44.976. 2018, the CPI–U update was projected to voluntary in nature, that calculates We invited public comments on these expense categories as a percentage of be 2.3 percent. Also, based on IGI’s 2017 proposals. first quarter forecast, the MFP total expenses to help determine the Comment: Numerous commenters adjustment for the period ending with appropriate weights and price proxies urged CMS to update ASC payment the midpoint of CY 2018 was projected for the ASC setting. The commenter rates using the same update factor as to be 0.4 percent. We finalized the noted that ‘‘a complicating factor, hospital outpatient departments, which methodology for calculating the MFP however, remains the heterogeneity of is the IPPS hospital market basket. adjustment in the CY 2011 MPFS final the ASC model—the range of size and Commenters argued that because the rule with comment period (75 FR 73394 specialty care varies greatly from one ASC relative weights are derived from through 73396) and revised it in the CY ASC to the next.’’ the OPPS weights, the same annual 2012 MPFS final rule with comment Commenters also made the following update factor that is used for the OPPS period (76 FR 73300 through 73301) and arguments in support of replacing the should also be used for ASCs. the CY 2016 OPPS/ASC final rule with CPI–U with the hospital market basket: Commenters stated that the use of comment period (80 FR 70500 through • different update indices has contributed The CPI–U does not accurately 70501). represent the costs borne by ASC In the CY 2018 OPPS/ASC proposed to the divergence in payments between the HOPD and ASC setting. Several facilities to furnish surgical services. rule (82 FR 33668), for CY 2018, we Approximately 8.5 percent of the CPI– proposed to reduce the CPI–U update of commenters cited findings from a 2013 Ambulatory Surgery Center Association U inputs are directly related to health 2.3 percent by the MFP adjustment of care, yet the CPI–U is based on 0.4 percentage point, resulting in an (ASCA) study (with cost savings analysis produced by the University of consumer experience purchasing health MFP-adjusted CPI–U update factor of care rather than a provider’s experience 1.9 percent for ASCs meeting the quality California-Berkeley) that found ASCs saved the Medicare program and its necessary to furnish a health care reporting requirements. Therefore, we service. proposed to apply a 1.9 percent MFP- beneficiaries $7.5 billion during the 4- adjusted CPI–U update factor to the CY year period from 2008 to 2011 over what would have been paid if care had been 34 ASCA. Medicare Cost Savings Tied to 2017 ASC conversion factor for ASCs Ambulatory Surgery Centers with Cost Analysis meeting the quality reporting provided in other settings. The study done by Nicholas C. Petris University of California- requirements. The ASCQR Program also projected that ASCs have the Berkeley Center on Health Care Markets and affected payment rates beginning in CY potential to save the Medicare system an Consumer Welfare. September 2013. Available at: additional $57.6 billion over the next http://www.ascassociation.org/HigherLogic/System/ 2014 and, under this program, there is DownloadDocumentFile.ashx?DocumentFileKey= a 2.0 percentage point reduction to the decade ‘‘if policymakers take steps to 7b33b916-f3f1-42e5-a646-35cc2f38fe4d& CPI–U for ASCs that fail to meet the encourage the use of these innovative forceDialog=0.
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• ASCs are one of few remaining Nonetheless, we recognize that ASCs hospitals paid under the OPPS and the Medicare payment systems tied to the may incur some of the same costs that ASC has increased from approximately CPI–U. Most other systems use indices hospitals incur and share the 65 percent in 2008 to approximately 56 derived from the basket of goods those commenters’ concern that the disparity percent in 2017. Accordingly, we plan providers purchase (for example, ESRD in payments between the OPPS and to study this issue further to ensure PPS uses ESRD bundled market basket; ASC payment systems may affect ASCs can continue to offer lower cost FQHC PPS uses Medicare Economic migration from the HOPD setting to the surgical services to Medicare Index; IPPS and OPPS uses the hospital less costly ASC setting. To the extent beneficiaries. market basket). that it is clinically appropriate for a With respect to MedPAC’s comment • The hospital market basket is a beneficiary to receive services in a lower about collecting cost data and comments more accurate reflection of ASC costs cost setting, we believe it would be from ASCs expressing a willingness to because it is comprised of data that appropriate to continue to develop work with CMS to share data in a way reflects the cost of items and services payment incentives and remove that balances administrative risk with necessary to furnish an outpatient payment disincentives to facilitate this the benefit of collecting such data, we surgical procedure, such as choice. We will continue to monitor will take these comments under compensation, utilities, labor-related access to services, such as by reviewing advisement for future consideration, as services and nonlabor-related services. utilization in different settings and discussed in greater detail in the MedPAC objected to the proposed 1.9 soliciting stakeholder input, to ascertain comment solicitation section below. For percent update based on CPI–U and the degree to which choices are the reasons stated above, we are recommended that CMS not update available. While there are several factors finalizing our proposal to use the CPI– payments to ASCs in 2018, consistent that contribute to the divergence in U update factor to update ASC rates for with its recommendation to Congress in payment between the two systems, CY 2018. However, given the many the March 2017 Report to the Congress. certain of which are identified in the comments supporting alternative update MedPAC contended that, because comment solicitation on ASC payment methodologies, such as the hospital indicators of payment adequacy for reform, we believe that an alternative market basket, and given our interest in ASCs—capacity and supply of update factor could be a mitigating step site neutrality and the efficiency of care providers, volume of services, access to to address the differential between in the ASC setting, we intend to explore capital, payment to providers per fee- OPPS and ASC payment. In other this issue further. for-service beneficiary—are positive, words, to the extent that the CPI–U has After consideration of the public and in light of the importance of been lower than the hospital market comments we received, we are maintaining financial pressure on basket, we believe this difference or gap finalizing our proposal to apply our providers to constrain costs, the has contributed to the difference established methodology for proposed 1.9 percent update is between payments for services when determining the final CY 2018 ASC unnecessarily high. While MedPAC they are provided by an ASC or a HOPD. conversion factor. Using more complete acknowledged that the CPI–U likely Additionally, we believe that, in CY 2016 data for this final rule with does not reflect ASC’s cost structure response to our proposal and comment comment period than were available for because the CPI–U is heavily weighted solicitation, commenters have raised an the proposed rule, we calculated a wage for factors that have a relatively small important issue that merits index budget neutrality adjustment of effect on ASCs such as housing and consideration given the 1.0007. Based on IGI’s 2017 third transportation, it commented that it Administration’s priorities, particularly quarter forecast, the CPI–U for the 12- understood that the method for arriving those seeking to promote and improve month period ending with the midpoint at the proposed 1.9 percent CPI–U affordability and accessibility of care. of CY 2018 is now projected to be 1.7 update is mandated by law. MedPAC For example, under Executive Order percent, while the MFP adjustment (as strongly urged CMS to collect cost data 13813 (issued October 12, 2017), discussed in the CY 2011 MPFS final from ASCs to better assess payment entitled ‘‘Presidential Executive Order rule with comment period (75 FR 73394 adequacy to ASCs. Promoting Healthcare Choice and through 73396), and revised in the CY Response: As we have stated in Competition Across the United States,’’ 2012 MPFS final rule with comment response to similar comments in the ‘‘it shall be the policy of the executive period (76 FR 73300 through 73301) and past (for example, 77 FR 68465; 78 FR branch, to the extent consistent with in the CY 2016 OPPS/ASC final rule 75088 through 75089; 79 FR 66939; 80 law, to facilitate . . . the development with comment period (80 FR 70500 FR 70501; and 81 FR 79752), we and operation of a healthcare system through 70501)) is 0.5 percent, resulting continue to believe that, while that provides high-quality care at in an MFP-adjusted CPI–U update factor commenters believed that the items affordable prices for the American of 1.2 percent for ASCs that meet the included in the CPI–U index may not people’’ and the Administration shall quality reporting requirements. The adequately measure inflation for the ‘‘continue to focus on promoting final ASC conversion factor of $45.575, goods and services provided by ASCs, competition in healthcare markets and for ASCs that meet the quality reporting the hospital market basket may also not limiting excessive consolidation requirements, is the product of the CY be well aligned with the cost structures throughout the healthcare system.’’ 35 2017 conversion factor of $45.003 of ASCs. While there are some While MedPAC recommends a zero multiplied by the wage index budget similarities between the cost structure of percent update, we do not believe that neutrality adjustment of 1.0007 and the hospitals and ASCs, hospitals provide a such update would serve to promote MFP-adjusted CPI–U payment update of wider range of services, such as room competition in health care markets and 1.2 percent. For ASCs that do not meet and board and emergency services, and it could hinder ASCs’ ability to provide the quality reporting requirements, we the costs associated with providing services to Medicare beneficiaries at a are reducing the CPI–U update of 1.7 these services do not appear to be part lower cost than HOPDs. We know that percent by 2.0 percentage points and of the ASC cost structure. Therefore, at the differential in payments between then we are applying the 0.5 percentage this time, we do not believe that it is point MFP adjustment, resulting in a ¥ appropriate to use the hospital market 35 Available at: https://www.gpo.gov/fdsys/pkg/ 0.8 percent MFP adjusted CPI–U basket for the ASC annual update. FR-2017-10-17/pdf/2017-22677.pdf. update factor for CY 2018. The final
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ASC conversion factor of $44.663 for furnished in HOPDs paid under the MedPAC conducts an annual review ASCs that do not meet the quality OPPS, including examining the of the ASC payment system and submits reporting requirements is the product of accuracy of the APC codes, with respect its findings and recommendations in a the CY 2017 conversion factor of to surgical procedures furnished in report to Congress. As part of this $45.003 multiplied by the wage index ASCs. On November 30, 2006, the GAO review, MedPAC examines indicators budget neutrality adjustment of 1.0007 published the statutorily mandated such as beneficiaries’ access to care, and the MFP-adjusted CPI–U payment report entitled, ‘‘Medicare: Payment for capacity and supply of providers, and update of ¥0.8 percent. Ambulatory Surgical Centers Should Be volume of services, in part to assess the Based on the Hospital Outpatient adequacy of Medicare payments to 3. Discussion of Comment Solicitation 37 on ASC Payment Reform Payment System’’ (GAO–07–86). As ASCs. Based on its analysis of indicators directed by section 626(d) of Public Law of payment adequacy, in its March 2017 a. Historical Perspective 108–173, the report included Report to Congress, MedPAC found that In 1982, Medicare implemented the recommendations on the following the number of Medicare-certified ASCs ASC benefit to provide payment to issues: had increased, beneficiaries’ use of ASCs to perform certain covered 1. Appropriateness of using groups of ASCs had increased, and access to surgical procedures.36 ASCs were covered services and relative weights capital has been adequate. As a result, recognized by Medicare as a less costly established for the OPPS as the basis of for CY 2018, MedPAC stated that alternative to hospital inpatient care payment for ASCs. payments to ASCs are adequate and given differences in patient acuity and 2. If the OPPS relative weights are recommended that no payment update specialization of services, which appropriate for this purpose, whether should be given for 2018 (that is, the promotes efficient and cost-effective the ASC payments should be based on update factor would be 0 percent). In delivery of care. Medicare’s initial a uniform percentage of the payment addition, MedPAC recommended that payment rates to ASCs were based on rates or weights under the OPPS, or Congress require ASCs to report cost ASC historical cost and charge data should vary, or the weights should be data to enable the Commission to from 1979 and 1980 collected from revised based on specific procedures or examine the growth of ASCs’ costs over approximately 40 ASCs and used to types of services. time and analyze Medicare payments establish four facility payment rate 3. Whether a geographic adjustment relative to the costs of efficient groups (55 FR 4527). should be used for ASC payment and, providers, which would help inform The ASC facility payment rate was set if so, the labor and nonlabor shares of decisions about the ASC update. Also, as a standard overhead amount based on such payment. while MedPAC is concerned that the CMS’ (known then as the Health Care We refer readers to the CY 2008 CPI–U may not reflect ASCs’ cost Financing Administration (HCFA)) OPPS/ASC final rule with comment structure, until cost information is estimate of a fair fee, taking into account period (71 FR 42474) for a detailed available from ASCs, MedPAC cannot the costs incurred by ASCs generally in summary of the GAO’s methodology, determine whether an alternative providing facility services in connection results, and recommendations. Notably, update factor would be more with the performance of a specific based on the findings from the study, appropriate.38 procedure. The Report of the Conference the GAO recommended that CMS Committee accompanying section 934 of implement a payment system for b. Solicitation of Comments the Omnibus Budget Reconciliation Act procedures performed in ASCs based on In the CY 2018 OPPS/ASC proposed of 1980 (Pub. L. 96–499), which enacted the OPPS, taking into account the lower rule (82 FR 33668), we stated that we the ASC benefit in December 1980, relative costs of procedures performed are broadly interested in feedback, states, ‘‘This overhead factor is expected in ASCs compared to HOPDs in including recommendations and ideas to be calculated on a prospective basis determining ASC payment rates. for ASC payment system reform. We . . . utilizing sample survey and similar We considered the report’s recognize that ASCs provide a critically techniques to establish reasonable methodology, findings, and important access point to beneficiaries estimated overhead allowances for each recommendations implementing the who may be too ill or have the need for of the listed procedures which take current ASC payment system, effective too complicated a procedure to be account of volume (within reasonable in 2008 (71 FR 42474). Consistent with treated in the physician office setting, limits)’’ (H.R. Rep. No 7479, 96th Cong., statutory requirements and the GAO’s but for whom hospital care is either not 2nd Sess. 134 (1980)). recommendations, we finalized policies In 1987, we updated the ASC facility medically necessary or undesirable. The to implement a revised ASC payment payment rates for the first time since current ASC payment system was system based on the OPPS resource 1982. The updated rates were based on implemented in 2008 and major costs and relativity of service offerings. the projected increase in the CPI–U from revisions have not been made since that September 1982 to January 1988. CMS The payment system for ASC facility time. Average ASC payment rates have (then, HCFA) rebased payments to ASCs services was designed as a prospective declined relative to OPPS payments in 1990, relying on a survey of 1986 payment system to pay all procedures rates over the past 10 years, from 65 ASC cost, charge, and utilization data. included in an APC a standard rate. percent of average OPPS rates in CY The ASC payments were updated Under a prospective payment system, 2008 to 56 percent (as proposed) of annually based on the 1986 cost data payment is set to reflect the average cost average OPPS rates in CY 2018. until implementation of the revised ASC to furnish a service. That is, some cases However, in the absence of ASC-specific payment system in 2008. may be more costly than the average cost data, it is difficult, if not Congress directed the GAO to conduct while others may be less costly. This impossible, to determine whether ASC a study comparing the relative costs of type of payment system inherently facility payment rates are in line with procedures furnished in ASCs to those provides incentives for each facility to be more efficient. 38 MedPAC. March 2017 Report to Congress. 36 Omnibus Reconciliation Act of 1980 (ORA), Chapter 5 ‘‘Ambulatory Surgical Center Services’’. Public Law 96–499, 934(b), 94 Stat. 2599, 2637 37 Available at: http://www.gao.gov/assets/260/ Available at: http://www.medpac.gov/docs/default- (codified, as amended, at 42 U.S.C. 1395l(i)). 253992.pdf. source/reports/mar17_medpac_ch5.pdf?sfvrsn=0.
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ASC facility resource costs and the to ASC costs for items such as supplies, stakeholder comments on whether impact on beneficiary access to care. drugs, employee compensation, rent, billing on an institutional claim form With respect to the update factor that and other inputs, as compared to those rather than a professional claim form is applied to ASC payments, section of hospitals or physician offices, would address some of the issues 1833(i)(2)(C)(i) of the Act requires that, including qualitative and quantitative affecting ASC payment reform. if the Secretary has not updated the data from ASCs. We stated that As noted earlier in this section, we payment amounts established under the information on the cost structure of stated we were broadly interested in revised ASC payment system in a ASCs will help to identify an feedback from stakeholders and other calendar year, the payment amounts appropriate alternative update factor. interested parties on potential reforms shall be increased by the percentage In addition, we sought public to the current ASC payment system, increase in the Consumer Price Index comments on whether the Secretary including, but not limited to (1) the rate for all urban consumers (CPI–U), (U.S. should collect cost data from ASCs to update factor applied to ASC payments, city average), as estimated by the use in determining ASC payment rates. (2) whether and how ASCs should Secretary for the 12-month period To the extent commenters recommend submit costs, (3) whether ASCs should ending with the midpoint of the year that ASC cost data should be used in the bill on the institutional claim form involved. Therefore, the statute does not determination of ASC payment rates, we rather than the professional claim form, mandate the adoption of any particular sought comments on what specific and (4) other ideas to improve payment update mechanism, except in the method of cost collection commenters accuracy for ASCs. absence of any update, when it requires recommend (such as cost reports or a Comment: Many commenters the payment amounts to be increased by survey). We recognize that the provided detailed comments and their the increase in the CPI–U. submission of costs may be an feedback is summarized below. CMS adopted a policy, codified at 42 administrative burden to ASCs, and we • Rate update factor: The vast CFR 416.171(a)(2)(ii), to update the ASC stated that we were interested in majority of commenters were in favor of conversion factor using the CPI–U for comments that detail how we could applying the hospital market basket to CY 2010 and subsequent calendar years. mitigate the burden of reporting costs on update annual ASC payment. Therefore, the annual update to the ASC ASCs while also collecting enough data Commenters believed that because ASC payment system is the CPI–U (referred to reliably use such data in the provide the types of surgical services as to as the CPI–U update factor). This determination of ASC costs. We noted hospitals that the hospital market basket update factor is adjusted by the that the ability to calculate ASC-specific is the most appropriate index. As an productivity adjustment described in costs may obviate the need for tying the alternative to the hospital market basket, section 1886(b)(3)(B)(xi)(II) of the Act, ASC payment system to that of the one commenter noted that there are as required by section 1833(i)(2)(D)(v) of OPPS. In addition, collecting cost data other indices in the CPI and MEI that the Act. In the CY 2018 OPPS/ASC from ASCs could inform whether an would be suitable to both the OPPS and proposed rule, we solicited comments alternative input price index would be ASC settings; for example, the CPI for on the ASC payment system update an appropriate proxy for ASC costs or medical care. factor and indicated that we are whether an ASC-specific market basket • Collection of cost data: One interested in data from ASCs that would should be developed. commenter stated that the same types of help determine whether the ASC With respect to the ability to adopt costs that apply to HOPDs also apply to payment system should continue to be payment policies that exist under the ASCs, but they may not be weighted the updated by the CPI–U, or by an OPPS into the ASC payment system, as same. The commenter offered to alternative update factor, such as the discussed in prior rulemaking, due to collaborate with CMS on ways to collect hospital market basket, the Medicare differences in the systems used to ASC cost information. For example, a Economic Index, and a blend of update process claims for hospitals and ASCs, simple, cost effective survey, perhaps factors or other mechanism. The we were not able to implement certain voluntary, cost collection tool that hospital market basket update is OPPS payment policies in the ASC calculates expense categories as a typically higher than the CPI–U, while payment system, such as comprehensive percentage of total expenses to help the Medicare Economic Index is APCs, conditional packaging, and the determine the appropriate weights and typically lower. Because the rate update ‘‘FD’’ value modifier for device credits price proxies for the ASC setting. is not applied in a budget neutral (79 FR 66923). ASC facilities report However, the commenter urged CMS to manner, applying a higher update factor services on a professional claim (or be mindful of imposing an excessive would be a cost to the Medicare CMS–1500) rather than an institutional administrative burden. Commenters program while applying a lower update claim (or UB–04) used by hospitals. The representing individual ASCs were factor would result in savings to the ASC claim form is processed in the generally opposed to submitting formal Medicare program. As mentioned above, Medicare Claims System (MCS), the cost reports but expressed a willingness in the absence of an alternative update, same system used to process claims to complete a survey so long as it was the Act requires payments to ASCs to be submitted by physicians and other not administratively burdensome. increased in an amount equal to the clinicians, while hospital claims are MedPAC recommended that CMS percentage increase in the CPI–U. processed through the Fiscal begin collecting new cost data and use With respect to the ASC update, in its Intermediary Shared System (FISS). In that information to examine whether an March 2017 Report to Congress, part, because of differences in the claim existing Medicare price index is an MedPAC stated that ASCs have a much form and the claims processing systems, appropriate proxy for the cost of ASC higher share of expenses for supplies it is not always possible to adopt OPPS facilities or an ASC-specific market and drugs than do hospitals or payment policies into the ASC payment basket should be developed. MedPAC physician offices, a much smaller share system. The resulting divergence in suggested that, to minimize burden on of employee compensation costs than payment policies between the two ASCs and CMS, CMS could require all hospitals, and a smaller share of all systems may contribute to unintended ASCs to submit streamlined cost reports other costs (such as rent) than physician disparities in payment rates for the same or require a random sample of ASCs to offices. In the proposed rule, we sought services. In the CY 2018 proposed rule, respond to annual surveys. For example, public comments on information related we stated that we were interested in MedPAC recommended that CMS
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collect cost data for items such as drugs, standard ratesetting methodology and covered ancillary services that have a medical supplies (including costly the MPFS final rates, the final payment predetermined national payment implantable devices), medical indicators and rates set forth in this amount, such as drugs and biologicals equipment, employee compensation, final rule with comment period are and brachytherapy sources that are building expenses (such as rent), and based on a comparison using the final separately paid under the OPPS, or other professional services (such as MPFS rates that will be effective January services that are contractor-priced or legal, accounting, and billing services). 1, 2018. For a discussion of the MPFS paid at reasonable cost in ASCs. • Billing: One commenter noted that rates, we refer readers to the CY 2018 To derive the final CY 2018 payment the major issues affecting the payment MPFS final rule with comment period. rate displayed in the ‘‘Final CY 2018 differential between the ASC and OPPS The final payment rates included in Payment Rate’’ column, each ASC would not be fixed by billing on an these addenda reflect the full ASC payment weight in the ‘‘Final CY 2018 institutional claim form. payment update and not the reduced Payment Weight’’ column was A few ASC facilities expressed payment update used to calculate multiplied by the final CY 2018 support for requiring ASCs to bill on a payment rates for ASCs not meeting the conversion factor of $45.575. The final UB–04 (institutional claim). These quality reporting requirements under conversion factor includes a budget commenters stated they currently bill on the ASCQR Program. These addenda neutrality adjustment for changes in the a UB–04 for commercial payers and contain several types of information wage index values and the annual would benefit from a consistent claim related to the final CY 2018 payment update factor as reduced by the form across all payers, especially for rates. Specifically, in Addendum AA, a productivity adjustment (as discussed in Medicare crossover claims. One ‘‘Y’’ in the column titled ‘‘To be Subject section XII.G.2.b. of this final rule with commenter noted that billing on a UB– to Multiple Procedure Discounting’’ comment period). 04 ‘‘is not a foreign concept’’ and that indicates that the surgical procedure In Addendum BB, there are no it warranted further exploration by will be subject to the multiple relative payment weights displayed in CMS. A few commenters acknowledged procedure payment reduction policy. As the ‘‘Final CY 2018 Payment Weight’’ that because not all ASCs currently bill discussed in the CY 2008 OPPS/ASC column for items and services with on an UB–04, a transition period would final rule with comment period (72 FR predetermined national payment be necessary to allow for successful 66829 through 66830), most covered amounts, such as separately payable implementation, though a suggested surgical procedures are subject to a 50- drugs and biologicals. The ‘‘Final CY timeframe was not provided. percent reduction in the ASC payment 2018 Payment’’ column displays the MedPAC also recommended that CMS for the lower-paying procedure when final CY 2018 national unadjusted ASC transition ASCs to billing on an UB–04. more than one procedure is performed payment rates for all items and services. MedPAC stated that because the ASC in a single operative session. The final CY 2018 ASC payment rates payment system is closely linked to the Display of the comment indicator listed in Addendum BB for separately OPPS, to fully align OPPS payment ‘‘CH’’ in the column titled ‘‘Comment payable drugs and biologicals are based policies with the ASC payment system, Indicator’’ indicates a change in on ASP data used for payment in ASCs and hospitals should use the same payment policy for the item or service, physicians’ offices in October 2017. claim form. However, MedPAC including identifying discontinued Addendum EE provides the HCPCS suggested that implementation of a HCPCS codes, designating items or codes and short descriptors for surgical requirement to bill on an UB–04 and to services newly payable under the ASC procedures that are to be excluded from submit cost data should be staggered. payment system, and identifying items payment in ASCs for CY 2018. • Payment relativity: Several or services with changes in the ASC XIII. Requirements for the Hospital commenters recommended that CMS payment indicator for CY 2018. Display Outpatient Quality Reporting (OQR) discontinue applying the ‘‘secondary of the comment indicator ‘‘NI’’ in the Program scaling adjustment’’ and instead to column titled ‘‘Comment Indicator’’ apply the OPPS relative weights to ASC indicates that the code is new (or A. Background services. In addition, commenters also substantially revised) and that 1. Overview recommended that CMS restore the comments will be accepted on the historical relativity between the OPPS interim payment indicator for the new CMS seeks to promote higher quality and ASC setting. Some commenters code. Display of the comment indicator and more efficient healthcare for suggested a conservative relativity ‘‘NP’’ in the column titled ‘‘Comment Medicare beneficiaries. Consistent with adjustment of 55 percent while others Indicator’’ indicates that the code is new these goals, CMS has implemented suggested 65 percent (CY 2008 ratio). (or substantially revised) and that quality reporting programs for multiple Response: We will take the feedback comments will be accepted on the ASC care settings including the quality on all of these potential ASC payment payment indicator for the new code. reporting program for hospital reform issues under advisement and The values displayed in the column outpatient care, known as the Hospital consideration for future policymaking. titled ‘‘Final CY 2018 Payment Weight’’ Outpatient Quality Reporting (OQR) are the final relative payment weights Program, formerly known as the 4. Display of CY 2018 ASC Payment for each of the listed services for CY Hospital Outpatient Quality Data Rates 2018. The final relative payment Reporting Program (HOP QDRP). The Addenda AA and BB to this final rule weights for all covered surgical Hospital OQR Program is generally with comment period (which are procedures and covered ancillary aligned with the quality reporting available on the CMS Web site) display services where the ASC payment rates program for hospital inpatient services the final updated ASC payment rates for are based on OPPS relative payment known as the Hospital Inpatient Quality CY 2018 for covered surgical procedures weights were scaled for budget Reporting (IQR) Program (formerly and covered ancillary services, neutrality. Therefore, scaling was not known as the Reporting Hospital respectively. For those covered surgical applied to the device portion of the Quality Data for Annual Payment procedures and covered ancillary device-intensive procedures, services Update (RHQDAPU) Program). services where the payment rate is the that are paid at the MPFS nonfacility PE In addition to the Hospital IQR and lower of the final rates under the ASC RVU-based amount, separately payable Hospital OQR Programs, CMS has
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implemented quality reporting programs As appropriate, we will consider the ethnicity, employment, disability, for other care settings that provide adoption of measures with electronic community resources, and social financial incentives for the reporting of specifications to enable the collection of support (certain factors of which are quality data to CMS. These additional this information for our quality also sometimes referred to as programs include reporting for care programs. socioeconomic status (SES) factors or furnished by: We refer readers to the CY 2013 socio-demographic status (SDS) factors) • Physicians and other eligible OPPS/ASC final rule with comment play a major role in health. One of our professionals, under the Physician period (77 FR 68467 through 68469) for core objectives is to improve beneficiary Quality Reporting System (PQRS, a discussion on the principles outcomes including reducing health formerly referred to as the Physician underlying consideration for future disparities, and we want to ensure that Quality Reporting Program Initiative measures that we intend to use in all beneficiaries, including those with (PQRI)). We note that 2018 is the last implementing this and other quality social risk factors, receive high quality year of the PQRS payment adjustment. reporting programs. We did not propose care. In addition, we seek to ensure that Beginning in 2019, eligible clinicians any changes to these policies. the quality of care furnished by may be subject to upward or downward 2. Statutory History of the Hospital OQR providers and suppliers is assessed as payment adjustments under the Merit- Program fairly as possible under our programs based Incentive Payment System (MIPS) while ensuring that beneficiaries have or be able to earn a positive payment We refer readers to the CY 2011 adequate access to excellent care. incentives through participation in OPPS/ASC final rule with comment We have been reviewing reports certain advanced alternative payment period (75 FR 72064 through 72065) for prepared by the Office of the Assistant models (APMs) under the Quality a detailed discussion of the statutory Secretary for Planning and Evaluation Payment Program (QPP) (81 FR 77008); history of the Hospital OQR Program. (ASPE) 39 and the National Academies • Inpatient rehabilitation facilities, 3. Regulatory History of the Hospital of Sciences, Engineering, and Medicine under the Inpatient Rehabilitation OQR Program on the issue of measuring and Facility Quality Reporting Program (IRF accounting for social risk factors in We refer readers to the CY 2008 QRP); CMS’ value-based purchasing and • Long-term care hospitals, under the through 2017 OPPS/ASC final rules quality reporting programs, and Long-Term Care Hospital Quality with comment period (72 FR 66860 considering options on how to address through 66875; 73 FR 68758 through Reporting Program (LTCH QRP); the issue in these programs. On • PPS-exempt cancer hospitals, under 68779; 74 FR 60629 through 60656; 75 December 21, 2016, ASPE submitted a the PPS-Exempt Cancer Hospital FR 72064 through 72110; 76 FR 74451 Report to Congress on a study it was Quality Reporting (PCHQR) Program; through 74492; 77 FR 68467 through required to conduct under section 2(d) • Ambulatory surgical centers, under 68492; 78 FR 75090 through 75120; 79 of the Improving Medicare Post-Acute the Ambulatory Surgical Center Quality FR 66940 through 66966; 80 FR 70502 Care Transformation (IMPACT) Act of Reporting (ASCQR) Program; through 70526; and 81 FR 79753 2014. The study analyzed the effects of • Inpatient psychiatric facilities, through 79797). We have also codified certain social risk factors of Medicare under the Inpatient Psychiatric Facility certain requirements under the Hospital beneficiaries on quality measures and Quality Reporting (IPFQR) Program; OQR Program at 42 CFR 419.46. In the measures of resource use used in one or • Home health agencies, under the CY 2018 OPPS/ASC proposed rule (82 more of nine Medicare value-based Home Health Quality Reporting Program FR 33671), we proposed editorial purchasing programs.40 The report also (HH QRP); and changes to 42 CFR 419.46, replacing the included considerations for strategies to • Hospices, under the Hospice terms ‘‘Web’’ and ‘‘Web site’’ with the account for social risk factors in these Quality Reporting Program (HQRP). terms ‘‘web’’ and ‘‘Web site,’’ programs. In a January 10, 2017 report In addition, CMS has implemented respectively. released by the National Academies of several value-based purchasing We did not receive any comments on Sciences, Engineering, and Medicine, programs that link payment to our proposal. Therefore, we are that body provided various potential performance, including the Hospital finalizing our changes to 42 CFR 419.46 methods for measuring and accounting Value-Based Purchasing (VBP) Program; as proposed, by replacing the terms for social risk factors, including the Hospital-Acquired Condition (HAC) ‘‘Web’’ and ‘‘Web site’’ with the terms stratified public reporting.41 Reduction Program; and the End-Stage ‘‘web’’ and ‘‘Web site,’’ respectively. As noted in the FY 2017 IPPS/LTCH Renal Disease (ESRD) Quality Incentive B. Hospital OQR Program Quality PPS final rule, the NQF has undertaken Program (QIP); and the Quality Payment Measures a 2-year trial period in which new Program (QPP). measures, measures undergoing In implementing the Hospital OQR 1. Considerations in the Selection of maintenance review, and measures Program and other quality reporting Hospital OQR Program Quality endorsed with the condition that they programs, we have focused on measures Measures enter the trial period can be assessed to that have high impact and support We refer readers to the CY 2012 determine whether risk adjustment for national priorities for improved quality OPPS/ASC final rule with comment selected social risk factors is appropriate and efficiency of care for Medicare period (76 FR 74458 through 74460) for beneficiaries as reflected in the National a detailed discussion of the priorities we 39 Office of the Assistant Secretary for Planning Quality Strategy (NQS) and the CMS consider for the Hospital OQR Program and Evaluation. 2016. Report to Congress: Social Quality Strategy for conditions with Risk Factors and Performance Under Medicare’s quality measure selection. We did not Value-Based Purchasing Programs. Available at: reported wide cost and treatment propose any changes to our measure https://aspe.hhs.gov/pdf-report/report-congress- variations despite established clinical selection policy. social-risk-factors-and-performance-under- treatment guidelines. To the extent medicares-value-based-purchasing-programs. possible under various authorizing 2. Accounting for Social Risk Factors in 40 Ibid. the Hospital OQR Program 41 National Academies of Sciences, Engineering, statutes, our ultimate goal is to align the and Medicine. 2017. Accounting for social risk clinical quality measure requirements of We understand that social risk factors factors in Medicare payment. Washington, DC: The the various quality reporting programs. such as income, education, race and National Academies Press.
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for these measures. This trial entailed data sources where this information commenter supported methodologies temporarily allowing inclusion of social would be available, could be used alone including providing confidential risk factors in the risk-adjustment or in combination, and whether other reporting of stratified measure rates to approach for these measures. Since data should be collected to better providers and risk adjustment of publication of the proposed rule, we capture the effects of social risk. We will measures. Several commenters have learned that the National Quality take commenters’ input into expressed concern with public reporting Forum (NQF) has concluded their initial consideration as we continue to assess of risk adjusted data, while others trial on risk adjustment for quality the appropriateness and feasibility of recommended that publicly reported measures.42 Based on the findings from accounting for social risk factors in the data specifically be risk adjusted. the initial trial, we have been informed Hospital OQR Program. A few commenters noted concern that that the NQF intends to continue its We look forward to working with adjusting for social risk factors will not work to evaluate the impact of social stakeholders as we consider the issue of address the underlying disparities that risk factor adjustment on intermediate accounting for social risk factors and are associated with poor health outcome and outcome measures for an reducing health disparities in CMS outcomes and could instead lead to additional three years. We understand programs. Of note, implementing any of masking these disparities. One that the extension of this work will the above methods would be taken into commenter noted that using social risk allow NQF to determine further how to consideration in the context of how this factors may not be appropriate until it effectively account for social risk factors and other CMS programs operate (for is clear how the information is collected through risk adjustment and other example, data submission methods, and shared. One commenter strategies in quality measurement. availability of data, statistical recommended that any risk adjustment As we continue to consider the considerations relating to reliability of methodology adopted adhere to CMS’ analyses and recommendations from data calculations, among others), so we previously adopted standards of setting these reports and the results of the NQF also welcome comment on operational minimum case volumes and using trial on risk adjustment for quality considerations. CMS is committed to confidence intervals. Some commenters measures, we are continuing to work ensuring that its beneficiaries have noted that better data sources for with stakeholders in this process. As we access to and receive excellent care, and socioeconomic status are needed, have previously communicated, we are that the quality of care furnished by including patient-level and community- concerned about holding providers to providers and suppliers is assessed level data sources. different standards for the outcomes of fairly in CMS programs. Response: We appreciate all the their patients with social risk factors We received extensive comments in comments and interest in this topic. As because we do not want to mask response to our request for public we have previously stated regarding risk potential disparities or minimize comments on whether we should adjustment of publicly reported data for incentives to improve the outcomes for account for social risk factors in the these factors, we are concerned about disadvantaged populations. Keeping Hospital OQR Program, and if so, what holding providers to different standards this concern in mind, in the proposed method or combination of methods for the outcomes of their patients with rule we sought public comment on would be most appropriate for social risk factors, because we do not whether we should account for social accounting for social risk factors. want to mask potential disparities or Comment: Many commenters risk factors in the Hospital OQR minimize incentives to improve supported CMS’ effort to address social Program, and if so, what method or outcomes for disadvantaged risk factors in the Hospital OQR populations. With respect to public combination of methods would be most Program, noting that social risk factors reporting, while we agree with appropriate for accounting for social are powerful drivers of outcomes and commenters and believe it is important risk factors. Examples of methods requested that CMS adopt risk to avoid a scenario in which underlying include: Confidential reporting to adjustment methodologies soon. disparities are masked rather than providers of measure rates stratified by Commenters also noted that lack of risk addressed, we also agree with social risk factors; public reporting of adjustment can contribute to disparities commenters who support the public stratified measure rates; and potential by diverting resources away from reporting of risk-adjusted data. We risk adjustment of a particular measure communities in need. appreciate the need to balance risk as appropriate based on data and One commenter specifically adjustment as a strategy to account for evidence. recommended risk adjustment in quality social risk factors with the concern that In addition, we requested public measurement in the psychiatric setting. risk adjustment could minimize comment on which social risk factors Another commenter recommended that incentives and reduce efforts to address might be most appropriate for reporting when identifying social risk factors, disparities for patients with social risk stratified measure scores and/or CMS consider the relationship with the factors. We believe that the path forward potential risk adjustment of a particular outcome of interest, a risk factor’s should incentivize improvements in measure. Examples of social risk factors presence at the start of care, and health outcomes for disadvantaged include, but are not limited to, dual whether it can be modified or populations while ensuring that eligibility/low-income subsidy, race and manipulated through providers’ actions. beneficiaries have access to excellent ethnicity, and geographic area of A third commenter noted that care. residence. We requested comments on approaches to risk adjustment should be As with previous policies, we intend which of these factors, including current measure-specific. to follow our previously adopted A few commenters recommended that standards for setting case minimums. 42 NQF. NQF Initiative to Determine the Impact of Adjusting Healthcare Performance Measures for CMS apply risk adjustment by We refer readers to the CY 2009 OPPS/ Social Risk Factors Highlights Successes, stratifying providers into groups by ASC final rule with comment period (73 Opportunities. Available at: https:// proportion of patients that are at risk, FR 68773 through 68775) where we www.qualityforum.org/News_And_Resources/Press_ noting that this approach does not discuss these standards. In addition, we _ _ _ _ _ Releases/2017/NQF Initiative to Determine the acknowledge that administrative claims Impact_of_Adjusting_Healthcare_Performance_ require measure-level research and Measures_for_Social_Risk_Factors_Highlights_ recommending that risk adjustment data can be limited; we will investigate Successes,_Opportunities.aspx. results be shared with providers. One the feasibility and appropriateness of
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additional data sources for obtaining unintended consequences that result 3. Retention of Hospital OQR Program patient and community-level data. from risk adjustment. Measures Adopted in Previous Payment We reiterate that we are committed to Response: We plan to actively Determinations ensuring that CMS beneficiaries have perform additional research and We previously adopted a policy to access to and receive excellent care and monitor for trends to prevent that the quality of care furnished by retain measures from the previous year’s unintended consequences. We intend to Hospital OQR Program measure set for providers and suppliers is assessed conduct further analyses on the impact fairly in CMS programs. We thank the subsequent years’ measure sets in the of different approaches to accounting for commenters, and we will consider their CY 2013 OPPS/ASC final rule with social risk factors in quality programs. views as we develop further policy comment period (77 FR 68471). Quality In addition, we will consider the regarding social risk factors in the measures adopted in a previous year’s commenters’ suggestion that we conduct Hospital OQR Program. rulemaking are retained in the Hospital Comment: Many commenters empirical testing of risk-adjusted quality OQR Program for use in subsequent recommended many factors to consider metrics, and assess the potential impact years unless otherwise specified. We including: Body mass index; race; of the findings from such testing on the refer readers to that rule for more smoking status; age; sex; back pain; pain prioritization of national data collection, information. We did not propose any in non-operative lower extremity joint; in relation to risk adjustment changes to our retention policy for health risk status; mental health factors; methodologies. We look forward to previously adopted measures. chronic narcotic use; socioeconomic continuing to work with stakeholders such as NQF, ASPE, the National 4. Removal of Quality Measures From status; pre-procedure ambulatory status; the Hospital OQR Program Measure Set literacy; marital status; live-in home Academy of Medicine, and AHRQ. support; family support structure; home We thank commenters for their a. Considerations in Removing Quality health resources; patient travel distance; suggestion that we allow collection of Measures From the Hospital OQR homelessness; community distress; sociodemographic data elements in Program unavoidable readmissions; readmission electronic health records, but note that In the FY 2010 IPPS/LTCH PPS final risks; and poverty; as well as access to the Hospital OQR Program does not yet rule (74 FR 43863), for the Hospital IQR health care, transportation, and healthy include eCQMs. Any testing and Program, we finalized a process for food. methodologies used would be made immediate retirement, which we later One commenter recommended that transparent through future rulemaking, termed ‘‘removal,’’ of Hospital IQR the following variables not be used: which includes the public notice and Program measures based on evidence American Society of Anesthesiologists comment process. Moreover, any score; range of motion; or mode of that the continued use of the measure as proposals would be made in future specified raised patient safety concerns. patient-reported outcome measure rulemaking after further analysis, collection. Several commenters We adopted the same immediate research, and continued stakeholder measure retirement policy for the supported the use of dual eligible status engagement. as a factor, while one commenter Hospital OQR Program in the CY 2010 Comment: Several commenters opposed it and noted concern that that OPPS/ASC final rule with comment recommended that CMS align across it does not reflect the conditions where period (74 FR 60634 through 60635). We quality payment programs when the hospital is located and that there are refer readers to the CY 2013 OPPS/ASC variations between States in dual accounting for social risk factors. final rule with comment period (77 FR eligibility status. Response: We thank the commenters 68472 through 68473) for a discussion Response: We appreciate commenters’ for their feedback. We intend to of our reasons for changing the term recommendations regarding specific investigate options for adjusting for ‘‘retirement’’ to ‘‘removal’’ in the social risk factor variables and will social risk factors with continued Hospital OQR Program. We did not consider them as we continue exploring consideration of alignment across propose any changes to our policy to options for accounting for social risk programs. immediately remove measures as a result of patient safety concerns. factors in the Hospital OQR Program. Comment: Several commenters asked Comment: Several commenters that CMS consider the impact of In the CY 2013 OPPS/ASC final rule recommended empirical testing to socioeconomic data collection on the with comment period, we finalized a set prioritize the national collection of data patient as well as on provider burden. of criteria for determining whether to that are most essential for valid risk A few commenters recommended that remove measures from the Hospital adjustment methodologies and that CMS CMS consider potential administrative OQR Program. We refer readers to the focus on factors that have an empirically complexities as CMS develops social CY 2013 OPPS/ASC final rule with proven relationship to outcomes or risk factor adjustment processes. comment period (77 FR 68472 through processes of care metrics. Some 68473) for a discussion of our policy on commenters recommended that CMS Response: As we consider the removal of quality measures from the consider recommendations from NQF, feasibility of collecting patient-level Hospital OQR Program. The benefits of ASPE, the National Academy of data and the impact of strategies to removing a measure from the Hospital Medicine, and the Agency for account for social risk factors through OQR Program will be assessed on a Healthcare Research and Quality further analysis, we will also continue case-by-case basis (79 FR 66941 through (AHRQ). One commenter suggested that to evaluate the reporting burden on 66942). We note that, under this case- CMS engage providers and vendors in providers and patients. by-case approach, a measure will not be demonstration projects allowing We thank all of the commenters for removed solely on the basis of meeting collection of sociodemographic data their input and will consider all any specific criterion. We refer readers elements in electronic health records. A suggestions as we continue to assess the to the CY 2013 OPPS/ASC final rule few commenters recommended that issue of accounting for social risk factors with comment period (77 FR 68472 testing and methodologies be made within individual measures, the through 68473) for our list of factors transparent. Some commenters also Hospital OQR Program as a whole, and considered in removing measures from recommended that CMS monitor any across CMS quality programs. the Hospital OQR Program. We did not
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propose any changes to our measure exactly meet one of the specific measure dimension of the HCAHPS Survey in removal policy. removal criteria finalized for the the Patient- and Caregiver-Centered Hospital OQR Program (77 FR 68472 Experience of Care/Care Coordination b. Criteria for Removal of ‘‘Topped-Out’’ through 68473), it has the potential to domain beginning with the FY 2018 Measures lead to negative unintended program year for the Hospital VBP We refer readers to the CY 2015 consequences (removal factor #7). Program for similar reasons. In addition, OPPS/ASC final rule with comment Therefore, we proposed to remove OP– in the FY 2018 IPPS/LTCH PPS final period where we finalized our proposal 21: Median Time to Pain Management rule (82 FR 38342), we finalized to refine the criteria for determining for Long Bone Fracture for the CY 2020 refinements to the former pain when a measure is ‘‘topped-out’’ (79 FR payment determination and subsequent management questions in the HCAHPS 66942). We did not propose any changes years due to the concerns described in Survey measure for the Hospital IQR to our ‘‘topped-out’’ criteria policy. more detail below. Program. c. Removal of Quality Measures From Given the growing body of evidence We invited public comment on our the Hospital OQR Program Measure Set on the risks of opioid misuse, CMS has proposal to remove the OP–21: Median developed a strategy to impact the Time to Pain Management for Long In the CY 2018 OPPS/ASC proposed national opioid misuse epidemic by Bone Fracture measure for the CY 2020 rule (82 FR 33673), we proposed to combating nonmedical use of payment determination and subsequent remove a total of six measures. prescription opioids, opioid use years as discussed above. Specifically, beginning with the CY disorder, and overdose through the Comment: Many commenters 2020 payment determination, we promotion of safe and appropriate supported the removal of OP–21 for the proposed to remove: (1) OP–21: Median opioid utilization, improved access to CY 2020 payment determination noting Time to Pain Management for Long treatment for opioid use disorders, and concern about the potential incentive to Bone Fracture; and (2) OP–26: Hospital evidence-based practices for acute and over prescribe opioids. One commenter Outpatient Volume Data on Selected chronic pain management.43 applauded CMS’ efforts to combat the Outpatient Surgical Procedures. In Due to the potential for a opioid epidemic. A few commenters addition, beginning with the CY 2021 misinterpretation of the intent of the noted that the measure could be more payment determination, we proposed to measure, we are concerned that OP–21: appropriate or valuable if it were remove: (1) OP–1: Median Time to Median Time to Pain Management for refined, for example to include oral pain Fibrinolysis; (2) OP–4: Aspirin at Long Bone Fracture may create undue medication or to ensure that it does not Arrival; (3) OP–20: Door to Diagnostic pressure for hospital staff to prescribe incentivize prescribing opioids. One Evaluation by a Qualified Medical more opioids. We note that the measure commenter recommended that CMS Professional; and (4) OP–25: Safe only assesses the time to initial, acute remove the measure for the CY 2019 Surgery Checklist. By removing these administration of pain medication in a payment determination. six measures, our intent is to alleviate specific acute clinical situation, and Response: We disagree that it would the maintenance costs and does not promote long-term pain be more appropriate to refine this administrative burden to hospitals medication prescriptions. In fact, this measure. We do not believe that associated with retaining them. While measure assesses an element of introducing a modified version of the we proposed to remove two measures appropriate pain management, measure would address our main beginning with the CY 2020 payment specifically the time to pain medication concern regarding potential for determination and four measures for the administration in the case of long bone misinterpretation of the intent of the CY 2021 payment determination, in this fracture. In addition, the measure measure because whether pain final rule, we are finalizing removal of assesses the use of both opioid and management is initiated, our main all six measures for the CY 2020 nonopioid pain medications. While we concern for misinterpretation, is what payment determination. These are acknowledge that pain control is an this measure is meant to assess. As discussed in detail below. important issue for patients and clinical stated in our proposal, many factors care, and the measure does not call for outside the control of CMS quality (1) Removal of OP–21: Median Time to increased opioid prescriptions, many program requirements may contribute to Pain Management for Long Bone factors outside the control of CMS the perception of a link between the Fracture Beginning With the CY 2020 quality program requirements may measure and opioid prescribing Payment Determination contribute to the perception of a link practices. Although we are not aware of We refer readers to the CY 2011 between the measure and opioid any scientific studies that support an OPPS/ASC final rule with comment prescribing practices. Although we are association between this measure and period (75 FR 72088), where we adopted not aware of any scientific studies that opioid prescribing practices, out of an the OP–21: Median Time to Pain support an association between this abundance of caution, we proposed to Management for Long Bone Fracture measure and opioid prescribing remove the measure in order to remove measure. This process of care measure practices, out of an abundance of any potential ambiguity and to avoid assesses the median time from caution, we proposed to remove the misinterpretation of the intent of the emergency department arrival to time of measure in order to remove any measure. We note that due to initial oral, nasal, or parenteral pain potential ambiguity and to avoid operational limitations, we cannot medication (opioid and non-opioid) misinterpretation of the intent of the remove the measure for the CY 2019 administration for emergency measure. We also note that, in the CY payment determination. The CY 2020 department patients with a principal 2017 OPPS/ASC final rule with payment determination (CY 2018 data diagnosis of long bone fracture (LBF). comment period (81 FR 79856), we collection) is the earliest we can remove We have previously finalized a policy removed the Pain Management this measure from the program. to note that the benefits of removing a Comment: One commenter did not measure from the Hospital OQR 43 CMS Opioid Misuse Strategy 2016. Available support the proposal to remove OP–21 Program will be assessed on a case-by- at: https://www.cms.gov/Outreach-and-Education/ and noted that there is a lack of Outreach/Partnerships/Prescription-Drug- case basis (79 FR 66941 through 66942). Information-for-Partners-Items/CMS-Opioid- evidence that the measure incentivizes Accordingly, although it does not Misuse-Strategy-2016.html. overprescribing of opioids.
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Response: We acknowledge the readers to section XIV.B.3.b.(3) of this elevation myocardial infarction.45 commenter’s concerns. As stated in our final rule with comment period, where Because OP–1: Median Time to proposal, although we are not aware of the ASCQR Program is finalizing the Fibrinolysis measures only the median any scientific studies that support an removal of a similar measure. time from door to needle and does not association between this measure and We invited public comment on our note whether or not that value exceeds opioid prescribing practices, out of an proposal to removal the OP–26: Hospital the clinical best practice of 30 minutes, abundance of caution, however, we Outpatient Volume Data on Selected we do not believe that reporting of OP– believe it is important to remove the Outpatient Surgical Procedures measure 1 improves quality of care or patient measure in order to remove any for the CY 2020 payment determination outcomes. In addition, we believe that potential ambiguity and to avoid any and subsequent years as discussed retaining OP–1: Median Time to misinterpretation of the intent of the above. Fibrinolysis would be redundant with measure. We want to ensure that the Comment: Many commenters OP–2: Fibrinolytic Therapy Received Hospital OQR Program measure set does supported the removal of OP–26 for the Within 30 Minutes of ED Arrival. As a not create any potential undue pressure CY 2020 payment determination. One result, we proposed to remove OP–1: for hospital staff to overprescribe commenter recommended that CMS Median Time to Fibrinolysis for the CY opioids. remove the measure for the CY 2019 2021 payment determination and After consideration of the public payment determination. subsequent years. We note that although comments we received, we are Response: We thank the commenters OP–1: Median Time to Fibrinolysis is a finalizing the proposal to remove OP– for their support and feedback. We note chart-abstracted measure, we do not 21: Median Time to Pain Management that due to operational limitations, we expect removing this measure would for Long Bone Fracture for the CY 2020 cannot remove the measure for the CY reduce burden, as the data collected for payment determination and subsequent 2019 payment determination. The CY this measure is required to calculate years, as proposed. 2020 payment determination (CY 2018 another program measure in the AMI measure set (OP–2: Fibrinolytic Therapy (2) Removal of OP–26: Hospital data collection) is the earliest we can remove this measure from the program. Received Within 30 Minutes of ED Outpatient Volume Data on Selected Arrival) and will, therefore, continue to Outpatient Surgical Procedures After consideration of the public comments we received, we are be collected even if the proposal to Beginning With the CY 2020 Payment remove OP–1: Median Time to Determination finalizing our proposal to remove OP– 26: Hospital Outpatient Volume Data on Fibrinolysis is finalized as proposed. We refer readers to the CY 2012 Selected Outpatient Surgical Procedures We invited public comment on our OPPS/ASC final rule with comment for the CY 2020 payment determination proposal to remove OP–1: Median Time to Fibrinolysis for the CY 2021 payment period (76 FR 74468), where we adopted and subsequent years, as proposed. OP–26: Hospital Outpatient Volume determination and subsequent years as Data on Selected Outpatient Surgical (3) Removal of OP–1: Median Time to discussed above. Procedures beginning with the CY 2014 Fibrinolysis Beginning With the CY Comment: Several commenters payment determination. This measure, 2020 Payment Determination supported the proposal to remove OP– 1: Median Time to Fibrinolysis for the which is submitted via a web-based We refer readers to the CY 2008 CY 2021 payment determination. Some tool, collects surgical procedure volume OPPS/ASC final rule with comment commenters supported the proposal to data on eight categories of procedures period (referred to as ‘‘ED–AMI–2— remove the measure, but recommended frequently performed in the outpatient Median Time to Fibrinolysis’’ in 72 FR that it be removed as soon as possible. hospital setting. 66862 through 66865) where we Many commenters supported the We believe there is a lack of evidence adopted OP–1: Median Time to proposal to remove the measure, but to support this measure’s link to Fibrinolysis beginning with services recommended that it be removed improved clinical quality. The measure furnished in CY 2009. This chart- beginning with the CY 2020 payment requires hospitals to report on the abstracted measure assesses the median determination, one year earlier than volumes of surgical procedures time from ED arrival to administration proposed. performed at the facility.44 This of fibrinolytic therapy in ED patients Response: We thank the commenters information, number of surgical with ST-segment elevation on the ECG for their support and feedback. While procedures, does not offer insight into performed closest to ED arrival and planning for the proposed rule, we did the facilities’ overall performance or prior to transfer. not believe we had the logistical quality improvement in regard to We believe that this measure meets capacity to support successful removal surgical procedures. Accordingly, this the following measure removal of all six measures at once from our measure meets the following measure criterion—the availability of a measure systems. Upon further consideration removal criterion: performance or that is more strongly associated with however, we have determined it is, in improvement on a measure does not desired patient outcomes for the fact, operationally feasible to remove result in better patient outcomes (79 FR particular topic (79 FR 66941). We note OP–1 beginning with the CY 2020 66941). We believe the burden of this that the currently adopted OP–2: payment determination rather than the measure, which is submitted via a web- Fibrinolytic Therapy Received Within based tool, outweighs the value, and, 30 Minutes of ED Arrival (72 FR 66862 45 Antman EM, Hand M, Armstrong PW, Bates ER, therefore, we proposed to remove OP– through 66865) has been designed with Green LA, Halasyamani LK, et al. 2007 focused 26: Hospital Outpatient Volume Data on a threshold that is based on a clinical update of the ACC/AHA 2004 Guidelines for the Selected Outpatient Surgical Procedures standard, allows us to measure this Management of Patients With ST-Elevation for the CY 2020 payment determination Myocardial Infarction: A report of the American topic area, and provides meaningful and College of Cardiology/American Heart Association and subsequent years. We also refer clinically relevant data on the receipt of Task Force on Practice Guidelines (Writing Group fibrinolytic therapy. National guidelines to Review New Evidence and Update the ACC/AHA 44 OP–26 Measure Information Form. Available recommend that fibrinolytic therapy be 2004 Guidelines for the Management of Patients at: http://www.qualitynet.org/dcs/ContentServer?c= With ST-Elevation Myocardial Infarction). Journal Page&pagename=QnetPublic%2FPage%2FSpecs given within 30 minutes of hospital of the American College of Cardiology. 2008; ManualTemplate&cid=1228775748170. arrival in patients with ST-segment 51:210–47.
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CY 2021 payment determination as (4) Removal of OP–4: Aspirin at Arrival indistinguishable performance at the proposed. We believe that removing this Beginning With the CY 2020 Payment 75th and 90th percentiles of national measure one year earlier than proposed Determination facility performance; and (2) when the will reduce hourly and financial burden We refer readers to the CY 2008 measure’s truncated coefficient of on hospital. Therefore, we agree that we OPPS/ASC final rule with comment variation (COV) is less than or equal to should remove the measure as soon as period (72 FR 66862 through 66865) 0.10 (79 FR 66942). Based on our possible. where we adopted OP–4: Aspirin at analysis of Hospital OQR Program measure data, we have determined that After consideration of the public Arrival beginning with services performance on this measure is so high comments we received, we are furnished in CY 2009. This chart- and unvarying that meaningful finalizing our proposal to remove OP–1: abstracted measure assesses the rate of distinctions in improvement cannot be Median Time to Fibrinolysis with patients with chest pain or possible heart attack who received aspirin within made; specifically, our analyses show modification. Instead of beginning with 24 hours of arrival or before transferring that there is statistically the CY 2021 payment determination as from the emergency department. indistinguishable performance at the proposed, we are finalizing the removal We previously finalized two criteria 75th and 90th percentiles of national of this measure for the CY 2020 for determining when a measure is facility performance for this measure. payment determination and subsequent ‘‘topped out’’ under the Hospital OQR These analyses are captured in the table years, one year earlier than proposed. Program: (1) When there is statistically below.
OP–4—ASPIRIN AT ARRIVAL TOPPED OUT ANALYSIS
Number of 75th 90th Truncated Encounters hospitals percentile percentile COV
CY 2014 ...... 1,706 100.00 100.00 0.030 CY 2015 ...... 1,749 100.00 100.00 0.035 CY 2016 ...... 1,803 100.00 100.00 0.042
As displayed in the table above, there consideration, we have determined it is, Technical Expert Panel (TEP), is no distinguishable difference in in fact, operationally feasible to remove comprised of experts representing a hospital performance between the 75th OP–4 beginning with the CY 2020 variety of stakeholders and was and 90th percentiles under the OP–4: payment determination rather than the convened by a CMS contractor. These Aspirin at Arrival measure, and the CY 2021 payment determination as concerns include: (1) Limited evidence truncated coefficient of variation has proposed. We believe that removing this linking the measure to improved patient been below 0.10 since 2014. Therefore, measure one year earlier than proposed outcomes; (2) validity concerns related this measure meets both ‘‘topped out’’ will reduce hourly and financial burden to wait times and the accuracy of door- measure criteria for the ASCQR on hospitals. Therefore, we agree that to-door time stamps; and (3) potential Program. we should remove the measure as soon for skewed measure performance due to Thus, we believe the burden of as possible. disease severity and institution-specific reporting this chart-abstracted measure After consideration of the public confounders. After our own analysis, we is not justified by the value of retaining comments we received, we are agree with the TEP’s analysis and it in the program and we proposed to finalizing our proposal to remove OP–4: believe that this measure meets the remove OP–4: Aspirin at Arrival from Aspirin at Arrival measure with following measure removal criterion: the program for the CY 2021 payment modification. Instead of beginning with Performance or improvement on a determination and subsequent years. the CY 2021 payment determination as measure does not result in better patient We invited public comment on our proposed, we are finalizing the removal outcomes. As a result, we believe the proposal to remove the OP–4: Aspirin at of this measure for the CY 2020 burden of continuing to include this Arrival measure for the CY 2021 payment determination and subsequent chart-abstracted measure in the program payment determination and subsequent years, one year earlier than proposed. outweighs the benefits; and thus, we years as discussed above. proposed to remove OP–20: Door to (5) Removal of OP–20: Door to Comment: Several commenters Diagnostic Evaluation by a Qualified Diagnostic Evaluation by a Qualified supported the removal of OP–4: Aspirin Medical Professional for the CY 2021 Medical Professional Beginning With at Arrival for the CY 2021 payment payment determination and subsequent the CY 2020 Payment Determination determination. Some commenters years. supported the proposal to remove the We refer readers to the CY 2011 We invited public comment on our measure, but recommended that it be OPPS/ASC final rule with comment proposal to remove OP–20: Door to removed as soon as possible. Many period (75 FR 72087 through 72088) Diagnostic Evaluation by a Qualified commenters supported the proposal to where we adopted OP–20: Door to Medical Professional for the CY 2021 remove the measure, but recommended Diagnostic Evaluation by a Qualified payment determination and subsequent that it be removed beginning with the Medical Professional for the CY 2013 years as discussed above. CY 2020 payment determination, one payment determination. This chart- Comment: Several commenters year earlier than proposed. abstracted measure assesses the time supported the proposal to remove OP– Response: We thank the commenters from ED arrival to provider contact for 20: Door to Diagnostic Evaluation by a for their support. While planning for the Emergency Department patients. Qualified Medical Professional for the proposed rule, we did not believe we During regular measure maintenance, CY 2021 payment determination. Some had the logistical capacity to support specific concerns about OP–20: Door to commenters supported the proposal to successful removal of all six measures at Diagnostic Evaluation by a Qualified remove the measure, but recommended once from our systems. Upon further Medical Professional were raised by a that it be removed as soon as possible.
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Many commenters supported the found a potential for skewed measure (6) Removal of OP–25: Safe Surgery proposal to remove the measure, but performance due to disease severity and Checklist Use Beginning With the CY recommended that it be removed institution-specific confounders, we do 2020 Payment Determination beginning with the CY 2020 payment not believe modifying the measure to We refer readers to the CY 2012 determination, one year earlier than account for social risk factors will OPPS/ASC final rule with comment proposed. address our primary concern that the period (76 FR 74464 through 74466), Response: We thank the commenters measure is not adequately tied to better where we adopted OP–25: Safe Surgery for their support. While planning for the patient outcomes. We thank the proposed rule, we did not believe we Checklist Use beginning with the CY commenters for their recommendation, had the logistical capacity to support 2014 payment determination. This however; we will take these comments successful removal of all six measures at structural measure of hospital process once from our systems. Upon further into consideration as we continue to assesses whether a hospital employed a consideration, we have determined it is, review and refine the Hospital OQR safe surgery checklist that covered each in fact, operationally feasible to remove Program measure set. In addition, we of the three critical perioperative OP–20 beginning with the CY 2020 acknowledge the suggestion that OP–20 periods (prior to administering payment determination rather than the be refined to account for community anesthesia, prior to skin incision, and CY 2021 payment determination as factors that influence performance and prior to patient leaving the operating proposed. We believe that removing this note that the TEP found a potential for room) for the entire data collection measure one year earlier than proposed skewed measure performance due to period. Based on our review of reported will reduce hourly and financial burden disease severity and institution-specific data under the measure, this measure on hospitals. Therefore, we agree that confounders. However, modifying the meets our first criterion for measure we should remove the measure as soon measure to account for social risk removal that measure performance is so as possible. factors in this or future rulemaking will high and unvarying that meaningful Comment: A few commenters not address our primary concern that distinctions and improvements in expressed concern that there are the measure is not adequately tied to performance can no longer be made. socioeconomic pressures that can vary patient outcomes. The Hospital OQR Program by community that cause variation in previously finalized two criteria for After consideration of the public performance on this measure. However, determining when a measure is ‘‘topped these commenters also noted the value comments we received, we are out’’: (1) When there is statistically of the measure and recommended that finalizing our proposal to remove OP– indistinguishable performance at the CMS consider a refined version of OP– 20: Door to Diagnostic Evaluation by a 75th and 90th percentiles of national 20 that stratifies by hospital size and Qualified Medical Professional with facility performance; and (2) when the other factors related to measure modification. Instead of beginning with measure’s truncated coefficient of performance. the CY 2021 payment determination as variation is less than or equal to 0.10 (79 Response: We acknowledge the proposed, we are finalizing the removal FR 66942). Our estimations indicate that suggestion that OP–20 be refined to of this measure for the CY 2020 performance on this measure is trending account for community factors that payment determination and subsequent towards topped out status. This analysis influence performance. While the TEP years, one year earlier than proposed. is captured in the table below.
OP–25—SAFE SURGERY CHECKLIST USE PERFORMANCE ANALYSIS
Number of 75th 90th Truncated Encounters hospitals Rate percentile percentile COV
CY 2012 ...... 3,227 0.910 100.000 100.000 0.314 CY 2013 ...... 3,184 0.949 100.000 100.000 0.232 CY 2014 ...... 3,177 0.963 100.000 100.000 0.196 CY 2015 ...... 3,166 0.970 100.000 100.000 0.176
Based on the analysis above, the surgical checklist is widely used and Surgery Checklist Use measure for the national rate of ‘‘Yes’’ response for the that hospitals will continue its use. In CY 2021 payment determination and OP–25 measure is nearly 1.0, or 100 addition, removal of this measure would subsequent years as discussed above. percent, nationwide, and has remained alleviate the administrative burden to Comment: Several commenters at this level for the last two years. In hospitals associated with reporting on supported the proposal to remove OP– addition, the truncated coefficient of this measure. As such, we believe the 25 for the CY 2021 payment variation has decreased such that it is reporting burden of this measure determination. Some commenters trending towards 0.10 and there is no outweigh the benefits of keeping the supported the proposal to remove the distinguishable difference in hospital measure in the Hospital OQR Program. measure, but recommended removal as performance between the 75th and 90th Therefore, we proposed to remove soon as possible. Many commenters percentiles. We have previously stated OP–25: Safe Surgery Checklist Use for supported the proposal to remove the the benefits of removing a measure from the CY 2021 payment determination and measure, but recommended that it be the Hospital OQR Program will be subsequent years. We refer readers to removed beginning with the CY 2020 assessed on a case-by-case basis (79 FR section XIV.B.3.b.(2) of this final rule payment determination, one year earlier 66941 through 66942). We believe that with comment period, where the than proposed. removal of this measure from the ASCQR Program is finalizing a proposal Response: We thank the commenters Hospital OQR Program measure set is to remove a similar measure. for their support. While planning for the appropriate, as there is little room for We invited public comment on our proposed rule, we did not believe we improvement. We believe that safe proposal to remove the OP–25: Safe had the logistical capacity to support
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successful removal of all six measures at 5. Delay of OP–37a–e: Outpatient and enable objective and meaningful once from our systems. Upon further Ambulatory Surgery Consumer comparisons between hospital consideration, we have determined it is, Assessment of Healthcare Providers and outpatient departments. Therefore, we in fact, operationally feasible to remove Systems (OAS CAHPS) Survey-Based proposed to delay implementation of OP–25 beginning with the CY 2020 Measures Beginning With the CY 2020 OP–37a–e beginning with the CY 2020 payment determination rather than the Payment Determination payment determination (2018 data CY 2021 payment determination as We refer readers to the CY 2017 collection) until further action in future proposed. We believe that removing this OPPS/ASC final rule with comment rulemaking. We also refer readers to measure one year earlier than proposed period where we adopted OP–37a–e (81 section XIV.B.4. of this final rule with will reduce hourly and financial burden FR 79771 through 79784), and finalized comment period where we are finalizing on hospitals. Therefore, we agree that data collection and data submission a similar proposal in the ASCQR we should remove the measure as soon timelines (81 FR 79792 through 79794). Program. We invited public comment on our as possible. These measures assess patients’ experience with care following a proposal to delay the OAS CAHPS Comment: A few commenters procedure or surgery in a hospital Survey measures beginning with the CY opposed the proposal to remove OP–25: outpatient department by rating patient 2020 payment determination (2018 data Safe Surgery Checklist Use, noting that experience as a means for empowering collection) as discussed above. the measure adds value. One commenter patients and improving the quality of Comment: Many commenters recommended that CMS retain the their care. supported the proposal to delay measure until there is further evidence In CY 2018 OPPS/ASC proposed rule implementation of the OAS CAHPS that the use of a safe surgery checklist (82 FR 33675), we proposed to delay Survey, noting agreement that an is supporting effective perioperative implementation of the Outpatient and analysis of the national implementation communication. Ambulatory Surgery Consumer will provide valuable information. One Response: As stated in our proposal, Assessment of Healthcare Providers and commenter noted that the high volume of facilities and hospitals participating we believe that there is little room for Systems (OAS CAHPS) Survey-Based Measures OP–37a–e beginning with the in the voluntary national improvement as shown by the data in CY 2020 payment determination (2018 implementation indicates that the data our table above. In addition, removal of data collection) and subsequent years. collection burden of the survey is low. this measure would alleviate the Since our adoption of these measures, Response: We thank the commenters maintenance costs and administrative we have come to believe that we need for their support, and note our belief burden to hospitals of data collection to collect more operational and that an analysis of the national and reporting. While retaining the implementation data. Specifically, we implementation of OAS CAHPS Survey measure may add some nominal value, want to ensure that the survey measures will provide valuable information. we believe that the burdens outweigh appropriately account for patient Comment: Citing the importance of the benefits. In addition, in response to response rates, both aggregate and by patient experience data, a few the suggestion that we retain the survey administration method; reaffirm commenters recommended that CMS measure until there is further evidence the reliability of national move toward mandatory data collection that the use of a safe surgery checklist implementation of OAS CAHPS Survey in the future as some hospitals have is supporting effective perioperative data; and appropriately account for the already invested resources to begin data communication, we would like to make burden associated with administering collection. One commenter clear that high performance on OP–25: the survey in the outpatient setting of recommended a dry run for the first Safe Surgery Checklist Use is not care. We note that commenters quarter of mandatory implementation. A intended to indicate whether expressed concern over the burden few commenters recommended that the perioperative communication among associated with the survey in the CY survey be voluntary for all future years team members is effective; this measure 2017 OPPS/ASC final rule with of the program. Another commenter comment period (81 FR 79777). We is not specified to assess the recommended that the survey be believe that the voluntary national effectiveness of a team’s introduced with advance notice so implementation of the survey, which communication, only whether a safe hospitals can prepare. began in January 2016, would provide Response: We thank the commenters surgery checklist is used. Therefore, we valuable information moving forward.46 do not believe continuing to collect—or, for their recommendations, and will We plan to conduct analyses of the take these comments under conversely, ceasing to collect—data national implementation data to under this measure will assess or affect consideration as we craft future policy undertake any necessary modifications for the OAS CAHPS Survey. First, we the effectiveness of perioperative to the survey tool and/or CMS systems. acknowledge the work completed thus communication within Hospital We believe it is important to allow time far by hospitals beginning to prepare for Outpatient Departments. for any modifications before requiring OAS CAHPS Survey data collection and After consideration of the public the survey under the Hospital OQR thank them for their commitment to comments we received, we are Program. However, we continue to improving patient experience. We note finalizing our proposal to remove OP– believe that these measures address an that changes to this measure would be 25: Safe Surgery Checklist Use with area of care that is not adequately made in notice and comment addressed in our current measure set modification. Instead of beginning with rulemaking so that stakeholders can and will be useful to assess aspects of the CY 2021 payment determination as prepare. Finally, while we do not care where the patient is the best or only proposed, we are finalizing the removal anticipate conducting a dry run for this source of information. Further, we survey at this time, we refer readers to of this measure for the CY 2020 continue to believe these measures will payment determination and subsequent the voluntary national implementation of the OAS CAHPS Survey.47 years, one year earlier than proposed. 46 About the National Implementation and Public Reporting. Available at: https://oascahps.org/ General-Information/National-Implementation. 47 Ibid.
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Comment: Several commenters noted Survey, including services like program including patient reported specific concerns about the OAS CAHPS application of a cast or splint, in order outcomes and patient and family Survey, including that the survey is to ensure that only patients receiving engagement.54 Several MAP workgroup unnecessarily long, that not all of the applicable procedures are surveyed.48 members noted that CMS should questions are relevant, and that We thank the commenters and will take consider how these measures are related requiring a standardized survey all comments under consideration as we to other existing ambulatory surveys to prevents hospitals from targeting craft future policy for the OAS CAHPS ensure that patients and facilities are specific areas for improvement. Some Survey. not overburdened. In addition, we refer commenters noted that the use of a Comment: Several commenters readers to the CY 2017 OPPS/ASC final third-party vendor is too costly. Several recommended that the survey be NQF- rule with comment period (81 FR commenters recommended that vendors endorsed prior to implementation and 79775), where we received public should provide electronic or email that the survey should be refined with comments on this measure during options for conducting the OAS CAHPS input from stakeholders. development. Survey in order to increase response Response: Section 1833(t)(17)(C)(i) of Comment: One commenter requested rates. Others recommended that CMS the Act does not require that each that survey development and testing administer the survey on its Web site. measure we adopt for the Hospital OQR data be made public. One commenter noted concern that Program be endorsed by a national Response: We refer commenters to the timely results are not provided. A few consensus building entity, or the NQF voluntary national implementation of commenters expressed concern about specifically. While we strive to adopt the OAS CAHPS Survey for more the use of CPT codes to determine NQF-endorsed measures when feasible information on results to date (https:// eligibility for the survey and one noted and practicable, we believe the oascahps.org/General-Information/ that the CPT codes include procedures requirement that measures reflect National-Implementation). that a patient may not perceive as a consensus among affected parties can be After consideration of the public surgery. achieved in other ways, including comments we received, we are Response: While Web-based surveys through the measure development finalizing the proposal to delay are not available survey modes at process, stakeholder input via a implementation of the Outpatient and present, we are actively investigating Technical Expert Panel (TEP), review by Ambulatory Surgery Consumer these modes as possible options for the the MAP, broad acceptance and use of Assessment of Healthcare Providers and future. We are exploring whether the measure, and public comments. As Systems (OAS CAHPS) Survey-based hospitals and ASCs receive reliable stated in the CY 2017 OPPS/ASC final Measures (OP–37a–e) beginning with email addresses from patients and rule with comment period (81 FR the CY 2020 payment determination (CY whether there is adequate access to the 79772), the OAS CAHPS Survey 2018 data collection) until further action internet across all types of patients. measures were included on the CY 2014 in future rulemaking, as proposed. We Ultimately, the purpose of the MUC list,49 and reviewed by the MAP.50 refer readers to section XIV.B.4. of this investigation is to ensure that any future The MAP encouraged continued final rule with comment where we are survey administration method does not development of these survey-based also finalizing delay of the OAS CAHPS introduce bias in the survey process and measures; however, we note that these Survey-based measures in the ASCQR reduces length and burden if at all measures had not been fully specified Program. possible. Although we are investigating by the time of submission to the MUC other modes of survey administration, List.51 The MAP stated that these are 6. Previously Adopted Hospital OQR we do not expect that CMS will directly high impact measures that will improve Program Measure Set for the CY 2020 administer the survey; the survey would both quality and efficiency of care and Payment Determination and Subsequent still be administered through vendors. be meaningful to consumers.52 Further, Years Finally, we acknowledge the concern the MAP stated that given that these We refer readers to the CY 2017 about the use of CPT codes, including measures are also under consideration OPPS/ASC final rule with comment those for procedures that patients may for the ASCQR Program, they help to period (81 FR 79784) for the previously not perceive as surgery, and note that promote alignment across care finalized measure set for the Hospital we will consider this issue. We note that settings.53 It also stated that these OQR Program CY 2020 payment many CPT codes have been excluded measures would begin to fill a gap MAP determination and subsequent years. from inclusion in the OAS CAHPS has previously identified for this These measures also are listed below.
PREVIOUSLY FINALIZED HOSPITAL OQR PROGRAM MEASURE SET FOR THE CY 2020 PAYMENT DETERMINATION AND SUBSEQUENT YEARS
NQF No. Measure name
0287 ...... OP–1: Median Time to Fibrinolysis.† 0288 ...... OP–2: Fibrinolytic Therapy Received Within 30 Minutes of ED Arrival. 0290 ...... OP–3: Median Time to Transfer to Another Facility for Acute Coronary Intervention. 0286 ...... OP–4: Aspirin at Arrival.† 0289 ...... OP–5: Median Time to ECG.†
48 OASCAHPS.org. Additional Procedural Codes Quality Forum, Dec. 2014. Available at: https:// www.qualityforum.org/WorkArea/ for Exclusion from the OAS CAHPS Survey. www.qualityforum.org/Setting_Priorities/ linkit.aspx?LinkIdentifier=id&ItemID=78711. Available at: https://oascahps.org/General- Partnership/Measures_Under_Consideration_List_ 51 Ibid. Information/Announcements/EntryId/80/ 2014.aspx. 52 Additional-Procedural-Codes-for-Exclusion-from- Ibid. 50 the-OAS-CAHPS-Survey. National Quality Forum. MAP 2015 Final 53 Ibid. 49 National Quality Forum. List of Measures Recommendations to HHS and CMS. Rep. National 54 Ibid. under Consideration for December 1, 2014. National Quality Forum, Jan. 2015. Available at: http://
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PREVIOUSLY FINALIZED HOSPITAL OQR PROGRAM MEASURE SET FOR THE CY 2020 PAYMENT DETERMINATION AND SUBSEQUENT YEARS—Continued
NQF No. Measure name
0514 ...... OP–8: MRI Lumbar Spine for Low Back Pain. None ...... OP–9: Mammography Follow-up Rates. None ...... OP–10: Abdomen CT—Use of Contrast Material. 0513 ...... OP–11: Thorax CT—Use of Contrast Material. None ...... OP–12: The Ability for Providers with HIT to Receive Laboratory Data Electronically Directly into their ONC-Certified EHR Sys- tem as Discrete Searchable Data. 0669 ...... OP–13: Cardiac Imaging for Preoperative Risk Assessment for Non-Cardiac, Low-Risk Surgery. None ...... OP–14: Simultaneous Use of Brain Computed Tomography (CT) and Sinus Computed Tomography (CT). 0491 ...... OP–17: Tracking Clinical Results between Visits.† 0496 ...... OP–18: Median Time from ED Arrival to ED Departure for Discharged ED Patients. None ...... OP–20: Door to Diagnostic Evaluation by a Qualified Medical Professional. 0662 ...... OP–21: Median Time to Pain Management for Long Bone Fracture. 0499 ...... OP–22: Left Without Being Seen.† 0661 ...... OP–23: Head CT or MRI Scan Results for Acute Ischemic Stroke or Hemorrhagic Stroke who Received Head CT or MRI Scan Interpretation Within 45 minutes of ED Arrival. None ...... OP–25: Safe Surgery Checklist Use. None ...... OP–26: Hospital Outpatient Volume on Selected Outpatient Surgical Procedures.* 0431 ...... OP–27: Influenza Vaccination Coverage among Healthcare Personnel. 0658 ...... OP–29: Appropriate Follow-Up Interval for Normal Colonoscopy in Average Risk Patients.** 0659 ...... OP–30: Colonoscopy Interval for Patients with a History of Adenomatous Polyps—Avoidance of Inappropriate Use.** 1536 ...... OP–31: Cataracts: Improvement in Patient’s Visual Function within 90 Days Following Cataract Surgery.*** 2539 ...... OP–32: Facility 7-Day Risk-Standardized Hospital Visit Rate after Outpatient Colonoscopy. 1822 ...... OP–33: External Beam Radiotherapy for Bone Metastases. None ...... OP–35: Admissions and Emergency Department (ED) Visits for Patients Receiving Outpatient Chemotherapy. 2687 ...... OP–36: Hospital Visits after Hospital Outpatient Surgery. None ...... OP–37a: OAS CAHPS—About Facilities and Staff.**** None ...... OP–37b: OAS CAHPS—Communication About Procedure.**** None ...... OP–37c: OAS CAHPS—Preparation for Discharge and Recovery.**** None ...... OP–37d: OAS CAHPS—Overall Rating of Facility.**** None ...... OP–37e: OAS CAHPS—Recommendation of Facility.**** † We note that NQF endorsement for this measure was removed. * OP–26: Procedure categories and corresponding HCPCS codes are located at: https://www.qualitynet.org/dcs/ContentServer?c=Page& pagename=QnetPublic%2FPage%2FQnetTier3&cid=1196289981244. ** We note that measure name was revised to reflect NQF title. *** Measure voluntarily collected as set forth in section XIII.D.3.b. of the CY 2015 OPPS/ASC final rule with comment period (79 FR 66946 through 66947). **** Measure reporting delayed beginning with CY 2018 reporting and for subsequent years as discussed in section XIII.B.5. of this final rule with comment period.
7. Newly Finalized Hospital OQR Program. However, beginning with the with the CY 2020 payment Program Measure Set for the CY 2020 CY 2020 payment determination, in determination (2018 data collection). Payment Determination and Subsequent section XIII.B.4.c. of this final rule with The table below outlines the Hospital Years comment period, we are finalizing OQR Program measure set we are proposals to remove six measures, and finalizing in this final rule with In the CY 2018 OPPS/ASC proposed in section XIII.B.5. of this final rule with comment period for the CY 2020 rule (82 FR 33676), we did not propose comment period, we are finalizing a payment determination and subsequent any new measures for the Hospital OQR proposal to delay OP–37a–e beginning years.
NEWLY FINALIZED HOSPITAL OQR PROGRAM MEASURE SET FOR THE CY 2020 PAYMENT DETERMINATION AND SUBSEQUENT YEARS
NQF No. Measure name
0288 ...... OP–2: Fibrinolytic Therapy Received Within 30 Minutes of ED Arrival. 0290 ...... OP–3: Median Time to Transfer to Another Facility for Acute Coronary Intervention. 0289 ...... OP–5: Median Time to ECG.† 0514 ...... OP–8: MRI Lumbar Spine for Low Back Pain. None ...... OP–9: Mammography Follow-up Rates. None ...... OP–10: Abdomen CT—Use of Contrast Material. 0513 ...... OP–11: Thorax CT—Use of Contrast Material. None ...... OP–12: The Ability for Providers with HIT to Receive Laboratory Data Electronically Directly into their ONC-Certified EHR Sys- tem as Discrete Searchable Data. 0669 ...... OP–13: Cardiac Imaging for Preoperative Risk Assessment for Non-Cardiac, Low-Risk Surgery. None ...... OP–14: Simultaneous Use of Brain Computed Tomography (CT) and Sinus Computed Tomography (CT). 0491 ...... OP–17: Tracking Clinical Results between Visits.† 0496 ...... OP–18: Median Time from ED Arrival to ED Departure for Discharged ED Patients. 0499 ...... OP–22: Left Without Being Seen.†
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NEWLY FINALIZED HOSPITAL OQR PROGRAM MEASURE SET FOR THE CY 2020 PAYMENT DETERMINATION AND SUBSEQUENT YEARS—Continued
NQF No. Measure name
0661 ...... OP–23: Head CT or MRI Scan Results for Acute Ischemic Stroke or Hemorrhagic Stroke who Received Head CT or MRI Scan Interpretation Within 45 minutes of ED Arrival. 0431 ...... OP–27: Influenza Vaccination Coverage among Healthcare Personnel. 0658 ...... OP–29: Appropriate Follow-Up Interval for Normal Colonoscopy in Average Risk Patients.* 0659 ...... OP–30: Colonoscopy Interval for Patients with a History of Adenomatous Polyps—Avoidance of Inappropriate Use.* 1536 ...... OP–31: Cataracts: Improvement in Patient’s Visual Function within 90 Days Following Cataract Surgery.** 2539 ...... OP–32: Facility 7-Day Risk-Standardized Hospital Visit Rate after Outpatient Colonoscopy. 1822 ...... OP–33: External Beam Radiotherapy for Bone Metastases. None ...... OP–35: Admissions and Emergency Department (ED) Visits for Patients Receiving Outpatient Chemotherapy. 2687 ...... OP–36: Hospital Visits after Hospital Outpatient Surgery. None ...... OP–37a: OAS CAHPS—About Facilities and Staff.*** None ...... OP–37b: OAS CAHPS—Communication About Procedure.*** None ...... OP–37c: OAS CAHPS—Preparation for Discharge and Recovery.*** None ...... OP–37d: OAS CAHPS—Overall Rating of Facility.*** None ...... OP–37e: OAS CAHPS—Recommendation of Facility.*** † We note that NQF endorsement for this measure was removed. Æ OP–26: Procedure categories and corresponding HCPCS codes are located at: https://www.qualitynet.org/dcs/ContentServer?c=Page& pagename=QnetPublic%2FPage%2FQnetTier3&cid=1196289981244. * We note that measure name was revised to reflect NQF title. ** Measure voluntarily collected as set forth in section XIII.D.3.b. of the CY 2015 OPPS/ASC final rule with comment period (79 FR 66946 through 66947). *** Measure reporting delayed beginning with CY 2018 reporting and for subsequent years as discussed in section XIII.B.5. of this final rule with comment period.
8. Hospital OQR Program Measures and invited public comments on possible mortality, effective patient transitions, Topics for Future Consideration measure topics for future consideration diabetes, obesity, guidelines for In the CY 2018 OPPS/ASC proposed in the Hospital OQR Program. We overused procedures, end of life care rule (82 FR 33678), we requested public specifically requested comment on any according to preferences, cost per comment on: (1) Future measure topics; outcome measures that would be useful episode, behavioral health and patient and (2) future development of OP–2: to add to the Hospital OQR Program as experience. Fibrinolytic Therapy Received Within well as any clinical process measures Response: We thank the commenters 30 Minutes of ED Arrival as an that should be eliminated from the for their recommendations and electronic clinical quality measure Hospital OQR Program. suggestions and agree that there are (eCQM). These are discussed in detail Comment: A few commenters additional high priority topic below. recommended that we adopt the eCQM measurement areas that may be version of OP–18: Median Time from ED appropriate for the Hospital OQR a. Future Measure Topics Arrival to ED Departure for Discharged Program. We will consider the suggested We seek to develop a comprehensive ED Patients. topic areas for future rulemaking and set of quality measures to be available Response: We thank the commenters intend to work with stakeholders as we for widespread use for informed for their feedback. We will consider continue to develop the Hospital OQR decision-making and quality these suggestions as we consider Program measure set. improvement in the hospital outpatient including and developing eCQMs for b. Possible Future Adoption of the setting. The current measure set for the future rulemaking. Electronic Version of OP–2: Fibrinolytic Hospital OQR Program includes Comment: Several commenters Therapy Received Within 30 Minutes of measures that assess process of care, suggested measure topics for future Emergency Department Arrival imaging efficiency patterns, care consideration, including measures that transitions, ED throughput efficiency, address Total Knee Arthroplasty (TKA) We have previously stated that Health Information Technology (health and Total Hip Arthroplasty (THA) automated electronic extraction and IT) use, care coordination, and patient procedures and measures that address reporting of clinical quality data, safety. Measures are of various types, recommended vaccines for adults, including measure results calculated including those of process, structure, including pneumococcal immunization automatically by appropriately certified outcome, and efficiency. Through future measures. A few commenters noted health IT, could significantly reduce the rulemaking, we intend to propose new support for outcome measures, and administrative burden on hospitals measures that help us further our goal recommended that CMS engage with under the Hospital OQR Program (81 FR of achieving better health care and stakeholders in identifying priority 79785). In the CY 2017 OPPS/ASC final improved health for Medicare measurement areas. One commenter rule with comment period (81 FR beneficiaries who receive health care in specifically recommended patient 79786), some commenters supported hospital outpatient settings, while reported outcomes and patient reported CMS’ goal to incorporate electronic aligning quality measures across the experience measures. A commenter clinical quality measures (eCQMs) in Medicare program. recommended the inclusion of pain the Hospital OQR Program. We are moving towards the use of experience and management measures. OP–2: Fibrinolytic Therapy Received outcome measures and away from the One commenter recommended the Within 30 Minutes of Emergency use of clinical process measures across following topic areas for quality Department Arrival was finalized in the our Medicare quality reporting and measures: Patient safety outcomes, CY 2008 OPPS/ASC final rule with value-based purchasing programs. We readmission rates, risk-adjusted comment period (72 FR 66865), where
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it was designated as ED–AMI–3. In the Emergency Department Arrival or for the previously adopted measures can CY 2009 OPPS/ASC final rule with propose the eCQM in future rulemaking. be found on the QualityNet Web site at: comment period (73 FR 68761), the Comment: Other commenters opposed https://www.qualitynet.org/dcs/Content measure was re-labeled as OP–2 for the the adoption of eCQMs in the Hospital Server?c=Page&pagename=Qnet CY 2010 payment determination and OQR Program and expressed concern Public%2FPage%2FQnetTier2&cid= subsequent years. OP–2 measures the that eCQMs add, rather than reduce, 1196289981244. number of AMI patients receiving administrative burden. Some For a history of our policies regarding fibrinolytic therapy during the ED visit commenters recommended that CMS maintenance of technical specifications with a time from hospital arrival to delay implementation of eCQMs in the for quality measures, we refer readers to fibrinolysis of 30 minutes or less. Hospital OQR Program until the vendor the CY 2010 OPPS/ASC final rule with We are considering developing OP–2: and CMS systems issues noted in comment period (74 FR 60631), the CY Fibrinolytic Therapy Received Within Hospital IQR Program rulemaking are 2011 OPPS/ASC final rule with 30 Minutes of Emergency Department addressed and until the Hospital IQR comment period (75 FR 72069), and the Arrival 55 as an eCQM and proposing the Program demonstrates accurate and CY 2013 OPPS/ASC final rule with eCQM in future rulemaking. We note feasible submission of electronic data. comment period (77 FR 68469 through that since OP–2 is not yet developed as Response: In the FY 2018 IPPS/LTCH 68470). We did not propose any changes an eCQM; electronic measure PPS final rule (82 FR 38355), to our technical specifications policies. commenters raised concerns about EHR specifications are not available at this 10. Public Display of Quality Measures time. We are considering OP–2: system upgrades, the difficulty of Fibrinolytic Therapy Received Within transitioning to a new EHR vendor, and a. Background 30 Minutes of Emergency Department updating to new editions of certified We refer readers to the CY 2014 and Arrival in particular because we believe health IT. We appreciate commenters CY 2017 OPPS/ASC final rules with this measure is the most feasible out of sharing their concerns about the comment period (78 FR 75092 and 81 all the existing Hospital OQR Program challenges associated with eCQM FR 79791, respectively) for our measures for development as an eCQM. reporting, including the significant previously finalized policies regarding We invited public comment on the expenditure of resources required to public display of quality measures. possible future development and future make necessary changes to health IT In the CY 2018 OPPS/ASC proposed adoption of an eCQM version of OP–2: systems, documentation or utilization of rule (82 FR 33679), we proposed to Fibrinolytic Therapy Received Within EHRs, and workflow process changes update public reporting for the OP–18: 30 Minutes of Emergency Department and acknowledge commenters’ feedback Median Time from ED Arrival to ED Arrival. that many hospitals may not be ready to Departure for Discharged ED Patients Comment: A few commenters report eCQMs. We will take lessons measure. supported the adoption of an eCQM learned from eCQM submission in the b. Public Reporting of OP–18c: Median version of OP–2: Fibrinolytic Therapy Hospital IQR Program into Time From Emergency Department Received Within 30 Minutes of consideration as we develop policy for Arrival to Emergency Department Emergency Department Arrival. Several the Hospital OQR Program. As we stated Departure for Discharged Emergency commenters noted their support for the in the FY 2017 IPPS/LTCH PPS final Department Patients—Psychiatric/ adoption of eCQMs, but expressed rule (81 FR 57177) regarding the Mental Health Patients concern about the future adoption of an Hospital IQR Program, however, we eCQM version OP–2: Fibrinolytic acknowledge that there are initial costs, OP–18 Median Time from ED Arrival Therapy Received Within 30 Minutes of but believe that long-term benefits to ED Departure for Discharged ED Emergency Department Arrival in the associated with electronic data capture Patients was finalized for reporting for Hospital OQR Program noting that other outweigh those costs. In addition, as we the CY 2013 payment determination and stated in the FY 2016 IPPS/LTCH PPS measures, such as OP–18, are already subsequent years in the CY 2011 OPPS/ final rule (80 FR 49696) regarding the specified as an eCQM and that other ASC final rule with comment period (75 Hospital IQR Program, we believe that it measures may be more relevant to the FR 72086). This measure addresses ED is appropriate to consider reporting of Hospital OQR Program since fibrinolytic efficiency in the form of the median eCQMs given that measures available therapy is not always appropriate with time from ED arrival to time of now and those being developed for the the increasing availability of cardiac departure from the ED for patients future are increasingly based on catheterization labs. discharged from the ED (also known as electronic standards. We thank the Response: We will consider OP–18 for ED throughput). Reducing the time commenters for their feedback and future rulemaking. In addition, while patients spend in the ED can improve acknowledge the concerns raised. We we acknowledge that OP–2 may not be the quality of care. As discussed in the will consider these concerns and relevant to all hospitals due to the measure specifications and Measure suggestions as we further consider increased availability of cardiac Information Form (MIF),56 57 OP–18 developing OP–2: Fibrinolytic Therapy catheterization labs, we believe this measure data is stratified into four Received Within 30 Minutes of measure would be important for smaller separate calculations: (1) OP–18a is Emergency Department Arrival as an hospitals that continue to rely on defined as the overall rate; (2) OP–18b eCQM or proposing the eCQM in future fibrinolytic therapy. We thank the is defined as the reporting measure; (3) rulemaking. commenters for their feedback and will OP–18c is defined as assessing consider these concerns and suggestions 9. Maintenance of Technical before we decide whether to develop an Specifications for Quality Measures 56 A Measure Information Form provides detail on eCQM version of OP–2: Fibrinolytic the rationale for a measure as well as the relevant CMS maintains technical numerator statements, denominator statements and Therapy Received Within 30 Minutes of specifications for previously adopted measure calculations. Hospital OQR Program measures. These 57 Hospital OQR Program ED Throughput 55 eCQI Resource Center: https://ecqi.healthit.gov/ Measures Information Form. Available at: http:// eh/ecqms-2016-reporting-period/fibrinolytic- specifications are updated as we modify www.qualitynet.org/dcs/ContentServer?c=Page& therapy-received-within-30-minutes-hospital- the Hospital OQR Program measure set. pagename=QnetPublic%2FPage%2FSpecsManual arrival. The manuals that contain specifications Template&cid=1228775748170.
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Psychiatric/Mental Health Patients; and that hospitals would be able to preview concern that the data could incentivize (4) OP–18d is defined as assessing these data in accordance with our limiting the care provided to these Transfer Patients. previously established 30-day preview patients in the ED in order to discharge Section 1833(t)(17)(E) of the Act, period procedures (81 FR 79791). them quickly. requires that the Secretary establish In developing this proposal, we also Response: We disagree that OP–18c procedures to make data collected under considered proposing to publicly report does not address the Hospital OQR the Hospital OQR Program available to around July 2019 (not 2018 as proposed) Program’s gap in measuring behavioral the public and that such procedures using data from patient encounters health or that it would not provide must ensure that a hospital has the occurring during the first quarter of useful information. We believe this opportunity to review the data that are 2018. However, we decided against this helps to address a gap in measuring to be made public, with respect to the timeline, because under this reporting behavioral health by attempting to hospital prior to such data being made option, we would not be able to publicly address the increased wait times public. Currently, and as detailed in the report behavioral health data until as experienced by mental health patients OP–18 MIF, the OP–18 measure early as July of 2019, creating a delay in in EDs. Research has indicated that publicly reports data only for the our efforts to address the behavioral mental health patients experience a calculations designated as OP–18b: health data gap in the publicly reported prolonged ED length of stay as Median Time from Emergency measure set. compared to other patients, and that Department Arrival to Emergency We invited public comment on our these longer wait times can lead to Department Departure for Discharged proposal to publicly report OP–18c: medication errors and adverse Emergency Department Patients— Median Time from Emergency outcomes.60 Another study Reporting Measure, which excludes Department Arrival to Emergency demonstrated that patients presenting to psychiatric/mental health patients and Department Departure for Discharged the ED with acute myocardial infarction transfer patients.58 Emergency Department Patients— who have a history of depression are The ICD–10 diagnostic codes for OP– Psychiatric/Mental Health Patients given lower priority care.61 In addition, 18c include numerous substance abuse beginning with third quarter 2017 data we believe data from OP–18c will be codes for inclusion in this subset, along as discussed above. useful to researchers and hospital staff with numerous nonsubstance abuse Comment: Some commenters as they attempt to address these codes. We believe it is important to supported the proposal to publicly disparities, as well as to patients publicly report data for OP–18c (Median display OP–18c Median Time from ED choosing a care location. We further Time from Emergency Department Arrival to ED Departure for Discharged disagree that measure sample size will Arrival to Emergency Department ED Patients—Psychiatric/Mental Health lead to inconsistent measure results. Departure for Discharged Emergency Patient, noting that the data can be This measure has undergone the NQF Department Patients—Psychiatric/ valuable to improving patient care. endorsement process and, as such, has Mental Health Patients) to address a Response: We thank the commenters been tested and determined to be behavioral health gap in the publicly for their support; we agree that these reliable.62 Although, we acknowledge reported Hospital OQR Program data can be useful toward improving commenters concerns that substance measure set. Therefore, in the CY 2018 patient care for these patients. abuse patients may spend more time in OPPS/ASC proposed rule (82 FR 33679), Comment: Several commenters the ED, we believe it is important to not we proposed to also publicly report OP– opposed the proposal to publicly report separate substance abuse patients in the 18c and begin public reporting as early OP–18c: Median Time from ED Arrival measure, as research shows that illicit as July of 2018 using data from patient to ED Departure for Discharged ED drug use is particularly high among encounters during the third quarter of Patients—Psychiatric/Mental Health adults with serious mental illnesses and 2017. In addition, we would make Patients. These commenters expressed that these co-occurring disorders tend to corresponding updates to our MIF to concern that publicly reporting the go undetected and untreated, especially reflect these proposals,59 such as: (1) measure will not address the behavioral among the elderly population.63 64 Renaming OP–18b from ‘‘Median Time health gap in the Hospital OQR Given this, we believe it is important to from Emergency Department Arrival to Program. Several commenters expressed include substance abuse populations for Emergency Department Departure for concern that data on time to departure quality improvement. Discharged Emergency Department may not help patients make care However, the comments received Patients—Reporting Measure’’ to ‘‘OP– decisions. One commenter expressed have shed some light on aspects of this 18b: Median Time from Emergency concern that the measure sample size is particular subset of data that may need Department Arrival to Emergency small, leading to large variation in additional consideration prior to posting Department Departure for Discharged month-to-month performance. Another on the consumer-facing Hospital Emergency Department Patients— commenter recommended that data for Excluding Psychiatric/Mental Health substance abuse and non-substance 60 Pearlmutter, Mark D. et al. Analysis of Patients and Transfer Patients;’’ and (2) abuse patients be separated in publicly Emergency Department Length of Stay for Mental Health Patients at Ten Massachusetts Emergency modifying the form to reflect that OP– reported OP–18c data, citing a concern Departments. Annals of Emergency Medicine, 18c would also be publicly reported. that substance abuse patients may spend Volume 70, Issue 2, 193–202.e16. Administrative changes made to the more time in the ED. 61 Atzema CL, Schull MJ, Tu JV. The effect of a MIF would not affect hospital reporting A few commenters cited concerns that charted history of depression on emergency delays in discharging psychiatric department triage and outcomes in patients with requirements or burden. The data acute myocardial infarction. CMAJ 2011;183:663–9. required for public reporting are already patients are caused by a lack of 62 NQF: Median Time from ED Arrival to ED collected and submitted by participating community resources rather than poor Departure for Discharged ED Patients. Available at: outpatient hospital departments and our quality of care. One commenter https://qualityforum.org/qps/0496. proposal to publicly report OP–18c does recommended that publicly displayed 63 SAMHSA. Results from the 2014 National data for OP–18c also include data on Survey on Drug Use and Health: Mental Health not create additional burden. We note Findings. mental health resources in the 64 Robert Drake. ‘‘Dual Diagnosis and Integrated 58 Ibid. community to provide context for the Treatment of Mental Illness and Substance Abuse 59 Ibid. data. Other commenters expressed Disorder.’’
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Compare Web site. We acknowledge of these data exacerbate the concerns 75108 through 75109). In that final rule commenters’ concerns regarding raised by commenters. We continue to with comment period, we codified these unintended consequences, including believe the measure provides value to procedural requirements at 42 CFR that the time to discharge for mental hospital quality improvement efforts 419.46(a). health patients may be influenced, in and to patients. However, out of an 2. Requirements Regarding Participation part, by the availability of community abundance of caution, we intend to Status resources and that the measure could be make data available on perceived as creating pressure on data.medicare.gov instead of Hospital a. Background providers to inappropriately limit care Compare until we have been able to We refer readers to the CY 2014 in order to quickly discharge mental evaluate the concerns raised by OPPS/ASC final rule with comment health patients. Literature has shown commenters. period (78 FR 75108 through 75109) and that the number of inpatient psychiatric To be clear, data for what is referred the CY 2016 OPPS/ASC final rule with beds as decreased from 400,000 in 1970 to as OP–18b Median Time from 65 comment period (80 FR 70519) for to 50,000 in 2006. Emergency Department Arrival to requirements for participation and Therefore, after considering the public Emergency Department Departure for withdrawal from the Hospital OQR comments we received, including these Discharged Emergency Department Program. We also codified these additional factors, we would like to err Patients—Reporting Measure will still procedural requirements at 42 CFR on the side of caution and take continue to be made available on 419.46(a) and 42 CFR 419.46(b). In the additional time for further consideration Hospital Compare as it has in the past. prior to posting this particular subset of CY 2018 OPPS/ASC proposed rule (82 In addition, in accordance with our FR 33679), we proposed changes to the data on Hospital Compare, a consumer- decision to not publish OP–18c data on facing Web site. As background, we NOP submission deadline, as described Hospital Compare, we are also not below. typically allow 30 days for hospitals to finalizing the proposed measure subset preview their data two months prior to name changes or MIF form changes b. Proposed Changes to the NOP public reporting, after which we deliver described in our proposal. We will Submission Deadline final public reporting files for the continue to work toward finding the We finalized in the CY 2014 OPPS/ Hospital Compare Web site (77 FR best means to make this subset of ASC final rule with comment period (78 68483). Simultaneously, in addition to information more easily understandable FR 75108 through 75109) that posting on Hospital Compare, Hospital to the public and consider other OQR Program quality measure data are participation in the Hospital OQR measures to help fill the behavioral Program requires that hospitals must: (1) also typically published on health gap in the future. data.medicare.gov in downloadable data Register on the QualityNet Web site After consideration of the public before beginning to report data; (2) files.66 67 68 While we will not publicly comments we received, we are report OP–18c on Hospital Compare, we identify and register a QualityNet finalizing the proposal, with security administrator; and (3) complete will instead publish it on modification, as discussed in our data.medicare.gov. Affected parties will and submit an online participation form response above, such that we will make available at the QualityNet.org Web site be notified via CMS listservs, CMS OP–18c rates available to the public on email blasts, national provider calls, and if this form has not been previously https://data.medicare.gov in completed, if a hospital has previously QualityNet announcements regarding downloadable files. We will take the release of preview reports followed withdrawn, or if the hospital acquires a additional time to further assess how new CMS Certification Number (CCN). by the posting of data on a Web site best to make this subset of data available other than Hospital Compare (76 FR In addition, in the CY 2014 OPPS/ASC on the Hospital Compare Web site for final rule with comment period (78 FR 74453). consumers. In addition, we are not Based on the public comments we 75108 through 75109) we finalized the finalizing our proposals to: (1) Rename requirement that hospitals must submit received, we intend to make measure OP–18b from ‘‘Median Time from data available in a downloadable data the NOP according to the following Emergency Department Arrival to deadlines: file rather than on Hospital Compare so Emergency Department Departure for • that we may continue to evaluate the If a hospital has a Medicare Discharged Emergency Department acceptance date before January 1 of the concerns raised by commenters Patients—Reporting Measure’’ to ‘‘OP regarding unintended consequences. We year prior to the affected annual 18b: Median Time from Emergency payment update, the hospital must believe this modified approach to our Department Arrival to Emergency original proposal is more appropriate complete and submit to CMS a Department Departure for Discharged completed Hospital OQR Program than publishing on Hospital Compare, Emergency Department Patients— which is more public facing, because we Notice of Participation Form by July 31 Excluding Psychiatric/Mental Health of the calendar year prior to the affected want to avoid any potential Patients and Transfer Patients;’’ and (2) circumstance in which the publication annual payment update. modify the MIF to reflect that OP–18c • If a hospital has a Medicare would also be publicly reported on acceptance date on or after January 1 of 65 Tuttle GA. Report of the Council on Medical Hospital Compare. Service, American Medical Association: Access to the year prior to the affected annual psychiatric beds and impact on emergency C. Administrative Requirements payment update, the hospital must medicine [Internet]. Chicago (IL): AMA; 2008. submit a completed participation form 66 Data.medicare.gov OP Imaging Measures: 1. QualityNet Account and Security no later than 180 days from the date https://data.medicare.gov/Hospital-Compare/ Administrator Outpatient-Imaging-Efficiency-Hospital/wkfw-kthe. identified as its Medicare acceptance 67 Data.medicare.gov OP Procedure Volume: The previously finalized QualityNet date. https://data.medicare.gov/Hospital-Compare/ security administrator requirements, These requirements are also codified Outpatient-Procedures-Volume/xbz4-gvaz. including setting up a QualityNet at 42 CFR 419.46(a). 68 Data.medicare.gov Timely and Effective Care In the CY 2018 OPPS/ASC proposed Measures: https://data.medicare.gov/Hospital- account and the associated timelines, Compare/Timely-and-Effective-Care-Hospital/yv7e- are described in the CY 2014 OPPS/ASC rule (82 FR 33680), beginning with the xc69. final rule with comment period (78 FR CY 2020 payment determination, we
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proposed to: (1) Revise the NOP codified our submission requirements at These policies are also codified at 42 submission deadline described above, 42 CFR 419.46(c). CFR 419.46(c)(3). In the CY 2018 OPPS/ and (2) make corresponding revisions at We refer readers to the CY 2016 ASC proposed rule (82 FR 33680), we 42 CFR 419.46(a). Specifically, we OPPS/ASC final rule with comment proposed to: (1) Align the timeline proposed to change the NOP submission period (80 FR 70519 through 70520), specifying the initial quarter for which deadlines such that hospitals are where we finalized our proposal to shift hospitals must submit data for all required to submit the NOP any time the quarters upon which the Hospital hospitals that did not participate in the prior to registering on the QualityNet OQR Program payment determinations previous year’s Hospital OQR Program, Web site, rather than by the deadlines are based, beginning with the CY 2018 rather than specifying different specified above. For example, under this payment determination. The finalized timelines for hospitals with Medicare proposal, and in accordance with the deadlines for the CY 2020 payment acceptance dates before versus after data submission deadlines described in determination and subsequent years are January 1 of the year prior to an affected section XIII.D.1. of this final rule with illustrated in the tables below. annual payment update; and (2) make comment period, below and finalized in conforming revisions at 42 CFR the CY 2016 OPPS/ASC final rule with CY 2020 PAYMENT DETERMINATION 419.46(c)(3). Specifically, we proposed comment period (80 FR 70519 through AND SUBSEQUENT YEARS that any hospital that did not participate 70520), a hospital submitting data for in the previous year’s Hospital OQR Q1 2019 encounters would be required Clinical Program must submit data beginning to submit the NOP only prior to Patient encounter quarter data with encounters occurring during the submission first calendar quarter of the year prior to registering on the QualityNet Web site, deadline which must be done prior to the data the affected annual payment update. We submission deadline of August 1, 2019 Q2 2018 (April 1–June 30) ...... 11/1/2018 note that hospitals must still follow data (80 FR 70519 through 70520). Q3 2018 (July 1–September submission deadlines corresponding to We believe this proposed timeline is 30) ...... 2/1/2019 the quarter for which they are reporting appropriate, because registration with Q4 2018 (October 1–December data as posted on the QualityNet Web the QualityNet Web site is necessary to 31) ...... 5/1/2019 site. submit data. We believe that extending Q1 2019 (January 1–March 31) 8/1/2019 We invited public comment on our the NOP submission deadline will better proposals to align the initial data For the CY 2020 payment enable hospitals to meet the Hospital submission timeline for all hospitals determination and subsequent years, we OQR Program participation that did not participate in the previous proposed to revise the data submission requirements. year’s Hospital OQR Program and to requirements for hospitals that did not As discussed above, we also proposed make conforming revisions at 42 CFR participate in the previous year’s to make conforming revisions at 42 CFR 419.46(c)(3). Hospital OQR Program. Specifically, we 419.46(a). We did not receive any public We invited public comment on our proposed to revise the first quarter for comment on our proposals. Therefore, proposals as discussed above. which newly participating hospitals are we are finalizing our proposals to align We did not receive any public required to submit data (see details the initial data submission timeline for comment on our proposal to require below). We did not propose any changes all hospitals that did not participate in submission of the NOP any time prior to the previously finalized data the previous year’s Hospital OQR to registering on the QualityNet Web submission deadlines for each quarter. Program and to make conforming In the CY 2013 OPPS/ASC final rule site. However, due to logistical and revisions at 42 CFR 419.46(c)(3), as with comment period (77 FR 68482), we operational constraints, participants in proposed. finalized the following data submission the Hospital OQR Program must still requirements for hospitals that did not 2. Requirements for Chart-Abstracted first login to QualityNet in order to participate in the previous year’s Measures Where Patient-Level Data Are access the NOP form; therefore, we are Hospital OQR Program: Submitted Directly to CMS for the CY unable to implement this proposal. As • If a hospital has a Medicare 2020 Payment Determination and a result, we are not finalizing our acceptance date before January 1 of the Subsequent Years proposals to extend the NOP submission year prior to the affected annual We refer readers to the CY 2013 deadline and to make conforming payment update, the hospital must OPPS/ASC final rule with comment revisions at 42 CFR 419.46(a). We submit data beginning with encounters period (77 FR 68481 through 68484) for intend to revisit this issue in future occurring during the first calendar a discussion of the form, manner, and rulemaking, because we believe that quarter of the year prior to the affected timing for data submission requirements extending the NOP submission deadline annual payment update; of chart-abstracted measures for the CY will better enable hospitals to meet the • If a hospital has a Medicare 2014 payment determination and Hospital OQR Program participation acceptance date on or after January 1 of subsequent years. requirements. the year prior to the affected annual We did not propose any changes to D. Form, Manner, and Timing of Data payment update, the hospital must our policies regarding the submission of Submitted for the Hospital OQR submit data for encounters beginning chart abstracted measure data where Program with the first full quarter following patient-level data are submitted directly submission of the completed Hospital to CMS. 1. Hospital OQR Program Annual OQR Program Notice of Participation We note that, in section XIII.B.4.c. of Payment Determinations Form; and this final rule with comment period, we In the CY 2014 OPPS/ASC final rule • Hospitals with a Medicare are finalizing the removal of OP–21: with comment period (78 FR 75110 acceptance date before or after January Median Time to Pain Management for through 75111) and the CY 2016 OPPS/ 1 of the year prior to an affected annual Long Bone Fracture, OP–1: Median ASC final rule with comment period (80 payment update must follow data Time to Fibrinolysis, OP–4: Aspirin at FR 70519 through 70520), we specified submission deadlines as posted on the Arrival, and OP–20: Door to Diagnostic our data submission deadlines. We also QualityNet Web site. Evaluation by a Qualified Medical
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Professional for the CY 2020 payment 4. Data Submission Requirements for the CY 2014 OPPS/ASC final rule with determination and subsequent years. the OP–37a–e: Outpatient and comment period (78 FR 75097 through Therefore, the following previously Ambulatory Surgery Consumer 75100) for a discussion of the finalized Hospital OQR Program chart- Assessment of Healthcare Providers and requirements for measure data abstracted measures will require Systems (OAS CAHPS) Survey-Based (specifically, the Influenza Vaccination patient-level data to be submitted for the Measures for the CY 2020 Payment Coverage Among Healthcare Personnel CY 2020 payment determination and Determination and Subsequent Years measure (NQF #0431)) submitted via the subsequent years: We refer readers to the CY 2017 Centers for Disease Control and • OP–2: Fibrinolytic Therapy OPPS/ASC final rule with comment Prevention (CDC) NHSN Web site. We Received Within 30 Minutes of ED period (81 FR 79792 through 79794) for did not propose any changes to our Arrival (NQF #0288); a discussion of the previously finalized policies regarding the submission of • OP–3: Median Time to Transfer to requirements related to survey measure data submitted via a Web-based Another Facility for Acute Coronary administration and vendors for the OAS tool. We note that, in section XIII.B.4.c. of Intervention (NQF #0290); CAHPS Survey-based measures. this final rule with comment period, we • However, we refer readers to section OP–5: Median Time to ECG (NQF are finalizing the removal of OP–25: XIII.B.5. of this final rule with comment #0289); Safe Surgery Checklist Use and OP–26: period, where we are finalizing our • OP–18: Median Time from ED Hospital Outpatient Volume on Selected proposal to delay implementation of the Arrival to ED Departure for Discharged Outpatient Surgical Procedures OP–37a–e OAS CAHPS Survey-based ED Patients (NQF #0496); beginning with the CY 2020 payment measures beginning with the CY 2020 • determination and for subsequent years. OP–23: Head CT Scan Results for payment determination (2018 data Therefore, the following web-based Acute Ischemic Stroke or Hemorrhagic collection) until further action in future quality measures previously finalized Stroke Patients who Received Head CT rulemaking. Scan Interpretation Within 45 Minutes As noted in the CY 2017 OPPS/ASC and retained in the Hospital OQR of ED Arrival (NQF #0661). final rule with comment period (81 FR Program will require data to be submitted via a Web-based tool (CMS’ 3. Claims-Based Measure Data 79815), some commenters suggested shortening sections of the survey, such QualityNet Web site or CDC’s NHSN Requirements for the CY 2020 Payment Web site) for the CY 2020 payment Determination and Subsequent Years as the ‘‘About You’’ section. We continue to evaluate the utility of determination and subsequent years: • OP–12: The Ability for Providers We refer readers to the CY 2014 individual questions as we collect new with HIT to Receive Laboratory Data OPPS/ASC final rule with comment data from the survey’s voluntary Electronically Directly into their ONC- period (78 FR 75111 through 75112) for national implementation, and will Certified EHR System as Discrete a discussion of the general claims-based consider different options for shortening Searchable Data (via CMS’ QualityNet measure data submission requirements the OAS CAHPS Survey without the Web site); for the CY 2015 payment determination loss of important data in the future. • and subsequent years. We did not OP–17: Tracking Clinical Results Specifically, we continue to consider between Visits (NQF #0491) (via CMS’ propose any changes to our claims- the removal of two demographic based measures submission policies for QualityNet Web site); questions—the ‘‘gender’’ and ‘‘age’’ • OP–22: Left Without Being Seen the CY 2020 payment determination and questions—from the OAS CAHPS (NQF #0499) (via CMS’ QualityNet Web subsequent years. Survey in a future update. site); There are a total of nine claims-based Comment: Some commenters • OP–27: Influenza Vaccination measures for the CY 2020 payment supported removal of the gender and Coverage among Healthcare Personnel determination and subsequent years: age questions from the survey. (via the CDC NHSN Web site) (NQF • OP–8: MRI Lumbar Spine for Low Response: We thank the commenters #0431); Back Pain (NQF #0514); for their support. We will take these • OP–29: Appropriate Follow-up comments under consideration as we • OP–9: Mammography Follow-Up Interval for Normal Colonoscopy in craft future policies for the OAS CAHPS Rates; Average Risk Patients (NQF #0658) (via Survey. • OP–10: Abdomen CT—Use of CMS’ QualityNet Web site); • OP–30: Colonoscopy Interval for Contrast Material; 5. Data Submission Requirements for Patients with a History of Adenomatous • OP–11: Thorax CT—Use of Contrast Previously Finalized Measures for Data Submitted via a Web-Based Tool for the Polyps—Avoidance of Inappropriate Material (NQF #0513); Use (NQF #0659) (via CMS’ QualityNet • CY 2020 Payment Determination and OP–13: Cardiac Imaging for Subsequent Years Web site); Preoperative Risk Assessment for Non- • OP–31: Cataracts: Improvement in Cardiac, Low Risk Surgery (NQF #0669); We refer readers to the CY 2014 Patient’s Visual Function within 90 • OP–14: Simultaneous Use of Brain OPPS/ASC final rule with comment Days Following Cataract Surgery (NQF Computed Tomography (CT) and Sinus period (78 FR 75112 through 75115) and #1536) (via CMS’ QualityNet Web site); Computed Tomography (CT); the CY 2016 OPPS/ASC final rule with and comment period (80 FR 70521) and the • • OP–32: Facility 7-Day Risk- OP–33: External Beam CMS QualityNet Web site (https://www. Radiotherapy (EBRT) for Bone Standardized Hospital Visit Rate after qualitynet.org/dcs/ContentServer?c= Outpatient Colonoscopy (NQF #2539); Metastases (NQF #1822) (via CMS’ Page&pagename=QnetPublic%2FPage QualityNet Web site). • OP–35: Admissions and Emergency %2FQnetTier2&cid=1205442125082) Department Visits for Patients Receiving for a discussion of the requirements for 6. Population and Sampling Data Outpatient Chemotherapy; and measure data submitted via the CMS Requirements for the CY 2020 Payment • OP–36: Hospital Visits after QualityNet Web site for the CY 2017 Determination and Subsequent Years Hospital Outpatient Surgery (NQF payment determination and subsequent We refer readers to the CY 2011 #2687). years. In addition, we refer readers to OPPS/ASC final rule with comment
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period (75 FR 72100 through 72103) and a value outside of this range at 1 in We invited public comment on our the CY 2012 OPPS/ASC final rule with 1,744,278. proposal to codify our validation comment period (76 FR 74482 through We note that the criteria for targeting targeting criteria as discussed above. 74483) for discussions of our population 50 outlier hospitals, described above, We did not receive any public and sampling requirements. does not specify whether high or low comments on this proposal. Therefore, We did not propose any changes to performing hospitals will be targeted. we are finalizing our proposal to codify our population and sampling Therefore, we clarified that hospitals the previously finalized procedures for requirements. with outlier values indicating targeting hospitals and well as the 7. Hospital OQR Program Validation specifically poor scores on a measure procedures regarding outlier hospitals Requirements for Chart-Abstracted (for example, a long median time to as discussed and clarified above at 42 Measure Data Submitted Directly to fibrinolysis) will be targeted for CFR 419.46(e)(3), as proposed. CMS for the CY 2020 Payment validation. In other words, an ‘‘outlier c. Formalization and Modifications to Determination and Subsequent Years value’’ is a measure value that is greater the Educational Review Process for than 5 standard deviations from the Chart-Abstracted Measures Validation We refer readers to the CY 2013 mean of the measure values for other OPPS/ASC final rule with comment hospitals, and indicates a poor score. (1) Background period (77 FR 68484 through 68487) and Comment: One commenter We have described our processes for the CY 2015 OPPS/ASC final rule with recommended that CMS target hospitals educational review on the QualityNet comment period (79 FR 66964 through for validation whether their score is Web site.69 We note that historically this 66965) for a discussion of finalized greater than five standard deviations process functioned as an outreach and policies regarding our validation above or below the mean, noting that education opportunity we provided to requirements. We also refer readers to very good scores may especially hospitals, but based on our experience, the CY 2013 OPPS/ASC final rule with indicate a need for validation. stakeholder feedback, and more robust comment period (77 FR 68486 through validation requirements, we believed 68487) for a discussion of finalized Response: The intent of this policy is that it would be beneficial to hospitals policies regarding our medical record to target and prevent extreme negative to propose formalizing and updating validation procedure requirements. We values rather than to identify high this process. codified these policies at 42 CFR performance. This is also evidenced in Under the current informal process, if 419.46(e). For the CY 2018 payment the first of our two criteria for targeting results of an educational review indicate determination and subsequent years, hospitals for validation—to target that CDAC or CMS has incorrectly validation is based on four quarters of hospitals that fail the validation scored a hospital after validation, those data (validation quarter 1 (January 1– requirement that applies to the previous results are not changed, but are taken March 31), validation quarter 2 (April year’s payment determination. We into consideration if the hospital 1–June 30), validation quarter 3 (July 1– believe it is appropriate to specifically submits a reconsideration request. September 30), and validation quarter 4 target hospitals with poor performance, Stakeholder feedback, provided via (October 1–December 31)) (80 FR rather than those performing well to email, has indicated that while the 70524). encourage improved performance In the CY 2018 OPPS/ASC proposed among low performing hospitals. We educational review process is helpful to rule (82 FR 33682), we: (1) Clarified the note that only 50 hospitals will be participating hospitals, it is limited in hospital selection process previously selected for validation through these its impact, given that a hospital’s finalized for validation; (2) proposed to targeting criteria and in order to address validation result is not corrected even codify the procedures for targeting the issue of very low performance, we after an educational review determines hospitals at 42 CFR 419.46(e); and (3) believe it is appropriate to use these that CMS reached an incorrect proposed to formalize and update our targeting criteria to identify extreme conclusion regarding a hospital’s educational review process. These are negative measure values. An additional validation score for a given quarter. discussed in more detail below. 450 hospitals will be selected at Based on this feedback, we proposed to random, and will include both low and formalize and update the Hospital OQR a. Clarification high performing hospitals. However, we Program’s chart-abstracted measure In the CY 2012 OPPS/ASC final rule thank the commenter for their feedback validation educational review process. with comment period (76 FR 74485), we that extremely high performance could Our goal is to reduce the number of finalized a validation selection process indicate a need for validation, and will reconsideration requests by identifying in which we select a random sample of take this into consideration as we craft and correcting errors before the final 450 hospitals for validation purposes, future policies. yearly validation score is derived. By identifying and correcting any mistakes and select an additional 50 hospitals b. Codification based on the following specific criteria: early on, this process could help • Hospital fails the validation We note that the previously finalized decrease the burden during the annual requirement that applies to the previous procedures for targeting hospitals for reconsideration process, both for year’s payment determination; or validation, described in section hospitals and CMS. • Hospital has an outlier value for a XIII.D.7.a. of this final rule with Therefore, in an effort to streamline measure based on the data it submits. comment period, and finalized in the this process, we proposed to: (1) We defined an ‘‘outlier value’’ for CY 2012 OPPS/ASC final rule with Formalize this process; and (2) specify purposes of this targeting as a measure comment period (76 FR 74485), are not that if the results of an educational value that appears to deviate markedly yet codified at 42 CFR 419.46. We review indicate that we incorrectly from the measure values for other proposed to codify the previously scored a hospital’s medical records hospitals. Specifically, we would select finalized procedures for targeting hospitals for validation if their measure hospitals and well as the procedures 69 Data Validation—Educational Reviews: regarding outlier hospitals as discussed Hospitals-Outpatient. Available at: http://www. value for a measure is greater than 5 qualitynet.org/dcs/ContentServer?c=Page& standard deviations from the mean, and clarified above at 42 CFR pagename=QnetPublic/Page/QnetTier3&cid= placing the expected occurrence of such 419.46(e)(3). 1228764927987.
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selected for validation, the corrected 2020 payment determination and final rule with comment period (81 FR quarterly validation score would be subsequent years as described above. 79795). used to compute the hospital’s final We did not receive any public For the CY 2020 payment validation score at the end of the comments on our proposal. Therefore, determination and subsequent years, we calendar year. These proposals are we are finalizing the proposal to further proposed that if an educational discussed in more detail below. formalize the chart-abstracted measures review requested for any of the first 3 validation educational review process quarters of validation yields incorrect (2) Educational Review Process for the for the CY 2020 payment determination CMS validation results for chart- CY 2020 Payment Determination and and subsequent years, as proposed. abstracted measures, according to the Subsequent Years review process described above, we (b) Validation Score Review and (a) Formalizing the Educational Review would use the corrected quarterly score, Correction Process as recalculated during the educational As stated above, our informal We previously finalized, in the CY review process, to compute the final CI 76 processes for educational review have 2011 OPPS/ASC final rule with at the end of the calendar year. We been described on the QualityNet Web comment period (75 FR 72105 to note that for the last quarter of site.70 Under the informal process, 72106), that we calculate validation validation, because of the need to hospitals that were selected and scores under the Hospital OQR Program calculate the confidence interval in a received a score for validation may using the upper bound of a one-tailed timely manner and the insufficient time request an educational review in order confidence interval (CI) with a 75 available to conduct educational to better understand the results. Many percent threshold level with a binomial reviews prior to the annual payment times, hospitals request an educational approach. Using that approach, at the update, the validation score review and review to examine any data element end of each calendar year, CMS correction would not be available. discrepancies, if they believe the score computes a CI using the results of all Instead, the existing reconsideration four quarters to determine the final process would be used to dispute any is incorrect, or when they have general 74 questions about their score. Currently, validation score. If the upper bound of unsatisfactory validation result. We hospitals receive validation results on a this confidence interval is 75 percent or refer readers to section XIII.D.9. of this quarterly basis 71 and can request higher, the hospital will pass the final rule with comment period for a Hospital OQR Program validation discussion about our reconsideration informal educational reviews for each 75 quarter. Under this informal process, a requirement. We proposed that if the and appeals process. hospital has 30 calendar days from the results of a validation educational The corrected scores would be date the validation results are posted on review determine that the original applicable to the corresponding quarter, the QualityNet Secure Portal Web site to quarterly validation score was incorrect, for the first 3 quarters of validation, for contact the CMS designated contractor, the corrected score would be used to which a request was submitted. Under currently known as the Validation compute the final validation score and this proposal, after evaluating the Support Contractor (VSC), to request an CI at the end of each calendar year. validation score during the educational educational review.72 In response to a To determine whether a quarterly review process, if results show that request, the VSC obtains and reviews validation score was correct, in the CY there was indeed an error in the medical records directly from the 2018 OPPS/ASC proposed rule (82 FR originally calculated score, we would Clinical Data Abstraction Center (CDAC) 33683), we proposed to use a similar take steps to correct it. However, so as and provides feedback. CMS, or its process as one previously finalized for not to dissuade participation in the contractor, generally provides reconsideration requests. Specifically, educational review process, corrected educational review results and we proposed that during an educational scores identified through the responses via a secure file transfer to the review request, evaluating a validation educational review would only be used hospital.73 score would consist of and be limited to to recalculate the CI if they indicate that We proposed to formalize this reviewing data elements that were the hospital performed more favorably educational review process, as labeled as mismatched (between the than previously determined. If the described above, for the CY 2020 originally calculated measure score and hospital performed less favorably, their payment determination and subsequent the measure score calculated in score would not be updated to reflect years—in other words, starting for validation) in the original validation the less favorable score. validations of CY 2018 data affecting the results. We would also take into We note that under this proposal, the CY 2020 payment determination and consideration written justifications quarterly validation reports issued to subsequent years. provided by hospitals in the hospitals would not be updated to We invited public comment on our Educational Review request. For more reflect the corrected score due to the proposal to formalize the chart- information about the previously burden associated with reissuing abstracted measures validation finalized reconsideration request corrected reports. However, the educational review process for the CY procedures, we refer readers to the CY corrected score would be communicated 2013 OPPS/ASC final rule with to the hospital via secure file format as discussed above. 70 Ibid. comment period (77 FR 68487 through 71 QualityNet: Data Validation—Overview. 68489), the CY 2014 OPPS/ASC final We invited public comment on our Available at: https://www.qualitynet.org/dcs/ rule with comment period (78 FR 75118 proposal, as discussed above for the CY ContentServer?c=Page&pagename=QnetPublic%2F through 75119), the CY 2016 OPPS/ASC 2020 payment determination and Page%2FQnetTier2&cid=1228758729356. final rule with comment period (80 FR subsequent years, to use corrected 72 The educational review request form can be quarterly scores, as recalculated during found at: https://www.qualitynet.org/dcs/Content 70524), and the CY 2017 OPPS/ASC Server?c=Page&pagename=QnetPublic%2FPage the educational review process %2FQnetTier3&cid=1228764927987. 74 QualityNet Data Validation Overview. 73 Hospital OQR Validation Educational Review Available at: https://www.qualitynet.org/dcs/ 76 Validation pass-fail status is determined by the Process: Available at: https://www.qualitynet.org/ ContentServer?c=Page&pagename=QnetPublic%2F confidence interval report. Detail at: http://www. dcs/ContentServer?c=Page&pagename=QnetPublic Page%2FQnetTier2&cid=1228758729356. qualityreportingcenter.com/wp-content/uploads/ %2FPage%2FQnetTier3&cid=1228764927987. 75 Ibid. 2017/01/OQR-CY18-Validation-Webinar.508.2.pdf.
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described and finalized in section extension or exception process under these five areas, as appropriate, can XIII.D.7.c.(2)(a) of this final rule with the Hospital OQR Program. improve administrative efficiencies for comment period above, to compute the In the CY 2017 OPPS/ASC final rule affected facilities or hospitals. final confidence interval for the first 3 with comment period (81 FR 79795), we We note that, in the FY 2018 IPPS/ quarters of validation. finalized an update to our extraordinary LTCH PPS final rule, we examined our Comment: Several commenters circumstances exemption (ECE) policy policies in these areas for the Hospital supported the proposed changes to use to extend the ECE request deadline for Readmissions Reduction Program, the the educational review process to both chart-abstracted and web-based HAC Reduction Program, the Hospital correct validation scores, noting that the measures from 45 days following an IQR Program, the PCHQR Program and policy will increase efficiency and help event causing hardship to 90 days the IPFQR Program (82 FR 38240, hospitals understand their annual following an event causing hardship, 38277, 38410, 38425 and 38473 through validation score. One commenter effective with ECEs requested on or after 38474, respectively) and finalized recommended that CMS accept January 1, 2017. proposals to address differences in these educational review requests from We note that many of our quality areas for those programs. In section facilities that have a passing validation reporting and value-based purchasing XIV.D.6. of this final rule with comment score, given that there could be errors programs share a common process for period, we are also finalizing revisions that result in a mistakenly low, though requesting an exception from program to our ECE policies for the ASCQR still passing, score. reporting due to an extraordinary Program. Response: We thank the commenters circumstance not within a provider’s With the exception of the for their support and note that under the control. The Hospital IQR, Hospital specification of a timeline for us to formalized process we are finalizing, OQR, IPFQR, ASCQR, and PCHQR provide our formal response and the hospitals may request an educational Programs, as well as the Hospital terminology used to describe these review to examine any data element Acquired Condition Reduction Program processes (items 3 and 5 above), the discrepancies, if they believe the score and the Hospital Readmissions Hospital OQR Program is aligned with is incorrect, or when they have general Reduction Program, share similar the existing and proposed policies for questions about their score (82 FR processes for ECE requests. We refer the other quality reporting programs 33682). Under this process, hospitals readers to policies for the Hospital IQR discussed above. As a result, we receive validation results on a quarterly Program (76 FR 51651 through 51652, proposed to rename the process as the basis and can request informal 78 FR 50836 through 50837, 79 FR extraordinary circumstances exceptions educational reviews for each quarter. A 50277, 81 FR 57181 through 57182, and (ECE) policy and make conforming hospital has 30 calendar days from the 42 CFR 412.140(c)(2)), the IPFQR changes to 42 CFR 419.46(d). date the validation results are posted on Program (77 FR 53659 through 53660 a. ECE Policy Nomenclature the QualityNet Secure Portal Web site to and 79 FR 45978), the ASCQR Program contact the CMS designated contractor, (77 FR 53642 through 53643 and 78 FR We have observed that while all currently known as the Validation 75140 through 75141), the PCHQR quality programs listed above have Support Contractor (VSC), to request an Program (78 FR 50848), the HAC developed similar policies to provide educational review. To be clear, Reduction Program (80 FR 49579 exceptions from program requirements educational review requests are not through 49581), and the Hospital to facilities that have experienced limited to hospitals that fail validation; Readmissions Reduction Program (80 extraordinary circumstances, such as any hospital that receives validation FR 49542 through 49543) for program natural disasters, these programs refer to results (pass or fail) may request a specific information about extraordinary these policies using inconsistent validation educational review. circumstances exceptions requests. As terminology. Some programs refer to After consideration of the public noted below, some of these policies these policies as ‘‘extraordinary comments received, we are finalizing were updated in the FY 2018 IPPS/ circumstances extensions/exemptions’’ our proposal to use corrected quarterly LTCH PPS final rule. while others refer to the set of policies scores, as recalculated during the In reviewing the policies for these as ‘‘extraordinary circumstances educational review process described in programs, we recognized that there are exceptions.’’ Several programs section XIII.D.7.c.(2)(a) of this final rule five areas in which these programs have (specifically, the Hospital VBP Program, with comment period above, to compute variances regarding ECE requests. These HAC Reduction Program, and the the final confidence interval for the first are: (1) Allowing the facilities or Hospital Readmissions Reduction 3 quarters of validation for the CY 2020 hospitals to submit a form signed by the Program) are not able to grant payment determination and subsequent facility’s or hospital’s CEO versus CEO extensions to required data reporting years, as proposed. or designated personnel; (2) requiring timelines due to their reliance on data the form be submitted within 30 days external to their program and, thus, the 8. Extraordinary Circumstances following the date that the extraordinary term, ‘‘extraordinary circumstances Exception Process for the CY 2020 circumstance occurred versus within 90 extensions/exemptions’’ is not Payment Determination and Subsequent days following the date the applicable to all programs. However, all Years extraordinary circumstance occurred; of the described programs are able to We refer readers to the CY 2013 (3) inconsistency regarding specification offer exceptions from their reporting OPPS/ASC final rule with comment of a timeline for us to provide our requirements. period (77 FR 68489), the CY 2014 formal response notifying the facility or As stated above, in order to align this OPPS/ASC final rule with comment hospital of our decision; (4) policy across CMS quality programs, we period (78 FR 75119 through 75120), the inconsistency regarding specification of proposed to: (1) Change the name of this CY 2015 OPPS/ASC final rule with our authority to grant ECEs due to CMS policy from ‘‘extraordinary comment period (79 FR 66966), the CY data system issues; and (5) referring to circumstances extensions or 2016 OPPS/ASC final rule with the program as ‘‘extraordinary exemptions’’ to ‘‘extraordinary comment period (80 FR 70524), and 42 extensions/exemptions’’ versus as circumstances exceptions’’ for the CFR 419.46(d) for a complete discussion ‘‘extraordinary circumstances Hospital OQR Program, beginning of our extraordinary circumstances exceptions.’’ We believe addressing January 1, 2018; and (2) revise 42 CFR
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419.46(d) of our regulations to reflect E. Payment Reduction for Hospitals unadjusted payment rates for hospitals this change. We note that changing the That Fail To Meet the Hospital OQR that fail to meet Hospital OQR Program terminology for this policy does not Program Requirements for the CY 2018 requirements, with the exception of change the availability for a hospital to Payment Determination services assigned to New Technology APCs with assigned status indicator ‘‘S’’ request an extension under the Hospital 1. Background OQR Program. or ‘‘‘T’’. We refer readers to the CY 2009 Section 1833(t)(17) of the Act, which OPPS/ASC final rule with comment We invited public comment on these applies to subsection (d) hospitals (as period (73 FR 68770 through 68771) for proposals as discussed above. defined under section 1886(d)(1)(B) of a discussion of this policy. Comment: One commenter supported the Act), states that hospitals that fail to The OPD fee schedule increase factor the proposed alignment of the ECE report data required to be submitted on is an input into the OPPS conversion process across quality reporting measures selected by the Secretary, in factor, which is used to calculate OPPS programs. the form and manner, and at a time, payment rates. To reduce the OPD fee specified by the Secretary will incur a schedule increase factor for hospitals Response: We appreciate the 2.0 percentage point reduction to their that fail to meet reporting requirements, commenter’s support. Outpatient Department (OPD) fee we calculate two conversion factors—a After consideration of the public schedule increase factor; that is, the full market basket conversion factor comment we received, we are finalizing annual payment update factor. Section (that is, the full conversion factor), and the proposal to rename the process as 1833(t)(17)(A)(ii) of the Act specifies a reduced market basket conversion the extraordinary circumstances that any reduction applies only to the factor (that is, the reduced conversion exceptions (ECE) policy and make payment year involved and will not be factor). We then calculate a reduction conforming changes to 42 CFR taken into account in computing the ratio by dividing the reduced 419.46(d), as proposed. applicable OPD fee schedule increase conversion factor by the full conversion factor for a subsequent year. factor. We refer to this reduction ratio as b. Timeline for CMS Response to ECE The application of a reduced OPD fee the ‘‘reporting ratio’’ to indicate that it Requests schedule increase factor results in applies to payment for hospitals that fail reduced national unadjusted payment to meet their reporting requirements. We also note that we believe it is rates that apply to certain outpatient Applying this reporting ratio to the important for facilities to receive timely items and services provided by OPPS payment amounts results in feedback regarding the status of ECE hospitals that are required to report reduced national unadjusted payment requests. We strive to complete our outpatient quality data in order to rates that are mathematically equivalent review of each ECE request as quickly receive the full payment update factor to the reduced national unadjusted as possible. However, we recognize that and that fail to meet the Hospital OQR payment rates that would result if we the number of requests we receive, and Program requirements. Hospitals that multiplied the scaled OPPS relative the complexity of the information meet the reporting requirements receive payment weights by the reduced provided impacts the actual timeframe the full OPPS payment update without conversion factor. For example, to to make ECE determinations. To the reduction. For a more detailed determine the reduced national improve transparency of our process, we discussion of how this payment unadjusted payment rates that applied believe it is appropriate to specify that reduction was initially implemented, to hospitals that failed to meet their we will strive to complete our review of we refer readers to the CY 2009 OPPS/ quality reporting requirements for the each request within 90 days of receipt. ASC final rule with comment period (73 CY 2010 OPPS, we multiplied the final FR 68769 through 68772). full national unadjusted payment rate 9. Hospital OQR Program The national unadjusted payment found in Addendum B of the CY 2010 Reconsideration and Appeals rates for many services paid under the OPPS/ASC final rule with comment Procedures for the CY 2020 Payment OPPS equal the product of the OPPS period by the CY 2010 OPPS final Determination and Subsequent Years conversion factor and the scaled relative reporting ratio of 0.980 (74 FR 60642). payment weight for the APC to which In the CY 2009 OPPS/ASC final rule We refer readers to the CY 2013 the service is assigned. The OPPS with comment period (73 FR 68771 OPPS/ASC final rule with comment conversion factor, which is updated through 68772), we established a policy period (77 FR 68487 through 68489), the annually by the OPD fee schedule that the Medicare beneficiary’s CY 2014 OPPS/ASC final rule with increase factor, is used to calculate the minimum unadjusted copayment and comment period (78 FR 75118 through OPPS payment rate for services with the national unadjusted copayment for a 75119), the CY 2016 OPPS/ASC final following status indicators (listed in service to which a reduced national rule with comment period (80 FR Addendum B to the final rule, which is unadjusted payment rate applies would 70524), and the CY 2017 OPPS/ASC available via the Internet on the CMS each equal the product of the reporting final rule with comment period (81 FR Web site): ‘‘J1’’, ‘‘J2’’, ‘‘P’’, ‘‘Q1’’, ‘‘Q2’’, ratio and the national unadjusted 79795) for a discussion of our ‘‘Q3’’, ‘‘R’’, ‘‘S’’, ‘‘T’’, ‘‘V’’, or ‘‘U’’. In the copayment or the minimum unadjusted reconsideration and appeals procedures. CY 2017 OPPS/ASC final rule with copayment, as applicable, for the We codified the process by which comment period (81 FR 79796), we service. Under this policy, we apply the clarified that the reporting ratio does not participating hospitals may submit reporting ratio to both the minimum apply to codes with status indicator unadjusted copayment and national requests for reconsideration at 42 CFR ‘‘Q4’’ because services and procedures unadjusted copayment for services 419.46(f). We also codified language at coded with status indicator ‘‘Q4’’ are provided by hospitals that receive the § 419.46(f)(3) regarding appeals with the either packaged or paid through the payment reduction for failure to meet Provider Reimbursement Review Board. Clinical Laboratory Fee Schedule and the Hospital OQR Program reporting We did not propose any changes to are never paid separately through the requirements. This application of the our reconsideration and appeals OPPS. Payment for all services assigned reporting ratio to the national procedure. to these status indicators will be subject unadjusted and minimum unadjusted to the reduction of the national copayments is calculated according to
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§ 419.41 of our regulations, prior to any APCs to which we have proposed status To measure the quality of ASC services, adjustment for a hospital’s failure to indicator assignment of ‘‘S’’ and ‘‘T’’). we implemented the ASCQR Program. meet the quality reporting standards We proposed to continue to exclude We refer readers to section XV.A.3. of according to § 419.43(h). Beneficiaries services paid under New Technology the CY 2014 OPPS/ASC final rule with and secondary payers thereby share in APCs. We proposed to continue to apply comment period (78 FR 75122), section the reduction of payments to these the reporting ratio to the national XIV. of the CY 2015 OPPS/ASC final hospitals. unadjusted payment rates and the rule with comment period (79 FR 66966 In the CY 2009 OPPS/ASC final rule minimum unadjusted and national through 66987), section XIV. of the CY with comment period (73 FR 68772), we unadjusted copayment rates of all 2016 OPPS/ASC final rule with established the policy that all other applicable services for those hospitals comment period (80 FR 70526 through applicable adjustments to the OPPS that fail to meet the Hospital OQR 70538) and section XIV. of the CY 2017 national unadjusted payment rates Program reporting requirements. We OPPS/ASC final rule with comment apply when the OPD fee schedule also proposed to continue to apply all period (81 FR 79797 through 79826) for increase factor is reduced for hospitals other applicable standard adjustments an overview of the regulatory history of that fail to meet the requirements of the to the OPPS national unadjusted the ASCQR Program. Hospital OQR Program. For example, payment rates for hospitals that fail to B. ASCQR Program Quality Measures the following standard adjustments meet the requirements of the Hospital apply to the reduced national OQR Program. Similarly, we proposed 1. Considerations in the Selection of unadjusted payment rates: the wage to continue to calculate OPPS outlier ASCQR Program Quality Measures index adjustment; the multiple eligibility and outlier payment based on We refer readers to the CY 2013 procedure adjustment; the interrupted the reduced payment rates for those OPPS/ASC final rule with comment procedure adjustment; the rural sole hospitals that fail to meet the reporting period (77 FR 68493 through 68494) for community hospital adjustment; and the requirements. a detailed discussion of the priorities we adjustment for devices furnished with We invited public comments on these consider for ASCQR Program quality full or partial credit or without cost. proposals but no comments were measure selection. We did not propose Similarly, OPPS outlier payments made received. For the CY 2018 OPPS, the any changes to this policy. for high cost and complex procedures final reporting ratio is 0.980, calculated will continue to be made when outlier by dividing the final reduced 2. Accounting for Social Risk Factors in criteria are met. For hospitals that fail to conversion factor of 77.064 by the final the ASCQR Program meet the quality data reporting full conversion factor of 78.636. We are We understand that social risk factors requirements, the hospitals’ costs are finalizing the rest of our proposal such as income, education, race and compared to the reduced payments for without modification. ethnicity, employment, disability, purposes of outlier eligibility and community resources, and social XIV. Requirements for the Ambulatory payment calculation. We established support (certain factors of which are Surgical Center Quality Reporting this policy in the OPPS beginning in the also sometimes referred to as (ASCQR) Program CY 2010 OPPS/ASC final rule with socioeconomic status (SES) factors or comment period (74 FR 60642). For a A. Background socio-demographic status (SDS) factors) complete discussion of the OPPS outlier play a major role in health. One of our 1. Overview calculation and eligibility criteria, we core objectives is to improve beneficiary refer readers to section II.G. of this final We refer readers to section XIII.A.1. of outcomes including reducing health rule with comment period. this final rule with comment period for disparities, and we want to ensure that 2. Reporting Ratio Application and a general overview of our quality all beneficiaries, including those with Associated Adjustment Policy for CY reporting programs. social risk factors, receive high quality 2018 2. Statutory History of the ASCQR care. In addition, we seek to ensure that Program the quality of care furnished by In the CY 2018 OPPS/ASC proposed providers and suppliers is assessed as rule (82 FR 33684 through 33685), we We refer readers to section XIV.K.1. of fairly as possible under our programs proposed to continue our established the CY 2012 OPPS/ASC final rule with while ensuring that beneficiaries have policy of applying the reduction of the comment period (76 FR 74492 through adequate access to excellent care. OPD fee schedule increase factor 74494) for a detailed discussion of the We have been reviewing reports through the use of a reporting ratio for statutory history of the ASCQR Program. prepared by the Office of the Assistant those hospitals that fail to meet the Secretary for Planning and Evaluation Hospital OQR Program requirements for 3. Regulatory History of the ASCQR Program (ASPE) 77 and the National Academies the full CY 2018 annual payment update of Sciences, Engineering, and Medicine We seek to promote higher quality factor. For the CY 2018 OPPS, the on the issue of measuring and and more efficient health care for proposed reporting ratio was 0.980, accounting for social risk factors in beneficiaries. This effort is supported by calculated by dividing the proposed CMS’ value-based purchasing and the adoption of widely-agreed-upon reduced conversion factor of 74.953 by quality reporting programs, and quality measures. We have worked with the proposed full conversion factor of considering options on how to address relevant stakeholders to define measures 76.483. We proposed to continue to the issue in these programs. On of quality in almost every healthcare apply the reporting ratio to all services December 21, 2016, ASPE submitted a calculated using the OPPS conversion setting and currently measure some factor. For the CY 2018 OPPS, we aspect of care for almost all Medicare 77 Office of the Assistant Secretary for Planning proposed to apply the reporting ratio, beneficiaries. These measures assess and Evaluation. 2016. Report to Congress: Social when applicable, to all HCPCS codes to structural aspects of care, clinical Risk Factors and Performance Under Medicare’s which we have proposed status processes, patient experiences with Value-Based Purchasing Programs. 21 Dec. 2016. Available at: https://aspe.hhs.gov/pdf-report/report- indicator assignments of ‘‘J1’’, ‘‘J2’’, ‘‘P’’, care, and outcomes. We have congress-social-risk-factors-and-performance- ‘‘Q1’’, ‘‘Q2’’, ‘‘Q3’’, ‘‘R’’, ‘‘S’’, ‘‘T’’, ‘‘V’’, implemented quality measure reporting under-medicares-value-based-purchasing- and ‘‘U’’ (other than new technology programs for multiple settings of care. programs.
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Report to Congress on a study it was concerned about holding providers to would be most appropriate for required to conduct under section 2(d) different standards for the outcomes of accounting for social risk factors. of the Improving Medicare Post-Acute their patients with social risk factors Comment: Many commenters Care Transformation (IMPACT) Act of because we do not want to mask expressed support for CMS’ effort to 2014. The study analyzed the effects of potential disparities or minimize address social risk factors in the ASCQR certain social risk factors of Medicare incentives to improve the outcomes for Program, noting that social risk factors beneficiaries on quality measures and disadvantaged populations. Keeping are powerful drivers of care provision measures of resource use used in one or this concern in mind, in the proposed and clinical outcomes. more of nine Medicare value-based rule we sought public comment on One commenter recommended that purchasing programs.78 The report also whether we should account for social CMS apply risk adjustment by included considerations for strategies to risk factors in the ASCQR Program, and stratifying providers into groups by account for social risk factors in these if so, what method or combination of proportion of at-risk patients, noting programs. In a January 10, 2017 report methods would be most appropriate for that this approach does not require released by the National Academies of accounting for social risk factors. measure-level research. Another Sciences, Engineering, and Medicine, Examples of methods include: commenter recommended that CMS the body provided various potential Confidential reporting to providers of determine whether or not social risk methods for accounting for social risk measure rates stratified by social risk factor disparities exist in the ASC factors, including stratified public factors; public reporting of stratified setting prior to committing to adjusting reporting.79 measure rates; and potential risk any measures for these factors, and that As noted in the FY 2017 IPPS/LTCH adjustment of a particular measure as CMS rely on data elements existing in PPS final rule, the NQF has undertaken appropriate based on data and evidence. CMS databases. A few commenters a 2-year trial period in which new In addition, we requested public recommended that CMS provide ASCs measures, measures undergoing comment on which social risk factors with both risk-adjusted and unadjusted maintenance review, and measures might be most appropriate for reporting data in order to allow for transparency. endorsed with the condition that they stratified measure scores and/or One commenter noted that better data enter the trial period can be assessed to potential risk adjustment of a particular sources for socioeconomic status are determine whether risk adjustment for measure. Examples of social risk factors needed, including patient-level and selected social risk factors is appropriate include, but are not limited to, dual community-level data sources, and that for these measures. This trial entailed eligibility/low-income subsidy, race and measure-specific risk adjustment temporarily allowing inclusion of social ethnicity, and geographic area of methodologies are appropriate. Finally, risk factors in the risk-adjustment residence. We sought comments on one commenter noted that risk approach for some performance which of these factors, including current adjustment should balance fair measures. Since publication of the data sources where this information measurement with ensuring that proposed rule, we have learned that the would be available, could be used alone disparities are not masked. National Quality Forum (NQF) has or in combination, and whether other Response: We appreciate all the concluded their initial trial on risk data should be collected to better comments and interest in this topic. As adjustment for quality measures.80 capture the effects of social risk. We will we have previously stated regarding risk Based on the findings from the initial take commenters’ input into adjustment of publicly reported data for trial, we have been informed that the consideration as we continue to assess these factors, we are concerned about NQF intends to continue its work to the appropriateness and feasibility of holding providers and suppliers to evaluate the impact of social risk factor accounting for social risk factors in the different standards for the outcomes of adjustment on intermediate outcome ASCQR Program. We note that any such their patients with social risk factors, and outcome measures for an additional changes would be proposed through because we do not want to mask three years. We understand that the future notice and comment rulemaking. potential disparities or minimize incentives to improve outcomes for extension of this work will allow NQF We look forward to working with disadvantaged populations. With to determine further how to effectively stakeholders as we consider the issue of respect to public reporting, while we account for social risk factors through accounting for social risk factors and agree with commenters and believe it is risk adjustment and other strategies in reducing health disparities in CMS important to avoid a scenario in which quality measurement. programs. Of note, implementing any of As we continue to consider the the above methods would be taken into underlying disparities are masked rather analyses and recommendations from consideration in the context of how this than addressed, we also agree with these reports and the results of the NQF and other CMS programs operate (for commenters who support the public reporting of risk-adjusted data. We trial on risk adjustment for quality example, data submission methods, appreciate the need to balance risk measures, we are continuing to work availability of data, statistical adjustment as a strategy to account for with stakeholders in this process. As we considerations relating to reliability of social risk factors with the concern that have previously communicated, we are data calculations, among others), so we also welcome comment on operational risk adjustment could minimize 78 Ibid. considerations. CMS is committed to incentives and reduce efforts to address 79 National Academies of Sciences, Engineering, ensuring that its beneficiaries have disparities for patients with social risk and Medicine. 2017. Accounting for social risk access to and receive excellent care, and factors. We believe that the path forward factors in Medicare payment. Washington, DC: The that the quality of care furnished by should incentivize improvements in National Academies Press. providers and suppliers is assessed health outcomes for disadvantaged 80 NQF. NQF Initiative to Determine the Impact of Adjusting Healthcare Performance Measures for fairly in CMS programs. populations while ensuring that Social Risk Factors Highlights Successes, We received extensive comments in beneficiaries have access to excellent Opportunities. Available at: https:// response to our request for public care. We will consider all suggestions as www.qualityforum.org/News_And_Resources/Press_ comment on whether we should we continue to assess the issue of Releases/2017/NQF_Initiative_to_Determine_the_ Impact_of_Adjusting_Healthcare_Performance_ account for social risk factors in the accounting for social risk factors within Measures_for_Social_Risk_Factors_Highlights_ ASCQR Program, and if so, what individual measures and the program as Successes,_Opportunities.aspx. method or combination of methods a whole, and will actively perform
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additional research and monitor for care furnished by providers and remove a total of three measures for the trends to prevent unintended suppliers is assessed fairly in CMS CY 2019 payment determination and consequences. We intend to conduct programs. subsequent years: (1) ASC–5: further analyses on the impact of Comment: Some commenters Prophylactic Intravenous (IV) Antibiotic different approaches to accounting for recommended that CMS consider Timing; (2) ASC–6: Safe Surgery social risk factors in quality programs. recommendations from NQF, ASPE, and Checklist Use; and (3) ASC–7: ASC Comment: Many commenters the Agency for Healthcare Research and Facility Volume Data on Selected recommended several social variables Quality (AHRQ). Procedures. These proposals are and comorbidities, including: Body Response: Any proposals would be discussed in more detail below. mass index; race; smoking status; age; made in future rulemaking after further gender; back pain; pain in non-operative research and continued stakeholder (1) Removal of ASC–5: Prophylactic lower extremity joint; health risk status; engagement including from NQF. In Intravenous (IV) Antibiotic Timing mental health factors; chronic narcotic addition, we look forward to working Beginning With the CY 2019 Payment use; socioeconomic status; and pre- with all stakeholders, including NQF, Determination procedure ambulatory status. ASPE, the National Academy of Commenters also recommended that Medicine, and AHRQ. We refer readers to the CY 2012 future risk variables could include We thank all of the commenters for OPPS/ASC final rule with comment literacy, marital status, live-in home their input and will consider all period (76 FR 74499 through 74501) support, family support structure, and suggestions as we continue to assess the where we adopted ASC–5: Prophylactic home health resources. One commenter issue of accounting for social risk factors Intravenous (IV) Antibiotic Timing recommended that the following within individual measures, the ASCQR measure (formerly NQF #0264) variables not be used: American Society Program as a whole, and across CMS beginning with the CY 2014 payment of Anesthesiologists score; range of quality programs. determination and finalized the motion; and mode of patient-reported 3. Policies for Retention and Removal of measure’s data collection and data outcome measure collection. One Quality Measures From the ASCQR submission timelines (76 FR 74515 commenter expressed concern with the Program through 74516). This measure assesses use of dual eligible status as a factor, whether intravenous antibiotics given noting that it does not identify or a. Retention of Previously Adopted for prevention of surgical site infection address the specific factors that result in ASCQR Program Measures were administered on time per clinical higher spending and/or poorer health We previously adopted a policy that guidelines. outcomes. quality measures adopted for an ASCQR Response: We appreciate commenters’ Based on our analysis of ASCQR Program measure set for a previous Program measure data for CY 2014 recommendations regarding specific payment determination year be retained through 2016 encounters, ASC social risk factor variables and will in the ASCQR Program for measure sets performance on this measure is so high consider them as we continue exploring for subsequent payment determination and unvarying that meaningful options for accounting for social risk years, except when they are removed, distinctions in improvement cannot be factors in the ASCQR Program. suspended, or replaced as indicated (76 Comment: Several commenters FR 74494 and 74504; 77 FR 68494 made; as a result, we believe this recommended that CMS consider through 68495; 78 FR 75122; and 79 FR measure meets removal criterion potential administrative complexities as 66967 through 66969). We did not number one under the ASCQR well as patient impact when propose any changes to this policy. Program’s finalized measure removal implementing risk-adjustment criteria. The ASCQR Program previously methodologies. b. Measure Removal finalized two criteria for determining Response: As we consider the We refer readers to the CY 2015 when a measure is ‘‘topped out:’’ (1) feasibility of collecting patient-level OPPS/ASC final rule with comment When there is statistically data and the impact of strategies to period (79 FR 66967 through 66969) and indistinguishable performance at the account for social risk factors through 42 CFR 416.320 for a detailed 75th and 90th percentiles of national further analysis, we will also continue discussion of the process for removing facility performance; and (2) when the to evaluate the reporting burden on adopted measures from the ASCQR measure’s truncated coefficient of patients and providers. We reiterate that Program. We did not propose any variation (COV) is less than or equal to we are committed to ensuring that CMS changes to this process. 0.10 (79 FR 66968 through 66969). beneficiaries have access to and receive In the CY 2018 OPPS/ASC proposed These analyses are captured in the table excellent care and that the quality of rule (82 FR 33687), we proposed to below.
ASC–5: PROPHYLACTIC INTRAVENOUS (IV) ANTIBIOTIC TIMING TOPPED OUT ANALYSIS
Number of 75th 90th Truncated Encounters ASCs percentile percentile COV
CY 2014 ...... 2,206 100.000 100.000 0.02633 CY 2015 ...... 2,196 100.000 100.000 0.03289 CY 2016 ...... 2,158 100.000 100.000 0.02619
As displayed in the table above, there Timing measure, and the truncated out’’ measure criteria for the ASCQR is no distinguishable difference in ASC coefficient of variation has been below Program. performance between the 75th and 90th 0.10 since 2014. Therefore, the ASC–5: Furthermore, we note that the NQF percentiles under the ASC–5: Prophylactic Intravenous (IV) Antibiotic endorsement was removed on February Prophylactic Intravenous (IV) Antibiotic Timing measure meets both ‘‘topped 13, 2015; in its discussion of whether to
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continue endorsement for the ASC–5: this measure reduces administrative 2019 payment determination and Prophylactic Intravenous (IV) Antibiotic burden. subsequent years, as proposed. Timing measure, the Surgery Standing Response: We thank the commenters (2) Removal of ASC–6: Safe Surgery Committee also noted that ASC for their support. Checklist Use Beginning With the CY performance on this measure was very Comment: One commenter opposed 2019 Payment Determination high, with 99 percent of facilities the proposed removal of ASC–5: meeting the timely antibiotic Prophylactic Intravenous (IV) Antibiotic We refer readers to the CY 2012 administration threshold in CY 2013.81 Timing measure. The commenter noted OPPS/ASC final rule with comment We believe that removal of this measure that the measure provides value and period (76 FR 74505 through 74507 and from the ASCQR Program measure set is recommended that the measure be 74509), where we adopted the ASC–6: appropriate, as there is little room for retained in the ASCQR Program despite Safe Surgery Checklist Use measure improvement and removal would having ‘‘topped-out’’ status. beginning with the CY 2015 payment alleviate maintenance costs and Response: We understand determination. This structural measure administrative burden to ASCs. As such, commenter’s concern with removing the of facility process assesses whether an we believe the burdens outweigh the ASC–5: Prophylactic Intravenous (IV) ASC employed a safe surgery checklist benefits of keeping the measure in the Antibiotic Timing measure, and agree that covered each of the three critical ASCQR Program. Therefore, in the CY that the data captured under the ASC– perioperative periods (prior to 2018 OPPS/ASC proposed rule (82 FR 5 measure could be useful in selecting administering anesthesia, prior to skin 33687), we proposed to remove the an ASC at which to receive care. incision, and prior to patient leaving the ASC–5: Prophylactic Intravenous (IV) However, we believe that removal of operating room) for the entire data Antibiotic Timing measure for the CY this measure from the ASCQR Program collection period. 2019 payment determination and measure set is appropriate as there is Based on our analysis of ASCQR subsequent years. Furthermore, we note little room for improvement, as shown Program measure data for CYs 2014 to that a similar measure was removed by our data in the table above, and 2016 encounters, the ASC–6: Safe from the Hospital OQR Program in the removal would alleviate maintenance Surgery Checklist Use measure meets CY 2015 OPPS/ASC final rule with costs and administrative burden to our first criterion for measure removal comment period (79 FR 66942 through ASCs. Overall, we believe the burdens that measure performance is so high and 66944) due to topped-out status. outweigh the benefits of keeping the unvarying that meaningful distinctions We invited public comment on our measure in the ASCQR Program, as and improvements in performance can proposal to remove the ASC–5: stated in our proposal. In response to no longer be made. The ASCQR Program Prophylactic Intravenous (IV) Antibiotic concerns that the measure adds value, previously finalized two criteria for Timing measure for the CY 2019 we note that Prophylactic Intravenous determining when a measure is ‘‘topped payment determination and subsequent (IV) Antibiotic Timing measure data are out:’’ (1) When there is statistically years as discussed above. collected and publicly reported by the indistinguishable performance at the Comment: Many commenters ASC Quality Collaboration. 75th and 90th percentiles of national supported the proposal to remove the After consideration of the public facility performance; and (2) when the ASC–5: Prophylactic Intravenous (IV) comments we received, we are measure’s truncated coefficient of Antibiotic Timing measure, and agreed finalizing the proposal to remove the variation is less than or equal to 0.10 (79 with CMS’ rationale that the measure ASC–5: Prophylactic Intravenous (IV) FR 66968 through 66969). These does not add value and that removal of Antibiotic Timing measure for the CY analyses are captured in the table below.
ASC–6—SAFE SURGERY CHECKLIST USE PERFORMANCE ANALYSIS
Number of 75th 90th Truncated Encounters ASCs Rate percentile percentile COV
CY 2012 ...... 4,356 0.989 100.000 100.000 0.106 CY 2013 82 ...... (*) (*) (*) (*) (*) CY 2014 ...... 4,328 0.997 100.000 100.000 0.050 CY 2015 ...... 4,305 0.998 100.000 100.000 0.043
Based on the analysis above the that removal of this measure from the Therefore, in the CY 2018 OPPS/ASC national rate of ‘‘Yes’’ response for the ASCQR Program measure set is proposed rule (82 FR 33688), we ASC–6: Safe Surgery Checklist Use appropriate, as there is little room for proposed to remove ASC–6: Safe measure is nearly 1.0, or 100 percent, improvement. In addition, removal of Surgery Checklist Use from the ASCQR nationwide, and has remained at this this measure would alleviate the Program measure set beginning with the level for the last 2 years. In addition, maintenance costs and administrative CY 2019 payment determination. We there is no distinguishable difference in burden to ASCs associated with also refer readers to section XIII.B.4.c.(6) ASC performance between the 75th and retaining the measure. As such, we of this final rule with comment period, 90th percentiles under measure, and the believe the burdens of this measure where the Hospital OQR Program is truncated coefficient of variation has outweigh the benefits of keeping the removing a similar measure. been below 0.10 since 2014. We believe measure in the Program.
81 NQF. ‘‘NQF-Endorsed Measures for Surgical measures; therefore, we lack performance data for Content-Disposition&blobheadervalue1= Procedures.’’ Technical Report. Available at: http:// the ASC–6 measure for this year of the ASCQR attachment%3Bfilename%3DASC_wbnr_prsntn_ www.qualityforum.org/Publications/2015/02/NQF- Program. Available at: https://www.qualitynet.org/ 121813_1ppg.pdf&blobcol=urldata&blobtable= _ _ _ _ Endorsed Measures for Surgical Procedures.aspx. dcs/BlobServer?blobkey=id&blobnocache=true& MungoBlobs. 82 We note that no performance data was blobwhere=1228890196351&blobheader= collected for CY 2013 events for the Web-based multipart%2Foctet-stream&blobheadername1=
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We invited public comment on our this final rule where we are finalizing alleviate the maintenance costs and proposal to remove the ASC–6: Safe removal of a similar measure from the administrative burden to ASCs Surgery Checklist Use measure for the Hospital OQR Program. associated with retaining the measure. CY 2019 payment determination and As such, we believe the burdens of this (3) Removal of ASC–7: ASC Facility subsequent years as discussed above. measure outweigh the benefits of Volume Data on Selected Procedures Comment: Many commenters keeping the measure in the ASCQR supported the proposal to remove the Beginning With the CY 2019 Payment Determination Program. Therefore, in the CY 2018 ASC–6: Safe Surgery Checklist Use OPPS/ASC proposed rule (82 FR 33688), measure, and agreed with our rationale We refer readers to the CY 2012 we proposed to remove ASC–7: ASC that the measure does not add value and OPPS/ASC final rule with comment Facility Volume Data on Selected that removal would reduce period (76 FR 74507 through 74509), Procedures from the ASCQR Program administrative burden. where we adopted the ASC–7: ASC beginning with the CY 2019 payment Response: We thank the commenters Facility Volume Data on Selected determination. We refer readers to for their support. Procedures measure beginning with the section XIII.B.4.c.(2) of this final rule Comment: A few commenters CY 2015 payment determination. This with comment period where we are opposed the proposed removal of the structural measure of facility capacity removing a similar measure from the ASC–6: Safe Surgery Checklist Use collects surgical procedure volume data Hospital OQR Program. measure, noting that this measure on six categories of procedures We invited public comment on our provides value and recommending frequently performed in the ASC setting proposal to remove the ASC–7: ASC retention of this measure in the ASCQR (76 FR 74507). Facility Volume Data on Selected We adopted the ASC–7: ASC Facility Program. One commenter expressed Procedures measure for the CY 2019 concern that high performance on the Volume Data on Selected Procedures payment determination and subsequent measure does not indicate whether measure based on evidence that volume years as discussed above. perioperative communication among of surgical procedures, particularly of Comment: Many commenters team members is effective, and high-risk surgical procedures, is related supported the proposal to remove the recommended that CMS retain the to better patient outcomes, including ASC–7: ASC Facility Volume Data on measure until there is further evidence decreased medical errors and mortality of whether the use of a safe surgery (76 FR 74507). We further stated our Selected Procedures measure and agreed checklist is supporting effective belief that publicly reporting volume with CMS’ rationale that the measure perioperative communication. data would provide patients with does not add value and that its removal Response: While we agree the ASC–6: beneficial performance information to reduces administrative burden. Safe Surgery Checklist Use measure use in selecting a care provider. Response: We thank the commenters captures data patients may find useful However, over time, we have adopted, for their support. in comparing ASCs while selecting an and intend to continue to adopt, more Comment: A few commenters ASC for their care, we believe that measures assessing ASCs’ performance opposed the proposal to remove the removal of this measure from the on specific procedure types, like ASC– ASC–7: ASC Facility Volume Data on ASCQR Program measure set is 14. As stated below, we believe Selected Procedures measure. One appropriate as there is little room for measures on specific procedure types commenter cited concern that removal improvement, as shown by our data in will provide patients with more of this measure will limit the the table above. In addition, removal of valuable ASC performance data. These availability of important data that this measure would alleviate the types of measures are also more strongly informs comparative research, outcomes maintenance costs and administrative associated with desired patient research, and that this measure provides burden to ASCs. Therefore, overall, we outcomes for the particular topic. For immediate consumer value. Moreover, believe the burden outweighs the example, in the CY 2017 OPPS/ASC the commenter expressed concern that benefits of keeping the measure in the final rule with comment period (81 FR reducing the data available will interfere ASCQR Program, as stated in our 79801 through 79803), we adopted with the growing acceptance of ASC- proposal. We also note that high ASC–14: Unplanned Anterior based procedures. Another commenter performance on the ASC–6: Safe Vitrectomy, a measure assessing patient noted that the measure is not overly Surgery Checklist Use measure does not outcomes following ophthalmologic burdensome and that it is helpful for indicate whether perioperative procedures, and proposed to adopt a strategic planning. communication among team members is second ophthalmology-specific Response: While we believe that effective; this measure is not specified measure, ASC–16: Toxic Anterior continuing to collect and publicly report to assess the effectiveness of a team’s Segment Syndrome, in the CY 2018 facility volume data would provide communication, only whether a safe proposed rule (82 FR 33689 through patients with beneficial performance surgery checklist is used at the ASC. 33691). We believe these procedure- information to use in selecting a care Therefore, we do not believe continuing type-specific measures provide patients provider, over time, we have adopted, to collect—or, conversely, ceasing to with more valuable ASC performance and intend to continue to adopt, more collect—data under this measure will data than the ASC–7: ASC Facility measures assessing ASCs’ performance assess or affect the effectiveness of Volume Data on Selected Procedures on specific procedure types. In addition, perioperative communication within measure in selecting an ASC for their removal of this measure would alleviate ASCs. care. For this reason, we believe the the maintenance costs and After consideration of the public ASC–7: ASC Facility Volume Data on administrative burden to ASCs comments we received, we are Selected Procedures measure meets our associated with retaining the measure. finalizing the proposal to remove ASC– second criterion for removal from the As such, although we recognize the 6: Safe Surgery Checklist Use from the program; specifically, that there are value of the measure for research, ASCQR Program measure set beginning other measures available that are more strategic planning, and in demonstrating with the CY 2019 payment strongly associated with desired patient the value of ASC-based procedures, determination, as proposed. We also outcomes for the particular topic. In overall we believe the burden of this refer readers to section XIII.B.4.c.(6) of addition, removal of this measure would measure outweighs the benefits of
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keeping the measure in the ASCQR that is not adequately addressed in our quality, patient-centered care actually Program as stated in our proposal. current measure set and will be useful takes place. After consideration of the public to assess aspects of care where the Response: We agree that patient comments we received, we are patient is the best or only source of experience of care data is valuable in finalizing our proposal to remove ASC– information. assessing the quality of care provided at 7: ASC Facility Volume Data on Further, we continue to believe these an ASC and assisting patients in Selected Procedures from the ASCQR measures will enable objective and selecting a provider or supplier for their Program beginning with the CY 2019 meaningful comparisons between ASCs. care. However, we seek to ensure the payment determination, as proposed. Therefore, we proposed to delay value of this data is appropriately balanced against the implementation 4. Delaying Implementation of ASC– implementation of ASC–15a–e and operational burdens imposed to 15a–e: Outpatient and Ambulatory beginning with the CY 2020 payment collect and submit these data. As we Surgery Consumer Assessment of determination (CY 2018 data collection) stated in the proposed rule, we believe Healthcare Providers and Systems (OAS until further action in future delaying implementation of the OAS CAHPS) Survey-Based Measures rulemaking. We also refer readers to CAHPS Survey will provide additional Beginning With the CY 2020 Payment section XIII.B.5. of this final rule with time to assess these issues before Determination comment period where we are finalizing a similar policy in the Hospital OQR moving forward. We refer readers to the CY 2017 Program. Comment: A few commenters OPPS/ASC final rule with comment We invited public comment on our recommended that the survey be period where we adopted ASC–15a–e proposal to delay the OAS CAHPS voluntary indefinitely or until (81 FR 79803 through 79817), and Survey-based measures beginning with implementation issues with the survey finalized data collection and data the CY 2020 payment determination as are addressed. One commenter submission timelines (81 FR 79822 discussed above. recommended that CMS delay through 79824). These measures assess implementation of the OAS CAHPS Comment: Many commenters patients’ experience with care following indefinitely and instead increase the supported the proposal to delay a procedure or surgery in an ASC by number of surveyors that inspect ASCs. implementation of the OAS CAHPS rating patient experience as a means for Another commenter recommended that Survey and noted that if the survey empowering patients and improving the CMS adopt the CAHPS surgical care could be improved, ASCs would benefit quality of their care. survey as a survey option. In the CY 2018 OPPS/ASC proposed from having their scores available for Response: We thank the commenters rule (82 FR 33688), we proposed to comparison to hospital outpatient for their recommendations, and we will delay implementation of the Outpatient departments. One commenter agreed take these comments under and Ambulatory Surgery Consumer that an analysis of the national consideration as we craft future policy. Assessment of Healthcare Providers and implementation will provide valuable We do not believe that inspectors Systems (OAS CAHPS) Survey-based information. Another commenter noted replace a patient-experience-of-care Measures (ASC–15a–e) beginning with that the high volume of facilities and survey, because inspections and surveys the CY 2020 payment determination (CY hospitals participating in the voluntary collect different information. 2018 data collection) until further action national implementation indicates that Specifically, we believe that patient in future rulemaking. Since our the data collection burden of the survey experience data is an important category adoption of these measures, we have is low. of information to collect and would not come to believe that we need to collect Response: We thank the commenters be captured by surveyors. Further, we more operational and implementation for their support, and agree that an believe a patient experience of care data. Specifically, we want to ensure analysis of the national implementation survey will provide important that the survey measures appropriately of OAS CAHPS Survey will provide information to not just providers, but account for patient response rates, both valuable information as we continue to also patients and the general public. aggregate and by survey administration assess the survey. We also acknowledge Therefore, we will continue to work method; reaffirm the reliability of that comparing scores between ASCs towards a successful implementation of national implementation of OAS and hospital outpatient departments a patient experience survey. In addition, CAHPS Survey data; and appropriately may be useful to ASCs and that some we acknowledge the commenter’s account for the burden associated with ASCs may find the survey to have only suggestion that we adopt the surgical administering the survey in the limited burden. However, as discussed CAHPS survey and we will consider outpatient setting of care. We note that below, in order to be responsive to this recommendation. commenters expressed concern over the concerns about vendor costs and to Comment: A few commenters burden associated with the survey in the review the results of the national expressed concern about the burden CY 2017 OPPS/ASC final rule with implementation, we are finalizing our associated with collecting 300 surveys comment period (81 FR 79810). We proposal to delay implementation of the and requested that only 100 surveys be believe that the voluntary national OAS CAHPS Survey. required. Other commenters noted that implementation of the survey, which Comment: A few commenters the survey is unnecessarily long, which began in January 2016, would provide opposed the proposal to delay could reduce response rates or skew valuable information moving forward. implementation of the OAS CAHPS results if only patients with negative We plan to conduct analyses of the Survey, noting the importance of patient feedback respond, and that not all of the national implementation data to experience data. One commenter noted questions are relevant. Some undertake any necessary modifications that the survey assesses areas of care not commenters noted that the use of a to the survey tool and/or CMS systems. yet adequately addressed and that third-party vendor is too costly and We believe it is important to allow time patient experience of care is a priority could lead to more impersonal contacts for any modifications before requiring area. Another commenter noted a belief with patients than if ASCs surveyed the survey under the ASCQR Program. that the use of surveys about patient patients directly. Several commenters However, we continue to believe that experience in health care settings is the recommended that vendors should these measures address an area of care best way to examine whether high- provide electronic or email options for
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conducting the OAS CAHPS Survey in administer the survey; the survey would Measures (ASC–15a–e) beginning with order to increase response rates. Other still be administered through vendors. the CY 2020 payment determination (CY commenters recommended that CMS In addition, we acknowledge 2018 data collection) until further action administer the survey on its Web site. commenters concerns that ASCs would in future rulemaking, as proposed. We One commenter noted concern that not receive immediate feedback from refer readers to section XIII.B.5. of this timely results are not provided. A few patients that is obtained through the final rule with comment where we are commenters expressed concern that the survey. Finally, we acknowledge the also finalizing delay of the OAS CAHPS CPT codes included in the eligibility concern about the use of CPT codes, Survey-based measures in the Hospital criteria for the survey are not always including those for procedures that OQR Program. applicable. patients may not perceive as surgery. Response: While Web-based surveys We note that many CPT codes have been 5. ASCQR Program Quality Measures are not available survey modes at excluded from inclusion in the OAS Adopted in Previous Rulemaking present, we are actively investigating CAHPS, including services like these modes as possible options for the application of a cast or splint, in order For the CY 2020 payment future. We are exploring whether to ensure that only patients receiving determination and subsequent years, we hospitals and ASCs receive reliable applicable procedures are surveyed.83 have previously finalized the following email addresses from patients and We thank the commenters and will take measure set. We note that this chart still whether there is adequate access to the all comments under consideration as we includes the ASC–5, ASC–6, and ASC– internet across all types of patients. craft future policy for the OAS CAHPS 7 measures, which are being finalized Ultimately, the purpose of the Survey. for removal beginning with the CY 2019 investigation is to ensure that any future After consideration of the public payment determination as discussed survey administration method does not comments we received, we are above, as well as the ASC–15a–e introduce bias in the survey process and finalizing the proposal to delay measures, which are being finalized for reduces length and burden if at all implementation of the Outpatient and delay beginning with the CY 2020 possible. Although we are investigating Ambulatory Surgery Consumer payment determination and until other modes of survey administration, Assessment of Healthcare Providers and further action as discussed above: we do not expect that CMS will directly Systems (OAS CAHPS) Survey-based
ASCQR PROGRAM MEASURE SET PREVIOUSLY FINALIZED FOR THE CY 2020 PAYMENT DETERMINATION AND SUBSEQUENT YEARS
ASC No. NQF No. Measure name
ASC–1 ...... 0263 ...... Patient Burn. ASC–2 ...... 0266 ...... Patient Fall. ASC–3 ...... 0267 ...... Wrong Site, Wrong Side, Wrong Patient, Wrong Procedure, Wrong Implant. ASC–4 ...... 0265 † ...... All-Cause Hospital Transfer/Admission. ASC–5 ...... 0264 † ...... Prophylactic Intravenous (IV) Antibiotic Timing.* ASC–6 ...... None ...... Safe Surgery Checklist Use.* ASC–7 ...... None ...... ASC Facility Volume Data on Selected Procedures.* ASC–8 ...... 0431 ...... Influenza Vaccination Coverage Among Healthcare Personnel. ASC–9 ...... 0658 ...... Endoscopy/Polyp Surveillance: Appropriate Follow-Up Interval for Normal Colonoscopy in Average Risk Pa- tients. ASC–10 ...... 0659 ...... Endoscopy/Polyp Surveillance: Colonoscopy Interval for Patients with a History of Adenomatous Polyps- Avoidance of Inappropriate Use. ASC–11 ...... 1536 ...... Cataracts: Improvement in Patient’s Visual Function within 90 Days Following Cataract Surgery.** ASC–12 ...... 2539 ...... Facility 7-Day Risk-Standardized Hospital Visit Rate after Outpatient Colonoscopy. ASC–13 ...... None ...... Normothermia Outcome. ASC–14 ...... None ...... Unplanned Anterior Vitrectomy. ASC–15a ...... None ...... OAS CAHPS—About Facilities and Staff.*** ASC–15b ...... None ...... OAS CAHPS—Communication About Procedure.*** ASC–15c ...... None ...... OAS CAHPS—Preparation for Discharge and Recovery.*** ASC–15d ...... None ...... OAS CAHPS—Overall Rating of Facility.*** ASC–15e ...... None ...... OAS CAHPS—Recommendation of Facility.*** † We note that NQF endorsement for this measure was removed. * Measure finalized for removal beginning with the CY 2019 payment determination, as discussed in section XIV.B.3.b. of this final rule with comment period. ** Measure voluntarily collected effective beginning with the CY 2017 payment determination as set forth in section XIV.E.3.c. of the CY 2015 OPPS/ASC final rule with comment period (79 FR 66984 through 66985). *** Measure finalized for delay in reporting beginning with the CY 2020 payment determination (CY 2018 data collection) until further action in future rulemaking as discussed in section XIV.B.4. of this final rule with comment period.
83 OASCAHPS.org. Additional Procedural Codes Available at: https://oascahps.org/General- Additional-Procedural-Codes-for-Exclusion-from- for Exclusion from the OAS CAHPS Survey. Information/Announcements/EntryId/80/ the-OAS-CAHPS-Survey.
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6. New ASCQR Program Quality TASS continue to occur, sometimes in MAP reviewed the measure (MUC15– Measures for the CY 2021 and CY 2022 clusters.87 With millions of anterior 1047) and conditionally supported it for Payment Determinations and segment surgeries being performed in the ASCQR Program pending NQF Subsequent Years the United States each year, review and endorsement.90 The MAP We refer readers to the CY 2014 measurement and public reporting have noted the high value and urgency of this OPPS/ASC final rule with comment the potential to serve as an additional measure, given many new entrants to period (78 FR 75124) for a detailed tool to drive further preventive efforts. the ambulatory surgical center space, as discussion of our approach to measure TASS is of interest to the ASCQR well as the clustering outbreaks of selection for the ASCQR Program. In the Program because cataract surgery is an TASS. The MAP also cautioned that the CY 2018 OPPS/ASC proposed rule (82 anterior segment surgery commonly measure be reviewed and endorsed by FR 33689 through 33698), we proposed performed at ASCs. In addition, the NQF before adoption into the ASCQR to adopt a total of three new measures TASS measure addresses the MAP- Program, so that a specialized standing for the ASCQR Program: one measure identified priority measure area of committee can evaluate the measure for 91 collected via a CMS web-based tool for procedure complications for the ASCQR scientific acceptability. A summary of the CY 2021 payment determination and Program.88 the MAP recommendations can be found at: https://www.qualityforum.org/ subsequent years (ASC–16: Toxic (2) Overview of Measure Anterior Segment Syndrome), and two WorkArea/linkit.aspx?LinkIdentifier= measures collected via claims for the CY We believe it is important to monitor id&ItemID=81593. 2022 payment determination and the rate of TASS in the ASC setting Sections 1833(i)(7)(B) and subsequent years (ASC–17: Hospital because ophthalmologic procedures 1833(t)(17)(C)(i) of the Act, when read Visits after Orthopedic Ambulatory such as anterior segment surgery are together, require the Secretary, except as Surgical Center Procedures; and ASC– commonly performed in this setting of the Secretary may otherwise provide, to 18: Hospital Visits after Urology care. Therefore, in the CY 2018 OPPS/ develop measures appropriate for the Ambulatory Surgical Center ASC proposed rule (82 FR 33690), we measurement of the quality of care Procedures). These measures are proposed to adopt the ASC–16: Toxic furnished by ASCs that reflect discussed in detail below. Anterior Segment Syndrome measure, consensus among affected parties and, which is based on aggregate measure to the extent feasible and practicable, a. Proposal To Adopt ASC–16: Toxic data collected by the ASC and that include measures set forth by one Anterior Segment Syndrome Beginning submitted via a CMS online data or more national consensus building With the CY 2021 Payment submission tool (QualityNet), in the entities. However, we note that section Determination ASCQR Program for the CY 2021 1833(i)(7)(B) of the Act does not require (1) Background payment determination and subsequent that each measure we adopt for the years. We expect the measure would ASCQR Program be endorsed by a Toxic Anterior Segment Syndrome promote improvement in patient care national consensus building entity, or (TASS), an acute, noninfectious over time, because measurement by the NQF specifically. Further, under inflammation of the anterior segment of coupled with transparency in publicly section 1833(i)(7)(B) of the Act, section the eye, is a complication of anterior reporting of measure information would 1833(t)(17)(C)(i) of the Act applies to the segment eye surgery that typically make patient outcomes following ASCQR Program, except as the Secretary develops within 24 hours after anterior segment procedures more may otherwise provide. Under this surgery.84 The TASS measure assesses visible to ASCs and patients and provision, the Secretary has further the number of ophthalmic anterior incentivize ASCs to incorporate quality authority to adopt non-endorsed segment surgery patients diagnosed improvement activities to reduce the measures. As stated in the CY 2012 with TASS within two days of surgery. incidence of TASS where necessary. OPPS/ASC final rule with comment Although most cases of TASS can be Section 1890A of the Act requires the period (76 FR 74465 and 74505), we treated, the inflammatory response Secretary to establish a prerulemaking believe that consensus among affected associated with TASS can cause serious process with respect to the selection of parties can be reflected through means damage to intraocular tissues, resulting certain categories of quality and other than NQF endorsement, including in vision loss.85 Prevention requires efficiency measures. Under section consensus achieved during the measure careful attention to solutions, 1890A(a)(2) of the Act, the Secretary development process, consensus shown medications, and ophthalmic devices must make available to the public by through broad acceptance and use of and to cleaning and sterilization of December 1 of each year a list of quality measures, and consensus through public surgical equipment because of the and efficiency measures that the comment. We believe this measure numerous potential etiologies.86 Despite Secretary is considering for the meets these statutory requirements. a recent focus on prevention, cases of Medicare program. The ASC–16 The proposed ASC–16: Toxic Anterior measure was included on the 2015 MUC Segment Syndrome measure is not NQF- 84 Centers for Disease Control and Prevention. 89 Toxic Anterior Segment Syndrome after Cataract list and reviewed by the MAP. The endorsed. However, this measure is Surgery—Maine, 2006. MMWR. Morbidity and maintained by the ASC Quality Mortality Weekly Report. 2007 Jun 29;56(25):629– 87 Moyle W, Yee RD, Burns JK, Biggins T. Two Collaboration,92 an entity recognized 630. Consecutive Clusters of Toxic Anterior Segment within the community as an expert in 85 Breebaart AC, Nuyts RM, Pels E, Edelhauser Syndrome. Optometry and Vision Science. 2013 measure development for the ASC HF, Verbraak FD. Toxic Endothelial Cell Jan;90(1):e11–23. Destruction of the Cornea after Routine 88 National Quality Forum. ‘‘MAP 2017 Extracapsular Cataract Surgery. Archives of Considerations for Implementing Measures in 90 National Quality Forum. 2016 Spreadsheet of Ophthalmology 1990;108:1121–1125. Federal Programs: Hospitals.’’ Report. 2017. Final Recommendations to HHS and CMS. 86 Hellinger WC, Bacalis LP, Erdhauser HF, Available at: http://www.qualityforum.org/map/ Available at: https://www.qualityforum.org/ Mamalis N, Milstein B, Masket S. ASCRS Ad Hoc under ‘‘Hospitals—Final Report.’’ WorkArea/linkit.aspx?LinkIdentifier=id&ItemID= Task Force on Cleaning and Sterilization of 89 National Quality Forum. 2015 Measures Under 81593. Intraocular Instruments: Recommended Practices Consideration List. National Quality Forum, Dec. 91 Ibid. for Cleaning and Sterilizing Intraocular Surgical 2016. Available at: http://www.qualityforum.org/ 92 ASC Quality Collaboration. ‘‘ASC Quality Instruments. Journal of Cataract and Refractive 2015_Measures_Under_Consideration.aspx, under Collaboration.’’ Available at: http:// Surgery. 2007 Jun;33(6):1095–1100. ‘‘2015 Measures Under Consideration List (PDF).’’ www.ascquality.org/.
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setting. We believe that this measure is CY 2021 payment determination, the promote collaboration between surgeons appropriate for the measurement of data collection period would be CY and facilities and ensure that prevention quality care furnished by ASCs because 2019. We also proposed that ASCs guidelines are appropriately followed. ophthalmologic procedures are submit these data to CMS during the Another commenter noted this measure commonly performed in ASCs and, as time period of January 1 to May 15 in is currently in use as part of the ASC discussed above, the inflammatory the year prior to the affected payment Quality Collaboration’s public report of response associated with TASS can determination year. For example, for the ASC quality data, and expressed cause serious damage to patients’ vision, CY 2021 payment determination, the particular support for submission of but TASS is also preventable through submission period would be January 1, aggregated measure data for the careful attention to solutions, 2020 to May 15, 2020. We refer readers proposed ASC–16: Toxic Anterior medications, ophthalmic devices, and to to section XIV.D.3.b. of this final rule Segment Syndrome measure via cleaning and sterilization of surgical with comment period for a more QualityNet. equipment. While the ASC–16: Toxic detailed discussion of the requirements Response: We thank the commenters Anterior Segment Syndrome measure is for data submitted via a CMS online for their support. not NQF-endorsed, we believe this data submission tool. Comment: Another commenter measure reflects consensus among specifically noted the measure could affected parties, because the MAP, (4) Measure Calculation improve patient care while adding little which represents stakeholder groups, The outcome measured in the administrative burden, but also reviewed and conditionally supported proposed ASC–16: Toxic Anterior expressed concern about an ASC’s the measure 93 for use in the ASCQR Segment Syndrome measure is the ability to collect measure data if patients Program. The MAP agreed that this number of ophthalmic anterior segment do not present back to the ASC where measure is high-value and urgent in the surgery patients diagnosed with TASS their procedure was performed. current healthcare marketplace and the within 2 days of surgery. The numerator Response: We thank the commenter number of new entrants to the surgical for this measure is all anterior segment for their feedback and acknowledge that center place, as well as the clustering surgery patients diagnosed with TASS it may be difficult to collect data based outbreaks of TASS.94 Furthermore, we within 2 days of surgery. The on where patients present. believe that this measure is denominator for this measure is all Comment: One commenter expressed scientifically acceptable, because the anterior segment surgery patients. The conditional support for the proposed measure steward has completed specifications for this measure for the ASC–16: Toxic Anterior Segment reliability testing and validity ASC setting can be found at: http:// Syndrome measure pending NQF assessment of the measure.95 ascquality.org/documents/ endorsement prior to adoption. Other Specifically, an internal retrospective ASC%20QC%20 commenters expressed concern that the chart audit of the ASCs participating in Implementation%20Guide measure is not NQF-endorsed and measurement testing found no %203.2%20October%202015.pdf. recommended CMS secure NQF differences between the originally endorsement for the measure prior to submitted and re-abstracted TASS rates, (5) Cohort adopting it for use in the ASCQR providing strong evidence the measure The measure includes all patients, Program. is reliable. The measure steward also regardless of age, undergoing anterior Response: Sections 1833(i)(7)(B) and conducted a formal consensus review to segment surgery at an ASC. Additional 1833(t)(17)(C)(i) of the Act, when read assess the measure’s validity; the results methodology and measure development together, require the Secretary, except as of this assessment showed participants details are available at: http:// the Secretary may otherwise provide, to believe the measure appears to measure www.ascquality.org/ develop measures appropriate for the what it is intended to, and is defined in qualitymeasures.cfm under ‘‘ASC measurement of the quality of care a way that will allow for consistent Quality Collaboration Measures furnished by ASCs that reflect interpretation of the inclusion and Implementation Guide.’’ consensus among affected parties and, exclusion criteria from ASC to ASC. to the extent feasible and practicable, (6) Risk Adjustment that include measures set forth by one (3) Data Sources The proposed ASC–16: Toxic Anterior or more national consensus building This measure is based on aggregate Segment Syndrome measure is not risk- entities. However, we note that section measure data collected via chart- adjusted; risk adjustment for patient 1833(i)(7)(B) of the Act does not require abstraction by the ASC and submitted characteristics is not appropriate for this that each measure we adopt for the via a CMS online data submission tool measure. ASCQR Program be endorsed by a (that is, QualityNet). We invited public comment on our national consensus building entity, or We proposed that the data collection proposal to adopt the ASC–16: Toxic by the NQF specifically. Further, under period for the proposed ASC–16 Anterior Segment Syndrome measure section 1833(i)(7)(B) of the Act, section measure would be the calendar year two for the CY 2021 payment determination 1833(t)(17)(C)(i) of the Act applies to the years prior to the applicable payment and subsequent years as discussed ASCQR Program, except as the Secretary determination year. For example, for the above. may otherwise provide. Under this Comment: Some commenters provision, the Secretary has further 93 National Quality Forum. 2016 Spreadsheet of supported CMS’ proposal to adopt ASC– authority to adopt non NQF-endorsed Final Recommendations to HHS and CMS. 16: Toxic Anterior Segment Syndrome measures. As stated in the CY 2012 Available at: https://www.qualityforum.org/ WorkArea/linkit.aspx?LinkIdentifier=id&ItemID= beginning with the CY 2021 payment OPPS/ASC final rule with comment 81593. determination, citing the measure’s period (76 FR 74465 and 74505), we 94 Ibid. clinical significance and impact on believe that consensus among affected 95 AHRQ Measure Summary. Available at: https:// patients. One commenter specifically parties can be reflected through means www.qualitymeasures.ahrq.gov/summaries/ noted the measure could improve other than NQF endorsement, including summary/49582/ambulatory-surgery-percentage-of- consensus achieved during the measure ophthalmic-anterior-segment-surgery-patients- patient care while adding little diagnosed-with-toxic-anterior-segment-syndrome- administrative burden. One commenter development process, consensus shown tass-within-2-days-of-surgery. noted the measure’s potential to through broad acceptance and use of
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measures, and consensus through public TASS. One commenter expressed that this measure may not be comment. This measure is maintained concern that the proposed ASC–16: appropriate for national implementation by the ASC Quality Collaboration,96 an Toxic Anterior Segment Syndrome in the ASCQR Program. Upon further entity recognized within the community measure will not improve healthcare consideration of the difficulty of as an expert in measure development for quality because the measure provides implementing the measure, the the ASC setting. Furthermore, the ASC– data that is retrospective in nature and likelihood of applicability to only very 16 measure was included on the 2015 the commenter believes the measure specific ASC facilities where TASS MUC list 97 and reviewed by the MAP. will not assist ASCs in implementing occurs, and from incoming comments, While the ASC–16: Toxic Anterior improvement activities. we believe that the burden of the Segment Syndrome measure is not NQF- Response: We thank the commenters measure would outweigh the benefits endorsed, we believe this measure for their suggestions and note the and no longer believe that the measure reflects consensus among affected concerns about the proposal to adopt is appropriate for the ASCQR Program at parties, because the MAP, which ASC–16: Toxic Anterior Segment this time. Therefore, we are not represents stakeholder groups, reviewed Syndrome beginning with the CY 2021 finalizing this measure. However, we and conditionally supported the payment determination. While we refer readers to the ASC Quality measure 98 for use in the ASCQR believe the measure is reliable, we Collaboration, the measure steward, Program. The MAP agreed that this recognize that there are concerns over which is independently collecting and measure is high-value and urgent in the the feasibility of implementing the publicly reporting this TASS measure: current healthcare marketplace and the TASS measure. Some commenters http://ascquality.org/documents/ASC- number of new entrants to the surgical expressed concern that ASCs will have QC-Implementation-Guide-4.0- center place, as well as the clustering difficulty reporting the measure if September-2016.pdf. 99 outbreaks of TASS. patients present to another facility with Comment: One commenter Comment: Several commenters did TASS within 2 days of a procedure and recommended CMS instead enable not support adoption of the proposed we acknowledge that some cases could ASCs to learn best practices and ASC–16: Toxic Anterior Segment be missing from inclusion in the techniques from other facilities by Syndrome measure. Two commenters measure especially given the very low facilitating data-sharing among noted it may not be feasible for ASCs to incidence of TASS. In response to facilities. implement the measure due to the small concerns that ASCs will receive number of patients experiencing TASS. retrospective data on the measure, Response: We agree that data-sharing Other commenters similarly asserted rather than during the time that a among facilities could inform quality ASCs will encounter operational patient is experiencing TASS, we note improvement activities. We will difficulties incorporating the measure our belief that tracking TASS for the consider opportunities to further into their clinical workflow, because the purpose of the measure reporting would promote the sharing of best practices measure requires information sharing increase facility awareness of potential across ASCs. across clinicians in order to collect outbreaks. In addition, we disagree with After consideration of the public accurate data, making accurate data commenters that the measure relies on comments we received, we are not collection both expensive and labor- subjective or self-reported data, as data finalizing the proposal to adopt the intensive. A commenter also expressed sources for this measure include ASC–16: Toxic Anterior Segment concern that patients may not physician diagnosis and report, clinical Syndrome measure for the CY 2021 understand the difference between administrative data, paper medical payment determination and subsequent TASS and infection, leading to records, or incident/occurrence years for reasons discussed in our inaccurate data being present in charts. reports.100 responses above. Another commenter expressed concern Regarding concerns about the low The measure set for the ASCQR that the measure’s reliance on self- volume of procedures, although data Program CY 2021 payment reported data may lead to subjective show that TASS occurs in clusters, determination and subsequent years is results or manipulation, and that the these clusters do indeed include low as listed below. We note that the measure is limited to a segment of the numbers, ranging from just a few cases measures we are finalizing for removal larger ASC industry, as only very few to up to 20 cases during a year’s time.101 in this final rule with comment period ASCs will have patients presenting with As a result of this low volume, we agree are not included in this chart.
ASCQR PROGRAM MEASURE SET FINALIZED FOR THE CY 2021 PAYMENT DETERMINATION AND SUBSEQUENT YEARS ***
ASC No. NQF No. Measure name
ASC–1 ...... 0263 ...... Patient Burn. ASC–2 ...... 0266 ...... Patient Fall. ASC–3 ...... 0267 ...... Wrong Site, Wrong Side, Wrong Patient, Wrong Procedure, Wrong Implant. ASC–4 ...... 0265 † ...... All-Cause Hospital Transfer/Admission. ASC–8 ...... 0431 ...... Influenza Vaccination Coverage among Healthcare Personnel. ASC–9 ...... 0658 ...... Endoscopy/Polyp Surveillance: Appropriate Follow-Up Interval for Normal Colonoscopy in Average Risk Pa- tients.
96 ASC Quality Collaboration. ‘‘ASC Quality 98 National Quality Forum. 2016 Spreadsheet of 100 ASC Quality Measures Implementation Guide. Collaboration.’’ Available at: http:// Final Recommendations to HHS and CMS. Available at: http://ascquality.org/documents/ASC– www.ascquality.org/. Available at: https://www.qualityforum.org/ QC-Implementation-Guide-4.0-September-2016.pdf. 97 National Quality Forum. 2015 Measures Under WorkArea/linkit.aspx?LinkIdentifier=id&ItemID= 101 Moyle W, Yee RD, Burns JK, Biggins T. Two Consideration List. National Quality Forum, Dec. 81593. Consecutive Clusters of Toxic Anterior Segment 2016. Available at: http://www.qualityforum.org/ 99 2015_Measures_Under_Consideration.aspx, under Ibid. Syndrome. Optometry and Vision Science. 2013 ‘‘2015 Measures Under Consideration List (PDF).’’ Jan;90(1):e11–23.
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ASCQR PROGRAM MEASURE SET FINALIZED FOR THE CY 2021 PAYMENT DETERMINATION AND SUBSEQUENT YEARS ***—Continued
ASC No. NQF No. Measure name
ASC–10 ...... 0659 ...... Endoscopy/Polyp Surveillance: Colonoscopy Interval for Patients with a History of Adenomatous Polyps- Avoidance of Inappropriate Use. ASC–11 ...... 1536 ...... Cataracts: Improvement in Patient’s Visual Function within 90 Days Following Cataract Surgery .* ASC–12 ...... 2539 ...... Facility 7-Day Risk-Standardized Hospital Visit Rate after Outpatient Colonoscopy. ASC–13 ...... None ...... Normothermia Outcome. ASC–14 ...... None ...... Unplanned Anterior Vitrectomy. ASC–15a ...... None ...... OAS CAHPS—About Facilities and Staff .** ASC–15b ...... None ...... OAS CAHPS—Communication About Procedure.** ASC–15c ...... None ...... OAS CAHPS—Preparation for Discharge and Recovery.** ASC–15d ...... None ...... OAS CAHPS—Overall Rating of Facility.** ASC–15e ...... None ...... OAS CAHPS—Recommendation of Facility.** † We note that NQF endorsement for this measure was removed. * Measure voluntarily collected effective beginning with the CY 2017 payment determination as set forth in section XIV.E.3.c. of the CY 2015 OPPS/ASC final rule with comment period (79 FR 66984 through 66985). ** Measure reporting delayed beginning with the CY 2020 payment determination (CY 2018 data collection) and until further action in future rulemaking, as discussed in section XIV.B.4. of this final rule with comment period. *** The ASC–5, ASC–6 and ASC–7 measures are finalized for removal beginning with the CY 2019 payment determination, as discussed in section XIV.B.3.b. of this final rule with comment period.
b. Adoption of ASC–17: Hospital Visits hospitalization, and are able to return to bleeding, while others were admitted After Orthopedic Ambulatory Surgical work more quickly.106 As the number of later for issues related to pain and Center Procedures Beginning With the orthopedic procedures performed in swelling.108 Therefore, we believe CY 2022 Payment Determination ASCs increases, it is increasingly tracking and reporting these events (1) Background important to report the quality of care would facilitate efforts to lower the rate for patients undergoing these of preventable adverse events and to Reporting the quality of care provided procedures. According to Medicare improve the quality of care following at ASCs is a key priority in the context claims data, approximately seven orthopedic surgeries performed at an of growth in the number of ASCs and percent of surgeries performed in ASCs ASC. the number of procedures performed in in 2007 were orthopedic in nature, this setting. More than 60 percent of all which reflects a 77-percent increase in (2) Overview of Measure medical or surgical procedures orthopedic procedures performed at Based on the increasing prevalence of performed in 2006 were performed at ASCs from 2000 to 2007.107 orthopedic surgery in the ASC setting, ASCs; this represents a three-fold We believe measuring and reporting we believe it is important to minimize increase from the late 1990s.102 In 2015, seven-day unplanned hospital visits adverse patient outcomes associated more than 3.4 million fee-for-service following orthopedic ASC procedures with these orthopedic ASC surgeries. Medicare beneficiaries were treated at will incentivize ASCs to improve care Therefore, in the CY 2018 OPPS/ASC 5,475 Medicare-certified ASCs, and and care transitions. Patients that have proposed rule (82 FR 33692), we spending on ASC services by Medicare hospital visits that occur at or after proposed to adopt the ASC–17: Hospital and its beneficiaries amounted to 4.1 discharge from the ASC and may not be Visits after Orthopedic Ambulatory billion dollars.103 The patient readily visible to clinicians because Surgical Center Procedures measure into population served at ASCs has such patients often present to the ASCQR Program for the CY 2022 increased not only in volume, but also alternative facilities, such as emergency payment determination and subsequent in age and complexity, which can be departments where patient information years. We expect the measure would partially attributed to improvements in is not linked back to the ASC. promote improvement in patient care anesthetic care and innovations in Furthermore, many of the reasons for over time, because measurement minimally invasive surgical hospital visits following surgery at an coupled with transparency in publicly techniques.104 105 As such, ASCs have ASC are preventable; patients often reporting measure information would become the preferred setting for the present to the hospital for complications make the rate of unplanned hospital provision of low-risk surgical and of medical care, including infection, visits (emergency department visits, medical procedures in the United post-operative bleeding, urinary observation stays, and unplanned States, as many patients experience retention, nausea and vomiting, and inpatient admissions) following shorter wait times, prefer to avoid pain. One study found that of 10,032 orthopedic surgery at ASCs more visible patients who underwent orthopedic to both ASCs and patients and would 102 Cullen KA, Hall MJ, Golosinskiy A, Statistics surgery in an ASC between 1993 and incentivize ASCs to incorporate quality NFcH. Ambulatory Surgery in the United States, 2012, 121 (1.2 percent) needed attention improvement activities to reduce these 2006. National Health Statistics Report; 2009. in the emergency department in the first 103 Medicare Payment Advisory Commission unplanned hospital visits. The measure (MedPAC). Report to Congress: Medicare Payment 24 hours after discharge due to pain or also addresses the CMS National Policy. March 2017; Available at: http:// Quality Strategy domains of making care www.medpac.gov/docs/default-source/reports/ 106 Cullen KA, Hall MJ, Golosinskiy A, Statistics safer by reducing harm caused in the mar17_entirereport.pdf?sfvrsn=0. NFcH. Ambulatory Surgery in the United States, 104 Bettelli G. High Risk Patients in Day Surgery. 2006. National Health Statistics Report; 2009. delivery of care and promoting effective Minerva Anestesiologica. 2009;75(5):259–268. See 107 Goyal KS, Jain S, Buterbaugh GA, et al. The also Fuchs K. Minimally Invasive Surgery. Safety of Hang and Upper-Extremity Surgical 108 Martı´n-Ferrero MA, Faour-Martı´n O. Endoscopy. 2002;34(2):154–159. Procedures at a Freestanding Ambulatory Surgical Ambulatory surgery in orthopedics: experience of 105 Fuchs K. Minimally invasive surgery. Center. The Journal of Bone and Joint Surgery. over 10,000 patients. Journal of Orthopaedic Endoscopy. 200234(2):154159. 2016;90:600–604. Surgery. 2014;19:332–338.
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communication and coordination of reliability increased for ASCs with more appropriate NQF project has a call for care. patients; ASCs with at least 250 cases measures. We believe that this measure Section 1890A of the Act requires the showed moderate reliability, consistent is appropriate for the measurement of Secretary to establish a prerulemaking with other publicly reported Medicare quality care furnished by ASCs, because process with respect to the selection of claims-based, risk-adjusted outcome surgeries are becoming increasingly certain categories of quality and measures.113 The validity testing results common in ASCs and, as discussed efficiency measures. Under section demonstrated that the measure scores above, can signify unanticipated 1890A(a)(2) of the Act, the Secretary are valid and useful measures of ASC admissions after care provided in ASCs. must make available to the public by orthopedic surgical quality of care and Such visits are an unexpected and December 1 of each year a list of quality will provide ASCs with information that potentially preventable outcome for and efficiency measures that the can be used to improve their quality of patients with a low anticipated Secretary is considering for the care. Detailed testing results are perioperative risk. We also believe this Medicare program. The ASC–17: available in the technical report for this proposed measure reflects consensus Hospital Visits after Orthopedic measure, located at: https:// among affected parties, because it was Ambulatory Surgical Center Procedures www.cms.gov/medicare/Quality- developed with stakeholder input from measure was included on a publicly Initiatives-Patient-Assessment- a Technical Expert Panel convened by a available document entitled ‘‘List of Instruments/HospitalQualityInits/ CMS contractor as well as from the Measures under Consideration for Measure-Methodology.html. measure development public comment December 1, 2016.’’ 109 The MAP Sections 1833(i)(7)(B) and period.114 During the MAP and measure reviewed this measure (MUC16–152) 1833(t)(17)(C)(i) of the Act, when read development processes, public and recommended this measure be together, require the Secretary, except as commenters supported the measure’s refined and resubmitted prior to the Secretary may otherwise provide, to focus on assessing patient outcomes adoption, stating that testing results develop measures appropriate for the after orthopedic surgery performed in should demonstrate reliability and measurement of the quality of care ASC setting of care, and agreed that the validity at the facility level in the furnished by ASCs that reflect measure would be meaningful and 110 ambulatory surgical setting. MAP consensus among affected parties and, improve quality of care. In addition, the also recommended that this measure be to the extent feasible and practicable, ASC–17: Hospital Visits after submitted to NQF for review and that include measures set forth by one Orthopedic Ambulatory Surgical Center 111 endorsement. At the time of the or more national consensus building Procedures measure addresses the MAP- MAP’s review, this measure was still entities. However, we note that section identified priority measure area of undergoing field testing. 1833(i)(7)(B) of the Act does not require surgical complications for the ASCQR Since the MAP’s review and that each measure we adopt for the Program.115 Therefore, we believe it is recommendation of ‘Refine and ASCQR Program be endorsed by a appropriate to incorporate this measure Resubmit’ in 2016, we have completed national consensus building entity, or into the ASCQR Program measure set testing for this measure and continued by the NQF specifically. Further, under because collecting and publicly to refine this proposed measure in section 1833(i)(7)(B) of the Act, section reporting these data will improve response to the MAP’s 1833(t)(17)(C)(i) of the Act applies to the transparency, inform patients and recommendations. Results of continued ASCQR Program, except as the Secretary providers, and foster quality development activities, including may otherwise provide. Under this improvement efforts. stakeholder feedback from the public provision, the Secretary has further comment period and pilot test findings authority to adopt non-NQF-endorsed (3) Data Sources will be presented to the MAP during the measures. As stated in the CY 2012 This measure is claims-based and MAP feedback loop meeting in fall OPPS/ASC final rule with comment uses Part A and Part B Medicare 2017. The proposed measure is period (76 FR 74465 and 74505), we administrative claims and Medicare consistent with the information believe that consensus among affected enrollment data to calculate the submitted to the MAP, and the original parties can be reflected through means measure. MAP submission and our continued other than NQF endorsement, including We proposed that the data collection refinements support its scientific consensus achieved during the measure period for the proposed ASC–17: acceptability for use in quality reporting development process, consensus shown programs. Facility-level testing showed through broad acceptance and use of Hospital Visits after Orthopedic variation in unplanned hospital visits measures, and consensus through public Ambulatory Surgical Center Procedures among ASCs after adjusting for case-mix comment. We believe this proposed measure would be the two calendar differences, which suggests variation in measure meets these statutory years ending two years prior to the quality of care and opportunities for requirements. applicable payment determination year. quality improvement; and reliability The proposed ASC–17: Hospital Visits For example, for the CY 2022 payment testing showed fair measure score after Orthopedic Ambulatory Surgical determination, the data collection reliability.112 As expected, the Center Procedures measure is not period would be CY 2019 to 2020. currently NQF-endorsed. However, we Because the measure data are collected 109 National Quality Forum. List of Measures intend to submit this measure for review via claims, ASCs will not need to under Consideration for December 1, 2016. National and endorsement by NQF once an submit any additional data directly to Quality Forum, Dec. 2016. Available at: http:// CMS. We refer readers to section www.qualityforum.org/map/. 113 Yale New Haven Health Services XIV.D.4. of this final rule with comment 110 National Quality Forum. 2016–2017 Corporation—Center for Outcomes Research and period for a more detailed discussion of Spreadsheet of Final Recommendations to HHS and Evaluation (CORE). Measure Technical Report: CMS. Available at: https://www.qualityforum.org/ Hospital Visits after Orthopedic Ambulatory WorkArea/linkit.aspx?LinkIdentifier=id&ItemID= Surgical Center Procedures (Version 1.0). May 2017. 114 National Quality Forum. ‘‘MAP 2017 81593. Available at: https://www.cms.gov/Medicare/ Considerations for Implementing Measures in 111 Ibid. Quality-Initiatives-Patient-Assessment-Instruments/ Federal Programs: Hospitals.’’ Report. 2017. 112 Landis JR, Koch GG. The Measurement of HospitalQualityInits/Downloads/Version-10_ Available at: http://www.qualityforum.org/map/ Observer Agreement for Categorical Data. Hospital-Visits_Orthopedic-ASC-Procedures_ under ‘‘Hospitals—Final Report.’’ Biometrics. 1977;33(1):159–174. Measure-Technical-Report_052017.pdf. 115 Ibid.
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the requirements for data submitted via hospital visits; and (3) are routinely days after surgery. These patients are claims. performed by orthopedists. excluded to ensure all patients captured Procedures included in the measure under this measure have full data (4) Measure Calculation cohort are on Medicare’s list of covered available for outcome assessment. There The measure outcome is all-cause, ambulatory surgical center (ASC) are no additional inclusion or exclusion unplanned hospital visits within seven procedures.116 Medicare developed this criteria for the proposed ASC–17 days of an orthopedic procedure list to identify surgeries that have a low measure. Additional methodology and performed at an ASC. For the purposes to moderate risk profile. Surgeries on measure development details are of this measure, ‘‘hospital visits’’ the ASC list of covered procedures do available at: https://www.cms.gov/ include emergency department visits, not involve or require major or medicare/Quality-Initiatives-Patient- observation stays, and unplanned prolonged invasion of body cavities, Assessment-Instruments/ inpatient admissions. When there are extensive blood loss, major blood HospitalQualityInits/Measure- two or more qualifying surgical vessels, or care that is either emergent Methodology.html. procedures within a 7-day period, the or life threatening. Medicare annually measure considers all procedures as reviews and updates this list, and (6) Risk Adjustment index procedures; however, the includes a transparent public comment The statistical risk-adjustment model timeframe for outcome assessment is submission and review process for includes 29 clinically relevant risk- defined as the interval between addition and/or removal of procedures adjustment variables that are strongly procedures (including the day of the codes.117 The current list is accessible associated with risk of hospital visits next procedure) and then 7 days after in the Downloads section at: https:// within seven days following ASC the last procedure. www.cms.gov/medicare/medicare-fee- orthopedic surgery. The measure risk The facility-level score is a risk- for-service-payment/ascpayment/11_ adjusts for age, 27 comorbidities, and a standardized hospital visit rate, addenda_updates.html. variable for work Relative Value Units calculated by multiplying the ratio of In addition, to focus the measure only (RVUs) to adjust for surgical the predicted to the expected number of on the subset of surgeries on Medicare’s complexity.119 Additional risk post-surgical hospital visits among the list of covered ASC procedures that adjustment details are available in the given ASC’s patients by the national impose a meaningful risk of post- technical report at: https:// observed hospital visit rate for all ASCs. orthopedic ASC surgery hospital visits, www.cms.gov/medicare/Quality- For each ASC, the numerator of the ratio the measure includes only ‘‘major’’ and Initiatives-Patient-Assessment- is the number of hospital visits ‘‘minor’’ procedures, as indicated by the Instruments/HospitalQualityInits/ predicted for the ASC’s patients Medicare Physician Fee Schedule global Measure-Methodology.html. accounting for its observed rate, the surgery indicator (GSI) values of 090 (7) Public Reporting number of the orthopedic surgeries and 010, respectively. This list of GSI performed at the ASC, the case-mix, and values is publicly available at: https:// As stated above, facility-level testing the surgical complexity mix. The www.cms.gov/Medicare/Medicare-fee- showed variation in unplanned hospital denominator of the ratio is the expected for-service-payment/physicianfeesched/ visits among ASCs after adjusting for number of hospital visits given the pfs-federal-regulation-notices-items/ case-mix differences, which suggests ASC’s case-mix and surgical complexity cms-1590-fc.html (download variation in quality of care and mix. A ratio of less than one indicates Addendum B). Moreover, to identify the opportunities for quality the ASC facility’s patients were subset of ASC procedures typically improvement.120 Reliability testing estimated as having fewer post-surgical performed by orthopedists, we used the showed fair measure score reliability.121 visits than expected compared to ASCs Clinical Classifications Software (CCS) As expected, the reliability increased for with similar surgical complexity and developed by the Agency for Healthcare ASCs with more patients; ASCs with at patients; and a ratio of greater than one Research and Quality (AHRQ) and least 250 cases showed moderate indicates the ASC facility’s patients include in this measure procedures from reliability, consistent with other were estimated as having more visits AHRQ’s ‘‘operations on the publicly reported Medicare claims- than expected. The national observed musculoskeletal system’’ group of based, risk-adjusted outcome measures. hospital visit rate is the national procedures.118 For more cohort details, We proposed that if this measure were unadjusted proportion of patients who we refer readers to the measure adopted, we would publicly report had a hospital visit following an technical report located at: https:// results only for facilities with sufficient orthopedic ASC surgery. For more www.cms.gov/medicare/Quality- case numbers to meet moderate information on measure calculations, Initiatives-Patient-Assessment- reliability standards.122 CMS will we refer readers to: https:// Instruments/HospitalQualityInits/ determine the case size cutoff for www.cms.gov/medicare/Quality- Measure-Methodology.html. meeting moderate reliability standards Initiatives-Patient-Assessment- The measure excludes patients who using the intraclass correlation (ICC) Instruments/HospitalQualityInits/ survived at least 7 days following Measure-Methodology.html. orthopedic surgery at an ASC, but were 119 S. Coberly. The Basics; Relative Value Units not continuously enrolled in Medicare (RVUs). National Health Policy Forum. January 12, (5) Cohort 2015. Available at: http://www.nhpf.org/library/the- fee-for-service Parts A and B in the 7 basics/Basics_RVUs_01-12-15.pdf. The patient cohort for the proposed 120 Yale New Haven Health Services Corporation. ASC–17 measure includes all Medicare 116 Centers for Medicare and Medicaid Services. Hospital Visits after Orthopedic Ambulatory beneficiaries ages 65 and older ‘‘Ambulatory Surgical Center (ASC) Payment: Surgical Center Procedures (Version 1.0). May 2017. Addenda Updates.’’ Available at: https:// Available at: https://www.cms.gov/Medicare/ undergoing outpatient orthopedic www.cms.gov/medicare/medicare-fee-for-service- Quality-Initiatives-Patient-Assessment-Instruments/ surgery at an ASC who have 12 prior payment/ascpayment/11_addenda_updates.html. HospitalQualityInits/Downloads/Version-10_ months of Medicare fee-for-service Parts 117 Ibid. Hospital-Visits_Orthopedic-ASC-Procedures_ _ A and B enrollment. The target group of 118 Healthcare Cost and Utilization Project. Measure-Technical-Report 052017.pdf. 121 procedures includes those that: (1) Are Clinical Classifications Software for Services and Landis JR, Koch GG. The Measurement of Procedures. Available at: https://www.hcup- Observer Agreement for Categorical Data. routinely performed at ASCs; (2) involve us.ahrq.gov/toolssoftware/ccs_svcsproc/ Biometrics. 1977;33(1):159–174. some increased risk of post-surgery ccssvcproc.jsp. 122 Ibid.
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during the measure dry run (discussed measure so ASCs can use the suggested by the MAP. Several below) by testing the reliability of the information to identify performance commenters noted or were concerned scores at different case sizes in the dry gaps and develop quality improvement that the measure lacks NQF run data. However, we would also strategies. endorsement. A few commenters also provide confidential performance data These confidential dry run results are suggested that CMS seek input from the directly to smaller facilities, which do not publicly reported and do not affect MAP on the finalized measure prior to not meet the criteria for sufficient case payment. We expect the dry run to take including the measure in the program. numbers for reliability considerations approximately one month to conduct, Response: Section 1833(h)(7)(B) of the that would benefit from seeing their during which facilities would be Act does not require that each measure measure results and individual patient- provided the confidential report and the we adopt for the ASCQR Program be level outcomes. These data are currently opportunity to review their performance endorsed by a national consensus largely unknown to ASCs and providers. and provide feedback to us. However, building entity, or the NQF specifically. The validity testing results after the dry run, measure results would Under this provision, the Secretary has demonstrated that the measure scores have a payment impact and be publicly further authority to adopt non-endorsed are valid and useful measures of ASC reported beginning with the CY 2022 measures. As stated in the CY 2012 orthopedic surgical quality of care and payment determination and for OPPS/ASC final rule with comment will provide ASCs with information that subsequent years as proposed. Although period (76 FR 74465 and 74505), we can be used to improve their quality of not previously stated in the CY 2018 believe the requirement that measures care. Detailed testing results are OPPS/ASC proposed rule (82 FR 33694), reflect consensus among affected parties available in the technical report for this we note that the primary purpose of the can be achieved in other ways, measure, located at: https:// records maintained in the National including through the measure www.cms.gov/medicare/Quality- Claims History system of records (SOR) development process, broad acceptance Initiatives-Patient-Assessment- is for evaluating and studying the and use of the measure, and public Instruments/HospitalQualityInits/ operation and effectiveness of the comments. As part of the measure Measure-Methodology.html. Medicare program, which aligns with development process, a national the purposes of the ASCQR Program and Technical Expert Panel (TEP), clinical (8) Provision of Facility-Specific a permissible use of beneficiary Information Prior To Public Reporting experts, and stakeholders provided information. In addition, under 45 CFR input at multiple points during In the CY 2018 OPPS/ASC proposed 164.506(c)(4) of the HIPAA Privacy development. We believe the ASC–17 rule (82 FR 33694), we stated that if this Rule, we may disclose protected health measure meets these statutory proposed measure is finalized as information to another covered entity, requirements. proposed, we intend to conduct a dry such as the ASCs, provided that both We strive to adopt NQF-endorsed run before the official data collection the ASC and CMS have or had a measures when possible. Although period or any public reporting. A dry relationship with each individual who ASC–17 is not currently NQF-endorsed, run is a period of confidential reporting is the subject of the PHI being requested, our research and analysis conducted and feedback during which ASCs may the PHI pertains to such relationship, during development demonstrate that review their dry-run measure results, and the disclosure is for the purposes of the measure is accurate, valid, and and in addition, further familiarize conducting quality assessment and actionable. We refer readers to the themselves with the measure improvement activities listed in technical report for more information methodology and ask questions. For the paragraph (1) or (2) of the definition of about the measure and testing results: dry-run, we intend to use the most ‘‘health care operations’’ at 45 CFR https://www.cms.gov/Medicare/Quality- current 2-year set of complete claims 164.501. We believe that this provision Initiatives-Patient-Assessment- (usually 12 months prior to the start is extensive enough to cover the uses Instruments/HospitalQualityInits/ date) available at the time of dry run. that we would expect an ASC to make Downloads/Version-10_Hospital-Visits_ For example, if the dry run began in of the PHI. Orthopedic-ASC-Procedures_Measure- June 2018, the most current 2-year set of We invited public comment on our Technical-Report_052017.pdf. We will data available would likely be July 2015 proposal to adopt the ASC–17: Hospital submit this measure, with complete to June 2017. Because we use paid, final Visits after Orthopedic Ambulatory evidence, specifications, and testing action Medicare claims, ASCs would Surgical Center Procedures measure results, to NQF for endorsement when not need to submit any additional data beginning with the CY 2022 payment an appropriate NQF project has a call for the dry run. The dry run would determination as discussed above. for the measure. generate confidential feedback reports Comment: A few commenters In addition, in December 2016, the for ASCs, including patient-level data supported the proposed adoption of the MAP Hospital Workgroup reviewed and indicating whether the patient had a ASC–17: Hospital Visits after classified the measure as ‘‘Refine and hospital visit and, if so, the type of visit Orthopedic Ambulatory Surgical Center Resubmit Prior to Rulemaking.’’ 123 We (emergency department visit, Procedures in the ASCQR Program. One understand that the measure received observation stay, or unplanned inpatient of the commenters noted that these this classification because: (1) The admission), the admitting facility, and measures will provide patients with measure was still undergoing field the principal discharge diagnosis. valuable data and address clinical areas testing at the time, and (2) the MAP also Further, the dry run would enable ASCs critical to providers. to see their risk-standardized hospital Response: We thank the commenters recommended that the measure be visit rate prior to the measure being for their support. We agree that submitted to the NQF for review and implemented. General information measuring quality of care associated endorsement. Between that initial MAP about the dry run as well as confidential with orthopedic procedures performed review in December 2016 and the CY facility-specific reports would be made at ASCs is patient-centered and is an 2018 OPPS/ASC proposed rule, we available for ASCs to review on their important clinical care area to evaluate. 123 Spreadsheet of MAP 2017 Final accounts at: http://www.qualitynet.org. Comment: Two commenters believed Recommendations. February 1, 2017. Available at: We plan to continue to generate these that the measure should be refined and http://www.qualityforum.org/WorkArea/ reports for ASCs after we implement the resubmitted prior to rulemaking, as linkit.aspx?LinkIdentifier=id&ItemID=84452.
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completed field testing and refined the ultimately to minimize acute on CMS’ widely-used Planned measure.124 The final methodology complications and reduce unplanned Readmission Algorithm v4.0.128 We report, which was presented in the hospital visits following orthopedic refer readers to the measure proposed rule, included the final results procedures performed at ASCs. methodology report at: https:// of measure testing and completed The measure was purposely designed www.cms.gov/Medicare/Quality- measure specifications that occurred to evaluate all-cause hospital visits to Initiatives-Patient-Assessment- between the MAP’s review in December broadly capture serious adverse events Instruments/HospitalQualityInits/ 2016 and CMS’ proposal to adopt the experienced by patients after Measure-Methodology.html for more measure in the ASCQR Program.125 We undergoing orthopedic ASC procedures, details. also intend to update the MAP at the rather than a narrow set of identifiable Furthermore, we disagree with the next appropriate opportunity. As stated complications, for many reasons. The commenter’s suggestion that we remove above, we also intend to submit the outcome of all-cause hospital visits is ED visits and observation stays from the measure to the NQF for endorsement consistent with a patient-centric view of measure outcome, because these are during the next appropriate call for care that is designed to prompt ASC unplanned visits for patients measures. providers to minimize the risk and undergoing low- to moderate-risk Comment: A few commenters reduce the need for a broad range of outpatient procedures. From a patient expressed concerns over the measure outcomes after undergoing orthopedic perspective, we believe that ED visits outcome. One commenter stated that it ASC procedures, including the risk of and observation stays are an undesirable is not well proven that a hospital visit dehydration, nausea and vomiting, outcome. We believe a quality measure within 7 days of ASC procedure is a dizziness, and urinary retention. assessing hospital visits following ASC sign of poor quality. Similarly, one Measuring only hospital visits that are surgery will serve to improve commenter suggested that CMS should overtly related to a procedure, such as transparency, inform patients and adopt a measure that captures hospital visits for pain and bleeding, would limit providers, and foster quality visits directly tied to complications the measure’s intended broad impact on improvement, because providers at arising from orthopedic procedures quality improvement efforts. ASCs are often unaware of patients’ performed in an ASC, and another Furthermore, the rate of hospital visits subsequent acute care visits given that commenter suggested that CMS exclude is not expected to be zero, since some patients tend to present to the unrelated hospital visits. A commenter patients will have visits for reasons emergency department or to hospitals suggested that CMS remove ED visits unrelated to the procedure. In designing unaffiliated with the ASC. Moreover, and observation stays from the measure the measure, we narrowed the measure the measure outcome of hospital visits outcome because the ED is seen not as to include surgical procedure that: (1) within 7 days after a procedure aligns a healthcare resource to be avoided, but Are routinely performed at ASCs; (2) with the NQF-endorsed measure a key stabilization and decision point involve increased risk of post-surgery Facility 7-Day Risk-Standardized for patient disposition. Another hospital visits; and (3) are routinely Hospital Visit Rate after Outpatient commenter expressed concern about the performed by orthopedists. In addition, Colonoscopy Measure (NQF #2539). attribution of outcomes. Specifically, the measure is risk adjusted for patient Regarding the commenter’s concerns the commenter flagged four of the top demographics, clinical characteristics, about the attribution of outcomes and reasons for hospital visits within 7 days and surgical procedural complexity, so whether hospital visits within 7 days of of orthopedic procedures that likely that facilities that experience more ASC procedure is a sign of poor quality, reflect routine follow-up rather than unrelated visits due to a generally we believe that the measure captures the quality of care as intended by the higher-risk patient mix will not be full range of potentially serious adverse measure. disadvantaged. We refer readers to the events related to orthopedic procedures Response: We have designed the methods section in the measure performed as ASCs. We limited the measure to capture all unplanned specifications for more information outcome timeframe for hospital visits hospital visits that may be a signal of about the risk-adjustment methodology. (ED visits, observation stays, and poor quality of care and encourage ASCs In addition, we only measure the rate unplanned admissions) to 7 days to minimize the risk of follow-up of unplanned hospital admissions; ED because existing literature suggests that hospital visits. The outcome captures visits and observation stays are never the vast majority of adverse events after the full range of adverse events related considered planned.126 127 This an orthopedic procedure occur within to undergoing orthopedic ASC surgery. approach removes from the outcome the first 7 days following the procedure We believe that the measure, as admissions that are not a signal of and because the highest rates of hospital specified, has the potential to illuminate quality of care, because they represent: visits were observed in claims data differences in quality, inform patient within 7 days following the (1) A condition or diagnosis that is 129 130 choice, drive quality improvement, considered to be always planned (such procedure. A 7-day timeframe enhance care coordination, and as transplants or maintenance helps to ensure that the measure will capture adverse events following the 124 chemotherapy); or (2) that are MAP 2017 Considerations for Implementing considered potentially planned (such as procedure, but will not capture events Measures in Federal Programs: Hospitals. Final impacted by factors unrelated to the Report. February 15, 2017. Available at: http:// cardiovascular procedures) and are not www.qualityforum.org/Publications/2017/02/2017_ accompanied by an acute diagnosis. The _ _ _ _ _ 128 Ibid. Considerations for Implementing Measures Final planned admission algorithm is based Report_-_Hospitals.aspx. 129 Mattila K, Toivonen J, Janhunen L, Rosenberg 125 Yale New Haven Health Services PH, Hynynen M. Postdischarge symptoms after Corporation—Center for Outcomes Research and 126 Horwitz, Leora I., et al. ‘‘Development and ambulatory surgery: First-week incidence, intensity, Evaluation (CORE). Measure Technical Report: validation of an algorithm to identify planned and risk factors. Anesthesia and Analgesia. Hospital Visits after Orthopedic Ambulatory readmissions from claims data.’’ Journal of hospital 2005;101(6):1643–1650. Surgical Center Procedures (Version 1.0). May 2017. medicine 10.10 (2015): 670–677. 130 Fleisher LA, Pasternak LR, Herbert R, Available at: https://www.cms.gov/Medicare/ 127 Ranasinghe, Isuru, et al. ‘‘Differences in Anderson GF. Inpatient hospital admission and Quality-Initiatives-Patient-Assessment-Instruments/ colonoscopy quality among facilities: development death after outpatient surgery in elderly patients: HospitalQualityInits/Downloads/Version-10_ of a post-colonoscopy risk-standardized rate of Importance of patient and system characteristics Hospital-Visits_Orthopedic-ASC-Procedures_ unplanned hospital visits.’’ Gastroenterology 150.1 and location of care. Archives of Surgery. Measure-Technical-Report_052017.pdf. (2016): 103–113. 2004;139(1):67–72.
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care patients received.131 We appreciate usefulness of the measure to make number of ASCs and patients, in the commenter’s careful review of the distinction among facilities and to addition to actionable information to top hospital visit diagnoses within consumers, because the performance for lower the rate of preventable adverse seven days of orthopedic procedures. the overwhelming majority of the events and to improve the quality of We welcome specific examples of facilities would be no different than care following procedures performed at potentially planned admissions expected. an ASC. following outpatient orthopedic Response: We acknowledge the Although the majority of ASCs would procedures. commenters’ concerns regarding the use be expected to have risk-standardized Comment: One commenter suggested of claims data for the ASC–17 measure; rates that would be classified as ‘‘no that CMS provide a detailed clinical however, the measure would provide different than the national rate’’ on review of all the measure results by facilities with the most recently Hospital Compare, we believe that the several seasoned orthopedic surgeons to available, patient-level data to help measure will be able to make distinction ensure the measure algorithm is guide quality improvement efforts that among facilities and to consumers appropriate. would also be low burden. because the variation in risk- Response: In developing the measure, Further, we believe that measures of standardized hospital visit rates across we incorporated significant input from hospital events following specific types ASCs nationally suggests that there is various experts and stakeholders. In of surgical procedures fully based on still room for quality improvement. addition to the MUC and MAP Medicare FFS claims recently adopted Hospital Compare will also report processes described above, a (for example, ASC–12: Facility 7-Day facilities’ risk-standardized rates, and multidisciplinary team of clinicians, Risk Standardized Hospital Visit Rate facilities will receive confidential health services researchers, and after Outpatient Colonoscopy Measure) feedback reports to support quality statisticians were informed, in part, by and including those newly finalized in improvement efforts. Furthermore, a national TEP consisting of patients, this final rule with comment period feedback from national TEP members methodologists, researchers, and (that is, ASC–17: Hospital Visits after showed that the ASC–17 measure, as providers, including orthopedists who Orthopedic Ambulatory Surgical Center specified, can be used to distinguish conducted a detailed clinical review of Procedures and ASC–18: Hospital Visits between better and worse quality 134 all the measure results to ensure the after Urology Ambulatory Surgical facilities. This shows TEP agreement measure algorithm is appropriate. We Center Procedures) will better inform with the overall face validity of the also held a public comment period Medicare beneficiaries and other measure. soliciting stakeholder input on the consumers about post-procedure Comment: A few commenters measure methodology, including the complication rates. Existing ASC quality expressed concerns about risk planned admission algorithm. However, measures tend to focus on very rare, adjustment. A commenter noted that the measure is not risk adjusted to account we will continue to evaluate the patient safety-related events. For for socioeconomic status and other measure as our goal is to ensure that the example, ASC–3 counts cases in which factors beyond an ASC’s control. measure accurately reflects the quality a wrong site, wrong side, wrong patient, Another commenter noted that of care provided in ASCs. wrong procedure, or wrong implant We appreciate the commenter’s successful application of risk event occurred (76 FR 74499).132 careful review of the top hospital visit stratification methods must be Measures designed to capture more diagnoses within seven days of accomplished before using claims data, common adverse outcomes that patients orthopedic procedures. We welcome especially with the move from experience, such as pain, bleeding, specific examples of potentially planned traditionally inpatient procedures to the urinary retention, and other admissions following outpatient outpatient and ambulatory settings. A complications, prompting acute care orthopedic procedures. third commenter expressed a concern Comment: Some commenters were hospital visits or admissions are lacking about including condition category (CC concerned that ASCs may not have at this time, and this is what this 82), Respirator dependence/ actionable information generated from measure is intended to accomplish. tracheostomy status, on the list of ASC–17. Specifically, some commenters While we appreciate the commenter’s condition categories that are not risk- did not support adoption of the feedback that some ASCs were already adjusted if the condition occurs only at measure, because measure score aware of most of the visits in the claims the time of the procedure. The calculation relies on retrospective detail report and did not review the commenter noted that this type of claims data. The commenters expressed reports unless the facilities were condition is not something that concerns that the delay in providing categorized as underperforming, that is develops acutely within the timeframe data to facilities would provide limited not always the case. Providers at ASCs of an ASC procedure, but rather is usefulness for quality improvement or are often unaware of patients’ reflective of a more chronic patient for consumers in choosing an ASC subsequent acute care visits given that condition. facility. Regarding a similar measure, separate providers (for example, Response: We understand the ASC–12 Facility Risk-Standardized Visit emergency department physicians) tend important role that factors outside of an to provide post-surgical care when it is ASC’s control, for example, Rate after Outpatient Colonoscopy, one 133 commenter noted that in their members’ required. This measure is intended to socioeconomic and sociodemographic experience with the confidential bring greater awareness to a larger status, play in the care of patients. feedback reports, facilities were already 132 Centers for Medicare & Medicaid Services. aware of most of the visits in the claims 134 Yale New Haven Health Services Ambulatory Surgical Center Quality Reporting Corporation—Center for Outcomes Research and detail report and did not review the Specifications Manual Release Notes Version: 6.0. Evaluation (CORE). Measure Technical Report: reports unless the facilities were 2016; http://qualitynet.org/dcs/ContentServer?c= Hospital Visits after Orthopedic Ambulatory categorized as underperforming. The Page&pagename=QnetPublic%2FPage%2 Surgical Center Procedures (Version 1.0). May 2017. FQnetTier2&cid=1228772475754. Accessed July 13, Available at: https://www.cms.gov/Medicare/ commenter also questioned the 2016. Quality-Initiatives-Patient-Assessment-Instruments/ 133 Mezei G, Chung F. Return hospital visits and HospitalQualityInits/Downloads/Version-10_ 131 Parry, Nicola. ‘‘7-Day Readmissions: Better hospital readmissions after ambulatory surgery. Hospital-Visits_Orthopedic-ASC-Procedures_ Indicators of Patient Care.’’ Medscape, 2016. Annals of Surgery. 1999;230(5):721–727. Measure-Technical-Report_052017.pdf.
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Although the risk-adjustment categories are used to classify diagnoses incentivizing hospital services over methodology does not stratify by social into clinically coherent groups.137 We ASCs. Another commenter noted that risk factors, it does account for risk by consolidated like risk factors into ASCs still receive a full payment update adjusting for risk factors associated with candidate variables, which were the even if the ASCs are not involved in the increased risk for hospital visits after variables that we considered for the measure. surgery. In developing this measure, we risk-adjustment model. We agree with Response: We thank the commenters evaluated the potential effects of risk the commenter for noting that CC 82 is for their suggestions regarding the link adjusting for three socioeconomic status unlikely to develop acutely during the of the ASC–17 measure to payment. We (SES) factors that are available in CMS timeframe of a procedure; we will do not believe that the measure risks claims (Medicaid dual-eligibility status, review this group of codes and will incentivizing hospital services over African-American race, and the AHRQ consider revising the list of CCs that are ASCs. The ASCQR Program is a pay-for- SES index). Our results show that not risk-adjusted for if the condition reporting quality data program. This adjusting for these three factors at the occurs at the time of the procedure. As means that payments under our pay-for- patient level do not change the measure explained above, this measure was reporting quality data program are tied scores. We assessed the relationship of reviewed using a consensus-driven to reporting of the measures in the form SES to hospital visits at the patient and approach, with input from a national and manner specified, not to specific facility levels. Unadjusted and adjusted TEP and surgeons, including performance on the measures, like for ASC-level risk-standardized hospital orthopedists, providing care in the ASC pay-for-performance programs (for visit rates were highly correlated setting. Potential candidate risk factors example, the Hospital VBP Program (82 (Spearman correlation coefficients of and condition categories were identified FR 38240)). In addition, we believe that nearly 1.0) when calculated with and from related quality measures and the the measure does indeed reflect quality. without the addition of the three SES literature; 138 139 a preliminary list of risk Feedback from national TEP members variables (Medicaid dual-eligibility factors was developed and then revised showed that the ASC–17 measure, as status, African-American race, and the based on national TEP and clinical specified, can be used to distinguish AHRQ SES index). This indicates that expert review that included several between better and worse quality including SES variables in the ASC- orthopedists. These risk variables were facilities.141 This shows TEP agreement level risk-adjusted measure score will further released and reviewed during with the overall face validity of the result in limited differences in measure the measure development public measure. results after accounting for other risk comment period prior to the selection of We note that while ASCs will not be factors, such as age and comorbidities. the final model.140 This consensus- required to submit additional data for We refer readers to the methodology in based approach was used to achieve measure calculation, because this is a the measure specifications for more clinical face validity prior to the model claims-based measure, we strongly information about SES testing for this selection. encourage ASCs to review measure measure at: https://www.cms.gov/ Comment: One commenter suggested scores to improve quality of care and Medicare/Quality-Initiatives-Patient- that the ASC–17 should not be tied to patient outcomes. The detailed feedback Assessment-Instruments/ payment or measure procedures until reports, which provide information on HospitalQualityInits/Measure- after the first year of provision in the every procedure performed during the Methodology.html. We also refer readers ASC setting and noted concern that performance period and the details of to section XIV.B.2. of this final rule with doing so at the outset would not the hospital visits within seven days of comment period where we discuss accurately reflect quality and risks the orthopedic procedure, will enable social risk factors in the ASCQR ASCs to understand the post-surgical Program in more detail. Evaluation (CORE). Measure Technical Report: hospital visit patterns. We believe this In addition, analyses of ASCs Hospital Visits after Orthopedic Ambulatory will help to facilitate ASCs to tailor Surgical Center Procedures (Version 1.0). May 2017. clinical and educational interventions categorized into quartiles based on Available at: https://www.cms.gov/Medicare/ proportions of Medicaid dual-eligible Quality-Initiatives-Patient-Assessment-Instruments/ with the goal of reducing or eliminating patients, of African-American patients, HospitalQualityInits/Downloads/Version-10_ the risk of hospital visits for Hospital-Visits_Orthopedic-ASC-Procedures_ complication of an orthopedic surgery. and of low-SES patients (as identified _ by the AHRQ SES index),135 showed Measure-Technical-Report 052017.pdf. We also believe that the measure will 137 HCUP CCS Fact Sheet. Healthcare Cost and largely overlapping distributions (with Utilization Project (HCUP). January 2012. Agency facilitate improvements via public similar median values) of the risk- for Healthcare Research and Quality, Rockville, MD. reporting by informing the general standardized hospital visit rates https://www.hcup-us.ahrq.gov/toolssoftware/ccs/ public and ASCs even if particular ASCs (RSHVRs) by quartile. This means that ccsfactsheet.jsp. are not active in the measure. 138 Sherman SL, Lyman S, Koulouvaris P, Willis Comment: A few commenters facilities serving larger proportions of A, Marx RG. Risk factors for readmission and low-SES patients perform similarly to revision surgery following rotator cuff repair. expressed concerns about the reliability facilities serving lower proportions of Clinical Orthopaedics and Related Research. of the measure. One commenter noted low-SES patients. 2008;466(3):608–613. that low-volume situations tend to Furthermore, we appreciate the 139 Fleisher LA, Pasternak LR, Herbert R, produce measure scores that lack Anderson GF. Inpatient hospital admission and reliability. The commenter noted that commenter’s concern about including death after outpatient surgery in elderly patients: condition category (CC) 82 on the list of Importance of patient and system characteristics the measure is only ‘‘fairly’’ reliable and condition categories that are not risk- and location of care. Archives of Surgery. suggested the reliability for a measure adjusted for if they occur only at the 2004;139(1):67–72. intended for public reporting should be 140 136 Yale New Haven Health Services substantially reliable, or have an ICC of time of the procedure. Condition Corporation—Center for Outcomes Research and Evaluation (CORE). Measure Technical Report: 0.61 to 0.80. Furthermore, the 135 Bonito A, Bann C, Eicheldinger C, Carpenter Hospital Visits after Orthopedic Ambulatory commenter noted that the measure also L. Creation of new race-ethnicity codes and Surgical Center Procedures (Version 1.0). May 2017. suffers from limited discriminatory socioeconomic status (SES) indicators for Medicare Available at: https://www.cms.gov/Medicare/ power because the number of beneficiaries. RTI International, Agency for Quality-Initiatives-Patient-Assessment-Instruments/ Healthcare Research and Quality. 2008. HospitalQualityInits/Downloads/Version-10_ underperforming facilities is very small. 136 Yale New Haven Health Services Hospital-Visits_Orthopedic-ASC-Procedures_ Corporation—Center for Outcomes Research and Measure-Technical-Report_052017.pdf. 141 Ibid.
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The commenter urged CMS to ensure increased reliability with increased case comment period for more details about that the publicly reported scores are numbers.148 Specifically, for ASCs with public reporting of this measure. We reliable. A few commenters expressed at least 250 cases in each of the two expect that smaller ASCs will still concern about the reliability of the samples, the ICC was 0.359, which benefit from confidentially reviewing measure for public reporting. reflects better reliability that is more their measure results and individual Response: We thank the commenters consistent with previously developed patient-level outcomes in the facility- for their feedback about the measure measures.149 During the measure dry specific report, as these data are reliability. We disagree with the run, we intend to determine the case currently largely unknown to ASCs and commenters and believe that ASC–17 is size cutoff for meeting moderate providers. sufficiently reliable to be included in reliability standards using the ICC by Comment: One commenter requested the ASCQR Program. Our calculated testing the reliability of the scores at that the dry run results be aggregated intraclass correlation coefficient different case sizes in the dry run data. and made available in its entirety to the (ICC),142 a measure of reliability or the In the 4-year data set, of the 3,075 ASCs, public for review and comment if the degree to which the measure can 467 (15.2 percent) had 250 or more measure is finalized. The commenter produce accurate and consistent results procedures, accounting for 57.3 percent also suggested that CMS conduct pilot across multiple measurements of the of all procedures in the measure testing for the measure with volunteer same entities in a time period, for this cohort.150 ASCs rather than conduct national dry measure was 0.226.143 The NQF Regarding the comment about lack of runs. considers ICC values ranging from 0.01– discriminatory power, we agree that the Response: We refer readers to section 0.20 as ‘‘slight’’ reliability, 0.21–0.40 as many small-volume ASCs will limit the XIV.B.6.b.(7) of this final rule with ‘‘fair’’ reliability, 0.41 to 0.60 as ability to make distinctions in comment period where we discuss our ‘‘moderate’’ reliability, and 0.61 to 0.80 performance between facilities. ASCs dry run. The intent of the dry run is to as ‘‘strong’’ reliability.144 Although this with few cases in a given year limit our test production of the measure and for value indicates fair measure score ability to capture variation in ASC-level ASCs to familiarize themselves with the reliability,145 we recognize that it is measure scores because our modeling measure and provide feedback to us. lower than for other claims-based methodology is conservative and will The dry run will generate confidential outcomes measures developed by estimate measure scores toward the feedback reports for ASCs on measure CMS.146 However, as we would expect, national mean for facilities with small performance and risk-standardized the ICC increases for ASCs with more volumes. Specifically, ASCs with hospital visit rates, among other data. patients.147 We disagree that the relatively few cases in the performance We plan to perform a dry run of the measure reliability should be period may have a true rate that is measure prior to implementation. The ‘‘substantially’’ reliable, or have an ICC worse/better than the national average. confidential dry run results will not be of 0.61 to 0.80, and believe the publicly However, the model estimates their rate publicly reported or used for payment reported scores will be sufficiently as close to the mean because their low determination. We believe a dry run reliable based on results showing volume does not provide enough will be more beneficial than pilot information to accurately estimate a testing. The dry run will include all 142 Landis J, Koch G. The measurement of value near their true rate. As a result, ASCs rather than just a subset of observer agreement for categorical data, Biometrics the model may capture less variation volunteer ASCs and will enable all 1977;33:159–174. than truly exists due to low case sizes. ASCs to gain familiarity with the 143 Yale New Haven Health Services Corporation—Center for Outcomes Research and To improve the measure’s ability to measure and processes, as well as Evaluation (CORE). Measure Technical Report: detect quality differences, we crafted provide feedback to CMS on both the Hospital Visits after Orthopedic Ambulatory our proposal to use 2 years of data for measure itself and the reports. This will Surgical Center Procedures (Version 1.0). May 2017. public reporting to expand the number also enable CMS to learn about any Available at: https://www.cms.gov/Medicare/ Quality-Initiatives-Patient-Assessment-Instruments/ of cases available for estimating rates unanticipated nuances associated with HospitalQualityInits/Downloads/Version-10_ across all facilities and to increase both measure implementation. Hospital-Visits_Orthopedic-ASC-Procedures_ the reliability of the measure score and As proposed, we will not publicly Measure-Technical-Report_052017.pdf. the ability to discriminate performance report data for this measure until the CY 144 Landis J, Koch G. The measurement of across facilities. Furthermore, ASC 2022 payment determination and observer agreement for categorical data, Biometrics 1977;33:159–174. facilities that have too few cases to subsequent years. We do not believe 145 The NQF considers ICC values ranging from reliably estimate a measure score publicly reporting data from the dry run 0.01–0.20 as ‘‘slight’’ reliability, 0.21–0.40 as ‘‘fair’’ (moderate reliability as discussed in the is appropriate as we might still be reliability, 0.41 to 0.60 as ‘‘moderate’’ reliability, prior paragraph) would be treated in the working out unanticipated nuances; the and 0.61 to 0.80 as ‘‘strong’’ reliability. http:// data is preliminary and is therefore www.qualityforum.org/Measuring_Performance/ same way as other facilities with too few Improving_NQF_Process/Measure_Testing_Task_ cases and would not have their scores subject to change based on feedback Force_Final_Report.aspx. posted on Hospital Compare; their data provided by ASCs. 146 See the Risk-Standardized Hospital Visits would be replaced with a footnote. We Comment: A commenter noted that within 7 Days After Hospital Outpatient Surgery discuss our Hospital Compare footnotes although CMS believes that there would Measure. For ICC score of 0.50: https:// not be any additional burden because www.cms.gov/Medicare/Quality-Initiatives-Patient- at: https://www.medicare.gov/ Assessment-Instruments/HospitalQualityInits/ hospitalcompare/data/Footnotes.html. ASCs are not required to submit Downloads/Hospital-Visits-after-Hospital- However, these facilities will still additional data, reviewing claims detail Outpatient-Surgery-Measure.pdf. receive confidential feedback reports/ reports and measure scores would be 147 Yale New Haven Health Services associated with additional burden for Corporation—Center for Outcomes Research and facility-specific reports providing Evaluation (CORE). Measure Technical Report: valuable information about post-surgery someone at ASCs, likely a clinician. Hospital Visits after Orthopedic Ambulatory events. We refer readers to section Response: We thank the commenter Surgical Center Procedures (Version 1.0). May 2017. XIV.B.6.b.(7) of this final rule with for providing this input and Available at: https://www.cms.gov/Medicare/ acknowledge that this measure will be Quality-Initiatives-Patient-Assessment-Instruments/ HospitalQualityInits/Downloads/Version-10_ 148 Ibid. calculated completely from data already Hospital-Visits_Orthopedic-ASC-Procedures_ 149 Ibid. obtained from paid Medicare FFS Measure-Technical-Report_052017.pdf. 150 Ibid. claims submitted by ASCs, hospitals,
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and physicians for billing purposes. to other procedures,154 we believe must make available to the public by Because claims data are used, there is measuring and reporting 7-day December 1 of each year a list of quality no burden on the part of ASCs to submit unplanned hospital visits following and efficiency measures that the additional data for measure calculation. urology procedures will incentivize Secretary is considering for the We strongly suggest that facilities ASCs to improve care and care Medicare program. The ASC–18: allocate time to review their feedback transitions. Many of the reasons for Hospital Visits after Urology report, because they contain actionable hospital visits following surgery at an Ambulatory Surgical Center Procedures information to identify performance ASC are preventable; patients often measure was included on a publicly gaps and further develop quality present to the hospital following available document entitled ‘‘List of improvement strategies. However, we urology surgery for complications of Measures under Consideration for note that these activities do not medical care, including urinary tract December 1, 2016.’’ 157 The MAP represent burden related to program infection, calculus of the ureter, urinary reviewed this measure (MUC16–153) requirements. retention, hematuria, and septicemia.155 and recommended that this measure be After consideration of the public However, increased patient and staff refined and resubmitted prior to comments we received, we are education present opportunities to adoption by the ASCQR Program improve the success rate of urology because, at the time of the MAP’s finalizing the proposal to adopt the 156 ASC–17: Hospital Visits after surgeries in ASCs. Therefore, we review, this measure was still Orthopedic Ambulatory Surgical Center believe tracking and reporting these undergoing field testing. The Procedures measure in the ASCQR events would facilitate efforts to lower Workgroup stated testing results should the rate of preventable adverse events demonstrate reliability and validity at Program for the CY 2022 payment and to improve the quality of care the facility level in the ambulatory determination and subsequent years, as following urology procedures performed surgical setting, and recommended this proposed. at an ASC. measure be submitted to NQF for review c. Adoption of ASC–18: Hospital Visits and endorsement.158 (2) Overview of Measure After Urology Ambulatory Surgical Since the MAP’s review and Center Procedures Beginning With the We believe it is important to recommendation of ‘Refine and CY 2022 Payment Determination minimize adverse patient outcomes Resubmit’ in 2016, we have completed associated with urology ASC surgeries. testing for this measure and continued (1) Background Therefore, in the CY 2018 OPPS/ASC to refine this proposed measure in As the number of urology procedures proposed rule (82 FR 33695), we response to the MAP’s performed in ASCs increases, it is of proposed to adopt the ASC–18: Hospital recommendations. Results of continued increasing importance to report the Visits after Urology Ambulatory development activities, including quality of care provided to patients Surgical Center Procedures measure in stakeholder feedback from the public undergoing these procedures. One study the ASCQR Program for the CY 2022 comment period and pilot test findings found that urology procedures payment determination and subsequent will be presented to the MAP during the accounted for 4.8 percent of years. We expect the measure would MAP feedback loop meeting in fall unanticipated admissions, and that promote improvement in patient care 2017. The proposed measure is urology surgery patients were almost over time, because measurement consistent with the information twice as likely as orthopedics, plastic coupled with transparency in publicly submitted to the MAP, and the original surgery, or neurosurgery to be admitted reporting measure information would MAP submission and our continued following surgery.151 Similarly, a recent make the rate of unplanned hospital refinements support its scientific study found outpatient urology surgery visits (emergency department visits, acceptability for use in quality reporting has an overall 3.7 percent readmission observation stays, and unplanned programs. Facility-level testing showed rate.152 A third study using a 5-percent inpatient admissions) following urology significant variation in unplanned national sample of Medicare procedures at ASCs more visible to both hospital visits among ASCs after beneficiaries ages 65 and older who ASCs and patients, and would adjusting for case-mix differences, underwent one of 22 common incentivize ASCs to incorporate quality which suggests variation in quality of outpatient urologic procedures at ASCs improvement activities to reduce these care. Our testing found moderate 159 from 1998 to 2006 found a 7.9 percent unplanned hospital visits. The measure measure score reliability for this 30-day risk-adjusted rate of inpatient also addresses the CMS National measure, which is consistent with admission following surgery, with more Quality Strategy domains of making care existing measures of patient outcomes frequent same-day admissions following safer by reducing harm caused in the in the ASC setting, such as ASC–12: outpatient surgery at ASCs than at delivery of care and promoting effective Facility Seven-Day Risk-Standardized hospitals.153 communication and coordination of Hospital Visit Rate after Outpatient care. Colonoscopy (described in the CY 2015 Because urology surgery performed at Section 1890A of the Act requires the OPPS/ASC final rule with comment an ASC is a significant predictive factor Secretary to establish a prerulemaking period at 79 FR 66973). Validity testing for unanticipated admissions compared process with respect to the selection of demonstrated that the measure scores certain categories of quality and 151 Fortier J. Unanticipated Admission after efficiency measures. Under section 157 National Quality Forum. List of Measures Ambulatory Surgery—A Prospective Study. 1890A(a)(2) of the Act, the Secretary under Consideration for December 1, 2016. National Canadian Journal of Anaesthesia. 1998;45(7):612– Quality Forum, Dec. 2016. Available at: http:// 619. www.qualityforum.org/map/. 152 Rambachan A. Predictors of Readmission 154 Fortier J. Unanticipated Admission after 158 National Quality Forum. 2016–2017 Following Outpatient Urological Surgery, Annals of Ambulatory Surgery—A Prospective Study. Spreadsheet of Final Recommendations to HHS and the Royal College of Surgeons of England. Journal Canadian Journal of Anaesthesia. 1998;45(7):612– CMS, available at: https://www.qualityforum.org/ of Urology. 2014;192(1):183–188. 619. WorkArea/ 153 Hollingsworth JM. Surgical Quality Among 155 Paez A. Adverse Events and Readmissions linkit.aspx?LinkIdentifier=id&ItemID=81593. Medicare Beneficiaries Undergoing Outpatient after Day-Care Urological Surgery. International 159 Landis JR, Koch GG. The Measurement of Urological Surgery. The Journal of Urology. Brazilian Journal of Urology. 2007;33(3):330–338. Observer Agreement for Categorical Data. 2012;188(4):1274–1278. 156 Ibid. Biometrics. 1977;33(1):159–174.
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identify differences in quality across development public comment period.160 two or more qualifying surgical facilities. Detailed testing results are During the MAP and measure procedures within a 7-day period, the available in the technical report for this development processes, public measure considers all procedures as measure, located at: https:// commenters supported the measure’s index procedures. However, the www.cms.gov/medicare/Quality- focus on assessing patient outcomes timeframe for outcome assessment is Initiatives-Patient-Assessment- after urology ASC and agreed that the defined as the interval between Instruments/HospitalQualityInits/ measure would be meaningful and procedures (including the day of the Measure-Methodology.html. improve quality of care. In addition, the next procedure) and then 7 days after Sections 1833(i)(7)(B) and ASC–18: Hospital Visits after Urology the last procedure. 1833(t)(17)(C)(i) of the Act, when read Ambulatory Surgical Center Procedures The facility-level score is a risk- together, require the Secretary, except as measure addresses the MAP-identified standardized hospital visit rate, the Secretary may otherwise provide, to priority measure area of surgical calculated by multiplying the ratio of develop measures appropriate for the complications for the ASCQR the predicted to the expected number of measurement of the quality of care Program.161 Therefore, we believe it is postsurgical hospital visits among the furnished by ASCs that reflect appropriate to incorporate this measure given ASC’s patients by the national consensus among affected parties and, into the ASCQR Program measure set observed hospital visit rate for all ASCs. to the extent feasible and practicable, because collecting and publicly For each ASC, the numerator of the ratio that include measures set forth by one reporting this data will improve is the number of hospital visits or more national consensus building transparency, inform patients and predicted for the ASC’s patients entities. However, we note that section providers, and foster quality accounting for its observed rate, the 1833(i)(7)(B) of the Act does not require improvement efforts. number of the urology procedures that each measure we adopt for the performed at the ASCs, the case-mix, (3) Data Sources ASCQR Program be endorsed by a and the surgical complexity mix. The national consensus building entity, or This measure is claims-based and denominator of the ratio is the expected by the NQF specifically. Further, under uses Part A and Part B Medicare number of hospital visits given the section 1833(i)(7)(B) of the Act, section administrative claims and Medicare ASC’s case-mix and surgical complexity 1833(t)(17)(C)(i) of the Act applies to the enrollment data to calculate the mix. A ratio of less than one indicates ASCQR Program, except as the Secretary measure. the ASC facility’s patients were may otherwise provide. Under this We proposed that the data collection estimated as having fewer post-surgical provision, the Secretary has further period for the proposed ASC–18: visits than expected compared to ASCs authority to adopt non-endorsed Hospital Visits after Urology with similar surgical complexity and measures. As stated in the CY 2012 Ambulatory Surgical Center Procedures patients; and a ratio of greater than one OPPS/ASC final rule with comment measure would be the 2 calendar years indicates the ASC facility’s patients period (76 FR 74465 and 74505), we ending 2 years prior to the applicable were estimated as having more visits believe that consensus among affected payment determination year. For than expected. The national observed parties can be reflected through means example, for the CY 2022 payment hospital visit rate is the national other than NQF endorsement, including determination, the data collection unadjusted proportion of patients who consensus achieved during the measure period would be CY 2019 to 2020. had a hospital visit following a urology development process, consensus shown Because these measure data are ASC surgery. For more information on measure calculations, we refer readers through broad acceptance and use of collected via claims, ASCs will not need to: https://www.cms.gov/medicare/ measures, and consensus through public to submit any additional data directly to Quality-Initiatives-Patient-Assessment- comment. We believe this proposed CMS. We refer readers to section Instruments/HospitalQualityInits/ measure meets these statutory XIV.D.4. of this final rule with comment Measure-Methodology.html. requirements. period for a more detailed discussion of The proposed ASC–18: Hospital Visits the requirements for data submitted via (5) Cohort after Urology Ambulatory Surgical claims. The patient cohort for the proposed Center Procedures measure is not (4) Measure Calculations ASC–18: Hospital Visits after Urology currently NQF-endorsed. However, we Ambulatory Surgical Center Procedures The measure outcome is all-cause, intend to submit this measure for review measure includes all Medicare unplanned hospital visit occurring and endorsement by the NQF once an beneficiaries ages 65 and older appropriate measure endorsement within seven days of the urology undergoing outpatient urology project has a call for measures. We procedure performed at an ASC. For the procedures at an ASC who have 12 prior believe that this measure is appropriate purpose of this measure, ‘‘hospital months of Medicare fee-for-service Parts for the measurement of quality care visits’’ include emergency department A and B enrollment. The target group of furnished by ASCs because urology visits, observation stays, and unplanned procedures are those that: (1) Are procedures are becoming increasingly inpatient admissions. When there are routinely performed at ASCs; (2) involve common in ASCs and, as discussed increased risk of post-surgery hospital above, can signify unanticipated 160 Yale New Haven Health Services Corporation—Center for Outcomes Research and visits; and (3) are routinely performed admissions after care provided in ASCs. Evaluation (CORE). Public Comment Summary by urologists. Such visits are an unexpected and Report: Development of Facility-Level Quality Procedures included in the measure potentially preventable outcome for Measures of Unplanned Hospital Visits after cohort are on Medicare’s list of covered patients with a low anticipated Selected Ambulatory Surgical Center Procedures. ambulatory surgical center (ASC) Fall 2016. Available at: https://www.cms.gov/ 162 perioperative risk. We also believe this Medicare/Quality-Initiatives-Patient-Assessment- procedures. Medicare developed this measure depicts consensus among Instruments/MMS/CallforPublicComment.html. affected parties, as it was developed 161 National Quality Forum. ‘‘MAP 2017 162 Centers for Medicare and Medicaid Services. with stakeholder input from both a Considerations for Implementing Measures in ‘‘Ambulatory Surgical Center (ASC) Payment: Federal Programs: Hospitals.’’ Report. 2017. Addenda Updates.’’ Available at: https:// Technical Expert Panel convened by a Available at: http://www.qualityforum.org/map/ www.cms.gov/medicare/medicare-fee-for-service- contractor as well as the measure under ‘‘Hospitals—Final Report.’’ payment/ascpayment/11_addenda_updates.html.
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list to identify surgeries have a low to available at: https://www.cms.gov/ numbers for reliability considerations moderate risk profile. Surgeries on the medicare/Quality-Initiatives-Patient- that would benefit from seeing their ASC list of covered procedures do not Assessment-Instruments/ measure results and individual patient- involve or require major or prolonged HospitalQualityInits/Measure- level outcomes, as these data are invasion of body cavities, extensive Methodology.html. currently largely unknown to ASCs and blood loss, major blood vessels, or care providers. The validity testing results (6) Risk Adjustment that is either emergent or life demonstrated that the measure scores threatening.163 Medicare annually The statistical risk-adjustment model are valid and useful measures of ASC reviews and updates this list, and includes nine clinically relevant risk- urology surgical quality of care and will includes a transparent public comment adjustment variables that are strongly provide ASCs with information that can submission and review process for associated with risk of hospital visits be used to improve their quality of care. addition and/or removal of procedures within seven days following ASC Detailed testing results are available in codes.164 The current list is accessible urology surgery. The measure risk the technical report for this measure, in the Downloads section at: https:// adjusts for age, six comorbidities, located at: https://www.cms.gov/ www.cms.gov/medicare/medicare-fee- number of qualifying procedures, and medicare/Quality-Initiatives-Patient- for-service-payment/ascpayment/11_ work Relative Value Units (RVUs) to Assessment-Instruments/ addenda_updates.html. In addition, to adjust for surgical complexity.166 HospitalQualityInits/Measure- focus the measure only on the subset of Additional risk adjustment details are Methodology.html. surgeries on Medicare’s list of covered available in the technical report at: (8) Provision of Facility-Specific ASC procedures that impose a https://www.cms.gov/medicare/Quality- Information Prior to Public Reporting meaningful risk of post-urology ASC Initiatives-Patient-Assessment- surgery hospital visits, the measure Instruments/HospitalQualityInits/ In the CY 2018 OPPS/ASC proposed includes only ‘‘major’’ and ‘‘minor’’ Measure-Methodology.html. rule (82 FR 33694), we noted that if this proposed measure is finalized, but procedures, as indicated by the MPFS (7) Public Reporting global surgery indicator (GSI) values of before the official data collection period 090 and 010, respectively, and As stated above, facility-level testing or public reporting for the proposed therapeutic cystoscopy procedures. This showed variation in unplanned hospital ASC–18 measure, we intend to conduct list of GSI values is publicly available visits among ASCs after adjusting for a dry run. A dry run is a period of at: https://www.cms.gov/Medicare/ case-mix differences, which suggests confidential feedback during which Medicare-fee-for-service-payment/ variation in quality of care and ASCs may review their dry-run measure physicianfeesched/pfs-federal- opportunities for quality results, and in addition, further 167 regulation-notices-items/cms-1590- improvement. Reliability testing familiarize themselves with the measure 168 fc.html (download Addendum B). showed fair measure score reliability. methodology, and ask questions. For the Moreover, to identify the subset of ASC As expected, the reliability increased for dry-run, we intend to use the most procedures typically performed by ASCs with more patients; ASCs with at current 2-year set of complete claims urologists, we used the Clinical least 250 cases showed moderate (usually 12 months prior to the start Classifications Software (CCS) reliability, consistent with other date) available at the time of dry run. developed by the Agency for Healthcare publicly reported Medicare claims- For example, if the dry run began in Research and Quality (AHRQ) and based, risk-adjusted outcome measures. June 2018, the most current 2-year set of include in this measure procedures from In the CY 2018 OPPS/ASC proposed data available would likely be July 2015 two of AHRQ’s categories, ‘‘operations rule (82 FR 33694), we noted that if this to June 2017. Because we use paid, final on the urinary system’’ and ‘‘operations measure is adopted, we proposed to action Medicare claims, ASCs would on the male genital organs.’’ 165 For publicly report results only for facilities not need to submit any additional data more cohort details, we refer readers to with sufficient case numbers to meet for the dry run. The dry run would 169 the measure technical report located at: moderate reliability standards. CMS generate confidential feedback reports https://www.cms.gov/medicare/Quality- will determine the case size cutoff for for ASCs, including patient-level data Initiatives-Patient-Assessment- meeting moderate reliability standards indicating whether the patient had a Instruments/HospitalQualityInits/ using the intraclass correlation (ICC) hospital visit and, if so, the type of visit Measure-Methodology.html. during the measure dry run (discussed (emergency department visit, The measure excludes patients who below) by testing the reliability of the observation stay, or unplanned inpatient survived at least 7 days following a scores at different case sizes in the dry admission), the admitting facility, and urology procedure at an ASC, but were run data. However, we would also the principal discharge diagnosis. not continuously enrolled in Medicare provide confidential performance data Further, the dry run would enable ASCs fee-for-service Parts A and B in the 7 directly to smaller facilities which do to see their risk-standardized hospital days after surgery. These patients are not meet the criteria for sufficient case visit rate prior to the measure being excluded to ensure all patients captured implemented. General information under this measure have full data 166 S. Coberly. The Basics; Relative Value Units about the dry run as well as confidential (RVUs). National Health Policy Forum. January 12, available for outcome assessment. There 2015. Available at: http://www.nhpf.org/library/the- facility-specific reports would be made are no additional inclusion or exclusion basics/Basics_RVUs_01-12-15.pdf. available for ASCs to review on their criteria for the proposed ASC–18 167 Yale New Haven Health Services Corporation. accounts at: http://www.qualitynet.org. measure. Additional methodology and Hospital Visits after Orthopedic Ambulatory We intend to continue to generate these Surgical Center Procedures (Version 1.0). May 2017. measure development details are Available at: https://www.cms.gov/Medicare/ reports for ASCs after we implement the Quality-Initiatives-Patient-Assessment-Instruments/ measure so ASCs can use the 163 Ibid. HospitalQualityInits/Downloads/Version-10_ information to identify performance 164 Ibid. Hospital-Visits_Orthopedic-ASC-Procedures_ _ gaps and develop quality improvement 165 Healthcare Cost and Utilization Project. Measure-Technical-Report 052017.pdf. 168 strategies. Clinical Classifications Software for Services and Landis JR, Koch GG. The Measurement of The confidential dry run results are Procedures. Available at: https://www.hcup- Observer Agreement for Categorical Data. us.ahrq.gov/toolssoftware/ccs_svcsproc/ Biometrics. 1977;33(1):159–174. not publicly reported and do not affect ccssvcproc.jsp. 169 Ibid. payment. We expect the dry run to take
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approximately one month to conduct, Response: Section 1833(h)(7)(B) of the report, which was presented in the during which facilities would be Act does not require that each measure proposed rule, included the final results provided the confidential report and the we adopt for the ASCQR Program be of measure testing and completed opportunity to review their performance endorsed by a national consensus measure specifications that occurred and provide feedback to us. However, building entity, or the NQF specifically. between the MAP’s review in December after the dry run, measure results would Under this provision, the Secretary has 2016 and CMS’ proposal to adopt the have a payment impact and would be further authority to adopt non-endorsed measure in the ASCQR Program.172 We publicly reported beginning with the CY measures. As stated in the CY 2012 also intend to update the MAP at the 2022 payment determination and for OPPS/ASC final rule with comment next appropriate opportunity. As stated subsequent years as proposed. Although period (76 FR 74465 and 74505), we above, we also intend to submit the not previously stated in the CY 2018 believe the requirement that measures measure to the NQF for endorsement OPPS/ASC proposed rule (82 FR 33694), reflect consensus among affected parties during the next appropriate call for we note that the primary purpose of the can be achieved in other ways, measures. records maintained in the National including through the measure Comment: A commenter expressed Claims History system of records (SOR) development process, broad acceptance concern about the attribution of is for evaluating and studying the and use of the measure, and public outcomes. Specifically, the commenter operation and effectiveness of the comments. As part of the measure flagged eight of the top reasons for Medicare program, which aligns with development process, a national hospital visits within 7 days of urologic the purposes of the ASCQR Program and Technical Expert Panel (TEP), clinical procedures that likely reflect routine a permissible use of beneficiary experts, and stakeholders provided follow-up rather than quality of care as information. In addition, under 45 CFR input at multiple points during intended by the measure. Another 164.506(c)(4) of the HIPAA Privacy development. We believe the ASC–18 commenter suggested that CMS develop Rule, we may disclose protected health measure meets these statutory a numerator exclusion for unrelated information to another covered entity, requirements. hospital visits. such as the ASCs, provided that both We strive to adopt NQF-endorsed Response: We acknowledge that the the ASC and CMS have or had a measures when possible. Although rate of hospital visits is not expected to relationship with each individual who ASC–18 is not currently NQF-endorsed, be zero, since some patients will have is the subject of the PHI being requested, our research and analysis conducted visits for reasons unrelated to the the PHI pertains to such relationship, during development demonstrate that procedure. In designing the measure, we and the disclosure is for the purposes of the measure is accurate, valid, and narrowed the measure to include conducting quality assessment and actionable. We refer readers to the surgical procedures that: (1) Are improvement activities listed in technical report for more information routinely performed at ASCs; (2) involve paragraph (1) or (2) of the definition of about the measure and testing results: increased risk of post-surgery hospital ‘‘health care operations’’ at 45 CFR https://www.cms.gov/Medicare/Quality- visits; and (3) are routinely performed 164.501. We believe that this provision Initiatives-Patient-Assessment- by urologists. In addition, the measure is extensive enough to cover the uses Instruments/HospitalQualityInits/ is risk-adjusted for patient that we would expect an ASC to make Downloads/Version-10_Hospital-Visits_ demographics, clinical characteristics, of the PHI. Urology-ASC-Procedures_Measure- and surgical procedural complexity, so We invited public comment on our Technical-Report_052017.pdf. We will that facilities that experience more proposal to adopt the ASC–18: Hospital submit this measure, with complete unrelated visits due to a generally Visits after Urology Ambulatory evidence, specifications, and testing higher-risk patient mix will not be Surgical Center Procedures measure results, to NQF for endorsement when disadvantaged. We refer readers to the beginning with the CY 2022 payment an appropriate NQF project has a call methods section in the measure determination as discussed above. for the measure. specifications for more information Comment: A few commenters about the risk-adjustment methodology. supported the proposed adoption of the In addition, in December 2016, the MAP Hospital Workgroup reviewed and In addition, we only measure the rate ASC–18: Hospital Visits after Urology of unplanned hospital admissions; ED Ambulatory Surgical Center Procedures classified the measure as ‘‘Refine and Resubmit Prior to Rulemaking.’’ 170 We visits and observation stays are never measure in the ASCQR Program. One of 173 174 understand that the measure received considered planned. This the commenters noted that the measure approach removes from the outcome will provide patients with valuable data this classification because: (1) The measure was still undergoing field admissions that are not a signal of and address clinical areas critical to quality of care, because they represent: providers. testing at the time, and (2) the MAP also recommended that the measure be Response: We thank the commenters 172 Yale New Haven Health Services for their support. We agree that submitted to the NQF for review and Corporation—Center for Outcomes Research and measuring quality of care associated endorsement. Between that initial MAP Evaluation (CORE). Measure Technical Report: with urology procedures performed at review in December 2016 and the CY Hospital Visits after Urology Ambulatory Surgical 2018 OPPS/ASC proposed rule, we Center Procedures (Version 1.0). May 2017. ASCs is patient-centered and is an Available at: https://www.cms.gov/Medicare/ important clinical care area to evaluate. completed field testing and refined the Quality-Initiatives-Patient-Assessment-Instruments/ 171 Comment: A few commenters measure. The final methodology HospitalQualityInits/Downloads/Version-10_ believed that the measure should be Hospital-Visits_Urology-ASC-Procedures_Measure- _ refined and resubmitted prior to 170 Spreadsheet of MAP 2017 Final Technical-Report 052017.pdf. Recommendations. February 1, 2017. Available at: 173 Horwitz, Leora I., et al. ‘‘Development and rulemaking, as suggested by the MAP. http://www.qualityforum.org/WorkArea/ validation of an algorithm to identify planned Several commenters noted or were linkit.aspx?LinkIdentifier=id&ItemID=84452. readmissions from claims data.’’ Journal of hospital concerned that the measure lacks NQF 171 MAP 2017 Considerations for Implementing medicine 10.10 (2015): 670–677. endorsement. A few commenters also Measures in Federal Programs: Hospitals. Final 174 Ranasinghe, Isuru, et al. ‘‘Differences in Report. February 15, 2017. Available at: http:// colonoscopy quality among facilities: development suggested that CMS seek input from the www.qualityforum.org/Publications/2017/02/2017_ of a post-colonoscopy risk-standardized rate of MAP on the finalized measure prior to Considerations_for_Implementing_Measures_Final_ unplanned hospital visits.’’ Gastroenterology 150.1 proposing for inclusion in the program. Report_-_Hospitals.aspx. (2016): 103–113.
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(1) A condition or diagnosis that is following outpatient urologic ASC–18. Specifically, some commenters considered to be always planned (such procedures. did not support adoption of the as transplants or maintenance In response to a commenter’s measure, because measure score chemotherapy); or (2) that are suggestion that we develop a numerator calculation relies on retrospective considered potentially planned (such as exclusion for unrelated hospital visits, claims data. The commenters expressed cardiovascular procedures) and are not this measure was intentionally designed concerns that the delay in providing accompanied by an acute diagnosis. The to broadly evaluate all-cause hospital data to facilities would provide limited planned admission algorithm is based visits to capture serious adverse events usefulness for quality improvement or on CMS’ widely-used Planned experience by patients after undergoing for consumers in choosing an ASC Readmission Algorithm v4.0.175 We urologic ASC procedures, rather than a facility. Regarding a similar measure, refer readers to the measure narrow set of identifiable complications, ASC–12 Facility Risk-Standardized Visit methodology report at: https:// for many reasons. The outcome of all- Rate after Outpatient Colonoscopy, one www.cms.gov/Medicare/Quality- cause hospital visits is consistent with commenter noted that in their members’ a patient-centric view of care that is Initiatives-Patient-Assessment- experience with the confidential designed to prompt ASC providers to Instruments/HospitalQualityInits/ feedback reports, facilities were already minimize the risk and reduce the need Measure-Methodology.html for more aware of most of the visits in the claims for a broad range of outcomes after details. detail report and did not review the undergoing urologic ASC procedures, reports unless the facilities were Regarding the commenter’s concerns including the risk of dehydration, categorized as underperforming. The about the attribution of outcomes, and nausea and vomiting, dizziness, and commenter also questioned the whether hospital visit within 7 days of urinary retention. Measuring only usefulness of the measure to make ASC procedure is a sign of poor quality, hospital visits that are overtly related to distinctions among facilities and to we believe that the measure captures the a procedure, such as visits for pain and consumers, because the performance for full range of potentially serious adverse bleeding, would limit the measure’s the overwhelming majority of the ASCs events related to urologic procedures intended broad impact on quality would be no different than expected. performed at ASCs. We designed the improvement efforts. These are common outcome timeframe to encompass the problems that may or may not be related Response: We acknowledge the first 7 days for capture of hospital visits to a recent ASC procedure. Thus, the commenters’ concerns regarding the use (ED visits, observation stays, and measure is structured so that facilities of claims data for the ASC–18 measure; unplanned admissions), because that most effectively minimize patient however, the measure would provide existing literature suggests that the vast risk of these outcomes will perform facilities with the most recently majority of adverse events after an better on the measure. available, patient-level data to help urology procedure occur within the first Comment: A commenter suggested guide quality improvement efforts that 7 days following the procedure 176 177 that CMS provide a detailed clinical would also be low burden. and because the highest rates of hospital review of all the measure results by Further, we believe that measures of several seasoned urologists to ensure the visits were observed in claims data hospital events following specific types measure algorithm is appropriate. of surgical procedures fully based on within 7 days following the procedure. Response: In developing the measure, A 7-day timeframe helps to ensure that we incorporated significant input from Medicare FFS claims recently adopted the measure will capture adverse events various experts and stakeholders. In (for example, ASC–12: Facility 7-Day following the procedure, but will not addition to the MUC and MAP Risk Standardized Hospital Visit Rate capture events impacted by factors processes described above, a after Outpatient Colonoscopy Measure) unrelated to the care patients multidisciplinary team of clinicians, and including those newly finalized in received.178 We appreciate the health services researchers, and this final rule that is, ASC–17: Hospital commenter’s careful review of the top statisticians were informed, in part, by Visits after Orthopedic Ambulatory hospital visit diagnoses within seven a national TEP consisting of patients, Surgical Center Procedures and ASC– days of urologic procedures. We methodologists, researchers, and 18: Hospital Visits after Urology welcome specific examples of providers, including urologists who Ambulatory Surgical Center Procedures) potentially planned admissions conducted a detailed clinical review of will better inform Medicare all the measure results to ensure the beneficiaries and other consumers about 175 Yale New Haven Health Services measure algorithm is appropriate. We post-procedure complication rates. Corporation—Center for Outcomes Research and also held a public comment period Existing ASC quality measures tend to Evaluation (CORE). Measure Technical Report: soliciting stakeholder input on the focus on very rare, patient safety-related Hospital Visits after Urology Ambulatory Surgical events. For example, ASC–3 counts Center Procedures (Version 1.0). May 2017. measure methodology, including the Available at: https://www.cms.gov/Medicare/ planned admission algorithm. However, cases in which a wrong site, wrong side, Quality-Initiatives-Patient-Assessment-Instruments/ we will continue to evaluate the wrong patient, wrong procedure, or HospitalQualityInits/Downloads/Version-10_ wrong implant event occurred (76 FR _ _ measure, as our goal is to ensure that the Hospital-Visits Urology-ASC-Procedures Measure- 74499).179 Technical-Report_052017.pdf. measure accurately reflects the quality Measures designed to capture 176 Fleisher LA, Pasternak LR, Herbert R, of care provided in ASCs. more common adverse outcomes that Anderson GF. Inpatient hospital admission and We appreciate the commenter’s patients experience, such as urinary death after outpatient surgery in elderly patients: careful review of the top hospital visit retention, urinary tract infection, pain, Importance of patient and system characteristics and other complications prompting and location of care. Archives of Surgery. diagnoses within seven days of urology 2004;139(1):67–72. procedures. We welcome specific acute care hospital visits or admissions 177 Mattila K, Toivonen J, Janhunen L, Rosenberg examples of potentially planned PH, Hynynen M. Postdischarge symptoms after admissions following outpatient 179 Centers for Medicare & Medicaid Services. ambulatory surgery: First-week incidence, intensity, urologic procedures. Ambulatory Surgical Center Quality Reporting and risk factors. Anesthesia and Analgesia. Specifications Manual Release Notes Version: 6.0. 2005;101(6):1643–1650. Comment: Several commenters were 2016; Available at: http://qualitynet.org/dcs/ 178 Parry, Nicola. ‘‘7-Day Readmissions: Better concerned that ASCs may not have ContentServer?c=Page&pagename=QnetPublic Indicators of Patient Care.’’ Medscape, 2016. actionable information generated from %2FPage%2FQnetTier2&cid=1228772475754.
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are lacking at this time, and this is what the time of the procedure. The candidate variables, which were the this measure is intended to accomplish. commenter noted that this type of variables that we considered for the While we appreciate the commenter’s condition is not something that risk-adjustment model. We agree with feedback that some ASCs were already develops acutely within the timeframe the commenter for noting that CC 82 is aware of most of the visits in the claims of an ASC procedure, but rather is unlikely to develop acutely during the detail report and did not review the reflective of a more chronic patient timeframe of a procedure; we will reports unless the facilities were condition. review this group of codes and will categorized as underperforming, that is Response: We understand the consider revising the list of CCs that are not always the case. Providers at ASCs important role that factors outside of an not risk-adjusted for if the condition are more often unaware of patients’ ASC’s control, for example, occurs at the time of the procedure. As subsequent acute care visits given that socioeconomic and sociodemographic explained above, this measure was separate providers (for example, status, play in the care of patients. reviewed using a consensus-driven emergency department physicians) tend Although the risk-adjustment approach, with input from a national to provide post-urological care when it methodology does not stratify by social TEP and surgeons, including urologists, is required.180 This measure is intended risk factors, it does account for risk by providing care in the ASC setting. to bring greater awareness to a larger adjusting for risk factors associated with Potential candidate risk factors and number of ASCs and patients, in increased risk for hospital visits after condition categories were identified addition to actionable information to surgery. In developing this measure, we from related quality measures and the lower the rate of preventable adverse evaluated the potential effects of risk literature; 184 185 186 a preliminary list of events and to improve the quality of adjusting for three socioeconomic status risk factors was developed and then care following procedures performed at (SES) factors that are available in CMS revised based on national TEP and an ASC. claims (Medicaid dual-eligibility status, clinical expert review that included Although the majority of ASCs would African-American race, and the AHRQ several urologists. These risk variables be expected to have risk-standardized SES index). Our results show that were further released and reviewed rates that would be classified as ‘‘no adjusting for these three factors at the during the measure development public different than the national rate’’ on patient level do not change the measure comment period prior to the selection of Hospital Compare, we believe that the scores. We assessed the relationship of the final model.187 This consensus- measure will be able to make distinction SES to hospital visits at the patient and based approach was used to achieve among facilities and to consumers facility levels. Unadjusted and adjusted clinical face validity prior to the model because the variation in risk- ASC-level risk-standardized hospital selection. standardized hospital visit rates across visit rates were highly correlated Comment: One commenter noted that ASCs nationally suggests that there is (Spearman correlation coefficients of low-volume situations tend to produce still room for quality improvement. nearly 1.0) when calculated with and measure scores that lack reliability. The Hospital Compare will also report without the addition of the three SES commenter noted that the measure is facilities’ risk-standardized rates, and variables (Medicaid dual-eligibility only ‘‘fairly’’ reliable and suggested the facilities will receive confidential status, African-American race, and the reliability for a measure intended for feedback reports to support quality AHRQ SES index). This indicates that public reporting should be substantially improvement efforts. Furthermore, including SES variables in ASC-level reliable, or have an ICC of 0.61 to 0.80. feedback from national TEP members risk-adjusted measure score will result Furthermore, the commenter noted that showed that the ASC–18 measure, as in limited differences in measure results the measure also suffers from limited specified, can be used to distinguish after accounting for other risk factors, discriminatory power because the between better and worse quality such as age and comorbidities. We refer number of underperforming facilities is facilities.181 This shows TEP agreement readers to the methodology in the very small. The commenter urged CMS with the overall face validity of the measure specifications for more to ensure that the publicly reported measure. information about SES testing for this scores are reliable. Comment: A few commenters measure at: https://www.cms.gov/ Response: We thank the commenter expressed concerns about risk Medicare/Quality-Initiatives-Patient- for their feedback about the measure adjustment. A commenter noted that the Assessment-Instruments/ reliability. We disagree with the measure is not risk adjusted to account HospitalQualityInits/Measure- commenter and believe that ASC–18 is for socioeconomic status and other Methodology.html. We also refer readers factors beyond a hospitals’ control. to section XIV.B.2. of this final rule with 184 Crew JP, Turner KJ, Millar J, Cranston DW. Is comment period where we discuss day case surgery in urology associated with high Another commenter expressed concern admission rates? Annals of The Royal College of about including condition category (CC social risk factors in the ASCQR Surgeons of England. 1997;79(6):416–419. 82), Respirator dependence/ Program in more detail. 185 Fleisher LA, Pasternak LR, Herbert R, tracheostomy status, on the list of Furthermore, we appreciate the Anderson GF. Inpatient hospital admission and condition categories that are not risk- commenter’s concern about including death after outpatient surgery in elderly patients: condition category (CC) 82 on the list of Importance of patient and system characteristics adjusted if the condition occurs only at and location of care. Archives of Surgery. condition categories that are not risk- 2004;139(1):67–72. 180 Mezei G, Chung F. Return hospital visits and adjusted for if they occur only at the 186 Paez A, Redondo E, Linares A, Rios E, Vallejo hospital readmissions after ambulatory surgery. time of the procedure.182 Condition J, Sanchez-Castilla M. Adverse events and Annals of Surgery. 1999;230(5):721–727. categories are used to classify diagnoses readmissions after day-case urological surgery. 181 Yale New Haven Health Services into clinically coherent groups.183 We International Brazilian Journal of Urology. Corporation—Center for Outcomes Research and 2007;33(3):330–338. Evaluation (CORE). Measure Technical Report: consolidated like risk factors into 187 Yale New Haven Health Services Corporation. Hospital Visits after Urology Ambulatory Surgical Hospital Visits after Orthopedic Ambulatory Center Procedures (Version 1.0). May 2017. 182 Ibid. Surgical Center Procedures (Version 1.0). May 2017. Available at: https://www.cms.gov/Medicare/ 183 HCUP CCS Fact Sheet. Healthcare Cost and Available at: https://www.cms.gov/Medicare/ Quality-Initiatives-Patient-Assessment-Instruments/ Utilization Project (HCUP). January 2012. Agency Quality-Initiatives-Patient-Assessment-Instruments/ HospitalQualityInits/Downloads/Version-10_ for Healthcare Research and Quality, Rockville, MD. HospitalQualityInits/Downloads/Version-10_ Hospital-Visits_Urology-ASC-Procedures_Measure- https://www.hcup-us.ahrq.gov/toolssoftware/ccs/ Hospital-Visits_Orthopedic-ASC-Procedures_ Technical-Report_052017.pdf. ccsfactsheet.jsp. Measure-Technical-Report_052017.pdf.
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sufficiently reliable to be included in facilities and to increase both the unanticipated nuances associated with the ASCQR Program. Our calculated reliability of the measure score and the measure implementation. intraclass correlation coefficient ability to discriminate performance As proposed we will not publicly (ICC),188 a measure of reliability or the across facilities. Furthermore, ASC report data for this measure until the CY degree to which the measure can facilities that have too few cases to 2022 payment determination and produce accurate and consistent results reliably estimate a measure score subsequent years. We do not believe across multiple measurements of the (moderate reliability as discussed in the publicly reporting data from the dry run same entities in a time period, for this prior paragraph) would be treated in the is appropriate as we might still be measure was 0.45, indicating same way as other facilities with too few working out unanticipated nuances; the ‘‘moderate’’ reliability.189 The NQF cases and would not have their scores data is preliminary and is therefore considers ICC values ranging from 0.01– posted on Hospital Compare; their data subject to change based on feedback 0.20 as ‘‘slight’’ reliability, 0.21–0.40 as would be replaced with a footnote. We provided by ASCs. ‘‘fair’’ reliability, 0.41 to 0.60 as discuss our Hospital Compare footnotes Comment: One commenter noted that ‘‘moderate’’ reliability, and 0.61 to 0.80 at: https://www.medicare.gov/ although CMS believes that there would as ‘‘strong’’ reliability.190 We disagree hospitalcompare/data/Footnotes.html. not be any additional burden because that the measure reliability should be However, these facilities will still ASCs are not required to submit ‘‘substantially’’ reliable or have an ICC receive confidential feedback reports/ additional data, reviewing claims detail of 0.61 to 0.80, and believe the publicly facility-specific reports providing reports and measure scores would be reported scores will be sufficiently valuable information about post-surgery associated with additional burden for reliable. The results of reliability testing events. We refer readers to section someone at ASCs, likely a clinician. are consistent with existing measures of XIV.B.6.c.(7) of this final rule with Response: We thank the commenter patient outcomes in the ambulatory comment period for more details about for providing this input and surgery setting.191 Therefore, we believe public reporting of this measure. We acknowledge that this measure will be the measure is sufficiently reliable. expect that smaller ASCs will still calculated completely from data already Regarding the comment about lack of benefit from confidentially reviewing obtained from paid Medicare FFS discriminatory power, we agree that the their measure results and individual claims submitted by ASCs, hospitals, many small-volume ASCs will limit the patient-level outcomes in the facility- and physicians for billing purposes. ability to make distinctions in specific report, as these data are Because claims data are used, there is performance between facilities. ASCs currently largely unknown to ASCs and no burden on the part of ASCs to submit with few cases in a given year limit our providers. additional data for measure calculation. ability to capture variation in ASC-level Comment: One commenter requested We strongly suggest that facilities measure scores because our modeling that the dry run results be aggregated allocate time to review their feedback methodology is conservative and will and made available in its entirety to the reports, because they contain actionable estimate measure scores toward the public for review and comment if the information to identify performance national mean for facilities with small measure is finalized. The commenter gaps and further develop quality volumes. Specifically, hospitals with also suggested that CMS conduct pilot improvement strategies. However, we relatively few cases in the performance testing for the measure with volunteer note that these activities do not period may have a true rate that is ASCs rather than conduct national dry represent burden related to program worse/better than the national average. runs. Another commenter suggested that requirements. However, the model estimates their rate CMS pilot test the measure prior to Comment: One commenter expressed as close to the mean because their low implementation to ensure that the concern over the measure specifications, volume does not provide enough measure adequately account for the including the accuracy of background information to accurately estimate a nuances related to urologic surgery. data on the number of unplanned value near their true rate. As a result, Response: We refer readers to section hospital visits. the model may capture less variation XIV.B.6.c.(7) of this final rule with Response: We interpret commenter to than truly exits due to low case sizes. To comment period where we discuss our be referring to Table 4 in the ASC–18 improve the measure’s ability to detect dry run. The intent of the dry run is to Measure Technical Report published in quality differences, we crafted our test production of the measure and for May 2017 and located at: https:// proposal to use 2 years of data for public ASCs to familiarize themselves with the www.cms.gov/medicare/Quality- reporting to expand the number of cases measure and provide feedback to CMS. Initiatives-Patient-Assessment- available for estimating rates across all The dry run will generate confidential Instruments/HospitalQualityInits/ reports for ASCs on measure Measure-Methodology.html. In the 188 Landis J, Koch G. The measurement of observer agreement for categorical data, Biometrics performance and risk-standardized technical report for this measure, the 1977;33:159–174. hospital visit rates, among other data. column labeled ‘‘number of unplanned 189 The NQF considers ICC values ranging from We plan to perform a dry run of the hospital visits’’ was incorrectly labeled 0.01–0.20 as ‘‘slight’’ reliability, 0.21–0.40 as ‘‘fair’’ measure prior to implementation. The and should read ‘‘number of procedure reliability, 0.41 to 0.60 as ‘‘moderate’’ reliability, performed.’’ The remainder of the table and 0.61 to 0.80 as ‘‘strong’’ reliability. Avalable at: confidential dry run results will not be http://www.qualityforum.org/Measuring_ publicly reported or used for payment is correct. We will address this Performance/Improving_NQF_Process/Measure_ determination. We believe a dry run discrepancy in future technical Testing_Task_Force_Final_Report.aspx. will be more beneficial than pilot documentation. We thank the 190 Landis J, Koch G. The measurement of testing. The dry run will include all commenter for pointing out the observer agreement for categorical data, Biometrics 1977;33:159–174. ASCs rather than just a subset of inconsistency. 191 See the Risk-Standardized Hospital Visits volunteer ASCs and will enable all After consideration of the public within 7 Days After Hospital Outpatient Surgery ASCs to gain familiarity with the comments we received, we are Measure. For ICC score of 0.50: Available at: https:// measure and processes, as well as finalizing the proposal to adopt the www.cms.gov/Medicare/Quality-Initiatives-Patient- ASC–18: Hospital Visits after Urology Assessment-Instruments/HospitalQualityInits/ provide feedback to CMS on both the Downloads/Hospital-Visits-after-Hospital- measure itself and the reports. This will Ambulatory Surgical Center Procedures Outpatient-Surgery-Measure.pdf. also enable CMS to learn about any measure in the ASCQR Program for the
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CY 2022 payment determination and d. Summary of Previously Adopted determination and subsequent years is subsequent years, as proposed. Measures and Newly Finalized ASCQR listed below. Program Measures for the CY 2022 Payment Determination and Subsequent Years The measure set for the ASCQR Program CY 2022 payment
ASCQR PROGRAM MEASURE SET WITH PREVIOUSLY AND NEWLY FINALIZED MEASURES FOR THE CY 2022 PAYMENT DETERMINATION AND SUBSEQUENT YEARS
ASC No. NQF No. Measure name
ASC–1 ...... 0263 ...... Patient Burn. ASC–2 ...... 0266 ...... Patient Fall. ASC–3 ...... 0267 ...... Wrong Site, Wrong Side, Wrong Patient, Wrong Procedure, Wrong Implant. ASC–4 ...... 0265 † ...... All-Cause Hospital Transfer/Admission. ASC–8 ...... 0431 ...... Influenza Vaccination Coverage among Healthcare Personnel. ASC–9 ...... 0658 ...... Endoscopy/Polyp Surveillance: Appropriate Follow-Up Interval for Normal Colonoscopy in Average Risk Pa- tients. ASC–10 ...... 0659 ...... Endoscopy/Polyp Surveillance: Colonoscopy Interval for Patients with a History of Adenomatous Polyps- Avoidance of Inappropriate Use. ASC–11 ...... 1536 ...... Cataracts: Improvement in Patient’s Visual Function within 90 Days Following Cataract Surgery.* ASC–12 ...... 2539 ...... Facility 7-Day Risk-Standardized Hospital Visit Rate after Outpatient Colonoscopy. ASC–13 ...... None ...... Normothermia Outcome. ASC–14 ...... None ...... Unplanned Anterior Vitrectomy. ASC–15a ...... None ...... OAS CAHPS—About Facilities and Staff.** ASC–15b ...... None ...... OAS CAHPS—Communication About Procedure.** ASC–15c ...... None ...... OAS CAHPS—Preparation for Discharge and Recovery.** ASC–15d ...... None ...... OAS CAHPS—Overall Rating of Facility.** ASC–15e ...... None ...... OAS CAHPS—Recommendation of Facility.** ASC–17 ...... None ...... Hospital Visits after Orthopedic Ambulatory Surgical Center Procedures.*** ASC–18 ...... None ...... Hospital Visits after Urology Ambulatory Surgical Center Procedures.*** † We note that NQF endorsement for this measure was removed. * Measure voluntarily collected effective beginning with the CY 2017 payment determination as set forth in section XIV.E.3.c. of the CY 2015 OPPS/ASC final rule with comment period (79 FR 66984 through 66985). ** Measure finalized for delay beginning with CY 2018 reporting until further action in future rulemaking as discussed in section XIV.B.4. of this final rule with comment period. *** New measure finalized for the CY 2022 payment determination and subsequent years.
7. ASCQR Program Measures and and coordination of care; promote mortality and cost burden of HAIs.193 Topics for Future Consideration effective prevention and treatment of Breast SSIs represent a substantial chronic disease; work with communities proportion of SSIs overall in inpatient In the CY 2013 OPPS/ASC final rule to promote best practices of healthy settings, and have one of the highest with comment period (77 FR 68493 living; and make care affordable. infection risks of any procedure type in through 68494), we set forth our We invited public comment on one outpatient settings.194 While SSI rates considerations in the selection of measure developed by the CDC for following breast procedures vary from ASCQR Program quality measures. We potential inclusion in the ASCQR one percent to over 30 percent seek to develop a comprehensive set of Program in future rulemaking, the depending on procedure type,195 the quality measures to be available for Ambulatory Breast Procedure Surgical widespread use for making informed Site Infection (SSI) Outcome measure 193 Ibid. decisions and quality improvement in (NQF #3025). This potential measure is 194 This statement is based on an analysis of data the ASC setting (77 FR 68496). We also discussed in more detail below. reported to the National Healthcare Safety Network (NHSN). Out of 67,150 ASC procedures report to seek to align these quality measures Healthcare-associated infections NHSN from 2010 to 2013, 30,787 (45.9 percent) with the National Quality Strategy (HAIs) are a major cause of morbidity were breast procedures. Out of the 142 surgical site (NQS), the CMS Strategic Plan (which and mortality in healthcare settings in infections reported from ASCs during the same time the United States, with the most recent period, 78 (54.9 percent) were related to breast includes the CMS Quality Strategy), and procedures, indicating an SSI risk of 0.25 percent. our other quality reporting and value- prevalence surveys of HAIs estimating This was the highest volume and SSI risk out of all based purchasing (VBP) programs, as that approximately four percent of outpatient ASC procedures reported in the appropriate. Accordingly, as we stated inpatients in acute care settings have timeframe. 195 in the CY 2015 OPPS/ASC final rule developed at least one HAI, translating Vilar-Compte D, Jacquemin B, Robles-Vidal C, to 721,800 infections in 648,000 patients and Volkow P. Surgical Site Infections in Breast with comment period (79 FR 66979), in Surgery: Case-Control Study. World Journal of 192 considering future ASCQR Program in 2011. Surgical site infection (SSI) Surgery. 2004;28(3):242–246; Mannien J., Wille JC, measures, we are focusing on the is one of the most common HAIs, Snoeren RL, van den Hof S. Impact of Postdischarge comprising approximately 22 percent of Surveillance on Surgical Site Infection Rates for following NQS and CMS Quality Several Surgical Procedures: Results from the Strategy measure domains: Make care all HAIs, and contribute greatly to the Nosocomial Surveillance Network in the safer by reducing harm caused in the Netherlands. Infection Control and Hospital 192 delivery of care; strengthen person and Magill SS, Edwards JR, Bamberg W, Beldavs Epidemiology. 2006;27:809–816; Vilar-Compte D., ZG, Dumyati G, Kainer MA. Multistate Point- Rosales S., Hernandez-Mello N, Maafs E and family engagement as partners in their Prevalence Survey of Health Care-Associated Volkow P. Surveillance, Control, and Prevention of care; promote effective communication Infections. NEJM. 2014;370:1198–1208. Surgical Site Infections in Breast Cancer Surgery: A
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trend in surgery transitioning to measure (MUC16–155), noting the rapid this measure for the ASC setting can be outpatient and ambulatory surgery shift of care to the ambulatory surgery found at: http://www.qualityforum.org/ settings due to advances in surgical setting and the need to ensure QPS/ after searching ‘‘Ambulatory techniques and economic incentives for transparency about the safety of Breast Procedure Surgical Site Infection ambulatory surgery make these events ambulatory surgery centers.202 The MAP Outcome Measure.’’ an outcome of interest for the ASCQR further noted that this measure should We invited public comment on the Program. be submitted for NQF review and possible inclusion of this measure in the Numerous individual studies and endorsement.203 A summary of the MAP ASCQR Program measure set in the systematic reviews provide strong recommendations can be found at: future. evidence that measurement and https://www.qualityforum.org/ Comment: Several commenters feedback of surgical site infections leads WorkArea/linkit.aspx?LinkIdentifier= supported the inclusion of the to lower SSI rates in the long term.196 id&ItemID=81593. We note that this Ambulatory Breast Procedure Surgical Although standardized metrics have measure received NQF endorsement in Site Infection (SSI) Outcome measure been developed to measure SSI rates for January 2017, and therefore satisfies the (NQF #3025) in the ASCQR Program in inpatient surgeries in the hospital MAP’s condition for support.204 future rulemaking, noting that the setting,197 these have not yet been The Ambulatory Breast Procedure measure is fully developed, was tested developed for outpatient surgeries in Surgical Site Infection Outcome in the ASC setting, and addresses an ASCs, which comprise a fast-growing measure is used to assess the risk- important area of care. One commenter proportion of all surgeries performed in adjusted Standardized Infection Ratio recommended that CMS consider the United States.198 We believe this (SIR) for all SSIs following breast refining this and other measures so that measure, if adopted in the future, could procedures conducted at ASCs among data is collected at the NPI level, rather serve as a quantitative guide for ASCs, adult patients and reported to the CDC’s than by CCN. One commenter agreed enabling them to benchmark SSI rates in National Healthcare Safety Network. that breast procedure SSI outcomes are their facilities against nationally The measure compares the reported a concern, but noted that significant aggregated data and set targets for number of SSIs observed at an ASC with development and testing may be improvement. a predicted value based on nationally required before the Ambulatory Breast This issue is of interest to the ASCQR aggregated data. The numerator for this Procedure Surgical Site Infection (SSI) Program because breast procedures are measure is all SSIs during the 30-day Outcome measure (NQF #3025) is ready becoming increasingly common at and 90-day postoperative periods for implementation due to the difficulty ASCs.199 In addition, the Ambulatory following breast procedures in ASCs. of capturing data on whether an SSI has Breast Procedure Surgical Site Infection The term SSI as used in this measure is occurred. One commenter expressed Outcome measure addresses the MAP- defined in accordance with the CDC concern that the measure could lead to identified measure gap area of surgical NHSN’s surveillance protocol as an unintended consequences related to the quality measures, including surgical site infection, following a breast procedure, administration of perioperative infection measures, for the ASCQR of either the skin, subcutaneous tissue antibiotics across breast procedures. Response: We thank commenters for Program.200 and breast parenchyma at the incision The Ambulatory Breast Procedure site (superficial incisional SSI), deep their support and recommendations. We Surgical Site Infection (SSI) Outcome soft tissues of the incision site (deep will consider the suggestions and measure was included on the 2016 MUC incisional SSI), or any part of the body concerns as we craft future policy. In addition, we note that our goal is to list 201 and reviewed by the MAP. The deeper than the fascial/muscle layers develop a parsimonious measure set MAP conditionally supported the that is opened or manipulated during the operative procedure (organ/space made up of meaningful measures that 205 5-year Experience. American Journal of Infection SSI). The denominator for this fill important gaps with consideration of Control. 2009;37(8):674–679. measure is all adult patients (defined as the impact on burden in the ASCQR 196 Anderson DJ, Podgorny K, Berrı´os-Torres S, et patients ages 18 to 108 years) Program. al. Strategies to Prevent Surgical Site Infections in undergoing breast procedures, as 8. Maintenance of Technical Acute Care Hospitals: 2014 Update. Infection specified by the operative codes that Control and Hospital Epidemiology. 2014;35:605– Specifications for Quality Measures 627; Mangram AJ, Horan TC, Pearson ML, Silver comprise the breast procedure category LC, Jarvis WR. Guideline for Prevention of Surgical of the NHSN Patient Safety Component We refer readers to the CY 2012 Site Infection. Hospital Infection Control Practices Protocol, at an ASC. This measure OPPS/ASC final rule with comment Advisory Committee. Infection Control and cohort excludes hospital inpatient and period (76 FR 74513 through 74514), Hospital Epidemiology. 1999; 20:250–278; Gaynes where we finalized our proposal to R, Richards C, Edwards JR, et al. Feeding Back outpatient departments, pediatric Surveillance Data to Prevent Hospital-Acquired patients (patients younger than 18 years) follow the same process for updating the Infections. Emerging Infectious Diseases. and very elderly patients (older than ASCQR Program measures that we 2001;7:295–298. 108 years), and brain-dead patients adopted for the Hospital OQR Program 197 Mu Y, et al. Improving Risk-Adjusted whose organs are being removed for measures, including the subregulatory Measures of Surgical Site Infection for the National Healthcare Safety Network. Infection Control and donor purposes. The specifications for process for making updates to the Hospital Epidemiology. 2011;32(10):970–986. adopted measures. In the CY 2013 198 Ibid. 202 National Quality Forum. 2016–2017 OPPS/ASC final rule with comment 199 Cullen KA, Hall MJ, Golosinskiy A, Statistics Spreadsheet of Final Recommendations to HHS and period (77 FR 68496 through 68497), the NFcH. Ambulatory Surgery in the United States, CMS, available at: https://www.qualityforum.org/ CY 2014 OPPS/ASC final rule with WorkArea/linkit.aspx?LinkIdentifier=id&ItemID= 2006. National Health Statistics Report; 2009. comment period (78 FR 75131), and the 200 National Quality Forum. ‘‘MAP 2017 81593. Considerations for Implementing Measures in 203 Ibid. CY 2015 OPPS/ASC final rule with Federal Programs: Hospitals.’’ Report. 2017. 204 National Quality Forum. Endorsed measure comment period (79 FR 66981), we Available at: http://www.qualityforum.org/map/ specification available at: http:// provided additional clarification under ‘‘Hospitals—Final Report.’’ www.qualityforum.org/QPS/3025. regarding the ASCQR Program policy in 201 Available at: http://www.qualityforum.org/ 205 Centers for Disease Control and Prevention. Setting_Priorities/Partnership/Measure_ ‘‘Surgical Site Infection (SSI) Event. Available at: the context of the previously finalized Applications_Partnership.aspx, under ‘‘2016 https://www.cdc.gov/nhsn/pdfs/pscmanual/9pscssi Hospital OQR Program policy, including Measures Under Consideration List (PDF).’’ current.pdf. the processes for addressing
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nonsubstantive and substantive changes public reporting policies associated We note that, in section XIV.B.3.b.(1) to adopted measures. In the CY 2016 with these measures. of this final rule with comment period, OPPS/ASC final rule with comment we are finalizing a proposal to remove C. Administrative Requirements period (80 FR 70531), we provided one claims-based measure using QDCs, clarification regarding our decision to 1. Requirements Regarding QualityNet ASC–5: Prophylactic Intravenous (IV) not display the technical specifications Account and Security Administrator Antibiotic Timing, beginning with the for the ASCQR Program on the CMS We refer readers to the CY 2014 CY 2019 payment determination. The Web site, but stated that we will OPPS/ASC final rule with comment following previously finalized claims- continue to display the technical period (78 FR 75132 through 75133) for based measures using QDCs will be specifications for the ASCQR Program a detailed discussion of the QualityNet collected for the CY 2020 payment on the QualityNet Web site. In addition, security administrator requirements, determination and subsequent years: our policies regarding the maintenance • ASC–1: Patient Burn; including setting up a QualityNet • of technical specifications for the account, and the associated timelines, ASC–2: Patient Fall; • ASC–3: Wrong Site, Wrong Side, ASCQR Program are codified at 42 CFR for the CY 2014 payment determination Wrong Patient, Wrong Procedure, 416.325. We did not propose any and subsequent years. In the CY 2016 Wrong Implant; and changes to our policies regarding the OPPS/ASC final rule with comment • maintenance of technical specifications ASC–4: Hospital Transfer/ period (80 FR 70533), we codified the Admission. for the ASCQR Program. administrative requirements regarding 9. Public Reporting of ASCQR Program maintenance of a QualityNet account 2. Minimum Threshold, Minimum Case Data and security administrator for the Volume, and Data Completeness for ASCQR Program at 42 CFR Claims-Based Measures Using QDCs In the CY 2012 OPPS/ASC final rule 416.310(c)(1)(i). We refer readers to We refer readers to the CY 2014 with comment period (76 FR 74514 section XIV.D.3.b.1. of this final rule OPPS/ASC final rule with comment through 74515), we finalized a policy to with comment period where we are period (78 FR 75135 through 75137), the make data that an ASC submitted for the finalizing our proposals to expand CY 2016 OPPS/ASC final rule with ASCQR Program publicly available on a submission via the CMS online tool to comment period (80 FR 70534 through CMS Web site after providing an ASC an also allow for batch data submission 70535) as well as 42 CFR 416.310(a)(3) opportunity to review the data to be and make corresponding changes to the and 42 CFR 416.305(c) for our policies made public. In the CY 2016 OPPS/ASC 42 CFR 416.310(c)(1)(i). about minimum threshold, minimum final rule with comment period (80 FR 2. Requirements Regarding Participation case volume, and data completeness for 70531 through 70533), we finalized our Status claims-based measures using QDCs. We policy to publicly display data by the did not propose any changes to these We refer readers to the CY 2014 National Provider Identifier (NPI) when policies. the data are submitted by the NPI and OPPS/ASC final rule with comment to publicly display data by the CCN period (78 FR 75133 through 75135) for 3. Requirements for Data Submitted via when the data are submitted by the a complete discussion of the an Online Data Submission Tool CCN. In addition, we codified our participation status requirements for the We refer readers to the CY 2012 policies regarding the public reporting CY 2014 payment determination and OPPS/ASC final rule with comment of ASCQR Program data at 42 CFR subsequent years. In the CY 2016 OPPS/ period (76 FR 74505 through 74509); CY 416.315 (80 FR 70533). In the CY 2017 ASC final rule with comment period (80 2014 OPPS/ASC final rule with OPPS/ASC final rule with comment FR 70533 and 70534), we codified these comment period (78 FR 75137 through period, we formalized our current requirements regarding participation 75140); CY 2015 OPPS/ASC final rule public display practices regarding status for the ASCQR Program at 42 CFR with comment period (79 FR 66983 timing of public display and the 416.305. We did not propose any through 66986); CY 2016 OPPS/ASC preview period by finalizing our changes to these policies. final rule with comment period (80 FR proposals to publicly display data on D. Form, Manner, and Timing of Data 70535 through 70536); CY 2017 OPPS/ the Hospital Compare Web site, or other Submitted for the ASCQR Program ASC final rule with comment period (81 CMS Web site as soon as practicable FR 79820 through 79822); and 42 CFR after measure data have been submitted 1. Requirements Regarding Data 416.310(c) for our previously finalized to CMS; to generally provide ASCs with Processing and Collection Periods for policies for data submitted via an online approximately 30 days to review their Claims-Based Measures Using Quality data submission tool. For more data before publicly reporting the data; Data Codes (QDCs) information on data submission using and to announce the timeframes for We refer readers to the CY 2014 QualityNet, we refer readers to: https:// each preview period starting with the OPPS/ASC final rule with comment www.qualitynet.org/dcs/Content CY 2018 payment determination on a period (78 FR 75135) for a complete Server?c=Page&pagename=Qnet CMS Web site and/or on our applicable summary of the data processing and Public%2FPage%2FQnetTier2&cid= listservs (81 FR 79819 through 79820). collection periods for the claims-based 1228773314768. We note that we are We did not propose any changes to measures using QDCs for the CY 2014 finalizing proposals to remove two these policies. However, we note that in payment determination and subsequent measures submitted via a CMS online section XIV.B.6.b. and c. of this final years. In the CY 2016 OPPS/ASC final data submission tool, ASC–6 and ASC– rule with comment period, we are rule with comment period (80 FR 7, in section XIV.B.3.b.(2) and finalizing two new measures: ASC–17: 70534), we codified the requirements XIV.B.3.b.(3) of this final rule with Hospital Visits after Orthopedic regarding data processing and collection comment period. We are not finalizing Ambulatory Surgical Center Procedures, periods for claims-based measures using our proposal to adopt one measure and ASC–18: Hospital Visits after QDCs for the ASCQR Program at 42 CFR submitted via a CMS online data Urology Ambulatory Surgical Center 416.310(a)(1) and (2). We did not submission tool, as described in section Procedures, beginning with the CY 2022 propose any changes to these XIV.B.6.a. of this final rule with payment determination, and specific requirements. comment period.
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a. Requirements for Data Submitted via proposed to expand the CMS online tool addition, as noted above, we proposed a Non-CMS Online Data Submission to also allow for batch submission to expand the CMS online tool to allow Tool beginning with data submitted during for batch submission beginning with We refer readers to CY 2014 OPPS/ CY 2018 for the CY 2020 payment data submitted during CY 2018 for the ASC final rule with comment period (78 determination and subsequent years. CY 2020 payment determination and Batch submission is submission of FR 75139 through 75140) and CY 2015 subsequent years, such that the option data for multiple facilities OPPS/ASC final rule with comment will be available prior to the 2018 data simultaneously using a single, period (79 FR 66985 through 66986) for submission deadline. electronic file containing data from After consideration of the public our requirements regarding data multiple facilities submitted via one comments we received, we are submitted via a non-CMS online data agent QualityNet account. Under the finalizing our proposals to: (1) Expand submission tool (CDC NHSN Web site). batch submission process, ASC agents the CMS online tool to also allow for We codified our existing policies (for example, a corporate representative batch submission of measure data regarding the data collection time for a corporate entity consisting of beginning with data submitted during periods for measures involving online multiple ASC facilities with separate CY 2018, and (2) make corresponding data submission and the deadline for NPIs) would be assigned a vendor ID changes to modify 42 CFR data submission via a non-CMS online and an ASC’s representative would 416.310(c)(1)(i). data submission tool at 42 CFR submit the Security Administrator (SA) 416.310(c)(2). Currently, we only have form with the assigned vendor ID for the (2) Measures Using the CMS Online one measure (ASC–8: Influenza agent to establish their own QualityNet Data Submission Tool for the CY 2020 Vaccination Coverage among Healthcare account. Once approved, the agent may Payment Determination and Subsequent Personnel) that is submitted via a non- submit data for any ASC associated with Years CMS online data submission tool. that ID, individually or in a batch, and In sections XIV.B.3.b.(2) and We did not propose any changes to access data reports for the same ASCs. XIV.B.3.b.(3) of this final rule with the reporting requirements for this Agents would only have access to data comment period, respectively, we are measure. reports for facilities that have finalizing proposals to remove two b. Requirements for Data Submitted via authorized them to have access. For measures collected via a CMS online a CMS Online Data Submission Tool batch submission, agents would be data submission tool—ASC–6: Safe provided the HQR external file layout Survey Checklist Use and ASC–7: ASC We refer readers to the CY 2014 with which to upload their associated Facility Volume Data on Selected OPPS/ASC final rule with comment ASCs’ data under the agents’ QualityNet Surgical Procedures—beginning with period (78 FR 75137 through 75139), CY account. In order to submit batch data, the CY 2019 payment determination. 2016 OPPS/ASC final rule with agents would need to meet all The following previously finalized comment period (80 FR 70535 through QualityNet account requirements, such measures will require data to be 70536), CY 2017 OPPS/ASC final rule as establishing a QualityNet account submitted via a CMS online data with comment period (81 FR 79821 and maintaining a QualityNet security submission tool for the CY 2020 through 79822), and 42 CFR administrator. Additional details payment determination and subsequent 416.310(c)(1) for our requirements regarding logistics of batch data years: regarding data submitted via a CMS submission would be included in future • ASC–9: Endoscopy/Polyp online data submission tool. We are guidance in the Specifications Manual. Surveillance: Appropriate Follow-Up currently using the QualityNet Web site In addition, we proposed to make Interval for Normal Colonoscopy in as our CMS online data submission tool: corresponding changes to 42 CFR Average Risk Patients; https://www.qualitynet.org/dcs/Content 416.310(c)(1)(i) to reflect this proposal • ASC–10: Endoscopy/Polyp Server?c=Page&pagename= and replace the term ‘‘ASCs’’ with the Surveillance: Colonoscopy Interval for QnetPublic%2FPage%2FQnetHome phrase ‘‘ASCs, and any agents Patients with a History of Adenomatous page&cid=1120143435383. In the CY submitting data on an ASC’s behalf.’’ Polyps—Avoidance of Inappropriate 2018 OPPS/ASC proposed rule (82 FR We invited public comment on our Use; and 33701), we made one proposal to proposals, as discussed above, to: (1) • ASC–11: Cataracts: Improvement in expand the method of data submission Expand the CMS online tool to also Patients’ Visual Function within 90 via a CMS online data submission tool. allow for batch submission of measure Days Following Cataract Surgery.206 (1) Batch Submission data beginning with data submitted We are not finalizing our proposal to during CY 2018, and (2) make adopt one new measure collected via a We did not propose any changes to corresponding changes to modify 42 CMS online data submission tool, ASC– our policies regarding data submitted CFR 416.310(c)(1)(i) to reflect the 16: Toxic Anterior Segment Syndrome, via a CMS online data submission tool aforementioned proposal. beginning with the CY 2021 payment when data is entered for individual Comment: Several commenters determination, as described in section facilities. Currently, for individual supported the proposal to allow batch XIV.B.6.a. of this final rule with facility data entry, users must have a submission, noting that it will increase comment period. QualityNet account and use one submission efficiency and decrease Hospital Quality Reporting (HQR) administrative burden. One commenter 4. Requirements for Non-QDC Based, External File per facility that is requested that the process for batch Claims-Based Measure Data uploaded into the QualityNet secure submission be determined in a timely We refer readers to the CY 2015 portal. However, using one HQR fashion to allow ASCs to use this option OPPS/ASC final rule with comment External File that only allows data entry prior to the 2018 data submission for one facility can be burdensome for deadline. 206 We note that the ASC–11 measure is entities responsible for submitting such Response: We thank the commenters voluntarily collected effective beginning with the CY 2017 payment determination, as set forth in data for multiple facilities, such as for their support and agree that batch section XIV.E.3.c. of the CY 2015 OPPS/ASC final multi-facility ASCs. Therefore, in an submission will increase efficiency and rule with comment period (79 FR 66984 through effort to streamline the process, we decrease administrative burden. In 66985).
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period (79 FR 66985) and the CY 2016 questions—the ‘‘gender’’ and ‘‘age’’ following the date that the extraordinary OPPS/ASC final rule with comment questions—from the OAS CAHPS circumstance occurred versus within 90 period (80 FR 70536) for our previously Survey in a future update. days following the date the adopted policies regarding data Comment: A few commenters extraordinary circumstance occurred; processing and collection periods for supported removal of the gender and (3) inconsistency regarding specification claims-based measures for the CY 2018 age questions from the survey. of a timeline for us to provide our payment determination and subsequent Response: We thank the commenters formal response notifying the facility or years. In addition, in the CY 2016 for their suggestions. We will take these hospital of our decision; (4) OPPS/ASC final rule with comment comments under consideration as we inconsistency regarding specification of period (80 FR 70536), we codified these craft policies for the OAS CAHPS our authority to grant ECEs due to CMS policies at 42 CFR 416.310(b). We did Survey. data system issues; and (5) referring to not propose any changes to these the program as ‘‘extraordinary requirements. 6. Extraordinary Circumstances extensions/exemptions’’ versus as We note that one previously finalized Extensions or Exemptions for the CY ‘‘extraordinary circumstances measure, ASC–12: Facility 7-Day Risk- 2019 Payment Determination and exceptions.’’ We believe addressing Standardized Hospital Visit Rate after Subsequent Years these five areas, as appropriate, can Outpatient Colonoscopy, will be a. Background improve administrative efficiencies for collected via claims for the CY 2020 affected facilities or hospitals. We note We refer readers to the FY 2013 IPPS/ payment determination and subsequent that, in the FY 2018 IPPS/LTCH PPS LTCH PPS final rule (77 FR 53642 years (79 FR 66970 through 66978). In final rule, we examined our policies in through 53643), the CY 2014 OPPS/ASC addition, in sections XIV.B.6.b. and c., these areas for the Hospital final rule with comment period (78 FR respectively, of this final rule with Readmissions Reduction Program, the 75140 through 75141), the CY 2017 comment period, we are finalizing our HAC Reduction Program, the Hospital OPPS/ASC final rule with comment proposals to adopt two new claims- IQR Program, the PCHQR Program and period (81 FR 79824 through 79825), based measures—ASC–17: Hospital the IPFQR Program (82 FR 38240, and 42 CFR 416.310(d) for the ASCQR Visits after Orthopedic Ambulatory 38277, 38410, 38425 and 38473 through Surgical Center Procedures, and ASC– Program’s policies for extraordinary 38474, respectively) and finalized 18: Hospital Visits after Urology circumstance extensions or exemptions 207 proposals to address differences in these Ambulatory Surgical Center (ECE) requests. areas for those programs. In section Procedures—beginning with the CY Many of our quality reporting and XIII.D.8. of this final rule with comment 2022 payment determination. value-based purchasing programs share period, we are also finalizing revisions a common process for requesting an to our ECE policies for the Hospital 5. Requirements for Data Submission for exception from program reporting due ASC–15a–e: Outpatient and Ambulatory OQR Program. to an extraordinary circumstance not With the exception of the terminology Surgery Consumer Assessment of within a provider’s control. We refer used to describe these processes (item 5 Healthcare Providers and Systems (OAS readers to the Hospital IQR Program (76 above), the ASCQR Program is aligned CAHPS) Survey-Based Measures FR 51615 through 51652, 78 FR 50836 with other quality reporting programs. We refer readers to the CY 2017 through 50837, 79 FR 50277, 81 FR As a result, in the CY 2018 OPPS/ASC OPPS/ASC final rule with comment 57181 through 57182, and 42 CFR proposed rule (82 FR 33702), we period (81 FR 79822 through 79824) for 412.140(c)(2)), the Hospital OQR proposed to rename the process as the our previously finalized policies Program (77 FR 68489, 78 FR 75119 extraordinary circumstances exceptions regarding survey administration and through 75120, 79 FR 66966, and 80 FR (ECE) policy and make conforming vendor requirements for the CY 2020 70524), the IPFQR Program (77 FR changes to 42 CFR 416.310(d). These are payment determination and subsequent 53659 through 53660 and 79 FR 45978), discussed below. years. In addition, we codified these and the PCHQR Program (78 FR 50848), policies at 42 CFR 416.310(e). However, as well as the HAC Reduction Program b. ECE Policy Nomenclature in section XIV.B.4. of this final rule with (80 FR 49542 through 49543) and the We have observed that while all comment period, we are finalizing a Hospital Readmissions Reduction quality programs listed above have proposal to delay implementation of the Program (80 FR 49542 through 49543), developed similar policies to provide ASC–15a–e: OAS CAHPS Survey-based for program-specific information about exceptions from program requirements measures beginning with the CY 2020 extraordinary circumstances exemption to facilities that have experienced payment determination (CY 2018 data requests. As noted below, some of these extraordinary circumstances, such as submission) until further action in policies were updated in the FY 2018 natural disasters, these programs refer to future rulemaking and refer readers to IPPS/LTCH PPS final rule. these policies using inconsistent that section for more details. In reviewing the policies for these terminology. Some programs refer to As noted in the CY 2017 OPPS/ASC programs, we recognized that there are these policies as ‘‘extraordinary final rule with comment period (81 FR five areas in which these programs have circumstances extensions/exemptions’’ 79815), some commenters suggested variances regarding ECE requests. These while others refer to the set of policies shortening sections of the survey, such are: (1) Allowing the facilities or as ‘‘extraordinary circumstances as the ‘‘About You’’ section. We hospitals to submit a form signed by the exceptions.’’ Several programs continue to evaluate the utility of facility’s or hospital’s CEO versus CEO (specifically, the Hospital VBP Program, individual questions as we collect new or designated personnel; (2) requiring the HAC Reduction Program, and the data from the survey’s voluntary the form be submitted within 30 days Hospital Readmissions Reduction national implementation, and will Program) are not able to grant consider different options for shortening 207 In the CY 2015 OPPS/ASC final rule with extensions to required data reporting the OAS CAHPS Survey without the comment period (79 FR 66987), we stated that we timelines due to their reliance on data will refer to the process as the ‘‘Extraordinary loss of important data in the future. Circumstances Extensions or Exemptions’’ process external to their program, and thus the Specifically, we continue to consider rather than the ‘‘Extraordinary Circumstances term, ‘‘extraordinary circumstances the removal of two demographic Extensions or Waivers’’ process. extensions/exemptions’’ is not
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applicable to all programs. However, all reductions for ASCs that fail to meet the The ASC conversion factor is used to of the described programs are able to ASCQR Program requirements. calculate the ASC payment rate for offer exceptions from their reporting services with the following payment 2. Reduction to the ASC Payment Rates requirements. Therefore, in an effort to indicators (listed in Addenda AA and for ASCs That Fail To Meet the ASCQR align across CMS quality programs, we BB to the proposed rule, which are Program Requirements for a Payment proposed to change the name of this available via the Internet on the CMS Determination Year policy from ‘‘extraordinary Web site): ‘‘A2’’, ‘‘G2’’, ‘‘P2’’, ‘‘R2’’ and circumstances extensions or exemption’’ The national unadjusted payment ‘‘Z2’’, as well as the service portion of to ‘‘extraordinary circumstances rates for many services paid under the device-intensive procedures identified exceptions’’ for the ASCQR Program, ASC payment system equal the product by ‘‘J8’’ (77 FR 68500). We finalized our beginning January 1, 2018, and to revise of the ASC conversion factor and the proposal that payment for all services § 416.310(d) of our regulations to reflect scaled relative payment weight for the assigned the payment indicators listed this change. APC to which the service is assigned. above would be subject to the reduction We invited public comment on these Currently, the ASC conversion factor is of the national unadjusted payment proposals as discussed above. equal to the conversion factor calculated rates for applicable ASCs using the Comment: A few commenters for the previous year updated by the ASCQR Program reduced update supported the proposal to align the ECE multifactor productivity (MFP)-adjusted conversion factor (77 FR 68500). policy with other quality reporting CPI–U update factor, which is the The conversion factor is not used to programs. adjustment set forth in section calculate the ASC payment rates for Response: We thank commenters for 1833(i)(2)(D)(v) of the Act. The MFP- separately payable services that are their support. adjusted CPI–U update factor is the assigned status indicators other than After consideration of the public Consumer Price Index for all urban payment indicators ‘‘A2’’, ‘‘G2’’, ‘‘J8’’, comments we received, we are consumers (CPI–U), which currently is ‘‘P2’’, ‘‘R2’’ and ‘‘Z2.’’ These services finalizing the proposals to rename the the annual update for the ASC payment include separately payable drugs and process as the extraordinary system, minus the MFP adjustment. As biologicals, pass-through devices that circumstances exceptions (ECE) policy discussed in the CY 2011 MPFS final are contractor-priced, brachytherapy and make conforming changes to 42 rule with comment period (75 FR sources that are paid based on the OPPS CFR 416.310(d). 73397), if the CPI–U is a negative payment rates, and certain office-based number, the CPI–U would be held to procedures, certain radiology services c. Timeline for CMS Response to ECE zero. Under the ASCQR Program in and diagnostic tests where payment is Requests accordance with section 1833(i)(7)(A) of based on the MPFS nonfacility PE RVU- We also note that we believe it is the Act and as discussed in the CY 2013 based amount, and a few other specific important for facilities to receive timely OPPS/ASC final rule with comment services that receive cost-based payment (77 FR 68500). As a result, we also feedback regarding the status of ECE period (77 FR 68499), any annual finalized our proposal that the ASC requests. We strive to complete our increase shall be reduced by 2.0 payment rates for these services would review of each ECE request as quickly percentage points for ASCs that fail to not be reduced for failure to meet the as possible. However, we recognize that meet the reporting requirements of the ASCQR Program requirements because the number of requests we receive, and ASCQR Program. This reduction the payment rates for these services are the complexity of the information applied beginning with the CY 2014 not calculated using the ASC conversion provided impacts the actual timeframe payment rates (77 FR 68500). For a factor and, therefore, not affected by to make ECE determinations. To complete discussion of the calculation reductions to the annual update (77 FR improve transparency of our process, we of the ASC conversion factor, we refer believe it is appropriate to clarify that 68500). readers to section XII.G. of this final rule Office-based surgical procedures we will strive to complete our review of with comment period. (performed more than 50 percent of the each request within 90 days of receipt. In the CY 2013 OPPS/ASC final rule time in physicians’ offices) and 7. ASCQR Program Reconsideration with comment period (77 FR 68499 separately paid radiology services Procedures through 68500), in order to implement (excluding covered ancillary radiology the requirement to reduce the annual We refer readers to the FY 2013 IPPS/ services involving certain nuclear update for ASCs that fail to meet the medicine procedures or involving the LTCH PPS final rule (77 FR 53643 ASCQR Program requirements, we through 53644), the CY 2014 OPPS/ASC use of contrast agents) are paid at the finalized our proposal that we would lesser of the MPFS nonfacility PE RVU- final rule with comment period (78 FR calculate two conversion factors: A full based amounts or the amount calculated 75141), the CY 2016 OPPS/ASC final update conversion factor and an ASCQR under the standard ASC ratesetting rule with comment period (80 FR Program reduced update conversion methodology. Similarly, in section 70537), and 42 CFR 416.330 for the factor. We finalized our proposal to XII.D.2.b. of the CY 2015 OPPS/ASC ASCQR Program’s reconsideration calculate the reduced national final rule with comment period (79 FR policy. We did not propose any changes unadjusted payment rates using the 66933 through 66934), we finalized our to this policy. ASCQR Program reduced update proposal that payment for the new E. Payment Reduction for ASCs That conversion factor that would apply to category of covered ancillary services Fail To Meet the ASCQR Program ASCs that fail to meet their quality (that is, certain diagnostic test codes Requirements reporting requirements for that calendar within the medical range of CPT codes year payment determination. We for which separate payment is allowed 1. Statutory Background finalized our proposal that application under the OPPS and when they are We refer readers to section XVI.D.1. of of the 2.0 percentage point reduction to integral to covered ASC surgical the CY 2013 OPPS/ASC final rule with the annual update may result in the procedures) will be at the lower of the comment period (77 FR 68499) for a update to the ASC payment system MPFS nonfacility PE RVU-based (or detailed discussion of the statutory being less than zero prior to the technical component) amount or the background regarding payment application of the MFP adjustment. rate calculated according to the standard
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ASC ratesetting methodology. In the CY XV. Files Available to the Public via the B. ICRs for the Hospital OQR Program Internet 2013 OPPS/ASC final rule with 1. Background comment period (77 FR 68500), we The Addenda to the OPPS/ASC The Hospital OQR Program is finalized our proposal that the standard proposed rules and the final rules with generally aligned with the CMS quality ASC ratesetting methodology for this comment period are published and reporting program for hospital inpatient type of comparison would use the ASC available only via the Internet on the conversion factor that has been services known as the Hospital IQR CMS Web site. To view the Addenda to Program (82 FR 20031 through 20075). calculated using the full ASC update this final rule with comment period adjusted for productivity. This is We refer readers to the CY 2011 through pertaining to CY 2018 payments under CY 2017 OPPS/ASC final rules with necessary so that the resulting ASC the OPPS, we refer readers to the CMS comment periods (75 FR 72111 through payment indicator, based on the Web site at: http://www.cms.gov/ 72114; 76 FR 74549 through 74554; 77 comparison, assigned to these Medicare/Medicare-Fee-for-Service- FR 68527 through 68532; 78 FR 75170 procedures or services is consistent for Payment/HospitalOutpatientPPS/ through 75172; 79 FR 67012 through each HCPCS code, regardless of whether Hospital-Outpatient-Regulations-and- 67015; 80 FR 70580 through 70582; and payment is based on the full update Notices.html; select ‘‘1678–FC’’ from the 81 FR 79862 through 79863, conversion factor or the reduced update list of regulations. All OPPS Addenda to respectively) for detailed discussions of conversion factor. this final rule with comment period are Hospital OQR Program information For ASCs that receive the reduced contained in the zipped folder entitled collection requirements we have ASC payment for failure to meet the ‘‘2018 OPPS 1678–FC Addenda’’ at the previously finalized. The information ASCQR Program requirements, we bottom of the page. To view the collection requirements associated with believe that it is both equitable and Addenda to this final rule with the Hospital OQR Program are currently appropriate that a reduction in the comment period pertaining to CY 2018 approved under OMB control number payment for a service should result in payments under the ASC payment 0938–1109. system, we refer readers to the CMS proportionately reduced coinsurance In section XIII.B.4.c. of this final rule Web site at: http://www.cms.gov/ liability for beneficiaries (77 FR 68500). with comment period, we are finalizing Medicare/Medicare-Fee-for-Service- Therefore, in the CY 2013 OPPS/ASC the removal of six measures. Payment/ASCPayment/ASC- final rule with comment period (77 FR Specifically, beginning with the CY Regulations-and-Notices.html; select 68500), we finalized our proposal that 2020 payment determination, we are ‘‘1678–FC’’ from the list of regulations. the Medicare beneficiary’s national finalizing, as proposed, to remove: (1) All ASC Addenda to this final rule with unadjusted coinsurance for a service to OP–21: Median Time to Pain comment period are contained in the Management for Long Bone Fracture; which a reduced national unadjusted zipped folders entitled ‘‘Addendum AA, and (2) OP–26: Hospital Outpatient payment rate applies will be based on BB, DD1, DD2, and EE.’’ Volume Data on Selected Outpatient the reduced national unadjusted Surgical Procedures. Also, while we payment rate. XVI. Collection of Information Requirements proposed to remove: (1) OP 1: Median In that final rule with comment Time to Fibrinolysis, (2) OP–4: Aspirin period, we finalized our proposal that A. Statutory Requirement for at Arrival, (3) OP–20: Door to Diagnostic all other applicable adjustments to the Solicitation of Comments Evaluation by a Qualified Medical ASC national unadjusted payment rates Under the Paperwork Reduction Act Professional, and (4) OP–25: Safe would apply in those cases when the of 1995, we are required to provide 60- Surgery Checklist beginning with the annual update is reduced for ASCs that day notice in the Federal Register and CY 2021 payment determination, we are fail to meet the requirements of the solicit public comment before a finalizing removal of these measures ASCQR Program (77 FR 68500). For collection of information requirement is with modification so that removal example, the following standard submitted to the Office of Management begins with the CY 2020 payment adjustments would apply to the reduced and Budget (OMB) for review and determination, one year earlier than national unadjusted payment rates: The approval. In order to fairly evaluate proposed. To summarize, the following wage index adjustment; the multiple whether an information collection measures will be removed for the CY procedure adjustment; the interrupted should be approved by OMB, section 2020 payment determination: (1) OP–1: procedure adjustment; and the 3506(c)(2)(A) of the Paperwork Median Time to Fibrinolysis; (2) OP–4: adjustment for devices furnished with Reduction Act of 1995 requires that we Aspirin at Arrival; (3) OP–20: Door to full or partial credit or without cost (77 solicit comment on the following issues: Diagnostic Evaluation by a Qualified FR 68500). We believe that these • The need for the information Medical Professional; (4) OP–21: adjustments continue to be equally collection and its usefulness in carrying Median Time to Pain Management for applicable to payment for ASCs that do out the proper functions of our agency. Long Bone Fracture; (5) OP–25: Safe not meet the ASCQR Program • The accuracy of our estimate of the Surgery Checklist; and (6) OP–26: requirements (77 FR 68500). information collection burden. Hospital Outpatient Volume Data on • Selected Outpatient Surgical In the CY 2015, CY 2016 and CY 2017 The quality, utility, and clarity of Procedures. We expect these finalized OPPS/ASC final rules with comment the information to be collected. • Recommendations to minimize the proposals will reduce the burden of period (79 FR 66981 through 66982; 80 information collection burden on the reporting for the Hospital OQR Program, FR 70537 through 70538; and 81 FR affected public, including automated as discussed in more detail below. We 79825 through 79826, respectively), we collection techniques. note that we discuss only the changes in did not make any other changes to these In the CY 2018 OPPS/ASC proposed burden resulting from the provisions in policies. rule (82 FR 33705 through 33710), we this final rule with comment period. In the CY 2018 OPPS/ASC proposed solicited public comment on each of In section XIII.B.10.b. of this final rule rule (82 FR 33702 through 33703), we these issues for the following sections of with comment period, we are finalizing did not propose any changes to these this document that contain information our proposal, with modification, to policies for CY 2018. collection requirements (ICRs). publicly report OP–18c using data
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beginning with patient encounters hospitals to pay for staff that abstract for use in this program, because such a during the third quarter of CY 2017. and submit clinical data. In CY 2018 technician is described as an individual However, we do not expect our OPPS/ASC proposed rule (82 FR 33705), who compiles, processes, and maintains modifications to affect the burden we proposed a new cost to hospitals and medical records of hospital and clinic estimates made in the CY 2018 OPPS/ specified that this cost included both patients in a manner consistent with ASC proposed rule (82 FR 33705 wage and overhead and fringe benefit medical, administrative, ethical, legal, through 33708), as discussed below. costs. Specifically, we proposed to and regulatory requirements of the In section XIII.B.5. of this final rule estimate that reporting data for the health care system.212 We previously with comment period, we are finalizing Hospital OQR Program can be estimated a total cost to hospitals of $30 our proposal to delay the OP–37a–e: accomplished by staff with a median per hour (80 FR 70581), though we have Outpatient and Ambulatory Surgery hourly wage of $18.29 per hour.208 This not previously specified whether that Consumer Assessment of Healthcare labor rate is based on the Bureau of rate included overhead and fringe Providers and Systems (OAS CAHPS) Labor Statistics (BLS) median hourly benefits as well as wage. We note that Survey-based measures beginning with wage for a medical records and health our current calculations result in a the CY 2020 payment determination (CY information technician. The BLS is the higher estimate of total hourly cost for 2018 data collection period) until principal Federal agency responsible for hospitals, as we proposed to use a further notice in future rulemaking. measuring labor market activity, median hourly wage of $18.29 per hour In addition, in this final rule with working conditions, and price changes and double it to account for overhead comment period, beginning with the CY in the economy.209 Acting as an and fringe benefits ($18.29 × 2 = 2020 payment determination, we are independent agency, the BLS provides $36.58), resulting in a higher hourly cost finalizing our proposals: (1) To codify at objective information for not only the to hospitals of $36.58 per hour § 419.46(e) our previously finalized government, but also for the public.210 (compared to $30 per hour) to estimate process for targeting hospitals for The BLS describes medical records and burden in the Hospital OQR Program. validation of chart-abstracted measures health information technicians as those After consideration of the public (section XIII.D.7.b. of this final rule with responsible for processing and comment we received, we are finalizing comment period); (2) to formalize the maintaining health information data.211 our estimates, as presented in the educational review process and use it to Therefore, we believe is reasonable to proposed rule to: (1) Estimate that correct incorrect validation results for assume that these individuals would be reporting data for the Hospital OQR chart-abstracted measures (section tasked with abstracting clinical data for Program can be accomplished by staff XIII.D.7.c. of this final rule with the Hospital OQR Program measures. with a median hourly wage of $18.29 comment period); (3) to align the first We also proposed to calculate the cost per hour, and (2) calculate the cost of quarter for which hospitals must submit of overhead, including fringe benefits, at overhead, including fringe benefits, at data for all hospitals that did not 100 percent of the mean hourly wage. 100 percent of the mean hourly wage. participate in the previous year’s This is necessarily a rough adjustment, These result in a wage plus benefits Hospital OQR Program, and make both because fringe benefits and estimate of $36.58 for the Hospital OQR corresponding revisions at 42 CFR overhead costs vary significantly from Program. 419.46(c)(3) (section XIII.D.1. of this employer to employer and because 3. Estimated Burden Due to Newly final rule with comment period); and (4) methods of estimating these costs vary Finalized Proposal To Delay OP–37a–e: to align the naming of the Extraordinary widely from study to study. Outpatient and Ambulatory Surgery Circumstances Exceptions (ECE) policy Nonetheless, we believe that doubling and make conforming changes to the × Consumer Assessment of Healthcare the hourly wage rate ($18.29 2 = Providers and Systems (OAS CAHPS) CFR (section XIII.D.8.a. of this final rule $36.58) to estimate total cost is a with comment period). We are not Survey-Based Measures Beginning With reasonably accurate estimation method. the CY 2020 Payment Determination finalizing our proposal to change the Accordingly, we calculate cost burden NOP submission deadlines such that to hospitals using a wage plus benefits As described in section XIII.B.5. of hospitals are required to submit the estimate of $36.58 throughout the this final rule with comment period, we NOP any time prior to registering on the discussion below for the Hospital OQR are finalizing our proposal to delay OP– QualityNet Web site and to make Program. 37a–e: Outpatient and Ambulatory conforming revisions at 42 CFR We invited public comment on these Surgery Consumer Assessment of 419.46(a) (section XIII.C.2.b. of this final proposals. Healthcare Providers and Systems (OAS rule with comment period). We do not Comment: One commenter expressed CAHPS) Survey-based measures believe that these changes will affect our concern that a medical records and beginning with the CY 2020 payment burden estimates, as further discussed health information technician with a determination (CY 2018 data collection below. wage of $18.29 per hour is not period). As we stated in the CY 2017 appropriate to complete chart- OPPS/ASC final rule with comment 2. Newly Finalized Change in Hourly abstraction and requested that we not period (81 FR 79863), the information Labor Cost for Burden Calculation for reduce the estimated hourly wage rate collection requirements associated with the Hospital OQR Program from previous years. the five OAS CAHPS Survey-based In previous rules (80 FR 70581), we Response: We note that we believe the measures (OP–37a, OP–37b, OP–37c, estimated that a hospital pays an wage for a medical records and health OP–37d, and OP–37e) are currently individual approximately $30 per hour information technician is appropriate approved under OMB Control Number to abstract and submit clinical data. We 0938–1240. For this reason, in the CY previously did not specify whether our 208 BLS Occupational Employment Statistics; May 2017 OPPS/ASC final rule with wage estimate of $30 included overhead 2016. Available at: https://www.bls.gov/oes/current/ comment period (81 FR 79863), we did and fringe benefit costs. However, oes292071.htm. not provide an independent estimate of 209 although we did not specify that this http://www.bls.gov/bls/infohome.htm. the burden associated with OAS CAHPS 210 Ibid. estimate included fringe benefit costs, in 211 BLS Occupational Employment Statistics; May Survey based measures for the Hospital previous rules (80 FR 70581), we used 2016. Available at: https://www.bls.gov/oes/current/ $30 to calculate the total cost to oes292071.htm. 212 Ibid.
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OQR Program. Similarly, our finalized measures ((1) OP–1: Median Time to Professional; and (4) OP–21: Median proposal to delay implementation of Fibrinolysis; (2) OP–4: Aspirin at Time to Pain Management for Long these measures does not affect our Arrival; (3) OP–20: Door to Diagnostic Bone Fracture. current burden estimates. Evaluation by a Qualified Medical We calculated the burden reduction Professional; and (4) OP–21: Median associated with the finalized removal of 4. Estimated Burden Due To Proposal to Time to Pain Management for Long two web-based measures (OP–25: Safe Publicly Report OP–18c: Median Time Bone Fracture) and two web-based Surgery Checklist Use and OP–26: From Emergency Department Arrival to measures ((1) OP–25: Safe Surgery Hospital Outpatient Volume Data on Emergency Department Departure for Checklist Use; and (2) OP–26: Hospital Selected Outpatient Surgical Discharged Emergency Department Outpatient Volume Data on Selected Procedures) by considering the time per Patients—Psychiatric/Mental Health Outpatient Surgical Procedures). In measure to report web-based measures Patients total, we expect these finalized as well as the number of participating In section XIII.B.10.b. of this final rule proposals will reduce burden by hospitals. As we previously stated in the with comment period, we are finalizing, 457,490 hours and $16.7 million for the CY 2016 OPPS/ASC final rule with with modifications, our proposal to CY 2020 payment determination. These comment period (80 FR 70582), we publicly report 18c: Median Time from estimates are described in detail below. estimate that hospitals spend Emergency Department Arrival to We calculated the burden reduction approximately 10 minutes per measure Emergency Department Departure for associated with the removal of chart- to report web-based measures and that Discharged Emergency Department abstracted measures by considering the 3,300 outpatient hospitals report data Patients—Psychiatric/Mental Health time per case to report chart-abstracted under the Hospital OQR Program. Patients beginning with patient measures (submitted using a web-based Accordingly, for the CY 2020 payment encounters from the third quarter of tool) as well as the number of cases per determination, we estimate a total 2017. As noted in that section, the data hospital and the number of participating burden reduction of 1,100 hours across required for public reporting of OP–18c hospitals. In the CY 2016 OPPS/ASC 3,300 outpatient hospitals due to the are already collected as part of the final rule with comment period (80 FR removal of two web-based measures (10 existing Hospital OQR Program 70582), we estimated the burden to minutes per measure/60 minutes per × × requirements. Accordingly, we did not collect chart-abstracted data for a single hour 2 measures 3,300 hospitals). estimate changes to burden due to this web-based measure, including OP–21, We further estimate a cost reduction of proposal, and we do not expect the to be 2.92 minutes. In this final rule $40,238 due to this finalized proposal × modifications we are finalizing to affect with comment period, we estimate that (1,100 total hours $36.58 per hour). burden. 3,300 outpatient hospitals report data In total, we expect these finalized under the Hospital OQR Program. Based proposals will reduce burden by 5. Estimated Burden Due to Newly on the most recent data from CY 2015 457,490 hours (456,390 + 1,100) and Finalized Proposals for the CY 2020 reporting, we also estimate that 947 $16,734,984 ($16,694,746 + $40,238) for Payment Determination and Subsequent cases are reported per hospital for each the CY 2020 payment determination. Years chart-abstracted measure. We note that b. Burden Due to Updates to Previously a. Burden Due to Measure Removals although OP–1: Median Time to Finalized Chart-Abstracted Measure Fibrinolysis is a chart-abstracted In section XIII.B.4.c. of this final rule Validation Procedures and the measure, we do not expect removing Educational Review Process with comment period, we are finalizing this measure will reduce burden, as the the removal of six measures from the data collected for this measure is We previously estimated the burden Hospital OQR Program. Specifically, required to calculate another program associated with validation of chart- beginning with the CY 2020 payment measure in the AMI measure set (OP–2: abstracted measures in the CY 2013 and determination, we are finalizing, as Fibrinolytic Therapy Received Within CY 2014 OPPS/ASC final rules with proposed, to remove: (1) OP–21: Median 30 Minutes of ED Arrival) and, comment period (77 FR 68531 and 78 Time to Pain Management for Long therefore, will continue to be collected FR 75172, respectively). In section Bone Fracture; and (2) OP–26: Hospital as an underlying part of OP–2 even XIII.D.7.a. of this final rule with Outpatient Volume Data on Selected though we are finalizing the proposal to comment period, we are providing Outpatient Surgical Procedures. Also, remove OP–1. Accordingly, there is no clarification on our procedures for while we proposed to remove: (1) OP 1: change in burden associated with the validation of chart-abstracted measures Median Time to Fibrinolysis, (2) OP–4: finalized removal of this measure to note that the 50 poorest performing Aspirin at Arrival, (3) OP–20: Door to included in our calculations below. outlier hospitals will be targeted for Diagnostic Evaluation by a Qualified Accordingly, we estimate a total validation. We do not expect this Medical Professional, and (4) OP–25: burden reduction of 138.3 hours per clarification to affect burden because it Safe Surgery Checklist beginning with outpatient hospital due to the removal does not alter the number of hospitals the CY 2021 payment determination, we of chart-abstracted measures (2.92 selected for validation or the are finalizing removal of these measures minutes per measure/60 minutes per requirements for those hospitals that are with modification so that removal hour × 3 measure × 947 cases per selected. begins with the CY 2020 payment hospital). In total, across 3,300 In addition, in section XIII.D.7.c. of determination, one year earlier than outpatient hospitals, we estimate a this final rule with comment period, we proposed. In summary, we are finalizing burden reduction of 456,390 hours are finalizing our proposal to formalize removal of six measures beginning with (138.3 hours per hospital × 3,300 the process of allowing hospitals to use the CY 2020 payment determination. hospitals) and $16,694,746 (456,390 an educational review process to correct We note that we have modified our total hours × $36.58 per hour) for the CY incorrect validation results for the first estimates from the proposed rule (82 FR 2020 payment determination due to the three quarters of validation for chart- 33673) in order to streamline our finalized removal of (1) OP–1: Median abstracted measures. We also are discussion in light of the modification. Time to Fibrinolysis; (2) OP–4: Aspirin finalizing our proposal to update the Specifically, we are finalizing the at Arrival; (3) OP–20: Door to Diagnostic process to specify that if the results of removal of four chart-abstracted Evaluation by a Qualified Medical an educational review indicate that we
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incorrectly scored a hospital’s medical d. Burden Due To Aligning the First In section XIV.B.3.b. of this final rule records selected for validation, the Quarter for Which Hospitals Must with comment period, we are finalizing corrected quarterly validation score will Submit Data for All Hospitals That Did our proposals, beginning with the CY be used to compute the hospital’s final Not Participate in the Previous Year’s 2019 payment determination, to remove validation score at the end of the Hospital OQR Program three measures (ASC–5: Prophylactic calendar year. Under this policy, the In section XIII.D.1 of this final rule Intravenous (IV) Antibiotic Timing, educational review request process with comment period, we are finalizing ASC–6: Safe Surgery Checklist Use, and remains the same for the CY 2020 our proposals to align the timeline ASC–7: Ambulatory Surgical Center payment determination and subsequent specifying the initial quarter for which Facility Volume Data on Selected years, except that revised scores hospitals must submit data for all Ambulatory Surgical Center Surgical Procedures) from the ASCQR Program identified through an educational hospitals that did not participate in the measure set. In section XIV.B.6.a. of this review will be used to correct a previous year’s Hospital OQR Program, rather than specifying different final rule with comment period, we are hospital’s validation score. As a result, not finalizing our proposal, beginning we do not expect this policy to affect the timelines for hospitals with Medicare acceptance dates before versus after with the CY 2021 payment burden experienced by hospitals, as our determination, to adopt one new changes to this policy result in a change January 1 of the year prior to an affected annual payment update. Although this measure, ASC–16: Toxic Anterior in the way we address educational finalized proposal alters the timeline for Segment Syndrome. In section review requests and not a change to the hospitals to begin submitting data for XIV.B.6.b. and c. of this final rule with process hospitals must follow to request the Hospital OQR Program, it does not comment period, we are finalizing our an education review. alter program requirements. As a result, proposals, beginning with the CY 2022 As we stated in the CY 2014 OPPS/ we do not anticipate that this proposal payment determination, to adopt two ASC final rule with comment period (78 will affect burden. new measures collected via claims FR 75171), we believe there is a burden (ASC–17: Hospital Visits after e. Burden Due to Updates to the associated with successful participation Orthopedic Ambulatory Surgical Center Previously Finalized ECE Policy Procedures and ASC–18: Hospital Visits in the Hospital OQR Program, where after Urology Ambulatory Surgical successful participation results in a full We previously estimated the burden associated with general and Center Procedures). We expect these annual payment update (APU) for a finalized proposals will reduce the particular payment determination. This administrative Hospital OQR Program requirements in the CY 2014 OPPS/ASC overall burden of reporting data for the burden includes, but is not limited to, final rule with comment period (78 FR ASCQR Program, as discussed below. maintaining familiarity with the 75171). In section XIII.D.8. of this final In this final rule with comment Hospital OQR Program requirements, rule with comment period, we discuss period, we also are finalizing our which includes checking feedback our finalized alignment of the naming of proposals: (1) To delay ASC–15a–e: reports to indicate a facility’s current this exception policy and finalized OAS CAHPS survey-based measures status or performance (78 FR 75171). proposal to update 42 CFR 419.46(d) to beginning with the CY 2020 payment The overall administrative burden was reflect our current ECE policies. We also determination (CY 2018 data collection) estimated at 42 hours per hospital (78 are clarifying the timing of our response (section XIV.B.4. of this final rule with FR 75171). As stated above, we do not to ECE requests. Because we do not seek comment period); (2) to expand the believe this burden will change with the any new or additional information in CMS online tool to also allow for batch finalization of our policy to update the our finalized ECE proposals, we believe submission beginning with data educational review process to include the updates will have no effect on submitted during CY 2018 and to make corrections because no additional burden for hospitals. corresponding revisions to the CFR activity on the part of hospitals is (section XIV.D.3.b. of this final rule with C. ICRs for the ASCQR Program comment period); and, (3) to align the required. 1. Background naming of the Extraordinary c. Burden Due to Proposal To Update to Circumstances Exceptions (ECE) policy NOP Submission Deadline We refer readers to the CY 2012 beginning with CY 2018 and to make OPPS/ASC final rule with comment conforming changes to the CFR (section We previously estimated the burden period (76 FR 74554), the FY 2013 IPPS/ XIV.D.6.b. of this final rule with associated with Hospital OQR Program LTCH PPS final rule (77 FR 53672), and comment period). As discussed below, participation and requirements in the the CY 2013, CY 2014, CY 2015, CY we do not expect these finalized CY 2014 OPPS/ASC final rule with 2016, and CY 2017 OPPS/ASC final proposals to affect our burden estimates. comment period (78 FR 75171). In rules with comment periods (77 FR 2. Newly Finalized Change in Hourly section XIII.C.2. of this final rule with 68532 through 68533; 78 FR 75172 through 75174; 79 FR 67015 through Labor Cost for Burden Calculation for comment period, we are not finalizing the ASCQR Program our proposal to revise the NOP 67016; 80 FR 70582 through 70584; and submission deadlines such that 81 FR 79863 through 79865, To better align this program with our respectively) for detailed discussions of hospitals are required to submit the other quality reporting and value-based the ASCQR Program information NOP any time prior to registering on the purchasing programs, we are finalizing collection requirements we have our proposal to update our burden QualityNet Web site. We estimated that previously finalized. The information calculation methodology to standardize this proposal would have a negligible collection requirements associated with elements within our burden calculation. effect on the time and cost of the ASCQR Program are currently Specifically, we are finalizing our completing the participation approved under OMB control number proposal to utilize an updated standard requirements. As a result, our decision 0938–1270. Below we discuss only the hourly labor cost for data reporting not to finalize the proposal to revise the changes in burden that will result from activities. NOP submission deadline does not the newly finalized provisions in this In the CY 2017 OPPS/ASC final rule impact our burden estimates. final rule with comment period. with comment period (81 FR 79863
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through 79864), we finalized our our proposal to delay ASC–15a–e: OAS Data for ASC–5 is submitted via CMS proposal to use the hourly labor cost of CAHPS Survey-based measures claims using Quality Data Codes, which $32.84 (hourly wage plus fringe and beginning with the CY 2020 payment impose only a nominal burden on overhead, discussed in more detail determination (CY 2018 data collection) providers because these claims are below) in estimating the labor costs until further notice in future already submitted for the purposes of associated with abstracting clinical data. rulemaking. As described in the CY payment. Therefore, we estimate a This labor rate was based on the Bureau 2017 OPPS/ASC final rule with nominal reduction in burden associated of Labor Statistics (BLS) median hourly comment period (81 FR 79864), the with our finalized proposal to remove wage for a medical records and health information collection requirements the ASC–5 measure from the ASCQR information technician of $16.42 per associated with the five OAS CAHPS Program measure set beginning with the hour.213 The BLS is the principal Survey based measures (ASC–15a, ASC– CY 2019 payment determination. Federal agency responsible for 15b, ASC–15c, ASC–15d, and ASC–15e) We believe 3,937 ASCs will measuring labor market activity, are currently approved under OMB experience a reduction in burden working conditions, and price changes Control Number 0938–1240. For this associated with our finalized proposals in the economy.214 Acting as an reason, we did not provide an to remove ASC–6 and ASC–7 from the independent agency, the BLS provides independent estimate of the burden ASCQR Program measure set. In the CY objective information for not only the associated with OAS CAHPS Survey 2014 OPPS/ASC final rule with government, but also for the public.215 administration for the ASCQR Program comment period (78 FR 75173), we The BLS describes medical records and in the CY 2017 OPPS/ASC final rule finalized our estimates that each health information technicians as those with comment period (81 FR 79864). participating ASC will spend 10 responsible for processing and Similarly, our finalized proposal to minutes per measure per year to collect maintaining health information data.216 delay reporting on these measures does and submit the required data for the Therefore, we believe it is reasonable to not affect our current burden estimates. ASC–6 and ASC–7 measures, making assume that these individuals will be In section XIV.D.3. of this final rule the total estimated annual burden tasked with abstracting clinical data for with comment period, we are finalizing associated with each of these measures ASCQR Program measures. our proposals to expand the CMS online 657 hours (3,937 ASCs × 0.167 hours The BLS recently released updated tool to also allow for batch submission per ASC) and $24,033 (657 hours × wage estimates for Medical Records and beginning with data submitted during $36.58 per hour). Therefore, we estimate Health Information Technicians. These the CY 2018 reporting period and to a total reduction in burden of 1,314 (657 updates increased the median hourly make corresponding revisions to the hours × 2 measures) hours and $48,066 wage from $16.42 per hour to $18.29 per CFR. We expect this finalized proposal (1,314 hours × $36.58 per hour) for all hour.217 Applying the same 100 percent to increase the efficiency of data ASCs as a result of our finalized overhead cost estimate finalized in the submission via the CMS online tool. proposals to remove ASC–6 and ASC– CY 2017 OPPS/ASC final rule with However, the finalized proposal does 7 from the ASCQR Program measure set. comment period (81 FR 79863 through not change our data reporting The reduction in burden associated with 79864) to estimate the elements requirements, and therefore, we do not these requirements is available for assigned as ‘‘indirect’’ or ‘‘overhead’’ expect a change in the burden review and comment under OMB costs, we estimate an updated total experienced by ASCs. Control Number 0938–1270. hourly cost to ASCs of $36.58. In section XIV.D.6. of this final rule 5. Estimated Burden of ASCQR Program Therefore, we proposed to apply an with comment period, we are finalizing for the CY 2021 Payment Determination updated hourly labor cost of $36.58 our proposals to align the naming of the ($18.29 base salary + $18.29 fringe and Extraordinary Circumstances Exceptions In section XIV.B.6.a. of this final rule overhead) to our burden calculations for (ECE) policy beginning with CY 2018 with comment period, we are not chart abstraction. and to make conforming changes to the finalizing our proposal to adopt one We invited public comment on this CFR. We are also clarifying the timing new measure collected via a CMS online proposal. We did not receive any public of our response to ECE requests. data submission tool, ASC–16: Toxic comments and are finalizing our Because we do not seek any new or Anterior Segment Syndrome, beginning proposal to apply an updated hourly additional information in our ECE with the CY 2021 payment labor cost of $36.58 ($18.29 base salary finalized proposals, we believe the determination. Therefore, the initially + $18.29 fringe and overhead) to our updates will have no effect on burden estimated burden from the CY 2018 burden calculations for chart for hospitals. OPPS/ASC proposed rule (82 FR 33709) abstraction. does not apply. 4. Estimated Burden of Newly Finalized 3. Estimated Burden of Newly Finalized ASCQR Program Proposals for the CY 6. Estimated Burden of ASCQR Program ASCQR Program Proposals Beginning 2019 Payment Determination Newly Finalized Proposals for the CY With CY 2018 In section XIV.B.3.b. of this final rule 2022 Payment Determination In section XIV.B.4. of this final rule with comment period, we are finalizing In section XIV.B.6.b. and c. of this with comment period, we are finalizing our proposals, beginning with the CY final rule with comment period, we are 2019 payment determination, to remove finalizing our proposals, beginning with 213 Available at: http://www.bls.gov/ooh/ three measures from the ASCQR the CY 2022 payment determination, to healthcare/medical-records-and-health- Program. These measures include one adopt two measures collected via information-technicians.htm. 214 Available at: http://www.bls.gov/bls/ claims-based measure (ASC–5: claims: (1) ASC–17: Hospital Visits after infohome.htm. Prophylactic Intravenous (IV) Antibiotic Orthopedic Ambulatory Surgical Center 215 Ibid. Timing) and two collected via a CMS Procedures; and (2) ASC–18: Hospital 216 BLS Occupational Employment Statistics; May online data submission tool (ASC–6: Visits after Urology Ambulatory 2016. Available at: https://www.bls.gov/oes/current/ Safe Surgery Checklist Use and ASC–7: Surgical Center Procedures. Data used to oes292071.htm. 217 Available at: https://www.bls.gov/ooh/ Ambulatory Surgical Center Facility calculate scores for these measures is healthcare/medical-records-and-health- Volume Data on Selected Ambulatory collected via Part A and Part B Medicare information-technicians.htm. Surgical Center Surgical Procedures). administrative claims and Medicare
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enrollment data, and therefore does not comment period has been reviewed by finalized in this final rule with require ASCs to report any additional the Office of Management and Budget. comment period, will be approximately data. Because these measures do not We have prepared a regulatory impact $690 million. Taking into account our require ASCs to submit any additional analysis that, to the best of our ability, estimated changes in enrollment, data, we do not believe there will be any presents the costs and benefits of this utilization, and case-mix for CY 2018, additional burden associated with these final rule with comment period. In the we estimate that the OPPS expenditures, proposals. CY 2018 OPPS/ASC proposed rule (82 including beneficiary cost-sharing, for FR 33710), we solicited public CY 2018 will be approximately $69.9 XVII. Response to Comments comments on the regulatory impact billion; approximately $5.8 billion Because of the large number of public analysis in the proposed rule, and we higher than estimated OPPS comments we normally receive on are addressing any public comments we expenditures in CY 2017. Because this Federal Register documents, we are not received in this final rule with comment final rule with comment period is able to acknowledge or respond to them period as appropriate. economically significant as measured by individually. We will consider all the threshold of an additional $100 2. Statement of Need comments we receive by the date and million in expenditures in 1 year, we time specified in the DATES section of This final rule with comment period have prepared this regulatory impact this final rule with comment period, is necessary to make updates to the analysis that, to the best of our ability, and, when we proceed with a Medicare hospital OPPS rates. It is presents its costs and benefits. Table 88 subsequent document(s), we will necessary to make changes to the displays the distributional impact of the respond to those comments in the payment policies and rates for CY 2018 changes in OPPS payment to preamble to that document. outpatient services furnished by various groups of hospitals and for hospitals and CMHCs in CY 2018. We XVIII. Economic Analyses CMHCs. are required under section We estimate that the update to the A. Regulatory Impact Analysis 1833(t)(3)(C)(ii) of the Act to update conversion factor and other adjustments annually the OPPS conversion factor 1. Introduction (not including the effects of outlier used to determine the payment rates for payments, the pass-through estimates, We have examined the impacts of this APCs. We also are required under and the application of the frontier State final rule with comment period, as section 1833(t)(9)(A) of the Act to wage adjustment for CY 2017) will required by Executive Order 12866 on review, not less often than annually, increase total OPPS payments by 1.3 Regulatory Planning and Review and revise the groups, the relative percent in CY 2018. The changes to the (September 30, 1993), Executive Order payment weights, and the wage and APC relative payment weights, the 13563 on Improving Regulation and other adjustments described in section changes to the wage indexes, the Regulatory Review (January 18, 2011), 1833(t)(2) of the Act. We must review continuation of a payment adjustment the Regulatory Flexibility Act (RFA) the clinical integrity of payment groups for rural SCHs, including EACHs, and (September 19, 1980, Pub. L. 96–354), and relative payment weights at least the payment adjustment for cancer section 1102(b) of the Social Security annually. We are revising the APC hospitals will not increase OPPS Act, section 202 of the Unfunded relative payment weights using claims payments because these changes to the Mandates Reform Act of 1995 (UMRA) data for services furnished on and after OPPS are budget neutral. However, (March 22, 1995, Pub. L. 104–4), January 1, 2016, through and including these updates will change the Executive Order 13132 on Federalism December 31, 2016, and processed distribution of payments within the (August 4, 1999), the Congressional through June 30, 2017, and updated cost budget neutral system. We estimate that Review Act (5 U.S.C. 804(2)), and report information. the total change in payments between Executive Order 13771 on Reducing This final rule with comment period CY 2017 and CY 2018, considering all Regulation and Controlling Regulatory also is necessary to make updates to the payments, changes in estimated total Costs (January 30, 2017). This section of ASC payment rates for CY 2018, outlier payments, pass-through this final rule with comment period enabling CMS to make changes to payments, and the application of the contains the impact and other economic payment policies and payment rates for frontier State wage adjustment outside analyses for the provisions that we are covered surgical procedures and of budget neutrality, in addition to the making for CY 2018. covered ancillary services that are application of the OPD fee schedule Executive Orders 12866 and 13563 performed in an ASC in CY 2018. increase factor after all adjustments direct agencies to assess all costs and Because ASC payment rates are based required by sections 1833(t)(3)(F), benefits of available regulatory on the OPPS relative payment weights 1833(t)(3)(G), and 1833(t)(17) of the Act, alternatives and, if regulation is for the majority of the procedures will increase total estimated OPPS necessary, to select regulatory performed in ASCs, the ASC payment payments by 1.4 percent. approaches that maximize net benefits rates are updated annually to reflect We estimate the total increase (from (including potential economic, annual changes to the OPPS relative changes to the ASC provisions in this environmental, public health and safety payment weights. In addition, we are final rule with comment period as well effects, distributive impacts, and required under section 1833(i)(1) of the as from enrollment, utilization, and equity). Executive Order 13563 Act to review and update the list of case-mix changes) in Medicare emphasizes the importance of surgical procedures that can be expenditures under the ASC payment quantifying both costs and benefits, of performed in an ASC not less frequently system for CY 2018 compared to CY reducing costs, of harmonizing rules, than every 2 years. 2017 to be approximately $130 million. and of promoting flexibility. This final Because the provisions for the ASC rule with comment period has been 3. Overall Impacts for the OPPS and payment system are part of a final rule designated as an economically ASC Payment Provisions that is economically significant as significant rule under section 3(f)(1) of We estimate that the total increase in measured by the $100 million threshold, Executive Order 12866 and a major rule Federal government expenditures under we have prepared a regulatory impact under the Congressional Review Act. the OPPS for CY 2018, compared to CY analysis of the changes to the ASC Accordingly, this final rule with 2017, due only to the changes to OPPS payment system that, to the best of our
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ability, presents the costs and benefits of regulation is $2,851,939 ($841.28 × participating hospitals through the 340B this portion of this final rule with 3,390 reviewers). Program. Rural SCHs, children’s comment period. Table 89 and 90 of this hospitals, and PPS-exempt cancer 5. Detailed Economic Analyses final rule with comment period display hospitals are excepted from this the redistributive impact of the CY 2018 a. Estimated Effects of OPPS Changes in payment policy in CY 2018. changes regarding ASC payments, This Final Rule With Comment Period Specifically, in this final rule with grouped by specialty area and then (1) Limitations of Our Analysis comment period, for CY 2018, for grouped by procedures with the greatest hospitals paid under the OPPS (other ASC expenditures, respectively. The distributional impacts presented than those that are excepted for CY here are the projected effects of the CY 2018), we are paying for separately 4. Regulatory Review Costs 2018 policy changes on various hospital payable drugs and biologicals that are If regulations impose administrative groups. We post on the CMS Web site obtained with a 340B discount, costs on private entities, such as the our hospital-specific estimated excluding those on pass-through time needed to read and interpret this payments for CY 2018 with the other payment status and vaccines, at ASP final rule with comment period, we supporting documentation for this final minus 22.5 percent instead of ASP+6 should estimate the cost associated with rule with comment period. To view the percent. For context, based on CY 2016 regulatory review. Due to the hospital-specific estimates, we refer claims data, the total OPPS Part B drug uncertainty involved with accurately readers to the CMS Web site at: http:// payment is approximately $10.2 billion. quantifying the number of entities that www.cms.gov/Medicare/Medicare-Fee- for-Service-Payment/ We recognize that it may be difficult will review the rule, we assume that the to determine precisely what the impact total number of unique commenters on HospitalOutpatientPPS/index.html. At the Web site, select ‘‘regulations and on Medicare spending will be because this year’s proposed rule will be the OPPS claims data do not currently number of reviewers of this final rule notices’’ from the left side of the page and then select ‘‘CMS–1678–FC’’ from indicate if the drug being provided was with comment period. We acknowledge purchased with a 340B discount. that this assumption may understate or the list of regulations and notices. The hospital-specific file layout and the Furthermore, a list of outpatient drugs overstate the costs of reviewing this covered under the 340B program is not rule. It is possible that not all hospital-specific file are listed with the other supporting documentation for this publicly available. Accordingly, for commenters reviewed this year’s purposes of estimating the impact for proposed rule in detail, and it is also final rule with comment period. We show hospital-specific data only for this final rule with comment period, as possible that some reviewers chose not we did in the CY 2018 OPPS/ASC to comment on the proposed rule. For hospitals whose claims were used for modeling the impacts shown in Table proposed rule, we assumed that all these reasons, we believe that the applicable drugs purchased by hospitals number of past commenters would be a 88 below. We do not show hospital- specific impacts for hospitals whose eligible to participate in the 340B fair estimate of the number of reviewers Program were purchased at a discounted of this final rule with comment period. claims we were unable to use. We refer readers to section II.A. of this final rule price under the 340B program. While In the CY 2018 OPPS/ASC proposed we recognize that certain newly covered rule (82 FR 33711), we welcomed any with comment period for a discussion of the hospitals whose claims we do not entities do not have access to 340B drug comments on the approach in pricing for designated orphan drugs, we estimating the number of entities that use for ratesetting and impact purposes. We estimate the effects of the believe that our CY 2018 policy to will review the proposed rule. However, individual policy changes by estimating except newly covered entity types such we did not receive any comments on payments per service, while holding all as rural SCHs, PPS-exempt cancer our approach. other payment policies constant. We use hospitals, and children’s hospitals, We also recognize that different types the best data available, but do not largely mitigates the 340B drug spend of entities are in many cases affected by attempt to predict behavioral responses attributable to orphan drugs and mutually exclusive sections of this final to our policy changes. In addition, we therefore does not dramatically affect rule with comment period, and have not made adjustments for future our final estimate. In addition, for this therefore for the purposes of our changes in variables such as service final rule with comment period, we estimate, we assume that each reviewer volume, service-mix, or number of utilized the HRSA covered entity reads approximately 50 percent of the encounters. database to identify 340B participating rule. In the CY 2018 OPPS/ASC In the CY 2018 OPPS/ASC proposed hospitals and cross-checked these proposed rule, we also sought public rule, we solicited public comment and providers with the CY 2018 OPPS comments on this assumption, but we information about the anticipated effects facility impact public use file to did not receive any comments. of the proposed changes included in the determine which 340B hospitals are Using the wage information from the proposed rule on providers and our paid under the OPPS. The HRSA BLS for medical and health service methodology for estimating them. Any covered entity database is available via managers (Code 11–9111), we estimate public comments that we receive are the Internet at https://340bopais.hrsa. that the cost of reviewing this rule is addressed in the applicable sections of gov/coveredentitysearch. Using this $105.16 per hour, including overhead this final rule with comment period that database, we found 1,338 OPPS and fringe benefits (https://www.bls.gov/ discuss the specific policies. hospitals in the 340B program oes/2016/may/naics4_621100.htm). (compared to the 954 estimated for the Assuming an average reading speed, we (2) Estimated Effects of OPPS Changes proposed rule). Of these, 270 were rural estimate that it will take approximately to Part B Drug Payment on 340B Eligible SCHs, 47 were children’s hospitals, and 8 hours for the staff to review half of Hospitals Paid Under the OPPS 3 were PPS-exempt cancer hospitals. We this final rule with comment period. For In section V.B.7. of this final rule with did not assume changes in the quantity each facility that reviews the rule, the comment period, we discuss our of 340B purchased drugs provided by estimated cost is $841.28 (8 hours × finalized policies to reduce the payment hospitals participating in the 340B $105.16). Therefore, we estimate that for nonpass-through, separately payable program (thereby affecting unit volume) the total cost of reviewing this drugs purchased by certain 340B- or changes in the number of hospitals
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participating in the 340B program that for separately payable drugs purchased of the Act, and that the budget neutral may occur due to the payment through the 340B Program will increase weight scalar would not be applied in reduction. payment rates for other non-drug items determining payments for these While we acknowledge that there are and services paid under the OPPS by an separately paid drugs and biologicals some limitations in Medicare’s ability to offsetting aggregate amount. purchased under the 340B Program. prospectively calculate a precise Because data on drugs that are In addition, we solicited public estimate for purposes of this final rule purchased with a 340B discount are not comment on whether we should apply with comment period, we note that each publicly available, we do not believe it all or part of the savings generated by hospital has the ability to calculate how is possible to more accurately estimate this payment reduction to increase this policy will change its Medicare the amount of the aggregate payment payments for specific services paid payments for separately payable drugs reduction and the offsetting amount of under the OPPS, or under Part B in CY 2018. Specifically, each hospital the adjustment that is necessary to generally, in CY 2018, rather than that is not participating in the 340B ensure budget neutrality through higher simply increasing the conversion factor. program or that is excepted from the payment rates for other services. In particular, we sought public policy to pay for drugs acquired under Furthermore, there are potential comment on whether and how the the 340B Program at ASP minus 22.5 offsetting factors, including possible offsetting increase could be targeted to percent in CY 2018 will know that its changes in provider behavior and hospitals that treat a large share of Medicare payments for drugs will be overall market changes that would indigent patients, especially those unaffected by this finalized policy; likely lower the impact of the payment patients who are uninsured. Finally, we whereas each hospital participating in reduction. As a result, we may need to sought public comment on whether the the 340B Program has access to 340B make an adjustment in future years to redistribution of savings associated with ceiling prices (and subceiling prices if it revise the conversion factor once we the proposal would result in participates in the Prime Vendor have received more accurate data on unnecessary increases in the volume of Program), knows the volume of 340B drugs purchased with a 340B discount covered services paid under the OPPS drugs that it has historically billed to within the OPPS, similar to the that should be adjusted in accordance Medicare, and can generally project the adjustment we made for clinical with section 1833(t)(2)(F) of the Act. specific covered 340B drugs (and diagnostic laboratory test packaging Comment: Several commenters stated volume thereof) for which it expects to policy in the CY 2016 OPPS/ASC final that if the 340B drug payment policy bill Medicare in CY 2018. Accordingly, rule with comment period (80 FR 70352 was finalized, the funds should be a hospital participating in the 340B through 70357). redistributed across the OPPS, as has Program is able to estimate the In this final rule, we project that been the case for the application of difference in payment that it will reducing payment for 340B drugs to budget neutrality in the past. One receive if Medicare pays ASP minus ASP minus 22.5 percent will increase commenter supported CMS’ proposal to 22.5 percent instead of ASP+6 percent OPPS payment rates for non-drug items implement the savings attributed to the for 340B drugs. and services by approximately 3.2 340B payment reduction in a budget Using the list of participating 340B percent in CY 2018. The estimated neutral manner within the OPPS. providers (derived from the HRSA impacts of this policy are displayed in Commenters noted that the budget database) and updated CY 2016 claims Table 88 below. We note that the neutrality requirement upon which data available for this final rule with payment rates included in Addendum A CMS relied in the proposed rule at comment period for the applicable and Addendum B of this final rule with section 1833(t)(9)(B) of the Act has separately payable drugs and comment period do not reflect the historically been interpreted by CMS as biologicals, excluding those on pass- reduced payments for drugs purchased requiring budget neutrality within the through payment status and vaccines, under the 340B Program; however, they OPPS. Commenters strongly urged CMS billed by hospitals eligible to participate do include the increase to payments to follow its longstanding interpretation in the 340B Program, except for those rates for non-drug items and services of section 1833(t)(9)(B) of the Act and hospital types that are excepted from due to the corresponding increase in the offset the full amount of the aggregate this policy in CY 2018, we estimate that conversion factor. In the proposed rule 340B payment reduction through OPPS payments for separately payable (82 FR 33712), we reminded offsetting payment increases within the drugs, including beneficiary commenters that this estimate could OPPS. copayments, will decrease by change in the final rule based on a MedPAC reiterated its March 2016 approximately $1.6 billion under this number of factors, including other recommendation that that payments be finalized policy, which reflects an policies that are adopted in the final distributed in proportion to the amount additional estimated reduction of $700 rule and the availability of updated data of uncompensated care that hospitals million over the proposed rule estimate and/or method of assessing the impact provide, ‘‘to make sure that dollars in of $900 million. If PPS-exempt cancer in the final rule. We sought public the uncompensated care pool actually hospitals, children’s hospitals, and rural comment on our estimate and stated go to the hospitals providing the most SCHs had not been excluded from the that we were especially interested in uncompensated care.’’ MedPAC reduced drug payment in CY 2018, drug whether commenters believe there are commented that the 340B Program is payments to PPS-exempt cancer other publicly available data sources or not well targeted to hospitals that hospitals would have been reduced by proxies that can be used for determining provide high levels of uncompensated approximately $29 million, to children’s which drugs billed by hospitals paid care and noted that 40 percent of 340B hospitals by approximately $2 million, under the OPPS were acquired under hospitals provide less than the median and to rural SCHs by approximately the 340B Program. level of uncompensated care. MedPAC $199 million—this would have resulted We proposed that the reduced stated that it believed that legislation in a total savings estimate of payments for separately payable drugs would be needed to direct the savings approximately $1.8 billion. Because we and biologicals purchased under the to the uncompensated care pool because are implementing this payment 340B Program would be included in the current law would require that the reduction in a budget neutral manner budget neutrality adjustments, under savings be retained within the OPPS to within the OPPS, the reduced payments the requirements in section 1833(t)(9)(B) make it budget neutral. However,
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MedPAC encouraged CMS to request $86 million to rural hospitals. We are payment for 340B-acquired drugs and that Congress enact the legislation redistributing the savings from this biologicals by increasing the conversion necessary to allow CMS to implement payment reduction in a budget neutral factor, and we are not targeting the its recommendation. MedPAC further manner within the OPPS through an savings to specific services paid under noted that legislation would also allow offsetting increase in the conversion the OPPS or under Part B generally. We CMS to apply the policy to all factor. This increase to the conversion continue to be interested in exploring separately payable drugs, including factor increases all OPPS non-drug ways that funds from a subsequent those that are separately payable as a payment rates to all providers under the proposal could be targeted in future result of their pass-through status. OPPS by 3.2 percent. With respect to years to hospitals that serve a high share Response: We thank the commenters comments on the redistribution of the of low-income or uninsured patients. for their feedback. After consideration of 340B savings to non-340B participating Comment: Many commenters noted the public comments we received, we hospitals, we note that 340B hospitals that CMS’ proposal to redistribute the are finalizing our proposal to fully will also receive the conversion factor savings that result from the 340B redistribute the savings associated with increase. reduction in a budget neutral manner adoption of the alternative payment Comment: In response to the within the OPPS would increase methodology for drugs acquired under comment solicitation on whether the beneficiary copayments on non-drug the 340B Program within the OPPS to savings generated by the reduced services. Accordingly, the commenters non-drug items and services. That is, we payment on 340B drugs should be used stated that most patients would not will redistribute $1.6 billion dollars in to increase payments for specific directly receive the benefit of the 340B estimated lower payment for OPPS services paid under the OPPS or under copayment reduction even if reduced drugs by increasing the conversion Part B generally in CY 2018, payments for 340B drugs lower factor for all OPPS non-drug items and commenters generally objected to the coinsurance amounts for these drugs. services by 3.2 percent. We may revisit notion that CMS has authority to The commenters stated the proposal how the funds should be targeted in the redistribute savings outside of OPPS. will likely increase costs for uninsured future. One commenter stated that CMS did not patients because 340B hospitals provide Comment: Some commenters provide any analysis or justification to a disproportionate amount of care to challenged the accuracy of the $900 support a reading that section that population and participating 340B million estimate CMS calculated in the 1833(t)(9)(B) of the Act establishes a hospitals may no longer be able to proposed rule. According to these budget neutrality concept for the provide ‘‘discounts to low-income commenters, their analysis of the Medicare Part B Trust Fund. Another patients’’ or other uncompensated care. proposal would have an estimated commenter stated that CMS should not One commenter suggested that CMS, impact in the range of $1.2 billion to redistribute the savings gained by the with stakeholder input, develop an $1.65 billion. As a result, these 340B proposal based on Medicare DSH outpatient hospital charity care metric commenters asserted that if the metrics (that is, insured low-income that could be used to redistribute the proposed payment reductions are days) because such metrics are not well 340B savings based on the level of applied in a budget neutral manner correlated with uncompensated care outpatient charity care provided by the within the OPPS through an offsetting costs. This commenter also expressed hospital. increase in the conversion factor, their concern regarding the suitability of Response: We appreciate the analysis showed that payments for non- using uncompensated care as a metric stakeholders’ concerns. We believe that drug APCs would increase across ‘‘to identify hospitals that provide the reducing payments on 340B purchased hospitals by about 3.7 percent (in most help to needy patients because it drugs to better align with hospital contrast to CMS’s estimate of 1.4 includes bad debt as well as charity acquisition costs directly lowers drug percent) based on the proposed rule care.’’ The commenter stated that bad costs for those beneficiaries who receive data. Moreover, based on their analysis, debt is the amount that hospitals billed a covered outpatient drug from a 340B the commenters believed the but did not collect, and therefore is not participating hospital. Further, to the redistribution of the savings would a measure of hospital assistance to the extent that studies have found that 340B result in a net decrease in payments to poor. Several commenters challenged participating hospitals tend to use more 340B hospitals of approximately 2.6 the logic of reducing 340B payments to high costs drugs, we believe that this percent, or approximately $800 participating 340B hospitals, only to 340B payment policy helps address million—funding that they stated was return the savings to the very same drug pricing in the hospital outpatient intended to support the congressionally- hospitals. setting by lessening the incentive for mandated mission of 340B hospitals— Response: We appreciate the unnecessary utilization of costly drugs. not be redistributed to other hospitals feedback. Because the OPPS is a budget In addition, even though many that do not participate in the 340B neutral payment system, historically beneficiaries have supplemental Program. CMS has maintained budget neutrality coverage, those plans make coinsurance Response: We stated in the proposed through offsetting estimated payment payments on behalf of beneficiaries. rule that the estimate of the 340B decreases/increases within the OPPS, Thus, to the extent this policy lessens payment reductions would likely such as by increasing/decreasing the the coinsurance amount such change in the final rule based on conversion factor by an equal offsetting supplemental plans would have to updated data, revised assumptions, and amount. We have articulated the policy make, we would expect the price of final policies. For this final rule with justification for reducing drug payment such plans could decrease or otherwise comment period, as discussed in detail to ASP minus 22.5 percent for 340B- reflect these lower costs in the future. earlier, we used updated CY 2016 acquired drugs in section V.B.7. of this In summary, to maintain budget claims data and an updated list of 340B final rule with comment period and are neutrality within the OPPS, the eligible providers to calculate an redistributing the resulting dollars estimated $1.6 billion in reduced drug estimated impact of $1.6 billion based within the OPPS to maintain budget payments from adoption of this final on the final policy. As shown in Table neutrality for CY 2018. Therefore, we 340B payment methodology will be 88 below this reflects a reduction of are finalizing our proposal to redistributed in an equal offsetting about $1.5 billion to urban hospitals and redistribute the estimated reduction in amount to all hospitals paid under the
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OPPS through increasing the payment factor of 1.35 percent in the calculation In CY 2016, we excluded all rates by 3.2 percent for nondrug items of the CY 2018 OPPS conversion factor. molecular pathology laboratory tests and services furnished by all hospitals Section 10324 of the Affordable Care from our packaging policy, and in CY paid under the OPPS for CY 2018. Act, as amended by HCERA, further 2017, we expanded the laboratory authorized additional expenditures packaging exception to apply to all (3) Estimated Effects of OPPS Changes outside budget neutrality for hospitals advanced diagnostic laboratory tests on Hospitals in certain frontier States that have a (ADLTs) that meet the criteria of section Table 88 below shows the estimated wage index less than 1.0000. The 1834A(d)(5)(A) of the Act. For CY 2018, impact of this final rule with comment amounts attributable to this frontier we sought public comments on whether period on hospitals. Historically, the State wage index adjustment are laboratories (instead of hospitals) first line of the impact table, which incorporated in the CY 2018 estimates should be permitted to bill Medicare estimates the change in payments to all in Table 88. directly for molecular pathology tests facilities, has always included cancer To illustrate the impact of the CY and ADLTs that meet the criteria of and children’s hospitals, which are held 2018 changes, our analysis begins with section 1834A(d)(5)(A) of the Act (and harmless to their pre-BBA amount. We a baseline simulation model that uses are granted ADLT status by CMS), that also include CMHCs in the first line that the CY 2017 relative payment weights, are ordered less than 14 days following includes all providers. We now include the FY 2017 final IPPS wage indexes the date of a hospital outpatient’s a second line for all hospitals, excluding that include reclassifications, and the discharge from the hospital outpatient permanently held harmless hospitals final CY 2017 conversion factor. Table department. and CMHCs. 88 shows the estimated redistribution of The laboratory date of service (DOS) We present separate impacts for the increase or decrease in payments for issue is discussed in section X.F. of this CMHCs in Table 88, and we discuss CY 2018 over CY 2017 payments to final rule with comment period. them separately below, because CMHCs hospitals and CMHCs as a result of the Because there are currently no are paid only for partial hospitalization following factors: The impact of the laboratory tests designated as ADLTs services under the OPPS and are a APC reconfiguration and recalibration and because the payment rate for different provider type from hospitals. changes between CY 2017 and CY 2018 laboratory tests excluded from our In CY 2018, we are paying CMHCs for (Column 2); the wage indexes and the packaging policy billed by a hospital partial hospitalization services under provider adjustments (Column 3); the would have been the applicable rate for APC 5853 (Partial Hospitalization for combined impact of all of the changes the laboratory test under the CLFS, any CMHCs), and we are paying hospitals described in the preceding columns aspect of this discussion that is finalized for partial hospitalization services under plus the 1.35 percent OPD fee schedule in this final rule with comment period APC 5863 (Partial Hospitalization for increase factor update to the conversion will not result in a net costs or savings Hospital-Based PHPs). factor; and the estimated impact taking to the program. Accordingly, section The estimated increase in the total into account all payments for CY 2018 X.F. of this final rule with comment payments made under the OPPS is relative to all payments for CY 2017, period is not included in the impact determined largely by the increase to including the impact of changes in table in the regulatory impact analysis. the conversion factor under the estimated outlier payments, the frontier Overall, we estimate that the rates for statutory methodology. The State wage adjustment, and changes to CY 2018 will increase Medicare OPPS distributional impacts presented do not the pass-through payment estimate payments by an estimated 1.4 percent. include assumptions about changes in (Column 6). Removing payments to cancer and volume and service-mix. The We did not model an explicit budget children’s hospitals because their conversion factor is updated annually neutrality adjustment for the rural payments are held harmless to the pre- by the OPD fee schedule increase factor adjustment for SCHs because we are OPPS ratio between payment and cost as discussed in detail in section II.B. of maintaining the current adjustment and removing payments to CMHCs this final rule with comment period. percentage for CY 2018. Because the results in an estimated 1.5 percent Section 1833(t)(3)(C)(iv) of the Act updates to the conversion factor increase in Medicare payments to all provides that the OPD fee schedule (including the update of the OPD fee other hospitals. These estimated increase factor is equal to the market schedule increase factor), the estimated payments will not significantly impact basket percentage increase applicable cost of the rural adjustment, and the other providers. under section 1886(b)(3)(B)(iii) of the estimated cost of projected pass-through Column 1: Total Number of Hospitals Act, which we refer to as the IPPS payment for CY 2018 are applied market basket percentage increase. The uniformly across services, observed The first line in Column 1 in Table 88 IPPS market basket percentage increase redistributions of payments in the shows the total number of facilities for FY 2018 is 2.7 percent (82 FR impact table for hospitals largely (3,878), including designated cancer and 38177). Section 1833(t)(3)(F)(i) of the depend on the mix of services furnished children’s hospitals and CMHCs, for Act reduces that 2.7 percent by the by a hospital (for example, how the which we were able to use CY 2016 multifactor productivity adjustment APCs for the hospital’s most frequently hospital outpatient and CMHC claims described in section 1886(b)(3)(B)(xi)(II) furnished services will change), and the data to model CY 2017 and CY 2018 of the Act, which is 0.6 percentage point impact of the wage index changes on the payments, by classes of hospitals, for for FY 2018 (which is also the MFP hospital. However, total payments made CMHCs and for dedicated cancer adjustment for FY 2018 in the FY 2018 under this system and the extent to hospitals. We excluded all hospitals and IPPS/LTCH PPS final rule (82 FR 38177 which this final rule with comment CMHCs for which we could not through 38178)), and sections period will redistribute money during plausibly estimate CY 2017 or CY 2018 1833(t)(3)(F)(ii) and 1833(t)(3)(G)(v) of implementation also will depend on payment and entities that are not paid the Act further reduce the market basket changes in volume, practice patterns, under the OPPS. The latter entities percentage increase by 0.75 percentage and the mix of services billed between include CAHs, all-inclusive hospitals, point, resulting in the OPD fee schedule CY 2017 and CY 2018 by various groups and hospitals located in Guam, the U.S. increase factor of 1.35 percent. We are of hospitals, which CMS cannot Virgin Islands, Northern Mariana using the OPD fee schedule increase forecast. Islands, American Samoa, and the State
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of Maryland. This process is discussed Column 3 reflects the independent Column 5: All Budget Neutrality in greater detail in section II.A. of this effects of the updated wage indexes, Changes Combined With the Market final rule with comment period. At this including the application of budget Basket Update time, we are unable to calculate a DSH neutrality for the rural floor policy on a Column 5 demonstrates the combined variable for hospitals that are not also nationwide basis. This column excludes impact of all of the changes previously paid under the IPPS because DSH the effects of the frontier State wage described and the update to the payments are only made to hospitals index adjustment, which is not budget conversion factor of 1.35 percent. paid under the IPPS. Hospitals for neutral and is included in Column 6. Overall, these changes will increase which we do not have a DSH variable We did not model a budget neutrality payments to urban hospitals by 1.2 are grouped separately and generally adjustment for the rural adjustment for percent and to rural hospitals by 2.5 include freestanding psychiatric SCHs because we are continuing the percent. Urban hospitals will receive an hospitals, rehabilitation hospitals, and rural payment adjustment of 7.1 percent increase in line with the 1.3 percent long-term care hospitals. We show the to rural SCHs for CY 2018, as described overall increase for all facilities after the total number of OPPS hospitals (3,765), in section II.E. of this final rule with update is applied to the proposed excluding the hold-harmless cancer and comment period. budget neutrality adjustments. The children’s hospitals and CMHCs, on the increase for classes of rural hospitals is second line of the table. We excluded We modeled the independent effect of more variable with sole community cancer and children’s hospitals because updating the wage indexes by varying hospitals receiving a 3.9 percent section 1833(t)(7)(D) of the Act only the wage indexes, holding APC increase and other rural hospitals permanently holds harmless cancer relative payment weights, service-mix, receiving an increase of 0.8 percent. hospitals and children’s hospitals to and the rural adjustment constant and their ‘‘pre-BBA amount’’ as specified using the CY 2018 scaled weights and Column 6: All Changes for CY 2018 under the terms of the statute, and a CY 2017 conversion factor that Column 6 depicts the full impact of therefore, we removed them from our included a budget neutrality adjustment the CY 2018 policies on each hospital impact analyses. We show the isolated for the effect of the changes to the wage group by including the effect of all of impact on the 49 CMHCs at the bottom indexes between CY 2017 and CY 2018. the changes for CY 2018 and comparing of the impact table and discuss that The FY 2018 wage policy results in them to all estimated payments in CY impact separately below. modest redistributions. 2017. Column 6 shows the combined Column 2: APC Recalibration—All There is a slight increase of less than budget neutral effects of Columns 2 Changes 0.1 in Column 3 for the CY 2018 cancer through 4; the OPD fee schedule Column 2 shows the estimated effect hospital payment adjustment budget increase; the impact of the frontier State of APC recalibration. Column 2 also neutrality calculation because we are wage index adjustment; the impact of reflects any changes in multiple using a payment-to-cost ratio target for estimated OPPS outlier payments as procedure discount patterns or the cancer hospital payment adjustment discussed in section II.G. of this final conditional packaging that occur as a in CY 2018 of 0.88, compared to the CY rule with comment period; the change result of the changes in the relative 2017 OPPS/ASC final rule with in the Hospital OQR Program payment magnitude of payment weights. As a comment period (81 FR 79869) reduction for the small number of result of APC recalibration, we estimate payment-to-cost ratio target of 0.91. We hospitals in our impact model that that urban hospitals will experience an note that, in accordance with section failed to meet the reporting increase of 0.1 percent, with the impact 16002 of the 21st Century Cures Act, we requirements (discussed in section XIII. ranging from an increase of 0.1 percent are applying a budget neutrality factor of this final rule with comment period); to no change, depending on the number calculated as if the cancer hospital and the difference in total OPPS of beds. Rural hospitals will experience adjustment target payment-to-cost ratio payments dedicated to transitional pass- a decrease of 0.3 percent, with the was 0.89, not the 0.88 target payment- through payments. impact ranging from a decrease of 0.2 to-cost ratio we are applying in section Of those hospitals that failed to meet percent to a decrease of 0.5 percent, II.F. of this final rule with comment the Hospital OQR Program reporting depending on the number of beds. Major period. requirements for the full CY 2017 teaching hospitals will experience an update (and assumed, for modeling increase of 0.1 percent. Column 4: Effect of the Reduced purposes, to be the same number for CY Payment for 340B Drugs 2018), we included 33 hospitals in our Column 3: Wage Indexes and the Effect model because they had both CY 2016 of the Provider Adjustments Column 4 demonstrates the total claims data and recent cost report data. Column 3 demonstrates the combined payment effect of the finalized We estimate that the cumulative effect budget neutral impact of the APC reduction in payment for drugs of all of the changes for CY 2018 will recalibration; the updates for the wage purchased under the 340B Program from increase payments to all facilities by 1.4 indexes with the FY 2018 IPPS post- ASP+6 percent to ASP minus 22.5 percent for CY 2018. We modeled the reclassification wage indexes; the rural percent. This column includes both the independent effect of all of the changes adjustment; and the cancer hospital reduced payment for 340B acquired in Column 6 using the final relative payment adjustment. We modeled the drugs and the increase to the conversion payment weights for CY 2017 and the independent effect of the budget factor for budget neutrality purposes, final relative payment weights for CY neutrality adjustments and the OPD fee which increases payment for all non- 2018. We used the final conversion schedule increase factor by using the drug services. For rural sole community factor for CY 2017 of $75.001 and the relative payment weights and wage hospitals, this column shows a 2.6 final CY 2018 conversion factor of indexes for each year, and using a CY percent increase, reflecting a 0.0 percent $78.636 discussed in section II.B. of this 2017 conversion factor that included the increase for drugs (because these final rule with comment period. OPD fee schedule increase and a budget providers are exempt from these Column 6 contains simulated outlier neutrality adjustment for differences in reductions) and a 3.2 percent increase payments for each year. We used the 1- wage indexes. for non-drug services. year charge inflation factor used in the
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FY 2018 IPPS/LTCH PPS final rule (82 to model the CY 2018 outliers at 1.0 payments to urban hospitals by 1.3 FR 38527) of 4.6 percent (1.04574) to percent of estimated total payments percent. Overall, we estimate that rural increase individual costs on the CY using a multiple threshold of 1.75 and hospitals will experience a 2.7 percent 2016 claims, and we used the most a fixed-dollar threshold of $4,150. The increase as a result of the combined recent overall CCR in the July 2017 charge inflation and CCR inflation effects of all of the changes for CY 2018. Outpatient Provider-Specific File factors are discussed in detail in the FY Among hospitals by teaching status, (OPSF) to estimate outlier payments for 2018 IPPS/LTCH PPS final rule (82 FR we estimate that the impacts resulting CY 2017. Using the CY 2016 claims and 38527). from the combined effects of all changes Overall, we estimate that facilities a 4.6 percent charge inflation factor, we will include a decrease of 0.9 percent will experience an increase of 1.4 currently estimate that outlier payments for major teaching hospitals and an percent under this final rule with for CY 2017, using a multiple threshold comment period in CY 2018 relative to increase of 2.9 percent for nonteaching of 1.75 and a fixed-dollar threshold of total spending in CY 2017. This hospitals. Minor teaching hospitals will $3,825 will be approximately 1.11 projected increase (shown in Column 6) experience an estimated increase of 1.7 percent of total payments. The of Table 88 reflects the 1.35 percent percent. estimated current outlier payments of OPD fee schedule increase factor, plus In our analysis, we also have 1.11 percent are incorporated in the 0.2 percent for the change in the pass- categorized hospitals by type of comparison in Column 6. We used the through estimate between CY 2017 and ownership. Based on this analysis, we same set of claims and a charge inflation CY 2018, minus a decrease of 0.11 estimate that voluntary hospitals will factor of 9.4 percent (1.09357) and the percent for the difference in estimated experience an increase of 1.3 percent, CCRs in the July 2017 OPSF, with an outlier payments between CY 2017 (1.11 proprietary hospitals will experience an adjustment of 0.985569, to reflect percent) and CY 2018 (1.0 percent). We increase of 4.5 percent, and relative changes in cost and charge estimate that the combined effect of all governmental hospitals will experience inflation between CY 2016 and CY 2018, of the changes for CY 2018 will increase no change.
TABLE 88—ESTIMATED IMPACT OF THE CY 2018 CHANGES FOR THE HOSPITAL OUTPATIENT PROSPECTIVE PAYMENT SYSTEM
All budget neutral APC New wage changes Number of recalibration index and 340B (combined hospitals (all provider adjustment cols 2–4) All changes changes) adjustments with market basket update
(1) (2) (3) (4) (5) (6)
ALL FACILITIES * ...... 3,878 0.0 0.0 0.0 1.3 1.4 ALL HOSPITALS (excludes hospitals permanently held harmless and CMHCs) ...... 3,765 0.0 0.1 ¥0.1 1.4 1.5 URBAN HOSPITALS: 2,951 0.1 0.1 ¥0.3 1.2 1.3 LARGE URBAN (GT 1 MILL.) ...... 1,589 0.1 0.0 ¥0.2 1.2 1.3 OTHER URBAN (LE 1 MILL.) ...... 1,362 0.0 0.2 ¥0.3 1.3 1.4 RURAL HOSPITALS: 814 ¥0.3 0.0 1.4 2.5 2.7 SOLE COMMUNITY ...... 372 ¥0.2 0.1 2.6 3.9 4.1 OTHER RURAL ...... 442 ¥0.4 ¥0.2 0.0 0.8 0.9 BEDS (URBAN): 0–99 BEDS ...... 1,021 0.0 0.0 1.9 3.3 3.4 100–199 BEDS ...... 850 0.0 0.2 1.2 2.8 2.9 200–299 BEDS ...... 468 0.1 0.1 0.5 2.0 2.1 300–499 BEDS ...... 399 0.1 0.0 ¥0.4 1.1 1.2 500 + BEDS ...... 213 0.0 0.1 ¥2.2 ¥0.7 ¥0.6 BEDS (RURAL): 0–49 BEDS ...... 333 ¥0.5 ¥0.2 2.1 2.7 2.9 50–100 BEDS ...... 297 ¥0.2 ¥0.2 1.9 2.8 3.0 101–149 BEDS ...... 97 ¥0.3 0.1 1.1 2.3 2.5 150–199 BEDS ...... 49 ¥0.2 0.1 0.7 1.9 2.1 200 + BEDS ...... 38 ¥0.3 0.4 0.8 2.4 2.5 REGION (URBAN): NEW ENGLAND ...... 144 0.2 0.4 ¥0.3 1.7 1.7 MIDDLE ATLANTIC ...... 348 0.1 ¥0.2 ¥0.1 1.2 1.3 SOUTH ATLANTIC ...... 463 0.0 0.3 ¥0.4 1.3 1.4 EAST NORTH CENT ...... 471 0.0 0.1 ¥0.2 1.3 1.4 EAST SOUTH CENT ...... 178 ¥0.1 ¥0.1 ¥1.6 ¥0.4 ¥0.3 WEST NORTH CENT ...... 191 0.0 0.5 ¥0.6 1.3 1.4 WEST SOUTH CENT ...... 513 0.0 0.3 0.9 2.5 2.6 MOUNTAIN ...... 211 0.3 ¥0.9 ¥0.2 0.5 0.8 PACIFIC ...... 383 0.1 0.0 ¥0.6 0.8 0.9 PUERTO RICO ...... 49 ¥0.2 0.2 2.9 4.3 4.4 REGION (RURAL): NEW ENGLAND ...... 21 0.1 1.5 1.2 4.2 4.2
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TABLE 88—ESTIMATED IMPACT OF THE CY 2018 CHANGES FOR THE HOSPITAL OUTPATIENT PROSPECTIVE PAYMENT SYSTEM—Continued
All budget neutral APC New wage changes Number of recalibration index and 340B (combined hospitals (all provider adjustment cols 2–4) All changes changes) adjustments with market basket update
(1) (2) (3) (4) (5) (6)
MIDDLE ATLANTIC ...... 53 0.0 ¥0.5 1.8 2.6 2.7 SOUTH ATLANTIC ...... 124 ¥0.4 ¥0.6 0.7 1.1 1.2 EAST NORTH CENT ...... 122 ¥0.2 0.0 1.5 2.7 2.8 EAST SOUTH CENT ...... 155 ¥0.6 ¥0.1 0.0 0.7 0.8 WEST NORTH CENT ...... 98 ¥0.1 0.2 2.4 3.9 4.1 WEST SOUTH CENT ...... 161 ¥0.6 0.3 2.6 3.6 3.7 MOUNTAIN ...... 56 0.0 ¥0.3 1.9 3.0 3.3 PACIFIC ...... 24 ¥0.1 0.1 1.7 3.0 3.1 TEACHING STATUS: NON-TEACHING ...... 2,655 0.0 0.1 1.3 2.8 2.9 MINOR ...... 761 0.1 0.1 0.1 1.6 1.7 MAJOR ...... 349 0.1 0.0 ¥2.4 ¥1.0 ¥0.9 DSH PATIENT PERCENT: 0 ...... 10 0.0 0.2 3.2 4.8 4.9 GT 0–0.10 ...... 272 0.2 ¥0.1 2.8 4.4 4.5 0.10–0.16 ...... 263 0.1 0.0 2.7 4.3 4.4 0.16–0.23 ...... 572 0.1 0.3 2.6 4.4 4.5 0.23–0.35 ...... 1,132 0.0 0.1 ¥0.4 1.0 1.2 GE 0.35 ...... 935 0.0 0.0 ¥2.2 ¥0.9 ¥0.8 DSH NOT AVAILABLE ** ...... 581 ¥2.0 0.1 2.0 1.4 1.5 URBAN TEACHING/DSH: TEACHING & DSH ...... 1,002 0.1 0.0 ¥1.1 0.3 0.4 NO TEACHING/DSH ...... 1,386 0.1 0.2 1.3 3.0 3.1 NO TEACHING/NO DSH ...... 10 0.0 0.2 3.2 4.8 4.9 DSH NOT AVAILABLE ** ...... 553 ¥2.0 0.1 1.9 1.4 1.5 TYPE OF OWNERSHIP: VOLUNTARY ...... 1,979 0.0 0.0 ¥0.3 1.2 1.3 PROPRIETARY ...... 1,293 0.1 0.1 2.7 4.4 4.5 GOVERNMENT ...... 493 ¥0.1 0.2 ¥1.6 ¥0.1 0.0 CMHCs ...... 49 12.5 0.2 3.2 17.8 17.2 Column (1) shows total hospitals and/or CMHCs. Column (2) includes all CY 2018 OPPS policies and compares those to the CY 2017 OPPS. Column (3) shows the budget neutral impact of updating the wage index by applying the FY 2018 hospital inpatient wage index, including all hold harmless policies and transitional wages. The rural adjustment continues our current policy of 7.1 percent so the budget neutrality factor is 1. The budget neutrality adjustment for the cancer hospital adjustment is 1.0008 because the target payment-to-cost ratio changes from 0.91 in CY 2017 to 0.89 in CY 2018 and is further reduced by 1 percentage point to 0.88 in accordance with the 21st Century Cures Act. However, this reduction does not affect the budget neutrality adjustment consistent with statute. Column (4) shows the impact of the 340B drug payment reductions and the corresponding increase in non-drug payments. Column (5) shows the impact of all budget neutrality adjustments and the addition of the 1.35 percent OPD fee schedule update factor (2.7 percent reduced by 0.6 percentage points for the productivity adjustment and further reduced by 0.75 percentage point as required by law). Column (6) shows the additional adjustments to the conversion factor resulting from the frontier adjustment, a change in the pass-through esti- mate, and adding estimated outlier payments. * These 3,878 providers include children and cancer hospitals, which are held harmless to pre-BBA amounts, and CMHCs. ** Complete DSH numbers are not available for providers that are not paid under IPPS, including rehabilitation, psychiatric, and long-term care hospitals.
(4) Estimated Effects of OPPS Changes excluded days with 1 or 2 services increase of 0.2 percent to CMHCs. on CMHCs because our policy only pays a per diem Column 5 shows that combining this The last line of Table 88 demonstrates rate for partial hospitalization when 3 or OPD fee schedule increase factor, along the isolated impact on CMHCs, which more qualifying services are provided to with changes in APC policy for CY 2018 furnish only partial hospitalization the beneficiary. We estimate that and the FY 2018 wage index updates, services under the OPPS. In CY 2017, CMHCs will experience an overall 17.2 will result in an estimated increase of CMHCs are paid under APC 5853 percent increase in payments from CY 17.8 percent. Column 6 shows that (Partial Hospitalization (3 or more 2017 (shown in Column 6). We note that adding the changes in outlier and pass- services) for CMHCs). We modeled the this includes the trimming methodology though payments will result in a total impact of this APC policy assuming that described in section VIII.B. of this final 17.2 percent increase in payment for CMHCs will continue to provide the rule with comment period. CMHCs. This reflects all changes to same number of days of PHP care as Column 3 shows that the estimated CMHCs for CY 2018. seen in the CY 2016 claims data used for impact of adopting the FY 2018 wage this final rule with comment period. We index values will result in a small
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(5) Estimated Effect of OPPS Changes on • Alternatives considered for the did not propose or finalize, retaining Beneficiaries enforcement instruction for the our methodology from CY 2017 and supervision of outpatient therapeutic assigning skin substitutes to the high For services for which the beneficiary services in critical access hospitals cost group based on whether an pays a copayment of 20 percent of the (CAHs) and certain small rural hospitals individual product’s MUC or PDC payment rate, the beneficiary’s payment We considered whether to address exceeded the overall CY 2018 MUC or will increase for services for which the enforcement of the direct supervision PDC threshold based on calculations OPPS payments will rise and will requirement for outpatient therapeutic done for either the proposed rule or this decrease for services for which the services in CAHs and small, rural final rule with comment period. OPPS payments will fall. For further hospitals with fewer than 100 beds by b. Estimated Effects of CY 2018 ASC discussion on the calculation of the extending the notice of nonenforcement Payment System Policies national unadjusted copayments and while we further develop our policies. Most ASC payment rates are minimum unadjusted copayments, we There are grounds for applying the same refer readers to section II.I. of this final calculated by multiplying the ASC supervision requirements to CAHs as to conversion factor by the ASC relative rule with comment period. In all cases, all other hospitals. One of these grounds payment weight. As discussed fully in section 1833(t)(8)(C)(i) of the Act limits is that hospital outpatient services are section XII. of this final rule with beneficiary liability for copayment for a furnished ‘‘incident to’’ physicians’ comment period, we are setting the CY procedure performed in a year to the services, and we believe that the 2018 ASC relative payment weights by hospital inpatient deductible for the incident to rules apply equally to scaling the CY 2018 OPPS relative applicable year. critical access and other types of payment weights by the ASC scalar of We estimate that the aggregate hospitals. We also believe that Medicare 0.8990. The estimated effects of the beneficiary coinsurance percentage will should purchase the same basic level of updated relative payment weights on be 18.5 percent for all services paid quality and safe outpatient care for all payment rates are varied and are beneficiaries, whether from a CAH, a under the OPPS in CY 2018. The reflected in the estimated payments small rural hospital, or other hospitals. estimated aggregate beneficiary displayed in Tables 89 and 90 below. At the same time, we acknowledge that coinsurance reflects general system Beginning in CY 2011, section 3401 of in order to ensure the same level of the Affordable Care Act requires that the adjustments, including the CY 2018 outpatient care is furnished in CAHs annual update to the ASC payment comprehensive APC payment policy and small rural hospitals as other system (which currently is the CPI–U) discussed in section II.A.2.e. of this hospitals, we need to continue the after application of any quality reporting final rule with comment period. national discussion about what reduction be reduced by a productivity (6) Estimated Effects of OPPS Changes constitutes the appropriate supervision adjustment. The Affordable Care Act on Other Providers for a given service. We also need to defines the productivity adjustment to acknowledge the challenges CAHs and be equal to the 10-year moving average The relative payment weights and small, rural hospitals have in recruiting of changes in annual economy-wide payment amounts established under the and retaining physicians and qualified private nonfarm business multifactor OPPS affect the payments made to ASCs non-physician practitioners. productivity (MFP) (as projected by the as discussed in section XII. of this final Therefore, we are extending the notice Secretary for the 10-year period ending rule with comment period. No types of of nonenforcement for CAHs and small with the applicable fiscal year, year, providers or suppliers other than rural hospitals with fewer than 100 beds cost reporting period, or other annual hospitals, CMHCs, and ASCs will be for CY 2018 and CY 2019, to give all period). For ASCs that fail to meet their affected by the changes in this final rule parties time to submit specific services quality reporting requirements, the CY with comment period. to be considered for a reduced 2018 payment determinations will be minimum supervision standard. We based on the application of a 2.0 (7) Estimated Effects of OPPS Changes believe that the policies in this final rule percentage points reduction to the on the Medicare and Medicaid Programs with comment period will address annual update factor, which currently is industry concerns while maintaining an the CPI–U. We calculated the CY 2018 The effect on the Medicare program is adequate level of safety and quality of ASC conversion factor by adjusting the expected to be an increase of $690 care in the hospital outpatient services CY 2017 ASC conversion factor by million in program payments for OPPS that Medicare purchases. 1.0007 to account for changes in the pre- services furnished in CY 2018. The • floor and pre-reclassified hospital wage effect on the Medicaid program is Alternatives Considered for the Methodology for Assigning Skin indexes between CY 2017 and CY 2018 expected to be limited to copayments Substitutes to High or Low Cost Groups and by applying the CY 2018 MFP- that Medicaid may make on behalf of adjusted CPI–U update factor of 1.2 Medicaid recipients who are also We refer readers to section V.B.1.d. of percent (projected CPI–U update of 1.7 Medicare beneficiaries. We refer readers this final rule with comment period for percent minus a projected productivity to our discussion of the impact on a discussion of our proposal to assign adjustment of 0.5 percentage point). The beneficiaries in section XVIII.A.4.a.(4) of any skin substitute product that was CY 2018 ASC conversion factor is this final rule with comment period. assigned to the high cost group in CY $45.575. 2017 to the high cost group in CY 2018, (8) Alternative OPPS Policies regardless of whether the product’s (1) Limitations of Our Analysis Considered mean unit cost (MUC) or the product’s Presented here are the projected per day cost (PDC) exceeds or falls effects of the changes for CY 2018 on Alternatives to the OPPS changes we below the overall CY 2018 MUC or PDC Medicare payment to ASCs. A key are making and the reasons for our threshold. We will continue to assign limitation of our analysis is our inability selected alternatives are discussed products that exceed either the overall to predict changes in ASC service-mix throughout this final rule with comment CY 2018 MUC or PDC threshold to the between CY 2016 and CY 2018 with period. high cost group. We also considered, but precision. We believe that the net effect
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on Medicare expenditures resulting ancillary items and services group by specialty and ancillary items and from the CY 2018 changes will be small comparing estimated CY 2017 payments services groups are displayed in in the aggregate for all ASCs. However, to estimated CY 2018 payments, and descending order based on estimated CY such changes may have differential Table 90 shows a comparison of 2017 ASC payments. effects across surgical specialty groups estimated CY 2017 payments to • Column 3—Estimated CY 2018 as ASCs continue to adjust to the estimated CY 2018 payments for Percent Change is the aggregate payment rates based on the policies of procedures that we estimate will receive percentage increase or decrease in the revised ASC payment system. We the most Medicare payment in CY 2017. Medicare program payment to ASCs for are unable to accurately project such Table 89 shows the estimated effects each surgical specialty or ancillary changes at a disaggregated level. Clearly, on aggregate Medicare payments under individual ASCs will experience the ASC payment system by surgical items and services group that are changes in payment that differ from the specialty or ancillary items and services attributable to updates to ASC payment aggregated estimated impacts presented group. We have aggregated the surgical rates for CY 2018 compared to CY 2017. below. HCPCS codes by specialty group, As seen in Table 89, for the six grouped all HCPCS codes for covered specialty groups that account for the (2) Estimated Effects of ASC Payment ancillary items and services into a single most ASC utilization and spending, we System Policies on ASCs group, and then estimated the effect on estimate that the update to ASC Some ASCs are multispecialty aggregated payment for surgical payment rates for CY 2017 will result in facilities that perform a wide range of specialty and ancillary items and a 1-percent increase in aggregate surgical procedures from excision of services groups. The groups are sorted payment amounts for eye and ocular lesions to hernia repair to cataract for display in descending order by adnexa procedures, a 2-percent increase extraction; others focus on a single estimated Medicare program payment to in aggregate payment amounts for specialty and perform only a limited ASCs. The following is an explanation digestive system procedures, 1-percent range of surgical procedures, such as of the information presented in Table increase in aggregate payment amounts eye, digestive system, or orthopedic 89. • for nervous system procedures, a 3- procedures. The combined effect on an Column 1—Surgical Specialty or percent increase in aggregate payment individual ASC of the update to the CY Ancillary Items and Services Group amounts for musculoskeletal system 2018 payments will depend on a indicates the surgical specialty into procedures, a 1-percent increase in number of factors, including, but not which ASC procedures are grouped and aggregate payment amounts for limited to, the mix of services the ASC the ancillary items and services group genitourinary system procedures, and a provides, the volume of specific services which includes all HCPCS codes for 5-percent increase in aggregate payment provided by the ASC, the percentage of covered ancillary items and services. To amounts for integumentary system its patients who are Medicare group surgical procedures by surgical procedures. beneficiaries, and the extent to which an specialty, we used the CPT code range ASC provides different services in the definitions and Level II HCPCS codes Also displayed in Table 89 is a coming year. The following discussion and Category III CPT codes as separate estimate of Medicare ASC presents tables that display estimates of appropriate, to account for all surgical payments for the group of separately the impact of the CY 2018 updates to procedures to which the Medicare payable covered ancillary items and the ASC payment system on Medicare program payments are attributed. services. The payment estimates for the payments to ASCs, assuming the same • Column 2—Estimated CY 2017 ASC covered surgical procedures include the mix of services as reflected in our CY Payments were calculated using CY costs of packaged ancillary items and 2016 claims data. Table 89 depicts the 2016 ASC utilization (the most recent services. We estimate that aggregate estimated aggregate percent change in full year of ASC utilization) and CY payments for these items and services payment by surgical specialty or 2017 ASC payment rates. The surgical will decrease by 44 percent for CY 2018.
TABLE 89—ESTIMATED IMPACT OF THE CY 2018 UPDATE TO THE ASC PAYMENT SYSTEM ON AGGREGATE CY 2018 MEDICARE PROGRAM PAYMENTS BY SURGICAL SPECIALTY OR ANCILLARY ITEMS AND SERVICES GROUP
Estimated CY 2017 Estimated Surgical specialty group ASC CY 2018 payments percent (in millions) change
(1) (2) (3)
Total ...... $4,460 1 Eye and ocular adnexa ...... 1,688 1 Digestive system ...... 852 2 Nervous system ...... 849 1 Musculoskeletal system ...... 530 3 Genitourinary system ...... 186 1 Integumentary system ...... 141 5 Ancillary items and services ...... 55 ¥44
Table 90 below shows the estimated procedures during CY 2018. The table HCPCS codes are sorted in descending impact of the updates to the revised displays 30 of the procedures receiving order by estimated CY 2017 program ASC payment system on aggregate ASC the greatest estimated CY 2017 aggregate payment. payments for selected surgical Medicare payments to ASCs. The • Column 1—CPT/HCPCS code.
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• Column 2—Short Descriptor of the 2017 ASC payment rates. The estimated payment for CY 2017 and the estimated HCPCS code. CY 2017 payments are expressed in payment for CY 2018 based on the • Column 3—Estimated CY 2017 ASC millions of dollars. update. Payments were calculated using CY • Column 4—Estimated CY 2018 2016 ASC utilization (the most recent Percent Change reflects the percent full year of ASC utilization) and the CY differences between the estimated ASC
TABLE 90—ESTIMATED IMPACT OF THE CY 2018 UPDATE TO THE ASC PAYMENT SYSTEM ON AGGREGATE PAYMENTS FOR SELECTED PROCEDURES
Estimated CY Estimated CPT/HCPCS 2017 ASC CY 2018 code Short descriptor payment percent (in millions) change
(1) (2) (3) (4)
66984 ...... Cataract surg w/iol 1 stage ...... $1,172 1 45380 ...... Colonoscopy and biopsy ...... 216 3 43239 ...... Egd biopsy single/multiple ...... 178 2 63685 ...... Insrt/redo spine n generator ...... 151 ¥1 45385 ...... Colonoscopy w/lesion removal ...... 146 3 63650 ...... Implant neuroelectrodes ...... 118 4 64483 ...... Inj foramen epidural l/s ...... 99 1 66982 ...... Cataract surgery complex ...... 94 1 0191T ...... Insert ant segment drain int ...... 86 1 66821 ...... After cataract laser surgery ...... 69 0 64635 ...... Destroy lumb/sac facet jnt ...... 68 0 29827 ...... Arthroscop rotator cuff repr ...... 61 3 64493 ...... Inj paravert f jnt l/s 1 lev ...... 60 1 64590 ...... Insrt/redo pn/gastr stimul ...... 50 2 G0105 ...... Colorectal scrn; hi risk ind ...... 45 3 62323 ...... Njx interlaminar lmbr/sac ...... 45 3 45378 ...... Diagnostic colonoscopy ...... 44 3 G0121 ...... Colon ca scrn not hi rsk ind ...... 42 3 64721 ...... Carpal tunnel surgery ...... 34 ¥1 15823 ...... Revision of upper eyelid ...... 32 6 29881 ...... Knee arthroscopy/surgery ...... 30 5 29880 ...... Knee arthroscopy/surgery ...... 26 5 67042 ...... Vit for macular hole ...... 25 1 28285 ...... Repair of hammertoe ...... 24 5 52000 ...... Cystoscopy ...... 23 ¥1 26055 ...... Incise finger tendon sheath ...... 23 6 43235 ...... Egd diagnostic brush wash ...... 23 2 64561 ...... Implant neuroelectrodes ...... 22 6 50590 ...... Fragmenting of kidney stone ...... 21 1 67904 ...... Repair eyelid defect ...... 20 2
(3) Estimated Effects of ASC Payment payment system are lower than payment generally will be no greater than the System Policies on Beneficiaries rates for the same procedures under the beneficiary coinsurance under the We estimate that the CY 2018 update OPPS. Therefore, the beneficiary MPFS because the coinsurance under to the ASC payment system will be coinsurance amount under the ASC both payment systems generally is 20 generally positive for beneficiaries with payment system will almost always be percent (except for certain preventive respect to the new procedures that we less than the OPPS copayment amount services where the coinsurance is are adding to the ASC list of covered for the same services. (The only waived under both payment systems). surgical procedures and for those that exceptions would be if the ASC (4) Alternative ASC Payment Policies we are designating as office-based for coinsurance amount exceeds the Considered CY 2018. First, other than certain inpatient deductible. The statute preventive services where coinsurance requires that copayment amounts under Alternatives to the ASC changes we and the Part B deductible is waived to the OPPS not exceed the inpatient are making and the reasons for our comply with sections 1833(a)(1) and (b) deductible.) Beneficiary coinsurance for selected alternatives are discussed of the Act, the ASC coinsurance rate for services migrating from physicians’ throughout this final rule with comment all procedures is 20 percent. This offices to ASCs may decrease or increase period. contrasts with procedures performed in under the revised ASC payment system, c. Accounting Statements and Tables HOPDs under the OPPS, where the depending on the particular service and beneficiary is responsible for the relative payment amounts under the As required by OMB Circular A–4 copayments that range from 20 percent MPFS compared to the ASC. However, (available on the Office of Management to 40 percent of the procedure payment for those additional procedures that we and Budget Web site at: https:// (other than for certain preventive are designating as office-based in CY www.whitehouse.gov/omb/circulars_ services). Second, in almost all cases, 2018, the beneficiary coinsurance a004_a-4#a), we have prepared two the ASC payment rates under the ASC amount under the ASC payment system accounting statements to illustrate the
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impacts of this final rule with comment 2018 OPD fee schedule increase. The provisions of this final rule with period. The first accounting statement, second accounting statement, Table 92 comment period and the baseline Table 91 below, illustrates the below, illustrates the classification of spending estimates for ASCs. Lastly, the classification of expenditures for the CY expenditures associated with the 1.2 tables classify most estimated impacts 2018 estimated hospital OPPS incurred percent CY 2018 update to the ASC as transfers. benefit impacts associated with the CY payment system, based on the
TABLE 91—ACCOUNTING STATEMENT: CY 2018 ESTIMATED HOSPITAL OPPS TRANSFERS FROM CY 2017 TO CY 2018 ASSOCIATED WITH THE CY 2018 HOSPITAL OUTPATIENT OPD FEE SCHEDULE INCREASE
Category Transfers
Annualized Monetized Transfers ...... $690 million. From Whom to Whom ...... Federal Government to outpatient hospitals and other providers who receive payment under the hospital OPPS.
Total ...... $690 million.
TABLE 92—ACCOUNTING STATEMENT: CLASSIFICATION OF ESTIMATED TRANSFERS FROM CY 2017 TO CY 2018 AS A RESULT OF THE CY 2018 UPDATE TO THE ASC PAYMENT SYSTEM
Category Transfers
Annualized Monetized Transfers ...... $40 million. From Whom to Whom ...... Federal Government to Medicare Providers and Suppliers.
Total ...... $40 million.
d. Effects of Requirements for the Surgery Checklist beginning with the the CY 2020 payment determination (CY Hospital OQR Program CY 2021 payment determination, we are 2018 data collection period) until finalizing removal of these measures further notice in future rulemaking. (1) Background with modification so that removal In addition, in this final rule with We refer readers to the CY 2017 begins with the CY 2020 payment comment period, beginning with the CY OPPS/ASC final rule with comment determination, one year earlier than 2020 payment determination, we are period (81 FR 79874), for the previously proposed. To summarize, the following finalizing our proposals: (1) To codify at estimated effects of changes to the measures will be removed for the CY § 419.46(e) our previously finalized Hospital OQR Program for the CY 2018, 2020 payment determination: (1) OP–1: process for targeting hospitals for CY 2019, and CY 2020 payment Median Time to Fibrinolysis; (2) OP–4: validation of chart-abstracted measures determinations. Of the 3,228 hospitals Aspirin at Arrival; (3) OP–20: Door to (section XIII.D.7.b. of this final rule with that met eligibility requirements for the Diagnostic Evaluation by a Qualified comment period); (2) to formalize the CY 2017 payment determination, we Medical Professional; (4) OP–21: educational review process and use it to determined that 87 hospitals did not Median Time to Pain Management for correct incorrect validation results for meet the requirements to receive the full Long Bone Fracture; (5) OP–25: Safe chart-abstracted measures (section OPD fee schedule increase factor. Most Surgery Checklist; and (6) OP–26: XIII.D.7.c. of this final rule with of these hospitals (66 of the 87), chose Hospital Outpatient Volume Data on comment period); (3) to align the first not to participate in the Hospital OQR Selected Outpatient Surgical quarter for which hospitals must submit Program for the CY 2017 payment Procedures. We expect these finalized data for all hospitals that did not determination. We estimate that proposals will reduce the burden of participate in the previous year’s approximately 100 hospitals will not reporting for the Hospital OQR Program, Hospital OQR Program, and make receive the full OPD fee schedule as discussed in more detail below. corresponding revisions at 42 CFR increase factor for the CY 2018 payment In section XIII.B.10.b. of this final rule 419.46(c)(3) (section XIII.D.1. of this determination and subsequent years. with comment period, we are finalizing, final rule with comment period); and (4) In section XIII.B.4.c. of this final rule with modifications, our proposal to to align the naming of the Extraordinary with comment period, we are finalizing publicly report OP–18c using data Circumstances Exceptions (ECE) policy the removal of six measures. beginning with patient encounters and make conforming changes to the Specifically, beginning with the CY during the third quarter of 2017. CFR (section XIII.D.8.a. of this final rule 2020 payment determination, we are However, we do not expect our with comment period). We are not finalizing, as proposed, to remove: (1) modifications to affect the burden finalizing our proposals to change the OP–21: Median Time to Pain estimates made in the CY 2018 OPPS/ NOP submission deadlines such that Management for Long Bone Fracture; ASC proposed rule (82 FR 33705 hospitals are required to submit the and (2) OP–26: Hospital Outpatient through 33708), as discussed below. NOP any time prior to registering on the Volume Data on Selected Outpatient In section XIII.B.5. of this final rule QualityNet Web site and to make Surgical Procedures. Also, while we with comment period, we are finalizing conforming revisions at 42 CFR proposed to remove: (1) OP 1: Median our proposal to delay the OP–37a–e: 419.46(a) (section XIII.C.2.b. of this final Time to Fibrinolysis, (2) OP–4: Aspirin Outpatient and Ambulatory Surgery rule with comment period). We do not at Arrival, (3) OP–20: Door to Diagnostic Consumer Assessment of Healthcare believe that these changes will affect our Evaluation by a Qualified Medical Providers and Systems (OAS CAHPS) burden estimates, as further discussed Professional, and (4) OP–25: Safe Survey-based measures beginning with below.
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(2) Estimated Impact of Newly Finalized our proposals to remove six measures incorrect validation results for the first Proposal To Delay OP–37a–e: from the Hospital OQR Program. three quarters of validation for chart- Outpatient and Ambulatory Surgery Specifically, beginning with the CY abstracted measures. We are also Consumer Assessment of Healthcare 2020 payment determination, we are finalizing our proposal to update the Providers and Systems (OAS CAHPS) finalizing, as proposed, to remove: (1) process to specify that if the results of Survey-Based Measures Beginning With OP–21: Median Time to Pain an educational review indicate that we the CY 2020 Payment Determination Management for Long Bone Fracture; incorrectly scored a hospital’s medical As described in section XIII.B.5. of and (2) OP–26: Hospital Outpatient records selected for validation, the this final rule with comment period, we Volume Data on Selected Outpatient corrected quarterly validation score will Surgical Procedures. Also, while we are finalizing our proposal to delay OP– be used to compute the hospital’s final proposed to remove: (1) OP 1: Median 37a–e: Outpatient and Ambulatory validation score at the end of the Surgery Consumer Assessment of Time to Fibrinolysis, (2) OP–4: Aspirin at Arrival, (3) OP–20: Door to Diagnostic calendar year. Under this finalized Healthcare Providers and Systems (OAS policy, the educational review request CAHPS) Survey-based measures Evaluation by a Qualified Medical Professional, and (4) OP–25: Safe process remains the same for the CY beginning with the CY 2020 payment 2020 payment determination and determination (CY 2018 data collection Surgery Checklist beginning with the CY 2021 payment determination, we are subsequent years, except that revised period). As stated in the CY 2017 OPPS/ scores identified through an educational ASC final rule with comment period (81 finalizing removal of these measures review will be used to correct a FR 79863), the information collection with modification so that removal hospital’s validation score. As a result, requirements associated with the five begins with the CY 2020 payment we do not expect this policy to affect the OAS CAHPS Survey-based measures determination, one year earlier than (OP–37a, OP–37b, OP–37c, OP–37d, and proposed. In summary, we are finalizing burden experienced by hospitals, as our OP–37e) are currently approved under removal of six measures beginning with changes to this policy result in a change the CY 2020 payment determination. OMB Control Number 0938–1240. For in the way we address educational We note that we have modified our this reason, in the CY 2017 OPPS/ASC review requests and not a change to the estimates from the proposed rule (82 FR final rule with comment period (81 FR process hospitals must follow to request 33673) in order to streamline our 79863), we did not provide an an education review. As we stated in the discussion in light of the modification. independent estimate of the burden CY 2014 OPPS/ASC final rule with Specifically, we are finalizing the comment period (78 FR 75171), we associated with OAS CAHPS Survey removal of four chart-abstracted believe there is a burden associated with based measures for the Hospital OQR measures ((1) OP–1: Median Time to successful participation in the Hospital Program. Similarly, our finalized Fibrinolysis; (2) OP–4: Aspirin at proposal to delay implementation of Arrival; (3) OP–20: Door to Diagnostic OQR Program, where successful these measures does not affect our Evaluation by a Qualified Medical participation results in a full annual current burden estimates. Professional; and (4) OP–21: Median payment update (APU) for a particular (3) Estimated Impact of Proposal To Time to Pain Management for Long payment determination. This burden Publicly Report OP–18c: Median Time Bone Fracture) and two Web-based includes, but is not limited to, From Emergency Department Arrival to measures ((1) OP–25: Safe Surgery maintaining familiarity with the Emergency Department Departure for Checklist Use; and (2) OP–26: Hospital Hospital OQR Program requirements, Discharged Emergency Department Outpatient Volume Data on Selected which includes checking feedback Patients—Psychiatric/Mental Health Outpatient Surgical Procedures). As reports to indicate a facility’s current Patients described in section XVI.B. of this final status or performance (78 FR 75171). rule with comment period, we expect In section XIII.B.10.b. of this final rule The overall administrative burden was these measure removals to reduce with comment period, we are finalizing, estimated at 42 hours per hospital (78 burden by 457,490 hours and $16.7 with modifications, our proposal to FR 75171). As stated above, we do not million for the CY 2020 payment publicly report 18c: Median Time from believe this burden will change with the determination. Emergency Department Arrival to finalization of our policy to update the Emergency Department Departure for (b) Impact of Updates to Previously educational review process to include Discharged Emergency Department Finalized Chart-Abstracted Measure corrections. Validation Procedures and the Patients—Psychiatric/Mental Health (c) Impact of Proposed Update to NOP Patients beginning with patient Educational Review Process Submission Deadline encounters from the third quarter of In section XIII.D.7.a. of this final rule 2017. As noted in that section, the data with comment period, we provide In section XIII.C.2. of this final rule required for public reporting of OP–18c clarification on our procedures for with comment period, we are not is already collected as part of the validation of chart-abstracted measures finalizing our proposal to revise the existing Hospital OQR Program to note that the 50 poorest performing NOP submission deadlines such that requirements. Accordingly, we did not outlier hospitals will be targeted for hospitals are required to submit the estimate changes to burden due to this validation. We do not expect this NOP any time prior to registering on the proposal and we do not expect the clarification to affect burden because it QualityNet Web site. We estimated that modifications we are finalizing to affect does not alter the number of hospitals this proposal would have a negligible burden. selected for validation or the effect on the time and cost of (4) Estimated Impact of Newly Finalized requirements for those hospitals that are completing the participation Proposals for the CY 2020 Payment selected. requirements. As a result, our decision Determination and Subsequent Years In addition, in section XIII.D.7.c. of not to finalize the proposal to revise the this final rule with comment period, we NOP submission deadline does not (a) Impact of Measure Removals are finalizing our proposal to formalize affect our burden estimates. In section XIII.B.4.c. of this final rule the process of allowing hospitals to use with comment period, we are finalizing an educational review process to correct
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(d) Impact of Aligning the First Quarter payment update in CY 2018 due to rulemaking. As described in the CY for Which Hospitals Must Submit Data failure to meet the ASCQR Program 2017 OPPS/ASC final rule with for All Hospitals That Did Not requirements (CY 2017 and CY 2018 comment period (81 FR 79864), the Participate in the Previous Year’s payment determination information information collection requirements Hospital OQR Program were not yet available). associated with the five OAS CAHPS In section XIII.D.1 of this final rule In section XIV.B.3.b. of this final rule Survey based measures (ASC–15a, ASC– with comment period, we are finalizing with comment period, we are finalizing 15b, ASC–15c, ASC–15d, and ASC–15e) our proposal to align the timeline our proposals, beginning with the CY are currently approved under OMB 2019 payment determination, to remove specifying the initial quarter for which Control Number 0938–1240. For this three measures (ASC–5: Prophylactic hospitals must submit data for all reason, we did not provide an Intravenous (IV) Antibiotic Timing, hospitals that did not participate in the independent estimate of the burden ASC–6: Safe Surgery Checklist Use, and previous year’s Hospital OQR Program, associated with OAS CAHPS Survey ASC–7: Ambulatory Surgical Center rather than specifying different administration for the ASCQR Program Facility Volume Data on Selected timelines for hospitals with Medicare in the CY 2017 OPPS/ASC final rule Ambulatory Surgical Center Surgical acceptance dates before versus after with comment period (81 FR 79864). Procedures) from the ASCQR Program Similarly, our finalized proposal to January 1 of the year prior to an affected measure set. In section XIV.B.6.a. of this delay reporting on these measures does annual payment update. Although this final rule with comment period, we are not affect our current burden estimates. finalized proposal alters the timeline for not finalizing our proposal, beginning For CY 2018, we are finalizing two hospitals to begin submitting data for with the CY 2021 payment additional policies. First, in section the Hospital OQR Program, it does not determination, to adopt one new XIV.D.3.b. of this final rule with alter program requirements. As a result, measure, ASC–16: Toxic Anterior comment period, we are finalizing our we do not anticipate that this policy Segment Syndrome. In section proposal to expand the CMS online tool will affect burden. XIV.B.6.b. and c. of this final rule with to also allow for batch submission (e) Impact of Updates to the Previously comment period, we are finalizing our beginning with data submitted during Finalized ECE Policy proposals, beginning with the CY 2022 CY 2018 and to make corresponding We previously estimated the burden payment determination, to adopt two revisions to the CFR. Second, in section associated with general and new measures collected via claims XIV.D.6. of this final rule with comment (ASC–17: Hospital Visits after period, we discuss our intent to align administrative Hospital OQR Program Orthopedic Ambulatory Surgical Center the naming of this exception policy and requirements in the CY 2014 OPPS/ASC Procedures and ASC–18: Hospital Visits update 42 CFR 416.310(d) to reflect our final rule with comment period (78 FR after Urology Ambulatory Surgical current ECE policies. We are also 75171). In section XIII.D.8. of this final Center Procedures). We expect these clarifying the timing of CMS’ response rule with comment period, we discuss finalized proposals will reduce the to ECE requests. Because none of these our finalized alignment of the naming of overall burden of reporting data for the policies change the reporting this exception policy and finalized ASCQR Program, as discussed below. requirements of the ASCQR Program or proposal to update 42 CFR 419.46(d) to In this final rule with comment require ASCs to submit any new or reflect our current ECE policies. We are period, we are also finalizing our additional information, we believe the also clarifying the timing of our proposals: (1) To delay ASC–15a–e: updates will have no effect on burden response to ECE requests. Because we OAS CAHPS survey-based measures for ASCs. do not seek any new or additional beginning with the CY 2020 payment information in our finalized ECE determination (CY 2018 data collection) 3. Estimated Burden of Newly Finalized proposals, we believe the updates will (section XIV.B.4. of this final rule with ASCQR Program Proposals for the CY have no effect on burden for hospitals. comment period); (2) to expand the 2019 Payment Determination We refer readers to section XVI.B. of CMS online tool to also allow for batch In section XIV.B.3.b. of this final rule this final rule with comment period submission beginning with data with comment period, we are finalizing (information collection requirements) submitted during CY 2018 and to make our proposals to remove one claims- for a detailed discussion of the burden corresponding revisions to the CFR based measure (ASC–5: Prophylactic of the requirements for submitting data (section XIV.D.3.b. of this final rule with Intravenous (IV) Antibiotic Timing 218) to the Hospital OQR Program. comment period); and, (3) to align the and two measures collected via a CMS e. Effects of Proposed Requirements for naming of the Extraordinary online data submission tool (ASC–6: the ASCQR Program Circumstances Exceptions (ECE) policy Safe Surgery Checklist Use and ASC–7: beginning with CY 2018 and to make ASC Facility Volume Data on Selected 1. Background conforming changes to the CFR (section ASC Surgical Procedures) from the In section XIV. of this final rule with XIV.D.6.b. of this final rule with ASCQR Program measure set beginning comment period, we discuss our comment period). As discussed below, with the CY 2019 payment proposals to adopt policies affecting the we do not expect these finalized determination. As discussed in section ASCQR Program. For the CY 2017 proposals to affect our burden estimates. XVI.C.4. of this final rule with comment payment determination, of the 3,937 period, data for ASC–5 is submitted via ASCs that met eligibility requirements 2. Estimated Burden of Newly Finalized for the ASCQR Program, 209 ASCs did ASCQR Program Proposals Beginning 218 As discussed in section XVI.C.4. of this final not meet the requirements to receive the With CY 2018 rule with comment period, data for ASC–5 is submitted via CMS claims using Quality Data full annual payment update. We note In section XIV.B.4. of this final rule Codes, which impose only a nominal burden on that, in the CY 2017 OPPS/ASC final with comment period, we are finalizing providers because these claims are already rule with comment period (81 FR our proposal to delay ASC–15a–e: OAS submitted for the purposes of payment. We 79874), we used the CY 2016 payment CAHPS Survey-based measures therefore estimate a nominal reduction in burden associated with our finalized proposal to remove determination numbers as a baseline, beginning with the CY 2020 payment the ASC–5 measure from the ASCQR Program and estimated that approximately 200 determination (CY 2018 data collection) measure set beginning with the CY 2019 payment ASCs will not receive the full annual until further notice in future determination.
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CMS claims using Quality Data Codes, require ASCs to submit any additional level is currently approximately $148 which impose only a nominal burden data, we do not believe there will be any million. This final rule with comment on providers because these claims are additional burden associated with these period does not mandate any already submitted for the purposes of proposals. requirements for State, local, or tribal payment. Therefore, we estimate a We refer readers to the information governments, or for the private sector. nominal reduction in burden associated collection requirements in section D. Reducing Regulation and Controlling with our finalized proposal to remove XVI.C. of this final rule with comment Regulatory Costs the ASC–5 measure from the ASCQR period for a detailed discussion of the Program measure set beginning with the financial and hourly burden of the Executive Order 13771, titled CY 2019 payment determination. As ASCQR Program’s current and proposed Reducing Regulation and Controlling also discussed in section XVI.C.4. of this requirements. Regulatory Costs, was issued on January final rule with comment period, we 30, 2017. Section 2(a) of Executive B. Regulatory Flexibility Act (RFA) Order 13771 requires an agency, unless estimate the proposals to remove ASC– Analysis 6 and ASC–7 from the ASCQR Program prohibited by law, to identify at least measure set will reduce ASCs’ data The RFA requires agencies to analyze two existing regulations to be repealed collection and submission burden by options for regulatory relief of small when the agency publicly proposes for approximately 657 hours (3,937 ASCs × entities, if a rule has a significant impact notice and comment, or otherwise 0.167 hours per ASC) and $24,033 (657 on a substantial number of small promulgates, a new regulation. In hours × $36.58 per hour) per measure, entities. For purposes of the RFA, we furtherance of this requirement, section or a total burden reduction of 1,314 (657 estimate that most hospitals, ASCs and 2(c) of Executive Order 13771 requires hours × 2 measures) and $48,066 (1,314 CMHCs are small entities as that term is that the new incremental costs hours × $36.58 per hour) across all used in the RFA. For purposes of the associated with new regulations shall, to ASCs. RFA, most hospitals are considered the extent permitted by law, be offset by We did not propose to add any quality small businesses according to the Small the elimination of existing costs measures to the ASCQR measure set for Business Administration’s size associated with at least two prior the CY 2020 payment determination, standards with total revenues of $38.5 regulations. OMB’s guidance, issued on and we do not believe that the other million or less in any single year or by April 5, 2017, explains that ‘‘In general, measures we previously adopted will the hospital’s not-for-profit status. Most Federal spending regulatory actions that cause any additional ASCs to fail to ASCs and most CMHCs are considered cause only income transfers between meet the ASCQR Program requirements. small businesses with total revenues of taxpayers and program beneficiaries (We refer readers to section XIV.B.5. of $15 million or less in any single year. (e.g., regulations associated with . . . this final rule with comment period for For details, see the Small Business Medicare spending) are considered a list of these measures.) Therefore, we Administration’s ‘‘Table of Small ‘transfer rules’ and are not covered by do not believe that these policies will Business Size Standards’’ at http:// EO 13771. However, in some cases, such increase the number of ASCs that do not www.sba.gov/content/table-small- regulatory actions may impose receive a full annual payment update for business-size-standards. requirements apart from transfers, or the CY 2020 payment determination. In addition, section 1102(b) of the Act transfers may distort markets causing requires us to prepare a regulatory inefficiencies. In those cases, the actions 4. Estimated Burden of ASCQR Program impact analysis if a rule may have a would need to be offset to the extent for the CY 2021 Payment Determination significant impact on the operations of they impose more than de minimis In section XIV.B.6.a. of this final rule a substantial number of small rural costs.’’ As shown in the previous with comment period, we are not hospitals. This analysis must conform to discussion of Regulatory Review Costs finalizing our proposal to adopt one the provisions of section 604 of the under section XVIII.A.4. of this final new measure collected via a CMS online RFA. For purposes of section 1102(b) of rule with comment period, we estimate data submission tool, ASC–16: Toxic the Act, we define a small rural hospital that total regulatory review costs on the Anterior Segment Syndrome. Therefore, as a hospital that is located outside of affected entities will be approximately the initially estimated burden from the a metropolitan statistical area and has $2.8 million. As discussed in section CY 2018 OPPS/ASC proposed rule (82 100 or fewer beds. We estimate that this XVI. of this final rule with comment FR 33721) does not apply. final rule with comment period will period, we estimate that this rule leads to paperwork cost savings of 5. Estimated Burden of ASCQR Program increase payments to small rural approximately $16.8 million per year on Newly Finalized Proposals for the CY hospitals by less than 3 percent; an ongoing basis. It has been determined 2022 Payment Determination therefore, it should not have a significant impact on approximately 626 that this final rule with comment period In sections XIV.B.6.b. and c. of this small rural hospitals. is a deregulatory action for the purposes final rule with comment period, we are The analysis above, together with the of Executive Order 13771. finalizing our proposals, beginning with remainder of this preamble, provides a E. Conclusion the CY 2022 payment determination, to regulatory flexibility analysis and a adopt two measures collected via regulatory impact analysis. The changes we are making in this claims: (1) ASC–17: Hospital Visits after final rule with comment period will Orthopedic Ambulatory Surgical Center C. Unfunded Mandates Reform Act affect all classes of hospitals paid under Procedures; and (2) ASC–18: Hospital Analysis the OPPS and will affect both CMHCs Visits after Urology Ambulatory Section 202 of the Unfunded and ASCs. We estimate that most classes Surgical Center Procedures. Data used to Mandates Reform Act of 1995 (UMRA) of hospitals paid under the OPPS will calculate scores for these measures is also requires that agencies assess experience a modest increase or a collected via Part A and Part B Medicare anticipated costs and benefits before minimal decrease in payment for administrative claims and Medicare issuing any rule whose mandates services furnished under the OPPS in enrollment data, and therefore does not require spending in any 1 year of $100 CY 2018. Table 88 demonstrates the require ASCs to report any additional million in 1995 dollars, updated estimated distributional impact of the data. Because these measures do not annually for inflation. That threshold OPPS budget neutrality requirements
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that will result in a 1.4 percent increase 12866, the RFA, and section 1102(b) of (iv) The results of the test do not in payments for all services paid under the Act. guide treatment provided during the the OPPS in CY 2018, after considering This final rule with comment period hospital outpatient encounter; and all of the changes to APC will affect payments to a substantial (v) The test was reasonable and reconfiguration and recalibration, as number of small rural hospitals and a medically necessary for the treatment of well as the OPD fee schedule increase small number of rural ASCs, as well as an illness. factor, wage index changes, including other classes of hospitals, CMHCs, and the frontier State wage index ASCs, and some effects may be PART 416—AMBULATORY SURGICAL adjustment, estimated payment for significant. SERVICES outliers, and changes to the pass- through payment estimate. However, List of Subjects ■ 3. The authority citation for part 416 some classes of providers that are paid 42 CFR Part 414 continues to read as follows: under the OPPS will experience more Administrative practice and Authority: Secs. 1102, 1138, and 1871 of significant gains or losses in OPPS the Social Security Act (42 U.S.C. 1302, payments in CY 2018. procedure, Health facilities, Health 1320b–8, and 1395hh) and section 371 of the professions, Kidney disease, Medicare, Public Health Service Act (42 U.S.C. 273). The updates to the ASC payment Reporting and recordkeeping system for CY 2018 will affect each of requirements. ■ 4. Section 416.310 is amended by the approximately 5,500 ASCs currently revising paragraphs (c)(1)(i) and (d) to approved for participation in the 42 CFR Part 416 read as follows: Medicare program. The effect on an Health facilities, Health professions, individual ASC will depend on its mix § 416.310. Data collection and submission Medicare, Reporting and recordkeeping requirements under the ASCQR Program. of patients, the proportion of the ASC’s requirements. patients who are Medicare beneficiaries, * * * * * the degree to which the payments for 42 CFR Part 419 (c) * * * the procedures offered by the ASC are Hospitals, Medicare, Reporting and (1) * * * changed under the ASC payment recordkeeping requirements. (i) QualityNet account for web-based system, and the extent to which the ASC measures. ASCs, and any agents provides a different set of procedures in For reasons stated in the preamble of submitting data on an ASC’s behalf, the coming year. Table 89 demonstrates this document, the Centers for Medicare must maintain a QualityNet account in the estimated distributional impact & Medicaid Services is amending 42 order to submit quality measure data to among ASC surgical specialties of the CFR chapter IV as set forth below: the QualityNet Web site for all web- MFP-adjusted CPI–U update factor of PART 414—PAYMENT FOR PART B based measures submitted via a CMS 1.2 percent for CY 2018. MEDICAL AND OTHER HEALTH online data submission tool. A XIX. Federalism Analysis SERVICES QualityNet security administrator is necessary to set up such an account for Executive Order 13132 establishes ■ 1. The authority citation for part 414 the purpose of submitting this certain requirements that an agency continues to read as follows: information. must meet when it promulgates a proposed rule (and subsequent final Authority: Secs. 1102, 1871, and * * * * * rule) that imposes substantial direct 1881(b)(1) of the Social Security Act (42 (d) Extraordinary circumstances U.S.C. 1302, 1395hh, and 1395rr(b)(1). costs on State and local governments, exceptions. CMS may grant an preempts State law, or otherwise has ■ 2. Section 414.510 is amended by exception with respect to quality data Federalism implications. We have adding paragraph (b)(5) to read as reporting requirements in the event of examined the OPPS and ASC provisions follows: extraordinary circumstances beyond the included in this final rule with control of the hospital, such as when an § 414.510 Laboratory date of service for comment period in accordance with act of nature affects an entire region or clinical laboratory and pathology if CMS determines that a systemic Executive Order 13132, Federalism, and specimens. have determined that they will not have problem with one of its data collection a substantial direct effect on State, local * * * * * systems directly affected the ability of or tribal governments, preempt State (b) * * * the hospitals to submit data. CMS may law, or otherwise have a Federalism (5) In the case of a molecular grant an exception as follows: implication. As reflected in Table 88 of pathology test or a test designated by (1) Upon request of the ASC. Specific this final rule with comment period, we CMS as an ADLT under paragraph (1) of requirements for submission of a request estimate that OPPS payments to the definition of an advanced diagnostic for an exception are available on the governmental hospitals (including State laboratory test in § 414.502, the date of QualityNet Web site; or and local governmental hospitals) will service of the test must be the date the (2) At the discretion of CMS. CMS experience no change under this final test was performed only if— may grant exceptions to ASCs that have rule with comment period. While we do (i) The test was performed following not requested them when CMS not know the number of ASCs or a hospital outpatient’s discharge from determines that an extraordinary CMHCs with government ownership, we the hospital outpatient department; circumstance has occurred. anticipate that it is small. The analyses (ii) The specimen was collected from * * * * * we have provided in this section of this a hospital outpatient during an final rule with comment period, in encounter (as both are defined in § 410.2 PART 419—PROSPECTIVE PAYMENT conjunction with the remainder of this of this chapter); SYSTEM FOR HOSPITAL OUTPATIENT document, demonstrate that this final (iii) It was medically appropriate to DEPARTMENT SERVICES rule with comment period is consistent have collected the sample from the with the regulatory philosophy and hospital outpatient during the hospital ■ 5. The authority citation for part 419 principles identified in Executive Order outpatient encounter; continues to read as follows:
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Authority: Secs. 1102, 1833(t), and 1871 during the first calendar quarter of the § 419.71 Payment reduction for certain X- of the Social Security Act (42 U.S.C. 1302, year prior to the affected annual ray imaging services. 1395l(t), and 1395hh). payment update. (a) Definition. For purposes of this ■ 6. Section 419.32 is amended by (ii) Hospitals that did not participate section, the term ‘‘computed adding paragraph (b)(1)(iv)(B)(9) to read in the previous year’s Hospital OQR radiography technology’’ means as follows: Program must follow data submission cassette-based imaging which utilizes an deadlines as specified in paragraph imaging plate to create the image § 419.32 Calculation of prospective (c)(2) of this section. payment rates for hospital outpatient involved. services. * * * * * (d) Exception. CMS may grant an (b) Payment reduction for film X-ray * * * * * exception to one or more data imaging services. For an imaging service (b) * * * submission deadlines and requirements that is an X-ray taken using film and (1) * * * in the event of extraordinary that is furnished during 2017 or a (iv) * * * circumstances beyond the control of the subsequent year, the payment amount (B) * * * hospital, such as when an act of nature for such service (including the X-ray (9) For calendar year 2018, a affects an entire region or locale or a component of a packaged service) is multiproductivity adjustment (as systemic problem with one of CMS’ data reduced by 20 percent. determined by CMS) and 0.75 collection systems directly or indirectly (c) Payment reduction for computed percentage point. affects data submission. CMS may grant radiography imaging services. The * * * * * an exception as follows: payment amount for an imaging service ■ 7. Section 419.46 is amended— (1) Upon request by the hospital. that is an X-ray taken using computed ■ a. In paragraph (a)(1) by removing the Specific requirements for submission of radiography technology (including the phrase ‘‘Web site’’ and adding in its a request for an exception are available X-ray component of a packaged service) place the term ‘‘Web site’’. on the QualityNet Web site. is reduced by— ■ b. In paragraphs (b) and (c)(2) by (2) At the discretion of CMS. CMS (1) 7 percent, for such services may grant exceptions to hospitals that removing the phrase ‘‘Web site’’ and furnished in CY 2018, 2019, 2020, 2021, have not requested them when CMS adding in its place the term ‘‘Web site’’. or 2022. ■ c. By revising paragraphs (c)(3)(i) and determines that an extraordinary circumstance has occurred. (2) 10 percent, for such services (ii) and (d). furnished in CY 2023 or a subsequent ■ d. By adding paragraph (e)(3). (e) * * * (3) CMS will select a random sample calendar year. ■ e. In paragraphs (f)(1) and (g)(2) by of 450 hospitals for validation purposes, removing the phrase ‘‘Web site’’ and (d) Application without regard to and will select an additional 50 adding in its place the term ‘‘Web site’’ budget neutrality. The reductions taken hospitals for validation purposes based wherever it appears. under this section are not considered on the following criteria: adjustments under section 1833(t)(2)(E) The revisions and additions read as (i) The hospital fails the validation follow: of the Act and are not implemented in requirement that applies to the previous a budget neutral manner. § 419.46 Participation, data submission, year’s payment determination; or Dated: October 26, 2017. and validation requirements under the (ii) The hospital has an outlier value Hospital Outpatient Quality Reporting for a measure based on the data it Seema Verma, (OQR) Program. submits. An ‘‘outlier value’’ is a Administrator, Centers for Medicare and * * * * * measure value that is greater than 5 Medicaid Services. (c) * * * standard deviations from the mean of Dated: October 30, 2017. (3) * * * the measure values for other hospitals, Eric D. Hargan, (i) Hospitals that did not participate and indicates a poor score. Acting Secretary, Department of Health and in the previous year’s Hospital OQR * * * * * Human Services. Program must initially submit data ■ 8. Section 419.71 is added to read as [FR Doc. 2017–23932 Filed 11–1–17; 4:15 pm] beginning with encounters occurring follows: BILLING CODE 4120–01–P
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Part III
The President
Proclamation 9672—Veterans Day, 2017
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Federal Register Presidential Documents Vol. 82, No. 217
Monday, November 13, 2017
Title 3— Proclamation 9672 of November 7, 2017
The President Veterans Day, 2017
By the President of the United States of America
A Proclamation Our veterans represent the very best of America. They have bravely answered the call to serve in the finest military force in the world, and they have earned the dignity that comes with wearing the uniform and defending our great flag. On Veterans Day, we honor all Americans who have served in the Army, Navy, Air Force, Marines, and Coast Guard, both in times of war and peace. For nearly 100 years, since the end of World War I, Veterans Day has given us a time to pay due respect to our veterans, who have passed the torch of liberty from one generation to the next. Part of paying our respect means recommitting to our Nation’s sacred obliga- tion to care for those who have protected the freedom we often take for granted. I have pledged to provide our service members with the best equip- ment, resources, and support in the world—support that must continue after they return to civilian life as veterans. This is why veterans’ healthcare is a top priority for my Administration. I have signed legislation that improves accountability at the Department of Veterans Affairs (VA) and provides additional funding for the Veterans Choice Program, which ensures veterans continue to receive care in their communities from providers they trust. I have also signed legislation to give veterans GI Bill education benefits for their lifetime, and legislation to fix the VA appeals process, to ensure veterans can access the resources they are rightly due. Additionally, this Veterans Day, more than 50 years from the beginning of the Vietnam War, I will be in Da Nang, Vietnam, with leaders of the Asia-Pacific Economic Cooperation forum. As we discuss ways to improve economic relationships between the United States and Asia in a country where Americans and Vietnamese once fought a war, we are compelled to recall and recognize the sacrifices of the more than 8 million Vietnam veterans who served here, beginning with those who arrived in the first American troop deployment in 1965 and ending with those who fought through the cease-fire of 1973. These men and women dedicated themselves, during one of the most challenging periods in our history, to promoting freedom across the globe. Many spent years away from their loved ones as they endured the burdens of battle and some experienced profound pain and anguish as their fellow warriors, more than 50,000 of them, lost their lives. Some of these heroes have yet to return home, as 1,253 of America’s sons and daughters still remain missing. Along with our Vietnamese partners, however, we continue to work to account for them and to bring them home to American soil. We will not rest until that work is done. With respect for, and in recognition of, the contributions our service members have made to the cause of peace and freedom around the world, the Congress has provided (5 U.S.C. 6103(a)) that November 11 of each year shall be set aside as a legal public holiday to honor our Nation’s veterans. As Com- mander in Chief of our heroic Armed Forces, I humbly thank our veterans and their families as we remember and honor their service and their sacrifice. NOW, THEREFORE, I, DONALD J. TRUMP, President of the United States of America, do hereby proclaim November 11, 2017, as Veterans Day. I encourage all Americans to recognize the fortitude and sacrifice of our
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veterans through public ceremonies and private thoughts and prayers. I call upon Federal, State, and local officials to display the flag of the United States and to participate in patriotic activities in their communities. I call on all Americans, including civic and fraternal organizations, places of wor- ship, schools, and communities to support this day with commemorative expressions and programs. IN WITNESS WHEREOF, I have hereunto set my hand this seventh day of November, in the year of our Lord two thousand seventeen, and of the Independence of the United States of America the two hundred and forty-second.
[FR Doc. 2017–24689 Filed 11–9–17; 11:15 am] Billing code 3295–F8–P
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Reader Aids Federal Register Vol. 82, No. 217 Monday, November 13, 2017
CUSTOMER SERVICE AND INFORMATION CFR PARTS AFFECTED DURING NOVEMBER
Federal Register/Code of Federal Regulations At the end of each month the Office of the Federal Register General Information, indexes and other finding 202–741–6000 publishes separately a List of CFR Sections Affected (LSA), which aids lists parts and sections affected by documents published since Laws 741–6000 the revision date of each title. 14 CFR Presidential Documents 2 CFR Executive orders and proclamations 741–6000 Ch. IX...... 50491 21...... 51549, 51550 25 ...... 50496, 50500, 50502 The United States Government Manual 741–6000 3 CFR 39 ...... 51335, 51338, 51340, Other Services Proclamations: 51552, 51979 Electronic and on-line services (voice) 741–6020 9665...... 51535 71 ...... 50502, 50503, 50504, Privacy Act Compilation 741–6050 9666...... 51537 50505, 50506, 50508, 50509, Public Laws Update Service (numbers, dates, etc.) 741–6043 9667...... 51539 50510, 51342, 51756 9668...... 51541 73...... 51344 9669...... 51543 95...... 51981 ELECTRONIC RESEARCH 9670...... 51547 Proposed Rules: Ch. I ...... 51178 World Wide Web 9671...... 51965 9672...... 52641 25...... 50581 Full text of the daily Federal Register, CFR and other publications Administrative Orders: 27...... 50583 is located at: www.fdsys.gov. Notices: 29...... 50583 39 ...... 50847, 50849, 51170, Federal Register information and research tools, including Public Notice of October 31, 2017 ...... 50799 51172, 51175, 51364, 51367, Inspection List, indexes, and Code of Federal Regulations are 51583, 51782, 52015, 52022 located at: www.ofr.gov. Notice of November 6, 2017 ...... 51967 71 ...... 50593, 50594, 50596 E-mail Notice of November 6, Ch. II ...... 51178 2017 ...... 51969 Ch. III ...... 51178 FEDREGTOC (Daily Federal Register Table of Contents Electronic Notice of November 6, 15 CFR Mailing List) is an open e-mail service that provides subscribers 2017 ...... 51971 with a digital form of the Federal Register Table of Contents. The 740...... 50511, 51983 digital form of the Federal Register Table of Contents includes 4 CFR 746...... 51983 HTML and PDF links to the full text of each document. 81...... 51753 16 CFR To join or leave, go to https://public.govdelivery.com/accounts/ USGPOOFR/subscriber/new, enter your email address, then 5 CFR Proposed Rules: follow the instructions to join, leave, or manage your 532...... 50801 305...... 52024 subscription. Ch. XXIII ...... 50491 17 CFR PENS (Public Law Electronic Notification Service) is an e-mail 5601...... 50493 service that notifies subscribers of recently enacted laws. 9801...... 51333 Proposed Rules: Proposed Rules: 229...... 50988 To subscribe, go to http://listserv.gsa.gov/archives/publaws-l.html 890...... 51170 230...... 50988 and select Join or leave the list (or change settings); then follow 232...... 50988 the instructions. 7 CFR 239...... 50988 FEDREGTOC and PENS are mailing lists only. We cannot 1...... 51149 240...... 50988 respond to specific inquiries. 301...... 50801 249...... 50988 270...... 50988 Reference questions. Send questions and comments about the 4279...... 50802 274...... 50988 Federal Register system to: [email protected] Proposed Rules: 340...... 51582 275...... 50988 The Federal Register staff cannot interpret specific documents or 3419...... 52250 regulations. 18 CFR CFR Checklist. Effective January 1, 2009, the CFR Checklist no 10 CFR Ch. I ...... 50517 longer appears in the Federal Register. This information can be Ch. II ...... 50491 1301...... 51757 found online at http://bookstore.gpo.gov/. Ch. III ...... 50491 Ch. X...... 50491 19 CFR FEDERAL REGISTER PAGES AND DATE, NOVEMBER Proposed Rules: 24...... 50523 30...... 51363 111...... 50523 50491–50798...... 1 431...... 50844 20 CFR 50799–51148...... 2 12 CFR 51149–51332...... 3 1011...... 52186 34...... 51973 51333–51548...... 6 21 CFR 51549–51752...... 7 204...... 51754 209...... 52173 1...... 51345 51735–51972...... 8 213...... 51975 73...... 51554 51973–52172...... 9 226...... 51973, 51977 117...... 51345 52173–52642...... 13 1013...... 51975 507...... 51345 1026...... 51973, 51977 573...... 52207 862...... 51558 13 CFR 866 ...... 50530, 51560, 51567 107...... 52174 1308...... 51154
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Proposed Rules: 52004, 52005, 52210 414...... 50738, 52356 9...... 51527, 51773 11...... 52036 165 ...... 50578, 51347, 51767, 416...... 52356 17...... 51527, 51773 73...... 52037 52005, 52007, 52210, 52212 419...... 52356 22 ...... 51358, 51527, 51773 101...... 52036 484...... 51676 42...... 51526, 51773 573...... 50598 36 CFR 52 ...... 51358, 51527, 51773 880...... 51585 Ch. I ...... 50532 43 CFR Ch. 9 ...... 50491 Ch. II ...... 50580 Subtitle A ...... 50532 Proposed Rules: 23 CFR Subtitle B ...... 50532 Ch. 12 ...... 51178 Proposed Rules: 37 CFR 45 CFR Ch. I ...... 51178 42...... 51570 49 CFR 490...... 51786 201...... 52213, 52221 Proposed Rules: 40...... 52229 Ch. II ...... 51178 202...... 52224 147...... 51052 Ch. III ...... 51178 Proposed Rules: 153...... 51052 Proposed Rules: 201...... 51369, 52258 154...... 51052 Ch. I ...... 51178 25 CFR 202...... 51369, 52258 155...... 51052 Ch. II ...... 51178 Ch. I ...... 50532 381...... 51589 156...... 51052 Ch. III ...... 51178 Ch. II ...... 50532 157...... 51052 Ch. V...... 51178 Ch. III ...... 50532 38 CFR 158...... 51052 Ch. VI...... 51178 Ch. V...... 50532 4...... 50802 Ch. VII...... 51178 Ch. VI...... 50532 17...... 51770 46 CFR Ch. VIII...... 51178 Ch. VII...... 50532 61...... 51158 Proposed Rules: Ch. X...... 51178 Proposed Rules: 62...... 51158 Ch. II ...... 51178 Ch. XI...... 51178 514...... 52253 40 CFR 47 CFR 50 CFR 29 CFR Ch. I ...... 51160 2...... 50820 Ch. I ...... 50532 1926...... 51986 52 ...... 50580, 50807, 50811, 15...... 50820 20...... 51538 50814, 51349, 51575 18...... 50820 32...... 51940, 52009 30 CFR 62...... 51350 73...... 50820, 51178 36...... 52009 Ch. II ...... 50532 97...... 50580 74...... 50820 Ch. IV...... 50532 Ch. IV...... 50532 180...... 51351, 51355 78...... 50820 622 ...... 50839, 51577, 51777, Ch. V...... 50532 Proposed Rules: 80...... 50820 52248 Ch. VII...... 50532 52 ...... 50851, 50853, 51178, 87...... 50820 648 ...... 51578, 51778, 52249 Ch. XII...... 50532 51594, 52259 90...... 50820 660...... 51166 60 ...... 51787, 51788, 51794 101...... 50820 679...... 51168, 52011 31 CFR 62...... 51380 Proposed Rules: 680...... 52011 515...... 51998 63...... 51380 1...... 50598 Proposed Rules: 543...... 52209 54...... 51180 Ch. I ...... 51382 1010...... 51758 41 CFR 17...... 50606, 52262 Ch. 109 ...... 50491 48 CFR 224...... 51186 33 CFR Ch. 1 ...... 51526 226...... 51186 100...... 50575, 51765 42 CFR 1...... 51527, 51773 648...... 51492, 51594 117 ...... 50577, 51158, 51766, 413...... 50738 4...... 51527, 51773 660...... 51381
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