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38330 Federal Register / Vol. 84, No. 151 / Tuesday, August 6, 2019 / Proposed Rules DEPARTMENT OF HEALTH AND PPS wage index, and new requirements a comment. We post all comments HUMAN SERVICES for the competitive bidding of diabetic received before the close of the testing strips. comment period on the following Centers for Medicare & Medicaid DATES: To be assured consideration, website as soon as possible after they Services comments must be submitted at one of have been received: http:// the addresses provided below, no later www.regulations.gov. Follow the search 42 CFR Parts 405, 410, 413 and 414 than September 27, 2019. instructions on that website to view [CMS–1713–P] ADDRESSES: In commenting, please refer public comments. to file code CMS–1713–P. Because of RIN 0938–AT70 Table of Contents staff and resource limitations, we cannot To assist readers in referencing accept comments by facsimile (FAX) Medicare Program; End-Stage Renal sections contained in this preamble, we transmission. Disease Prospective Payment System, are providing a Table of Contents. Some Comments, including mass comment Payment for Renal Dialysis Services of the issues discussed in this preamble submissions, must be submitted in one Furnished to Individuals With Acute affect the payment policies, but do not of the following three ways (please Kidney Injury, End-Stage Renal require changes to the regulations in the choose only one of the ways listed): Disease Quality Incentive Program, Code of Federal Regulations (CFR). Durable Medical Equipment, 1. Electronically. You may submit I. Executive Summary Prosthetics, Orthotics and Supplies electronic comments on this regulation to http://www.regulations.gov. Follow A. Purpose (DMEPOS) Fee Schedule Amounts, B. Summary of the Major Provisions DMEPOS Competitive Bidding (CBP) the ‘‘Submit a comment’’ instructions. 2. By regular mail. You may mail C. Summary of Cost and Benefits Proposed Amendments, Standard II. Calendar Year (CY) 2020 End-Stage Renal Elements for a DMEPOS Order, and written comments to the following Disease (ESRD) Prospective Payment Master List of DMEPOS Items address ONLY: Centers for Medicare & System (PPS) Potentially Subject to a Face-to-Face Medicaid Services, Department of A. Background Encounter and Written Order Prior to Health and Human Services, Attention: B. Provisions of the Proposed Rule CMS–1713–P, P.O. Box 8010, Baltimore, III. CY 2020 Payment for Renal Dialysis Delivery and/or Prior Authorization Services Furnished to Individuals With Requirements MD 21244–8010. Please allow sufficient time for mailed Acute Kidney Injury (AKI) A. Background AGENCY: comments to be received before the Centers for Medicare & B. Proposed Annual Payment Rate Update Medicaid Services (CMS), HHS. close of the comment period. for CY 2020 ACTION: Proposed rule. 3. By express or overnight mail. You IV. End-Stage Renal Disease Quality may send written comments to the Incentive Program (ESRD QIP) SUMMARY: This proposed rule would following address ONLY: Centers for A. Background and Proposed Regulation update and make revisions to the End- Medicare & Medicaid Services, Text Update Stage Renal Disease (ESRD) Prospective Department of Health and Human B. Proposed Update to Requirements Payment System (PPS) for calendar year Services, Attention: CMS–1713–P, Mail Beginning With the PY 2022 ESRD QIP (CY) 2020. This rule also proposes to Stop C4–26–05, 7500 Security C. Proposals for the PY 2023 ESRD QIP Boulevard, Baltimore, MD 21244–1850. V. Establishing Payment Amounts for New update the payment rate for renal Durable Medical Equipment, Prosthetics, dialysis services furnished by an ESRD For information on viewing public Orthotics and Supplies (DMEPOS) Items facility to individuals with acute kidney comments, see the beginning of the and Services (Gap-Filling) injury (AKI). This proposed rule also SUPPLEMENTARY INFORMATION section. A. Background proposes to update requirements for the FOR FURTHER INFORMATION CONTACT: B. Current Issues ESRD Quality Incentive Program (QIP). [email protected], for C. Provisions of the Proposed Rule In addition, this rule proposes a issues related to the ESRD PPS and VI. Standard Elements for a Durable Medical methodology for calculating fee coverage and payment for renal dialysis Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Order; Master List schedule payment amounts for new services furnished to individuals with of DMEPOS Items Potentially Subject to Durable Medical Equipment, AKI. a Face-to-Face Encounter and Written Prosthetics, Orthotics and Supplies Delia Houseal, (410) 786–2724, for Order Prior to Delivery and/or Prior (DMEPOS) items and services and issues related to the ESRD QIP. Authorization Requirements making adjustments to the fee schedule [email protected], for issues A. Background amounts established using supplier or related to DMEPOS payment policy. B. Provisions of the Proposed Regulations commercial prices if such prices Julia Howard, (410) 786–8645, for VII. DMEPOS Competitive Bidding Program decrease within 5 years of establishing issues related to DMEPOS CBP (CBP) Amendments the initial fee schedule amounts. This Amendments A. Background Jennifer Phillips, (410) 786–1023; B. Proposed Amendments rule also proposes to revise existing VIII. Requests for Information regulations related to the competitive Olufemi Shodeke, (410) 786–1649; A. Data Collection bidding program for DMEPOS. This Maria Ciccanti, (410) 786–3107; and B. Wage Index Comment Solicitation proposed rule also would streamline the Emily Calvert, (410) 786–4277, for C. Comment Solicitation on Sources of requirements for ordering DMEPOS issues related to the DMEPOS written Market-Based Data Measuring Sales of items, and develop a new list of order, face-to-face encounter, and prior Diabetic Testing Strips to Medicare DMEPOS items potentially subject to a authorization requirements. Beneficiaries (Section 50414 of the face-to-face encounter, written orders SUPPLEMENTARY INFORMATION: Bipartisan Budget Act of 2018) prior to delivery and/or prior Inspection of Public Comments: All IX. Collection of Information Requirements A. Legislative Requirement for Solicitation authorization requirements. Finally, this comments received before the close of of Comments proposed rule includes requests for the comment period are available for B. Requirements in Regulation Text information on data collection resulting viewing by the public, including any C. Additional Information Collection from the ESRD PPS technical expert personally identifiable or confidential Requirements panel, changing the basis for the ESRD business information that is included in X. Response to Comments VerDate Sep<11>2014 18:36 Aug 05, 2019 Jkt 247001 PO 00000 Frm 00002 Fmt 4701 Sfmt 4702 E:\FR\FM\06AUP2.SGM 06AUP2 jbell on DSK3GLQ082PROD with PROPOSALS2 Federal Register / Vol. 84, No. 151 / Tuesday, August 6, 2019 / Proposed Rules 38331 XI. Economic Analyses 2. Coverage and Payment for Renal 5. Conditions of Payment To Be Applied A. Regulatory Impact Analysis Dialysis Services Furnished to to the Proposed Master List of DMEPOS B. Detailed Economic Analysis Individuals With Acute Kidney Injury Items C. Accounting Statement (AKI) D. Regulatory Flexibility Act Analysis This proposed rule would streamline E Unfunded Mandates Reform Act On June 29, 2015, the President the requirements for ordering DMEPOS Analysis signed the Trade Preferences Extension items. It would also develop one Master F. Federalism Analysis Act of 2015 (TPEA) (Pub. L. 114–27). List of DMEPOS items potentially G. Reducing Regulation and Controlling Section 808(a) of TPEA amended subject to a face-to-face encounter, Regulatory Costs section 1861(s)(2)(F) of the Act to written orders prior to delivery and/or H. Congressional Review Act provide coverage for renal dialysis prior authorization requirements under XII. Files Available to the Public via the services furnished on or after January 1, the authority provided under sections Internet 2017, by a renal dialysis facility or a 1834(a)(1)(E)(iv), 1834(a)(11)(B), and Regulations Text provider of services paid under section 1834(a)(15) of the Act. I. Executive Summary 1881(b)(14) of the Act to an individual B. Summary of the Major Provisions with acute kidney injury (AKI). Section A. Purpose 808(b) of the TPEA amended section 1. ESRD PPS 1834 of the Act by adding a new • Update to the ESRD PPS base rate This proposed rule contains proposals subsection (r) that provides for payment for CY 2020: The proposed CY 2020 related to the End-Stage Renal Disease for renal dialysis services furnished by ESRD PPS base rate is $240.27. This (ESRD) Prospective Payment System renal dialysis facilities or providers of proposed amount reflects a (PPS), payment for renal dialysis services paid under section 1881(b)(14) productivity-adjusted market basket services furnished to individuals with of the Act to individuals with AKI at the increase as required by section acute kidney injury (AKI), the ESRD ESRD PPS base rate beginning January 1881(b)(14)(F)(i)(I) of the Act (1.7 Quality Incentive Program (QIP), the 1, 2017. This rule proposes to update percent), and application of the wage Durable Medical Equipment, the AKI payment rate for CY 2020. index budget-neutrality adjustment Prosthetics, Orthotics and Supplies factor (1.004180), equaling $240.27 (DMEPOS) Fee Schedule Amounts, 3. End-Stage Renal Disease Quality × × Incentive Program (ESRD QIP) ($235.27 1.017 1.004180 = $240.27). DMEPOS Competitive Bidding Program