Final Rule for PFS Diabetes Prevention Program Model; Issues Related to Therapy

80170 Federal Register / Vol. 81, No. 220 / Tuesday, November 15, 2016 / Rules and Regulations

DEPARTMENT OF HEALTH AND care management (CCM), burden Rabia Khan or Terri Postma, (410) HUMAN SERVICES reduction, telehealth services and 786–8084 or [email protected], for evaluation and management services. issues related to the Medicare Shared Centers for Medicare & Medicaid Emily Yoder, (410) 786–1804, for Savings Program. Services issues related to resource intensive Kimberly Spalding Bush, (410) 786– services, telehealth services and other 3232, or Fiona Larbi, (410) 786–7224, 42 CFR Parts 405, 410, 411, 414, 417, primary care issues. for issues related to Value-based 422, 423, 424, 425, and 460 Lindsey Baldwin, (410) 786–1694, for Payment Modifier and Physician primary care issues related to behavioral [CMS–1654–F] Feedback Program. health integration services. RIN 0938–AS81 Geri Mondowney, (410) 786–4584, Lisa Ohrin Wilson, (410) 786–8852, or and Donta Henson, (410) 786–1947, for Gabriel Scott, (410) 786–3928, for issues Medicare Program; Revisions to issues related to geographic practice related to physician self-referral Payment Policies Under the Physician cost indices. updates. Fee Schedule and Other Revisions to Michael Soracoe, (410) 786–6312, for SUPPLEMENTARY INFORMATION: Part B for CY 2017; Medicare issues related to the target and phase-in Advantage Bid Pricing Data Release; provisions, the practice expense Table of Contents Medicare Advantage and Part D methodology, impacts, conversion I. Executive Summary and Background Medical Loss Ratio Data Release; factor, and the valuation of pathology A. Executive Summary Medicare Advantage Provider Network and surgical procedures. B. Background Requirements; Expansion of Medicare Pamela West, (410) 786–2302, for II. Provisions of the Final Rule for PFS Diabetes Prevention Program Model; issues related to therapy. A. Determination of Practice Expense Medicare Shared Savings Program Patrick Sartini, (410) 786–9252, for Relative Value Units (PE RVUs) Requirements issues related to malpractice RVUs, B. Determination of Malpractice Relative radiation treatment, mammography and Value Units (MRVUs) AGENCY: Centers for Medicare & other imaging services. C. Medicare Telehealth Services Medicaid Services (CMS), HHS. Kathy Bryant, (410) 786–3448, for D. Potentially Misvalued Services Under ACTION: Final rule. issues related to collecting data on the Physician Fee Schedule 1. Background resources used in furnishing global SUMMARY: This major final rule 2. Progress in Identifying and Reviewing addresses changes to the physician fee services. Potentially Misvalued Codes Donta Henson, (410) 786–1947, for schedule and other Medicare Part B 3. Validating RVUs of Potentially issues related to ophthalmology payment policies, such as changes to the Misvalued Codes services. Value Modifier, to ensure that our 4. CY 2017 Identification and Review of Corinne Axelrod, (410) 786–5620, for Potentially Misvalued Services payment systems are updated to reflect issues related to rural health clinics or 5. Valuing Services That Include Moderate changes in medical practice and the federally qualified health centers. Sedation as an Inherent Part of relative value of services, as well as Simone Dennis, (410) 786–8409, for Furnishing the Procedure changes in the statute. This final rule issues related to FQHC-specific market 6. Collecting Data on Resources Used in also includes changes related to the basket. Furnishing Global Services Medicare Shared Savings Program, JoAnna Baldwin, (410) 786–7205, or E. Improving Payment Accuracy for requirements for Medicare Advantage Sarah Fulton, (410) 786–2749, for issues Primary Care, Care Management Provider Networks, and provides for the Services, and Patient-Centered Services related to appropriate use criteria for F. Improving Payment Accuracy for release of certain pricing data from advanced diagnostic imaging services. Medicare Advantage bids and of data Services: Diabetes Self-Management Robin Usi, (410) 786–0364, for issues Training (DSMT) from medical loss ratio reports related to open payments. G. Target for Relative Value Adjustments submitted by Medicare health and drug Sean O’Grady, (410) 786–2259, or for Misvalued Services plans. In addition, this final rule Julie Uebersax, (410) 786–9284, for H. Phase-In of Significant RVU Reductions expands the Medicare Diabetes issues related to release of pricing data I. Geographic Practice Cost Indices (GPCIs) Prevention Program model. from Medicare Advantage bids and J. Payment Incentive for the Transition DATES: These regulations are effective release of medical loss ratio data From Traditional X-Ray Imaging to on January 1, 2017. submitted by Medicare Advantage Digital Radiography and Other Imaging Services FOR FURTHER INFORMATION CONTACT: organizations and Part D sponsors. Sara Vitolo, (410) 786–5714, for issues K. Procedures Subject to the Multiple Jessica Bruton, (410) 786–5991, for Procedure Payment Reduction (MPPR) issues related to identification of related to prohibition on billing and the OPPS Cap potentially misvalued services and any qualified Medicare beneficiary L. Valuation of Specific Codes physician payment issues not identified individuals for Medicare cost-sharing. M. Therapy Caps below. Michelle Peterman, (410) 786–2591, III. Other Provisions of the Final Rule for PFS Gail Addis, (410) 786–4522, for issues for issues related to Accountable Care A. Chronic Care Management (CCM) and related to diabetes self-management Organization (ACO) participants who Transitional Care Management (TCM) training. report PQRS quality measures Supervision Requirements in Rural Jaime Hermansen, (410) 786–2064, for separately. Health Clinics (RHCs) and Federally issues related to moderate sedation Katie Mucklow, (410) 786–0537 or Qualified Health Centers (FQHCs) coding and anesthesia services. John Spiegel, (410) 786–1909, for issues B. FQHC-Specific Market Basket Roberta Epps, (410) 786–4503, for related to Provider Enrollment Medicare C. Appropriate Use Criteria for Advanced Advantage Program. Diagnostic Imaging Services issues related to PAMA section 218(a) D. Reports of Payments or Other Transfers policy and the transition from Jen Zhu, (410) 786–3725, Carlye Burd, of Value to Covered Recipients: traditional x-ray imaging to digital (410) 786–1972, or Nina Brown, (410) Summary of Public Comments radiography. 786–6103, for issues related to Medicare E. Release of Part C Medicare Advantage Ann Marshall, (410) 786–3059, for Diabetes Prevention Program model Bid Pricing Data and Part C and Part D primary care issues related to chronic expansion. Medical Loss Ratio (MLR) Data

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F. Prohibition on Billing Qualified DM Diabetes mellitus OBRA ’90 Omnibus Budget Reconciliation Medicare Beneficiary Individuals for DSMT Diabetes self-management training Act of 1990 (Pub. L. 101–508) Medicare Cost-Sharing eCQM Electronic clinical quality measures OES Occupational Employment Statistics G. Recoupment or Offset of Payments to ED Emergency Department OMB Office of Management and Budget Providers Sharing the Same Taxpayer EHR Electronic health record OPPS Outpatient prospective payment Identification Number E/M Evaluation and management system H. Accountable Care Organization (ACO) EMT Emergency Medical Technician OT Occupational therapy Participants Who Report Physician EP Eligible professional PA Physician assistant Quality Reporting System (PQRS) eRx Electronic prescribing PAMA Protecting Access to Medicare Act of Quality Measures Separately ESRD End-stage renal disease 2014 (Pub. L. 113–93) I. Medicare Advantage Provider Enrollment FAR Federal Acquisition Regulations PAMPA Patient Access and Medicare J. Expansion of the Diabetes Prevention FDA Food and Drug Administration Protection Act (Pub. L. 114–115) Program (DPP) Model FFS Fee-for-service PC Professional component K. Medicare Shared Savings Program FQHC Federally qualified health center PCIP Primary Care Incentive Payment L. Value-Based Payment Modifier and FR Federal Register PE Practice expense Physician Feedback Program FSHCAA Federally Supported Health PE/HR Practice expense per hour M. Physician Self-Referral Updates Centers Assistance Act PEAC Practice Expense Advisory N. Designated Health Services GAF Geographic adjustment factor Committee IV. Collection of Information Requirements GAO Government Accountability Office PECOS Provider Enrollment, Chain, and V. Regulatory Impact Analysis GPCI Geographic practice cost index Ownership System Regulations Text GPO Group purchasing organization PFS Physician Fee Schedule GPRO Group practice reporting option PLI Professional Liability Insurance Acronyms GTR Genetic Testing Registry PMA Premarket approval In addition, because of the many HCPCS Healthcare Common Procedure PPM Provider-Performed Microscopy organizations and terms to which we Coding System PQRS Physician Quality Reporting System refer by acronym in this final rule, we HHS [Department of] Health and Human PPIS Physician Practice Expense Information Survey are listing these acronyms and their Services HOPD Hospital outpatient department PPS Prospective Payment System corresponding terms in alphabetical HPSA Health professional shortage area PT Physical therapy order below: IDTF Independent diagnostic testing facility PT Proficiency Testing A1c Hemoglobin A1c IPPE Initial preventive physical exam PT/INR Prothrombin Time/International AAA Abdominal aortic aneurysms IPPS Inpatient Prospective Payment System Normalized Ratio ACO Accountable care organization IQR Inpatient Quality Reporting PY Performance year AMA American Medical Association ISO Insurance service office QA Quality Assessment ASC Ambulatory surgical center IT Information technology QC Quality Control ATA American Telehealth Association IWPUT Intensity of work per unit of time QCDR Qualified clinical data registry ATRA American Taxpayer Relief Act (Pub. LCD Local coverage determination QRUR Quality and Resources Use Report L. 112–240) MA Medicare Advantage RBRVS Resource-based relative value scale AWV Annual wellness visit MAC Medicare Administrative Contractor RFA Regulatory Flexibility Act BBA Balanced Budget Act of 1997 (Pub. L. MACRA Medicare Access and CHIP RHC Rural health clinic 105–33) Reauthorization Act of 2015 (Pub. L. 114– RIA Regulatory impact analysis BBRA [Medicare, Medicaid and State Child 10) RUC American Medical Association/ Health Insurance Program] Balanced MAP Measure Applications Partnership Specialty Society Relative (Value) Update Budget Refinement Act of 1999 (Pub. L. MAPCP Multi-payer Advanced Primary Committee 106–113) Care Practice RUCA Rural Urban Commuting Area BLS Bureau of Labor Statistics MAV Measure application validity RVU Relative value unit CAD Coronary artery disease [process] SBA Small Business Administration CAH Critical access hospital MCP Monthly capitation payment SGR Sustainable growth rate CBSA Core-Based Statistical Area MedPAC Medicare Payment Advisory SIM State Innovation Model CCM Chronic care management Commission SLP Speech-language pathology CEHRT Certified EHR technology MEI Medicare Economic Index SMS Socioeconomic Monitoring System CF Conversion factor MFP Multi-Factor Productivity SNF Skilled nursing facility CG–CAHPS Clinician and Group Consumer MIPPA Medicare Improvements for Patients TAP Technical Advisory Panel Assessment of Healthcare Providers and and Providers Act (Pub. L. 110–275) TC Technical component Systems MMA Medicare Prescription Drug, TIN Tax identification number CLFS Clinical Laboratory Fee Schedule Improvement and Modernization Act of TCM Transitional Care Management CoA Certificate of Accreditation 2003 (Pub. L. 108–173, enacted on UAF Update adjustment factor CoC Certificate of Compliance December 8, 2003) UPIN Unique Physician Identification CoR Certificate of Registration MP Malpractice Number CNM Certified nurse-midwife MPPR Multiple procedure payment USPSTF United States Preventive Services CP Clinical psychologist reduction Task Force CPC Comprehensive Primary Care MRA Magnetic resonance angiography VBP Value-based purchasing CPEP Clinical Practice Expert Panel MRI Magnetic resonance imaging VM Value-Based Payment Modifier CPT [Physicians] Current Procedural MSA Metropolitan Statistical Areas Terminology (CPT codes, descriptions and MSPB Medicare Spending per Beneficiary Addenda Available Only Through the other data only are copyright 2015 MU Meaningful use Internet on the CMS Web Site American Medical Association. All rights NCD National coverage determination The PFS Addenda along with other reserved.) NCQDIS National Coalition of Quality supporting documents and tables CQM Clinical quality measure Diagnostic Imaging Services referenced in this final rule are available CSW Clinical social worker NP Nurse practitioner through the Internet on the CMS Web CT Computed tomography NPI National Provider Identifier CW Certificate of Waiver NPP Nonphysician practitioner site at http://www.cms.gov/Medicare/ CY Calendar year NQS National Quality Strategy Medicare-Fee-for-Service-Payment/ DFAR Defense Federal Acquisition OACT CMS’s Office of the Actuary PhysicianFeeSched/PFS-Federal- Regulations OBRA ’89 Omnibus Budget Reconciliation Regulation-Notices.html. Click on the DHS Designated health services Act of 1989 (Pub. L. 101–239) link on the left side of the screen titled,

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‘‘PFS Federal Regulations Notices’’ for a rule, we establish RVUs for CY 2017 for distribution of Medicare expenditures. chronological list of PFS Federal the PFS, and other Medicare Part B When considering the combined impact Register and other related documents. payment policies, to ensure that our of work, PE, and MP RVU changes, the For the CY 2017 PFS Final Rule, refer payment systems are updated to reflect projected payment impacts would be to item CMS–1654–F. Readers who changes in medical practice and the small for most specialties; however, the experience any problems accessing any relative value of services, as well as impact would be larger for a few of the Addenda or other documents changes in the statute. In addition, this specialties. referenced in this rule and posted on the final rule includes summaries of public We have determined that this major CMS Web site identified above should comments and final policies regarding: final rule is economically significant. contact Jessica Bruton at (410) 786– • Potentially Misvalued Codes. For a detailed discussion of the 5991. • Telehealth Services. economic impacts, see section VI. of this • Establishing Values for New, CPT (Current Procedural Terminology) final rule. Revised, and Misvalued Codes. Copyright Notice • Target for Relative Value B. Background Throughout this final rule, we use Adjustments for Misvalued Services. Since January 1, 1992, Medicare has CPT codes and descriptions to refer to • Phase-in of Significant RVU paid for physicians’ services under a variety of services. We note that CPT Reductions. section 1848 of the Social Security Act codes and descriptions are copyright • Chronic Care Management (CCM) (the Act), ‘‘Payment for Physicians’ 2015 American Medical Association. All and Transitional Care Management Services.’’ The PFS relies on national Rights Reserved. CPT is a registered (TCM) Supervision Requirements in relative values that are established for trademark of the American Medical Rural Health Clinics (RHCs) and work, PE, and MP, which are adjusted Association (AMA). Applicable Federal Federally Qualified Health Centers for geographic cost variations. These Acquisition Regulations (FAR) and (FQHCs). values are multiplied by a conversion Defense Federal Acquisition Regulations • FQHC-Specific Market Basket. factor (CF) to convert the RVUs into (DFAR) apply. • Appropriate Use Criteria for payment rates. The concepts and Advanced Diagnostic Imaging Services. methodology underlying the PFS were I. Executive Summary and Background • Reports of Payments or Other enacted as part of the Omnibus Budget A. Executive Summary Transfers of Value to Covered Reconciliation Act of 1989 (Pub. L. 101– 1. Purpose Recipients: Solicitation of Public 239, enacted on December 19, 1989) Comments. (OBRA ’89), and the Omnibus Budget This major final rule revises payment • Release of Part C Medicare Reconciliation Act of 1990 (Pub. L. 101– polices under the Medicare Physician Advantage Bid Pricing Data and Part C 508, enacted on November 5, 1990) Fee Schedule (PFS) and makes other and Part D Medical Loss Ratio (MLR) (OBRA ’90). The final rule published on policy changes related to Medicare Part Data. November 25, 1991 (56 FR 59502) set B payment. These changes will be • Prohibition on Billing Qualified forth the first fee schedule used for applicable to services furnished in CY Medicare Beneficiary Individuals for payment for physicians’ services. 2017. In addition, this final rule Medicare Cost-Sharing. We note that throughout this major includes the following provisions: • Recoupment or Offset of Payments final rule, unless otherwise noted, the Payment policy changes for Rural to Providers Sharing the Same Taxpayer term ‘‘practitioner’’ is used to describe Health Clinics (RHCs) and Federally Identification Number. both physicians and nonphysician Qualified Health Centers (FQHCs); • Accountable Care Organization practitioners (NPPs) who are permitted expansion of the Medicare Diabetes (ACO) Participants Who Report to bill Medicare under the PFS for Prevention Program model; policy Physician Quality Reporting System services furnished to Medicare changes related to the Medicare Shared (PQRS) Quality Measures Separately. beneficiaries. Savings Program; and release of pricing • Medicare Advantage Provider data submitted to CMS by Medicare Enrollment. 1. Development of the Relative Values • Advantage (MA) organizations; and Expansion of the Diabetes a. Work RVUs medical loss ratio reports submitted by Prevention Program (DPP) Model. MA plans and Part D plans. These • Medicare Shared Savings Program. The work RVUs established for the additional policies are addressed in • Value-Based Payment Modifier and initial fee schedule, which was section III. of this final rule. the Physician Feedback Program. implemented on January 1, 1992, were • Physician Self-referral Updates. developed with extensive input from 2. Summary of the Major Provisions • Designated Health Services. the physician community. A research The statute requires us to establish team at the Harvard School of Public payments under the PFS based on 3. Summary of Costs and Benefits Health developed the original work national uniform relative value units The statute requires that annual RVUs for most codes under a (RVUs) that account for the relative adjustments to PFS RVUs may not cause cooperative agreement with the resources used in furnishing a service. annual estimated expenditures to differ Department of Health and Human The statute requires that RVUs be by more than $20 million from what Services (HHS). In constructing the established for three categories of they would have been had the code-specific vignettes used in resources: Work, practice expense (PE); adjustments not been made. If determining the original physician work and malpractice (MP) expense; and, that adjustments to RVUs would cause RVUs, Harvard worked with panels of we establish by regulation each year’s expenditures to change by more than experts, both inside and outside the payment amounts for all physicians’ $20 million, we must make adjustments federal government, and obtained input services paid under the PFS, to preserve budget neutrality. These from numerous physician specialty incorporating geographic adjustments to adjustments can affect the distribution groups. reflect the variations in the costs of of Medicare expenditures across As specified in section 1848(c)(1)(A) furnishing services in different specialties. In addition, several changes of the Act, the work component of geographic areas. In this major final in this final rule will affect the specialty physicians’ services means the portion

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of the resources used in furnishing the 1998 (63 FR 58814), effective for in CY 2007. We adopted a 4-year service that reflects physician time and services furnished in CY 1999. Based on transition to the new PE RVUs. This intensity. We establish work RVUs for the requirement to transition to a transition was completed for CY 2010. new, revised and potentially misvalued resource-based system for PE over a 4- In the CY 2010 PFS final rule with codes based on our review of year period, payment rates were not comment period, we updated the information that generally includes, but fully based upon resource-based PE practice expense per hour (PE/HR) data is not limited to, recommendations RVUs until CY 2002. This resource- that are used in the calculation of PE received from the American Medical based system was based on two RVUs for most specialties (74 FR Association/Specialty Society Relative significant sources of actual PE data: 61749). In CY 2010, we began a 4-year Value Update Committee (RUC), the The Clinical Practice Expert Panel transition to the new PE RVUs using the Health Care Professionals Advisory (CPEP) data; and the AMA’s updated PE/HR data, which was Committee (HCPAC), the Medicare Socioeconomic Monitoring System completed for CY 2013. Payment Advisory Commission (SMS) data. (These data sources are c. Malpractice RVUs (MedPAC), and other public described in greater detail in the CY commenters; medical literature and 2012 final rule with comment period (76 Section 4505(f) of the BBA amended comparative databases; as well as a FR 73033). section 1848(c) of the Act to require that comparison of the work for other codes Separate PE RVUs are established for we implement resource-based MP RVUs within the Medicare PFS, and services furnished in facility settings, for services furnished on or after CY consultation with other physicians and such as a hospital outpatient 2000. The resource-based MP RVUs health care professionals within CMS department (HOPD) or an ambulatory were implemented in the PFS final rule and the federal government. We also surgical center (ASC), and in nonfacility with comment period published assess the methodology and data used to settings, such as a physician’s office. November 2, 1999 (64 FR 59380). The develop the recommendations The nonfacility RVUs reflect all of the MP RVUs are based on commercial and submitted to us by the RUC and other direct and indirect PEs involved in physician-owned insurers’ malpractice public commenters, and the rationale furnishing a service described by a insurance premium data from all the for their recommendations. In the CY particular HCPCS code. The difference, states, the District of Columbia, and 2011 PFS final rule with comment if any, in these PE RVUs generally Puerto Rico. For more information on period (75 FR 73328 through 73329), we results in a higher payment in the MP RVUs, see section II.B.2. of this final discussed a variety of methodologies nonfacility setting because in the facility rule. settings some costs are borne by the and approaches used to develop work d. Refinements to the RVUs RVUs, including survey data, building facility. Medicare’s payment to the blocks, crosswalk to key reference or facility (such as the outpatient Section 1848(c)(2)(B)(i) of the Act similar codes, and magnitude prospective payment system (OPPS) requires that we review RVUs no less estimation. More information on these payment to the HOPD) would reflect often than every 5 years. Prior to CY issues is available in that rule. costs typically incurred by the facility. 2013, we conducted periodic reviews of Thus, payment associated with those work RVUs and PE RVUs b. Practice Expense RVUs facility resources is not made under the independently. We completed five-year Initially, only the work RVUs were PFS. reviews of work RVUs that were resource-based, and the PE and MP Section 212 of the Balanced Budget effective for calendar years 1997, 2002, RVUs were based on average allowable Refinement Act of 1999 (Pub. L. 106– 2007, and 2012. charges. Section 121 of the Social 113, enacted on November 29, 1999) Although refinements to the direct PE Security Act Amendments of 1994 (Pub. (BBRA) directed the Secretary of Health inputs initially relied heavily on input L. 103–432, enacted on October 31, and Human Services (the Secretary) to from the RUC Practice Expense 1994), amended section 1848(c)(2)(C)(ii) establish a process under which we Advisory Committee (PEAC), the shifts of the Act and required us to develop accept and use, to the maximum extent to the bottom-up PE methodology in CY resource-based PE RVUs for each practicable and consistent with sound 2007 and to the use of the updated PE/ physicians’ service beginning in 1998. data practices, data collected or HR data in CY 2010 have resulted in We were required to consider general developed by entities and organizations significant refinements to the PE RVUs categories of expenses (such as office to supplement the data we normally in recent years. rent and wages of personnel, but collect in determining the PE In the CY 2012 PFS final rule with excluding malpractice expenses) component. On May 3, 2000, we comment period (76 FR 73057), we comprising PEs. The PE RVUs continue published the interim final rule (65 FR finalized a proposal to consolidate to represent the portion of these 25664) that set forth the criteria for the reviews of work and PE RVUs under resources involved in furnishing PFS submission of these supplemental PE section 1848(c)(2)(B) of the Act and services. survey data. The criteria were modified reviews of potentially misvalued codes Originally, the resource-based method in response to comments received, and under section 1848(c)(2)(K) of the Act was to be used beginning in 1998, but published in the Federal Register (65 into one annual process. section 4505(a) of the Balanced Budget FR 65376) as part of a November 1, 2000 In addition to the five-year reviews, Act of 1997 (Pub. L. 105–33, enacted on final rule. The PFS final rules published beginning for CY 2009, CMS and the August 5, 1997) (BBA) delayed in 2001 and 2003, respectively, (66 FR RUC have identified and reviewed a implementation of the resource-based 55246 and 68 FR 63196) extended the number of potentially misvalued codes PE RVU system until January 1, 1999. In period during which we would accept on an annual basis based on various addition, section 4505(b) of the BBA these supplemental data through March identification screens. This annual provided for a 4-year transition period 1, 2005. review of work and PE RVUs for from the charge-based PE RVUs to the In the CY 2007 PFS final rule with potentially misvalued codes was resource-based PE RVUs. comment period (71 FR 69624), we supplemented by the amendments to We established the resource-based PE revised the methodology for calculating section 1848 of the Act, as enacted by RVUs for each physicians’ service in a direct PE RVUs from the top-down to section 3134 of the Affordable Care Act, final rule, published on November 2, the bottom-up methodology beginning that require the agency to periodically

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identify, review and adjust values for 113–93, enacted on April 1, 2014) legislation was finalized in the CY 2016 potentially misvalued codes. (PAMA) added a new subparagraph (O) PFS final rule with comment period and to section 1848(c)(2) of the Act to e. Application of Budget Neutrality to revisions in this year’s rulemaking are establish an annual target for reductions Adjustments of RVUs discussed in section II.H. of this final in PFS expenditures resulting from rule. As described in section VI.C. of this adjustments to relative values of final rule, in accordance with section misvalued codes. If the estimated net II. Provisions of the Final Rule for PFS 1848(c)(2)(B)(ii)(II) of the Act, if reduction in expenditures for a year is revisions to the RVUs cause A. Determination of Practice Expense equal to or greater than the target for (PE) Relative Value Units (RVUs) expenditures for the year to change by that year, the provision specifies that more than $20 million, we make reduced expenditures attributable to 1. Overview adjustments to ensure that expenditures such adjustments shall be redistributed did not increase or decrease by more in a budget-neutral manner within the Practice expense (PE) is the portion of than $20 million. PFS. The provision specifies that the the resources used in furnishing a service that reflects the general 2. Calculation of Payments Based on amount by which such reduced categories of physician and practitioner RVUs expenditures exceed the target for a given year shall be treated as a expenses, such as office rent and To calculate the payment for each reduction in expenditures for the personnel wages, but excluding service, the components of the fee subsequent year for purposes of malpractice expenses, as specified in schedule (work, PE, and MP RVUs) are determining whether the target for the section 1848(c)(1)(B) of the Act. As adjusted by geographic practice cost subsequent year has been met. The required by section 1848(c)(2)(C)(ii) of indices (GPCIs) to reflect the variations provision also specifies that an amount the Act, we use a resource-based system in the costs of furnishing the services. equal to the difference between the for determining PE RVUs for each The GPCIs reflect the relative costs of target and the estimated net reduction in physicians’ service. We develop PE work, PE, and MP in an area compared expenditures, called the target recapture to the national average costs for each RVUs by considering the direct and amount, shall not be taken into account indirect practice resources involved in component. when applying the budget neutrality furnishing each service. Direct expense RVUs are converted to dollar amounts requirements specified in section categories include clinical labor, through the application of a CF, which 1848(c)(2)(B)(ii)(II) of the Act. The is calculated based on a statutory PAMA amendments originally made the medical supplies, and medical formula by CMS’s Office of the Actuary target provisions applicable for CYs equipment. Indirect expenses include (OACT). The formula for calculating the 2017 through 2020 and set the target for administrative labor, office expense, and Medicare fee schedule payment amount reduced expenditures at 0.5 percent of all other expenses. The sections that for a given service and fee schedule area estimated expenditures under the PFS follow provide more detailed can be expressed as: for each of those 4 years. information about the methodology for Payment = [(RVU work × GPCI work) + Subsequently, section 202 of the translating the resources involved in (RVU PE × GPCI PE) + (RVU MP × Achieving a Better Life Experience Act furnishing each service into service- GPCI MP)] × CF. of 2014 (Division B of Pub. L. 113–295, specific PE RVUs. We refer readers to enacted December 19, 2014) (ABLE) 3. Separate Fee Schedule Methodology the CY 2010 PFS final rule with accelerated the application of the target, for Anesthesia Services comment period (74 FR 61743 through amending section 1848(c)(2)(O) of the 61748) for a more detailed explanation Section 1848(b)(2)(B) of the Act Act to specify that target provisions of the PE methodology. specifies that the fee schedule amounts apply for CYs 2016, 2017, and 2018; and for anesthesia services are to be based setting a 1 percent target for reduced 2. Practice Expense Methodology on a uniform relative value guide, with expenditures for CY 2016 and a 0.5 a. Direct Practice Expense appropriate adjustment of an anesthesia percent target for CYs 2017 and 2018. conversion factor, in a manner to ensure The implementation of the target We determine the direct PE for a that fee schedule amounts for anesthesia legislation was finalized in the CY 2016 specific service by adding the costs of services are consistent with those for PFS final rule with comment period, the direct resources (that is, the clinical other services of comparable value. and revisions are discussed in section staff, medical supplies, and medical Therefore, there is a separate fee II.G. of this final rule. equipment) typically involved with schedule methodology for anesthesia Section 1848(c)(7) of the Act, as furnishing that service. The costs of the services. Specifically, we establish a added by section 220(e) of the PAMA, resources are calculated using the specified that for services that are not separate conversion factor for anesthesia refined direct PE inputs assigned to new or revised codes, if the total RVUs services and we utilize the uniform each CPT code in our PE database, for a service for a year would otherwise relative value guide, or base units, as which are generally based on our review well as time units, to calculate the fee be decreased by an estimated 20 percent of recommendations received from the schedule amounts for anesthesia or more as compared to the total RVUs RUC and those provided in response to services. Since anesthesia services are for the previous year, the applicable public comment periods. For a detailed not valued using RVUs, a separate adjustments in work, PE, and MP RVUs methodology for locality adjustments is shall be phased in over a 2-year period. explanation of the direct PE also necessary. This involves an Section 220(e) of the PAMA required methodology, including examples, we adjustment to the national anesthesia CF the phase-in of RVU reductions of 20 refer readers to the Five-Year Review of for each payment locality. percent or more to begin for 2017. Work Relative Value Units under the Section 1848(c)(7) of the Act was later PFS and Proposed Changes to the 4. Most Recent Changes to the Fee amended by section 202 of the ABLE Practice Expense Methodology proposed Schedule Act to require instead that the phase-in notice (71 FR 37242) and the CY 2007 Section 220(d) of the Protecting must begin in CY 2016. The PFS final rule with comment period (71 Access to Medicare Act of 2014 (Pub. L. implementation of the phase-in FR 69629).

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b. Indirect Practice Expense per Hour representing independent diagnostic Response: We have previously Data testing facilities (IDTFs), were blended identified several concerns regarding We use survey data on indirect PEs with supplementary survey data from the underlying data used in determining incurred per hour worked in developing the American College of Radiology PE RVUs in the CY 2014 PFS final rule the indirect portion of the PE RVUs. (ACR) and implemented for payments (78 FR 74246–74247). Even when we Prior to CY 2010, we primarily used the beginning in CY 2007. Neither IDTFs, first incorporated the survey data into practice expense per hour (PE/HR) by nor independent labs, participated in the PE methodology, many in the specialty that was obtained from the the PPIS. Therefore, we continue to use community expressed serious concerns AMA’s Socioeconomic Monitoring the PE/HR that was developed from over the accuracy of this or other PE Surveys (SMS). The AMA administered their supplemental survey data. surveys as a way of gathering data on PE Consistent with our past practice, the inputs from the diversity of providers a new survey in CY 2007 and CY 2008, previous indirect PE/HR values from the paid under the PFS. However, we the Physician Practice Expense supplemental surveys for these currently lack another source of Information Survey (PPIS). The PPIS is specialties were updated to CY 2006 comprehensive data regarding PE costs, a multispecialty, nationally using the Medicare Economic Index and as a result, we continue to believe representative, PE survey of both (MEI) to put them on a comparable basis that the PPIS survey data is the best data physicians and nonphysician with the PPIS data. currently available. We continue to seek practitioners (NPPs) paid under the PFS We also do not use the PPIS data for the best broad-based, auditable, using a survey instrument and methods reproductive endocrinology and spine routinely-updated source of information highly consistent with those used for surgery since these specialties currently regarding PE costs. the SMS and the supplemental surveys. are not separately recognized by The PPIS gathered information from Medicare, nor do we have a method to c. Allocation of PE to Services 3,656 respondents across 51 physician blend the PPIS data with Medicare- To establish PE RVUs for specific specialty and health care professional recognized specialty data. services, it is necessary to establish the groups. We believe the PPIS is the most Previously, we established PE/HR direct and indirect PE associated with comprehensive source of PE survey values for various specialties without each service. information available. We used the PPIS SMS or supplemental survey data by data to update the PE/HR data for the crosswalking them to other similar (1) Direct Costs CY 2010 PFS for almost all of the specialties to estimate a proxy PE/HR. The relative relationship between the Medicare-recognized specialties that For specialties that were part of the PPIS direct cost portions of the PE RVUs for participated in the survey. for which we previously used a any two services is determined by the When we began using the PPIS data crosswalked PE/HR, we instead used the relative relationship between the sum of in CY 2010, we did not change the PE PPIS-based PE/HR. We continue the direct cost resources (that is, the RVU methodology itself or the manner previous crosswalks for specialties that clinical staff, medical supplies, and in which the PE/HR data are used in did not participate in the PPIS. medical equipment) typically involved that methodology. We only updated the However, beginning in CY 2010, we with furnishing each of the services. PE/HR data based on the new survey. changed the PE/HR crosswalk for The costs of these resources are Furthermore, as we explained in the CY portable X-ray suppliers from radiology calculated from the refined direct PE 2010 PFS final rule with comment to IDTF, a more appropriate crosswalk inputs in our PE database. For example, period (74 FR 61751), because of the because these specialties are more if one service has a direct cost sum of magnitude of payment reductions for similar to each other for work time. $400 from our PE database and another some specialties resulting from the use For registered dietician services, the service has a direct cost sum of $200, of the PPIS data, we transitioned its use resource-based PE RVUs have been the direct portion of the PE RVUs of the over a 4-year period from the previous calculated in accordance with the final first service would be twice as much as PE RVUs to the PE RVUs developed policy that crosswalks the specialty to the direct portion of the PE RVUs for the using the new PPIS data. As provided in the ‘‘All Physicians’’ PE/HR data, as second service. the CY 2010 PFS final rule with adopted in the CY 2010 PFS final rule comment period (74 FR 61751), the with comment period (74 FR 61752) and (2) Indirect Costs transition to the PPIS data was complete discussed in more detail in the CY 2011 Section II.A.2.b. of this final rule for CY 2013. Therefore, PE RVUs from PFS final rule with comment period (75 describes the current data sources for CY 2013 forward are developed based FR 73183). We have incorporated the specialty-specific indirect costs used in entirely on the PPIS data, except as available utilization data for our PE calculations. We allocated the noted in this section. interventional cardiology, which indirect costs to the code level on the Section 1848(c)(2)(H)(i) of the Act became a recognized Medicare specialty basis of the direct costs specifically requires us to use the medical oncology during 2014. We finalized the use of a associated with a code and the greater supplemental survey data submitted in proxy PE/HR value for interventional of either the clinical labor costs or the 2003 for oncology drug administration cardiology in the CY 2016 final rule work RVUs. We also incorporated the services. Therefore, the PE/HR for with comment period (80 FR 70892), as survey data described earlier in the PE/ medical oncology, hematology, and there are no PPIS data for this specialty, HR discussion. The general approach to hematology/oncology reflects the by crosswalking the PE/HR from developing the indirect portion of the continued use of these supplemental Cardiology, since the specialties furnish PE RVUs is as follows: survey data. similar services in the Medicare claims • For a given service, we used the Supplemental survey data on data. direct portion of the PE RVUs calculated independent labs from the College of Comment: A commenter questioned as previously described and the average American Pathologists were the validity of the PPIS survey data percentage that direct costs represent of implemented for payments beginning in since it is nearly 10 years old. Several total costs (based on survey data) across CY 2005. Supplemental survey data other commenters stated that CMS’ the specialties that furnish the service to from the National Coalition of Quality estimated per-minute labor cost inputs determine an initial indirect allocator. Diagnostic Imaging Services (NCQDIS), are lower than actual labor costs. That is, the initial indirect allocator is

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calculated so that the direct costs equal For this reason, the facility PE RVUs are direct costs for all services from Step 1 the average percentage of direct costs of generally lower than the nonfacility PE and the utilization data for that service. those specialties furnishing the service. RVUs. Step 4: Using the results of Step 2 and For example, if the direct portion of the Step 3, use the conversion factor to (4) Services With Technical PE RVUs for a given service is 2.00 and calculate a direct PE scaling factor to Components (TCs) and Professional direct costs, on average, represented 25 ensure that the aggregate pool of direct percent of total costs for the specialties Components (PCs) PE costs calculated in Step 3 does not that furnished the service, the initial Diagnostic services are generally vary from the aggregate pool of direct PE indirect allocator would be calculated comprised of two components: A costs for the current year. Apply the so that it equals 75 percent of the total professional component (PC) and a scaling factor to the direct costs for each PE RVUs. Thus, in this example, the technical component (TC). The PC and service (as calculated in Step 1). initial indirect allocator would equal TC may be furnished independently or Step 5: Convert the results of Step 4 6.00, resulting in a total PE RVU of 8.00 by different providers, or they may be to an RVU scale for each service. To do (2.00 is 25 percent of 8.00 and 6.00 is furnished together as a ‘‘global’’ service. this, divide the results of Step 4 by the 75 percent of 8.00). When services have separately billable CF. Note that the actual value of the CF • Next, we added the greater of the PC and TC components, the payment for used in this calculation does not work RVUs or clinical labor portion of the global service equals the sum of the influence the final direct cost PE RVUs, the direct portion of the PE RVUs to this payment for the TC and PC. To achieve as long as the same CF is used in Step initial indirect allocator. In our this, we use a weighted average of the 4 and Step 5. Different CFs will result example, if this service had a work RVU ratio of indirect to direct costs across all in different direct PE scaling factors, but of 4.00 and the clinical labor portion of the specialties that furnish the global this has no effect on the final direct cost the direct PE RVU was 1.50, we would service, TCs, and PCs; that is, we apply PE RVUs since changes in the CFs and add 4.00 (since the 4.00 work RVUs are the same weighted average indirect changes in the associated direct scaling greater than the 1.50 clinical labor percentage factor to allocate indirect factors offset one another. portion) to the initial indirect allocator expenses to the global service, PCs, and (c) Create the Indirect Cost PE RVUs of 6.00 to get an indirect allocator of TCs for a service. (The direct PE RVUs 10.00. In the absence of any further use for the TC and PC sum to the global.) Create indirect allocators. of the survey data, the relative Step 6: Based on the survey data, relationship between the indirect cost (5) PE RVU Methodology calculate direct and indirect PE portions of the PE RVUs for any two For a more detailed description of the percentages for each physician services would be determined by the PE RVU methodology, we refer readers specialty. relative relationship between these to the CY 2010 PFS final rule with Step 7: Calculate direct and indirect indirect cost allocators. For example, if comment period (74 FR 61745 through PE percentages at the service level by one service had an indirect cost 61746). We also direct interested readers taking a weighted average of the results allocator of 10.00 and another service to the file called ‘‘Calculation of PE of Step 6 for the specialties that furnish had an indirect cost allocator of 5.00, RVUs under Methodology for Selected the service. Note that for services with the indirect portion of the PE RVUs of Codes’’ which is available on our Web TCs and PCs, the direct and indirect the first service would be twice as great site under downloads for the CY 2017 percentages for a given service do not as the indirect portion of the PE RVUs PFS final rule at http://www.cms.gov/ vary by the PC, TC, and global service. We use an average of the 3 most for the second service. Medicare/Medicare-Fee-for-Service- recent years of available Medicare • Next, we incorporated the specialty- Payment/PhysicianFeeSched/PFS- claims data to determine the specialty specific indirect PE/HR data into the Federal-Regulation-Notices.html. This mix assigned to each code. As we stated calculation. In our example, if, based on file contains a table that illustrates the in the CY 2016 final rule with comment the survey data, the average indirect calculation of PE RVUs as described period (80 FR 70894), we believe that cost of the specialties furnishing the below for individual codes. first service with an allocator of 10.00 the 3-year average will mitigate the need was half of the average indirect cost of (a) Setup File to use dominant or expected specialty the specialties furnishing the second First, we create a setup file for the PE instead of the claims data. Because we service with an indirect allocator of methodology. The setup file contains incorporated CY 2015 claims data for 5.00, the indirect portion of the PE the direct cost inputs, the utilization for use in the CY 2017 proposed rates, we RVUs of the first service would be equal each procedure code at the specialty believe that the finalized PE RVUs to that of the second service. and facility/nonfacility place of service associated with the CY 2017 PFS final rule provide a first opportunity to (3) Facility and Nonfacility Costs level, and the specialty-specific PE/HR data calculated from the surveys. determine whether service-level For procedures that can be furnished overrides of claims data are necessary. in a physician’s office, as well as in a (b) Calculate the Direct Cost PE RVUs Currently, in the development of PE facility setting, where Medicare makes a Sum the costs of each direct input. RVUs we apply only the overrides that separate payment to the facility for its Step 1: Sum the direct costs of the also apply to the MP RVU calculation. costs in furnishing a service, we inputs for each service. Since the proposed PE RVUs include a establish two PE RVUs: Facility, and Step 2: Calculate the aggregate pool of new year of claims into the 3-year nonfacility. The methodology for direct PE costs for the current year. We average for the first time, we solicited calculating PE RVUs is the same for set the aggregate pool of PE costs equal comment on the proposed CY 2017 PFS both the facility and nonfacility RVUs, to the product of the ratio of the current rates and whether or not the but is applied independently to yield aggregate PE RVUs to current aggregate incorporation of a new year of two separate PE RVUs. In calculating work RVUs and the proposed aggregate utilization data into a 3-year average the PE RVUs for services furnished in a work RVUs. mitigates the need for alternative facility, we do not include resources Step 3: Calculate the aggregate pool of service-level overrides such as a claims- that would generally not be provided by direct PE costs for use in ratesetting. based approach (dominant specialty) or physicians when furnishing the service. This is the product of the aggregate stakeholder-recommended approach

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(expected specialty) in the development (Note: For global services, the indirect specialty-specific indirect scaling factor of PE (and MP) RVUs for low-volume PE allocator is based on both the work by the average indirect scaling factor for codes. Prior year RVUs are available at RVUs and the clinical labor PE RVUs. the entire PFS. several locations on the PFS Web site We do this to recognize that, for the PC Step 16: Calculate the indirect located at http://www.cms.gov/ service, indirect PEs will be allocated practice cost index at the service level Medicare/Medicare-Fee-for-Service- using the work RVUs, and for the TC to ensure the capture of all indirect Payment/PhysicianFeeSched/. service, indirect PEs will be allocated costs. Calculate a weighted average of Comment: Several commenters using the direct PE RVUs and the the practice cost index values for the contended that even a multi-year clinical labor PE RVUs. This also allows specialties that furnish the service. average of claims data to determine the the global component RVUs to equal the (Note: For services with TCs and PCs, mix of specialties that furnish the sum of the PC and TC RVUs.) we calculate the indirect practice cost services creates distortions and wide For presentation purposes, in the index across the global service, PCs, and variability for low volume services, examples in the download file called TCs. Under this method, the indirect particularly those services with fewer ‘‘Calculation of PE RVUs under practice cost index for a given service than 100 annual Medicare claims. Methodology for Selected Codes’’, the (for example, echocardiogram) does not Commenters stated that low volume formulas were divided into two parts for vary by the PC, TC, and global service.) codes that use a specialty override each service. Step 17: Apply the service level appear to have stable PE and MP RVUs, • The first part does not vary by indirect practice cost index calculated while other low volume codes without service and is the indirect percentage in Step 16 to the service level adjusted overrides continue to shift from year to (direct PE RVUs/direct percentage). indirect allocators calculated in Step 11 year. Given these fluctuations, • The second part is either the work to get the indirect PE RVUs. commenters suggested that CMS RVU, clinical labor PE RVU, or both implement service-level overrides to depending on whether the service is a (d) Calculate the Final PE RVUs determine the specialty mix for these global service and whether the clinical Step 18: Add the direct PE RVUs from low volume procedures. These PE RVUs exceed the work RVUs (as Step 5 to the indirect PE RVUs from commenters provided a list of nearly described earlier in this step). Step 17 and apply the final PE budget 2000 codes and suggested specialty Apply a scaling adjustment to the neutrality (BN) adjustment. The final PE overrides. indirect allocators. BN adjustment is calculated by Response: We appreciate commenters’ Step 9: Calculate the current aggregate comparing the sum of steps 5 and 17 of interest in relatively stable PE and MP pool of indirect PE RVUs by multiplying to the proposed aggregate work RVUs RVUs and for continuing to highlight the result of step 8 by the average scaled by the ratio of current aggregate the challenges faced when determining indirect PE percentage from the survey PE and work RVUs. This adjustment the specialty allocation for low volume data. ensures that all PE RVUs in the PFS services. Since we did not make a Step 10: Calculate an aggregate pool of account for the fact that certain proposal regarding specialty overrides indirect PE RVUs for all PFS services by specialties are excluded from the for low volume services, we do not adding the product of the indirect PE calculation of PE RVUs but included in believe that it would be appropriate to allocators for a service from Step 8 and maintaining overall PFS budget establish overrides for several thousand the utilization data for that service. neutrality. (See ‘‘Specialties excluded codes at this time. However, given the Step 11: Using the results of Step 9 from ratesetting calculation’’ later in continued concerns, we will consider and Step 10, calculate an indirect PE this section.) the issue, including these specific adjustment so that the aggregate indirect recommendations, for future allocation does not exceed the available (e) Setup File Information rulemaking. aggregate indirect PE RVUs and apply it • Specialties excluded from Step 8: Calculate the service level to indirect allocators calculated in Step ratesetting calculation: For the purposes allocators for the indirect PEs based on 8. of calculating the PE RVUs, we exclude the percentages calculated in Step 7. Calculate the indirect practice cost certain specialties, such as certain NPPs The indirect PEs are allocated based on index. paid at a percentage of the PFS and low- the three components: The direct PE Step 12: Using the results of Step 11, volume specialties, from the calculation. RVUs; the clinical labor PE RVUs; and calculate aggregate pools of specialty- These specialties are included for the the work RVUs. specific adjusted indirect PE allocators purposes of calculating the BN For most services the indirect for all PFS services for a specialty by adjustment. They are displayed in Table allocator is: Indirect PE percentage * adding the product of the adjusted 1. (direct PE RVUs/direct percentage) + indirect PE allocator for each service work RVUs. and the utilization data for that service. TABLE 1—SPECIALTIES EXCLUDED There are two situations where this Step 13: Using the specialty-specific FROM RATESETTING CALCULATION formula is modified: indirect PE/HR data, calculate specialty- • If the service is a global service (that specific aggregate pools of indirect PE Specialty is, a service with global, professional, for all PFS services for that specialty by code Specialty description and technical components), then the adding the product of the indirect PE/ indirect PE allocator is: Indirect HR for the specialty, the work time for 49 ...... Ambulatory surgical center. percentage (direct PE RVUs/direct the service, and the specialty’s 50 ...... Nurse practitioner. percentage) + clinical labor PE RVUs + utilization for the service across all 51 ...... Medical supply company with certified orthotist. work RVUs. services furnished by the specialty. • If the clinical labor PE RVUs exceed 52 ...... Medical supply company with Step 14: Using the results of Step 12 certified prosthetist. the work RVUs (and the service is not and Step 13, calculate the specialty- 53 ...... Medical supply company with a global service), then the indirect specific indirect PE scaling factors. certified prosthetist-orthotist. allocator is: Indirect PE percentage Step 15: Using the results of Step 14, 54 ...... Medical supply company not in- (direct PE RVUs/direct percentage) + calculate an indirect practice cost index cluded in 51, 52, or 53. clinical labor PE RVUs. at the specialty level by dividing each 55 ...... Individual certified orthotist.

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TABLE 1—SPECIALTIES EXCLUDED TABLE 1—SPECIALTIES EXCLUDED only), is associated with the global FROM RATESETTING CALCULATION— FROM RATESETTING CALCULATION— service, CPT code 93000 Continued Continued (Electrocardiogram, routine ECG with at least 12 leads; with interpretation and Specialty Specialty description Specialty report). code code Specialty description • Payment modifiers: Payment 56 ...... Individual certified prosthetist. A7 ...... Department store. modifiers are accounted for in the 57 ...... Individual certified prosthetist- B2 ...... Pedorthic personnel. creation of the file consistent with orthotist. B3 ...... Medical supply company with current payment policy as implemented 58 ...... Medical supply company with pedorthic personnel. in claims processing. For example, registered pharmacist. services billed with the assistant at 59 ...... Ambulance service supplier, e.g., • Crosswalk certain low volume surgery modifier are paid 16 percent of private ambulance companies, physician specialties: Crosswalk the funeral homes, etc. the PFS amount for that service; 60 ...... Public health or welfare agen- utilization of certain specialties with therefore, the utilization file is modified cies. relatively low PFS utilization to the to only account for 16 percent of any 61 ...... Voluntary health or charitable associated specialties. • service that contains the assistant at agencies. Physical therapy utilization: surgery modifier. Similarly, for those 73 ...... Mass immunization roster biller. Crosswalk the utilization associated services to which volume adjustments 74 ...... Radiation therapy centers. with all physical therapy services to the are made to account for the payment 87 ...... All other suppliers (e.g., drug and specialty of physical therapy. department stores). modifiers, time adjustments are applied • Identify professional and technical 88 ...... Unknown supplier/provider spe- as well. For time adjustments to surgical services not identified under the usual cialty. services, the intraoperative portion in 89 ...... Certified clinical nurse specialist. TC and 26 modifiers: Flag the services 96 ...... Optician. that are PC and TC services but do not the work time file is used; where it is 97 ...... Physician assistant. use TC and 26 modifiers (for example, not present, the intraoperative A0 ...... Hospital. electrocardiograms). This flag associates percentage from the payment files used A1 ...... SNF. the PC and TC with the associated by contractors to process Medicare A2 ...... Intermediate care nursing facility. global code for use in creating the claims is used instead. Where neither is A3 ...... Nursing facility, other. available, we use the payment A4 ...... HHA. indirect PE RVUs. For example, the A5 ...... Pharmacy. professional service, CPT code 93010 adjustment ratio to adjust the time A6 ...... Medical supply company with (Electrocardiogram, routine ECG with at accordingly. Table 2 details the manner respiratory therapist. least 12 leads; interpretation and report in which the modifiers are applied.

TABLE 2—APPLICATION OF PAYMENT MODIFIERS TO UTILIZATION FILES

Modifier Description Volume adjustment Time adjustment

80, 81, 82 ...... Assistant at Surgery ...... 16% ...... Intraoperative portion. AS ...... Assistant at Surgery—Physician As- 14% (85% * 16%) ...... Intraoperative portion. sistant. 50 or LT and RT ... Bilateral Surgery ...... 150% ...... 150% of work time. 51 ...... Multiple Procedure ...... 50% ...... Intraoperative portion. 52 ...... Reduced Services ...... 50% ...... 50%. 53 ...... Discontinued Procedure ...... 50% ...... 50%. 54 ...... Intraoperative Care only...... Preoperative + Intraoperative Per- Preoperative + Intraoperative portion. centages on the payment files used by Medicare contractors to process Medicare claims. 55 ...... Postoperative Care only...... Postoperative Percentage on the Postoperative portion. payment files used by Medicare contractors to process Medicare claims. 62 ...... Co-surgeons ...... 62.5% ...... 50%. 66 ...... Team Surgeons ...... 33% ...... 33%.

We also make adjustments to volume MPPRs are not included in the with multiple beneficiaries and time that correspond to other development of the RVUs. concurrently, so that counting each payment rules, including special For anesthesia services, we do not service without regard to the overlap multiple procedure endoscopy rules and apply adjustments to volume since we with other services would overstate the multiple procedure payment reductions use the average allowed charge when amount of time spent by the practitioner (MPPRs). We note that section simulating RVUs; therefore, the RVUs as furnishing these services. 1848(c)(2)(B)(v) of the Act exempts calculated already reflect the payments • Work RVUs: The setup file contains certain reduced payments for multiple as adjusted by modifiers, and no volume the work RVUs from this final rule. imaging procedures and multiple adjustments are necessary. However, a therapy services from the BN time adjustment of 33 percent is made (6) Equipment Cost Per Minute calculation under section only for medical direction of two to four The equipment cost per minute is 1848(c)(2)(B)(ii)(II) of the Act. These cases since that is the only situation calculated as: where a single practitioner is involved

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(1/(minutes per year * usage)) * price * concur that the current rate likely Specifically, the RUC recommended ((interest rate/(1¥(1/((1 + interest understates the true cost of maintaining that we remove supply and equipment rate)∧ life of equipment)))) + some equipment. We also believe it items associated with film technology maintenance) likely overstates the maintenance costs from a previously specified list of codes Where: for other equipment. When we solicited since these items were no longer typical minutes per year = maximum minutes per comments regarding sources of data resource inputs. The RUC also year if usage were continuous (that is, containing equipment maintenance recommended that the Picture usage = 1); generally 150,000 minutes. rates, commenters were unable to Archiving and Communication System usage = variable, see discussion below. identify an auditable, robust data source (PACS) equipment be included for these price = price of the particular piece of that could be used by CMS on a wide imaging services since these items are equipment. scale. As a result, in the absence of typically used in furnishing imaging life of equipment = useful life of the publicly available datasets regarding services. However, since we did not particular piece of equipment. receive any invoices for the PACS maintenance = factor for maintenance; 0.05. equipment maintenance costs or another interest rate = variable, see discussion below. systematic data collection methodology system prior to that year’s proposed for determining maintenance factor, we rule, we were unable to determine the Usage: We currently use an do not believe that we have sufficient appropriate pricing to use for the inputs. equipment utilization rate assumption information at present to adopt a For CY 2015, we finalized our proposal of 50 percent for most equipment, with variable maintenance factor for to remove the film supply and the exception of expensive diagnostic equipment cost per minute pricing. We equipment items, and to create a new imaging equipment, for which we use a continue to investigate potential equipment item as a proxy for the PACS 90 percent assumption as required by avenues for determining equipment workstation as a direct expense (79 FR section 1848(b)(4)(C) of the Act. maintenance costs across a broad range 67561–67563). We used the price Stakeholders have often suggested of equipment items. associated with ED021 (computer, that particular equipment items are used Interest Rate: In the CY 2013 PFS final desktop, w-monitor) to price the new less frequently than 50 percent of the rule with comment period (77 FR item, ED050 (PACS Workstation Proxy), time in the typical setting and that CMS 68902), we updated the interest rates pending receipt of invoices to facilitate should reduce the equipment utilization used in developing an equipment cost pricing specific to the PACS rate based on these recommendations. per minute calculation. The interest rate workstation. Subsequent to establishing We appreciate and share stakeholders’ was based on the Small Business payment rates for CY 2015, we received interest in using the most accurate Administration (SBA) maximum information from several stakeholders assumption regarding the equipment interest rates for different categories of regarding pricing for items related to the utilization rate for particular equipment loan size (equipment cost) and maturity digital acquisition and storage of items. However, we believe that absent (useful life). The interest rates are listed images. We received invoices from one robust, objective, auditable data in Table 3. (See 77 FR 68902 for a stakeholder that facilitated a proposed regarding the use of particular items, the thorough discussion of this issue.) We price update for the PACS workstation 50 percent assumption is the most did not propose any changes to these in the CY 2016 PFS proposed rule, and appropriate within the relative value interest rates for CY 2017. we updated the price for the PACS system. We welcome the submission of workstation to $5,557 in the CY 2016 data that illustrates an alternative rate. TABLE 3—SBA MAXIMUM INTEREST PFS final rule with comment period (80 Maintenance: This factor for RATES FR 70899). maintenance was finalized in the CY In addition to the workstation used by 1998 PFS final rule (62 FR 33164). Interest rate the clinical staff for acquiring the We continue to investigate potential Price Useful life (%) images and furnishing the technical avenues for determining equipment component (TC) of the services, a maintenance costs across a broad range <$25K ...... <7 Years .... 7.50 stakeholder also submitted more of equipment items. $25K to $50K ... <7 Years .... 6.50 detailed information regarding a Comment: One commenter stated that >$50K ...... <7 Years .... 5.50 workstation used by the practitioner the cost of maintaining imaging <$25K ...... 7+ Years .... 8.00 interpreting the image in furnishing the equipment exceeds the cost of general $25K to $50K ... 7+ Years .... 7.00 professional component (PC) of many of >$50K ...... 7+ Years .... 6.00 medical equipment, and that for these services. imaging modalities the median As we stated in the CY 2015 PFS final maintenance cost is approximately 10 d. Changes to Direct PE Inputs for rule with comment period (79 FR percent of the equipment purchase Specific Services 67563), we generally believe that price. The commenter stated that the This section focuses on specific PE workstations used by these practitioners current 5 percent equipment inputs. The direct PE inputs are are more accurately considered indirect maintenance rate continues to be an included in the CY 2017 direct PE input costs associated with the PC of the inadequate and outdated reflection of database, which is available on our Web service. However, we understand that actual maintenance costs. The site under downloads for the CY 2017 the professional workstations for commenter also stated that information PFS final rule at http://www.cms.gov/ interpretation of digital images are on maintenance costs is readily Medicare/Medicare-Fee-for-Service- similar in principle to some of the available to CMS through both public Payment/PhysicianFeeSched/PFS- previous film inputs incorporated into and private sources. The commenter did Federal-Regulation-Notices.html. the global and technical components of not identify these sources. the codes, such as the view box Response: As we previously stated in (1) PE Inputs for Digital Imaging equipment. Given that the majority of the CY 2016 final rule with comment Services these services are reported globally in period (80 FR 70897), we agree with the Prior to the CY 2015 PFS rulemaking the nonfacility setting, we believe it is commenter that we do not believe the cycle, the RUC provided a appropriate to include these costs as annual maintenance factor for all recommendation regarding the PE direct inputs for the associated HCPCS equipment is exactly 5 percent, and we inputs for digital imaging services. codes. Based on our established

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methodology in which single codes with (78414–78499). We also did not propose incorporate the professional PACS professional and technical components to add the item to image guidance codes workstation, and the equipment minutes are constructed by assigning work RVUs where the dominant provider is not a to assign to the workstation. exclusively to the professional radiologist (77002, 77011, 77071, 77077, Comment: Commenters supported the component and direct PE inputs and 77081) according to the most recent general concept of the professional exclusively to the technical year of claims data, since we believe a PACS workstation and its addition to components, these costs would be single workstation would be more the proposed list of codes. Commenters incorporated into the PE RVUs of the typical in those cases. We identified stated that the professional PACS global and technical component of the approximately 426 codes to which we workstation is an essential component HCPCS code. proposed to add a professional PACS of diagnostic imaging procedures due to We stated in the CY 2016 PFS final workstation. Please see Table 4 for the the switch from film to digital rule with comment period that the costs full list of affected codes. technology, and the professional of the professional workstation may be For the professional PACS workstation would be an appropriate analogous to costs related to the use of workstation, we proposed to assign inclusion as a direct PE input for these film previously incorporated as direct equipment time equal to the intraservice services. PE inputs for these services. We also work time plus half of the preservice Response: We appreciate the support solicited comments on whether work time associated with the codes, from the commenters for the addition of including the professional workstation since the work time generally reflects the professional PACS workstation. as a direct PE input for these codes the time associated with the Comment: Many commenters would be appropriate, given that the professional interpretation. We addressed the subject of the proper resulting PE RVUs would be assigned to proposed half of the preservice work pricing of the professional PACS the global and technical components of time for the professional PACS workstation. Several commenters the codes. Commenters responded by workstation because we do not believe requested that CMS increase the price of indicating their approval of the concept that the practitioner would typically the workstation to include a third and of a professional PACS workstation used spend all of the preservice work period fourth monitor (for speech recognition) for interpretation of digital images. We using the equipment. For older codes priced at $1,715.98, an Admin Monitor received invoices for the pricing of a that do not have a breakdown of (the extra working monitor) priced at professional PACS workstation, as well physician work time by service period, $279.27, and a Powerscribe Microphone as additional invoices for the pricing of and only have an overall physician priced at $424.00. Commenters stated a mammography-specific version of the work time, we proposed to use half the that speech recognition equipment is professional PACS workstation. The total work time as an approximation of typical for a professional PACS RUC also included these new the intraservice work time plus one half workstation, and that physicians equipment items in its of the preservice work time. In our typically employed a monitor with recommendations for the CY 2017 PFS review of services that contained an rulemaking cycle. existing PACS workstation and had a greater resolution than what would be Based on our analysis of submitted breakdown of physician work time, we typically used for other purposes (such invoices, we proposed to price the found that half of the total time was a as for electronic health records). Related professional PACS workstation (ED053) reasonable approximation for the value comments contended that the proposed at $14,616.93. We did not propose a of intraservice work time plus one half pricing of the workstation remained change in price for the current technical of preservice work time where no such significantly less than what the average PACS workstation (ED050), which will breakdown existed. We also considered imaging facility spends on PACS remain at a price of $5,557.00. using an equipment time formula of the technology. Other commenters The price of the professional PACS physician intraservice time plus 1 disagreed with these sentiments and workstation is based upon individual minute (as a stand-in for the physician supported the pricing of the invoices submitted for the cost of a PC preservice work time). We solicited professional PACS workstation at the Tower ($1531.52), a pair of 3 MP public comment on the most accurate proposed rate of $14,616.93. monitors ($10,500.00 in total), a equipment time formula for the Response: We appreciate the feedback keyboard and mouse ($84.95), a UPS professional PACS workstation. from the commenters regarding the power backup devices for TNP We solicited public comment on the proper pricing of the professional PACS ($1098.00), and a switch for PACS proposed list of codes that would workstation. When proposing a price for monitors/workstations ($1402.46). incorporate the professional PACS the professional PACS workstation, we We proposed to add the professional workstation. We were interested in did not include the cost of the PACS workstation to many CPT codes public comment on the codes for which additional monitors and the in the 70000 series that use the current a professional PACS workstation should Powerscribe microphone because these technical PACS workstation (ED050) be included, and whether one of these items represent indirect costs under the and include professional work for professional workstations should be established PE methodology and the which such a workstation would be included for codes outside the 70000 functionality would unlikely have been used. We did not propose to add the series. In cases within the 70000 series included in the previously existing film equipment item to add-on codes since where radiologists are not the typical inputs the professional PACS the base codes would include minutes specialty reporting the code, such as workstation is replacing. Generally, we for the item. We also did not propose to CPT codes 77002 and 77011, we asked believe that monitors used to access add the item to codes that are whether it would be appropriate to add electronic health records and therapeutic in nature, as the one of the professional PACS microphones used for dictation are often professional PACS workstation is workstations to these services. used by practitioners who furnish a intended for use in diagnostic services. The following is a summary of the range a PFS services, are not allocable We therefore did not propose to add the comments we received on the proposed to particular services or patients, and item to codes in the Radiation Therapy addition of the professional PACS therefore, are included in the section (77261 through 77799) or the workstation, the pricing of the administrative cost category of practice Nuclear Medicine Cardiology section workstation, the list of codes that would expense, and therefore, are allocated to

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individual codes through indirect PE cases, the use of the professional PACS even when the physician is engaged in RVUs. workstation has been established to be these parallel work activities, the Comment: Many commenters stated typical for the code in question by the professional workstation is ‘‘open’’ to that CMS should expand the list of specialties furnishing the service, as a the patient at hand and cannot be used codes with a professional PACS result of the evidence provided in the for other patients. Commenters also workstation. Commenters generally comments submitted in response to our disagreed with the proposal to use half focused on three of the criteria proposed proposal. We have added the the total time for older codes in which by CMS: The exclusion of the workstation to many of the therapeutic there is no separation of preservice and workstation from add-on services, the codes requested by commenters, intraservice period times. Commenters exclusion of therapeutic (as opposed to specifically codes listed outside the stated that using the entire physician diagnostic) services, and the exclusion 70000 series, where use of the work time would be the best option of codes outside the 70000 series. professional PACS station is typical. since there is no accurate way to Commenters stated that add-on codes • Within the 70000 series, we estimate the service period times, and should be incorporated into the reviewed each of the codes submitted by that it would avoid potential confusion professional PACS workstation list, as commenters. Most of these codes did in equipment formulas in the future. they require additional time to perform, not fall within one of the categories Response: We continue to believe that and therefore, more time with the where we proposed to add the the professional PACS workstation is technical PACS workstation for the professional PACS workstation in the more accurately assigned equipment technician, as well as additional time proposed rule: They lacked a technical time by using half of the preservice for the review and interpretation PACS workstation, they were add-on physician work time rather than the full performed by the physician using the codes, or they were diagnostic preservice physician work time. As we professional PACS workstation. procedures for which radiology is not stated in the proposed rule, we do not Commenters also indicated that many the dominant specialty providing the believe that the practitioner would therapeutic services would also require service. We continue to believe that the typically spend all of the preservice a professional PACS workstation, and professional PACS workstation should work period using the equipment. disagreed with limiting the workstation not be added to codes that do not fall Commenters agreed that the physician to diagnostic services only. Finally, into these categories, since we believe may not need the professional commenters supplied extensive lists of that the image must be captured in order workstation for the full preservice additional codes, both inside and to for it to be interpreted, that the use period, but contended that the outside of the 70000 series, where they of the PACS workstation in the base equipment would be ‘‘open’’ and stated that the inclusion of a code reported with add-on codes would unavailable for use by other physicians professional PACS workstation was accurately capture the associated or for other patients. We disagree with warranted. resources used, and that the PACS this argument on clinical practice and Response: We appreciate the feedback professional workstation is only methodological grounds. We do not from the commenters in helping to typically used by radiologists. Based on agree that the professional PACS define the criteria for inclusion of the comments, we are adding the workstation would necessarily be professional PACS workstation, along professional workstation to only one unavailable for use by other physicians with more specific recommendations code in the 70000 series, CPT code when the physician in question is not about which codes should include the 73562, as it includes a technical PACS using the machine, Additionally, we workstation. After considering these workstation, is not an add-on code, and note that the number of minutes comments, we will be adding the is typically furnished by radiologists. assigned to the predecessor film inputs professional PACS workstation to • For codes in the 80000 and 90000 did not generally include the full additional suggested codes. We took the series, we are concerned about whether number of pre-service minutes. Finally, following into account in making these it is appropriate to include the technical our PE methodology is based on the additions: PACS workstation into many of these resources typically used to furnish the • We did not add the professional services. PACS workstations were procedure, and we typically assign time PACS workstation to any code that created for imaging purposes, but many for equipment items based on when it currently lacks a technical PACS of these services that include a technical cannot be used by another practitioner workstation (ED050) or lacks a work PACS workstation do not appear to or for another patient due to its use in RVU. We continue to believe that make use of imaging. Although we are the given procedure. We continue to procedures which do not include a not removing the technical PACS believe that half of the preservice technical workstation, or do not have workstation from these codes at this physician work time (along with the full physician work, would not require a time, we do not believe that a physician intraservice work time) is a professional workstation. professional PACS workstation should good approximation of the time in the • We did not add the professional be added to these procedures. We will preservice period that the professional PACS workstation to add-on codes. consider the inclusion of both PACS PACS workstation will typically be in Because the base codes include workstations for future rulemaking. use. As we stated in the proposed rule, equipment minutes for the workstation, Comment: Several commenters we do not believe that the practitioner we continue to believe it would be addressed the topic of equipment time would typically spend all of the duplicative to add additional equipment for the professional PACS workstation. preservice time using the equipment, time for the professional PACS Commenters requested that CMS and would also spend preservice time workstation in the add-on code. allocate the entire preservice physician on other activities, such as scrubbing • We agree with commenters that work time associated with the codes, as and dressing, for example. because the clinical utility of the PACS opposed to the proposed half of the For older codes where there is no workstation is not necessarily limited to preservice physician work time. breakdown of work time values by diagnostic services, there may be Commenters stated that although certain service period, we do not agree with therapeutic codes where it would be physician work activities in the commenters that the professional PACS reasonable to assume its use to be preservice period may not directly workstation should use the total work typical. We believe that in these specific involve the professional workstation, time. The comments do not provide a

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persuasive rationale for using the total physician work time. For therapeutic TABLE 4—CODES WITH PROFESSIONAL work time instead of our proposed codes, we are assigning equipment PACS WORKSTATION IN THE DIRECT alternative, developed for consistency minutes equal to half the preservice PE INPUT DATABASE—Continued with codes for which we do have work physician work time and half the time breakdowns by service period. postservice physician work time for the ED053 Therefore, in the absence of service second group. There are no therapeutic HCPCS Procedure type Minutes period work time detail, we continue to codes on our current list which lack a believe that half of the total work time service period time breakdown. The 47536 ...... Therapeutic ..... 16 is a reasonable proxy for the small following table lists all of the codes that 47537 ...... Therapeutic ..... 19 47538 ...... Therapeutic ..... 22 number of old codes affected by this include a professional PACS 47539 ...... Therapeutic ..... 26 issue. We are not concerned about the workstation for CY 2017, along with the 47540 ...... Therapeutic ..... 26 potential for confusion in the future equipment minutes for the workstation. 47541 ...... Therapeutic ..... 26 with differing equipment time formulas, 49083 ...... Therapeutic ..... 18 as the addition of the professional PACS TABLE 4—CODES WITH PROFESSIONAL 49405 ...... Therapeutic ..... 28 workstation to these codes is a one-time PACS WORKSTATION IN THE DIRECT 49406 ...... Therapeutic ..... 28 49407 ...... Therapeutic ..... 28 inclusion that will not affect the future PE INPUT DATABASE review of this equipment. 49418 ...... Therapeutic ..... 27 Finally, we believe that there is a 49440 ...... Therapeutic ..... 29 HCPCS Procedure type ED053 49441 ...... Therapeutic ..... 29 difference in the pattern of equipment Minutes 49442 ...... Therapeutic ..... 29 usage for the professional PACS 49446 ...... Therapeutic ..... 22 workstation between diagnostic and 10030 ...... Therapeutic ..... 23 49450 ...... Therapeutic ..... 20 therapeutic codes. Generally, the 10035 ...... Therapeutic ..... 15 49451 ...... Therapeutic ..... 20 intraservice work for diagnostic imaging 19081 ...... Therapeutic ..... 19 49452 ...... Therapeutic ..... 20 19083 ...... Therapeutic ..... 17 49460 ...... Therapeutic ..... 20 codes describes the review of images, 19085 ...... Therapeutic ..... 19 while the intraservice work for 49465 ...... Therapeutic ..... 13 19281 ...... Therapeutic ..... 18 50382 ...... Therapeutic ..... 28 therapeutic services describes a broader 19283 ...... Therapeutic ..... 19 range of activities. Therefore, although 50384 ...... Therapeutic ..... 24 19285 ...... Therapeutic ..... 18 50385 ...... Therapeutic ..... 27 we used an equipment formula of half 19287 ...... Therapeutic ..... 19 50386 ...... Therapeutic ..... 25 the preservice physician work time and 22510 ...... Therapeutic ..... 32 50387 ...... Therapeutic ..... 22 the full intraservice physician work 22511 ...... Therapeutic ..... 32 50389 ...... Therapeutic ..... 15 time for the diagnostic procedures, we 22513 ...... Therapeutic ..... 32 50430 ...... Therapeutic ..... 23 do not believe that this same time 22514 ...... Therapeutic ..... 32 50431 ...... Therapeutic ..... 20 32555 ...... Therapeutic ..... 19 50432 ...... Therapeutic ..... 25 formula would be appropriate for 32557 ...... Therapeutic ..... 19 therapeutic procedures since the 50433 ...... Therapeutic ..... 25 36221 ...... Therapeutic ..... 34 50434 ...... Therapeutic ..... 23 professional PACS workstation would 36222 ...... Therapeutic ..... 34 not be in use during the intraservice 50435 ...... Therapeutic ..... 18 36223 ...... Therapeutic ..... 34 50693 ...... Therapeutic ..... 25 portion of these services. Therefore, we 36224 ...... Therapeutic ..... 34 50694 ...... Therapeutic ..... 25 will use an equipment time formula of 36225 ...... Therapeutic ..... 34 50695 ...... Therapeutic ..... 25 half the preservice physician work time 36226 ...... Therapeutic ..... 34 58340 ...... Therapeutic ..... 7 and half the postservice physician work 36251 ...... Therapeutic ..... 31 62302 ...... Therapeutic ..... 17 time for the therapeutic codes to which 36252 ...... Therapeutic ..... 31 62303 ...... Therapeutic ..... 17 we are adding a professional PACS 36253 ...... Therapeutic ..... 31 62304 ...... Therapeutic ..... 17 36254 ...... Therapeutic ..... 31 workstation, which we believe is more 62305 ...... Therapeutic ..... 18 36598 ...... Therapeutic ..... 13 70015 ...... Diagnostic ...... 12 consistent with the descriptions of work 37184 ...... Therapeutic ..... 30 for the codes in question. Consistent 70030 ...... Diagnostic ...... 3 37187 ...... Therapeutic ..... 25 70100 ...... Diagnostic ...... 3 with our ongoing efforts to improve 37188 ...... Therapeutic ..... 23 70110 ...... Diagnostic ...... 4 payment accuracy for these costs, we 37191 ...... Therapeutic ..... 22 70120 ...... Diagnostic ...... 3 seek recommendations from the RUC 37192 ...... Therapeutic ..... 23 70130 ...... Diagnostic ...... 4 and other stakeholders on a more 37193 ...... Therapeutic ..... 23 70134 ...... Diagnostic ...... 4 precise allocation methodology for 37197 ...... Therapeutic ..... 26 70140 ...... Diagnostic ...... 3 equipment minutes for these 37220 ...... Therapeutic ..... 34 70150 ...... Diagnostic ...... 4 procedures. 37221 ...... Therapeutic ..... 34 70160 ...... Diagnostic ...... 3 After consideration of comments 37224 ...... Therapeutic ..... 34 70190 ...... Diagnostic ...... 3 37225 ...... Therapeutic ..... 34 70200 ...... Diagnostic ...... 4 received, we are finalizing our proposal 37226 ...... Therapeutic ..... 34 to add a professional PACS workstation 70210 ...... Diagnostic ...... 3 37227 ...... Therapeutic ..... 34 70220 ...... Diagnostic ...... 4 (ED053) to the equipment database and 37228 ...... Therapeutic ..... 34 70240 ...... Diagnostic ...... 3 price it at the proposed rate of 37229 ...... Therapeutic ..... 34 70250 ...... Diagnostic ...... 4 $14,616.93. We are dividing the codes 37230 ...... Therapeutic ..... 34 70260 ...... Diagnostic ...... 7 that will contain a professional PACS 37231 ...... Therapeutic ..... 34 70300 ...... Diagnostic ...... 2 workstation into diagnostic and 37236 ...... Therapeutic ..... 31 70310 ...... Diagnostic ...... 3 therapeutic categories. For diagnostic 37238 ...... Therapeutic ..... 31 70320 ...... Diagnostic ...... 3 codes, we are assigning equipment 37241 ...... Therapeutic ..... 26 70328 ...... Diagnostic ...... 3 minutes equal to half the preservice 37242 ...... Therapeutic ..... 31 70330 ...... Diagnostic ...... 22 37243 ...... Therapeutic ..... 38 physician work time and the full 70332 ...... Diagnostic ...... 6 37244 ...... Therapeutic ..... 38 70336 ...... Diagnostic ...... 20 intraservice physician work time. For 47531 ...... Therapeutic ..... 20 70350 ...... Diagnostic ...... 3 the relatively smaller group of 47532 ...... Therapeutic ..... 22 70355 ...... Diagnostic ...... 5 diagnostic codes with no service period 47533 ...... Therapeutic ..... 26 70360 ...... Diagnostic ...... 3 time breakdown, we are assigning 47534 ...... Therapeutic ..... 26 70370 ...... Diagnostic ...... 4 equipment time equal to half of the total 47535 ...... Therapeutic ..... 19 70371 ...... Diagnostic ...... 9

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TABLE 4—CODES WITH PROFESSIONAL TABLE 4—CODES WITH PROFESSIONAL TABLE 4—CODES WITH PROFESSIONAL PACS WORKSTATION IN THE DIRECT PACS WORKSTATION IN THE DIRECT PACS WORKSTATION IN THE DIRECT PE INPUT DATABASE—Continued PE INPUT DATABASE—Continued PE INPUT DATABASE—Continued

ED053 ED053 ED053 HCPCS Procedure type Minutes HCPCS Procedure type Minutes HCPCS Procedure type Minutes

70380 ...... Diagnostic ...... 3 72131 ...... Diagnostic ...... 18 73551 ...... Diagnostic ...... 4 70390 ...... Diagnostic ...... 5 72132 ...... Diagnostic ...... 12 73552 ...... Diagnostic ...... 5 70450 ...... Diagnostic ...... 12 72133 ...... Diagnostic ...... 12 73560 ...... Diagnostic ...... 4 70460 ...... Diagnostic ...... 15 72141 ...... Diagnostic ...... 23 73562 ...... Diagnostic ...... 5 70470 ...... Diagnostic ...... 18 72142 ...... Diagnostic ...... 26 73564 ...... Diagnostic ...... 6 70480 ...... Diagnostic ...... 13 72146 ...... Diagnostic ...... 23 73565 ...... Diagnostic ...... 4 70481 ...... Diagnostic ...... 13 72147 ...... Diagnostic ...... 26 73580 ...... Diagnostic ...... 6 70482 ...... Diagnostic ...... 14 72148 ...... Diagnostic ...... 23 73590 ...... Diagnostic ...... 4 70490 ...... Diagnostic ...... 13 72149 ...... Diagnostic ...... 26 73592 ...... Diagnostic ...... 3 70491 ...... Diagnostic ...... 13 72156 ...... Diagnostic ...... 28 73600 ...... Diagnostic ...... 4 70492 ...... Diagnostic ...... 14 72157 ...... Diagnostic ...... 28 73610 ...... Diagnostic ...... 4 70540 ...... Diagnostic ...... 14 72158 ...... Diagnostic ...... 28 73615 ...... Diagnostic ...... 6 70542 ...... Diagnostic ...... 19 72159 ...... Diagnostic ...... 31 73620 ...... Diagnostic ...... 4 70543 ...... Diagnostic ...... 19 72170 ...... Diagnostic ...... 5 73630 ...... Diagnostic ...... 4 70544 ...... Diagnostic ...... 13 72190 ...... Diagnostic ...... 3 73650 ...... Diagnostic ...... 3 70545 ...... Diagnostic ...... 18 72191 ...... Diagnostic ...... 28 73660 ...... Diagnostic ...... 3 70546 ...... Diagnostic ...... 18 72192 ...... Diagnostic ...... 12 73700 ...... Diagnostic ...... 18 70547 ...... Diagnostic ...... 13 72193 ...... Diagnostic ...... 12 73701 ...... Diagnostic ...... 11 70548 ...... Diagnostic ...... 20 72194 ...... Diagnostic ...... 12 73702 ...... Diagnostic ...... 12 70549 ...... Diagnostic ...... 25 72195 ...... Diagnostic ...... 30 73706 ...... Diagnostic ...... 35 70551 ...... Diagnostic ...... 21 72196 ...... Diagnostic ...... 26 73718 ...... Diagnostic ...... 20 70552 ...... Diagnostic ...... 23 72197 ...... Diagnostic ...... 30 73719 ...... Diagnostic ...... 25 70553 ...... Diagnostic ...... 28 72198 ...... Diagnostic ...... 28 73720 ...... Diagnostic ...... 30 70554 ...... Diagnostic ...... 43 72200 ...... Diagnostic ...... 3 73721 ...... Diagnostic ...... 23 71010 ...... Diagnostic ...... 4 72202 ...... Diagnostic ...... 3 73722 ...... Diagnostic ...... 24 71015 ...... Diagnostic ...... 3 72220 ...... Diagnostic ...... 3 73723 ...... Diagnostic ...... 32 71020 ...... Diagnostic ...... 4 72240 ...... Diagnostic ...... 19 73725 ...... Diagnostic ...... 33 71021 ...... Diagnostic ...... 4 72255 ...... Diagnostic ...... 18 74000 ...... Diagnostic ...... 4 71022 ...... Diagnostic ...... 4 72265 ...... Diagnostic ...... 18 74010 ...... Diagnostic ...... 3 71023 ...... Diagnostic ...... 5 72270 ...... Diagnostic ...... 23 74020 ...... Diagnostic ...... 4 71030 ...... Diagnostic ...... 4 72275 ...... Diagnostic ...... 36 74022 ...... Diagnostic ...... 4 71034 ...... Diagnostic ...... 5 72285 ...... Diagnostic ...... 9 74150 ...... Diagnostic ...... 14 71035 ...... Diagnostic ...... 3 72295 ...... Diagnostic ...... 9 74160 ...... Diagnostic ...... 17 71100 ...... Diagnostic ...... 5 73000 ...... Diagnostic ...... 3 74170 ...... Diagnostic ...... 21 71101 ...... Diagnostic ...... 4 73010 ...... Diagnostic ...... 3 74174 ...... Diagnostic ...... 33 71110 ...... Diagnostic ...... 4 73020 ...... Diagnostic ...... 3 74175 ...... Diagnostic ...... 28 71111 ...... Diagnostic ...... 5 73030 ...... Diagnostic ...... 5 74176 ...... Diagnostic ...... 25 71120 ...... Diagnostic ...... 3 73040 ...... Diagnostic ...... 6 74177 ...... Diagnostic ...... 28 71130 ...... Diagnostic ...... 3 73050 ...... Diagnostic ...... 3 74178 ...... Diagnostic ...... 33 71250 ...... Diagnostic ...... 18 73060 ...... Diagnostic ...... 4 74181 ...... Diagnostic ...... 15 71260 ...... Diagnostic ...... 17 73070 ...... Diagnostic ...... 3 74182 ...... Diagnostic ...... 28 71270 ...... Diagnostic ...... 13 73080 ...... Diagnostic ...... 4 74183 ...... Diagnostic ...... 35 71275 ...... Diagnostic ...... 28 73085 ...... Diagnostic ...... 6 74185 ...... Diagnostic ...... 33 71550 ...... Diagnostic ...... 15 73090 ...... Diagnostic ...... 3 74210 ...... Diagnostic ...... 5 71551 ...... Diagnostic ...... 30 73092 ...... Diagnostic ...... 3 74220 ...... Diagnostic ...... 5 71552 ...... Diagnostic ...... 28 73100 ...... Diagnostic ...... 4 74230 ...... Diagnostic ...... 12 71555 ...... Diagnostic ...... 33 73110 ...... Diagnostic ...... 4 74240 ...... Diagnostic ...... 7 72020 ...... Diagnostic ...... 3 73115 ...... Diagnostic ...... 6 74241 ...... Diagnostic ...... 7 72040 ...... Diagnostic ...... 4 73120 ...... Diagnostic ...... 4 74245 ...... Diagnostic ...... 9 72050 ...... Diagnostic ...... 6 73130 ...... Diagnostic ...... 4 74246 ...... Diagnostic ...... 7 72052 ...... Diagnostic ...... 6 73140 ...... Diagnostic ...... 3 74247 ...... Diagnostic ...... 18 72070 ...... Diagnostic ...... 4 73200 ...... Diagnostic ...... 18 74249 ...... Diagnostic ...... 9 72072 ...... Diagnostic ...... 3 73201 ...... Diagnostic ...... 11 74250 ...... Diagnostic ...... 5 72074 ...... Diagnostic ...... 3 73202 ...... Diagnostic ...... 12 74251 ...... Diagnostic ...... 33 72080 ...... Diagnostic ...... 3 73206 ...... Diagnostic ...... 35 74260 ...... Diagnostic ...... 6 72081 ...... Diagnostic ...... 6 73218 ...... Diagnostic ...... 25 74261 ...... Diagnostic ...... 43 72082 ...... Diagnostic ...... 7 73219 ...... Diagnostic ...... 25 74262 ...... Diagnostic ...... 48 72083 ...... Diagnostic ...... 8 73220 ...... Diagnostic ...... 30 74263 ...... Diagnostic ...... 42 72084 ...... Diagnostic ...... 9 73221 ...... Diagnostic ...... 23 74270 ...... Diagnostic ...... 7 72100 ...... Diagnostic ...... 4 73222 ...... Diagnostic ...... 23 74280 ...... Diagnostic ...... 23 72110 ...... Diagnostic ...... 6 73223 ...... Diagnostic ...... 35 74283 ...... Diagnostic ...... 19 72114 ...... Diagnostic ...... 6 73225 ...... Diagnostic ...... 31 74290 ...... Diagnostic ...... 4 72120 ...... Diagnostic ...... 4 73501 ...... Diagnostic ...... 4 74400 ...... Diagnostic ...... 18 72125 ...... Diagnostic ...... 18 73502 ...... Diagnostic ...... 5 74410 ...... Diagnostic ...... 6 72126 ...... Diagnostic ...... 12 73503 ...... Diagnostic ...... 6 74415 ...... Diagnostic ...... 6 72127 ...... Diagnostic ...... 12 73521 ...... Diagnostic ...... 5 74430 ...... Diagnostic ...... 4 72128 ...... Diagnostic ...... 18 73522 ...... Diagnostic ...... 6 74440 ...... Diagnostic ...... 5 72129 ...... Diagnostic ...... 12 73523 ...... Diagnostic ...... 7 74455 ...... Diagnostic ...... 4 72130 ...... Diagnostic ...... 12 73525 ...... Diagnostic ...... 6 74485 ...... Diagnostic ...... 6

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HCPCS Procedure type ED053 HCPCS Procedure type ED053 ED053 Minutes Minutes HCPCS Procedure type Minutes

74710 ...... Diagnostic ...... 4 76705 ...... Diagnostic ...... 11 78227 ...... Diagnostic ...... 18 74712 ...... Diagnostic ...... 68 76706 ...... Diagnostic ...... 13 78230 ...... Diagnostic ...... 19 74740 ...... Diagnostic ...... 5 76770 ...... Diagnostic ...... 13 78231 ...... Diagnostic ...... 23 75557 ...... Diagnostic ...... 45 76775 ...... Diagnostic ...... 11 78232 ...... Diagnostic ...... 28 75559 ...... Diagnostic ...... 58 76776 ...... Diagnostic ...... 13 78258 ...... Diagnostic ...... 27 75561 ...... Diagnostic ...... 50 76800 ...... Diagnostic ...... 14 78261 ...... Diagnostic ...... 21 75563 ...... Diagnostic ...... 66 76801 ...... Diagnostic ...... 18 78262 ...... Diagnostic ...... 25 75571 ...... Diagnostic ...... 13 76805 ...... Diagnostic ...... 18 78264 ...... Diagnostic ...... 13 75572 ...... Diagnostic ...... 25 76811 ...... Diagnostic ...... 35 78265 ...... Diagnostic ...... 18 75573 ...... Diagnostic ...... 38 76813 ...... Diagnostic ...... 23 78266 ...... Diagnostic ...... 23 75574 ...... Diagnostic ...... 35 76815 ...... Diagnostic ...... 8 78278 ...... Diagnostic ...... 18 75600 ...... Diagnostic ...... 6 76816 ...... Diagnostic ...... 18 78290 ...... Diagnostic ...... 18 75605 ...... Diagnostic ...... 11 76817 ...... Diagnostic ...... 13 78291 ...... Diagnostic ...... 31 75625 ...... Diagnostic ...... 11 76818 ...... Diagnostic ...... 35 78300 ...... Diagnostic ...... 15 75630 ...... Diagnostic ...... 13 76819 ...... Diagnostic ...... 28 78305 ...... Diagnostic ...... 22 75635 ...... Diagnostic ...... 50 76820 ...... Diagnostic ...... 13 78306 ...... Diagnostic ...... 11 75658 ...... Diagnostic ...... 13 76821 ...... Diagnostic ...... 13 78315 ...... Diagnostic ...... 11 75705 ...... Diagnostic ...... 20 76825 ...... Diagnostic ...... 45 78320 ...... Diagnostic ...... 24 75710 ...... Diagnostic ...... 11 76826 ...... Diagnostic ...... 11 78579 ...... Diagnostic ...... 8 75716 ...... Diagnostic ...... 13 76830 ...... Diagnostic ...... 13 78580 ...... Diagnostic ...... 13 75726 ...... Diagnostic ...... 11 76831 ...... Diagnostic ...... 30 78582 ...... Diagnostic ...... 15 75731 ...... Diagnostic ...... 11 76856 ...... Diagnostic ...... 13 78597 ...... Diagnostic ...... 13 75733 ...... Diagnostic ...... 13 76857 ...... Diagnostic ...... 10 78598 ...... Diagnostic ...... 13 75736 ...... Diagnostic ...... 11 76870 ...... Diagnostic ...... 10 78600 ...... Diagnostic ...... 16 75741 ...... Diagnostic ...... 13 76872 ...... Diagnostic ...... 20 78601 ...... Diagnostic ...... 18 75743 ...... Diagnostic ...... 16 76873 ...... Diagnostic ...... 40 78605 ...... Diagnostic ...... 21 75746 ...... Diagnostic ...... 11 76881 ...... Diagnostic ...... 18 78606 ...... Diagnostic ...... 22 75756 ...... Diagnostic ...... 11 76885 ...... Diagnostic ...... 20 78607 ...... Diagnostic ...... 29 75791 ...... Diagnostic ...... 33 76886 ...... Diagnostic ...... 15 78610 ...... Diagnostic ...... 10 75809 ...... Diagnostic ...... 5 76936 ...... Diagnostic ...... 71 78630 ...... Diagnostic ...... 24 75820 ...... Diagnostic ...... 7 76942 ...... Diagnostic ...... 19 78635 ...... Diagnostic ...... 36 75822 ...... Diagnostic ...... 11 76970 ...... Diagnostic ...... 8 78645 ...... Diagnostic ...... 32 75825 ...... Diagnostic ...... 11 77012 ...... Diagnostic ...... 11 78647 ...... Diagnostic ...... 15 75827 ...... Diagnostic ...... 11 77014 ...... Diagnostic ...... 9 78650 ...... Diagnostic ...... 40 75831 ...... Diagnostic ...... 11 77021 ...... Diagnostic ...... 53 78660 ...... Diagnostic ...... 16 75833 ...... Diagnostic ...... 14 77053 ...... Diagnostic ...... 5 78700 ...... Diagnostic ...... 17 75840 ...... Diagnostic ...... 11 77054 ...... Diagnostic ...... 5 78701 ...... Diagnostic ...... 18 75842 ...... Diagnostic ...... 14 77058 ...... Diagnostic ...... 50 78707 ...... Diagnostic ...... 22 75860 ...... Diagnostic ...... 11 77059 ...... Diagnostic ...... 55 78708 ...... Diagnostic ...... 32 75870 ...... Diagnostic ...... 11 77072 ...... Diagnostic ...... 3 78709 ...... Diagnostic ...... 40 75872 ...... Diagnostic ...... 11 77074 ...... Diagnostic ...... 5 78710 ...... Diagnostic ...... 21 75880 ...... Diagnostic ...... 7 77075 ...... Diagnostic ...... 6 78740 ...... Diagnostic ...... 30 75885 ...... Diagnostic ...... 14 77076 ...... Diagnostic ...... 12 78761 ...... Diagnostic ...... 20 75887 ...... Diagnostic ...... 14 77084 ...... Diagnostic ...... 15 78800 ...... Diagnostic ...... 28 75889 ...... Diagnostic ...... 11 78012 ...... Diagnostic ...... 8 78801 ...... Diagnostic ...... 32 75891 ...... Diagnostic ...... 11 78013 ...... Diagnostic ...... 13 78802 ...... Diagnostic ...... 24 75893 ...... Diagnostic ...... 6 78014 ...... Diagnostic ...... 13 78803 ...... Diagnostic ...... 43 75901 ...... Diagnostic ...... 11 78015 ...... Diagnostic ...... 31 78804 ...... Diagnostic ...... 35 75902 ...... Diagnostic ...... 13 78016 ...... Diagnostic ...... 49 78805 ...... Diagnostic ...... 25 75962 ...... Diagnostic ...... 6 78018 ...... Diagnostic ...... 29 78806 ...... Diagnostic ...... 23 75966 ...... Diagnostic ...... 13 78070 ...... Diagnostic ...... 13 78807 ...... Diagnostic ...... 37 75978 ...... Diagnostic ...... 6 78071 ...... Diagnostic ...... 18 79440 ...... Diagnostic ...... 24 75984 ...... Diagnostic ...... 8 78072 ...... Diagnostic ...... 23 G0106 ...... Diagnostic ...... 24 75989 ...... Diagnostic ...... 12 78075 ...... Diagnostic ...... 38 G0120 ...... Diagnostic ...... 24 76000 ...... Diagnostic ...... 3 78102 ...... Diagnostic ...... 18 G0297 ...... Diagnostic ...... 18 76010 ...... Diagnostic ...... 3 78103 ...... Diagnostic ...... 22 G0365 ...... Diagnostic ...... 20 76080 ...... Diagnostic ...... 6 78104 ...... Diagnostic ...... 20 G0389 ...... Diagnostic ...... 9 76098 ...... Diagnostic ...... 3 78135 ...... Diagnostic ...... 48 76100 ...... Diagnostic ...... 6 78140 ...... Diagnostic ...... 40 76101 ...... Diagnostic ...... 6 78185 ...... Diagnostic ...... 16 (2) Standardization of Clinical Labor 76102 ...... Diagnostic ...... 6 78190 ...... Diagnostic ...... 40 Tasks 76120 ...... Diagnostic ...... 5 78195 ...... Diagnostic ...... 30 As we noted in the CY 2015 PFS final 76376 ...... Diagnostic ...... 8 78201 ...... Diagnostic ...... 16 rule (79 FR 67640–67641), we continue 76380 ...... Diagnostic ...... 10 78202 ...... Diagnostic ...... 20 76390 ...... Diagnostic ...... 28 78205 ...... Diagnostic ...... 20 to make improvements to the direct PE 76506 ...... Diagnostic ...... 10 78206 ...... Diagnostic ...... 25 input database to provide the number of 76536 ...... Diagnostic ...... 12 78215 ...... Diagnostic ...... 13 clinical labor minutes assigned for each 76604 ...... Diagnostic ...... 9 78216 ...... Diagnostic ...... 22 task for every code in the database 76700 ...... Diagnostic ...... 14 78226 ...... Diagnostic ...... 13 instead of only including the number of

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clinical labor minutes for the preservice, updated simultaneously for all codes labor minutes that were assigned based service, and postservice periods for each with the applicable clinical labor tasks, on film technology. code. In addition to increasing the instead of waiting for individual codes As noted in the paragraphs above, we transparency of the information used to to be reviewed. continue to improve the direct PE input set PE RVUs, this improvement would In the following paragraphs, we database by specifying for each code the allow us to compare clinical labor times address a series of issues related to minutes associated with each clinical for activities associated with services clinical labor tasks, particularly relevant labor task. Once completed, this work across the PFS, which we believe is to services currently being reviewed would allow adjustments to be made to important to maintaining the relativity under the misvalued code initiative. minutes assigned to particular clinical of the direct PE inputs. This information labor tasks related to digital technology (a) Clinical Labor Tasks Associated With would facilitate the identification of the that occur in multiple codes, consistent Digital Imaging usual numbers of minutes for clinical with the changes that were made to labor tasks and the identification of In CY 2015 PFS rulemaking, we noted individual supply and equipment items. exceptions to the usual values. It would that the RUC recommendation regarding In the meantime, we believe it would be also allow for greater transparency and inputs for digital imaging services appropriate to establish standard times consistency in the assignment of indicated that, as each code is reviewed for clinical labor tasks associated with equipment minutes based on clinical under the misvalued code initiative, the all digital imaging services for purposes labor times. Finally, we believe that the clinical labor tasks associated with of reviewing individual services at information can be useful in digital technology (instead of film) present, and for possible broad-based maintaining standard times for would need to be addressed. When we standardization once the changes to the particular clinical labor tasks that can be reviewed that recommendation, we did direct PE input database facilitate our applied consistently to many codes as not have the capability of assigning ability to adjust time across services. they are valued over several years, standard clinical labor times for the During the CY 2016 PFS rulemaking similar in principle to the use of hundreds of individual codes since the cycle, we proposed appropriate physician preservice time packages. We direct PE input database did not standard minutes for five different believe such standards would provide previously allow for comprehensive clinical labor tasks associated with greater consistency among codes that adjustments for clinical labor times services that use digital imaging share the same clinical labor tasks and based on particular clinical labor tasks. technology. In the CY 2016 PFS final could improve relativity of values Therefore, consistent with the rule with comment period (80 FR among codes. For example, as medical recommendation, we proposed to 70901), we finalized appropriate practice and technologies change over remove film-based supply and standard minutes for four of those five time, changes in the standards could be equipment items but maintain clinical activities, which are listed in Table 5.

TABLE 5—CLINICAL LABOR TASKS ASSOCIATED WITH DIGITAL IMAGING TECHNOLOGY

Typical Clinical labor task minutes

Availability of prior images confirmed ...... 2 Patient clinical information and questionnaire reviewed by technologist, order from physician confirmed and exam protocoled by radiologist ...... 2 Review examination with interpreting MD ...... 2 Exam documents scanned into PACS. Exam completed in RIS system to generate billing process and to populate images into Radiologist work queue ...... 1

We did not finalize standard minutes activity should not have a standard time codes that share the same clinical labor for the activity ‘‘Technologist QC’s value. Commenters stated that the tasks and can improve relativity of images in PACS, checking for all number of minutes varies significantly values among codes. We proposed to images, reformats, and dose page.’’ We for different imaging modalities; and the establish a range of appropriate standard agreed with commenters that this task time is not simply based on the quantity minutes for the clinical labor activity, may require a variable length of time of images to be reviewed, but also the ‘‘Technologist QCs images in PACS, depending on the number of images to complexity of the images. The checking for all images, reformats, and be reviewed. We stated that it may be commenters recommended that time for dose page.’’ These standard minutes appropriate to establish several different this clinical labor activity should be will be applied to new and revised standard times for this clinical labor assigned on a code by code basis. We codes that make use of this clinical task for a low/medium/high quantity of agree with the commenters that the labor activity when they are reviewed images to be reviewed, in the same amount of clinical labor needed to by us for valuation. We proposed 2 fashion that the clinical labor assigned check images in a PACS workstation minutes as the standard for the simple to clean a surgical instrument package may vary depending on the service. case, 3 minutes as the standard for the has two different standard times However, we do not believe that this intermediate case, and 4 minutes as the depending on the use of a basic pack (10 precludes the possibility of establishing standard for the complex case. We minutes) or a medium pack (30 standards for clinical labor tasks as we proposed the simple case of 2 minutes minutes). We solicited public comment have done in the past by creating as the standard for the typical procedure and feedback on this subject, with the multiple standard times, for example, code involving routine use of imaging. anticipation of including a proposal in those assigned to cleaning different These values are based upon a review of the CY 2017 proposed rule. kinds of scopes. We continue to believe the existing minutes assigned for this We received many comments that the use of clinical labor standards clinical labor activity; we have suggesting that this clinical labor provides greater consistency among determined that 2 minutes is the

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duration for most services and a small Comment: One commenter requested and intermediate categories as number of codes with more complex a broad study of the actual clinical labor proposed. times associated with digital imaging. forms of digital imaging have higher (b) Pathology Clinical Labor Tasks values. We proposed to use 2 minutes Response: We appreciate the for services involving routine X-rays importance of incorporating robust, As with the clinical labor tasks (simple), 3 minutes for services auditable, and routinely updated data associated with digital imaging, many of involving CTs and MRIs (intermediate), sources for use in the determination of the currently assigned times for the and 4 minutes for the most highly RVUs. We welcome stakeholder specialized clinical labor tasks complex services, which would exceed information on the availability of such associated with pathology services are these more typical cases. We solicited data, while we continue to consider the not consistent across codes. In comments regarding the most accurate best means of acquiring such data. reviewing past RUC recommendations category—simple, intermediate, or Comment: Several commenters for pathology services, we have not complex for existing codes, and in addressed our specific proposal for the identified information that supports the particular what criteria might be used to clinical labor task, ‘‘Technologist QCs judgment that the same tasks take significantly more or less time identify complex cases systematically. images in PACS, checking for all images, reformats, and dose page.’’ depending on the individual service for The following is summary of the which they are performed, especially comments we received regarding the Commenters requested that, short of no standard times at all, the establishment given the high degree of specificity with ongoing standardization of clinical labor which the tasks are described. We of categories for this clinical labor task tasks, and our specific proposal continue to believe that, in general, a should be as follows: Simple (2 min); regarding the clinical labor task, clinical labor task will tend to take the intermediate (3 min), complex (4 min) ‘‘Technologist QCs images in PACS, same amount of time to perform for one and highly complex (5 min). checking for all images, reformats, and individual service as the same clinical dose page.’’ Response: We appreciate the labor task when it is performed in a suggestion from the commenters to Comment: Many commenters restated clinically similar service. adopt a categorization system very Therefore, we developed standard their opposition to the principle of similar to our proposal, with the establishing standard values for clinical times for clinical labor tasks that we addition of an extra category for highly have used in finalizing direct PE inputs labor tasks. Commenters contended that complex services valued at 5 minutes. clinical labor tasks were highly variable in recent years, starting in the CY 2012 We agree with this addition to our PFS final rule with comment period (76 across different specialties, that the proposal, as it will allow for additional standardization process would disrupt FR 73213). These times were based on specificity in classifying different types our review and assessment of the the relativity of direct PE inputs across of imaging services, including those that the PFS, and that the proposed standard current times included for these clinical are unusually complex. However, we labor tasks in the direct PE input times were too low and underestimated note that we proposed to define the database. We proposed in the CY 2016 the staffing time needed to carry out the simple case of 2 minutes as the standard PFS proposed rule to establish standard tasks in question. Commenters stressed for the typical procedure code involving times for a list of 17 clinical labor tasks that each code should be evaluated on routine use of imaging, and we believe related to pathology services, and an individual basis. One commenter only a small number of codes with more solicited public feedback regarding our expressed support for the overall complex forms of digital imaging would proposed standards. Many commenters concept regarding efforts to streamline typically involve more time for the task. stated in response to our proposal that the time for clinical labor activities. We proposed to use 2 minutes for they did not support the standardization Response: We note the objections services involving routine X-rays (the of clinical labor activities across raised by the commenters to the process simple case), and 3 minutes for services pathology services. Commenters stated of standardizing time values for clinical involving CTs and MRIs (the that establishing a single standard time labor tasks. However, as we have stated intermediate case). We seek for each clinical labor task was previously, we believe the recommendations from the RUC and infeasible due to the differences in batch establishment of standards can provide other stakeholders and we intend to size or number of blocks across different greater consistency among codes that request feedback from commenters pathology procedures. Several share the same clinical labor tasks, as through future rulemaking to assist in commenters indicated that it might be well as improve relativity of values identifying what we believe would be possible to standardize across codes among codes. We also note that we do the small number of services that fall with the same batch sizes, and urged us evaluate each code on an individual into the complex (4 min) and highly to consider pathology-specific details, basis for direct PE inputs, and complex (5 min) categories, and the such as batch size and block number, in establishing clinical labor standards specific basis used to set the two the creation of any future standard times assists in that process of individual categories apart from one another. In the for clinical labor tasks related to review. We continue to allow clinical meantime, we will consider individual pathology services. labor times above the standard values codes on a case by case basis for this As we stated in the CY 2016 PFS for individual services, provided that clinical labor task. proposed rule, we developed the there is a compelling rationale to After considering the comments proposed standard times based on our explain why that particular service received, we are finalizing a range of review and assessment of the current requires additional clinical labor time appropriate standard minutes for the times included for these clinical labor above and beyond the standard. We clinical labor activity, ‘‘Technologist tasks in the direct PE input database. believe that establishing a range of QCs images in PACS, checking for all We believe that, generally speaking, standard minutes for this particular images, reformats, and dose page’’ as clinical labor tasks with the same digital imaging clinical labor task will follows: Simple (2 min); intermediate (3 description are comparable across provide clarity and help maintain min), complex (4 min) and highly different pathology procedures. We relativity across a wide range of imaging complex (5 min). We are also finalizing believe this to be true based on the services. our criteria for determining the simple comparability of clinical labor tasks in

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non-pathology services, as well as the information regarding batch size and would typically remain standard across high degree of specificity with which number of blocks during review of different services without varying by most clinical labor tasks for pathology individual pathology services on an block number or batch size, with the services are described relative to clinical intermittent basis in the past. We understanding that additional time may labor tasks associated with other PFS requested regular submission of these be required above the standard value for services. We concurred with details on the PE worksheets supplied a clinical labor task that is part of an commenters that accurate clinical labor by the RUC as part of the review process unusually complex or difficult service. times for pathology codes may be for pathology services, as a means to As a result, we ultimately finalized dependent on the number of blocks or assist in the determination of the most standard times for 6 of the 17 proposed batch size typically used for each accurate direct PE inputs. clinical labor activities in the CY 2016 individual service. However, we also We also stated our belief that many of final rule with comment period (80 FR believe that it is appropriate and the clinical labor activities for which we feasible to establish ‘‘per block’’ proposed to establish standard times 70902). We have listed the finalized standards or standards varied by batch were tasks that do not depend on standard times in Table 6. We are taking size assumptions for many clinical labor number of blocks or batch size. Clinical no further action on the remaining 11 activities that would be comparable labor activities such as ‘‘Clean room/ clinical labor activities in this final rule, across a wide range of individual equipment following procedure’’ and pending further action by the RUC (see services. We have received detailed ‘‘Dispose of remaining specimens’’ below).

TABLE 6—STANDARD TIMES FOR CLINICAL LABOR TASKS ASSOCIATED WITH PATHOLOGY SERVICES

Standard clinical labor Clinical labor task time (minutes)

Accession specimen/prepare for examination ...... 4 Assemble and deliver slides with paperwork to pathologists ...... 0.5 Assemble other light microscopy slides, open nerve biopsy slides, and clinical history, and present to pathologist to prepare clinical pathologic interpretation ...... 0.5 Clean room/equipment following procedure (including any equipment maintenance that must be done after the procedure) ..... 1 Dispose of remaining specimens, spent chemicals/other consumables, and hazardous waste ...... 1 Prepare, pack and transport specimens and records for in-house storage and external storage (where applicable) ...... 1

We remain committed to the process inconsistencies involving the use of printer. We believe that these of establishing standard clinical labor scopes and the video systems associated equipment components represent the times for tasks associated with with them. Some of the scopes include typical case for a scope video system. pathology services. This may include video systems bundled into the Our model for this system is the ‘‘video establishing standards on a per-block or equipment item, some of them include system, endoscopy (processor, digital per-batch basis, as we indicated during scope accessories as part of their price, capture, monitor, printer, cart)’’ the previous rulemaking cycle. and some of them are standalone scopes equipment item (ES031), which we However, we are aware that the PE with no other equipment included. It is proposed to re-price as part of this Subcommittee of the RUC is currently not always clear which equipment items separate pricing approach. We obtained working to standardize the pathology related to scopes fall into which of these current pricing invoices for the clinical labor activities they use in categories. We have also frequently endoscopy video system as part of our making their recommendations. We found anomalies in the equipment investigation of these issues involving believe the RUC’s efforts to narrow the recommendations, with equipment scopes, which we proposed to use for current list of several hundred items that consist of a scope and video this re-pricing. We understand that pathology clinical labor tasks to a more system bundle recommended, along there may be other accessories manageable number through the with a separate scope video system. associated with the use of scopes; we consolidation of duplicative or highly Based on our review, the variations do proposed to separately price any scope similar activities into a single not appear to be consistent with the accessories, and individually evaluate description may serve PFS relativity and different code descriptions. their inclusion or exclusion as direct PE facilitate greater transparency in PFS To promote appropriate relativity inputs for particular codes as usual ratesetting. We also believe that the among the services and facilitate the under our current policy based on RUC’s standardization of pathology transparency of our review process, whether they are typically used in clinical labor tasks would facilitate our during review of recommended direct furnishing the services described by the capacity to establish standard times for PE inputs for the CY 2017 PFS proposed particular codes. pathology clinical labor tasks in future rule, we developed a structure that We also proposed standardizing rulemaking. Therefore, we did not separates the scope and the associated refinements to the way scopes have propose any additional changes to video system as distinct equipment been defined in the direct PE input clinical labor tasks associated with items for each code. Under this database. We believe that there are four pathology services. approach, we proposed standalone general types of scopes: Non-video prices for each scope, and separate scopes; flexible scopes; semi-rigid (3) Equipment Recommendations for prices for the video systems that are scopes, and rigid scopes. Flexible Scope Systems used with scopes. We would define the scopes, semi-rigid scopes, and rigid During our routine reviews of direct scope video system as including: (1) A scopes would typically be paired with PE input recommendations, we have monitor; (2) a processor; (3) a form of one of the video scope systems, while regularly found unexplained digital capture; (4) a cart; and (5) a the non-video scopes would not. The

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flexible scopes can be further divided Another commenter requested that CMS and requested that CMS incorporate into diagnostic (or non-channeled) and make no change for CY 2017 for any them into the pricing of the equipment. therapeutic (or channeled) scopes. We endoscopy procedures until proper Response: We appreciate the feedback proposed to identify for each anatomical identification of the capital and from the commenters about pricing, application: (1) A rigid scope; (2) a disposable cost inputs could be especially the submission of new data in semi-rigid scope; (3) a non-video confirmed. the form of additional invoices. We flexible scope; (4) a non-channeled Response: We appreciate commenters’ agree that the cost of a digital capture flexible video scope; and (5) a interests in making certain that there is device should be included in the cost of channeled flexible video scope. We appropriate opportunity for the endoscopy video system; it was our proposed to classify the existing scopes stakeholders to provide feedback and belief that the digital capture device was in our direct PE database under this recommendations on the reclassification included in the cost of the processor. classification system, to improve the of scopes and related scope equipment. We appreciate the clarification from the transparency of our review process and This was our primary rationale for commenters indicating that this is not improve appropriate relativity among limiting proposed changes regarding the case, and that the digital capture the services. We plan to propose input these kinds of inputs to codes reviewed device is a separately priced component prices for these equipment items for the current CY 2017 rule cycle, that of the video system. As a result, we are through future rulemaking. is, the Flexible Laryngoscope and averaging the price of the digital capture We proposed these changes only for Laryngoplasty families of codes. device on the two submitted invoices the reviewed codes that make use of Because these codes are under current and pricing it at $18,346.00. We will scopes; this applies to the codes in the review; however, we believe that they add this into the overall cost of the Flexible Laryngoscope family (CPT should be valued according to a scheme endoscopy video system. codes 31572, 31573, 31574, 31575, that accurately describes the scope For the other four components of the 31576, 31577, 31578, 31579) (see equipment typically used in the video system, we are finalizing the section II.L) and the Laryngoplasty services. As a result, we continue to prices as proposed. The invoices family (CPT codes 31551, 31552, 31553, believe that our proposed classification submitted for these components 31554, 31580, 31584, 31587, 31591, system for scopes is the more sound indicate that they are different forms of 31592) (see section II.L) along with methodology to use for valuation of equipment with different product IDs updated prices for the equipment items these two families of codes for CY 2017. and different prices. For example, our related to scopes utilized by these However, we note that we would expect price for the processor comes from a services. We also solicited comment on to include examination of these codes as ‘‘Video Processor with keyboard & video this separate pricing structure for part of any broader proposal we would cable’’ (CV–180) as opposed to the scopes, scope video systems, and scope make regarding scope equipment items, newly submitted invoice for a ‘‘Viscera accessories, which we could consider in response to new recommendations on Elite Video System’’ (OTV–S190). These proposing to apply to other codes in the subject. are two distinct equipment items, and future rulemaking. We look forward to receiving we do not have any data to indicate that The following is a summary of the recommendations from the upcoming the equipment on the newly submitted comments we received on this separate RUC PE Subcommittee regarding scopes invoices is more typical in its use than pricing structure for scopes, scope video and related scope equipment items. We the equipment that we are currently systems, and scope accessories. note that in order for these using to price the endoscopy video Comment: Many commenters recommendations to be considered for system. addressed our general proposal to CY 2018 rulemaking, we would need to Therefore, we are finalizing the price reclassify scopes and their related receive these recommendations by the of the endoscopy video system at equipment items. Commenters same February deadline for the $33,391.00, based on component prices expressed their support for the decision submission of recommendations on of $9,000.00 for the processor, to remove the scopes from the proposed code valuations. $18,346.00 for the digital capture scope packages, and the proposed Comment: Many commenters device, $2,000.00 for the monitor, definition of the scope video system disagreed with the CMS proposal to $2,295.00 for the printer, and $1,750.00 based on the current endoscopy video price the endoscopy video system for the cart. system equipment item (ES031). There (ES031) at a price of $15,045.00. Some Comment: A few commenters also were no comments opposing the general commenters stated that CMS should use addressed the pricing of related scope principle behind reclassifying scopes the submitted invoices for the pricing of accessories. They stated that the and scope equipment. this equipment, which recommended a proposed price for the fiberscope, Response: We appreciate the support price of $49,400.00. One commenter flexible, rhinolaryngoscopy (ES020) was from the commenters for the broad stated that the proposed amount did not decreased by 33 percent based on one project to clarify these issues related to accurately reflect the current price of GI unrepresentative invoice and that this scopes. endoscopy video systems. Another price undervalued the actual cost. Comment: Many commenters also commenter stated that CMS had defined Similarly, commenters stated that the requested that CMS delay implementing the endoscopy video system as proposed price for the stroboscopy the scope proposal until additional time containing five items: (1) A monitor; (2) system (ES065) at $19,100 was much could be devoted to the subject. Several a processor; (3) a form of digital capture; lower than the manufacturer average commenters asked CMS to wait to make (4) a cart; and (5) a printer. However, the invoice pricing. The proposed prices for any changes until the RUC could form commenter pointed out that CMS had the channeled and non-channeled a PE Subcommittee to address this not included a price for the digital flexible video rhinolaryngoscopes issue. For codes with proposed CY 2017 capture device, which the commenter (ES064 and ES063 respectively) were values, commenters urged CMS to adopt stressed was a significant part of the also both two to three times lower than the RUC-recommended direct PE inputs overall cost and needed to be included the manufacturer’s average invoice instead of the proposed direct PE in the equipment’s pricing. The price. One commenter submitted inputs, pending anticipated RUC commenter submitted a series of new additional invoices for pricing these recommendations on the subject. invoices for endoscopy video system scopes and scope accessories.

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Response: We appreciate the database at this time. We will consider http://www.cms.gov/Medicare/ submission of this additional pricing the addition of these equipment items as Medicare-Fee-for-Service-Payment/ data for review. Although many part of the broader recommendations PhysicianFeeSched/PFS-Federal- commenters stated that the price of the from the RUC PE Subcommittee on the Regulation-Notices.html. stroboscopy system was too low, only scope classification project. For CY 2017, we proposed the one commenter supplied additional We did not receive an invoice or other following technical corrections: invoices for the same equipment item data to support a change in the pricing • For CPT codes 72081–72084, a that we defined in the proposed rule, of the fiberscope, flexible, stakeholder informed us that the the StrobeLED system, and these rhinolaryngoscopy (ES020). equipment time for the PACS invoices reflected lower prices than the Comment: Many commenters objected workstation (ED050) should be equal to one we had proposed. These invoices to the use of a vendor quote for pricing the clinical labor during the service reflected prices of $16,431.00 and of the scope equipment. Commenters period; the equipment time formula we $15,000.00. We are averaging these requested that specialty societies should used for these codes for CY 2016 together with our previously submitted also be allowed to submit quotes for erroneously included 4 minutes of price of $19,100.00 for the stroboscopy pricing as they are easier to obtain than preservice clinical labor. We agree with system, which results in a new price of paid invoices. Commenters also stated the stakeholder that the PACS $16,843.87. that the use of vendor prices created workstation should use the standard When we reviewed the invoices for transparency issues and asked CMS to equipment time formula for a PACS the channeled and non-channeled explain why they are appropriate to use workstation for these codes. As a result, flexible video rhinolaryngoscopes rather than invoices supplied by we proposed to refine the ED050 (ES064 and ES063 respectively), we specialties. One commenter stated that a equipment time to 21 minutes for CPT found that the product numbers single invoice was not an adequate code 72081, 36 minutes for CPT code indicated that these were different sample to use as a pricing input for 72082, 44 minutes for CPT code 72083, equipment items than the scopes that many types of endoscopic equipment. and 53 minutes for CPT code 72084 to we priced in the proposed rule. As we Response: We are always interested in reflect the clinical labor time associated mentioned for the pricing of the investigating multiple data sources for with these codes. This same commenter endoscopy video system, we have no use in pricing supplies and equipment, also indicated that a number of clinical data to indicate that use of these provided that the information can be labor activities had been entered in the particular rhinolaryngoscopes would be verified as accurate. We agree with the database in the incorrect service period typical, as opposed to the commenter that a single voluntarily for CPT codes 37215, 50432, 50694, and rhinolaryngoscopes that we proposed to submitted invoice may not be an 72081. These clinical labor activities use to establish prices in the proposed adequate source for making wide were incorrectly listed in the rule. As a result, we are maintaining our ranging pricing decisions. We prefer to ‘‘postservice’’ period instead of the current prices for these scopes pending have pricing information from multiple ‘‘service post’’ period. We proposed to the submission of additional data sources whenever possible, which make these technical corrections as well information. may include information obtained from so that the minutes are assigned to the We similarly found that the invoices vendors of medical supplies and appropriate service period within the with recommended price increases for equipment. We continue to believe that direct PE input database. the endoscope, rigid, sinoscopy (ES013) there are risks of bias in submission of • Another stakeholder alerted us that from the current price of $2,414.17 to price quotes used for purposes of ileoscopy CPT codes 44380, 44381 and $4,024.00 and for the videoscope, ratesetting. However, given the way we 44382 did not include the direct PE colonoscopy (ES033) from $23,650.00 to use these prices in the current input equipment item called the Gomco $37,273.00 related to different ratesetting methodologies, we believe suction machine (EQ235) and indicated equipment items that we do not believe the risk of bias is located in submission that this omission appeared to be are a better reflection of the typical case of overstated, not understated prices. inadvertent. We agreed that it was. We than the item we currently use. We did Therefore, we believe it is reasonable to have included the item EQ235 in the not propose to make price changes for assume that practitioners would final direct PE input database for CPT these scopes, and we have not generally be able acquire particular code 44380 at a time of 29 minutes, for incorporated these equipment items into items at the prices vendors submit to CPT code 44381 at a time of 39 minutes, the new scope classification system. As CMS. and CPT code 44382 at a time of 34 we stated previously, we are currently After consideration of comments minutes. limiting the scope changes to the CPT received, we are finalizing our proposals The PE RVUs displayed in Addendum codes under review for CY 2017 and as detailed in the proposed rule, with B on our Web site were calculated with their associated equipment items. We the updated prices for the endoscopy the inputs displayed in the CY 2017 will consider pricing changes for the video system and the stroboscopy direct PE input database. rest of the scopes and associated scope system. Comment: One commenter expressed equipment as part of the broader scope support for the proposed technical (4) Technical Corrections to Direct PE reclassification and pricing effort in corrections to these services. future rulemaking. Input Database and Supporting Files Response: We appreciate the support We received invoices for a series of Subsequent to the publication of the from the commenter. After equipment items listed as ‘‘other capital CY 2016 PFS final rule with comment consideration of comments received, we inputs not included in CMS estimate’’ period, stakeholders alerted us to are finalizing these technical as part of this collection of invoices. several clerical inconsistencies in the corrections. Since these equipment items were not direct PE database. We proposed to Comment: Several commenters included in the original correct these inconsistencies as contacted CMS during the comment recommendations or our proposed described below and reflected in the CY period after noticing that six services valuations for the Flexible Laryngoscope 2017 direct PE input database displayed where CMS proposed to accept the and Laryngoplasty families of codes, we on our Web site under downloads for refinement panel work RVU did not are not adding them to our equipment the CY 2017 PFS proposed rule at contain the updated work RVU in the

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Addendum B file for the proposed rule. understanding that xenon lights are no average price based on the invoices that These commenters requested that CMS longer the typical light source for these we received in total for the item. address these discrepancies. procedures and they are no longer Comment: Several commenters Response: We appreciate the widely available for purchase from supported the proposed price increase assistance from the commenters in vendors. The commenter expressed and urged CMS to finalize the proposal. recognizing these discrepancies. We support for retaining the xenon light as Response: We appreciate the support have corrected them and assigned the the standard light source line item for from the commenters. After refinement panel work RVUs to the six all endoscopy codes if that remained consideration of comments received, we services in question. CMS’ preference. are finalizing the price of the Antibody Comment: One commenter stated that Response: We appreciate the support Estrogen Receptor monoclonal (SL493) there were potential technical errors in for our proposal from the commenter, as supply at $14.00 as proposed. the clinical labor inputs for CPT codes well as the submission of additional We also proposed to update the price 88329, 88331, 88360, and 88361. information regarding the typical light for two supplies in response to the Response: We have reviewed these source for these procedures. We will submission of new invoices. The codes and they do not contain technical add the LED light source to our proposed price for ‘‘antigen, venom’’ errors. The clinical labor inputs were equipment database at the submitted supply (SH009) reflects an increase from adjusted in the CY 2016 rule cycle as a invoice price of $1,915.00. However, we $16.67 to $20.14 per milliliter, and the result of CMS refinement (80 FR 70981– will not replace the xenon light with the proposed price for ‘‘antigen, venom, tri- 70983). LED light at this time, as we believe the vespid’’ supply (SH010) reflects an increase from $30.22 to $44.05 per (5) Restoration of Inputs subject deserves further consideration. We will consider proposing this change milliliter. Several of the PE worksheets included in future rulemaking. Comment: Several commenters stated in the RUC recommendations for CY Comment: We received new invoices that they strongly supported the 2016 contained time for the equipment for the xenon light equipment from a proposed price updates for antigen item ‘‘xenon light source’’ (EQ167). different commenter which averaged out supplies and urged CMS to finalize the Because there appeared to be two to a price of $12,298.00. proposal. special light sources already present Response: We are finalizing our Response: We appreciate the support (the fiberoptic headlight and the proposed price of $7,000.00 for the from the commenters. After endoscope itself) in the services for xenon light source. Since we received a consideration of comments received, we which this equipment item was comment stating that xenon lights are are finalizing the price of the ‘‘antigen, recommended by the RUC, we believed no longer a typical light source for venom’’ (SH009) and ‘‘antigen, venom, that the use of only one of these light procedure use, and that they have been tri-vespid’’ (SH010) supplies as sources would be typical and proposed supplanted by the use of LED lights, we proposed. to remove the xenon light equipment are viewing the current input as a proxy We proposed to remove the laser tip, time. In the CY 2016 PFS final rule with item, and therefore, do not believe that diffuser fiber supply (SF030) and comment period, we restored the xenon it would be appropriate to increase the replace it with the laser tip, bare (single light (EQ167) and removed the cost of the xenon light source at this use) supply (SF029) for CPT code 31572 fiberoptic headlight (EQ170) with the time. We will consider making a (formerly placeholder code 317X1). We same number of equipment minutes for proposal to address this subject in did not propose a price change for the CPT codes 30300, 31295, 31296, 31297, future rulemaking. SF030 supply. and 92511. After consideration of comments Comment: In reference to CPT code We received comments expressing received, we are finalizing our proposal 52648, a commenter stated that the price approval for the restoration of the xenon to add the fiberoptic headlight (EQ170) for the laser tip, diffuser fiber supply light. However, the commenters also to CPT codes 30300, 31295, 31296, (SF030) was decreasing from $850 to stated that the two light sources were 31297, and 92511 at the same number $197.50. The commenter stated that the not duplicative, but rather, both a of equipment minutes as the xenon light methodology for this adjustment was headlight and a xenon light source are (EQ167). opaque, unanticipated, and not required concurrently for proposed for comment in the proposed otolaryngology procedures when scopes (6) Updates to Prices for Existing Direct rule. The commenter stated that the are utilized. The commenters requested PE Inputs $850 supply cost would be more that the fiberoptic headlight be restored In the CY 2011 PFS final rule with appropriate for the laser tip, diffuser to these codes. comment period (75 FR 73205), we fiber supply. We agreed with the commenters that finalized a process to act on public Response: We stated in the CY 2017 the use of both light sources would be requests to update equipment and proposed rule (81 FR 46247) that we did typical for these procedures. Therefore, supply price and equipment useful life not believe that the submitted invoice we proposed in the CY 2017 proposed inputs through annual rulemaking, for the laser tip, diffuser supply at rule to add the fiberoptic headlight beginning with the CY 2012 PFS $197.50 was current enough to establish (EQ170) to CPT codes 30300, 31295, proposed rule. For CY 2017, we a new price for the supply. As a result, 31296, 31297, and 92511 at the same proposed the following price updates we proposed to remove the laser tip, number of equipment minutes as the for existing direct PE inputs: diffuser fiber supply (SF030) and xenon light (EQ167). Several commenters wrote to discuss replaced it with the laser tip, bare Comment: One commenter expressed the price of the Antibody Estrogen (single use) supply (SF029) for CPT appreciation for the CMS proposal to Receptor monoclonal (SL493). We code 31572 (Laryngoscopy, flexible; restore the fiberoptic headlight to the received information including three with ablation or destruction of lesion(s) codes in question. The commenter also invoices with new pricing information with laser, unilateral), as we did not stated that it had supplied invoices for regarding the SL493 supply. We believe that it was appropriate to use a LED lights, which are significantly less proposed to use this information to supply with an outdated invoice. expensive than the xenon light source, propose for the supply item SL493 a However, we inadvertently set the price as it was this commenter’s price of $14.00 per test, which is the of the laser tip, diffuser fiber supply to

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$197.50 in the proposed direct PE input (7) Radiation Treatment Delivery cases, the change in specialty utilization database in contradiction of our written Practice Expense RVUs for a particular service would warrant a proposal. We apologize for the Comment: Several commenters re-examination of the direct PE inputs confusion caused by this error. In the noticed that there was a 10 percent for the service under the misvalued final direct PE input database, we are decrease in the proposed Non Facility code initiative. Given the statutory restoring the price of the laser tip, PE RVUs for HCPCS code G6011 despite provision that prohibits us from diffuser fiber supply to $850.00, since proposed changes in direct PE inputs. changing the direct PE inputs prior to we did not intend to propose a change Commenters requested an explanation CY 2019 or considering these services as the price of this supply. We are also for why this decrease was taking place, potentially misvalued, we will consider requesting the submission of additional and referenced section 3 of the Patient this issue further for future rulemaking. current pricing information for the laser Access and Medicare Protection Act We recognize that this change would tip, diffuser fiber supply, given the (PAMPA) (Pub. L. 114–115, enacted be unanticipated, but we do not believe significant difference between the December 18, 2015), which requires there is a straightforward, transparent $197.50 and $850.00 prices. CMS to maintain the associated way to offset the change since the statutory provision requires that we Comment: A commenter submitted ‘‘definitions, units, and inputs’’ for maintain the direct inputs for the PE two invoices containing pricing data for certain radiation treatment and related RVUs. We note that this change is a Cook Biopsy device. services for CY 2017 and CY 2018. Several commenters stated that they unique among the radiation therapy and Response: While we appreciate the believed that this decrease in the PE related imaging codes where the submission of this pricing information RVU was in violation of section maintenance of inputs has generally from the commenter, we are unable to 1848(c)(2)(C)(i–ii) of the Act (added by resulted in payment rate stability for determine which supply or equipment section 3 of the PAMPA), which these services. item these invoices were in reference to. requires inputs for these services to The invoices were not mentioned in the B. Determination of Malpractice remain unchanged for CY 2017 and Relative Value Units (RVUs) text of the commenter’s letter. We 2018. request that invoices submitted for Response: We agree with the 1. Overview pricing updates should contain clear commenters that we did not propose to Section 1848(c) of the Act requires documentation regarding the item in change any of the direct PE inputs for that each service paid under the PFS be question: its name, the CMS supply/ HCPCS code G6011, and we understand composed of three components: Work, equipment code that it references (if the proposed change in the nonfacility PE, and malpractice (MP) expense. As any), the unit quantity if the item is PE RVUs would generally not be required by section 1848(c)(2)(C)(iii) of shipped in boxes or batches, and any expected absent a corresponding change the Act, beginning in CY 2000, MP other information relevant for pricing. in direct PE inputs. However, the RVUs are resource based. Malpractice We routinely accept public change in the PE RVU for HCPCS code RVUs for new codes after 1991 were submission of invoices as part of our G6011 is caused by a significant shift in extrapolated from similar existing codes process for developing payment rates for the specialties furnishing the service in or as a percentage of the corresponding new, revised, and potentially misvalued the Medicare claims data. In the claims work RVU. Section 1848(c)(2)(B)(i) of codes. Often these invoices are data we used to establish the PE RVUs the Act also requires that we review, submitted in conjunction with the RUC- for CY 2016, dermatology furnished 51 and if necessary adjust, RVUs no less recommended values for the codes. For percent of the services, while radiation often than every 5 years. In the CY 2015 CY 2017, we note that some oncology furnished 43 percent. The PFS final rule with comment period, we stakeholders have submitted invoices most recent claims data reflects a major implemented the third review and for new, revised, or potentially shift, with radiation oncology now update of MP RVUs. For a misvalued codes after the February furnishing about 85 percent of the comprehensive discussion of the third deadline established for code valuation services and dermatology only about 6 review and update of MP RVUs see the recommendations. To be considered for percent. The decrease in the PE RVU CY 2015 proposed rule (79 FR 40349 a given year’s proposed rule, we between CY 2016 and CY 2017 resulted through 40355) and final rule with generally need to receive invoices by the from this shift in specialty mix, as the comment period (79 FR 67591 through same February deadline. In similar specialties actually furnishing the 67596). fashion, we generally need to receive service, reflected in the claims data, To determine MP RVUs for individual invoices by the end of the comment have a higher percentage of direct PE PFS services, our MP methodology is period for the proposed rule in order to relative to indirect PE, and therefore, a comprised of three factors: (1) Specialty- consider them for supply and lower percentage of indirect PE, than level risk factors derived from data on equipment pricing in the final rule for the specialties that were previously specialty-specific MP premiums that calendar year. Of course, we furnishing the service in the claims incurred by practitioners, (2) service consider invoices submitted as public data. In other words, consistent with the level risk factors derived from Medicare comments during the comment period established methodology for allocating claims data of the weighted average risk following the publication of the indirect PE to services, a specialty mix factors of the specialties that furnish proposed rule when relevant for with a lower percentage of indirect PE each service, and (3) an intensity/ services with values open for comment, results in fewer indirect PE RVUs being complexity of service adjustment to the and will consider any other invoices allocated and a lower overall PE RVU service level risk factor based on either received after February and/or outside for the code even though the direct PE the higher of the work RVU or clinical of the public comment process as part inputs have remained the same. This labor RVU. Prior to CY 2016, MP RVUs of our established annual process for kind of shift is relatively unusual were only updated once every 5 years, requests to update supply and outside of low-volume codes, but it is except in the case of new and revised equipment prices as finalized in the CY consistent with our established codes. 2011 final rule with comment period (75 methodology for allocating indirect PE As explained in the CY 2011 PFS final FR 73205). to services. We believe that in many rule with comment period (75 FR

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73208), MP RVUs for new and revised 2. Updating Specialty Specific Risk of the GPCI update, in advance of the codes effective before the next 5-year Factors next 5-year review of the MP RVUs, to review of MP RVUs were determined The proposed CY 2017 GPCI update propose updates to the specialty risk either by a direct crosswalk from a (eighth update), discussed in section II.E factors used in the calculation of MP similar source code or by a modified of this final rule, reflects updated MP RVUs. The commenter suggested that crosswalk to account for differences in premium data, collected for the purpose CMS consider using the updated data to work RVUs between the new/revised of proposing updates to the MP GPCIs. update the specialty-risk factors in the code and the source code. For the Although we could have used the MP RVU methodology as early as CY modified crosswalk approach, we adjust updated MP premium data obtained for 2018, noting that by CY 2018, the (or scale) the MP RVU for the new/ the purposes of the proposed eighth adjustment of the malpractice GPCIs revised code to reflect the difference in GPCI update to propose updates to the would be complete, so the potential work RVU between the source code and specialty risk factors used in the disconnect in the use of the updated the new/revised work RVU (or, if calculation of MP RVUs, this would not premium data would no longer be an greater, the difference in the clinical be consistent with the policy we issue. labor portion of the fully implemented previously finalized in the CY 2016 PFS Response: We appreciate the PE RVU) for the new code. For example, final rule with comment period. In that commenters’ feedback. In response to if the proposed work RVU for a revised rule, we indicated that the specialty- the commenters who recommended that code were 10 percent higher than the specific risk factors would continue to CMS use the updated MP premium data work RVU for its source code, the MP be updated through notice and comment collected as part of the CY 2017 GPCI RVU for the revised code would be rulemaking every 5 years using updated update in the creation of the MP RVUs increased by 10 percent over the source premium data, but would remain for CY 2017, we reiterate that we did not code MP RVU. Under this approach, the unchanged between the 5-year reviews. propose to update the specialty-risk same risk factor is applied for the new/ Additionally, consistent with the factors based on the new premium data revised code and source code, but the statutory requirement at section collected for the purposes of the 3-year work RVU for the new/revised code is 1848(e)(1)(C) of the Act, only one half of GPCI update for the CY 2017 MP RVUs. used to adjust the MP RVUs for risk. the adjustment to MP GPCIs would be Instead, we solicited comment on In the CY 2016 PFS final rule with applied for CY 2017 based on the new whether we should consider doing so comment period (80 FR 70906 through MP premium data. As such, we did not prior to the next 5-year interval, perhaps 70910), we finalized a policy to begin think it would be appropriate to propose as early as for CY 2018. We will conducting annual MP RVU updates to to update the specialty risk factors for consider the possibility of using the reflect changes in the mix of CY 2017 based on the updated MP updated MP data to update the specialty practitioners providing services (using premium data that is reflected in the risk factors used in the calculation of Medicare claims data), and to adjust MP proposed CY 2017 GPCI update. the MP RVUs prior to the next 5-year RVUs for risk for intensity and Therefore, we did not propose to update update in future rulemaking. complexity (using the work RVU or the specialty-risk factors based on the Comment: One commenter stated that clinical labor RVU). We also finalized a new premium data collected for the CPT code 93355 should be added to the policy to modify the specialty mix purposes of the 3-year GPCI update for MP RVUs Invasive Cardiology Outside assignment methodology (for both MP CY 2017 at this time. However, we of Surgical Range list so that the surgical and PE RVU calculations) to use an solicited comment on whether we risk factor is applied when calculating average of the 3 most recent years of should consider doing so, perhaps as the MP RVU. data instead of a single year of data. We early as for 2018, prior to the fourth Response: We did not previously stated that under this approach, the review and update of MP RVUs that propose to include this code on the list specialty-specific risk factors would must occur no later than CY 2020. of Invasive Cardiology Outside of continue to be updated through notice The following is summary of the Surgical Range when we updated MP and comment rulemaking every 5 years comments we received on whether we risk factors for CY 2015 and we did not using updated premium data, but would should consider updating the specialty- propose the change in the CY 2017 PFS remain unchanged between the 5-year risk factors based on the new premium proposed rule. We will consider that reviews. data collected for the purposes of the 3- request for future rulemaking in For CY 2016, we did not propose to year GPCI update, perhaps as early as conjunction with the next update of MP discontinue our current approach for for 2018, prior to the fourth review and risk factors. determining MP RVUs for new/revised update of MP RVUs that must occur no C. Medicare Telehealth Services codes. For the new and revised codes later than CY 2020. for which we proposed work RVUs and Comment: We received few comments 1. Billing and Payment for Telehealth PE inputs, we also published the regarding this issue. Some commenters, Services proposed MP crosswalks used to including the RUC, recommended that Several conditions must be met for determine their MP RVUs. We address CMS use the updated MP premium data Medicare to make payments for comments regarding valuation of new collected as part of the CY 2017 GPCI telehealth services under the PFS. The and revised codes in section II.L of this update in the creation of the MP RVUs service must be on the list of Medicare final rule, which makes clear the codes for CY 2017. One commenter stated that telehealth services and meet all of the with interim final values for CY 2016 CMS should follow its normal process following additional requirements: had newly proposed values for CY 2017, to update MP RVUs for CY 2020. • The service must be furnished via all of which were again open for Another commenter supported the an interactive telecommunications comment. The MP crosswalks for new technical and policy changes that CMS system. and revised codes with interim final made related to the MP RVUs for the CY • The service must be furnished by a values were established in the CY 2016 2016 PFS, and appreciated CMS’ physician or other authorized PFS final rule with comment period; we reluctance to change direction a year practitioner. proposed these same crosswalks in the later and use the updated malpractice • The service must be furnished to an CY 2017 PFS proposed rule. premium data gathered for the purpose eligible telehealth individual.

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• The individual receiving the service services, including the effective has been approved by, or received must be located in a telehealth communication requirements for funding from, the Secretary as of originating site. persons with disabilities of section 504 December 31, 2000 is eligible to be an When all of these conditions are met, of the Rehabilitation Act and language originating site regardless of its Medicare pays a facility fee to the access for persons with limited English geographic location. originating site and makes a separate proficiency, as required under Title VI Effective January 1, 2014, we also payment to the distant site practitioner of the Civil Rights Act of 1964. For more changed our policy so that geographic furnishing the service. information, see http://www.hhs.gov/ status for an originating site would be Section 1834(m)(4)(F)(i) of the Act ocr/civilrights/resources/specialtopics/ established and maintained on an defines Medicare telehealth services to hospitalcommunication. annual basis, consistent with other include professional consultations, Practitioners furnishing Medicare telehealth payment policies (78 FR office visits, office psychiatry services, telehealth services submit claims for 74400). Geographic status for Medicare and any additional service specified by telehealth services to the MACs that telehealth originating sites for each the Secretary, when furnished via a process claims for the service area calendar year is now based upon the telecommunications system. We first where their distant site is located. status of the area as of December 31 of implemented this statutory provision, Section 1834(m)(2)(A) of the Act the prior calendar year. which was effective October 1, 2001, in requires that a practitioner who For a detailed history of telehealth the CY 2002 PFS final rule with furnishes a telehealth service to an payment policy, see 78 FR 74399. comment period (66 FR 55246). We eligible telehealth individual be paid an 2. Adding Services to the List of established a process for annual updates amount equal to the amount that the Medicare Telehealth Services to the list of Medicare telehealth practitioner would have been paid if the services as required by section service had been furnished without the As noted previously, in the CY 2003 1834(m)(4)(F)(ii) of the Act in the CY use of a telecommunications system. PFS final rule (67 FR 79988), we 2003 PFS final rule with comment Originating sites, which can be one of established a process for adding services period (67 FR 79988). several types of sites specified in the to or deleting services from the list of As specified at § 410.78(b), we statute where an eligible telehealth Medicare telehealth services. This generally require that a telehealth individual is located at the time the process provides the public with an service be furnished via an interactive service is being furnished via a ongoing opportunity to submit requests telecommunications system. Under telecommunications system, are paid a for adding services. Under this process, § 410.78(a)(3), an interactive facility fee under the PFS for each we assign any qualifying request to telecommunications system is defined Medicare telehealth service. The statute make additions to the list of telehealth as multimedia communications specifies both the types of entities that services to one of two categories. equipment that includes, at a minimum, can serve as originating sites and the Revisions to criteria that we use to audio and video equipment permitting geographic qualifications for originating review requests in the second category two-way, real-time interactive sites. With regard to geographic were finalized in the CY 2012 PFS final communication between the patient and qualifications, § 410.78(b)(4) limits rule (76 FR 73102). The two categories distant site physician or practitioner. originating sites to those located in rural are: Telephones, facsimile machines, and health professional shortage areas • Category 1: Services that are similar stand-alone electronic mail systems do (HPSAs) or in a county that is not to professional consultations, office not meet the definition of an interactive included in a metropolitan statistical visits, and office psychiatry services that telecommunications system. An area (MSA). are currently on the list of telehealth interactive telecommunications system Historically, we have defined rural services. In reviewing these requests, we is generally required as a condition of HPSAs to be those located outside of look for similarities between the payment; however, section 1834(m)(1) MSAs. Effective January 1, 2014, we requested and existing telehealth of the Act allows the use of modified the regulations regarding services for the roles of, and interactions asynchronous ‘‘store-and-forward’’ originating sites to define rural HPSAs among, the beneficiary, the physician technology when the originating site is as those located in rural census tracts as (or other practitioner) at the distant site part of a federal telemedicine determined by the Federal Office of and, if necessary, the telepresenter, a demonstration program in Alaska or Rural Health Policy of the Health practitioner who is present with the Hawaii. As specified in § 410.78(a)(1), Resources and Services Administration beneficiary in the originating site. We asynchronous store-and-forward is the (HRSA) (78 FR 74811). Defining ‘‘rural’’ also look for similarities in the transmission of medical information to include geographic areas located in telecommunications system used to from an originating site for review by rural census tracts within MSAs allows deliver the service; for example, the use the distant site physician or practitioner for broader inclusion of sites within of interactive audio and video at a later time. HPSAs as telehealth originating sites. equipment. Medicare telehealth services may be Adopting the more precise definition of • Category 2: Services that are not furnished to an eligible telehealth ‘‘rural’’ for this purpose expands access similar to the current list of telehealth individual notwithstanding the fact that to health care services for Medicare services. Our review of these requests the practitioner furnishing the beneficiaries located in rural areas. includes an assessment of whether the telehealth service is not at the same HRSA has developed a Web site tool to service is accurately described by the location as the beneficiary. An eligible provide assistance to potential corresponding code when furnished via telehealth individual is an individual originating sites to determine their telehealth and whether the use of a enrolled under Part B who receives a geographic status. To access this tool, telecommunications system to furnish telehealth service furnished at a see the CMS Web site at https:// the service produces demonstrated telehealth originating site. www.cms.gov/Medicare/Medicare- clinical benefit to the patient. Submitted Practitioners furnishing Medicare General-Information/Telehealth/ evidence should include both a telehealth services are reminded that index.html. description of relevant clinical studies these services are subject to the same An entity participating in a federal that demonstrate the service furnished non-discrimination laws as other telemedicine demonstration project that by telehealth to a Medicare beneficiary

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improves the diagnosis or treatment of they are similar to services on the professional; first 30 minutes, face-to- an illness or injury or improves the existing telehealth list for the roles of, face with the patient, family member(s), functioning of a malformed body part, and interactions among, the beneficiary, or surrogate); and 99498 (advance care including dates and findings, and a list physician (or other practitioner) at the planning including the explanation and and copies of published peer reviewed distant site and, if necessary, the discussion of advance directives such as articles relevant to the service when telepresenter. As we stated in the CY standard forms (with completion of furnished via telehealth. Our 2012 final rule with comment period (76 such forms, when performed), by the evidentiary standard of clinical benefit FR 73098), we believe that the category physician or other qualified health care does not include minor or incidental 1 criteria not only streamline our review professional; each additional 30 minutes benefits. process for publicly requested services (list separately in addition to code for Some examples of clinical benefit that fall into this category, but also primary procedure)). include the following: expedite our ability to identify codes for We also received requests to add • Ability to diagnose a medical the telehealth list that resemble those services to the telehealth list that do not condition in a patient population services already on this list. meet our criteria for Medicare telehealth without access to clinically appropriate We received several requests in CY services. We did not propose to add the in-person diagnostic services. 2015 to add various services as following procedures for observation • Treatment option for a patient Medicare telehealth services effective care, emergency department visits, population without access to clinically for CY 2017. The following presents a critical care E/M, psychological testing, appropriate in-person treatment options. discussion of these requests, and our and physical, occupational and speech • Reduced rate of complications. decisions regarding additions to the CY therapy, for the reasons noted: • Decreased rate of subsequent 2017 telehealth list. Of the requests diagnostic or therapeutic interventions received, we found that four services a. Observation Care: CPT Codes— (for example, due to reduced rate of were sufficiently similar to ESRD- • 99217 (observation care discharge recurrence of the disease process). related services currently on the day management (this code is to be • Decreased number of future telehealth list to qualify on a category 1 utilized to report all services provided hospitalizations or physician visits. basis. Therefore, we proposed to add the to a patient on discharge from • More rapid beneficial resolution of following services to the telehealth list ‘‘observation status’’ if the discharge is the disease process treatment. on a category 1 basis for CY 2017: on other than the initial date of • Decreased pain, bleeding, or other • CPT codes 90967 (End-stage renal ‘‘observation status.’’ To report services quantifiable symptom. disease (ESRD) related services for to a patient designated as ‘‘observation • Reduced recovery time. dialysis less than a full month of status’’ or ‘‘inpatient status’’ and For the list of telehealth services, see service, per day; for patients younger discharged on the same date, use the the CMS Web site at https:// than 2 years of age; 90968 (End-stage codes for observation or inpatient care www.cms.gov/Medicare/Medicare- renal disease (ESRD) related services for services [including admission and General-Information/Telehealth/ dialysis less than a full month of discharge services, 99234–99236 as index.html. Requests to add services to service, per day; for patients 2–11 years appropriate.])); the list of Medicare telehealth services of age; 90969 (End-stage renal disease • 99218 (initial observation care, per must be submitted and received no later (ESRD) related services for dialysis less day, for the evaluation and management than December 31 of each calendar year than a full month of service, per day; for of a patient which requires these three to be considered for the next rulemaking patients 12–19 years of age); and 90970 key components: A detailed or cycle. For example, qualifying requests (End-stage renal disease (ESRD) related comprehensive history; a detailed or submitted before the end of CY 2016 services for dialysis less than a full comprehensive examination; and will be considered for the CY 2018 month of service, per day; for patients medical decision making that is proposed rule. Each request to add a 20 years of age and older). straightforward or of low complexity. service to the list of Medicare telehealth As we indicated in the CY 2015 final Counseling and coordination of care services must include any supporting rule with comment period (80 FR with other physicians, other qualified documentation the requester wishes us 41783), for the ESRD-related services health care professionals, or agencies to consider as we review the request. (CPT codes 90963–90966) added to the are provided consistent with the nature Because we use the annual PFS telehealth list for CY 2016, the required of the problem(s) and the patient’s and rulemaking process as a vehicle for clinical examination of the catheter family’s needs. Usually, the problem(s) making changes to the list of Medicare access site must be furnished face-to- requiring admission to ‘‘observation telehealth services, requesters should be face ‘‘hands on’’ (without the use of an status’’ are of low severity. Typically, 30 advised that any information submitted interactive telecommunications system) minutes are spent at the bedside and on is subject to public disclosure for this by a physician, CNS, NP, or PA. This the patient’s hospital floor or unit); purpose. For more information on requirement also applies to CPT codes • 99219 (initial observation care, per submitting a request for an addition to 90967–90970. day, for the evaluation and management the list of Medicare telehealth services, While we did not receive a specific of a patient, which requires these three including where to mail these requests, request, we also proposed to add two key components: A comprehensive see the CMS Web site at https:// advance care planning services to the history; a comprehensive examination; www.cms.gov/Medicare/Medicare- telehealth list. We have determined that and medical decision making of General-Information/Telehealth/ these services are similar to the annual moderate complexity. Counseling and index.html. wellness visits (HCPCS codes G0438 & coordination of care with other G0439) currently on the telehealth list: physicians, other qualified health care 3. Submitted Requests To Add Services • CPT codes 99497 (advance care professionals, or agencies are provided to the List of Telehealth Services for CY planning including the explanation and consistent with the nature of the 2017 discussion of advance directives such as problem(s) and the patient’s and Under our existing policy, we add standard forms (with completion of family’s needs. Usually, the problem(s) services to the telehealth list on a such forms, when performed), by the requiring admission to ‘‘observation category 1 basis when we determine that physician or other qualified health care status’’ are of moderate severity.

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Typically, 50 minutes are spent at the of the problem(s) and the patient’s and units provide safe, cost effective care to bedside and on the patient’s hospital family’s needs. Usually, the patient is patients that need ongoing evaluation floor or unit); unstable or has developed a significant and treatment beyond the emergency • 99220 (initial observation care, per complication or a significant new department visit by having reduced day, for the evaluation and management problem. Typically, 35 minutes are hospital admissions, shorter lengths of of a patient, which requires these three spent at the bedside and on the patient’s stay, increased safety and reduced cost. key components: A comprehensive hospital floor or unit); Additional studies cited indicated that history; a comprehensive examination; • 99234 (observation or inpatient observation units reduce the work load and medical decision making of high hospital care, for the evaluation and on emergency department physicians, complexity. Counseling and management of a patient including and reduce emergency department coordination of care with other admission and discharge on the same overcrowding. physicians, other qualified health care date, which requires these three key In the CY 2005 PFS proposed rule (69 professionals, or agencies are provided components: A detailed or FR 47510), we considered a request but consistent with the nature of the comprehensive history; a detailed or did not propose to add the observation problem(s) and the patient’s and comprehensive examination; and CPT codes 99217–99220 to the list of family’s needs. Usually, the problem(s) medical decision making that is Medicare telehealth services on a requiring admission to ‘‘observation straightforward or of low complexity. category two basis for the reasons status’’ are of high severity. Typically, Counseling and coordination of care described in that rule. The most recent 70 minutes are spent at the bedside and with other physicians, other qualified request did not include any information on the patient’s hospital floor or unit); health care professionals, or agencies • that would cause us to question the 99224 (subsequent observation care, are provided consistent with the nature previous evaluation under the category per day, for the evaluation and of the problem(s) and the patient’s and one criterion, which has not changed, management of a patient, which family’s needs. Usually the presenting regarding the significant differences in requires at least two of these three key problem(s) requiring admission are of patient acuity between these services components: Problem focused interval low severity. Typically, 40 minutes are and services on the telehealth list. history; problem focused examination; spent at the bedside and on the patient’s While the request included evidence of medical decision making that is hospital floor or unit); the general benefits of observation units, straightforward or of low complexity. • 99235 (observation or inpatient it did not include specific information Counseling and coordination of care hospital care, for the evaluation and demonstrating that the services with other physicians, other qualified management of a patient including described by these codes provided health care professionals, or agencies admission and discharge on the same clinical benefit when furnished via are provided consistent with the nature date, which requires these three key of the problem(s) and the patient’s and components: A comprehensive history; telehealth, which is necessary for us to family’s needs. Usually, the patient is a comprehensive examination; and consider these codes on a category two stable, recovering, or improving. medical decision making of moderate basis. Therefore, we did not propose to Typically, 15 minutes are spent at the complexity. Counseling and add these services to the list of bedside and on the patient’s hospital coordination of care with other approved telehealth services. floor or unit); physicians, other qualified health care b. Emergency Department Visits: CPT • 99225 (subsequent observation care, professionals, or agencies are provided Codes— per day, for the evaluation and consistent with the nature of the • management of a patient, which problem(s) and the patient’s and 99281 (emergency department visit requires at least two of these three key family’s needs. Usually the presenting for the evaluation and management of a components: An expanded problem problem(s) requiring admission are of patient, which requires these three key focused interval history; an expanded moderate severity. Typically, 50 components: A problem focused history; problem focused examination; medical minutes are spent at the bedside and on a problem focused examination; and decision making of moderate the patient’s hospital floor or unit); straightforward medical decision complexity. Counseling and • 99236 (observation or inpatient making. Counseling and coordination of coordination of care with other hospital care, for the evaluation and care with other physicians, other physicians, other qualified health care management of a patient including qualified health care professionals, or professionals, or agencies are provided admission and discharge on the same agencies are provided consistent with consistent with the nature of the date, which requires these three key the nature of the problem(s) and the problem(s) and the patient’s and components: A comprehensive history; patient’s and family’s needs. Usually, family’s needs. Usually, the patient is a comprehensive examination; and the presenting problem(s) are self- responding inadequately to therapy or medical decision making of high limited or minor); has developed a minor complication. complexity. Counseling and • 99282 (emergency department visit Typically, 25 minutes are spent at the coordination of care with other for the evaluation and management of a bedside and on the patient’s hospital physicians, other qualified health care patient, which requires these three key floor or unit); professionals, or agencies are provided components: An expanded problem • 99226 (subsequent observation care, consistent with the nature of the focused history; an expanded problem per day, for the evaluation and problem(s) and the patient’s and focused examination; and medical management of a patient, which family’s needs. Usually the presenting decision making of low complexity. requires at least two of these three key problem(s) requiring admission are of Counseling and coordination of care components: A detailed interval history; high severity. Typically, 55 minutes are with other physicians, other qualified a detailed examination; medical spent at the bedside and on the patient’s health care professionals, or agencies decision making of high complexity. hospital floor or unit); are provided consistent with the nature Counseling and coordination of care The request to add these observation of the problem(s) and the patient’s and with other physicians, other qualified services referenced various studies family’s needs. Usually, the presenting health care professionals, or agencies supporting the use of observation units. problem(s) are of low to moderate are provided consistent with the nature The studies indicated that observation severity);

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• 99283 (emergency department visit same as in a physician’s office; we adequate substitute for a face-to-face for the evaluation and management of a believe that, in general, more acutely ill encounter, based on the category 2 patient, which requires these three key patients are more likely to be seen in the criteria at the time of that request. We components: An expanded problem emergency department, and that had no evidence suggesting that the use focused history; an expanded problem difference is part of the reason there are of telehealth could be a reasonable focused examination; and medical separate codes describing evaluation surrogate for the face-to-face delivery of decision making of moderate and management visits in the this type of care. complexity. Counseling and Emergency Department setting. The The American Telemedicine coordination of care with other practice of emergency medicine often Association (ATA) submitted a new physicians, other qualified health care requires frequent and fast-paced patient request for CY 2016 that cited several professionals, or agencies are provided reassessments, rapid physician studies to support adding these services consistent with the nature of the interventions, and sometimes the on a category 2 basis. To qualify under problem(s) and the patient’s and continuous physician interaction with category 2, we would need evidence family’s needs. Usually, the presenting ancillary staff and consultants. This that the service furnished via telehealth problem(s) are of moderate severity); work is distinctly different from the is still described accurately by the • 99284 (emergency department visit pace, intensity, and acuity associated requested code and produces a clinical for the evaluation and management of a with visits that occur in the office or benefit for the patient via telehealth. patient, which requires these three key outpatient setting. Therefore, we did not However, in reviewing the information components: A detailed history; a propose to add these services to the list provided by the ATA and a study titled, detailed examination; and medical of approved telehealth services on a ‘‘Impact of an Intensive Care Unit decision making of moderate category one basis. Telemedicine Program on Patient complexity. Counseling and The requester did not provide any Outcomes in an Integrated Health Care coordination of care with other studies supporting the clinical benefit of System,’’ published July 2014 in JAMA physicians, other qualified health care managing emergency department Internal Medicine, which found no professionals, or agencies are provided patients with telehealth which is evidence that the implementation of consistent with the nature of the necessary for us to consider these codes ICU telemedicine significantly reduced problem(s) and the patient’s and on a category two basis. Therefore, we mortality rates or hospital length of stay, family’s needs. Usually, the presenting did not propose to add these services to which could be indicators of clinical problem(s) are of high severity, and the list of approved telehealth services benefit. Therefore, we stated that we do require urgent evaluation by the on a category two basis. not believe that the submitted evidence physician, or other qualified health care Many requesters of additions to the demonstrates a clinical benefit to professionals but do not pose an telehealth list urged us to consider the patients. Therefore, we did not propose immediate significant threat to life or potential value of telehealth for to add these services on a category 2 physiologic function); and providing beneficiaries access to needed basis to the list of Medicare telehealth • 99285 (emergency department visit expertise. We note that if clinical services for CY 2016 (80 FR 71061). for the evaluation and management of a guidance or advice is needed in the This year, requesters cited additional patient, which requires these three key emergency department setting, a studies to support adding critical care components within the constraints consultation may be requested from an services to the Medicare telehealth list imposed by the urgency of the patient’s appropriate source, including on a category 2 basis. Eight of the clinical condition and mental status: A consultations that are currently studies dealt with telestroke and one comprehensive history; a included on the list of telehealth with teleneurology. Telestroke is an comprehensive examination; and services. approach that allows a neurologist to medical decision making of high provide remote treatment to vascular c. Critical Care Evaluation and complexity. Counseling and stroke victims. Teleneurology offers Management: CPT Codes— coordination of care with other consultations for neurological problems physicians, other qualified health care • 99291 (critical care, evaluation and from a remote location. It may be professionals, or agencies are provided management of the critically ill or initiated by a physician or a patient, for consistent with the nature of the critically injured patient; first 30–74 conditions such as headaches, problem(s) and the patient’s and minutes); and 99292 (critical care, dementia, strokes, multiple sclerosis family’s needs. Usually, the presenting evaluation and management of the and epilepsy. problem(s) are of high severity and pose critically ill or critically injured patient; However, according to the literature, an immediate significant threat to life or each additional 30 minutes (list the management of stroke via telehealth physiologic function). separately in addition to code for requires more than a single practitioner In the CY 2005 PFS proposed rule (69 primary service). and is distinct from the work described FR 47510), we considered a request but We previously considered and by the above E/M codes, 99291 and did not propose to add the emergency rejected adding these codes to the list of 99292. One additional study cited department visit CPT codes 99281– Medicare telehealth services in the CY involved pediatric patients, while 99285 to the list of Medicare telehealth 2009 PFS final rule (74 FR 69744) on a another noted that the Department of services for the reasons described in that category 1 basis because, due to the Defense has used telehealth to provide rule. acuity of critically ill patients, we did critical care services to hospitals in The current request to add the not believe critical care services are Guam for many years. Another reference emergency department E/M services similar to any services on the current study indicated that consulting stated that the codes are similar to list of Medicare telehealth services. In intensivists thought that telemedicine outpatient visit codes (CPT codes that rule, we said that critical care consultations were superior to 99201–99215) that have been on the services must be evaluated as category telephone consultations. In all of these telehealth list since CY 2002. As we 2 services. Because we considered cases, we believe the evidence noted in the CY 2005 PFS final rule, critical care services under category 2, demonstrates that interaction between while the acuity of some patients in the we needed to evaluate whether these are these patients and distant site emergency department might be the services for which telehealth can be an practitioners can have clinical benefit.

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However, we do not agree that the kinds patient, under the circumstance when a Halstead-Reitan Neuropsychological of services described in the studies are qualified health care professional has Battery and Allied Procedures, or the those that are included in the above in-person responsibility for the patient Wisconsin Card Sorting Test (WCST), critical care E/M codes 99291 and but the patient benefits from additional that cannot be done via telehealth nor 99292. We note that CPT guidance services from a distant-site consultant is different than neurological tests done makes clear that a variety of other specially trained in providing critical for Parkinson’s disease, seizure services are bundled into the payment care services. We proposed limiting medication side effects, gait assessment, rates for critical care, including gastric these services to once per day per nor any of the many neurological intubations and vascular access patient. Like the other telehealth examinations done via telehealth with procedures among others We do not consultations, these services would be the approved outpatient office visit and believe these kinds of services are valued relative to existing E/M services. inpatient visit CPT codes currently on furnished via telehealth. Public More details on the new coding the telehealth list. As an example, comments, included cited studies, can (G0508 and G0509) and valuation for requesters indicated that the MPPI is be viewed at https:// these services are discussed in section administered by a computer, which www.regulations.gov/ II.L. of this final rule and the final RVUs generates a report that is interpreted by #!documentDetail;D=CMS-2015-0081- for this service are included in the clinical psychologist, and that the 0002. Therefore, we did not propose to Addendum B of this final rule, test requires no interaction between the add CPT codes 99291 or 99292 to the including a summary of the public clinician and the patient. list of Medicare telehealth services for comments we received and our We previously considered the request CY 2017. responses to the comments. Like the to add these codes to the Medicare However, we are persuaded by the other telehealth consultation codes, we telehealth list in the CY 2015 final rule requests that we recognize the potential proposed that these services would be with comment period (79 FR 67600). We benefit of critical care consultation added to the telehealth list and would decided not to add these codes, services that are furnished remotely. We be subject to the geographic and other indicating that these services are not note that there are currently codes on statutory restrictions that apply to similar to other services on the the telehealth list that could be reported telehealth services. telehealth list because they require close when consultation services are observation of how a patient responds. d. Psychological Testing: CPT Codes— furnished to critically ill patients. In We noted that the requesters did not consideration of these public requests, • 96101 (psychological testing submit evidence supporting the clinical we recognize that there may be greater (includes psychodiagnostic assessment benefit of furnishing these services via resource costs involved in furnishing of emotionality, intellectual abilities, telehealth so that we could evaluate these services relative to the existing personality and psychopathology, e.g., them on a category 2 basis. While we telehealth consultation codes. We also MMPI, Rorschach, WAIS), per hour of acknowledge that requesters believe that agree with the requesters that there may the psychologist’s or physician’s time, some of these tests require minimal, if be potential benefits of remote care by both face-to-face time administering any, interaction between the clinician specialists for these patients. For these tests to the patient and time interpreting and patient, we disagree. We continue reasons, we think it would be advisable these test results and preparing the to believe that successful completion of to create a coding distinction between report); the tests listed as examples in these telehealth consultations for critically ill • 96102 psychological testing codes require the clinical psychologist patients, for example stroke patients, (includes psychodiagnostic assessment to closely observe the patient’s relative to telehealth consultations for of emotionality, intellectual abilities, response, which cannot be performed other hospital patients. Such a coding personality and psychopathology, e.g., via telehealth. Some patient responses, distinction would allow us to recognize MMPI and WAIS), with qualified health for example, sweating and fine tremors, the additional resource costs in terms of care professional interpretation and may be missed when the patient and time and intensity involved in report, administered by technician, per examiner are not in the same room. furnishing such services, under the hour of technician time, face-to-face); Therefore, we did not propose to add conditions where remote, intensive • 96118 Neuropsychological testing these services to the list of Medicare consultation is required to provide (e.g., Halstead-Reitan telehealth services for CY 2017. access to appropriate care for the neuropsychological battery, Wechsler e. Physical and Occupational Therapy critically ill patient. We recognize that memory scales and Wisconsin card and Speech-Language Pathology the current set of E/M codes, including sorting test), per hour of the Services: CPT Codes— current CPT codes 99291 and 99292, psychologist’s or physician’s time, both may not adequately describe such face-to-face time administering tests to • 92507 (treatment of speech, services because current E/M coding the patient and time interpreting these language, voice, communication, and presumes that the services are occurring test results and preparing the report); auditory processing disorder; in-person, in which case the expert care and, individual); and, 92508 (treatment of would be furnished in a manner • 96119 Neuropsychological testing speech, language, voice, described by the current codes for (e.g., Halstead-Reitan communication, and auditory critical care. neuropsychological battery, Wechsler processing disorder; group, 2 or more Therefore, we proposed to make memory scales and Wisconsin card individuals); 92521 (evaluation of payment through new HCPCS codes sorting test), with qualified health care speech fluency (e.g., stuttering, G0508 and G0509, initial and professional interpretation and report, cluttering)); 92522 (evaluation of speech subsequent, used to describe critical administered by technician, per hour of sound production (e.g., articulation, care consultations furnished via technician time, face-to-face). phonological process, apraxia, telehealth. This new coding would Requesters indicated that there is dysarthria)); 92523 (evaluation of provide a mechanism to report an nothing in the Minnesota Multiphasic speech sound production (e.g., intensive telehealth consultation Personality Inventory (MMPI), the articulation, phonological process, service, initial or subsequent, for the Rorschach inkblot test, the Wechsler apraxia, dysarthria); with evaluation of critically ill patient, such as a stroke Adult Intelligence Scale (WAIS), the language comprehension and expression

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(e.g., receptive and expressive and/or trunk, each 15 minutes); 97761 telehealth services for CY 2017 on a language)); 92524 (behavioral and (prosthetic training, upper and lower category 1 basis. qualitative analysis of voice and extremity(s), each 15 minutes); and Comment: Many commenters also resonance); (evaluation of oral and 97762 (checkout for orthotic/prosthetic supported the proposal to make pharyngeal swallowing function); 92526 use, established patient, each 15 payment through new codes, initial and (treatment of swallowing dysfunction or minutes). subsequent, used to describe critical oral function for feeding); 92610 The statute defines who is an care consultations furnished via (evaluation of oral and pharyngeal authorized practitioner of telehealth telehealth. Commenters indicated that swallowing function); CPT codes 97001 services. Physical therapists, the codes will improve patient (physical therapy evaluation); 97002 occupational therapists and speech- outcomes and quality of care. (physical therapy re-evaluation); 97003 language pathologists are not authorized Response: We thank the commenters (occupational therapy evaluation); practitioners of telehealth under section for their support. We believe the new 97004 (occupational therapy re- 1834(m)(4)(E) of the Act, as defined in coding G0508 and G0509 would provide evaluation); 97110 (therapeutic section 1842(b)(18)(C) of the Act. a mechanism to report an intensive procedure, 1 or more areas, each 15 Because the above services are telehealth consultation service, initial or subsequent, for the critically ill patient, minutes; therapeutic exercises to predominantly furnished by physical for example a stroke patient, under the develop strength and endurance, range therapists, occupational therapists and circumstance when a qualified health of motion and flexibility); 97112 speech-language pathologists, we do not care professional has in-person (therapeutic procedure, 1 or more areas, believe it would be appropriate to add responsibility for the patient but the each 15 minutes; neuromuscular them to the list of telehealth services at this time. One requester suggested that patient benefits from additional services reeducation of movement, balance, from a distant-site consultant specially coordination, kinesthetic sense, posture, we can add telehealth practitioners without legislation, as evidenced by the trained in furnishing critical care or proprioception for sitting or standing services. After consideration of the activities); 97116 (therapeutic addition of nutritional professionals. However, we do not believe we have public comments received, we are procedure, 1 or more areas, each 15 finalizing our proposal to add these minutes; gait training (includes stair such authority and note that nutritional professionals are included as critical care consultation services to the climbing)); 97532 (development of list of Medicare telehealth services for cognitive skills to improve attention, practitioners in the definition at section 1834(b)(18)(C)(vi) of the Act, and thus, CY 2017 on a category 1 basis. We are memory, problem solving (includes finalizing these services as limited to compensatory training), direct (one-on- are within the statutory definition of telehealth practitioners. Therefore, we once per day per patient. one) patient contact, each 15 minutes); We are also finalizing our proposal to 97533 (sensory integrative techniques to did not propose to add these services to the list of Medicare telehealth services make payment for these critical care enhance sensory processing and consultation services through new codes promote adaptive responses to for CY 2017. In summary, we proposed to add the G0508 and G0509, initial and environmental demands, direct (one-on- following codes to the list of Medicare subsequent, used to describe critical one) patient contact, each 15 minutes); telehealth services beginning in CY care consultations furnished via 97535 (self-care/home management 2017 on a category 1 basis: telehealth. More details on the new training (e.g., activities of daily living • ESRD-related services 90967 coding and valuation for these services (adl) and compensatory training, meal through 90970. The required clinical are discussed in section II.L. of this final preparation, safety procedures, and examination of the catheter access site rule and the final RVUs for this service instructions in use of assistive must be furnished face-to-face ‘‘hands are included in Addendum B of this technology devices/adaptive equipment) on’’ (without the use of an interactive final rule. Like the other telehealth direct one-on-one contact, each 15 telecommunications system) by a consultation codes, we proposed and minutes); 97537 (community/work physician, CNS, NP, or PA. are finalizing that these services would reintegration training (e.g., shopping, • Advance care planning (CPT codes be added to the telehealth list and transportation, money management, 99497 and 99498). would be subject to the geographic and avocational activities or work • Telehealth Consultations for a other statutory restrictions that apply to environment/modification analysis, Patient Requiring Critical Care Services telehealth services. work task analysis, use of assistive (G0508 and G0509). Comment: Several commenters agreed technology device/adaptive equipment), The following is summary of the with our decision not to add direct one-on-one contact, each 15 comments we received regarding the psychological and neuropsychological minutes); 97542 (wheelchair proposed addition of services to the list testing services to the telehealth list, management (e.g., assessment, fitting, of Medicare telehealth services: noting that the face-to-face contact training), each 15 minutes); 97750 Comment: Many commenters between the psychologist or technician (physical performance test or supported one or more of our proposals and the beneficiary is critical for measurement (e.g., musculoskeletal, to add ESRD-related services (CPT codes detecting behaviors related to test functional capacity), with written 90967, 90968, 90969 and 90970) and taking, such as movements or other report, each 15 minutes); 97755 advance care planning services (CPT nonverbal signals that could be missed (assistive technology assessment (e.g., to codes 99497 and 99498) to the list of by using current telehealth media. restore, augment or compensate for Medicare telehealth services for CY A few commenters disagreed with our existing function, optimize functional 2017. decision not to add psychological and tasks and maximize environmental Response: We appreciate the neuropsychological testing services. accessibility), direct one-on-one contact, commenters’ support for the proposed Commenters cited general benefits, such with written report, each 15 minutes); additions to the list of Medicare as increased access to care, improved 97760 Orthotic(s) management and telehealth services. After consideration health outcomes, and as a remedy to training (including assessment and of the public comments received, we are address provider shortages. One fitting when not otherwise reported), finalizing our proposal to add these commenter maintained that the upper extremity(s), lower extremity(s) services to the list of Medicare requested codes are similar to many

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neurological examinations done via outpatient setting. Commenters Our requirement for physicians and telehealth with the approved outpatient provided no evidence of clinical benefit practitioners to use the telehealth POS office visit and inpatient visit CPT codes for these services when furnished via code to report that telehealth services currently on the telehealth list. telehealth specifically, which is were furnished from a distant site Response: As noted above, we necessary to support adding these would improve payment accuracy and previously considered the request to services on a category 2 basis. Therefore, consistency in telehealth claims add these codes to the telehealth list, on we are not adding these services to the submission. Currently, for services a category 1 basis, in the CY 2015 final list of Medicare telehealth services for furnished via telehealth, we have rule with comment period (79 FR CY 2017. instructed practitioners to report the 67600). We decided not to add these We remind stakeholders that if POS code that would have been codes, indicating that these services are consultative telehealth services are reported had the service been furnished not similar to other services on the required for patients where emergency in person. However, some practitioners telehealth list because they require close department or observation care services use the POS where they are located observation of how a patient responds. would ordinarily be reported, multiple when the service is furnished, while Commenters provided no evidence of codes describing consultative services others use the POS corresponding to the clinical benefit, which is necessary to are currently on the telehealth list and patient’s location. support adding these services on a can be used to bill for such telehealth Under the PFS, the POS code category 2 basis. Therefore, we are not services. determines whether a service is paid Comment: Concerning various adding these services to the list of using the facility or non-facility practice Medicare list telehealth services for CY services primarily furnished by physical expense relative value units (PE RVUs). 2017. therapists, occupational therapists, and The facility rate is paid when a service Comment: A few commenters speech-language pathologists, disagreed with our decision not to add commenters recognized that a statutory is furnished in a location where observation care and emergency change is required to allow such Medicare is making a separate facility department visits. Commenters cited services to be added to the list of payment to an entity other than the general benefits, such as improved Medicare telehealth services. physician or practitioner that is quality of care, reduced physician Response: We appreciate commenters intended to reflect the facility costs workload, reduced emergency recognizing the statutory limitation on associated with the service (clinical department overcrowding, and reduced adding these services. Therefore, we are staff, supplies and equipment). We note shortage of available specialty services. not adding these services to the list of that in accordance with section Concerning CPT codes 99281–99283, Medicare telehealth services for CY 1834(m)(2)(B) of the Act, the payment one commenter indicated that none of 2017. amount for the telehealth facility fee these codes include what is categorized paid to the originating site is a national 4. Place of Service (POS) Code for fee, paid without geographic or site of as a ‘‘detailed’’ or ‘‘comprehensive’’ Telehealth Services history or exam; none of these codes service adjustments that generally are include complexity in medical decision We have received multiple requests made for payments to different kinds of making that is categorized as ‘‘high;’’ from various stakeholders to establish a Medicare providers and suppliers. In and none of these codes include POS code to identify services furnished the case of telehealth services, we presenting problems of ‘‘high’’ or ‘‘high via telehealth. These requests have believe that facility costs (clinical staff, severity/immediate significant threat to come from other payers, but may also be supplies, and equipment) associated life or physiological function.’’ related to confusion concerning whether with furnishing the service would Response: As noted above, we to use the POS where the distant site generally be incurred by the originating previously considered and rejected physician is located or the POS where site, where the patient is located, and adding these codes to the list of the patient is located. The process for not by the practitioner at the distant Medicare telehealth services in the CY establishing POS codes is managed by site. The statute requires Medicare to 2005 PFS final rule (69 FR 66276) on a the POS Workgroup within CMS, is pay a fee to the site that hosts the category 1 basis because of the available for use by all payers, and is patient. This is analogous to the difference in typical patient acuity not contingent upon Medicare PFS circumstances under which the facility relative to any services on the current rulemaking. We noted in the CY 2017 PE RVUs are used to pay for services list of Medicare telehealth services. proposed rule (81 FR 46184) that, if under the PFS. Therefore, we proposed While CPT codes 99281–99283 may not such a POS code were created, in order to use the facility PE RVUs to pay for include a detailed or comprehensive to make it valid for use in Medicare, we telehealth services reported by history or exam or a high level of would have to determine the physicians or practitioners with the medical decision making, we do not appropriate payment rules associated telehealth POS code. We note that there agree that these codes are similar to with the code. Therefore, we proposed are only three codes on the telehealth outpatient visit codes (CPT codes how a POS code for telehealth would be list with a difference greater than 1.0 PE 99201–99215) currently on the list of used under the PFS with the RVUs between the facility PE RVUs and Medicare telehealth services. As expectation that, if such a code is the non-facility PE RVUs. We did not previously stated, more acutely ill available, it would be used as early as anticipate that this proposal would patients are more likely to be seen in the January 1, 2017. We proposed that the result in a significant change in the total emergency department, and that physicians or practitioners furnishing payment for the majority of services on difference is part of the reason there are telehealth services would be required to the telehealth list. Moreover, many separate codes describing evaluation report the telehealth POS code to practitioners already use a facility POS and management visits in the indicate that the billed service is when billing for telehealth services Emergency Department setting. The furnished as a telehealth service from a (those that report the POS of the work in an Emergency Department distant site. As noted below, since the originating site where the beneficiary is setting is distinctly different from the publication of the CY 2017 proposed located). The policy to use the pace, intensity, and acuity associated rule, the telehealth POS code has been telehealth POS code for telehealth with visits that occur in the office or created. services would not affect payment for

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telehealth services for these telehealth. We have had longstanding required use of the GT and GQ practitioners. HCPCS modifiers for telehealth. While telehealth modifiers, and we may revisit The POS code for telehealth would these modifiers were not adopted by this question through future rulemaking. not apply to originating sites billing the CPT, they have been available for use by Like the modifiers, use of the POS code facility fee. Originating sites are not other payers. Despite the availability of certifies that the service meets the furnishing a service via telehealth since these HCPCS modifiers noting telehealth requirements. Distant site the patient is physically present in the telehealth services, payers have providers will be paid using the facility facility. Accordingly, the originating site requested creation of the new POS code. PE RVUs, regardless of their location. would continue to use the POS code Therefore, we do not understand why The setting of the patient does not affect that applies to the type of facility where introduction of a new CPT modifier as the payment to the distant site provider. the patient is located. opposed to a HCPCS modifier would Comment: Commenters also asked for We also proposed a change to obviate the need for a POS code. clarification that the proposal to adopt § 414.22(b)(5)(i)(A) that addresses the PE Instead, we agree with other payers that the telehealth POS relates solely to RVUs used in different settings. These the POS code would provide payment, and not to licensure revisions would improve clarity consistency in reporting and identifying requirements. The commenter noted regarding our current policies. services furnished via telehealth, since that practitioners who furnish telehealth Specifically, we proposed to amend this it eliminates the need for service- services must adhere to the standard of section to specify that the facility PE specific rules regarding appropriate POS care and licensure rules, regulations and RVUs are paid for practitioner services reporting for telehealth services. laws of the state where the patient is furnished via telehealth under § 410.78. Comment: Another commenter stated located, just as the practitioner would in In addition, we proposed a change to that use of the POS code, or originating a traditional face-to-face encounter. resolve any potential ambiguity and site restrictions, would place additional Response: The commenters are correct clarify that payment under the PFS is administrative barriers for that the purpose of our POS proposal is made at the facility rate (facility PE telepsychiatric access. to assist in determining proper payment. Response: We note that the POS is a RVUs) when services are furnished in a It will also help us to accurately track facility setting paid by Medicare, required field on the professional claim, telehealth utilization and spending. The including in off-campus provider based regardless of whether the service is proposal to adopt the telehealth POS departments. As proposed, the furnished via telehealth. Since a code has no bearing on state licensure regulation reflected the policy being selection needs to be made, we believe requirements or other state regulations. proposed, for CY 2017 only, to pay the that requiring the selection of a specific We appreciate the commenters’ request physician the nonfacility rate for code is no more burdensome than for clarification. services furnished in an off-campus requiring the claim to specify the POS Comment: Several commenters provider based department that was not appropriate to either the setting of the supported the proposal to use the excepted under section 603 of the telehealth patient or the setting of the facility PE RVUs for telehealth services. Bipartisan Budget Act of 2015. Finally, distant site practitioner. The POS code One commenter said paying some to streamline the existing regulation, we does not entail any new originating site telehealth services at non-facility rates also proposed to delete § 414.32 of our restrictions. creates undesirable financial incentives regulation that refers to the calculation Comment: Various commenters asked to prefer telehealth services over of payments for certain services prior to for clarification of the following: services that are furnished in person at 2002. • Whether the POS code would The following is summary of the replace the GT modifier. the originating site. comments we received regarding the • Whether the description of Response: We appreciate the support proposal to use a POS code for services telehealth as a service furnished via an for the proposal and agree with the furnished via telehealth: interactive audio and video commenter’s articulation regarding the Comment: Many commenters telecommunications system applies to importance of developing payment rates supported the proposal to use the POS the POS code as it does to the GT that reflect the relative resource costs of code for telehealth, indicating that it modifier. furnishing the services and that do not would clarify and simplify billing • How to ensure proper payment create unintended financial incentives. requirements, improve payment when the distant site practitioner is at Comment: Many other commenters accuracy and consistency in telehealth a facility, but the patient is not. opposed the proposal. Commenters claims submissions, and provide more Response: Under current policy, use stated that it would result in lower fees reliable data regarding telehealth of the GT and GQ modifiers certifies for telehealth services furnished by services. that the service meets the telehealth psychologists. Commenters also stated Response: We appreciate the support requirements, and would continue to be that PE costs increase for services for this proposal. required. The POS code would be used furnished via telehealth due to the costs Comment: One commenter asked us in addition to the GT and GQ modifiers. of HIPAA-compliant telecommunication to reconsider the proposal, noting that We did not propose to implement a equipment. the AMA’s CPT Editorial Panel has change in the requirement to use either One commenter remarked that use of adopted a telehealth modifier for those the GT and GQ modifier because at the a POS code should not be the basis for medical services that are currently time of the proposed rule, we did not reducing payments and that many codes covered telehealth services by Medicare know whether the telehealth POS code would experience a significant payment or other payers, which obviates the need would be made effective for January 1, change. The commenter noted that a 1.0 for the POS code. 2017. However, because under our RVU reduction would result in a $36 Response: The POS code was proposal the POS code would serve to payment reduction for the service. One requested by other payers, and we identify telehealth services furnished commenter stated CMS should propose continue to believe that adopting it for under section 1834(m) of the Act via an budget neutral PE and originating site use in the Medicare program would interactive audio and video fees, based on data, for CY 2018. One provide consistency in reporting and telecommunications system, we believe commenter noted that there are no identifying services furnished via that we should consider eliminating the facility PE RVUs for several codes.

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Response: We do not believe that use our proposal to use the POS code for finalizing the proposal to delete § 414.32 of the telehealth POS code produces a telehealth and to use the facility PE of our regulation that refers to the significant payment change in the vast RVUs to pay for telehealth service calculation of payments for certain majority of circumstances. For distant reported by physicians or practitioners services prior to 2002. site practitioners who are already paid with the telehealth POS code for CY We remind the public that we are using the facility PE RVUs and for 2017. However, we understand currently soliciting requests to add services where there is no payment commenters’ concerns and will consider services to the list of Medicare difference between the facility and non- the concerns regarding use of the facility telehealth services. To be considered facility PE RVUs, there will be no payment rate as we monitor utilization during PFS rulemaking for CY 2018, change in payment as a result of the of telehealth services. We will welcome these requests must be submitted and telehealth POS code. information from stakeholders regarding received by December 31, 2016. Each There is utilization data for 56 of the any potential unintended consequences request to add a service to the list of 81 codes on the telehealth list. For these of the payment policy. We will also Medicare telehealth services must codes, 20 are not paid differently based consider the applicability of the facility include any supporting documentation on site of service, and 27 codes are paid rate to any codes newly added to the list the requester wishes us to consider as differently by fewer than 0.5 RVUs. of telehealth services. we review the request. For more There are only three codes on the We have updated the POS code list on information on submitting a request for telehealth list with a difference greater our Web site at https://www.cms.gov/ an addition to the list of Medicare than 1.0 PE RVUs between the facility Medicare/Coding/place-of-service- telehealth services, including where to PE RVUs and the non-facility PE RVUs. codes/Place_of_Service_Code_Set.html mail these requests, we refer readers to Concerning psychotherapy and to include POS 02: Telehealth the CMS Web site at https:// psychological testing services, we note (Descriptor: The location where health www.cms.gov/Medicare/Medicare- that for the vast majority of psychiatric services and health related services are General-Information/Telehealth/ services the difference between the two provided or received, through index.html. rates is very small. For example, the telecommunication technology). The difference between the facility and non- new code will be used for services 5. Telehealth Originating Site Facility facility national rates for 45 minutes of furnished on or after January 1, 2017. Fee Payment Amount Update psychotherapy is 0.02 RVUs per service: We are finalizing proposed revisions Section 1834(m)(2)(B) of the Act Less than $1.00. The differences to our regulation at § 414.22(b)(5)(i)(A) establishes the Medicare telehealth between the facility PE RVUs and non- that addresses the PE RVUs used in originating site facility fee for telehealth facility PE RVUS ranges from 0.01–0.03 different settings as described above, services furnished from October 1, 2001 RVUs for nine of the psychological except that we are not finalizing the through December 31, 2002, at $20.00. testing codes on the Medicare telehealth proposed change that would have For telehealth services furnished on or list, and 0.12 RVUs lower for two other resulted in the payment of the after January 1 of each subsequent codes. We do not consider these nonfacility rate for services furnished in calendar year, the telehealth originating reductions significant, nor do we have off-campus provider based departments site facility fee is increased by the any evidence that practice expense costs that are not excepted under Section 603 percentage increase in the MEI as are greater for furnishing such services of the Bipartisan Budget Act of 2015 defined in section 1842(i)(3) of the Act. via telehealth than for furnishing a face- since we are finalizing that payments to The originating site facility fee for to-face service. Commenters provided such non-excepted PBDs will be made telehealth services furnished in CY 2016 no evidence that practice expense costs under the PFS. In a separate interim is $25.10. The MEI increase for 2017 is for services furnished via telehealth are final rule with comment period issued 1.2 percent and is based on the most greater, due to the requirement for in conjunction with the CY 2017 OPPS/ recent historical update through 2016Q2 HIPAA-compliant equipment, than for ASC final rule with comment period (1.6 percent), and the most recent furnishing in-person services, even in (see Medicare Program: Hospital historical MFP through calendar year the facility setting. Outpatient Prospective Payment and 2015 (0.4 percent). Therefore, for CY There are a few HCPCS codes on the Ambulatory Surgical Center Payment 2017, the payment amount for HCPCS telehealth list that do not have a Systems and Quality Reporting code Q3014 (Telehealth originating site calculated facility PE RVU. For these Programs; Organ Procurement facility fee) is 80 percent of the lesser of services, the non-facility PE RVUs Organization Reporting and the actual charge or $25.40. The would serve as a proxy, and therefore, Communication; Transplant Outcome Medicare telehealth originating site there would be no payment change for Measures and Documentation facility fee and the MEI increase by the these codes. Requirements; Electronic Health Record applicable time period is shown in Finally, we note that the originating (EHR) Incentive Programs; Payment to Table 6. site facility fee is established by statute Certain Off-Campus Outpatient (section 1834(m)(2)(B) of the Act) and is Departments of a Provider; Hospital TABLE 6—THE MEDICARE TELEHEALTH not affected by this proposal. Value-Based Purchasing (VBP) Program; ORIGINATING SITE FACILITY FEE AND We note that we believe that payment Establishment of Physician Fee MEI using the facility PE RVUs for telehealth Schedule Payment Rates for services is consistent our belief that the Nonexcepted Items and Services Billed [Increase by the applicable time period] direct practice expense costs are by Applicable Departments of a MEI Facility generally incurred at the location of the Hospital), we are finalizing other Time period increase fee payment policies for nonexcepted items beneficiary and not by the distant site 10/01/2001–12/31/2002 ...... N/A $20.00 practitioner. After reviewing the current and services furnished by such non- 01/01/2003–12/31/2003 ...... 3.0 20.60 list of telehealth services in the context excepted off-campus provider based 01/01/2004–12/31/2004 ...... 2.9 21.20 of the comments, we continue to believe departments. Accordingly, physicians 01/01/2005–12/31/2005 ...... 3.1 21.86 01/01/2006–12/31/2006 ...... 2.8 22.47 this is accurate. furnishing services in such provider- 01/01/2007–12/31/2007 ...... 2.1 22.94 After consideration of the public based departments will continue to be 01/01/2008–12/31/2008 ...... 1.8 23.35 comments received, we are finalizing paid the facility rate. We are also 01/01/2009–12/31/2009 ...... 1.6 23.72

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TABLE 6—THE MEDICARE TELEHEALTH recommendations submitted to us by • Codes that have experienced the ORIGINATING SITE FACILITY FEE AND the RUC for our review. We also fastest growth. • MEI—Continued consider information provided by other Codes that have experienced [Increase by the applicable time period] stakeholders. We conduct a review to substantial changes in practice assess the appropriate RVUs in the expenses. • Codes that describe new Time period MEI Facility context of contemporary medical increase fee practice. We note that section technologies or services within an 01/01/2010–12/31/2010 ...... 1.2 24.00 1848(c)(2)(A)(ii) of the Act authorizes appropriate time period (such as 3 01/01/2011–12/31/2011 ...... 0.4 24.10 the use of extrapolation and other years) after the relative values are 01/01/2012–12/31/2012 ...... 0.6 24.24 techniques to determine the RVUs for initially established for such codes. 01/01/2013–12/31/2013 ...... 0.8 24.43 • Codes which are multiple codes 01/01/2014–12/31/2014 ...... 0.8 24.63 physicians’ services for which specific 01/01/2015–12/31/2015 ...... 0.8 24.83 data are not available and requires us to that are frequently billed in conjunction 01/01/2016–12/31/2016 ...... 1.1 25.10 take into account the results of with furnishing a single service. 01/01/2017–12/31/2017 ...... 1.2 25.40 consultations with organizations • Codes with low relative values, representing physicians who provide particularly those that are often billed D. Potentially Misvalued Services Under the services. In accordance with section multiple times for a single treatment. • the Physician Fee Schedule 1848(c) of the Act, we determine and Codes that have not been subject to 1. Background make appropriate adjustments to the review since implementation of the fee RVUs. schedule. Section 1848(c)(2)(B) of the Act • In its March 2006 Report to the Codes that account for the majority directs the Secretary to conduct a of spending under the physician fee periodic review, not less often than Congress (http://www.medpac.gov/ documents/reports/Mar06_ schedule. every 5 years, of the RVUs established • Codes for services that have EntireReport.pdf?sfvrsn=0), MedPAC under the PFS. Section 1848(c)(2)(K) of experienced a substantial change in the discussed the importance of the Act requires the Secretary to hospital length of stay or procedure appropriately valuing physicians’ periodically identify potentially time. services, noting that misvalued services misvalued services using certain criteria • Codes for which there may be a can distort the market for physicians’ and to review and make appropriate change in the typical site of service services, as well as for other health care adjustments to the relative values for since the code was last valued. those services. Section 1848(c)(2)(L) to services that physicians order, such as • Codes for which there is a the Act also requires the Secretary to hospital services. In that same report significant difference in payment for the develop a process to validate the RVUs MedPAC postulated that physicians’ same service between different sites of of certain potentially misvalued codes services under the PFS can become service. under the PFS, using the same criteria misvalued over time. MedPAC stated, • Codes for which there may be used to identify potentially misvalued ‘‘When a new service is added to the anomalies in relative values within a codes, and to make appropriate physician fee schedule, it may be family of codes. adjustments. assigned a relatively high value because • Codes for services where there may As discussed in section II.B. of this of the time, technical skill, and be efficiencies when a service is final rule, each year we develop psychological stress that are often furnished at the same time as other appropriate adjustments to the RVUs required to furnish that service. Over services. taking into account recommendations time, the work required for certain • Codes with high intra-service work provided by the American Medical services would be expected to decline as per unit of time. Association/Specialty Society Relative physicians become more familiar with • Codes with high practice expense Value Scale Update Committee (RUC), the service and more efficient in relative value units. the Medicare Payment Advisory furnishing it.’’ We believe services can • Codes with high cost supplies. Commission (MedPAC), and others. For also become overvalued when PE • Codes as determined appropriate by many years, the RUC has provided us declines. This can happen when the the Secretary. with recommendations on the costs of equipment and supplies fall, or Section 1848(c)(2)(K)(iii) of the Act appropriate relative values for new, when equipment is used more also specifies that the Secretary may use revised, and potentially misvalued PFS frequently than is estimated in the PE existing processes to receive services. We review these methodology, reducing its cost per use. recommendations on the review and recommendations on a code-by-code Likewise, services can become appropriate adjustment of potentially basis and consider these undervalued when physician work misvalued services. In addition, the recommendations in conjunction with increases or PE rises. Secretary may conduct surveys, other analyses of other data, such as claims As MedPAC noted in its March 2009 data collection activities, studies, or data, to inform the decision-making Report to Congress (http:// other analyses, as the Secretary process as authorized by the law. We www.medpac.gov/documents/reports/ determines to be appropriate, to may also consider analyses of work march-2009-report-to-congress- facilitate the review and appropriate time, work RVUs, or direct PE inputs medicare-payment-policy.pdf?sfvrsn=0), adjustment of potentially misvalued using other data sources, such as in the intervening years since MedPAC services. This section also authorizes Department of Veteran Affairs (VA), made the initial recommendations, CMS the use of analytic contractors to National Surgical Quality Improvement and the RUC have taken several steps to identify and analyze potentially Program (NSQIP), the Society for improve the review process. Also, misvalued codes, conduct surveys or Thoracic Surgeons (STS), and the section 1848(c)(2)(K)(ii) of the Act collect data, and make Physician Quality Reporting System augments our efforts by directing the recommendations on the review and (PQRS) databases. In addition to Secretary to specifically examine, as appropriate adjustment of potentially considering the most recently available determined appropriate, potentially misvalued services. Additionally, this data, we also assess the results of misvalued services in the following section provides that the Secretary may physician surveys and specialty categories: coordinate the review and adjustment of

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any RVU with the periodic review the fourth Five-Year Review (76 FR PFS final rule with comment period described in section 1848(c)(2)(B) of the 32410), we requested recommendations (73054 through 73055). Act. Section 1848(c)(2)(K)(iii)(V) of the from the RUC to aid in our review of We contracted with two outside Act specifies that the Secretary may Harvard-valued codes with annual entities to develop validation models for make appropriate coding revisions utilization of greater than 30,000. In the RVUs. (including using existing processes for CY 2013 PFS final rule with comment consideration of coding changes) that period, we identified specific Harvard- Given the central role of time in may include consolidation of individual valued services with annual allowed establishing work RVUs and the services into bundled codes for payment charges that total at least $10,000,000 as concerns that have been raised about the under the physician fee schedule. potentially misvalued. In addition to the current time values used in rate setting, we contracted with the Urban Institute 2. Progress in Identifying and Reviewing Harvard-valued codes, in the CY 2013 Potentially Misvalued Codes PFS final rule with comment period we to develop empirical time estimates finalized for review a list of potentially based on data collected from several To fulfill our statutory mandate, we misvalued codes that have stand-alone health systems with multispecialty have identified and reviewed numerous PE (codes with physician work and no group practices. The Urban Institute potentially misvalued codes as specified listed work time and codes with no collected data by directly observing the in section 1848(c)(2)(K)(ii) of the Act, physician work that have listed work delivery of services and through the use and we plan to continue our work time). of electronic health records for services examining potentially misvalued codes In the CY 2016 PFS final rule with in these areas over the upcoming years. selected by the contractor in comment period, we finalized for As part of our current process, we consultation with CMS and is using this review a list of potentially misvalued identify potentially misvalued codes for data to produce objective time services, which included eight codes in review, and request recommendations estimates. We expect the final Urban the neurostimulators analysis- from the RUC and other public Institute report will be made available programming family (CPT 95970– commenters on revised work RVUs and on the CMS Web site later this year. 95982). We also finalized as potentially direct PE inputs for those codes. The misvalued 103 codes identified through The second contract is with the RAND RUC, through its own processes, also our screen of high expenditure services Corporation, which used available data identifies potentially misvalued codes across specialties. to build a validation model to predict for review. Through our public work RVUs and the individual nomination process for potentially 3. Validating RVUs of Potentially components of work RVUs, time and misvalued codes established in the CY Misvalued Codes intensity. The model design was 2012 PFS final rule with comment Section 1848(c)(2)(L) of the Act informed by the statistical period, other individuals and methodologies and approach used to stakeholder groups submit nominations requires the Secretary to establish a formal process to validate RVUs under develop the initial work RVUs and to for review of potentially misvalued identify potentially misvalued codes as well. the PFS. The Act specifies that the Since CY 2009, as a part of the annual validation process may include procedures under current CMS and RUC potentially misvalued code review and validation of work elements (such as processes. RAND consulted with a Five-Year Review process, we have time, mental effort and professional technical expert panel on model design reviewed over 1,671 potentially judgment, technical skill and physical issues and the test results. The RAND misvalued codes to refine work RVUs effort, and stress due to risk) involved report is available under downloads on and direct PE inputs. We have assigned with furnishing a service and may the Web site for the CY 2015 PFS final appropriate work RVUs and direct PE include validation of the pre-, post-, and rule with comment period at http:// inputs for these services as a result of intra-service components of work. The www.cms.gov/Medicare/Medicare-Fee- these reviews. A more detailed Secretary is directed, as part of the for-Service-Payment/ discussion of the extensive prior validation, to validate a sampling of the PhysicianFeeSched/PFS-Federal- reviews of potentially misvalued codes work RVUs of codes identified through Regulation-Notices-Items/CMS-1612- is included in the CY 2012 PFS final any of the 16 categories of potentially FC.html. misvalued codes specified in section rule with comment period (76 FR 73052 After posting RAND’s report on the 1848(c)(2)(K)(ii) of the Act. through 73055). In the CY 2012 PFS models and results on our Web site, we Furthermore, the Secretary may conduct final rule with comment period, we received comments indicating that the finalized our policy to consolidate the the validation using methods similar to those used to review potentially models did not adequately address review of physician work and PE at the global surgery services due to the lack same time (76 FR 73055 through 73958), misvalued codes, including conducting of available data on included visits. and established a process for the annual surveys, other data collection activities, Therefore, we modified the RAND public nomination of potentially studies, or other analyses as the contract to include the development of misvalued services. Secretary determines to be appropriate In the CY 2013 PFS final rule with to facilitate the validation of RVUs of G-codes that could be used to collect comment period, we built upon the services. data about post-surgical follow-up visits work we began in CY 2009 to review In the CY 2011 PFS proposed rule (75 on Medicare claims to meet the potentially misvalued codes that have FR 40068) and CY 2012 PFS proposed requirements in section 1848(c)(8)(B) of not been reviewed since the rule (76 FR 42790), we solicited public the Act regarding collection of data on implementation of the PFS (so-called comments on possible approaches, global services. Our discussion related ‘‘Harvard-valued codes’’). In CY 2009, methodologies, and data sources that we to this data collection requirement is in we requested recommendations from should consider for a validation process. section II.D.6. Also, the data from this the RUC to aid in our review of Harvard- A summary of the comments along with project would provide information that valued codes that had not yet been our responses are included in the CY would allow the time for these services reviewed, focusing first on high-volume, 2011 PFS final rule with comment to be included in the model for low intensity codes (73 FR 38589). In period (75 FR 73217) and the CY 2012 validating RVUs.

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4. CY 2017 Identification and Review of beneficiary. We included a list of codes screen be limited to the codes that met Potentially Misvalued Services with total allowed services greater than the criteria and for which the overlap a. 0-Day Global Services That Are 20,000. There are 83 codes that met the had not already been considered by the Typically Billed With an Evaluation and proposed criteria for the screen and RUC in developing recommended Management (E/M) Service With were proposed as potentially misvalued. values. Several thousand commenters Modifier 25 We also sought comment regarding suggested withdrawing or limiting the additional ways to address appropriate scope of this screen, particularly as it Because routine E/M is included in valuations for all services that are pertains to the OMT codes. the valuation of codes with 0-, 10-, and typically billed with an E/M with Response: Section 1848(c)(2)(K) of the 90-day global periods, Medicare only Modifier 25. Act requires the Secretary to makes separate payment for E/M The following is the summary of the periodically identify potentially services that are provided in excess of comments we received. misvalued services and to review and those considered included in the global Comment: Several commenters make appropriate adjustments to the procedure. In such cases, the physician disagreed with CMS’ assertion that there relative values for those services. would report the additional E/M service is a possible valuation problem with the Section 1848(c)(2)(K) of the Act with Modifier 25, which is defined as a bundle when an E/M with Modifier 25 identifies several categories of services significant, separately identifiable E/M is typically reported on the same day of as potentially misvalued, including service performed by the same service as a 0-day global procedure. codes for services where there may be physician on the day of a procedure Commenters stated that billing an E/M efficiencies when a service is furnished above and beyond other services with Modifier 25 pays physicians for the at the same time as other services, along provided or beyond the usual preservice justifiable and appropriate services they with codes as determined appropriate and postservice care associated with the render to patients; allowing for a by the Secretary. Based on the procedure that was performed. Modifier patient-centered approach to care. Some comments received, we understand that 25 allows physicians to be paid for commenters considered the possibility stakeholders would have us identify as E/M services that would otherwise be that there could be fraudulent billing potentially misvalued only those denied as bundled. practices when reporting an E/M with individual codes with obvious In reviewing misvalued codes, both Modifier 25 and a few offered various overlapping resource costs when CMS and the RUC have often solutions for rectifying the problem typically reported with an E/M, rather considered how frequently particular from a program integrity perspective. than consider the issue of misvaluation codes are reported with E/M codes to For example, one commenter suggested of the global period more broadly. In account for potential overlap in that further education on the response to these comments, we are resources. Some stakeholders have appropriate use of Modifier 25 or finalizing the use of our screen for 0-day expressed concern with this policy penalty for misuse would be effective global services that are typically billed especially with regard to the valuation alternatives to combat inappropriate with an E/M with Modifier 25 as a of 0-day global services that are billing while another commenter mechanism for identifying services that typically billed with a separate E/M suggested investigating the diagnosis are potentially misvalued. service with the use of Modifier 25. For coding for services. Because we recognize that the example, when we established our Commenters overwhelmingly primary purpose in displaying lists of valuation of the osteopathic opposed any change to billing policies misvalued codes in rulemaking has been manipulative treatment (OMT) services, or standard valuation for 0-day services to seek recommendations regarding described by CPT codes 98925–98929, that are billed with an E/M with appropriate valuation from we did so with the understanding that Modifier 25. stakeholders, including the RUC, for these codes are usually reported with Response: We appreciate commenters’ 2017 we are only identifying the E/M codes. perspective on this issue. While we services for which we believe there For our CY 2017 proposal (81 FR understand the commenters’ views, might be the kind of misvaluation the 46187), we investigated Medicare claims since routine E/M is included in the RUC and the medical specialty societies data for CY 2015 and found that 19 valuation of 0-day global services we recognize. Based on the comments from percent of the codes that described 0- continue to believe that the routine these organizations, we believe that for day global services were billed over 50 billing of separate E/M services may still codes reviewed in the past 5 years, the percent of the time with an E/M with indicate a possible problem with the RUC has already addressed that kind of Modifier 25. Since routine E/M is valuation of the global period or the misvaluation. In other words, included in the valuation of 0-day assignment of the global period for commenters have made clear that global services, we believed that the particular codes, given that the period is external review of these services is routine billing of separate E/M services intended to include all the routine care likely to be limited to clear overlap in may have indicated a possible problem associated with the service. As resource costs, but will not address the with the valuation of the bundle, which discussed below, we are finalizing some broader concerns we have about is intended to include all the routine of the 0-day global services as developing rates for services that care associated with the service. potentially misvalued. We will also include routine E/M when evaluation In the proposed rule (81 FR 46187), continue to consider this issue for future and management is also routinely we stated that reviewing the procedure rulemaking. separately reported. As a result, we will codes typically billed with an E/M with Comment: Several commenters continue to consider that issue for Modifier 25 may be one avenue to expressed appreciation for the future rulemaking. We note that we are appropriate valuation for these services. identification of an objective screen and required under statute to improve the Therefore, we developed and proposed reasonable query. While some valuation of the 10- and 90-day global a screen for potentially misvalued codes commenters were accepting of the periods, and therefore, we will consider that identified 0-day global codes billed screen as proposed, others stated their this issue in that context, as well. with an E/M 50 percent of the time or preference for the screen to be Comment: While some commenters more, on the same day of service, with withdrawn entirely or limited in scope, supported our review of the 83 codes the same physician and same with some commenters suggesting the that were proposed as potentially

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misvalued through the screen, the screen because they were either commenters largely disagreed on the list majority of commenters, including the reviewed in the last 5 years and/or are of proposed codes, most agreed that the RUC, stated that the codes detailed in not typically reported with an E/M, and services they believed met the screen Table 7 did not meet the criteria for the therefore, should be removed. While criteria should be reviewed.

TABLE 7—CODES REQUESTED TO BE REMOVED FROM THE LIST OF POTENTIALLY MISVALUED SERVICES

HCPCS Long descriptor

11000 ...... Removal of inflamed or infected skin, up to 10% of body surface. 11100 ...... Biopsy of single growth of skin and/or tissue. 11300 ...... Shaving of 0.5 centimeters or less skin growth of the trunk, arms, or legs. 11301 ...... Shaving of 0.6 centimeters to 1.0 centimeters skin growth of the trunk, arms, or legs. 11302 ...... Shaving of 1.1 to 2.0 centimeters skin growth of the trunk, arms, or legs. 11305 ...... Shaving of 0.5 centimeters or less skin growth of scalp, neck, hands, feet, or genitals. 11306 ...... Shaving of 0.6 centimeters to 1.0 centimeters skin growth of scalp, neck, hands, feet, or genitals. 11307 ...... Shaving of 1.1 to 2.0 centimeters skin growth of scalp, neck, hands, feet, or genitals. 11310 ...... Shaving of 0.5 centimeters or less skin growth of face, ears, eyelids, nose, lips, or mouth. 11311 ...... Shaving of 0.6 centimeters to 1.0 centimeters skin growth of face, ears, eyelids, nose, lips, or mouth. 11312 ...... Shaving of 1.1 to 2.0 centimeters skin growth of face, ears, eyelids, nose, lips, or mouth. 11740 ...... Removal of blood accumulation between nail and nail bed. 11900 ...... Injection of up to 7 skin growths. 11901 ...... Injection of more than 7 skin growths. 12001 ...... Repair of wound (2.5 centimeters or less) of the scalp, neck, underarms, trunk, arms and/or legs. 12002 ...... Repair of wound (2.6 to 7.5 centimeters) of the scalp, neck, underarms, genitals, trunk, arms and/or legs. 12004 ...... Repair of wound (7.6 to 12.5 centimeters) of the scalp, neck, underarms, genitals, trunk, arms and/or legs. 12011 ...... Repair of wound (2.5 centimeters or less) of the face, ears, eyelids, nose, lips, and/or mucous membranes. 12013 ...... Repair of wound (2.6 to 5.0 centimeters) of the face, ears, eyelids, nose, lips, and/or mucous membranes. 17250 ...... Application of chemical agent to excessive wound tissue. 20550 ...... Injections of tendon sheath, ligament, or muscle membrane. 20552 ...... Injections of trigger points in 1 or 2 muscles. 20553 ...... Injections of trigger points in 3 or more muscles. 20600 ...... Aspiration and/or injection of small joint or joint capsule. 20604 ...... Arthrocentesis, aspiration and/or injection, small joint or bursa (eg, fingers, toes); with ultrasound guidance, with permanent recording and reporting. 20605 ...... Aspiration and/or injection of medium joint or joint capsule. 20606 ...... Arthrocentesis, aspiration and/or injection, intermediate joint or bursa (eg, temporomandibular, acromioclavicular, wrist, elbow or ankle, olecranon bursa); with ultrasound guidance, with permanent recording and reporting. 20610 ...... Aspiration and/or injection of large joint or joint capsule. 20611 ...... Arthrocentesis, aspiration and/or injection, major joint or bursa (eg, shoulder, hip, knee, subacromial bursa); with ultrasound guidance, with permanent recording and reporting. 20612 ...... Aspiration and/or injection of cysts. 29125 ...... Application of non-moveable, short arm splint (forearm to hand). 29515 ...... Application of short leg splint (calf to foot). 30901 ...... Simple control of nose bleed. 30903 ...... Complex control of nose bleed. 31231 ...... Diagnostic examination of nasal passages using an endoscope. 31238 ...... Control of nasal bleeding using an endoscope. 31500 ...... Emergent insertion of breathing tube into windpipe cartilage using an endoscope. 31575 ...... Diagnostic examination of voice box using flexible endoscope. 31579 ...... Examination to assess movement of vocal cord flaps using an endoscope. 31645 ...... Aspiration of lung secretions from lung airways using an endoscope. 32551 ...... Removal of fluid from between lung and chest cavity, open procedure. 32554 ...... Removal of fluid from chest cavity. 40490 ...... Biopsy of lip. 46600 ...... Diagnostic examination of the anus using an endoscope. 51701 ...... Insertion of temporary bladder catheter. 51702 ...... Insertion of indwelling bladder catheter. 51703 ...... Insertion of indwelling bladder catheter. 56605 ...... Biopsy of external female genitals. 57150 ...... Irrigation of vagina and/or application of drug to treat infection. 57160 ...... Fitting and insertion of vaginal support device. 58100 ...... Biopsy of uterine lining. 64418 ...... Injection of anesthetic agent, collar bone nerve. 65222 ...... Removal of foreign body, external eye, cornea with slit lamp examination. 67810 ...... Biopsy of eyelid. 67820 ...... Removal of eyelashes by forceps. 68200 ...... Injection into conjunctiva. 69100 ...... Biopsy of ear. 69200 ...... Removal of foreign body from ear canal. 69210 ...... Removal of impact ear wax, one ear. 69220 ...... Removal of skin debris and drainage of mastoid cavity. 92511 ...... Examination of the nose and throat using an endoscope. 92941 ...... Insertion of stent, removal of plaque and/or balloon dilation of coronary vessel during heart attack, accessed through the skin. 92950 ...... Attempt to restart heart and lungs.

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TABLE 7—CODES REQUESTED TO BE REMOVED FROM THE LIST OF POTENTIALLY MISVALUED SERVICES—Continued

HCPCS Long descriptor

98925 ...... Osteopathic manipulative treatment to 1–2 body regions. 98926 ...... Osteopathic manipulative treatment to 3–4 body regions. 98927 ...... Osteopathic manipulative treatment to 5–6 body regions. 98928 ...... Osteopathic manipulative treatment to 7–8 body regions. 98929 ...... Osteopathic manipulative treatment to 9–10 body regions.

Response: After considering the we did not intend to apply it in this not believe that we should include comments received, we are significantly case, given our concerns with the codes reviewed in the past 5 years on reducing the number of codes identified valuation of the global period when E/ this list of misvalued codes, given the as potentially misvalued. We agree with M visits are routinely reported at the limited nature of the likely review. commenters that the majority of the same time. As displayed in the Regarding the accuracy of which of the codes that we are not finalizing have proposed rule, the list of codes reflected codes are typically reported with E/M been recently reviewed. Due to a our intention to include codes that have codes, we note that our review included drafting error in the proposed rule, we been recently reviewed. Regardless, we analysis was based on more recent, full stated that we had exempted codes that understand based on comments that any claims data than had yet been made had been reviewed in the past 5 years. review by stakeholders for recently public. In the interest of transparency, While that exclusion has been standard reviewed codes would be likely to result we are finalizing the list of services for many other misvalued code screens, in similar valuation. Therefore, we do based on the publically available data.

TABLE 8—LIST OF POTENTIALLY MISVALUED SERVICES IDENTIFIED THROUGH THE SCREEN FOR 0-DAY GLOBAL SERVICES THAT ARE TYPICALLY BILLED WITH AN EVALUATION AND MANAGEMENT (E/M) SERVICE WITH MODIFIER 25

HCPCS Long descriptor

11755 ...... Biopsy of finger or toe nail. 20526 ...... Injection of carpal tunnel. 20551 ...... Injections of tendon attachment to bone. 20612 ...... Aspiration and/or injection of cysts. 29105 ...... Application of long arm splint (shoulder to hand). 29540 ...... Strapping of ankle and/or foot. 29550 ...... Strapping of toes. 43760 ...... Change of stomach feeding, accessed through the skin. 45300 ...... Diagnostic examination of rectum and large bowel using an endoscope. 57150 ...... Irrigation of vagina and/or application of drug to treat infection. 57160 ...... Fitting and insertion of vaginal support device. 58100 ...... Biopsy of uterine lining. 64405 ...... Injection of anesthetic agent, greater occipital nerve. 64455 ...... Injections of anesthetic and/or steroid drug into nerve of foot. 65205 ...... Removal of foreign body in external eye, conjunctiva. 65210 ...... Removal of foreign body in external eye, conjunctiva or sclera. 67515 ...... Injection of medication or substance into membrane covering eyeball. G0168 ...... Wound closure utilizing tissue adhesive(s) only. G0268 ...... Removal of impacted cerumen (one or both ears) by physician on same date of service as audiologic function testing.

b. End-Stage Renal Disease Home Under the MCP methodology, to receive dialysis with less than a full month of Dialysis Services (CPT Codes 90963 the highest payment, a physician would services. Through 90970) have to provide at least four ESRD- In a GAO report titled ‘‘END-STAGE related visits per month. However, In the CY 2004 PFS final rule with RENAL DISEASE Medicare Payment payment for home dialysis MCP services comment period (68 FR 63216), we Refinements Could Promote Increased only varied by the age of beneficiary. established new Level II HCPCS G-codes Use of Home Dialysis’’ dated October for end-stage renal disease (ESRD) Although we did not initially specify a 2015, http://www.gao.gov/products/ services and established payment for frequency of required visits for home GAO-16-125, the GAO stated that those codes through monthly capitation dialysis MCP services, we stated that we experts and stakeholders they payment (MCP) rates. For ESRD center- expect physicians to provide clinically interviewed indicated that home based patients, payment for the G-codes appropriate care to manage the home dialysis could be clinically appropriate varied based on the age of the dialysis patient. for at least half of patients. Also, at a beneficiary and the number of face-to- The CPT Editorial Panel created new meeting in 2013, the chief medical face visits furnished each month (for CPT codes to replace the G-codes for officers of 14 dialysis facility chains example, 1 visit, 2–3 visits and 4 or monthly ESRD-related services, and we jointly estimated that a realistic target more visits). We believed that many accepted the new codes for use under for home dialysis would be 25 percent physicians would provide 4 or more the PFS in CY 2009. The CPT codes of dialysis patients. The GAO noted that visits to center-based ESRD patients and created were 90963–90966 for monthly CMS data showed that about 10 percent a small proportion will provide 2–3 ESRD-related services for home dialysis of adult Medicare dialysis patients use visits or only one visit per month. patient and CPT codes 90967–90970 for home dialysis as of March 2015.

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In the report, the GAO noted that among patients for whom it is believed that this unusual degree of CMS intended for the existing payment appropriate. Therefore, we proposed to variation was likely to result in code structure to create an incentive for identify CPT codes 90963 through misvaluation. To facilitate efficient physicians to prescribe home dialysis, 90970 as potentially misvalued codes review of this particular kind of because the monthly payment rate for based on the volume of claims misvaluation, and because we believed managing the dialysis care of home submitted for these services relative to that stakeholders would prefer the patients, which requires a single in- those submitted for facility ESRD opportunity to contribute to such person visit, was approximately equal to services. standardization, we requested that the rate for managing and providing two The following is summary of the stakeholders like the AMA RUC review to three visits to ESRD center-based comments we received. and make recommendations on the patients. However, GAO found that, in Comment: Commenters supported the appropriate endoscopic equipment and 2013, the rate of $237 for managing proposal to identify these codes as supplies typically provided in all home patients was lower than the potentially misvalued and supported endoscopic procedures for each average payment of $266 and maximum CMS’ goal of encouraging the use of anatomical body region, along with their payment of $282 for managing ESRD home dialysis among patients for whom appropriate prices. center-based patients. The GAO stated it is appropriate. Some commenters The following is summary of the that this difference in payment rates suggested we establish parity between comments we received. may discourage physicians from payment for four ESRD-related visits per Comment: Many commenters stated prescribing home dialysis. month for in-center dialysis patients that the RUC is the appropriate resource Physician associations and other and payment for the care of home for the review of appropriate direct PE physicians GAO interviewed stated that dialysis patients for an entire month. inputs involved in procedures involving the visits with home patients are often One commenter cautioned that CMS endoscopes and urged CMS to work longer and more comprehensive than in- should also consider factors other than with the RUC to address this issue. center visits; this is in part because payment that play a critical role in Additionally, the RUC stated that due to physicians may conduct visits with whether a patient decides to use a home the complexity of this issue and the individual home patients in a private dialysis modality as outlined in a recent need to incorporate input from various setting, but they may be able to more GAO report and requested that CMS specialty societies that the RUC planned easily visit multiple in-center patients work closely with nephrologists on this to form a workgroup of the PE on a single day as they receive dialysis. issue. One commenter encouraged CMS subcommittee to review the issue. The physician associations GAO to focus on incentives for the adult Response: We appreciate the interviewed also said that they may population separately from pediatrics as comments and will review any spend a similar amount of time outside they see no benefit from reanalysis of recommendation provided to us by the of visits to manage the care of home the pediatric home and daily dialysis RUC for use in future rulemaking, patients and that they are required to CPT codes 90963–90965 and 90967– consistent with our normal review provide at least one visit per month to 90969. processes. perform a complete assessment of the Response: We appreciate all of the ii. Appropriate Direct PE Inputs in the patient. comments and agree that CPT codes Facility Post-Service Period When Post- It is important to note that, as stated 90963 through 90970 should be in the CY 2011 PFS final rule with Operative Visits Are Excluded identified as potentially misvalued. In the proposed rule (81 FR 46190), comment period (75 FR 73296), we After considering the comments, we are believe that furnishing monthly face-to- we identified a potential inconsistency finalizing the addition of CPT codes face visits is an important component of in instances where there are direct PE 90963 through 90970 to the list of high quality medical care for ESRD inputs included in the facility potentially misvalued codes. We will patients being dialyzed at home and postservice period even though post- also continue to consider these issues generally would be consistent with the operative visit is not included in a for future rulemaking. current standards of medical practice. service. We identified 13 codes affected However, we also acknowledged that c. Direct PE Input Discrepancies by this issue and stated that we were unclear if the discrepancy was caused extenuating circumstances may arise i. Appropriate Direct PE Inputs Involved by inaccurate direct PE inputs or that make it difficult for the MCP in Procedures Involving Endoscopes physician (or NPP) to furnish a visit to inaccurate post-operative data in the a home dialysis patient every month. In the proposed rule (81 FR 46190), work time file. We requested that Therefore, we allow Medicare we stated that stakeholders had raised stakeholders including the AMA RUC contractors the discretion to waive the concerns about potential inconsistencies review these discrepancies and provide requirement for a monthly face-to-face with the inputs and the prices related to their recommendations on the visit for the home dialysis MCP service endoscopic procedures in the direct PE appropriate direct PE inputs for the on a case-by-case basis, for example, database. Upon review, we noted that codes. when the MCP physician’s (or NPP’s) there are 45 different pieces of The following is summary of the notes indicate that the MCP physician endoscope related-equipment and 25 comments we received. (or NPP) actively and adequately different pieces of endoscope related- Comment: The RUC stated that for managed the care of the home dialysis supplies that are currently associated CPT codes 21077 (Impression and patient throughout the month. with these services. Relative to other preparation of eye socket prosthesis), The GAO recommended, and we kinds of equipment items in the direct 21079 (Impression and custom agreed, that CMS examine Medicare PE input, these items are much more preparation of temporary oral policies for monthly payments to varied and used for many fewer prosthesis), 21080 (Impression and physicians to manage the care of services. Given the frequency with custom preparation of permanent oral dialysis patients and revise them if which individual codes can be reviewed prosthesis), 21081 (Impression and necessary to ensure that these policies and the importance of standardizing custom preparation of lower jaw bone are consistent with our goal of inputs for purposes of maintaining prosthesis), 21082 (Impression and encouraging the use of home dialysis relativity across PFS services, we custom preparation of prosthesis for

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roof of mouth enlargement), 21083 appropriately accounted for variations on approaches to the appropriate (Impression and custom preparation of in the service relative to which devices valuation of these services. roof of mouth prosthesis), and 21084 and related drugs are inserted and In the CY 2016 PFS proposed rule (80 (Impression and custom preparation of removed. FR 41707), we again solicited public speech aid prosthesis) the practice The following is summary of the comment and recommendations on expense time in the postservice period comments we received. approaches to address the appropriate in the facility setting is completely Comment: One commenter stated that valuation of moderate sedation related distinct from the physician post- CMS should create distinct codes and to Appendix G services. Following our operative visit and that time must be payment levels for a four-rod implant as comment solicitation, the CPT Editorial accounted for the manufacture and opposed to the one-rod implant detailed Panel created CPT codes for separately fitting of the prosthetics. The RUC in CPT codes 11981–11983. In contrast, reporting moderate sedation services in stated that the following codes all had another commenter stated that the association with the elimination of inaccurate post-operative data in the identified codes adequately describe the Appendix G from the CPT manual for work time file and provided work and practice expense for drug CY 2017. This coding change would recommendations on appropriate post- implant delivery and removal services. provide for payment for moderate operative visits: CPT codes 28636 Additionally, another commenter stated sedation services only in cases where (Insertion of hardware to foot bone the codes should be removed from the they are furnished. In addition to dislocation with manipulation, accessed potentially misvalued list. The RUC providing recommended values for the through the skin), 28666 (Insertion of stated that a coding change proposal new codes used to separately report hardware to toe joint dislocation with had been submitted for the services moderate sedation, the RUC provided a manipulation, accessed through the under the CPT process and that the RUC methodology for revaluing all services skin), 43652 (Incision of vagus nerves of anticipated providing relevant previously identified in Appendix G, without moderate sedation, in order to stomach using an endoscope), 47570 recommendations for CY 2018. (Connection of gall bladder to bowel make appropriate corresponding Response: We thank stakeholders for using an endoscope), and 66986 adjustments for the procedural services. their comments. We will review new (Exchange of lens prosthesis). The RUC recommended this coding and recommended valuations for Additionally, another commenter stated methodology to address moderate future rulemaking, consistent with our that CPT code 46900 (Chemical sedation valuation generally instead of normal review processes. destruction of anal growths) also had recommending that it be addressed as inaccurate post-operative data in the 5. Valuing Services That Include individual codes are reviewed. The work time file and provided a Moderate Sedation as an Inherent Part RUC’s recommended methodology recommendation on the appropriate of Furnishing the Procedure would remove work RVUs for moderate post-operative visit. sedation from Appendix G codes based Response: We thank stakeholders for The CPT manual identifies more than on a code-level assessment of whether their comments. We will review the 400 diagnostic and therapeutic the procedures are typically furnished recommendations provided to us by the procedures (listed in Appendix G) for to straightforward patients or more AMA RUC and other commenters and which the CPT Editorial Panel has difficult patients. Based on its will consider for future rulemaking, determined that moderate sedation is an recommended methodology, the RUC consistent with our normal review inherent part of furnishing the recommended removal of fewer RVUs processes. procedure. In developing RVUs for these from each of the procedural services services, we include the relative than it recommended for valuing the d. Insertion and Removal of Drug resources associated with moderate moderate sedation services. If we were Delivery Implants—CPT Codes 11981 sedation in the valuation since the CPT to use the RUC-recommended values for and 11983 codes include moderate sedation as an both the moderate sedation codes and In the proposed rule (81 FR 46190), inherent part of the procedure. the Appendix G procedural codes we stated that stakeholders had urged Therefore, practitioners only report the without refinement, overall payments CMS to create new coding describing procedure code when furnishing the for these procedures, when moderate the insertion and removal of drug service. Endoscopic procedures sedation is furnished, would increase delivery implants for buprenorphine constitute a significant portion of the relative to the current payment. hydrochloride, formulated as a 4 rod, 80 services identified in Appendix G. In We direct readers to section II.L. of mg, long acting subdermal drug implant the CY 2015 PFS proposed rule (79 FR this final rule, which includes more for the treatment of opioid addiction. 40349), we noted that it appeared that detail regarding our valuation of the The stakeholders suggested that current practice patterns for endoscopic new moderate sedation codes, our coding describing insertion and removal procedures were changing, with methodology for revaluation of the of drug delivery implants was too broad anesthesia increasingly being separately procedural codes previously identified and that new coding was needed to reported for these procedures, meaning in Appendix G, and discussion and account for specific additional resource that the relative resources associated responses to the public comments we costs associated with particular with sedation were no longer incurred received regarding our proposal. We treatment. We identified existing CPT by the practitioner reporting the believe that the RVUs assigned under codes 11981 (Insertion, non- Appendix G procedure. We indicated the PFS should reflect the overall biodegradable drug delivery implant), that, in order to reflect apparent changes relative resources of PFS services, 11982 (Removal, non-biodegradable in medical practice, we were regardless of how many codes are used drug delivery implant), and 11983 considering establishing a uniform to report the services. Therefore, our (Removal with reinsertion, non- approach to the appropriate valuation of methodology for valuation of Appendix biodegradable drug delivery implant) as all Appendix G services for which G procedural services maintains current potentially misvalued codes and sought moderate sedation is no longer inherent, resource assumptions for the procedures comment and information regarding rather than addressing the issue at the when furnished with moderate sedation whether the current resource inputs in procedure level as individual codes are and redistributes the RVUs associated work and practice expense for the codes revalued. We solicited public comment with moderate sedation (previously

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included in the Appendix G procedural the day of the service. The 10-day global codes in CY 2017 and CY 2018, codes) to other PFS services. We believe packages include these services and, in respectively, to improve the accuracy of that this methodology for revaluation of addition, visits related to the procedure valuation and payment for the various Appendix G services without moderate during the 10 days following the day of components of global packages, sedation is consistent with our general the procedure. The 90-day global including pre- and post-operative visits principle that the overall relative packages include the same services as and the procedure itself, we stated that resources for the procedures do not the 0-day global codes plus the pre- we were adopting this policy because it change based solely on changes in operative services furnished one day is critical that PFS payment rates be coding. prior to the procedure and post- based upon RVUs that reflect the We also noted in the CY 2017 PFS operative services during the 90 days relative resources involved in furnishing proposed rule that stakeholders immediately following the day of the the services. We also stated our belief presented information to CMS regarding procedure. Section 40.1 of Chapter 12 of that transforming all 10- and 90-day specialty group survey data for the Claims Processing Manual (Pub. global codes to 0-day global packages physician work. The stakeholders 100–04) defines the global surgical would: shared survey results for physician work package to include the following • Increase the accuracy of PFS involved in furnishing moderate services related to the surgery when payment by setting payment rates for sedation that demonstrated a significant furnished during the global period by individual services that more closely bimodal distribution between the same physician or another reflect the typical resources used in procedural services furnished by practitioner in the same group practice: furnishing the procedures; gastroenterologists (GI) and procedural • Pre-operative Visits: Pre-operative • Avoid potentially duplicative or services furnished by other specialties. visits after the decision is made to unwarranted payments when a Since we believe that gastroenterologists operate beginning with the day before beneficiary receives post-operative care furnish the highest volume of services the day of surgery for major procedures from a different practitioner during the previously identified in Appendix G, and the day of surgery for minor global period; and services primarily furnished by procedures; • Eliminate disparities between the gastroenterologists prompted the • Intra-operative Services: Intra- payment for E/M services in global concerns that led to our identification of operative services that are normally a periods and those furnished changes in medical practice and usual and necessary part of a surgical individually; potentially duplicative payment for procedure; • Maintain the same-day packaging of these codes, we have addressed the • Complications Following Surgery: pre- and post-operative physicians’ variations between GI and other All additional medical or surgical services in the 0-day global packages; specialties in our review of the new services required of the surgeon during and moderate sedation CPT codes and their the post-operative period of the surgery • Facilitate the availability of more recommended values. We again direct because of complications that do not accurate data for new payment models readers to section II.L. of this final rule require additional trips to the operating and quality research. where we discuss our establishment of room; (2) Data Collection & Revaluation of • Post-operative Visits: Follow-up an endoscopy-specific moderate Global Packages Required by MACRA sedation G-code that augments the new visits during the post-operative period CPT codes for moderate sedation, the of the surgery that are related to Section 523(a) of the Medicare Access public comments we received, and our recovery from the surgery; and CHIP Reauthorization Act of 2015 • finalized valuations reflecting the Post-surgical Pain Management: By (MACRA) (Pub. L. 114–10, enacted the surgeon; and April 16, 2015) added section differences in the physician survey data • between GI and other specialties. Miscellaneous Services: Items such 1848(c)(8)(A) of the Act, which as dressing changes; local incisional prohibits the Secretary from 6. Collecting Data on Resources Used in care; removal of operative pack; removal implementing the policy, described Furnishing Global Services of cutaneous sutures and staples, lines, above, that would have transformed all a. Background wires, tubes, drains, casts, and splints; 10-day and 90-day global surgery insertion, irrigation and removal of packages to 0-day global packages. (1) Current Payment Policy for Global urinary catheters, routine peripheral Section 1848(c)(8)(B) of the Act, Packages intravenous lines, nasogastric and rectal which was also added by section 523(a) Under the PFS, certain services, such tubes; and changes and removal of of the MACRA, requires us to collect as surgery, are valued and paid for as tracheostomy tubes. data to value surgical services. Section part of global packages that include the In the CY 2015 PFS proposed and 1848(c)(8)(B)(i) of the Act requires us to procedure and the services typically final rules we extensively discussed the develop, through rulemaking, a process furnished in the periods immediately problems with accurate valuation of 10- to gather information needed to value before and after the procedure. For each and 90-day global packages. Our surgical services from a representative of these global packages, we establish a concerns included the fact that we do sample of physicians, and requires that single PFS payment that includes not use actual data on services the data collection begin no later than payment for particular services that we furnished to update the rates, questions January 1, 2017. The collected assume to be typically furnished during regarding the accuracy of our current information must include the number the established global period. There are assumptions about typical services, and level of medical visits furnished three primary categories of global whether we will be able to adjust values during the global period and other items packages that are labeled based on the on a regular basis to reflect changes in and services related to the surgery and number of post-operative days included the practice of medicine and health care furnished during the global period, as in the global period: 0-day; 10-day; and delivery, and how our global payment appropriate. This information must be 90-day. The 0-day global packages policies affect what services are actually reported on claims at the end of the include the surgical procedure and the furnished (79 FR 67582 through 67585). global period or in another manner pre-operative and post-operative In finalizing a policy to transform all 10- specified by the Secretary. Section services furnished by the physician on and 90-day global codes to 0-day global 1848(c)(8)(B)(ii) of the Act requires that,

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every 4 years, we reassess the value of the CY 2016 proposed rule regarding not have the same level of information this collected information; and allows potential methods of valuing the about the components of global us to discontinue the collection of this individual components of the global packages as we do for other services. To information if the Secretary determines surgical package. A large number of value global packages accurately and that we have adequate information from comments expressed strong support for relative to other procedures, we need other sources to accurately value global our proposal to hold an open door accurate information about the surgical services. Section forum or town hall meetings with the resources—work, PEs and malpractice— 1848(c)(8)(B)(iii) of the Act specifies public. In response, we held a national used in furnishing the procedure, that the Inspector General shall audit a listening session on January 20, 2016. similar to what is used to determine sample of the collected information to Prior to the listening session, the topics RVUs for all services. In addition we verify its accuracy. Section 1848(c)(9) of for which guidance was being sought need the same information on the post- the Act (added by section 523(b) of the were sent electronically to those who operative services furnished in the MACRA) authorizes the Secretary, registered for the session and made global period (and pre-operative through rulemaking, to delay up to 5 available on our Web site. The topics services the day before for 90-day global percent of the PFS payment for services were: packages). Public comments about our for which a physician is required to • Capturing the types of services CY 2015 proposal to value all global report information under section typically furnished during the global services as 0-day global services and pay 1848(c)(8)(B)(i) of the Act until the period. separately for additional post-operative required information is reported. • Determining the representative services when furnished indicated that Section 1848(c)(8)(C) of the Act, sample for the claims-based data there were no reliable data available on which was also added by section 523(a) collection. the value of the underlying procedure of the MACRA, requires that, beginning • Determining whether we should that did not also incorporate the value in CY 2019, we must use the collect data on all surgical services or, of the post-operative services, information collected as appropriate, if not, which services should be reinforcing our view that more data are along with other available data, to sampled. needed across the board. improve the accuracy of valuation of • Potential for designing data While we believe that most of the surgical services under the PFS. collection elements to interface with services furnished in the global period existing infrastructure used to track are visits for follow-up care, we do not (3) Public Input follow-up visits within the global have accurate information on the As noted above, section 1848(c)(8)(C) period. number and level of visits typically of the Act mandates that we use the • Consideration of using the 5 percent furnished because those billing for collected data to improve the accuracy withhold until required information is global services are not required to of valuation of surgery services furnished to encourage reporting. submit claims for post-operative visits. beginning in 2019. We described in the The 658 participants in the national A May 2012 Office of Inspector General CY 2015 PFS final rule (79 FR 67582 listening session provided valuable (OIG) report, titled Cardiovascular through 67591) the limitations and information on this task. A written Global Surgery Fees Often Did Not difficulties involved in the appropriate transcript and an audio recording of this Reflect the Number of Evaluation and valuation of the global packages, session are available at https:// Management Services Provided (http:// especially when the resources and the www.cms.gov/Outreach-and-Education/ oig.hhs.gov/oas/reports/region5/ related values assigned to the Outreach/NPC/National-Provider-Calls- 50900054.pdf) found that for 202 of the component services are not defined. To and-Events-Items/2016-01-20- 300 sampled cardiovascular global gain input from stakeholders on MACRA.html. surgeries, the Medicare payment rates implementation of this data collection, were based on a number of visits that b. Data Collection Required To we sought comment on various aspects did not reflect the actual number of Accurately Value Global Packages of this task in the CY 2016 proposed services provided. Specifically, rule (80 FR 41707 through 41708). We Resource-based valuation of physicians provided fewer services than solicited comments from the public individual physicians’ services is a the visits included in the payment regarding the kinds of auditable, critical foundation for Medicare calculation for 132 global surgery objective data (including the number payment to physicians. It is essential services and provided more services and type of visits and other services that the RVUs under the PFS be based than were included in the payment furnished during the post-operative as closely and accurately as possible on calculations for 70 services. Similar period by the practitioner furnishing the the actual resources used in furnishing results were found in OIG reports titled procedure) needed to increase the specific services to make appropriate ‘‘Musculoskeletal Global Surgery Fees accuracy of the valuation and payment payment and preserve relativity among Often Did Not Reflect The Number Of for 10- and 90-day global packages. We services. For global surgical packages, Evaluation And Management Services also solicited comment on the most this requires using objective data on all Provided’’ (http://oig.hhs.gov/oas/ efficient means of acquiring these data of the resources used to furnish the reports/region5/50900053.asp) and as accurately and efficiently as possible. services that are included in the ‘‘Review of Cataract Global Surgeries For example, we sought information on package. Not having such data for some and Related Evaluation and the extent to which individual components may significantly skew Management Services, Wisconsin practitioners or practices may currently relativity and create unwarranted Physicians Service Insurance maintain their own data on services payment disparities within the PFS. Corporation Calendar Year 2003, March furnished during the post-operative The current valuations for many 2007.’’ (http://oig.hhs.gov/oas/reports/ period, and how we might collect and services valued as global packages are region5/50600040.pdf). objectively analyze those data and use based upon the total package as a unit Claims data plays a major role in PFS the results for increasing the accuracy of rather than by determining the resources ratesetting. Specifically, Medicare the values beginning in CY 2019. used in furnishing the procedure and claims data are a primary driver in the We received many comments in each additional service/visit and allocation of indirect PE RVUs and MP response to the comment solicitation in summing the results. As a result, we do RVUs across the codes used by

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particular specialties, and in making sections 1848(c)(2)(M) and (c)(8)(B)(i) of halls is available on the CMS Web site overall budget neutrality and relativity the Act, we proposed to gather the data with the CY 2017 final rule downloads. adjustments. In most cases, a claim must needed to determine how to best (1) Statutory Authority for Data be filed for all visits. Such claims structure global packages with post- Collection provide information such as the place of operative care that is typically delivered service, the type and, if relevant, the days, weeks or months after the As described in this section of the level of the service, the date of the procedure and whether there are some final rule, section 1848(c)(8)(B)(i) of the service, and the specialty of the procedures for which accurate valuation Act requires us to develop, through practitioner furnishing the services. for packaged post-operative care is not rulemaking, a process to gather Because we have not required claims possible. Finally, we indicated that information needed to value surgical reporting of visits included in global these data would provide useful services from a representative sample of surgical packages, we do not have any information to assess the resources used physicians. The statute requires that the of this information for the services in furnishing pre- and post-operative collected information include the bundled in the package. care in global periods. To accurately do number and level of medical visits In addition to the lack of information so, we need to know the volume and furnished during the global period and about the number and level of visits costs of the resources typically used. other items and services related to the actually furnished, the current global We proposed a three-pronged surgery and furnished during the global valuations rely on crosswalks to E/M approach to collect timely and accurate period, as appropriate. visits, based upon the assumption that data on the frequency of and the level In addition, section 1848(c)(2)(M) of the resources, including work, used in of pre- and post-operative visits and the the Act, which was added to the Act by furnishing pre- and post-operative visits resources involved in furnishing the section 220 of the PAMA, authorizes the are similar to those used in furnishing pre-operative visits, post-operative Secretary to collect or obtain E/M visits. We are unaware of any visits, and other services for which information on resources directly or studies or surveys that verify this payment is included in the global indirectly related to furnishing services assertion. Although we generally value surgical payment. By analyzing these for which payment is made under the the visits included in global packages data, we would not only have the most PFS. Such information may be collected using the same direct PE inputs as are comprehensive information available on or obtained from any eligible used for E/M visits, for services for the resources used in furnishing these professional or any other source. which the RUC recommendations services, but also would be able to Information may be collected or include specific PE inputs in addition to determine the appropriate packages for obtained from surveys of physicians, those typically included for E/M visits, such services. Specifically, the proposal other suppliers, providers of services, we generally use the additional inputs included: manufacturers, and vendors. That in the global package valuation. In • A requirement for claims-based section also authorizes the Secretary to contrast, when a visit included in a reporting about the number and level of collect information through any other global package would use fewer pre- and post-operative visits furnished mechanism determined appropriate. resources than a comparable E/M for 10- and 90-day global services. When using information gathered under service, the RUC generally does not • A survey of a representative sample this authority, the statute requires the include recommendations to decrease of practitioners about the activities Secretary to disclose the information the PE inputs of the visit included in the involved in and the resources used in source and discuss the use of such global package, and we have not providing a number of pre- and post- information in the determination of generally made comparable reductions. operative visits during a specified, relative values through notice and Another inconsistency with our current recent period of time, such as two comment rulemaking. global package valuation approach is weeks. As described in this section of the that even though we effectively assume • A more in-depth study, including final rule, to gain information to assist that the E/M codes are appropriate for direct observation of the pre- and post- CMS in determining the appropriate valuing pre- and post-operative services, operative care delivered in a small packages for global services and to the indirect PE inputs used for number of sites, and a separate survey revalue those services, CMS needs more calculating payments for global services module for practitioners practicing in information on the resources used in are based upon the specialty mix ACOs. furnishing such services. Through the furnishing the global service, not the The information collected and claims-based data collection and the specialty mix of the physicians analyzed through the activities would study we are finalizing in this final rule, furnishing the E/M services, resulting in be the first comprehensive look at the we would have better information about a different valuation for the E/M volume and level of services in a global the actual number of services furnished services contained in global packages period, and the activities and inputs to Medicare beneficiaries to use in than for separately billable E/M involved in furnishing global services. valuation for these codes than has been services. There is a critical need to The data from these activities would typically available, such as from RUC obtain complete information if we are to ultimately inform our revaluation of surveys that reflect practitioner’s value global packages accurately and in global surgical packages as required by estimates of the number of services a way that preserves relativity across the statute. typically furnished. We anticipate that fee schedule. To expand awareness of the proposal such efforts would inform how to more In response to the requirement of for data collection, we held a national regularly collect data on the resources section 1848(c)(8)(B)(i) of the Act that listening session in which CMS used in furnishing physicians’ services. we develop, through rulemaking, a reviewed the proposal for participants. To the extent that such mechanisms process to gather information needed to Subsequent to this national listening prove valuable, they may be used to value surgical services, we proposed a session, we held a town hall meeting at collect data for valuing other services. rigorous data collection effort to provide the CMS headquarters in which To achieve this significant data us the data needed to accurately value participants, in person and virtual, collection, we proposed to collect data the 4,200 codes with a 10- or 90-day shared their views on the proposal with under the authority of both section global period. Using our authority under CMS. The transcript from these town 1848(c)(8)(B) and (c)(2)(M) of the Act.

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(2) Claims-Based Data Collection solicitation in the CY 2016 PFS available data on visits included in the We proposed a claims-based data proposed rule and the input received global package. Therefore, we modified collection that would have required all via the January 2016 listening session, the validation contract to include the those providing 10- or 90-day global we received numerous development of G-codes that could be services to report on services furnished recommendations for the information to used to collect data about post-surgical during the global period using a series be reported on claims. The most follow-up visits on Medicare claims for of G-codes specially created for this frequently recommended approach was valuing global services under MACRA for practitioners to report the existing so that this time could be included in purpose, beginning January 1, 2017. CPT code for follow-up visits included the model for validating RVUs. In response to the comments in the surgical package (CPT 99024— To inform its work on developing submitted on the proposal, we are Postoperative follow-up visit, normally coding for claims-based reporting, the finalizing a claims-based data collection included in the surgical package, to contractor conducted interviews with that differs from this proposal in the indicate that an E/M service was surgeons and other physicians/non- following significant ways: performed during a postoperative period physician practitioners (NPP) who • CPT code 99024 will be used for for a reason(s) related to the original provide post-operative care. A technical reporting post-operative services rather procedure). Others suggested using this expert panel (TEP), convened by the than the proposed set of G-codes. code for outpatient visits and using contractor, reviewed the findings of the Reporting will not be required for pre- length of stay data to estimate the interviews and provided input on how operative visits included in the global number of inpatient visits during the to best capture care provided in the package or for services not related to global period. In response to our post-operative period on claims. patient visit. In summarizing the input from the • concerns that CPT code 99024 would Reporting will be required only for provide only the number of visits and interviews and the TEP, the contractor services related to codes reported not the level of visits as required by the indicated that several considerations annually by more than 100 practitioners statute, one commenter suggested using were important in developing a claims- and that are reported more than 10,000 modifiers in conjunction with CPT code based method for capturing post- times or have allowed charges in excess 99024 to indicate the level of the visit operative services. First, a simple of $10 million annually. system to facilitate reporting was • furnished. Others recommended using Practitioners are encouraged to existing CPT codes for E/M visits to needed. Since it was reported that a begin reporting post-operative visits for report post-operative care. One majority of post-operative visits are procedures furnished on or after January commenter suggested that CMS analyze straightforward, the contractor found 1, 2017, but the mandatory requirement data from a sample of large systems and that a key for any proposed system is to report will be effective for services practices that are using electronic health identifying the smaller number of related to global procedures furnished records that require entry of some CPT complex post-operative visits. Another on or after July 1, 2017. consideration was not using the existing • code for every visit to capture the Only practitioners who practice in number of post-operative visits. After CPT E/M structure to capture groups with 10 or more practitioners in noting that the documentation postoperative care because of concerns Florida, Kentucky, Louisiana, Nevada, requirements and PEs required for post- that E/M codes are inadequately New Jersey, North Dakota, Ohio, operative visits differ from those of E/ designed to capture the full scope of Oregon, and Rhode Island will be M visits outside the global period, one post-operative care and that using such required to report. Practitioners who commenter encouraged us to develop a codes might create confusion. Another only practice in smaller practices or in separate series of codes to capture the consideration was that the TEP was other geographic areas are encouraged to work of the post-operative services and most enthusiastic about a set of codes report data, if feasible. to measure, not just estimate, the that used site of care, time, and Given that the data collection will be number and complexity of visits during complexity to report visits. The limited to only some states, a subset of the global period. contractor also believed it was global services, and only to those who Other commenters opposed the use of important to distinguish—particularly practice in larger practices the a new set of codes or the use of in the inpatient setting—between information collected through claims for modifiers to report post-operative visits. circumstances where a surgeon is global packages services will not Commenters also noted several issues providing primary versus secondary parallel the claims data that are for us to consider in developing data management of a patient. Finally, a available in pricing other PFS services. collection mechanisms, including that mechanism for reporting the However, we believe that the many post-operative services do not postoperative care occurs outside of in- information collected through this data have CPT codes to bill separately, that person visits and by clinical staff was collection will be a significant surgeons perform a wide range of needed. The report noted that in the improvement over the information collaborative care services, and that inpatient setting in particular, surgeons currently available to value these patient factors, including disease spend considerable time reviewing test services and will be supplemented with severity and comorbidities, influence results and coordinating care with other information obtained through other what post-operative care is furnished. practitioners. mechanisms. To assist us in determining After reviewing various approaches, a In the following sections, we discuss appropriate coding for claims-based set of time-based, post-operative visit the comments on each element of our reporting, we added a task to the RAND codes that could be used for reporting data collection proposal, our responses validation contract for developing a care provided during the post-operative and our final decision. model to validate the RVUs in the PFS, period was recommended. which was awarded in response to a The recommended codes distinguish (a) Information To Be Reported requirement in the Affordable Care Act. services by the setting of care and A key element of claims-based Comments that we received on the whether they are furnished by a reporting is using codes that validation report suggested the models physician/NPP or by clinical staff. All appropriately reflect the services did not adequately address global codes are intended to be reported in 10- furnished. In response to the comment surgery services due to the lack of minute increments. A copy of the report

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is available on the CMS Web site under http://www.cms.gov/physicianfeesched/ the services actually furnished but not downloads for the CY 2017 PFS downloads/. paid separately because they are part of proposed rule with comment period at We proposed the following no-pay global packages. codes be used for reporting on claims

TABLE 9—PROPOSED GLOBAL SERVICE CODES

Inpatient ...... GXXX1 Inpatient visit, typical, per 10 minutes, included in surgical package. GXXX2 Inpatient visit, complex, per 10 minutes, included in surgical package. GXXX3 Inpatient visit, critical illness, per 10 minutes, included in surgical package. Office or Other Outpatient ...... GXXX4 Office or other outpatient visit, clinical staff, per 10 minutes, included in surgical package. GXXX5 Office or other outpatient visit, typical, per 10 minutes, included in surgical package. GXXX6 Office or other outpatient visit, complex, per 10 minutes, included in surgical package. Via Phone or Internet ...... GXXX7 Patient interactions via electronic means by physician/NPP, per 10 minutes, included in surgical package. GXXX8 Patient interactions via electronic means by clinical staff, per 10 minutes, included in surgical package.

(i) Coding for Inpatient Global Service documentation that indicates what (ii) Coding for Office and Other Visits services were provided that exceeded Outpatient Global Services Visits Our proposal included three codes for those included in a typical visit. In the For the three codes in our proposal reporting inpatient pre- and post- proposed rule, we noted some that would be used for reporting post- operative visits that distinguish the circumstances that might merit the use operative visits in the office or other intensity involved in furnishing the of the complex visit code are secondary outpatient settings, codes, time would services. Under this proposal, visits that management of a critically ill patient be defined as the face-to-face time with involve any combination or number of where another provider such as an patient, which reflects the current rules the services listed in Table 10, which intensivist is providing the primary for time-based outpatient codes. were recommended by the contractor as management, primary management of a Like GXXX1, GXXX5 (Office or other those in a typical visit, would be particularly complex patient such as a outpatient visit, typical, per 10 minutes, reported using GXXX1. Based on the patient with numerous comorbidities or included in surgical package) would be findings from the interviews and the high likelihood of significant decline or used for reporting any combination of TEP, the report indicated that the vast death, management of a significant activities in Table 10 under our majority of inpatient post-operative complication, or complex procedures proposal. visits would be expected to be reported outside of the operating room (For We proposed only face-to-face time using GXXX1. example, significant debridement at the spent by the practitioner with the bedside). patient and their family members would TABLE 10—ACTIVITIES INCLUDED IN count toward the time reported with the TYPICAL VISIT (GXXX1 & GXXX5) The highest level of inpatient pre- and office visit codes. post-operative visits, critical illness (iii) Coding for Services Furnished via Review vitals, laboratory or pathology results, visits (GXXX3—Inpatient visit, critical imaging, progress notes. illness, per 10 minutes, included in Electronic Means Take interim patient history and evaluate surgical package) would be reported Services that are furnished via phone, post-operative progress. when the physician is providing the internet, or other electronic means Assess bowel function. primary management of the patient at a outside the context of a face-to-face visit Conduct patient examination with a specific would be reported using GXXX7 when focus on incisions and wounds, post-sur- level of care that would be reported gical pain, complications, fluid and diet in- using critical care codes if it occurred furnished by a practitioner and GXXX8 take. outside of the global period. This when provided by clinical staff under Manage medications (for example, wean pain involves acute impairment of one or our proposal. We proposed that medications). more vital organ systems such that there practitioners would not report these Remove stitches, sutures, and staples. is a high probability of imminent or life services if they are furnished the day Change dressings. before, the day of, or the day after a visit Counsel patient and family in person or via threatening deterioration in the patient’s condition. as we believe these would be included phone. in the pre- and post-service activities in Write progress notes, post-operative orders, Similar to how time is now counted the typical visit. However, we proposed prescriptions, and discharge summary. for the existing CPT critical care codes, Contact/coordinate care with referring physi- that these codes be used to report non- cian or other clinical staff. we proposed that all time spent engaged face-to-face services provided by Complete forms or other paperwork. in work directly related to the clinical staff prior to the primary individual patient’s care would count procedure since global surgery codes are Under our proposal, inpatient pre- toward the time reported with the typically valued with assumptions and post-operative visits that are more inpatient visit codes; this includes time regarding pre-service clinical labor time. complex than typical visits but do not spent at the immediate bedside or Given that some practitioners have qualify as critical illness visits would be elsewhere on the floor or unit, such as indicated that services they furnish coded using GXXX2 (Inpatient visit, time spent with the patient and family commonly include activities outside the complex, per 10 minutes, included in members, reviewing test results or face-to-face service, we believed it was surgical package). To report this code, imaging studies, discussing care with important to capture information about the practitioner would be required to other staff, and documenting care. those activities in both the pre- and furnish services beyond those included post-service periods. We also believed in a typical visit and have these requirements to report on clinical

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labor time are consistent with and no stakeholders noting that practitioners it as a ‘‘post-operative follow-up’’ more burdensome than those used to are familiar with this existing CPT code service. report clinical labor time associated and the burden on practitioners would We also sought comment on whether with chronic care management services, be minimized by only having to report time of visits could alone be a proxy for which similarly describe care that takes that a visit occurred, not the level of the the level of visit. If pre- and post- place over more than one patient visit, we noted that we did not believe operative care varies only by the time encounter. that this code alone would provide the the practitioner spends on care so that In addition, we proposed for services information that we need for valuing time could be a proxy for complexity of furnished via interactive surgical services nor do we believe it the service, then we could use the telecommunications that meet the alone can meet the statutory reporting of CPT code 99024 in 10- requirements of a Medicare telehealth requirement that we collect data on the minute increments to meet the statutory service visit, the appropriate global number and level of visits. Given the requirement of collecting claims-based service G-code for the services would be strong support for the use of CPT code data on the number and level of visits. reported with the GT modifier to In addition to comments on whether 99024, we solicited comments indicate that the service was furnished time is an accurate proxy for level of specifically on how we could use this ‘‘via interactive audio and video visit, we solicited comment on the code to capture the statutorily required telecommunications systems.’’ feasibility and desirability of reporting data on the number and level of visits CPT code 99024 in 10-minute (iv) Rationale for Use of G-Codes and the data that we would need to increments. After considering the contractor value global services in the future. The following is a summary of the report, the comments in response to the We also discussed in the proposed comments that we received on our comment solicitation in the CY 2016 rule our concern that using CPT code proposal to use G-codes for reporting proposed rule and other stakeholder 99024 with modifiers to indicate to the services furnished during the pre- input that we have received, and our which of the existing levels of E/M and post-operative periods of 10- and needs for data to fulfill our statutory codes the visit corresponds may not 90-day global services. mandate and to value surgical services accurately capture what drives greater Comment: Many commenters offered appropriately, we proposed this new set complexity in post-operative visits. We critiques of the G-codes. Most objected of codes because we believe it provides noted that as outlined in the contractor’s to reporting using the proposed G-codes. us the most robust data upon which to report, E/M billing requirements are Some commenters raised concerns with determine the most appropriate way and built upon complexity in elements such the code definitions. These included: amounts to pay for PFS surgical as medical history, review of systems, Lack of alignment with clinical services. We noted that these proposed family history, social history, and how workflow, failure to adequately account codes would provide data of the kind many organ systems are examined. In for variation in complexity and medical that can reasonably collected through the context of a post-operative visit, decision-making, and use of the term claims data and that reflect what we many of these elements may be ‘‘typical’’ to define visits in a different believe are key issues in the valuation irrelevant. The contractor’s report also way than the term is generally used in PFS valuations. One commenter of post-operative care—where the notes that there was significant concern suggested that CMS should require care service is provided, who furnishes the from interviewees and the expert panel plans for outpatient visits in the postservice, its relative complexity, and the about documentation that is required for operative period. It was also suggested time involved in the service. reporting E/M codes. Specifically, they We solicited public comments about that the complex visit code could be stated that documentation requirements all aspects of these codes, including the improved by using a term other than for surgeons to support the relevant E/ nature of the services described, the ‘‘complex’’ in the definition. A M visit code would place undue time increment, and any other areas of commenter questioned whether that administrative burden on surgeons interest to stakeholders. We noted vast majority of cases would be complex particular interest in any pre- or post- given that many surgeons currently use instead of ‘‘typical,’’ since the definition operative services furnished that could minimal documentation when they of ‘‘complex’’ included management of not be appropriately captured by these provide a postoperative visit. We also a patient with multiple comorbidities codes. We solicited comments on noted that to value surgical packages and most Medicare beneficiaries have whether the proposed codes were accurately we need to understand the multiple comorbidities. A commenter appropriate for collecting data on pre- activities involved in furnishing post- also suggested that CMS refine the operative services. We also sought operative care and as discussed above, G-codes to distinguish physician visits comment on any activities that should we lack information that would from NPP visits. In addition, several be added to the list of activities in Table demonstrate that activities involved in commenters objected to the proposed 10 to reflect typical pre-operative visit post-operative care are similar to those G-codes for on-line and telephone activities. in E/M services. In addition, the use of services because they believed it would modifiers to report levels of services is be nearly impossible to track these data (v) Alternative Approach to Coding more difficult to operationalize than and extremely burdensome to do so. In making the proposal for G-codes, using unique HCPCS codes. However, Commenters indicated that the G-codes we noted that many stakeholders had we sought comments on whether, and if were not well-defined overall and expressed strong support for the use of so, why, practitioners would find it should not be used without testing to CPT code 99024 (Postoperative follow- easier to report CPT code 99024 with determine their validity. up visit, normally included in the modifiers corresponding to the Response: We appreciate the detailed surgical package, to indicate that an proposed G-code levels rather than the comments on the design of the G-codes evaluation and management service was new G-codes, as proposed. We also and the concerns regarding their performed during a post-operative sought comment on whether limitations in appropriately reflecting period for a reason(s) related to the practitioners would find it difficult to the services furnished in 10- and 90-day original procedure) to collect data on use this for pre-operative visits since the global periods. These comments provide post-operative care. In response to CPT code descriptor specifically defines information for how the G-codes could

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be modified to better reflect services global services than for other comply with the statutory requirement furnished in global periods, however, as practitioners. However, based on the to gather the data necessary to value is discussed at the outset of this section, comments, it is clear that many global procedures. We note that CPT we are not using the proposed G-codes practitioners would perceive reporting routinely incorporates more than 100 for this data collection effort. of time involved in furnishing these new codes in annual updates, and for Comment: Most commenters objected services to be a significant increase in this reason we did not anticipate that to using codes based on time increments burden relative to existing practice. the inclusion of eight new G-codes was and the proposed 10-minute increments, Before implementing a change likely to present significant challenges specifically. Some stated that reporting considered by so many to be so to EHR systems or other infrastructure. of services by time did not reflect the burdensome, we are exploring other Based on the comments we received, way surgeons practiced and would ways of obtaining information that can however, it is clear that the majority of divert practitioners from patient care. be used to improve the accuracy of stakeholders believe the burden is much One commenter stated that it was not valuing these services. Accordingly, we greater than we had assumed. In feasible for practitioners to collect time are not finalizing, at this time, the general, we agree with commenters that data for every task that they or their requirement to use time-based codes. comparable documentation is clinical staff performed. Another stated Comment: Many commenters stated appropriate for all physicians furnishing that requesting physicians and/or their that the use of these codes would be and being paid by Medicare for similar staff to use a stop-watch to, in effect, costly, requiring extensive education of services. conduct time and motion studies for all practitioners and staff and necessitating Comment: Several commenters noted their non-operating room patient care updates to EHR systems and billing that the difficulties of using these codes activities is an incredible burden. software. Some also noted the cost of would affect the accuracy of the data Another stated that reporting time in 10- processing additional claims. Many reported. One commenter stated that the minute increments ‘‘is untenable,’’ commenters noted that this would be G-code proposal would be impossible to noting that, except for a few specialties, particularly difficult as this additional implement and ‘‘at the very least’’ physicians do not think of providing administrative burden would come at would yield incomplete and unreliable care in terms of timed increments. The the same time practitioners are adjusting results. commenter added that surgeons, in the Merit-based Incentive Payment Response: We agree with commenters particular, are not accustomed to System (MIPS). One commenter that implementation burden is an reporting time for all pre- and post- provided the results of a survey of important consideration in determining operative visits and to do so would be surgical practitioners in 20 specialties in how practitioners should report on care a huge disruption to workflow. In which 30 percent of respondents stated provided in the post-operative period addition to objections about the burden that the cost of integrating the new G- and that if practitioners find the of reporting time data, some codes into their practice would cost reporting requirements to be excessive commenters objected to the use of time more than $100,000 and only about 10 and require great expenditures to data as a factor in valuations. percent stated that it would cost less incorporate into their practice, the Three organizations commented that than $25,000. accuracy of the data could be it was appropriate to collect time data, Some commenters expressed specific undermined. We considered this in but recommended that we do so based concern about the documentation determining the final policy described upon 15-minute increments as these burden that would come from using below. were more familiar to physicians than these codes. On the other hand, other Comment: Some commenters the proposed 10-minue increments. In commenters suggested that providers of criticized the proposed G-codes because addition, some other groups, including visits during the global surgical services they were not directly linked to E/M MedPAC, agreed that data on time was should be held to the same codes or comparable to existing E/M needed for valuations. documentation standards as providers codes. On the other hand, some Response: Time is a key factor in of E/M services. One stated that the commenters preferred the codes valuing physician services under the ‘‘administrative burden on surgeons describing such visits not be linked or physician fee schedule. Section should be no different and certainly no comparable to E/M codes to avoid 1848(c)(1) of the Act defines the work less than that on non-surgeons when it confusion or unintentional, component as the portion of the comes to documenting a visit with a inappropriate payments. One resources used in furnishing the service patient. If many surgeons currently use commenter stated that the follow-up that reflects physician time and minimal documentation when they work performed within the global intensity in furnishing the service. We provide a post-operative visit that is no periods and the continuity work also note that time-based codes are used excuse for expecting the same performed by cognitive physicians by practitioners for a range of services inadequate level of documentation should not be represented by the same in the PFS including psychotherapy, going forward. To require anything less codes. Another commenter stated that anesthesiology and critical care services. than the same level of documentation the care required by a patient recovering Critical care services are notable for all clinicians providing E/M services from a procedure is fundamentally because these services are likely to be would be irresponsible and unfair and different from the typical follow-up of furnished intermittently as many would defeat the very purpose of an established outpatient or inpatient, commenters suggested is typical for documenting the actual types and extent especially when there are multiple post-operative follow-up services. Since of these services in the post-operative simultaneous interacting conditions, a issues have not been raised about the period.’’ single metastable chronic illness, or one difficulty of using the current critical Response: The need for accurate, or more acute exacerbated chronic care codes, it is unclear why reporting complete and useful data must be illnesses that requires inpatient care and of time would be burdensome and balanced with administrative burden expertise. disruptive of care in this area. We have and cost. We articulated that using a Response: Commenters’ belief that the no reason to believe the documentation select number of G-codes based on time work in follow-up visits included in the of time is more difficult or burdensome would impose a burden on providers, global package is not necessarily well for those furnishing 10- and 90-day but that burden is necessary for us to described by the work of current E/M

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codes is worth exploring. Current data clinical registries, or on-line portals be to report such visits. We will not, at this does not allow us to determine the used to collect data on level of visits. time, require time units or modifiers to validity of these commenters’ assertion Several commenters stated that CMS distinguish levels of visits to be but given its importance, we believe it should not collect data on the level of reported. Since this code is specifically is critical to gather data on whether visits based on these commenters’ limited to post-operative care, we are follow-up visits provided in the post- perspective that there is no problem only requiring reporting of post- operative period are different than other with the level of visits currently used in operative visits. We expect that the E/M services. To the extent the services the valuation of global packages. One reporting of this information through in the post-operative period are different commenter pointed out that only 1 Medicare claims will provide us with from other E/M services, it would not percent of all established patient office information about the actual number of visits used in valuing 10-day and 90-day make sense to use E/M codes in valuing visits furnished during the post- global surgery packages have a visit global services as is ostensibly the case operative periods for many services under the current process the RUC uses level above a CPT code 99213. Another commenter suggested that the survey be reported using global codes. Because the in developing recommended values for number of visits is a major factor in PFS services. used to collect data on the level of visits. Others suggested that RUC valuation of global services, we believe Comment: Most commenters that examination of such information, supported using CPT codes, rather than surveys be used to measure level of visits. when available, can improve the the proposed G-codes. A few pointed to accuracy of the global codes. The use of the existing E/M codes, but most Response: We understand that a simple code that practitioners are recommended that any claims-based stakeholders believe that using CPT familiar with should facilitate the reporting use CPT code 99024, an code 99024 rather than the proposed G- submission of accurate information. We existing CPT code that describes post- codes will significantly lower operative services in a global period. administrative burden and lower costs expect practitioners to note the visit in Commenters noted that since this is a related to the collection of this data. We the medical chart documenting the post- current CPT code the administrative do not have data showing that the level operative visit. burden would be much less than that of visits used in valuation of global Since CPT code 99024 will only packages are correct or incorrect; to the associated with using the proposed new provide data on the number of visits and best of our knowledge, this has never G-codes. These commenters suggest that no data on the level or resources used been assessed outside of the RUC practitioners are likely already familiar in furnishing the visit, we believe this process. While the current valuations with the code, some already use it to for global packages rely primarily on is only the first step in gathering the track services within their practice, and CPT codes 99212 and 99213 for the visit data required by Section 1848(c)(8). The some others already report it to other component, we do not agree that this proposed G-codes could have provided payers. Also, they suggest that because means that the levels are accurate. information to better understand the EHR and billing systems already include Further, as some commenters have resources used in furnishing services CPT code 99024, it will be less costly to made clear, there is not consensus during global periods and in valuation implement than the proposal. Some also among stakeholders that the post- of such services assuming that they preferred using CPT code 99024 because operative visits are equivalent to other could be accurately reported. However, unlike the proposed G-codes it does not E/M visits. Additionally, the widespread concerns from groups require the reporting of time units. relationship between the number and representing the practitioners that Most commenters disagreed that time level of visits assumed to be in the would be reporting these services, could be a proxy for the complexity of global period and the overall work including concerns about the burdens the visit and objected to reporting time RVUs for the global codes is often regarding and the inability of physicians for the same reasons discussed above. unclear. For all of these reasons, we to track time and the need to learn a These commenters did not agree that disagree with commenters that we do new 8-code coding system, persuade us CPT code 99024 could be reported in not need to collect data on the level of that we should pursue less burdensome time units as a proxy for collecting the services. ways of obtaining information. We will required information about the level of In addition to the statutory reference assess whether these methods will lead visits. to collecting data on the level of visits, to the collection of necessary data, Three organizations disagreed, we believe that code valuations can be including data on time and intensity, of however, stating that time is a sufficient more accurate with more complete these services. proxy for work relativity in post- information. While we continue to operative visits and that the number believe that data only on the number of As suggested by commenters, we will units of CPT code 99024 could reflect visits furnished would not provide data explore whether the data collected from the complexity involved. These on both the number and level of visits the survey that we are conducting, commenters recommended reporting needed for valuation of services, data on which is discussed later in this data in 15-minute intervals, rather than the number of visits alone is an preamble, can provide information on the proposed 10-minute increments, important input in valuing global the level of visits and other resources stating that physicians are familiar with packages and having accurate data on needed to value surgical services 15-minute increments and thus the use the number of visits could be a useful accurately. Stakeholders should be of 15-minute increments would greatly first step in analyzing the global aware that since this a new approach for reduce the administrative burden. They packages. collecting data, and one that has not recommended that CMS clearly define After considering the comments, we been used previously, we are concerned how time is to be reported and are finalizing a requirement to report that additional or different reporting suggested that the 8-minute rule is post-operative visits furnished during will be necessary to collect data on the already a familiar concept that could be 10- and 90-day global periods. However, number and level of visits and other used. rather than using the proposed set of G- information needed to value surgical Many commenters suggested that codes for this reporting, we are services as required by Section other approaches, such as a survey, requiring that CPT code 99024 be used 1848(c)(8).

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b. Reporting of Claims by more than 100 providers and that similarly be used to value low-volume We proposed that the G-codes either are furnished more than 10,000 services in the same family. As a result detailed above would be reported for times or have allowed charges of more we, believe that the data on high- services related to and within 10- and than $10 million annually to obtain volume services can improve the 90-day global periods for procedures meaningful data for valuation. The RUC accuracy of values for all 10- and 90-day furnished on or after January 1, 2017. noted that many procedures were services. After consideration of the comments, Services related to the procedure infrequently furnished and thus useful we are implementing a requirement for furnished following recovery and data would not be obtained. This reporting on services that are furnished otherwise within the relevant global position was supported by a significant by more than 100 practitioners and are period would be required to be reported. number of commenters. In response to the stated concern about having either furnished more than 10,000 times These codes would be included on complete data when more than one or have allowed charges of more than claims filed through the usual process. surgical service is furnished during the $10 million annually as recommended Through this mechanism, we would global period, a commenter pointed out by the RUC and many other collect all of the information reported that a review of the 2014 Medicare 5 commenters. Under this policy, we on a claim for services, including percent sample file shows that, two estimate that we would collect data on information about the practitioner, surgical global codes are performed on about 260 codes that describe service furnished, date of service, and the same date of service, by the same approximately 87 percent of all the units of service. By not imposing physician, only 18 percent of the time. furnished 10- and 90-day global services special reporting requirements on these Response: The commenters are correct and about 77 percent of all Medicare codes, we proposed to allow that the vast majority of 10- and 90-day expenditures for 10- and 90-day global practitioners the flexibility to report the procedures are furnished infrequently services under the PFS. Given that this services on a rolling basis as they are and thus have little effect on Medicare data would provide information on the furnished or to report all of the services expenditures or direct impact on the codes describing the vast majority of 10- on one claim once all have been valuations of other services under the and 90-day global services and furnished, as long as the filed claims PFS. We proposed to collect data on all expenditures, it will provide significant meet the requirements for filing claims. procedures since we believed the data data for valuation. For 2017, we will use We did not propose any special we collected would be more accurate if the CY 2014 claims data to determine requirements for inclusion of additional physicians reported on all services as it the codes for which reporting is data on claims that could be used for would be routine and would not have required and display the list on the CMS linking the post-operative care required physicians to determine at Web site. In subsequent years, we will furnished to a particular service. To use each pre- and post-operative visit update the list to reflect more recent the data reported on post-operative whether or not reporting the service was claims data and publish a list of codes visits for analysis and valuation, we required. Moreover, as pointed out by prior to the beginning of the reporting proposed to link the data reported on commenters, we believe that reporting year. The services for which reporting is post-operative care to the related on all applicable services would have required will include successor codes to procedure using date of service, provided more complete data when those deleted or modified since CY 2014 practitioner, beneficiary, and diagnosis. multiple surgeries occurred during the for which reporting would have been While we believed this approach to global period. required if the code had not been matching would allow us to accurately Having specific data on all procedures deleted or modified. link the preponderance of G-codes to would provide specific information for The following is summary of the the related procedure, we sought each service that Medicare pays for comments we received on our proposal comment on the extent to which post- using a global period. In assessing the to require claims-based reporting for operative care may not be appropriately likely benefit of the additional data as services related to procedures furnished linked to related procedures whether we compared to the burden of reporting on or after January 1, 2017. should consider using additional based on the comments we received, we Comments: Many commenters variables to link these aspects of the agree with commenters that collecting expressed concerns regarding the care, and whether additional data the data from high volume/high cost difficulty of making the changes should be required to be reported to procedures could provide adequate required to implement this new enable a higher percentage of matching. information to improve the accuracy of reporting by January 1, 2017. Some The following is summary of the valuation of global packages overall. commenters noted that this change was comments we received on our proposal Even if all practitioners reported data on coming at the same time as the new to require reporting on pre- and post- all procedures, it is likely that we would MIPS program. Some commenters stated operative care associated with all not receive enough data on low-volume that the statute required a process to be procedures with 10- and 90-day global services for the data to be reliable for in place by January 1, 2017, but that periods. use in valuations. There are more than CMS has flexibility regarding when to Comment: Many commenters objected 1,500 services that are furnished less begin the required reporting. Some to the proposal to require reporting on than 100 times per year. Because of this, commenters suggested that CMS post-operative services for all 10- or 90- data that we could collect on these consider conducting the proposed day global services. Some suggested that services would be extremely limited. survey before implementing any claims- many of the global services are low We also find that data on services with based reporting. volume and have little impact on low volumes are not reliable due to Response: We proposed to begin Medicare spending. It was also noted variability from year to year. Since we required reporting on January 1, 2017, that it would be difficult to obtain a often value related services by based upon the statutory language meaningful sample of low-volume extrapolating data on one service to regarding both the collection and use of services. Others discussed the burden of other services in the family, with the data for revaluation of services. We reporting on all services. The RUC adjustments as necessary to reflect understand that some practices will recommended that CMS only require variations in the procedure, the data need to make modifications to their EHR reporting on services that are furnished gathered on high-volume services could and billing systems to report this data to

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us. We also acknowledge that an teaching surgeons report to CMS for the include specialty, practice size opportunity for testing the systems and reporting of CPT code 99024. More (including solo practices), practice training will enhance the quality of data specifically, when the appropriate setting, volume of claims, urban, rural, that we receive. conditions are met they would use the type of surgery, and type of health care After consideration of comments, we GC or GE modifier to identify those delivery systems. Another commenter are encouraging practitioners to begin services in which surgical residents are pointed out that small sample sizes may reporting data on post-operative services involved. One of these suggested that lead to unreliable data. Some for procedures furnished on or after once we have the data we discuss with commenters stated that requiring all January 1, 2017. However, the stakeholders how to use the data practitioners to report this information requirement to report will become involving residents in future valuations. is unreasonable and would be an mandatory for post-operative services Others suggested that we capture data insurmountable burden. A participant related to procedures furnished on or on resident’s time as it could be acknowledged that it would be difficult after July 1, 2017 rather than as of important for valuation, especially for for practitioners to report on only January 1, 2017, as proposed. This delay the more complex cases in a teaching certain procedures, while another stated will not negatively impact the use value facility setting. Some urged that we that this would not be an administrative of the collected data since we expect provide clear guidance on when the burden. that data received early in the year resident’s time could be reported. One After considering the input of might be less complete than data commenter stated that teaching stakeholders on the CY 2016 proposed submitted once practitioners adjusted to physicians should be exempt from rule and at the January 2016 national the requirements. Also, by allowing reporting requirements. listening session discussed above, we time for practitioners to adjust EHR and Response: These comments reinforce proposed that any practitioner who billing software, to test such systems the importance of collecting data from furnishes a procedure that is a 10- or 90- and to train staff, we think the quality teaching physicians and to do so using day global service report the pre- and of the data will be enhanced by the existing Medicare rules that teaching post-operative services furnished on a providing flexibility with regard to the physicians use in reporting services in claim using the proposed G-codes. We effective date of the requirement. which residents are involved in agreed with stakeholders that it would Finally, because we are limiting furnishing. Because we are finalizing be necessary to obtain data from a required reporting to high-volume data collection using CPT code 99024, broad, representative sample. However, codes, meaningful data for CY 2017 the issues regarding the reporting of as we struggled to develop a nationally should be available from 6 months of time data are no longer relevant. representative sampling approach that reporting. Our systems can now accept After consideration of the comments, would result in statistically reliable and the post-operative visit data so we are finalizing a requirement that valid data, it became apparent that we practitioners can begin submitting such teaching physicians will be subject to do not have adequate information about claims at any time. the reporting requirements in the same how post-operative care is delivered, way that other physicians are. Such how it varies and, more specifically, c. Special Provisions for Teaching physicians should report CPT code what drives variation in post-operative Physicians 99024 only when the services furnished care to develop a sampling frame. In its We sought comment on whether would meet the general requirements for work to develop the coding used for its special provisions are needed to capture reporting services and should use the study, the contractor found a range of the pre- and post-operative services GC or GE modifier as appropriate. opinions on what drives variation in provided by residents in teaching e. Who Reports post-operative care. (The report is settings. If the surgeon is present for the available on the CMS Web site under key portion of the visit, should the In both the comments on the CY 2016 downloads for the CY 2017 PFS surgeon report the joint time spent by proposed rule and in input from the proposed rule with comment period at the resident and surgeon with the January 2016 national listening session, http://www.cms.gov/physicianfeesched/ patient? If the surgeon is not present for there was a great deal of discussion downloads/.) Without information on the key portion of the visit, should the regarding the challenges that we are what drives variation in pre- and post- resident report the service? If we value likely to encounter in obtaining operative care, we would have to services without accounting for services adequate data to support appropriate speculate about the factors upon which provided by residents that would valuation. Some indicated that a broad to base a sample or assume that the otherwise be furnished by the surgeon sample and significant cooperation from variation in such care results from the in non-teaching settings, subsequent physicians would be necessary to same variables as are frequently valuations based upon the data we understand what is happening as part of identified for explaining variation in collect may underestimate the resources the global surgical package. One health care and clinical practice. In used, particularly for the types of commenter suggested that determining a addition, we expressed concern about surgeries typically furnished in teaching representative sample would be difficult whether a sample could provide facilities. However, there is also a risk and, due to the variability related to the sufficient volume to value accurately of overvaluing services if the reporting patient characteristics, it would be the global package, except in the case of includes services that are provided by easier to have all practitioners report. a few high-volume procedures. residents when those services would Many suggested that we conduct an In addition to concerns about otherwise be furnished by a physician extensive analysis across surgical achieving a statistically representative other than the surgeon, such as a specialties with a sample that is sample of all practitioners nationally, hospitalist or intensivist, and as such, representative of the entire physician we noted in the proposed rule should not be valued in the global community and covers the broad significant operational concerns with package. spectrum of the various types of limiting data collection to a subset of Comment: We received only a few physician practice to avoid problems practitioners or a subset of services. comments on this issue. Some that biased or inadequate data collection These include how to gain sufficient commenters suggested using the CMS would cause. Suggestions of factors to information on practitioners to stratify policies that apply to other services that account for in selecting a sample the sample, how to identify the

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practitioners who must report, and for approach at the practice level as smaller, rural practices have smaller those who practice in multiple settings compared to a requirement for all global patient populations, which can often be or with multiple groups in which services would result in less reliable older and sicker than the typical patient settings the practitioner would report. data being reported. seen in a large practice and by creating We concluded that establishing the We noted that as we analyzed the data a complex system that favors one type rules to govern which post-operative collected and made decisions about of practice, the collected data is more care should be reported based on our valuations, we would reassess the data likely to be biased rather than proposed G-codes would be challenging needed and what should be required representative. Another commenter for us to develop and difficult for from whom. Through the data collected suggested that a small number of physicians to apply in the limited time under our proposal, we indicated that representative practices could provide between the issuance of the CY 2017 we would have the information to assess us with the same level of accuracy as PFS final rule with comment period and whether the post-operative care collected data from all physicians. the beginning of reporting on January 1, furnished varies by factors such as Response: In response to commenters’ 2017. We do not believe that the same specialty, geography, practice setting, opposition to our proposal to require all problems apply to the same extent to and practice size, and thus, the providers of covered services to report our final policy to use a single code that information needed for a sample data, we acknowledge that the already exists to report services selection to be representative. stakeholders describe a much larger described only by codes reported in While section 1848(c)(8)(B) of the Act burden from using the G-codes than we high volumes. For example, requires us to collect data from a anticipated. On the other hand, we also implementation of new sets of codes representative sample of physicians on believe that our final policy will result associated with annual PFS updates are the number and level of visits provided in a much lower burden than the often supported by informational and during the global period, we stated that proposed policy would have. As noted educational efforts undertaken by it does not prohibit us from collecting above, we are not finalizing the national organizations, like the national data from a broad set of practitioners. In proposed requirements to use the G- medical specialty societies. Given that addition, section 1848(c)(2)(M) of the codes or the proposed requirement to Act authorizes the collection of data many practitioners are already familiar report on all 10- and 90-day global from a wide range of physicians. Given with CPT code 99024 (as noted by many procedures and thus, we believe that the the benefits of more robust data, commenters), the need for such efforts overall administrative burden is including avoiding sample bias, is significantly mitigated. significantly reduced. We also noted in the proposed rule obtaining more accurate data, and We do not agree with commenters that the more robust the reported data, facilitating operational simplicity, we that state that we do not have the the more accurate our ultimate noted that we believed collecting data statutory authority to require reporting valuations can be. We stated that given on all post-operative care initially is the by all practitioners furnishing certain the importance of data on visits in best way to undertake an accurate services. We point commenters to accurate valuations for global packages, valuation of surgical services in the collecting data on all pre- and post- future. section 1848(c)(2)(M) of the Act, which operative visits in the global period is The following is a summary of the authorizes the collection of data to use the best way to accurately value surgical comments that we received on our in valuing PFS services. We continue to procedures with global packages. proposal to require all practitioners believe that section 1848(c)(8) of the Act We recognized that reporting would furnishing 10- or 90-day global services requires us to collect data that is require submission of additional claims to submit claims for the pre- and post- representative. We also continue to by those practitioners furnishing global operative services furnished. believe that requiring all practitioners to services, but indicated that we believed Comment: Commenters report is more likely to be representative the benefits of accurate data for overwhelmingly opposed requiring all than a sample given our lack of valuation of services merited the practitioners to submit claims for information about what drives variation imposition of this requirement. By using postoperative services. Several reasons in post-operative care. However, after the claims system to report the data, we were cited for the opposition. The most considering the information presented believed the additional burden would significant reason was the by commenters regarding the difficulties be minimized and referred to administrative burden and costs to that would be placed on many stakeholder reports that many physicians. Many commenters also physicians by the proposal, we believe practitioners are already required by stated that requiring all practitioners that requiring reporting by all their practice or health care system to who furnish 10- or 90-day global practitioners for CY 2017 may present report a code for each visit for internal services to report data is counter to the unforeseen, alternative impediments to control purposes and some of these statute because the statute refers to the sample being nationally systems already submit claims for these collection of data from a representative representative of all practitioners, such services, which are denied. We noted sample of physicians. as practitioners being unable to report that requiring only some physicians to One commenter stated that requiring data accurately due to constraints of report this information, or requiring every practitioner to report these codes time, finances or technical ability. reporting for only some codes, could will be in many ways less representative Comment: We did not receive any actually be more burdensome to than a targeted sample, explaining that comments on the appropriate sample physicians than requiring this given the limited time for education, size. Nor did we receive data on information from all physicians on all only large, technologically rich practices variations in the delivery of post- services because of the additional steps will have the ability to properly report operative care in response to our necessary to determine whether a report these services. The commenter noted concern that we lacked data on how is required for a particular service and that this will leave many, smaller or post-operative care was delivered to adopting a mechanism to assure that rural practices without the proper select a representative sample. Many data is collected and reported when education and robust billing systems in commenters stated that it was possible required. Moreover, we stated that the place to adequately, if at all, report these to select a representative sample, but challenges with implementing a limited G-codes. The commenter also noted that none provided details on how to do so.

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Several commenters suggested required reporter furnishes a procedure be representative. We also believe that broadly sampling using the and another practitioner in the practice submission by all practitioners would characteristics that are frequently used furnishes the post-operative visits. A be consistent with our extensive use of for health care sampling generally, such geographic approach also makes it claims data for other PFS services. as geographic areas, urban and rural, easier to educate practitioners on data Additionally, we understand the statute practice types, practice sizes, specialties collection requirements. directs us to gather data from more than and academic and non-academic. One Comment: In response to operational a select group of practitioners based on commenter recommended that we select difficulties with a representative any particular attributes, such as a sample using geographical data to sample, such as how to make sure gathering data only from ‘‘efficient’’ identify a sample including practices of participants were aware of the practices, consistent with longstanding all sizes. The commenter suggested, for requirement to report and how to do so, recommendations from MedPAC example, that large hospital-based one commenter stated that notifying a regarding limiting data collection. We practices often have practice patterns small targeted sample is a much smaller also believed that there were significant that are different from the majority of task than notifying the entire population operational impairments to data the practicing physicians in suburban of participating Medicare practitioners. reporting by a limited sample of and rural areas. Another commenter They also stated that a targeted physicians. In consideration of these stated that we should not only collect approach will encourage open dialogue factors, we proposed to require data from MSAs but also from rural and between the participating practices and reporting by all physicians to make sure less urban areas. CMS, ensuring the data collected are that the data we obtained reflected all One commenter suggested that we reliable. Others suggested providing services furnished. In light of the consider phasing in the requirement, compensation for a sample of comments regarding the burden that perhaps starting with larger groups. The physicians to submit detailed data, would be created by requiring reporting commenter stated that through one of would lead to capturing accurate data by all physicians and the data that was these approaches we could avoid because they would more likely to actually needed for valuation, we think ‘‘burdening providers with unfunded understand and prioritize reporting that reporting by a subset of work that has not yet been tested.’’ because of their participation in this practitioners could provide us valuable One commenter suggested that we use type of study. information on the number of visits a geographic sampling approach similar Response: We disagree that it is typically furnished in global periods. to that one used for Comprehensive Care operationally easier to notify a small This data could enhance the for Joint Replacement (CJR) model or the segment of broadly diverse practitioners information we currently use to episode payment models proposed for than the entire population of establish values for these services. cardiac and surgical hip/femur fraction practitioners unless that small segment While we acknowledge that we believe and modify it to choose a geographic has a degree of cohesiveness, such as the data under this less burdensome sampling unit of MSAs and non-MSAs. being in the same geographic area or approach will provide less information Response: We agree with commenters specialty. We have long appreciated the than necessary for optimal valuation for that we could select a sample using an stakeholder community’s collaboration these services, we believe that the approach typically used in health care in broad communication efforts. In information on the number of actual surveys or in Medicare models and general, we have found that when visits from a subset of practitioners is other programs. To the extent that the something affects a small number of preferable to the information on which delivery of post-operative care varies providers it does not receive the same we currently rely, which is the results only based upon the criteria we response from entities that are critical of survey data reflecting respondents’ selected, a sample based on being for widespread adoption such as assessment of the number of visits representative for that criteria would be associations, who are key purveyors of considered to be typical. likely to produce valid data. information, and those developing One commenter suggested that we However, instead of sampling by software systems. We appreciate the could develop a geographic sample practice or practitioner or type of suggestion that interaction among those using a similar approach used by the service, a geographic approach to that need to report will facilitate Center for Medicare and Medicaid sampling (for example, sampling all compliance and the quality of the data. Innovation for the Comprehensive Care practitioners in a selected state) could With regard to compensation, we note for Joint Replacement (CJR) or other help to alleviate the need to stratify the that the statute provided for a 5 percent proposed episode payment models, with sample on a long list of criteria. By withhold to encourage compliance and an adjustment that would make certain using broad geographical areas from we chose not to propose to implement we received data from rural, as well as varied areas of the country, we believe this provision. urban areas. We reviewed these our sample will capture data from After consideration of the comments, approaches and concluded that such an practitioners who practice in a variety of we are finalizing a requirement for approach for sample selection could settings, single and multispecialty reporting that only applies to maximize the variability of the sample, practices, urban and rural, a variety of practitioners in selected states. In mitigate some of our concerns, and medical specialties, and practitioners addition, those practicing only in small provide a robust set of data for operating in both academic and non- practices are excluded from required consideration. academic institutions. Surgeons reporting. Those not required to report Commenters suggested a sample interviewed for the G-code development can do so voluntarily and we encourage should include geographic diversity. suggested that post-operative care might them to do so. Studies show that health care delivery vary across these dimensions. A patterns often vary between geographic geographic approach could also mitigate Geographic Sample areas and while we have no specific some of the practical operational As we noted in the proposed rule, we information that the number of post- barriers. For example, we believe that by do not have adequate data on what operative visits varies by geographic having all practitioners in the practice drives variations in the delivery of pre- areas, it seems prudent to gather data participate in reporting, we avoid and post-operative care to design a from a variety of geographic areas to concerns about incomplete data when a sampling methodology that is certain to determine if there is such variation and

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to account for it in our data collection Dakota, Utah, Vermont, West Virginia practices with fewer than 10 if it exists. In order to maximize the and Wyoming. practitioners, we estimate that about 45 variability of our limited sample, we are We also recorded the Census region percent of practitioners will not be using a methodology that requires for each state using the Census Bureau’s required to report. In defining small reporting from practices in 9 states of nine regions (New England, Middle practices, we reviewed other programs. various sizes and from various Atlantic, South Atlantic, East South We chose 10 practitioners as the geographic areas of the country. We are Central, West South Central, East North threshold for reporting as practices of using whole states for the geographic Central, West North Central, Mountain, this size are large enough to support areas rather than MSAs as are used for and Pacific). Puerto Rico and other coding and billing staff, which will the CJR and proposed for other models territories were excluded. make this reporting less burdensome. for several reasons. First, MSAs are not To ensure a mix of states in terms of Also, this is the same threshold used by used for geographic adjustments under size (measured by number of Medicare the value-based modifier program for its the PFS. Indeed, practitioners in most beneficiaries), we selected 1 state at phase-in of a new requirement because states receive state-wide geographic random from group 1, followed by 2 of concerns about the burden of small adjustments under the PFS. states each at random from groups 2 and practices. Additionally, an MSA-based approach 3, and lastly 4 states from group four. For this purpose, we define practices would, by definition, not include large After each random selection, we as a group of practitioners whose rural areas, something mentioned by eliminated the remaining states in the business or financial operations, clinical many commenters as an important same Census region from the remaining facilities, records, or personnel are factor in variation in medical practice, groups for which selection was pending shared by two or more practitioners. For and therefore, a critical criterion for to maximize geographic variation in the the purposes of this reporting sampling. Also, due to a variety of selection of states. In the event that this requirement, such practices do not governmental and institutional process resulted in fewer than 9 selected necessarily need to share the same requirements, the practice of medicine states (for example if none of the three physical address; for example, if is primarily a state-based activity and Middle Atlantic states—all in Group 1 practitioners practice in separate thus the use of states will reduce the and 2—were selected in the first three locations but are part of the same number of practitioners for whom we picks), the last selection(s) were made delivery system that shares business or have only partial data based on randomly from states in the remaining financial operations, clinical facilities, geographic location. In contrast, we Census region from which selections records, or personnel, all practitioners believe that practitioners often practice previously had not been made. in the delivery system would be across county lines or in more than one Practitioners located in the following included when determining if the MSA. We also believe that the state- states who meet the criteria for required practice includes at least 10 wide approach will be helpful for reporting will be required to report the practitioners. Because qualified noncompliance and education because there data discussed in this section of the physician practitioners may also furnish are state medical associations in every final rule: procedures with global periods, the state and specialty associations in many. • Florida. exception for reporting post-operative To make sure that we had states of a • Kentucky. visits applies only to practices with variety of sizes, we ranked states • Louisiana. according to the number of Medicare • Nevada. fewer than ten physicians and qualified beneficiaries in each state. We chose the • New Jersey. non-physician practitioners regardless number of Medicare beneficiaries to • North Dakota. of specialty. We are including all reflect the general need for Medicare • Ohio. practitioners and specialties in the services. We divided states into four • Oregon. count because the exception policy uses groups: The top 5 states in terms of the • Rhode Island. practice size as a proxy for the likely number of Medicare beneficiaries (group ability of the practice to meet the Exclusion for Practitioners in Small reporting requirements without undue 1); 6th through 15th largest states in Practices terms Medicare beneficiaries (group 2); administrative burden. We recognize the 16th through 25th largest states in In response to comment about the that physicians and qualified non- terms of Medicare beneficiaries (group burden of our proposed requirement physician practitioners furnish services 3); and all remaining states (26 and the concern that the burden would under a variety of practice including the District of Columbia, result in the submission of data of poor arrangements. In determining whether a group 4). The states in each group are: quality, we are exempting practitioners practitioner qualifies for the exception • Group 1—California, Florida, New who only practice in practices with based on size of the practice, all York, Pennsylvania & Texas. fewer than 10 practitioners from the physicians and qualified non-physician • Group 2—Georgia, Illinois, reporting. Based upon the comments, practitioners that furnish services as Massachusetts, Michigan, New Jersey, we believe larger practices are more part of the practice should be included. North Carolina, Ohio, Tennessee, likely to currently require practitioners This would include all practitioners, Virginia, and Washington. to track all visits and often use CPT regardless of whether they are • Group 3—Alabama, Arizona, code 99024 to do so. Moreover, larger furnishing services under an Indiana, Kentucky, Louisiana, practices are more likely to have coding employment model, a partnership Maryland, Minnesota, Missouri, and billing staff that can more easily model, or an independent contractor Wisconsin, and South Carolina. adapt to this claims-based requirement. model under which they practice as a • Group 4—Alaska, Arkansas, The combination of experience with group and share facility and other Colorado, Connecticut, District of reporting CPT code 99024 and the staff resources but continue to bill Medicare Columbia, Delaware, Hawaii, Idaho, and resource base to devote to independently instead of reassigning Iowa, Kansas, Maine, Mississippi, developing the infrastructure for such benefits. We also recognize that practice Montana, Nebraska, Nevada, New reporting will result in greater accuracy size can fluctuate over the year and Hampshire, New Mexico, North Dakota, from such practitioners. By excluding anticipate that practices will determine Oklahoma, Oregon, Rhode Island, South practitioners who only practice in their eligibility for the exception based

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on their expected staffing. Generally, practices that includes of 10 or more survey results, and collect information practitioners in short-term locum tenens practitioners in Florida, Kentucky, that is not conducive to survey-based arrangements would not be included in Louisiana, Nevada, New Jersey, North reporting. the count of practitioners. When Dakota, Ohio, Oregon, and Rhode Island Our proposed sampling approach practitioners are also providing services will be required to report on claims data would sample practitioners rather than in multiple settings, the count may be on post-operative visits furnished specific procedures or visits to adjusted to reflect the estimated during the global period of a specified streamline survey data collection and proportion of time spent in the group procedure using CPT code 99024. The minimize respondent burden. practice and other settings. specified procedures are those that are Specifically, we will use a random Although this policy excludes a furnished by more than 100 sample from a frame of practitioners significant number of practitioners, a practitioners and either are nationally who billed Medicare for more than a majority of the global procedures furnished more than 10,000 times minimum threshold of surgical furnished will be included in the annually or have more than $10 million procedures with a 10- or 90-day global reporting requirements and thus we will in annual allowed charges. The final list period (for example, 200 procedures) in have data on a majority of services. of codes subject to required reporting the most recent available prior year of Several commenters also expressed will be available on the CMS Web site. claims data. The sampling frame would concern that data from small practices Although required reporting begins for provide responses from approximately be included to have complete global procedures furnished on or after 5,000 practitioners, stratified by information. If those practicing in small July 1, 2017, we encourage all specialty, geography, and practice type. practices are motivated to report and practitioners to begin reporting for Based upon preliminary analysis, we either have the infrastructure to do so in procedures furnished on or after January believe this number of participants will place or the resources to develop such 1, 2017, if feasible. Similarly, we allow us to collect information on post- infrastructure, then, taken together, encourage those practicing in practices operative care following the full range of these attributes would minimize with fewer than 10 practitioners to CPT level-2 surgical procedure code concerns with accuracy of data from report data if they can do so. groups. For many common types of small practices. Accordingly, we are post-operative visits, we anticipate a encouraging, but not requiring, small (1) Survey of Practitioners standard deviation of the time practices to report the visits. As we We agreed with commenters on the distribution at around 9 minutes. To collect data, we will explore CY 2016 proposed rule and at the achieve a 95 percent confidence mechanisms to appropriately use the listening session that we need more intervals with a width of 2 minutes, we voluntarily submitted claims data. information than is currently provided would need 311 reported post-operative Analysis of this and other data we are on claims and that we should utilize a visits per procedure/procedure group. able to procure will allow us to assess number of different data sources and The most comprehensive approach whether the number of post-operative collection approaches to collect the data would be to sample sufficient visits varies based upon the size of needed to assess and revalue global practitioners to observe 311 post- practice. To the extent that it does and surgery services. In addition to the operative visits for each HCPCS that we do not have adequate data on claims-based reporting, we proposed to procedure, but this approach would be the practice patterns in small practices survey a large, national sample of cost- and time-prohibitive. Since post- from voluntarily submitted data and practitioners and their clinical staff in operative care following similar other sources, we will reconsider for which respondents would report procedures may involve similar future notice and comment rulemaking information about approximately 20 activities and times even if there are the exemption of practitioners in small discrete pre-operative and post- differences in the number of visits, we practices from the reporting operative visits and other global services proposed to sample differentially by requirements. like care coordination and patient specialty to maximize our ability to The claims data received from training. This sample would be estimate attributes of post-operative care practitioners in these states will provide stratified based upon specialty and for the largest range of procedures. more information about the number of geography, as well as by physician Sample sizes for each specialty will visits typically provided in post- volume (procedures billed) and practice be determined on the basis of number of operative periods than is available from setting. The proposed survey would procedures billed by the specialty and any other source. Through analysis of produce data on a large sample of pre- number of practitioners billing, this data, we hope to learn more about operative and post-operative visits and assuming a uniform distribution of what drives variations in the delivery of is being designed so that we could procedures across the year, an average post-operative care. Many of the analyze the data collected in of 2 post-operative visits by each patient characteristics that were suggested by conjunction with the claims-based data and an equal distribution of procedures commenters, such as size of practice, that we would be collecting. We expect across practitioners within a specialty. If type of practice, geographic, urban/ to obtain data from approximately 5,000 the procedure represented only 5 rural, academic, hospital based, practitioners. percent of total billed procedures for the specialty, etc., will be able to be We noted that, if our proposal was specialty, we could expect only one of evaluated using the claims data. finalized, RAND would develop and 20 visits sampled and reported by each Moreover, we hope to be able to stratify conduct this survey. RAND would also practitioner would be for the particular the data received based upon assist us in collecting and analyzing procedure, and thus we would need to comparisons to the national data for this survey and the claims- sample 311 practitioners within the characteristics so that the submitted based data. While the primary data specialty to achieve the target precision claims data can contribute to improved collection would be via a survey level on estimated post-operative visit valuation of PFS services. instrument, semi-structured interviews time. In summary, our claims-based data would be conducted and direct We propose targeting 311 reporting collection policy requires that, for observations of post-operative visits practitioners from each specialty which procedures furnished on or after July 1, would occur in a small number of pilot is the only specialty contributing at least 2017, practitioners who practice in sites to inform survey design, validate 5 percent of billings for any one

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procedure group code, defined as background for the post-operative care, looking at a targeted selection of procedures sharing a CPT level 2 including, for example: services, and using CPT code 99024 for heading. For other specialties, the target • Procedure codes(s) and date of the claims based component would will be defined by the maximum value service for procedure upon which the yield meaningful and actionable data for of 311 divided by the number of global period is based. the agency and stakeholders. specialties contributing at least 5 • Procedure place of service. Response: We agree that the survey percent for any procedure group code • Whether or not there were portion of the data collection approach for which that specialty contributes. The complications during or after the will provide useful information on level target sample size for a specialty will be procedure. and context. The survey will capped at 25 percent of the eligible • The number in sequence of the complement claims-based reporting and practitioners within the specialty. For follow-up visit (for example, the first will provide us with important example, if a specialty contributed to visit after the procedure). information on non-face-to-face two procedure group codes, one of The survey instrument will also activities and other activities that are which had four contributing specialties collect information on the visit in not reported with CPT code 99024. and the other had three contributing question including, for example: Comment: One commenter pointed • specialties, the specialty of interest Which level of visit using existing out challenges in survey response and would have a target of 104 reporting billing codes. in estimating time for visits by • practitioners (which is driven by the Specific face-to-face and non-face- aggregating practitioner time estimates procedure group code that is tied to to-face activities furnished on the day of for specific activities. three specialties). These guidelines will the visit. Response: While we have not • target at least 311 reporting practitioners The total time spent on face-to-face finalized the design of the survey for each procedure group code, and and non-face-to-face activities on the instrument, we are aware of challenges day of the visit. in collecting detailed time estimates for result in a total target sample size of • 4,872 providers. A smaller sample size Direct practice expense items used specific activities. We do not intend to would reduce the precision of estimates during the visit, for example supplies sum estimated times for specific from the survey and more importantly like surgical dressings and clinical staff activities to arrive at a total duration for risk missing important differences in time. the visit. We also recognize the post-operative care for specific Finally, the instrument will ask challenges related to survey response specialties or following different types respondents to report other prior or rates and are working with our of surgical procedures. We expect a anticipated care furnished to the patient contractor accordingly. response rate in excess of 50 percent. by the practice outside of the context of Comment: Several commenters Given this response rate (and some a post-operative visit, for example non- suggested that the survey effort should uncertainty in this response rate face-to-face services. not target all 4,200 procedure codes. estimate), we will need to approach at The survey approach will Response: The survey component of least 9,722 practitioners for our target of complement the claims data collection the data collection effort is not designed 4,872 practitioners. Should the response by collecting detailed information on to collect information on visits rate be lower than expected, we will the activities, time, intensity, and following all global procedure codes. continue to sample in waves until we resources involved in delivering global Rather, we expect the sample to be reach the target of approximately 4,872 services. The resulting visit-level survey stratified by specialty and to result in a practitioners. Non-response bias will be data would allow us to explore in detail sufficient qualitative data to address key assessed by comparing available the variation in activities, time, procedures in each specialty furnishing characteristics of non-respondents (for intensity, and resources associated with procedures with global periods. example, practice type, geography, global services within and between Comment: Some commenters believed procedure volume etc.) to those of physicians and procedures, and would that the purpose of the direct respondents. help to validate the information observation component of the data We did not propose that respondents gathered through claims. A summary of collection effort was unclear. report on the entire period of post- the work that RAND would be doing is Response: The direct observation operative care for individual patients, as available on the CMS Web site under component will consist of external a 90-day follow-up window (for downloads for the CY 2017 PFS observers capturing the activities surgeries currently with a 90-day global proposed rule with comment period at conducted in a sample of post-operative period) is too long to implement http://www.cms.gov/physicianfeesched/ visits at a small number of practices. It practically in this study setting and downloads/. is designed to provide additional would be more burdensome to The following is a summary of the context to inform future data collection practitioners. Instead, we proposed to comments that we received on our efforts and to gauge where the collect information on a range of proposal to conduct a survey of practitioner survey does or does not different post-operative services practitioners furnishing 10- and 90-day capture the full range of activities. It is resulting from surgeries furnished by global services to obtain information not a data collection activity per se. the in-sample practitioner prior to or about the face-to-face activities and After consideration of the comments, during a fixed reporting period. other activities included in post- we are finalizing our proposal to Practitioners will be asked to describe operative care. conduct a survey of practitioners to gain 20 post-operative visits furnished to Comment: Most commenters were information on post-operative activities Medicare beneficiaries or other patients generally supportive of the survey effort to supplement our claims-based data during the reporting period. The and noted that the provider survey will collection as proposed. We expect that information collected through the collect useful information on the level the survey will be in the field mid-2017. survey instrument, which will be of visits, as well as important contextual developed based upon direct detail that will not be available from the (2) Required Participation in Data observation and discussions in a small claims-based reporting. One commenter Collection number of pilot sites, will include stated that a limited approach through Using the authority we are provided contextual information to describe the surveys of physicians and practices under sections 1848(c)(8) and

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1848(c)(2)(M) of the Act, we proposed to opposed the imposition of this payment After considering the comments, we require all practitioners who furnish a consequence for failure to report, and are finalizing our proposal to require 10- or 90-day global service to submit a others stated that it was too large a participation in the claims-based claim(s) providing information on all penalty. While withholding a portion of reporting. It should be noted, however, services furnished within the relevant payment would encourage practitioners due to our modifying the requirement to global service period in the form and to report the required information, we apply only to those identified as part of manner described in this section of the did not propose to implement this the geographic sample, on selected final rule, beginning with surgical or option for CY 2017. We stated that procedures, using one code, and procedural services furnished on or after requiring physicians to report the exempting those practicing in groups January 1, 2017. We also proposed to information on claims, combined with with fewer than 10 practitioners, as require participation by practitioners the incentive to report complete discussed above, the impact of the selected for the broad-based survey information so that revaluations of requirement is significantly reduced through which we proposed to gather payment rates for global services are overall, including for the subset of additional data needed to value surgical based on accurate data, would result in practitioners who will have to report services, such as the clinical labor and compliance with the reporting under the finalized requirements. equipment involved that cannot be requirements. However, we noted that if We are not implementing the efficiently collected on claim (see we find that compliance with required statutory provision that authorizes a 5 below). claims-based reporting is not acceptable, percent withhold of payment for the Given the importance of the proposed we would consider in future rulemaking global services until claims are filed for survey effort, making sure that we get imposing up to a 5 percent payment the post-operative care, if required. We valid data is critical. By eliminating the withhold as authorized by the statute. reiterate that should we find that bias that would be associated with using Consistent with the requirements of compliance with required claims-based only data reported voluntarily, we section 1848(c)(2)(M) of the Act, should reporting limits confidence in the use of stated that we expected to get more the data collected under this the information for improving the accurate and representative data. In requirement be used to determine RVUs, accuracy of payments for the global addition to the potential bias inherent in we will disclose the information source codes, we would consider in future voluntary surveys, we expressed and discuss the use of such information rulemaking imposing up to a 5 percent concern that relying on voluntary data in such determination of relative values payment withhold as authorized by the reporting would limit the adequacy of through future notice and comment statute. the volume of data we obtain, would rulemaking. (3) Data Collection From Accountable require more effort to recruit The following is a summary of the Care Organizations (ACOs) participants, and may make it comments we received on our proposal impossible to obtain data for valuation We are particularly interested in to require reporting in the claims-based for CY 2019 as required by the statute. knowing whether physicians and Based on our previous experience survey and participation in the survey. practices affiliated with ACOs expend with requesting voluntary cooperation Comment: Many commenters objected greater time and effort in providing in data collection activity, voluntary overall to the administrative burden of post-operative global services in keeping participation poses a significant our proposal and questioned the need with their goal of improving care challenge in collection and use of data. for some of the data we were proposing coordination for their assigned Specifically, the Urban Institute’s work to collect, primarily through the claims- beneficiaries. ACOs are organizations in (under contract with us) to validate based reporting, and made many which practitioners and hospitals work RVUs by conducting direct recommendations for less burdensome voluntarily come together to provide observation of the time it took to furnish data collection to achieve our goals. high-quality and coordinated care for certain elements of services paid under Some objected to any claims-based their patients. Because such the physician fee schedule provides reporting at this time. A few organizations share in the savings evidence of this challenge. (See https:// recommended a different approach that realized by Medicare, their incentive is www.cms.gov/Medicare/Medicare-Fee- involved collecting information from a to minimize post-operative visits while for-Service-Payment/ small number of practices that agree to maintaining high quality post-operative PhysicianFeeSched/Downloads/RVUs- participate and that we pay such care for patients. In addition, we believe Validation-Urban-Interim-Report.pdf for practices for participation. However, that such organizations offer us the an interim report that describes none recommended that we go forward opportunity to gain more in-depth challenges in securing participation in with data collection on a totally information about delivery of surgical voluntary data collection.) Similarly, we voluntary basis. Some indicated concern services. routinely request invoices on equipment that practitioners would not provide We proposed to collect data on the and supplies that are used in furnishing required information. activities and resources involved in PFS services and often receive no more Response: We appreciate the many delivering services in and around than one invoice. These experiences ideas for how to improve our data surgical events in the ACO context by support the idea that mandatory collection effort, particularly those that surveying a small number of ACOs participation in data collection activities provided information on how to collect (Pioneer and Next Generation ACOs). is essential if we are to collect valid and the information that we need while Similar to the approach of the more unbiased data. imposing a lower administrative burden general practitioner survey, this effort Section 1848(a)(9) of the Act on practitioners. would begin with an initial phase of authorizes us, through rulemaking, to Comment: A few commenters primary data collection using a range of withhold payment of up to 5 percent of supported our not proposing to methodologies in a small number of the payment for services on which the implement the 5 percent withhold until ACOs; development, piloting, and practitioner is required to report under claims on the post-operative care were validation of an additional survey section 1848(c)(8)(B)(i) of the Act until submitted. module specific to ACOs. A survey of the practitioner has completed the Response: We appreciate the support practitioners participating in required reporting. Some commenters of commenters. approximately 4 to 6 ACOs using the

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survey instrument along with the would be used in valuing services. What over multiple days or months. Outside additional ACO-specific module will be is clear is that the claims-based data of these services, work RVUs are used to collect data from on pre- and would provide information parallel to estimated per patient encounter (or in post-operative visits. the kinds of claims-data used in other cases over longer periods of time The following is summary of the developing RVUs for other PFS services for non-face-to-face work). Therefore, comments we received about our and that by collecting these data, we the outer limit of any misvaluation proposal for data ACO data collection. would know far more than we do now between the estimated typical and the Comment: Several commenters about how post-operative care is actual is the overall value for a single supported a separate survey of delivered and gain insight to support face-to-face service. Under the global practitioners participating in ACOs. One appropriate packaging and valuation. packages, potential misvaluations can commenter agreed with CMS that this We would include any revaluation range from the difference between the data collection effort may provide a proposals based on these data in estimated typical services for a full unique and useful perspective on the subsequent notice and comment global period and the actual services matter at hand. Several commenters rulemaking. furnished for a full global period for a indicated that there are likely Even though we did not make a given patient. We are not finalizing any differences in pre- and post-operative proposal regarding how future re- provisions regarding valuation of global care between practitioners who do valuations would use the data collected surgical services. Instead, such issues participate in ACOs and those that do under these proposals, we received will be addressed in future rulemaking not. One commenter cautioned against several comments on such revaluations. after we collect data and analyze data. extrapolating information gathered from The following is summary of the ACOs to value global surgery services comments we received regarding use of E. Improving Payment Accuracy for that are provided outside of the ACO the data we obtain through this three- Primary Care, Care Management and setting because ACOs are structured pronged data collection activity in Patient-Centered Services differently than other practice settings future re-valuations. 1. Overview and data from ACOs may, therefore, be Comment: Some commenters stated skewed [and] that ACO participants that the RUC process worked well to In recent years, we have undertaken typically are larger practices and thus value services and should continue to ongoing efforts to support primary care would underrepresent smaller or solo be used to value these and other and patient-centered care management practitioners. services. Some of these objected to any within the PFS as part of HHS’ broader Response: We agree that ACOs may be claims-based data collection for a efforts to achieve better care, smarter structured differently than other variety of reasons including that it was spending and healthier people through practice settings and that these unlikely to provide valid and reliable delivery system reform. We have differences may contribute to variations data, that the RUC process worked well recognized the need to improve in the provision of outpatient care. By and should continue to be used, and the payment accuracy for these services separately surveying ACOs we will be that since other codes would not be over several years, especially beginning able to investigate whether there are valued on the basis of similar data use in the CY 2012 PFS proposed rule (76 differences in pre- and post-operative of this data would harm the fee FR 42793) and continuing in each care in ACO settings compared to non- schedule’s relativity. Some suggested subsequent year of rulemaking. In the ACO settings. that we use the data obtained here to CY 2012 proposed rule, we After consideration of the comments identify misvalued codes and refer them acknowledged the limitations of the received, we are finalizing our proposal to the RUC for further evaluation under current code set that describes for data collection in ACOs. We the usual process. Some commenters evaluation and management (E/M) recognize and will continue to consider suggested that we not collect any data services within the PFS. For example, the concerns raised by commenters as until we could describe how it would be E/M services represent a high we implement this project. used. proportion of PFS expenditures, but Response: We believe that the have not been recently revalued to (6) Re-Valuation Based Upon Collected Congress enacted the two data Data account for significant changes in the collection provisions included in the disease burden of the Medicare patient We recognize that the some of the Act to further the accuracy of PFS rates population and changes in health care data collection activities being by having additional data available to practice that are underway to meet the undertaken vary from how information the RUC as it makes recommendations current population’s health care needs. is currently gathered to support PFS to us and to us to inform our evaluation These trends in the Medicare valuations for global surgery services. of those recommendations. We do not population and health care practice However, we believe the proposed believe this data collection was have been widely recognized in the claims-based data collection is generally intended to replace the RUC or the provider community and by health consistent with how claims data is processes that have been established services researchers and policymakers reported for other kinds of services paid over the last two decades for valuing alike.1 We believe the focus of the under the PFS. We believe that the physician services. We agree with authority and requirements included in commenters that one way the data might 1 See, for example, http:// the statute through the MACRA and be used is to identify potentially content.healthaffairs.org/content/25/5/w378.full; PAMA were intended to expand and misvalued codes for the RUC to http://www.commonwealthfund.org/publications/ enhance data that might be available to evaluate. However, we also stress that issue-briefs/2008/feb/how-disease-burden- influences-medication-patterns-for-medicare- enhance the accuracy of PFS payments. we do not agree that the use of claims beneficiaries—implications-for-polic; http:// In the proposed rule, we indicated that data to value services within global www.hhs.gov/ash/about-ash/multiple-chronic- because these are new approaches to surgery packages would be inconsistent conditions/index.html; http://www.nejm.org/doi/ collecting data and in an area—global with the valuation of other PFS services. full/10.1056/NEJMp1600999#t=article; https:// www.pcpcc.org/about; https://www.cms.gov/ surgery—where very little data has On the contrary, very few other PFS Medicare/Quality-Initiatives-Patient-Assessment- previously been collected, we cannot services include estimated work RVUs Instruments/Value-Based-Programs/MACRA-MIPS- describe exactly how this information based on face-to-face patient encounters and-APMs/MACRA-MIPS-and-APMs.html.

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health care system has shifted to therefore, their revenue from Medicare care model (CoCM)), and between delivery system reforms, such as relative to other specialties, particularly primary care physicians and other (non- patient-centered medical homes, those that spend most of their time mental health) specialists; and (3) clinical practice improvement, and providing E/M services. (MedPAC assessing whether current PFS payment increased investment in primary and March 2015 Report to the Congress, for CCM services is adequate and comprehensive care management/ available at http://www.medpac.gov/- whether we should reduce the coordination services for chronic and documents-/reports). We agree with this administrative burden associated with other conditions. This shift requires analysis, and we recognize that the furnishing and billing these services. more centralized management of patient current set of E/M codes limits We received substantial feedback on needs and extensive care coordination Medicare’s ability under the PFS to this comment solicitation, which we among practitioners and providers, appropriately recognize the relative summarized in the CY 2017 PFS often on a non-face-to-face basis across resource costs of primary care, care proposed rule and used to develop the an extended period of time. In contrast, management/coordination and cognitive following coding and payment the current CPT code set is designed services relative to specialized proposals for CY 2017 (81 FR 46200 with an overall orientation to pay for procedures and diagnostic tests. through 46215, and 46263 through discrete services and procedural care as In recent years, we have been engaged 46265): opposed to ongoing primary care, care in an ongoing incremental effort to • Separate payment for existing codes management and coordination, and update and improve the relative value of describing prolonged E/M services cognitive services. It includes thousands primary care, care management/ without direct patient contact by the of separately paid, individual codes, coordination, and cognitive services physician (or other billing practitioner), most of which describe highly within the PFS by identifying gaps in and increased payment for prolonged specialized procedures and diagnostic appropriate payment and coding. These E/M services with direct patient contact tests, while there are relatively few efforts include changes in payment and by the physician (or other billing codes that describe care management coding for a broad range of PFS services. practitioner) adopting the RUC- and cognitive services. The term This effort is particularly vital in the recommended values.3 ‘‘cognitive services’’ refers to the type of context of the forthcoming transition to • New coding and payment work that is usually classified and the Quality Payment Program that mechanisms for behavioral health described under the current code set for includes the Merit-Based Incentive integration (BHI) services including E/M services, such as the critical Payment System (MIPS) and Alternative substance use disorder treatment, thinking involved in data gathering and Payment Models (APMs) incentives specifically three codes to describe analysis, planning, management, under the Medicare Access and CHIP services furnished as part of the decision-making, and exercising Reauthorization Act of 2015 (MACRA) psychiatric CoCM and one code to judgment in ambiguous or uncertain (Pub. L. 114–10, enacted April 16, address other BHI care models. situations.2 It is often used to describe 2015), since MIPS and many APMs will • Separate payment for complex CCM PFS services that are not procedural or adopt and build on PFS coding, RVUs services, reduced administrative burden strictly diagnostic in nature. Further, in and PFS payment as their foundation. for CCM, and an add-on code to the visit the past, we have not recognized as In CY 2013, we began by focusing on during which CCM is initiated (the CCM separately payable many existing CPT post-discharge care management and initiating visit) to reflect the work of the codes that describe care management transition of beneficiaries back into the billing practitioner in assessing the and cognitive services, viewing them as community, establishing new codes to beneficiary and establishing the CCM pay separately for transitional care bundled and paid as part of other care plan. services including the broadly drawn E/ management (TCM) services. Next we • A new code for cognition and finalized new coding and separate M codes that describe face-to-face visits functional assessment and care payment beginning in CY 2015 for billed by physicians and practitioners in planning, for treatment of cognitive chronic care management (CCM) all specialties. impairment. services provided by clinical staff. In the This has resulted in minimal service • An adjustment to payment for CY 2016 PFS proposed rule (80 FR variation for ongoing primary care, care routine visits furnished to beneficiaries 41708 through 41711), we solicited management and coordination, and for whom the use of specialized public comments on three additional cognitive services relative to other PFS mobility-assistive technology (such as policy areas of consideration: (1) services, and in potential misvaluation adjustable height chairs or tables, Improving payment for the professional of E/M services under the PFS (76 FR patient lifts, and adjustable padded leg work of care management services 42793). Some stakeholders believe that supports) is medically necessary. through coding that would more there is substantial misvaluation of We noted that the development of accurately describe and value the work physician work within the PFS, and that coding for these and other kinds of of primary care and other cognitive the current service codes fail to capture services across the PFS is typically an specialties for complex patients (for the range and intensity of iterative process that responds to nonprocedural physician activities (E/M example, monthly timed services including care coordination, patient/ changes in medical practice and may be services) and the ‘‘cognitive’’ work of best refined over several years, with PFS certain specialties (http:// caregiver education, medication management, assessment and rulemaking and the development of CPT www.nejm.org/doi/full/10.1056/ codes as important parts of that process. NEJMp1600999#t=article). integration of data, care planning); (2) establishing separate payment for We noted with interest that the CPT Recognizing the inverse for specialties Editorial Panel and AMA/RUC that furnish other kinds of services, collaborative care, particularly, how we might better value and pay for robust restructured the former Chronic Care MedPAC has noted that the PFS allows Coordination Workgroup to establish a some specialties to more easily increase inter-professional consultation between primary care physicians and the volume of services they provide, and 3 ‘‘Without direct patient contact’’ and ‘‘with psychiatrists (developing codes to direct patient contact’’ in this sentence are the 2 http://www.nejm.org/doi/full/10.1056/ describe and provide payment for the terms used in the CPT code descriptor or prefatory NEJMp1600999#t=article. evidence-based psychiatric collaborative language for these prolonged E/M services.

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new Emerging CPT and RUC Issues descriptions included for G0502, G0503, interviewing, and other focused Workgroup that we hope will continue and G0504 are from Current Procedural treatment strategies; to consider the issues raised in this Terminology (CPT®) Copyright 2016 ++ Monitoring of patient outcomes section of our CY 2017 proposed rule. American Medical Association (and we using validated rating scales; and At the time of publication of the understand from CPT that they will be relapse prevention planning with proposed rule, we were aware that CPT effective as part of CPT codes January 1, patients as they achieve remission of had approved a code to describe 2018). All rights reserved): symptoms and/or other treatment goals assessment and care planning for • G0502: Initial psychiatric and are prepared for discharge from treatment of cognitive impairment; collaborative care management, first 70 active treatment. • however, it would not be ready in time minutes in the first calendar month of G0504: Initial or subsequent for valuation in CY 2017. Therefore, we behavioral health care manager psychiatric collaborative care proposed to make payment using a G- activities, in consultation with a management, each additional 30 code (G0505 4) for this service in CY psychiatric consultant, and directed by minutes in a calendar month of 2017. We were also aware that CPT had the treating physician or other qualified behavioral health care manager approved three codes that describe health care professional, with the activities, in consultation with a services furnished consistent with the following required elements: psychiatric consultant, and directed by psychiatric CoCM, but that they would ++ Outreach to and engagement in the treating physician or other qualified also not be ready in time for valuation treatment of a patient directed by the health care professional (List separately in CY 2017. We discuss these services treating physician or other qualified in addition to code for primary in more detail in the next section of this health care professional; procedure) (Use G0504 in conjunction final rule. ++ Initial assessment of the patient, with G0502, G0503). • G0507: Care management services To facilitate separate payment for including administration of validated for behavioral health conditions, at least these services furnished to Medicare rating scales, with the development of 20 minutes of clinical staff time, beneficiaries during CY 2017, we an individualized treatment plan; directed by a physician or other proposed to make payment through the ++ Review by the psychiatric use of three G-codes (G0502, G0503, and qualified health care professional time, consultant with modifications of the per calendar month. G0504—see below) that parallel the new plan if recommended; CPT codes, as well as a fourth G-code • G0505: Cognition and functional ++ Entering patient in a registry and assessment using standardized (G0507—see below) to describe services tracking patient follow-up and progress furnished using other models of BHI in instruments with development of using the registry, with appropriate the primary care setting. We intended recorded care plan for the patient with documentation, and participation in for these to be temporary codes and cognitive impairment, history obtained weekly caseload consultation with the would consider whether to adopt and from patient and/or caregiver, by the psychiatric consultant; and establish values for the new CPT codes physician or other qualified health care ++ Provision of brief interventions under our standard process, potentially professional in office or other outpatient using evidence-based techniques such for CY 2018. We anticipated continuing setting or home or domiciliary or rest as behavioral activation, motivational the multi-year process of implementing home. initiatives designed to improve payment interviewing, and other focused • G0506: Comprehensive assessment treatment strategies. of and care planning by the physician or for, and recognize long-term investment • in, primary care, care management and G0503: Subsequent psychiatric other qualified health care professional cognitive services, and patient-centered collaborative care management, first 60 for patients requiring chronic care services. While we recognized that there minutes in a subsequent month of management services, including may be some overlap in the patient behavioral health care manager assessment during the provision of a populations for the proposed new activities, in consultation with a face-to-face service (billed separately codes, we noted that time spent by a psychiatric consultant, and directed by from monthly care management practitioner or clinical staff could not be the treating physician or other qualified services) (Add-on code, list separately counted more than once for any code (or health care professional, with the in addition to primary service). • assigned to more than one patient), following required elements: G0501: Resource-intensive services consistent with PFS coding ++ Tracking patient follow-up and for patients for whom the use of conventions. We expressed continued progress using the registry, with specialized mobility-assistive consideration of additional codes for appropriate documentation; technology (such as adjustable height CCM services that would describe the ++ Participation in weekly caseload chairs or tables, patient lifts, and time of the physician or other billing consultation with the psychiatric adjustable padded leg supports) is practitioner. We also expressed interest consultant; medically necessary and used during in whether there should be changes ++ Ongoing collaboration with and the provision of an office/outpatient under the PFS to reflect additional coordination of the patient’s mental evaluation and management visit (Add- models of inter-professional health care with the treating physician on code, list separately in addition to collaboration for health conditions, in or other qualified health care primary procedure). addition to those we proposed for BHI. professional and any other treating Regarding the majority of these We proposed to pay under the PFS for mental health providers; proposals, the public comments were services described by new coding as ++ Additional review of progress and broadly supportive, some viewing our follows (please note that the recommendations for changes in proposals as a temporary solution to an treatment, as indicated, including underlying need to revalue E/M 4 We note that we used placeholder codes medications, based on services, especially outpatient E/M. (GPPP1, GPPP2, GPPP3, GPPPX, GPPP6, GPPP7, recommendations provided by the Several commenters recommended that and GDDD1) in the proposed rule. In order to avoid psychiatric consultant; CMS utilize the global surgery data confusion, we have replaced those codes with those collection effort or another major that have been finalized as part of the 2017 HCPCS ++ Provision of brief interventions set, even when describing the language in the using evidence-based techniques such research initiative to distinguish and proposed rule. as behavioral activation, motivational revalue different kinds of E/M work.

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The commenters made billing practitioner) and have a planning for patients requiring CCM recommendations about the scope and relatively high time threshold (the time services). We also solicited comment definition of the proposed services, counted must be an hour or more regarding how distinctions could be what types of individuals should be able beyond the usual service time for the made between time associated with to provide them, and potential primary or ‘‘companion’’ E/M code that prolonged services and the time alignment and overlap. The commenters is also billed). They are not reported for bundled into other E/M services, agreed with the need to increase the time spent in care plan oversight particularly pre- and post-service times, relative value of primary care, care services or other non-face-to-face which would continue to be bundled management and other cognitive care services that have more specific codes with the other E/M service codes. For all under the PFS and minimize and no upper time limit in the CPT code of these services, we expressed concern administrative burden for such services, set. We believed this made these codes that there would potentially be program while ensuring value to the program and sufficiently distinct from the other integrity risks as the same or similar beneficiaries. The public comments codes we proposed for CY 2017 as part non-face-to-face activities could be raise or inform a number of issues of our primary care/cognitive care/care undertaken to meet the billing around how to define and pay for care management initiative described in this requirements for a number of codes. We that is collaborative, integrative or section of our final rule. Accordingly, solicited public comment to help us continuous, and we discuss the we proposed to recognize CPT codes identify the full extent of program comments in greater detail below. 99358 and 99359 for separate payment integrity considerations, as well as under the PFS beginning in CY 2017. 2. Non-Face-to-Face Prolonged options for mitigating program integrity We noted that time could not be Evaluation & Management (E/M) risks. counted more than once towards the Services Comment: Many commenters provision of CPT codes 99358 or 99359 recommended that we adopt the CPT In public comments on the CY 2016 and any other PFS service. We PFS proposed rule, many commenters coding provision for CPT codes 99358 addressed their valuation in the and 99359 that allows the prolonged recommended that CMS should valuation section of the CY 2017 establish separate payment for non-face- services to be provided on a different proposed rule. day than the companion E/M code. At to-face prolonged E/M service codes that Through a drafting error, we stated in the same time, several commenters we currently consider to be ‘‘bundled’’ the proposed rule that we would require indicated that they request changes to under the PFS (CPT codes 99358, these services to be furnished on the 99359). The CPT descriptors are: same day by the same physician or other the codes through the established • CPT code 99358 (Prolonged billing practitioner as the companion processes of the CPT Editorial Panel. evaluation and management service E/M code. We intended to propose For example, some commenters before and/or after direct patient care, conformity with CPT guidance that suggested that CPT codes 99358 and first hour); and requires that time counted towards the 99359 should be revised so that they • CPT code 99359 (Prolonged codes describe services furnished have a limited (calendar month) service evaluation and management service during a single day directly related to a period or measure shorter time before and/or after direct patient care, discrete face-to-face service that may be increments (15 minutes). Some each additional 30 minutes (List provided on a different day, provided commenters recommended that a given separately in addition to code for that the services are directly related to physician should not be allowed to prolonged service). those furnished in a face-to-face visit. report CPT codes 99358 and 99359 for Commenters believed that separate We also solicited public comment on the same beneficiary during the same payment for these existing CPT codes our interpretation of existing CPT time he or she reported CCM, TCM, or would provide a means for physicians guidance governing concurrent billing G0506. These commenters stated that and other billing practitioners to receive or overlap of CPT codes 99358 and CCM, TCM, and proposed G0506 payment that more appropriately 99359 with complex CCM services (CPT encompass non-face-to-face care accounts for time that they spend codes 99487 and 99489) and TCM provided to the beneficiary during a providing non-face-to-face care. We services (CPT codes 99495 and 99496). given period of time that would be agreed that these codes would provide Specifically CPT provides, ‘‘Do not duplicated if the physician is also a means to recognize the additional report 99358, 99359 during the same allowed to report CPT codes 99358 and resource costs of physicians and other month with 99487–99489. Do not report 99359 during the same time period. billing practitioners, when they spend 99358, 99359 when performed during Other commenters stated that it would an extraordinary amount of time outside the service time of codes 99495 or be unusual for G0506 and non-face-to- of an E/M visit performing work that is 99496.’’ Complex CCM services and face prolonged services (CPT codes related to that visit and does not involve TCM services are similar to the non- 99358 and 99359) to be reported for direct patient contact (such as extensive face-to-face prolonged services in that services on the same day, but that both medical record review, review of they include substantial non-face-to-face should be allowed if time thresholds are diagnostic test results or other ongoing work by the billing physician or other met. To facilitate determination of care management work). We also practitioner. The TCM and CCM codes whether time thresholds are met for believed that doing so in the context of similarly focus on a broader episode of various potential code combinations, the ongoing changes in health care patient care that extends beyond a some commenters recommended that practice to meet the current single day, although they have a CMS establish a time for G0506 and population’s health care needs would be monthly service period and the publish typical times for the companion beneficial for Medicare beneficiaries prolonged service codes do not. We codes to the prolonged service codes. and consistent with our overarching sought public input on the intersection This would enable practitioners to goals related to patient-centered care. of the non-face-to-face prolonged service determine when they have exceeded These non-face-to-face prolonged codes with CCM and TCM services, and ‘‘usual’’ or average times for E/M service codes are broadly described with the proposed add-on code to the services and may bill prolonged (although they include only time spent CCM initiating visit G0506 services. Some commenters personally by the physician or other (Comprehensive assessment of and care recommended that CMS provide tables

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showing times for E/M visits, CCM, services and many other codes because Regulation-Notices.html. We note that G0506 and prolonged services with the included services, service periods while these typical times are not specific clinical examples for and timeframes are not aligned. For required to bill the displayed codes, we concurrent billing. example, most services paid under the would expect that only time spent in Some commenters believed there PFS are valued based on assumptions excess of these times would be reported might be some overlap between the regarding the typical pre-service, intra- under a non-face-to-face prolonged proposed non-face-to-face prolonged service and post-service time, but do not service code. service codes and the post-service work have required thresholds for time spent. Based on our analysis of comments, of G0505 (Cognition and functional It is difficult to distinguish the times we do not believe there is significant assessment by the physician or other associated with these services from the overlap between CPT codes 99358 and qualified health care professional in times for codes that include time 99359 and the CCM codes (CPT 99487, office or other outpatient). Some requirements in their descriptor. It is 99489, 99490) or our finalized BHI commenters believed there is a also difficult to distinguish the time and service codes (G0502, G0503, G0504, discrepancy between our proposal to other work included in codes that G0507 discussed below). The work of allow G0505 to be a companion code to generally describe services furnished the billing practitioner in the provision prolonged services, and CPT’s intent during one day (prolonged services and of non-complex CCM and the BHI that G0505 should only be billed on the E/M visits) with codes that describe services is related to the direction of same day as another E/M visit if they are time and work over substantially ongoing care management and unrelated. different service periods (such as the coordination activities of other MedPAC commented that the calendar month services like CCM or individuals, compared to the work of companion E/M codes should be BHI services) or add-on codes with no 99358 and 99359 which is described as revalued instead of providing separate pre or post-service time (such as G0506). personally performed and directly payment for prolonged services In addition, because portions of many related to a face-to-face service. On that associated with the companion codes. services are likely describing work that basis, we do not believe that there is However, if we finalize as proposed, is furnished ‘‘incident to’’ a physician’s significant overlap in the description of MedPAC recommended that we clarify or practitioner’s services, the time and services or the valuation. what situations the prolonged codes are effort of the billing practitioner may not The potential intersection of CPT appropriate for, beyond average times. be the only relevant time and effort to codes 99358 and 99359 with the Another commenter recommended an consider. Moreover, the comments complex CCM codes is harder to assess alternative policy instead of the non- reflect a desire and intent on the part of because complex CCM explicitly face-to-face prolonged service codes, stakeholders to alter the prolonged includes medical decision-making of moderate to high complexity by the namely several modifiers and add-on service codes in the near future, which codes to E/M services, associated with billing practitioner, which is not would, in turn, alter their intersection increased work RVUs. A typical time for performed by clinical staff. The complex with the codes proposed in this section the primary service would not need to CCM codes, however, only measure or of our 2017 rule and many other codes. be established. This coding schema count the time of clinical staff. The public comments also reflect a lack would focus on visits actively treating Similarly, TCM includes moderate to of consensus regarding appropriate patients with four or more chronic high complexity medical decision- medical practice and reporting patterns conditions; patients with three or more making during the service period as for prolonged services in relation to the chronic problems introducing an acute well as a level 4 or 5 face-to-face visit, services described by the CCM, TCM, problem during their visit; unexpected even though clinical staff may perform proposed G0505 and proposed G0506 abnormal studies; and electronic a number of other aspects of the service. communication after visits with the codes. For CY 2017, for administrative patient, lab, and other clinicians. One Having considered this feedback, we simplicity, we are adopting the CPT commenter drew a distinction between have decided to finalize our proposal for provision (and finalizing as proposed) prolonged service work and care separate payment of the non-face-to-face that complex CCM cannot be reported management services, where care prolonged service codes (CPT 99358, during the same month as non-face-to- management does not include extensive 99359) and adopt the CPT code face prolonged services, CPT codes review of medical records, review of descriptors and prefatory language for 99358 and 99359 (by a single diagnostic tests and further discussion reporting these services. We stress that practitioner). Similarly, we are adopting with a caregiver. we intend these codes to be used to the CPT provision that non-face-to-face Response: We appreciate the report extended non-face-to-face time prolonged services, CPT codes 99358 comments. First, we had intended to that is spent by the billing physician or and 99359 may not be reported when propose to adopt the CPT coding other practitioner (not clinical staff) that performed during the service time of provision for CPT codes 99358 and is not within the scope of practice of TCM (CPT codes 99495 and 99496) (by 99359 that allows the prolonged time to clinical staff, and that is not adequately a single practitioner). We interpret the be provided on a different day than the identified or valued under existing CPT provision to mean that CPT codes companion E/M code, along with the codes or the 2017 finalized new codes. 99358 and 99359 cannot be reported rest of the CPT prefatory language for We appreciate the commenters’ during the TCM 30-day service period, these codes. Our final policy will adopt suggestion to display the typical times by the same practitioner who is the CPT guidance that allows the associated with relevant services. We reporting the TCM. prolonged time to be reported for time have posted a file that notes the times Regarding potential intersection of on a different day than the companion assumed to be typical for purposes of CPT codes 99358 and 99359 with E/M code, along with the rest of the CPT PFS rate-setting. That file is available on proposed G0505 (Cognition and prefatory language for CPT codes 99358 our Web site under downloads for the functional assessment by the physician and 99359. CY 2017 PFS final rule at http:// or other qualified health care Second, the public comments www.cms.gov/Medicare/Medicare-Fee- professional in office or other elucidate that it is difficult to assess for-Service-Payment/ outpatient), we are finalizing our potential overlap between prolonged PhysicianFeeSched/PFS-Federal- proposal that G0505 be designated as a

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companion or ‘‘base’’ E/M code to non- management for Medicare beneficiaries collaborative care model has been tested face-to-face prolonged services (CPT with behavioral health conditions often and documented in medical literature, codes 99358 and 99359) (see section requires extensive discussion, in the CY 2016 proposed rule we II.E.5 for a detailed discussion of information-sharing and planning expressed particular interest in how G0505). That is, for CY 2017 CPT codes between a primary care physician and a coding used to describe PFS services 99358 and 99359 may be reported with specialist. In CY 2016 rulemaking, we might facilitate appropriate valuation of G0505 as the associated companion described that in recent years, many the services furnished under this model. code, whether furnished on the same randomized controlled trials have We solicited public comments to assist day or a different day. We believe CPT established an evidence base for an us in considering refinements to coding intended the code on which G0505 is approach to caring for patients with and payment to address this model in modeled to function like a specific E/M behavioral health conditions called the particular relative to current coding and service, and that while the specificity of psychiatric Collaborative Care Model payment policies, as well as information the service explicitly includes care (CoCM). We sought information to assist related to various requirements and planning unique to the needs of patients us in considering refinements to coding aspects of these services. with particular conditions, there may and payment to address this model in After consideration of the comments, well be circumstances where the pre- or particular. The psychiatric CoCM is one we proposed in the CY 2017 PFS post-time for a particular beneficiary of many models for behavioral health proposed rule to begin making separate may be prolonged. In their current form, integration or BHI, a term that refers payment for services furnished using the non-face-to-face prolonged service broadly to collaborative care that the psychiatric CoCM, beginning codes exist for the purpose of providing integrates behavioral health services January 1, 2017. We were aware that the additional payment to account for the principally with primary care, but that CPT Editorial Panel, recognizing the biller’s additional time related to E/M may also integrate behavioral health need for new coding for services under visits. Therefore, we believe the non- care with inpatient and other clinical this model of care, had approved three face-to-face prolonged service codes care. BHI is a team-based approach to codes to describe the psychiatric should be reportable when related to E/ care that focuses on integrative collaborative care that is consistent with M services, including those such as treatment of patients with medical and this model, but the codes would not be G0505 that describe more specific E/M mental or behavioral health conditions. ready in time for valuation in CY 2017. work. We look forward to continued In the CY 2017 proposed rule (81 FR Current CPT coding does not accurately feedback on this issue, including 46203 through 46205), we proposed four describe or facilitate appropriate through potential revisions to CPT new G-codes for BHI services: Three payment for the treatment of Medicare guidance. describing the psychiatric CoCM beneficiaries under this model of care. Regarding intersection of CPT codes specifically, and one generally For example, under current Medicare 99358 and 99359 with G0506, we note describing related models of care. payment policy, there is no payment that G0506 is already an add-on code to made specifically for regular monitoring another E/M service (the CCM initiating a. Psychiatric Collaborative Care Model of patients using validated clinical visit, which can be the AWV/IPPE or a (CoCM) rating scales or for regular psychiatric qualifying face-to-face E/M visit). We A specific model for BHI, psychiatric caseload review and consultation that are providing in section II.E.4.a that at CoCM typically is provided by a does not involve face-to-face contact this time (beginning in CY 2017), G0506 primary care team consisting of a with the patient. We believed that these will be a code that is only billable one primary care provider and a care resources are directly involved in time, at the outset of CCM services. We manager who works in collaboration furnishing ongoing care management agree with commenters that it would be with a psychiatric consultant, such as a services to specific patients with unusual for physicians to spend enough psychiatrist. Care is directed by the specific needs, but they are not time with a given beneficiary on a given primary care team and includes appropriately recognized under current day to warrant reporting all three codes structured care management with coding and payment mechanisms. (the initiating visit code, G0506, and a regular assessments of clinical status Because PFS valuation is based on the prolonged service code). We also believe using validated tools and modification relative resource costs of the PFS that a simpler approach is preferable at of treatment as appropriate. The services furnished to Medicare this time (two related codes for CCM psychiatric consultant provides regular beneficiaries, we believed that initiation, instead of possibly three). consultations to the primary care team appropriate coding for these services for Therefore our final policy for CY 2017 to review the clinical status and care of CY 2017 will facilitate accurate payment is that prolonged services (whether face- patients and to make recommendations. for these and other PFS services. to-face or non-face-to-face) cannot be As we previously noted, several Therefore, we proposed separate reported in addition to G0506 in resources have been published that payment for services under the association with a companion E/M code describe the psychiatric CoCM in greater psychiatric CoCM using three new G- that also qualifies as the CCM initiating detail and assess the impact of the codes, as detailed below: G0502, G0503, visit. In association with the CCM model, including pieces from the and G0504, which would parallel the initiating visit, a billing practitioner University of Washington (http:// CPT codes that are being created to may choose to report either prolonged aims.uw.edu/), the Institute for Clinical report these services. services or G0506 (if requirements to and Economic Review (http://icer- The proposed code descriptors were bill both prolonged services and G0506 review.org/announcements/icer-report- as follows (from Current Procedural are met), but cannot report both a presents-evidence-based-guidance-to- Terminology (CPT®) Copyright 2016 prolonged service code and G0506. support-integration-of-behavioral- American Medical Association (and we health-into-primary-care/), and the understand from CPT that they will be 3. Establishing Separate Payment for Cochrane Collaboration (http:// effective as part of CPT codes January 1, Behavioral Health Integration (BHI) www.cochrane.org/CD006525/ 2018). All rights reserved): In the CY 2016 PFS final rule with DEPRESSN_collaborative-care- • G0502: Initial psychiatric comment period (80 FR 70920), we forpeople-with-depression-and-anxiety). collaborative care management, first 70 stated that we believe the care and Because this particular kind of minutes in the first calendar month of

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behavioral health care manager management, each additional 30 psychiatric care provider for ongoing activities, in consultation with a minutes in a calendar month of treatment; or psychiatric consultant, and directed by behavioral health care manager • Lack of continued engagement with the treating physician or other qualified activities, in consultation with a no psychiatric collaborative care health care professional, with the psychiatric consultant, and directed by management services provided over a following required elements: the treating physician or other qualified consecutive 6-month calendar period ++ Outreach to and engagement in health care professional (List separately (break in episode). treatment of a patient directed by the in addition to code for primary A new episode of care would start after treating physician or other qualified procedure) (Use G0504 in conjunction a break in episode of 6 calendar months health care professional; with G0502, G0503). or more. ++ Initial assessment of the patient, We stated that we intend these to be The treating physician or other including administration of validated temporary codes and would consider qualified health care professional would rating scales, with the development of whether to adopt and establish values direct the behavioral health care an individualized treatment plan; for the associated new CPT codes under manager and continue to oversee the ++ Review by the psychiatric our standard process once those codes beneficiary’s care, including prescribing consultant with modifications of the are active. medications, providing treatments for plan if recommended; We proposed that these services medical conditions, and making ++ Entering patient in a registry and would be furnished under the direction referrals to specialty care when needed. tracking patient follow-up and progress of a treating physician or other qualified Medically necessary E/M and other using the registry, with appropriate health care professional during a services could be reported separately by documentation, and participation in calendar month. These services would the treating physician or other qualified weekly caseload consultation with the be furnished when a patient has a health care professional, or other psychiatric consultant; and diagnosed psychiatric disorder that physicians or practitioners, during the ++ Provision of brief interventions requires a behavioral health care same calendar month. Time spent by the using evidence-based techniques such assessment; establishing, implementing, treating physician or other qualified as behavioral activation, motivational revising, or monitoring a care plan; and health care professional on activities for interviewing, and other focused provision of brief interventions. The services reported separately could not treatment strategies. diagnosis could be either pre-existing or • be included in the services reported G0503: Subsequent psychiatric made by the billing practitioner. These using G0502, G0503, and G0504. We collaborative care management, first 60 services would be reported by the proposed that the behavioral health care minutes in a subsequent month of treating physician or other qualified manager would be a member of the health care professional and include the behavioral health care manager treating physician or other qualified services of the treating physician or activities, in consultation with a health care professional’s clinical staff other qualified health care professional, psychiatric consultant, and directed by with formal education or specialized the behavioral health care manager (see the treating physician or other qualified training in behavioral health (which description below) who would furnish health care professional, with the could include a range of disciplines, for services incident to services of the following required elements: example, social work, nursing, and treating physician or other qualified ++ Tracking patient follow-up and psychology) who provides care health care professional, and the progress using the registry, with management services, as well as an psychiatric consultant (see description appropriate documentation; assessment of needs, including the ++ Participation in weekly caseload below) whose consultative services administration of validated rating consultation with the psychiatric would be furnished incident to services scales,5 the development of a care plan, consultant; of the treating physician or other ++ Ongoing collaboration with and qualified health care professional. We provision of brief interventions, ongoing coordination of the patient’s mental proposed that beneficiaries who are collaboration with the treating appropriate candidates for care reported physician or other qualified health care health care with the treating physician 6 or other qualified health care using the psychiatric CoCM codes could professional, maintenance of a registry, professional and any other treating have newly diagnosed conditions, need all in consultation with a psychiatric mental health providers; help in engaging in treatment, have not consultant. The behavioral health care ++ Additional review of progress and responded to standard care delivered in manager would furnish these services recommendations for changes in a non-psychiatric setting, or require both face-to-face and non-face-to-face, treatment, as indicated, including further assessment and engagement and consult with the psychiatric medications, based on prior to consideration of referral to a consultant minimally on a weekly basis. recommendations provided by the psychiatric care setting. Beneficiaries We proposed that the behavioral health psychiatric consultant; would be treated for an episode of care, care manager would be on-site at the ++ Provision of brief interventions defined as beginning when the location where the treating physician or using evidence-based techniques such behavioral health care manager engages other qualified health care professional as behavioral activation, motivational in care of the beneficiary under the furnishes services to the beneficiary. interviewing, and other focused appropriate supervision of the billing We proposed that the behavioral treatment strategies; practitioner and ending with: health care manager may or may not be ++ Monitoring of patient outcomes • The attainment of targeted a professional who meets all the using validated rating scales; and treatment goals, which typically results requirements to independently furnish relapse prevention planning with in the discontinuation of care and report services to Medicare. If patients as they achieve remission of management services and continuation otherwise eligible, then that individual symptoms and/or other treatment goals of usual follow-up with the treating and are prepared for discharge from physician or other qualified healthcare 5 For example, see https://aims.uw.edu/resource- library/measurement-based-treatment-target. active treatment. professional; or • • 6 For example, see https://aims.uw.edu/ G0504: Initial or subsequent Failure to attain targeted treatment collaborative-care/implementation-guide/plan- psychiatric collaborative care goals culminating in referral to a clinical-practice-change/identify-population-based.

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could report separate services furnished reasons, including that: There may be continue to receive persuasive to a beneficiary receiving the services overlap in behavioral health conditions; comments indicating that the described by G0502, G0503, G0504, and there are concerns that there could be psychiatric CoCM is recommended for G0507 in the same calendar month. modification of diagnoses to fit within broader incorporation into clinical These could include: Psychiatric payment rules which could skew the practice, and recommending that we not evaluation (90791, 90792), accuracy of submitted diagnosis code specify the use of the psychiatric CoCM psychotherapy (90832, 90833, 90834, data; and for many patients for whom codes for only particular behavioral 90836, 90837, 90838), psychotherapy for specialty care is not available, or who health diagnoses. Therefore we are not crisis (90839, 90840), family choose for other reasons to remain in limiting billing and payment for the psychotherapy (90846, 90847), multiple primary care, primary care treatment psychiatric CoCM codes to a specified family group psychotherapy (90849), will be more effective if it is provided set of behavioral health conditions. group psychotherapy (90853), smoking within a model of integrated care that In response to the public comment and tobacco use cessation counseling includes care management and regarding whether we should require a (99406, 90407), and alcohol or psychiatric consultation. diagnosed psychiatric disorder (as substance abuse intervention services Comment: The public comments were opposed to a subclinical or undiagnosed (G0396, G0397). Time spent by the very supportive of our creation of the condition), we are clarifying that as behavioral health care manager on three G-codes for CY 2017 to pay for described, the services require that there activities for services reported services furnished using the psychiatric must be a presenting psychiatric or separately could not be included in the CoCM. The commenters offered a behavioral health condition(s) that, in services reported using time applied to number of recommendations regarding the clinical judgment of the treating G0502, G0503, and G0504. valuation of the codes. Some physician or other qualified health The psychiatric consultant involved commenters requested additional codes, professional, warrants ‘‘referral’’ to the in the ‘‘incident to’’ care furnished sought clarification, or presented behavioral health care manager for under this model would be a medical statements in favor of including the further assessment and treatment professional trained in psychiatry and services of practitioners other than through provision of psychiatric CoCM qualified to prescribe the full range of psychiatrists, especially psychologists services. ‘‘Referral’’ is placed in quotes medications. The psychiatric consultant and social workers, within the proposed because the behavioral health care would advise and make codes. manager may be located in the same recommendations, as needed, for Response: We thank the commenters practice as the treating physician or psychiatric and other medical care, for their support of coding and other qualified health professional, who including psychiatric and other medical valuation for services furnished using in any event provides ongoing oversight diagnoses, treatment strategies the psychiatric CoCM, and for their and continues to treat the beneficiary. including appropriate therapies, recommendations regarding appropriate However, the referring diagnosis (or medication management, medical valuation. We address the comments on diagnoses) may be either pre-existing or management of complications valuation in section II.L of this final made by the treating physician or other associated with treatment of psychiatric rule. We address the comments qualified health professional, and we disorders, and referral for specialty regarding payment for services of are not establishing any specific list of services, that are communicated to the psychologists and social workers below. eligible or included diagnoses or treating physician or other qualified Comment: Several commenters conditions. The treating physician or health care professional, typically expressed concern that making separate other qualified health professional may through the behavioral health care payment for psychiatric CoCM for the not be qualified or able to fully diagnose manager. The psychiatric consultant treatment of mood disorders might all relevant psychiatric or behavioral would not typically see the patient or result in neglecting treatment for other health condition(s) prior to referring the prescribe medications, except in rare mental health conditions. Other beneficiary for psychiatric CoCM circumstances, but could and should commenters expressed support for not services. If in the course of providing facilitate a referral to a psychiatric care designating a limited set of eligible psychiatric CoCM services, it becomes provider when clinically indicated. behavioral health diagnoses. One clear that the referring condition(s) or In the event that the psychiatric commenter stated that requiring a other diagnoses cannot be addressed by consultant furnished services to the diagnosed behavioral health condition psychiatric CoCM services, then we beneficiary directly in the calendar might mean that subclinical issues or understand that the beneficiary should month described by other codes, such as undiagnosed behavioral health be referred for other psychiatric E/M services or psychiatric evaluation conditions would be neglected. treatment or should continue usual (CPT codes 90791 and 90792), those Response: We continue to believe that follow-up care with the treating services could be reported separately by we should not limit billing and payment practitioner, because the episode of the psychiatric consultant. Time spent for the psychiatric CoCM codes to a psychiatric CoCM services ends if there by the psychiatric consultant on limited set of behavioral health is failure to attain targeted treatment activities for services reported conditions. As we understand it, the goals after or despite changes in separately could not be included in the psychiatric CoCM model of care may be treatment, as indicated. Beneficiaries services reported using G0502, G0503, used to treat patients with any receiving care reported using the and G0504. behavioral health condition that is being psychiatric CoCM codes may, but are We also noted that, although the treated by the billing practitioner, not required to have comorbid chronic psychiatric CoCM has been studied including substance use disorders. In or other medical condition(s) that are extensively in the setting of specific the Collaborative Care literature being managed by the treating behavioral health conditions (for reviewed by the Cochrane Collaboration practitioner. example, depression), we received and others, there is stronger evidence of Comment: Several commenters who persuasive comments in response to the effectiveness and cost-effectiveness for supported payment for the proposed CY 2016 proposed rule recommending certain behavioral disorders, codes for psychiatric CoCM services in that we not specify particular diagnoses particularly mood and anxiety primary care settings, raised questions required for use of the codes for several disorders, than for others. However, we about whether these codes could be

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used to bill for services furnished in valued the psychiatric CoCM services in affiliated with or located within the other settings that are not traditional both facility and non-facility settings facility, even though as we discuss primary care settings, such as inpatient (see section II.L on valuation). We are below the billing practitioner must also or long-term care, oncology practices, or not limiting the time that can be perform certain work. For this type of emergency departments. Some of these counted towards the monthly time PFS service, there may be more direct commenters recommended additional requirement to bill the psychiatric practice expense borne by the billing new codes to pay for services furnished CoCM code(s) to time that is spent in practitioner even though the beneficiary in these other settings. the care of an outpatient or a beneficiary is located, for part or all of the month, Response: The psychiatric CoCM residing in the community. However, in a facility receiving institutional trials and real world implementation we also stress that G0502, G0503 and payment. We plan to consider these have mainly included primary care G0504 can only be reported by a treating issues further in the future. practice that broadly includes physician or other qualified health care Comment: One specialty association pediatrics, obstetrics/gynecology, and professional when he or she has supported the proposed psychiatric geriatrics as well as family practice and directed the psychiatric CoCM service CoCM codes, noting that although few general internal medicine. The for the duration of time that he or she of their members would use these codes, psychiatric CoCM has also been used in is reporting it, and has a qualifying they set an important precedent to cardiology and oncology practice, and relationship with individuals providing recognize interdisciplinary care that we believe it could be used in various the service under his or her direction requires significant non-face-to-face medical specialty settings, as long as the and control. Also, time and effort that is work. This commenter anticipated that specialist physician or practitioner is spent managing care transitions for CCM similar code series may be developed in managing the beneficiary’s behavioral or TCM patients and that is counted the future to describe complex health condition(s) as well as other towards reporting TCM or CCM management in other specialties medical conditions (for example, services, cannot also be counted including neurology, and supported the cancer, status-post acute myocardial towards reporting any transitional care adoption of language approved at CPT infarction and other conditions where management activities reported under a that carefully defined the roles of co-morbid depression is common). BHI service code(s), either the multiple professionals. Other Accordingly, we are not limiting the psychiatric CoCM codes or the code commenters similarly expressed support code to reporting by only ‘‘traditional’’ describing other BHI services. We for separate payment for additional primary care specialties. We believe welcome additional input from collaborative care services, including primary care practitioners will most stakeholders regarding appropriate (or inter-professional consultation in the frequently perform the services inappropriate) sites of service for G0502, treatment of other illnesses such as described by the new psychiatric CoCM G0503 and G0504. cancer or multiple sclerosis. codes, but if other specialist Response: We continue to be practitioners perform these services and We note that for CY 2017, the facility interested in new coding that describes meet all of the requirements to bill the PE RVU for psychiatric CoCM services integrative, collaborative or consultative code(s), then they may report the will include the indirect PE allocated care among specialties other than psychiatric CoCM codes. We are based on the work RVUs, but no direct primary care and behavioral health/ interested in receiving additional, more PE (which is explicitly comprised of psychiatry. We are especially interested specific information from stakeholders other labor, equipment and supplies). in new coding that describes such care regarding which specialties furnish This is because historically, the PFS in sufficient detail that distinguishes it psychiatric CoCM services. We note that facility rate for a given professional from existing service codes, and that we would generally not expect service assumes that the billing would further the appropriate valuation psychiatrists to bill the psychiatric practitioner is not bearing a significant of cognitive services. We will continue CoCM codes, because psychiatric work resource cost in labor by other to follow any new coding proposals at is defined as a sub-component of the individuals, equipment or supplies. We CPT relevant for the Medicare psychiatric CoCM codes. generally assume that those costs are population. We note that we have Regarding psychiatric CoCM services instead borne by the facility, and are followed CPT’s lead in finalizing furnished to inpatients or beneficiaries adequately accounted for in a separate proposed code G0505 for cognitive in long-term care settings such as payment made to the facility to account impairment assessment and care nursing or custodial care facilities, we for these costs and other costs incurred planning (see section II.E.5) as well as note that the forthcoming CPT codes are by the facility for the beneficiary’s for psychiatric CoCM services. BHI is a not limited to office or other outpatient facility stay. For BHI services and unique type of service that we believe or domiciliary services. Moreover, our similar care management services such until now has not been well identified goal is to separately identify and pay for as CCM, we have been considering nor appropriately valued under existing psychiatric CoCM services furnished to whether this approach to PFS valuation codes. BHI is not comprised of mere beneficiaries in any appropriate setting is optimal because the PFS service, in consultation among professionals and of care, whether inpatient or outpatient, significant part, may be provided by the has a unique evidence base, in addition in recognition of the associated time and behavioral health care manager, clinical to being recently addressed by service complexity. Care of beneficiaries staff, or even other physicians under the forthcoming CPT coding. In addition, who are admitted to a facility, are in employment of the billing practitioner given the shortage of available long-term care, or are transitioning or under contract to the billing psychiatric and other mental health among settings during the month may practitioner. These individuals may professionals in many parts of the be more complex than the care of other provide much of the PFS service country, we believe it is important to types of patients. While there is some remotely, and are not necessarily identify and make accurate payment for overlap between psychiatric CoCM and employees or staff of the facility. models of care that facilitate access to CCM services, they are distinct services Indeed, the BHI services are defined in psychiatric and other behavioral health with differing patient populations, as terms of activities performed by specialty care through innovations in discussed elsewhere in this section of individual(s) other than the billing medical practice, like the ones our final rule. Therefore, we have practitioner and who may not be described by these codes.

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Comment: One commenter asked planning that incorporates psychiatric CoCM services and G0507) CMS to clarify inclusion of nurse comprehensive health information on to CCM and recommended that CMS practitioners who are primary care all of the beneficiary’s health issues or adopt the same requirements for all the practitioners and, in the specialty of reconciles the care plans of other BHI codes as for CCM, regarding psychiatry, psychiatric nurse practitioners, as would be expected for supervision, location of a behavioral practitioners who can perform CCM care planning. health care manager, and third party psychiatric evaluations and treat We understand that adoption of EHRs outsourcing. psychiatric problems. may be lower among behavioral health Response: For the psychiatric CoCM Response: Nurse practitioners are practitioners 7 and note that resources services, we proposed that the authorized to independently bill are available to help inform how care behavioral health care manager would Medicare for their services, and can also plans can support team-based care and be a member of the treating physician or bill Medicare for services furnished BHI.8 Our understanding from the other qualified health care incident to their services. Therefore, public comments last year and professional’s clinical staff, and would nurse practitioners who furnish the subsequent discussions with experts on be required to be located on site but able psychiatric CoCM services as described the psychiatric CoCM model of care, is to work under general supervision. In may bill for the psychiatric CoCM that no specific electronic technology or addition, we proposed that the codes. Nurse practitioners who meet our format is necessary or indispensable to behavioral health care manager provides final qualifications to serve as the carry out the psychiatric CoCM model of his or her services both face-to-face and behavioral health care manager may care, or perform the services included in non-face-to-face. We believed that provide the behavioral health care the codes we are creating to describe the services provided using the psychiatric manager services incident to the services furnished using that model. We CoCM model of care commonly involve services of another (billing) practitioner. believe the format of the behavioral face-to-face interaction between the Nurse practitioners who meet all of our health care plan (or any care plan) is behavioral health care manager and the final requirements to serve as the less important than having a process beneficiary on appropriate occasions, psychiatric consultant may provide the whereby feedback and expertise from all such as the outset of services (a ‘‘warm psychiatric consultant services incident relevant practitioners and providers, hand-off’’ from the treating physician or to the services of the billing practitioner. whether internal or external to the other qualified health care professional). Comment: Regarding the care billing practice, are integrated into the In addition, whether face-to-face or non- planning requirements for psychiatric beneficiary’s treatment plan and goals; face-to-face, many of the included CoCM services, some commenters noted that this plan be regularly assessed and behavioral health care manager duties that there is not necessarily value in revisited by the practitioner who is could be performed while the treating accumulating or enumerating a number assuming an overall care management practitioner is not in the office and of different types of care plans role for the beneficiary in a given could be performed after hours. We note addressing different aspects of the month; that the patient is engaged in the that the behavioral health care manager beneficiary’s problems, such as a care planning process; and that the care duties are listed in full above, and behavioral or psychiatric care plan, a planning be documented in the medical include care management services, as CCM care plan, and a cognitive record (as with any required element of well as an assessment of needs, impairment care plan (see G0505 in any PFS service). We are revising the including the administration of section II.E.5). validated rating scales, behavioral requirement for care planning by the Response: While the proposed health care planning, provision of brief behavioral health care manager descriptors for the psychiatric CoCM interventions, ongoing collaboration accordingly, that he or she will perform services referred to an ‘‘individualized with the treating physician or other ‘‘behavioral health care planning in treatment plan,’’ not a ‘‘care plan,’’ we qualified health care professional, and relation to behavioral/psychiatric health proposed in addition that the behavioral maintenance of a registry, all in problems, including revision for health care manager would ‘‘develop a consultation with a psychiatric patients who are not progressing or care plan.’’ While any care planning consultant. should take into account the whole whose status changes.’’ The delivery of the psychiatric CoCM patient, our intent is that the care Comment: A number of commenters depends, in part, on continuity of care planning included in the CCM coding recommended that we should not between a given patient and the (and G0506, the CCM initiating visit require the behavioral health care assigned behavioral health care add-on code) will be the most manager for the psychiatric CoCM manager. Also it requires collaboration, comprehensive in nature, addressing all services to be located on site within the integration and ongoing data flow health issues with particular focus on primary care practice. The commenters between the behavioral health care the multiple chronic conditions being noted that in some settings, particularly manager and the treating practitioner managed by the billing practitioner. In rural areas or smaller practices, this may the behavioral health care manager is that sense, the CCM care plan is an be especially important. Some supporting, as well as with the integrative care plan incorporating more commenters assumed that there is also psychiatric consultant who is usually comprehensive health information on a behavioral health care manager for remotely located under the psychiatric all of the beneficiary’s health issues, or G0507 (discussed below). These CoCM model of care. As previously reconciling care plans of other commenters compared BHI services (the discussed, the psychiatric CoCM is an practitioners. In contrast, the BHI care integrative model of care, and in planning will focus on behavioral health 7 See for instance http://dashboard.healthit.gov/ considering our proposal we were quickstats/pages/physician-ehr-adoption- or psychiatric issues, in particular, just trends.php and https:// concerned that allowing the behavioral as cognitive impairment care planning www.thenationalcouncil.org/wp-content/uploads/ health care manager to be located will focus on cognitive impairment 2012/10/HIT-Survey-Full-Report.pdf. remotely would compromise their issues, in particular (see section II.E.5). 8 For instance, AHRQ has a variety of resources ability to collaborate, communicate, and on how shared care plans can support team-based We are not requiring the psychiatric care and behavioral health integration at https:// timely treat and share information with CoCM treating practitioner or behavioral integrationacademy.ahrq.gov/playbook/develop- the beneficiary and the rest of the care health consultant to perform care shared-care-plan. team. We are aware of many care

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management companies and health under general supervision, we do not the rest of the care team including the information technology companies that believe the general supervision beneficiary, and is available to provide may seek to provide remote care requirement adequately describes the services face-to-face. management and related services under nature of the relationship and We will monitor this issue going all of the new BHI codes, as they have interactions of the respective team forward, not just for the psychiatric for CCM and similar services recently members for services furnished using CoCM but also for the general BHI adopted under the PFS. We received the psychiatric CoCM or the codes we service code (G0507) we are finalizing, public comments from several such are creating to describe those services. as well as for TCM and CCM services. stakeholders that indicated an interest Moreover it only directly addresses the As we discuss in the final rule section in the provision of BHI services and physical location of the billing on CCM below, we are continuing to related health information technology. practitioner, not the behavioral health consider whether outsourcing certain We understand that there have been care manager, necessarily. aspects of these services to a third party successful implementations (positive After considering the public fragments care, leads to insufficient randomized controlled trials) of the comments, we are not finalizing our involvement and oversight of the billing psychiatric CoCM using remote call proposal that the behavioral health care practitioner or results in services that do centers; however, in these manager must be a member of the not actually represent or facilitate implementations, call center staff were treating physician or other qualified continuous, seamless transitional care not randomly rotated among patients health care professional’s clinical staff. and other required aspects of these and there was ongoing data flow and As some of the psychiatric CoCM services. We will continue to consider connectivity between the behavioral services can be contracted out to a third how to best define the continuity of care health care manager and the other party (subject to rules discussed below), that is required for services furnished members of the care team, as well as the the contracted individuals are not and billed under all of these codes, and patient. Moreover, the behavioral health necessarily employees of the treating whether arrangements for remote care manager would presumably have to practitioner. provision of services whether by a case be on site at least some of the time (even Regarding the face-to-face provision of management company or another entity if under general supervision), in order to services by the behavioral health care increases rather than reduces service provide some of their services in-person manager, we are requiring that the fragmentation. Advances in health with the beneficiary. behavioral health care manager must be information technology provide The fact that we proposed and are available to provide services on a face- opportunities for remote connectivity finalizing general supervision for the to-face basis, but not that face-to-face and interoperability that may assist and psychiatric CoCM codes as we did for services must be provided. We are not be useful, if not necessary, for reducing CCM services (see section II.E.3.b) does finalizing the proposed requirement that care fragmentation. However, remote not mean that general supervision alone the behavioral health care manager must provision of services by entities having suffices to meet the requirements of the be located on site, in order to allow for only a loose association with the psychiatric CoCM for continuity, after-hours or appropriate remote treating practitioner can detract from collaboration and integration among the provision of services. However, to continuous, patient-centered care, care team members, including the ensure clinical integration with the whether or not those entities employ beneficiary. General supervision means treating practitioner and familiarity and certified or other electronic technology. that the service is furnished under the continuity with the beneficiary, which We note that while time spent by the overall direction and control of the are characteristic of services furnished treating practitioner is not explicitly practitioner billing the service, but under the psychiatric CoCM model of counted for in codes G0502, G0503 and without the presence of the practitioner care, we are requiring that the G0504, these codes are valued to being required during the performance behavioral health care manager must include work performed directly by the of the service. This definition does not have a collaborative, integrated treating practitioner. The treating directly govern where individual(s) relationship with the rest of the care practitioner directs the behavioral providing the service on an incident to team members, and be able to perform health care manager and continues to basis are located, whether on site or all of the required elements of the oversee the patient’s care, including remote. Rather, it governs the location psychiatric CoCM services delineated prescribing medications, providing and informs the involvement of the for the behavioral health care manager. treatments for medical conditions, and billing practitioner. The behavioral health care manager making referrals to specialty care when For payment purposes, we are must have the ability to engage the needed. We are finalizing as proposed assigning general supervision to the beneficiary outside of regular clinic that some of these services may be psychiatric CoCM codes because we do hours as necessary to perform their separately billable. However, we wish to not believe it is clinically necessary that duties under the CoCM model, and have emphasize that the treating practitioner the professionals on the team who a continuous relationship with the must remain involved in ongoing provide services other than the treating beneficiary. This does not mean the oversight, management, collaboration practitioner (namely, the behavioral behavioral health care manager is and reassessment as appropriate to bill health care manager and the psychiatric necessarily an employee of or always the psychiatric CoCM codes. consultant) must have the billing physically located within the practice, Comment: We received a number of practitioner immediately available to nor does it require provision of comments requesting that we allow or them at all times, as would be required behavioral health care manager services recognize pharmacists, especially under a higher level of supervision. to the beneficiary on site. The neurologic or psychiatric pharmacists, However, general supervision sets the behavioral health care manager may or doctoral-level clinical psychologists minimum standard for supervision and provide his or her services from a to serve as the psychiatric consultant. does not, by itself, meet the remote location that is remote from the Some commenters were concerned that requirements we are setting for billing billing practitioner or remote from the CMS is advocating pharmacotherapy new codes G0502, G0503 and G0504. beneficiary, subject to incident to rules over psychotherapy by requiring a While certain aspects of psychiatric and regulations in 42 CFR 410.26, if he psychiatric consultant who can CoCM services might be furnished or she has a qualifying relationship with prescribe medication.

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Response: We agree with the qualified clinical staff. Time spent by G0507 (Care management services for commenters that there are multiple administrative or clerical staff cannot be behavioral health conditions, at least 20 types of indicated treatment for counted towards the time required to minutes of clinical staff time, directed behavioral health conditions, including bill G0502, G0503 or G0504. by a physician or other qualified health psychotherapy and other psychosocial Evaluation and management services care professional, per calendar month). interventions as well as (such as face-to-face E/M visits) may be We noted that we would expect this pharmacotherapy that are available and separately billed during the service code to be refined over time as we should be offered to beneficiaries period or on the same day as the receive more information about other receiving psychiatric CoCM services. psychiatric CoCM services, provided BHI models being used and how they Our intent is not to inappropriately steer time is not counted twice towards the are implemented. beneficiaries into medication-based same code. We sought stakeholder input on whether we should consider different treatment, but rather that the psychiatric b. General Behavioral Health Integration increments of time for this code, such as consultant be able to present and (BHI) recommend the full range of treatment a base code plus an add-on code options including but not limited to We recognize that the psychiatric comprised of additional 20 minute medications, and to advise regarding CoCM is prescriptive and that much of increments. We recognized that BHI any medications the beneficiary chooses its demonstrated success may be services furnished under the proposed to take. Under the psychiatric CoCM, attributable to adherence to a set of code may range in resource costs. We the psychiatric consultant must be able elements and guidelines of care. We are believed that appropriate payment for to prescribe medication. As we discuss finalizing the code set discussed above these services would further the in section II.L on valuation of G0502, to pay accurately for care furnished refinement and implementation of BHI G0503 and G0504, we agree with the using this specific model of care, given models of care, and that having commenters who stated that the role of its widespread adoption and recognized utilization data would inform future the psychiatric consultant under these effectiveness. However, we note that refinement of the proposed code’s codes is primarily evaluation and PFS coding, in general, does not dictate valuation. management, which is not within the how physicians practice medicine and Comment: The commenters were scope of pharmacists or clinical believe that it should, instead, reflect supportive of new coding to support psychologists under Medicare rules. the practice of medicine. We also payment for other BHI models of care. Therefore, we are finalizing the role and recognize that there are primary care They believed G0507 could be used by qualifications of the psychiatric practices that are incurring, or may some smaller or medium sized practices consultant as proposed. The general BHI incur, resource costs inherent to who could not conform to the strict code (G0507), which we are finalizing, treatment of patients with similar parameters of the psychiatric CoCM but was intended and may be used to report conditions based on BHI models of care provide very similar services. They also other models of care, where the other than the psychiatric CoCM that stated that G0507 would be appropriate beneficiary may not receive E/M may benefit beneficiaries with to report services furnished under other services from the consultant and the behavioral health conditions (see, for BHI models of care that may not require consultant may only be authorized to example, the approaches described at psychiatric services. We received a few provide psychotherapy or consultation http://www.integration.samhsa.gov/ comments describing particular models regarding medications (see section integrated-care-models). There are a of care in great detail; a few commenters II.E.3.b). variety of care models ranging from referenced the Veterans’ Administration Comment: We received a number of behavioral health professionals BHI care models, the Primary Care comments recommending various types embedded within a primary care office Behavioral Health/Behavioral Health of professionals as qualified to serve as for same-day treatment, to remote Consultation (PCBH/BHC) Model, or the behavioral health care manager, consultation, to assessment-and-referral general models in place within other such as licensed clinical social workers (see, for example, http:// health care systems. However, there was (LCSWs) and psychologists. www.commonwealthfund.org/ consensus among the commenters that Response: Unlike CCM and the publications/newsletters/quality- another code(s) in addition to the general BHI service (code G0507), the matters/2014/august-september/ psychiatric CoCM codes would be psychiatric CoCM codes are used to profiles; and http:// useful to collect information on how report time that is spent in specified www.integration.samhsa.gov/integrated- other behavioral health care models are activities performed by a behavioral care-models). These models of care have being used and implemented. health care manager having formal tended to arise from clinical practice as Many commenters recommended that education or specialized training in opposed to the research environment CMS provide more of a framework or those activities, whether or not the (http://psychnews.psychiatryonline.org/ description of included services and behavioral health care manager is doi/full/10.1176/appi.pn.2014.10b25), provider types without being unduly eligible to directly bill Medicare for and include resource costs that differ in burdensome. Some commenters other services. The behavioral health various respects from those associated recommended service elements similar care manager may or may not be a with the psychiatric CoCM. to the CCM service elements (continuity professional who meets all the To recognize the resource costs of care with a designated member of the requirements to independently furnish associated with furnishing such BHI care team; a written care plan; a and report services to Medicare. The services to Medicare beneficiaries, we comprehensive assessment of behavioral behavioral health care manager must also proposed to make payment using a health or psychiatric and other medical also meet any applicable licensure and new G-code that describes care conditions as well as any functional and state law requirements, which is management for beneficiaries with psychosocial needs, updated as required under 42 CFR 410.26 for all behavioral health conditions under necessary; routine evaluation of patient services provided under the PFS. other models of care. We believe that progress using a tracking system; LCSWs would meet these requirements, the resources associated with such care services should be documented in the as would qualified registered nurses, are not currently adequately recognized medical record and available to other clinical psychologists and other under the PFS. The proposed code was treating professionals). These

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commenters recommended that eligible for the general BHI service (G0507) will condition(s) may be pre-existing or patients should have a diagnosed be: newly diagnosed by the treating psychiatric or substance use disorder • Initial assessment or follow-up practitioner, and may be refined as that requires care management services. monitoring, including the use of treatment progresses. Beneficiaries Several commenters recommended that applicable validated rating scales; receiving services reported under G0507 BHI payments be tied to the use of • Behavioral health care planning in may, but are not required to have behavioral health assessment tools for relation to behavioral/psychiatric health comorbid chronic or other medical screening and collection of treatment problems, including revision for condition(s) that are being managed by outcomes throughout the sessions of patients who are not progressing or the treating practitioner. We are not care in primary care. These commenters whose status changes; limiting billing and payment for G0507 • believed this would better position Facilitating and coordinating to a specified set of behavioral health behavioral health to benefit from the treatment such as psychotherapy, conditions, because there may be movement toward value-based payment pharmacotherapy, counseling and/or overlap in behavioral health conditions; in the future. Some commenters psychiatric consultation; and if we specified only certain diagnoses, • assumed there is a designated Continuity of care with a designated practitioners might modify diagnoses to behavioral health care manager for the member of the care team. fit within payment rules; and for many service described by G0507, and Accordingly, the final code descriptor beneficiaries for whom specialty care is recommended that we adopt similar will be, G0507: Care management not available, or who choose for other rules for this care manager as apply for services for behavioral health reasons to remain within primary care, clinical staff providing CCM services. conditions, at least 20 minutes of their behavioral health condition(s) can clinical staff time, directed by a Response: We continue to believe that be addressed using a model of physician or other qualified health care another code, or set of BHI codes, in integrated care. professional, per calendar month, with addition to the psychiatric CoCM code Regarding rules for clinical staff, we the following required elements: are clarifying that services included in set would be useful to pay appropriately • Initial assessment or follow-up for BHI services furnished to Medicare the code G0507 may be provided monitoring, including the use of directly by the treating practitioner or beneficiaries. We also believe that such applicable validated rating scales; payment could facilitate our ability to provided by other qualifying • Behavioral health care planning in individuals (whom we term ‘‘clinical identify and collect data regarding relation to behavioral/psychiatric health staff’’) under his or her direction, during similar or related BHI service models. problems, including revision for the calendar month service period. We agree with the commenters that we patients who are not progressing or Unlike the psychiatric CoCM codes, for should provide more specificity around whose status changes; G0507 there is not necessarily a specific the services eligible for reporting under • Facilitating and coordinating individual designated as a ‘‘behavioral this other code(s). One way to do this treatment such as psychotherapy, health care manager’’ with formal or would be to create codes with tiered pharmacotherapy, counseling and/or specialized education in providing the times. Some commenters supported psychiatric consultation; and services (although there could be). such an approach, while others believed • Continuity of care with a designated Similarly, there is not necessarily a it would be premature. At this time, we member of the care team. psychiatric or other behavioral health are not creating multiple levels of codes We are aware of a number of validated specialist consultant (although there distinguishing levels of general BHI rating scales that are available for use could be), and we note that G0507 is not services using time or any other metric, for a number of conditions addressed by valued to explicitly account for such a but we may reconsider this in the future BHI models of care, such as those consultant. We will apply the same (also see section II.L on G0507 described by the Kennedy Forum (see definition of the term ‘‘clinical staff’’ valuation). http://thekennedyforum-dot- that we have applied for CCM to G0507, Regarding included elements of the org.s3.amazonaws.com/documents/ namely, the CPT definition of this term, general BHI service (G0507), we agree MBC_supplement.pdf). We are requiring subject to the incident to rules and with the commenters that we should be the use of such scales when applicable regulations and applicable state law, more specific in our definition of this to the condition(s) that are being treated. licensure and scope of practice at 42 service. We wish to provide greater Medication Assisted Treatment (MAT) CFR 410.26. For G0507, then, we note specificity without being overly may be a treatment that is facilitated that the term ‘‘clinical staff’’ will prescriptive, since a range of activities under the facilitating treatment service encompass or include a psychiatric or may be included in BHI models of care element. other behavioral health specialist other than the psychiatric CoCM. We Regarding diagnosis, we believe we consultant, if the treating practitioner believe we should include a core set of should specify similar diagnostic obtains consultative expertise. Clinical service elements that are similar to core criteria for G0507 and the psychiatric staff that provide included services do elements of the psychiatric CoCM, CoCM services (G0502, G0503 and not have to be employed by the treating especially a systematic process for G0504). Accordingly we are providing practitioner or located on site, initial assessment and routine follow up that beneficiaries who are appropriate necessarily, and may or may not be a evaluation, revising the treatment candidates for services billed under professional who is permitted to approach or methods for patients who G0507 will have an identified independently furnish and report are not progressing or whose status psychiatric or behavioral health services to Medicare. Time spent by changes; facilitating and coordinating condition(s) that requires a behavioral administrative or clerical staff cannot be behavioral health expertise and health care assessment, behavioral counted towards the time required to treatment; and designating a member of health care planning, and provision of bill G0507. the care team with whom the interventions. Eligible beneficiaries G0507 is valued to include minimal beneficiary has a continuous must present with a condition(s) that in work by the treating practitioner; the relationship. We may revisit the the treating practitioner’s clinical bulk of the valuation is based on clinical included services in future years, but for judgment, warrants the services staff time (see section II.L on valuation). CY 2017 the required service elements included in G0507. The presenting However, we want to emphasize that the

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treating practitioner must direct the the multiple chronic conditions being Comment: We received a few service, continue to oversee the managed by the treating practitioner. In comments recommending codes in beneficiary’s care, and perform ongoing contrast, the BHI care planning will addition to the psychiatric CoCM codes management, collaboration and focus on behavioral health or that would pay for similar services to reassessment. If the service (or part psychiatric issues, in particular, just as inpatients, or for behavioral health thereof) is provided incident to the the cognitive impairment care planning services by psychologists to treating practitioner’s services, whether will focus on cognitive impairment psychologically and medically complex on site or remotely, the clinical staff issues, in particular (see section II.E.5. patients in skilled nursing facilities providing services must have a of this final rule). (SNF) and nursing homes. Some of these collaborative, integrated relationship However, we understand that commenters stated that in SNF and with the treating practitioner. They adoption of EHRs may be lower among long-term care settings, psychologists must also have a continuous behavioral health practitioners 9 and work closely with primary care relationship with the beneficiary. note that resources are available to help physicians, psychiatrists, nurses, and Evaluation and management services, inform how care plans can support other consultants to improve outcomes such as face-to-face E/M visits, may be team-based care and BHI.10 While we by reducing inappropriate use or dosing separately billed during the service understand that practitioners, in of psychotropic medications, improving period or on the same day as G0507, general, are exploring a wide variety of activities of daily living, and preventing provided time is not counted twice innovative approaches and tools that avoidable admissions/falls. These towards the same code. facilitate care plan integration across commenters stated that many health For payment purposes, we are clinical disciplines, at this time, there systems employ psychologists as BHI categorizing this service as a designated may not be sufficient adoption of team leaders or coordinators, and sought care management service assigned interoperable health IT interoperability clarification on how psychologist-led general supervision for purposes of among all practitioners and providers teams would operationalize the new ‘‘incident to’’ billing, because we do not treating a given beneficiary to BHI codes. These commenters believe believe it is clinically necessary for the necessarily have a single, master care that psychology training provides individuals on the team who provide plan that adequately addresses the unique skills in facilitating services other than the treating progress of the beneficiary in relation to interdisciplinary teams. While they practitioner (namely, clinical staff) to all of these issues. In general, acknowledged that psychologists are not have the treating practitioner practitioners are encouraged to pursue qualified to perform the full range of immediately available to them at all approaches that integrate health BHI services and interventions, they times, as would be required under a information from multiple sources into believed psychologists should be able to higher level of supervision. However, a single care plan, but we understand separately report and bill for care general supervision sets the minimum that practitioners may need to create coordination and BHI initiation standard for supervision and does not, separate documents or the relevant care activities. by itself, meet the requirements we are planning may be documented in another We received similar comments setting for billing new code G0507. format within the medical record. supporting the addition of psychiatric While certain aspects of G0507 might be We believe the format of the care collaborative care services to the PFS, furnished under general supervision, we plan(s) is less important than having a and other evidence-based models in a do not believe the general supervision variety of primary care-based treatment process whereby feedback and expertise requirement adequately describes the settings. However, these commenters from all relevant practitioners and nature of the relationship and supported the inclusion of social providers, whether internal or external interactions of the respective team workers at all levels of licensures as to the billing practice, are integrated members for services furnished using reimbursable providers of these into the beneficiary’s treatment plan and BHI models of care or the codes we are services. creating to describe those services. goals; that this plan be regularly Response: We appreciate the Moreover the general supervision assessed and revisited by the commenters’ descriptions of some requirement only directly addresses the practitioner who is assuming an overall particular working models of care, and physical location of the treating care management role for the we welcome additional information in practitioner, not the location of clinical beneficiary in a given month; that the this regard. We continue to believe it staff, necessarily. patient is engaged in the care planning would be appropriate to have new Comment: Regarding behavioral process; and that the care planning be coding for a range of BHI care models health care planning, some commenters documented in the medical record (as applicable to inpatient as well as noted that there is not necessarily value with any required element of any PFS outpatient and facility settings. Our goal in accumulating or enumerating a service). We have framed the care in separately identifying and paying for number of different types of care plans planning service element for G0507 BHI services is to prioritize accurate addressing different aspects of the accordingly, ‘‘Behavioral health care payment for these services, in beneficiary’s problems, such as a planning in relation to behavioral/ recognition of the associated time and behavioral or psychiatric care plan, a psychiatric health problems, including complexity of the services. We agree CCM care plan, and a cognitive revision for patients who are not that beneficiaries who are admitted to a impairment care plan (see G0505 in progressing or whose status changes.’’ facility, are in long-term care, or are section II.E.5). transitioning among settings during the Response: While any care planning 9 See for instance http://dashboard.healthit.gov/ month are likely to be more complex quickstats/pages/physician-ehr-adoption- should take into account the whole trends.php and https:// than other types of patients, and to patient, our intent is that the care www.thenationalcouncil.org/wp-content/uploads/ warrant more- not less- BHI services. planning included in the CCM coding 2012/10/HIT-Survey-Full-Report.pdf. Therefore, we have valued G0507 in (and G0506, the CCM initiating visit 10 For instance, AHRQ has a variety of resources both facility and non-facility settings on how shared care plans can support team-based add-on code) will be the most care and behavioral health integration at https:// (see section II.L on valuation). We are comprehensive in nature, addressing all integrationacademy.ahrq.gov/playbook/develop- not limiting the time that can be health issues with particular focus on shared-care-plan. counted towards the monthly time

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requirement to bill G0507 to time that designed to include services that require activities of daily living, and preventing is spent in the care of an outpatient or the oversight and involvement of a avoidable admissions and falls. a beneficiary residing in the community. practitioner who can perform evaluation Response: We appreciate the As we provide for the psychiatric CoCM and management services, including commenters’ feedback. We agree that services, G0507 may be reported by facilitation of any needed psychologists would be qualified to specialties that are not ‘‘traditional’’ pharmacotherapy, referral for specialty perform care coordination that is primary care specialties, if such care, and overall management of the included in the psychiatric CoCM codes specialists furnish the included beneficiary’s treatment in relation to (G0502, G0503 and G0504) and the services. However, we stress that G0507 primary care treatment. We note that general BHI code (G0507) under the can only be reported by a treating G0507 would not be independently direction of a physician or other physician or other qualified health care billed by psychologists or social qualified health care professional. In professional when he or she has workers, though from our understanding addition, beneficiaries receiving BHI directed the BHI service for the duration of various models of BHI, these services under any of those codes may of time that he or she is reporting it, and professionals seem likely to be be referred to psychologists for has a qualifying relationship with participants in team-based care for psychotherapy or other services that are individuals providing the service under beneficiaries receiving these services. separately billable and within the scope of practice of psychologists, as his or her direction and control. Also, c. BHI Initiating Visit time and effort that is spent managing discussed elsewhere in this section of care transitions for CCM or TCM Similar to CCM services (see section our final rule. However many patients and that is counted towards II.E.4), we proposed to require an commenters acknowledged, and we reporting TCM or CCM services, cannot initiating visit for all of the BHI codes agree, that a BHI initiating visit is also be counted towards reporting any (G0502, G0503, G0504 and G0507) that necessary. The initiating visit is not, in transitional care management activities would be billable separate from the BHI its entirety, within the scope of reported under a BHI service code(s). services themselves. We proposed that psychologist practice. Therefore, we are We welcome additional input from the same services that can serve as the finalizing our proposal that the same stakeholders regarding appropriate (or initiating visit for CCM services (see services that qualify as the initiating inappropriate) settings of service for section II.E.4.a. of this final rule) could visit for CCM will also qualify as G0507. serve as the initiating visit for the initiating services for BHI, and they do proposed BHI codes. The initiating visit not include in-depth psychological Since the BHI initiating visit that is would establish the beneficiary’s evaluation by a psychologist. Also, we required to bill G0507 is not within the relationship with the billing practitioner will require an initiating visit for BHI scope of practice of a psychologist or (most aspects of the BHI services would only for new patients or beneficiaries social worker (see below), psychologists be furnished incident to the billing not seen within a year of and social workers will not be able to practitioner’s professional services), commencement of BHI services (the report G0507 directly (although a ensure the billing practitioner assesses same requirement we are finalizing for psychiatrist may be able to do so). the beneficiary prior to initiating care CCM, see section II.E.4.a). As more Psychologists and social workers may management processes, and provide an experience is gained with the provide care management services opportunity to obtain beneficiary psychiatric CoCM services and other included in G0507 incident to the consent (discussed below). We solicited models of BHI care, we may reassess services of another (billing) practitioner. public comment on the types of services these provisions. They may also provide services that are that are appropriate for an initiating As discussed above, we are interested separately billable during the service visit for the BHI codes, and within what in receiving input from stakeholders period. We appreciate the commenters’ timeframe the initiating visit should be regarding circumstances other than BHI support for team-based care, and we conducted prior to furnishing BHI in which behavioral health care recognize the substantial role of various services. management services by a psychologist, types of mental health professionals Comment: The commenters were social worker or similarly qualified within a primary care team. We are largely supportive of our proposal to professional should be reportable in its interested in receiving additional input allow the same services to qualify for own right, rather than incident to the from stakeholders as to whether and the initiating visit to CCM as for the services of a practitioner authorized to why behavioral health care management initiating visit to BHI services. We bill Medicare for a BHI initiating visit. services by a social worker, psychologist received a few comments stating that in Comment: Some commenters or similarly qualified professional addition to the qualifying E/M services recommended that CMS establish an should be reportable in its own right, (or an AWV or IPPE), initiating services add-on code to the initiating visit for rather than incident to the services of a should include in-depth psychological BHI services, parallel to G0506 (the practitioner authorized to bill Medicare evaluations delivered by a psychologist proposed add-on code for the CCM for a BHI initiating visit. Consistent with including CPT codes 90791, 96116 or initiating visit). our recent approaches to making 96118 which, in turn, include care plan Response: We do not believe we have proposals under PFS notice and development. These commenters agreed enough information about practice comment rulemaking, we could that psychologists cannot personally patterns at this time to create an add-on consider adopting new coding under a furnish all BHI services (for example, code to the BHI initiating visit, and we different construct that was not defined medication reconciliation), but believe did not propose such a code. We may as BHI, if stakeholders provided psychologists effectively coordinate care re-examine this issue in the future. sufficient input on how to design, and perform other aspects of BHI define and value the services. We would services as part of a team under current d. Beneficiary Consent for BHI Services also consider such changes if adopted practice models. They believe this Commenters to the CY 2016 PFS by the CPT Editorial Panel, per our approach would be particularly effective proposed rule indicated that they did usual process. BHI integrates behavioral for reducing inappropriate use or dosing not believe a specific patient consent for health expertise into evaluation and of psychotropic medications in elderly BHI services is necessary and indicated management care. Therefore G0507 is and complex patients, improving that requiring special informed consent

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for these services may reduce access due per month, or appropriate for more than duration of time reported, and has a to stigma associated with behavioral one practitioner (whether in the same qualifying relationship with individuals health conditions. Instead, the practice or different practices) to bill for providing the reported services under commenters recommended requiring a services furnished in a BHI care model his or her direction and control. We more general consent prior to initiating per month. would not expect a single practitioner to these services whereby the beneficiary Response: We agree with the furnish care to a given beneficiary under gives the initiating physician or commenters that physician-to-physician more than one BHI model of care during practitioner permission to consult with communication as well as a given month. Therefore a single relevant specialists, which would communication within treatment teams practitioner must choose whether to include conferring with a psychiatric happens routinely, without an extra report psychiatric CoCM code(s) (G0502, consultant. Accordingly, we proposed to layer of formal written consent, for other G0503, and G0504 as applicable) or the require a general beneficiary consent to medical conditions. However there are general BHI code (G0507) for a given consult with relevant specialists prior to particular privacy concerns addressed month for a given beneficiary. We initiating these services, recognizing by other rules and regulations for some remind stakeholders that time cannot be that applicable rules continue to apply behavioral health or substance use care. counted more than once towards any regarding privacy. The proposed general Also we are concerned that beneficiaries code(s), all services must be medically consent would encompass conferring should not incur unexpected expenses reasonable and necessary, and that with a psychiatric consultant when for care that is largely, or in significant beneficiary cost sharing and advance furnishing the psychiatric CoCM codes part, non-face-to-face in nature. Finally, consent apply. We will be monitoring (G0502, G0503, and G0504) or the there are issues to consider, that we the claims data and studying the proposed broader BHI code (G0507). considered for CCM, regarding utilization patterns. We will continue to Similar to the proposed beneficiary prevention of duplicative practitioner assess appropriate reporting patterns, consent process for CCM services, we billing, and whether BHI services can and we expect that potential coding proposed that the billing practitioner actually be furnished under the changes by the CPT Editorial Panel may must document in the beneficiary’s direction and control of any given inform this issue. medical record that the beneficiary’s practitioner if for a given service period, Comment: We received a number of consent was obtained to consult with more than one practitioner is furnishing comments recommending that cost relevant specialists including a BHI services and billing them. sharing be removed for all care The public comments were psychiatric consultant, and that, as part management services, whether through supportive of our proposal for a broad of the consent, the beneficiary is legislative change, demonstration, consent that could be verbally obtained informed that there is beneficiary cost- waiver safe harbor, or designation as but must be documented in the medical sharing, including potential deductible preventive services. and coinsurance amounts, for both in- record, and we are finalizing as proposed. At this time, we do not Response: We appreciate commenters’ person and non-face-to-face services concerns and recognize many of the that are provided. We solicited believe a single consent process for both BHI and CCM is advisable. It is not clear challenges associated with patient cost- stakeholder comments on this proposal. sharing for these kinds of services. At We recognized that special informed how frequently BHI and CCM would or this time, we do not have authority to consent could also be helpful in cases should be furnished concurrently. BHI waive cost sharing for the BHI or other when a particular service is limited to and CCM are distinct, separate services, being billed by a single practitioner for having significant differences in time care management services. We a particular beneficiary. We did not thresholds, the nature of the services, appreciate the commenters’ believe that there are circumstances types of individuals providing the acknowledgement of our current where it would reasonable for multiple services, and payment and cost sharing limitations and we will continue to practitioners to be reporting these codes amounts. Therefore, at this time, we are consider this issue. during the same month. However, we maintaining separate consent processes e. Summary of Final BHI Policies did not propose a formal limit at this for CCM and BHI, as provided in the time. We solicited comment on whether respective sections of this final rule. Beginning in CY 2017, we are such a limitation would be beneficial or Also, as discussed in section II.E.4 on providing separate payment for a range whether there are circumstances under CCM, CCM and BHI may be billed of BHI services. Specifically, we are which a beneficiary might reasonably during the same service period. providing payment for psychiatric receive BHI services from more than one It remains unclear whether it would CoCM services under the following be reasonable and necessary for more codes: practitioner during a given month. • Comment: The commenters were than one practitioner (whether in the G0502: Initial psychiatric largely supportive of our proposal same practice or different practices) to collaborative care management, first 70 regarding BHI consent, some noting that bill BHI services for a given beneficiary minutes in the first calendar month of physician-to-physician communication for a given service period, given the lack behavioral health care manager as well as communication within of public response and input on this activities, in consultation with a treatment teams happens routinely, issue. It may depend on the psychiatric consultant, and directed by without an extra layer of formal written conditions(s) being treated and whether the treating physician or other qualified consent, for other medical conditions. A specialty care, other than psychiatric or health care professional, with the few commenters intimated that CMS behavioral health specialty care, and following required elements: might pursue a single broad consent that primary care are both involved. We are ++ Outreach to and engagement in could be used across care management not proposing a formal limit at this time, treatment of a patient directed by the services; for example, applying for both but we stress that BHI services can only treating physician or other qualified CCM and BHI. We did not receive any be reported by a treating physician or health care professional; public comments delineating the other qualified health care professional ++ Initial assessment of the patient, circumstances under which it would be when he or she has obtained the including administration of validated appropriate to bill for services furnished required beneficiary consent, directed rating scales, with the development of using more than one BHI service model the BHI services he or she reports for the an individualized treatment plan;

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++ Review by the psychiatric month service period. These services • Lack of continued engagement with consultant with modifications of the may be furnished when a beneficiary no psychiatric collaborative care plan if recommended; has a psychiatric or behavioral health management services provided over a ++ Entering patient in a registry and condition(s) that in the treating consecutive 6-month calendar period tracking patient follow-up and progress physician or other qualified health care (break in episode). using the registry, with appropriate professional’s clinical judgment, A new episode of care will start after a documentation, and participation in requires a behavioral health care break in episode of 6 calendar months weekly caseload consultation with the assessment; establishing, implementing, or more. psychiatric consultant; and revising, or monitoring a care plan; and The treating physician or other ++ Provision of brief interventions provision of brief interventions. The qualified health care professional using evidence-based techniques such diagnosis or diagnoses may be pre- directs the behavioral health care as behavioral activation, motivational existing or made by the treating manager and continues to oversee the interviewing, and other focused physician or other qualified health care beneficiary’s care, including prescribing treatment strategies. professional, and may be refined over medications, providing treatments for • G0503: Subsequent psychiatric time. The psychiatric CoCM services medical conditions, and making collaborative care management, first 60 may be furnished to beneficiaries with referrals to specialty care when needed. minutes in a subsequent month of any psychiatric or behavioral health The treating physician or other qualified behavioral health care manager condition(s) that is being treated by the health care professional must remain activities, in consultation with a physician or other qualified health care involved in ongoing oversight, psychiatric consultant, and directed by professional, including substance use management, collaboration and the treating physician or other qualified disorders. Beneficiaries receiving reassessment as appropriate to bill the health care professional, with the psychiatric CoCM services may, but are psychiatric CoCM codes. following required elements: not required to have comorbid chronic The behavioral health care manager ++ Tracking patient follow-up and or other medical condition(s) that are has formal education or specialized progress using the registry, with being managed by the treating training in behavioral health (which appropriate documentation; practitioner. could include a range of disciplines, for ++ Participation in weekly caseload Psychiatric CoCM services include the example, social work, nursing, and consultation with the psychiatric services of the treating physician or psychology). The behavioral health care consultant; other qualified health care professional, manager provides care management ++ Ongoing collaboration with and the behavioral health care manager (see services, as well as an assessment of coordination of the patient’s mental description below) who provides needs, including the administration of health care with the treating physician services incident to services of the validated rating scales; 11 behavioral or other qualified health care treating physician or other qualified health care planning in relation to professional and any other treating health care professional, and the behavioral/psychiatric health problems, mental health providers; including revision for patients who are ++ Additional review of progress and psychiatric consultant (see description not progressing or whose status changes; recommendations for changes in below) whose consultative services are provision of brief interventions; ongoing treatment, as indicated, including furnished incident to services of the collaboration with the treating medications, based on treating physician or other qualified physician or other qualified health care recommendations provided by the health care professional. Time spent by administrative or clerical staff cannot be professional; maintenance of a psychiatric consultant; 12 ++ Provision of brief interventions counted towards the time required to registry; all in consultation with the using evidence-based techniques such bill the psychiatric CoCM service codes. psychiatric consultant. The behavioral as behavioral activation, motivational Beneficiaries receiving psychiatric health care manager is available to interviewing, and other focused CoCM services may have newly provide these services face-to-face and treatment strategies; diagnosed conditions, need help in non-face-to-face, and consults with the ++ Monitoring of patient outcomes engaging in treatment, have not psychiatric consultant minimally on a using validated rating scales; and responded to standard care delivered in weekly basis. relapse prevention planning with a non-psychiatric setting, or require The behavioral health care manager patients as they achieve remission of further assessment and engagement must have a collaborative, integrated symptoms and/or other treatment goals prior to consideration of referral to a relationship with the rest of the care and are prepared for discharge from psychiatric care setting. Beneficiaries team members, and be able to perform active treatment. are treated for an episode of care, all of the required elements of the • G0504: Initial or subsequent defined as beginning when the service delineated for the behavioral psychiatric collaborative care behavioral health care manager engages health care manager. The behavioral management, each additional 30 in care of the beneficiary under the health care manager must have the minutes in a calendar month of appropriate supervision of the billing ability to engage the beneficiary outside behavioral health care manager practitioner and ending with: of regular clinic hours as necessary to activities, in consultation with a • The attainment of targeted perform the behavioral health care psychiatric consultant, and directed by treatment goals, which typically results manager’s duties under the psychiatric the treating physician or other qualified in the discontinuation of care CoCM model, and must have a health care professional (List separately management services and continuation continuous relationship with the in addition to code for primary of usual follow-up with the treating beneficiary. The behavioral health care procedure) (Use G0504 in conjunction physician or other qualified healthcare manager may or may not be a with G0502, G0503). professional; or These psychiatric CoCM services are • Failure to attain targeted treatment 11 For example, see https://aims.uw.edu/resource- goals culminating in referral to a library/measurement-based-treatment-target. reported by the treating physician or 12 For example, see https://aims.uw.edu/ other qualified health care professional psychiatric care provider for ongoing collaborative-care/implementation-guide/plan- for services furnished during a calendar treatment; or clinical-practice-change/identify-population-based.

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professional who meets all the the treating physician or other qualified collaborative, integrated relationship requirements to independently furnish health care professional’s clinical with the treating practitioner. They and report services to Medicare. The judgment, requires a behavioral health must also have a continuous behavioral health care manager is care assessment, behavioral health care relationship with the beneficiary. subject to the incident to rules and planning, and provision of For all of the BHI service codes regulations and applicable state law, interventions. The presenting (G0502, G0503, G0504 and G0507), we licensure and scope of practice (see 42 condition(s) may be pre-existing or are requiring an initiating visit that is CFR 410.26). newly diagnosed by the treating billable separate from the BHI services The psychiatric consultant is a physician or other qualified health care themselves. The same services that medical professional trained in professional, and may be refined over qualify as initiating visits for CCM psychiatry and qualified to prescribe the time. Beneficiaries receiving services services can serve as the initiating visit full range of medications. The reported under G0507 may have any for BHI services (certain face-to-face E/ psychiatric consultant advises and psychiatric or behavioral health M services including the face-to-face makes recommendations, as needed, for condition(s) that is being treated by the visit required for TCM services, and the psychiatric and other medical care, physician or other qualified health care AWV or IPPE). The BHI initiating visit including psychiatric and other medical professional, including substance use establishes the beneficiary’s relationship diagnoses, treatment strategies disorders. Beneficiaries receiving with the treating practitioner (BHI including appropriate therapies, services reported under G0507 may, but services may be furnished incident to medication management, medical are not required to have comorbid the treating practitioner’s professional management of complications chronic or other medical condition(s) services); ensures that the treating associated with treatment of psychiatric that are being managed by the treating practitioner assesses the beneficiary disorders, and referral for specialty practitioner. prior to initiating care management services, that are communicated to the processes; and provides an opportunity Services reported under G0507 may treating physician or other qualified to obtain beneficiary consent (consent be provided directly by the treating health care professional, typically may also be obtained outside of the BHI physician or other qualified health care through the behavioral health care initiating visit, as long as it is obtained professional, or provided by clinical manager. The psychiatric consultant prior to commencement of BHI staff under his or her direction, during does not typically see the beneficiary or services). a calendar month service period. For prescribe medications, except in rare For all of the BHI service codes, we G0507, there is not necessarily a specific circumstances, but can and should are also requiring prior beneficiary individual designated as a ‘‘behavioral facilitate referral for direct provision of consent, recognizing that applicable health care manager’’ with formal or psychiatric care when clinically rules continue to apply regarding specialized education in providing the indicated. The psychiatric consultant is privacy. The consent will include services (although there could be). subject to the incident to rules and permission to consult with relevant Similarly, there is not necessarily a regulations and applicable state law, specialists including a psychiatric psychiatric or other behavioral health licensure and scope of practice (see 42 consultant, and inform the beneficiary specialist consultant (although there CFR 410.26). that cost sharing will apply to in-person Beginning in CY 2017, we are could be) and we note that G0507 is not and non-face-to-face services provided. providing separate payment for BHI valued to explicitly account for expert Consent may be verbal (written consent services furnished under models of care consultation. For G0507, the term is not required) but must be other than the psychiatric CoCM model, ‘‘clinical staff’’ means the CPT documented in the medical record. under HCPCS code G0507: Care definition of this term, subject to the For payment purposes, we are management services for behavioral incident to rules and regulations and assigning general supervision to all of health conditions, at least 20 minutes of applicable state law, licensure and the BHI service codes (G0502, G0503, clinical staff time, directed by a scope of practice at 42 CFR 410.26. For G0504 and G0507). However we note physician or other qualified health care G0507, then, we note that the term that general supervision does not, by professional, per calendar month, with ‘‘clinical staff’’ will encompass or itself, comprise a qualifying relationship the following required elements: include any psychiatric or other between the treating practitioner and • Initial assessment or follow-up behavioral health specialist consultant other individuals providing BHI monitoring, including the use of that may provide consultative services. services under the incident to applicable validated rating scales; Clinical staff providing services are not relationship. Also we note that we • Behavioral health care planning in required to be employed by the treating valued BHI services in both facility and relation to behavioral/psychiatric health practitioner or located on site, and these non-facility settings. BHI services may problems, including revision for individuals may or may not be a be furnished to beneficiaries in any patients who are not progressing or professional permitted to independently setting of care. Time that is spent whose status changes; furnish and report services to Medicare. furnishing BHI services to a beneficiary • Facilitating and coordinating Time spent by administrative or clerical who is an inpatient or in any other treatment such as psychotherapy, staff cannot be counted towards the time facility setting during service provision pharmacotherapy, counseling and/or required to report G0507. We emphasize or for any part of the service period may psychiatric consultation; and that the physician or other qualified be counted towards reporting a BHI • Continuity of care with a designated health care professional must direct the code(s). We refer the reader to our member of the care team. service, continue to oversee the discussion above on this matter, as well G0507 is reported by the treating beneficiary’s care, and perform ongoing as reporting by specialty, intersection physician or other qualified health care management, collaboration and with other services, and potential professional for services furnished reassessment. If the service (or part reporting by more than one practitioner during a calendar month service period. thereof) is provided incident to services for a given beneficiary within a service This service may be furnished when the of the treating practitioner, whether on period. A single practitioner must beneficiary has a psychiatric or site or remotely, the clinical staff choose whether to report psychiatric behavioral health condition(s) that in providing services must have a CoCM code(s) (G0502, G0503, and

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G0504 as applicable) or the general BHI spend increasing amounts of time and patient, family and caregiver code (G0507) for a given month (service effort managing the care of comorbid engagement; and timely coordination of period) for a given beneficiary. beneficiaries outside of face-to-face E/M care through electronic health visits, for example, complex and information exchange. Accordingly, we 4. Reducing Administrative Burden and multidisciplinary care modalities that established a set of scope of service Improving Payment Accuracy for involve regular physician development elements and payment rules in addition Chronic Care Management (CCM) and/or revision of care plans; to or in lieu of those established in CPT Services subsequent report of patient status; guidance (in the CPT code descriptor Beginning in CY 2015, we review of laboratory and other studies; and CPT prefatory language), that the implemented separate payment for CCM communication with other health care physician or nonphysician practitioner services under CPT code 99490 (Chronic professionals not employed in the same must satisfy to fully furnish CCM care management services, at least 20 practice who are involved in the services and report CPT code 99490 (78 minutes of clinical staff time directed by patient’s care; integration of new FR 74414 through 74427, 79 FR 67715 a physician or other qualified health information into the care plan; and/or through 67730, and 80 FR 14854). We professional, per calendar month, with adjustments of medical therapy. established requirements to furnish a the following required elements: Therefore, in the CY 2014 PFS final preceding qualifying visit, obtain • Multiple (two or more) chronic rule with comment period, we advance written beneficiary consent, conditions expected to last at least 12 established a separate payment under use certified electronic health record months, or until the death of the patient; the PFS for CPT code 99490 (78 FR (EHR) technology to furnish certain • Chronic conditions place the 43341 through 43342). We sought to elements of the service, share the care patient at significant risk of death, acute include a relatively broad eligible plan and clinical summaries exacerbation/decompensation, or patient population within the code electronically, document specified functional decline; descriptor, established a moderate • activities, and other items summarized Comprehensive care plan payment amount, and established in Table 11 of our CY 2017 proposed established, implemented, revised, or bundled payment for concurrently new rule. For the CCM service elements for monitored). CPT codes that were reserved for which we required use of a certified In the CY 2015 final rule with beneficiaries requiring ‘‘complex’’ CCM EHR, the billing practitioner must use, comment period, we finalized a services (base CPT code 99487 and its at a minimum, technology meeting the proposal to make separate payment for add-on code 99489) (79 FR 67716 edition(s) of certification criteria that is CCM services as one initiative in a through 67719). We stated that we acceptable for purposes of the EHR series of initiatives designed to improve would evaluate the services reported Incentive Programs as of December 31st payment for, and encourage long-term under CPT code 99490 to assess of the calendar year preceding each PFS investment in, care management whether the service is targeted to the payment year. (For the CY 2017 PFS services (79 FR 67715). In particular, we right population and whether the payment year, this would mean sought to address an issue raised to us payment amount is appropriate (79 FR technology meeting the 2014 edition of by the physician community, which 67719). We remind stakeholders that certification criteria). stated that the care management CMS did not limit the eligible These elements and requirements for included in many of the existing E/M population to any particular list of separately payable CCM services are services, such as office visits, does not chronic conditions other than the extensive and generally exceed those adequately describe the typical non- language in the CPT code descriptor. required for payment of codes face-to-face care management work Accordingly, one or more of the chronic describing procedures, diagnostic tests, required by certain categories of conditions being managed through CCM or other E/M services under the PFS. In beneficiaries (78 FR 43337). We began to services could be chronic mental health addition, both CPT guidance and re-examine how Medicare should pay or behavioral health conditions or Medicare rules specify that only a single under the PFS for non-face-to-face care chronic cognitive disorders, as long as practitioner who assumes the care management services that were bundled the chronic conditions meet the management role for a given beneficiary into the PFS payment for face-to-face E/ eligibility language in the CPT code can bill CPT code 99490 per service M visits, being included in the pre- and descriptor for CCM services and the period (calendar month). Because the post-encounter work (78 FR 43337). In billing practitioner meets all of new CCM service closely overlapped proposing separate payment for CCM, Medicare’s requirements to bill the code with several Medicare demonstration we acknowledged that, even though we including comprehensive, patient- models of advanced primary care (the had previously considered non-face-to- centered care planning for all health Multi-Payer Advanced Primary Care face care management services as conditions. Practice (MAPCP) demonstration and bundled into the payment for face-to- In finalizing separate payment for the Comprehensive Primary Care face E/M visits, the E/M office/ CPT code 99490, we considered Initiative (CPCI)), we provided that outpatient visit CPT codes may not whether we should develop standards to practitioners participating in one of reflect all the services and resources ensure that physicians and other these two initiatives could not be paid required to furnish comprehensive, practitioners billing the service would for CCM services furnished to a coordinated care management for have the capability to fully furnish the beneficiary attributed by the initiative to certain categories of beneficiaries. We service (79 FR 67721). We sought to their practice (79 FR 67729). stated that we believed that the make certain that the newly payable Given the non-face-to-face nature of resources required to furnish complex PFS code(s) would provide beneficiary CCM services, we also sought to ensure chronic care management services to access to appropriate care management that beneficiaries would receive beneficiaries with multiple (that is, two services that are characteristic of advance notice that Part B cost sharing or more) chronic conditions were not advanced primary care, such as applies since we currently have no adequately reflected in the existing E/M continuity of care; patient support for legislative authority to ‘‘waive’’ cost codes. Medical practice and patient chronic diseases to achieve health goals; sharing for this service. Also since only complexity required physicians, other 24/7 patient access to care and health one practitioner can bill for CCM each practitioners and their clinical staff to information; receipt of preventive care; service period, we believed the

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beneficiary notice requirement would CCM services for each patient, with (List separately in addition to code for help prevent duplicate payment to times ranging between 20 minutes and primary procedure). multiple practitioners. several hours per month. CCM As CPT provides, less than 60 Since the establishment of CPT code beneficiaries tend to exhibit a higher minutes of clinical staff time in the 99490 for separate payment of CCM disease burden, are more likely to be service period could not be reported services, in a number of forums and in dually eligible for Medicare and separately, and similarly, less than 30 public comments to the CY 2016 PFS Medicaid, and are older than the general minutes in addition to the first 60 final rule (80 FR 70921), many Medicare fee-for-service population.13 minutes of complex CCM in a service practitioners have stated that the service However, absent multiple levels of CCM period could not be reported. We would elements and billing requirements are coding, we do not have comprehensive require 60 minutes of services for burdensome, redundant and prevent data on the relative complexity of the reporting CPT code 99487 and 30 them from being able to provide the CCM services furnished to beneficiaries. additional minutes for each unit of CPT services to beneficiaries who could In light of this stakeholder feedback code 99489. benefit from them. Stakeholders have and our mandate under MACRA section We proposed to adopt the CPT stated that CPT code 99490 is 103 to encourage and report on access provision that CPT codes 99487, 99489 underutilized because it is underpaid to CCM services, we proposed several and 99490 may only be reported once relative to the resources involved in changes in the payment rules for CCM per service period (calendar month) and furnishing the services, especially given services. Our primary goal, and our only by the single practitioner who the extensive Medicare rules for statutory mandate, is to pay as assumes the care management role with payment, and they have suggested a accurately as possible for services a particular beneficiary for the service number of potential changes to our furnished to Medicare beneficiaries period. That is, a given beneficiary current payment rules. Stakeholders based on the relative resources required would be classified as eligible to receive continue to believe that many of the to furnish PFS services, including CCM either complex or non-complex CCM CCM payment rules are duplicative, and services. In so doing, we also expect to during a given service period, not both, to recommend that we reduce the rules facilitate beneficiaries’ access to and only one professional claim could and expand CCM coding and payment reasonable and necessary CCM services be submitted to the PFS for CCM for that to distinguish among different levels of that improve health outcomes. First, for service period by one practitioner. patient complexity. We also note that CY 2017 we proposed to more Comment: Several commenters were section 103 of the MACRA requires appropriately recognize and pay for the supportive of separate payment for CMS to assess and report to Congress other codes in the CPT family of CCM complex CCM services. Response: We thank the commenters (no later than December 31, 2017) on services (CPT codes 99487 and 99489 for their support and are finalizing access to CCM services by underserved describing complex CCM), consistent separate payment for CPT codes 99487 rural and racial and ethnic minority with our general practice to price populations and to conduct an and 99489 as proposed. As finalized, services according to their relative these separate payments for complex outreach/education campaign that is ranking within a given family of underway. CCM services will support care services. We direct the reader to section management for the most complex and The professional claims data for CPT II.L of this final rule for a discussion of code 99490 show that utilization is time-consuming cases of beneficiaries valuation for base CPT code 99487 and with multiple chronic conditions. steadily increasing but may remain low its add-on CPT code 99489. The CPT considering the number of eligible Except for differences in the CPT code code descriptors are: descriptors, we proposed to require the Medicare beneficiaries. To date, • CPT code 99487—Complex chronic approximately 513,000 unique Medicare same CCM service elements for CPT care management services, with the codes 99487, 99489 and 99490. In other beneficiaries received the service an following required elements: average of four times each, totaling $93 words, all the requirements in Table 11 ++ Multiple (two or more) chronic of our proposed rule would apply, million in total payments. Since CPT conditions expected to last at least 12 code 99490 describes a minimum of 20 whether the code being billed for the months, or until the death of the patient; service period is CPT code 99487 (plus minutes of clinical staff time spent ++ Chronic conditions place the CPT code 99489, if applicable) or CPT furnishing CCM services during a month patient at significant risk of death, acute code 99490. These three codes would and does not have an upper time limit, exacerbation/decompensation, or differ in the amount of clinical staff and since we currently do not separately functional decline; service time provided; the complexity of pay the other codes in the CCM family ++ Establishment or substantial medical decision-making as defined in of CPT codes (which would provide us revision of a comprehensive care plan; with utilization data on the number of ++ Moderate or high complexity the E/M guidelines (determined by the patients requiring longer service times medical decision making; problems addressed by the reporting during a billing period), we do not know ++ 60 minutes of clinical staff time practitioner during the month); and the how often beneficiaries required more directed by a physician or other nature of care planning that was than 20 minutes of CCM services per qualified health care professional, per performed (establishment or substantial month. We also do not know their calendar month. revision of the care plan for complex complexity relative to one another, • CPT code 99489—Each additional CCM versus establishment, other than meeting the acuity criteria in 30 minutes of clinical staff time directed implementation, revision or monitoring the CPT code descriptor. Initial by a physician or other qualified health of the care plan for non-complex CCM). information from practitioner interviews care professional, per calendar month Billing practitioners could consider conducted as part of our CCM identifying beneficiaries who require evaluation efforts indicates that 13 Schurrer, John, and Rena Rudavsky. complex CCM services using criteria practitioners overwhelmingly meet and ‘‘Evaluation of the Diffusion and Impact of the suggested in CPT guidance (such as exceed the 20-minute threshold time for Chronic Care Management (CCM) Fees: Third number of illnesses, number of Quarterly Report.’’ Report submitted to the Center medications or repeat admissions or billing CCM. Typically, these for Medicare and Medicaid Innovation. practitioners reported spending between Washington, DC: Mathematica Policy Research, emergency department visits) or the 45 minutes and an hour per month on May 6, 2016. profile of typical patients in the CPT

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prefatory language, but these would not practitioner must discuss CCM with the CCM services. Some recommended a comprise Medicare conditions of patient at this visit. While informed similar coding structure for specialists eligibility for complex CCM. patient consent does not have to be managing a single condition, in place of We proposed several changes to our obtained during this visit, the visit is an prolonged services, or for BHI services. current scope of service elements for opportunity to obtain the required Response: Our intent was to revise the CCM, and proposed that the same scope consent. The face-to-face visit included timeframe for the single CCM initiating of service elements, as amended, would in transitional care management (TCM) visit that is required at the outset of apply to all codes used to report CCM services (CPT codes 99495 and 99496) services. We did not propose services beginning in 2017 (i.e., CPT qualifies as a ‘‘comprehensive’’ visit for subsequent ‘‘re-initiation’’ of CCM codes 99487, 99489 and 99490). In CCM initiation. Levels 2 through 5 E/M services or face-to-face reassessment particular, we proposed changes in the visits (CPT codes 99212 through 99215) within a given timeframe. We discuss requirements for the initiating visit, 24/ also qualify; CMS does not require the further below that we have some 7 access to care and continuity of care, practice to initiate CCM during a level concerns about how to ensure that the format and sharing of the care plan and 4 or 5 E/M visit. However, CPT codes billing practitioner remains involved in clinical summaries, beneficiary receipt that do not involve a face-to-face visit by the beneficiary’s care and continually of the care plan, beneficiary consent and the billing practitioner or are not reassesses the beneficiary’s care, but at documentation. separately payable by Medicare (such as this time we do not believe we should Comment: Commenters were broadly CPT code 99211, anticoagulant require subsequent face-to-face visits supportive of these proposals. We management, online services, telephone within certain timeframes to address received several comments and other E/M services) do not qualify those concerns. recommending changes to the scope of as initiating visits. If the practitioner We believe that the proposed one-year service for non-complex CCM that might furnishes a ‘‘comprehensive’’ E/M, timeframe for the single, CCM initiating improve the distinction between non- AWV, or IPPE and does not discuss visit is appropriate for CY 2017, so we complex and complex CCM and inform CCM with the patient at that visit, that are finalizing as proposed. We will which ‘‘level’’ of service a given visit cannot count as the initiating visit require the CCM initiating visit only for beneficiary is eligible for. For example, for CCM. new patients or patients not seen within these commenters suggested changes to We continued to believe that we the year prior to commencement of CCM the time included in the code descriptor should require an initiating visit in (instead of for all beneficiaries receiving to reflect two or more time increments advance of furnishing CCM services, CCM services). We will continue to for CPT code 99490 using add-on codes, separate from the services themselves, consider in future years whether a or retaining the current low time because a face-to-face visit establishes different timeframe is warranted. The threshold while allowing practitioners the beneficiary’s relationship with the goal of our final policy is to allow to choose among certain service billing practitioner and most aspects of practitioners with existing relationships elements. Some commenters do not the CCM services are furnished incident with beneficiaries who have been seen believe CPT code 99490 is intended for to the billing practitioner’s professional relatively recently to initiate CCM beneficiaries who require all the current services. The initiating visit also ensures services (for the first time) without service elements in a given month, and collection of comprehensive health furnishing a potentially unnecessary that only a more limited set of elements information to inform the care plan. We E/M visit. Regarding subsequent visits is medically necessary for the non- continued to believe that the types of (after CCM services begin), practitioners complex population. face-to-face services that qualify as an are already permitted to furnish and Response: We appreciate the initiating visit for CCM are appropriate. separately bill subsequent E/M visits (or commenters’ recommendations about We did not propose to change the kinds AWVs) for beneficiaries receiving CCM how we might better distinguish of visits that can qualify as initiating services. If a face-to-face reassessment is complex CCM services from non- CCM visits. However, we proposed to reasonable and necessary and furnished complex CCM services. The CPT require the initiating visit only for new by the billing practitioner, then he or Editorial Panel currently maintains the patients or patients not seen within one she may bill an appropriate code coding for CCM services. Further year instead of for all beneficiaries describing the face-to-face assessment of changes in codes and/or descriptors receiving CCM services. We believed a beneficiary to whom they have may be appropriately addressed by CPT this would allow practitioners with previously furnished CCM services. and in subsequent PFS rulemaking. existing relationships with patients who We also proposed for CY 2017 to have been seen relatively recently to create a new add-on G-code that would a. CCM Initiating Visit & Add-On Code initiate CCM services without improve payment for services that (G0506) furnishing a potentially unnecessary qualify as initiating visits for CCM As provided in the CY 2014 PFS final E/M visit. We solicited public comment services. The code would be billable for rule with comment period (78 FR on whether a period of time shorter than beneficiaries who require extensive 74425) and subregulatory guidance one year would be more appropriate. face-to-face assessment and care (available at https://www.cms.gov/ Comment: The commenters were planning by the billing practitioner (as Medicare/Medicare-Fee-for-Service- generally supportive of requiring the opposed to clinical staff), through an Payment/PhysicianFeeSched/ CCM initiating visit only for add-on code to the initiating visit, Downloads/Payment_for_CCM_ beneficiaries who are new patients or G0506 (Comprehensive assessment of Services_FAQ.pdf), CCM must be have not been seen in a year. A few and care planning by the physician or initiated by the billing practitioner commenters suggested a 6-month other qualified health care professional during a ‘‘comprehensive’’ E/M visit, timeframe, or adopting one year and for patients requiring chronic care AWV or IPPE. This face-to-face, reconsidering as we gain more management services (billed separately initiating visit is not part of the CCM experience with CCM. Some from monthly care management service and can be separately billed to commenters misinterpreted our services) (Add-on code, list separately the PFS, but is required before CCM proposal as requiring face-to-face visits in addition to primary service)). services can be provided directly or every year to periodically reassess the We proposed that when the billing under other arrangements. The billing beneficiary or the appropriateness of practitioner initiating CCM personally

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performs extensive assessment and care Response: At this time, we do not provision of CCM services provided by planning outside of the usual effort believe we should permit billing of clinical staff, non-complex CCM (CPT described by the billed E/M code (or G0506 more than once by the billing code 99490) is described based on the AWV or IPPE code), the practitioner practitioner for a given beneficiary. time spent by clinical staff. Complex could bill G0506 in addition to the G0506 was proposed as an add-on code CCM (CPT codes 99487 and 99489) E/M code for the initiating visit (or in to the single initiating visit, to help similarly counts only clinical staff time, addition to the AWV or IPPE), and in ensure the billing practitioner’s although it also includes complex addition to the CCM CPT code 99490 (or assessment and involvement at the medical decision-making by the billing proposed 99487 and 99489) if all outset of CCM services. At this time practitioner. This raises issues regarding requirements to bill for CCM services there are no requirements for the billing appropriate valuation in the facility are also met. We proposed valuation for practitioner to ‘‘re-initiate’’ CCM setting that we will continue to consider G0506 in a separate section of our services; therefore we do not believe we in future rulemaking. The facility PE proposed rule. should create an add-on code for a CCM RVU for CCM includes indirect PE The code G0506 would account ‘‘re-initiation’’ service. We would have (which is an allocation based on specifically for additional work of the to define ‘‘re-initiation’’ and develop physician work), but no direct PE billing practitioner in personally rules regarding when subsequent E/M (which would be comprised of other performing a face-to-face assessment of visits or AWVs are related to the labor, supplies and equipment). This is a beneficiary requiring CCM services, performance of CCM. We do not believe because historically, the PFS facility and personally performing CCM care beneficiaries would understand why rate assumes that the billing practitioner planning (the care planning could be they are incurring additional cost is not bearing a significant resource cost face-to-face and/or non-face-to-face) that sharing for an add-on code to a ‘‘re- in labor by other individuals, equipment is not already reflected in the initiating initiation’’ visit that has not been or supplies. Medicare assumes that visit itself (nor in the monthly CCM required or defined by CMS. those costs are instead borne by the service code). We believed G0506 might As we stated in the CY 2017 proposed facility and adequately accounted for in be particularly appropriate to bill when rule, we were very interested in coding a separate payment made to the facility. the initiating visit is a less complex visit that was presented to the CPT Editorial The PFS non-facility rate generally does (such as a level 2 or 3 E/M visit), Panel, but not adopted, to create code(s) include such costs, assuming that the although G0506 could be billed along that would separately identify and billing practitioner bears the resource account for monthly CCM work by the with higher level visits if the billing costs in clinical and other staff labor, billing practitioner. Such coding may be practitioner’s effort and time exceeded supplies and equipment. a better means of separately identifying For CCM, we have been considering the usual effort described by the and valuing the subsequent work of the whether this approach to valuation initiating visit code. It could also be billing practitioner after CCM is remains appropriate, because the appropriate to bill G0506 when the initiated. We want to establish policies service, in whole or in significant part, initiating visit addresses problems that help ensure that the billing is provided by clinical staff under the unrelated to CCM, and the billing practitioner is not merely handing the direction of the billing practitioner. practitioner does not consider the CCM- beneficiary off to a remote care manager These individuals may provide the related work he or she performs in under general supervision while no service or part thereof remotely, and are determining what level of initiating visit longer remaining involved in their care. not necessarily employees or staff of the to bill. We believed that this proposal We believe that the practitioner billing facility. Under this construct, there may would more appropriately recognize the CCM services should be actively re- be more direct practice expense borne relative resource costs for the work of assessing the beneficiary’s chronic by the billing practitioner that should be the billing practitioner in initiating CCM conditions, reviewing whether separately identified and valued over services, specifically for extensive work treatment goals are being met, updating and above any institutional payment to assessing the beneficiary and the care plan, performing any medical the facility for its staff and establishing the CCM care plan that is decision-making that is not within the infrastructure. We plan to explore these reasonable and necessary, and that is scope of practice of clinical staff, issues in future rulemaking and not accounted for in the billed initiating performing any necessary face-to-face consider other approaches to valuation visit or in the unit of the CCM service care, and performing other related work. that would recognize the accurate itself that is billed for a given service However, it would be more relative resource costs to the billing period. In addition, we believed this straightforward to separately identify practitioner for CCM and similar proposal would help ensure that the this CCM-related work under code(s) services furnished to beneficiaries who billing practitioner personally performs that in their own right describe it, remain or reside in a facility setting and meaningfully contributes to the instead of add-on codes to very broadly during some or all of the service period. establishment of the CCM care plan drawn E/M codes where it becomes Consistent with general coding when the patient’s complexity warrants difficult to assess the relationship guidance, we proposed that the work it. between the two services. Also for that is reported under G0506 (including Comment: Several commenters were beneficiaries receiving complex CCM, time) could not also be reported under supportive of the add-on code (G0506) some of this work is explicitly included or counted towards the reporting of any to the CCM initiating visit to describe in the complex CCM service codes (i.e., other billed code, including any of the physician assessment and care planning medical decision-making of moderate to monthly CCM services codes. The care for patients requiring CCM services. high complexity). Therefore, at this plan that the practitioner must create to Some commenters raised questions time, G0506 will only serve as an add- bill G0506 would be subject to the same about whether G0506 should be a one- on code to describe work performed by requirements as the care plan included time service or could also be billed as the billing practitioner once, in in the monthly CCM services, namely, it an add-on code to subsequent conjunction with the start or initiation must be an electronic patient-centered reassessments by the billing practitioner of CCM services. care plan based on a physical, mental, (whether E/M visits or subsequent We note that despite the role of the cognitive, psychosocial, functional and AWVs). billing practitioner in the initiation and environmental (re)assessment and an

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inventory of resources and supports; a practitioners should consider which We sought to improve alignment with comprehensive care plan for all health service elements were furnished during CPT provisions by removing the issues. This would distinguish it from the service period, who provided them, requirement for the care plan to be the more limited care planning included how much time was spent, and should available remotely to individuals in the BHI codes G0502, G0503, G0504 select the code(s) that most accurately providing CCM services after hours. or G0507 which focus on behavioral and specifically identifies the services Studies have shown that after-hours health issues, or the care planning furnished without duplicative time care is best implemented as part of a included in G0505 which focuses on counting. Practitioners should generally larger practice approach to access and cognitive status. We sought public input select the more specific code(s) when an continuity (see for example, the peer- on potential overlap among these codes alternative code(s) potentially includes review article available at http:// and further clinical input as to how the the services provided. We are not www.ncbi.nlm.nih.gov/pmc/articles/ assessments and care planning that is precluding use of the CCM codes to PMC3475839/). There is substantial included in them would differ. report, or count, behavioral health care local variation in how 24/7 access and We received a number of comments management if it is provided as part of continuity of care are achieved, regarding the relationship between a broader CCM service by a practitioner depending on the contractual proposed G0506, G0505 (Cognition and who is comprehensively overseeing all relationships among practitioners and functional assessment by the physician of the beneficiary’s health issues, even providers in a particular geographic area or other qualified health care if there are no imminent non-behavioral and other factors. Care models include professional in office or other health needs. However, such behavioral various contractual relationships outpatient), prolonged non-face-to-face care management activities could not between physician practices and after- services, and BHI. We address these also be counted towards reporting a BHI hours clinics, urgent care centers and comments in the sections of this final code(s). If a BHI service code more emergency departments; extended rule regarding G0505, prolonged non- specifically describes the service primary care office hours; physician face-to-face services and BHI services furnished (service time and other call-sharing; telephone triage systems; (sections II.E.5, II.E.2 and II.E.3). In relevant aspects of the service being and health information technology such brief, we are not allowing G0506 and equal), or if there is no focus on the as shared EHRs and systematic G0505 to be billed the same day (by a health of the beneficiary outside of a notification procedures (http:// single practitioner). G0506 will not be narrower set of behavioral health issues, www.ncbi.nlm.nih.gov/pmc/articles/ an add-on code for the BHI initiating then it is more appropriate to report the PMC3475839/). Some or all of these may visit or BHI services. G0506 will be a BHI code(s) than the CCM code(s). be used to provide access to urgent care one-time service code for CCM Similarly, it may be more appropriate on a 24/7 basis while maintaining initiation, and the billing practitioner for certain specialists to bill BHI information continuity between must choose whether to report either services than CCM services, since providers. G0506 or prolonged services in specialists are more likely to be association with CCM initiation (if We recognized that some models of managing the beneficiary’s behavioral care require more significant investment requirements to bill both are met). health needs in relation to a narrow The CCM and BHI service codes differ in practice infrastructure than others, subset of medical condition(s). CCM and substantially in potential diagnosis and for example resources in staffing or BHI services can only be billed the same comorbidity, the expected duration of health information technology. In month for the same beneficiary if all the the condition(s) being treated, the kind addition, we believed there is room to requirements to bill each service are of care planning performed reduce the administrative complexity of separately met. We will monitor the (comprehensive care planning versus our current payment rules for CCM care planning focused on behavioral/ claims data, and we welcome further services to accommodate a range of mental health issues), service elements stakeholder input to inform appropriate potential care models. In re-examining and who performs them, and the reporting rules. what should be included in the CCM interventions the beneficiary needs and b. 24/7 Access to Care, Continuity of scope of service elements for 24/7 receives apart from the CCM and BHI Care, Care Plan and Managing Access to Care and Continuity of Care, services themselves. The BHI codes Transitions we believed the CPT language include a more focused process than adequately and more appropriately CCM for the clinical integration of We proposed several revisions to the describes the services that should, at a primary care and behavioral health/ scope of service elements of 24/7 Access minimum, be included in these service psychiatric care, and for continual to Care, Continuity of Care, Care Plan elements. Therefore, we proposed to reassessment and treatment progression and Managing Transitions. We adopt the CPT language for these two to a target or goal outcome that is continued to believe these elements are elements. For 24/7 Access to Care, the specific to mental and behavioral health important aspects of CCM services, but scope of service element would be to or substance abuse issues. However that we should reduce the requirements provide 24/7 access to physicians or there is no explicit BHI service element for the use of specified electronic health other qualified health care professionals for managing care transitions or information technology (IT) in their or clinical staff including providing systematic assessment of receipt of provision. In sum, we proposed to retain patients/caregivers with a means to preventive services; there is no a core requirement to use a certified make contact with health care requirement to perform comprehensive electronic health record (EHR), but professionals in the practice to address care planning for all health issues (not allow fax to count for electronic urgent needs regardless of the time of just behavioral health issues); and there transmission of clinical summaries and day or day of week. We believed the are different emphases on medication the care plan; no longer require access CPT language more accurately reflects management or medication to the electronic care plan outside of the potential role of clinical staff or call- reconciliation, if applicable. In deciding normal business hours to those sharing services in addressing after- which code(s) to report for services providing CCM services; and remove hours care needs than our current furnished to a beneficiary who is standards for clinical summaries in language does. In addition, the 24/7 eligible for both CCM and BHI services, managing care transitions. access would be for ‘‘urgent’’ needs

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rather than ‘‘urgent chronic care needs,’’ standardized communication methods element to require timely electronic because we believed after-hours services as part of effective care. Instead, we sharing of care plan information within typically would and should address any recognized that other CMS initiatives and outside the billing practice, but not urgent needs and not only those (such as MIPS and APMs under the necessarily on a 24/7 basis, and to allow explicitly related to the beneficiary’s Quality Payment Program) may be better transmission of the care plan by fax. chronic conditions. mechanisms to incentivize increased We acknowledged that it is best for We recognized that health interoperability of health information practitioners and providers to have information systems that include remote systems than conditions of payment access to care plan information any time access to the care plan or the full EHR assigned to particular services under the they are providing services to after hours, or a feedback loop that PFS. We also anticipated that improved beneficiaries who require CCM services. communicates back to the primary care accuracy of payment for care This proposal was not intended to physician and others involved in the management services and reduced undermine the significance of electronic beneficiary’s care regarding after-hours administrative burden associated with communication methods other than fax care or advice provided, are extremely billing for them would contribute to transmission in providing effective, helpful (http://www.ncbi.nlm.nih.gov/ practitioners’ capacity to invest in the continuous care. On the contrary, we pmc/articles/PMC3475839/#CR25). best tools for managing the care of believed that fax transmission, while They help ensure that the beneficiary Medicare beneficiaries. commonly used, is much less efficient receives necessary follow up, For Continuity of Care, we currently and secure than other methods of particularly if he or she is referred to the require the ability to obtain successive communicating patient health emergency department, and follow up routine appointments ‘‘with the information, and we encouraged after an emergency department visit is practitioner or a designated member of practitioners to adopt and use electronic required under the CCM element of the care team,’’ while CPT only technologies other than fax for Management of Care Transitions. references successive routine transmission and exchange of the CCM Accordingly, we continued to support appointments ‘‘with a designated care plan. We continued to believe the and encourage the use of interoperable member of the care team.’’ We do not best means of exchange of all relevant EHRs or remote access to the care plan believe there is any practical difference patient health information is through in providing the CCM service elements between these two phrases and therefore standardized electronic means. of 24/7 Access to Care, Continuity of proposed to omit the words However, we recognized that other CMS Care, and Management of Care ‘‘practitioner or’’ from our requirement. initiatives (such as MIPS and APMs Transitions. However, adoption of such The billing practitioner is a member of under the Quality Payment Program) technology would be optimal not only the CCM care team, so the CPT language may be better mechanisms to for CCM services, but also for a number already allows for successive routine incentivize increased interoperability of of other PFS services and procedures appointments either with the billing health information systems than (including various other care practitioner or another appropriate conditions of payment assigned to management services), and we have not member of the CCM care team. particular services under the PFS. We required adoption of any certified or Based on review of extensive public believed our proposal would still allow non-certified health information comment and stakeholder feedback, we timely availability of health information technology as a condition of payment had also come to believe that we should within and outside the practice for for any other PFS service. We noted that not require individuals providing the purposes of providing CCM, and would there are incentives under other beneficiary with the required 24/7 simplify the rules governing provision Medicare programs to adopt such access to care for urgent needs to have of the service and improve access to the information technology, and were access to the care plan as a condition of service. The proposed revisions would concerned that imposing too many EHR- CCM payment. As discussed above, we better align the service with appropriate related requirements at the service level believed that in general, provision of CPT prefatory language, which may as a condition of PFS payment could effective after-hours care of the reduce unnecessary administrative create disparities between these services beneficiary would require access to the complexity for practitioners in and others under the fee schedule. care plan, if not the full EHR. However, navigating the differences between CPT Lastly, we recognized that not all after- we have heard from rural and other guidance and Medicare rules. hours care warrants follow-up or a practices that remote access to the care The CCM scope of service element feedback loop with the practitioner plan is not always necessary or possible Management of Care Transitions managing the beneficiary’s care overall, because urgent care needs after-hours includes a requirement for the creation and that under particular circumstances are often referred to a practitioner or and electronic transmission and feedback loops can be achieved through care team member who established the exchange of continuity of care oral, telephone or other less care plan or is familiar with the documents referred to as ‘‘clinical sophisticated communication methods. beneficiary. In some instances, the care summaries’’ (see Table 11 of the CY Therefore, we proposed to remove the plan does not need to be available to 2017 PFS proposed rule). We patterned requirement that the individuals address urgent patient needs after our requirements regarding clinical providing CCM after hours must have business hours. In addition, we have not summaries after the EHR Incentive access to the electronic care plan. required the use of any certified or non- Program requirement that an eligible This proposal reflected our certified health information technology professional who transitions their understanding that flexibility in how in the provision of any other PFS patient to another setting of care or practices can provide the requisite 24/ services (including various other care provider of care, or refers their patient 7 access to care, as well as continuity of management services). We were to another provider of care, should care and management of care concerned that imposing EHR-related provide a summary care record for each transitions, for their CCM patients could requirements at the service level as a transition of care or referral. This facilitate appropriate access to these condition of PFS payment could distort clinical summary includes services for Medicare beneficiaries. This the relative valuation of services priced demographics, the medication list, proposal was not intended to under the fee schedule. Therefore, we medication allergy list, problem list, and undermine the significance of proposed to change the CCM service a number of other data elements if the

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practitioner knows them. As a condition However, as we discussed above health IT systems than establishing of CCM payment, we required regarding the CCM care plan, we have code-level conditions of payment, standardized content for clinical not applied similar requirements to unique to CCM or other primary care or summaries (that they must be created/ other PFS services specifically cognitive services. We also believe that formatted according to certified EHR (including various other care a hardship, rural or small practice technology). For the exchange/transport management services) and had concerns exception would greatly increase rather function, we did not require the use of about how doing so may create than decrease administrative complexity a specific tool or service to exchange/ disparities between these services and for practitioners and CMS, and CCM transmit clinical summaries, as long as others under the PFS. We also uptake has been relatively high among they are transmitted electronically (this recognized that other CMS initiatives solo practices. We believe that reducing can include fax only when the receiving (such as MIPS and APMs under the code-level conditions of payment is practitioner or provider can only receive Quality Payment Program) may be better necessary to improve beneficiary access by fax). mechanisms to incentivize increased to appropriate CCM services. Therefore, Based on review of extensive public interoperability of health information we are finalizing revisions to the CCM comment and stakeholder feedback, we systems than conditions of payment scope of service elements as proposed. had come to believe that we should not assigned to particular services under the However, we appreciate the require the use of any specific electronic PFS. commenters’ feedback that relaxing the technology in managing a beneficiary’s Comment: Most of the commenters health IT use requirements may be of care transitions as a condition of supported our proposed revisions to the particular concern in situations where payment for CCM services. Instead, we health IT use requirements for billing CCM is outsourced to a third party, proposed more simply to require the the CCM code. They shared CMS’ goal reducing clinical integration. As we billing practitioner to create and of interoperability but believed the discuss in the section of this final rule exchange/transmit continuity of care changes were necessary to improve on BHI services (section II.E.3.b), health document(s) timely with other CCM uptake. Some commenters favored IT holds significant promise for remote practitioners and providers. To avoid hardship exceptions or rural or small connectivity and interoperability that confusion with the requirements of the practice exceptions instead of changes may assist and be useful (if not EHR Incentive Programs, and since we to the current requirements that would necessary) for reducing care would no longer require standardized apply to all practitioners alike. Some fragmentation. However, we agree that content for the CCM continuity of care commenters expressed particular remote provision of services by entities document(s), we would refer to them as concern about relaxing the current rules having only a loose association with the continuity of care documents instead of in instances where CCM outsourcing treating practitioner can detract from clinical summaries. We would no longer reduces clinical integration. These continuous, patient-centered care, specify how the billing practitioner commenters noted that CCM is whether or not those entities employ must transport or exchange these commonly outsourced to third party certified or other electronic technology. document(s), as long as it is done timely companies that provide remote care We will continue to consider the and consistent with the Care Transitions management services (including after potential impacts of remote provision of Management scope of service element. hours) via telephone and online contact CCM and similar types of services by We welcomed public input on how we only, using staff who have no third parties. We wish to emphasize for should refer to these document(s), established relationship with the CCM, as we did for BHI services, that noting that CPT does not provide model beneficiary or other members of the care while the CCM codes do not explicitly language specific to CCM services. The team and have no interaction with the count time spent by the billing proposed term ‘‘continuity of care office staff and physicians other than practitioner, they are valued to include document(s)’’ draws on CPT prefatory electronic communication. These work performed by the billing language for TCM services, which CPT commenters were concerned that our practitioner, especially complex CCM. provides may include ‘‘obtaining and proposed changes to the health IT We emphasize that the practitioner reviewing the discharge information (for requirements for CCM payment would billing for CCM must remain involved example, discharge summary, as result in little to no oversight or in ongoing oversight, management, available, or continuity of care guidance of the third party, and collaboration and reassessment as document).’’ recommended that CMS make the appropriate to bill CCM services. If there Again, this proposal was not intended proposed changes cautiously. One of is little oversight by the billing to undermine the significance of a these commenters recommended in practitioner or a lack of clinical standardized, electronic format and addition that CMS should seek to integration between a third party means of exchange (other than fax) of all increase access to CCM services and providing CCM and the billing relevant patient health information, for reduce administrative burden by practitioner, we do not believe that the achieving timely, seamless care across pursuing alignment between the CCM service elements are actually being settings especially after discharge from provision of CCM and other programs furnished and therefore, in such cases, a facility. On the contrary, we believed and incentives, such as the Quality the practitioner should not bill for CCM. that fax transmission, while commonly Payment Program. Other commenters Finally, we note that activities used, is much less efficient and secure recommended further reduction in undertaken as part of participation in than other methods of communicating payment rules, such as removing all MIPS or an APM under the Quality patient health information, and we requirements to use a certified EHR, or Payment Program may support the encourage practitioners to adopt and use movement away from timed codes that ability of a practitioner to meet our final electronic technologies other than fax require documentation in short time requirements for the continuity of care for transmission and exchange of increments and disrupt workflow. document(s) and the electronic care continuity of care documents in Response: We continue to believe that plan. providing CCM services. We continued other Medicare initiatives and programs Comment: Several commenters to believe the best means of exchange of (such as MIPS and APMs under the recommended that we define the all relevant patient health information is Quality Payment Program) are better proposed term ‘‘timely’’ for the creation through standardized electronic means. suited to advance use of interoperable and transmission of care plan and care

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transitions health information. Several practitioners’ capacity to invest in the beneficiary accepted or declined CCM commenters believed that ‘‘timely’’ best tools for managing the care of services instead of obtaining a written implies a time period of 30 to 90 days, Medicare beneficiaries. agreement. or believed some third party vendors We also proposed to remove the c. Beneficiary Receipt of Care Plan would interpret the term in this manner. language requiring beneficiary Response: Our proposal of the term We proposed to simplify the current authorization for the electronic ‘‘timely’’ originated from the use of this requirement to provide the beneficiary communication of his or her medical term in the CPT prefatory language for with a written or electronic copy of the information with other treating Care Management services, which care plan, by instead adopting the CPT providers as a condition of payment for includes, for example, ‘‘provide timely language specifying more simply that a CCM services, because under federal access and management for follow-up copy of the care plan must be given to regulations that implement the Health after an emergency department visit’’ the patient or caregiver. While we Insurance Portability and and ‘‘timely access to clinical believe beneficiaries should and must Accountability Act (HIPAA) Privacy information.’’ We do not believe we be provided a copy of the care plan, and Rule (45 CFR 164.506), a covered entity should specify a timeframe, because it that practitioners may choose to provide is permitted to use or disclose protected would vary for individual patients and the care plan in hard copy or electronic health information for purposes of CCM service elements, we are not aware form in accordance with patient treatment without patient authorization. of any clinical standards referencing preferences, we do not believe it is Moreover, if such disclosure is specific times, and we are seeking to necessary to specify the format of the electronic, the HIPAA Security Rule allow appropriate flexibility in how care plan that must be provided as a requires secure transmission (45 CFR CCM is furnished. We note that condition of CCM payment. 164.312(e)). In previous regulations we dictionary meanings of the term Additionally, we recognize that there have reminded practitioners that for all ‘‘timely’’ include quickly; soon; may be times that sharing the care plan electronic sharing of beneficiary promptly; occurring at a suitable time; with the caregiver (in a manner information in the provision of CCM done or occurring at a favorable or consistent with applicable privacy and services, HIPAA Privacy and Security useful time; opportune. ‘‘Timely’’ does security rules and regulations) may be Rule standards apply in the usual not necessarily imply speed, and means appropriate. manner (79 FR 67728). doing something at the most appropriate Comment: The commenters who Comment: The commenters were moment. Therefore we believe ‘‘timely’’ provided comments on this particular largely supportive of our proposed is an appropriate term to use to govern proposal were supportive of it. In policy changes. The commenters were how quickly the health information in particular, several commenters supportive of verbal instead of written question is transmitted or available. We expressed appreciation for appropriate beneficiary consent if a clear note that even the current requirements inclusion of caregivers. requirement remains to transparently for use of specific electronic technology Response: We thank the commenters inform the beneficiary about the nature do not necessarily impact how quickly for their support and are finalizing as and benefit of the services, applicable the health information in question is proposed. cost sharing, and document that this used to inform care, and addition of the d. Beneficiary Consent information was conveyed; current word ‘‘timely’’ implies more regarding written agreements qualify; and actual use of the information. We are We continue to believe that obtaining practitioners can elect to obtain written monitoring CCM uptake and diffusion advance beneficiary consent to receive consent. Some commenters believed through claims analysis and are CCM services is important to ensure the that obtaining written consent might be pursuing claims-based outcomes beneficiary is informed, educated about preferable as a means of resolving who analyses, to help inform whether the CCM services, and is aware of is eligible for payment, if more than one service is being provided as intended applicable cost sharing. We also believe practitioner bills. A few commenters and improving health outcomes. We that querying the beneficiary about suggested CMS require written believe these evaluation activities will whether another practitioner is already educational materials about CCM, or help us assess moving forward whether providing CCM services helps to reduce conduct beneficiary outreach and health information is being shared or the potential for duplicate provision or education. made available timely enough under our billing of the services. However, we Response: We appreciate the revised CCM payment policies. believe the consent process could be commenters’ support and As we stated in the CY 2017 proposed simplified, and that it should be left to recommendations. We are finalizing rule, the policy changes for CCM health the practitioner and the beneficiary to changes to the beneficiary consent IT use are not intended to undermine decide the best way to establish consent. requirements as proposed and clarifying the importance of interoperability or Therefore, we proposed to continue to that a clear requirement remains to electronic data exchange. These changes require billing practitioners to inform transparently inform the beneficiary are driven by concerns that we have not the beneficiary of the currently required about the nature and benefit of the applied similar requirements to other information (that is, inform the services, applicable cost sharing, and to PFS services specifically, including beneficiary of the availability of CCM document that this information was various other care management services, services; inform the beneficiary that conveyed. The final beneficiary consent and that such requirements create only one practitioner can furnish and be requirements do not affect any written disparities between CCM services and paid for these services during a calendar agreements that are already in place for other PFS services. We believe that month; and inform the beneficiary of the CCM services, and we note that other CMS initiatives may be better right to stop the CCM services at any practitioners can still elect to obtain mechanisms to incentivize increased time (effective at the end of the calendar written consent rather than verbal use and interoperability of health month)). However, we proposed to consent. information systems than conditions of specify that the practitioner could payment assigned to particular services document in the beneficiary’s medical e. Documentation under the PFS. We anticipate that these record that this information was We have heard from practitioners that CCM policy changes will improve explained and note whether the the requirements to document certain

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information in a certified EHR format regarding the patient’s psychosocial summarized in Table 11. We believe are redundant because the CCM billing needs and functional deficits. these changes will retain elements of the rules already require documentation of Comment: Many commenters were CCM service that are characteristic of core clinical information in a certified supportive of these proposals. the changes in medical practice toward EHR format. Specifically, we already Response: We thank the commenters advanced primary care, while require structured recording of for their support and are finalizing eliminating redundancy, simplifying demographics, problems, medications changes to the documentation provision of the services, and improving and medication allergies, and the requirements as proposed. We continue access to the services. For payment of creation of a clinical summary record, to encourage practitioners to utilize complex CCM services beginning in CY using a qualifying certified EHR; and health IT solutions for obtaining and 2017, we are adopting the CPT code that a full list of problems, medications documenting health information from descriptors for CPT codes 99487 and sources external to their practice, noting and medication allergies in the EHR 99489 as well as the service elements in that the 2015 edition of ONC must inform the care plan, care Table 11. We are providing separate certification criteria (see 80 FR 62601) coordination and ongoing clinical care. payment for complex CCM (CPT 99487, includes criteria which specifically Therefore, we proposed to no longer relate to obtaining information from 99489) using the RUC-recommended specify the use of a qualifying certified non-clinical sources and the capture of payment inputs for those services. We EHR to document communication to structured data relating to social, may reconsider the role of health and from home- and community-based psychological, and behavioral attributes. information technology in CCM service providers regarding the patient’s provision in future years. We anticipate psychosocial needs and functional f. Summary of Final CCM Policies that improved accuracy of payment for deficits and to document beneficiary We are finalizing changes to the CCM CCM services, and reduced consent. We would continue to require scope of service elements discussed administrative burden associated with documentation in the medical record of above that will apply for both complex billing CCM services, will contribute to beneficiary consent (discussed above) and non-complex CCM services practitioners’ capacity to invest in the and of communication to and from beginning in CY 2017. The final CY best tools for managing the care of home- and community-based providers 2017 service elements for CCM are Medicare beneficiaries.

TABLE 11—SUMMARY OF CY 2017 CHRONIC CARE MANAGEMENT SERVICE ELEMENTS AND BILLING REQUIREMENTS

Initiating Visit—Initiation during an AWV, IPPE, or face-to-face E/M visit (Level 4 or 5 visit not required), for new patients or patients not seen within 1 year prior to the commencement of chronic care management (CCM) services. Structured Recording of Patient Information Using Certified EHR Technology—Structured recording of demographics, problems, medications and medication allergies using certified EHR technology. A full list of problems, medications and medication allergies in the EHR must inform the care plan, care coordination and ongoing clinical care. 24/7 Access & Continuity of Care: • Provide 24/7 access to physicians or other qualified health care professionals or clinical staff including providing patients/caregivers with a means to make contact with health care professionals in the practice to address urgent needs regardless of the time of day or day of week. • Continuity of care with a designated member of the care team with whom the beneficiary is able to schedule successive routine appointments. Comprehensive Care Management—Care management for chronic conditions including systematic assessment of the beneficiary’s medical, functional, and psychosocial needs; system-based approaches to ensure timely receipt of all recommended preventive care services; medication reconciliation with review of adherence and potential interactions; and oversight of beneficiary self-management of medications. Comprehensive Care Plan: • Creation, revision and/or monitoring (as per code descriptors) of an electronic patient-centered care plan based on a physical, mental, cognitive, psychosocial, functional and environmental (re)assessment and an inventory of resources and supports; a comprehensive care plan for all health issues. • Must at least electronically capture care plan information, and make this information available timely within and outside the billing practice as appropriate. Share care plan information electronically (can include fax) and timely within and outside the billing practice to individuals involved in the beneficiary’s care. • A copy of the plan of care must be given to the patient and/or caregiver. Management of Care Transitions: • Management of care transitions between and among health care providers and settings, including referrals to other clinicians; follow-up after an emergency department visit; and follow-up after discharges from hospitals, skilled nursing facilities or other health care facilities. • Create and exchange/transmit continuity of care document(s) timely with other practitioners and providers. Home- and Community-Based Care Coordination: • Coordination with home and community based clinical service providers. • Communication to and from home- and community-based providers regarding the patient’s psychosocial needs and functional deficits must be documented in the patient’s medical record. Enhanced Communication Opportunities—Enhanced opportunities for the beneficiary and any caregiver to communicate with the practitioner regarding the beneficiary’s care through not only telephone access, but also through the use of secure messaging, Internet, or other asynchronous non-face-to-face consultation methods. Beneficiary Consent: • Inform the beneficiary of the availability of CCM services; that only one practitioner can furnish and be paid for these services during a calendar month; and of their right to stop the CCM services at any time (effective at the end of the calendar month). • Document in the beneficiary’s medical record that the required information was explained and whether the beneficiary accepted or declined the services. Medical Decision-Making—Complex CCM services require and include medical decision-making of moderate to high complexity (by the physician or other billing practitioner).

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5. Assessment and Care Planning for to community resources as needed (for medically necessary CCM services (CPT Patients with Cognitive Impairment example, adult day programs, support codes 99487, 99489, 99490); TCM (GPPP6) groups); care plan shared with the services (CPT codes 99495, 99496); or For CY 2017 we proposed a G-code patient and/or caregiver with initial the proposed behavioral health that would provide separate payment to education and support. integration service codes (HCPCS codes The proposed valuation of G0505 recognize the work of a physician (or GPPP1, GPPP2, GPPP3, GPPPX). (discussed in section II.E.1) assumed other appropriate billing practitioner) in Therefore, we proposed that G0505 that this code would include services could be billed on the same date-of- assessing and creating a care plan for that are personally performed by the service or within the same service beneficiaries with cognitive impairment, physician (or other appropriate billing period as these codes (CPT codes 99487, such as from Alzheimer’s disease or practitioner, such as a nurse practitioner 99489, 99490, 99495, 99496, and HCPCS dementia, at any stage of impairment, or physician assistant) and would codes GPPP1, GPPP2, GPPP3, and G0505 (Cognition and functional significantly overlap with services GPPPX). There may be overlap in the assessment using standardized described by certain E/M visit codes, patient population eligible to receive instruments with development of advance care planning services, and these services and the population recorded care plan for the patient with certain psychological or psychiatric eligible to receive the services described cognitive impairment, history obtained service codes that are currently by G0505, but we believed there would from patient and/or caregiver, in office separately payable under the PFS. be sufficient differences in the nature or other outpatient setting or home or Accordingly, we proposed that G0505 and extent of the assessments, domiciliary or rest home). We must be furnished by the physician (or interventions and care planning, as well understand that a similar code was other appropriate billing practitioner) as the qualifications of individuals recently approved by the CPT Editorial and could not be billed on the same date providing the services, to allow Panel and is scheduled to be included of service as CPT codes 90785 (Psytx concurrent billing for services that are in the CY 2018 CPT code set. We complex interactive), 90791 (Psych medically reasonable and necessary. We intended for G0505 to be a temporary diagnostic evaluation), 90792 (Psych solicited public comment on potential code, perhaps for only one year, to be diag eval w/med srvcs), 96103 (Psycho overlap between G0505 and other codes replaced by the CPT code in CT 2018. testing admin by comp), 96120 currently paid under the PFS, as well as We will consider whether to adopt and (Neuropsych tst admin w/comp), 96127 the other primary care/cognitive establish relative value units for the new (Brief emotional/behav assmt), 99201– services addressed in this section of the CPT code under our standard process, 99215 (Office/outpatient visits new), final rule. presumably for CY 2018. 99324–99337 (Domicil/r-home visits Comment: Many commenters were We reviewed the list of service new pat), 99341–99350 (Home visits supportive of the proposal, including elements that were considered by the new patient), 99366–99368 (Team conf the provisions regarding scope of CPT Editorial Panel, and proposed the w/pat by hc prof), 99497 (Advncd care service elements, conditions of following as required service elements plan 30 min), 99498 (Advncd care plan payment, and overlap with other of G0505: addl 30 min)), since these codes all services under the PFS. • Cognition-focused evaluation reflect face-to-face services furnished by Response: We thank commenters for including a pertinent history and the physician or other billing their support of the proposed scope of examination. practitioner for related separately service, conditions of payment, and • Medical decision making of billable services that overlap overlap with other services under the moderate or high complexity (defined substantially with G0505. In addition, PFS for G0505. We believe that by by the E/M guidelines). we proposed to prohibit billing of improving payment accuracy by paying • Functional assessment (for G0505 with other care planning separately for this service, practitioners example, Basic and Instrumental services, such as care plan oversight will be able to accurately assess patients Activities of Daily Living), including services (CPT code 99374), home health for cognitive impairment, particularly in decision-making capacity. care and hospice supervision (G0181, early stages. • Use of standardized instruments to G0182), or our proposed add-on code for Comment: We received numerous stage dementia. comprehensive assessment and care comments stating that assessment and • Medication reconciliation and planning by the billing practitioner for staging for dementia is very sensitive review for high-risk medications, if patients requiring CCM services and should only be conducted by applicable. (GPPP7). We solicited comment on neuropsychologists, who would be • Evaluation for neuropsychiatric and whether there are circumstances where unable to bill G0505. Commenters were behavioral symptoms, including multiple care planning codes could be concerned that untrained professionals depression, including use of furnished without significant overlap. conducting assessments for dementia standardized instrument(s). We proposed to specify that G0505 may would lead to errors in diagnosis and • Evaluation of safety (for example, serve as a companion or primary E/M inappropriate treatment. Commenters home), including motor vehicle code to the prolonged service codes encouraged CMS to not finalize this operation, if applicable. (those that are currently separately paid, code and maintain the current coding • Identification of caregiver(s), and those we proposed to separately pay for psychological and caregiver knowledge, caregiver needs, beginning in 2017), but were interested neuropsychological assessment or social supports, and the willingness of in public input on whether there is any suggested that CMS remove the bullet caregiver to take on caregiving tasks. overlap among these services. We points associated with medication • Advance care planning and solicited comment on how to best management or medical decision addressing palliative care needs, if delineate the post-service work for making so that G0505 could be billed by applicable and consistent with G0505 from the work necessary to psychologists. beneficiary preference. provide the prolonged services code. Response: While we acknowledge and • Creation of a care plan, including We did not believe the services support the work of psychologists and initial plans to address any described by G0505 would significantly neuropsychologists in the care of neuropsychiatric symptoms and referral overlap with proposed or current Medicare beneficiaries, we continue to

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believe that this code describes a including pertinent history’’ from the practitioner remain in oversight. Other distinct PFS service that may be scope of service. commenters stated that CMS should reasonable and necessary in the • Clarify that ‘‘functional assessment’’ make G0505 billable by other diagnosis and treatment of a is separate from decision making practitioners, such as occupational beneficiary’s illness. We remind assessments, and that this is a non-legal therapists, or community based entities. interested stakeholders that we assessment of competency. Response: G0505 is a service that routinely examine the valuation and • Stipulate that other decision makers includes central elements, which must coding for existing services under the should be identified. be performed by the billing practitioner potentially misvalued code initiative, • Consider deleting ‘‘use of subject to established E/M guidelines. and that there is a the process for public standardized instruments to stage Only those practitioners eligible to nomination of particular codes. If dementia’’ because the care plan is the report E/M services should report this stakeholders have information to most important aspect of the service and service. Outside of the specified suggest that the current coding for many standardized instruments are not elements, the regular incident-to rules very effective at staging. apply consistent with other E/M neuropsychological and psychological • testing is inaccurate, we welcome Clarify that the care plan address services. We believe that physicians and nominations under the established both medical and non-medical issues, eligible non-physician practitioners, process. and includes follow-up scheduling for such as a nurse practitioners and monitoring and evaluation. physician assistants should exclusively Comment: A few commenters • encouraged CMS to avoid adopting Provide a copy of the written care bill for this code. plan to the patient. Comment: Many commenters scope of service elements that are • exhaustive as these may create barriers Refer to the care plan as a ‘‘person- suggested that CMS expand HCPCS to utilization, while other commenters centered care plan.’’ code G0505 or pay separately for similar • Include evaluation of medical made the following recommendations services furnished to patients with other problems including review of lab or regarding the scope of service advanced or life threatening illnesses. imaging tests, review of co-morbidities, provisions: Response: We appreciate the • Expand scope of service elements especially those which are dependent comments on other conditions that related to medication management. on self-care, evaluation the risk of falls could benefit from assessment and care • Include occupational therapy in the and recommendations for fall planning and will consider these for scope of service element pertaining to prevention, evaluation of possible elder future rulemaking. We are finalizing the community resources. abuse, and documentation of financial G0505 code to pay separately for the • Rewrite ‘‘Creation of a care plan, issues, as part of the scope of service. assessment and care plan creation for including initial plans to address any Response: We appreciate the beneficiaries with cognitive impairment, neuropsychiatric symptoms and referral information provided by commenters on such as from Alzheimer’s disease or to community resources as needed (for the best practices associated with dementia, at any stage of impairment. example, adult day programs, support furnishing this service and would Comment: Commenters provided groups); care plan shared with the encourage stakeholders to adopt any or many examples of how CMS could patient and/or caregiver with initial all of these scope of service provisions, develop appropriate quality and education and support’’ to include such as the inclusion of caregivers in outreach measures to ensure appropriate ‘‘identification of caregiver(s), caregiver care planning. The scope of service for utilization of G0505. Commenters knowledge, caregiver needs, social assessment and care planning service encouraged CMS to closely monitor use supports, and the willingness and for patients with cognitive impairment of G0505 for a few years following availability of caregiver to voluntarily does not prohibit stakeholders from implementation, so as to ascertain take on caregiving tasks.’’ adopting any additional scope of service whether patient eligibility is an issue in • Make sure that non-paid or informal provisions which may be beneficial for uptake for the code. caregivers are included in care planning the treatment of the patient. However, Response: We appreciate the and provide resources and support for we do not believe that the ability to information on quality and outreach care givers so as to improve care givers fully furnish this service and establish measures. CMS is engaged in the use of ability to provide care for the an appropriate value for it is contingent measures to improve quality and access beneficiary. on meeting such conditions. Therefore, to care. CMS intends to monitor • Require the inclusion of caregiver we do not believe they should be added utilization and will consider how names in care plan and patients medical to the scope of service. We concur with conditions of payment align with best record, require that caregivers be commenters on the necessity of practices and quality measures. assessed for stress and depressive avoiding the imposition of overly Comment: One commenter urged symptoms, as well as care giver skill burdensome restrictions within the CMS to make the proposed coding and and education needs. scope of service. payment changes available to • State that consultations with the Comment: Some commenters physicians in total cost of care models, caregiver are permissible under HIPAA requested that CMS clarify that not all such as ACOs and bundled payment and that such conversations may be elements in the scope of service need to programs. necessary in the development of a care be provided by the billing practitioner Response: Our proposal relates only plan. and many can be provided by others to payment for services under the • Specify that any advance care incident to the billing practitioner’s Medicare PFS. We note that the codes planning is consistent with beneficiary services. One commenter stated that and payment amounts that we finalize preference and addresses any palliative there are circumstances where the best for services will be available for billing care needs of the patient, and include practitioner to provide a specific service and payment under the PFS for CY establishment of durable power of element does not work in the same 2017. In general, we do not address in attorney. practice as the billing practitioner, and this final rule, and instead defer to the • Clarify that diagnosis of dementia is therefore the billing practitioner should policies regarding billing and payment not part of the scope of service by be able to contract out for provision of for these services that are applicable deleting ‘‘cognition focused evaluation some aspects, provided that the billing within individual Center for Medicare &

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Medicaid Innovation models and other additional resources associated with commenters that the rationale for this programs. However, as our policies furnishing appropriate care to many proposal is based in large part on the regarding payment for new primary care beneficiaries with mobility-related broad use and lack of granularity in codes are applicable beginning in CY disabilities. coding for E/M services relative to other 2017, we note that models may need to When furnishing E/M services to PFS services in conjunction with the update their policies to prevent beneficiaries with mobility-related additional resources used. potential duplication of payment disabilities, practitioners face difficult We received many thoughtful between the PFS and the models. For choices in deciding whether to take the comments on this proposal and thank example, where CCM services have been extra time necessary and invest in the commenters for their input. Comments excluded from separate payment under required specialized equipment for received are summarized below. existing models, newly established care these visits even though the payment Comment: Most commenters agreed management services (including rate for the service does not account for with the proposed rule’s statement of complex CCM, psychiatric CoCM, and either expense; potentially providing disability disparities and discussed a BHI) may likewise be excluded. less than optimal care for a beneficiary variety challenges that individuals with Comment: One commenter stated that whose needs exceed the standard disabilities face in accessing the health many small practices do not have the appointment block of time in the care system. Several of these infrastructure to support a multi- standard equipped exam room reflected commenters cited evidence of existing disciplinary team of practitioners and in the current E/M visit payment rate; or challenges for individuals with urged CMS to allow flexibility for solo declining to accept appointments mobility-related disabilities, including a and small group practices to share altogether for beneficiaries who require lack of physically accessible equipment resources. The commenter also additional time and specialized within physician offices, barriers to suggested that CMS offer a one-time equipment. communication, and a lack of existing incentive for practices to integrate Each of these scenarios is potentially tools to recognize, track, and service elements into workflow. problematic. The first two scenarios consistently meet specialized needs. Response: In general, the coding under suggest that the quality of care for this Commenters applauded CMS for the PFS is intended to describe services beneficiary population might be offering a concrete proposal with as they are furnished and are valued compromised by assumptions under the significant funding to meaningfully using typical resource costs. We PFS regarding relative resource costs in address this problem and noted that 26 appreciate the concern of commenters furnishing services to this population. years after passage of the Americans regarding access, and we are eager to The third scenario reflects an obvious with Disabilities Act, it is alarming that hear from stakeholders regarding access problem for these beneficiaries. physical and communication barriers in concerns related to access for these and To improve payment accuracy and help physicians’ and other health care other PFS services. ameliorate potential disparity in access professionals’ offices still exist across and quality for beneficiaries with the country. However, some 6. Improving Payment Accuracy for Care mobility-related disabilities, we commenters suggested that the root of People With Disabilities (GDDD1) proposed to create a new add-on G- cause and scope of these issues are not We estimate that about 7 percent of all code, effective for CY 2017, to describe well characterized, and suggested that Medicare beneficiaries have a the additional services furnished in CMS work with stakeholders to conduct potentially disabling mobility-related conjunction with E/M services to additional studies and gain information diagnosis (the Medicare-only prevalence beneficiaries with disabilities that as to the underlying reasons for barriers is 5.5 percent and the prevalence for impair their mobility: to access to care and lower quality Medicare-Medicaid dual eligible G0501: Resource-intensive services scores on certain measures. beneficiaries is 11 percent), using 2010 for patients for whom the use of Generally, commenters noted that Medicare (and for dual eligible specialized mobility-assistive they appreciate CMS’ efforts to address beneficiaries, Medicaid) claims data. technology (such as adjustable height health disparities based on disability, When a beneficiary with a mobility- chairs or tables, patient lifts, and and some then supported this proposal related disability goes to a physician or adjustable padded leg supports) is as a first step in providing medically other practitioner’s office for an E/M medically necessary and used during necessary services to patients with visit, the resources associated with the provision of an office/outpatient disabilities, while others recommended providing the visit can exceed the evaluation and management service that CMS not finalize the proposal and resources required for the typical E/M visit (Add-on code, list separately in raised legal, access, and equity visit. An E/M visit for a patient with a addition to primary procedure). concerns. mobility-related disability can require Effective January 1, 2017, we Response: We agree with commenters more physician and clinical staff time to proposed that this add-on code could be that individuals with disabilities face provide appropriate care because the billed with new and established patient additional barriers to access health care, patient may require skilled assistance office/outpatient E/M codes (CPT codes an issue that contributes to widespread throughout the visit to carefully move 99201 through 99205, and 99212 disparities in outcomes. We also agree and adjust his/her body. Furthermore, through 99215), as well as transitional with commenters that the underlying an E/M visit for a patient with a care management codes (CPT codes reasons for these disparities are mobility-related disability commonly 99495 and 99496), when the additional multifaceted and can include payment requires specialized equipment such as resources described by the code are challenges, physical accessibility and a wheel chair accessible scale, floor and medically necessary and used in the communication barriers, a lack of overhead lifts, a movable exam table, provision of care. In addition to seeking awareness among health care providers padded leg supports, a stretcher and comment on this proposal, we are also in assessing and fully addressing the transfer board. The current E/M visit sought comment on other HCPCS codes needs and preferences of people with payment rates, based on an assumption that may be appropriate base codes for disabilities, and others issues. As a of ‘‘typical’’ resources involved in this proposed add-on code, including result of all these factors, individuals furnishing an E/M visit to a ‘‘typical’’ those describing preventive visits and with disabilities can face challenges in patient, do not accurately reflect these services. We reminded potential scheduling appointments, and in

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finding and maintaining a primary care relative resource costs are similarly are similar to CCM services, in that a provider, an essential foundation for systemically undervalued and we critical element of the services is non- accessing the health system. sought comment regarding other face-to-face care management/care Although there was near universal circumstances where these dynamics coordination services provided by agreement among commenters regarding can be discretely observed. clinical staff or other qualified problems in health care disparities and Comment: Multiple commenters individuals when the billing barriers to access among individuals suggested additional coding changes to practitioner may not be physically with disabilities, there was improve payment accuracy for services present. Accordingly, we proposed to disagreement about whether for people with disabilities. Several amend 42 CFR 410.26(a)(3) and establishing payment for code G0501 as commenters requested that CMS 410.26(b) to better define general proposed was a good solution to help broaden the scope of G0501 and the supervision and to assign general solve these problems. While we believe codes with which it may be billed, for supervision not only to CCM services that improving the payment accuracy of example by allowing G0501 to be billed and the non-face-to-face portion of TCM physicians’ services is necessary and with preventive services, such as the services, but also to proposed codes appropriate, and can help to address the Initial Preventive Physical Examination G0502, G0503, G0504, G0507, CPT code underlying access issues for individuals (IPPE) or ‘‘Welcome to Medicare Visit’’, 99487, and CPT code 99489. Instead of with disabilities, we also acknowledge the Annual Wellness Visit, or other adding each of these proposed codes that implementation of new or revised preventive services including those that assigned general supervision to the payments can result in unanticipated, have been assigned a grade of A or B by regulation text on an individual basis, and potentially undesirable, the United States Preventive Services we proposed to revise our regulation consequences. Before implementing Task Force. One commenter suggested under 42 CFR 410.26(b)(1) to assign payment for code G0501, we plan to that CMS also establish payment for a general supervision to the non-face-to- further analyze and address the lower-level, lower payment add-on code face portion of designated care concerns raised by commenters. As for use with patients with a mobility- management services, and we would such, we are not finalizing payment for related disability that may not require designate the applicable services code G0501 at this time. We appreciate the use of specialized equipment. through notice and comment commenters’ insights, and our Commenters also suggested that CMS rulemaking. commitment to promoting better establish certain forms of physician We did not receive any public primary care for people with disabilities payment incentives, which might more remains strong. Over the next 6 months effectively address the accessibility comments on our proposed regulation we will engage with interested needs of individuals with disabilities text. However we received a number of beneficiaries, advocates, and and ultimately reduce healthcare comments regarding a related proposal practitioners to continue to explore disparities. Specifically, one commenter to require behavioral health care improvements in payment accuracy for suggested CMS incentivize physicians managers to be located on site. Also for care of people with disabilities. We to establish record-keeping to inquire psychiatric CoCM services (G0502, intend to discuss this issue again in into patients’ accessibility and G0503 and G0504), we are finalizing a future rulemaking. accommodation needs, record the needs requirement that the behavioral health While we are not finalizing separate of their patients, and take action to meet care manager is available to perform his payment for code G0501 for CY 2017, those needs over time. or her duties face-to-face and non-face- we are including the code in the CY Response: We thank commenters for to-face with the beneficiary. We address 2017 code set as G0501. The HCPCS their thoughtful responses. We reiterate these issues at length in the BHI section code G0501 will not be payable under our commitment to addressing of this final rule (section II.E.3). Since the Medicare PFS for CY 2017, though disparities for individuals with we are assigning general supervision to practitioners will be able to report the disabilities and advancing health equity, psychiatric CoCM behavioral health care code, should they be inclined to do so. and will continue to explore and revisit manager services that may be provided potential solutions for overcoming these face-to-face with the beneficiary, we are a. Soliciting Comment on Other Coding significant challenges, including the omitting the phrase ‘‘non-face-to-face Changes To Improve Payment Accuracy appropriate changes in payment. portion of’’ in ‘‘the non-face-to-face for Care of People With Disabilities portion of designated care management When furnishing care to a beneficiary 7. Regulation Text services.’’ Accordingly, the final with a mobility-related disability, the Our current regulations in 42 CFR amended regulation text in 42 CFR current E/M visit payment rates may not 410.26(b) provide for an exception to 410.26(b) assigns general supervision to fully reflect the associated resource assign general supervision to CCM ‘‘designated care management services’’ costs that are being incurred by services (and similarly, for the non-face- that we will designate through notice practitioners. We recognize that there to-face portion of TCM services), and comment rulemaking. The services are other populations for which because these are generally non-face-to- that we are newly designating payment adjustment may be face care management/care coordination (finalizing) for general supervision in appropriate. Our proposal regarding services that would commonly be this final rule are G0502, G0503, G0504, beneficiaries with mobility-related provided by clinical staff when the G0507, CPT code 99487 and CPT code disabilities reflected the discrete nature billing practitioner (who is also the 99489. We had initially proposed of the additional resource costs for this supervising practitioner) is not adding a cross-reference to the existing population, the clear lack of physically present; and the CPT codes definition of ‘‘general supervision’’ in differentiation in resource costs are comprised solely (or in significant current regulations at § 410.32(b)(3)(i), regarding particular kinds of frequently- part) of non-face-to-face services but to better describe general furnished services, and the broad provided by clinical staff. A number of supervision in the context of these recognition of access problems. We codes that we proposed to establish for services, we are specifying at recognize that some physician practices separate payment in CY 2017 under our § 410.26(a)(3) that general supervision may frequently furnish services to initiative to improve payment accuracy means the service is furnished under the particular populations for which the for primary care and care management physician’s (or other practitioner’s)

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overall direction and control, but the requirement that CCM services be providers regarding the patient’s physician’s (or other practitioner’s) available 24/7 with health care psychosocial needs and functional presence is not required during the practitioners in the RHC or FQHC who deficits be documented in the patient’s performance of the service. At have access to the patient’s electronic medical record. This would replace the § 410.26(b)(5), we specify that, in care plan to address his or her urgent requirement to document this patient general, services and supplies must be chronic care needs, regardless of the health information in a certified EHR furnished under the direct supervision time of day or day of the week. format. of the physician (or other practitioner). • Require timely electronic sharing of We noted that we did not propose an Designated care management services care plan information within and additional payment adjustment for can be furnished under general outside the RHC or FQHC, but not patients who require extensive supervision of the physician (or other necessarily on a 24/7 basis, and expands assessment and care planning as part of practitioner) when these services or the circumstances under which the initiating visit, as payments for RHC supplies are provided incident to the transmission of the care plan by fax is and FQHC services are not adjusted for services of a physician (or other allowed. This would replace the length or complexity of the visit. practitioner). The physician (or other requirement that the electronic care We stated that we believe these practitioner) supervising the auxiliary plan be available on a 24/7 basis to all proposed changes would keep the CCM personnel need not be the same practitioners within the RHC or FQHC requirements for RHCs and FQHCs physician (or other practitioner) who is whose time counts towards the time consistent with the CCM requirements treating the patient more broadly. requirement for the practice to bill the for practitioners billing under the PFS, However, only the supervising CCM code, and removes the restriction simplify the provision of CCM services physician (or other practitioner) may on allowing the care plan to be faxed by RHCs and FQHCs, and improve bill Medicare for incident to services. only when the receiving practitioner or access to these services without provider can only receive clinical compromising quality of care, 8. CCM Requirements for Rural Health summaries by fax. Clinics (RHCs) and Federally Qualified • beneficiary privacy, or advance notice Require that in managing care and consent. Health Centers (FQHCs). transitions, the RHC or FQHC creates, We received 31 comments on the RHCs and FQHCs have been exchanges, and transmits continuity of proposed revisions to the CCM authorized to bill for CCM services since care document(s) in a timely manner requirements for RHCs and FQHCs. The January 1, 2016, and are paid based on with other practitioners and providers. following is a summary of the comments the Medicare PFS national average non- This would replace the requirements we received: facility payment rate when CPT code that clinical summaries must be created 99490 is billed alone or with other and formatted according to certified Comment: Commenters stated that payable services on a RHC or FQHC EHR technology, and the requirement they support CMS’s efforts to ensure claim. The RHC and FQHC for electronic exchange of clinical that CCM requirements for RHCs and requirements for billing CCM services summaries by a means other than fax. FQHCs are not more burdensome than have generally followed the • Require that a copy of the care plan those for practitioners billing under the requirements for practitioners billing be given to the patient or caregiver. This Medicare PFS. under the PFS, with some adaptations would remove the description of the Response: We appreciate the support based on the RHC and FQHC payment format (written or electronic) and allows of the commenters. methodologies. the care plan to be provided to the Comment: One commenter sought To assure that CCM requirements for caregiver when appropriate (and in a clarification on the requirements for RHCs and FQHCs are not more manner consistent with applicable initiating CCM with patients that have burdensome than those for practitioners privacy and security rules and been seen in the RHC within the past billing under the PFS, we proposed regulations). year. The commenter asked if CCM revisions for CCM services furnished by • Require that the RHC or FQHC could be initiated if the patient had any RHCs and FQHCs similar to the practitioner documents in the type of visit within the past year, or if revisions proposed under the section beneficiary’s medical record that all the the visit within the past year had to be above entitled, ‘‘Reducing elements of beneficiary consent (for an AWV, IPPE, or comprehensive E/M Administrative Burden and Improving example, that the beneficiary was visit. Payment Accuracy for Chronic Care informed of the availability of CCM Response: To initiate CCM with a Management (CCM) Services’’ for RHCs services; only one practitioner can patient that has been seen in the RHC and FQHCs. Specifically, we proposed furnish and be paid for these services or FQHC within the past year, an AWV, to: during a calendar month; the IPPE, or comprehensive E/M visit must • Require that CCM be initiated beneficiary may stop the CCM services have taken place within the past year in during an AWV, IPPE, or at any time, effective at the end of the the RHC or FQHC that is billing for the comprehensive E/M visit only for new calendar month, etc.) were provided, CCM service. No other type of visit patients or patients not seen within one and whether the beneficiary accepted or would meet the requirement for year. This would replace the declined CCM services. This would initiating CCM services. requirement that CCM could only be replace the requirement that RHCs and Comment: A few commenters were initiated during an AWV, IPPE, or FQHCs obtain a written agreement that concerned that RHCs and FQHCs were comprehensive E/M visit where CCM these elements were discussed, and charging beneficiaries for coinsurance services were discussed. removes the requirement that the for non-face-to-face services, and • Require 24/7 access to a RHC or beneficiary provide authorization for the recommended that the copayment be FQHC practitioner or auxiliary electronic communication of his or her waived or that CMS pursue waivers of personnel with a means to make contact medical information with other treating cost-sharing for care coordination codes. with a RHC or FQHC practitioner to providers as a condition of payment for One of these commenters stated that address urgent health care needs CCM services. patients are often unwilling to pay the regardless of the time of day or day of • Require that communication to and patient share of the CCM services since week. This would replace the from home- and community-based rural providers often have already been

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providing similar services without commenters stated that the payment management (see 42 CFR 410.144(a)(5)). additional cost to the patients. structure for RHCs and FQHCs are a DSMT services are reported under Response: As previously stated, we do disincentive to provide preventative HCPCS codes G0108 (Diabetes not have the authority to waive the services in addition to E/M services at outpatient self-management training copayment requirements for CCM the same visit. services, individual, per 30 minutes) services. While many practitioners, Response: RHCs and FQHCs are paid and G0109 (Diabetes outpatient self- including those in rural areas, have for CCM services when CPT code 99490 management training services, group always provided some care management is billed either alone or with other session (2 or more), per 30 minutes). services, we believe that payment for payable services on a RHC or FQHC The benefit, as specified at 42 CFR CCM services will enable many RHCs claim. The RHC and FQHC payment 410.141, consists of 1 hour of individual and FQHCs to furnish comprehensive structures and payment for preventive and 9 hours of group training unless and systematic care coordination services is outside the scope of this final special circumstances warrant more services that were previously rule. individual training or no group session unavailable or only sporadically offered. Comment: Several commenters is available within 2 months of the date Comment: A commenter asked for recommended that CMS provide the training is ordered. clarification on how claims for patients separate payment for psychiatric Section 1861(qq) of the Act specifies in RHCs and FQHCs with pre-existing collaborative care management services that DMST services are furnished by a care management plans should be furnished in RHCs and FQHCs, certified provider, defined as a handled, and suggested that CMS permit including CPT codes G0502, G0503, physician or other individual or entity claims for services for these patients. G0504 and G0507. The commenters that also provides, in addition to DSMT, Response: We are not entirely clear stated that allowing RHCs and FQHCs to other items or services for which what this commenter is suggesting. bill for these services will ensure that payment may be made under Medicare. RHCs and FQHCs that bill for CCM their patients who have been diagnosed The physician, individual or entity that services must develop a comprehensive with a mental health or substance use furnishes the training also must meet care plan that includes all the elements disorder have access to high-quality care certain quality standards. The previously described and also listed in tailored to their individual condition physician, individual or entity can meet Table 11. When all the requirements for and circumstances. standards established by us or standards furnishing CCM services are met, Response: To be eligible for CCM originally established by the National including the development of the services, a Medicare beneficiary must Diabetes Advisory Board and comprehensive care plan, the RHC or have two or more chronic conditions subsequently revised by organizations FQHC would submit a claim for CCM that are expected to last at least 12 who participated in their establishment, payment using CPT code 99490. Only months (or until the death of the or can be recognized by an organization the time spent furnishing CCM services patient), and place the patient at that represents individuals with after CCM is initiated with the patient significant risk of death, acute diabetes as meeting standards for is counted toward the minimum 20 exacerbation/decompensation, or furnishing the services. minutes required for CCM billing. There functional decline. While CCM is We require that all those who furnish is no additional payment for a pre- typically associated with primary care DSMT services be accredited as meeting existing care plan, and if a conditions, patient eligibility is quality standards by a CMS-approved comprehensive care plan that meets the determined by the RHC or FQHC national accreditation organization CCM requirements was developed practitioner, and mental health (NAO). In accordance with § 410.144, a before the initiation of CCM services, conditions are not excluded. We invite CMS-approved NAO may accredit an the time spent developing the plan comments on whether an additional individual, physician or entity to meet would not be counted toward the 20 code specifically for mental health one of three sets of DSMT quality minute minimum requirement. conditions is necessary for RHCs and standards: CMS quality standards; the Comment: A few commenters FQHCs that want to include National Standards for Diabetes Self- requested clarification on whether RHCs beneficiaries with mental health Management Education Programs and FQHCs could bill the new CCM conditions in their CCM services. (National Standards); or the standards of codes for either complex CCM services After considering the comments, we an NAO that represents individuals (CPT 99487 and 99489) or the separately are finalizing as proposed the revisions with diabetes that meet or exceed our billable comprehensive CCM assessment to the requirements for CCM services quality standards. Currently, we and care planning (G0506). furnished by RHCs and FQHCs. recognize the American Diabetes Response: As we noted in the Association and the American F. Improving Payment Accuracy for proposed rule, we did not propose to Association of Diabetes Educators as Services: Diabetes Self-Management adopt codes to provide for an additional approved NAOs, both of whom follow Training (DSMT) payment for patients who require National Standards. Medicare payment extensive assessment or care planning Section 1861(s)(2)(S) of the Act for outpatient DSMT services is made in because payments for RHC and FQHC specifies that medical and other health accordance with 42 CFR 414.63. services are not adjusted for the length services include DSMT services as An article titled ‘‘Use of Medicare’s or complexity of the visit. Therefore, the defined in section 1861(qq) of the Act. Diabetes Self-Management Training codes identified by the commenters are DSMT services are intended to educate Benefit’’ was published in Health not separately billable by an RHC or beneficiaries in the successful self- Education Behavior on January 23, FQHC. management of diabetes. DSMT 2015. The article noted that only 5 Comment: A few commenters includes, as applicable, instructions in percent of Medicare beneficiaries with recommended that CMS allow RHCs self-monitoring of blood glucose; newly diagnosed diabetes used DSMT and FQHCs to bill for the new CCM education about diet and exercise; an services. The article recommended that codes, and to allow safety net providers insulin treatment plan developed future research identify barriers to to bill for preventive services in specifically for the patient who is DSMT access. addition to the all-inclusive rate for insulin-dependent; and motivation for In the CY 2017 PFS proposed rule (81 RHCs and the PPS rate for FQHCs. The patients to use the new skills for self- FR 45215), we identified issues that the

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DSMT community had brought to our by which such reduced expenditures For recent years, interim final values attention which may contribute to the exceeds the target for a given year shall for misvalued codes (year 2) have low utilization of these services, and be treated as a net reduction in generally reflected reductions relative to indicated that we plan to address and expenditures for the succeeding year, original values (year 1), and for most clarify those issues through Medicare for purposes of determining whether the codes, the interim final values (year 2) program instructions as appropriate. We target has been met for that subsequent are maintained and finalized (year 3). also solicited public comment as to year. Section 1848(c)(2)(O)(iv) of the Act However, when values for particular other access barriers—including defines a target recapture amount as the codes have changed between the interim whether Medicare payment for these difference between the target for the final (year 2) and final values (year 3) services is accurate—to help us identify year and the estimated net reduction in based on public comment, the general and address them. We appreciate the expenditures under the PFS resulting tendency has been that codes increase many comments regarding many issues from adjustments to RVUs for misvalued in the final value (year 3) relative to the in response to our solicitation. codes. Section 1848(c)(2)(O)(iii) of the interim final value (year 2), even in Comment: Many commenters stated Act specifies that, if the estimated net cases where the final value (year 3) that the payment rates were too low but reduction in PFS expenditures for the represents a decrease from the original did not suggest specific changes in the year is less than the target for the year, value (year 1). Therefore, for these inputs used to develop payment rates an amount equal to the target recapture codes, the year 2 changes compared to under the PFS for particular services amount shall not be taken into account year 1 would risk over-representing the (specifically, work RVUs and direct PE when applying the budget neutrality overall reduction, while the year 3 to inputs). We also received additional requirements specified in section year 2 changes would represent an comments identifying multiple other 1848(c)(2)(B)(ii)(II) of the Act. Under increase in value. We noted that if there possible barriers to access. These section 1848(c)(2)(O)(v) of the Act, the were similar targets in every PFS year, commenters’ recommendations target that applies to calendar years and a similar number of misvalued code primarily addressed issues related to (CYs) 2017 and 2018 is calculated as 0.5 changes made on an interim final basis, regulatory and statutory DSMT percent of the estimated amount of the incongruence in measuring what is requirements, such as: (a) Expanding of expenditures under the PFS for the year. really a 3-year change in 2-year the definition of diabetes to include In CY 2016 PFS rulemaking, we increments might not be particularly hemoglobin A1C as one of the criteria proposed and finalized a methodology problematic since each year’s for diagnosing diabetes; (b) modifying to implement this statutory provision. calculation would presumably include a the definition of certified provider to Because the annual target is similar number of codes measured include the certified diabetes educator calculated by measuring changes from between years 1 and 2 and years 2 and (CDE) to permit them to bill for DSMT; one year to the next, for CY 2016, we 3. (c) allowing physicians and NPPs, other considered how to account for changes However, including changes that take than the one treating the beneficiary’s in values that are best measured over 3 place over 3 years generated challenges diabetes, as required by regulation, to years, instead of 2 years. As we in calculating the target for CY 2016. order DSMT services; and, (d) described in the CY 2016 final rule with Because there was no target for CY 2015, eliminating the copays and deductible comment period (80 FR 70932), our any reductions that occurred on an for DSMT services. general valuation process for potentially interim final basis for CY 2015 were not Response: We appreciate the misvalued, new, and revised codes was counted toward achievement of a target. comments received and will consider to establish values on an interim final If we had then included any upward changes in valuation of these services basis for a year in the PFS final rule adjustments made to these codes based and other regulatory issues raised by with comment period. Then, during the on public comment as ‘‘misvalued commenters for future rulemaking. We 60-day period following the publication code’’ changes for CY 2016, we would also appreciate commenters’ feedback of the final rule with comment period, effectively be counting the service-level on several subregulatory guidelines and we would accept public comment about increases for 2016 (year 3) relative to other operational issues that we will those valuations. In the final rule with 2015 (year 2) against achievement of the consider addressing outside of comment period for the subsequent target without any consideration to the rulemaking. year, we would consider and respond to service-level changes relative to 2014 public comments received on the G. Target for Relative Value (year 1), even in cases where the overall interim final values, and make any Adjustments for Misvalued Services change in valuation was negative. appropriate adjustments to values based Therefore, we proposed and finalized Section 1848(c)(2)(O) of the Act on those comments. Under that process the decision to exclude code-level input establishes an annual target for for revaluing new, revised, and changes for CY 2015 interim final values reductions in PFS expenditures misvalued codes, we believe the overall from the calculation of the CY 2016 resulting from adjustments to relative change in valuation for many codes misvalued code target since the values of misvalued codes. Under would best be measured across values misvalued change occurred over section 1848(c)(2)(O)(ii) of the Act, if the for 3 years: between the original value multiple years, including years not estimated net reduction in expenditures in the first year; the interim final value applicable to the misvalued code target for a year as a result of adjustments to in the second year; and the finalized provision. the relative values for misvalued codes value in the third year. However, the For the CY 2017 final rule, we will be is equal to or greater than the target for target calculation for a year would only finalizing values (year 3) for codes that that year, reduced expenditures be comparing changes in RVUs between were interim final in CY 2016 (year 2). attributable to such adjustments shall be 2 years and not among 3 years, so the Unlike codes that were interim final for redistributed in a budget-neutral contribution of a particular change CY 2015, the codes that are interim final manner within the PFS in accordance towards the target for any single year for CY 2016 were included as misvalued with the existing budget neutrality would be measured against only the codes and will fall within the range of requirement under section preceding year without regard to the years for which the misvalued code 1848(c)(2)(B)(ii)(II) of the Act. The overall change that takes place over 3 target provision applies. Thus, overall provision also specifies that the amount years. changes in values for these codes would

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be measured in the target across 3 full Comment: Several commenters To determine which services are years: The original value in the first year expressed support for the CMS estimate described by new or revised codes for (CY 2015); the interim final value in the that there would be no target recapture purposes of the phase-in provision, we second year (CY 2016); and the finalized amount by which to reduce payments apply the phase-in to all services that value in the third year (CY 2017). The made under the PFS in CY 2017. are described by the same, unrevised changes in valuation for these CY 2016 Response: We appreciate the code in both the current and update interim final codes were previously comments. We remind stakeholders that year, and exclude codes that describe measured and counted towards the the final determination of the target different services in the current and target during their initial change in recapture amount is based on finalized update year. valuation between years 1 and 2. RVUs for the relevant codes. We refer Because the phase-in of significant As such, we proposed to include readers to the regulatory impact analysis reductions in RVUs falls within the changes in values of the CY 2016 section of this final rule for the net budget neutrality requirements specified interim final codes toward the CY 2017 reduction in expenditures relative to the in section 1848(c)(2)(B)(ii)(II) of the Act, misvalued code target. We believe that 0.5 percent target for CY 2017, and the we estimate the total RVUs for a service this is consistent with the approach that resulting adjustment that is required to prior to the budget-neutrality we finalized in the CY 2016 PFS final be made to the conversion factor. redistributions that result from rule with comment period. The changes Comment: One commenter urged implementing phase-in values. In in values of CY 2015 interim final codes CMS to broaden its approach to implementing the phase-in, we consider were not counted towards the counting misvalued code payment a 19 percent reduction as the maximum misvalued code target in CY 2016 since adjustments in the final rule. The 1-year reduction for any service not the valuation change occurred over commenter stated that CMS was taking described by a new or revised code. multiple years, including years not a narrow approach to the misvalued This approach limits the year one applicable to the misvalued code target code target. reduction for the service to the provision. However, both of the changes Response: We finalized our maximum allowed amount (that is, 19 in valuation for the CY 2016 interim methodology for calculating the percent), and then phases in the final codes, from year 1 to year 2 (CY estimated net reduction relative to the remainder of the reduction. 2015 to CY 2016) and from year 2 to misvalued code target in the CY 2016 The statute provides that the year 3 (CY 2016 to CY 2017), have taken final rule with comment period (80 FR applicable adjustments in work, PE, and place during years that occur within the 70921–70927). For CY 2017, we MP RVUs shall be phased in over a 2- misvalued code target provision. We proposed a modification to that year period when the RVU reduction for therefore believe that any adjustments methodology that only addressed how a code for a year is estimated to be equal made to these codes based on public changes to interim final codes would be to or greater than 20 percent. Since CY comment should be considered towards addressed when both first and second 2016 was the first year in which we the achievement of the target for CY year changes could be counted towards applied the phase-in transition, CY 2017 2017, just as any changes in valuation a misvalued code target since CY 2017 will be the first year in which a single for these same CY 2016 interim final is the first year for that circumstance. code could be subject to RVU reductions codes previously counted towards the We did not make a proposal on the more greater than 20 percent for 2 consecutive achievement of the target for CY 2016. general issue of the methodology used years. We solicited comments regarding this to calculate the net reductions for the Under our finalized policy, the only proposal. We also reminded misvalued code target, which, as noted codes that are not subject to the phase- commenters that we revised our process above, was finalized in the CY 2016 PFS in are those that are new or revised, for revaluing new, revised and final rule with comment period. which we defined as those services that misvalued codes so that we will be We did not receive any public are not described by the same, proposing and finalizing values for most comments on our proposal to include unrevised code in both the current and of the misvalued codes during a single changes in values of the CY 2016 update year, or by the same codes that calendar year. After this year, there will interim final codes toward the CY 2017 describe different services in the current be far fewer instances of interim final misvalued code target. and update year. Since CY 2016 was the codes and changes that are best After consideration of comments first year for which the phase-in measured over 3 years. received, we are finalizing our proposal provision applied, we did not address We refer readers to the regulatory to count any adjustments to interim how we would handle codes with impact analysis section of this final rule final codes towards the misvalued code values that had been partially phased in for the net reduction in expenditures target when both first and second year during the first year, but that have a relative to the 0.5 percent target for CY changes can be counted towards a remaining phase-in reduction of 20 2017, and the resulting adjustment misvalued codes target. percent or greater. required to be made to the conversion The significant majority of codes with factor. Additionally, we refer readers to H. Phase-In of Significant RVU reductions in RVUs that are greater than the public use file that provides a Reductions 20 percent in year one would not be comprehensive description of how the Section 1848(c)(7) of the Act specifies likely to meet the 20 percent threshold target is calculated, as well as the that for services that are not new or in a consecutive year. However, in a few estimated impact by code family on the revised codes, if the total RVUs for a cases, significant changes (for example, CMS Web site under the supporting data service for a year would otherwise be in the input costs included in the files for the CY 2017 PFS final rule at decreased by an estimated 20 percent or valuation of a service) could produce http://www.cms.gov/Medicare/ more as compared to the total RVUs for reductions of 20 percent or greater in Medicare-Fee-for-Service-Payment/ the previous year, the applicable consecutive years. PhysicianFeeSched/index.html. adjustments in work, PE, and MP RVUs As stated in the CY 2017 PFS The following is summary of the shall be phased in over a 2-year period. proposed rule, we believed that a comments we received regarding the In the CY 2016 PFS rulemaking, we consistent methodology regarding the target for relative value adjustments for proposed and finalized a methodology phase-in transition should be applied to misvalued services. to implement this statutory provision. these cases. We proposed to reconsider

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in each year, for all codes that are not Comment: One commenter objected to Comment: One commenter opposed new or revised codes and including CMS’ decision to exclude from the the phase-in proposal. The commenter codes that were assigned a phase-in phase-in codes with a reduction of 20 stated that the proposal twisted a plain value in the previous year, whether the percent or more that fall within a family reading of the law to effectively extend total RVUs for the service would with significant coding revisions. The the phase-in period well beyond the 2 otherwise be decreased by an estimated commenter requested that CMS years prescribed by the statute. The 20 percent or more as compared to the reconsider this policy. commenter questioned why Medicare total RVUs for the previous year. Under Response: We understand the beneficiaries should have to pay a this proposed policy, the 19 percent commenters’ concerns. In the CY 2016 higher fee for overvalued services when reduction in total RVUs would continue final rule with comment period (80 FR identified as such, and pointed out that to be the maximum one-year reduction 70927–70931), we finalized a policy to in the budget-neutral environment of for all codes (except those considered identify services that are not subject to the fee schedule, the proposal would new and revised), including those codes the phase-in because they are new or delay the benefit of these RVU with phase-in values in the previous revised codes. As we wrote at the time, reductions to the rest of the services year. In other words, for purposes of the we excluded as new and revised codes listed in the PFS. 20 percent threshold, every service is those codes that describe a different set Response: We appreciate the concerns evaluated anew each year, and any of services in the update year when raised by the commenter. As we have applicable phase-in is limited to a compared to the current year by virtue addressed over several rulemaking decrease of 19 percent. For example, if of changes in other, related codes, or cycles, we are concerned about the we were to adopt a 50 percent reduction codes that are part of a family with impact of misvalued services in creating in total RVUs for an individual service, significant coding revisions. Significant distortions in relativity across the fee the reduction in any particular year coding revisions within a family of schedule. However, we have already would be limited to a decrease of 19 codes can change the relationships finalized through notice and comment percent in total RVUs. Because we do among codes to the extent that it rulemaking and continue to believe that not set rates 2 years in advance, the changes the way that all services in the limiting reductions to 19 percent as the phase-in transition would continue to group are reported, even if some maximum 1-year decrease for all codes apply until the year-to-year reduction individual codes retain the same (except those considered new and for a given code does not meet the 20 number or, in some cases, the same revised) is the best and most fair way to percent threshold. We solicited descriptor. We continue to believe that apply the phase-in. Additionally, comments regarding this proposal. this is the most accurate methodology to because we do not set rates 2 years in The list of codes subject to the phase- use in identifying new and revised advance, we believe there are significant in and the associated proposed RVUs codes for the purposes of the phase-in obstacles to implementing an alternative that result from this methodology is transition. We also note that we did not methodology. For example, codes may available on the CMS Web site under make a proposal to change how we be reviewed multiple times in a short downloads for the CY 2017 PFS final identify services to which the phase-in period of time, and may have further rule at http://www.cms.gov/Medicare/ does not apply. decreases in total RVUs for a subsequent Medicare-Fee-for-Service-Payment/ Comment: A commenter requested year due to a variety of reasons in PhysicianFeeSched/PFS-Federal- that CMS apply the phase-in policy to addition to any change inputs from the Regulation-Notices.html. services in the PFS with year-to-year initial year phase-in. These might The following is summary of the reductions of 20 percent or more in include supply and equipment price comments we received regarding the payment amount due to the statutory updates in non-reviewed years, phase-in of significant RVU reductions. cap that requires payment for the significant changes in specialty mix of Comment: Many commenters technical component (TC) of certain practitioners reporting the service, or supported the proposal that a 19 percent imaging services furnished in the office changes in other PFS ratesetting policies reduction in total RVUs would continue setting to be made the lesser of the PFS which could lead to several consecutive to be the maximum one-year reduction or OPPS rates. The commenter stated years of RVU reductions. In any such for all codes that are not new or revised. that this application would capture the cases, it would be impractical to These commenters urged CMS to spirit of the phase-in legislation in identify with certainty what portion of finalize the proposal. dampening the impact of significant reductions in code values are due to Response: We appreciate the support payment reductions on a year to year input changes established in a prior year from the commenters. basis. versus input or policy changes from the Comment: Several commenters Response: Section 1848(c)(7) of the current year. We also note that all of suggested that CMS should extend the Act requires the phase-in of reductions these circumstances are relatively rare threshold for triggering the phase-in of 20 percent or more in the total RVUs since it is unusual for changes in code provision, by using a lower single-year for individual services. The OPPS cap, inputs to result in reductions of greater maximum reduction (such as 10 required under section 1848(b)(4)(A) of than 40 percent. Therefore, while we percent), at a rate different than what the Act, specifies that if the PFS appreciate the importance of improving the statute stipulates. The commenters payment rate for the TC of certain payment accuracy as soon as can be stated that a lower threshold would imaging services exceeds the OPPS practicable for the reasons stated by the provide a greater safeguard against payment amount for the services, the commenter, we also believe that, on payment cuts and disruption of services. OPPS payment amount must be balance, the best and most fair approach Response: Section 1848(c)(7) of the substituted for the PFS TC payment to implementing the required phase-in Act requires the phase-in if the total amount. The OPPS cap refers to, and of RVU reductions over multiple years RVUs for a service for a year would requires substitution of, payment rates is to re-examine eligible codes for the otherwise be decreased by an estimated for individual imaging services, and not phase-in on an annual basis, in 20 percent or larger. We do not believe a reduction in the total RVUs for those conjunction with our annual ratesetting. that we have the statutory authority to services. As such, services that are After consideration of comments establish a different threshold value for subject to the OPPS cap are not subject received, we are finalizing the policy as when the phase-in applies. to the phase-in on that basis. proposed.

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I. Geographic Practice Cost Indices RVUs for the service differ from those of the adjustment since Medicare (GPCIs) the GAF. payments typically contribute to or As noted above, section 201 of the influence physician wages. That is, 1. Background MACRA extended the 1.0 work GPCI including physicians’ wages in the Section 1848(e)(1)(A) of the Act floor for services furnished through physician work GPCIs would, in effect, requires us to develop separate December 31, 2017. Therefore, the make the indices, to some extent, Geographic Practice Cost Indices proposed CY 2017 work GPCIs and dependent upon Medicare payments. (GPCIs) to measure relative cost summarized GAFs reflect the 1.0 work The work GPCI updates in CYs 2001, differences among localities compared floor. Additionally, as required by 2003, 2005, and 2008 were based on to the national average for each of the sections 1848(e)(1)(G) and 1848(e)(1)(I) professional earnings data from the 2000 three fee schedule components (that is, of the Act, the 1.5 work GPCI floor for Census. However, for the CY 2011 GPCI work, PE, and malpractice (MP)). The Alaska and the 1.0 PE GPCI floor for update (75 FR 73252), the 2000 data PFS localities are discussed in section frontier states are permanent, and were outdated and wage and earnings II.E.3. of this final rule. Although the therefore, applicable in CY 2017. See data were not available from the more statute requires that the PE and MP Addenda D and E to this final rule for recent Census because the ‘‘long form’’ GPCIs reflect the full relative cost the CY 2017 GPCIs and summarized was discontinued. Therefore, we used differences, section 1848(e)(1)(A)(iii) of GAFs available on the CMS Web site the median hourly earnings from the the Act requires that the work GPCIs under the supporting documents section 2006 through 2008 Bureau of Labor reflect only one-quarter of the relative of the CY 2017 PFS final rule located at Statistics (BLS) Occupational cost differences compared to the https://www.cms.gov/Medicare/ Employment Statistics (OES) wage data national average. In addition, section Medicare-Fee-for-Service-Payment/ as a replacement for the 2000 Census 1848(e)(1)(G) of the Act sets a PhysicianFeeSched/index.html. data. The BLS OES data meet several permanent 1.5 work GPCI floor for criteria that we consider to be important 2. GPCI Update services furnished in Alaska beginning for selecting a data source for purposes January 1, 2009, and section The proposed updated GPCI values of calculating the GPCIs. For example, 1848(e)(1)(I) of the Act sets a permanent were calculated by a contractor. There the BLS OES wage and employment 1.0 PE GPCI floor for services furnished are three GPCIs (work, PE, and MP), and data are derived from a large sample in frontier states (as defined in section all GPCIs are calculated relative to the size of approximately 200,000 1848(e)(1)(I) of the Act) beginning national average for each measure. establishments of varying sizes January 1, 2011. Additionally, section Additionally, each of the three GPCIs nationwide from every metropolitan 1848(e)(1)(E) of the Act provided for a relies on its own data source(s) and area and can be easily accessible to the 1.0 floor for the work GPCIs, which was methodology for calculating its value as public at no cost. Additionally, the BLS set to expire on March 31, 2015. Section described below. Additional OES is updated regularly, and includes 201 of the MACRA amended the statute information on the CY 2017 GPCI a comprehensive set of occupations and to extend the 1.0 floor for the work update may be found in our contractor’s industries (for example, 800 GPCIs through CY 2017 (that is, for draft report, ‘‘Draft Report on the CY occupations in 450 industries). For the services furnished no later than 2017 Update of the Geographic Practice CY 2014 GPCI update, we used updated December 31, 2017). Cost Index for the Medicare Physician BLS OES data (2009 through 2011) as a Section 1848(e)(1)(C) of the Act Fee Schedule,’’ which is available on replacement for the 2006 through 2008 requires us to review and, if necessary, our Web site. It is located under the data to compute the work GPCIs. adjust the GPCIs at least every 3 years. supporting documents section for the Because of its reliability, public Section 1848(e)(1)(C) of the Act requires CY 2017 PFS final rule located at availability, level of detail, and national that, if more than 1 year has elapsed https://www.cms.gov/Medicare/ scope, we believe the BLS OES data since the date of the last previous GPCI Medicare-Fee-for-Service-Payment/ continue to be the most appropriate adjustment, the adjustment to be PhysicianFeeSched/index.html. source of wage and employment data for applied in the first year of the next use in calculating the work GPCIs (and adjustment shall be half of the a. Work GPCIs as discussed in section II.E.2.b the adjustment that otherwise would be The work GPCIs are designed to employee wage component and made. Therefore, since the previous reflect the relative costs of physician purchased services component of the PE GPCI update was implemented in CY labor by Medicare PFS locality. As GPCI). Therefore, for the proposed CY 2014 and CY 2015, we proposed to required by statute, the work GPCI 2017 GPCI update, we used updated phase in 1/2 of the latest GPCI reflects one quarter of the relative wage BLS OES data (2011 through 2014) as a adjustment in CY 2017. differences for each locality compared replacement for the 2009 through 2011 We have completed a review of the to the national average. data to compute the work GPCIs. GPCIs and proposed new GPCIs in this To calculate the work GPCIs, we use final rule. We also calculate a wage data for seven professional b. Practice Expense GPCIs geographic adjustment factor (GAF) for specialty occupation categories, The PE GPCIs are designed to measure each PFS locality. The GAFs are a adjusted to reflect one-quarter of the the relative cost difference in the mix of weighted composite of each area’s work, relative cost differences for each locality goods and services comprising practice PE and malpractice expense GPCIs compared to the national average, as a expenses (not including malpractice using the national GPCI cost share proxy for physicians’ wages. Physicians’ expenses) among the PFS localities as weights. While we do not actually use wages are not included in the compared to the national average of GAFs in computing the fee schedule occupation categories used in these costs. Whereas the physician work payment for a specific service, they are calculating the work GPCI because GPCIs (and as discussed later in this useful in comparing overall areas costs Medicare payments are a key section, the MP GPCIs) are comprised of and payments. The actual effect on determinant of physicians’ earnings. a single index, the PE GPCIs are payment for any actual service would Including physician wage data in comprised of four component indices deviate from the GAF to the extent that calculating the work GPCIs would (employee wages; purchased services; the proportions of work, PE and MP potentially introduce some circularity to office rent; and equipment, supplies and

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other miscellaneous expenses). The services furnished during the policy 50161). There are no changes in the employee wage index component term). For the CY 2014 GPCI update states identified as Frontier States for measures geographic variation in the (seventh update) we used 2011 and the CY 2017 final rule. The qualifying cost of the kinds of skilled and 2012 malpractice premium data (78 FR states are: Montana, Wyoming, North unskilled labor that would be directly 74382). The proposed CY 2017 MP GPCI Dakota, South Dakota, and Nevada. In employed by a physician practice. update reflects 2014 and 2015 premium accordance with statute, we would Although the employee wage index data. Additionally, the proposed CY apply a 1.0 PE GPCI floor for these states adjusts for geographic variation in the 2017 MP GPCI update reflects several in CY 2017. cost of labor employed directly by proposed technical refinements to the physician practices, it does not account MP GPCI methodology as discussed f. Proposed GPCI Update for geographic variation in the cost of later in section 5. As explained above in the background services that typically would be section, the periodic review and d. GPCI Cost Share Weights purchased from other entities, such as adjustment of GPCIs is mandated by law firms, accounting firms, information For CY 2017 GPCIs, we proposed to section 1848(e)(1)(C) of the Act. At each technology consultants, building service continue to use the current cost share update, the proposed GPCIs are managers, or any other third-party weights for determining the PE GPCI published in the PFS proposed rule to vendor. The purchased services index values and locality GAFs. We refer provide an opportunity for public component of the PE GPCI (which is a readers to the CY 2014 PFS final rule comment and further revisions in separate index from employee wages) with comment period (78 FR 74382 response to comments prior to measures geographic variation in the through 74383), for further discussion implementation. As discussed later in cost of contracted services that regarding the 2006-based MEI cost share this section, we are finalizing the GPCIs physician practices would typically weights revised in CY 2014 that were as proposed (except where we correct buy. (For more information on the also finalized for use in the CY 2014 technical errors). The final CY 2017 development of the purchased service (seventh) GPCI update. updated GPCIs for the first and second index, we refer readers to the CY 2012 The GPCI cost share weights for CY year of the 2-year transition, along with PFS final rule with comment period (76 2017 are displayed in Table 12. the GAFs, are displayed in Addenda D FR 73084 through 73085)). The office and E to this final rule available on our rent index component of the PE GPCI TABLE 12—COST SHARE WEIGHTS Web site under the supporting measures relative geographic variation FOR CY 2017 GPCI UPDATE documents section of the CY 2017 PFS in the cost of typical physician office final rule Web page at https:// rents. For the medical equipment, Proposed Current CY 2017 www.cms.gov/Medicare/Medicare-Fee- supplies, and miscellaneous expenses cost cost for-Service-Payment/ component, we believe there is a Expense category share weight share PhysicianFeeSched/index.html. national market for these items such (%) weight that there is not significant geographic (%) 3. Payment Locality Discussion variation in costs. Therefore, the Work ...... 50.866 50.866 a. Background equipment, supplies and other Practice Expense ...... 44.839 44.839 The current PFS locality structure was miscellaneous expense cost index —Employee Com- component of the PE GPCI is given a developed and implemented in 1997. pensation ...... 16.553 16.553 There are currently 89 total PFS value of 1.000 for each PFS locality. —Office Rent ...... 10.223 10.223 For the previous update to the GPCIs —Purchased Serv- localities; 34 localities are statewide (implemented in CY 2014) we used ices ...... 8.095 8.095 areas (that is, only one locality for the 2009 through 2011 BLS OES data to —Equipment, Sup- entire state). There are 52 localities in calculate the employee wage and plies, Other ...... 9.968 9.968 the other 16 states, with 10 states having purchased services indices for the PE Malpractice Insurance 4.295 4.295 2 localities, 2 states having 3 localities, 1 state having 4 localities, and 3 states GPCI. As discussed in section II.E.2.a., Total ...... 100.000 100.000 because of its reliability, public having 5 or more localities. The combined District of Columbia, availability, level of detail, and national e. PE GPCI Floor for Frontier States scope, we continue to believe the BLS Maryland, and Virginia suburbs; Puerto OES is the most appropriate data source Section 10324(c) of the Affordable Rico; and the Virgin Islands are the for collecting wage and employment Care Act added a new subparagraph (I) remaining three localities of the total of data. Therefore, in calculating the under section 1848(e)(1) of the Act to 89 localities. The development of the proposed CY 2017 GPCI update, we establish a 1.0 PE GPCI floor for current locality structure is described in used updated BLS OES data (2011 physicians’ services furnished in detail in the CY 1997 PFS final rule (61 through 2014) as a replacement for the frontier states effective January 1, 2011. FR 34615) and the subsequent final rule 2009 through 2011 data for purposes of In accordance with section 1848(e)(1)(I) with comment period (61 FR 59494). We calculating the employee wage of the Act, beginning in CY 2011, we note that the localities generally component and purchased service index applied a 1.0 PE GPCI floor for represent a grouping of one or more component of the PE GPCI. physicians’ services furnished in states constituent counties. determined to be frontier states. In Prior to 1992, Medicare payments for c. Malpractice Expense (MP) GPCIs general, a frontier state is one in which physicians’ services were made under The MP GPCIs measure the relative at least 50 percent of the counties are the reasonable charge system. Payments cost differences among PFS localities for ‘‘frontier counties,’’ which are those that were based on the charging patterns of the purchase of professional liability have a population per square mile of physicians. This resulted in large insurance (PLI). The MP GPCIs are less than 6. For more information on the differences in payment for physicians’ calculated based on insurer rate filings criteria used to define a frontier state, services among types of services, of premium data for $1 million to $3 we refer readers to the FY 2011 geographic payment areas, and million mature claims-made policies Inpatient Prospective Payment System physician specialties. Recognizing this, (policies for claims made rather than (IPPS) final rule (75 FR 50160 through the Congress replaced the reasonable

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charge system with the Medicare PFS in 1886(d)(3)(E) (IPPS wage index) of the Comment: Several commenters stated the Omnibus Budget Reconciliation Act Act. their objection to the use of residential (OBRA) of 1989, and the PFS went into The following is a summary of the rents as a proxy for physician office effect January 1, 1992. Payments under comments we received regarding the space costs, and stated that CMS should the PFS are based on the relative proposed CY 2017 GPCI update. collect commercial rent data and use it resources involved with furnishing Comment: A few commenters either as the basis for measuring services, and are adjusted to account for including a major specialty society geographic differences in physician geographic variations in resource costs expressed support for using more office rents or, if this is not feasible, use as measured by the GPCIs. current data in calculating all three it to validate the residential rents as a Payment localities originally were GPCIs. proxy. A few commenters requested that established under the reasonable charge Response: We thank the commenters CMS provide a specific explanation on system by local Medicare carriers based for their support. the barriers to gaining better commercial on their knowledge of local physician Comment: One commenter expressed rent data. support for the elimination of all charging patterns and economic Response: Because Medicare is a conditions. These localities changed geographic adjustment factors under the PFS, except those designed to achieve a national program, and section little between the inception of Medicare 1848(e)(1)(A) of the Act requires us to in 1967 and the beginning of the PFS in specific public policy goal, such as to encourage physicians to practice in establish GPCIs to measure relative cost 1992. Shortly after the PFS took effect, differences among localities compared we undertook a study in 1994 that underserved areas. Another commenter opposed any decrease in the GPCI. to the national average, we believe it is culminated in a comprehensive locality important to use the best data that is revision that was implemented in 1997 Response: As previously discussed, available on a nationwide basis, that is (61 FR 59494). section 1848(e)(1)(A) of the Act requires regularly updated, and retains The revised locality structure reduced us to develop separate GPCIs to measure the number of localities from 210 to the resource cost differences among consistency area-to-area, year-to-year. current 89, and the number of statewide localities compared to the national Since there is currently no national data localities increased from 22 to 34. The average for each of the three GPCI source available for physician office or revised localities were based on locality components, and section 1848(e)(1)(C) other comparable commercial rents, we resource cost differences as reflected by of the Act requires us to review and, if continue to use county-level residential the GPCIs. For a full discussion of the necessary, adjust the GPCIs at least rent data from the American methodology, see the CY 1997 PFS final every 3 years; and based on new data, Community Survey (ACS) as a proxy for rule with comment period (61 FR GPCI values may increase or decrease. the relative cost differences in 59494). The current 89 fee schedule Comment: A few commenters commercial office rents. The ACS is areas are defined alternatively by state expressed concern regarding payment administered by the United States boundaries (for example, Wisconsin), for rural localities and recommended Census Bureau, which is a leading metropolitan areas (for example, that CMS monitor how the GPCI source of national, robust, quality, Metropolitan St. Louis, MO), portions of calculation changes affect the publicly available data. We agree that a a metropolitan area (for example, sustainability of health services in rural commercial data source for office rent Manhattan), or rest-of-state areas that communities. One commenter requested that provided for adequate exclude metropolitan areas (for that CMS consider the ongoing data representation of urban and rural areas example, Rest of Missouri). This locality issues regarding the GPCIs raised by nationally would be preferable to a configuration is used to calculate the stakeholders in the Midwest, and residential rent proxy. We have GPCIs that are in turn used to calculate establish 1.0 work and PE GPCI values previously discussed in the CY 2005, payments for physicians’ services under for Wisconsin and Iowa. CY 2008, and CY 2011 (69 FR 66262, 72 the PFS. Response: As discussed previously in FR 66376, and 75 FR 73257, As stated in the CY 2011 PFS final this section, we are required to update respectively) final rules that we rule with comment period (75 FR the GPCIs at least every 3 years to reflect recognize that apartment rents may not 73261), changes to the PFS locality the relative cost differences of operating be a perfect proxy for physician office structure would generally result in a medical practice in each locality rent. We have also conducted changes that are budget neutral within compared to the national average costs. exhaustive searches for reliable a state. For many years, before making Additionally, as previously discussed in commercial rent data sources that are any locality changes, we have sought this section, sections 1848(e)(1)(G) and publicly available in the past and have consensus from among the professionals 1848(e)(1)(I) of the Act established the not found any reliable data that meets whose payments would be affected. In permanent 1.5 work GPCI floor for our accuracy needs, and we continue to recent years, we have also considered Alaska and the permanent 1.0 PE GPCI conduct such searches. With regards to more comprehensive changes to locality floor for frontier States. We do not suggestion that CMS should collect configuration. In 2008, we issued a draft otherwise have the authority to establish commercial rent data, we note that we comprehensive report detailing four similar GPCI floors or other policies that discussed this issue in the CY 2012 PFS different locality configuration options do not take into consideration the final rule with comment period (76 FR (https://www.cms.gov/Medicare/ differences in physicians’ resource costs 73088) and stated with reference to Medicare-Fee-for-Service-Payment/ among localities. surveying physicians directly to gather PhysicianFeeSched/downloads/ Comment: One commenter supported data to compute office rent, we note that ReviewOfAltGPCIs.pdf). We refer the continuation of the 1.0 PE GPCI the development and implementation of readers to the CY 2014 PFS final rule floor for frontier states. a survey could take several years. with comment period for further Response: As previously discussed, Additionally, we have historically not discussion regarding that report, as well beginning January 1, 2011 section sought direct survey data from as a discussion about the Institute of 1848(e)(1)(I) of the Act set a permanent physicians related to the GPCI to avoid Medicine’s empirical study of the 1.0 PE GPCI floor for services furnished issues of circularity and self-reporting Medicare GAFs established under in frontier states (as defined in section bias. In the CY 2011 PFS final rule with sections 1848(e) (PFS GPCI) and 1848(e)(1)(I) of the Act). comment period (75 FR 73259), we

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solicited public comments regarding the based MEI cost share weights finalized implement, and could be prohibitively benefits of utilizing physician cost for use in the CY 2014 (seventh) GPCI expensive (75 FR 73259). We solicited reports to potentially achieve greater update, were proposed for the CY 2017 public comment regarding the potential precision in measuring the relative cost (eighth) GPCI update. The AMA is no benefits to be gained from establishing difference among Medicare localities. longer conducting the AMA PPIS a physician cost report and whether this We also asked for comments regarding survey, and CMS’ Office of the Actuary approach is appropriate to achieve the administrative burden of requiring continues to look into viable options for potentially greater precision in physicians to routinely complete these updating the MEI cost share weights measuring the relative cost differences cost reports and whether this should be going forward. In the CY 2014 PFS final in physicians’ practices among PFS mandatory for physicians’ practices. We rule with comment period (78 FR localities. We also solicited public did not receive any feedback related to 74275), we stated that we continue to comments on the potential that comment solicitation during the investigate possible data sources to use administrative burden of requiring open public comment period for the CY for the purpose of rebasing the MEI in physicians to routinely complete and 2011 final rule with comment period. the future. submit a cost report. We did not receive Comment: A few commenters We continue to have concerns that any feedback specifically related to that expressed concern with the use of physician cost reports could be comment solicitation (76 FR 73088). As prohibitively expensive, and as well unrelated proxy data for physician noted previously in this section, about the administrative burden this wages in geographic adjustment. The physicians’ wages are not included in approach would place on physician’s commenters expressed concern about the occupation categories (reference office staff. We reiterate that the GPCIs GPCI proxy inputs that result in are not an absolute measure of practice downward payment adjustments, which occupations) used in calculating the costs, rather they are a measure of the they believe do not reflect the actual work GPCI because Medicare payments relative cost differences for each of the cost of physician practices. The are a key determinant of physicians’ three GPCI components. The U.S. commenters stated that better data exist earnings. We have long maintained that Census Bureau is a federal agency that for measuring the real physician including physician wage data in specializes in data collection, accuracy, compensation rates, such as recruitment calculating the work GPCIs would and reliability, and we continue to compensation surveys and wages for potentially introduce some circularity to believe that where such a publicly physicians employed at federally the adjustment since Medicare available resource exists that can qualified health centers. The payments typically contribute to provide useful data to assess geographic commenters also stated that MedPAC physician wages. In other words, cost differences in office rent, even studies have confirmed that the data including physicians’ wages in the though it is a proxy for the exact data sources currently relied upon for physician work GPCI would, in effect, we seek, that we should utilize that geographic adjustment bear no make the indices, to some extent, available resource. Therefore, given its correlation to physician earnings. One dependent upon Medicare payments, national representation, reliability, high commenter also stated that CMS has which in turn are impacted by the response rate and frequent updates, we acknowledged that the proxies utilized indices. We reiterate that the work GPCI continue to believe the ACS residential for the purposes of geographic is not an absolute measure of physician rent data is the most appropriate data adjustment have never been validated earnings; rather it is a measure of the source available at this time for the and there never has been a new data relative wage differences for each purposes of calculating the rent index of source utilized in the twenty years since locality as compared to the national the PE GPCI. the fee schedule was implemented. The average; additionally, the work GPCI Comment: One commenter stated that commenters urged CMS to undertake reflects only one quarter of those it objects to the 8 percent weight that the necessary studies to identify relative wage differences consistent the rent expense category has been reference occupations that will with the statutory requirement as given by CMS in calculating the PE accurately reflect the higher input costs discussed previously in this section. GPCI, and stated that office rent should of rural physician earnings, and Comment: We received a few be given a much larger weight to more implement the resulting corrections to comments on the PFS locality structure accurately reflect its impact on the geographic adjustment of the fee that were not within the scope of the CY physician practice expenses, and CMS schedule as soon as possible. should commit resources to update this Response: We appreciate the 2017 proposed rule. For example, data since it is based on 10-year old data comments regarding the professional several commenters requested that from the 2006 AMA Physician Practice occupations used to determine the Prince William and Loudoun counties Information Survey (AMA PPIS). relative cost differences in physician in Virginia be changed from the Rest of Response: We would like to clarify earnings for purposes of calculating the Virginia locality into the DC + MD/VA that the office rent expense category has work GPCI. In consideration of the Suburbs locality. Another commenter a cost share weight of 10.223 percent, ongoing concerns regarding the stated that it believes large cuts to rural not 8 percent as indicated by the reference occupations and other proxy and rest-of-State areas should be commenter. The MEI cost share weights data used to calculate the GPCIs, we avoided or minimized, but locality were derived from data collected by the also note that in the past we received boundaries with large payment AMA on the AMA PPIS. CMS has comments suggesting the use of survey differences should not be in the middle previously stated that we believe the data to determine GPCI values, and of urban areas, because they create AMA PPIS is a reliable data source, stated that we would continue to payment cliffs where payment can however the AMA PPIS is not an consider the possibility of establishing a change by up to eight percent if an ongoing data source that is regularly physician cost report and requiring a office location is moved across a street published. We continued to use the sufficiently large sample of physicians or down a block. The commenter stated AMA PPIS data source in the CY 2014 in each locality to report data on actual that CMS should act quickly to create revisions to the MEI which have not costs incurred. However we also stated locality definitions that are not been further updated since, and that we believed that a physician cost constrained by county boundaries, and therefore, as discussed above, the 2006- report could take years to develop and advocated implementing locality

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definition changes based on requires that the fee schedule areas used to those counties that are in transition Metropolitan Statistical Areas. for payment in California must be areas that are now in MSAs, which are Response: We appreciate the Metropolitan Statistical Areas (MSAs) as only some of the counties in the 2013 suggestions for revisions to the PFS defined by the Office of Management California rest-of state locality and locality structure. As discussed above, and Budget (OMB) as of December 31 of locality 3. we did not propose changes to the PFS the previous year; and section Additionally, section 1848(e)(6)(C) of locality structure; we note that the 1848(e)(6)(A)(ii) of the Act requires that the Act establishes a hold harmless for update to the California Fee Schedule all areas not located in an MSA must be transition areas beginning with CY 2017 Areas discussed later in this section is treated as a single rest-of-state fee whereby the applicable GPCI values for the result of a statutory requirement. schedule area. The resulting a year under the new MSA-based Additionally, we would like to note modifications to California’s locality locality structure may not be less than that, absent statutory provisions like structure would increase its number of what they would have been for the year those that pertain to California, changes localities from 9 under the current under the current locality structure. to the locality configuration within a locality structure to 27 under the MSA- There are a total of 58 counties in state would lead to significant based locality structure. California, 50 of which are in transition redistributions in payments within that However, section 1848(e)(6)(D) of the areas as defined in section 1848(e)(6)(D) state. It has been our practice, and we Act defines transition areas as the fee of the Act. Therefore, 50 counties in have stated in previous rulemaking (72 schedule areas for 2013 that were the California are subject to the hold FR 38139, and 73 FR 38513), that we rest-of-state locality, and locality 3, harmless provision. The other 8 have not considered making changes to which was comprised of Marin County, counties, which are metropolitan localities without the support of a State Napa County, and Solano County. counties that are not defined as medical association(s) to demonstrate Section 1848(e)(6)(B) of the Act transition areas, are not held harmless consensus for the change among the specifies that the GPCI values used for for the impact of the new MSA-based professionals whose payments would be payment in a transition area are to be locality structure, and may therefore affected (with some increasing and some phased in over 6 years, from 2017 potentially experience slight decreases decreasing). Also, we would like to through 2021, using a weighted sum of in their GPCI values as a result of the clarify that, just as the localities under the GPCIs calculated under the new provisions in section 1848(e)(6) of the the Fee Schedule areas used in the PFS MSA-based locality structure and the Act, insofar as the locality in which they are comprised of one or more GPCIs calculated under the current PFS are located now newly includes data constituent counties, so are locality structure. That is, the GPCI from adjacent counties that decreases Metropolitan Statistical Areas. values applicable for these areas during their GPCI values relative to those that Therefore the concept of a payment cliff this transition period are a blend of would have applied had the new data between neighboring counties as what the GPCI values would have been not been incorporated. Therefore, the described by the commenter would not under the current locality structure, and GPCIs for these eight counties under the necessarily be mitigated by a change what the GPCI values would be under MSA-based locality structure may be from PFS fee schedule areas to the MSA-based locality structure. For less than they would have been under Metropolitan Statistical Areas. example, in the first year, CY 2017, the the current GPCI structure. The eight After consideration of the public applicable GPCI values for counties that counties that are not within transition comments received regarding the were previously in rest-of-state or areas are: Orange; Los Angeles; proposed CY 2017 GPCI data update, we locality 3 and are now in MSAs are a Alameda; Contra Costa; San Francisco; are finalizing as proposed. blend of 1/6 of the GPCI value San Mateo; Santa Clara; and Ventura b. California Locality Update to the Fee calculated for the year under the MSA- counties. Schedule Areas Used for Payment based locality structure, and 5/6 of the We emphasize that while transition Under Section 220(h) of the Protecting GPCI value calculated for the year under areas are held harmless from the impact Access to Medicare Act the current locality structure. The of the GPCI changes using the new proportions shift by 1/6 in each MSA-based locality structure, because (1) General Discussion and Legislative subsequent year so that, by CY 2021, the we proposed other updates for CY 2017 Change applicable GPCI values for counties as part of the eighth GPCI update, Section 220(h) of the PAMA added a within transition areas are a blend of including the use of updated data, new section 1848(e)(6) to the Act, that 5/6 of the GPCI value for the year under transition areas would still be subject to modifies the fee schedule areas used for the MSA-based locality structure, and 1/ impacts resulting from those other payment purposes in California 6 of the GPCI value for the year under updates. Table 13 illustrates using beginning in CY 2017. the current locality structure. Beginning GAFs, for CY 2017, the isolated impact Currently, the fee schedule areas used in CY 2022, the applicable GPCI values of the MSA-based locality changes and for payment in California are based on for counties in transition areas are the hold-harmless for transition areas the revised locality structure that was values calculated under the new MSA- required by section 1848(e)(6) of the implemented in 1997 as previously based locality structure. For the sake of Act, the impact of the use of updated discussed. Beginning in CY 2017, clarity, we reiterate that this data for GPCIs, and the combined section 1848(e)(6)(A)(i) of the Act incremental phase-in is only applicable impact of both of these changes.

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TABLE 13—IMPACT ON CALIFORNIA GAFSASARESULT OF SECTION 1848(e)(6) OF THE ACT AND UPDATED DATA BY FEE SCHEDULE AREA [Sorted alphabetically by locality name]

Combined impact of Transition 2016 2017 GAF % change 2017 GAF % change PAMA and Medicare fee schedule area area GAF w/o due to new w/ due to new GPCI 1848(e)(6) GPCI data 1848(e)(6) 1848(e)(6) data (%)

Bakersfield ...... 1 1.036 1.031 ¥0.48 1.031 0.00 ¥0.48 Chico ...... 1 1.036 1.031 ¥0.48 1.031 0.00 ¥0.48 El Centro ...... 1 1.036 1.031 ¥0.48 1.031 0.00 ¥0.48 Fresno ...... 1 1.036 1.031 ¥0.48 1.031 0.00 ¥0.48 Hanford-Corcoran ...... 1 1.036 1.031 ¥0.48 1.031 0.00 ¥0.48 Los Angeles-Long Beach-Anaheim (Los Angeles Cnty) 0 1.092 1.090 ¥0.18 1.091 0.09 ¥0.09 Los Angeles-Long Beach-Anaheim (Orange Cnty) ...... 0 1.111 1.104 ¥0.63 1.101 ¥0.27 ¥0.90 Madera ...... 1 1.036 1.031 ¥0.48 1.031 0.00 ¥0.48 Merced ...... 1 1.036 1.031 ¥0.48 1.031 0.00 ¥0.48 Modesto ...... 1 1.036 1.031 ¥0.48 1.031 0.00 ¥0.48 Napa ...... 1 1.137 1.128 ¥0.79 1.128 0.00 ¥0.79 Oxnard-Thousand Oaks-Ventura ...... 0 1.089 1.083 ¥0.55 1.083 0.00 ¥0.55 Redding ...... 1 1.036 1.031 ¥0.48 1.031 0.00 ¥0.48 Rest of California ...... 1 1.036 1.031 ¥0.48 1.031 0.00 ¥0.48 Riverside-San Bernardino-Ontario ...... 1 1.036 1.031 ¥0.48 1.032 0.10 ¥0.39 Sacramento-Roseville-Arden-Arcade ...... 1 1.036 1.031 ¥0.48 1.031 0.00 ¥0.48 Salinas ...... 1 1.036 1.031 ¥0.48 1.033 0.19 ¥0.29 San Diego-Carlsbad ...... 1 1.036 1.031 ¥0.48 1.035 0.39 ¥0.10 San Francisco-Oakland-Hayward (Alameda/Contra Costa Cnty) 0 1.124 1.125 0.09 1.142 1.51 1.60 San Francisco-Oakland-Hayward (Marin Cnty) ...... 1 1.137 1.128 ¥0.79 1.129 0.09 ¥0.70 San Francisco-Oakland-Hayward (San Francisco Cnty) 0 1.191 1.194 0.25 1.175 ¥1.59 ¥1.34 San Francisco-Oakland-Hayward (San Mateo Cnty) .... 0 1.182 1.187 0.42 1.171 ¥1.35 ¥0.93 San Jose-Sunnyvale-Santa Clara (San Benito Cnty) .... 1 1.036 1.031 ¥0.48 1.053 2.13 1.64 San Jose-Sunnyvale-Santa Clara (Santa Clara Cnty) .. 0 1.175 1.176 0.09 1.175 ¥0.09 0.00 San Luis Obispo-Paso Robles-Arroyo Grande ...... 1 1.036 1.031 ¥0.48 1.031 0.00 ¥0.48 Santa Cruz-Watsonville ...... 1 1.036 1.031 ¥0.48 1.042 1.07 0.58 Santa Maria-Santa Barbara ...... 1 1.036 1.031 ¥0.48 1.036 0.48 0.00 Santa Rosa ...... 1 1.036 1.031 ¥0.48 1.037 0.58 0.10 Stockton-Lodi ...... 1 1.036 1.031 ¥0.48 1.031 0.00 ¥0.48 Vallejo-Fairfield ...... 1 1.137 1.128 ¥0.79 1.128 0.00 ¥0.79 Visalia-Porterville ...... 1 1.036 1.031 ¥0.48 1.031 0.00 ¥0.48 Yuba City ...... 1 1.036 1.031 ¥0.48 1.031 0.00 ¥0.48 Note: the Los Angeles-Long Beach-Anaheim; San Francisco-Oakland-Hayward; and San Jose-Sunnyvale-Santa Clara Medicare localities are represented at a sub-locality level for the purpose of demonstrating the variation of the GAF within the locality. The variation in the Los-Angeles- Long Beach-Anaheim locality exists only in CY 2017 and results from the two-year 50/50 phase in of the GPCI. The GAF variation in San Fran- cisco-Oakland-Hayward and San Jose-Sunnyvale-Santa Clara results from the localities containing both transition area and non-transition area counties. For the remainder of Medicare localities, the GAF is consistent throughout the entire locality.

Additionally, for the purposes of with the implementation of the GPCI gradually, in increments of one-sixth calculating budget neutrality and floor provisions that have previously over 6 years. Section 1848(e)(1)(C) of the consistent with the PFS budget been implemented—that is, as an after- Act requires that, if more than 1 year neutrality requirements as specified the-fact adjustment that is implemented has elapsed since the date of the last under section 1848(c)(2)(B)(ii)(II) of the for purposes of payment after both the previous GPCI adjustment, the Act, we proposed to start by calculating GPCIs and PFS budget neutrality have adjustment to be applied in the first year the national GPCIs as if the current already been calculated. of the next adjustment shall be 1/2 of localities are still applicable (2) Operational Considerations the adjustment that otherwise would be nationwide; then for the purposes of made. While section 1848(e)(6)(B) of the As discussed above, under section payment in California, we override the Act establishes a blended phase-in for 1848(e)(6) of the Act, counties that were GPCI values with the values that are the MSA-based GPCI values, it does not previously in the rest-of-state locality or applicable for California consistent with locality 3 and are now in MSAs would explicitly state whether or how that the requirements of section 1848(e)(6) of have their GPCI values under the new provision is to be reconciled with the the Act. This approach is consistent MSA-based locality structure phased in requirement at section 1848(e)(1)(C) of

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the Act. We believe that since section locality structure to 27 under the MSA- existing fee schedule areas. Pursuant to 1848(e)(6)(A) of the Act requires that we based locality structure. However, both the implementation of the new MSA- must make the change to MSA-based fee the current localities and the MSA- based locality structure for California, schedule areas for California GPCIs based localities are comprised of various the total number of PFS localities would notwithstanding the preceding component counties, and in some increase from 89 to 112. Table 14 provisions of section 1848(e) of the Act, localities only some of the component displays the current fee schedule areas and subject to the succeeding provisions counties are subject to the blended in California, and Table 15 displays the of section 1848(e)(6) of the Act, that phase-in and hold harmless provisions MSA-based fee schedule areas in applying the two-year phase-in required by section 1848(e)(6)(B) and (C) California required by section 1848(e)(6) specified by the preceding provisions of the Act. Therefore, the application of of the Act. Additional information on simultaneously with the six-year phase- these provisions may produce differing the California locality update may be in would undermine the incremental 6- GPCI values among counties within the found in our contractor’s draft report, year phase-in specified in section same fee schedule area under the MSA- ‘‘Draft Report on the CY 2017 Update of 1848(e)(6)(B) of the Act. Therefore, we based locality structure. For example, the Geographic Practice Cost Index for proposed that the requirement at section the MSA-based San Jose-Sunnyvale- the Medicare Physician Fee Schedule,’’ 1848(e)(1)(C) of the Act to phase in 1/ Santa Clara locality, is comprised of 2 which is available on the CMS Web site. 2 of the adjustment in year 1 of the GPCI constituent counties—San Benito It is located under the supporting update would not apply to counties that County, and Santa Clara County. San documents section of the CY 2017 PFS were previously in the rest-of-state or Benito County is in a transition area final rule located at https:// locality 3 and are now in MSAs, and (2013 rest-of-state), while Santa Clara www.cms.gov/Medicare/Medicare-Fee- therefore, are subject to the blended County is not. Hence, although the for-Service-Payment/ phase-in as described above. Since counties are in the same MSA, the PhysicianFeeSched/index.html. section 1848(e)(6)(B) of the Act provides requirements of section 1848(e)(6)(B) for a gradual phase in of the GPCI values and (C) of the Act may produce differing TABLE 14—CURRENT FEE SCHEDULE under the new MSA-based locality GPCI values for each county. To address AREAS IN CALIFORNIA structure, specifically in one-sixth this issue, we proposed to assign a increments over 6 years, if we were to unique locality number to the counties [Sorted alphabetically by locality name] also apply the requirement to phase in that would be impacted in the Locality Fee schedule 1/2 of the adjustment in year 1 of the aforementioned manner. As a result, number area Counties GPCI update then the first year although the modifications to increment would effectively be one- California’s locality structure increase 26 ...... Anaheim/Santa Orange. twelfth. We note that this issue is only the number of localities from 9 under Ana. of concern if more than 1 year has the current locality structure to 27 18 ...... Los Angeles ..... Los Angeles. elapsed since the previous GPCI update, under the MSA-based locality structure, 03 ...... Marin/Napa/So- Marin, Napa, and would only be applicable through for purposes of payment, the actual lano. And Solano. CY 2021 since, beginning in CY 2022, number of localities under the MSA- 07 ...... Oakland/Berkley Alameda and the GPCI values for such areas in an based locality structure would be 32 to Contra Costa. MSA would be fully based on the values account for instances where unique 05 ...... San Francisco .. San Francisco. calculated under the new MSA-based locality numbers are needed as 06 ...... San Mateo ...... San Mateo. locality structure for California. described above. Additionally, while 09 ...... Santa Clara ...... Santa Clara. As previously stated, the resulting the fee schedule area names are 17 ...... Ventura ...... Ventura. modifications to California’s locality consistent with the MSAs designated by 99 ...... Rest of State .... All Other Coun- structure increase its number of OMB, we proposed to maintain 2-digit ties. localities from 9 under the current locality numbers to correspond to the

TABLE 15—MSA-BASED FEE SCHEDULE AREAS IN CALIFORNIA [Sorted alphabetically by locality name]

Current New locality locality Fee schedule area Counties Transition number number (MSA name) area

99 ...... 54 Bakersfield, CA...... Kern ...... YES. 99 ...... 55 Chico, CA...... Butte ...... YES. 99 ...... 71 El Centro, CA ...... Imperial ...... YES. 99 ...... 56 Fresno, CA...... Fresno ...... YES. 99 ...... 57 Hanford-Corcoran, CA...... Kings ...... YES. 18 ...... 18 Los Angeles-Long Beach-Anaheim, CA (Los Angeles County) Los Angeles ...... NO. 26 ...... 26 Los Angeles-Long Beach-Anaheim, CA (Orange County) ...... Orange ...... NO. 99 ...... 58 Madera, CA...... Madera ...... YES. 99 ...... 59 Merced, CA...... Merced ...... YES. 99 ...... 60 Modesto, CA...... Stanislaus ...... YES. 3 ...... 51 Napa, CA...... Napa ...... YES. 17 ...... 17 Oxnard-Thousand Oaks-Ventura, CA ...... Ventura ...... NO. 99 ...... 61 Redding, CA...... Shasta ...... YES. 99 ...... 75 Rest of State ...... All Other Counties ...... YES. 99 ...... 62 Riverside-San Bernardino-Ontario, CA ...... Riverside, And San Bernardino ...... YES. 99 ...... 63 Sacramento—Roseville—Arden-Arcade, CA...... El Dorado, Placer, Sacramento, And YES. Yolo. 99 ...... 64 Salinas, CA...... Monterey ...... YES. 99 ...... 72 San Diego-Carlsbad, CA ...... San Diego ...... YES.

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TABLE 15—MSA-BASED FEE SCHEDULE AREAS IN CALIFORNIA—Continued [Sorted alphabetically by locality name]

Current New locality locality Fee schedule area Counties Transition number number (MSA name) area

7 ...... 7 San Francisco-Oakland-Hayward, CA (Alameda County/ Alameda, Contra Costa ...... NO. Contra Costa County). 3 ...... 52 San Francisco-Oakland-Hayward, CA (Marin County) ...... Marin ...... YES. 5 ...... 5 San Francisco-Oakland-Hayward, CA (San Francisco County) San Francisco ...... NO. 6 ...... 6 San Francisco-Oakland-Hayward, CA (San Mateo County) ..... San Mateo ...... NO. 99 ...... 65 San Jose-Sunnyvale-Santa Clara, CA (San Benito County) ..... San Benito ...... YES. 9 ...... 9 San Jose-Sunnyvale-Santa Clara, CA (Santa Clara County) ... Santa Clara ...... NO. 99 ...... 73 San Luis Obispo-Paso Robles-Arroyo Grande, CA ...... San Luis Obispo ...... YES. 99 ...... 66 Santa Cruz-Watsonville, CA ...... Santa Cruz ...... YES. 99 ...... 74 Santa Maria-Santa Barbara, CA ...... Santa Barbara ...... YES. 99 ...... 67 Santa Rosa, CA ...... Sonoma ...... YES. 99 ...... 73 Stockton-Lodi, CA ...... San Joaquin ...... YES. 3 ...... 53 Vallejo-Fairfield, CA...... Solano ...... YES. 99 ...... 69 Visalia-Porterville, CA...... Tulare ...... YES. 99 ...... 70 Yuba City, CA ...... Sutter, and Yuba ...... YES.

We received few comments regarding Francisco County) were incorrect in locality update, we do not believe there the California locality update to the fee Table 13 of the proposed rule, and have should be related burden on schedule areas used for payment under been corrected in Table 13 in this final practitioners, and California section 220(h) of PAMA. rule. We have also updated all of the practitioners will continue to follow the Comment: One commenter stated that 2016 GAFs in Table 13 to reflect 3 existing process for submitting claims. it supports the proposed California decimal places as to avoid confusion After consideration of the public payment locality implementation plan. with rounding as requested. comments received regarding the The commenter stated that based on its Additionally, we note that while the proposed California payment locality analysis the calculations are accurate GAFs for these 3 fee schedule areas implementation plan, we are finalizing except for a few errors. Specifically, the were incorrect in Table 13 of the as proposed. commenter stated that the CY 2016 proposed rule, the GAF values were GAFs for 3 fee schedule areas [Los 4. Update to the Methodology for correct in Addendum D to the proposed Calculating GPCIs in the U.S. Territories Angeles-Long Beach-Anaheim (Orange rule available on our Web site under the County), San Francisco-Oakland- supporting documents section of the CY In calculating GPCIs within U.S. Hayward (Alameda/Contra Costa 2017 PFS Proposed Rule Web page at states, we use county-level wage data County), and San Francisco-Oakland- https://www.cms.gov/Medicare/ from the Bureau of Labor Statistics Hayward (San Francisco County)] in Medicare-Fee-for-Service-Payment/ (BLS) Occupational Employment Table 13 of the proposed rule (81 FR PhysicianFeeSched/index.html. Statistics Survey (OES), county-level 46221 through 46222) were incorrect. Moreover, GAF values are an analysis residential rent data from the American The commenter also requested that all tool, and are not used to determine Community Survey (ACS), and of the 2016 GAFs in the table be service level payment. Additionally, we malpractice insurance premium data reported to three decimal places to note Sierra County was omitted from the from state departments of insurance. In avoid confusion with rounding. CY 2017 Proposed GPCI County Data calculating GPCIs for the U.S. territories, Additionally, the commenter indicated File because we removed counties with we currently use three distinct that Sierra County in California was 0 total RVUs in 2014. However, for the methodologies—one for Puerto Rico, missing from the CY 2017 Proposed final rule we have revised the file to another for the Virgin Islands, and a GPCI County Data File in the CY 2017 include all counties, even those with 0 third for the Pacific Islands (Guam, Proposed Rule GPCI Public Use Files total RVUs in 2014. The updated file American Samoa, and Northern available on our Web site under the can be viewed in the CY 2017 Final Marianas Islands). These three supporting documents section of the CY GPCI County Data File in the CY 2017 methodologies were adopted at different 2017 PFS proposed rule Web page at Final Rule GPCI Public use files times based primarily on the data that https://www.cms.gov/Medicare/ available on our Web site. were available at the time they were Medicare-Fee-for-Service-Payment/ Comment: One commenter requested adopted. At present, because Puerto PhysicianFeeSched/index.html. that CMS implement the California Rico is the only territory where county- Response: We thank the commenter locality update requirement in a manner level BLS OES, county-level ACS, and for its support of our proposed that does not require the Medicare malpractice premium data are available, California payment locality Administrative Contractor (MAC) for it is the only territory for which we use implementation plan. With regard to the California to make changes to the territory-specific data to calculate errors noted by the commenter, we enrollment process for physician groups GPCIs. For the Virgin Islands, because thank the commenter for bringing this in California or changes in the way that county-level wage and rent data are not issue to our attention. We agree that the physician groups submit claims to the available, and insufficient malpractice CY 2016 GAFs for Los Angeles-Long MAC. premium data are available, CMS has set Beach-Anaheim (Orange County), San Response: While we note that there the work, PE, and MP GPCI values for Francisco-Oakland-Hayward (Alameda/ are several internal administrative the Virgin Islands payment locality at Contra Costa County), and San burdens that result from the the national average of 1.0 even though, Francisco-Oakland-Hayward (San implementation of the California like Puerto Rico, the Virgin Islands is its

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own locality and county-level BLS OES Update to the Methodology for would be an accurate reflection of costs data are available for the Virgin Islands. Calculating GPCIs in the U.S. Territories in those territories relative to national For the U.S. territories in the Pacific may be found in our contractor’s draft average costs. Ocean, we currently crosswalk GPCIs report, ‘‘Draft Report on the CY 2017 Comment: We received several from the Hawaii locality for each of the Update of the Geographic Practice Cost comments that are outside of the scope three GPCIs, and incorporate no local Index for the Medicare Physician Fee of the Physician Fee Schedule, data from these territories into the GPCI Schedule,’’ which is available on our requesting that CMS explore every calculations even though county-level Web site. It is located under the option to determine whether a one-time BLS OES data does exist for Guam, but supporting documents section of the CY correction can be made to the Medicare not for American Samoa or the Northern 2017 PFS final rule located at https:// Advantage (MA) regulatory cycle so that Mariana Islands. www.cms.gov/Medicare/Medicare-Fee- the per-person monthly payment to As noted above, currently Puerto Rico for-Service-Payment/ Puerto Rico MA Plans in CY 2017 will is the only territory for which we PhysicianFeeSched/index.html. reflect the increase to the fee-for-service calculate GPCIs using the territory- The following is a summary of the spending in the territory as a result of specific information relative to data comments we received regarding the the proposed GPCI increase. Some from the U.S. States. For several years proposed update to the methodology for commenters stated that it is imperative stakeholders in Puerto Rico have raised calculating GPCIs in the U.S. territories. that CMS see that the increased concerns regarding the applicability of Comment: Several commenters physician fees reach the actual the proxy data in Puerto Rico relative to expressed support for CMS’ proposal to providers and are not diverted away their applicability in the U.S. states. We assign the national average of 1.0 to from patient care by third parties such believe that these concerns may be each GPCI in Puerto Rico, stating that as Medicare Advantage Organizations. consistent across island territories, but the physicians in Puerto Rico who treat Some commenters requested that CMS lack of available, appropriate data has patients enrolled in fee-for-service clarify that the new GPCIs will be made it difficult to quantify such Medicare will be reimbursed in a incorporated into the MA benchmarks variation in costs. For example, some manner that more closely aligns with in CY 2018. stakeholders previously indicated that the manner in which physicians in the Response: We appreciate the concerns shipping and transportation expenses other U.S. territories are reimbursed, raised by the commenters. Consistent increase the cost of acquiring medical and better reflects the cost of practicing with the statute, we published the final equipment and supplies in islands and medicine in Puerto Rico. Other CY 2017 Rate Announcement for territories relative to the mainland. commenters supporting the proposal Medicare Advantage on April 4, 2016. While we have previously attempted to also suggested that there has been a Medicare Advantage actuarial bids and locate data sources specific to need for revision of Medicare payment benefit packages for 2017 have been geographic variation in such shipping in Puerto Rico, and that the territories approved by CMS and sponsors have costs, we found no comprehensive of the U.S. have not been treated begun marketing plan to beneficiaries. national data source for this information similarly even though the territories are Thus, a change in to CY 2017 (we refer readers to 78 FR 74387 much alike. Another commenter stated benchmark would be disruptive to through 74388 for the detailed that the existing fee schedule for Puerto beneficiaries. In future years, including discussion of this issue). Therefore, we Rico does not correlate with the cost of CY 2018, we will follow our normal have not been able to quantify variation caring for patients, and that the process for calculating rates. This in costs specific to island territories in proposed policy is long overdue. Some process incorporates historical Fee for the calculation of the GPCIs. commenters also stated that increasing Service expenditures, which would For all the island territories other than the GPCI’s for Puerto Rico is an include any updates to Fee for Service Puerto Rico, the lack of comprehensive important and necessary first step in payment rates, such as an adjustment to data about unique costs for island trying to salvage Puerto Rico’s the Puerto Rico GPCI. CMS will not be territories has had minimal impact on deteriorated health system. making any adjustments to CY 2017 GPCIs because we have used either the Response: We thank the commenters Medicare Advantage rates as a result of Hawaii GPCIs (for the Pacific territories) for their support. this final rule. Finally, we note that or used the unadjusted national Comment: A few commenters according to the statute, we are averages (for the Virgin Islands). In an requested that CMS consider raising the prohibited from interfering or directing effort to provide greater consistency in GPCI values in Puerto Rico to 1.25. the contracting between Medicare the calculation of GPCIs given the lack Response: We proposed assigning the Advantage Organizations (MAOs) and of comprehensive data regarding the national average of 1.0 to each GPCI contracted providers. As such, we are validity of applying the proxy data used index for both Puerto Rico and the not permitted to dictate to MAOs how in the States in accurately accounting Virgin Islands, in an effort to provide any increase in payment rates can be for variability of costs for these island greater consistency in the calculation of spent, including on provider rates. territories, we proposed to treat the GPCIs among these island territories, Comment: One commenter suggested Caribbean Island territories (the Virgin given the lack of information on the that if the MA benchmark cannot be Islands and Puerto Rico) in a consistent validity of applying the proxy data used adjusted for CY 2017 that CMS should manner. We proposed to do so by in the States to accurately account for postpone the applicability of the GPCI assigning the national average of 1.0 to variability of costs in these territories as change in Puerto Rico until CY 2018 each GPCI index for both Puerto Rico compared to the national average costs. when such an effect is also reflected in and the Virgin Islands. We did not Ultimately we proposed to treat the the MA benchmarks. propose any changes to the GPCI Caribbean Island territories (the Virgin Response: We do not agree that the methodology for the Pacific Island Islands and Puerto Rico) in a consistent proposal to update to the methodology territories (Guam, American Samoa, and manner by assigning the national for calculating GPCIs in the U.S. Northern Marianas Islands) where we average of 1.0 to each GPCI index. We territories, which will provide greater already consistently assign the Hawaii do not believe that it would be consistency in the calculation of GPCIs GPCI values for each of the three GPCIs. appropriate to raise the value to 1.25 in for these areas, should be delayed based Additional information on the Proposed the absence of data demonstrating that on when the MA benchmarks will

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reflect the increases as a result of this methodology, and we are finalizing as have the authority to alter the policy. proposed. application of the provision based on After consideration of the public these comments. J. Payment Incentive for the Transition Comment: An overwhelming majority comments received regarding our From Traditional X-Ray Imaging to proposal to treat the Caribbean Island of the commenters requested CMS Digital Radiography and Other Imaging implement an alternative policy to territories (the Virgin Islands and Puerto Services Rico) in a consistent manner, by improve quality of imaging services. assigning the national average of 1.0 to Section 502(a)(1) of Division O, Title The recommended policy would require each GPCI index for both Puerto Rico V of the Consolidated Appropriations registered radiologic technicians to and the Virgin Islands, we are finalizing Act, 2016 (Pub. L. 114–113) amended perform all Medicare film or digital as proposed. section 1848(b) of the Act by adding radiography procedures. Other new paragraph (b)(9). Effective for commenters countered this 5. Refinement to the MP GPCI services furnished on or after January 1, recommended alternative by stating that Methodology 2017, section 1848(b)(9)(A) of the Act it would exclude otherwise qualified In the process of calculating MP reduces by 20 percent the payment professionals who have undergone GPCIs for the purposes of this final rule, amounts under the PFS for the technical education to acquire limited scope we identified several technical component (TC) (including the TC licenses or certification programs refinements to the methodology that portion of a global services) of imaging demonstrating As Low As Reasonably services that are X-rays taken using film. yield improvements over the current Achievable (ALARA) safety practices by The reduction is made prior to any other method. We also proposed refinements either a third party, vendor training, or adjustment under this section and that conform to our proposed another didactic course deemed without application of this new methodology for calculating the GPCIs acceptable by any of the four paragraph. for the U.S. Territories described above. accreditation organizations. One Section 1848(b)(9) of the Act allows commenter also referenced 35 states that Specifically, we proposed modifications for the implementation of the payment to the methodology to account for have an entry level certification for X- reduction through appropriate ray technicians and that throughout the missing data used in the calculation of mechanisms which may include use of the MP GPCI. Under the methodology US, there are x-ray technicians and modifiers. In accordance with section limited scope X-ray machine operators used in the CY 2014 GPCI update (78 FR 1848(c)(2)(B)(v)(X), the adjustments that are also licensed and certified. 74380 through 74391), we first under section 1848(b)(9)(A) of the Act Response: We appreciate commenters’ calculated the average premiums by are exempt from budget neutrality. interests in standards that might insurer and specialty, then imputed To implement this provision, in the improve quality of care for Medicare premium values for specialties for CY 2017 PFS proposed rule (81 FR beneficiaries, but we did not propose a which we did not have specific data, 46224), we proposed to establish a new policy regarding standards for radiologic before adjusting the specialty-specific modifier to be used on claims that technicians in the proposed rule. Also, premium data by market share weights. include imaging services that are X-rays as previously stated, we do not believe We proposed to revise our methodology (including the imaging portion of a we have the authority to implement to instead calculate the average service) taken using film. Since the conditions of payment regarding premiums for each specialty using display of the proposed rule, modifier radiologic technicians as an alternative issuer market share for only available FX has been established for that to the adjustments required by the companies. This proposed purpose. Effective January 1, 2017, the statutory provision. methodological improvement would modifier must be used on claims for X- Comment: A commenter reduce potential bias resulting from rays that are taken using film. The use recommended that a financial incentive large amounts of imputation, an issue of this modifier will result in a 20 be provided for physicians to convert to that is prevalent for insurers that only percent reduction for the X-ray service, digital machines as had been done in write policies for ancillary specialties as specified under section 1848(b)(9)(A) the case of electronic medical records. for which premiums tend to be low. The of the Act. Response: The legislation does not current method would impute the low The proposed rule preamble stated authorize any financial incentive in the premiums for ancillary specialties that the applicable HCPCS codes form of increased payment, but provides across the remaining specialties, and describing imaging services that are X- an incentive to use digital images to generally greater imputation leads to ray services could be found on the PFS avoid the 20 percent reduction that less accuracy. Additional information Web site. However, we did not intend applies to imaging services that are X- on the MP GPCI methodology, and the this to indicate that we would be rays taken using film. proposed refinement to the MP GPCI developing or displaying an exhaustive Comment: One commenter requested methodology may be found in our list of applicable codes. Instead, we that in the absence of a meaningful contractor’s draft report, ‘‘Draft Report intended to refer to the several lists of opportunity to comment on the list of on the CY 2017 Update of the PFS imaging codes, including those that codes for which the policy applies, the Geographic Practice Cost Index for the describe imaging services that are X- provision should be limited to Medicare Physician Fee Schedule,’’ rays. traditional diagnostic X-ray procedures which is available on our Web site. It is Comment: Many commenters only. Two commenters presented located under the supporting documents commented on the merits of the separate lists of codes for which the section of the CY 2017 PFS final rule statutory provision. The commenters payment reduction should apply. One located at https://www.cms.gov/ stated that the reduction of Medicare commenter also provided codes that Medicare/Medicare-Fee-for-Service- film-based x-ray payments by 20 percent should be explicitly excluded from the Payment/PhysicianFeeSched/ will have unintended consequences on payment reduction, for example, index.html. patient care. radiographic-fluoroscopic, vascular and We did not receive any comments Response: We believe our proposal mammography X-ray imaging services, regarding the proposed technical would implement the required statutory radioscopic, radioscopic and refinements to the MP GPCI provision and we do not believe that we radiography services provided in a

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single examination. Other commenters the professional component (PC) of been a priority to revalue services also provided a list of procedures that advanced imaging services. The regularly to make sure that the payment should be excluded. The commenter reduction applies when multiple rates reflect the changing trends in the also requested that we publish the list imaging procedures are furnished by the practice of medicine and current prices of applicable codes as soon as possible. same physician (or physician in the for inputs used in the PE calculations. Response: As previously stated, we same group practice) to the same Initially, this was accomplished did not publish an exhaustive list of patient, in the same session, on the primarily through the 5-year review applicable codes, and previously same day. Full payment is made for the process, which resulted in revised work intended to point to existing lists of PFS PC of the highest priced procedure. RVUs for CY 1997, CY 2002, CY 2007, imaging services. We believe that Payment for the PC of subsequent and CY 2012, and revised PE RVUs in physicians and non-physician services is reduced by 25 percent. CY 2001, CY 2006, and CY 2011. Under practitioners are in the best position to Section 502(a)(2)(A) of Division O, the 5-year review process, revisions in determine whether a particular imaging Title V of the Consolidated RVUs were proposed and finalized via service is an X-ray taken using film. Appropriations Act, 2016 (Pub. L. 114– rulemaking. In addition to the 5-year Comment: One commenter suggested 113, enacted on December 18, 2015) reviews, beginning with CY 2009, CMS that if at least half of the number of added a new section 1848(b)(10) of the discrete X-ray exposures required for and the RUC have identified a number Act which revises the payment of potentially misvalued codes each the radiographic exam are captured reduction from 25 percent to 5 percent, using a DR detector, then the year using various identification effective January 1, 2017. Section screens, as discussed in section II.D.4 of examination should be considered as 502(a)(2)(B) added a new subclause at digital and the payment differential this final rule. Historically, when we section 1848(c)(2)(B)(v)(XI) which received RUC recommendations, our should not be applied. Another exempts the reduced expenditures process had been to establish interim commenter requested that we clarify attributable to the revised 5 percent final RVUs for the potentially misvalued that the law only applies (and requires MMPR on the PC of imaging from the codes, new codes, and any other codes use of a modifier) to sites that use X-ray PFS budget neutrality provision. We for which there were coding changes in as a single method for image capture. proposed to implement these provisions the final rule for a year. Then, during The commenter also seeks clarification for services furnished on or after the 60-day period following the that if a site uses both X-ray film and January 1, 2017. We refer readers to publication of the final rule, we electronic capture of images and section VI.C of this final rule regarding accepted public comment about those maintains digital archives, by a picture the necessary adjustment to the valuations. For services furnished archiving communication system or proposed PFS conversion factor to other electronic method, that the site is account for the mandated exemption during the calendar year following the not required to report the modifier. from PFS budget neutrality. publication of interim final rates, we Response: At this time, in accordance We note that the lists of services for paid for services based upon the interim with the statute, we are requiring the FX the upcoming calendar year that are final values established in the final rule. modifier to be used whenever an subject to the MPPR on diagnostic In the final rule with comment period imaging service is an X-ray taken using cardiovascular services, diagnostic for the subsequent year, we considered film. As stated, the statute requires that imaging services, diagnostic and responded to public comments if an imaging service is an X-ray taken ophthalmology services, and therapy received on the interim final values, and using film, a reduction in payment is to services; and the list of procedures that typically made any appropriate occur. The statutory requirement meet the definition of imaging under adjustments and finalized those values. applies at the service level, not based on section 5102(b) of the Deficit Reduction In the CY 2015 PFS final rule with where the service is furnished or the Act (DRA), and therefore, are subject to comment period, we finalized a new method used to store images. There is the OPPS cap, are displayed in the process for establishing values for new, no provision for an exception to the public use files for the PFS proposed revised and potentially misvalued payment reduction based on the and final rules for each year. The public codes. Under the new process, we availability of various technologies or use files for CY 2017 are available on include proposed values for these the use of certain image archiving our Web site under downloads for the services in the proposed rule, rather technology at a particular site. CY 2017 PFS final rule with comment than establishing them as interim final After consideration of the public period at http://www.cms.gov/Medicare- in the final rule with comment period. comments we received, we are Fee-for-Service-Payment/ Beginning with the CY 2017 proposed finalizing the establishment of new PhysicianFeeSched/PFSFederal- rule, the new process is applicable to all modifier ‘‘FX’’ to be reported on claims Regulation-Notices.html. codes, except for new codes that for imaging services that are X-rays that Comment: Commenters supported the describe truly new services. For CY are taken using film. proposal to implement the statutory Beginning January 1, 2017, claims for 2017, we proposed new values in the provision. CY 2017 proposed rule for the vast imaging services that are X-rays taken Response: We our finalizing our CY using film must include the modifier majority of new, revised, and potentially 2017 proposal to revise the MPPR on the misvalued codes for which we received ‘‘FX.’’ PC of diagnostic imaging services. The use of this modifier will result in complete RUC recommendations by a 20 percent reduction for the X-ray L. Valuation of Specific Codes February 10, 2016. To complete the transition to this new process, for codes service, as specified under section 1. Background: Process for Valuing 1848(b)(9)(A) of the Act. where we established interim final New, Revised, and Potentially values in the CY 2016 PFS final rule K. Procedures Subject to the Multiple Misvalued Codes with comment period, we reviewed the Procedure Payment Reduction (MPPR) Establishing valuations for newly comments received during the 60-day and the OPPS Cap created and revised CPT codes is a public comment period following Effective January 1, 2012, we routine part of maintaining the PFS. release of the CY 2016 PFS final rule implemented an MPPR of 25 percent on Since inception of the PFS, it has also with comment period, and re-proposed

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values for those codes in the CY 2017 code based on component pieces of the at least one-third of the work time in proposed rule. code. both the preservice evaluation and We considered public comments Components used in the building postservice period is duplicative of received during the 60-day public block approach may include preservice, work furnished during the E/M visit. comment period for the proposed rule intraservice, or postservice time and Accordingly, in cases where we before establishing final values in this post-procedure visits. When referring to believe that the RUC has not adequately final rule. As part of our established a bundled CPT code, the building block accounted for the overlapping activities process we will adopt interim final components could be the CPT codes in the recommended work RVU and/or values only in the case of wholly new that make up the bundled code and the times, we adjust the work RVU and/or services for which there are no inputs associated with those codes. times to account for the overlap. The predecessor codes or values and for Magnitude estimation refers to a work RVU for a service is the product which we do not receive methodology for valuing work that of the time involved in furnishing the recommendations in time to propose determines the appropriate work RVU service multiplied by the intensity of values. For CY 2017, we are not aware for a service by gauging the total amount the work. Preservice evaluation time of any new codes that describe such of work for that service relative to the and postservice time both have a long- wholly new services. Therefore, we are work for a similar service across the PFS established intensity of work per unit of not establishing any code values on an without explicitly valuing the time (IWPUT) of 0.0224, which means interim final basis. However, we remind components of that work. In addition to that 1 minute of preservice evaluation or stakeholders that we continually review these methodologies, we have postservice time equates to 0.0224 of a stakeholder information regarding the frequently utilized an incremental work RVU. valuation of codes under the potentially methodology in which we value a code Therefore, in many cases when we misvalued code initiative and, under based upon its incremental difference remove 2 minutes of preservice time our existing process, could consider between another code or another family and 2 minutes of postservice time from proposing any particular changes as of codes. The statute specifically defines a procedure to account for the overlap early as CY 2018 rulemaking. the work component as the resources in with the same day E/M service, we also time and intensity required in remove a work RVU of 0.09 (4 minutes 2. Methodology for Proposing Work furnishing the service. Also, the × 0.0224 IWPUT) if we do not believe RVUs published literature on valuing work the overlap in time has already been We conduct a review of each code has recognized the key role of time in accounted for in the work RVU. The identified in this section and review the overall work. For particular codes, we RUC has recognized this valuation current work RVU (if any), RUC- refine the work RVUs in direct policy and, in many cases, now recommended work RVU, intensity, proportion to the changes in the best addresses the overlap in time and work time to furnish the preservice, information regarding the time when a service is typically furnished on intraservice, and postservice activities, resources involved in furnishing the same day as an E/M service. as well as other components of the particular services, either considering We note that many commenters and service that contribute to the value. Our the total time or the intraservice time. stakeholders have expressed concerns review of recommended work RVUs and Several years ago, to aid in the with our ongoing adjustment of work time inputs generally includes, but is development of preservice time RVUs based on changes in the best not limited to, a review of information recommendations for new and revised information we have regarding the time provided by the RUC, HCPAC (Health CPT codes, the RUC created resources involved in furnishing Care Professionals Advisory standardized preservice time packages. individual services. We are particularly Committee), and other public The packages include preservice concerned with the RUC’s and various commenters, medical literature, and evaluation time, preservice positioning specialty societies’ objections to our comparative databases, as well as a time, and preservice scrub, dress and approach given the significance of their comparison with other codes within the wait time. Currently there are six recommendations to our process for PFS, consultation with other physicians preservice time packages for services valuing services and since much of the and health care professionals within typically furnished in the facility information we have used to make the CMS and the federal government, as setting, reflecting the different adjustments is derived from their survey well as Medicare claims data. We also combinations of straightforward or process. As explained in the CY 2016 assess the methodology and data used to difficult procedure, straightforward or PFS final rule with comment period (80 develop the recommendations difficult patient, and without or with FR 70933), we recognize that adjusting submitted to us by the RUC and other sedation/anesthesia. Currently, there are work RVUs for changes in time is not public commenters and the rationale for three preservice time packages for always a straightforward process, so we the recommendations. In the CY 2011 services typically furnished in the apply various methodologies to identify PFS final rule with comment period (75 nonfacility setting, reflecting procedures several potential work values for FR 73328 through 73329), we discussed without and with sedation/anesthesia individual codes. However, we want to a variety of methodologies and care. reiterate that we are statutorily obligated approaches used to develop work RVUs, We have developed several standard to consider both time and intensity in including survey data, building blocks, building block methodologies to value establishing work RVUs for PFS crosswalks to key reference or similar services appropriately when they have services. codes, and magnitude estimation (see common billing patterns. In cases where We have observed that for many codes the CY 2011 PFS final rule with a service is typically furnished to a reviewed by the RUC, final comment period for more information). beneficiary on the same day as an E/M recommended work RVUs appear to be When referring to a survey, unless service, we believe that there is overlap incongruous with recommended otherwise noted, we mean the surveys between the two services in some of the assumptions regarding the resource conducted by specialty societies as part activities furnished during the costs in time. This is the case for a of the formal RUC process. The building preservice evaluation and postservice significant portion of codes for which block methodology is used to construct, time. Our longstanding adjustments we have recently established or or deconstruct, the work RVU for a CPT have reflected a broad assumption that proposed work RVUs that are based on

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refinements to the RUC-recommended actions in adjusting the recommended recommended RVU, then we believe we values. When we have adjusted work work RVUs as inappropriate. We have the obligation to account for that RVUs to account for significant changes received several specific comments change in establishing work RVUs since in time, we begin by looking at the regarding this issue in response to the the statute explicitly identifies time as change in the time in the context of the CY 2016 PFS final rule with comment one of the two elements of the work RUC-recommended work RVU. When period and those comments are RVUs. We recognize that it would not be the recommended work RVUs do not summarized below. appropriate to develop work RVUs appear to account for significant Comment: Several commenters, solely based on time given that intensity changes in time, we employ the including the RUC, stated that our is also an element of work, but in different approaches to identify methodology for adjusting work RVUs applying the time ratios we are using potential values that reconcile the appears to be contrary to the statute. derived intensity measures based on recommended work RVUs with the Response: We disagree with these current work RVUs for individual recommended time values. Many of comments. Since section 1848(c)(1)(A) procedures. Were we to disregard these methodologies, such as survey of the Act explicitly identifies time as intensity altogether, the work RVUs for data, building blocks, crosswalks to key one of the two types of resources that all services would be developed based reference or similar codes, and encompass the work component of the solely on time values and that is magnitude estimation have long been PFS payment, we do not believe that our definitively not the case. Furthermore, used in developing work RVUs under use of the aforementioned we reiterate that we use time ratios to the PFS. In addition to these, we methodologies to adjust the work RVU identify potential work RVUs, and then sometimes use the relationship between to account for the changes in time, use other methods (including estimates the old time values and the new time which is one of the resources involved, of work from CMS medical personnel values for particular services to identify is inconsistent with the statutory and crosswalks to key reference or alternative work RVUs based on changes requirements related to the maintenance similar codes) to validate these RVUs. in time components. of work RVUs, and we have regularly We also disagree with several In so doing, rather than ignoring the used these and other methodologies in commenters’ implications that a work RUC-recommended value, we are using developing values for PFS services. In RVU developed through such estimation the recommended values as a starting selecting which methodological methods is only resource-based through reference and then applying one of these approach will best determine the the RUC process. several methodologies to account for the appropriate value for a service, we Comment: Several commenters, reductions in time that we believe have consider the current and recommended including the RUC, stated that our not otherwise been reflected in the RUC- work and time values, as well as the inconsistent use of the time ratio recommended value. When we believe intensity of the service, all relative to methodology has rendered it ineffective that such changes in time have already other services. In our review of RUC for valuation purposes and that by been accounted for in the RUC recommended values, we have observed choosing the starting base work value recommendation, then we do not make that the RUC also uses a variety of and/or physician time at random, we are such adjustments. Likewise, we do not methodologies to develop work RVUs essentially reverse engineering the work arbitrarily apply time ratios to current for individual codes, and subsequently value we want under the guise of a work RVUs to calculate proposed work validates the results of these approaches standard algorithm. RVUs. We use the ratios to identify through magnitude estimation or Response: We do not choose a starting potential work RVUs and consider these crosswalk to established values for other base work value and/or physician time work RVUs as potential options relative codes. at random as suggested by the to the values developed through other Comment: Several commenters, commenters. We use the RUC options. including the RUC, stated that we could recommended values or the existing We clarify that we are not implying not take one element of the services that values as the base values; essentially, that the decrease in time as reflected in has changed such as intra-service time, we are taking one of those values and survey values must equate to a one-to- and apply an overall ratio for reduction applying adjustments to account for the one or linear decrease in newly valued to the work RVU based on changes to change in time that based on our work RVUs. Instead, we believe that, time, as that renders the value no longer analysis of the RUC recommendation, since the two components of work are resource-based in comparison to the we determine has not been properly time and intensity, absent an obvious or RUC-recommended values. accounted for to determine an explicitly stated rationale for why the Response: We disagree with the appropriate work RVU. In relative intensity of a given procedure commenters and continue to believe circumstances where adjustments to has increased, significant decreases in that the use of time ratios is one of time and the corresponding work RVU time should be reflected in decreases to several reasonable methods for are relatively congruent or persuasively work RVUs. If the RUC recommendation identifying potential work RVUs for explained, our tendency has been to use has appeared to disregard or dismiss the particular PFS services, particularly those values as recommended. Where changes in time, without a persuasive when the alternative values do not the RUC recommendations do not explanation of why such a change account for information that suggests account for changes in time, we have should not be accounted for in the the amount of time involved in made changes to RUC-recommended overall work of the service, then we furnishing the service has changed values to account for the changes in generally use one of the aforementioned significantly. We reiterate that, time. referenced methodologies to identify consistent with the statute, we are Comment: Commenters, including the potential work RVUs, including the required to value the work RVU based RUC, also stated that the use of time methodologies intended to account for on the relative resources involved in ratio methodologies distills the the changes in the resources involved in furnishing the service, which include valuation of the service into a basic furnishing the procedure. time and intensity. When our review of formula with the only variable being Several commenters, including the recommended values determines that either the new total physician time or RUC, in general have objected to our use changes in the resource of time have the new intra-service physician time, of these methodologies and deemed our been unaccounted for in a and that these methodologies are based

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on the incorrect assumption that the per analysis to identify general tendencies work RVUs in strict proportion to minute physician work intensity in the relationship between changes in changes in time. We understand that established is permanent regardless of time and changes in work RVUs for CY intensity is not entirely linear, and that when the service was last valued. Other 2014 and CY 2015. We looked at data related to time as obtained in the commenters have suggested that services for which there were no coding RUC survey instrument may improve previous assumed times are inaccurate. changes to simplify the analysis. The over time, and that the number of Response: We agree with commenters intent of this preliminary analysis was survey respondents may improve over that per minute intensity for a given to examine commenters’ beliefs that time. However, we also understand time service may change over time. If we CMS is only considering time when as a tangible resource cost in furnishing believed that the per-minute intensity making refinements to RUC PFS services, and a cost that by statute, for a given service were immutable, then recommended work values. For CY is one of the two kinds of resources to a reverse-building block approach to 2014, we found that in the aggregate, the be considered as part of the work RVU. revaluation based on new time data average difference between the RUC Therefore, in the proposed rule, we could be appropriate. However, we have recommended intraservice time and stated that we were interested in not applied such an approach existing intraservice time was ¥17 receiving comments on whether, within specifically because we agree that the percent, but the average difference the statutory confines, there are per-minute intensity of work is not between the RUC recommended work alternative suggestions as to how necessarily static over time or even RVU and existing work RVU was only changes in time should be accounted for necessarily during the course of a ¥4 percent. However, the average when it is evident that the survey data procedure. Instead, we utilize time difference between the CMS refined and/or the RUC recommendation ratios to identify potential values that work RVU and existing work RVU was regarding the overall work RVU does account for changes in time and ¥7 percent. For CY 2015, the average not reflect significant changes in the compare these values to other PFS difference between the RUC resource costs of time for codes services for estimates of overall work. recommended intraservice time and describing PFS services. We solicited When the values we develop reflect a existing intraservice time was ¥17 comment on potential alternatives, similar derived intensity, we agree that percent, but the average difference including the application of the reverse our values are the result of our between the RUC recommended work building block methodology, to making assessment that the relative intensity of RVU and existing work RVU was 1 the adjustments that would recognize a given service has remained similar. percent, and the average difference overall estimates of work in the context Regarding the validity of comparing between the CMS refined work RVU and of changes in the resource of time for new times to the old times, we, too, existing work RVU was ¥6 percent. particular services. The following is a summary of the hope that time estimates have improved This preliminary analysis demonstrates over many years especially when many comments we received in response to that we are not making refinements years have elapsed since the last time our solicitation regarding potential solely in consideration of time, if that the service in question was valued. alternatives, including the application were the case, the changes in the work However, we also believe that our of the reverse building block RVU values that we adopted would be operating assumption regarding the methodology, to making the adjustments comparable to the changes in the time validity of the pre-existing values as a that would recognize overall estimates that we adopted, but that is not the case. point of comparison is critical to the of work in the context of changes in the integrity of the relative value system as We believe that we should account for resource of time for particular services. currently constructed. Pre-existing times efficiencies in time when the Comment: One commenter stated that are a very important element in the recommended work RVU does not it continues to support CMS in its allocation of indirect PE RVUs by account for those efficiencies, otherwise efforts to adjust work RVUs specialty, and had the previously relativity across the PFS can be commensurate with changes in intra- recommended times been significantly skewed over periods of service and total time, as well as post- overestimated, the specialties that time. For example, if when a code is operative visits despite RUC furnish such services would be first valued, a physician was previously recommendations to the contrary. The benefitting from these times in the able to do only 5 procedures per day, commenter agreed with our changes and allocation of indirect PE RVUs. As long but due to new technologies, the same encouraged CMS to continue to identify time observers of the RUC process, we physician can now do 10 procedures per and address such incongruities. The also recognize that the material the RUC day, resource costs in time have commenter stated that it is routine to uses to develop overall work empirically been lessened, and we encounter recommended decreases in recommendations includes the data believe that relative reduction in physician time and/or post-procedure from the surveys about time. We have resources involved in furnishing that visits combined with RUC previously stated concerns regarding the service should be accounted for in the recommendations to maintain or validity of much of the RUC survey assignment of work RVUs for that increase the work RVUs. The data. However, we believe additional service, since the statute explicitly commenter agreed that when physician kinds of concern would be warranted if identifies time as one of the two time decreases, physician work should the RUC itself were operating under the components of work. Of course, if more decrease comparatively, absent a assumption that its pre-existing data resource intensive technology has compelling argument that the intensity were typically inaccurate. allowed for the increased efficiency in of the service has increased sufficiently We understand stakeholders’ furnishing the procedure, then the to offset the decrease in physician time. concerns regarding how best to consider nonfacility PE RVUs for the service The commenter did not have alternative changes in time in improving the should also be adjusted to account for suggestions for how CMS should make accuracy of work RVUs and have this change. Additionally, we believe it these adjustments, and believes the considered all of the issues raised by may be that the intensity per minute of approaches that CMS has taken are commenters. In conjunction with our the procedure may have changed with reasonable and defensible. review of recommended code values for the greater efficiency in time. Again, Another commenter stated that it CY 2017, we conducted a preliminary that is why we do not generally reduce appreciates that CMS provided

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information about how it reviews words, the relative value of the other commenters also stated that the RUC recommendations for work RVUs that work RVUs has increased, across the recommendations now explicitly state come from the RUC. Additionally, one PFS, whenever we apply a positive when physician time has changed and commenter stated appreciation for the budget neutrality adjustment to the CF address whether and to what magnitude consideration and effort that CMS gives to account for an overall decrease in these changes in time impact the work in valuing the work RVUs for a service. work RVUs. involved. The commenter stated that the accuracy Comment: A few commenters, Response: We appreciate the of RVU estimates has improved as a including the RUC, stated that they commenters’ feedback. We understand result of CMS’ various validation appreciate CMS agreeing with the RUC’s that not all components of physician processes for collecting data and its assertion that the usage of time ratios to time have identical intensity and are consideration of feedback from the RUC reduce work RVUs is typically not mindful of this point when we are and public commenters. The commenter appropriate, as often a change in determining what the appropriate work stated that CMS should account for physician time coincides with a change RVU values should be. We also agree efficiencies in the resource costs of time in the physician work intensity per that the nuanced variables involved in when the recommended work RVU does minute. The commenters stated that the changing components of physician not account for emerging efficiencies, CMS acknowledges that physician work time must be accounted for, and it is our such as advances in surgical techniques, intensity per minute is typically not goal to do so when determining the and that by considering time in these linear and also that making reductions appropriate valuation. We appreciate situations, CMS will be able to in RVUs in strict proportion to changes when the RUC recommendations effectively adjust both emerging in time is inappropriate. provide as much detailed information technological trends and their impact on Response: We do not agree with the regarding the recommended valuations resource costs needed to deliver care to commenters’ characterization of our as possible, including thorough beneficiaries. statements, and believe it misinterprets discussions regarding physician time Response: We appreciate the our view on this matter. We specifically changes and how the RUC believes such commenters’ support for our ongoing stated in the CY 2017 proposed rule that changes should or should not impact adjustment of work RVUs based on we are not implying that the decrease in the work involved, and we consider that changes in the best information we have time as reflected in survey values must information when conducting our regarding the time resources involved in necessarily equate to a one-to-one or review of each code. furnishing individual services. We also linear decrease in newly valued work Comment: A few commenters stated agree that CMS should account for RVUs, given that intensity for any given that CMS places undue emphasis on efficiencies in the resource costs of time, procedure may change over several time and not enough emphasis on as indicated by one commenter, and years or within the intraservice period. intensity or whether a value is will endeavor to do so when we Nevertheless, we believe that since the appropriately ranked in the Medicare consider the work RVU and how the two components of work are time and fee schedule. The commenters stated effect of advancements such as emerging intensity, that absent an obvious or that CMS ignores compelling evidence technology and improvements in explicitly stated rationale for why the that work has changed if the time has surgical techniques impact the resource relative intensity of a given procedure not also changed, and that CMS uses costs of time. has specifically increased or that the codes as supporting references for new Comment: A few commenters, reduction in time is disproportionally lower values that make no clinical including the RUC, stated that all from less-intensive portions of the sense. The commenters urged CMS to adjustments to work RVUs should be procedure, that significant decreases in always consider all elements of relative solely based on the resources involved time should generally be reflected in work in every review, including time, in performing each procedure or service. decreases to work RVUs. relative intensity and relative work. The commenters stated that all Comment: A few commenters, Response: We disagree with adjustments to work RVUs should either including the RUC, stated that they commenters’ statement that CMS be work neutral to the family or result wanted to remind CMS of the Agency’s ignores compelling evidence that work in budget neutral adjustment to the and the RUC’s longstanding position has changed if the time has not also conversion factor, and that broadly that treating all components of changed. As previously stated, we are redistributing work RVUs would distort physician time as having identical not making refinements solely in the relative value system and create intensity is incorrect, and inconsistently consideration of time, and if that were unintended consequences. applying this treatment to only certain the case, changes in work RVU values Response: We agree that adjustments services under review creates inherent that we adopted would consistently be to work RVUs should be based on the payment disparities in a payment comparable to the changes in the time resources involved with each procedure system that is based on relative that we adopted, and that is not the or service, and consistent with the valuation. The commenters stated that case. It is our practice to consider all statute, the work RVUs should reflect when physician times are updated in elements of the relative work when we the relative resources costs of time and the fee schedule, the ratio of intra- are reviewing and determining work intensity. We also agree with the service time to total time, the number RVU valuations. Additionally, our commenter regarding how changes in and level of bundled post-operative review of recommended work RVUs and work RVUs affect PFS relativity. We visits, the length of pre-service, and the time inputs generally includes review of have a long-standing practice of making length of immediate post-service time various sources such as information an adjustment to the CF to account for may all potentially change for the same provided by the RUC, other public increases or decreases in work RVUs service. These changing components of commenters, medical literature, and across the PFS instead of scaling the physician time result in the physician comparative databases. work RVUs to maintain overall work intensity per minute often Comment: A few commenters, relativity. The practical effect of a changing when physician time also including the RUC, stated that they do positive adjustment to the CF is that the changes, and the commenters not agree with any suggested value of a single work RVU is greater recommended that CMS always account methodology to use a reverse building than it previously had been. In other for these nuanced variables. A few block methodology to systematically

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reduce work RVUs for services. The time is a tangible resource, particularly that vary both in intensity and in types commenters stated that any purely the time of a physician or other of patients treated, CMS ignores its formulaic approach should never be practitioner paid on the PFS, and the statutory requirement to consider time used as the primary methodology to statute specifically identifies it as such. and intensity in the valuation of value services, and that it is highly Comment: A few commenters urged services. One commenter stated that inappropriate due to the fact that CMS to always enlist the assistance of CMS does not mention how it considers, magnitude estimation was used to medical officers familiar with weights or measures intensity, and there establish work RVUs for services. procedures under review to examine is no validity to the assumption that Response: We note that a formulaic CMS staff recommendations that reject reduced time equals less work. The approach is not being used as the the RUC recommendation. Similarly, a commenter stated that it found no primary methodology to value services. few commenters also urged CMS to published evidence supporting this, and Instead, we use various methodologies work with the RUC to ensure that the states that if the same amount of work to identify values to consider relative to robust discussions and key points that is performed for a shorter period of other PFS services. We reiterate that we are discussed during RUC meetings are time, it is logical that the intensity of use the RUC-recommended values or transferred to CMS in a way that is work per unit of time increases. The the existing values as the base values. meaningful to staff to develop the commenter stated that CMS must be We then apply adjustments to the RUC- proposed relative value transparent and demonstrate why recommended values where, for recommendations. current intensity measurements are not example, the RUC’s recommendations Response: We note that the values appropriate, and if there is a more do not account for changes in time. proposed by CMS are developed accurate way to measure intensity, this Comment: Another commenter stated through consultation with, and input must be clearly elucidated with that the establishment of a time formula from CMS staff including medical evidence for superiority of the or use of reverse building block officers, who often attend RUC meetings alternative proposal. methodology as the primary method for as observers, and therefore, have had the Response: We disagree that we valuation would completely disregard opportunity to listen to the discussions discredit intensity when we establish the possibility that physicians actually that take place and key points that are work RVUs for procedures. We reiterate get better at what they do in favor of the raised during the RUC meetings. that we use RUC-recommended values erroneous conclusion that physicians Comment: One commenter stated that or existing values, which we understand only find new ways to cut corners. The the recent rejections of RUC to incorporate an assessment of commenter provided an example to recommendations by CMS to instead intensity, as the base values, and then demonstrate why time alone does not reduce the work RVUs for almost every subsequently apply adjustments as create value, and it is instead just one code, even if only by one or two necessary. Additionally, as we have component of valuation. The percent, are illogical. previously stated, we recognize that it commenter described an example of two Response: We do not agree with the would not be appropriate to develop watchmakers that make watches at suggestion that we reject the RUC- work RVUs solely based on time given different rates—one makes two watches recommended values for most codes. that intensity is also an element of work. per day, the other makes four watches Furthermore, given the numerical Additionally, if we were to disregard per day. Each watch involves the same specificity of the RUC-recommended intensity altogether, the work RVUs for number of gears, sprockets, jewels, and values and that so many PFS services all services would be developed solely escapements. One watchmaker is faster reviewed under the misvalued code based on time values, and that is than the other: More focused, more initiative are high-volume, we do not absolutely not the case. We have experienced, more agile, and able to believe that relatively minor previously stated that in cases where the accomplish fastidious work more adjustments are unimportant or illogical RUC’s recommendations do not account efficiently. At the end of one workday, because a minor adjustment to the work for changes in time, but do provide a the first watchmaker has two finished RVU of a high-volume code may have a persuasive explanation regarding why watches on the bench, while the other significant dollar impact. However, we the time has drastically changed but the has four. The commenter questioned would be interested to know if work RVU value has remained the same, that if the watches are identical, why stakeholders generally agree that the our tendency has been to use those should the faster (better) watchmaker be RUC-recommended values represent values as recommended. When the paid half the price for each watch? only rough estimates, and because of RUC’s recommendations do not account Response: We understand some that belief, minor refinements would be for changes in time, and provide no stakeholders’ interest in the considered illogical, as indicated by the explanation as to why this is maintenance of work RVUs regardless of commenter. appropriate, we have made changes to efficiencies gained. The work RVU is Comment: A few commenters stated the RUC-recommended values to not a measure of our appreciation for that they are concerned with the CMS account for changes in time. the work ethic of the physician. Instead, trend to discredit intensity when We also disagree that we ignore the the work RVU reflects the time and assigning work RVUs to procedures. statutory requirement to consider time intensity of a particular service relative These commenters stated that intensity and intensity in the valuation of to others on the PFS. For this reason, we is a key factor when specialties are services. Based on the assessments of do not agree with the implication that making work RVU recommendations CMS medical officers and other we should ignore efficiencies in time, and needs to remain an equal force reviewers, as well as upon consideration and instead believe that we are along with time in the relative value of the survey results, and the rationales obligated to recognize when efficiencies system. One commenter stated that it is in the recommendations, we make change the relative resource costs concerned that CMS is repeatedly determinations about the overall work involved in particular procedures. Of ignoring intensity discussions and valuations. We acknowledge that the course, such efficiencies can occur as picking arbitrary crosswalks to justify degree to which intensity varies among physicians become more proficient and lowering work RVU values. One different procedures is a relatively can therefore complete a service or commenter stated that by placing the subjective assessment, and we procedure in less time. We believe that same value on clearly different services understand that sometimes stakeholders

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may have a different perspective in associated with services, they should has been perceived as an appeals cases where the intensities of specify these clearly so stakeholders can process by many stakeholders. However, procedures differ. We recognize that the provide the necessary data detailing as we have previously clarified, the IWPUT measure is a derived value with changes over time. purpose of the refinement panel process specific uses for quantifying intensity. Response: As previously discussed, was to assist us in reviewing the public However, the limited way in which that our review of work RVUs and time comments on CPT codes with interim derived value is used under the RUC inputs utilizes information from various final work RVUs and to consider more valuation process, we believe reflects a resources. It generally includes, but is fully the interests of the specialty general consensus that there are not not limited to a review of information societies who provide input on RVU widely accepted metrics for intensity. provided by the RUC, HCPAC, and other work time and intensity with the As a part of recommendations for public commenters, medical literature, budgetary and redistributive effects that misvalued codes, we welcome any and comparative databases, as well as could occur if we accepted extensive information from stakeholders for us to comparison with other codes with the increases in work RVUs across a broad more objectively measure intensity. PFS, consultation with other physicians range of services. From our perspective, Comment: A few commenters stated and health care professionals within the objective of the refinement panel has that they are concerned with the current CMS and the federal government, as long been to provide a needed venue for implied methodology that the 25th well as Medicare claims data. stakeholders to present any new clinical survey percentile is the ceiling for RUC Additionally, we also assess the information that was not available at the recommendations, and stated that if methodology and data used to develop time of the RUC valuation for interim codes are continually sent forth for re- the recommendations submitted to us final values in order that we arrive at survey and the 25th percentile is the by the RUC and other public the most appropriate final valuation, ceiling, a built in reduction is applied commenters and the rationale for the especially since the initial values for to all surveyed codes just by the nature recommendations. However, we such codes were generally established of surveying the codes, regardless of continue to seek information regarding approximately 2 months prior to being other factors. the best sources of objective, routinely- used for Medicare payment. In recent Response: We disagree with updated, auditable, and robust data years, we have continually observed commenters’ statement that the 25th regarding the resource costs of that the material presented to the survey percentile is the ceiling for RUC furnishing PFS services. refinement panel largely raised and recommendations. We note that, as We thank the commenters for their discussed issues and perspective previously stated in the CY 2011 final feedback. We did not receive any already included as part of the RUC rule with comment period (75 FR comments regarding specific potential meetings and considered by us. 73328), we had concerns that surveys alternatives to making the adjustments We believe that our new process, in conducted on existing codes produced that would recognize overall estimates which we propose the vast majority of predictable results, and upon clinical of work in the context of changes in the code values in the proposed rule for review of a number of these situations, resource of time for particular services public comment on those proposed we were concerned over the validity of as requested. However, we appreciate values prior to their taking effect, the survey results since the survey the commenters’ sharing their concerns provides stakeholders and the public values often were very close to the and suggestions and will continue to with several opportunities to present current code values. Increasingly, the consider them as we continue data or information that might affect RUC is choosing to recommend the 25th examining the valuation of services, and code valuation. We believe that this is percentile survey value, potentially as we explore the best way to address generally consistent with the purpose of responding to the same concern we have these issues. the rulemaking process and reflects our identified, rather than recommending 3. Requests for Refinement Panel efforts to increase transparency and the median survey value that had accountability to the public. We also historically been the most commonly Consistent with the policy finalized in note that we continue to seek new used. We reiterate that this does not the CY 2016 PFS final rule with information that is relevant to valuation designate the 25th percentile as the comment period, we have retained the of particular services, including those ceiling, rather suggests that in many Refinement Panel process for use with with values recently finalized, for use in instances the 25th percentile is the most codes with interim final values where future rulemaking. We believe that appropriate since it is more frequently additional input by the panel is likely notice and comment rulemaking being identified through the RUC to add value as a supplement to notice provides the most appropriate means for process as the recommended value. and comment rulemaking. Because there valuing services under the PFS. We note Comment: One commenter stated that are no codes with interim final values that in several instances in this final the time data obtained through the RUC in this final rule, the refinement panel rule, thoughtful and informative survey process based on subjective is not necessary for CY 2017. We note comments have helped us to finalize physician perceptions of time, may not that many commenters requested values for CY 2017 that we believe are be the most accurate data available on inclusion of codes with proposed values improved from those we had proposed. intraoperative time. The commenter for a refinement panel. While these In many cases, these changes reflect the stated that CMS should be open to requests are not consistent with our RUC-recommended value. Therefore, we reviewing additional sources of established process, given the number of urge commenters to review this objective validated time data, and that requests we received, we are addressing information and continue to consider such sources might include peer them here. Many commenters appear to how we might continue to improve the reviewed and published studies of believe that that the purpose of the notice and comment rulemaking process comparative surgery times amongst refinement panel process was to serve as rather than establish a process outside different procedures in the same a kind of ‘‘appeals’’ or reconsideration of notice and comment rulemaking. institution using standardized metrics. process outside of notice and comment Table 27 contains a list of codes for Another commenter stated that if CMS rulemaking and that we have effectively which we proposed work RVUs; this seeks specific information to eliminated a useful appeals process. We includes all RUC recommendations substantiate time and intensity changes understand that the refinement panel received by February 10, 2016, and

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codes for which we established interim to particular codes are addressed in the clarified this principle over several final values in the CY 2016 PFS final portions of this section that are years of rulemaking, indicating that we rule with comment period. When the dedicated to particular codes. We note consider equipment time as the time proposed work RVUs vary from those that for each refinement, we indicate the within the intraservice period when a recommended by the RUC or for which proposed impact on direct costs for that clinician is using the piece of we do not have RUC recommendations, service. We note that, on average, in any equipment plus any additional time that we address those codes in the portions case where the impact on the direct cost the piece of equipment is not available of this section that are dedicated to for a particular refinement is $0.32 or for use for another patient due to its use particular codes. The final work RVUs less, the refinement has no impact on during the designated procedure. For and work time and other payment the proposed PE RVUs. This calculation those services for which we allocate information for all CY 2017 payable considers both the impact on the direct cleaning time to portable equipment codes are available on the CMS Web site portion of the PE RVU, as well as the items, because the portable equipment under downloads for the CY 2017 PFS impact on the indirect allocator for the does not need to be cleaned in the room final rule at http://www.cms.gov/ average service. We also note that nearly where the service is furnished, we do physicianfeesched/downloads/. half of the proposed refinements listed not include that cleaning time for the in Table 28 result in changes under the remaining equipment items, as those 4. Methodology for Proposing the Direct $0.32 threshold and are unlikely to items and the room are both available PE Inputs To Develop PE RVUs result in a change to the proposed for use for other patients during that a. Background RVUs. time. In addition, when a piece of On an annual basis, the RUC provides We also note that the final direct PE equipment is typically used during follow-up post-operative visits included us with recommendations regarding PE inputs for CY 2017 are displayed in the in the global period for a service, the inputs for new, revised, and potentially CY 2017 direct PE input database, equipment time would also reflect that misvalued codes. We review the RUC- available on the CMS Web site under use. recommended direct PE inputs on a the downloads for the CY 2017 final rule at www.cms.gov/ We believe that certain highly code by code basis. Like our review of technical pieces of equipment and recommended work RVUs, our review PhysicianFeeSched/. The inputs displayed there have also been used in equipment rooms are less likely to be of recommended direct PE inputs used during all of the preservice or generally includes, but is not limited to, developing the final CY 2017 PE RVUs as displayed in Addendum B. postservice tasks performed by clinical a review of information provided by the labor staff on the day of the procedure RUC, HCPAC, and other public b. Common Refinements (the clinical labor service period) and commenters, medical literature, and (1) Changes in Work Time are typically available for other patients comparative databases, as well as a even when one member of the clinical comparison with other codes within the Some direct PE inputs are directly staff may be occupied with a preservice PFS, consultation with physicians and affected by revisions in work time. or postservice task related to the health care professionals within CMS Specifically, changes in the intraservice procedure. We also note that we believe and the federal government, as well as portions of the work time and changes these same assumptions would apply to Medicare claims data. We also assess in the number or level of postoperative inexpensive equipment items that are the methodology and data used to visits associated with the global periods used in conjunction with and located in develop the recommendations result in corresponding changes to a room with non-portable highly submitted to us by the RUC and other direct PE inputs. The direct PE input technical equipment items since any public commenters and the rationale for recommendations generally correspond items in the room in question would be the recommendations. When we to the work time values associated with available if the room is not being determine that the RUC’s services. We believe that inadvertent occupied by a particular patient. For recommendations appropriately discrepancies between work time values additional information, we refer readers estimate the direct PE inputs (clinical and direct PE inputs should be refined to our discussion of these issues in the labor, disposable supplies, and medical or adjusted in the establishment of CY 2012 PFS final rule with comment equipment) required for the typical proposed direct PE inputs to resolve the period (76 FR 73182) and the CY 2015 service, are consistent with the discrepancies. PFS final rule with comment period (79 principles of relativity, and reflect our (2) Equipment Time FR 67639). payment policies, we use those direct PE inputs to value a service. If not, we Prior to CY 2010, the RUC did not (3) Standard Tasks and Minutes for refine the recommended PE inputs to generally provide CMS with Clinical Labor Tasks better reflect our estimate of the PE recommendations regarding equipment In general, the preservice, resources required for the service. We time inputs. In CY 2010, in the interest intraservice, and postservice clinical also confirm whether CPT codes should of ensuring the greatest possible degree labor minutes associated with clinical have facility and/or nonfacility direct of accuracy in allocating equipment labor inputs in the direct PE input PE inputs and refine the inputs minutes, we requested that the RUC database reflect the sum of particular accordingly. provide equipment times along with the tasks described in the information that Our review and refinement of RUC- other direct PE recommendations, and accompanies the RUC-recommended recommended direct PE inputs includes we provided the RUC with general direct PE inputs, commonly called the many refinements that are common guidelines regarding appropriate ‘‘PE worksheets.’’ For most of these across codes, as well as refinements that equipment time inputs. We continue to described tasks, there are a standardized are specific to particular services. Table appreciate the RUC’s willingness to number of minutes, depending on the 28 details our finalized refinements of provide us with these additional inputs type of procedure, its typical setting, its the RUC’s direct PE recommendations at as part of its PE recommendations. global period, and the other procedures the code-specific level. In this final rule, In general, the equipment time inputs with which it is typically reported. The we address several refinements that are correspond to the service period portion RUC sometimes recommends a number common across codes, and refinements of the clinical labor times. We have of minutes either greater than or less

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than the time typically allotted for item be created and has facilitated our paid invoices). In cases where the certain tasks. In those cases, we review pricing of that item by working with the information provided on the item allows the deviations from the standards and specialty societies to provide us copies us to identify clinically appropriate any rationale provided for the of sales invoices. For CY 2017, we proxy items, we might use existing deviations. When we do not accept the received invoices for several new items as proxies for the newly RUC-recommended exceptions, we supply and equipment items. Tables 30 recommended items. In other cases, we refine the proposed direct PE inputs to and 31 detail the invoices received for have included the item in the direct PE conform to the standard times for those new and existing items in the direct PE input database without any associated tasks. In addition, in cases when a database. As discussed in section II.A. price. Although including the item service is typically billed with an E/M of this final rule, we encourage without an associated price means that service, we remove the preservice stakeholders to review the prices the item does not contribute to the clinical labor tasks to avoid duplicative associated with these new and existing calculation of the proposed PE RVU for inputs and to reflect the resource costs items to determine whether these prices particular services, it facilitates our of furnishing the typical service. appear to be accurate. Where prices ability to incorporate a price once we In general, clinical labor tasks fall into appear inaccurate, we encourage obtain information and are able to do so. one of the categories on the PE stakeholders to provide invoices or (6) Service Period Clinical Labor Time worksheets. In cases where tasks cannot other information to improve the in the Facility Setting be attributed to an existing category, the accuracy of pricing for these items in tasks are labeled ‘‘other clinical the direct PE database during the 60-day Generally speaking, our proposed activity.’’ We believe that continual public comment period for this final inputs did not include clinical labor addition of new and distinct clinical rule. We expect that invoices received minutes assigned to the service period labor tasks each time a code is reviewed outside of the public comment period because the cost of clinical labor during under the misvalued code initiative is would be submitted by February 10th of the service period for a procedure in the likely to degrade relativity between the following year for consideration in facility setting is not considered a newly reviewed services and those with future rulemaking, similar to our new resource cost to the practitioner since already existing inputs. This is because process for consideration of RUC Medicare makes separate payment to the codes more recently reviewed would be recommendations. facility for these costs. We address more likely to have a greater number of We remind stakeholders that due to proposed code-specific refinements to clinical labor tasks as a result of the the relativity inherent in the clinical labor in the individual code general tendency to increase the number development of RVUs, reductions in sections. of clinical labor tasks. To mitigate the existing prices for any items in the (7) Procedures Subject to the Multiple potential negative impact of these direct PE database increase the pool of Procedure Payment Reduction (MPPR) additions, we review these tasks to direct PE RVUs available to all other and the OPPS Cap determine whether they are fully PFS services. Tables 30 and 31 also distinct from existing clinical labor include the number of invoices We note that the public use files for tasks, typically included for other received, as well as the number of the PFS proposed and final rules for clinically similar services under the nonfacility allowed services for each year display both the services PFS, and thoroughly explained in the procedures that use these equipment subject to the MPPR lists on diagnostic recommendation. For those tasks that do items. We provide the nonfacility cardiovascular services, diagnostic not meet these criteria, we do not accept allowed services so that stakeholders imaging services, diagnostic these newly recommended clinical labor will note the impact the particular price ophthalmology services and therapy tasks. might have on PE relativity, as well as services and the list of procedures that to identify items that are used meet the definition of imaging under (4) Recommended Items That Are Not frequently, since we believe that section 1848(b)(4)(B) of the Act, and Direct PE Inputs stakeholders are more likely to have therefore, are subject to the OPPS cap In some cases, the PE worksheets better pricing information for items used for the upcoming calendar year. The included with the RUC more frequently. A single invoice may public use files for CY 2017 are recommendations include items that are not be reflective of typical costs and we available on the CMS Web site under not clinical labor, disposable supplies, encourage stakeholders to provide downloads for the CY 2017 PFS final or medical equipment or that cannot be additional invoices so that we might rule at http://www.cms.gov/Medicare- allocated to individual services or identify and use accurate prices in the Fee-for-Service-Payment/ patients. We have addressed these kinds development of PE RVUs. PhysicianFeeSched/PFSFederal- of recommendations in previous In some cases, we do not use the price Regulation-Notices.html. rulemaking (78 FR 74242), and we do listed on the invoice that accompanies 4. Specialty-Mix Assumptions for not use items included in these the recommendation because we Proposed Malpractice RVUs recommendations as direct PE inputs in identify publicly available alternative the calculation of PE RVUs. prices or information that suggests a The final CY 2017 malpractice different price is more accurate. In these crosswalk table is displayed in the (5) New Supply and Equipment Items cases, we include this in the discussion public use files for the PFS final rule. The RUC generally recommends the of these codes. In other cases, we cannot The public use files for CY 2017 are use of supply and equipment items that adequately price a newly recommended available on the CMS Web site under already exist in the direct PE input item due to inadequate information. downloads for the CY 2017 PFS final database for new, revised, and Sometimes, no supporting information rule at http://www.cms.gov/Medicare- potentially misvalued codes. Some regarding the price of the item has been Fee-for-Service-Payment/ recommendations, however, include included in the recommendation. In PhysicianFeeSched/PFSFederal- supply or equipment items that are not other cases, the supporting information Regulation-Notices.html. The table lists currently in the direct PE input does not demonstrate that the item has the CY 2017 HCPCS codes and their database. In these cases, the RUC has been purchased at the listed price (for respective source codes used to set the historically recommended that a new example, vendor price quotes instead of final CY 2017 MP RVUs where the

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source code for this calculation deviates services compared to moderate sedation, We did not receive any comments in from the source code for the utilization payment for anesthesia services should response to our proposed valuation on otherwise used for purposes of PFS not be lower than the values established CPT codes 10035 and 10036 and we are ratesetting. The MP RVUs for all PFS for moderate sedation. finalizing the clinical labor task and services and the utilization crosswalk One commenter stated that CMS’ work RVUs as proposed. used to identify the source codes for all perception that these codes are misvalued is related to the distinction (3) Removal of Nail Plate (CPT Code other codes are reflected in Addendum 11730) B on the CMS Web site at https:// between screening, diagnostic, and www.cms.gov/Medicare/Medicare-Fee- therapeutic endoscopies. The We identified CPT code 11730 for-Service-Payment/ commenter further stated that there are through a screen of high expenditures PhysicianFeeSched/. no differences in the clinical risk and by specialty. The HCPAC recommended anesthesia preparation regardless of the a work RVU of 1.10. We believed the 5. Valuation of Specific Codes indication for these procedures and recommendation for this service (1) Anesthesia Services Furnished in suggested that the current base unit overestimates the work involved in Conjunction With Lower value of 5 units for CPT codes 00740 performing this procedure, specifically Gastrointestinal (GI) Procedures (CPT and 00810 is appropriate and should be given the decrease in physician Codes 00740 and 00810) maintained. Another commenter stated intraservice and total time concurrently that the frequency of use of separate recommended by the HCPAC. We CPT codes 00740 and 00810 are used anesthesia services concurrent with believed that a work RVU of 1.05, which to report anesthesia furnished in colonoscopy procedures is not due to corresponds to the 25th percentile of the conjunction with lower gastrointestinal any potential misvaluation, but rather survey results, more accurately (GI) procedures. In the CY 2016 PFS due to changes in Medicare coverage represents the time and intensity of proposed rule (80 FR 41686), we and payment policies that encourage furnishing the service. To further discussed that in reviewing Medicare Medicare beneficiaries to undergo support the validity of the use of the claims data, a separate anesthesia screening colonoscopies. 25th percentile of the survey, we service is typically reported more than Response: We appreciate the identified two crosswalk codes, CPT 50 percent of the time that various information provided by commenters. code 20606 (Arthrocentesis, aspiration colonoscopy procedures are reported. We continue to encourage feedback and/or injection, intermediate joint or We discussed that given the significant from interested parties and specialty bursa), with a work RVU of 1.00, and change in the relative frequency with societies, all of which we will take CPT code 50389 (Removal of which anesthesia codes are reported under consideration for future nephrostomy tube, requiring with colonoscopy services, we believed rulemaking. fluoroscopic guidance), with a work the relative values of the anesthesia RVU of 1.10, both of which have services should be reexamined. We (2) Soft Tissue Localization (CPT Codes identical intraservice times, similar total proposed to identify CPT codes 00740 10035 and 10036) times and similar intensity. We noted and 00810 as potentially misvalued and In the CY 2016 PFS final rule with that our proposed work RVU of 1.05 for sought public comment regarding comment period, we established the CPT code 11730 falls halfway between valuation for these services. RUC-recommended work value as the work RVUs for these two crosswalk The RUC recommended maintaining interim final for CPT codes 10035 and codes. CPT code 11730 may be reported the base unit value of 5 as an interim 10036. We also made standard with add-on CPT code 11732 to report base value for both CPT code 00740 and refinements to remove duplicative performance of the same procedure for 00810 on an interim basis, due to their clinical labor and utilize standard each additional nail plate procedure. concerns about the specialty societies’ equipment time formulas for the PACS Since CPT code 11732 was not surveys. The RUC suggested that the workstation proxy (ED050). reviewed by the HCPAC for CY 2017, typical patient vignettes used in the Comment on the CY 2016 PFS final we proposed a new work value to surveys for both CPT codes 00740 and rule with comment period: A maintain the consistency of this add-on 00810 were not representative of current commenter stated that the clinical labor code with the base code, CPT code typical practice and recommended that task ‘‘Review/read X-ray, lab, and 11730. We proposed to remove 2 the codes be resurveyed with updated pathology reports’’ occurs during the minutes from the physician intraservice vignettes. We stated in the CY 2017 preservice period, and it is a separate time to maintain consistency with the proposed rule that we believed it activity than ‘‘Review examination with HCPAC-recommended reduction of 2 premature to propose any changes to the interpreting MD’’, which occurs during minutes from the physician intraservice valuation of CPT codes 00740 and the service period. time period for the base code. We are 00810, continued to believe that these Response in the CY 2017 PFS using a crosswalk from the value for services are potentially misvalued, and proposed rule: We continued to believe CPT code 77001 (Fluoroscopic guidance sought additional input from that the clinical labor was duplicative for central venous access device stakeholders for consideration during with the clinical labor for ‘‘Review placement, replacement (catheter only future rulemaking. examination with interpreting MD’’ or complete), or removal (includes Comment: Commenters were because we believed that the two fluoroscopic guidance for vascular supportive of CMS’ proposal to descriptors detailed the same clinical access and catheter manipulation, any maintain the current values for CPT labor activity taking place, rather than necessary contrast injections through codes 00740 and 00810 for CY 2017. two separate and distinct tasks. access site or catheter with related One commenter requested that CMS In the CY 2017 proposed rule, we venography radiologic supervision and ensure that reimbursement for proposed to maintain our previous interpretation, and radiographic anesthesia services remains adequate to refinement to 0 minutes for this clinical documentation of final catheter compensate providers for the cost of labor task for CPT codes 10035 and position) (List separately in addition to furnishing these services. Commenters 10036. We also proposed to maintain code for primary procedure)), which has also stated that due to greater the interim final work RVUs for CPT similar physician intraservice and total complexity of furnishing anesthesia codes 10035 and 10036. time values; therefore, we proposed a

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work RVU of 0.38 for CPT code 11732. intraservice and total time supports a RUC-recommended work RVU of 6.50 As further support for this proposal, we reduction in our estimation of the only represents a 27 percent reduction noted that this proposed RVU reduction physician work value of furnishing this relative to the previous work RVU of is similar to the value obtained by service. 8.95. To develop a work RVU for this subtracting the incremental difference Comment: The HCPAC stated that it service, we used a crosswalk from CPT in the current and recommended work did not support the proposed decrease code 19298 (Placement of radiotherapy RVUs for the base code from the current in the work RVU for CPT code 11732. after loading brachytherapy catheters value of CPT code 11732. Response: We welcome any (multiple tube and button type) into the We proposed to use the HCPAC- additional input as to the appropriate breast for interstitial radioelement recommended direct PE inputs for CPT valuation of CPT code 11732. At this application following (at the time of or code 11730. We proposed to apply some time, we continue to believe that a work subsequent to) partial mastectomy, of the HCPAC-recommended RVU of 0.38 is appropriate, considering includes imaging guidance), since we refinements for CPT code 11730 to CPT its relationship to CPT code 11730. We believe the codes share similar intensity code 11732, including the removal of proposed values for CPT code 11732 and total time and the same intraservice the penrose drain (0.25 in × 4 in), based on its being an add-on code for time of 60 minutes. Therefore, for CY lidocaine 1%–2% inj (Xylocaine), CPT code 11730. We remind 2017, we proposed a work RVU of 6.00 applicator (cotton-tipped, sterile) and commenters and stakeholders that they for CPT code 20245. silver sulfadiazene cream (Silvadene), as may nominate this code family as Comments: Several commenters, well as the reduction of the swab-pad, potentially misvalued if they believe including the RUC, stated their alcohol from 2 to 1. In addition, we that both codes should be evaluated objection to the proposed crosswalk, proposed not to include the through the standard process, which indicating that it underestimated the recommended supply items ‘‘needle, would involve use of physician survey total time by 10 minutes and the 30g, and syringe, 10–12ml’’ since other data and input from the HCPAC for both physician work involved in furnishing similar items are present, and we codes. We are finalizing work RVUs of the service. Commenters recommended believe inclusion of these additional 1.05 for CPT code 11730 and 0.38 for CMS accept the RUC-recommended supply items would be duplicative. For CPT code 11732, as well as the work RVU of 6.50. clinical labor, we proposed to assign 8 proposed PE refinements. The RUC also noted the current time minutes to ‘‘Assist physician in of CPT code 20245 was based on a performing procedure’’ to maintain a (4) Bone Biopsy Excisional (CPT Code survey of 35 individuals more than 15 reduction that is proportionate to that 20245) years ago and due to the previous recommended for CPT code 11730. For In CY 2014, CPT code 20245 was flawed survey, the resulting IWPUT was the supply item ‘‘ethyl chloride spray,’’ identified by the RUC’s 10-Day Global almost zero. Given these discrepancies, we believed that the listed input price Post-Operative Visits Screen. the surveyed time of 60 minutes better of $4.40 per ounce overestimates the For CY 2017, the RUC recommended reflects an appropriate level of intensity cost of this supply item, and we a work RVU of 6.50 for CPT code 20245, and complexity (IWPUT= 0.071) for this solicited comment on the accuracy of including a change in global period service relative to other 0-day global this supply item price. Finally, we from 10 to 0 days. We disagreed with procedures. proposed to add two equipment items as this value given the significant was done in the base code, basic reductions in the intraservice time, total Another commenter stated concern instrument pack and mayo stand, and time, and the change in the office visits that the values proposed by CMS have proposed to adjust the times for all assuming the change in global period. been arrived at using methodologies that pieces of equipment to eight minutes to The intraservice and total times were are not consistent with the RUC- reflect the clinical service period time. decreased by approximately 33 and 53 recommended values, and therefore, are Comment: A commenter states that percent respectively; while the not appropriately relative to other the work for CPT code 11730 has not elimination of three post-operative visits similar services. changed since the previous (one CPT code 99214 and two CPT code Response: Thank you for your recommendation, thus maintenance of a 99213 visits) alone would reduce the comments. We present the information work RVU of 1.10 is proper. overall work RVU by at least 38 percent in Table 16 to illustrate the differences Response: We continue to believe that under the reverse building block between the CMS crosswalked code and the HCPAC-recommended reduction in methodology. We also note that the the additional RUC comparator codes.

TABLE 16—CROSSWALK FOR CPT CODE 20245

Intra-service CPT code Descriptor time Total time Work RVU

20245 ...... Bone Biopsy Excisional ...... 60 160 * 6.50 19298 ...... Place Breast Rad Tube/Cath ...... 60 169 6.00 36247 ...... Ins Cath ABDL/-Ext Art 3RD ...... 60 131 6.29 43262 ...... Endocholangiopancreatograp ...... 60 138 6.60 * RUC recommended value.

Although the total times for CPT which have 22–29 minutes less total 4.94 RVUs when the code was revalued codes 19298 and 20245 are not time. with a 0-day global period. identical, we continue to believe it is a We note that according to the most For CY 2017, we are finalizing the more accurate comparison than the recent survey, respondents lowered the work RVU of 6.00 for CPT code 20245. additional codes submitted by the RUC, work RVU of the 25th percentile, which we typically accept, from 6.06 RVUs to

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(5) Insertion of Spinal Stability 36832). We consider multiple factors intravascular stent(s) (except lower Distractive Device (CPT Codes 22867, when identifying appropriate crosswalk extremity artery(s) for occlusive disease, 22868, 22869, and 22870) codes. We note that RUC’s crosswalk, cervical carotid, extracranial vertebral or For CY 2016, the CPT Editorial Panel CPT code 29915, had very low service intrathoracic carotid, intracranial, or converted two Category III codes to utilization, 355 in 2015, and was last coronary), open or percutaneous, Category I codes describing the insertion reviewed by CMS and the RUC in April including radiological supervision and of an interlaminar/interspinous process 2010. CPT code 36832, in contrast, had interpretation and including all stability device (CPT codes 22867 and service utilization of 21,529 in 2015, angioplasty within the same vessel, 22869) and developed two and was most recently reviewed in when performed; each additional artery corresponding add-on codes (CPT codes October 2013. We considered the (List separately in addition to code for combination of these factors in choosing primary procedure)), which is similar in 22868 and 22870). The RUC a crosswalk and determining a proposed time and intensity to the work described recommended a work RVU of 15.00 for work RVU. Commenters did not present by CPT code 22853. CPT code 22867, 4.00 for CPT code any additional clinical information or Comment: Several commenters 22868, 7.39 for CPT code 22869, and data about this code that would lead us disagreed with our proposed valuation 2.34 for CPT code 22870. to reconsider our proposed valuation; of the work RVU of 4.25 for CPT code We believe that the RUC therefore, we are finalizing the work 22853 rather than the RUC- recommendations for CPT codes 22867 RVU of 13.50 for CPT code 22867. recommended work RVU of 4.88. They and 22869 overestimate the work With regard to CPT code 22869, we requested clarification regarding our involved in furnishing these services. disagree that the RUC crosswalk to CPT crosswalk for this new code to CPT code We believe that a crosswalk to CPT code code 29880 is a closer comparison than 37237 instead of the RUC-recommended 36832 (Revision, open, arteriovenous CPT code 29881. The intraservice time crosswalk of CPT code 57267. fistula; without thrombectomy, for the newly created CPT code 22869 Response: We take many factors into autogenous or nonautogenous dialysis (43 minutes) is between that of the RUC consideration when valuing a work RVU graft (separate procedure)), which has a recommended crosswalk CPT code for a new code. We note that CPT code work RVU of 13.50 is a more accurate 29880 (45 minutes) and the CMS 57267 and CPT code 37237 have comparison. CPT code 36832 is similar crosswalk CPTcode 29881 (40 minutes). identical intraservice times and very in total time, work intensity, and Total time for CPT code 29881, similar total work times. We note that number of visits to CPT code 22867. however, is identical to total time for CPT code 37237 was most recently This crosswalk is supported by the ratio CPT code 22869 (194 minutes), whereas valued in April 2013, whereas the RUC between total time and work in the key the RUC recommended crosswalk CPT crosswalk CPT code 57267 was last reference service, CPT code 63047 code 29880 has a higher total time (199 reviewed in 2004. We continue to (Laminectomy, facetectomy and minutes). We continue to believe, believe that CPT code 37237 is an foraminotomy (unilateral or bilateral therefore, that our crosswalk is appropriate crosswalk for valuing the with decompression of spinal cord, appropriate and we are finalizing the new CPT code 22859. Therefore, we are cauda equina and/or nerve root[s], [eg, proposed work RVU of 7.03 for CPT finalizing our proposed work RVU of spinal or lateral recess stenosis]), single code 22869. 4.25 for CPT code 22853. vertebral segment; lumbar). Therefore, Comment: We received several we proposed a work RVU of 13.50 for (6) Biomechanical Device Insertion (CPT comments objecting to our proposed CPT code 22867. For CPT code 22869, Codes 22853, 22854, and 22859) work RVU of 5.50 for CPT code 22859, we believed that CPT code 29881 For CY 2016, the CPT Editorial Panel which is identical to the work RVU (Arthroscopy, knee, surgical; with established three new Category I add-on proposed by the RUC and accepted by meniscectomy (medial OR lateral, codes and deleted one code to provide CMS for CPT code 22854. Commenters including any meniscal shaving) a more detailed description of the provided detailed descriptions of the including debridement/shaving of placement and attachment of two procedures in an effort to articular cartilage (chondroplasty), same biomechanical spinal devices. For CPT demonstrate the higher intensity or separate compartment(s), when code 22853, the RUC recommended a required by CPT code 22859 compared performed) is an appropriate crosswalk work RVU of 4.88. For CPT codes 22854 with CPT code 22854, thereby justifying based on clinical similarity, as well as and 22859, the RUC-recommended work the RUC-recommended work RVU of intensity and total time. CPT code RVUs are 5.50 and 6.00, respectively. 6.00 for CPT code 22859. Several 29881 has a work RVU of 7.03; In reviewing the code descriptors, commenters expressed confusion about therefore, we proposed a work RVU of descriptions of work and vignettes the descriptors for all three of the new 7.03 for CPT code 22869. We proposed associated with CPT codes 22854 and CPT codes (CPT codes 22853, 22854, the RUC-recommended work RVU for 22859, we concluded that the two and 22859), in general, and stated their CPT codes 22868 and 22870 without procedures, in addition to having concern that the code descriptors do not refinement. identical work time, contain many clearly differentiate the work involved Comment: Several commenters clinical similarities and do not have in furnishing the services. disagreed with our proposed valuation quantifiable differences in overall Response: While we are somewhat of the work RVU for CPT codes 22867 intensity. Therefore, we proposed the persuaded by commenters’ detailed and 22869. They stated that the RUC RUC-recommended work RVU of 5.50 descriptions of the two procedures and crosswalk for each of these codes, for both CPT code 22854 and CPT code the higher intensity of work involved in respectively, is either identical to or a 22859. We believe that the RUC- furnishing CPT code 22859 compared better match than the proposed CMS recommended work RVU of 4.88 for with CPT code 22854, we are concerned crosswalk. CPT code 22853 overestimates the work about a substantive disagreement Response: We recognize that the RUC in the procedure relative to the other between the RUC and survey crosswalk of CPT code 29915 for CPT codes in the family. We proposed a respondents about the intensities of code 22867 has a total time that is more work RVU of 4.25 for CPT code 22853 work involved in furnishing the services similar to the new code than the based a crosswalk from CPT code 37237 described by these new codes. The RUC crosswalk we proposed (CPT code (Transcatheter placement of an and the survey respondents valued the

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relative intensities of the two codes in Comment on the CY 2016 PFS final RVU for CPT code 26357. One the reverse order. The survey results rule with comment period: We received commenter stated that the CMS indicated a work RVU of 8.16 (with 25th several comments regarding the interim crosswalk to CPT code 27654 had less percentile of 7.0) for CPT code 22854 final work values for this family of total time and resulted in an and a work RVU of 8.0 (with 25th codes. One commenter stated that it was inappropriately lower derived intensity. percentile of 6.0) for CPT code 22859. inappropriate to use time ratios to This commenter urged CMS to adopt the The RUC reviewed the survey results evaluate CPT code 26356 as it was last RUC-recommended work value. and agreed that respondents overvalued valued in 1995, noting that there was an Another commenter stated that a better the work involved in performing CPT anomalous relationship between the crosswalk for CPT code 26357 would be code 22854. The RUC-recommended current work RVU and the imputed time CPT code 25608 (Open treatment of work RVU for CPT code 22854, which components in the RUC database. This distal radial intra-articular fracture or we are accepting as recommended, was commenter also pointed out that when epiphyseal separation), the next code in established through a crosswalk to CPT the previous time was developed, the same upper extremity family that code 37234. We agree that this is an fabrication of a splint was considered to CMS used for the initial crosswalk. This appropriate crosswalk and valuation of be part of the intraservice work, while commenter stated that the CMS this service. For CPT code 22859, the in the current survey instrument, the crosswalk for CPT code 26357 created a RUC also believed that the survey fabrication of the splint is considered to rank order anomaly in terms of intensity recommended work RVU of 8.0 was be part of the postservice work since it within this family, and that the overvalued. The RUC recommended the is a dressing. This commenter urged commenter’s suggested crosswalk would 25th percentile of survey results, with a CMS to adopt the RUC create two pairs of matched codes, work RVU of 6.0. We find it difficult to recommendations. A different survey CPT codes 26356/26357 with reconcile the conflicting valuations by commenter agreed that the CMS crosswalk CPT codes 25607/25608. the survey and the RUC of the absolute crosswalk to CPT code 25607 was an Response in the CY 2017 PFS and relative intensity of these new appropriate crosswalk for CPT code proposed rule: We appreciate the codes. 26356 and supported the CMS work suggested crosswalk from the In addition to the survey results and RVU of 9.56. commenters, and we agree that the RUC recommendations, we reviewed Response in the CY 2017 PFS choice of the initial CMS crosswalk the descriptors of these codes and agree proposed rule: We appreciate the creates a rank order anomaly within the with commenters who found them support from the commenter. We family in terms of intensity. As a result, vague and unclear. We share the continue to believe that our crosswalk after consideration of comments concern of stakeholders who indicated for this code is an appropriate choice, received, we proposed to instead value that the lack of differentiation in the due to our estimate of overall work CPT code 26357 at the 25th percentile codes may lead to inconsistent use and between CPT code 26356 and CPT code survey work RVU of 11.00 for CY 2017. reporting. 25607. We appreciate the commenters’ This valuation corrects the anomalous Given the disagreement between the concerns regarding the time ratio intensity within the Repair Flexor RUC and survey respondents regarding methodologies and have responded to Tendon family of codes, and preserves the order and level of intensity of these these concerns about our methodology the RUC-recommended increment services, along with confusion about the in section II.L of this final rule. between CPT codes 26356 and 26357. code descriptors, we find that valuing Although we note the commenter’s Comment on the CY 2016 PFS final the services of 22854 and 22859 statement about how the service period rule with comment period: The differently from each another is difficult in which fabrication of a splint takes to justify. Therefore, we are finalizing place may have evolved over time, we commenters agreed that the RUC- our proposed work RVU of 5.50 for CPT do not agree that this task would be recommended increment of 1.60 was code 22859. responsible for a decrease in appropriate for the work RVU of CPT intraservice survey time, as the code 26358 when added to the work (7) Repair Flexor Tendon (CPT Codes RVU of CPT code 26357. However, 26356, 26357, and 26358) postservice survey time for CPT code 26356 remained unchanged at 30 commenters stated that this increment In the CY 2016 PFS final rule with minutes. If the decrease in intraservice of 1.60 should be added to the RUC- comment period, we established an time had been due to the shift of recommended work value for CPT code interim final work RVU of 9.56 for CPT splinting from the intraservice period to 26357, and not the CMS refined value code 26356 after considering both its the postservice period, then we would from the CY 2016 PFS final rule with similarity in time to CPT code 25607 have expected to see an increase in the comment period. (Open treatment of distal radial extra- postservice period minutes. However, Response in the CY 2017 PFS articular fracture) and the recommended they remained exactly the same in the proposed rule: We also continue to reduction in time relative to the current physician survey for CPT 26356. As we believe that the increment of 1.60 is times assumed for this procedure. We wrote earlier in this section, we believe appropriate for the work RVU of CPT established an interim final work RVU in the validity of using pre-existing time code 26358. After consideration of of 10.53 for CPT code 26357 based on values as a point of comparison, and we comments received, we therefore a direct crosswalk from CPT code 27654 believe that we should account for proposed to set the work RVU for this (Repair, secondary, Achilles tendon, efficiencies in time when the code at 12.60 for CY 2017, based on the with or without graft), as we believed recommended work RVU does not increment of 1.60 from CPT code that this work RVU better reflected the account for those efficiencies. After 26357’s proposed work RVU of 11.00. changes in time for this procedure. For consideration of comments received, we In the CY 2017 proposed rule, we the last code in the family, we proposed to maintain CPT code 26356 at proposed to maintain the current direct established an interim final work RVU its current work RVU of 9.56 for CY PE inputs for all three codes. of 12.13 for CPT code 26358, based on 2017. The following is a summary of the the RUC-recommended increment of Comment on the CY 2016 PFS final comments we received regarding our 1.60 work RVUs relative to CPT code rule with comment period: Several proposed valuation of the Repair Flexor 26357. commenters disagreed with the work Tendon codes:

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Comment: One commenter expressed we proposed a work RVU of 1.53 for code are taken into consideration when support for the proposed work RVU for CPT code 27197. For CPT code 27198, determining the appropriate global the flexor tendon codes. we proposed crosswalking this code to period. In the case of CPT codes 27197 Response: We appreciate the support CPT code 93452 (Left heart and 27198, we continue to believe that from the commenters. catheterization including the emergent nature inherent with the After consideration of comments intraprocedural injection(s) for left injuries considered typical would mean received, we are finalizing our proposed ventriculography, imaging supervision that other physicians would typically valuation of the Repair Flexor Tendon and interpretation, when performed) perform follow-up care. For detailed codes. which has an identical intraservice time guidance on billing global surgical (8) Closed Treatment of Pelvic Ring and similar total time, after removing procedures, we direct readers to the Fracture (CPT Codes 27197 and 27198) the work associated with post-operative Medicare Claims Processing Manual, visits from CPT code 27198. We Pub. 100–04; billing requirements and For CY 2017, the CPT Editorial Panel proposed a work RVU of 4.75 for CPT adjudication of claims requirements for deleted CPT codes 27193 and 27194 and code 27198. global surgeries are under chapter 12, replaced them with new CPT codes Comment: Some commenters stated sections 40.2 and 40.4. We also note that 27197 and 27198. The RUC that the new coding for these services if this procedure is billed concurrently recommended a work RVU of 5.50 for was designed, in part, to address the with another procedure that is valued CPT code 27193, and a work RVU of appropriateness of a 90-day global with a 10-day or 90-day global period, 9.00 for CPT code 27198. We proposed period by differentiating between higher that the follow up visits associated with to change the global period for these energy and lower energy fractures. the latter procedure would occur as part services from 90 days to 0 days because According to these commenters, the of that package, while follow-up visits these codes typically represent emergent CPT Editorial Panel redefined these for these two codes would be reported procedures with which injuries beyond codes as treating injuries from higher using E/M coding. pelvic ring fractures are likely to occur; energy and more unstable posterior Comment: A commenter states that, we believe it is typical that multiple pelvic ring injuries, and added a for procedures valued as part of a 90- practitioners would be involved in parenthetical directing physicians to use day global period, the physician who is providing post-operative care and it is E/M billing for closed treatment of performing the primary portion of the likely that a practitioner furnishing a isolated lower energy fractures. These treatment is obligated to follow the different procedure is more likely to be commenters say that the new coding patient throughout the entire global providing the majority of post-operative clarifies when to use E/M coding for period and furnish follow-up care. care. If other practitioners are typically these services and when to bill these Response: We understand the furnishing care in the post-surgery two codes. They state that these codes commenter’s perspective that the period, we believe that the six post- should thus remain valued with 90-day treating physician is obligated to service visits included in CPT code global periods while less complicated provide follow-up care within the global 27197, and the seven post-service visits fractures will be billed with E/M coding. period; however, we do not believe that included in CPT code 27198, would Response: We took into consideration this necessitates the valuation of every likely not occur. This is similar to our many factors when determining the surgical procedure with a 10-day or 90- CY 2016 review and valuation of CPT appropriate global period of this service. day global period. While the treating codes 21811 (Open treatment of rib While we understand that the new physician would ideally provide follow- fracture(s) with internal fixation, coding was partly designed to address up care for these codes were they to be includes thoracoscopic visualization the appropriateness of a 90-day global assigned 90-day global periods, we when performed, unilateral; 1–3 ribs), period, we continue to believe that a 0- continue to believe that this would be 21812 (Open treatment of rib fracture(s) day, rather than a 90-day, global period an atypical situation for these types of with internal fixation, includes is more appropriate for this code, since treatments and for these types of thoracoscopic visualization when we believe that the patient would likely injuries. We note that the assignment of performed, unilateral; 4–6 ribs), and already be receiving post-operative care a global period occurs in the process of 21813 (Open treatment of rib fracture(s) because of other injuries. We also evaluation of codes and we take into with internal fixation, includes believe that the practitioner who consideration factors specific to each thoracoscopic visualization when performs the original procedure may not procedure. There may be many performed, unilateral; 7 or more ribs). In typically be performing the follow-up instances when codes with similar our valuation of those codes, we care, and shifting to a 0-day global procedures have different global determined that a 0-day, rather than a period will allow the appropriate periods. We are finalizing as proposed 90-day global period was preferable, in practitioner to report the follow up care, the work RVUs of 1.53 for CPT code part because those codes describe rib when appropriate. 27197 and 4.75 for CPT code 27198, as fractures that would typically occur Comment: A commenter stated that well as an assignment of 0-day global along with other injuries, and the assigning a 0-day global period to this periods. patient would likely already be code will cause these codes to be receiving post-operative care because of different from all other closed fracture (9) Bunionectomy (CPT Codes 28289, the other injuries. We believe that the codes, which the commenter believes 28291, 28292, 28295, 28296, 28297, same rationale applies here. To establish will lead to confusion for physicians 28298, and 28299) a work RVU for CPT code 27197, we and rank order anomalies. The RUC identified CPT code 28293 proposed crosswalking this code to CPT Response: The commenter did not as a 90-day global service with more code 65800 (Paracentesis of anterior present sufficient information to explain than 6 office visits and CPT codes chamber of eye (separate procedure); why the variation in global periods for 28290–28299 as part of the family of with removal of aqueous), due to its these kinds of services would uniquely services. In October 2015, the CPT identical intraservice time and similar cause rank order anomalies. We agree Editorial Panel created two new CPT total time, after removing the work that it is preferable that codes for similar codes (28291, 28295), deleted CPT associated with postoperative visits, and procedures have similar global periods; codes 28290, 28293, and 28294 and its similar level of intensity. Therefore, however, other factors specific to each revised CPT codes 28289, 28292, 28296,

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28297, 28298 and 28299 based on the 65780. The RUC stated it compared the proposed crosswalk from CPT code rationale that more accurate family and relative ranking and believed 65855. The RUC stated that given the descriptions of the services needed to be CPT code 28291 was more complex and emergent nature of the services reported developed. intense than CPT code 28298. The with CPT code 31500, there are few For CPT codes 28289, 28292, 28296, relative difference in work and relevant physician work and time-based 28297, 28298, and 28299, the RUC complexity was reviewed and correctly comparisons within the resource-based recommended and we proposed work ranked by the survey respondents at the relative value scale (RBRVS). RVUs of 6.90, 7.44, 8.25, 9.29, 7.75, and 25th percentile, which corresponds with Response: We appreciate commenters’ 9.29 respectively. For CPT code 28291, the RUC-recommended value. feedback on our proposal. As pointed the RUC recommended a work RVU of One commenter stated that CPT code out by the commenters, the survey data 8.01 based on the 25th percentile of the 28293 was deleted and a new CPT code shows increased intraservice and total survey. We believed the was established because the two times for these services. We agree with recommendation for this service procedures were no longer synonymous. commenters that due to the emergent overestimates the overall work involved Also, the slight decrease in the nature of these services, there are few in performing this procedure given the intraoperative intensity with the new relevant physician work and time-based decrease in intraservice time, total time, value is barely measurable, and comparisons for this service. Therefore, and post-operative visits when therefore, the commenter does not agree due to the emergent nature of these compared to deleted predecessor CPT with CMS that a work RVU of 7.81 is a services and service time increases, for code 28293. Due to similarity in more accurate valuation. CY 2017, we are finalizing a work RVU intraservice and total times, we believed One commenter stated that CPT code of 3.00 for CPT code 31500. a direct crosswalk of the work RVUs for 28295 is more intense than CPT code (11) Flexible Laryngoscopy (CPT Codes CPT code 65780 (Ocular surface 28296 because CPT code 28295 requires 31572, 31573, 31574, 31575, 31576, reconstruction; amniotic membrane separate areas of dissection. With CPT 31577, 31578, and 31579) transplantation, multiple layers) to CPT code 28296, the osteotomy and soft code 28291 more accurately reflects the tissue procedure are performed at the After we identified CPT codes 31575 time and intensity of furnishing the same anatomic location. The commenter and 31579 as potentially misvalued (80 service. Therefore, for CY 2017, we stated this nuance in complexity is the FR 70912–70914), the RUC referred the proposed a work RVU of 7.81 for CPT rationale for separate codes and is entire flexible laryngoscopy family of code 28291. similar to the rationale for separate codes back to the CPT Editorial Panel For CPT code 28295, the RUC cervical versus lumbar spine codes or for revision and the addition of several recommended a work RVU of 8.57 based artery versus vein codes for vascular codes representing new technology on the 25th percentile of the survey. We work. within this family of services. At the believed the recommendation for this Response: We appreciate additional May 2015 CPT meeting, the CPT service overestimates the work involved information offered by the commenters. Editorial Panel added three new codes in performing this procedure given the After consideration of comments to describe laryngoscopy with ablation similarity in the intensity of the services received, we agreed with the additional or destruction of lesion and therapeutic and identical intraservice and total information provided by commenters injection. Based on the survey results, times as CPT code 28296. Therefore, we and are finalizing the RUC-recommend the time resources involved in proposed a direct RVU crosswalk from work RVUs of 6.90, 8.01, 7.44, 8.57, furnishing the procedures described by CPT code 28296 to CPT code 28295. For 8.25, 9.29, 7.75 and 9.29 for CPT codes this code family experienced a CY 2017, we proposed a work RVU of 28289, 28291, 28292, 28295, 28296, significant reduction in the intraservice 8.25 for CPT code 28295. 28297, 28298 and 28299; respectively. period, yet the recommended work Comments: A few commenters, RVUs were not similarly reduced. including the RUC, objected to the (10) Endotracheal Intubation (CPT Code Therefore, in reviewing the proposed work RVUs for CPT codes 31500) recommended values for this family of 28291 and 28295. Commenters noted In the CY 2016 PFS final rule with codes we looked for a rationale for that deleted CPT code 28293 was comment period (80 FR 70914), we increased intensity and absent such marked by the RUC as ‘‘not to use for identified CPT code 31500 as rationale, proposed to adjust the validation of physician work’’. The RUC potentially misvalued. The specialty recommend work RVUs to account for noted the previous time was based on societies surveyed this code, and after significant changes in time. Harvard time and when reviewed in reviewing the survey responses (which For CPT code 31575, we disagreed 1995, the RUC maintained the physician included increases in time) the RUC with the RUC-recommended work RVU work and Harvard time because there recommended a work RVU of 3.00 for of 1.00, and we instead proposed a work was no compelling evidence to revise CPT code 31500. After reviewing the RVU of 0.94. We looked at the total time the value at that time. RUC’s recommendation, we proposed a ratio for CPT code 31575, which is The RUC acknowledged that the work RVU of 2.66, based on a direct decreasing from 28 minutes to 24 deleted CPT code 28293 had 30 minutes crosswalk to CPT code 65855 minutes, and applied this ratio of 0.86 more intra-service time and a higher (Trabeculoplasty by laser surgery), times the current work RVU of 1.10 to work RVU of 11.48 compared to the which has similar intensity and service derive our proposed work RVU of 0.94. recommended work RVU of 8.01 for times. We supported this value for CPT code CPT code 28291. However, the RUC Comment: Commenters requested that 31575 through a crosswalk to CPT code stated the differences in the physician CMS finalize the RUC-recommended 64405 (Injection, anesthetic agent; work, time, intensity and the actual new work RVU of 3.00 instead of CMS’ greater occipital nerve), which shares 5 service as described in CPT code 28291 proposed 2.66 work RVUs. The RUC minutes of intraservice time and also were appropriately accounted for in its stated that the surveyed median has a work RVU of 0.94. recommendation. intraservice time is 10 minutes, We agreed with the RUC that CPT The RUC also stated disagreement representing a doubling of the current code 31575 serves as the base code for with the proposed crosswalk of work intraservice time of 5 minutes. the rest of the Flexible Laryngoscopy RVUs from CPT code 28291 to CPT code Commenters also disagreed with CMS’ family. As a result, we proposed to

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maintain the same RUC-recommended related to the use of scopes. Since we proposed to use the same existing increments for the rest of the codes in believe that the prices in vendor quotes ‘‘video system, endoscopy’’ equipment this family, measuring the increments would typically be equal to or higher (ES031) for the remaining codes in the from CPT code 31575’s refined work than prices actually paid by family that included RUC RVU of 0.94 instead of the RUC- practitioners, we are updating the prices recommendations for new equipment recommended work RVU of 1.00. This in our direct PE database to reflect this items named ‘‘Video-flexible channeled meant that each of the work RVUs for new information. As part of this laryngoscope system’’ and ‘‘Video- the codes in the rest of the family process, we proposed to increase the flexible laryngoscope stroboscopy decreased by 0.06 when compared to price of the ‘‘light source, xenon’’ system.’’ For CPT codes 31576, 31577, the RUC-recommended value. We (EQ167) from $6,723.33 to $7,000 to 31578, 31572, and 31573, we proposed therefore proposed a work RVU of 1.89 reflect current pricing information. We to replace the Video-flexible channeled for CPT code 31576, a work RVU of 2.19 also proposed to adjust the price of the laryngoscope system with the existing for CPT code 31577, a work RVU of 2.43 ‘‘fiberscope, flexible, endoscopy video system (ES031) along for CPT code 31578, a work RVU of 3.01 rhinolaryngoscopy’’ (ES020) from with a channeled flexible video for CPT code 31572, a work RVU of 2.43 $6,301.93 to $4,250.00. rhinolaryngoscope (ES064). For CPT for CPT code 31573, a work RVU of 2.43 In accordance with the wider code 31579, we proposed to rename the for CPT code 31574, and a work RVU of proposal that we made involving the use RUC-recommended ‘‘Video-flexible 1.88 for CPT code 31579. of scope equipment, we proposed to laryngoscope stroboscopy system’’ to Regarding the direct PE inputs, we separate the scopes used in these the shortened ‘‘stroboscopy system’’ proposed to use refined clinical labor procedures from the scope video (ES065) and assign it a price of time for ‘‘Obtain vital signs’’ for CPT systems. In the course of researching $19,100.00. This reflected the price of codes 31577 and 31579 from 3 minutes different kinds of scopes, we obtained the StrobeLED Stroboscopy system to 2 minutes. We believe that this extra vendor pricing for two different types of included on the submitted invoice. We clinical labor time is duplicative, as scopes used in these procedures. We proposed to treat the stroboscopy these codes are typically performed proposed to price the system as a scope accessory, which was with a same day E/M service. Each ‘‘rhinolaryngoscope, flexible, video, included along with the ‘‘video system, procedure is only allotted a maximum non-channeled’’ (ES063) at $8,000 and endoscopy’’ equipment (ES031) and the of 5 minutes for obtaining vital signs, the ‘‘rhinolaryngoscope, flexible, video, ‘‘rhinolaryngoscope, flexible, video, and since 3 minutes are already channeled’’ (ES064) at $9,000 in non-channeled’’ (ES063) for CPT code included in the E/M code, we proposed accordance with our vendor quotes. We 31579. When the price of the scope, the to reduce the time to 2 minutes for these proposed to use the non-channeled scope video system, and the stroboscopy services. Similarly, we proposed to scope for CPT codes 31575, 31579, and system were summed together, the total remove the 3 minutes of clinical labor 31574 and the channeled scope for CPT proposed equipment price was time for ‘‘Clean room/equipment by codes 31576, 31577, 31578, 31572, and $42,145.00. physician staff’’ from CPT codes 31575, 31573 in accordance with the RUC- We proposed to refine the 31577, and 31579. These procedures are recommended video systems that recommended equipment times for typically reported with a same day E/M stipulated channeled versus non- several equipment items to conform to service, making the clinical labor channeled scope procedures. changes in clinical labor time. These minutes for cleaning the room in these We believe that the ‘‘Video-flexible are: The fiberoptic headlight (EQ170), procedure codes duplicative of the time laryngoscope system’’ listed in the the suction and pressure cabinet already included in the E/M codes. recommendations is not a new form of (EQ234), the reclining exam chair with For CPT code 31572, we proposed to equipment, but rather constitutes a headrest (EF008), and the basic remove the ‘‘laser tip, diffuser fiber’’ version of the existing ‘‘video system, instrument pack (EQ137). We proposed supply (SF030) and replace it with the endoscopy’’ equipment (ES031). We did to use the standard equipment time ‘‘laser tip, bare (single use)’’ supply not add a new equipment item to our formula for scope accessories for the (SF029) already present in our direct PE direct PE database; instead, we endoscopy video system (ES031) and database. We believe that the invoice for proposed to use the submitted invoices the stroboscopy scope accessory system SF030 submitted with the RUC to update the price of the ES031 (ES065). We also proposed to refine the recommendation is not current enough endoscopy video system. As the equipment time for the channeled and to establish a new price for this supply; equipment code for ES031 indicates, we non-channeled flexible video as a result, we substituted the SF029 proposed to define the endoscopy video rhinolaryngoscopes to use the standard supply for this input. We welcomed the system as containing a processor, digital equipment time formula for scopes. For submission of new invoices to capture, monitor, printer, and cart. We this latter pair of two new equipment accurately price the diffuser fiber with proposed to price ES031 at $15,045.00; items, this proposal resulted in small laser tip. this reflected a price of $2,000.00 for the increases to their respective equipment We also proposed to make significant monitor, $9,000.00 for the processor, times. changes to the prices of several of the $1,750.00 for the cart, and $2,295.00 for The following is a summary of the supplies and equipment related to the printer. These prices were obtained comments we received regarding our Flexible Laryngoscopy, as well as to the from our vendor invoice, with the proposed valuation of the Flexible prices of scopes more broadly. We exception of the printer, which is a Laryngoscopy codes: proposed to set the price of the crosswalk to the ‘‘video printer, color Comment: Several commenters disposable biopsy forceps supply (Sony medical grade)’’ equipment disagreed with the proposed work RVU (SD318) at $26.84, based on the (ED036). for CPT code 31575. Commenters stated submission of an invoice with a price of We did not agree that there is a need that the use of a work/time ratio was $536.81 for a unit size of 20. In our for multiple different video systems for inconsistent with the methodology of search for additional information this collection of Flexible Laryngoscopy magnitude estimation, and that reducing regarding scope inputs, we obtained a codes based on our understanding of the work RVUs by mathematical formula quote from a vendor listing the current clinical differences among the codes. In can arbitrarily manipulate intensities price for several equipment items keeping with this understanding, we without allowing input from survey

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recommendations provided by experts that the increment between the codes rule (II.A), we have concerns that the who perform the service. Commenters should be maintained after adjusting the pricing for the laser tip, diffuser fiber indicated their disapproval for a reverse work RVU for the base code (CPT code supply has become outdated, and we are building block methodology that 31575) to account for its significant requesting the submission of additional assumes that if times for individual decrease in time. As we detailed in our current pricing information. We are services change, work values must also discussion of code valuation maintaining the current pricing for this change. methodologies earlier in this final rule, supply at $850 pending the submission Response: We continue to believe that we use a variety of different methods, of additional data. the use of these methodologies, such as survey data, building blocks, We note as well that there were many including the use of time ratios, is an crosswalks to key reference or similar comments addressing our proposal to appropriate process for code valuation codes, time ratios, and increments reclassify scope equipment, as well as when recommended work RVUs do not between codes within the same family. the proper pricing of the scope appear to account for significant In our review of RUC-recommended equipment utilized in this family of changes in time. As we stated earlier in values, we have observed that the RUC codes. These comments are summarized our discussion on this topic in this final also uses a variety of methodologies to with responses in the PE section of this rule, we use time ratios to identify develop work RVUs for individual final rule (II.A). potential work RVUs and consider these codes, and subsequently validates the After consideration of comments work RVUs as potential options relative results of these approaches through received, we are finalizing the work to the values developed through other magnitude estimation or crosswalk to RVUs of the codes in the Flexible methodologies for code valuation. We established values for other codes. We Laryngoscopy family at the proposed continue to believe that the decrease in continue to believe that the use of an values. We are also finalizing the total time for CPT code 31575 from 28 incremental methodology is the most proposed direct PE inputs, with the minutes to 24 minutes was not accurate way to value this particular exception of the refinement to the accounted for in the recommended work code family because it maintains the ‘‘Clean room/equipment by physician RVU, and as a result we proposed a appropriate relativity among the staff’’ clinical labor detailed above. work RVU of 0.94, supported by a Flexible Laryngoscopy codes. crosswalk to CPT code 64405. We Comment: One commenter disagreed (12) Laryngoplasty (CPT Codes 31580, continue to believe that this valuation with our refinement to remove the 31584, 31587, 31551–31554, 31591, and for CPT code 31575 more accurately clinical labor time for ‘‘Clean room/ 31592) captures the reduction in physician equipment by physician staff’’ from the CPT code 31588 (Laryngoplasty, not work caused by the decrease in the time three codes in this family performed otherwise specified (e.g., for burns, required to perform the procedure, with a same day E/M service. The reconstruction after partial noting again that the statute specifically commenter stated that the clinical staff laryngectomy)) was identified as defines the work component as the have to clean the equipment for potentially misvalued based on the resources in time and intensity required procedure not used during the E/M RUC’s 90-Day Global Post-Operative in furnishing the service. We believe service. According to the commenter, that our crosswalk to CPT code 64405, they clean that equipment separately Visits screen. When this code family which has very similar time and and are assisting the physician during was reviewed by the RUC, it was intensity values to CPT code 31575 at the entire procedure. determined that some codes in the the same work RVU of 0.94, supports Response: In response to the family required revision to reflect the our valuation for this service. commenter, we investigated this issue typical patient before a survey could be Comment: Several commenters and determined that in the past we have conducted and the code family was objected to the application of the work sometimes provided 1 minute of clinical referred to the CPT Editorial Panel for RVU increment to the rest of the codes labor time for cleaning additional revision. At its October 2015 meeting, in this family, measuring the increments equipment beyond what would be the CPT Editorial Panel approved the from CPT code 31575’s refined work cleaned during the E/M visit. As a creation of six new codes, revision of RVU of 0.94 instead of the RUC- result, we are restoring 1 minute of three codes, and deletion of three codes. recommended work RVU of 1.00. clinical labor time for ‘‘Clean room/ For CPT codes 31580, 31587, 31551, Commenters stated that these codes equipment by physician staff’’ for CPT 31552, 31553, 31554, and 31592, CMS were reviewed individually, not codes 31575, 31577, and 31579. proposed the RUC-recommended work incrementally, and the use of an Comment: One commenter stated that RVUs. increment to reduce the work RVU of there was a lack of clarity regarding the For CPT code 31584, the RUC each code in the family by 0.06 was removal of the laser tip, diffuser fiber recommended a work RVU of 20.00. We inappropriate. Commenters disagreed supply (SF030) from CPT code 31572. believed that the 25th percentile of the with the notion that when a base code’s The commenter stated that the survey, which is a work RVU of 17.58, value is modified or reduced all other commenter supplied an invoice for the better represents the time and intensity codes in the family should be reduced fibers, believed the invoice price was involved with furnishing this service accordingly. accurate, and believed the invoice based on a comparison with and Response: We review codes should be utilized to set the price for assessment of the overall intensity of individually for valuation. When we this item. other codes with similar instraservice apply an increment from a base code to Response: We continue to believe that and total time. This value is also the rest of a code family, we do so only the invoice for SF030 submitted with supported by a crosswalk code of CPT after reviewing each code individually the RUC recommendation, which dates code 42844 (Radical resection of tonsil, and determining that the RUC- from 2009, is not current enough to tonsillar pillars, and/or retromolar recommended relativity between the establish a new price for this supply. trigone; closure with local flap (e.g., codes in the family is correct. For this We are continuing to maintain the laser tongue, buccal)), which has identical particular family of codes, we stated our tip, bare (single use) supply (SF029) in intraservice time and identical total belief that the relativity between the its place for CPT code 31572. As we time. Therefore, we proposed a work codes in the family was accurate, and discuss in the PE section of this final RVU of 17.58 for CPT code 31584.

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Comment: Several commenters 13.29, and CPT code 49654 Response: We appreciate the requested that we provide an (Laparoscopy, surgical, repair, commenters’ interests in making certain explanation for our proposed work RVU incisional hernia (includes mesh that there is appropriate opportunity for of 17.58 for the revised CPT code 31584 insertion, when performed); reducible), stakeholders to provide feedback and instead of the RUC-recommended work which has a work RVU of 13.76; both of recommendations on the reclassification RVU of 20.00. They stated that the these codes have identical intraservice and pricing of scopes. Because these modified code now represents the time and similar total time. Therefore, codes are currently under review, combination of two previously separate we proposed a work RVU of 13.56 for however, we believe that they should be CPT codes (the existing CPT code 31584 CPT code 31591. valued according to a scheme that combined with CPT code 31600) and Comment: Several commenters accurately describes the scope that the work RVU should better reflect disagreed with our proposed work RVU equipment typically used in the the sum of the total time for these of 13.56 for CPT code 31591, stating that services. We continue to believe that our combined procedures. Commenters the RUC-recommended work RVU of proposed classification system for further noted that the proposed work 15.60 better reflects the work required to scopes is the more proper methodology RVU of 17.58 is lower, even, than the perform the procedure. to use for valuation of these codes for existing work RVU for CPT code 31584. Response: In developing our proposed the CY 2017. Please refer to II.A of the A commenter requested that CMS valuation, we looked at other 90-day final rule for additional discussion on consider two additional codes for global codes with identical intraservice the new pricing process. comparison: CPT code 37660 and CPT time and similar total time (between 275 (13) Closure of Left Atrial Appendage code 43280. and 335), and we note that the median Response: We take multiple factors work RVU of the resulting values With Endocardial Implant (CPT Code into account when valuing a service that (reflecting 33 codes) is 13.76. We chose 33340) replaces two previously separate codes. the 25th percentile of the survey The CPT Editorial Panel deleted We consider the efficiencies of because of its closeness to the median category III CPT code 0281T combining two services, as reflected in work RVU of comparable services. We (Percutaneous transcatheter closure of the adjustment upwards of the intra- recognize that the RUC’s crosswalk to the left atrial appendage with implant, service and total time for this code. We CPT code 58544, with a work RVU of including fluoroscopy, transseptal also review the code description and 15.60, has a lower total time than the puncture, catheter placement(s), left identify a value that is consistent with codes we used as comparisons, but we atrial angiography, left atrial appendage other, similar, 90-day global codes. Our note that this code has very low angiography, radiological supervision valuation is above the median work utilization, with 103 procedures billed and interpretation) and created new RVU for a group of 28 codes with in 2015. We continue to believe that two CPT code 33340 to describe similar intraservice and total time. codes bracketing the 25th percentile of percutaneous transcatheter closure of Commenters have not provided any the work RVU for CPT code 31591 (CPT the left atrial appendage with implant. additional information that would codes 36819 and 49654), as noted in the The RUC recommended a work RVU of suggest this code should be valued CY2017 PFS proposed rule, provide a 14.00. We proposed a work RVU of differently from other 90-day global better reference for valuing the new 13.00 for CPT code 33340, which is the codes with similar time and intensity. code, and that a work RVU of 13.56 minimum survey result. Based on our We reviewed the two additional codes adequately represents the time and clinical judgment and that the key that commenters recommended as intensity involved with furnishing the reference codes discussed in the RUC comparisons. We note that CPT code service. Therefore, we are finalizing our recommendations have higher 43280 (work RVU of 18.1) was most proposed work RVU of 13.56 for CPT intraservice and total service times than recently valued in 1997 and that for code 31591. the median survey results for CPT code low-volume code CPT code 37660, Additionally, the RUC forwarded 33340, we stated in the CY 2017 physician intensity is considerably invoices provided by a medical proposed rule that we believe a work higher than that for CPT code 31584, specialty society for the video-flexible RVU of 13.00 would more accurately suggesting a poor reference for laryngoscope system used in these represent the work value for this comparing the work involved in services. We discussed our proposed service. furnishing the service. For these changes to the items included in Comment: We received several reasons, we do not believe this code is equipment item ES031 (video system, comments, including from the RUC. an appropriate comparison for CPT code endoscopy) in the CY 2017 proposed Commenters noted inaccuracies in CMS’ 31584 and we are finalizing our work rule (81 FR 46247). Consistent with description of the RUC RVU of 17.58 for CPT code 31584. those proposed changes, we proposed to recommendations including For CPT code 31591, the RUC add a Nasolaryngoscope, non- descriptions of the relationship between recommended a work RVU of 15.60. We channeled, to the list of equipment the RUC-recommended work RVU, believed that the 25th percentile of the items used for CPT codes 31580, 31584, survey results, and service times for the survey, which is a work RVU of 13.56, 31587, 31551–31554, 31591, and 31592, two key reference codes. Commenters better represents the time and intensity along with the modified equipment item requested that CMS finalize the RUC- involved with furnishing this service ES031. recommended work RVU of 14.00. based on a comparison of the overall Comment: We received several Response: We appreciate the intensity of other codes with similar comments, including from the RUC, commenters’ feedback and acknowledge instraservice and total time. The 25th about our proposal to implement a that we inadvertently mischaracterized percentile of the survey is additionally separate pricing approach for equipment the RUC’s recommendations related to bracketed by two crosswalk codes that inputs for this family of codes. this service. We agree that the survey we estimate have slightly lower and Commenters requested a delay in results showed a 25th percentile survey slighter higher overall intensities, CPT implementing our approach until the result of 19.88 and that during the RUC code 36819 (Arteriovenous anastomosis, RUC convened a PE subcommittee and meeting, this code was referred to the open; by upper arm basilic vein provided CMS with specific facilitation committee whereby the RUC transposition), which has a work RVU of recommendations for these codes. identified two comparable codes with

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14.00 work RVUs, which the RUC intraservice times and decreased total whereas that same ratio for the key factored into its analysis and times compared to CPT code 33400. reference code used by the RUC is recommended valuation for this service. Therefore, for CY 2017, we are finalizing 0.0883, and that the divergent ratios After consideration of the comments, we a work RVU of 35.00 for CPT code between the two services are not are finalizing the RUC-recommended 33390 and a work RVU of 41.50 for CPT comparable. work RVU of 14.00 for CPT code 33340. code 33391. Response: The commenters (14) Valvuloplasty (CPT Codes 33390 (15) Mechanochemical Vein Ablation recommended that we accept the RUC- and 33391) (MOCA) (CPT Codes 36473 and 36474) recommended ratio of 36 percent between the RUC-recommended work The CPT Editorial Panel created new At the October 2015 CPT meeting, the RVUs for CPT codes 36473 and 36474. codes to describe valvuloplasty CPT Editorial Panel established two We disagree. The RUC survey reported procedures and deleted existing CPT Category I codes for reporting venous 79 minutes of total time for CPT code code 33400 (Valvuloplasty, aortic valve; mechanochemical ablation, CPT codes 36473 and 30 minutes of total time for open, with cardiopulmonary bypass). 36473 and 36474. We proposed the CPT code 36474, a decrease of greater New CPT code 33390 represents a RUC-recommended work RVU of 3.50 than 50 percent between the base code simple valvuloplasty procedure and for CPT code 36473. For CPT code and the add-on code. As discussed in new CPT code 33391 describes a more 36474, we proposed a work RVU of 1.75 the proposed rule, our proposed work complex valvuloplasty procedure. We and stated that we believed the RUC- RVU of 1.75 for CPT code 36474 is proposed to use the RUC-recommended recommended work RVU of 2.25 does supported by the ratio between work values for CPT code 33390. For CPT not accurately reflect the typical work and time in the key reference service. code 33391, the RUC recommended a involved in furnishing this procedure. The RUC recommendations made work RVU of 44.00, the 25th percentile The specialty society survey showed reference to two identical sets of survey result. The RUC estimated that that this add-on code has half the work services that use differing mechanisms approximately 70 percent of the services of the base code (CPT code 36473). This for ablating the vein (radiofrequency previously reported using CPT code value is supported by the ratio between procedures reported with CPT codes 33400 would be reported using CPT work and time in the key reference 36475 and 36476 (work RVUs of 5.30 code 33391, with 30 percent reported service (CPT code 36476: Endovenous and 2.65); laser procedures reported using new CPT code 33390. Therefore, ablation therapy of incompetent vein, with CPT codes 36478 and 36479 (work the typical service previously reported extremity, inclusive of all imaging RVUs of 5.30 and 2.65)). Both key with CPT code 33400 ought to now be guidance and monitoring, percutaneous, reference code sets have a work RVU reported with CPT code 33391. radiofrequency; second and subsequent ratio of 50 percent (5.30 versus 2.65) Compared to deleted CPT code 33400, veins treated in a single extremity, each between the base codes and the add-on the survey results for CPT code 33391 through separate access sites (List codes. Therefore, for CY 2017, we are showed similar median intraservice separately in addition to code for times and decreased total times. primary procedure)). finalizing a work RVU of 3.50 for CPT Therefore, we proposed a work RVU of The RUC-recommended direct PE code 36473 and a work RVU of 1.75 for 41.50 for CPT code 33391, which is the inputs for CPT codes 36473 and 36474 CPT code 36474. current value of CPT code 33400. Given included inputs for an ultrasound room Comment: Commenters requested that that the typical service should remain (EL015). Based on the clinical nature of CMS restore the direct PE inputs for the consistent between the two codes, we these procedures, we stated in our ultrasound room, which includes the stated that we believe the work RVUs proposal that we do not believe that an PACS workstation. Commenters stated should remain consistent as well. ultrasound room would typically be that the PACS workstation is needed for Comment: Commenters disagreed used to furnish these procedures. We these procedures to store and make with CMS’ proposed valuation of CPT proposed to remove inputs for the images available for future use. code 33391, citing increased intensity ultrasound room and subsequently Response: Commenters suggested that and complexity of the procedures. include a portable ultrasound (EQ250), the ultrasound room was necessary for Commenters noted that more complex power table (EF031), and light (EF014). this procedure since the ultrasound patients are undergoing valvuloplasty The RUC also recommended that the room includes a PACS workstation that (for instance, adult cardiac patients) ultrasound machine be allocated would allow for storage of the images when historically these patients would clinical staff time based on the PACS and subsequent future use. As we have received aortic valve replacements. workstation formula. We stated that we discussed in the proposed rule, during Response: As discussed in the CY did not believe that an ultrasound the typical procedure, the images would 2017 proposed rule, the deleted CPT machine would be used like a PACS be used in real time rather than being code 33400 is being replaced with two workstation, as images are generated stored for subsequent interpretation. CPT codes that identify simple and and reviewed in real time. Therefore, we Further, the ultrasound room would not complex procedures. The RUC’s proposed to remove all direct PE inputs be typically used during these utilization crosswalk suggests that associated with the PACS workstation. procedures. Our proposal included a approximately 70 percent of the services Comment: We received several portable ultrasound that allows for use that would previously have been comments, including from the RUC. of the images during the course of the reported using the combined code (CPT Commenters disagreed with CMS’ procedure. code 33400) would now be reported proposed work RVU of 1.75 for CPT Comment: One commenter requested with CPT code 33391, the complex code 36474 and requested that CMS that CMS include an additional direct procedure. Based on the RUC’s finalize the RUC’s recommendation of PE input for a ClariVein catheter for utilization crosswalk, the complex 2.25 work RVUs. The RUC disagreed both CPT codes 36473 and 36474, and procedure would be the typical with CMS’ rationale for the proposed included invoices related to this item. procedure reported under the combined work RVU for CPT code 36474. The The commenter suggested that an code (CPT code 33400). The survey data RUC stated that the ratio between CMS’ additional catheter is necessary to for the complex procedure (CPT code proposed physician time and physician prevent contamination during treatment 33391) showed similar median work for the survey code is 0.058, of subsequent vessels if the catheter

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used in an initial vessel were reused in venous outflow including the inferior or CPT code 36901. As a result, we a subsequent vessel. superior vena cava), radiological proposed to crosswalk CPT code 36901 Response: The invoice data submitted supervision and interpretation), 75962 to CPT code 44388 (Colonoscopy by the commenter appears to be (Transluminal balloon angioplasty, through stoma; diagnostic). CPT code applicable to the ClariVein catheters in peripheral artery other than renal, or 44388 has a work RVU of 2.82, and we some instances and in others to the other visceral artery, iliac or lower believe it is a more accurate crosswalk ClariVein kits. Our review of the extremity, radiological supervision and for valuation due to its similar overall ClariVein kits indicated that the interpretation), and 75968 intensity and shared intraservice time of ClariVein catheters are part of the (Transluminal balloon angioplasty, each 25 minutes with 36901 and similar total ClariVein kits. Because we lack clear additional visceral artery, radiological time of 65 minutes. product data regarding the cost of the supervision and interpretation). These We proposed a work RVU of 4.24 for ClariVein kits versus the ClariVein codes are frequently reported together CPT code 36902 instead of the RUC- catheters and whether the catheters are for both dialysis circuit services and recommended work RVU of 4.83. The included in the price of the kits, for CY transluminal angioplasty services. At RUC-recommended work RVU is based 2017, we are finalizing our proposed the October 2015 CPT Editorial Panel upon a direct crosswalk to CPT code direct PE inputs for the ClariVein kits meeting, the panel approved the 43253 (Esophagogastroduodenoscopy, for CPT codes 36473 and 36474 without creation of nine new codes and deletion flexible, transoral), which shares the modification. We welcome additional of four existing codes used to describe same 40 minutes of intraservice time feedback from stakeholders regarding bundled dialysis circuit intervention with CPT code 36902. However, CPT the product data and costs for the services, and the creation of four new code 43253 has significantly longer total ClariVein catheters and ClariVein kits codes and deletion of 13 existing codes time than CPT code 36902, 104 minutes for consideration in future rulemaking. used to describe bundled percutaneous against 86 minutes, which we believe (16) Dialysis Circuit (CPT Codes 36901, transluminal angioplasty services (see reduces its utility for comparison. We 36902, 36903, 36904, 36905, 36906, discussion of the latter code family in instead proposed to crosswalk the work 36907, 36908, 36909) the next section). The Dialysis Circuit RVU for CPT code 36902 from CPT code family of codes overlaps with the Open In January 2015, a CPT/RUC 44408 (Colonoscopy through stoma), and Percutaneous Transluminal workgroup identified the following CPT which has a work RVU of 4.24. In Angioplasty family of codes (CPT codes codes as being frequently reported addition to our assessment that the two 37246–37249), as they are both being together in various combinations: 35475 codes share similar intensities, CPT constructed from the same set of (Transluminal balloon angioplasty, code 44408 also shares 40 minutes of frequently reported together codes. We percutaneous; brachiocephalic trunk or intraservice time with CPT code 36902 branches, each vessel), 35476 reviewed these two families of codes but has only 95 minutes of total time (Transluminal balloon angioplasty, concurrently to maintain relativity and matches the duration of the percutaneous; venous), 36147 between these clinically similar procedure under review more closely (Introduction of needle and/or catheter, procedures based upon the same than the RUC-recommended crosswalk arteriovenous shunt created for dialysis collection of deleted codes. to CPT code 43253. We also note that (graft/fistula); initial access with For CPT code 36901, we proposed a the RUC-recommended work increment complete radiological evaluation of work RVU of 2.82 instead of the RUC- between CPT codes 36901 and 36902 dialysis access, including fluoroscopy, recommended work RVU of 3.36. When was 1.47, and by proposing a work RVU image documentation and report), 36148 we compared CPT code 36901 against of 4.24 for CPT code 36902, we would (Introduction of needle and/or catheter, other codes in the RUC database, we maintain a very similar increment of arteriovenous shunt created for dialysis found that the RUC-recommended work 1.42. As a result, we proposed a work (graft/fistula); additional access for RVU of 3.36 would be the highest value RVU of 4.24 for CPT code 36902, based therapeutic intervention), 37236 in the database among the 32 0-day on this direct crosswalk to CPT code (Transcatheter placement of an global codes with 25 minutes of 44408. For CPT code 36903, we intravascular stent(s) (except lower intraservice time. Generally speaking, proposed a work RVU of 5.85 instead of extremity artery(s) for occlusive disease, we are particularly skeptical of RUC- the RUC-recommended work RVU of cervical carotid, extracranial vertebral or recommended values for newly 6.39. The RUC-recommended value is intrathoracic carotid, intracranial, or ‘‘bundled’’ codes that appear not to based on a direct crosswalk to CPT code coronary), open or percutaneous, recognize the full resource overlap 52282 (Cystourethroscopy, with including radiological supervision and between predecessor codes. Since the insertion of permanent urethral stent). interpretation and including all recommended values would establish a Like the previous pair of RUC- angioplasty within the same vessel, new highest value when compared to recommended crosswalk codes, CPT when performed; initial artery), 37238 other services with similar time, we code 52282 shares the same intraservice (Transcatheter placement of an believed it likely that the recommended time of 50 minutes with CPT code intravascular stent(s), open or value for the new code does not reflect 36903, but has substantially longer total percutaneous, including radiological the efficiencies in time. Of course, were time (120 minutes against 96 minutes) supervision and interpretation and there compelling evidence for this which we believe limits its utility as a including angioplasty within the same valuation accompanying the crosswalk. We proposed a work RVU of vessel, when performed; initial vein), recommendation, we would consider 5.85 based on maintaining the RUC- 75791 (Angiography, arteriovenous such information. We also noted that recommended work RVU increment of shunt (eg, dialysis patient fistula/graft), the reference code selected by the 3.03 as compared to CPT code 36901 complete evaluation of dialysis access, survey participants, CPT code 36200 (proposed at a work RVU of 2.82), the including fluoroscopy, image (Introduction of catheter, aorta), has a base code for this family of related documentation and report (includes higher intraservice time and total time, procedures. We also point to CPT code injections of contrast and all necessary but a lower work RVU of 3.02 We 44403 (Colonoscopy through stoma; imaging from the arterial anastomosis believe that there are more accurate CPT with endoscopic mucosal resection) as a and adjacent artery through entire codes that can serve as a reference for reference point for this value. CPT code

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44403 has a work RVU of 5.60, but also crosswalks that both share the same 90 For CPT code 36908, we disagree with lower intraservice time (45 minutes as minutes of intraservice time with 36906. the RUC-recommended work RVU of compared to 50 minutes) and total time These are CPT code 31546 4.25, and we instead proposed a work (92 minutes as compared to 96 minutes) (Laryngoscopy, direct, with submucosal RVU of 3.73. We did not consider the in relation to CPT code 36903, removal of non-neoplastic lesion(s) of RUC work value of 4.25 to be accurate suggesting that a work RVU a bit higher vocal cord) at a work RVU of 9.73 and for CPT code 36908, as this was higher than 5.60 would be an accurate CPT code 61623 (Endovascular than our proposed work value for CPT valuation. Therefore, we proposed a temporary balloon arterial occlusion, code 36902 (4.24), and we did not work RVU of 5.85 for CPT code 36903, head or neck) at a work RVU of 9.95. believe that an add-on code should based on an increment of 3.03 from the The final three codes in the Dialysis typically have a higher work value than work RVU of CPT code 36901. Circuit family are all add-on codes, a similar non-add-on code with the We proposed a work RVU of 6.73 which make comparisons difficult to the same intraservice time. We identified instead of the RUC-recommended work global 0-day codes that make up the rest two appropriate crosswalks for valuing RVU of 7.50 for CPT code 36904. Our of the family. We proposed a work RVU CPT code 36908: CPT code 93462 (Left proposed value comes from a direct of 2.48 instead of the RUC- heart catheterization by transseptal crosswalk from CPT code 43264 recommended work RVU of 3.00 for puncture through intact septum or by (Endoscopic retrograde CPT code 36907. Due to the difficulty of transapical puncture) and CPT code cholangiopancreatography), which comparing CPT code 36907 with the 37222 (Revascularization, endovascular, shares the same intraservice time of 60 non-add-on codes in the rest of the open or percutaneous, iliac artery). Both minutes with CPT code 36904 and has Dialysis Circuit family, we looked of these codes share the same a higher total time. We also looked to instead to compare the value to the add- intraservice time as CPT code 36908, the intraservice time ratio between CPT on codes in the Open and Percutaneous and both of them also have the same codes 36901 and 36904; this works out Transluminal Angioplasty family of work RVU of 3.73, which results in to 60 minutes divided by 25 minutes, codes (CPT codes 37246–37249). As we these codes also sharing the same for a ratio of 2.4, and a suggested work stated previously, both of these groups intensity since they are all add-on RVU of 6.77 (derived from 2.4 times of new codes are being constructed from codes. We therefore proposed a work CPT code 36901’s work RVU of 2.82). the same set of frequently reported value of 3.73 for CPT code 36908, based This indicates that our proposed work together codes. We reviewed these two on a direct crosswalk to CPT codes RVU of 6.73 maintains relativity within families of codes together to maintain 93462 and 37222. the Dialysis Circuit family. As a result, Finally, we proposed a work RVU of relativity across the two families, and so we proposed a work RVU of 6.73 for 3.48 for CPT code 36909 instead of the that we could compare codes that CPT code 36904, based on a direct RUC-recommended work RVU of 4.12. shared the same global period. crosswalk to CPT code 43264. The RUC-recommended value comes We proposed a work RVU of 8.46 We proposed the RUC-recommended from a direct crosswalk from CPT code instead of the RUC-recommended work work RVUs for all four codes in the 38746 (Thoracic lymphadenectomy by RVU of 9.00 for CPT code 36905. We Open and Percutaneous Transluminal thoracotomy). We compared the RUC- looked at the intraservice time ratio Angioplasty family of codes. As a result, recommended work RVU for this between CPT codes 36901 and 36905 as we compared CPT code 36907 with the procedure to other add-on codes with 30 one potential method for valuation, RUC-recommended work RVU of 2.97 minutes of intraservice time and found which is a 1:3 ratio (25 minutes against for CPT code 37249, which is also an that the recommended work RVU of 75 minutes) for this case. This means add-on code. These procedures should 4.12 would overestimate the overall that one potential value for CPT code be clinically very similar, since both of intensity of this service relative to those 36905 would be triple the work RVU of them are performing percutaneous with similar times. In reviewing the CPT code 36901, or 2.82 times 3, which transluminal angioplasty on a central range of these codes, we believed that a results in a work RVU of 8.46. We also vein, and both of them are add-on more appropriate crosswalk is to CPT investigated preserving the RUC- procedures. We looked at the code 61797 (Stereotactic radiosurgery recommended work RVU increment intraservice time ratio between these (particle beam, gamma ray, or linear between CPT code 36901 and 36905, two codes, which was a comparison accelerator)) at a work RVU of 3.48. We which was an increase of 5.64. When between 25 minutes for CPT code 36907 believed that this value is more accurate this increment is added to the work against 30 minutes for CPT code 37249. when compared to other add-on RVU of 2.82 for CPT code 36901, it also This produces a ratio of 0.83, and a procedures with 30 minutes of resulted in a work RVU of 8.46 for CPT proposed work RVU of 2.48 for CPT intraservice time across the PFS. As a code 36905. Therefore, we proposed a code 36907 when multiplied with the result, we proposed a work RVU of 3.48 work RVU of 8.46 for CPT code 36905, RUC-recommended work RVU of 2.97 for CPT code 36909 based on a direct based on both the intraservice time ratio for CPT code 37249. We noted as well crosswalk from CPT code 61797. with CPT code 36901 and the RUC- that the intensity was markedly higher We proposed to use the RUC- recommended work increment with the for CPT code 36907 as compared to CPT recommended direct PE inputs for these same code. code 37249 when using the RUC- nine codes with several refinements. We For CPT code 36906, we proposed a recommended work values, which did did not propose to include the work RVU of 9.88 instead of the RUC- not make sense since CPT code 36907 recommended additional preservice recommended work RVU of 10.42. We would typically be a clinically less clinical labor for CPT codes 36904, based the proposed value upon the intense procedure. Using the 36905, and 36906. The preservice work RUC-recommended work RVU intraservice time ratio results in the two description is identical for all six of the increment between CPT codes 36901 codes having exactly the same intensity. global 0-day codes in this family; there and 36906, which is 7.06. When added As a result, we therefore proposed a is no justification given in the RUC to the work RVU of 2.82 for CPT code work RVU of 2.48 for CPT code 36907, recommendations as to why the second 36901, the work RVU for CPT code based on this intraservice time ratio three codes need additional clinical 36906 would be 9.88. We are supporting with the RUC-recommended work RVU labor time beyond the minimal this value through the use of two of CPT code 37249. preservice clinical labor assigned to the

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first three codes. We do not believe that (SG095) from 2 to 1 for CPT codes access to reasonable and necessary the additional staff time would be 36904, 36905, and 36906. This supply physicians’ services. typical. Patient care already would have was not included in any of the deleted We note that a change in overall RVUs been coordinated ahead of time in the base codes out of which the new codes for particular services, regardless of the typical case, and the need for are being constructed, and while we magnitude of the change, may reflect unscheduled dialysis or other unusual agreed that the use of a single improved accuracy. For example, circumstances would be discussed prior hemostatic patch has become common comparing the summed total RVU of to the day of the procedure. We clinical practice, we did not agree that CPT codes 36147, 36148, 36870, and therefore proposed to refine the CPT codes 36904–36906 would 37238 against the total RVU of CPT code preservice clinical labor for CPT codes typically require a second patch. As a 36906 is an accurate method to describe 36904, 36905, and 36906 to match the result, we proposed to refine the SG095 the services taking place under the preservice clinical labor of CPT codes supply quantity from 2 to 1 for CPT coding schema effective for 2016 and 36901, 36902, and 36903. codes 36904–36906, which also matches 2017, respectively. Through the We proposed to refine the L037D the supply quantity for CPT codes bundling of these frequently reported clinical labor for ‘‘Prepare and position 36901–36903. services, it is reasonable to expect that patient/monitor patient/set up IV’’ from Included in the RUC recommendation the new coding system will achieve 5 minutes to 3 minutes for CPT codes for the Dialysis Circuit family of codes savings via elimination of duplicative 36901–36906. The RUC were a series of invoices for a assumption of the resources involved in recommendation included a written ‘‘ChloraPrep applicator (26 ml)’’ supply. furnishing particular servicers. For justification for additional clinical labor We solicited comments regarding example, a practitioner would not be time beyond the standard 2 minutes for whether the Betadine solution has been carrying out the full preservice work this activity, stating that the extra time replaced by a Chloraprep solution in the four separate times for CPT codes is needed to prepare the patient’s arm typical case for these procedures. We 36147, 36148, 36870, and 37238, but for the procedure. We agreed that extra also solicited comments regarding preservice times were assigned to each time may be needed for this activity as whether the ‘‘ChloraPrep applicator (26 of the codes under the old coding. We compared to the default standard of 2 ml)’’ detailed on the submitted invoices believe the new coding assigns a more minutes; however, we proposed to is the same supply as the SH098 accurate preservice time and thus assign 1 extra minute for preparing the ‘‘chlorhexidine 4.0% (Hibiclens)’’ reflects efficiencies in resource costs patient’s arm, resulting in a total of 3 applicator currently in the direct PE that existed regardless of how the minutes for this task. We did not believe database. services were previously reported. that 3 extra minutes would be typically Finally, we also solicited comments Comment: Several commenters needed for arm positioning. about the use of guidewires for these objected to the crosswalk codes used by We proposed to remove the ‘‘kit, for procedures. We requested feedback CMS for proposed work valuation. percutaneous thrombolytic device about which guidewires would be Commenters stated that comparing the (Trerotola)’’ supply (SA015) from CPT typically used for these procedures, and Dialysis Circuit codes to colonoscopy or codes 36904, 36905, and 36906. We which guidewires are no longer endoscopic retrograde believed that this thrombolytic device clinically necessary. cholangiopancreatography (ERCP) codes kit and the ‘‘catheter, thrombectomy- The following is a summary of the was inappropriate, as it undervalued the Fogarty’’ (SD032) provide essentially the comments we received regarding our technical skill and judgment necessary same supply, and the use of only one of proposed valuation of the Dialysis to furnish the services. In other words, them would be typical in these Circuit codes. Due to the large number the crosswalks chosen by CMS were procedures. We believed that each of of comments we received for this code invalid due to the differences in the these supplies can be used individually family, we will first summarize the procedures in question, with the for thrombectomy procedures. We comments related to general code Dialysis Circuit codes being more proposed to remove the SA015 supply valuation, followed by the comments intensive procedures than the CMS and retain the SD032 supply, and we related to specific work RVUs, and crosswalks. solicited additional comment and finally the comments related to direct Response: We disagree with the information regarding the use of these PE inputs. commenters that the choice of crosswalk two supplies. Comment: Several commenters stated codes is inappropriate for work We also proposed to remove the that the cumulative impact of valuation. We believe that, generally recommended supply item ‘‘covered reimbursement reductions for the speaking, codes with similar intensity stent (VIABAHN, Gore)’’ (SD254) and Dialysis Circuit family of codes in and time values are broadly comparable replace it with the ‘‘stent, vascular, physician work and practice expense across the PFS, as the fee schedule is deployment system, Cordis SMART’’ would be quite dramatic. The based upon a relative value system. For (SA103) for CPT codes 36903 and commenters compared the total RVU of the Dialysis Circuit codes in particular, 36906. The Cordis SMART vascular the old codes against the total RVU of we provided a specific rationale for each stent was previously used in the past for the newly created codes and found a crosswalk detailing why we believed it CPT code 37238, which is the deleted decrease of roughly 20–30 percent. to be an appropriate selection. code for transcatheter placement of an Commenters expressed concern that if Regarding the statement from the intravascular stent that CPT codes the proposed rates were to be commenters that colonoscopy codes, 36903 and 36906 are replacing. We did implemented, many outpatient access such as CPT code 44388, are not have a stated rationale as to the need centers that focus on providing care for inappropriate for use as crosswalks in for this supply substitution, and ESRD patients might no longer be able this family of codes, we note that the therefore, we did not believe it would be to operate. RUC-recommended work RVU for CPT appropriate to replace the current items Response: We share the concern of the code 36901 was based upon a direct with a significantly higher-priced item commenters in maintaining access to crosswalk to the work RVU of a without additional information. care for Medicare beneficiaries. We colonoscopy code (CPT code 45378). We We also proposed to refine the believe that improved payment accuracy continue to believe that the crosswalks quantity of the ‘‘Hemostatic patch’’ under the PFS generally facilitates for this family of codes are appropriate

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choices, since they share highly similar recommended values for newly the particular case of the Dialysis intensity and time values with the ‘‘bundled’’ codes that appear not to Circuit family of codes, we do not agree reviewed codes. recognize the full resource overlap with the commenter that the single Comment: Some commenters between predecessor codes. Since the ‘‘vessel’’ classification of these disagreed with the use of time ratios for recommended values would establish a procedures supports a higher intensity work valuation. These commenters new highest value when compared to compared to other related codes. These stated that the use of direct crosswalks other services with similar time, we codes have been defined by CPT in a based only on intraservice time believe it likely that the recommended similar fashion to the lower extremity comparison or ratios of intraservice time value for the new code does not reflect revascularization codes, in which the inappropriately discounted the variation the efficiencies gained through code is only billed a single time in technical skill, judgment, and risk bundling. We believe that these regardless of the number of lesions or inherent to these procedures. comparisons to other codes with similar number of stents placed. Due to the Response: We continue to believe that time values and intensities are an similarity with these existing codes the use of these methodologies, important tool in helping to maintain located elsewhere in the PFS, we do not including the use of time ratios, is an relativity across the fee schedule. believe that it would be appropriate to appropriate process for identifying Comment: A commenter disagreed value the Dialysis Circuit codes potential values for particular codes, with the CMS valuation for these codes differently. especially when the recommended work based on a clinical rationale pertaining Comment: Several commenters RVUs do not appear to account for to how the services are defined. The suggested that there was compelling significant changes in time. As we commenter stated that the dialysis evidence for the higher RUC- stated earlier in our discussion on this access circuit is defined as originating recommended work RVUs because the topic in this final rule, we use time in the artery adjacent to the arterial vignette developed by the CPT Editorial ratios to identify potential work RVUs anastomosis and including all venous Panel does not accurately reflect the and consider these work RVUs as outflow (whether single or multiple typical ESRD patient. Commenters potential options relative to the values veins) to the axillary-subclavian vein stated that the vignette for the Dialysis developed through other methodologies junction. While several different arteries Circuit codes significantly for code valuation. We continue to and veins may be included in this underestimated the age of the typical believe our valuation for the Dialysis definition, from a functional perspective patient, and may have led survey Circuit codes accurately captures the it is a single ‘‘vessel’’. The commenter respondents to report less time. reduction in physician work caused by stated that because of this greater According to commenters, the frail and the efficiencies gained in both time and propensity for multiple lesions in these elderly ESRD patients that constitute the intensity through the bundling together procedures, it is appropriate to define typical patients for these procedures are of frequently reported services. the access vessel as CPT has done and much sicker than the typical patient in Comment: One commenter disagreed allow reporting of only a single other codes on the PFS, and this serves with the use of CMS comparisons angioplasty or stent in that entire to justify valuing these codes at a higher between the RUC-recommended work conduit. However, the commenter intensity. RVUs for the Dialysis Circuit codes and reported that the survey built on the Response: We appreciate the the work RVU for other codes with ‘‘typical patient’’ (51 percent of the submission of additional information similar time values in the rest of the fee cases) was unable to recognize the regarding the patient population for schedule, particularly for CPT code additional work of additional these codes. We recognize that some 36901. The commenter stated that angioplasty or stent for the Dialysis services may require additional work whether or not CPT code 36901 had the Circuit family of codes, even though due to an unusually difficult patient highest work RVU among other 0-day multiple or arterial lesions occur with population. However, we do not agree at global codes with 25 minutes of intra- significant frequency. Because the this time that the Dialysis Circuit family service time was irrelevant. The coding structure of the Dialysis Circuit of codes has a uniquely different patient commenter pointed out that some code family does not include a code for population that justifies an increase in must be the highest value because the ‘‘additional vessels’’, the valuation of valuation over other comparable codes RBRVS represents a range of services of the codes needs to incorporate the on the PFS. We note that for CPT code varying intensity. The commenter stated resource cost of patient cases where 36901, the RUC recommended a work that CMS’ reasoning undervalued the multiple or arterial lesions occur. The RVU of 3.36 based on a direct crosswalk importance of work intensity in favor of commenter contended that this problem to CPT code 45378, a flexible the more easily quantifiable time with the survey methodology affected colonoscopy code. Our proposed work variable, which was clinically the work intensity of these codes, and RVU of 2.82 for the same code was inaccurate and contradictory to the justifies a higher intensity for these based on a direct crosswalk to CPT code principles of the relative value system. procedures. 44388, which is another colonoscopy Response: We disagree with the Response: We share the commenter’s code. The patient population for these commenter about the invalidity of concerns with the survey data collected two crosswalk codes is similar, and both comparing newly created codes to by the RUC. This is why we have long codes share similar time and intensity. existing codes with similar time values employed different approaches to We believe that our crosswalk code is a on the PFS. While it is true that there identify potential values for work RVUs, more appropriate choice given the time must be a highest value for any such as time ratios, building blocks, and values and the efficiencies gained from particular subset of codes, we believe crosswalks to key reference or similar bundling. However, based on this the best approach in establishing work codes, in addition to the recommended recommended crosswalk code, we RVUs for codes is to compare the survey data. We also note that our believe that the RUC considers the service to other services with similar methodology generally values services patient population for CPT code 45378 times and identify codes with similar based on assumptions regarding the to be appropriate for comparison to CPT overall intensities. As we wrote in the typical case, not occasional code 36901, and that the reviewed code proposed rule with regards to CPT code complications that may require does not possess an unusually resource- 36901, we have reservations with RUC- additional work when they occur. For intensive patient population. This same

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pattern holds true for the other codes in description of the typical ESRD patient for CPT code 36902 based on these non- the Dialysis Circuit family, which were as 45 years old led to lower survey times typical situations. valued using similar comparisons to and hence the ‘‘new highest value’’ Comment: A commenter stated that established codes with typical patient problem mentioned by CMS. The the CMS proposed work RVU of 5.85 populations. commenter recommended that CMS undervalues the work involved in the Comment: One commenter suggested should finalize the RUC work RVU of services described by CPT code 36903, that the difficulties posed by the patient 3.36, or barring that, should finalize a based on the belief that the CPT patient population for the Dialysis Circuit codes work RVU of 3.02 based on a direct vignette does not reflect the typical were not sufficiently reflected in the crosswalk to CPT code 36200. The patient and that ‘‘additional vessel’’ RUC recommendations. The commenter commenter stated that this code is very angioplasty or stenting work is included stated that the patients receiving similar clinically in work and intensity in CPT code 36903 but was not able to dialysis circuit services are extremely to CPT code 36901. be captured in a survey utilizing the sick, and every step in the process of Response: We summarized and ‘‘typical’’ patient. caring for those patients is more responded to the general issues Response: We addressed these issues complex than those involved in caring surrounding patient populations above. in previous comment responses. We for the average Medicare patient. The We disagree with the commenter that continue to believe that the proposed commenter stated that CMS CPT code 36200 is a more appropriate work RVU for CPT code 36903 is underestimated the amount of time choice for a crosswalk code for CPT accurate. required to perform specific tasks and code 36901. CPT code 36200 has 5 Comment: A commenter disagreed assumes that those tasks can be additional minutes of intraservice time with the proposed work RVUs for CPT performed by individuals with lower (30 minutes as compared to 25 minutes) codes 36904 and 36905. The commenter levels of training and credentials than and 25 additional minutes of total time suggested that CMS should use time are used in typical practice. The (91 minutes as compared to 66 minutes). ratios from the base code in the family, commenter requested a series of direct In addition to this substantial difference CPT code 36901, starting from a work PE refinements to this family of codes, in time values, the intensity of CPT code RVU of 3.02 instead of the proposed many of which went above the original 36200 is also significantly lower than work RVU of 2.82. The commenter RUC recommendations, including CPT code 36901. If we were to adopt the suggested that this would produce work clinical labor times significantly above recommended crosswalk to a work RVU RVUs for CPT codes 36904 and 36905 the usual standards and using clinical of 3.02, the intensity of CPT code 36901 almost identical to the RUC- labor staffing types outside the normal would be 50 percent higher than the recommended values, which the range. The commenter stated an intensity CPT code 36200. Since we are commenter urged CMS to adopt. intention to present data to support the statutorily obligated to base our Response: We agree with the recommendations at a later date. valuation on time and intensity, we commenter that the use of time ratios is Response: We appreciate the believe that this makes CPT code 36200 one potential method to use in the additional information provided by the an inferior choice for a crosswalk code process of determining code valuation. commenter about this family of codes. when compared to our choice of CPT However, since we stated previously We emphasize that we do not believe code 44388, which shares very similar that we believe our proposed work RVU that the RUC need be the exclusive time and intensity with CPT code of 2.82 is more accurate for CPT code source of information used in valuation 36901. 36901 than the commenter’s suggestion of PFS services, and we are supportive Comment: A commenter stated that of 3.02, we do not believe that applying of the submission of additional data that CPT code 36902 should have a higher the same time ratios provides a rationale can aid in the process of determining increment in work RVU from CPT code for adopting the RUC-recommended the resources that are typically used to 36901 because it included work unable work RVUs for CPT codes 36904 and furnish these services. Because we did to be accounted for in a survey on the 36905. not receive data from the commenter to typical patient. The commenter Comment: A commenter disagreed support these increases above the RUC indicated that according to published with CMS’ proposed work RVU of 9.88 recommendations, we are not literature, more than one stenosis is for CPT code 36906 based upon the incorporating these changes into the present requiring angioplasty in 20–30 RUC-recommended increment of 7.06 Dialysis Circuit codes at this time. percent of dialysis access cases. A from CPT code 36901. The commenter However, we urge interested higher increment in work RVU from stated that the RUC value was well stakeholders to consider submitting CPT code 36901 to 36902 would reflect supported as the 25th percentile survey robust data regarding costs for these and the work of additional angioplasty on result and the survey times for the code other services. separate stenoses and arterial were adversely impacted by CPT errors We are also seeking information on angioplasty that occurs in some cases, in the code descriptor and RUC survey how to reconcile situations where we but cannot be reflected in a ‘‘typical’’ 51 limitations. have multiple sets of recommendations percent case vignette. The commenter Response: We do not agree that the from the RUC and from other PFS requested that CMS adopt the RUC- RUC’s work valuation for CPT code stakeholders, both for this specific case recommended work RVU for CPT code 36906 maintains relativity within the and for the situation more broadly, 36902. fee schedule. We believe that the given the need to maintain relativity Response: We generally establish increment between CPT code 36901 and among PFS services. RVUs for services based on the typical 36906 maintains relativity within the The following comments address the case. If a particular patient case requires Dialysis Circuit family of codes, which proposed work valuation of individual treatment outside the defined dialysis is why we proposed to use it for codes in the family. circuit code descriptor, then additional valuation. However, we believe that the Comment: A commenter contended catheter placement and imaging may be recommended work RVU for CPT code that the proposed work RVU of 2.82 reported, assuming that all of the proper 36906 insufficiently accounted for the undervalues CPT code 36901. The requirements for separate billing are efficiencies in resource use achieved commenter stated that compelling met. We do not believe that it would be through bundling together its evidence regarding CPT’s inaccurate appropriate to increase the work RVU predecessor codes. We continue to

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believe that the proposed work RVU of CPT codes 36904, 36905, and 36906. generally not included in similar 9.88, bracketed between crosswalks to Commenters stated that the patient procedures. We do not agree that the CPT codes 31546 and 61623, provides presentation and the requisite additional tasks described by the the most accurate valuation for this preservice clinical labor is inherently commenters would require the service. different for CPT codes 36904–36906 requested 5 minutes of clinical labor Comment: A commenter disagreed when compared with CPT codes 36901– time, and we are maintaining our with the proposed work RVU of 2.48 for 36903. Commenters indicated that the proposed value of 3 minutes. CPT code 36907, and stated that the latter group are elective procedures, Comment: Several commenters work RVU should be identical to CPT which are scheduled and planned well opposed the CMS proposal to remove code 37249 at a value of 2.97. The in advance of the procedure and the ‘‘kit, for percutaneous thrombolytic commenter stated these two services are performed on days that do not conflict device (Trerotola)’’ supply (SA015) from clinically identical, and the CMS with the patient’s dialysis schedule. In the RUC recommended supplies for CPT contention that CPT code 36907 would contrast, the former group are urgent code 36904, 36905, and 36906, under typically be a clinically less intense procedures typically done when a the belief that only one device would procedure is not correct. According to patient presents to their dialysis typically be used in these procedures. the commenter, the intensity involved treatment with a thrombosed access. Commenters indicated that this in both of these add-on codes is the According to the commenters, the understanding was incorrect. According work and risk of crossing the central urgent nature of these procedures, the to the commenters, a mechanical venous stenosis and performing need for additional preoperative testing thrombectomy device and a Fogarty intervention within the thorax where because of missed dialysis, and the need thrombectomy balloon serve different complications could be severe. The for arranging unscheduled dialysis purposes and both are necessary to commenter stated that there is no treatment requires additional preservice perform a dialysis access thrombectomy. difference in this work intensity based time for the procedural staff. Commenters provided lengthy clinical upon the direction of approach—from Response: We disagree with the rationales to support their point of view, the dialysis access or from a native commenters. We continue to note that which can be summarized as follows: (femoral) vein. Both require advancing a the preservice work description is ‘‘The Fogarty balloon is small and long wire from the access site through identical for all six of the 0-day global highly compliant allowing it to be the stenosis, superior and inferior vena codes in this family. Generally speaking, pulled through the artery and into the cava, and right atrium, which is needed we also typically provide less preservice access without damaging the vessels. no matter which direction one is clinical labor time for emergent The thrombectomy device cannot be approaching the lesion. As a result, the procedures, not more preservice clinical used safely for this function. This commenter suggested that CPT code labor time, as there is no time for these device is larger so risks pushing the 36907 should have the same work RVU tasks to be performed. We continue to fibrin plug into the artery if passed as CPT code 37249. believe that all six of these codes are across the arterial anastomosis from the Response: While we agree with the most accurately valued by sharing the access—risking distal arterial commenter that these two services are same preservice clinical labor times. clinically similar procedures, we do not Comment: Several commenters stated embolization. The device is also much agree with the commenter that the work that the recommended 5 minutes of more rigid being made from metal and between the two is identical. In clinical labor for ‘‘Prepare and position with irregular shape that risks damaging particular, we believe that the difference patient/monitor patient/set up IV’’ were the endothelium of the artery causing in the intraservice time (25 minutes for reasonable because these cases are done arterial injury.’’ As a result, commenters CPT code 36907 against 30 minutes for on the upper extremity using portable requested that the listed devices CPT code 37249) should be accounted c-arm fluoroscopy. According to ‘‘catheter, thrombectomy-Fogarty’’ for in the work valuation, as the former commenters, the additional time (SD032) and ‘‘kit, for percutaneous code takes 20 percent less time to includes prepping and positioning the thrombolytic device (Trerotola)’’ supply perform. We note as well that under our arm, applying appropriate shielding to (SA015) both remain in the supply list proposed valuation, these two codes the patient’s torso, positioning the c-arm for these codes. have exactly the same intensity, with unit, and then positioning other Response: We appreciated the the difference in the work value radiation shielding devices. detailed presentation of additional occurring solely as a result of the Commenters stated that each of these clinical information regarding the use of decreased time required to perform CPT activities requires more time in the arm, the percutaneous thrombolytic device code 36907. Since time is one of the which typically must be extended to the kit from the commenters. After review resources we are obligated to use for side to be accessible for access and of the comments and the contents of the code valuation, we believe that the imaging; this is different from kit, we believe that its inclusion in these proposed values for these two codes are procedures done in the long plane of the three procedures is appropriate. more accurate than setting both of them body including the torso and legs. The According to the device literature, the to the same work RVU. commenters stated that 5 minutes is a kit contains a rotor for macerating the Comment: One commenter supported more accurate reflection of the required clot, a catheter for removing the clot, the proposed work RVUs of 3.73 for CPT clinical labor time than the proposed 3 and a sheath for introducing the device. code 36908 and 3.48 for CPT code minutes. We will therefore restore the SA015 36909. Response: We continue to believe that supply to CPT codes 36904, 36905, and Response: We appreciate the support additional time may be needed for this 36906. However, we are removing the from the commenter. activity as compared to the default Fogarty catheter (SD032) and 1 of the 2 The following comments address the standard of 2 minutes. However, we vascular sheaths (SD136), as these are proposed direct PE inputs for the maintain that the commenter’s request contained within the kit. The literature Dialysis Circuit family of codes. for 3 additional minutes (for a total of for the percutaneous thrombolytic Comment: Several commenters urged 5 minutes) would not typically be device kit clearly stipulates that there is CMS to accept the recommended required for arm positioning, as this no need for additional catheters to additional preservice clinical labor for additional clinical labor time is remove the clot, which makes the

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Fogarty catheter a duplicative supply Chloraprep applicator (26 ml) supply, accurately size or locate tributaries and which can be removed. commenters indicated that Chloraprep lesions beneath the skin. The Comment: Several commenters solution has replaced Betadine solution commenter indicated that some of the disagreed with the CMS proposal to when performing sterile preparation of base procedure codes (CPT codes 36903 remove the recommended supply item the dialysis access circuit due to its and 36906) include this supply, while it ‘‘covered stent (VIABAHN, Gore)’’ greater efficacy as preoperative skin is missing from CPT codes 36902 and (SD254) and replace it with the ‘‘stent, prep. Commenters indicated that this 36905 and should be included. vascular, deployment system, Cordis supply was most accurately represented Response: Based upon SMART’’ (SA103) for CPT codes 36903 by the submitted invoice. Another recommendations from the RUC and and 36906. Commenters stated that commenter stated that studies have specialties, we believe that the use of covered stents are the only stent devices shown that preparation of central this supply is typical in stent that are FDA approved and supported venous sites with a 2% aqueous procedures such as CPT codes 36903 by evidence from randomized chlorhexidine gluconate (in 70% and 36906. It was included in CPT code controlled trials for use in dialysis alcohol) is superior for skin site 37238, which is a predecessor code for access procedures. They are typically preparation to either 10% povidone- these two procedures. However, the used in recurrent or elastic stenosis in iodine or 70% alcohol alone, and that in radio-opaque ruler does not appear to be dialysis access and have become the 2002, the CDC recommended that 2% typical in the other dialysis codes and standard of care for these interventions. chlorhexidine be used for skin we do not believe that it would be One commenter stated that Braid Forbes antisepsis prior to catheter insertion. typically required in the non-stent Health Research analyzed stent use in One commenter recommended that procedures, as it was not included in CPT code 37238 using CMS OPPS CMS replace the Betadine povidone any of the other predecessor codes. claims data, and found that the covered soln (SJ041) with two units of swab, Comment: One commenter requested stent (VIABAHN, Gore), was used 67.5 patient prep, 3.0 ml (Chloraprep) supply that CMS include additional percent of the time and the SA103, (SJ088) in the inputs for CPT codes miscellaneous supplies that were stent, vascular, deployment system, 36901–36906. missing or underrepresented in the cost Cordis SMART, was used 32.5 percent Response: We appreciate the inputs. These supplies were not of the time. Commenters stressed that submission of additional clinical included in the RUC recommendations bare metal stents, such as the Cordis information regarding the Chloraprep for these codes. The commenter also SMART, are not indicated for use in the supply from the commenters. We agree requested increasing the quantity of Dialysis Circuit procedures. with the recommended supply each category of gloves to 3 and the Response: We appreciate the substitution, and we are therefore quantity of gowns to 3 for each of the submission of this additional clinical removing 60 ml of the Betadine solution base codes (CPT codes 36901–36906) to information regarding the use of stents (SJ041) and replacing it with two units more accurately reflect the typical use of for these procedures. After of the swab, patient prep, 3.0 ml these items in the dialysis circuit consideration of the comments, we are (Chloraprep) supply (SJ088) for CPT procedures. restoring the covered stent (VIABAHN, codes 36901–36906. We will add the Response: We believe the supplies as Gore) (SD254) to CPT codes 36903 and Chloraprep applicator (26 ml) supply to recommended are typical for these 36906 as originally recommended. the direct PE input database at a price procedures. We also believe the Because we are including the SD254 of $8.48 based on an average of the three proposed number of gloves and gowns covered stent, we are not adding the submitted invoices; it is not currently would be sufficient for the typical case; stent, vascular, deployment system, assigned to any codes. We also agree we currently do not have any data to Cordis SMART (SA103) supply to these that it is a distinct supply from the suggest that there is a need for procedures. ‘‘chlorhexidine 4.0% (Hibiclens)’’ additional gloves or gowns in these Comment: Several commenters (SH098) supply already located in the procedures. The remainder of the disagreed with the CMS proposal to direct PE database. additional miscellaneous items appear reduce the quantity of the Hemostatic Comment: Several commenters to be new supplies with no included patch (SG095) from 2 to 1 for CPT codes provided additional information invoices. Many of these new items may 36904, 36905, and 36906. Commenters regarding the use of guidewires in these have analogous supplies already present stated that two hemostatic patches are procedures. Commenters stated that the in our direct PE database. For the others, necessary in these procedures because three wires used in the Dialysis Circuit we will consider pricing them if they require two separate cannulations codes are the minimum required for invoices are submitted as part of our and sheaths. At the end of the case, both these interventions and frequently normal process for updating supply and sheath sites are removed and covered additional wires would be needed in equipment costs. with a hemostatic patch which aids in more complicated cases or in cases in After consideration of comments preventing bleeding and maintaining which more than one access must be received, we are finalizing the work sterility. The commenters stressed that used. Commenters stated that the RVUs for the Dialysis Circuit codes as because there are two access sites, two guidewires submitted are the bare proposed. We are also finalizing the hemostatic patches are required, one to minimum needed for the typical case. proposed direct PE inputs, with the cover each site. Response: We appreciate the refinements detailed above. Response: We appreciate the additional information from the additional clinical information commenters regarding the use of (17) Open and Percutaneous submitted by the commenters. In guidewires. We proposed to use the Transluminal Angioplasty (CPT Codes response to this information, we are RUC-recommended quantities for these 37246, 37247, 37248, and 37249) finalizing inclusion of the second supplies, and we are not finalizing any In January 2015, a CPT/RUC Hemostatic patch (SG095) to CPT codes changes. workgroup identified the following CPT 36904, 36905, and 36906, as Comment: One commenter stated that codes as being frequently reported recommended by the RUC. vascular procedures involving together in various combinations: 35475 Comment: In response to the CMS fluoroscopy or radiography require the (Transluminal balloon angioplasty, solicitation of feedback regarding the use of a radio-opaque ruler (SD249) to percutaneous; brachiocephalic trunk or

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branches, each vessel), 35476 recommended work RVU for CPT codes positioned on an arm board, and (Transluminal balloon angioplasty, 37246, 37247, 37248, and 37249. requested time for this activity. percutaneous; venous), 36147 For the clinical labor direct PE inputs, Recommended: We continue to (Introduction of needle and/or catheter, we proposed to use the RUC- believe that additional time may be arteriovenous shunt created for dialysis recommend inputs with several needed for this activity as compared to (graft/fistula); initial access with refinements. Our proposed inputs the default standard of 2 minutes. complete radiological evaluation of refined the recommended clinical labor However, we maintain that the dialysis access, including fluoroscopy, time for ‘‘Prepare and position patient/ commenter’s request for 3 additional image documentation and report), 36148 monitor patient/set up IV’’ from 5 minutes (for a total of 5 minutes) would (Introduction of needle and/or catheter, minutes to 3 minutes for CPT codes not typically be required for preparing arteriovenous shunt created for dialysis 37246 and 37248. The RUC the X-ray and conducting arm (graft/fistula); additional access for recommendation included a written positioning. We do not agree that the therapeutic intervention), 37236 justification for additional clinical labor additional tasks described by the commenters would require the (Transcatheter placement of an time beyond the standard 2 minutes for requested 5 minutes of clinical labor intravascular stent(s) (except lower this activity, stating that the extra time time, and we are maintaining our extremity artery(s) for occlusive disease, was needed to move leads out of X-ray proposed value of 3 minutes. cervical carotid, extracranial vertebral or field, check that X-ray is not obstructed and that there is no risk of collision of Comment: Several commenters intrathoracic carotid, intracranial, or objected to the proposed replacement of coronary), open or percutaneous, X-ray equipment with patient. As we wrote for the same clinical labor activity the ‘‘drape, sterile, femoral’’ supply including radiological supervision and (SB009) with the ‘‘drape, sterile, interpretation and including all in the Dialysis Circuit family, we agreed that extra time might be needed for this fenestrated 16in x 29in’’ supply (SB011) angioplasty within the same vessel, for CPT codes 37246 and 37248. when performed; initial artery), 37238 activity as compared to the default standard of 2 minutes; however, we Commenters stated that the vast (Transcatheter placement of an majority of these new procedures will intravascular stent(s), open or assigned 1 extra minute for the additional positioning tasks, resulting in be performed from a femoral or jugular percutaneous, including radiological approach and will utilize a standard a total of 3 minutes for this task. We did supervision and interpretation and femoral drape. According to the not believe that 3 extra minutes would including angioplasty within the same commenters, the fenestrated drape be typically needed for preparation of vessel, when performed; initial vein), provides a limited sterile field (16x29in) the X-ray. The equipment times for the 75791 (Angiography, arteriovenous which does not allow room for sterile angiography room (EL011) and the shunt (eg, dialysis patient fistula/graft), manipulation of wires and catheters as PACS workstation (ED050) were also complete evaluation of dialysis access, they extend away from the entry into refined to reflect this change in clinical including fluoroscopy, image the vascular system. With the creation labor. documentation and report (includes of the new dialysis access circuit CPT We proposed to remove the ‘‘drape, injections of contrast and all necessary code family, commenters indicated that sterile, femoral’’ supply (SB009) and imaging from the arterial anastomosis the use of extremity access and replace it with a ‘‘drape, sterile, and adjacent artery through entire fenestrated drapes would become much fenestrated 16in x 29in’’ supply (SB011) venous outflow including the inferior or less typical for the new angioplasty code for CPT codes 37246 and 37248. The superior vena cava), radiological set. two base codes out of which these new supervision and interpretation), 75962 Response: We appreciate the codes are being constructed, CPT codes (Transluminal balloon angioplasty, presentation of additional clinical 35471 and 35476, both made use of the peripheral artery other than renal, or information from the commenters SB011 fenestrated sterile drape supply, regarding the sterile drape most other visceral artery, iliac or lower and there was no rationale provided for extremity, radiological supervision and appropriate for these procedures. As a the switch to the SB009 femoral sterile result, we are finalizing inclusion of the interpretation), and 75968 drape in the two new codes. We (Transluminal balloon angioplasty, each sterile femoral drape supply (SB009) to solicited comment on the use of sterile CPT codes 37246 and 37248. We will additional visceral artery, radiological drapes for these procedures, and what supervision and interpretation). therefore not be adding the fenestrated rationale there was to support the use of drape supply (SB011) to these At the October 2015 CPT Editorial the SB009 femoral sterile drape as procedures. Panel meeting, the panel approved the typical for these new procedures. After consideration of comments creation of four new codes and deletion The following is a summary of the received, we are finalizing the proposed of 13 existing codes used to describe comments we received regarding our work RVUs for the four codes in the bundled percutaneous transluminal proposed valuation of the Open and family. We are also finalizing the angioplasty services. The Open and Percutaneous Transluminal Angioplasty proposed direct PE inputs, with the Percutaneous Transluminal Angioplasty codes. refinement to the sterile femoral drape family of codes overlaps with the Comment: One commenter disagreed detailed above. Dialysis Circuit family of codes (CPT with the CMS proposed value of 3 codes 36901–36909), as they are both minutes for the ‘‘Prepare and position (18) Esophagogastric Fundoplasty being constructed from the same set of patient/monitor patient/set up IV’’ Trans-Oral Approach (CPT Code 43210) frequently reported together codes. We clinical labor task. The commenter For CY 2016, the CPT Editorial Panel reviewed these two families of codes stated that the recommended 5 minutes established CPT code 43210 to describe concurrently to maintain relativity of time was needed to move leads out trans-oral esophagogastric fundoplasty. between these clinically similar of X-ray field, check that X-ray is not The RUC recommended a work RVU of procedures based upon the same obstructed and that there is no risk of 9.00 and for CY 2016, we established an collection of deleted codes. After collision of X-ray equipment with interim final work RVU of 7.75 for CPT consideration of these materials, we patient. The commenter also indicated code 43210. We noted that a work RVU proposed to accept the RUC- that the patient’s arm needs to be of 7.75, which corresponds to the 25th

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percentile of the survey, more this is a new technology. Commenters myotomy, includes use of telescope or accurately reflected the resources used requested that CMS finalize the RUC- operating microscope and repair, when in furnishing this service. recommended work RVU of 9.00, with performed), which has a work RVU of Comment on the CY 2016 PFS final the understanding that the service will 9.03 and has identical intraservice time rule with comment period: Commenters be reviewed again in the near future and similar total time. We stated in the urged CMS to accept the RUC- with more robust survey data as the proposed rule that we believe the recommended work RVU of 9.00 for technology continues to be adopted. overall intensity of these procedures is CPT code 43210. The commenters Commenters disagreed with CMS’ similar; therefore, we proposed a work believed that the RUC-recommended comparison to other EGD codes for RVU of 9.03 for CPT code 43284. value compared well with the key purposes of establishing the work RVU, For CPT code 43285, the RUC reference service, CPT code 43276 due to differences in the inherent recommended a work RVU of 10.47. We (Endoscopic retrograde clinical procedural steps involved with used the increment between the RUC- cholangiopancreatography (ERCP); with this code, including that EGD is used recommended work RVU for this code removal and exchange of stent(s), biliary more than once (pre- and post- and CPT code 43284 (0.34 RVUs) to or pancreatic duct, including pre- and fundoplication) to ensure successful develop our proposed work RVU of 9.37 post-dilation and guide wire passage, completion of the procedure. for CPT code 43285. when performed, including Response: While it may be true that Comment: We received many sphincterotomy, when performed, each multiple EGDs may be performed during comments on our proposal from various stent exchanged), which has a work this procedure, the surveyees are stakeholders including practitioners, RVU of 8.94 and an intraservice time of familiar with the service and we assume manufacturers, the RUC, and medical 60 minutes. Commenters believed that included this information in their specialty societies representing various due to similar intraservice times and proposed time and work surgical specialties. For CPT code intensities, that CPT code 43210 should recommendations. However, the values 43284, commenters indicated that CMS’ be valued nearly identically to CPT code recommended by the survey and the proposed crosswalk from CPT code 43276. Some commenters also stated RUC are not consistent with other codes 43180 was inadequate with regard to that to maintain relativity within the with similar times and intensities. We time and complexity of the services. upper GI code families, CPT code 43210 noted in the CY 2016 interim final rule Commenters stated that CPT code 43180 should not have a lower work RVU than that CPT code 43240 (Drainage of cyst has 10 minutes less immediate post- CPT code 43276 since the majority of of the esophagus, stomach, and/or upper service time and one less post-operative survey participants indicated that CPT small bowel using an endoscope) has 10 visit. Some commenters stated that it code 43210 is more complex than CPT minutes more intraservice time and a appears that the difference between the code 43276. Additionally, one work RVU of 7.25. Therefore, we are specialty society median survey total commenter noted that an finalizing for CY 2017 a work RVU of time for 43284 and the total time for esophagogastroduodenoscopy (EGD) is 7.75 for CPT code 43210. CMS’ proposed crosswalk from CPT used twice during this service, before (19) Esophageal Sphincter and after fundoplication. The code 43180 was too great to discount. Augmentation (CPT Codes 43284 and commenter stated that because this is a Commenters also disagreed that CPT 43285) multi-stage procedure, other EGD codes code 43284 and CMS’ proposed are not comparable. The commenter also In October 2015, the CPT Editorial crosswalk from CPT code 43180 had pointed out that this technology has a Panel created two new codes to describe similar complexity considering that one small number of users and urged CMS laparoscopic implantation and removal of the procedures was performed on a to accept the RUC-recommended work of a magnetic bead sphincter natural orifice with endoscopy versus a RVU of 9.00 until there is additional augmentation device used for treatment procedure with a surgical incision. utilization, and to consider reviewing of gastroesophageal reflux disease Commenters indicated that management this code again in subsequent years. (GERD). The RUC noted that the of surgical patients with incisions Response in the CY 2017 PFS specialty societies conducted a targeted necessitates a more thorough evaluation proposed rule: We referred this code to survey of the 145 physicians who have of the body than an endoscopic the CY 2016 multi-specialty refinement been trained to furnish these services procedure. panel for further review, which and who are the only physicians who For CPT code 43285, commenters recommended we accept the RUC- have performed these procedures. They noted that although CPT code 47562 recommended value of 9.00 work RVUs. noted that only 18 non-conflicted (the RUC-recommended crosswalk) There are four ERCP codes with 60 survey responses were received despite requires more intraservice time than the minutes of intraservice time, three of efforts to follow up and that nine aggregate survey median time for CPT which have work RVUs of less than 7.00 physicians had no experience in the code 43285, the median intraservice and only one of the four codes has a past 12 months with the procedure. The time may be understated because of the work RVU higher than 7.75 RVUs (8.94). RUC agreed with the specialty society number of people without experience, Based on our estimate of overall work that the expertise of those responding and suggested that the total time for CPT for this service, we continue to believe was sufficient to consider the survey; codes 43285 and 47562 is nearly that the 25th percentile of the survey however, neither the RUC nor the identical and both require similar work more accurately reflects the relative specialty society used the survey results and intensity. Commenters stated that resource costs associated with this as the primary basis for their only 18 non-conflicted survey responses service. Therefore, for CY 2017, we recommended value. were received despite the efforts of the proposed a work RVU of 7.75 for CPT For CPT code 43284, the RUC specialty societies, and that nine code 43210. recommended a work RVU of 10.13. We physicians had no experience with the The following is a summary of the compared this code to CPT code 43180 procedure in the past 12 months. comments we received regarding our (Esophagoscopy, rigid, transoral with Commenters also noted that the RUC proposed valuation of CPT code 43210: diverticulectomy of hypopharynx or recommendations used the specialty Comment: Commenters indicated that cervical esophagus (e.g., Zenker’s society survey times, but provided a the survey results were limited since diverticulum), with cricopharyngeal crosswalk for work RVU valuation.

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Many commenters expressed the interim final status of these subject to alterations in their work RVUs additional concerns about the specialty procedures. or work times since the moderate society survey data, indicating that the We received several comments sedation code with work RVUs and survey median and 25th percentile work regarding the CMS refinements to the work time (99152) will only be billed RVUs were inconsistent with the total work values for this family of codes in once for each base-code and not physician work for services reported the CY 2016 final rule with comment additionally with the add-on codes. with CPT codes 43284 and 43285. period. The relevance of many of these These changes are reflected in Commenters stated that to accept the comments has been diminished by the Appendix B and the work time file results of the survey is to essentially new series of RUC recommendations for posted to the web; see section II.D for state that the opinions of inexperienced work values that we received as a result more details. surgeons is adequate to determine the of the October 2015 meeting. Given that For the direct PE inputs, we did not value of a surgical procedure and lacked we proposed the updated RUC- propose to include the recommended input from surgeons experienced in recommended work RVUs for CPT L051A clinical labor for ‘‘Sedate/apply performing the procedure. Commenters codes 47531, 47532, 47533, 47534, anesthesia’’ and the L037D for ‘‘Assist suggested that CMS maintain carrier 47535, 47536, 47537, 47538, 47539, Physician in Performing Procedure’’ for pricing for services reported with CPT 47540, 47542, 47543, and 47544, we CPT codes 47531 and 47537. As we codes 43284 and 43285 while the solicited additional comments relative wrote in the CY 2016 final rule with specialty societies conduct new surveys to these proposed values. We agreed comment period (80 FR 71053), we that include data from surgeons that the second round of physician believe that this clinical labor describes experienced with the procedures. Some surveys conducted for the October 2015 activities associated with moderate commenters suggested that the work of RUC meeting more accurately captured sedation, and moderate sedation is not CPT codes 43284 and/or 43285 is more the work and time required to perform typical for these procedures. We also similar to fundoplication procedures these procedures. The one exception proposed to refine the L037D clinical reported with CPT code 43280 (a work was CPT code 47541; the survey times labor for ‘‘Clean room/equipment by RVU of 18.10). Other commenters for this procedure were identical as physician staff’’ from 6 minutes to 3 suggested valuations for these conducted for the April and October minutes for all of the codes in this procedures ranging from 14 to 17 work 2015 RUC meetings, yet the RUC family. Three minutes is the standard RVUs, stating that the services reported recommendation increased from a work for this clinical labor activity, and we with CPT codes 43284 and 43285 were RVU of 5.61 in April to a work RVU of continued to maintain that the need for slightly less complicated than 7.00 in October. Given that the time additional clinical labor time for this fundoplication procedures, but more values for the procedure remained cleaning activity would not be typical complex than the valuations reflected in unchanged between the two surveys, we for these procedures. the survey results, RUC do not understand why the work RVU Comment on the CY 2016 PFS final recommendations, and CMS proposed would have increased by nearly 1.50 in rule with comment period: One values. the intervening months. Since this code commenter disagreed with our Response: We appreciate the feedback also has an identical intraservice time refinement to replace supply item received from stakeholders regarding (60 minutes) and total time (121 ‘‘catheter, balloon, PTA’’ (SD152) with valuation of these services. After minutes) as CPT code 47533, we do not supply item ‘‘catheter, balloon ureteral considering the comments received, for agree that it should be valued at a (Dowd)’’ (SD150). The commenter stated CY 2017, we are finalizing the RUC- substantially higher rate compared to a that a Dowd catheter is designed and recommended values for CPT codes medically similar procedure within the FDA approved for use in the prostatic 43284 (a work RVU of 10.13) and 43285 same code family. We therefore urethra by retrograde placement through (a work RVU of 10.47). We recognize proposed to crosswalk the work value of the penile urethra, and it is not designed commenters’ concerns regarding the CPT code 47541 to the work value of for use in an antegrade ureteral dilation specialty society survey data and CPT code 47533, and we proposed a procedure. The commenter stated that believe these codes may be potentially work RVU of 5.63 for both procedures. this replacement is inappropriate. The misvalued. We look forward to receiving We also note that many of the codes updated RUC recommendations for this feedback from interested parties and in the Percutaneous Biliary Procedures family of codes also restored the balloon specialty societies regarding accurate family were previously included in PTA catheter. valuation of these services for Appendix G, and were valued under the Response in the CY 2017 PFS consideration during future rulemaking. assumption that moderate sedation was proposed rule: We proposed again to typically performed on the patient. As replace the recommended supply item (20) Percutaneous Biliary Procedures part of the changes for services ‘‘catheter, balloon, PTA’’ (SD152) with Bundling (CPT Codes 47531, 47532, previously valued with moderate supply item ‘‘catheter, balloon ureteral 47533, 47534, 47535, 47536, 47537, sedation as inherent, we are removing a (Dowd)’’ (SD150). We believed that the 47538, 47539, 47540, 47541, 47542, portion of the work RVU and preservice use of this ureteral balloon catheter, 47543, and 47544) work time from CPT codes 47532, which is specifically designed for This group of fourteen codes was 47533, 47534, 47535, 47536, 47538, catheter and image guidance reviewed by the RUC at the April 2015 47539, 47540, and 47541. For example, procedures, would be more typical than meeting. We established interim final we proposed a work value for CPT code the use of a PTA balloon catheter. While values for this group of codes during the 47541 with a 0.25 reduction from 5.63 we recognize that the Dowd catheter is CY 2016 PFS rulemaking cycle, and to 5.38, and a 10 minute reduction in its not FDA approved, it is our subsequently received updated RUC preservice work time from 33 minutes to understanding that the PTA balloon recommendations from the October 23 minutes, to reflect the work that will catheter has also not been FDA 2015 meeting for the CY 2017 PFS now be reported separately using the approved for use in these procedures. rulemaking cycle. Our proposals for new moderate sedation codes. CPT We were uncertain if the commenter these codes incorporated both the codes 47542, 47533, and 47544 also was requesting that we should no longer updated RUC recommendations, as well were valued with moderate sedation; include catheters that lack FDA as public comments received as part of however, as add-on codes, they are not approval in the direct PE database; this

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would preclude the use of most of the 7.00 after removing 0.25 RVUs to Medical). According to commenters, catheters in our direct PE database. We account for the fact that moderate these sizes are frequently inadequate to solicited additional comment on the use sedation will now be billed separately treat the wide variety of pathologies in of FDA approved catheters; in the for this service. the biliary tree where often balloon sizes meantime, we continued our long- Comment: One commenter requested up to 12 mm are required. As a result, standing practice of using the catheters 2 minutes for the clinical labor task the commenters stated that the change in the direct PE database without ‘‘Sedate/apply anesthesia’’ and 15 of the balloon catheter supply item does explicit regard to FDA approval in minutes for the clinical labor task not accurately represents the actual particular procedures. ‘‘Assist Physician in Performing supplies utilized in real practice, nor We also proposed to remove the Procedure’’ for CPT codes 47531 and does the Dowd ureteral balloon catheter recommended supply item ‘‘stone 47537. The commenter agreed with satisfy the clinical need performed basket’’ (SD315) from CPT code 47543 CMS that moderate sedation was not during the procedure. and add it to CPT code 47544. Based on typical for either procedure, but stated Response: We appreciate the the code descriptors, we believed that that the 2 minutes was for the RN to additional clinical information supplied the stone basket was intended to be administer the pre-procedure by the commenters regarding the current included in CPT code 47544 and was prophylactic antibiotics and the 15 use of balloon catheters. However, erroneously listed under CPT code minutes for assisting the physician was although commenters stated that Bard 47543. We solicited comments from the unrelated to moderate sedation. catheters and Cook Medical catheters public to help clarify this issue. Response: We disagree with the are frequently too small to treat some of We noted again that many of the commenter that the clinical labor time the wide variety of pathologies that codes in the Percutaneous Biliary for these tasks would be typical for CPT occur in the biliary tree, commenters Procedures family were previously codes 47531 and 47537. For the 2 did not indicate what size balloon included in Appendix G, and as part of minutes of apply anesthesia time, we do catheter would be typically used for the change in moderate sedation not agree that this clinical labor time these particular procedures in the reporting, we removed some of the should be assigned when the clinical Percutaneous Biliary Procedures, or recommended direct PE inputs related staff is performing an entirely different provide a specific rationale for why the to moderate sedation from CPT codes activity. We have not assigned clinical catheter we proposed (the Dowd 47532, 47533, 47534, 47535, 47536, labor time in this way in the past, and ureteral balloon catheter) would not be 47538, 47539, 47540, and 47541. We the request for 2 minutes related to appropriate for these procedures. We removed the L051A clinical labor time administering pre-procedure note again that we are required to assess for ‘‘Sedate/apply anesthesia’’, ‘‘Assist prophylactic antibiotics was never resources based on the typical case, and Physician in Performing Procedure discussed in the recommendations for the commenters did not provide data to (CS)’’, and ‘‘Monitor pt. following these procedures. indicate that the proposed Dowd moderate sedation’’. We also removed For the 15 minutes of assist physician catheter would be inadequate in the the conscious sedation pack (SA044) time, the commenter did not provide a typical case for these procedures in supply, and some or all of the justification for why an additional staff question, only that it may be insufficient equipment time for the stretcher member would be needed or what the for certain pathologies in the biliary (EF018), the mobile instrument table staff member would be doing. CPT tree. We continue to believe that the (EF027), the 3-channel ECG (EQ011), codes 47531 and 47537 already contain Dowd ureteral balloon catheter, which and the IV infusion pump (EQ032). two clinical staff members, one is specifically designed for catheter and These changes are reflected in the technician to assist the physician and image guidance procedures, would be public use files posted to the web; see another technician to acquire images, more typical than the use of a PTA section II.D for more details. plus a circulator. The other codes in the balloon catheter. The following is a summary of the Percutaneous Biliary Procedures family Comment: One commenter indicated comments we received regarding our previously had a third RN clinical staff that the stone basket supply (SD315) proposed valuation of the Percutaneous member to administer the sedation to had indeed been incorrectly assigned to Biliary Procedures codes. the patient, before moderate sedation CPT code 47543, and thanked CMS for Comment: Several commenters was split off into its own separate moving it to CPT code 47544 where it disagreed with the proposed work RVU procedure codes. However, CPT codes was intended. of 5.45 for CPT code 47541. 47531 and 47537 do not typically Response: We appreciate the response Commenters stated that although CPT require sedation, and we do not agree from the commenter. codes 47541 and 47533 share similar that this additional clinical staff After consideration of comments time values, the patient population for member would be required to perform received, we are finalizing our proposed CPT code 47541 is more complex with the procedures. work RVUs for the Percutaneous Biliary post-surgical anatomy and atypical Comment: Several commenters again Procedures family of codes, with the problems. Therefore, the commenters objected to the proposed replacement of one change to a work RVU of 6.75 for stated that the direct crosswalk creates the recommended supply item CPT code 47541. We are finalizing our a sharp rank order anomaly within the ‘‘catheter, balloon, PTA’’ (SD152) with proposed direct PE inputs without family, and requested that CMS adopt supply item ‘‘catheter, balloon ureteral refinement. the RUC-recommended work RVU. (Dowd)’’ (SD150). Commenters stated Response: We agree with the that this would not reflect the practice (21) Percutaneous Image Guided commenters that the proposed work patterns of the Interventional Radiology Sclerotherapy (CPT Code 49185) RVU for CPT code 47541 has the community, as it is atypical and even For CY 2016, we established an potential to create an anomalous quite rare to use ureteral balloon interim final work RVU of 2.35 for CPT relationship between the services in this dilatation catheters in the biliary tree. code 49185 based on a crosswalk from family of codes. After considering the The commenters provided information CPT code 62305 (Myelography via comments, we are finalizing a work regarding the size of uretal balloon lumbar injection, including radiological RVU of 6.75 for CPT code 47541, which catheters, indicating that the maximum supervision and interpretation; 2 or is the RUC-recommended work RVU of diameter is 8mm (Bard) or 7mm (Cook more regions (e.g., lumbar/thoracic,

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cervical/thoracic, lumbar/cervical, period, but proposed to refine the direct frequent recurrence necessitating lumbar/thoracic/cervical)); which we practice expense inputs for the additional procedures. believed accurately reflected the time sclerosing solution (supply item SH062) Response: We appreciate the and intensity involved in furnishing from 300 mL to 10 mL, which is the commenters’ feedback regarding the services reported with CPT code 49185. highest level associated with other CPT direct PE inputs for CPT code 49185. We also requested stakeholder input on codes utilizing sclerosing solution. We inadvertently included the RUC- the price of sclerosing solution (supply The following is a summary of the recommended quantity of 300 mL for item SH062) as the volume of the comments we received regarding our the sclerosing solution (supply item solution in this procedure (300 mL) is proposed valuation of CPT code 49185. SH062) in developing the proposed much higher than other CPT codes Comment: Commenters requested that rates for this code. For CY 2017, we are utilizing sclerosing solution (between 1 CMS use the RUC-recommended finalizing the RUC-recommended direct and 10 mL). crosswalk from CPT code 31622 instead PE inputs, including 300 mL of Comment on the CY 2016 PFS final of the CMS-proposed crosswalk from sclerosing solution. We welcome rule with comment period: In response CPT code 62305. Commenters stated stakeholder feedback regarding the to the CY 2016 PFS final rule with that CMS’ crosswalk undervalues the appropriate PE inputs for this procedure comment period (80 FR 71054), services, the RUC-recommended for consideration for CY 2018, including commenters disagreed with CMS’ crosswalk has analougous clinical volume and pricing of the sclerosing crosswalk from CPT code 62305. activities during the procedure, as well agent. Commenters suggested that the RUC’s as a similar risk, and the intensity of (22) Genitourinary Procedures (CPT recommended crosswalk from CPT code work involved for services reported Codes 50606, 50705, and 50706) 31622 (Bronchoscopy, rigid or flexible, with CMS’ comparison code is less than including fluoroscopic guidance, when during sclerotherapy. Commenters In the CY 2016 PFS final rule with performed; diagnostic, with cell suggested that the sclerotherapy comment period, we established as washing, when performed (separate procedure includes inherent risks and interim final the RUC-recommended procedure)) was a more appropriate challenges that are not adequately work RVUs for all three codes. We did comparison due to the similarity of the accounted for in CMS’ proposed not receive any comments on the work services. Commenters requested that crosswalk. values for these codes, and we proposed CPT code 49185 be referred to the Response: We disagree with to maintain all three at their current refinement panel. The requests did not commenters that the RUC’s work RVUs. meet the requirements related to new recommended crosswalk from CPT code The RUC recommended the inclusion clinical information for referral to the 31622 has analogous clinical activities of ‘‘room, angiography’’ (EL011) for this refinement panel. We continue to compared to CMS’ proposed crosswalk family of codes. As we discussed in the believe that for CPT code 49185 a from CPT code 62305. CMS’ crosswalk CY 2016 PFS final rule with comment crosswalk from the value of CPT code code refers to a procedure with period, we did not believe that an 62305 is accurate due to similarities in injection, drainage, and aspiration, angiography room would be used in the overall work. which has more clinical similarity to typical case for these procedures, and Commenters also stated that the CPT code 49185 than the RUC’s we therefore replaced the recommended procedure reported with CPT code recommended crosswalk from 31622, equipment item ‘‘room, angiography’’ 49185 required a separate clinical labor which is used to report a broncoscopy with equipment item ‘‘room, staff type. The commenter noted that, procedure. We continue to believe that radiographic-fluoroscopic’’ (EL014) for due to the inclusion of this additional a work RVU of 2.35 is an appropriate all three codes on an interim final basis. individual, the L037D clinical labor and valuation for services reported using We also stated our belief that since the additional gloves were appropriate to CPT code 49185 and we maintain that predecessor procedure codes generally include in the procedure. The CPT code 62305 is an accurate did not include an angiography room commenter did not provide any crosswalk, since CPT codes 49185 and and we did not have a reason to believe evidence for this claim. 62305 have similar service times. that the procedure would have shifted Response in the CY 2017 PFS Therefore, for CY 2017, we are finalizing to an angiography room in the course of proposed rule: We continue to believe a work RVU of 2.35 for CPT code 49185. this coding change, we did not believe that this additional use of clinical staff Comment: Commenters disagreed that the use of an angiography room would not be typical for CPT code with CMS’ proposal to include a direct would be typical for these procedures. 49185. This procedure does not involve PE input of 10 mL of sclerosing solution Comment on the CY 2016 PFS final moderate sedation, and therefore, we do (supply item SH062) and requested that rule with comment period: Several not believe that there would be a typical CMS accept the RUC’s recommendation commenters disagreed with the CMS need for a third staff member. to include 300 ml of sclerosing solution substitution of the fluoroscopic room in Additionally, we did not receive any as part of the direct PE inputs for this place of the angiography room. The information regarding the sclerosing procedure. One commenter indicated commenters stated that all three of these solution (supply item SH062) that that other services that utilize sclerosing procedures were previously reported supports maintaining an input of 300 solution are used to describe injection of using CPT code 53899 (Unlisted mL, which far exceeds the volume sclerosant into vascular structures procedure, urinary system) which does associated with other CPT codes. which tend to be relatively small in size, not have any PE inputs, and the RUC Therefore, for CY 2017, we proposed and therefore, use a much smaller recommendations included as a a work RVU of 2.35 for CPT code 49185. volume. Another commenter stated that reference CPT code 50387 (Removal and We sought stakeholder feedback for this procedure, the sclerosing replacement of externally accessible regarding why a different work RVU or solution is injected and drained three transnephric ureteral stent), which crosswalk would more accurately reflect separate times, equating to 100 mL per includes an angiography room. The the resources involved in furnishing this injection, and that use of lesser volumes commenters suggested that CPT code service. We also proposed to maintain of sclerosant or less than three 50387 was an example of a predecessor our direct PE refinements from the CY administrations of the sclerosant during code that included the use of an 2016 PFS final rule with comment the procedure would allow for more angiography room, along with other

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codes that are being bundled together to patients. The commenter indicated that these Genitourinary procedures. We create the new Genitourinary codes. the only piece of equipment listed in the lacked pricing information for these Response in the CY 2017 PFS angiography room that would not be components; we therefore proposed to proposed rule: We did not agree with typically utilized for these procedures is include each of these components in the the commenters’ implication that the Provis Injector. All of the other direct PE input database at a price of because CPT code 50387 was an items were used for these Genitourinary $0.00 and we solicited invoices from the appropriate reference code for use in procedures. The commenter urged CMS public for their costs to be able to price valuation, that it necessarily would have to restore the angiography room to these these items for use in developing final previously been used to describe procedures. PE RVUs for CY 2017. services that are now reported under Response in the CY 2017 PFS We also noted that we believed that CPT codes 50606, 50705, or 50706. Our proposed rule: We agreed that it is this issue illustrated a potentially broad perspective was consistent with the important to provide equipment that is problem with our use of equipment RUC-recommended utilization medically reasonable and necessary. ‘‘rooms’’ in the direct PE input database. crosswalk for the three new codes, Our concern with the use of the For most services, we only include which did not suggest that the services angiography room for these codes was equipment items that are used and were previously reported using 50706. that we did not believe all of the unavailable for other uses due to their We did not believe that use of one equipment would be typically necessary use during the services described by a particular code for reference in to furnish the procedure. For example, particular code. However, for items developing values for another the commenter agreed that the Provis included in equipment ‘‘rooms,’’ we necessarily meant that the all of the Injector would not be required for these allocate costs regardless of whether the same equipment would be used for both Genitourinary codes. Therefore, we individual items that comprise the room services. proposed to remove the angiography are actually used in the particular We did not believe that these codes room from these three procedures and service. described the same clinical work either. add in its place the component parts To maintain relativity among different CPT code 50387 is for the ‘‘Removal and that make up the room. Table 17 kinds of procedures, we were interested replacement of externally accessible detailed these components: in obtaining more information transnephric ureteral stent’’ while CPT specifying the exact resources used in code 50606 describes an ‘‘Endoluminal TABLE 17—ANGIOGRAPHY ROOM furnishing services described by biopsy of ureter and/or renal pelvis’’, (EL011) COMPONENTS different codes. We hoped to address CPT code 50705 refers to ‘‘Ureteral this subject in greater detail in future embolization or occlusion’’, and CPT Component rulemaking. code 50706 details ‘‘Balloon dilation, The following is a summary of the ureteral stricture.’’ Additionally, the 100 KW at 100 kV (DIN6822) generator comments we received regarding our codes do not have the same global C-arm single plane system, ceiling mounted, proposed valuation of the Genitourinary periods, which makes comparisons integrated multispace codes: between CPT code 50387 and CPT codes T motorized rotation, multiple operating Comment: Many commenters objected 506060, 50705, and 50706 even more modes to the removal of the angiography room Real-time digital imaging difficult. We noted that while the from these codes and its replacement 40 cm image intensifier at 40/28/20/14cm with the component parts of the room. commenter stated that CPT code 50387 30 x 38 image intensifier dynamic flat panel was provided as a reference for these detector Commenters stated that it was procedures, 50387 is not listed as a Floor-mounted patient table with floating ta- misguided to unbundle the components reference for any of these three codes, or bletop designed for angiographic exams of the angiography room when one mentioned at all in the codes’ respective and interventions (with peistepping for equipment item within the room is not summary of recommendations. image intensifiers 13in+) utilized. They indicated that there are However, we acknowledged that among 18 in TFT monitor numerous cases where an equipment the procedures that are provided as Network interface (DICOM) room is used despite the fact that not references, many of them included the Careposition: radiation free positioning of col- every item in the room is needed for a limators service, because in practice the rooms use of an angiography room, such as Carewatch: acquisition and monitoring of CPT code 36227 (Selective catheter configurable dose area product are configured for the most typical type placement, external carotid artery) and Carefilter: Cu-prefiltration of procedure performed within the room CPT code 37233 (Revascularization, DICOM HIS/RIS and it would not be efficient or realistic endovascular, open or percutaneous, Control room interface to remove items from a room when a tibial/peroneal artery, unilateral, each Injector, Provis less typical service is needed. For the additional vessel). Therefore, we agreed Shields, lower body and mavig specific case of the Provis Injector that the use of the angiography room in Leonardo software equipment, commenters stated it could these procedures, or at least some of its Fujitsu-Siemens high performance computers not be used elsewhere and there was no Color monitors component parts, might be warranted. Singo modules for dynamic replay and full way to create a separate angiography Comment on the CY 2016 PFS final format images room for nonvascular procedures that rule with comment period: A Prepared for internal networking and Sie- did not require the injector. commenter stated that the substitution mens remote servicing, both hardware and Commenters did not generally agree of the fluoroscopic room for the software with the CMS proposal to price all of angiography room was clinically the components of the angiography unjustified. The commenter stated that We included all of the above room at $0.00 pending invoices from the the angiography room was needed for components except the Provis Injector, public regarding their individual cost. these procedures to carry out 3-axis as commenters indicated that its use Commenters stated that the resource rotational imaging (so as to avoid rolling would not be typical for these cost of the angiography room the patient), ensure sterility, and avoid procedures. We welcomed additional components was clearly not $0.00, since unacceptable radiation exposure to comments regarding if these or other the equipment in total costs over $1.3 physicians, their staff, and their components were typically used in million. Commenters stated that it was

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not realistic to submit 21 separate 0-day to no global period, to be (24) Cystourethroscopy (CPT Code invoices during the 60 day comment consistent with the global period for 52000) period, and furthermore that the CPT code 51784. Additionally, we In the CY 2016 PFS final rule with components of the angiography room proposed to add CPT code 51785 to the comment period, CMS identified CPT are typically not sold separately. list of potentially misvalued codes to code 52000 through the screen for high Response: We appreciate the feedback update the value of the service expenditure services. We stated in the from commenters regarding the considering the change in global period, CY 2017 proposed rule that the RUC- difficulties involved in pricing the and to maintain consistency with CPT recommended work RVU of 1.75 for components for the angiography room. code 51784. CPT code 52000 is higher than the work We have longstanding issues with the Comment: A commenter supported RVUs for all 0-day global codes with 10 equipment rooms as they are currently CMS’ proposal to accept the RUC- minutes of intraservice time and we did constituted, due to our belief that all of recommended work value. The the components of the room may not not believe that the overall intensity of commenter requested that CMS indicate this service was greater than all of the typically be used in performing the any global period changes and requests procedure in question. We continue to other codes. Instead, we proposed that for codes as part of the family when this code compares favorably to CPT believe that these three codes do not CMS initially nominates a code or make use of all of the components of the code 58100 (Endometrial sampling reviews the RUC level of interest (LOI) (biopsy) with or without endocervical angiography room, and we believe that prior to distribution. this code family serves as a clear sampling (biopsy), without cervical example of the problems in relativity Another commenter, while supporting dilation, any method (separate associated with the use of ‘‘rooms’’ as our acceptance of the RUC- procedure)), which has a work RVU of equipment items for a limited set of recommended work RVU for CPT code 1.53, and has identical intraservice time services under the PFS. However, we 51784, did not support adding CPT code and similar total time. Therefore, we agree with the commenters that it is not 51785 to the potentially misvalued code proposed a work RVU of 1.53 for CPT likely that the components of the list as that code was addressed recently code 52000, using a direct crosswalk to angiography room do not have a price. when the new CPT codes were created CPT code 58100. Therefore, while we continue to seek for urodynamic testing procedures. Comment: Commenters requested that invoices for more detailed pricing Response: We appreciate commenters’ CMS finalize the RUC-recommended information, we are restoring the perspectives. We note that CPT code work RVU of 1.75 for this procedure. angiography room (EL011) equipment to 51785 has not been valued since January Commenters stated that the RUC- these three codes, with an equipment 2003, at the same RUC meeting wherein recommended crosswalk codes were a time of 47 minutes for CPT code 50606, CPT code 51784 was valued. We more accurate comparison of physician 62 minutes for CPT code 50705, and 62 encourage stakeholders to submit the work, time, and intensity for procedures minutes for CPT code 50706, in each entire code family when submitting reported with CPT code 52000. case consistent with the equipment time codes for inclusion on the list of Response: The RUC-recommended in CY 2016. We intend to continue to potentially misvalued codes. work RVU of 1.75 is higher than the consider the use of equipment ‘‘rooms’’ Comment: One commenter stated that work RVUs associated with all other more broadly for future rulemaking. there is no difference in the work value codes with 0-day global periods and 10 After consideration of comments of CPT code 51784 whether it has a 0- minutes of intraservice time, and we received, we are finalizing our work day global period versus an XXX global continue to believe that the work and values for the three Genitourinary codes period, and should not be considered as intensity of this service is similar to as proposed. We are finalizing the potentially misvalued. other CPT codes with 10 minutes of intraservice time. Therefore, we are proposed direct PE inputs as well, with Response: We note that CPT code finalizing a work RVU of 1.53 for CPT the changes to the angiography room as 51784 was identified as potentially code 52000. detailed above. misvalued through a screen of high (23) Electromyography Studies (CPT expenditure services by specialty. In the (25) Biopsy of Prostate (CPT Code Code 51784) standard process of code valuation, 55700) We identified CPT code 51784 as CMS decided to change the global In the CY 2016 PFS final rule with potentially misvalued through a screen period to XXX, indicating no global comment period, CMS identified CPT of high expenditure services by period, so that the code is more closely code 55700 as potentially misvalued specialty. This family also includes CPT aligned with other similar services. based on the high expenditure by code 51785 (Needle electromyography Comment: One commenter did not specialty screen. studies (EMG) of anal or urethral agree that CMS should accept the RUC- The RUC subsequently reviewed this sphincter, any technique) but was not recommended work values, stating that code for physician work and practice included in this survey. Both services the RUC-recommended work RVU expense and recommended a work RVU have 0-day global periods. The RUC underestimates the work involved in of 2.50 based on the 25th percentile of recommended a work RVU of 0.75 for furnishing this service. the survey. We believed the RUC- CPT code 51784. We believe that this Response: We remind commenters recommended work RVU overestimates service is more accurately valued and stakeholders that disagree with the work involved in furnishing this without a global period, since that is CMS values, including those based on service given the reduction in total more consistent with other diagnostic RUC recommendations, that in addition service time; specifically, the reduction services, and specifically, with all the to submitting comments on our in preservice and postservice times. The other diagnostic electromyography proposed rules, they may also nominate RUC recommendation also appears services. We proposed to eliminate the codes as potentially misvalued through overvalued when compared to similar 0- global period and proposed the RUC- the public nomination process. After day global services with 15 minutes of recommended work RVU of 0.75 for CY consideration of comments, we are intraservice time and comparable total 2017. We also proposed to change the finalizing the work and global period times. To develop a proposed work global period for CPT code 51785 from changes as proposed. RVU, we crosswalked the work RVUs

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for this code from CPT code 69801 an open procedure, such as CPT code improved if the CPT Editorial Panel (Labyrinthotomy, with perfusion of 55840. Commenters stated that were to consider further revisions to this vestibuloactive drug(s), transcanal), developing the skill necessary to code to describe the two cases of noting similar levels of intensity, similar perform a minimally invasive laparoscopic radical prostatectomy: total times, and identical intraservice laparoscopic surgery requires a greater With and without robotic assistance. times. Therefore, we proposed a work degree of experience and specialized Comment on the CY 2016 PFS final RVU of 2.06 for CPT code 55700. training than that required to perform an rule with comment period: One Comments: A few commenters, open prostatectomy. Commenters commenter stated that the application of including the RUC, noted the RUC indicated that this level of practitioner the phase-in transition for facility-only compared CPT code 55700 to other 0- skill should be reflected in the work codes like CPT code 55866 would have day global services with 15 minutes of RVU for the procedure, as intensity is a particularly egregious impact in the intraservice time and stated that the based in part upon skill, mental effort, second year of the transition. The RUC-recommended value was and psychological stress. commenter urged CMS to ensure that its appropriate. The RUC noted that the Response in the CY 2017 PFS implementation of the phase-in overall work of the surveyed code was proposed rule: We agreed with the transition does not undermine the similar to services: CPT code 93503 commenters that skill and technique, as protections created by the statute. (Insertion and placement of flow well as mental effort and psychological Response in the CY 2017 PFS directed catheter (eg, Swan-Ganz) for stress on the part of the practitioner proposed rule: Please see sections II.G monitoring purposes) (work RVU = 2.91, contribute to the overall intensity of the and II.H for a discussion of the phase- intraservice time of 15 minutes) and furnishing a given service, and in transition and its implementation in CPT code 36556 (Insertion of non- therefore, are one of the two its second year. tunneled centrally inserted central components in determining code-level Comment on the CY 2016 PFS final venous catheter; age 5 years or older) work RVUs. However, we did not rule with comment period: Several (work RVU = 2.50, intraservice time of believe that relative increases in commenters requested that CMS refer 15 minutes). The RUC determined that requisite skill or technique can be CPT code 55866 to the refinement panel these services required the same intra- considered alone. Although the for review. At the refinement panel, the service time, comparable physician development of new technology (such presenters brought up new evidence in work and intensity and recommended as robotic assistance) may create a the form of a study published in 2016 CMS accept the RUC-recommended greater burden of knowledge on the part describing discharge data for radical work RVU of 2.50. Additionally, the of the practitioner, it can also make laparoscopic prostatectomies. The RUC continued to urge specialty procedures faster, safer, and easier to presenters stated that there were many societies to submit invoices for new perform. This means that there may be more people included in this study as equipment. reductions in time for such a procedure opposed to the 30 respondents in the Response: We appreciate additional (which is the other component of the survey data, and that on average the information offered by the commenters. work RVU), but also that the mental robotic procedure took 90 minutes After consideration of comments effort and psychological stress for a longer than the open procedure. The received, we agree with the additional given procedure may be mitigated by additional time needed to perform the information provided by commenters the improvements in safety. Therefore, procedure, as indicated by this new and are finalizing the RUC- we did not agree that a newer procedure study’s results, was presented as a new recommended work RVU of 2.50. that includes additional technology and rationale as to why CMS should accept requires greater training would the RUC-recommended work RVU. (26) Laparoscopic Radical Prostatectomy Response in the CY 2017 PFS (CPT Code 55866) inherently be valued at a higher rate than an older and potentially more proposed rule: CPT code 55866 was In the CY 2016 PFS final rule with invasive procedure. referred to the CY 2016 Multi-Specialty comment period, we established an Comment on the CY 2016 PFS final Refinement Panel per the request of interim final work RVU of 21.36 for CPT rule with comment period: A commenters. The outcome of the code 55866 based on a direct crosswalk commenter stated that CPT code 55866 refinement panel was a median work to CPT code 55840 (Prostatectomy, describes two very different procedures RVU of 26.80, the same value as the retropubic radical, with or without in one code. The descriptor for the code RUC recommended in the previous nerve sparing). We stated that we states ‘‘includes robotic assistance when rulemaking cycle. After consideration of believed these codes were medically performed’’, and the procedure is the comments and the results of the similar procedures with nearly identical performed differently depending on refinement panel, we proposed for CY time values, and we did not believe that whether or not the robotic assistance is 2017 to maintain the interim final work the difference in intensity between CPT included. The commenter indicated that RVU of 21.36 for CPT code 55866. We code 55840 and CPT code 55866 was the vast majority of radical were interested in the results of the significant enough to warrant the RUC- prostatectomies are performed with the study mentioned at the refinement recommended difference of 5.50 work robot, and although the outcomes are panel, and we stated that we would RVUs. We also compared CPT code the same in both cases, the procedures consider incorporating this data into the 55866 to the work RVU of 25.18 for CPT are completely different. valuation of this code, including, if code 55845, and stated our belief that, Response in the CY 2017 PFS appropriate, adjustments to the work in general, a laparoscopic procedure proposed rule: We agreed with the times used in PFS ratesetting. We also would not require greater resources than commenter that the descriptor includes solicited that the study be submitted an open procedure. the possibility for confusion, especially through the public comment process so Comment on the CY 2016 PFS final on the part of the survey respondents. that we could allow it proper rule with comment period: Several Valuing this code based on the typical consideration along with other commenters disagreed with the case is difficult when the procedure information submitted by the public, statement that a laparoscopic procedure, differs depending on the inclusion or rather than using the results of a single such as CPT code 55866, would exclusion of robotic assistance. We study to propose valuations. We were generally require fewer resources than suggested that valuation might be also curious about the time values

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regarding the duration of CPT code robotic approach took on average 90 (27) Hysteroscopy (CPT Codes 58555, 55866. One of the members of the minutes longer than an open radical 58558, 58559, 58560, 58561, 58562, and refinement panel stated that on average prostatectomy. Commenters noted how 58563) the robotic procedure took 90 minutes this contrasted to the RUC survey data During CY 2016 PFS rulemaking, we longer than the open procedure. This that had only 32 respondents and identified CPT code 58558 as a was not what was indicated by the recommended an intraservice time potentially misvalued code via the high survey data from the RUC equal to an open radical prostatectomy expenditure specialty screen. CPT codes recommendations, which had the two (180 minutes). The commenters 58559–58563 were also included in the procedures valued at virtually identical presented the study data in favor of RUC’s January 2016 review of this times (same intraservice time, 6 minutes demonstrating how the robotic approach family of codes. difference total time). We therefore to radical prostatectomy detailed in CPT For CPT code 58555, the RUC solicited comment on whether the times code 55866 takes significantly more recommended a work RVU of 3.07. We included in this study were more proposed that the 25th percentile survey accurate than the time reflected in the time to perform than the open approach detailed in the CMS crosswalk code result, a work RVU of 2.65, accurately RUC surveys. reflects the resources involved in The following is a summary of the 55840. Commenters recommended that furnishing this service. We stated that comments we received regarding our CMS adopt the RUC-recommended this value is bracketed by two crosswalk proposed valuation of CPT code 55866: work RVU of 26.80 based on this new Comment: One commenter agreed that clinical evidence contained in the codes, CPT code 43191 (Esophagoscopy, the code descriptor for CPT code 55866 study. rigid, transoral; diagnostic, including might have caused confusion by the collection of specimen(s) by brushing or Response: We appreciate the washing when performed (separate RUC survey respondents. The submission of this additional clinical commenter stated that they were procedure)), which has a work RVU of information from the commenters. We 2.49, and CPT code 31295 (Nasal/sinus encouraged by the CMS comments that have had longstanding interest in using the valuation might be improved if the endoscopy, surgical; with dilation of robust data sources regarding the CPT Editorial Panel were to consider maxillary sinus ostium (for example, resource costs of PFS services, and we further revisions to this code to describe balloon dilation), transnasal or via a laparoscopic radical prostatectomy believe that the use of such additional canine fossa), which has a work RVU of with and without robotic assistance. outside data sources can improve the 2.70. CPT codes 43191 and 31295 have The commenter requested a strong accuracy of the valuation of services. identical intraservice times and similar statement from CMS urging the CPT However, we do note that the cited total times when compared with CPT Editorial Panel to create two unique study was not specifically designed to code 58555. codes: One for laparoscopic radical measure intraoperative times and did For CPT code 58558, the RUC prostatectomy and one for robotic not use the same ‘‘skin to skin’’ recommended a work RVU of 4.37. radical prostatectomy. definition of intraservice time typically However, we believed that a direct Response: We believe that there are used in the development of times crosswalk from CPT code 36221 (Non- potential problems with CPT code included in PFS ratesetting. selective catheter placement, thoracic aorta, with angiography of the 55866 as it is currently described and In this case of the particular comment, extracranial carotid, vertebral, and/or with the corresponding RUC we note the potential logical dissonance recommendation. Commenters intracranial vessels, unilateral or of the commenter urging us to adopt the bilateral, and all associated radiological presented data suggesting that there are RUC-recommended work value derived significant differences between the supervision and interpretation, includes from the RUC survey by citing robotic and non-robotic versions of the angiography of the cervicocerebral arch, alternative data that calls into question procedure in the length of time required when performed), which has a work to perform the operation. However, the the accuracy of the time data from the RVU of 4.17, and identical intraservice same data also suggests that the non- same RUC survey. In other words, we time, and similar total time, more robotic version of the laparoscopic are troubled with the idea that we accurately reflects the time and radical prostatectomy has become should consider survey data as valid for intensity of furnishing this service. Our comparatively rare. Given the work while rejecting its validity for proposed work RVU was additionally information presented by commenters, time, given that time is one of the two supported by using an increment we believe that valuation might be elements of overall work. between this code and the base code for improved with further revisions to this Despite these concerns, we agree that this family, CPT code 58555. The code. However, we note that we do not the study presents additional data increment between the RUC- direct the work of the CPT Editorial indicating that there is a significant recommended values for these two Panel, and we also note the comparative difference between the open and codes is 1.3. That increment added to rarity of the non-robotic version of the robotic-assisted forms of laparoscopic the proposed work RVU of 2.65 for the procedure. radical prostatectomy, and that the base code, CPT code 58555, results in a Comment: Several commenters robotic form described by CPT code work RVU of 3.95. Therefore, we referenced a study entitled ‘‘Robot- 55866 likely takes a longer time to proposed a work RVU of 4.17 RVUs for assisted versus Open Radical perform. Based on this presentation of CPT code 58558. Prostatectomy: A Contemporary For CPT code 58559, the RUC additional clinical evidence, we agree Analysis of an All-payer Discharge recommended a work RVU of 5.54. with the commenters that the Database’’ by J.L. Leow, S.L. Chang, and However, we believed that a direct recommended work RVU of 26.80 is a colleagues. This study was published in crosswalk from CPT code 52315 February 2016, and it detailed how more appropriate value for this (Cystourethroscopy, with removal of university investigators analyzed more procedure. foreign body, calculus, or ureteral stent than 600,000 men undergoing radical After consideration of comments from urethra or bladder (separate prostatectomy in the United States from received, we are finalizing a work RVU procedure); complicated), which has a 2003–2013, which showed that the of 26.80 for CPT code 55866. work RVU of 5.20, a similar intraservice

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time, and similar total time as compared surface area, or 1% of body area of include the sterilization tray from the with CPT code 58559 more accurately infants and children), which has a work hysteroscopic resection system because reflects the time and intensity of RVU of 4.00 and which has identical we believe this tray has generally been furnishing this service. This proposed intraservice time and similar total time, characterized as an indirect practice value was additionally supported by more accurately reflects the time and expense. For the hysteroscopic resection using an increment between CPT code intensity of furnishing this service. The system, we proposed to include the 58559 and the base code for this family, RUC also used this code as one of its hysteroscopic tissue remover ($18,375), CPT code 58555. The increment supporting codes for its the sheath ($1,097.25), and the between the RUC recommended values recommendation. This value is calibration device ($300), and created a for the two codes is 2.47. That additionally supported by using an new equipment item code, priced at increment added to the proposed value increment between CPT code 58562 and $19,857.50 in the proposed direct PE for the base code, CPT code 58555, the base code for this family, CPT code input database. We did not propose to would result in a work RVU of 5.12. 58555. The increment between the RUC include the calibration device since the Therefore, we proposed a work RVU of recommended values for the two codes submitted price was not documented 5.20 for CPT code 58559. is 1.10. That increment added to the with a paid invoice. For CPT code 58560, the RUC proposed value for the base code, CPT Comment: Commenters, including the recommended a work RVU of 6.15. We code 58555, results in a work RVU of RUC, disagreed with CMS’ proposed stated in the proposed rule that we 3.75. Therefore, we proposed a work refinements to the work RVUs for these believe that a direct crosswalk from CPT RVU of 4.00 for CPT code 58562. procedures, and requested that CMS code 52351 (Cystourethroscopy, with For CPT code 58563, the RUC finalize the RUC-recommended work ureteroscopy and/or pyeloscopy; recommended a work RVU of 4.62. values for these codes. Commenters diagnostic), which has a work RVU of However, we believed that a direct suggested that these procedures are 5.75 and which has more intraservice crosswalk of the work RVUs for CPT more complex in cases where it is more time and very similar total time, more code 33962 (Extracorporeal membrane difficult to find and feed the scopes accurately reflects the time and oxygenation (ECMO)/extracorporeal life through the cervix. Commenters intensity of furnishing this service. Our support (ECLS) provided by physician; suggested that it appeared as though proposal further supported this value by reposition peripheral (arterial and/or CMS used a time to work ratio to value using an increment between CPT code venous) cannula(e), open, 6 years and these services, stating further that, for 58560 and the base code for this family, older (includes fluoroscopic guidance, example, CPT code 58555 requires a CPT code 58555. We stated that the when performed)), which has a work forced dilation of a natural orifice, very increment between the RUC RVU of 4.47 and that has identical small in size and can be difficult to recommended values for the two codes intraservice time and similar total time, identify in a post-menopausal patient or is 3.08. That increment added to the more accurately reflects the resources a patient with prior cervical surgery. proposed value for the base code, CPT involved in furnishing this service. This Commenters suggested that the CMS code 58555, would result in a work RVU value is additionally supported by using crosswalk codes are for a natural orifice of 5.73. Therefore, we proposed a work an increment between CPT code 58563 that might not require any dilation or RVU of 5.75 for CPT code 58560. and the base code for this family, CPT only a 10% dilation, and the orifice is For CPT code 58561, the RUC code 58555. The increment between the consistently the same with little recommended a work RVU of 7.00. We RUC recommended values for the two variation among patients. stated in the proposed rule that we codes is 1.55. That increment added to Response: While we appreciate the believe that a direct crosswalk from CPT the proposed value for the base code, commenters’ feedback, we do not code 35475 (Transluminal balloon CPT code 58555), results in a work RVU consider forced or difficult dilation as angioplasty, percutaneous; of 4.20. We note that CPT code 58563 described by the commenter to be brachiocephalic trunk or branches, each has the same instraservice time and the typical based on the RUC’s clinical vessel), which has a work RVU of 6.60 same total time as CPT code 58558; vignette and that the difficulty of forced and which has similar intraservice and however, we agreed that the intensity dilation at the time of surgery can often total times, more accurately reflected would be slightly higher for this service. be offset by preoperative cervical the time and intensity of furnishing this Therefore, we proposed a work RVU of ripening. Therefore, we are finalizing service. We also noted that our proposal 4.47 for CPT code 58562. the following work RVUs for each code was further supported by using an The RUC submitted invoices for two in this family. increment between CPT code 58561 and new equipment items used in furnishing • CPT code 58555, 2.65 work RVUs; the base code for this family, CPT code CPT code 58558, the hysteroscopic fluid • CPT code 58558, 4.17 work RVUs; 58555. The increment between the RUC management system and the • CPT code 58559, 5.20 work RVUs; recommended values for the two codes hysteroscopic resection system. We • CPT code 58560, 5.75 work RVUs; is 3.93. That increment added to the proposed to use these invoice prices for • CPT code 58561, 6.60 work RVUs; proposed value for the base code, CPT the hysteroscopic fluid management • CPT code 58562, 4.00 work RVUs; code 58555, would result in a work RVU system, which totaled $14,698.38. The and of 6.58. Therefore, we proposed a work hysteroscopic resection system included • CPT code 58563, 4.47 work RVUs. RVU of 6.60 for CPT code 58561. the price of the hysteroscope, as well as Comment: Regarding the direct PE For CPT code 58562, the RUC other items necessary for tissue removal. inputs for CPT code 58558, one recommended a work RVU of 4.17. However, we generally price commenter requested that CMS add a However, we believed that a direct endoscopes separately and not as a part procedure kit and update the prices for crosswalk of the work RVUs for CPT of a system. To maintain consistency, these supplies to reflect the cost of code 15277 (Application of skin we proposed not to include the providing this procedure in the substitute graft to face, scalp, eyelids, hysteroscope from the Resection physician office setting. The commenter mouth, neck, ears, orbits, genitalia, System. Instead, we proposed to update also submitted invoices related to other hands, feet, and/or multiple digits, total the equipment item ‘‘endoscope, rigid, direct PE inputs for this code, including wound surface area greater than or equal hysteroscopy’’ (ES009) with the invoice invoices for the incisor blade and the to 100 sq cm; first 100 sq cm wound price, $6,207.50. We did not propose to procedure kit, which the commenter

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indicated includes inflow tubing, unilateral, initial vessel; with was presented at the refinement panel outflow tubing, and the non-sterile transluminal stent placement(s), that indicated that these comparisons components of jumper cables and a includes angioplasty within the same are not accurate. Therefore, for CY 2017, tissue trap. vessel, when performed), due to similar we proposed work RVUs of 15.00 for Response: We appreciate the feedback intensity and intraservice time. We CPT code 61645, 10.00 for CPT code we received regarding the direct PE valued CPT code 61651 based on a 61650, and 4.25 for CPT code 61651. We inputs for CPT code 58558. We agree crosswalk to CPT code 37223 also proposed time inputs based on our with the addition of the hysteroscopic (revascularization, endovascular, open refinements of the RUC procedure kit and are creating a new or percutaneous, iliac artery, each recommendations, including removing supply item ‘‘hysteroscopic fluid additional ipsilateral iliac vessel; with the time associated with a hospital management tubing set’’ using a single transluminal stent placement(s), inpatient visit (CPT code 99233) from invoice price of $320. Additionally, we includes angioplasty within the same the intraservice work time, and adding note that we inadvertently did not vessel, when performed (list separately 30 minutes to the immediate postservice remove the existing direct PE inputs in addition to the code for primary time for both CPT codes 61645 and related to suction, which we proposed procedure)), due to similar intraservice 61650. to replace with the hysteroscopic fluid time and intensity. We do not believe that 0-day global management system. Therefore, we are Both CPT codes 61645 and 61650 codes should include post-operative removing direct PE inputs for the included postservice work time visits; rather, if global codes require following items: associated with a level 3 inpatient • post-operative visits, they are more Supply item SD009: Canister, hospital visit. In the CY 2016 PFS final appropriately assigned 10- or 90-day suction; rule with comment period, we stated global periods based on our current • Supply item SD031: Catheter, that we believe that for the typical criteria. Our policy has been to remove suction; and patient, these services would be • Equipment item EQ235: Suction the visit from the post-operative period considered hospital outpatient services, and the associated minutes from the machine (Gomco). not inpatient services. As a result, the The commenter also included an total time while adding 30 minutes to intraservice time of the hospital the immediate postservice period additional invoice for the incision observation care service was valued in instrument. Based on this new without necessarily making an the immediate postservice time. We adjustment to the work RVU (see the CY information, we are renaming this new refined the work time for CPT code supply item, ‘‘hysteroscopic tissue 2010 PFS proposed rule, 74 FR 33557; 61645 by removing 55 minutes of work also see the CY 2011 PFS proposed rule, removal device,’’ with a final price of time associated with CPT code 99233, $629.00, which is the simple average of 75 FR 40072). We solicited comment on and added 30 minutes of time to the the inclusion of post-operative visits in the two invoice prices we have received immediate postservice time. Therefore, valuation of codes with 0-day global for this supply item ($599 and $659 the total time for CPT code 61645 was periods. Both CPT codes 61645 and respectively). Additionally, we note that reduced to 241 minutes and the 61650 are assigned 0-day global periods, our proposed summary price for the immediate postservice time increased to and the refinements we proposed hysteroscopic resection system was 83 minutes. We also removed the reflected changes to more appropriately added incorrectly. The correct price is inpatient visit from CPT code 61650, value these codes with 0-day global $19,772.25. We are also modifying the which reduced the total time to 206 periods. equipment title to ensure clarity of minutes and increased the postservice items included in the hysteroscopic time to 75 minutes. The following is a summary of the resection system (control unit, Comment on the CY 2016 PFS final comments we received regarding our footpiece, handpiece, sheath and rule with comment period: Commenters proposed valuations for the intracranial calibration device). disagreed with our categorization of endovascular intervention family: these codes as typically outpatient. Comment: Commenters, including the (28) Intracranial Endovascular Commenters stated that according to RUC, requested that CMS finalize the Intervention (CPT Codes 61645, 61650, Medicare claims data, the predecessor RUC-recommended work RVUs for CPT and 61651) codes were performed primarily on an codes 61645, 61650 and 61651. The For CY 2016, we established an inpatient basis. Additionally, RUC suggested that evaluating the interim final work RVU of 15.00 for CPT commenters pointed out that the new actual physician work performed in the code 61645, 10.00 for CPT code 61650 codes would typically be performed on inpatient setting is more accurate than and 4.25 for CPT code 61651. The RUC- acute stroke patients. Commenters also applying a crosswalk to a CPT code that recommended values for CPT codes said as the new codes are inpatient- is performed predominantly in the 61645, 61650 and 61651 were 17.00, only, the CMS reductions in work and outpatient setting. As examples, the 12.00 and 5.50, respectively. We valued time based on the assumption of RUC noted that CPT code 61645 would CPT code 61645 by applying the ratio outpatient status are flawed and not be performed in the outpatient between the RUC-recommended suggested we accept the RUC- setting, and CPT codes 61650 and 61651 reference code, CPT code 37231 recommended values. Commenters also would be performed in the intensive (revascularization, endovascular, open requested that these codes be referred to care unit. For CPT codes 61645 and or percutaneous, tibial, peroneal artery, the refinement panel. 61650, commenters also expressed unilateral, initial vessel; with Response in the CY 2017 PFS concern about CMS’ proposed transluminal stent placement(s) and proposed rule: For CY 2016, we valued refinements to remove the time atherectomy, includes angioplasty CPT codes 61645, 61650, and 61651 associated with a postservice visit from within the same vessel, when based on comparisons to CPT codes each code and subsequently adding 30 performed), to the work and time for 37231, 37221, and 37223, respectively. minutes to the immediate postservice CPT code 61645. We valued CPT code We continue to believe that these period for each of these codes. The RUC 61650 based on a crosswalk to CPT code crosswalks are appropriate comparisons suggested that these CMS refinements 37221 (revascularization, endovascular, based on intensity and intraservice time, artificially reduced the total work time open or percutaneous, iliac artery, and because no persuasive information for CPT codes 61645 and 61650.

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Response: We continue to believe that Comment: A few commenters procedures. The RUC agreed that the our crosswalks for each of these codes expressed their support for the proposed intensity of CPT code 62380 was greater, accurately reflect the physician work work values. which offsets the 10 minute difference involved in these procedures due to Response: We appreciate the support in intraservice time between the two similarities in intensity and intraservice from the commenters. codes. The RUC indicated that the time. For example, our proposed work Comment: Several commenters difference in intensity between these RVU of 15.00 for CPT code 61645 would disagreed with the proposed removal of procedures is based on CPT code 62380 be the highest work value among the 10–12mL syringes (SC051) and the involving decompression about neural comparable codes with similar RK epidural needle (SC038) due to the elements and the spinal cord, where the intraservice times. We note that we CMS belief that they are duplicative of opportunity for complications and for identified three CPT codes with similar the supplies in the epidural tray loss of function is high. One commenter intraservice times (CPT codes 33955, (SA064). Commenters stated that indicated that CMS’ proposed work 33956, and 33988) that had higher work although there are three syringes listed RVU would fall below the minimum RVUs than our proposed work RVU of in the epidural tray, none of the syringes survey results. 15.00, but these three CPT codes are in the tray are the 10–12mL syringe. In A few commenters expressed used to report extracorporeal membrane addition, none of the needles currently concerns about the structure of the CPT oxygenation or extracorporeal life listed in the epidural tray (SA064) are code descriptors and RUC- support services (ECMO/ECLS) an epidural needle. As a result, recommended valuations. Commenters procedures, which we do not believe are commenters indicated that there was no suggested that the CPT Editorial Panel comparable to the CPT codes in this reason to replace the epidural tray with and the RUC did not take certain family. its individual components. indications into account such as Regarding physician time for CPT Response: We appreciate this differences between the physician work codes 61645 and 61650, as we discussed clarification from the commenters required for endoscopic tubular in the proposed rule, we do not believe regarding the components that make up microdiscectomy compared to lumbar that 0-day global codes should include the epidural tray. Taking this spinal stenosis decompression and post-operative visits; rather, if global information into account, we are posterior cervical posterior codes require post-operative visits, they restoring the 10–12mL syringes (SC051) laminoforaminotomy. Commenters are more appropriately assigned 10- or and the RK epidural needle (SC038) to indicated that the specialty society 90-day global periods based on our all eight of the codes in this family. survey data was inadequate due to the current criteria. Our policy has been to After consideration of comments inexperience of the survey respondents, remove the visit from the post-operative received, we are finalizing the proposed with others suggesting that the survey period and the associated minutes from work RVUs for the Epidural Injection times were not reflective of some the total time while adding 30 minutes codes. We are also finalizing the practitioners’ experience or patient to the immediate postservice period proposed direct PE inputs, with the complexity. without necessarily making an addition of the 10–12mL syringes and The commenters indicated that the adjustment to the work RVU (see the CY the RK epidural needle detailed above. current RUC recommendations for full endoscopic tubular endoscopic surgery 2010 PFS proposed rule, 74 FR 33557; (30) Endoscopic Decompression of are based on limited experience among also see the CY 2011 PFS proposed rule, Spinal Cord (CPT Code 62380) 75 FR 40072). survey respondents with lumbar Therefore, for CY 2017, we are For CY 2016, the CPT Editorial Panel microdiscectomy, and insufficient finalizing a work RVU of 15.00 for CPT created CPT code 62380 to describe the experience with lumbar spinal stenosis code 61645, a work RVU of 10.00 for endoscopic decompression of neural decompression and posterior cervical CPT code 61650, and a work RVU of elements. The RUC recommended a foraminotomy without fusion and are 4.25 for CPT code 61651. work RVU of 10.47 based on a crosswalk invalid for these indications. to CPT code 47562 (Laparoscopy, Commenters requested that the current (29) Epidural Injections (CPT Codes surgical; cholecystectomy) with a higher CPT codes and valuations for full 62320, 62321, 62322, 62323, 62324, intraservice time than reflected in the endoscopic lumbar spinal stenosis 62325, 62326, and 62327) survey data. Since we believe CPT codes decompression and posterior cervical We proposed the RUC-recommended 62380 and 47562 are similar in foraminotomy without fusion remain work RVU for all eight of the codes in intensity, we believe using the same unchanged until further RUC survey this family. work RVU as the crosswalk code data are examined. Some commenters We proposed to remove the 10–12mL overestimates the work involved in suggested alternative crosswalks syringes (SC051) and the RK epidural furnishing CPT code 62380. Reference including CPT code 61548 needle (SC038) from all eight of the CPT code 49507 (Repair initial inguinal (Hypophysectomy or excision of codes in this family. We stated that hernia, age 5 years or older; incarcerated pituitary tumor, transnasal or these supplies were duplicative, as they or strangulated) has a work RVU of 9.09 transseptal approach, nonstereotactic) are included in the epidural tray and has similar intensity and an with a work RVU of 23.37, CPT code (SA064). As an alternative, we raised identical intraservice time compared to 63030 (Laminotomy the possibility of removing the epidural CPT code 62380. Therefore, we (hemilaminectomy), with tray and replacing it with the individual proposed a work RVU of 9.09 for CPT decompression of nerve root(s), supply components used in each code 62380. including partial facetectomy, procedure; we solicited public comment Comment: Some commenters foraminotomy and/or excision of on either the inclusion of the epidural reiterated that the RUC-recommended herniated intervertebral disc; 1 tray or its individual components for direct crosswalk to CPT code 47562 is interspace, lumbar) with a work RVU of this family of codes. appropriate since this code has a similar 13.18, and CPT code 63056 The following is a summary of the physician time, and the IWPUT of the (Transpedicular approach with comments we received regarding our RUC-recommended work RVU is 0.085, decompression of spinal cord, equina proposed valuation of the Epidural a comparable valuation when compared and/or nerve root(s) (e.g., herniated Injection codes: with other spinal decompression intervertebral disc), single segment;

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lumbar (including transfacet, or lateral and abdominal wall analgesia. For the continuous peripheral nerve blocks that extraforaminal approach) (e.g., far CY 2016 PFS final rule with comment do not include imaging guidance. The lateral herniated intervertebral disc)) period, we established the RUC- commenter stated that the imaging with a work RVU of 21.86. recommended work RVUs of 1.75 and component included in CPT code 64463 Response: As discussed above, 1.10 as interim final for CPT codes was justification for at least the 0.09 commenters raised multiple concerns 64461 and 64462, respectively. For CPT difference between the RUC about the accuracy of the survey results, code 64463, we utilized a direct recommendation and the CMS proposed the RUC’s recommended valuation of crosswalk from three other injection value. The commenter offered CPT code this service, and our subsequent codes (CPT codes 64416 (Injection, 47000 (Biopsy of liver, needle; proposed refinements. Therefore, at this anesthetic agent; brachial plexus, percutaneous), which has identical time, we are finalizing contractor continuous infusion by catheter intraservice time and a work RVU of pricing for CPT code 62380. We note (including catheter placement), 64446 1.90 as a comparator code. that the summary of recommendations (Injection, anesthetic agent; sciatic Response: We appreciate the (SOR) included with the RUC nerve, continuous infusion by catheter additional information offered by the recommendations indicated that the (including catheter placement), and commenters and we agree with the expert panel reviewing the survey data 64449 (Injection, anesthetic agent; commenter’s statement that the image for this procedure believed the survey lumbar plexus, posterior approach, guidance component of this service was median and 25th percentile work RVU continuous infusion by catheter justification for the 0.09 difference were inconsistent with the physician (including catheter placement)), which between the RUC recommendation and work as it related to other major open all had a work RVU of 1.81, as we the CMS proposed value. After review spine procedures. Subsequently, the believed this crosswalk more accurately and consideration of the comments, we RUC recommended a work RVU of reflected the work involved in are finalizing the RUC-recommended 10.47 based on a crosswalk from CPT furnishing this service. work RVUs of 1.75, 1.10 and 1.90 for code 47562 (Laparoscopy, surgical; Comment on the CY 2016 PFS final CPTs code 64461, 64462 and 64463, cholecystectomy). The RUC noted that rule with comment period: We received respectively for CY 2017. procedures reported with CPT code comments from the RUC stating CPT (32) Implantation of Neuroelectrodes 62380 have ten minutes less code 64463 was more comparable to (CPT Codes 64553 and 64555) intraoperative time compared to the CPT code 64483 (Injection(s), anesthetic RUC’s recommended crosswalk from agent and/or steroid, transforaminal The RUC identified CPT codes 64553 CPT code 62380, but suggested that the epidural, with imaging guidance and 64555 as a site of service anomaly physician work of endoscopic (fluoroscopy or CT); lumbar or sacral, during the CY 2016 PFS rulemaking decompression in the small disc single), which has a work RVU of 1.90 cycle. In the Medicare claims data, these interspace near the spinal nerve roots of and requires the same physician work services were typically reported in the the cauda equina is more complex and and time to perform. The RUC nonfacility setting, yet the survey data will require more post-discharge office recommended we accept a work RVU of were predicated on a facility-based work for required imaging to confirm 1.90, which is the 25th percentile of the procedure. We agreed with the RUC that stabilization and for physical therapy survey. Another commenter stated that these two codes should be referred to orders and monitoring. our interim final work RVU for CPT the CPT Editorial Panel to better define We note that based on the RUC’s code 64463 was inappropriate since the services, in particular to investigate utilization crosswalk, services that will imaging guidance is not part of our the possibility of establishing one code be reported in CY 2017 with CPT code comparison codes. The commenter to describe temporary or testing 62380 are currently reported using advocated for us to accept the survey implantation and another code to either CPT code 22899 (Unlisted respondent’s selection of CPT code describe permanent implantation. We procedure, spine) or CPT code 0275T 64483 as the most appropriate maintained the CY 2015 work RVUs and (Percutaneous laminotomy/ comparison code and assign a work direct PE inputs for these two codes on laminectomy (interlaminar approach) RVU of 1.90. an interim basis until receiving updated for decompression of neural elements, Response in the CY 2017 PFS recommendations from the CPT (with or without ligamentous resection, proposed rule: After reviewing and Editorial Panel and the RUC. discectomy, facetectomy and/or considering the comments, we stated we Comment on the CY 2016 PFS final foraminotomy), any method, under continued to believe that CPT codes rule with comment period: A indirect guidance (e.g., fluoroscopic, 64416, 64446, and 64449, all of which commenter requested that CMS allow CT), with or without the use of an have 20 minutes of intraservice time, are practitioners to bill the MACs separately endoscope, single or multiple levels, better crosswalks to CPT code 64463, for a percutaneous electrode kit (SA022) unilateral or bilateral; lumbar)), which which also has 20 minutes of for CPT code 64555. The commenter are both contractor priced for CY 2016. intraservice time and a similar total stated that without allowing for a We welcome feedback from interested time. In contrast, the crosswalk code separate payment for the percutaneous parties and specialty societies regarding recommended by commenters, CPT electrode kit, the payment for the valuation of this service for 64483, only has 15 minutes of procedure would be insufficient to consideration in future rulemaking. intraservice time. Therefore, for CY cover the physician’s costs. 2017 we proposed a work RVU of 1.81 Response in the CY 2017 PFS (31) Paravertebral Block Injection (CPT for CPT code 64463. proposed rule: We agreed that CPT Codes 64461, 64462, and 64463) The following is a summary of the codes 64553 and 64555 as currently In CY 2015, the CPT Editorial Panel comments we received regarding our constructed were potentially misvalued created three new codes to describe proposed valuations for the codes, which is why we maintained the paravertebral block injections at single Paravertebral Block Injection family: CY 2015 work RVUs and direct PE or multiple levels, as well as for Comment: One commenter stated that inputs on an interim basis. We believe continuous infusion for the CMS based its decision on an that the disposable supplies furnished administration of local anesthetic for inappropriate comparison of CPT code incident to the procedure are paid post-operative pain control and thoracic 64463 with codes that describe through the nonfacility PE RVUs. The

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percutaneous electrode kit (SA022) was (230/316) applied to the work RVU change in the work resources involved not previously included in the direct PE (10.73) more accurately reflected the in furnishing the typical service. The inputs for either of these two services, work involved in this procedure. intraservice and total times were and since we proposed to maintain Therefore, we established an interim decreased by approximately 33 percent current direct PE inputs pending final work RVU of 7.81 for CPT code while the elimination of two additional recommendations, we do not 65780. postoperative visits (CPT code 99212) agree that disposable supplies should be Comment on the CY 2016 PFS final alone would reduce the overall work separately payable. We proposed to rule with comment period: The RUC and RVU by at least 24 percent under the maintain the interim final work RVUs other commenters disagreed with our reverse building block method. and direct PE inputs for these two interim final values based on objections However, the RUC-recommended work to our use of time ratios in developing codes, and we looked forward to RVU only represents a 25 percent work RVUs for PFS services. reviewing recommendations regarding reduction relative to the previous value. these procedures again for future Response in the CY 2017 PFS To identify potential work RVUs for this rulemaking. proposed rule: We stated that we Additionally, we were alerted to a appreciate the commenters’ concerns service, we calculated an intraservice discrepancy regarding the times for and responded to these concerns about time ratio between the CY 2015 these codes in the CY 2016 work time our methodology in section II.L of the intraservice time, 15 minutes, and the file. Our proposed CY 2017 work time CY 2017 proposed rule. After review of RUC-recommended intraservice time, 10 file addressed this discrepancy by the comments, we continued to consider minutes, and applied this ratio to the reflecting the RUC recommended times the work RVU of 7.81 to accurately current work RVU of 3.99 to arrive at a of 155 minutes for CPT code 64553 and represent the work involved in CPT work RVU of 2.66 for CPT code 65855, 140 minutes for CPT code 64555. code 65780. We believed this service which we established as interim final The following is a summary of the was similar in overall intensity to CPT for CY 2016. comments we received regarding our code 27766 (Open treatment of medial Comment on the CY 2016 PFS final proposed valuation of the Implantation malleolus fracture, includes internal rule with comment period: A few of Neuroelectrodes codes: fixation, when performed) that has a commenters, including the RUC, Comment: One commenter responded work RVU of 7.89 and a total time that provided explanations as to how the to the CMS request for information more closely approximates that of CPT RUC recommendation had already about whether there was a need for code 65780. accounted for the reduction in separate codes for temporary/testing and In the CY 2017 proposed rule, we physician intraservice time and post- permanent placement for proposed a work RVU of 7.81 for CPT operative visits. Some commenters neuroelectrodes. The commenter stated code 65780. disagreed with CMS’ interim final that it did not support the creation of We did not receive any comments in values based on objections to CMS’ use new separate codes at this time. The response to our proposed valuation on of time ratios in developing work RVUs commenter stressed that the current CPT code 65780; therefore, we are for PFS services. codes account for the work of both finalizing a work RVU of 7.81 as temporary/testing and permanent proposed. Response in the CY 2017 PFS proposed rule: We stated that we placement, making the creation of new (34) Trabeculoplasty by Laser Surgery appreciated the commenters’ concerns codes unwarranted. (CPT Code 65855) Response: We appreciate the regarding the time ratio methodologies submission of this information from the In CY 2015, the RUC identified CPT and responded to those concerns about commenter. We did not receive any code 65855 as potentially misvalued our methodology in section II.H.2 of the comments addressing the proposed through the review of 10-day global CY 2017 proposed rule. After valuation of these codes. services with more than 1.5 considering the explanations provided After consideration of comments, we postoperative visits. The RUC noted that by commenters through public are finalizing the proposed work RVUs the code was changed from a 90-day to comments describing the RUC’s and proposed direct PE inputs for CPT a 10-day global period when it was last methodologies in more detail, we agreed codes 64553 and 64555. valued in 2000. However, the descriptor that the proposed value did not was not updated to reflect that change. (33) Ocular Reconstruction Transplant accurately reflect the physician work CPT code 65855 describes multiple laser involved in furnishing the service. (CPT Code 65780) applications to the trabecular meshwork In CY 2015, the RUC identified CPT through a contact lens to reduce In the CY 2017 proposed rule, we code 65780 as potentially misvalued intraocular pressure. The current proposed the RUC-recommended work through a misvalued code screen for 90- practice is to perform only one RVU value of 3.00 for CPT code 65855. day global services that included more treatment session during a 10-day We did not receive any comments in than 6 office visits. The RUC period and then wait for the effect on response to our proposed valuation on recommended a direct work RVU the intraocular pressure. The descriptor CPT code 65855; therefore, we are crosswalk from CPT code 27829 (Open for CPT code 65855 has been revised finalizing a work RVU of 3.00 as treatment of distal tibiofibular joint and removes the language ‘‘1 or more proposed. (syndesmosis) disruption, includes sessions’’ to clarify this change in Comment: A few commenters stated internal fixation, when performed). practice. their support of CMS’ decision to After examining comparable codes, we The RUC recommended a work RVU determined the RUC-recommended of 3.00 for CPT code 65855. While the propose the RUC-recommended value work RVU of 8.80 for CPT code 65780 RUC-recommended value represents a for CY 2017 and strongly urged us to would likely overstate the work reduction from the CY 2015 work RVU finalize the proposal. involved in the procedure given the of 3.99, we stated that significant Response: Thank you for your change in intraservice and total times reductions in the intraservice time, the comments. For CY 2017 we are compared to the previous values. We total time, and the change in the office finalizing the RUC-recommended work believed that the ratio of the total times visits represent a more significant RVU of 3.00 for CPT code 65855.

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(35) Glaucoma Surgery (CPT Codes commenters’ concerns regarding the 67101 has a higher work RVU than CPT 66170 and 66172) time ratio methodologies and responded code 67105 and according to the The RUC identified CPT codes 66170 to those concerns in section II.H.2 of the surveys, the intraservice and total times and 66172 as potentially misvalued CY 2017 proposed rule (81 FR 46162). remain higher for CPT code 67101. We through a screen for 90-day global codes CPT codes 66170 and 66172 were do not understand why the RUC that included more than six office visits. referred to the CY 2016 multi-specialty believes that CPT code 67105 is more We believed the RUC-recommended refinement panel per commenters’ work than CPT code 67101. Therefore, work RVU of 13.94 for CPT code 66170 request. The outcome of the refinement we did not propose the RUC- did not accurately account for the panel was a median of 13.94 RVUs for recommended work RVU of 3.50 for reductions in time. Specifically, the CPT code 66170 and 14.84 RVUs for CPT code 67105. We did not find CPT code 66172. Due to the new evidence that CPT code 67105 is more survey results indicated reductions of information presented to the refinement intense than CPT code 67101 and 25 percent in intraservice time and 28 panel regarding the level of intensity accordingly, proposed a lower work percent in total time. These reductions required to perform millimeter incisions RVU for CPT code 67105. To value CPT suggested that the RUC-recommended in the eye, we agreed with the code 67105, we used the RVU ratio work RVU for CPT code 66170 assessment of the refinement panel and between CPT codes 67101 and 67105. overstated the work involved in proposed a work RVU of 13.94 for CPT We divided the current work RVU of furnishing the service, since the code 66170 and 14.84 for CPT code 8.53 for CPT code 67105, by the current recommended value only represented a 66172 for CY 2017. work RVU of 8.80 for CPT code 67101 reduction of approximately seven The following is a summary of the and multiplied the quotient by the RUC- percent. We believed that applying the comments we received regarding our recommended work RVU of 3.50 for intraservice time ratio, the ratio between proposed valuations for the Glaucoma CPT code 67101 to arrive at a work RVU the CY 2015 intraservice time, 60 Surgery family: of 3.39. Therefore, for CY 2017, we minutes, and the RUC-recommended Comments: Several commenters proposed a work RVU of 3.39 for CPT intraservice time, 45 minutes, applied to stated their support of CMS’ decision to code 67105. the current work RVU, 15.02, resulted in propose the values recommended by the CPT codes 67107, 67108, 67110, and a more appropriate work RVU of 11.27. refinement panel for CPT codes 66170 67113 were identified through the Therefore, for CY 2016, we established and 66172. Some commenters, Relative Assessment Workgroup process an interim final work RVU of 11.27 for including the RUC, also brought to our under the 90-day global post-operative CPT code 66170. attention discrepancies between our visit screen in CY 2015. The RUC For CPT code 66172, the RUC proposal for these codes in the CY 2017 recommended a work RVU of 16.00 for recommended a work RVU of 14.81. proposed rule and the work RVUs CPT code 67107, which corresponded to After comparing the RUC-recommended posted in Addendum B on the CMS the 25th percentile of the survey. While work RVU for this code to the work Web site. the RUC recommendation represented a RVU for similar codes (for example, CPT Response: For CY 2017, we are five percent reduction from the current code 44900 (Incision and drainage of finalizing a work RVU of 13.94 for CPT work RVU of 16.71, we believed the appendiceal abscess, open) and CPT code 66170 and a work RVU of 14.84 for RUC recommendation still overvalued code 52647 (Laser coagulation of CPT code 66172. We appreciate the service given the 15 percent prostate, including control of commenters bringing this issue reduction in intraservice time and 25 postoperative bleeding, complete regarding conflicting information in the percent reduction in total time. (vasectomy, meatotomy, CY 2017 PFS proposed rule preamble We used the intraservice time ratio cystourethroscopy, urethral calibration text and the public use files published between the existing and new time and/or dilation, and internal on the CMS Web site. We have corrected values to identify an interim final work urethrotomy are included if this discrepancy in this final rule and RVU of 14.06. We believed this value performed))), we believed the RUC- the associated public use files. accurately reflected the work involved recommended work RVU of 14.81 in this service and was comparable to (36) Retinal Detachment Repair (CPT overstated the work involved in this other codes that have the same global Codes 67101, 67105, 67107, 67108, procedure. For the same reasons and period and similar intraservice time and 67110, and 67113) following the same valuation total time. For CY 2016, we established methodology utilized above, we applied For CY 2015, the CPT Editorial Panel an interim final work RVU of 14.06 for the intraservice time ratio between the made several changes to CPT codes CPT code 67107. For CPT code 67108, CY 2015 intraservice time and the 67101 and 67105. These changes the RUC recommended a work RVU of survey intraservice time, 60/90, to the include revising the code descriptors to 17.13 based on the 25th percentile of the CY 2015 work RVU of 18.86. This exclude ‘‘diathermy’’ and ‘‘with or survey, which reflected a 25 percent resulted in a work RVU of 12.57 for CPT without drainage of subretinal fluid’’ reduction from the current work RVU. code 66172. Therefore, for CY 2016, we and removing the reference to ‘‘1 or The survey results reflected a 53 percent established an interim final work RVU more sessions.’’ The recommended reduction in intraservice time and a 42 of 12.57 for CPT code 66172. global period also changed from 90 days percent reduction in total time. We Comment on the CY 2016 PFS final to 10 days. For CPT code 67101, we believed the RUC-recommended work rule with comment period: Several proposed the RUC recommended work RVU overestimated the work, given the commenters, including the RUC, RVU of 3.50, which was based on the significant reductions in intraservice objected with our interim final values 25th percentile of the survey. For CPT time and total time and does not based on objections to our use of time code 67105, the RUC recommended a maintain relativity among the codes in ratios in developing work RVUs for PFS work RVU of 3.84 based on the 25th this family. To determine the services. Commenters also requested percentile of the survey. The RUC also appropriate value for this code and CMS refer CPT codes 66170 and 66172 stated that CPT code 67105 was a more maintain relativity within the family, to the refinement panel. intense procedure, and therefore, it we preserved the 1.13 work RVU Response in the CY 2017 PFS should have a higher work RVU than increment recommended by the RUC proposed rule: We acknowledged CPT code 67101. Currently, CPT code between this code and CPT code 67107

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and applied that increment to the refinement panel, we proposed a work established an interim final work RVU interim final work RVU of 14.06 for CPT RVU of 16.00, 17.13, and 10.25 for CPT of 1.78 for CPT code 74713 based on a code 67107. Therefore, we established codes 67107, 67108, and 66110, refinement of the RUC-recommended an interim final work RVU of 15.19 for respectively, for CY 2017. work RVU of 1.85 using the ratio of CPT code 67108. For CPT code 67110, The following is a summary of the work to time for both codes. This the RUC recommended maintaining the comments we received regarding our proposed value also corresponds to the current work RVU of 10.25. To maintain proposed valuations for the Retinal 25th percentile survey result. appropriate relativity with the work Detachment Repair family: Comment on the CY 2016 PFS final RVUs established for the other services Comments: A few commenters, rule with comment period: Commenters within this family, we used the RUC- including the RUC, noted that CPT stated that the work RVU of 1.78 for recommended 5.75 work RVU codes 67101 and 67105 were last valued CPT code 74713 did not reflect the differential between CPT code 67107 by the Harvard study. The RUC stated higher intensity inherent in the and CPT code 67110 to establish the CY that during the Harvard studies, CPT procedure’s typical patient. The 2016 interim final work RVU of 8.31 for code 67101 was valued higher due to commenter explained that the typical CPT code 67110. For CPT code 67113, greater total time. However, now patient is pregnant with twins and has the RUC recommended and we photocoagulation is reported at vastly a higher likelihood of complications established an interim final work RVU higher levels than the cryotherapy related to congenital anomalies, as well of 19.00 based on the 25th percentile of procedure, as it is considered to be a as of ischemic brain injury with twin the survey. more effective treatment. A few gestations. The commenter further Comment on the CY 2016 PFS final commenters stated that given the stated that twin gestations are more rule with comment period: We received changing nature of the service since the difficult to image. Commenters several comments disagreeing with our last valuation, the intensity of CPT code requested that CPT code 74713 be interim final values based on objections 67105 is now greater and urged CMS to referred to the multispecialty refinement to our use of time ratios in developing accept the RUC-recommended values. panel. work RVUs for PFS services. Some For CPT codes 67107, 67108, 67110, Response in the CY 2017 PFS commenters also stated that by using and 67113, several commenters proposed rule: CPT code 74713 was some RUC-recommended increments supported CMS’ decision to propose the referred to the CY 2016 multispecialty and rejecting others, we have not only values recommended by the refinement refinement panel. After considering the established inconsistencies within the panel and urged CMS to finalize these comments and the results of the family of codes, but potentially opened proposed values. A few commenters, refinement panel, we agreed with up anomalies across a wide range of including the RUC, brought to our commenters that an RVU of 1.78 services. The RUC also expressed attention discrepancies between our underestimated the work for CPT code disagreement with using the proposal for these codes and the work 74713. recommended work RVU increments RVUs posted in Addendum B on the In the CY 2017 proposed rule, we without using the recommended work CMS Web site. proposed a work RVU of 1.85 for the RVU. Some commenters also stated the Response: We note that, according to service for CY 2017. new IWPUT values for these three the surveys, the intraservice and total We did not receive any comments in services are inappropriately low and times were significantly higher for CPT response to our proposed valuation on pointed to the derived per minute code 67101 and note the specialty CPT code 74713; therefore, we are intensity of 0.064 for CPT code 67110 as societies recommended a higher work finalizing the proposed work RVU. particularly problematic. RVU for CPT code 67101 prior to the (38) Abdominal Aortic Ultrasound Response in the CY 2017 PFS RUC meeting. Although commenters Screening (CPT Code 76706) proposed rule: We disagreed with the state that photocoagulation (CPT code statement about inconsistencies as the 67105) is typically billed more For CY 2017, the CPT Editorial Panel codes in this family are valued relative frequently than diathermy (CPT code created a new code, CPT code 76706, to to one another based on the times and 67101), we do not believe the utilization describe abdominal aortic ultrasound level of physician work required for rate of a service in and of itself is reason screening, currently described by each code. enough to warrant an increase in RVUs. HCPCS code G0389. The specialties that We also stated that generally we do Therefore, for CY 2017, we are finalizing surveyed CPT code 76706 for the RUC not agree that a low IWPUT itself a work RVU of 3.50 and 3.39 for CPT were vascular surgery and radiology, indicates overall misvaluation as the codes 67101 and 67105, respectively. and the direct PE inputs recommended validity of the IWPUT as a measure of We appreciate commenters bringing by the RUC included an ultrasound intensity depends on the accuracy of the to our attention the issue regarding room. Based on an analysis of Medicare assumptions regarding the number, conflicting information in the CY 2017 claims data, the dominant specialties level, and work RVUs attributable to PFS proposed rule preamble text and furnishing the service are family visits for services in the post-operative the public use files published on the practice and internal medicine. We global period for individual services. CMS Web site. We have corrected this believe that these specialties may more We provided an example where a discrepancy in this final rule and the typically use a portable ultrasound service with an unrealistic number or public use files. device rather than an ultrasound room. level of postoperative visits may have a For CY 2017, we are finalizing a work Therefore, we proposed to accept the very low derived intensity for the intra- RVU of 16.00, 17.13, 10.25 and 19.00 for RUC-recommended work RVU of 0.55, service time. CPT codes 67107, 67108, CPT codes 67107, 67108, 66110 and and the RUC-recommended PE inputs and 67110 were referred to the CY 2016 67113, respectively, in agreement with for this service, but we solicited multispecialty refinement panel per the refinement panel recommendations. comment regarding whether or not it commenters’ request. The outcome of would be more accurate to substitute a the refinement panel was a median (37) Fetal MRI (74712 and 74713) portable ultrasound device or possibly a work RVU of 16.00, 17.13, and 10.25, For CY 2016, we established the RUC- hand-held device for an ultrasound respectively. After consideration of the recommended work RVU of 3.00 as room for CPT code 76706. We note that comments and the results of the interim final for CPT code 74712. We while the phase-in of significant

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reductions in RVUs ordinarily would rulemaking. While the specialty mix of understanding that they would be not apply to new codes, we believe that the practitioners furnishing services can classified as add-on codes. it would be appropriate to consider this be helpful in identifying typical PE Comment: Many commenters change from a G-code to a CPT code to inputs, we continue to seek definitive disagreed with the proposed work RVU be fundamentally similar to an editorial information regarding the most of 0.38 for CPT codes 77002 and 77003. coding change since the service is not appropriate PE inputs for this code. For Commenters stated that these two codes described differently, and therefore, we CY 2017, we are finalizing the RUC- should not share the same work RVU as proposed to apply the phase-in to this recommended work and PE inputs, as CPT code 77001, on the basis that the service by comparing the previous value proposed. physician work, intensity and of the G-code to the value for the new complexity of codes 77002 and 77003 (39) Fluoroscopic Guidance (CPT Codes CPT code. are greater than the first code in the Comment: One commenter stated that 77001, 77002, and 77003) family. Commenters stated that the this service should be furnished by a In the CY 2015 PFS final rule with intensity and complexity increases in physician or surgeon that specializes in comment period, CMS indicated that parts of the body where there are vascular disease. The commenter noted while CPT codes 77002 and 77003 had additional anatomy considerations, such that CMS should assign inputs based on been previously classified as stand- as superficial and deep structures to which specialties would more alone codes without global periods, we consider with CPT code 77002, as well appropriately furnish a given service. believe their vignettes and CPT Manual as additional neuro and spinal Another commenter disagreed with our parentheticals are consistent with an structures to consider when performing statement in the CY 2017 proposed rule add-on code as has been established for CPT code 77003. One commenter that the dominant specialties furnishing CPT code 77001. Therefore, the global suggested that there was clinical data this service are family practice and periods for CPT codes 77002 and 77003 indicating that CPT codes 77002 and internal medicine. The commenter now reflect an add-on code global 77003 take longer to perform than CPT stated that these specialties are more period with modifications to the code 77001, in contradiction of the RUC likely to make use of a portable vignettes and parentheticals. survey data that assigned all three codes ultrasound device rather than an For CPT code 77001, we proposed the identical time values. The commenter ultrasound room. One commenter says RUC-recommended work RVU of 0.38. stated that this was likely due to the that this service is underutilized, and We stated that the RUC-recommended greater complexity and procedural CMS should implement policies which work RVUs for CPT codes 77002 and variability of the latter two codes. support screening. 77003 did not appear to account for the Another commenter recognized that Response: We appreciate the significant decrease in total times for these codes describe similar services but commenters’ perspectives. We note that, these codes relative to the current total stressed that they do not describe in evaluating codes in the Medicare times. We noted that these three codes identical services, which was especially Physician Fee Schedule (MPFS), we describe remarkably similar services important for CPT code 77003 as it price codes based on the typical service. and have identical intraservice and total pertains to spinal procedure and carries Our review of the Medicare claims data times. Based on the identical times and more risk than the other two codes. indicates that the combined utilization notable similarity for all three of these Response: We recognize the concerns for the technical component of this codes, we proposed a work RVU of 0.38 raised by the commenters in assigning service and the service billed globally is for all three codes. the same work RVU of 0.38 to the three typically billed under the PFS by family The following is a summary of the codes in the Fluoroscopic Guidance practice and internal medicine, which is comments we received regarding our family. We note that even in cases why we solicited comment on whether proposed valuation of the Fluoroscopic where we assign the same work RVU, the PE inputs for this service should be Guidance codes: we do not believe that the services are revised. Comment: A few commenters identical, only that they share the same Comment: A commenter supported disagreed with the change in the global overall resources in work as measured our decision to apply the phase-in to period for CPT codes 77002 and 77003 in RVUs. We also appreciate the this code. to reflect their status as add-on codes. reference to additional clinical data Response: We thank the commenter The commenters stated that this would from one commenter suggesting that for the support. imply that the imaging-related CPT codes 77002 and 77003 take longer Comment: A commenter agreed with preservice and postservice activities to perform than CPT code 77001. We CMS that family practice physicians inherent to these image guidance codes have longstanding concerns about using typically use a portable ultrasound are captured by the base codes with survey data alone for code valuation, device rather than an ultrasound room. which they are reported, which simply and we are always interested in The commenter stated that CMS should is not the case. The commenters investigating additional sources of continue to include an ultrasound room provided an example of how reporting information to assist in this process. We as a direct PE input, unless other of radiation specific information, such encourage future commenters to submit specialties furnishing the service as fluoroscopy time, is not included in this data as part of their public comment indicate that they do not typically make the postservice activities of the base so that it can be used by CMS as part use of an ultrasound room. codes. of the code valuation process. Based on One commenter states that abdominal Response: CPT codes 77002 and the submission of this additional data, aortic aneurysm screenings are 77003 were surveyed under the we believe that the CPT codes 77002 performed on nonportable machines in assumption that they would be and 77003 are more accurately valued at either ambulatory or hospital settings, classified as add-on codes, and the RUC a higher RVU than CPT code 77001. and therefore, an ultrasound room is recommendations for both work RVUs After consideration of comments appropriate. and direct PE inputs reflect this status. received, we are finalizing the RUC- Response: We thank the commenters, We do not believe that it would be recommended work RVUs for all three and we will take this information appropriate to assign these codes a codes in the family, which is an regarding the appropriate PE inputs for different global period after they were increase from the proposed work RVU this service into consideration for future surveyed and valued with the of 0.38 to a work RVU 0.54 for CPT code

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77002 and to 0.60 for CPT code 77003. to price the equipment used in RVUs, but to crosswalk the PE RVUs for We are finalizing the proposed work furnishing these services. the technical component of the current RVU of 0.38 for CPT code 77001 We reviewed these coding changes corresponding G-codes, as we sought without change. and proposed changes to valuation for further pricing information for these these codes for CY 2017. The revised equipment items. (40) Mammography—Computer Aided CPT coding mitigates the need for both Since the publication of the proposed Detection Bundling (CPT Codes 77065, separate G-codes and the CAD add-on rule, we have determined that for 77066 and 77067) codes. Based upon these coding changes several reasons related to claims Section 104 of the Medicare, and the RUC-recommended input processing systems, Medicare claims Medicaid, and SCHIP Benefits values, overall Medicare payment for systems will be unable to process claims Improvement and Protection Act of mammography services would be using CPT codes 77065, 77066, and 2000 (BIPA) (Pub. L. 106–554) required drastically reduced. This is particularly 77067 for CY 2017. However, given the us to create separate codes with higher true for the technical component of parallel structure of these new CPT payment amounts for digital these services, which could possibly be codes, 77065, 77066, and 77067 to mammography compared to film reduced up to 50 percent relative to the mammography, which was the PE RVUs currently used for payment for existing G-codes G0206, G0204, and technology considered to be typical at these services. G0202, we anticipate that the claims the time. In addition, the statute Based on our initial review of the systems will be fully capable of required additional payment to be made recommended inputs for the new codes, processing the appropriate payment when computer-aided detection (CAD) we believed that these changes would policies and prices discussed below for was used. likely result in values more closely CPT codes 77065, 77066, and 77067 by In CY 2002, we began valuing digital related to the relative resources using the existing G-codes. Therefore, mammography services using three G- involved in furnishing these services. for CY 2017, we will operationalize the codes, G0202, G0204, and G0206 to However, we recognized that these new coding rules, including adoption of describe screening mammography, services, particularly the preventive the new code descriptors for CPT codes unilateral diagnostic mammography, screenings, are of particular importance 77065, 77066, and 77067 through use of and bilateral diagnostic mammography, to the Medicare program and the health the three current G-codes. For the respectively. CMS implemented the of Medicare beneficiaries. We were purposes of discussion below, we requirements of BIPA section 104(d)(1), concerned that making drastic changes discuss policies and payment rates for which applied to tests furnished in in coding and payment for these these three codes using the CPT 2001, by using the work RVUs of the services could be disruptive in ways numbers. Therefore, in the preamble parallel CPT codes, but establishing a that could adversely impact beneficiary discussion below, references to the G- fixed PE RVU rather than using PE access to necessary services. We also codes refer to the descriptors, policies, RVUs developed under the standard PE recognized that unlike almost any other and rates for CY 2016 and references to methodology. The fixed amount of PE high-volume PFS service, the RVUs the new CPT codes refer to the 2017 RVUs for these codes has generally used for payment for many years have descriptors, policies and rates that will remained unchanged since not been developed through the be implemented through revisions to the implementation of the G-codes that generally applicable PFS methodologies, current G-codes. We anticipate being specifically described digital imaging. and instead reflect the statutory able to adopt the CPT coding for CY Most mammography services under directive under section 104 of the BIPA. 2018. Medicare have since been billed with Similarly, we recognized that the In addition to soliciting comment on these G-codes when digital changes in both coding and valuation this proposal, we also solicited input on mammography was used, and with CPT are significant changes for those who rates for these services in the codes 77055, 77056, and 77057 when provide these services. Therefore, commercial market to help us film mammography was used. The use instead of proposing to simultaneously understand the potential impacts of any of CAD has been reported with CPT adopt the revised CPT coding and future proposed revisions to PFS codes 77051 and 77052. For CY 2017, drastic reductions in overall payment payment rates. the CPT Editorial Panel deleted CPT rates, we believed it was advisable to codes 77051, 77052, 77055, 77056, propose to adopt the new coding, Finally, we noted that by proposing to 77057 and created three new CPT codes, including the elimination of separate adopt the new coding for CY 2017, any 77065, 77066, and 77067, to describe billing for CAD, for CY 2017 without subsequent significant reduction in mammography services bundled with proposing immediate implementation of RVUs (greater than 20 percent) for the CAD. For CY 2017, the RUC the recommended resource inputs. We codes would be subject to the statutory recommended work RVUs of 0.81 for anticipated that we would consider the phase-in under section 1848(c)(7). CPT code 77065, 1.00 for CPT code recommended inputs, including the To help us examine the resource 77066, and 0.76 for CPT code 77067, as pricing of the required equipment, as inputs for these services, we solicited well as new PE inputs for use in carefully as possible prior to proposing public comment on the list of items developing resource-based PE RVUs revised PE values through subsequent recommended as equipment inputs for based on our standard methodologies. rulemaking. mammography services. We also invited The RUC recommended these inputs Therefore, for CPT codes 77065, commenters to provide any invoices and only one medical specialty society 77066, and 77067, we proposed to that would help with future pricing of provided us with a set of single invoices accept the RUC-recommended work these items.

TABLE 18—RECOMMENDED EQUIPMENT ITEMS FOR MAMMOGRAPHY SERVICES

# Item description Quantity Purpose

1 ...... 2D Selenia Dimensions Mammography 1 Mammography unit and in-room console itself. System.

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TABLE 18—RECOMMENDED EQUIPMENT ITEMS FOR MAMMOGRAPHY SERVICES—Continued

# Item description Quantity Purpose

2 ...... Mammo Accreditation Phantom ...... 1 Required for MQSA. The phantom is currently valued into the existing mammography room. 3 ...... Phantom Case ...... 1 Protects expensive required phantom from damage. 4 ...... Paddle Storage Rack ...... 3 It requires 3 racks to hold and prevent damage to all of the paddles that are part of the typical standard mammography system. 5 ...... Needle Localization Kit ...... 1 Needed for a full functioning mammography room. Allows for the performance of needle localizations. Input is not separately in the PE for the mammography guided procedure codes, 19281–19282, as a fully functioning mammography room is needed for those procedures. 6 ...... Advanced Workflow Manager System 1 Workflow system connecting mammography room and workstations. 7 ...... Cenova 2D Tower System ...... 1 CAD server, and also used for post-processing. 8 ...... Image Checker CAD (9.4) License for 1 License required for using CAD. This is a one-time fee. One FFDM. 9 ...... Film Digitizing System ( ...... 1 Digitizes analog films to digital for comparison purposes. 10 ...... Mammography Chair ...... 1 A special chair needed for patients who cannot stand to safely have their mammogram performed. 11 ...... Laser Imager Printer ...... 1 Prints high resolution copies of the mammograms to send to surgeons and oncologists, and to use in the OR. 12 ...... Barcode Scanner ...... 1 Allows selection of individual patient file for interpretation. 13 ...... MRS V7 SQL Reporting System ...... 1 MQSA requires that the facility develop and maintain a database that tracks recall rates from screening, true and false positive and true and false negative rates, sensitivity, specificity, and cancer detection rate. A reporting system is required to build the required database and produce the federally required quality audit. Components below needed for the reporting system. The reporting system is currently valued into the existing mammography room. 14 ...... Worksheet Printing Module ...... 1 Database reports are required for federal tracking purposes. This is used to generate reports for MQSA. 15 ...... Site License ...... 1 License for site to use the reporting system. This is a one-time fee. 16 ...... Additional Concurrent User License ..... 3 Licenses for radiologists to use the reporting system. A minimum of three additional licenses is typical. 17 ...... Densitometer ...... 1 Required for MQSA.

We also received specialty society respectively. CPT code 77063 is an add- resource-based PE valuation recommendations for a new Equipment on code to CPT code 77057, the CPT methodology in future rulemaking Item, a physician PACS mammography code for screening mammography. To be would drastically reduce payments. workstation. We note that we discuss consistent with our use of G-codes for Some commenters agreed that CMS does physician PACS workstation in section digital mammography, we did not not have sufficient pricing data to value II.A of this rule. The items that comprise implement two of these three CPT codes digital mammography. One commenter the physician PACS mammography for Medicare purposes. We only adopted stated that the RUC-recommended workstation are listed in Table 19. We CPT code 77063 as an add-on code to direct PE inputs do not need to be re- requested public comment as to the HCPCS code G0202. Instead of adopting considered, as they include pricing data appropriateness of this list and if some stand-alone CPT codes 77061 and provided by the specialty that most items are indirect expenses or belong in 77062, we created a new code, G0279 frequently furnishes the service. other codes. We also invited Diagnostic digital breast tomosynthesis, Response: We will continue to commenters to provide any invoices as an add-on code to the diagnostic carefully consider the potential negative that would help with future pricing of digital mammography HCPCS codes impact that our valuation of these these items. G0204 and G0206 and assigned it values services will have on beneficiary access based on CPT code 77063. Pending as we evaluate all relevant sources of TABLE 19—PHYSICIAN PACS revaluation of the mammography codes data in future rulemaking, including MAMMOGRAPHY WORKSTATION using direct PE inputs, we proposed in data provided by the RUC. CY 2017 to maintain the current coding Comment: A commenter did not PC Tower. structure for digital breast support our intention to seek more Monitors 5 MP (mammo) (x2). tomosynthesis with the technical pricing information in the commercial 3rd & 4th monitor (for speech recognition, change that HCPCS code G0279 be market, stating that commercial payers etc.). reported with CPT codes 77065 or are generally more responsive to market Admin Monitor (the extra working monitor). 77066 as the replacement codes for incentives to reduce rather than increase Keyboard & Mouse. HCPCS codes G0204 and G0206. Powerscribe Microphone. prices. Software—SV APP SYNC 1.3.0. Comment: Many commenters Response: We refer readers to the CY Software—R2 Cenova. expressed support for our decision to 2010 PFS final rule with comment prevent a drastic reduction in payment period (74 FR 61743 through 61748) that We also note that for CY 2015, the for the technical component of these describes CMS’ methodology in CPT Editorial Panel created CPT codes services by maintaining the PE RVUs evaluating practice expense. We would 77061, 77062, and 77063 to describe from CMS’ digital mammography consider a variety of different data unilateral, bilateral, and screening coding. A few commenters expressed sources, pending their availability and digital breast tomosynthesis, concern that shifting to our standard applicability. We believe that having

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more information regarding pricing in prevents a drastic reduction in alternative data sources and we the commercial market may help us to payments. We included potential direct continue to seek information from contextualize recommended pricing, as PE inputs in the text of the CY 2017 interested stakeholders as to the kinds well as potential impact of significant proposed rule to facilitate public of data sources that might be available. changes in payment. comment and information in For CY 2017, we are finalizing the Comment: One commenter expressed anticipation of developing updated PE proposed work RVUs and PE RVUs concern that, despite our maintenance RVUs for these services in future associated with CPT codes 77067, 77066 of PE RVUs and our acceptance of RUC- rulemaking. and 77065 for use with HCPCS codes recommended work RVUs, these Comment: A commenter stated that G0202, G0204, and G0206, respectively. services will still see significant this coding violates statutory (41) Radiation Treatment Devices (CPT payment reductions. requirements set forth by BIPA that Codes 77332, 77333, and 77334) Response: We are accepting the RUC- required the agency to: (1) create recommended work RVUs, which equal separate codes with higher payment We identified CPT codes 77332, the sum of the base code work RVUs for amounts for digital mammography 77333, and 77334 through the high mammography and for CAD. The work compared to film mammography and (2) expenditures by specialty screen. These RVUs for the new mammography coding pay separately when computer-aided services represent an incremental are therefore not changing from their detection (CAD) was used. increase of complexity from the simple current values. Furthermore, as we are Response: The BIPA requirements to the intermediate to the complex in retaining the PE RVUs from the digital specifically refer to screening and design of radiation treatment devices. mammography G-codes in the new diagnostic mammography furnished The RUC recommended no change from coding, the practice expense valuation during the period beginning on April 1, the current work RVUs of 0.54 for CPT is not changing. Therefore, payment 2001, and ending on December 31, 2001. code 77332, 0.84 for CPT code 77333 amounts for mammography services CMS chose to retain the payment rates and 1.24 for CPT code 77334. We will not see significant reductions for for the technical component following believed the recommended work RVUs CY 2017. We expect to revalue these this period. overstate the work involved in services through our standard code Comment: A number of commenters furnishing these services, as they do not valuation process in future rulemaking. volunteered to help CMS in pricing sufficiently reflect the degree to which Comment: One commenter said that direct PE inputs for these services. the RUC concurrently recommended a CMS should accept the RUC- Response: We thank the commenters decrease in intraservice or total time. recommended direct PE inputs. and seek as much information as For CPT code 77332, we believed the Response: As noted earlier, we did possible regarding appropriate RUC recommendation to maintain its not propose the RUC-recommended establishment of direct PE inputs for current value despite a 34 percent inputs for these three codes for several these services. decrease in total time appeared to ignore reasons, including our concerns that Comment: A commenter stated that the change in time. Therefore, we drastic changes in coding and payment the potential reductions to the technical proposed a value for this code based on for these services could be disruptive in component that we are avoiding would a crosswalk from the value from CPT ways that could adversely affect have been based on flawed code 93287 (Peri-procedural device beneficiary access to necessary services, methodology, particularly stating that evaluation (in person) and programming and that unlike almost any other high- the PE per hour values used in PE of device system parameters before or volume PFS service, the RVUs used for ratesetting methodology is inaccurate as after a surgery, procedure, or test with payment for many years have not been it is based on the Physician Practice analysis, review and report by a developed through the generally Expense Information Survey (PPIS) from physician or other qualified health care applicable PFS methodologies. 2007–2008, which the commenter professional; single, dual, or multiple Therefore, instead of proposing to considers to be flawed. The commenter lead implantable defibrillator system), simultaneously adopt the revised CPT also stated that the interest rate applied due to its identical intraservice time, coding and drastic reductions in overall to high cost capital equipment such as similar total time, and similar level of payment rates, we believed it was imaging is inappropriately low, and that intensity. We therefore proposed a work advisable to propose to adopt the new the equipment utilization rate RVU of 0.45 for CPT code 77332. We coding, including the elimination of assumption is inappropriately high. further supported this valuation with separate billing for CAD, for CY 2017 Response: We note that the 90 percent CPT code 97760 (Orthotic(s) without proposing immediate equipment utilization rate only applies management and training (including implementation of the recommended to diagnostic imaging services with assessment and fitting when not resource inputs. equipment priced at $1 million dollars otherwise reported) upper extremity(s), Comment: One commenter requested or more. The most recent recommended lower extremity(s) and/or trunk, each 15 clarification regarding if the PE RVUs inputs for these services do not include minutes), which has similar physician were valued using the RUC- imaging equipment priced at $1 million time and intensity measurements and a recommended direct PE inputs, as these dollars or more, so the 90 percent work RVU of 0.45. As these codes are inputs were posted in Public Use Files equipment utilization would not apply. designed to reflect an incremental (PUFs) for the CY 2017 Proposed Rule. However, we would address any increase in work value from simple, to Response: We thank the commenter application of a different utilization rate intermediate, and complex device for pointing out that direct PE inputs through notice and comment designs, we used an incremental were posted for these codes. These rulemaking when valuing the codes difference methodology to value CPT inputs were inadvertently included in under our standard PE methodology. As codes 77333 and 77334. We proposed a the Public Use Files. We reiterate that always, we welcome information about work RVU of 0.75 for CPT code 77333, we are not implementing PE inputs for the validity of the assumptions we make maintaining its recommended these services, and we are instead in calculation of direct and indirect increment from CPT code 77332. For crosswalking the PE RVUs from the costs in terms of PE. We previously CPT code 77334, we proposed a work digital mammography HCPCS codes noted our interest in improving PE RVU of 1.15, which would maintain its G0202, G0204, and G0206, as doing so calculations through incorporation of increment from CPT code 77332.

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Comment: Several commenters did 93287 to the current physician time of Response: We appreciate the not support CMS’ use of CPT code 77332 or to the survey time on which commenter’s concerns about standard 93287 as a crosswalk code to value CPT the RUC recommendation was based. time packages not being applied to these code 77332, as it is not a radiology One commenter stated that CMS’ codes. We continue to believe, however, service. characterization of the intraservice time that use of the RUC-recommended time Response: We appreciate the of crosswalk CPT code 93287 as to value the work RVU in this case is commenters’ concern about using a non- identical to CPT code 77332 is incorrect; appropriate because we believe that radiology service to assist in our the intraservice time for 77332 is 15 time values are a critical element of valuation of this code family. We note minutes, and the intraservice time of establishing work RVUs. that it is fundamental to the validity of CPT code 93287 is 13.5 minutes. the relative value system that codes Response: We thank the commenter Comment: A few commenters stated furnished by different kinds of for bringing this to our attention; our that CMS’ proposed reduction in the physicians remain valid relative to each previous statement that the intraservice work RVUs for CPT codes 77333 and other. We commonly value codes by use time of CPT code 93287 is identical to 77334 based on an incremental of crosswalks to other codes that are the RUC-recommended intraservice relationship with CPT code 77332 is similar in terms of time and intensity, time is incorrect. The RUC- arbitrary, and that a reduction to the and this may extend across different recommended intraservice time of 15 work RVU for CPT code 77332 does not mixes of specialties furnishing each minutes is similar, but not identical to automatically justify a reduction to the service on the MPFS. the intraservice time of CPT code 93287 other two family codes. Comment: One commenter did not which is 13.5 minutes. We continue to A commenter supported the use of support CMS’ pointing to the RUC’s believe that a work RVU of 0.45 is incremental valuation methodology in recommendation of a reduction of total appropriate because we continue to theory but did not believe it is time without a commensurate reduction believe the overall work for these appropriately applied to these codes, in work RVU, as the current time is a services is approximately the same as because the commenter believes that the CMS/Other source time, which is not 97760. As further support for our valuation of CPT code 77332, upon derived from a survey and was assigned proposed value, we refer to 93016 which the increments are based, is over 20 years ago. (Cardiovascular stress test using incorrect. Response: We utilize a variety of maximal or submaximal treadmill or methodologies and approaches in bicycle exercise, continuous Response: We refer readers to a developing work RVUs, and we believe electrocardiographic monitoring, and/or discussion of the methodology for that the total time value for this service pharmacological stress; supervision establishing work RVUs in section II.L.2 is one of several appropriate criteria that only, without interpretation and report) of this final rule. As outlined there, we can be used to estimate the overall time which has an intraservice time that is frequently use an incremental and intensity. We believe that the identical to the RUC-recommended methodology to identify potential work intraservice and total times listed for intraservice time for 77332, as well as a RVUs for particular codes. We note that this service are valid elements in similar total time. we are maintaining the RUC- allowing us to determine an appropriate Comment: One commenter stated that recommended incremental relationship work RVU. Furthermore, we note that these codes have XXX global periods, between these three codes. This code the current times assigned to this code and therefore, do not have standard pre family is structured to represent simple, have been used to allocate indirect PE or post service packages. These standard intermediate, and complex procedures, to services furnished by the same pre and post services packages did not and we seek to maintain that structure specialties, and use of this value is exist at the time that this service was for this code family. Therefore, we are consistent with code valuation valued, thus the convention of finalizing the work RVUs as proposed. methodology. eliminating pre-service time and We provide the information in Table 20 Comment: One commenter asked for applying minimal post-service time to to illustrate our valuation of CPT code clarification regarding if CMS is services with XXX global periods was 77332 and its value relative to our comparing the total time for CPT code not applied at that time. crosswalk codes:

TABLE 20—VALUATION OF CPT CODE 77332 RELATIVE TO CROSSWALK CODES

HCPCS Description Intra time Total time Work RVU IWPUT

77332—Current ...... Treatment devices, design and construction; simple ...... 28 .54 ...... (simple block, simple bolus). 77332—CMS ...... Treatment devices, design and construction; simple 15 18 .45 0.0126 (simple block, simple bolus). 93287 ...... Peri-procedural device evaluation & programming ...... 13.5 26 .45 0.0126 97760 ...... Orthotic management and training ...... 14 18 .45 0.0257 93016 ...... Cardiovascular stress test ...... 15 19 .45 0.0240

(42) Special Radiation Treatment (CPT and unrelated treatments being addition, we solicited comment to Code 77470) performed by the physician and clinical determine if creating two G-codes, one staff for a typical patient, and this that describes the work portion of this We identified CPT code 77470 presents a disparity between the work service, and one that describes the PE through the high expenditures by RVUs and PE RVUs. We solicited portion, may be a potentially more specialty screen. We proposed the RUC- recommended work RVU of 2.03. comment on information that would accurate method of valuing and paying However, we believe the description of clarify this apparent disparity to help for the service or services described by service and vignette describe different determine appropriate PE inputs. In this code.

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Comment: Some commenters (43) Interstitial Radiation Source Codes Commenters did not agree with our maintained that the clinical labor and (CPT Codes 77778 and 77790) decision not to accept the RUC- physician work component are related In the CY 2016 PFS final rule with recommended work RVU of 8.78 and to and are necessarily reported together. comment period, we established an propose for CY 2017 a work RVU of Commenters did not approve of CMS interim final value for CPT code 77790 8.00, considering the disparity between suggestion of breaking the work and PE without a work RVU, consistent with the survey total time and the RUC- components of this service into two the RUC’s recommendation. We did not recommended total time. According to separate G-codes in future rulemaking, use the RUC-recommended work RVU the RUC, the survey respondents had stating that the CPT descriptor is to establish the interim final values for accurately estimated the work RVU based on magnitude estimation while accurate and represents the typical CPT code 77778. We stated that the overestimating the relatively low patient. Some commenters sought specialty society survey included a intensity pre-service time involved in greater explanation for why CMS work time that was significantly higher performing this service, and this than the RUC-recommended work time believes that the work and PE portions explains the disparity between the without a commensurate change in the of this service are unrelated; survey time and the RUC-recommended work RVU. For CY 2016, we established commenters question if it is because the total time. One commenter noted that the 25th percentile work RVU survey vignettes offered for the work and PE the RUC significantly reduced the pre- result of 8.00 as interim final for CPT describe treatments for two separate time because it did not include work in code 77778 and 0 work RVUs for CPT diagnoses. Commenters also questioned supervising the ordering of the isotope. if CMS is assuming that the ‘‘devices’’ code 77790. Several commenters stated that CMS Comment on the CY 2016 PFS final mentioned in the description of clinical routinely accepts and uses pre-service rule with comment period: Commenters labor activities overlap with Radiation time packages as recommended by the agreed that the preservice survey times Treatment Devices codes which are also RUC. and the RUC-recommended survey being evaluated in this rule. A Response: We continue to question times were inconsistent and explained commenter stated that if CMS is how the same survey respondents that that this inconsistency resulted from the significantly overestimated the total suggesting that there should be multiple RUC’s use of preservice packages in CPT codes for every possible diagnosis time based on the RUC’s analysis could developing recommendations. In nonetheless accurately estimate the for the use of this code, then that addition, commenters stated that suggestion is problematic. overall work. We are also concerned because the work associated with CPT about the specialty society’s perspective Response: According to the code 77790 (including pre-time that the RUC does not consider the work description of work provided for this supervision, handling, and loading of of supervising the ordering of the service, the physician performs radiation seeds into needles) was isotope as part of the service, given the cognitive work such as planning, bundled into CPT code 77778, that the survey respondents clearly considered consideration of test results, and additional work should be reflected in such work to be described by the code. therapeutic treatment contingency the RVU for CPT code 77778. We believe that it is important that a planning that is in addition to what he Commenters encouraged us to accept particular code clearly describes the or she would typically be performing for the RUC-recommended work RVU of work involved in furnishing a service. most radiation treatments. Meanwhile, 8.78 and requested that CPT code 77778 While we appreciate the usefulness of the radiation therapist handles the be referred to the refinement panel. pre-time packages generally, for this Response in the CY 2017 PFS treatment devices, performs tasks such particular code, we believe that in this proposed rule: We did not refer CPT as positioning the patient, and helps case the drastic time difference from the code 77778 to the CY 2016 survey time value to the RUC- facilitate the scan of the patient. We multispecialty refinement panel because believe that this may describe activities recommended time value that the pre- commenters did not provide new time package produces is problematic, that are fundamentally disconnected. To clinical information. We continued to especially since there does not appear to illustrate our concern, we offer the believe that, based on the reduction in be consensus regarding which services example that this is akin to a physician total work time, an RVU of 8.00 are included in the code, or which removing a mole from a patient’s hand accurately reflected the work involved might be perceived to be separately while the clinical staff places a cast on in furnishing CPT code 77778. reportable. the patient’s foot; we see no compelling In the CY 2017 proposed rule, we In general we are concerned with clinical evidence to indicate that the proposed a work RVU of 8.00 for CPT using recommended time values that are two tasks are related. In addition, the code 77778 and 0 work RVUs for CPT disconnected from recommended work disparate diagnoses described by the code 77790. We also sought comment RVUs, including in cases where the vignettes further calls into question the on whether we should use time values recommended work RVU may include degree to which the work and PE based on preservice packages if the elements of work that are not reflected components are interrelated. While we recommended work value was based on in the assumptions in time, as appears agree that there should not separate time values that were significantly to be the case for this code. We reiterate coding for each possible diagnosis for a different than those ultimately that we believe the statute directs us to particular service, in trying to accurately recommended. establish work RVUs that reflect the assess relative value, we believe that the The following is a summary of the relative resource costs in time and work and PE components should be comments we received regarding our intensity, so we believe that there valued under unified assumptions about proposed valuations for CPT codes should be an identifiable relationship 77778 and 77790: the typical service. We are finalizing the between time and work RVUs. Comment: Some commenters stated To align the time and work associated RUC-recommended work RVU and PE that CMS underestimates the additional with this code, we proposed a reduction inputs as proposed; however, we work inherent in furnishing CPT code of the work RVU from 8.78 to 8.00 as we continue to have serious concerns about 77778, considering that it is being proposed. However, upon consideration the validity of this coding. bundled with CPT code 77790. of comments, we were persuaded that

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the RUC-recommended work RVUs for similarities in service, work and on the amount of recycled solvent this service are appropriate, particularly intensity. Based on these concerns, allocated to each specimen, with because the work includes the commenters requested that CPT code solvents allocated to specific specimens supervision, handling, and loading of 78264 be referred to the refinement based on batch size. They indicated that radiation seeds, and it reflects the panel. the related clinical labor tasks are direct bundling with CPT code 77790. Response in the CY 2017 PFS PE as they are also based on the amount While we are not finalizing a change proposed rule: CPT code 78264 was of recycled solvent allocated to each in the time associated with this code referred to the CY 2016 multi-specialty specimen. The time for these tasks since we proposed to use the RUC refinement panel for further review. We varies based on the batch size, which recommended value based on the pre- calculated the refinement panel results varies by procedure. service package, we seek additional as the median of each vote. That result Response in the CY 2017 PFS information regarding the best approach for CPT code 78264 was 0.79 RVUs. proposed rule: We maintained our to valuing work when there is a clear In the CY 2017 proposed rule, we previously stated belief that these are disconnect between assumptions proposed a value of 0.79 for CPT code forms of indirect PE, as they are not regarding time described by a code and 78264. allocated to any individual service. the time recommended by the RUC. We The following is a summary of the Under the established PE methodology, understand that pre-service time comments we received regarding our direct PE inputs are defined as clinical packages can be a helpful tool in proposed valuation of the Colon Transit labor, medical supplies, or medical assigning estimates of time to particular Imaging codes: equipment that are individually codes relative to others on the PFS and Comment: A commenter allocable to a particular patient for a that these times may be significantly recommended that we reexamine the particular service. We continue to different than those derived from survey data associated with these codes to believe that a solvent recycling system results. However, since the RUC has ensure the accuracy of the final values. would be in general use for a lab repeatedly stated that its Response: We thank the commenter practice, and that the associated clinical recommendations reflect the typical for this input. We continue to believe labor tasks for ordering and restocking resources involved in furnishing PFS that the proposed valuation on CPT specimen containers can be more services, we believe it would be code 78264 most accurately describes accurately described as administrative important for us to be able to identify the work, time and intensity associated activities. We proposed to maintain cases where the recommended time with this service; therefore, we are these refinements from the previous values reflect the application of finalizing the work RVU as proposed. rulemaking cycle for CPT codes 88104– particular policies rather than the best (45) Cytopathology Fluids, Washings or 88162. estimate of the actual time involved in Brushings and Cytopathology Smears, Comment on the CY 2016 PFS final furnishing procedures. Screening, and Interpretation (CPT rule with comment period: A commenter indicated that we did not (44) Colon Transit Imaging (78264, Codes 88104, 88106, 88108, 88112, 88160, 88161, and 88162) account for the batch size when 78265, 78266) considering the supply quantities for In establishing CY 2016 interim final In the CY 2016 PFS final rule with CPT codes 88108 and 88112. The values, we accepted the RUC comment period, we made a series of commenter indicated that the practice recommended work RVUs for CPT refinements to the recommended direct expense inputs should be assumed to codes 78265 and 78266. We believed PE inputs for this family of codes. We have a batch size of five for these two that the RUC-recommended RVU of 0.80 removed the equipment time for the codes, and therefore, no edits should be overestimated the work involved in solvent recycling system (EP038) and made. The commenter requested that we furnishing CPT code 78264 and as a the associated clinical labor described restore the quantity of 0.2 for the gloves, result, we established an interim final by the tasks ‘‘Recycle xylene from gowns, and eye shields associated with work RVU of 0.74 based on a crosswalk stainer’’ and ‘‘Order, restock, and these procedures. This did not apply to to CPT code 78226 (hepatobiliary distribute specimen containers and or the other codes on the submitted system imaging, including gallbladder slides with requisition forms’’ due to spreadsheet, which had a batch size of when present), due to similar our belief that these were forms of one. intraservice times and intensities. indirect PE. This refinement applied to Response in the CY 2017 PFS Comment on the CY 2016 PFS final all seven codes in the family. We also proposed rule: We appreciated the rule with comment period: Commenters noticed what appeared to be an error in assistance of the commenter in did not support our interim final work the quantity of non-sterile gloves clarifying the batch size for these RVU for CPT code 78264. Commenters (SB022), impermeable staff gowns procedures. As a result, we proposed to disagreed with our assessment of CPT (SB027), and eye shields (SM016) refine the supply quantity of the non- code 78264 as having a higher work assigned to CPT codes 88108 and 88112. sterile gloves (SB022), impermeable staff RVU and shorter intraservice time The recommended value of these gowns (SB027), and eye shields (SM016) relative to the other codes in the family. supplies was a quantity of 0.2, which back to the RUC-recommended value of One commenter stated that a difference we believed was intended to be a 0.2 for CPT codes 88108 and 88112. of two minutes in intraservice time was quantity of 2. We therefore refined the The following is a summary of the insignificant and should not be used as value of these supplies to 2 for CPT comments we received regarding our a rationale for revaluing. Another codes 88108 and 88112. proposed valuation of the commenter stated that we should have Comment on the CY 2016 PFS final Cytopathology Fluids and maintained the RUC-recommended rule with comment period: Several Cytopathology Smears codes: crosswalk of CPT code 78264 to CPT commenters disagreed with our Comment: A few commenters code 78227 (Hepatobiliary system characterization of the solvent recycling continued to disagree that the proposed imaging, including gallbladder when system and its associated clinical labor refinements to the direct PE inputs were present; with pharmacologic tasks as indirect PE. Commenters stated forms of indirect PE. Commenters stated intervention, including quantitative that the solvent recycling system costs that these tasks are direct expenses, as measurement(s) when performed) due to are direct expenses since they are based they are variable based on the volume

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of these services, with the clinical labor 2016 PFS final rule with comment cytometry on a per patient case basis, as and equipment time directly attributable period. The full family of codes was these two procedures are always to the quantity of specimens typically reviewed again at the January 2016 RUC performed together and it is difficult to provided from a typical laboratory. meeting, and new recommendations determine the clinical labor, supplies, Commenters also stated that these were submitted to CMS as part of the CY and equipment used in the typical case activities were not captured in the 2017 PFS rulemaking cycle. under the current coding structure. We questions asked on the indirect practice We proposed the RUC-recommended solicited comments regarding the public expense cost survey. work RVU of 0.74 for CPT code 88187, interest in consolidating these two Response: We continue to believe that and the RUC-recommended work RVU procedures into a single code used to these are administrative tasks that are of 1.70 for CPT code 88189. For CPT describe the technical component of more accurately classified as forms of code 88188, we proposed a work RVU flow cytometry. indirect PE because they are not of 1.20 instead of the RUC- Absent such a change in coding, we allocable to an individual service. recommended work RVU of 1.40. We proposed to refine the clinical labor Whether these tasks are variable based arrived at this value by noticing that time for ‘‘Instrument start-up, quality on the volume of the services is there were no comparable codes with no control functions, calibration, unrelated to this classification. For global period in the RUC database with centrifugation, maintaining specimen example, some services may require intraservice time and total time of 30 tracking, logs and labeling’’ from 15 additional time for administrative staff minutes that had a work RVU higher minutes to 13 minutes for CPT code to record electronic health records or than 1.20. The RUC-recommended work 88184. We maintained that 13 minutes restock inventory than other services, RVU of 1.40 would go beyond the for this activity, which is the current but in all cases these are defined as current maximum value and establish a time value, would be typical for the indirect PE under the established new high, which is not consistent with procedure, as CPT code 88182 also uses methodology, as they are administrative our estimation of the overall intensity of 13 minutes for the identical clinical tasks that are not allocated to any this service relative to the others. As a labor task. We also proposed to refine individual service. We disagree that the result, we believe it is more accurate to the L054A clinical labor for ‘‘Load validity of the practice expense data crosswalk CPT code 88188 to the work specimen into flow cytometer, run rests on whether or not particular value of the code with the current specimen, monitor data acquisition, and questions were asked on the survey. We highest value, which is CPT code 88120 data modeling, and unload flow note that we understand medical (Cytopathology, in situ hybridization cytometer’’ from 10 minutes to 7 practice and technology often change (for example, FISH), urinary tract minutes using the same rationale, a over time and the PE survey data is used specimen with morphometric analysis, comparison to CPT code 88182. to capture the relative difference in 3–5 molecular probes) at a work RVU of We proposed to maintain the clinical practice expenses incurred by various 1.20. We believe that CPT code 88120 is labor for ‘‘Print out histograms, specialties as opposed to representing a crosswalk comparable code since it assemble materials with paperwork to summation of all individual items that shares the identical intraservice time pathologists Review histograms and incur an expense. Therefore, we do not and total time of 30 minutes with CPT gating with pathologist’’ for CPT code believe that inclusion or exclusion of code 88188. 88184 at 2 minutes, as opposed to the particular items means that the We also noted that the survey RUC-recommended 5 minutes. A underlying data are invalid for purposes increment between CPT codes 88187 clinical labor time of 2 minutes is of measuring relativity. and 88188 at the RUC-recommended standard for this activity; we disagree Comment: A commenter agreed with 25th percentile was 0.40 (between work with the RUC rationale that reviewing the changes to the RUC-recommended RVUs of 1.00 and 1.40), and this histograms and gating with the supply quantity of 0.2 for the non-sterile increment of 0.40 when added to CPT pathologist in this procedure is not gloves (SB022), impermeable staff code 88187’s work RVU of 0.74 would similar to other codes. We also note that gowns (SB027), and eye shields (SM016) arrive at a value of 1.14. In addition, the the review of histograms with a in CPT codes 88108 and 88112. total time for CPT code 88188 decreases pathologist is not even described by Response: We appreciate the support from 43 minutes to 30 minutes, which CPT code 88184, which again refers to from the commenter. is a ratio of 0.70, and when this time the technical component of flow After consideration of comments, we ratio is multiplied by CPT code 88188’s cytometry, not the professional are finalizing the proposed direct PE previous work value of 1.69, the result component. We also proposed to refine inputs for CPT codes 88104, 88106, would be a new work RVU of 1.18. With the L033A clinical labor time for ‘‘Clean 88108, 88112, 88160, 88161, and 88162. this information in mind, we proposed room/equipment following procedure’’ a work RVU of 1.20 for CPT code 88188 from 2 minutes to 1 minute for CPT (46) Flow Cytometry Interpretation (CPT as a result of a direct crosswalk to CPT code 88184. We have established 1 Codes 88184, 88185, 88187, 88188, and code 88120. minute in previous rulemaking (80 FR 88189) For CPT codes 88184 and 88185, 70902) as the standard time for this The Flow Cytometry Interpretation which describe the technical component clinical labor activity in the laboratory family of codes is split into a pair of of flow cytometry, we proposed to use setting. codes used to describe the technical the RUC-recommended inputs with a We proposed to maintain our removal component of flow cytometry (CPT series of refinements. However, we of the clinical labor time for ‘‘Enter data codes 88184 and 88185) that do not believe that the coding for these two into laboratory information system, have a work component, and a trio of procedures may inhibit accurate multiparameter analyses and field data codes (CPT codes 88187, 88188, and valuation. CPT code 88184 describes the entry, complete quality assurance 88189) that do not have direct practice first marker for flow cytometry, while documentation’’ for both CPT code expense inputs, as they are professional CPT code 88185 is an add-on code that 88182 and CPT code 88184. As we component only services. CPT codes describes each additional marker. We stated in the CY 2016 PFS final rule 88184 and 88185 were reviewed by the believe that it may be more accurate to with comment period (80 FR 70979), we RUC in April 2014, and their CMS have a single CPT code that describes have not recognized the laboratory refined values were included in the CY the technical component of flow information system as an equipment

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item that can be allocated to an with comment period (80 FR 70979), we which would collapse the codes into a individual service. We continue to proposed to assign equipment time for series of case rate codes that reflect the believe that this is a form of indirect PE, the dye sublimation printer to match the procedures: screening, classification, and therefore, we do not recognize the clinical labor time for ‘‘Print out and monitoring. There was support from laboratory information system as a histograms, assemble materials with one additional commenter for a three direct PE input, and we do not consider paperwork to pathologists.’’ We do not code proposal designed to track this this task as typically performed by believe that it would be typical for the workflow. clinical labor on a per-service basis. printer to be in use longer than it takes Response: We appreciate the detailed We proposed to maintain the quantity to accomplish this clinical labor task. responses from the commenters about of the ‘‘lysing reagent’’ supply (SL089) The following is a summary of the the proper coding structure used to at 2 ml for CPT code 88185, as opposed comments we received regarding our describe the technical component of to the RUC-recommended quantity of 3 proposed valuation of the Flow flow cytometry. We do not intend to ml. In our discussions with pathology Cytometry Interpretation codes. Due to finalize any recommendations regarding specialists who perform flow cytometry, the large number of comments we the coding structure at this time, but we we were informed that the use of 50–55 received for this code family, we will will consider this information for future ml of the lysing reagent would be first summarize the comments related to proposals regarding these services. typical for an entire patient case. The the coding structure of CPT codes 88184 Comment: Many commenters made RUC recommendation similarly and 88185, followed by the comments general comments about decreases to suggested a quantity of 46 ml or 48 ml related to specific work RVUs, and the proposed rates for either the per patient case. We were also told that finally the comments related to the professional or the technical component the most typical number of markers direct PE inputs. of the flow cytometry codes. used for flow cytometry is 24, consisting Comment: Many commenters Commenters stated that there was no of 1 service of CPT code 88184 and 23 disagreed with the potential concept of justification for the reduction in services of CPT code 88185. An consolidating CPT codes 88184 and payment rates, and that the decreases investigation of our claims data 88185 into a single code used to would hamper laboratories’ ability to confirmed this information, indicating describe the technical component of offer the flow cytometry services. One that 24 markers is the most frequent per flow cytometry. Commenters stated that commenter stated that the payment cuts patient case for flow cytometry, and the the resources required for the first were not realistic and would result in use of more than 20 markers is typical. marker and for each subsequent marker flow cytometry not being financially We believe that this data supports our differ, and with flow cytometry, there is feasible in the less expensive physician- refinement of the lysing reagent from a no ‘‘typical case.’’ Because the number office setting. Another commenter quantity of 3 ml to a quantity of 2 ml of markers differ for different disease indicated that further reductions to for CPT code 88185, which is also the states, such as HIV, Lyme disease, and these codes would result in an inability current value for the procedure and the acute leukemias, the current coding to maintain the level of professional RUC-recommended value from the structure is designed to reflect different services required to reduce medical previous set of recommendations. For valuations of the professional errors. the typical case of 24 markers, our value component codes, based on the number Response: We share the concern of the would produce a total lysing reagent of markers that must be interpreted. commenters in ensuring that payment quantity of 51 ml (5 ml from the single Many commenters stressed that this for Medicare services is based on an service of CPT code 88184 and 46 ml makes one code for the technical accurate assessment of the relative from the 23 services of CPT code component of flow cytometry infeasible, resource costs involved in furnishing 88185), which matches with the amount and strongly advised against it. One the service. With regards to the required for a total per patient case. If commenter was also concerned that a technical component of flow cytometry, we were to adopt the RUC coding structure change may exacerbate most of the decrease in code valuation recommendation, the total lysing the undervaluation of these services, is taking place due to a decrease in the reagent quantity would be 74 ml, which which have been recently reviewed quantity of the lysing reagent supply is well in excess of what we believe to twice by the RUC and resulted in (SL089). The RUC has agreed that there be typical for these procedures. substantial decreases in the practice was previously an excess of this supply We also proposed to refine the expense relative values. in CPT codes 88184–88185, and has quantity of the ‘‘antibody, flow A few commenters supported the recommended a decrease of cytometry’’ supply (SL186) from possibility of combining CPT codes approximately 78 percent in this supply quantity 1.6 to quantity 1, which is also 88184 and 88185 into a single code. One quantity, from 336 ml to 74 ml, in the the current value for the supply and the commenter stated that the current typical case of 24 markers. Due to the RUC-recommended value from the coding structure does not incentivize resource-based nature of the RVU previous set of recommendations. We the use of less reagents, and actually system, this substantial reduction in do not agree that more than one penalizes labs that appropriately test supply costs will be reflected in the antibody would be typically used for fewer markers. According to this RVUs for these procedures. We note that each marker. We are reaffirming the commenter, moving to a single code since CY 2016 the phase-in of previous RUC recommendation, and structure would be consistent with the significant reductions in RVUs has been maintaining the current quantity of 1 vast majority of lab tests, would in effect; if the total RVUs for a service antibody for each marker. simplify billing processes, and may for a year would otherwise be decreased We did not agree with the make development of more cost- by an estimated 20 percent or more as recommended additional time for the effective panels financially desirable. compared to the total RVUs for the ‘‘printer, dye sublimation (photo, The commenter supported further previous year, those decreases are color)’’ equipment (ED031). We examination of a single CPT code and limited to a 19 percent reduction in total proposed to maintain the equipment urged that current payment rates should RVUs. We note that the phase-in time at 2 minutes for CPT code 88184, be frozen while such examination mechanism allows reductions to be and at 1 minute for CPT code 88185. As occurs. Another commenter suggested a transitioned in over time rather than we stated in the CY 2016 PFS final rule slightly different coding structure, one instituting large decreases in a single

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rule cycle. Please see section II.H for TABLE 21: WORK RVU OF CODES RUC-recommended work RVU of 1.40 more information regarding the phase-in WITH COMPARABLE TIME VALUES TO for CPT code 88188. of significant RVU reductions. CPT CODE 88188—Continued Response: We disagree that the survey Comment: Many commenters data justifies a smaller increment disagreed with the proposed work RVU between the final two codes. While this HCPCS Descriptor Work of 1.20 for CPT code 88188. Several RVU is true for the 25th percentile survey commenters took issue with the CMS results, the exact opposite is true for the statement that there were no comparable 88374 ...... M/phmtrc alys 0.93 survey median results, in which the codes with no global period in the RUC ishquant/semiq. increment between CPT codes 88187 93750 ...... Interrogation vad in 0.92 and 88188 is 0.35 and the increment database with intra-service time and person. total time of 30 minutes that had a work 95251 ...... Gluc monitor cont 0.85 between CPT codes 88188 and 88189 is RVU higher than 1.20. These phys i&r. 0.70. In addition, in the current pre- commenters indicated that there were at 97004 ...... Ot re-evaluation ...... 0.60 reviewed version of these codes, the least 10 such codes valued over 1.20 97606 ...... Neg press wound tx 0.60 increment between CPT codes 88187 RVUs in the 2016 RUC database (1 XXX >50 cm. and 88188 is 0.33, while the increment and 9 ZZZ add-on global codes), ranging between CPT codes 88188 and 88189 is in work value from 1.38 to 2.40 RVUs, As we stated previously, there are no 0.54. We believe that this suggests the with a median of 1.67. The commenters codes with a work RVU higher than survey data on the work increments is suggested that these codes supported 1.20, which is where we proposed to conflicting, not conclusive, and that the the higher RUC-recommended work value CPT code 88188. We acknowledge RUC-recommended increments are a RVU of 1.40 for CPT code 88188. that there are global XXX codes with 30 departure from the previous incremental Response: We continue to believe that minutes of intraservice time that have a structure of this code family, in which there are no comparable codes with the work RVU greater than 1.20. However, the second two codes had a larger same global period with intraservice all of these codes have at least 40 increment than the first two codes. We time and total time of 30 minutes that minutes of total time, which is 33 do not agree that the work increments have a work RVU higher than 30 percent higher at a minimum than the at the survey 25th percentile are a minutes. When we used the phrase ‘‘no total time for CPT code 88188. We sufficient justification for adopting the global period’’ to refer to CPT code believe that a crosswalk to CPT code recommended work RVU for CPT code 88188, we were not referring to add-on 88120, which shares the identical time 88188 due to the additional data values as CPT 88188, is a more codes with a global period of ZZZ. We regarding work increments between appropriate choice than codes that have have stated on numerous occasions that these codes detailed above. substantially higher total time. In the Comment: Several commenters stated we believe the resources required to particular case of CPT code 88188, we that over the last decade, flow furnish add-on codes constitute a continue to believe that establishing a cytometric analyses have changed separate category, and we typically only new maximum work value above 1.20 through new technological advances compare add-on codes to other add-on would not be consistent with our that have led to an increased codes. We do not believe that it is estimation of the overall intensity of this interpretative sophistication. It is now appropriate to compare the work RVU of service relative to the others on the PFS. typical for the physician to analyze add-on codes with 30 minutes of Comment: Some commenters substantially more data than in the past. intraservice time to the work RVU of disagreed with the proposed work RVU According to commenters, with the CPT code 88188, which is not an add- of CPT code 88188 based on the work advent of 5, 6, 8, and 10 color flow on code. increments between the codes in the cytometry the intensity and complexity With regards to non-add on codes, family. These commenters stated that of these services has significantly Table 21 lists all 13 codes in the RUC the original recommended work values increased. Commenters stated that this database with 30 minutes of intraservice had almost identical increments increased intensity and complexity is time, fewer than 40 minutes of total between the three services (0.60 reflected in the RUC recommendation time, and a global period of XXX: between CPT codes 88187 and 88188, for this service, based on new physician and 0.63 between CPT codes 88188 and work associated with technological TABLE 21: WORK RVU OF CODES 88189); however the median survey changes, time, and intensity. WITH COMPARABLE TIME VALUES TO results indicated a much greater Response: We appreciate this CPT CODE 88188 physician work increment between CPT additional information about the codes 88188 and 88189. According to professional interpretation of flow HCPCS Descriptor Work commenters, the final RUC cytometry from the commenters. RVU recommendations were based on the However, we note that the RUC- 77331 ...... Special radiation do- 0.87 expertise of the RUC to establish the recommended intensity of CPT codes simetry. work increment between CPT codes 88187 and 88189 has actually decreased 78195 ...... Lymph system imag- 1.20 88187 and 88188 (0.74) higher than the compared to the current pre-reviewed ing. increment between CPT codes 88188 version of these codes. We believe that 78456 ...... Acute venous throm- 1.00 and 88189 (0.30). In other words, the this indicates that the same new bus image. recommended work increment between technological advances also allow 86079 ...... Phys blood bank serv 0.94 CPT code 88187 (work RVU = 0.74) and practitioners to analyze data faster and authrj. CPT code 88188 (work RVU = 1.40) was with fewer errors, which is reflected in 88120 ...... Cytp urne 3–5 probes 1.20 significantly larger than the work the decreased work RVUs and time ea spec. increment between CPT code 88188 values in the RUC recommendations. 88187 ...... Flowcytometry/read 0.74 2–8. (work RVU = 1.40) and CPT code 88189 The only one of the three codes with a 88365 ...... Insitu hybridization 0.88 (work RVU = 1.70). The commenters RUC-recommended increase in intensity (fish). stated that the survey results and expert is CPT code 88188. This increased 88368 ...... Insitu hybridization 0.88 opinion justified this smaller increment intensity in the second code creates an manual. between the final two codes, and the anomalous relationship within the

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family, as the RUC-recommended that many of the activities listed by the CPT code 88182 was not appropriate as intensity for CPT code 88188 is equal to commenter are not detailed in the CPT code 88184 uses 4–6 color channel the intensity for CPT code 88189, in intraservice work description for CPT instruments and up, while 88182 uses contrast to the current pre-reviewed code 88188, and may not be needed in only 1–2 channels. According to the version of these codes where the three the typical case. commenters, the time it takes for data codes have a linear increase in intensity The following comments address the capture, data modeling, data (IWPUT = 0.39, 0.43, 0.50). We do not proposed direct PE inputs for the Flow acquisition, and computational analysis understand why the professional Cytometry family of codes. is exponentially longer for CPT code interpretation of 9 to 15 markers would Comment: Many commenters 88184 than for CPT code 88182, since have an equal intensity to interpreting disagreed with the proposed time of 13 additional colors result in more 16 or more markers. Logic would minutes for the clinical labor activity complicated profiles which are more suggest that CPT code 88188 should ‘‘Instrument start-up, quality control difficult and time consuming to have a lower intensity than CPT code functions, calibration, centrifugation, evaluate. Another commenter stated that 88189, which is indeed the case at our maintaining specimen tracking, logs and 7 minutes was wholly inadequate to proposed work RVU of 1.20. The labeling.’’ Commenters stated that the perform all of these tasks, and that proposed value also re-establishes a CMS comparison to CPT code 88182 analysis of a specimen can take 12 to 15 linear increase in intensity between the was not appropriate, as that code uses minutes, depending on the complexity three codes as additional markers are older/simpler technology, with CPT of the case. interpreted (IWPUT = 0.37, 0.40, 0.47). code 88184 using 4–6 or more color Response: We continue to disagree We believe that this intensity data offers channels while CPT code 88182 uses with the commenters that the identical additional support for our proposed 1–2 channels. Commenters stressed that clinical labor activity would take longer work RVU. these clinical labor tasks are unique to to perform for CPT code 88184 than it Comment: One commenter disagreed this flow cytometry service, and they would for CPT code 88182. As we stated with the CMS crosswalk to the work should not be assumed to take the in response to the previous comment, RVU of CPT code 88120, which the identical time as other services. Other we do not agree that there is additional commenter suggested was completely commenters stated that three clinical labor time required for using different in step by step work effort, instruments must be run consecutively, additional color channels in CPT code intensity, and complexity. The and the task includes quality control 88184, as the same equipment is being commenter stated that CPT code 88120 calibration, taking a minimum of 13 to used to perform the same clinical labor typically only involves identifying and 16 minutes in dedicated technical staff task as in CPT code 88182. For the same quantifying a limited subset molecular time. Another commenter indicated that reason, we do not agree that this clinical probes (for example, FISH probes for the time required to complete these labor activity takes 12 to 15 minutes to chromosomes 3, 7, 17 and 9p21 loss), activities is continually increasing as perform, since the identical task only using two to four color signal more regulatory requirements are added, requires 7 minutes for CPT code 88182. enumeration to detect aneuploidy and that the recently added flow Comment: Many commenters opposed staining of nuclei on slides from cytometry requirement for individual the proposed value of 2 minutes for the isolated cell preparations, usually from antibody lot/shipment testing increased clinical labor activity ‘‘Print out morphologically well-characterized this time exponentially. histograms, assemble materials with specimens. In contrast, the commenter Response: We disagree with the paperwork to pathologists Review stated that for CPT code 88188 the commenters that the identical clinical histograms and gating with pathologist’’ pathologist is required to integrate labor activity would take longer to for CPT code 88184. Commenters stated multi-parameter diagnostic information perform for CPT code 88184 than it that it was not reasonable to expect that on different cell populations (both would for CPT code 88182. Both of a flow cytometry technologist could abnormal and normal), by assessing cell these procedures use the same print out histograms, assemble the scatter (size and shape) along with equipment to perform this task, a flow documents and deliver them to a signal intensity and pattern of staining cytometer (EP014) and a centrifuge pathologist, and review the histograms of cell surface markers with antibody (EP007). We do not agree that there is with a pathologist, all in the span of a reagents using four to six (or more) color additional clinical labor time required mere 120 seconds. Commenters were fluorescent antibody probes. The for using additional color channels in concerned that flow cytometry pathologist must perform successive, CPT code 88184, as the same equipment technologists cannot produce a high- iterative analyses of 2- and 3- is being used to perform the same quality product and ensure its accuracy dimensional plots and histograms and clinical labor task as in CPT code 88182. and completeness for presentation to a re-gating of identified cell populations We did not receive data from the pathologist in the proposed time. One (based on size, shape, relative staining commenters suggesting that regulatory commenter noted that although their patterns, signal intensity, etc.) to requirements are increasing the time specific procedure for these steps was characterize cell lineage and render a required to perform this clinical labor largely electronic, their workflow final diagnosis and interpretation. Due task, nor was this reflected in the RUC analysis corroborated the RUC’s to this clinical rationale, the commenter recommendations, which continued to conclusion because it showed that it indicated that the work and complexity recommend the same unchanged time took 5 minutes for staff to complete the of CPT code 88188 was substantially for this task. equivalent activities. Several other greater than CPT code 88120. Comment: Many commenters objected commenters stated that if the time the Response: We disagree with the to the proposed clinical labor time of 7 cyotechnologist takes to determine commenter that CPT code 88120 is an minutes for the ‘‘Load specimen into exactly which histograms to print is inappropriate crosswalk code for CPT flow cytometer, run specimen, monitor subtracted, then they could agree with code 88188. These codes are both data acquisition, and data modeling, the proposed 2 minutes. Commenters recently-reviewed pathology codes with and unload flow cytometer’’ activity for also stated that printing is not identical intraservice time and total CPT code 88184. Commenters stated performed all at one time, with 25–30 time values within the Cytopathology that the CMS comparison to the clinical pages of information and data printed listing of the CPT manual. We also note labor time used for this same activity in over a 5 minute time span, and one

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commenter indicated that the process information takes additional time that other relevant pieces of information. was ‘‘largely electronic’’ with clinical cannot be short-changed. Commenters The commenters indicated that an staff not using the equipment for the full emphasized that these are extremely analysis of the 2014 Medicare 5% duration that it is in use. important tasks that require technical Sample Carrier Database showed that Response: We appreciate the support skills, and assigning zero minutes to this over 50 percent of individual providers from several of the commenters. In critical task was illogical for a service typically bill fewer than 20 markers per responding to the comments for this like flow cytometry. One commenter patient case, and that since these clinical labor activity and the stated that the current RUC- providers are generally smaller and see equipment time for the dye sublimation recommended value of four minutes fewer annual cases, the proposed supply printer (ED031), it became clear that the was already a gross underestimation of quantity of 2 would potentially drive clinical labor time for printing was not the time required to complete these these providers to consider ceasing their the same as the equipment time that the activities for the majority of testing, and flow cytometry services. The commenter printer was in use. Based on the suggested that these activities also stated that these codes are often information from the commenters that commonly take more than ten minutes billed as part of either the Hospital IPPS printing is not performed all at one to perform. or OPPS, which should be factored into time, we are assigning the full 5 minutes Response: We agree with the the typical number of markers billed per of equipment time for the dye commenters that entering patient data case. The commenter also stated that the sublimation printer; however, we are into information systems is an most common professional component maintaining our proposed 2 minutes of important task, and we agree that it of flow cytometry, CPT code 88189, clinical labor time for ‘‘Print out would take more than zero minutes to would be associated with patient cases histograms, assemble materials with perform. However, the commenters did that bill for fewer than 24 markers, from paperwork to pathologists Review not address our rationale for removing 16 to 24. histograms and gating with pathologist’’, this clinical labor time from CPT codes Response: We reiterate that we as commenters have informed us that 88184 and 88185, which is that this task establish payment rates based on the the clinical staff do not use the is indirect PE. As we stated in the CY typical case, which the commenters equipment for the full duration that it is 2016 final rule with comment period (80 agreed was 24 total markers. We have in use. FR 70979), we have not recognized the historically established payment rates Comment: Several commenters laboratory information system as an based on the typical service and do not disagreed with the proposed clinical equipment item that can be allocated to believe that it would be appropriate or labor time of 1 minute for ‘‘Clean room/ an individual service. We continue to serve the purpose of relativity to deviate equipment following procedure’’ for believe that this is indirect PE, and from that practice in this case. We also CPT code 88184. The commenters stated therefore, we do not recognize the do not believe that the payment for that this time is allocated over entire laboratory information system as a these codes under the IPPS or OPPS is patient case, and that it is typical and direct PE input, and we do not consider a directly relevant factor in defining the critical to clean the equipment between this task as typically performed by typical case under the Physician Fee patient cases. The commenters also clinical labor on a per-service basis. Schedule. We believe that the patient supplied details about the cleaning Comment: One commenter requested population and typical case under the process, regarding how the laboratory the inclusion of additional IPPS would not necessarily be the same technician cleans the equipment and cytotechnologist time of 10 minutes for as the typical case under the PFS. workspace by decontaminating the CPT code 88184 and 2 minutes for CPT Finally, we agree that CPT code 88189 equipment and work bench surfaces, as code 88185, as well as an additional would be associated with patient cases well as carrying out waste management desktop computer with monitor (ED021) that bill for fewer than 24 markers, as after the procedure. equipment times of 10 minutes for the code descriptor states that it refers Response: We appreciate the 88184 and 2 minutes for 88185. This to the performance of 16 or more additional information from the additional time was intended to reflect markers. However, we do not believe commenters regarding the cleaning of the time spent using the flow cytometry that this affects the number of markers the room. However, the commenters did analytics software (EQ380). in the typical case, which the not provide a rationale as to why CPT Response: We agree with the RUC commenters agreed was 24 for the code 88184 requires additional clinical recommendations that the clinical labor typical patient. labor above the standard value of 1 and equipment time associated with the Comment: A commenter stated that minute for room cleaning in lab flow cytometry analytics software is that it opposed putting a number or cap procedures. We continue to believe that already accounted for in the on markers because there is a wide the standard clinical labor time is the recommended clinical labor inputs. As range of possible markers required to most accurate valuation for this clinical the recommendations indicate, this time achieve patient diagnosis. labor task. is included as part of the clinical labor Response: We agree with the Comment: Many commenters activities ‘‘Accession specimen’’, commenter, and we are not establishing requested that CMS restore the clinical ‘‘Instrument start-up, quality control a cap or determining a fixed number of labor time for the ‘‘Enter data into functions’’, ‘‘Load specimen into flow markers to use for these procedures. As laboratory information system, cytometer, run specimen’’ and ‘‘Print stated previously, however, we are multiparameter analyses and field data out histograms, assemble materials with required to establish payment rates entry, complete quality assurance paperwork to pathologists.’’ based on the typical case, which our documentation’’ activity. Commenters Comment: Many commenters internal data and commenter feedback stated that this data entry is manually disagreed with the proposed supply has agreed is 24 markers. entered and must be performed for each quantity of 2 for the lysing reagent Comment: Other commenters individual patient case. Several (SL089) in CPT code 88185. disagreed with the CMS proposal for the commenters indicated that entering test- Commenters stated that although they lysing reagent based on the supply specific data takes between five and ten acknowledged that the current Medicare quantity needed to perform the minutes, and entry of client information data showed that a patient case of 24 procedure. A commenter stated that the and demographics and specimen markers is typical, this result ignored 46–48 mL quantity detailed by CMS in

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the proposed rule was based on a RUC greater than 1 antibody per marker refinement to the dye sublimation recommendation; however, the RUC’s reported. printer detailed above. amount was based on an average of 16 Response: We appreciate the (47) Microslide Consultation (CPT markers, not 24 markers. Although the additional data presented regarding the Codes 88321, 88323, and 88325) commenter agreed that 24 markers clinical use of the flow cytometry reflected a common case, the antibody supply. However, we continue CPT codes 88321, 88323, and 88325 commenter stated that it was necessary to have reservations regarding the were reviewed by the RUC in April 2014 to consider the amount of lysing agent information that we have received for their direct PE inputs only, and the for a 24 marker case, not to assume that regarding the 1.6 quantity for this CMS refined values were included in the 46–48 mL amount based upon 16 supply. Different commenters the CY 2016 PFS final rule with markers also applies to 24 markers. recommended different quantities of comment period. The family of codes Another commenter stated that a this supply required to furnish the was reviewed again at the January 2016 laboratory using ammonia chloride procedure, ranging from 1 to 1.36 to RUC meeting for both work values and needs at least 2.5 ml of lysing reagent 1.52 to 1.6 to 1.87. We are hesitant to direct PE inputs, and new for each time that CPT code 88185 is increase the quantity of this supply recommendations were submitted to performed. given the wide-ranging information that CMS as part of the CY 2017 PFS Response: We did not base our we received from commenters. We are rulemaking cycle. In the CY 2016 PFS final rule with proposal for this supply quantity upon also concerned that although comment period, we finalized our the RUC recommendation. As we stated commenters referenced studies that proposal to remove many of the inputs in the proposed rule, we were informed found different supply quantities for for clinical labor, supplies, and that the use of 50–55 ml of the lysing SL186, commenters did not submit the equipment for CPT code 88325. The reagent would be typical for an entire data associated with these studies for descriptor for this code did not state patient case based on our discussions our review. We would be more open to that slide preparation was taking place, with pathology specialists who perform the idea of increasing the supply and therefore, we refined the labor, flow cytometry. For the typical case of quantity to 1.6 if this data were supplies, and equipment inputs to align 24 markers, our value would produce a supported by clinical data or study. We total lysing reagent quantity of 51 ml (5 with the inputs recommended for CPT also note that one commenter stated that code 88321, which also does not ml from the single service of CPT code one antibody is ‘‘generally used’’ per 88184 and 46 ml from the 23 services include the preparation of slides. After marker, which supports our contention further discussion with pathologists and of CPT code 88185), which matches that the proposed value of 1 antibody with the amount required for a total per consideration of comments received, we for CPT codes 88184 and 88185 would have been persuaded that slide patient case. Since commenters agreed be typical. As a result, we are that 24 markers was the typical patient preparation does take place in maintaining a supply quantity of 1 for conjunction with the service described case, we continue to believe that our the flow cytometry antibody supply, proposed quantity of 2 ml is the most by CPT code 88325. In the RUC- which is also the current value for the accurate value for CPT code 88185. recommended direct PE inputs from the supply and the RUC-recommended Comment: Many commenters objected January 2016 meeting, the labor, to the proposed supply quantity of 1 for value from the previous set of supplies, and equipment inputs related the flow cytometry antibody (SL186) in recommendations. to slide preparation were added once CPT codes 88184 and 88185. Comment: Several commenters again to CPT code 88325. We proposed Commenters stated that although it is disagreed with the proposed equipment to accept these restorations related to standard practice to use a single time for the dye sublimation printer slide preparation without refinement. antibody multiple times during the (ED031). Commenters stated that Regarding the clinical labor direct PE analysis, each antibody or marker can printing is not performed all at one inputs, we proposed to assign 1 minute only be billed once per analysis. time, with 25–30 pages of information of L037B clinical labor for ‘‘Complete According to commenters, multiple use and data printed over a 5 minute time workload recording logs. Collate slides of such antibodies are not reportable or span. Commenters indicated that this and paperwork. Deliver to pathologist’’ billable, but are critical to the overall time cannot be linked directly to one for CPT codes 88323 and 88325. We are analysis and interpretation of results particular clinical labor task line, and maintaining this at the current value for and are part of the total cost for each the printer cannot be used for any other CPT code 88323, and adding this 1 procedure performed. Some task during these 5 minutes even while minute to CPT code 88325 based on our commenters explained that the it is not actively printing. new understanding that slide recommended quantity of 1.6 antibodies Response: We appreciated the preparation is undertaken as part of the per billed marker was based on additional information from the service described by this code. We averaging together two separate commenters regarding the use of the dye proposed to remove the clinical labor analyses: a survey of 59 professionals sublimation printer. Due to the for ‘‘Assemble and deliver slides with performing flow cytometry that found presentation of this new information paperwork to pathologists’’ from all 1.52 antibodies required per marker, detailing how the equipment time for three codes, as we believe this clinical and a customer survey that found 1.87 the printer is disassociated from any labor is redundant with the labor antibodies per marker. A different clinical labor tasks, we will increase the assigned for ‘‘Complete workload commenter stated that its member equipment time to the RUC- recording logs.’’ We similarly proposed laboratories found that under the recommended 5 minutes for CPT code to remove the clinical labor for ‘‘Clean current four-color process, 1.36 88184 and 2 minutes for CPT code equipment while performing service’’ antibodies per marker is necessary. 88185. from CPT codes 88323 and 88325, as we Another commenter stated that while After consideration of comments believe it to be redundant with the one antibody is generally used per received, we are finalizing the proposed clinical labor assigned for ‘‘Clean room/ marker, the required use of controls for work RVUs for CPT code 88187, 88188, equipment following procedure.’’ many of these markers for analysis or and 88189. We are also finalizing the We proposed to maintain the quantity quality control means that this value is proposed direct PE inputs, with the of the ‘‘stain, hematoxylin’’ supply

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(SL135) at 16 ml for CPT codes 88323 microscopic examination), 88309 (Level necessary task that was not redundant and 88325, as opposed to the RUC- VI—Surgical pathology, gross and with other clinical labor activities. recommended quantity of 32 ml. The microscopic examination), 88364 (In Response: We agree with the RUC recommendation stated that the situ hybridization (e.g., FISH), per commenters that 1 minute of clinical hematoxylin supply does not include specimen; each additional single probe labor time for this task is an appropriate eosin and should not be redundant; the stain procedure), 88365 (In situ addition for CPT 88321 to be consistent stains are not mixed together, but are hybridization (e.g., FISH), per specimen; with the identical clinical labor task instead sequential. The initial single probe stain procedure), taking place in other codes in the recommendation also made a 88366 (In situ hybridization (e.g., FISH), family. comparison to the use of the per specimen; each multiplex probe After consideration of comments hematoxylin supply quantity in CPT stain procedure), 88367 (Morphometric received, we are finalizing our proposed code 88305. However, we note that CPT analysis, in situ hybridization work RVUs for CPT code 88321, 88323, code 88305 does not include 8 ml of (quantitative or semi-quantitative), and 88325. We are also finalizing the eosin stain (SL201), but instead 8 gm of using computer-assisted technology, per proposed direct PE inputs, with the eosin solution (SL063), and these are specimen; initial single probe stain addition of 1 minute of clinical labor not the same supply. Therefore we do procedure), 88368 (Morphometric time as detailed above for CPT code not agree that a direct comparison of the analysis, in situ hybridization 88321. We note as well that we are supply quantities is the most accurate (quantitative or semi-quantitative), finalizing the replacement of eosin way to value these procedures. For CPT manual, per specimen; initial single solution with eosin stain, as detailed in codes 88323 and 88325, we continue to probe stain procedure), 88369 the PE section of this final rule (see note that the prior supply inputs for (Morphometric analysis, in situ section II.A. of this final rule). these procedures had quantity 2.4 of the hybridization (quantitative or semi- eosin solution (SL063) and quantity 4.8 quantitative), manual, per specimen; (48) Immunohistochemistry (CPT Codes of the hematoxylin stain (SL135); in each additional single probe stain 88341, 88342, 88344, and 88350) other words, a 1:2 ratio between the procedure), 88373 (Morphometric In the CY 2014 PFS final rule with eosin and hematoxylin. We proposed to analysis, in situ hybridization comment period (78 FR 74341), we maintain that 1:2 ratio with 8 ml of the (quantitative or semi-quantitative), assigned a status indicator of I (Not eosin stain (SL201) and 16 ml of the using computer-assisted technology, per valid for Medicare purposes) to CPT hematoxylin stain (SL135). specimen; each additional single probe codes 88342 and 88343 and instead stain procedure), 88374 (Morphometric We also proposed to update the use of created two G-codes, G0461 and G0462, analysis, in situ hybridization the eosin solution (sometimes listed as to report immunohistochemistry (quantitative or semi-quantitative), ‘‘eosin y’’) in our supply database. We services. We did this, in part, to avoid using computer-assisted technology, per believe that the eosin solution supply creating incentives for overutilization. specimen; each multiplex probe stain (SL063), which is measured in grams, For CY 2015, the CPT coding was procedure), 88377 (Morphometric revised with the creation of two new reflects an older process of creating analysis, in situ hybridization eosin stains by hand. This is in contrast (quantitative or semi-quantitative), CPT codes, 88341 and 88344, the to the eosin stain supply (SL201), which manual, per specimen; each multiplex revision of CPT code 88342 and the is measured in milliliters, and can be probe stain procedure), and G0416 deletion of CPT code 88343. In the past ordered in a state that is ready for (Surgical pathology, gross and for similar procedures in this family, the staining immediately. We do not believe microscopic examinations, for prostate RUC recommended a work RVU for the that the use of eosin solution would needle biopsy, any method). add-on code (CPT code 88364) that was reflect typical lab practice today, with The following is a summary of the 60 percent of the work RVU for the base the readily availability for purchase of comments we received regarding our code (CPT code 88365). In the CY 2015 inexpensive eosin staining materials. proposed valuation of the Microslide PFS final rule with comment period, we We also note that in the CY 2016 PFS Consultation codes. stated that the relative resources final rule with comment period, we Comment: One commenter supported involved in furnishing an add-on removed 8 gm of the eosin solution and the restoration of the direct PE inputs service in this family would be reflected replaced it with 8 ml of the eosin stain, related to slide preparation in CPT code appropriately using the same 60 percent and this substitution was accepted 88325 and requested that CMS update metric and subsequently established an without further change in the most the PE data files for CY 2016 to reflect interim final work RVU of 0.42 for CPT recent set of RUC recommendations. As these changes. code 88341, which was 60 percent of a result, we proposed to update the Response: We appreciate the support the work RVU of 0.70 for the base CPT price of the eosin stain supply from from the commenter. The proposed rates code 88342. In the CY 2016 PFS $0.044 per ml to $0.068 per ml to reflect for CY 2017 reflected these changes to proposed rule, we revised the add-on the current cost of the supply. We also the direct PE inputs. However, the RVUs codes from 60 percent to 76 percent of proposed to use CPT codes 88323 and for CY 2016 were unaffected by this the base code and subsequently 88325 as a model, and replace the use proposal, as has been our longstanding proposed a work RVU of 0.53 for CPT of eosin solution with an equal quantity practice for interim final codes. code 88341. However, we inadvertently of eosin stain for the rest of the codes Comment: Several commenters published work RVUs for CPT code that make use of this supply. This requested that CMS add an additional 1 88341 in Addendum B on the CMS Web applies to 15 other CPT codes: 88302 minute for the clinical labor activity site without explicitly discussing it in (Level II—Surgical pathology, gross and ‘‘Complete workload recording logs. the preamble text. In the CY 2016 PFS microscopic examination), 88304 (Level Collate slides and paperwork. Deliver to final rule with comment period, we III—Surgical pathology, gross and pathologist’’ in CPT code 88321. maintained the CY 2015 work RVU of microscopic examination), 88305 (Level Commenters stated that this clinical 0.53 for CPT code 88341 as interim final IV—Surgical pathology, gross and labor task was accidently left off of the for CY 2016 and requested public microscopic examination), 88307 (Level April 2014 RUC recommendation for comment. Also, in the CY 2016 PFS V—Surgical pathology, gross and CPT code 88321, and that it was a final rule with comment period, we

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established an interim final work RVU stated the reduced reimbursement public comments, as we value these of 0.70 for CPT codes 88342 and 88344. would force pathologists to decrease the services through future notice and Comment on the CY 2016 PFS final number of technical staff, which would comment rulemaking. We also note that rule with comment period: Several interfere with pathologists’ ability to the PFS is a relative value system and, commenters objected to a standard perform these services accurately and as such, values services across all discount for the physician work timely. specialties. We believe it is important involved in pathology add-on services The RUC stated the CY 2017 proposed that there are accurate comparisons and urged us to accept the RUC- work RVUs for CPT codes 88341 and between codes in different families. recommend work RVU of 0.65 for CPT 88350 do not represent the work As discussed in detail in previous code 88341. involved in furnishing the procedure proposed and final rules, we continue to Response in the CY 2017 PFS and present a rank order anomaly for believe the metric we use to value add- proposed rule: We responded to the other services. The RUC also stated that on codes relative to their base codes is comments by stating our appreciation of the services furnished by CPT codes appropriate and representative of the the commenters’ concerns regarding a 37252 and 37253, which we used to work involved and note that there is no standard discount; however, we establish the relationship between the rank order anomaly within this believed that it was reasonable to base code and the add-on code, are not particular code family. In response to estimate work RVUs for a base and an medically comparable services to CPT the commenter’s statement that there add-on code, and to recognize codes 88341 and 88350. Additionally, should be no comparison of efficiencies between them, by looking at the RUC stated each pathology service intravascular ultrasound services to any how similar efficiencies are reflected in has individual intensities and pathology service, we continue to work RVUs for other PFS services. Also complexities. Specifically, for believe any difference in work RVUs for we noted that the intravascular codes additional immunohistochemistry codes describing different kinds of for which we initially established our services represented by add-on CPT services should reflect the relative base/add-on code relationship for CPT codes 88341 and 88350, each antibody differences in time and intensity codes 88346 and 88350 were deleted in is evaluated separately on different involved in furnishing the services. CY 2016 and replaced with two new slides and each additional service is Therefore, we believe that it is codes; CPT codes 37252 and 37253. The separate and distinct. imperative that we can compare the relationship between CPT codes 37252 Lastly, the RUC stated its approach of assumptions regarding overall work and 37253 represents a 20 percent evaluating the actual work associated between any two codes, regardless of discount for the add-on code as the base with each unique base and each unique their characteristics. CPT code 37252 has a work RVU of 1.80 add-on service is far more accurate, We appreciate commenters’ concerns and CPT code 37253 has a work RVU of rational, and responsive to the specific regarding a standard discount, and we 1.44. As CPT codes 37252 and 37253 circumstances than holding codes equal do not consider the use of a particular replaced the codes on which our to a fixed discount from the base code. increment to establish a new standard. discounts for base and add-on codes Applying ratio comparisons and fixed Instead, we reiterate that we believe that were based (please see the CY 2016 PFS discounts to arrive at a work relative it is reasonable to estimate work RVUs final rule with comment period (80 FR value will continue to create inter- for a base and an add-on code, and to 70972) for a detailed discussion), we specialty rank order anomalies of recognize efficiencies between them, by believed it would be appropriate to physician work RVUs. looking at how similar efficiencies are maintain the same 20 percent Another commenter noted there were reflected in work RVUs for other PFS relationship for CPT codes 88346 and RUC surveys that evaluated physician services. We appreciate the commenters’ 88350. Therefore, for CY 2017, we work differentials between the base concerns regarding the time ratio proposed a work RVU of 0.56 for CPT codes and the add-on codes for methodologies and have responded to code 88341, which represents 80 pathology services. The commenter these concerns about our methodology percent of the work RVU of 0.70 for the offered CPT codes 88333 (Pathology in section II.L of this final rule. base code. For CY 2016, we finalized a consultation during surgery; cytologic Therefore, for CY 2017 we are work RVU of 0.56 for CPT code 88350 examination (e.g., touch prep, squash finalizing a work RVU of 0.56, 0.70, which, represented 76 percent of the prep), initial site) and 88334 (Pathology 0.70, and 0.59 for CPT codes 88341, work RVU of 0.74 for the base code. To consultation during surgery; cytologic 88342, 88344 and 88350, respectively. maintain consistency within this code examination (e.g., touch prep, squash (49) Morphometric Analysis (CPT Codes family, for CY 2017 we proposed to prep), each additional site (List 88364, 88365, 88367, 88368, 88369 and revalue CPT code 88350 using the 20 separately in addition to code for 88373) percent discount discussed above. To primary procedure)) and CPT codes value CPT code 88350, we multiplied 88331 (Pathology consultation during For CY 2015, the CPT Editorial Panel the work RVU of 0.74 for CPT code surgery; first tissue block, with frozen revised the code descriptors for the in 88346 by 80 percent, and then section(s), single specimen) and 88332 situ hybridization procedures, CPT subtracted the product from 0.74, (Pathology consultation during surgery; codes 88365, 88367 and 88368, to resulting in a work RVU of 0.59 for CPT each additional tissue block with frozen specify ‘‘each separately identifiable code 88350. For CY 2017, we proposed section(s) (List separately in addition to probe per block.’’ Additionally, three a work RVU of 0.59 for CPT code 88350. code for primary procedure) as new add-on codes (CPT codes 88364, The following is a summary of the examples for consideration. 88369 and 88373) were created to comments we received regarding our Response: We appreciate commenters’ specify ‘‘each additional separately proposed valuations for the concern regarding the level of identifiable probe per slide.’’ Some of Immunohistochemistry family: reimbursement and will continue to the add-on codes in this family had Comments: Several commenters consider input from the medical RUC-recommended work RVUs that stated concerns regarding the level of community on this issue through were 60 percent of the work RVU of the reimbursement these pathology codes evaluation of CPT coding changes and base procedure. We believed this would receive if CMS reduced the work associated RUC recommendations, as accurately reflected the resources used RVUs as proposed. The commenters well as feedback received through in furnishing these add-on codes and

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subsequently established interim final codes 88364 and 88369 which corresponding interpretative diagnosis work RVUs of 0.53 for CPT code 88364 represents a 20 percent discount from has been made. (60 percent of the work RVU of CPT the base code. As the relationship The same commenter stated for code 88365); 0.53 for CPT code 88369 between the base code and add-on code morphometric codes, the pathologist is (60 percent of the work RVU of CPT now represents a 20 percent difference reviewing a second, unique and distinct code 88368); and 0.43 for CPT code we are proposing to revalue CPT code probe with an entirely different signal 88373 (60 percent of the work RVU of 88373 at 0.58 work RVUs. than that of its base code, and the work CPT code 88367). In the CY 2017 proposed rule, we involved with these add-on services For CY 2016, the RUC re-reviewed proposed a work RVU of 0.58 for CPT requires the same level of intensity and these services due to the specialty code 88373. time as their base codes. society’s initially low survey response The following is a summary of the The commenter also stated that rate. In our review of these codes, we comments we received regarding our pathology consultation and noticed that the latest RUC proposed valuation of the Morphometric cytopathology evaluation codes were recommendation was identical to the Analysis codes: clinically different and are not valid RUC recommendation provided for CY Comments: The RUC stated proxies to identify efficiencies for the 2015. Therefore, we proposed to retain appreciation for the proposed increase new add-on codes. Response: We do not agree that there the CY 2015 work RVUs and work time in work RVUs for CPT codes 88364 and are rank order anomalies within this for CPT codes 88367 and 88368 for CY 88369 although it stated the increase code family, and we note that this code 2016. For CPT code 88365 we finalized still does not represent the proper work family was valued within itself and not a work RVU of 0.88 for CY 2016. For RVU for the work involved and presents in relation to other services within the CPT codes 88364 and 88369, we a rank order anomaly relative to other PFS. In response to the commenter’s increased the work RVUs for both of services. The RUC, along with other statement that there should be no these add-on codes from 0.53 to 0.67, commenters, stated the services comparison of intravascular ultrasound which reflected 76 percent of the work described by CPT codes 37252 and services to any pathology service as RVUs of the base procedures for these 37253 are not comparable medical discussed above, we continue to believe services. However, we inadvertently services to those furnished by CPT it is valid to compare services across the omitted the rationale for this revision to codes 88364 and 88369, and there PFS when determining appropriate the work RVUs in the preamble to CY should be no comparison of 2016 proposed rule. Consequently, we values. intravascular ultrasound services to any maintained the CY 2015 interim final We also continue to believe that it is pathology services. values of the work RVU of 0.67 for CPT reasonable to recognize efficiencies The RUC also stated that although codes 88464 and 88369 and sought between them a base and an add-on some medical procedures and services comment on these values for CY 2016. code. In reviewing the RUC- may present efficiencies between base For CPT code 88373 we finalized a work recommended base/add-on and add-on services, this is not the case RVU of 0.43. relationships between several pathology Comment on the CY 2016 PFS final for CPT codes 88364 and 88369, as each codes, we continue to believe the base/ rule with comment period: A few pathology service is individual so that add-on code time relationships for commenters stated their objection to our any rational comparison of the pathology services are appropriate and use of a standard discount for pathology physician work of intravascular have not been presented with any add-on services and for suggesting that ultrasound services with pathology persuasive evidence or rationale that each service is separate and unique. services is impossible. The RUC also conflicts with the RUC-recommended Commenters also stated there should be stated that no pathology add-on service relationships. no comparison of intravascular can be presumed to have a discount in We agree with the commenter that the ultrasound services to morphometric physician work from the base service. designation ‘‘add-on’’ does not analysis, immunohistochemistry, Another commenter stated for CPT automatically imply a reduction; immunofluorescence, or any pathology code 88373, it is irrational to assume however, in the case of these similar service. that second and subsequent services pathology services, we continue to Response in the CY 2017 PFS designated by convention as ‘‘add-on’’ believe using the same valuation metrics proposed rule: In reviewing the RUC services require a reduction in resources is valid. Therefore, for CY 2017, we are recommended base/add-on relative to the corresponding initial finalizing a work RVU of 0.70, 0.73, relationships between several pathology service. 0.88, 0.70 and 0.58 for CPT codes 88364, codes, we continue to believe the base/ Another commenter noted that in the 88367, 88368, 88369 and 88373, add-on code time relationships for CY 2017 proposed rule, CMS incorrectly respectively. pathology services are appropriate and stated it was utilizing a RUC have not been presented with any recommendation specific to these codes. (50) Liver Elastography (CPT Code compelling evidence that conflicts with According to the CY 2015 Final Rule (79 91200) the RUC-recommended relationships. FR 67548), the codes on which CMS For CY 2016, we received a RUC However, as we stated above, the based its discount were CPT codes recommendation of 0.27 work RVUs for intravascular codes we initially 88334, 88335, 88177, and 88172. The CPT code 91200. After careful review of examined in revaluing CPT codes 88364 commenter states the distinction the recommendation, we established the and 88369 were deleted in CY 2016 and between the codes cited in the CY 2015 RUC-recommended work RVU and replaced with CPT codes 37252 and final rule, CPT codes 88334, 88335, direct PE inputs as interim final for CY 37253. For the reasons stated above we 88177, 88172, and the new add-on 2016. continue to believe this 20 percent codes, CPT codes 88364, 88369 and Comment on the CY 2016 PFS final discount relationship between the base 88373, is that the discount factor is rule with comment period: A few and add-on code accurately reflects the specific to services for which a commenters requested that we work involved in furnishing these diagnosis has already been furnished. reconsider the level of payment services. Therefore, for CY 2017, we are For the new codes to which CMS assigned to this service when furnished proposing a work RVU of 0.70 for CPT applied this discount, no such in a nonfacility setting, stating that the

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code met the definition for the The following is a summary of the maintenance costs, as equipment potentially misvalued code list as there comments we received regarding our maintenance costs are built into the is a significant difference in payment proposed valuation of CPT code 91200. equipment cost per minute formula. We between sites of service. The Comment: Many commenters are also changing the name of ER101 commenters also asked us to reconsider disagreed with the proposed valuation from ‘‘Fibroscan’’ to ‘‘Fibroscan with the assigned 50 percent utilization rate of CPT code 91200, suggesting that the printer’’ to reflect the fact that this for the FibroScan equipment in this $34 payment rate in the nonfacility pricing incorporates a printer. procedure as the current utilization rate setting for CY 2016 underestimated the After consideration of comments would translate to over 50 procedures resource cost of the procedure. received, we are finalizing our proposed per week. Instead, the commenters Commenters stated that this code is a work RVUs and direct PE inputs, with suggested the typical number of first-line method used to assess fibrosis the price increase to the Fibroscan with procedures done per week ranges scores in patients with chronic liver printer equipment. disease, especially those with chronic between 15 and 25 and requested we (51) Closure of Paravalvular Leak (CPT Hepatitis C, and that the current adopt a 25 percent utilization rate Codes 93590, 93591, and 93592) reimbursement was not sufficient to which corresponds to that number of cover the cost of providing the service. The CPT Editorial Panel developed procedures. Some commenters compared the use of three new codes (two base codes and Response in the CY 2017 PFS the Fibroscan device in CPT code 91200 one add-on code) to describe proposed rule: We refer commenters to to more expensive and more invasive paravalvular leak closure procedures the CY 2016 final rule with comment liver biopsies, or compared the cost of that were previously reported using an period (80 FR 71057–71058) where we the procedure to the treatment provided unlisted code. The RUC recommended a discussed and addressed the in hospital-based payment systems. work RVU of 17.97 for CPT code 93591. comparison of the PFS payment amount Commenters urged CMS to increase the We proposed a work RVU of 14.50 for to the OPPS payment amount for CPT valuation of CPT code 91200 to CPT code 93591, a direct crosswalk 91200. For the commenter’s statement encourage providers to adopt the use of from CPT code 37227. We stated in the about the utilization rate, we have the Fibroscan device. CY 2017 proposed rule that we believe previously addressed the accuracy of Response: We remind commenters that a direct crosswalk to CPT code these default assumptions as they apply that we are obligated by statute to set 37227 accurately reflected the time and to particular equipment resources and payment rates based on the resources intensity described in CPT code 93591 particular services. In the CY 2008 PFS used to furnish the procedure, and that since CPT code 37227 also described a proposed rule (72 FR 38132), we as a result pricing for codes on the PFS transcatheter procedure with similar discussed the 50 percent utilization does not necessarily mirror pricing for service times. To maintain relativity among the assumption and acknowledged that the codes under different payment systems. codes in this family, we proposed default 50 percent usage assumption is We also note that we proposed the RUC- refinements to the recommended work unlikely to capture the actual usage recommended work RVU and direct PE RVUs for CPT code 93590. The RUC rates for all equipment. However, we inputs for CPT code 91200 without noted that the additional work stated that we did not believe that we alteration. Comment: Many of the commenters associated with CPT code 93590 had strong empirical evidence to also addressed the pricing of the compared to CPT code 93591 was due support any alternative approaches. We Fibroscan equipment (ER101). to the addition of a transseptal puncture indicated that we would continue to Commenters provided CMS a range of to access the mitral valve. The RUC monitor the appropriateness of the different prices for this equipment item, identified a work RVU of 3.73 for a equipment utilization assumption, and individually suggesting that the transseptal puncture. Therefore, for CPT evaluate whether changes should be equipment costs $120k, $130k, $140k, code 93590, we proposed a work RVU proposed in light of the data available. and $150k. One commenter supplied an of 18.23 by using our proposed work The commenters did not provide any individual invoice for the Fibroscan, RVU of 14.50 for CPT code 93591 and verifiable data suggesting a lower including the device itself along with a adding the value of a transseptal utilization rate. Therefore, for CY 2017 CAP option, an S probe, a printer, and puncture (3.73). we proposed a work RVU of 0.27 for shipping/maintenance costs. CPT code 93592 is an add-on code CPT code 91200, consistent with the CY Response: We appreciate the used to report placement of additional 2016 interim final value, and we submission of additional information occlusion devices for percutaneous continued to explore and solicit regarding the proper pricing of the transcatheter paravalvular leak closure, comments regarding publically available Fibroscan. We encourage more performed in conjunction with either an data sources to identify the most commenters to include invoices with initial mitral or aortic paravalvular leak accurate equipment utilization rate their comment submissions if they closure. The RUC recommended a work assumptions possible. We also noted believe that existing supplies or RVU of 8.00 for this code. In the that following the publication of the CY equipment items are undervalued, as we proposed rule, we stated that we 2016 PFS final rule with comment have had longstanding reservations considered applying the relative period (80 FR 70886) there was an about establishing pricing based on increment between CPT codes 93590 inconsistency in the Work Time file single invoices. In the specific case of and 93591; however, we believed that a published on the CMS Web site. For the Fibroscan equipment, we agree that direct crosswalk to CPT code 35572, CPT code 91200 the RUC recommended the price should be increased based on with a work RVU of 6.81, more 16 minutes total service time whereas the submitted invoice. We are pricing accurately reflected the time and our file reflected 18 minutes total time ER101 at $183,390 based on a intensity of furnishing the service. for the service. For CY 2017, we combination of the cost of the Fibroscan Therefore, for CPT code 93592, we proposed to update the Work Time file itself ($131,950), the CAP option proposed a work RVU of 6.81. to reflect the RUC’s recommendation, ($22,955), the S probe ($27,950), and the Comment: For CPT code 93591, which is 16 minutes for CPT code printer ($495). We note that we do not commenters opposed CMS’ assertion 91200. typically pay for shipping costs or that a cardiovascular intervention

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performed in an immobile leg is to use the RUC-recommended work documentation, per standardized comparable in intensity and patient risk RVUs for CPT codes 95812 and 95813. instrument) and 96161 (Administration to an intervention performed in a In the CY 2016 PFS final rule with of caregiver-focused health risk beating, moving heart. Commenters comment period (80 FR 70886), we assessment instrument (e.g., depression suggested that CMS’ proposed crosswalk finalized direct PE input refinements for inventory) for the benefit of the patient, to CPT code 37227 was not appropriate several clinical labor times for CPT with scoring and documentation, per since CPT code 37227 is generally codes 95812 and 95813. The RUC’s standardized instrument). For CPT code performed in an outpatient setting, February 2016 direct PE summary of 96160, we proposed the RUC- while CPT code 93591 is generally recommendations indicated that the recommended direct PE inputs. For CPT performed in a facility setting due to the specialty society expert panel disagreed code 96161, the service is furnished to intensity and risk associated with the with CMS’ refinements to clinical labor a patient who may not be a Medicare procedure. Subsequently, commenters time for these two codes. The RUC beneficiary, and therefore, we did not suggested that CMS finalize the RUC- recommended 62 minutes for clinical believe the code would be eligible for recommended work RVU of 17.97 for labor task ‘‘perform procedure’’ for CPT Medicare payment. We proposed to CPT code 93591. code 95812 and 96 minutes for the same assign a procedure status of I (Not valid For CPT code 93590, commenters, clinical labor task for CPT code 95813, for Medicare purposes) for CPT code including the RUC, supported CMS’ similar to the values recommended by 96161. proposed use of the same building block the RUC in April 2014. We noted that we believed that CPT methodology used in the RUC We proposed to maintain the CMS- code 96160 describes a service that is recommendations, by proposing to refined CY 2016 PE inputs for clinical frequently reasonable and necessary in apply a work RVU of 3.73 to the base labor task ‘‘perform procedure’’ for CPT the treatment of illness or injury, such code value of 93591. However, codes 95812 (50 minutes) and 95813 (80 as when there has been a change in commenters suggested that CMS apply minutes), since the RUC’s PE summary health status. However, when the the value of a transeptal puncture to the of recommendations stated that CPT service described by CPT code 96160 is RUC-recommended value for CPT code code 95812 required 50 minutes of explicitly included in another service 93591, and therefore, finalize the RUC- clinical labor time for EEG recording, being furnished, such as the Annual recommended work RVU of 21.70 for and CPT code 95813 required 80 Wellness Visit (AWV), this code should CPT code 93590. minutes of clinical labor time for the not be billed separately, much like other codes that describe services included in For CPT code 93592, commenters, same clinical labor task. codes with broader descriptions. We including the RUC, disagreed with CMS’ We did not receive any comments on our proposals for this family of codes. also noted that this service should not proposed comparison of CPT code be billed separately if furnished as a 93592 to CPT code 35572 (Harvest of Therefore, for CY 2017, we are finalizing our proposed direct PE inputs for these preventive service as it would describe femoropopliteal vein, 1 segment, for a non-covered service. However, we also vascular reconstruction procedure (e.g., codes without modifications. We are also finalizing for CY 2017 work RVUs solicited comment on whether this aortic valve services)). Commenters service may be better categorized as an stated that CMS’s proposed crosswalk is of 1.08 for CPT code 95812, 1.63 for CPT code 95813, 1.98 for CPT code 95957. add-on code and welcomed stakeholder inappropriate and does not recognize input regarding whether or not there are the intensity and skill level needed to (53) Analysis of Neurostimulator Pulse circumstances when this service might place a device to close a paravalvular Generator System (CPT Codes 95971, be furnished as a stand-alone service. leak in a moving, beating heart, 95972) Comment: Many commenters frequently in patients with heart failure. CPT codes 95971 and 95972 were recommended that CMS should Commenters stated that CPT code 35572 established as interim final following recognize and make separate payment was only similar to CPT code 93592 in the CY 2016 final rule with comment for CPT code 96160, as proposed, as that both procedures are cardiovascular period. For CY 2017, we proposed to well as 96161 using the RUC- in nature. Commenters also stated that maintain their work RVUs and direct PE recommended values. Several of these surgical harvest of the lower extremity inputs. commenters argued that the medical vein is not clinically similar to the Comment: A commenter expressed community has recognized that health transcatheter percutaneous structural support for the proposal to maintain the risk assessment of caregivers is an heart therapies. current work and PE RVUs, stating that integral part of ongoing medical care for Response: We thank the commenters these codes were revalued in 2015 and patients with particular needs. These for their feedback on our proposal. After there was no reason to make any commenters offered several examples consideration of the comments received, changes. where such an assessment is integral to we are finalizing the RUC-recommended Response: We appreciate the support treating patients, such as: work RVUs for each of the codes in this from the commenter. • Assessment of maternal depression family. Therefore, we are finalizing a After consideration of comments in the active care of infants, work RVU of 21.70 for CPT code 93590, received, we are finalizing our proposed • Assessment of parental mental a work RVU of 17.97 for CPT code work RVUs and proposed direct PE health as part of evaluating a child’s 93591, and a work RVU of 8.00 for CPT inputs for CPT codes 95971 and 95972. functioning, code 93592. • Assessment of caretaker conditions (54) Patient, Caregiver-focused Health as indicated where atypical parent/child (52) Electroencephalogram (EEG) (CPT Risk Assessment (CPT Codes 96160 and interactions are observed during care, Codes 95812, 95813, and 95957) 96161) • Assessment of caregivers as part of In February 2016, the RUC submitted In October 2015, the CPT Editorial care management for adults whose recommendations for work and direct Panel created two new PE-only CPT physical or cognitive status renders PE inputs for CPT codes 95812, 95813, codes, 96160 (Administration of patient- them incapable of independent living and 95957. We proposed to use the focused health risk assessment and dependent on another adult RUC-recommended physician work and instrument (e.g., health hazard caregiver. Some examples might be direct PE inputs for CPT code 95957 and appraisal) with scoring and intellectually disabled adults, seriously

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disabled military veterans and adults therefore, should be valued the same. We proposed to refine the service period with significant musculoskeletal or The RUC recommended a work RVU of clinical labor for ‘‘Other Clinical central nervous system impairments. 0.80 for CPT codes 96931 and 96933 Activity—Review imaging with Because commenters noted that these based on the 25th percentile of the interpreting physician’’ to zero minutes assessments were generally survey. Based on the similarity of the for CPT codes 96933 and 96936 as these administered during E/M services, they services being performed in CPT codes are interpretation and report only codes were receptive to making both CPT 96931 and 96933 and the identical intra- and not image acquisition. codes 96160 and 96161 add-on codes to service times of 96931, 96933 and Comment: Several commenters, E/M services. 88305, the key reference code from the including the RUC, objected to the Response: After considering survey, we believe a direct crosswalk proposed valuations for CPT codes comments, we believe that CPT codes from CPT code 88305 to CPT codes 96931, 96933, 96934, and 96936. The 96160 and 96161 describe services that, 96931 and 96933 would more accurately RUC disagreed with pre-service time in particular cases, can be necessary reflect the work involved in furnishing being removed from a survey code components of services furnished to the procedure. Therefore, for CY 2017, simply due to a key reference code not Medicare beneficiaries. While we we proposed a work RVU of 0.75 for also having pre-service time. The RUC recognize that in many cases we have CPT codes 96931 and 96933. In stated CPT codes 96931 and 96933 are previously assigned non-payment addition, we proposed removing 3 distinct procedures from CPT codes indicators to codes that describe minutes of preservice time from CPT 88305 and the CMS proposal to remove interactions with caregivers, we also codes 96931 and 96933 since it is not 3 minutes of pre-time from the base note that we have also recognized that included in CPT code 88305 and as a RCM codes was grounded on faulty in current medical practice, practitioner result, we did not believe it was logic. The RUC stated its agreement interaction with caregivers is an integral appropriate in CPT codes 96931 and with the specialty society that 3 minutes part of treatment for some patients. 96933. of preservice time was necessary for the Accordingly, the descriptions for several For CPT codes 96934 and 96936, the physician to review clinical history and payable codes under the PFS include specialty society and the RUC agreed referral information. The RUC further direct interactions between practitioners that the physician work required for stated with the 3 minutes of pre-service and caregivers. both codes were identical, and time in its recommendation for the RCM In developing our proposal regarding therefore, should be valued the same. In base codes were appropriately in line the payment disposition of this code, we its recommendation, the RUC stated that with top key reference CPT code 88305 noted that it singularly described a it believed the survey respondents and urged CMS to accept the survey service administered to a caregiver. somewhat overestimated the work for 25th percentile work RVUs for CPT However, based on public comments, CPT code 96934 with the 25th codes 96931, 96933, 96934, and 96936. including the receptivity to our percentile yielding a work RVU of 0.79. Other commenters stated there were assignment of add-on code status, we Consequently, the RUC reviewed the very significant differences in the understand that in actual practice, this survey results from CPT code 96936 and technologies used and the work service is integrated with E/M visits agreed that the 25th percentile work involved between the procedures of CPT under particular circumstances. RVU of 0.76 accurately accounted for code 88305, the key reference code, and Consequently, we believe the the work involved for the service. CPT codes 96931 and 96933, with CPT appropriate payment status for the code Therefore, the RUC recommended a codes 96931 and 96933 being more should be determined by looking at the work RVU of 0.76 for CPT codes 96934 complex procedures. overall service as described by the two and 96936. One commenter stated CMS codes together. We agree with We believe that the incremental incorrectly removed technician time for commenters, then, that there are difference between the RUC- ‘‘Other Clinical Activity—Review circumstances where this service is an recommended values for the base and imaging with interpreting physician’’ for essential part of a service to a Medicare add-on codes accurately captures the CPT codes 96933 and 96936 noting the beneficiary. Therefore, we are assigning difference in work between the code technician still must review the imaging an active payment status to both codes pairs. However, because we valued the with the interpreting physician and for CY 2017. We are also establishing base codes differently than the RUC, we urged CMS to accept the RUC use of the RUC recommended values for proposed values for the add-on codes recommendations. these codes. We are also assigning an that maintain the RUC’s 0.04 increment Response: After consideration of add-on code status to both of these instead of the RUC-recommended comments received, we agree with the services. As add-on codes, CPT codes values. Therefore we proposed a work commenters and will finalize the RUC- 96160 and 96161 describe additional RVU of 0.71 for CPT codes 96934 and recommended work RVUs of 0.80, 0.80, resource components of a broader 96936. 0.76, and 0.76 for CPT codes 96931, service furnished to the patient that are We also proposed to reduce the 96933, 96934 and 96936; respectively. not accounted for in the valuation of the preservice clinical labor for ‘‘Patient We will also restore the 3 minutes of base code. clinical information and questionnaire preservice time to CPT codes 96931 and reviewed by technologist, order from 96933. (55) Reflectance Confocal Microscopy physician confirmed and exam (CPT Codes 96931, 96932, 96933, 96934, protocoled by physician’’ for CPT codes (56) Evaluative Procedures for Physical 96935, and 96936) 96934 and 93936 as this work is Therapy and Occupational Therapy For CY 2015, the CPT Editorial Panel performed in the two base CPT codes (CPT Codes 97161, 97162, 97163, 97164, established six new Category I codes to 93931 and 93933. We proposed to 97165, 97166, 97167, 97168) describe reflectance confocal reduce the service period clinical labor For CY 2017, the CPT Editorial Panel microscopy (RCM) for imaging of skin. for ‘‘Prepare and position patient/ deleted four CPT codes (97001, 97002, For CPT codes 96931 and 96933, the monitor patient/set up IV’’ from 2 to 1 97003, and 97004) and created eight specialty society and the RUC agreed minute for CPT codes 93934 and 93936 new CPT codes (97161–97168) to that the physician work required for since we believed that less positioning describe the evaluative procedures both codes were identical, and time is needed with subsequent lesions. furnished by physical therapists and

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occupational therapists. There are three services were reported using each of the evaluations; and we also considered the new codes, stratified by complexity, to two new codes. If more than half of the evaluation services described by the replace a single CPT code 97001, for services were reported using the codes as a whole. The varying work physical therapy (PT) evaluation, and ‘‘simple’’ code, then there would be RVUs and the dependence on utilization three new codes, also stratified by fewer overall work RVUs. If more than for each complexity level to ensure complexity, to replace a single code CPT half of the services were reported using work neutrality in the PT and OT code code 97003, for occupational therapy the ‘‘complex’’ code, then there would families make it difficult for us evaluate (OT) evaluation, and one new code each be more overall work RVUs. Therefore, the HCPAC’s recommended values or to to replace the re-evaluation codes for work neutrality can only be assessed predict with a high degree of certainty physical and occupational therapy, CPT with an understanding of the relative whether physical and occupational codes 97002 and 97004. Table 23 frequency of how often particular codes therapists will actually bill for these includes the long descriptors and the will be reported. services at the same rate forecast by required components of each of the The HCPAC recommended a work their respective specialty societies. eight new CPT codes for the PT and OT RVU of 0.75 for CPT code 97161, a work We were concerned that the coding services. RVU of 1.18 for CPT code 97162, and a stratification in the PT and OT The CPT Editorial Panel’s creation of work RVU of 1.5 for CPT code 97163. evaluation codes may result in upcoding the new codes for PT and OT evaluative The PT specialty society projected that incentives, especially while physical procedures grew out of a CPT the moderate complexity evaluation and occupational therapists gain workgroup that was originally convened code would be reported 50 percent of familiarity and expertise in the in January 2012 when contemplating the time because it is the typical differential coding of the new PT and major revision of the Physical Medicine evaluation, and the CPT codes for the OT evaluation codes that now include and Rehabilitation CPT section of codes low and high complexity evaluations the typical face-to-face times and new in response to our nomination of are each expected to be billed 25 required components that are not therapy codes as potentially misvalued percent of the time. The HCPAC- enumerated in the current codes. We codes, including CPT code 97001 (and, recommended work RVU of 1.18 for were also concerned that stratified as a result, all four codes in the family) CPT code 97162 represents the survey payment rates may provide, in some in the CY 2012 PFS proposed rule. median with 30 minutes of intraservice cases, a payment incentive to therapists In reviewing the eight new CPT codes time, 10 minutes of preservice time, and to upcode to a higher complexity level for evaluative procedures, the HCPAC 15 minutes postservice time. The than was actually furnished to receive a forwarded recommendations for work HCPAC notes this work value is higher payment. RVUs and direct PE inputs for each appropriately ranked between levels 2 We understood that there may be code. Currently, CPT codes 97001 and and 3 of the E/M office visit codes for multiple reasons for the CPT Editorial 97003 both have a work RVU of 1.20, new patients. Panel to stratify coding for OT and PT and CPT codes 97002 and 97004 both The HCPAC recommended a work evaluation codes based on complexity. have a work RVU of 0.60. These CPT RVU of 0.88 for CPT code 97165, a work We also noted that the codes will be codes have reflected the same work RVU of 1.20 for CPT code 97166, and a used by payers in addition to Medicare, RVUs since CY 1998 when we accepted work RVU of 1.70 for CPT code 97167. and other payers may have direct the HCPAC values during CY 1998 For the OT codes, work neutrality interest in making such differential rulemaking. would be achieved only with a payment based on complexity of OT and projected utilization in which the low PT evaluation. Given our concerns i. Valuation of Evaluation Codes complexity evaluation is billed 50 regarding appropriate valuation, work In the CY 2017 PFS proposed rule, we percent of the time; the moderate neutrality, and potential upcoding, noted that the HCPAC submitted work complexity evaluation is billed 40 however, we did not believe that RVU recommendations for each of the percent of the time, and the high making different payment based on the six new PT and OT evaluation codes. complexity evaluation only billed 10 reported complexity for these services These recommendations are intended to percent of the time. For purposes of is, at current, advantageous for Medicare be work neutral relative to the valuation calculating work neutrality, the HCPAC or Medicare beneficiaries. for the previous single evaluation code recommended assuming that the low Given the advantages inherent and for PT and OT, respectively. However, complexity code will be most frequently public interest in using CPT codes once that assessment for each family of codes reported even though the HCPAC- they become part of the code set, we is dependent on the accuracy of the recommended work RVU of 1.20 and 45 proposed to adopt the new CPT codes utilization forecast for the different minutes of intraservice time for for use in Medicare for CY 2017. complexity levels within the PT or OT moderate complexity code is identical However, given our concerns about family. As used in this section, work to that of the current OT evaluation appropriate pricing and payment for the neutrality is distinct from the budget code. The HCPAC believes that the work stratified services, we proposed to price neutrality that is applied broadly in the RVU of 1.20 is appropriately ranked the services described by these stratified PFS. Specifically, work neutrality is between 99202 and 99203, levels 2 and codes as a group instead of individually. intended to reflect that despite changes 3 for E/M office visits for new To do that, we proposed to utilize the in coding, the overall amount of work outpatients. authority in section 220(f) of the RVUs for a set of services is held Protecting Access to Medicare Act constant from one year to the next. For ii. Valuation of Evaluation Codes and (PAMA), which revised section example, if a service is reported using Discussion of PAMA 1848(c)(2)(C) of the Act to authorize the a single code with a work RVU of 2.0 In our review of the HCPAC Secretary to determine RVUs for groups for one year but that same service would recommendations, we noted the work of services, rather than determining be reported using two codes, one for neutrality and the inherent reliance on RVUs at the individual service level. We ‘‘simple’’ and another for ‘‘complex’’ in the utilization assumptions. We believed that using this authority the subsequent year valued at 1.0 and considered the three complexity levels instead of proposing to make payment 3.0 respectively, work neutrality could for the PT evaluations and the three based on Medicare G-codes will only be attained if exactly half the complexity levels for the OT preserve consistency in the code set

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across payers, thus lessening burden on specific equipment item, but we 99213, levels 2 and 3 E/M office-visit providers, while retaining flexibilities solicited comment regarding the paper’s codes for established patients. that are beneficial to Medicare. use. The HCPAC provided a work RVU of We proposed a work RVU of 1.20 for For the OT evaluation codes, we 0.80 for the OT re-evaluation code, CPT both the PT and the OT evaluation considered proposing to use the direct code 97168, based on the 25th groups of services. We proposed this PE inputs for the low complexity percentile of the survey, which work RVU because we believed it best evaluation because the OT specialty represents an increase over the current represents the typical PT and OT organization believes it represents the work RVU of 0.60 for CPT code 97004. evaluation. This is the value typical OT evaluation service with a This work value includes 30 minutes of recommended by the HCPAC for the OT projected 50 percent utilization rate. intraservice time, 5 minutes preservice moderate complexity evaluation and However, we proposed to use the time, and 10 minutes immediate nearly the same work RVU for moderate-level direct inputs instead, postservice time. The HCPAC noted that corresponding PT evaluation (1.18). because the direct PE for this level is the increase in work compared to the PT Additionally, a work RVU of 1.20 is the based on a vignette that is valued with re-evaluation code (0.75) is because the long-standing value for the current the same intraservice time, 45 minutes, occupational therapist spends more evaluation codes, CPT codes 97001 and as the current code, CPT code 97003. time observing and assessing the patient 97003, and thus, assures work neutrality Consequently, we proposed to use the and, in general, the OT patient typically without reliance on particular recommended direct PE inputs for the has more functional and cognitive assumptions about utilization, which moderate complexity code for use in disabilities. The HCPAC we believed was the intent of the developing PE RVUs for this group of recommendation notes that the 0.80 HCPAC recommendation. services. work RVU recommendation Because we proposed to use the same appropriately ranks it between the level Our proposed direct PE inputs reflect work RVU for the six evaluation codes, 1 and 2 E/M office-visit codes for new the recommended values minus 2 we are not addressing any additional patients. concerns about the utilization minutes of occupational therapist The HCPAC’s recommended increases assumptions recommended to us. assistant (OTA) time in the service to work RVUs for the PT and OT re- Because we proposed the same work period because we believe that OTA evaluation codes are not work neutral. values for each code in the family, there tasks to administer certain assessment We are unclear why the HCPAC did not will be no ratesetting impact to work tools are appropriately included as part maintain work neutrality for the OT and neutrality. As such, we are not revising of the occupational therapist’s work and PT re-evaluation codes since the utilization crosswalks as projected the time of the OTA to explain and maintaining work neutrality was by the respective therapy specialties to score self-reported outcome measures is important to the establishment of the six achieve work neutrality. However, were not separately included in the clinical new evaluation codes. We proposed to we to value each code in the PT or OT labor of other codes. We also rounded maintain the overall work RVUs for evaluation families individually, we up the recommended 6.8 minutes to 7 these services by proposing a work RVU would seek objective data from minutes to represent the time the OTA of 0.60 for CPT codes 97164 and 97168, stakeholders to support the utilization assists the occupational therapist during consistent with the work RVUs for the crosswalks, particularly those for the OT the intraservice time period. For the deleted re-evaluation codes. We family in which the low-level Vision Kit equipment item, our solicited comments from stakeholders complexity evaluation is depicted as proposed price reflects the submitted on whether there are reasons that the re- typical and the high complexity is invoice that clearly defined a kit. evaluation codes should be revalued projected to be billed infrequently at 10 iii. Valuation of Re-evaluation Codes without regard to work neutrality. percent of the overall number of OT We proposed the HCPAC- evaluations. The recommendations the HCPAC recommended direct PE inputs for CPT We proposed to use the direct PE sent to us for the PT and OT re- code 97164 with a reduction in time for inputs forwarded by the HCPAC (with evaluation codes are not work neutral. the PTA by 1 minute (from 5 to 4) in the the refinements described below) for the For the new PT re-evaluation code, CPT service period—the line for ‘‘Other moderate complexity PT and OT code 97164, the HCPAC recommended Clinical Activity’’—because the time to evaluations in the development of PE a work RVU of 0.75 compared to the explain and score the self-reported RVUs for the PT and OT codes as a work RVU of 0.60 for CPT code 97002. outcome measure (for example, group of services. For the PT codes, we This recommended work RVU falls Oswestry) is not separately included in proposed to use the recommended between the 25th percentile of the the clinical labor of other codes. inputs for the moderate complexity code survey and the survey’s median value We proposed the HCPAC- for the direct PE inputs of all three and was based on a direct crosswalk to recommended direct PE inputs for CPT codes based on its assumption as the CPT code 95992 for canalith code 97168 with a reduction in time for typical service. Our proposed direct PE repositioning with 20 minutes the OTA by 1 minute (from 3 to 2) in inputs reflect the recommended values intraservice time and 10 minutes the service period—the line for ‘‘Other minus 2 minutes of physical therapist immediate postservice time. The Clinical Activity’’—for the same reason assistant (PTA) time in the service HCPAC supported this 0.15 work RVU we proposed to reduce the period because we believe that PTA increase based on an anomalous corresponding line for PTAs—because tasks to administer certain assessment relationship between PT services and E/ the time to explain and score any tools are appropriately included as part M office visit codes for established patient-self-administered functional and of the physical therapist’s work and the patients, noting that physician E/M other standardized outcome measure is time of the PTA to explain and score codes have historically been used as a not separately included in the clinical self-reported outcome measures is not relative comparison. The HCPAC stated labor of other codes. separately included in the clinical labor its recommendation of a work RVU of Because the new CPT code of other codes. We proposed to include 0.75 for CPT code 97164 appropriately descriptors contain new coding the recommended four sheets of laser ranks it between the key reference codes requirements for each complexity level, paper without an association to a for this service, CPT codes 99212 and we solicited comment from the PT and

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OT specialty organizations, as well as includes reliable and valid outcome and evaluations were not. The HCPAC other stakeholders to clarify how quality measures to demonstrate the requested that we consider the therapists will be educated to outcome and value of therapy. difference in PT services versus OT distinguish the required complexity Response: We thank the commenters services. level components and the selection of for voicing their concerns about our Some commenters presumed that our the number of elements that impact the adoption of the new CPT codes for PT proposal to value the work the same for plan of care. For example, for the OT and OT evaluative procedures and their each evaluation complexity level was codes, we invited comment on how to alternative coding suggestions. temporary. Another commenter define performance deficits, what However, we note that we do not have expressed hope that we did not intend process the occupational therapist uses the authority to change CPT code to equally value the PT high complexity to identify the number of these descriptors or use deleted codes without evaluation the same as the low performance deficits that result in creating G-codes to do so. We also note complexity one in perpetuity. Several activity limitations, and performance that adopting a demonstration or pilot commenters requested that CMS factors needed for each complexity program is not a typical CMS payment describe our future plans to revisit these level. For the PT codes, we sought more policy response to the creation of new code sets and asked that the future information about how the physical CPT codes or code sets. After proposal for these payment amounts be therapist differentiates the number of considering these comments, we subject to public comment. One of these personal factors that actually affect the continue to believe that our proposal to commenters that favored keeping the plan of care. We were also interested in adopt the eight new CPT codes for use current code structure urged us not to understanding more about how the in Medicare for CY 2017, rather than adopt the new CPT codes until we are physical therapist selects the number of retain the current coding structure by ready to differentiate payments based on elements from any of the body creating G-codes, is the best option the complexity of the provided service. structures and functions, activity given the advantages inherent and Some commenters told us that our limitations, and participation public interest in using the CPT codes lack of payment stratification for the restrictions to make sure there is no once they become part of the code set. three PT and three OT evaluation codes duplication during the physical As such, we are finalizing our proposal would likely prompt coding and billing therapist’s examination of body systems. to adopt new CPT codes 97161–97168 behavioral change by some therapists The following is summary of the for PT and OT evaluations and re- and other providers of therapy services. comments we received: evaluations. One of these commenters claimed that Comment: Several commenters Comment: Many commenters objected assigning the same work RVU to each disagreed with our proposal to accept to our proposal to use the PAMA evaluation complexity level would the new CPT codes for PT and OT authority to price the services described cause some providers not to adhere to evaluations and re-evaluations and by the stratified sets of PT and OT the new coding stratification which urged us to keep the current four-code evaluation codes as a group instead of could result in inaccurate data on the set. A few of these commenters noted individually and asked us to accept or levels being reported. Another our proposal to accept the stratified consider the HCPAC work RVU values commenter stated that the lack of code sets for PT and OT evaluations for each of these six evaluation services. payment stratification to reflect the would increase the administrative Some commenters expressed concern therapist’s time and expertise at each burden associated with documentation that we ignored the HCPAC complexity level could signal to and education training of therapists, recommendations and proposed to therapists that the accurate coding of billers and coders. Other commenters maintain the work RVU of 1.20, since evaluations is of diminished interest to believed that CMS should first the codes have not been reviewed for CMS. Other commenters stated that the implement the new complexity-defined this purposes in nearly 20 years. Other failure to recognize payment CPT code set on a demonstration or commenters stated that CMS, by valuing stratification between the complexity pilot project basis before we apply it the PT and OT evaluation complexity levels would be detrimental to patient nationally. One commenter proposed levels with the same work RVUs, was care and the practice of therapy, for that, rather than accepting the new CPT failing to appropriately align cost and example, by reducing incentives for eight-code set with varying descriptors quality as mandated in the ACA and therapists to thoroughly evaluate for each PT and OT complexity level, MACRA. patients with multiple and complex we adopt just two codes that both the Because we proposed the same conditions who fall into the high PT and OT disciplines could use: a code values, a few commenters were complexity evaluation. for PT/OT evaluation and another for concerned that we failed to discuss the Response: After a review of the PT/OT re-evaluation. Another difference in the PT and OT evaluation comments, we continue to believe that commenter told us that services. These commenters told us that using the PAMA RVU authority to value ‘‘implementation of the complex the HCPAC recommendations included the PT and OT evaluation codes as a scheme for determining the evaluation higher work RVUs for the OT services group of services is appropriate. Given level will excessively complicate patient because they reflected greater our concerns about appropriate pricing evaluations where clinicians will intraservice times from the surveys, and and payment for the PT and OT require more mental effort to meet the these times led, in part, to the HCPAC’s stratified evaluation services as demands of the documentation with less belief that the typical patient receiving described in the CY 2017 proposed rule, time and attention directed at treating OT services is more complex and we are finalizing our proposal to use the the patient.’’ One commenter suggested intense to treat than the patient PAMA authority to value services as that instead of implementing the receiving PT services. The HCPAC and groups rather than individually— stratified code sets, CMS should the OT specialty society urged us to valuing each complexity level at 1.2 develop an alternative coding and consider the increase in work RVUs for work RVUs for the PT and OT family of payment model for therapy services and the OT evaluative services, indicating in evaluation codes for CY 2017. We recommended that we create a value- their comments that while the HCPAC believe this policy has advantages for based payment program, consistent with recommendations for the PT evaluations the Medicare program. It limits the the Triple Aim of health care, which were work-neutral, those for the OT incentives for and consequences of

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upcoding by therapists and providers, complexity levels using certain groups these commenters noted that some especially as therapists become more of diagnoses and patient types. The PT patients with multiple comorbidities familiar with the new set of codes. specialty society stated that because its and body structures involved are not Additionally, the policy assures work survey process included a broad cross- complicated, while others with few neutrality for these PT and OT code section of therapists working in the comorbidities and body structures families while allowing us to collect and various Medicare settings, it believed its involved are deceptively very complex, analyze utilization data of the utilization projections for the low, difficult to diagnose and treat. Another complexity levels for possible future moderate and high complexity commenter specifically recommended rulemaking. evaluation were representative. Many that each PT and OT evaluation We understand commenters’ concerns commenters told us because some complexity level should have the same about the possibility that the absence of therapists may not initially code the timeframes, as well as the same payment stratification in the complexity complexity levels correctly, that we component requirements. A few levels of the PT and OT evaluations would need to consider an entire year commenters voiced concern about how could have an effect on some therapists’ of utilization data to ensure its accuracy. CMS and our contractors will note these coding behavior in for these services in Response: We appreciate the views multiple required components of each CY 2017. However, we are also expressed and the information that the CPT code. One commenter noted that an concerned with the implication that commenters forwarded to us. However, evaluation may have characteristics that financial incentives are the primary we continue to have concerns that fall between two complexity levels and drivers for accurate coding for a therapists, particularly occupational told us that it should be up to the significant number of therapists, and if therapists, will not bill with the same clinician to determine which level is that is the case, we believe that utilization frequencies forecast by their most appropriate. A few commenters implementing stratified coding would specialty societies for the low, noted that the new detailed likely encourage upcoding since that is moderate, and high complexity requirements that dictate the level of consistent with the financial incentives. evaluations as described in the CY 2017 each code’s definition may cause We believe that the implementation of proposed rule. In other words, we are confusion for physical and occupational these new PT and OT code sets carries concerned with the possibility that we therapists, especially as they begin to with it an inherent change for the would establish rates (including for navigate the new codes. therapists furnishing the services since purposes of PFS budget neutrality) that Response: We appreciate the there will be three complexity levels to rely on the national organizations’ replace just one and each new code assessment of what ought to be billed, commenters’ concerns about new code contains newly defined necessary but Medicare spending and subsequent descriptors that detail the minimal components. We also believe that it is PFS budget neutrality assumptions will required components for each of the premature to predict how therapists will reflect actual billing given the financial eight new PT and OT evaluative code and bill the new complexity levels incentives inherent in stratified procedures. We realize that it may take before therapists gain familiarity with payment. Should we propose to value time to train therapists about the various the new codes. the evaluation codes individually in required components of each new PT Comment: We received several future rulemaking, we would seek and OT evaluative procedure code and comments on utilization assumptions additional objective data at that time. we have addressed this training in the inherent to the HCPAC We agree that an entire year of data is comment and response below. We also recommendations. Several commenters likely needed to appropriately analyze appreciate the commenters’ concern that questioned why we did not treat the the utilization of these evaluation the evaluative process is likely more HCPAC-recommended utilization services. We appreciate that our complex than the component parts assumptions for the PT and OT historical practice regarding significant comprising each code’s new coding complexity-stratified evaluation code revision of CPT coding scheme has requirements; however, as noted in the sets as we have historically treated other required us to make significant CY 2017 proposed rule, we proposed to codes sets that come to us from the assumptions regarding utilization for adopt the new CPT codes for PT and OT HCPAC or RUC; that is, using the new codes. We note that in many cases, evaluative procedures rather than utilization assumptions provided in the we have not accepted the assumptions propose a different coding structure recommendations. The HCPAC recommended by specialty societies and using G-codes. We would like to clarify explained that if the assumptions are the RUC and that we were not pricing for the commenters that were concerned overestimated, the HCPAC or RUC will groups of services together in the past. about ‘‘time requirements’’ in the new examine and determine whether to Comment: Several commenters PT and OT CPT code descriptors for recommend reductions. expressed concern about the new PT evaluative procedures that these We received several comments from and OT CPT code descriptors, ‘‘typical times’’ are included as a frame stakeholders in response to our specifically, that each descriptor of reference and do not represent a statement in the proposed rule that we includes minimal coding requirements. minimum coding requirement. Just as would request additional objective data Several commenters expressed the typical times included for each E/M to support the utilization crosswalks, skepticism that therapists will be able to code represent the physician face-to- especially for the OT codes, if we were report the new codes accurately—one of face time with the patient, the typical to value the codes individually for the these commenters believes the new times in the new PT and OT CPT codes PT and OT evaluation complexity codes rely on subjective clinical represent the typical face-to-face time of levels. In its comments, the OT specialty reasoning and decision making that will the physical or occupational therapist society explained that their frequency lead to further significant coding and with the patient. Regarding the estimations of the three complexity audit concerns for CMS. Several commenter’s concern about evaluations levels were based on the most recent commenters told us that they believe the that fall between two complexity levels, utilization frequency data from the 2014 true complexity of evaluating patients we would note general coding Medicare utilization from the five cannot be solely based on personal principles applicable to all codes—that percent sample file. The OT specialty factors, comorbidities, performance the therapist should select the society also stated that it defined the deficits, or time requirements. One of evaluation complexity level that best

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represents the furnished service and for evaluation services provided by thorough re-evaluation. The commenter which the medical necessity is clearly physical and occupational therapists recommended that both re-evaluations documented. and the associated documentation reflect the 30-minute typical time that is Comment: Many commenters requirements to ensure consistency and inherent to the OT re-evaluation code. requested that we delay documentation appropriate reporting of these services. Several commenters reminded us that requirements for the new PT and OT Several commenters asked us to the work RVU recommendations evaluative procedure codes; several consider a one-year reprieve from the forwarded to us were not considered commenters requested a one year payment consequences of medical work neutral because the HCPAC reprieve from application of medical review and audit requirements that accepted the PT and OT specialty review and audit requirements; and a address lack of documentation to societies’ beliefs as compelling evidence few commenters requested that we support the complexity level of the code that the practice of PT and OT have delay the implementation of the new billed. each significantly changed over the past CPT codes until CY 2018. Most of these Response: We understand that two decades. delay requests, commenters told us, implementing the new code sets for PT Some commenters reasoned that we were related to the time needed to and OT evaluative procedures will should accept the HCPAC- educate therapists about the new codes. require time for therapists to be recommended work RVUs for these Most of these commenters who asked us educated in their proper use. We would codes, in part, because the PT and OT not to implement new documentation like to remind those requesting we assist specialty societies completed the RUC– requirements also supported payment in writing guidelines that the CPT HCPAC defined survey process, stratification of the complexity levels for manual PM&R subsections for PT and including time and intensity of the the PT and OT evaluation complexity OT Evaluations contain official CPT services. levels. Concerned about the proposed guidelines. We understand the many Comments from the HCPAC, the PT lack of payment stratification, the PT requests for delay of new and OT specialty societies, and a few specialty society noted in its comments documentation requirements during the other stakeholders provided the that it asked CPT to postpone the codes initial year of their use. As such, for CY rationale that the practice of PT and OT for CPT 2017, but CPT denied the 2017, we will delay changes to our has significantly changed since 1997, request. In its comments, the PT society, current manual instructions for including the work of physical along with a few other stakeholders, documentation for evaluations and re- therapists and occupational therapists. also asked CMS to delay implementing evaluations in the Medicare Benefits Some of their rationale included: (a) the new CPT codes for CY 2017 ‘‘if there Policy Manual (MBPM), chapter 15, advances in technology has created is any way possible that does not section 220.3. opportunities for additional types of disrupt patient care.’’ We understand and appreciate that treatment approaches; and, (b) the work A few commenters say they will need the PT and OT specialty societies are RVUs for the PT and OT re-evaluation a delay of six months, at a minimum, to already underway in their educational codes have not kept pace with the train therapists, since all new efforts of therapists, as it has been our relativity of increases in work RVUs of descriptors include various required past experience with the comparable E/M codes that have elements and the typical time for each implementation of other CPT codes and historically been used as comparison: In PT and OT complexity level and the re- code sets that the leading educational 1997 the 0.60 work RVUs for CPT codes evaluation codes. The majority of role is assumed by the specialty 97002 and 97004 was 90 percent of that commenters, though, indicated they societies responsible for the code for CPT code 99213; today, it is just 62 would need a year for their educational changes. percent. Other rationales included ones efforts to be successful. In addition to Comment: We received many often cited by commenters requesting therapists, a few commenters told us comments objecting to our proposal to increases in RVUs, including increased they would have to educate coders and maintain a work RVU of 0.60 for the re- patient acuity and administrative and billers in the use of the new CPT codes. evaluation codes. Many commenters— reporting burdens. A few commenters noted the time to including therapy specialty societies Response: We appreciate the implement these new codes into their and organization representing therapy commenters’ remarks and the rationale billing systems was too short. providers and private practice physical forwarded in response to our request for The PT and OT specialty societies and occupational therapists, among comments. After a careful consideration each told us about their plans to educate other stakeholders—disagreed with our of the comments, we agree that their therapist members and proposal to maintain the work RVUs for modification of our proposal, to nonmembers to ensure coding accuracy. the PT and OT re-evaluation codes and recognize the change in practice since Each therapy association has already expressed their disappointment that we 1997 for the work of physical and begun this training, some of which will did not consider or accept the HCPAC occupational therapists, is appropriate. include webinars, self-paced online recommendations for increased work Because we believe that PT and OT have courses, frequently asked questions, RVUs of 0.75 for PT (CPT code 97164) similar work, though, we are finalizing documentation resources, published and 0.8 for OT (CPT code 97168). the value of both codes at the same work articles, etc. One commenter supported increasing RVUs by assigning a work RVU of Some commenters asked CMS to work the work RVUs, but suggested that the 0.75—the HCPAC-recommended work with various stakeholders and to either PT and OT re-evaluation codes should RVU for the PT re-evaluation and the PT establish guidelines or assist in be equally valued for the relative work, low complexity evaluation. educating therapists about the new PE and MP RVUs. This same commenter We would like to take this codes through Open Door Forums, MLN contended that because the patients opportunity to remind physical and articles, etc. Additionally, they also treated by the PT and OT disciplines for occupational therapists about our wanted to work with CMS on LCDs hand rehabilitation are the same; that is, manual instructions regarding the established by contractors. One have the same functional and cognitive reporting of a both the evaluation and commenter stated that CMS must deficits, the same time and expertise of re-evaluation codes (MBPM, Chapter 15, provide clear guidance regarding the both physical and occupational section 220). Of note, to be separately selection of the appropriate level of therapists is required to perform a payable, the re-evaluation requires a

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significant change in the patient’s MBPM full definitions follow in Table condition or functional status that was 22. not anticipated in the plan of care. The

TABLE 22—FULL DEFINITIONS FOR MBPM

Therapy service Definition

EVALUATION ...... EVALUATION is a separately payable comprehensive service provided by a clinician, as defined above, that requires professional skills to make clinical judgments about conditions for which services are indicated based on objective measurements and subjective evaluations of patient performance and functional abilities. Evaluation is warranted for example, for a new diagnosis or when a condition is treated in a new setting. These evaluative judgments are essential to development of the plan of care, including goals and the selection of interventions. RE-EVALUATION ...... RE–EVALUATION provides additional objective information not included in other documentation. Re-evaluation is separately payable and is periodically indicated during an episode of care when the professional assessment of a clinician indicates a significant improvement, or decline, or change in the patient’s condition or functional status that was not anticipated in the plan of care. Although some state regulations and state practice acts require re-evaluation at specific times, for Medicare payment, re-evaluations must also meet Medicare coverage guidelines.

Comment: We received a few final PE RVUs of the PT and OT we are finalizing the PE inputs as comments regarding our PE proposals in evaluation and re-evaluation codes. proposed. the CY 2017 proposed rule for the PT After considering the comments, in iv. Always Therapy Codes and OT evaluation and re-evaluation summary, we are finalizing our codes. In its comments, the PT specialty proposals to (a) accept the new CPT It is important to note that CMS society, in response to our PE proposal, codes 97161–97168 for PT and OT defines the codes for these evaluative explained, per our request, the use of services as ‘‘always therapy.’’ This the 4 sheets of paper as supply items in evaluative procedures and (b) use the means that they always represent the PT evaluation and re-evaluation PAMA smoothing authority to value the codes. The OT specialty society noted PT and OT complexity level evaluations therapy services regardless of who that they accepted the PE refinements as groups of services rather than performs them and always require a we proposed in the proposed rule. individually by assigning a work RVU of therapy modifier, GP or GO, to signify Response: We appreciate the 1.2 to each complexity level. We are that the services are furnished under a comments from both the PT and OT modifying our proposal for the PT or OT plan of care, respectively. specialty societies. We will finalize the valuation of the PT and OT re- These codes will also be subject to the PE input changes as proposed and evaluation codes and are finalizing a therapy MPPR and to statutory therapy include them in the calculation of the work RVU of 0.75 for each code. Lastly, caps.

TABLE 23—CPT LONG DESCRIPTORS FOR PHYSICAL MEDICINE AND REHABILITATION

New CPT code CPT long descriptors for physical medicine and rehabilitation

97161 ...... Physical therapy evaluation: low complexity, requiring these components: • A history with no personal factors and/or comorbidities that impact the plan of care; • An examination of body system(s) using standardized tests and measures addressing 1–2 elements from any of the following: body structures and functions, activity limitations, and/or participation restrictions; • A clinical presentation with stable and/or uncomplicated characteristics; and • Clinical decision making of low complexity using standardized patient assessment instrument and/or measurable assessment of functional outcome. Typically, 20 minutes are spent face-to-face with the patient and/or family. 97162 ...... Physical therapy evaluation: moderate complexity, requiring these components: • A history of present problem with 1–2 personal factors and/or comorbidities that impact the plan of care; • An examination of body systems using standardized tests and measures in addressing a total of 3 or more elements from any of the following body structures and functions, activity limitations, and/or participation restrictions; • An evolving clinical presentation with changing characteristics; and • Clinical decision making of moderate complexity using standardized patient assessment instrument and/or measurable assessment of functional outcome. Typically, 30 minutes are spent face-to-face with the patient and/or family. 97163 ...... Physical therapy evaluation: high complexity, requiring these components: • A history of present problem with 3 or more personal factors and/or comorbidities that impact the plan of care; • An examination of body systems using standardized tests and measures addressing a total of 4 or more elements from any of the following: body structures and functions, activity limitations, and/or participation restrictions; • A clinical presentation with unstable and unpredictable characteristics; and • Clinical decision making of high complexity using standardized patient assessment instrument and/or measurable assessment of functional outcome. Typically, 45 minutes are spent face-to-face with the patient and/or family.

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TABLE 23—CPT LONG DESCRIPTORS FOR PHYSICAL MEDICINE AND REHABILITATION—Continued

New CPT code CPT long descriptors for physical medicine and rehabilitation

97164 ...... Re-evaluation of physical therapy established plan of care, requiring these components: • An examination including a review of history and use of standardized tests and measures is required; and • Revised plan of care using a standardized patient assessment instrument and/or measurable assessment of functional outcome. Typically, 20 minutes are spent face-to-face with the patient and/or family. 97165 ...... Occupational therapy evaluation, low complexity, requiring these components: • An occupational profile and medical and therapy history, which includes a brief history including review of medical and/or therapy records relating to the presenting problem; • An assessment(s) that identifies 1–3 performance deficits (i.e., relating to physical, cognitive, or psychosocial skills) that result in activity limitations and/or participation restrictions; and • Clinical decision making of low complexity, which includes an analysis of the occupational profile, analysis of data from problem-focused assessment(s), and consideration of a limited number of treatment options. Patient presents with no comorbidities that affect occupational performance. Modification of tasks or assistance (eg, physical or verbal) with assessment(s) is not necessary to enable completion of evaluation component. Typically, 30 minutes are spent face-to-face with the patient and/or family. 97166 ...... Occupational therapy evaluation, moderate complexity, requiring these components: • An occupational profile and medical and therapy history, which includes an expanded review of medical and/or therapy records and additional review of physical, cognitive, or psychosocial history related to current functional performance; • An assessment(s) that identifies 3–5 performance deficits (i.e., relating to physical, cognitive, or psychosocial skills) that result in activity limitations and/or participation restrictions; and • Clinical decision making of moderate analytic complexity, which includes an analysis of the occupational profile, analysis of data from detailed assessment(s), and consideration of several treatment options. Patient may present with comorbidities that affect occupational performance. Minimal to moderate modification of tasks or assistance (eg, physical or verbal) with assessment(s) is necessary to enable patient to complete evaluation component. Typically, 45 minutes are spent face-to-face with the patient and/or family. 97167 ...... Occupational therapy evaluation, high complexity, requiring these components: • An occupational profile and medical and therapy history, which includes review of medical and/or therapy records and extensive additional review of physical, cognitive, or psychosocial history related to current functional performance; • An assessment(s) that identify 5 or more performance deficits (i.e., relating to physical, cognitive, or psychosocial skills) that result in activity limitations and/or participation restrictions; and • A clinical decision-making is of high analytic complexity, which includes an analysis of the patient profile, analysis of data from comprehensive assessment(s), and consideration of multiple treatment options. Patient presents with comorbidities that affect occupational performance. Significant modification of tasks or assistance (eg, physical or verbal) with assessment(s) is necessary to enable patient to complete evaluation component. Typically, 60 minutes are spent face-to-face with the patient and/or family. 97168 ...... Re-evaluation of occupational therapy established plan of care, requiring these components: • An assessment of changes in patient functional or medical status with revised plan of care; • An update to the initial occupational profile to reflect changes in condition or environment that affect future interventions and/or goals; and • A revised plan of care. A formal reevaluation is performed when there is a documented change in functional status or a significant change to the plan of care is required. Typically, 30 minutes are spent face-to-face with the patient and/or family.

v. Potentially Misvalued Therapy Codes section 1848(c)(2)(K)(ii)(VII) of the Act. regarding appropriate valuation for the We understand that the therapy existing codes. See Table 24. Since 2010, in addition to the codes specialty organizations have pursued for evaluative services, CMS has Comment: We received multiple the development of coding changes comments on our nomination of the ten periodically added codes that represent through the CPT process for these therapy services to the list of potentially therapy codes to the potentially modality and procedure services. While misvalued codes. The current list of ten misvalued code list. The PT and OT we understand that, in some cases, it therapy codes was based on the specialty societies each expressed may take several years to develop statutory category ‘‘codes that account concern that we issued the potentially appropriate coding revisions, we are, in for the majority of spending under the misvalued code list knowing that they physician fee schedule,’’ as specified in the meantime, seeking information are currently working with the AMA

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Relativity Assessment Workgroup cautioned that any review must also (57) Valuation of Services Where (RAW) to survey and submit CPT consider that all of these codes are Moderate Sedation is an Inherent Part of changes to certain intervention codes in already subject to a 50 percent MPPR the Procedure and Valuation of the PM&R family, including some codes reduction. One commenter believes the Moderate Sedation Services (CPT Codes on the misvalued code list. Nonetheless, work of CPT code 97140 is undervalued 99151, 99152, 99153, 99155, 99156, and the PT specialty society told us that it compared to other codes since it 99157; and HCPCS Code G0500) will work with the RUC (as the requires the more skilled therapist using appropriate venue) this fall to survey manual techniques to touch the patient. In the CY 2015 PFS proposed rule (79 and value the codes; but asked to meet Response: We will include a valuation FR 40349), we noted that it appeared with us in early 2017 to discuss their discussion during CY 2018 rulemaking that practice patterns for endoscopic progress. The OT specialty society of those codes for which we receive procedures were changing. Anesthesia stated that it has already begun work RUC recommendations by/at its services are increasingly being with AMA to expedite valuation surveys February 2017 meeting. separately reported for endoscopic for relevant codes, but also noted its procedures, meaning that resource costs intent to resume work with the RAW to TABLE 24—POTENTIALLY MISVALUED associated with sedation were no longer replace some of the codes on the CODES IDENTIFIED THROUGH HIGH incurred by the practitioner reporting misvalued code list, including CPT code the procedure. Subsequently, in the CY 97535, as soon as the misvalued code EXPENDITURE BY SPECIALTY 2016 PFS proposed rule (80 FR 41707), survey process is complete. In addition, SCREEN we solicited public comment and the OT specialty society noted its belief HCPCS recommendations on approaches to that CMS staff attendance at the RAW code Short descriptor condoned their timeline for proceeding address the appropriate valuation of moderate sedation related to the with various PM&R code revisions. 97032 ...... Electrical stimulation. A few commenters believe the codes 97035 ...... Ultrasound therapy. approximately 400 diagnostic and on the potentially misvalued code list 97110 ...... Therapeutic exercises. therapeutic procedures for which the are already valued correctly as the PE 97112 ...... Neuromuscular reeducation. CPT Editorial Panel has determined that inputs for many therapy codes, 97113 ...... Aquatic therapy/exercises. moderate sedation is an inherent part of including those defined by 15-minute 97116 ...... Gait training therapy. furnishing the service. The CPT intervals, have already been adjusted by 97140 ...... Manual therapy 1/regions. Editorial Panel created separate codes the PEAC/RUC/HCPAC to account for 97530 ...... Therapeutic activities. 97535 ...... Self care mngment training. for reporting moderate sedation services efficiencies when billed with other G0283 ...... Elec stim other than wound. (see Table 25). therapy codes. Several commenters

TABLE 25—MODERATE SEDATION CODES AND DESCRIPTORS

CPT/HCPCS code Descriptor

99151 ...... Moderate sedation services provided by the same physician or other qualified health care professional performing the diagnostic or therapeutic service that the sedation supports, requiring the presence of an independent trained observer to assist in the monitoring of the patient’s level of consciousness and physiological status; initial 15 minutes of intra-service time, patient younger than 5 years of age. 99152 ...... Moderate sedation services provided by the same physician or other qualified health care professional performing the diagnostic or therapeutic service that the sedation supports, requiring the presence of an independent trained observer to assist in the monitoring of the patient’s level of consciousness and physiological status; initial 15 minutes of intra-service time, patient age 5 years or older. 99153 ...... Moderate sedation services provided by the same physician or other qualified health care professional performing the diagnostic or therapeutic service that the sedation supports, requiring the presence of an independent trained observer to assist in the monitoring of the patient’s level of consciousness and physiological status; each additional 15 minutes of intra-service time (List separately in addition to code for primary service). 99155 ...... Moderate sedation services provided by a physician or other qualified health care professional other than the physician or other qualified health care professional performing the diagnostic or therapeutic service that the sedation supports; initial 15 minutes of intra-service time, patient younger than 5 years of age. 99156 ...... Moderate sedation services provided by a physician or other qualified health care professional other than the physician or other qualified health care professional performing the diagnostic or therapeutic service that the sedation supports; initial 15 minutes of intra-service time, patient age 5 years or older. 99157 ...... Moderate sedation services provided by a physician or other qualified health care professional other than the physician or other qualified health care professional performing the diagnostic or therapeutic service that the sedation supports; each additional 15 minutes intra-service time (List separately in addition to code for primary service).

For the newly created moderate codes 99155 and 99156 making a similar the RUC-recommended direct PE inputs sedation CPT codes, we proposed to use distinction. The RUC recommendations for all six codes. the RUC-recommended work RVUs for included a work RVU increment of 0.25 We stated in the CY 2017 proposed CPT codes 99151, 99152, 99155, and between CPT codes 99151 and 99152. rule that when moderate sedation is 99157. We stated in the CY 2017 For CPT code 99156, we proposed a reported for Medicare beneficiaries, we proposed rule that CPT codes 99151 and work RVU of 1.65 to maintain the 0.25 expect that it would most frequently be 99152 make a distinction between increment relative to CPT code 99155 (a reported using the code that describes moderate sedation services furnished to RUC-recommended work RVU of 1.90) moderate sedation furnished by the patients younger than 5 years of age and and maintain relativity among the CPT same person who also performs the patients 5 years or older, with CPT codes in this family. We proposed to use primary procedure for patients 5 years

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of age or older. Under the new coding report moderate sedation, we stated in disagreed with our proposed structure, these moderate sedation the proposed rule that the RUC refinements for one of the new moderate services would be reported using CPT provided recommendations that valued sedation CPT codes. While most code 99152, for which we proposed a the procedural services without commenters were supportive of CMS’ work RVU of 0.25, consistent with the moderate sedation. However, the RUC proposal to use a methodology to RUC recommendations for this code. recommended removing fewer RVUs revalue the procedural services without Stakeholders presented information that from the procedures than it moderate sedation, some commenters illustrated that the specialty group recommended for valuing the moderate suggested that we should revalue certain survey data regarding the work involved sedation services that were removed procedures differently (for example, in furnishing moderate sedation from the procedure codes. In other apply a lower work RVU reduction or described by CPT code 99152 showed a words, the RUC recommended that make no reduction). A few commenters significant bimodal distribution overall payments for these procedures were opposed to separate reporting of between procedural services furnished should be increased now that moderate sedation and suggested by gastroenterologists (GI) and those practitioners would be required to alternatives for CMS to consider. Our services furnished by other specialties. report the sedation services that were responses to commenters’ specific The GI societies’ survey data reported a previously included as inherent parts of issues are included below. median valuation of 0.10 work RVUs for the procedures. We stated in the Comment: Many commenters moderate sedation furnished by the proposed rule that we believe that if we expressed support for CMS’ proposal to same person furnishing the base were to use the RUC recommendations accept the RUC’s recommendations for procedure. Given the significant volume for revaluation of the procedural new moderate sedation CPT codes of moderate sedation furnished by GI services without refinement, the RVUs 99151, 99152, 99153, 99155, and 99157. practitioners and the significant currently attributable to the redundant Several commenters, including the RUC difference in RVUs reported in the payment for sedation services when and medical specialty societies, survey data, we proposed to make anesthesia is separately reported would disagreed with CMS’ proposal to value payment using a GI endoscopy-specific be used exclusively to increase overall CPT code 99156 at 1.65 work RVUs. moderate sedation code (HCPCS code payment for these services. We refer Commenters requested that CMS G0500) that would be used in lieu of the readers to section II.D.5. of this final finalize the RUC-recommended work new CPT moderate sedation coding for rule, which includes a more extensive RVU of 1.84 (the 25th percentile survey use with other services. discussion of our general principle that result). Commenters stated that there • G0500: moderate sedation services overall resource costs for procedures were clinical differences in the typical provided by the same physician or other that include moderate sedation do not patients that receive services that would qualified health care professional inherently change based solely on be reported using CPT code 99156, performing a gastrointestinal changes in coding. disagreeing with CMS’ proposal to endoscopic service (excluding biliary To account for the separate billing of reduce the work RVU for CPT code procedures) that sedation supports, moderate sedation services, we 99156 to maintain relativity among the requiring the presence of an proposed to maintain current values for code pairs in this family. Commenters independent trained observer to assist the procedure codes less the work RVUs suggested that CPT code 99156 would in the monitoring of the patient’s level associated with the most frequently be used to report moderate sedation of consciousness and physiological reported corresponding moderate services that are currently reported status; initial 15 minutes of intra-service sedation code so that practitioners using CPT code 99149. Commenters time; patient age 5 years or older. furnishing the moderate sedation stated that CPT code 99149 was We proposed to value HCPCS code services previously considered to be typically performed in the emergency G0500 at 0.10 work RVUs based on the inherent in the procedure would have department (approximately 58 percent median survey result for GI respondents no change in overall work RVUs. Since of the time), indicating that the typical in the survey data. We proposed that we proposed 0.10 work RVUs for patient is either acutely ill or injured, when moderate sedation services are moderate sedation for the GI endoscopy and that moderate sedation services are furnished by the same practitioner procedures, we proposed a typically performed without support reporting the GI endoscopy procedure, corresponding 0.10 reduction in work staff, which commenters suggested practitioners would report the sedation RVUs for these same procedures. For all further justified a work RVU of 1.84 for services using HCPCS code G0500 other Appendix G procedures that CPT code 99156. instead of CPT code 99152. In all other currently include moderate sedation as Response: The code descriptors for cases, we proposed that practitioners an inherent part of the procedure, we each of the new moderate sedation CPT would report moderate sedation using proposed to remove 0.25 work RVUs codes make distinctions between the one of the new moderate sedation CPT from the current values. ages of the patients and the clinical staff codes consistent with CPT guidance. We received 22 comments from involved in furnishing the moderate This would include the full range of medical professionals, ambulatory sedation services. The typical patient codes for those furnishing moderate surgical centers (ASCs), manufacturers, vignettes used in the specialty societies’ sedation with the remaining (non-GI and professional medical specialty surveys did not indicate clinical endoscopy) base procedures, as well as societies representing radiation differences between patients receiving for the other circumstances during oncology, brachytherapy, colon and moderate sedation services reported which moderate sedation is furnished rectal surgeons, certified registered using CPT code 99156 compared to along with a GI endoscopy (for example, nurse anesthetists (CRNAs), pediatrics, services reported with CPT code 99155. to a patient under 5 years of age or for cardiology, thorasic surgery, general Additionally, the typical patient a biliary procedure, the endoscopist surgery, gastroenterology, emergency vignettes for CPT codes 99151 and furnishing moderate sedation should medicine, interventional radiology, and 99152 did not indicate clinical not use HCPCS code G0500, but instead vascular surgery. Commenters were differences in the patients. We continue use the appropriate CPT code. generally supportive of CMS’ proposals to believe that the work RVU increment In addition to proposing work RVUs related to valuation of the new moderate of 0.25 should be maintained between for the new codes used to separately sedation codes. A few commenters CPT codes 99155 and 99156 since these

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codes have the same younger than age the proceduralists, as previously Appendix G was established, or the 5/older than age 5 dynamic as described assumed. Therefore, we believe that a work of moderate sedation was not by CPT codes 99151 and 99152. different amount of work RVUs should included in the valuation of certain Therefore, for CY 2017, we are be removed from the Appendix G procedures. finalizing work RVUs for the moderate services only in cases where the typical Response: We appreciate the sedation codes as follows: moderate sedation code also has a commenters’ feedback regarding our • Work RVU of 0.50 for CPT code different amount of assigned work proposals. We remind stakeholders that 99151; RVUs, such as the case with codes that the potentially misvalued code process • Work RVU of 0.25 for CPT code would be reported with G0500. In other is intended to improve the accuracy of 99152; words, we believe that there should be the RVUs assigned to particular codes. • Work RVU of 1.90 for CPT code a direct relationship, for each code, We welcome feedback from interested 99155; individuals, stakeholders, and specialty • between the work RVUs attributable to Work RVU of 1.65 for CPT code moderate sedation, regardless of societies regarding the valuation of 99156; and • whether it is automatically included in specific codes for consideration in Work RVU of 1.25 for CPT code payment for a given procedure (at future rulemaking. 99157. current) or separately reported (as Comment: A few commenters stated We note that CPT code 99153 is a PE- proposed). that CMS did not provide a rationale to only code and we are finalizing the Comment: A few commenters support that moderate sedation proposed PE inputs for CPT code 99153, expressed concerns that the proposed furnished with GI endoscopy services as well as finalizing the proposed PE revaluation methodology would disturb required less work than moderate inputs for all other codes in this family the relativity of many of the Appendix sedation furnished with other Appendix without modification. G codes, along with the increasing G procedures. Comment: While many commenters administrative burden by requiring Response: Our proposal was based on supported use of a methodological separate reporting of the procedural and the GI societies’ survey data included in approach to revaluing Appendix G moderate sedation services. Other the RUC recommendations that reported procedural services, some commenters commenters suggested that CMS a median valuation of 0.10 work RVUs disagreed with CMS’ proposed consider alternatives including only for moderate sedation furnished by the refinements to the RUC’s recommended addressing revaluation of Appendix G same person furnishing the base methodology. Commenters suggested services where moderate sedation is no procedure. that the RUC’s approach was consistent longer inherent or only those procedural Comment: A few commenters with how the services were originally services reported with separate suggested that creation of HCPCS code valued and was budget neutral within anesthesia services the majority of the G0500 would cause confusion among these services. The RUC, along with time. practitioners since the new CPT codes several commenters representing Response: We appreciate the concerns developed to report moderate sedation specialty medical societies, requested of commenters regarding both the issues do not differentiate between GI and non- that CMS use the same RUC-approved of relativity within families of codes, as GI procedures. One commenter stated two-tier methodology for removing work well as concerns regarding that HCPCS code G0500 is time based, RVUs associated with the work of administrative burden. However, we and therefore, to report the code, at least moderate sedation from Appendix G believe that it serves relativity to 50 percent of the time (7.5 minutes) is services based on whether the code was maintain the overall work RVUs for required, but the GI subset of data that assigned to one of two preservice time each of the services when reported with CMS accepted to create the HCPCS code packages used by the RUC in developing moderate sedation, which would be G0500 indicates an intraservice time of recommendations. Using the same two- typical for many of these codes. While 5 minutes. The commenter went on to tier methodology, the RUC suggested we understand the value in reducing the state that it would appear that a majority removal of 0.10 work RVUs for some GI number of codes required to be reported of the GI endoscopists would never be services and 0.19 work RVUs from other for payment under the PFS, we also able to report HCPCS code G0500. GI services, depending on the RUC’s believe that it is important that the Response: We expect that assignment of pre-service time. coding be granular enough to allow us practitioners will report the appropriate Response: We understand that some to identify which services are furnished CPT or HCPCS code that most stakeholders would prefer that we use to Medicare beneficiaries by which accurately describes the services the RUC’s recommendations so that the practitioners. It is also clear to us that performed during a patient encounter, RVUs currently attributable to the the accuracy of the assumption of including those services performed redundant payment for sedation moderate sedation as inherent for concurrently and in support of a services when anesthesia is separately particular procedures may change over procedural service consistent with CPT reported would be used exclusively to time, as we have seen reflected in the guidance. We note that the commenter increase overall payment for these claims data. We do not believe that a refers to the time for moderate sedation services. We also understand that the shifting set of services where moderate in the survey data, while the time RUC assumes that the amount of pre- sedation values are alternatively thresholds for the moderate sedation service time for particular services may included or not included in the codes are intended to match the reflect a different level of preparation valuation of particular codes based on intraservice time of the procedure itself. required for sedation services. However, annual analysis of claims data would be We reviewed the intraservice time we continue to believe that the overall likely to be administratively easier for assumptions for the procedure codes, resource costs for the procedures practitioners. and only one includes an intraservice including moderate sedation do not Comment: A few commenters time as low as 7.5 minutes and none inherently change based solely on requested that CMS not finalize its lower. Table 26 identifies the GI changes in coding, so we do not believe proposal to reduce the work RVUs for endoscopic services for which HCPCS that our assignment of overall work certain procedures. Some commenters code G0500 will be used to report RVUs should increase in cases where indicated that certain codes identified moderate sedation services (available in the moderate sedation is performed by in Appendix G were valued before the ‘‘downloads’’ section of the PFS

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Web site at http://www.cms.gov/ We are also modifying the code proposed modifications to maintain the Medicare/Medicare-Feefor-Service- descriptor for HCPCS code G0500 to current values for the procedure codes Payment/PhysicianFeeSched/PFS- reflect these changes. Therefore, we are less the work RVUs associated with the Federal-Regulation-Notices.html). finalizing the descriptor for HCPCS code most frequently reported corresponding Comment: Several commenters G0500 as: moderate sedation code. Practitioners disagreed with CMS’ proposal to revalue • G0500: Moderate sedation services furnishing the moderate sedation Appendix G esophageal dilation, biliary provided by the same physician or other services previously considered to be endoscopy, and ERCP procedures minus qualified health care professional inherent in the procedure will have no 0.25 work RVUs instead of minus 0.10 performing a gastrointestinal change in overall work RVUs. Since we work RVUs, similar to other endoscopy endoscopic service that sedation are finalizing a work RVU of 0.10 services identified in Appendix G. supports, requiring the presence of an (HCPCS code G0500) for moderate Commenters requested that CMS only independent trained observer to assist sedation for the GI endoscopy reduce these procedural services with a in the monitoring of the patient’s level procedures, we are finalizing a 0.10 work RVU reduction, and allow of consciousness and physiological corresponding 0.10 reduction in work reporting of moderate sedation using status; initial 15 minutes of intra-service RVUs for the corresponding procedural HCPCS code G0500, similar to other time; patient age 5 years or older. services. For all other Appendix G endoscopy procedures identified in (additional time may be reported with procedures that currently include Appendix G. 99153, as appropriate). moderate sedation as an inherent part of Response: While we continue to Comment: Some commenters the procedure, we are finalizing a 0.25 believe that the moderate sedation work requested that CMS provide work RVU reduction from the current for Appendix G esophageal dilation, practitioners and providers with values. biliary endoscopy, and ERCP instructions on use of the newly created procedures is more extensive than for moderate sedation codes, allow for Table 26 lists the CY 2016 work RVUs other endoscopy procedures identified additional time to implement the coding for each applicable service and our in Appendix G, for CY 2017, after changes, and provide MACs appropriate proposed and final CY 2017 refined considering the comments, we are claims processing instructions specific work RVUs using the finalized finalizing a revaluation of certain to these codes. revaluation methodology described esophageal dilation, biliary endoscopy, Response: We plan to issue above. Additionally, the table identifies and ERCP procedures minus 0.10 work appropriate claims processing the GI endoscopic services for which RVUs instead of the 0.25 work RVU instructions to the local MACs. We do HCPCS code G0500 will be used to reduction as proposed (see Table 26 for not believe that an implementation report moderate sedation services additional information). We will delay is necessary since the new CPT (available in the ‘‘downloads’’ section of continue to monitor claims data related and HCPCS codes will be effective the PFS Web site at http:// to separately billed anesthesia services January 1, 2017 and available for use by www.cms.gov/Medicare/Medicare- performed in conjunction with these practitioners and providers at that time. Feefor-Service-Payment/ procedures to inform future rulemaking In summary, after consideration of the PhysicianFeeSched/PFS-Federal- related to the valuation of these codes. comments, we are finalizing our Regulation-Notices.html).

TABLE 26—VALUATIONS FOR SERVICES MINUS MODERATE SEDATION

Use HCPCS code G0500 CY 2016 CY 2017 CY 2017 to report CPT code work RVU proposed final work moderate work RVU RVU sedation (Y/N)

10030 ...... 3.00 2.75 2.75 N 19298 ...... 6.00 5.75 5.75 N 20982 ...... 7.27 7.02 7.02 N 20983 ...... 7.13 6.88 6.88 N 22510 ...... 8.15 7.90 7.90 N 22511 ...... 7.58 7.33 7.33 N 22512 ...... 4.00 4.00 4.00 N 22513 ...... 8.90 8.65 8.65 N 22514 ...... 8.24 7.99 7.99 N 22515 ...... 4.00 4.00 4.00 N 22526 ...... 6.10 5.85 5.85 N 22527 ...... 3.03 3.03 3.03 N 31615 ...... 2.09 1.84 1.84 N 31622 ...... 2.78 2.53 2.53 N 31623 ...... 2.88 2.63 2.63 N 31624 ...... 2.88 2.63 2.63 N 31625 ...... 3.36 3.11 3.11 N 31626 ...... 4.16 3.91 3.91 N 31627 ...... 2.00 2.00 2.00 N 31628 ...... 3.80 3.55 3.55 N 31629 ...... 4.00 3.75 3.75 N 31632 ...... 1.03 1.03 1.03 N 31633 ...... 1.32 1.32 1.32 N 31634 ...... 4.00 3.75 3.75 N 31635 ...... 3.67 3.42 3.42 N 31645 ...... 3.16 2.91 2.91 N

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TABLE 26—VALUATIONS FOR SERVICES MINUS MODERATE SEDATION—Continued

Use HCPCS code G0500 CY 2016 CY 2017 CY 2017 to report CPT code work RVU proposed final work moderate work RVU RVU sedation (Y/N)

31646 ...... 2.72 2.47 2.47 N 31647 ...... 4.40 4.15 4.15 N 31648 ...... 4.20 3.95 3.95 N 31649 ...... 1.44 1.44 1.44 N 31651 ...... 1.58 1.58 1.58 N 31652 ...... 4.71 4.46 4.46 N 31653 ...... 5.21 4.96 4.96 N 31654 ...... 1.40 1.40 1.40 N 31660 ...... 4.25 4.00 4.00 N 31661 ...... 4.50 4.25 4.25 N 31725 ...... 1.96 1.71 1.71 N 32405 ...... 1.93 1.68 1.68 N 32550 ...... 4.17 3.92 3.92 N 32551 ...... 3.29 3.04 3.04 N 32553 ...... 3.80 3.55 3.55 N 33010 ...... 2.24 1.99 1.99 N 33011 ...... 2.24 1.99 1.99 N 33206 ...... 7.39 7.14 7.14 N 33207 ...... 8.05 7.80 7.80 N 33208 ...... 8.77 8.52 8.52 N 33210 ...... 3.30 3.05 3.05 N 33211 ...... 3.39 3.14 3.14 N 33212 ...... 5.26 5.01 5.01 N 33213 ...... 5.53 5.28 5.28 N 33214 ...... 7.84 7.59 7.59 N 33216 ...... 5.87 5.62 5.62 N 33217 ...... 5.84 5.59 5.59 N 33218 ...... 6.07 5.82 5.82 N 33220 ...... 6.15 5.90 5.90 N 33221 ...... 5.80 5.55 5.55 N 33222 ...... 5.10 4.85 4.85 N 33223 ...... 6.55 6.30 6.30 N 33227 ...... 5.50 5.25 5.25 N 33228 ...... 5.77 5.52 5.52 N 33229 ...... 6.04 5.79 5.79 N 33230 ...... 6.32 6.07 6.07 N 33231 ...... 6.59 6.34 6.34 N 33233 ...... 3.39 3.14 3.14 N 33234 ...... 7.91 7.66 7.66 N 33235 ...... 10.15 9.90 9.90 N 33240 ...... 6.05 5.80 5.80 N 33241 ...... 3.29 3.04 3.04 N 33244 ...... 13.99 13.74 13.74 N 33249 ...... 15.17 14.92 14.92 N 33262 ...... 6.06 5.81 5.81 N 33263 ...... 6.33 6.08 6.08 N 33264 ...... 6.60 6.35 6.35 N 33282 ...... 3.50 3.25 3.25 N 33284 ...... 3.00 2.75 2.75 N 33990 ...... 8.15 7.90 7.90 N 33991 ...... 11.88 11.63 11.63 N 33992 ...... 4.00 3.75 3.75 N 33993 ...... 3.51 3.26 3.26 N 35471 ...... 10.05 9.80 9.80 N 35472 ...... 6.90 6.65 6.65 N 35475 ...... 6.60 6.35 6.35 N 35476 ...... 5.10 4.85 4.85 N 36010 ...... 2.43 2.18 2.18 N 36140 ...... 2.01 1.76 1.76 N 36147 ...... 3.72 3.47 3.47 N 36148 ...... 1.00 1.00 1.00 N 36200 ...... 3.02 2.77 2.77 N 36221 ...... 4.17 3.92 3.92 N 36222 ...... 5.53 5.28 5.28 N 36223 ...... 6.00 5.75 5.75 N 36224 ...... 6.50 6.25 6.25 N 36225 ...... 6.00 5.75 5.75 N 36226 ...... 6.50 6.25 6.25 N

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TABLE 26—VALUATIONS FOR SERVICES MINUS MODERATE SEDATION—Continued

Use HCPCS code G0500 CY 2016 CY 2017 CY 2017 to report CPT code work RVU proposed final work moderate work RVU RVU sedation (Y/N)

36227 ...... 2.09 2.09 2.09 N 36228 ...... 4.25 4.25 4.25 N 36245 ...... 4.90 4.65 4.65 N 36246 ...... 5.27 5.02 5.02 N 36247 ...... 6.29 6.04 6.04 N 36248 ...... 1.01 1.01 1.01 N 36251 ...... 5.35 5.10 5.10 N 36252 ...... 6.99 6.74 6.74 N 36253 ...... 7.55 7.30 7.30 N 36254 ...... 8.15 7.90 7.90 N 36481 ...... 6.98 6.73 6.73 N 36555 ...... 2.68 2.43 2.43 N 36557 ...... 5.14 4.89 4.89 N 36558 ...... 4.84 4.59 4.59 N 36560 ...... 6.29 6.04 6.04 N 36561 ...... 6.04 5.79 5.79 N 36563 ...... 6.24 5.99 5.99 N 36565 ...... 6.04 5.79 5.79 N 36566 ...... 6.54 6.29 6.29 N 36568 ...... 1.92 1.67 1.67 N 36570 ...... 5.36 5.11 5.11 N 36571 ...... 5.34 5.09 5.09 N 36576 ...... 3.24 2.99 2.99 N 36578 ...... 3.54 3.29 3.29 N 36581 ...... 3.48 3.23 3.23 N 36582 ...... 5.24 4.99 4.99 N 36583 ...... 5.29 5.04 5.04 N 36585 ...... 4.84 4.59 4.59 N 36590 ...... 3.35 3.10 3.10 N 36870 ...... 5.20 4.95 4.95 N 37183 ...... 7.99 7.74 7.74 N 37184 ...... 8.66 8.41 8.41 N 37185 ...... 3.28 3.28 3.28 N 37186 ...... 4.92 4.92 4.92 N 37187 ...... 8.03 7.78 7.78 N 37188 ...... 5.71 5.46 5.46 N 37191 ...... 4.71 4.46 4.46 N 37192 ...... 7.35 7.10 7.10 N 37193 ...... 7.35 7.10 7.10 N 37197 ...... 6.29 6.04 6.04 N 37211 ...... 8.00 7.75 7.75 N 37212 ...... 7.06 6.81 6.81 N 37213 ...... 5.00 4.75 4.75 N 37214 ...... 2.74 2.49 2.49 N 37215 ...... 18.00 17.75 17.75 N 37216 ...... 0.00 0.00 0.00 N 37218 ...... 15.00 14.75 14.75 N 37220 ...... 8.15 7.90 7.90 N 37221 ...... 10.00 9.75 9.75 N 37222 ...... 3.73 3.73 3.73 N 37223 ...... 4.25 4.25 4.25 N 37224 ...... 9.00 8.75 8.75 N 37225 ...... 12.00 11.75 11.75 N 37226 ...... 10.49 10.24 10.24 N 37227 ...... 14.50 14.25 14.25 N 37228 ...... 11.00 10.75 10.75 N 37229 ...... 14.05 13.80 13.80 N 37230 ...... 13.80 13.55 13.55 N 37231 ...... 15.00 14.75 14.75 N 37232 ...... 4.00 4.00 4.00 N 37233 ...... 6.50 6.50 6.50 N 37234 ...... 5.50 5.50 5.50 N 37235 ...... 7.80 7.80 7.80 N 37236 ...... 9.00 8.75 8.75 N 37237 ...... 4.25 4.25 4.25 N 37238 ...... 6.29 6.04 6.04 N 37239 ...... 2.97 2.97 2.97 N 37241 ...... 9.00 8.75 8.75 N

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TABLE 26—VALUATIONS FOR SERVICES MINUS MODERATE SEDATION—Continued

Use HCPCS code G0500 CY 2016 CY 2017 CY 2017 to report CPT code work RVU proposed final work moderate work RVU RVU sedation (Y/N)

37242 ...... 10.05 9.80 9.80 N 37243 ...... 11.99 11.74 11.74 N 37244 ...... 14.00 13.75 13.75 N 37252 ...... 1.80 1.80 1.80 N 37253 ...... 1.44 1.44 1.44 N 43200 ...... 1.52 1.42 1.42 Y 43201 ...... 1.82 1.72 1.72 Y 43202 ...... 1.82 1.72 1.72 Y 43204 ...... 2.43 2.33 2.33 Y 43205 ...... 2.54 2.44 2.44 Y 43206 ...... 2.39 2.29 2.29 Y 43211 ...... 4.30 4.20 4.20 Y 43212 ...... 3.50 3.40 3.40 Y 43213 ...... 4.73 4.63 4.63 Y 43214 ...... 3.50 3.40 3.40 Y 43215 ...... 2.54 2.44 2.44 Y 43216 ...... 2.40 2.30 2.30 Y 43217 ...... 2.90 2.80 2.80 Y 43220 ...... 2.10 2.00 2.00 Y 43226 ...... 2.34 2.24 2.24 Y 43227 ...... 2.99 2.89 2.89 Y 43229 ...... 3.59 3.49 3.49 Y 43231 ...... 2.90 2.80 2.80 Y 43232 ...... 3.69 3.59 3.59 Y 43233 ...... 4.17 4.07 4.07 Y 43235 ...... 2.19 2.09 2.09 Y 43236 ...... 2.49 2.39 2.39 Y 43237 ...... 3.57 3.47 3.47 Y 43238 ...... 4.26 4.16 4.16 Y 43239 ...... 2.49 2.39 2.39 Y 43240 ...... 7.25 7.15 7.15 Y 43241 ...... 2.59 2.49 2.49 Y 43242 ...... 4.83 4.73 4.73 Y 43243 ...... 4.37 4.27 4.27 Y 43244 ...... 4.50 4.40 4.40 Y 43245 ...... 3.18 3.08 3.08 Y 43246 ...... 3.66 3.56 3.56 Y 43247 ...... 3.21 3.11 3.11 Y 43248 ...... 3.01 2.91 2.91 Y 43249 ...... 2.77 2.67 2.67 Y 43250 ...... 3.07 2.97 2.97 Y 43251 ...... 3.57 3.47 3.47 Y 43252 ...... 3.06 2.96 2.96 Y 43253 ...... 4.83 4.73 4.73 Y 43254 ...... 4.97 4.87 4.87 Y 43255 ...... 3.66 3.56 3.56 Y 43257 ...... 4.25 4.15 4.15 Y 43259 ...... 4.14 4.04 4.04 Y 43260 ...... 5.95 5.70 5.85 Y 43261 ...... 6.25 6.00 6.15 Y 43262 ...... 6.60 6.35 6.50 Y 43263 ...... 6.60 6.35 6.50 Y 43264 ...... 6.73 6.48 6.63 Y 43265 ...... 8.03 7.78 7.93 Y 43266 ...... 4.17 3.92 3.92 N 43270 ...... 4.26 4.01 4.01 N 43273 ...... 2.24 2.24 2.24 N 43274 ...... 8.58 8.33 8.48 Y 43275 ...... 6.96 6.71 6.86 Y 43276 ...... 8.94 8.69 8.84 Y 43277 ...... 7.00 6.75 6.90 Y 43278 ...... 8.02 7.77 7.92 Y 43450 ...... 1.38 1.13 1.28 Y 43453 ...... 1.51 1.26 1.41 Y 44360 ...... 2.59 2.49 2.49 Y 44361 ...... 2.87 2.77 2.77 Y 44363 ...... 3.49 3.39 3.39 Y 44364 ...... 3.73 3.63 3.63 Y

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TABLE 26—VALUATIONS FOR SERVICES MINUS MODERATE SEDATION—Continued

Use HCPCS code G0500 CY 2016 CY 2017 CY 2017 to report CPT code work RVU proposed final work moderate work RVU RVU sedation (Y/N)

44365 ...... 3.31 3.21 3.21 Y 44366 ...... 4.40 4.30 4.30 Y 44369 ...... 4.51 4.41 4.41 Y 44370 ...... 4.79 4.69 4.69 Y 44372 ...... 4.40 4.30 4.30 Y 44373 ...... 3.49 3.39 3.39 Y 44376 ...... 5.25 5.15 5.15 Y 44377 ...... 5.52 5.42 5.42 Y 44378 ...... 7.12 7.02 7.02 Y 44379 ...... 7.46 7.36 7.36 Y 44380 ...... 0.97 0.87 0.87 Y 44381 ...... 1.48 1.38 1.38 Y 44382 ...... 1.27 1.17 1.17 Y 44384 ...... 2.95 2.85 2.85 Y 44385 ...... 1.30 1.20 1.20 Y 44386 ...... 1.60 1.50 1.50 Y 44388 ...... 2.82 2.72 2.72 Y 44388–53 ...... 1.41 1.36 1.36 Y 44389 ...... 3.12 3.02 3.02 Y 44390 ...... 3.84 3.74 3.74 Y 44391 ...... 4.22 4.12 4.12 Y 44392 ...... 3.63 3.53 3.53 Y 44394 ...... 4.13 4.03 4.03 Y 44401 ...... 4.44 4.34 4.34 Y 44402 ...... 4.80 4.70 4.70 Y 44403 ...... 5.60 5.50 5.50 Y 44404 ...... 3.12 3.02 3.02 Y 44405 ...... 3.33 3.23 3.23 Y 44406 ...... 4.20 4.10 4.10 Y 44407 ...... 5.06 4.96 4.96 Y 44408 ...... 4.24 4.14 4.14 Y 44500 ...... 0.49 0.39 0.39 Y 45303 ...... 1.50 1.40 1.40 Y 45305 ...... 1.25 1.15 1.15 Y 45307 ...... 1.70 1.60 1.60 Y 45308 ...... 1.40 1.30 1.30 Y 45309 ...... 1.50 1.40 1.40 Y 45315 ...... 1.80 1.70 1.70 Y 45317 ...... 2.00 1.90 1.90 Y 45320 ...... 1.78 1.68 1.68 Y 45321 ...... 1.75 1.65 1.65 Y 45327 ...... 2.00 1.90 1.90 Y 45332 ...... 1.86 1.76 1.76 Y 45333 ...... 1.65 1.55 1.55 Y 45334 ...... 2.10 2.00 2.00 Y 45335 ...... 1.14 1.04 1.04 Y 45337 ...... 2.20 2.10 2.10 Y 45338 ...... 2.15 2.05 2.05 Y 45340 ...... 1.35 1.25 1.25 Y 45341 ...... 2.22 2.12 2.12 Y 45342 ...... 3.08 2.98 2.98 Y 45346 ...... 2.91 2.81 2.81 Y 45347 ...... 2.82 2.72 2.72 Y 45349 ...... 3.62 3.52 3.52 Y 45350 ...... 1.78 1.68 1.68 Y 45378 ...... 3.36 3.26 3.26 Y 45378–53 ...... 1.68 1.63 1.63 Y 45379 ...... 4.38 4.28 4.28 Y 45380 ...... 3.66 3.56 3.56 Y 45381 ...... 3.66 3.56 3.56 Y 45382 ...... 4.76 4.66 4.66 Y 45384 ...... 4.17 4.07 4.07 Y 45385 ...... 4.67 4.57 4.57 Y 45386 ...... 3.87 3.77 3.77 Y 45388 ...... 4.98 4.88 4.88 Y 45389 ...... 5.34 5.24 5.24 Y 45390 ...... 6.14 6.04 6.04 Y 45391 ...... 4.74 4.64 4.64 Y

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TABLE 26—VALUATIONS FOR SERVICES MINUS MODERATE SEDATION—Continued

Use HCPCS code G0500 CY 2016 CY 2017 CY 2017 to report CPT code work RVU proposed final work moderate work RVU RVU sedation (Y/N)

45392 ...... 5.60 5.50 5.50 Y 45393 ...... 4.78 4.68 4.68 Y 45398 ...... 4.30 4.20 4.20 Y 47000 ...... 1.90 1.65 1.65 N 47382 ...... 15.22 14.97 14.97 N 47383 ...... 9.13 8.88 8.88 N 47532 ...... 4.25 4.25 4.25 N 47533 ...... 6.00 5.38 5.38 N 47534 ...... 8.03 7.60 7.60 N 47535 ...... 4.50 3.95 3.95 N 47536 ...... 2.88 2.61 2.61 N 47538 ...... 6.60 4.75 4.75 N 47539 ...... 9.00 8.75 8.75 N 47540 ...... 10.75 9.03 9.03 N 47541 ...... 5.61 5.38 6.75 N 47542 ...... 2.50 2.85 2.85 N 47543 ...... 3.07 3.00 3.00 N 47544 ...... 4.29 3.28 3.28 N 49405 ...... 4.25 4.00 4.00 N 49406 ...... 4.25 4.00 4.00 N 49407 ...... 4.50 4.25 4.25 N 49411 ...... 3.82 3.57 3.57 N 49418 ...... 4.21 3.96 3.96 N 49440 ...... 4.18 3.93 3.93 N 49441 ...... 4.77 4.52 4.52 N 49442 ...... 4.00 3.75 3.75 N 49446 ...... 3.31 3.06 3.06 N 50200 ...... 2.63 2.38 2.38 N 50382 ...... 5.50 5.25 5.25 N 50384 ...... 5.00 4.75 4.75 N 50385 ...... 4.44 4.19 4.19 N 50386 ...... 3.30 3.05 3.05 N 50387 ...... 2.00 1.75 1.75 N 50430 ...... 3.15 2.90 2.90 N 50432 ...... 4.25 4.00 4.00 N 50433 ...... 5.30 5.05 5.05 N 50434 ...... 4.00 3.75 3.75 N 50592 ...... 6.80 6.55 6.55 N 50593 ...... 9.13 8.88 8.88 N 50606 ...... 3.16 3.16 3.16 N 50693 ...... 4.21 3.96 3.96 N 50694 ...... 5.50 5.25 5.25 N 50695 ...... 7.05 6.80 6.80 N 50705 ...... 4.03 4.03 4.03 N 50706 ...... 3.80 3.80 3.80 N 57155 ...... 5.40 5.15 5.15 N 66720 ...... 5.00 4.75 4.75 N 69300 ...... 6.69 6.44 6.44 N 77371 ...... 0.00 0.00 0.00 N 77600 ...... 1.56 1.31 1.31 N 77605 ...... 2.09 1.84 1.84 N 77610 ...... 1.56 1.31 1.31 N 77615 ...... 2.09 1.84 1.84 N 92920 ...... 10.10 9.85 9.85 N 92921 ...... 0.00 0.00 0.00 N 92924 ...... 11.99 11.74 11.74 N 92925 ...... 0.00 0.00 0.00 N 92928 ...... 11.21 10.96 10.96 N 92929 ...... 0.00 0.00 0.00 N 92933 ...... 12.54 12.29 12.29 N 92934 ...... 0.00 0.00 0.00 N 92937 ...... 11.20 10.95 10.95 N 92938 ...... 0.00 0.00 0.00 N 92941 ...... 12.56 12.31 12.31 N 92943 ...... 12.56 12.31 12.31 N 92944 ...... 0.00 0.00 0.00 N 92953 ...... 0.23 0.01 0.01 N 92960 ...... 2.25 2.00 2.00 N

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TABLE 26—VALUATIONS FOR SERVICES MINUS MODERATE SEDATION—Continued

Use HCPCS code G0500 CY 2016 CY 2017 CY 2017 to report CPT code work RVU proposed final work moderate work RVU RVU sedation (Y/N)

92961 ...... 4.59 4.34 4.34 N 92973 ...... 3.28 3.28 3.28 N 92974 ...... 3.00 3.00 3.00 N 92975 ...... 7.24 6.99 6.99 N 92978 ...... 0.00 0.00 0.00 N 92979 ...... 0.00 0.00 0.00 N 92986 ...... 22.85 22.60 22.60 N 92987 ...... 23.63 23.38 23.38 N 93312 ...... 2.55 2.30 2.30 N 93313 ...... 0.51 0.26 0.26 N 93314 ...... 2.10 1.85 1.85 N 93315 ...... 2.94 2.69 2.69 N 93316 ...... 0.85 0.60 0.60 N 93317 ...... 2.09 1.84 1.84 N 93318 ...... 2.40 2.15 2.15 N 93451 ...... 2.72 2.47 2.47 N 93452 ...... 4.75 4.50 4.50 N 93453 ...... 6.24 5.99 5.99 N 93454 ...... 4.79 4.54 4.54 N 93455 ...... 5.54 5.29 5.29 N 93456 ...... 6.15 5.90 5.90 N 93457 ...... 6.89 6.64 6.64 N 93458 ...... 5.85 5.60 5.60 N 93459 ...... 6.60 6.35 6.35 N 93460 ...... 7.35 7.10 7.10 N 93461 ...... 8.10 7.85 7.85 N 93462 ...... 3.73 3.73 3.73 N 93463 ...... 2.00 2.00 2.00 N 93464 ...... 1.80 1.80 1.80 N 93505 ...... 4.37 4.12 4.12 N 93530 ...... 4.22 3.97 3.97 N 93561 ...... 0.50 0.25 0.25 N 93562 ...... 0.16 0.01 0.01 N 93563 ...... 1.11 1.11 1.11 N 93564 ...... 1.13 1.13 1.13 N 93565 ...... 0.86 0.86 0.86 N 93566 ...... 0.86 0.86 0.86 N 93567 ...... 0.97 0.97 0.97 N 93568 ...... 0.88 0.88 0.88 N 93571 ...... 0.00 0.00 0.00 N 93572 ...... 0.00 0.00 0.00 N 93582 ...... 12.56 12.31 12.31 N 93583 ...... 14.00 13.75 13.75 N 93609 ...... 0.00 0.00 0.00 N 93613 ...... 6.99 6.99 6.99 N 93615 ...... 0.99 0.74 0.74 N 93616 ...... 1.49 1.24 1.24 N 93618 ...... 4.25 4.00 4.00 N 93619 ...... 7.31 7.06 7.06 N 93620 ...... 11.57 11.32 11.32 N 93621 ...... 0.00 0.00 0.00 N 93622 ...... 0.00 0.00 0.00 N 93624 ...... 4.80 4.55 4.55 N 93640 ...... 3.51 3.26 3.26 N 93641 ...... 5.92 5.67 5.67 N 93642 ...... 4.88 4.63 4.63 N 93644 ...... 3.29 3.04 3.04 N 93650 ...... 10.49 10.24 10.24 N 93653 ...... 15.00 14.75 14.75 N 93654 ...... 20.00 19.75 19.75 N 93655 ...... 7.50 7.50 7.50 N 93656 ...... 20.02 19.77 19.77 N 93657 ...... 7.50 7.50 7.50 N 94011 ...... 2.00 1.75 1.75 N 94012 ...... 3.10 2.85 2.85 N 94013 ...... 0.66 0.41 0.41 N 96440 ...... 2.37 2.12 2.12 N G0105 ...... 3.36 3.26 3.26 Y

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TABLE 26—VALUATIONS FOR SERVICES MINUS MODERATE SEDATION—Continued

Use HCPCS code G0500 CY 2016 CY 2017 CY 2017 to report CPT code work RVU proposed final work moderate work RVU RVU sedation (Y/N)

G0105–53 ...... 1.68 1.63 1.63 Y G0121 ...... 3.36 3.26 3.26 Y G0121–53 ...... 1.68 1.63 1.63 Y G0341 ...... 6.98 6.98 6.98 N

(58) Prolonged Evaluation and proposed to adopt the RUC- 88305. Using the RUC-recommended Management Services (CPT Codes recommended work RVUs of 1.00 for RVU of 4.00 results in a higher IWPUT, 99354, 99358, and 99359) CPT code 99487 and 0.50 for CPT code and we did not believe there is a We previously received RUC 99489, as well as direct PE inputs difference in work intensity between recommendations for face-to-face and consistent with the RUC these codes. Therefore for CY 2017, we non-face-to-face prolonged E/M recommendations. proposed a work RVU of 3.60 for HCPCS services. In response to the request for We received no comments on the code G0416. public comments in the CY 2016 PFS valuation of CPT codes 99487 and Comment: A few commenters, proposed rule about improving payment 99489; therefore, we are finalizing as including the RUC, stated their accuracy for cognitive services, proposed. objection to the methodology used in proposing a value for this HCPCS code commenters suggested that we consider (60) Prostate Biopsy, Any Method along with the proposed work RVU. The making separate payment for CPT codes (HCPCS Code G0416) RUC stated its disagreement with what 99358 and 99359. As reflected in section The College of American Pathologists II.E, we proposed to make separate it called a formulaic approach of and the American Society of multiplying time by intensity to arrive payment for these services. Cytopathology formed an expert panel We also proposed values for services at a value for this code. The RUC, along to make recommendations at the in this family of codes based on the with other commenters, also urged CMS October 2015 RUC meeting to determine RUC-recommended values, including to accept the compelling evidence that an appropriate work RVU for HCPCS for CPT code 99354, which would G0416 and 88305 have an anomalous code G0416, as they believed that the increase the current work RVU to 2.33. relationship as a pathologist may survey results were invalid. The panel Likewise, we proposed to adopt the examine 30–60 slides when furnishing made several arguments to the RUC in RUC-recommended work RVU of 2.10 HCPCS code G0416 whereas only one recommending a higher work RVU for CPT code 99358 and 1.00 for CPT slide is examined with CPT code 88305. under the RUC’s ‘‘compelling evidence’’ code 99359. The commenters also noted that CMS Comment: One commenter standard. These arguments were: (1) had previously stated its belief that the recommended that CMS develop That incorrect assumptions were made typical number of specimens evaluated separate payment for a modifier and in previous valuations; (2) the value of for prostate biopsies was between 10 new G-codes that would account for HCPCS code G0416 remained constant and 12, and therefore, would value the additional non-face-to-face time spent while the code descriptors changed over typical G0416 at 9.00 RVUs (0.75 x 12), on circumstances that fell outside that the years; and (3) the ‘‘anomalous if the number of specimens were used of a typical level-4 patient. relationship’’ between HCPCS code rather than a time ratio. Response: We appreciate the G0416 and CPT code 88305 (Level IV— Response: We continue to believe recommendation and will consider Surgical pathology, gross and HCPCS code G0416 should not be coding alternatives in future microscopic examination). The expert valued as a direct crosswalk from CPT rulemaking. panel recommended a work RVU of 4.00 code 38240. CPT code 38240 involves Comment: Many commenters were based on a crosswalk from CPT code the intense monitoring of a patient’s very supportive of CMS’ proposal to pay 38240 (Hematopoietic progenitor cell reactions to a critical infusion of cellular separately for CPT codes 99258 and (HPC); allogeneic transplantation per material. This process does not allow 99359, and to increase the current work donor). The RUC agreed with the the physician to leave the patient. We RVU for CPT code 99354. recommendation of the expert panel. do not believe the time, effort, and Response: We thank commenters for We believed HCPCS code G0416 intensity required of this procedure is their support, and are finalizing the should not be valued as a direct similar to a physician reviewing slides. values as proposed. crosswalk from CPT code 38240. While examining slides, it is possible Instead, since code G0416 describes for the physician to stop, refer to (59) Complex Chronic Care Management services that would otherwise be references, complete other tasks, and Services (CPT Codes 99487 and 99489) reported using CPT code 88305 we return to the slides. Thus the service We received RUC recommendations believed that G0416 should be valued does not have analogous or comparable for CPT codes 99487 and 99489 relative to CPT code 88305. To value intensity. following the October 2012 RUC HCPCS code G0416, we used the intra- We believe the vignette for CPT code meeting, however we considered these service time ratio between HCPCS code 88305 typically involves, by definition, services bundled and did not make G0416 and CPT code 88305 to arrive at two blocks and resulting slides. Based separate payment. For CY 2017, we a work RVU of 3.60. To further support upon that rationale, CMS values each proposed to change the procedure status this method, we noted that the IWPUT block (and resulting slides) as worth a for CPT codes 99487 and 99489 from B for HCPCS code G0416 with a work work RVU of 0.375. Valuing the RVUs (bundled) to A (active), see II.E, and RVU of 3.60 is the same as CPT code on a per block basis, then a sextant

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(typical 10–12 blocks or slides) would accuracy of services for individuals with per minute work RVUs for the highest result in 5 times 0.375 to 6 times 0.375. disabilities. volume codes typically billed by Therefore, for CY 2017 we are finalizing Comment: Several commenters noted psychiatrists, since the resource costs of a work RVU of 3.60 for HCPCS G0416. that the Americans with Disabilities Act the consultant’s work is being paid to (ADA) provides federal tax credits for the primary practitioner. Since the (61) Resource-Intensive Services certain physicians to help cover the cost behavioral health care manager in the (HCPCS Code G0501) of specialized equipment for patients services described by HCPCS codes As discussed in section II.E. of this with mobility-related disabilities. G0502, G0503, and G0504 should have final rule, we proposed to establish Response: We remind practitioners specialized training in behavioral payment for services furnished to that there are existing IRS tax credits health, we proposed a new clinical labor patients with mobility-related and deductions to assist business with type for the behavioral health care disabilities, through a new add-on complying with the ADA. More manager, L057B, at $0.57 per minute, G-code, to be billable with office/ information on these tax credits is based on the rates for genetic counselors outpatient E/M and TCM codes. Based available at https://www.ada.gov/ in the direct PE input database. We on our analysis of the resources taxcred.htm. solicited comment on all aspects of typically involved in furnishing office (62) Behavioral Health Integration: these proposed valuations. visits to patients with these needs Psychiatric Collaborative Care Model Comment: Some commenters stated (especially including the typical (HCPCS Codes G0502, G0503, and that the work of the psychiatric additional practitioner and staff time), G0504) and General Behavioral Health consultant should be valued at least the we believed that the physician work and Integration (HCPCS Code G0507) same as the primary care practitioner. time for HCPCS code G0501 was most For CY 2017, we proposed to establish Commenters noted that the crosswalk to accurately valued through a direct and make separate Medicare payment CPT code 90836 was inaccurate, as the crosswalk from CPT code 99212 (Level using four new HCPCS G-codes, G0502 work of the psychiatric consultant 2 office or other outpatient visit for the (Initial psychiatric collaborative care would not be similar to psychotherapy evaluation and management of an management, first 70 minutes in the first but instead be similar to E/M services. established patient). Therefore, we calendar month of behavioral health Commenters recommended that CMS proposed a work RVU of 0.48 and a care manager activities, in consultation value the work of the psychiatric physician time of 16 minutes for HCPCS with a psychiatric consultant, and consultant through a crosswalk to a code G0501. We sought comment on directed by the treating physician or level-4 outpatient E/M, such as CPT whether these work and time values other qualified health care professional), codes 99204 or 99214. accurately capture the additional G0503 (Subsequent psychiatric Response: We thank commenters for physician work typically involved in collaborative care management, first 60 their response and for providing CMS furnishing services to patients with minutes in a subsequent month of with additional perspectives on mobility impairments. behavioral health care manager appropriate valuation of the work We believed that a direct crosswalk to activities, in consultation with a furnished by the psychiatric consultant. the clinical staff time associated with psychiatric consultant, and directed by We note that for HCPCS codes G0502, CPT code 99212, which is 27 minutes of the treating physician or other qualified G0503, and G0504, Medicare is making LN/LPN/MTA (L037D) accurately health care professional), G0504 (Initial payment to the billing practitioner on represented the additional clinical staff or subsequent psychiatric collaborative the basis that he or she is incurring the time required to furnish an outpatient care management, each additional 30 costs associated with retaining the office visit or TCM to a patient with a minutes in a calendar month of psychiatric consultant. In general, we mobility-related disability. We also behavioral health care manager consider such costs to be appropriately proposed to include as direct PE inputs activities, in consultation with a categorized under the PE RVUs, 27 minutes for a stretcher (EF018) and psychiatric consultant, and directed by regardless of the degree of expertise for a high/low table (EF028), and 27 the treating physician or other qualified that particular contributor. Historically minutes for new equipment inputs health care professional), and G0507 these costs have been included in the associated with the following: A patient (Care management services for calculation of PE RVUs and lift system, wheelchair accessible scale, behavioral health conditions, at least 20 incorporated as costs based on a and padded leg support positioning minutes of clinical staff time, directed national per minute payment rate for system. These items were included in by a physician or other qualified health that kind of labor instead of varying the CY 2017 proposed direct PE input care professional time, per calendar based on which service is furnished. database. We sought comments on month) for collaborative care and care However, we recognize the unique whether these inputs are appropriate, management for beneficiaries with nature of the services described by this and whether any additional inputs are behavioral health conditions, as detailed code, especially with regard to the typically used in treating patients with in section II.E of this final rule. To value potential inclusion of the work of a mobility impairments. HCPCS codes G0502, G0503, and physician as PE. We also recognize that Comment: Many commenters G0504, we proposed to base the portion the work of the psychiatrist under this supported the proposed valuation of of the work RVU that accounts for the model of care more closely resembles G0501 and recommend we finalize as work of the treating physician or other E/M work than that of psychotherapy, proposed, while others had questions or qualified health care professional on a although not necessarily the work concerns about the crosswalk and the direct crosswalk to the proposed work associated with a level-4 office visit. inputs. values for the complex CCM codes, CPT Therefore, for CY 2017, we are finalizing Response: As noted in section II.E.6. codes 99487 and 99489. To value the work RVUs for these services that reflect of this final rule, we are not finalizing portion of the work RVU that accounts the per minute intensity of payment for HCPCS code G0501 for CY for the psychiatric consultant, we E/M services instead of psychotherapy 2017. We will continue to welcome estimated 10 minutes of psychiatric for the portion of the overall work RVU recommendations from stakeholders on consultant time per patient per month attributable to the psychiatric methods for improving the payment and a work RVU of 0.42, based on the consultant.

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We welcome any information on the describing E/M services furnished in an for HCPCS code G0507, we proposed to best way to account for the work, time, inpatient hospital setting versus those use clinical labor type L045C, which is and practice expense resource costs services furnished in an office setting. the labor type for social workers/ associated with two physicians when For this reason, we are not developing psychologists and has a rate of $0.45 per one physician is typically incurring the separate facility and non-facility work minute. resource costs of another. We are RVUs here. Comment: Many commenters stated particularly interested in information Comment: With regard to G0503, a that 20 minutes of care manager time regarding how CoCM might apply for few commenters stated that the over the course of a month was an beneficiaries receiving care in an allocation of 60 minutes is inaccurate representation of the institutional or inpatient setting. inappropriate because a comprehensive resource costs incurred when furnishing We believe that the work associated follow up would take longer than 60 BHI services, and that a longer duration with the billing practitioner would minutes. was needed to fully reflect the time and overall be greater than the work Response: As these are temporary resources associated with providing this associated with the psychiatric codes designed to facilitate one year of care. A few commenters stated that CMS consultant. The work of the billing separate payment prior to receiving a should create an add-on code for HCPCS practitioner includes services such as RUC recommendations through CMS’ code G0507 to account for any broader care management, direction of standard process and we continue to additional time. the care manager, and by ‘‘incident to’’ believe that 60 minutes would be Response: We proposed HCPCS code rules, the general supervision of other typical of the time involved, we will not G0507 to make separate payment for staff, while the psychiatric consultant be making adjustments to the time other kinds of BHI and we are primarily conducts review work. values at this time. We remind concerned that an increased time Therefore, in allocating differential commenters that PFS direct PE inputs threshold may not be typical across the portion of the work RVU to each are used for calculation of rates that we range of services captured by G0507 and practitioner, we believe the work RVU believe reflect the typical case for a may present an additional barrier to associated with the billing practitioner service, and are not intended to be appropriate utilization for some models should be greater than the work RVU instructive to providers as to what is of care. We continue to be interested in associated with the psychiatric permitted under the code or what information from stakeholders regarding consultant. should be furnished in any particular other models of BHI, including those After considering these comments, we case. We also wish to remind that have longer associated times than are finalizing total work RVUs of 1.70 commenters that we have longstanding are accurately captured by HCPCS code for G0502, 1.53 for G0503, and 0.82 for interest in robust extant data sources G0507. G0504. These RVUs include 0.52 for the regarding times, and as these services Comment: A few commenters psychiatric consultant based on a continue to be furnished to Medicare recommended that CMS include the crosswalk to the work per minute of a beneficiaries, we would encourage same clinical staff in HCPCS code level three established patient office stakeholders to develop sets of such G0507 as is included in HCPCS codes visit. data that we could potentially use in G0502, G0503, and G0504 because the Comment: One commenter urged valuation, among other things. complexity in care management would CMS to consider the forthcoming RUC Comment: One commenter likely to be consistent across all four recommendations. recommended that CMS pay separately codes. Response: We thank the commenter for tools, such as multidimensional Response: We agree with commenters, for their suggestion and will evaluate mental health monitoring tools, to assist and will finalize 20 minutes of the RUC’s recommendation according to practitioners in data analysis. behavioral health care manager, L057B, our established review process in future Response: The CoCM model does not time for HCPCS code G0507. rulemaking. make reference to any specific health After considering these comments, we Comment: A few commenters monitoring tools; therefore, we will not are finalizing a total work RVU of 0.61 requested that CMS increase the facility be including those as direct PE inputs for G0507. setting PE RVUs, as patients in this in our valuation of these services. setting are more complex, and therefore, To value HCPCS code G0507, we (63) Comprehensive Assessment and the care manager would need to be more proposed a work RVU of 0.61 based on Care Planning for Patients With experienced. The extra costs in terms of a direct crosswalk from CPT code 99490 Cognitive Impairment (HCPCS Code clinical staff, commenters stated, would (Chronic care management services). We G0505) offset the decrease in other kinds of PE recognize that the services described by For CY 2017, we proposed to create associated with the facility setting. CPT code 99490 are distinct from those and pay separately for new HCPCS code Response: The clinical labor costs for furnished under the CoCM and we G0505 (Cognition and functional PFS are generally included in the believe that these also vary based on assessment using standardized nonfacility rate but not included in the different kinds of BHI care. We note that instruments with development of facility rate under the PFS, because there are relatively few existing codes recorded care plan for the patient with applicable payment for the clinical labor that describe these kinds of services cognitive impairment, history face-to- costs would be made under the over a calendar month. We also believe face obtained from patient and/or appropriate institutional payment that the resources associated with CPT caregiver, in office or other outpatient system, like the OPPS. Historically we code 99490 may vary based on the ways setting or home or domiciliary or rest have not developed separate work RVUs different practitioners furnish the home), see II.E for further discussion. for the facility and the non-facility service. Until we have more information Based on similarities between work setting for the same codes. The only about how the services described by intensity and time, we believe that the cases where we have differentiated work G0507 are typically furnished, we physician work and time for this code between an institutional and a non- believe valuation based on an estimate would be accurately valued by institutional setting are when the of the typical resources would be most combining the work RVUs from CPT HCPCS codes delineate between them, appropriate. To account for the care code 99204 (Level 4 office or other for example site specific codes manager minutes in the direct PE inputs outpatient visit for the evaluation and

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management of a new patient) and half cognitive function; identify caregiver requiring critical care services, such as the work RVUs for HCPCS code G0181 and explain assessment’’ as we believe a stroke patient. We noted that due to (Physician supervision of a patient 4 minutes is a more typical time limited coding granularity for high- receiving Medicare-covered services associated with this task. intensity cognitive services, in the PFS, furnished by a participating home we did not believe there is an intuitive (64) Comprehensive Assessment and health agency (patient not present) crosswalk code for ideal estimation of Care Planning for Patients Requiring requiring complex and the work and time values for G0508. In Chronic Care Management (HCPCS multidisciplinary care modalities general, we believed that the overall Code G0506) involving regular physician work for G0508 is not as great as 99291 development and/or revision of care For CY 2017, we proposed to make (Critical care, evaluation and plans, review of subsequent reports of payment for the resource costs of management of the critically ill or patient status, review of laboratory and comprehensive assessment and care critically injured patient; first 30–74 other studies, communication planning for patients requiring CCM minutes) but that the service involves (including telephone calls) with other services through HCPCS code G0506 as more work than HCPCS code G0427 health care professionals involved in the an add-on code to be billed with the (Telehealth consultation, emergency patient’s care, integration of new initiating visit for CCM for patients that department or initial inpatient, typically information into the medical treatment require extensive assessment and care 70 minutes or more communicating plan and/or adjustment of medical planning (see section II.E). In valuing with the patient via telehealth). We therapy, within a calendar month, 30 this code, we believed that a crosswalk believe that G0508 is most accurately minutes or more). Therefore, we to half the work and time values of valued by a crosswalk to the work RVU proposed a work RVU of 3.30. HCPCS code G0181 (Physician and physician intra-service time of CPT For direct PE inputs we proposed 70 supervision of a patient receiving code 38240 (Hematopoietic progenitor total minutes of time for RN/LPN/MTA Medicare-covered services provided by cell (HPC); allogeneic transplantation (L037D). We believed this was typical a participating home health agency per donor). Therefore, we proposed a based on information from several (patient not present) requiring complex work RVU of 4.0 and solicited comment specialty societies representing and multidisciplinary care modalities on the accuracy of these assumptions. practitioners who typically furnish this involving regular physician We did not believe that direct PE inputs service and report, it, when appropriate, development and/or revision of care would typically be involved with using E/M codes. We solicited comment plans, review of subsequent reports of furnishing this service from the distant on these valuation assumptions and patient status, review of laboratory and site. For G0509 we proposed a work welcomed additional information on the other studies, communication RVU of 3.86 based on a crosswalk from work and direct PE associated with (including telephone calls) with other G0427. We believed that G0427 has furnishing this service. health care professionals involved in the similar overall work intensity to G0509 Comment: One commenter stated that patient’s care, integration of new and has a similar intraservice time. We to more accurately reflect the reality of information into the medical treatment also believed that no direct PE inputs the case complexity involved in plan and/or adjustment of medical would typically be associated with assessment and care planning for therapy, within a calendar month, 30 furnishing this service from the distant patients with cognitive impairment, that minutes or more) accurately accounts site. the work RVU should be based on at for the time and intensity of the work Comment: Many commenters least a Level 5 office visit with associated with furnishing this service supported the proposal, saying the recognition that the work required is over and above the work accounted for codes will improve patient outcomes likely 1.5 times to two times greater as part of the separately billed initiating and quality of care. than a Level 5 visit. Furthermore, the visit. Therefore, we proposed a work Response: We thank commenters for commenter stated that 120 minutes was RVU of 0.87 and 29 minutes of their support. We are finalizing the a more appropriate time value. Many physician time. We also proposed 36 work RVUs for new HCPCS codes other commenters encouraged CMS to minutes for a RN/LPN/MTA (L037D) as G0508 and G0509 as proposed. accept the RUC-recommended values the only direct PE input for this service. Comment: A few commenters for this code, presented at the April Comment: Many commenters encouraged CMS to recognize critical 2016 RUC meeting. The AMA RUC supported the proposed work and PE care as a telehealth service rather than submitted the recommendation of a values. create G-codes to facilitate payment. work RVU of 3.44 as part of its public Response: We thank commenters for Commenters also stated that the comment. supporting physician work and PE complex nature of patients requiring Response: After reviewing values inputs for G0506 and we are finalizing critical care services necessitates the recommended by the RUC in its as proposed. codes be billed more than once per day. comment, we are persuaded that many Response: We continue to believe that elements of its valuation accurately (65) Telehealth Consultation for a the telehealth consultation model, capture the resource costs associated Patient Requiring Critical Care Services including the limit on billing more than with the provision of this service. (HCPCS Codes G0508and G0509) once per day, is more appropriate than Therefore, we are finalizing the As discussed in section II.C, we the model used to describe the in- physician work and time values in proposed use of new HCPCS G-codes, person critical care E/Ms. In general we consideration of these comments as G0508 (Telehealth consultation, critical believe that the complex nature of recommended. We are finalizing a work care, physicians typically spend 60 patients requiring critical care is RVU of 3.44 as recommended by the minutes communicating with the described by in-person critical care RUC. We are removing 2 minutes of the patient via telehealth (initial) and G0509 E/Ms, which includes services that 6 recommended clinical staff time for (Telehealth consultation, critical care, cannot be furnished via remote the task ‘‘Gather and review X-ray, lab, physicians typically spend 50 minutes communication technology. pathology reports and prepare for communicating with the patient via Furthermore, we believe that the physician review; conduct initial phone telehealth (subsequent)), to report telehealth consultation model, call for preliminary assessment of telehealth consultations for a patient including the limit on billing more than

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once per day, appropriately captures the Response: We appreciate the 60 minutes communicating with the kind of work described as remote, comments and, in order to make it clear patient and providers via telehealth critical consultations for critical care that the consultation could include (initial). patients. conversations with other providers and • G0509: Telehealth consultation, Comment: A few commenters caregivers if the patient is unable to critical care, physicians typically spend suggested that CMS clarify that the communicate, we will finalize the 50 minutes communicating with the consulting doctor could communicate following code descriptors: with staff or family members if the • G0508: Telehealth consultation, patient and providers via telehealth patient was unable to communicate. critical care, physicians typically spend (subsequent).

TABLE 27—FINALIZED CY 2017 WORK RVUS FOR NEW, REVISED AND POTENTIALLY MISVALUED CODES

Proposed CY CMS Work HCPCS Code Long Descriptor CY 2016 2017 Work Final CY 2017 time Work RVU RVU Work RVU refinement

00740 ...... Anesthesia for upper gastrointestinal endoscopic proce- 0.00 0.00 0.00 No. dures, endoscope introduced proximal to duodenum. 00810 ...... Anesthesia for lower intestinal endoscopic procedures, en- 0.00 0.00 0.00 No. doscope introduced distal to duodenum. 10035 ...... Placement of soft tissue localization device(s) (eg, clip, 1.70 1.70 1.70 No. metallic pellet, wire/needle, radioactive seeds), percutaneous, including imaging guidance; first lesion. 10036 ...... Placement of soft tissue localization device(s) (eg, clip, 0.85 0.85 0.85 No. metallic pellet, wire/needle, radioactive seeds), percutaneous, including imaging guidance; each additional lesion. 11730 ...... Avulsion of nail plate, partial or complete, simple; single ... 1.10 1.05 1.05 No. 11732 ...... Avulsion of nail plate, partial or complete, simple; each 0.44 0.38 0.38 Yes. additional nail plate. 20245 ...... Biopsy, bone, open; deep (eg, humerus, ischium, femur) .. 8.95 6.00 6.00 No. 20550 ...... Injection(s); single tendon sheath, or ligament, 0.75 0.75 0.75 No. aponeurosis (eg, plantar ‘‘fascia’’). 20552 ...... Injection(s); single or multiple trigger point(s), 1 or 2 mus- 0.66 0.66 0.66 No. cle(s). 20553 ...... Injection(s); single or multiple trigger point(s), 3 or more 0.75 0.75 0.75 No. muscles. 22853 ...... Insertion of interbody biomechanical device(s) (eg, syn- NEW 4.25 4.25 No. thetic cage, mesh) with integral anterior instrumentation for device anchoring (eg, screws, flanges) when performed to intervertebral disc space in conjunction with interbody arthrodesis, each interspace. 22854 ...... Insertion of intervertebral biomechanical device(s) (eg, NEW 5.50 5.50 No. synthetic cage, mesh) with integral anterior instrumentation for device anchoring (eg, screws, flanges) when performed to vertebral corpectomy(ies) (vertebral body resection, partial or complete) defect, in conjunction with interbody arthrodesis, each contiguous defect. 22859 ...... Insertion of intervertebral biomechanical device(s) (eg, NEW 5.50 5.50 No. synthetic cage, mesh, methylmethacrylate) to intervertebral disc space or vertebral body defect without interbody arthrodesis, each contiguous defect. 22867 ...... Insertion of interlaminar/interspinous process stabilization/ NEW 13.50 13.50 No. distraction device, without fusion, including image guidance when performed, with open decompression, lumbar; single level. 22868 ...... Insertion of interlaminar/interspinous process stabilization/ NEW 4.00 4.00 No. distraction device, without fusion, including image guidance when performed, with open decompression, lumbar; second level. 22869 ...... Insertion of interlaminar/interspinous process stabilization/ NEW 7.03 7.03 No. distraction device, without open decompression or fusion, including image guidance when performed, lumbar; single level. 22870 ...... Insertion of interlaminar/interspinous process stabilization/ NEW 2.34 2.34 No. distraction device, without open decompression or fusion, including image guidance when performed, lumbar; second level. 26356 ...... Repair or advancement, flexor tendon, in zone 2 digital 9.56 9.56 9.56 No. flexor tendon sheath (eg, no man’s land); primary, without free graft, each tendon. 26357 ...... Repair or advancement, flexor tendon, in zone 2 digital 10.53 11.00 11.00 No. flexor tendon sheath (eg, no man’s land); secondary, without free graft, each tendon.

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TABLE 27—FINALIZED CY 2017 WORK RVUS FOR NEW, REVISED AND POTENTIALLY MISVALUED CODES—Continued

Proposed CY CMS Work HCPCS Code Long Descriptor CY 2016 2017 Work Final CY 2017 time Work RVU RVU Work RVU refinement

26358 ...... Repair or advancement, flexor tendon, in zone 2 digital 12.13 12.60 12.60 No. flexor tendon sheath (eg, no man’s land); secondary, with free graft (includes obtaining graft), each tendon. 27197 ...... Closed treatment of posterior pelvic ring fracture(s), dis- NEW 1.53 1.53 Yes. location(s), diastasis or subluxation of the ilium, sacro- iliac joint, and/or sacrum, with or without anterior pelvic ring fracture(s) and/or dislocation(s) of the pubic sym- physis and/or superior/inferior rami, unilateral or bilateral; without manipulation. 27198 ...... Closed treatment of posterior pelvic ring fracture(s), dis- NEW 4.75 4.75 Yes. location(s), diastasis or subluxation of the ilium, sacro- iliac joint, and/or sacrum, with or without anterior pelvic ring fracture(s) and/or dislocation(s) of the pubic sym- physis and/or superior/inferior rami, unilateral or bilateral; with manipulation, requiring more than local anesthesia (i.e., general anesthesia, moderate sedation, spinal/epidural). 28289 ...... Hallux rigidus correction with cheilectomy, debridement 8.31 6.90 6.90 No. and capsular release of the first metatarsophalangeal joint. 28291 ...... Hallux rigidus correction with cheilectomy, debridement NEW 7.81 8.01 No. and capsular release of the first metatarsophalangeal joint; with implant. 28292 ...... Correction, hallux valgus (bunion), with or without 9.05 7.44 7.44 No. sesamoidectomy; Keller, McBride, or Mayo type procedure. 28295 ...... Correction, hallux valgus (bunionectomy), with NEW 8.25 8.57 No. sesamoidectomy, when performed; with proximal metatarsal osteotomy, any method. 28296 ...... Correction, hallux valgus (bunion), with or without 8.35 8.25 8.25 No. sesamoidectomy; with metatarsal osteotomy (eg, Mitch- ell, Chevron, or concentric type procedures). 28297 ...... Correction, hallux valgus (bunion), with or without 9.43 9.29 9.29 No. sesamoidectomy; Lapidus-type procedure. 28298 ...... Correction, hallux valgus (bunion), with or without 8.13 7.75 7.75 No. sesamoidectomy; by phalanx osteotomy. 28299 ...... Correction, hallux valgus (bunion), with or without 11.57 9.29 9.29 No. sesamoidectomy; by double osteotomy. 31500 ...... Intubation, endotracheal, emergency procedure ...... 2.33 2.66 3.00 No. 31551 ...... Laryngoplasty; for laryngeal stenosis, with graft, without NEW 21.50 21.50 No. indwelling stent placement, younger than 12 years of age. 31552 ...... Laryngoplasty; for laryngeal stenosis, with graft, without NEW 20.50 20.50 No. indwelling stent placement, age 12 years or older. 31553 ...... Laryngoplasty; for laryngeal stenosis, with graft, with in- NEW 22.00 22.00 No. dwelling stent placement, younger than 12 years of age. 31554 ...... Laryngoplasty; for laryngeal stenosis, with graft, with in- NEW 22.00 22.00 No. dwelling stent placement, age 12 years or older. 31572 ...... Laryngoscopy, flexible; with ablation or destruction of le- NEW 3.01 3.01 No. sion(s) with laser, unilateral. 31573 ...... Laryngoscopy, flexible; with therapeutic injection(s) (eg, NEW 2.43 2.43 No. chemodenervation agent or corticosteroid, injected percutaneous, transoral, or via endoscope channel), unilateral. 31574 ...... Laryngoscopy, flexible; with injection(s) for augmentation NEW 2.43 2.43 No. (eg, percutaneous, transoral), unilateral. 31575 ...... Laryngoscopy, flexible fiberoptic; diagnostic ...... 1.10 0.94 0.94 No. 31576 ...... Laryngoscopy, flexible fiberoptic; with biopsy ...... 1.97 1.89 1.89 No. 31577 ...... Laryngoscopy, flexible fiberoptic; with removal of foreign 2.47 2.19 2.19 No. body. 31578 ...... Laryngoscopy, flexible fiberoptic; with removal of lesion .... 2.84 2.43 2.43 No. 31579 ...... Laryngoscopy, flexible or rigid fiberoptic, with stroboscopy 2.26 1.88 1.88 No. 31580 ...... Laryngoplasty; for laryngeal web, 2-stage, with keel inser- 14.66 14.60 14.60 No. tion and removal. 31584 ...... Laryngoplasty; with open reduction of fracture ...... 20.47 17.58 17.58 No. 31587 ...... Laryngoplasty, cricoid split ...... 15.27 15.27 15.27 No. 31591 ...... Laryngoplasty, medialization; unilateral ...... NEW 13.56 13.56 No. 31592 ...... Cricotracheal resection ...... NEW 25.00 25.00 No.

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TABLE 27—FINALIZED CY 2017 WORK RVUS FOR NEW, REVISED AND POTENTIALLY MISVALUED CODES—Continued

Proposed CY CMS Work HCPCS Code Long Descriptor CY 2016 2017 Work Final CY 2017 time Work RVU RVU Work RVU refinement

33340 ...... Percutaneous transcatheter closure of the left atrial ap- NEW 13.00 14.00 No. pendage with endocardial implant, including fluoroscopy, transseptal puncture, catheter placement(s), left atrial angiography, left atrial appendage angiography, when performed, and radiological supervision and interpretation. 33390 ...... Valvuloplasty, aortic valve, open, with cardiopulmonary by- NEW 35.00 35.00 No. pass; simple (i.e., valvotomy, debridement, debulking and/or simple commissural resuspension). 33391 ...... Valvuloplasty, aortic valve, open, with cardiopulmonary by- NEW 41.50 41.50 No. pass; complex (eg, leaflet extension, leaflet resection, leaflet reconstruction or annuloplasty). 36440 ...... Push transfusion, blood, 2 years or younger ...... 1.03 1.03 1.03 No. 36450 ...... Exchange transfusion, blood; newborn ...... 2.23 3.50 3.50 No. 36455 ...... Exchange transfusion, blood; other than newborn ...... 2.43 2.43 2.43 No. 36456 ...... Partial exchange transfusion, blood, plasma or crystalloid NEW 2.00 2.00 No. necessitating the skill of a physician or other qualified health care professional, newborn. 36473 ...... Endovenous ablation therapy of incompetent vein, extrem- NEW 3.50 3.50 No. ity, inclusive of all imaging guidance and monitoring, percutaneous, mechanochemical; first vein treated. 36474 ...... Endovenous ablation therapy of incompetent vein, extrem- NEW 1.75 1.75 No. ity, inclusive of all imaging guidance and monitoring, percutaneous, mechanochemical; subsequent vein(s) treated in a single extremity, each through separate access sites. 36901 ...... Introduction of needle(s) and/or catheter(s), dialysis circuit, NEW 2.82 2.82 No. with diagnostic angiography of 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, radiologic supervision and interpretation and image documentation and report. 36902 ...... Introduction of needle(s) and/or catheter(s), dialysis circuit, NEW 4.24 4.24 No. with diagnostic angiography of 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, radiologic supervision and interpretation and image documentation and report; with transluminal balloon angioplasty, peripheral dialysis segment, including all imaging and radiological supervision and interpretation necessary to perform the angioplasty. 36903 ...... Introduction of needle(s) and/or catheter(s), dialysis circuit, NEW 5.85 5.85 No. with diagnostic angiography of 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, radiologic supervision and interpretation and image documentation and report; with transcatheter placement of intravascular stent(s) peripheral dialysis segment, including all imaging and radiological supervision and interpretation necessary to perform the stenting, and all angioplasty within the peripheral dialysis segment. 36904 ...... Percutaneous transluminal mechanical thrombectomy and/ NEW 6.73 6.73 No. or infusion for thrombolysis, dialysis circuit, any method, including all imaging and radiological supervision and interpretation, diagnostic angiography, fluoroscopic guidance, catheter placement(s), and intraprocedural pharmacological thrombolytic injection(s).

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TABLE 27—FINALIZED CY 2017 WORK RVUS FOR NEW, REVISED AND POTENTIALLY MISVALUED CODES—Continued

Proposed CY CMS Work HCPCS Code Long Descriptor CY 2016 2017 Work Final CY 2017 time Work RVU RVU Work RVU refinement

36905 ...... Percutaneous transluminal mechanical thrombectomy and/ NEW 8.46 8.46 No. or infusion for thrombolysis, dialysis circuit, any method, including all imaging and radiological supervision and interpretation, diagnostic angiography, fluoroscopic guidance, catheter placement(s), and intraprocedural pharmacological thrombolytic injection(s); with transluminal balloon angioplasty, peripheral dialysis segment, including all imaging and radiological supervision and interpretation necessary to perform the angioplasty. 36906 ...... Percutaneous transluminal mechanical thrombectomy and/ NEW 9.88 9.88 No. or infusion for thrombolysis, dialysis circuit, any method, including all imaging and radiological supervision and interpretation, diagnostic angiography, fluoroscopic guidance, catheter placement(s), and intraprocedural pharmacological thrombolytic injection(s); with transcatheter placement of an intravascular stent(s), peripheral dialysis segment, including all imaging and radiological supervision and interpretation to perform the stenting and all angioplasty within the peripheral dialysis circuit. 36907 ...... Transluminal balloon angioplasty, central dialysis seg- NEW 2.48 2.48 No. ment, performed through dialysis circuit, including all imaging and radiological supervision and interpretation required to perform the angioplasty. 36908 ...... Transcatheter placement of an intravascular stent(s), cen- NEW 3.73 3.73 No. tral dialysis segment, performed through dialysis circuit, including all imaging and radiological supervision and interpretation required to perform the stenting, and all angioplasty in the central dialysis segment. 36909 ...... Dialysis circuit permanent vascular embolization or occlu- NEW 3.48 3.48 No. sion (including main circuit or any accessory veins), endovascular, including all imaging and radiological supervision and interpretation necessary to complete the intervention. 37246 ...... Transluminal balloon angioplasty (except lower extremity NEW 7.00 7.00 No. artery(s) for occlusive disease, intracranial, coronary, pulmonary, or dialysis circuit), open or percutaneous, including all imaging and radiological supervision and interpretation necessary to perform the angioplasty within the same artery; initial artery. 37247 ...... Transluminal balloon angioplasty (except lower extremity NEW 3.50 3.50 No. artery(s) for occlusive disease, intracranial, coronary, pulmonary, or dialysis circuit), open or percutaneous, including all imaging and radiological supervision and interpretation necessary to perform the angioplasty within the same artery; each additional artery. 37248 ...... Transluminal balloon angioplasty (except dialysis circuit), NEW 6.00 6.00 No. open or percutaneous, including all imaging and radiological supervision and interpretation necessary to perform the angioplasty within the same vein; initial vein. 37249 ...... Transluminal balloon angioplasty (except dialysis circuit), NEW 2.97 2.97 No. open or percutaneous, including all imaging and radiological supervision and interpretation necessary to perform the angioplasty within the same vein; each additional vein. 41530 ...... Submucosal ablation of the tongue base, radiofrequency, 3.50 3.50 3.50 No. 1 or more sites, per session. 43210 ...... Esophagogastroduodenoscopy, flexible, transoral; with 7.75 7.75 7.75 No. esophagogastric fundoplasty, partial or complete, includes duodenoscopy when performed. 43284 ...... Laparoscopy, surgical, esophageal sphincter augmenta- NEW 9.03 10.13 No. tion procedure, placement of sphincter augmentation device (i.e., magnetic band), including cruroplasty when performed. 43285 ...... Removal of esophageal sphincter augmentation device .... NEW 9.37 10.47 No. 47531 ...... Injection procedure for cholangiography, percutaneous, 1.80 1.30 1.30 No. complete diagnostic procedure including imaging guidance (eg, ultrasound and/or fluoroscopy) and all associated radiological supervision and interpretation; existing access.

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TABLE 27—FINALIZED CY 2017 WORK RVUS FOR NEW, REVISED AND POTENTIALLY MISVALUED CODES—Continued

Proposed CY CMS Work HCPCS Code Long Descriptor CY 2016 2017 Work Final CY 2017 time Work RVU RVU Work RVU refinement

47532 ...... Injection procedure for cholangiography, percutaneous, 4.25 4.25 4.25 No. complete diagnostic procedure including imaging guidance (eg, ultrasound and/or fluoroscopy) and all associated radiological supervision and interpretation; new access (eg, percutaneous transhepatic cholangiogram). 47533 ...... Placement of biliary drainage catheter, percutaneous, in- 6.00 5.38 5.38 No. cluding diagnostic cholangiography when performed, imaging guidance (eg, ultrasound and/or fluoroscopy), and all associated radiological supervision and interpretation; external. 47534 ...... Placement of biliary drainage catheter, percutaneous, in- 8.03 7.60 7.60 No. cluding diagnostic cholangiography when performed, imaging guidance (eg, ultrasound and/or fluoroscopy), and all associated radiological supervision and interpretation; internal-external. 47535 ...... Conversion of external biliary drainage catheter to inter- 4.50 3.95 3.95 No. nal-external biliary drainage catheter, percutaneous, including diagnostic cholangiography when performed, imaging guidance (eg, fluoroscopy), and all associated radiological supervision and interpretation. 47536 ...... Exchange of biliary drainage catheter (eg, external, inter- 2.88 2.61 2.61 No. nal-external, or conversion of internal-external to external only), percutaneous, including diagnostic cholangiography when performed, imaging guidance (eg, fluoroscopy), and all associated radiological supervision and interpretation. 47537 ...... Removal of biliary drainage catheter, percutaneous, re- 1.83 1.84 1.84 No. quiring fluoroscopic guidance (eg, with concurrent indwelling biliary stents), including diagnostic cholangiography when performed, imaging guidance (eg, fluoroscopy), and all associated radiological supervision and interpretation. 47538 ...... Placement of stent(s) into a bile duct, percutaneous, in- 6.60 4.75 4.75 No. cluding diagnostic cholangiography, imaging guidance (eg, fluoroscopy and/or ultrasound), balloon dilation, catheter exchange(s) and catheter removal(s) when performed, and all associated radiological supervision and interpretation, each stent; existing access. 47539 ...... Placement of stent(s) into a bile duct, percutaneous, in- 9.00 8.75 8.75 No. cluding diagnostic cholangiography, imaging guidance (eg, fluoroscopy and/or ultrasound), balloon dilation, catheter exchange(s) and catheter removal(s) when performed, and all associated radiological supervision and interpretation, each stent; new access, without placement of separate biliary drainage catheter. 47540 ...... Placement of stent(s) into a bile duct, percutaneous, in- 10.75 9.03 9.03 No. cluding diagnostic cholangiography, imaging guidance (eg, fluoroscopy and/or ultrasound), balloon dilation, catheter exchange(s) and catheter removal(s) when performed, and all associated radiological supervision and interpretation, each stent; new access, with placement of separate biliary drainage catheter (eg, external or internal-external). 47541 ...... Placement of access through the biliary tree and into 5.61 5.38 6.75 No. small bowel to assist with an endoscopic biliary procedure (eg, rendezvous procedure), percutaneous, including diagnostic cholangiography when performed, imaging guidance (eg, ultrasound and/or fluoroscopy), and all associated radiological supervision and interpretation, new access. 47542 ...... Balloon dilation of biliary duct(s) or of ampulla 2.50 2.85 2.85 No. (sphincteroplasty), percutaneous, including imaging guidance (eg, fluoroscopy), and all associated radiological supervision and interpretation, each duct. 47543 ...... Endoluminal biopsy(ies) of biliary tree, percutaneous, any 3.07 3.00 3.00 No. method(s) (eg, brush, forceps, and/or needle), including imaging guidance (eg, fluoroscopy), and all associated radiological supervision and interpretation, single or multiple.

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TABLE 27—FINALIZED CY 2017 WORK RVUS FOR NEW, REVISED AND POTENTIALLY MISVALUED CODES—Continued

Proposed CY CMS Work HCPCS Code Long Descriptor CY 2016 2017 Work Final CY 2017 time Work RVU RVU Work RVU refinement

47544 ...... Removal of calculi/debris from biliary duct(s) and/or gall- 4.29 3.28 3.28 No. bladder, percutaneous, including destruction of calculi by any method (eg, mechanical, electrohydraulic, lithotripsy) when performed, imaging guidance (eg, fluoroscopy), and all associated radiological supervision and interpretation. 49185 ...... Sclerotherapy of a fluid collection (eg, lymphocele, cyst, or 2.35 2.35 2.35 No. seroma), percutaneous, including contrast injection(s), sclerosant injection(s), diagnostic study, imaging guidance (eg, ultrasound, fluoroscopy) and radiological supervision and interpretation when performed. 50606 ...... Endoluminal biopsy of ureter and/or renal pelvis, non- 3.16 3.16 3.16 No. endoscopic, including imaging guidance (eg, ultrasound and/or fluoroscopy) and all associated radiological supervision and interpretation. 50705 ...... Ureteral embolization or occlusion, including imaging guid- 4.03 4.03 4.03 No. ance (eg, ultrasound and/or fluoroscopy) and all associated radiological supervision and interpretation. 50706 ...... Balloon dilation, ureteral stricture, including imaging guid- 3.80 3.80 3.80 No. ance (eg, ultrasound and/or fluoroscopy) and all associated radiological supervision and interpretation. 51700 ...... Bladder irrigation, simple, lavage and/or instillation ...... 0.88 0.60 0.60 No. 51701 ...... Insertion of non-indwelling bladder catheter (eg, straight 0.50 0.50 0.50 No. catheterization for residual urine). 51702 ...... Insertion of temporary indwelling bladder catheter; simple 0.50 0.50 0.50 No. (eg, Foley). 51703 ...... Insertion of temporary indwelling bladder catheter; com- 1.47 1.47 1.47 No. plicated (eg, altered anatomy, fractured catheter/balloon). 51720 ...... Bladder instillation of anticarcinogenic agent (including re- 1.50 0.87 0.87 No. tention time). 51784 ...... Electromyography studies (EMG) of anal or urethral 1.53 0.75 0.75 No. sphincter, other than needle, any technique. 52000 ...... Cystourethroscopy (separate procedure) ...... 2.23 1.53 1.53 No. 55700 ...... Biopsy, prostate; needle or punch, single or multiple, any 2.58 2.06 2.50 No. approach. 55866 ...... Laparoscopy, surgical prostatectomy, retropubic radical, 21.36 21.36 26.80 No. including nerve sparing, includes robotic assistance, when performed. 58555 ...... Hysteroscopy, diagnostic (separate procedure) ...... 3.33 2.65 2.65 No. 58558 ...... Hysteroscopy, surgical; with sampling (biopsy) of endo- 4.74 4.17 4.17 No. metrium and/or polypectomy, with or without D & C. 58559 ...... Hysteroscopy, surgical; with lysis of intrauterine adhesions 6.16 5.20 5.20 No. (any method). 58560 ...... Hysteroscopy, surgical; with division or resection of intra- 6.99 5.75 5.75 No. uterine septum (any method). 58561 ...... Hysteroscopy, surgical; with removal of leiomyomata ...... 9.99 6.60 6.60 No. 58562 ...... Hysteroscopy, surgical; with removal of impacted foreign 5.20 4.00 4.00 No. body. 58563 ...... Hysteroscopy, surgical; with endometrial ablation (eg, 6.16 4.47 4.47 No. endometrial resection, electrosurgical ablation, thermoablation). 58674 ...... Laparoscopy, surgical, ablation of uterine fibroid(s) includ- NEW 14.08 14.08 No. ing intraoperative ultrasound guidance and monitoring, radiofrequency. 61640 ...... Balloon dilatation of intracranial vasospasm, N N N No. percutaneous; initial vessel. 61641 ...... Balloon dilatation of intracranial vasospasm, N N N No. percutaneous; each additional vessel in same vascular family. 61642 ...... Balloon dilatation of intracranial vasospasm, N N N No. percutaneous; each additional vessel in different vascular family. 61645 ...... Percutaneous arterial transluminal mechanical 15.00 15.00 15.00 No. thrombectomy and/or infusion for thrombolysis, intracranial, any method, including diagnostic angiography, fluoroscopic guidance, catheter placement, and intraprocedural pharmacological thrombolytic injection(s).

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TABLE 27—FINALIZED CY 2017 WORK RVUS FOR NEW, REVISED AND POTENTIALLY MISVALUED CODES—Continued

Proposed CY CMS Work HCPCS Code Long Descriptor CY 2016 2017 Work Final CY 2017 time Work RVU RVU Work RVU refinement

61650 ...... Endovascular intracranial prolonged administration of 10.00 10.00 10.00 No. pharmacologic agent(s) other than for thrombolysis, arterial, including catheter placement, diagnostic angiography, and imaging guidance; initial vascular territory. 61651 ...... Endovascular intracranial prolonged administration of 4.25 4.25 4.25 No. pharmacologic agent(s) other than for thrombolysis, arterial, including catheter placement, diagnostic angiography, and imaging guidance; each additional vascular territory. 62320 ...... Injection(s), of diagnostic or therapeutic substance(s) (eg, NEW 1.80 1.80 No. anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, including needle or catheter placement, interlaminar epidural or subarachnoid, cervical or thoracic; without imaging guidance. 62321 ...... Injection(s), of diagnostic or therapeutic substance(s) (eg, NEW 1.95 1.95 No. anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, including needle or catheter placement, interlaminar epidural or subarachnoid, cervical or thoracic; with imaging guidance (i.e., fluoroscopy or CT). 62322 ...... Injection(s), of diagnostic or therapeutic substance(s) (eg, NEW 1.55 1.55 No. anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, including needle or catheter placement, interlaminar epidural or subarachnoid, lumbar or sacral (caudal); without imaging guidance. 62323 ...... Injection(s), of diagnostic or therapeutic substance(s) (eg, NEW 1.80 1.80 No. anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, including needle or catheter placement, interlaminar epidural or subarachnoid, lumbar or sacral (caudal); with imaging guidance (i.e., fluoroscopy or CT). 62324 ...... Injection(s), including indwelling catheter placement, con- NEW 1.89 1.89 No. tinuous infusion or intermittent bolus, of diagnostic or therapeutic substance(s) (eg, anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, interlaminar epidural or subarachnoid, cervical or thoracic; without imaging guidance. 62325 ...... Injection(s), including indwelling catheter placement, con- NEW 2.20 2.20 No. tinuous infusion or intermittent bolus, of diagnostic or therapeutic substance(s) (eg, anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, interlaminar epidural or subarachnoid, cervical or thoracic; with imaging guidance (i.e., fluoroscopy or CT). 62326 ...... Injection(s), including indwelling catheter placement, con- NEW 1.78 1.78 No. tinuous infusion or intermittent bolus, of diagnostic or therapeutic substance(s) (eg, anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, interlaminar epidural or subarachnoid, lumbar or sacral (caudal); without imaging guidance. 62327 ...... Injection(s), including indwelling catheter placement, con- NEW 1.90 1.90 No. tinuous infusion or intermittent bolus, of diagnostic or therapeutic substance(s) (eg, anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, interlaminar epidural or subarachnoid, lumbar or sacral (caudal); with imaging guidance (i.e., fluoroscopy or CT). 62380 ...... Endoscopic decompression of spinal cord, nerve root(s), NEW 9.09 C No. including laminotomy, partial facetectomy, foraminotomy, discectomy and/or excision of herniated intervertebral disc; 1 interspace, lumbar. 64461 ...... Paravertebral block (PVB) (paraspinous block), thoracic; 1.75 1.75 1.75 No. single injection site (includes imaging guidance, when performed). 64462 ...... Paravertebral block (PVB) (paraspinous block), thoracic; 1.10 1.10 1.10 No. second and any additional injection site(s) (includes imaging guidance, when performed).

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TABLE 27—FINALIZED CY 2017 WORK RVUS FOR NEW, REVISED AND POTENTIALLY MISVALUED CODES—Continued

Proposed CY CMS Work HCPCS Code Long Descriptor CY 2016 2017 Work Final CY 2017 time Work RVU RVU Work RVU refinement

64463 ...... Paravertebral block (PVB) (paraspinous block), thoracic; 1.81 1.81 1.90 No. continuous infusion by catheter (includes imaging guidance, when performed). 64553 ...... Percutaneous implantation of neurostimulator electrode 2.36 2.36 2.36 No. array; cranial nerve. 64555 ...... Percutaneous implantation of neurostimulator electrode 2.32 2.32 2.32 No. array; peripheral nerve (excludes sacral nerve). 64566 ...... Posterior tibial neurostimulation, percutaneous needle 0.60 0.60 0.60 No. electrode, single treatment, includes programming. 65778 ...... Placement of amniotic membrane on the ocular surface; 1.00 1.00 1.00 No. without sutures. 65779 ...... Placement of amniotic membrane on the ocular surface; 2.50 2.50 2.50 No. single layer, sutured. 65780 ...... Ocular surface reconstruction; amniotic membrane trans- 7.81 7.81 7.81 No. plantation, multiple layers. 65855 ...... Trabeculoplasty by laser surgery ...... 2.66 3.00 3.00 No. 66170 ...... Fistulization of sclera for glaucoma; trabeculectomy ab 11.27 13.94 13.94 No. externo in absence of previous surgery. 66172 ...... Fistulization of sclera for glaucoma; trabeculectomy ab 12.57 14.84 14.84 No. externo with scarring from previous ocular surgery or trauma (includes injection of antifibrotic agents). 67101 ...... Repair of retinal detachment, 1 or more sessions; 8.80 3.50 3.50 No. cryotherapy or diathermy, including drainage of subretinal fluid, when performed. 67105 ...... Repair of retinal detachment, 1 or more sessions; 8.53 3.39 3.39 No. photocoagulation, including drainage of subretinal fluid, when performed. 67107 ...... Repair of retinal detachment; scleral buckling (such as la- 14.06 16.00 16.00 No. mellar scleral dissection, imbrication or encircling procedure), including, when performed, implant, cryotherapy, photocoagulation, and drainage of subretinal fluid. 67108 ...... Repair of retinal detachment; with vitrectomy, any method, 15.19 17.13 17.13 No. including, when performed, air or gas tamponade, focal endolaser photocoagulation, cryotherapy, drainage of subretinal fluid, scleral buckling, and/or removal of lens by same technique. 67110 ...... Repair of retinal detachment; by injection of air or other 8.31 10.25 10.25 No. gas (eg, pneumatic retinopexy). 67113 ...... Repair of complex retinal detachment (eg, proliferative 19.00 19.00 19.00 No. vitreoretinopathy, stage C–1 or greater, diabetic traction retinal detachment, retinopathy of prematurity, retinal tear of greater than 90 degrees), with vitrectomy and membrane peeling, including, when performed, air, gas, or silicone oil tamponade, cryotherapy, endolaser photocoagulation, drainage of subretinal fluid, scleral buckling, and/or removal of lens. 67227 ...... Destruction of extensive or progressive retinopathy (eg, di- 3.50 3.50 3.50 No. abetic retinopathy), cryotherapy, diathermy. 67228 ...... Treatment of extensive or progressive retinopathy (eg, di- 4.39 4.39 4.39 No. abetic retinopathy), photocoagulation. 70540 ...... Magnetic resonance (eg, proton) imaging, orbit, face, and/ 1.35 1.35 1.35 No. or neck; without contrast material(s). 70542 ...... Magnetic resonance (eg, proton) imaging, orbit, face, and/ 1.62 1.62 1.62 No. or neck; with contrast material(s). 70543 ...... Magnetic resonance (eg, proton) imaging, orbit, face, and/ 2.15 2.15 2.15 No. or neck; without contrast material(s), followed by contrast material(s) and further sequences. 72170 ...... Radiologic examination, pelvis; 1 or 2 views ...... 0.17 0.17 0.17 No. 73501 ...... Radiologic examination, hip, unilateral, with pelvis when 0.18 0.18 0.18 No. performed; 1 view. 73502 ...... Radiologic examination, hip, unilateral, with pelvis when 0.22 0.22 0.22 No. performed; 2–3 views. 73503 ...... Radiologic examination, hip, unilateral, with pelvis when 0.27 0.27 0.27 No. performed; minimum of 4 views. 73521 ...... Radiologic examination, hips, bilateral, with pelvis when 0.22 0.22 0.22 No. performed; 2 views. 73522 ...... Radiologic examination, hips, bilateral, with pelvis when 0.29 0.29 0.29 No. performed; 3–4 views. 73523 ...... Radiologic examination, hips, bilateral, with pelvis when 0.31 0.31 0.31 No. performed; minimum of 5 views.

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TABLE 27—FINALIZED CY 2017 WORK RVUS FOR NEW, REVISED AND POTENTIALLY MISVALUED CODES—Continued

Proposed CY CMS Work HCPCS Code Long Descriptor CY 2016 2017 Work Final CY 2017 time Work RVU RVU Work RVU refinement

73551 ...... Radiologic examination, femur; 1 view ...... 0.16 0.16 0.16 No. 73552 ...... Radiologic examination, femur; minimum 2 views ...... 0.18 0.18 0.18 No. 74712 ...... Magnetic resonance (eg, proton) imaging, fetal, including 3.00 3.00 3.00 No. placental and maternal pelvic imaging when performed; single or first gestation. 74713 ...... Magnetic resonance (eg, proton) imaging, fetal, including 1.78 1.85 1.85 No. placental and maternal pelvic imaging when performed; each additional gestation. 76706 ...... Ultrasound, abdominal aorta, real time with image docu- NEW 0.55 0.55 No. mentation, screening study for abdominal aortic aneurysm. 77001 ...... Fluoroscopic guidance for central venous access device 0.38 0.38 0.38 No. placement, replacement (catheter only or complete), or removal (includes fluoroscopic guidance for vascular access and catheter manipulation, any necessary contrast injections through access site or catheter with related venography radiologic supervision and interpretation, and radiographic documentation of final catheter position). 77002 ...... Fluoroscopic guidance for needle placement (eg, biopsy, 0.54 0.38 0.54 No. aspiration, injection, localization device). 77003 ...... Fluoroscopic guidance and localization of needle or cath- 0.60 0.38 0.60 No. eter tip for spine or paraspinous diagnostic or therapeutic injection procedures (epidural or subarachnoid). 77065/G0206 .. Diagnostic mammography, including computer-aided de- NEW 0.81 0.81 No. tection (CAD) when performed; unilateral. 77066/G0204 .. Diagnostic mammography, including computer-aided de- NEW 1.00 1.00 No. tection (CAD) when performed; bilateral. 77067/G0202 .. Screening mammography, bilateral (2-view study of each NEW 0.76 0.76 No. breast), including computer-aided detection (CAD) when performed. 77332 ...... Treatment devices, design and construction; simple (sim- 0.54 0.45 0.45 No. ple block, simple bolus). 77333 ...... Treatment devices, design and construction; intermediate 0.84 0.75 0.75 No. (multiple blocks, stents, bite blocks, special bolus). 77334 ...... Treatment devices, design and construction; complex (ir- 1.24 1.15 1.15 No. regular blocks, special shields, compensators, wedges, molds or casts). 77470 ...... Special treatment procedure (eg, total body irradiation, 2.09 2.03 2.03 No. hemibody radiation, per oral or endocavitary irradiation). 77778 ...... Interstitial radiation source application, complex, includes 8.00 8.00 8.78 No. supervision, handling, loading of radiation source, when performed. 77790 ...... Supervision, handling, loading of radiation source ...... 0.00 0.00 0.00 No. 78264 ...... Gastric emptying imaging study (eg, solid, liquid, or both) 0.74 0.79 0.79 No. 78265 ...... Gastric emptying imaging study (eg, solid, liquid, or both); 0.98 0.98 0.98 No. with small bowel transit. 78266 ...... Gastric emptying imaging study (eg, solid, liquid, or both); 1.08 1.08 1.08 No. with small bowel and colon transit, multiple days. 88104 ...... Cytopathology, fluids, washings or brushings, except cer- 0.56 0.56 0.56 No. vical or vaginal; smears with interpretation. 88106 ...... Cytopathology, fluids, washings or brushings, except cer- 0.37 0.37 0.37 No. vical or vaginal; simple filter method with interpretation. 88108 ...... Cytopathology, concentration technique, smears and inter- 0.44 0.44 0.44 No. pretation (eg, Saccomanno technique). 88112 ...... Cytopathology, selective cellular enhancement technique 0.56 0.56 0.56 No. with interpretation (eg, liquid based slide preparation method), except cervical or vaginal. 88160 ...... Cytopathology, smears, any other source; screening and 0.50 0.50 0.50 No. interpretation. 88161 ...... Cytopathology, smears, any other source; preparation, 0.50 0.50 0.50 No. screening and interpretation. 88162 ...... Cytopathology, smears, any other source; extended study 0.76 0.76 0.76 No. involving over 5 slides and/or multiple stains. 88184 ...... Flow cytometry, cell surface, cytoplasmic, or nuclear 0.00 0.00 0.00 No. marker, technical component only; first marker. 88185 ...... Flow cytometry, cell surface, cytoplasmic, or nuclear 0.00 0.00 0.00 No. marker, technical component only; each additional marker. 88187 ...... Flow cytometry, interpretation; 2 to 8 markers ...... 1.36 0.74 0.74 No.

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Proposed CY CMS Work HCPCS Code Long Descriptor CY 2016 2017 Work Final CY 2017 time Work RVU RVU Work RVU refinement

88188 ...... Flow cytometry, interpretation; 9 to 15 markers ...... 1.69 1.20 1.20 No. 88189 ...... Flow cytometry, interpretation; 16 or more markers ...... 2.23 1.70 1.70 No. 88321 ...... Consultation and report on referred slides prepared else- 1.63 1.63 1.63 No. where. 88323 ...... Consultation and report on referred material requiring 1.83 1.83 1.83 No. preparation of slides. 88325 ...... Consultation, comprehensive, with review of records and 2.50 2.85 2.85 No. specimens, with report on referred material. 88341 ...... Immunohistochemistry or immunocytochemistry, per speci- 0.53 0.56 0.56 No. men; each additional single antibody stain procedure (List separately in addition to code for primary procedure). 88342 ...... Immunohistochemistry or immunocytochemistry, per speci- 0.70 0.70 0.70 No. men; initial single antibody stain procedure. 88344 ...... Immunohistochemistry or immunocytochemistry, per speci- 0.77 0.77 0.77 No. men; each multiplex antibody stain procedure. 88350 ...... Immunofluorescence, per specimen; each additional single 0.56 0.59 0.59 No. antibody stain procedure. 88364 ...... In situ hybridization (eg, FISH), per specimen; each addi- 0.67 0.70 0.70 No. tional single probe stain procedure. 88369 ...... Morphometric analysis, in situ hybridization (quantitative or 0.67 0.70 0.70 No. semi-quantitative), manual, per specimen; each additional single probe stain procedure. 91110 ...... Gastrointestinal tract imaging, intraluminal (eg, capsule 3.64 2.49 2.49 No. endoscopy), esophagus through ileum, with interpretation and report. 91111 ...... Gastrointestinal tract imaging, intraluminal (eg, capsule 1.00 1.00 1.00 No. endoscopy), esophagus with interpretation and report. 91200 ...... Liver elastography, mechanically induced shear wave (eg, 0.27 0.27 0.27 No. vibration), without imaging, with interpretation and report. 92132 ...... Scanning computerized ophthalmic diagnostic imaging, 0.35 0.30 0.30 No. anterior segment, with interpretation and report, unilateral or bilateral. 92133 ...... Scanning computerized ophthalmic diagnostic imaging, 0.50 0.40 0.40 No. posterior segment, with interpretation and report, unilateral or bilateral; optic nerve. 92134 ...... Scanning computerized ophthalmic diagnostic imaging, 0.50 0.45 0.45 No. posterior segment, with interpretation and report, unilateral or bilateral; retina. 92235 ...... Fluorescein angiography (includes multiframe imaging) 0.81 0.75 0.75 No. with interpretation and report. 92240 ...... Indocyanine-green angiography (includes multiframe imag- 1.10 0.80 0.80 No. ing) with interpretation and report. 92250 ...... Fundus photography with interpretation and report ...... 0.44 0.40 0.40 No. 92242 ...... Fluorescein angiography and indocyanine-green NEW 0.95 0.95 No. angiography (includes multiframe imaging) performed at the same patient encounter with interpretation and report, unilateral or bilateral. 93050 ...... Arterial pressure waveform analysis for assessment of 0.17 0.17 0.17 No. central arterial pressures, includes obtaining waveform(s), digitization and application of nonlinear mathematical transformations to determine central arterial pressures and augmentation index, with interpretation and report, upper extremity artery, non-invasive. 93590 ...... Percutaneous transcatheter closure of paravalvular leak; NEW 18.23 21.70 No. initial occlusion device, mitral valve. 93591 ...... Percutaneous transcatheter closure of paravalvular leak; NEW 14.50 17.97 No. initial occlusion device, aortic valve. 93592 ...... Percutaneous transcatheter closure of paravalvular leak; NEW 6.81 8.00 No. each additional occlusion device (list separately in addition to code for primary service). 95144 ...... Professional services for the supervision of preparation 0.06 0.06 0.06 No. and provision of antigens for allergen immunotherapy, single dose vial(s) (specify number of vials). 95165 ...... Professional services for the supervision of preparation 0.06 0.06 0.06 No. and provision of antigens for allergen immunotherapy; single or multiple antigens (specify number of doses). 95812 ...... Electroencephalogram (EEG) extended monitoring; 41–60 1.08 1.08 1.08 No. minutes.

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TABLE 27—FINALIZED CY 2017 WORK RVUS FOR NEW, REVISED AND POTENTIALLY MISVALUED CODES—Continued

Proposed CY CMS Work HCPCS Code Long Descriptor CY 2016 2017 Work Final CY 2017 time Work RVU RVU Work RVU refinement

95813 ...... Electroencephalogram (EEG) extended monitoring; great- 1.73 1.63 1.63 No. er than 1 hour. 95957 ...... Digital analysis of electroencephalogram (EEG) (eg, for 1.98 1.98 1.98 No. epileptic spike analysis). 95971 ...... Electronic analysis of implanted neurostimulator pulse 0.78 0.78 0.78 No. generator system (eg, rate, pulse amplitude, pulse duration, configuration of wave form, battery status, electrode selectability, output modulation, cycling, imped- ance and patient compliance measurements); simple spinal cord, or peripheral (i.e., peripheral nerve, sacral nerve, neuromuscular) neurostimulator pulse generator/ transmitter, with intraoperative or subsequent programming. 95972 ...... Electronic analysis of implanted neurostimulator pulse 0.80 0.80 0.80 No. generator system (eg, rate, pulse amplitude, pulse duration, configuration of wave form, battery status, electrode selectability, output modulation, cycling, imped- ance and patient compliance measurements); complex spinal cord, or peripheral (i.e., peripheral nerve, sacral nerve, neuromuscular) (except cranial nerve) neurostimulator pulse generator/transmitter, with intraoperative or subsequent programming. 96160 ...... Administration of patient-focused health risk assessment NEW 0.00 0.00 No. instrument (eg, health hazard appraisal) with scoring and documentation, per standardized instrument. 96161 ...... Administration of caregiver-focused health risk assess- NEW I 0.00 No. ment instrument (eg, depression inventory) for the benefit of the patient, with scoring and documentation, per standardized instrument. 96931 ...... Reflectance confocal microscopy (RCM) for cellular and 0.00 0.75 0.80 No. sub-cellular imaging of skin; image acquisition and interpretation and report, first lesion. 96932 ...... Reflectance confocal microscopy (RCM) for cellular and 0.00 0.00 0.00 No. sub-cellular imaging of skin; image acquisition only, first lesion. 96933 ...... Reflectance confocal microscopy (RCM) for cellular and 0.00 0.75 0.80 No. sub-cellular imaging of skin; interpretation and report only, first lesion. 96934 ...... Reflectance confocal microscopy (RCM) for cellular and 0.00 0.71 0.76 No. sub-cellular imaging of skin; image acquisition and interpretation and report, each additional lesion. 96935 ...... Reflectance confocal microscopy (RCM) for cellular and 0.00 0.00 0.00 No. sub-cellular imaging of skin; image acquisition only, each additional lesion. 96936 ...... Reflectance confocal microscopy (RCM) for cellular and 0.00 0.71 0.76 No. sub-cellular imaging of skin; interpretation and report only, each additional lesion. 97161 ...... Physical therapy evaluation; low complexity ...... NEW 1.20 1.20 Yes. 97162 ...... Physical therapy evaluation; moderate complexity ...... NEW 1.20 1.20 No. 97163 ...... Physical therapy evaluation; high complexity ...... NEW 1.20 1.20 Yes. 97164 ...... Reevaluation of physical therapy established plan of care NEW 0.60 0.75 No. 97165 ...... Occupational therapy evaluation; low complexity ...... NEW 1.20 1.20 Yes. 97166 ...... Occupational therapy evaluation; moderate complexity ...... NEW 1.20 1.20 No. 97167 ...... Occupational therapy evaluation; high complexity ...... NEW 1.20 1.20 Yes. 97168 ...... Reevaluation of occupational therapy care/established NEW 0.60 0.75 No. plan of care. 99151 ...... Moderate sedation services provided by the same physi- NEW 0.50 0.50 No. cian or other qualified health care professional performing the diagnostic or therapeutic service that the sedation supports, requiring the presence of an independent trained observer to assist in the monitoring of the patient’s level of consciousness and physiological status; initial 15 minutes of intra-service time, patient younger than 5 years of age.

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TABLE 27—FINALIZED CY 2017 WORK RVUS FOR NEW, REVISED AND POTENTIALLY MISVALUED CODES—Continued

Proposed CY CMS Work HCPCS Code Long Descriptor CY 2016 2017 Work Final CY 2017 time Work RVU RVU Work RVU refinement

99152 ...... Moderate sedation services provided by the same physi- NEW 0.25 0.25 No. cian or other qualified health care professional performing the diagnostic or therapeutic service that the sedation supports, requiring the presence of an independent trained observer to assist in the monitoring of the patient’s level of consciousness and physiological status; initial 15 minutes of intra-service time, patient age 5 years or older. 99153 ...... Moderate sedation services provided by the same physi- NEW 0.00 0.00 No. cian or other qualified health care professional performing the diagnostic or therapeutic service that the sedation supports, requiring the presence of an independent trained observer to assist in the monitoring of the patient’s level of consciousness and physiological status; each additional 15 minutes of intra-service time. 99155 ...... Moderate sedation services provided by a physician or NEW 1.90 1.90 No. other qualified health care professional other than the physician or other qualified health care professional performing the diagnostic or therapeutic service that the sedation supports; initial 15 minutes of intra-service time, patient younger than 5 years of age. 99156 ...... Moderate sedation services provided by a physician or NEW 1.65 1.65 No. other qualified health care professional other than the physician or other qualified health care professional performing the diagnostic or therapeutic service that the sedation supports; initial 15 minutes of intra-service time, patient age 5 years or older. 99157 ...... Moderate sedation services provided by a physician or NEW 1.25 1.25 No. other qualified health care professional other than the physician or other qualified health care professional performing the diagnostic or therapeutic service that the sedation supports; each additional 15 minutes intraservice time. 99354 ...... Prolonged evaluation and management or psychotherapy 1.77 2.33 2.33 No. service(s) (beyond the typical service time of the primary procedure) in the office or other outpatient setting requiring direct patient contact beyond the usual service; first hour. 99358 ...... Prolonged evaluation and management service before 2.10 2.10 2.10 No. and/or after direct patient care; first hour. 99359 ...... Prolonged evaluation and management service before 1.00 1.00 1.00 No. and/or after direct patient care; each additional 30 minutes. 99487 ...... Complex chronic care management services, with the fol- 0.00 1.00 1.00 No. lowing required elements: multiple (two or more) chronic conditions expected to last at least 12 months, or until the death of the patient, chronic conditions place the patient at significant risk of death, acute exacerbation/ decompensation, or functional decline, establishment or substantial revision of a comprehensive care plan, moderate or high complexity medical decision making; 60 minutes of clinical staff time directed by a physician or other qualified health care professional, per calendar month; 99489 ...... Complex chronic care management services, with the fol- 0.00 0.50 0.50 No. lowing required elements: multiple (two or more) chronic conditions expected to last at least 12 months, or until the death of the patient, chronic conditions place the patient at significant risk of death, acute exacerbation/ decompensation, or functional decline, establishment or substantial revision of a comprehensive care plan, moderate or high complexity medical decision making; 60 minutes of clinical staff time directed by a physician or other qualified health care professional, per calendar month.; each additional 30 minutes of clinical staff time directed by a physician or other qualified health care professional, per calendar month. G0416 ...... Surgical pathology, gross and microscopic examinations, 3.09 3.60 3.60 No. for prostate needle biopsy, any method.

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TABLE 27—FINALIZED CY 2017 WORK RVUS FOR NEW, REVISED AND POTENTIALLY MISVALUED CODES—Continued

Proposed CY CMS Work HCPCS Code Long Descriptor CY 2016 2017 Work Final CY 2017 time Work RVU RVU Work RVU refinement

G0500 ...... Moderate sedation services provided by the same physi- NEW 0.10 0.10 No. cian or other qualified health care professional performing a gastrointestinal endoscopic service that sedation supports, requiring the presence of an independent trained observer to assist in the monitoring of the patient’s level of consciousness and physiological status; initial 15 minutes of intra-service time; patient age 5 years or older. (additional time may be reported with 99153, as appropriate). G0501 ...... Resource-intensive services for patients for whom the use NEW 0.48 B No. of specialized mobility-assistive technology (such as adjustable height chairs or tables, patient lift, and adjustable padded leg supports) is medically necessary and used during the provision of an office/outpatient, evaluation and management visit. (List separately in addition to primary service). G0502 ...... Initial psychiatric collaborative care management, first 70 NEW 1.59 1.70 No. minutes in the first calendar month of behavioral health care manager activities, in consultation with a psychiatric consultant, and directed by the treating physician or other qualified health care professional, with the following required elements:. • outreach to and engagement in treatment of a patient directed by the treating physician or other qualified health care professional; • initial assessment of the patient, including administration of validated rating scales, with the development of an individualized treatment plan;. • review by the psychiatric consultant with modifications of the plan if recommended; • entering patient in a registry and tracking patient follow- up and progress using the registry, with appropriate documentation, and participation in weekly caseload consultation with the psychiatric consultant; and. • provision of brief interventions using evidence-based techniques such as behavioral activation, motivational interviewing, and other focused treatment strategies. G0503 ...... Subsequent psychiatric collaborative care management, NEW 1.42 1.53 No. first 60 minutes in a subsequent month of behavioral health care manager activities, in consultation with a psychiatric consultant, and directed by the treating physician or other qualified health care professional, with the following required elements: • tracking patient follow-up and progress using the registry, with appropriate documentation; • participation in weekly caseload consultation with the psychiatric consultant; • ongoing collaboration with and coordination of the patient’s mental health care with the treating physician or other qualified health care professional and any other treating mental health providers; • additional review of progress and recommendations for changes in treatment, as indicated, including medications, based on recommendations provided by the psychiatric consultant; • provision of brief interventions using evidence-based techniques such as behavioral activation, motivational interviewing, and other focused treatment strategies;. • monitoring of patient outcomes using validated rating scales; and relapse prevention planning with patients as they achieve remission of symptoms and/or other treatment goals and are prepared for discharge from active treatment.

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TABLE 27—FINALIZED CY 2017 WORK RVUS FOR NEW, REVISED AND POTENTIALLY MISVALUED CODES—Continued

Proposed CY CMS Work HCPCS Code Long Descriptor CY 2016 2017 Work Final CY 2017 time Work RVU RVU Work RVU refinement

G0504 ...... Initial or subsequent psychiatric collaborative care man- NEW 0.71 0.82 No. agement, each additional 30 minutes in a calendar month of behavioral health care manager activities, in consultation with a psychiatric consultant, and directed by the treating physician or other qualified health care professional (List separately in addition to code for primary procedure). (Use GPPP3 in conjunction with GPPP1, GPPP2). G0505 ...... Cognition and functional assessment using standardized NEW 3.30 3.44 Yes. instruments with development of recorded care plan for the patient with cognitive impairment, history obtained from patient and/or caregiver, in office or other outpatient setting or home or domiciliary or rest home. G0506 ...... Comprehensive assessment of and care planning for pa- NEW 0.87 0.87 No. tients requiring chronic care management services. (List separately in addition to primary monthly care management service). G0507 ...... Care management services for behavioral health condi- NEW 0.61 0.61 No. tions, at least 20 minutes of clinical staff time, directed by a physician or other qualified health care professional, per calendar month, with the following required elements: • Initial assessment or follow-up monitoring, including the use of applicable validated rating scales; • Behavioral health care planning in relation to behavioral/ psychiatric health problems, including revision for patients who are not progressing or whose status changes; • Facilitating and coordinating treatment such as psychotherapy, pharmacotherapy, counseling and/or psychiatric consultation; and •Continuity of care with a designated member of the care team. G0508 ...... Telehealth consultation, critical care, initial, physicians NEW 4.00 4.00 No. typically spend 60 minutes communicating with the patient and providers via telehealth. G0509 ...... Telehealth consultation, critical care, subsequent, physi- NEW 3.86 3.86 No. cians typically spend 50 minutes communicating with the patient and providers via telehealth.

VerDate Sep<11>2014 16:32 Nov 12, 2016 Jkt 241001 PO 00000 Frm 00198 Fmt 4701 Sfmt 4700 E:\FR\FM\15NOR2.SGM 15NOR2 mstockstill on DSK3G9T082PROD with RULES2 Federal Register / Vol. 81, No. 220 / Tuesday, November 15, 2016 / Rules and Regulations 80367 0.02 0.00 3.00 3.00 8.76 8.76 13.97 13.97 ¥ 0.34 ¥ 0.18 ¥ 0.50 ¥ 0.35 ¥ 0.08 ¥ 0.01 ¥ 0.02 ¥ 0.02 ¥ 0.02 ¥ 9.99 costs ¥ 19.98 ¥ 13.32 ¥ 26.64 ¥ 62.98 ¥ 62.98 Direct change Comment form to changes in clinical labor time. form to changes in clinical labor time. not typical; see preamble text. not typical; see preamble text. not typical; see preamble text. not typical; see preamble text. not typical; see preamble text. not typical; see preamble text. form to established policies for surgical instrument packs. other item; see preamble text EQ170. form to established policies for scope accessories. form to established policies for scopes. form to established policies for surgical instrument packs. other item; see preamble text EQ170. form to established policies for scope accessories. form to established policies for scopes. form to established policies for surgical instrument packs. S9: Add-on code. Additional supplies 8 G1: See preamble text ...... 0.01 0 0 G1: See preamble text0 ...... G1: See preamble text0 ...... G1: See preamble text0 ...... G1: See preamble text ...... 0 S9: Add-on code. Additional supplies CMS

refinement (min or qty) ABLE

1 0 7 8 G1: See preamble text ...... 0.37 2 1 1 2 T 10 RUC (min or qty) or current value recommendation EFINEMENT .... 2 1 S9: Add-on code. Additional supplies ..... 1 0 S9: Add-on code. Additional supplies PE R ...... 7 ...... 7 8 E15: Refined equipment time to con- 1 8 E15: Refined equipment time to con- 0 S9: Add-on code. Additional supplies IRECT D Labor activity ULE (where applicable) forming procedure. R INAL NF ...... 0 NF 8 G1: See preamble text ...... 0.02 0.5 0 S9: Add-on code. Additional supplies F ...... F ...... 138 F F ...... 129 F E5: Refined equipment time to con- 0 ...... 198 F 0 108 E19: Refined equipment time to con- ...... 138 F 0 G1: See preamble textF ...... 189 ...... E4: Refined equipment time to con- ...... 129 F E5: Refined equipment time to con- 0 ...... 198 0 108 E19: Refined equipment time to con- 138 0 G1: See preamble text ...... 189 E4: Refined equipment time to con- 129 E5: Refined equipment time to con- 28—CY 2017 F ABLE T Input code description NF/F $1499). (Silvadene). $1499). essor, digital capture, monitor, printer, cart). tem. video, non-channeled. $1499). essor, digital capture, monitor, printer, cart). tem. video, non-channeled. $1499). code Input EQ137 ..... instrument pack, basic ($500– EQ167 .....xenon...... source, light F ES031 ...... video system, endoscopy (proc- ...... ES060 ...... Video-flexible laryngoscope sys- ES063 ...... rhinolaryngoscope, flexible, EQ137 ..... 0 instrument pack, basic ($500– EQ167 .....xenon...... source, light F 108 E13: Equipment item replaces an- ES031 ...... video system, endoscopy (proc- ...... ES060 ...... Video-flexible laryngoscope sys- ES063 ...... rhinolaryngoscope, flexible, EQ137 ..... 0 instrument pack, basic ($500– 108 E13: Equipment item replaces an- sten. sten. sten. sten. sten. sten. sten. sten. sten. sten. sten. HCPCS code description code HCPCS 11732 ....11732 Remove nail plate add-on .... Remove nail plate add-on EF015 ...... EF031 mayo stand ...... 11732 ...... table, power NF ...... Remove nail plate add-on 11732 NF EQ137 ...... Remove nail plate add-on instrument ...... pack, EQ168 basic .....11732 ($500– .... light, exam ...... Remove nail plate add-on 11732 NF L037D ...... Remove nail plate add-on RN/LPN/MTA11732 ...... SC031 ...... NF Remove nail plate add-on needle, 30g ...... 11732 SC051 ...... NF Assist physician in per- Remove nail plate add-on syringe 10–12ml11732 ...... SG067 ...... NF ...... Remove nail plate add-on penrose drain (0.25in x 4in)11732 ...... SH047 ...... NF Remove nail plate add-on lidocaine 1%–2% inj (Xylocaine)11732 SH064 ...... NF ...... Remove nail plate add-on silver 27197 SJ053 ...... 27197 sulfadiazene ...... Clsd tx pelvic ring fx ...... swab-pad, alcohol27198 ...... Clsd tx pelvic ring fx .... L037D ...... cream 27198 ...... NF Clsd tx pelvic ring fx .... L037D ...... RN/LPN/MTA31551 ...... Clsd tx pelvic ring fx .... L037D ...... RN/LPN/MTA ...... F ...... Laryngoplasty laryngeal L037D RN/LPN/MTA ...... F ...... 31551 RN/LPN/MTA F ...... 99212 27 minutes ...... F Laryngoplasty laryngeal 99213 36 minutes ...... 99212 27 minutes31551 ...... 99213 36 minutes ...... Laryngoplasty laryngeal 31551 .... Laryngoplasty laryngeal 31551 .... Laryngoplasty laryngeal 31552 .... Laryngoplasty laryngeal 31552 .... Laryngoplasty laryngeal 31552 .... Laryngoplasty laryngeal 31552 .... Laryngoplasty laryngeal 31552 .... Laryngoplasty laryngeal 31553 .... Laryngoplasty laryngeal

VerDate Sep<11>2014 22:03 Nov 11, 2016 Jkt 241001 PO 00000 Frm 00199 Fmt 4701 Sfmt 4700 E:\FR\FM\15NOR2.SGM 15NOR2 mstockstill on DSK3G9T082PROD with RULES2 80368 Federal Register / Vol. 81, No. 220 / Tuesday, November 15, 2016 / Rules and Regulations 4.92 3.39 0.92 4.27 0.92 4.27 1.05 3.00 3.00 3.13 8.76 8.76 13.97 13.97 ¥ 0.02 150.00 costs ¥ 14.89 ¥ 13.63 ¥ 62.98 ¥ 62.98 Direct change ¥ 850.00 Comment form to established policies for scope accessories. form to established policies for scopes. item; see preamble SF030. form to established policies for scope accessories. form to established policies for scope accessories. form to established policies for scopes. form to established policies for scope accessories. form to established policies for scope accessories. form to established policies for scope accessories. item; see preamble SF029. other item; see preamble text EQ170. form to established policies for scope accessories. form to established policies for scopes. form to established policies for surgical instrument packs. other item; see preamble text EQ170. form to established policies for scope accessories. form to established policies for scopes. 0 S7: Supply item replaced by another 1 S8: Supply item replaces another 38 E19: Refined equipment time to con- CMS refinement (min or qty) 0 0 1 —Continued ABLE T RUC (min or qty) or current value recommendation ..... 0 33 E19: Refined equipment time to con- ...... 0 33 E19: Refined equipment time to con- EFINEMENT PE R Labor activity (where applicable) IRECT D ULE R NF ...... NF NF ...... 0 59 0 38 E19: Refined equipment time to con- NF ...... 0 NF G1: See preamble text ...... 65 E4: Refined equipment time to con- NF ...... 0 NF 54 ...... 0 33 E19: Refined equipment time to con- 0 G1: See preamble text ...... 60 E4: Refined equipment time to con- 0 33 E19: Refined equipment time to con- F ...... F F ...... F 0 ...... 198 F 108 0 E19: Refined equipment time to con- ...... 138 F 0 G1: See preamble text ...... F 189 ...... E4: Refined equipment time to con- 129 ...... E5: Refined equipment time to con- 0 198 108 0 E19: Refined equipment time to con- 0 G1: See preamble text ...... 189 E4: Refined equipment time to con- INAL 28—CY 2017 F Input code description NF/F essor, digital capture, monitor, printer, cart). goscope system. video, channeled. essor, digital capture, monitor, printer, cart). goscope system. video, channeled. essor, digital capture, monitor, printer, cart). essor, digital capture, monitor, printer, cart). tem. video, non-channeled. $1499). essor, digital capture, monitor, printer, cart). tem. video, non-channeled. ABLE T code Input EQ167 .....xenon...... source, light F ES031 ...... video system, endoscopy (proc- ES060 ...... Video-flexible laryngoscope sys- ES063 ...... rhinolaryngoscope, flexible, EQ137 0 ..... instrument pack, basic ($500– EQ167 .....xenon...... source, light F 108 E13: Equipment item replaces an- ES031 ...... video system, endoscopy (proc- ES060 ...... Video-flexible laryngoscope sys- ES063 ...... rhinolaryngoscope, flexible, 0 108 E13: Equipment item replaces an- sten. sten. sten. sten. sten. sten. sten. sten. sten. HCPCS code description code HCPCS 31553 .... Laryngoplasty laryngeal 31553 .... Laryngoplasty laryngeal 31553 .... Laryngoplasty laryngeal 31553 .... Laryngoplasty laryngeal 31554 .... Laryngoplasty laryngeal 31554 .... Laryngoplasty laryngeal 31554 .... Laryngoplasty laryngeal 31554 .... Laryngoplasty laryngeal 31554 .... Laryngoplasty laryngeal 31572 .... Largsc w/laser dstrj les ..... EQ16731572 ...... light source, xenon ...... Largsc w/laser dstrj les ..... NF ES031 ...... 31572 .... video system, endoscopy ...... Largsc w/laser dstrj les (proc- .....31572 .... ES061 ...... Largsc w/laser dstrj les ..... Video-flexible channeled ES064 laryn- ...... 31572 .... rhinolaryngoscope, Largsc w/laser dstrj les .....31572 .... SF029 ...... flexible, Largsc w/laser dstrj les ..... laser tip, bare (single use)31573 ...... SF030 ...... NF Largsc w/ther injection ...... laser tip, diffuser fiber ...... EQ16731573 NF ...... light source, xenon ...... Largsc w/ther injection ...... NF ES031 ...... 31573 .... video system, endoscopy ...... Largsc w/ther injection (proc- ...... 31573 .... ES061 ...... Largsc w/ther injection ...... Video-flexible channeled ES064 laryn- ...... 31574 .... rhinolaryngoscope, Largsc w/njx augmentation EQ167 .....31574 flexible, light source, xenon ...... Largsc w/njx augmentation NF ES031 ...... video system, endoscopy ...... (proc-

VerDate Sep<11>2014 22:03 Nov 11, 2016 Jkt 241001 PO 00000 Frm 00200 Fmt 4701 Sfmt 4700 E:\FR\FM\15NOR2.SGM 15NOR2 mstockstill on DSK3G9T082PROD with RULES2 Federal Register / Vol. 81, No. 220 / Tuesday, November 15, 2016 / Rules and Regulations 80369 2.78 0.50 2.33 2.18 0.78 3.62 2.87 0.00 0.00 0.83 3.88 3.08 ¥ 0.02 ¥ 0.02 ¥ 0.02 ¥ 0.74 ¥ 0.03 ¥ 0.02 ¥ 0.03 ¥ 13.63 ¥ 19.09 ¥ 14.00 ¥ 13.88 form to established policies for scopes. form to changes in clinical labor time. form to established policies for scope accessories. form to changes in clinical labor time. form to changes in clinical labor time. form to established policies for scope accessories. form to established policies for scopes. form to established policies for scope accessories. form to established policies for scope accessories. form to established policies for scopes. form to changes in clinical labor time. form to changes in clinical labor time. form to changes in clinical labor time. form to established policies for scope accessories. form to changes in clinical labor time. form to changes in clinical labor time. form to established policies for scope accessories. form to established policies for scopes. 3 1 G1: See preamble text ...... 0 28 E19: Refined equipment time to con- ..... 0 18 E19: Refined equipment time to con- physician staff. NF NF ...... NF ...... 60 NF 0 ...... 23 NF 0 G1: See preamble text ...... 60 E4: Refined equipment time to con- NF ...... 21 E15: Refined equipment time to con- 23 NF NF ...... 23 ...... 21 E15: Refined equipment time to con- 0 21 E15: Refined equipment time to con- 44 NF 0 18 E19: Refined equipment time to con- ...... NF 0 NF ...... G1: See preamble text ...... 47 E4: Refined equipment time to con- ...... 0 55 0 28 E19: Refined equipment time to con- 0 G1: See preamble text ...... 55 E4: Refined equipment time to con- NF ...... NF ...... 99 NF ...... 96 E15: Refined equipment time to con- 40 NF ...... NF ...... 39 E15: Refined equipment time to con- 99 NF NF ...... 99 ...... 96 E15: Refined equipment time to con- 0 96 E15: Refined equipment time to con- 54 0 30 E19: Refined equipment time to con- 0 G1: See preamble text ...... 59 E4: Refined equipment time to con- tem. video, non-channeled. ing. source. ENT (SMR). essor, digital capture, monitor, printer, cart). tem. video, non-channeled. essor, digital capture, monitor, printer, cart). goscope system. video, channeled. ing. $1499). source. ENT (SMR). essor, digital capture, monitor, printer, cart). goscope system. video, channeled. EF008 ...... chair with headrest, exam, reclin- EF015 ...... stand mayo ...... NF EQ137 ..... instrument pack, basic ($500– ...... EQ167 .....xenonsource, light ...... NF EQ170 ..... light, fiberoptic headlight w- ...... 99 EQ234 ..... suction and pressure cabinet, ES031 ...... video system, endoscopy (proc- 96 E15: Refined equipment time to con- 0 ES061 ...... Video-flexible channeled laryn- ES064 ...... rhinolaryngoscope, flexible, 30 E19: Refined equipment time to con- ynx. ynx. ynx. ynx. ynx. ynx. ynx. ynx. ynx. 31574 .... Largsc w/njx augmentation 31574 ES060 ...... Video-flexible Largsc w/njx augmentation laryngoscope sys- ES063 ...... 31575 rhinolaryngoscope, ....laryngoscopy Diagnostic ... EF008 flexible, ...... 31575 .... chair with headrest, exam, reclin- Diagnostic laryngoscopy ... EQ16731575 ...... laryngoscopy... light source, xenon ...... Diagnostic EQ170 NF .....31575 light, fiberoptic headlight w- ....laryngoscopy...... Diagnostic EQ234 .....31575 suction and pressure cabinet, ....laryngoscopy Diagnostic ... ES031 ...... 31575 .... video system, endoscopy (proc- laryngoscopy... Diagnostic 31575 ES060 ...... Diagnostic laryngoscopy Video-flexible laryngoscope sys- ... ES063 ...... 31575 .... rhinolaryngoscope, Diagnostic laryngoscopy ...31576 .... L037D ...... flexible, Laryngoscopy with biopsy RN/LPN/MTA ...... EQ167 .....31576 NF .... light source, xenon ...... Laryngoscopy with biopsy Clean room/equipment by NF ES031 ...... 31576 .... video system, endoscopy ...... (proc- Laryngoscopy with biopsy 31576 ES061 ...... Laryngoscopy with biopsy Video-flexible channeled ES064 laryn- ...... 31577 .... rhinolaryngoscope, Remove foreign body lar- 31577 flexible, .... Remove foreign body lar- 31577 .... Remove foreign body lar- 31577 .... Remove foreign body lar- 31577 .... Remove foreign body lar- 31577 .... Remove foreign body lar- 31577 .... Remove foreign body lar- 31577 .... Remove foreign body lar- 31577 .... Remove foreign body lar-

VerDate Sep<11>2014 22:03 Nov 11, 2016 Jkt 241001 PO 00000 Frm 00201 Fmt 4701 Sfmt 4700 E:\FR\FM\15NOR2.SGM 15NOR2 mstockstill on DSK3G9T082PROD with RULES2 80370 Federal Register / Vol. 81, No. 220 / Tuesday, November 15, 2016 / Rules and Regulations 0.92 4.27 3.13 0.00 0.69 3.23 2.50 3.00 13.97 ¥ 0.03 ¥ 0.02 ¥ 0.03 ¥ 0.33 ¥ 0.02 ¥ 0.37 ¥ 0.37 ¥ 0.74 ¥ 0.74 costs ¥ 62.98 ¥ 13.63 Direct change Comment form to established policies for scope accessories. form to established policies for scope accessories. form to established policies for scopes. form to changes in clinical labor time. form to changes in clinical labor time. form to established policies for scope accessories. form to changes in clinical labor time. form to changes in clinical labor time. form to established policies for scope accessories. form to established policies for scopes. form to established policies for scope accessories. form to established policies for surgical instrument packs. other item; see preamble text EQ170. form to established policies for scope accessories. with clinical labor task ‘‘Assist physician in performing the procedure’’ (L041B). with clinical labor task ‘‘Assist physician in performing the procedure’’ (L041B). 17: Clinical labor task redundant 2 L CMS refinement (min or qty) 3 1 G1: See preamble text ...... 3 3 1 G1: See preamble text ...... —Continued ABLE T RUC (min or qty) or current value recommendation .... 49 44 E19: Refined equipment time to con- ..... 0 33 E19: Refined equipment time to con- ..... 0 25 E19: Refined equipment time to con- ...... 31 28 E15: Refined equipment time to con- ...... 0 108 E13: Equipment item replaces an- EFINEMENT PE R Labor activity (where applicable) IRECT physician staff. physician staff. D ULE R NF ...... NF NF ...... NF 0 ...... 54 0 33 E19: Refined equipment time to con- 31 NF 0 G1: See preamble text ...... 60 E4: Refined equipment time to con- NF ...... 28 E15: Refined equipment time to con- NF ...... 31 NF ...... 31 28 E15: Refined equipment time to con- 0 28 E15: Refined equipment time to con- 0 25 F E19: Refined equipment time to con- 54 ...... E4: Refined equipment time to con- F ...... 138 F ...... 129 E5: Refined equipment time to con- 0 198 108 E19: Refined equipment time to con- 0 G1: See preamble text ...... INAL 28—CY 2017 F Input code description NF/F essor, digital capture, monitor, printer, cart). goscope system. video, channeled. ing. source. ENT (SMR). essor, digital capture, monitor, printer, cart). video, non-channeled. $1499). essor, digital capture, monitor, printer, cart). tem. ABLE T code Input L037D ...... RN/LPN/MTA ...... L037D ...... NF RN/LPN/MTA ...... Clean room/equipment by NF Obtain vital signs ...... 3 2 L17: Clinical labor task redundant ynx. ynx. HCPCS code description code HCPCS 31577 .... Remove foreign body lar- 31577 .... Remove foreign body lar- 31578 .... Removal of larynx lesion .. EQ16731578 ...... light source, xenon Removal of larynx lesion ...... NF ES03131578 ...... video system, Removal of larynx lesion endoscopy ...... (proc- ..31578 .... ES061 ...... Removal of larynx lesion .. Video-flexible channeled ES06431579 ...... laryn- .... rhinolaryngoscope, laryngoscopy Diagnostic ... EF008 ...... 31579 flexible, .... chair with headrest, exam, reclin- Diagnostic laryngoscopy ... EF01531579 ...... mayo stand ...... Diagnostic laryngoscopy ... NF EQ16731579 ...... laryngoscopy... light source, xenon ...... Diagnostic ...... EQ170 ..... NF 31579 light, fiberoptic headlight w- ....laryngoscopy... Diagnostic ...... EQ234 .....31579 suction and pressure cabinet, ....laryngoscopy Diagnostic ... ES031 ...... 31579 .... video system, endoscopy (proc- Diagnostic laryngoscopy ... ES063 ...... 31579 .... rhinolaryngoscope, Diagnostic laryngoscopy ... ES065 ...... 31579 flexible, .... stroboscopy system ...... Diagnostic laryngoscopy ...31579 NF .... L037D ...... Diagnostic laryngoscopy ... RN/LPN/MTA ...... L037D ...... NF RN/LPN/MTA31580 ...... NF Clean room/equipment by Revision of larynx ...... EQ13731580 Obtain vital signs ...... instrument Revision of larynx pack, ...... basic ($500– EQ16731580 ...... light source, xenon Revision of larynx ...... F ES03131580 ...... video system, Revision of larynx endoscopy (proc- ...... ES060 ...... Video-flexible laryngoscope sys-

VerDate Sep<11>2014 22:03 Nov 11, 2016 Jkt 241001 PO 00000 Frm 00202 Fmt 4701 Sfmt 4700 E:\FR\FM\15NOR2.SGM 15NOR2 mstockstill on DSK3G9T082PROD with RULES2 Federal Register / Vol. 81, No. 220 / Tuesday, November 15, 2016 / Rules and Regulations 80371 8.76 3.00 8.76 3.00 8.76 8.76 8.76 3.00 0.48 0.78 3.00 13.97 13.97 13.97 13.97 ¥ 0.02 ¥ 0.02 ¥ 0.02 ¥ 0.02 ¥ 62.98 ¥ 62.98 ¥ 62.98 ¥ 62.98 form to established policies for scopes. form to established policies for surgical instrument packs. other item; see preamble text EQ170. form to established policies for scope accessories. form to established policies for scopes. form to established policies for surgical instrument packs. other item; see preamble text EQ170. form to established policies for scope accessories. form to established policies for scopes. form to established policies for surgical instrument packs. form to established policies for scope accessories. form to established policies for scopes. form to established policies for surgical instrument packs. other item; see preamble text EQ170. form to established policies for scope accessories. form to established policies for scopes. other item; see preamble text EQ170. other item; see preamble text EL015. other item; see preamble text EL015. 108 E13: Equipment item replaces an- 0 ...... 0 108 E13: Equipment item replaces an- ...... 0 108 E13: Equipment item replaces an- F ...... F ...... F 0 ...... 138 F F 189 ...... E4: Refined equipment time to con- ...... 129 F E5: Refined equipment time to con- 0 ...... 198 F 0 108 E19: Refined equipment time to con- ...... 138 F 0 G1: See preamble textF ...... 189 ...... E4: Refined equipment time to con- ...... 129 E5: Refined equipment time to con- 0 198 0 108 E19: Refined equipment time to con- 0 G1: See preamble text ...... 189 E4: Refined equipment time to con- F ...... F ...... 138 F F ...... 129 E5: Refined equipment time to con- 0 198 0 108 E19: Refined equipment time to con- 0 G1: See preamble text ...... 189 E4: Refined equipment time to con- F ...... F ...... 138 F F ...... 129 E5: Refined equipment time to con- 0 198 0 108 E19: Refined equipment time to con- 0 G1: See preamble text ...... 189 E4: Refined equipment time to con- video, non-channeled. $1499). essor, digital capture, monitor, printer, cart). tem. video, non-channeled. $1499). essor, digital capture, monitor, printer, cart). tem. video, non-channeled. $1499). essor, digital capture, monitor, printer, cart). tem. video, non-channeled. $1499). essor, digital capture, monitor, printer, cart). tem. video, non-channeled. EQ137 ..... instrument pack, basic ($500– EQ167 .....xenon...... source, light F ES031 ...... video system, endoscopy (proc- ...... ES060 ...... Video-flexible laryngoscope sys- ES063 ...... rhinolaryngoscope, flexible, 0 108 E13: Equipment item replaces an- EF014 ...... surgical light, ...... NF EF031 ...... power...... table, NF ...... 0 0 48 E13: Equipment item replaces an- 48 E13: Equipment item replaces an- medialization. medialization. medialization. medialization. medialization. 1st vein. 1st vein. 31580 .... Revision of larynx ...... ES06331584 ...... rhinolaryngoscope, Treat larynx fracture ...... EQ13731584 ..... flexible, .... instrument Treat larynx fracture pack, ...... basic ($500– EQ16731584 ...... light source, xenon Treat larynx fracture ...... F ES03131584 ...... video system, Treat larynx fracture endoscopy (proc- ...... 31584 ...... ES060 ...... Treat larynx fracture ...... Video-flexible laryngoscope sys- ES06331587 ...... rhinolaryngoscope, Revision of larynx ...... EQ13731587 ...... flexible, instrument Revision of larynx pack, ...... basic ($500– EQ16731587 ...... light source, xenon Revision of larynx ...... F ES03131587 ...... video system, Revision of larynx endoscopy (proc- ...... 31587 ...... ES060 ...... Revision of larynx ...... Video-flexible laryngoscope sys- ES06331591 ...... rhinolaryngoscope, Laryngoplasty 31591 .... flexible, Laryngoplasty 31591 .... Laryngoplasty 31591 .... Laryngoplasty 31591 .... Laryngoplasty 31592 ....resection..... Cricotracheal EQ137 .....31592 .... instrument pack, basic ($500– Cricotracheal resection ..... EQ16731592 ...... light source, xenonresection Cricotracheal ...... F ES031 ...... 31592 .... video system, endoscopy (proc- resection Cricotracheal .....31592 ...... ES060 ...... Cricotracheal resection Video-flexible laryngoscope sys- ..... ES06336473 ...... rhinolaryngoscope, Endovenous mchnchem 36473 flexible, .... Endovenous mchnchem

VerDate Sep<11>2014 22:03 Nov 11, 2016 Jkt 241001 PO 00000 Frm 00203 Fmt 4701 Sfmt 4700 E:\FR\FM\15NOR2.SGM 15NOR2 mstockstill on DSK3G9T082PROD with RULES2 80372 Federal Register / Vol. 81, No. 220 / Tuesday, November 15, 2016 / Rules and Regulations 5.58 0.30 0.49 3.49 ¥ 0.48 ¥ 0.54 ¥ 1.08 ¥ 0.74 ¥ 0.74 ¥ 1.08 ¥ 1.08 ¥ 1.08 ¥ 0.04 costs ¥ 23.00 ¥ 42.05 ¥ 10.51 ¥ 54.67 Direct change ¥ 110.20 ¥ 110.20 Comment form to changes in clinical labor time. item; see preamble SJ088. form to changes in clinical labor time. other item; see preamble text EQ250. other item; see preamble text EL015. service. typical for the procedure. other item; see preamble text EL015. other item; see preamble text EL015. other item; see preamble text EQ250. other item; see preamble text EL015. typical for the procedure. CMS refinement (min or qty) 1 0 G1: See preamble text ...... 2 0 G1: See preamble text ...... 5 3 G1: See preamble text ...... 2 2 0 G1: See preamble text ...... 0 G1: See preamble text ...... 2 0 2 G1: See preamble text ...... 0 G1: See preamble text ...... —Continued ABLE T RUC (min or qty) or current value recommendation ... 54 52 E15: Refined equipment time to con- ..... 60 0 S7: Supply item replaced by another ...... 37 35 E15: Refined equipment time to con- EFINEMENT PE R Labor activity (where applicable) IRECT supplies. confirmed. into U/S machine. Exam completed in RIS system to generate billing process and to populate images into Radiologist work queue. and questionnaire reviewed by technologist, order from physician confirmed and exam protocoled by radiologist. interpreting MD. in PACS, checking all images, reformats, and dose page. monitor pt/set up IV. D ULE R NF ...... 1 0 S3: Supply not typically used in this INAL 28—CY 2017 F Input code description NF/F Stick). ABLE T code Input EL015 ...... generalultrasound, room, ...... NF EQ250 .....portable...... unit, ultrasound ...... NF L037D ...... RN/LPN/MTA ...... L054A ...... NF Vascular Technologist ...... L054A Prepare room, equipment, ...... NF 39 Vascular Technologist ...... Availability of prior images NF 0 Exam documents scanned L054A 0 ...... E12: Equipment item replaced by an- Vascular Technologist 48 ...... E13: Equipment item replaces an- NF Patient clinical information L054A ...... Vascular Technologist ...... L054A ...... NF Vascular Technologist ...... Review examination with NF SA016 ...... Technologist QCs images kit, guidewire introducer (Micro- SH108 ...... AgentSclerosing Sotradecol ...... EF014 NF ...... surgical light, ...... NF ...... EF031 ...... power...... table, NF EL015 ...... generalultrasound, room, ...... NF EQ250 ..... 2 portable...... unit, ultrasound ...... NF 0 SH108 ...... AgentSclerosing Sotradecol ...... 0 NF 1 S6: Refined supply quantity to what is 30 E13: Equipment item replaces an- ...... 30 30 E13: Equipment item replaces an- 0 0 2 E12: Equipment item replaced by an- 30 E13: Equipment item replaces an- 1 S6: Refined supply quantity to what is 1st vein. 1st vein. 1st vein. 1st vein. 1st vein. 1st vein. 1st vein. 1st vein. 1st vein. 1st vein. add-on. add-on. add-on. add-on. add-on. HCPCS code description code HCPCS 36473 .... Endovenous mchnchem 36473 .... Endovenous mchnchem 36473 .... Endovenous mchnchem 36473 .... Endovenous mchnchem 36473 .... Endovenous mchnchem 36473 .... Endovenous mchnchem 36473 .... Endovenous mchnchem 36473 .... Endovenous mchnchem 36473 .... Endovenous mchnchem 36473 .... Endovenous mchnchem 36474 .... Endovenous mchnchem 36474 .... Endovenous mchnchem 36474 .... Endovenous mchnchem 36474 .... Endovenous mchnchem 36474 .... Endovenous mchnchem 36901 .... Intro cath dialysis circuit ... ED050 ...... 36901 .... PACS Workstation Proxy ...... Intro cath dialysis circuit ... NF EL01136901 ...... room, angiography ...... Intro cath dialysis circuit ...... 36901 NF .... L037D ...... Intro cath dialysis circuit ... RN/LPN/MTA ...... SJ041 ...... NF povidone soln (Betadine) ...... Prepare and position pt/ NF ......

VerDate Sep<11>2014 22:03 Nov 11, 2016 Jkt 241001 PO 00000 Frm 00204 Fmt 4701 Sfmt 4700 E:\FR\FM\15NOR2.SGM 15NOR2 mstockstill on DSK3G9T082PROD with RULES2 Federal Register / Vol. 81, No. 220 / Tuesday, November 15, 2016 / Rules and Regulations 80373 3.62 3.62 3.62 3.62 ¥ 0.48 ¥ 0.48 ¥ 0.04 ¥ 0.48 ¥ 0.04 ¥ 0.74 ¥ 0.74 ¥ 1.11 ¥ 1.11 ¥ 2.22 ¥ 1.11 ¥ 1.11 ¥ 1.11 ¥ 0.74 ¥ 0.04 ¥ 0.04 ¥ 10.51 ¥ 10.51 ¥ 10.51 ¥ 20.50 ¥ 101.75 item; see preamble SJ041. form to changes in clinical labor time. item; see preamble. item; see preamble. form to changes in clinical labor time. item; see preamble. item; see preamble. form to changes in clinical labor time. form to changes in clinical labor time. dancy when used together with supply SA015. item; see preamble. item; see preamble. form to changes in clinical labor time. form to changes in clinical labor time. form to changes in clinical labor time. dancy when used together with supply SA015. form with identical labor activity in other codes in the family. form with identical labor activity in other codes in the family. form with identical labor activity in other codes in the family. form with identical labor activity in other codes in the family. form with identical labor activity in other codes in the family. form with identical labor activity in other codes in the family. S2: Supply removed due to redun- 0 S7: Supply item replaced by another 0 5 3 G1: See preamble text ...... 5 3 G1: See preamble text ...... 6 0 6 L3: Refined clinical labor time to con- 3 5 L3: Refined clinical labor time to con- 3 G1: See preamble text ...... 1 3 6 0 L3: Refined clinical labor time to con- 3 6 L3: Refined clinical labor time to con- 3 6 L3: Refined clinical labor time to con- 3 L3: Refined clinical labor time to con- 60 . 89 87 E15: Refined equipment time to con- . 104 102 E15: Refined equipment time to con- ... 69 ... 67 E15: Refined equipment time to con- 79 77 E15: Refined equipment time to con- ..... 60 ..... 0 S7: Supply item replaced by another 60 0 S7: Supply item replaced by another ...... 72 70 E15: Refined equipment time to con- ...... 52 ...... 50 E15: Refined equipment time to con- 62 60 E15: Refined equipment time to con- ...... 2 1 S2: Supply removed due to redun- monitor pt/set up IV. monitor pt/set up IV. agnostic and referral forms. services. prescriptions. equipment in facility. services. prescriptions. monitor pt/set up IV. NF ...... 0 NF ...... 2 S8: Supply item replaces another 0 NF ...... 2 S8: Supply item replaces another 0 2 S8: Supply item replaces another NF ...... 0 2 S8: Supply item replaces another (chloraprep). (chloraprep). (chloraprep). (chloraprep). 36901 .... Intro cath dialysis circuit...dialysis 36901 SJ088 ....cath ...... Intro swab, patient prep, 3.0 ml 36902 .... Intro cath dialysis circuit ... ED050 ...... 36902 .... PACS Workstation Proxy ...... Intro cath dialysis circuit ... NF EL01136902 ...... room, angiography ...... Intro cath dialysis circuit ...... 36902 NF .... L037D ...... circuit... Intro cath dialysis circuit ...dialysis RN/LPN/MTA36902 ...... SJ088 ...... cath SJ041 ...... NF Intro swab, patient prep, 3.0 ml 36903 povidone soln (Betadine) ...... Prepare and position pt/ Intro cath dialysis circuit NF ... ED05036903 ...... PACS Workstation Proxy ...... Intro cath dialysis circuit ... NF EL01136903 ...... room, angiography ...... Intro cath dialysis circuit ...... 36903 NF .... L037D ...... circuit... Intro cath dialysis circuit ...dialysis 36903 RN/LPN/MTA ...... SJ088 ...... cath SJ041 ...... NF Intro swab, patient prep, 3.0 ml 36904 povidone soln (Betadine) ...... Prepare and position pt/ Thrmbc/nfs dialysis circuit NF ED050 ...... 36904 ...... PACS Workstation Proxy ...... Thrmbc/nfs dialysis circuit NF EL011 ...... 36904 .... room, angiography ...... Thrmbc/nfs dialysis circuit NF L037D ...... 36904 .... RN/LPN/MTA ...... Thrmbc/nfs dialysis circuit F L037D ...... 36904 .... RN/LPN/MTA ...... Thrmbc/nfs dialysis circuit Complete pre-service di- F L037D ...... 36904 .... RN/LPN/MTA ...... Thrmbc/nfs dialysis circuit Coordinate pre-surgery F L037D ...... 36904 .... RN/LPN/MTA ...... Thrmbc/nfs dialysis circuit Follow-up phone calls and F L037D ...... 36904 .... RN/LPN/MTA ...... Thrmbc/nfs dialysis circuit Schedule space and NF L037D ...... 36904 .... RN/LPN/MTA Coordinate pre-surgery ...... Thrmbc/nfs dialysis circuit 36904 NF L037D ...... Thrmbc/nfs dialysis circuit RN/LPN/MTA Follow-up phone calls and ...... SD032 ...... 36904 NF .... catheter, thrombectomy-Fogarty Thrmbc/nfs dialysis circuit Prepare and position pt/ NF SD136 ...... 36904 .... vascular sheath ...... Thrmbc/nfs dialysis circuit circuit 36904 NF SJ088 SJ041 ....dialysis ...... Thrmbc/nfs swab, patient prep, 3.0 ml povidone soln (Betadine)36905 ...... NF Thrmbc/nfs dialysis circuit ED050 ...... PACS Workstation Proxy ...... NF ......

VerDate Sep<11>2014 22:03 Nov 11, 2016 Jkt 241001 PO 00000 Frm 00205 Fmt 4701 Sfmt 4700 E:\FR\FM\15NOR2.SGM 15NOR2 mstockstill on DSK3G9T082PROD with RULES2 80374 Federal Register / Vol. 81, No. 220 / Tuesday, November 15, 2016 / Rules and Regulations 3.62 ¥ 0.48 ¥ 0.04 ¥ 1.11 ¥ 1.11 ¥ 2.22 ¥ 1.11 ¥ 1.11 ¥ 1.11 ¥ 0.74 ¥ 1.11 ¥ 1.11 ¥ 2.22 ¥ 1.11 ¥ 1.11 ¥ 1.11 costs ¥ 10.51 ¥ 20.50 ¥ 10.51 Direct change ¥ 101.75 Comment form to changes in clinical labor time. dancy when used together with supply SA015. item; see preamble. item; see preamble. form to changes in clinical labor time. form to changes in clinical labor time. dancy when used together with supply SA015. form with identical labor activity in other codes in the family. form with identical labor activity in other codes in the family. form with identical labor activity in other codes in the family. form with identical labor activity in other codes in the family. form with identical labor activity in other codes in the family. form with identical labor activity in other codes in the family. form with identical labor activity in other codes in the family. form with identical labor activity in other codes in the family. form with identical labor activity in other codes in the family. form with identical labor activity in other codes in the family. form with identical labor activity in other codes in the family. form with identical labor activity in other codes in the family. S2: Supply removed due to redun- 0 S7: Supply item replaced by another 0 CMS refinement (min or qty) 6 0 6 L3: Refined clinical labor time to con- 3 5 L3: Refined clinical labor time to con- 3 G1: See preamble text ...... 6 0 6 L3: Refined clinical labor time to con- 3 L3: Refined clinical labor time to con- 1 3 6 0 L3: Refined clinical labor time to con- 3 6 L3: Refined clinical labor time to con- 3 6 L3: Refined clinical labor time to con- 3 L3: Refined clinical labor time to con- 3 6 0 L3: Refined clinical labor time to con- 3 6 L3: Refined clinical labor time to con- 3 6 L3: Refined clinical labor time to con- 3 L3: Refined clinical labor time to con- —Continued 60 ABLE T RUC (min or qty) or current value recommendation . 119 117 E15: Refined equipment time to con- ...... 87 85 E15: Refined equipment time to con- ...... 102 100 E15: Refined equipment time to con- ...... 2 1 S2: Supply removed due to redun- EFINEMENT PE R Labor activity (where applicable) IRECT agnostic and referral forms. services. prescriptions. equipment in facility. services. prescriptions. monitor pt/set up IV. agnostic and referral forms. services. prescriptions. equipment in facility. services. prescriptions. D ULE R NF ...... 0 2 S8: Supply item replaces another INAL 28—CY 2017 F Input code description NF/F (chloraprep). ABLE T code Input HCPCS code description code HCPCS 36905 .... Thrmbc/nfs dialysis circuit EL011 ...... 36905 .... room, angiography ...... Thrmbc/nfs dialysis circuit NF L037D ...... 36905 .... RN/LPN/MTA ...... Thrmbc/nfs dialysis circuit F L037D ...... 36905 .... RN/LPN/MTA ...... Thrmbc/nfs dialysis circuit Complete pre-service di- F L037D ...... 36905 .... RN/LPN/MTA ...... Thrmbc/nfs dialysis circuit Coordinate pre-surgery F L037D ...... 36905 .... RN/LPN/MTA ...... Thrmbc/nfs dialysis circuit Follow-up phone calls and F L037D ...... 36905 .... RN/LPN/MTA ...... Thrmbc/nfs dialysis circuit Schedule space and NF L037D ...... 36905 .... RN/LPN/MTA Coordinate pre-surgery ...... Thrmbc/nfs dialysis circuit NF 36905 L037D ...... Thrmbc/nfs dialysis circuit RN/LPN/MTA Follow-up phone calls and ...... SD032 ...... NF 36905 .... catheter, thrombectomy-Fogarty Thrmbc/nfs dialysis circuit Prepare and position pt/ NF SD136 ...... 36905 .... vascular sheath ...... Thrmbc/nfs dialysis circuit circuit NF 36905SJ088 SJ041 ....dialysis ...... Thrmbc/nfs swab, patient prep, 3.0 ml povidone soln (Betadine) ...... 36906 ...... NF Thrmbc/nfs dialysis circuit ED050 ...... 36906 ...... PACS Workstation Proxy ...... Thrmbc/nfs dialysis circuit NF EL011 ...... 36906 .... room, angiography ...... Thrmbc/nfs dialysis circuit NF L037D ...... 36906 .... RN/LPN/MTA ...... Thrmbc/nfs dialysis circuit F L037D ...... 36906 .... RN/LPN/MTA ...... Thrmbc/nfs dialysis circuit Complete pre-service di- F L037D ...... 36906 .... RN/LPN/MTA ...... Thrmbc/nfs dialysis circuit Coordinate pre-surgery F L037D ...... 36906 .... RN/LPN/MTA ...... Thrmbc/nfs dialysis circuit Follow-up phone calls and F L037D ...... 36906 .... RN/LPN/MTA ...... Thrmbc/nfs dialysis circuit Schedule space and NF L037D ...... RN/LPN/MTA Coordinate pre-surgery ...... NF Follow-up phone calls and

VerDate Sep<11>2014 22:03 Nov 11, 2016 Jkt 241001 PO 00000 Frm 00206 Fmt 4701 Sfmt 4700 E:\FR\FM\15NOR2.SGM 15NOR2 mstockstill on DSK3G9T082PROD with RULES2 Federal Register / Vol. 81, No. 220 / Tuesday, November 15, 2016 / Rules and Regulations 80375 3.62 0.92 ¥ 0.48 ¥ 0.04 ¥ 5.55 ¥ 1.23 ¥ 0.74 ¥ 0.11 ¥ 0.03 ¥ 0.05 ¥ 1.02 ¥ 0.74 ¥ 0.74 ¥ 0.04 ¥ 0.03 ¥ 0.01 ¥ 0.07 ¥ 20.50 ¥ 10.51 ¥ 10.51 ¥ 15.76 ¥ 101.75 dancy when used together with supply SA015. item; see preamble. item; see preamble. form to changes in clinical labor time. dancy when used together with supply SA015. form to changes in clinical labor time. ated with moderate sedation; moderate sedation not typical for this procedure. clinical labor task. form to changes in clinical labor time. form to changes in clinical labor time. form to established policies for PACS Workstation Proxy. form to established policies for equipment with 4x monitoring time. form to established policies for equipment with 4x monitoring time. form to changes in clinical labor time. form to established policies for equipment with 4x monitoring time. form to established policies for equipment with 4x monitoring time. form to established policies for non- highly technical equipment. ated with moderate sedation; moderate sedation not typical for this procedure. form to established policies for PACS Workstation Proxy MS minutes backed out input. S2: Supply removed due to redun- 0 S7: Supply item replaced by another 0 6 3 L1: Refined time to standard for this 5 3 G1: See preamble text ...... 1 5 3 G1: See preamble text ...... 5 3 G1: See preamble text ...... 60 91 89 E15: Refined equipment time to con- 15 0 L11: Removed clinical labor associ- ..... 72 70 E15: Refined equipment time to con- ...... 2 1 S2: Supply removed due to redun- tient/monitor patient/set up IV. forming procedure. physician staff. monitor pt/set up IV. tient/monitor patient/set up IV. NF ...... 0 2 S8: Supply item replaces another NF ...... 87 82 E6: Refined equipment time to con- (chloraprep). NIBP, temp, resp). ED050 ...... ProxyWorkstation PACS ...... NF EL011 ...... angiography room, ...... NF L037D ...... RN/LPN/MTA ...... NF ED050 ...... ProxyWorkstation PACS ...... Prepare and position pa- 91 NF EF018 ...... stretcher ...... 72 NF EF027 ...... mobileinstrument, table, ...... 89 E15: Refined equipment time to con- NF EL011 ...... angiography room, ...... 70 51 E15: Refined equipment time to con- NF EQ011 ..... ECG, 3-channel (with SpO2, ...... 87 EQ032 ..... IV infusion pump 46 ...... 87 E18: Refined equipment time to con- NF EQ168 .....exam light, 82 ...... E6: Refined equipment time to con- 27 NF L037D ...... 82 RN/LPN/MTA ...... E6: Refined equipment time to con- NF L041B ...... Assist physician in per- 24 Radiologic Technologist E15: Refined equipment time to con- 87 ...... L051A ...... NF RN ...... 51 Clean room/equipment by NF ED050anesthesia ...... Sedate/Apply ..ProxyWorkstation PACS 82 ...... E6: Refined equipment NF ti me to con- 40 E1: Refined equipment time to con- ...... 2 34 0 L11: Removed clinical labor associ- 76 E18: Refined equipment time to con- vein. vein. vein. cholangiogram. cholangiogram. cholangiogram. cholangiogram. cholangiogram. cholangiogram. cholangiogram. cholangiogram. cholangiogram. cholangiogram. cholangiogram. 36906 .... Thrmbc/nfs dialysis circuit 36906 L037D ...... Thrmbc/nfs dialysis circuit RN/LPN/MTA ...... SD032 ...... 36906 NF .... catheter, thrombectomy-Fogarty Thrmbc/nfs dialysis circuit Prepare and position pt/ NF SD136 ...... 36906 .... vascular sheath ...... Thrmbc/nfs dialysis circuit circuit 36906 NF SJ088 SJ041 ....dialysis ...... Thrmbc/nfs swab, patient prep, 3.0 ml povidone soln (Betadine)37246 ...... NF Trluml balo angiop 1st art ED050 ...... 37246 ...... PACS Workstation Proxy ...... Trluml balo angiop 1st art NF EL011 ...... 37246 .... room, angiography ...... Trluml balo angiop 1st art NF L037D ...... 37248 .... RN/LPN/MTA ...... Trluml balo angiop 1st NF 37248 .... Prepare and position pa- Trluml balo angiop 1st 37248 .... Trluml balo angiop 1st 47531 .... Injection for 47531 .... Injection for 47531 .... Injection for 47531 .... Injection for 47531 .... Injection for 47531 .... Injection for 47531 .... Injection for 47531 .... Injection for 47531 .... Injection for 47531 .... Injection for 47532 .... Injection for

VerDate Sep<11>2014 22:03 Nov 11, 2016 Jkt 241001 PO 00000 Frm 00207 Fmt 4701 Sfmt 4700 E:\FR\FM\15NOR2.SGM 15NOR2 mstockstill on DSK3G9T082PROD with RULES2 80376 Federal Register / Vol. 81, No. 220 / Tuesday, November 15, 2016 / Rules and Regulations 1.26 0.22 0.00 5.93 4.18 0.00 0.16 ¥ 0.02 ¥ 0.04 ¥ 0.02 ¥ 1.23 ¥ 0.02 ¥ 0.04 ¥ 0.02 ¥ 7.65 ¥ 1.02 ¥ 1.23 ¥ 7.65 costs ¥ 15.76 ¥ 15.76 ¥ 22.95 ¥ 17.31 ¥ 30.60 Direct change y to con- Comment form to established policies for PACS Workstation Proxy MS minutes backed out input. backed out input. form to changes in clinical labor time MS minutes backed out input. backed out input. backed out input. form to established policies for non- highly technical equipment MS minutes backed out input. backed out input. form to established policies for non- highly technical equipment MS minutes backed out input. form to established policies for non- highly technical equipment MS minutes backed out input. clinical labor task. backed out input. backed out input. form to changes in clinical labor time MS minutes backed out input. backed out input. backed out input. form to established policies for non- highly technical equipment MS minutes backed out input. backed out input. backed out input. backed out input. backed out input. clinical labor task. backed out input. backed out input. 91 E18: Refined equipment time to con- 187 G1: See preamble text MS minutes CMS refinement (min or qty) 6 3 L1: Refined time to standard for this 4 6 3 L1: Refined time to standard for this —Continued 3 60 15 0 G1: See preamble text MS minutes 0 G1: See preamble text MS minutes 45 15 0 G1: See preamble text MS minutes 0 G1: See preamble text MS minutes 190 ABLE T RUC (min or qty) or current value recommendation ... 190 187 G1: See preamble text MS minutes ... 34 85 E1: Refined equipment time to con- .... 72 69 E15: Refined equipment time to con- ...... 34 85 E1: Refined equipment time to con- EFINEMENT ...... 190 187 G1: See preamble text MS minutes PE R Labor activity (where applicable) IRECT physician staff. forming Procedure (CS). erate sedation. physician staff. forming Procedure (CS). erate sedation. D ULE R NF ...... 190 187 G1: See preamble text MS minutes NF ...... 190 187 G1: See preamble text MS minutes INAL 28—CY 2017 F Input code description NF/F NIBP, temp, resp). NIBP, temp, resp). ABLE T code Input EF018 ...... stretcher ...... EF027 ...... NF mobileinstrument, ...... table, EL011 NF ...... angiography room, ...... NF EQ011 ..... ECG, 3-channel (with SpO2, ...... EQ032 .....pumpinfusion IV ...... 190 EQ168 NF .....exam 190 light, ...... NF EQ250 ...... 57 187 ..... G1: See preamble text MS minutes ultrasound unit, portable ...... 187 G1: See preamble text MS minutes NF L041B ...... 190 ...... Radiologic Technologist ...... 54 L051A E15: Refined equipment time to con- ...... NF 34 RN ...... L051A ...... Clean room/equipment by NF RN 187 G1: See preamble text MS minutes ...... L051A ...... NF Assist Physician in Per- RN 34 ...... SA044 ...... 70 sedation NF Monitor pt. following mod- conscious E1: Refined equipment time to con- ...... pack, NF anesthesia Sedate/Apply ...... 70 E1: Refined equipment time 2 1 0 G1: See preamble text MS minutes 0 G1: See preamble text MS suppl cholangiogram. cholangiogram. cholangiogram. cholangiogram. cholangiogram. cholangiogram. cholangiogram. cholangiogram. cholangiogram. cholangiogram. cholangiogram. cholangiogram. HCPCS code description code HCPCS 47532 .... Injection for 47532 .... Injection for 47532 .... Injection for 47532 .... Injection for 47532 .... Injection for 47532 .... Injection for 47532 .... Injection for 47532 .... Injection for 47532 .... Injection for 47532 .... Injection for 47532 .... Injection for 47532 .... Injection for 47533 .... Plmt biliary drainage cath ED050 ...... 47533 PACS Workstation Proxy ...... Plmt biliary drainage cath NF 47533 .... EF018 ...... Plmt biliary drainage cath ...... 47533 stretcher ...... EF027 ...... Plmt biliary drainage cath NF table, instrument, mobile ...... EL01147533 ...... NF ...... room, angiography Plmt biliary drainage cath ...... 47533 ...... NF EQ011 ..... Plmt biliary drainage cath47533 ECG, ...... EQ032 3-channel ..... Plmt biliary drainage cath (with SpO2, IV infusion pump ...... EQ168 ..... NF 47533 light, exam ...... Plmt biliary drainage cath NF ...... EQ250 ...... 47533 ultrasound unit, portable ...... Plmt biliary drainage cath NF 47533 .... L041B ...... Plmt biliary drainage cath ...... 47533 Radiologic Technologist ...... L051A ...... Plmt biliary drainage cath NF RN ...... L051A ...... Clean room/equipment by NF RN ...... NF Assist Physician in Per- Monitor pt. following mod-

VerDate Sep<11>2014 22:03 Nov 11, 2016 Jkt 241001 PO 00000 Frm 00208 Fmt 4701 Sfmt 4700 E:\FR\FM\15NOR2.SGM 15NOR2 mstockstill on DSK3G9T082PROD with RULES2 Federal Register / Vol. 81, No. 220 / Tuesday, November 15, 2016 / Rules and Regulations 80377 1.43 0.26 0.92 0.00 0.16 0.00 6.86 ¥ 0.02 ¥ 0.04 ¥ 0.02 ¥ 0.02 ¥ 0.04 ¥ 0.02 ¥ 1.02 ¥ 1.02 ¥ 1.23 ¥ 7.65 ¥ 1.23 ¥ 7.65 ¥ 1.02 ¥ 17.31 ¥ 17.31 ¥ 15.76 ¥ 15.76 ¥ 17.31 ¥ 34.68 ¥ 22.95 backed out input. form to established policies for PACS Workstation Proxy MS minutes backed out input. backed out input. form to changes in clinical labor time MS minutes backed out input. backed out input. backed out input. form to established policies for non- highly technical equipment MS minutes backed out input. backed out input. form to established policies for PACS Workstation Proxy MS minutes backed out input. backed out input. backed out input. form to changes in clinical labor time MS minutes backed out input. backed out input. backed out input. form to established policies for non- highly technical equipment MS minutes backed out input. backed out input. backed out input. form to established policies for non- highly technical equipment MS minutes backed out input. backed out input. backed out input. clinical labor task. backed out input. backed out input. clinical labor task. backed out input. backed out input. backed out input. G1: See preamble text MS minutes G1: See preamble text MS minutes 0 0 0 G1: See preamble text MS minutes 99 E18: Refined equipment time to con- 70 E1: Refined equipment time to con- 187 G1: See preamble text MS minutes 4 6 3 L1: Refined time to standard for this 6 3 L1: Refined time to standard for this 2 2 2 34 3 68 15 0 G1: See preamble text MS minutes 0 G1: See preamble text MS minutes 45 15 0 G1: See preamble text MS minutes 0 G1: See preamble text MS minutes 190 . 1 0 G1: See preamble text MS supply .. 1 34 0 G1: See preamble text MS supply 76 E18: Refined equipment time to con- ... 190 187 G1: See preamble text MS minutes ... 34 93 E1: Refined equipment time to con- ... 1 0 G1: See preamble text MS supply .... 80 77 E15: Refined equipment time to con- ..... 190 187 G1: See preamble text MS minutes ...... 57 54 E15: Refined equipment time to con- ...... 190 187 G1: See preamble text MS minutes ...... 34 93 E1: Refined equipment time to con- ...... 190 187 G1: See preamble text MS minutes ...... 190 187 G1: See preamble text MS minutes physician staff. forming Procedure (CS). erate sedation. physician staff. forming Procedure (CS). erate sedation. NF ...... 190 187 G1: See preamble text MS minutes NF ...... 190 187 G1: See preamble text MS minutes NIBP, temp, resp). NIBP, temp, resp). 47533 .... Plmt biliary drainage cath47533 .... L051A ...... Plmt biliary drainage cath47534 RN ...... SA044 ...... Plmt biliary drainage cath NF pack, conscious sedation ...... ED050 ...... NF Sedate/Apply anesthesia47534 .. PACS Workstation Proxy ...... Plmt biliary drainage cath NF ...... 47534 .... EF018 ...... Plmt biliary drainage cath ...... 47534 stretcher ...... EF027 ...... Plmt biliary drainage cath NF table, instrument, mobile ...... EL01147534 ...... NF ...... room, angiography Plmt biliary drainage cath ...... 47534 .... NF ...... EQ011 Plmt biliary drainage cath .....47534 ECG, ...... EQ032 3-channel Plmt biliary drainage cath ..... (with IV infusion pump SpO2, ...... EQ168 ..... NF 47534 light, exam ...... Plmt biliary drainage cath NF ...... EQ250 ...... 47534 ultrasound unit, portable ...... Plmt biliary drainage cath NF 47534 .... L041B ...... Plmt biliary drainage cath ...... 47534 Radiologic Technologist ...... L051A ...... Plmt biliary drainage cath NF 47534 RN ...... L051A ...... Plmt biliary drainage cath Clean room/equipment by NF 47534 RN ...... L051A ...... Plmt biliary drainage cath NF Assist Physician in Per- 47535 RN ...... SA044 ...... Conversion ext bil drg cath NF Monitor pt. following mod- ED050 pack, conscious sedation ...... PACS Workstation Proxy NF ...... Sedate/Apply anesthesia47535 ...... NF Conversion ext bil drg cath ...... 47535 EF018 ...... stretcher Conversion ext bil drg cath ...... 47535 EF027 ...... NF table, instrument, mobile Conversion ext bil drg cath ...... EL011 ...... NF ...... 47535 room, angiography ...... Conversion ext bil drg cath NF ...... 47535 EQ011 ...... Conversion ext bil drg cath ECG, 47535 ...... EQ032 3-channel ...... (with Conversion ext bil drg cath IV infusion pump SpO2, ...... EQ168 ..... NF light, exam ...... 47535 .... NF ...... Conversion ext bil drg cath 47535 L041B ...... Conversion ext bil drg cath Radiologic Technologist ...... 47535 L051A ...... NF Conversion ext bil drg cath RN ...... 47535 L051A ...... Clean room/equipment by NF Conversion ext bil drg cath RN ...... 47535 L051A ...... NF Assist Physician in Per- Conversion ext bil drg cath RN ...... SA044 ...... NF Monitor pt. following mod- pack, conscious sedation ...... NF Sedate/Apply anesthesia ......

VerDate Sep<11>2014 22:03 Nov 11, 2016 Jkt 241001 PO 00000 Frm 00209 Fmt 4701 Sfmt 4700 E:\FR\FM\15NOR2.SGM 15NOR2 mstockstill on DSK3G9T082PROD with RULES2 80378 Federal Register / Vol. 81, No. 220 / Tuesday, November 15, 2016 / Rules and Regulations 0.37 0.00 0.05 1.10 ¥ 0.04 ¥ 0.02 ¥ 1.02 ¥ 0.11 ¥ 0.03 ¥ 1.23 ¥ 7.65 ¥ 0.03 ¥ 0.01 ¥ 0.07 ¥ 5.55 ¥ 1.23 ¥ 1.02 ¥ 0.02 ¥ 0.05 costs ¥ 15.76 ¥ 17.31 ¥ 15.76 ¥ 10.20 Direct change Comment form to established policies for PACS Workstation Proxy MS minutes backed out input. backed out input. backed out input. backed out input. form to established policies for non- highly technical equipment MS minutes backed out input. backed out input. form to changes in clinical labor time. form to established policies for non- highly technical equipment. form to established policies for PACS Workstation Proxy MS minutes backed out input. backed out input. form to changes in clinical labor time MS minutes backed out input. backed out input. form to established policies for PACS Workstation Proxy. clinical labor task. backed out input. backed out input. ated with moderate sedation; moderate sedation not typical for this procedure. clinical labor task. ated with moderate sedation; moderate sedation not typical for this procedure. 1: See preamble text MS minutes 0 G 0 L11: Removed clinical labor associ- 51 E18: Refined equipment time to con- 82 G1: See preamble text82 ...... G1: See preamble text ...... 82 G1: See preamble text ...... CMS refinement (min or qty)

6 3 L1: Refined time to standard for this 6 3 L1: Refined time to standard for this 2 1 0 G1: See preamble text MS supply 2 —Continued 51 46 E18: Refined equipment time to con- 87 15 0 L11: Removed clinical labor associ- 34 84 E18: Refined equipment time to con- 34 87 87 20 15 0 G1: See preamble text MS minutes 0 G1: See preamble text MS minutes ABLE T RUC (min or qty) or current value recommendation .. 70 67 G1: See preamble text MS minutes ... 32 29 E15: Refined equipment time to con- .... 70 67 G1: See preamble text MS minutes ..... 27 24 E15: Refined equipment time to con- ...... 34 45 E1: Refined equipment time to con- EFINEMENT ...... 51 40 E1: Refined equipment time to con- ...... 70 67 G1: See preamble text MS minutes PE R Labor activity (where applicable) IRECT physician staff. forming Procedure (CS). erate sedation. forming procedure. physician staff. D ULE R NF ...... 70 67 G1: See preamble text MS minutes NF ...... 87 82 G1: See preamble text ...... INAL 28—CY 2017 F Input code description NF/F NIBP, temp, resp). NIBP, temp, resp). ABLE T code Input HCPCS code description code HCPCS 47536 .... Exchange biliary drg cath ED050 ...... 47536 PACS Workstation Proxy ...... Exchange biliary drg cath NF 47536 .... EF018 ...... Exchange biliary drg cath ...... 47536 stretcher ...... EF027 ...... NF Exchange biliary drg cath table, instrument, mobile ...... EL01147536 ...... NF .... room, angiography Exchange biliary drg cath ...... 47536 ...... NF EQ011 ..... Exchange biliary drg cath47536 ECG, ...... EQ032 3-channel ..... Exchange biliary drg cath (with SpO2, IV infusion pump ...... EQ168 ..... NF 47536 light, exam ...... Exchange biliary drg cath NF ...... 47536 .... L041B ...... Exchange biliary drg cath ...... 47536 Radiologic Technologist ...... L051A ...... Exchange biliary drg cath NF 47536 RN ...... L051A ...... Exchange biliary drg cath Clean room/equipment by NF 47536 RN ...... L051A ...... Exchange biliary drg cath Assist Physician in Per- NF 47537 RN ...... SA044 ...... Removal biliary drg cath Monitor pt. following mod- NF ... pack, conscious sedation ...... ED050 ...... 47537 NF .... Sedate/Apply anesthesia PACS Workstation Proxy .. 47537 ...... Removal biliary drg cath ...... 47537 NF Removal biliary drg cath ...... EF018 ...... Removal biliary drg cath EF027 ... stretcher ...... EL011 table, instrument, mobile NF 47537 ...... room, angiography NF Removal biliary drg cath ...... 47537 ...... NF .... EQ01147537 ...... Removal biliary drg cath ...... ECG, ...... Removal biliary drg cath EQ032 3-channel ...... (with EQ168 SpO2, IV infusion pump47537 ...... light, exam NF ...... Removal biliary drg cath ... NF L037D ...... RN/LPN/MTA47537 ...... NF Removal biliary drg cath ...47537 .... L041B ...... Assist physician in per- Removal biliary drg cath ... Radiologic Technologist ...... L051A ...... NF RN47538 ...... Clean room/equipment by NF Perq plmt bile duct stent .. ED050 ...... Sedate/Apply anesthesia .. PACS Workstation Proxy ...... NF ......

VerDate Sep<11>2014 22:03 Nov 11, 2016 Jkt 241001 PO 00000 Frm 00210 Fmt 4701 Sfmt 4700 E:\FR\FM\15NOR2.SGM 15NOR2 mstockstill on DSK3G9T082PROD with RULES2 Federal Register / Vol. 81, No. 220 / Tuesday, November 15, 2016 / Rules and Regulations 80379 0.00 0.19 1.59 0.00 0.29 7.67 ¥ 0.04 ¥ 0.02 ¥ 0.04 ¥ 0.02 ¥ 0.02 ¥ 1.02 ¥ 0.02 ¥ 1.02 ¥ 1.23 ¥ 7.65 ¥ 1.23 ¥ 7.65 130.00 130.00 ¥ 15.76 ¥ 15.76 ¥ 17.31 ¥ 17.31 ¥ 27.03 ¥ 38.25 ¥ 487.00 ¥ 487.00 backed out input. form to changes in clinical labor time MS minutes backed out input. backed out input. backed out input. form to established policies for non- highly technical equipment MS minutes backed out input. backed out input. item; see preamble. item; see preamble. form to established policies for PACS Workstation Proxy MS minutes backed out input. backed out input. form to changes in clinical labor time MS minutes backed out input. backed out input. backed out input. form to established policies for non- highly technical equipment MS minutes backed out input. form to changes in clinical labor time MS minutes backed out input. backed out input. item; see preamble. item; see preamble. backed out input. backed out input. backed out input. backed out input. clinical labor task. backed out input. backed out input. clinical labor task. backed out input. backed out input. G1: See preamble text MS minutes G1: See preamble text MS minutes 0 0 0 2 S8: Supply item replaces another 0 2 S8: Supply item replaces another 6 3 L1: Refined time to standard for this 6 3 L1: Refined time to standard for this 2 2 34 106 E18: Refined equipment time to con- 53 15 0 G1: See preamble text MS minutes 0 G1: See preamble text MS minutes 75 15 0 G1: See preamble text MS minutes 0 G1: See preamble text MS minutes .. 1 0 G1: See preamble text MS supply .. 1 0 G1: See preamble text MS supply .... 190 187 G1: See preamble text MS minutes .... 190 187 G1: See preamble text MS minutes .... 34 100 E15: Refined equipment time to con- ..... 65 62 E15: Refined equipment time to con- ..... 2 ..... 0 S7: Supply item replaced by another 87 84 E15: Refined equipment time to con- ..... 2 0 S7: Supply item replaced by another ...... 190 187 G1: See preamble text MS minutes ...... 190 187 G1: See preamble text MS minutes ...... 34 78 E1: Refined equipment time to con- ...... 34 100 E1: Refined equipment time to con- ...... 190 187 G1: See preamble text MS minutes ...... 190 187 G1: See preamble text MS minutes physician staff. forming Procedure (CS). erate sedation. physician staff. forming Procedure (CS). erate sedation. NF ...... 190 187 G1: See preamble text MS minutes NF ...... 190 187 G1: See preamble text MS minutes NIBP, temp, resp). NIBP, temp, resp). 47538 .... Perq plmt bile duct stent ..47538 .... EF018 ...... Perq plmt bile duct stent ..47538 stretcher ...... EF027 ...... NF Perq plmt bile duct stent .. table, instrument, mobile ...... EL01147538 ...... NF .... room, angiography Perq plmt bile duct stent ...... 47538 ...... NF EQ011 ..... Perq plmt bile duct stent ..47538 ECG, ...... EQ032 3-channel ..... Perq plmt bile duct stent (with .. SpO2, IV infusion pump ...... EQ168 ..... NF 47538 light, exam ...... Perq plmt bile duct stent NF ...... 47538 .... L041B ...... Perq plmt bile duct stent ...... 47538 Radiologic Technologist ...... L051A ...... Perq plmt bile duct stent NF ..47538 RN ...... L051A ...... Perq plmt bile duct stent Clean room/equipment by NF ..47538 RN ...... L051A ...... Perq plmt bile duct stent NF Assist Physician in Per- ..47538 RN ...... SA044 ...... Perq plmt bile duct stent NF Monitor pt. following mod- ..47538 pack, conscious sedation ...... SD150 ...... NF Perq plmt bile duct stent Sedate/Apply anesthesia .. .. 47539 catheter, balloon ureteral (Dowd) .... SD152 NF ...... Perq plmt bile duct stent ...... catheter, balloon, PTA ...... ED050 ...... NF 47539 PACS Workstation Proxy ...... NF Perq plmt bile duct stent ..47539 .... EF018 ...... Perq plmt bile duct stent ...... 47539 stretcher ...... EF027 ...... NF Perq plmt bile duct stent .. table, instrument, mobile ...... EL01147539 ...... NF ...... room, angiography Perq plmt bile duct stent ...... 47539 ...... NF EQ011 ..... Perq plmt bile duct stent ..47539 ECG, ...... EQ032 3-channel ..... Perq plmt bile duct stent (with .. SpO2, IV infusion pump ...... EQ168 ..... NF 47539 light, exam ...... Perq plmt bile duct stent NF ...... EQ25047539 ...... ultrasound unit, portable Perq plmt bile duct stent ...... 47539 NF .... L041B ...... Perq plmt bile duct stent ..47539 Radiologic Technologist ...... L051A ...... Perq plmt bile duct stent NF ..47539 RN ...... L051A ...... Perq plmt bile duct stent Clean room/equipment by NF ..47539 RN ...... L051A ...... Perq plmt bile duct stent NF Assist Physician in Per- ..47539 RN ...... SA044 ...... Perq plmt bile duct stent NF Monitor pt. following mod- ..47539 pack, conscious sedation ...... SD150 ...... NF Perq plmt bile duct stent Sedate/Apply anesthesia .. .. catheter, balloon ureteral (Dowd) SD152 NF ...... catheter, balloon, PTA ...... NF ......

VerDate Sep<11>2014 22:03 Nov 11, 2016 Jkt 241001 PO 00000 Frm 00211 Fmt 4701 Sfmt 4700 E:\FR\FM\15NOR2.SGM 15NOR2 mstockstill on DSK3G9T082PROD with RULES2 80380 Federal Register / Vol. 81, No. 220 / Tuesday, November 15, 2016 / Rules and Regulations 1.81 0.00 0.33 8.83 1.26 0.00 0.22 ¥ 0.04 ¥ 0.02 ¥ 0.02 ¥ 1.02 ¥ 1.23 ¥ 7.65 ¥ 0.02 ¥ 0.02 ¥ 0.04 130.00 costs ¥ 15.76 ¥ 17.31 ¥ 43.35 ¥ 15.76 Direct change ¥ 487.00 nt time to con- Comment form to established policies for PACS Workstation Proxy MS minutes backed out input. backed out input. form to changes in clinical labor time MS minutes backed out input. backed out input. backed out input. form to established policies for non- highly technical equipment MS minutes backed out input. form to changes in clinical labor time MS minutes backed out input. backed out input. item; see preamble SD152. item; see preamble SD150. backed out input. backed out input. clinical labor task. backed out input. backed out input. form to established policies for PACS Workstation Proxy MS minutes backed out input. backed out input. backed out input. form to changes in clinical labor time MS minutes backed out input. backed out input. backed out input. form to established policies for non- highly technical equipment MS minutes backed out input. G1: See preamble text MS minutes 0 CMS refinement (min or qty) 0 2 S8: Supply item replaces another 6 3 L1: Refined time to standard for this 2 —Continued 34 116 E18: Refined equipment time to con- 85 15 0 G1: See preamble text MS minutes 0 G1: See preamble text MS minutes ABLE T RUC (min or qty) or current value recommendation .. 1 0 G1: See preamble text MS supply .... 190 187 G1: See preamble text MS minutes .... 34 110 E15: Refined equipment time to con- ..... 97 94 E15: Refined equipment time to con- ..... 2 0 S7: Supply item replaced by another ...... 190 187 G1: See preamble text MS minutes EFINEMENT ...... 34 110 E1: Refined equipment time to con- ...... 190 187 G1: See preamble text MS minutes PE R Labor activity (where applicable) IRECT physician staff. forming Procedure (CS). erate sedation. D ULE R NF ...... 190 187 G1: See preamble text MS minutes NF ...... 190 187 G1: See preamble text MS minutes INAL 28—CY 2017 F Input code description NF/F NIBP, temp, resp). NIBP, temp, resp). ABLE T code Input ED050 ...... ProxyWorkstation PACS ...... NF EF018 ...... stretcher ...... EF027 ...... NF mobileinstrument, ...... table, EL011 NF ...... angiography room, ...... NF 34 EQ011 ..... ECG, 3-channel (with SpO2, ...... EQ032 .....pumpinfusion 190 IV ...... EQ168 NF ..... 190 91 exam light, E18: Refined equipment time to con- ...... NF 187 72 ...... G1: See preamble text MS minutes 187 G1: See preamble text MS minutes 190 69 E15: Refined equipment time to con- 34 187 G1: See preamble text MS minutes 85 E1: Refined equipme bwl. bwl. bwl. bwl. bwl. bwl. bwl. HCPCS code description code HCPCS 47540 .... Perq plmt bile duct stent .. ED050 ...... PACS Workstation Proxy47540 ...... NF Perq plmt bile duct stent ..47540 .... EF018 ...... Perq plmt bile duct stent .. stretcher47540 ...... EF027 ...... NF Perq plmt bile duct stent .. table, instrument, mobile ...... EL01147540 ...... NF .... room, angiography Perq plmt bile duct stent ...... 47540 ...... NF .... EQ011 ..... Perq plmt bile duct stent ..47540 ECG, ...... 3-channel EQ032 ..... (with Perq plmt bile duct stent .. SpO2, IV infusion pump ...... EQ168 ..... NF 47540 light, exam ...... Perq plmt bile duct stent NF ...... EQ25047540 ...... ultrasound unit, portable Perq plmt bile duct stent ...... 47540 NF .... L041B ...... Perq plmt bile duct stent .. Radiologic Technologist47540 ...... L051A ...... NF Perq plmt bile duct stent .. RN47540 ...... L051A ...... Clean room/equipment by NF Perq plmt bile duct stent .. RN47540 ...... L051A ...... Assist Physician in Per- NF Perq plmt bile duct stent .. RN47540 ...... SA044 ...... Monitor pt. following mod- NF Perq plmt bile duct stent .. pack, conscious sedation47540 ...... SD150 ...... NF Sedate/Apply anesthesia Perq plmt bile duct stent .. .. catheter, balloon ureteral (Dowd) 47541 .... SD152 NF ...... Plmt access bil tree sm catheter, balloon, PTA ...... NF 47541 ...... Plmt access bil tree sm 47541 .... Plmt access bil tree sm 47541 .... Plmt access bil tree sm 47541 .... Plmt access bil tree sm 47541 .... Plmt access bil tree sm 47541 .... Plmt access bil tree sm

VerDate Sep<11>2014 22:03 Nov 11, 2016 Jkt 241001 PO 00000 Frm 00212 Fmt 4701 Sfmt 4700 E:\FR\FM\15NOR2.SGM 15NOR2 mstockstill on DSK3G9T082PROD with RULES2 Federal Register / Vol. 81, No. 220 / Tuesday, November 15, 2016 / Rules and Regulations 80381 7.82 3.08 5.93 65.00 65.00 ¥ 0.15 ¥ 0.04 ¥ 0.42 ¥ 0.15 ¥ 0.04 ¥ 0.42 ¥ 0.23 ¥ 0.06 ¥ 0.63 ¥ 7.82 ¥ 0.19 ¥ 0.19 ¥ 0.28 ¥ 1.70 ¥ 7.65 ¥ 1.23 ¥ 1.02 ¥ 17.31 ¥ 30.60 ¥ 15.30 ¥ 15.30 ¥ 22.95 ¥ 243.50 ¥ 243.50 ¥ 417.00 to con- ...... 5.25 backed out input. backed out input. backed out input. item; see preamble. item; see preamble. backed out input. backed out input. backed out input. backed out input. backed out input. backed out input. item; see preamble. item; see preamble. item; see preamble SD030. backed out input. backed out input. backed out input. item; see preamble SD030. item; see preamble SD024. item; see preamble SD030. form to established policies for non- highly technical equipment MS minutes backed out input. backed out input. backed out input. clinical labor task. backed out input. backed out input. backed out input. backed out input. backed out input. 0 G1: See preamble text MS minutes 0 G1: See preamble text MS minutes 0 G1: See preamble text ...... 0 G1: See preamble text MS minutes 1 G1: See preamble text ...... 417.00 1 S8: Supply item replaces another 62 G1: See preamble text62 ...... G1: See preamble text ...... 5.25 5.25 1 0 0 6 3 L1: Refined time to standard for this 30 30 45 60 15 0 G1: See preamble text MS minutes 0 G1: See preamble text MS minutes 61 61 30 0 G1: See preamble text MS minutes 30 0 G1: See preamble text MS minutes 45 0 G1: See preamble text MS minutes . 0 1 S8: Supply item replaces another . 0 1 S8: Supply item replaces another ..... 30 0 G1: See preamble text MS minutes ..... 30 ..... 0 G1: See preamble text MS minutes 45 0 G1: See preamble text MS minutes ...... 1 0 S7: Supply item replaced by another ...... 1 0 S7: Supply item replaced by another ...... 1 0 S7: Supply item replaced by another ...... 0 1 1 S8: Supply item replaces another 0 S7: Supply item replaced by another ...... 30 0 G1: See preamble text MS minutes ...... 30 ...... 0 G1: See preamble text MS minutes 45 0 G1: See preamble text MS minutes physician staff. forming Procedure (CS). erate sedation. forming Procedure (CS). forming Procedure (CS). forming Procedure (CS). NF ...... 30 NF 0 G1: See preamble text MS minutes ...... 30 NF ...... 0 G1: See preamble text MS minutes 45 0 G1: See preamble text MS minutes NIBP, temp, resp). NIBP, temp, resp). NIBP, temp, resp). EQ250 ..... ultrasound unit, portable ...... NF L041B ...... Radiologic Technologist ...... L051A ...... NF RN ...... L051A ...... Clean room/equipment by NF RN ...... L051A ...... NF Assist Physician in Per- RN 34 ...... SA044 ...... sedation NF Monitor pt. following mod- conscious ...... pack, NF anesthesia Sedate/Apply ...... 85 E1: Refined equipment time 2 1 0 G1: See preamble text MS minutes 0 G1: See preamble text MS suppl y EL011 ...... room, angiography ...... NF ...... 46 47 G1: See preamble text .... bwl. bwl. bwl. bwl. bwl. bwl. plvs. 47541 .... Plmt access bil tree sm 47541 .... Plmt access bil tree sm 47541 .... Plmt access bil tree sm 47541 .... Plmt access bil tree sm 47541 .... Plmt access bil tree sm 47541 .... Plmt access bil tree sm 47542 .... Dilate biliary duct/ampulla 47542 .... EF018 ...... Dilate biliary duct/ampulla stretcherduct/ampulla 47542 ...... EQ011 .... EF027biliary ...... NF Dilate ECG, 3-channel (with Sp02, table, instrument, mobile47542 ...... NF ...... Dilate biliary duct/ampulla 47542 .... EQ032 ...... Dilate biliary duct/ampulla IV infusion pump47542 ...... L051A ...... NF Dilate biliary duct/ampulla RN47542 ...... SD150 ...... NF Dilate biliary duct/ampulla ...... catheter, balloon ureteral (Dowd) 47543 .... SD152 NF ...... Assist Physician in Per- Endoluminal bx biliary tree catheter, balloon, PTA47543 ...... EF018 ...... NF Endoluminal bx biliary tree stretcher ...... 47543 EF027 ...... NF ...... Endoluminal bx biliary tree table, instrument, mobile ...... 47543 EQ011 ...... NF ...... Endoluminal bx biliary tree ECG, 47543 EQ032 3-channel ...... (with Endoluminal bx biliary tree IV infusion pump Sp02, 47543 ...... L051A ...... 47544 NF Endoluminal bx biliary tree .... RN ...... SD315 Removal duct glbldr calculi ...... NF 47544 EF018 ...... Stone basket ...... stretcher Removal duct glbldr calculi ...... NF 47544 Assist Physician in Per- EF027 ...... NF table, instrument, mobile Removal duct glbldr calculi ...... 47544 EQ011 ...... NF ...... Removal duct glbldr calculi ECG, 47544 EQ032 3-channel ...... (with Removal duct glbldr calculi IV infusion pump Sp02, ...... 47544 L051A ...... NF Removal duct glbldr calculi RN ...... 47544 SD150 ...... NF ...... catheter, balloon ureteral (Dowd) Removal duct glbldr calculi 47544 SD152 NF ...... Assist Physician in Per- 50606 catheter, balloon, PTA Removal duct glbldr calculi ...... SD315 ...... Endoluminal bx urtr rnl NF 50705 Stone basket ...... 50706 Ureteral embolization/occl ...... NF 51700 Balloon dilate urtrl strix .... EL011 ...... Irrigation of bladder EL011 ...... room, angiography ...... 51700 ...... SD024 room, angiography ...... NF Irrigation of bladder ...... 51700 catheter, Foley ...... NF .... SD030 ...... NF Irrigation of bladder ...... 51701 catheter, straight ...... SJ031 NF ...... Insert bladder catheter ..... leg or urinary drainage bag ...... SD024 ...... NF catheter, Foley ...... NF ......

VerDate Sep<11>2014 22:03 Nov 11, 2016 Jkt 241001 PO 00000 Frm 00213 Fmt 4701 Sfmt 4700 E:\FR\FM\15NOR2.SGM 15NOR2 mstockstill on DSK3G9T082PROD with RULES2 80382 Federal Register / Vol. 81, No. 220 / Tuesday, November 15, 2016 / Rules and Regulations 1.70 0.08 0.65 0.01 0.01 0.01 0.01 0.01 0.01 0.14 0.01 0.01 1.11 1.11 0.01 ¥ 0.10 ¥ 3.91 ¥ 0.62 ¥ 0.12 ¥ 3.08 costs Direct change Comment item; see preamble SD024. form to established policies for scopes. form to established policies for scopes. form to established policies for scopes. dundancy when used together with equipment EQ378. EQ378. EQ378. form to established policies for non- highly technical equipment. form to established policies for non- highly technical equipment. form to established policies for non- highly technical equipment. form to established policies for non- highly technical equipment. form to established policies for non- highly technical equipment. form to established policies for non- highly technical equipment. form to established policies for PACS Workstation Proxy. item; see preamble SD030. form to established policies for scopes. form to established policies for non- highly technical equipment. form to established policies for non- highly technical equipment. clinical labor task. clinical labor task. 0 E9: Equipment removed due to re- 22 E18: Refined equipment time to con- 75 E1: Refined equipment time to con- 75 E1: Refined equipment time to con- 75 E1: Refined equipment time to con- 75 E1: Refined equipment time to con- CMS refinement (min or qty)

1 0 3 L1: Refined time to standard for this 0 3 L1: Refined time to standard for this —Continued 73 73 73 73 5 24 ABLE T RUC (min or qty) or current value recommendation ... 1 0 S7: Supply item replaced by another ...... 1 1 0 S1: Duplicative; supply is included in 0 S1: Duplicative; supply is included in ...... 17 22 E4: Refined equipment time to con- EFINEMENT ...... 0 1 S8: Supply item replaces another ...... 17 22 E4: Refined equipment time to con- ...... 73 75 ...... E1: Refined equipment time to con- 73 75 E1: Refined equipment time to con- ...... 73 75 ...... E1: Refined equipment time to con- 73 75 E1: Refined equipment time to con- ...... 17 22 E4: Refined equipment time to con- PE R Labor activity (where applicable) IRECT prescriptions. prescriptions. D ULE R NF ...... NF 17 ...... 22 E4: Refined equipment time to con- 0 1 G1: See preamble text ...... 320.00 INAL 28—CY 2017 F Input code description NF/F essor, digital capture, monitor, printer, cart). tubing kit. ABLE T code Input HCPCS code description code HCPCS 51701 .... Insert bladder catheter .....51701 .... SD030 ...... Insert bladder catheter ..... catheter, straight52000 ...... SJ031 NF ...... Cystoscopy ...... leg or urinary drainage bag ...... EF02752000 ...... NF .... table, instrument, mobile ...... Cystoscopy ...... NF ...... EF03152000 ...... table, power ...... Cystoscopy ...... NF EQ16752000 ...... light source, xenon ...... Cystoscopy ...... NF ES03158555 ...... video system, endoscopy (proc- ...... Hysteroscopy dx sep proc 58558 L037D ...... Hysteroscopy biopsy RN/LPN/MTA ...... EQ235 F 58558 ...... suction machine (Gomco)biopsy Hysteroscopy ...... 58558 Conduct phone calls/call in NF .... SA123 ...... Hysteroscopy biopsy Hysteroscopic fluid management ...... 58558 ...... SD009 ...... Hysteroscopy biopsy ...... canister, suction58562 ...... SD031 ...... NF Hysteroscopy remove fb ... catheter, suction62321 ...... L037D ...... NF ...... Njx interlaminar crv/thrc .... RN/LPN/MTA ...... EF018 ...... F 62321 ...... stretcher ...... Njx interlaminar crv/thrc .... NF EQ211 Conduct phone calls/call in 62323 ...... pulse oximeter w-printer ...... Njx interlaminar lmbr/sac .. NF EF018 ...... 62323 .... stretcher ...... Njx interlaminar lmbr/sac .. NF EQ21162325 ...... pulse oximeter w-printer ...... Njx interlaminar crv/thrc .... NF EF018 ...... 62325 .... stretcher ...... Njx interlaminar crv/thrc .... NF EQ21162327 ...... pulse oximeter w-printer ...... Njx interlaminar lmbr/sac .. NF EF018 ...... 62327 .... stretcher ...... Njx interlaminar lmbr/sac .. NF EQ21170540 ...... pulse oximeter w-printer ...... Mri orbit/face/neck w/o dye ED053 NF ...... Professional PACS Workstation ...... NF ......

VerDate Sep<11>2014 22:03 Nov 11, 2016 Jkt 241001 PO 00000 Frm 00214 Fmt 4701 Sfmt 4700 E:\FR\FM\15NOR2.SGM 15NOR2 mstockstill on DSK3G9T082PROD with RULES2 Federal Register / Vol. 81, No. 220 / Tuesday, November 15, 2016 / Rules and Regulations 80383 ¥ 0.04 ¥ 2.79 ¥ 0.12 ¥ 0.12 ¥ 0.04 ¥ 2.79 ¥ 0.82 ¥ 0.82 ¥ 0.04 ¥ 2.79 ¥ 0.82 ¥ 0.33 ¥ 1.32 ¥ 0.90 ¥ 1.35 ¥ 1.35 ¥ 5.10 form to changes in clinical labor time. form to changes in clinical labor time. form to established policies for PACS Workstation Proxy. form to established policies for PACS Workstation Proxy. form to changes in clinical labor time. form to changes in clinical labor time. clinical labor task not typical; see preamble text. clinical labor task not typical; see preamble text. form to changes in clinical labor time. form to changes in clinical labor time. clinical labor task not typical; see preamble text. clinical labor task. and/or not individually allocable to a particular patient for service. form with identical labor activity in other codes in the family. form with identical labor activity in other codes in the family. clinical labor task. 23 E18: Refined equipment time to con- 2 0 L6: Add-on code. Additional time for 2 0 L6: Add-on code. Additional time for 2 0 L6: Add-on code. Additional time for 2 1 4 L1: Refined time to standard for this 0 G6: Indirect Practice Expense input 5 2 L1: Refined time to standard for this 25 24 22 E15: Refined equipment time to con- 15 13 L3: Refined clinical labor time to con- 10 7 L3: Refined clinical labor time to con- . 27 25 E15: Refined equipment time to con- supplies. supplies. supplies. lowing procedure (including any equipment maintenance that must be done after the procedure). information system, multiparameter analyses and field data entry, complete quality assurance documentation. control functions, calibration, centrifugation, maintaining specimen tracking, logs and labeling. cytometer, run specimen, monitor data acquisition, and data modeling, and unload flow cytometer. semble materials with paperwork to pathologists. NF ...... 1.6 1 G1: See preamble text ...... test). ED053 ...... WorkstationPACS Professional .. NF ED050 ...... ProxyWorkstation ...... PACS ...... NF EL014 ...... radiographic-fluoroscopic ...... room, .. NF L041B ...... Radiologic Technologist ...... 30 ...... NF Prepare room, equipment, 27 28 E18: Refined equipment time to co n- 24 25 E15: Refined equipment time to con- ED050 ...... ProxyWorkstation PACS 22 ...... E15: Refined equipment time to con- NF EL014 ...... radiographic-fluoroscopic ...... room, .. NF L041B ...... Radiologic Technologist ...... NF Prepare room, equipment, 27 24 25 E15: Refined equipment time to con- 22 E15: Refined equipment time to con- dye. vice. vice. vice. ject. ject. ject. 70542 .... Mri orbit/face/neck w/dye .. ED053 ...... 70543 .... Professional PACS Workstation .. Mri orbt/fac/nck w/o &w/ NF 77001 ...... Fluoroguide for vein de- 77001 .... Fluoroguide for vein de- 77001 .... Fluoroguide for vein de- 77002 .... Needle localization by xray ED050 ...... 77002 PACS Workstation Proxy ...... Needle localization by xray NF EL014 ...... 77002 room, radiographic-fluoroscopic ...... Needle localization by xray NF L041B ...... 77003 Radiologic Technologist ...... Fluoroguide for spine in- NF 77003 .... Prepare room, equipment, Fluoroguide for spine in- 77003 .... Fluoroguide for spine in- 88184 .... Flowcytometry/tc 1 marker L033A ...... Lab Technician ...... NF 88184 .... Clean room/equipment fol- Flowcytometry/tc 1 marker L033A ...... Lab Technician ...... NF 88184 .... Enter data into laboratory Flowcytometry/tc 1 marker L045A ...... Cytotechnologist ...... NF 88184 .... Instrument start-up, quality Flowcytometry/tc 1 marker L045A ...... Cytotechnologist ...... NF 88184 .... Load specimen into flow Flowcytometry/tc 1 marker L045A ...... Cytotechnologist ...... 88184 ....marker NF 1 SL186 Flowcytometry/tc ...... antibody, flow cytometry (each Print out histograms, as-

VerDate Sep<11>2014 22:03 Nov 11, 2016 Jkt 241001 PO 00000 Frm 00215 Fmt 4701 Sfmt 4700 E:\FR\FM\15NOR2.SGM 15NOR2 mstockstill on DSK3G9T082PROD with RULES2 80384 Federal Register / Vol. 81, No. 220 / Tuesday, November 15, 2016 / Rules and Regulations 0.37 ¥ 0.05 ¥ 1.32 ¥ 0.08 ¥ 1.91 ¥ 4.49 ¥ 5.64 ¥ 0.33 ¥ 0.37 ¥ 0.37 ¥ 0.37 ¥ 0.70 ¥ 0.37 ¥ 0.37 ¥ 7.52 ¥ 0.02 ¥ 0.70 ¥ 0.84 ¥ 5.10 costs Direct change ...... nt time to con- Comment form to established policies for non- highly technical equipment. form to established policies for non- highly technical equipment. form to established policies for non- highly technical equipment. form to established policies for non- highly technical equipment. and/or not individually allocable to a particular patient for service. clinical labor task. form with identical labor activity in other codes in the family. clinical labor task. clinical labor task. clinical labor task. clinical labor task. form to established policies for non- highly technical equipment. 2 G1: See preamble text ...... 16 G1: See preamble text ...... 50 G1: See preamble text ...... 80 G1: See preamble text ...... CMS refinement (min or qty) 3 0 1 G1: See preamble text ...... 0.37 2 0 G1: See preamble text ...... 1 0 L2: Clinical labor task redundant with 1 1 0 L2: Clinical labor task redundant with 0 L2: Clinical labor task redundant with 1 1 0 L2: Clinical labor task redundant with 0 L2: Clinical labor task redundant with 1 0 G6: Indirect Practice Expense input 0 1 L3: Refined clinical labor time to con- 0 1 G1: See preamble text ...... 0.37 —Continued 32 96 62 ABLE T RUC (min or qty) or current value recommendation EFINEMENT PE R Labor activity (where applicable) IRECT slides with paperwork to pathologists. performing service. cording logs. Collate slides and paperwork. Deliver to pathologist. preting physician. information system, multiparameter analyses and field data entry, complete quality assurance documentation. slides with paperwork to pathologists. cording logs. Collate slides and paperwork. Deliver to pathologist. slides with paperwork to pathologists. performing service. cording logs. Collate slides and paperwork. Deliver to pathologist. D ULE R NF ...... 1.6 1 G1: See preamble text ...... NF ...... NF ...... NF 108 ...... NF 108 ...... 99 E1: Refined equipment time to con- 142 99 E1: Refined equipment time to con- 142 129 E1: Refined equipment time to con- 129 E1: Refined equipment time to con- INAL 28—CY 2017 F Input code description NF/F test). table, reclining chair). system (computer w-remote camera). table, reclining chair). system (computer w-remote camera). ABLE T code Input L037B ...... Histotechnologist ...... NF L037B ...... Histotechnologist Assemble and deliver ...... L037B ...... NF Histotechnologist ...... Clean Equipment while NF SL135 ...... Complete workload re- stain, hematoxylin ...... NF ...... 32 L042A 16 ...... G1: See preamble text RN/LPN ...... EF031 ...... NF power table, ...... NF Review imaging with inter- ...... 32 31 E1: Refined equipme data. data. data. data. skn. skn. HCPCS code description code HCPCS 88185 .... Flowcytometry/tc add-on .. L033A ...... Lab Technician ...... NF 88185 ....88185 Enter data into laboratory Flowcytometry/tc add-on ...... add-on Flowcytometry/tc .. SL08988321 ...... SL186 ...... lysing reagent (FACS) ...... Microslide consultation antibody, flow cytometry (each ..... NF L037B88321 ...... Histotechnologist ...... Microslide consultation ...... NF L037B ...... 88323 Histotechnologist Assemble and deliver ...... NF Microslide consultation ..... L037B88323 ...... Complete workload re- .... Histotechnologist Microslide consultation ...... 88323 NF .... L037B ...... Microslide consultation ..... Histotechnologist Assemble and deliver ...... L037B ...... NF 88323 Histotechnologist ...... 88325 Clean equipment while NF Microslide consultation ...... Comprehensive review of SL135 ...... Complete workload re- stain, hematoxylin88325 ...... NF Comprehensive review of 88325 ...... Comprehensive review of 88325 .... Comprehensive review of 95812 ....minutes41–60 EEG ...... EF003 ...... 95812 .... bedroom furniture (hospital bed, minutes...... 41–60 EEG EQ017 .....95812 EEG, digital, prolonged testing ....95813 EEG 41–60 minutes ...... EEG over 1 hour L047B ...... EF003 REEGT95813 ...... bedroom furniture NF EEG over 1 hour (hospital bed, ...... EQ01795813 Perform procedure ...... 96933 EEG, EEG over 1 hour digital, ...... prolonged testing Rcm celulr subcelulr img L047B96934 ...... REEGT Rcm celulr subcelulr img ...... NF Perform procedure ......

VerDate Sep<11>2014 22:03 Nov 11, 2016 Jkt 241001 PO 00000 Frm 00216 Fmt 4701 Sfmt 4700 E:\FR\FM\15NOR2.SGM 15NOR2 mstockstill on DSK3G9T082PROD with RULES2 Federal Register / Vol. 81, No. 220 / Tuesday, November 15, 2016 / Rules and Regulations 80385 0.46 1.95 1.17 0.00 0.00 1.17 0.78 0.07 0.89 ¥ 0.78 ¥ 0.37 ¥ 0.84 ¥ 0.42 ¥ 0.02 ¥ 0.37 ¥ 0.84 ¥ 0.42 ¥ 0.03 ¥ 0.42 ¥ 0.84 to con- nt time to con- nt time to con- nt time to conform with identical labor activity in other codes in the family. form with identical labor activity in other codes in the family. form with identical labor activity in other codes in the family. form to established policies for non- highly technical equipment. form to established policies for non- highly technical equipment. clinical labor task not typical; see preamble text. clinical labor task not typical; see preamble text. form to established policies for non- highly technical equipment. form to established policies for non- highly technical equipment. form to established policies for non- highly technical equipment. clinical labor task not typical; see preamble text. clinical labor task not typical; see preamble text. form with other codes in the family. form with other codes in the family. form with identical labor activity in other codes in the family. form with identical labor activity in other codes in the family. form with other codes in the family. 2 1 G1: See preamble text ...... 2 0 G1: See preamble text ...... 0 5 2 L3: Refined clinical labor time to con- 10 5 L3: Refined clinical labor time to con- 8 L3: Refined clinical labor time to con- 2 0 2 L6: Add-on code. Additional time for 1 L6: Add-on code. Additional time for 2 0 2 L6: Add-on code. Additional time for 1 L6: Add-on code. Additional time for 0 3 L3: Refined clinical labor time to con- 10 8 G1: See preamble text ...... and questionnaire reviewed by technologist, order from physician confirmed and exam protocoled by radiologist. monitor pt/set up IV. preting physician. and questionnaire reviewed by technologist, order from physician confirmed and exam protocoled by radiologist. monitor pt/set up IV. preting physician. monitor pt/set up IV. with exam/evaluation, obtain records/measures. prescriptions. medication history, self assessment tools, and fall screening for PT review. medication history, self assessment tools, and fall screening for PT review. NF ...... 32 31 E1: Refined equipment time to con- NF ...... 32 31 E1: Refined equipment time to con- NF ...... 5 10 E11: Refined equipment time to con- tem. tem. primus). EQ168 .....exam light, ...... NF ES056 ...... reflectance confocal imaging sys- ...... L042A ...... RN/LPN ...... NF Patient clinical information 32 L042A ...... RN/LPN ...... NF L042A ...... RN/LPN 31 Prepare and position pt/ ...... E1: Refined equipme EF031 ...... NF power table, ...... NF Review imaging with inter- EQ168 .....exam ...... light, ...... NF ES056 ...... reflectance confocal imaging sys- ...... L042A ...... RN/LPN ...... 32 NF Patient clinical information 32 L042A ...... RN/LPN 31 E1: Refined equipme ...... NF L042A ...... RN/LPN 31 Prepare and position pt/ ...... E1: Refined equipme EF028 ...... NF table, mat, hi-lo, 6 x 8 platform ...EQ219 ..... NF Review imaging with inter- rehab and testing system (BTE EQ243 ...... treadmill ...... L023A ...... NF Physical Therapy Aide ...... NF L039B ...... Physical Therapy Assistant ...... Prepare and position pt/ 13 NF L039B ...... Physical Therapy Assistant Assist physical therapist ...... NF L039B ...... 5 Physical Therapy Assistant Conduct phone calls/call in ...... 20 E11: NF Refined equipment time Obtain/record medical and L039B ...... AssistantTherapy Physical ...... 3 E11: Refined equipment time to con- NF L039B ...... Physical Therapy Assistantsignsvital Obtain ...... NF Obtain/record medical and 3 5 L3: Refined clinical labor time to con- skn. skn. skn. skn. skn. skn. skn. skn. skn. skn. skn. min. min. min. min. min. min. min. min. min. 96934 .... Rcm celulr subcelulr img 96934 .... Rcm celulr subcelulr img 96934 .... Rcm celulr subcelulr img 96934 .... Rcm celulr subcelulr img 96934 .... Rcm celulr subcelulr img 96935 .... Rcm celulr subcelulr img 96935 .... Rcm celulr subcelulr img 96935 .... Rcm celulr subcelulr img 96935 .... Rcm celulr subcelulr img 96935 .... Rcm celulr subcelulr img 96935 .... Rcm celulr subcelulr img 97161 .... Pt eval low complex 20 97161 .... Pt eval low complex 20 97161 .... Pt eval low complex 20 97161 .... Pt eval low complex 20 97161 .... Pt eval low complex 20 97161 .... Pt eval low complex 20 97161 .... Pt eval low complex 20 97161 .... Pt eval low complex 20 97162 .... Pt eval mod complex 30

VerDate Sep<11>2014 22:03 Nov 11, 2016 Jkt 241001 PO 00000 Frm 00217 Fmt 4701 Sfmt 4700 E:\FR\FM\15NOR2.SGM 15NOR2 mstockstill on DSK3G9T082PROD with RULES2 80386 Federal Register / Vol. 81, No. 220 / Tuesday, November 15, 2016 / Rules and Regulations 0.04 0.05 0.43 0.00 0.00 0.00 0.64 0.00 0.78 0.78 0.78 0.43 0.11 ¥ 0.03 ¥ 0.78 ¥ 0.01 ¥ 0.02 ¥ 1.56 ¥ 0.05 ¥ 0.39 ¥ 0.34 ¥ 0.07 ¥ 0.10 ¥ 1.95 costs Direct change - - to con- time to con- Comment form with other codes in the family. form with identical labor activity in other codes in the family. form with other codes in the family. form with other codes in the family. form with other codes in the family. form with identical labor activity in other codes in the family. form with other codes in the family. form with other codes in the family. form with other codes in the family. form with other codes in the family. form with other codes in the family. form with other codes in the family. form with other codes in the family. form with other codes in the family. form with other codes in the family. form with identical labor activity in other codes in the family. form with identical labor activity in other codes in the family. form with identical labor activity in other codes in the family. form with other codes in the family. form with other codes in the family. form with other codes in the family. form with other codes in the family. CMS refinement (min or qty) 5 4 G1: See preamble text ...... 5 7 L3: Refined clinical labor time to con- —Continued 15 10 L3: Refined clinical labor time to con- 12 8 L3: Refined clinical labor time to con- ABLE T RUC (min or qty) or current value recommendation EFINEMENT PE R Labor activity (where applicable) IRECT with exam/evaluation, obtain records/measures. medication history, self assessment tools, and fall screening for PT review. forming procedure (15%). medication history, self assessment tools, and fall screening for PT review. D ULE R NF ...... 5 NF 2 E11: Refined equipment time to con- ...... 6 NF ...... 5 S5: Refined supply quantity to con- NF 0 ...... 8 E11: Refined equipment time to con- 0 10 E11: Refined equipment time to con- NF NF ...... 0 5 8 E11: Refined equipment time to con- 4 E11: Refined equipment time to con- INAL 28—CY 2017 F Input code description NF/F strength. struments, equipment). system (Balance Master). room. system (Balance Master). tremity-hand (Greenleaf). ABLE T code Input EF028 ...... table, mat, hi-lo, 6 x 8 platform ...EQ148 ..... NF kit, hand dexterity, sensory, EQ201 ...... mountedplatform bars, parallel ..EQ243 ..... NF treadmill ...... L039B ...... NF Physical Therapy Assistant ...... NF ...... L039B ...... 30 Physical Therapy Assistant Assist physical therapist ...... NF Obtain/record medical and 5 SM022 ..... 20 sanitizing cloth-wipe (surface, in- E11: Refined equipment time 0 0 E11: Refined equipment time to con EF033 ...... 3 hi-lotreatment, table, E11: Refined equipment time to con- ...... EL002 ...... NF module—kitchen environmental ..EQ068 ...... NF balance assessment-retraining EQ143 ...... ADL kit, ...... EQ151 ..... NF coordinationmotor kit, ...... EQ152 NF ...... sensory kit, ...... 0 ES057 ...... NF environmental module—bath- 10 ES058 ...... vision kit, ...... L039B NF ...... 10 Physical Therapy Assistant E11: Refined equipment time to con- ...... 8 ...... NF 11 L039B E11: Refined equipment time to con ...... 2 AssistantTherapy Physical ...... Assist physician in per- NF 2 L039B ...... 11 AssistantTherapy Physical measurements Obtain ...... E11: Refined equipment time to con- ...... NF L039B ...... 3 0 E11: Refined equipment time to con- Physical Therapy Assistantsignsvital Obtain ...... EF033 ...... NF 3 table, treatment, hi-lo E11: Refined equipment time to con- ...... EL002 ...... Obtain measurements NF ...... module—kitchen environmental ..EQ068 4 ..... 3 NF ...... E11: Refined equipment time to con- balance assessment-retraining EQ117 ...... 3 evaluation system for upper ex- 6 8 L3: Refined clinical labor time to con- 15 5 14 L3: Refined clinical labor time to con- 6 G1: See preamble text 10 ...... E11: Refined equipment 11 E11: Refined equipment time to con - min. min. min. min. min. min. min. min. min. min. min. min. min. min. min. min. min. min. min. min. min. min. min. HCPCS code description code HCPCS 97163 .... Pt eval high complex 45 97163 .... Pt eval high complex 45 97163 .... Pt eval high complex 45 97163 .... Pt eval high complex 45 97163 .... Pt eval high complex 45 97163 .... Pt eval high complex 45 97163 .... Pt eval high complex 45 97164 .... Pt re-eval est plan care .... L039B ...... Physical Therapy Assistant ...... 97165 NF .... Ot eval low complex 20 97165 Obtain/record medical and .... Ot eval low complex 20 97165 .... Ot eval low complex 20 97165 .... Ot eval low complex 20 97165 .... Ot eval low complex 20 97165 .... Ot eval low complex 20 97165 .... Ot eval low complex 20 97165 .... Ot eval low complex 20 97165 .... Ot eval low complex 20 97165 .... Ot eval low complex 20 97165 .... Ot eval low complex 20 97166 .... Ot eval mod complex 30 97167 .... Ot eval high complex 45 97167 .... Ot eval high complex 45 97167 .... Ot eval high complex 45 97167 .... Ot eval high complex 45

VerDate Sep<11>2014 22:03 Nov 11, 2016 Jkt 241001 PO 00000 Frm 00218 Fmt 4701 Sfmt 4700 E:\FR\FM\15NOR2.SGM 15NOR2 mstockstill on DSK3G9T082PROD with RULES2 Federal Register / Vol. 81, No. 220 / Tuesday, November 15, 2016 / Rules and Regulations 80387 3.24 ¥ 0.78 ¥ 0.01 ¥ 0.59 ¥ 0.36 ¥ 0.26 ¥ 2.34 ¥ 0.39 ¥ 38.45 item; see preamble SL201. item; see preamble SL063. form with identical labor activity in other codes in the family. form with other codes in the family. form with other codes in the family. form with other codes in the family. form with other codes in the family. form with identical labor activity in other codes in the family. 2 G1: See preamble text ...... 9 7 L3: Refined clinical labor time to con- 3 ...... 0 48 S8: Supply item replaces another ...... 48 0 S7: Supply item replaced by another forming procedure (15%). NF NF ...... NF ...... 11 5 14 0 E11: Refined equipment time to con- 3 E11: Refined equipment time to con- 10 E11: Refined equipment time to con- ment. primus). room. EQ143 .....ADL kit, ...... EQ185 ..... NF neurobehavioral status instru- EQ219 ...... rehab and testing system (BTE ES057 ...... environmental module — bath- L039B ...... Physical Therapy Assistant ...... NF L039B 15 ...... AssistantTherapy Physical ...... Assist physician in per- NF measurements Obtain ...... 11 E11: Refined equipment time to con- 12 6 L3: Refined clinical labor time to con- min. min. min. min. min. min. 97167 .... Ot eval high complex 45 97167 .... Ot eval high complex 45 97167 .... Ot eval high complex 45 97167 .... Ot eval high complex 45 97167 .... Ot eval high complex 45 97167 .... Ot eval high complex 45 97168 ....G0416 .... Ot re-eval est plan care .... Prostate biopsy, any mthd L039BG0416 ...... SL063 ...... Physical Therapy Assistant Prostate biopsy, any mthd ...... eosin y ...... SL201 NF ...... NF stain, eosin ...... Obtain measurements ...... NF ......

VerDate Sep<11>2014 17:02 Nov 12, 2016 Jkt 241001 PO 00000 Frm 00219 Fmt 4701 Sfmt 4700 E:\FR\FM\15NOR2.SGM 15NOR2 mstockstill on DSK3G9T082PROD with RULES2 80388 Federal Register / Vol. 81, No. 220 / Tuesday, November 15, 2016 / Rules and Regulations

TABLE 29—CY 2017 FINAL RULE NO TABLE 29—CY 2017 FINAL RULE NO TABLE 29—CY 2017 FINAL RULE NO PE REFINEMENT TABLE PE REFINEMENT TABLE—Continued PE REFINEMENT TABLE—Continued

HCPCS Code Short Descriptor HCPCS Code Short Descriptor HCPCS Code Short Descriptor

00740 ...... Anesth upper gi visualize. 36140 ...... Establish access to artery. 43215 ...... Esophagoscopy flex re- 00810 ...... Anesth low intestine scope. 36147 ...... Access av dial grft for eval. move fb. 11730 ...... Removal of nail plate. 36148 ...... Access av dial grft for proc. 43216 ...... Esophagoscopy lesion re- 19298 ...... Place breast rad tube/ 36200 ...... Place catheter in aorta. moval. caths. 36227 ...... Place cath xtrnl carotid. 43217 ...... Esophagoscopy snare les 20245 ...... Bone biopsy excisional. 36228 ...... Place cath intracranial art. remv. 20550 ...... Inj tendon sheath/ligament. 36245 ...... Ins cath abd/l-ext art 1st. 43220 ...... Esophagoscopy balloon 20552 ...... Inj trigger point 1/2 muscl. 36246 ...... Ins cath abd/l-ext art 2nd. <30mm. 20553 ...... Inject trigger points 3/>. 36247 ...... Ins cath abd/l-ext art 3rd. 43226 ...... Esoph endoscopy dilation. 20982 ...... Ablate bone tumor(s) perq. 36248 ...... Ins cath abd/l-ext art addl. 43227 ...... Esophagoscopy control 20983 ...... Ablate bone tumor(s) perq. 36481 ...... Insertion of catheter vein. bleed. 22512 ...... Vertebroplasty addl inject. 36555 ...... Insert non-tunnel cv cath. 43229 ...... Esophagoscopy lesion ab- 22515 ...... Perq vertebral augmenta- 36557 ...... Insert tunneled cv cath. late. tion. 36558 ...... Insert tunneled cv cath. 43231 ...... Esophagoscop ultrasound 22526 ...... Idet single level. 36560 ...... Insert tunneled cv cath. exam. 22527 ...... Idet 1 or more levels. 36561 ...... Insert tunneled cv cath. 43232 ...... Esophagoscopy w/us nee- 22853 ...... Insj biomechanical device. 36563 ...... Insert tunneled cv cath. dle bx. 22854 ...... Insj biomechanical device. 36565 ...... Insert tunneled cv cath. 43235 ...... Egd diagnostic brush wash. 22859 ...... Insj biomechanical device. 36566 ...... Insert tunneled cv cath. 43236 ...... Uppr gi scope w/submuc 22867 ...... Insj stablj dev w/dcmprn. 36568 ...... Insert picc cath. inj. 22868 ...... Insj stablj dev w/dcmprn. 36570 ...... Insert picvad cath. 43239 ...... Egd biopsy single/multiple. 22869 ...... Insj stablj dev w/o dcmprn. 43245 ...... Egd dilate stricture. 22870 ...... Insj stablj dev w/o dcmprn. 36571 ...... Insert picvad cath. 43247 ...... Egd remove foreign body. 28289 ...... Repair hallux rigidus. 36576 ...... Repair tunneled cv cath. 43248 ...... Egd guide wire insertion. 28291 ...... Corrj halux rigdus w/implt. 36578 ...... Replace tunneled cv cath. 43249 ...... Esoph egd dilation <30 28292 ...... Correction of bunion. 36581 ...... Replace tunneled cv cath. mm. 28295 ...... Correction hallux valgus. 36582 ...... Replace tunneled cv cath. 28296 ...... Correction of bunion. 36583 ...... Replace tunneled cv cath. 43250 ...... Egd cautery tumor polyp. 28297 ...... Correction of bunion. 36585 ...... Replace picvad cath. 43251 ...... Egd remove lesion snare. 28298 ...... Correction of bunion. 36590 ...... Removal tunneled cv cath. 43252 ...... Egd optical 28299 ...... Correction of bunion. 36870 ...... Percut thrombect av fistula. endomicroscopy. 31615 ...... Visualization of windpipe. 36907 ...... Balo angiop ctr dialysis 43255 ...... Egd control bleeding any. 31622 ...... Dx bronchoscope/wash. seg. 43270 ...... Egd lesion ablation. 31623 ...... Dx bronchoscope/brush. 36908 ...... Stent plmt ctr dialysis seg. 43284 ...... Laps esophgl sphnctr 31624 ...... Dx bronchoscope/lavage. 36909 ...... Dialysis circuit embolj. agmntj. 31625 ...... Bronchoscopy w/biopsy(s). 37183 ...... Remove hepatic shunt 43285 ...... Rmvl esophgl sphnctr dev. 31626 ...... Bronchoscopy w/markers. (tips). 43450 ...... Dilate esophagus 1/mult 31627 ...... Navigational bronchoscopy. 37185 ...... Prim art m-thrmbc sbsq vsl. pass. 31628 ...... Bronchoscopy/lung bx 37186 ...... Sec art thrombectomy add- 43453 ...... Dilate esophagus. each. on. 44380 ...... Small bowel endoscopy br/ 31629 ...... Bronchoscopy/needle bx 37193 ...... Rem endovas vena cava wa. each. filter. 44381 ...... Small bowel endoscopy br/ 31632 ...... Bronchoscopy/lung bx addl. 37222 ...... Iliac revasc add-on. wa. 31633 ...... Bronchoscopy/needle bx 37223 ...... Iliac revasc w/stent add-on. 44382 ...... Small bowel endoscopy. addl. 37232 ...... Tib/per revasc add-on. 44385 ...... Endoscopy of bowel pouch. 31634 ...... Bronch w/balloon occlu- 37233 ...... Tibper revasc w/ather add- 44386 ...... Endoscopy bowel pouch/ sion. on. biop. 31635 ...... Bronchoscopy w/fb re- 37234 ...... Revsc opn/prq tib/pero 44388 ...... Colonoscopy thru stoma moval. stent. spx. 31645 ...... Bronchoscopy clear air- 37235 ...... Tib/per revasc stnt & ather. 44389 ...... Colonoscopy with biopsy. ways. 37237 ...... Open/perq place stent ea 44390 ...... Colonoscopy for foreign 31646 ...... Bronchoscopy reclear air- add. body. way. 37239 ...... Open/perq place stent ea 44391 ...... Colonoscopy for bleeding. 31652 ...... Bronch ebus samplng 1/2 add. 44392 ...... Colonoscopy & polypec- node. 37247 ...... Trluml balo angiop addl art. tomy. 31653 ...... Bronch ebus samplng 3/ 37249 ...... Trluml balo angiop addl 44394 ...... Colonoscopy w/snare. node. vein. 44401 ...... Colonoscopy with ablation. 31654 ...... Bronch ebus ivntj perph 37252 ...... Intrvasc us noncoronary 44404 ...... Colonoscopy w/injection. les. 1st. 44405 ...... Colonoscopy w/dilation. 32405 ...... Percut bx lung/medi- 37253 ...... Intrvasc us noncoronary 45303 ...... Proctosigmoidoscopy di- astinum. addl. late. 32550 ...... Insert pleural cath. 43200 ...... Esophagoscopy flexible 45305 ...... Proctosigmoidoscopy w/bx. 32553 ...... Ins mark thor for rt perq. brush. 45307 ...... Proctosigmoidoscopy fb. 33340 ...... Perq clsr tcat l atr apndge. 43201 ...... Esoph scope w/submucous 45308 ...... Proctosigmoidoscopy re- 33390 ...... Valvuloplasty aortic valve. inj. moval. 33391 ...... Valvuloplasty aortic valve. 43202 ...... Esophagoscopy flex bi- 45309 ...... Proctosigmoidoscopy re- 35471 ...... Repair arterial blockage. opsy. moval. 35472 ...... Repair arterial blockage. 43206 ...... Esoph optical 45315 ...... Proctosigmoidoscopy re- 35475 ...... Repair arterial blockage. endomicroscopy. moval. 35476 ...... Repair venous blockage. 43213 ...... Esophagoscopy retro bal- 45317 ...... Proctosigmoidoscopy 36010 ...... Place catheter in vein. loon. bleed.

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TABLE 29—CY 2017 FINAL RULE NO TABLE 29—CY 2017 FINAL RULE NO TABLE 29—CY 2017 FINAL RULE NO PE REFINEMENT TABLE—Continued PE REFINEMENT TABLE—Continued PE REFINEMENT TABLE—Continued

HCPCS Code Short Descriptor HCPCS Code Short Descriptor HCPCS Code Short Descriptor

45320 ...... Proctosigmoidoscopy ab- 58561 ...... Hysteroscopy remove 93455 ...... Coronary art/grft angio s&i. late. myoma. 93456 ...... R hrt coronary artery angio. 45332 ...... Sigmoidoscopy w/fb re- 58563 ...... Hysteroscopy ablation. 93457 ...... R hrt art/grft angio. moval. 58674 ...... Laps abltj uterine fibroids. 93458 ...... L hrt artery/ventricle angio. 45333 ...... Sigmoidoscopy & polypec- 61640 ...... Dilate ic vasospasm init. 93459 ...... L hrt art/grft angio. 61641 ...... Dilate ic vasospasm add- tomy. 93460 ...... R&l hrt art/ventricle angio. 45334 ...... Sigmoidoscopy for bleed- on. 93461 ...... R&l hrt art/ventricle angio. ing. 61642 ...... Dilate ic vasospasm add- 93464 ...... Exercise w/hemodynamic 45335 ...... Sigmoidoscopy w/submuc on. meas. inj. 62320 ...... Njx interlaminar crv/thrc. 45338 ...... Sigmoidoscopy w/tumr re- 62322 ...... Njx interlaminar lmbr/sac. 93505 ...... Biopsy of heart lining. move. 62324 ...... Njx interlaminar crv/thrc. 93566 ...... Inject r ventr/atrial angio. 45340 ...... Sig w/tndsc balloon dila- 62326 ...... Njx interlaminar lmbr/sac. 93567 ...... Inject suprvlv aortography. tion. 62380 ...... Ndsc dcmprn 1 ntrspc lum- 93568 ...... Inject pulm art hrt cath. 45346 ...... Sigmoidoscopy w/ablation. bar. 93590 ...... Perq transcath cls mitral. 45350 ...... Sgmdsc w/band ligation. 66720 ...... Destruction ciliary body. 93591 ...... Perq transcath cls aortic. 45378 ...... Diagnostic colonoscopy. 67101 ...... Repair detached retina. 93592 ...... Perq transcath closure 45379 ...... Colonoscopy w/fb removal. 67105 ...... Repair detached retina. each. 45380 ...... Colonoscopy and biopsy. 69300 ...... Revise external ear. 93642 ...... Electrophysiology evalua- 45381 ...... Colonoscopy submucous 76706 ...... Us abdl aorta screen aaa. tion. njx. 77332 ...... Radiation treatment aid(s). 93644 ...... Electrophysiology evalua- 45382 ...... Colonoscopy w/control 77333 ...... Radiation treatment aid(s). tion. bleed. 77334 ...... Radiation treatment aid(s). 95144 ...... Antigen therapy services. 45384 ...... Colonoscopy w/lesion re- 77470 ...... Special radiation treatment. 95165 ...... Antigen therapy services. 77600 ...... Hyperthermia treatment. moval. 95957 ...... EEG digital analysis. 77605 ...... Hyperthermia treatment. 45385 ...... Colonoscopy w/lesion re- 96160 ...... Pt-focused hlth risk assmt. moval. 77610 ...... Hyperthermia treatment. 96161 ...... Caregiver health risk 45386 ...... Colonoscopy w/balloon 77615 ...... Hyperthermia treatment. assmt. dilat. 91110 ...... Gi tract capsule endos- 45388 ...... Colonoscopy w/ablation. copy. 96440 ...... Chemotherapy 45398 ...... Colonoscopy w/band liga- 91111 ...... Esophageal capsule en- intracavitary. tion. doscopy. 96931 ...... Rcm celulr subcelulr img 47000 ...... Needle biopsy of liver. 92132 ...... Cmptr ophth dx img ant skn. 47382 ...... Percut ablate liver rf. segmt. 96932 ...... Rcm celulr subcelulr img 47383 ...... Perq abltj lvr cryoablation. 92133 ...... Cmptr ophth img optic skn. 49411 ...... Ins mark abd/pel for rt nerve. 96936 ...... Rcm celulr subcelulr img perq. 92134 ...... Cptr ophth dx img post skn. 49446 ...... Change g-tube to g-j perc. segmt. 99151 ...... Mod sed same phys/qhp 50200 ...... Renal biopsy perq. 92235 ...... Eye exam with photos. <5 yrs. 50592 ...... Perc rf ablate renal tumor. 92240 ...... Icg angiography. 99152 ...... Mod sed same phys/qhp 5/ 50593 ...... Perc cryo ablate renal tum. 92242 ...... Fluorescein icg yrs. 51702 ...... Insert temp bladder cath. angiography. 99153 ...... Mod sed same phys/qhp 51703 ...... Insert bladder cath com- 92250 ...... Eye exam with photos. ea. plex. 92960 ...... Cardioversion electric ext. 99155 ...... Mod sed oth phys/qhp <5 51720 ...... Treatment of bladder le- 93312 ...... Echo transesophageal. yrs. sion. 93314 ...... Echo transesophageal. 99156 ...... Mod sed oth phys/qhp 5/ 51784 ...... Anal/urinary muscle study. 93451 ...... Right heart cath. yrs. 55700 ...... Biopsy of prostate. 93452 ...... Left hrt cath w/ 99157 ...... Mod sed other phys/qhp 57155 ...... Insert uteri tandem/ovoids. ventrclgrphy. ea. 58559 ...... Hysteroscopy lysis. 93453 ...... R&l hrt cath w/ G0341 ...... Percutaneous islet 58560 ...... Hysteroscopy resect sep- ventriclgrphy. celltrans. tum. 93454 ...... Coronary artery angio s&i.

TABLE 30—CY 2017 FINAL RULE NEW INVOICES TABLE

Invoices received for New Direct PE inputs Estimated non-facility CMS Number of allowed services CPT/HCPCS codes Item name code Average price invoices for HCPCS codes using this item

31551, 31552, 31553, 31554, rhinolaryngoscope, flexible, video, non-chan- ES063 8,000.00 1 541,537 31574, 31575, 31579, neled. 31580, 31584, 31587, 31591, 31592. 31572, 31573, 31576, 31577, rhinolaryngoscope, flexible, video, channeled .. ES064 9,000.00 1 756 31578. 31576, 31577, 31578 ...... Disposable biopsy forceps ...... SD318 26.84 1 574

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TABLE 30—CY 2017 FINAL RULE NEW INVOICES TABLE—Continued

Invoices received for New Direct PE inputs Estimated non-facility CMS Number of allowed services CPT/HCPCS codes Item name code Average price invoices for HCPCS codes using this item

31579 ...... stroboscopy system ...... ES065 16,843.87 1 54,466 31574 ...... Voice Augmentation Gel ...... SJ090 575.00 1 99 36473 ...... Claravein Kit ...... SA122 890.00 1 264 36473, 36474 ...... Sotradecol Sclerosing Agent ...... SH108 110.20 1 528 55700 ...... Biopsy Guide ...... EQ375 7,000.00 0 85,731 58558 ...... Hysteroscopic tissue removal device ...... SF059 629.00 2 2,677 58558 ...... Hysteroscopic fluid management system ...... EQ378 14,698.38 1 2,677 58558 ...... Hysteroscopic resection system (control unit, EQ379 19,772.25 1 2,677 footpiece, handpiece, sheath, and calibration device). 58558 ...... Hysteroscopic fluid management tubing kit ...... SA123 320.00 1 2,677 70540, 70542, 70543; over 400 Professional PACS Workstation ...... ED053 14,616.93 9 32,571,650 additional codes. 77332 ...... knee wedge/foot block system ...... EQ376 3,290.00 1 48,831 77333 ...... Thermoplastic tissue bolus 30X30X0.3cm ...... SD321 23.90 1 3,493 77333 ...... water bath, digital control ...... EP120 2,350.00 1 3,493 77333, 77334 ...... Supine Breast/Lung Board ...... EQ377 5,773.15 1 290,969 77334 ...... Urethane Foaming Agent ...... SL519 53.50 1 287,476 88184, 88185 ...... flow cytometry analytics software ...... EQ380 14,000.00 1 1,680,252 95144, 95165 ...... antigen vial transport envelope ...... SK127 1.50 2 6,464,311 96161 ...... Beck Depression Inventory, Second Edition SK128 2.26 1 1 (BDI–II). 96416 ...... IV infusion pump, ambulatory ...... EQ381 2,384.45 0 116,894 96931, 96932 ...... Imaging Tray ...... SA121 34.75 1 5 96931, 96932 ...... adhesive ruler ...... SK125 9.95 1 5 96931, 96932, 96934, 96935 ... reflectance confocal imaging system ...... ES056 98,500.00 1 9 97166, 97167, 97168 ...... environmental module—bathroom ...... ES057 25,000.00 1 115,107 97166, 97167 ...... kit, vision ...... ES058 410.00 1 86,912 G0202, G0204, G0206 ...... PACS Mammography Workstation ...... ED054 103,616.47 8 2,274,249 G0501 ...... patient lift system ...... EF045 2,824.33 3 15,115,789 G0501 ...... wheelchair accessible scale ...... EF046 875.92 3 15,115,789 G0501 ...... leg positioning system ...... EF047 1,076.50 3 15,115,789 No Codes ...... Chloraprep applicator (26 ml) ...... SJ091 8.48 3 0 No Codes ...... LED Light Source (50W LED) ...... EQ382 1,915.00 1 0

TABLE 31—CY 2017 FINAL RULE EXISTING INVOICES TABLE

Invoices received for Existing Direct PE inputs Estimated non-facility CMS Percent Number of in- allowed services CPT/HCPCS codes Item name code Current price Updated price change voices for HCPCS codes using this item

19030, 19081, room, digital mam- EL013 168,214.00 362,935.00 116 10 2,294,862 19082, 19281, mography. 19282, 19283, 19284, 77053, 77054, G0202, G0204, G0206. 31551, 31552, video system, en- ES031 33,232.50 33,391.00 0 3 1,497,130 31553, 31554, doscopy (proc- 31572, 31573, essor, digital 31574, 31575, capture, monitor, 31576, 31577, printer, cart). 31578, 31579, 31580, 31584, 31587, 31591, 31592, 190+ other codes. 58555, 58562, endoscope, rigid, ES009 4,990.50 6,207.50 24 1 672 58563, 58565. hysteroscopy.

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TABLE 31—CY 2017 FINAL RULE EXISTING INVOICES TABLE—Continued

88323, 88355, stain, eosin ...... SL201 0.04 0.07 55 5 45,393 88380, 88381. 88360, 88361 ...... Antibody Estrogen SL493 3.19 14.00 339 4 216,208 Receptor monoclonal. 91110 ...... kit, capsule endos- SA005 450.00 520.00 16 1 30,464 copy w-application supplies (M2A). 91110, 91111 ...... video system, cap- ES029 17,000.00 12,450.00 ¥27 1 30,586 sule endoscopy (software, computer, monitor, printer). 91111 ...... kit, capsule, ESO, SA094 450.00 472.80 5 1 122 endoscopy w-application supplies (ESO). 91200 ...... Fibroscan with ER101 124,950.00 183,390.00 47 1 6,226 printer. 95145, 95146, antigen, venom ...... SH009 16.67 20.14 21 4 50,772 95148, 95149. 95147, 95148, antigen, venom, tri- SH010 30.22 44.05 46 3 37,955 95149. vespid. 122 codes ...... light source, xenon EQ167 6,723.33 7,000.00 4 1 2,149,616 59 codes ...... fiberscope, flexible, ES020 6,301.93 4,250.00 ¥33 1 581,924 rhinolaryngoscopy.

M. Therapy Caps the upcoming calendar year and (ATRA) (Pub. L. 112–240) and extended rounding to the nearest $10.00. by subsequent legislation, the PFS-rate 1. Outpatient Therapy Caps for CY 2017 Increasing the CY 2016 therapy cap of accrual process is applied to outpatient Section 1833(g) of the Act requires $1,960 by the CY 2017 MEI of 1.2 therapy services furnished by CAHs application of annual per beneficiary percent and rounding to the nearest even though they are paid on a cost limitations on the amount of expenses $10.00 results in a CY 2017 therapy cap basis. As we explained in the CY 2016 that can be considered as incurred amount of $1,980. PFS final rule, we use cost-based rates expenses for outpatient therapy services An exceptions process for the therapy to track each beneficiary’s incurred under Medicare Part B, commonly caps has been in effect since January 1, expenses amounts for the outpatient referred to as ‘‘therapy caps.’’ There is 2006. Originally required by section therapy services furnished by the one therapy cap for outpatient 5107 of the Deficit Reduction Act of Maryland hospitals paid under the occupational therapy (OT) services and 2005 (DRA), which amended section Maryland All-Payer Model, currently another separate therapy cap for 1833(g)(5) of the Act, the exceptions being tested under the authority of physical therapy (PT) and speech- process for the therapy caps has been section 1115A of the Act. After expenses language pathology (SLP) services extended multiple times through incurred for the beneficiary’s outpatient combined. subsequent legislation as described in therapy services for the year have The therapy caps apply to outpatient the CY 2015 PFS final rule with exceeded one or both of the therapy therapy services furnished in all comment period (79 FR 67730) and caps, therapy suppliers and providers settings, including the previously most recently extended by the MACRA. exempted hospital setting (effective Our current authority to provide an use the KX modifier on claims for October 1, 2012), critical access exceptions process for therapy caps subsequent services to request an hospitals (CAHs) (effective January 1, expires on December 31, 2017. exception to the therapy caps. By using 2014), and Maryland hospitals paid CMS tracks each beneficiary’s the KX modifier, the therapist is under the Maryland All-Payer Model incurred expenses annually and counts attesting that the services above the (effective January 1, 2016). them towards the therapy caps by therapy caps are reasonable and The therapy cap amounts under applying the PFS rate for each service necessary and that there is section 1833(g) of the Act are updated less any applicable multiple procedure documentation of medical necessity for each year based on the Medicare payment reduction (MPPR) amount. As the services in the beneficiary’s medical Economic Index (MEI). Specifically, the required by section 1833(g)(6)(B) of the record. Claims for outpatient therapy annual caps are calculated by updating Act, added by section 603(b) of the services over the caps without the KX the previous year’s cap by the MEI for American Taxpayer Relief Act of 2012 modifier are denied.

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Since October 1, 2012, under section when CPT code 99490 is billed alone or other practitioner) supervising the 1833(g)(5)(C) of the Act as amended by with other payable services on a RHC or auxiliary personnel need not be the the Middle Class Tax Relief and Jobs FQHC claim, and the rate is based on same physician (or other practitioner) Creation Act of 2012 (MCTRJCA) (Pub. the PFS national average non-facility upon whose professional service the L. 112–96), we have been required to payment rate. The requirement that RHC incident to service is based, but only the apply a manual medical review process or FQHC services be furnished face-to- supervising physician (or other to therapy claims when a beneficiary’s face was waived for CCM services practitioner) may bill Medicare for incurred expenses for outpatient furnished to a RHC or FQHC patient incident to services. We responded that therapy services exceed a threshold because CCM services are not required due to the differences between amount of $3,700. Just as there are two to be furnished face-to-face. physician offices and RHCs and FQHCs separate therapy caps, there are two Medicare payment for TCM services in their models of care and payment separate thresholds of $3,700, one for furnished by a RHC or FQHC structures, we believe that the direct OT services and one for PT and SLP practitioner was effective January 1, supervision requirement for services services combined; and incurred 2013, consistent with the effective date furnished by auxiliary personnel is expenses are counted towards these of payment for TCM services under the appropriate for RHCs and FQHCs, but thresholds in the same manner as the PFS (77 FR 68978 through 68994; also, that we would consider changing this in caps. Under section 1833(g)(5) of the see CMS-Pub. 100–02, Medicare Benefit future rulemaking if RHCs and FQHCs Act, as amended by section 202(b) of the Policy Manual, chapter 13, section found that requiring direct supervision MACRA, not all claims exceeding the 110.4). presents a barrier to furnishing CCM therapy thresholds are subject to a TCM services are billable only when services. manual medical review process as they furnished within 30 days of the date of Since payment for CCM in RHCs and were before. Instead, since MACRA, we the patient’s discharge from a hospital FQHCs began on January 1, 2016, some are permitted to do a more targeted (including outpatient observation or RHCs and FQHCs have informed us medical review on these claims using partial hospitalization), skilled nursing that, in their view, the direct factors specified in section facility, or community mental health supervision requirement for auxiliary 1833(g)(5)(E)(ii) of the Act as amended center. Communication (direct contact, personnel has limited their ability to by section 202(b) of the MACRA, telephone, or electronic) with the furnish CCM services. Specifically, including targeting those therapy patient or caregiver must commence these RHCs and FQHCs have stated that providers with a high claims denial rate within 2 business days of discharge, and the direct supervision requirement for therapy services or with aberrant a face-to-face visit must occur within 14 prevented them from entering into billing practices compared to their days of discharge for moderate contracts with third party companies to peers. The manual medical review complexity decision making (CPT code provide CCM services, especially during process required under section 99495), or within 7 days of discharge for hours that they were not open, and that 1833(g)(5)(C) of the Act expires at the high complexity decision making (CPT they were unable to meet the CCM same time as the exceptions process for code 99496). The TCM visit is billed on requirements within their current therapy caps, on December 31, 2017. For the day that the TCM visit takes place, staffing and budget constraints. information on the manual medical and only one TCM visit may be paid per To bill for CCM services, RHCs and review process, go to https:// beneficiary for services furnished during FQHCs must ensure that there is access www.cms.gov/Research-Statistics-Data- that 30 day post-discharge period. If the to care management services on a 24 TCM visit occurs on the same day as hour a day, 7 day a week basis. This and-Systems/Monitoring-Programs/ another billable visit, only one visit may includes providing the patient with a Medicare-FFS-Compliance-Programs/ be billed. TCM and CCM cannot be means to make timely contact with RHC Medical-Review/TherapyCap.html billed during the same time period for or FQHC practitioners who have access III. Other Provisions of the Final Rule the same patient. to the patient’s electronic care plan to for PFS In the CY 2016 PFS final rule with address his or her urgent chronic care comment period (80 FR 71087), we needs. The RHC or FQHC must ensure A. Chronic Care Management (CCM) responded to comments requesting that the care plan is available electronically and Transitional Care Management we make an exception to the at all times to anyone within the RHC (TCM) Supervision Requirements in supervision requirements for auxiliary or FQHC who is providing CCM Rural Health Clinics (RHCs) and personnel furnishing CCM and TCM services. Federally Qualified Health Centers services incident to physician services Once the RHC or FQHC practitioner (FQHCs) in RHCs and FQHCs (80 FR 71087). has initiated CCM services and the In the CY 2016 PFS final rule with Auxiliary personnel in RHCs and patient has consented to receiving this comment period (80 FR 71080 through FQHCs furnish services incident to a service, CCM services can be furnished 71088), we finalized policies for RHC or FQHC visit and include nurses, by a RHC or FQHC practitioner, or by payment of CCM services in RHCs and medical assistants, and other clinical auxiliary personnel, as defined in FQHCs. Payment for CCM services in personnel who work under the direct § 410.26(a)(1), which includes nurses, RHCs and FQHCs was effective supervision of a RHC or FQHC medical assistants, and other personnel beginning on January 1, 2016, for RHCs practitioner. The commenters suggested working under physician supervision and FQHCs that furnish a minimum of that the regulatory language be amended who meet the requirements to provide 20 minutes of qualifying CCM services to be consistent with the provision in incident to services. Auxiliary during a calendar month to patients § 410.26(b)(5) for CCM and TCM personnel in RHCs and FQHCs must with multiple (two or more) chronic services under the PFS, which states furnish services under direct conditions that are expected to last at that services and supplies furnished supervision, which requires that a RHC least 12 months or until the death of the incident to CCM and TCM services can or FQHC practitioner be present in the patient, and that would place the be furnished under general supervision RHC or FQHC and immediately patient at significant risk of death, acute of the physician (or other practitioner) available to furnish assistance and exacerbation/decompensation, or when they are provided by clinical staff. direction. The RHC or FQHC functional decline. Payment is made It further specifies that the physician (or practitioner does not need to be present

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in the room when the service is After considering the comments, we market basket uses Medicare cost report furnished. are finalizing this policy to revise (MCR) data submitted by freestanding Although many RHCs and FQHCs § 405.2413(a)(5) and § 405.2415(a)(5) to FQHCs. In the discussion in the CY prefer to furnish CCM and TCM services state that services and supplies 2017 PFS proposed rule (81 FR 46378– utilizing existing personnel, some RHCs furnished incident to CCM and TCM 46386) we provided an overview of the and FQHCs would like to contract with services can be furnished under general market basket and described the a third party to furnish aspects of their supervision of a RHC or FQHC methodologies used to determine the CCM and TCM services, but cannot do practitioner. cost categories, cost weights, and price so because of the direct supervision proxies. In addition, we compared the B. FQHC-Specific Market Basket requirement. Without the ability to growth rates of the proposed FQHC contract with a third party, these RHCs 1. Background market basket to the growth rates of the and FQHCs have stated that they find it Section 10501(i)(3)(A) of the MEI. difficult to meet the CCM requirements Affordable Care Act (Pub. L. 111–148 2. Overview of the FQHC Market Basket for 24 hours a day, 7 days a week access and Pub. L. 111–152) added section to services. The 2013-based FQHC market basket 1834(o) of the Act to establish a is a fixed-weight, Laspeyres-type price To enable RHCs and FQHCs to payment system for the costs of FQHC effectively contract with third parties to index. A Laspeyres price index services under Medicare Part B based on measures the change in price, over time, furnish aspects of CCM and TCM prospectively set rates. In the services, we proposed to revise of the same mix of goods and services Prospective Payment System (PPS) for purchased in the base period. Any § 405.2413(a)(5) and § 405.2415(a)(5) to FQHC Final Rule published in the May state that services and supplies changes in the quantity or mix of goods 2, 2014 Federal Register (79 FR 25436), and services (that is, intensity) furnished incident to CCM and TCM CMS implemented a methodology and purchased over time relative to a base services can be furnished under general payment rates for the FQHC PPS. The period are not measured. supervision of a RHC or FQHC FQHC PPS base payment rate was The index itself is constructed in practitioner. The proposed exception to determined using FQHC cost report and three steps. First, a base period is the direct supervision requirement claims data and was effective for FQHC selected (in this final rule, the base would apply only to auxiliary personnel payments from October 1, 2014, through period is CY 2013), total base period furnishing CCM or TCM incident to December 31, 2015 (implementation costs are estimated for a set of mutually services, and would not apply to any year). The adjusted base payment rate exclusive and exhaustive cost other RHC or FQHC services. The for the implementation year was categories, and the proportion of total proposed revisions for CCM and TCM $158.85 (79 FR 25455). When costs that each cost category represents services and supplies furnished by calculating the FQHC PPS payment, the is calculated. These proportions are RHCs and FQHCs are consistent with base payment rate is multiplied by the called cost weights. Second, each cost § 410.26(b)(5), which allows CCM and FQHC geographic adjustment factor category is matched to an appropriate TCM services and supplies to be (GAF) based on the location of the price or wage variable, referred to as a furnished by clinical staff under general FQHC, and adjusted for new patients or price proxy. These price proxies are supervision when billed under the PFS. when an initial preventive physical derived from publicly available The following is a summary of the examination or annual wellness visit are statistical series that are published on a comments we received on revising the furnished. Beginning on October 1, consistent schedule (preferably at least supervision requirements for RHCs and 2014, FQHCs began to transition to the on a quarterly basis). Finally, the cost FQHCs to allow general supervision for FQHC PPS based on their cost reporting weight for each cost category is auxiliary personnel furnishing CCM or periods. As of January 1, 2016, all multiplied by the established price TCM services. FQHCs are paid under the FQHC PPS. proxy index level. The sum of these Comment: We received 23 comments Section 1834(o)(2)(B)(ii) of the Act products (that is, the cost weights on our proposal to allow services and requires that the payment for the first multiplied by their price levels) for all supplies furnished incident to CCM and year after the implementation year be cost categories yields the composite TCM services to be furnished under increased by the percentage increase in index level of the market basket for the general supervision of a RHC or FQHC the MEI. Therefore, in CY 2016, the given time period. Repeating this step practitioner. All commenters supported FQHC PPS base payment rate was for other periods produces a series of this change. increased by the MEI. The MEI was market basket levels over time. Dividing Response: We appreciate the support based on 2006 data from the American the composite index level of one period for this proposal. Medical Association (AMA) for self- by the composite index level for an Comment: One commenter urged employed physicians and was used in earlier period produces a rate of growth CMS to use the Advisory Panel on the PFS Sustainable Growth Rate (SGR) in the input price index over that Hospital Outpatient Payment to formula to determine the conversion timeframe. determine RHC and FQHC supervision factor for physician service payments. As previously noted, the market levels. (See the CY 2014 PFS final rule (78 FR basket is described as a fixed-weight Response: Auxiliary personnel in 74264) for a complete discussion of the index because it represents the change RHCs and FQHCs work under direct 2006-based MEI). Section in price over time of a constant mix supervision of a RHC or FQHC 1834(o)(2)(B)(ii) of the Act also requires (quantity and intensity) of goods and practitioner (consistent with statutory that beginning in CY 2017, the FQHC services needed to furnish FQHC and regulatory authority), and we PPS base payment rate is to be increased services. The effects on total costs proposed to make an exception for CCM by the percentage increase in a market resulting from changes in the mix of and TCM services because they are the basket of FQHC goods and services, or goods and services purchased only RHC and FQHC services that have if such an index is not available, by the subsequent to the base period are not a non-face-to-face component. We do percentage increase in the MEI. measured. For example, a FQHC hiring not foresee any additional exceptions to For CY 2017, we proposed to create a more nurses to accommodate the needs this policy. 2013-based FQHC market basket. The of patients would increase the volume

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of goods and services purchased by the FQHC since it captures the scope of requirements for provision of these FQHC, but would not be factored into services that FQHCs furnish compared services. FQHC Practitioner the price change measured by a fixed- to the 2006-based MEI. Compensation costs are derived as the weight FQHC market basket. Only when sum of compensation and other costs as 4. Development of Cost Categories and the index is rebased would changes in reported on Worksheet A; columns 1 Cost Weights for the 2013-Based FQHC the quantity and intensity be captured, and 2; lines 1, 2, 3, 6, 7, 13, 14. The with those changes being reflected in Market Basket Medicare cost reports also captures the cost weights. Therefore, we rebase a. Use of Medicare Cost Report Data ‘‘Other’’ compensation costs (the sum of the market baskets periodically so that The 2013-based FQHC market basket costs reported on Worksheet A; columns the cost weights reflect a current mix of consists of eight major cost categories, 1 and 2; lines 9, 10, 11, and 15). We goods and services purchased (FQHC which were derived from the CY 2013 allocated a portion of these inputs) to furnish FQHC services. Medicare cost reports for freestanding compensation costs to FQHC Practitioner compensation by 3. Creating a FQHC Market Basket FQHCs. These categories are FQHC- Practitioner Compensation, Other multiplying this amount by the ratio of In 2015, we began researching the FQHC Practitioner compensation costs possibility of creating a FQHC market Clinical Compensation, Non-Health Compensation, Fringe Benefits, to the sum of FQHC Practitioner basket that would be used in place of compensation costs and Other Clinical the MEI to update the FQHC PPS base Pharmaceuticals, Fixed Capital, Moveable Capital, and an All Other compensation costs. We believe that the payment rate annually. A FQHC market assumption of distributing the costs (Residual) cost category. The All Other basket should reflect the cost structures proportionally is reasonable since there (Residual) cost category reflects the of FQHCs while the MEI reflects the cost is no additional detail on the specific costs not captured in the other seven structures of self-employed physician occupations these compensation costs cost categories. The CY 2013 Medicare offices. At the time of implementation of represent. We also included a cost reports include all FQHCs whose the FQHC PPS, a FQHC market basket proportion of Fringe Benefit costs as cost reporting period began on or after had not been developed, and therefore, described in section III.B.1.a.iv of this January 1, 2013, and prior to or on the law stipulated that the FQHC PPS final rule. base payment rate be updated by the December 31, 2013. We selected CY (2) Other Clinical Compensation: MEI for the first year after 2013 as the base year because the Other Clinical Compensation includes implementation (CY 2016). In Medicare cost reports for that year were any health-related clinical staff who subsequent years, the FQHC PPS base the most recent, complete set of does not fall under the definition of a payment rate should be annually Medicare cost report data available for FQHC practitioner from paragraph (1) updated by a FQHC market basket, if FQHCs at the time of development of (FQHC Practitioner Compensation). available. the cost share weights and proposed Other Clinical Compensation costs are The MEI cost weights were derived 2013-based FQHC market basket. As derived as the sum of compensation and from data collected by the AMA on the stated above, we compared the cost other costs as reported on Worksheet A; Physician Practice Expense Information share weights from the MCR for CY columns 1 and 2; lines 4, 5, and 8. Survey (PPIS), since physicians, unlike 2009 through CY 2013 and the CY 2013 Similar to the FQHC Practitioner other Medicare providers, are not weights were consistent with the compensation, we also allocate a required to complete and submit a weights from prior years. proportion of the ‘‘Other’’ Clinical Medicare Cost Report. FQHCs submit The resulting 2013-based FQHC compensation costs by multiplying this expense data annually on the Medicare market basket cost weights reflect amount by the ratio of Other Clinical Cost Report form CMS–222–92 (OMB Medicare allowable costs. We define Compensation costs to the sum of FQHC NO: 0938–0107), ‘‘Independent Rural Medicare allowable costs for Practitioner Compensation costs and Health Clinic and Freestanding freestanding FQHC facilities as: Other Clinical compensation costs. Federally Qualified Health Center Cost Worksheet A, Columns 1 and 2, cost Given the ambiguity in the costs Report’’; therefore, we were able to centers lines 1 through 51 but excluding reported on these lines, we believe that estimate relative cost weights specific to line 20, which is professional liability the assumption of distributing the costs FQHCs. We define a ‘‘major cost insurance (PLI). We excluded PLI costs proportionally is reasonable since there weight’’ as one calculated using the from the total Medicare allowable costs is no additional detail on the specific Medicare cost reports (for example, because FQHCs that receive section 330 occupations these compensation costs FQHC practitioner compensation). grant funds also are eligible to apply for represent. We also include a proportion However, the Medicare cost report data medical malpractice coverage under of Fringe Benefit costs as described in allows multiple methods for reporting Federally Supported Health Centers section III.B.1.a.iv of this final rule. detailed expenses, either in detailed Assistance Act (FSHCAA) of 1992 (Pub. (3) Non-Health Compensation: Non- cost center lines or more broadly L. 102–501) and FSHCAA of 1995 (Pub. Health Compensation includes reported in general categories of L. 104–73 amending section 224 of the compensation costs for Office Staff, expenses. An alternative data source is Public Health Service Act). Housekeeping & Maintenance, and used to disaggregate further residual Below we summarize how we derive Pharmacy. Non-Health Compensation costs that could not be classified into a the eight major cost category weights. costs are derived as the sum of major cost category directly using only (1) FQHC Practitioner Compensation: compensation costs as reported on the Medicare Cost Report data. We A FQHC practitioner is defined as one Worksheet A; column 1 only for lines 32 estimated the cost weights for each year of the following occupations: and 51; and Worksheet A; both columns 2009 through 2013 and found the cost Physicians, NPs, PAs, CNMs, Clinical 1 and 2 for line 38. We only use the weights from each year to be similar, Psychologist (CPs), and Clinical Social costs from column 1 for housekeeping which provided confidence in the Worker (CSWs). Under certain and maintenance and pharmacy since derived cost weights. conditions, a FQHC visit also may be we believe that there are considerable We believe that the proposed provided by qualified practitioners of costs other than compensation that methodologies for the FQHC market outpatient DSMT and MNT when the could be reported for these categories. basket better reflect the cost structure of FQHC meets the relevant program We use the costs from both column 1

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and column 2 for office salaries (line 38) allocate the Fringe Benefits cost weight proposed to allocate 46 percent of the since only salaries or compensation to the three compensation cost fringe benefits cost weight to the FQHC should be reported on this line. We also categories (FQHC practitioner practitioner cost weight, 14 percent of include a proportion of Fringe Benefit compensation, other clinical the fringe benefits cost weight to the costs as described in section III.B.1.a.iv compensation, and non-health clinical compensation cost weight, and of this final rule. compensation) based on their relative 40 percent of the fringe benefits cost (4) Fringe Benefits: Worksheet A; proportions. The fringe benefits ratio is weight to the non-health compensation columns 1 and 2; line 45 of the equal to the compensation cost weight cost weight. Table 32 shows the three Medicare cost report captures fringe as a percent of the sum of the compensation category cost weights benefits and payroll tax expenses. The compensation cost weights for all three after the fringe benefit cost weight is fringe benefit cost weight are estimated types of workers. These allocation ratios allocated for the 2013-based FQHC as the fringe benefits costs divided by are 46 percent, 14 percent, and 40 market basket. total Medicare allowable costs. We percent, respectively. Therefore, we

TABLE 32—COMPENSATION CATEGORY COST WEIGHTS AFTER FRINGE BENEFITS ALLOCATION

Before fringe After fringe benefits benefits Cost category allocation allocation % %

FQHC Practitioner Compensation ...... 26.8 31.8 Other Clinical Compensation ...... 8.1 9.5 Non-Health Compensation ...... 23.1 27.4 Fringe Benefits (distribute to comp) ...... 10.7 0.0

(5) Pharmaceuticals: Drugs and Although a cost weight for these market basket cost weights. After these biologicals that are not usually self- categories could be obtained directly outliers were removed, we summed the administered, and certain Medicare- from the costs reported in that cost costs for each category across all covered preventive injectable drugs are center’s respective line on the cost remaining FQHCs. We then divided this paid incident to a FQHC visit. report form, some FQHCs reported by the sum of total Medicare allowable Therefore, pharmaceutical costs include significant costs in other (specify), or costs across all remaining FQHCs to the non-compensation costs reported on ‘‘free form,’’ lines which made it obtain a cost weight for the 2013-based Worksheet A, column 2, for the difficult to determine the accuracy of FQHC market basket for the given pharmacy cost center (line 51). We note these costs. For example, some FQHCs category. See Table 33 for the resulting that pharmaceutical costs are not reported costs only in the free form lines cost weights for these major cost included in the MEI since and not in the cost center specific lines, categories that we obtained from the pharmaceutical costs are paid outside of while other FQHCs reported costs in Medicare cost reports. the PFS. both the cost center specific lines and (6) Fixed Capital: Fixed capital costs the free form lines. Since a majority of TABLE 33—MAJOR COST CATEGORIES are equal to the sum of costs for rent, FQHCs used the free form lines, relying AS DERIVED FROM MEDICARE COST interest on mortgage loans, depreciation solely on the costs reported in the cost REPORTS on buildings and fixtures, and property center specific lines for costs could lead tax as reported on Worksheet A; to an inaccurate cost weights in the 2013 FQHC columns 1 and 2; lines 26, 28, 30, and market basket. For example, if a FQHC Cost category weight (%) 33. reported all other healthcare costs in line 21 rather than breaking the (7) Moveable Capital: Moveable healthcare costs into the detailed cost FQHC Practitioner Com- capital costs are equal to the sum of pensation ...... 26.8 centers (lines 17 through 20.50), then costs for depreciation of medical Other Clinical Compensation 8.1 the cost weight for medical supplies equipment, office equipment, and other Non-Health Compensation ... 23.1 could be lower than it should be if we equipment as reported on Worksheet A; Fringe Benefits (distribute to did not allocate the costs reported in the compensation) ...... 10.7 column 1 and 2; lines 19, 31, and 39. free form lines to medical supplies. Fixed Capital ...... 4.5 (8) All Other (Residual): After Section III.B.1.b explains the method Moveable Capital ...... 1.7 estimating the expenses for the seven used to allocate the residual costs to Non Salary Pharmaceuticals 5.1 cost categories listed above, we summed more detailed cost categories. All Other (Residual) ...... 20.1 all remaining costs together for each After we derived costs for the eight Totals may not sum to 100.0% due to FQHC to come up with All Other major cost categories for each FQHC rounding. (Residual) costs. The costs included in using the Medicare cost report data as the All Other (Residual) category previously described, we addressed data b. Derivation of Detailed Cost Categories include all costs reported for medical outliers using the following steps. First, From the All Other (Residual) Cost supplies, transportation, allowable GME we divided the costs for each of the Weight pass through costs, facility insurance, eight categories by total Medicare The All Other Residual cost weight utilities, office supplies, legal, allowable costs for each FQHC. We then was derived from summing all expenses accounting, administrative insurance, removed those FQHCs whose derived reported on the Medicare cost report telephone, housekeeping & cost weights fell in the top and bottom Worksheet A, columns 1 and 2 for maintenance, nondescript healthcare 5 percent of provider specific derived medical supplies (line 17), costs, nondescript facility costs, and cost weights. Five percent is the transportation (line 18), allowable GME nondescript administrative costs. standard trim applied for all CMS pass through costs (line 20.50), facility

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insurance (line 27), utilities (line 29), categories, we used the relative cost based FQHC market basket’s ‘‘All office supplies (line 40), legal (line 41), shares from the 2006-based MEI for nine Other’’ cost category (20.066 percent), accounting (line 42), administrative detailed cost categories: Utilities; yielding a ‘‘final’’ Utilities cost weight insurance (line 43), telephone (line 44), Miscellaneous Office Expenses; of 1.4 percent in the 2013-based FQHC non-compensation housekeeping & Telephone; Postage; Medical market basket (7 percent * 20.1 percent maintenance (line 32, column 2 only), Equipment; Medical Supplies; = 1.4 percent). nondescript healthcare costs (lines 21– Professional, Scientific, & Technical Table 34 shows the cost weight for 23), nondescript facility costs (lines 34– Services; Administrative & Facility each matching category from the 2006- 36), and nondescript administrative Services; and Other Services. For based MEI, the percent each cost costs (lines 46–48). example, the Utilities cost represents 7 category represents of the 2006-baesd To further divide the ‘‘All Other’’ percent of the sum of the 2006-based MEI ‘‘All Other’’ cost weight, and the residual cost weight (20.1 percent) MEI ‘‘All Other’’ cost category weights; resulting proposed 2013-based FQHC estimated from the CY 2013 Medicare therefore, the Utilities cost weight market basket cost weights for detailed cost report data into more detailed cost would represent 7 percent of the 2013- cost categories.

TABLE 34—DETAILED FQHC COST CATEGORY WEIGHTS

Percent of the 2006-based 2006-based 2013-based FQHC Detailed cost categories MEI cost MEI ‘‘All other’’ FQHC detailed weights cost weight cost weights (%) (%) (%)

Total All Other (Residual) ...... 17.976 100.000 20.1 Utilities ...... 1.266 7.0 1.4 Miscellaneous Office Expenses ...... 2.478 13.8 2.8 Telephone ...... 1.501 8.4 1.7 Postage ...... 0.898 5.0 1.0 Medical Equipment ...... 1.978 11.0 2.2 Medical supplies ...... 1.760 9.8 2.0 Professional, Scientific, & Tech. Services ...... 2.592 14.4 2.9 Administrative & Facility Services ...... 3.052 17.0 3.4 Other Services ...... 2.451 13.6 2.7

FQHCs have liberty in how and where printers), miscellaneous chemicals include fees including but not limited certain costs are reported on the (such as soap and hand sanitizer). to, legal, marketing, professional Medicare cost report form CMS–222–92. • Telephone: Includes expenses association memberships, licensure fees, We believe that, given the ambiguity in classified in NAICS 517 journal fees, continuing education. how the data are reported for these (Telecommunications) and NAICS 518 • Administrative & Facility Services: overhead cost centers on the FQHC cost (Internet service providers), and NAICS Includes the expenses for any report form, relying on the relative 515 (Cable and other subscription administrative and facility services shares determined from the MEI is programming). Telephone service, purchased from an outside agency or reasonable. We believe that the revised which is one component of the party and could include fees including FQHC cost report form will allow us to Telecommunications expenses, but not limited to, accounting, billing, better estimate the detailed cost weights accounts for the majority of the office management services, security for these categories directly. We expect expenditures in this cost category. services, transportation services, all FQHCs to report PPS costs on the • Postage: Includes expenses landscaping, or professional car upkeep. new form for cost report periods classified in NAICS 491 (Postal services) • Other Services: Includes other beginning after October 1, 2014. The and NAICS 492 (Courier services). service expenses including, but not following is a description of the types of • Medical Equipment Expenses: limited to, nonresidential maintenance expenses included in the FQHC detailed Includes the expenses related to and repair, machinery repair, janitorial, cost categories derived from the All maintenance contracts, and the leases or and security services. Other (Residual) cost category: rental of medical equipment used in Table 35 shows the cost categories • diagnosis or treatment of patients. It and weights for the 2013-based FQHC Utilities: Includes expenses would also include the expenses for any market basket. The resulting cost classified in the fuel, oil and gas, water medical equipment that was purchased weights include combining the cost and sewage, and electricity industries. in a single year and not financed. weights derived from the Medicare Cost These types of industries are classified • Medical Supplies Expenses: Report Data (shown in Table 33), in NAICS and include NAICS 2211 Includes the expenses related to medical distributing the fringe benefits weight (Electric power generation, supplies such as sterile gloves, needles, across the three compensation cost transmission, and distribution), 2212 bandages, specimen containers, and categories (shown in Table 32), and (Natural gas distribution), and 2213 catheters. We note that the Medical disaggregating the residual cost weight (Water, sewage, and other systems). Supply cost category does not include into detailed cost categories (shown in • Miscellaneous Office Expense: expenses related to pharmaceuticals Table 34). Additionally, we compare the Includes expenses for office expenses (drugs and biologicals). cost weights of the 2013-based FQHC not reported in other categories, • Professional, Scientific, & Technical market basket to the cost weights in the miscellaneous expenses, included but Services: Includes the expenses for any 2006-based MEI, where we have not limited to, paper (such as paper professional services purchased from an grouped the cost weights from the MEI towels), printing (such as toner for outside agency or party and could to align with the FQHC cost categories.

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TABLE 35—PROPOSED FQHC MARKET BASKET AND MEI, COST CATEGORIES, COST WEIGHTS

2013 FQHC 2006 MEI FQHC cost category weight weight MEI cost category (%) (%)

FQHC Market Basket ...... 100.0 100.000 MEI. Total Compensation ...... 68.7 67.419 Total Compensation. FQHC Practitioner Compensation ...... 31.7 50.866 Physician Compensation. Other Clinical Compensation ...... 9.5 6.503 Other Clinical Compensation. Non-health Compensation ...... 27.4 10.050 Non-health Compensation. All Other Products ...... 16.1 14.176 All Other Products. Utilities ...... 1.4 1.266 Utilities. Miscellaneous Office Expenses ...... 2.8 2.478 Miscellaneous Office Expenses. Telephone ...... 1.7 1.501 Telephone. Postage ...... 1.0 0.898 Postage. Medical Equipment ...... 2.2 1.978 Medical Equipment. Medical Supplies ...... 2.0 1.760 Medical Supplies. Professional Liability Insurance ...... — 4.295 Professional Liability Insurance. Pharmaceuticals ...... 5.1 — Pharmaceuticals. All Other Services ...... 9.0 8.095 All Other Services. Professional, Scientific & Technical Services 2.9 2.592 Professional, Scientific & Technical Services. Administrative & Facility Services ...... 3.4 3.052 Administrative & Facility Services. Other Services ...... 2.7 2.451 Other Services. Capital ...... 6.1 10.310 Capital. Fixed Capital ...... 4.5 8.957 Fixed Capital. Moveable Capital ...... 1.7 1.353 Moveable Capital.

Although the overall cost structure of c. Selection of Price Proxies for the measure the rate of change in employee the MEI, the index currently used to 2013-Based FQHC Market Basket wage rates and employer costs for employee benefits per hour worked. update the FQHC PPS base payment, is After establishing the 2013 cost These indexes are fixed-weight indexes similar to the FQHC cost structure, there weights for the FQHC market basket, an and strictly measure the change in wage are a few key differences. First, though appropriate price proxy was selected for rates and employee benefits per hour. total compensation costs in the FQHC each cost category. The price proxies are Appropriately, they are not affected by market basket and the MEI are each chosen from a set of publicly available approximately 67–68 percent of total shifts in employment mix. price indexes that best reflect the rate of We evaluate the price proxies using costs, non-health compensation price change for each cost category in the criteria of reliability, timeliness, accounts for a larger share of the FQHC market basket. All of the availability, and relevance. Reliability compensation costs in the FQHC setting proxies for the 2013-based FQHC market indicates that the index is based on than in the self-employed physician basket are based on indexes published valid statistical methods and has low office. Likewise, physician by the Bureau of Labor Statistics (BLS) sampling variability. Timeliness implies compensation accounts for a larger and are grouped into one of the that the proxy is published regularly, percentage of costs in the MEI than following BLS categories: preferably at least once a quarter. • FQHC practitioner compensation Producer Price Indexes: Producer Availability means that the proxy is accounts for in the FQHC market basket. Price Indexes (PPIs) measure price publicly available. Finally, relevance Second, the FQHC market basket changes for goods sold in markets other means that the proxy is applicable and includes a cost category for than the retail market. PPIs are representative of the cost category pharmaceuticals, while drug costs are preferable price proxies for goods and weight to which it is applied. We excluded from the MEI. Drug costs are services that businesses purchase as believe the PPIs, CPIs, and ECIs selected an expense in the FQHC PPS base inputs. For example, we proposed to use meet these criteria. payment rate since drugs and a PPI for prescription drugs, rather than Table 36 lists all price proxies for the biologicals that are not usually self- the Consumer Price Index (CPI) for 2013-based FQHC market basket. Below prescription drugs, because healthcare administered, and certain Medicare- is a detailed explanation of the price providers generally purchase drugs covered preventive injectable drugs are proxies for each cost category; we note directly from a wholesaler. The PPIs paid incident to a visit while drug costs that many of the proxies for the 2013- measure price changes at the final stage are reimbursed separately under the based FQHC market basket are the same of production. as those used for the 2006-based MEI. PFS. Third, as mentioned previously, • Consumer Price Indexes: CPIs (1) FQHC Practitioner Compensation: PLI expenditures are excluded from the measure change in the prices of final We proposed to use the ECI for Total FQHC market basket since most FQHC’s goods and services bought by the typical Compensation for Private Industry PLI costs are covered under the consumer. Because they may not Workers in Professional and Related) FSHCAA, while in the MEI the PLI costs represent the price encountered by a (BLS series code CIU2010000120000I) to are a significant expense for self- producer, we use CPIs only if an measure price growth of this category. employed physicians. Finally, fixed appropriate PPI is not available, or if the There is no specific ECI for physicians capital expenses, which include costs expenditures are more like those faced and, therefore, similar to the MEI, we such as office rent and depreciation, are by retail consumers than by purchasers proposed to use an index that is based about half of the share in the FQHC of goods at the wholesale level. on professionals that receive advanced market basket as they are in the MEI. • Employment Cost Indexes: training. We note that the 2006-based Employment Cost Indexes (ECIs) MEI has a separate cost category for

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Physician Wages and Salaries and Less Food and Energy avoids double baskets, such as 2010-based Inpatient Physician Benefits. For these cost counting of changes in food and energy Prospective Payment System and 2010- categories, the MEI uses the ECI for prices already captured elsewhere in the based Skilled Nursing Facility market Wages and Salaries and ECI for Benefits market basket. We note the MEI does baskets. for Professional and Related not have a separate cost category for (11) Professional, Scientific, & Occupations. miscellaneous office expenses. Technical Services: We proposed to use (2) Other Clinical Compensation: We (6) Telephone Services: We proposed the ECI for Total Compensation for proposed to use the ECI for Total to use the CPI for Telephone Services Private Industry Workers in Compensation for all Civilian Workers (BLS series code CUUR0000SEED) to Professional, Scientific, and Technical in Health Care and Social Assistance measure the price growth of this cost Services (BLS series code (BLS series code CIU1016200000000I) to category. This is the same price proxy CIU2015400000000I) to measure the measure the price growth of this cost used in the 2006-based MEI. price growth of this cost category. This (7) Postage: We proposed to use the category. This cost category consists of is the same proxy used in the 2006- CPI for Postage (BLS series code compensation costs for Nurses, based MEI. Laboratory Technicians, and all other CUUR0000SEEC01) to measure the price health staff not included in the FQHC growth of this cost category. This is the (12) Administrative & Facility practitioner compensation category. same proxy used in the 2006-based MEI. Services: We proposed to use the ECI Based on the clinical composition of (8) Medical Equipment: We proposed Total Compensation for Private Industry these workers, we believe that the ECI to use the PPI Commodities for Surgical Workers in Office and Administrative for health-related workers is an and Medical Instruments (BLS series Support (BLS series code appropriate proxy to measure code WPU1562) as the price proxy for CIU2010000220000I) to measure the compensation price pressures for these this category. This is the same proxy price growth of this cost category. This workers. The MEI uses the ECI for used in the current 2006-based MEI. is the same price proxy used in the Wages and Salaries and benefits for (9) Medical Supplies: We proposed to 2006-based MEI. Hospitals. use a 50/50 blended index comprised of (13) Other Services: We proposed to (3) Non-health Compensation: We the PPI Commodities for Medical and use the ECI for Total Compensation for proposed to use the ECI for Total Surgical Appliances and Supplies (BLS Private Industry Workers in Service Compensation for Private Industry series code WPU156301) and the CPI–U Occupations (BLS series code Workers in Office and Administrative for Medical Equipment and Supplies CIU2010000300000I) to measure the Support (BLS series code (BLS series code CUUR0000SEMG). The price growth of this cost category. This CIU2010000220000I) to measure the 50/50 blend is used in all market is the same price proxy used in the price growth of this cost category. The baskets where we do not have an 2006-based MEI. accurate split available. We believe Non-health compensation cost weight is (14) Fixed Capital: We proposed to FQHCs purchase the types of supplies predominately attributable to use the PPI Industry for Lessors of contained within these proxies, administrative and facility type Nonresidential Buildings (BLS series including such items as bandages, occupations, as reported in the data code PCU531120531120) to measure the dressings, catheters, intravenous from the Medicare cost reports. We note price growth of this cost category. This equipment, syringes, and other general the MEI has a composite index of four is the same price proxy used in the disposable medical supplies, via price proxies, with the majority of the 2006-based MEI. We believe this is an wholesale purchase, as well as at the composite index accounted for by appropriate proxy since fixed capital retail level. Consequently, we proposed administrative occupations, proxied by expenses in FQHCs should reflect to combine the two aforementioned the ECI for Wages & Salaries of Office inflation for the rental and purchase of indexes to reflect those modes of and Administrative Support (Private). business office space. (4) Utilities: We proposed to use the purchase. This is the same proxy used CPI for Fuel and Utilities (BLS series in the 2006-based MEI. (15) Moveable Capital: We proposed code CUUR0000SAH2) to measure the (10) Pharmaceuticals: We proposed to to use the PPI Commodities for price growth of this cost category. This use the PPI Commodities for Machinery and Equipment (series code is the same proxy used in the 2006- Pharmaceuticals for Human Use, WPU11) to measure the price growth of based MEI. Prescription (BLS series code this cost category as this cost category (5) Miscellaneous Office Expenses: WPUSI07003) to measure the price represents nonmedical moveable We proposed to use the CPI for All growth of this cost category. We note the equipment. This is the same proxy used Items Less Food and Energy (BLS series MEI does not have a separate cost in the 2006-based MEI. code CUUR0000SA0L1E) to measure the category for Pharmaceuticals. This price Table 36 lists the proposed price price growth of this cost category. We proxy is used to measure prices of proxies for each cost category in the believe that using the CPI for All Items Pharmaceuticals in other CMS market proposed FQHC market basket.

TABLE 36—COST CATEGORIES AND PRICE PROXIES FOR THE FQHC MARKET BASKET

Cost category FQHC price proxies

FQHC Practitioner Compensation ...... ECI—for Total Compensation for Private Industry Workers in Profes- sional and Related. Other Clinical Compensation ...... ECI—for Total Compensation for all Civilian Workers in Health Care and Social Assistance. Non-health Compensation ...... ECI—for Total Compensation for Private Industry Workers in Office and Administrative Support. Utilities ...... CPI–U for Fuels and Utilities. Miscellaneous Office Expense ...... CPI–U for All Items Less Food And Energy. Telephone ...... CPI–U for Telephone. Postage ...... CP–U for Postage.

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TABLE 36—COST CATEGORIES AND PRICE PROXIES FOR THE FQHC MARKET BASKET—Continued

Cost category FQHC price proxies

Medical Equipment ...... PPI Commodities for Surgical and Medical Instruments. Medical supplies ...... Blend: PPI Commodities for Medical and Surgical Appliances and Sup- plies and CPI for Medical Equipment and Supplies. Pharmaceuticals ...... PPI Commodities for Pharmaceuticals for Human Use, Prescription. Professional, Scientific, and Technical Services ...... ECI—for Total Compensation for Private Industry Workers in Profes- sional, Scientific, and Technical Services. Administrative & Facility Services ...... ECI—for Total Compensation for Private Industry Workers in Office and Administrative Support. Other Services ...... ECI—for Total compensation for Private industry workers in Service Occupations. Fixed Capital ...... PPI Industry—for Lessors of nonresidential buildings. Moveable Capital ...... PPI Commodities—for Machinery and Equipment.

d. Inclusion of Multi-factor Productivity adjustment. We note that the MEI we proposed to use the most recent in the FQHC Market Basket Technical Panel concluded that a historical estimate of annual MFP as Section 1834(o)(2)(B)(ii) of the Act productivity adjustment is appropriate published by the BLS. Generally, the describes the methods for determining for the MEI given the type of services most recent historical MFP estimate is updates to FQHC PPS payment. After performed in physician’s offices. lagged two years from the payment year. the first year of implementation, the Specifically, the MEI Technical Panel Therefore, we proposed to use the 2015 FQHC PPS base payment rate must be report states that ‘‘The input price MFP as published by BLS in the CY2017 increased by the percentage increase in increases within the MEI are reflected in FQHC market basket update. We note that MFP is derived by the MEI. In subsequent years, the FQHC the price proxies, such as changes in subtracting the contribution of labor and PPS base payment rate shall be wages and benefits. Wages increase, in capital input growth from output increased by the percentage increase in part, due to the ability of workers to growth. Since at the time of the a market basket of FQHC goods and increase the amount of output per unit of input. Absent a productivity proposed rule the 2015 MFP has not services as established through been published by BLS, we rely on a regulations or, if not available, the MEI adjustment in the MEI, physicians would be receiving increased payments projection of MFP. The projection of published in the PFS final rule. MFP is currently produced by IHS The MEI published in the PFS final resulting both from their ability to increase their individual outputs and Global Insight (IGI), a national economic rule has a productivity adjustment. The forecasting firm with which CMS MEI has been adjusted for changes in from the productivity gains already reflected in the wage proxies used in the contracts to forecast the components of productivity since its inception. In the the market basket and MFP. A complete CY 2003 PFS final rule with comment index. The productivity adjustment used in the MEI ensures the description of the MFP projection period (67 FR 80019), we implemented methodology is available at http:// a change in the way the MEI was productivity gains reflected in increased outputs are not double counted, or paid www.cms.gov/Research-Statistics-Data- adjusted to account for changes in and-Systems/Statistics-Trends-and- productivity. In 2012, we convened the for twice. Currently, the productivity adjustment in the MEI is based on Reports/MedicareProgramRatesStats/ MEI Technical Panel to review all MarketBasketResearch.html. aspects of the MEI including and the changes in economy-wide productivity based on the rationale that the price Using IGI’s first quarter 2016 forecast, productivity adjustment. For more the productivity adjustment for CY 2017 information regarding the MEI proxy for physician income reflects changes in economy-wide wages. (the 10-year moving average of MFP for Technical Panel, see the CY 2014 PFS the period ending CY 2015) was final rule with comment period (78 FR Implicitly, this assumes physicians can achieve the same level of productivity projected to be 0.4 percent. If more 74264). The MEI Technical Panel recent data are subsequently available as the average general wage earner.’’ We concluded in Finding 5.1 that ‘‘such an (for example, a more recent estimate of believe that the services performed in adjustment continues to be appropriate. the market basket and MFP adjustment), FQHC facilities are similar to those This adjustment prevents ‘double we would use such data to determine covered by physician visits, and counting’ of the effects of productivity the CY 2017 increase in the FQHC therefore, a productivity adjustment is improvements, which would otherwise market basket in the final rule. be reflected in both (i) the increase in appropriate to avoid double counting of compensation and other input price the effects of productivity 5. CY 2017 Market Basket Update: CY proxies underlying the MEI, and (ii) the improvements in the FQHC market 2017 FQHC Market Basket Update growth in the number of physician basket. Compared to the MEI Update for CY services performed per unit of input We proposed to use the most recent 2017 resources, which results from advances estimate of the 10-year moving average For CY 2017, we proposed to use the in productivity by individual physician of changes in annual private nonfarm 2013-based FQHC market basket practices.’’ business (economy-wide) multifactor increase factor to update the FQHC PPS We proposed to include a productivity (MFP), which is the same base payment rate. Consistent with CMS productivity adjustment similar to the measure of MFP used in the MEI. The practice, we estimated the market basket MEI in the FQHC market basket. We BLS publishes the official measure of update for the FQHC PPS based on the believe that applying a productivity private nonfarm business MFP. (See most recent forecast from IGI. Identical adjustment is appropriate because this http://www.bls.gov/mfp for the to the MEI, we proposed to use the would be consistent with the MEI, published BLS historical MFP data). For update based on the most recent which has an embedded productivity the final FQHC market basket update, historical data available at the time of

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publication of the final rule. For proposed FQHC market basket increase For comparison, the 2006-based MEI example, the final CY 2017 FQHC factor for CY 2017 was 1.7 percent. This was projected to be 1.3 percent in CY update would be based on the four- reflected a 2.1-percent increase of FQHC 2017; this estimate was based on IGI’s quarter moving-average percent change input prices and a 0.4-percent first quarter 2016 forecast (with of the FQHC market basket through the adjustment for productivity. We also historical data through the fourth second quarter of 2016 (based on the proposed that if more recent data are quarter of 2015). Table 37 compares the final rule’s statutory publication subsequently available (for example, a proposed 2013-based FQHC market schedule). more recent estimate of the market basket updates and the proposed 2006- Based on IGI’s first quarter 2016 basket or MFP) we would use such data, based MEI market basket updates for CY forecast with historical data through the to determine the CY 2017 update in the 2017. fourth quarter of 2015, the projected final rule.

TABLE 37—PROPOSED FQHC MARKET BASKET AND MEI, COST CATEGORIES, COST WEIGHTS, MFP, AND CY 2017 UPDATE 1

FQHC cost category CY 2017 update MEI Cost category (percent)

FQHC Market Basket ...... 1.7 1.3 MEI. Productivity adjustment ...... 0.4 0.4 Productivity adjustment. FQHC Market Basket (unadjusted) ...... 2.1 1.7 MEI (unadjusted). Total Compensation ...... 2.1 2.0 Total Compensation. FQHC Practitioner Comp...... 1.9 2.0 Physician Compensation. Other Clinical Compensation ...... 1.9 2.0 Other Clinical Compensation. Non-health Compensation ...... 2.4 2.4 Non-health Compensation. All Other Products ...... 2.6 ¥0.6 All Other Products. Utilities ...... ¥3.9 ¥3.9 Utilities. Miscellaneous Office Expenses ...... 2.0 ¥1.7 Miscellaneous Office Expenses. Telephone ...... 0.4 0.4 Telephone. Postage ...... 0.3 0.3 Postage. Medical Equipment ...... 1.2 1.2 Medical Equipment. Medical Supplies ...... ¥0.4 ¥0.4 Medical Supplies. Professional Liability Insurance ...... ¥0.4 Professional Liability Insurance. Pharmaceuticals ...... 7.8 Pharmaceuticals. All Other Services ...... 2.0 2.0 All Other Services. Professional, Scientific & Technical Services 1.5 1.5 Professional, Scientific & Technical Services. Administrative & Facility Services ...... 2.4 2.4 Administrative & Facility Services. Other Services ...... 1.9 1.9 Other Services. Capital ...... 1.6 1.9 Capital. Fixed Capital ...... 2.1 2.1 Fixed Capital. Moveable Capital ...... 0.1 0.1 Moveable Capital. 1 Based on IGI’s first quarter 2016 forecast.

For CY 2017, the proposed 2013- following is a summary of the comments cost report. Commenters stated that based FQHC market basket update (1.7 we received: CMS finalized and issued a revised percent) is 0.4 percent higher than the Comment: Commenters expressed Medicare FQHC cost report (Form CMS– 2006-based MEI (1.3 percent). The 0.4 their support for the creation of a FQHC- 224–14) required to be submitted by percentage point difference stems specific market basket to update the FQHCs for cost reporting periods under mostly from the inclusion of FQHC PPS base payment rate annually. Medicare’s PPS methodology. The pharmaceuticals in the FQHC market We would note that of the comments commenters stated that the revised basket. This cost category and received none indicated an objection to Medicare FQHC cost report would associated price pressures are not the use of an FQHC market basket provide higher quality data than the included in the MEI. compared to the MEI. Commenters previous cost report (Form CMS–222– stated that the MEI is outdated and does 92). We proposed to update the FQHC PPS not appropriately capture the cost of Response: We appreciate the base payment rate by 1.7 percent for CY services that FQHCs furnish. commenters request to use the most 2017 based on the 2013-based FQHC Response: We appreciate the appropriate and up-to-date data for the market basket. The FQHC market basket commenters support for the creation of development of the FQHC market would more accurately reflect the actual the FQHC-specific market basket. As basket. We agree with the commenters costs and scope of services that FQHCs stated in the proposed rule, we believe that the FQHC market basket should be furnish compared to the 2006-based that the 2013-based FQHC market basket rebased using the costs as reported MEI. We invited public comment on all would more accurately reflect the actual under the PPS, coinciding with data aspects of the FQHC market basket costs and scope of services that FQHCs reported on the revised FQHC cost proposals. furnish compared to the 2006-based report (Form CMS–224–14). The revised 6. Summary of Comments and the MEI. cost report form must be used for all Associated Responses on the Proposed Comment: Many commenters cost reports that begin on or after FQHC Market Basket requested that we rebase the FQHC October 1, 2014, which coincides with market basket at the earliest possible the implementation of the FQHC PPS. We received 12 comments on the opportunity to capture new Medicare We plan to update the FQHC market proposed FQHC market-basket. The cost report data from the revised FQHC basket to reflect FQHC costs paid under

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the PPS when we have complete data FQHC market basket in the future using weight. Rather, we are clarifying and from the revised cost report form and the revised cost report form. correcting that the nondescript can verify that the costs reported are Comment: Commenters requested administrative costs include expenses accurate and reliable. confirmation that compensation costs reported on Worksheet A, lines 46–48. Comment: Many commenters that related to FQHC services furnished by The expenses reported on Worksheet A, supported the creation of the FQHC- certified nurse midwives and qualified lines 54–56 were excluded from the specific market basket recommended practitioners of outpatient diabetes self- total costs for FQHC expenses. We some clarifications and modifications to management training (DSMT) and apologize for the confusion this may the proposed market basket cost-weight medical nutrition therapy (MNT) are have caused and appreciate the methodology. Several commenters included within the ‘‘FQHC Practitioner opportunity to correct this language in recommended that the healthcare staff Compensation’’ cost category. the final rule. costs for ‘‘Visiting Nurse’’ services be Response: There are no specific Comment: Many commenters stated included in the ‘‘FQHC Practitioner identified line items on Worksheet A of that the proposed productivity Compensation’’ cost category rather the FQHC cost report form (CMS–222– adjustment to the FQHC market basket than in the ‘‘Other Clinical 92) for reporting these costs. We believe is not justified and that absent further Compensation’’ cost category, as that costs associated with these services study by CMS of FQHC services, it is proposed. The commenters note that would have been reported in lines 9 premature to apply a productivity Chapter 13 of the Medicare Benefit through 11 or line 15 on Worksheet A. adjustment to the FQHC market basket. Policy Manual includes ‘‘visiting nurse As explained in 81 FR 46379, we The commenters stated that FQHC (RN or LPN)’’ as a type of practitioner allocate a portion of these compensation operations are not mirror images of self- that can render a medically necessary costs to ‘‘FQHC Practitioner employed physician practice operations FQHC visit under certain conditions. Compensation’’ and ‘‘Other Clinical and the argument that the adjustment is Compensation’’ by multiplying the sum Response: As the commenters stated, similar to that used in the MEI to avoid of costs reported on Worksheet A lines the compensation costs associated with double counting of effects of 9 through 11 and 15, by the ratio of productivity improvements is not ‘‘Visiting Nurse’’ services were allocated ‘‘FQHC Practitioner Compensation’’ warranted at this time. to the market basket cost category for costs to the sum of ‘‘FQHC Practitioner Response: We respectfully disagree ‘‘Other Clinical Compensation’’ rather Compensation’’ costs and ‘‘Other that a productivity adjustment to the than the market basket cost category for Clinical Compensation’’ costs. We FQHC market basket is not warranted at ‘‘FQHC Practitioner Compensation.’’ believe that the assumption of this time. As discussed in the proposed Commenters are correct that under distributing the costs proportionally is rule, the productivity adjustment certain circumstances, FQHCs can bill reasonable since there is no additional included in the FQHC market basket is for a visit when an RN or LPN furnishes detail on the specific occupations these based on the 10-year moving average of visiting nurse services to a homebound compensation costs represent. On the changes in annual private nonfarm patient in an area with a shortage of revised FQHC Medicare cost report business (economy-wide) multifactor home health agencies. In this situation (Form CMS–224–14), these costs are productivity. We believe that FQHC only, the RN or LPN would be separately reported on lines 29 and 33 services are similar to those that would considered a FQHC practitioner. All of Worksheet A. Therefore, when we otherwise be provided by a primary care other services furnished by a RN or LPN rebase the FQHC market basket physician, mental health professional, would be considered incident to a visit reflecting the revised FQHC Medicare or other clinical care provider, which and not separately billable. Since most cost report form, we will be able to more have demonstrated the ability to achieve services furnished by nurses in FQHCs directly allocate these costs. productivity gains consistent with the are considered incident to a FQHC visit Comment: Commenters requested overall economy as stated in the and are not separately billable visits, we clarification whether there was an error development of the MEI. Therefore, in believe that it is prudent to keep these in the explanation of the ‘‘nondescript order to avoid the double counting of costs allocated to the cost category administrative costs.’’ Commenters FQHC provider productivity, it is ‘‘Other Clinical Compensation’’ at this stated that the proposed rule had listed necessary to include a productivity time. the expenses reported on lines 54–56 of adjustment to the FQHC market basket, Additionally, only 17 FQHCs reported Worksheet A of the cost report; consistent with inclusion of a costs in line 4 (Visiting Nurse) of however, those particular lines capture productivity adjustment in the MEI that Worksheet A of the cost report, which ‘‘costs other than FQHC’’ rather than is used for physician services. We is approximately 1.4 percent of all ‘‘administrative costs.’’ The commenters believe this rationale justifies the FQHCs that submitted cost reports. Had stated the appropriate lines are 46–48 of inclusion of a productivity adjustment these costs been allocated to ‘‘FQHC Worksheet A for ‘‘nondescript in the FQHC market basket. We will Practitioner Compensation,’’ the administrative costs,’’ and if so, continue to evaluate whether the proposed ‘‘FQHC Practitioner requested that we verify this to be true productivity adjustment in the FQHC Compensation’’ cost share weight would and revise the line number references in market basket (which is based on essentially be unchanged (31.9 percent the final rule language. economy-wide productivity) is the most if we were to include the Visiting Nurse Response: We thank the commenters appropriate measure. Compensation costs in that category for noting that there was an error in the compared to the proposed 31.7 percent). explanation of the ‘‘nondescript 7. Final FQHC Market Basket and Final This small difference, based on a very administrative costs’’ in the proposed CY 2017 Market Basket Update small proportion of FQHC’s who report rule. We would like to clarify that the After considering the public this data, would not impact the growth ‘‘nondescript administrative costs’’ comments, we are finalizing the FQHC rate of the FQHC market basket. Thus, include expenses from lines 46–48 not market basket, as proposed. We believe we believe that changing our proposed lines 54–56. The proposed rule used the that the FQHC market basket, as classification of these expenses is not correct data from the cost report, and proposed, more accurately reflects the necessary at this time. We will consider therefore, no changes are necessary to actual costs and scope of services that this issue when we rebase and revise the the computation of the cost category FQHCs furnish relative to the MEI. We

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did not find any technical reason to from the revised form CMS–224–14. We this adjustment to the FQHC market refine the cost weight methodology are also finalizing our proposal to basket. based on the comments received, but include a productivity adjustment to the Table 38 shows the final 2013-based will consider some of these comments FQHC market basket update, as we did FQHC Market Basket cost categories, in the future when we rebase the market not find any compelling technical cost weights, and price proxies. basket based on FQHC cost report data reason that we should not implement

TABLE 38—FINAL CY 2013-BASED FQHC MARKET BASKET COST CATEGORIES, COST WEIGHTS, AND PRICE PROXIES

2013 Cost FQHC cost category Price proxy weight (%)

FQHC Market Basket ...... 100.0 Total Compensation ...... 68.7 FQHC Practitioner Comp...... ECI—for Total Compensation for Private Industry Workers in Professional and Re- 31.7 lated. Other Clinical Compensation ...... ECI—for Total Compensation for all Civilian Workers in Health Care and Social As- 9.5 sistance. Non-health Compensation ...... ECI—for Total Compensation for Private Industry Workers in Office and Administra- 27.4 tive Support. All Other Products ...... 16.1 Utilities ...... CPI–U for Fuels and Utilities ...... 1.4 Miscellaneous Office Expenses CPI–U for All Items Less Food and Energy ...... 2.8 Telephone ...... CPI–U for Telephone ...... 1.7 Postage ...... CP–U for Postage ...... 1.0 Medical Equipment ...... PPI Commodities for Surgical and Medical Instruments ...... 2.2 Medical Supplies ...... Blend: PPI Commodities for Medical and Surgical Appliances and Supplies and CPI 2.0 for Medical Equipment and Supplies. Pharmaceuticals ...... PPI Commodities for Pharmaceuticals for Human Use, Prescription ...... 5.1 All Other Services ...... 9.0 Professional, Scientific & Tech- ECI—for Total Compensation for Private Industry Workers in Professional, Sci- 2.9 nical Services. entific, and Technical Services. Administrative & Facility Serv- ECI—for Total Compensation for Private Industry Workers in Office and Administra- 3.4 ices. tive Support. Other Services ...... ECI—for Total compensation for Private Industry Workers in Service Occupations .. 2.7 Capital ...... 6.1 Fixed Capital ...... PPI Industry—for Lessors of Nonresidential Buildings ...... 4.5 Moveable Capital ...... PPI Commodities—for Machinery and Equipment ...... 1.7

We also proposed that we would use percent. This reflects a 2.2 percent historical data through the second the most recent data available to increase of FQHC input prices and a 0.4- quarter of 2016. determine the final FQHC market basket percent adjustment for productivity. For Table 39 shows the final 2013-based and MFP update for CY 2017. Based on comparison, the MEI increase factor for FQHC market basket updates compared IGI’s third quarter 2016 forecast with CY 2017 is 1.2 percent (a 1.6 percent to the proposed 2013-based FQHC historical data through the second MEI update and a 0.4 percent MFP market basket updates for CY 2017. quarter of 2016, the final FQHC market adjustment); these updates reflect the basket increase factor for CY 2017 is 1.8 most historical data available, with

TABLE 39—FQHC MARKET BASKET FINAL CY 2017 UPDATE OF ALL COST CATEGORIES

CY 2017 Final CY 2017 Pro- FQHC Cost category update* posed update (%) (%)

FQHC Market Basket ...... 1.8 1.7 Productivity adjustment ...... 0.4 0.4 FQHC Market Basket (unadjusted) ...... 2.2 2.1 Total Compensation ...... 2.0 2.1 FQHC Practitioner Compensation ...... 1.6 1.9 Other Clinical Compensation ...... 1.8 1.9 Non-health Compensation ...... 2.5 2.4 All Other Products ...... 3.1 2.6 Utilities ...... ¥2.5 ¥3.9 Miscellaneous Office Expenses ...... 2.1 2.0 Telephone ...... ¥0.1 0.4 Postage ...... 0.5 0.3 Medical Equipment ...... 1.6 1.2 Medical Supplies ...... ¥0.6 ¥0.4 Professional Liability Insurance ...... Pharmaceuticals ...... 8.4 7.8 All Other Services ...... 2.1 2.0 Professional, Scientific & Technical Services ...... 1.5 1.5 Administrative & Facility Services ...... 2.5 2.4

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TABLE 39—FQHC MARKET BASKET FINAL CY 2017 UPDATE OF ALL COST CATEGORIES—Continued

CY 2017 Final CY 2017 Pro- FQHC Cost category update* posed update (%) (%)

Other Services ...... 2.1 1.9 Capital ...... 1.5 1.6 Fixed Capital ...... 2.0 2.1 Moveable Capital ...... 0.1 0.1 * Based on historical data through the 2nd quarter 2016. For the productivity adjustment, the 10-year moving average percent change adjustment for CY 2017 is 0.4 percent, which is based on the most historical data available from BLS at the time of the final rule, and reflects annual MFP estimates through 2015.

C. Appropriate Use Criteria for workflow. CDSMs are the electronic CDSM that is external to a provider’s Advanced Diagnostic Imaging Services portals through which clinicians would primary user interface could utilize an Section 218(b) of the PAMA amended access the AUC during the patient application program interface (API), a workup. While CDSMs can be set of protocols and tools specifying Title XVIII of the Act to add section standalone applications that require how software components should 1834(q) of the Act directing us to direct entry of patient information, they interact, to pull relevant information establish a program to promote the use may be more effective when they into the decision support application of appropriate use criteria (AUC) for automatically incorporate information and provide support back to the primary advanced diagnostic imaging services. such as specific patient characteristics, interface. It could also provide decision The CY 2016 PFS final rule with laboratory results, and lists of co-morbid support, based on the pulled EHR data, comment period addressed the initial diseases from Electronic Health Records via a separate interface. By adhering to component of the new Medicare AUC (EHRs) and other sources. Ideally, common interoperability standards, program, specifying applicable AUC. In practitioners would interact directly such as the national standards advanced that rule we established evidence-based with the CDSM through their primary through certified health IT (see 2015 process and transparency requirements user interface, thus minimizing edition of certification criteria available for the development of AUC, defined interruption to the clinical workflow. in the Federal Register (80 FR 62601) provider-led entities (PLEs) and Consistent with definitions of CDSM and described in the Interoperability established the process by which PLEs by the Agency for Healthcare Research Standards Advisory at https:// may become qualified to develop, and Quality (AHRQ) (http:// www.healthit.gov/standards-advisory), modify or endorse AUC. The first list of www.ahrq.gov/professionals/prevention- CDSMs could both ensure integration of qualified PLEs were posted on the CMS chronic-care/decision/clinical/ patient-specific data from EHRs, and Web site at the end of June 2016 at index.html), and the Office of the allow clinicians to optimize the time which time their AUC libraries became National Coordinator for Health spent using the tool. specified AUC for purposes of section Information Technology (ONC) (https:// Second, the ideal AUC is an evidence- 1834(q)(2)(A) of the Act. www.healthit.gov/policy-researchers- based guide that starts with a patient’s This rule proposed requirements and implementers/clinical-decision-support- specific clinical condition or processes for specification of qualified cds), within Health IT applications, a presentation (symptoms) and assists the clinical decision support mechanisms CDSM is a functionality that provides clinician in the overall patient workup, (CDSMs) under the Medicare AUC persons involved in care processes with treatment, and follow-up. Imaging program; the initial list of priority general and person-specific information, would appear as key nodes within the clinical areas; and exceptions to the intelligently filtered and organized, at clinical management decision tree. requirement that ordering professionals appropriate times, to enhance health Other options outside of certified EHR consult specified applicable AUC when and health care. technology exist to access AUC through ordering applicable imaging services. CDSMs. Stand-alone, internet-based 2. Previous CDSM Experience 1. Background CDSMs are available and, although they In the CY 2016 PFS final rule with will not interact with EHR data, can AUC present information in a manner comment period, we included a nonetheless search for and present AUC that links: A specific clinical condition discussion of the Medicare Imaging relevant to a patient’s presenting or presentation; one or more services; Demonstration (MID), which was symptoms or condition. and, an assessment of the required by section 135(b) of the In communicating an appropriateness appropriateness of the service(s). For MIPPA, in addition to independent rating to the ordering practitioner, some purposes of this program, AUC are a set experiences of implementing AUC by CDSMs provide a scale with numeric or library of individual appropriate use several healthcare systems and ratings, some output a red, yellow, or criteria. Each individual criterion is an academic medical centers. Two key green light while others provide a evidence-based guideline for a aspects of that discussion remain dichotomous yes or no. At this time, we particular clinical scenario. Each relevant to the CDSM component of this do not believe there is one correct scenario in turn starts with a patient’s program. First, AUC, and the CDSMs approach to communicating the level of presenting symptoms and/or condition. through which clinicians access AUC, appropriateness to the ordering Evidence-based AUC for imaging can must be integrated into the clinical professional. However, section assist clinicians in selecting the imaging workflow and facilitate, not obstruct, 1834(q)(4)(B) of the Act requires that study that is most likely to improve evidence-based care delivery. For information be reported on the claim health outcomes for patients based on instance, a CDSM may be fully form as to whether the service would or their individual clinical presentation. integrated with or part of a provider’s would not adhere to the specified AUC AUC need to be integrated as Certified EHR system, partially consulted through a particular CDSM, or seamlessly as possible into the clinical integrated, or entirely outside of it. A whether the AUC was not applicable to

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the service. We requested feedback from AUC (as some PLEs have large libraries 2016 and will not have specified or commenters regarding how of AUC) would become specified across published the list of qualified CDSMs by appropriateness ratings provided by clinical conditions and advanced January 1, 2017; therefore, ordering CDSMs could be interpreted and imaging technologies, we believe this professionals will not be required to recorded for the purposes of this rapid and comprehensive roll out of consult CDSMs, and furnishing program. There are different views specified AUC should be balanced with professionals will not be able to report about the comprehensiveness of AUC a more focused approach when information on the consultation, by this that should be accessible within identifying outlier ordering date. CDSMs. Some stakeholders believe that professionals. We believe this will a. Establishment of AUC the CDSM should contain as provide an opportunity for physicians comprehensive a collection of AUC as and practitioners to become familiar In the CY 2016 PFS final rule with possible, incorporating individual with AUC in identified priority clinical comment period, we addressed the first criteria from across all specified AUC areas prior to Medicare claims for those component under section 1834(q)(2) of libraries. The intent would be for services being part of the input for the Act—the requirements and process ordering professionals to avoid the calculating outlier ordering for establishment and specification of frustration, experienced and voiced by professionals. applicable AUC, along with relevant many clinicians participating in the As we describe earlier, CDSMs are the aspects of the definitions under section MID, of spending time navigating the access point for ordering professionals 1834(q)(1) of the Act. This included CDSM only to find that no criterion for to consult AUC. We believe the defining the term PLE and finalizing their patient’s specific clinical condition combination of the comprehensive and requirements for the rigorous, evidence- exists. focused approaches should be applied based process by which a PLE would Other stakeholders believe, based on to CDSM requirements as we consider a develop AUC, upon which qualification decades of experience rolling out AUC minimum floor of AUC that must be is based, as provided in section in the context of robust quality made available to ordering professionals 1834(q)(2)(B) of the Act and in the CY improvement programs that it is best to through qualified CDSMs. AUC that 2016 PFS final rule with comment start with a CDSM that contains AUC for reasonably address the entire clinical period. Using this process, once a PLE a few clinical areas where impact is scope of priority clinical areas could is qualified by CMS, the AUC that are large and evidence is strong. This would establish a minimum floor of AUC to be developed, modified or endorsed by the ensure that quality AUC are developed, included in qualified CDSMs, and the qualified PLE are considered to be and that clinicians and entire care teams number of priority clinical areas could specified applicable AUC under section could fully understand the AUC they be expanded through annual rulemaking 1834(q)(2)(A) of the Act. We defined the are using, including when they do not and in consultation with physicians and term PLE to include national apply to a particular patient. other stakeholders. This allows priority professional medical societies, health As we stated in the CY 2016 PFS final clinical areas to roll out judiciously, and systems, hospitals, clinical practices rule with comment period, we believe build over time. and collaborations of such entities such there is merit to both approaches, and as the High Value Healthcare it has been suggested to us that the best 4. Statutory Authority Collaborative or the National approach may depend on the particular Section 218(b) of the PAMA added a Comprehensive Cancer Network. care setting. The second, ‘‘focused’’ new section 1834(q) of the Act entitled, Qualified PLEs may collaborate with approach may work better for a large ‘‘Recognizing Appropriate Use Criteria third parties that they believe add value health system that produces and uses its for Certain Imaging Services,’’ which to their development of AUC, provided own AUC. The first, ‘‘comprehensive’’ directs the Secretary to establish a new such collaboration is transparent. We approach may in turn work better for a program to promote the use of AUC. expect qualified PLEs to have sufficient smaller practice with broad image Section 1834(q)(3)(A) of the Act requires infrastructure, resources, and the ordering patterns and fewer resources the Secretary to specify qualified relevant experience to develop and that wants to simply adopt and start CDSMs that could be used by ordering maintain AUC according to the rigorous, using a complete AUC system professionals to consult with specified transparent, and evidence-based developed elsewhere. We believe a applicable AUC for applicable imaging processes detailed in the CY 2016 PFS successful program would allow services. final rule with comment period. flexibility, and under section 1834(q) of A timeline and process was 5. Discussion of Statutory Requirements the Act, we foresee a number of sets of established for PLEs to apply to become AUC developed by different PLEs, and There are four major components of qualified and the first list of qualified an array of CDSMs from which the AUC program under section 1834(q) PLEs was published at https:// clinicians may choose. of the Act, each with its own www.cms.gov/Medicare/Quality- implementation date: (1) Establishment Initiatives-Patient-Assessment- 3. Priority Clinical Areas of AUC by November 15, 2015 (section Instruments/Appropriate-Use-Criteria- We established in the CY 2016 PFS 1834(q)(2)); (2) identification of Program/index.html. final rule with comment period that we mechanisms for consultation with AUC would identify priority clinical areas by April 1, 2016 (section 1834(q)(3)); (3) b. Mechanism for AUC Consultation through rulemaking, and that these may AUC consultation by ordering The second major component of the be used in the determination of outlier professionals and reporting on AUC Medicare AUC program is the ordering professionals (a future phase of consultation by furnishing professionals specification of qualified CDSMs that the Medicare AUC program). The by January 1, 2017 (section 1834(q)(4)); could be used by ordering professionals concept of priority clinical areas allows and (4) annual identification of outlier for consultation with specified us to implement an AUC program that ordering professionals for services applicable AUC under section combines the focused and furnished after January 1, 2017 (section 1834(q)(3) of the Act. We envision a comprehensive approaches to 1834(q)(5)). As we will discuss later in CDSM as an interactive tool that implementation discussed above. this preamble, we did not identify communicates AUC information to the Although potentially large volumes of mechanisms for consultation by April 1, user. Information regarding the clinical

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presentation of the patient would be As we explained in the CY 2016 PFS applicable imaging service is usually incorporated into the CDSM from proposed rule and final rule with not the same professional who bills another health IT system or through comment period, implementation of Medicare for that service when data entry by the ordering professional. many aspects of the amendments made furnished. Section 1834(q)(4)(C) of the At a minimum, the tool would provide by section 218(b) of the PAMA requires Act provides for certain exceptions to immediate feedback to the ordering consultation with physicians, the AUC consultation and reporting professional on the appropriateness of practitioners, and other stakeholders, requirements including in the case of one or more imaging services. Ideally, and notice and comment rulemaking. certain emergency services, inpatient CDSMs would be integrated within or We continue to believe the PFS calendar services paid under Medicare Part A, seamlessly interoperable with existing year rulemaking process is the most and ordering professionals who obtain health IT systems and would appropriate and administratively an exception due to a significant automatically receive patient data from feasible implementation vehicle. Given hardship. Section 1834(q)(4)(D) of the the EHR or through an API or other the timing of the PFS rulemaking Act specifies that the applicable connection. Such integration would process, we were not able to include payment systems for the AUC minimize burden on practitioners and proposals in the PFS proposed rule to consultation and reporting requirements avoid duplicate documentation. Also begin implementation in the same year are the PFS, hospital outpatient useful to clinicians would be the ability the PAMA was enacted, as we would prospective payment system, and the to switch between CDSMs that can have had to interpret and analyze the ambulatory surgical center payment interoperate based on common new statutory language, and develop systems. standards. proposed plans for implementation in Since a list of qualified CDSMs is not Section 1834(q)(3)(A) of the Act states under one month. As we did prior to the yet available and will not be available that the Secretary must specify qualified CY 2016 PFS proposed rule when we by January 1, 2017, we will not require CDSMs in consultation with physicians, met extensively with stakeholders to ordering professionals to meet this practitioners, health care technology gain insight and hear their comments requirement by that date. and concerns about the AUC program, experts, and other stakeholders. This d. Identification of Outliers paragraph authorizes the Secretary to we used the time prior to the CY 2017 specify mechanisms that could include: PFS proposed rule to meet with many The fourth component of the AUC CDS modules within certified EHR of the same stakeholders but also a new program is in section 1834(q)(5) of the technology; private sector CDSMs that group of stakeholders specifically Act, Identification of Outlier Ordering are independent of certified EHR related to CDSMs. In addition, we are Professionals. The identification of technology; and a CDSM established by continuing our stepwise approach to outlier ordering professionals under this the Secretary. The Secretary did not implementing this AUC program. The paragraph facilitates a prior propose to establish a CDSM at this first phase of the AUC program authorization requirement for outlier time. (specifying AUC including defining professionals beginning January 1, 2020, what AUC are and specifying the as specified under section 1834(q)(6) of All CDSMs must meet the process for developing them) was the Act. Although we did not propose requirements under section accomplished through last year’s CY to implement these sections in the CY 1834(q)(3)(B) of the Act, which specifies 2016 PFS final rule with comment 2017 PFS proposed rule, we proposed that a mechanism must: Make available period. For this second phase, we use below a list of priority clinical areas to the ordering professional applicable the CY 2017 PFS rulemaking process as which may serve as part of the basis for AUC and the documentation supporting the vehicle to establish requirements for identifying outlier ordering the appropriateness of the applicable CDSMs, and the process to specify professionals. imaging service that is ordered; where qualified CDSMs, in a transparent there is more than one applicable manner that allows for stakeholder and 6. Proposals for Implementation appropriate use criterion specified for public involvement. Therefore, the final We proposed to amend our an applicable imaging service, indicate CDSM requirements and process for regulations at § 414.94, ‘‘Appropriate the criteria it uses for the service; CDSMs to become qualified are Use Criteria for Certain Imaging determine the extent to which an included in this CY 2017 PFS final rule. Services.’’ applicable imaging service that is ordered is consistent with the c. AUC Consultation and Reporting a. Definitions applicable AUC; generate and provide to The third major component of the In § 414.94(b), we proposed to codify the ordering professional AUC program is in section 1834(q)(4) of and add language to clarify some of the documentation to demonstrate that the the Act, Consultation with Applicable definitions provided in section 1834(q) qualified CDSM was consulted by the Appropriate Use Criteria. This section of the Act, as well as define terms that ordering professional; be updated on a establishes, beginning January 1, 2017, were not defined in statute but for timely basis to reflect revisions to the the requirement for an ordering which a definition would be helpful for specification of applicable AUC; meet professional to consult with a qualified program implementation. In this applicable privacy and security CDSM when ordering an applicable section, we provide a description of the standards; and perform such other imaging service that would be furnished terms we proposed to codify to facilitate functions as specified by the Secretary in an applicable setting and paid for understanding and encouraged public (which may include a requirement to under an applicable payment system; comment on the AUC program. provide aggregate feedback to the and for the furnishing professional to We proposed to define CDSM under ordering professional). Section include on the Medicare claim § 414.94(b) as an interactive, electronic 1834(q)(3)(C) of the Act specifies that information about the ordering tool for use by clinicians that the Secretary must publish an initial list professional’s consultation with a communicates AUC information to the of specified mechanisms no later than qualified CDSM. The statute user and assists them in making the April 1, 2016, and that the Secretary distinguishes between the ordering and most appropriate treatment decision for must identify on an annual basis the list furnishing professional, recognizing that a patient’s specific clinical condition. A of specified qualified CDSMs. the professional who orders an CDSM would incorporate specified

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applicable AUC sets from which an After considering the comments, we codes to find others that would ordering professional could select. A have made no changes to the definitions plausibly fit into each clinical grouping. CDSM may be a module within or and are finalizing the language at This process required subjective clinical available through certified EHR § 414.94(b) as proposed. judgment on whether a particular ICD– technology (as defined in section 9 code should be included in a given b. Priority Clinical Areas 1848(o)(4) of the Act) or private sector clinical group. The top eight clinical mechanisms independent from certified We proposed to establish a new groupings (by volume of procedures) are EHR technology. If within or available § 414.94(e)(5) to set forth the initial list what we proposed as the initial list of through certified EHR technology, a of priority clinical areas. priority clinical areas. The eight clinical qualified CDSM would incorporate To compile this proposed list, we areas account for roughly 40 percent of relevant patient-specific information performed an analysis of Medicare part B advanced diagnostic imaging into the assessment of the claims data using the CMS Chronic services paid for by Medicare in 2014. appropriateness of an applicable Conditions Data Warehouse (CCW) as We are aware that some stakeholders imaging service. the primary data source. The CCW have suggested beginning the AUC As prescribed in section 1834(q) of contains 100 percent of Medicare claims program with no more than five priority the Act and § 414.94(b) of our for beneficiaries who are enrolled in the clinical areas while others have regulations, the Medicare AUC program fee-for-service (FFS) program. Data were suggested a far greater number. We imposes requirements only for derived from the CCW’s 2014 Part B believed the proposed eight priority applicable imaging services furnished in non-institutional claim line file, which clinical areas strike a reasonable balance applicable settings. Further, as specified includes Part B services furnished that allows us to focus on a significant in section 1834(q)(4)(D) of the Act, we during CY 2014. This is the main file range and volume of advanced proposed to amend our regulation at containing final action claims data for diagnostic imaging services. § 414.94(b) to state that the applicable non-institutional health care providers, We also considered extracting payment systems for the Medicare AUC including physicians, physician pulmonary embolism as a separate program are the PFS under section assistants, clinical social workers, nurse priority clinical area from the chest pain 1848(b) of the Act, the prospective practitioners, independent clinical grouping based on stakeholder payment system for hospital outpatient laboratories, and freestanding consultation and feedback. However, we department services under section ambulatory surgical centers. The Part B decided not to identify pulmonary 1833(t) of the Act, and the ambulatory non-institutional claim line file contains surgical center payment systems under the individual line level information embolism separately, but asked for section 1833(i) of the Act. Applicable from the claim and includes Healthcare public comment on whether pulmonary payment systems are relevant to Common Procedure Coding System embolism should be included as a implementation of section 1834(q)(4)(B) (HCPCS) code(s), diagnosis code(s) stand-alone priority clinical area. Based of the Act, entitled ‘‘Reporting by using the International Classification of on our consultations with physicians, Furnishing Professionals.’’ Diseases, Ninth Revision (ICD–9), practitioners and other stakeholders, as We remind readers that in PFS service dates, and Medicare payment required by section 1834(q)(3)(A) of the rulemaking for CY 2016 we defined amount. A publicly available version of Act, we attempted to be inclusive when applicable imaging service in this dataset can be downloaded from the grouping ICD–9 codes into cohesive § 414.94(b) as an advanced diagnostic CMS Web site at https://www.cms.gov/ clinical areas. As an example of how we imaging service as defined in Medicare/Quality-Initiatives-Patient- derived the priority clinical area for low 1834(e)(1)(B) of the Act for which the Assessment-Instruments/Appropriate- back pain, we grouped together 10 ICD– Secretary determines (i) One or more Use-Criteria-Program/index.html. We 9 codes, incorporating six from the top applicable appropriate use criteria encouraged stakeholders to review this 135 and four from the manual search of apply; (ii) There are one or more dataset as a source that might help all ICD–9 codes. Included in this qualified clinical decision support inform public comments related to the grouping are the ICD–9 codes for mechanisms listed; and (iii) One or proposed priority clinical areas. displacement of lumbar intervertebral more of such mechanisms is available In the CY 2016 PFS final rule with disc without myelopathy (722.10), free of charge. comment period, we stated that when degeneration of lumbar of lumbosacral The following is a summary of the identifying priority clinical areas we intervertebral disc (722.52), comments we received on the may consider factors such as incidence intervertebral disc disorder with definitions for CDSM and applicable and prevalence of disease, the volume myelopathy lumbar region (722.73), payment system. and variability of utilization of imaging post-laminectomy syndrome of lumbar Comment: Most comments that services, the strength of evidence for region (722.83), lumbago (724.2), addressed the definitions supported our their use, and applicability of the sciatica (724.3), thoracic or lumbosacral proposals. One commenter requested clinical area to the Medicare population neuritis or radiculitis unspecified that in the definition of CDSM, CMS and to a variety of care settings. (724.4), spinal stenosis, lumbar region, specify that it is a tool for ‘‘ordering Using the 2014 Medicare claims data without neurogenic claudication clinicians.’’ referenced above, we ranked ICD–9 (724.02), lumbosacral spondylosis Response: We disagree that the codes by the frequency with which they without myelopathy (721.3), and regulatory definition of CDSM should were used as the primary indication for spondylosis with myelopathy lumbar specify exactly who can use a CDSM specific imaging procedures, which in region (721.42) which resulted in and believe it should continue to focus turn were identified by the volume of 1,883,617 services. To see all of the on the function and purpose of the tool. individual Current Procedural priority clinical area groupings of We would not want the definition to Terminology (CPT) codes for which diagnosis codes, a table is available on restrict use to one type of user; however, payments were made in 2014. We the CMS Web site at https:// we expect that the ordering professional extracted the top 135 ICD–9 codes from www.cms.gov/Medicare/Quality- would consult the tool. We appreciate this list and formed clinically-related Initiatives-Patient-Assessment- commenters’ general support of the categories. Next, we searched manually Instruments/Appropriate-Use-Criteria- proposed definitions. through an electronic list of all ICD–9 Program/index.html.

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Using the above methodology, we clinical areas. These reflect both the some of the most disruptive diseases in developed and proposed eight priority significance and the high prevalence of the Medicare population.

TABLE 40—PROPOSED PRIORITY CLINICAL AREAS WITH CORRESPONDING CLAIMS DATA

Proposed priority clinical area Total % Total Total % Total services services 1 payments payments 1

Chest Pain (includes angina, suspected myocardial infarction, and suspected pulmonary embolism) ...... 4,435,240.00 12 $470,395,545 14 Abdominal Pain (any locations and flank pain) ...... 2,973,331.00 8 235,424,592 7 Headache, traumatic and non-traumatic ...... 2,107,868.00 6 89,382,087 3 Low back pain ...... 1,883,617.00 5 180,063,352 5 Suspected stroke ...... 1,810,514.00 5 119,574,141 4 Altered mental status ...... 1,782,794.00 5 83,296,007 3 Cancer of the lung (primary or metastatic, suspected or diagnosed) ...... 1,114,303.00 3 154,872,814 5 Cervical or neck pain ...... 1,045,381.00 3 83,899,299 3 1 Percentage of 2014 Part B non-institutional claim line file for advanced imaging services from Medicare claims for beneficiaries who are enrolled in the fee-for-service (FFS) program (source: CMS Chronic Conditions Data Warehouse).

We also engaged the CMS Alliance to which these proposed priority clinical commenters were concerned that there Modernize Healthcare (CAMH) areas may be represented by clinical were not high quality AUC available to Federally Funded Research and guidelines or AUC in the future. cover such a vast clinical area. For Development Center (FFRDC), the Furthermore, we were interested in suspected stroke, commenters were MITRE Corporation (MITRE), to begin public comments, supported by concerned that using this area for future developing efficient and effective published information, for varying outlier calculations would not be processes for managing current and levels of evidence that exist across, as beneficial as advanced imaging for these future health technology assessments. well as within priority clinical areas. patients may be exempt from this MITRE generated an independent report The following is a summary of the program under the emergency medical that presents a summary of findings comments we received on the list of conditions exception. Commenters from claims data from the Medicare priority clinical areas which may serve disagreed with both suspected stroke population and their utilization of as part of the basis for identifying and altered mental status because both advanced imaging procedures. Coupled outlier ordering professionals. could fall under other priority clinical with our internal analysis, this report Comment: Many commenters areas and they noted there was a lack of has assisted in identification of addressed the proposed list of priority high quality AUC available to address proposed priority clinical areas for the clinical areas. Some commenters them. Medicare AUC program for advanced suggested that many of the proposed Some commenters encouraged and diagnostic imaging services. Analysis priority clinical areas were too large and others discouraged CMS from and methods for this report are available each area was too broadly defined. at https://www.mitre.org/publications/ Commenters expressed concerns that considering alternative priority clinical technical-papers/claims-data-analysis- the proposed list does not permit a areas. Some commenters generally to-define-priority-clinical-areas-for- meaningful, focused approach. As an asked CMS to refrain from considering advanced. alternative, one commenter encouraged other clinical areas beyond what is While this year we proposed priority CMS to limit the number of priority listed in the CY 2017 PFS proposed clinical areas based on an analysis of clinical areas from eight to four. Other rule. Other commenters offered claims data alone, we may use a commenters noted that broadly defined alternatives in both number and scope different approach in future rulemaking priority clinical areas might result in of priority clinical areas. Other cycles. As we specified in § 414.94(e) of little opportunity for a change in commenters suggested including our regulations, we may consider factors behavior of ordering professionals. musculoskeletal (hip pain, knee pain, other than volume when proposing Commenters supported inclusion of low joint pain, shoulder pain, rotator cuff priority clinical areas including back pain and headache in the list of injury), other cancers (breast, prostate), incidence and prevalence of disease, priority clinical areas. One commenter right upper quadrant pain, solitary variability of use of particular imaging specifically recommended that CMS pulmonary nodule, pancreatitis, services, strength of evidence refine the proposed clinical areas of appendicitis, renal colic, suspected supporting particular imaging services ‘‘low back pain’’ and ‘‘headache’’ to abdominal aortic dissection, CT for and the applicability of a clinical area reflect differences between the elderly minor blunt head trauma, suspected to a variety of care settings and to the and non-elderly populations. Other cardiac ischemia, and hematuria. One Medicare population. commenters noted the possibility of commenter noted that the top ten We encouraged public comments on overlap between priority clinical areas conditions for which advanced imaging this proposed initial list of priority of headache, suspected stroke, and is requested included low back pain, clinical areas, including altered mental status, and some headache, and cervical pain. Another recommendations for other clinical commenters recommended combining commenter recommended that these areas that we should include among our such areas. priority clinical areas should be phased list of priority clinical areas. In Other commenters recommended in at a rate of two per year, with particular, we were interested in eliminating suspected stroke, altered examples of pulmonary embolism and comments on the above methodology or mental status, chest pain and abdominal low back pain (as areas where strength alternate options; whether the proposed pain, and creating a stand-alone priority of evidence was particularly high), priority clinical areas are appropriate clinical area for suspected pulmonary which echoed other general comments including information on the extent to embolism. For abdominal pain, to more gradually expand the list of

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priority clinical areas after testing and in 2014 for clinical presentations related clinical areas of headache (traumatic as deemed necessary. to joint pain. Furthermore, we agree and non-traumatic), low back pain, Response: We agree that if priority with commenters who suggested CMS cancer of the lung (primary or clinical areas are too broadly defined, it consider additional clinical areas with a metastatic, suspected or diagnosed), and would not be consistent with our reasonably robust volume of literature cervical or neck pain. The final list of purpose to offer both comprehensive on appropriate use and agree that the priority clinical areas is as follows: and focused approaches to AUC rollout strength of evidence for imaging use and • Coronary artery disease (suspected into qualified CDSMs. We further agree relevance to the Medicare population or diagnosed). that a central goal of the AUC program supports inclusion of hip pain and • Suspected pulmonary embolism. is to promote appropriate ordering of shoulder pain (to include suspected • Headache (traumatic and non- advanced diagnostic imaging services. rotator cuff injury) in the final list of traumatic). Additionally we appreciate the points priority clinical areas. • Hip pain. made by the commenters and see merit In addition to commenters’ support of • Low back pain. in some of their recommended inclusion of low back pain and • Shoulder pain (to include suspected alternatives for priority clinical areas as headache in the list of priority clinical rotator cuff injury). they take into account factors such as areas, we also note that the MID cites • Cancer of the lung (primary or incidence and prevalence of disease, the clinical research demonstrating that use metastatic, suspected or diagnosed). variability of utilization of specific of clinical decision support was • Cervical or neck pain. imaging services, the strength of associated with a decrease in the Consistent with section 1834(q) of the evidence and AUC available for utilization of lumbar MRIs for low back Act, we are not AUC developers, and consultation for a particular clinical pain and head MRIs for headache. therefore, would not produce AUC scenario, and applicability of each We are finalizing the proposed areas tailored to the elderly population. suggested alternative clinical area to the of low back pain and headache, as well However, § 414.94(c)(1) of our Medicare population and to a variety of as cancer of the lung (primary or regulations requires qualified PLEs to care settings, including the emergency metastatic, suspected or diagnosed). utilize an evidentiary review process department. We have removed altered mental We agree with commenters that chest status and abdominal pain based on the when developing or modifying AUC. pain is a general symptom and too broad concerns expressed by commenters This regulation further requires for a focused priority clinical area. We summarized above, including the lack of qualified PLEs to identify AUC that are further agree with commenters that strong evidence to cover the breadth of relevant to priority clinical areas, and supported creating a stand-alone each of these areas. Based on the specifies that to be considered relevant, priority clinical area for suspected commenters’ concerns we may review the AUC must reasonably address the pulmonary embolism, as discussed in these areas in the future, possibly entire clinical scope of the detail below, and one for coronary narrowing their scope. corresponding priority clinical areas. artery disease. Chest pain may be a Regarding stroke, we acknowledge These requirements and the resulting clinical symptom of underlying that evidence-based stroke protocols do fundamental process ensures that AUC suspected pulmonary embolism and exist, however, we believe that it is are evidence-based to the extent feasible coronary artery disease. There is a solid possible that an exception for as required by section 1834(q)(1)(B) of evidence base from well designed, emergency medical services may the Act. Therefore, we expect that randomized controlled trials supporting disproportionally apply to suspected qualified PLEs will undertake evidence specific protocols and guidelines that stroke so there may be a concern for reviews of sufficient depth and quality consider different signs, symptoms and using this priority clinical area for to ensure that all relevant evidence- history associated with working up a future outlier calculations. Furthermore, based publications in the peer-reviewed patient with suspected pulmonary there may be some overlap of the medical literature on trials, embolism. There is also strong evidence clinical areas of suspected stroke and observational studies, and consensus from multiple large, randomized headache. A strong level of evidence statements are identified, considered controlled trials to guide imaging for specific to headache is available and we and evaluated; and that such reviews coronary artery disease. We note that, believe headache is less likely to be are reproducible. according to the American Heart impacted by the emergency medical We do not agree with the suggestion Association Statistical Update, coronary services exception. Therefore, we are to reduce the total number of priority artery disease is the leading cause of removing suspected stroke and retaining clinical areas we proposed in CY 2017 death among men and women in the headache in the final list of priority rulemaking, and reiterate that ordering United States. The evidence is less clinical areas. We may consider adding professionals must consult AUC for all robust for many other causes of chest suspected stroke through future applicable imaging services, not only pain. Therefore, based on the above, we rulemaking. those falling within a priority clinical are removing chest pain as a priority In response to public comments and area. Furthermore, we anticipate that clinical area and finalizing suspected as supported by the additional additional priority clinical areas will be pulmonary embolism and coronary information above and further proposed in future rulemaking, and we artery disease as two distinct areas. discussion below, we have modified the believe that Medicare beneficiaries will We recognize, along with list of priority clinical areas by: (1) benefit as ordering professionals become commenters, that the proposed list of removing chest pain, abdominal pain familiar with specified applicable AUC priority clinical areas did not include (any locations and flank pain), relevant to all advanced diagnostic scenarios specific to musculoskeletal suspected stroke and altered mental imaging services. indications. As stated in the proposed status; and (2) adding coronary artery Comment: One commenter suggested rule, CMS also engaged MITRE to disease (suspected or diagnosed), diagnosimetrics—the application of generate an independent report, which suspected pulmonary embolism, hip quantitative analysis to the art of disease indicates that almost half a million pain and shoulder pain (to include diagnosis—as an alternative approach to advanced diagnostic imaging services suspected rotator cuff injury). We are clinical assessment and reassessment, were rendered to Medicare beneficiaries finalizing as proposed the priority which the commenter believed is an

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approach that obviates the need to Comment: Some commenters the CY 2017 PFS proposed rule, where develop priority clinical areas. advocated for the addition of lung we solicited comments on Response: We appreciate alternative cancer screening to the list of priority recommendations for additional or considerations for implementation of clinical areas. The commenters alternative areas to be included on our the AUC program, but we disagree that suggested that the inclusion of lung list of priority clinical areas. We believe utilization of diagnosimetrics can cancer screening would be beneficial as that the final list of priority clinical eliminate completely the need to there are well-defined and evidence- areas is responsive and reflects the establish priority clinical areas. We based criteria outlining the population expressed needs and concerns of most remind all commenters that we set forth that benefits from screening commenters. the list of priority clinical areas not only examinations. One commenter remarked Comment: Although several to strike a balance between the focused on the opportunity it offers for qualified commenters generally agreed with the and comprehensive approach to PLEs and CDSMs to gain experience approach used to identify priority implementing the AUC program, but with decision support for a population clinical areas, some expressed concern also to be transparent about the areas screening test which may differ from a about the underlying methodology. that we anticipate will serve as the basis diagnostic test. Many commenters believed that when for identifying outlier professionals in Response: We agree with the we provided claims data analysis and the future. We again note that commenter that it is important for ICD–9 diagnosis codes to describe consultation of AUC will be required for qualified PLEs and qualified CDSMs to priority clinical areas, we only all advanced diagnostic imaging interface to gain experience with considered volume and cost of services regardless of whether they fall implementing specified applicable AUC advanced diagnostic imaging services. into a priority clinical area or not. into an appropriateness rating, Some commenters requested CMS Comment: Many commenters specifically for advanced diagnostic include and/or remove ICD–9 diagnosis recommended that pulmonary imaging services. We also appreciate codes in one or more of the embolism be included as a stand-alone feedback on areas for which AUC have supplemental tables accompanying the list of priority clinical areas. Many priority clinical area, based in part on been developed. However, section 1834(q)(1) of the Act limits this program commenters believed that the high strength of evidence from multiple, to promoting the use of AUC for supplemental table encompassed what large multicenter, randomized advanced diagnostic imaging services, CMS believed to be the entire clinical controlled trials (RCTs), and several not to include screening tests. scope of the proposed priority clinical commenters disagreed. The majority of Comment: Several commenters area, while others believed that CMS commenters in support of pulmonary explicitly raised concerns regarding the did not explain what constitutes a embolism believed that it should be a scope, number, and frequency with priority clinical area such as low back priority clinical area distinct from chest which the list of priority clinical areas pain. As a consequence, some pain, and further recommended that would continue to grow. Many commenters requested that CMS define CMS remove or more narrowly commenters noted that a program with priority clinical areas to include all determine any priority clinical area for too many priority clinical areas would applicable diagnosis codes, and map chest pain. In particular, one commenter potentially obstruct any meaningful those diagnosis codes to the most recent did not support inclusion of pulmonary focused approach. Other commenters ICD–10 diagnosis codes available. One embolism as a separate category stating either supported or offered no commenter requested that CMS confirm that eight areas is an appropriate objections to the proposed number of that the data used to ascertain the number for the first year of the program. priority clinical areas. Some priority clinical areas did not include Another commenter supplied published commenters provided additional services provided in the inpatient and evidence that the decision rules for considerations to impact the selection of emergency department settings. Another assessing risk of pulmonary embolism additional priority clinical areas commenter questioned whether the have not been shown to improve including but not limited to the strength inclusion of too many minor or common appropriate use of diagnostic imaging of evidence supporting the use or non- symptoms in the data gathering process when compared to clinical judgment use of a particular imaging service, the would consequently weaken the alone. One commenter suggested having variability of use of a particular imaging implementation of the AUC program the pulmonary embolism priority service, and the representation of a generally. clinical area apply to CT angiograms given clinical grouping to the existing Response: We equally acknowledge only. We received one comment that list of priority clinical areas. the commenters that agreed with our ‘‘shortness of breath’’ rather than Response: We recognize these approach and those that raised concerns ‘‘pulmonary embolism’’ be included as concerns and reiterate that we do not with our methodology. Section a stand-alone priority clinical area. believe there is just one correct criterion 414.94(e)(2) of our regulations, as Response: We appreciate the to form the basis for expanding the list finalized in the CY 2016 PFS final rule extensive input on this topic and we of priority clinical areas over time. We with comment period, states that, when agree with the majority of commenters, agree with commenters who encouraged identifying priority clinical areas, we and thus, are finalizing suspected us to consider the breadth and depth of will consider incidence and prevalence pulmonary embolism as a priority clinical scenarios within the proposed of disease, the volume and variability of clinical area. We not that qualified PLEs priority clinical areas, and acknowledge use of particular imaging services, and already have AUC for suspected the impact of priority clinical areas for strength of evidence supporting pulmonary embolism that are based on calculation of outlier ordering particular imaging services, as well as large, multi-center, randomized professionals. We expect the list of applicability of the clinical area to a controlled trials. These evidence-based priority clinical areas to expand over variety of care settings and to the AUC in turn are further supported by time in a judicious and stepwise manner Medicare population. In the CY 2017 the American Board of Internal through consultation with physicians PFS proposed rule, we proposed Medicine (ABIM) Foundation’s and other stakeholders and through the priority clinical areas based on an Choosing Wisely® list of society annual notice and comment rulemaking analysis of claims data, using subjective recommendations. process. We have demonstrated this in clinical judgment on whether a

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particular ICD–9 diagnosis code should conditions exception, noting that there area was intended only to explain the be included in a given clinical grouping. may be little impact in proposing to portion of Medicare claims data derived We remind all commenters that the address clinical areas exempt from AUC from the CCW 2014 Part B non- supplemental table was provided to consultation. Furthermore, some institutional claim line file for services lend insight into the extent to which a commenters requested that CMS furnished during CY 2014. We remind given diagnosis code contributes to exclude from priority clinical area all commenters that these data were orders for advanced diagnostic imaging consideration those clinical scenarios used to calculate the total services services, which we used to assist us in for which advanced imaging tests are furnished and total payments made to identifying proposed priority clinical rarely inappropriate, which commenters those enrolled in Medicare Part B. We areas. We continue to believe that the stated would reduce alert fatigue by included this supplemental table to be list of priority clinical areas should ordering professionals and increase open and transparent to stakeholders reflect both the significance and high focus on clinical scenarios for which regarding the process by which we prevalence of some of the most ordering professional behavior may be developed the proposed list of priority disruptive diseases in the Medicare altered. clinical areas. We reiterate that our use population. In particular, the claims Response: Although this year we of the ICD–9 diagnosis codes from CY data analysis we undertook did not proposed priority clinical areas based 2014 claims data was solely a means for include services furnished in the partly on an analysis of claims data, we estimating volumes of procedures, as a inpatient setting, but did include also considered stakeholder feedback stepping stone in the development of an services provided in an emergency and commenters’ alternative initial list of priority clinical areas. In department as section 1834(q)(4)(C) of considerations. We acknowledge the the event we use claims data from 2015 the Act excludes applicable imaging merit of several acceptable alternative or later for analyses, we will use ICD– services ordered for individuals with proposals and believe the current 10 codes, but will continue to assess all emergency conditions as defined in definition of priority clinical areas options for identifying and establishing section 1867(e)(1) of the Act, but does encompasses these considerations. We priority clinical areas and not not exclude all applicable imaging will continue to maintain close dialogue necessarily limit ourselves only to ICD services provided in the emergency with physicians and other stakeholders, diagnosis code analyses. department from the consultation and may use a different approach to We acknowledge the alternative requirement under this program. We addressing priority clinical areas in opinions of commenters seeking to further agree with the commenters’ future rulemaking cycles, as needed. modify the extent of diagnosis codes in observations that a high volume Comment: Some commenters one or more priority clinical areas. We advanced diagnostic imaging service expressed additional concerns about the hope to discuss further with physicians does not by itself indicate high rates of use of diagnosis codes to help form and other stakeholders the relevance of inappropriate testing. Therefore, we are priority clinical areas. One commenter mapping ICD diagnosis codes to priority modifying the proposed list of priority noted that using a diagnosis for clinical areas as we move forward in clinical areas to more closely align with suspected stroke should also include formulating the claims reporting feedback from commenters on the other diagnoses in the priority clinical implementation strategy (discussed in strength of evidence and AUC available area, such as facial numbness, slurred more detail below) and strategies to for clinical scenarios within a given speech, or limb weakness. Other avoid areas of concern for commenters. clinical area. commenters expressed concerns that We clarify that ICD–9 diagnosis codes Given the transition to ICD–10 in publishing a rigid, exact mapping of ICD will not be used for claims reporting 2015 and changes in the list of priority diagnosis codes for each priority clinical purposes in this program given the 2015 clinical areas, as well as factors area could give rise to ‘‘gaming.’’ Other transition to ICD–10. We expect that the discussed above, we clarify that the commenters noted that addressing role of ICD–10 diagnosis codes for the supplemental table does not define the priority clinical areas with diagnosis purposes of claims based reporting, final list of priority clinical areas. We codes is problematic because the final auditing and outlier identification will expect to address the role of ICD–10 diagnosis code is often not known until be addressed through rulemaking next diagnosis codes in claims based the advanced imaging study is year. reporting, auditing and outlier completed. Comment: Some commenters stated identification for priority clinical areas Response: We recognize that these that AUC consultation within priority with rulemaking next year. We note, comments exemplify the confusion and clinical areas include only high-quality however, that we believe that the list of concerns expressed by many evidence and recommended further priority clinical areas provides commenters about the definition of each consideration and discussion of the sufficient guidance to CDSMs as they priority clinical area. We did not level of evidence available for AUC in decide whether to apply to be a propose to set forth a diagnosis-code each priority clinical area. One qualified CDSM in the upcoming based definition for each priority commenter requested that CMS specify application cycle. clinical area; rather, we will continue to a standard for the strength of any Comment: Several commenters use the definition of priority clinical evidence. Many commenters offered to provided alternative considerations to areas in § 414.94(b) which includes share their guidelines, guidance and methodically determine priority clinical clinical conditions, diseases or other expertise around AUC with CMS, areas, including ICD–10 diagnosis symptom complexes and associated and recommended that CMS engage codes, CPT codes, hierarchical advanced diagnostic imaging services with them directly. Other commenters condition categories, anatomical identified by CMS through annual suggested that the proposed priority regions, variation in treatment, and rulemaking and in consultation with clinical areas more closely align with quality of the evidence. A few stakeholders which may be used in the the ABIM’s Choosing Wisely® initiative commenters suggested that CMS also determination of outlier ordering and/or the ACR’s Appropriateness consider the extent to which the professionals. In addition, we clarify Criteria®. One commenter majority of clinical scenarios within a that our submission of supplemental recommended a number of evidence- priority clinical area would likely fall data presenting ICD–9 diagnosis codes based guidelines for imaging of patients under the emergency medical within each proposed priority clinical with traumatic cervical pain. In

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conjunction with the evidence should incorporate such high quality have in identifying prospectively which submitted to support one or more AUC as part of a clinical decision tree, clinical scenarios pertain to a priority priority clinical areas, another which includes areas where imaging is clinical area. We remind commenters commenter suggested only including triggered by other tests. that ordering professionals will be those priority clinical areas for clinical We continue to believe that evidence required to consult specified applicable scenarios for which AUC from multiple grading is an essential component of the AUC through a qualified CDSM for all PLEs are available. AUC development process for all applicable imaging services and will not Some commenters also shared with clinical areas, including priority clinical be required to determine which CMS publications that suggested a lack areas. However, we acknowledge that applicable imaging services fall within of evidence-based AUC for clinical different grading systems may be more priority clinical areas. For the purposes scenarios that could reasonably fall appropriate for different clinical areas. of the AUC program, priority clinical within one or more proposed priority As such, we will not require the use of areas will be used as part of the input clinical areas. In particular, one specific grading mechanisms and leave to calculate outlier ordering commenter believed that available that decision to qualified PLEs. We professionals. We will address the appropriateness criteria do not address recognize that some AUC development identification of outlier ordering altered mental status. Commenters processes could invite public comment professionals for this program, as generally believed that clinical and include a wide range of experts and specified in section 1834(q)(5) of the scenarios providing no appropriateness stakeholders on the multidisciplinary Act, in future rulemaking. rating or contradictory AUC development team. However, we Regarding local adaptation, we recommendations from CDSMs based on will not establish these as requirements, believe it is important to fit AUC to AUC using lower grades of evidence or and instead require under § 414.94(c)(1) local circumstances, while also ensuring expert opinion would not result in that qualified PLEs post AUC along with a rigorous process for doing so. significant modifications in ordering the process they use for developing and However, only AUC modified by professional behavior. A commenter modifying AUC on their Web site in the qualified PLEs can become specified suggested CMS consider the safety public domain to allow for review by all applicable AUC. Furthermore, qualified margin inherent in the clinical area stakeholders. PLEs are required under our regulation where imaging for acute stroke, for Comment: Some commenters at § 414.94(c)(v) to identify each example, has a narrow safety margin expressed confusion over which entity appropriate use criterion or AUC subset while imaging for suspected rotator cuff determines whether an exam falls that is relevant to a priority clinical injury has a wider safety margin. Many within a priority clinical area for the area. Stakeholders should expect to see commenters identified situations when ordering professional. Several such delineations on the Web site of the the available high-quality evidence does commenters noted that determining qualified PLE. not cover the entire clinical scope of a whether an exam falls under a priority We are not launching an educational priority clinical area. In these situations, clinical area often will not be an easy campaign at this time because this a CDSM would either cover less than yes-or-no decision. One commenter program is only partially implemented. the entire clinical scope of a priority further expressed that this confusion However, we believe that physicians clinical area and only incorporate AUC would result in physicians being and other practitioners, through based on high-quality evidence or cover expected to know if an advanced continued dialogue with us, will the entire clinical scope and in doing so imaging study falls within a priority continue to become more informed as incorporate AUC based on low quality clinical area, which would further implementation of this program evidence and expert opinion. These confuse clinicians about which orders proceeds, and we will continue to commenters cautioned against requiring require consultation with CDSMs and evaluate the programmatic and qualified CDSMs to incorporate which do not. Several commenters educational needs of ordering and specified applicable AUC that explained that ordering professionals furnishing professionals impacted by encompass the entire clinical scope may not know whether they are the AUC program over time. given the potential for forcing required to consult with AUC through a Comment: Many commenters consultation with AUC based on lower qualified CDSM at the time of order expressed confusion regarding when quality evidence. As an alternative, a because the diagnosis is not yet known. consultation with specified applicable few commenters encouraged CMS to Another commenter raised concerns AUC will be required. Some separate priority clinical areas into that not all available specified commenters believed that consultation those that have high quality AUC and applicable AUC within priority clinical for all advanced diagnostic imaging those that do not. areas, especially those developed by services will be required, while others Response: We agree that priority general hospitals or by professional believed that CMS proposed to limit the clinical areas for which there is little societies, will be well suited for local consultation requirement to only evidence would likely have little impact adaptation, a particular practice, or the advanced diagnostic imaging services in changing physician ordering patients it serves. To address these within priority clinical areas. Some behavior, and may indeed negatively concerns, commenters made a few commenters recommended that impact patient care. We expect qualified recommendations to CMS. Specifically, physicians and other practitioners be PLEs to identify and focus on that commenters suggested qualified PLEs required to consult AUC only within the portion of the entire clinical scope should be responsible for certifying priority clinical areas. Commenters within a given priority clinical area whether an AUC set encompasses the believed the impact of limiting AUC where there is sufficient evidence to entire scope of a priority clinical area. consultation to only imaging studies create high quality AUC. We encourage Additionally, commenters falling within priority clinical areas qualified PLEs to consider the ‘‘safety recommended that CMS develop and would be a decrease in the consultation margins’’ discussed above along with launch an educational campaign, and reporting for ordering professionals. strength of evidence and other factors including a Town Hall meeting. Other commenters recommended a when developing or modifying AUC. Response: We understand the narrower requirement for only ordering Furthermore, we believe that qualified commenters’ concerns about the professionals who meet an ordering CDSMs, working with qualified PLEs, difficulty ordering professionals may threshold or who order from a list of

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specified conditions within their many commenters urged CMS to collect standards development organizations specialty to consult AUC for only at least one year of data from the start come to consensus regarding standards priority clinical areas. While still other of the program and use it to identify for CDSMs, then we may consider commenters recommended that ordering priority clinical areas where the AUC pointing to such standards as a professionals be required to consult program can help reduce variation. requirement for qualified CDSMs under AUC for advanced diagnostic imaging Response: Although commenters this program. We believe standards services including and beyond the appreciated the utility in defining would make it possible to achieve priority clinical areas. Another priority clinical areas for the purposes interoperability, allowing any CDSM to recommendation from commenters of identifying outlier ordering incorporate any standardized AUC and included requiring only some ordering professionals, we reiterate that we have for sets of AUC to be easily professionals consult AUC for limited yet to propose the policies for the interchangeable among various CDSMs. applicable imaging services by imaging annual identification of outlier ordering We will continue to work with the ONC modality. Several commenters agreed professionals, and therefore, will revisit and AHRQ to facilitate movement in with our proposed definition of the comments on this subject in the course this direction. applicable payment systems under of rulemaking for the CY 2018 PFS. We Recent work under the federally- which consultation with AUC for an remind all commenters that section sponsored Clinical Quality Framework advanced diagnostic imaging service 1834(q)(5) of the Act explicitly requires (CQF) initiative has successfully would be paid. that the Secretary shall use 2 years of developed an integrated approach that Response: We understand data to identify outlier ordering harmonizes standards for electronic commenters’ confusion and expect that, professionals for the purposes of the clinical quality measurement with those in general, the additional regulations we AUC program. that enable shareable clinical decision are finalizing in this final rule will In response to comments, we are support artifacts (for example, AUC) provide greater clarity. Section finalizing a modified list of priority using Fast Healthcare Interoperability 1834(q)(4) of the Act sets forth the clinical areas under § 414.94(e)(5) of our Resources (FHIR). The CQF initiative is requirement that ordering professionals regulations, making the following working to support semantically must consult with specified applicable changes from the proposed list: (1) interoperable data exchange for (1) AUC through a qualified CDSM for an removed chest pain, abdominal pain calling a service, sending patient data to applicable imaging service furnished in (any locations and flank pain), a service for clinical decision support an applicable setting and paid for under suspected stroke and altered mental guidance and receiving clinical decision an applicable payment system. The status; and (2) added coronary artery support guidance or quality applicable imaging services are not disease, (suspected or diagnosed), measurement results in return, and (2) limited under the statute to any suspected pulmonary embolism, hip enabling a system to consume and particular clinical area. Therefore, we pain and shoulder pain (to include internally execute decision support do not have statutory authority to limit suspected rotator cuff injury). We are artifacts. The current implementation the consultation requirement to priority finalizing the proposed priority clinical guide supports both approaches and clinical areas. We reiterate that priority areas of headache (traumatic and non- could be used to successfully execute clinical areas may be used in the traumatic), low back pain, cancer of the and share AUC as described in this identification of outlier ordering lung (primary or metastatic, suspected program. As this standard is considered professionals under a future component or diagnosed), and cervical or neck pain sufficiently mature for widespread of this program. By starting to identify without change. adoption, the ONC may consider it for these areas now, we believe physicians c. CDSM Qualifications and use in future editions of certification and practitioners will have the Requirements criteria for health IT. While the current opportunity to become familiar with regulation requires no specific standard, AUC within identified priority clinical We proposed to add a new the CMS and ONC are supportive of this areas prior to Medicare claims for those § 414.94(g)(1) to our regulations to approach and additional information is services being part of the input for establish requirements for qualified available at http://hl7-fhir.github.io/ calculating outlier ordering CDSMs. Section 1834(q)(3)(A)(iii) of the clinicalreasoning-module.html. It professionals. We further believe that Act provides relative flexibility for should be noted that there are also AUC consultation will help to improve qualified CDSMs, and states that they existing deployed standards for clinical appropriate utilization among all may include mechanisms that are decision support and these and professionals and will continue to within certified EHR technology, private emerging standards can be found in the engage stakeholders to further this sector mechanisms that are independent ONC Interoperability Standards shared goal. from certified EHR technology or Advisory (https://www.healthit.gov/ Comment: Many commenters mechanisms that are established by the standards-advisory). suggested that they agreed with the Secretary. At § 414.94(g)(1), we proposed to approach of CMS to use the priority We believe that, at least initially, it is codify in regulations the seven clinical areas for the purposes of in the best interest of the program to requirements for qualified CDSMs set identifying outlier ordering establish CDSM requirements that are forth in section 1834(q)(3)(B)(ii) of the professionals. In contrast, one not prescriptive about specific IT Act. The statute requires qualified commenter expressed that denial of standards. Rather, we proposed an CDSMs to make available to the medical services based on criteria approach that focuses on the ordering professional specified designed solely to decrease the functionality and capabilities of applicable AUC and the supporting utilization of medical imaging runs qualified CDSMs. The CDSM, EHR and documentation for the applicable counter to the underlying goal of the health IT environments are constantly imaging service ordered. We do not AUC program under section 218(b) of changing and improving and we want to interpret this requirement to mean that the PAMA. Commenters also generally allow room for growth and innovation. every qualified CDSM must make agreed that the impact of the AUC However, in the future, as more available every specified applicable program could not be fully realized stakeholders and other entities AUC. In the CY 2016 PFS final rule with until after implementation; therefore, including the ONC, AHRQ, and relevant comment period, we allowed for the

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approval of massive libraries of AUC represent AUC across all priority applicable’’ when the mechanism does (resulting from approvals for qualified clinical areas (consistent with the not contain a criterion that would apply PLEs with comprehensive and extensive requirements under proposed to the consultation. This determination libraries), yet we expressed our § 414.94(g)(1)(iii)). We do not would communicate the intention to establish priority clinical necessarily expect that a single qualified appropriateness of the applicable areas. While there is a statutory PLE will develop AUC addressing every imaging service to the ordering requirement to consult AUC for each priority clinical area domain, especially professional. In addition to this applicable imaging service, we since we believe that over time and determination, we also proposed that recognize that ordering professionals through future rulemaking, the list of the CDSM provide the ordering may choose to thoroughly improve their priority clinical areas will expand and professional with a determination of understanding of, and focus their cross additional clinical domains. ‘‘not applicable’’ when the mechanism internal quality improvement (QI) Ensuring that qualified CDSMs are not does not contain an appropriate use programs on, those priority clinical limited in their technology to criterion applicable to that patient’s areas; and these areas will in turn serve incorporating AUC from only one specific clinical scenario. as the basis for future outlier qualified PLE will help to ensure that We proposed to add a requirement in calculations. ordering professionals will not be in a § 414.94(g)(1)(vi), consistent with Consistent with that approach, we position of consulting a CDSM that section 1834(q)(3)(B)(ii)(IV) of the Act, proposed to add a requirement in cannot offer them access to AUC that that the qualified CDSM must generate § 414.94(g)(1)(iii) that qualified CDSMs address all priority clinical areas. As and provide to the ordering professional must make available to ordering stakeholders continue to advance CDSM certification or documentation that professionals, at a minimum, specified technology, we look forward to documents which qualified CDSM was applicable AUC that reasonably standards being developed and widely consulted, the name and NPI of the encompass the entire clinical scope of accepted so that AUC are incorporated ordering professional that consulted the all priority clinical areas. We encourage in a standardized format across CDSM CDSM and whether the service ordered and expect some CDSMs, based on the platforms. Increasing standardization in would adhere to applicable AUC, needs of the professionals they serve, this area will move the industry closer whether the service ordered would not will choose to include a far more to the goal of interoperability across adhere to such criteria, or whether such comprehensive set of AUC going above CDSMs and EHRs. criteria was not applicable for the and beyond the minimum set as we We also proposed to add a service ordered. We proposed to require understand many ordering professionals requirement in § 414.94(g)(1)(i) that under § 414.94(g)(1)(vi)(A) that this want such comprehensive access to specified applicable AUC and related certification or documentation must be AUC. When this Medicare AUC program documentation supporting the issued each time an ordering is fully implemented, all ordering appropriateness of the applicable professional consults the qualified professionals must consult specified imaging service ordered must be made CDSM. Since Medicare claims will be applicable AUC through a qualified available within the qualified CDSM. filed only for services that are rendered CDSM for every applicable imaging For example, the ordering professional to beneficiaries, we will not see CDSM service that would be furnished in an would have immediate access to the full consultation information on the claim applicable setting and paid for under an appropriate use criterion, citations form specific to imaging services that applicable payment system in order for supporting the criterion and a summary are not ordered. We believe that for the payment to be made for the service. of key evidence supporting the criterion. CDSM to be able to provide meaningful However, when identifying the outlier We proposed to add a requirement in feedback to ordering professionals, ordering professionals who will be § 414.94(g)(1)(ii), consistent with section information regarding consultations that subject to prior authorization beginning 1834(q)(3)(B)(ii)(II) of the Act, that the do not result in imaging is just as in 2020, we anticipate focusing on qualified CDSM must clearly identify important as information on consultation with specified applicable the appropriate use criterion consulted consultations that do result in an order AUC within priority clinical areas rather if the tool makes available more than for advanced imaging. than the universe of specified applicable one criterion relevant to a consultation Thus, we proposed to require under AUC. The concept of priority clinical for a patient’s specific clinical scenario. § 414.94(g)(1)(vi)(B) that the areas will allow us to implement an We believe this is important since documentation or certification provided AUC program that combines two CDSMs that choose to incorporate a by the qualified CDSM must include a approaches to implementation allowing comprehensive AUC library may be unique consultation identifier. This clinicians flexibility to either engage offering the ordering professional access would be a unique code issued by the with a rapid rollout of comprehensive to AUC from multiple qualified PLEs. In CDSM that is specific to each specified applicable AUC or adopt a such scenarios, it is important that the consultation by an ordering focused approach to consulting AUC. ordering professional knows which professional. This type of unique code Thus, they can choose their approach appropriate use criterion is being may serve as a platform for future and select a CDSM and AUC set(s) that consulted and have the option to choose collaboration and aggregation of fit their needs and preferences, while one over the other if more than one consultation data across CDSMs. In being sure that each qualified CDSM criterion accessible within the CDSM addition, at some point in the future, will include AUC that address all applies to the scenario. this unique code may assist in more priority clinical areas. We proposed to add a requirement in seamlessly bringing Medicare data We further proposed to add a § 414.94(g)(1)(v), consistent with section together with CDSM clinical data to requirement in § 414.94(g)(1)(iv) of our 1834(q)(3)(B)(ii)(III) of the Act, that the maximize quality improvement in regulations that qualified CDSMs must qualified CDSM must provide to the clinical practices and to iteratively be able to incorporate specified ordering professional a determination, improve the AUC itself. We proposed in applicable AUC from more than one for each consultation, of the extent to § 414.94(g)(1)(vii), consistent with qualified PLE. We believe this approach which an applicable imaging service is section 1834(q)(3)(B)(ii)(V) of the Act, ensures that CDSMs can expand the consistent with specified applicable that the specified applicable AUC AUC libraries they can provide access to AUC or a determination of ‘‘not content within qualified CDSMs be

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updated at least every 12 months to § 414.94(g)(1)(x) that a qualified CDSM As noted, we believe examples of reflect revisions or updates made by must maintain electronic storage of CDSMs that seamlessly integrate with qualified PLEs to their AUC sets or to clinical, administrative and EHRs, including those that operate an individual appropriate use criterion. demographic information of each outside of certified EHR technology, We proposed 12 months as the unique consult for a minimum of 6 such as those that operate in the cloud, maximum acceptable time frame for years. We believe CDSMs could fulfill will likely be most effective in meeting updating content. We believed that in this requirement in a number of ways, clinicians’ needs. As the market most cases it will be possible to update including involving a third party in the continues to mature, we would expect AUC content more frequently than every storage of information, as well as for to see expanded availability of easily 12 months, particularly for cloud-based providing feedback to ordering affordable tools that fully integrate AUC CDSMs. We further proposed in professionals. We recognize that these guidance with an efficient, clinician- § 414.94(g)(1)(vii)(A) that qualified requirements represent a minimum floor friendly workflow within the interface CDSMs have a protocol in place to more that clinicians may choose to expand of the primary health IT system they use expeditiously remove AUC that are their local QI programs. in providing and documenting care. determined by the qualified PLE to be In the event requirements under Comment: Several comments potentially dangerous to patients and/or § 414.94(g)(1) are modified through addressed our approach to CDSM harmful if followed. rulemaking during the course of a requirements and noted that we focused In addition, we proposed in qualified CDSM’s 5-year approval cycle, on functionalities and capabilities of a § 414.94(g)(1)(vii)(B) that qualified we proposed in § 414.94(g)(1)(xi) that mechanism for flexibility as opposed to CDSMs must make available for the CDSM would be required to comply prescriptive and specific IT standards. consultation specified applicable AUC with the modification(s) within 12 Commenters overwhelmingly favored that address any new priority clinical months of the effective date of the the approach we proposed. Commenters areas within 12 months of the priority modification. indicated that the current state of CDSM clinical area being finalized by CMS. We The following is a summary of the technology is varied and there are not believe this would allow the CDSM comments we received on CDSM yet accepted, mature standards sufficient time to incorporate the AUC qualifications and requirements. available. Many of these commenters into the CDSM. Thus, any new priority encouraged CMS to cooperate with Comment: We received numerous clinical areas finalized, for example, in ONC, Health Level Seven International comments both for and against the CY 2018 PFS final rule that would (HL7) and other standards organizations including qualifying CDSMs that are be effective January 1, 2018, would need to work toward identifying standards in freestanding, web-based and operating to be incorporated into a qualified the near future. Some commenters, outside of a certified EHR environment. CDSM by January 1, 2019. To however, pointed out that the lack of Some of those commenters pointed out accommodate this time frame, we would standards early in the program could CMS statements indicating that ideally accept a not applicable determination lead to chaos in the market and increase from a CDSM for a consultation on a a CDSM would be seamlessly integrated costs since CDSM developers will not priority clinical area for dates of service into the clinical workflow, which could have a set of standards on which to through the 12-month period that ends, be possible when the CDSM is build. in this example, on January 1, 2019. We completely integrated within an Response: We do not believe it is note that all qualified CDSMs that are ordering professional’s EHR. Those in possible to require standards at this time approved by June 30, 2017, should be favor of a freestanding CDSM cited the due to the lack of agreement among capable of supporting AUC for all importance of allowing choice as there stakeholders regarding which technical priority clinical areas that are finalized are some instances where a freestanding standards should be identified. We in the CY 2017 PFS final rule. mechanism may be preferred, understand that some CDSM developers We proposed to add a requirement in particularly in cases of practitioners would prefer specific guidance from us § 414.94(g)(1)(viii), consistent with who do not use EHR technology or to ensure they are building tools that section 1834(q)(3)(B)(ii)(VI) of the Act, when integration of a CDSM involves meet the needs of the program; that the qualified mechanism must meet high costs or other problems. therefore, we will continue to work with privacy and security standards under Response: Particularly in the early stakeholders like ONC, HL7 and other applicable provisions of law. Potentially stages of this program, we believe it is standards organizations in an attempt to applicable laws may include the HIPAA important to allow for the option of a identify standards in the future. We will Privacy and Security rules. freestanding mechanism that is continue to actively encourage and We proposed to add a requirement in independent of EHR technology, which welcome the input of stakeholders in § 414.94(g)(1)(ix), consistent with is supported by section this matter. As we expect that standards section 1834(q)(3)(B)(ii)(VII) of the Act, 1834(q)(3)(A)(iii)(II) of the Act. For some will continue to develop, evolve and that qualified CDSMs must provide ordering professionals, this will allow gain acceptance, we believe that if we ordering professionals aggregate compliance with the requirements of the were to establish standards now for feedback in the form of an electronic program while still affording them time CDSMs, they would serve only as initial report on an annual basis (at minimum) to make decisions regarding EHR- standards and may quickly become regarding their consultations with integrated CDSMs. In addition, as we obsolete, potentially resulting in specified applicable AUC. Our intent is understand the current marketplace, it confusion for CDSM developers. We to require records to be retained in a is more likely that tools available free of recommend that developers refer to manner consistent with the HIPAA charge may initially begin as web-based ONC’s Interoperability Standards Security Rule. To provide such tools and, we note that, in accordance Advisory (see https://www.healthit.gov/ feedback, and to make detailed with section 1834(q)(1)(C) of the Act standards-advisory) for the most up-to- consultation information available to and as defined in § 414.94(b) of our date standards available, which will ordering professionals, furnishing regulations, an applicable imaging likely be the basis of future professionals (when they have service is one for which there is one or development. authorized access to the CDSM), more qualified CDSM available free of Comment: The majority of auditors and CMS, we proposed in charge. commenters addressed the proposal to

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require qualified CDSMs to contain, at AUC needed by the ordering than one qualified PLE. Some a minimum, AUC that encompass the professionals they serve, as well as commenters agreed with the proposal entire clinical scope of priority clinical contain specified applicable AUC while others suggested a more stringent areas. Commenters were split regarding related to the priority clinical areas, to requirement that the relationship the proposed requirement. Some ensure that when an ordering between the CDSM and at least two commenters suggested that establishing professional needs to consult AUC for PLEs already be established and a minimum scope for CDSM AUC an imaging service, they will not have formalized prior to qualifying a CDSM. content would add cost and be to go outside their regular qualified Other commenters were against making unnecessary for CDSMs that serve CDSM for the consultation. We reiterate this capability a requirement. They specialists. They favored allowing that we envision choices for qualified stated that CDSMs should have the qualified CDSMs to determine, along CDSMs that allow efficient access by flexibility to establish as many or as few with the ordering practitioners they ordering professionals to one or more relationships with PLEs as needed. serve, what AUC content would be specialty-focused specified applicable Response: We are concerned that made available. Other commenters AUC sets along with more removing the requirement for qualified favored requiring every CDSM to comprehensive specified applicable CDSMs to have the ability to incorporate contain comprehensive AUC. Those AUC sets. We believe the determination specified applicable AUC from more commenters said this was the intent of of which AUC sets are made accessible than one qualified PLE would not be in section 218(b) of the PAMA since through a given CDSM should be alignment with our intention to ordering professionals must consult for demand-driven by ordering incorporate specified applicable AUC every advanced diagnostic imaging professionals, who would be choosing that reasonably address the common order, and they believe a comprehensive from a marketplace of options for both and important clinical scenarios within AUC requirement would take into CDSMs and AUC, all of which meet each priority clinical area. This is account the lessons learned from the basic CMS qualifications to ensure important since many qualified CDSMs MID, avoiding frustration of ordering implementation of the statutory will need to work with more than one practitioners who attempt to consult requirements established under section qualified PLE to accomplish such a AUC for imaging services and do not 218(b) of the PAMA. requirement and also to align with CMS’ find relevant AUC within their CDSM. To balance the requirement for the goal to maintain flexibility of qualified Other commenters agreed in principle minimum floor, we believe it is CDSMs to incorporate the best available with the proposal to establish a important to reconsider the extent to AUC. We believe, for now, it is minimum floor of AUC but expressed which specified applicable AUC appropriate to keep this requirement as concerns about the way CMS proposed encompass the entire clinical scope of a capability as opposed to requiring that that the priority clinical areas must be priority clinical areas. We agree that qualified CDSMs demonstrate or share addressed, stating that the requirement requiring the entire clinical scope may with CMS that such contracts are in that AUC encompass the entire clinical not yield consultation of the highest place. scope of priority clinical areas is not quality specified applicable AUC and In future years, as greater consensus preferred and would draw in AUC that ordering professionals, particularly emerges around common standards for without a strong evidence base. specialists, may not have a need for interfacing with, uploading or otherwise Response: We understand the specified applicable AUC addressing the referencing content that is not already in significance of this aspect of the entire clinical scope of a priority the system being used, we expect proposal, as well as the statements made clinical area. We do not expect this incorporation of AUC from a wide range by the commenters both for and against requirement to be met by AUC that of sources to become easier. We the requirement of an AUC floor, or the address only a narrow clinical aspect of encourage systems to build standards- minimum AUC that must be available in a priority clinical area. We believe based mechanisms to incorporate a qualified CDSM, related to priority addressing less than the entire clinical external AUC and anticipate that such clinical areas. We reiterate that, in scope should still result in AUC that an approach would facilitate meeting alignment with statute, ordering robustly fill priority clinical areas. To this requirement. professionals must consult for each avoid forcing the development of AUC Comment: Commenters were pleased advanced diagnostic imaging service based on poor evidence just for the sake with the requirement that the CDSM ordered. Therefore, we believe many of having AUC we modified this make available related documentation to professionals will choose a qualified language and expect it will enable specified applicable AUC supporting CDSM that best fits their ordering qualified PLEs to confidently develop the appropriateness of the imaging patterns and clinical practice. Those AUC that represent a high level of service ordered, and indicated that ordering a wide array of imaging evidence. Therefore, we agree with having access to citations and evidence services or perhaps infrequently commenters’ suggestions that we keep summaries would be helpful. ordering imaging services across a broad the AUC floor but allow the requirement Response: We agree with commenters clinical spectrum will align themselves to be fulfilled if specified applicable and have revised this requirement at with a mechanism that fits their needs AUC address less than the entire scope § 414.94(g)(1)(i) to increase clarity and and contains comprehensive specified of the priority clinical areas and instead confirm commenters’ expressed applicable AUC in order to lessen the reasonably address the common and understanding that qualified CDSMs chances that they find no applicable important clinical scenarios within each must make available specified AUC when they attempt to consult for priority clinical area. We have included applicable AUC and its related a specific service. this modified language in supporting documentation. Specialists may seek to align § 414.94(g)(1)(iii) and Comment: We received comments in themselves with a qualified CDSM that § 414.94(g)(1)(vii)(C). favor of requiring the CDSM to identify contains AUC more exhaustive in one Comment: We also received which appropriate use criterion is being area of medicine to reflect the imaging comments both for and against the consulted in the event the mechanism services that they order most often. proposed requirement that qualified includes AUC from more than one We continue to believe that all tools CDSMs have the ability to incorporate qualified PLE. Additionally, we should contain the specified applicable specified applicable AUC from more received comments regarding who

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makes the determination of which AUC believe, can be somewhat flexible. ‘‘Not We have also revised our proposals in within the mechanism is to be applicable’’ status could occur either § 414.94(g)(1)(vi) to allow for qualified consulted. Some commenters wanted when the AUC scope does not match the CDSMs that are embedded seamlessly more freedom for the ordering patient or their presentation or when no into the EHR system to provide professional to choose at the time of the guideline exists that is appropriate to documentation or certification of CDSM consultation which AUC should be the patient or their presentation. If this consultation without stopping the consulted in the event that there is more situation is the case, it should be workflow of the ordering professional. than one. Other commenters were in documented in the clinical or metadata This minor change in language requires favor of more consistency and not around the particular application or the qualified CDSM to develop the allowing consultation of different AUC attempted application of AUC. documentation or certification at the for the same clinical scenario. For example, if the system only time of the order but will no longer Response: We agree with commenters contains AUC for ‘‘uncomplicated explicitly state that it has to be provided that the capability to choose is critically headache’’ but the patient has presented directly to the ordering professional. important when more than one qualified with ‘‘headache, fever, and altered For consistency, we have made a PLE’s AUC are made available within mental status’’ the practitioner could similar change to § 414.94(g)(1)(vi)(A) to the qualified CDSM. However, we do make the determination that no allow for the documentation or not believe we should be involved in applicable AUC exists for the patient certification to be generated but not determining whether the qualified under consideration and document this necessarily issued directly to the CDSM chooses which specified using a text box, check box, or drop- ordering professional. This may be applicable AUC to display upon down menu. The documentation that important to avoid workflow consultation or whether the ordering the search did not match the existing disruptions when an ordering practitioner should have the ability to AUC and that the practitioner agreed professional is working within their select the specified applicable AUC to that the existing AUC was not EHR environment and the qualified consult. applicable should be retained. CDSM working in the background does Comment: Some commenters were Furthermore, manual intervention by not alert the ordering professional when concerned that the qualified CDSM the practitioner might not be required in they have placed an order that is should not be required to produce all cases in which the use of AUC is not appropriate. documentation when the result of a applicable. We expect that there would We have further modified consultation is ‘‘not applicable.’’ In be a legitimate clinical reason for § 414.94(g)(1)(vi) to more clearly state other words, the CDSM should not make declaring a relevant AUC ‘‘not the requirements that the certification or the determination as to whether AUC applicable’’ to the patient and that this documentation must document which available in the mechanism are relevant reason would be documented. Likewise, CDSM was consulted; the name and NPI to the clinical scenario encountered by we expect that when no applicable AUC of the ordering professional that the ordering professional. Some exists relevant to the patient that would consulted the CDSM; whether the suggested that the ordering professional be similarly documented. CDSMs service ordered would adhere to should have the ability to notate that the should not be designed to permit the specified applicable AUC or whether result of a consultation with a CDSM use of ‘‘not applicable’’ overrides the specified applicable AUC consulted was ‘‘not applicable’’ and that the without a documented reason. Ideally, was not applicable to the service programing required for a mechanism to systems would evaluate scenarios in ordered. accurately determine ‘‘not applicable’’ which AUC were not available on a Comment: Commenters generally could be extremely difficult and regular basis so qualified PLEs can seek favored requiring qualified CDSMs to possibly inaccurate. In contrast, other to fill in these gaps. We agree with issue unique consultation identifiers, commenters believed this ability to commenters who believe the ‘‘not with a few commenters opposed to the produce a ‘‘not applicable’’ response applicable’’ response should be able to requirement until there is more was very important and suggested that occur in the background of some interoperability. Some of the such information should be provided qualified CDSMs, such as a qualified commenters in favor of the requirements back to the qualified PLE to encourage CDSM integrated within an EHR system. suggested that CMS should establish a future development of AUC to address We do not foresee any problems with standard taxonomy so the identifier that clinical scenario. Other commenters this method so long as documentation is issued would be truly unique and not questioned how this type of response produced as a result and the needed risk duplication across CDSMs. A from the CDSM would be implemented information is available to be provided subgroup of these commenters favored in a clinical workflow where the CDSM by the ordering professional to the this approach to allow for CMS to match is embedded within the EHR system. In furnishing professional. Medicare claims for advanced imaging those situations, they believed it was To allow flexibility for situations in services with their CDSM consultations. unnecessary to interrupt the workflow which the ordering professional plays a Response: Although we agree that of the ordering practitioner only to alert role in the determination of ‘‘not establishing a unique consultation them that there are no AUC available. applicable,’’ as well as those in which identifier with standard taxonomy could Response: Due to the statutory such determination is completely facilitate adding more robust data to requirement that AUC consultation automated within the CDSM, we have what is available on the Medicare claim, occur with each advanced diagnostic revised our proposals in we do not have the repository and imaging service ordered, we agree with § 414.94(g)(1)(v) to require qualified format for the identifiers that would be commenters that it is important for the CDSMs only to determine the extent to needed. We would further need to qualified CDSM to have the ability to which the applicable imaging service is establish how the identifier could be return a ‘‘not applicable’’ result. This consistent with specified applicable meaningfully appended to the Medicare requirement will apply to document AUC with the removal of language claim form. As such, it is not feasible at consistently that a consultation requiring the tool to make a this time for CMS to require qualified occurred and that no applicable AUC determination of ‘‘not applicable’’ when CDSMs to create such a narrowly were found. Exactly how this ‘‘not it does not contain a criterion that defined identifier. We are looking into applicable’’ response is formulated, we would apply to the consultation. options to determine possible future

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roles for that identifier. In the interim, Comment: Some commenters stated privacy and security framework in its we believe the requirement should that having a protocol in place to 2015 Edition Final Rule Health IT remain a functionality of qualified expeditiously remove dangerous or Certification. See the 2015 Edition Final CDSMs. Furthermore, we are not yet harmful AUC is not enough and that Rule (80 FR 62705, October 16, 2015) certain which standard taxonomy is best this could be accomplished very describing the privacy and security suited to the needs of this program. We quickly, even in a matter of a day. certification framework and specifying do, however, encourage stakeholders to Response: We agree that removing standards. In addition, the privacy and work together and welcome qualified potentially harmful AUC is extremely security standards set forth in the CDSMs to determine amongst important. At this time, we do not Health Insurance Portability and themselves if they should begin issuing believe we have enough information Accountability Act of 1996 (HIPAA) identifiers with an embedded taxonomy. about the types of CDSMs that will seek Privacy and Security Rules and enforced It would seem as though this could be qualification to know their abilities to by the Office for Civil Rights (OCR) are valuable in the future; having one react quickly in these situations. Again, potentially applicable. CDSMs would number that provides information we believe expeditious removal is also be subject to applicable state laws related to an individual CDSM critical but we are not able to select a and regulations regarding privacy and consultation. specific period of time at this point security. Comment: We received several because there may be large differences We are finalizing our proposals comments regarding how frequently a in capabilities when removing AUC without change, but will continue to qualified CDSM should be required to within one day, one week, or one consult with other agencies and update AUC content. Some commenters month. We expect that CDSMs will consider whether such standards may stated that 12 months to update content remove potentially harmful AUC as be specified in the future. We are finalizing our proposals was too long and we received the expeditiously as possible, and will without change, but will continue to suggestion of 3 months while others consider this issue for future consult with other agencies and were comfortable beginning with 12 rulemaking. Additionally, CDSMs may consider whether such standards may months, but once the program is more have differing components within their be specified in the future. established the time should be reduced. protocol to expeditiously remove potentially dangerous or harmful AUC Comment: Commenters favored the Other commenters suggested that requirement for CDSMs to provide adherence to the timing requirement is which could include more timely communications with users regarding aggregate feedback to ordering based primarily on the PLE and how the removal through, for example, professionals. Some commenters quickly after updating AUC the PLE banner notices or push notifications. suggested that CMS be prescriptive provides that updated content to the Comment: Commenters proposed that regarding the format and content of the CDSM. Commenters also noted that the CDSMs should contain AUC that reports providing feedback. time it takes to update a CDSM is based address the priority clinical areas at the Response: We do not agree that we on the format of the content delivered time they are qualified by CMS as should establish standards in feedback by qualified PLEs as some CDSMs will opposed to allowing 12 months for reporting to ordering professionals at still have much work to do to translate CDSMs to make them available. this time. We encourage qualified the qualified PLE provided content for Response: We disagree with this CDSMs and ordering professionals to use in the CDSM. comment and believe that, given the work together to determine the Response: We thank commenters for timing of the CY 2017 PFS final rule information that would be most pointing out that our 12-month when the first priority clinical areas will valuable. requirement for qualified CDSMs to be finalized, it is appropriate to allow Comment: We received several update AUC content was unclear with for 12 months from the date of the final comments regarding the proposed regard to when that 12-month period rule publication for qualified CDSMs to requirement to electronically store would begin. We agree that the time make available specified applicable CDSM consultation data for a minimum should begin when the qualified PLE AUC to address the priority clinical of 6 years. Some commenters stated that provides updated specified applicable areas. There would otherwise not be 6 years is an appropriate amount of time AUC content to the qualified CDSM and enough time for qualified CDSMs to to store this information while others have modified language in identify the needed specified applicable disagreed, stating that 6 years is overly § 414.94(g)(1)(vii). Such updates would AUC and make them available within burdensome. Some commenters are only take place if there are new or their mechanisms by March 1, 2017— seeking greater detail surrounding updated AUC content. We understand the deadline for the first round of CDSM exactly what data is required to be commenters who believe a 12-month applications seeking CMS qualification. stored while others state that period is too long to update specified Comment: We received comments consultation information should be AUC and wish to clarify that the time requesting additional clarification backed up by a third party or registry. begins when the specified applicable regarding the privacy and security These commenters were particularly AUC content is updated. We had standards that CDSMs must meet with concerned that data would be lost if a initially selected 12 months in an some commenters suggesting that CMS CDSM ceased operation. attempt to allow CDSMs to batch provide additional guidance through Response: Generally, we agree that updates and integrate them into the subregulatory vehicles. CDSM consultation data should be CDSM. We will consider shortening this Response: We are not the appropriate backed up to ensure that the data is not time period as the program continues regulatory authority to specify privacy lost; however, we do not agree that we and as CDSMs gain more experience. and security standards. However, there should be prescriptive at this time about We note that this 12-month requirement is existing guidance that we believe is how qualified CDSMs must go about for updating AUC is separate from the instructive. For those CDSMs contained ensuring their data is stored and requirement that qualified PLEs review within certified EHR technology, or for available for 6 years. We believe 6 years AUC at least every 12 months to confirm which certification is sought for is an appropriate amount of time across that the AUC reflect the latest clinical purposes of achieving ‘‘meaningful which ordering professionals will want evidence. use’’, ONC provided the applicable to assess their ordering patterns. In

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addition, as we discussed earlier our documentation must be generated each [email protected]. This process intent to require a unique consultation time an ordering professional consults a and timeline mirror the qualified PLE identifier, we believe there is the qualified CDSM and include a unique application and approval process and potential for consultation to be very consultation identifier generated by the timeline. As we did for qualified PLEs, valuable from a QI perspective if CDSM. we will post a list of all applicants that aggregated across qualified CDSMs, and • Modifications to AUC within the we determine to be qualified CDSMs to provided to qualified PLEs and possibly CDSM must comply with the following our Web site at https://www.cms.gov/ to CMS. Regarding the data elements timeline requirements: make available Medicare/Quality-Initiatives-Patient- that must be stored, we have not updated AUC content within 12 months Assessment-Instruments/Appropriate- required that qualified CDSMs collect from the date the qualified PLE updates Use-Criteria-Program/index.html by specific data fields. Therefore, at this AUC; and have a protocol in place to June 30. We proposed that all qualified time, we only have a more general expeditiously remove AUC determined CDSMs must reapply every 5 years and requirement that includes the storage of by the qualified PLE to be potentially their applications must be received by clinical, administrative and dangerous to patients and/or harmful if January 1 during the 5th year that they demographic information for each followed; and make available for are qualified CDSMs. It is important to consultation. consultation within 12 months of a note that, as with PLE applications, the Comment: A commenter suggested priority clinical area being finalized by application for qualified CDSMs is not that qualified CDSMs ensure that CMS specified applicable AUC that a CMS form; rather it is created by the ordering professionals have the reasonably address common and applicant. A CDSM that is specified as opportunity to access content for important clinical scenarios within any qualified for the first 5-year cycle educational purposes. This would allow new priority clinical area. beginning on July 1, 2017, would be ordering professionals to review • Meet privacy and security standards required to submit an application for information contained within the CDSM under applicable provisions of law. requalification by January 1, 2022. A without having to link that consultation • Provide to the ordering professional determination would be made by June with an order for advanced imaging aggregate feedback regarding their 30, 2022, and, if approved, the second services. consultations with specified applicable 5-year cycle would begin on July 1, Response: We agree that ordering AUC in the form of an electronic report 2022. professionals would benefit from being on at least an annual basis. An example of our proposed timeline able to use qualified CDSMs to further • Maintain electronic storage of for applications and the approval cycle their knowledge about the clinical, administrative, and is as follows: appropriateness of advanced imaging demographic information of each • Year 1 = July 2017 to June 2018. services. unique consultation for a minimum of 6 • Year 2 = July 2018 to June 2019. In response to public comments, we years. • Year 3 = July 2019 to June 2020. are finalizing the following • Comply with modification(s) to any • Year 4 = July 2020 to June 2021. • requirements at § 414.94(g)(1): requirements under paragraph (g)(1) of Year 5 = July 2021 to June 2022 • Make available specified applicable this section made through rulemaking (reapplication is due by January 1, AUC and its related supporting within 12 months of the effective date 2022). documentation. of the modification. We believe it is important for us to • Identify the appropriate use • Notify ordering professionals upon have the ability to remove from the list criterion consulted if the CDSM makes de-qualification. of specified qualified CDSMs a CDSM that we determine fails to adhere to any available more than one criterion d. Process for CDSMs To Become relevant to a consultation for a patient’s of the qualification requirements, Qualified and Determination of Non- including removal outside of the specific clinical scenario. Adherence • Make available, at a minimum, proposed 5-year cycle. We proposed to specified applicable AUC that We proposed that CDSMs must apply state under § 414.94(h) that, at any time, reasonably address common and to CMS to be specified as a qualified we may remove from the list of qualified important clinical scenarios within all CDSM. We proposed that CDSM CDSMs a CDSM that fails to meet the priority clinical areas identified in developers who believe their criteria to be a qualified CDSM or paragraph (e)(5) of this section. mechanisms meet the regulatory consider this information during the • Be able to incorporate specified requirements must submit an requalification process. Such applicable AUC from more than one application to us that documents determinations may be based on public qualified PLE. adherence to each of the requirements to comment or our own review and we • Determine, for each consultation, be a qualified CDSM. may consult with the National the extent to which the applicable We proposed to require in Coordinator for Health Information imaging service is consistent with § 414.94(g)(2) that CDSM developers Technology or her designee to assess specified applicable AUC. must submit applications to CMS for whether a qualified CDSM continues to • Generate and provide a certification review that document adherence to each adhere to requirements. or documentation at the time of order of the CDSM requirements. Applications We invited comments on how we that documents which qualified CDSM to be specified as a qualified CDSM could streamline and strengthen the was consulted; the name and national must be submitted by January 1 of a year approval process for CDSMs in future provider identifier (NPI) of the ordering to be reviewed within that year’s review program years. For instance, CMS may professional that consulted the CDSM; cycle. For example, as proposed the first consider a testing framework for CDSMs whether the service ordered would applications would be accepted from that would validate adherence to adhere to specified applicable AUC; the date of publication of the PFS final specific standards that enable seamless whether the service ordered would not rule until January 1, 2017. A incorporation of AUC across CDSMs. adhere to specified applicable AUC; or determination on whether the The following is a summary of the whether the specified applicable AUC applicants are qualified would be made comments we received on the process consulted was not applicable to the by June 30, 2017. Applications must be for CDSMs to become qualified and service ordered. Certification or submitted electronically to determination of non-adherence.

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Comment: Some commenters dates by which each requirement is elderly are incorporated into qualified requested that CMS review and approve expected to be met and information CDSMs. This commenter further qualified CDSMs more quickly. Some documenting how they intend to meet recommended CMS engage stakeholders commenters suggested the list of them. Applicants that meet most but not with expertise in geriatrics when qualified CDSMs be available by April all of the requirements at the time of selecting AUC and CDSMs. 1, 2017, rather than June 30, 2017, so as application will be considered only for Response: We are confident that to allow ordering professionals more preliminary qualification. qualified PLEs include relevant AUC time to prepare for implementation of CDSMs that receive preliminary within their libraries for the Medicare consulting and reporting requirements qualification must achieve full population and are supportive of on January 1, 2018. A commenter also qualification before the implementation multidisciplinary teams composed of suggested approval of certain types of of the consultation and reporting members with expertise even beyond systems, such as those intended requirements. As CDSMs move from those required in § 414.94(c)(1)(ii). As specifically for use in the emergency preliminary qualification to full indicated in the CY 2016 PFS final rule department, be prioritized. qualification upon meeting the with comment period (81 FR 71106), we Response: We recognize and requirements, CMS will update the encourage teams to be larger and appreciate the desire to more quickly information on the AUC Web site. For include other stakeholders. specify the first list of qualified CDSMs. those who are not able to achieve full Comment: Some commenters However, given the detailed review that qualification by the time of program requested that CMS make all CDSM will be dedicated to each application implementation, preliminary applications public. Commenters also along with agency internal processes, qualification will terminate and they suggested that CMS interact with qualification of CDSMs before June 30, will be eligible to reapply in the next applicants to communicate any 2017 is not feasible. As with qualified annual application cycle. For CDSMs questions or issues with the application PLE applications, which will be under that received preliminary qualification prior to making a qualification review at the same time, we intend to and are later converted to full determination. treat each applicant with the same level qualification status, their preliminary Response: We appreciate the interest of detail and attention and will not period will be included as part of their and contributions of all stakeholders as prioritize some over others. 5-year approval period. we implement this program and Comment: Some commenters cited We encourage CDSMs to strive to understand the desire to learn more insufficient time for CDSMs to meet all requirements by the March 1, about CDSM applicants; however, we incorporate requirements between the 2017 application submission deadline, will not systematically release this release of the final CDSM requirements, or as soon thereafter as possible, in information. To encourage stakeholder on or around November 1, 2016, and the order to receive full qualification status. interactions and to assist those seeking January 1, 2017 due date for qualified We believe this policy strikes a balance more information about qualified CDSM applications. These commenters between providing sufficient time for CDSMs, we intend to post basic requested that CMS delay the deadline CDSMs to prepare for full information about each qualified CDSM and accept applications later into the implementation, while also providing on the AUC Web site once the list is year for this first round of applicants. ordering professionals information on finalized. This should enable Due to the limited time between CDSMs’ qualification status to assist stakeholders to research and reach out finalization of CDSM requirements and them in making procurement decisions. directly to qualified CDSMs to learn the application deadline, another Comment: Commenters recommended more about the mechanism in support of commenter recommended that CDSMs that CMS require CDSMs to have making well informed choices moving be qualified based on their commitment already demonstrated successful forward. During the review process, we to support required functionality, rather implementation of the mechanism and intend to engage in the same type of than an attestation that the existing have established relationships in place dialogue with CDSM applicants as we functionality is fully implemented in a with multiple PLEs whose AUC already have with PLE applicants. During the CDSM. populate the mechanism. review of the first set of PLE Response: We recognize the challenge Response: We are finalizing section applications, we held at least one CDSM developers may have submitting 414.94(g)(2) to state that CDSM conference call with each applicant, applications by January 1, 2017, and developers must submit applications often held additional calls; and we also have extended the deadline only for the that document adherence to each CDSM exchanged numerous emails to ensure first round of applications to March 1, requirement in § 414.94(g)(1). As such, questions and concerns from both 2017. To this end, CDSMs will become we expect to receive applications from parties involved, CMS and the qualified if they provide evidence that CDSMs that have already established applicant, were addressed, discussed supports that they meet all CDSM these requirements and have experience and resolved as thoroughly as possible. requirements at the time of application. with adhering to them. We believe that We fully intend to engage in the same We further agree with commenters the final requirements largely address open and transparent process for CDSM that qualification should be available to the above comment; however, we applicants as well. We remind CDSM CDSMs that demonstrate a commitment require that qualified CDSMs be able to applicants that they may mark their to meeting the requirements. CDSM incorporate specified applicable AUC applications as containing proprietary applicants whose applications are from more than one qualified PLE. business information and we will received by March 1, 2017 but who are Therefore, we do not interpret this to protect that information to the full not able to provide evidence that all require that qualified CDSMs must extent permitted by law. requirements are met at the time of actually incorporate AUC from more Comment: Some commenters application will have the opportunity to than one qualified PLE in order to expressed concerns regarding CDSMs receive preliminary qualification. become qualified, provided concurrent that either fail to requalify after the first Applicants eligible for a preliminary requirements are also met. 5-year qualification period or are found qualification must demonstrate a Comment: A commenter suggested to no longer be adherent to CDSM commitment to meeting the CMS use the qualification process to requirements during the 5-year requirements by including expected ensure AUC specific to the needs of the qualification period. A commenter

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recommended that CDSMs be 1834(q)(1)(C) of the Act defines the under section 1834(q)(4)(A) and (B) of temporarily suspended before being applicable imaging services for which the Act on January 1, 2018, we disqualified. Other commenters AUC consultation is required as those requested feedback from the public to recommended that CMS ensure ordering for which there is at least one free include a discussion of specific professionals using these mechanisms mechanism available for AUC operational considerations that we not be penalized while they seek a new consultation. There is not a requirement should take into account and include in mechanism for consultation. One that every mechanism have a version such rulemaking. For example, we commenter stated that the CDSM be available for free. noted that commenters could consider required to notify ordering professionals In response to the comments, we have alternatives for reporting data on claims of such a disqualification. Other added language to § 414.94(g)(2)(ii) and for seeking exceptions, as discussed commenters requested that qualification delineating the process and below. We also requested information of CDSMs not be disrupted due to requirements to include preliminary on the barriers to implementation along standard technical updates to CDSMs qualification. The first application cycle this timeline that allows ordering and made during the 5-year qualification following the publication of this CY furnishing professionals to be prepared period. 2017 PFS final rule will be extended to to consult AUC and report consultation Response: We agree that CDSM March 1, 2017 for all CDSM applicants. information on the claims and whether qualification should not be disrupted As opposed to full qualification by separate rulemaking outside of the due to a standard update assuming no which CDSMs have documented how payment rule cycle would be preferred. changes are made to functionality that all requirements are met at the time of Under section 1834(q)(4)(B) of the result in non-adherence to the CDSM application, preliminary qualification Act, Medicare claims for applicable requirements in § 414.94(g)(1). We agree allows CDSMs to document, if not imaging services furnished in applicable that qualified CDSMs should be already met, how and when such settings can only be paid under the required to notify ordering professionals requirements are reasonably expected to applicable payment systems if certain in the event of disqualification and have be met. The preliminary qualification information is included on the claim added this requirement under period ends when we implement the including: which qualified CDSM was § 414.94(g)(1)(xii). consulting and reporting requirements consulted by the ordering professional Comment: Some commenters under this program as specified in for the service; whether the service, requested that CMS extend the amount § 414.94(g)(2)(ii)(B). We have also added based on the CDSM consultation, of time qualified CDSMs are qualified to § 414.94(g)(1)(xii) to require qualified adheres to specified applicable AUC, allow for more time to prepare for CDSMs to notify ordering professionals does not adhere to specified applicable requalification. Other commenters upon de-qualification. AUC or whether no criteria in the CDSM recommended that CMS shorten the were applicable to the patient’s clinical e. Consultation by Ordering Professional qualification period to better align with scenario; and, the national provider and Reporting by Furnishing the pace of change to EHR security and identifier (NPI) of the ordering Professional interoperability standards with those of professional. This section further allows CDSMs. Although we continue to aggressively payment for these services only if the Response: We believe that a 5-year move forward to implement this AUC claim contains such information qualification period for qualified program, ordering professionals will not beginning January 1, 2017. To develop CDSMs is an appropriate timeframe at be expected to consult AUC using and operationalize a meaningful this time. As the AUC program evolves, qualified CDSMs by January 1, 2017. At solution to collecting new AUC we could revisit this requirement the earliest, the first qualified CDSM(s) consultation-related information on the through future rulemaking should we will be specified on June 30, 2017. We claims, we must diligently evaluate our find that a modification is warranted. anticipate that some ordering options taking into account the vast Comment: Some commenters professionals could be able to begin number of claims impacted and the suggested and supported CMS consulting AUC through qualified limitations of the legacy claims developing a testing framework for CDSMs very quickly as some may processing system. Additionally, in the CDSMs, focusing especially on already be aligned with a qualified case of advanced imaging services, interoperability, and/or convene CDSM. related claims are already required to stakeholders for the purpose of creating We expect that furnishing append certain HCPCS modifiers and G such a framework. professionals will be required to begin codes for purposes of proper payments. Response: We will continue to reporting January 1, 2018. This In the recent implementation of section explore opportunities to develop a timeframe is necessary to allow time for 218(a) of the PAMA, we established a testing framework for qualified CDSMs ordering practitioners who are not HCPCS modifier for CT services with ONC and other standards groups. already aligned with a qualified CDSM rendered on machines that do not meet Comment: Several commenters to research and evaluate the qualified an equipment standard. It is important requested that CMS provide details on CDSMs so they may make an informed that we understand and evaluate how the free CDSM tool required under decision. While there will be further the additional requirements for AUC section 218(b) of the PAMA. Another rulemaking next year, we are reporting would impact the information commenter stated that all qualified announcing this date because the that is already required for advanced CDSMs should have a free version agency expects physicians and other imaging services. Moving too quickly to available. stakeholders/regulated parties to begin satisfy the reporting requirement could Response: As stated in the CY 2017 preparing themselves to begin reporting inadvertently result in technical and PFS proposed rule, the Secretary did not on that date. We will adopt procedures operational problems that could cause propose to establish any free CDSM at for capturing this information on claims delays in payments. this time. Therefore, a free CDSM would forms and the timing of the reporting Section 1834(q)(4)(C) of the Act need to apply for qualification just as requirement through PFS rulemaking for includes exceptions that allow claims to any other CDSM. We disagree that all CY 2018. be paid even though they do not include qualified CDSMs must have a free As we expect to implement the AUC the information about AUC consultation version available as section consultation and reporting requirements by the ordering professional. We believe

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that, unless a statutory exception not allow reporting by line item. Others Response: Although we have been applies, an AUC consultation must take noted that the UB04/837i form would actively working with components place for every order for an applicable allow providers to report individual line throughout the agency to develop and imaging service furnished in an item services, but limited space on the establish claims processing instructions applicable setting and under an form prevents specific line items from and reporting details for the AUC applicable payment system. We further being linked to other information like an program, given the complexities of the believe that section 1834(q)(4)(B) of the ordering professional, diagnosis code or Medicare legacy claims processing Act accounts for the possibility that authorization code to each item. systems and the extensive interactions AUC may not be available in a Many commenters recommended the necessary to properly develop and particular qualified CDSM to address use of a specific code issued by the implement these requirements, we every applicable imaging service that CDSM that would include alphanumeric intend to include them in rulemaking might be ordered; and thus, the characters to represent each of the for the CY 2018 PFS and not earlier furnishing professional can meet the required elements for reporting. through subregulatory processes or requirement to report information on Commenters suggested that this code alternate rulemaking cycles. While we the ordering professional’s AUC could be placed in field 23 (prior appreciate that CDSMs could benefit consultation by indicating that AUC is authorization field) of the 837P claim from having information on claims not applicable to the service ordered. form. Another commenter reporting requirements, we note that the We are considering the mechanisms recommended placing a unique information to be submitted on the for appending the AUC consultation identifier in field 19 of the 1500 form. claim is identified in section information to various types of Two other suggestions included placing 1834(q)(4)(B) of the Act and CDSMs may Medicare claims and expect to develop the unique identifier on both the begin preparing themselves for reporting requirements for appending such professional component and technical the following items: (1) Which qualified information in the CY 2018 PFS component (or OPPS) claims, CDSM was consulted by the ordering rulemaking process. We encouraged identifying field 63 on the 837i form, or professional for the service; (2) whether stakeholders interested in sharing submitting a ‘‘dummy’’ claim with the the service, based on the CDSM feedback related to reporting and claims unique identifier to accompany all consultation, adheres to specified processing to do so as part of the claims for applicable imaging services applicable AUC, does not adhere to comment period to inform this final furnished. specified applicable AUC or whether no rule. We were particularly interested in A commenter suggested that the criteria in the CDSM were applicable to receiving feedback on, for example, reporting requirement should apply to the patient’s clinical scenario; and (3) whether the information should be providers who submit claims on a 155/ the NPI of the ordering professional. We collected using HCPCS level II G codes 837P because line item reporting is remind CDSMs that § 414.94(g)(1)(vi) or HCPCS modifiers. available. We also received a comment requires qualified CDSMs to generate The following is summary of the suggesting CMS could work with X12 to and provide a certification or comments we received on consultation add the data to the claim more quickly documentation at the time of order that by ordering professionals and reporting through the K3 segment of the electronic documents which CDSM was consulted; by furnishing professionals. claim, which is reserved for new data the name and NPI of the ordering Comment: In response to our request required under legislation and professional that consulted the CDSM; for information about how to reflect regulation. A commenter suggested that whether the service ordered would AUC consultation on the Medicare the reporting requirements use a adhere to specified applicable AUC or claim form, we received extensive framework allowing for regular feedback whether the specified applicable AUC feedback. In particular, we requested to ordering professionals regarding their consulted was not applicable to the feedback on using HCPCS modifiers or ordering patterns. Another commenter service ordered. The information HCPCS Level II G codes to identify the suggested a simple attestation that such qualified CDSMs must document required information about the information would be available to CMS encompasses information required for consultation on the Medicare claim upon request. A commenter claims reporting under section form. Some commenters recognized that recommended that codes be modified to 1834(q)(4)(B) of the Act. these options for reporting were feasible reflect additional costs of CDSM Comment: Some commenters and could capture all information services. requested that CMS rigorously test the needed for the claim. Some commenters Response: We appreciate the claims reporting requirements or noted that the number of modifiers extensive and thoughtful information facilitate a workgroup to engage in this possible on a claim form was limited provided in response to our request. testing before reporting requirements are and questioned whether all information These comments will be instrumental in established and effective. One required for reporting could be captured our development of claims reporting commenter recommended that CMS by modifies. Some commenters noted requirements. have a way to account for orders that that it would be difficult for G codes to Comment: Many commenters may appear to be appropriate based on include all required information for requested the release of claims reporting AUC consultation but are actually reporting which would necessitate information as quickly as possible and duplicative and redundant. multiple G codes and result in greater before rulemaking in CY 2017. Multiple Response: Thank you for this administrative burden for reporting. commenters insisted that reporting suggestion. Some commenters noted that requirements be provided before CDSMs Comment: A commenter requested modifiers and G codes were not ideal apply for qualification as they need this that CMS develop an appeals process, solutions and provided alternate information to design their mechanisms and share that information in a timely suggestions. Several commenters and comply with the program manner. addressed use of the UB04/837i for requirements. Some commenters Response: Appeal rights will continue reporting. Some noted that such requested responses to questions about to apply to claims after implementation proposals would not work when more precisely which codes will be required of this program. Changes to the appeals than one test is performed on the same and their specific location on the claim process are outside the scope of this date of service because the form does form. rule.

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Comment: Some stakeholders have imaging services would still qualify for Meaningful Use significant hardship requested CMS provide opportunities to an exception. To meet the exception for exception under § 495.102(d)(4)(iv)(C) involve and accept feedback from all an emergency medical condition as as an exception for purposes of the AUC stakeholders in the development of the defined in section 1867(e)(1) of the Act, consultation requirement. Therefore, claims reporting requirements. One the clinician only needs to determine ordering professionals with a primary commenter recommended that CMS that the medical condition manifests specialty of anesthesiology, radiology or create an agency-wide task force to work itself by acute symptoms of sufficient pathology will not be categorically with claims standards organizations to severity (including severe pain) such excepted from AUC consultation address all demands that will be placed that the absence of immediate medical requirements. on the claim form due to AUC reporting. attention could reasonably be expected We believe there is substantial Response: We appreciate the interest to result in: placing the health of the overlap between the eligible by stakeholders in contributing to the individual (or a woman’s unborn child) professionals that would seek a development of these requirements. We in serious jeopardy; serious impairment hardship exception under the EHR are happy to receive correspondence to bodily functions; or serious Incentive Program and those ordering and feedback at any time through the dysfunction of any bodily organ or part. professionals that would seek a AUC program email box ImagingAUC@ Orders for advanced imaging services hardship exception under the AUC cms.hhs.gov, and we encourage for beneficiaries with an emergency program and, as such, this proposal stakeholders to provide information to medical condition as defined under would be administratively efficient. us as early as possible to help inform section 1867(e)(1) of the Act are Using an existing program is the most our proposals for requiring claims excepted from the requirement to efficient and expeditious manner to reporting starting January 1, 2018. We consult AUC. We intend through the CY implement the significant hardship will continue to work with stakeholders 2018 PFS proposed rule to propose exception under the Medicare AUC as we develop reporting requirements. more details around how this exception program. We also believe it is the only We appreciate all information shared will be identified on the Medicare administratively feasible option for a by commenters. We will use this claim. national significant hardship feedback to inform CY 2018 rulemaking The second exception is under section identification process that can be where we expect to establish the 1834(q)(4)(ii) of the Act for applicable implemented by January 1, 2018, though requirements for reporting under the imaging services ordered for an we intend to revisit this option for years AUC program. inpatient and for which payment is after 2018 as the current EHR Incentive f. Exceptions to Consulting and made under Medicare Part A. We Program payment adjustment is set to Reporting Requirements proposed to codify this exception in expire after the 2018 payment new § 414.94(i)(2). While we are adjustment year as the Merit-Based Section 1834(q)(4)(C) of the Act including this exception consistent with Incentive Payment System takes effect. provides for certain exceptions to the statute, we note that if payment is made In addition, below we discuss AUC consultation and reporting under Medicare Part A, the service considerations for a supplemental requirements under section would not be paid under an applicable process to account for hardships for 1834(q)(4)(B) of the Act. First, the payment system, such that the AUC ordering professionals that are not statute provides for an exception under consultation and reporting requirements eligible to apply for a significant section 1834(q)(4)(C)(i) of the Act where under § 414.94 would never apply. hardship under the EHR Incentive an applicable imaging service is ordered The third exception is under section Program (for example, non-physician for an individual with an emergency 1834(q)(4)(iii) of the Act for applicable practitioners) and ordering professionals medical condition as defined in section imaging services ordered by an ordering that incur a significant hardship outside 1867(e)(1) of the Act. We believe this professional who the Secretary of the EHR Incentive Program exception is warranted because there determines, on a case-by-case basis and application deadline. can be situations in which a delay in subject to annual renewal, that The criteria for significant hardships action would jeopardize the health or consultation with applicable AUC under the EHR Incentive Program relate safety of individuals. Though we believe would result in a significant hardship, to insufficient internet connectivity, they occur primarily in the emergency such as in the case of a professional extreme and uncontrollable department, these emergent situations practicing in a rural area without circumstances that prevent the EP from could potentially arise in other settings. sufficient Internet access. We proposed becoming a meaningful EHR user, Furthermore, we recognize that most to codify this exception in new practicing for less than 2 years, encounters in an emergency department § 414.94(i)(3) by specifying that ordering practicing at multiple locations with the are not for an emergency medical professionals who are granted a inability to control the availability of condition as defined in section significant hardship exception for Certified EHR Technology, lack of face- 1867(e)(1) of the Act. purposes of the Medicare EHR Incentive to-face or telemedicine interaction with We proposed to provide for an Program payment adjustment under patients or a primary specialty exception to the AUC consultation and § 495.102(d)(4)(i), (ii), or (iii)(A) or (B) of designation of anesthesiology, radiology reporting requirements under our regulations would also be granted a or pathology. We believe that most of § 414.94(i)(1) for an applicable imaging significant hardship exception for these criteria would be relevant to service ordered for an individual with purposes of the AUC consultation demonstrate a significant hardship for an emergency medical condition as requirement. We proposed, to the extent ordering professionals to consult AUC. defined in section 1867(e)(1) of the Act. technically feasible, that the year for Regarding hardship exceptions for For example, if a patient, originally which the eligible professional is certain specialty designations, based on determined by the clinician to have an excepted from the EHR Incentive Medicare claims data for advanced emergency medical condition prior to Program payment adjustment is the imaging services from the first 6 months ordering an applicable imaging service, same year that the ordering professional of 2014, approximately 1.2 percent of is later determined not to have had an is excepted from the requirement to those claims were for advanced imaging emergency medical condition at that consult AUC through a qualified CDSM. services that had been ordered by a time, the relevant claims for applicable We proposed not to adopt the professional with one of the three

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primary specialty designations. While categorically receive significant non-physician practitioners) with a their combined ordering volume is hardship exceptions under the EHR significant hardship to seek such small, we do not believe that categorical Incentive Program, real-time hardships exceptions because the EHR Incentive exclusion of certain specialties of which that arise during a year, and ordering Program is limited to physicians. the practitioner selected as their professionals that are not eligible to Response: We disagree with the primary specialty designation for apply using the EHR Incentive Program commenters suggesting that we replicate Medicare enrollment would necessarily significant hardship exception process under the AUC program all hardship be appropriate under the AUC program. and need to seek a significant hardship exceptions under the EHR Incentive Since eligible professionals in these exception for the purposes of the AUC Program, including exceptions for three three specialties are categorically program. We believe this would involve medical specialty designations. We do excepted from the EHR Incentive only a small number of ordering not believe our program is authorized to Program payment adjustment, few of professionals. To the extent technically except ordering professionals based on them would have applied for an feasible, some possibilities for their specialty. Therefore, we have exception on the other grounds. implementing such hardship exceptions decided at this time to proceed with Therefore, we must consider another may include Medicare Administrative finalizing the significant hardship mechanism to evaluate whether Contractors granting hardships on a exceptions under the AUC program as ordering practitioners with these case-by-case basis or establishing proposed. We remind all commenters medical specialties experience a another mechanism to allow for self- that this proposal included a significant significant hardship for purposes of the attestation of a significant hardship for hardship exception for those ordering AUC program. a defined period of time (for example, professionals that can demonstrate We understand that there are a calendar quarter or a calendar year). inability to control the availability of differences between the purpose and We intend to propose a process in the Certified EHR Technology. timing of significant hardship CY 2018 PFS proposed rule. We agree with the commenters that exceptions for the EHR Incentive We invited the public to comment on the agency need not create a separate Program and the Medicare AUC our proposal for ordering professionals process for granting a significant program. Foremost, a significant granted a hardship exception for the hardship exception where practitioner hardship under the EHR Incentive EHR Incentive Program for payment overlap is available but we understand Program is generally based on a adjustment year 2018 to also be granted that a separate process will need to be hardship that occurred in a prior period, a hardship exception to the Medicare established to handle significant impacting meaningful EHR use that AUC program for those years. We hardship requests from non-physician would affect payments in a subsequent proposed that the year the practitioner practitioners that order advanced calendar year. For example, a is excepted from the EHR Incentive imaging tests as they are not currently professional that submits an application Program payment adjustment is the included in the EHR Incentive Program. in March 2017 and qualifies for the same year that the practitioner would be However, we remind all commenters hardship exception under the EHR excepted from consulting AUC. that we intend to revisit this option for Incentive Program would be exempt The following is a summary of the years after 2018 as the current EHR from the EHR payment adjustment for comments we received on the proposed Incentive Program payment adjustment calendar year 2018. Although significant exceptions to consulting and reporting is set to expire after the 2018 payment hardship exceptions for the EHR requirements: year as the Merit-Based Incentive payment adjustment year generally are Comment: Most commenters Payment System takes effect. based on the existence of a hardship in concurred that if an eligible professional Comment: A few commenters urged a prior period, we believe it would be is exempt from the EHR Incentive CMS to consider additional exceptions appropriate for these professionals to Program payment adjustment, then the for ordering professionals that may also qualify for a significant hardship ordering professional should also be encounter hardship in attempting to exception for purposes of the AUC exempt from AUC consultation for consult of specified applicable AUC for consultation requirement during applicable imaging services. an applicable imaging service. The calendar year 2018. It is also our best, Commenters generally were concerned additional exceptions submitted by most efficient, administratively feasible that CMS proposed a more limited set commenters included (1) ordering means of determining significant of hardship exceptions than what is professionals who lack control over the hardships for ordering professionals for currently available under the EHR availability of CEHRT for more than 50 CY 2018. Incentive Program. For example, we did percent of patient encounters, such as in We also recognize the possibility that not propose to allow certain medical the case of some hospital-based an ordering professional could suffer a specialty designations to be exempt physicians; (2) any physician who does significant hardship during the AUC from CDSM consultations even though not have access to a low-cost integrated program year, and therefore, is they are automatically exempted from CDSM; (3) ordering professionals within immediately unable to consult AUC. In the EHR Incentive Program. One a small practice or with a low-volume addition, while again we believe there is commenter observed that for the of advanced imaging services; (4) those significant overlap, there may be purposes of the AUC program only some who participate in either alternative circumstances where an ordering EHR Incentive Program hardships may payment models or accountable care professional is not considered to be an be applicable. One commenter organizations; (5) physicians who eligible professional for purposes of the suggested that the operation of this practice in a patient-centered medical Medicare payment adjustmentsunder exceptions process be automatic for home; (6) any professional using a the EHR Incentive Program (for those already enrolled in the EHR qualified CDSM that is either example, an ordering professional that Incentive Program hardship exception. disqualified or not re-qualified; (7) any is not a physician). We solicited Another commenter noted their group or institution in the process of feedback from commenters regarding observation that while making the EHR implementing a new electronic medical processes that could be put in place to Incentive Program operational for the record and billing system; (8) clinicians accommodate ordering professionals AUC program, it may not allow all who receive a 0% weighting for the with primary specialties that ordering professionals (physicians and advancing care information performance

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category under the MIPS; and (9) claims condition is that the ordering practitioners, beneficiaries, AUC for patients in clinical trials. professional may not be in a position to developers, and CDSM developers. It is Response: We appreciate the make such a determination. As an for these reasons we proposed to additional feedback received about alternative recommendation, one continue a stepwise approach, adopted additional categories of hardship that commenter suggested that a ‘‘reasonable through notice and comment could be excepted from the consulting person’’ should make the determination rulemaking. We proposed this second and reporting requirements. Although as to whether an emergency medical component to the program to specify we did not propose additional hardship condition exists. The commenter states qualified CDSMs, identify the initial list categories outside of the EHR Incentive that the ‘‘reasonable person’’ standard is of priority clinical areas, and establish Program in this year’s rule, we will take used by private health insurance requirements related to CDSMs, as well these comments into account as we coverage in emergency situations and as consulting and reporting exceptions. consider hardship exceptions in the CY would include scenarios when the However, we also recognize the 2018 PFS proposed rule. patient himself has a reasonable belief importance of moving expeditiously to Comment: Other commenters were that he has an emergency medical accomplish a fully implemented not concerned with the determination of condition. A few commenters disagreed program. Under this proposal, the first the hardship exceptions for ordering as to how many encounters in an list of qualified CDSMs will be posted professionals, and instead raised emergency department are outside the no later than June 30, 2017, allowing concerns that a furnishing professional definition of an emergency medical ordering professionals to begin aligning may not be able to accurately determine condition. themselves with a qualified CDSM. We whether an ordering professional Response: We do agree that expect that furnishing professionals will qualifies for a hardship exception. exceptions granted for an individual be required to begin reporting AUC Another commenter proposed a with an emergency medical condition information starting January 1, 2018, potential solution to the other include instances where an emergency and will address this requirement commenters’ concerns and medical condition is suspected, but not through PFS rulemaking for CY 2018, recommended to CMS that any ordering yet confirmed. This may include, for including how to report that professional with a hardship exception example, instances of severe pain or information on claims. should have a special NPI designation. severe allergic reactions. In these In summary, we proposed definitions Other commenters did not propose such instances, the exception is applicable of terms and processes necessary to mechanisms and encouraged CMS to even if it is determined later that the implement the second component of the address this concern in future patient did not in fact have an AUC program. We invited the public to rulemaking. emergency medical condition. We submit comments on these proposals. Response: We will work internally to appreciate the offer from stakeholders to We were particularly seeking comment consider this concern and may address work with us to determine how best to on the proposed priority clinical areas it in future rulemaking. capture this exception on claims. We do and the requirements that must be met Comment: Commenters generally not have a reason at this time to believe by CDSMs to become qualified. We supported exceptions to AUC that a categorical exception granted to believe the proposed requirements for consultation and reporting requirements emergency departments would foster qualified CDSMs will allow for for applicable imaging services ordered inappropriate use of advanced imaging flexibility so mechanisms can continue for an individual with an emergency services. However, we believe such a to reflect innovative concepts in medical condition; however, there was categorical exception would not be decision support and develop customer- disagreement on how best to implement consistent with the statutory driven products to ultimately provide this exception. Commenters stated that requirement under section information to the ordering professional ambiguity regarding whether an 1834(q)(4)(C)(i) of the Act, which is in such a manner that will maximize emergency medical condition is present framed in terms of individual services. appropriate ordering of advanced could cause a delay in the delivery of In response to the comments, we have diagnostic imaging while seamlessly emergency services to patients and made no changes to the proposed integrating into workflow. As the requested clarification on the exceptions and have finalized our stakeholders continue to move to a application of the AUC program in proposals. place of consensus-based standards emergency departments and exceptions 6. Summary deemed ready for deployment, we may for certain emergency services. A few become more prescriptive in future commenters offered an alternative Section 1834(q) of the Act includes requirements for CDSMs. We also exception from AUC consultation for all rapid timelines for establishing a solicited comment on the exceptions to emergency departments. One Medicare AUC program for advanced the requirements to consult applicable commenter proposed a simple diagnostic imaging services. The AUC using CDSMs. attestation process that does not further number of clinicians impacted by the The following is a summary of the divert physician time away from scope of this program is massive as it other of the comments we received patients. Some commenters expected will apply to every physician or other specific to the Medicare AUC program that to operationalize this exception, practitioner who orders or furnishes but not directly related to our proposals. any service with revenue codes in the applicable imaging services. This Comment: Overall, commenters range of 045X or 0516 or place of service crosses almost every medical specialty expressed their general support for the code 23 would be exempt. Other and could have a particular impact on use of AUC in diagnostic imaging. commenters recognized and remarked to primary care physicians since their Response: We appreciate the support CMS that encounters that may occur scope of practice can be quite broad. and stakeholder involvement outside the emergency department may We continue to believe the best throughout the implementation process. also be ordered for an individual with implementation approach is one that is Comment: Most commenters an emergency medical condition. diligent, maximizes the opportunity for supported our staged approach to Another commenter explained that one public comment and stakeholder implementing this program and most problem with creating an exception for engagement, and allows for adequate commenters supported the longer time individuals with an emergency medical advance notice to physicians and period before requiring ordering

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professionals to consult AUC in MIPS rather than creating a standalone benefit management (RBM) companies qualified CDSMs and furnishing AUC program. cannot be involved in any way with professionals to report consultation Response: We will continue to qualified PLEs and in the development information on claims. Many explore avenues for alignment of the of specified applicable AUC. Some commenters requested additional time AUC program and the Quality Payment commenters further stated that RBMs to comply with the consultation and Program. CMS issued a final rule with should not be involved because they do reporting requirements under this comment period to implement the QPP, not use the same rigorous AUC program. Some recommended an including MIPS. The rule can be development process as medical additional 6-months until July 1, 2018, accessed at https://qpp.cms.gov/ specialty societies, clinicians and and others encouraged waiting until education. providers and are focused on limiting 2019 noting that providers will not have Comment: Some commenters utilization rather than assisting time to choose a CDSM once the requested that CMS confirm that providers in making optimal medical qualified CDSM list is posted by June consulting and reporting will be decisions. Other commenters requested 30, 2017. Many commenters urged us to required starting January 1, 2018, and that we better explain the third party allow for 18 months between the release stated that due to the availability of interaction permissible between of the list of qualified CDSMs and the CDSMs and AUC, this start date is qualified PLEs and RBMs. start of the reporting requirement. reasonable and feasible. One commenter Response: As finalized in the CY 2016 Commenters also supported additional expressed concern with the January 1, PFS final rule with comment period, the time for implementation by stating that 2018 implementation date for definition of PLE refers to organizations the program implementation date consultation and reporting due to the comprised primarily of providers or should be dictated by the availability of cost and patient harm resulting from practitioners who, either within the CDSMs, their integration into EHR inappropriate imaging. The commenter organization or outside of the systems, physician readiness, and urged CMS to work diligently to organization, predominantly provide sufficient testing. One commenter implement these requirements as direct patient care. This definition of suggested, in the absence of additional quickly as is feasible. Another PLE includes health care collaboratives time, we could ask physicians to commenter suggested using a pilot and other similar organizations such as annually attest, subject to audit, that period or starting voluntary consulting the National Comprehensive Cancer they are consulting a CDSM prior to and reporting on January 1, 2018, during Network and the High Value Healthcare ordering relevant advanced imaging which information on the Medicare Collaborative. We further clarify that services. claim would not be considered for qualified PLEs may collaborate with Response: We appreciate the outlier determinations. Some third parties that they believe add value challenges that the aggressive timeline, commenters also suggested that the to their development of AUC, provided established in section 218(b) of the program first start with health systems such collaboration is transparent. It is PAMA, creates for all of us, and have and larger group practices and be rolled our expectation that PLEs will develop taken steps to alleviate these challenges out to smaller settings over time. or modify AUC consistent with all by phasing in components of this Response: We continue to expect that regulations in § 414.94(c)(1). If program as necessary for meaningful furnishing professionals will be commenters are interested in learning implementation. We continue to expect required to begin reporting January 1, more about the AUC development that furnishing professionals will be 2018, and will address this requirement process of any individual qualified PLE, required to begin reporting January 1, through PFS rulemaking for CY 2018. then we remind the commenters that 2018, and will address this requirement Comment: Some commenters qualified PLEs disclose the parties through PFS rulemaking for CY 2018. requested that CMS continue to external to the organization when such Comment: One commenter cautioned implement the AUC program through parties have involvement in the AUC CMS to ensure ordering professionals rulemaking separate from the PFS so as development process. and furnishing professionals are not to establish more programmatic Comment: Another commenter noted penalized due to phase-in of the components sooner, particularly related that the definition of qualified PLE consulting and reporting requirements to consulting and reporting restricts independent, evidence-based under the AUC program or any other requirements and how this information content solutions from inclusion. The quality program. will be documented on Medicare commenter further requested that we Response: We do not foresee any claims. Other commenters stated that remove language from the preamble situations where professionals would be the PFS is the appropriate cycle for they believe adds criteria to the penalized as a result of our decision to establishing the AUC program and is definition of PLE. Specifically they phase in the consulting and reporting important to ensure all stakeholders are requested removal of language requirements. aware of proposals and have the discussing expectations of qualified Comment: Several commenters noted opportunity to comment. PLEs ‘‘to have sufficient infrastructure, that practitioners will have to comply Response: We believe that the PFS is resources, and the relevant experience with the requirements of the Merit- the most appropriate rulemaking vehicle to develop and maintain AUC. . .’’ and Based Incentive Payment System (MIPS) for implementing the AUC program and identified this language as an ‘‘evolving (under the Quality Payment Program) at will continue to use the PFS annual definition’’ that is ‘‘highly problematic’’ the same time they will have to comply rulemaking process to establish future and requested revision to more with the AUC consultation and components. accurately reflect the language in the CY reporting requirements which is overly Comment: Many comments were 2016 PFS final rule with comment burdensome. Some commenters submitted specific to qualified PLEs. period. recommended alignment of the AUC Commenters requested both clarification Response: We are not changing the program with the Quality Payment and modifications to the definition of requirements of qualified PLEs and Program requirements so as not to PLE finalized through rulemaking in the disagree that the cited language adds further increase burden on practitioners, CY 2016 PFS final rule with comment criteria to the existing definition of PLE. and one commenter recommended period. Specifically, some commenters The language in the background section alignment of the AUC program with requested that we clarify that radiology of the CY 2017 PFS proposed rule

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referenced above is not intended to protect that information to the fullest Some commenters encouraged us to build upon or provide more criteria to extent permitted by law. focus outlier identification where wide the definition of PLE in § 414.94(b). In Comment: In response to our request variance in appropriate imaging patterns fact this language was being used to for feedback regarding how appears. Commenters also describe the requirements of qualified appropriateness ratings provided by recommended that ordering PLEs under § 414.94(c)(1) and not to CDSMs could be interpreted and professionals should be made aware of further explain the definition of PLE. recorded for the purposes of this ordering patterns before being subject to Comment: Some commenters program, we received numerous prior authorization under the AUC requested that we provide more comments. Commenters identified program. information about qualified PLEs and several ways appropriateness ratings are Some commenters opposed a strict facilitate interactions between qualified presented in CDSMs including: binary application of all priority clinical areas PLEs and other stakeholders perhaps in yes, appropriate or no, not appropriate; for the purposes of outlier the form of a tool or resource containing color coded using green for appropriate, identification. Commenters requested more detailed information or by yellow for may be appropriate and red that only ordering professionals with coordinating a meeting for qualified for not appropriate; numerical ranges ordering patterns significantly PLEs and other stakeholders to interact. from 1 through 9/10 where 1–3 are not misaligned with AUC be subject to prior Response: We do not believe we are appropriate, 4–6 may be appropriate authorization. Commenters also best equipped to facilitate stakeholder and 7–9/10 are appropriate, and a requested criteria used to make outlier interactions as suggested; however, we combination of color coded and determination be adjusted over time to will continue to build out the numerical ratings. Commenters also allow for innovation in ordering. One information on the AUC Web site to used varying terminology including not commenter requested that ordering enable stakeholders to research and appropriate, rarely appropriate, may be professionals not be subject to AUC reach out directly to qualified PLEs to appropriate, usually appropriate, consultation and prior authorization at learn more about their AUC libraries indicated and not indicated. the same time. Response: We appreciate the and processes. Commenters recommended that extensive and thoughtful information Comment: A commenter requested appropriateness ratings that are not in a provided in response to our request. We that we wait to implement the AUC binary form need to be translated into binary values, only values equivalent to will consider these comments when program until a broader list of qualified not appropriate equal no and values determining how to operationalize the PLEs is available. equal to may be appropriate and outlier determination component of this Response: On June 30, 2016, a list of appropriate equal yes. Some program. 11 qualified PLEs was posted to the commenters recommended that CDSMs Comment: Some commenters AUC Web site (https://www.cms.gov/ be required to present appropriateness recommended that we require data Medicare/Quality-Initiatives-Patient- ratings in binary formats as this submission to CMS directly or to a third Assessment-Instruments/Appropriate- information will be required on the party registry. Such reporting would Use-Criteria-Program/index.html). claim, while others stated that a binary enable professionals to track ordering Together these qualified PLEs include a appropriateness rating should not be patterns, especially in relation to large volume of AUC and we do not required. Some commenters priority clinical areas and subsequent agree that it is necessary to wait to recommended CMS define standards for outlier determinations. implement the program to further appropriateness ratings. Response: We will consider this expand the list of qualified PLEs. Response: We appreciate the recommendation as we implement the Furthermore, we expect more extensive and thoughtful information future components of this program. applications from organizations seeking provided in response to our request. Comment: Several comments focused specification as qualified PLEs for 2017 These comments will be instrumental in on the communication for the image so we expect the list to grow again in operationalizing the AUC program. order from ordering professionals to June of 2017. Comment: We received numerous furnishing professionals. Some Comment: Several commenters comments addressing the future outlier commenters requested we include requested that all applications determinations. Many commenters requirements in the final rule, and some submitted by organizations seeking agreed with using priority clinical areas requested that we require electronic qualification as a PLE be made public. to inform the outlier identifications. communications. Commenters Response: We appreciate the interest Other commenters questioned how we recommended that the furnishing and contributions of all stakeholders as will be able to identify outliers starting professional be allowed to consult we implement this program and in 2020 when priority clinical areas specified applicable AUC through a understand the desire to learn more include AUC that conflict with one qualified CDSM if the ordering about qualified PLEs, however we will another. Some commenters suggested professional fails to provide not systematically release this that outlier determinations be based consultation information to the information. To encourage stakeholder upon the percentage of orders for which furnishing professional to avoid claims interactions and to assist those seeking AUC consultation resulted in a denials. Others suggested that more information about qualified PLEs, recommendation of 1–3 (based on the 1– furnishing professionals be able to we posted general information about 9 appropriateness level determinations). identify whether an ordering each qualified PLE on the AUC Web More specifically, ordering professional is considered an outlier site. We intend to add more information professionals ‘‘with an ordering pattern under the AUC program and others about each qualified PLE to the AUC in ‘Red Rate’ percentage two standard recommended we develop a verification Web site which should enable deviations higher than the median mechanism that would be required of stakeholders to research and reach out should be considered outliers.’’ One the ordering professional. directly to qualified PLEs. We remind commenter suggested that the outlier Response: We are not establishing PLE applicants that they may mark their calculation use AUC compliance for requirements regarding the applications as containing proprietary priority clinical areas as the numerator communication of the imaging order business information and we will and total AUC as the denominator. from the ordering professional to the

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furnishing professional. These While other commenters stated that the the additional administrative burden professionals currently send and receive added burden is outweighed by the cost this program will place on providers. orders successfully via various vehicles savings and quality improvements Commenters also requested that we (within EHR, fax, etc.), and we do not resulting from a properly implemented ensure that AUC consultations do not believe it is appropriate at this time to AUC program and is significantly less interfere with physicians’ clinical place further constraints or than traditional prior authorization judgment when treating patients. requirements on the systems for programs. Response: We disagree with the idea communications between these Response: We understand that that AUC consultation creates new professionals. We also note that section primary care physicians will be barriers for Medicare beneficiaries, and 1834(q)(4) of the Act clearly specifies significantly impacted by the AUC believe that while technology itself that AUC consultation is required for program and have acknowledged this cannot improve care coordination or ordering professionals and does not throughout implementation of this patient outcomes, the use of that provide for instances where program. We are making every effort to technology can be a tool for consultation by furnishing professionals implement a program that does not practitioners to use in working toward is an acceptable alternative, even if only impart excess levels of burden but still improving care for Medicare for the purpose of avoiding claims includes all statutorily required beneficiaries. To this end, CDSMs can denials. We do not believe the statute provisions and is designed to achieve provide efficiencies in administrative affords us the authority to allow goals of the PAMA. processes which support clinical furnishing professionals to consult in Comment: Some commenters noted effectiveness, leveraging automated lieu of or in the absence of consultation that since AUC consultation information patient safety checks, supporting by ordering professionals. For all other will be required on the claim for the clinical decision making, enabling purposes, we remind commenters that imaging service ordered, only the wider access to health information for furnishing professionals are not furnishing professional, often including patients, and allowing for dynamic specifically prohibited from consulting the hospital where imaging services are communication between providers. We specified applicable AUC through a provided, will be held accountable if believe that as ordering professionals CDSM. AUC are not consulted. Because the continue to engage with qualified PLEs, Comment: Some commenters ordering professional is required to qualified CDSMs and CMS, AUC consult and their action, or inaction, requested clarification regarding the role consultations will complement the impacts payment for the furnishing of local coverage determinations (LCDs) practice of medicine. and national coverage determinations professional, commenters stated that we Comment: Some commenters (NCDs) under the AUC program. should find a way to hold the ordering questioned the overall approach we are Commenters requested that CMS professional accountable as well. taking in implementing this program. identify whether LCDs and NCDs take Response: The fourth component of Commenters noted that the program precedent over specified applicable the AUC program in section 1834(q)(5) should not be set in place until it is AUC, or if advanced diagnostic imaging of the Act includes the identification of determined that use of AUC actually orders that are considered appropriate outlier ordering professionals, which we improves utilization of diagnostic based on consultation with specified believe will distinguish and provide imaging. Other commenters reiterated applicable AUC would be covered consequences for those ordering their opposition to using the AUC under Medicare if such order was not professionals that fail to comply with covered by an LCD or NCD. Some AUC. Through facilitation of a prior consultation requirement to withhold commenters requested that AUC be the authorization requirement for such payment for rendered services. only criteria for medical necessity of identified professionals, as specified Response: Section 1834(q) of the Act advanced imaging services and other under section 1834(q)(6) of the Act, we as amended by section 218(b) of the commenters insisted that we instruct believe we will fulfill the shared goal of PAMA identifies specific requirements MACs to retire LCDs for advanced assisting both ordering and furnishing for the implementation of the Medicare imaging services once the AUC program professionals in making the most AUC program. The program must be is implemented. One commenter also appropriate treatment decisions for implemented and must include all recommended that we instruct qualified Medicare beneficiaries. Although we detailed components in the statute. We PLEs to adhere to NCD requirements did not propose to implement these believe the approach we are taking is when developing AUC. sections in the CY 2017 PFS proposed consistent with the requirements in the Response: At this time we consider rule, we continue to expect that PAMA. LCDs and NCDs to be active and binding consultations with physicians, Comment: Some comments focused policies detailing the criteria upon practitioners and other stakeholders will on requests for practitioner and patient which Medicare coverage or non- serve as part of the process to hold education efforts. Commenters coverage is based. For the purposes of accountable outlier ordering requested that we educate practitioners this program, consulting with AUC is professionals, and believe that such and allow for adequate time to do so. not a replacement for a determination of dialogues will yield meaningful results. Another commenter recommended that medical necessity. Consultation with We recognize that this response does we inform patients on the AUC program AUC that conflict with an LCD or NCD not address those ordering professionals and explain both the need for the does not modify the applicability of the that consistently fail to consult AUC at program and supposed benefits. This LCD or NCD. Specified applicable AUC all, and we will continue to discuss commenter also recommended that we do not override LCDs or NCDs. internally the extent to which such encourage other payers to use the same Comment: Some commenters stated professionals would be impacted by this criteria as the Medicare AUC program to that the disproportionate burden of the AUC program and other Medicare avoid additional administrative burden AUC program is on primary care programs. on providers. This commenter physicians. Many commenters noted in Comment: Some commenters recommended that we inform clinicians general the additional burden, both requested that we ensure that AUC of the expected cost associated with administratively and financially, the consultation requirements do not create compliance with the AUC program AUC program will create for providers. issues with patient access to care due to requirements.

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Response: We plan to develop and Initiatives-Patient-Assessment- D. Reports of Payments or Other provide educational materials about the Instruments/Appropriate-Use-Criteria- Transfers of Value to Covered AUC program before implementation of Program/index.html. Recipients: Summary of Public this program. We also expect many Comment: Many commenters Comments stakeholders will work to educate and communicated their appreciation of 1. Background inform providers and the public and efforts by CMS to actively engage with other interested parties about the In the February 8, 2013 Federal program. We do not have control over stakeholders to implement this program Register (78 FR 9458), we published the what other payers choose to implement as mandated by the section 218(b) of the ‘‘Transparency Reports and Reporting of and do not have cost projections PAMA amending section 1834(q) of the Physician Ownership or Investment associated with implementation of this Act. Other commenters asked how they Interests’’ final rule (Open Payments program at this time as they relate to can become involved and when CMS Final Rule) which implemented section regulations yet to be proposed through will reach out directly to them. 1128G of the Act, as added by section notice and comment rulemaking. Response: We have found the 6002 of the Affordable Care Act. Under Comment: One commenter noted that extensive interactions we have had with section 1128G(a)(1) of the Act, different terminology is used in the two a wide range of stakeholders over the manufacturers of covered drugs, devices, biologicals, and medical proposed rules with the CY 2017 OPPS past several years to be highly supplies (applicable manufacturers) are proposed rule using the term ‘‘imaging instrumental and essential to the supplier’’ and the CY 2017 PFS required to submit, on an annual basis, development of this program. Many proposed rule using ‘‘furnishing information about certain payments or stakeholders reached out to us from professional.’’ The commenter noted other transfers of value made to that the PAMA uses the term early on and we have reached out to physicians and teaching hospitals ‘‘furnishing professional’’ and asks that other organizations when issues (collectively called covered recipients) CMS use consistent terminology for the particularly relevant to their areas of during the course of the preceding parties furnishing the radiology service focus arise. We have also expanded our calendar year. Section 1128G(a)(2) of the and more clearly define the parties/ stakeholder interactions through Act requires applicable manufacturers entities that would fall into the standard numerous conferences and meetings and applicable group purchasing term. held by various organizations. organizations (GPOs) to disclose any Response: We understand Furthermore we receive regular email ownership or investment interests in commenters’ confusion. All components inquiries that create an open dialogue such entities held by physicians or their of the Medicare AUC program are being with more stakeholders and are always immediate family members, as well as implemented through the PFS. The use happy to interact with any individual or information on any payments or other of ‘‘imaging supplier’’ in the OPPS is organization with an interest in the AUC transfers of value provided to such not relevant to the AUC program. Under program. The best way to contact the physician owners or investors. The the AUC program and as specified in CMS AUC Team is through the AUC Open Payments program creates section 1834(q)(1) of the Act, the term program resource box: ImagingAUC@ transparency around the nature and ‘‘furnishing professional’’ is defined as cms.hhs.gov. We check the resource box extent of relationships that exist a physician (as defined in section between drug, device, biologicals and regularly and respond to all inquiries. 1861(r) of the Act) or a practitioner medical supply manufacturers, and described in section 1842(b)(18)(C) of These additional comments will assist physicians and teaching hospitals the Act who orders an applicable us in further building out the AUC (covered recipients and physician imaging service which we codified in program as we move into the next owner or investors). The implementing § 414.94(b) as discussed in the CY 2016 component for implementation in future regulations are at 42 CFR part 402, PFS final rule. rulemaking and have not resulted in any subpart A, and part 403, subpart I. Comment: Several commenters made changes to our proposals. We have In addition to the Open Payments various recommendations and discussed above, throughout the final rule, we issued final regulations in suggestions regarding the development preamble, our changes in response to the CY 2015 PFS final rule with of AUC, the type of AUC that should be public comment. We thank the public comment period (79 FR 67758) that used under this program and their for their comments and appreciate the revised the Open Payments regulations. involvement in identifying and/or detailed feedback and recommendations Specifically, we: (1) Deleted the developing AUC for use under this from stakeholders. We believe the definition of ‘‘covered device’’; (2) program. removed the continuous medical changes based on public comments have Response: We remind readers that education (CME) exclusion; (3) improved the identified priority clinical through the CY 2016 PFS final rule with expanded the marketed name reporting comment period, we established new areas and the qualified CDSM requirements to biologicals and medical § 414.94 and included requirements requirements and process for supplies; and (4) required stock, stock regarding the development of AUC and qualification. We are finalizing without options, and any other ownership who can be qualified to develop, modify change the proposals for the interests to be reported as distinct forms and endorse AUC. We will not be determination of non-adherence and the of payment. developing specified applicable AUC for exceptions under this program. We will Since the publication and consultation under this program. Rather continue to post information on our implementation of the Open Payments specified applicable AUC, that ordering Web site for this program accessible at Final Rule and the CY 2015 PFS, professionals will be required to www.cms.gov/Medicare/Quality- various stakeholders have provided consult, are those developed, modified Initiatives/Patient-Assessment- feedback to us regarding a variety of or endorsed by qualified PLEs. The first Instruments/Appropriate-Use-Criteria- aspects of the Open Payments program. list of qualified PLEs was released in Program. As a result, we have identified areas of June of 2016 and can be found on the the rule that might benefit from revision CMS AUC program Web site at https:// or subregulatory clarification. To www.cms.gov/Medicare/Quality- consider the views of all stakeholders,

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in the CY 2017 PFS proposed rule (81 implementing multiple submission The following summary describes the FR 46395 through 46396), we solicited windows. types of data collected in the BPT, public comments regarding policy and • Implementing flexible reporting which we described in greater detail in operational issues related to the Open requirements so that applicable the proposed rule at 81 FR 46397–99: Payments program. manufacturers and GPOs can properly • Base period experience data. Examples of subject matter areas for and easily represent changes resulting • Trend assumptions. which we solicited public comments from mergers, acquisitions, and other • Manual rates and credibility included: (1) Expansion of the nature of business dealings. assumptions. payment categories; (2) length of • Clarifying the definition of PODs • Projected allowed costs. continued reporting obligations; (3) and how Open Payments requirements • Effective value of a plan’s cost- length of time in which Open Payments apply to PODs. sharing. data remains relevant to users; (4) These comments, submitted by a • Projected administrative expenses mandatory registration for applicable variety of parties, broadly supported our and information related to the plan’s manufacturers and GPOs; (5) pre-vetting effort to engage the program’s gain/loss margin. of payment information with physicians stakeholders before revising or creating • Plan-specific bid and benchmark, and teaching hospitals prior to new reporting requirements. We based on projected enrollment and risk submission; (6) definition of a teaching appreciate the commenters’ views and scores. hospital; (7) new teaching hospital recommendations and we will consider • Beneficiary rebate and beneficiary reporting elements; (8) option for early the public comments received in the premium for the plan. or continuous data submission; (9) the future through possible rulemaking or • Rebate allocations to MA impact of mergers, acquisitions, and publication of subregulatory guidance. mandatory supplemental benefits and other business dealings on reporting; No Open Payments program changes are buy down of the Part D basic premium, (10) clarification on the definitions of being proposed or finalized within this the Part D supplemental premium, and/ ownership and investment interest final rule. or the Part B premium. terms; and (11) definition of, and • Actuarial pricing elements for any collection of data from, Physician E. Release of Part C Medicare Advantage optional supplemental benefit packages. Owned Distributors (PODs). Bid Pricing Data and Part C and Part D In addition to these categories of data In response to our solicitation, we Medical Loss Ratio (MLR) Data collected in the BPT, MAOs must received 136 timely comments, 95 of 1. Overview of Proposed Rule submit supporting documentation to which were deemed relevant to the substantiate the actuarial basis of solicitation in that they suggested In the CY 2017 PFS proposed rule (81 pricing and an actuarial certification of matters to consider in future rulemaking FR 46162) we proposed to release the bid. and system enhancements. The majority certain data related to the bids We described the proposed regulatory of the comments focused on: submitted annually by Medicare • changes to allow for the release of MA Expanding or clarifying the nature Advantage Organizations (MAOs) and bid pricing data, along with the manner of payment categories enumerated in certain Medical Loss Ratio (MLR) data in which we proposed to make the § 403.904(e)(2). submitted annually by MAOs and Part release. We proposed to codify the • Changing the continued reporting D plan sponsors. In general, we requirements for release of MA bid obligation to a specific period of time, proposed to release the data submitted pricing data by adding new § 422.272 to such as 5 years after the payment or by MAOs in the Medicare Advantage subpart F of part 422. We proposed to transfer of value was made. (MA) Bid Pricing Tool (BPT), subject to • Publishing or refreshing the Open release to the public each year, after the a 5-year delay; and to release data first Monday in October, MA bid pricing Payments data so that it is accessible to submitted by MAOs and Part D sponsors stakeholders for an appropriate period data for MA plan bids that we accepted in accordance with MLR requirements, or approved for a contract year at least of time, such as 5 years or the number subject to an 18-month delay. In both of years in which an applicable 5 years prior to the upcoming calendar cases, the proposed release is subject to year, subject to specific exclusions manufacturer or GPO is required to specified exclusions. report. described in proposed § 422.272(c). We • Streamlining the Open Payments 2. Release of Bid Pricing Data proposed to amend the regulation text at § 422.504 by adding a new paragraph registration process and maintaining a. Summary of Proposed Rule voluntary registration for those (n)(2), which would require that an applicable manufacturers or GPOs that The proposed rule included a MAO acknowledge the release of MA do not report. discussion of both the statutory and bid pricing data as provided in • Requiring applicable manufacturers regulatory authority for collecting bids, § 422.272 as a mandatory contract and GPOs to pre-vet financial as well as an overview of how the provision; we also proposed certain information with physicians and information is collected. Each year, technical changes to § 422.504(n). The teaching hospitals before it is reported MAOs submit bids to CMS for proposed rule did not discuss these to Open Payments. participation in the Medicare Advantage changes to § 422.504(n) in detail as part • Clarifying the regulatory definition program. Information from these bids is of the proposal to release MA bid data, of a teaching hospital. primarily collected through the MA but they were reflected in the proposed • Adding non-public data elements BPT, which was developed by CMS. regulation text at 81 FR 46471. that allow additional detail about the The data collected in the BPT Specifically, we proposed to move the specific recipient or department of a demonstrates the actuarial bases of the existing provisions regarding the release teaching hospital that received a plan bid. Each MA plan bid is an of summary CMS payment data at payment or transfer of value. estimate of the plan’s revenue existing paragraph (n) to paragraph • Expanding the timeframe in which requirement to cover plan benefits for a (n)(1) and to redesignate the existing the Open Payments program can accept projected population, including benefit paragraphs (n)(1)(i) through (iv) and data submissions from applicable costs net of cost-sharing, non-benefit (n)(2) as (n)(1)(i)(A) through (D) and manufacturers and GPOs, such as by expenses, and gain/loss margin. (n)(1)(ii), respectively.

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We also described the data that would its redaction from public availability sharing, and utilization information be subject to exclusion from release. We and suggestions for what safeguards collected in the MA BPT could be used proposed not to include any Part D bid might be implemented to appropriately by a competitor to derive not only future pricing data, or any information protect those portions of the data. We bid amounts in the aggregate, but also to pertaining to the Part D prescription noted that detailed explanations should derive components of future bids for drug bid amount for an MA plan contain specific examples which show specific benefits contained in the bid. offering Part D benefits. We also how this information disclosure could Some commenters remarked that this proposed to exclude any narrative cause substantial competitive harm to could incent the gaming of bids, cause information included in the MA BPT, MAOs. Specific examples should have MAOs to exit markets, and create MSA BPT, and ESRD–SNP BPT (1) cited the particular information disincentives for new market entrants. regarding base period factors, manual proposed to be released and explained Response: We share the commenters’ rates, cost-sharing methodology, how that information differs from interest in the continued success of the optional supplemental benefits, or other publicly available data; (2) pointed to MA program. In recent years, topics for which narratives are required the particular entity or entity type that enrollment has grown while plan by us under § 422.254. We proposed to could gain an unfair competitive quality has demonstrated continued exclude supporting documentation that advantage from the information release; improvement. Our goal is to continue to is provided outside of the BPT template. and (3) fully explained the mechanism make the MA program a strong and We proposed to exclude any by which the release of that particular healthy one. information identifying Medicare information would create an unfair As discussed in the proposed rule, we beneficiaries or other individuals. competitive advantage for that believe this disclosure is consistent with Regarding other individuals, we particular entity. Similarly, we were Presidential directives to make explained that our proposal would interested in comments that our information available to the public, and exclude the names and contact proposed scope for release was too with our goals of allowing public information of certifying actuaries and narrow and unnecessarily protects data evaluation of the MA program, MAO contacts from the releases. that is not confidential and should not encouraging research into better ways to Finally, we proposed to exclude any bid be protected. provide health care, and reporting to the review correspondence between us or We also solicited comments on the public regarding federal expenditures our contractors and the MAO. proposed 5-year delay and its effect and other statistics involving this We detailed the rationale for the with respect to any competitive program. Analysis of this data could proposed releases. We discussed how disadvantages to MAOs that could result inform future bidding and payment the release of this data is in support of from the disclosure of MA bid pricing policies. Further, releasing MA bid the Administration’s commitment to data. We solicited comments on pricing data, particularly in conjunction transparency. We indicated that release whether a shorter period would suffice with information already released under of MA bid pricing data could support to protect MAOs from competitive harm § 422.504(n), will provide insight into public research into the MA program associated with the disclosure of the use of public funds for the MA that could support the agency’s goals for confidential commercial information or program, providing appropriate the program, including the delivery of if a longer period is necessary to transparency about the administration better healthcare. We also suggested the adequately protect the information. of the program. data release would promote public We discussed the need to balance accountability of the program. b. Comments these goals with the need to protect the We also addressed past and ongoing We received 30 comments from the proprietary information of the MAOs attempts to achieve release of this data public, some in support and some in that submit this bid pricing information under the Freedom of Information Act, opposition to our proposed release of to us. Our proposed time lag of 5 years 5 U.S.C. 552 (FOIA). We have received MA bid pricing data. We reviewed these prior to the upcoming calendar year was several requests under the FOIA for the comments closely, and we appreciate an important element in our decision to type of MA bid pricing data we the concerns identified in comments on release the MA bid pricing data. proposed to release. Under the FOIA, our proposed release. These comments As part of our efforts to balance our we are required to make available any are addressed below. mission to effectively administer federal data released under the FOIA that the Comment: About half of the health care programs and increase data agency determines are likely to become commenters expressed support for the transparency with MAOs’ proprietary the subject of subsequent requests, or proposal to release MA bid pricing data. interests, we requested that commenters that have been requested by three or Response: We appreciate the support. who oppose release of MA bid pricing more requesters. As a result of one such Comment: A number of commenters data provide a ‘‘detailed explanation of FOIA request, we have already released stated that the release of MA bid pricing good cause’’ for the redaction of some or publicly a limited set of MA bid pricing data would result in substantial all MA bid data from public release. As data. This data, from 2011, is available competitive harm to MAOs and to the noted in section III.E.2.a of this final at https://www.cms.gov/Medicare/ MA program. Commenters expressed rule (‘‘Summary of Proposed Rule’’), we Health-Plans/ concern that release of plan-level stated that detailed explanations should MedicareAdvtgSpecRateStats/ financial data, even with the 5-year contain specific examples which show DataRequests.html. This data was delay, would provide current and future how this information disclosure could posted in June 2013. competitors with sensitive information cause substantial competitive harm to We solicited comments on the scope such as gain/(loss) margin and the MAOs. Specific examples should have of the proposed release of MA BPT profitability of serving beneficiary (1) cited the particular information worksheets and data elements. We were populations in specific markets, which proposed to be released and explained particularly interested in comments on could expose business strategies, reduce how that information differs from whether the MA bid pricing data we innovation, and undermine the publicly available data; (2) pointed to proposed to release contains proprietary functioning of a competitive the particular entity or entity type that information, and if so, we requested marketplace. These commenters stated could gain an unfair competitive detailed explanations of good cause for that the detailed claims cost, cost advantage from the information release;

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and (3) fully explained the mechanism goals that we believe will be served by commenters stated that with knowledge by which the release of that particular publicly releasing MA bid pricing data, of MA bid pricing data, lower-priced information would create an unfair discussed above, we are finalizing our providers would negotiate for known competitive advantage for that proposal to release MA bid pricing data higher rates, and that providers may be particular entity (81 FR 46402). after a 5-year delay, subject to certain less likely to agree to lower-cost We believe that commenters did not specified exclusions. arrangements if the details will be provide data analysis that met this Comment: A few commenters shared with their competitors, which requested standard of specificity to help expressed skepticism that the release of leads to higher unit prices for healthcare us determine that release of the data as MA bid pricing data will cause services across the MA program and proposed would cause unfair competitive harm to MAOs, and stated thus higher total costs. competitive harm or negative that there is no real competition among Several commenters also described, at consequences for the MA program. We MAOs for government approval of bids a general level, various methods for did not receive specific examples that because we approve multiple reasonable reverse engineering provider payment illustrated how the structure of a bids. Another commenter stated that if rates using certain information that particular healthcare market (for MA bid pricing data is publicly MAOs submit in their bids. A few example, a particular county or multi- released, there cannot be competitive commenters stated that the release of an county healthcare market), combined harm or unfair commercial gain because MA plan’s average historical cost per with universal access to certain 5-year- each MAO would have the same unit could be used to calculate old data elements in the MA BPT, could information about its competitors and negotiated rates by service category and create an unfair competitive advantage. would be equally capable of using that market, particularly where health care A number of commenters expressed information. The commenter stated that markets are highly concentrated. concern about the use of MA bid pricing such symmetrical access to data Response: A negotiated rate between data to reverse-engineer provider obviates the potential for any unfair an MAO and a provider (facility, payment rates, stating that this could commercial gain for one MAO over physician, or other provider) refers to cause competitive harm, especially in another, and that only asymmetric the payment rate that an MAO has highly consolidated markets in which disclosure can be a condition for established by contract with a provider. there are a limited number of providers substantial competitive harm. Typically negotiated rates are specified for a specific service. A few commenters Response: We do not agree entirely at a unit of payment such as per person stated that a provider might determine with the comments stating that the per month, per diem rate, per service whether its payment rates were higher public release of MA bid pricing data rate, or a global capitation rate (for or lower than the average in such a cannot cause competitive harm or unfair example, a physician is paid a consolidated market (especially for MA commercial gain. We note that the negotiated rate for managing all services bids for single-county MA plans) by public release of MA bid pricing data received by a beneficiary under a comparing its negotiated rate to the could give new market entrants specific health plan). average unit price reported in the BPT, information on competitors’ MA plan We do not have access to these in order to increase its leverage in future bids while such information about their negotiated rates between an MAO and negotiations with the MAO. own bid(s) would not have been its contracted network of providers, so We understand this concern and released, allowing them to potentially we cannot determine how closely an appreciate the sensitivity of the benefit from asymmetric disclosure. entry in the BPT may represent negotiations between private health However, we believe that our proposed negotiated rates in provider contracts. plans and healthcare providers. We time lag of 5 years prior to the upcoming Since payment figures in the MA BPTs discuss these comments a greater length calendar year is an important element in are grouped into general service below. However, as discussed in more mitigating competitive harm to MAOs or categories (such as ‘‘Inpatient Facility’’ detail throughout this final rule, we the potential for unfair commercial gain and ‘‘Skilled Nursing Facility’’) and believe that the 5-year delay in the for new market entrants when releasing represent average costs across multiple release of MA bid pricing data would MA bid pricing data. providers, beneficiaries, services, and make any information about payment Comment: Many commenters stated sites of service, we believe that the BPT rates that could be obtained from an that MA bid pricing data could be used information is unlikely to give more examination of plan bids stale and no to calculate an MA plan’s negotiated than high-level insight into contractual longer commercially sensitive. provider payment rates. Several negotiated rates. Finally, in 2013, we released certain commenters cited a Federal Trade Even if reverse engineering of 2009 actual costs (worksheet 1) from the Commission (FTC) letter (at https:// provider rates were possible, the 5-year 2011 MA bid pricing data, as required www.ftc.gov/system/files/documents/ delay renders that information even less by the U.S. District Court for the District advocacy_documents/ftc-staff- competitively useful or relevant. We do of Columbia in Biles v. Dep’t of Health comment-regarding-amendments- not believe that any commenters and Human Services, 931 F. Supp. 2d minnesota-government-data-practices- established that a provider who uses 211 (D.D.C. 2013). (Discussion of this act-regarding-health-care/ MA bid data to estimate the negotiated case is at 81 FR 46403 of the proposed 150702minnhealthcare.pdf) stating that rate that a competitor was receiving 5 rule.) Given that this information has the public disclosure of competitively years earlier would be greatly been released to the public, and we have sensitive pricing information may be advantaged by this information. not been made aware of any instances used in an anticompetitive manner that Delivery of health care is constantly of competitive harm, we do not see any increases costs and adversely impacts evolving and MAOs are continually reason why the release of 5-year-old consumers. The commenters stated that seeking ways to gain efficiency in data could cause competitive harm. when a provider knows that another providing care. For example, the In the absence of any evidence or provider is receiving a higher payment number of providers, the cost of analysis demonstrating that competitive rate for a service, the provider will services, and utilization patterns harm would result from the proposed demand at least the same rate as the associated with an MAO are very likely release of MA bid pricing data, and in higher-paid provider, thereby raising the to change over a 5-year period; we consideration of the important policy ‘‘price floor’’ for the service. Some believe that these changes—particularly

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as the health care industry moves 5 years (that is, bids should not have documents support the final accepted toward alternative payment negative margins for more than 4 version of the bid. We proposed, and methodologies—mitigate any risk consecutive years). Absent the 5-year finalize here, that these documents will associated with reverse engineering of delay, we were concerned that the not be included in the data that we historical payment rates. As such, we public might be able to use this margin release under this rule. remain unconvinced that releasing this rule to deduce competitively sensitive We agree that more recent MA bid information has potential to cause harm information from a plan’s bids. data is more competitively sensitive to the marketplace as a whole or to the We also believe that 5 years is than bid data that is at least 5 years old, competitive position of MAOs. sufficient time for competitively and we recognize that, even if the Comment: Some commenters stated sensitive bid data to become no longer release of bid pricing data for a single, that our proposal to release multiple competitively sensitive. The time lag more recent year would not itself create years of data initially, followed by the represents a buffer between the a risk of substantial competitive harm, release of more recent bid data on an development and implementation of there could be an increased likelihood annual basis, would make it possible for pricing strategies that can be distilled of substantial competitive harm providers and competitors to analyze from multiple years of data and the resulting from the release of a more cost trends, which could inform observed relationship and trend from 1 recent year’s bid pricing data when that negotiations and adversely impact year to the next, and we believe that this data can be analyzed in combination competition by providing insight into buffer mitigates any competitive with publicly-released bid data for profit objectives and growth strategies. disadvantage that might otherwise result previous years and trended forward to One commenter noted that the Biles from the disclosure of multiple years of predict current or future bids. court indicated that its conclusion (that bid data. As an example, we noted that If a FOIA request is received, we will the MA bid pricing data requested by an MAO looking to enter a new market follow our ordinary FOIA procedures the plaintiff could be released without is significantly less likely to gain an and not release data the agency impacting market conditions) was unfair commercial advantage from being determines are trade secrets, or specific to the request for a single year’s able to examine and trend 5-year-old bid commercial or financial information data, and that a request for second year’s pricing data than if the MAO were able protected by Exemption 4 to the FOIA data that could be trended creates a to examine and trend more recent bid (5 U.S.C. 552(b)(4)). We also note that distinguishable factual situation that pricing data (81 FR 46400). we do not view data releases made requires a new and separate analysis. We continue to believe that the under the authority of the new § 422.272 931 F.Supp.2d at 227 n.22. The proposed exclusion of MA BPT as FOIA releases. These releases are commenter stated that, if the proposal to narrative fields and supporting discretionary disclosures of data to the release bid data after a 5-year delay is documentation is appropriate because public, rather than in response to a finalized, we should deny FOIA MAOs provide information in narrative request under the FOIA. Section requests for more recent data, both fields and supporting documentation 422.272 permits the release of data, but because this data is precluded under that is commercially sensitive does not require it. As noted in the Exemption 4 as ‘‘trade secrets and information in a way that the cost and proposed rule (81 FR 46396–97), we commercial or financial information enrollment estimates in the BPT are not. believe that these releases are consistent obtained from a person [that is] MA BPT narrative fields and supporting with the principles of transparency in privileged or confidential,’’ and because documentation can include sensitive government that underlie the FOIA and this data could be analyzed in information such as multi-year regional that regular release of this data might combination with the bid data that we or national-level information on an mitigate the number of FOIA requests are proposing to release after a 5-year MAO’s approach to cost-sharing and the associated need for repeated delay to potentially reveal competitively methodology or projection factors, analyses of this data. sensitive trend information. Finally, one which can provide insight into longer- Comment: A number of commenters commenter stated that we did not term strategies, or they may include suggested that bid pricing data is explain the rationale for our assumption information on provider contracting, inherently proprietary, and therefore, that the MA bid data is no longer such as fee schedules or summaries of should not be released. A few commercially sensitive after 5 years. provider contract terms. Provider commenters stated that pricing data is Response: We appreciate the contract terms and actual fee schedules, confidential, proprietary information commenters’ concerns about how bid for example, would be more covered by Exemption 4 of the FOIA. data for multiple years can both reveal competitively sensitive than the Response: We disagree with the actual trends in the past and can be estimated provider payment rates that commenters. Absent detailed analytical trended into the future to predict an could be generated from 5-year-old bid evidence, which we solicited in the MAO’s projected gains and losses, figures at the broad service level rulemaking process but did not receive, which could give competitive insight categories in the MA BPT. In addition, as discussed above, we do not believe into business strategies. However, as we we believe that supporting the release of bid pricing data on a 5- stated in the proposed rule at 81 FR documentation could cause year lag poses a threat of competitive 46400, we believe that our proposed 5- misinterpretation of the MA bid pricing harm. year delay renders multi-year data that we proposed to release. We Specifically, regarding the comment comparisons of pricing trends less proposed to release only the MA bid that MA bid pricing data is proprietary relevant to the current year of MA plan pricing data for MA plan bids that were and covered by Exemption 4 of the pricing. accepted or approved by CMS. FOIA, we restate here that we are We selected a 5-year delay, in part, However, MAOs often upload multiple finalizing our proposal to expand the due to the requirements associated with versions of each plan bid in response to basis and scope of our regulations on projected margins in the bids submitted our requests for further information or MA bidding to incorporate section by MAOs, particularly when the margin corrections. Given the volume of 1106(a) of the Act (42 U.S.C. 1306(a)), is projected to be negative. MAOs with supporting documentation submitted by which authorizes disclosure of negative margins in their bids are MAOs, it may be difficult for a member information filed with this agency in expected to achieve profitability within of the public to identify clearly which accordance with regulations adopted by

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the agency. A substantive regulation competitive use of the MA bid pricing allow the public to better understand issued following rulemaking provides data, the data should be released only how public dollars are spent in the MA the legal authorization for government through the ResDAC portal for program. Beneficiaries may or may not officials to disclose commercial researchers as Research Identifiable seek to use this data to make plan information that would otherwise be Files (RIFs). Another commenter urged choices and we did not identify that as required to be kept confidential in us to aggregate the MA bid pricing data a specific reason for the release of MA accordance with 18 U.S.C. 1905. See and release it through our established bid pricing data. Chrysler Corp. v. Brown, 441 U.S. 281, methodology of public data release, the Comment: Some commenters stated 306–08 (1979). We note as well that Public Use File (PUF), which generally that the release of the MA bid pricing under 45 CFR 401.105(a), we have can be understood by technical data would likely result in an increase adopted a regulation that permits audiences after a review of supporting in the cost of MA plan basic benefits publication and release of data that documentation. and supplemental services (for example, would not be exempt from disclosure Response: We appreciate the dental benefits) as MAOs respond to a under the FOIA or prohibited from recommendation that the bid pricing new competitive situation. Commenters disclosure under other law, even if a data be released through ResDAC. CMS’ stated that this would harm request has not been submitted. Research Data Assistance Center beneficiaries because it will cause MA Comment: Many commenters offered (ResDAC at www.resdac.org) is a critical plans to offer fewer supplemental alternative ideas for what MA bid part of the Administration’s benefits, increase cost-sharing, or both. pricing data to release. These commitment to transparency, and has Response: We expect that the MA commenters stated that the data should been a valuable resource for researchers program will continue providing be aggregated above the level of the MA (in releasing RIFs) and the public (in affordable and comprehensive health plan bid, such as at the contract level releasing PUFs). However, we do not plan options to Medicare beneficiaries. because it would be more difficult to agree that this release should be through We did not receive any detailed analysis reverse-engineer provider payment rates the ResDAC resource or require the to demonstrate that releasing 5-year-old and other proprietary information. signing of a Data Use Agreement (DUA) MA bid pricing data is likely to have the Another commenter suggested releasing that restricts use and disclosure of the harmful impact on beneficiaries raised only an aggregate financial measure that data (which is required for use of RIFs). by the commenters. reflects the sum of non-benefit expenses Because commenters did not identify a Comment: Commenters expressed and gain/(loss) margin. Some specific competitive harm associated support for our proposal to not release commenters recommended additional with the public release of the bid data, Part D bid pricing data. Two data exclusions, for example, that all we will publish it without restriction on commenters argued against the release plan-level financial data should be the CMS Web site (www.cms.gov), of Part D bid pricing or manufacturer’s excluded because it would provide subject to the exclusions as finalized in rebate data, and one commenter stated current and potential future competitors this rule. that the release of Part D bid pricing or with proprietary, competitively Comment: Several commenters stated rebate data would violate the Takings sensitive information such as that bid pricing data should not be Clause of the U.S. Constitution, as well profitability of specific beneficiary released because such data is not useful as the Part D noninterference clause populations. One commenter stated that to beneficiaries, and it has a high risk of (section 1860D–11(i) of the Act). One information used to project an MA being misinterpreted. One commenter commenter expressed concern that our plan’s revenues and costs, such as stated that beneficiaries will likely find broad interpretation of our authority to enrollment and population projections, bid data confusing and less informative release MA bid data through notice-and- should not be released at granular levels than our Star Ratings, which are comment rulemaking could cause us to (for example, county-level details). considered a more accessible and ignore legal barriers to the release of Commenters stated their concern that straightforward measure by which to Part D pricing data. the 5-year timeline we proposed for compare plan value and quality. One Response: We appreciate the support. releasing the MA bid data is too short, commenter stated that we should refrain Since we proposed to exclude Part D bid and one commenter stated that bid data from releasing bid data to the public data from our proposed release of MA should be released only after 10 years ‘‘until there is a proven case that the bid pricing data and are finalizing those and that any release after that time release would lead to improvements in exclusions in this final rule, we exclude all plan-identifying the quality of care overall in the consider the comments arguing against information. Medicare program.’’ the release of Part D bid pricing and Response: We appreciate the concerns Response: We appreciate the concerns rebate data to be beyond the scope of the raised by the commenters. However, that were raised regarding the proposed rule. To the extent that these based on our analysis of the comments possibility that the bid data we comments support the exclusion in our we received, we did not find that any proposed to release could be rule, we appreciate the support. commenter provided sufficiently misinterpreted. We intend to release Comment: Several commenters detailed evidence of competitive harm with each year’s bid data the BPT expressed support for the proposed associated with the release of any of the instructions and data dictionary for that release of MA bid pricing data, but fields proposed for release after the year to minimize confusion and the stated that the 5-year lag in release was proposed 5-year delay. As such, we do possibility of misinterpretation of the too long for timely analysis that would not consider these exclusions or any data. Further, as noted in the proposed still be beneficial to informing future further aggregation of bid data to be rule at 81 FR 49396, we anticipate that policymaking and reforms. Some necessary. researchers, as well as other members of commenters stated that MA Comment: Several commenters the public will have use for this organizations are paid with public funds recommended that the MA bid pricing information and that research based on to provide a public benefit, and data not be released to the public on the the data may provide important insights transparency should outweigh the CMS Web site, but be made available for future MA policy development and concern of competitive harm, in part through other mechanisms. One for developing health care policy. because there is limited competition in commenter suggested that, to avoid any Disclosing MA bid pricing data will the program in that we approve multiple

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reasonable bids, not merely the lowest appropriate way; the commenter data, and will support public research bidders. Some commenters also stated supported our proposed exclusion of that can potentially strengthen the that significant changes in the health narrative information from the proposed program. care landscape can occur over the release of MA bid pricing data but While we are not modifying any of the course of 5 years, and bid pricing data argued that researchers would find it proposed exclusions, we note that we that is 5 years old will constrain extremely challenging if not impossible will withhold certain fields within the researchers’ ability to do meaningful to fully understand a plan’s bid without BPT where necessary to comply with policy analysis. Finally, one commenter this excluded information. Finally, one our current cell size suppression policy. suggested a 3-year lag instead of a 5-year commenter noted that we have made This policy stipulates that no cell (for lag in release of MA bid pricing data. available on our Web site MA bid data example, admissions, discharges, Response: We appreciate the that was requested under the FOIA, and patients, services, etc.) 10 or less may be comments, and the interest in having asked whether this data had proven displayed. For example, a plan with access to more recent data. Through useful to researchers. more than 11 enrollees may have fewer notice and comment rulemaking, we Response: As stated in the proposed than 11 beneficiaries who receive have sought to balance an interest in rule, we believe that facilitating public benefits that fall under one of the BPT’s transparency with the need to protect research using MA bid pricing data service categories. The policy is proprietary information. We received could lead to better understanding of designed and implemented in order to comments on both sides of this issue, the costs and utilization trends in MA protect against disclosure of and have reviewed these comments and support future policymaking for the individually identifiable data as our critically. In this case, we believe it is MA program. We do not believe that it analysis has indicated the potential to important to maintain the 5-year delay is possible for one researcher or one set identify individuals where the we originally proposed. As discussed of researchers to address all policy information in the cell is based on 10 or above, data more recent than 5 years old questions regarding the MA program. fewer individuals. We interpret the may impose substantial competitive We expect that a wide range of research regulation text in this final rule (that harm on market participants, such as by studies could complement the work protects against and excludes from these providing an unfair competitive published by MedPAC. We believe that disclosures ‘‘information that could be advantage to new market entrants, who MA bid data could be useful to used to identify Medicare beneficiaries could use more recent data to determine researchers even without access to the or other individuals’’) to support this current pricing arrangements between narrative fields or supporting suppression policy. Further, to the existing plans and providers and documentation, and we have not extent that the suppression policy is undermine their negotiation strategies. received any comments that revised in the future for these purposes Such information would not be demonstrate convincingly or with to apply to cell sizes based on more than similarly available about new market specific examples to change our 10 individuals, we will apply that entrants to existing plans. position. Comment: One commenter stated that, Finally, regarding the usefulness of updated policy under this rule. In order if we release MA bid data without currently available MA bid pricing data for our release of MA bid pricing data including MAO names or plan IDs, it is to researchers, one commenter pointed to be consistent with our cell size likely that some plan sponsors with to research conducted by Dr. Brian Biles suppression policy, we may determine unique internal cost structures will be on behalf of the Commonwealth Fund, that certain fields in the BPT should be publicly identifiable while other and his work to examine costs in MA. withheld or redacted. competitors may not be identifiable, We believe that the data may be c. Summary of Proposed Technical giving certain plan sponsors serious accessed again in the future for further Change and Response to Public competitive advantage over others. research. Comments Response: All MA plan sponsors will After consideration of the public be identifiable in the bid data that we comments received, we are choosing to We proposed to amend § 422.250 on will release through the field labeled finalize the proposed MA bid pricing the basis and scope of the MA program ‘‘Organization Name.’’ While there are data release, codified at § 422.272, and to add a reference to section 1106 of the some organization names in MA bids the proposed contractual Act. As discussed in the proposed rule that differ from the name of the parent acknowledgment of the release, codified (81 FR 46396), section 1106(a) of the Act organization, a link can be established at § 422.504(n)(2), without modification. (42 U.S.C. 1306(a)) addresses through an internet search if a member We also finalize our proposal to amend requirements, including rulemaking, for of the public is interested in making that § 422.504 by moving the existing the agency to release information filed connection. provisions regarding the release of with it by outside parties. Comment: Several commenters summary CMS payment data at existing We received a few comments on the expressed skepticism about the paragraph (n) to paragraph (n)(1) and proposed technical change, summarized necessity of using bid data for health redesignating existing paragraphs below with our response. policy research. One commenter stated (n)(1)(i) through (iv) and (n)(2) as Comment: A few commenters that the proposed bid data release is (n)(1)(i)(A) through (D) and (n)(1)(ii), expressed concern that we proposed unnecessary for purposes of ensuring respectively. We appreciate the releasing MA bid pricing data in the CY program oversight or development of concerns raised by some commenters, 2017 PFS proposed rule, rather than health policy; the commenter noted that and we believe that these concerns are through a Part C and D rulemaking MA bids are already subject to our addressed by our decision to delay our process. The commenters stated that review and approval and a bid audit release of MA bid data by 5 years and this approach increased the likelihood process, and MedPAC analyzes bid data to exclude certain information from that many stakeholders would have and issues an annual report describing release, as discussed above. We been unaware of our proposal in time to program-wide trends. Another continue to believe that the release of provide detailed analysis of the impacts commenter expressed skepticism about MA bid pricing data is consistent with of the proposed data releases, and one the ability of researchers to use the data the Administration’s directives commenter suggested reissuing this we proposed to release in an effective, regarding the transparency of program proposal in a Parts C and D rulemaking.

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Response: The Administrative for failure to meet the 85 percent at § 422.2490(c) and § 423.2490(c) to Procedure Act (APA) and section 1871 minimum MLR requirement, including release the Part C MLR data and Part D of the Act generally require that rules be remittance of funds to CMS, a MLR data, respectively, for each published in the Federal Register in prohibition on enrolling new members, contract for each contract year, no proposed form, with a basis and and ultimately contract termination. earlier than 18 months after the end of purpose statement explaining the Under the regulations at § 422.2410 the applicable contract year. proposal, and then published in the and § 422.2460, with respect to MAOs, We proposed to amend the regulation Federal Register in final form, with and § 423.2410 and § 423.2460, with text at § 422.504 by adding a new revisions based on comments received, respect to Part D sponsors, for each paragraph (n)(2), which would require and responses to such comments. There contract year, each MAO and Part D that an MAO acknowledge the release of is no requirement governing how sponsor is required to submit a report to Part C MLR data as provided in proposed or final rules are packaged or us, in a timeframe and manner that we § 422.2490 as a mandatory contract organized, as long as the public is given specify, which includes the data needed provision. We also proposed to amend proper notice. The proposed rule (81 FR to calculate and verify the MLR and the regulation text at § 423.505(o) by 46162) clearly listed all Parts of the remittance amount, if any, for each adding a new paragraph (o)(2), which Medicare regulations that would be contract. For each contract year would require that a Part D sponsor affected by the proposed regulations beginning in 2014 or later, MAOs and acknowledge the release of Part D MLR (including part 422) and its title Part D sponsors are required to enter data as provided in § 423.2490 as a included a reference to release of their MLR data and upload their MLR mandatory contract provision. We Medicare Advantage data (‘‘. . . Reports to our Health Plan Management proposed certain technical changes to Medicare Advantage Pricing Data System (HPMS). The MLR Report is on § 422.504(n) and to § 423.505(o). The Release; Medicare Advantage and Part D our Web site at https://www.cms.gov/ proposed rule did not discuss these Medical Low [sic] Ratio Data Release Medicare/Medicare-Advantage/Plan- changes to § 422.504(n) and § 423.505(o) . . .’’), so there was adequate notice to Payment/medicallossratio.html, in detail as part of the proposal to the public of the content of the accompanied by instructions on how to release Part C and Part D MLR data, but proposed rule. That fully satisfies the populate the Report. they were reflected in the proposed requirements of the APA and section In the proposed rule, we summarized regulation text at 81 FR 46471–72. Our 1871 of the Act. the information collected in conjunction proposed technical changes to The presence of this rider was clearly with the MLR requirement. We § 422.504(n) are described in section discussed in the title of the proposed described the categories of information, III.E.2.a of this final rule (‘‘Summary of rule, and was also discussed in the Fact including: Proposed Rule’’). With respect to Sheet we released to the public at the • Revenue. § 423.505(o), we proposed to move the time of the rule’s display. We received • Claims. existing provisions regarding the release many comments from across the • Federal and State Taxes and of summary CMS payment data at industry, including a number of Licensing or Regulatory Fees. existing paragraph (o) to paragraph comments from MAOs and their trade • Health Care Quality Improvement (o)(1) and to redesignate the existing associations. This further demonstrates Expenses. paragraphs (o)(1) through (5) as (o)(1)(i) that adequate notice was provided. • Non-claims Costs. through (v). We also explained the rationale for After consideration of the public • Member Months. the proposed data release. As with our comments we received on the proposed We also described the process used to release of MA bid pricing data, technical amendment, we are finalizing calculate the MLR with this discussed in section III.E.2.b of this final the amendment as proposed. information, including the numerator rule (‘‘Comments’’), our release of Part 3. Release of MLR Data and denominator. C and Part D MLR data is consistent We explained the proposed regulatory a. Summary of Proposed Rule with Administration initiatives to changes to provide for the release of Part improve federal management of The proposed rule provided C and Part D MLR data, along with the information resources by increasing data background on the Part C and Part D manner in which we proposed to make transparency and access to federal Medical Loss Ratio requirements, the release. We proposed to codify the datasets. We also noted in the proposed including the statutory and regulatory new requirements for the release of Part rule that we already publicly release authority. An MLR is expressed as a C and Part D MLR data by adding new MLR data that issuers of commercial percentage, generally representing the regulations at § 422.504 (related to health plans submit each year as percentage of revenue used for patient contract terms) and § 422.2490 (related required by section 2718 of the Public care rather than for such other items as to the details of the MLR data release) Health Service Act. This data is listed administrative expenses or profit. In the of part 422, with respect to Part C MLR publicly at https://www.cms.gov/CCIIO/ May 23, 2013 final rule (78 FR 31284), data, and § 423.505 (related to contract Resources/Data-Resources/mlr.html. In we codified the MLR requirements for terms) and § 423.2490 (related to the releasing Part C and Part D MLR data, MAOs and Part D sponsors in the details of the MLR data release) of part we are seeking to align with the regulations at 42 CFR part 422, subpart 423, with respect to Part D MLR data. disclosure of commercial MLR data. X, and part 423, subpart X, respectively. We proposed to define Part C MLR data Finally, we discussed our belief that For contracts beginning in 2014 or at § 422.2490(a), and Part D MLR data at Part C and Part D MLR data could be a later, MAOs and Part D sponsors are § 423.2490(a), as the data the MAOs and valuable tool for consumers, required to report their MLRs and are Part D sponsors submit to us in their researchers, and the public. We believe subject to financial and other penalties annual MLR Reports, as required under that the release of this data will for failure to meet the statutory existing § 422.2460 and § 423.2460. At facilitate public evaluation of the MA requirement that they have an MLR of § 422.2490(b) and § 423.2490(b), we and Part D programs by providing at least 85 percent (see § 422.2410 and proposed certain exclusions to the insight into the efficiency of health § 423.2410). Section 1857(e)(4) of the definitions of Part C MLR data and Part insurers’ operations. In addition, we Act requires several levels of sanctions D MLR data, respectively. We proposed believe that the release of certain MLR

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data will provide beneficiaries with Part D sponsors are required to describe giving the public access to data that can information that can be used to assess the methods they used to allocate be used to evaluate the efficiency of the relative value of Medicare health expenses, including incurred claims, MAOs and Part D sponsors and and drug plans. We acknowledged in quality improvement expenses, federal providing enrollees with information the proposed rule that the commercial and state taxes and licensing or that can be used to compare the relative MLR varies from the Part C and Part D regulatory fees, and other non-claims value of health plans. For example, our MLR in certain ways. For example, costs. A detailed description of each proposed release excludes MAOs’ and commercial MLR data is collected from expense element is provided, including Part D sponsors’ responses to questions issuers at the state level, aggregated by how each specific expense meets the in the MLR Report that ask whether market, while Part C and Part D MLR criteria for the type of expense in which each plan under a contract is a Special data is collected at the contract level. it is categorized. MAOs and Part D Needs Plan for beneficiaries who are Although the data is reported sponsors may provide information that dually eligible for both Medicare and differently, we do not believe these is pertinent to more than the individual Medicaid (D–SNP), or whether the differences are significant enough to MA or Part D contract for which the plan’s defined service area includes merit a different approach to the public MLR Report is being submitted (see, for counties in one of the territories. disclosure of data. example, § 422.2420(d)(1)(ii) and Third, at proposed § 422.2490(b)(3) We also believe that the availability of § 423.2420(d)(1)(ii), which requires that and § 423.2490(b)(3), we proposed to Part C and Part D MLR data will expenditures that benefit multiple exclude from release any information enhance the competitive nature of the contracts, or contracts other than those identifying Medicare beneficiaries or MA and Part D programs. The proposed being reported, be reported on a pro rata other individuals. This exclusion was access to data will support potential share), such as an MAO’s or Part D proposed for the same reason we new plan sponsors in evaluating their sponsor’s approach to setting payment proposed to exclude similar information participation in the Part C and Part D rates in contracts with providers, or its from MA bid submission data that will programs and will facilitate the entry strategies for investing in activities that be released: we believe that it is into new markets of existing plan improve health quality. We proposed to important to protect the privacy of sponsors. With knowledge of historical exclude this narrative information individuals identified in these MLR data, new business partners might because we believe that it is more submissions, particularly Medicare emerge, and better business decisions competitively sensitive than the beneficiaries. We explained that, might be made by existing partners. As contract-level figures that are used to consistent with our longstanding data a result, we believe that releasing Part populate the non-narrative fields in the release policy for protecting C and Part D MLR data as proposed is MLR Report. We are concerned that individually identifiable information, if both important and appropriate for the MAOs and Part D sponsors would be a data field in the MLR Report for an effective operation of these programs. reluctant to submit narrative MA or Part D contract is calculated Further, we believe that the release of descriptions that include information based on figures associated with fewer Part C and Part D MLR data, as that they regard as proprietary or than 11 enrollees (or 132 member described in this final rule, strikes the confidential if they know that it will be months, assuming each individual is appropriate balance between our goals disclosed to the public, which could counted for 12 months), we would for the release of Part C and Part D MLR impair our ability to assess whether suppress all the data from such fields in data and safeguarding information that the public release file for that contract. their allocation methods are could be commercially sensitive or Regarding other individuals, we appropriate. proprietary. Costs in the MLR numerator require that MAOs and Part D sponsors are aggregated across providers, Second, at proposed § 422.2490(b)(2) provide in their MLR Reports the names beneficiaries, and sites of service. Costs and § 423.2490(b)(2), we proposed to and contact information of individuals and revenues are further aggregated exclude from release any plan-level who can answer questions about the across all plans under the contract. We information that MAOs and Part D data submitted in an MLR Report. We do not believe that there is a realistic sponsors submit in their MLR Reports. proposed to exclude this information possibility that the MLR data we release Some of the plan-level data in MAO’s from release. We do not believe that the could be disaggregated or reverse and Part D sponsors’ MLR Reports is release of this information serves the engineered to reveal commercially also included in their plan bids as base purposes of our proposed release of sensitive or proprietary information. period experience data, such as plan certain MLR data, which are to provide We described the data we proposed to IDs, plan member months, and the public with data that can be used to exclude from the public release. We Medicaid per member per month gain/ evaluate MA and Part D contracts’ stated that we would exclude the loss. As discussed in our proposal to efficiency, and to provide beneficiaries following four categories of data from release certain MA bid pricing data, we with information that can be used to release: narrative information, plan- believe bid data would no longer be compare the relative value of Medicare level information (Part C MLR data and competitively sensitive after 5 years; plans. Further, release of this Part D MLR data that we will release is however, we do not believe that bid data identifying and contact information aggregated at the contract level), any becomes no longer competitively appears to be an unnecessary intrusion information identifying beneficiaries or sensitive within the 18-month into information about private other individuals, and any MLR review timeframe for our proposed release of individuals. correspondence. MLR data. Therefore, we proposed to Fourth, at proposed § 422.2490(b)(4) First, at proposed § 422.2490(b)(1) and exclude from release plan-level data that and § 423.2490(b)(4), we proposed to § 423.2490(b)(1), we proposed to is included as base period experience exclude from release any MLR review exclude from release any narrative data in plan bids. We also proposed to correspondence. In the course of the information that MAOs and Part D exclude the plan-level information MLR review process, our reviewers may sponsors submit to support the amounts submitted in MLR Reports because we engage in correspondence with MAOs that they include in their MLR Reports, do not regard it as relevant to the and Part D sponsors in order to validate such as descriptions of the methods purposes of our proposed release of Part amounts included in their MLR Reports. used to allocate expenses. MAOs and C and Part D MLR data, which include Such correspondence may include

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requests for evidence of amounts MAOs, and § 423.2400, which identifies Response: We appreciate the support. reported to us. Responses to these the basis and scope of the MLR Comment: Some commenters requests could include proprietary or regulations for Part D sponsors, to add suggested that Part C and Part D MLR confidential information, such as a reference to section 1106 of the Act, data would be unhelpful to the public, MAOs’ and Part D sponsors’ negotiated which governs the release of including researchers and beneficiaries, rates of reimbursement. We believe that information gathered in the course of because it could be misconstrued. A few such information is more competitively administering our programs under the commenters stated that release of Part C sensitive than the contract-level figures Act. and Part D MLR data as proposed would that are used to populate the non- We solicited comment on the release lead to misinterpretation and narrative fields in the MLR Report. of MLR data as outlined above. We also inappropriate comparisons across MA Further, we are concerned that, if we solicited comment on whether the Part or Part D contracts, causing erroneous were to publicly release this C and Part D MLR data we proposed to conclusions and misinformed policy correspondence, it could cause MAOs release contain proprietary information, decisions. Many commenters and Part D sponsors to be less and if so, what safeguards might be questioned whether the MLR data forthcoming in the information appropriate to protect those data, such would be valuable or useful to Medicare provided to us or our reviewers, which as recommended fields to be redacted, beneficiaries. would impede our access to information the minimum length of time that such Response: We appreciate the concerns that would we could use to verify the data remains commercially sensitive, raised. However, we continue to believe information submitted by MAOs and and any suggestions for publishing that releasing the MLR data is consistent Part D sponsors. aggregations of Part C and Part D MLR with the Administration’s commitment We proposed to release the MLR data data in lieu of publishing the MLR data to transparency. In addition, while specified in this rule for each MA and as submitted by MAOs and Part D Medicare beneficiaries have multiple Part D contract on an annual basis no sponsors. We invited commenters to tools available to assist them in earlier than 18 months after the end of provide analysis and explanations to evaluating MA and Part D plans, we the contract year to which the MLR data support comments that information continue to believe that beneficiaries applies. We proposed to follow the should be protected for a longer—or should have the opportunity to review commercial MLR approach in making shorter—period of time so that we could Part C and Part D MLR information as the data we receive in MLR Reports properly evaluate our proposal in an additional tool. We continue to available to the public. For Part C and adopting a final rule. Analysis and believe that making the MLR data Part D MLR reporting, the data is due explanations were requested to (1) cite available to the research community about 12 months after the end of the the particular information proposed to will spur research that could support contract year. After we receive MAOs’ be released and explain how that the goals of federal policymakers. and Part D sponsors’ MLR Reports, we information differs from publicly Furthermore, we believe it is important anticipate that it will take available data; (2) point to the particular to mirror the transparency created by approximately 6 months for us to review entity or entity type that could gain an the commercial MLR to the extent and finalize the data submitted by unfair competitive advantage from the possible. As commercial MLR data is MAOs and Part D sponsors. information release; and (3) fully already being released, our proposal to We recognize that the 18-month time explain the mechanism by which the release Part C and Part D MLR data is lag time for the release of Part C and Part release of that particular information the next step in maintaining D MLR data differs from the 5-year would create an unfair competitive consistency. delay used for the release of MA bid advantage for that particular entity. We Comment: Some commenters pricing data (discussed in section requested this level of detail in order to indicated that the commercial MLR data III.E.2.a of this final rule (‘‘Summary of substantiate the positions taken by that we release each year is Proposed Rule’’)). This difference in the commenters and to better inform our substantively different from the Part C length of the delay that applies to each rulemaking and decisions (81 FR and Part D MLR data, making the of these data releases reflects key 46403). decision to release Part C and Part D differences between the MA bid pricing MLR data one that should not be tied to data that we proposed to release in b. Comments the current disclosure of commercial accordance with § 422.272 and the Part The following is summary of the MLR data. Two commenters noted that C and Part D MLR data that we comments we received on our proposed because the MLR Reports for MAOs and proposed to in accordance with regulatory changes providing for the Part D sponsors are contract-based and § 422.2490 and § 423.2490. Most release of Part C and Part D MLR data. MLR Reports for issuers in the importantly, the Part C and Part D MLR Comment: Several commenters commercial market are state-based, the data that we proposed to release is expressed support for our proposal to Part C and Part D MLR Reports could be aggregated at the contract level, and we release Part C and Part D MLR data, confusing to consumers and subject to are excluding any plan-level data. The noting the benefits of transparency and misinterpretation. MA bid pricing data that we proposed advancing research, and improving Response: We acknowledge that there to release includes plan-level healthcare delivery, as well as the cost are differences between Part C and Part information. We believe that contract- of healthcare. A number of commenters D MLR data and commercial MLR data. level information is sufficiently also stated that release of Part C and Part However, we do not believe these aggregated such that it would be D MLR data would help beneficiaries differences are substantial enough to difficult to obtain an unfair competitive make informed choices when choosing merit withholding the Part C and Part D advantage from its review. For example, between health plans. Two commenters MLR data from public consumption we do not believe it is possible to added that releasing Part C and Part D when commercial MLR data is released reverse-engineer provider rates from MLR data would allow the public to see annually. Although there are some contract-level information. how MAOs and Part D sponsors differences between how the Part C and Finally, we proposed to amend administer Medicare and supplemental Part D MLR is reported in comparison § 422.2400, which identifies the basis benefits in an effective and efficient with the commercial MLR, in all cases, and scope of the MLR regulations for manner. the data is used to produce a final MLR

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ratio, and we continue to believe that any MLR data for a contract in a commenter requested further this data can be a valuable tool for contract year that the contract is clarification regarding the plan-level beneficiaries and researchers, as determined to be non-credible, as information that we are proposing to discussed earlier in this rule. defined in accordance with exclude. The commenter asked that we Comment: Several commenters § 422.2440(d) for MA contracts and state whether plan-level means at the expressed support for our proposed § 423.2440(d) for Part D contracts. plan benefit package (PBP) level or exclusions of certain data from our Although, as we explain more fully something else. proposed release of Part C and Part D below, we are adopting this new Response: We appreciate the MLR data, stating that aggregation and exclusion of non-credible contracts’ comments submitted, and have exclusions would help safeguard against MLR data for reasons other than the expanded the data exclusions to not the release of proprietary information. protection of proprietary information, release data for single-plan contracts, Response: We appreciate the support. we expect that this exclusion will since single-plan contract level data is Comment: Several commenters stated address concerns about competitive functionally the same as plan-level data. that the proposed release of Part C and harm for MAOs or Part D sponsors The exclusion of plan-level data would Part D MLR data would cause operating contracts with limited also apply to data that is captured by the significant competitive harm to plans in enrollment. section of the MLR Report that is the MA and Part D markets through the Comment: Several commenters asked labeled ‘‘Plan-Specific Data.’’ We disclosure of confidential and us to aggregate the data further or described the information collected in proprietary information. Some expand the list of exclusions before this section of the MLR Report in the commenters suggested the data in the release, in order to protect plans’ proposed rule at 81 FR 46404. We proposed release could provide insight proprietary and confidential explain above why the release of plan- into a plan’s strategies related to information. One commenter suggested level data that is as recent as 18 months provider agreements, pricing, or quality that we limit the release of MLR data to old could cause substantial competitive improvement activities. the aggregate categories that we listed in harm. Response: We appreciate the concerns the preamble of the proposed rule at 81 Comment: One commenter expressed raised by the commenters with respect FR 46404 (that is, ‘‘Revenue,’’ ‘‘Claims,’’ concern about the release of MLR data to protecting proprietary information. ‘‘Federal and State Taxes and Licensing for contracts with a limited number of We take very seriously the need to or Regulatory Fees,’’ ‘‘Health Care beneficiaries. This commenter suggested safeguard proprietary and confidential Quality Improvement Expenses,’’ and that we not release data for a contract in business information shared with the ‘‘Non-Claim Costs’’) and the MLR a year that the contract does not meet agency for purposes of participation in calculation itself, without releasing the the minimum credibility threshold of the MA and Part D programs. However, data for the component fields that make 2,400 member months for MA contracts we do not believe that the information up each of these categories. Another or 4,800 member months for Part D included in the proposed MLR release commenter requested that we exclude contracts. represents a threat to the competitive any part of the MLR substantiation, Response: We agree with the position of MAOs and Part D sponsors including but not limited to the commenter’s concern about releasing particularly as comparable data is narrative included in the substantiation. Part C and Part D MLR data for contracts already released for commercial plans. In addition, we received two comments that have non-credible experience. We Through the comment period and requesting that we not release Part C believe that publishing the MLR data for rulemaking process, we provided MAOs and Part D MLR data at a more granular a contract in a contract year in which it and Part D sponsors the opportunity to level than the contract level. This would has non-credible experience may be offer specific, detailed examples of how exclude the ‘‘Plan-Specific Data’’ misleading and cause incorrect the release of MLR data could lead to section of the MLR Report. Another assumptions. As such, we have added competitive harm. We do not believe commenter stated that if we believe it is an exclusion to our proposed release of any of the commenters provided such important for the public to further Part C and Part D MLR data to specify examples. Further, we believe that the understand the breakdown of how that we will not release the MLR data exclusions described in the final rule revenue is spent, then we could for a contract in any contract year in will help protect plans’ proprietary consider releasing only the percent of which the contract is determined to be information. revenue associated with incurred non-credible. This exclusion is added at However, to address concerns raised claims, quality improvement activities, § 422.2490(b)(5), with respect to Part C by commenters, we are expanding the and Part B premium rebates, in order to MLR data, and at § 423.2490(b)(5), with data that would be subject to exclusion. limit potential competitive harm. respect to Part D MLR data. First, we are revising our proposed Response: We appreciate the concerns Currently, MA contracts are exclusion of plan-level data at proposed raised by commenters, along with the considered to be non-credible if they § 422.2490(b)(2) and § 423.2490(b)(2) to proposed alternatives. We believe that have fewer than 2,400 member months, state that we will not be releasing any the list of exclusions provided in the and Part D contracts are considered non- MLR data submitted for contracts that final rule is sufficient to protect plans credible if they have fewer than 4,800 consist of only one plan. Contract-level against competitive harm. Where member months. In the February 23, data for single-plan contracts is possible, we have sought to mirror the 2013 proposed rule (78 FR 12428, equivalent to plan-level data, which we release policies for the commercial 12438–40), we explained our rationale regard as more competitively sensitive MLR, and we are not aware of any for taking into account the number of because it is at a lower level of evidence demonstrating that the release enrollees under a contract when aggregation. In expanding the exclusion of commercial MLR data has caused any assessing Part C and Part D MLRs, at proposed § 422.2490(b)(2) and competitive harm. We have also stating, ‘‘To avoid requiring MA § 423.2490(b)(2) to include MLR data broadened the data subject to exclusion, organizations and Part D sponsors to submitted for single-plan contracts, we as discussed above. pay remittances due to random claim are confirming our commitment not to Comment: Several commenters urged variation, rather than due to their release any plan-level MLR data. us to not release Part C or Part D MLR underlying pricing and benefits Second, we are excluding from release data for single-plan contracts. One structure, it is necessary to assess MLRs

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on sufficient numbers of member therefore, more useful to beneficiaries advantage for particular entities, such as months for statistical credibility.’’ In and researchers. new market entrants, who would have excluding from release MLR data Response: We appreciate the access to such data without having to submitted for contracts with non- commenter’s concern. The decision to release such data themselves. It is not credible experience, we recognize that follow an 18-month delay was not likely that entities, such as new market these contracts’ MLRs are more intended only for the purpose of entrants, could use aggregated data to vulnerable to the effects of random protecting proprietary interests. Part C reverse-engineer pricing strategies, variations in claims experience and may and Part D MLR data is typically not payments rates, or other competitively fail to reflect their efficiency or relative collected until the end of the year sensitive information. value. We wish to release MLR data that following the contract year (for example, Comment: One commenter urged us accurately and meaningfully reflects the contract year 2014 data was not to utilize established public data release value of MA and Part D plans; we do not collected until December 2015). We methodologies for the release of Part C believe that pro-active public release of must then review all submitted data for and Part D MLR data. A few MLR Reports for contracts that have completeness and accuracy before commenters also asked that we only non-credible experience furthers that determining whether MLRs are final. release data through ResDAC to goal. Therefore, we are finalizing the We continue to believe that the 18- researchers. rule with an exclusion for any MLR data month delay is appropriate, given these Response: Through the submitted for a contract in a year that operational constraints. Administration’s continued the contract is determined to be non- Comment: Several commenters commitment to transparency, we have credible. expressed concern that 18 months was significantly increased the amount of Comment: A small number of not a sufficient period of time to ensure Medicare data available to the public in commenters asked that we only release the release of data would not cause recent years, in part through the the final MLR for MA and Part D competitive harm. One commenter ResDAC portal. While we agree that contracts (that is, the ratio that is pointed out that because our revenue ResDAC is a valuable resource, we calculated by dividing the MLR settlement is 8 months after the close of believe that it is more appropriate in numerator by the MLR denominator), the year, and Part C and Part D MLR this instance to post the data directly to instead of the additional data included Reports are submitted at the end of that our Web site (cms.gov) for broader with MLR submissions. They stated that calendar year, MLR data would end up consumption. Because the data is this would fulfill our goal of increased being released only 6 months after the aggregated to the contract level, we do transparency, while protecting data is filed with CMS, not the 18 not believe there is a significant risk beneficiaries and researchers from months envisioned by the policy. associated with making the data more drawing incorrect conclusions, and Another commenter stated that data widely available. would safeguard confidential and generally does not change significantly Comment: A few commenters proprietary information that could hurt from year-to-year or across plans within expressed concern that we proposed competition. a contract, and therefore, neither releasing Part C and Part D MLR data in Response: We appreciate the aggregation at the contract level nor an the CY 2017 PFS proposed rule, rather suggestion. Given that we already 18-month delay of release will provide than through a Part C and Part D release annually the MLR data sufficient protection. Several rulemaking process. The commenters submitted by commercial plans, we commenters asked that we release Part stated that this approach increased the believe that it would be inconsistent to C and Part D MLR data using the same likelihood that many stakeholders release only the final MLR for MA and 5-year delay that was proposed for the would have been unaware of our Part D contracts. As previously release of bid data. A few commenters proposal in time to provide detailed discussed, we do not believe that added that releasing such competitively analysis of the impacts of the proposed differences between the Part C and Part sensitive information sooner than the 5- data releases, and one commenter D MLRs and the commercial MLR are year lag could potentially injure plans suggested reissuing this proposal in a significant enough to merit a different and the program by harming Parts C and D rulemaking. approach to the public disclosure of competition among MA plans and Response: The Administrative data. driving up costs. Procedure Act (APA) and section 1871 We have proposed appropriate Response: We believe that the of the Act generally require that rules be exclusions and safeguards to protect proposed 18-month delay of release of published in the Federal Register in proprietary business strategies. Part C and Part D MLR data will balance proposed form, with a basis and Completely excluding other information the need to make sure the data is purpose statement explaining the would not be consistent with the complete with the desire to provide proposal, and then published in the Administration’s commitment to beneficiaries and researchers with data Federal Register in final form, with transparency. that is meaningful and helpful in plan revisions based on comments received, Comment: Several commenters selection and research. We selected a 5- and responses to such comments. There expressed support for our proposal to year delay for bid pricing data because is no requirement governing how release MLR data on an annual basis no much of that data is collected at the proposed or final rules are packaged or earlier than 18 months after the end of plan level. Part C and Part D MLR data organized, as long as the public is given the contract year to which the MLR data is aggregated to the contract level, and proper notice. The proposed rule here applies. A few commenters stated that also includes a more limited range of clearly listed all Parts of the Medicare the proposed 18-month delayed release information. Further, as we have noted, regulations that would be affected by of MLR data would help balance the we do not believe that there will be the proposed regulations (including need for transparency and the potential competitive harm to MAOs or Part D parts 422 and 423) and its title included for competitive harm. plan sponsors as a result of the release a reference to release of Medicare Response: We appreciate the support. of MLR reports as provided under this Advantage and Part D data (‘‘. . . Comment: We received one comment rule. Contract-level data is, as described Medicare Advantage Pricing Data encouraging us to consider releasing above, sufficiently aggregated to avoid Release; Medicare Advantage and Part D MLR data that is more recent, and creating an unfair competitive Medical Low [sic] Ratio Data Release

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. . .’’), so there was adequate notice to beneficiaries enrolled in the Qualified (including QMBs) enrolled in Medicare the public of the content of the Medicare Beneficiaries (QMB) program Advantage plans and the responsibility proposed rule (81 FR 46162). That fully (a Medicaid program which helps of plans to adopt certain measures to satisfies the requirements of the APA certain low-income individuals with protect dual eligible beneficiaries from and section 1871 of the Act. Medicare cost-sharing liability). In July unauthorized charges under The presence of this rider was clearly 2015, we released a study finding that § 422.504(g). (See pages 181–183 at discussed in the title of the rule and in confusion and inappropriate balance https://www.cms.gov/Medicare/Health- the Fact Sheet that we released publicly billing persist notwithstanding laws Plans/MedicareAdvtgSpecRateStats/ at the time of the rule’s display. We prohibiting Medicare cost-sharing Downloads/Announcement2017.pdf). received 26 comments on our proposed charges for QMB individuals, Access to Although we did not solicit comments release of Part C and Part D MLR data Care Issues Among Qualified Medicare on this statement of current law and from across the industry, including a Beneficiaries (QMB) (‘‘Access to Care’’) policy, we appreciate the comments number of comments from MAOs, Part https://www.cms.gov/Medicare- received, which included comments D sponsors, and their trade associations. Medicaid-Coordination/Medicare-and- from national beneficiary advocacy This further demonstrates that adequate Medicaid-Coordination/Medicare- organizations, and professional, notice was provided. Medicaid-Coordination-Office/ insurance, and medical billing We also proposed to amend Downloads/Access_to_Care_Issues_ associations. § 422.2400, which identifies the basis Among_Qualified_Medicare_ Comment: Commenters concurred and scope of the MLR regulations for Beneficiaries.pdf. that confusion and improper QMB MAOs, and § 423.2400, which identifies These findings underscore the need to billing problems remain pervasive and the basis and scope of the MLR re-educate providers about proper affirmed their negative toll on regulations for Part D sponsors, to add billing practices for QMB enrollees. beneficiaries. Commenters were a reference to section 1106 of the Act, In 2013, approximately 7 million supportive of CMS’s expanded efforts to which governs the release of Medicare beneficiaries were enrolled in educate providers regarding QMB information gathered in the course of the QMB program. State Medicaid billing rules to reduce the incidence of administering our programs under the programs are liable to pay Medicare improper QMB billing. Some Act. After consideration of public providers who serve QMB individuals commenters also noted that Medicare comments received on the technical for the Medicare cost-sharing. However, providers encounter difficulties changes, we are finalizing these as permitted by federal law, states can discerning which patients are QMBs technical changes to § 422.2400 and limit provider payment for Medicare and advised CMS to adopt strategies to § 423.2400 as proposed. cost-sharing to the lesser of the help providers ascertain this After reviewing the comments we Medicare cost-sharing amount, or the information. Additionally, one received, we are choosing to finalize the difference between the Medicare commenter noted that the variation in proposed MLR data release with two payment and the Medicaid rate for the state policies to pay providers for modifications. First, we will revise the service. Regardless, as stated in the CY Medicare cost-sharing fuels confusion, exclusion at § 422.2490(b)(2), with 2017 proposed rule, Medicare providers frustration and compliance problems. respect to Part C MLR data, and at must accept the Medicare payment and Response: We continue to pursue § 423.2490(b)(2), with respect to Part D Medicaid payment (if any, and opportunities to educate providers and MLR data, to exclude from release any including any permissible Medicaid welcome partnering with commenters MLR data submitted for a single-plan cost sharing from the beneficiary) as and others in these efforts. Currently, contract. Second, we add a new payment in full for services rendered to Medicare providers must determine a exclusion at § 422.2490(b)(5), with a QMB individual. Medicare providers patient’s QMB status through respect to Part C MLR data, and at who violate these billing prohibitions information from State Medicaid § 423.2490(b)(5), with respect to Part D are violating their Medicare Provider agencies, including online eligibility MLR data, to exclude from release any Agreement and may be subject to systems and beneficiary identification MLR data submitted for a contract in a sanctions. (See sections 1902(n)(3), cards. We are actively exploring contract year for which the contract is 1905(p), 1866(a)(1)(A), and 1848(g)(3) of additional mechanisms for Medicare the Act.) determined to be non-credible, as providers to readily identify the QMB Additionally, as we stated in the CY defined in accordance with status of patients. § 422.2440(d) for MA contracts and 2017 proposed rule, Medicare providers § 423.2440(d) for Part D contracts. We should take steps to educate themselves G. Recoupment or Offset of Payments to continue to believe that the release of and their staff about QMB billing Providers Sharing the Same Taxpayer MLR data is consistent with the prohibitions and to exempt QMB Identification Number individuals from impermissible Administration’s directives regarding 1. Overview and Background the transparency of program data, and Medicare cost-sharing billing and we support public research that can related collection efforts. For more Medicare payments to providers and potentially strengthen the program. information about these requirements, suppliers may be offset or recouped, in steps to identify QMB patients and ways whole or in part, by a Medicare F. Prohibition on Billing Qualified to promote compliance, see https:// Administrator Contractor (MAC) if the Medicare Beneficiary Individuals for www.cms.gov/Outreach-and-Education/ MAC or CMS has determined that a Medicare Cost-Sharing Medicare-Learning-Network-MLN/ provider or supplier has been overpaid. As we stated in the CY 2017 proposed MLNMattersArticles/downloads/ Historically, we have used the Medicare rule, we remind all Medicare providers se1128.pdf. provider billing number or National (including providers of services defined Given that original Medicare Provider Identifier (NPI) to recoup in section 1861 of the Act and providers may also serve Medicare overpayments from Medicare providers physicians) that federal law prohibits Advantage enrollees, we again note that and suppliers until these debts were them from collecting Medicare Part A the CY 2017 Medicare Advantage Call paid in full or eligible for referral to the and Medicare Part B deductibles, Letter reiterates the billing prohibitions Department of Treasury (Treasury) for coinsurance, or copayments, from applicable to dual eligible beneficiaries further collection action under the Debt

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Collection Improvement Act of 1996 Medicare contractor to a provider or intermediaries and carriers no longer and the Digital Accountability and supplier serves as notification of the exist. Transparency Act of 2014. Once an overpayment and intention to recoup or The following is a summary of the overpayment is referred to Treasury, the offset if the obligated provider, Hospital comments we received on recoupment Treasury’s Debt Management Services A, fails to repay the overpayment in a or offset of payments to providers uses various tools to collect the debt, timely manner. sharing the same taxpayer identification including offset of federal payments With the passage of section 1866(j)(6) number. against entities that share the same of the Act, the requirements in Comment: One commenter disagreed provider Taxpayer Identification § 405.373(a) could be interpreted to with our assertion that there is no need Number (TIN). Hence, Treasury has the require the Medicare contractor to for its contractors to notify either party ability to collect our overpayments provide notification to both the when such a recoupment will be made. using the provider TIN and we pay a fee obligated provider, Hospital A, and the The commenter recommended that CMS for every collection made. applicable provider, Hospital B, of its should not finalize its proposal to On March 23, 2010, the Affordable intention to recoup or offset payment. eliminate notice to the applicable Care Act (ACA) was enacted. Section Because we don’t think it is necessary provider and the obligated provider in 6401(a)(6) of the Affordable Care Act to provide separate notice to both the the event of a recoupment of an established a new section 1866(j)(6) of obligated provider and the applicable overpayment. Response: We continue to believe it is the Act. Section 1866(j)(6) of the Act provider, we proposed to amend the not necessary to provide separate notice allows the Secretary to make any notice requirement in § 405.373. to both the obligated provider and the necessary adjustments to the payments Specifically, we proposed to create a applicable provider. We believe that to an applicable provider of services or new paragraph (f) in § 405.373 to state updating the Medicare Financial supplier to satisfy any amount due from that § 405.373(a) does not apply in Management Manual, as well as an obligated provider of services or instances where the Medicare including clarifying language in the supplier. The statute defines an Administrative Contractor intends to demand letters issued will provide applicable provider of services or offset or recoup payments to the sufficient notification to providers and supplier (applicable provider) as a applicable provider of services or suppliers sharing a TIN. In addition, we provider of services or supplier that has supplier to satisfy an amount due from believe the publication of this rule and the same taxpayer identification number an obligated provider of services or notification through a Medicare as the one assigned to the obligated supplier when the applicable and Learning Network article provides provider of services or supplier. The obligated provider of services or sufficient notice to providers and statute defines the obligated provider of supplier share the same Taxpayer suppliers sharing the same TIN and services or supplier (obligated provider) Identification Number. as a provider of services or supplier that allows these providers and suppliers Before the effective date of this rule, owes a past-due overpayment to the sufficient time to implement a tracking we intend to notify all potentially Medicare program. For purposes of this system of Medicare overpayments on a provision, the applicable and obligated affected Medicare providers of the corporate level, should they choose. providers must share a TIN, but may implementation of section 1866(j)(6) of Finally, offsetting using a TIN without possess a different billing number or the Act through Medicare Learning furnishing notice to all potentially National Provider Identifier (NPI) Network (MLN) or MLN Connects affected providers and suppliers is a number than one another. Provider eNews article(s). We also long standing practice used by Treasury For example, a health care system intend to update the current Internet to collect Medicare overpayments. may own a number of hospital providers Only Manual instructions including, the Comment: One commenter and these providers may share the same Medicare Financial Management recommended CMS recoup payments TIN while having different NPI or Manual, and the addition of clarifying based upon the combination of the TIN Medicare billing numbers. If one of the language in the demand letters issued to and individual NPI. hospitals in this system receives a obligated providers. We believe these Response: We do not believe the demand letter for a Medicare actions would provide adequate notice intent of section 1866(j)(6) of the Act is overpayment, then that hospital to providers and suppliers sharing a to use a combination of the TIN and (Hospital A) will be considered the TIN, if they choose, provide the individual NPI to offset Medicare obligated provider while its sister opportunity to implement a tracking overpayments. We view section hospitals (Hospitals B and C) will be system of Medicare overpayments on 1866(j)(6) of the Act as giving the agency considered the applicable providers. the corporate level for the affected the authority to recoup payments from This authority allows us to recoup the providers. We also believe these actions an applicable provider or supplier that overpayment of the obligated provider, are sufficient because of Treasury’s are due from an obligated provider or Hospital A, against any or all of the analogous practice of offsetting using a supplier that shares the same TIN. applicable providers, Hospitals B and C, TIN without furnishing notice to all Accordingly, we will finalize the rule as with which it, Hospital A, shares a TIN. potentially affected providers and proposed. suppliers. It has been a long standing 2. Provisions of the Proposed practice for Treasury to offset federal H. Accountable Care Organization Regulations payments using the TIN and Treasury (ACO) Participants Who Report If CMS or a Medicare contractor has currently does not issue a notice of Physician Quality Reporting System decided to put into effect an offset or intent to recoup or offset to applicable (PQRS) Quality Measures Separately recoupment, then § 405.373(a) requires providers and suppliers when Treasury The Affordable Care Act gives the the Medicare contractor to notify the recoups CMS overpayments. Secretary authority to incorporate provider or supplier in writing of its Additionally, in our review of reporting requirements and incentive intention to fully or partially offset or § 405.373(a) and (b), we proposed to payments from certain Medicare recoup payment and the reasons for the replace the terms intermediary and programs into the Shared Savings offset or recoupment. Currently, the carrier with the term Medicare Program, and to use alternative criteria written demand letter sent by the Administrative Contractor as to determine if payments are warranted.

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Specifically, section 1899(b)(3)(D) of the 2018 PQRS payment adjustments under the 2017 PQRS payment adjustment, Act affords the Secretary discretion to the Shared Savings Program at EPs who bill under the TIN of an ACO incorporate reporting requirements and § 425.504(d). We refer readers to section participant have the option of reporting incentive payments related to the III.K.1.e. of this final rule for a more separately as individual EPs or group physician quality reporting initiative detailed discussion of the proposed practices. As noted in this final rule, we (PQRI), under section 1848 of the Act, revisions to the requirements at proposed to amend § 425.504(c)(2) to including such requirements and such § 425.504 and the policies that are being apply only for purposes of the 2016 payments related to electronic finalized in this final rule. payment adjustment. We proposed to prescribing, electronic health records, In the proposed rule, we noted that include the revised requirements for the and other similar initiatives under the registration deadline for 2017 and 2018 PQRS payment section 1848, and permits the Secretary participating in the PQRS Group adjustments under the Shared Savings to use alternative criteria than would Practice Reporting Option (GPRO) is Program at § 425.504(d). We refer otherwise apply (under section 1848 of June 30 of the applicable reporting readers to the discussion of this the Act) for determining whether to period. Since affected EPs are not able proposal and the final policies that we make such payments. to register for the PQRS GPRO by the are adopting in section III.K.1.e. of this Current Shared Savings Program applicable deadline for the 2018 PQRS final rule. regulations at § 425.504(c) do not allow payment adjustment, we proposed that The previously established reporting eligible professionals (EPs) billing such EPs would not need to register for period for the 2017 PQRS payment through the Taxpayer Identification the PQRS GPRO for the 2018 PQRS adjustment is January 1, 2015, through Number (TIN) of an Accountable Care payment adjustment, but rather could December 31, 2015. To allow affected Organization (ACO) participant to mark the data as group-level data in EPs that participate in an ACO to report participate in PQRS outside of the their submission. Thus, we proposed to separately for purposes of the 2017 Shared Savings Program, and these EPs eliminate a registration process for PQRS payment adjustment, we and the ACO participants through groups submitting data using third party proposed at § 414.90(j)(1)(ii) to establish which they bill may not independently entities. When groups submit data a secondary PQRS reporting period for report for purposes of the PQRS apart utilizing third party entities, such as a the 2017 PQRS payment adjustment for from the ACO. This policy was designed qualified registry, qualified clinical data individual EPs or group practices who to ease reporting burden for individual registry (QCDR), direct Electronic bill under the TIN of an ACO EPs and group practices and promote Health Record (EHR) product, or EHR participant if the ACO failed to report integration of providers and suppliers data submission vendor, we are able to on behalf of such individual EPs or within the ACO in order to help achieve obtain group information from the third group practices during the previously the Shared Savings Program goals of party entity and discern whether the established reporting period for the improving quality and coordination of data submitted represents a group-level 2017 PQRS payment adjustment. We care. While over 98 percent of ACOs submission or an individual-level proposed that this option would be satisfactorily report their quality data submission once the data is submitted. limited to EPs that bill through the TIN annually, if an ACO fails to satisfy the In addition, we proposed that an of an ACO participant in an ACO that PQRS reporting requirements, the affected EP may utilize the secondary failed to satisfactorily report on behalf individual EPs and group practices reporting period either as an individual of its EPs and would not be available to participating in that ACO will receive EP using one of the registry, QCDR, EPs that failed to report for purposes of the PQRS payment adjustment along direct EHR product, or EHR data PQRS outside the Shared Savings with the automatic VM downward submission vendor reporting options or Program. payment adjustment. as a group practice using one of the In addition, we proposed that these We proposed to amend the regulation registry, QCDR, direct EHR product, or affected EPs may utilize the secondary at § 425.504 to permit EPs that bill EHR data submission vendor reporting reporting period either as an individual under the TIN of an ACO participant to options. We noted that this would EP using the registry, QCDR, direct EHR report separately for purposes of the exclude, for individual EPs, the claims product, or EHR data submission vendor 2018 PQRS payment adjustment when reporting option and, for group reporting options or as a group practice the ACO fails to report on behalf of the practices, the Web Interface and using one of the registry, QCDR, direct EPs who bill under the TIN of an ACO certified survey vendor reporting EHR product, or EHR data submission participant. Specifically, we proposed to options. vendor reporting options. We noted that remove the requirement at Furthermore, we recognized that this would exclude, for individual EPs, § 425.504(c)(2) so that, for purposes of certain EPs are similarly situated with the claims reporting option and, for the reporting period for the 2018 PQRS regard to the 2017 PQRS payment group practices, the Web Interface and payment adjustment (that is, January 1, adjustment, which will be applied certified survey vendor reporting 2016, through December 31, 2016), EPs beginning on January 1, 2017. We stated options. who bill under the TIN of an ACO that we believe it is appropriate and We note that the registration deadline participant have the option of reporting consistent with our stated policy goals for the participating in the PQRS GPRO separately as individual EPs or group to afford these EPs the benefit of this is June 30 of the applicable reporting practices. If the ACO fails to proposed policy change. Accordingly, as period. Since the applicable deadline satisfactorily report on behalf of such noted above, we proposed to permit EPs for the 2017 PQRS payment adjustment EPs or group practices, we proposed to that bill through the TIN of an ACO has passed, we proposed that such EPs consider this separately reported data participant to report separately for would not need to register for the PQRS for purposes of determining whether the purposes of the 2017 PQRS payment GPRO for the 2017 PQRS payment EPs or group practices are subject to the adjustment if the ACO failed to report adjustment, but rather would be able to 2018 PQRS payment adjustment. We on behalf of the EPs who bill under the report as a group practice via the also proposed to amend § 425.504(c)(2) TIN of an ACO participant. Specifically, registry, QCDR, direct EHR product, or to apply only for purposes of the 2016 we proposed to remove the EHR data submission vendor reporting payment adjustment. We proposed requirements at § 425.504(c)(2) so that, options. Therefore, we proposed at revised requirements for the 2017 and for purposes of the reporting period for § 414.90(j)(4)(v) that sections

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§ 414.90(j)(8)(ii), (iii), and (iv) would individual EP or group practice met the Response: We would like to clarify apply to affected EPs reporting as applicable satisfactory reporting that the elimination of the GPRO individuals using this secondary requirements for the 2018 PQRS registration process would only apply to reporting period for the 2017 PQRS payment adjustment. Third, we would EPs and groups that participate in ACOs payment adjustment. In addition, we need to update the individual EP or that fail to report on their behalf. proposed at § 414.90(j)(7)(viii) that group practice’s status so that the EP or Comment: One commenter stated that sections § 414.90(j)(9)(ii), (iii), and (iv) group practice stops receiving a negative affected EPs or group practices would would apply to affected EPs reporting as payment adjustment on claims for not be aware that the ACO did not group practices using this secondary services furnished in 2017 and satisfactorily report for purposes of the reporting period for the 2017 PQRS reprocess all claims that were 2018 PQRS payment adjustment and, payment adjustment. Further, we previously paid. In addition, as absent such information, would not proposed at § 414.90(k)(4)(ii) that discussed in the proposed rule, the EP choose to report outside the ACO during § 414.90(k)(5) would apply to affected or group practice would also avoid the the CY 2016 reporting period. Another EPs reporting as individuals or group automatic downward VM adjustment, commenter noted that many EPs in an practices using this secondary reporting but would not qualify for an upward ACO will not report data separately period for the 2017 PQRS payment adjustment since the ACO failed to during the reporting period if they are adjustment. report (81 FR 46446). operating under the assumption that We also proposed that the secondary Since EPs and group practices taking their ACO is reporting on their behalf. reporting period for the 2017 PQRS advantage of this secondary reporting In addition, other commenters urged payment adjustment would coincide period for the 2017 PQRS payment CMS to invest in strategies to prevent with the reporting period for the 2018 adjustment will have missed the these situations from occurring in the PQRS payment adjustment (that is, deadline for submitting an informal first place, such as providing ACOs with January 1, 2016 through December 31, review request for the 2017 PQRS more frequent feedback on their 2016). In addition, for operational payment adjustment, we proposed that reporting compliance throughout the reasons and to minimize any additional the informal review submission periods year. burden on affected EPs (who are already for these EPs or group practices would Response: We expect that any ACO that is unable to meet satisfactory required to report for CY 2016 for occur during the 60 days following the reporting requirements for any reason purposes of the 2018 PQRS payment release of the PQRS feedback reports for would inform the EPs participating in adjustment), we proposed to assess the the 2018 PQRS payment adjustment. individual EP or group practice’s 2016 the ACO in a timely and transparent We requested comments on these data using the applicable satisfactory manner to allow the EPs to report proposals. reporting requirements for the 2018 separately using the registry, QCDR, The following is summary of the PQRS payment adjustment (including, direct EHR or EHR data submission comments we received on ACO but not limited to, the applicable PQRS vendor reporting options. Therefore, if measure set). We invited comment on participants who report PQRS quality an EP or group practice has reason to any 2018 requirements that might need measures separately. believe their ACO may not report on to be modified when applied for Comment: The majority of their behalf in 2016, they have the purposes of the 2017 PQRS payment commenters supported CMS’s proposal ability to report separately for purposes adjustment. to allow affected EPs or group practices of the 2018 PQRS payment adjustment. As a result, individual EP or group to use CY 2016 as a secondary reporting In regards to providing ACOs with more practice 2016 data could be used with period for purposes of the 2017 PQRS frequent feedback on their reporting respect to the secondary reporting payment adjustment, in which case compliance, we provide many period for the 2017 PQRS payment such EPs or group practices should opportunities for ACOs to monitor their adjustment or for the 2018 PQRS expect to receive a PQRS payment progress toward the satisfactory payment adjustment or for both adjustment for services furnished in reporting requirement while the Web payment adjustments if the ACO in 2017 until CMS is able to determine that Interface is open for data collection. which the affected EPs participate failed the EP or group practice satisfactorily Throughout the data collection period, to report for purposes of the applicable reported for purposes of the 2017 PQRS and when the ACO has finished its payment adjustment. We explained that payment adjustment. In addition, the abstraction, ACOs may use reports we believe this change to our program commenters supported CMS’s proposal available in the Web Interface to rules is necessary for affected individual to allow EPs or group practices that bill confirm whether or not the Web EPs and group practices to be able to under the TIN of an ACO participant to Interface reporting requirements have take advantage of the additional report separately for purposes of the been met. Leading up to the data flexibility proposed for the Shared PQRS payment adjustment if the ACO collection period and during the data Savings Program (81 FR 46426 through fails to report on their behalf; the collection period, we provide frequent 45427). If an affected individual EP or commenters believed this proposal reminders to ACOs on the importance of group practice decides to use the provides flexibility for EPs and group reporting and how to satisfactorily secondary reporting period for the 2017 practices to avoid penalties under PQRS report. We also provide targeted PQRS payment adjustment, we and VM when ACOs fail to report the outreach to ACOs who have not entered explained that this EP or group practice data. Another commenter supported the data into the Web Interface in the final should expect to receive a PQRS proposal to retain the requirement that weeks of the data collection period, in payment adjustment for services an ACO satisfactorily report on behalf of an effort to ensure that all ACOs furnished in 2017 until CMS is able to the EPs who bill under the TIN of an completely report. determine that the EP or group practice ACO participant for purposes of the Comment: One commenter satisfactorily reported for purposes of PQRS payment adjustment. One acknowledged the difficulty in adding a the 2017 PQRS payment adjustment. commenter stated that they appreciated second reporting period for affected EPs First, we would need to process the data the elimination of the registration and group practices, and therefore, submitted for 2016. Second, we would process for groups using third party urged flexibility on the part of CMS to need to determine whether or not the entities. determine a way to provide an

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additional reporting period in 2017 for participating in the ACO in a timely and require information reported using purposes of the 2018 PQRS payment transparent manner to allow the EPs to QCDRs and EHRs to simultaneously adjustment for EPs and group practices report separately using the registry, meet the reporting requirements and that participate in ACOs that fail to QCDR, direct EHR or EHR data measures of multiple years. report for purposes of the 2018 PQRS submission vendor reporting options. Response: We would like to clarify payment adjustment. Another However, if an EP or group practice has that we are not requiring affected EPs or commenter encouraged CMS to allow reason to believe their ACO may not group practices to report the previous affected EPs and group practices to report on their behalf in 2016, they have year’s data. EPs or group practices that report PQRS data separately during the the ability to report separately for are taking advantage of the secondary year following the CY 2016 reporting purposes of the 2018 PQRS payment reporting period for the 2017 PQRS period in order for them to avoid adjustment. In addition, by permitting payment adjustment would be reporting penalties during the 2018 payment year. EPs and group practices to report data from CY 2016 and would be Response: As discussed in section separately from the ACO in such cases, assessed using the applicable reporting III.K.1.e. of this final rule, we are we are giving them flexibility to report requirements for the 2018 PQRS finalizing our proposal to remove the more directly relevant measures if they payment adjustment (including, but not requirement at § 425.504(c)(2) so that, so choose. limited to, the applicable PQRS measure for purposes of the reporting periods for Comment: One commenter supported set). In addition, we note that the PQRS the 2017 and 2018 PQRS payment CMS’s proposal to allow affected EPs to payment adjustment does not apply to adjustments, EPs who bill under the TIN report separately via a registry, QCDR, ACOs, and therefore, we cannot impose of a Shared Savings Program ACO direct EHR or EHR data submission a negative payment adjustment on the participant have the option of reporting vendor. ACOs when they fail to satisfactorily separately as individual EPs or group Response: We appreciate the report. practices. We disagree with the commenter’s support for our proposal. Out of Scope Comments commenter’s suggestions to establish a Comment: One commenter secondary reporting period for the 2018 recommended that for the CY 2016 We received a few comments for this PQRS payment adjustment, in addition reporting period: (1) In cases where section that are out of scope for this to the 2017 PQRS payment adjustment. measures data are submitted by both the final rule. We received comments We believe there is adequate time for EP and the ACO, the best performance pertaining to the following: (1) Support EPs or group practices to report should be counted and the EP should be for CMS’ proposal that EPs participating separately for the 2018 payment eligible for a positive payment in an ACO under the Shared Savings adjustment given that this final rule will adjustment; or (2) in cases where the EP Program that satisfy the CQM reporting be issued more than a month prior to does not opt to report outside the ACO, component of meaningful use for the the end of the reporting period for the and the ACO fails to report, the EP Medicare EHR Incentive Program when 2018 payment adjustment (that is, should receive a neutral payment the EP extracts data necessary for the January 1, 2016 through December 31, adjustment (that is, the EP should be ACO to satisfy the quality reporting 2016). held harmless from a negative payment requirements under the Shared Savings Comment: Several commenters stated adjustment and be ineligible for a Program from CEHRT and when the their support for CMS’s recognition of positive payment adjustment). ACO reports the ACO GPRO measures the individual commitment to quality Response: PQRS only assesses through the CMS Web Interface; (2) improvement of EPs in ACOs and CMS’s whether or not an EP or group practice recommendation that under MIPS, CMS proposals that would enable them to satisfactorily reported quality data or use the PQRS data (either submitted by avoid penalties in situations where their satisfactorily participated in a QCDR. the ACO or separately by the ACO ACO fails to meet satisfactory reporting PQRS does not apply positive payment participant) which would generate the requirements. The commenters stated adjustments or adjust payments based highest score for the quality that individual EPs and group practices on an EP or group practice’s performance category; and (3) requested are not in direct control of decisions or performance on the quality measures. guidance in the final rule for EPs, such actions taken by the larger ACO, and However, the VM does apply positive as rehabilitation therapists, who are therefore, should not be penalized. In payment adjustments and adjust currently subject to PQRS, but will not fact, the commenters stated that many payments based on the EP or group be subject to MIPS until 2021 at the EPs do not even know they are part of practice’s performance. We refer readers earliest. an ACO and prefer instead to report to section III.L.3.b. of this final rule for After consideration of the comments more directly relevant measures, such as a discussion of the VM policies in this received regarding our proposed those available through a QCDR. As an scenario. policies for EPs and group practices alternative to giving these EPs another Comment: One commenter stated that participating in ACOs that report PQRS opportunity to report data, a few reporting the previous year’s data is quality measures separately from the commenters believed that EPs should burdensome, particularly for registry ACO, we are finalizing the policies as instead be held harmless or provided a measures. The commenter believed that proposed. At § 414.90(j)(1)(ii), we are waiver from a negative payment requiring EPs to report separately from finalizing our proposal to establish a adjustment if the ACO fails to report. the ACO effectively penalizes the EP for secondary PQRS reporting period for the Response: We appreciate the the ACO’s error. Instead, the commenter 2017 PQRS payment adjustment for commenters’ support. However, we do suggested that CMS impose a negative individual EPs or group practices who not believe that EPs should be held payment adjustment on the ACOs when bill under the TIN of an ACO harmless or provided a waiver if the they fail to report. For the 2017 PQRS participant if the ACO failed to report ACO fails to report on their behalf. As payment adjustment, the commenter on behalf of such individual EPs or discussed above, we believe it is recommended that affected EPs be held group practices during the previously reasonable and appropriate to expect harmless by receiving no payment established reporting period for the that any ACO that is unable to meet adjustment. The commenter stated that 2017 PQRS payment adjustment. This satisfactory reporting requirements for retroactive reporting would be option is limited to EPs and group any reason would inform the EPs burdensome to the EPs and would practices that bill through the TIN of an

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ACO participant in an ACO that failed I. Medicare Advantage Provider provider or supplier that is currently to satisfactorily report on behalf of its Enrollment revoked from Medicare is not in an approved status. Out-of network or non- EPs and would not be available to EPs 1. Background and group practices that failed to report contract providers and suppliers are not for purposes of PQRS outside the a. General Overview required to enroll in Medicare to meet Shared Savings Program. We are The Medicare program is the primary the requirements of this final rule with finalizing our proposal that these payer of health care for approximately respect to furnishing items and services affected EPs may utilize the secondary 54 million beneficiaries and enrollees. to MA enrollees. reporting period either as an individual Section 1802(a) of the Act permits b. Background EP or as a group practice using one of beneficiaries to obtain health services the registry, QCDR, direct EHR product, from any individual or organization To receive payment for a furnished or EHR data submission vendor qualified to participate in the Medicare Medicare Part A or Part B service or item, or to order, certify, or prescribe reporting options. We are also finalizing program. Providers and suppliers certain Medicare services, items, and our proposal that such EPs do not need furnishing items or services must drugs, a provider or supplier must to register for the PQRS GPRO for the comply with all applicable Medicare requirements stipulated in the Act and enroll in Medicare. The enrollment 2017 PQRS payment adjustment. In process requires the provider or addition, we are finalizing at codified in the regulations. These requirements are meant to promote supplier to complete, sign, and submit § 414.90(j)(4)(v) our proposal that to its assigned Medicare contractor the sections § 414.90(j)(8)(ii), (iii), and (iv) quality care while protecting the integrity of the program. As a major appropriate Form CMS–855 enrollment would apply to affected EPs reporting as component of our fraud prevention application. The CMS–855 application individuals using this secondary activities, we have increased our efforts form captures information about the reporting period for the 2017 PQRS to prevent unqualified individuals or provider or supplier that is needed for payment adjustment. Further, we are organizations from enrolling in CMS or its contractors to screen the finalizing at § 414.90(j)(7)(viii) our Medicare. provider or supplier, verify the proposal that sections § 414.90(j)(9)(ii), The term ‘‘provider of services’’ is information provided, and determine (iii), and (iv) would apply to affected defined in section 1861(u) of the Act as whether the provider or supplier meets EPs reporting as group practices using a hospital, a critical access hospital all Medicare requirements. This this secondary reporting period for the (CAH), a skilled nursing facility (SNF), screening prior to enrollment helps to 2017 PQRS payment adjustment. We are a comprehensive outpatient ensure that unqualified individuals and finalizing at § 414.90(k)(4)(ii) our rehabilitation facility (CORF), a home entities do not bill Medicare and that proposal that § 414.90(k)(5) would apply health agency (HHA), or a hospice. The the Medicare Trust Funds are to affected EPs reporting as individuals term ‘‘supplier’’ is defined in section accordingly protected. Data collected or group practices using this secondary 1861(d) of the Act as, unless context and verified during the enrollment reporting period for the 2017 PQRS otherwise requires, a physician or other process generally includes, but is not payment adjustment. We are finalizing practitioner, facility or other entity limited to: (1) Basic identifying our proposal that the secondary (other than a provider of services) that information (for example, legal business reporting period for the 2017 PQRS furnishes items or services under title name, tax identification number); (2) state licensure information; (3) practice payment adjustment would coincide XVIII of the Act. Other supplier locations; and (4) information regarding with the reporting period for the 2018 categories may include, for example, ownership and management control. PQRS payment adjustment (that is, physicians, nurse practitioners, and We strive to further strengthen the January 1, 2016 through December 31, physical therapists. provider and supplier enrollment 2016). In addition, we are finalizing a Providers and suppliers that fit into these statutorily defined categories may process to prevent problematic policy under which we will assess the enroll in Medicare if they meet the providers and suppliers from entering individual EP or group practice’s 2016 proper screening and enrollment the Medicare program. This includes, data using the applicable satisfactory requirements. This final rule will but is not limited to, enhancing our reporting requirements for the 2018 require providers and suppliers in MA program integrity monitoring systems PQRS payment adjustment (including, organization networks and other and revising our provider and supplier but not limited to, the applicable PQRS designated plans (hereafter including enrollment regulations in 42 CFR 424, measure set). If an affected individual MA–PD plans, FDRs, PACE, Cost HMOs subpart P, and elsewhere, as needed. EP or group practice decides to use the or CMPs, demonstration programs, pilot With authority granted by the Act, secondary reporting period for the 2017 programs, locum tenens suppliers, and including provisions in the Affordable PQRS payment adjustment, the EP or incident-to suppliers) to be enrolled in Care Act, we have revised our provider group practice should expect to receive Medicare in an approved status. We and supplier enrollment regulations by a PQRS payment adjustment for services generally refer to an ‘‘approved status’’ issuing the following: furnished in 2017 until we are able to as a status whereby a provider or • In the February 2, 2011 Federal determine that the EP or group practice supplier is enrolled in, and is not Register (76 FR 5861), we published a satisfactorily reported for purposes of revoked from, the Medicare program. final rule with comment period titled, the 2017 PQRS payment adjustment. For example, a provider or supplier that ‘‘Medicare, Medicaid, and Children’s Further, we are finalizing our proposal has submitted an application, but has Health Insurance Programs; Additional that the informal review submission not completed the enrollment process Screening Requirements, Application periods for these EPs or group practices with their respective Medicare Fees, Temporary Enrollment Moratoria, would occur during the 60 days Administrative Contractor (MAC), is not Payment Suspensions and Compliance following the release of the PQRS enrolled in an approved status. The Plans for Providers and Suppliers.’’ This feedback reports for the 2018 PQRS submission of an enrollment application final rule with comment period payment adjustment. does not deem a provider or supplier implemented major Affordable Care Act enrolled in an approved status. A provisions, including the following:

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++ A requirement that institutional The public may review the Annual determine to have enough qualified providers and suppliers must submit Report to Congress on the Medicare and providers and suppliers with which to application fees as part of the Medicare, Medicaid Integrity Programs each year contract in order for enrollees to have Medicaid, and CHIP provider and for more information on program access to all Medicare Part A and Part supplier enrollment processes. integrity efforts, including how we B services, must develop a network of ++ Establishment of Medicare, calculate savings to the Medicare and qualified providers and suppliers that Medicaid, and CHIP provider and Medicaid programs. The Department of meet our network adequacy standards. supplier risk-based enrollment Health and Human Services (HHS), As a condition of contracting with us, screening categories and corresponding Office of Inspector General (OIG), the health plans’ contracted network of screening requirements. Government Accountability Office providers and suppliers must be ++ Authority that enabled imposition (GAO), and other federal agencies approved by us as part of application of temporary moratoria on the routinely review Medicare’s provider approval (§ 417.406). PACE enrollment of new Medicare, Medicaid, and supplier enrollment processes and organizations must furnish and CHIP providers and suppliers of a systems, including a recent study stating comprehensive medical, health, and particular type (or the establishment of that ‘‘as part of an overall effort to social services that integrate acute and new practice locations of a particular enhance program integrity and reduce long-term care in at least the PACE type) in a geographic area. fraud risk, effective enrollment- center, the participant’s home, or • In the April 27, 2012 Federal screening procedures are essential to inpatient facilities, and must ensure Register (77 FR 25284), we published a ensure that ineligible or potentially accessible and adequate services to meet final rule titled, ‘‘Medicare and fraudulent providers or suppliers do not the needs of its participants. Medicaid Programs; Changes in enroll in the Medicare program.’’ (GAO– Provider and Supplier Enrollment, 15–448) The enrollment screening Individuals receiving care through Ordering and Referring, and authorities granted in the Affordable MA organizations are typically referred Documentation Requirements and Care Act and used to prevent and detect to as enrollees, while in other parts of Changes in Provider Agreements.’’ The ineligible or potentially fraudulent the Medicare program, benefit recipients rule implemented another major providers and suppliers from enrolling are referred to as beneficiaries. This rule Affordable Care Act provision and in the Medicare program are working to does not change the proper meaning of required, among other things, that protect beneficiaries and the Medicare either term; however, for ease of providers and suppliers that order or Trust Funds. reading, the terms ‘‘beneficiary’’ and certify certain items or services be Under applicable provisions of the ‘‘enrollee’’ are used synonymously enrolled in or validly opted-out of the Tax Equity and Fiscal Responsibility throughout the preamble of this final Medicare program. Act (TEFRA) of 1982, Medicare began to rule. ++ This requirement was expanded to pay health plans on a prospective risk 2. Provisions of the Proposed Regulation include prescribers of Medicare Part D basis for the first time. The Balanced drugs in the final rule published in the Budget Act of 1997 (BBA) modified a. Need for Regulatory Action May 23, 2014 Federal Register (79 FR these provisions and established a new Part C of the Medicare program, known This final rule will require providers 29844) titled, ‘‘Medicare Program; or suppliers that furnish health care Contract Year 2015 Policy and as Medicare+Choice (M+C), effective January 1999. As part of the M+C items or services to a Medicare enrollee Technical Changes to the Medicare who receives his or her Medicare benefit Advantage and the Medicare program, the BBA authorized us to contract with public or private through an MA organization to be Prescription Drug Benefit Programs.’’ enrolled in Medicare and be in an Through improved processes and organizations to offer a variety of health plan options for enrollees, including approved status. The term ‘‘MA systems, since March 2011 we have: organization’’ refers to both MA plans • Saved over $927 million by both traditional managed care plans and also MA plans that provide drug revoking Medicare Part A and B (such as those offered by HMOs, as coverage, otherwise known as MA–PD providers and suppliers that did not defined in section 1876 of the Act) and plans. This final rule creates comply with Medicare requirements; new options not previously authorized. consistency with the provider and • Avoided over $2.4 billion in costs The M+C program was renamed the supplier enrollment requirements for all by preventing further billing from Medicare Advantage (MA) program other Medicare (Part A, Part B, and Part revoked and deactivated Medicare Part under Title II of the Medicare D) programs. We believe that this final A and B providers and suppliers; Prescription Drug, Improvement, and • Deactivated more than 543,163 Modernization Act of 2003 (MMA) (Pub. rule is necessary to help ensure that Medicare Part A and B providers and L. 108–173), which was enacted on Medicare enrollees receive items or suppliers that did not meet Medicare December 8, 2003. The MMA updated services from providers and suppliers enrollment standards; the choice of plans for enrollees under that are fully compliant with the • Revoked enrollment and billing MA and changed how benefits are requirements for Medicare enrollment privileges under § 424.535 for more than established and payments are made. In and that are in an approved enrollment 34,888 Medicare Parts A and B addition, Title I of the MMA established status in Medicare. This final rule will providers and suppliers that did not the Medicare prescription drug benefit assist our efforts to prevent fraud, waste, meet Medicare enrollment standards, (Part D) program and amended the MA and abuse and to protect Medicare and program to allow most types of MA enrollees by carefully screening all • Denied 4,949 applications for plans to offer prescription drug providers and suppliers, especially providers and suppliers in Medicare coverage. those that potentially pose an elevated Parts A and B that did not meet All Medicare health plans, with the risk to Medicare, to ensure that they are Medicare enrollment standards within a exception of PACE organizations, qualified to furnish Medicare items and recent 12-month period.14 operating in geographic areas that we services. Out-of-network or non-contract providers and suppliers are not required 14 Taken from Shantanu Agrawal, M.D. testimony www.aging.senate.gov/imo/media/doc/CMS%20_ to enroll in Medicare to meet the to Congress on July 22, 2015 http:// Agrawal_7_22_15.pdf. requirements of this final rule.

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We consider provider and supplier also result in improper Medicare The additional resources and oversight enrollment to be the gateway to the payments, harming the Medicare Trust that we provide in our processes for Medicare program and to beneficiaries. Funds and taxpayers. Requiring enrolling providers and suppliers will Requiring enrollment of those that wish enrollment allows us to have proper enhance and complement the screening to furnish items or services to MA oversight of providers and suppliers, processes that MA organizations already beneficiaries gives us improved making it more difficult for these types are required to perform. oversight of the providers and suppliers of providers and suppliers to enroll in b. Statutory Authority treating beneficiaries and the Medicare Medicare and remain enrolled in Trust Funds dollars spent on their care. Medicare. Furthermore, it allows us to The following are the principal legal However, Medicare has not historically remove a enrolled provider or supplier authorities for these provisions: • had direct oversight over all providers that does not comply with our rules Section 1856(b) of the Act provides and suppliers in MA organizations. We across Medicare (Part A, Part B, MA, that the Secretary shall establish by note that § 422.204 requires MA and Part D). regulation other standards for organizations to conduct screening of Information regarding a provider or Medicare+Choice organizations and their providers. We believe that we, supplier’s enrollment status is housed plans consistent with, and to carry out, through our enrollment processes, can in our enrollment repository called the this part. In addition, section 1856(b) further ensure that only qualified Provider Enrollment, Chain and states that these standards supersede providers and suppliers treat Medicare Ownership System (PECOS). A link to any state law or regulation (other than beneficiaries by conducting rigorous that information is located on the CMS those related to licensing or plan Web site. Initial data show a large solvency) for all MA organizations. screening and rescreening of providers • and suppliers that includes, for percent of MA providers and suppliers Sections 1102 and 1871 of the Act, example, risk-based site visits and, in are already enrolled in Medicare. We do which provide general authority for the some cases, fingerprint-based not believe that this final rule will have Secretary to prescribe regulations for the background checks. We also have access a significant impact on MA efficient administration of the Medicare organizations’ ability to establish program. to information and data not available to • MA organizations, making oversight to networks of contracted providers and Section 1866(j) of the Act, which ensure compliance with all federal and suppliers that meet CMS’ MA network provides specific authority with respect state requirements more robust. We also requirements. However, we solicited to the enrollment process for providers continually review provider and industry comment on the potential and suppliers in the Medicare program. supplier enrollment information from impact of this final rule on MA 3. Major Provisions organizations ability to establish or multiple sources, such as judicial and Given the foregoing and the need to law enforcement databases, state maintain an adequate networks of providers and suppliers. To clarify, this safeguard the Medicare program and its licensure databases, professional enrollees, we are finalizing most credentialing sources, and other systems rule only requires the enrollment of providers and suppliers that are of a provisions included in the proposed of record. In short, we collect and rule, with limited exceptions and carefully review and verify information provider or supplier type eligible to enroll in Medicare. Categorically- explained herein. prior to the provider’s or supplier’s Although existing regulations at enrollment and, of great importance, eligible providers and suppliers unable to meet the specific enrollment § 422.204 address basic requirements for continue this monitoring throughout the requirements are not exempt from this MA provider credentialing, we are period of enrollment. Section 422.204, rule. For example, if a clinical social finalizing the requirement in on the other hand, neither requires MA worker cannot meet an education § 422.204(b)(5) to require plans to verify organizations to, for instance, review a requirement as required by § 410.73, the that they are compliant with the provider or supplier’s final adverse clinical social worker cannot enroll provider and supplier enrollment action history (as defined in § 424.502), because he or she fails to meet program requirements. We believe this addition nor to verify a provider or supplier’s requirements. Therefore, this clinical would help facilitate MA organizations’ practice location, ownership, or general social worker may not provide items compliance. identifying information. and services to beneficiaries that receive In §§ 422.222, 417.478, 460.50, We believe that MA organization items and services through FFS, MA, 460.70, and 460.71 we are finalizing the enrollees should have the same MA–PD, PACE, and Cost plans, as well provisions requiring providers and protections against potentially as demonstration and pilot programs, suppliers to enroll in Medicare and be unqualified or fraudulent providers and regardless of whether the provider or in an approved status in order to suppliers as those afforded to supplier is listed on a specific claim for provide health care items or services to beneficiaries under the fee-for-service payment. a Medicare enrollee who receives his or (FFS) and Part D programs. Indeed, We believe that preventing her Medicare benefit through an MA Medicare beneficiaries and enrollees, questionable providers or suppliers organization. This requirement would the Medicare Trust Funds, and the from participating in the MA program apply to network providers and program at large, are at risk when and removing existing unqualified suppliers; first-tier, downstream, and providers and suppliers that have not providers and suppliers will help related entities (FDR); providers and been adequately screened, furnish, ensure that fewer enrollees are exposed suppliers participating in the Program of order, certify, or prescribe Medicare to risks and potential harm, and that All-inclusive Care for the Elderly services and items and receive Medicare taxpayer monies are spent (PACE); suppliers in Cost HMOs or payments. For instance, a network appropriately. Such a policy will also CMPs; providers and suppliers provider with a history of performing help comply with the GAO’s participating in demonstration medically unnecessary tests, treatments, recommendation that we improve our programs; providers and suppliers in or procedures could threaten enrollees’ provider and supplier enrollment pilot programs; locum tenens suppliers; welfare, as could a physician who processes and systems to increase the and incident-to suppliers. Based on a routinely overprescribes dangerous protection of all beneficiaries and the comment we received, we made a drugs. Lack of sufficient oversight could Medicare Trust Funds. (GAO–15–448). change from the proposed rule when

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finalizing a specific provision relating to in certain areas of the country. Some requiring MA organizations to provide the PACE program. Commenters were Cost HMOs or CMPs only provide assurance that the designated providers concerned that the requirement to coverage for Part B services. Cost HMOs and suppliers are properly screened and update PACE program agreements with or CMPs do not include Part D. These enrolled in Medicare. the name and NPIs of all enrolled plans are either sponsored by employer In § 422.504(a)(6), we are finalizing providers and suppliers was extremely or union group health plans or offered language with respect to contract burdensome based on the nature of the by companies that do not provide Part conditions. MA organizations must agreements and it imposed more of a A services. agree to comply with all applicable burden than was established for other Demonstrations and pilot programs, provider requirements in subpart E of plans and programs required to comply also called research studies, are special this part, including provider with this rule. Instead of requiring projects that test improvements in certification requirements, anti- PACE organizations to update the Medicare coverage, payment, and discrimination requirements, provider program agreement with the name and quality of care. They usually operate participation and consultation NPI of all providers and suppliers only for a limited time for a specific requirements, the prohibition on (§ 460.32), we added language to group of people and may only be offered interference with provider advice, limits § 460.70 and § 460.71 that better reflect only in specific areas. Providers and on provider indemnification, rules the enrollment requirements imposed suppliers in these programs would not governing payments to providers, and on MA organizations. We agree that we be exempt from the requirements of this limits on physician incentive plans. In can achieve the same program integrity final rule. § 422.504(a)(6), we are finalizing the goals, without the added burden of In §§ 422.224 and 460.86, we are extension of this requirement to having PACE organizations reflect this finalizing the prohibition on MA, PACE, suppliers. In this same section, we also information in the program agreement. the other designated programs and are finalizing the requirement for MA Based on a comment we received, we organizations from paying individuals organizations to comply with the also moved the requirement for PACE or entities that are excluded by the OIG provider and supplier enrollment that was included in 422.222 and or revoked from the Medicare program. requirements referenced in § 422.222. relocated it to better align with the These provisions also require MA, We believe these revisions would help PACE program. The requirements PACE, the other designated programs facilitate the MA organizations’ remain the same; however, the and organizations to notify the enrollee compliance with § 422.222. In enrollment requirements are now and the excluded or revoked provider or §§ 422.504(i)(2)(v), 417.484, 460.70, and contained in part 460. supplier that payment shall not be 460.71, we are finalizing provisions that We are finalizing the provisions in made. We are not, however, finalizing a require MA organizations, Cost plans, § 422.510, § 422.752, § 460.40, and first time allowance for payment. Based and PACE organizations to require all § 460.50 stating that organizations and on further analysis, we believe a first FDRs and contracted entities to agree to programs that do not ensure that time payment allowance would violate comply with the provider and supplier providers and suppliers comply with existing statute. However, we believe enrollment provision. the provider and supplier enrollment that beneficiaries are adequately Finally, the provisions are effective requirements may be subject to protected in these situations based upon the first day of the next plan year that sanctions and termination. Considering regulatory protections afforded at 42 begins 2 years from the date of the serious risks to the Medicare CFR 1001.1901(b) and § 424.555(b) that publication of the CY 2017 PFS final program and enrollees from fraudulent preclude OIG excluded individuals and rule. For PACE organizations, these or unqualified providers and suppliers, entities, as well as revoked, deactivated, requirements will be effective the first we believe that these are actions may be or Medicare enrollment denied day of the calendar year that is 2 years appropriate. providers or suppliers from recouping after the publication of this final rule. Current rules allow MA organizations payment from beneficiaries. We We believe this would give all to contract with different entities to continue to believe such excluded or stakeholders sufficient time to prepare provide services to beneficiaries. These revoked individuals and entities pose a for these requirements. We are unable to contracted entities are referred to as significant risk to enrollees and the impose new requirements on MA first-tier, downstream, and related Medicare program and should not organizations mid-year, and therefore, entities or FDRs, as defined in receive federal dollars, even if payment must wait to make these rules effective. § 422.500. FDRs must enroll to comply is made through an intermediary such The following is a summary of the with this rule. as an MA organization. Based upon the comments we received on MA provider PACE is a Medicare and Medicaid inclusion of PACE in § 422.222 in the enrollment. program that helps people meet their proposed rule, and our relocating the Enrollment File health care needs in the community PACE requirement to part 460, the instead of going to a nursing home or application of the prohibition to pay Comment: A commenter expressed other care facility, wherein a team of excluded and revoked providers and concern that CMS’ requirements for health care professionals works with suppliers also needs to be separately plan validation are overly burdensome. participants and their families to make designated. Therefore, in this final rule, The commenter noted that, as a sure participants get the coordinated the sections applicable to not paying condition of contracting with CMS, an care they need. A participant enrolled in excluded or revoked providers and MA organization would have to agree to PACE must receive Medicare and suppliers is now designated in § 460.86. provide documentation that all Medicaid benefits solely through the In § 422.501(c)(2), we are finalizing providers and suppliers in the MA or PACE organization. To ensure language requiring MA organization MA–PD plan who could enroll in consistency within our programs, we applications to include documentation Medicare were indeed enrolled. believe that our provider and supplier demonstrating that all applicable Believing that the providers themselves enrollment requirements should extend providers and suppliers are enrolled in should be involved in this process, the to this program. Medicare in an approved status. We commenter stated that providers should Medicare Cost HMOs or CMPs are a believe that this will assist CMS in the submit the required documentation to type of Medicare health plan available MA organization application process by CMS (as in the FFS program) and that

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CMS should in turn maintain a ‘‘source approach to providing information to through the Medicare FFS program and of truth’’ document for audit and plans, and we do not believe that MA that CMS include this figure and the compliance purposes. The commenter organizations need full access to PECOS associated cost in its regulatory burden stated that provider information can to obtain the information necessary to and Paperwork Reduction Act estimates. change frequently and become outdated; comply with this final rule. Regarding Response: We appreciate the without a ‘‘source of truth’’ to confirm revoked providers, providers or opportunity to clarify that these are the a provider’s enrollment in Medicare, the suppliers that are revoked from the exact figures reflected in the proposed commenter said, unintended program will not be included in the rule and in this final rule in the consequences could arise. enrollment file because they are not regulatory burden and Paperwork Response: We do not agree that this validly enrolled. Reduction Act sections. requirement is overly burdensome. We Comment: A commenter asked how Comment: A commenter asked that have made compliance simple by CMS will communicate with MA CMS: (1) Monitor the impact of these providing a file of enrolled providers organizations if it revokes a provider’s requirements on MA organization and suppliers. We maintain all provider or supplier’s enrollment and what steps networks and physician enrollment and, enrollment information in PECOS, our the MA organization would be required if negative effects are found, to either enrollment repository. In an effort to to take in response to the revocation. roll-back the requirement or implement provide MA organization with the Response: We will periodically appropriate changes; (2) create realistic necessary information, an online, public update our enrollment file made implementation timeframes and file listing enrolled providers and available to MA organizations. Providers comprehensive outreach plans; and (3) suppliers has already been made or suppliers that are revoked from the establish beneficiary financial available to MA organizations and will program will not be included in the protections during the transition. continue to be updated at a frequency to enrollment file because they are not Another commenter recommended that be determined and announced through validly enrolled. MA organizations will CMS improve its enrollment processes established processes such as a be expected to check the enrollment file so that those affected can enroll in a Medicare Learning Network (MLN) to ensure all providers and suppliers are timely manner. article. We believe this approach will validly enrolled and may not have an Response: We appreciate the provide MA organizations with unenrolled provider and supplier in commenters’ suggestions and will take sufficient access to the necessary their network. As we move toward these suggestions into consideration as provider enrollment information for the implementation, we will provide we move forward with operational relevant requirements under this final subregulatory guidance with respect to plans. rule. In addition, providers and revoked providers and suppliers. Comment: A commenter asked suppliers will be required to submit Comment: A commenter asked whether CMS has conducted a documentation to a CMS contractor, whether our proposed enrollment preliminary assessment of the potential consistent with current Medicare requirement represents a mere nationwide impact this requirement. enrollment processes. clarification of § 422.204(b)(2)(i), which Response: We have made that Comment: Several commenters asked outlines the provider credentialing assessment, and it is reflected in our how CMS will communicate provider process, or constitutes a new and Regulatory Impact Analysis. and supplier information to individual expanded process that MA Comment: A commenter sought MA organizations so that they can organizations must address in their clarification on how the provisions of remain compliant with our proposed policies and contracting processes. If it § 422.222 would improve program requirement. Another commenter asked is the latter, the commenter requested integrity and quality of care. how CMS will verify the inclusion or specific information on the ‘‘source of Response: This final rule would assist exclusion of enrolled providers and truth’’ and the method for MA our efforts to prevent fraud, waste, and suppliers. Several commenters stated organizations to verify this information abuse and to protect Medicare enrollees that if CMS finalizes its proposed (for example, whether MA organizations by carefully screening all providers and requirement, it must grant the MA will have to confirm the enrollment suppliers, especially those that organizations full access to PECOS so statuses of providers and suppliers via potentially pose an elevated risk to they can confirm a provider’s or a CMS Web site or whether CMS will Medicare, to ensure that they are supplier’s enrollment status. A furnish a list of enrolled providers and qualified to furnish Medicare items and commenter recommended that CMS suppliers to the MA organizations). services. These requirements are not a make publicly available a list of all Response: This requirement is not a clarification of § 422.204(b)(2)(i), but Medicare revocations, including the mere clarification of § 422.204(b)(2)(i) impose additional requirements on date and reason for the revocation. but imposes additional requirements on plans to ensure that their providers and Several commenters suggested that MA plans to ensure that their providers and suppliers are screened and enrolled in organizations be given access to PECOS suppliers are screened and enrolled in Medicare. Requiring enrollment of those or some other means of verifying an MA Medicare. These requirements are an that wish to furnish items or services to provider’s or supplier’s enrollment in expansion of § 422.204(b)(2)(i). MA beneficiaries gives us improved Medicare. This would, they contended, Verification of enrollment can be found oversight of the providers and suppliers reduce the burden on the plans and help by accessing the online enrollment file treating beneficiaries and the Medicare ensure the plans’ compliance with the we have provided to the public, which Trust Fund dollars spent on their care. requirements of § 422.222. will be updated to reflect changing Prior to this rule, Medicare did not have Response: We have created a public enrollment data. direct oversight over all providers and file that will be regularly updated with suppliers furnishing items and services provider and supplier enrollment Authority and Burden to enrollees of MA organizations. information at a frequency to be Comment: A commenter suggested Section 422.204 requires MA determined and announced through that CMS estimate the number of organizations to conduct screening of established processes such as a MLN providers and suppliers that furnish their providers. We believe that we can, article. As mentioned previously, we care to Medicare beneficiaries through through our enrollment processes, believe this is an efficient and sufficient an MA organization only and not conduct more robust verification of the

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information provided during enrollment In addition, the commenter encouraged Based upon our analysis of unenrolled so that only qualified providers and CMS to ensure that health plans are providers and suppliers that only suppliers treat Medicare beneficiaries by consulting the OIG exclusion list to provide services for MA organizations conducting rigorous screening and guarantee that physicians who have and do not bill Medicare FFS, we do not rescreening of providers and suppliers, been convicted of crimes are not in the believe there will be network adequacy risk-based site visits and fingerprint- MA networks. issues or beneficiary access issues. based background checks. We also have Response: We appreciate the Regarding the commenter’s concern that access to information and data not commenter’s concerns; however, we Medicare enrollment and screening is a available to MA organizations, making respectfully disagree and believe that FFS solution and is improper for the oversight to ensure compliance with all our enrollment screening processes (for MA program, we note that MA federal and state requirements more example, risk-based site visits and organizations’ requirements for robust. These checks prevent certain fingerprint-based background checks) screening providers and suppliers are providers and suppliers from furnishing help to ensure that qualified providers similar to Medicare screening and items and services to beneficiaries, such and suppliers treat Medicare enrollment in that MA organizations as a doctor convicted of a felony for beneficiaries. We conduct rigorous have requirements to, for example, abusing patients. While we are hopeful screening and rescreening of providers perform site visits, check licensure, and that licensing boards would take action and suppliers. We also have access to to complete background checks. to prevent providers and suppliers such information and data that is not However, MA organizations have as this from lawfully providing services available to MA organizations, which discretion in administering their to patients in the future, we cannot enhances enrollment screening and screening and verification procedures. always rely on the boards to take the helps ensure that providers and The Medicare enrollment process is action we believe is appropriate when suppliers are in compliance with all much more robust and provides serving beneficiaries. We believe that federal and state requirements. heightened consistency to the MA MA organization enrollees should have Moreover, we also continually review organizations’ screening processes and the same protections against potentially provider and supplier enrollment also allows for screening using unqualified or fraudulent providers and information from multiple sources, such databases that are not available to MA suppliers as those afforded to as judicial, law enforcement, state organizations. beneficiaries under the FFS and Part D licensure, professional credentialing, As discussed in the preamble, a recent programs. Our program integrity and other databases for which MA GAO study stated that ‘‘as part of an concerns are furthered by having the organizations do not have access. In overall effort to enhance program ability to easily consolidate data across short, we collect and verify information integrity and reduce fraud risk, effective all lines of Medicare to see billing prior to the provider’s or supplier’s enrollment-screening procedures are patterns and schemes for a particular enrollment and, of great importance, essential to ensure that ineligible or provider or supplier. For example, a continue this monitoring throughout the potentially fraudulent providers or network provider with a history of period of enrollment. Section 422.204, suppliers do not enroll in the Medicare performing medically unnecessary tests, on the other hand, neither requires MA program.’’ (GAO–15–448) This study’s treatments, or procedures could threaten organizations to, for instance, review a recommendations did not specifically enrollees’ welfare, as could a physician provider or supplier’s final adverse recommend MA provider and supplier action history (as defined in § 424.502), enrollment; however, these new who routinely overprescribes dangerous nor to verify a provider or supplier’s provisions are part of an overall plan to drugs. This could also result in practice location, ownership, or general ensure standard screening for those improper Medicare payments, harming identifying information. providers and suppliers treating MA the Medicare Trust Funds and Comment: A commenter questioned beneficiaries. Evidentiary support for taxpayers. A benefit of enrolling all the need for our proposal by stating that improved care for beneficiaries can be providers and suppliers in Medicare is CMS did not provide empirical seen by reviewing the Annual Report to the ability to remove a provider or evidence of problems in MA for which Congress on the Medicare and Medicaid supplier for failure to meet our our enrollment requirement would be Integrity Programs, which gives more requirements or violates federal rules appropriate or fully address the information on program integrity efforts and regulations. Not only is the provider proposal’s impact on network adequacy and administrative actions. This report or supplier unable to bill a particular and potential downstream beneficiary demonstrates statistical evidence of the MA organization, but they also may not access issues. The commenter stated judicial and administrative actions bill any other plan, bill Medicare, order that the requirement is a FFS solution taken against providers and suppliers, and certify Medicare items and services, developed for FFS program integrity such as, licensure suspensions, felony or prescribe Part D drugs. issues and is improper for the MA convictions, and Medicare revocations. Comment: A commenter opposed our program. The commenter urged CMS to Comment: A commenter proposed enrollment requirement, withdraw the proposal and work with recommended that CMS identify the stating that it would be redundant in plans to develop solutions that are types of oversight it currently uses to that all payers have rigorous screening better applicable to the MA program. ensure that MA organizations do not and rescreening processes, as well as Another commenter suggested that CMS have unlicensed or fraudulent providers programs to ensure quality and cost cite the specific OIG or GAO reports that and suppliers participating in their effectiveness. The commenter also recommend that MA providers and network. stated that: (1) physician quality data is suppliers be enrolled in Medicare FFS Response: These regulatory transparent and made available through and furnish evidence that our proposed requirements are specified at § 422.204 payer Web sites and portals to provide requirement would improve care for MA and impose obligations on plans. members with the opportunity to choose beneficiaries. Comment: A commenter highly rated qualified physicians; and Response: We believe that the recommended that CMS streamline and (2) MA plans should be responsible for vulnerabilities identified by the GAO improve the enrollment process before ensuring that they are enrolling the most (GAO–15–448) provide sufficient implementing its proposed MA qualified physicians into their networks. justification to impose this requirement. enrollment requirements. Another

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commenter urged CMS to administer the provides that the Secretary shall layouts while developing a mechanism enrollment requirements in a manner establish by regulation other standards to require providers to update their that limits the burden on physician for Medicare+Choice organizations and taxonomy codes. practices as much as possible. plans ‘‘consistent with, and to carry out, Response: We appreciate this Response: We appreciate the this part.’’ In addition, section 1856(b) comment and will continue our ongoing commenters’ concerns and have taken of the Act states that these standards work to minimize burden on MA steps to make the enrollment process as supersede any state law or regulation organizations, as well as providers and streamlined as possible, but we do not (other than those related to licensing or suppliers, while ensuring that an believe that implementation should be plan solvency) for all MA organizations. effective and efficient enrollment delayed. The application process, We have also relied on sections 1102 process, as well as outreach and especially for physicians and physician and 1871 of the Act, which provide education efforts, exist to operationalize practices, requires the provision of basic general authority for the Secretary to the requirements under this final rule. information that should be easily prescribe regulations for the efficient Comment: A commenter expressed obtained, such as name, NPI, practice administration of the Medicare program. concern that certain contractual locations, licensure number, criminal Section 1866(j) of the Act gives us arrangements that are currently required history, and education. We do not specific authority with respect to the for SNFs under Medicare Parts A and B believe that furnishing this information enrollment process for providers and might be disallowed under the proposed will be overly burdensome for providers suppliers in the Medicare program. rule. The commenter stated that SNFs and suppliers. Moreover, this Our justification for broadening our are statutorily required under information provides great value in enrollment requirements is based upon consolidated billing to submit charges assessing the risk to beneficiaries and a desire for MA organization enrollees for certain ancillary services, such as the program. Consequently, we decline to have the same protections against rehabilitation therapy and portable x-ray to delay the requirements in this rule. potentially unqualified or fraudulent services as a part of the nursing facility’s Comment: A commenter urged CMS providers and suppliers as those institutional claim; that is, Medicare to work with plans so that an informed afforded to beneficiaries under the FFS Part B requires that the nursing facility assessment of the potential impact of and Part D programs. We believe that bill Medicare for these services. The our proposed requirements can be robust screening is fundamentally commenter sought clarification on the developed before the rule is finalized. important to promote quality of care. question of contractual disallowance, Response: We remain committed to Medicare beneficiaries and enrollees, given the proposed rule’s objectives of working with plans to help them the Medicare Trust Funds, and the achieving consistency between MA and understand and be compliant with these program at large, are at risk when Medicare Parts A and B and whether requirements; however, we decline to providers and suppliers that have not such ancillary service providers must delay implementation. We have been adequately screened furnish, order, reviewed all public comments and certify, or prescribe Medicare services enroll as Medicare providers. considered the potential impacts and items and receive Medicare Response: This rule does not address provided by commenters and internal payments. Requiring enrollment allows the payment arrangements described by stakeholders prior to finalizing this rule. us to have proper oversight of providers the commenter. We note that Part A and Comment: Several commenters and suppliers, making it more difficult B providers and suppliers are already opposed CMS’ proposal. One for these types of providers and required to enroll in Medicare. These commenter stated that it represents a suppliers to enroll in Medicare and provisions only provide for regulatory overreach and asked CMS to remain enrolled in Medicare. requirements for the Medicare cite the legal authority for the proposal, Furthermore, it allows us to remove a enrollment of MA organization explain our justification for the provider or supplier that does not providers and suppliers and prohibition proposal, and identify the specific comply with our rules across Medicare of payment in certain circumstances problem the proposal is intended to (Part A, Part B, MA, and Part D). such as an OIG exclusion or Medicare resolve. The commenter stated that CMS We believe the GAO report cited revocation. did not furnish evidence that MA herein provides specific examples and Plan Noncompliance providers are unqualified or fraudulent evidence of our need to standardize the and suggested that CMS provide enrollment process and take advantage Comment: A commenter contended examples of where (1) an MA provider of the information available to Medicare that sanctioning or terminating plans for or supplier was not licensed to practice that the MA organizations cannot non-compliance with our enrollment medicine and where the MA access. We believe the enrollment file requirements is too aggressive. The organization did not take the provides an efficient way for the plans commenter stated that plans will need appropriate action to terminate the to ensure that providers and suppliers to ensure that systems are updated with provider or supplier; (2) CMS has taken are enrolled, which will minimize current provider information and that a compliance action against an MA burden on plans. new information can be received and organization for failing to exclude Comment: A commenter expressed reviewed in a timely manner. The unlicensed or fraudulent providers or concern that some of the operational commenter stated that legitimate errors suppliers from their network; and (3) challenges encountered in CMS’ could arise throughout the process, and CMS imposed civil money penalties or implementation of the Part D prescriber that rather than immediately sanction or sanctions on an MA organization for its enrollment requirement could also terminate a plan (which would have failure to protect its members from occur during implementation of a negative consequences on its members), unlicensed or fraudulent providers or similar requirement in MA. The CMS should instead put into place a suppliers. Other commenters stated that commenter urged CMS to implement its process for remediation. Plans that are the proposed requirement would be MA enrollment requirement in a consistently found to be in non- overly burdensome on plans and manner that avoids such issues. compliance with the rules, the providers. Specifically, the commenter urged CMS commenter said, should face Response: Our legal authority is based to improve application processing enforcement action, but first time upon section 1856(b) of the Act, which timeframes, test file protocols, and file ‘‘offenders’’ should be given the

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opportunity to work through challenges care, that plans should not be Comment: A commenter requested with both CMS and providers. sanctioned for ensuring that more explicit definitions of the terms Response: We will work with MA beneficiaries are protected in these ‘‘provider’’ and ‘‘supplier,’’ particularly organizations and all other stakeholders cases, and that appropriate exceptions in the context of Medicare-Medicaid as we move forward with would need to be developed. plans (MMPs), which the commenter implementation. We have discretion in Response: We will work with MA stated would not otherwise qualify for determining the appropriate action to organizations and all other stakeholders Medicare enrollment but furnish needed take for noncompliant plans, such that as we move forward with services to MMP members; the any remedial actions or penalties implementation. We have discretion in commenter believed that such providers imposed on plans that do not comply determining the appropriate action to should be excluded from our proposal. with the requirements of this rule will take for noncompliant plans, such that Response: As stated in the preamble be the result of thorough analysis of all any remedial actions or penalties of the rule, those terms are defined in relevant factors. Furthermore, we have imposed on plans that do not comply sections 1861(u) and 1861(d) of the Act. provided the stakeholders with more with the requirements of this rule will We are only requiring enrollment for than 2 years to make the changes be the result of a thorough analysis of providers and suppliers that are necessary to accommodate this all relevant factors. Furthermore, we categorically-eligible to enroll in requirement. have provided the stakeholders with Medicare. This rule is not requiring Comment: A commenter asked more than 2 years to make the changes MMP plans to enroll. whether beneficiary complaints about necessary to accommodate this Comment: A commenter the MA organization due to the impact requirement. recommended that CMS clarify whether of the enrollment requirement (for our proposal applies to providers and example, the beneficiary can no longer Clarification and Exemptions suppliers furnishing services to a receive covered services from a non- Medicare beneficiary through the Comment: A commenter enrolled provider) will affect a plan’s Railroad Retirement Board or the recommended that CMS explain Star Rating. The commenter believed it Indirect Payment Procedure (IPP) under whether a DMEPOS supplier that would be unfair to penalize plans that § 424.66 and, if so, that CMS adjust the services Medicare beneficiaries through are merely attempting to comply with regulatory impact analysis accordingly. an MA organization, a cost contract plan CMS’ enrollment requirement. Response: This particular rule is not Response: We do not expect the under section 1876 of the Act, or a applicable to the Railroad Retirement requirements of this final rule to have a health care pre-payment plan under Board or the IPP. significant impact on Star Ratings, given section 1833 of the Act will be subject Comment: A commenter requested the relatively few number of providers to surety bonding, accreditation, and clarification as to whether the proposed and suppliers that need to enroll to meet other DMEPOS provisions contained in requirements add MA provider the requirements of this rule. Issues the Medicare FFS program. The enrollment burdens that extend beyond regarding the potential impact that commenter also asked how CMS will the current FFS enrollment process beneficiary complaints have on plans’ address access-to-care issues when such requirements. Star Ratings will be addressed by CMS DMEPOS suppliers are unable to Response: No, the enrollment in future guidance. Furthermore, any comply with § 424.57 and §§ 424.500– requirements do not extend beyond our remedial actions or penalties imposed 424.570. Another commenter current requirements. Providers and on MA organizations that do not comply recommended that CMS clarify whether suppliers that are already enrolled in with the requirements of this rule will Part A providers serving Medicare Medicare for purposes of billing the be the result of thorough analysis of all beneficiaries through an MA Medicare program, rather than enrolled relevant factors. organization, a section 1876 cost to order, refer, certify, or prescribe, have Comment: A commenter sought contract plan, or a section 1833 health met the enrollment requirements for this clarification as to the extent an MA care pre-payment plan must obtain a rule and are compliant. Part A providers organization may be subject to contract CMS survey or accreditation to enroll in and suppliers that are validly enrolled termination, intermediate sanctions, or Medicare FFS. in the Medicare program do not need to civil monetary penalties. Response: All providers and suppliers separately enroll to meet the Response: It is difficult to predict, that enroll in Medicare are subject to the requirements of this rule. In-network prior to our enforcement of these Medicare enrollment requirements, as providers and suppliers that are not provisions, how and when we will use assigned by their provider or supplier already enrolled in Medicare and that these sanctions. We cannot yet assess type. For example, provider and are currently providing services to MA plans’ compliance with this requirement supplier types subject to surety bonding enrollees will need to enroll in and the steps they will take to become are required to obtain a surety bond to Medicare to continue to provide those compliant. We will consider issuing complete the enrollment process. There services to MA enrollees. guidance in the future related to this are no exceptions to the enrollment Comment: A commenter asked how rule. requirements based on this rule. If a our proposed requirement applies to Comment: Several commenters CMS survey or accreditation is required providers and suppliers for MMPs. The expressed concern about the potential for a particular provider or supplier commenter stated that these plans might penalties for plans that do not adhere to type, it must comply in order to enroll. have atypical providers and suppliers our enrollment requirements. One We do not anticipate any issues with that would be unable to enroll in commenter stated that data or other regard to access to care based on the Medicare but provide needed care to system issues might prevent plans from relatively small number of providers MMP members. The commenter having complete and accurate and suppliers that need to enroll to meet recommended that such providers be information about a provider’s or the requirements of this rule. If there are excluded from this requirement. supplier’s status at a certain point in access to care issues, the plans will Response: This rule specifies time. The commenter added that it may follow established protocols to ensure requirements for providers and be critical for beneficiaries to retain all beneficiaries have access to needed suppliers that provide services to access to a provider for continuity of items and services. beneficiaries enrolled in MA, MA–PD,

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PACE, and Cost plans, as well as Comment: A commenter asked for ensuring that the entire staff or all demonstration and pilot programs. The whether there would be a the employees of such organizations requirements also apply to FDRs, locum grandfathering provision or grace period (including nurses, medical students, tenens, and incident-to suppliers. To the for un-enrolled MA providers and interns and residents of a facility or extent that MMPs are MA or MA–PD suppliers. other ancillary personnel, others in a plans they would be subject to these Response: We believe that the provider’s office, or in an inpatient requirements. We are not providing any effective date of the provisions of this setting that the MA organization does exemptions and are only requiring rule and length of time we have allowed not directly contract with for the enrollment in Medicare for providers for plans to comply with these provision of services) are enrolled. and suppliers that are categorically- provisions provides enough time for Another commenter recommended that eligible to enroll in Medicare. providers and suppliers to enroll. We do these requirements be limited to MA Comment: A commenter asked not believe that providing a grace period first tier contracted providers and whether providers associated with FDRs or a grandfathering provision would facilities that provide basic Medicare A, would need to be enrolled in Medicare, serve the goals of ensuring consistent B, and D benefits and that the scope of even if they are not directly engaged in screening. those needed to enroll be scaled back providing services to plan members. Comment: A commenter significantly. The commenter cited the example of recommended that CMS clarify Response: We are using the dentists and expressed concern that a proposed § 422.222 to state that definitions for first-tier, downstream, requirement for dentists to enroll in enrollment in Medicare in an ‘‘approved and related entities in § 422.500. The Medicare to participate in an MA status’’ includes providers and suppliers MA organizations will be responsible network would threaten beneficiary that are deactivated for lack of claims for ensuring that the providers and submission. access to a supplemental dental benefit suppliers that are required to enroll, are Response: Providers and suppliers that many members have as part of their indeed enrolled. that are deactivated are not considered Comment: A commenter sought MA benefit package. In general, the in an approved status. Deactivated clarification as to whether the rule commenter urged CMS to clarify which providers and suppliers may reactivate would extend existing requirements for providers are affected by the provision, their enrollment by contacting their Part A and B providers to MA and how providers associated with Medicare Administrative Contractor and organization networks, rather than FDRs are to be treated in this respect. following the applicable reactivation requiring expanded screening for Response: FDRs, such as dentists, will procedures which are set forth in our subcontracted providers. need to enroll to meet the requirements enrollment regulations at § 424.540(b). Response: The rule extends Parts A of this rule. All providers and suppliers Comment: A commenter and B enrollment requirements to MA that are categorically-eligible to enroll in recommended that the proposed MA organization networks including other Medicare must enroll in Medicare in an enrollment requirement for in-network providers and suppliers, such as FDRs. approved status in order to meet the providers and suppliers extended to Comment: A commenter stated that requirements of this final rule. A out-of-network providers; the because Medicare FFS does not offer a determination as to whether a provider commenter believed this would help dental benefit, CMS should not require or supplier is eligible to enroll will be ensure that all MA beneficiaries have MA organizations to adhere to the based on the type of provider or access to fully screened and qualified standard of mandating that dentists supplier. For example, if an audiologist providers and suppliers. enroll as MA suppliers in order to works for a PACE organization or an Response: We appreciate the provide dental care to MA beneficiaries. FDR, he or she would need to enroll in commenter’s support and suggestion. Another commenter sought clarification Medicare because an audiologist is a Because we did not propose an concerning the impact of the enrollment type of provider or supplier eligible to expansion to out-of-network providers requirement on supplemental providers enroll. Furthermore, section and suppliers, we are not able to finalize that are not covered by Medicare Part A 1861(ll)(4)(B) of the Act states that a that in this rule. We proposed including or Part B. The commenter cited the qualified audiologist must have a only in-network providers and suppliers example of dental services, which are masters or doctoral degree in audiology, in this rule to ensure only a minimal often included as part of a supplemental among other requirements. If the impact to beneficiaries. We may services package; the commenter asked audiologist cannot enroll because he or consider future rulemaking to address whether dentists who are in-network she fails to meet program requirements, the commenter’s concerns. with MA organizations would be such as this educational requirement, he Comment: A commenter requested required to enroll in Medicare. The or she may not enroll in the program or clarification as to whether the proposed commenter urged CMS to consider (1) provide services to beneficiaries enrollment requirement extends to whether extending its enrollment enrolled in programs under this final employees and contracted services requirement to dentists and other rule. It does not mean that providers furnished through properly enrolled and affected supplemental service providers and suppliers, that are of the type of approved Medicare providers of is in the best interest of beneficiaries providers or suppliers eligible to enroll services, including SNFs; that is, and (2) delaying such a requirement for in Medicare, are exempt from enrolling whether such employees or contractual providers of supplemental services until because they cannot or do not meet the professionals or agencies of providers CMS gains experience and understands necessary requirements for their specific meet the definition of FDRs. The the effects of the requirement on Part A provider or supplier type to enroll in commenter stated that, under FFS and Part B providers, and can make any Medicare. Providers and suppliers that Medicare, there is no requirement that modifications needed to ensure access. cannot or do not meet the enrollment professional employees or contracted Response: We appreciate the requirements may not provide items and professionals or agencies of a properly commenter’s recommendations; services to beneficiaries that receive enrolled provider of services, such as a however, we are committed to ensuring items and services through FFS, MA, SNF, must be independently enrolled in that beneficiaries receive items and MA–PD, PACE, and Cost plans, as well FFS. Another commenter asked whether services from providers and suppliers as demonstration and pilot programs. MA organizations will be responsible that are the categorical types of

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providers and suppliers eligible to requiring them to enroll in Medicare; valuable purpose in protecting enroll, that are subject to uniform the commenter cited as an example beneficiaries and safeguarding the Trust screening processes, including when PBMs, which do not provide covered Funds and will help reduce the burden receiving dental services or other health care services but instead arrange on MA organizations as we move services not covered by Medicare in Part for their provision. The commenter forward with operationalizing this A or Part B. encouraged CMS to make clear that only policy. However, we note that we Comment: A commenter stated that those entities that meet the definition of currently do not have a process in place our proposed requirement is too broad, a Medicare ‘‘provider’’ or ‘‘supplier’’ to enroll pharmacies for the purpose of citing as examples its application to would be required to enroll in Medicare dispensing drugs, except in very limited locum tenens suppliers and incident-to in order to provide services to MA circumstances, such as for Part B drugs. suppliers. In particular, the commenter beneficiaries. We are working on operationalizing stated that MA beneficiaries may receive Response: This provision does not such a process for network pharmacies covered Medicare services from non- change enrollment parameters in MA–PD plans that do not provide contracting and/or out-of-network concerning the types of providers and only those limited Part B benefits to providers in the case of a local or suppliers eligible to enroll in Medicare. enroll in Medicare to be able to comply regional preferred provider organization The commenter is correct that only with this rule. We recognize that plans (PPO), or from hospitals and physicians providers and suppliers meeting those can be compliant only to the extent that not under contract with the MA statutory definitions will be required our enrollment requirements and organization for urgent or emergency and allowed to enroll in Medicare. processes in place allow at any given services; MA organizations, the Comment: Concerning the term time. commenter stated, generally have no ‘‘Medicare-covered services’’ as Comment: A commenter asked relationships to physician staffing referenced in the rule, a commenter whether our proposed requirement will organizations for correctional facilities sought clarification as to whether the impact coverage determinations. The or government and military facilities, enrollment requirement only applies to comment stated that, with respect to the yet they are listed as having the MA providers and suppliers of Medicare Part D enrollment requirement, there is requirements apply to them. The Part A, B, MA, and D covered benefits uncertainty regarding the actions that commenter contended that this is a and not to other services potentially Part D sponsors must take upon requirement that appears to be placed offered by an MA organizations, such as receiving a coverage determination on MA organizations, rather than on the routine eye care services, dental request from a non-enrolled prescriber traditional Medicare program, but that services, wellness programs, and other or beneficiary regarding a claim that is MA organizations cannot be, and should non-Medicare covered services. denied solely because of that enrollment not be, required to carry out functions Response: To clarify, we did not use requirement. that may belong to the Medicare the term ‘‘Medicare-covered services’’ in Response: This rule establishes program overall. If Medicare wants to either the preamble or the regulation requirements that services provided to widen its scope of providers enrolled in text with respect to these specific Medicare beneficiaries by MA Medicare for the purpose of expanding provisions of the rule. However, we organizations must be provided by its program integrity program, the expect all providers and suppliers that providers and suppliers that are commenter stated, Medicare’s are categorically-eligible to enroll in enrolled in Medicare. This rule does not enrollment efforts should be housed in Medicare and that fall under the address any other criteria affecting a single source or database, not merely requirements of this rule, to enroll in coverage determinations. in MA organizations. Medicare if they wish to participate in Comment: A commenter requested Response: The rule specifically the MA program. This includes that CMS exempt emergency medicine applies to network providers and providers and suppliers of dental, eye physicians from the enrollment suppliers, including locum tenens and care, and other supplemental services. requirements. The commenter added incident-to suppliers. We are unsure of Comment: Several commenters that if this were not feasible, CMS at a what the commenter means by stating recommended that CMS exclude minimum should: (1) establish a that the MA organizations are required pharmacies from the MA enrollment provision similar to § 423.120(c)(6) that to carry out functions that belong to the requirement, stating that pharmacies are would allow CMS to provide Medicare program. Consistent with excluded from the Part D prescriber reimbursement for covered items, existing enrollment practices, enrollment requirement. Other services or drugs ordered, certified, enrollment will be completed by our commenters stated that Part D sponsors referred or prescribed by emergency MACs, and all enrollment data will be and their FDRs are equipped to perform medicine physicians on a provisional housed in our enrollment repository, the necessary vetting and credentialing basis (for example, for a period of 90- PECOS. Information on a provider or with respect to pharmacy providers, days from the date of service); and (2) supplier’s enrollment status will be which, one commenter contended, was exclude from the enrollment available on a public file for ease of the rationale for excluding pharmacies requirements those providers whose access to the plans. We do not agree that from the Part D enrollment requirement. enrollment applications are pending the application of this rule is too broad. The commenter stated that the same with the Medicare Administrative We have limited the provisions to in- considerations apply in the MA program Contractor (MAC). network providers and suppliers. and added that applying the proposed Response: We have not provided for Furthermore, we believe it is important requirement to pharmacies would create any exemptions; however, we have a that all beneficiaries have the benefits of costly, burdensome, and potentially provision in § 422.224 that provides for being treated by providers and suppliers disruptive redundancies without allowances for some payments for that have been adequately screened by commensurate benefits. emergency or urgently needed services, the Medicare program. Response: We decline to exempt as defined in § 422.113. We also Comment: A commenter stated that pharmacies or other individuals or appreciate the suggestion that we the proposed rule could be entities that fall within the framework of exclude providers and suppliers with misconstrued as treating all FDRs as this rule. We believe that requiring pending applications from our Medicare providers and suppliers, thus enrollment in Medicare serves a requirements. We believe that the rule

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furnishes sufficient time for providers Response: As we work towards the or receive payment for items or services and suppliers to enroll to meet the implementation date, we will continue that violate federal law. requirements of this rule and decline to to monitor beneficiary impact. The Comment: A commenter stated that provide an exemption in these public should be aware of the CMS must assess the impact of our circumstances. provisions in § 422.224 regarding proposed requirement on beneficiaries. Comment: A commenter asked for prohibition of payment for excluded or The commenter specifically asked how more information regarding the revoked individuals or entities. This the requirement will be explained to providers and suppliers that are covered rule also does not change beneficiaries’ beneficiaries and whether beneficiaries under this proposal; the commenter ability to ask for a coverage themselves will have to pay for services specifically sought clarification determination prior to receiving an item obtained from a non-enrolled provider regarding providers and suppliers that or service if they are unsure of a (for example, an out-of-network PPO are not currently subject to credentialing provider or supplier’s enrollment status. provider) if they were unaware of the (such as hospital-based providers) and The issue of beneficiary liability enrollment requirement. only provide supplemental benefits that resulting from an OIG exclusion is Response: As we work towards the are not part of the basic benefits under addressed in 42 CFR 1001.1901(b). The implementation date, we will continue Medicare Parts A and B. issue of beneficiary liability resulting to assess beneficiary impact, though we Response: Regarding the commenter’s from revoked providers and suppliers, believe that based on the low number of inquiry, neither category of provider deactivated providers and suppliers, or providers and suppliers that need to would be exempt from the requirements enrollment denials is addressed in enroll, this impact will be small. This of this provision simply based on those § 424.555(b). Any needed additional rule applies to in-network providers and factors. If a provider or supplier falls clarification of this provision will be suppliers and other providers and into the categories articulated in the provided in subregulatory guidance. suppliers listed herein. This rule does rule, there will be no exemptions Comment: A commenter noted the not modify existing rules on out-of- provided. provision to prohibit MA organizations network providers and suppliers; from paying individuals or entities that however, the public should be aware of Concerns for Beneficiaries are excluded by the OIG or revoked the provisions in § 422.224 regarding Comment: A commenter stated that if from Medicare. Citing the requirement prohibition of payment for excluded or CMS terminates a contract with an MA that the MA organization in such cases revoked individuals or entities. This organization for failing to meet provider must notify the physician and the rule also does not change beneficiaries’ enrollment requirements or payment beneficiary that no future payment will ability to ask for a coverage prohibitions, CMS should allow made beyond the first one, the determination prior to receiving an item impacted patients to continue with their commenter stated that the notification or service if they are unsure of a physicians on an in-network basis until may only reach the beneficiary after provider or supplier’s enrollment status. the next enrollment period, with the numerous services have been provided Operations physician’s consent. The commenter and billed. The commenter expressed said that effectively requiring a concern that either the beneficiary or Comment: A commenter stated that beneficiary to find a new provider in the the physician would be without CMS should engage in robust provider middle of an enrollment period with reimbursement or payment for the and practice education to ensure that little advanced notice could be subsequent services provided before enrollment updates are implemented extremely disruptive and harmful to the notification was received. efficiently and without complication. Response: We appreciate the enrollee’s health. Response: We understand the suggestion and will incorporate this into Response: We will follow existing concerns of the commenter and do our operational plan. protocols and rules regarding believe it is important for MA Comment: A commenter asked CMS beneficiary care if CMS terminates a organizations and the other programs to address the claims and coding contract with an MA organization. and plans that fall within the context of technical components that CMS will Beneficiary care and access are always this rule to notify beneficiaries and implement for our proposed of the highest concern when providers and suppliers that payments requirement. determining contract action. will not be made. However, after further Response: We will issue subregulatory Furthermore, we have access to tools analysis, we are not able to finalize the guidance that addresses this issue. other than contract termination to first time payment provision that was Comment: A commenter asked CMS ensure MA organizations are compliant proposed because all payments to to clarify the components of its provider with this rule. excluded individuals or entities is education campaign. Comment: A commenter expressed prohibited. Beneficiaries have the Response: We will issue subregulatory concern about the potential financial ability to ask for a coverage guidance detailing educational efforts in impact on beneficiaries if a provider or determination prior to receiving an item the future as we move forward in supplier requests payment (1) for or service if they are unsure of a operationalizing this program. multiple beneficiaries at once, or (2) for provider or supplier’s enrollment status. Comment: A commenter suggested Medicare beneficiaries after notification The issue of beneficiary liability that CMS explain how it will that the provider or supplier is revoked resulting from an OIG exclusion is communicate provider and supplier from Medicare. The commenter addressed in § 1001.1901(b). The issue information to individual MA recommended that CMS clarify that of beneficiary liability resulting from organizations so that the latter can beneficiaries would not be financially revoked providers and suppliers, remain compliant with our responsible in these cases. Overall, the deactivated providers and suppliers, or requirements and identify the types of commenter urged CMS to ensure that enrollment denials is addressed in enforcement actions it will take against beneficiaries are financially protected § 424.555(b). All individuals and an MA organization that permits an and do not lose access to care during the entities that are excluded or revoked are unenrolled provider or supplier to transition phase as providers enroll in notified of their exclusion or revocation furnish care in an MA setting. The Medicare. status, and therefore, should not request commenter asked us to list all of the

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enforcement actions imposed against signing the provider to a 5-year contract assistant becomes a ‘‘hidden’’ provider, MA providers and suppliers based on for network participation; (2) if the which the commenter stated is contrary the provider being unqualified or provider fails to notify the MA to CMS’ goal of proper attribution to the fraudulent. organization of changes to its Medicare health professional who furnished the Response: We will continue to enrollment status, whether the plan is service. The commenter stated that MA provide outreach and education to the responsible for all payments made to the organization should be required to provider and supplier community about provider beginning as of the date of enroll relevant health professionals, these enrollment requirements and will disenrollment; (3) if a provider’s including physician’s assistants, and work with our stakeholders, including Medicare enrollment status changes and mandate the inclusion of the MA organizations, to assist them in the plan removes the provider from its appropriate professional’s NPI on a ensuring compliance. Specific network, whether and what claim. operational plans and guidance are consequences would ensue if this Response: The term ‘‘enrollment’’ is forthcoming as we move towards results in the plan failing network specific to enrollment in Medicare. The operationalizing this policy. Regarding adequacy requirements; and (4) whether enrollment data repository is PECOS. enforcement actions, we have provided there are requirements concerning We believe the commenter is referring to a number of options and have discretion continuity of care with respect to incident-to services. Incident-to when determining the appropriate providers that lose Medicare status. suppliers and locum tenens suppliers action to take for noncompliant plans. Response: The requirements of this are also required to enroll in Medicare, Those specific sanctions and contract rule require that after the effective date, meaning that the supplier actually actions are in existing policy. MA and MA PD plans must ensure that furnishing the service, not only the Comment: A commenter supported only enrolled providers and suppliers billing supplier, must be enrolled. We our proposed requirement to notify the are providing services to Medicare believe that this is an important step in enrollee when the provider’s or beneficiaries who are enrolled in their addressing the concerns of the supplier’s enrollment is revoked from plans. We have developed informational commenter and may consider future Medicare but encouraged CMS to ensure tools—the list of enrolled providers and rulemaking to further prevent the that such notices are consumer-friendly. suppliers referenced in several places scenario offered by the commenter. Another commenter urged CMS to throughout this rule—that further Network Adequacy furnish additional details on how plans support plans’ ability to meet these are to operationalize these new requirements and not rely on Comment: A commenter expressed requirements in a format that allows notification by providers in ensuring concern that the enrollment requirement plans to provide feedback on the compliance. Based on the small number would unduly burden physical proposed processes. of providers and suppliers that need to therapists, which could harm access to Response: We appreciate the enroll to comply with the provisions of physical therapy services as MA commenter’s support and will use the this rule, we do not believe this organizations struggle to find physical suggestion to help operationalize this requirement will cause network therapy providers for their networks. policy. adequacy issues. As to the frequency Response: This rule seeks to ensure Comment: Regarding proposed with which the plans will be expected that beneficiaries receive care from § 422.224, a commenter asked whether to update their records, further guidance providers and suppliers that have been ‘‘first time allowance’’ for payment is a will be provided as we operationalize uniformly screened. We have found requirement or is at the discretion of the this requirement; however, it is relatively few physical therapists that MA organization. anticipated that the plans will be are not already enrolled in Medicare. Response: After further legal analysis, expected to update their records with Therefore, we do not believe this will we have determined that we lack the the same frequency that the applicable have an impact on network adequacy. authority to allow a first time payment online files are updated. This rule does Comment: A commenter granted in the proposed § 422.224. not require providers and suppliers to recommended that CMS proceed with Therefore, MA organizations have no notify the plans, as the enrollment its enrollment requirement for only a discretion and may not pay an status on the file will change. This rule limited number of providers and individual or entity that is excluded by also does not change any rules regarding suppliers at first, specifically, for those the OIG or revoked from the Medicare continuity of care. provider types for which MA program. Comment: A commenter sought organizations are required to maintain Comment: Regarding proposed clarification regarding whether CMS’ adequate networks, as specified in the § 422.501, a commenter sought use of the term ‘‘enrollment’’ indicated Health Services Delivery Guidance that clarification regarding the method of enrollment in the Medicare program CMS issues each contract year. submission and the frequency of checks, through PECOS or an MA organization’s Response: We believe the and how this process differs from the enrollment of health professionals for requirements should be implemented current standard attestation process. the purpose of identifying them as simultaneously and have structured our Response: Further information and legitimate health professionals on efforts to accomplish that task. As we direction on this provision will be claims. The commenter expressed have stated throughout this rule, we issued in subregulatory guidance. concern that if Medicare enrollment is think the timeframe afforded plans for Comment: Stating that the proposed required without a concomitant compliance coupled with the relatively requirement contains no specifications requirement that the MA organization small number of providers and for how often plans would be required enroll the provider or supplier, CMS suppliers that are not already enrolled to confirm the status of a network risks perpetuating the concealment of in Medicare will allow plans to ensure provider, a commenter sought certain types of health professionals. that all necessary providers and clarification on the following issues: (1) Citing the example of physician suppliers can be enrolled and there are Whether a plan has met its obligations assistants, the commenter stated that no access issues. under the proposed requirements if, for when an MA organization requires that Comment: A commenter requested example, the plan confirms the a physician’s assistant bill under a clarification regarding what MA provider’s enrollment status before physician’s name, the physician’s organizations must do if the termination

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of providers or suppliers from the plan’s rule how its MA enrollment policies do significant impact on LTSS caregivers network results in network adequacy not inadvertently exclude long-term because of the relatively small number deficiencies. services and supports (LTSS) caregivers of providers and suppliers that need to Response: Based on the small number who cannot presently bill Medicare enroll. Furthermore, some of the LTSS of providers and suppliers that need to directly. Another commenter also caregivers are not of a provider or enroll to comply with the provisions of expressed concern about the rule’s effect supplier type that is eligible to enroll in this rule, we do not believe this on LTSS caregivers. Medicare. requirement will cause network Response: This rule only requires the Comment: A commenter expressed adequacy issues. However, MA enrollment of providers and suppliers concern about our proposal to amend organizations should use existing that are of a type this are eligible to § 460.32 to require that the PACE resources and processes to address any enroll. Staff members that are not of a program agreement include the name network adequacy concerns. provider or supplier type that is eligible and NPI of providers and suppliers Comment: A commenter stated that to enroll, are not subject to this rule. A reflecting enrollment in Medicare. The the administrative steps involved in determination on if a provider or commenter stated that the program enrolling in Medicare will deter some supplier is eligible to enroll will be agreement is a three-way agreement physicians from entering into MA based on the type of provider or between CMS, the state, and the PACE arrangements, thereby potentially supplier. For example, if a clinical organization, and that any change to the impacting the plan’s network adequacy social worker works for a PACE agreement would require the three and beneficiary access to care. parties to reenter and resign the organization, he or she would need to Response: The vast majority of document. The commenter contended enroll in Medicare because a clinical providers and suppliers providing that this would prove burdensome social worker is a type of provider or services in the MA program are already because new agreements would have to supplier eligible to enroll. Furthermore, enrolled in Medicare. Based on the be signed each time a provider or § 410.73(a) defines clinical social number of providers and suppliers supplier enters or departs a contractual worker and states they must have a needing to enroll to become compliant relationship with a PACE organization. masters or doctoral degree in social with this requirement, we do not The commenter recommended that CMS work, among other requirements. If the anticipate this impacting network (1) devise an alternative approach, or (2) clinical social worker cannot enroll adequacy and access to care. require PACE organizations to furnish because he or she fails to meet program PACE this information only on an annual requirements, such as this educational basis; concerning the latter, the Comment: A commenter asked requirement, he or she may not enroll in commenter said that this would not whether the requirements that are the program or provide services to absolve PACE organizations from applicable to FDR entities of MA beneficiaries enrolled in programs ensuring that all contracted providers organizations will also apply in the under this final rule, such as the PACE and suppliers, but would reduce the context of PACE organizations. program. It does not mean that reporting burden. Another commenter Response: The requirements for FDR providers and suppliers, that are of the shared these concerns and added that entities also apply to PACE type of providers or suppliers eligible to uninterrupted access to PACE services organizations. enroll in Medicare, are exempt from should be ensured. Comment: A commenter stated that enrolling because they cannot or do not Response: We understand the our proposals should not be applied to meet the necessary requirements for operational concerns and thank the the PACE program for several reasons. their specific provider or supplier type commenters. Based on this concern, we First, the proposed requirements are to enroll in Medicare. Providers and have reduced the burden this duplicative of exclusion screening supplier that cannot or do not meet the requirement would have imposed on requirements established by the OIG, enrollment requirements may not PACE organizations by aligning the which are often reinforced by state provide items and services to requirements to the provisions screening requirements. Second, PACE beneficiaries that receive items and applicable to MA organizations. We organizations are already Medicare- services through FFS, MA, MA–PD, have removed the requirement in 42 certified provider entities responsible PACE, and Cost plans, as well as CFR 460.32 and simply added §§ 460.70 for the comprehensive medical, health demonstration and pilot programs. We and 460.71. We believe this change will and social well-being of their PACE have decided to finalize the proposal to ensure that PACE organizations employ participants; existing regulations under include PACE organizations in this rule and contract with enrolled providers part 460 have requirements in place because we believe it is in the best and suppliers without the additional concerning these policies. The interest of the beneficiaries to receive burden of having the parties update the commenter stated that PACE is a items and services from Medicare program agreement. different model of care from MA providers and suppliers that are subject Comment: A commenter organizations. The latter are insurers to the same screening requirements. The recommended that any enrollment while PACE programs are Medicare- screening efforts mentioned by the regulatory requirements imposed on certified provider entities that are commenter are not duplicative to any PACE organizations be made in part 460 directly responsible for the care of other process, specifically OIG and state and that such requirements have the Medicare and Medicaid beneficiaries. At screening. We have access to same specificity and precision as the a minimum, the commenter stated, information and authority for keeping regulation changes proposed for part PACE organization personnel (for certain providers and suppliers out of 422. example, employees and contractors) the program that are not available to Response: We believe the appropriate should be exempt from the enrollment these entities. Additionally, while it requirements have been reflected in part requirement; the burden of requiring the may be true that PACE organizations are 460. enrollment of staff members, the Medicare-certified provider entities, the commenter contended would be individual providers and suppliers have Other Comments enormous. Another commenter not been required to enroll. We do not Comment: A number of commenters suggested that CMS clarify in the final anticipate that this rule will have a supported our proposal to require

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providers or suppliers who furnish several commenters suggested 4 years Response: We believe this request is health care items or services to an MA from the date of this rule. outside the scope of the rule. beneficiary be enrolled in Medicare in Response: We believe that the 2019 Comment: A commenter asked an approved status. A commenter stated implementation date is appropriate and whether CMS is collaborating with state that many MA organizations already takes into account the concerns raised Medicaid agencies to discuss have this requirement in place, and by the commenters. We thank the implementation issues related to a supported our efforts to standardize this comments for the suggestions regarding similar enrollment requirement on the practice across all organizations. operational planning and will take them Medicaid side; the commenter indicated Response: We appreciate the into consideration as we issue future that such discussions could assist CMS commenters’ support. guidance. in effectively implementing the MA Comment: A commenter disagreed Comment: A commenter contended enrollment requirement. with the use of the term ‘‘intermediary’’ that an increasing number of physician Response: On May 6, 2016, we being applied to MA organizations. The practices may provide most or all of published the ‘‘Medicaid and Children’s commenter stated that MA organizations their Medicare services to MA patients. Health Insurance Program (CHIP) are state licensed, risk-bearing entities The commenter encouraged CMS to Programs; Medicaid Managed Care, that contract with CMS to provide develop means by which such CHIP Delivered in Managed Care, and Medicare Part A, B, and D benefits and physicians can remain enrolled, for Revisions Related to Third Party services. An intermediary, the purposes of furnishing MA services, Liability’’ final rule (81 FR 27498) that commenter stated, is a Medicare without having to submit Part B claims. includes requirements for providers and Response: If the commenter is Administrative Contractor that bears no suppliers that provide services to concerned about possible deactivations Medicaid beneficiaries in a managed risk but is under contract with CMS to due to 12 consecutive months of non- care setting to be screened and enrolled pay Medicare covered claims and billing, we can say that although in Medicaid. We collaborate regularly perform other functions for CMS. The § 424.540(a)(1) is part of our regulatory with state Medicaid agencies when commenter sought greater clarification authority, its use is limited due to the operationalizing rules and appreciate on this issue. expansion of our enrollment the commenter’s suggestion. Response: We used intermediary as a requirements in Medicare that extend Comment: A commenter asked general term to describe an entity that beyond billing Parts A and B. We have whether the enrollment requirements holds a position between CMS and the thousands of providers and suppliers apply to providers that are participating provider and supplier communities; we enrolled in Medicare that do not submit in special CMS initiatives, such as did not mean ‘‘intermediary’’ as the claims for payment, such as providers Accountable Care Organizations former contractor entity that paid and suppliers ordering and certifying initiatives and, if not, why not, and Medicare claims in the past before there certain items and services and which entity in these initiatives would were MACs. As the public is likely prescribers of Part D drugs. Thus, be held accountable as to their aware, we do not pay providers and systematic deactivations for 12 participating providers and suppliers suppliers directly in the MA program. consecutive months of non-billing are enrolled in Medicare. The We appreciate the opportunity to would not be appropriate for providers commenter stated that it would be clarify. and suppliers that enrolled exclusively reasonable to have this requirement Comment: Several commenters for purposes unrelated to billing the extend beyond the MA and Part D requested that CMS delay the Medicare program. We are mindful of programs. implementation of the MA enrollment the scenario described as we Response: We believe this comment is requirement. They generally stated that operationalize this rule. outside the scope of this rule. a delay would give all stakeholders (for Comment: One commenter expressed example, MA organizations, providers, Scope support for requiring MA network suppliers, beneficiaries, and CMS) Comment: A commenter asked CMS providers to publicly report quality data adequate time to prepare for the to clarify the MA enrollment in a manner consistent with Part A and requirement. They added that the delay requirement’s relationship to the Part D B providers, specifically, requiring these would enable CMS to resolve certain prescriber enrollment rule and the providers to submit administrative data issues encountered in the Part D latter’s implementation date. sets to CMS such as claims and enrollment process so they are avoided Response: The Part D prescriber encounter data in a manner consistent in the MA enrollment process. Some enrollment requirement states that with Medicare Part A and B programs. commenters stated that CMS must nearly all prescribers of Part D drugs The commenter stated that there establish an implementation plan, must be enrolled in Medicare or validly currently is little insight as to the provide operational and technical opted-out. The requirement in this rule quality, volume, and utilization patterns guidance (including clarity around is that providers and suppliers that of beneficiaries who elected MA FDRs), and develop a comprehensive provide services to Medicare coverage. education and outreach strategy for beneficiaries in MA organizations or Response: We appreciate this relevant stakeholders, and that a delay MA–PD plans, including FDRs, must be comment but believe it is outside the would give CMS time to perform these enrolled in Medicare. These are separate scope of this rule. activities. Several commenters requirements; therefore, the Comment: One commenter, while recommended that the requirement be implementation date for the Part D supporting our proposed requirement, implemented at the same time as the prescriber rule is outside the scope of made two recommendations. The first Part D enrollment requirement, with one this rule. was that CMS should use the MA commenter specifically suggesting an Comment: A commenter asked CMS enrollment requirement as an effective date in CY 2020 for both to clarify the benefits of increased opportunity to begin deeming providers requirements. Other commenters opportunities for private practice for general compliance training as well. recommended an effective date for the physical therapists to become in- The second was that CMS should obtain MA enrollment requirement of least 3 network providers under MA the demographic data for providers at years from the date of this final rule; organizations. the point of enrollment into Medicare

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and require providers to supply CMS the various sections of this final rule We are finalizing the beneficiary with updates; plans would be expected under the corresponding heading. eligibility criteria and our referral policy to use the most up-to-date information Commenters ranged from professional as proposed. CMS has on file for providers when organizations, health plans, advocacy We are finalizing the proposed high updating the directories. This would groups, individual physicians, and screening level for MDPP supplier create a provider demographic numerous individuals who have direct enrollment, the requirement for coaches repository, which the commenter experience with the National Diabetes to obtain National Provider Identifiers believed would help ensure consistency Prevention Program (National DPP), and (NPIs), and for DPP organizations to between CMS and MA records. expressed overwhelming support for submit a roster of coach NPIs and other Response: We believe these comments this model expansion. Commenters coach information upon applying for are outside the scope of this rule. raised key considerations as well. enrollment. We are modifying our Comment: A commenter Because the MDPP expanded model proposal regarding the enrollment of recommended that CMS explain will be implemented through at least existing Medicare providers or whether providers and suppliers two rounds of rulemaking, we have suppliers, and are requiring all DPP participating in a section 1876 cost chosen in this final rule to finalize organizations, regardless of any existing contract plan, a section 1833 health care aspects of this model expansion that enrollment in Medicare, to enroll in prepayment plan, the Railroad will enable organizations to prepare for Medicare as MDPP suppliers in order to Retirement Board, or an Indirect enrollment. This includes finalizing the furnish and bill for MDPP services. Payment Procedure (IPP) entity that framework for expansion and finalizing We are not finalizing our proposal does not treat Medicare FFS details of the MDPP benefit, beneficiary that organizations that deliver DPP beneficiaries, are subject to the $500 eligibility criteria, and MDPP supplier virtually or through remote technologies will be eligible to furnish MDPP application fee. eligibility criteria and enrollment services to future rulemaking. We Response: We believe this comment is policies. intend to address policies related to the outside the scope of this final rule. We are finalizing our proposal to delivery of virtual MDPP services in expand the duration and scope of the J. Expansion of the Diabetes Prevention future rulemaking. We are also not Program (DPP) Model DPP model test as proposed. We are also finalizing the definition of preliminary finalizing our proposal to designate recognition. We intend to seek comment 1. Summary MDPP services as ‘‘additional on recognition standards in future This final rule finalizes our proposal preventive services’’ as defined by rulemaking. to expand the duration and scope of the section 1861(ddd) of the Act. We are We are also deferring certain policies, Diabetes Prevention Program (DPP) finalizing our proposal to use the specifically related to payment, use of model test, which we refer to as the Secretary’s waiver authority under coach information during enrollment Medicare Diabetes Prevention Program section 1115A(d)(1) of the Act to waive and monitoring, and other program (MDPP) expanded model.15 The MDPP two requirements of the benefit category integrity safeguards to future expanded model aims to prevent the of additional preventive services: the rulemaking. In particular, specific onset of type 2 diabetes among Medicare requirement in section 1861(ddd)(1)(B) policies regarding monitoring and beneficiaries diagnosed with pre- of the Act that the services be enforcement actions for supplier diabetes. Services available through the recommended by a grade of A or B from enrollment require future rulemaking. MDPP expanded model are MDPP the United States Preventive Services Because we are not implementing such services, which will be furnished in Task Force (USPSTF) and the requirements in this rule, we cannot community and health care settings by requirement of section 1861(ddd)(2) of begin any enrollment for organizations coaches, such as trained community the Act that the Secretary make the seeking to enroll as MDPP suppliers health workers or health professionals. determinations required under section until after the next round of rulemaking The MDPP expanded model is a Center 1861(ddd)(1) of the Act using the is complete in 2017. We intend to begin for Medicare and Medicaid Innovation National Coverage Determination (NCD) supplier enrollment before the model (Innovation Center) model that is being process. expansion becomes effective on January expanded in duration and scope under We are finalizing our proposal that 1, 2018. We intend for organizations to section 1115A(c) of the Act and will be the MDPP core benefit is 12 consecutive be able to apply to enroll as MDPP covered as an additional preventive months and consists of at least 16 suppliers at the conclusion of the next service under Medicare. weekly core sessions over months 1–6 round of rulemaking. We may issue We received approximately 700 and at least six monthly core subregulatory guidance to assist in this timely pieces of correspondence maintenance sessions over months 6– preparation before subsequent containing multiple comments on the 12, furnished regardless of weight loss. rulemaking is finalized. We will address MDPP expanded model. We note that Eligible beneficiaries will have access to public comments on sections of the some of these public comments were ongoing maintenance sessions after the proposed rule we sought comment on, outside of the scope of the proposed MDPP core benefit if they achieve and including payment, quality reporting, rule. Summaries of the public comments maintain the required minimum weight and program integrity, in future that are within the scope of the loss of five percent. We are adding rulemaking. proposed rule and our responses to definitions of ‘‘maintenance session The MDPP expanded model will those public comments are set forth in bundle’’ and ‘‘maintenance of weight become effective nationwide beginning loss’’ to help provide clarity. We are on January 1, 2018. We will continue to 15 Centers for Medicare & Medicaid Services, revising the definition of ‘‘CDC- evaluate this expanded model test. Proposed Rules, ‘‘Proposed Expansion of the approved core curriculum’’ to remove Diabetes Prevention Program (DPP) Model,’’ specific curriculum topic names. We are 2. Background Federal Register 81, no. 136 (July 15, 2016): 46413– also revising the session duration In January 2015, the Administration 46418, https://www.federalregister.gov/documents/ announced the vision of ‘‘Better Care, 2016/07/15/2016–16097/medicare-program- requirement to specify that any session revisions-to-payment-policies-under-the-physician- must have a duration of approximately Smarter Spending, Healthier People’’ fee-schedule-and-other-revisions. one hour. with emphases on improving the way

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providers are paid, improving and Fortunately, type 2 diabetes is Arizona, Delaware, Florida, Indiana, innovating in care delivery, and sharing typically preventable with appropriate Minnesota, New York, Ohio, and Texas. information to support better decisions, lifestyle changes. The National DPP, According to the second year and that set goals for payments made administered by the Centers for Disease independent evaluation report of the through alternative payment models and Control and Prevention (CDC), is an DPP model test, Medicare beneficiaries tied to quality or value. In March 2016, evidence-based intervention targeted to demonstrated high rates of participation the United States Department of Health individuals with pre-diabetes, meaning and sustained engagement in the and Human Services (HHS) announced those with blood sugar that is higher Diabetes Prevention Program. that an estimated 30 percent of than normal but not yet in the diabetes Approximately 83 percent of recruited Medicare payments are tied to range. The National DPP is a structured Medicare beneficiaries attended at least alternative payment models that reward health behavior change program four core sessions and approximately 63 the quality of care over quantity of delivered in community and health care percent completed nine or more core services provided to beneficiaries, settings by trained community health sessions. The first and second nearly a year ahead of schedule. workers or health professionals. The independent evaluation reports are Diabetes affects more than 25 percent National DPP consists of 16 intensive available on the Innovation Center’s of Americans aged 65 or older 16 and its core sessions of a CDC-approved Web site at https://innovation.cms.gov/ prevalence is projected to increase curriculum in a group-based setting that initiatives/Health-Care-Innovation- approximately 2 fold for all U.S. adults provides practical training in long-term Awards/. (ages 18–79) by 2050 if current trends dietary change, increased physical continue.17 Additionally, the risk of activity, and problem-solving strategies 3. Requirements for Expansion progression to type 2 diabetes in an for overcoming challenges to sustaining Section 1115A(c) of the Act provides individual with pre-diabetes is 5–10 weight loss and a healthy lifestyle. After the Secretary of the U.S. Department of percent per year, or 5–20 times higher the 16 core sessions, monthly Health and Human Services (the than in individuals with normal blood maintenance sessions help to ensure Secretary) with the authority to expand glucose.18 Care for Americans aged 65 that the participants maintain healthy (including implementation on a and older with diabetes accounts for behaviors. The primary goal of the nationwide basis) through rulemaking roughly $104 billion annually, and these intervention is to reduce incidence of the duration and scope of a model that costs are growing.19 In total, we estimate type 2 diabetes by achieving at least 5 is being tested under section 1115A(b) that Medicare will spend $42 billion percent average weight loss among of the Act if the following findings are more in the single year of 2016 on fee- participants. To learn more about the made, taking into account the for-service, non-dual eligible, over age National DPP, please visit http:// evaluation of the model under section 65 beneficiaries with diabetes than it www.cdc.gov/diabetes/prevention/ 1115A(b)(4) of the Act: (1) The Secretary would spend if those beneficiaries did lifestyle-program/index.html. determines that the model expansion is not have diabetes—$20 billion more for In 2012, the Innovation Center expected to either reduce spending Part A, $17 billion more for Part B, and awarded a Health Care Innovation without reducing quality of care or $5 billion more for Part D. On a per- Award (HCIA) to The Young Men’s improve the quality of patient care beneficiary basis, this disparity is just as Christian Association (YMCA) of the without increasing spending; (2) the clear. In 2016 alone, Medicare will USA (Y–USA) to test whether DPP CMS Chief Actuary certifies that the spend an estimated $1,500 more on Part services could be successfully furnished expansion would reduce (or would not D prescription drugs, $3,100 more for by non-physician, community-based result in any increase in) net program hospital and facility services, and organizations to Medicare beneficiaries spending; and (3) The Secretary $2,700 more in physician and other diagnosed with pre-diabetes and determines that the expansion would clinical services for those with diabetes therefore at high risk for development of not deny or limit the coverage or than those without diabetes.20 type 2 diabetes (referred to hereafter as provision of benefits. the DPP model test). The DPP model test • Improved Quality of Care without 16 Centers for Medicare & Medicaid Services, has been conducted under the authority Increased Spending: The DPP model ‘‘Chronic Conditions Among Medicare of section 1115A of the Act, which Beneficiaries, Chartbook: 2012 Edition,’’ Centers for test was designed to improve care Medicare & Medicaid Services, 2012, https:// authorizes the Innovation Center to test through diabetes-related preventive www.cms.gov/research-statistics-data-and-systems/ innovative health care payment and services in community- and primary- statistics-trends-and-reports/chronic-conditions/ service delivery models that have the care based settings. Weight loss is a key downloads/2012chartbook.pdf. potential to reduce Medicare, Medicaid, indicator of success among persons 17 James Boyle, et al., ‘‘Projection of the Year 2050 and Children’s Health Insurance Burden of Diabetes in the US Adult Population: enrolled in a DPP due to the strong Dynamic Modeling of Incidence, Mortality, and Pre- Program (CHIP) expenditures while association between weight loss and Diabetes Prevalence,’’ Population Health Metrics 8, preserving or enhancing the quality of reduction in the risk of diabetes.21 no. 29 (2010): 1–12. patient care. According to the second year 18 X Zhang et al., ‘‘A1C Level and Future Risk of Between February 2013 and June independent evaluation of the DPP Diabetes: A Systematic Review,’’ Diabetes Care 33, 2015, the Y–USA, in partnership with no. 7 (2010): 1665–1673. model test, those beneficiaries who 17 local YMCAs, the Diabetes 19 James Boyle, et al., ‘‘Projection of the Year 2050 attended at least one core session lost an Burden of Diabetes in the US Adult Population: Prevention and Control Alliance, and average of 7.6 pounds while Dynamic Modeling of Incidence, Mortality, and Pre- seven other non-profit organizations, beneficiaries who attended at least four Diabetes Prevalence,’’ Population Health Metrics 8, enrolled a total of 7,804 Medicare core sessions lost an average of 9 no. 29 (2010): 1–12. beneficiaries into the model. Enrolled 20 pounds. Body Mass Index (BMI) was Erkan Erdem and Holly Korda, ‘‘Medicare Fee- beneficiaries represented a diverse For-Service Spending for Diabetes: Examining reduced from 32.9 to 31.5 among Aging and Comorbidities,’’ Diabetes & Metabolism demographic across the eight states of Medicare beneficiaries that attended at 5, no. 3 (2014); The Boards of Trustees: Federal least four core sessions. The evaluation Hospital Insurance and Federal Supplementary Medicare & Medicaid Services, 2016, https:// Medical Insurance Trust Funds, ‘‘2016 Annual www.cms.gov/Research-Statistics-Data-and- Report of the Boards of Trustees of the Federal Systems/Statistics-Trends-and-Reports/ 21 RF Hamman et al., ‘‘Effects of Weight Loss with Hospital Insurance and Federal Supplementary ReportsTrustFunds/downloads/tr2016.pdf.; and Lifestyle Intervention on Risk of Diabetes,’’ Diabetes Medical Insurance Trust Funds,’’ Centers for CMS estimates. Care 29, no. 9 (2006): 2102–2107.

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also demonstrated a statistically Commenters also encouraged us to informing the MDPP expansion are significant reduction in inpatient continue to align with the CDC Diabetes unique to this particular model. For admissions following the intervention. Prevention Recognition Program example, different approaches to Based on these findings and results from Standards and Operating Procedures actuarial modeling may be required for other DPP evaluations demonstrating (CDC DPRP Standards) on various a preventive service payment and the effectiveness of DPP programs in policies such as supplier requirements, service delivery model as compared to preventing diabetes onset in non- recognition status, and required a payment model focused on treatment. Medicare beneficiaries, some of which minimum weight loss percentage. We expect to take into account the were over 65, the Secretary determined Another commenter recommended that specific aspects of each model when that expansion of the DPP model test is we reimburse for technology such as the evaluating it for expansion. We found expected to improve the quality of continuous glucose monitor. Some that the DPP model test has been shown patient care for Medicare beneficiaries commenters encouraged us to continue to reduce risk of type 2 diabetes through without increasing spending. to take steps toward more preventive weight loss and behavior change. The • Impact on Medicare Spending: The models. One commenter disagreed second year independent evaluation of CMS Chief Actuary (referred to hereafter altogether with the proposed MDPP the DPP model test also found as the Chief Actuary) has certified that model expansion, stating it allows statistically significant reductions in expansion of the DPP model test would another high risk supplier type into the inpatient and emergency room visits not result in an increase in Medicare Medicare program. and robust engagement by beneficiaries. spending. The Chief Actuary has Response: We appreciate the Expansion of the DPP model test will determined that DPP is likely to reduce commenters’ suggestions to increase give eligible beneficiaries access to Medicare expenditures if made available beneficiary awareness of the benefit, MDPP services, which are evidence- to eligible Medicare beneficiaries based and look forward to exploring ways we based, to improve their health. The on historical evidence from evaluations can achieve our shared aims through Secretary has determined that by of the DPP model test and other DPPs. stakeholder engagement and improving health outcomes, as In addition, to evaluate the longer-term communications efforts, such as updates measured by participation in the DPP impact of the expanded model, the to the Medicare & You Handbook. We and weight loss, the MDPP expanded Chief Actuary developed a model to also hope to engage the public and model will improve beneficiaries’ estimate lifetime per participant savings MDPP stakeholders in further quality of care. Weight loss is a key of a Medicare beneficiary receiving DPP developments and any adjustments we indicator of success among persons services. make through future rulemaking, enrolled in the DPP as it predicts the The full Chief Actuary Certification is subregulatory guidance, or other reduced incidence of type 2 diabetes.22 available at https://www.cms.gov/ guidance, as appropriate. We appreciate According to the second year Research-Statistics-Data-and-Systems/ the comments to test more preventive independent evaluation of the DPP Research/ActuarialStudies/Downloads/ models and to pay for technology that model test, which included 6,874 Diabetes-Prevention-Certification-2016- could be used in connection with the Medicare beneficiaries, those 03-14.pdf. MDPP expanded model, but those are beneficiaries who attended at least one • No Alteration in Coverage or outside the scope of what we proposed core session lost an average of 7.6 Provision of Benefits: The MDPP model to expand, and we decline to include pounds while beneficiaries who expansion would make MDPP services them in the MDPP model expansion. We attended at least four core sessions lost available to beneficiaries in addition to disagree with the commenter who an average of nine pounds. BMI was existing Medicare services, and believed we should not expand the DPP reduced from 32.9 to 31.5 among beneficiaries receiving MDPP services model test. We describe later in this rule Medicare beneficiaries that attended at would retain all benefits covered in some of the enrollment policies that are least four core sessions. traditional Medicare. Therefore, the intended to protect against the risks Comment: Regarding the Chief Secretary has determined that introduced by the new supplier class. Actuary’s certification, some expansion of the DPP model test would Additionally, we intend to propose commenters expressed appreciation that not deny or limit the coverage or specific program integrity policies in the determination was made available to provision of Medicare benefits for future rulemaking. the public several months before the Medicare beneficiaries. Comment: A few commenters proposed rule. One commenter also The following is a summary of the expressed concerns that the MDPP asked us to clarify if, and how, comments received and our responses. model expansion will set a flawed stakeholders can engage with the Comment: Commenters were precedent for future model expansions. certification process in the event that overwhelmingly in favor of the For example, two commenters there are outstanding questions of proposed expansion and Medicare expressed concerns that the Secretary’s methodology and model assumptions. covering the MDPP services as an determination that the MDPP model Two commenters criticized the Chief additional preventive service. Many expansion would improve the quality of Actuary’s consideration of findings in commenters offered personal stories of care is not substantiated by the addition to the DPP model test, such as their battles with type 2 diabetes, or evidence, and asked for more discussion other DPPs in the National DPP, in caring for those with type 2 diabetes, of how the MDPP expansion will making the certification. A commenter and expressed gratitude toward the improve other elements within quality stated that the Chief Actuary certified agency for proposing to cover the of care, such as patient experience. the expansion of a model that is Response: We are undertaking the benefit to prevent future beneficiaries different than the tested model, which MDPP model expansion in a manner from the challenges posed by type 2 the commenter viewed as contrary to consistent with the statutory diabetes. Commenters encouraged us to the statute. MedPAC expressed concern requirements of section 1115A(c) of the consider ways to increase beneficiary that the MDPP expanded model would awareness and lower barriers to access. Act. Therefore we do not agree that Several commenters expressed their expansion of the DPP model test sets a 22 RF Hamman et al., ‘‘Effects of Weight Loss with desire to assist us in further flawed precedent. We also note that the Lifestyle Intervention on Risk of Diabetes,’’ Diabetes development of the model expansion. specific data, analyses, and other factors Care 29, no. 9 (2006): 2102–2107.

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expand far beyond the structure of the duration or scope. For example, a used to monitor whether beneficiaries initial model test. One commenter nationwide expansion may require are receiving the services that would be expressed concern that this different policies and operations to expected given beneficiaries’ health determination was made based on a manage large-scale provider enrollment status. The comparison group generally preliminary, 2-year evaluation. or payment than does the initial model consists of beneficiaries who are similar Response: We appreciate commenters’ test. The Chief Actuary certified to the beneficiaries receiving services interest in the certification process. The expansion of the DPP model test under the model, and are often matched CMS Office of the Actuary, led by the understanding that the expansion would on underlying health status and other Chief Actuary, functions in accordance include specific changes driven by important characteristics, including with professional standards of actuarial policies and operations necessary in whether the beneficiary is part of independence. The statute does not bringing the model to a national scale. another model test. We intend to apply require that in certifying an expansion As the expansion’s full design is additional information on the the Chief Actuary may consider data implemented in future rulemaking, the evaluation in the future. We will only from the model evaluation; rather, Chief Actuary will assess whether such continue to assess whether the MDPP the statute requires only that the expansion will reduce or not increase expanded model is expected to improve evaluation be taken into consideration. net program spending, and will update the quality of care without increasing The Chief Actuary also reviewed data the certification as appropriate. spending, reduce spending without from other sources besides the model Comment: Some commenters reducing the quality of care, or improve evaluations in certifying the Pioneer supported the determination that the the quality of care and reduce spending, Accountable Care Organization (ACO) DPP model expansion would not deny and we will terminate or modify the Model, the first Innovation Center or limit the coverage or provision of MDPP expanded model if the expanded model determined eligible for Medicare benefits for Medicare model is not expected to meet these expansion. In April 2015, the Chief beneficiaries as the MDPP expanded criteria. Actuary certified that expansion of the model makes additional services Pioneer ACO Model, as it was tested in available to eligible beneficiaries. Two 4. Expansion of the Diabetes Prevention the model’s first 2 years, would reduce commenters asked that in future model Program Model net program spending. The Chief expansions we assess the impact of a We proposed to expand the duration Actuary used historical evidence from model on patient access to covered and scope of the DPP model test under the formal evaluation of the Pioneer items and services based on a broad section 1115A(c) of the Act, and we ACO Model as well as the Chief evaluation of the direct and indirect proposed to refer to this expanded Actuary’s independent internal analysis barriers to care that may result from a model as the MDPP. In this section of of financial impacts. The Chief model’s expansion. this final rule, we are finalizing a Actuary’s certification of the Pioneer Response: We appreciate the framework for the MDPP expanded ACO Model is available at https:// commenters’ support regarding the model. We intend to engage in www.cms.gov/Research-Statistics-Data- determination that the expansion of the additional rulemaking in 2017, to and-Systems/Research/ DPP model test would not deny or limit establish additional requirements of the ActuarialStudies/Downloads/Pioneer- the coverage or provision of Medicare MDPP expanded model. We solicited Certification-2015-04-10.pdf. The benefits. We will apply the statutory comment on all of the proposals below Secretary also determined that criteria for expanding a model on an and on other policy or operational expansion would not limit coverage or individual basis and will take the issues that need to be considered in benefits, and that expansion would particular features of each model into implementing this expansion. maintain or improve patient care account when making any a. Designation of MDPP Services as without increasing spending. While the determinations. Additional Preventive Services Under Pioneer ACO Model has not been Comment: Several commenters Section 1861(ddd) of the Act expanded through section 1115A(c) of encouraged us to continue to collect the Act, CMS has incorporated data and evaluate the impact of the We proposed to designate MDPP successful design elements of the expanded model test. services as ‘‘additional preventive Pioneer ACO Model into the Medicare Response: We will continue to services’’ available under Medicare Part Shared Savings Program. evaluate this expanded model test as B. Section 1861(ddd) of the Act defines The statute does not require that an indicated in the proposed rule. Using an ‘‘additional preventive services’’ as expanded model test be identical to the evaluation design that could include a services (other than screening or other initial model test. Indeed, section before and after assessment and or preventive services or personalized 1115A(c) of the Act authorizes the matched comparison groups, we will prevention plan services described in Secretary to expand (including examine the impact of the model on other sections of the Act) that identify implementation on a nationwide basis) utilization of services and cost of care, medical conditions or risk factors, and the duration and the scope of a model particularly whether the model has had that the Secretary determines, using the being tested under subsection (b) or a an impact on the development of National Coverage Determination (NCD) demonstration project under section diabetes, and other health consequences process, are (A) reasonable and 1866C of the Act through rulemaking. of diabetes. We will also examine the necessary for the prevention or early The rulemaking requirement indicates expanded model’s impact on changes in detection of an illness or disability; (B) that the expansion is to be subject to health metrics, such as weight loss. recommended with a grade of A or B by public comment, which, in turn, In general, evaluations of Innovation the United States Preventive Services indicates that the expansion can and Center models address the impact of the Task Force (USPSTF); and (C) should be modified as appropriate to models on use of services and the appropriate for individuals entitled to reflect the outcome of the rulemaking quality of care provided, relative to a benefits under Part A or enrolled in Part process. In addition, we expect that we comparison group, using CMS B. will need to modify some design administrative data and relevant We believe that MDPP services are features in nearly all cases of expanded beneficiary experience data when consistent with the types of additional model tests, by virtue of the shift in available. Utilization measures can be preventive services that are appropriate

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for Medicare beneficiaries. In particular, Response: We disagree with the differences make USPSTF’s we believe that MDPP services meet the commenters. Section 1115A(d)(1) of the recommendation inapplicable to MDPP, requirements of section 1861(ddd)(1)(A) Act authorizes the Secretary to waive and therefore the waiver is necessary. of the Act (that is, that they are certain requirements as may be In particular, the specific USPSTF reasonable and necessary for the necessary solely for purposes of carrying recommendation cited by commenters is prevention or early detection of an out this section with respect to testing for ‘‘adults aged 40 to 70 years who are illness or disability) because they are models described in subsection (b). We overweight or obese who are seen in specifically designed to prevent pre- believe that the phrase ‘‘described in primary care settings,’’ which does not diabetes from advancing into type 2 subsection (b)’’ is simply a reference include Medicare beneficiaries over 70 diabetes and their effectiveness is that describes the models that are who would be eligible for MDPP supported by the evaluations of the DPP authorized under subsection (b), and services or the furnishing of MDPP model test. that the waiver authority extends to services by a community service We proposed to use the Secretary’s expanded models because they continue organization. waiver authority under section to be models described in subsection While the USPSTF recommendation 1115A(d)(1) of the Act to waive two (b). The language of section 1115A(c) of discussed by the commenters does not requirements of the benefit category of the Act itself supports this view because match with the elements of the MDPP additional preventive services. MDPP it gives the Secretary authority to model expansion, we do note that the services do not meet the requirement in expand the duration and scope of a recommendation supports the principle section 1861(ddd)(1)(B) of the Act in model that is being tested under of the MDPP expanded model. In that MDPP services have not been subsection (b). addition, we have spoken to the recommended with a grade of A or B by Therefore, in our view, the Secretary USPSTF about its recommendation and the USPSTF, and thus a waiver of that is authorized to waive requirements of shared the findings of the evaluation of requirement is necessary. We proposed Title XI, Title XVIII, and sections the model in case the USPSTF would to use the Secretary’s waiver authority 1902(a)(1), 1902(a)(13), like to reconsider its recommendation. 1902(m)(2)(A)(iii), and 1934 of the Act to waive this requirement with respect Similarly, we note that in 2014, the (other than subsections (b)(1)(A) and to MDPP services. Community Preventive Services Task (c)(5) of such section) in connection We proposed to waive the Force (CPSTF), a ‘‘sister entity’’ to the with expanded model tests. As the requirement of section 1861(ddd)(2) of USPSTF that is focused on population- MDPP model expansion is an expansion the Act that the Secretary make the based interventions, issued a of the duration and scope of a model determinations required under section recommendation for Diabetes: described in and tested under 1861(ddd)(1) of the Act using the NCD Combined Diet and Physical Activity subsection (b), the Secretary may waive process. We proposed to waive this Promotion Programs to Prevent Type 2 Medicare requirements as necessary for requirement because applying the NCD Diabetes Among People at Increased the purposes of the expanded model. process to the MDPP model expansion Comment: Many commenters believed Risk, specifically recommending is inappropriate, and thus the waiver is that the Secretary’s waiver of section ‘‘combined diet and physical activity necessary. The creation of a new 1861(ddd)(1)(B) of the Act, which promotion programs for people at supplier class is necessary for coaches requires that a benefit must be increased risk of type 2 diabetes based to furnish MDPP services, which the recommended with a grade of A or B by on strong evidence of effectiveness in NCD process was not designed to the USPSTF, is unnecessary. These reducing new-onset diabetes.’’ The address. commenters stated that the USPSTF CPSTF recommendation is available at Since Medicare cost-sharing does not issued guidance in October 2015 https://www.thecommunityguide.org/ apply to additional preventive services, entitled Abnormal Blood Glucose and findings/diabetes-combined-diet-and- MDPP services would not be subject to Type 2 Diabetes Mellitus: Screening, physical-activity-promotion-programs- Medicare cost-sharing. which provided a B rating for intensive prevent-type-2-diabetes. We believe that We solicited comment on these behavioral counseling interventions for the MDPP expanded model is consistent proposals. patients with abnormal blood glucose with the CPSTF recommendation. The following is a summary of the based on National DPP clinical trial Comment: One commenter suggested comments we received on designating evidence. This recommendation is that the Secretary should not waive the MDPP services as additional preventive available at https:// National Coverage Determination (NCD) services and our responses. www.uspreventiveservicestaskforce.org/ process required by section Comment: While some commenters Page/Document/ 1861(ddd)(2) of the Act. One commenter supported the Secretary’s use of the RecommendationStatementFinal/ suggested that it is irrelevant that the waiver authority provided by section screening-for-abnormal-blood-glucose- NCD process does not address the 1115A(d)(1) of the Act in expansion of and-type-2-diabetes. Because of this creation of a new supplier class. This the DPP model test, a few commenters recommendation, these commenters commenter also suggested that the stated that the statute does not permit suggested, the Secretary does not need statute does not require CMS to the Secretary to waive statutory or to waive the requirement in section implement an additional preventive regulatory requirements when a model 1861(ddd)(1)(B) of the Act. service via the NCD process; all it is expanded under section 1115A(c) of Response: While the interventions requires is that CMS make the three the Act. These commenters stated that mentioned in the USPSTF’s determinations that are prerequisites for any use of waiver authority in an recommendation bears some similarity additional preventive service status expanded model is not made ‘‘with to the expanded DPP model test, and using the NCD process. This commenter respect to testing models described in provides evidence to support DPPs also stated that the timing of the NCD subsection (b).’’ As a consequence, these generally, there are differences between process will not hinder this expansion, commenters stated, the Secretary lacks the USPSTF’s recommendation and the suggesting that we have the discretion to the authority to waive the provisions of design of the MDPP expanded model, expedite the NCD process. Another section 1861(ddd) of the Act proposed both as initially tested and as we have commenter suggested that waiving the in the proposed rule. proposed to expand it. We believe these NCD process is unnecessary because the

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creation of a supplier class is not cost sharing for MDPP services. A few used to determine the details of a hindered by the NCD process. commenters asked us to clarify that phased-in approach. Response: We disagree that waiving beneficiaries would not have to pay Response: We believe that nationwide requirements of section 1861(ddd)(2) of cost-sharing, particularly because they expansion of the scope of the model the Act is unnecessary. In particular, we were concerned that cost sharing would would allow the greatest access to the disagree with the commenters who restrict beneficiary access. MDPP services for beneficiaries. We also believe that using the NCD process Response: MDPP services are acknowledge the concerns that the would not create timing challenges for additional preventive services under MDPP expanded model introduces a the MDPP expanded model. To the section 1861(ddd) of the Act and new service and a new supplier type to contrary, we believe that the use of the therefore, consistent with section the Medicare program, and we will NCD process is inappropriate for the 1833(a)(1)(W) of the Act, are not subject prioritize beneficiary safety and the MDPP expanded model. to the Medicare Part B coinsurance or need to consider program integrity The MDPP expanded model deductible. concerns in our implementation of this necessitates the creation of a new Final Decision: We finalize our expansion. supplier class that must be able to enroll proposal to expand the duration and MDPP services will be available to eligible beneficiaries beginning on in Medicare so that it may furnish scope of the DPP model test as MDPP services as of the effective date of January 1, 2018, subject to additional proposed. We finalize our proposal to the expanded model. We are rulemaking on issues such as payment designate this benefit as an additional establishing the new supplier class for the service. However, as a factual preventive service according to section through rulemaking, in conjunction matter, eligible beneficiaries’ access to 1861(ddd) of the Act as proposed, and with the model expansion. Contrary to MDPP services will increase over time we also finalize our proposals to waive commenters’ assertions, using the NCD as more organizations seek and receive the requirements of sections process to designate MDPP services as CDC DPRP recognition, enroll in 1861(ddd)(1)(B) and (ddd)(2) of the Act additional preventive services would Medicare as MDPP suppliers, and as proposed. create significant timing challenges, therefore furnish MDPP services. As of given that we need to expand the model b. Timing of the Expansion of the October 2016, more than 1,000 and establish the MDPP supplier class Medicare Diabetes Prevention Program organizations have pending or full through rulemaking. If we were to use Model recognition from the CDC DPRP to the NCD process to determine that provide DPP services. As described in MDPP services are additional preventive We proposed that the expansion of section III.J.7.a. of this final rule, these services, we would not be able to begin the duration and scope of the DPP organizations will have to meet certain covering MDPP services on the date the model test would become effective on a standards before becoming eligible to NCD was issued, even if it were issued nationwide basis beginning on January enroll as a Medicare supplier. This will simultaneously with the effective date 1, 2018. Expanding the DPP model test provide a de facto phase in that will of a final rule establishing the supplier is a complex undertaking, which could allow us to gain experience with the class. This is because in order to align be approached in different ways, such MDPP expanded model with fewer the effective dates, we would have had as expanding the scope of the DPP organizations initially who meet the to issue a final rule establishing the model test nationally in its first year of supplier eligibility criteria, and more MDPP supplier class 60 days before we implementation or expanding the over time as supplier enrollment determined that MDPP services were duration and scope using a phase-in increases. covered by Medicare. Were we to approach. The phase-in approach could c. Other Comments on the Expansion of instead issue an NCD simultaneously expand MDPP initially for a period of the Medicare Diabetes Prevention with the release of a final rule time in certain geographic markets or Program Model establishing a new supplier class, the regions or among a subpopulation of benefit would be unavailable for a MDPP suppliers, with the goal of Comment: A few commenters period of time after the NCD’s effective addressing technical issues prior to expressed concern that MDPP suppliers date because of the 60-day delay in broader expansion. We solicited should be coordinating with primary effectiveness of the final rule plus time comment on whether to expand the care providers or other physicians, and needed thereafter to process MDPP scope of the DPP model test nationally a few commenters did not support the supplier enrollment applications. or use a phase-in approach, and if MDPP expanded model because they Because we cannot allow MDPP phased-in, what factors we should believed it would further fragment the suppliers to enroll specifically to consider in the possible selection of health care system. provide a service that is not yet a initial phased-in MDPP suppliers. Response: We appreciate and respect Medicare service, we find that it is Comment: We received many the concern regarding coordination with necessary for purposes of expanding the comments related to the timing of the the clinical care system, and we MDPP model to waive the requirements MDPP expansion. Commenters encourage MDPP suppliers to promptly of section 1861(ddd)(2) of the Act. This overwhelmingly supported nationwide communicate with the beneficiary’s rulemaking establishes MDPP services expansion of the DPP model test on health care providers as appropriate as additional preventive services that January 1, 2018, over a phase-in with the beneficiary’s consent to will become available after there is approach. Several commenters, promote care coordination. We also sufficient time to enroll MDPP suppliers including MedPAC, supported a phase- expect that some clinicians will furnish to furnish those services, which allows in approach, to allow CMS to address MDPP services on behalf of us to avoid timing and logistics program integrity issues before organizations that have or will obtain problems while also providing the nationwide expansion. Some CDC DPRP recognition and enroll in public with the opportunity to comment commenters made suggestions for where Medicare as MDPP suppliers. However, in a manner similar to the NCD process. and with which providers to phase the we did not propose specific rules or Comment: Commenters benefit in if CMS were to adopt the requirements around coordination with overwhelmingly supported the proposal phase-in approach. Others asked for primary care providers or other health to not hold beneficiaries responsible for clarification on what criteria would be care entities for the purposes of this

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MDPP expanded model because the DPP suggested using the name National We proposed that ongoing maintenance model test did not require this level of Diabetes Prevention Program (National sessions adhere to the same curriculum coordination. We also want to provide DPP), rather than MDPP, citing requirements as the core maintenance organizations with the flexibility they confusion in the market of payers that sessions. need to effectively coordinate care with currently cover DPP for their members. We solicited comment on these physicians while decreasing the Response: We believe prevention of proposals. administrative burden of offering the type 2 diabetes is the goal of the MDPP The following is a summary of the services. We will take these comments expanded model even though some comments received and our responses. into consideration as we finalize various beneficiaries may still be diagnosed Comment: Several commenters aspects of MDPP in future rulemaking. with type 2 diabetes, so we decline to suggested that we clarify whether MDPP Comment: One commenter suggested change the name to reference a ‘‘delay’’ suppliers must furnish MDPP services the use of mobile application-based in diabetes onset. We also believe MDPP in the second 6 months of the core technology with built in incentives for is the appropriate name for this benefit (the core maintenance sessions) beneficiaries. expanded model because there are or Medicare payment for services Response: We appreciate the differences between MDPP and the furnished in the second 6 months of the suggestion and we will consider it as we National DPP, such as the age of the core benefit without achievement of the engage in future rulemaking. beneficiaries served, beneficiary required 5 percent weight loss. The Comment: A few commenters eligibility criteria, and the DPP commenters recommended that we recommended they be allowed to apply organization or MDPP supplier allow MDPP suppliers to document and Diabetes Self-Management Training eligibility criteria. bill for achievement of beneficiary (DSMT) to beneficiaries with pre- weight loss at any time during the first diabetes. One commenter suggested that 5. MDPP Benefit Description year, rather than during only the first 6 CMS merge DSMT and MDPP because We proposed the MDPP core benefit months. One commenter suggested that core training elements are identical. to be 12-months of sessions using a CMS clarify if there is a minimum or Response: While we acknowledge that CDC-approved DPP curriculum, maximum number of beneficiaries that there may be similarities between the consisting of at least 16 core sessions an MDPP supplier must/may serve. two benefits, DSMT and MDPP have furnished over a range of 16 to 26 weeks Response: We clarify that core different eligibility criteria and goals. (that is, the first 6 months) and at least maintenance sessions in the second 6 Beneficiaries with a type 2 diabetes 6 monthly core maintenance sessions months are furnished as part of the 12- diagnosis have different needs than over weeks 27–52 (second 6 months). month core benefit, regardless of weight those with pre-diabetes. We therefore do We proposed that beneficiaries who loss. We refer readers to section III.J.7.b. not believe we should merge these complete the 12-month core benefit, and of this final rule for discussion of the benefits. achieve and maintain a required requirement that organizations maintain Comment: Several commenters minimum weight loss of 5 percent from CDC DPRP recognition to enroll in recommended that we add MDPP the first core session, in accordance Medicare to bill for furnishing MDPP services to the personalized prevention with the CDC Diabetes Prevention services. The CDC DPRP Standards plan offered as part of the Medicare Recognition Program Standards and require that DPP-eligible individuals be Annual Wellness Visit (AWV). A few Operating Procedures (CDC DPRP able to access the core maintenance commenters expressed disagreement Standards), would be eligible for sessions, regardless of weight loss, in with the focus on weight loss, citing monthly ongoing maintenance sessions order for an organization to maintain fitness and physical activity, metabolic for as long as the weight loss is CDC DPRP recognition. Therefore, we and behavioral markers, and other maintained. The CDC DPRP Standards are finalizing our proposal that the alternatives that CMS should consider are available at http://www.cdc.gov/ MDPP core benefit is a 12-month as outcomes for value-based payments. diabetes/prevention/pdf/dprp- program that consists of at least 16 Response: We did not test the other standards.pdf. We proposed to require weekly core sessions, over months 1–6, indicators that commenters each MDPP core and maintenance and at least 6 monthly core maintenance recommended such as fitness, metabolic session (both core and ongoing) be at sessions over months 6–12, furnished activity and behavioral markers. We will least one hour in duration. We proposed regardless of weight loss. We are making make adjustments through rulemaking, that the MDPP expanded model will use corresponding changes to the as necessary, if through our continuing the CDC-approved curriculum. Details regulations text to address when the evaluation we find that such pertaining to the content of both the MDPP core benefit will be available. We adjustments are warranted. One of the core sessions and maintenance sessions, intend to address payment for MDPP elements of the AWV is for the health as set by the CDC, are available at http:// services in future rulemaking. We will professional to furnish personalized www.cdc.gov/diabetes/prevention/pdf/ not require a minimum or maximum health advice to the beneficiary, and a curriculum_toc.pdf. number of beneficiaries at this time, referral, as appropriate, to health We proposed that during the first 6 recognizing that MDPP suppliers will education or preventive counseling months (weeks 1–26) of the MDPP core vary in capacity and mode of delivery. services or programs. An eligible benefit, each of the 16 core sessions However, we will monitor for signs of beneficiary can be referred for MDPP must address a different curriculum adverse selection of beneficiaries and services as part of a personalized topic included on the list of 16 propose specific program integrity prevention plan. We reiterate, however, curriculum topics, ensuring all topics requirements in future rulemaking, as that we did not propose to require that are addressed by the end of the 16 appropriate. beneficiaries obtain a referral for MDPP sessions. We proposed that the second Comment: Numerous commenters services, though as discussed in section 6 months (weeks 27–52) of the MDPP expressed general support for ongoing III.J.7.c. of this final rule, referrals are core benefit must include at least one maintenance sessions after the 12- permitted. core maintenance session furnished in month core benefit and recommended Comment: Some commenters each of the 6 months (for a minimum of that CMS allow beneficiaries access to suggested using the term ‘‘delay’’ rather six sessions), and all core maintenance ongoing maintenance sessions if they than ‘‘prevent’’ diabetes, and others sessions must address different topics. achieve the required 5 percent weight

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loss any time during the 12-month core to socioeconomic or demographic required 5 percent weight loss. The benefit. A few commenters factors. Another recommendation was to requirement that eligible beneficiaries recommended that CMS clarify the allow participants within 2 percentage must maintain 5 percent weight loss is definition of maintenance of weight points of the minimum weight loss to consistent with the weight loss goal loss, noting that it is common for have their maintenance sessions tested in the DPP model test, and was individuals to lose, regain, and lose covered to account for weight gain factored into the Secretary’s weight again. One commenter during extenuating circumstances (for determination to expand the model and recommended that beneficiaries whose example, falling ill or other the Chief Actuary’s certification that weight increases during the circumstances that interfere with weight MDPP expansion would not result in an maintenance period should have up to loss). increase of Medicare spending. We are 3 months to bring their weight back to Several commenters recommended not changing the requirement that the maintenance level. Another that access to ongoing maintenance beneficiaries must maintain the 5 commenter requested clarification on sessions, and payments for maintenance percent minimum weight loss in order when and how MDPP suppliers should session attendance, depend not on the 5 to receive ongoing maintenance track weight on an ongoing basis to percent weight loss, but instead on sessions. We acknowledge commenters’ ensure a beneficiary qualifies for attendance of monthly maintenance concerns regarding potential maintenance sessions, and whether sessions. Other commenters suggested unintended consequences if the MDPP beneficiaries should be weighed every that payment should be linked to expanded model results in low-income month to qualify. alternative measures rather than weight or other disadvantaged populations Several commenters recommended loss, such as A1C, waist measurement, having less access to ongoing allowing beneficiaries who did not and knowledge tests. maintenance sessions. We may consider achieve and maintain the required 5 Response: As noted previously, MDPP making adjustments as appropriate if, percent weight loss to still be able to eligible beneficiaries are eligible to through our monitoring and evaluation access the ongoing maintenance access core maintenance sessions in the and through tribal consultation, we find sessions. The commenters stated various second 6 months of the 12-month core that such adjustments are warranted to reasons, including that weight loss of benefit regardless of weight loss. MDPP address disparities in access. less than 5 percent is clinically relevant eligible beneficiaries are eligible to We disagree with a commenter’s and also reduces type 2 diabetes risk; access ongoing maintenance sessions suggestion that we use an aggregate, not the evidence base suggests greater after the 12 month core benefit if the impact on onset of diabetes through re- beneficiary achieves and maintains the individual, 5 percent weight loss for enrolling beneficiaries who are required minimum weight loss ongoing maintenance session eligibility. regaining weight than through percentage. We understand that We do not believe aggregate weight loss continuing the service for those who can beneficiaries’ weight may fluctuate after is an appropriate application for maintain weight loss; weight regain is meeting the 5 percent required weight individuals’ eligibility for ongoing common due to metabolic adaptation or loss. We are defining maintenance of maintenance sessions. We believe it is receding behavior changes; weight loss, which allows a beneficiary unfair to deny a beneficiary access to discontinuing the service for to access ongoing maintenance sessions, ongoing maintenance sessions if the beneficiaries who do not lose weight as achieving the required minimum beneficiary achieves 5 percent or more will discourage them and increase their weight loss from baseline weight at any weight loss but happens to attend MDPP risk for diabetes; the opportunity to point during each 3 months of core sessions with other beneficiaries who provide a safe environment of recovery maintenance or ongoing maintenance gain or do not lose the minimum for individuals who have a binge-eating sessions. In other words, a beneficiary weight. Aggregate weight loss can be disorder; and that the intervention will can access the next three months of arbitrary because there is no minimum still reduce diabetes among beneficiaries ongoing maintenance sessions if the or maximum number of beneficiaries who are unable to achieve or maintain beneficiary achieved maintenance of per MDPP supplier, and there is no way weight loss. Additionally, commenters weight loss at any point during the to ensure equal access to the benefit. It stated that exclusion from maintenance previous three months of maintenance decreases a beneficiary’s incentive to sessions for beneficiaries who do not sessions. As mentioned in comments, 3 meet the weight loss goal in order to achieve the required weight loss would months is the appropriate interval access ongoing maintenance sessions be punitive, particularly for because it aligns with the proposed and a suppliers’ incentive to actively beneficiaries who need the additional payment structure that pays for each help each beneficiary to meet that support to achieve the desired weight three maintenance sessions attended weight loss goal, particularly if a few loss goal. Some commenters suggested with maintenance of weight loss. A people lost a large percent of their that MDPP expanded model risks beneficiary’s weight must be measured weight. The goal of the DPP model test perpetuating health inequities because and recorded during every core session is at least 5 percent weight loss for each low-income beneficiaries who need and maintenance session the beneficiary individual, which is expected to lead to MDPP services the most struggle attends. In response to comments, we a reduction in the incidence of diabetes. disproportionately to achieve the are also adding a definition for We do not have data to support an required weight loss and will not be maintenance session bundle to refer to expanded model that does not require able to access ongoing maintenance each 3-month interval of core the achievement and maintenance of the sessions. maintenance or ongoing maintenance minimum weight loss. We clarify that One commenter suggested that CMS sessions. Each bundle must include at beneficiaries have access to the MDPP use an aggregate, not individual, 5 least one maintenance session per core benefit regardless of weight loss. percent weight loss across a supplier’s month, for a minimum of three sessions This provides all eligible beneficiaries beneficiaries to align with the CDC in each bundle. with access to 12 months of MDPP DPRP Standards and promote ongoing We acknowledge some commenters’ services, without cost-sharing, to maintenance session eligibility for desire for CMS to cover ongoing achieve the target weight loss. We populations that experience difficulty maintenance sessions for beneficiaries believe the incentive to achieve the achieving the 5 percent weight loss due who do not achieve and maintain the target weight loss would be diluted for

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beneficiaries if they could access the sessions in future rulemaking. As into the Diabetes Self-Management ongoing maintenance sessions acknowledged by several commenters, Training (DSMT) benefit. regardless of weight loss. continued participation by an Response: We agree with commenters Comment: Commenters recommended individual in a DPP after year 3 has that MDPP suppliers should be limiting the number of years of payment been generally untested, and we intend permitted to, consistent with their CDC for ongoing maintenance sessions due to to take this into consideration when we DPRP recognition, use any curriculum the limited administrative and address a limit in future rulemaking. approved by the CDC. The CDC- operational capability of many MDPP In response to comments on the preferred curriculum is available at suppliers to provide ongoing provision of services outside of MDPP, http://www.cdc.gov/diabetes/ maintenance sessions in perpetuity. A the MDPP model expansion only prevention/lifestyle-program/ few commenters opposed payment for includes MDPP services. We note the curriculum.html. We note that if a DPP ongoing maintenance sessions at all, distinction between core maintenance organization chooses to use a different stating that indefinite monthly sessions and ongoing maintenance curriculum, it must send the curriculum maintenance sessions extend beyond sessions is important in that core to the CDC DPRP so it can be evaluated what is supported by scientific research. maintenance sessions are a part of the to ensure that it covers similar content The commenters recommended core benefit and are accessible to all and is consistent with the current additional review of clinical eligible beneficiaries, while ongoing evidence base. To mitigate confusion effectiveness and cost implications of maintenance sessions require surrounding the use of specific topic payment for ongoing maintenance beneficiaries to maintain weight loss names, we will remove specific sessions, suggesting that we study the after the 12 month core benefit. As curriculum topics from the regulations optimal number of maintenance mentioned in section III.J.6. of this final text and instead specify that the sessions for beneficiaries who achieve rule, we defer questions of beneficiary sessions must be furnished consistent and maintain the required weight loss. attribution, such as how to address with any CDC-approved curriculum. We One commenter recommended that we beneficiaries who switch suppliers upon believe this change also will make it eliminate ongoing maintenance sessions the transition from the core benefit to unnecessary for us to undertake or make them voluntary for MDPP ongoing maintenance sessions, to future rulemaking to address regular CDC suppliers to furnish. The commenter rulemaking. curriculum updates. This will reduce noted the potential difficulty of Comment: Numerous commenters the risk that MDPP suppliers would assembling enough ongoing supported the use of CDC’s DPRP need to have two separate curricula, one maintenance session attendees to cover Standards for the MDPP curriculum. for their Medicare beneficiaries and one a supplier’s costs due to factors such as Several commenters suggested that we for the rest of their enrollees, which beneficiary attrition or schedule permit MDPP suppliers to furnish any could be unnecessarily burdensome. variation and administrative burdens CDC-approved curriculum, rather than For the ongoing maintenance session associated with documenting requiring the use of a particular curriculum, we are requiring that MDPP beneficiary eligibility. The commenter curriculum. Commenters stated that suppliers use a CDC-approved also suggested that we clarify whether CDC regularly updates its suggested curriculum. The purpose of ongoing MDPP suppliers can offer and charge curriculum, as well as reviews and maintenance sessions is to reinforce and beneficiaries directly for additional approves alternative curricula that are revisit what was learned and practiced services, such as health coaching submitted with an organization’s in the core benefit, so beneficiaries can beyond MDPP services or counseling to application for CDC DPRP recognition. maintain healthy behavioral changes beneficiaries who regain weight and are Commenters requested clarification on and weight loss. Coaches can offer any no longer receiving MDPP services. whether suppliers may use the 2016 of the curriculum topics except for the One commenter recommended that CDC Prevent T2 Curriculum or the 2012 introductory sessions. We support the we clarify whether beneficiaries must CDC-developed curriculum, both of use of culturally sensitive curricula participate with the same coach or which are permitted by the CDC DPRP based on the MDPP supplier’s group of beneficiaries upon the Standards. Commenters recommended population and furnishing MDPP transition from the core benefit to that CMS clarify whether CMS would services in languages other than English. ongoing maintenance sessions. Another need to undergo a rule change if CDC If the CDC approves a curriculum that commenter recommended that CMS use makes changes to the curriculum. has adjustments to address language different terminology for the ongoing Commenters also suggested barriers or cultural differences, the maintenance sessions after the 12- clarification on the curriculum topics MDPP supplier can use the curriculum. month core benefit because it is that MDPP suppliers should follow for We remind organizations that the confusing that the core maintenance ongoing maintenance sessions, as the policies and procedures of approved sessions in the second 6 months are also National DPP curriculum only specifies curricula must ensure accessibility to called maintenance sessions. content for what is analogous to the persons with disabilities, persons with Response: We believe it is important MDPP core benefit. Other commenters limited English proficiency, and other for CMS to cover ongoing maintenance recommended allowing MDPP suppliers populations in compliance with HHS sessions after the 12-month core benefit to use the CDC-approved DPP civil rights non-discrimination to better equip beneficiaries to maintain curriculum in another language or regulations, including those healthy lifestyle changes and prevent making the curriculum more culturally implementing section 504 of the type 2 diabetes. As part of the expanded sensitive. Commenters suggested Rehabilitation Act of 1973, Title VI of model, MDPP suppliers are required to changes to the curriculum, such as the Civil Rights Act, section 1557 of the provide eligible beneficiaries access to shifting the focus away from calorie Patient Protection and Affordable Care ongoing maintenance sessions. We counting, emphasizing physical activity Act, and Title IX of the Education acknowledge commenters’ concern and exercise goals, training coaches to Amendments of 1972, as amended. regarding the sustainability of ongoing handle emotional issues and offering More information is available at http:// maintenance sessions in perpetuity, and oral hygiene sessions. www.hhs.gov/civil-rights. With respect we intend to propose a limit to the One commenter suggested we to embedding the DPP curriculum into duration of ongoing maintenance consider ways to embed the curriculum DSMT, we decline to adopt this

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recommendation. As noted previously, We are also finalizing the proposal that Response: We appreciate the views of DSMT and MDPP services, though beneficiaries have access to ongoing commenters, including MedPAC. We similar, serve different purposes and are maintenance sessions after the 12- are considering ways to monitor for for individuals with different needs. month core benefit if they achieve and MDPP suppliers who consistently bill Comment: Some commenters maintain the required minimum weight for session attendance and not weight recommended that CMS modify the loss of 5 percent. We are modifying the loss, and intend to address this in our session duration requirement from ‘‘at regulations in § 410.79 to add the program integrity and payment least one hour’’ to align with the CDC definition of ‘‘maintenance session proposals in future rulemaking. We DPRP Standards of ‘‘each session must bundle’’ to refer to each 3-month recognize that performing mental be of sufficient duration to convey the interval of core maintenance or ongoing capacity assessment prior to enrollment session content—or approximately one maintenance sessions, with at least one would be difficult and create an hour in length.’’ Commenters stated that maintenance session delivered in each additional burden for MDPP suppliers. the time it takes to complete a of the 3 months. We are also adding the We will consider how to address the curriculum topic depends on the definition of ‘‘maintenance of weight issue of beneficiaries who are eligible to number of attendees, how the services loss’’ to clarify that maintenance of receive MDPP services, but for whom are furnished, beneficiaries’ assessed weight loss is achieving the required MDPP may not be clinically need, the curriculum topic, and the minimum weight loss from baseline appropriate, in future rulemaking, as approach to the curriculum, and the weight at any point during each 3- necessary. one-hour requirement would be too month core maintenance or ongoing Comment: Many commenters stated rigid and too long for many CDC- maintenance session bundle. We are recognized organizations. Other that differences between the MDPP revising the definitions of the CDC- expanded model’s proposed eligibility commenters recommended we focus on approved core curriculum to remove completion of modules in the required criteria and the National DPP eligibility specific curriculum topic names and to criteria will cause confusion for curriculum, not session-based time indicate MDPP suppliers must use any standards, since module completion providers and beneficiaries. CDC-approved curriculum. We are Commenters specifically noted that the requires active participation and the revising the session duration to specify ability to turn learning into action, BMI cut off for National DPP eligibility that sessions must have a duration of 2 2 while a time-based standard does not is 24 kg/m and 22 kg/m for those self- approximately one hour. We are also identified as Asian, whereas the correlate with impact on outcomes. making minor technical changes to the Some commenters stated that value- proposed BMI cut offs for the MDPP proposed definitions to improve clarity. 2 based care de-emphasizes the amount of expanded model are 25 kg/m and 23 2 time involved with furnishing a given 6. Beneficiary Eligibility kgm for those self-identified as Asian. service and focuses on the results Commenters also noted the differences achieved. a. MDPP Eligible Beneficiaries in the blood test criteria for the fasting Response: We agree with commenters plasma glucose test between the We proposed that coverage of MDPP National DPP (range is 100–125 mg/dL) that the one-hour requirement may be services would be available for too rigid when compared against CDC- and MDPP expanded model (range is beneficiaries who meet all of the 110–125 mg/dL). Commenters who approved DPP curricula that vary in following criteria: (1) Are enrolled in approach and mode of delivery. We pointed out these differences Medicare Part B; (2) have, as of the date recommended that CMS align its agree that ‘‘approximately one-hour in of attendance at the first core session, a duration’’ is an appropriate requirement eligibility criteria with CDC’s eligibility body mass index (BMI) of at least 25 if criteria. for in-person sessions because not self-identified as Asian or a BMI of completion of a curriculum topic may at least 23 if self-identified as Asian. Several commenters also supported vary depending on factors such as The CDC DPRP Standards have defined the lower BMI threshold for self- number of attendees, how the program a lower BMI for self-identified Asian identified Asians. is delivered, beneficiaries’ assessed individuals based on data that show Response: We agree with commenters need, the curriculum topic, and the Asians develop abnormal glucose levels that there are differences between the approach to the curriculum. We do not at a lower BMI; (3) have, within the 12 MDPP beneficiary eligibility criteria and believe the CDC DPRP Standard that months prior to attending the first core National DPP eligibility criteria, which ‘‘each session must be of sufficient session, a hemoglobin A1c (HgA1c) test may be a source of confusion for duration to convey the session content’’ with a value between 5.7 and 6.4 suppliers, providers and beneficiaries. is an auditable requirement, and percent, or a fasting plasma glucose of therefore, we decline to adopt it for However, we proposed a BMI cut off for 110–125 mg/dL, or a 2-hour post- 2 MDPP because, as noted in the proposed non-Asians of 25 kg/m because this rule, having auditable requirements is a glucose challenge of 140–199 mg/dL was the cut off used in the DPP model critical component of our program (oral glucose tolerance test); (4) have no test. In addition, the generally accepted integrity efforts. For these reasons, we previous diagnosis of type 1 or type 2 clinical definition of overweight is a are amending our regulations to specify diabetes with the exception of a BMI of 25.0—29.9 in adults over age 23 that sessions must be ‘‘approximately previous diagnosis of gestational 20. We proposed a lower BMI cut off 2 one-hour in duration.’’ diabetes; and (5) does not have end- for self-identified Asians of 23 kg/m Final Decision: After consideration of stage renal disease (ESRD). which is endorsed by the American the public comments received, we are Comment: MedPAC commented that Diabetes Association and aligns with the finalizing the proposal that the MDPP the proposed eligibility requirements CDC DPRP Standards which allow for a core benefit is a 12 consecutive month may be too broad and could result in the lower BMI in self-identified Asians program that consists of at least 16 inclusion of beneficiaries who meet the weekly core sessions over months 1–6 stated eligibility criteria but have other 23 Centers for Disease Control and Prevention, ‘‘Healthy Weight,’’ Centers for Disease Control and and at least six monthly core conditions such as dementia or frailty Prevention, 2015, https://www.cdc.gov/ maintenance sessions over months 6– that could render a weight loss program healthyweight/assessing/bmi/adult_bmi/ 12, furnished regardless of weight loss. inappropriate. index.html.

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consistent with the latest research.24 In Comment: Commenters requested that beneficiaries can participate in summary, the evidence used to make clarity on how suppliers would verify MDPP regardless of a history of the certification determination indicated that beneficiaries meet certain eligibility gestational diabetes (so long as they do that individuals who fall into the 100– criteria. Specifically, commenters asked not have a history of type 1 or type 2 110mg/dL range for fasting plasma how suppliers would determine diabetes), but must also meet the other glucose and those with BMIs of 24 kg/ whether a Medicare beneficiary has had criteria such as qualifying BMI and m2 (22 kg/m2 for Asians) or less have a prior diagnosis of type 1 or type 2 blood test results. lower risk for developing type 2 diabetes, or whether they have already We believe the requirement to obtain diabetes. We have chosen to focus on used the benefit. Commenters requested blood test results is important for the highest risk population, and clarity that beneficiaries would be able maintaining program integrity, and use therefore the Chief Actuary’s analysis to self-report their history of gestational of risk questionnaires presents for certification focused on this diabetes to become eligible for MDPP. opportunities for invalid and unreliable population.25 26 Commenters also encouraged us to data reporting. The DPP model test Comment: Several commenters stated explain what documentation MDPP required blood test results as part of its that Medicare currently does not cover suppliers will be required to collect eligibility criteria to show a beneficiary the HgA1c test for people without from participants who are presenting has pre-diabetes, and therefore we are diabetes. These commenters MDPP-qualifying blood test results to requiring blood tests for MDPP recommended that the HgA1c test be confirm eligibility. Commenters also eligibility. In considering how to covered with no cost-sharing under suggested allowing beneficiaries to expand the DPP model test, we relied on Medicare for those seeking to receive complete an eligible risk questionnaire eligibility criteria that was either tested MDPP services. Commenters suggested in lieu of the qualifying lab tests for up in the initial DPP model test and/or set the precedent of Diabetes Self- to 50 percent of their participants as this forth by the American Diabetes Management Training (DSMT) requiring would align with the current CDC DPRP Association or World Health HgA1c as a diagnostic test for DSMT Standards for eligibility. Commenters Organization, and we do not intend to eligibility, and that the test is covered suggested using other types of criteria include additional eligibility criteria at for this purpose. Commenters such as family history, hypertension, this time. recommended a parallel coverage high cholesterol, and high triglycerides, Regarding comments about the determination should be made for the to determine eligibility among patients timeframe of eligibility tests and MDPP expanded model. One for whom abnormal blood glucose required documentation: We did not commenter stated that the oral glucose values are not available. One commenter propose specific requirements for how tolerance test should be covered if it is requested that we clarify the timeframe or where blood test results may be obtained as we do not want to create being considered as one of the eligibility in which the BMI and blood tests must unnecessary obstacles for beneficiaries tests. occur to qualify for participation, such Response: CDC standards for and MDPP suppliers. An MDPP supplier as whether the beneficiary has to have eligibility, which align with the may administer an HgA1c finger prick a qualifying BMI either when the blood American Diabetes Association to determine eligibility. We note that tests were completed or upon definition for pre-diabetes, include an Medicare only covers the fasting plasma enrollment. Other commenters option for demonstrating eligibility glucose test and the oral glucose requested guidance on whether the using an HgA1c test and we proposed to tolerance test when the beneficiary has blood tests have to come from a lab or adopt these eligibility standards for the a referral from his or her primary care primary care physician or if the supplier MDPP expanded model. However, the physician or qualifying provider. can provide HgA1c finger pricks to blood tests that are permitted to be used Similarly, we did not propose specific to demonstrate MDPP eligibility are not determine eligibility. Commenters also documentation methods beyond our covered as part of the MDPP services asked if proof of lab work is required or proposal that MDPP suppliers maintain and occur before the start of the if documentation of the values is records that document each beneficiary’s participation in MDPP. We sufficient. MedPAC commented that beneficiary’s eligibility status. We will did not propose to cover HgA1C tests for beneficiaries should receive blood tests consider whether it is necessary or purposes of screening for pre-diabetes, by a provider other than the MDPP appropriate to establish specific but we note that the other blood tests supplier as a safeguard to prevent fraud. documentation standards in future that can be used to demonstrate Response: The following eligibility rulemaking. eligibility for MDPP services, the oral criteria can be self-reported: Asian Comment: Commenters requested glucose tolerance test and fasting ethnicity; no history of type 1 or type 2 guidance on how to handle beneficiaries plasma glucose test, are covered for pre- diabetes; and no previous receipt of who are diagnosed with diabetes during diabetes screening under Medicare. To MDPP services. We cannot verify self- the screening process or while receiving cover HgA1C tests for purposes of reported eligibility criteria when MDPP services. Commenters screening for pre-diabetes, we would beneficiaries begin receiving MDPP recommended we work with CDC to first need to make a separate coverage services. We will know which develop a protocol of how to address determination. beneficiaries are participating in MDPP beneficiaries who receive a diagnosis of when the MDPP supplier submits diabetes while being screened for or 24 William Hsu et al., ‘‘BMI Cut Points to Identify claims with beneficiary identifiers. In while receiving MDPP services. Several At-Risk Asian Americans for Type 2 Diabetes our next round of rulemaking we intend commenters stated that this protocol Screening,’’ Diabetes Care 38, no. 1 (2015): 150– to propose specific policies and 158. should ensure participants receive 25 Gregory Nichols et al., ‘‘Trends in Diabetes requirements to protect MDPP suppliers proper care and a referral into a DSMT Incidence Among 7 Million Insured Adults, 2006– from furnishing services that may not be program. 2011: the SUPREME–DM Project,’’ American covered by Medicare in cases where the Response: We reiterate that Journal of Epidemiology 181, no. 1 (2015): 32–39. beneficiary’s eligibility for MDPP beneficiaries who are diagnosed with 26 DH Morris et al., ‘‘Progression Rates from HbA1c 6.0–6.4% and Other Prediabetes Definitions services is assessed based on self- diabetes before they begin receiving to Type 2 Diabetes: a Meta-Analysis,’’ Diabetologia reported eligibility criteria that cannot MDPP services, such as during the 56, no. 7 (2013): 1489–1493. be verified prospectively. We clarify enrollment process, based on their lab

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results or history of type 1 or type 2 b. Limitations on Coverage available only once per lifetime per diabetes are not eligible beneficiaries. We proposed that beneficiaries who MDPP eligible beneficiary, and ongoing These beneficiaries may be eligible for meet the beneficiary eligibility criteria maintenance sessions are available only other types of diabetes-related care would be able to receive MDPP services if the MDPP eligible beneficiary has under Medicare, such as DSMT. only once in their lifetime. achieved maintenance of weight loss. We did not propose an eligibility Comment: Many commenters asked These limitations are specified in policy for beneficiaries who receive a CMS to allow exceptions to the once per § 410.79. diagnosis of diabetes while receiving lifetime restriction based on significant c. Referrals MDPP services. However, we agree with life events. Commenters recommended The DPP currently allows community- commenters that a protocol needs to be that CMS allow beneficiaries to access referral such as by Y–USA and self- developed to ensure beneficiaries who the benefit again after a certain period referral of patients, in addition to are diagnosed with diabetes while of time (for example, 6 months or 1 referral by physicians and other health receiving MDPP services are receiving year) and to allow beneficiaries to care practitioners, if the patient presents the proper care for their condition. We access MDPP services at least two times DPP-qualifying blood test results that intend to address this issue in future in their lifetime. Several commenters the DPP organization keeps on record. rulemaking. suggested the lifetime benefit policy We proposed to similarly permit Comment: A number of commenters may be unfair due to extenuating beneficiaries who meet our eligibility requested that we include populations circumstances that may arise throughout criteria to obtain MDPP services by self- beyond those that meet the eligibility the core benefit, such as hospitalization referral, community-referral, or health criteria, such as all Medicare or death of a loved one. care practitioner-referral. beneficiaries, Medicaid beneficiaries, Commenters also requested clarity on The following is a summary of the those with ESRD and those who have how we may handle attribution if comments received and our responses. been diagnosed with type 1 or type 2 beneficiaries switch suppliers. One Comment: Commenters generally diabetes. Additionally, one commenter commenter believed there may be supported our proposal allowing for suggested that beneficiaries who do not operational implications of managing self-referral, community-referral, or meet the BMI criteria, but have a family this benefit across hundreds of suppliers health care practitioner referral to obtain history of diabetes and motivation to should participants change suppliers or MDPP services, although MedPAC receive MDPP services, should be able elect to withdraw from MDPP while it expressed concern that MDPP services to do so. is underway and re-enroll at a later date. could be inappropriately used and Response: We believe that The commenter recommended that we suppliers could initiate services without beneficiaries who meet the eligibility issue guidelines on how MDPP a referral. Commenters suggested that criteria that we proposed are the most suppliers should address changes, we broaden the types of providers appropriate population to access MDPP particularly with respect to beneficiary eligible to make referrals to MDPP services because these beneficiaries are eligibility and billing and suppliers. For example, a commenter among the highest risk within the pre- reimbursement. recommended clarification of what Response: We understand concerns diabetic population for developing types of provider referrals would be regarding the potential for life events to diabetes. Targeting lower risk permitted for MDPP and recommended disrupt the beneficiary’s receipt of beneficiaries is not consistent with the that such providers include nurse MDPP services. However, the MDPP model that we are expanding. practitioners to broaden program access; expansion is designed to generate Beneficiaries with type 1 or type 2 another commenter suggested that we savings for the Medicare program by diabetes do not meet the eligibility will be able to increase access to and preventing individuals with pre- criteria for MDPP but may be eligible for streamline beneficiary access to MDPP diabetes from developing type 2 services such as Medicare’s obesity services by allowing community-based diabetes. We believe the once per counseling benefit and DSMT. We do organizations to refer beneficiaries. lifetime restriction is necessary in order not believe MDPP is appropriate for Many commenters recommended that to generate enough savings to offset the those with ESRD because beneficiaries we promote referrals from MDPP cost of delivering MDPP services. with ESRD have more complex dietary suppliers to psychologists to help We are finalizing the policy that requirements that are better addressed address psychosocial components of eligible beneficiaries can participate in by dieticians and other health care their care. Other commenters opposed a MDPP only once in their lifetimes. professionals. physician referral requirement. One However, we acknowledge the commenter opposed the requirement of We appreciate the commenters’ commenters’ concerns, and plan to blood tests as part of referral pathway. interest in Medicaid coverage. However, address any exceptions to the once per Some commenters recommended that this model expansion pertains only to lifetime restriction in future rulemaking we explicitly state that MDPP services Medicare beneficiaries, though we note as appropriate. As we did not propose will be paid for when ordered/referred that Medicaid beneficiaries who are also to restrict eligible beneficiaries’ choice by non-physician practitioners. A Medicare beneficiaries are eligible if of MDPP suppliers, we are confirming commenter recommended that we they meet the MDPP beneficiary that they will be able to change require non-clinician health care MDPP eligibility requirements. We encourage suppliers at any time; however, because suppliers to ask beneficiaries about their states to work with the Center for beneficiary attribution directly relates to usual source of care and mandate that Medicaid & CHIP Services (CMCS) to payment, we will consider the MDPP suppliers share results with the discuss options to cover diabetes comments on how to address attribution beneficiary’s self-identified primary care preventive services within the Medicaid and its attendant effect on payment in physician. program. developing proposals for future Response: We agree with commenters Final Decisions: We are finalizing the rulemaking. that there should be broad program beneficiary eligibility criteria as Final Decision: We will finalize access, which is why we are not proposed. These criteria are set forth in limitations on coverage of MDPP as requiring any specific type of referral for § 410.79. proposed. The MDPP core benefit is this expanded model test. With respect

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to the comments on program integrity, MDPP suppliers have some similarities medical insight or oversight as we will take these comments into to home health agencies, a provider necessary. consideration in future rulemaking, as screened according to the high Many commenters who supported discussed in section III.J.8.b. of this final categorical risk category, because non- allowing these organizations to enroll in rule. We agree with commenters and licensed personnel may furnish MDPP Medicare as MDPP suppliers clarify that non-physician practitioners services in a non-clinical setting, such recommended that the enrollment can order or refer eligible beneficiaries as at Y–USA. policies should be aligned as closely to for MDPP services. We understand the We proposed that existing Medicare CDC DPRP Standards as possible to value of coordinating results from the providers and suppliers that wish to bill avoid additional burden to MDPP with a beneficiary’s primary care for MDPP services would have to inform organizations that are less familiar with provider, however, we will not require us of that intention and satisfy all other Medicare rules and regulations. this type of coordination because we requirements, such as preliminary or Response: We appreciate the believe it creates an additional burden full CDC DPRP recognition, but would commenters’ support for allowing for this new supplier type that will not need to enroll a second time. These organizations that meet the MDPP discourage DPP organizations from existing Medicare providers and supplier eligibility criteria to enroll in enrolling in Medicare as MDPP suppliers would be eligible to bill for Medicare, even for those that in other suppliers. Additionally, the MDPP MDPP services furnished on or after circumstances would be ineligible to suppliers have no reimbursement January 1, 2018. We also considered an enroll in Medicare. As described in mechanism for coordinating services alternative approach where existing detail in section III.J.7.c. of this final with primary care physicians, Medicare providers and suppliers rule, the literature does not support the specialists or other providers. The would have to submit a separate need for coaches to have clinical value-based payment proposed for the enrollment application (including any credentials to successfully achieve the MDPP expanded model affords no applicable enrollment application fee) behavior change MDPP seeks to compensation for coordination among and be separately screened to be eligible encourage. Therefore, we disagree with providers. We are concerned that to bill for MDPP services. This commenters who suggested requiring holding MDPP suppliers to a higher alternative would enable all that these new suppliers enroll with a clinical affiliate, that is, a provider or service coordination standard than other organizations furnishing MDPP services supplier that is currently enrolled in Medicare suppliers and providers may to have the same classification as MDPP Medicare and currently furnishes negatively impact MDPP supplier suppliers and undergo the same capacity. We do not believe it is services. application requirements. Under this For those who requested that we appropriate to address referrals from option, should an entity have an issue closely align MDPP supplier eligibility MDPP suppliers to other providers in related to their MDPP enrollment, for requirements to the DPP organization this expansion because suppliers may or example, falsely attesting to beneficiary recognition requirements in the CDC may not employ providers with the weight loss, CMS would have discretion DPRP Standards, an organization that credentials to make referrals to other to apply revocation to its MDPP obtains CDC DPRP recognition can providers, and we believe this is beyond enrollment, rather than affecting their become an MDPP supplier if they meet the parameters of the MDPP expanded broader enrollment in Medicare. a few additional Medicare requirements. model. We proposed to require that all MDPP Comment: Some commenters Final Decision: We are finalizing the suppliers comply with applicable disagreed with requiring community- procedure for referrals to MDPP as Medicare supplier enrollment, program based organizations to enroll as an proposed. integrity, and payment rules. These MDPP supplier in order to furnish 7. Enrollment of MDPP Suppliers regulations include, but are not limited MDPP services, stating that the to, time limits for filing claims enrollment process would be too a. MDPP Supplier Enrollment (§ 424.44), requirements to report and burdensome. Others recommended that Requirements return overpayments (§ 401.305), and due to the burden that enrolling as a We proposed that any organization procedures for suspending, offsetting or Medicare supplier could place on with preliminary or full CDC DPRP recouping Medicare payments in certain smaller, community-based organizations recognition would be eligible to apply situations (§ 405.371). that wish to furnish MDPP services, we for enrollment in Medicare as an MDPP The following is a summary of the should offer them an easier, expedited supplier beginning on or after January 1, comments we received regarding enrollment process that is less complex 2017. This proposal would promote supplier enrollment. and burdensome. Other commenters timely enrollment of CDC-recognized Comment: Several commenters noted that given the burden that organizations before the MDPP supported the proposal to allow enrolling, recordkeeping, and billing expanded model becomes effective on organizations that previously would not could impose on these organizations, January 1, 2018. We proposed that be eligible to enroll in Medicare to particularly smaller community-based MDPP suppliers would be subject to the enroll as MDPP suppliers. One organizations, many such organizations enrollment regulations set forth in 42 commenter stated that enabling utilize third party administrators to CFR part 424, subpart P. organizations with either preliminary or assume these roles on their behalf. Organizations seeking to enroll in full CDC DPRP recognition to furnish Commenters recommended that we Medicare to become MDPP suppliers MDPP services as officially enrolled consider the role that third party would be subject to screening under suppliers is an important step in administrators, which are not CDC- § 424.518. We proposed that potential validating community health workers’ recognized to deliver DPP, could play in MDPP suppliers be screened according place in the health care system. Other MDPP, particularly providing to the high categorical risk category commenters stated that these administrative services to new Medicare defined in § 424.518(c) because the organizations should be able to enroll suppliers to lighten their burden. MDPP expanded model allows and furnish MDPP services, but that Response: We acknowledge that organization types that are new to they should do so with a clinical smaller, community-based organizations Medicare to enroll. We also believe that affiliate to serve as a resource to provide without experience in the traditional

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health care system may not be familiar who furnishes health care in the normal furnished in community-based settings, with Medicare’s enrollment course of business is a health care the physical location associated with requirements, and may find Medicare provider. Section 45 CFR 160.103 the MDPP supplier’s base of operations enrollment burdensome. Medicare defines ‘‘health care’’ to include, among in each state, as indicated on their enrollment is the process through which other things, preventive services. enrollment application, would meet the suppliers acquire eligibility to submit Because MDPP services are considered requirements for the qualified physical claims to Medicare to bill for services additional preventive services, we practice location, provided that the furnished. (In other contexts enrollment believe MDPP suppliers and coaches location was open and operational as can also be the process used to establish who furnish MDPP in the normal course described in Chapter 15 of Medicare’s eligibility to order or certify Medicare of business are furnishing health care Program Integrity Manual, Section covered items and services.) and therefore qualify as health care 19.2.2. As described in III.J.7.e. of this Furthermore, enrolling into Medicare providers that are eligible for NPIs final rule, we will address policies also enables us to maintain program under 45 CFR part 162, subpart D. related to virtual DPP organizations in integrity through screening, monitoring We acknowledge commenters’ future rulemaking. and revocation. Thus, we believe the questions regarding which provider Comment: Several commenters agreed benefits of enrollment, even for smaller taxonomy to include when applying for with our proposal that we would screen community-based organizations, an NPI, as well as which supplier type MDPP suppliers as high categorical risk. outweigh the costs of the associated MDPP organizations would denote Many other commenters disagreed and administrative burden. We note that when enrolling. We plan to issue stated that MDPP, like Diabetes Self- organizations that face financial additional details through guidance or Management Training (DSMT), is difficulty related to the enrollment future rulemaking as appropriate to help educational by teaching beneficiaries application fee may apply for a hardship guide organizations in applying for an about eating healthy and being active, exception. For more information on the NPI. For the purposes of providing which makes MDPP suppliers more hardship exemption, please visit: guidance in this final rule, we would analogous to DSMT organizations than https://www.cms.gov/Outreach-and- like to note for DPP organizations that Home Health Agencies (HHAs). Both the Education/Medicare-Learning-Network- we believe the taxonomy code of Health MDPP expanded model and DSMT are MLN/MLNMattersArticles/downloads/ Educator (174H00000X) could be educational in nature, and both MDPP MM7350.pdf. appropriate for MDPP suppliers when and DSMT organizations require We recognize the role that third party applying for an NPI. As for supplier recognition or accreditation by a third administrators may play in facilitating type to denote upon applying to enroll party organization or agency to be the enrollment process for DPP in Medicare, we intend to create a new eligible to furnish services. Given these organizations. We intend to allow MDPP supplier type, specific to MDPP similarities, commenters noted that suppliers to utilize third-party suppliers, and may release an organizations that enroll as DSMT administrators for the purposes of appropriate application form providers are screened according to the enrollment but will further consider accordingly. limited categorical risk, and therefore how these entities may fit into the Comment: Many commenters sought MDPP suppliers should similarly be MDPP enrollment and policy framework clarity regarding enrolling suppliers screened at the limited categorical risk. in future rulemaking, as appropriate. new to Medicare. One commenter asked Some commenters stated that MDPP Comment: A few commenters whether these suppliers could furnish suppliers should face less scrutiny and questioned whether new suppliers MDPP services at community locations screening than that of medical could obtain a National Provider such as faith-based organizations and professionals because of the Identifier (NPI) to become eligible to community centers, as was permitted in fundamental difference between the enroll in Medicare. Some commenters the DPP model test. One commenter educational MDPP and the medical believed that many DPP organizations stated that DSMT and MDPP should be services furnished by traditional with CDC DPRP recognition do not meet subject to consistent rules, but noted Medicare providers. the requirements to obtain an NPI given that current rules for DSMT do not Other commenters disagreed with the definition of health care provider permit hospital-based programs to be CMS’ parallel between HHAs and under 45 CFR 160.103, and requested offered at community locations. Another MDPP, noting that the requirement to that we explain how unlicensed commenter noted that while we do not obtain CDC DPRP recognition organizations and individuals with no define ‘‘qualified physical practice establishes a higher level of program health care experience qualify for an location,’’ the Medicare Program integrity than that faced by HHAs. One NPI. Integrity Manual suggests that in order commenter noted that Durable Medical Commenters requested clarity to enroll in Medicare, organizations Equipment, Prosthetics/Orthotics, and regarding what supplier type an MDPP must have a physical location where a Supplies (DMEPOS) suppliers and supplier would indicate on the Medicare beneficiary could visit in HHAs became classified as high Medicare enrollment application. Other person. This commenter recommended categorical risk in response to reports commenters requested clarity on what that CMS clarify how suppliers issued by the HHS Office of Inspector taxonomy code suppliers would use furnishing virtual DPP services would General (HHS–OIG) and the when applying for their NPI. meet this physical location requirement, Government Accountability Office Response: We disagree with whether it would be waived, or whether (GAO). commenters who stated that some their company headquarters would Response: We understand that MDPP organizations that meet the MDPP serve as the ‘‘qualified physical practice bears similarities to an educational supplier requirements would be unable location.’’ service like DSMT, but do not agree to obtain an NPI. Under 45 CFR part Response: Consistent with the DPP with commenters who stated MDPP 162, subpart D, health care providers, as model test, MDPP suppliers will be able suppliers should face less scrutiny or defined in 45 CFR 160.103, may obtain to provide the service at community- screening than that of medical NPIs. The definition of health care locations such as faith-based professionals. CMS assigns risk level provider at 45 CFR 160.103 specifies, in organizations and community centers. based not on the nature of the benefit part, that any person or organization Given that MDPP services can be that the supplier furnishes, but on the

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level of risk that the supplier type may high categorical risk screening. One not believe this additional cost of high pose to the Medicare program. commenter stated that for entities that screening is cost prohibitive for Therefore, we disagree with commenters are corporately owned or traded, enrollment, even for smaller who sought a limited screening level for requirements for regional, privately community-based organizations. We MDPP suppliers on the basis that DSMT owned suppliers may not be appropriate understand the commenter’s concern suppliers face limited screening. Fewer given the different ownership structures that for entities that are corporately organizations are eligible to furnish that are not well captured by CMS’s owned or traded, screening DSMT than MDPP because DSMT enrollment applications. A few requirements and CMS’s enrollment organizations must already be enrolled commenters also noted that suppliers applications may be difficult or may not in Medicare to furnish services other newly enrolled into Medicare for MDPP, be applicable given the different than DSMT. Due to their existing and providers or suppliers with existing ownership structures. We will not enrollments, all DSMT providers are enrollment in Medicare who wish to change our requirement to collect affiliated with medical professionals furnish MDPP, should be screened at fingerprints from all individuals with a enrolled in Medicare. Medical the same level. direct or indirect ownership interest, professionals face many additional Response: While we agree that CDC though we recognize that not all regulations outside of those set by ensures the quality of DPP programs suppliers under this requirement will Medicare, including state licensure using performance data, which will help have individual owners who meet this requirements that help to protect against ensure the quality of MDPP suppliers, criterion. However, when an individual fraud or abuse by these individuals. CDC is not a regulatory body has 5 percent or more direct or indirect This is not comparable to MDPP responsible for the integrity of Medicare ownership in a prospective MDPP suppliers that are not required to have payments. We therefore disagree that supplier, whether private or publically an existing enrollment in Medicare. program integrity policies in Medicare traded, submitting a set of fingerprints Given the requirements that would duplicate CDC’s random site would be required for enrollment into credentialing and licensure place on visits and audits of DPP organizations Medicare. these providers, the DSMT supplier type because the agencies play different We refer those interested in learning poses less risk to Medicare than roles. CMS’s program integrity and more about the requirements associated suppliers like HHAs and DMEPOS audits focus on payments, whereas CDC with a high screening level to § 424.518. suppliers that do not have the same focuses on monitoring whether Given the nominal financial difference credentialing and licensure organizations are meeting the CDC of obtaining fingerprints from 5 percent requirements to serve as an additional DPRP standards. or more owners, we do not believe that check on fraud or abuse in addition to We agree with commenters who noted application of the high screening level Medicare efforts. Similar to home health that suppliers newly enrolling into will be a barrier to organizations to aides, individuals who furnish MDPP Medicare for MDPP should be screened enroll in Medicare as an MDPP supplier. services are not required to have at the same level as those with existing Additionally, we expect that MDPP medical credentials or state licensure. enrollment in Medicare who wish to suppliers will revalidate at a moderate Given the similarities between MDPP furnish MDPP services. We risk level, consistent with the suppliers and HHAs, we believe the acknowledge the financial burden that revalidation policy of other high risk concerns HHS–OIG and GAO have enrolling may place on some suppliers. We will address the screening regarding HHAs’ vulnerability for fraud community-based DPP organizations. It level of MDPP suppliers seeking to and abuse could also apply to MDPP. is not our intent to hinder smaller revalidate in future rulemaking. We believe our policy to require high- organizations’ ability to enroll in Comment: Various commenters risk screening during enrollment will Medicare. We do not, however, believe recommended that we clarify whether safeguard against potential fraud and that a high screening level as opposed the MDPP supplier eligibility criteria abuse associated with this new supplier to limited or moderate would greatly would apply to existing providers and type. affect participation given the minimal suppliers in Medicare. Specifically, Comment: Some commenters stated additional requirements the higher commenters asked whether certified that the high categorical risk screening screening levels entail. The difference diabetes educators, pharmacies, requirement would carry a substantial between limited and high categorical pharmacists, physical therapists, financial burden that may discourage risk screening includes a site visit for registered dietitians, licensed clinical MDPP supplier enrollment. One each base of operations and social workers, and licensed commenter noted that the on-site visits fingerprinting of certain individuals naturopathic physicians who graduated required in moderate and high within the organization. This site visit from accredited medical schools would categorical risk screenings would be poses no cost to the supplier, and have the ability to bill Medicare for redundant to the CDC DPRP Standards should not delay the enrollment process MDPP services. Other commenters that already subject recognized beyond the 45 to 60 day window. highlighted that certain types of medical organizations to random audits and site Fingerprints are required of all professionals that are not currently visits. These commenters noted that individuals with 5 percent or more eligible to enroll in Medicare, like RNs, financial burdens may disproportionally ownership interest in the entity. have the capabilities to furnish MDPP affect community-based organizations Organizations would not be required to services as a coach, and requested the that are well-suited to furnish a submit fingerprints from managing ability to enroll in Medicare to furnish behavioral change program like the DPP. members, coaches, or other employees. and bill for MDPP services. Commenters highlighted that the burden The enrollment application fee a Some commenters noted that many of collecting fingerprints would supplier pays to Medicare is the same existing health care providers are well disproportionately affect independently regardless of screening level, therefore suited to furnish MDPP services, but run community-based organizations the only difference in cost to the may lack familiarity with the CDC more so than corporate entities that supplier amounts to the cost of National DPP and the process to obtain typically only have one central board. obtaining fingerprints of those with 5 CDC DPRP recognition. These Commenters also requested additional percent or more direct or indirect commenters recommended that CMS information on the requirements for ownership interest in the entity. We do provide education and outreach to these

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providers to ensure that they have the furnished face-to-face to a patient by a noted that consistency of procedures opportunity to obtain CDC DPRP RHC or FQHC practitioner. and guidelines among organizations recognition in a timely manner and RHCs and FQHCs can enroll as MDPP furnishing MDPP services, regardless of eligible to furnish MDPP services. suppliers if they otherwise meet the whether they were new entrants to Response: We appreciate interest from enrollment eligibility criteria, but we Medicare, would benefit the program to existing Medicare providers and clarify that MDPP is not a RHC/FQHC ensure the same requirements applied suppliers in furnishing MDPP services. service. However, a clinic that chooses across all entities furnishing MDPP Any organization that obtains CDC to furnish MDPP services could exclude services. DPRP recognition would be eligible to all costs related to furnishing MDPP Response: We agree with commenters enroll in Medicare as an MDPP supplier. services from its cost report and instead who support the alternative approach The CDC recognizes organizations, not submit claims for MDPP services under we proposed that suppliers and individuals. As such, only its separate MDPP supplier enrollment. providers with existing Medicare organizations, not individuals, would be RHCs and FQHCs must ensure that there enrollment enroll separately as an able to enroll as an MDPP supplier. Any is no commingling of RHC or FQHC MDPP supplier. We believe existing claims submitted for MDPP services resources in the cost report used to providers and suppliers will benefit would therefore be billed by the MDPP furnish MDPP services. We understand from a standardized procedure that all supplier, and not by an individual or that some clinics believe this will be MDPP suppliers follow. any other enrollment type a supplier burdensome, but only RHC or FQHC Though requiring existing Medicare may have. services can be billed on a UB–04 form. providers and suppliers to separately Although many individual clinicians Comment: Commenters generally enroll as MDPP suppliers initially could serve as MDPP coaches, we note supported the proposal that providers imposes an additional requirement, this that entities, not individuals, receive and suppliers with existing enrollment is a standard procedure for current CDC DPRP recognition. Furthermore, we in Medicare only be required to inform suppliers. Other types of Medicare us of their intent to furnish MDPP providers, such as hospitals or clinics would like to reiterate that entities services. A few commenters explicitly who wish to provide home health enrolled in Medicare for the sole stated that providers and suppliers with services, would similarly need to enroll purpose of furnishing MDPP services existing enrollment should not have to as HHA suppliers and undergo would be eligible to submit claims only create a separate enrollment as an MDPP screening requirements associated with for MDPP services. supplier to bill for MDPP services HHAs. We also believe this requirement We agree that many health care because the burden of doing so would would ultimately protect existing entities may be well suited to furnish unnecessarily discourage enrollment. In Medicare providers from revocation MDPP services but may lack familiarity support of this assertion, commenters action against their enrollment and with the CDC DPRP recognition process. stated that providers and suppliers with ability to furnish services outside of We will further consider the existing enrollment face stringent MDPP. For example, should an existing recommendations to undertake targeted regulations both from and outside of provider furnishing MDPP services lose education and outreach efforts to build Medicare requirements, and therefore CDC DPRP recognition, the provider supplier capacity. requiring an additional enrollment would be subject to revocation. If the Comment: Some commenters noted process for MDPP would only add provider were not enrolled separately as that rural health clinics (RHCs) and redundancy, rather than support a MDPP supplier, the provider’s federally qualified health centers program integrity concerns. One Medicare enrollment would be subject (FQHCs) serve beneficiaries who could commenter highlighted that under to revocation action, not just the billing benefit from MDPP services, and sought current CMS requirements, retail privileges associated with MDPP clarification and/or recommended that pharmacies must already undergo two services. As discussed in section RHCs and FQHCs be eligible to furnish enrollment processes and pay two III.J.7.d. of this final rule, many MDPP services. One of these application fees to serve dual roles as commenters agreed with the proposal commenters also recommended that we durable medical equipment suppliers that loss of CDC DPRP recognition allow RHCs to bill for MDPP services and mass immunizers. The commenter should result in revocation only of using the UB–04 form so that RHCs stated that an additional enrollment MDPP billing authorities, and not would not have to remove the cost of process and fee would not further necessarily affect the existing provider furnishing MDPP services from their protect against fraud and abuse, but or supplier’s eligibility to furnish and cost report, which they said would would simply add redundancy and bill for non-MDPP services. By requiring make the benefit too administratively inefficiency that could deter supplier all prospective MDPP suppliers— difficult to implement. uptake and limit beneficiary access. regardless of whether they have existing Response: RHC and FQHC services For providers and suppliers with enrollment in Medicare—to enroll as an are defined in section 1861(aa) of the existing enrollment in Medicare, some MDPP supplier, CMS has the discretion Act as services furnished by a commenters noted that they should not to target any revocation action against physician, nurse practitioner, physician have to be held to the CDC DPRP the MDPP supplier enrollment alone, assistant, certified nurse midwife, Standards, but instead meet other rather than affect the existing provider clinical psychologist, or clinical social requirements, as noted above. Other or supplier’s other enrollment. It is worker. Under certain conditions, an commenters expressed support for important to note that revocation FQHC visit may be furnished by a specific health care provider types that removes a provider or supplier’s qualified practitioner of outpatient are well suited to furnish MDPP enrollment in Medicare, not just its DSMT and medical nutrition therapy services. billing privileges for a particular (MNT) when the FQHC meets the A few commenters supported our Medicare service. For example, if a relevant program requirements for alternative proposal that existing hospital had an additional enrollment as provision of these services. RHC and Medicare providers and suppliers an MDPP supplier and one of their FQHC visits are medically-necessary separately enroll as MDPP suppliers and coaches was fraudulently reporting primary health services, and qualified be separately screened to be eligible to weight loss that beneficiaries did not preventive health services, that are bill for MDPP services. One commenter achieve, CMS would have the discretion

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to revoke the hospital’s MDPP supplier (§ 401.305), and procedures for or failing to move from preliminary to enrollment, but could withhold suspending, offsetting or recouping full recognition within 36 months of revocation of the hospital’s Part A Medicare payments in certain situations their effective date, or withdraws from Medicare enrollment. Alternatively, if (§ 405.371). As explained in more detail the CDC DPRP at any point, the CMS pursued the original proposal and in section III.J.7.c. of this final rule, we organization would be subject to the hospital did not reenroll as an will not be able to begin supplier revocation of its Medicare billing MDPP supplier, under the same enrollment until enforcement activities privileges for MDPP services as scenario, the hospital’s entire are finalized during subsequent provided by 42 CFR part 424, subpart P. enrollment could be revoked for up to rulemaking in 2017, but we encourage Under the CDC DPRP Standards, an three years, which could have DPP organizations to use this final rule organization that loses its CDC DPRP deleterious effects on the provision of to prepare for enrollment. This may recognition (and thus, under our care well beyond MDPP. For this reason, include working towards CDC proposal, would no longer be able to bill we are adopting our alternative recognition, as detailed in III.J.7.b. of Medicare for MDPP services) must wait proposal. this final rule, obtaining NPIs, or 12 months before reapplying for We acknowledge the concerns that obtaining claims processing software. recognition. We proposed that DPP requiring enrolled providers and The final policies for MDPP supplier organizations would be eligible to re- suppliers to separately enroll as an enrollment are set forth in § 424.59. enroll in Medicare as an MDPP supplier MDPP suppler imposes a burden. b. CDC DPRP Recognition if, after reapplying for CDC DPRP However, we disagree that enrollment recognition, the organization again screening for the purposes of one CDC grants pending recognition to an achieves preliminary recognition. supplier type would satisfy program organization upon its approval of the The following is a summary of the integrity concerns for a different organization’s application and the comments we received and our supplier type. Many program integrity organization’s agreement to comply responses. checks specifically target the licensure with requirements for use of a CDC- Comment: The majority of and credentials of a particular supplier approved curriculum and for duration commenters supported requiring DPP type that would not necessarily transfer and frequency of sessions. CDC also organizations to obtain CDC DPRP to other suppliers. Similarly, we establishes an effective date for each recognition in order to be eligible for disagree with commenters who stated approved organization which is the first enrollment in Medicare as an MDPP that the program integrity efforts and day of the month following their supplier. Some commenters regulations on providers or suppliers approval date. Organization must recommended we take into account the with an existing, non-MDPP enrollment submit data every 12 months from their socioeconomic status of participants in Medicare would sufficiently address effective date. CDC grants full when considering CDC’s recognition, any program integrity related concerns recognition after an organization with and work with CDC to account for the with regards to MDPP services. MDPP pending recognition has consistently risk of inadvertently precluding services and the manner in which those furnished sessions with a CDC-approved suppliers serving vulnerable services will be provided differ from curriculum, met CDC performance populations who have fewer resources other Medicare benefits and therefore standards, and met CDC reporting to achieve healthy eating and fitness require separate monitoring and requirements. CDC makes the first goals. Some commenters requested that regulation to ensure the program determination for full recognition 24 CMS allow MDPP supplier eligibility to integrity. months after their effective date. be based on alternative accreditations Final Decision: After consideration of Organizations not meeting full and standards focused on diabetes the public comments we received, we recognition at that time are reassessed at education. are finalizing our proposal to permit 36 months. Organizations that do not A few commenters noted that CDC organizations that meet the supplier achieve full recognition within 36 DPRP recognition is difficult to attain enrollment eligibility criteria to enroll months after their effective date will because it relies on average weight loss in Medicare as MDPP suppliers. We are lose any recognition and must wait 12 of 5 percent across the population of modifying our proposal with respect to months before reapplying. participants an organization serves, and existing Medicare providers or suppliers In our proposal regarding eligibility of if organizations fall a few decimal and requiring them to adhere to the DPP organizations to enroll in Medicare, points short of that threshold, they can same enrollment requirements as MDPP we proposed the use of an additional lose their recognition. Some suppliers if they wish to furnish and bill CDC recognition status: preliminary commenters expressed the concern that for MDPP services and otherwise meet recognition. beneficiary access may be disrupted if a the MDPP supplier enrollment We proposed that DPP organizations supplier falls short of CDC DPRP eligibility criteria. must have either preliminary or full Standards, therefore losing recognition We are finalizing the high screening CDC DPRP recognition in order to be and Medicare eligibility. Furthermore, level as proposed. We will continue to eligible to enroll in Medicare as MDPP commenters were concerned with the monitor enrollment efforts and program suppliers. We proposed that DPP timelines the CDC DPRP Standards integrity, and should our policy merit organizations can attain preliminary require for reapplication. Tribal adjustment, we may amend this CDC DPRP recognition upon meeting organizations collectively requested decision in future rulemaking as CDC DPRP performance standards and CDC DPRP recognition be automatically necessary. reporting requirements for 12 months granted to providers of the Special We are finalizing that MDPP suppliers after applying for recognition, and full Diabetes Program for Indians. are obligated to comply with all statutes recognition upon demonstrating Response: In response to comments and regulations that establish generally program effectiveness for 24–36 months regarding CDC recognition applicable requirements for Medicare after applying for CDC DPRP (socioeconomic status of participants, suppliers. These regulations include, recognition. We proposed that if an average weight loss requirement, but are not limited to, time limits for organization loses its CDC DPRP timelines with reapplication) we note filing claims (§ 424.44), requirements to recognition status at any point, for that CDC is responsible for developing report and return overpayments example for not meeting CDC standards standards related to CDC recognition,

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and we are not. We are coordinating recognition as an MDPP supplier. A confusion caused by the preliminary with CDC to promote alignment separate commenter suggested that CMS recognition standard and preserve between the CDC DPRP and MDPP clarify that to obtain preliminary program integrity. The commenter expanded model requirements, to the recognition, an organization must offer suggested that we should only pay extent possible. We are not considering the CDC-approved curriculum within 6 suppliers that have demonstrated their other accrediting bodies or at this time. months of the effective date of the effectiveness as MDPP suppliers or their We expect that the updated CDC DPRP organization’s CDC DPRP application ability to establish and maintain the Standards will be published for public and submit at least 6 months of necessary infrastructure. Another comment in 2017 and go into effect in participant data at 12 months post- commenter suggested that organizations 2018. effective date of the application. Several with full recognition be paid at a higher We welcome consultation with tribes commenters recommended removing rate than organizations with preliminary and tribal organizations as required by the requirement to submit one year’s recognition. the CMS Tribal Consultation Policy,27 worth of data before obtaining Several commenters recommended and will address this and other concerns preliminary recognition. that CMS adopt a grandfathering policy that have tribal implications, as One commenter noted that given the where organizations with 12 months of appropriate, in future rulemaking. work and time required for DPP data may obtain preliminary Comment: Several commenters organizations to start providing DPP recognition. A few commenters noted expressed support for the proposal that services, it may be difficult to obtain 12 that the creation of the preliminary organizations must obtain preliminary months of reporting data immediately recognition definition risks having few or full CDC DPRP recognition in order after the effective date of the DPP or no MDPP suppliers with preliminary to become eligible to enroll in Medicare organization’s pending recognition recognition by MDPP’s scheduled as an MDPP supplier. Other commenters status. The commenter expressed effective date of January 1, 2018, thus recommended that we clarify the concern that an organization that has delaying the implementation of MDPP. requirements for preliminary met the standards and reporting One commenter noted that the recognition and how preliminary requirements for 11 of the 12 months preliminary recognition status does not recognition differs from the CDC DPRP immediately following its application to exist in CDC DPRP Standards, and that Standards’ definition of pending participate in the DPRP should not have the preliminary recognition definition recognition. The commenters noted that to reapply for preliminary recognition would be published in CDC DPRP the CDC DPRP Standards currently do and start the 12-month process over Standards too late for MDPP suppliers not have a preliminary recognition again. Another commenter to begin enrolling into Medicare in time definition. A commenter recommended recommended that preliminary to begin furnishing MDPP services on that CDC be the entity responsible for recognition performance standards January 1, 2018. The commenter recognizing organizations with focus on percent of weight loss recommended that we require CDC to preliminary recognition, just as CDC is achieved, as opposed to average weight identify organizations with pending responsible for recognizing loss, and maintenance of weight loss recognition that qualify for preliminary organizations with pending recognition among participants. recognition no later than December 31, and full recognition. Some commenters recommended that 2016 and require that CDC release Several commenters recommended we allow organizations that have either interim guidance on standards or that CMS clarify which performance pending recognition or full recognition requirements for preliminary standards and reporting requirements from CDC to enroll as MDPP suppliers. recognition no later than March or April need to be met for 12 consecutive The commenters noted that 2017. The commenter notes that months to qualify for preliminary organizations obtain pending additional, minor clarifications may also recognition. The commenters noted that recognition from CDC after they agree to be needed when the CDC issues updated they assume that an MDPP supplier curriculum, duration, and intensity CDC DPRP Standards in January 2018 to would comply with the first year of CDC requirements. One commenter noted reflect early experience with the new DPRP Standards for pending recognition that the additional status of preliminary preliminary recognition definition. One status, starting at the effective date of recognition adds a complicated layer of commenter believed it should be the DPP organization’s pending bureaucracy to the existing CDC DPRP, permitted to enroll as an MDPP supplier recognition. The commenters also noted adds little value, and will likely delay because it has one year of data, even that this means submitting data at 12 enrollment of organizations in Medicare though it lacks CDC DPRP recognition. months from the effective date, but not as MDPP suppliers due to lack of Another commenter urged that we achieving any particular outcomes at 12 defined requirements for preliminary review its organization’s data before months because current CDC DPRP recognition. Several commenters 2018, and if it meets the standards for Standards do not consider outcomes for suggested that we allow participation of MDPP suppliers in 2017, that CMS achieving recognition until 24 months DPP organizations with pending reimburse the organization in 2017. from the effective date. Several recognition until CDC standards for Response: We appreciate the support commenters recommended that we preliminary recognition status are for our proposal to allow DPP clarify whether an organization must established. One commenter requested organizations with full CDC recognition, submit 6 months or one year of data to that we explain why we proposed an as well as certain DPP organizations that obtain preliminary recognition. The additional recognition status, whether do not yet have full CDC recognition, to commenters expressed their support we can create new CDC DPRP enroll as MDPP suppliers. We received that an organization offer DPP services recognition standards, and if so, how many comments that raised questions for at least a year before qualifying for the new recognition standards will be and concerns about preliminary CDC incorporated into the CDC DPRP recognition status or offer suggestions 27 Centers for Medicare & Medicaid Services, Standards. about how preliminary CDC recognition ‘‘CMS Tribal Consultation Policy,’’ Centers for One commenter recommended that status should be determined. Because Medicare & Medicaid Services, 2015, https:// www.cms.gov/Outreach-and-Education/American- only organizations with full CDC DPRP the CDC has not adopted standards for Indian-Alaska-Native/AIAN/Downloads/ recognition may serve as MDPP preliminary recognition, however, we CMSTribalConsultationPolicy2015.pdf. suppliers in order to eliminate potential are not finalizing any of our proposals

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with respect to preliminary recognition weight loss and participation, and recognition at this time. We intend to status at this time. Although we relative to those in pending status, few address this issue in future rulemaking. anticipate that CDC will address organizations have obtained full c. Coach Requirements standards for preliminary recognition recognition. However, we believe it is when it publishes updated DPRP important to ensure that prospective We proposed to require personnel Standards for public comment next MDPP suppliers have demonstrated who would furnish MDPP services, year, because any such standards for experience in actually furnishing DPP referred to hereafter as ‘‘coaches,’’ to CDC preliminary recognition would not services, and therefore we do not obtain a National Provider Identifier take effect until 2018, it will not be believe it is appropriate to permit (NPI) to help ensure the coaches meet possible to permit DPP organizations to organizations to enroll in Medicare CMS program integrity standards. We enroll in Medicare based on before they have submitted any also considered requiring that coaches achievement of CDC preliminary performance data to CDC that allows enroll in the Medicare program in recognition before then. CDC to assess their capacity to deliver addition to obtaining an NPI, and we For this reason, we intend to use DPP services. solicited comment on this approach. future rulemaking to propose interim We recognize the timing and nature of Another alternative policy we standards for preliminary recognition, our proposal has caused some considered was to require DPP under CMS authority, that would bridge confusion, particularly because we organizations to collect and submit the gap until CDC preliminary intend to use CDC recognition status as information on the coaches who would recognition standards are established. a Medicare enrollment standard. We furnish MDPP services, which could We anticipate that our proposed interim also agree with commenters that in include identifying information such as preliminary recognition standards general CDC should be responsible for first and last name and social security would be consistent with the principles recognizing DPP organizations, number (SSN). We proposed to require described in the proposed rule. We consistent with its recognition MDPP suppliers to submit the active intend to align our MDPP supplier standards. However, as noted above, we and valid NPIs of all coaches who enrollment policies with CDC intend to propose in future rulemaking would furnish MDPP services on behalf recognition standards, as appropriate, as interim CMS recognition standards that of the MDPP supplier through a roster they are established. We will take the would permit DPP organizations that are of coach identifying information. We commenters’ comments on preliminary seeking full CDC recognition and have proposed that if MDPP suppliers fail to recognition into account as we develop demonstrated capacity to furnish DPP provide active and valid NPIs of their our proposal for interim CMS services to enroll in Medicare prior to coaches, or if the coaches fail to obtain recognition standards. We do not intend January 1, 2018. We are considering or lose their active and valid NPIs, the to delay implementation of the MDPP performance criteria that we could MDPP supplier may be subject to expansion. propose as part of any interim CMS compliance action or revocation of We proposed that certain DPP standards that we would use to permit MDPP supplier status. organizations that had not yet achieved DPP organizations that have not yet The following is a summary of the full recognition could enroll in achieved full CDC recognition to enroll comments we received and our Medicare in acknowledgement that full as MDPP suppliers before the CDC responses. recognition might take 36 months and standards are updated. For example, we Comment: We received comments require achievement of certain are considering proposing that DPP regarding coach enrollment into performance standards. We proposed organizations with pending CDC Medicare. Commenters overwhelmingly this eligibility requirement for Medicare recognition would be required to meet stated objections to coach enrollment, enrollment to allow an increased a performance standard threshold of 60 citing reasons including high turnover number of organizations that have percent participant attendance in at and the reality that many coaches work demonstrated a capacity to provide DPP least 9 core sessions in months 1–6 and part time or as volunteers. Commenters services to enroll in Medicare, thereby 60 percent participant attendance in at also highlighted that since claims and allowing access to MDPP services in a least 3 core maintenance sessions in payment are handled directly by the timely manner as of January 1, 2018. We months 7–12. In addition, we intend to supplier, coaches have limited reasons continue to believe that it is appropriate consider options to ensure program to enroll. Other commenters noted that to permit enrollment in Medicare prior integrity and mitigate fraud and abuse coaches lack medical licensure, to achievement of full CDC recognition during the preliminary recognition indicating that only medical providers in cases where there is demonstrated stage. We encourage interested parties to should enroll. And several commenters capacity to furnish DPP services, and as submit comments on any updates to cited the burden that enrollment would noted above, we intend to address this CDC’s DPRP Standards when CDC impose on coaches, and that requiring issue in future rulemaking. Therefore, publishes them for public comment. this approach could limit coach we decline to permit DPP organizations Finally, in response to commenters, participation and ultimately reduce that have only pending recognition to we do not intend to propose differential beneficiary access to services. enroll in Medicare because such payments based on whether the supplier The majority of commenters indicated organizations may not have any has full recognition. We also do not that organizations alone should enroll in demonstrated capacity to furnish DPP intend to make payments for MDPP Medicare as MDPP suppliers, though services. We are aware that most DPP services prior to January 1, 2018. We one commenter proposed that diabetes organizations are currently in pending will also propose details on the payment prevention coordinators, who oversee recognition status, and that CDC’s structure in future rulemaking. the coaches as outlined in the CDC definition for pending recognition Final Decision: We finalize our DPRP Standards, should enroll. A few currently includes a 6-month grace proposal that an entity must have full commenters recommended that coaches period before organizations are required CDC DPRP recognition as a requirement enroll, stating that this would ensure to start offering DPP sessions. We are to enroll in Medicare as an MDPP our ability to protect the integrity of the also aware that the current definition of supplier. Due to timing issues with CDC Medicare program and have direct full recognition requires organizations standards updates, we are not finalizing oversight over coaches furnishing the to meet certain standards for average any proposals for preliminary benefit. Other commenters cited

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consistent use of CMS processes such as Commenters who opposed the work as a coach, these individuals enrollment for program integrity efforts requirement for coaches to obtain NPIs would be able to obtain an NPI on that rather than creating new processes. largely expressed that only health care basis for purposes of furnishing MDPP Several commenters highlighted the providers should obtain NPIs. Some services. opportunity for coaches to be directly commenters believed that MDPP Given the relatively low burden that paid for the services furnished. coaches do not meet the definition of obtaining NPIs places on coaches and Response: We agree with the health care provider under 45 CFR important considerations for commenters who stated that coaches 160.103, and therefore coaches should monitoring, evaluation, and program should not enroll in Medicare and not be allowed to obtain an NPI. Other integrity, we will require every coach should not be submitting MDPP claims. commenters questioned how coaches furnishing MDPP services on behalf of Though we understand there may be could obtain NPIs, particularly when an MDPP supplier to obtain an active program integrity advantages if coaches registered nurses (RNs) and other and valid NPI that will be submitted to were to enroll, we do not believe the credentialed professionals can neither Medicare on the supplier’s updated existing enrollment process is obtain NPIs nor enroll as Medicare roster of coaches. This roster of coach appropriate for coaches. Most notably, suppliers. Several commenters identifying information would be enrollment is for the purpose of recommended that CMS extend those submitted alongside the MDPP permitting Medicare billing, and we same proposals for coaches to RNs and supplier’s enrollment application to be have proposed that only MDPP other medical professionals who used for vetting and program integrity suppliers, not coaches, would submit currently lack the ability to obtain an purposes. However, we did not propose claims for MDPP services. We do not NPI. As an alternative to obtaining NPIs, specific standards for how we would believe coaches should have the ability a number of commenters proposed that use roster information in connection to submit claims for MDPP or be coaches should have specialized with MDPP supplier enrollment. We directly paid for the services furnished training. intend to propose such standards in because CDC DPRP recognition is Response: We did not propose any future rulemaking, and will begin obtained at the organization level, not requirements for diabetes prevention enrollment of MDPP suppliers once for the individual coach furnishing coordinators, but we may consider this appropriate standards are in place. Comment: We received general MDPP services. Additionally, we possibility for future rulemaking as support from commenters for the believe that the burden of enrolling and appropriate. Given that coaches directly furnish MDPP services, we believe that proposal to track coaches using some submitting claims, as well as the for any process aiming to track and form of identifiable information to help medical record retention requirements screen professionals working with an ensure the coaches meet CMS program associated with claim submissions, MDPP supplier, the coach will likely integrity standards. Few commenters would be too burdensome to place on stand as the most appropriate individual detailed in their response the type of individual coaches, and that suppliers to track and screen, as opposed to the information that should be collected. are more appropriate and suitable to coordinators who do not directly While some commenters preferred using assume this responsibility. We did not furnish MDPP services. coach names and NPIs for tracking propose enrolling diabetes prevention To commenters who did not believe purposes, slightly more commenters coordinators, but we believe the same that coaches would be eligible for an preferred using identifiable information rationale against requiring coaches to NPI, we note that 45 CFR part 162, such as social security numbers (SSNs). enroll would apply to these individuals subpart D specifies that health care Response: We appreciate the support as we did not propose that diabetes providers, as defined in 45 CFR 160.103, from commenters. Use of NPIs and SSNs prevention coordinators would be able may obtain NPIs. Among other things, a would serve different purposes in to bill for MDPP services. health care provider under 45 CFR vetting coaches against program Comment: We received many 160.103 is a person or organization who integrity risks upon the supplier’s comments regarding whether coaches furnishes health care in the normal enrollment in Medicare, as well as should obtain NPIs, with commenters course of business. Because 45 CFR evaluation and monitoring purposes for split on whether CMS should require 160.103 specifies that health care performance and continuing program only suppliers, or both suppliers and includes preventive services, we believe integrity efforts. In existing areas of coaches, to obtain NPIs. A few MDPP coaches provide health care and Medicare’s enrollment process where commenters alternatively suggested that are therefore health care providers both NPIs and SSNs are used for diabetes prevention coordinators, not under 45 CFR 160.103 and eligible to individual providers who enroll into coaches, would be more appropriately obtain NPIs. We disagree that requiring Medicare, SSNs serve the purposes of suited to obtain NPIs. Most commenters coaches to obtain NPIs would impose an completing background checks, while did not provide a reason for supporting undue burden on coaches, even those NPIs serve an identifying and tracking the proposal that coaches obtain an NPI, who work as coaches part-time or as purposes with regards to Medicare but those that did stated that having volunteers. Obtaining an NPI takes claims and actions. These two coaches obtain an NPI would serve to approximately 20 minutes and can be identifiers play distinct and important validate community health workers’ role done easily online. We will further roles in ensuring the integrity of in health care. Many commenters consider the impact of coach Medicare’s programs and the safety of expressed their support for coaches requirements for rural and tribal areas the beneficiaries served. Given obtaining an NPI as an alternative to that lack reliable access to the internet commenters’ openness to using both enrolling in Medicare. One commenter and will consider adjusting policies in pieces of identifying information, we indicated that given that MDPP services future rulemaking as appropriate. will finalize a requirement that MDPP will be additional preventive services, Requests for CMS to address NPI suppliers submit the names, NPIs and the processes that would apply to other issues and enrollment for other health SSNs of their coaches. additional preventive services should care providers such as RNs are outside Upon enrollment, MDPP suppliers also apply, and coaches who furnish of the scope of this rulemaking for must submit, and update within 30 days these services should therefore obtain MDPP. Should RNs or other providers of any changes, a roster of coaches, NPIs. who currently lack an NPI decide to including individuals’ first and last

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name, SSN and NPI to CMS along with While we received many comments and valid NPIs of all affiliated coaches its enrollment application to help suggesting additional requirements for and to update CMS within 30 days of a ensure the coaches meet CMS program coaches, a number of commenters also coach beginning to or ceasing to furnish integrity standards. Changes that must urged against adding additional MDPP services. We finalize that this be reported to us include adding requirements on coaches beyond CDC roster of coaches submitted will include identifying information for any coach DPRP Standards. the first and last name, SSN, and NPI. beginning to furnish MDPP services on Response: We do not, at this time, see We intend to propose policies specific behalf of the supplier or removing a any need to require additional training, to enrollment standards and coach who ceases furnishing MDPP certification, or clinician oversight or enforcement actions, as they relate to services on behalf of the supplier. We affiliation beyond the CDC DPRP the roster, in future rulemaking. intend to address how this coach Standards, particularly given that the The final policies for coach information might affect MDPP supplier initial DPP model test met the criteria requirements are set forth in § 424.59. for expansion without these enrollment and be used in enforcement d. Revocation of MDPP Supplier requirements. actions in future rulemaking as Enrollment appropriate. As noted previously, Though we agree that CDEs, RNs, and enrollment of MDPP suppliers will not other credentialed professions can be We proposed that all MDPP suppliers begin until such standards are in place. effective MDPP coaches, the DPP model would be required to comply with the Comment: We received a number of test showed that trained, non- requirements of 42 CFR part 424. If an comments on coach requirements under credentialed coaches can effectively MDPP supplier has its Medicare the MDPP expanded model. The deliver the program. Additionally, we enrollment revoked or deactivated for majority of commenters stated that do not believe that the literature reasons unrelated to its loss of CDC training should be required, some supports this claim that coaches with DPRP recognition, that MDPP supplier stipulating that specific trainers should credentials would result in better would lose its ability to bill Medicare be utilized. Within the discussion of participant performance than non- for MDPP services but would not training, some commenters stipulated credentialed individuals trained to be automatically lose its CDC DPRP that medical professionals should be coaches.28 29 30 31 Therefore, we do not recognition. We proposed that existing exempt from any additional training believe credentials are necessary at this Medicare providers and suppliers who imposed on coaches, while others time, but may evaluate and revisit this lose CDC DPRP recognition would lose stipulated that everyone—including proposal as necessary. Therefore, any their Medicare billing privileges with medical professionals—should undergo individuals—with or without respect to MDPP services, but may training to become a coach. One credentials—can become a coach continue to bill for other non-MDPP commenter recommended that CMS provided that they meet CDC DPRP Medicare services for which they are create an audit process to ensure that Standards and work for a MDPP eligible to bill. We proposed that MDPP training occurred. Several commenters supplier. suppliers that have their Medicare urged us to consider creating a We will further consider commenters’ billing privileges revoked or that lose certification program for coaches. suggestions regarding mechanisms to billing privileges for MDPP may appeal Commenters also referred to the CDC ensure that coaches have received high these decisions in accordance with the DPRP Standards for coach requirements quality training, whether we will procedures specified in 42 CFR part and requested that CMS clarify whether require coach certification, the impact 405, subpart H, 42 CFR part 424, and 42 formal lifestyle coaching is a credentials may have on coaches, and CFR part 498. We proposed to add a requirement and specifically what the possibility of clinician affiliation or new § 424.59 to our regulations to constitutes the definition of trained oversight as we monitor and evaluate specify the suppliers who would be coach to furnish the required the expanded model. eligible for Medicare enrollment and curriculum. Other commenters asked Final Decision: We are finalizing the billing for MDPP services. We solicited whether we will require additional proposal that DPP organizations must comment on these proposals. training sources or continuing education enroll in Medicare to become MDPP The following is a summary of the requirements above the CDC DPRP suppliers, and that coaches will not comments we received regarding these Standards in order to qualify as a coach. enroll in Medicare for purposes of proposals and our responses. Many commenters supported specific furnishing MDPP services. We are Comment: A few commenters agreed practitioners to serve as coaches, such finalizing the proposal that coaches with the proposal that loss of CDC DPRP as Certified Diabetes Educators (CDEs). must obtain NPIs. We are requiring recognition should lead to loss of MDPP Other commenters recommended that MDPP suppliers to submit the active billing privileges. Some commenters coaches should have clinician oversight. specifically agreed that revocation Similarly, other commenters suggested 28 D Vojta et al., ‘‘A Coordinated National Model should be limited to MDPP privileges. that we require for coaches to have for Diabetes Prevention: Linking Health Systems to Commenters also stated that the ability clinicians as affiliates who can serve as an Evidence-Based Community Program,’’ to appeal a revocation decision was American Journal of Preventive Medicine 44, no. 4 important. One commenter expressed a medical resource. A few commenters Suppl 4 (2013): S301–S306. stated that coaches should have some 29 Mohammed K. Ali et al., ‘‘How Effective were concerns that losing Medicare billing form of credentials, particularly given Lifestyle Interventions in Real-World Settings that privileges would affect MDPP suppliers that participants may have medical were Modeled on the Diabetes Prevention less than medical professionals, questions about weight loss that extend Program?,’’ Health Affairs 31, no.1 (2012): 67–75. presenting a potential vulnerability to beyond a CDC-approved curriculum, 30 L Ruggiero et al., ‘‘Community-Based fraud. For medical professionals, Translation of the Diabetes Prevention Program’s which credentialed professionals are Lifestyle Intervention in an Underserved Latino Medicare provides a key source of better equipped to handle. A number of Population,’’ The Diabetes EDUCATOR 37, no. 4 income and livelihood, whereas non- commenters specifically requested that (2011); 564–572. traditional Medicare providers who we recognize the value that CDEs can 31 JA Katula et al., ‘‘The Healthy Living primarily deliver non-health care Partnerships to Prevent Diabetes Study 2-Year have in the MDPP expanded model and Outcomes of a Randomized Controlled Trial,’’ related services like those in a specify the role that they play in the American Journal of Preventive Medicine 44, no. community center would not management of lifestyle changes. 4S4 (2013): S324 –S332. necessarily be as affected by a

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revocation than a health clinic. The effectiveness of virtual sessions informative public comments suggesting commenter did not suggest an furnished remotely. We proposed to matters related to furnishing virtual alternative approach that could make allow MDPP suppliers to furnish MDPP services, various modes of furnishing losing Medicare billing more impactful services through remote technologies. virtual services, how effective these for these organizations. As part of our evaluation of the MDPP services are, and that the standards that Response: We appreciate the support expansion, to the extent feasible, we apply to in-person sessions may not be from commenters on our proposed planned to evaluate the effectiveness of applicable to virtual sessions. revocation policies, including the right MDPP services, particularly in relation Commenters were overwhelmingly to appeal a revocation. Should we deny to virtual versus in-person services, and, supportive of the proposal to allow a prospective MDPP supplier’s using the evaluation data, modify or virtual providers to participate, enrollment, we expect that appeal rights terminate this component of the particularly to ensure adequate access to set forth in 42 CFR part 424 would expansion as appropriate. To permit the benefit in underserved areas. Only apply, however we will address any such evaluation, we are considering one commenter noted that in-person provisions related to Medicare specifying the nature of the virtual services should be prioritized over enrollment denial appeal rights in service and the site of the service in virtual services. Commenters provided future rulemaking. We agree with codes included on claims submitted for specific suggestions on how to mitigate commenters that should a supplier lose payment, as well as collecting fraud and abuse and evaluate these CDC DPRP recognition, the supplier’s information on the nature of the virtual services by using site of service codes revocation would be only of the service and the site of service at the on claims, and requiring technology supplier’s MDPP enrollment. We beneficiary level from MDPP suppliers. based methods for weight loss reporting disagree that revocation of MDPP We planned to monitor administrative (for example, digital scales) versus self- enrollment would affect existing claims for virtual services to identify reported methods. providers and suppliers less than new any unusual and/or adverse utilization Response: We appreciate the MDPP suppliers. In both cases, the of the MDPP services. We solicited comments on the virtual furnishing of supplier would lose its ability to bill for comment on specific monitoring MDPP services. We noticed many MDPP services. We reiterate that all activities or program integrity differences between the way a virtual MDPP suppliers—whether a new safeguards with respect to virtual MDPP supplier and in-person supplier Medicare supplier or a currently services, in addition to the time period may operate, in addition to hybrid enrolled provider and supplier—must in which such enhanced monitoring virtual and in-person programs. We do comply with the requirements of 42 CFR activities should occur. not have enough information to finalize part 424, subpart P, including, but not We noted that MDPP services this proposal at this time, but expect to limited to, enrollment bars. CMS notes provided via a telecommunications continue gathering more information on that we did not propose a policy system or other remote technology will the virtual delivery of DPP services. We regarding the effective date of the not be part of current Medicare appreciate the many insights and revocation, and will do so in future telehealth benefits and have no impact comments we received, particularly rulemaking. We retain the authority to on how telehealth services are defined suggestions of strategies to maintain revoke any Medicare enrollment— by Medicare. We recognize that the program integrity. We remain MDPP supplier or otherwise—if a provision of MDPP services by such committed to including virtual supplier does not comply with Medicare virtual methods may introduce providers and services in MDPP as soon requirements. additional risks for fraud and abuse, and as possible, but we intend to use future Final Decision: We are finalizing our we plan to address specific policies in rulemaking to address detailed policies proposals that all MDPP suppliers must future rulemaking to mitigate these on virtual providers’ eligibility to enroll, comply with the requirements of 42 CFR risks. We thus solicited comment on furnish and bill for MDPP services. part 424, will have their MDPP supplier whether there are quality or program f. Information Technology (IT) enrollment revoked upon loss of CDC integrity concerns regarding the use of Infrastructure and Capabilities DPRP recognition or noncompliance virtual sessions, or whether they offer with Medicare requirements, and may comparable or higher quality MDPP We proposed that in order to receive appeal these decisions in accordance services when compared to in-person payment, MDPP suppliers would be with the procedures specified in 42 CFR services. We solicited comment on required to submit claims to Medicare part 405, subpart H, 42 CFR part 424, strategies to strengthen program using standard claims forms and and 42 CFR part 498. integrity and minimize the potential for procedures. Claims would be submitted The final revocation and appeal fraud and abuse in virtual sessions. in batches that contain beneficiary policies are set forth in § 424.59. The following is a summary of the Protected Health Information (PHI) and comments we received regarding these Personally Identifiable Information (PII), e. Virtual MDPP Services proposals and our responses. including the Health Insurance Claim Currently, CDC-recognized DPP Comment: In response to our Number (HICN). Most Medicare claims organizations deliver DPP services in- proposals for virtual MDPP services, we are submitted electronically except in person or virtually via a received many insightful and limited situations. We provide a free telecommunications system or other software package called PC–ACE Pro32 remote technology. The majority of Weight Loss into Primary Care: a Randomized that creates a patient database and current DPP organizations furnish DPP Trial,’’ JAMA Internal Medicine 173, no. 2 (2013): allows organizations to electronically 113–121. services in-person, but an emerging 34 submit claims to Medicare Part A and B. 32 33 34 35 CS Sepah et al., ‘‘Translating the Diabetes body of literature supports the Prevention Program into an Online Social Network: We understand there are several other Validation Against CDC Standards,’’ The Diabetes electronic claims submissions software 32 W Su et al., ‘‘Return on Investment for Digital Educator 40, no. 4 (2014): 435–443. packages available in the market for Behavioral Counseling in Patients With Prediabetes 35 Y Fukuoka et al., ‘‘A Novel Diabetes Prevention purchase. We encouraged current and and Cardiovascular Disease,’’ Preventive Chronic Intervention Using a Mobile App: A Randomized Disease 13, no. E13 (2016). Controlled Trial with Overweight Adults at Risk,’’ prospective DPP organizations to 33 J Ma et al., ‘‘Translating the Diabetes American Journal of Preventive Medicine [serial investigate adopting these systems to Prevention Program Lifestyle Intervention for online] 49, no. 2 (2015): 223–237. enhance the efficiency of claims

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submission, and we sought comment on medical record would require proof of related to the MDPP services furnished the capacity of DPP organizations to lab work or if documentation of the to the beneficiary, in compliance with integrate these systems into their values would suffice. One commenter HIPAA and other applicable privacy workflows. We indicated that we would noted that while beneficiaries’ data laws, and CMS standards, such as provide guidance to MDPP suppliers should be held in an EHR, suppliers documentation of the beneficiary’s regarding the Medicare claims should be able to transfer this eligibility, including blood test results, submission standards. information in electronic, paper, or fax sessions attended, the coach furnishing We proposed to require MDPP format to beneficiaries’ other providers. the session(s) attended, the date and suppliers to maintain a crosswalk Though commenters generally agreed location of service(s), and weight. We between the beneficiary identifiers they with the recordkeeping requirements, understand various forms of submit to CMS for billing purposes and including the duration of recordkeeping, documentation exist depending on the the beneficiary identifiers they provide many of these same commenters and type of blood test administered, and we CDC for beneficiary level-clinical data. others noted the burden that will provide additional details on what We proposed that MDPP suppliers recordkeeping requirements might specific records are required to provide this crosswalk to the CMS impose on community-based demonstrate eligibility in future evaluator on a regular basis. organizations. These commenters urged guidance and/or future rulemaking as We proposed that MDPP suppliers us to consider the implications that a appropriate. In response to commenters’ maintain records that contain detailed high cost, HIPAA-compliant questions on the format of these records, documentation of the services furnished recordkeeping system might impose on we encourage the use of electronic to beneficiaries, including but not such organizations, as well as the records, but do not require it for limited to the beneficiary’s eligibility subsequent strain it would place on purposes of this expanded model. status, sessions attended, the coach beneficiary access should the Further details on specific information furnishing the session attended, the date requirement be cost prohibitive. that would qualify as auditable and place of service of sessions Additionally, a number of commenters documentation of the supplier’s record attended, and weight. We proposed that urged that when making IT-related will be provided in guidance and/or MDPP suppliers maintain these records policy decisions, that we consider the future rulemaking as appropriate. within a larger medical record, or lack of internet and issues with Although we require entities to within a medical record that an MDPP electricity in rural and tribal areas. maintain these records for the purposes supplier establishes for the purposes of These commenters suggested of auditing, medical reviews, or other administering MDPP. Consistent with clarifying the medical record CMS requests, we do not intend to the requirement in § 424.516(f) we requirement in such a way that would require that suppliers submit additional proposed that these records be retained be economically feasible for data, outside what is on the claim, to for 7 years from the date of service and community-based programs. Due to CMS for the purpose of payment. that MDPP suppliers would provide these concerns, a number of CMS or a Medicare contractor access to commenters suggested that we work Although we understand it might be these records upon request. We with CDC or other entities to identify a easier for suppliers to submit claims and proposed to require MDPP suppliers to low cost data and billing system. Other performance data to one joint CMS–CDC accurately track payments and resolve commenters went further to suggest that data system, we believe that any discrepancies between claims and CMS work with CDC to streamline the maintaining MDPP claims independent the beneficiary record within their two data reporting systems such that from CDC performance data would medical record. We also proposed that when coaches or suppliers input allow us to compare information MDPP suppliers would be required to performance data on beneficiary submitted to CMS with those submitted maintain and handle any beneficiary PII sessions to CDC, the Medicare claim to CDC to identify inconsistencies, as and PHI in compliance with the Health would automatically be generated. supported by certain commenters. Insurance Portability and Others appreciated the reliance on Additionally, it is important to note that Accountability Act of 1996 (HIPAA), existing claim forms and software and while all MDPP suppliers will be other applicable privacy laws, and CMS applauded CMS for not creating a new organizations that have CDC standards. We indicated that we would data submission system. A few recognition, it is likely that not all provide education and guidance to commenters noted that given the cost organizations with CDC recognition will MDPP suppliers to mitigate the risk of burdens of adequate IT, data, and enroll in Medicare. Similarly, not all data discrepancies and audits. We stated recordkeeping systems, many participants in the National DPP are that we would address specific community-based programs are likely to Medicare beneficiaries. Thus, Medicare recordkeeping requirements and use third party integrators. These claims information will not be relevant standards in future rulemaking as commenters did not advocate for a to CDC’s assessment of performance appropriate. specific role for these integrators. One data. For the aforementioned reasons, The following is a summary of the commenter, however, requested that we do not agree with commenters that comments we received and our MDPP suppliers be permitted to partner a joint CDC–CMS data system would be responses. with and use the IT system of a appropriate. We appreciate that these Comment: Several commenters healthcare entity to maintain records recordkeeping requirements can impose recommended CMS clarify what the and submit claims for Medicare burdens on MDPP suppliers, medical record should include, whether payment. Lastly, one commenter particularly those who have not the medical record should be paper or suggested that MDPP suppliers be previously had to comply with these electronic, and whether suppliers required to take HIPAA-compliant types of recordkeeping requirements. should retain records of any referrals training due to concerns about non- While MDPP suppliers are responsible and diagnostic tests demonstrating medical professionals housing HIPAA- for complying with these requirements, beneficiary eligibility or simply compliant information. MDPP suppliers can decide which document that one was presented at the Response: We wish to clarify that for resources to utilize in order to do so, time of enrollment. Commenters purposes of MDPP, the medical record including the use of a third party requested guidance on whether the would need to contain information administrator or other entity.

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Comment: Several commenters noted format, whether or not CMS would MDPP, as well as provide any necessary the current proposed requirements for provide a template, the frequency with documents during an audit, medical recordkeeping do not apply to the which suppliers would be required to review, or other CMS request. The nature of sessions furnished virtually. submit the same data to CMS, and the crosswalk therefore has a role both with One commenter proposed alternative need for the crosswalk to CDC data program integrity purposes as well as record keeping requirements that were given that CMS is requiring all suppliers for evaluating the expanded model’s consistent with the proposal, but would to retain records for auditing purposes, effectiveness, as required of any allow flexibility for suppliers who medical reviews, or other requests. Innovation Center model. We intend to furnish MDPP services through virtual Response: We understand the desire provide guidance to suppliers on how to technologies. to avoid undue burdens on MDPP set up the crosswalk, and make any Response: We are deferring all further adjustments or clarifications (for decisions regarding virtual providers to suppliers. We intend for the crosswalk to alleviate the redundancy for suppliers example, frequency of submissions) in future rulemaking as discussed in future rulemaking, as appropriate. section III.J.7.e. of this final rule. submitting performance data to CMS that is already being sent to CDC. Since Final Decision: We are finalizing as Comment: Numerous commenters proposed the documentation retention agreed with the proposal that MDPP MDPP is an expanded model test, we are required to evaluate the requirements and requirements for suppliers maintain a crosswalk between suppliers to provide documents in the beneficiary identifiers submitted to CMS effectiveness of the MDPP expansion, and this crosswalk will facilitate this case of an audit, medical review, or for billing and beneficiary identifiers other CMS request. The final policies submitted to CDC for beneficiary-level evaluation. While we understand the are set forth in § 424.59. clinical data. A few commenters recommendation to create the crosswalk disagreed, stating CMS and CDC should directly with CDC, the CDC does not 8. Policies for Future Rulemaking receive any personal identifying not impose this requirement on a. MDPP Reimbursement Structure suppliers and should instead coordinate information (PII) on beneficiaries who directly to alleviate further reporting participate in the National DPP that We proposed to reimburse for MDPP requirements for MDPP suppliers. would enable CMS and CDC to directly services at the times and in the amounts Regarding monitoring and program create the beneficiary crosswalk. While set forth in the Table 41, with payment integrity comments, we received general we are requiring organizations to retain tied to the number of sessions attended support for this approach to compare records for CMS-directed audits, a and achievement of a minimum weight CMS claims with CDC performance crosswalk between CMS and CDC data loss of 5 percent of baseline weight data. Several commenters requested will enable CMS to conduct an (body weight recorded during the further clarity on the crosswalk, its evaluation on the effectiveness of beneficiary’s first core session).

TABLE 41—MDPP EXPANSION PAYMENT MODEL

Payment per beneficiary (non-cumulative)

Core Sessions

1 Session attended ...... $25 4 Sessions attended ...... $50 9 Sessions attended ...... $100 Achievement of minimum weight loss of 5% from baseline weight ...... $160

Achievement of advanced weight loss of 9% from baseline weight ...... $25 (in addition to $160 above)

Maximum Total for Core Sessions ...... $360

Core Maintenance Sessions (Maximum of 6 monthly sessions over 6 months in Year 1)

3 Core Maintenance Sessions attended (with maintenance of minimum required weight loss from baseline) ...... $45 6 Core Maintenance Sessions attended (with maintenance of minimum required weight loss from baseline) ...... $45

Maximum Total for Maintenance Sessions ...... $90

Maximum Total for First Year ...... $450

Ongoing Maintenance Sessions After Year 1 (Minimum of 3 sessions attended per quarter/no maximum)

3 Ongoing Maintenance Sessions attended plus maintenance of minimum required weight loss from baseline ...... $45 6 Ongoing Maintenance Sessions attended plus maintenance of minimum required weight loss from baseline ...... $45 9 Ongoing Maintenance Sessions attended plus maintenance of minimum required weight loss from baseline ...... $45 12 Ongoing Maintenance Sessions attended plus maintenance of minimum required weight loss from baseline ...... $45

Maximum Total After First Year ...... $180

As proposed, Table 41 illustrates that toward achievement of weight loss over payments would be available after the payments would be heavily weighted the 12-month core benefit, and no first 6 months without achievement of

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the minimum weight loss. In the suppliers would be subject to audits and Organizations Final Rule (76 FR 67802) payment structure we proposed, claims reviews performed by CMS program (November 2011 final rule)). A for payment would be submitted integrity and/or review or audit subsequent major update to the program following the achievement of core contractors in addition to program- rules appeared in the June 9, 2015 session attendance, minimum weight specific audits. We sought comment on Federal Register (Medicare Shared loss, maintenance (both core and these approaches and others to mitigate Savings Program; Accountable Care ongoing) session attendance, and these risks and strategies to ensure Organizations Final Rule (80 FR 32692) maintenance of minimum weight loss. program integrity. (June 2015 final rule)). A final rule For example, MDPP suppliers would In response to our solicitation, we addressing changes related to the not be able to submit another claim after received many comments. We intend to program’s financial benchmark core session one until the beneficiary address these comments in future methodology appeared in the June 10, has completed four sessions, and rulemaking. 2016 Federal Register (Medicare maintenance sessions (both core and Program; Medicare Shared Savings c. Learning Activities ongoing) would not qualify for payment Program; Accountable Care unless minimum weight loss was The CDC provides technical Organizations—Revised Benchmark achieved and maintained. Similar value- assistance to DPP organizations with Rebasing Methodology, Facilitating based payments are being offered by CDC DPRP recognition to improve Transition to Performance-Based Risk, commercial insurers and accepted by performance. We solicited comment on and Administrative Finality of Financial DPP organizations. We sought comment what additional technical assistance Calculations (81 FR 37950) (June 2016 on this payment structure. Additionally, would be needed for providers and final rule)). As noted below, we have we sought comment on whether to other organizations in order to expand also made use of the annual PFS rules update payment rates annually through the MDPP model. to address quality reporting and certain an existing fee schedule, such as the In response to our solicitation, we other issues. PFS, or establish a new fee schedule for received many insightful and Additionally, on April 27, 2016, the MDPP suppliers. informative public comments and will Department of Health and Human We are deferring finalizing the consider the input when developing our Services (HHS) issued a proposed rule proposed reimbursement structure to strategy for ensuring that organizations to implement key provisions of the future rulemaking. In response to our seeking to enroll in Medicare and Medicare Access and CHIP solicitation, we received many furnish and bill for MDPP services have Reauthorization Act of 2015 (MACRA) comments. We intend to address these the information and guidance they need and establish a new Quality Payment comments in future rulemaking. to do so. Program (QPP) (Medicare Program; Merit-Based Incentive Payment System b. Program Integrity d. Quality Monitoring and Reporting (MIPS) and Alternative Payment Model We recognize the potential for fraud We solicited comment on the quality (APM) Incentive under the Physician and abuse by suppliers filing inaccurate metrics that should be reported by Fee Schedule, and Criteria for claims and/or duplicative claims on the MDPP suppliers in addition to the Physician-Focused Payment Models (81 number of sessions attended or amount reporting elements required on FR 28162) (QPP proposed rule)). On of weight loss achieved. We also Medicare claims submissions outlined October 14, 2016, HHS issued a final recognize beneficiaries may move above (attendance and weight loss) or by rule to implement key provisions of the between MDPP suppliers, and we the CDC DPRP. We solicited comment MACRA and establish a new QPP (QPP intend to address in future rulemaking specifically on what quality metrics final rule with comment period). (The as appropriate any requirements should be considered for public rule will appear in the November 4, necessary to prevent duplication claims reporting (not for payment) to guide 2016 Federal Register, and can be for MDPP services furnished by more beneficiary choice of MDPP suppliers. accessed at https://qpp.cms.gov/ than one MDPP supplier to the same In response to our solicitation, we education.) The QPP final rule with beneficiary. We are also concerned received many comments. We intend to comment period establishes a new about the potential for beneficiary address these comments in future program under which Medicare will inducement or coercion and the rulemaking. reward physicians for providing high- potential program risks posed by K. Medicare Shared Savings Program quality care, instead of paying them permitting a new type of organization to only for the number of tests or receive payment from Medicare for Under section 1899 of the Act, we procedures provided. The QPP final rule furnishing MDPP services. We also established the Medicare Shared with comment period addresses issues realize that there may be other risks to Savings Program (Shared Savings related to APMs, such as Tracks 1, 2, program integrity. We intend to develop Program) to facilitate coordination and and 3 of the Medicare Shared Savings policies to mitigate these risks and cooperation among providers to Program, and issues related to reporting monitor the MDPP expansion, to ensure improve the quality of care for Medicare for purposes of MIPS by eligible MDPP suppliers meet all applicable Fee-For-Service (FFS) beneficiaries and clinicians (ECs) that are participating in CMS program integrity and supplier reduce the rate of growth in health care APMs. enrollment standards, and will address costs. Eligible groups of providers and Our intent in the CY 2017 PFS them in future rulemaking, as necessary. suppliers, including physicians, proposed rule was to propose further We intend to develop system checks to hospitals, and other health care refinements to the Shared Savings identify when CMS may need to audit providers, may participate in the Shared Program rules, and we identified several an MDPP supplier’s records. We are Savings Program by forming or policies that we proposed to update or considering ways to cross reference the participating in an Accountable Care revise. First, we discussed and proposed data DPP organizations are currently Organization (ACO). The final rule policies related to ACO quality required to report to the CDC to identify establishing the Shared Savings Program reporting including proposed changes to potential discrepancies with data appeared in the November 2, 2011 the quality measures used to assess ACO submitted to CMS. We sought comment Federal Register (Medicare Shared quality performance, changes in the on such approaches. Finally, MDPP Savings Program: Accountable Care methodology used in our quality

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validation audits and the way in which FR 74757 through 74764; 79 FR 67907 Systems (CG–CAHPS) survey. The the results of these audits may affect an through 67931; and 80 FR 71263 measures collected through the CMS ACO’s sharing rate, various issues through 712710), we have established web interface are also used to determine related to alignment with policies the quality performance standard that whether eligible professionals proposed in the QPP proposed rule, and ACOs must meet to be eligible to share participating in an ACO avoid the PQRS revisions related to the terminology in savings that are generated. Through and automatic Physician Value Modifier used in quality assessment such as these previous rulemakings, we have (VM) payment adjustments for 2015 and ‘‘quality performance standard’’ and worked to improve the alignment of subsequent years. Currently, eligible ‘‘minimum attainment level.’’ We also quality performance measures, professionals billing through the TIN of proposed conforming changes to our submission methods, and incentives an ACO participant may avoid the regulatory text. Next, we addressed under the Shared Savings Program and downward PQRS payment adjustment several issues unrelated to quality PQRS. when the ACO satisfactorily reports all reporting and assessment. Specifically, In the CY 2017 PFS proposed rule, we of the ACO GPRO measures on their we proposed to implement a process by proposed several changes and other behalf using the CMS web interface. which beneficiaries may voluntarily revisions to our policies related to the Beginning with the 2017 VM, ACO align with an ACO by designating an quality measures and the quality performance on the CMS web interface ACO professional as responsible for performance standard, including the measures and all cause readmission their overall care. We also proposed to following: measure will be used in calculating the introduce beneficiary protections • Changes to the measure set used in quality component of the VM for groups related to use of the SNF 3-day rule establishing the quality performance and solo practitioners participating waiver. Finally, we proposed to make standard; within an ACO (79 FR 67941 through technical changes and updates to certain • Changes to the methodology used to 67947). rules related to merged and acquired validate quality data submitted by the In the CY 2017 PFS proposed rule, we TINs and the minimum savings rate ACO along with penalties that may explained that our principal goal and (MSR) and minimum loss rate (MLR) apply if the audit match rate is less than rationale for selecting quality measures that would be used during financial 90 percent; for ACOs has been to identify measures reconciliation for ACOs that fall below • Revisions to the use of the terms of success in the delivery of high-quality 5,000 assigned beneficiaries. ‘‘quality performance standard’’ and health care at the individual and population levels with a focus on 1. ACO Quality Reporting ‘‘minimum attainment level’’ in the regulation text; outcomes and a preference for NQF- Section 1899(b)(3)(A) of the Act • Revisions related to use of flat endorsed measures. We noted, however, requires the Secretary to determine percentages to establish quality that the statute does not limit us to appropriate measures to assess the benchmarks; and using endorsed measures in the Shared quality of care furnished by ACOs, such • Alignment with policies proposed Savings Program. As a result, we have as measures of clinical processes and in the QPP proposed rule. also exercised our discretion to include outcomes; patient, and, wherever certain measures that we believe to be practicable, caregiver experience of care; a. Changes to the Quality Measure Set high impact but that are not currently and utilization such as rates of hospital Used in Establishing the Quality endorsed, including for example, admission for ambulatory sensitive Performance Standard ACO#11, which is currently titled conditions. Section 1899(b)(3)(B) of the (1) Background Percent of PCPs Who Successfully Meet Act requires ACOs to submit data in a Meaningful Use Requirements. form and manner specified by the Section 1899(b)(3)(C) of the Act states Further, we described our continuing Secretary on measures that the Secretary that the Secretary shall establish quality work with the measures community to determines necessary for ACOs to report performance standards to assess the ensure that the specifications for the to evaluate the quality of care furnished quality of care furnished by ACOs and measures used under the Shared by ACOs. Section 1899(b)(3)(C) of the seek to improve the quality of care Savings Program are up-to-date and Act requires the Secretary to establish furnished by ACOs over time by reduce reporting burden. Importantly, quality performance standards to assess specifying higher standards, new we noted that the Core Quality the quality of care furnished by ACOs, measures, or both. In the November Measures Collaborative was formed in and to seek to improve the quality of 2011 final rule, we established a quality 2014, as a collaboration between CMS, care furnished by ACOs over time by performance standard consisting of 33 providers, and other stakeholders, with specifying higher standards, new measures across four domains, the goal of aligning quality measures for measures, or both for the purposes of including patient experience of care, reporting across public and private assessing the quality of care. care coordination/patient safety, stakeholders in order to reduce provider Additionally, section 1899(b)(3)(D) of preventive health, and at-risk reporting burden. On February 16, 2016, the Act gives the Secretary authority to population. In subsequent PFS final the Core Quality Measures Collaborative incorporate reporting requirements and rules with comment period, we have recommended a core quality measure incentive payments related to the PQRS, made a number of updates to the set of set that aligns and simplifies quality EHR Incentive Program and other measures that make up the quality reporting across multiple payers similar initiatives under section 1848 of performance standard. The quality (https://www.cms.gov/Newsroom/ the Act. Finally, section 1899(d)(1)(A) of measure set currently includes 34 MediaReleaseDatabase/Press-releases/ the Act states that an ACO is eligible to quality measures. 2016-Press-releases-items/2016-02- receive payment for shared savings, if Quality measures are submitted by the 16.html) and made specific they are generated, only after meeting ACO through the CMS web interface, recommendations for ACOs (https:// the quality performance standards calculated by CMS from administrative www.cms.gov/Medicare/Quality- established by the Secretary. and claims data, and collected via a Initiatives-Patient-Assessment- In the November 2011 final rule and patient experience of care survey based Instruments/QualityMeasures/ recent CY PFS final rules with comment on the Clinician and Group Consumer Downloads/ACO-and-PCMH-Primary- period (77 FR 69301 through 69304; 78 Assessment of Healthcare Providers and Care-Measures.pdf). We proposed to

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integrate several recommendations to align with the QPP proposals, we should remain pay for reporting for all made by the Core Quality Measures therefore proposed to replace the 3 performance years. Collaborative into the CMS web Documentation of Current Medications As we stated in the CY 2017 PFS interface as part of the QPP proposed in the Medical Record measure (ACO– proposed rule, by aligning the Shared rule (81 FR 28399). These 39) by reintroducing Medication Savings Program measures with the recommendations were subsequently Reconciliation (ACO–12) in the Care Core Quality Measures Collaborative adopted in full in the QPP final rule Coordination/Patient Safety domain. We recommendations and proposals under with comment period. Groups that are noted that in accordance with our the QPP proposed rule, we hope to eligible to report using the CMS web policy for newly introduced measures, reduce the burden of provider data interface for purposes of reporting this measure would be pay for reporting collection and reporting of measures quality measures to CMS for various for 2 years and proposed that it would that do not align across public and quality reporting initiatives such as phase into pay for performance in private quality reporting initiatives. PQRS and the Shared Savings Program accordance with the schedule indicated Therefore, we proposed to retire or replace the following measures in order are required to report on all measures in Table 36 of the proposed rule (81 FR to reduce provider reporting burden by included in the CMS web interface. In 46421–46422). reducing the number of measures that addition, for purposes of the QPP, we • proposed and finalized a policy ACO–44 Use of Imaging Studies for must be reported and because these requiring that groups using the CMS Low Back Pain (NQF #0052). Imaging measures do not align with the core web interface must report on all utilization is an important area for measure set recommendations from the measures in the CMS web interface. quality measurement, because of the Core Quality Measures Collaborative wide use of imaging services. This and the measures that we proposed for (2) Proposals measure reports the percentage of reporting through the CMS web In efforts to continue to align with patients with a primary diagnosis of low interface in the QPP proposed rule: other CMS initiatives and reduce back pain that did not have an imaging • ACO–39 Documentation of Current provider confusion and the burden of study (for example, MRI, CT scan) Medications in the Medical Record. reporting, we proposed modifications to within 28 days of the diagnosis. (A • ACO–21 Preventive Care and the quality measure set that an ACO is higher score indicates higher Screening: Screening for High Blood required to report. Specifically, to align performance). The Use of Imaging Pressure and Follow-up Documented. • the Shared Savings Program quality Studies for Low Back Pain quality ACO–31 Heart Failure (HF): Beta- measure set with the measures measure is specified for patients 18–50 Blocker Therapy for Left Ventricular recommended by the Core Quality Systolic Dysfunction (LVSD). years of age. We proposed adding this • Measures Collaborative and proposed measure in the Care Coordination/ ACO–33 Angiotensin-Converting for reporting through the CMS web Patient Safety domain to address a gap Enzyme (ACE) Inhibitor or Angiotensin interface under the QPP proposed rule, in measures related to resource Receptor Blocker (ARB) Therapy—for we proposed to add, and in some cases utilization and align with the ACO patients with CAD and Diabetes or Left to replace, existing quality measures measures recommended by the Core Ventricular Systolic Dysfunction (LVEF<40%). with the following: Quality Measures Collaborative core • In addition to our proposals above to ACO–12 Medication Reconciliation measure set (https://www.cms.gov/ modify the quality measure set to align Post-Discharge (NQF #0097). This Medicare/Quality-Initiatives-Patient- measure addresses adverse drug events with the Core Quality Measures Assessment-Instruments/ Collaborative and the proposed (ADEs) through medication QualityMeasures/Downloads/ACO-and- reconciliation, which is an important modifications to the measures reported PCMH-Primary-Care-Measures.pdf). We through the CMS web interface under aspect of care coordination. According noted that the measure was also to HHS’ Agency for Healthcare Research the QPP proposed rule, we proposed a proposed in the QPP proposed rule for few additional modifications as follows: and Quality (AHRQ), ADEs account for measuring the quality of care furnished nearly 700,000 emergency department First, we proposed to retire the two by individual and specialty ECs (81 FR AHRQ Ambulatory Sensitive Conditions visits and 100,000 hospitalizations each 28399 and 28460 Tables A and E). In the year.36 The ACO–12 Medication Admission measures (ACO–9 and ACO– QPP final rule with comment period, we 10). Although ACO–9 and ACO–10 Reconciliation measure was previously adopted the low back pain measure for in the Shared Savings Program measure address admissions for patients with EHR reporting. Under the Shared heart failure, chronic obstructive set, however, it was replaced with Savings Program, we proposed that this ACO–39, Documentation of Current pulmonary disease (COPD), and asthma, measure would be calculated using we introduced two all-cause, unplanned Medications in the Medical Record (79 Medicare claims data without any FR 67912 through 67914). The Core admission measures for heart failure additional provider reporting and multiple chronic conditions (ACO– Quality Measures Collaborative, in requirement. We noted that in coordination with providers and 37 and ACO–38, respectively) in the accordance with our policy for newly 2015 PFS final rule (79 FR 67911– stakeholders, determined the original introduced measures, this measure Medication Reconciliation measure 67912). We believe ACO–37 and ACO– would be designated as pay for 38 report on a similar population with would be more appropriate for reporting in 2017 and 2018. We alignment across quality reporting similar conditions as ACO–9 and ACO– proposed to phase it into pay for initiatives. Based on this 10. Therefore, in order to continue our performance in accordance with the recommendation, we proposed to efforts to reduce redundancies within schedule indicated in Table 36 of the require reporting of the measure through the Shared Savings Program measure proposed rule (81 FR 46421–46422). the CMS web interface in the QPP set, we proposed to remove ACO–9 and However, given the possible small case proposed rule (81 FR 28403). In an effort ACO–10 from the measure set. sizes due to the measure specifications, Second, although we proposed to we specifically solicited comment on remove ACO–9 and ACO–10, we stated 36 ‘‘Medication Errors.’’ AHRQ. https:// psnet.ahrq.gov/primers/primer/23/medication- whether this measure should be phased that we continue to believe AHRQ’s errors. in to pay for performance or whether it Prevention Quality Indicator (PQI)

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measures are important because they notes on its Web site, NQF #0554 order to reduce provider reporting report on inpatient hospital admissions measure is no longer endorsed, because burden and align with the Core Quality of patients with clinical conditions the measure developer, NCQA, Measures Collaborative recommended (such as dehydration, bacterial determined the measure is outdated and core set and the measures that will be pneumonia, and urinary tract infections) withdrew the measure from reported for purposes of the QPP. that could potentially be prevented with endorsement. Although readmissions Comment: Most commenters agreed high-quality outpatient care. We could be counted as a new index that ACO–44 Use of Imaging Studies for therefore proposed adding ACO–43 discharge based on the measure Low Back Pain is an important quality Ambulatory Sensitive Condition Acute specifications, it is important that measure and supported addition of this Composite (AHRQ PQI #91) to the Care providers coordinate care and engage in measure. However, concerns were Coordination/Patient Safety domain. We medication reconciliation following raised regarding the measure noted that this measure is a composite each hospital discharge, whether it be specifications. Some commenters were measure, currently used in the an initial admission or subsequent concerned about the narrow age range of Physician Value-Based Payment readmission. ACO–12 also maintains this measure and potentially small case Modifier, which includes PQIs reporting alignment with quality reporting under sizes that could result from the age on admissions related to dehydration, the QPP. Given that ACO–12 aligns with range being limited to adults aged 18– bacterial pneumonia, and urinary tract the QPP and is an NQF endorsed 50. These commenters made various infections (PQIs #10, 11, and 12). We measure that is recommended by the suggestions for modification of our noted the measure would be risk- Core Quality Measures Collaborative, proposal such as using a broader age adjusted for demographic variables and we are finalizing our proposal to replace range or making the measure pay for comorbidities. In accordance with our ACO–39 with ACO–12. In accordance reporting for all years. While some policy for newly introduced measures, with our policy for newly introduced commenters appreciated that the use of we proposed that this measure would be measures, we are also finalizing our claims data to calculate this measure pay for reporting for 2 years, and then proposal that this measure will be pay would avoid unnecessary administrative phase into pay for performance in for reporting for 2 years, and then phase burden on providers, one commenter accordance with the schedule indicated into pay for performance in accordance was concerned about relying solely on in Table 36 of the proposed rule (81 FR with the schedule as proposed in Table claims data without incorporating 46421–46422). 36 of the proposed rule (81 FR 46421– clinical data from the medical record Comment: Commenters were 46422). and suggested that the measure be pay generally supportive of the proposed Comment: Several commenters for reporting until CMS has the capacity changes to the Shared Savings Program specifically supported the removal of to incorporate robust clinical data. A quality measure set. Most commenters ACO–21 Screening for High Blood few commenters opposed the addition supported alignment of quality Pressure and Follow-up Documented, of ACO–44, stating they believe it is measures with Core Quality Measures ACO–31 Beta-Blocker Therapy for inappropriate for a Medicare ACO’s Collaborative recommendations. LVSD, and ACO–33 ACE Inhibitor or patient population, given the measure Response: We appreciate the support ARB Therapy—for patients with CAD specification’s limited age range. One for proposed changes to the Shared and Diabetes or Left Ventricular Systolic commenter on ACO–44 asked whether Savings Program quality measure set Dysfunction (LVEF<40%) in the interest plain film radiographs would be and for aligning with the of harmonization, even though the included as an imaging modality for the recommendations of the Core Quality measures do include an important measure. Measures Collaborative. follow-up component. One commenter Response: We agree with commenters The following is a summary of the raised concerns about removing ACO– that support the proposal to include comments we received on specific 21 because it has a follow-up ACO–44 Use of Imaging Studies for Low proposed changes to the quality component they believe is particularly Back Pain because it addresses a measure set: important for women with heart disease. clinically important gap in quality Comment: Regarding our proposal to Response: We appreciate the measurement and aligns with the reinstate use of ACO–12 Medication commenter support we received for recommendations made by the Core Reconciliation and remove ACO–39 removing these measures. To the extent Quality Measures Collaborative. We also Documentation of Current Medications that commenters noted the importance agree with commenters’ concerns in the Medical Record, one commenter of certain aspects of these measures, we regarding the narrow age range (18–50 suggested that using ACO–12 acknowledge that these measures years of age) under the measure Medication Reconciliation would be a address important health issues. Many specifications, which could result in better means to improve population quality measures that are not part of the small case sizes if limited to Medicare health. One commenter expressed ACO quality measure set address beneficiaries assigned to the ACO. With concern over reintroducing ACO–12 various important health issues for respect to the comment that raised a since it counts a readmission within 30 patients. However, it is not feasible for concern about relying solely on claims days as a new index discharge for the us to include all measures that address data to calculate the measure, we agree measure and suggested using NQF important health issues in the quality that additional clinical data could #0554 Medication Reconciliation Post- measure set for the Shared Savings possibly enhance the measure. Discharge instead. Program. Rather, we must choose However, using additional clinical data Response: We appreciate the measures based upon a consideration of would require additional reporting by comments submitted on our proposal to the importance of the measures for the the ACO. At this time, we do not believe reinstate ACO–12 Medication patient population served by ACOs, the it is appropriate to impose this Reconciliation, including the comment reporting burden placed on ACOs and additional reporting burden, and suggesting the measure would be a their participants, and the extent to therefore, we will not be adopting the better means to improve population which measures align with other quality commenter’s suggestion. In response to health. While one commenter suggested reporting initiatives. Accordingly, we the commenter that asked whether plain using NQF #0554 Medication are finalizing our proposal to retire film radiographs would be included in Reconciliation Post-Discharge, as NQF ACO–21, ACO–31, and ACO–33 in the measure specifications, we note that

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the current NQF endorsed measure set recommendations. One commenter initiatives, we believe it is appropriate specifies the use of plain x-ray, MRI, suggested quarterly feedback support for to include ACO #43 in the ACO quality and CT scan. Although we are finalizing this measure and other commenters measure set. our proposal to add this measure to the suggested this measure be pay for Comment: We received several quality measure set, in light of the reporting for all performance years in an additional comments regarding the concerns raised regarding the age range ACO’s agreement period so ACOs can quality measure set that were not and potential for small case sizes, we become more familiar with the measure directly related to our proposals. A few are modifying the proposed timeline for for their own operations. Some commenters suggested CMS risk adjust transitioning the measure to pay for commenters raised concerns with the the claims-based quality measures to performance. In accordance with our use of the measure at the ACO-level account for socioeconomic factors. policy for newly introduced measures, when AHRQ developed the measure at Several commenters stated their support this measure will be pay for reporting the population level. for retaining the Influenza and for 2 years. However, rather than Response: We appreciate commenters’ Pneumonia vaccination measures phasing in the measure as pay for support for our proposal to add ACO– (ACO–14 and ACO–15). We also performance, we are finalizing a policy 43 to the ACO quality measure set. We received quality measure suggestions for under which the measure will remain as are finalizing its addition to the ACO future consideration, such as additional pay for reporting for all the 3 quality measure set because it addresses immunization and transitions of care performance years of an ACO’s important clinical conditions that could measures. agreement period. potentially be prevented with Response: We appreciate the support Comment: Some commenters coordinated, high-quality outpatient supported the proposal to retire ACO– for measures that are currently included care. Although some commenters 9 because patients with COPD are in the quality measure set. We also suggested maintaining the measure as already assessed under ACO–38 All- thank commenters for their other pay for reporting all 3 years of an ACO’s Cause Unplanned Admissions for recommendations regarding quality agreement period, we believe ACOs will Patients with Multiple Chronic reporting under the Shared Savings have sufficient opportunity to become Conditions (MCC). In addition, Program. We will keep these suggestions familiar with the measure because, in commenters supported CMS’ proposal and comments in mind for future accordance with the timeline for to retire ACO–10, because the quality consideration. introducing new measures under measure set already includes an all- Final Action: We appreciate the cause admission measure for patients § 425.502(a)(4), it will be pay for thoughtful comments submitted in with Heart Failure (ACO–37). Some reporting for 2 years before transitioning response to our proposed changes to the commenters urged CMS to retain ACO– to pay for performance under the phase- quality measure set. We are finalizing 9 or consider other COPD-related in schedule indicated in Table 36 of the the measure set changes (deletions, measures for future reporting due to the proposed rule (81 FR 46421–46422). At additions, and replacement) as proposed prevalence of mortality-related COPD. A this time, we do not anticipate for the reasons noted in our responses commenter suggested that the Core providing quarterly quality measure above and to align with the Core Quality Quality Measures Collaborative consider updates, because we only calculate the Measures Collaborative and the COPD-related measures to include in measure annually; however, we will measures that were finalized in the QPP their core measure set continue to consider whether it would final rule with comment period. We recommendations. be feasible to do so. Further, we believe note that in light of comments received Response: We appreciate the it is appropriate to use this measure at on ACO–44 Use of Imaging Studies for comments supporting our proposal to the ACO-level to assess ACO Low Back Pain and its potential for low retire ACO–9 and ACO–10. We agree performance. ACOs are required to case sizes, we will add this measure as that COPD and heart failure affect a improve the quality and cost of the care proposed but will retain it as pay for large volume of beneficiaries and are of the fee-for-service patient population reporting in all 3 years of the ACO’s clinically important areas for quality assigned to them. In order to be eligible agreement period. All other measures measurement. However, we note that for participation in the Shared Savings will be phased in as proposed. COPD and heart failure are among the Program, the ACO must have at least Table 42 lists the Shared Savings chronic conditions addressed by the 5,000 assigned beneficiaries. We Program quality measure set that will be specifications for ACO–38 and ACO–37, therefore believe an ACO’s patient used to assess quality performance respectively. Therefore the patient population is sufficiently large enough starting with the 2017 performance year populations for the measures are that it is appropriate to apply this including the new measures adopted in similar, and we agree with commenters measure at the ACO-level. Additionally, this final rule. Each measure that is who noted that the measures are ACO–43 is used in and aligns with other indicated as a new measure will be redundant. As a result, we are finalizing CMS quality initiatives; it is currently assessed as a pay for reporting measure our proposal to remove ACO–9 and reported for purposes of the Physician for the 2017 and 2018 performance ACO–10 from the ACO quality measure Value-Modifier and has been used for years. After that, the measure will be set. We also appreciate the additional assessing physician performance and assessed based on the phase-in schedule COPD measure recommendations and was finalized as an informational noted in Table 42. will consider them for future reporting. measure under the QPP final rule with As a result of these proposed measure Comment: Most commenters comment period. We have an changes, the four domains will include supported the proposal to add ACO–43 overarching belief in the importance of the following number of quality Ambulatory Sensitive Condition Acute collecting information regarding the measures (See Table 43 for details.): Composite to the measure set. prevalence of preventable conditions • Commenters also appreciated our and readmissions and providing this Patient/Caregiver Experience of proposal that the measure would be information to clinicians to assist them Care–8 measures initially introduced as pay for reporting in developing targeted care • Care Coordination/Patient Safety– because it was not included in the Core improvement processes. To support this 10 measures Quality Measure Collaborative measure goal and to align with other CMS quality • Preventive Health–8 measures

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• At Risk Population–5 measures (3 Table 43 provides a summary of the will be used for scoring purposes under individual measures and a 2-component number of measures by domain and the the changes to the quality measure set diabetes composite measure) total points and domain weights that adopted in this final rule. TABLE 42—MEASURES FOR USE IN THE ESTABLISHING QUALITY PERFORMANCE STANDARD THAT ACOS MUST MEET FOR SHARED SAVINGS STARTING WITH THE 2017 PERFORMANCE YEAR

Pay for performance NQF phase in Domain ACO measure Measure title New measure #/measure Method of data R—reporting # steward submission P—performance PY1 PY2 PY3

AIM: Better Care for Individuals

Patient/Caregiver Experience .. ACO–1 ...... CAHPS: Getting Timely Care, ...... NQF #0005 Survey ...... R P P Appointments, and Informa- AHRQ. tion. ACO–2 ...... CAHPS: How Well Your Pro- ...... NQF #0005 Survey ...... R P P viders Communicate.37 AHRQ. ACO–3 ...... CAHPS: Patients’ Rating of ...... NQF #0005 Survey ...... R P P Provider.2 AHRQ. ACO–4 ...... CAHPS: Access to Specialists ...... NQF #N/A Survey ...... R P P CMS/AHRQ. ACO–5 ...... CAHPS: Health Promotion and ...... NQF #N/A Survey ...... R P P Education. CMS/AHRQ. ACO–6 ...... CAHPS: Shared Decision Mak- ...... NQF #N/A Survey ...... R P P ing. CMS/AHRQ. ACO–7 ...... CAHPS: Health Status/Func- ...... NQF #N/A Survey ...... R R R tional Status. CMS/AHRQ. ACO–34 ...... CAHPS: Stewardship of Patient ...... NQF #N/A Survey ...... R P P Resources. CMS/AHRQ. Care Coordination/P Patient ACO–8 ...... Risk-Standardized, All Condi- ...... Adapted NQF Claims ...... R R P Safety. tion Readmission. #1789 CMS. ACO–35 ...... Skilled Nursing Facility 30-Day ...... Adapted NQF Claims ...... R R P All-Cause Readmission #2510 CMS. Measure (SNFRM). ACO–36 ...... All-Cause Unplanned Admis- ...... NQF#TBD Claims ...... R R P sions for Patients with Diabe- CMS. tes. ACO–37 ...... All-Cause Unplanned Admis- ...... NQF#TBD Claims ...... R R P sions for Patients with Heart CMS. Failure. ACO–38 ...... All-Cause Unplanned Admis- ...... NQF#TBD Claims ...... R R P sions for Patients with Mul- CMS. tiple Chronic Conditions. ACO–43 ...... Ambulatory Sensitive Condition X AHRQ ...... Claims ...... R P P Acute Composite (AHRQ Prevention Quality Indicator (PQI) #91). ACO–11 ...... Use of certified EHR tech- X NQF #N/A As finalized R P P nology. CMS. under the QPP. ACO–12 ...... Medication Reconciliation Post- X NQF #0097 CMS Web R P P Discharge. CMS. Interface. ACO–13 ...... Falls: Screening for Future Fall ...... NQF #0101 CMS Web R P P Risk. NCQA. Interface. ACO–44 ...... Use of Imaging Studies for Low X NQF #0052 Claims ...... R R R Back Pain. NCQA.

AIM: Better Health for Populations

Preventive Health...... ACO–14 ...... Preventive Care and Screen- ...... NQF #0041 CMS Web R P P ing: Influenza Immunization. AMA–PCPI. Interface. ACO–15 ...... Pneumonia Vaccination Status ...... NQF #0043 CMS Web R P P for Older Adults. NCQA. Interface. ACO–16 ...... Preventive Care and Screen- ...... NQF #0421 CMS Web R P P ing: Body Mass Index (BMI) CMS. Interface. Screening and Follow Up. ACO–17 ...... Preventive Care and Screen- ...... NQF #0028 CMS Web R P P ing: Tobacco Use: Screening AMA–PCPI. Interface. and Cessation Intervention. ACO–18 ...... Preventive Care and Screen- ...... NQF #0418 CMS Web R P P ing: Screening for Clinical CMS. Interface. Depression and Follow-up Plan. ACO–19 ...... Colorectal Cancer Screening ...... NQF #0034 CMS Web R R P NCQA. Interface. ACO–20 ...... Breast Cancer Screening ...... NQF #2372 CMS Web R R P NCQA. Interface. ACO–42 ...... Statin Therapy for the Preven- ...... NQF #N/A CMS Web R R R tion and Treatment of Car- CMS. Interface. diovascular Disease.

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TABLE 42—MEASURES FOR USE IN THE ESTABLISHING QUALITY PERFORMANCE STANDARD THAT ACOS MUST MEET FOR SHARED SAVINGS STARTING WITH THE 2017 PERFORMANCE YEAR—Continued

Pay for performance NQF phase in Domain ACO measure Measure title New measure #/measure Method of data R—reporting # steward submission P—performance PY1 PY2 PY3

Clinical Care for At Risk Popu- ACO–40 ...... Depression Remission at ...... NQF #0710 CMS Web R R R lation—Depression. Twelve Months. MNCM. Interface. Clinical Care for At Risk Popu- ACO–27 ...... Diabetes Composite (All or ...... NQF #0059 CMS Web R P P lation—Diabetes. Nothing Scoring): ACO–27: NCQA (indi- Interface. Diabetes Mellitus: Hemo- vidual com- globin A1c Poor Control. ponent). ACO–41 ...... ACO–41: Diabetes: Eye Exam ...... NQF #0055 CMS Web R P P NCQA (indi- Interface. vidual component). Clinical Care for At Risk Popu- ACO–28 ...... Hypertension (HTN): Control- ...... NQF #0018 CMS Web R P P lation—Hypertension. ling High Blood Pressure. NCQA. Interface. Clinical Care for At Risk Popu- ACO–30 ...... Ischemic Vascular Disease ...... NQF #0068 CMS Web R P P lation—Ischemic Vascular (IVD): Use of Aspirin or An- NCQA. Interface. Disease. other Antithrombotic.

TABLE 43—NUMBER OF MEASURES AND TOTAL POINTS FOR EACH DOMAIN WITHIN THE QUALITY PERFORMANCE STANDARD STARTING WITH THE 2017 PERFORMANCE YEAR

Number of Domain individual Total measures for scoring purposes Total possible Domain weight measures points (percent)

Patient/Caregiver Experience ...... 8 8 individual survey module measures ...... 16 25 Care Coordination/Patient Safety...... 10 10 measures, including double-weighted 22 25 EHR measure. Preventive Health ...... 8 8 measures ...... 16 25 At-Risk Population ...... 5 3 individual measures, plus a 2-component 8 25 diabetes composite measure that is scored as one measure.

Total in all Domains ...... 31 30 ...... 62 100

b. Improving the Process Used To the medical record documentation As we explained in the proposed rule, Validate ACO Quality Data Reporting supports what was reported (that is, a since publication of the initial program (1) Background match). If all records reviewed support rules in 2011, we have gained what was reported, the audit ends. If experience in conducting audits and In the November 2011 final rule, we any records do not support what was finalized a proposal to retain the right believe that certain modifications to our reported (that is, a mismatch), the audit rules should be made in order to to validate the data ACOs enter into the process continues in a second phase for Web Interface (76 FR 67893 through increase the statistical rigor of the audit any measure with a mismatch methodology, streamline audit 67894). This validation process, referred identified. to as the Quality Measures Validation operations, and more closely align the • Phase 2: The remaining 22 medical audit, was based on the process used in Quality Measures Validation audit used records are reviewed for any measure Phase I of the Physician Group Practice in Shared Savings Program audits with that had a mismatch identified in Phase (PGP) demonstration. The policy was other CMS quality program audits 1. If less than 90 percent of the medical finalized at § 425.500(e). In this audit including those performed in the records provided for a measure support process, CMS selects a subset of Web Physician Quality Reporting Program what was reported, the audit process Interface measures, and selects a and the Hospital Inpatient and continues to Phase 3. random sample of 30 confirmed and Outpatient Quality Reporting programs. • Phase 3: For each measure with a completely reported beneficiaries for We therefore proposed four match rate less than 90 percent, CMS each measure in the subset. The ACO improvements to our audit process that provides education to the ACO about provides medical records to support the how to correct reporting and the ACO is would address the number of records to data reported in the Web Interface for given an opportunity to resubmit the be reviewed per measure, the number of those beneficiaries. A measure-specific measure(s) in question. audit phases, the calculation of an audit audit performance rate is then If at the conclusion of the third phase match rate and the consequences if the calculated using a multi-phased audit audit match rate falls below 90 percent. process: there is a discrepancy greater than 10 • Phase 1: Eight randomly selected percent between the quality data (2) Proposals medical records for each audited reported and the medical records measure are reviewed to determine if provided during the audit, the ACO will First, we proposed to increase the not be given credit for meeting the number of records audited per measure 37 The quality measure title has been updated to quality target for any measure(s) for to achieve a high level of confidence ‘‘Providers’’ and is not only referencing ‘‘Doctors.’’ which the mismatch rate exists. that the true audit match rate is within

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5 percentage points of the calculated believed that this single step process the ACO’s performance on each result. The November 2011 final rule would allow us to maintain the desired measure, we explained that we believe indicated that CMS would review as few level of confidence that the true audit a modification to this requirement as 8 records (Phase 1 only) or as many match rate is within 5 percentage points would be necessary to reflect an overall as 30 records (Phase 1 and 2) per of the calculated result and to complete adjustment. Therefore, we proposed to audited measure. With this phased the audit in a timely manner. Therefore, modify the provision at newly methodology, the total number of we proposed to remove the provision at redesignated § 425.500(e)(2) to state that records reviewed for each ACO varies § 425.500(e)(2) that requires 3 phases of if an ACO fails the audit (that is, has an (range of 40 to 150 records per audited medical record review. In so doing, we audit match rate of less than 90 ACO during the Performance Year 2014 proposed to redesignate § 425.500(e)(3) percent), the ACO’s overall quality score audit). A sample size analysis found as § 425.500(e)(2). will be adjusted proportional to the that the number of reviewed records Third, we proposed to revise the ACO’s audit performance. The audit- needs to increase in order to provide the redesignated provision at § 425.500(e)(2) adjusted quality score would be desired high level of confidence that the in order to provide for an assessment of calculated by multiplying the ACO’s audited sample is representative of the the ACO’s overall audit match rate overall quality score by the ACO’s audit ACO’s quality reporting performance. across all measures, instead of assessing match rate. For example, if an ACO’s We noted that the precise number of the ACO’s audit mismatch rate at the quality score is 75 percent and the records requested for review would measure level. Specifically, we ACO’s audit match rate is 80 percent, necessarily vary, depending on the proposed to calculate an overall audit the ACO’s audit-adjusted quality score desired confidence level, the number of match rate which would be derived by would be 60 percent. The audit-adjusted measures audited, and the expected dividing the total number of audited quality score would be the quality score match rate. Therefore, we did not records that match the information that is used to determine the percentage propose a specific number of records reported in the Web Interface by the of any earned savings that the ACO may that would be requested for purposes of total number of records audited. This share or the percentage of any losses for ACO quality validation audits in the would be a change from the current which the ACO is accountable. future. However, based on an analysis audit performance calculation Finally, we proposed to add a new using the poorest expected match rate, methodology, which calculates a requirement at § 425.500(e)(3) that in the highest degree of confidence and an measure specific mismatch rate. We addition to the adjustment to the ACO’s estimated number of measures to be stated that we believe making this overall quality score, any ACO that has audited, we explained we did not change would be necessary to minimize an audit match rate of less than 90 anticipate more than 50 records would the number of records that must be percent, may be required to submit a be requested per audited measure. requested in order to achieve the corrective action plan (CAP) under desired level of statistical certainty as § 425.216 for CMS approval. In the CAP, Second, we proposed to modify our described in the first proposal discussed the ACO may be required to explain the regulations in order to conduct the in this section. Our analysis suggests cause of its audit performance and how quality validation audit in a single step that we would have to request a much it plans to improve the accuracy of its rather than the current multi-phased larger number of records (approximately quality reporting in the future. In process described at § 425.500(e)(2). We 200 per measure) from the ACO during addition, we explained that CMS proposed to use a more streamlined a quality validation audit of individual maintains the right, as described in approach in which all records selected measures to achieve a 90 percent § 425.500(f), to terminate or impose for audit would be reviewed in a single confidence interval for each measure. In other sanctions on any ACO that does step and some activities currently addition, combining all records to not report quality data accurately, conducted in phase 3 would be removed calculate an overall audit match rate is completely or timely. from the audit process entirely while less subject to variability based on the We invited comment on the proposed others would instead be addressed at specific subset of measures chosen for improvements to the process used to the conclusion of the audit. During the audit each year and better aligns with validate ACO quality data reporting. proposed single step, we stated we the methodology used by other CMS The following is a summary of the would review all submitted medical quality program audits. comments we received regarding the records and calculate the match rate. We Fourth, we proposed to revise the proposed improvements to the process anticipated that the education we redesignated provision at used to validate ACO quality data currently provide to ACOs and the § 425.500(e)(2), to indicate that if an reporting. opportunity for ACOs to explain the ACO fails the audit (that is, has an Comment: Most commenters mismatches that occur in Phase 3 of the overall audit match rate of less than 90 supported our proposals to improve and current process would continue, but percent), the ACO’s overall quality score better streamline the process for would occur at the conclusion of the would be adjusted proportional to its validating the accuracy of data reported audit. We stated that under the audit performance. Currently, our through the CMS web interface and to proposal, there would not be an the regulation at § 425.500(e)(3) states that use audit results to adjust the ACO’s opportunity for ACOs to correct and if, at the conclusion of the audit process overall quality performance score. Few resubmit data for any measure with a there is a discrepancy greater than 10 commenters opposed the proposed >10 percent mismatch because we have percent between the quality data changes to the audit because they like learned through our experience with reported and the medical records the current process that includes program operations that resubmission of provided, the ACO will not be given multiple phases of review and is CMS Web Interface measure data after credit for meeting the quality target for focused on performance on specific the close of the CMS Web Interface is any measures for which this mismatch measures. Some commenters raised not feasible. Instead, we proposed that rate exists. In light of our proposed general concerns regarding the an ACO’s quality score would be modifications to the quality validation administrative burden for ACOs and affected by an audit failure as described audit process above in which we providers and suppliers who are below, without requiring re-opening of proposed to assess and validate the selected for the audit and must submit the CMS Web Interface. We stated we ACO’s performance overall rather than records for review. A couple of

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commenters recommended delaying Comment: Some commenters to employ some discretion related to the implementation of the new process until requested more information on the adjustment of an ACO’s overall quality a single web interface measures number of measures that would be score. For example, an ACO may have information document is available or to selected for the audit or suggested that experienced an error when reporting allow ACOs additional time to adjust to ACOs have an opportunity to correct measures electronically (for example, an the proposed changes to the process for and resubmit data during the audit error in mapping the extensible markup conducting the quality validation process. Some commenters suggested language (XML) specifications) that audits. CMS include an appeal process, because affects all beneficiaries reported on for Response: We agree with commenters of the audit’s potential impact on an a quality measure. In this instance, a on the importance of validating the ACO’s overall quality score and on the mapping error could be out of the accuracy of data reported through the calculation of shared savings. A few control of the ACO that, based on an web interface. The accuracy of the commenters pointed out there is a audit, demonstrated that it had reported data is important because it is difference between ACOs selected for otherwise fulfilled our quality reporting used by us to conduct certain activities, audit due to data anomalies and those requirements. In the absence of such as determining shared savings and that are selected randomly and that flexibility not to apply an adjustment to shared losses. The data is also made these groups should be treated the ACO’s overall quality score, such an available to the public, and we differently. One commenter noted that ACO may be unfairly penalized. understand that ACOs and ACO innocent mistakes can be made by those Therefore, we are modifying our providers/suppliers may use it to make uploading data to CMS systems and that proposed policy. Specifically, we are business decisions while beneficiaries rather than penalizing the ACO there finalizing a policy under which CMS may rely on it to determine whether to should be an opportunity for the ACO will adjust an ACO’s overall work care from practitioners to correct such mistakes. Additionally, performance score to reflect audit participating in an ACO. We believe the while some commenters agreed with the findings when the ACO has an audit proposed streamlined approach to 90 percent match rate, others mismatch rate of greater than 10 quality validation audits will minimize recommended using a lower confidence percent. However, we will retain administrative burden associated with interval. discretion not to apply this adjustment the audit for both ACOs and CMS Response: To streamline the process, to the ACO’s score in certain unusual because it reduces the multiple phases we proposed to have a single process circumstances where it would be of documentation submission with a single audit step, regardless of inappropriate to apply the adjustment. contemplated under the existing process the reason an ACO is selected for the We note that we do not intend to to a single phase of supporting audit. The proposals were intended to employ this discretion to avoid documentation submission. streamline the audit process, provide adjusting an ACO’s overall performance Additionally, we appreciate audit feedback to ACOs and validate the score in instances when the ACO cannot stakeholder input on our operational accuracy of quality data in a timely produce adequate validation of the data documents, such as the suggestion to manner that, in turn, permits timely submitted or did not interpret the create a single guidance document that feedback and allows accurate measure specifications correctly. For addresses the specifications for and information to be used in the example, if we determine that the ACO requirements of web interface measures reconciliation of the ACO’s performance has not produced medical record reporting. Currently, educational for the prior year. Incorporating an information sufficient to validate the materials about web interface measures appeals process would severely delay data the ACO submitted to the web are found in several documents. In ACO reconciliation, and therefore, we interface, we would not exercise our response to earlier requests for the do not agree that such a process should discretion not to apply the adjustment creation of a single document, we have be included. Additionally, we believe to the ACO’s overall performance score been working closely with our that establishing an appeals process based on results of the audit. We believe colleagues who are responsible for the would be inconsistent with the statutory it is reasonable to: (1) Hold ACOs CMS web interface to develop preclusion on administrative and accountable for the accuracy of the data educational documents that would judicial review of the assessment of the submitted according to information they streamline the information available to quality of care furnished by the ACO validate from medical record reviews; all web interface reporters, including under section 1899(g) of the Act. and (2) require ACOs to produce proof ACOs. We intend to continue to work to Nevertheless, we are sympathetic to of such accuracy in the event of an improve these communications and comments noting that simple mistakes audit. Also, if we determine that the materials to assist ACOs in their can be made when reporting quality ACO did not interpret the measure preparation for quality measures that, if given the opportunity to be specifications correctly, we would apply submission. However, we believe that rectified, would not reflect poorly on the adjustment to the ACO’s overall information currently available to the actual quality of the care delivered performance based on audit results ACOs, in addition to the support we by the ACO. We note, however, that the because ACOs are provided numerous provide through our help desks, CMS web interface provides a number opportunities to receive assistance from webinars, and other methods of of reports that ACOs can access and use CMS before and during the quality communication as noted below, is to check their data entry in the CMS measure submission process. For sufficient to ensure ACOs’ Web Interface to assist ACOs in example, ACOs may access measure understanding of and compliance with monitoring the accuracy of the quality specification documents that are quality measure submission data they submit. These reports can help available on our Web site, contact the requirements. We therefore will not ACOs to identify and correct errors in dedicated help desk, and attend delay implementation of the new their data submission during the webinars that we hold to educate ACOs streamlined audit process and will use timeframe the CMS Web Interface is about measure specifications and it beginning in spring 2017 to validate open for quality data submission. Even reporting requirements. Therefore, we data received from ACOs for the 2016 so, we believe there may be instances believe that this modification of our performance year. following an audit when CMS may need proposal addresses stakeholder

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concerns while permitting us to perform c. Technical Changes Related to Quality performance standard changes, timely quality validation audits that Reporting Requirements depending on the performance year, the hold ACOs accountable not only for the In this section of the CY 2017 PFS ACO may be subject to multiple quality quality of the care they provide but also proposed rule, we proposed several performance standards over the course for the accuracy of their quality technical changes to the quality of its 3-year agreement period. We reporting. performance standard that an ACO must stated that we recognize that some of the Final Action: For the reasons meet to be eligible to share in savings, language used in subsequent revisions discussed above, we are finalizing our as established in the November 2011 to our regulations may have generated proposed changes to the audit process final rule. Part of the determination of some confusion related to this issue. We with modification. Specifically, we are whether an ACO has met the quality clarified that while there are certain finalizing a policy under which we will reporting standard in each year is standards that must be met for each audit enough medical records to achieve dependent on the ACO meeting the measure or in each domain, there is one a 90 percent confidence interval; minimum attainment level for certain overall quality performance standard that must be met in each performance conduct the audit in a single phase; and measures. We discussed how the year by an ACO. Therefore, we proposed calculate an overall audit performance ‘‘minimum attainment’’ requirement has to make conforming changes to the rate. We are modifying our regulations been implemented to date and proposed regulations text to remove references to in order to reflect the new process of a modification that we believe is more the quality performance standard in conducting the quality validation audit consistent with our policies for contexts where it does not appear to in a single step by removing the assessing an ACO’s performance over apply to the overall quality performance provision at § 425.500(e)(2) that requires time. Finally, we proposed to move standard (particularly §§ 425.316(c)(2), 3 phases of medical record review. In so references to compliance actions from 425.502(a)(4), and 425.502(d)(1)). We doing, we are redesignating § 425.502(d)(2)(ii) to a more appropriate proposed to retain certain references to § 425.500(e)(3) as § 425.500(e)(2). We are provision at § 425.316(c). multiple quality performance standards, also revising the newly redesignated First, we proposed to make technical revisions to ensure stakeholder such as the reference at § 425.100(b), provision at § 425.500(e)(2) in order to because we believe the use of the plural provide for an assessment of the ACO’s understanding of the definition of the quality performance standard. The is appropriate in certain contexts as the overall audit match rate across all quality performance standard varies measures, instead of assessing the quality performance standard is established under Subpart F for each depending on the performance year in ACO’s audit mismatch rate at the question. measure level. For the reasons noted in performance year (§ 425.502(a)). For the our responses to comments above, we first performance year of an ACO’s first Second, we addressed the concept of are modifying our proposed policy in agreement period, the quality the minimum attainment level and its order to give CMS discretion, in certain performance standard is defined as use in determining whether an ACO has met the quality performance standard. unusual circumstances, not to adjust the complete and accurate reporting of all As noted above, beginning in the second ACO’s overall quality score when the quality measures. For each subsequent year of an ACO’s first agreement period, ACO has an audit mismatch rate of performance year, quality measures the quality performance standard is met greater than 10 percent. Specifically, we phase in to pay for performance, and by complete and accurate reporting on are revising the redesignated provision although the ACO must continue to all measures, but also includes meeting at § 425.500(e)(2), to indicate that if an report all measures completely and the minimum attainment level on ACO has an overall audit match rate of accurately, the ACO will also be assessed on performance based on the ‘‘certain’’ measures. As provided at less than 90 percent, absent unusual quality performance benchmark and § 425.502(b)(1), we designate a circumstances, CMS will adjust the minimum attainment level of certain performance benchmark and minimum ACO’s overall quality score proportional measures that are designated as pay for attainment level for each measure. to its audit performance. Thus, CMS performance. The quality performance Pursuant to § 425.502(b)(3), the will retain discretion to avoid making standard that applies to an ACO’s final minimum attainment level is set at 30 the adjustment if circumstances year in its first agreement period also percent or the 30th percentile of the warrant. applies to each year of an ACO’s performance benchmark. In Finally, we are finalizing our proposal subsequent agreement period § 425.502(c)(1) through (c)(2), we state to add a new requirement at (§ 425.502(a)(3)) (79 FR 67925 through that performance below the minimum § 425.500(e)(3) that an ACO that has an 67926). ACOs must meet or exceed the attainment level for a measure will audit match rate of less than 90 percent minimum quality performance standard receive zero points for that measure and may be required to submit a corrective in a given performance year to be performance equal to or greater than the action plan (CAP) under § 425.216 for eligible to receive payments for shared minimum attainment level for a CMS approval. In the CAP, the ACO savings (§ 425.100(b)). Conversely, measure will receive points on a sliding would be required to explain the failure to meet the quality performance scale based on the level of performance. reasons for the low audit match rate and standard in a given performance year Finally, § 425.502(d) outlines quality how it plans to improve the accuracy of makes ACOs ineligible to share in performance requirements for the four its quality reporting in the future. In savings, even if generated, and such domains, stating that the ACO must addition, we maintain the right, as ACOs may be subject to compliance report all measures in a domain and described in § 425.500(f), to terminate or actions. must score above the minimum impose other sanctions on any ACO that In the proposed rule, we explained attainment level determined by CMS on does not report quality data accurately, that our intent in the November 2011 70 percent of the measures in each completely or timely. We will apply final rule was to establish a single domain. If the ACO fails to achieve the these policies to the quality validation quality performance standard that minimum attainment level on at least 70 audits beginning in 2017 with the would apply for each performance year percent of the measures in a domain, quality validation audits of quality in which an ACO participates in the CMS will take compliance action. reporting for the 2016 performance year. program. Because the quality Additionally, the ACO must achieve the

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minimum attainment level for at least specific performance levels at which a measures increases the likelihood that one measure in each of the four domains compliance action would be triggered the ACO will receive a warning letter or to be eligible to share in savings. In from § 425.502 to § 425.316. CAP. It was not our intent to subject an guidance, we have interpreted the The following is a summary of the ACO to compliance action based on its quality performance requirements for comments we received regarding the poor performance on just one measure domains to apply only to pay for proposed technical changes related to in a domain. Therefore, including pay performance measures because the quality performance standard and for reporting measures in this minimum attainment applies only to minimum attainment level. assessment limits the issuance of ‘‘certain’’ measures according to the Comment: We received few comments warning letters and CAPs to only those definition of the quality performance on the proposed technical changes. ACOs that have grossly underperformed standard in § 425.502(a)(3), and we have Most commenters generally supported in a domain by failing to meet the interpreted the reference to ‘‘certain’’ these proposals. However, some minimum attainment level on at least 70 measures in § 425.502(a)(2) to mean pay commenters expressed concerns about percent of the measures in a domain, for performance measures. In the including pay for reporting measures in including measures that are designated proposed rule, we explained that, as a our assessment of whether the ACO as pay for reporting. Therefore, we are result of this interpretation, we believe could meet the minimum attainment finalizing this policy as proposed. We an inconsistency in the application of level on 70 percent of measures within intend to include these changes in the the policy goals outlined in our a domain. For example, one commenter ‘‘Medicare Shared Savings Program November 2011 final rule has arisen. In seemed to believe that we had proposed Quality Measurement Methodology and particular, we believe certain current that an ACO must meet the 30th percent Resources’’ document posted on the policies are inconsistent with our goal or percentile threshold for all measures, Shared Savings Program Portal where it of holding ACOs to higher quality including pay for reporting measures. will be available to all ACOs. reporting standards over time. One commenter expressed concerns Final Action: We are finalizing the Specifically, because measures are about whether an ACO would be able to technical changes related to the use of phased-in from pay for reporting to pay meet the pay for performance minimum the term ‘‘quality performance for performance over the course of an attainment level on newly introduced standard’’ and the application of the ACO’s first 3-year agreement period, measures, and therefore, recommended ‘‘minimum attainment level’’ to there are no pay for performance not including pay for reporting determine whether an ACO has met the measures during PY1 and fewer pay for measures in our assessment of whether quality performance standard for a performance measures in each domain an ACO has met the minimum performance year as proposed for the in PY2 compared to PY3. Thus, under attainment level on 70 percent of reasons discussed above and in the measures in a domain. Commenters also our current interpretation of the rules, it proposed rule. Specifically, we are requested that these technical changes is not possible to take compliance making the following modifications to be disseminated to all ACOs. our regulations: actions against an ACO in its first Response: We thank commenters for • performance year for failure to achieve Revise introductory text at their support of our proposed policies § 425.502(a) to clarify that the quality the minimum attainment level on at and wish to clarify several points for least 70 percent of the measures in a performance standard is the overall those who expressed concerns regarding standard the ACO must meet to qualify domain because there are no pay for the proposed changes. First, we performance measures on which to to share in savings. emphasize that we proposed to continue • Replace the word ‘‘certain’’ in assess performance on a domain. to define the ‘‘minimum attainment § 425.502(a)(2) and (3) with ‘‘all,’’ so Additionally, because there are fewer level’’ for pay for performance measures that the term ‘‘minimum attainment pay for performance measures in PY2 at the level of the 30th percent or 30th level’’ clearly applies to both pay for than in PY3, and because of our policy percentile. We also wish to clarify that reporting and pay for performance of designating new measures as pay for we proposed to define the ‘‘minimum measures. reporting, it is more likely that a attainment level’’ for pay for reporting • At § 425.502(a)(4), make compliance action would be taken measures at the level of complete and modifications to remove the reference to against an ACO due to failure to meet accurate reporting. In other words, the the quality performance standard each the minimum attainment level on 70 minimum requirement for attainment on time it appears to avoid causing percent of the pay for performance a particular measure is different confusion between the standards for measures in a domain in PY2 than in depending on whether the measure is individual measures and the overall PY3. We explained that, as a result of designated as pay for reporting or pay quality performance standard. this experience, we now believe it for performance. Because newly • At § 425.502(b)(3), define would be more consistent with our introduced measures are pay for ‘‘minimum attainment level’’ for both policy goals to take all measures into reporting for the first 2 years, the pay for reporting and pay for account when determining whether a minimum attainment standard level for performance measures. We will set the compliance action should be taken new measures would be pay for minimum attainment level for pay for against an ACO based on its quality reporting. Second, including all performance measures at the 30th performance in one or more domains. measures in the domain (rather than percent or 30th percentile of the quality Therefore, we proposed to take all including only the pay for performance performance benchmark and for pay for measures into account when measures) in our assessment of whether reporting measures at the level of determining ACO performance at the the ACO has met the minimum complete and accurate reporting. domain level for purposes of attainment level on 70 percent of the • At § 425.502(c)(2), revise the compliance actions. Additionally, we measures in the domain has an end regulation text to specify that only pay stated that we believe compliance result of insulating many ACOs that for performance measures are assessed actions should be addressed at § 425.316 would otherwise be subject to a warning on a sliding scale. rather than in the quality reporting letter or CAP. Some domains have very • At § 425.502(c)(5), add a provision section, and therefore, we proposed to few pay for performance measures and to specify that pay for reporting move the provisions governing the poor performance on just one of those measures earn the maximum number of

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points for a measure when the to CMS, and in § 425.502(b)(2)(ii), reporting requirements and payment minimum attainment level is met. which contains an extra ‘‘t’’ at the end rules related to the PQRS into the • Modify § 425.502(d) to refer of ‘‘percent.’’ Shared Savings Program at § 425.504 for generally to compliance actions that The following is a summary of the ‘‘eligible professionals’’ (EPs) who bill may be taken for failure to meet quality comments we received regarding the under the TIN of an ACO participant requirements, including low quality proposed technical change to the within an ACO. Thus, the Shared performance. application of flat percentages for Savings Program rules provide that EPs We are also modifying § 425.316(c)(1) quality benchmarks. who bill under the TIN of an ACO and (c)(2) to address the specific levels Comment: We received three participant within an ACO may only of quality performance at which comments on this proposal. All were participate under their ACO participant compliance action will be triggered and supportive of the proposed technical TIN as a group practice under PQRS to reference the single quality change. One commenter requested that under the Shared Savings Program for performance standard that an ACO must CMS clarify which measures are purposes of qualifying for a PQRS meet in order to remain eligible to calculated as percentages versus ratios. incentive (prior to 2015) or avoiding the participate in the Shared Savings Response: We thank the commenters payment adjustment (starting in 2015). Program. for their support of this proposed In other words, the current regulations technical change. When we release the prohibit ACO participant TINs and the d. Technical Change to Application of quality measure benchmarks for the Flat Percentages for Quality Benchmarks EPs billing through those TINs from 2017 performance year as part of our participating in PQRS outside of the As explained in greater detail in the operational documents and guidance, Shared Savings Program such that these CY 2017 PFS proposed rule, we we will indicate which measures are entities may not independently report previously finalized a methodology to calculated as ratios, and therefore, for purposes of PQRS apart from the spread clustered measures when setting exempt from our policies with respect to ACO. quality benchmarks to promote a the use of flat percentages. An ACO, reporting on behalf of its clinically meaningful assessment of Final Action: We are finalizing our EPs for purposes of PQRS, is required to ACO quality. Specifically, we finalized proposed technical change to the use of satisfactorily submit through the CMS a policy that CMS would set quality flat percentages to set quality web interface all of the ACO GPRO benchmarks using flat percentages for a performance benchmarks. Specifically, measures that are part of the Shared clustered measure when the national we will no longer use flat percentages to Savings Program quality performance FFS data results in the 60th percentile set the quality performance benchmark standard. Under § 425.504(c), for 2016 for the measure are equal to or greater for quality performance measures and subsequent years, if an ACO fails to than 80.00 percent. We noted that the calculated as ratios. Such measures will satisfactorily report all of the ACO methodology would not apply to be clearly identified in operational GPRO measures through the CMS web measures whose performance rates are documents posted on our Web site. In interface each EP who bills under the calculated as ratios, for example, addition, we are finalizing the two TIN of an ACO participant within the measures such as the two ACO technical changes to address ACO will receive a downward Ambulatory Sensitive Conditions typographical errors in § 425.502(a)(1), adjustment, as described in § 414.90(e) Admissions and the All Condition which contains a duplicative reference for that year. In the 2017 PFS proposed Readmission measures. We to CMS, and in § 425.502(b)(2)(ii), rule, we noted that the current subsequently finalized a policy to which contains an extra ‘‘t’’ at the end regulations do not provide any address ‘‘topped out’’ measures by of ‘‘percent.’’ mechanism for these EPs to report setting benchmarks using flat separately or otherwise avoid the percentages when the 90th percentile is e. Incorporation of Other Reporting Requirements Related to the PQRS downward payment adjustment if the equal to or greater than 95 percent. ACO fails to satisfactorily report on Although similar to the ‘‘cluster’’ policy The Affordable Care Act gives the their behalf. We also summarized the finalized earlier, we included measures Secretary authority to incorporate reasons discussed in the November 2011 whose performance rates are calculated reporting requirements and incentive final rule for not allowing EPs who bill as ratios. We believed this policy was payments from certain Medicare under the TIN of an ACO participant to appropriate because measures programs into the Shared Savings report outside their ACO for purposes of calculated and reported as ratios may Program, and to use alternative criteria PQRS. become topped out and we wanted to to determine if payments are warranted. Since publication of the November treat all topped out measures Specifically, section 1899(b)(3)(D) of the 2011 final rule, we have gained consistently. Act affords the Secretary discretion to experience with these policies and Since these policies were adopted, we incorporate reporting requirements and program operations, and now believe have determined that converting incentive payments related to the there may be limited instances in which measures calculated and reported as physician quality reporting initiative it would be appropriate to use data that ratios into benchmarks expressed as (PQRI), under section 1848 of the Act, is reported by these EPs outside their percentiles and percentages creates including such requirements and such ACO for purposes of PQRS. Therefore, confusion in the interpretation of payments related to electronic we proposed a change in policy in order quality results and may yield results prescribing, electronic health records, to be able to accept and use data that is that are contrary to the intended and other similar initiatives under separately reported outside the ACO by purpose of using flat percentages. As a section 1848, and permits the Secretary EPs billing through the TIN of an ACO result, we proposed to no longer apply to use alternative criteria than would participant within an ACO for purposes the flat percentage policy to otherwise apply under section 1848 of of PQRS under limited circumstances performance measures calculated as the Act for determining whether to for the final 2 years of PQRS before it ratios. In addition, we proposed two make such payments. Under this sunsets and is replaced by the Quality technical changes to address authority, in the November 2011 final Payment Program (QPP). We stated that typographical errors in § 425.502(a)(1), rule establishing the Shared Savings we continue to believe that in most which contains a duplicative reference Program, we incorporated certain cases it is appropriate to assess EPs that

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bill through the TIN of an ACO First, we stated that we believe it is bill under the TIN of an ACO participant under the PQRS as a group necessary to protect EPs that participate participant fall into Category 2 for the practice because as noted in the in ACOs that fail to satisfactorily report VM and are subject to a downward November 2011 final rule, the Shared all of the ACO GPRO measures. payment adjustment. Our proposed and Savings Program is concerned with Although 98 percent of ACOs final policies for how quality data measuring the quality of care furnished successfully complete required quality reported by EPs billing under the TINs to an assigned population of FFS reporting annually, there have been a of ACO participants that is reported beneficiaries by the ACO, as a whole, few instances where an ACO has failed apart from the ACO will be used for and not that of individual ACO to report all of the required measures, purposes of avoiding the VM downward providers/suppliers. We explained that for example, where an ACO has payment adjustment for 2017 and 2018 we believe this framework promotes terminated its participation in the are discussed in section III.L.3.b of this clinical integration among the ACO Shared Savings Program and did not final rule. providers/suppliers, which is an quality report on behalf of the EPs that For the reasons noted above, we important aspect of the Shared Savings bill under the TIN of an ACO stated that we believed it would be Program. In addition, it is consistent participant at the end of the appropriate to retain the provisions with the requirement under § 425.108(d) performance year as required under our under § 425.504 that require the ACO to that each ACO provider/supplier must close-out procedures. In other instances, report all of the ACO GPRO measures to demonstrate a meaningful commitment some ACOs continued to participate in satisfactorily report on behalf of the EPs to the mission of the ACO to ensure its the Shared Savings Program but failed who bill under the TIN of an ACO likely success. Because an ACO cannot to complete quality reporting in a timely participant for purposes of the PQRS be successful in the Shared Savings manner. In these instances, the lack of payment adjustment; however, we Program without satisfying the quality complete quality reporting by the ACO proposed to modify the provisions that reporting requirements, we believe a translated into a failure for the EPs prohibit EPs that bill under the TIN of meaningful commitment by ACO within the ACO to receive a PQRS an ACO participant from reporting apart providers/suppliers to the mission of incentive (or to avoid the PQRS from the ACO. Specifically, we the ACO includes assisting with and downward adjustment) for that year. proposed to add a redesignated and engaging in annual quality reporting Second, PQRS has transitioned away revised paragraph at § 425.504(d) to through the ACO. Further, ACO from providing incentive payments to address the requirement that the ACO reporting reduces burden for those in applying only downward payment report on behalf of the eligible small or solo practices, and places a adjustments to payments under the professionals who bill under the TIN of focus on population health by Medicare Physician Fee Schedule, an ACO participant for purposes of the encouraging care coordination by ACO making it even more important for EPs 2017 and 2018 PQRS payment providers/suppliers to improve the to ensure they comply with the adjustment. Under this revised health of the broader patient population reporting requirements for PQRS. Under provision the prohibition on separate for which they are responsible. Finally, the current rules, EPs who bill under the quality reporting for purposes of the we believe that such group reporting is TIN of an ACO participant within an PQRS payment adjustment for 2017 and consistent with group reporting under ACO must ultimately rely on the ACO 2018 would be removed. We also various other CMS initiatives, and to report on their behalf. These EPs are proposed to make a technical change to only able to encourage and facilitate § 425.504 to move existing § 425.504(d) therefore, we stated that we did not ACO reporting, but lack the ability to to § 425.504(c)(5) because the intent of intend to remove the requirement that ensure that the ACO satisfactorily this provision was to parallel the ACOs report on behalf of the EPs who reports in order to prevent application language of § 425.504(b)(6) for purposes bill under the TIN of an ACO of the payment adjustment. The of the payment adjustment for 2016 and participant. As a corollary, we stated proposed change to allow EPs to report subsequent years. We reiterated our our intent to continue to use ACO data separately would provide them a intent that data reported by an ACO preferentially for purposes of assessing mechanism over which they have direct would continue to be preferentially or determining an EP’s quality control to ensure satisfactory reporting used for purposes of other CMS performance for purposes of programs occurs. Additionally, we noted that initiatives that rely on such data, such as PQRS or, by extension, the VM. because there are no more payment including the PQRS and the VM. If an However, we went on to explain in incentives under the PQRS, there is no EP who bills under the TIN of an ACO the proposed rule that we believe that longer any concern that an EP may participant chooses to report apart from when an ACO does not satisfactorily inadvertently receive duplicative PQRS the ACO, the EP’s data may be used for report for purposes of PQRS, it may be incentive payments from CMS. We purposes of PQRS and VM only when appropriate to accept and use data that address the specific issues and policies complete ACO reported data is not is reported outside the ACO. In order to related to the use of data reported by available. Additionally, we noted that be able to accept and use data reported EPs apart from an ACO for purposes of under the Shared Savings Program, only outside the ACO for purposes of PQRS, avoiding the PQRS payment adjustment the quality data reported by the ACO as we noted that we must modify the for payment years 2017 and 2018 in required under § 425.500 would be used provision at § 425.504 prohibiting EPs section III.H. of this final rule. to assess the ACO’s performance under that bill under the TIN of an ACO Third, under the VM, groups and solo the Shared Savings Program. In other participant in an ACO from reporting practitioners that bill under the TIN of words, quality data submitted separately separately for purposes of PQRS. We an ACO participant are evaluated under from the ACO would not be considered therefore proposed to modify § 425.504 a quality tiering methodology and could under the Shared Savings Program. We to lift the prohibition on separate qualify for an upward payment requested comments on this proposal. reporting for purposes of the 2017 and adjustment if the ACO satisfactorily The following is a summary of the 2018 PQRS payment adjustment. We reports on their behalf. However, if the comments we received regarding our explained that we believe this change to ACO does not satisfactorily report proposed changes to the reporting our program rules was necessary for quality data as required under § 425.504 requirements under the Shared Savings several reasons. then groups and solo practitioners that Program related to PQRS.

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Comment: Commenters supported the does not alter or impact our assessment (EHR) Incentive Program into a single proposal to allow EPs to report apart of an ACO’s quality under the Shared program in which eligible clinicians from the ACO to meet PQRS reporting Savings Program. Only quality data (ECs) will be measured over 4 categories requirements and to avoid the PQRS reported by the ACO as required under which include quality, resource use, adjustment. Additionally, commenters § 425.500 will be used to assess the clinical practice improvement, and supported maintaining this policy as ACO’s performance under the Shared advancing care information. The CMS transitions to the Quality Payment Savings Program. rulemaking implementing the QPP Program (QPP). Several commenters specifically addresses ECs that raised issues related to PQRS proposals f. Alignment With the Quality Payment participate in APMs and Advanced discussed in section III.H related to Program (QPP) APMs, such as the Shared Savings reporting requirements and timing, and 1. Background and Introduction to the Program. Specifically, for ECs suggested alternatives to allow EPs who Quality Payment Program participating in APMs, the QPP final bill under the TIN of an ACO rule with comment period: The Medicare Access and CHIP • participant to avoid the PQRS Reauthorization Act of 2015 (MACRA) Establishes criteria for reporting downward payment adjustment when (Pub. L. 114–10, enacted April 16, under each of the 4 categories. For their ACO fails to report. For example, 2015), amended title XVIII of the Act to example, the QPP final rule with several commenters were concerned repeal the Medicare sustainable growth comment period establishes a policy for about the effort and expense that would rate (SGR) and strengthen Medicare the quality performance category to use quality information submitted by the be incurred by EPs to report apart from access by improving physician ACO through the CMS Web interface to their ACO without first knowing if the payments and making other assess each EC billing under the TIN of ACO had satisfactorily reported. A few improvements. The statute established an ACO participant. To assess commenters recommended that EPs be the Merit-Based Incentive Payment performance in the category of held harmless and not incur a System (MIPS), a new program for advancing care information performance downward payment adjustment under certain Medicare-participating category for ECs billing under the TIN PQRS or the VM if their ACO failed to practitioners. MIPS consolidates of an ACO participant, we will aggregate report. components of three existing programs, Response: We appreciate commenters’ EC-reported data to calculate an ACO the PQRS, the Physician Value Modifier support for our proposal to modify score which will be applied to each (VM), and the Medicare Electronic program rules to permit EPs to report participating EC. Under the QPP final quality apart from an ACO. Additional Health Record (EHR) Incentive Program rule with comment period, this comments having to do with EP for EPs. The statute also established reporting by ECs will be accomplished reporting for purposes of PQRS and the incentives for participation in certain by each ACO participant TIN reporting VM are addressed in sections III.H and alternative payment models (APMs). On on the advancing care information as III.L.3.b of this final rule, respectively. April 27, 2016, the Department of specified in § 414.1375(b). We note that Comments related to timing and Health and Human Services (HHS) under the QPP final rule with comment submission of quality data apart from issued a proposed rule to implement period, ECs for whom a sufficient the ACO for purposes of the QPP have key provisions of the MACRA and percentage of payments for covered been shared with the appropriate staff. establish a new Quality Payment professional services, or a sufficient Final Action: We are finalizing our Program (QPP) (Medicare Program; percentage of patients, are attributable proposal to allow EPs that bill under the Merit-Based Incentive Payment System to services furnished through an TIN of an ACO participant to report for (MIPS) and Alternative Payment Model Advanced APM for a year will be purposes of PQRS apart from the ACO. (APM) Incentive under the Physician qualifying APM participants (QPs) for For the reasons noted above, we are also Fee Schedule, and Criteria for the year. In addition to earning a 5 finalizing our proposal to add a Physician-Focused Payment Models (81 percent APM Incentive Payment, QPs redesignated and revised paragraph at FR 28162 through 28586) (the QPP are exempt from the MIPS reporting § 425.504(d) to address the requirement proposed rule)). On October 19, 2016, requirements and payment adjustment that the ACO report on behalf of the HHS issued the final rule with comment for the year. eligible professionals who bill under the period establishing the Quality Payment • Defines an Advanced APM as one TIN of an ACO participant for purposes Program (QPP final rule with comment that meets several criteria including of the 2017 and 2018 PQRS payment period). (The rule will publish in the requiring participants to use certified adjustment. We are also finalizing our November 4, 2016 Federal Register and EHR technology (CEHRT). Under the proposal to make a technical change to can be accessed at https://qpp.cms.gov/ QPP final rule with comment period, § 425.504 to move existing § 425.504(d) education.) The Quality Payment only Tracks 2 and 3 of the Shared to § 425.504(c)(5) because the intent of Program (QPP) replaces a patchwork Savings Program have the potential to this provision was to parallel the system of Medicare reporting programs meet all criteria necessary for language of § 425.504(b)(6) for purposes with a flexible system that allows designation as an Advanced APM. In of the payment adjustment for 2016 and practitioners to choose from two paths order for Tracks 2 and 3 of the Shared subsequent years. Details regarding the that link quality to payments: The Savings Program to meet the CEHRT requirements for reporting quality data Merit-Based Incentive Payment System requirement for Advanced APMs, the apart from the ACO and the use of such (MIPS) and the APM incentive Shared Savings Program must hold quality data for purposes of PQRS and participation in Advanced Alternative ACOs accountable for their participating the VM are addressed in sections III.H. Payment Models (APMs). MIPS and the eligible clinicians’ use of CEHRT by and III.L.3.b. of this final rule, APM incentive will impact practitioner applying a penalty or reward based on respectively. We reiterate, however, that payments beginning in payment year the degree of use of CEHRT (such as the these revisions to our regulations in 2019 based on 2017 reporting. MIPS is percentage of EPs that are using CEHRT order to allow quality data to be a new program that combines parts of or the care coordination or other submitted apart from the ACO and for the Physician Quality Reporting System activities performed using CEHRT). such quality data to be used under other (PQRS), Value Modifier (VM) and In the 2017 PFS proposed rule, we programs (such as PQRS or the VM) Medicare Electronic Health Record reviewed the Shared Savings Program

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rules and identified several that ACOs, ACO participants, and ACO Currently, ACOs are required under modifications to program rules that we providers/suppliers are encouraged to § 425.504 to report certain quality believed needed to be made in order to develop a robust EHR infrastructure, measures on behalf of the EPs who bill support and align with the QPP. These which aligns with our eligibility criteria under the TIN of an ACO participant for modifications included the following: under § 425.112 that require ACOs to purposes of PQRS. Under the policy • Revisions to §§ 425.504 and define care coordination processes, proposed in the QPP proposed and 425.506 to sunset Shared Savings which may include the use of enabling subsequently adopted in the QPP final Program alignment with PQRS and the technologies such as CEHRT. At rule with comment period, the quality EHR Incentive Program starting with § 425.506(b) and (c) we state that the data submitted to the CMS Web quality reporting period 2017 quality measure regarding EHR adoption interface by ACOs will satisfy the (corresponding to payment year 2019). is measured based on a sliding scale and quality performance category for ECs • Addition of new paragraph that it is weighted twice that of any participating in the ACO. Therefore, in § 425.506(e) and section § 425.508 to other measure for scoring purposes and order to align with the QPP, we align with the proposed Quality determining compliance with quality proposed to add a new paragraph at Payment Program, including rules performance requirements for domains. § 425.508(a) that parallels the current addressing annual assessment of the use To align with the EHR incentive requirement at § 425.504 for reporting of CEHRT by ECs participating in ACOs program we state in § 425.506(d), that on behalf of EPs who bill under the TIN and for ACO reporting of certain quality EPs participating in an ACO under the of an ACO participant for purposes of measures to satisfy the quality Shared Savings Program satisfy the PQRS. Specifically, we proposed to performance category on behalf of the CQM reporting component of require that ACOs, on behalf of ECs who eligible clinicians who bill under the meaningful use for the Medicare EHR bill under the TIN of an ACO TIN of an ACO participant. Incentive Program when the EP extracts participant, must submit all the ACO • Modifications to the EHR measure data necessary for the ACO to satisfy the CMS Web interface measures required title and specifications necessary to quality reporting requirements under by the Shared Savings Program using a align with the proposed QPP criteria for the Shared Savings Program from CMS Web interface, to meet reporting determining Advanced APM status, CEHRT and when the ACO reports the requirements for the quality including scoring requirements for the ACO GPRO measures through a CMS performance category under MIPS. limited circumstances when the Web interface. EPs are responsible for Because we proposed to maintain measure is designated as pay for meeting the rest of the EHR incentive flexibility for EPs to report quality reporting. program requirements apart from the performance category data separately 2. Proposals Related to Sunsetting PQRS ACO. from the ACO for purposes of PQRS, we and EHR Incentive Program Alignment As noted above, the VM, PQRS and did not propose to include a provision and Alignment With APM Reporting the EHR incentive programs are that would restrict an EC from reporting Requirements Under the Quality sunsetting and the last quality reporting outside the ACO for purposes of the Payment Program period under these programs will be QPP. While the intent of these proposals 2016, which will impact payments in was to permit flexibility in reporting The Shared Savings Program has 2018. Quality reporting under the QPP, quality data, we reiterated that no established rules at §§ 425.504 and as proposed and subsequently finalized, quality data reported apart from the 425.506 incorporating reporting will begin in 2017 for payment year ACO would be considered for purposes requirements related to PQRS and the 2019. In order to align with the policies of assessing the quality performance of EHR Incentive Program. The current proposed in the QPP proposed rule (and the ACO under the Shared Savings provision at § 425.504(c), addresses the that were subsequently finalized in the Program. PQRS payment adjustment for 2016 and QPP final rule with comment period), The following is a summary of the subsequent years. Under current Shared we proposed to amend §§ 425.504 and comments we received regarding our Savings Program rules, EPs who bill 425.506 to indicate that these reporting proposals to sunset PQRS and EHR under the TIN of an ACO participant requirements would apply to ACOs and Incentive Program alignment and to within an ACO may only participate their EPs through the 2016 performance align with the reporting requirements under their ACO participant TIN as a year. Specifically, at § 425.504(c) we under the QPP. group practice under the PQRS Group proposed to remove the phrase ‘‘for Comment: Commenters were Practice Reporting Option for purposes 2016 and subsequent performance supportive of our efforts to align Shared of the PQRS payment adjustment under years’’ each time it appears and add in Savings Program ACO quality reporting the Shared Savings Program. ACOs must its place the phrase ‘‘for 2016.’’ As with the MIPS quality performance submit all of the ACO GPRO measures discussed above, we proposed and are category. In addition, commenters to satisfactorily report on behalf of their finalizing a technical change to supported the proposal to allow ECs to eligible professionals for purposes of the redesignate paragraph (d) as paragraph report outside of the ACO for purposes PQRS payment adjustment. If an ACO (c)(5) and then to add new paragraph (d) of the QPP, in the event that the ACO does not satisfactorily report, each EP to address the PQRS alignment rules for fails to satisfactorily report. participating in the ACO receives a the 2017 and 2018 PQRS payment Response: We appreciate commenters’ payment adjustment under PQRS. As adjustment. Similarly, at § 425.506, we support for our proposals to align ACO discussed in this final rule, we are proposed to revise paragraph (d) to quality reporting with the sunsetting of finalizing a policy that will allow EPs indicate that the last reporting year for PQRS and the EHR Incentive Program who bill under the TIN of an ACO the EHR Incentive Program is 2016. and the new reporting requirements participant within an ACO to report In addition, in the CY 2017 PFS under the QPP. separately from their ACO for purposes proposed rule, we proposed to require Final Action: We are finalizing our of the PQRS payment adjustment for ACOs, on behalf of the ECs who bill proposal to sunset PQRS and EHR 2017 and 2018. under the TIN of an ACO participant, to Incentive Program alignment and to At § 425.506, we address alignment report quality measures through the align with the reporting requirements with the EHR Incentive Program. CMS Web interface in order to satisfy under the QPP. Specifically, we will Specifically, at § 425.506(a), we state the QPP quality performance category. amend §§ 425.504 and 425.506 to

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indicate that the PQRS and EHR APM criteria while other tracks or accountable for their ECs’ use of CEHRT Incentive Program reporting options may not. Under the approach by applying a financial penalty or requirements apply to ACOs and their discussed in the QPP proposed rule and reward based on the degree of CEHRT EPs through the 2016 performance year. as subsequently adopted in the QPP use (such as the percentage of ECs that To align with the reporting final rule with comment period, while use CEHRT or the engagement in care requirements under the QPP, we are all Tracks of the Shared Savings coordination or other activities using finalizing our proposal to add a new Program would meet the criterion to CEHRT). In the rulemaking for the QPP, provision at § 425.508 that parallels the provide for payment based on quality we noted that the current EHR quality current requirement at § 425.504 that measures comparable to those used in measure at ACO #11 assesses the degree ACOs report on behalf of EPs who bill the quality performance category of to which certain ECs in the ACO under the TIN of an ACO participant for MIPS, only Tracks 2 and 3 meet the successfully meet the requirements of purposes of PQRS. Specifically, we are proposed financial risk standard to bear the EHR Incentive Program, and we finalizing our proposal to require that more than a nominal amount of risk for stated that ‘‘[s]uccessful reporting of the ACOs, on behalf of ECs who bill under monetary losses. measure for a performance year gives the TIN of an ACO participant, must In the rulemaking to establish the the ACO points toward its overall submit all the CMS Web interface QPP, we adopted an alternative criterion quality score, which in turn affects the measures required by the Shared that would allow all three tracks of the amount of shared savings or shared Savings Program using a CMS Web Shared Savings Program to satisfy the losses an ACO could earn or be liable interface, to meet reporting EHR criterion if ACOs are held for, respectively.’’ Finally, we stated requirements for the quality accountable for their ECs’ use of that we believed the alternative criterion performance category under the QPP. As CEHRT. In the QPP final rule with meets the statutory requirement because discussed elsewhere in this final rule, comment period, we adopted a the alternative criterion builds on we are also finalizing a policy to definition of CEHRT at § 414.1305 for established Shared Savings Program maintain flexibility for EPs to report purposes of MIPS and the APM rules and incentives that directly tie the quality data separately from the ACO for incentive. We noted that section level of CEHRT use to the ACO’s purposes of PQRS and the VM, and financial reward which in turn has the 1833(z)(3)(D)(i)(I) of the statute does not therefore, are not including a provision effect of directly incentivizing ever- specify how the APM must require that would restrict an EC from reporting increasing levels of CEHRT use among participants to use CEHRT in order to be outside the ACO for purposes of the participating clinicians. QPP. While the intent of this policy is an Advanced APM. For this reason, we In the CY 2017 PFS proposed rule, we to permit flexibility in reporting quality stated that we believed it was proposed several modifications to our data for purposes of the QPP, we reasonable to use discretion when program rules in order to align with the reiterate that no quality data reported determining the details of how APMs policies proposed for the QPP. apart from the ACO will be considered might meet this criterion. For purposes First, we proposed to modify the title for purposes of assessing the quality of the APM incentive under the QPP, we and specifications of the EHR quality performance of the ACO under the proposed and subsequently finalized a measure (ACO #11). This measure is Shared Savings Program. policy that an Advanced APM must currently titled Percent of PCPs Who require at least 50 percent of ECs who Successfully Meet Meaningful Use 3. Proposals Related to Alignment With are enrolled in Medicare (or each Requirements. Under the current Shared the Quality Payment Program (QPP) hospital if hospitals are the APM Savings Program rules, ACOs must In the QPP proposed rule (81 FR participants) to use the certified health report on and are held accountable for 28296) and in the subsequent QPP final IT functions outlined in the definition certain measures that make up the rule with comment period, we outlined of CEHRT to document and quality reporting standard. One of these and defined the criteria for Advanced communicate clinical care with patients measures, ACO #11, assesses the degree APMs, APMs through which ECs would and other health care professionals. of CEHRT use by primary care have the opportunity to become However, although the Shared Savings physicians participating in the ACO and Qualified Participants (QPs) as specified Program requires ACOs to encourage performance on this measure is in section 1833(z)(3)(C) and (D) of the and promote the use of enabling weighted twice that of any other Act. First, under MACRA, for an APM technologies (such as EHRs) to measure for scoring purposes. To to be considered an Advanced APM, it coordinate care for assigned calculate this measure, CMS collects must meet three requirements: (1) beneficiaries, the Shared Savings information submitted by PCPs through Require participants to use certified Program does not require a specific level the EHR Incentive Program and EHR technology; (2) provide payment of CEHRT use for participation in the determines the rate of CEHRT use by for covered professional services based program. Instead, the Shared Savings PCPs participating in the ACO. on quality measures comparable to Program, as noted above, includes an Specifically, as explained in our those used in the quality performance assessment of EHR use as part of the guidance [https://www.cms.gov/ category of MIPS; and (3) either be a quality performance standard which Medicare/Medicare-Fee-for-Service- Medical Home Model expanded under directly impacts the amount of shared Payment/sharedsavingsprogram/ section 1115A(c) of the Act or require savings/shared losses generated by the Downloads/2015-ACO11-Percent-PCP- the participants to bear more than a ACO. Therefore, in the rulemaking to Successfully-Meeting-Meaningful-Use- nominal amount of risk for monetary establish the QPP, we proposed and Requirement.pdf ], the denominator is losses. In the rulemaking implementing subsequently finalized an alternative based on all PCPs who are participating the QPP, we established criteria for each criterion available only to the Shared in the ACO in the reporting year under of these requirements. As proposed and Savings Program. Specifically, we the Shared Savings Program and the subsequently finalized, under the QPP, proposed and subsequently finalized an numerator for the measure is based on significant distinctions between the alternative criterion that would allow the PCPs included in the denominator design of different tracks or options the Shared Savings Program to satisfy who successfully qualify to participate within an APM mean that certain tracks the EHR criterion to be an Advanced in either the Medicare or Medicaid EHR or options could meet the Advanced APM if it holds APM Entities Incentive Program in the year indicated.

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Results of this measure are used in § 425.506(e)(1) that during years in stated that we believe the existing determining the ACO’s overall quality which ACO #11 is designated as a pay Shared Savings Program rules are score which in turn determines the for reporting measure, in order for us to sufficient to permit Tracks 2 and 3 to ACO’s final sharing/loss rate and the determine that the ACO has met meet the criteria to be designated as amount of shared savings earned (or requirements for complete and accurate Advanced APMs because the EHR shared losses owed) by the ACO. reporting, at least one EC, as that term quality measure will always be used to In the QPP proposed rule, we is defined for purposes of the QPP, impact the amount of shared savings or proposed that ECs participating in an participating in the ACO must meet the losses of an ACO, regardless of whether ACO would satisfy the Advancing Care reporting requirements under the it is designated as pay for performance Information performance category under Advancing Clinical Information or pay for reporting. We noted that the the MIPS by reporting meaningful use of performance category under the QPP. EHR measure has an especially EHRs apart from the ACO (81 FR 28247, We stated that we believed this proposal significant impact on the overall quality Table 15). We subsequently finalized would safeguard the ability of Tracks 2 scoring for an ACO because it is double- this policy in the QPP final rule with and 3 to fully meet all criteria for weighted compared to any other comment period. Similar to the process designation as Advanced APMs by measure. In spite of this, we indicated currently used under the Shared ensuring the letter and spirit of the that we were considering additional Savings Program to determine what statutory criteria are met, even in the options regarding the treatment of the practitioners have met criteria for limited circumstances when ACO #11 is EHR measure under the Shared Savings meaningful use for the ACO #11 designated as pay for reporting under Program in order to further enhance the measure, we will access EC-reported the Shared Savings Program. Beginning importance of this measure and its data under the Advancing Clinical in the 2019 performance year, we impact on an ACO’s quality Information performance category to proposed that ACO #11 would be performance score and to improve assess the ACO’s overall use of CEHRT. assessed according to the phase-in alignment with the intent of the policies Because the current EHR measure at schedule indicated in Table 36 of the proposed in the QPP proposed rule. ACO–11 only assesses the degree of use proposed rule (81 FR 46421–46422) Specifically, we were considering of CEHRT by primary care physicians which is consistent with the current whether to finalize a policy that would participating in the ACO, in the CY phase-in schedule for the measure. We require the EHR measure to be pay for 2017 PFS proposed rule we proposed to further proposed to add § 425.506(e)(2) performance in all performance years, modify the EHR measure to align with reiterating our current requirement at including the first year of an ACO’s first the policy proposed for the QPP. § 425.506(b) that during pay for agreement period. Additionally, we Specifically, we proposed to change the performance years, the quality measure were considering whether to finalize a specifications of the EHR measure in regarding EHR adoption is measured policy that would require the EHR order to assess the ACO on the degree based on a sliding scale. We stated that measure to remain pay for performance, of CEHRT use by all providers and we did not intend our proposal to use even when a new EHR measure is suppliers designated as ECs under the this measure to assess the degree of introduced or there are significant QPP that are participating in the ACO, CEHRT use by ECs participating in the modifications to the specifications for rather than narrowly focusing on the ACO for purposes of meeting the the measure. We noted that such degree of use of CEHRT of only the CERHT criterion for Advanced APMs modifications may require additional primary care physicians participating in under the QPP to change the way we changes or alternative approaches to the ACO. We stated that we believed treat the measure under pay for certain current Shared Savings Program this modification to the specifications performance now. Similar to the current rules related to quality benchmarking for ACO #11 would better align with the method used by the Shared Savings and scoring. We anticipated that if such QPP and ensure a subset of ACOs in the Program to calculate the EHR measure, modifications were made, they would Shared Savings Program could qualify we stated that the data would continue only apply to the EHR measure and to be Advanced APM entities by to be derived using EC reported EHR would not impact current scoring and participating in an Advanced APM. We data that is required and collected for benchmarking rules for other quality also proposed to modify the title of the purposes of MIPS. Additionally, we measures that make up the quality measure to remove the reference to stated that we intended for the measure performance standard. We solicited PCPs. We stated that we believed the to remain double weighted. We comment on how best to conform to the modification in the specifications of proposed to retain the existing EHR intent and spirit of the QPP ACO #11 would be extensive and ECs measure requirements at § 425.506(a)– requirements to ensure that clinicians would also have to gain familiarity with (c) and to modify § 425.506(d) to sunset have assurance they are participating in the reporting requirements under the the current EHR reporting requirement an Advanced APM. We specifically QPP. We therefore proposed that this as discussed in the prior section. solicited comment on our proposals and measure would be considered a newly We also stated that we did not believe the alternatives considered. introduced measure and set at the level that any additional modifications or Furthermore, we noted that the CMS of complete and accurate reporting for exceptions to current Shared Savings Web interface measures, including those the first 2 reporting periods for which Program rules (other than the ones proposed in the QPP proposed rule, are reporting of the measure is required proposed, specifically, that the measure consistent across CMS reporting according to our rules at § 425.502(a)(4). specifications and title of ACO #11 be programs. We stated that we do not Thus, the measure would be pay for modified to include all ECs and not just believe it is beneficial to propose CMS reporting for the 2017 and 2018 PCPs, and the proposal for how an ACO Web interface measures for ACO quality performance years. We further proposed would demonstrate complete and reporting separately. Therefore, to avoid to define requirements specific to this accurate reporting) must be made in confusion and duplicative rulemaking, measure for the limited circumstances order to be consistent with the spirit we proposed that any future changes to in which it is designated as pay for and intent of the statute and the the CMS Web interface measures would reporting. Specifically, we proposed to Advanced APM criteria, as proposed in be proposed and finalized through include the requirement at the QPP proposed rule. Rather, we rulemaking for the QPP, and that such

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changes would be applicable to ACO according to the method of submission CEHRT, we intend to phase in the quality reporting under the Shared established by CMS. Thus, in the QPP measure to pay for performance Savings Program. final rule with comment period, we according to the schedule outlined in The following is a summary of the established a policy that all eligible Table 36 of the proposed rule (81 FR comments we received regarding our clinicians participating in ACOs under 46421–46422) and as indicated in Table proposals to align with QPP. all tracks of the Shared Savings Program 42 of this final rule. Consistent with our Comment: Many commenters were must report for purposes of the established policies for setting quality supportive of our proposed changes to advancing care information performance performance benchmarks for new the title and specifications of the EHR category according to the MIPS measures, a new benchmark for this measure (ACO–11) to align with the requirements found at § 414.1375(b) measure will be set based on the data QPP. In contrast, several commenters regardless of whether they are excluded gathered during the two pay for opposed the proposed modifications to from MIPS for the year by virtue of their reporting years after the measure is the measure or made additional participation in an Advanced APM, in introduced. suggestions. For example, some order for the Shared Savings Program to Comment: One commenter expressed commenters requested that CMS keep assess the ACO’s performance on ACO– concerns over including ECs in the EHR the current version of the measure that 11, as required by the Advanced APM measure who are excluded from MIPS assesses PCPs (not all ECs). Another CEHRT use criterion. and thus have the option of not commenter suggested that CMS assess We appreciate the suggestion that the reporting under the Advancing Care ACOs using two EHR measures. This old measure (based on percent of Information performance category (for commenter recommended keeping the primary care physician use of CEHRT) example, low volume providers and current version of the measure focused be retained in addition to establishing a QPs). They recommended ECs excluded on primary care physicians as pay for new EHR measure that assesses EC use from MIPS be excluded from the performance while adding the modified of CEHRT. We decline to retain the old denominator of ACO–11. version of the measure, which would be measure at this time because the nature Response: As noted above, in the QPP assessed under pay for reporting for 2 of the data being submitted to us is final rule with comment period, we years like all new measures, before changing and primary care physicians established a requirement at transitioning to pay for performance. In are included in the new measure as a § 414.1370(g)(4)) that each ACO contrast, one commenter suggested that subset of the ECs participating in the participant TIN participating in a the EHR measure be removed from the ACO. Although we decline to hold Shared Savings Program ACO ACO measure set entirely. Another ACOs accountable for both measures of (regardless of Track) must submit data commenter suggested that the proposed CEHRT use at this time, we will on the advancing care information modifications to the measure continue to consider whether in the performance category as specified in specifications should apply only to future it would be useful to calculate the MIPS as finalized at § 414.1375(b). ACOs participating in Shared Savings percent of primary care physicians Additionally, it is necessary for ACO Program tracks that could meet the using CEHRT and share this information participant TINs to submit such data to criteria for designation as Advanced with ACOs. APMs under the QPP. Comment: Many commenters meet the requirements under MIPS and Response: We are finalizing the supported the proposal to treat ACO–11 for the calculation of the final score proposal to modify the EHR measures as a new measure and set it at the level under the APM scoring methodology. (ACO–11) to align with the Advanced of pay for reporting for the first 2 years All ECs participating in Track 1 ACOs APM criteria under the QPP. We of its use, consistent with our existing will be subject to MIPS as will ECs appreciate commenters’ support for approach to implementing new participating in ACOs under Tracks 2 these changes. We believe the measures. Other commenters disagreed and 3 that do not qualify as QPs. We modification to ACO–11 to require with the proposal to transition the plan to align closely with the QPP when reporting by all ECs better aligns with measure to pay for performance developing our operational guidance the QPP and will ensure that a subset of according to the phase-in schedule and the measure specifications to ensure ACOs participating in the Shared indicated in Table 36 of the proposed a clear understanding of the data Savings Program are able to qualify to be rule (81 FR 46421–46422) and requested submission requirements for ACO designated as Advanced APM entities that it remain pay for reporting for all participant TINs under MIPS. by participaing in an Advanced APM. 3 years of an ACO’s agreement period. Comment: We received one comment Accordingly, ACO participants in ACOs One commenter encouraged CMS to set supporting our proposal that future under all tracks of the Shared Savings new benchmarks for the new EHR changes to the measures an ACO is Program must report data on the measure. required to report through the CMS Web Advancing Care Information Response: We recognize that reporting Interface be finalized through performance category on behalf of all use of CEHRT under the QPP’s rulemaking for the QPP in order to ECs billing through the TIN of the ACO Advancing Care Information maintain alignment with QPP. participant according to the MIPS performance category according to MIPS Response: We appreciate the support requirements as specified at requirements will be new for many ECs for our proposal. We believe a single § 414.1375(b) in order to report for and that it will take some time for ACOs rulemaking process for adding and purposes of ACO #11. and their ECs to gain some familiarity removing Web interface quality We note that under the QPP final rule with the new reporting requirements for measures will be less confusing for with comment period, eligible clinicians ACO–11. For this reason, we proposed stakeholders and streamline alignment who become QPs by participating in and are finalizing a policy to treat ACO– of ACO and MIPS APM reporting. Advanced APMs will be exempt from 11 as a newly introduced measure and Therefore, we are finalizing our reporting in the advancing care to hold the ACO accountable for pay for proposal that future revisions to the information performance category for reporting only for the first 2 years after Web interface quality measures will be purposes of MIPS. However, under the revised measure is introduced. adopted through rulemaking for the QPP § 425.500(c), ACOs must submit data on However, to stress the importance of to avoid confusion or duplicative ACO quality performance measures care coordination and support the use of rulemaking.

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Comment: Many commenters of EHR adoption will be measured based A beneficiary is eligible for submitted questions or comments on a sliding scale. assignment to an ACO under § 425.402 related to MIPS scoring of the advancing Finally, we are finalizing a policy that if the beneficiary had a primary care care information performance category any future changes to the CMS Web service with a physician who is an ACO and also requested further clarification interface measures will be adopted professional, and thus, is eligible for regarding the CEHRT criteria for through rulemaking for the QPP, and assignment to the ACO under the Advanced APMs. that such changes will be applicable to statutory requirement to base Response: These comments are out of ACO quality reporting under the Shared assignment on utilization of primary the scope of the CY 2017 PFS proposed Savings Program. care services furnished by physicians who are ACO professionals in the ACO. rule. However, we have shared these 4. Incorporating Beneficiary Preference The beneficiary is then assigned to the comments with our colleagues who Into ACO Assignment have responsibility for the QPP. We also ACO if the allowed charges for primary note that the QPP final rule with a. Background care services furnished to the comment period responds to comments Under section 1899(c) of the Act, beneficiary by all primary care received on the QPP proposed rule and beneficiaries are required to be assigned physicians who are ACO professionals further describes the CEHRT criteria for to an ACO participating in the Shared and non-physician ACO professionals in Advanced APMs. Savings Program based on the the ACO are greater than the allowed Final Action: We are finalizing our beneficiary’s utilization of primary care charges for such services provided by policies regarding alignment with the services rendered by physicians primary care physicians, nurse QPP as proposed. Specifically, we are participating in the ACO. Medicare FFS practitioners, physician assistants, and modifying the title and specifications of beneficiaries do not enroll in the Shared clinical nurse specialists who are ACO the EHR quality measure (ACO#11) to Savings Program, and they retain the professionals in another ACO or not align with the QPP. We are changing the right to seek Medicare-covered services affiliated with any ACO and are specifications of the EHR measure in from any Medicare-enrolled provider or identified by a Medicare-enrolled TIN. order to assess the ACO on the degree supplier of their choosing. No The second step of the assignment of CEHRT use by all providers and exclusions or restrictions based on process considers the remainder of suppliers that are participating in the health conditions or similar factors are beneficiaries who have received at least ACO and that are designed as ECs under applied in the assignment of Medicare one primary care service from an ACO the QPP rather than narrowly focusing FFS beneficiaries. Thus, a beneficiary’s physician with a specialty designation on the degree of CEHRT use by the choice to receive primary care services specified in § 425.402(c), but have primary care physicians participating in furnished by physicians and certain received no services from a primary care the ACO. Additionally, as noted above, non-physician practitioners that are physician, nurse practitioner, physician although certain eligible clinicians are ACO professionals in the ACO, assistant, or clinical nurse specialist exempt from reporting under MIPS, we determines the beneficiary’s assignment either inside or outside the ACO. These will require all ACO participant TINs, to an ACO under the Shared Savings beneficiaries are assigned to the ACO if regardless of track, to submit data for Program. As discussed in detail in the the allowed charges for primary care the advancing care information November 2011 Medicare Shared services furnished by physicians who performance category. Savings Program final rule (76 FR 67851 are ACO professionals in the ACO with Because the specifications for this through 67870), we finalized a claims- one of the specialty designations measure are changing, we are finalizing based hybrid approach (called specified in § 425.402(c) are greater than our proposal to consider it a newly preliminary prospective assignment the allowed charges for primary care introduced measure and to set it at the with retrospective reconciliation) for services furnished by physicians with level of complete and accurate reporting assigning beneficiaries to an ACO. such specialty designations in another for the first 2 reporting periods for Under this approach, beneficiaries are ACO or who are not affiliated with any which reporting of the measures is preliminarily assigned to an ACO at the ACO and are identified by a Medicare- required consistent with our existing beginning of a performance year to help enrolled TIN. The ‘‘two step’’ rule at § 425.502(a)(4). Specifically the the ACO refine its care coordination assignment process simultaneously measure will be pay for reporting for all activities, but final beneficiary maintains the requirement to focus on ACOs for the 2017 and 2018 assignment is determined at the end of primary care services in beneficiary performance years. We are also each performance year based on where assignment, while recognizing the finalizing our proposal to include a beneficiaries chose to receive a plurality necessary and appropriate role of requirement at § 425.506(e)(1) that of their primary care services during the specialists and non-physician during years in which ACO #11 is performance year. We adopted this practitioners in providing primary care designated as a pay for reporting policy because we believe that the services, such as in areas with primary measure, in order for us to determine methodology balances beneficiary care physician shortages. We revised that an ACO has met requirements for freedom to choose healthcare providers this two-step claims based methodology complete and accurate reporting, at least under FFS Medicare with the ACO’s in the June 2015 Final Rule as discussed one EC participating in the ACO must desire to have information about the in detail in that final rule (80 FR 32743 meet the reporting requirements under FFS beneficiaries that are likely to be through 32758) and finalized a policy the Advancing Clinical Information assigned at the end of the performance that would exclude services provided by performance category under the QPP. year. We believe this methodology certain physician specialties from step 2 Beginning in the 2019 performance year, accomplishes an appropriate balance of the assignment process. ACO #11 will be assessed according to because ACOs have the greatest Additionally, in the June 2015 final the phase-in schedule noted in Table 42. opportunities to impact the quality and rule, and in response to stakeholders’ We are finalizing our proposal to add cost of the care of beneficiaries that suggestions, we implemented an option § 425.506(e)(2) reiterating our current choose to receive care from providers for ACOs to participate in a new two- requirement at § 425.506(b) that during and suppliers participating in the ACO sided performance-based risk track, pay for performance years, assessment during the course of the year. Track 3. Under Track 3, beneficiaries are

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prospectively assigned to the ACO at the Stakeholders believe that incorporating Provider/Supplier, based on the letters beginning of the performance year using this information and giving beneficiaries they received from Pioneer ACOs. the same two-step methodology, based the opportunity to voluntarily ‘‘align’’ Beneficiaries, for example, were often on the most recent 12 months for which with the ACO in which their primary unfamiliar with the name of the Pioneer data are available, which reflects where healthcare provider participates will ACO. Although most Pioneer ACOs beneficiaries have chosen to receive improve the patient centeredness of the initially expressed high interest in primary care services during that assignment methodology, and possibly beneficiary attestation, only half period. The ACO is held accountable for reduce year-to-year ‘‘churn’’ in participated. Those that did not beneficiaries that are prospectively beneficiary assignment lists. participate cited cost/benefit concerns. assigned to it for the performance year. The Center for Medicare & Medicaid To address concerns expressed by ACOs Under limited circumstances, a Innovation (Innovation Center) began and beneficiaries, the beneficiary beneficiary may be excluded from the conducting a test of beneficiary attestation process was updated for the prospective assignment list, for attestation (which was referred to as Pioneer ACO Model for PY 2016, with voluntary alignment, a term that we will example, if the beneficiary enrolls in letters sent to beneficiaries during the also use in the context of the Shared Medicare Advantage or no longer lives summer of 2015. The new beneficiary Savings Program) in the Pioneer ACO in the United States or U.S. territories attestation process includes updated and possessions, based on the most Model (see https://innovation.cms.gov/ initiatives/Pioneer-aco-model/) for the language in the letters to beneficiaries recent available data in our beneficiary and the attestation form to reduce records at the end of the performance 2015 performance year. In the Pioneer ACO Model, for a Pioneer ACO to beneficiary confusion. The letters now year. A beneficiary is not excluded from include plainer language, refer to a the ACO’s prospective assignment list at participate in voluntary alignment for performance year four (Pioneer ACO specific healthcare provider (in addition the time of reconciliation because the to the ACO), and Pioneer Providers/ beneficiary chose to receive most or all contract year 2015), the Pioneer ACO was required to submit an application to Suppliers are permitted to discuss of his or her primary care during the beneficiary attestation with beneficiaries performance year from providers and CMS in the summer of performance year and respond to questions. Other suppliers outside the ACO. three (Pioneer ACO contract year 2014) significant changes to the process are Additionally, no beneficiaries are added in which the ACO explained its plan for discussed in the proposed rule (81 FR to the ACO’s prospective assignment list contacting beneficiaries. ACOs that were 46432). We would note that for at the time of reconciliation because a approved to participate in voluntary performance year five (Pioneer ACO beneficiary chose to receive a plurality alignment were limited to contacting of his or her primary care during the only those beneficiaries who appeared contract year 2016), CMS changed the performance year from ACO on the ACO’s then current (Pioneer ACO criteria to allow beneficiaries to professionals participating in the ACO. contract year 2014) and prior year’s voluntarily align into the performance Offering this alternative approach to (Pioneer ACO contract year 2013) year five aligned population if, among beneficiary assignment responds to prospective assignment lists. other requirements, the beneficiary had The ACOs sent letters to beneficiaries stakeholders who expressed a desire for at least one paid claim for a Qualified during a specified period asking the a prospective assignment approach. E/M service, as defined in section 2.4 of beneficiaries to confirm whether a listed These stakeholders believe prospective Appendix C of the Pioneer ACO Pioneer Provider/Supplier was their assignment will provide more certainty Agreement, furnished by a Pioneer ‘‘main doctor.’’ The Innovation Center about the beneficiaries for whom the Provider/Supplier on or after January 1, imposed certain safeguards on the 2013. Based on some initial feedback, ACO will be held accountable during participating ACOs to protect against the performance year, thus enabling beneficiaries appear to be wary of the actions that could improperly influence implications of designating a ‘‘main ACOs to redesign their patient care a beneficiary’s decision to complete the processes to more efficiently and doctor’’ but are much more amenable to voluntary alignment form. The ACOs this type of information request when it effectively improve care for specific FFS collected responses and turned them in comes from their physician or other beneficiaries rather than for all FFS to CMS in fall 2014, before the start of practitioner, rather than from an ACO. beneficiaries. We note, however, that the 2015 performance year. However, information is not yet such certainty is limited because Beneficiaries who confirmed a care prospectively aligned beneficiaries who relationship with the Pioneer Provider/ available on the impact or results of the meet the exclusion criteria specified in Supplier listed on the form, and met all modifications made to the beneficiary § 425.401(b) during the performance other eligibility criteria for alignment, attestation process in the Pioneer ACO year will not be aligned to the ACO at were prospectively aligned to the Model. The Next Generation ACO the end of the year; and further, as Pioneer ACO for the upcoming Model, which started operation on noted, beneficiaries remain free under performance year, regardless of whether January 1, 2016, includes a beneficiary FFS Medicare to choose the healthcare or not the practitioners participating in attestation policy similar to the updated providers from whom they receive the Pioneer ACO rendered the plurality manual process used under the Pioneer services. of the beneficiary’s primary care ACO Model. In order for a Medicare FFS Because of uncertainty inherent in services during the alignment period. beneficiary to be eligible to voluntarily FFS Medicare where there is no We refer to the procedures used under align with a Next Generation ACO for beneficiary lock-in or enrollment, both the Pioneer ACO Model as ‘‘the manual performance year two (Next Generation patient advocacy groups and ACOs have process.’’ ACO contract year 2017), the beneficiary expressed interest in and support for Beneficiary and ACO participation in must have had at least one paid claim enhancing claims-based assignment of and experience with voluntary for a qualified evaluation and beneficiaries to ACOs by taking into alignment under the Pioneer ACO management service on or after January account beneficiary attestation regarding Model to date has been mixed. Initially, 1, 2014, with an entity that was a Next the healthcare provider that they beneficiaries often seemed confused Generation Participant during consider to be responsible for about the implications of attesting to a performance year one, among other coordinating their overall care. care relationship with a Pioneer requirements.

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To date, the Innovation Center has also helping to assure that beneficiaries voluntarily aligns with a provider or done limited analyses of the updated are assigned to ACOs based on their supplier whose services would be voluntary alignment process for effects relationship with providers that they considered in assignment but who is not on beneficiary engagement. Early believe to be truly responsible for their participating in an ACO as an ACO experience indicates that for the overall care. However, based on the professional, the beneficiary would not participating ACOs, the number of valuable knowledge and experience we be eligible for alignment to an ACO, prospectively assigned beneficiaries per have gained through these Innovation even if the beneficiary would have ACO increased by 0.2 to 2.7 percent Center models, we also expressed our otherwise been assigned to an ACO relative to the number of beneficiaries concern that the manual voluntary under our claims-based approach. who would have otherwise been alignment process used for the Pioneer We further proposed that, if an assigned. However, there is not yet ACO Model and that is used under the automated voluntary alignment process enough information to determine Next Generation ACO Model is resource is not operationally ready for whether beneficiary attestation under intensive for both ACOs and CMS. implementation by spring 2017, we the manual process has had an impact Because of the limitations of the would implement a manual voluntary on increasing certainty that a manual process, we proposed to alignment process for Track 3 ACOs beneficiary will continue to choose to implement an automated approach only that builds upon experience receive primary care or other services under which we could determine which previously gained under the Pioneer from practitioners participating in an healthcare provider a FFS beneficiary ACO Model. We explained our view ACO. believes is responsible for coordinating that it would be appropriate to initially We note that a similar manual process their overall care (their ‘‘main doctor’’) limit the manual process to ACOs for sending letters to beneficiaries to using information that is collected in an participating in the Shared Savings provide them notice of their opportunity automated and standardized way Program under Track 3 because the to opt out of claims data sharing was directly from beneficiaries (through a process and timing for sending letters to removed from the Shared Savings system established by us, such as beneficiaries regarding voluntary Program in the June 2015 final rule (see MyMedicare.Gov), rather than requiring alignment under the manual process 80 FR 32743). This data sharing opt out individual ACOs, ACO participants, or was developed specifically for process was removed because it was ACO professionals to directly obtain prospective alignment under the resource intensive and cumbersome for this information from beneficiaries Pioneer and Next Generation ACO ACOs and CMS, and was confusing for annually and then communicate these Models and for a limited number of beneficiaries. Instead, based on beneficiary attestations to CMS. ACOs. We indicated that we believe stakeholder comments, we finalized a We proposed to make such an implementing such a manual process for process to provide beneficiaries the automated mechanism available for the hundreds of ACOs in Track 1 and opportunity to decline claims data beneficiaries to voluntarily align with Track 2 whose beneficiaries are sharing directly by contacting the the provider or supplier that they preliminarily prospectively assigned Medicare program (through 1–800– believe is responsible for coordinating with retrospective reconciliation would MEDICARE) rather than through the their overall care starting early in 2017, result in operational challenges for ACO. This more direct process started at making it possible for us to use ACOs and CMS and could have the end of 2015 and so far appears to be beneficiary attestations for assigning unintended consequences that could be working well, as it has not generated the beneficiaries to ACOs in all three tracks confusing or harmful to beneficiaries. number of complaints and concerns for the 2018 performance year. We We therefore proposed that if an raised by the initial manual process. indicated that voluntary alignment data automated process is not available to would be accessed and incorporated in allow beneficiaries to designate their b. Proposals the beneficiary assignment process each primary healthcare provider in time for In the CY 2017 PFS proposed rule, we time we run the assignment algorithm. the information to be considered for proposed to incorporate beneficiary Under the automated approach, beneficiary assignment for PY 2018, we attestation into the assignment of beneficiaries would be able to change would implement an alternative manual beneficiaries to ACOs participating in their attestation about their ‘‘main voluntary alignment process (similar to the Shared Savings Program, to doctor’’ at any time; however, we noted the updated process used under the supplement and enhance the current there may be a lag in using the Pioneer ACO Model and described in claims-based algorithm driven information to update an ACO’s more detail in the CY 2017 PFS methodology as described in more detail assignment list depending on the timing proposed rule) to allow beneficiaries to in this section of the final rule. of the beneficiary’s updated designation align with Track 3 ACOs for the 2018 We indicated that we believed that it and the track under which the ACO is performance year and until such time as would be appropriate to implement, at participating. For example, as described an automated process is available. a minimum, a voluntary alignment in more detail in the CY 2017 PFS Regardless of process (manual or process under the Shared Savings proposed rule, we proposed for Track 3 automatic), we proposed to begin to Program that would be similar to the to incorporate the beneficiary’s incorporate beneficiary attestation into updated manual process we have designation annually prior to the start of the assignment methodology for the implemented under the Pioneer ACO the performance year at the time Shared Savings Program, effective for Model and that is used under the Next beneficiaries are prospectively assigned assignment for the 2018 performance Generation ACO Model. Supplementing for that performance year. year. In brief, under the proposal, an the current claims-based assignment Further, we proposed to incorporate eligible beneficiary would be assigned process with a voluntary alignment voluntary alignment for ACOs in Tracks to an ACO based on the existing claims- process that incorporates beneficiary 1 and 2 on a quarterly basis. We stated based assignment process unless the attestation about their ‘‘main doctor’’ that we believe this policy would be beneficiary has designated a primary could help ACOs to increase patient appropriate because it aligns with the care physician as defined at § 425.20, a engagement, improve care management current timing for updates to Track 1 physician with a specialty designation and health outcomes, and lower and 2 ACO assignment lists. We also included at paragraph (c) of § 425.402, expenditures for beneficiaries, while proposed that if a beneficiary or a nurse practitioner, physician

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assistant, or clinical nurse specialist as on this issue and our proposal under the accurate reflection of the beneficiary’s being responsible for their overall care. automated system to continue to use a wishes and normal care pattern. If an eligible beneficiary has made such beneficiary’s designation of the Examples provided by this commenter a designation then the voluntary healthcare provider responsible for of when the current algorithm could alignment would override the claims- coordinating their overall care until it is lead to inappropriate attribution were in based assignment process if certain changed. cases where a beneficiary is dealing additional conditions are met. We We also welcomed suggestions with an acute illness or condition proposed to revise the regulation regarding the operational process, requiring specialized evaluation and governing the assignment methodology implementation timelines, and related management services, is experiencing to add a new paragraph (e) to § 425.402 issues regarding the process for an extended time away from a primary to address the voluntary alignment beneficiaries to voluntarily align with residence, is a low health care utilizer process. Further, we proposed to an ACO, including how to strengthen where a single service plays a big role prohibit ACOs, ACO participants, ACO ACOs’ beneficiary engagement in determining the plurality of primary providers/suppliers, ACO professionals, activities. We noted that although we care services, or is switching primary and other individuals or entities proposed to establish a process under care physicians when entering a skilled performing functions or services related which beneficiaries may designate their nursing facility (SNF). Commenters to ACO activities from directly or ‘‘main doctor’’ who they consider indicated that allowing beneficiaries to indirectly committing any act or responsible for coordinating their attest to the provider they believe is omission, or adopting any policy that overall care, in establishing the managing their care may also help coerces or otherwise influences a operational processes for allowing increase beneficiary engagement in that Medicare beneficiary’s decision to beneficiaries to designate their ‘‘main care. A number of commenters designate or not designate an ACO doctor’’ we may not explicitly use the expressed support for the proposal to professional as responsible for phrase ‘‘responsible for coordinating exclude from alignment to an ACO any coordinating their overall care. overall care’’ which we included in the beneficiaries who voluntarily align with We stated that to maintain flexibility proposed provision at § 425.402(e). a healthcare provider who is not an for ACOs, ACO participants, ACO Instead, we indicated that we may ACO professional, as that respects the providers/suppliers, ACO professionals, consider using other terminology based beneficiary’s preference. beneficiaries, and CMS, we would on focus group testing and/or other Response: We agree with stakeholders intend to provide further operational feedback from beneficiary that supplementing the current details regarding the voluntary representatives. We welcomed assignment process with a voluntary alignment process and the applicable comments on what terminology would alignment process that incorporates implementation timelines through be preferable to ensure beneficiaries beneficiary attestation could help ACOs subregulatory guidance and other understand the significance of to increase patient engagement, improve outreach activities. designating a provider or supplier as care management and health outcomes, We solicited comments on this responsible for coordinating their and lower expenditures for proposal, on the effective date, and on overall care. We indicated we would beneficiaries. Incorporating beneficiary any other related issues that we should consider such suggestions further as we attestation into the beneficiary consider for the final rule to address develop program guidance and outreach assignment process could further issues related to voluntary alignment activities for beneficiaries and ACOs. strengthen the current claims-based, under the Shared Savings Program. In The following is a summary of the two-step assignment process. particular, we solicited comment on a comments we received regarding Supplementing the claims-based variety of topics such as whether voluntary alignment under the Shared assignment algorithm with beneficiary voluntary alignment is an appropriate Savings Program. attestations could further assure that mechanism for assigning beneficiaries Comment: Commenters supported the beneficiaries are assigned to ACOs retrospectively to an ACO, whether incorporation of voluntary alignment based on their relationship with ACOs should be permitted to opt into or into the Shared Savings Program, citing providers and suppliers that they out of voluntary alignment, and whether the potential for patient engagement and believe to be truly responsible for their we should exclude a beneficiary from an a more stable beneficiary population. overall care. Therefore, we plan to begin ACO’s prospective assignment list for a Commenters indicated that voluntary to incorporate beneficiary attestation performance year if later during the alignment is appropriate for ACOs that into the assignment methodology for the performance year the beneficiary have either retrospective or prospective Shared Savings Program, effective for voluntarily aligns with a healthcare assignment. One commenter indicated assignment for the 2018 performance provider that is not an ACO professional that providing beneficiaries with the year. Based on comments, we will in the ACO. We also solicited input on opportunity to align voluntarily with an incorporate beneficiary attestation as how concerns about ACO avoidance of ACO would balance the important proposed, with certain modifications as at risk beneficiaries might be addressed. considerations of beneficiaries’ freedom discussed in this section. We also noted that under the to choose their providers with ACOs’ Comment: Many of the commenters proposed automated voluntary interest in reducing patient turnover or who supported voluntary alignment alignment process, a beneficiary’s ‘‘churn,’’ thus providing a more defined strongly urged CMS to prioritize designation of a healthcare provider as and stable beneficiary population. The development and timely responsible for coordinating their commenter suggested this would allow implementation of an automated overall care would stay in effect until ACOs to better target their efforts to voluntary alignment process for the beneficiary chose to make a manage and coordinate care for attestation that minimizes the burden subsequent change. We indicated that beneficiaries for whose care they will for beneficiaries and ACOs, and that under the proposal we would rely on ultimately be held accountable. would be accessible to ACOs in all three appropriate information shared with Another commenter suggested there tracks beginning with performance year beneficiaries at the point of care to are many times where for a particular 2018. Some commenters further noted ensure the beneficiary’s designation is year the current claims-based that the process should be automated kept up to date. We solicited comment assignment algorithm may not be an from the beginning even if it were to

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result in a delay in implementation. Response: We believe that the Comment: Some commenters Commenters indicated that using an development and testing of manual expressed support for a quarterly automated approach for voluntary beneficiary attestation processes process to incorporate voluntary alignment would be less burdensome for through the Pioneer ACO Model has alignment for Track 1 and 2 ACOs, and both ACOs and CMS, and would allow been very valuable, and, along with the for keeping beneficiaries who are for more robust participation by ACOs very helpful public comments received prospectively assigned to a Track 3 ACO and beneficiaries. Otherwise, the in response to our proposals, provides a but designate a provider or supplier commenters believe that differences in good foundation for development and outside of the ACO as responsible for how beneficiary attestation is handled implementation of an automated their overall care assigned to the ACO for the three tracks would cause process. Other than our intent to until the end of the benchmark or unnecessary confusion for beneficiaries. determine appropriate terminology performance year. A few other These commenters indicated that the through focus groups and to perform commenters supported the proposal to manual voluntary alignment approach other systems quality assurance testing incorporate the beneficiary attestations used under the Pioneer and Next and the like, we do not believe annually for Track 3 ACOs at the time Generation ACO Models has been very additional testing of the automated beneficiaries are prospectively assigned cumbersome and confusing, and process is needed because it will for a performance year, but for Track 1 therefore, has been pursued by only incorporate the same or similar policies and 2 ACOs, the commenters about one-half of eligible ACOs because as the manual process that has already recommended changes to the proposal of cost/benefit concerns. One undergone testing in Innovation Center to incorporate voluntary alignment on a commenter expressed concern that a models. Therefore, we will prioritize the quarterly basis. For Track 1 and 2 ACOs, manual process would increase the development of procedures to the commenter suggested that only likelihood of errors. implement voluntary alignment using beneficiary attestations made in the Response: We agree with the an automated process with the intent of previous year or the during the first 3 commenters who urge us to prioritize incorporating beneficiary attestations months of the performance year should development and implementation of an into the claims-based assignment be effective for that performance year; automated voluntary alignment process algorithm beginning with the 2018 voluntary alignments made later in the for all three ACO tracks rather than to performance year. We do not intend to performance year would not go into develop concurrently a manual process develop a manual beneficiary attestation effect until the next performance year. limited to Track 3 ACOs that would be process under the Shared Savings The commenter indicated this timing implemented only in the event that an Program. would allow ACOs to identify new automated system for all three Tracks is Comment: A few commenters voluntarily aligned beneficiaries on the not available. We also agree the process suggested that ACOs be permitted to opt quarterly reports beginning with the should be automated from the beginning in or out of the use of beneficiary first or second quarter reports, thus even if it were to result in a delay in designations in assignment. In contrast, enabling the ACO to identify and focus implementation because a manual some other commenters disagreed that efforts on these beneficiaries. The process might increase the likelihood of ACOs should be given this option in commenter indicated this would enable errors, and an automated approach order to ensure all beneficiaries have the ACOs to be able to better target care for would be more efficient for ACOs and opportunity to be aligned with the ACO beneficiaries likely to be retrospectively their ACO participants, ACO providers/ in which the provider or supplier that assigned to the ACO in order to make suppliers, and ACO professionals, as the beneficiary considers responsible for a meaningful difference for the well as for beneficiaries and CMS. Based their overall care participates. performance year. Another commenter on valuable experience gained through Response: We agree with the supported keeping a beneficiary who development and testing of beneficiary commenters who suggested it would be has voluntarily aligned with a Track 1 attestation processes through the inappropriate to permit ACOs to opt or Track 2 ACO assigned to that ACO for Pioneer ACO Model, the manual process into or out of voluntary alignment under the entire performance year, even if the developed thus far appears to be an automated voluntary alignment beneficiary later designates a provider resource intensive for both ACOs and approach. We agree that, to the extent or supplier outside the ACO as CMS and may not significantly impact feasible, all beneficiaries would benefit responsible for their overall care in the beneficiary assignment to ACOs. by being provided with the option of Comment: Some commenters raised designating a healthcare provider middle of the performance year, because concerns regarding the potential burden responsible for their overall care. it would avoid adding confusion in the of a voluntary alignment process Comment: One commenter supported administration of the program. (whether manual or automated) and voluntary alignment, but urged that Similarly, another commenter suggested suggested that further testing be done beneficiary designations only be that variations in the policies regarding prior to implementation. For example, considered, and used to override voluntary alignment by track could lead one commenter suggested testing otherwise applicable assignment rules, to confusion for ACOs and difficulty in voluntary alignment under Track 1 on a for beneficiaries who have been tracking the effect of voluntary small scale to assess whether it impacts assigned to an ACO under the claims- alignment on assignment, and therefore, ACO performance and beneficiary based assignment algorithm. recommended that, for all three tracks, health. Another commenter suggested Response: We disagree. We believe voluntary alignment should be based that voluntary alignment should not be that assignment to ACOs and simply on the most current choice of implemented unless there is a tested beneficiary engagement under the primary care physician at the end of the automated process. One commenter Shared Savings Program would be better performance year. supported the testing of both of the enhanced by taking into account all Another commenter expressed manual and automated models to beneficiary attestations and not just the concerns that voluntary alignment determine which approach presents beneficiary attestations for those who under a retrospective assignment lower burden for providers, CMS, and, would have otherwise been assigned to methodology (Tracks 1 and 2) could most importantly, Medicare an ACO under the claims-based increase adverse incentives for ACOs to beneficiaries. assignment algorithm. selectively encourage some beneficiaries

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to stay aligned to the ACO and others to beneficiaries that have attested to a care another ACO, or to no ACE. Relatedly, leave it. For example, the commenter relationship with an ACO provider/ if a beneficiary designates a practitioner suggested that a beneficiary having a hip supplier to the ACO at the beginning of with a specialty used in assignment and replacement in the next few months each performance year and these the practitioner is not affiliated with an might be inappropriately encouraged to beneficiaries would ‘‘stick’’ on the ACO, then the beneficiary will not be voluntarily align with a healthcare assignment list for the full performance eligible for assignment to an ACO, even provider outside the ACO to avoid year for ACOs under all tracks. In other if the beneficiary would have otherwise having the high cost of a hip words, beneficiaries who voluntarily been assigned to an ACO through replacement included in the ACO’s align to an ACO participating in Track claims-based assignment. expenditures. 1 or Track 2 would be prospectively Finally, we also clarify that consistent Response: We proposed to incorporate assigned to that ACO for the entire with § 425.400(a)(1), the assignment voluntary alignment for ACOs in Tracks performance year even if they would not methodology described under § 425.402 1 and 2 on a quarterly basis because this be retrospectively assigned to the ACO also applies to benchmarking years. approach aligns with the current timing under the claims-based assignment Accordingly, when determining for updates to the assignment lists for methodology or later align with another beneficiary assignment for a benchmark ACOs in Tracks 1 and 2. However, provider or supplier outside the ACO year, we will incorporate beneficiary following further consideration and during the performance year (we note designations that were in place during based on our review of the comments on that in such cases, the change in the assignment window for the benchmarking year. this issue, we now agree with the designation would be taken into account Comment: One commenter supported commenters who indicated that at the beginning of the next performance aligning beneficiaries that choose a incorporating beneficiary attestation less year). In brief, if a beneficiary designates an ‘‘main doctor’’ indefinitely until the frequently under Tracks 1 and 2 could ACO professional that they believe is beneficiary changes his or her help ACOs to better focus their efforts responsible for coordinating their designation, drawing an analogy with to target care for beneficiaries likely to overall care as their ‘‘main doctor’’, the the way beneficiaries who select an MA be assigned to the ACO and make a beneficiary will be assigned to the ACO Plan continue under that MA Plan until meaningful difference for the in which that ACO professional is the beneficiary chooses otherwise. performance year. Further, we believe participating, as long as the ACO Another commenter expressed concern that incorporating beneficiary professional’s specialty is used in that this policy could result in an ACO attestations annually, prior to the assignment and the beneficiary has being inappropriately held responsible beginning of a performance year, for all received at least one primary care for the costs of a beneficiary’s care even three tracks, rather than incorporating service from a physician in that ACO in cases where the ACO no longer has beneficiary attestations quarterly for and does not meet the criteria for a relationship with the beneficiary and Tracks 1 and 2, could be less confusing exclusion. If these criteria are met, the has not furnished services to that for ACOs and beneficiaries. This beneficiary’s selection of his or her beneficiary for years. The commenter timeline aligns with other annual ‘‘main doctor’’ and, ultimately, recommended that voluntary alignment beneficiary election/designation assignment to the ACO would take override the existing assignment processes such as Medicare’s annual precedence over any assignment to an methodology only when a beneficiary enrollment period which would ACO based on claims. For example, if a has at least one qualified primary care simplify our education and outreach beneficiary selects a physician in ACO service during the previous or current efforts. This approach might also at least 1 as his or her main doctor, the performance year with an ACO partially address the commenter’s beneficiary’s designation would take professional that would be considered concern that voluntary alignment under precedence over claims-based under Step 1 or Step 2 of the Shared Tracks 1 and 2 could increase possible assignment, as long as the physician’s Savings Program assignment adverse incentives for ACOs to specialty is used in assignment and the methodology (based on the existing encourage some beneficiaries to stay beneficiary received a primary care services used for Shared Savings aligned to the ACO and others to leave service from a physician in ACO 1. This Program assignment). Another it. We believe such adverse incentives will be the case even if the beneficiary commenter recommended that if the under voluntary alignment for Tracks 1 would have otherwise been assigned to beneficiary does not update their and 2 would be reduced if we were to ACO 2 through claims-based selection annually, reverting to the incorporate beneficiary attestation assignment. claims-based alignment should be the annually, as we proposed for Track 3 However, if a beneficiary designates a default because that will be updated ACOs. Accordingly, we are modifying physician or practitioner in an ACO and regularly as beneficiaries express their our proposed policy in order to take the conditions for assignment are not preference through their healthcare beneficiary attestations into account and met, then the claims-based assignment provider visits. to voluntarily align beneficiaries methodology will be used to determine Response: We continue to believe that annually and prospectively to ACOs the beneficiary’s assignment. For it would be appropriate, under an participating in all tracks at the example, if a beneficiary designates a automated voluntary alignment process, beginning of each performance year, physician in ACO 1, he or she could not for a beneficiary’s designation of a provided the beneficiary is eligible for be assigned to ACO 1 based on the healthcare provider as being responsible assignment to the ACO. Although we attestation if he or she did not receive for coordinating their overall care to assign beneficiaries to ACOs under at least one primary care service from a stay in effect until the beneficiary Tracks 1 and 2 using a preliminary physician in ACO 1. Similarly, if a voluntarily changes his or her prospective with retrospective beneficiary designates an ACO designation. We intend to remind reconciliation approach for purposes of professional in ACO 1 whose services beneficiaries to make a selection and the claims-based assignment are not used in assignment, the claims- update it annually; however, we believe methodology, when incorporating based assignment methodology would it would be burdensome to require beneficiary voluntary alignment be used to determine whether the beneficiaries make this designation each information, we would assign beneficiary will be assigned to ACO 1, year. We also agree that it would be

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inappropriate for an ACO to be held We note that the terms used in the through subregulatory guidance and responsible for the costs of a Innovation Center models have other outreach activities. We anticipate beneficiary’s care in cases where the undergone beneficiary focus group ensuring ACO and practitioner ACO no longer has a relationship with testing. However, we may conduct understanding and compliance with the beneficiary and has not furnished further beneficiary focus group testing if program rules using typical methods, for services to that beneficiary for years. necessary to ensure the terms used are example, through guidance, However, we believe the voluntary appropriate and understandable to programmatic webinars, newsletter alignment policy directly addresses this beneficiaries. articles, email notifications, and concern because, under the proposal, Comment: One commenter communications with the ACO’s beneficiaries that have voluntarily recommended EHR-compatible transfer designated CMS coordinator. We intend aligned with an ACO by designating an of information about beneficiary to monitor beneficiary use of the ACO professional whose services are attestations. voluntary alignment process and the used in assignment as responsible for Response: We are not entirely certain ACO’s compliance with program rules. coordinating their overall care would be what the commenter had in mind, but Comment: One commenter expressed added to the ACO’s list of assigned we believe it is a request that we concerns about using MyMedicare.gov beneficiaries for a performance year or consider building in a method to or 1–800–Medicare as the only avenue benchmark year only if certain electronically alert a practitioner that to collect beneficiary attestations, conditions are met. One of these the beneficiary has designated him or questioning how frequently required conditions is that a beneficiary her as their ‘‘main doctor. We agree that beneficiaries are actively engaging with must have had at least one primary care such a feedback loop could be desirable Medicare through these vehicles. The service with a physician who is an ACO to encourage and enhance the commenter also recommended that the professional in the ACO and who is a relationship beneficiaries have with designation of a ‘‘main doctor’’ should primary care physician as defined under their practitioners. In the future we may be independent of the ‘‘favorites’’ § 425.20 or who has one of the primary consider such possibilities but at this indication in MyMedicare.gov, specialty designations included in time we plan to prioritize development suggesting that being designated as a § 425.402(c). In this final rule, we are and implementation of an automated ‘‘favorite’’ is not a good indicator of amending the proposed regulations text voluntary alignment process within being a ‘‘main doctor’’. at § 425.402(e)(2)(i) to clarify that in MyMedicare.gov, as discussed in this Response: The operational process for order for a beneficiary to be eligible for section. beneficiaries to voluntarily align with assignment under voluntary alignment Comment: Several commenters an ACO by designating a ‘‘main doctor’’ this service must have been received requested more detail regarding the or primary healthcare provider during the ‘‘assignment window’’ for the process and timing for beneficiaries to responsible for coordinating their applicable benchmark or performance designate their ‘‘main doctor’’ and how overall care will be incorporated into year as defined at § 425.20. This ACOs would be educated about the existing processes to the extent feasible. requirement will ensure that a voluntary alignment process and As we indicated in the proposed rule, beneficiary cannot remain aligned to an applicable program requirements. examples by which such a process ACO for an extended period if the Response: We will notify beneficiaries could be automated include using beneficiary’s designation is outdated of this opportunity and encourage them MyMedicare.gov, 1–800–Medicare, or and the beneficiary is no longer to designate their ‘‘main doctor’’ or Physician Compare. We anticipate that receiving services from any ACO primary healthcare provider responsible for the first year of the automated providers/suppliers in the ACO. for coordinating their overall care and process, we will enable beneficiaries to Comment: Several commenters raised explain how to do this through voluntarily align with an ACO by specific concerns over the use of certain beneficiary outreach materials such as designating a ‘‘main doctor’’ or primary phrases such as ‘‘main doctor’’ and through the Medicare & You Handbook healthcare provider responsible for recommended testing such terminology (see https://www.medicare.gov/ coordinating their overall care through with beneficiaries through focus groups medicare-and-you/medicare-and- MyMedicare.gov. Beneficiaries or their or other methods. For example, some you.html), the required Shared Savings representatives that call 1–800– commenters believe the term ‘‘main Program notifications under § 425.312, Medicare during the early doctor’’ is too ambiguous. Other and/or other beneficiary outreach implementation of the automated commenters requested that CMS revise activities or materials. We intend to voluntary alignment process in order to physician-centric language such as issue, either directly or indirectly designate a ‘‘main doctor’’ or primary ‘‘main doctor’’ to avoid through template language (for example, healthcare provider will be provided miscommunication given that certain template language that would be with information about how to make the non-physician practitioners are also incorporated into the ACO’s required designation in MyMedicare.gov. included in the assignment process. A written notifications under § 425.312), Subsequently, we plan to consider commenter suggested that CMS should written communications to beneficiaries expanding the use of 1–800–Medicare as also work with other payers to align detailing the automated process for a way for beneficiaries to make a terms. voluntary alignment. The designation designation and in order to provide Response: We appreciate receiving the must be made in the form and manner additional avenues or technical helpful comments regarding what and by a deadline determined by CMS. assistance to support beneficiaries in terminology would be preferable to Additionally, as noted above, in the making a designation. As we and our ensure beneficiaries understand the proposed rule we stated that to maintain stakeholders gain experience with the significance of designating a provider or flexibility for ACOs, ACO participants, automated process, we intend to supplier as responsible for coordinating ACO providers/suppliers, ACO continue to refine and build upon the their overall care. We will consider professionals, beneficiaries, and CMS, automated process. More information these suggestions further as we we would intend to provide further will be forthcoming as we gather implement voluntary alignment and operational details regarding the additional input from beneficiaries, develop program guidance and outreach voluntary alignment process and the ACOs, and other stakeholders. We agree activities for beneficiaries and ACOs. applicable implementation timelines that designating ‘‘favorite’’ providers is

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not the same as designating a ‘‘main because this approach better aligns with accidentally selecting doctors with doctor’’ and that these two things ACO-level accountability and avoids similar names, for example. should be independent. some of the confusion over ‘‘main Response: We agree this information Comment: A few commenters doctor.’’ Another commenter suggested could be useful for beneficiaries. This is suggested beneficiaries also be offered beneficiaries should be provided a feature that already exists in the opportunity to attest in person, information about the process for MyMedicare.gov where beneficiaries during a visit to an ACO provider/ opting-out of alignment with an ACO. can access their claims information supplier, if that is their preference. Response: Our experience with the which includes information such as the Response: We are not providing an Pioneer ACO Model indicates that name of the practitioner that submitted option for beneficiaries to attest in beneficiaries are less likely to identify the claim. We note this information can person during a visit with an ACO with an ACO as compared to an be used currently to build the provider/supplier or other healthcare individual healthcare provider; that is, beneficiary’s ‘‘favorites’’ list. Similarly, provider because we are concerned that when given the option, beneficiaries are the beneficiary could use the such an option would lead to additional more likely to align with their information to assist in making their program complexity and could defeat practitioner, not with an organization. ‘‘main doctor’’ designation. the purpose of having an automated Accordingly, we continue to believe it is Comment: A commenter suggested an process that is designed to relieve appropriate under an automated system alternative approach for assigning stakeholder burden experienced when for beneficiaries to be given the option beneficiaries to ACOs using claims such designations are made manually to voluntarily align with an individual submitted by providers and suppliers made at the point of care. However, as healthcare provider rather than to an using only the codes for initial Medicare noted above in this section, we plan to ACO with which the beneficiary may visits, annual wellness visits, chronic provide written educational material not be familiar. For the same reason, we care management, and advanced care and template language that ACOs and do not believe it is necessary or planning; the commenter believed this healthcare providers can use at the appropriate to give beneficiaries the alternative approach would be less point of care to inform and educate option of ‘‘opting out’’ of assignment to cumbersome for CMS to administer and beneficiaries about the ability to an ACO. The intent of the voluntary a simpler and more streamlined designate a healthcare provider in alignment process is to seek to improve approach for beneficiaries and the MyMedicare.gov as responsible for the beneficiary engagement with a selected primary care physician. beneficiary’s overall care. practitioner that he/she designates as Response: We will continue to Comment: Other commenters being responsible for his/her overall consider suggestions that might further questioned whether seniors would keep care, regardless of whether the improve the beneficiary assignment their ‘‘main doctor’’ attestation up to practitioner is participating in an ACO. methodology. However, we are giving date given their varied and often Comment: One commenter priority to supplementing the current unpredictable care needs, and therefore, recommended information be provided claims-based assignment process with a asked that CMS explicitly allow to an ACO as soon as the attestation is voluntary alignment process that physicians and other appropriately updated within the CMS designated incorporates beneficiary attestation qualified individuals involved with system when one of its assigned about their ‘‘main doctor’’ which we patient care to assist beneficiaries in beneficiaries designates a new ‘‘main believe will more directly help ACOs to keeping their ‘‘main doctor’’ attestation doctor.’’ The commenter believed this increase patient engagement, improve up to date. notification would allow ACOs time to care management and health outcomes, Response: We believe it is important make any updates to their management and lower expenditures for to promote engagement and discussion of their ‘‘participation programs’’ and beneficiaries. The process may also be between beneficiaries and their properly manage their patient advantageous for beneficiaries by healthcare providers. ACOs, ACO populations, and it would give them improving engagement between the participants, ACO providers/suppliers, guidance on how to set up for their next beneficiary and the practitioner they and ACO professionals may provide a performance year. believe is primarily responsible for their beneficiary with accurate descriptive Response: We are considering overall care. information about the potential patient possible ways of notifying ACOs that a Comment: A commenter suggested care benefits of designating an ACO beneficiary has designated one of their CMS provide incentives for professional as responsible for the ACO providers/suppliers as their ‘‘main beneficiaries who designate an ACO beneficiary’s overall care. However, we doctor;’’ however, we note that the professional within the ACO. do not intend for the voluntary under the modified policy we are Response: We are unclear as to what alignment process to be used as a adopting in this final rule, ACOs in all incentives this commenter was mechanism for ACOs (or their ACO tracks will have advanced notice when suggesting but we would note that we participants, ACO providers/suppliers, a beneficiary is assigned to them based do not believe we have authority under ACO professionals or other individuals on the voluntary alignment the Shared Savings Program to provide or entities performing functions or methodology because such beneficiaries incentives for beneficiaries who services on behalf of the ACO) to target will be prospectively assigned to the designate an ACO professional within beneficiaries for whose treatment the ACO for that performance year and will the ACO as their ‘‘main doctor.’’ ACO might expect to earn shared appear on the ACO’s assignment list at Further, the ACO, ACO participants, savings, or to avoid those for whose the beginning of the performance year. ACO providers/suppliers, ACO treatment the ACO might be less likely Comment: A commenter suggested professionals, and other individuals and to generate shared savings. CMS should provide beneficiaries with entities performing functions and Comment: One commenter a list of providers that they have seen services related to ACO activities are recommended that rather than asking recently (based on claims) to simplify prohibited from providing or offering beneficiaries to designate a specific their selection and help them accurately gifts or other remuneration to Medicare doctor, that they be asked to designate select their ‘‘main doctor.’’ The beneficiaries as inducements to the ACO they generally identify as commenter believed this approach influence a Medicare beneficiary’s where they receive health services would mitigate the risk of beneficiaries decision to designate or not designate an

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ACO professional as responsible for beginning with the 2018 performance § 425.20 of this part, a physician with a coordinating their overall care. year. If an automated system is not specialty designation included at Comment: We received several available during the assignment window § 425.402(c) of this subpart, or a nurse comments supporting the proposals to for the 2018 performance year, then practitioner, physician assistant, or prohibit ACOs from directly or voluntary alignment would not be used clinical nurse specialist as responsible indirectly influencing a Medicare for performance year 2018. for their overall care. beneficiary’s decision to designate or • We are modifying our proposed • The designation must be made in not designate an ACO professional as policy to incorporate new or revised the form and manner and by a deadline responsible for coordinating their beneficiary attestations and align such determined by CMS. overall care. The commenters indicated beneficiaries to ACOs in Tracks 1 and 2 In contrast, if a beneficiary designates this could help ensure that ACOs do not on a quarterly basis and instead will a provider or supplier outside the ACO, ‘‘cherry-pick’’ the healthiest patients or incorporate these updates and align who is a primary care physician as ‘‘lemon-drop’’ patients with certain such beneficiaries prospectively for all defined at § 425.20 of this part, a complex, costly diseases. Some tracks at the beginning of each physician with a specialty designation commenters also urged CMS to put in performance and benchmark year, included at § 425.402(c), or a nurse place mechanisms to monitor the provided the beneficiary is eligible for practitioner, physician assistant, or impact of voluntary alignment on the assignment to the ACO in which their clinical nurse specialist, as responsible composition of ACOs’ assigned designated ‘‘main doctor’’ is for coordinating their overall care, the beneficiary populations, especially with participating. beneficiary will not be added to the regard to any changes in the prevalence • We are modifying § 425.402, ACO’s list of assigned beneficiaries for of patients with certain complex, costly paragraph (b), by removing the phrase a performance year or benchmark year, diseases within a specific ACO. ‘‘beneficiaries to an ACO:’’ and adding even if the beneficiary would otherwise Response: We intend to monitor the in its place the phrase ‘‘beneficiaries to be included in the ACO’s assigned implementation of voluntary alignment. an ACO based on available claims beneficiary population under the As noted above in this section, we information.’’ This revision is necessary assignment methodology in emphasize that we do not intend for the to ensure understanding that the § 425.402(b). voluntary alignment process to be used procedure described under paragraph Further, we are finalizing our as a mechanism for ACOs (or their ACO (b) is based on claims data, not on other proposal that the ACO and its ACO participants, ACO providers/suppliers, data that may be available (such as participants, ACO providers/suppliers, ACO professionals or other individuals voluntary alignment data). ACO professionals, and other or entities performing functions or We are also revising the regulations individuals or entities performing services on behalf of the ACO) to target governing the assignment methodology functions or services related to ACO beneficiaries for whose treatment the to amend § 425.402(b) and add a new activities are prohibited from providing ACO might expect to earn shared paragraph (e) to § 425.402. Beginning in or offering gifts or other remuneration to savings, or to avoid those for whose performance year 2018, if a system is Medicare beneficiaries as inducements treatment the ACO might be less likely available to allow beneficiaries to to influence a Medicare beneficiary’s to generate shared savings. However, we designate a provider or supplier as decision to designate or not designate an believe it is important to promote responsible for coordinating their ACO professional under § 425.402(e). engagement and discussion between overall care and for CMS to process the The ACO, ACO participants, ACO beneficiaries and their healthcare designation electronically, beneficiaries providers/suppliers, ACO professionals, providers. Therefore ACOs, ACO that have voluntarily aligned with an and other individuals or entities participants, ACO providers/suppliers, ACO by designating an ACO performing functions or services related and ACO professionals are not professional whose services are used in to ACO activities must not directly or prohibited from providing a beneficiary assignment as responsible for indirectly, commit any act or omission, with accurate descriptive information coordinating their overall care will be nor adopt any policy that coerces or about the potential patient care benefits added to the ACO’s list of assigned otherwise influences a Medicare of designating an ACO professional as beneficiaries, for a benchmark or beneficiary’s decision to designate or responsible for the beneficiary’s overall performance year under the following not designate an ACO professional as care. conditions: responsible for coordinating their Final Action: We are finalizing our • The beneficiary must have had at overall care, including but not limited to proposal to incorporate beneficiary least one primary care service during the following: preference into ACO assignment as the assignment window as defined • Offering anything of value to the proposed with two modifications as under § 425.20 with a physician who is Medicare beneficiary as an inducement noted above. In addition, we are making an ACO professional in the ACO and to influence the Medicare beneficiary’s a minor editorial revision to paragraph who is a primary care physician as decision to designate or not to designate (b) of § 425.402 in order to more clearly defined under § 425.20 of this subpart or an ACO professional as responsible for identify beneficiaries assigned by the who has one of the primary specialty coordinating their overall care. Any claims-based assignment methodology. designations included in § 425.402(c). items or services provided in violation • We no longer intend to develop a • The beneficiary must meet the of this prohibition will not be manual voluntary alignment process as assignment eligibility criteria considered to have a reasonable an alternative for ACOs participating in established in § 425.401(a), and must connection to the medical care of the Track 3 in the event an automated not be excluded by the criteria at beneficiary, as required under process is not ready for performance § 425.401(b). Such exclusion criteria § 425.304(a)(2). year 2018, and instead will focus on shall apply to all tracks for purposes of • Withholding or threatening to developing and implementing an alignment based on beneficiary withhold medical services or limiting or automated voluntary alignment process designation information. threatening to limit access to care. with the intent of incorporating • The beneficiary must have We will provide further operational beneficiary designations into the current designated an ACO professional who is details regarding the voluntary claims-based assignment algorithm a primary care physician as defined at alignment process and the applicable

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implementation timelines through methodology used in Track 3, receive covered SNF services under the subregulatory guidance and other beneficiaries are assigned in advance to waiver prior to admission; remedial outreach activities. the ACO for the entire performance year processes and penalties for (unless they meet any of the exclusion noncompliance with the terms of the 3. SNF 3-Day Rule Waiver Beneficiary criteria under § 425.401(b) during the waiver, and other requirements set forth Protections performance year), so it will be clearer at § 425.612(a)(1)(iii). The SNF affiliate a. Background to a Track 3 ACO whether the waiver agreement must include these elements The Medicare SNF benefit is for applies to SNF services furnished to a to ensure that the SNF affiliate beneficiaries who require a short-term particular beneficiary than it would be understands its responsibilities related intensive stay in a SNF, requiring to an ACO in Track 1 or 2, where to implementation of the SNF 3-day rule skilled nursing, or skilled rehabilitation beneficiaries are assigned using a waiver. care, or both. Under section 1861(i) of preliminary prospective assignment We indicated in the June 2015 final the Act, beneficiaries must have a prior methodology with retrospective rule that the SNF 3-day rule waiver would be effective no earlier than inpatient hospital stay of no fewer than reconciliation (80 FR 32804). An ACO’s January 1, 2017; thereafter, the waiver 3 consecutive days in order to be use of the SNF 3-day rule waiver will be will be effective upon CMS notification eligible for Medicare coverage of associated with a distinct and easily to the ACO of approval for the waiver inpatient SNF care. In the June 2015 identifiable event, specifically, or the start date of the ACO’s final rule (80 FR 32804 through 32806), admission of a prospectively assigned participation agreement, whichever is we provided ACOs participating in beneficiary to a previously identified later, and will not extend beyond the Track 3 with additional flexibility to SNF affiliate without prior inpatient hospitalization or after an inpatient term of the ACO’s participation attempt to increase quality and decrease hospitalization of fewer than 3 days. agreement. costs by allowing these ACOs to apply Based on our experiences under the We also indicated in the June 2015 for a waiver of the SNF 3-day rule for Pioneer ACO Model, and in response to final rule that we established the their prospectively assigned comments, we established certain timeline for implementation of the SNF beneficiaries when they are admitted to requirements under § 425.612 for ACOs, 3-day rule waiver to allow for certain ‘‘SNF affiliates,’’ that is, SNFs ACO providers/suppliers, SNF affiliates, development of additional with whom the ACO has executed SNF and beneficiaries with respect to the subregulatory guidance, including affiliate agreements. (See SNF 3-day rule waiver under the Shared necessary education and outreach for § 425.612(a)(1)). Waivers are effective Savings Program. All ACOs electing to ACOs, ACO participants, ACO upon CMS notification of approval for participate in Track 3 will be offered the providers/suppliers, and SNF affiliates. the waiver or the start date of the ACO’s opportunity to apply for a waiver of the We noted that we would continue to participation agreement, whichever is SNF 3-day rule for their prospectively evaluate the waiver of the SNF 3-day later. (See § 425.612(c)). We stated in the assigned beneficiaries at the time of rule, including further lessons learned June 2015 final rule that the SNF 3-day their initial application to participate in from Innovation Center models in rule waiver would be effective for Track 3 of the program and annually which a waiver of the SNF 3-day rule services furnished on or after January 1, thereafter while participating in Track 3. is being tested. We indicated that in the 2017. Program requirements for this We began accepting the first SNF 3-day event we determined that additional waiver are codified at § 425.612. These rule waiver applications from Track 3 safeguards or protections for requirements are primarily based on ACOs this past summer. beneficiaries or other changes were criteria previously developed under the To be eligible to receive covered necessary, such as to incorporate Pioneer ACO Model. Specifically, under services under the SNF 3-day rule additional protections for beneficiaries § 425.612(a)(1), we waive the waiver, a beneficiary must be into the ACO’s participation agreement requirement in section 1861(i) of the Act prospectively assigned to the ACO for or SNF affiliate agreements, we would for a 3-day inpatient hospital stay prior the performance year in which he or she propose the necessary changes through to a Medicare covered post-hospital is admitted to the SNF affiliate, may not future rulemaking. extended care service for eligible reside in a SNF or other long-term care In considering additional beneficiary beneficiaries prospectively assigned to setting, must be medically stable and protections that may be necessary to ACOs participating in Track 3 that have have an identified skilled nursing or ensure proper use of the SNF 3-day rule been approved to implement the waiver rehabilitation need that cannot be waiver under the Shared Savings that receive otherwise covered post- provided as an outpatient, and must Program, we note that there are existing, hospital extended care services meet the other requirements set forth at well established payment and coverage furnished by an eligible SNF that has § 425.612(a)(1)(ii). policies for SNF services based on entered into a written agreement to For a SNF to be eligible to partner sections 1861(i), 1862(a)(1), and 1879 of partner with the ACO for purposes of with ACOs for purposes of the waiver, the Act that include protections for this waiver. All other provisions of the the SNF must have an overall quality beneficiaries from liability for certain statute and regulations regarding rating of 3 or more stars under the CMS non-covered SNF charges. These Medicare Part A post-hospital extended 5 Star Quality Rating System, and must existing payment and coverage policies care services continue to apply. sign a written agreement with the ACO, for SNF services continue to apply to We believe that clarity regarding which we refer to as the ‘‘SNF affiliate SNF services furnished to beneficiaries whether a waiver applies to SNF agreement,’’ that includes elements assigned to ACOs participating in the services furnished to a particular determined by CMS, including: A clear Shared Savings Program, including beneficiary is important to help ensure indication of the effective dates of the services furnished pursuant to the SNF compliance with the conditions of the SNF affiliate agreement; agreement to 3-day rule waiver. (For example, see the waiver and also improve our ability to comply with Shared Savings Program Medicare Claims Processing Manual, monitor waivers for misuse. Therefore, rules, including but not limited to those Chapter 30—Financial Liability in the June 2015 final rule, we limited specified in the participation agreement Protections, section 70, available at the waiver to ACOs in Track 3 because between the ACO and CMS; agreement https://www.cms.gov/Regulations-and- under the prospective assignment to validate beneficiary eligibility to Guidance/Guidance/Manuals/

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Downloads/clm104c30.pdf; Medicare longer eligible to be assigned to the that functionally acts as an extension of Coverage of Skilled Nursing Facility ACO. As a result, the beneficiary would beneficiary eligibility for the SNF 3-day Care beneficiary booklet, Section 6: be excluded from the ACO’s prospective rule waiver and permits some additional Your Rights & Protections, available at assignment list because the beneficiary time for the ACO to receive quarterly https://www.medicare.gov/Pubs/pdf/ meets one or more of the exclusion exclusions lists from CMS and 10153.pdf; and Medicare Benefit Policy criteria specified at § 425.401(b). That is, communicate beneficiary exclusions to Manual, Chapter 8—Coverage of although SNF services are covered its SNF affiliates. In the proposed rule, Extended Care (SNF) Services Under under Part A, not Part B, the beneficiary we stated that we believe it would be Hospital Insurance available at https:// would be dropped from the ACO’s appropriate, in order to protect www.cms.gov/Regulations-and- prospective assignment list if during the beneficiaries from potential financial Guidance/Guidance/Manuals/ performance year the beneficiary is no liability related to the SNF 3-day rule downloads/bp102c08.pdf). In general, longer enrolled in Part B and thus no waiver under the Shared Savings CMS requires that the SNF inform a longer eligible to be assigned to the Program, to establish a similar 90-day beneficiary in writing about services ACO. We are concerned about some grace period in the case of a beneficiary and fees before the beneficiary is very limited situations, such as when a who was prospectively assigned to a admitted to the SNF (§ 483.10(b)(6)); the beneficiary’s Part B coverage terminates waiver-approved ACO at the beginning beneficiary cannot be charged by the during a quarter when the beneficiary is of the performance year but is later SNF for items or services that were not also receiving SNF services. The excluded from assignment to the ACO. requested (§ 483.10(c)(8)(iii)(A)); a beneficiary may be admitted to a SNF Therefore, we explained that we beneficiary cannot be required to without a prior 3-day inpatient hospital believe it is necessary for purposes of request extra services as a condition of stay after his or her Part B coverage carrying out the Shared Savings continued stay (§ 483.10(c)(8)(iii)(B)); ended, but before the beneficiary Program to allow formerly assigned and the SNF must inform a beneficiary appears on a quarterly exclusion list. It beneficiaries to receive covered SNF that requests an item or service for is not operationally feasible for CMS to services under the SNF 3-day rule which a charge will be made that there notify the ACO and for the ACO, in waiver when the beneficiary is admitted will be a charge for the item or service turn, to notify its SNF affiliates, ACO to a SNF affiliate within a 90-day grace and what the charge will be participants, and ACO providers/ period following the date that CMS (§ 483.10(c)(8)(iii)(C)). (See also section suppliers immediately of the delivers the quarterly beneficiary 6 of Medicare Coverage of Skilled beneficiary’s exclusion. The lag in exclusion list to an ACO. The equitable Nursing Facility Care at https:// communication may then cause the SNF and efficient implementation of the SNF www.medicare.gov/Pubs/pdf/ affiliate to unknowingly admit a 3-day rule waiver is necessary to further 10153.pdf.) beneficiary who no longer qualifies for support ACOs’ efforts to increase quality b. Proposals the waiver without a prior 3-day and decrease costs under two-sided inpatient hospital stay. Absent specific Since publication of the June 2015 performance-based risk arrangements. beneficiary protections, we are final rule, we have continued to learn (See 80 FR 32804 for a detailed concerned that the beneficiary could be from implementation and refinement of discussion of the rationale for charged for such non-covered SNF the SNF 3-day rule waiver in the establishing the SNF 3-day rule waiver.) services. We do not believe it would be Pioneer ACO Model (see https:// Based upon the experience in the innovation.cms.gov/initiatives/Pioneer- appropriate for CMS to hold the Pioneer ACO Model, we believe it is not aco-model/) and the Next Generation beneficiary or the SNF affiliate possible to adopt such a waiver without ACO Model (see https:// financially liable for such services. We providing some protection for certain innovation.cms.gov/initiatives/Next- believe we should allow for a reasonable beneficiaries who were prospectively Generation-ACO-Model). Based on these amount of time for CMS to assigned to the ACO at the start of the experiences, we indicated in the communicate beneficiary exclusions to year, but are subsequently excluded proposed rule that we believe there are an ACO and for the ACO to from assignment. Accordingly, we situations where it would be communicate the exclusions to its SNF proposed to modify the waiver to appropriate to require additional affiliates, ACO participants, and ACO include a 90-day grace period to allow beneficiary financial protections under providers/suppliers. Typically there sufficient time for CMS to notify the the SNF 3-day rule waiver for the would be no way for the SNF affiliate ACO of any beneficiary exclusions, and Shared Savings Program. Specifically, to verify in real-time that a beneficiary for the ACO then to inform its SNF we are concerned about potential continues to be prospectively assigned affiliates, ACO participants, and ACO beneficiary financial liability for non- to the ACO; the SNF affiliate must rely providers/suppliers of those exclusions. covered Part A SNF services that might upon the assignment list and quarterly More specifically, we proposed to be directly related to use of the SNF 3- exclusion lists provided by CMS to the modify the waiver under § 425.612(a)(1) day rule waiver under the Shared ACO and communicated by the ACO to to include a 90-day grace period that Savings Program. its SNF affiliates, ACO participants, and would permit payment for SNF services First, one example of a scenario under ACO providers/suppliers. Further, the provided to beneficiaries who were which a beneficiary may be at financial beneficiary does not receive a initially on the ACO’s prospective risk relates to the quarterly exclusions notification regarding his or her assignment list for a performance year from a Track 3 ACO’s prospective eligibility for the SNF 3-day rule waiver but were subsequently excluded during assignment list. For example, assume a prior to receiving SNF services under the performance year. CMS would make beneficiary was prospectively assigned the waiver, so beneficiaries are not able payments for SNF services furnished to to a Track 3 ACO that has been to check their own eligibility. such a beneficiary under the terms of approved for the SNF 3-day rule waiver To address delays in communicating the SNF 3-day rule waiver if the (a waiver-approved ACO), but during beneficiary exclusions from the following conditions are met: the first quarter of the year, the prospective assignment list, the Pioneer • The beneficiary was prospectively beneficiary’s Part B coverage terminated ACO Model and Next Generation ACO assigned to a waiver-approved ACO at and the beneficiary is therefore no Model provide for a 90-day grace period the beginning of the performance year

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but was excluded in the most recent inpatient hospital stay. We are propose to adopt a similar policy under quarterly exclusion list. concerned that, once the claim is the Shared Savings Program because, • The SNF affiliate services are rejected, the beneficiary may not be under § 425.612(a)(1)(iii)(B), to be a SNF furnished to a beneficiary admitted to protected from financial liability, and affiliate, a SNF must agree to validate the SNF affiliate within 90 days thus could be charged by the SNF the eligibility of a beneficiary to receive following the date that we deliver the affiliate for these non-covered SNF covered SNF services in accordance quarterly exclusion list to the ACO. services that were a result of an with the waiver prior to admission to • We would have otherwise made inappropriate attempt to use the waiver, the SNF, and otherwise comply with the payment to the SNF affiliate for the potentially subjecting the beneficiary to requirements and conditions of the services under the SNF 3-day rule significant financial liability. However, Shared Savings Program. SNF affiliates waiver, but for the beneficiary’s in this scenario, a SNF with a are required to be familiar with the SNF exclusion from the waiver-approved relationship to the ACO submitted the 3-day rule and the terms and conditions ACO’s prospective assignment list. claim that was rejected for lack of a of the SNF 3-day rule waiver for the We further noted that we anticipate qualifying inpatient hospital stay, but Shared Savings Program, and should that there would be very few instances that otherwise would have been paid by know to verify that a FFS Medicare where it would be appropriate for SNF Medicare. In this circumstance, we beneficiary who is a candidate for services to qualify for payment under proposed to assume the SNF’s intent admission has completed a qualifying this 90-day grace period. This is because was to rely upon the SNF 3-day rule hospital stay or that the admission this waiver only allows for payment for waiver, but the waiver requirements meets the criteria under a waiver of the claims that meet all applicable were not met. We believe it is SNF 3-day rule that is properly in place. requirements except the requirement for reasonable to assume the SNF’s intent Additionally, ACOs and their SNF a prior 3-day inpatient hospital stay. For was to use the SNF 3-day rule waiver affiliates are required to develop plans example, assume that a beneficiary who because, as a SNF affiliate, the SNF that will govern communication and had been assigned to a waiver-approved should be well aware of the ability to beneficiary evaluation and admission ACO was admitted to a SNF without a use the SNF 3-day rule waiver and, by prior to use of the SNF 3-day rule prior 3-day inpatient hospital stay after submitting the claim, demonstrated an waiver. In these circumstances, we his or her enrollment in an MA Plan, expectation that CMS would pay for believe it is reasonable that the ultimate but before the beneficiary appears on a SNF services that would otherwise have responsibility and liability for a non- quarterly exclusion list. In this case, been rejected for lack of a 3-day covered SNF admission should rest with these SNF services would not be inpatient hospital stay. We believe that the admitting SNF affiliate. covered under FFS because the waiver in this scenario, the rejection of the does not expand coverage to include Therefore, to protect FFS beneficiaries claim under the SNF 3-day rule waiver services furnished to Medicare from being charged in certain could easily have been avoided if the beneficiaries enrolled in MA Plans. Both circumstances for non-covered SNF ACO, the admitting ACO provider/ beneficiaries and healthcare providers services related to the waiver of the SNF are expected to know that the supplier, and the SNF affiliate had 3-day rule under the Shared Savings beneficiary is covered under an MA confirmed that the requirements for use Program, potentially subjecting such plan and not FFS Medicare. of the SNF 3-day rule waiver were beneficiaries to significant financial Second, we are concerned that there satisfied. Because each of these entities liability, we proposed to add certain could be other more likely scenarios is in a better position to know the beneficiary protection requirements in where a beneficiary could be charged for requirements of the waiver and ensure § 425.612(a)(1). These requirements non-covered SNF services that were a that they are met than the beneficiary is, would apply to SNF services furnished result of an ACO’s or SNF’s we believe that the ACO and/or the SNF by a SNF affiliate that would otherwise inappropriate use of the SNF 3-day rule affiliate should be accountable for such have been covered except for the lack of waiver. Specifically, we are concerned rejections and the SNF affiliate should a qualifying hospital stay preceding the that a beneficiary could be charged for be prevented from attempting to charge admission to the SNF affiliate. non-covered SNF services if a SNF the beneficiary for the non-covered SNF Specifically, we proposed that we affiliate were to admit a FFS beneficiary stay. would make no payment to the SNF, who is not prospectively assigned to the To address situations similar to this and the SNF may not charge the waiver-approved ACO, and payment for scenario where the beneficiary may be beneficiary for the non-covered SNF SNF services is denied for lack of a subject to financial liability due to an services, in the event that a SNF that is qualifying inpatient hospital stay. eligible SNF submitting a claim that is a SNF affiliate of a Track 3 ACO that has We believe this situation could occur not paid only as a result of the lack of been approved for the SNF 3-day rule as a result of a breakdown in one or a qualifying inpatient hospital stay, the waiver admits a FFS beneficiary who more of processes the ACO and SNF Next Generation ACO Model generally was never prospectively assigned to the affiliate are required to have in place to places the financial responsibility on waiver-approved ACO (or was assigned implement the waiver. For example, the the SNF, where the SNF knew or but later excluded and the 90 day grace SNF affiliate and the admitting ACO reasonably could be expected to have period has lapsed), and the claim is provider/supplier may not verify that known that payment would not be made rejected only for lack of a qualifying the beneficiary appears on the ACO’s for the non-covered SNF services. In inpatient hospital stay. prospective assignment list prior to such cases, CMS makes no payment for In this situation, we proposed that we admission, as required under the SNF 3- the services and the SNF may not charge would apply the following rules: day rule waiver the beneficiary for the services and must • We would make no payment to the (§ 425.612(a)(1)(iii)(B)(4)) and the terms return any monies collected from the SNF affiliate for such services. of the SNF’s affiliate agreement with the beneficiary. Additionally, under the • The SNF affiliate must not charge ACO. In this scenario, Medicare would Next Generation ACO Model, the ACO the beneficiary for the expenses deny payment of the SNF claim under must indemnify and hold the incurred for such services, and the SNF existing FFS rules because the beneficiary harmless for payment for the affiliate must return to the beneficiary beneficiary did not have a qualifying services. We believe it is appropriate to any monies collected for such services.

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• The ACO may be required to submit therefore specifically solicited comment protections in place under the Next a corrective action plan to CMS for on whether it is reasonable to hold SNFs Generation ACO Model. approval as specified at § 425.216(b) that are SNF affiliates responsible for all Comment: A commenter addressing what actions the ACO will claims that are rejected solely as a result recommended that the first grace period take to ensure that the SNF 3-day rule of lack of a qualifying inpatient hospital of the calendar year be extended to waiver is not misused in the future. If stay. We also solicited comment on accommodate a very large exclusion file after being given an opportunity to act whether the ACO rather than or in that is distributed in July. This upon the corrective action plan the ACO addition to the SNF affiliate, should be commenter further noted that the July fails to come into compliance, approval held liable for such claims and under exclusion file often includes a change in to use the waiver will be terminated in what circumstances. We also solicited file format or other criteria for files accordance with § 425.612(d). We noted comment on our proposal to modify the transmitted to ACOs, such that it that in accordance with our existing waiver under § 425.612(a)(1) to include requires significant time to work program rules at §§ 425.216 and a 90-day grace period for beneficiaries through the data file transmission and 425.218, CMS retains the authority to prospectively assigned to a waiver- loading process. take corrective action, including approved ACO at the start of the Response: We are a somewhat unclear terminating an ACO for non-compliance performance year but later excluded. We about the concerns regarding the with program rules. A misuse of a solicited comment on the proposed exclusion file referenced in this waiver under § 425.612 would length of the grace period, and in comment and believe they may perhaps constitute non-compliance with particular whether the grace period relate to an EHR measure exclusion file program rules. Accordingly, we should be less than 90 days, given our that is unrelated to the quarterly proposed to codify at new provision at expectation that ACOs will share the beneficiary exclusion process. § 425.612(d)(4) providing that misuse of quarterly beneficiary exclusion lists Regardless, we believe a 90-day grace a waiver under § 425.612 may result in with their SNF affiliates, ACO period is more than sufficient time for CMS taking remedial action against the participants, and ACO providers/ the appropriate communications to ACO under §§ 425.216 and 425.218, up suppliers in a timely manner. Finally, occur regarding exclusions from the to and including termination of the ACO we solicited comment on any other prospective assignment list. Under the from the Shared Savings Program. related issues that we should consider rules governing the SNF 3-day rule We proposed that if the SNF in connection with these proposals to waiver, the ACO must have a submitting the claim is a SNF affiliate protect beneficiaries from significant communication plan, a beneficiary of a waiver-approved ACO, and the only financial liability for non-covered SNF evaluation and admission plan, and a reason for the rejection of the claim is services related to the waiver of the SNF care management plan in place prior to lack of a qualifying inpatient hospital 3-day rule under the Shared Savings our approval of the ACO for use of the stay, then CMS would assume the SNF Program. waiver. The requirement that an ACO intended to rely upon the SNF 3-day The following is a summary of the have these plans in place should help to rule waiver. We would not assume the comments we received on these mitigate concerns regarding the length SNF intended to rely upon the SNF 3- proposals. of the grace period by ensuring that the day rule waiver if the SNF is not a SNF Comment: Commenters, in general, ACO has established procedures in affiliate of a waiver-approved ACO supported the proposed enhanced place to govern communications because the waiver is not available to beneficiary protections under the SNF between the ACO, its SNF affiliates, SNFs more broadly. We explained that 3-day rule waiver that are largely ACO participants, and ACO providers/ we believe intended reliance on the consistent with the beneficiary suppliers regarding beneficiary waiver is an important factor in protections in place under the Next eligibility and admissions under the determining whether the proposed Generation ACO Model. Commenters terms of the waiver. Thus, we continue additional beneficiary protections agreed that it would be appropriate to to believe that a 90-day grace period is should apply. Outside the context of an hold beneficiaries harmless for non- a sufficient time period for an ACO to intent to rely on the SNF 3-day rule covered SNF services if a SNF affiliate process the quarterly exclusion list and waiver, we do not believe it would be admitted a beneficiary who was not transmit any beneficiary exclusions to necessary to include additional qualified for the waiver without a its ACO participants, ACO providers/ beneficiary protections under the qualifying inpatient stay. Commenters suppliers, and SNF affiliates. Shared Savings Program because there also generally agreed that a 90-day grace Comment: Some commenters is no reason for either the beneficiary or period from the date that CMS delivers supported our proposal that no the SNF to expect that different the quarterly beneficiary exclusion list payments would be made to SNF coverage rules would apply to SNF to ACOs is a reasonable period to allow affiliates for SNF services furnished services. In these other situations, the ACOs to incorporate beneficiary without a qualifying inpatient hospital beneficiary protections generally exclusions into their processes, stay to beneficiaries who are not applicable under traditional FFS including communicating the updated assigned to the ACO or who are not in Medicare, noted earlier in this section, beneficiary information to ACO the 90-day grace period. These continue to apply. participants, ACO providers/suppliers, commenters agreed that the financial We solicited comments on these and SNF affiliates. Although most responsibility for SNF stays that do not proposals. We noted that under our commenters supported the proposals meet the waiver criteria should lie with proposed beneficiary protection without additional elaboration, a few the SNF because, in accordance with provision, a SNF affiliate would be commenters expressed other specific our rules for use of the waiver by SNF prohibited from charging a beneficiary concerns or made additional suggestions affiliates, SNF affiliates are responsible for non-covered SNF services even in which are addressed in this section. for confirming a beneficiary’s eligibility cases where the beneficiary explicitly Response: We appreciate commenters’ to receive services under the waiver requested or agreed to being admitted to support for our proposal to incorporate prior to admission. Some commenters the SNF in the absence of a qualifying enhanced beneficiary protections under disagreed with this aspect of the 3-day hospital stay if all other the SNF 3-day rule waiver that are proposal, suggesting that ACOs should requirements for coverage are met. We largely consistent with the beneficiary be responsible for at least some the

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liability. One commenter indicated that, and all of its SNF affiliates as required plan in cases where the SNF affiliate, SNF affiliates should not be accountable at § 425.612(a)(1)(i)(A)(1). In accordance not the ACO, is responsible for for identifying waiver-eligible with our SNF waiver guidance on the inappropriate use of the waiver, as such beneficiaries and suggested that CMS CMS Web site at https://www.cms.gov/ corrective action plans could be ‘‘require hospitals to share the list of Medicare/Medicare-Fee-for-Service- resource intensive for ACOs. waiver-eligible Track 3-enrolled Payment/sharedsavingsprogram/ Response: We continue to believe that beneficiaries with all of their ACOs and Downloads/SNF-Waiver-Guidance.pdf, in some circumstances it could be partner SNFs.’’ This commenter also the communication plan should include appropriate for an ACO to be required requested that CMS explore additional detailed communication processes to submit a corrective action plan, policies that would give SNF affiliates including for example, identifying and including in some cases where a SNF independent access to beneficiary designating person(s) at the ACO with affiliate may be responsible for waiver eligibility information that they whom SNF affiliates will communicate inappropriate use of the SNF 3-day rule could access prior to admission to verify and coordinate admissions, and waiver. The possibility of compliance if a beneficiary meets the eligibility explaining how the ACO will respond to action provides an incentive for ACOs requirements for the waiver. To questions and complaints related to the to work together with their SNF illustrate possibilities, the commenter ACO’s use of the SNF 3-day waiver from affiliates to ensure that the SNF 3-day suggested that CMS could: (1) Make it SNF affiliates, ACO participants, ACO rule waiver is used appropriately, and a requirement for SNF affiliate providers/suppliers, beneficiaries, acute reflects the requirement that ACOs must agreements that the ACO provide all care hospitals, and other stakeholders. enter into agreements with their SNF SNF affiliates with timely, accurate lists ACOs are also required to establish a affiliates that contain detailed of waiver-eligible beneficiaries; or (2) beneficiary evaluation and admission requirements providing for the proper CMS could integrate information plan for beneficiaries admitted to a SNF use of the waiver. We are finalizing the regarding eligibility for the SNF 3-day affiliate under the SNF 3-day rule proposal that in cases where a SNF rule waiver into the Common Working waiver that is approved by the ACO affiliate of a Track 3 ACO has misused File so that SNFs may independently medical director and the healthcare the SNF 3-day rule waiver, the ACO verify a beneficiary’s eligibility under professional responsible for the ACO’s may be required to submit a corrective the waiver. quality improvement and assurance action plan to CMS for approval as Response: After reviewing the processes under § 425.112. Further, as specified at § 425.216(b) addressing comments, we continue to believe the part of their waiver application, ACOs what actions the ACO will take to proposed policy, which is based on are required to describe how they plan ensure that the SNF 3-day rule waiver beneficiary protections under the Next to evaluate and periodically update is not misused in the future. We are also Generation ACO Model, is also their plan (see section 6 of the guidance finalizing the proposal to codify a new appropriate under the Shared Savings at https://www.cms.gov/Medicare/ provision at § 425.612(d)(4) providing Program. Under § 425.612(a)(1)(iii)(B), Medicare-Fee-for-Service-Payment/ that misuse of a waiver under § 425.612 in order to be a SNF affiliate, a SNF sharedsavingsprogram/Downloads/SNF- may result in CMS taking remedial must agree to validate the eligibility of Waiver-Guidance.pdf). It is also action against the ACO under a beneficiary to receive covered SNF recommended in the guidance that the §§ 425.216 and 425.218, up to and services in accordance with the waiver beneficiary evaluation and admission including termination of the ACO from prior to admission to the SNF, and plan include detailed requirements the Shared Savings Program. otherwise comply with the requirements including, for example, a protocol for an Comment: One commenter suggested and conditions of the Shared Savings ACO provider/supplier who is a that CMS should also modify the Program. As a result, we do not believe physician to evaluate and approve existing financial protections in the it is unreasonable to hold the SNF admissions to a SNF affiliate pursuant Medicare Claims Processing Manual affiliate financially responsible if it to the waiver and consistent with the Chapter 30—Financial Protections at admits a beneficiary that is neither beneficiary eligibility requirements section 70.2.2.2 to address the SNF 3- prospectively assigned to a Track 3 ACO described at § 425.612(a)(1)(ii) and a day rule waiver rules. nor in a 90-day grace period without a protocol for educating and training SNF Response: We will further consider qualifying inpatient hospital stay. We affiliates regarding waiver requirements whether revisions are necessary to the also believe it is reasonable to hold the and the ACO’s communications plan, Medicare Claims Processing Manual SNF affiliate fully responsible under beneficiary evaluation and admission and/or other guidance documents these circumstances because a SNF plan, and care management plan for related to SNF discharges and billing. affiliate is obligated under the terms and purposes of the SNF 3-Day Waiver. Final Action: We are finalizing the conditions of the SNF 3-day rule waiver We believe these requirements SNF 3-day rule waiver beneficiary to validate the beneficiary’s eligibility adequately address the commenter’s protections described in this section as for use of the waiver prior to admission. concerns about SNF affiliates’ ability to proposed. Specifically, we are Further, we do not believe that it is verify beneficiaries’ eligibility to receive modifying the SNF 3-day rule waiver necessary to include the suggested covered SNF services under the SNF 3- under § 425.612(a)(1) to include a 90- additional requirements for SNF affiliate day rule waiver. However, as we day grace period that will permit agreements. The current requirements develop operational procedures and payment for SNF services provided to provide SNFs with the flexibility to guidance documents, we will further beneficiaries without a qualifying address, in their SNF affiliate consider whether it would be feasible to inpatient stay who were initially on the agreements with Track 3 ACOs, any develop a mechanism that could permit ACO’s prospective assignment list for a concerns they may have about the SNF affiliates to verify, though a source performance year but were subsequently processes used by ACOs to other than the ACO, a beneficiary’s excluded during the performance year, communicate which beneficiaries are eligibility to receive SNF services under if such services would otherwise be eligible to receive covered SNF services the waiver. covered under the SNF 3-day rule under the waiver. Comment: A few commenters waiver. In addition, in the event that a ACOs must create and implement a suggested that ACOs should not be SNF that is a SNF affiliate of a Track 3 communication plan between the ACO required to submit a corrective action ACO that has been approved for the

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SNF 3-day rule waiver admits a FFS the regulations at § 425.110(b) indicate menu of options. Specifically, we beneficiary who was never that if at any time during the proposed to update the regulations at prospectively assigned to the ACO (or performance year, an ACO’s assigned § 425.110(b)(1) to indicate that in the was assigned but later excluded and the population falls below 5,000, the ACO event an ACO falls below 5,000 assigned 90-day grace period has lapsed), and the may be subject to the actions described beneficiaries at the time of financial claim is rejected only for lack of a in §§ 425.216 and 425.218; the reconciliation, the ACO participating qualifying inpatient hospital stay, we regulations further indicate at under a two-sided risk track will be will make no payment to the SNF, and § 425.110(b)(1) that while under a CAP, eligible to share in savings (or losses) the SNF may not charge the beneficiary the ACO remains eligible for shared and the MSR/MLR will be set at a level for the non-covered SNF services. In savings and losses and the MSR and consistent with the choice of MSR/MLR this circumstance, the SNF affiliate will MLR (if applicable) is set at a level that the ACO made at the start of the be prohibited from charging a consistent with the number of assigned agreement period. If the Track 2 or beneficiary for non-covered SNF beneficiaries. We have applied this rule Track 3 ACO selected a symmetrical services even in cases where the in the past to perform financial MSR/MLR option based on a fixed beneficiary explicitly requested or reconciliation for ACOs that fell below percentage (for example, zero percent or agreed to being admitted to the SNF in 5,000 assigned beneficiaries. In these a percentage between 0.5 and 2 percent) the absence of a qualifying 3-day cases, the ACO was subject to a CAP regardless of ACO size, then the current hospital stay, if all other requirements and financial reconciliation was based methodology for use of a variable MSR/ for coverage are met. We are also adding on a variable MSR/MLR that was MLR based on the ACO’s number of a provision at § 425.612(d)(4) providing determined by the number of assigned assigned beneficiaries would not apply. that misuse of a waiver under § 425.612 beneficiaries. For example, we have For example, if at the beginning of the may result in CMS taking remedial calculated the ACO’s MSR based on an agreement period the ACO chose a 1.0 action against the ACO under expanded sliding scale that includes a percent MSR/MLR and the ACO’s §§ 425.216 and 425.218, up to and range of 3,000 to 4,999 assigned assigned population falls below 5,000, including termination of the ACO from beneficiaries with a corresponding MSR the MSR/MLR will remain 1.0 percent the Shared Savings Program. range of 5.0 to 3.9 percent. for purposes of financial reconciliation We strongly believe it is important to However, ACOs under risk-based while the ACO is under a CAP. Further, ensure that beneficiaries have tracks are not limited to financial as we noted in earlier rulemaking, if the appropriate financial protections, reconciliation under a variable MSR/ ACO has elected a variable MSR/MLR, including financial protection against MLR that is based on the number of the methodology for calculating the misuse of the waiver prior to approving assigned beneficiaries. In the June 2015 variable MSR/MLR under a two-sided any SNF 3-day rule waiver applications final rule (see 80 FR 32769–32771, and model is consistent with the from Track 3 ACOs. We also recognize 32779–32780), we finalized a policy that methodology for calculating the variable that ACOs and their SNF affiliates could provides ACOs under two-sided MSR that is required under the under be reluctant to enter into a SNF affiliate performance-based risk tracks with an the one-sided model (Track 1) (see 80 agreement without there being clarity as opportunity to choose among several FR 32769 through 32771; 32779 through to their potential responsibility for non- options for establishing their MSR/MLR. 32780). Under the one-sided shared covered SNF services related to the In addition to being able to choose a savings model (Track 1), we have waiver. For these reasons, we are also symmetrical MSR/MLR that varies accounted for circumstances where an developing a process for Track 3 ACOs based on the ACO’s number of assigned ACO’s number of assigned beneficiaries that have already applied for the SNF 3- beneficiaries, ACOs under two-sided falls below 5,000, by expanding the day rule waiver for the 2017 performance-based risk tracks can also variable MSR range based on input from performance year to confirm that they choose from a menu of non-variable the CMS Office of the Actuary (OACT). MSR/MLR options (either a 0 percent and their SNF affiliates agree to comply Thus, in the case where a Track 2 or MSR/MLR or a symmetrical MSR/MLR with all requirements related to the SNF Track 3 ACO selects a variable MSR/ in a 0.5 percent increment between 0.5 3-day rule waiver, including the new MLR based on its number of assigned through 2.0 percent). beneficiaries, and the ACO’s number of requirements we are adopting in this We stated in the CY 2017 PFS rulemaking. ACOs and SNF affiliates assigned beneficiaries falls below 5,000, proposed rule that we believe it is we proposed to continue to use an that do not agree to comply with all important to clarify the policy regarding requirements will be ineligible to offer approach for determining the MSR/MLR situations where an ACO under a two- range consistent with the approach for services under the SNF 3-day rule sided performance-based risk track has calculating the MSR range under the waiver. We note that this confirmation chosen a non-variable MSR/MLR at the one-sided model. process may delay approval of ACOs’ start of the agreement period but has The following is a summary of the applications for the SNF 3-day rule fallen below 5,000 assigned comments we received on these waiver for the 2017 performance year; beneficiaries at the time of financial proposals. however, we do not anticipate approval reconciliation. As discussed in detail in Comment: Commenters supported will be delayed beyond the first quarter the June 2015 final rule, we continue to this proposal. One commenter of 2017. believe that ACOs under two-sided suggested, without providing a 4. Technical Changes performance-based risk tracks are best justification, that in the event an ACO’s positioned to determine the level of risk assigned beneficiary population falls a. Financial Reconciliation for ACOs that they are prepared to accept. below 5,000, the MSR be capped at 3.9 That Fall Below 5,000 Assigned Therefore, we proposed to update the percent in cases where the MSR/MLR Beneficiaries regulations at § 425.110(b)(1) to be varies based on the number of Section 1899(b)(2)(D) of the Act consistent with the regulatory changes beneficiaries. The commenter did not includes a requirement that a in the June 2015 final rule that permit expressly make a similar participating ACO must have a ACOs under a two-sided performance- recommendation for capping the MLR. minimum of 5,000 Medicare FFS based risk track (Track 2 and Track 3) Response: We appreciate the support beneficiaries assigned to it. Currently, to choose their own MSR/MLR from a for this proposal. For ACOs with a

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variable MSR and MLR (if applicable), establishing a more accurate financial L. Value-Based Payment Modifier and the MSR and MLR (if applicable) will be benchmark, and determining the Physician Feedback Program set at a level consistent with the number prospective or preliminary prospective 1. Overview of assigned beneficiaries. For ACOs with assignment list for the upcoming a fixed MSR/MLR, the MSR/MLR will performance year. In response to these Section 1848(p) of the Act requires remain fixed at the level consistent with inquiries, we initially developed that we establish a value-based payment the ACO’s choice of MSR and MLR that subregulatory guidance that allowed modifier (VM) and apply it to specific physicians and groups of physicians the the ACO made at the start of the claims billed under the TIN of a merged Secretary determines appropriate agreement period. In addition, we or acquired entity to be considered in disagree that it would be appropriate to starting January 1, 2015, and to all certain circumstances. In that guidance cap the MSR (but not the MLR) at 3.9 physicians and groups of physicians by we indicated that the merged or percent in cases where the MSR/MLR January 1, 2017. On or after January 1, varies based on the number of acquired entity’s TIN may no longer be 2017, section 1848(p)(7) of the Act beneficiaries in the event the ACO falls used to bill Medicare. In the June 2015 provides the Secretary discretion to below 5,000 assigned beneficiaries final rule, we codified the policies apply the VM to eligible professionals beneficiaries. outlined in this guidance allowing for (EPs) as defined in section 1848(k)(3)(B) Section 1899(d)(1)(B)(i) of the Act consideration of claims billed under of the Act. Section 1848(p)(4)(C) of the specifies that the Secretary shall merged or acquired entities’ TINs for Act requires the VM to be budget determine the appropriate percent by purposes of beneficiary assignment and neutral. The VM and Physician which an ACO’s expenditures must be establishing the ACO’s benchmark, Feedback program continue CMS’ lower than its benchmark in order for provided certain requirements were met initiative to recognize and reward the ACO to be eligible to share in (§§ 425.204(g), 425.118(a)(2)). However, clinicians based on the quality and cost savings to account for normal variation the regulation at § 425.204(g) indicates of care provided to their patients, in expenditures under Title XVIII. that an ACO may request that CMS increase the transparency of health care Consistent with the statute, this consider, for purposes of beneficiary quality information and to assist percentage must be based upon the assignment and establishing the ACO’s clinicians and beneficiaries in number of Medicare fee-for-service benchmark under § 425.602, claims improving medical decision-making and health care delivery. As stated in the CY beneficiaries assigned to the ACO. As billed by ‘‘Medicare-enrolled’’ entities’ 2016 PFS final rule with comment explained in the November 2011 final TINs that have been acquired through rule, we believe that the most period (80 FR 71277), the MACRA was sale or merger by an ACO participant. appropriate policy concerning enacted on April 16, 2015. Under Because the regulation at § 425.204(g) determination of the ‘‘appropriate section 1848(p)(4)(B)(iii) of the Act, as percent’’ for the MSR would achieve a refers to such merged or acquired TINs amended by section 101(b)(3) of balance between the advantages of as ‘‘Medicare-enrolled,’’ we have MACRA, the VM shall not be applied to making incentives and rewards received inquiries from ACOs regarding payments for items and services available to successful ACOs and whether such merged or acquired TINs furnished on or after January 1, 2019. prudent stewardship of the Medicare must continue to be Medicare-enrolled Section 1848(q) of the Act, as added by Trust Funds (76 FR 67927). Capping the after the merger or acquisition has been section 101(c) of MACRA, establishes MSR for Track 1 ACOs would not be completed and the TINs are no longer the Merit-based Incentive Payment consistent with the statute and our used to bill Medicare. System (MIPS) that shall apply to established policy for computing the We stated in the CY 2017 PFS payments for items and services MSR for Track 1 ACOs. Capping only proposed rule that it was not our intent furnished on or after January 1, 2019. the MSR but not the MLR for Track 2 to establish such a requirement. We 2. Overview of Existing Policies for the or 3 ACOs would create an asymmetry stated we do not believe there would be VM that would make it easier for the ACO a program purpose to require the TIN of to share in savings but not in losses. To In the CY 2013 PFS final rule with a merged or acquired entity to maintain the extent that the commenter was comment period, we discussed the goals recommending capping both the MSR Medicare enrollment if it is no longer of the VM and also established that and MLR for ACOs in Tracks 2 and 3 used to bill Medicare. Therefore, to specific principles should govern the that choose a variable MSR/MLR, we address this issue, we proposed a implementation of the VM (77 FR believe this could be an approach technical change to § 425.204(g) to 69307). We refer readers to that rule for worthy of consideration in future clarify that the merged/acquired TIN is a detailed discussion. In the CY 2013 rulemaking because the approach would not required to remain Medicare PFS final rule with comment period (77 equalize the risk for the ACO and CMS. enrolled after it has been merged or FR 69310), we finalized policies to Final Action: We are finalizing this acquired and is no longer used to bill phase-in the VM by applying it policy and the revisions to Medicare. beginning January 1, 2015, to Medicare PFS payments to physicians in groups § 425.110(b)(1) as proposed, but are The following is a summary of the of 100 or more EPs. A summary of the making a minor editorial revision to comments we received on these existing policies that we finalized for paragraph (b)(1)(ii) in order to eliminate proposals. a redundant reference. the CY 2015 VM can be found in the CY Comment: The few comments 2014 PFS proposed rule (78 FR 43486 b. Requirements for Merged or Acquired received on this issue supported the through 43488). Subsequently, in the CY TINs proposal. 2014 PFS final rule with comment ACOs frequently request that we take Response: We appreciate the support period (78 FR 74765 through 74787), we into account the claims billed by the for this proposal. finalized policies to continue the phase- TINs of practices that have been in of the VM by applying it starting acquired by sale or merger for the Final Action: We are finalizing the January 1, 2016, to payments under the purpose of meeting the minimum technical change to § 425.204(g) as Medicare PFS for physicians in groups assigned beneficiary threshold, proposed. of 10 or more EPs. Then, in the CY 2015

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PFS final rule with comment period (79 mechanism is appropriate for groups of based on the aggregate amount of FR 67931 through 67966), we finalized physicians to review and to identify any downward payment adjustments. policies to complete the phase-in of the possible errors prior to application of Furthermore, this approach can create VM by applying it starting January 1, the VM, and we established an informal uncertainty for groups and solo 2017, to payments under the Medicare inquiry process at § 414.1285. practitioners about their final VM PFS for physicians in groups of 2 or In the CY 2016 PFS final rule with payment adjustment making it difficult more EPs and to physician solo comment period (80 FR 71294 through for them to plan and make forecasts. practitioners. In the CY 2016 PFS final 71295), for the CY 2017 and CY 2018 Due to the volume and complexities rule with comment period (80 FR 71277 payment adjustment periods, we of the informal review issues, the through 71279), we finalized that in the finalized a deadline of 60 days that inconsistency of available PQRS data to CY 2018 payment adjustment period, would start after the release of the calculate a TIN’s quality composite, the the VM will apply to nonphysician EPs QRURs for the applicable performance case-by-case nature of the informal who are physician assistants (PAs), period for a group or solo practitioner to review process, and the condensed nurse practitioners (NPs), clinical nurse request a correction of a perceived error timeline to calculate an accurate VM specialists (CNSs), and certified related to the VM calculation. We also upward payment adjustment factor, we registered nurse anesthetists (CRNAs) in finalized the continuation of the process expressed our belief that we needed to groups with 2 or more EPs and to PAs, for accepting requests from groups and update the VM informal review policies NPs, CNSs, and CRNAs who are solo solo practitioners to correct certain and establish in rulemaking how the practitioners. errors made by CMS or a third-party quality and cost composites under the 3. Provisions of This Final Rule vendor (for example, PQRS-qualified VM would be affected if unanticipated registry). We stated we would continue issues were to arise (for example, the As a general summary, we proposed the approach of the initial corrections program issues described in the CY to update the VM informal review process to classify a TIN as ‘‘average 2017 PFS proposed rule), errors made policies and establish how the quality quality’’ in the event we determine a by a third-party such as a vendor, or and cost composites under the VM third-party vendor error or CMS made errors in our calculation of the quality would be affected for the CY 2017 and an error in the calculation of the quality and/or cost composites). We noted that CY 2018 payment adjustment periods in composite and the infrastructure was the intent of these proposals is not to the event that unanticipated program not available to allow for recomputation provide relief for EPs and groups who issues arise. of the quality measure data. fail to report under PQRS, but rather to a. Expansion of the Informal Inquiry Additionally, we finalized that we provide a mechanism for addressing Process To Allow Corrections for the would reclassify a TIN as Category 1 unexpected issues such as the data VM when PQRS determines on informal integrity issues discussed in the review that at least 50 percent of the proposed rule. Section 1848(p)(10) of the Act TIN’s EPs meet the criteria to avoid the We further noted that limiting the provides that there shall be no PQRS downward payment adjustment potential movement of TINs between administrative or judicial review under for the relevant payment adjustment VM quality tiers based on informal section 1869 of the Act, section 1878 of year. If the group was initially classified review may result in a more accurate the Act, or otherwise of the following: as Category 2, then we would not expect • The establishment of the VM. adjustment factor calculation and • The evaluation of the quality of care to have data for calculating their quality provide greater predictability for the composite, including the establishment composite, in which case they would be CMS’ Office of the Actuary (OACT) in of appropriate measures of the quality of classified as ‘‘average quality’’; however, making assumptions around the care. if the data is available in a timely adjustment factor including • The evaluation of the cost manner, then we would recalculate the assumptions around the impact of composite, including the establishment quality composite. outstanding informal reviews at the time of appropriate measures of costs. As we noted in the CY 2017 PFS of the calculations. We expressed our • The dates of implementation of the proposed rule (81 FR 46443 through belief that our proposals would help VM. 46444), as a result of issues that we groups and solo practitioners to better • The specification of the initial became aware of prior to and during the predict the outcome of their final VM performance period and any other CY 2016 VM informal review process, adjustment and reduce uncertainty as performance period. we learned that re-running QRURs and we continue to improve our systems. • The application of the VM. recalculating the quality composite is We requested comment on all four of • The determination of costs. not always practical or possible, given the scenarios we proposed. We provide These statutory requirements the diversity and magnitude of the a combined summary of comments regarding limitations of review are errors, timing of when we become aware received on the four scenarios later in reflected in § 414.1280. We previously of an error, and practical considerations this section of this final rule, following indicated in the CY 2013 PFS final rule in needing to compute a final VM the individual descriptions of the with comment period (77 FR 69326) that upward payment adjustment factor after scenarios proposed. we believed an informal review the performance period has ended, Table 44 summarizes our proposals.

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TABLE 44—QUALITY AND COST COMPOSITE STATUS FOR TINS DUE TO INFORMAL REVIEW DECISIONS AND WIDESPREAD QUALITY AND COST DATA ISSUES

Scenario 1: TINS moving from Scenario 2: Non-GPRO Category Scenario 3: Category 1 TINs with Scenario 4: Category 1 TINs with Category 2 to Category 1 as a re- 1 TINs with additional EPs avoid- widespread quality data issues widespread claims data issues sult of PQRS or VM informal re- ing PQRS payment adjustment as view process a result of PQRS informal review process Initial Revised Recalculated Revised Initial Revised Initial Revised composite composite composite composite composite composite composite composite

Quality ...... N/A ...... Average ...... Low ...... Average ...... N/A ...... Average ...... Low ...... Average. N/A ...... Average ...... Average ...... Average ...... N/A ...... Average ...... Average ...... Average. N/A ...... Average ...... High ...... High ...... N/A ...... Average ...... High ...... High. Cost ...... Low ...... Low ...... Low ...... Low ...... Low ...... Low ...... Low ...... Low. Average ...... Average ...... Average ...... Average ...... Average ...... Average ...... Average ...... Average. High ...... Average ...... High ...... High ...... High ...... Average ...... High ...... Average.

Scenario 1: TINs Moving From Category payment adjustment periods that when Our proposal to calculate the cost 2 to Category 1 as a Result of PQRS or determining whether a group would be composite and assign ‘‘average cost’’ if VM Informal Review Process included in Category 1, we would the cost composite was initially consider whether the 50 percent classified as ‘‘high cost’’ would alleviate As finalized in the CY 2016 PFS final threshold had been met, regardless of concerns from stakeholders that a TIN rule with comment period, for the CY whether the group registered to may receive a downward VM payment 2017 VM, Category 1 will include those participate in the PQRS GPRO for the adjustment under the quality-tiering groups that meet the criteria to avoid the relevant performance period. We methodology as a result of being CY 2017 PQRS payment adjustment as expressed our belief that this policy classified as average quality and high a group practice participating in the would allow groups that register for a cost. Under our proposal discussed PQRS Group Practice Reporting Option above, for TINs in Scenario 1, we would (GPRO) in CY 2015 and groups that PQRS GPRO, but fail as a group to meet the criteria to avoid the PQRS payment not consider a TIN’s actual performance have at least 50 percent of the group’s on the quality measures or calculate a EPs meet the criteria to avoid the CY adjustment an additional opportunity for the quality data reported by quality composite score; rather, we 2017 PQRS payment adjustment as would classify the TIN’s quality individuals (80 FR 71280). Category 1 individual EPs in the group to be taken into account for the purposes of composite as average quality for the also includes those solo practitioners reasons stated above. In this scenario, that meet the criteria to avoid the CY applying the VM. We noted that consequently, because of this policy we we do not believe that we should retain 2017 PQRS payment adjustment as a TIN’s ‘‘high cost’’ designation when individuals. Category 2 will include anticipate that the number of TINs who could fall into Scenario 1 would be the TIN’s actual cost performance is not groups and solo practitioners that are being compared to the TIN’s actual subject to the CY 2017 VM and do not minimal; however, we believe it is necessary to have a policy in place, in quality performance, as it is possible the fall within Category 1 (79 FR 67939). We TIN might have scored high quality if finalized a similar two-category the event that CMS determines on informal review that Category 2 TINs actual performance had been approach for the CY 2018 VM based on considered. We believe that these participation in the PQRS by groups and had been negatively impacted by a third-party vendor error or CMS made proposals would help groups and solo solo practitioners in 2016 (80 FR 71280 practitioners who receive a favorable through 71281). an error in the calculation of the quality composite. We proposed to apply these determination on informal review to In the CY 2017 PFS proposed rule, we better predict the outcome of their final proposed that, if a TIN were initially policies for the CY 2017 VM and CY 2018 VM. VM adjustment and reduce uncertainty classified as Category 2, and about the impact of the informal review. subsequently, through the PQRS or VM Calculating a quality composite for a Additionally, it is important to note that informal review process, it was TIN that was initially classified as groups or solo practitioners who submit reclassified as Category 1, then we Category 2, then reclassified as Category an informal review request would not would classify the TIN’s quality 1 during the informal review process automatically be covered by the policy composite as ‘‘average quality,’’ instead would be operationally complex, given proposed for Scenario 1. In the CY 2017 of attempting to calculate the quality a number of factors: The timeline for PFS proposed rule, we stated that we composite (81 FR 46444). We also determining and applying the VM would verify on informal review that proposed to calculate the TIN’s cost adjustments for all TINs subject to the the group or solo practitioner did composite using the quality-tiering VM; the volume of informal reviews; the submit complete and accurate data and methodology. If the TIN were classified need to calculate the VM upward did meet the criteria to avoid the PQRS as ‘‘high cost’’ based on its performance payment adjustment factor as close to payment adjustment to be included in on the cost measures, then we proposed the beginning of the payment Category 1. to reclassify the TIN’s cost composite as adjustment period as possible; and ‘‘average cost.’’ If the TIN were uncertainty about the availability of the Scenario 2: Non-GPRO Category 1 TINs classified as ‘‘average cost’’ or ‘‘low PQRS quality data. Therefore, With Additional EPs Avoiding PQRS cost’’, then we proposed that the TIN classifying the quality composite as Payment Adjustment as a Result of would retain the calculated cost tier ‘‘average quality’’ would offer a PQRS Informal Review Process designation. We noted that in the CY predictable decision for all informal As finalized in the CY 2016 PFS final 2016 PFS final rule with comment reviews where a TIN changes rule with comment period, for the CY period (80 FR 71280), we finalized a classification from Category 2 to 2017 VM, Category 1 will include policy for the CY 2017 and 2018 Category 1. groups that have at least 50 percent of

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the group’s EPs meet the criteria to that we would verify on informal review composite as average cost for purposes avoid the CY 2017 PQRS payment that an EP did submit complete and of determining their VM adjustment. adjustment as individuals (80 FR accurate data and did meet the criteria In the CY 2017 PFS proposed rule, we 71280). A similar policy was finalized to avoid the PQRS payment adjustment noted that we expect quality data issues for the CY 2018 VM (80 FR 71280). In as an individual in order for the TIN to to be significantly limited moving the CY 2017 PFS proposed rule (81 FR be included in Category 1. forward, due to newly-added front-end 46455), we proposed that, if a TIN were edits. Additionally, we noted that TINs Scenario 3: Category 1 TINs With classified as Category 1 for the CY 2017 are ultimately responsible for the data Widespread Quality Data Issues VM by having at least 50 percent of the that are submitted by their third-party group’s EPs meet the criteria to avoid In cases where there is a systematic vendors and that we expect that TINs the CY 2017 PQRS payment adjustment issue with any of a Category 1 TIN’s are holding their vendors accountable as individuals, and subsequently, quality data that renders it unusable for for accurate reporting. We noted that, through the PQRS informal review calculating a TIN’s quality composite, while we understand that data process, it is determined that additional we proposed to classify the TIN’s submission requirements are evolving EPs that are in the TIN also meet the quality composite as average quality. and that both vendors and CMS are criteria to avoid the CY 2017 PQRS For this proposal, we consider developing capabilities for reporting payment adjustment as individuals, widespread quality data issues, as issues and assessing performance, we are then the following policies would be that impact multiple TINs and we are considering further policies to promote used to determine the TIN’s quality and unable to determine the accuracy of the complete and accurate reporting by cost composites: data submitted via these TINs (for registries and other third-party entities • If the TIN’s quality composite is example, the EHR and QCDR issues for that submit data on behalf of groups and initially classified as ‘‘low quality’’, the CY 2014 performance period as EPs. then we proposed to reclassify the TIN’s described in the CY 2017 PFS proposed Scenario 4: Category 1 TINs With quality composite as ‘‘average quality.’’ rule (81 FR 46455). This proposal would Widespread Claims Data Issues If the TIN’s quality composite is initially offer a predictable designation for all classified as ‘‘average quality’’ or ‘‘high TINs under this scenario. If we determine after the release of the quality’’, then we proposed that the TIN We also proposed to calculate the Quality and Resource Use Reports would retain that quality tier TIN’s cost composite using the quality- (QRURs) that there is a widespread designation. tiering methodology. If the TIN were claims data issue that impacts the • We would maintain the cost classified as ‘‘high cost’’ based on its calculation of the quality and/or cost composite that was initially calculated. performance on the cost measures, then composites for Category 1 TINs, we We proposed to apply these policies we proposed to reclassify the TIN’s cost propose to recalculate the quality and for the CY 2017 VM and CY 2018 VM. composite as ‘‘average cost.’’ If the TIN cost composites for affected TINs. For Under these policies, we would not were classified as ‘‘average cost’’ or this proposal, we consider widespread recalculate the TIN’s quality composite ‘‘low cost’’, then we proposed that the claims data issues, as issues that impact to include the additional EPs that were TIN would retain the calculated cost tier multiple TINs and require the determined to have met the criteria to designation. We proposed to apply these recalculation of the quality and/or cost avoid the PQRS payment adjustment as policies for the CY 2017 VM and CY composites (for example, the incomplete individuals through the PQRS informal 2018 VM. claims identification and specialty review process. As discussed under As discussed under Scenario 1, our adjustment issues described in the CY Scenario 1, recalculating the quality proposal to calculate the cost composite 2017 PFS proposed rule (81 FR 46446) composite is operationally complex, and and assign ‘‘average cost’’ if the cost After recalculating the composites, if we may not have PQRS data for the composite is initially classified as ‘‘high the TIN’s quality composite is classified additional EPs, because they were cost’’ would alleviate concerns from as low quality, then we proposed to initially determined not to have met the stakeholders that a TIN may receive a reclassify the quality composite as criteria to avoid the PQRS payment downward VM payment adjustment average quality, and if the TIN’s cost adjustment. In addition, we seek to under the quality-tiering methodology composite is classified as high cost, we avoid a situation where by recalculating as a result of being classified as average proposed to reclassify the cost the quality composite, a TIN may be quality and high cost. Similarly, for composite as average cost. If the TIN is subject to a lower quality tier TINs in Scenario 3, we would not classified as average quality, high designation because a few EPs in the consider a TIN’s actual performance on quality, average cost or low cost, then TIN independently pursued PQRS the quality measures or calculate a we proposed that the TIN would retain informal reviews. As stated above, we quality composite score; rather, we the calculated quality or cost tier proposed to reclassify a TIN’s quality would classify the TIN’s quality designation. We made the proposals composite as average quality if it is composite as average quality for the because, after a claims data issue is initially classified as ‘‘low quality’’ in reasons stated above. In this scenario, identified, it would take approximately order to avoid a situation where we do we do not believe that we should retain 6 weeks to recalculate the composites not have the PQRS quality data for those a TIN’s high cost designation when the and notify groups and solo practitioners few EPs whose quality performance TIN’s actual cost performance is not about their recalculated VM. Given that could have bumped the TIN up from a being compared to the TIN’s actual the VM informal review period lasts for low quality designation as the EPs did quality performance, as it is possible the 60 days after the release of the QRURs not meet the criteria to avoid the PQRS TIN might have scored high quality if and the timing of when we become payment adjustment during the initial actual performance had been aware of an error, we would likely not determination. Additionally, it is considered. We would continue to show be able to notify groups and solo important to note that TINs whose EPs and designate these groups as high cost practitioners about their recalculated submit an informal review request in their annual QRURs so they have the VM before the end of the informal would not automatically be covered by opportunity to understand and improve review period. Further, we expressed the policy proposed for Scenario 2. We their performance, but under our our belief that the proposed policies are stated in the CY 2017 PFS proposed rule proposal, we would classify their cost necessary to provide certainty for

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groups and solo practitioners about their Response: We thank the commenters b. Application of the VM to Participant final VM payment adjustment and due for their feedback and support of our TINs in Shared Savings Program ACOs to the condensed timeline to calculate policies. We acknowledge commenters’ That Do Not Complete Quality an accurate VM upward payment concerns about the complexity of the Reporting adjustment factor. underlying data and their suggestions In the CY 2015 PFS final rule with We proposed to apply these policies that we correct the underlying issues, comment period (79 FR 67946), for for the CY 2017 VM and CY 2018 VM. rather than establish policies to address groups and solo practitioners, as The following is a summary of the these scenarios through the informal identified by their TIN, that participate comments we received regarding these proposals. review process. We note that scenarios in a Shared Savings Program ACO, we Comment: Many commenters three and four were proposed to address finalized the same policy that is supported our proposals to modify a unforeseen issues with reported quality generally applicable to groups and solo TIN’s quality and cost composites based data or CMS claims data, respectively. practitioners that fail to satisfactorily on informal review determination or Additionally, we note that as discussed report or participate under PQRS and widespread quality and cost data issues, in this final rule, we expect quality data thus fall in Category 2 and are subject agreeing that assigning ‘‘average issues to be significantly limited moving to an automatic downward adjustment quality’’ would not unfairly penalize forward. We have worked to resolve under the VM in CY 2017. We stated those that fall into these scenarios. PQRS program and receiving system that, consistent with the application of Many of these commenters urged CMS data issues impacting the VM by the VM to other groups and solo to continue efforts to address data reprioritizing scheduled deliverables practitioners that report under PQRS, if integrity and calculation issues. A few and implementing enhancements to the ACO does not successfully report quality data as required by the Shared commenters agreed that limiting the improve 2016 submissions. While some Savings Program under § 425.504, all potential movement between the VM issues may still need to be handled groups and solo practitioners quality tiers based on informal review through the informal review process, would result in a more predictable participating in the ACO will fall in enhanced reporting functionality, with Category 2 for the VM, and therefore, adjustment factor calculation. Some of the removal of constraints around ACO these commenters noted that assignment will be subject to a downward payment reporting outside of a group, will be of an ‘‘average quality’’ designation does adjustment. We finalized this policy for supported by both the program and the not recognize the significant resources the 2017 payment adjustment period for invested by physicians and other receiving system. In 2017, the MIPS the VM. In the CY 2016 PFS proposed eligible professionals in reporting receiving systems will provide further rule (80 FR 41899), we proposed to quality data, particularly through enhanced real-time feedback to continue this policy in the CY 2018 agency-preferred electronic methods. submitters in a more rapid and accurate payment adjustment period for all One commenter suggested CMS could manner to identify errors earlier and groups and solo practitioners subject to shorten the informal review timeframe will further accept the most accurate the VM that participate in a Shared or eliminate mid-year reports, in order data submitted. We are finalizing the Savings Program ACO and finalized our to allow more resources for policies for Scenarios 1, 2, 3 and 4 as proposal in the CY 2016 PFS final rule recalculation of the quality composite. proposed. Additionally we note that with comment period (80 FR 71285). Several commenters were not under Scenarios 1 and 3, consistent As discussed in sections III.H. and supportive of our proposals, stating that with the policy adopted in the CY 2013 III.K.1.e. of this final rule, we proposed CMS should instead correct the PFS final rule with comment period (77 to remove the prohibition on EPs who underlying issues necessitating such FR 69325), for groups of physicians or are part of a group or solo practitioner scenarios, with several expressing solo practitioners classified as average that participates in a Shared Savings added concern that the MIPS program quality/low cost as a result of informal Program ACO, for purposes of PQRS will be even more complex. One review, we would apply an additional reporting for the CY 2017 and CY 2018 commenter stated that the proposed upward payment adjustment of +1.0x to payment adjustments, to report outside changes to the informal review process those that care for high-risk the ACO. As a result of this proposed would hold practices accountable for beneficiaries (as evidenced by the policy, the EPs in groups and those who performance without a mechanism in average HCC risk score of the attributed are solo practitioners would be allowed place to ensure the accuracy of the data, beneficiary population). We note further to report to the PQRS as a group (using thus reclassifying a solo practitioner or that, under Scenarios 2 and 4, for groups one of the group registry, QCDR, or EHR reporting options) or individually (using group practice’s performance based on of physicians or solo practitioners an incomplete understanding of their the registry, QCDR, or EHR reporting classified as high quality/low cost, high performance. Another commenter option) outside of the ACO. This section quality/average cost, or average quality/ believes it is important to hold solo addresses how we proposed to use the practitioners and group practices low cost as a result of informal review, PQRS data reported by EPs outside of harmless from penalties resulting from we would apply an additional upward the ACO for the CY 2018 VM when the errors made by external parties. payment adjustment of +1.0x to those ACO does not successfully report However, they expressed concerns that that care for high-risk beneficiaries (as quality data on behalf of their EPs for solo practitioners and group practices evidenced by the average HCC risk score purposes of PQRS as required by the have no opportunity to resubmit their of the attributed beneficiary Shared Savings Program under data allowing their quality composite population). We would apply this § 425.504. scores to be recalculated to reflect all additional upward +1.0x adjustment, For the CY 2018 payment adjustment the available data. They suggest that this because the results of informal review period, if a Shared Savings Program would deprive them of upward under the policy being finalized here, ACO does not successfully report adjustments to payments because would qualify these solo practitioners quality data on behalf of their EPs for measures were reported or calculated and groups for the additional upward purposes of PQRS as required by the inaccurately through no fault of their adjustment, based on the policy Shared Savings Program under own. previously finalized at 77 FR 69325. § 425.504, then we proposed to use the

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data reported to the PQRS by the EPs successfully report quality data as As discussed in section III.H. of this under the participant TIN (as a group required by the Shared Savings Program final rule, to allow affected EPs that (using one of the group registry, QCDR, under § 425.504 and are in Category 1 as participate in an ACO to report or EHR reporting options) or as a result of reporting quality data to the separately for the CY 2017 PQRS individuals (using the registry, QCDR, PQRS outside of the ACO, we would payment adjustment, we proposed a or EHR reporting option)) outside of the classify their quality composite for the secondary PQRS reporting period for ACO to determine whether the TIN VM for the CY 2018 payment EPs that were in an ACO that did not would fall in Category 1 or Category 2 adjustment period as ‘‘average quality successfully report quality data on under the VM. We proposed to apply (81 FR 46447).’’ As finalized in the CY behalf of the EPs in the group and those the two-category approach finalized for 2015 PFS final rule with comment who are solo practitioners. Specifically, the CY 2018 VM (80 FR 71280) based on period (79 FR 67943), the cost we proposed that affected individual participation in the PQRS by groups and composite for groups and solo EPs or groups, who report under an solo practitioners to determine whether practitioners that participate in a Shared ACO, may separately report outside the groups and solo practitioners that Savings Program ACO will be classified ACO either as individual EPs (using the participate in a Shared Savings Program as ‘‘average cost.’’ Because we would registry, QCDR, or EHR reporting ACO, but report to the PQRS outside of not have the ACO’s quality data for option) or using one of the group the ACO, would fall in Category 1 or these groups and solo practitioners, we registry, QCDR, or EHR reporting Category 2 under the VM. We noted that expressed our belief that it would be options (note these EPs and groups the proposed policy was consistent with appropriate to use the quality data they would not need to register for one of our policy for groups and solo reported to the PQRS outside the ACO these group reporting options, but rather practitioners who are subject to the VM to determine whether they avoided the could mark the data as group-level data and do not participate in the Shared PQRS payment adjustment and whether in their submission) during a secondary PQRS reporting period for the CY 2017 Savings Program, and we believe it they would be in Category 1 or 2 for PQRS payment adjustment if they were would further encourage quality purposes of the VM, but not to calculate reporting by EPs in the event the ACO a participant in an ACO that did not a quality composite using the quality- does not successfully report quality data successfully report quality data on their tiering methodology. As we stated as required by the Shared Savings behalf during the established reporting previously, we continue to believe that Program under § 425.504. For example, period for the CY 2017 PQRS payment it is appropriate to calculate a quality if groups that participate in a Shared adjustment. We proposed the secondary composite for groups and solo Savings Program ACO in 2016 report PQRS reporting period for the CY 2017 quality data to the PQRS outside of the practitioners participating in the Shared PQRS payment adjustment would ACO and meet the criteria to avoid Savings Program based on the ACO’s coincide with the reporting period for PQRS payment adjustment for CY 2018 quality data (79 FR 67944). We noted the CY 2018 PQRS payment adjustment as a group using one of the group that the proposal was not intended to (that is, January 1, 2016 through registry, QCDR, or EHR reporting encourage groups and solo practitioners December 31, 2016). that participate in a Shared Savings options or have at least 50 percent of the This section addresses how we Program ACO to report to the PQRS group’s EPs meet the criteria to avoid proposed to use, for purposes of the CY outside the ACO, but in the event the the PQRS payment adjustment for CY 2017 VM, the PQRS data reported by the 2018 as individuals using the registry, ACO does not successfully report EPs in the group and those who are solo QCDR, or EHR reporting option by quality data on behalf of their EPs for practitioners outside of the ACO using reporting quality data to PQRS outside purposes of PQRS, to provide them with the secondary PQRS reporting period of the ACO, then they would be a safeguard that would allow them to when the ACO did not successfully included in Category 1 for the CY 2018 avoid the PQRS payment adjustment report quality data on behalf of their EPs VM. If solo practitioners that participate and the automatic downward for purposes of PQRS as required by the in a Shared Savings Program ACO in adjustment under the VM. We Shared Savings Program under 2016 report quality data to the PQRS encourage groups and solo practitioners § 425.504 for the CY 2017 PQRS outside of the ACO and meet the criteria to continue to report through the ACO payment adjustment. For the CY 2017 to avoid the PQRS payment adjustment in order to promote clinical and payment adjustment period, if a Shared for CY 2018 as individuals using the financial integration within the ACO Savings Program ACO did not registry, QCDR, or EHR reporting and for the Medicare beneficiaries they successfully report quality data on option, then they would also be treat. For groups and solo practitioners behalf of their EPs for purposes of PQRS included in Category 1. Category 2 that participate in a Shared Savings as required by the Shared Savings would include those groups and solo Program ACO that successfully reports Program under § 425.504 for the CY practitioners subject to the CY 2018 VM quality data on behalf of their EPs for 2017 PQRS payment adjustment, then that participate in a Shared Savings purposes of PQRS as required by the we propose to use the data reported to Program ACO and do not fall within Shared Savings Program under the PQRS by the EPs (as a group using Category 1. § 425.504, we will calculate their VM for one of the group registry, QCDR, or EHR As finalized for the CY 2018 payment the CY 2018 payment adjustment period reporting options or as individuals adjustment period (80 FR 71285), all according to the policies established in using the registry, QCDR, or EHR groups and solo practitioners that the CY 2015 PFS final rule with reporting option) under the participant participate in a Shared Savings Program comment period (79 FR 67941 to 67947 TIN) outside of the ACO during the ACO and fall in Category 2 will be and 79 FR 67956 to 67957) and CY 2016 secondary PQRS reporting period to subject to an automatic downward PFS final rule with comment period (80 determine whether the TIN would fall payment adjustment under the VM. In FR 71283 to 71286 and 80 FR 71294). in Category 1 or Category 2 under the the CY 2017 PFS proposed rule, we We solicited comment on these VM. We proposed to apply the two- proposed that, for groups and solo proposals and also proposed category approach finalized for the CY practitioners that participate in a Shared corresponding revisions to 2017 VM (79 FR 67938 to 67939 and as Savings Program ACO that did not § 414.1210(b)(2). revised in 80 FR 71280 to 71281) based

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on participation in the PQRS by groups Savings Program ACO will be classified the ACO, and therefore, should not be and solo practitioners to determine as ‘‘average cost.’’ penalized if the ACO does not whether groups and solo practitioners If EPs who are part of a group or are successfully report quality data. One that participate in a Shared Savings solo practitioners who participated in a commenter also stated that if the EPs Program ACO, but report to the PQRS Shared Savings Program ACO in 2015 had been aware of the option earlier in outside of the ACO, would fall in that did not successfully report quality the 2016 reporting period, it would be Category 1 or Category 2 under the VM. data on their behalf decide to use the a more viable proposal. As discussed in section III.H. of this secondary PQRS reporting period, it is Response: As discussed in sections final rule, we proposed to assess the important to note that such groups and III.H. and III.K.1.e. of this final rule, we individual EP or group’s 2016 data solo practitioners should expect to be are finalizing our proposals to remove submitted outside the ACO and during initially classified as Category 2 and the prohibition on EPs who are part of the secondary PQRS reporting period receive an automatic downward a group or solo practitioner that against the reporting requirements for adjustment under the VM for items and participates in a Shared Savings services furnished in CY 2017 until Program ACO, for purposes of PQRS the CY 2018 PQRS payment adjustment. CMS is able to determine whether the reporting for the CY 2017 and CY 2018 Therefore, we proposed that groups that group or solo practitioner met the payment adjustments, to report outside meet the criteria to avoid PQRS criteria to avoid the PQRS payment the ACO. As discussed in section III.H. payment adjustment for CY 2018 as a adjustment as described above. First, we of this final rule, to allow affected EPs group practice participating in the PQRS would need to process the data that participate in an ACO to report GPRO (using one of the group registry, submitted for 2016. Second, we would separately for the CY 2017 PQRS QCDR, or EHR reporting options) or need to determine whether or not the payment adjustment, we are finalizing have at least 50 percent of the group’s group or solo practitioner would be our proposal to create a secondary PQRS EPs meet the criteria to avoid the PQRS classified as Category 1 or Category 2 for reporting period for EPs that were in an payment adjustment for CY 2018 as the CY 2017 VM and notify the group ACO that did not successfully report individuals (using the registry, QCDR, or solo practitioner if there is a change quality data on behalf of the EPs in the or EHR reporting option), based on data in the VM status. Third, we would need group and those who are solo submitted outside the ACO and during to update the group or solo practitioners. Specifically, in section the secondary PQRS reporting period, practitioner’s status so that they will III.H. of this final rule, we are finalizing would be included in Category 1 for the stop receiving an automatic downward that affected individual EPs or groups, CY 2017 VM. We also proposed that adjustment under the VM for items and who report under an ACO, may solo practitioners that meet the criteria services furnished in CY 2017 and separately report outside the ACO either to avoid the PQRS payment adjustment reprocess all claims that were as individual EPs (using the registry, for CY 2018 as individuals using the previously paid. Since groups and solo QCDR, or EHR reporting option) or registry, QCDR, or EHR reporting practitioners taking advantage of this using one of the group registry, QCDR, option, based on data submitted outside secondary reporting period for the 2017 or EHR reporting options (note these the ACO and during the secondary VM will have missed the deadline for EPs and groups would not need to PQRS reporting period, would be submitting an informal review request register for one of these group reporting included in Category 1 for the CY 2017 for the 2017 VM, we proposed the options, but rather mark the data as VM. Category 2 would include those informal review submission periods for group data in their submission) during groups and solo practitioners subject to these groups and solo practitioners a secondary PQRS reporting period for the CY 2017 VM that participate in a would occur during the 60 days the CY 2017 PQRS payment adjustment Shared Savings Program ACO and do following the release of the QRURs for if they were a participant in an ACO not fall within Category 1. the 2018 VM. that did not successfully report quality We requested comment on these data on their behalf during the As finalized for the CY 2017 payment proposals. We also proposed established reporting period for the CY adjustment period (79 FR 67946), all corresponding revisions to 2017 PQRS payment adjustment. We are groups and solo practitioners that § 414.1210(b)(2). also finalizing in section III.H. of this participate in a Shared Savings Program The following is a summary of the final rule that the secondary PQRS ACO and fall in Category 2 will be comments we received regarding these reporting period for the CY 2017 PQRS subject to an automatic downward proposals. payment adjustment would coincide payment adjustment under the VM. For Comment: Commenters supported our with the reporting period for the CY groups and solo practitioners that proposals to use the PQRS data reported 2018 PQRS payment adjustment (that is, participate in a Shared Savings Program by EPs outside of the ACO for the CY January 1, 2016, through December 31, ACO that did not successfully report 2017 and CY 2018 VM when the ACO 2016). quality data as required by the Shared does not successfully report quality data We appreciate the commenters’ Savings Program under § 425.504 and on behalf of its EPs for purposes of support of our proposal to use the PQRS are in Category 1 as a result of reporting PQRS as required by the Shared Savings data reported by EPs outside of the ACO quality data to the PQRS outside of the Program under § 425.504. Several for the CY 2017 and CY 2018 VM when ACO using the secondary PQRS commenters requested that CMS the ACO does not successfully report reporting period, we propose to classify consider holding these EPs harmless quality data on behalf of its EPs and are their quality composite for the VM for from VM adjustments for both the 2017 finalizing the policies as proposed. We the CY 2017 payment adjustment period and 2018 payment adjustment years. plan to communicate with the ACOs as ‘‘average quality’’ for the same Commenters stated EPs would not know (and their participant TINs) that did not reasons described above for the CY 2018 if the ACO failed to report for PQRS successfully report quality data on payment adjustment period. As until close to the end of the reporting behalf of their EPs for purposes of PQRS finalized in the CY 2015 PFS final rule period which would not allow sufficient for the CY 2017 PQRS payment with comment period (79 FR 67943), the time for them to report separately. In adjustment to inform them about the cost composite for groups and solo addition, commenters stated EPs are not reporting during the secondary PQRS practitioners that participate in a Shared in direct control of decisions made by reporting period. We encourage EPs to

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communicate with their ACO and report PQRS by the EPs under the participant separately from the ACO. One quality data in the event the ACO does TIN (as a group using one of the group commenter stated that, for the 2018 VM, not successfully report quality data as registry, QCDR, or EHR reporting in cases where measures are submitted required by the Shared Savings Program options or as individuals using the by both the EP and the ACO, the best under § 425.504 for the CY 2018 PQRS registry, QCDR, or EHR reporting performance be counted and the EP payment adjustment. option) outside of the ACO during the should be eligible for a payment For the CY 2018 payment adjustment secondary PQRS reporting period to adjustment based on performance; and period, we are finalizing that, if a determine whether the TIN would fall in cases where the EP opts to report Shared Savings Program ACO does not in Category 1 or Category 2 under the through an ACO, but the ACO fails to successfully report quality data on VM. We are also finalizing that we will report, the EP should receive a neutral behalf of their EPs for purposes of PQRS apply the two-category approach payment adjustment. One commenter as required by the Shared Savings finalized for the CY 2017 VM (79 FR supported our proposal to classify the Program under § 425.504, then we will 67938 to 67939 and as revised in 80 FR quality composite of TINs that report use the data reported to the PQRS by the 71280 to 71281) based on participation outside of the ACO as ‘‘average quality’’ EPs under the participant TIN (as a in the PQRS by groups and solo for the CY 2018 VM. group (using one of the group registry, practitioners to determine whether Response: As we stated previously, QCDR, or EHR reporting options) or as groups and solo practitioners that we continue to believe that it is individuals (using the registry, QCDR, participate in a Shared Savings Program appropriate to calculate a quality or EHR reporting option) outside of the ACO, but report to the PQRS outside of composite for groups and solo ACO to determine whether the TIN the ACO, would fall in Category 1 or practitioners participating in the Shared would fall in Category 1 or Category 2 Category 2 under the VM. In section Savings Program based on the ACO’s under the VM. We are also finalizing III.H. of this final rule, we finalized that quality data (79 FR 67944). Our that we will apply the two-category we will assess the individual EP or proposed policies were not intended to approach finalized for the CY 2018 VM group’s 2016 data submitted outside the encourage groups and solo practitioners (80 FR 71280) based on participation in ACO and during the secondary PQRS that participate in a Shared Savings the PQRS by groups and solo reporting period against the reporting Program ACO to report to the PQRS practitioners to determine whether requirements for the CY 2018 PQRS outside the ACO, but in the event the groups and solo practitioners that payment adjustment. Therefore, we are ACO does not successfully report participate in a Shared Savings Program also finalizing that groups that meet the quality data on behalf of their EPs for ACO, but report to the PQRS outside of criteria to avoid PQRS payment purposes of PQRS, to provide them with the ACO, would fall in Category 1 or adjustment for CY 2018 as a group a safeguard that would allow them to Category 2 under the VM. Thus, if practice participating in the PQRS avoid the PQRS payment adjustment groups that participate in a Shared GPRO (using one of the group registry, and the automatic downward Savings Program ACO in 2016 report QCDR, or EHR reporting options) or adjustment under the VM. We quality data to the PQRS outside of the have at least 50 percent of the group’s encourage groups and solo practitioners ACO and meet the criteria to avoid EPs meet the criteria to avoid the PQRS to continue to report through the ACO PQRS payment adjustment for CY 2018 payment adjustment for CY 2018 as in order to promote clinical and as a group using one of the group individuals (using the registry, QCDR, financial integration within the ACO and for the Medicare beneficiaries they registry, QCDR, or EHR reporting or EHR reporting option), based on data options or have at least 50 percent of the treat. submitted outside the ACO and during group’s EPs meet the criteria to avoid Therefore, we are finalizing as the secondary PQRS reporting period, the PQRS payment adjustment for CY proposed that, for groups and solo will be included in Category 1 for the 2018 as individuals using the registry, practitioners that participate in a Shared CY 2017 VM. We are also finalizing that QCDR, or EHR reporting option by Savings Program ACO that did not solo practitioners that meet the criteria reporting quality data to PQRS outside successfully report quality data as to avoid the PQRS payment adjustment of the ACO, then they will be included required by the Shared Savings Program for CY 2018 as individuals using the in Category 1 for the CY 2018 VM. If under § 425.504 and are in Category 1 as registry, QCDR, or EHR reporting solo practitioners that participate in a a result of reporting quality data to the option, based on data submitted outside Shared Savings Program ACO in 2016 PQRS outside of the ACO, we will report quality data to the PQRS outside the ACO and during the secondary classify their quality composite for the of the ACO and meet the criteria to PQRS reporting period, will be included VM for the CY 2018 payment avoid the PQRS payment adjustment for in Category 1 for the CY 2017 VM. adjustment period as ‘‘average quality.’’ CY 2018 as individuals using the Category 2 will include those groups We are also finalizing that for groups registry, QCDR, or EHR reporting and solo practitioners subject to the CY and solo practitioners that participate in option, then they will also be included 2017 VM that participate in a Shared a Shared Savings Program ACO that did in Category 1. Category 2 will include Savings Program ACO and do not fall not successfully report quality data as those groups and solo practitioners within Category 1. required by the Shared Savings Program subject to the CY 2018 VM that Comment: Several commenters under § 425.504 and are in Category 1 as participate in a Shared Savings Program supported our proposal to classify the a result of reporting quality data to the ACO and do not fall within Category 1. quality composite of TINs that report PQRS outside of the ACO using the For the CY 2017 payment adjustment outside of the ACO as ‘‘average quality’’ secondary PQRS reporting period, we period, we are finalizing that, if a for the CY 2017 VM so that these EPs will classify their quality composite for Shared Savings Program ACO did not are protected from downward the VM for the CY 2017 payment successfully report quality data on adjustments under quality-tiering; adjustment period as ‘‘average quality’’. behalf of their EPs for purposes of PQRS however, few commenters stated that it As finalized in the CY 2015 PFS final as required by the Shared Savings would be appropriate to apply the rule with comment period (79 FR Program under § 425.504 for the CY quality-tiering methodology for the 2018 67943), the cost composite for groups 2017 PQRS payment adjustment, then VM payment adjustment when TINs in and solo practitioners that participate in we will use the data reported to the the Shared Savings Program report a Shared Savings Program ACO will be

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classified as ‘‘average cost.’’ We are also Section 13562 of the Omnibus Budget the physician self-referral regulations, finalizing the corresponding revisions to Reconciliation Act of 1993 (Pub. L. 103– including provisions that prohibited § 414.1210(b)(2). 66) (OBRA 1993), enacted on August 10, certain per unit-of-service (often Since groups and solo practitioners 1993, expanded the referral prohibition referred to as ‘‘per-click’’) and taking advantage of the secondary PQRS to cover certain other ‘‘designated percentage-based compensation reporting period for the CY 2017 PQRS health services’’ in addition to clinical formulas for determining the rental payment adjustment will have missed laboratory services, modified some of charges for office space and equipment the deadline for submitting an informal the existing statutory exceptions, and lease arrangements. review request for the 2017 VM, we added new exceptions. Section 152 of We issued additional final regulations proposed the informal review the Social Security Act Amendments of after passage of the Affordable Care Act. submission periods for these groups and 1994 (SSA 1994) (Pub. L. 103–432), In the CY 2011 PFS final rule with solo practitioners would occur during enacted on October 31, 1994, amended comment period (75 FR 73170), we the 60 days following the release of the the list of designated health services, codified a disclosure requirement QRURs for the 2018 VM. We did not changed the reporting requirements at established by the Affordable Care Act receive any comments on this proposal section 1877(f) of the Act, and modified for the in-office ancillary services and are finalizing this policy as some of the effective dates established exception. We also issued regulations in proposed. by OBRA 1993. Some provisions the CY 2011 OPPS final rule with relating to referrals for clinical comment period (75 FR 71800), the CY M. Physician Self-referral Updates laboratory services were effective 2012 OPPS final rule with comment 1. Unit-based Compensation in retroactively to January 1, 1992, while period (76 FR 74122), and the CY 2015 Arrangements for the Rental of Office other provisions became effective on OPPS final rule with comment period Space or Equipment January 1, 1995. (79 FR 66770) that established or revised certain regulatory provisions a. The Physician Self-referral Statute (2) Regulatory History concerning physician-owned hospitals and Regulations (a) General Background to codify and interpret the Affordable (1) Section 1877 of the Act Care Act’s revisions to section 1877 of The following discussion provides a the Act. Finally, in the CY 2016 PFS Section 6204 of the Omnibus Budget chronology of our more significant and final rule (80 FR 70886), we issued Reconciliation Act of 1989 (Pub. L. 101– comprehensive rulemakings; it is not an regulations to accommodate delivery 239) (OBRA 1989), enacted on exhaustive list of all rulemakings related and payment system reform, reduce December 19, 1989, added section 1877 to the physician self-referral law. burden, and to facilitate compliance. In to the Act. Section 1877 of the Act, also Following the passage of section 1877 that rulemaking, we established two known as the physician self-referral law: of the Act, we proposed rulemakings in new exceptions, clarified certain (1) Prohibits a physician from making 1992 (related only to referrals for provisions of the physician self-referral referrals for certain designated health clinical laboratory services) (57 FR law, updated regulations to reflect services (DHS) payable by Medicare to 8588) (the 1992 proposed rule) and 1998 changes in terminology, and revised an entity with which he or she (or an (addressing referrals for all DHS) (63 FR definitions related to physician-owned immediate family member) has a 1659) (the 1998 proposed rule). We hospitals. One of the new exceptions, financial relationship (ownership or finalized the proposals from the 1992 the exception for timeshare compensation), unless an exception proposed rule in 1995 (60 FR 41914) arrangements at § 411.357(y), includes a applies; and (2) prohibits the entity from (the 1995 final rule), and issued final prohibition on certain per unit-of- filing claims with Medicare (or billing rules following the 1998 proposed rule service compensation formulas. another individual, entity, or third party in three stages. The first final payer) for those referred services. The rulemaking (Phase I) was published in (b) Unit-based Compensation statute establishes a number of specific the January 4, 2001 Federal Register (66 We have addressed the issue of unit- exceptions, and grants the Secretary the FR 856) as a final rule with comment based compensation in several authority to create regulatory exceptions period. The second final rulemaking rulemakings. Sections 1877(e)(1)(A)(iv) for financial relationships that pose no (Phase II) was published in the March and (B)(iv) of the Act provide that, for risk of program or patient abuse. 26, 2004 Federal Register (69 FR 16054) an arrangement for the rental of office Additionally, the statute mandates as an interim final rule with comment space or equipment to satisfy the refunding any amount collected under a period. Due to a printing error, a portion relevant exceptions to the physician bill for an item or service furnished of the Phase II preamble was omitted self-referral law, the rental charges over under a prohibited referral. Finally, the from the March 26, 2004 Federal the term of the lease must be set in statute imposes reporting requirements Register publication. That portion of the advance, be consistent with fair market and provides for sanctions, including preamble, which addressed reporting value, and not be determined in a civil monetary penalty provisions. requirements and sanctions, was manner that takes into account the Section 1877 of the Act became effective published on April 6, 2004 (69 FR volume or value of any referrals or other on January 1, 1992. 17933). The third final rulemaking business generated between the parties. Section 4207(e) of the Omnibus (Phase III) was published in the Interpreting this ‘‘volume or value’’ Budget Reconciliation Act of 1990 (Pub. September 5, 2007 Federal Register (72 standard in the 1998 proposed rule, we L. 101–508) (OBRA 1990), enacted on FR 51012) as a final rule. In addition to proposed that compensation could be November 5, 1990, amended certain Phase I, Phase II, and Phase III, we based on units of service (for example, provisions of section 1877 of the Act to issued final regulations on August 19, ‘‘per-use’’ equipment rentals) provided clarify definitions and reporting 2008 in the ‘‘Changes to the Hospital that the units of service did not include requirements relating to physician Inpatient Prospective Payment Systems services provided to patients who were ownership and referrals and to provide and Fiscal Year 2009 Rates’’ final rule referred by the physician receiving the an additional exception to the with comment period (73 FR 48434) (the payment. For example, a physician who prohibition. Several subsequent laws FY 2009 IPPS final rule). That owned a lithotripter could rent it to a further changed section 1877 of the Act. rulemaking made various revisions to hospital on a per-procedure basis,

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except for lithotripsies for patients refers a patient to the lessee for a service and (p) for fair market value referred by the physician owner. performed in the leased office space or compensation and indirect Instead, payments for the use of the using the leased equipment have an compensation arrangements, lithotripter for those patients would obvious potential for abuse and could respectively, to include similar have to use a methodology that did not incent overutilization (66 FR 878). We limitations on the formula for vary with referrals. (63 FR 1714; see also indicated that we would continue to determining office space and equipment 66 FR 876). We further proposed that monitor financial arrangements in the rental charges, as applicable. We did so arrangements in which a physician rents health care industry and would revisit using our authority at section 1877(b)(4) equipment to an entity that furnishes a particular regulatory decisions if we of the Act, as those exceptions were designated health service, such as a determine that there has been abuse or established using that authority (See 73 hospital that rents an MRI machine, overutilization (66 FR 860). FR 48713 through 48721). We with the physician receiving rental In the CY 2008 PFS proposed rule (72 determined it necessary to limit the type payments on a ‘‘per-use’’ or ‘‘per-click’’ FR 38122), we stated that arrangements of per-click compensation formulas basis (that is, a rental payment is between a physician lessor and an entity available for arrangements for the rental generated each time the machine is lessee under which the physician lessor of office space and equipment because used) do not prohibit the physician from receives unit-of-service payments are we believe that arrangements under otherwise referring to the entity, inherently susceptible to abuse because which a lessor receives unit-of-service provided that these kinds of the physician lessor has an incentive to payments are inherently susceptible to arrangements are typical and comply profit from referring a higher volume of abuse. Specifically, we believe that the with the fair market value and other patients to the lessee. We proposed that lessor has an incentive to profit from standards that are included under the space and equipment leases may not referring a higher volume of patients to rental exception. However, because a include per-click payments to a the lessee and from referring patients to physician’s compensation under this physician lessor for services rendered the lessee that might otherwise go exception cannot reflect the volume or by an entity lessee to patients who are elsewhere for services. referred by a physician lessor to the value of the physician’s own referrals, b. Development of This Rulemaking we proposed that the rental payments entity (72 FR 38183). We also solicited may not reflect ‘‘per-use’’ or ‘‘per-click’’ comments on the question of whether (1) Council for Urological Interests v. payments for patients who are referred we should prevent per-click payments Burwell for the service by the physician lessor in situations in which the physician is On June 12, 2015, the D.C. Circuit (the (63 FR 1714). the lessee and a DHS entity is the lessor. Court) issued an opinion in Council for The CY 2008 PFS proposed rule also After reviewing the public comments Urological Interests v. Burwell, 790 F.3d included eight other significant 212 (D.C. Cir. 2015), that addressed the in response to the 1998 proposed rule, proposed revisions to the physician self- we finalized in Phase I significant prohibition on per-click rental charges referral regulations. Due to the large for the lease of equipment found at revisions with respect to the scope of number of physician self-referral the volume or value standard. We § 411.357(b)(4)(ii)(B). In its ruling, the proposals, the significance of the Court agreed with CMS that section revised our interpretation of the provisions both individually and in ‘‘volume or value’’ standard for 1877(e)(1)(B)(vi) of the Act provides the concert with each other, and the volume Secretary the authority to prohibit per- purposes of section 1877 of the Act to of public comments received in permit, among other things, payments click leasing arrangements. The Court response to the CY 2008 PFS proposed concluded that— based on a unit of service, provided that rule, we declined to finalize our the unit-based payment is fair market proposals, including our proposal to The text of the statute does not value and does not vary over time (66 unambiguously preclude the Secretary from prohibit certain per unit-of-service using her authority to add a requirement that FR 876 through 879). Importantly, we compensation formulas in arrangements permitted unit-based compensation bans per-click leases. To the contrary, the for the rental of office space and statutory text of the exception clearly formulas, even when the physician equipment, in the CY 2008 PFS final provides the Secretary with the discretion to receiving the payment has generated the rule (72 FR 66222). impose any additional requirements that she payment through a DHS referral. To After consideration of the public deems necessary ‘‘to protect against program reach this position, we noted that page comments and our independent or patient abuse.’’ (Council for Urological 814 of the House Conference Committee research, we finalized regulations Interests, 790 F.3d at 219.) report (H. Rep. No. 213, 103rd Cong., 1st prohibiting certain per-unit of service The Court further concluded that the Sess. (1993)) stated, with respect to the compensation formulas for determining relevant language in the House statutory exceptions for the rental of office space and equipment rental Conference Report merely interpreted office space and equipment in sections charges in the FY 2009 IPPS final rule section 1877(e)(1)(B)(iv) of the Act, and 1877(e)(1)(A)(iv) and (B)(iv) of the Act, (73 FR 48434). Specifically, we revised thus did not preclude CMS from that the conferees ‘‘intend[ed] that § 411.357(a)(4) and (b)(4) to prohibit imposing additional requirements under rental charges for [office] space and rental charges for the rental of office section 1877(e)(1)(B)(vi) of the Act. It equipment leases may be based on space or equipment that are determined stated that the legislative history daily, monthly, or other time-based using a formula based on per-unit of ‘‘simply indicates that, as written, the rates, or rates based on units of service service rental charges, to the extent that rental-charge clause [in section furnished, so long as the amount of the such charges reflect services provided to 1877(e)(1)(B)(iv) of the Act] does not time-based or units of service rates does patients referred by the lessor to the preclude per-click leases’’ and stated not fluctuate during the contract period lessee. In doing so, we relied on our further that ‘‘[n]othing in the legislative based on the volume or value of authority in section 1877(e)(1)(A)(vi) history suggests a limit on [the referrals between the parties to the lease and (B)(vi) of the Act, which permits the Secretary’s] authority’’ to prohibit per- or arrangement.’’ (66 FR 876). However, secretary to impose by regulation other click leases under section we stated our unequivocal belief that requirements needed to protect against 1877(e)(1)(B)(vi) of the Act (Id. at 222.). arrangements in which the lessor is program or patient abuse. We also The Court also concluded, however, compensated each time that the lessor revised the exceptions at §§ 411.357(l) that CMS’s discussion of the House

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Conference Report in the FY 2009 IPPS rent (that is, the rental charges) over the proposed to limit, and in this final rule final rule contained an unreasonable term of the lease is directly affected by are finalizing a limit on, the general rule interpretation of the conferees’ the number of patients referred by one by prohibiting per-unit of service rental statements concerning sections party to the other, those rental charges charges where the lessor generates the 1877(e)(1)(A)(iv) and (B)(iv) of the Act, can arguably be said to ‘‘take into payment from the lessee through a and it remanded the case to the agency account’’ or ‘‘fluctuate during the referral to the lessee for a service to be to permit a fuller consideration of the contract period based on’’ the volume or provided in the rented office space or legislative history. This rulemaking value of referrals between the parties. using the rented equipment. Thus, addresses that decision. The Court found this revised under this final rule, per-unit of service interpretation to be an unreasonable rental charges for the rental of office (2) The FY 2009 IPPS Final Rule reading of the language of the House space or equipment are permissible, but As discussed above, in the FY 2009 Conference Report. The Court remanded only in those instances where the IPPS final rule, we revised the § 411.357(b)(4)(ii)(B) to the Secretary for referral for the service to be provided in exceptions for the rental of office space further proceedings consistent with its the rented office space or using the and equipment to include in each a opinion, and directed that the Secretary rented equipment did not come from the requirement that the rental charges for should consider whether a ban on per- lessor. the office space or equipment are not click equipment leases is consistent (1) Authority determined using a formula based on with the House Conference Report. per-unit of service rental charges, to the c. The CY 2017 PFS Proposed Rule: In accordance with the Court’s extent that such charges reflect services Re-proposal of Limitation on the Types opinion in Council for Urological provided to patients referred by the of Per-unit of Service Compensation Interests, in the proposed rule, we set lessor to the lessee. We explained that Formulas for Determining Office Space forth the Secretary’s authority to include our decision to add this requirement and Equipment Rental Charges in the exceptions applicable to office was ultimately based on our authority In the CY 2017 PFS proposed rule, we space and equipment leases a under section 1877(e)(1)(B)(vi) of the proposed certain requirements for requirement that rental charges are not Act to promulgate ‘‘other requirements’’ arrangements involving the rental of determined using a formula based on needed to protect against program or office space or equipment. Specifically, per-unit of service rental charges that patient abuse. However, we also using the same language in existing reflect services provided to patients discussed certain legislative history § 411.357(a)(5)(ii)(B), (b)(4)(ii)(B), referred by the lessor to the lessee. Our contained in the House Conference (l)(3)(ii), and (p)(1)(ii)(B), we proposed determination followed the Court’s Report addressing sections to include at § 411.357(a)(5)(ii)(B), reasoning, excerpted below, in rejecting 1877(e)(1)(A)(iv) and 1877(e)(1)(B)(iv) of (b)(4)(ii)(B), (l)(3)(ii), and (p)(1)(ii)(B) a the Council for Urological Interests’ the Act, which establish requirements requirement that rental charges for the assertion that the Secretary lacked the that rental charges over the term of a lease of office space or equipment are authority to impose a ban on ‘‘per-click’’ lease for office space or rental not determined using a formula based equipment—and by correlation—office equipment be set in advance, be on per-unit of service rental charges, to space leases. We also described why consistent with fair market value, and the extent that such charges reflect limiting the types of per-click rental not be determined in a manner that services provided to patients referred by charges that would not violate the takes into account the volume or value the lessor to the lessee. We used the physician self-referral law’s referral and of any referrals or other business authority granted to the Secretary in claims submission prohibitions is generated between the parties. With sections 1877(e)(1)(A)(vi) and (B)(vi) of consistent with the language of the respect to those statutory conditions, the the Act to re-propose this requirement House Conference Report. language in the House Conference in the exceptions at § 411.357(a) and (b) As the Court stated, the physician Report states that— for the rental of office space and self-referral law gives the Secretary equipment, respectively. We used the power to add requirements as needed to The conferees intend that charges for space authority granted to the Secretary in protect against program or patient and equipment leases may be based on daily, monthly, or other time-based rates, or rates section 1877(b)(4) of the Act to re- abuse, even if Congress did not based on units of service furnished, so long propose this requirement in the anticipate such abuses at the time of as the amount of time-based or units of exceptions at § 411.357(l) and (p) for fair enactment of the statute. Specifically, service rates does not fluctuate during the market value compensation and indirect although Congress may not have contract period based on the volume or value compensation arrangements, originally included a ban on per-click of referrals between the parties to the lease respectively. For the reasons set forth rental charges in office space and or arrangement. (H.R. Rep. No. 103–213, at below, we are finalizing without equipment lease arrangements, it 814 (1993).) modification at § 411.357(a)(5)(ii)(B), ‘‘empowered the Secretary to make her In the FY 2009 IPPS final rule, we (b)(4)(ii)(B), (l)(3)(ii), and (p)(1)(ii)(B) a own assessment of the needs of the noted that CMS had previously requirement that rental charges for the Medicare program and regulate concluded that this language indicated lease of office space or equipment are accordingly.’’ (Council for Urological that Congress intended to permit leases not determined using a formula based Interests, 790 F.3d at 220.) The statute that included per-click payments, even on per-unit of service rental charges, to explicitly permits the Secretary to for patients referred by the physician the extent that such charges reflect impose additional conditions on lessor (66 FR 940), but stated that the services provided to patients referred by arrangements for the rental of office language could also be interpreted as the lessor to the lessee. space or equipment, and nowhere excluding from the office space and We emphasize that we did not expressly states that per-click rates must equipment lease exceptions those lease propose and are not finalizing an always be permitted. Thus, as the Court arrangements that include per-click absolute prohibition on rental charges confirmed, the Secretary’s regulation payments for services provided to based on units of service furnished. In limiting the use of per-click patients referred from one party to the general, per-unit of service rental compensation formulas ‘‘can properly other (73 FR 48716). Specifically, we charges for the rental of office space or be classified as an ‘other’ requirement stated that, where the total amount of equipment are permissible. We expressly permitted by sections

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1877(e)(1)(A)(vi) and (B)(vi) of the Act.’’ charges as she reevaluates, in light of Act], Congress created an exception to the (Id.) experience, the operation of the statute [physician self-referral law] that allows the The Secretary’s authority to impose and the need to protect the Medicare continuation of certain group practice requirements regarding the type of program and its beneficiaries against arrangements with a hospital.... The compensation formulas upon which provision states that ‘‘[a]n arrangement abuse. (Id. at 222 n.7; see also id. at 222 between a hospital and a group under which office space and equipment rental n.6 (‘‘Congress has expressly delegated designated health services are provided by charges may be based is not constrained to the Secretary the authority to the group but are billed by the hospital’’ is by the House Conference Report. In the promulgate additional requirements, as excepted from the ban on referrals if, among proposed rule, we acknowledged that she has done here, and the legislative other things, ‘‘the compensation paid over the language in the House Conference history does not clearly impose a the term of the agreement is consistent with Report states Congress’ intent at the constraint on that power.’’).) fair market value and the compensation per time of enactment of the physician self- In the proposed rule, we discussed unit of services is fixed in advance and is not referral law that sections determined in a manner that takes into the Secretary’s broad authority under account the volume or value of any referrals 1877(e)(1)(A)(iv) and (B)(iv) of the Act sections 1877(e)(1)(A)(vi) and (B)(vi) of or other business generated between the not be interpreted as prohibiting charges the Act to impose conditions on parties.’’ Comparing this provision to the for the rental of office space or arrangements for the rental of office [exceptions for the rental of office space and equipment that are based on units of space or equipment in order to protect equipment] shows that Congress knew how service furnished. We did not purport to against program or patient abuse. That to permit per-click payments explicitly, interpret this language as implying authority is not limited by the express suggesting that the omission in this particular anything other than the conferees’ words of the statute as it is in other context was deliberate.... In other words, understanding—at the time of provisions of section 1877 of the Act. In Congress’s decision not to include similar enactment of the statute—that the language in the [exceptions for the rental of agreement, the Court in Council for office space and equipment] supports our statute as written did not prohibit rental Urological Interests explained— conclusion that the statute is silent regarding charges based on units of service rates. . . . Congress knew how to limit the the permissibility of per-click leases for But Congress also gave the Secretary the Secretary’s authority to impose additional equipment rentals. (790 F.3d at 220–21 authority in sections 1877(e)(1)(A)(vi) requirements to the various exceptions [to (citations omitted).) and (B)(vi) of the Act to impose by the physician self-referral law]. In [section In the proposed rule, we stated in regulation other requirements as needed 1877(e)(2) of the Act], Congress excludes summary that, as we similarly stated in bona fide employment relationships from the to protect against program or patient the FY 2009 IPPS final rule (73 FR abuse. Nowhere in the House definition of compensation arrangements. This provision states that the employment 48716), the physician self-referral Conference Report did Congress express statute responds to the context of the an intent to limit the authority granted relationship must comply with various requirements, including that the pay not be times in which it was enacted (by to the Secretary in sections determined ‘‘in a manner that takes into addressing known risks of 1877(e)(1)(A)(vi) and (B)(vi) of the Act account (directly or indirectly) the volume or overutilization and, in particular, by (as enacted). In fact, the House value of any referrals by the referring creating exceptions for common Conference Report was completely physician.’’ This employment exception also business arrangements), and also silent regarding sections allows the Secretary to impose ‘‘other incorporates sufficient flexibility to requirements,’’ just as the equipment rental 1877(e)(1)(A)(vi) and (B)(vi) of the Act, adapt to changing circumstances and leaving the express words of the statute exception. But the statute then goes on to say that the listed requirements ‘‘shall not developments in the health care to speak for themselves. As the Court industry. For example, in section noted— prohibit the payment of remuneration in the form of a productivity bonus based on 1877(b)(4) of the Act, Congress The conference report . . . states only that services performed personally by the authorized the Secretary to protect rental charges ‘‘may’’ be based on units of physician.’’ This language shows that additional beneficial arrangements by service. The language is not obligatory. Congress knew how to cabin the Secretary’s promulgating new regulatory Instead, it simply indicates that, as written, authority to impose ‘‘other’’ requirements exceptions. In addition, Congress the rental-charge clause [(section and that it knew how to further clarify what included the means to address evolving 1877(e)(1)(B)(iv) of the Act)] does not it meant by compensation that does not take preclude per-click leases. But, as we have into account the volume of business fraud risks by inserting into many of the already explained, there is more to the statute generated between parties. That Congress exceptions—and notably, for our than this clause, and to qualify for the employed neither of these tools with purposes, in the lease exceptions— exception, a rental agreement must comply reference to the [exception for the rental of specific authority for the Secretary to with all six clauses, not merely the rental- office space or equipment] again supports add conditions as needed to protect charge clause alone. The final clause reading the statute as giving the Secretary against abuse. This design reflects a [(section 1877(e)(1)(B)(vi) of the Act)] gives broad discretion as she regulates in this area. recognition that a fraud and abuse law the Secretary the authority to add further (790 F.3d at 221 (citations omitted).) requirements. Nothing in the legislative with sweeping coverage over most of the history suggests a limit on this authority. We The Secretary’s authority to limit the health care industry could not achieve conclude that the statute does not use of per-unit of service rental charges its purpose over the long term if it were unambiguously forbid the Secretary from in arrangements for the rental of office frozen in time. In short, the statute banning per-click leases as she evaluates the space or equipment is particularly clear evidences Congress’ foresight in needs of the Medicare system and its when the exceptions for the rental of anticipating that the nature of fraud and patients. (790 F.3d at 221–22 (footnote office space and equipment are abuse—and of beneficial industry omitted).) compared to other provisions in section arrangements—might change over time. Moreover, as the Court further noted, 1877 of the Act. According to the Court (73 FR 48716 (citations omitted).) a statement that unit of service-based in Council for Urological Interests— As we did in 2007 when we first rental charges are not precluded by [T]he statute elsewhere expressly permits proposed to impose additional sections 1877(e)(1)(A)(iv) and (B)(iv) of charging per-click fees in other contexts, requirements for rental charges in the Act as they are written is not showing that Congress knew how to arrangements for the rental of office equivalent to a statement that the authorize such payment terms when it space and equipment, and in 2008 when Secretary must continue to permit such wanted to. In [section 1877(e)(7)(A) of the we finalized regulations incorporating

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such additional requirements, we relied equipment lease arrangements provided revenue raised, earned, billed, collected, in making our proposal on the compelling information regarding or otherwise attributable to the services Secretary’s clear authority in sections potential program or patient abuse. We provided while using the timeshare; or 1877(e)(1)(A)(vi) and (B)(vi) of the Act were persuaded in 2008 to finalize (2) per-unit of service fees, to the extent to impose such other requirements requirements limiting per-unit of service that such fees reflect services provided needed to protect against program or rental charges in the exceptions to patients referred by the party granting patient abuse. With respect to our applicable to the rental of office space permission to use the timeshare to the proposal to include the same or equipment, and stated our continued party to which the permission is requirements at § 411.357(l) and (p), we belief that these requirements continue granted. We explained our belief that determined that the revisions to to be necessary, due to our concerns that timeshare arrangements based on § 411.357(l) and (p) are necessary to ‘‘per-click’’ lease arrangements in which percentage compensation or per-unit of meet the standard set forth in section the lessor makes referrals to the lessee service compensation formulas present 1877(b)(4) of the Act, which authorizes that generate payments to the lessor— a risk of program or patient abuse the Secretary to establish exceptions to • Create an incentive for because they may incentivize the statute’s referral and billing overutilization of imaging services (as overutilization and patient steering. We prohibitions only where the excepted described by MedPAC in its comments noted in the CY 2016 PFS final rule, by financial relationships do not pose a to our proposal in the CY 2008 PFS way of example, that a per-patient risk of program or patient abuse. proposed rule), as well as other services, compensation formula could incent the including therapeutic services; timeshare grantor to refer patients (2) Rationale for Proposal • Create an incentive for physicians (potentially for unnecessary As we discussed in prior rulemakings, to narrow their choice of treatment consultations or services) to the party including the 1998 proposed rule, we options to those for which they will using the timeshare because the grantor stated in the proposed rule that a realize a profit, even where the best will receive a payment each time the number of studies prior to the course of action may be no treatment; premises, equipment, personnel, items, enactment of the physician self-referral • Influence physicians to refer to the supplies, or services are used (80 FR law found that physicians who had lessee instead of referring to another 71331 through 71332). Similarly, we financial relationships with entities to entity that utilizes the same or different believe that arrangements utilizing which they referred patients ordered (and perhaps more efficacious) rental charges for the rental of office more services than physicians without technology to treat the patient’s space or equipment that are determined such financial relationships (63 FR condition; using a formula that rewards the lessor • 1661). We noted that studies conducted Result in physicians steering for each service the lessor refers to the since that time, including recent studies patients to equipment they own, even if lessee are susceptible to this and other by GAO, indicate that financial self- it means having the patient travel to a abuse. interest continues to affect physicians’ non-convenient site for services using Finally, we noted in the CY 2017 PFS medical decision making. the leased equipment; and proposed rule that we are not alone in • In the FY 2009 IPPS final rule, we Increase costs to the Medicare our concern regarding overutilization discussed in detail our rationale for program when referring physicians and steering of beneficiaries resulting finalizing the limitation on per-unit of pressure hospitals to use their leasing from arrangements in which a service rental charges in arrangements company despite not being the low cost physician’s referral may provide future for the rental of office space or provider. remuneration back to the physician. In equipment. We noted primary concerns We noted that, in the CY 2016 PFS two notable advisory opinions, OIG regarding the potential for final rule, we expressed our continued expressed its concern with per-unit of overutilization, patient steering and concern that, when physicians have a service compensation arrangements. other anti-competitive effects, and financial incentive to refer a patient to Specifically, in Advisory Opinion 03– reduction in quality of care and patient a particular entity, this incentive can 08, OIG stated that ‘‘‘[p]er patient,’ ‘per outcomes, as well as concerns regarding affect utilization, patient choice, and click,’ ‘per order,’ and similar payment the potential for increased costs to the competition. Physicians can overutilize arrangements with parties in a position, Medicare program. For the reasons set by ordering items and services for directly or indirectly, to refer or forth in the FY 2009 IPPS final rule, patients that, absent a profit motive, recommend an item or service payable some of which we restated in the they would not have ordered. A by a federal health care program are proposed rule, we stated our belief that, patient’s choice is diminished when disfavored under the anti-kickback in order to protect against program or physicians steer patients to less statute. The principal concern is that patient abuse, it is necessary to impose convenient, lower quality, or more such arrangements promote additional requirements on expensive providers of health care, just overutilization . . . .’’ In Advisory arrangements for the rental of office because the physicians are sharing Opinion 10–23, OIG noted that the space or equipment. Specifically, we profits with, or receiving remuneration arrangement that was the subject of the stated that we believe that it is from, the providers. And lastly, where opinion ‘‘involves a ‘per-click’ fee necessary to prohibit rental charges that referrals are controlled by those sharing structure, which is inherently reflective are determined using a formula based profits or receiving remuneration, the of the volume or value of services on per-unit of service rental charges to medical marketplace suffers if new ordered and provided . . . .’’ the extent that such charges reflect competitors cannot win business with The following is a summary of the services provided to patients referred by superior quality, service, or price (80 FR comments we received regarding our re- the lessor to the lessee of the office 41926). We stated that, in establishing proposal. space or equipment. the exception at § 411.357(y) for Comment: The majority of In the CY 2017 PFS proposed rule, we timeshare arrangements, we determined commenters that addressed the re- noted that commenters responding to it necessary to exclude from the proposed regulations at our proposal in the CY 2008 PFS exception any timeshare arrangements § 411.357(a)(5)(ii)(B), (b)(4)(ii)(B), proposed rule to impose additional that incorporate compensation formulas (l)(3)(ii), and (p)(1)(ii)(B) supported the requirements for office space and based on: (1) A percentage of the restriction on per-unit of service (or per-

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click) compensation formulas for believe that it is necessary to prohibit commenter asserted that we lacked the determining the rental charges for office rental charges that are determined using authority to re-propose the regulations space and equipment lease a formula based on per-unit of service because our determination to prohibit arrangements. Many of these rental charges to the extent that such certain per-click rental charges cannot commenters offered general support, charges reflect services provided to be reconciled with the House while others noted appreciation for our patients referred by the lessor to the Conference Report. The commenter continued monitoring of financial lessee of the office space or equipment. asserted that we did ‘‘not even try to relationships in the health care Therefore, using our using our authority reconcile a ban on per-click industry, particularly with respect to at section 1877(e)(1)(A)(vi) and (B)(vi) of [compensation formulas] with the per-click compensation arrangements the Act, we are finalizing without [House] Conference Report.’’ At the and the ‘‘misuses of physician-owned modification the regulations re- same time, the commenter asserted that office space.’’ One commenter proposed at § 411.357(a)(5)(ii)(B), the Court rejected our explanation that, commended us for continuing to (b)(4)(ii)(B), (l)(3)(ii), and (p)(1)(ii)(B). given the authority granted to the recognize the ‘‘perverse incentives Comment: One commenter welcomed Secretary under sections created by compensation arrangements what it referred to as a ‘‘clarification’’ 1877(e)(1)(A)(vi) and (B)(vi) of the Act, between physicians and other providers that the restriction on per-unit of service the House Conference Report does not that are based on volume.’’ Another compensation formulas applies only in constrain her authority to impose commenter specifically agreed that instances where the referral that results requirements regarding the type of overutilization and abuse can occur in the payment for the use of the compensation formulas upon which under these types of arrangements and equipment comes from the lessor. office space and equipment rental agreed with our re-proposal to limit Response: The regulations at charges may be based. them. § 411.357(a)(5)(ii)(B), (b)(4)(ii)(B), Second, the commenter rejected our One commenter commended us for (l)(3)(ii), and (p)(1)(ii)(B) prohibit per- justification for re-proposing the keeping the integrity of the Medicare unit of service rental charges only to the prohibition on certain per-click program in mind by re-proposing the extent that such charges reflect services compensation formulas for determining per-click restrictions. This commenter provided to patients referred by the rental charges in arrangements for the and another noted that improper lessor to the lessee. We discussed this rental of office space and equipment. financial relationships risk wasting limitation in the FY 2009 IPPS final Specifically, the commenter claimed funds and could limit access to more rule, stating that the regulations do not that we cited no ‘‘industry appropriate treatment options. A third prohibit per-click rental payments to developments’’ since the enactment of commenter encouraged us to ‘‘keep in physician lessors for services rendered the physician self-referral law or since place the relevant restriction on per-unit to patients who were not referred to the our Phase I regulations that ‘‘now arrangements when payments are made lessee by the physician lessors, because warrant a prohibition on per-click to referral sources.’’ Another commenter such arrangements do not carry with [rental charge formulas]’’; criticized our acknowledged that a careful balance them risk under the physician self- reliance on ‘‘concerns’’ and ‘‘belief[s]’’ must be established between permitting referral statute (73 FR 48719). We again informing our judgment that per-click physicians to lease office space or discussed the provision in the CY 2017 rental charge arrangements create equipment to ensure access to patient PFS proposed rule, stating that per-unit incentives for abuse and overutilization; care and avoiding potential risks of of service rental charges for the rental of and asserted that ‘‘only empirical data abuse of the Medicare program, and office space or equipment are or evidence’’ can support a Secretarial stated its appreciation that the permissible, but only in those instances determination under the physician self- restrictions we proposed on the formula where the referral for the service to be referral law that additional conditions for rental charges are reasonable and provided in the rented office space or are needed to protect against program or preserve the ability of physicians to using the rented equipment does not patient abuse. The commenter lease office space and equipment from come from the lessor (81 FR 46450). The acknowledged that the GAO studies and other physicians. re-proposed language at other studies, as well as an OIG advisory Response: We continue to believe, § 411.357(a)(5)(ii)(B), (b)(4)(ii)(B), opinion, referenced in the CY 2017 PFS and agree with the commenters, that (l)(3)(ii), and (p)(1)(ii)(B) is identical to proposed rule ‘‘stand . . . for the arrangements for the rental of office the regulatory provisions finalized in general proposition that physician space or equipment utilizing rental the FY 2009 IPPS final rule. financial interests can affect the charges that are determined using a Comment: We received one comment utilization of medical tests and formula that rewards the lessor for each opposing our proposal to prohibit per- procedures.’’ Nonetheless, the service the lessor refers to the lessee are unit of service (‘‘per-click’’) rental commenter asserted that the re- susceptible to abuse. As discussed in charges where the lessor generates the proposed regulations must be based on the CY 2017 PFS proposed rule, such payment from the lessee through a ‘‘recent’’ developments or ‘‘recent’’ abuse includes the potential for referral to the lessee for a service to be studies showing abuse in per-click lease overutilization, patient steering and provided in the rented office space or arrangements in order to stand. stifling patient choice, and the using the rented equipment. The Response: We disagree with the reduction in quality of care and patient commenter asserted that, in its opinion, commenter. The Secretary’s authority outcomes, as well as the potential for our re-proposal of the limitation on per- for the regulations re-proposed (and increased costs to the Medicare program click rental charges does not comply finalized here) at § 411.357(a)(5)(ii)(B), (81 FR 46452). For the reasons with the Court’s decision in Council for (b)(4)(ii)(B), (l)(3)(ii), and (p)(1)(ii)(B), explained in detail in the proposed rule Urological Interests v. Burwell. The which include a requirement that the and elsewhere in this final rule, we commenter asserted that, as a result, our rental charges for the lease of office believe that, in order to protect against re-proposal of the limitation on per- space or equipment are not determined program or patient abuse, it is necessary click rental charges is arbitrary and using a formula based on per-unit of to impose additional requirements on capricious. service rental charges, to the extent that arrangements for the rental of office The commenter premised its objection such charges reflect services provided to space or equipment. Specifically, we to our proposal in two ways. First, the patients referred by the lessor to the

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lessee, is found in sections by the House Conference Report should The Secretary’s authority to impose 1877(e)(1)(A)(vi) and (B)(vi) of the Act, be disregarded on the theory that the requirements regarding the type of which we detail below. The Court in Court rejected this explanation in compensation formulas upon which Council for Urological Interests v. Council for Urological Interests. As office space and equipment rental Burwell expressly confirmed this noted above, the Court did not reject charges may be based is not constrained authority. See 790 F.3d at 219–22. We this argument; rather, the Court set out by the House Conference Report. Clause specifically disagree with—and address in detail why the Secretary’s authority (iv) in each of the statutory exceptions below—the commenter’s assertions that to impose such regulatory restrictions is for the rental of office space and we lack the authority for this not constrained by the House equipment (sections 1877(e)(1)(A) and rulemaking because: (1) Our regulations Conference Report. (Id. at 222.) In the (B) of the Act) provide that a physician cannot be reconciled with the House CY 2017 PFS proposed rule (81 FR may only make use of either exception Conference Report; and (2) only recent 46452) and again in this final rule, we if the rental charges over the term of the empirical data or evidence can support have complied with the Court’s lease are set in advance, are consistent a Secretarial determination under the directive and set forth our analysis why with fair market value, and are not physician self-referral law that a per-click ban on office space and determined in a manner that takes into additional conditions in the exceptions equipment leases is consistent with the account the volume or value of any for the rental of office space and House Conference Report. referrals or other business generated equipment are needed to protect against In accordance with the Court’s between the parties. In the 1998 program or patient abuse. opinion in Council for Urological proposed rule, we proposed to interpret We first address the commenter’s Interests and in support of this final the ‘‘volume or value’’ standard, which assertion that a ban on per-click rental rule, we set forth below the Secretary’s is common in many of the exceptions to charges in arrangements for the lease of authority to include in the exceptions the physician self-referral law and office space or equipment cannot be applicable to office space and included in the exceptions for the rental reconciled with the House Conference equipment leases a requirement that of office space and equipment at Report. The commenter is incorrect. In rental charges are not determined using sections 1877(e)(1)(A)(iv) and (B)(iv) of Council for Urological Interests, the a formula based on per-unit of service the Act, respectively, as permitting only Court itself explicitly reconciled such a rental charges that reflect services those per-click compensation formulas ban with respect to per-click equipment provided to patients referred by the where the units of service did not leases, stating that the legislative history lessor to the lessee. Our determination include services provided to patients ‘‘simply indicates that, as written, the follows the Court’s reasoning, which we who were referred by the physician rental-charge clause [in section excerpt below, in rejecting the Council receiving the payment (63 FR 1714). In 1877(e)(1)(B)(iv) of the Act] does not for Urological Interests’ assertion that our Phase I interim final rule with preclude per-click leases’’ and the Secretary lacks the authority to comment period, we stated that, after emphasized that ‘‘[n]othing in the impose a ban on certain ‘‘per-click’’ reviewing the comments on our legislative history suggests a limit on equipment—and by correlation—office proposed interpretation of the ‘‘volume [the Secretary’s] authority’’ to prohibit space leases. We also further describe or value’’ standard, we were per-click leases under section why limiting the types of per-click substantially revising the regulation 1877(e)(1)(B)(vi) of the Act (790 F.3d at rental charges that would not violate the with respect to the scope of that 222.). Here, in finalizing the re-proposed physician self-referral law’s referral and standard (66 FR 876). Most importantly, regulations at § 411.357(a)(5)(ii)(B) and claims submission prohibitions is under our revised interpretation of the (b)(4)(ii)(B), we are relying on the consistent with the language of the ‘‘volume or value’’ standard, we would Secretary’s authority under sections House Conference Report. permit time-based or unit-based 1877(e)(1)(A)(vi) and (B)(vi) of the Act As the Court stated, the physician compensation formulas, even when the to impose such other requirements self-referral law gives the Secretary physician receiving the rental payment needed to protect against program or power to add requirements as needed to generated the payment through a DHS patient abuse. Thus, the House protect against program or patient referral. We noted that we reviewed the Conference Report can be reconciled abuse, even if Congress did not legislative history with respect to the with a ban on per-click rental charges in anticipate such abuses at the time of exceptions for office space and arrangements for the lease of office enactment of the statute. Specifically, equipment lease arrangements and space or equipment. although Congress may not have concluded that Congress intended that We next address the commenter’s originally included a ban on per-click sections 1877(e)(1)(A)(iv) and (B)(iv) of assertion that our CY 2017 PFS rental charges in office space and the Act not be interpreted to prohibit rulemaking ‘‘did not even try to equipment lease arrangements, it time-based or unit-of-service-based reconcile a ban on per-click ‘‘empowered the Secretary to make her compensation formulas, so long as the [compensation formulas] with the own assessment of the needs of the payment per unit is fair market value at [House] Conference Report.’’ The Medicare program and regulate inception and does not subsequently Court’s directive to the Secretary was to accordingly.’’ (Council for Urological change during the lease term in any ‘‘consider—with more care than she Interests, 790 F.3d at 220.) The statute manner that takes into account DHS exercised [in the FY 2009 IPPS final explicitly permits the Secretary to referrals. rule]—whether a per-click ban on impose additional conditions on The passage in the House Conference equipment leases is consistent with the arrangements for the rental of office Report relevant to sections 1993 Conference Report.’’ (Id. at 224.) space or equipment, and nowhere 1877(e)(1)(A)(iv) and (B)(iv) of the Act The commenter implied that our expressly states that per-click rates must reads in full— explanation in the proposed rule as to always be permitted. As the Court why the Secretary’s authority to impose confirmed, the Secretary’s regulation The conferees intend that charges for space and equipment leases may be based on daily, requirements regarding the type of ‘‘can properly be classified as an ‘other’ monthly, or other time-based rates, or rates compensation formulas upon which requirement expressly permitted by based on units of service furnished, so long office space and equipment rental sections 1877(e)(1)(A)(vi) and (B)(vi) of as the amount of the time-based or units of charges may be based is not constrained the Act.’’ (Id.) service rates does not fluctuate during the

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contract period based on the volume or value Moreover, as the Court further noted, 1877 of the Act. According to the Court of referrals between the parties to the lease a statement that unit of service-based in Council for Urological Interests— agreement. (H.R. Rep. No. 103–213, at 814 rental charges are not precluded by (1993)). [T]he statute elsewhere expressly permits sections 1877(e)(1)(A)(iv) and (B)(iv) of charging per-click fees in other contexts, In the CY 2017 PFS proposed rule, we the Act as they are written is not showing that Congress knew how to again acknowledged that the language in equivalent to a statement that the authorize such payment terms when it Secretary must continue to permit such wanted to. In [section 1877(e)(7)(A) of the the House Conference Report states Act], Congress created an exception to the Congress’ intent at the time of charges as she reevaluates, in light of experience, the operation of the statute [physician self-referral law] that allows the enactment of the physician self-referral continuation of certain group practice law that sections 1877(e)(1)(A)(iv) and and the need to protect the Medicare arrangements with a hospital. . . . The (B)(iv) of the Act (the clauses that program and its beneficiaries against provision states that ‘‘[a]n arrangement contain the ‘‘volume or value’’ standard abuse. (Id. at 222 n.7; see also id. at 222 between a hospital and a group under which in the exceptions for the rental of office n.6 (‘‘Congress has expressly delegated designated health services are provided by space and equipment, respectively) not to the Secretary the authority to the group but are billed by the hospital’’ is excepted from the ban on referrals if, among be interpreted as prohibiting charges for promulgate additional requirements, as she has done here, and the legislative other things, ‘‘the compensation paid over the rental of office space or equipment the term of the agreement is consistent with that are based on units of service history does not clearly impose a constraint on that power.’’).) fair market value and the compensation per furnished (81 FR 46451). Even so, the unit of services is fixed in advance and is not House Conference Report in no way The Secretary has broad authority determined in a manner that takes into limits any other provision, including under sections 1877(e)(1)(A)(vi) and account the volume or value of any referrals clause (vi) of the exceptions for the (B)(vi) of the Act to impose conditions or other business generated between the rental of office space and equipment. on arrangements for the rental of office parties.’’ Comparing this provision to the [exceptions for the rental of office space and As in the proposed rule, we do not space or equipment in order to protect against program or patient abuse. That equipment] shows that Congress knew how purport here to interpret this language to permit per-click payments explicitly, as implying anything other than the authority is not limited by the express suggesting that the omission in this particular conferees’ understanding—at the time of words of the statute as it is in other context was deliberate. . . . In other words, enactment of the statute—that the provisions of section 1877 of the Act. In Congress’s decision not to include similar statute as written did not prohibit rental agreement, the Court in Council for language in the [exceptions for the rental of charges based on unit-of-service rates. Urological Interests explained— office space and equipment] supports our conclusion that the statute is silent regarding . . . Congress knew how to limit the But Congress also gave the Secretary the the permissibility of per-click leases for Secretary’s authority to impose additional authority in sections 1877(e)(1)(A)(vi) equipment rentals. (790 F.3d at 220–21 requirements to the various exceptions [to and (B)(vi) of the Act to impose by (citations omitted).) regulation other requirements as needed the physician self-referral law]. In [section In summary, as we stated in the FY to protect against program or patient 1877(e)(2) of the Act], Congress excludes bona fide employment relationships from the 2009 IPPS final rule (73 FR 48716), the abuse, which could only happen after definition of compensation arrangements. physician self-referral statute responds the enactment of the statute. Nowhere in This provision states that the employment to the context of the times in which it the House Conference Report did relationship must comply with various was enacted (by addressing known risks Congress express an intent to limit the requirements, including that the pay not be of overutilization and, in particular, by authority granted to the Secretary in determined ‘‘in a manner that takes into creating exceptions for common sections 1877(e)(1)(A)(vi) and (B)(vi) of account (directly or indirectly) the volume or business arrangements), and also the Act (as enacted). In fact, the House value of any referrals by the referring incorporates sufficient flexibility to Conference Report was completely physician.’’ This employment exception also adapt to changing circumstances and silent regarding sections allows the Secretary to impose ‘‘other developments in the health care 1877(e)(1)(A)(vi) and (B)(vi) of the Act, requirements,’’ just as the equipment rental exception. But the statute then goes on to say industry. For example, in section leaving the express words of the statute that the listed requirements ‘‘shall not 1877(b)(4) of the Act, Congress to speak for themselves. As the Court prohibit the payment of remuneration in the authorized the Secretary to protect noted— form of a productivity bonus based on additional beneficial arrangements by The conference report . . . states only that services performed personally by the promulgating new regulatory physician.’’ This language shows that rental charges ‘‘may’’ be based on units of exceptions. In addition, Congress service. The language is not obligatory. Congress knew how to cabin the Secretary’s authority to impose ‘‘other’’ requirements included the means to address other Instead, it simply indicates that, as written, fraud risks by inserting into many of the the rental-charge clause [(section and that it knew how to further clarify what 1877(e)(1)(B)(iv) of the Act)] does not it meant by compensation that does not take exceptions—and notably, for our preclude per-click leases. But, as we have into account the volume of business purposes, in the lease exceptions— already explained, there is more to the statute generated between parties. That Congress specific authority for the Secretary to than this clause, and to qualify for the employed neither of these tools with add conditions as needed to protect reference to the [exceptions for the rental of exception, a rental agreement must comply against abuse. This design reflects a office space or equipment] again supports with all six clauses, not merely the rental- recognition that a fraud and abuse law reading the statute as giving the Secretary charge clause alone. The final clause broad discretion as she regulates in this area. with sweeping coverage over most of the [(section 1877(e)(1)(B)(vi) of the Act)] gives (790 F.3d at 221 (citations omitted).) health care industry could not achieve the Secretary the authority to add further its purpose over the long term if it were requirements. Nothing in the legislative The Secretary’s authority to limit the frozen in time (73 FR 48716). It also history suggests a limit on this authority. We use of per-unit of service rental charges demonstrates Congress’ respect for conclude that the statute does not unambiguously forbid the Secretary from in arrangements for the rental of office regulatory expertise of the Secretary. banning per-click leases as she evaluates the space or equipment is particularly clear The Secretary administers and oversees needs of the Medicare system and its when the exceptions for the rental of numerous federal health care programs, patients. (790 F.3d at 221–22 (footnote office space and equipment are including Medicare and Medicaid, and omitted).) compared to other provisions in section interacts with numerous participants in

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the health care industry. Aware of the rule here, we rely exclusively on the number of studies prior to the Secretary’s expertise in this area, Secretary’s authority under sections enactment of the physician self-referral Congress expressly allowed the 1877(e)(1)(A)(vi) and (B)(vi) of the Act law found that physicians who had Secretary to impose further restrictions to impose such other requirements as financial relationships with entities to upon compensation arrangements that needed to protect against program or which they referred patients ordered the Secretary, in her judgment, finds to patient abuse. We do not rely on the more services than physicians without present risks of overutilization and interpretation that the Court in Council such financial relationships (63 FR abuse. (Accord, e.g., Council for for Urological Interests found to be 1661). Studies conducted since that Urological Interests, 790 F.3d at 220 arbitrary and capricious, and we note time, including recent studies by GAO, (‘‘While Congress may not have that the House Conference Report does indicate that financial self-interest originally intended the ban of per-click not present any ‘‘interpretive continues to affect physicians’ medical leases, it empowered the Secretary to roadblock’’ to invoking our authority decision making. We note that the make her own assessment of the needs under sections 1877(e)(1)(A)(vi) and commenter agreed that, as a general of the Medicare program and regulate (B)(vi) of the Act. matter, ‘‘physician financial interests accordingly.’’).) We next address the commenter’s can affect the utilization of medical tests As we did in 2007 when we first assertion that only recent empirical data and procedures.’’ Nonetheless, the proposed to impose additional or evidence can support a Secretarial regulations finalized in this rulemaking requirements for rental charges in determination under the physician self- at § 411.357(a)(5)(ii)(B), (b)(4)(ii)(B), arrangements for the rental of office referral law that additional conditions (l)(3)(ii), and (p)(1)(ii)(B) are based not space and equipment, and in 2008 when in the exceptions for the rental of office merely on general propositions we finalized regulations incorporating space and equipment are needed to regarding financial self-interest, but on such additional requirements, we are protect against program or patient input from stakeholders and public relying in this final rule on the abuse, and that the agency may not rely comments to proposed rulemaking, as Secretary’s clear authority in sections on its concerns and beliefs when issuing well as our own conclusions and those 1877(e)(1)(A)(vi) and (B)(vi) of the Act regulations. As a preliminary matter, of our law enforcement partners to finalize such other requirements section 1877 of the Act does not require regarding the risks of per-click needed to protect against program or the agency to ‘‘clear a specific compensation arrangements. Contrary to patient abuse. With respect to our evidentiary hurdle prior to imposing the commenter’s contention that we determination to include the same additional restrictions for lease cited ‘‘no industry developments since requirements at §§ 411.357(l) and (p), exceptions.’’ (Council for Urological the [physician self-referral] law was we have determined that the revisions Interests v. Sebelius, 946 F. Supp. 2d 91, enacted—or since the 2001 [Phase I] to §§ 411.357(l) and (p) that we are 110 n.15 (D.D.C. 2013), aff’d in part, regulations,’’ we stated in the CY 2017 finalizing here are necessary to meet the rev’d in part sub nom. Council of PFS proposed rule and repeat here that standard set forth in section 1877(b)(4) Urological Interests v. Burwell, 790 F.3d commenters responding to our proposal of the Act, which authorizes the 212 (D.C. Cir. 2015)). Specifically, the in the CY 2008 PFS proposed rule to Secretary to establish exceptions to the provisions upon which we rely for impose additional requirements for statute’s referral and billing prohibitions finalizing the re-proposed regulations, office space and equipment lease only where the excepted financial sections 1877(e)(1)(A)(vi) and (B)(vi) of arrangements provided compelling relationships do not pose a risk of the Act, impose no such precondition information regarding potential program program or patient abuse. on the Secretary’s ability to regulate, or patient abuse. In addition, We intend and believe that the and it is reasonable to infer that ‘‘[i]f commenters responding to our proposal reasoning set forth in this final rule fully Congress had wanted the Secretary to in the CY 2017 PFS proposed rule addresses the basis for the D.C. Circuit’s meet a specific evidentiary burden of supported the continuation of the per- conclusion that the prior regulation of proof, it would have said so.’’ Id. click bans finalized in the FY 2009 IPPS per-click compensation arrangements Moreover, the Administrative Procedure final rule. We note that, even in the contained in the FY 2009 IPPS final rule Act itself does not impose any ‘‘general absence of the information upon which was arbitrary and capricious. In Council obligation on agencies to produce we relied in the FY 2009 IPPS final rule for Urological Interests, the Court empirical evidence.’’ (Stilwell v. Office and in this final rule (all of which was remanded the rule because it disagreed of Thrift Supervision, 569 F.3d 514, 519 with our statement in the FY 2009 IPPS (D.C. Cir. 2009).) An agency’s reasoned developed after the publication of the final rule that ‘‘both the statutory assessment of the potential for abuse Phase I interim final rule with comment language [of section 1877(e)(1)(A)(iv) inherent in a particular business period), the commenter is incorrect that and (B)(iv)] and the Conference Report’’ arrangement—particularly in we are now prohibited from could ‘‘reasonably be interpreted to circumstances where, as here, that determining that additional conditions exclude’’ the relevant per-click assessment is corroborated by numerous on certain per-click compensation payments even without reliance on the comments in the rulemaking—justifies formulas are needed to protect against Secretary’s separate authority under the issuance of a prophylactic rule. program or patient abuse. It is axiomatic sections 1877(e)(1)(A)(vi) and (B)(vi) of (Stilwell, 569 F.3d at 519 (‘‘[A]gencies that ‘‘agencies are entitled to alter their the Act (73 FR 48716). The Court can, of course, adopt prophylactic rules policies ‘with or without a change in concluded that this statement to prevent potential problems before circumstances,’ so long as they undermined the reasonableness of the they arise. An agency need not suffer satisfactorily explain why they have regulation as a whole because the the flood before building the levee.’’); done so.’’ (Nat’l Audubon Soc’y v. agency had ‘‘treate[d] the Conference see also Ethyl Corp. v. Envtl. Prot. Hester, 801 F.2d 405, 408 (D.C. Cir. Report as a key interpretive roadblock,’’ Agency, 541 F.2d 1, 25 (D.C. Cir. 1976) 1986) (per curiam) (quoting State Farm, and thus may have relied on an (‘‘Awaiting certainty will often allow for 463 U.S. at 57).) erroneous interpretation as a basis for only reactive, not preventive, In the FY 2009 IPPS final rule and the the regulation. (Council for Urological regulation.’’).) CY 2017 PFS proposed rule, we Interests, 790 F.3d at 224.) By contrast, As we discussed in prior rulemakings, discussed in detail our rationale for the in re-proposing and now finalizing this including the 1998 proposed rule, a limitation on per-unit of service rental

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charges in arrangements for the rental of restated below, we continue to believe referrals are controlled by those sharing office space or equipment. We that, in order to protect against program profits or receiving remuneration, the explained that under a per-unit of or patient abuse, it is necessary to medical marketplace suffers if new service rental arrangement, the more impose additional requirements on competitors cannot win business with referrals that a physician lessor makes, arrangements for the rental of office superior quality, service, or price (80 FR the more revenue he or she earns. (73 space or equipment. Specifically, we 41926). In that rule, in establishing the FR 48715 and 48718; 81 FR 46452– believe that it is necessary to prohibit exception at § 411.357(y) for timeshare 46453). We noted primary concerns rental charges that are determined using arrangements, we determined it regarding the potential for a formula based on per-unit of service necessary to exclude from the exception overutilization, patient steering, and rental charges to the extent that such any timeshare arrangements that reduction in quality of care and patient charges reflect services provided to incorporate compensation formulas outcomes, as well as concerns regarding patients referred by the lessor to the based on: (1) A percentage of the the potential for increased costs to the lessee of the office space or equipment. revenue raised, earned, billed, collected, Medicare program. In summarizing the We were persuaded to finalize in the or otherwise attributable to the services comments to our proposals in the CY FY 2009 IPPS final rule requirements provided while using the timeshare; or 2008 PFS proposed rule and explaining limiting per-unit of service rental (2) per-unit of service fees, to the extent our rationale for finalizing those charges in the exceptions applicable to that such fees reflect services provided proposals, we stated in the FY 2009 the rental of office space or equipment, to patients referred by the party granting IPPS final rule that numerous and agree with the commenters to the permission to use the timeshare to the commenters—including physicians, CY 2017 PFS proposed rule that these party to which the permission is physician groups, and others— requirements continue to be necessary, granted. We explained our belief that specifically agreed that these risks were due to our concerns that ‘‘per-click’’ timeshare arrangements based on raised by per-click leasing lease arrangements in which the lessor percentage compensation or per-unit of arrangements. For example, we noted makes referrals to the lessee that service compensation formulas present generate payments to the lessor— a risk of program or patient abuse that one commenter, a radiation • oncologist, said that some leasing Create an incentive for because they may incentivize arrangements are abusive and provide overutilization of imaging services (as overutilization and patient steering. We incentives to physicians to narrow their described by MedPAC in its comments noted, by way of example, that a per- choice of treatment options to those for to our proposal in the CY 2008 PFS patient compensation formula could which they will realize a profit (73 FR proposed rule), as well as other services, incent the timeshare grantor to refer 48714). We further noted that another including therapeutic services; patients (potentially for unnecessary • Create an incentive for physicians commenter, an association of consultations or services) to the party to narrow their choice of treatment radiologists, stated that it strongly using the timeshare because the grantor options to those for which they will supports banning use-of-service based will receive a payment each time the realize a profit, even where the best leases because such leases fuel an premises, equipment, personnel, items, course of action may be no treatment; supplies, or services are used (80 FR incentive to order unnecessary • Influence physicians to refer to the examinations. (Id.) Other commenters 71331 through 71332). Similarly, we lessee instead of referring to another believe that arrangements utilizing expressed similar concerns. We also entity that utilizes the same or different emphasized in the FY 2009 IPPS final rental charges for the rental of office (and perhaps more efficacious) space or equipment that are determined rule that, even with respect to referrals technology to treat the patient’s for therapeutic (as opposed to using a formula that rewards the lessor condition; for each service the lessor refers to the diagnostic) services, the risks of • Result in physicians steering overutilization and abuse may be lessee are susceptible to this and other patients to equipment they own, even if abuse. Simply put, per-click lease substantial (73 FR 48718). Regardless of it means having the patient travel to a the use for the equipment at issue, there arrangements create an incentive for non-convenient site for services using overutilization because the physician remains the potential for a physician the leased equipment; and knows that the more referrals he or she lessor, in order to protect his or her • Increase costs to the Medicare makes to the lessee, the more revenue investment or gain additional profits, to program when referring physicians that that physician will earn. refer patients to the lessee of that pressure hospitals to use their leasing For all of these reasons, and because equipment. (Id.) As an example of company despite not being the low cost we believe that there is a continued overutilized therapeutic treatments, we provider. (See 73 FR 48715–48718). need to protect the program and its noted that a large hospital system had We note also that, in the CY 2016 PFS beneficiaries against the potential settled a case involving several of their final rule, we expressed our continued abuses of per-click office space and physicians who were accused of concern that, when physicians have a equipment leases, we are finalizing performing unnecessary cardiac financial incentive to refer a patient to without modification the re-proposed surgeries. In that case, federal officials a particular entity, this incentive can regulations at § 411.357(a)(5)(ii)(B), alleged that the physicians had entered affect utilization, patient choice, and (b)(4)(ii)(B), (l)(3)(ii), and (p)(1)(ii)(B), into a scheme to cause patients to competition. Physicians can overutilize which include a requirement that the undergo unneeded, invasive cardiac by ordering items and services for rental charges for the lease of office procedures such as artery bypass and patients that, absent a profit motive, space or equipment are not determined heart valve replacement surgeries in they would not have ordered. A using a formula based on per-unit of order to generate additional revenue. patient’s choice is diminished when service rental charges, to the extent that We noted that the hospital system physicians steer patients to less such charges reflect services provided to agreed to pay $54 million to settle the convenient, lower quality, or more patients referred by the lessor to the federal case. (Id.) expensive providers of health care, just lessee. For the reasons set forth in the FY because the physicians are sharing Comment: Although not commenting 2009 IPPS final rule and the CY 2017 profits with, or receiving remuneration specifically on our actual proposals, two PFS proposed rule, some of which are from, the providers. And lastly, where commenters suggested that we analyze

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the physician self-referral law pace with the rapidly evolving provider current language in this subsection regulations and any revisions to the landscape and efforts to integrate directs a requesting party to submit its regulations to consider the impact on medical professionals into accountable request to a physical address that is out stakeholders’ work to develop beneficial networks of integrated providers or (2) of date. In an effort to expedite the arrangements that advance health care permit hospitals to subsidize the start- receipt and processing of these requests, payment and delivery reforms. up costs needed to meet the objectives and to account for any future changes, Response: We note that the of value-based purchasing, MIPS, and we proposed to revise paragraph (a) to restrictions on per-unit of service participation in alternative payment state that a party or parties must submit compensation formulas have been in models; modify the in-office ancillary a request for an advisory opinion to place since October 1, 2009. Although services exception at § 411.355(b) to CMS according to the instructions we are cognizant of the impact of the exclude certain designated health specified on the CMS Web site. physician self-referral law on health services from the coverage of the We noted that, at the time of the care payment and delivery reform exception; revise the definition of proposed rule, the correct address for efforts, we must balance concerns about ‘‘entity’’ and our policy regarding such advisory opinion requests was: impeding such efforts against protecting services furnished ‘‘under Centers for Medicare & Medicaid the Medicare program and its arrangements’’ to an entity furnishing Services, Department of Health and beneficiaries. For the reasons stated in designated health services; revise the Human Services, Office of Financial the FY 2009 IPPS final rule, the CY 2017 requirements for ‘‘group practices’’ to Management, Division of Premium PFS proposed rule, and in this final remove the requirement at § 411.352(g) Billing and Collections, Mail Stop C3– rule, we believe these restrictions are prohibiting compensation to group 09–27, Attention: Advisory Opinions, necessary to protect the Medicare practice physicians that takes into 7500 Security Boulevard, Baltimore, MD program and its beneficiaries against account the volume or value of referrals; 21244–1850. However, we noted that abuse. and establish exceptions to or grant this address is subject to change, per Comment: Two commenters requested waivers of the physician self-referral this technical correction, and that that we confirm that FAQ 9780 law’s referral and billing prohibitions parties seeking to submit a request for regarding lithotripsy services provided similar to those for ACOs participating an advisory opinion relating to ‘‘under arrangements’’ to a hospital by in the MSSP and certain CMMI models physician referrals would need to refer a physician-owned lithotripsy vendor that would enable physicians to to the instructions on the CMS Web site. remains CMS policy despite our re- participate in alternative payment We received no comments regarding proposal of the regulations at modes and earn incentives through this technical correction and are § 411.357(a)(5)(ii)(B), (b)(4)(ii)(B), MIPS. finalizing it without modification. (l)(3)(ii), and (p)(1)(ii)(B). One of the Response: Although we appreciate the commenters indicated it would oppose commenters’ thoughtful consideration N. Physician Self-Referral Law: Annual re-proposed § 411.357(a)(5)(ii)(B), of the impact of the physician self- Update to the List of CPT/HCPCS Codes (b)(4)(ii)(B), (l)(3)(ii), and (p)(1)(ii)(B) if referral law on physicians and entities 1. General the intent of the re-proposed regulations furnishing designated health services, is to reverse the policy set forth in FAQ our proposals in the CY 2017 PFS Section 1877 of the Act prohibits a 9780. This commenter requested that, if proposed rule relate only to the per- physician from referring a Medicare we are indeed reversing the policy set click compensation formula restrictions beneficiary for certain designated health forth in FAQ 9780, we do so by at § 411.357(a)(5)(ii)(B), (b)(4)(ii)(B), services (DHS) to an entity with which proposing regulatory language and (l)(3)(ii), and (p)(1)(ii)(B) and our the physician (or a member of the offering the opportunity for public advisory opinion regulations at physician’s immediate family) has a comment. § 411.372. Therefore, the suggested financial relationship, unless an Response: The policy established in revisions are outside the scope of this exception applies. Section 1877 of the FAQ 9780 remains our policy regarding rulemaking. Act also prohibits the DHS entity from lithotripsy service arrangements After considering the comments, for submitting claims to Medicare or billing between physician-owned lithotripsy the reasons set forth above and in the the beneficiary or any other entity for vendors and hospitals. FAQ 9780 is CY 2017 proposed rule (81 FR 46448), Medicare DHS that are furnished as a available on the CMS Web site at we are finalizing without modification result of a prohibited referral. https://questions.cms.gov/ our proposal to include at Section 1877(h)(6) of the Act and faq.php?id=5005&faqId=9780 and states § 411.357(a)(5)(ii)(B), (b)(4)(ii)(B), § 411.351 of our regulations specify that that, provided that a lithotripsy vendor the following services are DHS: (l)(3)(ii), and (p)(1)(ii)(B) a requirement • is actually furnishing a service (or a that the rental charges for the lease of Clinical laboratory services. • Physical therapy services. package of services) to the hospital, and office space or equipment are not • not merely leasing equipment over Occupational therapy services. determined using a formula based on • Outpatient speech-language which the hospital would have per-unit of service rental charges, to the pathology services. dominion and control, the hospital may extent that such charges reflect services • Radiology services. compensate the lithotripsy vendor using provided to patients referred by the • Radiation therapy services and a per-unit or percentage-based lessor to the lessee. supplies. compensation formula, as long as all of • Durable medical equipment and the requirements of a relevant exception 2. Technical Correction: Advisory Opinions Relating to Physician supplies. are satisfied. • Parenteral and enteral nutrients, Comment: Many commenters Referrals, Procedure for Submitting a Request equipment, and supplies. requested that we revise our regulations • Prosthetics, orthotics, and in ways other than as re-proposed in the We proposed to revise § 411.372(a) by prosthetic devices and supplies. CY 2017 PFS proposed rule. These making a minor technical correction to • Home health services. comments suggested variously that we change the instructions for submitting a • Outpatient prescription drugs. ‘‘modernize’’ the definitions and request for an advisory opinion relating • Inpatient and outpatient hospital exceptions in the regulations to (1) keep to physician referrals. We noted that the services.

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2. Annual Update to the Code List exception at § 411.355(g), only those TABLE 45—ADDITIONS TO THE PHYSI- a. Background drugs that are required for the efficacy CIAN SELF-REFERRAL LIST OF of dialysis may be identified on the List CPT 1/ HCPCS CODES In § 411.351, we specify that the of CPT/HCPCS Codes as eligible for the entire scope of four DHS categories is exception. As we have explained Clinical Laboratory Services defined in a list of CPT/HCPCS codes previously in the CY 2010 PFS final rule 0008M Onc breast risk score (the Code List), which is updated with comment period (75 FR 73583), we annually to account for changes in the do not believe any of these drugs are Physical Therapy, Occupational Therapy, and most recent CPT and HCPCS Level II required for the efficacy of dialysis. Outpatient Speech–Language Pathology Serv- publications. The DHS categories Therefore, we have not included any ices defined and updated in this manner are: such drugs on the list of drugs that can 97161 Pt eval low complex 20 min • Clinical laboratory services. • qualify for the exception. 97162 Pt eval mod complex 30 min Physical therapy, occupational 97163 Pt eval high complex 45 min therapy, and outpatient speech-language The Code List was last updated in 97164 Pt re-eval est plan care pathology services. Tables 50 and 51 of the CY 2016 PFS 97165 Ot eval low complex 30 min • Radiology and certain other imaging final rule with comment period (80 FR 97166 Ot eval mod complex 45 min 97167 Ot eval high complex 60 min services. 71342). 97168 Ot re-eval est plan care • Radiation therapy services and supplies. b. Response to Comments Radiology and Certain Other Imaging Services The Code List also identifies those We received one public comment 0422T Tactile breast img uni/bi items and services that may qualify for relating to the Code List that became 76706 Us abdl aorta screen aaa either of the following two exceptions to 77065 Dx mammo incl cad uni effective January 1, 2016. the physician self-referral prohibition: 77066 Dx mammo incl cad bi • Comment: One commenter asked that 77067 Scr mammo bi incl cad EPO and other dialysis-related A9515 Choline c–11 drugs furnished in or by an ESRD the screening breast tomosynthesis code A9587 Gallium Ga–68 facility (§ 411.355(g)). 77063 be added to the list of A9588 Fluciclovine F–18 • Preventive screening tests, ‘‘Preventive Screening Tests, A9597 Pet, dx, for tumor id, noc immunizations, or vaccines A9598 Pet dx for non-tumor id, noc Immunizations and Vaccines’’ to which C9461 Choline C 11, diagnostic (§ 411.355(h)). the physician self-referral law does not C9744 Abd us w/contrast The definition of DHS at § 411.351 apply. The commenter indicated that Q9982 Flutemetamol f18 diagnostic excludes services for which payment is adding this code is necessary to conform Q9983 Florbetaben f18 diagnostic made by Medicare as part of a with various CMS policy statements and Radiation Therapy Services and Supplies composite rate (unless the services are noted that the other screening specifically identified as DHS and are mammography services codes payable {No additions} themselves payable through a composite by Medicare are on this list. Drugs Used by Patients Undergoing Dialysis rate, such as home health and inpatient Response: We agree and have added and outpatient hospital services). {No additions} code 77063 to the list of ‘‘Preventive Effective January 1, 2011, EPO and Screening Tests, Immunizations and Preventive Screening Tests, Immunizations and dialysis-related drugs furnished in or by Vaccines an ESRD facility (except drugs for which Vaccines’’ to which the physician self- there are no injectable equivalents or referral law does not apply. 77063 Breast tomosynthesis bi 77067 Scr mammo bi incl cad other forms of administration), have c. Revisions Effective for CY 2017 90674 CCIIV4 vac no prsv 0.5 ml im been reimbursed under a composite rate 90687 IIV4 vacc splt 0.25 ml im known as the ESRD prospective The updated, comprehensive Code G0499 HepB screen high risk indiv List effective January 1, 2017, is payment system (ESRD PPS) (75 FR 1 CPT codes and descriptions only are copy- 49030). Accordingly, EPO and any available on our Web site at http:// right 2016 AMA. All rights are reserved and ap- dialysis-related drugs that are paid for www.cms.gov/Medicare/Fraud-and- plicable FARS/DFARS clauses apply. under ESRD PPS are not DHS and are Abuse/PhysicianSelfReferral/List_of_ not listed among the drugs that could Codes.html. TABLE 46—DELETIONS FROM THE qualify for the exception at § 411.355(g) Additions and deletions to the Code PHYSICIAN SELF-REFERRAL LIST OF for EPO and other dialysis-related drugs List conform it to the most recent CPT 1/ HCPCS CODES furnished by an ESRD facility. publications of CPT and HCPCS Level II Drugs for which there are no and to changes in Medicare coverage Clinical Laboratory Services injectable equivalents or other forms of policy and payment status. { } administration were scheduled to be No deletions paid under ESRD PPS beginning January Tables 45 and 46 identify the Physical Therapy, Occupational Therapy, and 1, 2014 (75 FR 49044). However, there additions and deletions, respectively, to Outpatient Speech–Language Pathology Serv- have been several delays of the the comprehensive Code List that ices become effective January 1, 2017. Tables implementation of payment of these 97001 Pt evaluation drugs under ESRD PPS. Most recently, 45 and 46 also identify the additions 97002 Pt re-evaluation on December 19, 2014, section 204 of and deletions to the list of codes used 97003 Ot evaluation the Achieving a Better Life Experience to identify the items and services that 97004 Ot re-evaluation Act of 2014 (ABLE) (Pub. L. 113–295) may qualify for the exception in Radiology and Certain Other Imaging Services was enacted and delayed the inclusion § 411.355(g) (regarding dialysis-related of these drugs under the ESRD PPS until outpatient prescription drugs furnished 77051 Computer dx mammogram add-on 77052 Comp screen mammogram add-on 2025. Until that time, such drugs in or by an ESRD facility) and in 77055 Mammogram one breast furnished in or by an ESRD facility are § 411.355(h) (regarding preventive 77056 Mammogram both breasts not paid as part of a composite rate and screening tests, immunizations, and 77057 Mammogram screening thus, are DHS. For purposes of the vaccines). A9544 I131 tositumomab, dx

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TABLE 46—DELETIONS FROM THE IV. Collection of Information • Our effort to minimize the PHYSICIAN SELF-REFERRAL LIST OF Requirements information collection burden on the CPT 1/ HCPCS CODES—Continued Under the Paperwork Reduction Act affected public, including the use of of 1995 (PRA) (44 U.S.C. Chapter 35), automated collection techniques. C9458 Florbetaben f18 In the CY 2017 PFS proposed rule (81 C9459 Flutemetamol f18 we are required to publish a 30-day notice in the Federal Register and FR 46456–46457) we solicited public Radiation Therapy Services and Supplies solicit public comment before a comment on each of the section collection of information requirement is 3506(c)(2)(A)-required issues for the 0019T Extracorp shock wv tx ms nos following information collection A9545 I131 tositumomab, rx submitted to the Office of Management and Budget (OMB) for review and requirements. PRA-related comments Drugs Used by Patients Undergoing Dialysis approval. were received as indicated below under To fairly evaluate whether an section IV.B.2. {No deletions} information collection should be A. Wage Estimates Preventive Screening Tests, Immunizations and approved by OMB, section 3506(c)(2)(A) Vaccines of the PRA requires that we solicit To derive average costs, we used data comment on the following issues: from the U.S. Bureau of Labor Statistics’ 77052 Comp screen mammogram add-on • The need for the information May 2015 National Occupational 77057 Mammogram screening collection and its usefulness in carrying Employment and Wage Estimates for all 1 CPT codes and descriptions only are copy- out the proper functions of our agency. salary estimates. In this regard, Table 47 right 2016 AMA. All rights are reserved and ap- • The accuracy of our burden presents the mean hourly wage, the cost plicable FARS/DFARS clauses apply. estimates. of fringe benefits (calculated at 100 • The quality, utility, and clarity of percent of salary), and the adjusted the information to be collected. hourly wage.

TABLE 47—NATIONAL OCCUPATIONAL EMPLOYMENT AND WAGE ESTIMATES

Mean hourly Adjusted Occupation title Occupation wage Fringe benefit hourly wage code ($/hr) ($/hr) ($/hr)

Compliance Officer ...... 13–1041 33.26 33.26 66.52 Epidemiologist ...... 19–1040 36.97 36.97 73.94 Medical Scientist ...... 19–1042 45.06 45.06 90.12 Medical Secretary ...... 43–6013 16.50 16.50 33.00 Non-Physician Practitioner (Health Diagnosing and Treating Practitioners) ... 29–1000 46.65 46.65 93.90 Office and Administrative Support Operations ...... 43–0000 17.47 17.47 34.94 Physicians and Surgeons ...... 29–1060 97.33 97.33 194.66 Physicians and Surgeons, All Other ...... 29–1069 95.05 95.05 190.10 Statistician ...... 15–2041 40.60 40.60 81.20

As indicated, we are adjusting our not believe the individual EP or group in the PQRS burden. We estimate there employee hourly wage estimates by a practice incurs any additional burden. were approximately 1,947 EPs that are factor of 100 percent. This is necessarily The associated reporting burden which part of the 218 participant TINs that are a rough adjustment, both because fringe is currently approved by OMB under under the 8 ACOs that failed to benefits and overhead costs vary control number 0938–1059 (CMS– successfully report their 2015 quality significantly from employer to 10276) explains that the PQRS annual data. There is no change in the reporting employer, and because methods of burden estimate was calculated mechanisms or reporting criteria for estimating these costs vary widely from separately for (1) individual eligible PQRS. It is important to note that if the study to study. Nonetheless, there is no professionals and group practices using ACO fails to report on behalf of an EP practical alternative and we believe that the claims (for eligible professionals or group practice and the EP or group doubling the hourly wage to estimate only), (2) qualified registry and QCDR, practice does not utilize this secondary total cost is a reasonably accurate (3) EHR-based reporting mechanisms, reporting period they may be subject to estimation method. and (4) group practices using the GPRO. a downward adjustment. We did not receive any comments We estimated that ALL 1.25 million B. Information Collection Requirements pertaining to our position that the eligible professionals will participate in (ICRs) and Burden Estimates proposed rule would not set out any the PQRS in 2016 for purposes of 1. ICRs Regarding the Physician Quality additional requirements or burden. meeting the criteria for satisfactory Reporting System (PQRS) (§ 414.90) Consequently, we are restating our reporting (or, in lieu of satisfactory position without change. For individual EPs or group practices, reporting, satisfactory participation in a who choose to separately report quality QCDR) for the 2018 PQRS payment 2. ICRs Regarding Appropriate Use measures during the secondary PQRS adjustment. This is a high estimate Criteria for Advanced Diagnostic reporting period for the 2017 PQRS according to the 2014 PQRS Reporting Imaging Services (§ 414.94) payment adjustment, who bill under the Experience and Trends Report which Consistent with section 1834(q) of the TIN of an ACO participant if the ACO found approximately 822,000 EPs Act (as amended by section 218(b) of the failed to report on behalf of such EPs or participated in PQRS in 2014. PAMA), we have established specific group practices during the previously Therefore, the additional EPs who requirements for clinical decision established reporting period for the choose to report separately from the support mechanisms (CDSMs) that can 2017 PQRS payment adjustment, we do ACOs have already been accounted for be qualified CDSMs under § 414.94 as

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part of the Medicare appropriate use demographic information of each compile, review and submit criteria (AUC) program. CDSMs that unique consultation for a minimum of 6 documentation demonstrating believe they meet the requirements to be years; (13) complies with adherence to the CDSM requirements. qualified CDSMs (for the purpose of this modification(s) to any requirements We anticipate 30 respondents based on section) may apply to CMS to be under § 414.94(g)(1) made through the number of existing CDSMs that have specified as a qualified CDSM. rulemaking within 12 months of the expressed an interest in incorporating Applications must be submitted effective date of the modification; and AUC for advanced diagnostic imaging, electronically and demonstrate how the (14) notifies ordering professionals upon as well as our estimation of the number CDSM meets the requirements under de-qualification. of CDSM developers that may be § 414.94(g)(1). Specifically, applications To be specified as a qualified CDSM interested in incorporating AUC for must demonstrate how the CDSM: (1) by CMS, applicants must document advanced diagnostic imaging in the Makes available specified applicable adherence to the requirements in their future as their mechanisms develop and AUC and its related supporting application for CMS review and use the evolve. Each respondent will documentation; (2) identifies the application process identified in voluntarily compile, review and submit appropriate use criterion consulted if § 414.94(g)(2) which includes: (1) documentation that demonstrates their the CDSM makes available more than Applications submitted by CDSMs adherence to the CDSM requirements one criterion relevant to a consultation documenting adherence to each listed above. for a patient’s specific clinical scenario; requirement outlined in § 414.94(g)(1) We estimate it will take 10 hours at must be received annually by January 1 (3) makes available, at a minimum, $68.18/hr for a business operations except for the first round of applications specified applicable AUC that specialist to compile, prepare and following publication of the CY 2017 reasonably address common and submit the required information, 2.5 PFS Final Rule which will be due by important clinical scenarios within all hours at $86.72/hr for a computer March 1, 2017; (2) CDSMs with priority clinical areas identified in system analyst to review and approve applications that document adherence § 414.94(e)(5); (4) is able to incorporate the submission, 2.5 hours at $135.58/hr to all requirements under § 414.94(g)(1) specified applicable AUC from more for a computer and information systems may receive full qualification and than one qualified PLE; (5) determines, manager to review and approve the CDSMs with applications that cannot for each consultation, the extent to submission, and 5 hours at $131.02/hr document adherence to each for a lawyer to review and approve the which the applicable imaging service is requirement must document how and consistent with a specified applicable submission. In this regard, we estimate when each requirement is reasonably 20 hours per submission at a cost of AUC; (6) generates and provides a expected to be met and may receive certification or documentation at the $1,892.65. In aggregate, we estimate 600 preliminary qualification; (3) the hours (20 hr × 30 submissions) at time of order each time an ordering preliminary qualification period begins $56,779.50 ($1,892.65 × 30 professional consults a qualified CDSM June 30, 2017 and ends when CMS submissions). that includes a unique consultation implements sections 1834(q)(4)(A) and identifier that documents: Which 1834(q)(4)(B) of the Act; (4) CDSMs with After the anticipated initial 30 qualified CDSM was consulted, the preliminary qualification that fail to respondents, we expect less than 10 name and national provider identifier meet all requirements by the end of the applicants to apply to become qualified (NPI) of the ordering professional that preliminary qualification period will CDSMs annually. Since we estimate consulted the CDSM, whether the not be automatically converted to fewer than 10 respondents, the service ordered would adhere to qualified status; (5) all qualified CDSMs information collection requirements and specified applicable AUC, whether the specified by CMS in each year will be burden are exempt (5 CFR 1320.2(c)) service ordered would not adhere to included on the list of specified from the requirements of the Paperwork specified applicable AUC, or whether qualified CDSMs posted to the CMS Reduction Act of 1995 (44 U.S.C. 3501 the specified applicable AUC consulted Web site by June 30 of that year; (6) et seq). was not applicable to the service qualified CDSMs are specified by CMS Given that qualified CDSMs must re- ordered; (7) updates AUC content as such for a period of 5 years; and (7) apply every 5 years, in years 6–10, we within 12 months from the date the qualified CDSMs are required to re- expect the initial 30 entities will re- qualified PLE updates AUC; (8) has a apply during the 5th year after they are apply. The ongoing burden for re- protocol in place to expeditiously specified by CMS to maintain their applying is expected to be half the remove AUC determined by the status as qualified CDSMs and the burden of the initial application qualified PLE to be potentially applications must be received by CMS process. The CDSM developers will be dangerous to patients and/or harmful if by January 1 of the 5th year after the able to make modifications to their followed; (9) makes available specified most recent approval date. If a qualified original application which should result applicable AUC that reasonably address CDSM is found to be non-adherent to in a burden of 5 hours at $68.18/hr for common and important clinical the requirements identified above, CMS a business operations specialist to scenarios within any new priority may terminate its qualified status or compile, prepare and submit the clinical area for consultation through may consider this information during required information, 1.25 hours at the qualified CDSM within 12 months of re-qualification. $86.72/hr for a computer system analyst the priority clinical area being finalized The one-time burden associated with to review and approve the submission, by CMS; (10) meets privacy and security the requirements under § 414.94(g)(2) is 1.25 hours at $135.58/hr for a computer standards under applicable provisions the time and effort it will take each of and information systems manager to of law; (11) provides the ordering the approximately 30 CDSM developers review and approve the submission, and professional aggregate feedback (as estimated by CMS, the Office of the 2.5 hours at $131.02/hr for a lawyer to regarding their consultations with National Coordinator (ONC), and the review and approve the submission. specified applicable AUC in the form of Agency for Healthcare Research and Annually, we estimate 10 hours per an electronic report on at least an Quality (AHRQ)) that have interests in submission at a cost of $946.33 per annual basis; (12) maintains electronic incorporating AUC consultation into CDSM developer. In aggregate, we storage of clinical, administrative, and their mechanisms’ functionality to estimate 300 hours (10 hr × 30

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submissions) at $28,389.90 ($946.33 × priority clinical areas;’’ (2) a new area of medicine to reflect the imaging 30 submissions). requirement that qualified CDSMs services that they order most often. In response to public comments, we notify ordering professionals upon de- We continue to believe that all tools added a new requirement under qualification; and (3) a new preliminary should contain the specified applicable § 414.94(g)(1)(xii) whereby CDSMs are qualification period for CDSMs that AUC needed by the ordering required to notify ordering professionals apply for qualification during the first professionals they serve, as well as upon de-qualification. We estimate that application period but do not fully meet contain specified applicable AUC 1 CDSM will be de-qualified each year. all requirements under § 414.94(g)(1). related to the priority clinical areas to Because this disclosure is required of Comment: The majority of ensure that if the professional needs to less than 10 entities, the PRA is not commenters addressed the proposal to order an imaging service then they will applicable. require CDSMs to contain, at a not have to go outside their regular The aforementioned requirements and minimum, AUC that encompass the qualified CDSM for the consultation. We burden will be submitted to OMB under entire clinical scope of priority clinical reiterate that we envision having a given control number 0938–1315 (CMS– areas. Commenters were split regarding qualified CDSM allow efficient access to 10624). the proposed requirement. Some ordering professionals of one or more As regulatory requirements become commenters suggested that CDSMs specialty-focused specified applicable more complex, we will look to requiring minimum AUC content would AUC sets along with more innovative technologies that minimize add cost and be unnecessary for CDSMs comprehensive specified applicable the burden on an organizations’ budget that serve specialists. They favored AUC sets. We believe the determination and manpower. To this end, the CDSM CDSMs determining, along with the of which AUC sets are made accessible functionality requirements identified in ordering practitioners they serve, what through a given CDSM should be § 414.94(g)(1) will help practitioners AUC content would be made available. demand-driven by ordering meet the requirements of the AUC Other commenters favored requiring professionals, who would be choosing program. While the CDSM application every CDSM to contain comprehensive from a marketplace of options for both process in § 414.94(g)(2) is a new AUC. Those commenters said this was CDSMs and AUC, all of which meet burden under this program, the CDSM the intent of the PAMA since ordering basic CMS qualifications to ensure functionality requirements in professionals must consult for every implementation of the PAMA statutory § 414.94(g)(1) do not add burden as they advanced diagnostic imaging order and requirements. are functions of the CDSM. These To balance the requirement for the takes into account the lessons learned mechanisms function consistently with minimum floor, we believe it is from the MID to avoid ordering their voluntary and individualized important to reconsider the extent to practitioners from consulting for design so the requirements in which specified applicable AUC imaging services and not finding § 414.94(g)(1) are either part of a encompass the entire clinical scope of relevant AUC within their CDSM. Other mechanism’s functionality or not. If priority clinical areas. We agree that CDSM developers wish their CDSMs to commenters agreed with a minimum requiring the entire clinical scope may become qualified under this program, floor of AUC but expressed concerned not yield consultation of the highest they may choose to develop the about the way CMS proposed that the quality specified applicable AUC and functionality of their mechanisms priority clinical areas must be addressed that ordering professionals, particularly consistent with these requirements to be stating that encompassing the entire specialists, may not require specified qualified, but all CDSMs are not clinical scope of priority clinical areas applicable AUC addressing the entire required to participate in this program. is not preferred and would draw in AUC clinical scope of a priority clinical area. For example, a CDSM that does not without a strong evidence base. Therefore, we agree with commenters incorporate AUC for any advanced Response: We understand the who suggested we keep the AUC floor diagnostic imaging services would significance of this aspect of the but allow the requirement to be fulfilled likely choose not to seek to become proposal, as well as the statements made if specified applicable AUC address less qualified under this Medicare AUC by the commenters both for and against than the entire scope of the priority program. As such, only CDSMs that the requirement of an AUC floor related clinical areas and instead reasonably wish to participate in the Medicare AUC to priority clinical areas. We reiterate address the common and important for advanced diagnostic imaging that, in alignment with statute, ordering clinical scenarios within each priority services program are required to apply professionals must consult for each clinical area. for qualification and, in choosing to advanced diagnostic imaging service Comment: Some commenters seek qualification, CDSM developers ordered. Therefore, we believe many expressed concerns regarding CDSMs would also choose to incorporate the professionals will choose a qualified that either fail to requalify after the first requirements into their mechanism’s CDSM that best fits their ordering 5-year qualification period or are found functionality. patterns and clinical practice. Those to no longer be adherent to CDSM We received public comments (see ordering a wide array of imaging requirements during the 5-year below) regarding our proposed services or perhaps infrequently qualification period. One commenter requirements and burden estimates. We ordering imaging services across a recommended that CDSMs be considered the comments and are spectrum will align themselves with a temporarily suspended before being largely adopting the proposed mechanism that fits their needs and disqualified. Other commenters provisions with minimal changes to contains comprehensive specified recommended that CMS ensure improve clarity. Three areas where we applicable AUC so when the qualified providers using these mechanisms not have made more significant changes CDSM is consulted they will lessen be penalized while they seek a new include: (1) Revising the proposed their chances of the qualified CDSM mechanism for consultation. Another requirement for CDSMs to ‘‘reasonably identifying no applicable AUC as this commenter suggested that the CDSM be encompass the entire clinical scope of was a major frustration of the MID. required to notify ordering professionals all priority clinical areas’’ to now Specialists may seek to align of such a disqualification. Other ‘‘reasonably address common and themselves with a qualified CDSM that commenters requested that qualification important clinical scenarios within all contains AUC more exhaustive in one of CDSMs not be disrupted due to

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standard technical updates to CDSMs are enrolled in Medicare. Through our estimate 96,000 hours at a cost of made during the 5-year qualification analysis of currently available encounter $6,843,520. period. data provided by MA organizations, we For physicians and non-physician Response: We agree and do not have found that some providers and practitioners, the requirements and foresee penalties under these suppliers that furnish items or services circumstances or disqualification of a annualized burden (32,000 hours) will to MA organization enrollees are not be submitted to OMB under control CDSM due to a standard update enrolled in Medicare in an approved number 0938–0685 (Form CMS–855I) assuming no changes are made to status. Based on preliminary data, we because physicians and non-physician functionality that result in non- estimate that 64,000 MA providers and practitioners enroll via the Form CMS– adherence to the CDSM requirements in suppliers will have to enroll in 855I. For organizations, the § 414.94(g)(1). We agree that qualified Medicare under § 422.222 in order to CDSMs be required to notify ordering treat enrollees. requirements and annualized burden of professionals in the event of 64,000 hours (192,000 hours/3 years) disqualification and have added this About half of the approximately will be submitted to OMB under control requirement under § 414.94(g)(1). 64,000 unenrolled providers and number 0938–0685 (21,333.3 hours for Comment: Some commenters cited suppliers, or 32,000, are individuals and Form CMS–855A and 21,333.3 hours for insufficient time for CDSMs to the other half are organizations. We do Form CMS–855B) and control number incorporate requirements between the not have data at this point to confirm 0938–1056 (21,333.3 hours for Form the number of unenrolled individuals release of the final CDSM requirements, CMS–855S). The specific form to be who are physicians as opposed to non- on or around November 1, 2016, and the completed will depend upon the physician practitioners. For purposes of January 1, 2017 due date for qualified provider or supplier type at issue. For fulfilling the requirements of the PRA, CDSM applications. These commenters instance, and consistent with current requested that CMS delay the deadline we will project that one-half (16,000) are enrollment policy, certified providers and accept applications later into the physicians and the other half (16,000) and certain certified suppliers will year for this first round of applicants. are practitioners. Due to the limited time between complete the Form CMS–855A; group Consistent with our prior time (per practices, ambulance suppliers, and finalization of CDSM requirements and respondent) estimates, we project that it certain other supplier types will the application deadline, another will take 3 hours at $194.66/hr for a complete the Form CMS–855B; commenter recommended that CDSMs physician and $93.30/hr for a non- suppliers of durable medical equipment, be qualified based on their commitment physician practitioner to complete their to support required functionality, rather individual enrollments. For prosthetics, orthotics and supplies than an attestation that the existing organizations (office and administrative (DMEPOS) will complete the Form functionality is fully implemented in a support personnel), we estimate it will CMS–855S. CDSM. take 6 hours at $34.94/hr, since Please note that breakout of the Response: We recognize the challenge organizational enrollees typically must organization burden (dividing 64,000 CDSM developers may have submitting submit more data than individual hours by 3 forms) is an estimate. applications by January 1, 2017, and enrollees. For physicians, we estimate a Logistically, this is necessary for the have extended the deadline only for the total burden of 48,000 hours (16,000 purposes of submitting burden for first round of applications to March 1, applicants × 3 hours) at a cost of 2017. To this end, all CDSMs qualified approval. We have no way of estimating $9,343,680 (48,000 hr × $194.66/hr). For the number of providers/suppliers that in this round only, receive preliminary non-physician practitioners, we qualification to conclude at such time as will complete the individual forms. We estimate 48,000 hours (16,000 welcomed comments on this issue to we implement the consultation and × applicants 3 hours) at a cost of help us derive a more reliable breakout reporting requirements of this AUC $4,478,400 (48,000 hr × $93.30/hr). For program. but received none. Nor did we receive organizations, we estimate 192,000 comments pertaining to any other hours (32,000 applicants × 6 hours) at a 3. ICRs Regarding the Enrollment of MA aspects of the proposed requirements or Providers, Suppliers, and First-Tier, cost of $6,708,480 (192,000 hr × $34.94). burden. Consequently, we are adopting Downstream, and Related Entities In aggregate, we estimate 288,000 hours our proposed requirements and burden (FDRs) (§ 422.222) at $20,530,560. estimates without change. There are approximately 1.9 million When projected annually over OMB’s providers and suppliers nationwide that maximum 3-year approval period, we

TABLE 48—CMS–855 BURDEN IMPLICATIONS

Individuals Organizations (32,000 total respondents) (32,000 total respondents) (3 hours/application) (6 hours/application)

CMS–855–I (32,000) ...... 32,000 respondents, 96,000 hours. Physicians (16,000) $194.66/hour ...... 16,000 physicians × 3 hours = 48,000 hours @$194.66 = $9,343,680.00. Non-physician Practitioners (16,000) $93.30/ 16,000 non-physician practitioners × 3 hours hour. = 48,000 hours @$93.30 = $4,478,400.00. CMS–855–A (10,666) $34.94/hour ...... 10,666 respondents × 6 hours = 63,996 hours 10,666 respondents × 6 hours = 63,996 hours @$34.94 = $2,236,020.24 CMS–855–B (10,666) ...... 10,666 respondents × 6 hours = 63,996 hours 10,666 respondents × 6 hours = 63,996 hours @$34.94 = $2,236,020.24

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TABLE 48—CMS–855 BURDEN IMPLICATIONS—Continued

Individuals Organizations (32,000 total respondents) (32,000 total respondents) (3 hours/application) (6 hours/application)

CMS–855–S (10,666) ...... 10,666 respondents × 6 hours = 63,996 hours 10,666 respondents × 6 hours = 63,996 hours @$34.94 = $2,236,020.24

Sub-total respondents ...... 32,000 respondents ...... 32,000 respondents Sub-total hours ...... 96,000 hours ...... 192,000 hours Sub-total cost ...... $13,822,080.00 ...... $6,708,060.72

Total ...... 64,000 respondents, 288,000 hours, $20,530,140.72

4. ICRs Regarding the Release of includes the data needed by the MAO or operational costs to MA Medicare Advantage Bid Pricing Data or Part D sponsor to calculate and verify organizations. Many MA organizations (§ 422.272) and the Release of Part C and the MLR and remittance amount, if any, already require Medicare enrollment for Part D Medical Loss Ratio (MLR) Data for each contract. The proposed rule all their network providers and (§§ 422.2490 and 423.2490) provided for the release of the Part C suppliers. So there will be no additional In the proposed rule, new § 422.272 and Part D MLR data contained in the costs to most MA and MA–PD plans. proposed an annual public release of MLR Reports that we receive from The only tangible costs will be to those MA bid pricing data (with specified MAOs and Part D sponsors, with providers or suppliers that are not exceptions from release), which would specified exceptions to release. enrolled and those costs are estimated occur after the first Monday in October We determined for the proposed rule in section IV.B.3. of this final rule. that the proposed provisions on the and would contain MA bid pricing data 6. ICRs Regarding Payment to release of MA bid pricing data and the that was approved by CMS for a contract Organizations That Provide Medicare release of Part C and Part D MLR data year at least 5 years prior to the Diabetes Prevention Program Services did not change any of the existing upcoming calendar year. Under Part C, (§ 424.59) MA organizations (MAOs) are required requirements regarding submission of to submit bid data to CMS each year for bid data and MLR data by MAOs or Part Section 1115A(d)(3) of the Social MA plans they wish to offer in the D plan sponsors, nor did the proposed Security Act exempts the Center for upcoming contract year (calendar year), rule propose any new or revised Medicare and Medicaid Innovation under current authority at § 422.254. reporting, recordkeeping, or third-party (CMMI) model tests and expansions, Proposed §§ 422.2490 (for Part C) and disclosure requirements. We noted that including the Medicare Diabetes 423.2490 (for Part D) also provided for although the proposed provisions have Prevention Program expansion, from the the public release of Part C and Part D no impact on respondent requirements PRA. The section provides that Chapter MLR data for each contract year, which or burden, the changes have been 35 of title 44, United States Code, which would occur no sooner than 18 months submitted to OMB for approval under includes such provisions as the PRA, after the end of the contract year for control number 0938–0944 (CMS– shall not apply to the testing and which the MLR Report was submitted. 10142) for MA bid pricing data and evaluation of CMMI models or Starting with contract year 2014, if an 0938–1232 (CMS–10476) for Part C and expansion of such models. MAO or Part D sponsor fails to spend at Part D MLR data. least 85 percent of the revenue received We did not receive any comments on 7. ICRs Regarding the Medicare Shared under an MA or Part D contract on the proposed requirements or burden Savings Program (Part 425) incurred claims and quality and are finalizing them without change. Section 1899(e) of the Act provides improvement activities, the MAO or that chapter 35 of title 44 of the U.S. Part D sponsor must remit to the 5. ICRs Regarding Application Code, which includes such provisions Secretary the product of: (1) The Requirements (§ 422.501) and as the PRA, shall not apply to any contract’s total revenue; and (2) the Termination of Contract by CMS information collection activities under difference between 85 percent and the (§ 422.510) the Shared Savings Program. contract’s MLR. For each contract year, Changes to §§ 422.501 and 422.510 each MAO and Part D sponsor must involve only CMS contract changes and C. Summary of Annual Burden submit an MLR Report to CMS which will not result in any external charges Estimates

TABLE 49—ANNUAL RECORDKEEPING AND REPORTING REQUIREMENTS

Regulation sec- Burden per Total annual Labor cost of tion(s) under title OMB control Respondents Total responses response burden reporting Total cost 42 of the CFR No. (hours) (hours) ($) ($) *

§ 414.94(g)(2) ...... 0938–1315 30 30...... 20 600 varies ...... 56,780 § 414.94(g)(2) (re- 30 ...... 10 300 varies ...... 28,390 apply). § 422.222 (physi- 0938–0685 32,000 10,666.6 (32,000 3 32,000 varies...... 4,607,360 cians and non- responses physician practi- annualized over 3 tioners). years).

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TABLE 49—ANNUAL RECORDKEEPING AND REPORTING REQUIREMENTS—Continued

Regulation sec- Burden per Total annual Labor cost of tion(s) under title OMB control Respondents Total responses response burden reporting Total cost 42 of the CFR No. (hours) (hours) ($) ($) *

§ 422.222 (organi- 0938–0685 32,000 7,111.1 for two 6 42,666.6 34.94...... 1,490,771 zations). CMS–855 forms (21,333.3 responses annualized over 3 years). § 422.222 (organi- 0938–1056 ...... 3,555.6 for one 6 21,333.3 34.94...... 745,386 zations). CMS–855 form.

Total ...... 64,030 21,393 ...... 96,900 varies ...... 6,928,687 * This rule does not set out any non-labor costs.

D. Associated Information Collections ACOs on a number of issues policies for Medicare Part B, Part D, and Not Specified in Regulatory Text surrounding pre- and post-operative Medicare Advantage. surgical services. In addition to the PRA This rule references three information B. Overall Impact collection requirements that do not exemption as described above under We examined the impact of this rule pertain to the amendments in the PAMA, the survey is also exempt from as required by Executive Order 12866 regulatory text. While the activities meet the PRA under section 3022 of the on Regulatory Planning and Review the PRA’s definition of an information Affordable Care Act which exempts (September 30, 1993), Executive Order collection requirement, section 220 of collections associated with the Medicare Shared Savings Program. 13563 on Improving Regulation and the Protecting Access to Medicare Act Regulatory Review (February 2, 2013), (PAMA) of 2014 (Pub. L. 113–93) E. Submission of PRA-Related the Regulatory Flexibility Act (RFA) provides that the activities are exempt Comments (September 19, 1980, Pub. L. 96–354), from the requirements of under the We have submitted a copy of this section 1102(b) of the Social Security PRA. The exemption applies to rule’s information collection and Act, section 202 of the Unfunded information collected to ensure the recordkeeping requirements to OMB for Mandates Reform Act of 1995 (March accurate valuation of services under the review and approval. The requirements 22, 1995; Pub. L. 104–4), Executive Physician Fee Schedule which includes are not effective until they have been Order 13132 on Federalism (August 4, but is not limited to surveys of approved by the OMB. 1999) and the Congressional Review Act physicians, other suppliers, providers of To obtain copies of the supporting (5 U.S.C. 804(2)). services, manufacturers, and vendors; statement and any related forms for the Executive Orders 12866 and 13563 surgical logs, billing systems, or other collections discussed above, please visit direct agencies to assess all costs and practice or facility records; electronic CMS’ Web site at http:// benefits of available regulatory health records; and, any other www.cms.hhs.gov/ alternatives and, if regulation is mechanism deemed appropriate by the PaperworkReductionActof1995, or call necessary, to select regulatory Secretary. the Reports Clearance Office at 410– approaches that maximize net benefits The activities consist of the following: 786–1326. (including potential economic, 1. Global Surgical Services We invite public comments on these environmental, public health and safety Section II.D.2. of this final rule details potential information collection effects, distributive impacts, and our plans for a claims-based reporting requirements. If you wish to comment, equity). A regulatory impact analysis program for global surgical services. Our please identify the rule (CMS–1654–F) (RIA) must be prepared for major rules claims-based data collection is and submit your comments to the OMB with economically significant effects applicable to 10- and 90-day global desk officer via one of the following ($100 million or more in any 1 year). We services furnished on or after January 1, transmissions: estimate, as discussed in this section, Mail: OMB, Office of Information and 2017, which will set out: Who will be that the PFS provisions included in this Regulatory Affairs, Attention: CMS Desk required to report, what they will be final rule would redistribute more than Officer, required to report, and how the reports $100 million in 1 year. Therefore, we Fax Number: 202–395–5806 OR, will be submitted. estimate that this rulemaking is Email: OIRA_submission@ ‘‘economically significant’’ as measured 2. Survey of Practitioners omb.eop.gov. by the $100 million threshold, and PRA-related comments must be As discussed earlier in section hence also a major rule under the received on/by December 2, 2016. II.D.6.e.(1) through (2) of this final rule, Congressional Review Act. Accordingly, we intend to conduct a survey of V. Regulatory Impact Analysis we prepared an RIA that, to the best of practitioners to help us explore options our ability, presents the costs and A. Statement of Need and collect data with respect to benefits of the rulemaking. The RFA assessing and revaluing the global This final rule makes payment and requires agencies to analyze options for surgery services. policy changes under the Medicare PFS regulatory relief of small entities. For and makes required statutory changes purposes of the RFA, small entities 3. Data Collection for Accountable Care under the MACRA, ABLE, PAMA, and include small businesses, nonprofit Organizations the Consolidated Appropriations Act of organizations, and small governmental In section II. D.6.e.(3) of this final 2016. This final rule also makes changes jurisdictions. Most hospitals, rule, we intend to conduct a survey of to payment policy and other related practitioners and most other providers

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and suppliers are small entities, either threshold is approximately $146 furnishes. The average percentage by nonprofit status or by having annual million. This final rule will impose no change in total revenues would be less revenues that qualify for small business mandates on state, local, or tribal than the impact displayed here because status under the Small Business governments or on the private sector. practitioners and other entities generally Administration standards. (For details Executive Order 13132 establishes furnish services to both Medicare and see the SBA’s Web site at http:// certain requirements that an agency non-Medicare patients. In addition, www.sba.gov/content/table-small- must meet when it issues a proposed practitioners and other entities may business-size-standards (refer to the rule (and subsequent final rule) that receive substantial Medicare revenues 620000 series)). Individuals and states imposes substantial direct requirement for services under other Medicare are not included in the definition of a costs on state and local governments, payment systems. For instance, small entity. preempts state law, or otherwise has independent laboratories receive The RFA requires that we analyze Federalism implications. Since this approximately 83 percent of their regulatory options for small businesses regulation does not impose any costs on Medicare revenues from clinical and other entities. We prepare a state or local governments, the laboratory services that are paid under regulatory flexibility analysis unless we requirements of Executive Order 13132 the Clinical Lab Fee Schedule. certify that a rule would not have a are not applicable. The annual update to the PFS significant economic impact on a We prepared the following analysis, conversion factor (CF) was previously substantial number of small entities. which together with the information calculated based on a statutory formula; The analysis must include a justification provided in the rest of this preamble, for details about this formula, we refer concerning the reason action is being meets all assessment requirements. The readers to the CY 2015 PFS final rule taken, the kinds and number of small analysis explains the rationale for and with comment period (79 FR 67741 entities the rule affects, and an purposes of this final rule; details the through 67742). Section 101(a) of the explanation of any meaningful options costs and benefits of the rule; analyzes MACRA repealed the previous statutory that achieve the objectives with less alternatives; and presents the measures update formula and amended section significant adverse economic impact on we would use to minimize the burden 1848(d) of the Act to specify the update the small entities. on small entities. As indicated adjustment factors for calendar years Approximately 95 percent of elsewhere in this final rule, we are 2015 and beyond. For CY 2017, the practitioners, other providers, and implementing a variety of changes to specified update is 0.5 percent before suppliers are considered to be small our regulations, payments, or payment applying other adjustments. entities, based upon the SBA standards. policies to ensure that our payment Section 220(d) of the PAMA added a There are over 1 million physicians, systems reflect changes in medical new paragraph at section 1848(c)(2)(O) other practitioners, and medical practice and the relative value of of the Act to establish an annual target suppliers that receive Medicare services, and implementing statutory for reductions in PFS expenditures payment under the PFS. Because many provisions. We provide information for resulting from adjustments to relative of the affected entities are small entities, each of the policy changes in the values of misvalued codes. Under the analysis and discussion provided in relevant sections of this final rule. We section 1848(c)(2)(O)(ii) of the Act, if the this section, as well as elsewhere in this are unaware of any relevant federal net reduction in expenditures for the final rule is intended to comply with the rules that duplicate, overlap, or conflict year is equal to or greater than the target RFA requirements regarding significant with this final rule. The relevant for the year, reduced expenditures impact on a substantial number of small sections of this final rule contain a attributable to such adjustments shall be entities. description of significant alternatives if redistributed in a budget-neutral In addition, section 1102(b) of the Act manner within the PFS in accordance applicable. requires us to prepare an RIA if a rule with the existing budget neutrality may have a significant impact on the C. Changes in Relative Value Unit requirement under section operations of a substantial number of (RVU) Impacts 1848(c)(2)(B)(ii)(II) of the Act. Section small rural hospitals. This analysis must 1848(c)(2)(O)(iii) of the Act specifies 1. Resource-Based Work, PE, and MP conform to the provisions of section 604 that, if the estimated net reduction in RVUs of the RFA. For purposes of section PFS expenditures for the year is less 1102(b) of the Act, we define a small Section 1848(c)(2)(B)(ii)(II) of the Act than the target for the year, an amount rural hospital as a hospital that is requires that increases or decreases in equal to the target recapture amount located outside of a Metropolitan RVUs may not cause the amount of shall not be taken into account when Statistical Area for Medicare payment expenditures for the year to differ by applying the budget neutrality regulations and has fewer than 100 more than $20 million from what requirements specified in section beds. We did not prepare an analysis for expenditures would have been in the 1848(c)(2)(B)(ii)(II) of the Act. We section 1102(b) of the Act because we absence of these changes. If this estimate the CY 2017 net reduction in determined, and the Secretary certified, threshold is exceeded, we make expenditures resulting from adjustments that this final rule would not have a adjustments to preserve budget to relative values of misvalued codes to significant impact on the operations of neutrality. be 0.32 percent. Since this amount does a substantial number of small rural Our estimates of changes in Medicare not meet the 0.5 percent target hospitals. expenditures for PFS services compare established by the Achieving a Better Section 202 of the Unfunded payment rates for CY 2016 with Life Experience Act of 2014 (ABLE) Mandates Reform Act of 1995 also proposed payment rates for CY 2017 (Division B of Pub. L. 113–295, enacted requires that agencies assess anticipated using CY 2015 Medicare utilization. The December 19, 2014), payments under costs and benefits on state, local, or payment impacts in this final rule the fee schedule must be reduced by the tribal governments or on the private reflect averages by specialty based on difference between the target for the sector before issuing any rule whose Medicare utilization. The payment year and the estimated net reduction in mandates require spending in any 1 year impact for an individual practitioner expenditures, known as the target of $100 million in 1995 dollars, updated could vary from the average and would recapture amount. As a result, we annually for inflation. In 2016, that depend on the mix of services he or she estimate that the CY 2017 target

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recapture amount will produce a included in PFS budget neutrality. We by the target recapture amount, the reduction to the conversion factor of note that the application of the 25 budget neutrality adjustment and the ¥0.18 percent. percent MPPR has been applied in a imaging MPPR adjustment described in Effective January 1, 2012, we budget neutral fashion to date. the preceding paragraphs. We estimate The CY 2017 final PFS rates exclude implemented an MPPR of 25 percent on the CY 2017 PFS conversion factor to be the 5 percent MPPR for the professional the professional component (PC) of 35.8887, which reflects the budget component of imaging services by advanced imaging services. Section neutrality adjustment, the 0.5 percent calculating the rates as if the discount 502(a)(2)(A) of Division O, Title V of the update adjustment factor specified does not occur, consistent with our under section 1848(d)(18) of the Act, the Consolidated Appropriations Act of approach to other discounts that occur 2016 (Pub. L 114–113, enacted on adjustment due to the non-budget outside of PFS budget neutrality. In neutral 5 percent MPPR for the December 18, 2015) added a new order to implement the change from the section 1848(b)(10) of the Act, which professional component of imaging 25 percent discount in 2016 to the 5 services, and the ¥0.18 percent target revises the MPPR on the professional percent discount in 2017 within PFS component of imaging services from 25 recapture amount required under budget neutrality, we measured the section 1848(c)(2)(O)(iv) of the Act and percent to 5 percent, effective January 1, difference in total RVUs for the relevant 2017. Section 502(a)(2)(B) of Division O, described above. We estimate the CY services, assuming an MPPR of 25 2017 anesthesia conversion factor to be Title V of the Consolidated percent and the total RVUs for the same Appropriations Act of 2016 added a 22.0454, which reflects the same overall services without an MPPR, and then PFS adjustments. new subclause at section applied that difference as an adjustment 1848(c)(2)(B)(v)(XI) which exempts the to the conversion factor to account for We note that the proposed RVU MPPR reductions attributable to the new the increased expenditures attributable budget neutrality adjustment was 5 percent MPPR on the PC of imaging to the change, within PFS budget negative, due to the estimated overall from the PFS budget neutrality neutrality. This approach is consistent increases in proposed RVUs relative to provision. However, the provision does with the statutory provision that 2016. However, because we did not not exempt the change attributable to requires the 5 percent MPPR to be finalize the proposed changes to make the 25 percent MPPR from PFS budget implemented outside of PFS budget separate payment for the additional neutrality. Therefore, for CY 2017 we neutrality. resource costs involved in mobility must calculate PFS rates in a manner To calculate the final conversion impairment services, we are finalizing that exempts the 5 percent MPPR from factor for this year, we multiplied the an overall decrease in RVUs relative to budget neutrality but ensures that the product of the current year conversion 2016. This results in an RVU budget elimination of the 25 percent MPPR is factor and the update adjustment factor neutrality adjustment that is positive.

TABLE 50—CALCULATION OF THE FINAL CY 2017 PFS CONVERSION FACTOR

Conversion factor in effect in CY 2016 35.8043

Update Factor ...... 0.50 percent (1.0050). CY 2017 RVU Budget Neutrality Adjustment ...... ¥0.013 percent (0.99987). CY 2017 Target Recapture Amount ...... ¥0.18 percent (0.9982). CY 2017 Imaging MPPR Adjustment ...... ¥0.07 percent (0.9993). CY 2017 Conversion Factor ...... 35.8887

TABLE 51—CALCULATION OF THE FINAL CY 2017 ANESTHESIA CONVERSION FACTOR (CM ESTIMATE)

CY 2016 National Average Anesthesia Conversion Factor 21.9935

Update Factor ...... 0.50 percent (1.0050). CY 2017 RVU Budget Neutrality Adjustment ...... 0.013 percent (0.99987). CY 2017 Target Recapture Amount ...... ¥0.18 percent (0.9982). CY 2017 Imaging MPPR Adjustment ...... ¥0.07 percent (0.9993). CY 2017 Conversion Factor ...... 22.0454

Table 52 shows the payment impact • Column B (Allowed Charges): The estimated CY 2017 impact on total on PFS services of the proposals aggregate estimated PFS allowed allowed charges of the changes in the contained in this final rule. To the charges for the specialty based on CY work RVUs, including the impact of extent that there are year-to-year 2015 utilization and CY 2016 rates. That changes due to potentially misvalued changes in the volume and mix of is, allowed charges are the PFS amounts codes. services provided by practitioners, the for covered services and include • Column D (Impact of PE RVU actual impact on total Medicare coinsurance and deductibles (which are Changes): This column shows the revenues would be different from those the financial responsibility of the estimated CY 2017 impact on total shown in Table 52 (CY 2017 PFS beneficiary). These amounts have been allowed charges of the changes in the PE Estimated Impact on Total Allowed summed across all services furnished by RVUs. Charges by Specialty). The following is physicians, practitioners, and suppliers • Column E (Impact of MP RVU an explanation of the information within a specialty to arrive at the total Changes): This column shows the represented in Table 52. allowed charges for the specialty. estimated CY 2017 impact on total • Column A (Specialty): Identifies the • Column C (Impact of Work RVU allowed charges of the changes in the specialty for which data are shown. Changes): This column shows the MP RVUs, which are primarily driven

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by the required five-year review and combined impact on total allowed equal the sum of columns C, D, and E update of MP RVUs. charges of all the changes in the due to rounding. • Column F (Combined Impact): This previous columns. Column F may not column shows the estimated CY 2017

TABLE 52—CY 2017 PFS ESTIMATED IMPACT ON TOTAL ALLOWED CHARGES BY SPECIALTY *

(C) (D) (E) (B) Impact Impact Impact (F) (A) Allowed of work of PE of MP Combined Specialty charges RVU RVU RVU impact ** (mil) changes changes changes (%) (%) (%) (%)

TOTAL ...... $89,866 0 0 0 0 ALLERGY/IMMUNOLOGY ...... 231 0 1 0 1 ANESTHESIOLOGY ...... 1,982 0 0 0 0 AUDIOLOGIST ...... 61 0 0 0 0 CARDIAC SURGERY ...... 324 0 0 0 0 CARDIOLOGY ...... 6,485 0 0 0 0 CHIROPRACTOR ...... 784 0 0 0 0 CLINICAL PSYCHOLOGIST ...... 734 0 0 0 0 CLINICAL SOCIAL WORKER ...... 606 0 0 0 0 COLON AND RECTAL SURGERY ...... 161 0 0 0 0 CRITICAL CARE ...... 311 0 0 0 0 DERMATOLOGY ...... 3,308 0 0 0 0 DIAGNOSTIC TESTING FACILITY ...... 754 0 ¥1 0 ¥1 EMERGENCY MEDICINE ...... 3,145 0 0 0 0 ENDOCRINOLOGY ...... 460 0 0 0 0 FAMILY PRACTICE ...... 6,110 0 1 0 1 GASTROENTEROLOGY ...... 1,747 ¥1 0 0 ¥1 GENERAL PRACTICE ...... 456 0 0 0 1 GENERAL SURGERY ...... 2,172 0 0 0 0 GERIATRICS ...... 213 0 1 0 1 HAND SURGERY ...... 182 0 0 0 0 HEMATOLOGY/ONCOLOGY ...... 1,751 0 0 0 0 INDEPENDENT LABORATORY ...... 706 0 ¥5 0 ¥5 INFECTIOUS DISEASE ...... 656 0 0 0 0 INTERNAL MEDICINE ...... 10,915 0 1 0 1 INTERVENTIONAL PAIN MGMT ...... 769 0 ¥1 0 0 INTERVENTIONAL RADIOLOGY ...... 317 ¥1 0 0 ¥1 MULTISPECIALTY CLINIC/OTHER PHYS ...... 129 0 0 0 1 NEPHROLOGY ...... 2,210 0 0 0 0 NEUROLOGY ...... 1,521 0 0 0 0 NEUROSURGERY ...... 789 ¥1 0 0 ¥1 NUCLEAR MEDICINE ...... 47 0 0 0 0 NURSE ANES/ANES ASST ...... 1,214 0 0 0 0 NURSE PRACTITIONER ...... 2,988 0 0 0 0 OBSTETRICS/GYNECOLOGY ...... 651 0 0 0 0 OPHTHALMOLOGY ...... 5,492 ¥1 ¥2 0 ¥2 OPTOMETRY ...... 1,219 0 ¥1 0 ¥1 ORAL/MAXILLOFACIAL SURGERY ...... 49 0 ¥1 0 ¥1 ORTHOPEDIC SURGERY ...... 3,695 0 0 0 0 OTHER ...... 27 0 0 0 0 OTOLARNGOLOGY ...... 1,210 0 0 0 ¥1 PATHOLOGY ...... 1,135 0 ¥2 0 ¥1 PEDIATRICS ...... 61 0 0 0 0 PHYSICAL MEDICINE ...... 1,068 0 0 0 0 PHYSICAL/OCCUPATIONAL THERAPY ...... 3,407 0 1 0 1 PHYSICIAN ASSISTANT ...... 1,964 0 0 0 0 PLASTIC SURGERY ...... 378 0 0 0 0 PODIATRY ...... 1,972 0 0 0 0 PORTABLE X-RAY SUPPLIER ...... 106 0 0 0 0 PSYCHIATRY ...... 1,265 0 0 0 0 PULMONARY DISEASE ...... 1,765 0 0 0 0 RADIATION ONCOLOGY ...... 1,726 0 0 0 0 RADIATION THERAPY CENTERS ...... 44 0 0 0 0 RADIOLOGY ...... 4,683 0 0 0 ¥1 RHEUMATOLOGY ...... 537 0 0 0 0 THORACIC SURGERY ...... 357 0 0 0 0 UROLOGY ...... 1,772 ¥1 0 0 ¥2 VASCULAR SURGERY ...... 1,046 0 0 0 ¥1 ** Column F may not equal the sum of columns C, D, and E due to rounding.

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2. CY 2017 PFS Impact Discussion b. Impact The most significant changes occur in a. Changes in RVUs Column F of Table 52 displays the 19 non-California payment localities, estimated CY 2017 impact on total where the fully implemented (CY 2018) The most widespread specialty allowed charges, by specialty, of all the GAF moves up by more than 1 percent impacts of the final RVU changes are RVU changes. A table shows the (14 payment localities) or down by more generally related to the changes to RVUs estimated impact on total payments for than 2 percent (5 payment localities). for specific services resulting from the selected high volume procedures of all These changes, required by section Misvalued Code Initiative, including of the changes is available under 1848(e)(6) of the Act, are discussed in finalized RVUs for new and revised ‘‘downloads’’ on the CY 2017 PFS final section II.I. of this final rule. codes. Several specialties, including rule Web site at http://www.cms.gov/ F. Other Provisions of the Proposed interventional radiology and Medicare/Medicare-Fee-for-Service- Regulation independent labs, would experience Payment/PhysicianFeeSched/. We significant decreases to overall selected these procedures for sake of 1. Impact of Changing the Direct payments for services that they illustration from among the most Supervision Requirement to General frequently furnish as a result of commonly furnished by a broad Supervision for CCM Services revisions to the coding structure or the spectrum of specialties. The change in Furnished Incident to RHCs and FQHCs, final inputs used to develop RVUs for both facility rates and the nonfacility and Impact of Revising the CCM the codes that describe particular rates are shown. For an explanation of Requirements for RHCs and FQHCs services. Other specialties, including facility and nonfacility PE, we refer We are finalizing our proposal to endocrinology and family practice, readers to Addendum A on the CMS revise § 405.2413(a)(5) and would experience significant increases Web site at http://www.cms.gov/ § 405.2415(a)(5) to state that services to payments for similar reasons. Medicare/Medicare-Fee-for-Service- and supplies furnished incident to TCM We note that the positive impact for Payment/PhysicianFeeSched/. and CCM services can be furnished CY 2017 several specialties is lower under general supervision of a RHC or D. Effect of Changes in Telehealth List than it was in the proposed rule, FQHC practitioner. This regulatory especially for certain specialties As discussed in section II.I. of this change was already made for CCM disproportionately likely to have final rule, we added several new codes services furnished by practitioners reported the proposed code related to to the list of Medicare telehealth billing the PFS, and changes to RHC and mobility impairment services. Because services. Although we expect these FQHC regulations have no impact on we did not finalize that proposal, we do changes to increase access to care in regulations for practitioners billing not anticipate that shift in payment for rural areas, based on recent utilization under the PFS. The impact of this CY 2017. However, we note that we of similar services already on the change on RHCs and FQHCs in 2017 is believe that many practitioners of those telehealth list, we estimate no negligible, as estimates are rounded to same specialties will likely report the significant impact on PFS expenditures the nearest 5 million and 2017 was too several other new codes described in from the additions relative to overall small of an impact to have a notable section F of this final rule. Based on the PFS expenditures. effect on the estimate. history with other, similar codes, we We are also finalizing our proposal to E. Geographic Practice Cost Indices would anticipate significant changes in revise the CCM requirements for RHCs (GPCIs) allowed charges for these specialties and FQHCs to be consistent with the over a longer period of time thanis Based upon statutory requirements, proposed revisions to the CCM shown by the single year comparison we proposed new GPCIs for each requirements for practitioners billing that we believe is more generally Medicare payment locality. The final under the PFS. These revisions will relevant in displaying the impacts of GPCIs incorporate updated data and allow RHCs and FQHCs to provide TCM changes in payment under the PFS. cost share weights as discussed in and CCM services at the level that was We often receive comments regarding section II.I. The Act requires that projected when the programs were the changes in RVUs displayed on the updated GPCIs be phased in over two authorized, and therefore, no impact on specialty impact table, including years. Addendum D shows the spending is expected. comments received in response to the estimated effects of the revised GPCIs on proposed rates for the current year. We area GAFs for the transition year (CY 2. FQHC-Specific Market Basket remind stakeholders that although the 2017) and the fully implemented year As discussed in section III.B of this estimated impacts are displayed at the (CY 2018). The GAFs reflect the use of final rule, we are finalizing our proposal specialty level, typically the changes are the updated underlying GPCI data, and to create a 2013-based FQHC market driven by the valuation of a relatively the cost share weights remain basket to update the FQHC PPS base small number of new and/or potentially unchanged from the previous (seventh) payment rate. Table 53 shows the 5-year misvalued codes. The percentages in the GPCI update. The GAFs are a weighted and 10-year fiscal cost estimates from table are based upon aggregate estimated composite of each area’s work, PE and switching from a MEI-adjusted base PFS allowed charges summed across all malpractice expense GPCIs using the payment rate to a FQHC PPS market services furnished by physicians, national GPCI cost share weights. basket-adjusted base payment rate. This practitioners, and suppliers within a Although we do not actually use the was determined by compiling data on specialty to arrive at the total allowed GAFs in computing the PFS payment for historical FQHC spending, projecting it charges for the specialty, and compared a specific service, they are useful in forward, and creating two separate to the same summed total from the comparing overall areas costs and baselines. The first baseline assumed an previous calendar year. They are payments. The actual effect on payment MEI price update and the second therefore averages, and may not for any actual service will deviate from baseline assumed an FQHC specific necessarily be representative of what is the GAF to the extent that the market basket price update which was happening to the particular services proportions of work, PE and malpractice created by the Office of the Actuary furnished by a single practitioner within expense RVUs for the service differ from within CMS. The utilization of services any given specialty. those of the GAF. was held constant between the two

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baselines, and therefore, the impact the MEI updates. We estimate that this paid for through beneficiary premiums table specifically captures the change in will cost approximately 210 million and the remaining 165 million would be price from now growing at an FQHC MB dollars over 10 years from FY 2017– paid for through Part B. update relative to how it was growing at 2026, 45 million of which would be

TABLE 53—5-YEAR AND 10-YEAR FISCAL COST ESTIMATES FROM SWITCHING FROM AN MEI-ADJUSTED BASE PAYMENT RATE TO A FQHC PPS MARKET BASKET-ADJUSTED BASE PAYMENT RATE

5-year 10-year Estimate impact impact (in millions) 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 2017– 2017– 2021 2026

FY Cash Impact (with MC) Part B Benefits ...... 5 10 10 15 16 20 25 30 35 45 55 210 Premium Offset...... (5) (5) (5) (5) (5) (10) (10) (10) (45) Total Part B...... 5 10 10 10 10 15 20 25 25 35 45 165

3. Appropriate Use Criteria for release would occur no sooner than 18 Therefore, there is no impact to CY 2017 Advanced Diagnostic Imaging Services months after the end of the contract year physician payments under the PFS. for which MLR data was reported to us. The clinical decision support 7. Recoupment or Offset of Payments to Starting with contract year 2014, each mechanism (CDSM) requirements, as Providers Sharing the Same Taxpayer MAO or Part D sponsor that fails to well as the application process that Identification Number spend at least 85 percent of revenue CDSM developers must comply with for received under an MA or Part D contract This final rule implements section their mechanisms to be specified as on incurred claims and quality 1866(j) of the Act which grants the qualified under this program do not improving activities must remit the Secretary the authority to make any impact CY 2017 physician payments difference to the government. Under necessary adjustments to the payments under the PFS. current authority at § 422.2460 and of an applicable provider of services or 4. Reports of Payments or Other § 423.2460, each year MAOs and Part D supplier who shares a TIN with an Transfers of Value to Covered sponsors must submit an MLR Report to obligated provider of services or Recipients us, which includes the data needed by supplier that has an outstanding the MAO or Part D sponsor to calculate Medicare overpayment. The Secretary is We solicited comments to inform and verify the MLR and remittance authorized to adjust the payments of future rulemaking. We do not intend to amount, if any, for each contract. such applicable provider, regardless of finalize any requirements directly as a We proposed to add regulatory whether that applicable provider is result of this final rule; so there is no language to permit our release of such assigned a different Medicare billing impact to CY 2017 physician payments data to the public. In the proposed rule, number or National Provider Identifier under the PFS. we determined that the proposed (NPI) number from the obligated 5. Release of Part C Medicare Advantage regulatory amendments do not impose provider with the outstanding Medicare Bid Pricing Data and Part C and Part D any mandatory costs on the public or overpayment. The concept of offsetting Medical Loss Ratio (MLR) Data entities that seek to download and use or recouping payments of providers the released data. We expect that this sharing a TIN to satisfy a Medicare Under section III.E. of the preamble of data will be available to the public from overpayment is analogous to Treasury’s this final rule, we describe our proposal the CMS Web site (https:// current practice of offsetting against to revise the existing regulations by www.cms.gov/). The public may elect to entities that share a TIN to collect adding § 422.272 to provide for an download the data files, which will not Medicare overpayments. This final rule annual public release of MA bid pricing impose mandatory costs on any user. will help support our efforts to data (with specified exceptions from Therefore, we determined that there safeguard the Medicare Trust Funds by release). We proposed that the annual were not any significant effects of the collecting its own overpayments more release would occur after the first proposed provisions. We also quickly and reducing the accounts Monday in October and would contain determined that the proposed regulatory receivable delinquency rates reported in MA bid pricing data that was accepted amendments would not impose a the Treasury Report on Receivables. or approved by CMS for a contract year burden on the entity requesting or This final rule also helps the obligated at least 5 years prior to the upcoming downloading the data files. We did not provider because we will collect the calendar year. We noted that under receive any public comments on our overpayments more quickly; thus current authority at § 422.254, MA proposed regulatory impact analysis and reducing the additional interest organizations (MAOs) are required to are finalizing our language as proposed. assessments that would continue on the submit bid pricing data to CMS each provider’s outstanding delinquent 6. Prohibition on Billing Qualified year for MA plans they wish to offer in balance until paid in full. Therefore, Medicare Beneficiary Individuals for the upcoming contract year (calendar there is no impact to CY 2017 physician Medicare Cost-Sharing year). payments under the PFS. In addition, we proposed to add We are restating information to inform § 422.2490 for Part C and § 423.2490 for providers to take steps to educate 8. Medicare Advantage Provider Part D to provide for an annual public themselves and their staff about QMB Enrollment release of Part C and Part D medical loss billing prohibitions and to exempt QMB This final rule will require that ratio (MLR) data (with specified individuals from Medicare cost-sharing providers and suppliers must be exceptions from release). This annual billing and related collection efforts. enrolled in Medicare in approved status

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in order to render services to quality of patient care without reconciliation for ACOs that fall below beneficiaries in the Medicare Advantage increasing spending, and could modify 5,000 assigned beneficiaries and related program. This final rule will not have a the nationwide MDPP as appropriate. In to our policies for consideration of significant economic impact on a this final rule, we are finalizing the claims billed by merged and acquired substantial number of small businesses framework for expansion and finalizing TINs. because the total number of non- details of the MDPP benefit, beneficiary Because the final policies are not enrolled providers and suppliers eligibility criteria, and MDPP supplier expected to substantially change the required to enroll in Medicare to eligibility criteria and enrollment quality reporting burden for ACOs comply with this rule appears to be policies. We will engage in additional participating in the Shared Savings small in comparison to the general rulemaking within the next year to Program and their ACO participants or population of providers and suppliers. address payment, delivery of virtual financial calculations under the Shared The completion of the Form CMS–855 MDPP services, the preliminary Savings Program, we do not anticipate (as explained in section III.) will be recognition standard, use of coach any impact for these final policies. required very infrequently, in many information during enrollment and 11. Value-Based Payment Modifier and cases either only one time or once every monitoring, and other program integrity the Physician Feedback Program several years. Also, the hour and cost safeguards. MDPP policies finalized in burden per provider or supplier will not this rule and those proposed in future Section 1848(p) of the Act requires pose a significant burden on a provider rulemaking will result in changes to our that we establish a value-based payment and supplier, especially when current financial projections and modifier (VM) and apply it to specific considering the overall revenue that therefore affect economic impact physicians and groups of physicians the providers and suppliers receive per estimates of MDPP. For these reasons, it Secretary determines appropriate year. We thus do not believe our is premature to provide an impact starting January 1, 2015 and to all proposal will impact a substantial statement at this time. We intend to physicians and groups of physicians by number of small businesses. provide an impact statement in future January 1, 2017. Section 1848(p)(4)(C) of Virtually all of the quantifiable costs rulemaking. the Act requires the VM to be budget associated with this final rule involve neutral. Budget-neutrality means that, in the paperwork burden to providers and 10. Medicare Shared Savings Program aggregate, the increased payments to suppliers (see section IV. of this final We are finalizing certain rules having high performing physicians and groups rule). The estimates presented in this to do with ACO quality reporting: (1) of physicians equal the reduced section do not address the potential We are finalizing conforming changes to payments to low performing physicians financial benefits of this final rule from align with the policies adopted for the and groups of physicians, as well as the standpoint of the rule’s effectiveness Merit-Based Incentive Payment System those physicians and groups of in preventing or deterring certain (MIPS) and Alternative Payment Models physicians that failed to avoid the PQRS providers from enrolling in or (APMs) in the QPP final rule with payment adjustment as a group or as maintaining their enrollment in comment period including changes to individuals. Medicare. We simply have no means of the quality measure set; (2) we are In the CY 2015 PFS final rule with quantifying these benefits in monetary finalizing a policy to streamline the comment period (79 FR 67936 and terms. quality validation audit process and, 67941 through 67942), we established There are three main uncertainties absent unusual circumstances, to use that, beginning with the CY 2017 associated with this final rule. First, we the results to modify an ACO’s overall payment adjustment period, the VM are uncertain as to the number of quality score; (3) we are finalizing will apply to physicians in groups with providers and suppliers that will be revisions to references to the Quality two or more EPs and to physicians who required to enroll in Medicare under Performance Standard and Minimum are solo practitioners based on the § 422.222. Second, we cannot estimate Attainment Level; (4) we are revising applicable performance period, the savings in fraud and abuse our policies regarding the application of including physicians that participate in prevention that will accrue from this flat percentages to provide that an ACO under the Shared Savings rule. Third, since we have no systematic measures calculated as ratios are Program. In the CY 2014 PFS final rule method to know how many FDRs may excluded from use of flat percentages with comment period (78 FR 74771 be used by MA or MA–PD organizations when such benchmarks appear through 74772), we established CY 2015 to deliver services to Medicare ‘‘clustered’’ or ‘‘topped out’’; and (5) we as the performance period for the VM beneficiaries, therefore, we cannot are modifying our PQRS alignment rules that will be applied to payments during estimate the possible impact to FDRs. to permit flexibility for EPs to report CY 2017. In CY 2017, the VM will be quality data to PQRS to avoid the PQRS waived for groups and solo 9. Expansion of the Diabetes Prevention and VM downward adjustments for practitioners, as identified by their TIN, Program (DPP) Model 2017 and 2018 in cases where an ACO if at least one EP who billed for We proposed to expand the Diabetes fails to report on their behalf. (The rule Medicare PFS items and services under Prevention Program (DPP) Model in can be accessed at https://qpp.cms.gov/ the TIN during 2015 participated in the accordance with section 1115A(c) of the education.) In addition, we are updating Pioneer ACO Model or the Act, and we proposed to refer to this the assignment methodology to include Comprehensive Primary Care initiative expanded model as the Medicare beneficiaries who identify ACO in 2015 (80 FR 71288). Diabetes Prevention Program (MDPP). professionals as being responsible for In the CY 2015 PFS final rule with We proposed that MDPP would become coordinating their overall care. comment period (79 FR 67938 through effective January 1, 2018, and we would We are also finalizing additional 67939), we adopted a two-category continue to test and evaluate MDPP as beneficiary protections when ACOs in approach for the CY 2017 VM based on finalized. In the future, we will assess Track 3 make use of the SNF 3-day rule participation in the PQRS by groups and whether the nationwide implementation waiver under the Shared Savings solo practitioners. Category 1 will of the MDPP is continuing to either Program. Finally, we are finalizing include those groups that meet the reduce Medicare spending without certain technical changes and criteria to avoid the PQRS payment reducing quality of care or improve the clarifications related to financial adjustment for CY 2017 as a group

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practice participating in the PQRS we will use the data reported to the percent for groups of physicians with 10 GPRO in CY 2015. We finalized in the PQRS by the EPs (as a group using one or more EPs and ¥2.0 percent for CY 2016 PFS final rule with comment of the group registry, QCDR, or EHR groups of physicians with between 2 to period (80 FR 71280 through 71281) reporting options or as individuals 9 EPs and physician solo practitioners. that, for the CY 2017 VM, Category 1 using the registry, QCDR, or EHR In the CY 2015 PFS final rule with will also include groups that have at reporting option) under the participant comment period (79 FR 67939 through least 50 percent of the group’s EPs meet TIN) outside of the ACO during the 67941), we finalized that quality-tiering, the criteria to avoid the PQRS payment secondary PQRS reporting period to which is the methodology for evaluating adjustment for CY 2017 as individuals. determine whether the TIN will fall in performance on quality and cost In determining whether a group will be Category 1 or Category 2 under the VM. measures for the VM, will apply to all included in Category 1, we will consider We are finalizing that groups that meet groups of physicians and physician solo whether the 50 percent threshold has the criteria to avoid PQRS payment practitioners in Category 1 for the VM been met regardless of whether the adjustment for CY 2018 as a group for CY 2017. However, groups of group registered to participate in the practice participating in the PQRS physicians with between 2 to 9 EPs and PQRS GPRO in CY 2015. Lastly, GPRO (using one of the group registry, physician solo practitioners will be Category 1 will include those solo QCDR, or EHR reporting options) or subject only to upward or neutral practitioners that meet the criteria to have at least 50 percent of the group’s adjustments derived under quality- avoid the PQRS payment adjustment for EPs meet the criteria to avoid the PQRS CY 2017 as individuals. payment adjustment for CY 2018 as tiering, while groups of physicians with For groups and solo practitioners that individuals (using the registry, QCDR, 10 or more EPs will be subject to participated in an ACO under the or EHR reporting option), based on data upward, neutral, or downward Shared Savings Program in CY 2015, submitted outside the ACO and during adjustments derived under quality- they are considered to be Category 1 for the secondary PQRS reporting period, tiering. That is, groups of physicians the CY 2017 VM if the ACO in which will be included in Category 1 for the with between 2 to 9 EPs and physician they participated successfully reported CY 2017 VM. We are also finalizing that solo practitioners in Category 1 will be on quality measures via the GPRO Web solo practitioners that meet the criteria held harmless from any downward Interface in CY 2015 (79 FR 67946). As to avoid the PQRS payment adjustment adjustments derived under quality- discussed in sections III.H. and III.K.1.e. for CY 2018 as individuals using the tiering for the CY 2017 VM. of this final rule, we are finalizing our registry, QCDR, or EHR reporting Under the quality-tiering proposal to remove the prohibition on option, based on data submitted outside methodology, each group and solo EPs who are part of a group or solo the ACO and during the secondary practitioner’s quality and cost practitioner that participates in a Shared PQRS reporting period, will be included composites will be classified into high, Savings Program ACO, for purposes of in Category 1 for the CY 2017 VM and average, and low categories depending PQRS reporting for the CY 2017 and CY be classified as ‘‘average quality’’ and upon whether the composites are at 2018 payment adjustments, to report ‘‘average cost’’ under the quality-tiering least one standard deviation above or outside the ACO. In section III.L.3.b. of methodology. Category 2 will include below the mean and statistically this final rule, we are finalizing that for those groups and solo practitioners different from the mean. We will the CY 2017 payment adjustment subject to the CY 2017 VM that compare their quality of care composite period, if a Shared Savings Program participate in a Shared Savings Program classification with the cost composite ACO did not successfully report quality ACO and do not fall within Category 1. classification to determine their VM data as required by the Shared Savings The CY 2017 VM payment adjustment adjustment for the CY 2017 payment Program under § 425.504 for the CY amount for groups and solo adjustment period according to the 2017 PQRS payment adjustment, then practitioners in Category 2 is ¥4.0 amounts in Tables 54 and 55.

TABLE 54—CY 2017 VM PAYMENT ADJUSTMENT AMOUNTS UNDER QUALITY-TIERING FOR GROUPS OF PHYSICIANS WITH TWO TO NINE EPS AND PHYSICIAN SOLO PRACTITIONERS

Cost/quality Low quality Average quality High quality

Low cost ...... +0.0% +1.0x* +2.0x* Average cost ...... +0.0% +0.0% +1.0x* High cost ...... +0.0% +0.0% +0.0% * Groups and solo practitioners eligible for an additional +1.0x if reporting measures and average beneficiary risk score is in the top 25 percent of all beneficiary risk scores, where ‘x’ represents the upward payment adjustment factor.

TABLE 55—CY 2017 VM PAYMENT ADJUSTMENT AMOUNTS UNDER QUALITY-TIERING FOR GROUPS OF PHYSICIANS WITH TEN OR MORE EPS

Cost/quality Low quality Average quality High quality

Low cost ...... +0.0% +2.0x* +4.0x* Average cost ...... ¥2.0% +0.0% +2.0x* High cost ...... ¥4.0% ¥2.0% +0.0% * Groups eligible for an additional +1.0x if reporting measures and average beneficiary risk score is in the top 25 percent of all beneficiary risk scores, where ‘x’ represents the upward payment adjustment factor.

Under the quality-tiering practitioners that participated in a reports quality data for CY 2015, the methodology, for groups and solo Shared Savings ACO that successfully cost composite will be classified as

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‘‘Average’’ and the quality of care Category 2 to Category 1 if the group or in the CY 2017 payment adjustment composite will be based on ACO-level solo practitioner satisfactorily report period. These counts include both TINs quality measures. We will compare their their 2016 data during the secondary that participated in a Shared Savings quality of care composite classification PQRS reporting period. Additionally, as Program ACO in CY 2015 and TINs that with the ‘‘Average’’ cost composite we had done when calculating the did not. Of all the physicians subject to classification to determine their VM upward payment adjustment factor for the CY 2017 VM, approximately 65 adjustment for the CY 2017 payment the 2016 VM, we will also incorporate percent of the physicians (577,959 adjustment period according to the adjustments made for estimated changes physicians) are in TINs that met the amounts in Tables 54 and 55. in physician behavior (i.e., changes in criteria for inclusion in Category 1 and We are finalizing in section III.L.3.b. the volume and/or intensity of services are subject to the quality-tiering of this final rule, for groups and solo delivered and shifting of services to methodology in order to calculate their practitioners that participate in a Shared TINs that receive higher VM CY 2017 VM; and approximately 35 Savings Program ACO that did not adjustments) and estimated impact of percent of the physicians (307,149 successfully report quality data for CY pending PQRS and VM informal physicians) are in TINs that are Category 2015 and are in Category 1 as a result reviews. These calculations will be done 2. Physicians in Category 2 TINs with of reporting quality data to the PQRS after the performance period has ended between 1 to 9 EPs will be subject to an outside of the ACO using the secondary and announced around the start of the automatic ¥2.0 percent payment PQRS reporting period, our proposal to payment adjustment year after the adjustment, while physicians in classify their quality composite for the informal review period ends. Category 2 TINs with 10 or more EPs VM for the CY 2017 payment On September 26, 2016, we made the will be subject to an automatic ¥4.0 adjustment period as ‘‘average quality.’’ 2015 Annual QRURs available to all percent payment adjustment under the Their cost composite will be classified groups and solo practitioners based on VM during the CY 2017 payment as ‘‘average cost’’ (79 FR 67943). their performance in CY 2015. We also adjustment period for failing to meet To ensure budget neutrality, we first completed a preliminary analysis (based quality reporting requirements. aggregate the downward payment on results included in the 2015 Annual For physicians (428,461) that are in adjustments in Tables 54 and 55 for QRURs and prior to accounting for the Category 1 TINs that did not participate those groups and solo practitioners in informal review process) of the impact in a Shared Savings Program ACO Category 1 with the automatic of the VM in CY 2017 on physicians in (61,445) in CY 2015, Tables 56 and 57 downward payment adjustments of groups with 2 or more EPs and show the distribution of these ¥2.0 percent or ¥4.0 percent for groups physician solo practitioners based on physicians and TINs with between 1 to and solo practitioners subject to the VM their performance in CY 2015. A 9 EPs and 10 or more EPs, respectively, that fall within Category 2. Using the summary of the results for groups and into the various quality and cost tiers. aggregate downward payment solo practitioners subject to the 2017 The results show that 2,351 TINs adjustment amount, we then calculate VM is presented below. consisting of 12,026 physicians will the upward payment adjustment factor There are 208,832 groups and receive an upward payment adjustment; (x). We plan to incorporate assumptions physician solo practitioners (as 58,099 TINs consisting of 384,922 about the number of physicians in identified by their Taxpayer physicians will receive a neutral groups and physician solo practitioners Identification Number (TIN)) consisting payment adjustment; and 995 TINs in the ACOs that did not successfully of 885,108 physicians whose consisting of 31,513 physicians will report their CY 2015 quality data whose physicians’ payments under the receive a downward payment status could potentially change from Medicare PFS will be subject to the VM adjustment under the VM in CY 2017.

TABLE 56—PRELIMINARY DISTRIBUTION OF CATEGORY 1 NON-SHARED SAVINGS PROGRAM TINS WITH BETWEEN 1 TO 9 EPS (AND PHYSICIANS IN THE TINS) UNDER THE CY 2017 VM [53,119 TINs; 101,168 physicians]

Cost/quality Low quality Average quality High quality

Low Cost ...... +0.0% (6 TINs; 7 physicians) ...... +1.0x (36 TINs; 72 physicians) ...... +2.0x (8 TINs; 28 physicians). +2.0x* (36 TINs; 75 physicians) ...... +3.0x* (11 TINs; 32 physicians). Average Cost ...... +0.0% (4,632 TINs; 9,009 physicians) +0.0% (44,895 TINs; 85,466 physi- +1.0x (1,478 TINs; 2,480 physicians) cians). +2.0x* (531 TINs; 1,104 physicians). High Cost ...... +0.0% (516 TINs; 943 physicians) ...... +0.0% (948 TINs; 1,889 physicians) .... +0.0% (22 TINs; 63 physicians). * These TINs were eligible for an additional +1.0x for reporting measures and having an average beneficiary risk score in the top 25 percent of all beneficiary risk scores.

TABLE 57—PRELIMINARY DISTRIBUTION OF CATEGORY 1 NON-SHARED SAVINGS PROGRAM TINS WITH 10 OR MORE EPS (AND PHYSICIANS IN THE TINS) UNDER THE CY 2017 VM [8,326 TINs; 327,293 physicians]

Cost/quality Low quality Average quality High quality

Low Cost ...... +0.0% (3 TINs; 149 physicians) ...... +2.0x (11 TINs; 383 physicians) ...... +4.0x (0 TINs; 0 physicians). +3.0x* (24 TINs; 2,414 physicians) ...... +5.0x* (3 TINs; 69 physicians). Average Cost ...... ¥2.0% (612 TINs; 17,272 physicians) +0.0% (7,069 TINs; 287,111 physi- +2.0x (95 TINs; 2,439 physicians) cians). +3.0x* (118 TINs; 2,930 physicians).

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TABLE 57—PRELIMINARY DISTRIBUTION OF CATEGORY 1 NON-SHARED SAVINGS PROGRAM TINS WITH 10 OR MORE EPS (AND PHYSICIANS IN THE TINS) UNDER THE CY 2017 VM—Continued [8,326 TINs; 327,293 physicians]

Cost/quality Low quality Average quality High quality

High Cost ...... ¥4.0% (122 TINs; 4,051 physicians) ... ¥2.0% (261 TINs; 10,190 physicians) +0.0% (8 TINs; 285 physicians) * These TINs were eligible for an additional +1.0x for reporting measures and having an average beneficiary risk score in the top 25 percent of all beneficiary risk scores.

For physicians (149,498) that are in physicians in participant TINs in 382 adjustment based on performance Category 1 TINs that participated in a ACOs will receive a neutral payment compared to those in Category 1 non- Shared Savings Program ACO (12,500) adjustment; and physicians in ACO TINs. Physicians in ACOs are also in CY 2015, Table 58 shows the participant TINS with 10 or more EPs in more likely to get either an average or distribution of the 389 ACOs into the 4 ACOs will receive a downward upward adjustment under the VM various quality tiers along with the payment adjustment under the VM in compared to physicians overall. The VM number of physicians in the ACOs. The CY 2017. Physicians in ACO TINs are is applied at the TIN-level, and the results show that physicians in more likely to be in a Category 1 TIN amount of the upward or downward participant TINs in 3 ACOs will receive compared to those in non-ACO TINs adjustment will vary based on the size an upward payment adjustment; and are less likely to get the downward of the ACO’s participant TIN.

TABLE 58—PRELIMINARY DISTRIBUTION OF CATEGORY 1 SHARED SAVINGS PROGRAM ACOS (AND PHYSICIANS IN THE ACOS’ PARTICIPANT TINS) UNDER THE CY 2017 VM [389 ACOs; 149,498 physicians]

Cost/quality Low quality Average quality High quality

Low Cost ...... Does not apply ...... Does not apply ...... Does not apply. Average Cost ...... 4 ACOs ...... 382 ACOs ...... 3 ACOs. High Cost ...... Does not apply ...... Does not apply ...... Does not apply. * These TINs were eligible for an additional +1.0x for reporting measures and having an average beneficiary risk score in the top 25 percent of all beneficiary risk scores.

The numbers presented above are value compensation, and indirect than those shown in Table 52 (CY 2017 preliminary numbers and may be compensation arrangements. These PFS Estimated Impact on Total Allowed subject to change as a result of the provisions are necessary to protect Charges by Specialty). For example, the informal review process. In late 2016, against potential abuses such as estimated increases to primary care after the conclusion of the informal overutilization and stifling patient specialties would be lessened without review period, we will release updates choice. We believe that most parties the revised payment policies for certain to the number of TINs receiving comply with these regulatory provisions care management and patient-specific upward, neutral, and downward since they originally became effective services as described in section II.E. of adjustments, along with the adjustment on October 1, 2009, and the re-issued this final rule with comment period. factor for the CY 2017 VM on the CMS regulations text is identical to the However, because PFS rates are based Web site at https://www.cms.gov/ existing regulations text. Therefore, we on relative value units, the final rates Medicare/Medicare-Fee-for-Service- do not believe that the provisions will reflect all of the final changes and Payment/PhysicianFeedbackProgram/ have a significant burden. eliminate some of the proposed changes 2015-QRUR.html. We note that in the that might have multi-faceted impacts G. Alternatives Considered 2015 QRUR Experience Report, which on the payment rates for other services. we intend to release in early 2017, we This final rule contains a range of H. Impact on Beneficiaries will provide a detailed analysis of the policies, including some provisions impact of the 2017 VM policies on related to specific statutory provisions. There are a number of changes in this physicians in groups of 2 or more EPs The preceding preamble provides final rule that would have an effect on and physician solo practitioners subject descriptions of the statutory provisions beneficiaries. In general, we believe that to the VM in CY 2017, including that are addressed, identifies those many of these changes, including those findings based on the data contained in policies when discretion has been intended to improve accuracy in the 2015 Annual QRURs for all groups exercised, presents rationale for our payment through revisions to the inputs and solo practitioners. final policies and, where relevant, used to calculate payments under the alternatives that were considered. For PFS, would have a positive impact and 12. Physician Self-Referral Updates purposes of the payment impact on PFS improve the quality and value of care The physician self-referral update services of the policies contained in this provided to Medicare beneficiaries. In provisions are discussed in section III.M final rule, we presented the estimated particular, we believe that improving of this final rule. We re-issued impact on total allowed charges by payment for primary care and care regulatory provisions prohibiting certain specialty. The alternatives we management services based on more per-unit of service compensation considered, as discussed in the accurate assessment of patient needs formulas for determining rental charges preceding preamble sections, will result and the resources involved in caring for in the exceptions for the rental of office in different final payment rates, and them will benefit beneficiaries by space, rental of equipment, fair market therefore, result in different estimates improving care coordination and

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providing more effective treatment, TABLE 59—ACCOUNTING STATEMENT: diseases, Medicare, Reporting and particularly to those beneficiaries with CLASSIFICATION OF ESTIMATED EX- recordkeeping requirements. behavioral health conditions. PENDITURES 42 CFR Part 417 Most of the aforementioned final Category Transfers Administrative practice and policy changes could result in a change procedure, Grant programs-health, in beneficiary liability as relates to CY 2017 Annualized Estimated increase in Health care, Health insurance, Health coinsurance (which is 20 percent of the Monetized Trans- expenditures of maintenance organizations (HMO), Loan fee schedule amount, if applicable for fers $0.2 billion for PFS programs-health, Medicare, Reporting the particular provision after the CF update and recordkeeping requirements. beneficiary has met the deductible). To From Whom To Federal Government 42 CFR Part 422 illustrate this point, as shown in our Whom? to physicians, other public use file Impact on Payment for practitioners and Administrative practice and providers and sup- Selected Procedures available on the procedure, Health facilities, Health pliers who receive maintenance organizations (HMO), CMS Web site at http://www.cms.gov/ payment under Medicare/Medicare-Fee-for-Service- Medicare. Medicare, Penalties, Privacy, Reporting Payment/PhysicianFeeSched/, the CY and recordkeeping requirements. 2016 national payment amount in the 42 CFR Part 423 TABLE 60—ACCOUNTING STATEMENT: nonfacility setting for CPT code 99203 Administrative practice and (Office/outpatient visit, new) was CLASSIFICATION OF ESTIMATED COSTS, TRANSFER, AND SAVINGS procedure, Emergency medical services, $108.85, which means that in CY 2016, Health facilities, Health maintenance a beneficiary would be responsible for Category Transfer organizations (HMO), Medicare, 20 percent of this amount, or $21.77. Penalties, Privacy, Reporting and Based on this final rule, using the CY CY 2017 Annualized $0.0 billion. recordkeeping requirements. 2017 CF, the CY 2017 national payment Monetized Trans- 42 CFR Part 424 amount in the nonfacility setting for fers of beneficiary CPT code 99203, as shown in the Impact cost coinsurance Emergency medical services, Health on Payment for Selected Procedures From Whom to Federal Government facilities, Health professions, Medicare, Whom? to Beneficiaries. table, is $109.46, which means that, in Reporting and recordkeeping requirements. CY 2017, the final beneficiary J. Conclusion coinsurance for this service would be 42 CFR Part 425 $21.89. The analysis in the previous sections, Administrative practice and As discussed in section III.B of this together with the remainder of this procedure, Health facilities, Health final rule, we proposed that beginning preamble, provided an initial Regulatory professions, Medicare, Reporting and Flexibility Analysis. The previous on January 1, 2017, the FQHC base rate recordkeeping requirements. analysis, together with the preceding would be updated using a FQHC- portion of this preamble, provides a 42 CFR Part 460 specific market basket instead of using Regulatory Impact Analysis. In the MEI to more accurately reflect Aged, Health care, Health records, accordance with the provisions of Medicaid, Medicare, Reporting and changes in the cost of furnishing FQHC Executive Order 12866, this regulation recordkeeping requirements. services. This would result in a higher was reviewed by the Office of payment to FQHCs, and since For the reasons set forth in the Management and Budget. preamble, the Centers for Medicare & coinsurance is 20 percent of the lesser List of Subjects Medicaid Services amends 42 CFR of the FQHC’s charge for the specific chapter IV as set forth below: payment code or the PPS rate, 42 CFR Part 405 beneficiary coinsurance would also PART 405—FEDERAL HEALTH increase. The FQHC market basket cost Administrative practice and INSURANCE FOR THE AGED AND estimates in Table 53 include a procedure, Health facilities, Health DISABLED premium offset line which is the professions, Kidney diseases, Medical devices, Medicare, Reporting and ■ amount of cost that would be offset by 1. The authority citation for part 405 recordkeeping requirements, Rural the beneficiaries. The beneficiaries continues to read as follows: areas, X-rays. would pay approximately $5 million Authority: Secs. 205(a), 1102, 1861, and $35 million over the 5 and 10 year 42 CFR Part 410 1862(a), 1869, 1871, 1874, 1881, and 1886(k) projection windows. of the Social Security Act (42 U.S.C. 405(a), Health facilities, Health professions, 1302, 1395x, 1395y(a), 1395ff, 1395hh, I. Accounting Statement Kidney diseases, Laboratories, 1395kk, 1395rr and 1395ww(k)), and sec. 353 Medicare, Reporting and recordkeeping of the Public Health Service Act (42 U.S.C. As required by OMB Circular A–4 requirements, Rural areas, X-rays. 263a). (available at http:// ■ 2. Section 405.373 is amended by— 42 CFR Part 411 www.whitehouse.gov/omb/circulars/ ■ a. Revising paragraphs (a) a004/a-4.pdf), in Tables 59 and 60 Kidney diseases, Medicare, Physician introductory text and (b). ■ (Accounting Statements), we have Referral, Reporting and recordkeeping b. Adding paragraph (f). The revisions and addition read as prepared an accounting statement. This requirements. follows: estimate includes growth in incurred 42 CFR Part 414 benefits from CY 2016 to CY 2017 based § 405.373 Proceeding for offset or on the FY 2017 President’s Budget Administrative practice and recoupment. baseline. procedure, Biologics, Drugs, Health (a) General rule. Except as specified in facilities, Health professions, Kidney paragraphs (b) and (f) of this section, if

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the Medicare Administrative Contractor furnished by auxiliary personnel, as CDC-approved DPP curriculum refers or CMS has determined that an offset or defined in § 410.26(a)(1) of this chapter. to the content of the core sessions, core recoupment of payments under * * * * * maintenance sessions, and ongoing § 405.371(a)(3) should be put into effect, maintenance sessions. The curriculum the Medicare Administrative Contractor PART 410—SUPPLEMENTARY may be either the CDC-preferred must— MEDICAL INSURANCE (SMI) curriculum as designated by the CDC * * * * * BENEFITS DPRP Standards or an alternative (b) Exception to recouping payment. curriculum approved for use in DPP by ■ Paragraph (a) of this section does not 5. The authority citation for part 410 the CDC. apply if the Medicare Administrative continues to read as follows: Coach refers to an individual who Contractor, after furnishing a provider a Authority: Secs. 1102, 1834, 1871, 1881, furnishes MDPP services on behalf of an written notice of the amount of program and 1893 of the Social Security Act (42 MDPP supplier as an employee, reimbursement in accordance with U.S.C. 1302. 1395m, 1395hh, and 1395ddd). contractor, or volunteer. Core maintenance sessions refer to at § 405.1803, recoups payment under ■ 6. Section 410.26 is amended by— least 6 monthly sessions furnished over paragraph (c) of § 405.1803. (For ■ a. Redesignating paragraphs (a)(3) provider rights in this circumstance, see the MDPP core benefit’s months 6–12 through (7) as paragraphs (a)(4) through and furnished after the core sessions, §§ 405.1809, 405.1811, 405.1815, (8), respectively. 405.1835, and 405.1843.) regardless of weight loss. ■ b. Adding new paragraph (a)(3). Core sessions refer to at least 16 * * * * * ■ c. Revising paragraph (b)(5). weekly sessions that are furnished over (f) Exception to offset or recoupment The addition and revision reads as the MDPP core benefit’s months 1–6. of payments for shared Taxpayer follows: Diabetes Prevention Recognition Identification Number. Paragraph (a) of § 410.26 Services and supplies incident to Program (DPRP) refers to a program this section does not apply in instances administered by the Centers for Disease where the Medicare Administrative a physician’s professional services: Conditions. Control and Prevention (CDC) that Contractor intends to offset or recoup recognizes organizations that are able to payments to the applicable provider of (a) * * * (3) General supervision means the furnish diabetes prevention program services or supplier to satisfy an amount (DPP) services, follow a CDC-approved due from an obligated provider of service is furnished under the physician’s (or other practitioner’s) DPP curriculum, and meet CDC’s services or supplier when the applicable performance standards and reporting and obligated provider of services or overall direction and control, but the physician’s (or other practitioner’s) requirements. supplier share the same Taxpayer Evaluation weight refers to the Identification Number. presence is not required during the performance of the service. beneficiary’s body weight updated from ■ 3. Section 405.2413 is amended by the first core session and recorded revising paragraph (a)(5) to read as * * * * * before or during that beneficiary’s final follows: (b) * * * core session. (5) In general, services and supplies Full CDC DPRP recognition refers to § 405.2413 Services and supplies incident must be furnished under the direct the designation from the CDC that an to a physician’s services. supervision of the physician (or other organization has consistently furnished (a) * * * practitioner). Designated care CDC-approved DPP sessions, met CDC- (5) Furnished under the direct management services can be furnished performance standards and met CDC supervision of a physician, except that under general supervision of the reporting requirements for at least 24–36 services and supplies furnished incident physician (or other practitioner) when months following the organization’s to transitional care management and these services or supplies are provided application to participate in the DPRP. chronic care management services can incident to the services of a physician Maintenance of weight loss refers to be furnished under general supervision (or other practitioner). The physician (or achieving the required minimum weight of a physician when these services or other practitioner) supervising the loss from baseline weight at any point supplies are furnished by auxiliary auxiliary personnel need not be the during each 3-month core maintenance personnel, as defined in § 410.26(a)(1) of same physician (or other practitioner) or ongoing maintenance session bundle. this chapter. who is treating the patient more Maintenance session bundle refers to * * * * * broadly. However, only the supervising each 3-month interval of core ■ 4. Section 405.2415 is amended by physician (or other practitioner) may maintenance or ongoing maintenance revising paragraph (a)(5) to read as bill Medicare for incident to services. sessions. They must include at least one follows: * * * * * maintenance session furnished in each ■ 7. Section 410.79 is added to subpart of the 3 months, for a minimum of three § 405.2415 Incident to services and direct B to read as follows: sessions in each bundle. supervision. MDPP core benefit refers to a 12- (a) * * * § 410.79 Medicare diabetes prevention month intensive behavioral change (5) Furnished under the direct program expanded model: Conditions of program that applies a CDC-approved supervision of a nurse practitioner, coverage. curriculum. The core benefit consists of physician assistant, or certified nurse- (a) Medicare Diabetes Prevention at least 16 weekly core sessions over the midwife, except that services and Program (MDPP) services will be first 6 months and at least 6 monthly supplies furnished incident to available beginning on January 1, 2018. core maintenance sessions over the transitional care management and (b) Definitions. For purposes of this second 6 months, furnished regardless chronic care management services can section, the following definitions apply: of weight loss. be furnished under general supervision Baseline weight refers to the eligible MDPP eligible beneficiary refers to an of a nurse practitioner, physician beneficiary’s body weight recorded individual who satisfies the criteria assistant, or certified nurse-midwife, during that beneficiary’s first core defined in paragraph (c)(1) of this when these services or supplies are session. section.

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MDPP services refer to structural a week apart over a period of at least 16 (ii) Per-unit of service rental charges, health behavior change sessions with weeks to 26 weeks. At least one core to the extent that such charges reflect the goal of preventing diabetes among maintenance session must be furnished services provided to patients referred by individuals with pre-diabetes. MDPP in each of the second 6 months. All core the lessor to the lessee. services consist of core sessions, core sessions and core maintenance sessions * * * * * maintenance sessions, and ongoing must have a duration of approximately (p) * * * maintenance sessions that follow a CDC- one hour. MDPP suppliers must address (1) * * * approved curriculum. The sessions at least 16 different curriculum topics in (ii) * * * provide practical training in long-term the core sessions and at least 6 different (B) Per-unit of service rental charges, dietary change, increased physical curriculum topics in the core to the extent that such charges reflect activity, and problem-solving strategies maintenance sessions. services provided to patients referred by for overcoming challenges to (ii) Ongoing maintenance sessions. the lessor to the lessee. maintaining weight loss and a healthy MDPP suppliers must furnish each * * * * * ongoing maintenance session bundle lifestyle. ■ 10. Section 411.372 is amended by MDPP supplier refers to an entity that after the core benefit to MDPP eligible revising paragraph (a) to read as follows: has enrolled in Medicare, furnishes beneficiaries who have achieved MDPP services, and has either maintenance of weight loss during the § 411.372 Procedure for submitting a preliminary or full CDC DPRP previous maintenance session bundle. request. recognition. All ongoing maintenance sessions must (a) Format for a request. A party or Medicare Diabetes Prevention have a duration of approximately one parties must submit a request for an Program (MDPP) refers to an expanded hour. All curriculum topics may be advisory opinion to CMS according to model test under section 1115A(c) of the offered except for the introductory the instructions specified on the CMS Act that makes MDPP services available sessions. Web site. to MDPP eligible beneficiaries. (d) Limitations on coverage of MDPP * * * * * National Diabetes Prevention Program services. (1) The MDPP core benefit is (DPP) refers to an evidence-based available only once per lifetime per PART 414—PAYMENT FOR PART B intervention targeted to individuals MDPP eligible beneficiary. MEDICAL AND OTHER HEALTH with pre-diabetes that is furnished in (2) Ongoing maintenance sessions are SERVICES community and health care settings and available only if the MDPP eligible administered by the Centers for Disease beneficiary has achieved maintenance of ■ 11. The authority citation for part 414 Control and Prevention (CDC). weight loss. continues to read as follows: Ongoing maintenance sessions refer to monthly sessions furnished after the PART 411—EXCLUSIONS FROM Authority: Secs. 1102, 1871, and 1881(b)(l) 12-month core benefit has been MEDICARE AND LIMITATIONS ON of the Social Security Act (42 U.S.C. 1302, 1395hh, and 1395rr(b)(l)). completed and that teach a CDC- MEDICARE PAYMENT ■ approved curriculum. 12. Section 414.22 is amended by Required minimum weight loss refers ■ 8. The authority citation for part 411 revising paragraphs (b)(5) introductory to the percentage by which the continues to read as follows: text and (b)(5)(i)(A) and (B) to read as beneficiary’s evaluation weight is less Authority: Secs. 1102, 1860D–1 through follows: than the baseline weight. The required 1860D–42, 1871, and 1877 of the Social § 414.22 Relative value units (RVUs). minimum weight loss percentage is 5 Security Act (42 U.S.C. 1302, 1395w-101 * * * * * percent. through 1395w-152, 1395hh, and 1395nn). (b) * * * (c) Program requirements—(1) ■ 9. Section 411.357 is amended by (5) For services furnished in 2002 and Beneficiary eligibility. Medicare revising paragraphs (a)(5)(ii)(B), subsequent years, the practice expense beneficiaries are eligible for MDPP (b)(4)(ii)(B), (l)(3)(ii), and (p)(1)(ii)(B) to RVUs are based entirely on relative services if they meet all of the following read as follows: practice expense resources. criteria: (i) Are enrolled in Medicare Part B. § 411.357 Exceptions to the referral (i) * * * (ii) Have as of the date of attendance prohibition related to compensation (A) Facility practice expense RVUs. at the first core session a body mass arrangements. The facility practice expense RVUs index (BMI) of at least 25 if not self- * * * * * apply to services furnished to patients identified as Asian and a BMI of at least (a) * * * in a hospital, a skilled nursing facility, 23 if self-identified as Asian. (5) * * * a community mental health center, a (iii) Have, within the 12 months prior (ii) * * * hospice, or an ambulatory surgical to attending the first core session, a (B) Per-unit of service rental charges, center, or in a wholly owned or wholly hemoglobin A1c test with a value to the extent that such charges reflect operated entity providing preadmission between 5.7 and 6.4 percent, a fasting services provided to patients referred by services under § 412.2(c)(5) of this plasma glucose of 110–125 mg/dL, or a the lessor to the lessee. chapter, or via telehealth under § 410.78 2-hour plasma glucose of 140–199 mg/ * * * * * of this chapter. dL (oral glucose tolerance test). (b) * * * (B) Nonfacility practice expense (iv) Have no previous diagnosis of (4) * * * RVUs. The nonfacility practice expense type 1 or type 2 diabetes. (ii) * * * RVUs apply to services furnished to (v) Do not have end-stage renal (B) Per-unit of service rental charges, patients in all locations other than those disease (ESRD). to the extent that such charges reflect listed in paragraph (b)(5)(i)(A) of this (2) MDPP services—(i) Core sessions services provided to patients referred by section, but not limited to, a physician’s and core maintenance sessions. MDPP the lessor to the lessee. office, the patient’s home, a nursing suppliers must furnish to MDPP * * * * * facility, or a comprehensive outpatient beneficiaries the MDPP core benefit. 16 (l) * * * rehabilitation facility (CORF). core sessions must be furnished at least (3) * * * * * * * *

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§ 414.32 [Removed] (b) * * * (iv) Be able to incorporate specified ■ 13. Section 414.32 is removed. Applicable payment system means the applicable AUC from more than one ■ 14. Section 414.90 is amended by following: qualified PLE. adding paragraphs (j)(1)(ii), (j)(4)(v), (i) The physician fee schedule (v) Determines, for each consultation, (j)(7)(viii) and (k)(4)(ii) to read as established under section 1848(b) of the the extent to which the applicable follows: Act; imaging service is consistent with (ii) The prospective payment system specified applicable AUC. § 414.90 Physician Quality Reporting for hospital outpatient department (vi) Generate and provide a System (PQRS). services under section 1833(t) of the certification or documentation at the * * * * * Act; and time of order that documents which (j) * * * (iii) The ambulatory surgical center qualified CDSM was consulted; the (1) * * * payment systems under section 1833(i) name and national provider identifier (ii) Secondary Reporting Period for of the Act. (NPI) of the ordering professional that the 2017 PQRS payment adjustment for * * * * * consulted the CDSM; whether the certain eligible professionals or group Clinical decision support mechanism service ordered would adhere to practices– Individual eligible (CDSM) means the following: an specified applicable AUC; whether the professionals or group practices, who interactive, electronic tool for use by service ordered would not adhere to bill under the TIN of an ACO clinicians that communicates AUC specified applicable AUC; or whether participant if the ACO failed to report information to the user and assists them the specified applicable AUC consulted data on behalf of such EPs or group in making the most appropriate was not applicable to the service practices during the previously treatment decision for a patient’s ordered. Certification or documentation established reporting period for the specific clinical condition. Tools may be must: 2017 PQRS payment adjustment, may modules within or available through (A) Be generated each time an separately report during a secondary certified EHR technology (as defined in ordering professional consults a reporting period for the 2017 PQRS section 1848(o)(4)) of the Act or private qualified CDSM. payment adjustment. The secondary sector mechanisms independent from (B) Include a unique consultation reporting period for the 2017 PQRS certified EHR technology or established identifier generated by the CDSM. payment adjustment for the affected by the Secretary. (vii) Modifications to AUC within the individual eligible professionals or CDSM must comply with the following group practices is January 1, 2016 * * * * * timeline requirements: through December 31, 2016. (e) * * * (A) Make available updated AUC (5) Priority clinical areas include the * * * * * content within 12 months from the date (4) * * * following: the qualified PLE updates AUC. (v) Paragraphs (j)(8)(ii), (iii), and (iv) (i) Coronary artery disease (suspected (B) A protocol must be in place to of this section apply to individuals or diagnosed). expeditiously remove AUC determined reporting using the secondary reporting (ii) Suspected pulmonary embolism. by the qualified PLE to be potentially period established under paragraph (iii) Headache (traumatic and non- dangerous to patients and/or harmful if (j)(1)(ii) of this section for the 2017 traumatic). followed. PQRS payment adjustment. (iv) Hip pain. (C) Specified applicable AUC that (v) Low back pain. reasonably address common and * * * * * (vi) Shoulder pain (to include (7) * * * important clinical scenarios within any (viii) Paragraphs (j)(9)(ii), (iii), and (iv) suspected rotator cuff injury). new priority clinical area must be made of this section apply to group practices (vii) Cancer of the lung (primary or available for consultation through the reporting using the secondary reporting metastatic, suspected or diagnosed). qualified CDSM within 12 months of the period established under paragraph (viii) Cervical or neck pain. priority clinical area being finalized by (j)(1)(ii) of this section for the 2017 * * * * * CMS. PQRS payment adjustment. (g) Qualified clinical decision support (viii) Meet privacy and security * * * * * mechanisms (CDSMs). Qualified CDSMs standards under applicable provisions (k) * * * are those specified as such by CMS. of law. (4) * * * Qualified CDSMs must adhere to the (ix) Provide to the ordering (ii) Section 414.90(k)(5) applies to requirements described in paragraph professional aggregate feedback individuals and group practices (g)(1) of this section. regarding their consultations with reporting using the secondary reporting (1) Requirements for qualification of specified applicable AUC in the form of period established under paragraph CDSMs. A CDSM must meet all of the an electronic report on at least an (j)(1)(ii) of this section for the 2017 following requirements: annual basis. PQRS payment adjustment. (i) Make available specified applicable (x) Maintain electronic storage of * * * * * AUC and its related supporting clinical, administrative, and ■ documentation. demographic information of each 15. Section 414.94 is amended by— (ii) Identify the appropriate use ■ a. Amending paragraph (b) to add the unique consultation for a minimum of 6 criterion consulted if the CDSM makes definitions of ‘‘Applicable payment years. available more than one criterion system’’ and ‘‘Clinical decision support (xi) Comply with modification(s) to relevant to a consultation for a patient’s mechanism’’ in alphabetical order. any requirements under paragraph (g)(1) ■ b. Adding paragraphs (e)(5), (g), (h), specific clinical scenario. of this section made through rulemaking and (i). (iii) Make available, at a minimum, within 12 months of the effective date The additions read as follows: specified applicable AUC that of the modification. reasonably address common and (xii) Notify ordering professionals § 414.94 Appropriate use criteria for important clinical scenarios within all upon de-qualification. advanced diagnostic imaging services. priority clinical areas identified in (2) Process to specify qualified * * * * * paragraph (e)(5) of this section. CDSMs. (i) The CDSM developer must

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submit an application to CMS for review medical conditions as defined in section for groups of physicians with 10 or more that documents adherence to each of the 1867(e)(1) of the Act. eligible professionals and equal to –2% CDSM requirements outlined in (2) For an inpatient and for which for groups of physicians with two to paragraph (g)(1) of this section; payment is made under Medicare Part nine eligible professionals and for (ii) Receipt of applications. (A) A. physician solo practitioners. If the ACO Applications must be received by CMS (3) Ordering professionals who are has an assigned beneficiary population annually by January 1 (except as stated granted a significant hardship exception during the performance period with an in paragraph (g)(2)(ii)(B) of this section). to the Medicare EHR Incentive Program average risk score in the top 25 percent (B) For CDSM applicants seeking payment adjustment for that year under of the risk scores of beneficiaries qualification in CY 2017, applications § 495.102(d)(4) of this chapter, except nationwide, and a group of physician or must be submitted by March 1, 2017; for those granted such an exception physician solo practitioner that and under § 495.102(d)(4)(iv)(C) of this participates in the ACO during the (1) Applications that document chapter. performance period is classified as high current adherence to qualified CDSM ■ 16. Section 414.1210 is amended by quality/average cost under quality- requirements will receive full revising paragraphs (b)(2)(i)(B), (C), (D), tiering for the CY 2017 payment qualification. and (F) to read as follows: adjustment period, the group or solo (2) Applications that do not document practitioner receives an upward current adherence to each qualified § 414.1210 Application of the value-based × × payment modifier. adjustment of +3 (rather than +2 ) if CDSM requirement, but that document the group has 10 or more eligible how and when each requirement is * * * * * professionals or +2 × (rather than +1 ×) (b) * * * reasonably expected to be met, will for a solo practitioner or the group has receive preliminary qualification. (2) * * * (i) * * * two to nine eligible professionals. (3) A preliminary qualification period (D) For the CY 2018 payment begins under paragraph (2) on June 30, (B) For groups and solo practitioners that participate in a Shared Savings adjustment period, the value-based 2017 and ends on the effective date of payment modifier adjustment will be the requirements under sections Program ACO that successfully reports quality data as required by the Shared equal to the amount determined under 1834(q)(4)(A) and 1834(q)(4)(B) of the § 414.1275 for the payment adjustment Act. Savings Program under § 425.504 of this chapter, the quality composite score is period, except that if the ACO (or (4) A CDSM with preliminary groups and solo practitioners that qualification will become fully qualified calculated under § 414.1260(a) using quality data reported by the ACO for the participate in the ACO) does not by the end of the preliminary successfully report quality data as qualification period, or earlier if CMS performance period through the ACO GPRO Web interface as required under described in paragraph (b)(2)(i)(B) of determines that the CDSM has this section for the performance period, demonstrated adherence to each § 425.504(a)(1) of this chapter or another mechanism specified by CMS and the such adjustment will be equal to the qualified CDSM requirement, unless we downward payment adjustment determine that the CDSM fails to meet ACO all-cause readmission measure. Groups and solo practitioners that amounts described at § 414.1270(d)(1). If all requirements (including those the ACO has an assigned beneficiary requirements they expected to meet in participate in two or more ACOs during the applicable performance period population during the performance paragraph (g)(2)(ii)(B)(2) of this section) period with an average risk score in the by the end of the preliminary receive the quality composite score of the ACO that has the highest numerical top 25 percent of the risk scores of qualification period. beneficiaries nationwide, and a group or (iii) All qualified CDSMs specified by quality composite score. For the CY solo practitioner that participates in the CMS in each year will be included on 2018 payment adjustment period, the ACO during the performance period is the list of specified qualified CDSMs CAHPS for ACOs survey also will be classified as high quality/average cost posted to the CMS Web site by June 30 included in the quality composite score. under quality-tiering for the CY 2018 of that year; and For the CY 2017 and 2018 payment (iv) Qualified CDSMs are specified by adjustment periods, for groups and solo payment adjustment period, the group practitioners who participate in a or solo practitioner receives an upward CMS as such for a period of 5 years. × × (v) Qualified CDSMs are required to Shared Savings Program ACO that does adjustment of +3 (rather than +2 ) if not successfully report quality data as the group of physicians has 10 or more re-apply during the fifth year after they × required by the Shared Savings Program eligible professionals, +2 (rather than are specified by CMS in order to × maintain their status as qualified under § 425.504 and who meet the +1 ) for a physician solo practitioner or requirements to avoid the PQRS if the group of physicians has two to CDSMs. This application must be × payment adjustment for CY 2018 by nine eligible professionals, or +2 received by CMS by January 1 of the 5th × year after the most recent approval date. reporting to the PQRS outside the ACO, (rather than +1 ) for a solo practitioner (h) Identification of non-adherence to the quality composite is classified as who is a nonphysician eligible requirements for qualified CDSMs. (1) If ‘‘average’’ under § 414.1275(b). professional or if the group consists of a qualified CDSM is found non-adherent (C) For the CY 2017 payment nonphysician eligible professionals. to the requirements in paragraph (g)(1) adjustment period, the value-based * * * * * of this section, CMS may terminate its payment modifier adjustment will be (F) For groups and solo practitioners qualified status or may consider this equal to the amount determined under that participate in a Shared Savings information during requalification. § 414.1275 for the payment adjustment Program ACO that successfully reports (i) Exceptions. Consulting and period, except that if the ACO (or quality data as required by the Shared reporting requirements are not required groups and solo practitioners that Savings Program under § 425.504 of this for orders for applicable imaging participate in the ACO) does not chapter, the same value-based payment services made by ordering professionals successfully report quality data as modifier adjustment will be applied in under the following circumstances: described in paragraph (b)(2)(i)(B) of the payment adjustment period to all (1) Emergency services when this section for the performance period, groups based on size as specified under provided to individuals with emergency such adjustment will be equal to –4% § 414.1275 and solo practitioners that

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participated in the ACO during the ■ 22. Section 422.204 is amended by program, the MA organization must performance period. adding paragraph (b)(5) to read as notify the enrollee and the excluded or * * * * * follows: revoked individual or entity in writing, as directed by contract or other PART 417—HEALTH MAINTENANCE § 422.204 Provider selection and direction provided by CMS, that credentialing. ORGANIZATIONS, COMPETITIVE payments will not be made. Payment MEDICAL PLANS, AND HEALTH CARE * * * * * may not be made to, or on behalf of, an PREPAYMENT PLANS (b) * * * individual or entity that is excluded by (5) Ensures compliance with the the OIG or is revoked in the Medicare ■ 17. The authority citation for part 417 provider and supplier enrollment program. requirements at § 422.222. continues to read as follows: ■ 25. Section 422.250 is revised to read ■ Authority: Secs. 1102 and 1871 of the 23. Section 422.222 is added to as follows: Social Security Act (42 U.S.C. 1302 and subpart E to read as follows: 1395hh), secs. 1301, 1306, and 1310 of the § 422.250 Basis and scope. § 422.222 Enrollment of MA organization Public Health Service Act (42 U.S.C. 300e, network providers and suppliers; first-tier, This subpart is based largely on 300e–5, and 300e–9), and 31 U.S.C. 9701. downstream, and related entities (FDRs); section 1854 of the Act, but also ■ 18. Section 417.478 is amended by cost HMO or CMP, and demonstration and includes provisions from sections 1853 adding paragraph (e) to read as follows: pilot programs. and 1858 of the Act, and is also based (a) Providers or suppliers that are on section 1106 of the Act. It sets forth § 417.478 Requirements of other laws and types of individuals or entities that can the requirements for the Medicare regulations. enroll in Medicare in accordance with Advantage bidding payment * * * * * section 1861 of the Act, must be methodology, including CMS’ (e) Sections 422.222 and 422.224 of enrolled in Medicare and be in an calculation of benchmarks, submission this chapter which requires all approved status in Medicare in order to of plan bids by Medicare Advantage providers or suppliers that are types of provide health care items or services to (MA) organizations, establishment of individuals or entities that can enroll in a Medicare enrollee who receives his or beneficiary premiums and rebates Medicare in accordance with section her Medicare benefit through an MA through comparison of plan bids and 1861 of the Act, to be enrolled in organization. This requirement applies benchmarks, negotiation and approval Medicare in an approved status and to all of the following providers and of bids by CMS, and the release of MA prohibits payment to providers and suppliers: bid submission data. suppliers that are excluded or revoked. (1) Network providers and suppliers. ■ 26. Section 422.272 is added to This includes locum tenens suppliers (2) First-tier, downstream, and related subpart F to read as follows: and, if applicable, incident-to suppliers. entities (FDR). § 422.272 Release of MA bid pricing data. ■ 19. Section 417.484 is amended by (3) Providers and suppliers in Cost adding paragraph (b)(3) to read as HMOs or CMPs, as defined in 42 CFR (a) Terminology. For purposes of this follows: part 417. section, the term ‘‘MA bid pricing data’’ (4) Providers and suppliers means the following information that § 417.484 Requirement applicable to participating in demonstration MA organizations must submit for each related entities. programs. MA plan bid for the annual bid * * * * * (5) Providers and suppliers in pilot submission: (b) * * * programs. (1) The pricing-related information (3) All providers or suppliers that are (6) Locum tenens suppliers. described at § 422.254(a)(1); and types of individuals or entities that can (7) Incident-to suppliers. (2) The information required for MSA enroll in Medicare in accordance with (b) MA organizations that do not plans, described at § 422.254(e). section 1861 of the Act, are enrolled in ensure that providers and suppliers (b) Release of MA bid pricing data. Medicare in an approved status. comply with paragraph (a) of this Subject to paragraph (c) of this section section, may be subject to sanctions and to the annual timing identified in PART 422—MEDICARE ADVANTAGE under § 422.750 and termination under paragraph (d) of this section, CMS will PROGRAM § 422.510. release to the public MA bid pricing ■ 24. Section 422.224 is added to data for MA plan bids accepted or ■ 20. The authority citation for part 422 subpart E to read as follows: approved by CMS for a contract year continues to read as follows: under § 422.256. The annual release will § 422.224 Payment to providers or Authority: Secs. 1102 and 1871 of the contain MA bid pricing data from the suppliers excluded or revoked. Social Security Act (42 U.S.C. 1302 and final list of MA plan bids accepted or 1395hh). (a) An MA organization may not pay, approved by CMS for a contract year directly or indirectly, on any basis, for that is at least 5 years prior to the ■ 21. Section 422.1 is amended by items or services (other than emergency upcoming calendar year. redesignating paragraphs (a)(1)(i) and urgently needed services as defined (c) Exclusions from release of MA bid through (x) as paragraphs (a)(1)(ii) in § 422.113) furnished to a Medicare pricing data. For the purpose of this through (xi) and adding new paragraph enrollee by any individual or entity that section, the following information is (a)(1)(i) to read as follows: is excluded by the Office of the excluded from the data released under § 422.1 Basis and scope. Inspector General (OIG) or is revoked paragraph (b) of this section: from the Medicare program except as (1) For an MA plan bid that includes (a) * * * provided. Part D benefits, the information (1) * * * (b) If an MA organization receives a described at § 422.254(b)(1)(ii), (c)(3)(ii), (i) 1106—Disclosure of information in request for payment by, or on behalf of, and (c)(7). possession of agency. an individual or entity that is excluded (2) Additional information that CMS * * * * * by the OIG or is revoked in the Medicare requires to verify the actuarial bases of

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the bids for MA plans for the annual bid in Medicare in an approved status § 422.2400 Basis and scope. submission, as follows: consistent with § 422.222. This subpart is based on sections (i) Narrative information on base * * * * * 1857(e)(4), 1860D–12(b)(3)(D), and 1106 period factors, manual rates, cost- (n) Acknowledgements of CMS release of the Act, and sets forth medical loss sharing methodology, optional of data—(1) Summary CMS payment ratio requirements for Medicare supplement benefits, and other required data. The contract must provide that the Advantage organizations, financial narratives. MA organization acknowledges that penalties and sanctions against MA (ii) Supporting documentation. CMS releases to the public summary organizations when minimum medical (3) Any information that could be reconciled CMS payment data after the loss ratios are not achieved by MA used to identify Medicare beneficiaries reconciliation of Part C and Part D organizations, and release of medical or other individuals. payments for the contract year as loss ratio data to entities outside of (4) Bid review correspondence and follows: CMS. reports. (i) For Part C, the following data— ■ 32. Section 422.2490 is added to (d) Timing of data release. CMS will (A) Average per member per month subpart X to read as follows: release MA bid pricing data as provided CMS payment amount for A/B (original in paragraph (b) of this section on an Medicare) benefits for each MA plan § 422.2490 Release of Part C MLR data. annual basis after the first Monday in offered, standardized to the 1.0 (average (a) Terminology. Subject to the October. risk score) beneficiary. exclusions in paragraph (b) of this ■ 27. Section 422.501 is amended by (B) Average per member per month section, Part C MLR data consists of the adding paragraph (c)(1)(iv) and revising CMS rebate payment amount for each information contained in reports paragraph (c)(2) to read as follows: MA plan offered (or, in the case of MSA submitted under § 422.2460. (b) Exclusions from Part C MLR data. § 422.501 Application requirements. plans, the monthly MSA deposit amount). For the purpose of this section, the * * * * * (C) Average Part C risk score for each following items are excluded from Part (c) * * * MA plan offered. C MLR data: (1) * * * (D) County level average per member (1) Narrative descriptions that MA (iv) Documentation that all providers per month CMS payment amount for organizations submit to support the or suppliers in the MA or MA–PD plan each plan type in that county, weighted information reported to CMS pursuant that are types of individuals or entities by enrollment and standardized to the to the reporting requirements at that can enroll in Medicare in 1.0 (average risk score) beneficiary in § 422.2460, such as descriptions of accordance with section 1861 of the Act, that county. expense allocation methods. are enrolled in an approved status. (ii) For Part D plan sponsors, plan (2) Information that is reported at the (2) The authorized individual must payment data in accordance with plan level, such as the number of thoroughly describe how the entity and § 423.505(o) of this subchapter. member months associated with each MA plan meet, or will meet, all the (2) MA bid pricing data and Part C plan under a contract, including requirements described in this part, MLR data. The contract must provide information submitted for a contract including providing documentation that that the MA organization acknowledges consisting of only one plan. all providers and suppliers referenced that CMS releases to the public data as (3) Any information that could be in § 422.222 are enrolled in Medicare in described at §§ 422.272 and 422.2490. used to identify Medicare beneficiaries an approved status. * * * * * or other individuals. * * * * * ■ (4) MLR review correspondence. ■ 29. Section 422.510 is amended by 28. Section 422.504 is amended by— adding paragraph (a)(4)(xiii) to read as (5) Any information for a contract for ■ a. Revising paragraph (a)(6). follows: those contract years for which the ■ b. Adding paragraph (i)(2)(v). contract is determined to be non- ■ c. Revising paragraph (n). § 422.510 Termination of contract by CMS. credible, as defined in accordance with The revisions and addition read as (a) * * * § 422.2440(d). follows: (4) * * * (c) Data release. CMS releases to the § 422.504 Contract provisions. (xiii) Fails to meet provider and public Part C MLR data, for each supplier enrollment requirements in contract for each contract year, no * * * * * earlier than 18 months after the end of (a) * * * accordance with §§ 422.222 and the applicable contract year. (6) To comply with all applicable 422.224. provider and supplier requirements in * * * * * PART 423—VOLUNTARY MEDICARE subpart E of this part, including ■ 30. Section 422.752 is amended by PRESCRIPTION DRUG BENEFIT provider certification requirements, adding paragraph (a)(13) to read as anti-discrimination requirements, follows: ■ 33. The authority citation for part 423 provider participation and consultation continues to read as follows: requirements, the prohibition on § 422.752 Basis for imposing intermediate sanctions and civil money penalties. Authority: Sections 1102, 1106, 1860D–1 interference with provider advice, limits (a) * * * through 1860D–42, and 1871 of the Social on provider indemnification, rules Security Act (42 U.S.C. 1302, 1306, 1395w– governing payments to providers, limits (13) Fails to comply with §§ 422.222 101 through 1395w–152, and 1395hh). and 422.224, that requires the MA on physician incentive plans, and ■ organization to ensure providers and 34. Section 423.505 is amended by Medicare provider and supplier revising paragraph (o) to read as follows: enrollment requirements. suppliers are enrolled in Medicare and not make payment to excluded or * * * * * § 423.505 Contract provisions. revoked individuals or entities. (i) * * * * * * * * (2) * * * * * * * * (o) Acknowledgements of CMS release (v) They will require all of their ■ 31. Section 422.2400 is revised to read of data—(1) Summary CMS payment providers and suppliers to be enrolled as follows: data. The contract must provide that the

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Part D sponsor acknowledges that CMS (3) Any information that could be (2) MDPP suppliers are required to releases to the public summary used to identify Medicare beneficiaries maintain and handle any beneficiary PII reconciled Part D payment data after the or other individuals. and PHI in compliance with HIPAA, reconciliation of Part D payments for the (4) MLR review correspondence. other applicable privacy laws and CMS contract year as follows: (5) Any information for a contract for standards. (i) The average per member per month those contract years for which the (3) The MDPP supplier must maintain Part D direct subsidy standardized to contract is determined to be non- a crosswalk between the beneficiary the 1.0 (average risk score) beneficiary credible, as defined in accordance with identifiers submitted to CMS for billing for each Part D plan offered. § 423.2440(d). and the beneficiary identifiers (ii) The average Part D risk score for (c) Data release. CMS releases to the submitted to CDC for beneficiary level- public Part D MLR data, for each each Part D plan offered. clinical data. contract for each contract year, no (iii) The average per member per (4) The records must include an month Part D plan low-income cost earlier than 18 months after the end of the applicable contract year. attestation from the supplier that the sharing subsidy for each Part D plan MDPP eligible beneficiary for which it offered. PART 424—CONDITIONS FOR is submitting a claim: (iv) The average per member per MEDICARE PAYMENT (i) Has attended 1, 4 or 9 core month Part D Federal reinsurance sessions, or subsidy for each Part D plan offered. ■ 37. The authority citation for part 424 (v) The actual Part D reconciliation (ii) Has achieved the required continues to read as follows: minimum weight loss percentage payment data summarized at the Parent Authority: Secs. 1102 and 1871 of the Organization level including breakouts specified in § 410.79 of this chapter, or Social Security Act (42 U.S.C. 1302 and (iii) Has achieved maintenance of of risk sharing, reinsurance, and low 1395hh). income cost sharing reconciliation weight loss and attended core ■ 38. Section 424.59 is added to subpart amounts. maintenance sessions, or D to read as follows: (2) Part D MLR data. The contract (iv) Has achieved maintenance of must provide that the Part D sponsor § 424.59 Requirements for Medicare weight loss and attended ongoing acknowledges that CMS releases to the diabetes prevention program suppliers. maintenance sessions. public data as described at § 423.2490. (a) Conditions for enrollment. An (c) Conditions for payment of claims * * * * * entity may enroll as an MDPP supplier for MDPP services furnished. An MDPP ■ 35. Section 423.2400 is revised to read if it satisfies all of the following criteria supplier must meet all of the following as follows: and meets all other applicable Medicare requirements in order to receive enrollment requirements: payment for claims made for MDPP § 423.2400 Basis and scope. (1) At the time of enrollment has services furnished: This subpart is based on sections either preliminary or full CDC DPRP (1) Establishes and maintains all 1857(e)(4), 1860D–12(b)(3)(D), and 1106 recognition. enrollment and program requirements of the Act, and sets forth medical loss (2) Has obtained and maintains an under Title 42. ratio requirements for Part D sponsors, active and valid TIN and NPI at the (2) Submits attestation as specified in financial penalties and sanctions against organizational level. paragraph (b) of this section. (3) Has passed application screening Part D sponsors when minimum (d) Revocation of MDPP supplier medical loss ratios are not achieved by at a high categorical risk level per § 424.518(c). enrollment. An MDPP supplier is Part D sponsors and release of medical (4) All coaches who will be furnishing subject to revocation of its MDPP loss ratio data to entities outside of MDPP services on the entity’s behalf supplier enrollment if: CMS. have obtained and maintain active and (1) It loses its CDC DPRP recognition ■ 36. Section 423.2490 is added to valid NPIs. or withdraws from seeking CDC DPRP subpart X to read as follows: (5) Submits a roster of all coaches recognition. § 423.2490 Release of Part D MLR data. who will be furnishing MDPP services (2) One of the revocation reasons on the entity’s behalf that includes the specified in § 424.535 applies. (a) Terminology. Subject to the coaches’ first and last names, date of (e) Procedures for revoking or denying exclusions in paragraph (b) of this birth, SSN, and NPI. section, Part D MLR data consists of the MDPP supplier enrollment. (1) MDPP (b) Documentation retention and suppliers are subject to the enrollment information contained in reports provision requirements. An MDPP submitted under § 423.2460. regulations set forth in subpart P of this supplier must maintain all part. (b) Exclusions from Part D MLR data. documentation in accordance with (2) An MDPP supplier that has had its For the purpose of this section, the § 424.516(f) and all other federal and following items are excluded from Part state laws. The MDPP supplier must MDPP supplier enrollment revoked D MLR data: submit any documentation requested by may: (1) Narrative descriptions that Part D the government or a contractor to (i) Become eligible to bill for MDPP sponsors submit to support the substantiate the attestations or claims services again if it reapplies for CDC information reported to CMS pursuant submitted for payment under the DPRP recognition, successfully achieves to the reporting requirements at Medicare program. preliminary CDC DPRP recognition, and § 423.2460, such as descriptions of (1) The records must contain enrolls again Medicare as an MDPP expense allocation methods. documentation of the services furnished supplier subject to paragraph (a) of this (2) Information that is reported at the including evidence of the beneficiary’s section. plan level, such as the number of eligibility, specific session topics (ii) Appeal in accordance with the member months associated with each attended, the NPI of the coach who procedures specified in 42 CFR part plan under a contract, including furnished the session attended, the date 405, subpart H, 42 CFR part 424, and 42 information submitted for a contract and place of service of sessions CFR part 498. References to suppliers in consisting of only one plan. attended, and weight. these sections apply to MDPP suppliers.

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PART 425—MEDICARE SHARED more domains and may be subject to a (iii) The beneficiary must have SAVINGS PROGRAM CAP. CMS may forgo the issuance’’. designated an ACO professional who is ■ b. In paragraph (c)(2) by removing the a primary care physician as defined at ■ 39. AUTHORITY: Secs. 1102, 1106, 1871, phrase ‘‘quality performance standards’’ § 425.20, a physician with a specialty and 1899 of the Social Security Act (42 and adding in its place the phrase designation included at paragraph (c) of U.S.C. 1302, 1306, 1395hh, and 1395jjj). ‘‘quality performance standard’’. this section, or a nurse practitioner, ■ 40. Section 425.110 is amended by ■ 43. Section 425.402 is amended by— physician assistant, or clinical nurse revising paragraph (b)(1) to read as ■ a. In paragraph (b) introductory text, specialist as responsible for follows: removing the phrase ‘‘beneficiaries to an coordinating their overall care. ACO:’’ and adding in its place the § 425.110 Number of ACO professionals (iv) If a beneficiary has designated a phrase ‘‘beneficiaries to an ACO based provider or supplier outside the ACO and beneficiaries. on available claims information:’’ who is a primary care physician as * * * * * ■ b. Adding paragraph (e). (b) * * * The addition reads as follows: defined at § 425.20, a physician with a (1) While under the CAP, the ACO specialty designation included at § 425.402 Basic assignment methodology. remains eligible for shared savings and paragraph (c) of this section, or a nurse losses. * * * * * practitioner, physician assistant, or (i) For ACOs with a variable MSR and (e) For performance year 2018 and clinical nurse specialist, as responsible MLR (if applicable), the MSR and MLR subsequent performance years, if a for coordinating their overall care, the (if applicable) will be set at a level system is available to allow a beneficiary will not be added to the consistent with the number of assigned beneficiary to designate a provider or ACO’s list of assigned beneficiaries for beneficiaries. supplier as responsible for coordinating a performance year under the (ii) For ACOs with a fixed MSR/MLR, their overall care and for CMS to assignment methodology in paragraph the MSR/MLR will remain fixed at the process the designation electronically, (b) of this section. level consistent with the choice of MSR CMS will supplement the claims-based (3) The ACO, ACO participants, ACO and MLR that the ACO made at the start assignment methodology described in providers/suppliers, ACO professionals, of the agreement period. this section with information provided and other individuals or entities by beneficiaries regarding the provider * * * * * performing functions and services or supplier they consider responsible for related to ACO activities are prohibited § 425.204 [Amended] coordinating their overall care. Such from providing or offering gifts or other designations must be made in the form ■ remuneration to Medicare beneficiaries 41. § 425.204 is amended by— and manner and by a deadline ■ a. Amending paragraph (g) heading to as inducements for influencing a determined by CMS. Medicare beneficiary’s decision to remove the phrase ‘‘and acquired (1) Notwithstanding the assignment designate or not to designate an ACO Medicare-enrolled TINs’’ and adding in methodology under paragraph (b) of this professional under paragraph (e) of this its place the phrase ‘‘and acquired section, beneficiaries who designate an section. The ACO, ACO participants, entities’ TINs’’. ACO professional participating in an ■ ACO providers/suppliers, ACO b. Amending paragraph (g) ACO as responsible for coordinating professionals, and other individuals or introductory text to remove the phrase their overall care are prospectively entities performing functions and ‘‘claims billed by Medicare-enrolled assigned to that ACO, regardless of services related to ACO activities must entities’ TINs that’’ and adding in its track, annually at the beginning of each place the phrase ‘‘claims billed under benchmark and performance year based not, directly or indirectly, commit any the TINs of entities that’’. on available data at the time assignment act or omission, nor adopt any policy ■ c. Amending paragraph (g)(1) lists are determined for the benchmark that coerces or otherwise influences a introductory text to remove the phrase and performance year. Medicare beneficiary’s decision to ‘‘an acquired Medicare-enrolled entity’s (2) Beneficiaries will be added to the designate or not to designate an ACO TIN’’ and adding in its place the phrase ACO’s list of assigned beneficiaries if all professional as responsible for ‘‘an acquired entity’s TIN’’. of the following conditions are satisfied: coordinating their overall care under ■ d. Amending paragraph (g)(1)(i) to (i) The beneficiary must have had at paragraph (e) of this section, including remove the phrase ‘‘the acquired entity’s least one primary care service during but not limited to the following: Medicare-enrolled TIN’’ and adding in the assignment window as defined (i) Offering anything of value to the its place the phrase ‘‘the acquired under § 425.20 with a physician who is Medicare beneficiary as an inducement entity’s TIN’’ an ACO professional in the ACO who is to influence the Medicare beneficiary’s ■ e. Amending paragraph (g)(2)(i)(A) to a primary care physician as defined decision to designate or not to designate remove the phrase ‘‘Identifies by under § 425.20 or who has one of the an ACO professional as responsible for Medicare-enrolled TIN’’ and adding in primary specialty designations included coordinating their overall care under its place the phrase ‘‘Identifies by TIN’’. in paragraph (c) of this section. paragraph (e) of this section. Any items (ii) The beneficiary meets the § 425.316 [Amended] or services provided in violation of eligibility criteria established at paragraph (e)(3) will not be considered ■ 42. Amend 425.316— § 425.401(a) and must not be excluded to have a reasonable connection to the ■ a. In paragraph (c)(1), by removing the by the criteria at § 425.401(b). The medical care of the beneficiary, as phrase ‘‘minimum attainment level in exclusion criteria at § 425.401(b) apply required under § 425.304(a)(2). one or more domains as determined for purposes of determining beneficiary (ii) Withholding or threatening to under § 425.502 and may be subject to eligibility for alignment to ACOs under withhold medical services or limiting or a CAP. CMS, may forgo the issuance’’ all tracks based on the beneficiary’s threatening to limit access to care. and adding in its place the phrase designation of an ACO professional as ‘‘minimum attainment level on at least responsible for coordinating their ■ 44. Section 425.500 is amended by 70 percent of the measures, as overall care under paragraph (e) of this revising paragraphs (e)(2) and (3) to read determined under § 425.502, in one or section. as follows:

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§ 425.500 Measures to assess the quality performance year. The quality an ACO participant, does not of care furnished by an ACO. performance standard is the overall satisfactorily report for purposes of the * * * * * standard the ACO must meet in order to Physician Quality Reporting System (e) * * * be eligible for shared savings. payment adjustment for 2017 or 2018, (2) If, at the conclusion of the audit * * * * * each eligible professional who bills process the overall audit match rate (b) * * * under the TIN of an ACO participant between the quality data reported and (3) The minimum attainment level for will receive a payment adjustment, as the medical records provided under pay for performance measures is set at described in § 414.90(e) of this chapter, paragraph (e)(1) of this section is less 30 percent or the 30th percentile of the unless such eligible professionals have than 90 percent, absent unusual performance benchmark. The minimum reported quality measures apart from circumstances, CMS will adjust the attainment level for pay for reporting the ACO in the form and manner ACO’s overall quality score proportional measures is set at the level of complete required by the Physician Quality to the ACO’s audit performance. and accurate reporting. Reporting System. (3) If, at the conclusion of the audit * * * * * (4) For eligible professionals subject process CMS determines there is an (c) * * * to the Physician Quality Reporting audit match rate of less than 90 percent, (5) Performance equal to or greater System payment adjustment under the the ACO may be required to submit a than the minimum attainment level for Medicare Shared Savings Program for CAP under § 425.216 for CMS approval. pay-for-reporting measures will receive 2017 or 2018, the Medicare Part B * * * * * the maximum available points. Physician Fee Schedule amount for ■ 45. Section 425.502 is amended by— (d) * * * covered professional services furnished ■ a. Revising paragraph (a) introductory (2) * * * during the program year is equal to the text. (ii) CMS may take the compliance applicable percent of the Medicare Part ■ b. In paragraph (a)(1), removing the actions described in § 425.216 for ACOs B Physician Fee Schedule amount that phrase ‘‘period, CMS, CMS defines’’ and exhibiting poor performance on a would otherwise apply to such services adding in its place the phrase ‘‘period, domain, as determined by CMS under under section 1848 of the Act, as CMS defines’’. § 425.316. described in § 414.90(e) of this chapter. ■ c. In paragraphs (a)(2) and (3), * * * * * (5) The reporting period for a year is removing the phrase ‘‘level of certain ■ 46. Section 425.504 is amended by— the calendar year from January 1 measures’’ and adding in its place ‘‘level ■ a. Amending paragraph (c) to remove through December 31 that occurs 2 years of all measures’’. the phrase ‘‘for 2016 and subsequent prior to the program year in which the ■ d. In paragraph (a)(4), removing the years’’ everywhere it appears and payment adjustment is applied, unless phrases ‘‘The quality performance adding in its place the phrase ‘‘for otherwise specified by CMS under the standard for a newly’’ and ‘‘periods, the 2016’’. Physician Quality Reporting System. quality performance standard for the ■ b. Redesignating paragraph (d) as ■ 47. Section 425.506 is amended by— measure’’ and adding in their place the paragraph (c)(5). ■ a. Revising the section heading. phrases ‘‘A newly’’ and ‘‘periods, the ■ c. Adding new paragraph (d). ■ b. Amending paragraph (d) measure’’, respectively. The addition reads as follows: introductory text to remove the phrase ■ e. In paragraph (b)(2)(ii), removing the ‘‘Eligible professionals participating in § 425.504 Incorporating reporting an ACO’’ and adding in its place the phrase ‘‘95 percentt’’ and adding in its requirements related to the Physician place the phrase ‘‘95 percent’’. Quality Reporting System Incentive and phrase ‘‘Through reporting period 2016, ■ f. Revising paragraph (b)(3). Payment Adjustment. eligible professionals participating in an ■ g. In paragraph (c)(2), removing the ACO’’ phrase ‘‘level for a measure’’ and adding * * * * * ■ c. Adding paragraph (e). (d) Physician Quality Reporting in its place the phrase ‘‘level for a pay- The revision and addition read as System payment adjustment for 2017 for-performance measure’’. follows: and 2018. (1) ACOs, on behalf of eligible ■ h. Adding paragraph (c)(5). ■ i. In paragraph (d) heading, removing professionals who bill under the TIN of § 425.506 Incorporating reporting an ACO participant, must submit all of requirements related to adoption of certified the phrase ‘‘quality performance electronic health record technology. requirements’’ and adding in its place the ACO GPRO measures determined the phrase ‘‘quality requirements’’. under § 425.500 using a CMS web * * * * * ■ j. In paragraph (d)(1) introductory interface, to satisfactorily report on (e) For 2017 and subsequent years, text, removing the phrase ‘‘individual behalf of their eligible professionals for CMS will annually assess the degree of quality performance standard measures’’ purposes of the Physician Quality use of certified EHR technology by and adding in its place the phrase Reporting System payment adjustment eligible clinicians billing through the ‘‘individual measures’’. under the Shared Savings Program for TINs of ACO participants for purposes ■ k. In paragraph (d)(2) introductory 2017 and 2018. of meeting the CEHRT criterion text, removing the phrase ‘‘quality (2) Eligible professionals who bill necessary for Advanced Alternative performance requirements’’ and adding under the TIN of an ACO participant Payment Models under the Quality in its place the phrase ‘‘quality within an ACO participate under their Payment Program. (1) During years in which the measure requirements’’. ACO participant TIN as a group practice ■ l. Revising paragraph (d)(2)(ii). under the Physician Quality Reporting is designated as pay for reporting, in The revisions and addition read as System Group Practice Reporting order to demonstrate complete and follows: Option of the Shared Savings Program accurate reporting, at least one eligible for purposes of the Physician Quality clinician billing through the TIN of an § 425.502 Calculating the ACO quality Reporting System payment adjustment ACO participant must meet the performance score. under the Shared Savings Program for reporting requirements under the (a) Establishing a quality performance 2017 and 2018. Advancing Clinical Information standard. CMS designates the quality (3) If an ACO, on behalf of eligible category under the Quality Payment performance standard in each professionals who bill under the TIN of Program.

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(2) During years in which the measure the waiver under paragraph (a)(1) of this PART 460—PROGRAMS OF ALL- is designated as pay for performance, section. INCLUSIVE CARE FOR THE ELDERLY the quality measure regarding EHR (v) The following beneficiary (PACE) adoption will be measured based on a protections apply when a beneficiary sliding scale. receives SNF services without a prior 3- ■ 50. The authority citation for part 460 ■ 48. Section 425.508 is added to day inpatient hospital stay from a SNF continues to read as follows: subpart F to read as follows: affiliate that intended to provide Authority: Secs. 1102, 1871, 1894(f), and services pursuant to a SNF 3-day rule 1934(f) of the Social Security Act (42 U.S.C. § 425.508 Incorporating quality reporting waiver under paragraph (a)(1) of this 1302, 1395, 1395eee(f), and 1396u–4(f)). requirements related to the Quality Payment section, but the beneficiary was not ■ 51. Section 460.40 is amended by Program. prospectively assigned to the ACO and adding paragraph (j) to read as follows: (a) For 2017 and subsequent reporting was not in the 90 day grace period years. ACOs, on behalf of eligible under paragraph (a)(1)(iv) of this § 460.40 Violations for which CMS may clinicians who bill under the TIN of an section. The SNF affiliate services must impose sanctions. ACO participant, must submit all of the be non-covered only because the SNF * * * * * CMS web interface measures affiliate stay was not preceded by a (j) Employs or contracts with any determined under § 425.500 to qualifying hospital stay under section provider or supplier that is a type of satisfactorily report on behalf of their 1861(i) of the Act. individual or entity that can enroll in eligible clinicians for purposes of the (A) A SNF is presumed to intend to Medicare in accordance with section quality performance category of the provide services pursuant to the SNF 3- 1861 of the Act, that is not enrolled in Quality Payment Program. day rule waiver under paragraph (a)(1) Medicare in an approved status. (b) [Reserved] of this section if the SNF submitting the ■ 52. Section 460.50 is amended by ■ claim is a SNF affiliate of an ACO for 49. Section 425.612 is amended by— revising paragraph (b)(1)(ii) to read as ■ which such a waiver has been approved. a. Amending paragraph (a)(1) follows: introductory text to remove the phrase (B) CMS makes no payments for SNF ‘‘ACOs participating in Track 3 that services to a SNF affiliate of an ACO for § 460.50 Termination of PACE program receive otherwise’’ and adding in its which a waiver of the SNF 3-day rule agreement. place the phrase ‘‘ACOs participating in has been approved when the SNF * * * * * Track 3, and as provided in paragraph affiliate admits a FFS beneficiary who (b) * * * (a)(1)(iv) of this section during a grace was never prospectively assigned to the (1) * * * period for beneficiaries excluded from ACO or was prospectively assigned but (ii) The PACE organization failed to prospective assignment to a Track 3 was later excluded and the 90 day grace comply substantially with conditions ACO, who receive otherwise’’. period under paragraph (a)(1)(iv) of this for a PACE program or PACE ■ b. Adding paragraphs (a)(1)(iv), section has lapsed. organization under this part, or with (C) In the event that CMS makes no (a)(1)(v), and (d)(4). terms of its PACE program agreement, payment for SNF services furnished by The additions read as follows: including employing or contracting with a SNF affiliate as a result of paragraph any provider or supplier that are types § 425.612 Waivers of payment rules or (a)(1)(v)(B) of this section and the only of individuals or entities that can enroll other Medicare requirements. reason the claim was non-covered is due in Medicare in accordance with section (a) * * * to the lack of a qualifying inpatient stay, 1861 of the Act, that is not enrolled in (1) * * * the following beneficiary protections (iv) For a beneficiary who was will apply: Medicare in an approved status. included on the prospective assignment (1) The SNF must not charge the * * * * * list under § 425.400(a)(3) for a beneficiary for the expenses incurred for ■ 53. Section 460.68 is amended by performance year for a Track 3 ACO for such services; and adding paragraph (a)(4) to read as which a waiver of the SNF 3-day rule (2) The SNF must return to the follows: has been approved under paragraph beneficiary any monies collected for § 460.68 Program integrity. (a)(1) of this section, but who was such services; and subsequently excluded from the ACO’s (3) The ACO may be required to (a) * * * prospective assignment list, CMS makes submit a corrective action plan under (4) That are not enrolled in Medicare payment for SNF services furnished to § 425.216(b) for CMS approval. If after in an approved status, if the providers the beneficiary by a SNF affiliate if the being given an opportunity to act upon or suppliers are of the types of following conditions are met: the corrective action plan the ACO fails individuals or entities that can enroll in (A) The beneficiary was prospectively to come into compliance with the Medicare in accordance with section assigned to the ACO at the beginning of requirements of paragraph (a)(1), 1861 of the Act. the applicable performance year but was approval for the SNF 3-day rule waiver * * * * * excluded in the most recent quarterly under this section will be terminated as ■ 54. Section 460.70 is amended by update to the prospective assignment provided under paragraph (d) of this adding paragraph (b)(1)(iv) to read as list under § 425.401(b). section. follows: (B) The SNF services are furnished to * * * * * a beneficiary who was admitted to a (d) * * * § 460.70 Contracted services. SNF affiliate within 90 days following (4) CMS reserves the right to take * * * * * the date that CMS delivers the quarterly compliance action, including (b) * * * exclusion list to the ACO. termination, against an ACO for (1) * * * (C) But for the beneficiary’s exclusion noncompliance with program rules, (iv) Providers or suppliers that are from the ACO’s prospective assignment including misuse of a waiver under this types of individuals or entities that can list, CMS would have made payment to section, as specified at §§ 425.216 and enroll in Medicare in accordance with the SNF affiliate for such services under 425.218. section 1861 of the Act, must be * * * * * enrolled in Medicare and be in an

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approved status in Medicare in order to a PACE participant who receives his or program, the PACE organization must provide health care items or services to her Medicare benefit through a PACE notify the enrollee and the excluded or a PACE participant who receives his or organization. revoked individual or entity in writing, her Medicare benefit through a PACE ■ 59. Section 460.86 is added to subpart as directed by contract or other organization. E to read as follows: direction provided by CMS, that * * * * * payments will not be made. Payment § 460.86 Payment to providers or suppliers ■ may not be made to, or on behalf of, an 58. Section 460.71 is amended by excluded or revoked. adding paragraph (b)(7) to read as individual or entity that is exclude by follows: (a) A PACE organization may not pay, the OIG or is revoked in the Medicare directly or indirectly, on any basis, for program. § 460.71 Oversight of direct participant items or services (other than emergency Dated: October 24, 2016. care. or urgently needed services as defined Andrew M. Slavitt, * * * * * in § 460.100) furnished to a Medicare (b) * * * enrollee by any individual or entity that Acting Administrator, Centers for Medicare & Medicaid Services. (7) Providers or suppliers that are is excluded by the Office of the types of individuals or entities that can Inspector General (OIG) or is revoked Dated: October 27, 2016. enroll in Medicare in accordance with from the Medicare program. Sylvia M. Burwell, section 1861 of the Act, must be (b) If a PACE organization receives a Secretary, Department of Health and Human enrolled in Medicare and be in an request for payment by, or on behalf of, Services. approved status in Medicare in order to an individual or entity that is excluded [FR Doc. 2016–26668 Filed 11–2–16; 4:15 pm] provide health care items or services to by the OIG or is revoked in the Medicare BILLING CODE 4120–01–P

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