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DEPARTMENT OF HEALTH AND related to the Radiation Oncology model participants. The Model HUMAN SERVICES Model. performance period for the RO Model [email protected], for will begin on January 1, 2021, and end Centers for Medicare & Medicaid questions related to the ESRD Treatment December 31, 2025. We will implement Services Choices Model. the payment adjustments under the ETC SUPPLEMENTARY INFORMATION: Model beginning January 1, 2021 and 42 CFR Part 512 ending June 30, 2027. Current Procedural Terminology (CPT) Copyright Notice These models will offer participants [CMS–5527–F] the opportunity to examine and better Throughout this final rule, we use understand their own care processes RIN 0938–AT89 ® CPT codes and descriptions to refer to and patterns with regard to beneficiaries ® Medicare Program; Specialty Care a variety of services. We note that CPT receiving RT services for cancer, and codes and descriptions are copyright Models To Improve Quality of Care and beneficiaries with ESRD, respectively. 2020 American Medical Association. All Reduce Expenditures ® We chose these focus areas for the Rights Reserved. CPT is a registered models because, as discussed in AGENCY: Centers for Medicare & trademark of the American Medical sections III. and IV. of this final rule, we Medicaid Services (CMS), HHS. Association (AMA). Applicable Federal believe that participants in these models ACTION: Final rule. Acquisition Regulations (FAR) and will have a significant opportunity to Defense Federal Acquisition Regulations redesign care and improve the quality of SUMMARY: This final rule implements (DFAR) apply. care furnished to beneficiaries receiving two new mandatory Medicare payment I. Executive Summary and Background these services. models under section 1115A of the We believe the models will further the Social Security Act—the Radiation A. Executive Summary agency’s goal of increasing the extent to Oncology Model (RO Model) and the 1. Purpose which CMS initiatives pay for value and End-Stage Renal Disease (ESRD) The purpose of this final rule is to outcomes, rather than for volume of Treatment Choices Model (ETC Model). services alone, by promoting the The RO Model will promote quality and implement and test two new mandatory models under the authority of the alignment of financial and other financial accountability for providers incentives for health care providers and suppliers of radiotherapy (RT). The Center for Medicare and Medicaid Innovation (Innovation Center), and to caring for beneficiaries receiving RO Model will be a mandatory payment treatment for cancer or ESRD. Payments model and will test whether making implement certain general provisions that will be applicable to both the RO that are made to health care providers prospective episode payments to for assuming financial accountability for hospital outpatient departments (HOPD) Model and the ETC Model. Section 1115A of the Social Security Act (the the cost and quality of care create and freestanding radiation therapy incentives for the implementation of centers for RT episodes of care preserves Act) authorizes the Innovation Center to test innovative payment and service care redesign among model participants or enhances the quality of care and other providers and suppliers. furnished to Medicare beneficiaries delivery models expected to reduce Medicare, Medicaid, and Children’s CMS is testing several models, while reducing Medicare program Health Insurance Program (CHIP) including voluntary models focused spending through enhanced financial expenditures while preserving or specifically on cancer and ESRD. The accountability for RO Model enhancing the quality of care furnished RO and ETC Models will require the participants. The ETC Model will be a to the beneficiaries of such programs. participation of providers and suppliers mandatory payment model focused on Under the Medicare fee-for-service that might not otherwise participate in encouraging greater use of home dialysis (FFS) program, Medicare generally these models, and will be tested in and kidney transplants, in order to makes a separate payment to providers multiple geographic areas. preserve or enhance the quality of care and suppliers for each item or service The models will allow CMS to test furnished to Medicare beneficiaries furnished to a beneficiary during the models with provider and supplier while reducing Medicare expenditures. course of treatment. Because the amount participation when there are differences The ETC Model adjusts Medicare of payments received by a provider or in: (1) Historic care and utilization payments on certain dialysis and supplier for such items and services patterns; (2) patient populations and dialysis-related claims for participating varies with the volume of items and care patterns; (3) roles within their local ESRD facilities and clinicians caring for services furnished to a beneficiary, some markets; (4) volume of services; (5) beneficiaries with ESRD—or Managing providers and suppliers may be levels of access to financial, community, Clinicians—based on their rates of home financially incentivized to or other resources; and (6) levels of dialysis transplant waitlisting, and inappropriately increase the volume of population and health care provider living donor transplants. We believe items and services furnished to receive density. As noted in the proposed rule, that these two models will test ways to higher payments. Medicare FFS may we believe that participation in these further our goals of reducing Medicare also detract from a provider’s or models by a large number of providers expenditures while preserving or supplier’s incentive to invest in quality and suppliers with diverse enhancing the quality of care furnished improvement and care coordination characteristics will result in a robust to beneficiaries. activities if it means those activities will data set for evaluating the models’ DATES: These regulations are effective result in payment for fewer items and proposed payment approaches and will on November 30, 2020. services. As a result, care may be stimulate the rapid development of new FOR FURTHER INFORMATION CONTACT: fragmented, unnecessary, or duplicative. evidence-based knowledge. Testing Rebecca Cole, (410) 786–1589, The goal for these models is to these models in this manner will also [email protected], for preserve or enhance the quality of care allow us to learn more about patterns of questions related to General Provisions. furnished to beneficiaries while inefficient utilization of health care [email protected], or 1– reducing program spending through services and how to incentivize quality 844–711–2664 Option 5, for questions enhanced financial accountability for improvement for beneficiaries receiving

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services for RT and ESRD, which could beneficiaries by encouraging more fewer doses, also known as fractions) inform future model design. efficient care delivery and incentivizing will encourage more efficient care We solicited public comment on our higher value care across episodes of delivery and incentivize higher value proposals, and on any alternatives care. The RO Model will have a care. considered. CMS has made a number of performance period of 5 calendar years, (b) RO Model Scope modifications to the formatting and beginning January 1, 2021, and ending language used in the regulation text (for December 31, 2025. The RO Model will We are finalizing criteria for the types example, to revise ‘‘pursuant to’’ to capture all complete RO episodes that of cancer included under the RO Model ‘‘under’’; and ‘‘shall’’ to ‘‘must’’) to end during the performance period, and list 16 cancer types that meet our improve readability. These formatting which means that the data collection, criteria. These cancer types are and language changes are not intended RO episode payments, and commonly treated with RT and, to be substantive. Any substantive reconciliation will continue into therefore, RT services for such cancer change(s) to this final rule is noted in calendar year 2026. types can be accurately priced for the specific section(s) affected by the purposes of a prospective episode (1) Summary of the RO Provisions change(s). payment model. RO episodes will (a) RO Model Overview include most RT services furnished in 2. Summary of the Major Provisions HOPDs and freestanding radiation RT is a common treatment for patients therapy centers during a 90-day period. a. General Provisions undergoing cancer treatment and is We are finalizing that participation in typically furnished by a physician at The general provisions will be the RO Model will be mandatory for all either an HOPD or a freestanding applicable only to participants in the RT providers and RT suppliers within radiation therapy center. The RO Model RO Model and the ETC Model. We selected geographic areas. We will use will include prospective payments for identified the general provisions based Core-Based Statistical Areas (CBSAs) certain RT services furnished during a on similar requirements that have been delineated by the Office of Management 90-day RO episode for included cancer repeatedly memorialized in various and Budget 1 as the geographic area for types for certain Medicare beneficiaries. documents governing participation in the randomized selection of RO The included cancer types will be existing model tests. We have made participants. We will link RT providers determined by the following criteria: All these provisions applicable to both the and RT suppliers to a CBSA by using are commonly treated with radiation; RO Model and ETC Model, with one the five digit ZIP Code of the location make up the majority of all incidence of exception related to termination of where RT services are furnished, cancer types; and have demonstrated model participants, so that we may permitting us to identify RO Model pricing stability. (See section III.C.5.a. of eliminate repetition in our regulations at participants while still using CBSA as a this final rule for more information.) 42 CFR part 512. The general provisions geographic unit of selection. In addition, This Model will not account for total address beneficiary protections, model we will exclude certain providers and cost of all care provided to the evaluation and monitoring, audits and suppliers from participation under the beneficiary during the 90 days of an RO record retention, rights in data and RO Model as described in section episode. Rather, the payment will cover intellectual property, monitoring and III.C.3.c. of this final rule. compliance, remedial action, model only select RT services furnished during We are including beneficiaries that termination by CMS, limitations on an RO episode. Payments for RO meet certain criteria under the RO review, and miscellaneous provisions episodes will be split into two Model. For example, these criteria will on bankruptcy and other notifications. components—the professional require that a beneficiary have a These provisions are not intended to component (PC) and the technical diagnosis of at least one of the cancer comprehensively encompass all the component (TC). This division reflects types included in the RO Model and provisions that will apply to each the fact that RT professional and that the beneficiary receive RT services model. Both the RO Model and the ETC technical services are sometimes from a participating provider or supplier Model have unique aspects that will furnished by separate RT providers and in one of the selected CBSAs. require additional, more tailored RT suppliers and paid for through Beneficiaries who meet these criteria provisions, including with respect to different payment systems (namely, the will be included in RO episodes. payment and quality measurement. Medicare Physician Fee Schedule and Such model-specific provisions are Outpatient Prospective Payment (c) RO Model Overlap With Other CMS described elsewhere in this final rule. System). Programs and Models For example, under the RO Model, a b. Radiation Oncology (RO) Model We expect that there could be participating HOPD must have at least situations where a Medicare beneficiary In this rule, we are finalizing the one PGP to furnish RT services at the included in an RO episode under the creation and testing of a new payment HOPD. A PGP will furnish the PC as a RO Model is also assigned, aligned, or model for radiation oncology, the RO Professional participant and an HOPD attributed to another Innovation Center Model. The intent of the RO Model is to will furnish the TC as a Technical model or CMS program. Overlap could promote quality and financial participant. Both will be participants in also occur among RT providers and RT accountability for episodes of care the RO Model, furnishing separate suppliers at the individual or centered on RT services. While components of the same RO episode. An organization level, such as where a preserving or enhancing the quality of RO participant may also elect to furnish radiation oncologist or his or her PGP care for Medicare beneficiaries, the RO both the PC and TC as a Dual participates in multiple Innovation Model will test whether prospective participant through one entity, such as Center models. We believe that the RO episode-based payments to physician a freestanding radiation therapy center. Model is compatible with existing group practices (PGPs), HOPDs, and The RO Model will test the cost-saving models and programs that provide freestanding radiation therapy centers potential of prospective episode opportunities to improve care and for RT episodes of care will reduce payments for certain RT services Medicare expenditures. We anticipate furnished during an RO episode and 1 See https://www.census.gov/programs-surveys/ the RO Model will benefit Medicare whether shorter courses of RT (that is, metro-micro/about/omb-bulletins.html.

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reduce spending, especially episode with a focus on clinical care and When using or disclosing such data, payment models like the Oncology Care beneficiary experience with the aim of the RO participant will be required to Model. However, we will work to identifying a reduction in expenditures make ‘‘reasonable efforts to limit’’ the resolve any potential overlaps between with preserved or enhanced quality of information to the ‘‘minimum the RO Model and other CMS models or care for beneficiaries. necessary’’ as defined by 45 CFR programs that could result in repetitive RO participants will be paid for 164.502(b) and 164.514(d) to services, or duplicative payment of reporting clinical data in accordance accomplish the intended purpose of the services, and duplicative counting of with our reporting requirements (as use, disclosure, or request. The RO savings or other reductions in discussed in section III.C.8.e. of this participant will be required to further expenditures. final rule), and paid for performance on limit its disclosure of such information aggregated quality measure data on to what is permitted by applicable law, (d) RO Model Episodes and Pricing three quality measures and pay-for- including the regulations promulgated Methodology reporting on one quality measure (for under the HIPAA and the Health We are setting a separate payment PY1 and PY2) (as discussed in section Information Technology for Economic amount for the PC and the TC of each III.C.8.f. of this final rule). We are and Clinical Health (HITECH) laws at 45 cancer type included in the RO Model. adding a set of patient experience CFR part 160 and subparts A and E of The payment amounts will be measures based on the CAHPS® Cancer part 164. Further discussion of data determined based on national base rates, Care Survey for Radiation Therapy for sharing can be found in section III.C.13. trend factors, and adjustments for each inclusion as pay-for-performance of this final rule. participant’s case-mix, historical measures. We will also require experience, and geographic location. Professional participants and Dual (g) RO Model Beneficiary Protections The payment amount will also be participants to report all quality data for We are requiring Professional adjusted for withholds for incorrect all applicable patients receiving RT participants and Dual participants to payments, quality, and starting in the services from RO participants based on notify RO beneficiaries of the third performance year (PY3), patient numerator and denominator beneficiary’s inclusion in this Model experience. The standard beneficiary specifications for each measure (for through a standardized written notice to coinsurance amounts (typically 20 example, not just Medicare beneficiaries each RO beneficiary during the percent of the Medicare-approved or beneficiaries receiving care for RO treatment planning service. We intend amount for services) and sequestration episodes). to provide a notification template, will remain in effect. RO participants which RO participants may personalize (f) RO Model Data Sharing Process will have the ability to earn back a with contact information and logos, but portion of the quality and patient We will collect quality and clinical must otherwise not be changed. Further experience withholds based on their data for the RO Model. We intend to explanation of the beneficiary reporting of clinical data, their reporting share certain data with RO participants notification can be found in section and performance on quality measures, to the extent permitted by the Health III.C.15. of this final rule. and as of PY3, performance on the Insurance Portability and beneficiary-reported Consumer Accountability Act of 1996 (HIPAA) (h) RO Model Program Policy Waivers Assessment of Healthcare Providers and Privacy Rule and other applicable law. We believe it will be necessary to Systems (CAHPS®) Cancer Care We are establishing data privacy waive certain requirements of title XVIII Radiation Therapy Survey. compliance standards for RO of the Act solely for purposes of participants. We are establishing carrying out the testing of the RO Model (e) RO Model Quality Measures and requirements around the public release under section 1115A(b) of the Act. We Reporting Requirements of patient de-identified information by will issue these waivers using our We are adopting four quality RO participants. We will offer RO waiver authority under section ® measures and will collect the CAHPS participants the opportunity to request a 1115A(d)(1) of the Act. Each of the Cancer Care Radiation Therapy Survey claims data file that contains patient- waivers is discussed in detail in section for the RO Model. Three of the four identifiable data on the RO participant’s III.C.10. of this final rule, and codified measures are National Quality Forum patient population for clinical in our regulations at § 512.280. (NQF)-endorsed process measures that treatment, care management and are clinically appropriate for RT and are coordination, and quality improvement c. ESRD Treatment Choices (ETC) Model approved for the Merit-based Incentive activities. Also, we will permit the data The ETC Model will be a mandatory Payment System (MIPS).23 We selected to be reused by RO participants for payment model, focused on encouraging all measures based on clinical provider incentive design and greater use of home dialysis and kidney appropriateness for RT services implementation, and we believe it may transplants for ESRD Beneficiaries spanning a 90-day period. These be of use in RO participants’ review of among ESRD facilities and Managing measures will be applicable to the full our calculation of their participant- Clinicians located in Selected range of included cancer types and specific episode payment amounts and Geographic Areas. The ETC Model will provide us the ability to accurately reconciliation payment amounts or include two payment adjustments. The measure changes or improvements in repayment amounts, as applicable. first payment adjustment, the Home the quality of RT services. Further, we Thus, we expect that the data offered Dialysis Payment Adjustment (HDPA), believe that these measures will allow under the RO Model will be used by RO will be a positive adjustment on certain the RO Model to apply a pay-for- participants and CMS to better home dialysis and home dialysis-related performance methodology that understand Model effects, establish claims during the initial 3 years of the incorporates performance measurement benchmarks, and monitor participant model. The second payment adjustment, compliance. Again, as previously the Performance Payment Adjustment 2 NQF endorsement summaries: http:// described, the data uses and sharing (PPA), will be a positive or negative www.qualityforum.org/News_And_Resources/ Endorsement_Summaries/Endorsement_ will be allowed only to the extent adjustment on dialysis and dialysis- Summaries.aspx. permitted by the HIPAA Privacy Rule related Medicare payments, for both 3 See the CY 2018 QPP final rule (82 FR 53568). and other applicable law. home dialysis and in-center dialysis,

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based on ESRD facilities’ and Managing ESRD facilities and Managing Clinicians transplant rate, calculated as the sum of Clinicians’ rates of home dialysis, and of within Selected Geographic Areas is the transplant waitlist rate and the kidney transplant waitlisting and living that we seek to test the effect of payment living donor transplant rate, during the donor transplantation, among attributed incentives on availability and choice of corresponding MY. We will be beneficiaries during the applicable MY. treatment modality among a diverse measuring rates of home dialysis, and of We are implementing the payment group of providers and suppliers. We transplant waitlisting and living donor adjustments under the ETC Model will randomly select Hospital Referral transplantation, for ESRD facilities and beginning January 1, 2021, and ending Regions (HRRs) for inclusion in the Managing Clinicians using Medicare June 30, 2027. Model, and also include all HRRs with claims data, Medicare administrative at least 20 percent of ZIP Codes located data including enrollment data, and the (1) Summary of the ETC Model in Maryland in addition to those Scientific Registry of Transplant Provisions selected through randomization in Recipients (SRTR) data. We will (a) ETC Model Overview conjunction with the Maryland Total measure home dialysis rates for ESRD Beneficiaries with ESRD generally Cost of Care Model currently being facilities and Managing Clinicians in the require some form of renal replacement tested in the state of Maryland. ETC Model by calculating the number of Managing Clinicians and ESRD facilities dialysis treatment beneficiary years therapy, the most common being located in these Selected Geographic during the MY in which attributed hemodialysis (HD), followed by Areas will be required to participate in beneficiaries received dialysis at home, peritoneal dialysis (PD), or a kidney the ETC Model and will be assessed on plus one half the total number of transplant. Most beneficiaries with their rates of home dialysis, and of dialysis treatment beneficiary years ESRD receive HD treatments in an ESRD kidney transplant waitlisting and living during the MY in which attributed facility; however, other renal donor transplantation, among their beneficiaries received self dialysis in replacement modalities—including attributed beneficiaries during each MY; center. We will measure transplant rates dialyzing at home or receiving a kidney CMS will then adjust certain of their for ESRD facilities and Managing transplant—may be better options than Medicare payments upward or Clinicians by calculating the number of in-center dialysis for more beneficiaries downward during the corresponding attributed beneficiary years during the than currently use them. We are Performance Payment Adjustment MY for which attributed beneficiaries finalizing the ETC Model to test the Period (PPA Period). Managing were on the kidney transplant waitlist effectiveness of adjusting certain Clinicians and ESRD facilities located in and by calculating the number of Medicare payments to ESRD facilities the Selected Geographic Areas will also attributed beneficiary years during the and Managing Clinicians—clinicians receive a positive adjustment on their MY for which attributed beneficiaries who furnish and bill the Monthly home dialysis and home dialysis-related received living donor transplants. The Capitation Payment (MCP) for managing claims for the first 3 years of the ETC ETC Model will make upward and ESRD Beneficiaries—to encourage Model to support home dialysis downward adjustments to certain greater utilization of home dialysis and provision before the PPA begins to payments to participating ESRD kidney transplantation, support apply. facilities under the ESRD PPS and to the beneficiary modality choice, reduce MCP paid to participating Managing (c) Home Dialysis Payment Adjustment Medicare expenditures, and preserve or Clinicians based upon the ETC (HDPA) enhance the quality of care. We believe Participant’s home dialysis rate and ESRD facilities and Managing Clinicians We will make upward adjustments to transplant rate. The magnitude of the are the key providers and suppliers certain payments made to participating positive and negative PPAs for ETC managing the dialysis care and ESRD facilities under the ESRD Participants will increase over the treatment modality options for ESRD Prospective Payment System (PPS) on course of the Model. These PPAs will Beneficiaries and have a vital role to home dialysis claims, and will make apply to claims with claim service dates play in beneficiary modality selection upward adjustments to the MCP paid to beginning July 1, 2022, and ending June and assisting beneficiaries through the participating Managing Clinicians on 30, 2027. transplant process. We are adjusting home dialysis-related claims. The HDPA payments for home dialysis and home will apply to claims with claim service (e) ETC Model Overlaps With Other dialysis-related claims with claim dates beginning on January 1, 2021, and Innovation Center Models and CMS service dates from January 1, 2021, ending on December 31, 2023. Programs through December 31, 2023 through the The ETC Model will overlap with HDPA. We also will assess the rates of (d) Home Dialysis and Transplant several other CMS programs and home dialysis and of kidney transplant Performance Assessment and models, including initiatives waitlisting and living donor Performance Payment Adjustment (PPA) specifically focusing on dialysis care. transplantation, among beneficiaries We will assess ETC Participants’ rates We believe the ETC Model will be attributed to ETC Participants during of home dialysis, and transplant compatible with other dialysis-focused the period beginning January 1, 2021, waitlisting and living donor CMS programs and models. However, and ending June 30, 2026, with the PPA transplantation, during a MY, which we will work to resolve any potential based on those rates applying to claims will include 12 months of performance overlaps between the ETC Model and for dialysis and dialysis-related services data. Each MY will overlap with the other CMS models or programs that with claim service dates beginning July previous MY, if any, and the subsequent could result in repetitive services or 1, 2022, and ending June 30, 2027. MY, if any, for a period of 6 months. duplicative payment for services. The Each MY will have a corresponding PPA payment adjustments made under the (b) ETC Model Scope Period—a 6-month period, which will ETC Model will be counted as The ETC Model will be a mandatory begin 6 months after the conclusion of expenditures under the Medicare payment model focused on encouraging the MY. We will adjust certain Shared Savings Program and other greater use of home dialysis and kidney payments for ETC Participants during shared savings initiatives. Additionally, transplants for ESRD Beneficiaries. The the PPA Period based on the ETC ESRD facilities will remain subject to rationale for a mandatory model for Participant’s home dialysis rate and the quality requirements in ESRD

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Quality Incentive Program (QIP), and the quality or experience of care for are a number of provisions from the Managing Clinicians who are MIPS beneficiaries is not harmed, and proposed rule that we intend to address eligible clinicians will remain subject to adequate patient and program integrity later and a few that we do not intend to MIPS unless otherwise excluded. safeguards are in place. finalize. We also note that some of the As part of the monitoring strategy, we public comments were outside of the (f) ETC Model Medicare Payment will be using two quality measures for scope of the proposed rule. These out- Waivers the ETC Model: The Standardized of-scope public comments are not In order to make the proposed Mortality Ratio and the Standardized addressed in this final rule. Summaries payment adjustments under the ETC Hospitalization Ratio. These measures of the public comments that are within Model, namely the HDPA and PPA, we are NQF-endorsed, and are currently the scope of the proposed rule and our will need to waive certain Medicare calculated at the ESRD facility level for responses to those public comments are program requirements. In particular, we Dialysis Facility Reports and the ESRD set forth in the various sections of this will waive certain requirements of the QIP, respectively. Therefore, we will final rule under the appropriate Act for the ESRD PPS, ESRD QIP, and require no additional reporting of heading. However, we note that in this Medicare Physician Fee Schedule only quality measures by ETC Participants. final rule we are not addressing most to the extent necessary to make the We intend to propose a beneficiary comments received with respect to the payment adjustments under the ETC experience measure in future provisions of the proposed rule that we Model for ETC Participants. In addition, rulemaking. are not finalizing at this time. Rather, we will waive certain requirements such (h) ETC Model Beneficiary Protections we will address them at a later time, in that the payment adjustments made a subsequent rulemaking document, as under the ETC Model will not change The ETC Model will not allow appropriate. beneficiary cost-sharing from the regular beneficiaries to opt out of the payment Medicare program cost-sharing for the adjustments for their ESRD facility or II. General Provisions related Part B services that were paid for Managing Clinician; however, the A. Introduction beneficiaries who receive services from Model will not restrict a beneficiary’s ETC Participants. freedom to choose an ESRD facility or Section 1115A of the Act authorizes It will also be necessary to waive Managing Clinician, or any other the Innovation Center to test innovative certain Medicare payment requirements provider or supplier, and ETC payment and service delivery models of section 1861(ggg) of the Act and Participants will be subject to the expected to reduce Medicare, Medicaid, implementing regulations at 42 CFR general provisions protecting and CHIP expenditures while preserving 410.48, regarding the use of the Kidney beneficiary freedom of choice and or enhancing the quality of care Disease Education (KDE) benefit, solely access to medically necessary covered furnished to such programs’ for the purposes of testing the ETC services. We also will require that ETC beneficiaries. The Innovation Center has Model. The purpose of such waivers Participants notify beneficiaries of the designed and tested numerous models will be to give ETC Participants ETC Participant’s participation in the governed by participation agreements, additional access to the tools necessary ETC Model by prominently displaying cooperative agreements, model-specific to ensure beneficiaries select their informational materials in ESRD addenda to existing contracts with CMS, preferred kidney replacement modality. facilities and Managing Clinician offices and regulations. While each of these As education is a key component of or facilities where beneficiaries receive models has a specific payment assisting beneficiaries with making such care. Additionally, ETC Participants methodology, quality metrics, and selections, we will waive select will be subject to the general provisions certain other applicable policies, each requirements regarding the provision of regarding descriptive model materials model also has general provisions that the KDE benefit, including waiving the and activities. are very similar, including provisions requirement that certain health care on monitoring and evaluation; provider types must furnish the KDE B. Background compliance with model requirements service to allow additional staff to In the July 18, 2019 Federal Register and applicable laws; and beneficiary furnish the service, waiving the (84 FR 34478), we published the protections. requirement that the KDE service be proposed rule titled ‘‘Medicare Program; This section of the final rule finalizes furnished to beneficiaries with Stage IV Specialty Care Models to Improve the implementation of some general CKD to allow ETC Participants to Quality of Care and Reduce provisions that will be applicable to furnish these services to beneficiaries in Expenditures’’ that would implement both the RO Model and the ETC Model. later stages of kidney disease, and two new mandatory Medicare payment These general provisions are only waiving certain restrictions on the KDE models under section 1115A of the applicable to model participants in the curriculum to allow the content to be Act—the Radiation Oncology Model RO Model and the ETC Model. The tailored to each beneficiary’s needs. (RO Model) and the End-Stage Renal general provisions being finalized here We will issue these waivers using our Disease (ESRD) Treatment Choices are based on similar provisions that waiver authority under section Model (ETC Model). have been repeatedly memorialized in 1115A(d)(1) of the Act. As we stated in the proposed rule, we various documents governing believe that these two models will test participation in existing model tests. (g) ETC Model Monitoring and Quality ways to further our goals of reducing As we noted in the proposed rule, we Measures Medicare expenditures while preserving believe it promotes efficiency to publish Consistent with the monitoring or enhancing the quality of care in section II. of this final rule certain requirements in the general provisions, furnished to beneficiaries. general provisions in each of these areas we will closely monitor the We received approximately 330 that apply to both the RO Model and the implementation and outcomes of the timely pieces of correspondence in ETC Model. This avoids the need to ETC Model throughout its duration. The response to our solicitation of public restate the same provisions separately purpose of this monitoring will be to comments on the proposed rule. While for the two models in this final rule. We ensure that the ETC Model is we are finalizing several of the will codify these general provisions in implemented safely and appropriately, provisions from the proposed rule, there a new subpart of the Code of Federal

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Regulations (42 CFR part 512, subpart one or more Innovation Center model the RO Model and the ETC Model, A). These provisions are not intended to activities. We proposed that a which include only Medicare FFS comprehensively encompass all the downstream participant may include, beneficiaries. We also proposed to provisions that will apply to each but would not be limited to, an define the term ‘‘model beneficiary’’ to model. Both the RO Model and the ETC individual practitioner, as defined for mean a beneficiary attributed to a model Model have unique aspects that require purposes of the RO Model. We proposed participant or otherwise included in an additional, more tailored provisions, to define ‘‘Innovation Center model Innovation Center model under the including with respect to payment and activities’’ to mean any activities terms of proposed part 512; as proposed, quality measurement. Such model- impacting the care of model the term ‘‘model beneficiary’’ as defined specific provisions are described beneficiaries related to the test of the in this section would include, unless elsewhere in this final rule. Innovation Center model performed otherwise specified, the term ‘‘RO We received approximately 35 timely under the terms of proposed part 512. Beneficiary’’ and beneficiaries attributed public comments on the general While not used in the general to ETC participants under § 512.360. As provisions of the proposed rule. These provisions, as this term is used for stated in the proposed rule, we believed comments were submitted by purposes of both the RO Model and the it was necessary to propose this individuals and entities with an interest ETC Model, we proposed to define definition of model beneficiary so as to in radiation oncology and kidney ‘‘U.S. Territories’’ to mean American differentiate between Medicare FFS diseases. We note that some of these Samoa, the Federated States of beneficiaries generally and those public comments were outside the Micronesia, Guam, the Marshall Islands, specifically included in an Innovation scope of the proposed rule. These out- the Commonwealth of the Northern Center model. We received no of-scope public comments are not Mariana Islands, Palau, Puerto Rico, comments on these proposed definitions addressed with the policy responses in U.S. Minor Outlying Islands, and the and therefore are finalizing these this final rule. Summaries of the public U.S. Virgin Islands. definitions in our regulation at comments that are within the scope of We solicited public comment on our § 512.110 without modification. the proposed rule and our responses to proposals regarding the basis and scope those public comments are set forth in of these general provisions. We received 1. Beneficiary Freedom of Choice this section of the final rule under the no comments on these proposals and A beneficiary’s ability to choose his or appropriate headings. therefore we are finalizing these her provider or supplier is an important proposals without modification in our principle of Medicare FFS and is B. Basis and Scope regulations at § 512.100(a). We similarly codified in section 1802(a) of the Act. In § 512.100(a), we proposed to apply did not receive comments on our To help ensure that this protection is the general provisions in section II. of proposed definitions of model not undermined by the testing of the the proposed rule only to the RO Model participant, downstream participant, or two Innovation Center models, we and the ETC Model, each of which we U.S. Territories, and are finalizing these proposed to require in § 512.120(a)(1) proposed to refer to as an ‘‘Innovation definitions as proposed in our that model participants and their Center model’’ for purposes of these regulation at § 512.110. downstream participants not restrict a general provisions. As proposed, this beneficiary’s ability to choose his or her paragraph indicated that these general C. Definitions providers or suppliers. We proposed provisions would not, except as In our regulation at § 512.110, we that this policy would apply with specifically noted in part 512, affect the proposed to define certain terms respect to all Medicare FFS applicability of other provisions relevant to the general provisions. We beneficiaries, not just model affecting providers and suppliers under describe these definitions in context beneficiaries, because we believe it is Medicare FFS, including the throughout section II. of this final rule. important to ensure that the Innovation applicability of provisions regarding To the extent we have received Center model tests do not interfere with payment, coverage, and program comments on the definitions we the general guarantees and protections integrity (such as those in parts 413, proposed, we have responded to those for all Medicare FFS beneficiaries. 414, 419, 420, and 489 of chapter IV of comments throughout section II. of this Also, in § 512.120(a)(2), we proposed 42 CFR and those in parts 1001–1003 of final rule. to codify that the model participant and chapter V of 42 CFR). its downstream participants must not In § 512.100(b), we proposed to apply D. Beneficiary Protections commit any act or omission, nor adopt the general provisions to model As we design and test new models at any policy, that inhibits beneficiaries participants in the RO Model (with one the Innovation Center, we believe it is from exercising their freedom to choose exception described later in this final necessary to have certain protections in to receive care from any Medicare- rule) and the ETC Model. We proposed place to ensure that beneficiaries retain participating provider or supplier, or to define the term ‘‘model participant’’ their existing rights and are not harmed from any health care provider who has to mean an individual or entity that is by the participation of their health care opted out of Medicare. As we noted in identified as a participant in an providers in Innovation Center models. the proposed rule, we believe this Innovation Center model under the Therefore, as noted in the proposed requirement is necessary to ensure that terms of part 512; as proposed, the term rule, we believe it is necessary to Innovation Center models do not ‘‘model participant’’ would include, propose certain provisions regarding prevent beneficiaries from obtaining the unless otherwise specified, the terms beneficiary choice, the availability of general rights and guarantees provided ‘‘RO participant’’ or ‘‘ETC Participant’’ services, and descriptive model under Medicare FFS. However, because as those terms are defined in subparts B materials and activities. we believe that it is important for model and C of part 512. We proposed to For purposes of the general participants to have the opportunity to define ‘‘downstream participant’’ to provisions, we proposed to define the explain the benefits of care provided by mean an individual or entity that has term ‘‘beneficiary’’ to mean an them to model beneficiaries, we further entered into a written arrangement with individual who is enrolled in Medicare proposed that the model participant and a model participant pursuant to which FFS. As we noted in the proposed rule, its downstream participants would be the downstream participant engages in this definition aligns with the scope of permitted to communicate to model

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beneficiaries the benefits of receiving including §§ 512.225 and 512.330 modification in our regulation at care with the model participant, if relating to beneficiary notifications for § 512.120(a). We received no comments otherwise consistent with the the RO Model and ETC Model, on the proposed definitions of provider requirements of part 512 and applicable respectively, as well as § 512.120(c) and supplier and therefore are finalizing law. relating to the requirements for these definitions without modification In § 512.110, we proposed to define materials and activities used to educate, in our regulation at § 512.110. the terms ‘‘provider’’ and ‘‘supplier,’’ as notify, or contact beneficiaries regarding 2. Availability of Services used in part 512, in a manner consistent the Innovation Center model (referred to with how these terms are used in in this final rule as descriptive model Models tested under the authority of Medicare FFS generally. Specifically, materials and activities). We would note section 1115A of the Act are designed we proposed to define the term that § 512.120(c) allows model to test potential improvements to the ‘‘provider’’ to mean a ‘‘provider of participants to provide additional delivery of and payment for health care services’’ as defined under section descriptive model materials and to reduce Medicare, Medicaid, and CHIP 1861(u) of the Act and codified in the activities to model beneficiaries that expenditures while preserving or definition of ‘‘provider’’ at 42 CFR could describe in greater detail the enhancing the quality of care for the 400.202. We similarly proposed to Innovation Center Model and its beneficiaries of these programs. As define the term ‘‘supplier’’ to mean a expected impacts on model such, as we noted in the proposed rule, ‘‘supplier’’ as defined in section 1861(d) beneficiaries. We note that this an important aspect of testing of the Act and codified at 42 CFR provision requires that all descriptive Innovation Center models is that 400.202. As stated in the proposed rule, model materials and activities must not beneficiaries continue to access and we believe it is necessary to define be materially inaccurate or misleading, receive needed care. Therefore, in ‘‘provider’’ and ‘‘supplier’’ in this way and all such materials and activities § 512.120(b)(1), we proposed that model as a means of noting to the general may be reviewed by CMS. With respect participants and downstream public that we are using the generally to the template beneficiary notifications participants are required to continue to applicable Medicare definitions of these that RO participants and ETC make medically necessary covered terms for purposes of part 512. Participants must furnish, we will not services available to beneficiaries to the We solicited comments on our provide a formal process for soliciting extent required by law. Consistent with proposals related to beneficiary freedom feedback on the content of such the limitation on Medicare coverage of choice. In this section of this final notifications because such a process under section 1862(a)(1)(A) of the Act, rule, we summarize and respond to the may interfere with the model operation we proposed to define ‘‘medically public comments received on the timelines. However, we are open to necessary’’ to mean reasonable and beneficiary freedom of choice proposal. receiving such feedback on an informal necessary for the diagnosis or treatment Comment: A few commenters thanked basis. We believe the provisions of an illness or injury, or to improve the CMS for the explicit clarification of regarding beneficiary notifications and functioning of a malformed body beneficiary rights—notably, that descriptive model materials and member. Also, we proposed to define beneficiaries maintain their right to activities strike an appropriate balance ‘‘covered services’’ to mean the scope of choose a health care provider that is not between the amount of information that health care benefits described in participating in either the RO Model or may be desired by beneficiaries and the sections 1812 and 1832 of the Act for the ETC Model. burden of ensuring that such which payment is available under Part Response: We thank the commenters information is accurate and not A or Part B of Title XVIII of the Act, for their support and for their comments misleading. which aligns with Medicare coverage in support of our proposals to maintain Additionally, as described in this standards and the definition of ‘‘covered beneficiaries’ freedom of choice and final rule, under our regulations at services’’ used in other models tested by other beneficiary protections. § 512.120(a) and (b), model beneficiaries the Innovation Center. Also, we Comment: A few commenters will retain the right to receive care from proposed that model beneficiaries and requested that CMS strengthen the the providers and suppliers of their their assignees, as defined in 42 CFR proposed beneficiary protections so that choice as well as access to the same 405.902, would retain their rights to beneficiaries are adequately educated range of benefits as other Medicare FFS appeal Medicare claims in accordance about any Innovation Center model in beneficiaries who are not receiving care with 42 CFR part 405, subpart I. As which they are included. Specifically, from an Innovation Center model noted in the proposed rule, we believe one of the commenters requested that participant. As such, we believe that our that model beneficiaries and their CMS solicit external feedback on the proposed beneficiary protections will assignees should not lose the right to contents of any beneficiary notification establish strong beneficiary safeguards appeal claims for Medicare items and letter prior to requiring its use by model for the two Innovation Center models. services furnished to them solely participants. A few commenters also However, as described in section II.H. of because the beneficiary’s provider or expressed concern that RO Model this final rule, we are also finalizing our supplier is participating in an beneficiaries, specifically, would not proposal to monitor model participant Innovation Center model. have access to the same range of benefits compliance with model terms and other Also, in § 512.120(b)(2) we proposed as other Medicare beneficiaries. applicable program laws and policies, to prohibit model participants and Response: We disagree with the including requirements related to downstream participants from taking commenters that additional safeguards beneficiary access to services and the any action to avoid treating beneficiaries are needed to ensure that model providers and suppliers of their choice. based on their income levels or based on beneficiaries will be adequately If needed, we will propose any factors that would render a beneficiary educated about the Innovation Center modifications to the applicable an ‘‘at-risk beneficiary’’ as that term is models. Specifically, we believe that beneficiary protections through future defined for purposes of the Medicare several of our finalized provisions will rulemaking. Shared Savings Program at 42 CFR provide adequate education to model After considering public comments, 425.20, a practice commonly referred to beneficiaries regarding the models in we are finalizing our proposals on as ‘‘lemon dropping.’’ For example, 42 which the beneficiaries are included, beneficiary freedom of choice without CFR 425.20 defines an ‘‘at-risk

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beneficiary’’ to include, without participants that may have ‘‘cherry- the proposed rule, we believe it is limitation, a beneficiary who has one or picked’’ or ‘‘lemon-dropped’’ necessary to ensure that those materials more chronic conditions or who is beneficiaries through various modes of and activities that are used to educate, entitled to Medicaid because of monitoring set forth in section II.H. notify, or contact beneficiaries regarding disability. As such, a model participant (general provisions), section III.C.14. the Innovation Center model are not or downstream participant would be (the RO Model), and section IV.C.10. materially inaccurate or misleading prohibited from taking action to avoid (ETC Model) of this final rule. In because these materials might be the treating beneficiaries with chronic addition, beneficiary complaints may only information that a model conditions such as obesity or diabetes, alert us to potentially inappropriate beneficiary receives regarding the or who are entitled to Medicaid because beneficiary selection or avoidance of beneficiary’s inclusion in the model. of disability. As noted in the proposed certain beneficiaries. Additionally, we understand that not all rule, we believe it is necessary to After considering public comments, communications between the model specify prohibitions on avoiding we are finalizing our proposed participant or downstream participants treating at-risk beneficiaries, including provisions on the availability of services and the model beneficiaries would those with obesity or diabetes, or who without modification in our regulation address the model beneficiaries’ care are eligible for Medicaid because of at § 512.120(b). We received no under the model. As such, we would disability, to prevent potential lemon comments on whether prohibiting note that this proposed prohibition dropping of beneficiaries. Further, we cherry-picking will prevent model would in no way restrict the ability of believe prohibiting lemon dropping is a participants from artificially inflating a model participant or its downstream necessary safeguard to counter any their financial or quality performance participants to engage in activism or incentives created by the Innovation results and therefore are not finalizing otherwise alert model beneficiaries to Center models for model participants to additional provisions against cherry- the drawbacks of mandatory models in avoid treating potentially high-cost picking in this final rule. which they would otherwise decline to beneficiaries who are most in need of 3. Descriptive Model Materials and participate, provided that such quality care. This prohibition has been Activities statements are not materially inaccurate incorporated into the governing or misleading. We did not propose to In order to protect beneficiaries from documentation of many current models regulate information or communication potentially being misled about being tested by the Innovation Center unrelated to an Innovation Center model Innovation Center models, we proposed for this same reason. Also, in because it would not advance the at § 512.120(c)(1) to prohibit model § 512.120(b)(3), we proposed an purpose of the proposed prohibition, participants and their downstream additional provision to prohibit model which is to protect model beneficiaries participants from using or distributing participants from taking any action to from being misled about their inclusion selectively target or engage beneficiaries descriptive model materials and activities that are materially inaccurate in an Innovation Center model or their who are relatively healthy or otherwise Medicare rights generally. Accordingly, expected to improve the model or misleading. For purposes of part 512, we proposed to define the term we proposed to define the term participant’s or downstream ‘‘descriptive model materials and participant’s financial or quality ‘‘descriptive model materials and activities’’ to mean general audience activities’’ such that materials unrelated performance, a practice commonly to the Innovation Center model are not referred to as ‘‘cherry-picking.’’ For materials such as brochures, advertisements, outreach events, letters subject to the requirements of example, a model participant or § 512.120(c)(1). downstream participant would be to beneficiaries, web pages, mailings, prohibited from targeting only healthy, social media, or other materials or Also, in § 512.120(c)(4) we proposed well-educated, or wealthy beneficiaries activities distributed or conducted by or to reserve the right to review, or have for voluntary alignment, the receipt of on behalf of the model participant or its our designee review, descriptive model permitted beneficiary incentives or downstream participants when used to materials and activities to determine other interventions, or the reporting of educate, notify, or contact beneficiaries whether the content is materially quality measures. regarding the Innovation Center model. inaccurate or misleading; this review We solicited comments on our Further, we proposed that the following would not be a preclearance by CMS, proposals related to availability of communications would not be but would take place at a time and in services and on whether prohibiting descriptive model materials and a manner specified by CMS once the cherry-picking would prevent model activities: Communications that do not materials and activities are in use by the participants from artificially inflating directly or indirectly reference the model participant. As noted in the their financial or quality performance Innovation Center model (for example, proposed rule, we believe it would be results. In this section of this final rule, information about care coordination necessary for CMS to have this ability to we summarize and respond to the generally); information on specific review descriptive model materials and public comments received on these medical conditions; referrals for health activities in order to protect model proposals. care items and services; and any other beneficiaries from receiving misleading Comment: A commenter applauded materials that are excepted from the or inaccurate materials regarding the CMS’s proposals to prohibit model definition of ‘‘marketing’’ as that term is Innovation Center model. Furthermore, participants from ‘‘cherry-picking’’ defined at 45 CFR 164.501. The to facilitate our ability to conduct this beneficiaries. This commenter requested potential for model participants to review and to monitor Innovation additional details on how CMS plans to receive certain payments under the two Center models generally, we proposed at identify model participants that have Innovation Center models may be an § 512.120(c)(3) to require model ‘‘cherry-picked’’ or ‘‘lemon-dropped’’ incentive for model participants and participants and downstream beneficiaries. their downstream participants to engage participants, to retain copies of all Response: We appreciate the in marketing behavior that may confuse written and electronic descriptive commenter’s support of our proposal to or mislead beneficiaries about the model materials and activities and to prohibit cherry-picking in Innovation Innovation Center model or their retain appropriate records for all other Center models. We will identify model Medicare rights. Therefore, as noted in descriptive model materials and

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activities in a manner consistent with increasing the burden on model must otherwise cooperate with CMS’ § 512.135(c) (record retention). participants and CMS by requiring a model evaluation and monitoring Also in § 512.120(c)(2), we proposed thorough review of all marketing activities as may be necessary to enable to require model participants and materials from all model participants CMS to evaluate the Innovation Center downstream participants to include the prior to their release. model in accordance with section following disclaimer on all descriptive After considering public comments, 1115A(b)(4) of the Act. This model materials and activities: ‘‘The we are finalizing our proposed participation in the evaluation may statements contained in this document provisions on descriptive model include, but is not limited to, are solely those of the authors and do materials and activities without responding to surveys and participating not necessarily reflect the views or modification in our regulation at in focus groups. Additional details on policies of the Centers for Medicare & § 512.120(c). We did not receive any the specific research questions that the Medicaid Services (CMS). The authors comments on whether we should Innovation Center model evaluation will assume responsibility for the accuracy propose a different disclaimer that alerts consider for the RO Model and ETC and completeness of the information beneficiaries that we prohibit Model can be found in in sections contained in this document.’’ We misleading information and gives them III.C.16. and IV.C.11. of this final rule, proposed to require the use of this contact information so they could reach respectively. Further, we proposed to disclaimer so that the public, and out to us if they suspect the information conduct monitoring activities according beneficiaries in particular, are not they have received regarding an to proposed § 512.150, described later in misled into believing that model Innovation Center model is inaccurate. this final rule, including producing such participants or their downstream Furthermore, we received no comments data as may be required by CMS to participants are speaking on behalf of on these proposed definition of evaluate or monitor the Innovation the agency. descriptive model materials and Center model, which may include We solicited comments on our activities and therefore are finalizing protected health information as defined proposals related to descriptive model this definition without modification in in 45 CFR 160.103 and other materials and activities. We also our regulation at § 512.110. individually identifiable data. solicited comment on whether we We solicited public comment on our E. Cooperation With Model Evaluation should propose a different disclaimer proposal regarding cooperation with and Monitoring that alerts beneficiaries that we prohibit model monitoring and evaluation misleading information and gives Section 1115A(b)(4) of the Act activities. We received no comments on beneficiaries contact information so requires the Secretary to evaluate each these proposals and therefore are they could reach out to us if they model tested under the authority of finalizing these proposals without suspect the information they have section 1115A of the Act and to publicly modification in our regulation at received regarding an Innovation Center report the evaluation results in a timely § 512.130. model is inaccurate. manner. The evaluation must include an In this section of this final rule, we analysis of the quality of care furnished F. Audits and Record Retention summarize and respond to the public under the model and the changes in By virtue of their participation in an comments received on these proposals. program spending that occurred due to Innovation Center model, model Comment: A commenter requested the model. Models tested by the participants and their downstream that CMS review all marketing materials Innovation Center are rigorously participants may receive model-specific from model participants prior to those evaluated. For example, when payments, access to payment rule materials being made available to evaluating models tested under section waivers, or some other model-specific beneficiaries in order to prevent 1115A of the Act, we require the flexibility. Therefore, as noted in the confusion or the dissemination of production of information that is proposed rule, we believe that CMS’s misleading information. This representative of a wide and diverse ability to audit, inspect, investigate, and commenter also supported the proposal group of model participants and evaluate records and other materials that descriptive model materials and includes data regarding potential related to participation in Innovation activities include the proposed unintended or undesirable effects, such Center models is necessary and disclaimer. as cost-shifting. The Secretary must take appropriate. In addition, we proposed in Response: We thank the commenter the evaluation into account if making § 512.120(b)(1) to require model for supporting our proposal to require any determinations regarding the participants and their downstream model participants include a disclaimer expansion of a model under section participants to continue to make on all descriptive model materials and 1115A(c) of the Act. medically necessary covered services activities so that the public, and model In addition to model evaluations, the available to beneficiaries to the extent beneficiaries in particular, are not Innovation Center regularly monitors required by law. Similarly, in order to misled into believing that model model participants for compliance with expand a phase 1 model tested by the participants are speaking on behalf of model requirements. For the reasons Innovation Center, among other things, CMS. We also appreciate the described in section II.H. of this final the Secretary must first determine that commenter’s recommendation that CMS rule, these compliance monitoring such expansion would not deny or limit review all marketing materials from activities are an important and the coverage or provision of benefits model participants prior to their necessary part of the model test. under the applicable title for applicable distribution; however, we believe that Therefore, we proposed to codify in individuals. Thus, as discussed in the our proposal to reserve the right to § 512.130, that model participants and proposed rule, there is a particular need review such materials once distributed their downstream participants must for CMS to be able to audit, inspect, strikes the appropriate balance. comply with the requirements of 42 CFR investigate, and evaluate records and Specifically, our final rule protects 403.1110(b) (regarding the obligation of materials related to participation in beneficiaries from receiving misleading entities participating in the testing of a Innovation Center models to allow us to information regarding Innovation Center model under section 1115A of the Act ensure that model participants are in no models without unduly delaying the to report information necessary to way denying or limiting the coverage or release of useful information or monitor and evaluate the model), and provision of benefits for beneficiaries as

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part of their participation in the Innovation Center model, including define the term ‘‘days’’ to mean calendar Innovation Center model. We proposed proposed new subpart A of proposed days. to define ‘‘model-specific payment’’ to part 512. We solicited public comment on these mean a payment made by CMS only to ++ The accuracy of model-specific proposed provisions regarding audits model participants, or a payment payments made under the Innovation and record retention. adjustment made only to payments Center model. Historically, the Innovation Center made to model participants, under the ++ The model participant’s payment has required participants in section terms of the Innovation Center model of amounts owed to CMS under the 1115A models to retain records for at that is not applicable to any other Innovation Center model. least 10 years, which is consistent with providers or suppliers; the term ‘‘model- ++ Quality measure information and the outer limit of the statute of specific payment’’ would include, the quality of services performed under limitations for the Federal False Claims unless otherwise specified, the terms the terms of the Innovation Center Act and is consistent with the Shared ‘‘home dialysis payment adjustment model, including proposed new subpart Savings Program’s policy outlined at 42 (HDPA),’’ ‘‘performance payment A of part 512. CFR 425.314(b)(2). For this reason, we adjustment (PPA),’’ ‘‘participant-specific ++ Utilization of items and services also solicited public comments on professional episode payment,’’ or furnished under the Innovation Center whether we should require model ‘‘participant-specific technical episode model. participants and downstream payment.’’ As noted in the proposed ++ The ability of the model participants to maintain records for rule, we believe it is necessary in order participant to bear the risk of potential longer than 6 years. We summarize and respond in this to distinguish payments and payment losses and to repay any losses to CMS, section of this final rule to the public adjustments applicable to model as applicable. participants as part of their participation comments received on these proposals. ++ Patient safety. Comment: A few commenters in an Innovation Center model, from ++ Any other program integrity payments and payment adjustments applauded our proposed requirement issues. for model participants and their applicable to model participants as well • Maintain the documents and other as other providers and suppliers, as downstream participants to maintain evidence for a period of 6 years from the records for at least six (6) years from the certain provisions of proposed part 512 last payment determination for the would apply only to the former category last payment determination for the model participant under the Innovation model participant under the Innovation of payments and payment adjustments. Center model or from the date of We note here and in the proposed rule Center model or from the date of completion of any audit, evaluation, that there are audit and record retention completion of any audit, evaluation, inspection, or investigation, whichever requirements under the Medicare inspection, or investigation. is later, unless— Shared Savings Program (42 CFR Response: We thank the commenters 425.314) and in current models being ++ CMS determines there is a special for their support of this proposed tested under section 1115A of the Act need to retain a particular record or policy. (such as under 42 CFR 510.110 for the group of records for a longer period and Comment: A few commenters, while Innovation Center’s Comprehensive notifies the model participant at least 30 generally supporting our proposed Care for Joint Replacement Model). days before the normal disposition date; record retention requirements, made Building off those existing or alternative suggestions for how CMS requirements, we proposed in ++ There has been a termination, should collect model-related records § 512.135(a), that the Federal dispute, or allegation of fraud or similar from model participants. Specifically, government, including, but not limited fault against the model participant in both commenters suggested that CMS to, CMS, HHS, and the Comptroller which case the records must be expressly allow for e-transmission of General, or their designees, would have maintained for an additional six (6) model-related records when requested a right to audit, inspect, investigate, and years from the date of any resulting final by CMS as this would allow additional evaluate any documents and other resolution of the termination, dispute, flexibility for model participants and be evidence regarding implementation of or allegation of fraud or similar fault. less burdensome for model participants. an Innovation Center model. If CMS notifies the model participant Response: We appreciate the Additionally, in order to align with the of a special need to retain a record or commenters’ support for our proposed policy of current models being tested by group of records at least 30 days before record retention requirements. While we the Innovation Center, in § 512.135(b) the normal disposition date, we did not propose to prohibit e- and (c) we proposed that the model proposed that the records must be transmission of records that are participant and its downstream maintained for such period of time requested by CMS, we are not finalizing participants must do the following: determined by CMS. If CMS notifies the a provision that would permit the • Maintain and give the Federal model participant of a special need to exclusive use of e-transmission for such government, including, but not limited retain records or there has been a records, as we believe that CMS should to, CMS, HHS, and the Comptroller termination, dispute, or allegation of make case-by-case determinations General, or their designees, access to all fraud or similar fault against the model regarding whether e-transmission is documents (including books, contracts, participant or its downstream appropriate. and records) and other evidence participants, the model participant must We received no comments on whether sufficient to enable the audit, notify its downstream participants of CMS should require model participants evaluation, inspection, or investigation the need to retain records for the and downstream participants to of the Innovation Center model, additional period specified by CMS. As maintain records for longer than 6 years. including, without limitation, noted in the proposed rule, this After considering public comments, we documents and other evidence provision will ensure that that the are finalizing our proposals on audits regarding all of the following: government has access to the records. and record retention as proposed in our ++ Compliance by the model To avoid any confusion or disputes regulation at § 512.135. We received no participant and its downstream regarding the timelines outlined in these comments on the proposed definitions participants with the terms of the general provisions, we proposed to for model-specific payments and days;

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and therefore, are finalizing these H. Monitoring and Compliance caregivers; (5) site visits to the model definitions without modification in our Given that model participants may participant and its downstream regulation at § 512.110. receive model-specific payments, access participants, which would be performed in a manner consistent with proposed G. Rights in Data and Intellectual to payment rule waivers, or some other § 512.150(c), described later in this rule; Property model-specific flexibility while participating in an Innovation Center (6) monitoring quality outcomes and To enable CMS to evaluate the model, as noted in the proposed rule, registry data; and (7) tracking patient Innovation Center models as required by we believe that enhanced compliance complaints and appeals. We believe section 1115A(b)(4) of the Act and to review and monitoring of model these specific monitoring activities, monitor the Innovation Center models participants is necessary and which align with those currently used pursuant to § 512.150, in § 512.140(a) appropriate to ensure the integrity of the in other models being tested by the we proposed to use any data obtained in Innovation Center, are necessary to accordance with §§ 512.130 and 512.135 Innovation Center model. In addition, as part of the Innovation Center’s ensure compliance with the terms and to evaluate and monitor the Innovation conditions of the Innovation Center Center models. We further proposed assessment of the impact of new Innovation Center models, we have a model, including proposed subpart A of that, consistent with section proposed part 512, and to protect 1115A(b)(4)(B) of the Act, that CMS special interest in ensuring that model tests do not interfere with ensuring the beneficiaries from potential harms that would be allowed to disseminate may result from the activities of a model integrity of the Medicare program. Our quantitative and qualitative results and participant or its downstream interests include ensuring the integrity successful care management techniques, participants, such as attempts to reduce and sustainability of the Innovation including factors associated with access to or the provision of medically Center model and the underlying performance, to other providers and necessary covered services. suppliers and to the public. We Medicare program, from both a financial We proposed to codify in proposed that the data to be and policy perspective, as well as § 512.150(b)(2), that when we are disseminated would include, but would protecting the rights and interests of conducting compliance monitoring and not be limited to, patient de-identified Medicare beneficiaries. For these oversight activities, CMS or its results of patient experience of care and reasons, as a part of the models designees would be authorized to use quality of life surveys, as well as patient currently being tested by the Innovation any relevant data or information, de-identified measure results calculated Center, CMS or its designee monitors including without limitation Medicare based upon claims, medical records, model participants to assess compliance claims submitted for items or services and other data sources. with model terms and with other furnished to model beneficiaries. As In order to protect the intellectual applicable program laws and policies. noted in the proposed rule, we believe property rights of model participants As noted in the proposed rule, we that it is necessary to have all relevant and downstream participants, in believe our monitoring efforts help information available to us during our § 512.140(c) we proposed to require ensure that model participants are compliance monitoring and oversight model participants and their furnishing medically necessary covered activities, including any information downstream participants to label data services and are not falsifying data, already available to us through the they believe is proprietary that they increasing program costs, or taking other Medicare program. believe should be protected from actions that compromise the integrity of We proposed to require in disclosure under the Trade Secrets Act. the model or are not in the best interests § 512.150(c)(1) that model participants As we noted in the proposed rule, this of the model, the Medicare program, or and their downstream participants approach is already in use in other Medicare beneficiaries. cooperate in periodic site visits models currently being tested by the In § 512.150(b)(1), we proposed to conducted by CMS or its designee in a Innovation Center, including the Next continue this standard practice of manner consistent with § 512.130, Generation Accountable Care conducting monitoring activities for described previously. Such site visits Organization Model. Any such several reasons: (1) To ensure would be conducted to facilitate the assertions would be subject to review compliance by the model participant model evaluation performed pursuant to and confirmation prior to CMS’s acting and each of its downstream participants section 1115A(b)(4) of the Act and to upon such assertion. with the terms of the Innovation Center monitor compliance with the Innovation We further proposed to protect such model, including the requirements of Center model terms (including proposed information from disclosure to the full proposed subpart A of proposed part subpart A of proposed part 512). extent permitted under applicable laws, 512; (2) to understand model In order to operationalize this including the Freedom of Information participants’ use of model-specific proposal, in § 512.150(c)(2) we proposed Act. Specifically, in § 512.140(b), we payments; and (3) to promote the safety that CMS or its designee would provide proposed that we would not release data of beneficiaries and the integrity of the the model participant or its downstream that has been confirmed by CMS to be Innovation Center model. Such participant with no less than 15 days proprietary trade secret information and monitoring activities would include, but advance notice of a site visit, to the technology of the model participant or not be limited to: (1) Documentation extent practicable. Furthermore, to the its downstream participants without the requests sent to the model participant extent practicable, we proposed that express written consent of the model and its downstream participants, CMS would attempt to accommodate a participant or its downstream including surveys and questionnaires; request that a site visit be conducted on participant, unless such release is (2) audits of claims data, quality a particular date, but that the model required by law. measures, medical records, and other participant or downstream participant We solicited public comment on these data from the model participant and its would be prohibited from requesting a proposals. We received no comments on downstream participants; (3) interviews date that was more than 60 days after these proposals and therefore are with members of the staff and the date of the initial site visit notice finalizing these proposals without leadership of the model participant and from CMS. We believe the 60-day period modification in our regulation at its downstream participants; (4) would reasonably accommodate model § 512.140. interviews with beneficiaries and their participants’ and downstream

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participants’ schedules while not requirements have been waived notify CMS of suspected errors in the interfering with the operation of the pursuant to section 1115A(d)(1) of the calculation of their reconciliation Innovation Center model. Further, in Act solely for purposes of testing the payment amount or repayment amount § 512.150(c)(3) we proposed to require Innovation Center model in which the or aggregate quality score as reflected on the model participant and their model participant is participating. an RO reconciliation report that has not downstream participants to ensure that To protect the financial integrity of been deemed final. In addition, in personnel with the appropriate each Innovation Center model, in section IV.C.5.h. of this final rule, we responsibilities and knowledge § 512.150(d) we proposed that if CMS have finalized the proposed process for pertaining to the purpose of the site visit discovers that it has made or received ETC Participants to request a targeted be available during any and all site an incorrect model-specific payment review of the calculation of the visits. As noted in the proposed rule, we under the terms of an Innovation Center Modality Performance Score (MPS). believe this proposal is necessary to model, CMS may make payment to, or We understand the commenter to be ensure an effective site visit and prevent demand payment from, the model advocating that RO participants should the need for unnecessary follow-up site participant. We did not propose a have the right to request reopening of a visits. deadline for making or demanding such model-specific payment determination. Also, in § 512.150(c)(4), we proposed payments, but we stated that we were By way of background, a reopening is an that CMS or its designee could perform considering the imposition of some of administrative action taken to change a unannounced site visits to the offices of the deadlines set forth in the Medicare binding determination or decision that model participants and their reopening rules at 42 CFR 405.980. resulted in either an overpayment or downstream participants at any time to Specifically, we sought comment on underpayment, even though the binding investigate concerns related to the whether CMS should be able to reopen determination or decision may have health or safety of beneficiaries or other an initial determination of a model- been correct at the time it was made patients or other program integrity specific payment for any reason within based on the evidence of record (see issues, notwithstanding these 1 year of the model-specific payment, § 405.980(a)). Under the Medicare provisions. Further, in § 512.150(c)(5) and within 4 years for good cause (as reopening rules, a party to an initial we proposed that nothing in proposed defined at 42 CFR 405.986). As noted in determination may request that the part 512 would limit CMS from the proposed rule, we believe this may determination be reopened in a variety performing other site visits as allowed be necessary to ensure we have a means of circumstances, including within one or required by applicable law. As noted and a timeline to make redeterminations year for any reason and within four in the proposed rule, we believe that, on incorrect model-specific payments years for good cause (as defined at regardless of the model being tested, that we have made or received in § 405.986). The Medicare reopening CMS must always have the ability to conjunction with the proposed rules also permit a CMS contractor to timely investigate concerns related to Innovation Center models. reopen an initial determination on its the health or safety of beneficiaries or We proposed to codify at § 512.150(e) own motion for a variety reasons, other patients, or program integrity that nothing contained in the terms of including: (1) Within 1 year for any issues, and to perform functions the Innovation Center model or reason; (2) within 4 years for good cause required or authorized by law. In proposed part 512 would limit or (as defined at § 405.986); and (3) at any particular, we believe that it is restrict the authority of the HHS Office time if there is reliable evidence (as necessary for us to monitor, and for of Inspector General (OIG) or any other defined at § 405.902) that the initial model participants and their Federal government authority, including determination was procured by fraud or downstream participants to be its authority to audit, evaluate, similar fault (as defined at § 405.902). compliant with our monitoring efforts, investigate, or inspect the model Under § 405.986, ‘‘good cause’’ may be to ensure that they are not denying or participant or its downstream established when there is new and limiting the coverage or provision of participants for violations of any material evidence that was not available medically necessary covered services to statutes, rules, or regulations or known at the time of the beneficiaries in an attempt to change administered by the Federal determination or decision and that may model results or their model-specific government. This provision simply result in a different conclusion or when payments, including discrimination in reflects the limits of CMS authority. the evidence that was considered in the provision of services to at-risk We solicited comments on these making the determination or decision beneficiaries (for example, due to proposals related to monitoring and clearly shows on its face that an obvious eligibility for Medicaid based on compliance. In this section of this final error was made at the time of the disability). rule, we summarize and respond to the determination or decision. Under the Model participants that are enrolled public comments received on these existing reopening rules, the decision in Medicare will remain subject to all proposals and comment solicitations. whether to grant a request for reopening existing requirements and conditions for Comment: A commenter expressed its is within the sole discretion of CMS and Medicare participation as set out in support for our proposal to permit CMS is not reviewable (see § 405.980(a)(5)). Federal statutes and regulations and to make corrections to model-specific As noted previously in this final rule, provider and supplier agreements, payments. This commenter also we did not propose any temporal unless waived under the authority of suggested that RO participants be restrictions on when CMS could correct section 1115A(d)(1) of the Act solely for permitted to initiate requests to make prior payments, but we stated in the purposes of testing the Innovation corrections to model-specific payments proposed rule that we were considering Center model. Therefore, in in the RO Model. the imposition of some of the deadlines § 512.150(a), we proposed to require Response: We thank this commenter set forth in the Medicare reopening that model participants and each of for their support of the proposed policy. rules at 42 CFR 405.980. We specifically their downstream participants must We would note that in section III.C.12. sought comment regarding whether comply with all applicable laws and of this final rule, we have finalized the CMS should be able to reopen an initial regulations. We noted in the proposed proposed process, with a modification determination of a model-specific rule that a law or regulation is not to allow for 45 days instead of the payment for any reason within 1 year of ‘‘applicable’’ to the extent that its proposed 30 days, for RO participants to the model-specific payment, and within

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4 years for good cause (as defined at 42 should be conducted by personnel and procured by fraud or similar fault (as CFR 405.986). After consideration of the contractors that can provide RO defined in § 405.902); and (3) CMS’s public comments, we believe that model participants with certification, decision regarding whether to reopen a participants should have a limited licensure, or other form of demonstrated model-specific payment determination opportunity to request the reopening of knowledge in the specific field of is binding and not subject to appeal. a model-specific payment radiation oncology. Finally, we have revised paragraph (e) determination. Specifically, we will Response: We disagree with the for brevity, which now states that this permit the reopening of a model-specific commenters’ belief that site visits of RO final rule does not limit or restrict the payment determination, whether on participants must be conducted by authority of the OIG or any other CMS’ own motion or at the request of personnel and contractors that have Federal government authority to audit, a model participant, for good cause (as certification, licensure, or other form of evaluate, investigate, or inspect model defined at § 405.986) within 4 years demonstrated knowledge in the specific participants or their downstream after the date of the determination. This field of radiation oncology. We reiterate participants for violations of ‘‘Federal reopening provision will help to ensure that the proposed site visits were statutes, rules, or regulations.’’ accurate payments under an Innovation intended to ensure compliance with the Center model, while the temporal and Innovation Center model terms, to I. Remedial Action ‘‘good cause’’ limitations will promote facilitate the model evaluation, and to As stated in the proposed rule and efficient use of administrative resources investigate concerns related to the earlier in this final rule, as part of the and the eventual finality of payment health or safety of beneficiaries or other Innovation Center’s monitoring and determinations. In addition, we are patients or other program integrity assessment of the impact of models finalizing a policy that permits CMS to issues. tested under the authority of section reopen a model-specific payment There are a variety of reasons for us 1115A of the Act, we have a special determination at any time if there exists to conduct site visits. While having a interest in ensuring that these model reliable evidence (as defined at certain amount of knowledge of the field tests do not interfere with the program § 405.902) that the determination was of radiation oncology may be necessary integrity interests of the Medicare procured by fraud or similar fault (as to conduct some site visits of RO program. For this reason, we monitor for defined at § 405.902). The purpose of participants, depending on the nature compliance with model terms as well as this provision is to remediate fraud and and purpose of the site visit, knowledge other Medicare program rules. When we abuse that may not be discovered within of the RO Model terms as well as become aware of noncompliance with four years of the initial payment general Medicare policies and these requirements, it is necessary for determination. procedures may be more important. As CMS to have the ability to impose Finally, consistent with the existing such, we are not accepting the certain administrative remedial actions Medicare reopening rules, the decision commenters’ suggestion to require the on a noncompliant model participant. to grant or deny a reopening request in personnel and contractors conducting As we noted in the proposed rule, the an Innovation Center model with site visits to provide RO participants terms of many models currently being respect to a model-specific payment is with certification, licensure, or other tested by the Innovation Center permit solely at CMS discretion and not form of demonstrated knowledge in the CMS to impose one or more reviewable. For example, for purposes specific field of radiation oncology. administrative remedial actions to of an Innovation Center Model, CMS After considering public comments, address noncompliance by a model may exercise its discretion to reopen a we are finalizing our proposals on participant. We proposed that CMS model-specific payment determination monitoring and compliance in our would impose any of the remedial to correct a clerical error that constitutes regulation at § 512.150 with actions set forth in proposed good cause for reopening under modification. Specifically, to align the § 512.160(b) if we determine that the § 405.986(a)(2). We note that if CMS regulatory text with the proposals model participant or a downstream reopens a model-specific payment discussed in the preamble to the participant— determination, the revised payment proposed rule, we have modified the • Has failed to comply with any of determination may be appealed in regulatory text at § 512.150(b)(1) to the terms of the Innovation Center accordance with the applicable reference additional purposes for which model, including proposed subpart A of Innovation Center model regulations, CMS may conduct monitoring activities, proposed part 512; including § 512.170 (limitations on namely to understand model • Has failed to comply with any review). participants’ use of model-specific applicable Medicare program We do not believe, however, that it is payments; and to promote the safety of requirement, rule, or regulation; necessary to permit the reopening of a beneficiaries and the integrity of the • Has taken any action that threatens model-specific payment determination Innovation Center model. In addition, in the health or safety of a beneficiary or for any reason within 1 year after the response to public comment, we have other patient; determination has been made. The modified paragraph (d) of § 512.150 to • Has submitted false data or made reopening rule we are finalizing here codify the reopening process. false representations, warranties, or adequately protects payment accuracy, Specifically, paragraph (d) has been certifications in connection with any especially in light of the review revised to state the following: (1) CMS aspect of the Innovation Center model; procedures set forth for the RO Model may reopen a model-specific payment • Has undergone a change in control at § 512.290 and for the ETC Model at determination, either on its own motion (as defined in section II.L. of this final § 512.390. Moreover, as noted above, or at the request of a model participant, rule) that presents a program integrity this final rule permits CMS to correct within four years from the date of the risk; clerical errors that it determines determination for good cause (as • Is subject to any sanctions of an constitute ‘‘good cause’’ for reopening. defined at § 405.986); (2) CMS may accrediting organization or a Federal, We are finalizing our reopening policy reopen a model-specific payment state, or local government agency; at § 512.150(d). determination at any time if there exists • Is subject to investigation or action Comment: A commenter stated that reliable evidence (as defined in by HHS (including the HHS–OIG and on-site monitoring of RO participants § 405.902) that the determination was CMS) or the Department of Justice due

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to an allegation of fraud or significant the two types of participants in the ETC K. Limitations on Review misconduct, including being subject to Model. We plan to monitor the RO In § 512.170, we proposed to codify the filing of a complaint or filing of a Model for program integrity and fraud the preclusion of administrative and criminal charge, being subject to an and abuse issues, and if necessary, we judicial review under section indictment, being named as a defendant may add a termination provision for RO 1115A(d)(2) of the Act. in a False Claims Act qui tam matter in participants in future rulemaking. Section 1115A(d)(2) of the Act states which the Federal government has We solicited public comment on these that there is no administrative or intervened, or similar action; or proposals regarding remedial action. We judicial review under section 1869 or • Has failed to demonstrate improved received no comments on these 1878 of the Act or otherwise for any of performance following any remedial proposals and therefore are finalizing the following: action imposed by CMS. these proposals our regulation at • The selection of models for testing In § 512.160(b), we proposed to codify § 512.160. or expansion under section 1115A of the that CMS may take one or more of the J. Innovation Center Model Termination Act. following remedial actions if CMS • by CMS The selection of organizations, sites, determined that one or more of the or participants to test models selected. grounds for remedial action described in In the proposed rule, we proposed • The elements, parameters, scope, § 512.160(a) had taken place— certain provisions that would allow and duration of such models for testing • Notify the model participant and, if CMS to terminate an Innovation Center or dissemination. appropriate, require the model model under certain circumstances. • Determinations regarding budget participant to notify its downstream Section 1115A(b)(3)(B) of the Act neutrality under section 1115A(b)(3) of participants of the violation; requires the Innovation Center to the Act. • Require the model participant to terminate or modify the design and • The termination or modification of provide additional information to CMS implementation of a model, after testing the design and implementation of a or its designees; has begun and before completion of the model under section 1115A(b)(3)(B) of • Subject the model participant to testing, unless the Secretary determines, the Act. additional monitoring, auditing, or both; and the Chief Actuary certifies with • Determinations about expansion of • Prohibit the model participant from respect to program spending, that the the duration and scope of a model under distributing model-specific payments; model is expected to: Improve the section 1115A(c) of the Act, including • Require the model participant to quality of care without increasing the determination that a model is not terminate, immediately or by a deadline program spending; reduce program expected to meet criteria described in specified by CMS, its agreement with a spending without reducing the quality paragraph (1) or (2) of such section. downstream participant with respect to of care; or improve the quality of care We proposed to interpret the the Innovation Center model; and reduce spending. preclusion from administrative and • In the ETC Model only, terminate In § 512.165(a), we proposed that judicial review regarding the Innovation the ETC Participant from the ETC CMS could terminate an Innovation Center’s selection of organizations, sites, Model; Center model for reasons including, but or participants to test models selected to • Require the model participant to not limited to, the following preclude from administrative and submit a corrective action plan in a form circumstances: judicial review our selection of a model and manner and by a deadline specified • CMS determines that it no longer participant, as well as our decision to by CMS; has the funds to support the Innovation terminate a model participant, as these • Discontinue the provision of data Center model; or determinations are part of our selection • sharing and reports to the model CMS terminates the Innovation of participants for Innovation Center participant; Center model in accordance with model tests. • Recoup model-specific payments; section 1115A(b)(3)(B) of the Act. In addition, we proposed to interpret • Reduce or eliminate a model As provided by section 1115A(d)(2)(E) the preclusion from administrative and specific payment otherwise owed to the of the Act and proposed § 512.170, we judicial review regarding the elements, model participant, as applicable; or noted in the proposed rule that • parameters, scope, and duration of Such other action as may be termination of the Innovation Center models for testing or dissemination, to permitted under the terms of proposed model in accordance with section preclude from administrative and part 512. 1115A(b)(3)(B) of the Act would not be judicial review the following CMS As stated in the proposed rule, we subject to administrative or judicial determinations made in connection noted that because the ETC Model is a review. with an Innovation Center model: mandatory model, we would not expect To ensure model participants had • The selection of quality to use the provision that would allow appropriate notice in the case of the performance standards for the CMS to terminate an ETC Participant’s termination of the Innovation Center Innovation Center model by CMS. participation in the ETC Model, except model by CMS, we also proposed to • The assessment by CMS of the in circumstances in which the ETC codify at § 512.165(b) that we would quality of care furnished by the model Participant has engaged, or is engaged provide model participants with written participant. in, egregious actions. We would note notice of the model termination, which • The attribution of model that we did not propose and are would specify the grounds for beneficiaries to the model participant by therefore not finalizing a provision termination as well as the effective date CMS, if applicable. authorizing CMS to terminate RO of the termination. We solicited comments on these participants from the RO Model. The We solicited public comment on these proposals regarding limitations on types of providers and suppliers proposals regarding the termination of review. In this section of this final rule, selected for participation in the RO an Innovation Center model by CMS. we summarize and respond to the Model do not present the same risk of We received no comments on these public comments received on these fraud and abuse that has historically proposals; and therefore, are finalizing proposals. been present in the dialysis industry, these proposals without modification in Comment: A commenter suggested which includes ESRD facilities, one of our regulation at § 512.165. that model participants be afforded the

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opportunity to challenge any adverse participant may owe money to CMS. As or to such other address as may be assessments relating to that model we noted in the proposed rule, we specified for purposes of receiving such participant’s quality of care through recognize that the legal entity that is the notices on the CMS website. administrative or judicial review. model participant may experience As we noted in the proposed rule, by Response: We reiterate that the significant organizational or financial requiring the submission of the filed limitations on administrative and changes during and even after the bankruptcy petition, CMS would obtain judicial review established in section period of performance for an Innovation information necessary to protect its 1115A(d)(2) of the Act include a Center model. To protect the integrity of interests, including the date on which preclusion from review for the elements, the Innovation Center models and the bankruptcy petition was filed and parameters, scope, and duration of such Medicare funds, we proposed a number the identity of the court in which the models for testing or dissemination. We of provisions to ensure that CMS is bankruptcy petition was filed. We proposed to interpret this provision as made aware of events that could affect recognize that such notices may already precluding from review the assessment a model participant’s ability to perform be required by existing law, but CMS by CMS of the quality of care furnished its obligations under the Innovation often does not receive them in a timely by the model participant. However, after Center model, including the payment of fashion, and they may not specifically reviewing this language in light of the any monies owed to CMS. identify the models in which the concern flagged by the commenter, we First, in § 512.180(a), we proposed individual or entity is participating or realize that our proposed regulatory text that a model participant must promptly has participated. The failure to receive was confusing. Our intent was to notify CMS and the local U.S. Attorney such notices on a timely basis can interpret the preclusion in section Office if it files a bankruptcy petition, prevent CMS from asserting a claim in 1115A(d)(2)(C) of the Act related to the whether voluntary or involuntary. the bankruptcy case. We are particularly elements, parameters, scope, and Because final payment may not take concerned that a model participant may duration of a model to apply to the place until after the model participant not furnish notice of bankruptcy after it methodology used to assess the quality ceases active participation in the has completed its performance in a of care furnished by a model Innovation Center model or any other model, but before final payment has participant, as this is an element of the model in which the model participant is been made or administrative or judicial design of an Innovation Center model. participating or has participated (for proceedings have been resolved. As we We did not intend to preclude from example, because the period of noted in the proposed rule, we believe review a determination regarding how performance for the model ends, or the our proposal is necessary to protect the that methodology is applied to a model participant is no longer eligible financial integrity of the Innovation particular model participant. We are to participate in the model), we further Center models and the Medicare Trust therefore modifying the text of proposed that this requirement would Funds. Because bankruptcies filed by § 512.170(c)(2) to refer to the apply until final payment has been individuals and entities that owe CMS methodology used by CMS to assess of made by either CMS or such model money are generally handled by CMS the quality of care furnished by the participant under the terms of each regional offices, we stated that we were model participant. For the same reason, model in which the model participant is considering (and we solicited comment we are modifying the text of participating or has participated and all on) whether we should require model § 512.170(c)(3) to similarly refer to the administrative or judicial review participants to furnish notice of methodology used by CMS to attribute proceedings relating to any payments bankruptcy to the local CMS regional model beneficiaries to the model under such models have been fully and office instead of, or in addition to, the participant, if applicable. We believe it finally resolved. Baltimore headquarters. is appropriate to codify the statutory Specifically, we proposed that the Second, in § 512.180(b), we proposed limitations on judicial and notice of the bankruptcy must be sent by that the model participant, including administrative review in our regulations certified mail within 5 days after the model participants that are individuals, and that our interpretations thereof, bankruptcy petition has been filed and would have to provide written notice to with these clarifications, are consistent that the notice must contain a copy of CMS at least 60 days before any change with the statute. We also agree with the the filed bankruptcy petition (including in the model participant’s legal name commenter’s assertion that model its docket number) and a list of all became effective. The notice of legal participants should be allowed to models tested under section 1115A of name change would have to be in a form challenge adverse assessments that are the Act in which the model participant and manner specified by CMS and not precluded, and have laid out a is participating or has participated. To include a copy of the legal document policy specifically allowing this for the minimize the burden on model effecting the name change, which would RO Model (section III.C.12. of this final participants, while ensuring that CMS have to be authenticated by the rule) and the ETC Model (section obtains the information necessary from appropriate state official. As we stated IV.C.5.h. of this final rule). model participants undergoing in the proposed rule, the purpose of this After considering public comments, bankruptcy, we proposed that the list notice requirement is to ensure the we are finalizing our proposals on need not identify a model in which the accuracy of our records regarding the limitations on review in our regulation model participant participated if final identity of model participants and the at § 512.170 with the modifications payment has been made under the terms entities to whom model-specific described previously in this final rule. of the model and all administrative or payments should be made or against judicial review proceedings regarding whom payments should be demanded L. Miscellaneous Provisions on model-specific payments between the or recouped. We solicited comment on Bankruptcy and Other Notifications model participant and CMS have been the typical procedure for effectuating a Models currently being tested by the fully and finally resolved with respect legal entity’s name change and whether Innovation Center usually have a to that model. We proposed that the 60 days advance notice of such a change defined period of performance, but final notice to CMS must be addressed to the is feasible. Alternatively, we considered payment under the model may occur CMS Office of Financial Management, requiring notice to be furnished long after the end of this performance Mailstop C3–01–24, 7500 Security promptly (for example, within 30 days) period. In some cases, a model Boulevard, Baltimore, Maryland 21244 after a change in legal name has become

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effective. We solicited public comment suppliers. In this section of this final referred to as radiation therapy services) on this alternative approach. rule, we summarize and respond to the will reduce Medicare program Third, in § 512.180(c), we proposed public comments received on the expenditures and preserve or enhance that the model participant would have proposal to require model participants quality of care for beneficiaries. As to provide written notice to CMS at least to notify CMS of a change in legal name. radiation oncology is highly technical 90 days before the effective date of any Comment: A few commenters and furnished in well-defined episodes, change in control. We proposed that the generally supported the proposed and because patient comorbidities written notification must be furnished procedure for notifying CMS of a name generally do not influence treatment in a form and manner specified by CMS. change. However, the commenters noted delivery decisions, as we stated in the For purposes of this notice obligation, that they would prefer that the model proposed rule, we believe that radiation we proposed that a ‘‘change in control’’ participant be required to notify CMS 30 oncology is well-suited for testing a would mean any of the following: (1) days after a legal name change, instead prospective episode payment model. The acquisition by any ‘‘person’’ (as of 60 days before, as they believe that Under the RO Model proposals, such term is used in sections 13(d) and would reduce the administrative burden Medicare would pay participating 14(d) of the Securities Exchange Act of of complying with the proposed providers and suppliers a site-neutral, 1934) of beneficial ownership (within requirement for model participants. episode-based payment for specified the meaning of Rule 13d–3 promulgated Response: We solicited comment on professional and technical RT services under the Securities Exchange Act of whether to require the model furnished during a 90-day episode to 1934), of beneficial ownership (within participant to provide CMS with written Medicare fee-for-service (FFS) the meaning of Rule 13d–3 promulgated notice 30 days after a legal name beneficiaries diagnosed with certain under the Securities Exchange Act of change. We agree with the commenters’ cancer types. We proposed that the base 1934), directly or indirectly, of voting assertion that notifying CMS of a legal payment amounts for RT services securities of the model participant name change 30 days after the name included in the Model would be the representing more than 50 percent of the change occurs would be less same for hospital outpatient model participant’s outstanding voting burdensome for model participants. We departments (HOPDs) and freestanding securities or rights to acquire such further believe that written notice radiation therapy centers. We proposed securities; (2) the acquisition of the received within 30 days after the name that the performance period for the RO model participant by any individual or change occurs would provide CMS with Model would be 5 performance years entity; (3) the sale, lease, exchange or sufficient notice to ensure the accuracy (PYs), beginning in 2020, and ending other transfer (in one transaction or a of our records. December 31, 2024, with final data series of transactions) of all or We did not receive comments submission of clinical data elements substantially all of the assets of the regarding our proposals to require the and quality measures in 2025 to account model participant; or (4) the approval model participant to notify CMS for episodes ending in 2024 (84 FR and completion of a plan of liquidation regarding bankruptcy or a change in 34493 through 34503). of the model participant, or an control. After considering public We included the following proposals agreement for the sale or liquidation of comments, we are finalizing our for the Model in the proposed rule: (1) the model participant. We noted in the proposals on bankruptcy and other The scope of the Model, including proposed rule that the proposed notifications in our regulation at required participants and episodes requirement and definition of change in § 512.180, with modification to under the Model test; (2) the pricing control are the same requirements and § 512.180(b) to change the timeline methodology under the Model and definition used in certain models that under which a model participant must necessary Medicare program policy are currently being tested under section provide written notice to CMS regarding waivers to implement such 1115A authority. We further noted that a legal name change from 60 days in methodology; (3) the quality measures we believe this notice requirement is advance of a legal name change to 30 selected for the Model for purposes of necessary to ensure the accuracy of our days after the legal name change occurs. scoring a participant’s quality records regarding the identity of model We have also made a non-substantive performance; (4) the process for participants and to ensure that we pay modification to our regulation text at and seek payment from the correct payment reconciliation; and (5) data § 512.110 to correct a drafting error in entity. For this reason, we proposed that collection and sharing. We solicited the final rule that removes the if CMS determined in accordance with comments on these proposals. duplicative text from the definition of § 512.160(a)(5) that a model change in control. participant’s change in control would B. Background present a program integrity risk, CMS III. Radiation Oncology Model 1. Overview could take remedial action against the A. Introduction model participant under § 512.160(b). In CMS is committed to promoting addition, to ensure payment of amounts As discussed in the proposed rule (84 higher quality of care and improving owed to CMS, we proposed that CMS FR 34478), we proposed to establish a outcomes for Medicare beneficiaries may require immediate reconciliation mandatory Radiation Oncology Model while reducing costs. Accordingly, as and payment of all monies owed to CMS (RO Model), referred to throughout part of that effort, we have in recent by a model participant that is subject to section III. of this final rule as ‘‘the years undertaken a number of initiatives a change in control. Model’’, to test whether prospective to improve cancer treatment, most We solicited comments on these episode-based payments for notably with our Oncology Care Model proposals. Also, we solicited comment radiotherapy (RT) services,4 (also (OCM). As we stated in the proposed as to whether the requirement to rule (84 FR 34490), we believe that a provide notice regarding changes in 4 Radiotherapy (RT) services (also referred to as model in radiation oncology will further legal name and changes in control are radiation therapy services) are services associated these efforts to improve cancer care for with cancer treatment that use high doses of necessary, or are already covered by radiation to kill cancer cells and shrink tumors, and existing reporting requirements for encompass treatment consultation, treatment (simulation), treatment delivery, and treatment Medicare-enrolled providers and planning, technical preparation and special services management.

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Medicare beneficiaries and reduce billed for) a higher volume of RT payments only within established Medicare expenditures. services within such episodes than did payment methodologies such as under RT is a common treatment for nearly HOPDs. Based on our analysis of section 1848 of the Act governing the two thirds of all patients undergoing Medicare FFS claims data from that PFS; cancer treatment 56 and is typically time period, episodes of care in which • The Practice Expense (PE) furnished by a radiation oncologist. As RT was furnished at a freestanding component of the PFS is determined we discussed in the proposed rule (84 radiation therapy center were, on based on resource inputs (labor, FR 34490), we analyzed Medicare FFS average, paid approximately $1,800 (or equipment, and supplies) and input claims between January 1, 2015, and 11 percent) more by Medicare than price estimates from entities paid under December 31, 2017, to examine several those episodes of care where RT was the PFS only, which means the PE aspects (including but not limited to furnished at an HOPD. As we stated in calculation does not consider HOPD modalities, number of fractions, length the proposed rule (84 FR 34490), we are cost data that the RO Model proposed to of episodes, Medicare payments and not aware of any clinical rationale that use as the basis for national base rates; sites of service, as described in this explains these differences, which • Further, the PE methodology itself section) of radiation services furnished persisted after controlling for diagnosis, calculates a PE amount for each service to Medicare beneficiaries during that patient case mix (to the extent possible relative to all of the other services paid period. We used HOPD and Medicare using data available in claims), under the PFS in a budget neutral Physician Fee Schedule (PFS) claims, geography, and other factors. These manner and consistent with estimates of accessed through CMS’ Chronic differences also persisted even though appropriate division of PFS payments Conditions Data Warehouse (CCW), to Medicare payments are lower per unit between PE, physician work, and identify all FFS beneficiaries who in freestanding radiation therapy centers malpractice resource costs; and received any radiation treatment than in HOPDs. Upon further analysis, • Under the PFS and OPPS, the same delivery services within that 3-year as we noted in the proposed rule (84 FR payment rate applies for a service, period. These radiation treatment 34490), we observed that freestanding irrespective of the diagnosis, whereas delivery services included various types radiation therapy centers use more 7 the proposed rule for the RO Model of modalities. Such modalities IMRT, a type of RT associated with would establish different payments by included external beam radiotherapy higher Medicare payments, and perform cancer type. (such as 3-dimensional conformal more fractions (that is, more RT • Neither the PFS nor OPPS payment radiotherapy (3DCRT)), intensity- treatments) than HOPDs. systems would allow flexibility in modulated radiotherapy (IMRT), testing new and comparable approaches stereotactic radiosurgery (SRS), 2. Site-Neutral Payments to value-based payment outside of stereotactic body radiotherapy (SBRT), Under Medicare FFS, RT services statutory quality reporting programs. and proton beam therapy (PBT); furnished in a freestanding radiation intraoperative radiotherapy (IORT); therapy center are paid under the As we stated in the proposed rule (84 image-guided radiation therapy (IGRT); Medicare PFS at the non-facility rate FR 34490 through 34491), we believe a and brachytherapy. As discussed in the including payment for the professional site-neutral payment policy will address proposed rule (84 FR 34490), we and technical aspects of the services. the site-of-service payment differential conducted several analyses of radiation For RT services furnished in an that exists under the OPPS and PFS by treatment patterns using that group of outpatient department of a hospital, the establishing a common payment amount beneficiaries and their associated facility services are paid under the to pay for the same services regardless Medicare Part A and Medicare Part B Hospital Outpatient Prospective of where they are furnished. In addition, claims. Payment System (OPPS) and the we stated our belief that site-neutral Our analysis, as discussed in the professional component of the services payments would offer RT providers and proposed rule (84 FR 34490), showed are paid under the PFS. As we RT suppliers more certainty regarding that from January 1, 2015 through discussed in the proposed rule (84 FR the pricing of RT services and remove December 31, 2017, HOPDs furnished 34490 through 34491), differences in the incentives that promote the provision of 64 percent of episodes nationally, while underlying rate-setting methodologies RT services at one site of service over freestanding radiation therapy centers used in the OPPS and PFS to establish another. The RO Model is designed to furnished the remaining 36 percent of payment for RT services in the HOPD test these assumptions regarding site- episodes. In the proposed rule we stated and in the freestanding radiation neutrality. that our intention was to make this data therapy centers respectively help to 3. Aligning Payments to Quality and publically accessible in a summary- explain why the payment rate for the Value, Rather Than Volume level, de-identified file titled the ‘‘RO same RT service could be different Episode File (2015–2017),’’ on the RO depending on the setting in which it is As discussed in the proposed rule (84 Model’s website, and we posted it for furnished. This difference in payment FR 34491), for some cancer types, commenters’ reference in conjunction rate, which is commonly referred to as stages, and characteristics, a shorter with the publication of the proposed the site-of-service payment differential, course of RT treatment with more rule. In the proposed rule (84 FR 34490), may incentivize Medicare providers and radiation per fraction may be we discussed that our analysis also suppliers to deliver RT services in one appropriate. For example, several showed that, on average, freestanding setting over another, even though the randomized controlled trials have radiation therapy centers furnished (and actual treatment and care received by shown that shorter treatment schedules Medicare beneficiaries for a given for low-risk breast cancer yield similar 5 Physician Characteristics and Distribution in the modality is the same in both settings. cancer control and cosmetic outcomes U.5., 2010 Edition, 2004 IMV Medical Information We proposed to test a site-neutral as longer treatment schedules.891011 As Division, 2003 SROA Benchmarking Survey. payment in the RO Model rather than 6 2012/13 Radiation Therapy Benchmark Report, implementing a payment adjustment in 8 Whelan, T.J. et al. Long-term Results of IMV Medical Information Division, Inc. (2013). Hypofractionated Radiation Therapy for Breast 7 the OPPS or PFS because— Modality refers to various types of radiotherapy, • Cancer. N. Engl. J. Med. 2010 Feb. 11; 362(6):513– which are commonly classified by the type of The Secretary of Health and Human 20. https://www.ncbi.nlm.nih.gov/pubmed/ radiation particles used to deliver treatment. Services has limited authority to adjust 20147717.

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another example, research has shown providers and suppliers can bill for RT increasing use of new technologies. that radiation oncologists may split services and an array of necessary Specifically, we reviewed codes for RT treatment for bone metastases into 5 to planning services to make the treatment services for Calendar Years (CYs) 2009, 10 fractions, even though research successful.18 We discussed that this 2012, 2013, and 2015 as potentially indicates that one fraction is often structure may incentivize providers and misvalued services. In general, when a sufficient.12 13 14 15 In addition, recent suppliers to furnish longer courses of code is identified as potentially clinical trials have demonstrated that, RT because they are paid more for misvalued, we use notice and comment for some patients in clinical trials with furnishing more services. Importantly, rulemaking to propose and finalize the low- and intermediate-risk prostate however, the latest clinical evidence code as misvalued, and then review the cancer, courses of RT lasting 4 to 6 suggests that shorter courses of RT for Work and PE RVU inputs for the code. weeks lead to similar cancer control and certain types of cancer would be equally As a result of the review, we may engage toxicity as longer courses of RT lasting effective and could improve the patient in further rulemaking to adjust the Work 7 to 8 weeks.16 17 experience, potentially reduce cost for or PE inputs either upward or Based on our review of claims data, the Medicare program, and lead to downward. The criteria for identifying we discussed our belief that the current reductions in beneficiary cost-sharing. potentially misvalued codes are set forth Medicare FFS payment systems may As discussed in the proposed rule (84 in section 1848(c)(2)(K)(ii) of the Act. incentivize selection of a treatment plan FR 34491), there is also some indication As described in the proposed rule (84 with a high volume of services over that the latest evidence-based guidelines FR 34492), through annual rulemaking another medically appropriate treatment are not incorporated into practices’ for the PFS, we review and adjust values plan that requires fewer services. Each treatment protocols in a timely for potentially misvalued services, and time a patient requires radiation, manner.19 For example, while breast also establish values for new and cancer guidelines have since 2008 revised codes. We establish Work and 9 Bentzen, S.M. et al. The UK Standardisation of recommended that radiation oncologists PE RVU inputs for new, revised, and Breast Radiotherapy (START) Trial A of use shorter courses of treatment for potentially misvalued codes based on a Radiotherapy Hypofractionation for Treatment of Early Breast Cancer: A Randomised Trial. Lancet lower-risk breast cancer (3 weeks versus review of information that generally Oncol. 2008 Apr.; 9(4):331–41. https:// 5 weeks), an analysis found that, as of includes, but is not limited to, www.ncbi.nlm.nih.gov/pubmed/18356109. 2017, only half of commercially insured recommendations received from the 10 Bentzen, S.M. et al. The UK Standardisation of patients actually received the shorter American Medical Association’s RVS Breast Radiotherapy (START) Trial B of course of treatment.20 Update Committee (AMA/RUC), Health Radiotherapy Hypofractionation for Treatment of Care Professional Advisory Committee Early Breast Cancer: A Randomised Trial. Lancet 4. CMS Coding and Payment Challenges Oncol. 2008 Mar. 29; 371(9618): 1098–107. https:// (HCPAC), Medicare Payment Advisory www.ncbi.nlm.nih.gov/pubmed/18355913. In the proposed rule (84 FR 34491 Commission (MedPAC), and other 11 Haviland, J.S. et al. The UK Standardisation of through 34492) we identified several public commenters; medical literature Breast Radiotherapy (START) Trials of coding and payment challenges for RT Radiotherapy Hypofractionation for Treatment Of and comparative databases; a Early Breast Cancer: 10-Year Follow-Up Results of services. Under the PFS, payment is set comparison of the work for other codes Two Randomised Controlled Trials. Lancet Oncol. for each service using resource-based within the PFS; and consultation with 2013 Oct.; 14(11): 1086–94. https:// relative value units (RVUs). The RVUs other physicians and health care www.ncbi.nlm.nih.gov/pubmed/24055415. have three components: Clinician work professionals within CMS and other 12 Sze, W.M. et al. Palliation of Metastatic Bone (Work), practice expense (PE), and Pain: Single Fraction Versus Multifraction federal government agencies. We also Radiotherapy—A Systematic Review of The professional liability or malpractice consider the methodology and data used Randomised Trials. Cochrane Database Syst. Rev. insurance expense (MP). In setting the to develop the recommendations 2004; (2):CD004721. https://www.ncbi.nlm.nih.gov/ PE RVUs for services, we rely heavily on submitted to us by the RUC and other pubmed/15106258. voluntary submission of pricing public commenters, and the rationale 13 Chow, E. et al. Update on the Systematic information for supplies and equipment, Review of Palliative Radiotherapy Trials for Bone for their recommendations. Metastases. Clin. Oncol. (R. Coll. Radiol.). 2012 and we have limited means to validate Through the annual rulemaking Mar; 24(2):112–24. https://www.ncbi.nlm.nih.gov/ the accuracy of the submitted process previously described, we have pubmed/22130630. information. As a result, it is difficult to reviewed and finalized payment rates 14 Chow, Ronald et al. Efficacy of Multiple establish the cost of expensive capital for several RT codes over the past few Fraction Conventional Radiation Therapy for equipment, such as a linear accelerator, Painful Uncomplicated Bone Metastases: A years. The American Medical Systematic Review. Radiotherapy & Oncology: in order to determine PE RVUs for Association identified radiation March 2017 Volume 122, Issue 3, Pages 323–331. physicians’ services that use such treatment codes for review because of http://www.thegreenjournal.com/article/S0167- equipment.21 site of service anomalies. We first 8140(16)34483-8/abstract. Further, as we discussed in the identified these codes as potentially 15 Lutz, Stephen et al. Palliative Radiation proposed rule (84 FR 34492), we Therapy for Bone Metastases: Update of an ASTRO misvalued services during CY 2012 Evidence-Based Guideline. Practical Radiation examined RT services and their under a screen called ‘‘Services with Oncology (2017) 7, 4–12. http:// corresponding codes under our Stand-Alone PE Procedure Time.’’ We www.practicalradonc.org/article/S1879- potentially misvalued codes initiative observed significant discrepancies 8500(16)30122-9/pdf. based on their high volume and between the 60-minute procedure time 16 D. Dearnaley, I. Syndikus, H. Mossop, et al. Conventional versus hypofractionated high-dose assumptions for IMRT and public intensity-modulated radiotherapy for prostate 18 These planning and technical preparation information which suggested that the cancer: 5-year outcomes of the randomised, non- services include dose planning, treatment aids, CT procedure typically took between 5 and inferiority, phase 3 CHHiP trial. Lancet Oncol, 17 simulations, and other services. 19 30 minutes. In CY 2015, the American (2016), pp. 1047–1060, http:// http://www.npr.org/sections/health-shots/2017/ ® www.sciencedirect.com/science/article/pii/ 10/21/558837836/many-breast-cancer-patients- Medical Association CPT Editorial S1470204516301024. receive-more-radiation-therapy-than-needed. Panel revised the entire code set that 17 W.R. Lee, J.J. Dignam, M.B. Amin, et al. 20 https://www.practicalradonc.org/cms/10.1016/ describes RT delivery. CMS proposed Randomized phase III noninferiority study j.prro.2018.01.012/attachment/775de137-63cb- values for these services in the CY 2016 comparing two radiotherapy fractionation 4c5d-a7f9-95556340d0f6/mmc1.pdf. schedules in patients with low-risk prostate cancer. 21 CY 2014 PFS final rule with comment period proposed rule but, due to challenges in J Clin Oncol, 34 (2016), pp. 2325–2332, http:// (78 FR 43296, 43286 through 43289, and 43302 revaluing the new code set, finalized the ascopubs.org/doi/full/10.1200/JCO.2016.67.0448. through 43311). use of G-codes that we established to

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largely mirror the previous radiation stakeholders representing freestanding opportunity for RT stakeholders to treatment coding structure.22 The radiation therapy centers and submit written comments about a Patient Access and Medicare Protection physicians who furnish services in potential APM. A review of the Act (PAMPA) (Pub. L. 114–115), freestanding radiation therapy centers. applicable evidence cited in the Report enacted on December 28, 2015, In recent years, these stakeholder to Congress demonstrated that episode addressed payment for certain RT comments have noted the differences payment models can be a tool for delivery and related imaging services and complexity in payment rates and improving quality of care and reducing under the PFS, and the Bipartisan policies for RT services between the PFS expenditures. Episode payment models Budget Act (BBA) of 2018 (Pub. L. 115– and OPPS; expressing particular pay a fixed price based on the expected 123) required the PFS to use the same concerns about differences in payment costs to deliver a bundle of services for service inputs for these codes as existed for RT services furnished in a clinically defined episode of care. In in 2016 for CY 2017, 2018, and 2019. freestanding radiation therapy centers the proposed rule, we stated our belief (The PAMPA and BBA of 2018 are and HOPDs despite the fact that the that radiation oncology is a promising discussed in detail in this rule). fixed, capital costs associated with area of health care for episode Despite the previously discussed linear accelerators that are used to payments, in part, based on the findings challenges related to information used furnish these services do not differ in the Report to Congress. While the to establish payment rates for RT across settings; and raising certain report discusses several options for an services, the proposed rule (84 FR perceived deficiencies in the PFS rate- APM, in the proposed rule, we proposed 34492) noted that we have setting methodology as it applies to RT what the Innovation Center has systematically attempted to improve the services delivered in freestanding determined to be the best design for accuracy of payment for these codes radiation therapy centers.23 It is also testing an episodic APM for RT services. under the PFS. While the potentially important to note that even if we were The following is a summary of misvalued code review process is able to obtain better pricing information comments we received on the proposed essential to the PFS, some stakeholders for inputs, PFS rates are developed to goals of the RO Model and the issues have expressed concern that changes in maintain relativity among other PFS addressed in section III.B. of the Work and PE RVUs have led to office-based services, and generally proposed rule and our responses to fluctuations in payment rates. without consideration of OPPS payment these comments: Occasionally, changes in PE RVUs for rates. Comment: Many commenters one or more CPT® codes occur outside As previously noted, the PAMPA supported most aspects of the proposed of the misvalued code review cycle if addressed payment for certain RT RO Model and expressed commitment there are updates to the equipment and delivery and related imaging services to fully participating in a value-based supply pricing. Any changes to CPT® under the PFS. Specifically, section 3 of care model. A commenter recommended code valuations, including supply and the PAMPA directed CMS to maintain that CMS finalize the RO Model as equipment pricing changes, are subject the 2016 code definitions, Work RVU mandatory, site-neutral, and inclusive of to public comment and review. inputs, and PE RVU inputs for 2017 and all proposed modalities. Several The proposed rule further explained 2018 for certain RT delivery and related commenters expressed their support that although the same code sets imaging services; prohibited those codes and encouraged CMS to have value- generally are used for purposes of the from being considered as potentially based programs that allow health care PFS and OPPS, there are differences misvalued codes for 2017 and 2018; and providers, through shared decision- between the codes used to describe RT directed the Secretary to submit a making with their patients, to determine services under the PFS and the OPPS, Report to Congress on development of appropriate and convenient delivery and those in commercial use more an episodic alternative payment model options. A few commenters noted broadly (84 FR 34492). We continue to (APM) for Medicare payment for appreciation for CMS’ commitment to use some CMS-specific coding, or radiation therapy services furnished in providing participants with stable rates. HCPCS codes, in billing and payment non-facility settings. Section 51009 of Some commenters expressed support for for RT services under the PFS, while we the BBA of 2018 extended these clinical episode-related payments and ® generally use CPT codes under the payment policies through 2019. In the removal of payment on a per OPPS. As a result of coding and other November 2017, we submitted the fraction basis. A few of these differences, these payment systems Report to Congress as required by commenters also expressed their utilize different payment rates and section 3(b) of the PAMPA.24 In the support of the transition to value-based reporting rules for the same services, report, we discussed the current status care solutions. which contribute to site-of-service of RT services and payment, and Response: We thank these payment differentials. These differences reviewed model design considerations commenters for their support of our in payment systems can create for a potential APM for RT services. efforts to move forward with the RO confusion for RT providers and RT In the proposed rule (84 FR 34493), Model. We are finalizing the RO Model suppliers, particularly when they we described how the Innovation as mandatory (see section III.C.3.a. of furnish services in both freestanding Center, in preparing the Report to this final rule) with the modification of radiation therapy centers and HOPDs. Congress, conducted an environmental a low volume opt-out (see section Finally, as noted in the proposed rule scan of current evidence and held a III.C.3.c. of this final rule), site-neutral (84 FR 34492), there are coding and public listening session followed by an (see section III.C.6.c. of this final rule), payment challenges specific to and inclusive of all proposed modalities 23 freestanding radiation therapy centers. See generally, CY 2018 PFS final rule with except for IORT (see section III.C.5.d. of Through the annual PFS rulemaking comment period, 82 FR 52976; CY 2015 PFS final rule with comment period, 79 FR 67547; CY 2014 this final rule). process, we receive comments from PFS final rule with comment period, 78 FR 43296. Comment: A commenter expressed 24 United States Department of Health and Human concern that CMS has not provided 22 See generally, CY 2015 PFS final rule with Services Report to Congress: Episodic Alternative comment period (79 FR 67547); CY 2016 PFS final Payment Model for Radiation Therapy Services. enough evidence to indicate that RT rule with comment period (80 FR 70885); and CY (Nov. 2019). https://innovation.cms.gov/resources/ services for cancer are over utilized and 2016 PFS correcting amendment (81 FR 12024). radiationapm-pubforum.html. to support the application of a standard

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set of RT services for cancer patients technologies within a connected compared to the physician office setting through a bundled payment program. healthcare system. of freestanding radiation therapy centers Response: We understand this Response: Although several as HOPDs provide wraparound services, commenter’s concerns. However, we Innovation Center models and programs such as translators and other social disagree with this commenter. We have include the use of telehealth services, at services that are not otherwise billable, performed extensive research, and we this time, there are no permanent and face requirements set by regulators have received numerous stakeholders’ Medicare telehealth codes included in and accreditors to which physician requests to create an alternative the list of included RT services in offices are not subject. payment model in the radiotherapy section III.C.5.c. We note that HCPCS Response: As we documented in the space. For more information on our Code 77427 has been temporarily added proposed rule and in the November research and rationale, please see to the list of Medicare telehealth codes 2017 Report to Congress (see section sections III.B.3. and III.B.4. of this final for the public health emergency (PHE) III.B.4 of the proposed rule at 84 FR rule, and 84 FR 34491 through 34493 of for the COVID–19 pandemic. RT 34491 through 34493 and this final rule the proposed rule. services can only be furnished via for background on the November 2017 Comment: A commenter suggested telehealth to the extent permitted under Report to Congress), differences in the that CMS allow RT providers and RT the Medicare telehealth coverage and underlying methodologies used in the suppliers to select appropriate radiation payment rules. Participants can OPPS and PFS for rate setting often modalities based on nationally continue to furnish telehealth services result in differences in the payment rate recognized clinical guidelines to ensure in accordance with current coverage and for the same RT service depending on that beneficiaries receive evidence- payment guidelines. We are taking this whether the service is furnished in a based care. comment into consideration for future freestanding radiation therapy center Response: The Model encourages the rulemaking. paid under the PFS, or an HOPD paid Comment: Some commenters use of nationally recognized, evidence- under the OPPS. We refer to this as the expressed concerns with the episode- based clinical treatment guidelines. We site-of-service payment differential, and based payment concept and indicated will monitor the use of guidelines we believe that such differentials that such programs may put patients’ during the Model. between HOPDs and freestanding safety at risk (for example, increased Comment: A commenter requested radiation therapy centers are radiation exposure to healthy tissues). that CMS take on more risk sharing, unwarranted because the actual One of these commenters requested that treatment and care received by patients reduce the savings targets, reimburse CMS prioritize total-cost-of-care models for a given modality is the same in each administrative costs of participation, over other episode-based payment setting. Therefore, we are using HOPD and have absolute scoring and setting or programs. thresholds for payment linked to quality Response: We believe that the RO payment rates to create the RO Model measures. Model will best meet its objectives of national base rates. For a detailed Response: We have addressed these delivering site-neutral payments for discussion of this Model’s Pricing comments throughout the applicable included radiation therapy modalities Methodology see section III.C.6 of this sections of this final rule, including in, through episode-based payments rather final rule. but not limited to, sections III.C.6., C.6.f, than total-cost-of-care because radiation Comment: A commenter stated that and C.8. of this final rule. oncology is highly technical and CMS does not have authority to Comment: A commenter expressed furnished in well-defined episodes, and implement site-neutral payments and is concern for overall payment stability because patient comorbidities generally using section 1115A to adopt a policy because disruptions to payment may do not influence treatment delivery preference that CMS otherwise could have unintended consequences such as decisions. We also believe that not adopt. the closure of radiotherapy centers providers and suppliers will not Response: We disagree with this which could result in a loss of access to compromise their patients’ safety or commenter, and believe that we are care for Medicare beneficiaries. deviate from the standard practice of operating within our authority. Section Response: One of the objectives of this care in an attempt to ‘‘game’’ the system. 1115A of the Social Security Act Model is to provide site-neutral, more We believe that the monitoring and authorizes the Secretary to test predictable payments to RO compliance requirements will mitigate innovative payment and service participants. We believe that the gaming by RO participants. In addition, delivery models expected to reduce payment methodology as finalized in we believe that there are sufficient program expenditures while preserving section III.C.6. of this final rule safeguards in place to prevent providers or enhancing the quality of care accomplishes this goal of providing and suppliers from engaging in acts that furnished to Medicare, Medicaid, and more predictable or foreseeable will harm their patients, including but Children’s Health Insurance Program payments to RO participants. We further not limited to the requirements to (CHIP) beneficiaries. Section 1115A(b) believe that having more predictable actively participate with an AHRQ- provides a non-exhaustive list of models payments may mitigate closures of listed patient safety organization (PSO) to be tested. Under this authority, CMS viable radiotherapy centers. and provide Peer Review (audit and has broad discretion to design its Additionally, we will be monitoring for feedback on treatment plans) (see payment and service delivery models. beneficiary access issues throughout the section III.C.14). For more discussion about CMS’ Model (see section III.C.14). Comment: Several commenters statutory authority to conduct the RO Comment: A few commenters raised requested that the site neutral payment Model under section 1115A of the Act, concerns that the lack of telehealth policy be abandoned. A few please reference section III.C.3.a of this discussion in this Model meant that commenters stated that a site neutral final rule. such connected health technologies payment approach assumes that care is Comment: A few commenters would not have a role in the RO Model. equivalent in all settings. A commenter requested that we abandon the proposal A commenter requested that CMS argued that the site neutral policy to have site-neutral payments because utilize every opportunity to remove ignores the higher cost of providing different sites of care have different barriers to the use of advanced services in an HOPD setting as operating costs.

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Response: We believe that site-neutral payment continue to be made on a fee- require providers and suppliers to payment is a necessary component of for-service basis, with a reduction in the upgrade their technology to provide the RO Model test to avoid establishing reimbursement for fractions that are lower and more precise fractions of RT. an incentive for RO participants to beyond the average for a particular For this reason, the commenter deliver RT services in one setting over diagnosis. recommended that CMS publish the another, even though the actual Response: The commenters’ suggested science underlying its belief that treatment and care received by Medicare approach, as we understand it, would hypofractionation would be appropriate beneficiaries for a given modality is the require ongoing adjustments to fee-for- for this range of cancer types. same in both settings. service payments based on changing A commenter shared specific Comment: A commenter stated that averages for a particular diagnosis. We recommendations and evidence for RT the proposed RO Model’s site-neutral believe that the proposed prospective hypofractionation in breast cancer, payments do not go far enough and that episode-based payment tested under prostate cancer, head and neck cancer, these payments should be applied to all this Model would be preferable as this and Central Nervous System (CNS) providers and suppliers, regardless of approach will test whether a modality cancers, as well as in bone and brain the Core-Based Statistical Areas agnostic, bundled payment will lead to metastases. (CBSAs) in which they furnish RT more appropriate courses of radiation A commenter emphasized that services. This commenter also does not treatment for certain cancer types. hypofractionated treatments may believe that a 5-year test is necessary to Comment: A commenter urged CMS increase acute toxicity and that patients conclude that payment rates for RT to establish policies that encourage with pre-existing conditions like services under the OPPS and MPFS participants’ investment in care ulcerative colitis or collagen-vascular should be equalized. transformation to achieve the agency’s disorder are poor candidates for these Response: We agree that payment long-term goal of improving quality of types of hypofractionated treatments. rates under the RO Model should be care while reducing costs. Response: We thank the commenters site-neutral, and are proceeding with the Response: We believe that this Model for this information. It was not CMS’ 5-year test of this Model, with CBSAs embraces our goal of improving quality intent to encourage hypofractionation selected for participation to understand of care while reducing costs (see section specifically. It was our intent to use the impact of site-neutral payments on III.C.14 of this final rule for the Model’s hypofractionation as an example of a cost and quality of care. We believe that monitoring and compliance treatment option often cited in the Model performance period of 5 requirements). We also believe that this nationally recognized, evidence-based years, as opposed to a shorter duration, Model, as finalized, will encourage RO guidelines. We rely on Medicare is necessary to obtain sufficient data to participants to transform their care. providers and suppliers to furnish compute a reliable impact estimate and Comment: A commenter voiced appropriate care to our beneficiaries. As to analyze the data from the Model to concern that participants with fewer finalized in section and III.C.14 and determine next steps regarding potential resources would attempt high dose III.C.16, we will monitor for unintended expansion or extension of the Model. hypofractionation without adequate consequences of the RO Model, and Further, we believe that a test period of equipment and that the proposed rule such monitoring could include 5 years is necessary to address and did not have a mechanism in place to utilization patterns regarding fractions. mitigate any potential implementation test the ‘‘fitness’’ of the Comment: A commenter expressed issues or unintended consequences. For hypofractionation equipment. concern with the high cost of treating a discussion of the Model performance Response: At this time, we are unable patients in a rural treatment facility. period, please see section III.C.1. of this to perform such a test as we do not Response: We believe that the policies final rule. believe that testing equipment falls as finalized in this final rule will help Comment: A commenter requested within the Innovation Center’s authority to address this commenter’s concerns. clarification on how the RO Model will to test payment and service delivery In particular, we refer readers to section impact the budget neutrality models. However, we will be using Peer III.C.3.c of this final rule for the optional requirements under the OPPS and PFS. Review and patient surveys, among opt-out for low-volume RO participants, Response: With respect to the budget other monitoring measures (see section as well as section III.C.3.d that describes neutrality requirements under the III.C.14 of this final rule), to assess how CBSAs exclude extreme rural Medicare Physician Fee Schedule (PFS) whether RO participants are engaging in geographic areas, and section III.C.3.c and Outpatient Prospective Payment such egregious behaviors. that discusses the exclusion of critical System (OPPS), absent any further Comment: A few commenters access hospitals. adjustment, we would expect the RO discussed concerns with Comment: A commenter expressed Model to pull utilization out of the hypofractionation. These commenters the desire to maintain current traditional fee-for-service payment generally noted that data supporting valuations for Radiation Therapy G- systems. The Center for Medicare will fractionation is limited across cancer codes under the PFS (HCPCS Codes monitor this issue through the duration types. A commenter used prostate G6001, G6002, G6003, G6004, G6005, of the Model test and account for cancer as an example, concluding that G6006, G6007, G6008, G6009, G6010, utilization for services included in the the RO Model might make G6011, G6012, G6013, G6014, G6015, RO Model under the PFS and OPPS as hypofractionated treatment the only G6016 and G6017), and requested that appropriate. In essence, we believe that economically viable option for treating these valuations be stable throughout this Model will, in time, reduce program men with low- and intermediate-risk the Model. expenditures while preserving or prostate cancer. This commenter Response: The purpose of the RO enhancing the quality of care furnished believed such a move would be Model is to test whether prospective to beneficiaries. premature, as the benefits of episode payments in lieu of traditional Comment: A couple of commenters hypofractionation for prostate cancer are FFS payments for RT services would opposed paying for radiotherapy unclear. reduce Medicare expenditures and services based on the proposed Another commenter highlighted that preserve or enhance quality of care for prospective payment approach in the testing whether hypofractionation beneficiaries. Additionally, the RO RO Model, and instead suggested that lowers costs and improves quality will Model is designed to test a site-neutral

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and modality agnostic approach to 31, 2024, we proposed that no new renewed, effective July 25, 2020, the payment for RT services. Therefore, we episodes may begin after October 3, determination that a PHE exists which do not believe that continuing to make 2024. We solicited public comments on he had previously renewed on April 21, payment based on the current the Model performance period and 2020. valuations for certain G-codes under the potential participants’ ability to be In light of this unprecedented PHE, PFS aligns with the intent of this Model ready to implement the RO Model by which continues to strain health care test. Please refer to section III.C.5.c of January 1, 2020. We also solicited resources, we are finalizing the RO this final rule for a discussion of our comments on delaying the start of the Model’s Model performance period to included RT services as well as section Model performance period to April 1, begin on January 1, 2021. We III.C.6 for details regarding the specific 2020. The following is a summary of understand that RO participants may RO Model codes that will be used comments received on these proposals have limited capacity to meet the RO during this Model and how their value and our responses: Model requirements in 2020. To ensure will be calculated in each performance Comment: Many commenters that participation in the RO Model does year. provided feedback related to the not further strain RO participants’ Model’s start date for the RO Model. C. RO Model Regulations capacity, potentially hindering the Almost all of the commenters were delivery of safe and efficient health care In the proposed rule at 84 FR 34493, opposed to the RO Model beginning on to beneficiaries receiving RT services, we discussed our policies for the RO January 1, 2020. Some commenters we are finalizing the RO Model’s Model Model, including model-specific recommended that CMS consider performance period to begin on January definitions and the general framework delaying the implementation of the 1, 2021. for implementing the RO Model. We Model until the alternatively proposed We also believe that finalizing the defined ‘‘performance year’’ (PY) as the date of April 1, 2020, but many still Model performance period to begin 12-month period beginning on January 1 believed that this date would not allow January 1, 2021 will give RO and ending on December 31 of each year sufficient time to prepare. Commenters participants sufficient time to learn and during the Model performance period. believed the April 1, 2020 Model’s start understand the RO billing requirements, We proposed to codify the term date fell short of providing adequate train staff on new procedures, prepare to ‘‘performance year’’ at § 512.205 of our preparation time for RO participants report on quality measures and clinical regulations. and proposed alternative start dates of In the proposed rule, we included our data elements, evaluate and adjust their late spring or early summer of 2020; July budgets to prepare for the RO Model, proposed policies for each of the 1, 2020; August 1, 2020; October 1, following: (1) The scope of the RO and to allow EHR vendors to begin to 2020; and January 1, 2021. Commenters develop mechanisms to comply with the Model, including the RO participants, recommended a delay from when the Model. beneficiary population, and episodes RO Model is finalized or when the Therefore, we are finalizing our that would be included in the test; (2) CBSAs selected for participation are proposed Model performance period at the pricing methodology under the announced to when it would begin; a § 512.205, with the modification that the Model and the Medicare program policy couple of commenters recommended a Model performance period begin on waivers necessary to implement such 6-month delay, some commenters methodology; (3) the measure selection requested a 9-month delay, and a few January 1, 2021, where each PY will for the Model, including performance commenters recommended a 12-month consist of a 12-month period beginning scoring methodology and applying delay. on January 1 and ending on December quality to payment; (4) the process for Response: We appreciate these 31. For all episodes to be completed by payment reconciliation; and (5) data commenters’ concerns. Regarding December 31, 2025, we are finalizing collection and sharing. commenters’ use of the term that no new RO episodes may begin In the proposed rule, we discussed ‘‘implementation date,’’ we understand after October 3, 2025. The 5-year codifying RO Model policies at 42 CFR commenters are referring to the performance period will run from part 512, subpart B (§§ 512.200 through beginning of the Model performance January 1, 2021, through December 31, 512.290). In addition, as we explained period. After reviewing these concerns, 2025. in section II. of the proposed rule, the we agree with commenters that both the Comment: One commenter general provisions codified at January 1, 2020 and April 1, 2020 start recommended that CMS issue an §§ 512.100 through 512.180 would dates would not provide RO Interim Final Rule with comment apply to the RO Model. participants with sufficient time to period, identify the selected RO Model operationalize the RO Model participants in the Interim Final Rule, 1. Model Performance Period requirements. We intended to start the and ensure selected participants have at We proposed to test the RO Model for RO Model on July 1, 2020, but as we least six months of advanced notice five PYs. We proposed to define ‘‘Model were completing this final rule, the before the RO Model begins. performance period’’ to mean January 1, United States began responding to an Response: An interim final rule with 2020, the date the Model begins, outbreak of respiratory disease, referred comment period (‘‘IFC’’) would be through December 31, 2024, the last to as ‘‘Coronavirus disease 2019’’, which inappropriate for purposes of finalizing date during which episodes under the created a serious public health threat the RO Model, as the proposed rule for Model must be completed (84 FR greatly impacting the U.S. health care the RO Model was published July 18, 34493). Alternatively, we also system. The Secretary of the Department 2019 (84 FR 34478). Further, we believe considered delaying implementation to of Health and Human Services, Alex M. the selected RO participants will have April 1, 2020 to give RO participants Azar II, declared a Public Health sufficient time to prepare for a Model and CMS additional time to prepare. As Emergency (‘‘PHE’’) on January 31, performance period that begins January we discussed, an April 2020 start date 2020, retroactively effective from 1, 2021. To ensure that RO participants would only affect the length of PY1 January 27, 2020, to aid the nation’s have sufficient preparation time, we are which would be 9 months. All other healthcare community in responding to publishing this final rule more than 60 PYs would be 12 months. For all the Coronavirus disease 2019 pandemic. days prior to the beginning of the Model episodes to be completed by December On July 23, 2020, Secretary Azar performance period.

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Comment: Many commenters stated other participants need time to plan for on January 1, 2021 will provide that RO participants would face budget requests and approvals relating adequate time for RO participants to considerable administrative burden, and to equipment upgrades and IT support. prepare for the RO Model and to modify would not have the appropriate time to Based on these concerns and the PHE, their operations to meet the Model plan for implementation until the final we are finalizing the Model performance requirements. The Medicare rule was issued—noting that 60 days or period to begin on January 1, 2021. The Administrative Contractors in the fewer would be insufficient. These Model requirements, including measure CBSAs selected for participation will be commenters identified many reasons for data collection and the use of certified prepared when the Model begins on requesting more time, including that EHR technology (CEHRT), will begin in January 1, 2021. EHR vendors would need ample time to PY1 (which begins on January 1, 2021). Comment: Many commenters design, develop, build, test, validate, We believe that the period of time requested more time to implement the and implement the software to allow RO between publication of this final rule RO Model, because RO participants participants to fulfill the requirements and the beginning of the Model would need adequate time to of the RO Model in a streamlined performance period will provide EHR operationalize the RO Model’s coding manner through their EHR platforms. vendors with sufficient time to and billing requirements. Many Some of these commenters specified implement the software that RO commenters stated that they would need that it could take 12 to 18 months for participants may need to adhere to the to hire additional staff, and to train and EHR vendors to complete software RO Model requirements. educate new and existing staff and development cycles. A few commenters Comment: Many commenters stated clinicians on RO Model procedures, pointed out that successful that RO participants would need requirements, billing and other systems. implementation of the RO Model would adequate time to prepare for the new A few commenters stated that they require many RO participants as well as reporting of quality measures and would need sufficient time to educate software vendors to change EHR clinical data required by the RO Model. and engage clinical and operational staff configurations, organizational policies, These commenters stated that they about the RO billing practices and and end user workflows. A commenter would need considerable time to processes, and for these participants to stated that radiation oncology develop and build a specific clinical learn and understand changes to coding, departments utilize specific electronic infrastructure to meet the increased claims generation, claims processing, medical record and record-and- quality data collection and reporting participant-specific modifiers and verification systems that are linked to requirements mandated by the RO adjustments, withhold calculations, and their linear accelerators, and the Model. A commenter emphasized that payment programming. A couple of vendors that support those information such a delay would be particularly commenters expressed concern about systems would not be prepared for important for those RO participants the administrative burden of learning a implementation in January 2020. A treating Medicare beneficiaries with new billing system under the RO Model commenter also stated that hospitals prostate, breast, or lung cancers as well while simultaneously maintaining a and other participants need time to plan as bone and brain metastases, given separate billing system for privately for budget requests and approvals CMS’ proposal to require those insured patients. One of these relating to equipment upgrades and IT participants to collect and report commenters stated that the billing staff support. A few commenters expressed clinical information not currently would be burdened with the need to available in claims or captured in the identify which patients are in the Model concern that EHR vendors would need proposed quality measures. and which are not in order to to develop and implement complicated Response: We understand appropriately bill claims because the changes to collect information on commenters’ concerns that they will billing would differ significantly for clinical data elements in a short period need considerable time to develop and each patient and insurer. Many of time because CMS has yet to publish build a specific clinical infrastructure to commenters stated that RO participants the Model-specific clinical data meet the increased quality data would need more time to make elements. collection and reporting requirements budgetary accommodations to offset the Response: We agree with commenters’ mandated by the RO Model. We also perceived additional expenses related to concerns that EHR vendors will need understand that RO participants and participation in the RO Model and to re- more time to design, develop, build, Medicare contractors in the CBSAs evaluate practice budgets to test, validate, and implement the selected for participation would need accommodate for changes in cash flow software to allow RO participants to adequate time to prepare for the RO as a result of participation in the Model. fulfill the requirements of the RO Model Model requirements, and to successfully Response: We believe that finalizing in a streamlined manner through their modify operations. We believe that the Model performance period to begin EHR platforms. We understand that finalizing the Model performance period on January 1, 2021 will provide RO successful implementation of the RO on January 1, 2021 provides sufficient participants with sufficient time to Model will require many RO time for selected RO participants to prepare to meet the billing and coding participants as well as software vendors develop and build the necessary requirements, to re-evaluate practice to change EHR configurations, infrastructure to meet reporting budgets to accommodate for changes in organizational policies, and end user requirements of the RO Model. the Model, to hire new staff and educate workflows. We also understand that Comment: Many commenters existing staff, and to address concerns some radiation oncology departments requested that the RO Model be delayed regarding the administrative burden of utilize specific electronic medical so that RO participants and Medicare learning a new billing system under the record and record-and-verification contractors in the CBSAs selected for RO Model. The Model requirements, systems that are linked to their linear participation would have adequate time codified at § 512.220, will start on accelerators, and the vendors that to prepare for the RO Model January 1, 2021. support those information systems requirements, and to successfully For concerns regarding changes in would not have been prepared for modify operations. billing and coding requirements, we implementation in January 2020. We Response: We believe that finalizing believe that the finalized billing process further understand that hospitals and the Model performance period to begin that will be easily implemented within

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current systems because it is based on baseline measurement and preparation these reasons, we believe that a Model how FFS claims are currently period that would allow RO participants performance period of five years is submitted. Section III.C.7 of this final to make practice transformations; necessary, and we will not reduce the rule provides information on billing and change workflow; review, analyze, and Model performance period to less than coding changes under the RO Model. act on data received from CMS; five years. Additional guidance on billing and understand Model reporting We also would like to clarify that we coding will be made available to RO requirements; and receive additional proposed that the RO Model would participants before the beginning of the education from CMS on Model cover 40 percent of all eligible RO Model performance period through parameters and objectives. A couple of episodes in eligible CBSAs nationwide resources such as the Medicare Learning these commenters further suggested that in order to have a nationally Network (MLN Matters) publications, RO participants could submit no-pay representative sample of RT providers Model-specific webinars, and/or the RO claims for the PY0 episodes while and suppliers that is sufficiently large Model website. continuing their normal billing enough to confidently show the impacts Comment: A few commenters stated practices. of the Model within five years (84 that they would need to operationalize Response: We are finalizing the Model FR34496). As discussed in section the billing requirements of the RO performance period that will include III.C.3.d, we are finalizing a policy that Model in a shortened time frame, as performance years (PYs) one through includes 30 percent of all eligible RO they would not be notified of their five (PY1–PY5), and it will not include episodes in eligible CBSAs nationwide, selection until the publication of the a PY0. PY1 of the RO Model will begin and determined that we will still be able final rule. on January 1, 2021. We believe that to maintain confidence in estimating the Response: We believe that finalizing finalizing the Model performance period impacts of the RO Model. Finalizing a the Model performance period to begin to begin on January 1, 2021 makes a PY0 Model performance period to anything on January 1, 2021 will provide RO unnecessary because RT providers and less than five years would not allow us participants adequate time to RT suppliers will have several months to maintain that confidence necessary to operationalize the Model’s billing to prepare for the RO Model and its show the impacts of the RO Model. requirements which are based on the requirements. Regarding the commenters suggesting current FFS claims systems. Comment: A few commenters that the RO Model should be voluntary, Comment: A commenter stressed that recommended reducing the number of please reference section III.C.3.a of this it would take time to operationalize the performance years. A commenter final rule for further discussion of why beneficiary notification requirement. requested that the duration of the Model we believe a mandatory design is Response: We will provide RO Model be reduced to three years. This necessary for the testing of the RO participants with a beneficiary commenter stated that a reduction in Model. notification letter template that RO both duration and number of episodes, After considering public comments, participants may personalize with their coupled with voluntary participation, we are finalizing our proposal with contact information and logo. RO would provide sufficient information for modification to the Model performance participants must provide this CMS to assess the viability of the Model period. Specifically, we are revising the beneficiary notification letter to each and to then scale the Model nationally regulations at § 512.205 to define the beneficiary during the initial treatment if it had achieved its goals of improving Model performance period to mean planning session. We refer readers to care and reducing costs. January 1, 2021, through December 31, section III.C.15 of this final rule for Response: We proposed that the 2025, the last date during which RO details regarding the beneficiary performance period for the RO Model to episodes must be completed, with no notification letter. We do not believe be five performance years because at new RO episodes beginning after that the beneficiary notification letter, least five performance years are October 3, 2025, in order for all RO which will require minimal necessary to sufficiently test the episodes to be completed by December modification by the RO participant, will proposed prospective payment 31, 2025. We are also codifying at warrant significant additional time to approach, stimulate the development of § 512.205 that performance year (PY) operationalize. new evidence-based knowledge, acquire means the 12-month period beginning Comment: A commenter requested additional knowledge relating to on January 1 and ending on December additional time for participants to patterns of inefficient utilization of 31 of each year during the Model receive and review CMS data to better health care services, and to formulate performance period. understand their current care processes methods to incentivize the improvement and drive care transformation under the of high-quality delivery of RT services. 2. Definitions Model. Based upon our analyses we do not In the proposed rule, we proposed to Response: We plan to allow RO believe that three years will be sufficient define certain terms for the RO Model participants, to the extent permitted by to test the proposed payment approach. at § 512.205. We described these HIPAA and other applicable laws, to We believe that a Model performance proposed definitions in context request claims data from CMS for period of five years is necessary to throughout section III of the proposed purposes of care coordination and/or address implementation issues and for rule. In the proposed rule, we solicited quality improvement work. Please see the evaluation to obtain sufficient data public comments on our proposed section III.C.13.d for more information. to compute a reliable impact estimate, definitions. To the extent we have To request this data, RO participants and to determine next steps regarding received comments relating to the will submit a Participant Data Request potential expansion or extension of the definitions that we had proposed, we and Attestation (DRA) form, which will Model. Notably, the evaluation will have responded to those comments in be available on the Radiation Oncology analyze data on the impact of the Model context throughout section III of this Administrative Portal (ROAP). on an ongoing basis, so to the extent that final rule. Comment: A few commenters evaluation results are definitive sooner suggested that CMS include a than the end of the Model, we will 3. Participants performance year 0 (PY0) for the RO consider next steps at that time rather In the proposed rule, we discussed Model. This PY0 could serve as a than waiting until the Model ends. For how certain Medicare participating

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HOPDs, physician group practices Medicare payment policy. Therefore, we Response: We appreciate the (PGPs), and freestanding radiation proposed a broad representative sample commenter’s support. As explained in therapy centers that furnish RT services of RT providers and RT suppliers in the proposed rule (84 FR 34493 through (RT providers or RT suppliers) in Core- multiple geographic areas (see section 34496) and in this final rule, mandatory Based Statistical Areas (CBSAs) III.C.3.d of both the proposed rule and participation eliminates selection bias, randomly selected for participation, this final rule for a discussion regarding ensures participation from HOPDs, would be required to participate in the the Geographic Unit of Selection). We provides a representative sample of RT RO Model either as ‘‘Professional proposed the best method for obtaining providers and RT suppliers, and participants,’’ ‘‘Technical participants,’’ the necessary diverse, representative facilitates a comparable evaluation or ‘‘Dual participants’’ (as such terms group of RT providers and RT suppliers comparison group. We maintain that the are defined at 84 FR 34494). We defined would be random selection. This is mandatory design for the RO Model is ‘‘RO participant’’ at § 512.205 of the because a randomly selected sample necessary to enable CMS to detect proposed rule as a PGP, freestanding would provide analytic results that will change reliably in a generalizable radiation therapy center, or HOPD that be more generally applicable to all sample of RT providers and RT participates in the RO Model pursuant Medicare FFS RT providers and RT suppliers to support a potential model to the criteria that we proposed to suppliers and would allow for a more expansion. establish at § 512.210 (see section robust evaluation of the Model. Comment: A few commenters stated III.C.3.b in the proposed rule and in this In addition, in the proposed rule at 84 that the mandatory nature of the RO final rule). In addition, we noted that FR 34493 through 34494, we discussed Model would force some RT providers the proposed definition of ‘‘model actuarial analysis suggesting that the and RT suppliers to participate in the participant,’’ includes an RO difference in estimated price updates for Model that are not operationally ready participant. In the proposed rule, we rates in the OPPS and PFS systems from while at the same time excluding others discussed our proposals regarding 2019 through 2023, in which the OPPS that are well prepared. This could create mandatory participation, the types of rates are expected to increase challenges for beneficiary access and entities that would be required to substantially more than PFS rates, could lead to operational issues for participate, and the geographic areas would result in few to no HOPDs practices. that would be subject to the RO Model electing to voluntarily participate in the Response: Mandatory participation test. Model. Further, those actuarial and random selection of participants are estimates suggested that freestanding integral to the design and evaluation of a. Required Participation radiation therapy centers with this Model. However, we believe that In the proposed rule (84 FR 34493 historically lower RT costs compared to finalizing the Model performance period through 343494), we discussed how the national average would most likely to on January 1, 2021 will allow RT certain RT providers and RT suppliers choose to participate, but those with providers and RT suppliers sufficient that furnish RT services within CBSAs historically higher costs would be less time to prepare for the RO Model’s randomly selected for participation likely to voluntarily participate. We requirements. would be required to participate in the discussed how requiring participation Comment: Some commenters stated RO Model (as discussed in sections in the RO Model would ensure that mandatory participation would III.C.3.b and III.C.3.d of this final rule). sufficient proportional participation of have negative consequences on To date, the Innovation Center has both HOPDs and freestanding radiation Medicare beneficiaries, such as tested one voluntary prospective therapy centers, which is necessary to depriving beneficiaries of their freedom episode payment model, Bundled obtain a diverse, representative sample to choose where they receive RT Payments for Care Improvement (BPCI) of RT providers and RT suppliers and to services, reducing access to care, and Model 4 that attracted only 23 help support a statistically robust test of increasing financial and logistical participants, of which 78 percent the prospective episode payments made burdens for beneficiaries that believe withdrew from the initiative. In the under the RO Model. they need to travel outside of their proposed rule, we discussed our interest For these reasons, we believed that a CBSA to receive care from a non-RO in testing and evaluating the impact of mandatory model design would be the participant. a prospective payment approach for RT best way to improve our ability to detect Response: We would like to clarify services in a variety of circumstances. and observe the impact of the that the RO Model will not interfere We stated our belief that by requiring prospective episode payments made with the general guarantees and the participation of RT providers and under the RO Model. Therefore, we protections for all Medicare FFS RT suppliers, we would have access to proposed that participation in the RO beneficiaries. We support Medicare more complete evidence of the impact Model would be mandatory for all RT beneficiaries’ rights to seek care of the Model. providers and RT suppliers furnishing wherever they choose, and we are As discussed in the proposed rule, we RT services within the CBSAs randomly codifying at § 512.120(a)(1) the believe a representative sample of RT selected for participation (84 FR 34493 requirement that RO participants not providers and RT suppliers for the through 34494). restrict a beneficiary’s ability to choose proposed Model would result in a We solicited public comments on our his or her provider(s) and/or supplier(s). robust data set for evaluation of this proposal for mandatory participation. Further, we are using CBSAs as the unit prospective payment approach, and The following is a summary of of selection for the RO Model. We would stimulate the rapid development comments received on this proposal and selected CBSAs, as opposed to larger of new evidence-based knowledge (84 our responses to these comments: geographic units of selection, in order to FR 34493). Testing the Model in this Comment: CMS received many allow beneficiaries to travel to another manner would also allow us to learn comments related to the proposed area to receive RT services, if they so more about patterns of inefficient mandatory participation of the Model. wished. utilization of health care services and One commenter agreed with CMS’ Comment: A couple of commenters how to incentivize the improvement of decision to make participation in this stated that mandatory participation is a quality for RT services. This learning Model mandatory for CBSAs randomly departure from the agency’s previous could potentially inform future selected for participation. approach to model participation, and

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these commenters believed that CMS hardship for participating practices; a prior to applying the discount factor and had previously indicated that disproportionate effect on cancer withholds, payments under the Model mandatory models would only be used centers with a predominantly Medicare will be between 90 and 100 percent of judiciously or when the agency could patient base; Medicare patients being the RO participant’s historical not guarantee enough participation or exposed to unnecessary excess payments. For historically inefficient would have an adverse selection for radiation; stifled innovation; and a RO participants, the blend shifts over voluntary models. decrease in overall quality of care. time to a 70/30 blend in PY5. For Response: We believe that the RO Response: We will conduct ongoing historically efficient RO participants, Model meets these circumstances. As monitoring and evaluation analyses to the blend for the Model performance discussed throughout this section and in watch for any unintended consequences period is fixed at 90/10 blend. Section III.C.3.d, we designed the RO of the Model, as finalized in section Regarding the comment that the Model to require participation by RT III.C.16. Please also refer to sections mandatory nature of the RO Model will providers and RT suppliers in order to III.C.3.d. and III.C.14 of this final rule result in a decrease in overall quality of avoid selection bias. Further, as for more discussion about how we will care, we disagree. We specifically discussed earlier in this section, our monitor for unintended consequences designed the Model to preserve or actuarial analysis suggests that without under the RO Model. enhance quality of care, and we are mandatory participation in the RO Specifically regarding the comment putting in place measures, like the Model, there will be limited to no about Medicare patients being exposed collection of quality measures and participation from HOPDs. to unnecessary excess radiation, we rely clinical data elements, to help us to Comment: Some commenters on Medicare providers and suppliers to quantify the impact of the RO Model on expressed concerns that the proposed furnish appropriate care to our quality of care. See section III.C.8 of this mandatory participation would lack beneficiaries. As for concerns regarding final rule for more information upside opportunity for high-performing stifled innovation under the RO Model, regarding our finalized provisions for participants and lead to hospitals and we believe these concerns will be the quality measures and clinical data health systems bearing the expense of mitigated by the fact that new elements that will be collected for the participation in a complicated program technologies, upon receiving an RO Model. and the burden of generating all of the assigned HCPCS code, would be paid Comment: Many commenters identified savings associated with the FFS until such time that they could be suggested that participation in the Model. proposed for the RO Model through Model be voluntary, or that participants Response: We would like to note that future rulemaking. We also believe these have the option to opt-in or opt-out of the RO Model is an Advanced APM and concerns about stifled innovation under the Model. Many commenters provided a MIPS APM. As such, eligible the RO Model will be mitigated by the operational suggestions should the clinicians who are Professional trend factor, which will reflect updates Model be voluntary, including that participants and Dual participants may to input prices as reflected in updated participants could choose to participate potentially become Qualifying APM PFS and OPPS rates. Please refer to for the entirety of the Model Participants (QPs) who earn an APM section III.C.6 of this final rule for performance period. Many commenters Incentive Payment and are excluded further discussion about this. referenced other voluntary models, from the MIPS reporting requirements We do not believe that RO namely the Bundled Payments for Care and payment adjustments. Under the participants will be at a competitive Improvement Advanced (BPCI current Quality Payment Program rules, disadvantage, or subject to uncertain Advanced) Model and the Oncology those who are not excluded from MIPS pricing, because the RO Model pricing Care Model (OCM), and suggested that as QPs or Partial QPs will receive a final methodology employs a trend factor, these models have significant health score and payment adjustment under which is applied to an established care provider interest and participation, MIPS, unless otherwise excepted. We national base rate, that is based on and have demonstrated that the RO believe these aspects of the RO Model updated PFS and OPPS rates and Model could be successful and garner as an Advanced APM and a MIPS APM ensures that spending under the RO sufficient participation as a voluntary will provide eligible participants with Model will not diverge too far from model. The commenters suggested that an example of the upside opportunity spending under the FFS that non- a voluntary model would provide an for high-performing participants under participants will receive for the opportunity to mitigate unintended the Model stated by the commenters. underlying bundle of services had they consequences prior to expanding to a The RO Model also affords all RO been in the Model. See section III.C.6.d mandatory model. Many commenters participants the opportunity to actively for more information. stated that making the RO Model participate in the effort of moving Regarding the comment that the voluntary would reduce the potential toward and incentivizing value-based Model would have a disproportionate risk, disruption, and financial hardships RT care, offering to make certain data effect on cancer centers with a to RO participants. available that RO participants can predominantly Medicare patient base, As an alternate recommendation, request for use in care coordination and we disagree. Episode payments will be many commenters suggested that the RO quality improvement, which would largely determined by what an RO Model have a ‘‘phase in’’ period for potentially increase beneficiary participant was historically paid. As participants such that the Model would satisfaction. described in section III.C.6, the pricing begin as voluntary and transition to Comment: Many commenters methodology as finalized will blend mandatory participation in subsequent suggested that other unintended together the national base rate with an years. One of these commenters consequences could result from RO participant’s unique historical recommended voluntary participation mandatory participation in the RO experience. If the RO participant is for the initial two of five performance Model. These commenters listed the historically less efficient than the years, and then phase in mandatory following potential consequences: A national average, the blend in PY1 will participation over the remaining 3-year competitive disadvantage for be 90 percent of the RO participant’s period. Another commenter participants who are subject to new and historical payments and 10 percent of recommended voluntary participation uncertain pricing; unfair financial the national base rate. This means that for the first performance year (PY) with

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a transition to limited mandatory opportunity for success and ensure comparison group not exposed to the participation in the subsequent accurate and useful results from the intervention improves our ability to performance years. Another commenter Model. Another commenter believed make causal inferences. A time series recommended voluntary participation this process would allow practices to analysis is only necessary in with a gradual phase in of additional transition to the coding and billing circumstances when a comparison participants through expansion of the requirements and allow time to build group does not exist, and under the RO Model by 10 percent each year. infrastructures to collect data. A couple Model, a control group of Another commenter suggested that of commenters stated that this approach nonparticipants will exist. providers and suppliers in the selected would support CMS’ objectives, as well While we will not allow for voluntary geographic areas be allowed to opt out as allow CMS to build the infrastructure participation for the Model, after of participation in the first year of the to administer this program effectively considering the concerns raised by the Model, and that CMS remove downside and to then scale it as additional commenters, including potential risk for those that do participate. Then, participants joined. A few commenters financial hardship for practices under in the remaining four years of the suggested that this approach would be the RO Model, we are modifying the Model, all providers and suppliers in more consistent with the processes that proposed policy to include an opt-out the selected geographic areas would be previous CMS models have followed. option for RT providers and RT required to participate with two-sided One of these commenters stated that this suppliers that are low volume (see risk. A few commenters recommended approach would provide participants section III.C.3.c of this final rule for that CMS initiate the Model on a with more feasible pathways to value- additional information). While we voluntary basis with little to no risk, based payment by allowing for appreciate the commenters’ suggestions and then transition to a risk-based flexibility and time to adjust practice to employ a phase in process for the RO Model with opt-in and opt-out patterns to best meet the Model’s Model, we believe that allowing a phase provisions to take place over a period of requirements. Another commenter in process for participants would create time. These commenters compared this stated that this process would be fairer a selection bias in the early years of the suggested risk approach to those to providers and suppliers that are Model that would hinder robust implemented in both the currently unprepared to participate, and evaluation. As we stated in the Comprehensive Care for Joint would avoid penalties on participants proposed rule and in this final rule, Replacement (CJR) Model and OCM. A that are unequipped to provide value- actuarial analysis suggests that the few commenters recommended that based care and require additional time difference in estimated price updates for CMS consider a voluntary Model for the to prepare a plan for a successful rates in the OPPS and PFS systems from first four years with incentives for transformation. 2019 through 2023, in which the OPPS participants, and then subsequently Response: We appreciate commenters’ rates are expected to increase transition to a limited mandatory suggested alternatives to mandatory substantially more than PFS rates, Model. Another commenter suggested participation for the RO Model. would result in few to no HOPDs that the RO Model be voluntary for the However, as explained in the proposed electing to voluntarily participate in the initial three years, and then move to rule (84 FR 34493 through 34496) and Model. These actuarial estimates also mandatory in PY4 and PY5. in this final rule, we believe that if the suggest that freestanding radiation Many commenters recommended that Model is voluntary for all RT providers therapy centers with historically lower the Model have voluntary participation and RT suppliers or allow for a phased- RT costs compared to the national throughout the Model performance in approach, then we will face average would most likely choose to period. A commenter recommended complications in our ability to participate, but those with historically testing multiple small-scale voluntary accurately evaluate the RO Model. higher costs would be less likely to models with differing payment Regarding the comment about volunteer to participate. Therefore, we methodologies simultaneously to voluntary participation with a 10 believe that requiring participation in determine which approach would have percent reimbursement lift to allow the RO Model, without a voluntary the greatest impact with the fewest participants to ramp up for the program phase in option, is necessary to ensure unintended consequences. This and have the internal administrative sufficient proportional participation of commenter recommended that these and clinical operations necessary to both HOPDs and freestanding radiation tests be conducted with interested RT support and succeed in the Model, we therapy centers, and obtain a diverse, providers and RT suppliers before CMS believe, although we are not sure as representative sample of RT providers scaled it to the size proposed in the more detail was not provided by the and RT suppliers that will allow a NPRM. Another commenter suggested commenter, that the commenter is statistically robust test of the implementing the Model nationally as a suggesting that payments be increased prospective episode payments made voluntary model and utilizing the for participants by 10 percent. We under the RO Model. approach of evaluating the impact would like to note that we would not be Comment: Some commenters through an interrupted time series able to maintain or reduce costs under questioned CMS’ statutory authority to approach rather than a control group. A this type of design. implement the RO Model using section commenter recommended voluntary Regarding the comment suggesting 1115A of the Act. A few of these participation with a 10 percent that we implement the Model nationally commenters stated that the proposal reimbursement lift to allow participants as a voluntary model and utilize the requiring mandatory participation of to ramp up for the program and have the approach of evaluating the impact approximately 40 percent of radiation internal administrative and clinical through an interrupted time series oncology episodes represents a major operations necessary to support and approach rather than a control group, as policy change, and not a test of payment succeed in the Model. discussed throughout this section of the and service delivery models, which is These commenters provided a variety final rule, we maintain that the what CMS is authorized to do in section of reasons for their recommendations of mandatory design for the RO Model is 1115A of the Act. A few commenters a voluntary, phase in approach to the necessary. We have decided not to use stated that Innovation Center models RO Model. A commenter believed this an interrupted time series design for the should be implemented on a voluntary approach would promote an equitable RO Model because the use of a basis as the statute does not authorize

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CMS to mandate participation in any requirements as to spending and went into detail about the provisions of Innovation Center model, and any quality. Although section 1115A(b) of the proposed RO Model, enabling the agency interpretation that the statute the Act describes a number of payment public to understand how the proposed permits mandatory models raises issues and service delivery models that the Model was designed and could apply to of impermissible delegation of Secretary may choose to test, the affected RT providers and RT suppliers. lawmaking authority where none was Secretary is not limited to those models. As permitted by section 1115A of the intended and is inconsistent with the Rather, as specified in section Act, we are testing the RO Model within expressed mandate of section 1115A. A 1115A(b)(1) of the Act, models to be specified limited geographic areas. The commenter stated that making the tested under section 1115A of the Act fact that the Model will require the Model a mandatory requirement could must address a defined population for participation of certain RT providers be found potentially unlawful and is which there are either deficits in care and RT suppliers does not mean it is not unprecedented. A commenter surmised leading to poor clinical outcomes or a Phase I Model test. If the Model test that the RO Model was not developed potentially avoidable expenditures. meets the statutory requirements for by the Innovation Center, that the Here, the RO Model addresses a defined expansion, and the Secretary determines Secretary does not have the authority to population (FFS Medicare beneficiaries that expansion is appropriate, we would waive Medicare provisions or any who receive included RT services) for undertake rulemaking to implement the requirements of the Medicare statute which there are potentially avoidable expansion of the scope or duration of under the RO Model, and that the RO expenditures (arising from the lack of the Model to additional geographic Model violates section 3601 of the site neutrality for payments, incentives areas or for additional time periods, as Patient Protection and Affordable Care that encourage volume of services over required by section 1115A(c) of the Act. Act (‘‘the ACA’’). the value of services, and coding and Furthermore, we wholeheartedly Response: We disagree with these payment challenges in the PFS). We disagree that the RO Model is in commenters. The Innovation Center designed the RO Model to require violation of section 3601 of the ACA. designed and developed the RO Model, participation by RT providers and RT Section 3601 of the ACA requires that and we will be testing the RO Model, suppliers in order to avoid the selection nothing in the provisions of or consistent with section 1115A of the bias inherent to any model in which amendments to the ACA, including Act. We believe that we have the legal providers and suppliers may choose models being designed and tested by the authority to test the RO Model and to whether or not to participate. Such a Innovation Center, may result in a require the participation of all RT design will ensure sufficient reduction of guaranteed Medicare providers and RT suppliers in the proportional participation of both benefits. The RO Model is designed not CBSAs selected for participation, and HOPDs and freestanding radiation to result in a reduction of guaranteed that this does not constitute an therapy centers, which is necessary to Medicare benefits, and in fact as impermissible delegation of lawmaking obtain a diverse, representative sample finalized in section II.D.2 and codified authority that is inconsistent with of RT providers and RT suppliers that at § 512.120(b)(1), we are specifically section 1115A of the Act. First, we note will allow a statistically robust test of requiring RO participants to continue to that the RO Model will not be the first the prospective episode payments made make medically necessary covered Innovation Center model that requires under the RO Model. We believe this is services available to beneficiaries to the participation under the authority of the most prudent approach for the extent required by law. Further, we will monitor compliance with the Model section 1115A of the Act; we refer following reasons. Under the mandatory readers to the Comprehensive Care for requirements through monitoring RO Model, we will test and evaluate a Joint Replacement (CJR) Payment Model activities that may include Model across a wide range of RT for Acute Care Hospitals Furnishing documentation requests sent to RO providers and RT suppliers, Lower Extremity Joint Replacement participants and individual representing varying degrees of Services Final Rules, and the Home practitioners on the individual experience with episode payment. The Health Prospective Payment System practitioner list; audits of claims data, information gained from testing the (HHPPS) Final Rules implementing the quality measures, medical records, and mandatory RO Model will allow CMS to Home Health Value-Based Purchasing other data from RO participants and comprehensively assess whether RO (HHVBP) Model. Hospitals in selected clinicians on the individual practitioner episode payments are appropriate for a Metropolitan Statistical Area (MSAs) list; interviews with members of the were required to participate in the CJR potential expansion in duration or staff and leadership of the RO Model beginning in April 2016, and scope, including on a nationwide basis. participants and clinicians on the home health agencies in selected states Thus, the RO Model meets the criteria individual practitioner list; interviews were required to participate in the required for Phase I model tests. with beneficiaries and their caregivers; HHVBP Model beginning in January Moreover, the Secretary has the site visits; monitoring quality outcomes 2016. authority to establish regulations to and clinical data, if applicable; and We believe that both section 1115A of carry out the administration of tracking patient complaints and appeals. the Act and the Secretary’s existing Medicare. Specifically, the Secretary has Please see section III.C.14 of this final authority to operate the Medicare authority under sections 1102 and 1871 rule for further discussion on program authorize us to finalize of the Act to implement regulations as monitoring activities. mandatory participation in the RO necessary to administer Medicare, After considering public comments, Model as we have proposed. Section including testing this Medicare payment we are finalizing our proposal for 1115A of the Act authorizes the and service delivery model. We note mandatory participation with Secretary to test payment and service that the RO Model is not a permanent modification. Specifically, we are delivery models intended to reduce feature of the Medicare program; the codifying at § 512.210(a) that any Medicare costs while preserving quality Model will test different methods for Medicare-enrolled PGP, freestanding of care. The statute does not require that delivering and paying for services radiation therapy center, or HOPD, models be voluntary, but rather gives covered under the Medicare program, unless otherwise specified at the Secretary broad discretion to design which the Secretary has clear legal § 512.210(b) or (c), that furnishes and test models that meet certain authority to regulate. The proposed rule included RT services in a 5-digit ZIP

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Code linked to a CBSA selected for We have determined that the best freestanding radiation therapy center or participation to an RO beneficiary for an method for obtaining the necessary an HOPD. We proposed at 84 FR 34494 RO episode that begins on or after diverse, representative group of RT that Professional participants would be January 1, 2021, and ends on or before providers and RT suppliers is random required annually to attest to the December 31, 2025, must participate in selection. This is because a randomly accuracy of an individual practitioner the RO Model. selected sample would provide analytic list provided by CMS, of all of the Further, after considering the results that will be more generally eligible clinicians who furnish care concerns raised by the commenters applicable to all Medicare FFS RT under the Professional participant’s regarding the mandatory nature of the providers and RT suppliers and will TIN, as discussed in section III.C.9 of RO Model, we are finalizing required allow for a more robust evaluation of the this final rule. We proposed to define participation for all RT providers and Model. As we explained in the proposed the term ‘‘individual practitioner’’ to RT suppliers located within the CBSAs rule and in this final rule, because mean a Medicare-enrolled physician selected for participation, with the actuarial analysis suggests that the (identified by an NPI) who furnishes RT modification that the Model size will be difference in estimated price updates for services to Medicare FFS beneficiaries, reduced to approximately 30 percent of rates in the OPPS and PFS systems from and have reassigned his/her billing eligible episodes in eligible CBSAs (see 2019 through 2023, in which the OPPS rights to the TIN of an RO participant section III.C.5 of this final rule), and rates are expected to increase (84 FR 34494). We further proposed that with an inclusion of a low volume opt- substantially more than PFS rates, an individual practitioner under the RO out for any PGP, freestanding radiation would result in few to no HOPDs Model would be considered a therapy center, or HOPD that furnishes electing to voluntarily participate in the downstream participant, as discussed in fewer than 20 episodes in one or more Model and that freestanding radiation section II.B. of the proposed rule and of the CBSAs randomly selected for therapy centers with historically lower this final rule. participation in the most recent year RT costs compared to the national We proposed at 84 FR 34494 to define with claims data available (see section average would most likely choose to the term ‘‘Technical participant’’ to III.C.3.c of this final rule). We believe participate, but those with historically mean an RO participant that is a that these modifications address some of higher costs would be less likely to Medicare-enrolled HOPD or the commenters’ concerns regarding the voluntarily participate, we believe that freestanding radiation therapy center, mandatory nature of the RO Model, requiring participation in the RO Model identified by a single CMS Certification Number (CCN) or TIN, which furnishes including those relating to potential will ensure sufficient proportional only the technical component of RT financial hardship as well as the size participation of both HOPDs and services. Finally, we proposed at 84 FR and scope of the Model (see section freestanding radiation therapy centers, 34494 to define ‘‘Dual participant’’ to III.C.3.d of this final rule for more which is necessary to obtain a diverse, mean an RO participant that furnishes information). representative sample of RT providers and RT suppliers that will allow a both the professional component and As stated in the proposed rule and in statistically robust test of the technical component of an episode for this final rule, we believe that by prospective episode payments made RT services through a freestanding requiring the participation of RT under the RO Model. radiation therapy center, identified by a providers and RT suppliers, we would For the previously identified reasons, single TIN. We proposed to codify the have access to more complete evidence we believe that a mandatory model terms ‘‘Professional participant,’’ of the impact of the Model. We also design would be the best way to ‘‘Technical participant,’’ ‘‘Dual believe that a representative sample of improve our ability to detect and participant’’ and ‘‘individual RT providers and RT suppliers would observe the impact of the prospective practitioner’’ at § 512.205. result in a robust data set for evaluation episode payments made under the RO We also explained in the proposed of this prospective payment approach, Model. We therefore are finalizing our rule at 84 FR 34494 that an RO and would stimulate the development of proposal with modification that participant would furnish at least one new evidence-based knowledge. Testing participation in the RO Model will be component of an episode, which would the Model in this manner would also mandatory. have two components: A professional allow us to learn more about patterns of component and a technical component. inefficient utilization of health care b. RO Model Participants We proposed to define the term services and how to incentivize the An RO participant, a term that we ‘‘professional component (PC)’’ to mean improvement of quality for RT services. defined in the proposed rule at the included RT services that may only This learning could potentially inform § 512.205, would be a Medicare-enrolled be furnished by a physician. We future Medicare payment policy. PGP, freestanding radiation therapy proposed to define the term ‘‘technical Therefore, we are finalizing as proposed center, or HOPD that is required to component (TC)’’ to mean the included the selection of a broad, representative participate in the RO Model pursuant to RT services that are not furnished by a sample of RT providers and RT § 512.210 of the proposed rule. As physician, including the provision of suppliers in multiple geographic areas discussed in the proposed rule at 84 FR equipment, supplies, personnel, and (see 84 FR 34495 through 34496, and 34494 through 34495, an RO participant costs related to RT services. (See section section III.C.3.d. of this final rule for a would participate in the Model as a III.C.5.c of the proposed rule at 84 FR discussion regarding the Geographic Professional participant, Technical 34494 through for a discussion Unit of Selection) for RO Model participant, or Dual participant. regarding our proposed included RT participation. However, in response to In the proposed rule, we proposed to services.) We proposed to codify the comments, we are reducing the scale of define the term ‘‘Professional terms ‘‘professional component (PC)’’ the RO Model from the proposed participant’’ as an RO participant that is and ‘‘technical component (TC)’’ at approximately 40 percent of episodes to a Medicare-enrolled physician group § 512.205 of the proposed rule. approximately 30 percent of eligible practice (PGP), identified by a single In the proposed rule, we proposed episodes (please reference section Taxpayer Identification Number (TIN) that an episode of RT under the RO III.C.3.d. of this final rule for more that furnishes only the professional Model would be furnished by either: (1) information). component of RT services at either a Two separate RO participants, that is, a

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Professional participant that furnishes furnishes both the professional can request to opt-in or opt-out of the only the PC of an episode, and a component and technical component of Model. Technical participant that furnishes an RO episode for RT services through Response: We recognize that this only the TC of an episode; or (2) a Dual a freestanding radiation therapy center, scenario could occur where practices participant that furnishes both the PC identified by a single TIN. Professional under the same TIN could fall into and TC of an episode. For example, if participant, Technical participant and different CBSAs whereas some are a PGP furnishes only the PC of an Dual participant are similar to the either in the Model and others are out episode at an HOPD that furnishes the proposed definitions, RT provider and of the Model. As stated in the proposed TC of an episode, then the PGP would RT supplier. In the proposed rule, an RT rule in section III.C.3.d (84 FR 34495 be a Professional participant and the provider is defined as a Medicare- through 34496), we are using CBSAs as HOPD would be a Technical participant. enrolled HOPD that furnished RT the geographic unit of selection for the In other words, the PGP and HOPD service in a 5-digit ZIP Code linked to RO Model for various reasons, including would furnish separate components of a CBSA selected to participate, and an that CBSAs are large enough to reduce the same episode and would be separate RT supplier is defined as a Medicare the number of RO participants in close participants under the Model. –enrolled PGP or freestanding radiation proximity to other RT providers and RT The following is a summary of the therapy center that furnishes RT suppliers that would not be required to public comments received on these services in a 5-digit ZIP Code linked to participate in the Model. As we have proposed definitions related to RO a CBSA selected to participate. These chosen the method of using randomly participants and our responses to those definitions taken together with other selected stratified CBSAs in the RO comments: proposed definitions, RO participant, Model, it is unavoidable that some Comment: A commenter supported Professional participant, Technical practices within the same TIN may fall these key participant distinctions, participant and Dual participant, are into different CBSAs, though we appreciated that CMS recognized that duplicative. For clarification, we are anticipate that the numbers will be RT services can be delivered at different finalizing proposed definitions for the limited. As noted in the commenters’ sites of service, and stated that this Professional, Technical, and Dual letters, situations where a beneficiary participant construct lends itself well to participants in the RO Model without changes treatment locations is rare in the establishment of separate modification, and finalizing the radiation oncology, and we believe that professional and technical payment proposed definitions for RT provider our billing policies would allow components. and RT supplier with modification. RT sufficient flexibility to accommodate Response: We appreciate this provider will mean any Medicare- these uncommon instances, where the commenter’s support on our proposed enrolled HOPD that furnishes RT first treatment provider or supplier definitions for the Professional, services and RT supplier will mean any would be paid through the Model and Technical, and Dual participants in the Medicare-enrolled PGP or freestanding a subsequent provider or supplier RO Model. radiation therapy center that furnishes would bill FFS. We appreciate the Comment: A commenter requested RT services. commenters’ concerns on this matter, clarification on how RO participants As for the specific example the and we will monitor this situation for will be defined if there are multiple commenter presented, the freestanding any issues or complications that may sites of service during an episode. This radiation therapy center would be arise from this policy. commenter provided an example where considered a Dual Participant for After considering public comments, a physician delivers EBRT in a delivery of EBRT, and the HOPD we are finalizing our proposed freestanding setting and then chooses to delivering brachytherapy would bill provisions on the RO Model participant deliver brachytherapy in the hospital traditional Medicare fee-for-service as definitions without change. Specifically, outpatient department (HOPD) setting. described in section III.C.7. In the we will codify at § 512.205 to define an This commenter asked whether the example described, FFS payments made RO participant as a Medicare-enrolled physician in this example would be to the HOPD would be considered physician group practice (PGP), considered a Dual participant such that duplicate payments during freestanding radiation therapy center, or there would be no technical component reconciliation as described in section HOPD that is required to participate in payment issued to the HOPD. This III.C.11. the RO Model pursuant to § 512.210. We commenter suggested that CMS should Comment: Some commenters were are further finalizing our proposal to provide clarification regarding how concerned with the possibility that define the term ‘‘Professional these types of situations will be handled health systems could have some of their participant’’ at § 512.205 as an RO and reimbursed within the Model. practices participating in the RO Model participant that is a Medicare-enrolled Response: As stated in the proposed and their remaining practices operating PGP identified by a single Taxpayer rule at 84 FR 34494, a Professional outside of the Model. These commenters Identification Number (TIN) that participant is an RO participant that is stated that it is common for large health furnishes only the professional a Medicare-enrolled physician group systems to have a single TIN covering component of an RO episode. We are practice (PGP), identified by a single multiple locations, and that the also finalizing our proposal define the Taxpayer Identification Number (TIN) proposed RO Model design could allow term ‘‘Technical participant’’ at that furnishes only the professional practices within the same health system § 512.205 to mean an RO participant component of RT services at either a to fall into different CBSAs. This may that is a Medicare-enrolled HOPD or freestanding radiation therapy center or cause challenges for both RT providers freestanding radiation therapy center, an HOPD. A Technical participant is an and RT suppliers and patients as well as identified by a single CMS Certification RO participant that is a Medicare- cause avoidable complexity in rare Number (CCN) or TIN, which furnishes enrolled HOPD or freestanding radiation situations where patients shift between only the technical component of an therapy center, identified by a single care locations. These commenters, episode. Finally, we are finalizing our CMS Certification Number (CCN) or therefore, recommended that CMS make proposal to define ‘‘Dual participant’’ at TIN, which furnishes only the technical accommodations for health systems § 512.205 to mean an RO participant component of RT services. A Dual with multiple sites, where practices that that furnishes both the professional participant is an RO participant that span multiple CBSA’s with a single TIN component and technical component of

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an RO episode through a freestanding where the RT service is furnished innovation.cms.gov/initiatives/pa-rural- radiation therapy center, identified by a within 28 days of a RT treatment health-model/. single TIN. planning service for an RO beneficiary We designed the proposed RO Model and the RT service is furnished on or to test whether prospective episode c. RO Model Participant Exclusions after the day of this change would be payments in lieu of traditional FFS In the proposed rule at 84 FR 34493 included in the Model. payments for RT services would reduce through 34494, we proposed to exclude We proposed to exclude RT providers Medicare expenditures by providing from RO Model participation any PGP, and RT suppliers in Maryland due to savings for Medicare while preserving freestanding radiation therapy center, or the unique statewide payment model or enhancing quality. In the proposed HOPD that— being tested there (the Maryland Total rule, we discussed our belief that it • Furnishes RT only in Maryland; Cost of Care Model), in which Maryland would be inappropriate to include these • Furnishes RT only in Vermont; hospitals receive a global budget. We entities for the reasons previously • Furnishes RT only in U.S. noted in the proposed rule that this described. Also, we proposed to exclude Territories; ASCs and RT providers and RT • global budget includes payment for RT Is classified as an ambulatory services and as such would overlap with suppliers located in the U.S. Territories, surgery center (ASC), critical access the RO Model payment. Thus, we at § 512.210, due to the low volume of hospital (CAH), or Prospective Payment proposed to exclude Maryland HOPDs RT services that they provide. In System (PPS)-exempt cancer hospital; or addition, we proposed to exclude CAHs • to avoid double payment for the same Participates in or is identified as services. We proposed to extend the and PPS-exempt cancer hospitals due to eligible to participate in the exclusion to all RT providers and RT the differences in how they are paid by Pennsylvania Rural Health Model. suppliers in Maryland to avoid creating Medicare. The proposed rule specified that these a gaming opportunity where certain As a result, we proposed that RT exclusion criteria would apply during beneficiaries could be shifted away from services furnished by these RT the entire Model performance period. If PGPs and freestanding centers to providers and RT suppliers would be excluded from the RO Model. We also an RO participant undergoes changes HOPDs. such that one or more of the exclusion stated that if in the future we determine In the proposed rule, we proposed to criteria becomes applicable to the RO that providers and suppliers in these exclude RT providers and RT suppliers participant during the Model categories should be included in the RO in Vermont due to the Vermont All- performance period, then that RO Model, we would revise our inclusion Payer ACO Model, which is a statewide participant would be excluded from the criteria through rulemaking. model in which all-inclusive RO Model (that is, it would no longer be We proposed to codify these policies population-based payments (AIPBPs) an RO participant subject to inclusion at § 512.210 of our regulations. We are currently made to the participating criteria). For example, if an RO solicited comments on the proposals ACO for Medicare FFS services participant moves its only service related to RO participant exclusions. furnished by all participating HOPDs location 25 from a CBSA randomly The following is a summary of the and an increasing number of selected for participation in Virginia to comments received on these proposals participating PGPs. Given the scope of Maryland, it would be excluded from and our responses to those comments: this model as statewide and inclusive of the RO Model from the date of its Comment: A commenter supported all significant payers, we explained in location change. Conversely, if a PGP, CMS’ decision to exclude from the the proposed rule that we believe freestanding radiation therapy center, or Model providers and suppliers that excluding RT providers and RT HOPD satisfies the exclusion criteria furnish RT services only in Maryland, suppliers in Vermont from the RO when the Model begins, and Vermont, or U.S. Territories; that are Model is appropriate to avoid any subsequently experiences a change such participating in or eligible to participate potential interference with the testing of that the exclusion criteria no longer in the Pennsylvania Rural Health the Vermont All-Payer ACO Model. apply and the PGP, freestanding Model; or that are classified as an We also proposed to exclude HOPDs radiation therapy center, or HOPD is ambulatory surgery center, CAH, or that are participating in or eligible to located in one of the CBSAs selected for PPS-exempt cancer hospital. participate in the Pennsylvania Rural participation, then participation in the Response: We thank this commenter Health Model from the RO Model. RO Model would be required. For for the support on our proposed Hospitals and CAHs that are example, if an HOPD is no longer exclusions from the RO Model; we are participating in the Pennsylvania Rural classified as a PPS-exempt hospital and finalizing these exclusions without Health Model receive a global budget, the HOPD is located in one of the modification. much like hospitals participating in the We would like to clarify that we CBSAs selected for participation, then Maryland Total Cost of Care Model. recognize HOPDs are not standalone the HOPD would become an RO Further, we proposed to extend the institutions and, as such, may not, participant from the date that the HOPD exclusion to HOPDs that are eligible to independent of a hospital or CAH, became no longer classified as a PPS- participate in the Pennsylvania Rural participate in or be eligible for exempt hospital. Health Model because additional participation in the Pennsylvania Rural We proposed that in the case of hospitals and CAHs may join that model Health Model. We will use the list on Professional participants and Dual in the future or may be included in the the Pennsylvania Rural Health Model’s participants, any episodes in which the evaluation comparison group for that website at https://innovation.cms.gov/ initial RT treatment planning service is model. We stated in the proposed rule initiatives/pa-rural-health-model/, furnished to an RO beneficiary on or that we would identify the hospitals and which is updated quarterly, to identify after the day of this change would be CAHs that are participating in or are the hospitals and CAHs eligible to included in the Model. In the case of eligible to participate in the participate in the Pennsylvania Rural Technical participants, any episodes Pennsylvania Rural Health Model on a Health Model, and therefore identify the specific HOPDs that are excluded from 25 Service location means the site of service in list to be updated quarterly and made which an RO Participant or any RT provider or RT available on the Pennsylvania Rural participation in the RO Model. We supplier furnishes RT services. Health Model’s website at https:// would also like to clarify that this

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exclusion of HOPDs associated with status at the PCH, and also provides all physicians practicing in a PCH be hospitals and CAHs eligible to only the professional component of an exempted from the RO Model because participate in the Pennsylvania Rural RO episode for RT services in a these physicians practice in the PCHs as Health Model from the RO Model will freestanding radiation therapy center or well as eligible community practices apply only during the period of such HOPD that is located in a CBSA selected and they all bill under the same TIN, we eligibility. If the Pennsylvania Rural for participation will be considered a would like to clarify that the physicians Health Model is terminated or if the Professional participant under the RO will be exempted from the RO Model if HOPD is no longer eligible to participate Model. Similarly, a physician who they only provide RT services at a PCH. in the Pennsylvania Rural Health Model provides RT services at a PCH, and also However, if the physician also provides as part of an eligible hospital or CAH, furnishes both the professional RT services at any other freestanding and the HOPD otherwise meets the component and technical component of radiation therapy center and/or HOPD definition of an RO participant, then the an RO episode for RT services through that is included in a CBSA selected for HOPD will be required to participate in a freestanding radiation therapy center, participation, they will be considered a the RO Model. identified by a single TIN, will be Dual participant and/or Professional Comment: A commenter supported considered a Dual participant under the participant under the RO Model. We CMS’ decision to exclude CAHs from RO Model. In contrast, a physician who disagree with commenters’ requests to the RO Model, and stated that they provides RT services only at an exempt expand the PCH exclusion list to appreciated CMS’ recognition of the facility (PCH, CAH, or ASC) will not be include all National Cancer Institute potential negative impact the Model an RO participant. RT services that are (NCI) Designated Comprehensive Cancer could have on CAHs. This commenter furnished at an exempt facility (PCH, Centers as PCHs are reimbursed on a also requested that CMS clarify whether CAH, or ASC) will be paid through FFS, ‘‘reasonable cost’’ basis instead of the a clinician who provides cancer while RO episodes that are furnished at OPPS FFS methodology, and we are treatment services at a CAH would be a PGP, freestanding radiation therapy excluding entities that are paid via considered a Professional participant center, or HOPD that is in a CBSA reasonable cost or cost-reporting, and under the RO Model. This commenter selected for participation will be paid including all HOPDs that are currently also suggested that CMS ensure that the under the RO Model payment paid through the OPPS/FFS technical and professional services are methodology. methodology. Thus, we will be aligned, and further recommended that Comment: A few commenters agreed finalizing our policy as proposed and if a treatment center is excluded from with CMS’ proposal to exclude from the without modification to exclude from the Model, then the clinicians providing Model PCHs, which some commenters the RO Model any PGP, freestanding services at that treatment center should also referred to as DRG-exempt cancer radiation therapy center, or HOPD that also be excluded. hospitals. A commenter agreed that is classified as a PCH. However, the RO A few commenters requested PCHs should be excluded from the Model will include PGPs, freestanding clarification on CMS’ proposed policy Model, and further requested that all of radiation therapy centers and HOPDs regarding an exclusion for PPS-exempt the physicians practicing in these PCHs that are paid under FFS. cancer hospitals (PCHs) in the Model. A be exempted from the RO Model commenter requested clarification on because these physicians practice in the Comment: Conversely, some whether radiation oncology physicians PCHs as well as eligible community commenters disagreed with the proposal who work for a PCH but bill under a practices and they all bill under the to exclude PCHs from the Model. Of practice TIN, would be considered a same TIN. The commenter indicated those who disagreed, a couple of Professional or Dual participant. that this would complicate data commenters stated that PCHs should be Another commenter requested submission and analysis as well as incentivized to reduce costs, and clarification on how the professional billing practices. A couple of pointed to a Government Accountability reimbursement will be handled for commenters suggested that CMS expand Office (GAO) report that advised that physicians practicing in a PCH, but not the exclusion list to include all National the payment method for PCHs should be employed by that legal entity. The Cancer Institute (NCI) Designated revised to promote efficiency and commenter asked for clarification on Comprehensive Cancer Centers. One of reduce costs to Medicare. Another whether the physicians would also be these commenters stated that this policy commenter inquired why PCHs are exempt. This commenter further stated would align with CMS’ proposal to exempted when they are among the best that the same physicians may also exempt PCHs. Another commenter resourced institutions and are practice at other non-PCH, and it is not stated that NCI-designated centers considered high cost centers due to uncommon for radiation oncologists to deliver innovative cancer treatments to emerging technologies. Another rotate through multiple facilities in a patients in communities across the commenter sought clarification on why given week, depending on the size of United States, and dedicate significant CMS decided to exclude a set of RT the physician practice and the number resources toward developing providers and RT suppliers that of facilities where they practice. multidisciplinary programs and specifically treat the targeted conditions Response: To clarify, a physician who facilities that lead to better and in the RO Model, and stated that the provides cancer treatment services at a innovative approaches to cancer largest cancer treatment centers should CAH, PCH, or ASC, and also provides prevention, diagnosis, and treatment. not be excluded from a model that seeks services in a freestanding radiation This commenter stated that introducing to address utilization for cancer therapy center or HOPD that is located an APM based on complex calculations services. Another commenter stated that in a CBSA selected for participation, in and historical rates would represent a it is difficult to understand why PCHs addition to their services at a CAH, significant burden that would negatively would be excluded from the RO Model PCH, or ASC, will be considered either impact the innovation and discovery on the basis of payment methodology a Dual participant or Professional missions of NCI-designated centers. when payment methodology is the participant, respectively, under the RO Response: We appreciate these primary basis of the Model. Another Model. We also want to clarify that a commenters’ support of our proposal to commenter stated the 11 PCH have large physician who provides RT services at exclude PCHs from the RO Model. With amounts of grant money, have many a PCH, regardless of their employment regard to the comment requesting that staff, and receive significant Medicare

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payments, and accordingly should be significantly impact the financial due to lower payment through the RO included in the Model. A commenter viability of these hospitals or lead to a Model. Additionally, some of these stated that the 11 PCHs should not be reduction in available services for the commenters suggested that that the RO excluded from Model because these community. Model should be limited to large groups hospitals have developed financial Response: We did not propose to (30 physicians or more), and that the relationships with many community exclude MDH or SCH entities from the Model should be limited to large hospitals that give those hospitals both RO Model because, unlike CAHs, these hospitals with employed physicians. a financial and a marketing advantage. entities are full service hospitals. If A couple of commenters stated that a This commenter stated that if a CBSA is MDH and SCH entities believe they low-volume exemption is critical in a selected for participation and has one of qualify for the RO Model’s low volume shared risk-based model of care, and these exempt hospitals, that facility will opt-out option, please reference the should therefore be included in the RO have a significant advantage over the discussion on the low volume opt-out Model. Another commenter supported other sites of service in that area, and option in this section of the final rule CMS’ proposal to exclude ASCs and RT this would allow that facility to more for more information. We will monitor providers and suppliers located in the heavily market and to purchase the extent to which these hospitals are U.S. Territories due to the low volume upgraded equipment, which would selected for participation in the Model, of RT services that they provide because threaten the viability of other programs and we will monitor the impact the RO of the commenter’s belief that such and decrease access and choice for Model may have on these types of providers and suppliers lack the Medicare beneficiaries needing RT entities. infrastructure and support to achieve services. Comment: A commenter requested an efficiencies. However, the commenter Response: The RO Model is designed exemption to the RO Model for practices requested that CMS fully exclude from to test whether prospective episode that serve socioeconomically the Model providers and suppliers who disadvantaged populations. This payments in lieu of traditional FFS furnished fewer than 60 attributed commenter stated that these practices payments for RT services would reduce episodes during the 2015–2017 period, tend to have higher costs of care because Medicare expenditures by providing rather than just making adjustments to patients present with advanced stages of savings for Medicare while preserving their episode payments. This disease often due to the lack of access or enhancing quality of care. We commenter further stated that its to preventative services, and these proposed to exclude PCHs because of analysis found that there is considerable practices should not be penalized due to the differences in how these hospitals variation in episode spending relative to are paid by Medicare. That is, they are circumstances that are out of their payment amounts for providers and not paid through traditional FFS control. suppliers that perform a very low payments (see, generally, the Social Response: We did not propose to volume of RT, and the commenter Security Amendments of 1983 (Pub. L. exclude practices that serve maintained that this analysis suggests 98–21), the Balanced Budget Act of 1997 socioeconomically disadvantaged that episode pricing for these providers (Pub. L. 105–33), and the Omnibus populations, and we will not be creating and suppliers would be highly random Reconciliation Act of 1989 (Pub. L. 101– an exemption of this nature at this time. and, therefore, very difficult to manage. 239)), and the RO Model is designed to While we understand the commenter’s The commenter finally concluded that test and evaluate the change from concern, we believe that the RO Model excluding these and other low-volume traditional FFS payments to prospective pricing methodology, through the episode based payments. Regarding the historical experience and case mix providers and suppliers would have a commenter’s concern about PCHs and adjustments, will account for minimal impact on the RO Model test, their community hospital partners differences in RO participants’ historical but doing so would prevent these potentially having a financial and care patterns and the demographic providers and suppliers from being marketing advantage, we will monitor characteristics of their patient inappropriately penalized by being the Model for the occurrence of any populations. We will monitor the effect required to participate in the Model. such advantages, by monitoring for that the RO Model may have on RO Response: We appreciate the changes in referral patterns. Based on participants that serve these commenters’ comments and feedback this monitoring, if we determine to populations. regarding low-volume entities under the modify the excluded categories of RT Comment: Many commenters stated RO Model. We understand the providers and RT suppliers, including that a mandatory RO Model will present commenters’ concerns regarding PCHs, we would revise the RO Model operational, administrative, and administrative, financial, and inclusion criteria through future notice- financial challenges for many RT infrastructural challenges for low- and-comment rulemaking. Therefore, providers and RT suppliers, and volume providers and suppliers under we are finalizing our policy as proposed therefore requested a low-volume or the RO Model. In response to without modification to exclude from hardship exemption to allow stakeholder comments, we are finalizing RO Model participation any PGP, participants to opt out of the RO Model. our mandatory participation proposal, freestanding radiation therapy center or Many commenters disagreed with CMS’ with a modification for an opt-out HOPD that is classified as a PPS-exempt decision to not include a model option for low-volume entities, which cancer hospital. participation hardship exemption for we are codifying at § 512.210(c). This Comment: A commenter suggested any providers or suppliers, and option allows any PGP, freestanding that CMS should exclude sole requested an exemption from Model radiation therapy center, or HOPD to community hospitals (SCH) and participation specifically for low- opt-out of the RO Model, if in the most Medicare dependent hospitals (MDH). volume providers and suppliers. These recent calendar year with episode data These hospitals are generally rural, commenters argued that failure to available, the entity furnishes fewer small, and highly dependent on include a low-volume exemption could than 20 episodes in one or more of the Medicare and/or Medicaid funding. result in unintended consequences, CBSAs randomly selected for This commenter does not believe it such as smaller providers and suppliers participation. Please reference the end would be appropriate to include these incurring significant financial losses of this section for more information on hospitals in the RO Model as it could and potentially ending their programs the low volume opt-out option.

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Regarding the commenters suggested or furnishes 200 or fewer covered out of the RO Model on an annual basis that that the RO Model should be professional services to Medicare Part if the PGP, freestanding radiation limited to large groups (30 physicians or B–enrolled individuals. RT providers therapy center, or HOPD furnishes fewer more), we would like to note that most and RT suppliers tend to see smaller than 20 episodes across all CBSAs RT providers and suppliers have fewer numbers of patients but at a higher price selected for participation in the most than 30 oncologists, so this number per patient than the average MIPS recent calendar year with available would not provide a feasible threshold eligible clinician. Therefore, we claims data. We are codifying this for the RO Model. estimate that using the MIPS low- modified policy at § 512.210(c) of the We agree in part with the commenter volume threshold as a threshold for final rule. who suggested that we add an exclusion mandatory participation in the RO Each RO participant’s episode volume of entities with fewer than 60 episodes Model would result in a nearly 50 will be assessed at the TIN and CCN over the full baseline period of three percent reduction in the number of RO level across all CBSAs randomly years. We are focusing on entities with participants. As stated in section selected for participation, not according fewer than 20 episodes in the most III.C.3.d of this final rule, the number of to how many episodes an RO recent year with available claims data, RO participants must remain above a participant furnishes in a single CBSA. and we believe this corresponds with certain level in order to maintain For example, if an RO participant this commenter’s suggestion. However, statistical power for Model evaluation, furnished 30 episodes in two different instead of excluding such entities, we and to generate sufficient savings. We CBSAs and both CBSAs are selected for believe that allowing entities with fewer are finalizing our mandatory participation in the Model, then the RO than 20 episodes to opt-out achieves the participation proposal, with a participant would not be eligible for the right balance of allowing very small modification for an opt-out option for low volume opt-out option, even if the entities to opt-out if they believe the low-volume entities as described in this RO participant furnished fewer than 20 burden from participation in the Model final rule. Similar to the CJR Model’s episodes in each of those CBSAs. If, would outweigh the possibility of policy, this option would allow any however, an RO participant only benefits from model participation (for PGP, freestanding radiation therapy furnished 15 episodes in only one CBSA example, potential for care center, or HOPD that furnishes fewer selected to participate in the Model, improvements or increased payments), than 20 episodes in the most recent year then this RO participant would be while also maintaining a variety of with available claims data within one or eligible for the low volume opt-out participant types in the RO Model to more of the CBSAs randomly selected option. promote generalizability (to the extent for participation to opt-out of the RO RO participants that qualify for the possible) of any impact results. Further, Model, if they so choose. For more low volume opt-out may still choose to as discussed in section III.C.6.e(4), we information on this final policy please participate in the Model, as our data do not apply adjustments to RO see this section of this rule. There are show that many of these RT providers participant episode payments for notable differences between the CJR and and RT suppliers may see increased participants that have less than 60 RO Models’ low volume opt-out payments (compared to historical episodes in the last three years of data. options. The CJR Model’s low-volume payments) and improvements in quality Thus, the opt-out option for entities policy was a one-time opt-in option for of care under the RO Model despite with fewer than 20 episodes aligns with participants, while the RO Model will having a low volume of episodes. Thus, the threshold set for the historical make the low volume opt-out option we believe it is important to allow them experience and case mix adjustments. available to eligible participants the option of participating in the RO The low volume opt-out option is annually, prior to each year of the Model if they so choose. intended to allow RO participants Model. Prior to the start of each RO Model furnishing a small volume of RT After considering public comments, PY, we will identify which RO services in the CBSAs selected for we are finalizing, with one participants would be eligible to opt out participation in the Model to opt out if modification, our proposed provisions of the Model (including the RO Model they so choose given the investment on RO Model participant exclusions. As payments and participation required to implement the Model versus proposed, we are finalizing our policy, requirements) based on the most the benefit of participating in the Model and codifying at § 512.210(b), to exclude recently available claims data. For PY1 for a limited frequency of RT services. from RO Model participation any PGP, (January 1, 2021, through December 31, Comment: Some commenters freestanding radiation therapy center, or 2021), we will use 2019 episode data, suggested that CMS apply the MIPS HOPD that furnishes RT services only in for PY2 (January 1, 2022 through low-volume threshold or the CJR Model Maryland; furnishes RT services only in December 31, 2022), we will use 2020 low-volume exemption as low-volume Vermont; furnishes RT services only in episode data, and so on. The most participation thresholds for mandatory U.S. Territories; is classified as an current episode data is two years RO Model participation. ambulatory surgery center (ASC), removed from the period to which it Response: For the 2020 MIPS critical access hospital (CAH), or applies for two reasons. First, as performance period, the MIPS low- Prospective Payment System (PPS)- described in the pricing methodology volume threshold excludes from the exempt cancer hospital; or participates section in section C.III.6, if an RO definition of a MIPS eligible clinician an in or is identified by CMS as eligible to episode straddles calendar years, the RO individual eligible clinician, group, or participate in the Pennsylvania Rural episode and its claims are counted in APM Entity group that, during the MIPS Health Model. the calendar year for which the initial determination period (consisting of two In response to public comments, we treatment planning service is furnished. 12-month segments during 10/1/18–9/ are finalizing with one modification our This means that an RO episode could 30/19 and 10/1/19–9/30/20), has proposal regarding mandatory carry 89 days into the next performance allowed charges for covered participation in the Model. A PGP, year. Second, we will allow for at least professional services less than or equal freestanding radiation therapy center, or one month of claims run-out after all RO to $90,000, furnishes covered HOPD which would otherwise be episodes have been completed. A longer professional services to 200 or fewer required to participate in the RO Model claims run-out is not necessary since the Medicare Part B–enrolled individuals, under § 512.210(a) may choose to opt- low volume opt-out is based on a count

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of complete episodes and not on volume location where RT services are participation and CBSAs selected for of services during those RO episodes. furnished. This will permit us to comparison under the Model. For these reasons, the most current identify RO participants (see section As explained in the proposed rule, episode data is two years removed from III.C.3.c of the proposed rule and this not all five-digit ZIP Codes fall entirely the period to which it applies. final rule for a discussion of RO Model within OMB delineated CBSA Broadening the assessment period to participant exclusions for the RT boundaries, resulting in some five-digit multiple years would even further providers and RT suppliers we ZIP Codes assigned to two different remove the opt-out option from current proposed to exclude from this Model) CBSAs. Approximately 15 percent practice patterns. while still using CBSA as a geographic (15%) of five-digit ZIP Codes have We will use only the most recent year unit of selection. We proposed to codify portions of their addresses located in with available claims data rather than a the term ‘‘Core-Based Statistical Area more than one CBSA. If each ZIP Code 3-year baseline to identify low-volume (CBSA)’’ at § 512.205 of our regulations. was assigned only to the CBSA with the RO participants. This policy would The proposed rule explained that largest portion of delivery locations in allow us to better recognize low-volume CBSAs are delineated by the Office of it, about 5 percent of all delivery RO participants over time and avoid Management and Budget and published locations in ZIP Codes would be creating a permanent opt out for new on Census.gov.26 A CBSA is a statistical assigned to a different CBSA. Rather entities. At the same time, we want to geographic area with a population of at than increase health care provider minimize the possibility that RT least 10,000, which consists of a county burden by requiring submission of more providers and RT suppliers would have or counties anchored by at least one detailed geographic data by RT an incentive to create a new billing core (urbanized area or urban cluster), providers and RT suppliers, we identifier each year to get out of the plus adjacent counties having a high proposed to assign the entire five-digit Model. Thus, we would monitor for this degree of social and economic ZIP Code to the CBSA where the ZIP scenario by examining whether new integration with the core (as measured code has the greatest portion of total addresses (business, residence, and TINs/CCNs in the Model geographic through commuting ties with the area have the same address as a other addresses) such that each five- counties containing the core). CBSAs previous TIN/CCN to ensure that our digit ZIP Code is clearly linked to a are ideal for use in statistical analyses policy is serving its intent. unique CBSA or non-CBSA geography. because they are sufficiently numerous Eligibility for the opt-out option will In the event that the portion of total to allow for a robust evaluation and are be assessed annually. A participant may addresses within the five-digit ZIP Code also large enough to reduce the number qualify for the opt-out option in one is equal across CBSAs and cannot be of RO participants in close proximity to performance year, but not in another. At used to make the link, we proposed that other RT providers and RT suppliers least 30 days prior to the start of each the greater portion of business addresses that would not be required to participate PY, we will notify participants eligible would take precedence to link the five- for the opt-out option as it concerns that in the Model. CBSAs do not include the digit ZIP Code to the CBSA. upcoming PY. Those RO participants extreme rural regions, but there are very We proposed to use a five-digit ZIP eligible to opt-out of the RO Model must few RT providers and RT suppliers in Code to CBSA crosswalk found in the attest to the intention of opting out of these areas such that, if included, the Housing and Urban Development (HUD) the Model prior to the start of the areas would likely not generate enough ZIP to CBSA Crosswalk file 27 to link applicable PY (that is, on or before episodes to be included in the statistical each five-digit ZIP Code to a single December 31 of the prior PY in which analysis; further, CBSAs do contain CBSA. The HUD ZIP to CBSA Crosswalk the opt-out would occur). We will rural RT providers and RT suppliers as file lists the ZIP Codes (which come provide further instructions on designated by CMS and Health from the United States Postal Service) submitting this attestation through Resources and Services Administration that correspond with the CBSAs (which subregulatory channels of (HRSA). Therefore, CBSAs would are Census Bureau geographies) in communication, such as model-specific capture the diversity of RT providers which those ZIP Codes exist, allowing webinars, and the RO Model website. and RT suppliers who may be affected these two methods of geographic This process would be repeated prior to by the RO Model, and, consequently, we identification to be linked. each performance year of the Model. did not propose to include non-CBSA We indicated in the proposed rule This could result in some RO geographies in the RO Model test. that we believed that linking a five-digit participants being eligible for the opt- However, as noted in the proposed ZIP Code to a single CBSA would not out option in some years and not others, rule, most RT providers and RT substantially impact statistical estimates that is, an RO participant could be able suppliers may not know in what CBSA for the RO Model. In addition, we to opt out in one year and then be they furnish RT services. In order to believed that using a service location’s required to participate in the subsequent simplify the notification process to five-digit ZIP Code to determine year. We will notify participants to inform RT providers and RT suppliers whether an RT provider or RT supplier remind them to verify their eligibility whether or not they furnish RT services must participate in the Model will avoid for the opt-out option prior to each in a CBSA selected for participation, we potential RT provider or RT supplier performance year. proposed to use an RT provider’s or RT burden by avoiding an additional supplier’s service location five-digit ZIP requirement that they submit claims d. Geographic Unit of Selection Code found on the RT provider’s or RT using more detailed geographic We proposed at 84 FR 34495 through supplier’s claim submissions to CMS to information. We proposed to provide a 34496 that the geographic unit of link them to CBSAs selected for look-up tool that includes all five-digit selection for the RO Model would be ZIP Codes linked to CBSAs selected for OMB’s Core-Based Statistical Areas 26 See OMB Bulletin No. 18–04 entitled ‘‘Revised participation in accordance with our (CBSAs). Due to geographic data Delineations of Metropolitan Statistical Areas, limitations on Medicare claim Micropolitan Statistical Areas, and Combined 27 Datasets and documentation for HUD USPS Zip submissions, we proposed to link RT Statistical Areas, and Guidance on Uses of the Code Crosswalk Files (which includes the Delineations of These Areas,’’ https:// previously mentioned HUD ZIP–CBSA crosswalk providers and RT suppliers to a CBSA www.census.gov/programs-surveys/metro-micro/ file) can be found here: https://www.huduser.gov/ by using the five-digit ZIP Code of the about/omb-bulletins.html. portal/datasets/usps_crosswalk.html.

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selection policy described in this final show the impact of the Model. The selected for comparison each contain rule. This tool will be located on the RO comparison group would consist of RT approximately 40 percent of all eligible Model website, as proposed. providers and RT suppliers from episodes nationally. We proposed that In the proposed rule, we discussed randomized CBSAs within the same the CBSAs selected for comparison how using CBSAs to identify RO strata as the selected RO participants would be used to evaluate the impact of participants would enable CMS to from the participant group, resulting in the RO Model on spending, quality, and analyze groups of RT providers and RT a comparison group of an approximately utilization. Further, we proposed that suppliers in areas selected to participate equal number of CBSAs and episodes as CBSAs would be randomly selected and in the Model and compare them to in the participant group that would the ZIP Codes linked to those CBSAs groups of RT providers and RT allow for the effects of the RO Model to selected for participation would be suppliers not participating in the Model be evaluated. We proposed that strata published on the RO Model website (84 FR 34496). To the extent that CBSAs would be divided into five quintiles once the final rule is displayed. act like or represent markets, these based on the total number of episodes The following is a summary of group analyses would allow CMS to within a given CBSA. The stratification comments we received related to the observe potential group level, market- would improve the balance between the proposed geographic unit of selection like effects. We have found group level CBSAs selected for participation and the and our responses to those comments: effects important as context for CBSAs selected for comparison by Comment: A couple of commenters understanding the results of other limiting uneven numbers of RT provider believed that approximately 40 percent models tested under section 1115A of and RT supplier and episodes within of episodes constituted more than a test the Act. For example, stakeholders the CBSAs selected for participation and and a few requested a reduction in the questioned whether a model changed of CBSAs selected for comparison that scale of the proposed Model. CMS the overall volume of services related to could result from a simple random received many comments related to the the specific model in a given area. As sample. We proposed that if a CBSA proposed size of the RO Model, where noted in the proposed rule, we will not were randomly selected to the CMS proposed to include approximately be able to address this issue for the RO participant group, then the RT providers 40 percent of episodes in the Model. All Model without using a geographic area and RT suppliers who furnish RT of the commenters who submitted as the unit of analysis. services in that CBSA selected for feedback on this issue were opposed to With respect to selecting CBSAs for participation would be RO participants. the size of the Model, and many participation and comparators under the If the CBSA were randomly assigned to commenters suggested that the size of Model, we proposed to use a stratified the comparison group, then the the Model should be decreased from sample design based on the observed providers and suppliers who furnish RT approximately 40 percent of all eligible ranges of episode counts in CBSAs services in that CBSA selected for episodes annually. These commenters using claims data from calendar years comparison would not be RO suggested many alternatives to CMS’ 2015–2017. We proposed to then participants, but the claims they proposal to include approximately 40 randomize the CBSAs within each generate and the episodes constructed percent of all eligible episodes, most of stratum into participant and comparison from those claims would be used as part which suggested a range of 7 percent to groups until the targeted number of RO of the RO Model’s evaluation. 25 percent of episodes to be included in episodes within each group of CBSAs As discussed in the proposed rule, the Model; some suggested a gradual needed for a robust 28 test of the Model after determining the sampling phase in of additional RO participants is reached. We noted that the primary framework, we conducted the necessary over the course of the Model. purpose of the evaluation is to estimate power calculations (statistical tests to Response: Incorporating some public the impact of the Model across all determine the minimum sample size of commenters’ request for a reduced size participating organizations. Larger the participant and comparison groups of the Model while ensuring sufficient sample sizes decrease the chances that in the Model, designed in order to sample for a robust evaluation, we have the evaluation will produce mistakes, produce robust and reliable results) determined that a reduced scale from that is, show ‘no effect’ when an effect using Medicare FFS claims from January approximately 40 percent of eligible is actually present (for example, when a 1, 2015 through December 31, 2017, to episodes to approximately 30 percent of smoke detector fails to sound an alarm construct episodes and then identify a eligible episodes, is sufficient to even though smoke is actually present) sufficient sample size so that results produce robust evaluation results for the or show ‘an effect’ when no effect is would be precise and reliable. We stated finalized Model. By requiring actually present (for example, when a in the proposed rule that we determined approximately 30 percent of eligible smoke detector is sounding an alarm that approximately 40 percent of eligible episodes to be included in the Model, that suggests smoke is detected when episodes (as discussed in section III.C.5 we expect to be able to detect a savings actually no smoke is present). Given of the proposed rule and this final rule) of 3.75 percent or greater at a that we proposed to sample in eligible CBSAs nationally would significance level of 0.05 and with a approximately 40 percent of all eligible allow for a rigorous test of the RO Model power of 0.8. RO episodes in eligible CBSAs that would produce evaluation results Based on the comments received, we nationwide (as discussed in section that we can be confident are accurately are finalizing the proposed scope of the III.C.5 of the proposed rule and this reflecting what actually occurred in the Model at § 512.210(d) with modification final rule), we believe we should be Model test. We also stated that this size to reflect a reduced scale to sufficiently powered (that is, the sample would limit the number of episodes approximately 30 percent of the eligible size and the expected size of the effect expected in the participant group to no episodes. We note that this decision is of the Model are both large enough at a more than is needed for a robust supported by additional power given significance level) to confidently statistical test of the projected impacts calculations incorporating updated of the Model. episode data from 2016–2018 FFS 28 ‘Robust’ in statistical terminology means that The proposed rule explained that claims data that was not available for we can have high confidence in the test results using randomly selected stratified reliable analysis at the time of the under a broad range of conditions, for example, lower quality data, a shortened test period, or other CBSAs would ensure that the CBSAs proposed rule but became available unexpected complications. selected for participation and CBSAs during the fall of 2019 in order to

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confirm the appropriateness of the and suppliers under the RO Model will payments be applied to all RT providers minimal sample size that would appropriately cover the costs of and RT suppliers and not restrict this incorporate the finalized design of the standard operations and profits for RT payment change to the proposed RO Model. providers and suppliers. We appreciate approximately 40 percent of CBSAs Comment: Many commenters were the possibility of instances where RT selected for participation. opposed to mandatory participation of providers and suppliers are cross- Response: In designing the Model, a RT providers and RT suppliers located subsidizing finances from high-earning driving principle for us was patients in a random sample of core-based locations to lower-earning locations, but being able to continue to access high- statistical areas (CBSAs). A commenter this is not directly under CMS control— quality care. As we stated in the was concerned that random selection of these are external financing practices proposed rule and in this final rule, participants did not account for which CMS does not have authority there are tradeoffs to consider in the vulnerable beneficiary populations or over. HHS has additional programs design of a Model with respect to the vulnerable providers and suppliers. which provide help with financing for unit of selection. The mixture of Another commenter expressed concern potentially vulnerable populations and concern and support for the proposed on the potential of certain RT provider providers and suppliers (such as HRSA design as expressed through the and RT supplier sites being selected in programs for the vulnerable and comments described here is further the Model and the potential payment underserved). Additionally, for certain evidence of those tradeoffs. reductions they may face due to the low volume RT providers and RT We do not have data that definitively Model, which would prevent them from suppliers, we are providing a low delineates markets for RT services. subsidizing more rural locations which volume opt-out option, as discussed in However, we believe by adopting currently do not cover the costs of care. section III.C.3.c of this final rule. CBSAs as proxies for those markets that Response: As we explained in the Comment: Some commenters we will achieve a reasonable balance proposed rule and this final rule, due to expressed concern that the use of Core- among the tradeoffs raised by concerns about a voluntary model being Based Statistical Areas (CBSAs) to commenters and discussed in the subject to: (1) Selection bias from identify RO participants could result in proposed rule. To the extent that CBSAs limited to no participation from HOPDs; unintended consequences, such as act like or represent markets, these (2) an even larger geographic scope picking ‘winners and losers’ in markets. group analyses would allow CMS to requirement for a model with optional These comments largely focused on observe potential group level, market- participation to account for the ‘patient overlap’ and the potential like effects. We have found group level projected bias and lower participation incentive for patients to travel, effects important as context for rates; (3) the ability of such a model depending on the patient’s preference, understanding the results of other with optional participation to achieve in order to see a RT provider or RT models tested under section 1115A of savings; and (4) a reduced likelihood of supplier who either is an RO participant the Act. Please see section III.C.3.d for reliably detecting change to support or a RT provider or RT supplier not a discussion of CBSAs as markets due Model expansion, we proposed to selected to participate in the Model. to their high degree of social and require participation of RT providers Comments appeared to suggest that all economic integration. Because CBSAs and RT suppliers located in a random RT providers and RT suppliers in a can yield market-like effects, CMS sample of core-based statistical areas particular market be selected to be RO believes that CBSAs are the best (CBSAs). Mandatory participation participants or not. A commenter stated available option for selection of RT among randomly selected providers and that patients could be negatively participation. suppliers ensures that the evaluation impacted by the Model as beneficiaries We shared the concerns with results about the RO Model will be seeking RT services in included ZIP commenters that selection of some robust (both reliable, in that the effects Codes must also participate in the CBSAs may create specific situations, in savings we would see are not due to Model or travel to a geographic area not such as a health system having practices chance and not biased due to selection included in the Model for care in multiple locations and/or those of participants that are not (regardless of their ability to do so). A located near the border of a CBSA. We representative of all RT providers and commenter was worried about the understand the concern that the Model RT suppliers), so that these results can potential differences between CBSAs could potentially result in health provide for the Chief Actuary of CMS to selected for participation and CBSAs systems having both RO participants certify that expansion of the Model selected for comparison with respect to and non-participants, as this could would reduce (or would not result in treating prostate cancer if there was an produce additional burden for these any increase in) net program spending uneven incidence of prostate cancer systems in terms of billing and the in the future if the Department chooses cases between RO participants and ability to manage patients. This issue is to pursue expansion under 1115A(c) of comparators—the comment cited the one such tradeoff in the design of the the Act. Therefore, we will not be ‘greater levels of technology’, such as Model. We determined that some modifying our proposal to randomly IMRT (intensity-modulated radiation systems would have locations providing select CBSAs to identify RT providers therapy) that is often used to treat RT services that experience the Model and RT suppliers that are required to prostate cancer. The commenter was conditions as an RO participant and participate in the Model through a similarly concerned with the potential other locations providing RT services stratified sample design. for lower-risk patients to be used as a that are not RO participants. We chose The well-being of potentially benchmark in comparison CBSAs while CBSAs to attempt to minimize the vulnerable patients is always of primary higher-risk patients would be in the number of such occurrences. We would concern to CMS. As such, we will CBSAs selected for participation, also like to note that episodes are examine and monitor vulnerable particularly with regards to race. assigned to a single CBSA by way of the populations and providers and One commenter fully agreed with ZIP Code of the RT supplier that suppliers for any unintended proposed geography-based furnished the planning service that consequences of the random selection of randomization process, stating that the triggered the RO episode. RO participants in the Model. CMS proposed process was fair and unbiased. We believe that using stratified expects that the payments to providers A commenter suggested that site-neutral randomization will minimize potential

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selection problems and unintended on the particular CBSAs selected for Response: We appreciate the consequences, including other potential participation in the RO Model. commenter’s suggestion. A look-up tool imbalances in cancer type (and Response: We appreciate the that includes all of the five-digit ZIP corresponding modality) or patient risk. commenters’ concerns regarding an Codes linked to CBSAs selected for We can identify and account for opportunity to comment on particular participation in accordance with our observed imbalances that may result CBSAs selected for participation, but finalized selection policy described in from randomized selection in the these comments fall outside the scope of this final rule is located on the RO evaluation. The Model (and its our proposed policy. We would like to Model website (https:// exclusions) were designed to minimize clarify that we will use the most innovation.cms.gov/initiatives/ the potential consequences. We are recently available HUD USPS ZIP Code radiation-oncology-model/). This tool finalizing the adoption of CBSAs as the Crosswalk Files (https:// will allow included entities that furnish geographic unit of selection in the RO www.huduser.gov/portal/datasets/usps_ RT services to identify if they are Model. crosswalk.html#data) to link a new five- included or excluded from the RO We seek to support Medicare patients’ digit ZIP Code to a CBSA in the manner Model based on their site of service. We rights to seek care wherever they as described in section III.C.3.d. will refrain from including personal choose. We do not believe that the Currently, the HUD USPS ZIP Code identification information of specific changes in health care provider Crosswalk Files are updated quarterly. If physicians in the release of the RT payments in the RO model would justify the most recently available HUD USPS providers and suppliers selected to or lead to beneficiaries travelling to ZIP Code Crosswalk File links any participate. We believe that relevant entirely different CBSAs to seek RO additional five-digit ZIP Codes to the entities within selected participating care, which involves frequent CBSAs selected for participation, we ZIP Codes will already be aware if they treatments over a short period. We will add those ZIP Codes to the ZIP meet the exclusion criteria for the designed the model with CBSAs to Codes included under the Model. The Model (for example, if they whether prevent RO participants from shifting look-up tool that includes all of the five- they are PPS-exempt cancer hospitals, patients who require more expensive digit ZIP Codes linked to CBSAs critical access hospitals (CAHs), or are care to a site of service which would not selected for participation will be located within certain exclude states be included in the RO Model. The updated with the additional ZIP Codes. (Maryland, Vermont, U.S. Territories) or CBSAs selected for participation will be Once a five-digit ZIP Code is assigned are participating in or eligible to in distinctive locations, and we believe to a CBSA selected for participation participate in the Pennsylvania Rural the potential effects on patient costs under the Model, it will not be removed Health Model as codified at § 512.210. would not substantial. Based on these from the list of included ZIP Codes. However, any entity who may want to facts and the frequency needed for Comment: A couple of commenters confirm their exclusion will be free to radiation therapy treatments, we do not were concerned that the Model design contact the RO Model help desk believe that the RO Model would create had the potential not to include a ([email protected]). an incentive for beneficiaries to avoid sufficient number of proton beam Comment: A commenter has RO participants. In other words, we do therapy (PBT) centers to be able requested that we select patients not believe that the RO Model would adequately detect the impact of the randomly to be included in the Model. create a situation where beneficiaries Model on proton centers in isolation. Response: The Model design is such systematically choose to receive RT Response: The evaluation of the RO that RO participants will be selected services from an RT provider or supplier Model will be primarily interested in through randomized CBSAs: Those that they would not otherwise seek care the impacts of the Model on the overall CBSAs selected for participation and from in absence of the model. We spending and quality of care across all CBSAs selected for comparison. The believe the compensation we are included RT services at the population Model is not designed to randomly providing under this Model is fair and level, and not the effects on one RT select patients from within selected RO this should not affect where modality compared to another. While participants. CMS chose not to design beneficiaries seek RT services. some future evaluation analyses may the RO Model to randomly select The RO Model’s inclusion of include differences in costs and quality patients as this would have created a approximately 30 percent (or a greater by modality, we will make no impact much greater burden, administratively percent) of all RT providers and estimates on cost nor quality where we and operationally, for RT providers and suppliers for a finite period of time does do not have suitable sample size of suppliers who see both participating not constitute a program change but a practices or episodes among the and non-participating beneficiaries model test. In order to test the effect of participants and non-participant within a single site of care who would payments in the RO Model to determine comparators, understanding that any then need to operationalize 2 different whether they reduce cost while differences we may observe will be billing systems (one for participating maintaining and/or improving quality of observational and not causative. beneficiaries, one for non-participating care and patient outcomes, we believe Comment: A commenter requested beneficiaries) within that one site. using both a case (participant) and that CMS should publish online an Additionally, if the sample size control (non-participant) will provide explicit list of excluded RT providers (approximately 30 percent of episodes) the most meaningful comparison. We and RT suppliers, including their were calculated at the beneficiary level have designed the Model to include a names, addresses, and NPIs to ensure (rather than RT provider and supplier limited sample size (that is, there’s no confusion about excluded level), a substantially greater number of approximately 30 percent of eligible providers and suppliers. This RT providers and suppliers would be episodes nationwide), while ensuring commenter further stated that it is included as RO participants to reach the both sufficient sample size and power to important for Professional participants necessary approximately 30 percent produce robust data that can provide to have a CMS-approved list that clearly sample size. We are finalizing as evidence to certify the Model in the indicates which RT providers and RT proposed that patients will be RO future if the Department chooses. suppliers are excluded despite the fact beneficiaries if they receive included RT Comment: A few commenters that they are located within a ZIP Code services from an RO participant. The encouraged us to allow public comment selected for the RO Model. Model will be finalized using the

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proposed random selection of CBSAs as but not limited to Medicare Advantage provided in either the experimental or the method of determining an RT plans; the control arms of a clinical trial.30 provider’s or RT supplier’s participation • Is Enrolled in a PACE plan; Medicare pays routine costs by way of (or not) in the model. • Is in a Medicare hospice benefit FFS payments, making it appropriate to After considering public comments, period; 29 or include RT services furnished for RO we are finalizing with modification our • Is covered under United Mine episodes in this case under the RO proposed provisions on the RO Model’s Workers. Model. geographic unit of selection. We explained in the proposed rule We stated that the RO Model’s design Specifically, we are codifying at that the RO Model will evaluate RT would not allow RO beneficiaries to § 512.210(d) that we will randomly services furnished to beneficiaries who ‘‘opt out’’ of the Model’s pricing select CBSAs to identify RT providers have been diagnosed with one of the methodology. A beneficiary who is and RT suppliers to participate in the cancer types identified as satisfying our included in the RO Model pursuant to Model through a stratified sample criteria for inclusion in the Model, as the proposed criteria would have his or design. However, instead of allowing for discussed in section III.C.5.a of the rule her RT services paid for under the participant and comparison groups to (84 FR 34496 through 34497). Thus, we Model’s pricing methodology and contain approximately 40 percent of all stated that we believed it would be would be responsible for the eligible episodes in eligible geographic necessary to include only beneficiaries coinsurance amount as discussed in areas as we had proposed, we are who have at least one of the identified section III.C.6.i of this final rule. modifying this provision in the final cancer types and who also receive RT Beneficiaries do have the right to choose rule allowing for participant and services from RO participants. We also to receive RT services in a geographic comparison groups to contain stated that a key objective of the RO area not included in the RO Model. approximately 30 percent of all eligible Model is to evaluate if and/or how RT We explained in the proposed rule, at episodes in eligible geographic areas service delivery changes, in either the 84 FR 34497, that if an RO beneficiary (that is, CBSAs). The sample size was HOPD or freestanding radiation therapy stops meeting any of the eligibility calculated incorporating the final center setting, as a result of a change in criteria or triggers any of the exclusion parameters of the model, and we are payment systems from FFS to criteria before the TC of an episode using a sample size that we believe is prospectively determined bundled rates initiates, then the episode would be an necessary to detect the anticipated for an episode. We proposed these incomplete episode as discussed in impact of the model. Therefore, we are criteria in order to limit RT provider section III.C.6.a of the proposed rule (84 finalizing that approximately 30 percent and RT supplier participation in the RO FR 34503 through 34504) and this final of eligible episodes will be randomly Model to beneficiaries whose RT rule. Payments to RO participants selected for this Model. For the final providers and RT suppliers would would be retrospectively adjusted to rule, we used Medicare FFS claims from otherwise be paid by way of traditional account for incomplete episodes during January 1, 2016 through December 31, FFS payments for the identified cancer the annual reconciliation process, as 2018 for constructing episodes, types. We discussed our belief that these described in section III.C.11 of the determining sufficient sample size, and eligibility criteria for RO beneficiaries proposed rule and this final rule. We for the eventual selection of participants are necessary in order to properly proposed that if traditional Medicare and comparators for the RO Model, as evaluate this change with minimal stops being an RO beneficiary’s primary this was the timeliest data available at intervening effects in the proposed rule. payer after the TC of the episode has the time of this final rule’s release. We proposed to define a beneficiary been initiated, then regardless of who meets all of these criteria, and who whether the beneficiary’s course of RT 4. Beneficiary Population does not trigger any of the beneficiary treatment was completed, the 90-day In the proposed rule at 84 FR 34496, exclusion criteria, a ‘‘RO beneficiary’’. period would be considered an we proposed that a Medicare FFS We proposed to codify the terms ‘‘RO incomplete episode, and the RO beneficiary would be included in the beneficiary,’’ ‘‘RT provider,’’ and ‘‘RT participant would receive only the first RO Model if the beneficiary: supplier’’ at § 512.205. installment of the episode payment. In • Receives included RT services in a In addition, we proposed to include the event that a beneficiary dies or five-digit ZIP Code, linked to a CBSA in the RO Model any beneficiary enters hospice during an episode, then selected for participation, from an RO participating in a clinical trial for RT the RO participant would receive both participant during the Model services for which Medicare pays installments of the episode payment, performance period for a cancer type routine costs, provided that such regardless of whether the RO that meets the criteria for inclusion in beneficiary meets all of the beneficiary beneficiary’s course of RT has ended the RO Model; and inclusion criteria. The proposed rule (see section III.C.7 of the proposed rule • At the time that the initial treatment provides that we would consider and this final rule). planning service of the episode is routine costs of a clinical trial to be all We proposed these beneficiary furnished by an RO participant, the items and services that are otherwise eligibility criteria for purposes of beneficiary: generally available to Medicare determining beneficiary inclusion in ++ Is eligible for Medicare Part A and beneficiaries (that is, there exists a and exclusion from the Model. The enrolled in Medicare Part B; and benefit category, it is not statutorily following is a summary of comments ++ Has traditional Medicare FFS as excluded, and there is not a national received related to our proposal on the his or her primary payer. non-coverage decision) that are RO Model’s beneficiary population and In addition, we proposed to exclude our responses to those comments: from the RO Model any beneficiary 29 Please note that this was incorrectly stated in Comment: A few commenters who, at the time that the initial the section III.C.4 of the preamble to the Notice of requested that all patients enrolled in treatment planning service of the Proposed Rulemaking, as ‘‘Is not in a Medicare clinical trials should be excluded from episode is furnished by an RO hospice benefit period’’ (at 84 FR 34496), but was participant: correctly stated in the proposed regulatory text at • 84 FR 34585. It has been corrected in the preamble 30 The current Medicare policy on routine cost in Is Enrolled in any Medicare to this Final Rule to ‘‘Is in a Medicare hospice clinical trials is described in Routine Costs in managed care organization, including benefit period.’’ Clinical Trials 100–3 section 310.1.

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the RO Model. One of these commenters objective of the RO Model would be to choice because beneficiaries have the also stated that some Medicare evaluate if and/or how RT service right to choose to receive RT services contractors provide exceptions to delivery changes in either the HOPD or from a RT provider and/or RT supplier providers and suppliers with a history freestanding radiation therapy center not included in the RO Model. of evidence development and they setting as a result of a change in Comment: A commenter supported suggested that the Innovation Center payment systems from that of FFS under the participant criteria with the consider this as a basis for exclusion as OPPS or PFS, respectively, to that of exception of excluding those in a well. prospectively determined bundled rates Medicare hospice benefit (MHB) period. Response: We thank the commenters for an episode as described in section This commenter stated that such for their suggestions. Medicare pays III.C.6.c. We proposed these beneficiary patients may benefit from RT services as routine costs by way of FFS payments criteria in order to limit participation in a palliative measure and so should be for Medicare beneficiaries participating the RO Model to beneficiaries whose RT allowed to participate in this Model if in clinical trials when there exists a providers and/or RT suppliers would so. They further stated that while they benefit category, it is not statutorily otherwise be paid by way of traditional agreed this is a reimbursement issue for excluded, and there is not a national FFS payments for the identified cancer hospices, palliative radiation is by its non-coverage decision, making it types. We believe that these eligibility nature not curative and so should be appropriate to include these criteria for RO beneficiaries are covered under the MHB, at least for beneficiaries in the RO Model provided necessary in order to properly evaluate those people with cancer participating that such beneficiary meets all of the this change with minimal intervening in this Model. proposed beneficiary inclusion criteria. effects; therefore, we are not including Response: We thank the commenter It is important that the RO Model additional payers such as Medicare for their recommendation. Medicare include clinical trials because the goal Advantage to the RO Model in this final beneficiaries will be excluded from the of the Model is to test whether rule. We recognize that other payers RO Model if they are in a MHB period prospective episode payments for RT may be conducting similar alternative at the start of their receipt of RT services, in lieu of traditional FFS payment models. Other payers who are services, because the MHB is not paid payments, would reduce Medicare interested in testing an alternative FFS. As we previously stated, the goal expenditures. Therefore, not including payment system to FFS are welcome to of the RO Model is to test whether clinical trials that are paid through FFS align with our RO Model prospective episode payments in lieu of could skew the Model results. With methodologies. However, we are not traditional FFS payments for RT regard to the commenter who suggested soliciting formal partnerships with other services would reduce Medicare that the Innovation Center provide payers at this time. expenditures; therefore, it is important exceptions to providers and suppliers Comment: Another commenter that non-FFS beneficiaries be excluded with a history of evidence development, requested clarification on what will in order to properly evaluate the results we appreciate the suggestion, however, happen if a patient joins a Medicare of the Model. Traditionally, if a we believe that less experienced RO Advantage plan during the fall open beneficiary receives RT services during participants will benefit from this type enrollment period while in an RO a MHB period, the cost of the treatment of experience through peer-to-peer episode. This commenter expressed would be covered under the Medicare learning activities and performance concern that both systems will assume hospice per diem. The RO Model allows reports that will allow for comparison the other will pay. between participants. We also believe Response: In this scenario, if for RO Model payments to continue (in that including providers and suppliers Medicare FFS stops being the primary addition to the Medicare hospice per with all levels of experience would payer during the 90-day episode, this diem) if a beneficiary selects MHB result in a more robust data set for would be considered an incomplete during an RO episode so as not to evaluation of the RO Model’s episode. Please refer to section III.C.6.a dissuade RO participants from making a prospective payment approach. We will of the proposed rule (84 FR 34503 hospice referral when needed. The continue to monitor the Model for a through 34504) and this final rule for an Medicare hospice agency will not be need of this exception in the future. overview of our incomplete episode responsible for the cost of RT services Comment: A commenter suggested policy. in this case. This RO Model policy does that CMS should open the RO Model to Comment: A commenter stated that not intend to imply that the MHB voluntary participation by Medicare patients should always have a choice in should pay for curative treatment. While Advantage plans and other payers. This their care, and therefore a patient opt- we understand the commenter’s commenter stated that limiting the RO out provision is warranted just as it is concern, we will not be creating an Model to Medicare fee-for service would in the OCM. exemption of this nature at this time. miss an opportunity to allow as many Response: As we stated in the Comment: A commenter requested health care providers and payers as proposed rule, the RO Model’s design clarification on the definition of an RO possible to explore and assess will not allow RO beneficiaries to ‘‘opt beneficiary, specifically they would like innovative approaches to delivering care out’’ of the Model’s pricing clarification on what happens if a under a bundled payment model. methodology as described in section patient starts an episode with inpatient Response: At this time, we are III.C.6 of the proposed rule, as well as treatment and then changes to an finalizing as proposed that the RO this final rule. Of note, this policy is the outpatient setting, and if a patient Model will include only Medicare fee- same as in OCM, where beneficiaries changes ZIP Codes during the course of for-service beneficiaries receiving RT who receive care from an OCM treatment. services by RO Participants. This Model participant have the same Medicare Response: To the commenter’s was designed to test an alternative rights and protections, including the question regarding moving from payment approach instead of FFS, and right to choose which health care inpatient treatment to outpatient is therefore limited to only Medicare provider they see, and they may choose treatment, if a beneficiary starts FFS beneficiaries and does not include a health care provider who does not inpatient treatment and then changes to other payers like Medicare Advantage. participate in the OCM. However, just as an outpatient setting, this situation As we discussed in the NPRM, a key in OCM, this Model protects beneficiary would not be considered an RO episode,

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and treatment would be billed under incomplete episode. We also note that severity, and the related differences in traditional fee-for-service. in the case of incomplete episodes, RO technology in the monitoring and For the commenter’s question about a participants are owed beneficiary evaluation of this Model. patient changing ZIP Codes during the coinsurance payment of 20 percent of After considering public comments, course of treatment, we note that the ZIP the FFS amounts that would have been we are finalizing our proposal on the Codes are relevant only to the location paid in the absence of the RO Model, beneficiary population with of the RO participant, not the residence except when the RO beneficiary ceases modification. We have made additional of the beneficiary. If the beneficiary to have traditional FFS Medicare as his non-substantive changes to the with an included cancer type receives or her primary payer at any time after proposed provisions at § 512.215 in this included professional and technical the initial treatment planning service is services from one or more RO furnished and before the date of service final rule to improve readability. participants located in one or more ZIP on a claim with an RO Model-specific Specifically, we are finalizing, with Codes linked to CBSAs selected for HCPCS code and EOE modifier. In that modification, the RO Model beneficiary participation, then the beneficiary will case, the RO participant would be owed inclusion criteria as codified at be an RO beneficiary. If the beneficiary beneficiary coinsurance payment would § 512.215(a) and illustrated in Figure A. receives professional RT services from equal 20 percent of the first installment We have made additional non- an RO participant in a ZIP Code linked of the episode payment amount. See substantive changes to the proposed to CBSAs selected for participation, but III.C.6.a of the proposed rule (84 FR provisions at § 512.215 in this final rule receives technical RT services from non- 34503 through 34504) and this final rule to improve readability. We are also participants (or vice versa), the for an overview of our incomplete finalizing with modification at beneficiary will not be in the Model, episode policy. Payments to RO § 512.215(a) that an individual is an RO and this will be an incomplete episode participants will be retrospectively beneficiary if the individual receives as defined at § 512.205 and as further adjusted to account for incomplete included RT services from an RO described in section III.C.6.a of this final episodes during the annual participant that billed the SOE modifier rule. Payments to RO participants will reconciliation process, as described in for the PC or TC of an RO episode be retrospectively adjusted to account section III.C.11. of this proposed rule. during the Model performance period for incomplete episodes during the Comment: A commenter requested for an included cancer type. An annual reconciliation process, as clarification about what will occur if a individual is an RO beneficiary if, at the described in section III.C.11 of this final beneficiary refuses to participate in the time that the initial treatment planning rule. Model by notifying CMS in writing after service of an RO episode is furnished by Comment: A commenter did not treatment is started and the start of an RO participant, the individual is support our proposal regarding the episode (SOE) HCPCS is submitted to eligible for Medicare Part A and beneficiaries that will be included and CMS. enrolled in Medicare Part B, the excluded from the RO Model. This Response: We would like to clarify individual has traditional FFS Medicare commenter stated that linking that under this Model, RO beneficiaries as his or her primary payer (for beneficiaries by ZIP Code could create will not provide direct notification to example, is not enrolled in a PACE plan, adverse selection and skew the results CMS when they do not wish to Medicare Advantage or another of the Model. This commenter requested participate in the Model. If a beneficiary managed care plan, or United Mine clarity on whether inclusion and does not wish to ‘‘participate’’ in the Workers insurance), and if the exclusion is linked to the beneficiary’s Model, (s)he can seek treatment from a individual is not in a MHB period. We address being in the ZIP Code or the non-participant. The notification that are further finalizing with modification address of the RO participant. This we believe this commenter is referring at § 512.215(b) that any individual commenter also requested clarification to is in cases where beneficiaries do not enrolled in a clinical trial for RT about whether the RO participant is wish to have their claims data shared services for which Medicare pays responsible for the entire ZIP Code even with the RO participant for care routine costs will be an RO Beneficiary if the beneficiary goes out-of-area. coordination and quality improvement if the individual satisfies all of the Response: We are clarifying that a purposes under the Model. In such beneficiary inclusion criteria codified at beneficiary’s address does not cases, the RO participant must notify § 512.215(a). determine his or her inclusion in the RO CMS in writing within 30 days of when Model, rather it is determined by the the RO beneficiary notifies the RO Additionally, we are finalizing as address where the RO participant participant (see section III.C.15 of the proposed to codify the terms ‘‘RT furnished the included RT services. Nor proposed rule and this final rule for provider,’’ and ‘‘RT supplier’’ at did we propose to link beneficiaries by more details on this policy). § 512.205. We are finalizing, with ZIP Code. Regarding the requested Comment: A commenter was modification, to codify the term ‘‘RO clarification about whether the RO concerned with the potential for adverse beneficiary’’ at § 512.205 to mean a participant is responsible for the entire health outcomes for certain vulnerable Medicare beneficiary who meets all of ZIP Code even if the beneficiary goes populations defined by race, income, the beneficiary inclusion criteria at ‘‘out-of-area’’, we take the commenter’s and the presence of prostate cancer § 512.215(a) and whose RO episode reference to a beneficiary going ‘‘out-of- under the Model. meets all of the criteria defined at area’’ to mean that the beneficiary has Response: The evaluation of the RO § 512.245. As explained in the proposed switched providers and stopped Model will be taking into account, to the rule and in this final rule, the RO receiving RT services from the RO extent feasible, any potential adverse Model’s design would not allow RO participant that initiated the RO health outcomes, and any underlying beneficiaries to ‘‘opt out’’ of the Model’s episode. This would be considered an differences in patient characteristics, pricing methodology.

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FIGURE A—FINALIZED RO BENEFICIARY INCLUSION CRITERIA

The individual receives included RT services: • From an RO participant that billed the SOE modifier for the PC or TC of an RO episode during the Model performance period for an in- cluded cancer type.

At the time that the initial treatment planning service of the RO episode is furnished by an RO participant, the individual: • Is eligible for Medicare Part A and enrolled in Medicare Part B. • Has traditional Medicare FFS as his or her primary payer (for example, is not enrolled in a PACE plan, Medicare Advantage or another managed care plan, or United Mine Workers insurance). • Is not in a Medicare hospice benefit period.

5. RO Model Episodes Medicare claims data was sufficiently episode. Thus, skin cancer was We proposed that under the RO reliable to calculate prices for excluded in the proposed rule. Model, Medicare would pay RO prospective episode payments that The proposed RO Model’s included participants a site-neutral, episode- accurately reflect the average resource cancer types are commonly treated with based payment amount for all specified utilization for an episode. These cancer RT and can be accurately priced for RT services furnished to an RO types are made up of specific ICD–9 and prospective episode payments. As beneficiary during a 90-day episode (84 ICD–10 diagnosis codes. For example, as proposed, an up-to-date list of cancer FR 34497). In section III.C.5 of the shown in Table 1 of the proposed rule, types, upon any subsequent revisions, proposed rule, we first explained our there are cancer types for ‘‘breast will be kept on the RO Model website. proposal to include criteria to add or cancer’’ and ‘‘prostate cancer,’’ which We proposed to define the term remove cancer types under the Model are categorical terms that represent a ‘‘included cancer types’’ to mean the grouping of ICD–9 and ICD–10 codes and their relevant diagnoses codes in cancer types determined by the affiliated with those conditions. To the Model as well as the RT services and proposed criteria set forth in § 512.230, identify these cancer types and their modalities that would be covered and which are included in the RO Model relevant diagnosis codes to include in not covered in an episode payment for test. the Model, we identified cancers that We proposed to maintain the list of treatment of those cancer types. We then are treated with RT. ICD–10 codes for included cancer types explained our proposal for testing a 90- As described in the proposed rule, we under the RO Model on the RO Model day episode and proposed the used the list of cancer types and website. We indicated in the proposed conditions that must be met to trigger an relevant diagnosis codes, to analyze the rule that any addition or removal of episode. interquartile ranges of the episode these codes would be communicated via a. Included Cancer Types prices across diagnosis codes within the RO Model website and written We proposed the following criteria for each cancer type to determine pricing correspondence to RO participants. We purposes of including cancer types stability. We chose to exclude benign proposed to notify RO participants of under the RO Model. The cancer type— neoplasms and those cancers that are any changes to the diagnosis codes for • Is commonly treated with radiation; rarely treated with radiation because the included cancer types per the CMS and there were not enough episodes for standard process for announcing coding • Has associated current ICD–10 reliable pricing and they were too changes and update the list on the RO codes that have demonstrated pricing variable to pool. Model website no later than 30 days stability. We stated in the proposed rule that prior to each PY. We proposed to codify these criteria during our review of skin cancer We solicited comments on the episodes, we discovered that Current proposed cancer types included in the for included cancer types at § 512.230(a) ® ® of our regulation. Procedural Terminology (CPT ) code RO Model. The following is a summary We proposed the following criteria for 0182T (electronic brachytherapy of the public comments received on this purposes of removing cancer types treatment), which was being used proposal and our responses to those under the RO Model. mainly by dermatologists to report comments: • RT is no longer appropriate to treat treatment for non-melanoma skin Comment: A couple of commenters a cancer type per nationally recognized, cancers, was deleted and replaced with expressed support for the inclusion of ® evidence-based clinical treatment two new codes (CPT code 0394T to all 17 cancer types named in the guidelines; report high dose rate (HDR) electronic proposed rule, emphasizing that it • CMS discovers a ≥10 percent skin brachytherapy and 0395T to report expands the benefit to the broadest (≥10%) error in established national HDR electronic interstitial or population of patients. A few of these base rates; or intracavitary treatments) in 2016. Local commenters stated that including all 17 • The Secretary determines a cancer coverage determinations (LCDs) that cancer types would reduce the overall type not to be suitable for inclusion in provide information about whether or administrative burden on RO the Model. not a particular item or service is participants, as this scale decreases the We proposed to codify these criteria covered were created and subsequently burden associated with operationalizing for removing cancer types at changed during this time period. Our a model for a few key cancer sites and § 512.230(b) of our regulation. analysis suggested that the volume and not others. Other commenters We identified 17 cancer types in pricing of these services dropped emphasized that, since these 17 cancer Table 1—Identified Cancer Types and significantly between 2015 and 2016, types are commonly treated with RT Corresponding ICD–9 and ICD–10 Codes with pricing decreasing more than 50 services, they can be accurately priced. of the proposed rule that met our percent. As a result, we did not believe Response: We thank the commenters proposed criteria. We explained in the that we could price episodes for skin for their support. proposed rule that these 17 cancer types cancers that accurately reflect the Comment: A commenter described are commonly treated with RT and average resource utilization for an how inaccurate coding could lead to

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misvalued episode payments and APC methodology with regard to low percentage indicated that liver included renal cell carcinoma in one of brachytherapy and cervical cancer and cancer treated with brachytherapy the examples. determined that it provides appropriate should fall under the ‘‘certain Response: Based on further clinical reimbursement. For examples, please brachytherapy surgical services’’ review, kidney cancer is not commonly see the CY 2020 OPPS/ASC final rule excluded by the proposed rule due to treated with radiotherapy and as such it with comment period (84 FR 61163) and low volume. does not meeting the criteria for the CY 2019 OPPS/ASC final rule with Response: As noted in section III.C.5.c inclusion. Kidney cancer may have been comment period (83 FR 58843). As of this final rule, we are removing included as an artifact of inaccurate such, we believe that the C–APC Yttrium-90 from the RT services coding and we are therefore excluding methodology is appropriate to use in the included on the list referred to as ‘‘RO it from the RO Model. base rate calculations for the RO Model. Model Bundled HCPCS’’ (Table 2; as Comment: Many commenters We will continue to examine these such, it may be billed FFS. Liver cancer expressed concern over the inclusion of concerns. Please refer to the pricing meets the criteria for inclusion as a cervical cancer. A commenter suggested methodology in section III.C.6 for cancer type under the RO Model as separate payment for each physician further explanation of these points, codified at § 512.230(a). The RO Model involved in treating cervical cancer. A including rationale related to APCs and is designed to be disease-specific and few commenters recommended using C–APCs. We rely on Medicare providers agnostic to treatment and modality type. the OPPS Ambulatory Payment and suppliers to furnish appropriate Liver cancer is commonly treated with Classification (APC) payment rates care to beneficiaries. radiation and has associated current without the comprehensive APC (C– Comment: A commenter suggested ICD–10 codes that demonstrate pricing APC) methodology for the technical adding a specific category for an stability. It is important to note, that component of the national base rate for isolated lymph node treated with when just one treatment is clinically cervical cancer, because they believe radiation, emphasizing that this is a appropriate and furnished, the RO that the C–APC OPPS methodology common clinical situation. participant will be paid more than they undervalues the brachytherapy Response: We thank the commenter would have under FFS. CMS recognizes reimbursement. Another commenter for their suggestion. However, we that there is no efficiency or savings to called into question the data used to believe that the treatment of an isolated be earned in these instances, but by determine the national base rates for lymph node would likely be part of a including liver cancer in the RO Model cervical cancer, stating that the payment treatment plan for an included cancer we will be able to test whether methodology is not well-suited for type. If it is not part of a treatment plan prospective payments for RT services, as cancers commonly treated with multiple for an included cancer type, the opposed to traditional FFS payments, modalities. This commenter also treatment would be paid FFS. would reduce Medicare expenditures believed that the RO Episode File Comment: A few commenters while preserving or enhancing quality of misattributed episodes to cervical recommended that CMS remove liver care. Thus, we are finalizing our cancer that ought to have fallen under cancer from the RO Model. These proposal to include liver cancer in the a different cancer type. This commenter commenters argued that the treatments RO Model. noted episodes that are inconsistent for liver cancer are not well-suited for Comment: Some commenters with clinical medicine and could be the RO Model as treatment can involve recommended that CMS implement the only partially captured episodes, multiple physicians. A few commenters Model with fewer cancer types. A incorrectly captured delivery codes, or stated that liver cancer sometimes commenter suggested that CMS limit the misattributed episodes. Regarding involves radioembolization treatment number of cancer types to those for misattribution, the commenter stated using Yttrium-90, and that this therapy which treatment protocols are the most that approximately 2 percent of cervical frequently involves both a radiation standardized across patient cohorts and cancer episodes include SRS, yet since oncologist and an interventional with low propensity for outlier cases. A SRS is a single fraction of radiation to oncologist, most likely in the HOPD. couple of these commenters expressed the brain, these episodes are likely These commenters believed that concerns that the administrative burden treating a metastatic site rather than including this therapy could trigger imposed by the sheer number of treating the primary site of cervical incomplete episodes, as one physician included cancer types would be too cancer. Regarding partially captured is typically involved in planning and a much for RO participants and CMS to episodes, the commenter asserted that second in delivery. These commenters manage effectively. A commenter noted there are 75 episodes from the RO also believed that, when the radiation the variation in treatment pathways and Episode File where fewer fractions were oncologist triggers the episode, there requested that CMS consider excluding provided than is the established clinical would be a separate FFS payment to the treatments that are extensive or serve as approach. interventional radiologist for their work, outliers. These commenters indicated Response: We believe that the ultimately resulting in a higher payment that focusing on fewer cancer types national base rates represent the average from the patient. would allow providers and suppliers to of all RT services provided to Other commenters believed that liver focus efforts on specific areas of beneficiaries with a given cancer type, cancer should be excluded from the medicine, causing less disruption to RO including cervical cancer, and it is Model, as it is uncommon for a patient participants. probable that there will be individual to receive more than one session of A few of these commenters had episodes where there is deviation from brachytherapy for liver cancer, thus specific recommendations for which the standard treatment given the clinical there is no opportunity to improve subset of cancer types should be profile of an individual patient. Our efficiency or reduce spending. A couple included. A couple of commenters data shows that in addition to episodes of commenters added that liver cancer suggested targeting the most prevalent with lower numbers of fractions, there treated with brachytherapy accounts for cancer types: Breast, colon, lung, and are other episodes with higher numbers only 0.29 percent of all episodes prostate, as treatments for these cancers of fractions than is typically included in the Model, and, therefore, are often more homogenous and their recommended. Over the past few years, any cost savings would be trivial. costs are more predictable. A few other we have repeatedly examined the C– Another commenter suggested that this commenters recommended including

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only cancer types that had sufficient individual episodes where there is that the RO Model requirements and clinical data to support deviation from the standard treatment billing guidance would apply to a subset hypofractionation as clinically given the clinical profile of an of their RT services rather than to than appropriate care. A few commenters individual patient. Our data shows that, to the majority of their RT services for recommended excluding complex in addition to episodes with lower a significant portion of the Model cancer types with variable costs, such as numbers of fractions, there are other performance period (or if cancer types cancers of the brain and of the head and episodes with higher numbers of were further limited, for the entire neck. Specifically, commenters fractions than is typically Model performance period). emphasized that these cancer types recommended, including but not As explained earlier in this section of frequently require more complicated limited to as cancers of the brain and of the final rule, we are modifying the list workup, planning, and technology than the head and neck. The final list of included cancer types to exclude others, and must be adjusted as the includes those cancer types that are kidney cancer. We believe that tumor shrinks or the patient loses commonly treated with RT and have including the 16 cancer types (Anal weight. A commenter underscored that, demonstrated pricing stability, which Cancer, Bladder Cancer, Bone even within these three cancer types, allows them to be accurately priced. The Metastases, Brain Metastases, Breast patients may receive treatments that diagnoses selected to be included in the Cancer, Cervical Cancer, CNS Tumors, vary widely in cost based on clinical RO Model account for over 90 percent Colorectal Cancer, Head and Neck indicators. of episodes during the time period that Cancer, Liver Cancer, Lung Cancer, A couple of commenters suggested was analyzed (2016–2018, as discussed Lymphoma, Pancreatic Cancer, Prostate phasing in the 17 cancer types over in section III.C.6.d). CMS believes that Cancer, Upper GI Cancer, and Uterine time, beginning with one or two cancer phasing in the included cancer types Cancer) that are commonly treated with types and then expanding to the full set would prevent a robust evaluation RT and that can be accurately priced for of 17 over the Model performance because doing so would reduce the prospective episode payments, is the period. A couple commenters suggested amount of available data for any cancer best design for testing an episodic APM reducing the number of cancer types types phased in at a later time. As for RT services. The list of ICD–10 codes included and analyzing performance previously stated, we believe that a data before including all 17 cancer types for the included cancer types under the Model performance period of at least 5 from the outset of the Model. RO Model, upon any subsequent Response: The 16 cancer types that years is sufficient to obtain data to revisions, can be located on the RO we are finalizing for inclusion in the RO compute a reliable impact estimate. Model website. Model are cancers commonly treated Please refer to section III.C.1 of the rule After considering public comments, with RT. The Innovation Center for more information on the Model we are finalizing, without change, our excluded those cancers that are rarely performance period. proposed criteria for included cancer treated with radiation. Once an initial Additionally, CMS believes that types and for removing cancer types at list of cancer types and relevant limiting or phasing in the number of § 512.230(a) and (b) of our regulations. diagnosis codes were identified, the included cancer types would be more Additionally, we are finalizing without Innovation Center reviewed them for burdensome for most RO participants. change at § 512.230(c) our proposal to pricing stability. For example, the As previously noted, the included notify RO participants of any changes to Innovation Center analyzed the diagnoses accounted for over 90 percent the diagnosis codes for the included interquartile ranges of the episode of episodes from 2016 through 2018. cancer types by displaying them on the prices across diagnosis codes within Thus, for most RO participants, limiting RO Model website no later than 30 days cancer types. There will likely be or phasing in cancer types would mean prior to each performance year.

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b. Episode Length and Trigger standard length of a course of RT, we met: (1) There is an initial treatment (1) Episode Length analyzed Medicare claims for planning service (that is, submission of beneficiaries who received any RT treatment planning HCPCS codes We proposed to define the length of services between January 1, 2014 and 77261–77263, all of which would be an episode under the RO Model as 90 December 30, 2015. Preliminary included in the PC) furnished by a days (84 FR 34498). Based on the analysis showed that average Medicare Professional participant or a Dual analysis of Medicare claims data spending for radiation treatment tends participant; and (2) at least one between January 1, 2014 and December to drop significantly 9 to 11 weeks radiation treatment delivery service (as 30, 2015, approximately 99 percent of following the initial RT service for most listed in the proposed rule at Table 2) beneficiaries receiving RT completed diagnoses, including prostate, breast, is furnished by a Technical participant their course of radiation within 90 days lung, and head and neck cancers. or a Dual participant within the of their initial treatment planning Furthermore, based on this data, following 28 days. The PC is attributed service. We proposed that Day 1 would approximately 99 percent of to the RT supplier of the initial be the date of service that a Professional beneficiaries receiving RT completed radiation treatment planning service. participant or Dual participant furnishes their course of radiation within 90 days The TC is attributed to the RT provider the initial treatment planning service of their initial treatment planning or RT supplier of the initial radiation (included in the PC), provided that a service. As we stated in the proposed treatment delivery service. As we Technical participant or Dual rule, we made a summary-level, de- explained in the proposed rule, an participant furnishes an RT delivery identified file titled ‘‘RT Expenditures episode that is triggered will end 89 service (included in the TC) within 28 by Time’’ available on the RO Model’s days after the date of the initial days of the treatment planning service. website (https://innovation.cms.gov/ treatment planning service, creating a In other words, the relevant 90-day initiatives/radiation-oncology-model/) 90-day episode. If, however, a period would be considered an episode that supports our findings in this beneficiary receives an initial treatment only if a Technical participant or Dual preliminary analysis. planning service but does not receive participant furnishes the TC to an RO Based on our proposed rule analysis, RT treatment from a Technical beneficiary within 28 days of when a for the purpose of establishing the participant or Dual participant within Professional participant or Dual national base rates for the PC and TC of 28 days, then the requirements for participant furnishes the PC to such RO each episode for each cancer type, triggering an episode would not be met, beneficiary. As we explained in the episodes were triggered by the and no RO episode will have occurred, proposed rule, when those occurrence of a treatment planning and the proposed incomplete episode circumstances occur, the ‘‘start’’ of the service followed by a radiation policy would take effect. episode would be the date of service treatment delivery service within 28 In those instances where the TC of an that the initial treatment planning days of the treatment planning service episode is not furnished by a Dual service was rendered. If, however, a (HCPCS codes 77261–77263). In participant (that is, when the same RO Technical participant or Dual addition, for the purpose of establishing participant does not furnish both the PC participant does not furnish the TC to the national base rates in section and the TC of an episode), we proposed an RO beneficiary within the 28-day III.C.6.c, the episodes lasted for 89 days that the Professional participant would period, then no episode would have starting from the day after the initial provide the Technical participant with occurred and any payment will be made treatment planning service in order to a signed radiation prescription and the to the RO participant in accordance create a full 90-day episode. Based on final treatment plan, all of which is with our incomplete episode policy. these analyses, we proposed a 90-day usually done electronically. This will (See 84 FR 34498 through 34499.) We episode duration. inform the Technical participant of the refer readers to sections III.C.5.b and episode start date. III.C.6 of the proposed rule and this (2) Episode Trigger (3) Policy for Multiple Episodes and the final rule for an overview of our episode Because we only want to include Clean Period trigger and incomplete episode policies, episodes in which beneficiaries actually respectively. receive RT services, we proposed that Given our proposed rule findings that As discussed in the proposed rule (84 an episode would be triggered only if 99 percent of Medicare FFS FR 3499), to better understand the both of the following conditions are beneficiaries complete treatment within

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90 days of the initial treatment planning period is unduly focused on short-term might limit patient access to life- service, and to minimize any potential gains, failing to capture the medium- extending treatment protocols. incentive for an RO participant to and long-term benefits and savings from Response: We believe that the RO extend a treatment course beyond the treatment modalities like PBT. A few Model pricing methodology, with its 90-day episode in order to trigger a new commenters also suggested that the reliance on historical experience and episode, we proposed that another financial disincentives created by the case mix adjustments, accounts for the episode may not be triggered until at RO Model would lead to long-term range of patient scenarios and provides least 28 days after the previous episode adverse clinical consequences and appropriate compensation to has ended (84 FR 34499). This is additional spending. A commenter participants. We rely on Medicare because, while a missed week of believed that short term savings would providers and suppliers to furnish treatment is not uncommon, a break be outweighed by longer term costs. appropriate care to our beneficiaries. As from RT services for more than four Response: We appreciate commenters’ finalized in section III.C.14, we will weeks (or 28 days) generally signals the concerns. We rely on Medicare monitor for unintended consequences of start of a new course of treatment.31 As providers and suppliers to furnish the RO Model including but not limited we explained in the proposed rule, we appropriate care to our beneficiaries. We to stinting on care. refer to the 28-day period after an expect Medicare providers and Comment: Some commenters episode has ended as the ‘‘clean suppliers to select the clinically recommended that CMS reconsider its period,’’ and during this time an RO appropriate treatment modality that will methodology in bundling multiple participant would bill for RT services confer the greatest short-, medium-, or treatments into a single episode, furnished to an RO beneficiary as FFS. long-term benefit on the beneficiary. factoring in the complexity of multiple We proposed to codify the term ‘‘clean And, we believe our payment eligible sites requiring treatment within period’’ at § 512.205 of our regulations. methodology, with its blend of national a 90-day period. Some commenters We proposed that if clinically rates with participant-specific case mix specifically suggested that participants appropriate, an RO participant may and historical experience, will provide should be eligible for multiple bundles initiate another episode for the same appropriate payment to incentivize if they treat distinct disease sites or beneficiary after the 28-day clean period high-value care, including the diagnoses within a 90-day episode of has ended. During the clean period, an appropriate treatment modality and care to accurately capture the costs of RO participant would be required to bill number of fractions. Thus, we do not multiple treatments. A commenter for RT services for the beneficiary in believe that the Model will lead to long- suggested that FFS payment should be accordance with FFS billing rules. We term adverse clinical consequences or permitted for treatment of metastases proposed that the Innovation Center additional spending. We will be within the 90-day episode as long as it would monitor the extent to which monitoring to ensure there are no is for a new site. A commenter services are furnished outside of 90-day unintended consequences. recommended eliminating the 90-day episodes, including during clean Comment: A commenter requested episode to reimburse providers and periods, and for the number of RO clarification on whether an episode of suppliers for separate courses of beneficiaries who receive RT in care includes any course of treatment radiation therapy within this period. multiple episodes. within 90 days or if an episode is Another commenter requested more We solicited public comment on our limited to a specific diagnosis. Another information about what happens to a proposal regarding episode length and commenter requested clarification course of treatment for a specific trigger. The following is a summary of regarding billing practices for patients diagnosis that lasts longer than 90 days. the public comments received on this who, within a 90-day episode, are found Response: We believe that the RO proposal and our responses to those to have new cancer sites with different Model pricing methodology, through the comments: HCPCS codes. historical experience and case mix Comment: Some commenters noted Response: We thank the commenter adjustments, will account for their concern that the 90-day episode for their question. An RO episode differences in RO participants’ historical period would inappropriately includes all included RT services (See care patterns and the demographic incentivize providers and suppliers to Table 2) furnished to an RO beneficiary characteristics of their patient reduce the number of fractions into the with an included cancer type during the populations and addresses the cost of shortest possible course of treatment. A 90-day episode as codified at §§ 512.205 treating multiple diagnoses or the cost commenter believed this would have and 512.245. RT services furnished to of multiple treatments. It is important to negative effects on research, as an RO beneficiary for any additional note that, if treatment goes beyond the encouraging providers and suppliers to diagnosis not specified on the list of end of 90 days, after the RO participant opt for the shortest length of treatment included cancer types, the RT provider bills the modifier indicating the end of possible would make it more difficult to and/or RT supplier would bill FFS for an RO episode (EOE) the additional RT study the optimal length of treatment for those services. services furnished will be billed and Comment: Many commenters believed different types of patients. Another paid FFS—this does not create an the 90-day episode period is not commenter suggested that this structure incomplete episode. sufficiently responsive to patients would disincentivize adoption of Comment: A couple commenters whose cancer might recur, metastasize, ground-breaking treatment paradigms. A recommended that CMS tailor episode require multiple treatment modalities, few commenters requested that CMS length to the likely pattern and timing or otherwise require additional consider the negative impact of the 90- of RT treatment for each cancer type. treatments within the 90-day period. A Response: We believe that the RO day episode on services with higher couple of commenters believed that the Model pricing methodology will upfront investment but longer term 90-day episode structure would adequately reimburse participants for value. A couple of these commenters incentivize participants to delay care or the patterns and timing of RT services suggested that the 90-day episode shift patients to other treatment, waiting during a uniform 90-day episode period. As previously stated, 99 percent of 31 CMS was advised by radiation oncologists to capture payment for those services in consulting on the design of the Model that four the clean period or a subsequent beneficiaries complete their RT course weeks signals the start of a new course of treatment. episode. A commenter believed this within 90 days. Although some cancer

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types might typically complete commenter, believing that the episodes treatment planning code and the first treatment in a period of time shorter do not match standard medically treatment delivery service in particular than 90 days, our data shows that while accepted episodes of care, scenarios. For example, a commenter significant expenditures occur through recommended that CMS create a stated that some cases of multi-radiation week 10 of an episode, additional separate category for palliative cases. modalities, like EBRT followed by expenditures occur throughout the Response: Based on the analysis of brachytherapy, require coordination remainder of the episode for all of the Medicare claims data between January with other specialties that might make included cancer types. (See RT 1, 2014 and December 30, 2015, it difficult to begin delivering treatment Expenditures by Time on the RO Model approximately 99 percent of within a 28-day episode trigger window. website.) As explained in section III.C.7, beneficiaries receiving RT completed Another commenter recommended that we have modified the billing their course of radiation within 90 days CMS remove the 28-day episode trigger requirements to allow the EOE claim to of their initial treatment planning window and instead trigger the first be submitted and paid at the completion service. The Model does include Brain episode payment at the completion of of a planned course of treatment, even Metastasis and Bone Metastasis as treatment planning and commencement when that course of treatment is shorter included cancer types. For the other of treatment delivery without any than 90 days. We believe that cancer types, our data shows that required timeline. participants will be reimbursed for their palliative treatment is included when Response: Our data show that services in an appropriate and timely RT services are being furnished to treat treatment almost always occurs within manner under this structure. the primary cancer type and secondary this time period. And, if it does not, this Comment: A few commenters voiced malignancies and metastases. Thus, we would constitute an incomplete concern about potential delays or breaks will not be creating a separate category episode. We are finalizing that an in therapy caused by adverse patient for palliative cases or altering the length episode will be triggered only if both of response or concurrent patient illness. A of the episode. the following conditions are met: (1) commenter believed that providers and Comment: A couple commenters There is an initial treatment planning suppliers could lose reimbursement for expressed support of the 28-day service (HCPCS codes 77261–77263) delivered services if a patient cannot window between the treatment planning furnished by a Professional participant tolerate treatment. A couple such code and the first treatment delivery or a Dual participant; and (2) at least commenters expressed that the breaks in service, finding this structure one radiation treatment delivery service treatment could extend the therapy reasonable. (See Table 2) is furnished by a beyond the 90-day end point, Response: We thank the commenters Technical participant or a Dual preventing timely EOE submission and for their support. participant within the following 28 resulting in an incomplete episode. This Comment: A commenter requested days. commenter recommended adjusting the clarification on how the planning and Comment: A commenter expressed EOE to the completion of the episode. simulation of treatment are designated concern about incomplete episodes Response: Such breaks in therapy will within an episode. In the event a patient resulting from planning services not cause an incomplete episode. It is receives multiple planning services provided by an RO participant and important to note that if treatment goes prior to the commencement of treatment provided in an ASC outside of beyond the end of 90 days, the RO treatment, this commenter wished to the Model, whether or not treatment is participant can bill the EOE and the know which planning service would be furnished within the 28-day episode additional RT services furnished will be considered the trigger and how multiple trigger window. billed and paid FFS. planning sessions are represented in the A couple of commenters requested Comment: A commenter noted that national base rates. A commenter clarification on how PC and TC claims each clinical scenario is different and expressed concern about claims will be paid if treatment is not delivered that physicians may have good reasons processing for multiple planning within the 28-day episode trigger for ordering more treatment sessions services furnished within a 90-day window. One such commenter advised with lower intensity. This commenter episode for metastases identified during that cash flow problems would result if believed that CMS should evaluate the the episode. This commenter providers and suppliers are required to specifics of a clinical scenario that falls emphasized that the resources expended wait until the reconciliation periods and outside the expected parameters as part for subsequent planning sessions are true-up periods to receive payment for of the agency’s data analysis. equivalent to those expended in the these incomplete episodes. For this Response: We appreciate this initial planning session. reason, this commenter recommended commenter’s concerns. We rely on Response: The treatment planning that CMS pay all CPT/HCPCS codes that Medicare providers and suppliers to service identified as the ‘‘first’’ are billed outside this 28-day episode furnish appropriate care to our treatment planning service is the trigger trigger window as FFS. beneficiaries. And, we believe that our for an episode and its corresponding Response: We thank the commenters cancer-specific bundles strike the right date of service marks the episode’s start for their inquiry. RT services furnished balance of capturing a range of clinical date. Subsequent planning sessions in an ASC are not included in the RO scenarios with little variability in occurring within a previously defined Model. Thus, if the planning service pricing to prohibit setting a base rate. As episode are indeed included in the was provided by a Professional described in section III.C.16, we will national base rates. Each treatment participant (in an HOPD or a monitor for unintended consequences of planning service furnished should be freestanding radiation therapy center) the RO Model. included on the no-pay claims and the treatment delivery was Comment: A commenter emphasized described in section III.C.7 and codified furnished in an ASC, an episode could that the episode length could reduce the at § 512.260(d). We will monitor be triggered but rendered incomplete, availability of palliative radiotherapy for utilization of services via these no-pay thus the planning services should be pain control, as some evidence suggests claims. billed FFS. If the TC is not rendered by that shorter courses of treatment lead to Comment: A few commenters a participant within 28 days, an episode increased need for additional treatment expressed concern about the 28-day will be considered incomplete and those and shortened pain control. Another episode trigger window between the services should be billed FFS. As noted

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in section III.C.7 of the proposed rule beneficiary, provided that a Technical aligning the patient with localization (84 FR 34512 through 34513) and this participant or the same Dual participant lasers, and/or designing immobilization final rule, we expect to provide RO furnishes a technical component RT devices for precise patient positioning. participants with additional instructions service to the RO beneficiary within 28 Technical preparation and special for billing, particularly as billing days of such RT treatment planning services: Technical preparation and pertains to incomplete episodes, service, with a modification to clarify special services include radiation dose through the Medicare Learning Network that the initial RT treatment planning planning, medical radiation physics, (MLN Matters) publications, model- service to the RO beneficiary be dosimetry, treatment devices, and specific webinars, and the RO Model furnished in a freestanding radiation special services. More specifically, these website. therapy center or an HOPD. We are services also involve building treatment Comment: A couple of commenters finalizing as proposed that the devices to refine treatment delivery and supported FFS payments for treatments circumstance in which an episode does mathematically determining the dose that exceed the 90-day episode period. not occur because a Technical and duration of radiation therapy. Response: We thank the commenters participant or a Dual participant does Radiation oncologists frequently work for their support. We will be finalizing not furnish a technical component to an with dosimetrists and medical as proposed in § 512.260 that an RO RO beneficiary within 28 days following physicists to perform these services. participant shall bill for any medically a Professional participant or the Dual Radiation treatment delivery services: necessary RT services furnished to an participant furnishing an initial Radiation treatment is usually furnished RO beneficiary during a clean period treatment planning service to that RO via a form of external beam radiation pursuant to existing FFS billing beneficiary qualifies as an incomplete therapy or brachytherapy, and includes processes in the OPPS and PFS. episode. In addition, we are finalizing as multiple modalities. Although treatment Comment: A commenter supported proposed at § 512.245(c) that an episode generally occurs daily, the care team the 28-day clean period between must not be initiated for the same RO and patient determine the specific episodes for all but one included cancer beneficiary during a clean period. timing and amount of treatment. The type, metastatic bone disease. Because treating physician must verify and metastatic bone disease often requires c. Included RT Services document the accuracy of treatment ongoing treatment, this commenter We proposed at 84 FR 34499 that the delivery as related to the initial suggested that RO participants have the RO Model would include most RT treatment planning and setup ability to initiate subsequent episodes services furnished in HOPDs and procedure. immediately after the prior episode freestanding radiation therapy centers. Treatment management: Radiation ends, eliminating the clean period. Services furnished within an episode of treatment management typically Response: We appreciate the RT usually follow a standard, clearly includes review of port films, review suggestion, but we do not want to defined process of care and generally and changes to dosimetry, dose provide a financial incentive for RO include a treatment consultation, delivery, treatment parameters, review participants to prolong or delay treatment planning, technical of patient’s setup, patient examination, treatment for bone metastasis or any preparation and special services and follow-up care. other clinical condition to initiate an (simulation), treatment delivery, and As discussed in the proposed rule (84 FR 34500), our claims analysis revealed additional episode. treatment management, which are also that beneficiaries received a varying Comment: A commenter categorical terms used to generally number of consultations from different recommended that the clean period be describe RT services. As outlined in the physicians prior to the treatment extended to 60 days to allow for proposed rule, the subcomponents of RT planning visit, which determines the treatment of secondary cancers. services have been described in the prescribed course of radiation therapy, Response: We appreciate the following manner: 32 comment, but CMS was advised by Consultation: A consultation is an including modality and number of treatments to be delivered. We proposed radiation oncologists consulting on the evaluation and management (E/M) to include treatment planning, technical design of the Model that four weeks service, which typically consists of a preparation and special services, typically signals the start of a new medical exam, obtaining a problem- treatment delivery, and treatment course of treatment. Therefore, we will focused medical history, and decision management as the RT services in an not be extending the clean period in this making about the patient’s condition/ episode paid for by CMS, and we final rule. care. Comment: A commenter requested Treatment planning: Treatment proposed to codify this at § 512.235. E/ clarification on billing practices for planning tasks include determining a M services are furnished by a wide range of physician specialists (for patients who complete one 90-day patient’s disease-bearing areas, example, primary care, general episode and then return with a new identifying the type and method of oncology, others) whereas the other diagnosis under their existing diagnosis radiation treatment delivery, specifying radiation services are typically only code within the clean period. areas to be treated, and selecting furnished by radiation oncologists and Response: As stated in sections radiation therapy treatment techniques. their team. This is reflected in the III.C.5.b(3) and III.C.7 of this final rule, Treatment planning often includes HCPCS code set used to bill for these any services provided during the 28-day simulation (the process of defining services. In our review of claims data for clean period would be paid FFS. relevant normal and abnormal target After considering public comments the proposed rule, many different types anatomy and obtaining the images and received, we are finalizing at § 512.205 of specialists furnish E/M services. It is data needed to develop the optimal the definition of RO episode. common for multiple entities to bill for radiation treatment process). Treatment Specifically, we are defining that an RO treatment consultations (E/M services) planning may involve marking the area episode means the 90-day period that for the same beneficiary, whereas to be treated on the patient’s skin, begins on the date of service that a typically only a single entity bills for RT Professional participant or a Dual 32 American Society for Radiation Oncology services for a beneficiary when we participant furnishes an initial RT (ASTRO). Basics of RO Coding. https:// limited the services considered to treatment planning service to an RO www.astro.org/Basics-of-Coding.aspx. treatment planning, technical

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preparation and special services, preparation and special services, (such as claims with HCPCS 77301 with treatment delivery, and treatment treatment delivery, and treatment payment amounts allowed), but we do management. When consultations and management for the included not assign payment rates to other claims visits were included for an analysis of modalities. As discussed in the with other HCPCS codes from the professional RT services during 2014– proposed rule, RT services included on baseline period that were denied (for 2016, only 18 percent of episodes this list are referred to as ‘‘RO Model example, in this example because they involved billing by a single entity (TIN Bundled HCPCS’’ when they are were in the range of HCPCS codes not or CCN) as opposed to 94 percent of provided during an RO Model episode allowed to be reported in addition to episodes when consultations and visits since payment for these services is 77301 because they are part of the were excluded. When consultations and bundled into the RO episode payment. valuation of 77301). The RO Model is visits were included for an analysis of Thus, we proposed to codify at not intended to change Medicare policy technical RT services during 2014–2016, § 512.270 that these RT services would on coverage. 78 percent of episodes involved billing not be paid separately during an Comment: A few commenters by a single entity (TIN or CCN) as episode. In the proposed rule, we recommended excluding proton beam opposed to 94 percent of episodes when indicated that we may add, remove, or therapy (PBT) as a low-volume service. consultations and visits were excluded. revise any of the bundled HCPCS codes A couple commenters suggested The difference in percentages is due to included in the RO Model. We proposed specifically excluding neutron beam the fact that patients see a wide variety to notify participants of any changes to therapy, hyperthermia, and of doctors during the course of cancer the HCPCS codes per the CMS annual brachytherapy radioactive elements as treatment, which will often involve Level 2 HCPCS code file. We proposed low-volume services. visits and consultations. to maintain a list of the HCPCS codes Some commenters requested In the proposed rule we noted that we included in the RO Model on the RO clarification on how ‘‘low-volume’’ and were not proposing to include E/M Model website. ‘‘commonly used’’ will be defined in the services as part of the episode payment. We solicited public comment on our Model. A couple of commenters RO participants would continue to bill proposal. The following is a summary of suggested that the test for low-volume E/M services under Medicare FFS. the public comments received on this services should be conducted on a total Given that physicians sometimes proposal and our responses: and per cancer type basis. contract with others to supply and Comment: A commenter Response: We used ‘‘low-volume’’ administer brachytherapy radioactive recommended that CMS exclude and ‘‘commonly used’’ in several sources (or radioisotopes), we explained consultation services from the Model, as different places in the proposed rule. in the proposed rule that we considered these services are often provided to We proposed to exclude certain RT omitting these services from the episode patients seeking second opinions. If services as low volume, including payment. After considering either CMS includes consultation services, this certain brachytherapy surgical including or excluding brachytherapy commenter suggested classifying these procedures, neutron beam therapy, radioelements from the RO Model, we services as incomplete episodes when hyperthermia treatment, and proposed to include brachytherapy the patient does not pursue treatment radiopharmaceuticals. All of these RT radioactive elements, rather than omit post-consultation. services are rarely furnished to these services, from the episodes Response: Consultations, which are Medicare beneficiaries. In contrast, we because they are generally furnished in billed as E/M services, were not proposed to include the ‘‘most HOPDs and the hospitals are usually the included in the RO Model’s proposed commonly used’’ RT modalities, purchasers of the brachytherapy pricing methodology and are not RT including PBT, in the RO Model as they radioactive elements. When not services, and they are not included in represent standard approaches to furnished in HOPDs, these services are the final rule. treatments that are cited in guidelines furnished in ASCs, which we noted Comment: A couple of commenters for the included cancer types. While we were proposed to be excluded from the expressed support for the exclusion of did not propose a definition for a Model. E/M services from the Model. commonly used RT modality or RT We also proposed to exclude low Response: We thank these service, we used those terms to describe volume RT services from the RO Model. commenters for their support. what is standard practice for radiation These include certain brachytherapy Comment: A few commenters oncology and the included cancer types. surgical procedures, neutron beam expressed concern over the bundling of Though we appreciate the suggestion to therapy, hyperthermia treatment, and IMRT planning code 77301 in that it no look at low-volume RT services on a per radiopharmaceuticals. We proposed to longer allows payment for advanced cancer type basis, as described in the exclude these services from the Model imaging used in data sets for dose proposed rule, we plan to test the because they are not offered in sufficient planning and simulations when charged impact of the RO Model on RT as a amounts for purposes of evaluation. with IMRT treatments. The commenter whole, rather than specific RT services We proposed that the RO Model believed this was inappropriate as it for specific cancer types. Further, we payments would replace current FFS places a burden on providers and believe that including certain RT payments only for the included RT suppliers that cannot afford to upgrade services for some cancer types but not services furnished during an episode. their CT, MR or PET equipment used in others would be burdensome for RO For the included modalities, discussed planning. The commenters expressed participants, specifically regarding the in section III.C.5.d of the proposed rule concern that these costs are not reflected tracking and management of which (84 FR 34502 through 34503), we appropriately in the national base rates. beneficiaries are in or out of the Model. proposed that the RO Model episode Response: The episode payment We note that we are finalizing a low include HCPCS codes related to amounts reflect payments made under volume opt-out option for RO radiation oncology treatment. Please see the PFS and OPPS for RT services participants with fewer than 20 section III.C.7 for a discussion of our furnished during the baseline period. As episodes in one or more of the CBSAs billing guidelines. We have compiled a such, when determining payment rates, randomly selected for participation in list of HCPCS codes that represent we look at RT services in the baseline the most recent calendar year with treatment planning, technical period that were allowed by Medicare available claims data, as described in

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section III.C.3.c. Any PBT providers and in the RO Model will lead to a loss of challenges associated with SGRT suppliers who believe they qualify for direct financial accountability for services into the Model. Another such an exemption should refer to this providing adequate technical commenter stated that CMS has not section. supervision that is provided to each established PFS payment for the G6017 Comment: A couple of commenters patient and could significantly reduce code, which has been in existence since requested clarification on the Model’s medical physics resources around the 2015, and recommended CMS pay for treatment of radiopharmaceuticals. country. A commenter stated that SGRT separately from the Model. These commenters emphasized that, in medical physicists would move to an Response: Although CPT® code 77387 the case of Radium, treatment often area not participating in the Model in was active in the PFS or OPPS in some occurs monthly for six months, far order to maintain their salary. year prior to the updated baseline longer than the 90-day episode. Many Response: It is our understanding that period with spillover (2015–2019), it is commenters requested the removal of medical physics is a state licensure not paid separately. As proposed, the C2616 for Yttrium 90 or Y90 as it is a requirement and is an integral to the Model was only to include codes paid radiopharmaceutical. delivery of RT services. We do not separately. This code was mistakenly Response: We thank these anticipate that the Model will have a included on the list of include RT commenters for this point. As indicated detrimental impact on medical physics services but not in the pricing in the NPRM, radiopharmaceuticals are resources, as participants would methodology. We would also like to excluded from the RO Model, thus continue to need these health care clarify that the code G6017 is C2616 has been removed from the list of providers for many functions, including contractor-priced under the PFS. This RO Model Bundled HCPCS. output calibrations and, where means that CMS has not established Comment: Many commenters clinically appropriate, hypo nationally applicable RVUs for the recommended that CMS exclude the fractionation. As discussed in section service. Instead, individual Medicare radioactive sources from the Model. III.C.14 and III.C.16 of this final rule, we Administrative Contractors (MACs) These commenters emphasized that will monitor for unintended determine the payment rate for the individual patients often require unique consequences of the RO Model. service and apply that rate in their brachytherapy sources, expressing Comment: A commenter has jurisdiction(s). Payment rates across concern that the Model would not requested that any changes made to the MAC jurisdictions can vary. Due to the appropriately compensate for HCPCS code bundles be made through potential differences across differences in isotopes and radioactive notice and comment rulemaking rather jurisdictions, we calculated the average intensity. A few believed that the Model than through a list on the RO Model paid amounts for each year in the would undermine access to the optimal website. baseline period for contractor-priced RT isotope. A commenter believed that Response: We believe that our services to determine their average paid brachytherapy sources were more proposal allows us to update the list in amount to be included in the appropriately considered medical an expeditious manner if we detect an calculation of the national base rates. devices rather than RT procedures. error to facilitate prompt and accurate We will use the most recent calendar Some of these commenters payments. Thus, we are finalizing our year with claims data available to recommended that CMS exclude policies as proposed, without determine the average paid amounts for specific brachytherapy sources, modification, to add, remove, or revise these contractor-priced RT services that primarily the HCPCS A-codes, C-codes, any of the bundled HCPCS codes will be included in the calculation of and Q-codes from the Model. Many included in the RO Model; notify the trend factors for the PC and TC of commenters emphasized that participants of any changes to the each cancer type. For instance, for the brachytherapy sources alone are HCPCS codes per the CMS annual Level 2021 trend factor, we will calculate the frequently more expensive than the 2 HCPCS code file or quarterly update; average paid amounts for these proposed bundled payments— and maintain a list of the HCPCS codes contractor-priced RT services using particularly for high dose rate included in the RO Model on the RO their allowed charges listed on the 2019 brachytherapy—in the proposed Model Model website. If CMS intends to add claims. and that hospitals have little control any new HCPCS codes to the RO Model, Comment: A commenter stated that over these costs. A couple commenters we would go through rulemaking to add inserting a hydrogel spacer between the recommended excluding high dose rate those new codes to the list of RO Model prostate and rectum has become a brachytherapy from the Model. Bundled HCPCS. standard of care at many practices to Response: We thank the commenters Comment: Several commenters reduce the toxicity of radiotherapy, by for their suggestion. We package many expressed concern that the proposed decreasing rectal dose exposure. Many expensive and more expensive services payment methodology was insufficient practices have also implanted fiducial in value-based bundled payment; there for codes 77387 and G6017, as these markers into the prostate to improve the is no reason to treat brachytherapy commenters believed that there is not accuracy of targeting. These items, sources any differently than other currently sufficient payment under the particularly the hydrogel spacer, have a necessary items and services such as PFS for these codes for surface guided significant cost and added physician linear accelerators. We believe that once radiation therapy (SGRT). These work component. The commenter the national base rates are adjusted for commenters believed that by including suggested that payment include a the RO participant’s case mix and these two codes as RT services in the provision to account for this added historical experience, they will see that RO Model, payment under the Model labor and cost. final payments will be reflective of the would not accurately reflect the cost of Response: We believe the commenter inclusion of radioelements. As all care in an episode. Specifically, a is referring to HCPCS 55784. This is not discussed in section III.C.14 and III.C.16 commenter noted that CMS has not an included RT service. Thus, the RO of this final rule, we will monitor for assigned a relative value unit (RVU) for participant may continue to receive FFS unintended consequences of the RO HCPCS 77387 or G6017 in the PFS. The payment upon furnishing this service. Model. commenter believed that inclusion of Comment: Many commenters Comment: Several commenters stated these two codes as RT services in the expressed concern about the lack of that including medical physics services RO Model would extend the payment consideration for emerging or new

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technologies in the Model, and that the attention to the need to reimburse that refer to either brachytherapy pricing methodology of the RO Model HCPCS codes bundled in the RO Model services commonly provided in a generally does not provide an incentive that come to be used differently than surgical setting or that refer to for participants to invest in new historical patterns indicate, whether in brachytherapy sources. These technologies and equipment. A frequency or in combination with other commenters emphasized that surgical commenter explained that the incentive modalities, and this in itself was a new codes for other modalities were is removed, because 2D, 3D, IMRT, and form of technology. excluded from the Model and HDR treatment courses will be billed at One commenter recommended adding questioned why surgical codes 57155, the same rate, and the latest IGRT a payment adjustment for new 57156, 55920, and 53846 were included technologies will not be pursued. technology in the same way OCM has a for brachytherapy. These commenters Another commenter noted that the RO novel therapies adjustment. Another emphasized that the surgical procedures Model does not include any approach to commenter suggested that CMS consider often involve sub-specialized recognize new technology such as the modalities with the 510(k) clearances as physicians, equipment, and other costs. MRI–LINAC. innovations that should be paid By including the surgical component in separately outside of the RO Model. the Model, these commenters worried Commenters defined emerging and A few commenters requested that it would undermine patient access new technologies differently. A clarification as to whether new to care. As relatively low-volume commenter suggested defining new technologies would be paid FFS. A services, these commenters believe technology as any service that has been couple of commenters requested excluding them from the Model would granted a new technology APC or pass- clarification concerning CPT® and through payment. Another commenter HCPCS codes established after the not have a large impact on savings. A suggested that devices be granted an publication of the Final Rule few commenters requested clarification innovative designation if a new specifically, and if those code would be on the inclusion of brachytherapy technology and as a result qualify for paid FFS. insertion codes. additional reimbursement. This Response: To the extent that new Response: We have confirmed with commenter suggested that the technologies and new equipment are clinical experts that these services are innovative designation would need billed under new HCPCS codes, we commonly furnished by radiation approval by the FDA under a Premarket would go through rulemaking to add oncologists and thus will be included in Approval Process and not be those new codes to the list of RO Model the RO Model. We have not included ‘‘substantially equivalent’’ to an existing Bundled HCPCS list. We believe that brachytherapy surgical codes that are device. Another commenter suggested any increased utilization of established only provided by other types of that new technology could be signaled codes that are included RT services over physicians. through a CPT® code transitions from a time will be accounted for with the Comment: A few commenters agreed Category III code to a Category I code. trend factor described in section with the inclusion of RT services as This commenter also suggested that new III.C.6.d. Until new technologies with proposed. technology could include the use of corresponding HCPCS codes are added existing CPT®/HCPCS codes used in the list of included services for the RO Response: We thank these different combination or in more Model, they will be paid FFS. commenters for their support. See Table fractions than what has historically been Comment: Many commenters 2 for the finalized list of included RT used. A few commenters called recommended excluding HCPCS codes services.

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After considering public comments, determine whether the RO Model is able PBT in FFS Medicare grew rapidly,36 we are modifying our proposed list of to impact RT holistically rather than driven by a sharp increase in the included RT services to the testing a limited subset of services. number of proton beam centers and corresponding HCPCS codes in Table 2 As discussed in the proposed rule, Medicare’s relatively broad coverage of of this final rule. We are not adding any because the OPPS and PFS are resource- this treatment. While we cannot assess HCPCS codes to those identified in the based payment systems, higher payment through claims data what caused this proposed rule, but are removing HCPCS rates are typically assigned to services increase in PBT, we can monitor codes 77387, 77424, 77425, C1715, changes in the utilization of treatment C1728, C2616, and 77469 from the that use more expensive equipment. Additionally, newer treatments have modalities during the course of the Model. We are codifying at § 512.235 Model. The previously stated increase that only the following RT services traditionally been assigned higher payment. Researchers have indicated in PBT volume may depend on a variety furnished using an included modality of factors. identified at § 512.240 for an included that resource-based payments may cancer type are included RT services encourage health care providers to As stated in the proposed rule, the RO that are paid for by CMS under purchase higher priced equipment and Model’s episode payment was designed, § 512.265: (1) Treatment planning; (2) furnish higher-cost services, if they have in part, to give RT providers and RT technical preparation and special a sufficient volume of patients to cover suppliers greater predictability in services; (3) treatment delivery; and, (4) their fixed costs.33 Higher payment rates payment and greater opportunity to treatment management; and at § 512.270 for services involving certain treatment clinically manage the episode, rather that these RT services would not be paid modalities may encourage use of those than being driven by FFS payment separately during an episode. All other modalities over others.34 incentives. The design of the payment RT services furnished by an RO In the proposed rule, we explained model grouped together different participant during the Model that Medicare expenditures for RT have modalities for specific cancer types, performance period will be subject to increased substantially. From 2000 to often with variable costs, into a single Medicare FFS payment rules. 2010, for example, the volume of payment that reflects average treatment costs. As explained in the proposed d. Included Modalities physician billing for radiation treatment increased 8.2 percent, while Medicare rule, the Model would include a We proposed at 84 FR 34502 through historical experience adjustment, which 34503 to include the following RT Part B spending on RT increased 216 percent.35 Most of the increase in the would account for an RO participant’s modalities in the Model: Various types historical care patterns, including an RO 2000 to 2010 time period was due to the of external beam RT, including 3- participant’s historical use of more adoption and uptake of IMRT. From dimensional conformal radiotherapy expensive modalities, and certain 2010 to 2016, spending and volume for (3DCRT), intensity-modulated factors that are beyond a health care radiotherapy (IMRT), stereotactic provider’s control. We stated in the 33 radiosurgery (SRS), stereotactic body Falit, B.P., Chernew, M.E., & Mantz, C.A. proposed rule that we believe that radiotherapy (SBRT), and proton beam (2014). Design and implementation of bundled payment systems for cancer care and RT. applying the same payment for the most therapy (PBT); intraoperative International Journal of Radiation commonly used RT modalities would radiotherapy (IORT); image-guided Oncology• Biology• Physics, 89(5), 950–953. allow physicians to pick the highest- 34 radiation therapy (IGRT); and Ibid. value modalities. brachytherapy. We proposed to include 35 Shen, X., Showalter, T.N., Mishra, M.V., Barth, all of these modalities because they are S., Rao, V., Levin, D., & Parker, L. (2014). Radiation oncology services in the modern era: Evolving 36 Spending in PBT rose from $47 million to $115 the most commonly used to treat the 17 patterns of usage and payments in the office setting million, and the number of treatment sessions for proposed cancer types and including for Medicare patients from 2000 to 2010. Journal of PBT rose from 47,420 to 108,960, during that these modalities would allow us to Oncology Practice, 10(4), e201–e207. period.

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We stated in the proposed rule that include RO beneficiaries participating effects, fewer hospitalizations, and given the goals of the RO Model as well in federally-funded, multi-institution, better quality of life. as the payment design, we believe that randomized control clinical trials for Some commenters emphasized that, it is important to treat all modalities PBT. The following is a summary of the while PBT is more expensive up-front, equally. public comments received on these it has significant long-term benefits and With respect to PBT, we noted in the proposals and our responses: savings that may not be captured within proposed rule that there has been debate Comment: Some commenters the 90-day episode. A couple of regarding the benefits of proton beam recommended including PBT in the commenters emphasized that PBT relative to other, less expensive final rule. A couple of commenters improves outcomes and reduces the modalities. The Institute for Clinical believed that including PBT in the total cost of care over 12 months. These and Economic Review (ICER) evaluated episode payment would create an commenters pointed to savings from the evidence of the overall net health incentive to use lower-cost, comparable lower health care consumption to treat benefit (which takes into account modalities. A commenter believed side effects and lower rates of secondary clinical effectiveness and potential including PBT would allow the Model malignancies due to more precise harms) of proton beam therapy in to test whether financial incentives are radiation delivery. A couple of comparison with its major treatment driving clinical decision-making. commenters emphasized that PBT’s alternatives for various types of Another commenter believed the precision makes it the safest way to cancer.37 ICER concluded that PBT has historical experience adjustment would hypofractionate treatment to sensitive superior net health benefit for ocular compensate RO participants who use parts of the body. A commenter tumors and incremental net health more expensive modalities. A couple of emphasized that PBT is frequently used benefit for adult brain and spinal tumors commenters believed that the evidence to hypofractionate regimens when and pediatric cancers. ICER judged that supporting PBT in certain common proven to be effective, using prostate proton beam therapy is comparable with types of cancer, such as prostate and cancer as an example. alternative treatments for prostate, lung, lung, is questionable. Response: We appreciate the commenters’ concerns. The most recent and liver cancer, although the strength Response: We thank the commenters ICER report focuses primarily on a of evidence was low for these for their support and note that we are pediatric population, whose outcomes conditions. In a June 2018 report to finalizing as proposed the inclusion of may not be comparable to the Medicare Congress, MedPAC discussed Medicare PBT in the RO Model with the population. The 2018 MedPAC report coverage policy and use of low-value exception of when PBT is furnished to emphasized that the use of PBT has care and examined services, including an RO beneficiary participating in a expanded in recent years from pediatric PBT, which lack evidence of federally-funded, multi-institution, and rare adult cancers to include more comparative clinical effectiveness and randomized control clinical trial for common types of cancer, such as are therefore potentially low value.38 PBT so that further clinical evidence prostate and lung cancer, despite a lack They concluded that there are many assessing its health benefit comparable of evidence that PBT offers a clinical policy tools, including new payment to other modalities can be gathered. See advantage over alternative treatments models, that CMS could consider § 512.240 for the finalized list of for these types of cancers. The 2019 adopting to reduce the use of low-value included modalities. Washington State Health Care Authority services. Given the continued debate Comment: Many commenters believed PBT re-review examined the around the benefits of PBT, and that PBT is of high value and an comparative effectiveness of PBT over understanding that the PBT is more effective, evidence-based treatment for other forms of RT. For adult tumors, the costly, we discussed in the proposed many clinical indications. Some report stated that the evidence was rule that we believe that it would be commenters suggested that CMS should insufficient to evaluate the comparative appropriate to include in the RO not use questions about PBT’s clinical effectiveness of PBT for bladder, bone, Model’s test, which is designed to value or high, upfront investment as the and pancreatic cancers; unclear for evaluate, in part, site neutral payments basis for inclusion in the RO Model. brain, spinal, and breast cancers; and for RT services. We solicited public Some of these commenters believed that comparable for head and neck, lung, comment on our proposal to include PBT was distinct from other forms of RT and prostate cancers. The report did PBT in the RO Model. and should not be treated as equivalent find that PBT may pose a benefit for As discussed in the proposed rule, we to other modalities by the Model. A liver and certain ocular cancers under considered excluding PBT from the couple of commenters also specific conditions, but concluded that included modalities in instances where recommended exemptions for high-cost the strength of evidence for these an RO beneficiary is participating in a services like PBT when its use is benefits was low. As such, we are federally-funded, multi-institution, supported by evidence. including PBT in the RO Model with the randomized control clinical trial for Some of these commenters believed clinical trial exception, which we PBT so that further clinical evidence that the 2014 reports from the Institute believe provides sufficient opportunity assessing its health benefit comparable for Clinical and Economic Review for more conclusive evidence to be to other modalities can be gathered. We (ICER) and Medicare Patient Advisory generated around PBT in the Medicare also solicited public comment on Commission (MedPAC), which population. We believe that continuing whether or not the RO Model should suggested PBT was of lower value than to gather such evidence in the excepted other modalities, were outdated. A few clinical trials will allow CMS to better 37 Ollendorf, D.A., J.A. Colby, and S.D. Pearson. commenters specified that PBT is address the commenters’ beliefs about 2014. Proton beam therapy. Report prepared by the Institute for Clinical and Economic Review for the indicated for numerous forms of cancer, PBT’s long term benefits. We will Health Technology Assessment Program, and can be particularly useful for continue to review new evidence Washington State Health Care Authority. Olympia, patients who undergo re-irradiation. generated about PBT’s effectiveness in WA: Washington State Health Care Authority. Many these commenters stressed that the Medicare population as it becomes https://icer-review.org/wp-content/uploads/2014/ 07/pbt_final_report_040114.pdf. patients often have better experiences available. 38 http://medpac.gov/docs/default-source/reports/ with PBT than other forms of radiation, Comment: Many commenters jun18_ch10_medpacreport_sec.pdf. with improved survival, fewer side recommended that CMS exclude PBT

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from the RO Model. Many commenters closures would force patients to travel term cost savings. A commenter emphasized that the reimbursement for significant distances to access PBT or recommended excluding PBT to allow PBT under the Model would be too low. forgo treatment. the industry to further demonstrate the These commenters emphasized the high Many commenters believed that the value of PBT. A few commenters operational cost of PBT, which bundled price would reduce patient emphasized that the cost of PBT has commenters generally believed would access to PBT. Some believed patient fallen over the years and believed that not be covered by the current Model’s access would be reduced if PBT it would continue to fall if excluded proposed approach to setting episode facilities closed due to financial from this rule. payments. These commenters indicated hardship caused by the RO Model. Response: We rely on Medicare that the Model would Other commenters suggested that providers and suppliers to furnish disproportionately reduce patient access would be reduced by appropriate care to our beneficiaries. We reimbursement for PBT as compared to providers and suppliers prescribing believe that the clinical trial exception other modalities. Some commenters alternative modalities when PBT would will continue to enable providers and believed that the RO Model would be more appropriate. A couple suppliers to generate evidence about result in a nearly 50 percent reduction commenters suggested that providers PBT, allowing innovation in this field to in payment for PBT, while and suppliers might refer patients to continue. Further, our approach to the reimbursement across all other PBT facilities in CBSAs selected for calculation of participant-specific modalities would decrease by 4 percent. comparison. A commenter expressed episode payment amounts places great A few commenters believed that low that patients should have access to the weight on an individual entity’s reimbursement under the Model would treatment modality that affords them a historical experience. This approach further reduce PBT payments outside of chance to achieve the best possible accounts for an entity’s high cost the Model, as commercial insurers and outcome. Other commenters generally relative to the national average and Medicaid programs would follow suit. emphasized the value of PBT in includes a glide path over time. Some commenters believed that the delivering lower and more precise Furthermore, as described in section national base rate did not include a radiation doses. These commenters III.C.6.b, to address the concerns meaningful volume of proton therapy voiced their concern that, in regarding the Model’s national base rate, episodes, leading to payment rates that incentivizing RO participants to utilize the base rates that were calculated for do not reflect the costs of providing modalities other than PBT, patients purposes of this final rule were shifted PBT. A couple of these commenters would be exposed to more radiation and forward to 2016–2018, capturing more emphasized that restricting the national a greater risk of additional, costly recent data from a greater number of base rate-setting methodology to only cancers in the future. A couple of PBT centers compared with the data HOPD episodes excludes about 65 commenters stated that other countries used in the proposed rule. As described percent of PBT episodes. A commenter will have greater access to PBT than the in section III.C.6.c, we believe that the recommended that CMS reconsider the U.S. by 2024. These commenters use of HOPD episodes for calculating establishment of the national base rate generally believed that excluding PBT the national base rates provides a based only on HOPD episodes due to its from the Model and continuing to stronger empirical foundation. Blending detrimental impact on proton beam reimburse it as FFS would prevent these together the national base rates, which therapy centers. Another commenter reductions in patient access. are derived from HOPD episodes, with emphasized that PBT services do not Some commenters believed that the the RO participant’s own historical follow the pattern for other RT services impact of any PBT center closures experience (whether HOPD or in HOPD and freestanding facilities: would have an impact beyond the freestanding radiation therapy center) Freestanding RT centers are paid less Medicare population. These will allow the RO participant’s unique than their HOPD counterparts and PBT commenters generally referenced the care patterns to be recognized in the has a higher ratio of freestanding to value of PBT to certain pediatric participant-specific episode payment HOPD providers than other modalities. cancers, as well as head and neck amounts. This commenter also highlighted that a cancer, brain tumors, and thoracic We do not believe that the RO Model, significant number of PBT centers have lymphoma, and feared that PBT center which as finalized will be tested in opened since 2015, meaning that the closures would jeopardize access for approximately 30 percent of episodes CMS data on which the base rates are these patient groups. A couple of nationally and which will include a founded does not represent the current commenters believed the Model will gradual shift in payments toward the state of PBT. deepen cancer disparities by targeting national average, will affect access to Many commenters believed the freestanding radiation therapy centers. PBT. We plan to carefully monitor the bundled price would either reduce One such commenter believed that if the RO Model for unintended consequences investment in PBT therapies or cause Model forced freestanding PBT facilities as finalized in section III.C.14 and existing PBT facilities to close. A couple to close, the impact would III.C.16. If our monitoring reveals that of commenters stated their belief that disproportionately impact low-income the Model reduces patient access to many PBT facilities operate on thin and minority groups. A commenter PBT, we would consider making margins and believed the Model would emphasized that the IPPS and OPPS changes to the Model via future place them in tenuous financial provide stratifications of cost to avoid rulemaking. Further, our evaluation will positions. A commenter emphasized similar reductions in access to consider longer-term impacts on health that such closures would result in the technology. outcomes associated with the Model. loss of jobs. A few of commenters Some commenters expressed concern Comment: If included in the Model, emphasized the uneven geographic that including PBT in the Model would many commenters had suggestions for distribution of existing PBT facilities— reduce the ability of providers and how to structure PBT payments. A a commenter stated that only 35 percent suppliers to generate evidence about couple of these commenters of the U.S. population has access to PBT PBT and stifle innovation in this field. recommended creating a separate today, and believed that this percentage A couple such commenters emphasized bundled price for PBT that is a would shrink under the Model. These that slowing innovation could deprive percentage of the current medically commenters suggested that PBT center Medicare of potentially significant long- accepted case rate instead of the

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proposed APM bundled prices. A in the Model and the national base rates section III.C.16, the evaluation’s focus commenter suggested that CMS consider will be publicly available; new PBT will be on the impact of the Model as a step wise reduction in payments, facilities in a selected geographic area a whole rather than on comparing the which would account for the fact that will have their episode payment impact of the Model on individual adoption of this technology is still in the amounts adjusted for case mix once data modalities, though subanalyses will be nascent stages. A couple other are available. We are finalizing the conducted where feasible. commenters recommended creating a inclusion of PBT in the RO Model’s Comment: Some commenters separate Model for PBT. A few pricing methodology (see section III.C.6) supported the proposed exclusion of commenters recommended creating a to maintain our modality agnostic cases where an RO beneficiary is separate base rate for PBT. Another approach. See § 512.240 for the finalized participating in a federally-funded, commenter suggested that PBT should list of included modalities. multi-institution, randomized control be reconsidered for inclusion at the end Comment: A commenter believed that clinical trial for PBT. These commenters of the five-year pilot phase. Another a randomly selected sample for the RO generally believed that the exclusion, as commenter recommended exempting Model has a high likelihood of not proposed, would permit the generation PBT facilities that have yet to be selecting an adequate number of centers of further clinical evidence comparing constructed. MedPAC expressed that provide PBT. The commenter PBT to other modalities, while allowing support for the inclusion of PBT in the believed this would reduce the ability to the Model to include some beneficiaries RO Model because Medicare’s payment statistically validate the impact of who receive PBT. MedPAC added that rates for PBT are substantially higher proton therapy in the bundle. This if CMS decides to exclude PBT from the than for other types of external beam commenter further believed that the Model when it is part of a research radiation therapy. In addition, MedPAC geographic dispersion of centers means study, CMS should only do so if the noted that the use of PBT has expanded that only a few centers could contribute study is a federally-funded, multi- in recent years from pediatric and rare the majority of episodes, leading to institution, randomized control trial. adult cancers to include more common results inconsistent with the industry. This requirement would help ensure types of cancer, such as prostate and Response: As discussed in section that studies of PBT produce robust lung cancer, despite a lack of evidence III.C.16, the evaluation’s focus will be information on how it compares with that it offers a clinical advantage over on the impact of the Model as a whole other modalities. In addition, limiting alternative treatments for these types of rather than on comparing the impact of this exclusion would allow the Model to cancer. Therefore, including PBT in the the Model on individual modalities, include at least some beneficiaries who episode payment would create an though subanalyses will be conducted receive PBT. incentive to use lower-cost, comparable where feasible. Many commenters recommended that Comment: Many commenters CMS expand the proposed exclusion of modalities. recommended that CMS exclude PBT as cases where an RO beneficiary is Response: We thank the commenters a low-volume modality. These participating in a federally-funded, for their feedback. We believe that our commenters generally believed that PBT multi-institution, randomized control approach to blending the national base is not commonly used and that there is trial. These commenters generally rates with the RO participant’s historical insufficient data supporting its believed that the proposed exclusion experience, with the blend shifting more inclusion in the Model. Some might restrict opportunities that would to the national base rates over time for commenters emphasized that PBT only benefit Medicare FFS beneficiaries. those with historical payments above accounted for 0.7 percent of all episodes One commenter believed that CMS the national base rates, provides a in 2017, while others specified that PBT should expand the proposed exclusion stepwise reduction in payment over the episodes would represent more than 1 of cases because no existing clinical Model, regardless of modality. We do percent of total episodes for only six of trials would meet the proposed criteria. not believe a separate model for PBT is the 17 cancer types and less than 0.5 Some commenters suggested that CMS necessary because we have created an percent of the episodes for the use Medicare evidence development exemption where PBT is not an remaining 11. A commenter expressed precedent—via a registry structured in included modality when furnished to an concern that including a low-volume compliance with CMS or AHRQ RO beneficiary participating in a service like PBT would decrease the guidance or a clinical trial registered on federally-funded, multi-institution, rigor of any evaluation, rendering clinicaltrials.gov—to structure this randomized control clinical trial for results unreliable or misleading. A exemption. A commenter emphasized PBT so that further clinical evidence commenter suggested both limiting low- that this approach would be consistent assessing its health benefit comparable volume modalities like PBT to a smaller with existing Local Coverage Decisions to other modalities can be gathered. If percentage of episodes and making for some proton beam therapy providers we were to exclude all PBT from the RO participation voluntary. and suppliers. Other commenters Model or to create a separate base rate, Response: We appreciate these suggested that RT providers or RT it would undermine the RO Model test, commenters’ suggestions. Per many suppliers with a history of evidence which is testing an episode-based commenters as well as claims data, PBT development should be exempt from the payment that does not vary based on is one of the standard approaches to Model. where the services are provided or how providing radiotherapy for the included Some commenters, emphasizing the many or which type of RT services are cancer types, and as such, it is extensive evidence generated by recent provided during the episode. Further, appropriate and important to include PBT studies, recommended expanding doing either of these recommended PBT as a modality in the Model. the exclusion to cover all clinical trials, approaches could create an incentive for Although PBT is currently used less regardless of whether such trials are RO participants to provide PBT as a way frequently than the other included federally funded or randomized to avoid being in the Model. In addition, modalities, we believe that its exclusion controlled trials. A couple of we do not believe that an exemption is would undermine our ability to test commenters emphasized that necessary for PBT facilities that have whether the Model incentivizes the use randomized clinical trials are not yet been constructed since the of high-value, appropriate care for RO challenging and not always practical in geographic areas selected to participate beneficiaries. Notably, as discussed in radiation oncology. These commenters

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also believed that registry data could of PBT to other RT modalities. We agree brachytherapy ‘‘boost’’ when generate clinical evidence. Other that these registry trials are unlikely to accompanying other modalities is an commenters believed that much ongoing generate the type of evidence needed to important, clinical guideline-driven research takes place in academic change the standard of care. We also treatment for certain patients. These institutions without federal funding. note that data collected through registry multimodality cases are particularly These commenters generally believed trials is often not analyzed or published. common for treating cervical cancer, that a broadened exemption would We believe that the inclusion of breast cancer, and prostate cancer, and incentivize the collection of additional federally-funded, multi-institution, they require more work than cases clinical data to determine PBT’s clinical randomized control clinical trial for involving a single modality, as each value, particularly in comparison to PBT is important to include so that modality requires unique treatment other modalities such as IMRT and further clinical evidence assessing its planning and delivery services. A brachytherapy. health benefit comparable to other commenter emphasized that patients are An additional commenter suggested modalities can be gathered. There are often sent to regional hub facilities for excluding beneficiaries who are established procedures that exist in the these boosts, reducing unnecessary enrolled in an IRB-approved clinical Medicare claims systems for identifying duplication of expensive equipment and trial. A commenter recommended using and paying for services furnished during staff. A couple of these commenters this regulation to address the scope and participation in clinical trials. A recent expressed concern that should the caliber needed for a clinical trial to study concluded that prospective trials Model not provide adequate become exempt. are warranted to validate studies related compensation for multiple modalities A couple of commenters to the use of proton and photon beam furnished within a single episode, recommended that the proposed clinical therapies.39 particularly those involving trial exclusion not be modified. A Comment: Some commenters brachytherapy, providers and suppliers commenter recommended that the supported the inclusion of might be incentivized to delay treatment exclusion only cover participants in brachytherapy in the Model, while or to depart from clinical guidelines. randomized clinical trials, suggesting many comments opposed its inclusion. These commenters emphasized that that the payment could be readjusted if For those that supported the inclusion these perverse incentives could reduce these studies demonstrate a defined of brachytherapy, they argued that its patient access to medically necessary clinical benefit. inclusion in the Model along with the care. Moreover, a couple of commenters A couple of commenters suggested other modalities would incentivize the believed that there were problems with that CMS decline to expand this provision of the most efficacious and the underlying data and pricing exemption to include registry trials. A cost-effective treatments and improve methodology. A commenter believed commenter emphasized that in sites access to brachytherapy as a treatment that errors in the claims data stemming such as breast, head and neck, option. A couple of commenters from incorrect attribution of CPT®/ esophagus, and prostate cancer, a opposed brachytherapy’s inclusion in HCPCS codes to certain modalities registry trial adds only a single arm or the Model, worrying the Model might underrepresented the true cost of retrospective data that does little to disincentivize its use, particularly delivering a combination of modalities compare proton to photon therapy in among vulnerable cancer populations, like EBRT and brachytherapy. these sites. Another commenter believed such as women with cervical cancer. A A few commenters emphasized that that an exemption for registry trials couple of commenters recommended brachytherapy services are often would lead every patient at every proton excluding brachytherapy on the premise provided by physicians other than center to be put on a registry trial, that it is a low-volume modality. radiation oncologists, such as adding only to an existing body of Many commenters expressed gynecological oncologists, urologists, literature on single arm series of proton concerns with the inclusion of interventional radiologists, and surgical therapy. This commenter did not brachytherapy as proposed. Some of oncologists, and that these physicians believe registry trials add sufficient these commenters emphasized could operate under the same or evidence to change the standard of care. brachytherapy’s unique nature as it is a different RT provider or RT supplier One commenter emphasized that standalone treatment and is also used in when brachytherapy is provided in proton therapy for primary treatment of combination with external beam conjunction with another modality. prostate cancer should be performed radiotherapy (EBRT). These commenters Some commenters expressed concern within the context of a prospective were concerned that the RO Model that the current RO Model does not clinical trial or registry. would not provide adequate payment adequately account for the various A few commenters recommended that for all situations in which combinations of physicians and CMS exempt all care—not just PBT— brachytherapy is indicated, particularly treatment settings in which provided under a clinical trial protocol when a single episode involves multiple brachytherapy is furnished. A few from the Model. A commenter treatment modalities, multiple RT commenters explained that CMS should specifically recommended that CMS providers or RT suppliers, multiple not consider multiple modality cases exclude patients enrolled in clinical disease sites, or multiple treatment delivered by two physicians as trials in which the focus is radiation settings. duplicate RT services, as these oncology treatment or technology, Some commenters focused on cases physicians are working in tandem on a emphasizing that the costs of these cases involving multiple modalities. These treatment plan rather than duplicating are unique and may influence commenters emphasized that the one another’s efforts. adjustment factors or future Model data. A few commenters recommended that Response: We appreciate these 39 Baumann, B.C., Mitra, N., Harton, J.G., Xiao, Y., brachytherapy trigger a second RO comments and suggestions. We agree Wojciezynski, A.P., Gabriel, P.E., Zhong, H., Geng, Model bundle, with a separate PC and with commenters that the use of registry H., Doucette, A., Wei, J., O’Dwyer, P.J., Bekelman, TC payment, when delivered within a trials is insufficient, as the single-arm J.E., & Metz, J.M. (2019). Comparative effectiveness single 90-day episode that also includes of proton vs proton therapy as part of concurrent design of registry trials makes them chemoradiotherapy for locally advanced cancer. EBRT. Some commenters suggested that unlikely to result in published studies JAMA Oncology, doi:https://doi.org/10.1001/ brachytherapy be reimbursed as FFS evaluating the comparative effectiveness jamaoncol.2019.4889. when delivered during an episode

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including EBRT. To implement this consequences of the Model on multi- brachytherapy, SRS, and 1–10 3D EBRT change, a commenter suggested adding modality treatment that includes both occur in clinically unlikely episodes in a modifier to episodes in which both external beam and brachytherapy. the RO Episode File. brachytherapy and EBRT are provided. As for the concern that errors in the Response: We appreciate this This modifier would trigger the second claims data (specifically those that question. We are confirming that SRS bundled or FFS payment and prevent commenters believe stem from incorrect and SBRT are both included in the RO the episode from going to reconciliation. attribution of CPT®/HCPCS codes to Episode File (2015–2017) under the These commenters believed that these certain modalities) underrepresented classification of SRS. We understand the solutions would adequately address the the true cost of delivering a combination difference between and SRS and SBRT various combinations of modalities, RT of modalities like EBRT and but erroneously labeled the column in providers and RT suppliers, and settings brachytherapy, we rely on the data the file as COUNT_SRS without that might arise during brachytherapy submitted on claims by providers and explaining in the Data Dictionary posted treatment. A commenter further suppliers to be accurate per Medicare on the RO Model website that COUNT_ emphasized that this structure would rules and regulations. We are finalizing SRS includes both SRS and SBRT. This alleviate possible negative incentives in the provision to include brachytherapy clerical error did not impact our the Model, ensure that patients continue in the RO Model. calculations of the proposed base rates. to receive high-quality care, and have Comment: A commenter specifically Comment: Some commenters minimal impact on overall CMS requested that the Model include expressed concern that the bundled expenditures. electronic brachytherapy (EB). payment structure might lead providers Response: We thank commenters for Response: EB radiation is generated and suppliers to substitute older, less their support of including and delivered in a markedly different expensive modalities for newer, more brachytherapy as well as those way than traditional brachytherapy, and expensive modalities. One of these commenters expressing their concerns its dosing and clinical implications are commenters emphasized their concern and their suggestions. still being studied. Until EB is more for patient access to the most effective An episode-based payment covers all commonly used, CMS will continue to care from the RT provider or RT included RT services furnished to an RO pay FFS for this RT service. supplier, noting that the clinician is best beneficiary during a 90-day episode. Comment: A few commenters suited to determine appropriate Bundled episode payment rates are suggested excluding more modalities treatment for the patient. Another premised on the notion of averages. The from the Model due to their infrequent commenter emphasized that, while an cases including a combination of EBRT use. A commenter recommended individual RO participant might save and brachytherapy described by the including only the most common costs by selecting the cheapest treatment commenters are part of the set of modalities and excluding during the 90-day episode, longer-term historical episodes included in the brachytherapy, SRS, SBRT, and PBT. A Medicare costs could rise due to later averages that determine the national commenter recommended excluding complications or secondary tumors. A base rates and contribute to how IORT since it is used so rarely. A different commenter stated this Model payment amounts are valued, and, commenter was concerned that the incentivizes the use of the cheapest therefore, an adjustment for multiple proposed payment structure will forms of radiation therapy, which also modalities that include brachytherapy is promote the use of short course, less deliver the greatest amount of radiation not warranted at this time. Also, the costly forms of treatment such as IORT to healthy tissue. case mix and historical experience in cases where traditional external beam Response: We appreciate commenters’ adjustments help account for the radiation would have been preferred. concerns. We rely on Medicare costlier beneficiary populations in the Response: We thank these providers and suppliers to furnish participant-specific episode payment commenters for these suggestions. We appropriate care to our beneficiaries. As amounts. We will be monitoring for agree with the commenter that it would finalized in section III.C.14, we will change in treatment patterns throughout be appropriate to exclude IORT from the monitor for unintended consequences of the Model performance period and will RO Model because it is not a standard the RO Model including but not limited consider modifications to the pricing approach to treatment, and we believe to stinting on care. methodology in future years of the that including IORT may incentivize Comment: A commenter requested Model should it be warranted. misuse of this treatment. See § 512.240 that CMS provide additional We believe that including for the finalized list of included comparative effectiveness data between brachytherapy in the Model supports modalities. included and excluded modalities. This this modality as high value, and also Comment: A commenter requested commenter expressed concern that more that including it preserves the goal of clarity on the codes used to define effective, and potentially more the Model in establishing a true bundled stereotactic radiosurgery and also expensive modalities, were not included approach to radiotherapy that is also expressed concern that the RO Episode because they are not accessible to many site neutral and modality agnostic. And, File (2015–2017) has SRS attributed to Medicare beneficiaries. This commenter we believe that the proposed and episodes that are classified as brain emphasized that racial and gender finalized pricing methodology and metastasis or CNS. SRS as defined in the disparities in cancer outcomes may be subsequent national base rates for each HCPCS should be a single treatment due to disparities in treatment options, cancer type accounts for the cost of delivery and directed at an intracranial and requested that CMS justify how the brachytherapy as a primary modality brain lesion. It is likely that CMS is inclusion of these modalities addresses and if furnished in conjunction with incorrectly including SBRT into the SRS disparities. EBRT. We recognize the billing count, since SRS is typically used for Response: We appreciate this complexity when separate RT providers brain metastases, and SBRT is typically commenter’s concerns. We did not use and RT suppliers furnish the used for early primary lung cancers or comparative effectiveness data to brachytherapy and EBRT and will metastatic disease to various locations determine whether modalities were address this in billing guidance in the body. In addition to included/excluded but rather focused provided to RO participants. We will misattribution of the SRS episodes, this on the most commonly utilized monitor for any unintended commenter stated that episodes of approaches to radiotherapy for the

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included cancer types. We believe that blend in PY5. This means that in PY5, term, ‘‘participant-specific technical the RO Model pricing methodology, prior to applying the discount factor and episode payment,’’ at § 512.205 of our through the historical experience and withholds that payments under the regulations. case mix adjustments, will account for model will be more than 70 percent of In the proposed rule, we proposed differences in RO participants’ historical the RO participant’s historical eight primary steps to the pricing care patterns and the demographic payments. We believe that the pricing methodology (84 FR 34503 through characteristics of their patient methodology tested under the Model 34504). In the first step, we proposed to populations. We rely on Medicare represents an opportunity to provide create a set of national base rates for the providers and suppliers to furnish high-value episode-based payments to PC and TC of the included cancer types, appropriate care to our beneficiaries. RO participants for Medicare FFS yielding 34 different national base rates. This includes prescribing the most beneficiaries; other payors determine Each of the national base rates appropriate modality. If a modality is their own payment approaches for RT represents the historical average cost for not included in the RO Model, it will services. an episode of care for each of the continue to be paid FFS. As finalized in Comment: A commenter included cancer types. We proposed section III.C.14 and III.C.16, we will recommended applying savings that the calculation of these rates will be monitor for unintended consequences of proportionately to all modalities, based on Medicare FFS claims paid the RO Model. particularly if CMS has a savings target during the CYs 2015–2017 that are Comment: A couple of commenters under the Patient Access and Medicare included under an episode where the expressed concern about the impact of Protection Act. initial treatment planning service the Model not only on Medicare Response: While the RO Model is occurred during the CYs 2015–2017 as beneficiaries, but also about the projected to be expenditure neutral or described in section III.C.6.b of the continued viability of offering PBT to achieve Medicare savings, we did not proposed rule (84 FR 34504 through patients. These commenters stated that have any specific predefined targets in 34505) and this final rule. If an episode unsustainable payment rates from mind, and we believe our pricing straddles calendar years, the episode Medicare would put centers’ viability at methodology has a graduated approach and its claims are counted in the risk, both operational centers as well as to setting participant-specific payments calendar year for which the initial centers currently under development. that is heavily weighted to the treatment planning service is furnished. They stated that Medicare is a material participant’s historical experience. We proposed to exclude those episodes payor for the majority of members, After considering public comments, that do not meet the criteria described representing the majority of their payor we are finalizing our proposed list of in section III.C.5 of the proposed rule mix, and reducing their payment rates included modalities in the RO Model at and this final rule. From the remaining by up to 50 percent below cost will not § 512.240, with the modifications of episodes (that is, not including the be sustainable. They also stated that removing intraoperative radiotherapy excluded episodes), we proposed to while the RO Model is focused on (IORT) from the list of included then calculate the amount CMS paid on Medicare fee-for-service, it has modalities in the RO Model. average to providers and suppliers for implications for other payors, as many the PC and TC for each of the included private payors often use the Medicare 6. Pricing Methodology cancer types in the HOPD setting, rates as a proxy, which could impact a a. Overview creating the Model’s national base rates. center’s broader payor mix. Further, Unless a broad rebasing is done after a these commenters stated that viability The proposed pricing methodology in later PY in the Model, these national impacts not only Medicare beneficiaries the proposed rule described the data base rates will be fixed throughout the but indirectly affects a broader set of and process used to determine the Model performance period. patients including pediatric cancer amounts for participant-specific In the second step, we proposed to patients who will lose access to a professional episode payments and apply a trend factor to the 34 different treatment that is now the standard of participant-specific technical episode national base rates to update those care. payments for each included cancer type amounts to reflect current trends in Response: We appreciate these (84 FR 34503). In the proposed rule, we payment for RT services and the volume commenters’ concerns. We disagree proposed to define the term of those services outside of the Model with the commenters on the expected ‘‘participant-specific professional under the OPPS and PFS. We proposed magnitude of reduction in RO episode payment’’ as a payment made to define the term ‘‘trend factor’’ to participants’ payments for PBT by CMS to a Professional participant or mean an adjustment applied to the compared to what they currently Dual participant for the provision of the national base rates that updates those receive. As described in section III.C.6, professional component of RT services rates to reflect current trends in the the pricing methodology as finalized furnished to an RO beneficiary during OPPS and PFS rates for RT services. We will blend together the national base an episode, which is calculated as set proposed to codify the term ‘‘trend rate with an RO participant’s unique forth in § 512.255. We further proposed factor’’ at § 512.205 of our regulations. historical experience. If the RO to codify this term, ‘‘participant-specific In this step, we would calculate separate participant is historically more costly professional episode payment,’’ at trend factors for the PC and TC of each than the national average, the blend in § 512.205 of our regulations. cancer type using data from HOPDs and PY1 will be 90 percent of the RO We proposed to define the term freestanding radiation therapy centers participant’s historical payments and 10 ‘‘participant-specific technical episode not participating in the Model. More percent of the national base rate. This payment’’ as a payment made by CMS specifically, as noted in the proposed means that, prior to applying the to a Technical participant or Dual rule, the calculations would update the discount factor and withholds that participant for the provision of the national base rates using the most payments under the Model will be technical component of RT services to recently available claims data of those between 90 and 100 percent of the RO an RO beneficiary during an episode, non-participating providers and participant’s historical payments. For which we proposed to calculate as set suppliers and the volume at which they historically inefficient RO participants, forth in § 512.255 of the proposed rule. billed for RT services as well as their the blend shifts over time to a 70/30 Further, we proposed to codify this corresponding payment rates. Adjusting

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the national base rates with a trend reserve savings for Medicare and reduce beneficiary coinsurance and a 2 percent factor will help ensure payments made beneficiary cost-sharing. We proposed adjustment for sequestration to the under the Model appropriately reflect to codify the term ‘‘discount factor’’ at trended national base rates that have changes in treatment patterns and § 512.205. been adjusted as described in steps payment rates that have occurred under In the fifth step, we proposed to three through six, yielding participant- OPPS and PFS. further adjust payment by applying an specific episode payment amounts for In the third step, we proposed to incorrect payment withhold, and either the provision of the PC and TC of each adjust the 34 now-trended national base a quality withhold or a patient included cancer type in the Model. We rates to account for each Participant’s experience withhold, depending on the proposed to calculate a total of 34 historical experience and case mix type of component the RO participant participant-specific professional and history. The historical experience and furnished under the Model. The technical episode payment amounts for case mix adjustments account for RO incorrect payment withhold would Dual participants, whereas we would participants’ historical care patterns and reserve money for purposes of only calculate 17 participant-specific certain factors that are beyond an RO reconciling duplicate RT services and professional episode payment amounts participant’s control, which vary incomplete episodes during the or 17 participant-specific technical systematically among RO participants so reconciliation process, as discussed in episode payment amounts for as to warrant adjustment in payment. section III.C.11 of the proposed rule and Professional participants and Technical We proposed that there would be one this final rule. We proposed to define participants, since they furnish only the professional and/or one technical case the term ‘‘duplicate RT service’’ to mean PC or TC, respectively. mix adjustment per RO participant any included RT service (as identified at Following this description of the data depending on the type of component the § 512.235 of the proposed rule) that is and process used to determine the RO participant furnished during the furnished to a single RO beneficiary by amounts for participant-specific 2015–2017 period, just as there would a RT provider or RT supplier or both professional episode payments and be one professional and/or one technical that did not initiate the PC or TC of that participant-specific technical episode historical experience adjustment per RO RO beneficiary during the episode. We payments for each included cancer type, participant, depending on the type of proposed to codify ‘‘duplicate RT the proposed rule provided a pricing component the RO Participant furnished service’’ at § 512.205 of the proposed example for an episode of lung cancer during the 2015–2017 period. We rule. We proposed that an incomplete (at 84 FR 34511). We provided this proposed to generate each RO episode means the circumstances in example to show how each pricing participant’s case mix adjustments using which an episode does not occur component (that is, national base rates, an ordinary least squares (OLS) because: (1) A Technical participant or trend factors, case mix and historical regression model that predicts payment a Dual participant does not furnish a experience adjustments, withholds, based on a set of beneficiary technical component to an RO discount factors, geographic adjustment, characteristics found to be strongly beneficiary within 28 days following a beneficiary coinsurance, and correlated to cost. In contrast, we Professional participant or the Dual sequestration) figures into these proposed to generate each RO participant furnishing the initial RT amounts. We also provided a summary- participant’s historical experience treatment planning service to that RO level, de-identified file titled the ‘‘RO adjustments based on Winsorized beneficiary; (2) traditional Medicare Episode File (2015–2017),’’ on the RO payment amounts for episodes stops being the primary payer at any Model’s website to further facilitate attributed to the RO participant during point during the relevant 90-day period understanding of the RO Model’s the calendar years 2015–2017. The for the RO beneficiary; or (3) an RO pricing methodology. The following is a historical experience adjustments for beneficiary stops meeting the summary of the public comments each RO participant would be further beneficiary population criteria under received on this proposal, specifically weighted by an efficiency factor.40 The § 512.215(a) or triggers the beneficiary those comments related not to particular blend measures if an RO participant’s exclusion criteria under § 512.215(b) pricing components, but rather episodes (from the retrospectively before the technical component of an comments related to the Model’s pricing constructed episodes from 2015–2017 episode initiates. methodology in its general approach, claims data) have historically been more We also proposed to adjust for a potential impact, and structure as well or less costly than the national base quality withhold for the professional as information provided to thoroughly rates, and this determines the weight at component of the episode. This review the methodology on these points which each RO participant’s historical withhold would allow the Model to and our response: experience adjustments are applied to include quality measure results as a Comment: Many commenters the trended national base rates. factor when determining payment to requested additional information and In the fourth step, we proposed to participants under the terms of the data be provided in order to ascertain further adjust payment by applying a APM, which is one of the criteria for an the degree of impact that the Model’s discount factor. The discount factor is APM to qualify as an Advanced APM as pricing methodology will have on the set percentage by which CMS specified in 42 CFR 414.1415(b)(1). We participant payment relative to what reduces payment of the PC and TC. The proposed to adjust for a patient participants have historically been paid reduction on payment occurs after the experience withhold for the technical under FFS. Some commenters argued trend factor and adjustments have been component of the episode starting in that additional information is needed in applied, but before standard CMS PY3 to account for patient experience in order to justify the RO Model’s pricing adjustments including the geographic the Model. We would then apply all of and policies in general. Several other practice cost index (GPCI), these adjustments, as appropriate to commenters made requests for sequestration, and beneficiary each RO participant’s trended national information related to specific pricing coinsurance. The discount factor will base rates. components. Several commenters stated In the sixth step, we proposed to that the case mix adjustment is not 40 Please note that in the final rule we are apply geographic adjustments to adequately defined and that more detail renaming the efficiency factor the ‘‘blend,’’ as payments. In the seventh and final is needed concerning the regression discussed in section III.C.6.e(2) of this final rule. eighth step, we proposed to apply models used to construct the case mix

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adjustments. A few commenters available. Also, it is important to note permit two-sided risk that would allow requested additional information that in analyzing 2015–2017 episode providers and suppliers to enter into regarding the historical experience data, we found that participants’ case risk at a self-determined pace. A few adjustments, specifically the number mix is relatively stable over time for commenters suggested that the RO and type of providers and suppliers that most providers and suppliers. Model take a ‘‘shared savings’’ approach are classified as efficient versus We believe that this prospective with RO participants sharing risk for inefficient. episode-based payment structure for RT gains and losses. Another commenter Response: Based on a full review of services is the best design for testing an suggested a graduated glide path to risk comments and the detailed analyses episodic APM for RT services. The for the RO Model, similar to the contained within some of them, we payment rates for RO episodes of care approach adopted in the Medicare believe that commenters have had are unambiguous and known to RO Shared Savings Program (Shared sufficient detail to fully comment on the participants prior to furnishing RT Savings Program) Pathways to Success proposed RO Model. We prioritize, services. We are testing an approach final rule. Another commenter however, these comments and along where prospective episode-based suggested that payment be set by with the finalized parameters of the payments will not be reconciled based optimal actual costs of well-managed Model, provide additional resources to on how many or which individual RT sites of service that furnish radiation include detailed illustrations, examples, services are provided by the RO with a margin to allow for innovation and data, particularly concerning the participant during the RO episode, with and upgrades. A commenter requested case mix and historical experience the exception of incomplete episodes clarification as to whether RO adjustments. We refer readers to and duplicate RT services. This allows participants could reinsure or get stop- sections III.C.6.e.(1) and III.C.6.e.(2) of us to test the impact of episode-based loss insurance to mitigate risk, since RO the case mix and historical adjustments, payments that do not have today’s FFS participants are at risk for all costs over respectively, for that additional detail incentives. the bundled payment amounts. and to section III.C.6.j which closes the Comment: Many commenters Response: We thank these pricing methodology section. Here we expressed concern over the participant- commenters on their feedback and list additional data we are able to specific professional episode payment suggestions related to Model payments provide at request of the commenters. and technical episode payment amounts relative to those received under FFS. We Comment: Many commenters related to what non-participants in the disagree that episode payment amounts expressed support for a prospective Model will receive under FFS. would be reduced by 50 percent as payment model in radiation oncology. A Commenters believed that the proposed compared to non-participants. We few commenters took issue with the pricing methodology as constructed designed the pricing methodology so prospective nature of the Model’s with the national base rates based on that participant-specific professional payment rates, because they were not HOPD claims data alone along with the and technical episode payment amounts adjusted for factors occurring in the proposed adjustments, discounts, and are largely based on what each current performance year. A commenter withholds, RO participants will be participant has been paid historically suggested that the RO Model change to unable to receive sufficient payment under FFS and trended forward based a retrospective payment model in that under the Model or reasonably achieve on latest payment rates under FFS. this would allow for payment rates to be savings. A commenter estimated that RO Moreover, we adjust for those adjusted for the patient population of participants would receive up to 50 beneficiary characteristics that have a the performance period for which percent less in payments under the large impact on cost in the case mix payment was being allotted. A Model than non-participants who adjustment. commenter opposed the Model continue to be compensated under FFS. We note, however, that RO generally, explaining that the RO Model Many commenters stated that the participants that have fewer than 60 is an experiment focusing on short-term proposed pricing methodology does not episodes in the baseline period do not effects and costs, and ignores medium- adequately pay RO participants for labor have sufficient historical volume to and long-term complications and the and resources required to care for the calculate a reliable historical experience resulting cost of care, such as costly side most complex patients and that the adjustment. Since these RO participants effects and secondary malignancies. Model underestimates the costs and will not qualify to receive a historical Response: We thank the commenters administrative burden of adjusting to experience adjustment and may see for sharing their support and concerns and complying with the Model. A few greater increases or reductions as regarding a prospective payment model commenters explained that payment compared to what they were historically in radiation oncology. It is not the intent under the Model would represent paid under FFS as a result of not of the Model for payment based on 90- significant cuts to what RT providers receiving the adjustment, we believe day episodes to incorporate the long- and RT suppliers have been historically that it is appropriate to adopt a stop-loss term health outcomes of a patient or paid, particularly because the TC is not limit of 20 percent for RO participants associated costs, though the RO Model associated with an APM Incentive that have fewer than 60 episodes in the evaluation will analyze health outcomes Payment. A commenter expressed baseline period and were furnishing that occur after RO episodes end to the concern that there could be a great included RT services in the CBSAs extent feasible. The Model is designed degree of variation in episode spending selected for participation at the time of to predict payment based on the outside the control of HOPDs, the effective date of this final rule (see historical characteristics of a particularly those with little experience section III.C.6.e(4) of this final rule). We participant’s population based on the with episode-based payments. are adding a definition at § 512.205 for most recent claims data available. In Several commenters recommended ‘‘stop-loss limit,’’ which means the set particular, we refer readers to section that CMS limit the downside risk for RO percentage at which loss is limited III.C.6.e.(1) concerning the case mix participants, because as proposed, the under the Model used to calculate the adjustments. We update the case mix Model provides no safeguard for stop-loss reconciliation amount. We are adjustment for each RO participant excessive financial downside risk. A also adding at § 512.205 a definition for every year to account for the most recent few commenters recommended ‘‘stop-loss reconciliation amount’’ set of episodes for which claims data is restructuring the Model altogether to which means the amount owed to RO

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participants that have fewer than 60 Response: We thank these incorporate payments for treatment from episodes during 2016–2018 and were commenters for their feedback regarding multiple modalities to the extent that furnishing included RT services in the patients receiving treatment for multiple more than one modality was furnished CBSAs selected for participation at the tumor sites. An episode-based payment during episodes of care in the historical time of the effective date of this final covers all included RT services period. These cases described by the rule for the loss incurred under the furnished to an RO beneficiary during a commenters are part of the set of Model as described in § 512.285(f). 90-day RO episode as codified at historical episodes included in the Thus, we disagree with the premise § 512.205 and § 512.245. Episodes are averages that determine the national that the proposed pricing methodology constructed using all Medicare FFS base rates and contribute to how does not adequately pay RO participants claims for radiation therapy services payment amounts are valued, and, for labor and resources required to care included in the Model. All RT services therefore, an adjustment for multiple for the most complex patients. In included on a paid claim line during the modalities is not warranted at this time. particular, we refer readers to section 90-day episode were multiplied by the Yet, we will be monitoring for change in III.C.6.e.(2) of this final rule for more OPPS or PFS national payment rate for treatment patterns related to patients information regarding the blend used to that service and were included in the being treated with multiple modalities determine how much participant- payment amounts for the PC and TC of throughout the Model performance specific historical payments and that episode regardless of whether the period and will consider modifications national base rates figure into payment. service is aimed at treating the to the pricing methodology in future The blend provides a glide path toward attributed primary disease site or not. years of the Model should it be the national average for each cancer As such, the national base rates warranted. Any changes to the pricing type. Moreover, this is not a total cost incorporate payments for treatment of methodology will be made via notice of care model in that each RO episode multiple tumor sites to the extent that and comment rulemaking. covers only RT services. We limited the more than one site was the focus of RT Comment: A few commenters Model in this way, because we believe services during episodes of care in the requested clarity on whether episode that these RT services are in control of historical period. Bundled episode payment amounts covered all RT the RT provider and RT supplier. For payment rates are premised on the services furnished during a 90-day these reasons, reconfiguring the RO notion of averages. These cases period, even in instances where Model to incorporate either a ‘‘shared described by the commenters are part of multiple courses of treatment were savings’’ element or gradual risk at a the set of historical episodes included in furnished. Several commenters pace determined by RO participants is the averages that determine the national expressed concern that no adjustment not necessary. base rates and contribute to how would be made if multiple courses of payment amounts are valued, and, treatment were furnished within that To ease any burden of adjusting to therefore, an adjustment for multiple 90-day period. and complying with the Model, we are tumor sites is not warranted at this time. Response: An RO episode includes all finalizing policies that reduce the Yet, we will be monitoring for change in included RT services (See Table 2) discount factor by 0.25 percent for both treatment patterns related to patients furnished to an RO beneficiary with an the PC and TC, so that the discount rates being treated for multiple tumor sites included cancer type during the 90-day are 3.75 percent and 4.75 percent for the throughout the Model performance episode as codified at § 512.205 and PC and TC, respectively (see sections period and will consider modifications § 512.245. These cases described by the III.C.6.a and III.C.6.f). See section to the pricing methodology in future commenters are part of the set of § 512.205 for the modification to the years of the Model should it be historical episodes included in the proposed discount factors. Also, we are warranted. Any changes to the pricing averages that determine the national finalizing policies that reduce the methodology will be made via notice base rates and contribute to how incorrect payment withhold to 1 and comment rulemaking. payment amounts are valued and, percent. See section III.C.6.g(1) for the Comment: Several commenters noted therefore, an adjustment for multiple modification to the proposed incorrect that the national base rates for prostate courses of treatment is not warranted at payment withhold. These reductions, as cancer and for gynecological cancers are this time. detailed in the pricing methodology not reflective of the increased costs of Comment: Many commenters component sections to which they combined modality care, but rather suggested that the payment structure be apply, should further minimize any cost these rates are driven by large volumes adjusted to account for patients differential that a participant may of patients who receive external beam receiving treatment for secondary experience under the Model as opposed radiation only. As a consequence, these malignancies. to what the participant historically commenters argued that RO participants Response: An RO episode includes all received in payment under FFS. would not be sufficiently compensated included RT services (See Table 2) Comment: Many commenters for these beneficiaries. furnished to an RO beneficiary with an suggested that the payment structure be Response: As noted in the previous included cancer type during the 90-day adjusted to account for patients comment, an episode-based payment episode. If an RO episode includes RT receiving treatment for multiple tumor covers all included RT services services for different included cancer sites. A commenter stated that a furnished to an RO beneficiary during a types (for example, there may be claims diagnosis of primary lung cancer and 90-day episode as codified at § 512.205 for RT services included in the pricing prophylactic whole brain treatment and § 512.245. All RT services included for that episode that indicate more than would not both be covered by the on a paid claim line during the 90-day one cancer type according to the ICD– national base rate for lung cancer. A episode are multiplied by the OPPS or 10 diagnosis codes listed on the various commenter suggested monitoring the PFS national payment rate for that claims), those RT services and their frequency and cost of care associated service and are included in the payment costs are all included in the calculation with multiple treatment sites in order to amounts for the PC and TC of that of the payment rate for that episode. determine if the pricing methodology episode regardless of the type of We would like to clarify how cancer should be modified in future years on modality used to treat the beneficiary. type is assigned to an episode for this point. As such, the national base rates calculation of the national base rates. It

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is important to note that episodes are among other cancer types is not an Advanced Model, the model participant first assigned a cancer type when the included cancer type. is responsible for Medicare fee-for- episode is created, whether the cancer (c) If there are no claim lines with a service (FFS) expenditures for all items type is included in the Model or not, cancer diagnosis meeting the previously and services included in an episode of and then if that cancer type is not discussed criteria, then no cancer type care starting with the episode trigger. included in the Model, that episode is is assigned to that episode and However, in the RO Model, we have excluded subsequently from Model therefore, that episode is excluded from limited financial risk to RT services pricing. For instance, episodes first the national base rate calculations. whereas the BPCI Advanced Model assigned with a secondary malignancy Comment: A commenter participants are responsible for the total for cancer type during the episode recommended that a payment amount of Medicare spending for non- construction phase are then excluded adjustment be made for the increased excluded items and services in the when pricing calculations are use of Magnetic Resonance simulation episode of care. As described in section conducted. Our process for assigning a that was not present during the baseline III.C.5.c, we believe that it is appropriate cancer type to an episode is as follows: period of 2015–2017 in order to monitor to limit risk in the RO Model just to RT First, ICD–10 diagnosis codes during patient safety and treatment efficacy. services, which are managed by the an episode were identified from: Response: We will be monitoring for radiation oncologist. changes in treatment patterns (1) E&M services with an included Comment: A commenter expressed throughout the Model’s performance cancer diagnosis code from Medicare support for the proposed policies period with particular attention to the PFS claim lines with a date of service related to the definition of incomplete increased use of MR simulation. We will during the 30 days before the episode episodes. A few commenters requested consider proposing modifications to the start date, on the episode start date, or that CMS provide an example pricing methodology in future years of during the 29 days after the episode calculation for how an incomplete the Model should it be warranted. episode would be paid. Another start date. Comment: Many commenters (2) Treatment planning and delivery commenter requested clarification on expressed concern that the pricing the situation of a beneficiary switching services (See Table 2) with an included methodology fails to account for cancer diagnosis code from Medicare RT providers and/or RT suppliers and complex clinical scenarios and how each would be paid if both RT PFS claim lines, or treatment delivery treatment costs. Many commenters providers and/or RT suppliers were services from Medicare OPPS claim recommended that only standard participants in the Model. lines with an included cancer diagnosis medically accepted case rates should be Response: We thank these code on the claim header, with a date used to determine payment. commenters for their support and of service on the episode start date or Response: At this time, we have only requests. As noted in the proposed rule during the 29 days after the episode claims data available to design and and in this final rule, we expect to start date. Note that the cancer diagnosis operationalize the RO Model. The provide RO participants with additional code from OPPS claims must be the claims data do not include clinical data. instructions for billing, particularly as principal diagnosis to count toward We are finalizing our proposal to collect billing pertains to incomplete episodes cancer type assignment; and that clinical data from RO participants so and duplicate RT services, through the treatment delivery services that concern that we can assess the potential utility Medicare Learning Network (MLN image guidance do not count toward of additional clinical data for Matters) publications, model-specific cancer type assignment as we monitoring and calculating episode webinars, and the RO Model website. determined that image guidance was not payment amounts (see section III.C.8.e For a subset of incomplete episodes in an important indicator of cancer type. of this final rule). Further, we believe which (1) the TC is not initiated within Then, these ICD–10 diagnosis codes that the case mix adjustment 28 days following the PC; (2) the RO are summarized and counted across the appropriately accounts for the beneficiary ceases to have traditional claim lines to determine the episode’s complexity of an RO participant’s FFS Medicare prior to the date upon cancer type assignment according to the patient population, and the historical which a TC is initiated, even if that date algorithm described in (a) through (c): experience adjustment captures is within 28 days following the PC; or (a) If two or more claim lines fall additional unmeasured factors that may (3) the RO beneficiary switches RT within brain metastases or bone make one RO participant’s patient provider or RT supplier before all RT metastases or secondary malignancies population more complex, and thus services in the RO episode have been (per the mapping of ICD–10 diagnosis more costly, than another’s. We also furnished the RO participant is owed code to cancer type described in Table believe that the national base rates only what it would have received under 1 of Identified Cancer Types and would be lower if we were to use a FFS for the RT services furnished to that Corresponding ICD–10 Codes), we set standard treatment course to set RO beneficiary, CMS will reconcile the the episode cancer type to the type payments, since there are situations in episode payment for the PC and TC that (either brain metastases or bone which greater volume is used than was paid to the RO participant with metastases) with the highest count. If would be prescribed by a standard what the FFS payments would have the count is tied, we assign the episode course of treatment. been for those RT services using no-pay in the following order of precedence: Comment: A commenter suggested claims. When an RO beneficiary Brain metastases; bone metastases; other assigning an episode of care initiator, switches RT provider or RT supplier, he secondary malignancies. who would be responsible for total or she is no longer under the care of the (b) If there are fewer than two claim spending for the PC and TC, similar to RO participant that initiated the PC and/ lines for brain metastases, bone the BPCI Advanced Model. or TC of the RO episode. metastases and other secondary Response: Similar to the BPCI In the case that traditional Medicare malignancies, we assign the episode the Advanced Model, the RO participants ceases to be the primary payer for an RO cancer type with the highest claim line initiate (or trigger) RO episodes of care beneficiary after the TC of the RO count among all other cancer types. We with an initial service, which is the episode has been initiated but before all exclude the episode if the cancer type treatment planning service in the RO included RT services in the RO episode with the highest claims line count Model. In both the RO Model and BPCI have been furnished, then each RO

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participant will be paid only the first initiated the PC or TC will be reconciled applied under OPPS outside of the installment of the episode payment. The by reducing the RO participant’s Model at 84 FR 34510 of the proposed RO participant will not be paid the EOE episode payment by the FFS amount of rule, and see section III.C.6.h. of this PC or TC for these RO episodes as CMS the duplicate RT services furnished by final rule. We also proposed to use RO cannot process claims for a beneficiary the RT provider or RT supplier that did Model-specific RVU shares to apply PFS with dates of service on or after the date not initiate the PC or TC. The FFS RVU components (Work, PE, and MP) to that traditional Medicare is no longer amount to be subtracted from the RO the new RO Model payment amounts in the primary payer. If the SOE for the PC participant’s bundled payment, the same way they are used to adjust is paid and the RO beneficiary ceases to however, cannot exceed the amount that payments for PFS services in section have traditional Medicare FFS, for the RO participant would receive under III.C.6.h. In order to use RO Model- example by switching to a Medicare FFS for the RT services they furnished specific RVU shares to apply PFS RVU Advantage plan, before the TC is during the RO episode. We note that a components to the new RO Model initiated, then during reconciliation, duplicate RT service is distinct from the payment amounts in the same way they CMS will calculate what the RO situation where an RO beneficiary are used to adjust payments for PFS participant would have received under switches to a different RT provider or services, the geographic adjustment FFS for the RT services included in the RT supplier. As explained above, when must be applied to the trended national PC furnished to that beneficiary prior to an RO beneficiary switches to a new RT base rates prior to the case mix and the beneficiary switching from provider or RT supplier, and is no historical experience adjustments and traditional Medicare to another payer. longer under the care of the RO prior to the discount factor and We account for duplicate RT services participant that initiated the PC and/or withholds. We note that, although differently. In the proposed rule, a TC, the RO episode is an incomplete modifying the sequence of the pricing duplicate RT service means any episode. The RO participant is owed methodology in this way slightly included RT service that is furnished to what it would have received under FFS changes the amount of dollars attributed a single RO beneficiary by a RT provider for the RT services furnished to that RO to the discount factor and to each or RT supplier or both that did not beneficiary, and CMS will use no-pay withhold, the participant-specific initiate the PC or TC for that RO claims to reconcile the episode payment professional episode payment amounts beneficiary during the RO episode. We with what the FFS payments would and the participant-specific technical are finalizing this proposed definition of have been for the RT services. For episode payment amounts do not duplicate RT service with modification. further details, see section III.C.11(b) of change as a result of this modification. Duplicate RT service means any this final rule. We list all modifications to the pricing included RT service identified at In sum, all claims for RT services for methodology at the end of the pricing § 512.235 that is furnished to an RO an RO beneficiary with dates of service methodology section, section III.C.6 of beneficiary by an RT provider or RT during the 90-day RO episode will be this final rule. supplier that is not excluded from reviewed during annual reconciliation, participation in the RO Model at to determine if that RO episode qualifies b. Construction of Episodes Using § 512.210(b), and that did not initiate as complete as stipulated in section Medicare FFS Claims and Calculation of the PC or TC of the RO beneficiary’s RO III.C.11 and codified at § 512.285 and if Episode Payment episode. Such services are furnished in duplicate RT services occurred as For the purpose of calculating the addition to the RT services furnished by defined in section III.C.6a and codified national base rates, case mixes, and the RO participant that initiated the PC at § 512.205. As a consequence of this historical experience adjustments, we or TC and continues to furnish care to process, CMS will determine how all of proposed to construct episodes based on the RO beneficiary during the RO these claims impact the annual dates of service for Medicare FFS claims episode. This modification also clarifies reconciliation amount on an episode-by- paid during the CYs 2015–2017 as well that RT services furnished by a RT episode basis. The sum of payments for as claims that are included under an provider or supplier excluded from duplicate RT services and the sum of episode where the initial treatment participation in the Model (for example, payments for RT services during the planning service occurred during the an ambulatory surgery center, see incomplete episode represent the CYs 2015–2017 as discussed in section section III.C.3.c for exclusion criteria) impact of those duplicate RT services III.C.3.d of the proposed rule and this are not considered a duplicate RT and incomplete episodes across all RO final rule. We proposed to exclude those service. If the EOE PC and TC payments episodes attributed to the RO episodes that do not meet the criteria have been made to the RO participant participant for the PY considered in that discussed in section III.C.5 of this final that initiated the PC or TC of that RO annual reconciliation. See section rule. Each episode and its episode, and claims are submitted on III.C.11 for further details on this corresponding payment amounts, one behalf of that same beneficiary for RT process. Table 14 in that section is an for the PC and one for the TC, would services furnished by another RT example of the annual reconciliation represent the sum totals of calculated provider or RT supplier during that RO calculation. For more information on payment amounts for the professional episode, then during reconciliation, billing under the RO Model, see section services and the technical services of payments for those duplicate RT III.C.7; for more information on the radiation treatment furnished over a services will be reconciled against the reconciliation during the RO Model, see defined 90-day period as discussed in incorrect payment withhold for the RO section III.C.11. section III.C.5.b of this final rule. We participant that received full payment In our proposed eight primary steps to proposed to calculate the payment for the RO episode. The other RT the pricing methodology, we are making amounts for the PC and TC of each provider or RT supplier that furnished one technical change to apply the episode as the product of: (a) The OPPS RT services to that beneficiary, whether geographic adjustment to the trended or PFS national payment rates for each an RO participant or not, will be paid national base rates prior to the case mix of the RT services included in the FFS for those RT services. and historical experience adjustments Model multiplied by (b) the volume of For any RO episode that involves one and prior to the discount factor and each professional or technical RT or more duplicate RT services, the withholds. We proposed to apply the service included on a paid claim line payment for the RO participant that OPPS Pricer as it is automatically during each episode. We proposed to

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neither Winsorize nor cap payment net loss that participants are likely to criteria discussed in section III.C.4 of amounts nor adjust for outliers in this experience under the Model. this final rule. step. Response: We proposed to weight the We proposed to exclude episodes So that all payment amounts are in most recent year in the baseline more without positive (>$0) total payment 2017 dollars, we proposed to convert heavily because this gives more weight amounts for professional services or 2015 payment amounts to 2017 by to the most recent episode data technical services, since we would only multiplying: (a) The 2015 payment available, including the most recent use episodes where the RT services amounts by the ratio of (b) average treatment patterns, not because they are were not denied and Medicare made payment amounts for episodes that the ‘‘lowest’’ rates. Furthermore, since payment for those RT services. We initiated in 2017 to (c) average payment we are moving the dates of service for proposed to exclude episodes that are amounts for episodes that initiated in the construction of episodes up a year not assigned a cancer type and episodes 2015. We proposed to apply this same from CYs 2015–2017 to CYs 2016–2018, assigned a cancer type not on the list of process for episodes starting in 2016. To episodes initiated in 2017 will be Included Cancer Types, since the RO weigh the most recent observations weighted at 30 percent not 50 percent. Model evaluates the furnishing of RT more heavily than those that occurred in We are finalizing this provision with services to beneficiaries who have been earlier years, we would weight episodes modification to construct episodes diagnosed with one of the included that initiated in 2015 at 20 percent, based on dates of service for Medicare cancer types. The remaining proposals episodes that initiated in 2016 at 30 FFS claims paid during the CYs 2016– listed in section III.C.6.c of the proposed percent, and episodes that initiated in 2018 as well as claims that are included rule excluded episodes that are not in 2017 at 50 percent. under an episode where the initial accordance with section III.C.5 of the We proposed that conversion of 2015 treatment planning service occurred proposed rule. and 2016 payment amounts to 2017 during the CYs 2016–2018 as discussed (1) National Base Rate Calculation dollars would be done differently, in section C.III.6 of the proposed rule Methodology and this final rule. To weigh the most depending on which step of the pricing When calculating the national base recent observations more heavily than methodology was being calculated. For rates, we proposed to only use episodes those that occurred in earlier years as instance, episode payments for episodes that meet the following criteria: (1) proposed, we will weight episodes that used to calculate national base rates and Episodes initiated in 2015–2017; (2) case mix regression models would only initiated in 2016 at 20 percent, episodes episodes attributed to an HOPD; and (3) be furnished in the HOPD setting, and that initiated in 2017 at 30 percent, and during an episode, the majority of consequently, for purposes of episodes that initiated in 2018 at 50 technical services were provided in an calculating the national base rates and percent. HOPD (that is, more technical services case mix regression models, the c. National Base Rates were provided in an HOPD than in a conversion of episode payment amounts freestanding radiation therapy center). We proposed to define the term to 2017 dollars would be based on We explained in the proposed rule that ‘‘national base rate’’ to mean the total average payments of episodes from only OPPS payments have been more stable payment amount for the relevant the HOPD setting. On the other hand, over time and have a stronger empirical component of each episode before episode payments for episodes used to foundation than those under the PFS. application of the trend factor, discount calculate the historical experience The OPPS coding and payments for factor, adjustments, and applicable adjustments would be furnished in both radiation oncology have varied less year withholds for each of the included the HOPD and freestanding radiation over year than those in the PFS for the cancer types. We further proposed to therapy center settings (that is, all applicable time period. In addition, codify this term at § 512.205 of our episodes nationally), and consequently, generally speaking, the OPPS payment regulations. for purposes of calculating the historical amounts are derived from information experience adjustments, the conversion The proposed rule would exclude the from hospital cost reports, which are of episode payment amounts to 2017 following episodes from calculations to based on a stronger empirical dollars would be based on average determine the national base rates: • foundation than the PFS payment payments of all episodes nationally Episodes with any services amounts for services involving capital from both the HOPD and freestanding furnished by a CAH; • equipment. radiation therapy center settings. Episodes without positive (>$0) CMS proposed to publish the national Comment: A few commenters total payment amounts for professional base rates and provide each RO disagreed with weighting the most services or technical services; participant its participant-specific • recent episodes more heavily than those Episodes assigned a cancer type not professional episode payment amounts that occurred in earlier years, identified as cancer types that meet our and/or its participant-specific technical specifically weighting episodes that criteria for inclusion in the Model, as episode payment amounts for each initiated in 2015 at 20 percent, episodes discussed in section III.C.5.a of the cancer type no later than 30 days before that initiated in 2016 at 30 percent, and proposed rule (84 FR 34497 through the start of the PY in which payments episodes that initiated in 2017 at 50 34498) and this final rule; in such amounts will be made. percent. A couple of commenters stated • Episodes that are not assigned a Our proposed national base rates for that the 2017 rates were the lowest rates cancer type; the Model performance period based on of all three years in the baseline, yet • Episodes with RT services the criteria set forth for cancer type accounts for 50 percent of the national furnished in Maryland, Vermont, or a inclusion were summarized in Table 3 base rates. A commenter stated that the U.S. Territory; of the proposed rule. average reduction in rates from 2015 to • Episodes in which a PPS-exempt Comment: Many commenters 2017 was 11 percent for all included cancer hospital furnishes the technical disagreed with the proposal for modalities except Conformal External component (is the attributed technical calculating the national base rates based Beam (CEB), which saw an 8 percent provider); on average payment of episodes from increase. Another commenter stated that • Episodes in which a Medicare only the HOPD setting. These the lower 2017 rates would increase the beneficiary does not meet the eligibility commenters stated that utilizing only

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HOPD episodes does not reflect the the PFS rates have been fixed since 2015 in radiation oncology unless it is actual payment experience for and added stability temporarily, but clinically appropriate to do so. We refer freestanding radiation therapy centers, these rates were fixed at the behest of readers to section III.B.3, aligning and that it is inappropriate to base a site professional organizations in radiation payments to quality and value, rather neutral test on HOPD episodes alone. oncology in large part because of their than volume, where the issue of Some commenters questioned CMS’ concerns that those rates were unstable hypofractionation is discussed in detail. rationale for excluding freestanding and under review as being potentially We agree with the comment that using radiation therapy center data from the misvalued. The OPPS rates are HOPD rates would increase payments to calculation of the national base rates. constructed from hospital cost data. freestanding radiation therapy centers, The commenters claim that CMS’ This cost data provides empirical but only if we are considering payment rationale (that is, that HOPDs furnished support for the OPPS rates. The PFS on a per service basis, not when services a lower volume of services and used less rates do not have the same empirical are bundled under an episode of care costly modalities within such episodes cost data backing, as we explained in and paid for accordingly, as will be than did freestanding radiation therapy the proposed rule and in the November done under the RO Model. centers even though HOPDs provided 2017 Report to Congress. We would also Finally, we agree with the more episodes nationally from 2015 like to clarify that, although the national commenters about using more recent through 2017) is not sufficient to base rates in the RO Model are baseline data, and therefore, we are warrant the exclusion of freestanding calculated based on episodes occurring finalizing the calculation of national radiation therapy centers from the in the HOPD setting, these episodes base rates based on HOPD data as calculation of the national base rates. include payments made to physicians proposed with modification to change Another commenter stated that the under the PFS for the PC and payments the baseline from 2015–2017 to 2016– analysis conducted by CMS provides no to freestanding radiation therapy centers 2018. basis to suggest that higher utilization, for the TC in episodes where Comment: Several commenters raised particularly of IMRT in freestanding beneficiaries sought treatment from both concerns regarding the OPPS comprehensive APC (C–APC) radiation therapy centers, is not HOPDs and freestanding radiation methodology. CMS applies this policy medically necessary. Another therapy centers. to certain RT services under the OPPS commenter stated that particularly with We disagree that a blend of PFS and and commenters explained that respect to treatment of prostate cancer, OPPS rates would better account for radiation oncology is better suited for the number of fractions for a course of different care patterns across the component coding to account for several treatment have held constant for nearly different settings of HOPDs and steps in the process of care. The a decade, regardless of site of service. A freestanding radiation therapy centers. commenters also noted that the OPPS few commenters questioned the veracity We believe the argument that the C–APC methodology does not account of the claim that the vast majority of number of fractions has held constant for the several steps in the process of increased utilization is occurring in the for nearly a decade for a course of treatment for prostate cancer, regardless care and fails to capture appropriately freestanding radiation therapy centers coded claims. A few commenters stated and requested that CMS share the of site of service, supports the Model’s move toward site neutrality, in that the that the amount a hospital charges for a details of its calculation that service does not have a direct or freestanding radiation therapy centers settings are comparable, and no matter which site of service is used as the basis consistent relationship to what the received 11 percent higher for payment, it should make no service actually costs, and hospitals reimbursement per episode than difference to treatment outcomes. We often use monthly or repetitive service HOPDs. MedPAC argued that using have found no evidence supporting claims. The commenters suggested that HOPD rates would increase payments to different utilization rates based on CMS monitor the impact of the OPPS freestanding radiation therapy centers setting. For clarity, we have found no methodology on payment rates under and reduce savings for Medicare. evidence to suggest that, on average, the RO Model and consider using the Finally, a few commenters took issues higher utilization rates are warranted for OPPS APC without the C–APC with the premise that OPPS rates have RT services furnished in freestanding methodology for the technical been more stable than the PFS rates, radiation therapy centers than for RT component of the national base rate for since PFS payments for radiation services furnished in the HOPD setting. cervical cancer, in particular. therapy codes have been frozen since We proposed to adopt both case mix Response: We thank the commenters 2015. Using one or more of the and historical experience adjustments to for expressing their concerns regarding previously discussed arguments, many account for the different care patterns of the OPPS C–APC policy that is used to commenters recommended calculating each RO participant specifically, not the pay for certain HOPD-furnished RT the national base rates using a blend of different care patterns of HOPDs and services. We also appreciate their PFS and OPPS rates rather than basing freestanding radiation therapy centers in recommendations regarding monitoring the rates on OPPS rates alone. These general. Furthermore, as patterns of care the impact of these policies on the commenters argued that this blend change over time, we will apply a trend episode payment amounts under the would better account for different care factor to the 32 different national base Model. We refer readers to section patterns across the different sites of rates to account for current trends in III.C.5.a, where we discuss the inclusion service. Additionally, several payment for RT services and the volume of cervical cancer as it relates to the C– commenters recommended CMS use of those services outside of the Model in APC methodology. more recent data than 2015–2017, if both HOPDs and freestanding radiation The purpose of the RO Model is to available. therapy centers. For clarity, we will use test a site-neutral and modality-agnostic Response: We refer readers to the the volume and payment for RT services approach to payment for RT services. November 2017 Report to Congress that experienced in both settings to We determined it was necessary to discusses FFS incentives and the site-of- determine the trend factor. include certain RT services (for service payment differential between As for hypofractionation, the RO example, Stereotactic Radio Surgery) HOPDs and freestanding radiation Model is not intended to make which are subject to the packaging therapy centers in detail. It is true that hypofractionation the standard of care policy under the OPPS in the RO Model

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to help ensure site neutrality and a the comment responses in the overview efficient practices as inefficient modality-agnostic approach. For clarity, of the pricing methodology in section participants. As an example, the we would have likely had to exclude III.C.6.a, where we detail how cancer commenter explained that many certain commonly provided RT services type is assigned to an episode. episodes had more than 10 if we wanted to avoid those codes that Removing episodes determined to be brachytherapy treatment delivery are subject to the OPPS C–APC policy. palliative based solely on a low number services, while other episodes had In addition, the RO Model will calculate of treatments would remove cases where brachytherapy counts 1–10 or 11–20 a single episode payment rate for all of a curative treatment included a low and also 11–20 or 21–30 IMRT/CEB the included RT services for a 90-day number of fractions. We cannot counts. This signals an inconsistency in period. As a result, the impact of any definitively determine if a treatment the way codes were used in COUNT_ one code on the overall episode was palliative in nature based on count BRACHY. The commenter requested payment amount is minimal. We will of fractions, and we do not intend to tie that the code set used for each code monitor the impact of the C–APCs on episode payment to fraction count, count be provided in the data dictionary the episode payment rates. which would keep in place the FFS- that accompanies the episode file on the Comment: Many commenters incentive structure the RO Model RO Model website. expressed concerns regarding the intends to change. We will be Several commenters suggested CMS calculation of the national base rates in monitoring to ensure that episodes of establish tiered base rates rather than a that they believe the rates bone and brain metastasis are single base rate per cancer type. A inappropriately include palliative care appropriately billed under the Model. commenter suggested developing cases and distort the true cost of cancer We will not remove cases that are different base rates based on resource care. A few commenters expressed perceived to be palliative in nature levels and clinical complexity concern about the lung cancer national based on the number of fractions analogous to OPPS ambulatory payment base rates, in particular, and stated that furnished during the episode. classification levels. Similarly, a few 47 percent of the cases were palliative Comment: Many commenters called commenters recommended the national in nature. These commenters argued into question the integrity of data used base rates be stratified based on the that the intent of treatment should to generate the national base rates. Many clinical characteristics of beneficiaries determine pricing in these cases. CMS commenters stated that the national as this significantly affects the number should determine whether these cases base rate calculations inappropriately and type of treatment received, not just are palliative or curative in nature, and include incomplete episodes of care. A by the broad category of cancer they from this, develop separate rates within commenter stated that 14 percent of have. A commenter suggested that this cancer type. HOPD cases look like incomplete cancer stage and intensity of treatment Many commenters suggested that episodes, because they had technical be considered in payment. A commenter removing palliative cases would more charges that were less than $5,000. A suggested that CMS use fewer than 34 accurately account for the cost of commenter estimated that if these different national base rates, because so delivering standard of care in radiation incomplete episodes of care were to be many different rates would cause oncology, but commenters differed on excluded, this would increase the confusion for RO participants that treat which cases would constitute care that national base rates by approximately 16 multiple types of cancers. is palliative in nature. A commenter percent. Response: We thank these suggested removing conformal radiation Another commenter expressed commenters for expressing these therapy treatment with ten or fewer concern about the payment differential concerns and for their suggestions. We fractions and then creating a separate between the average freestanding disagree that incomplete episodes were ‘‘Cancer symptom palliation, not radiation therapy center rate and the inappropriately included in the national otherwise specified’’ episode, asserting average HOPD rate with regard to base rates. We used the same criteria to that pulling these cases out would more prostate cancer. The commenter identify episodes in the baseline as we accurately account for the cost of care. attributed the payment differential, will use in the Model. Only episodes A few commenters suggested removing whereby the freestanding radiation that meet certain criteria, codified at all episodes of 1–10 fractions with 2D or therapy center rate was 7.5 percent § 512.250, would be included in the 3D management and removing non- higher than the average HOPD rate, to national base rate calculation and in the SBRT episodes. Another commenter the additional $4,000 per episode for calculation of the trend factor, case mix noted that even treatment courses of 11– brachytherapy. and historical experience adjustments. 20 fractions have high probability of A commenter stated that a few We are finalizing episode exclusion being palliative episodes. providers and suppliers account for a criteria with a few clarifications. We are Response: In assigning cancer types, large percentage of the total amount of clarifying that we exclude episodes in we created the Model to be as sensitive episodes and that these providers and the baseline which are not attributed to as possible in identifying palliative suppliers could have a disproportionate an RT provider or RT supplier, an cases, including bone and brain impact on the setting of the national exceedingly rare case (less than 15 metastasis cases. We believe the base rates, homogenizing the data used episodes out of more than 518,000 methodology we use to assign cancer to set those rates, and therefore, the episodes in the baseline period) where types, which preferences assignment of method of calculating the national base the only RT delivery services in the bone and brain metastasis cases, rates should be reconsidered. Several episode are classified as professional appropriately captures those clinical commenters stated that non-standard services (because there are a few circumstances where a beneficiary was treatment episodes are included in the brachytherapy surgery services that are treated not for cancer at the original site calculation of the national base rates, categorized as professional services). We but for metastasis to the bone or brain, and as a consequence, artificially are also clarifying that episodes are respectively. Other palliative cases depress actual cost. In a similar vein, a excluded if either the PC or TC is described by the commenters are part of commenter added that artificially low attributed to an RT provider or RT the set of historical episodes for other payments caused by coding errors and supplier with a U.S. Territory service cancer types and are included in their billing infrequency in the HOPD setting location or to a PPS-exempt entity. national base rates. We refer readers to may cause CMS to qualify otherwise However, services within an episode

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provided in a US Territory or provided and calculating episode payment providers and suppliers to be accurate by a PPS-exempt entity are included in amounts (see section III.C.8.e). We do per Medicare rules and regulations. We the episode pricing. Thus, for the not have the clinical or resource level refer readers to the comment responses constructed episodes used to determine data to design tiered base rates as in the overview of pricing methodology the baseline, we will include the costs several commenters suggested. Further, in section III.C.6.a, where we detail how of any services provided by such an RT we believe that the case mix adjustment cancer type is assigned to each episode. provider or RT supplier, as long as the appropriately accounts for the We believe this approach appropriately RT provider or RT supplier does not complexity of an RO participant’s captures episodes for the treatment of provide the majority of either the patient population, and the historical metastases by prioritizing assignment to professional or technical services, in experience adjustment captures those cancer types. which case the PC or TC would be additional unmeasured factors that may Comment: Several commenters stated attributed to the entity and the episode make one RO participant’s patient that data integrity is challenged by the would be excluded. We are also population more complex, and thus ICD–9 and ICD–10 diagnosis coding. clarifying that episodes are excluded if more costly, than another’s. Similarly, Many commenters requested more they include any RT service furnished no resource databases are available that detail on how diagnosis codes are by a CAH. Further, we are clarifying that have the kind of data necessary to assigned. A few commenters stated that we exclude all Maryland and Vermont determine national base rates for a the episode file on the RO Model claims before episodes are constructed generalizable sample of Medicare FFS website had each episode classified by and attributed to an RT provider or RT beneficiaries. We believe the best way to disease site but not by ICD–9 or ICD–10 supplier. For this reason, there are not calculate prospective payment rates is to and requested that ICD–9 and ICD–10 episodes in which either the PC or TC look to what we have historically paid codes be made available in the episode is attributed to an RT provider or RT for those episodes based on treatment file for review along with a guide on supplier with a Maryland or Vermont patterns in claims and historical how these codes are mapped to the service location. We similarly exclude payment rates, and then trend these corresponding disease site. A few inpatient and ASC claims from episode amounts forward. We believe that commenters noted concern about the construction and attribution. treatment patterns as reflected in the transition from ICD–9 to ICD–10 coding Episodes are not excluded based on episode file represent the variation in systems and called into question any clinical standards of care or based care patterns currently delivered providers’ and suppliers’ coding on the size of HOPD that furnished the nationally. We can only account for accuracy when using the new ICD–10 episode. We also do not use the size of codes that have been submitted in code set alongside the 1-year grace RT providers or RT suppliers, that is, claims. We cannot account for coding or period that was granted for using the the number of episodes that a given RT submission errors made on the part of ICD–9 code set. A commenters provider or RT supplier furnishes, as a RT providers or RT suppliers, unless requested specifically that the algorithm measure of exclusion. We disagree that they have been corrected appropriately for metastatic brain and breast ICD the national base rate calculation should in claims. Furthermore, using fewer codes be made public. account for size of the RT provider or than 32 different national base rates Response: We rely on the data RT supplier, as we do not believe that would not appropriately compensate RO submitted on claims by providers and large RT providers and RT suppliers participants for the cancer type they are suppliers to be accurate per Medicare make up a disproportionate share of the treating and the component they are rules and regulations. The mapping of episodes in the calculation of the furnishing, whether professional or ICD–10 diagnosis codes to cancer type national base rates. As long as HOPD technical. Based on a full review of is described in Table 1. We believe episodes meet inclusion criteria as comments and the detailed analyses sufficient information was provided in stated in section III.C.6.c, they will be contained within some of them, we the episode file available on RO Model included in the calculation of the believe that commenters have had website to allow comment. We are national base rates, regardless of the size sufficient detail to fully comment on the finalizing the calculation of national of the RT provider or RT supplier where proposed RO Model. base rates based on HOPD data as the episode was furnished. It is Comment: Many commenters also proposed with modification to change important to note that the cost of RT expressed concern about the way in the baseline from 2015–2017 to 2016– services vary by modality and cancer which primary and secondary 2018. This modification reduces the risk type, and although payment malignancies are coded, suggesting that of coding errors that could result from differentials may exist across episodes improper coding could skew the the transition from ICD–9 to ICD–10 due to the use of multiple modalities as national base rates. These commenters codes. a commenter stated, we believe that suggested that the presence of low cost Comment: Many commenters using a blend to determine payment episodes in the episode file posted on disagreed with the proposal to include (that is, a blending of participant- the RO Model website are likely proton beam therapy in the calculation specific historical payments with misattributed to a primary disease site of the national base rates. MedPAC, national base rates to determine and should have been attributed to a however, expressed support of CMS’ payment) allows us to balance the palliative care site and should not have proposal to include PBT in the Model. national context (as represented by the been included in the calculation of the MedPAC explained that Medicare’s spectrum of HOPDs nationally) with base rate of the attributed primary payment rates for PBT are substantially participant experience. disease site. higher than for other types of external Furthermore, we have only claims Response: The pricing methodology beam radiation therapy. Additionally, data available to design and does not attempt to assign cancer types the use of PBT has expanded in recent operationalize the RO Model. These using clinical logic of primary and years from pediatric and rare adult claims data do not include clinical data, secondary cancers, but rather follows a cancers to include more common types which is why we are finalizing our plurality rule based on E&M services, of cancer, such as prostate and lung proposal to collect clinical data from RO treatment planning services, and cancer, despite a lack of evidence that participants to assess the potential treatment delivery services. We rely on it offers a clinical advantage over utility of additional data for monitoring the data submitted on claims by alternative treatments for these types of

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cancer. Some commenters believe that adjustments. These values are all greater differences of rounding at one step including PBT in the episode payment than $0. versus another during payment would create an incentive to use lower- Comment: Several commenters processing between a preliminary cost, comparable modalities. disagreed with the proposal to provide estimate and what actually occurs Many commenters stated that the each RO participant its participant- during claims processing could create national base rates do not include a specific professional episode payment some small discrepancies. Third, any meaningful volume of PBT episodes in and/or its participant-specific technical estimate of the participant-specific the calculation and, therefore, the episode payment for each cancer type professional episode payment amounts payment rates are not reflective of the no later than 30 days before the start of would not include any payment cost of providing PBT, and, if finalized, the PY in which payments in such adjustments due under MIPS. Fourth, would lead to significant cuts. Several amounts would be made, explaining the participant-specific technical commenters called attention to the that 30-day notice is insufficient. A few payment amounts would not include national base rate for head and neck commenters proposed 60-day notice and possible additional payments that cancer in that PBT does not statistically a commenter proposed 90-day notice Medicare would make in the event that contribute to that rate, only accounting similar to the notice given to the beneficiary coinsurance is capped at for 0.8 percent of all modalities used, 18 participants of the CJR Model. the inpatient deductible limit under of which were boost treatments. Response: Because the RO payment OPPS. These issues taken together will Therefore, a large cohort of patients amounts incorporate the PFS and OPPS leave a discrepancy (and the size of the incurs costs below the cost of the payment rates in the trend factor, the discrepancy will vary among RO standard episode of care for head and participant-specific professional and participants) between what CMS could neck cancer. Many commenters technical episode payment amounts are estimate the participant-specific recommended that PBT-specific dependent upon publication of the PFS professional and technical episode and OPPS final payment rules for the national base rates be developed to payment amounts to be before the PY upcoming calendar year. These payment reflect the high value resources and begins and what RO participants regulations are statutorily required to be patient complexity that is unique to actually receive. Therefore, CMS will 60 days in advance of the start of a patients that require PBT. provide each RO participant its case mix calendar year. CMS then subsequently and historical experience adjustments Response: We thank these performs calculations to determine the commenters for expressing their for both the professional and technical RO Model trend factor and then creates components, rather than their concerns and for their suggestions. RO the participant-specific professional and Model payments are designed to be participant-specific professional and technical episode payment amounts. We technical episode payment amounts, at disease specific and agnostic to may notify RO participants of these least thirty (30) days prior to the start of treatment and modality type. We believe adjustments prior to the 30-day notice the PY to which those adjustments that using a blend to determine payment deadline to the extent possible. As apply. (that is, a blending of participant- noted in the proposed rule, even though specific historical payments with the Model will establish a common After considering public comments on national base rates to determine payment amount for the same RT the proposed national base rates, we are payment), whereby a large share of the services regardless of where they are finalizing as proposed the determination payment calculation is determined by furnished, payment will still be of national base rate as codified at historical payments will appropriately processed through the current claims § 512.250. We are finalizing our account for the difference in payment systems, with geographic adjustments as proposal with one technical change. We for PBT. We refer readers to section discussed in section III.C.7 of the are modifying the regulatory text at III.C.5.d for discussion of PBT. proposed and this final rule, for OPPS § 512.255 to specify that 30 days before Comment: A couple of commenters and PFS. the start of each performance year, CMS noted that the episode file contained We are noting one technical change. will provide each RO participant its episodes where the professional pay and CMS will provide each RO participant case mix and historical experience technical pay categories had a $0 value its case mix and historical experience adjustments for both the professional and requested clarity on how this data adjustments for both the PC and TC in and technical components. We are also would be included in the analysis. advance of the PY, rather than their finalizing the calculation of national Response: Some payment variables on participant-specific professional and base rates with a modification from the the episode file that was made available technical episode payment amounts, proposed rule that changes the baseline under the NPRM had missing values by because exact figures for the participant- from 2015–2017 to 2016–2018 and a design. For example, the RADONC_ specific professional and technical modification to exclude episodes from PRO_PAY, RADONC_TECH_PAY, episode payment amounts cannot be the baseline in which either the PC or RADONC_PRO_PAY_WINSORIZED_ known prior to claims processing for TC is attributed to a provider with a OPD, and RADONC_TECH_PAY_ several reasons. Maryland, Vermont, or US Territory WINSORIZED_OPD variables have First, we are only able to provide service location, rather than exclude values set to ‘‘missing’’ for episodes in estimates for geographic adjustment episodes with RT services furnished in the free-standing facility setting because based on the payment area(s) in which Maryland, Vermont, or a U.S. Territory they are not used for payment-related an RO participant furnishes included as proposed. Our 32 national base rates purposes under the Model. The RT services. The exact geographic for the Model performance period based variables RADONC_PRO_PAY_ adjustment will vary based on the on the criteria set forth for cancer type WINSORIZED_ALL and RADONC_ location billed by the RO participant, so inclusion are summarized in Table 3 TECH_PAY_WINSORIZED_ALL are the actual payments calculated by CMS’ (noting the removal of kidney cancer fully populated because they are used in payment contractors may be different from the list of included cancer types creating historical experience from preliminary estimates. Second, any discussed in section III.C.5.c).

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d. Proposal To Apply Trend Factors to of each cancer type using data from type, we proposed to calculate a ratio of: National Base Rates HOPDs and freestanding radiation (a) Volume-weighted FFS payment rates therapy centers not participating in the for RT services included in that We proposed to next apply a trend Model. The 34 separate trend factors component for that cancer type in the factor to the 34 different national base would be updated and applied to the upcoming PY (that is, numerator) to (b) rates in Table 3 of the proposed rule. national base rates prior to the start of volume-weighted FFS payment rates for For each PY, we would calculate each PY (for which they would apply) RT services included in that component separate trend factors for the PC and TC so as to account for trends in payment for that cancer type in the most recent rates and volume for RT services outside baseline year (that is, the denominator), 41 The final HCPCS codes specific to the RO of the Model under OPPS and PFS. which will be FFS rates from 2017. Model would be published in an upcoming quarterly update of the CY2020 Level 2 HCPCS For the PC of each included cancer To calculate the numerator, we code file. type and the TC of each included cancer proposed to multiply: (a) The average

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number of times each HCPCS code recent, complete calendar year of data of each cancer type just as there were for (relevant to the component and the available. Several commenters, development of the national base rates. cancer type for which the trend factor however, opposed the application of the For the PC of each included cancer type will be applied) was furnished for the trend factor as proposed for various and the TC of each included cancer most recent calendar year with complete reasons. Several commenters stated that type, we will calculate as proposed a data 42 by (b) the corresponding FFS the trend factor will reflect macro ratio of: (a) Volume-weighted FFS payment rate (as paid under OPPS or changes to reimbursement and payment rates for RT services included PFS) for the upcoming performance utilization, not practice-specific in that component for that cancer type year. technology acquisition and, therefore, in the upcoming PY (that is, numerator) To calculate the denominator, we the trend factor will not provide an to (b) volume-weighted FFS payment proposed to multiply: (a) The average adequate safeguard for innovation rates for RT services included in that number of times each HCPCS code before technology has a significant component for that cancer type in the (relevant to the component and the foothold in the marketplace. Many most recent baseline year (that is, the cancer type for which the trend factor commenters stated that the trend factor denominator), which will be FFS rates will be applied) was furnished in 2017 is not nuanced enough and will from 2018 rather than 2017 as was (the most recent year used to calculate disadvantage providers and suppliers proposed. the national base rates) by (b) the who care for higher risk patients. Many We would like to clarify how RT corresponding FFS payment rate in commenters expressed concern with the services that are contractor-priced under 2017. The volume of HCPCS codes delay between any increase in episode MPFS are incorporated into Model determining the numerator and cost occurring outside of the Model pricing. Instead of relying on the CMS- denominator would be derived from among non-participants and the time it determined resource-based relative non-participant episodes that would be would take to be reflected in the trend value units (RVUs) to establish the otherwise eligible for Model pricing. For factor. A commenter opposed the trend payment rate under the MPFS, Medicare example, for PY1, we would calculate factor as proposed if it would result in Administrative Contractors (MACs) the trend factor as: lower base rates. determine the payment rate for 2020 Trend factor = (2017 volume * Many commenters suggested contractor-priced services. This rate is 2020 corresponding FFS rates as modifications to the proposed trend used by the MAC in their respective paid under OPPS or PFS)/(2017 factor. Several commenters suggested jurisdiction. Payment rates across MAC volume * 2017 corresponding FFS that CMS trend payment amounts based jurisdictions can vary. Due to the rates as paid under OPPS or PFS) on changes in the cost of technologies potential differences across We proposed to then multiply: (a) The and the mix of treatments that evidence jurisdictions, we will calculate the average paid amounts for each year in trend factor for each national base rate indicates is appropriate. In a similar vein, several commenters suggested that the baseline period for each of these RT by (b) the corresponding national base in addition to the trend factor, CMS services to determine their average paid rate for the PC and TC of each cancer adopt a rate review mechanism whereby amount that will be used in the type from Step 1, yielding a PC and a RO participants could make the case for calculation of the national base rates. TC trended national base rate for each participant-specific rate modifications We will use the most recent calendar included cancer type. The trended based on added service lines. Similarly, year with claims data available to national base rates for 2020 would be a few commenters suggested carve out determine the average paid amounts for made available on the RO Model’s payments for new service lines. For the these contractor-priced RT services that website once CMS issues the CY 2020 RO participants that introduced a new will be used in the calculation of the OPPS and PFS final rules that establish radiation oncology service line in a trend factors for the PC and TC of each payment rates for the year. given period of time, for example, they cancer type. For instance, for the 2021 To the extent that CMS introduces would be eligible for a carve-out trend factor, we will calculate the new HCPCS codes that CMS determines payment for part of the Model’s average paid amounts for these should be included in the Model, we performance period. contractor-priced RT services using the proposed to cross-walk the volume One commenter suggested using only allowed charges listed on 2018 claims. based on the existing set of codes to any OPPS data to determine the trend For the 2022 trend factor, we will new set of codes as we do in the PFS factors for the TC of the national base calculate the average paid amounts for rate-setting process.43 rates. Another commenter suggested these contractor-priced RT services We proposed to use this trend factor including RO participant data in the using the allowed charges listed on the methodology as part of the RO Model’s calculation of the trend factor. Another 2019 claims, and so forth. pricing methodology. commenter suggested recalculating the We will calculate the numerator as The following is a summary of the trend factor denominator based on a proposed and multiply: (a) The average public comments received on the more recent year rather than 2017. number of times each HCPCS code proposal to apply trend factors to Several commenters requested (relevant to the component and the national base rates and our responses to clarification as to how the trend factor cancer type for which the trend factor those comments: is calculated. A few commenters will be applied) was furnished for the Comment: A few commenters requested clarity specifically as to most recent calendar year with complete expressed support for the proposal to which fee schedules CMS will use to data by (b) the corresponding FFS update the trend factor using the most calculate the trend factors. payment rate (as paid under OPPS or Response: We will calculate unique PFS) for the upcoming PY. It is 42 For 2020 (PY1), the most recent year with complete episode data would be 2017; for 2021 trend factors for the PC and TC important to note that for PY1 (2021), (PY2), the most recent year with complete episode separately for each cancer type, since the most recent year with complete data would be 2018. the number and types of RT services episode data will be 2018, not 2017, as 43 The process of cross-walking the volume from within episodes vary across the PC and proposed. This mirrors the final policy a previous set of codes to the new set of codes in rate-setting for the PFS was most recently explained TC of each cancer type, and there is to change the baseline from 2015–2017 in the CY 2013 PFS Final Rule, 77 FR 68891, sufficient national data to develop to 2016–2018 with respect to the 68996–68997. separate trend factors for the PC and TC calculation of the national base rates.

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We would like to clarify that volume- individual providers and suppliers, In developing the proposed rule, we weighted FFS payment rate means a such as practice-specific technology consulted clinical experts in radiation weighted average of all of the included acquisition. Furthermore, we do not oncology concerning potential case mix RT services’ FFS payment rates, where want to incorporate RO participants’ variables believed to be predictive of the frequency of each RT service episodes (RO episodes) in the trend cost. We then tested and evaluated these determines its relative contribution to factor calculation, because we do not potential case mix variables and found the calculation. want to penalize RO participants for any several variables (cancer type; age; sex; We will calculate the denominator as efficiencies gained during the Model. A presence of a major procedure; death proposed and multiply: (a) The average rate-review mechanism is not practical during the first 30 days, second 30 days, number of times each HCPCS code at this time. We will monitor the or last 30 days of the episode; and (relevant to the component and the adequacy of payments over time, presence of chemotherapy) to be cancer type for which the trend factor including the trend factor and consider strongly and reliably predictive of cost will be applying) was furnished in 2018 re-baselining in the later PY if analysis under the FFS payment system. (and not 2017 as proposed), since this indicates it is necessary. Based on the results of this testing, we is the most recent year used to calculate We are finalizing policies in this proposed to develop a case mix the national base rates by (b) the section as proposed with a modification adjustment, measuring the occurrence of corresponding FFS payment rate in to the years used in the trend factor’s the case mix variables among the 2018 (and not 2017 as proposed). The numerator and denominator calculation. beneficiary population that each RO volume of HCPCS codes, which For the trend factor’s numerator participant has treated historically (that determines the numerator and calculation, the most recent calendar is, among beneficiaries whose episodes denominator of the trend factors, will be year with complete data used to have been attributed to the RO derived as proposed from non- determine the average number of times participant during 2015–2017) participant episodes that would be each HCPCS code was furnished will be compared to the occurrence of these otherwise eligible for Model pricing. For 2018 for PY1, 2019 for PY2, and so variables in the national beneficiary example, for PY1, we will calculate the forth. We note that the corresponding profile. The national beneficiary profile trend factor as: FFS payment rate (as paid under the was developed from the same episodes 2021 (PY1) Trend factor = (2018 volume OPPS and PFS) included in the used to determine the Model’s national * 2021 corresponding FFS rates as numerator calculation is still that of the base rates, that is 2015–2017 episodes upcoming PY (2021 payment rates for attributed to all HOPDs nationally. We paid under OPPS or PFS)/(2018 PY1, 2022 payment rates for PY2, and would first Winsorize, or cap, the volume * 2018 corresponding FFS so forth). The trend factor’s denominator episode payments in the national rates as paid under OPPS or PFS) calculation will use data from 2018 to beneficiary profile at the 99th and 1st It is important to note that the trend determine: (a) The average number of percentiles, with the percentiles being factors will be based on service volumes times each HCPCS code (relevant to the identified separately by cancer type. We from episodes attributed to both HOPDs component and the cancer type for proposed to use OLS regression models, and freestanding radiation therapy which the trend factor will be applying) one for the PC and one for the TC, to centers, and both PFS and OPPS fee was furnished; and (b) the identify the relationship between schedules will be used to create the corresponding FFS payment rate. As episode payments and the case mix annual trend factors. The use of trend described in the proposed rule, the variables. The regression models would factors based on updated PFS and OPPS denominator does not change over the measure how much of the variation in rates ensures that spending under the Model’s performance period unless we episode payments can be attributed to RO Model does not diverge too far from propose to rebaseline, which we would variation in the case mix variables. spending under the FFS that non- propose through future rulemaking. The regression models generate participants will receive for the coefficients, which are values that underlying bundle of services had they e. Adjustment for Case Mix and describe how change in episode been in the Model. The trend factors Historical Experience payment corresponds to the unit change will only generate significant swings if In the proposed rule, we proposed of the case mix variables. From the there are large swings in payment rates that after applying the trend factor in coefficients, we proposed to determine for RT services that are frequently used section III.C.6.d of the proposed rule (84 an RO participant’s predicted payments, during episodes, which is unlikely to be FR 34506 through 34507), we would or the payments predicted under the the case. If there are big swings upward, adjust the 34 trended national base rates FFS payment system for an episode of that is, OPPS or PFS rates or service to account for each RO participant’s care as a function of the characteristics volumes increase, then RO participants historical experience and case mix of the RO participant’s beneficiary would receive the corresponding history. population. As proposed, for PY1, these increases. Conversely, if there were big predicted payments would be based on swings downward, spending under the (1) Case Mix Adjustments episode data from 2015 to 2017. These RO Model would become unsustainably As explained in the proposed rule, the predicted payments would be summed high comparable to the FFS alternative cost of care can vary according to many across all episodes attributed to the RO if we did not apply a negative trend factors that are beyond a health care participant to determine a single factor, so RO participants would receive provider’s control, and the presence of predicted payment for the PC or the TC. the corresponding decreases. certain factors, otherwise referred to This process would be carried out As for considerations of innovation here as case mix variables, may vary separately for the PC and the TC. and added service lines, the trend factor systematically among providers and We proposed to then determine an RO will reflect updates to input prices as suppliers and warrant adjustment in participant’s expected payments or the reflected in updated PFS and OPPS payment. For this reason, we proposed payments expected when a participant’s rates. Prospective payments in general, to apply an RO participant-specific case case mix (other than cancer type) is not including episode-based payment rates mix adjustment for the PC and the TC considered in the calculation. To do of the RO Model, are not designed to that would be applied to the trended this, we would use the average reflect specific investment decisions of national base rates. Winsorized episode payment made for

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each cancer type in the national As discussed in the proposed rule, the greater than 0.0, the efficiency factor beneficiary profile. These average historical experience adjustment for the would decrease over time to reduce the Winsorized episode payments by cancer PC would be calculated as the difference impact of historical practice patterns on type would be applied to all episodes between: The sum of (a) Winsorized payment over the Model’s performance attributed to the RO participant to payments for episodes attributed to the period. More specifically, for RO determine the expected payments. RO participant during 2015–2017 and participants with a PC or TC historical These expected payments would be (b) the summed predicted payments experience adjustment with a value summed across all episodes attributed from the case mix adjustment greater than 0.0, we proposed that the to an RO participant to determine a calculation, which will then be divided efficiency factor would be 0.90 in PY1, single expected payment for the PC or by (c) the summed expected payments 0.85 in PY2, 0.80 in PY3, 0.75 in PY4 the TC. The difference between an RO used in the case mix adjustment and 0.70 in PY5. For those RO participant’s predicted payment and an calculations. We proposed to repeat participants with a PC or TC historical RO participant’s expected payment, these same calculations for the experience adjustment with a value divided by the expected payment, historical experience adjustment for the equal to or less than 0.0, the efficiency would constitute either the PC or the TC TC. In the proposed rule, we explained factor would be fixed at 0.90 over the case mix adjustment for that RO that mathematically, for episodes Model’s performance period. The participant. In the proposed rule, we attributed to the RO participant, this following is a summary of the public explained that mathematically this would be expressed as: comments received on the proposed would be expressed this as follows: Historical experience adjustment = case mix adjustment and historical Case mix adjustment = (Predicted (Winsorized payments ¥ Predicted experience adjustments, and our payment ¥ Expected payment)/ payments)/Expected payments responses to those comments. Comment: Several commenters Expected payment Based on our calculation, if an RO expressed support for the proposal to The proposed rule noted that neither participant’s Winsorized episode have case mix and historical experience the national beneficiary profile nor the payments (determined from the adjustments. These commenters stated regression model’s coefficients would retrospectively constructed episodes that these adjustments would account change over the course of the Model’s from 2015–2017 claims data) are equal for RO participants’ varied historical performance period. The coefficients to or less than the predicted payments uses of more or less expensive would be applied to a rolling 3-year set used to determine the case mix modalities and treatment decisions that of episodes attributed to the RO adjustments, then it would have may be impacted by patient participant so that an RO participant’s historical experience adjustments with a demographics. case mix adjustments take into account value equal to or less than 0.0, and be Response: We thank these more recent changes in the case mix of categorized as historically efficient commenters for their support of these their beneficiary population. For compared to the payments predicted adjustments. example, we proposed to use data from under the FFS payment system for an Comment: A couple of commenters 2015–2017 for PY1, data from 2016– episode of care as a function of the expressed concern that the Model does 2018 for PY2, data from 2017–2019 for characteristics of the RO participant’s not address equipment replacement or PY3, etc. beneficiary population. Conversely, if upgrades. A few commenters suggested an RO participant’s episode payments that CMS adopt a rate review (2) Historical Experience Adjustments are greater than the predicted payments and Blend (Efficiency Factor in mechanism for new service lines and used to determine the case mix upgrades. Another commenter used the Proposed Rule) adjustments, then it would have example of providers and suppliers who To determine historical experience historical experience adjustments with a add PBT centers and therefore lack adjustments for an RO participant we value greater than 0.0 and be evidence of historical pricing in their proposed to use episodes attributed to categorized as historically inefficient claims data—in such cases, this the RO participant that initiated during compared to the payments predicted commenter recommends exempting 2015–2017. We proposed to calculate a under the FFS payment system for an these new service line modalities for historical experience adjustment for the episode of care as a function of the three years until the modality and PC (that is, a professional historical characteristics of the RO participant’s higher payment is accurately accounted experience adjustment) and the TC (that beneficiary population. The historical for in the practice’s historical claims is, a technical historical experience experience adjustments would be data. adjustment) based on attributed weighted differently and therefore, Response: We appreciate the episodes. For purposes of determining applied to payment (that is the trended commenters’ recommendations. In historical experience adjustments, we national base rates after the participant- section III.C.6.d of this final rule, we proposed to use episodes as discussed specific case mix adjustments have been respond to comments related to added in section III.C.6.b of this final rule (that applied) differently, depending on these service lines. We note that prospective is, all episodes nationally), except we categories. To do this, we proposed to payments in general, including episode- proposed to Winsorize, or cap, episode use an efficiency factor. Efficiency factor based payment rates of the RO Model, payments attributed to the RO means the weight that an RO are not designed to reflect specific participant at the 99th and 1st participant’s historical experience investment decisions of individual percentiles. These Winsorization adjustments are given over the course of providers and suppliers, such as thresholds would be the same the Model’s performance period, practice-specific technology acquisition. Winsorization thresholds used in the depending on whether the RO We did not propose to re-baseline case mix adjustment calculation. We participant’s historical experience participants during the model to avoid would then sum these payments adjustments fall into the historically a possible reduction in payment due to separately for the PC and TC. As with efficient or historically inefficient participants becoming more efficient the case mix adjustments, the historical category. during the model, but we would experience adjustments will not vary by For RO participants with historical consider balancing this consideration cancer type. experience adjustments with a value against the issue of new service lines as

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the model is implemented. We will commenter argued that the case mix These experts advised that utilization monitor for this occurrence and if adjustment disregards the differences and expenditures are influenced by the necessary propose a method to support between the case mix of freestanding presence of any major procedure, and this in future rulemaking. radiation therapy centers and HOPDs. not just cancer-related procedures. Comment: Several commenters Many commenters suggested that the Cancer type is included in the case mix recommended that CMS design the case case mix adjustment be based on adjustment to capture the proportionate mix and historical experience beneficiary characteristics that affect the share of each cancer type in an RO adjustments to be cancer-specific rather appropriate type and amount of participant’s beneficiary population and than participant-specific as it is evidence-based treatment that is assess the resulting effects of the currently proposed. reflected in clinical data. These particular mix of cancer types treated by Response: There are not enough commenters suggested a variety of that RO participant on cost. episodes to design a separate case mix clinical factors should be accounted for As noted in response to comments adjustment approach for each cancer in the case mix adjustment. Commenters concerning the national base rates, we type, so we have chosen to create a stated such factors as disease stage, line have only claims data available to single case mix adjustment approach of treatment, comorbidities, treatment design and operationalize the RO across all cancer types. The case mix intent, and change in patient acuity over Model. The claims data do not include model incorporates cancer type and so the course of the episode. A couple of clinical data. We are finalizing our the RO participant-specific case mix commenters recommended that social proposal to collect clinical data from RO adjustment for the PC and the TC determinants of health be incorporated participants so that we can assess the reflects the case mix of the participant’s into the calculation of the case mix potential utility of additional clinical population including variation in the adjustment. A commenter requested that data for monitoring and calculating cancer types treated. The same is true CMS derive each beneficiary’s HCC episode payment amounts (see section for the approach taken for the historical score or NCI comorbidity index, test that III.C.8.e). experience adjustment. variable in the regression models, and The case mix approach we adopt in Comment: A commenter suggested disclose the results. Another commenter the Model has the goal of reflecting the that aside from the case mix and suggested differing payments based on a net impact of the case mix variables historical experience adjustments, CMS participant’s patient risk levels. after controlling for cancer type, which should adjust payments to account for Several commenters requested clarity is already accounted for in the national the higher cost of delivering RT services on the ordinary least squares regression base rates. We believe that the case mix in rural communities than in urban model that derives the case mix adjustment will provide a consistent settings. adjustments. Several commenters asked adjustment approach to the case mix of Response: Generally, CBSAs do not why cancer type is included in the case episodes furnished by RO participants include the extreme rural regions. In mix adjustment. A few commenters in both the HOPD and freestanding cases where RO participants are requested that CMS clarify the weight of radiation therapy center settings. It is furnishing RT services in rural each variable used to calculate the case true that we have designed the pricing communities, the historical experience mix adjustment. A few commenters methodology around HOPD episode adjustment will account for those RO requested examples regarding the utilization and expenditure patterns, participants’ historical care patterns and calculation of predicted payments and and that the case mix adjustment is their relative cost. expected payments that determine the designed to measure the occurrence of Comment: Many commenters case mix and historical adjustments. A the case mix variables among the expressed concern over the case mix commenter specifically requested how beneficiary population that each RO adjustments. A few commenters chemotherapy and major procedures are participant has treated historically in suggested that rather than deriving the defined under the RO Model and the most recent 3-year set of data with case mix adjustments from a rolling suggested that the definitions align with complete episodes available (that is, three-year average, CMS should the OCM to promote alignment between among beneficiaries whose episodes implement a static baseline, while other the two models. have been attributed to the RO commenters suggested that the Response: We thank these participant during 2016–2018 in PY1 coefficients of the case mix adjustment commenters for expressing their and 2017–2019 in PY2, etc.) relative to formula should change annually. A concerns and suggestions regarding the the occurrence of these variables in the commenter suggested that a health care case mix adjustment. The case mix national beneficiary profile. The RO provider’s case mix adjustment should adjustment is designed to adjust Model, a prospective episode-based reflect the beneficiaries they treated in payment rates for demographic payment model, requires a time lag the current performance year rather than characteristics, presence of between the years on which the a beneficiary cohort for a few years chemotherapy, presence of major adjustment data is based and the year it earlier. A few commenters stated that procedures, and death rates. We call is applied to payment, precisely because the time lag between the years on which these the case mix variables. With it is prospective in nature. Since the the adjustment data is based and its respect to chemotherapy, we define national base rate calculations are application to payment was especially chemotherapy using the same premised on HOPD episodes nationally, problematic for the use of mortality rate definitions and coding lists as OCM. so too is the case mix model and the as a case mix variable. These With respect to major procedures, the case mix coefficients built upon these commenters explained that death during list of major procedure codes for episodes, so differences in an episode and the timing of when a radiation oncology goes beyond the list characteristics between that HOPD- patient died has the largest impact on a of cancer-related surgeries used in based national beneficiary population health care provider’s case mix OCM’s risk adjustment to include a and the beneficiary population the RO adjustment. A commenter estimated that comprehensive set of major procedures participant has historically treated is if a beneficiary dies in the first 30 days not necessarily related to cancer. As appropriately captured. Recall that the of an episode, the TC payment for that noted in the proposed rule, we adopted national beneficiary profile is developed episode would be nearly $6,000 less this approach after consulting with from the same episodes used to than if the patient had survived. A clinical experts in radiation oncology. determine the Model’s national base

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rates, that is the updated 2016–2018 divided by the expected payment removing the historical experience episodes attributed to all HOPDs amounts, represents the net impact of adjustment, and adjusting the national nationally. The 2016–2018 episodes demographics, presence of base rates instead through a blend of a attributed to all HOPDs nationally are chemotherapy, presence of major participant’s historical experience with the reference point used for comparison procedures, and death rates on episode the national historical experience and to measure how much an RO payment amounts for that RO corresponding regional historical participant’s case mix should affect participant. experience. their respective episode payment The case mix adjustment will be One commenter requested that CMS amounts, precisely because the national updated for each RO participant provide the number and type of base rates are derived from those same annually, based on a three-year rolling providers and suppliers that are episodes. period of episodes attributed to the RO identified as historically efficient and participant that will be input into the We will develop a regression model as historically inefficient and how the case mix regression model. We cannot adjusted episode rates compare to the proposed that predicts Winsorized use the case mix of episodes during the episode payment amounts based on amount providers and suppliers would current PY, because this would prevent receive absent the Model. cancer type and demographic us from making a prospective payment. characteristics, presence of As for the suggestion that rather than Response: Our analyses show that chemotherapy, presence of major deriving the case mix adjustments from variation across regions of the country is procedures, and death rates, and we will a rolling three-year average, CMS should low, so we believe that a regional also finalize our approach to calculating implement a static baseline, we note historical experience adjustment is not the case mix adjustment as the that we use the same set of episodes to necessary. We identify what proportion difference between predicted and create the case mix coefficients as we of CCNs and TINs are historically expected payment, which is then did to generate the national base rates, efficient and what proportion are divided by expected payment. To so that the case mix adjustment properly historically inefficient based on the provide more clarification and simplify connects to the starting point of the updated 2016–2018 episode data, as the process for calculating the expected national base rates. We will include shown in Table 4. We do not want to payment for each RO participant, rather examples on the RO Model website that remove the historical experience than using average Winsorized episode demonstrate how the case mix and adjustments as this would cause an payments for each cancer type as historical experience adjustments are abrupt transition in payment proposed, we will develop a second calculated. determined largely or entirely by regression model that calculates Comment: Many commenters national base rate amounts. We are expected payment amounts based on expressed concern over the historical finalizing the case mix and historical cancer type alone. This will align the experience adjustments. A commenter experience adjustments as proposed use of regression models in the recommended that the historical with modification to a component part numerator and denominator of the case experience adjustment be removed of their calculation, the expected mix calculation. For a given RO entirely as the national base rates are payments as previously discussed in participant, the difference between disproportionately determined by the this section, and with modification to predicted episode payment amounts Winsorized historical payment, derive calculations based on episodes from the first regression model and preventing the adoption of a truly site from the same period, 2016–2018, used expected payment amounts from the neutral policy for radiation oncology. A to derive the national base rates, as second regression model, which is then few commenters also recommended appropriate.

Comment: A few commenters be removed for efficient practices. suppliers and penalize historically supported the proposed efficiency Several commenters including MedPAC efficient providers and suppliers, paying factor, stating that this will help stated that the historical experience them more and less than the base rate, practices as they transition into the adjustment as applied under the respectively. A commenter added that Model. Many commenters efficiency factor would reward the efficiency factor does not protect recommended that the efficiency factor historically inefficient providers and efficient participants from experiencing

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payment cuts under the Model. Several suggestions for the proposed efficiency furnished and 10 percent of the commenters disagreed with the factor. We believe that renaming the corresponding national base rate. This efficiency factor proposal on the efficiency factor as the ‘‘blend,’’ will will result in the historically efficient grounds that it would financially help clarify what it represents and call RO participant seeing an increase in penalize participants that appropriately attention to its purpose of setting the payment compared to historical treat beneficiaries who require more precise level of impact that the RO amounts prior to the discount and expensive or more frequent treatments. participant’s specific historical withholds being applied; for some of A few commenters suggested that experience has on the episode payment these participants, the payment amounts CMS should determine annually amounts. We calculate episode-based will be an increase under the Model whether a participant is efficient or not payments under the RO Model based on even with the discount and withholds based on more recent data, so that the average spend for each episode in all being applied. If we remove the participants that become efficient over HOPDs nationally. If RO participants efficiency factor for efficient providers the course of the Model are rewarded spent less historically (on average) than and suppliers, this would prevent the with an efficiency factor fixed at 0.90 the average spend of all HOPDs Model from maintaining costs or over the Model performance period. nationally, then their payment amount achieving savings. For instance, see Response: We thank these is 90 percent of what they would have Table 5 for an example of an efficient commenters for expressing both their been paid historically for the PC and/or RO participant in this section of this support and their concerns as well as TC of the respective cancer type final rule.

Similarly, if RO participants spent RO participant to gradually adjust to the payment would be higher than what more historically (on average) than the new model payments. An RO they would receive under FFS because average spend of all HOPDs nationally, participant that is categorized as the payment would be based on the then their payment amount begins at 95 historically inefficient, but becomes blend of the RO participant’s historical percent of what would have been paid more efficient over time, is rewarded payments and the national base rate, historically for the PC and/or TC of the under this Model design, specifically as both of which would be higher than respective cancer type furnished and 5 the blend is designed. These RO what they would receive under FFS percent of the corresponding national participants are privy to the sliding- during the model for less costly care. base rate. This will result in the scale blend factor where payment each See Table 6 for examples of inefficient historically inefficient RO participant PY is determined more and more by the RO participants in this section of this seeing a decrease in payment compared national base rates. If a historically final rule. to historical amounts, but the difference inefficient RO participant becomes more would be gradual over time to allow the efficient than the national average,

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We believe that historical payment is beneficiaries who require more payment is determined by the national the proper basis for comparison, and to expensive or more frequent treatments. base rates. The blend will be finalized this effect, historically efficient RO After considering the comments as proposed to be 90/10 in PY1, 85/15 participants will experience an increase received, we will finalize the case mix in PY2, 80/20 in PY3, 75/25 in PY4 and in payment. In contrast, historically adjustment with modification. The 70/30 in PY5. For those RO participants inefficient RO participants will formula that constitutes either the PC or with a PC or TC historical experience experience an incremental decrease in the TC case mix adjustment for an RO adjustment with a value equal to or less payment over the Model’s performance participant, that is the difference than zero (that is, historically efficient), period as the national base rates come between an RO participant’s predicted the blend will be finalized as proposed to account for incrementally more of the payment and an RO participant’s to be fixed at 90/10 over the Model’s payment outcomes. The RO Model is expected payment, divided by the performance period (PY1–PY5). expected payment, will not be modified. not designed to create equal rates for all (3) Proposal To Apply the Adjustments RO participants as the only way to do We modified the way in which we will this without significantly decreasing calculate the expected payments. For To apply the case mix adjustment, the some RO participants’ payments calculating the expected payment for historical experience adjustment, and compared to their historical would be to each RO participant, rather than using the efficiency factor (now referred to as average Winsorized episode payments pay all RO participants at the highest the blend) as discussed in section for each cancer type as proposed, we levels of any in the historical period. If III.C.6.e of the proposed rule (84 FR will use a second regression model that 34507 through 34509) and this final rule we were to do so, the RO Model would calculates expected payment amounts to the trended national base rates result in much higher spending during based on cancer type alone. its performance period than would detailed in Step 2, for the PC we After considering the comments occur absent the Model. Rather, the RO proposed to multiply: (a) The received, we will finalize the historical Model is designed to create participant- corresponding historical experience experience adjustment as proposed, and adjustment by (b) the corresponding specific professional and technical we will finalize the efficiency factor, episode payment amounts that draw RO efficiency factor, and then add (c) the henceforth called the ‘‘blend,’’ with corresponding case mix adjustment and participants as a group toward an modification. We refer readers to our average payment over time. In order to (d) the value of one. This formula regulation at § 512.255(d). For RO creates a combined adjustment that can soften the transition from a FFS participants with a PC or TC historical payment system to an episode-based be multiplied with the national base experience adjustment with a value rates. In the proposed rule, we one for RO participants, we designed a greater than zero (that is, historically expressed this mathematically as: pricing methodology that hews closely inefficient), the blend will be 90/10 in to historical payment amounts. Finally, PY1 where 90 percent of payment is Combined Adjustment = (Historical we believe the case mix and historical determined by the historical experience experience adjustment * Efficiency experience adjustments account for of the RO participant and 10 percent of factor) + Case mix adjustment + 1.0

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The combined adjustment would then would continue to equal the trended the no-pay HCPCS codes in the amount be multiplied by the corresponding national base rates in PY2. However, if participants would have been paid trended national base rate from Step 2 the RO participant had 60 or more absent the RO Model if it exceeds for each cancer type. We proposed to attributed episodes during the 2016– episode payments by a certain repeat these calculations for the 2018 period, then we proposed that the percentage and referenced CMS APMs corresponding case mix adjustment, RO participant’s participant-specific such as the BPCI Advanced Model, the historical experience adjustment, and professional episode payment and CJR Model, Medicare Shared Savings blend for the TC, yielding a total of 34 technical episode payment amounts for Program (MSSP), and OCM, which all RO participant-specific episode PY2 would equal the trended national cap downside risk. payments for Dual participants and a base rates with the case mix adjustment Response: We thank these total of 17 RO participant-specific added. In PY3–PY5, we proposed to commenters for their support and episode payments for Professional reevaluate those same RO participants suggestions. We refer readers to the low participants and Technical participants as we did in PY2 to determine the volume opt-out option in section (now 32 RO participant-specific episode number of episodes in the rolling three- III.C.3.c, which applies to those payments for Dual participants and a year period used in the case mix providers and suppliers that furnish total of 16 RO participant-specific adjustment for that performance year fewer than 20 episodes during the most episode payments for Professional (for example, PY3 will be 2017–2019). recent calendar year with claims data in participants and Technical participants RO participants that continue to have the CBSAs randomly selected for with the removal of kidney cancer). fewer than 60 attributed episodes in the participation. We agree with We proposed to use these case mix rolling three year period used in the commenters that if an RO participant adjustments, historical experience case mix adjustment for that has fewer than 60 episodes during the adjustments, and efficiency factors to performance year would continue to 2016–2018 period (rather than 2015– calculate the adjustments under the RO have participant-specific professional 2017 period), then the RO participant Model’s pricing methodology. episode payment and technical episode will not have a historical experience We received no comments on this payment amounts that equal the trended adjustment unless we find the need to proposal and, therefore, are finalizing national base rates, whereas those that rebaseline, which would require future this provision with only the have 60 or more attributed episodes rulemaking. Furthermore, if an RO modification that reflects the removal of would have participant-specific participant has fewer than 60 episodes kidney cancer. We are finalizing this professional episode payment and during the 2016–2018 period, then the provision with modification in that technical episode payment amounts that RO participant will not receive a case calculations for the corresponding case equal the trended national base rates mix adjustment for PY1. Therefore, we mix adjustment, historical experience with the case mix adjustment added. are finalizing our policy at adjustment, and blend for the PC and The following is a summary of the TC, yielding a total of 32 (not 34) RO § 512.255(c)(7) with the modification public comments we received on the that if an RO participant continues to participant-specific episode payments proposal related to RO participants with for Dual participants and a total of 16 have fewer than 60 episodes attributed fewer than 60 episodes during the 2015– to it during the 2017–2019 period, then (not 17) RO participant-specific episode 2017 period, and our responses to those the RO participant will not have a case payments for Professional participants comments. mix adjustment for PY2. However, if the and Technical participants. Comment: A few commenters expressed support for the proposal that RO participant has 60 or more attributed (4) Proposal for HOPD or Freestanding episodes during the 2017–2019 period Radiation Therapy Center With Fewer if an RO participant had fewer than 60 episodes during the 2015–2017 period, that had fewer than 60 episodes in both Than Sixty Episodes During 2015–2017 the 2016–2018 period, then the RO Period then that RO participant’s participant- specific professional episode payment participant will have a case mix In the proposed rule (84 FR 34508), and technical episode payment amounts adjustment for PY2 and the remaining we proposed that if an HOPD or would equal the trended national base PYs of the Model. In PY3–PY5, we will freestanding radiation therapy center rates. These commenters supported this reevaluate those same RO participants (identified by a CCN or TIN) furnished gradual approach to establishing that did not receive a case mix RT services during the Model payment rates for low volume adjustment the previous PY to performance period within a CBSA participants that are typically small or determine the number of episodes in the selected for participation and was new practices that are likely to rolling three-year period used in the required to participate in the Model gradually ramp up services over the life case mix adjustment for that because it meets eligibility of the Model. performance year (for example, PY3 will requirements, but had fewer than 60 Several commenters recommended be 2018–2020). Please see Table 10 that episodes attributed to it during the CMS exclude providers and suppliers summarizes data sources and time 2015–2017 period, then the RO with fewer than 60 episodes during the periods used to determine the values of participant’s participant-specific 2015–2017 period, rather than just key pricing components. professional episode payment and making adjustments to their episode We also agree with commenters technical episode payment amounts payments. Another commenter noted regarding their concerns for RO would equal the trended national base that for participants without historical participants without historical rates in PY1. In PY2, if an RO experience, the reduction in payment, experiences and the payment reduction participant with fewer than 60 episodes particularly for those delivering PBT, that would result in the absence of a attributed to it during the 2015–2017 would be immediate and could be as historical experience. In response to period continued to have fewer than 60 high as 50 percent. Several commenters comments, we are including a stop-loss episodes attributed to it during the proposed that a stop-loss policy be limit of 20 percent for the RO 2016–2018 period, then we proposed added to protect those participants at participants that have fewer than 60 that the RO participant’s participant- risk for significant loss. A few of those episodes during the baseline period and specific professional episode payment commenters suggested that CMS pay were furnishing included RT services in and technical episode payment amounts participants amounts that correspond to the CBSAs selected for participation at

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the time of the effective date of this final provision would apply to a new TIN or Several commenters stated that the rule. CCN that results from a merger, discount factors create an un-level Using no-pay claims to determine acquisition, or other new clinical or playing field between RO participants what these RO participants would have business relationship that occurs prior and non-participants. A commenter been paid under FFS as compared to the to October 3, 2025 (changed from questioned the validity of using private payments they received under the October 3, 2024). payer models as a guide to setting Model, CMS will pay these RO discount factor amounts in a Medicare participants retrospectively for losses in f. Applying a Discount Factor model, given the meaningful differences excess of 20 percent of what they would After applying participant-specific in rate structures. A few commenters have been paid under FFS. Payments adjustments under section III.C.6.e of requested that a rationale be given as to under the stop-loss policy are the proposed rule to the trended why the discount factor for the TC is determined at the time of reconciliation. national base rates, we proposed, at 84 higher than that of the PC. We are finalizing this stop-loss policy FR 34509, to next deduct a percentage Response: We thank these at § 512.255(b)(7). discount from those amounts for each commenters for expressing their (5) Apply Adjustments for HOPD or performance year. The discount factor concerns and for their suggestions. We Freestanding Radiation Therapy Center would not vary by cancer type. We designed the RO Model to test whether With a Merger, Acquisition, or Other proposed that the discount factor for the prospective episode payments in lieu of New Clinical or Business Relationship, PC be 4 percent and the discount factor traditional FFS payments for RT With or Without a CCN or TIN Change for the TC be 5 percent. We proposed to services would reduce Medicare use the 4 and 5 percent discounts based expenditures while preserving or We proposed that a new TIN or CCN on discounts in other models tested enhancing quality. We believe that that results from a merger, acquisition, under section 1115A and private payer reducing the discount factors to 3.75 or other new clinical or business models. We believed these figures for percent and 4.75 percent for the PC and relationship that occurs prior to October the discount factor, 4 and 5 percent for TC, respectively, balances the need for 3, 2024, meets the Model’s proposed the PC and TC, respectively, struck an the Model to achieve savings while also eligibility requirements discussed in appropriate balance in creating savings reducing the impact on payment to RO section III.C.3 of the proposed rule and participants as initially proposed. The this final rule. If the new TIN or CCN for Medicare while not creating substantial financial burden on RO level of discounts is based on actuarial begins to furnish RT services within a projections for how the Model as a CBSA selected for participation, then it participants with respect to reduction in payment. whole will impact Medicare payments; must participate in the Model. We the level of discounts is not based on proposed this policy in order to prevent We proposed to apply these discount factors to the RO participant-adjusted the percentage rate of the APM HOPDs and freestanding radiation Incentive Payments. We believe that RO and trended payment amounts for each therapy centers from engaging in participants will benefit from their of the RO Model’s performance years. mergers, acquisitions, or other new participation in this alternative payment The following is a summary of the clinical or business relationships so as model, and we disagree that the Model public comments received on this to avoid participating in the Model. will create an un-level playing field proposal to apply a discount factor and We proposed for the RO Model to between RO participants and non- our responses to those comments: require advanced notification so that the participants. Also, given that the 2 appropriate adjustments are made to the Comment: Many commenters percent quality withhold applies to the new or existing RO participant’s suggested reducing the discount factors PC whereas the TC will have a 1 percent participant-specific professional episode for both the PC and TC down within the patient experience withhold beginning payment and participant-specific 1 and 3 percent range or phasing in the in PY3 (see section III.C.6.g), we believe technical episode payment amounts. percentage of the discount factor over that the PC should have a lower This requirement for the RO Model is several PYs. These commenters cited discount factor than the TC. the same requirement as at § 512.180(c) the BPCI Advanced Model, the CJR We are finalizing this provision with of the proposed rule, except that under Model, and the proposed Episode modification in section III.C.6.f in that the RO Model, RO participants must Payment Model along with the the discount factors for the PC and TC also provide a notification regarding a downside track of the OCM, all of which will each be reduced by 0.25 percent. new clinical relationship that may or had lower discount factors than what is The discount factor for the PC will be may not constitute a change in control. currently proposed for the RO Model. 3.75 percent. The discount factor for the If there is sufficient historical data from Many commenters expressed TC will be 4.75 percent. Additionally, the entities merged, absorbed, or particular concern about the discount we are modifying the regulatory text at otherwise changed as a result of this factor related to the TC. A few suggested § 512.205 to specify the Discount factor new clinical or business relationship, that RO participants should receive a 5 means the set percentage by which CMS then this data would be used to percent incentive payment based on reduces payment of the PC and TC. The determine adjustments for the new or both the PC and TC as part of their APM reduction on payment occurs after the existing TIN or CCN. For our policy Incentive Payment. Alternatively, if trend factor and model-specific regarding change in legal name and there is no opportunity to include the adjustments have been applied but change in control provisions, we refer TC payments in calculating the 5 before beneficiary cost-sharing and readers to discussion at 84 FR 34489 of percent APM Incentive Payment, then standard CMS adjustments, including the proposed rule and in section II.L the commenters recommended that the geographic practice cost index this final rule and our regulations at there should be no discount factor for (GPCI) and sequestration, have been § 512.180(b) and (c). the TC. These commenters explained applied. We received no comments on this that RO participants rely on technical proposal. We are finalizing our proposal payments to invest in technologies, g. Applying Withholds at § 512.255(b)(5), with modification to which can increase the value of care and We proposed to withhold a align with the finalized Model decrease the long-term toxicity of RT percentage of the total episode performance period so that this services. payments, that is the payment amounts

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after the trend factor, adjustments, and which specifies the RO participant’s percent patient experience withhold a discount factor have been applied to the reconciliation payment amount or participant will receive back. national base rates, to address payment repayment amount. Further, we We proposed the incorrect payment issues and to create incentives for proposed to codify the term withhold, the quality withhold, and the furnishing high quality, patient-centered ‘‘reconciliation report’’ at § 512.205. patient experience withhold be care. We outlined our proposals for included in the RO Model’s pricing three withhold policies in section (2) Quality Withhold methodology. The following is a III.C.6.g of the proposed rule and in this We proposed to also apply a 2 percent summary of the public comments we section of this final rule. quality withhold for the PC to the received on this proposal and our responses to those comments: (1) Incorrect Payment Withhold applicable trended national base rates after the case mix and historical Comment: Many commenters We proposed to withhold 2 percent of experience adjustments and discount expressed concerns with the incorrect the total episode payments for both the factor have been applied. This would payment withhold, the quality PC and TC of each cancer type. This 2 allow the Model to include quality withhold, and the patient experience percent would reserve money to address measure results as a factor when withhold and the financial burden that overpayments that may result from two determining payment to participants these withholds could pose for RO situations: (1) Duplicate RT services as under the terms of the APM, which is participants. A few commenters discussed in section III.C.6.a of the one of the Advanced APM criteria as requested that CMS explain the proposed rule; and (2) incomplete codified in 42 CFR 414.1415(b)(1). rationale for the withholds over other episodes as discussed in section III.C.6.a Professional participants and Dual means of accounting for patient of the proposed rule. participants would be able to earn back experience and quality in the Model. A We proposed a withhold for these two up to the 2 percent withhold amount few commenters stated that the circumstances in order to decrease the each performance year based on their withholds are punitive in nature as they likelihood of CMS needing to recoup aggregate quality score (AQS). We occur prior to the delivery of services. payment, which could cause proposed to define the term ‘‘AQS’’ to A commenter noted that the funds administrative burden on CMS and mean the numeric score calculated for withheld, which are eventually paid to potentially disrupt an RO participant’s each RO participant based on its the participant through the cash flow. We believe that a 2 percent performance on, and reporting of, reconciliation process, are not subject to incorrect payment withhold would set coinsurance collection from quality measures and clinical data, as aside sufficient funds to capture an RO beneficiaries or from beneficiaries’ described in section III.C.8.f of the participant’s duplicate RT services and supplemental insurance. A commenter proposed rule, which is used to incomplete episodes during the stated that withholds applied to the TC determine an RO participant’s quality reconciliation process. In the proposed in particular will make it difficult to reconciliation payment amount. We rule, we stated that we anticipate that keep up with debt service. duplicate RT services requiring proposed to codify this definition at Several commenters expressed reconciliation will be uncommon, and § 512.205 of our regulations. We concern over the incorrect payment that few overpayments for such services proposed that the annual reconciliation withhold in particular. A few will therefore be subject to our process described in section III.C.11 of commenters suggested eliminating the reconciliation process. Claims data from the proposed rule would determine how incorrect payment withhold. A January 1, 2014 through December 31, much of the 2 percent withhold a commenter called attention to the CMS 2016 show less than 6 percent of Professional participant or Dual claim that it is uncommon that a RT episodes had more than one unique TIN participant would receive back. provider or RT supplier does not furnish or CCN billing for either professional RT (3) Patient Experience Withhold a technical component RT service to a services or technical RT services within beneficiary within 28 days of when the a single episode. Similarly, our analysis We proposed to apply a 1 percent radiation oncologist furnishes an RT showed that it is uncommon that a RT withhold for the TC to the applicable treatment planning service to such RO provider or RT supplier does not furnish trended national base rates after the case beneficiary, and that, therefore, the a technical component RT service to a mix and historical experience additional cash flow burden the beneficiary within 28 days of when a adjustments and discount factor have incorrect episode withhold would place radiation oncologist furnishes an RT been applied starting in PY3 (January 1, on RO participants is not warranted. A treatment planning service to such RO 2022 through December 31, 2022) to commenter suggested recouping funds beneficiary. account for patient experience in the from participants for duplicate services We proposed to use the annual Model. Under this proposal, Technical and incomplete episodes in the reconciliation process described in participants and Dual participants subsequent performance year rather section III.C.11 of this final rule to would be able to earn back up to the full than implementing a withhold structure determine whether an RO participant is amount of the patient experience to prospectively account for those eligible to receive back the full 2 percent withhold for a given PY based on their funds. The commenter argued that this withhold amount, a portion of it, or results from the patient-reported would reduce RO participants’ financial must repay funds to CMS. We proposed Consumer Assessment of Healthcare exposure. to define the term ‘‘repayment amount’’ Providers and Systems (CAHPS®) One commenter specifically to mean the amount owed by an RO Cancer Care Survey for Radiation addressed the patient experience participant to CMS, as reflected on a Therapy (CAHPS® Cancer Care survey) withhold. This commenter disagreed reconciliation report. We proposed to as discussed in section III.C.8.b of the with the 1 percent patient experience codify the term ‘‘repayment amount’’ at proposed rule. withhold starting in PY3, stating that § 512.205 of our regulations. In addition, Like the incorrect payment and patient experience surveys that are we proposed to define the term quality withholds, the initial mailed out have varying response rates, ‘‘reconciliation report’’ to mean the reconciliation process discussed in do not adequately capture performance, annual report issued by CMS to an RO section III.C.11 of the proposed rule and as such the 1 percent patient participant for each performance year, would determine how much of the 1 experience withhold is unreasonable.

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This commenter argued that the patient h. Adjustment for Geography (Work, PE, and MP) that make up the experience surveys should only serve as As noted in the proposed rule, value of the RO Model-specific RVUs. supplemental data collection. geographic adjustments are standard Existing radiation oncology HCPCS Response: We thank these Medicare adjustments that occur in the codes that are included in the bundled commenters for expressing their claims system. Even though the Model RO Model codes but paid only through concerns and for their suggestions. will establish a common payment the OPPS would not be included in the Although we expect incomplete amount for the same RT services calculation. The RVU shares would be episodes and duplicate payments to be regardless of where they are furnished, calculated as the volume-weighted uncommon, we believe that the burden payment will still be processed through Work, PE, and MP shares of each of recoupment (if we were to not do a the current claims systems, with included existing HCPCS code’s total withhold) would outweigh the burden adjustments as discussed in section RVUs in the PFS. The PCs and TCs for of withholding funds until annual III.C.7 of the proposed and this final the RO episodes would have different reconciliation for those RO episodes RO Model-specific RVU shares, but rule, for OPPS and PFS. We proposed that require reconciliation. these shares would not vary by cancer that geographic adjustments would be Yet, given stakeholders’ concerns type. Table 4 of the proposed rule (at 84 calculated within those shared systems regarding the cash flow burden that the FR 34510) provided the proposed after CMS submits RO Model payment withholds may cause and given that relative weight of each for the PCs and files to the Medicare Administrative funds withheld are not subject to TCs of the RO Model-specific RVUs Contractors that contain RO participant- coinsurance collection from share. beneficiaries or from beneficiaries’ specific calculations of payment from We indicated in the proposed rule supplemental insurance, we are steps (a) through (g). We proposed to that we would include these RO Model- finalizing a reduced incorrect payment adjust the trended national base rates specific RVUs in the same process that withhold of 1 percent rather than 2 that have been adjusted for each RO calculates geographically adjusted percent. The reduction of this withhold participant’s case mix, historical payment amounts for other HCPCS will also ease the burden of keeping up experience and after which the discount codes under the PFS with Work, PE, and with debt service as a commenter noted. factor and withholds have been applied, MP and their respective RVU value We believe that the upfront quality for local cost and wage indices based on applied to each RO Model HCPCS code. withhold will provide the incentive for where RT services are furnished, We proposed to apply the OPPS RO participants to provide high-quality pursuant to existing geographic Pricer as is automatically applied under care. Further, we believe that the adjustment processes in the OPPS and OPPS outside of the Model. We predetermined withholds help support PFS. proposed to use RO Model-specific RVU the Model goal of providing RO OPPS automatically applies a wage shares to apply PFS RVU components participants with prospective, index adjustment based on the current (Work, PE, and MP) to the new RO predictable payments. As for year post-reclassification hospital wage Model payment amounts in the same effectiveness of the patient experience index to 60 percent (the labor-related way they are used to adjust payments surveys, we refer commenters to section share) of the OPPS payment rate. We for PFS services. See RVU shares in III.C.8, where quality measures are stated in the proposed rule that no Table 7. discussed in detail. We note that we additional changes to the OPPS Pricer The following is a summary of the would propose specific benchmarks for are needed to ensure geographic public comments we received on the the patient experience measures in adjustment. proposal to adjust for geography, and future rule-making. The PFS geographic adjustment has our responses to those comments: After considering public comments, three components that are applied Comment: A few commenters stated we are finalizing our proposals on separately to the three RVU components that all components of the pricing incorrect payment withhold, quality that underlie the PFS—Work, PE and methodology should be based on withhold, and patient experience MP. To calculate a locality-adjusted geographically standardized payments withhold, with modifications. We are payment rate for the RO participants as it would be inappropriate for CMS to finalizing the quality withhold amounts paid under PFS, we proposed to create compare geographically-adjusted as proposed beginning in PY1 (January a set of RO Model-specific RVUs using historical payments with non- 1, 2021, through December 31, 2021) the national (unadjusted) payment rates geographically-adjusted predicted and the patient experience withhold as for each HCPCS code of the included RT payments. A couple of commenters proposed beginning in PY3 (January 1, services for each cancer type included stated that the adjustment for geography 2023 through December 31, 2023), but in the RO Model. First, the trended was unnecessary or inappropriate. A we will reduce the incorrect payment national base rates for the PC and TC commenter explained that the withhold to 1 percent beginning in PY1. would be divided by the PFS conversion geographic adjustment was Based on the concerns raised by factor (CF) for the upcoming year to inappropriate, because the national commenters, we intend to reevaluate create an RO Model-specific RVU value market determines competition and this amount and need for the incorrect for the PC and TC payment amounts. purchase price in the field of radiation payment withhold in PY3. Additionally, Next, since the PFS geographic oncology. Another commenter agreed we have modified the text of the adjustments are applied separately to that the adjustment was unnecessary, regulation at § 512.255(h), (i), and (j) to the three RVU components (Work, PE, but explained that it was unnecessary describe how incorrect payment and MP), these RO Model-specific RVUs not because of the national market withhold, quality withhold, and patient would be split into RO Model-specific argument, but because the national base experience withhold would be applied Work, PE, and MP RVUs. The 2015– rates are set using 2015–2017 claims to the national base rates, in a manner 2017 episodes that had the majority of data to which the GPCI had already consistent with the regulatory text for radiation treatment services furnished at been applied. how other adjustments (for example, the an HOPD and that were attributed to an Response: We thank these discount factor and geographic HOPD would be used to calculate the commenters for these suggestions. We adjustment) are applied to the national implied RVU shares, or the proportional would like to clarify that we construct base rate. weights of each of the three components and calculate the payment amounts for

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the PC and TC of each episode as the that are without geographic adjustment. geographic adjustment with product of: (a) The OPPS or PFS As previously stated, this method of modification to clarify that although the national payment rates for each of the geographic adjustment is the standard RO Model-specific RVU values are RT services included in the Model way we pay through PFS and OPPS, and derived from the national base rates multiplied by (b) the volume of each we want to recognize differences in which we are finalizing to be based on professional or technical RT service payment based on geographic area. We 2016–2018 episodes that had the included on a paid claim line during have no way of determining whether the majority of radiation treatment services each episode. Episode payments under national market determines competition furnished at an HOPD and that were the Model are standardized in the sense or purchase price in the field of attributed to an HOPD, we will use only radiation oncology, as a commenter that their basis is service volume and 2018 episodes to calculate the implied suggested. Importantly, we want to national fee schedule prices. Moreover, RVU shares, or the proportional weights design episode payments in such a way the calculations that determine the that they could be implemented on a of each of the three components (Work, trend factors as well as the case mix and broader scale, if the Model is successful. PE, and MP). These RVU shares are part historical experience adjustments are After considering public comments, of the calculus determining the RO based on these standardized payments we are finalizing our proposal on the Model-specific RVU values.

i. Applying Coinsurance as it would preserve the incentive to use proposed rule that we would encourage We proposed to calculate the more fractions and certain modality RO participants to collect coinsurance coinsurance amount for an RO types so that a higher payment amount for services furnished under the RO beneficiary after applying, as could be achieved. Model in multiple installments via a appropriate, the case mix and historical In the proposed rule, we noted that, payment plan (provided the RO experience adjustments, withholds, depending on the choice of modality participants would inform patients of discount factors, and geographic and number of fractions administered the installment plan’s availability only adjustments to the trended national base by the RO participant during the course during the course of the actual billing rates for the cancer type billed by the of treatment, the coinsurance payment process). RO participant for the RO beneficiary’s amount of the bundled rate may In addition, for the TC, we proposed treatment. Under current policy, occasionally be higher than what a to continue to apply the limit on Medicare FFS beneficiaries are generally beneficiary or secondary insurer would beneficiary liability for copayment for a required to pay 20 percent of the otherwise pay under Medicare FFS. procedure (as described in in section allowed charge for services furnished by However, because the PC and TC would 1833(t)(8)(C)(i) of the Act) to the HOPDs and physicians (for example, be subject to withholds and discounts applicable trended national base rates those services paid for under the OPPS described in the previous section, we after the case mix and historical and PFS, respectively). We proposed stated in the proposed rule that we experience adjustments, discount factor, that this policy remain the same under believed that, on average, the total applicable withholds, and geographic the RO Model. RO beneficiaries will pay coinsurance paid by RO beneficiaries adjustment have been applied. 20 percent of each of the bundled PC would be lower than what they would We solicited public comment on our and TC payments for their cancer type, have paid under Medicare FFS for all of proposal to apply the standard regardless of what their total the services included in an RO episode. coinsurance of 20 percent to the trended coinsurance payment amount would In other words, the withholds and national base rates for the cancer type have been under the FFS payment discount factors would, on average, be billed by the RO participant for the RO system. expected to reduce the total amount RO beneficiary’s treatment after the case In the proposed rule (84 FR 34510 beneficiaries or secondary insurers will mix and historical experience through 34511), we stated that owe RO participants. adjustments, withholds, discount maintaining the 20 percent coinsurance In the proposed rule, we also factors, and geographic adjustments payment would help preserve the explained that because episode payment have been applied. integrity of the Model test and the goals amounts under the RO Model would The following is a summary of the guiding its policies. Adopting an include payments for RT services that public comments received on this alternative coinsurance policy that would likely be provided over multiple proposal and our responses: would maintain the coinsurance that visits, the beneficiary coinsurance Comment: Many commenters would apply in the absence in the payment for each of the episode’s requested clarification as to the role of Model, where volume and modality payment amounts would consequently secondary payers, MediGap, and type would dictate coinsurance be higher than it would otherwise be for Medicaid and whether secondary payers amounts, would change the overall a single RT service visit. For RO would be held accountable if the RO payment that RO participants would beneficiaries who do not have a episode is not allowed and payment is receive. This would skew Model results secondary insurer, we stated in the recouped. A commenter requested

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clarification as to whether CMS would beneficiaries would be confused by 20 treatment after receiving a single provide information to insurance percent of episode payment as 20 radiation treatment. entities that receive crossover or percent is the standard coinsurance Response: We thank these secondary claims under the Model. A policy under Medicare. Although we commenters for expressing their commenter recommended that CMS encourage RO participants to implement concerns and for their suggestions. follow current Coordination of Benefits payment plans for RO beneficiaries, Although a beneficiary’s coinsurance rules and transmit no-pay claims for RT neither the proposed rule nor the final obligation under most RO episodes may services under the RO Model as ‘‘paid’’ rule requires RO participants to not be the same as it would be under to supplemental insurers for secondary implement payment plans. At this time, Medicare FFS, we believe that, on payment under FFS. we are not providing specific guidance average, the total coinsurance paid by Response: We appreciate the on creating payment plans because we RO beneficiaries would be lower than commenters concerns. CMS liaisons to believe that RO participants who choose what they would have paid under the secondary payers will provide RO to implement a payment plan for Medicare FFS for all of the services Model-specific information to those included in an RO episode. The average beneficiaries should have the flexibility payers including how the RO Model- payment amounts from which the 20 to create one that meets their needs. We specific HCPCS shall be processed. percent of coinsurance is determined is agree with the commenter that patients Current Coordination of Benefits rules reduced by both the discount factor and shall continue to apply. As noted in the should be informed of the availability of the withholds. There may be cases proposed rule, we expect to provide RO the payment plan before they receive where the beneficiary coinsurance is participants with additional instructions services under the RO Model. However, slightly higher than what the RO for billing, particularly as it pertains to the availability of payment plans may beneficiary would have owed under secondary payers and collecting not be used as a marketing tool to FFS. Yet, for a bundled payment beneficiary coinsurance. Additional influence beneficiary choice of health approach that moves away from FFS instructions will be made available care provider. Accordingly, we are volume-based incentives to payment through the Medicare Learning Network finalizing at § 512.255(b)(12) a provision based on the average cost of care, this (MLN Matters) publications, model- that (1) permits RO participants to is unavoidable. This would present a specific webinars, and the RO Model collect beneficiary coinsurance payment issue in that either CMS or the website. payments for services furnished under RO participant may need to absorb any Comment: A few commenters the RO Model in multiple installments potential reduction in episode payment. expressed concern that the Model’s via a payment plan, (2) prohibits RO Furthermore, we did not propose to base policy of imposing a 20 percent participants from using the availability beneficiary coinsurance on no-pay FFS coinsurance payment on the episode of payment plans as a marketing tool to claims because, if we did so, then a payment amount will be confusing to influence beneficiary choice of health significant portion of the payments that beneficiaries. Some commenters care provider, and (3) provides that an an RO participant received under the requested specific guidance on creating RO participant offering such a payment Model would be premised on FFS a payment plan for beneficiaries and plan may inform the beneficiary of the payment and be subject to the usual FFS expressed concern that participants will availability of the payment plan prior to volume-based incentives. To avoid not have the billing staff to implement or during the initial treatment planning compromising the integrity of the Model payment plans for beneficiaries. A few session and as necessary thereafter. test in this way, we are not waiving the commenters disagreed with CMS’ Comment: Several commenters 20 percent beneficiary coinsurance proposal to encourage RO participants expressed concerns that beneficiaries requirement based on the beneficiary to implement payment plans for who receive fewer or lower-cost RT receiving a limited number of RT beneficiaries but to restrict RO services than average for their cancer services, such as one RT service. participants’ ability to inform patients of However, we are not finalizing our type would pay more in cost-sharing in the payment plan’s availability to the coinsurance proposal with respect to a a participating region than if they had time of the actual billing process. Those subset of incomplete episodes, commenters argue that this delay, received the same treatment in a non- specifically those in which: (1) The TC waiting until the course of the actual participating region. A commenter is not initiated within 28 days following billing process, conflicts with CMS’ noted that although many patients have the PC; (2) the RO beneficiary ceases to price transparency proposal that supplemental insurance that will shield have traditional FFS Medicare prior to patients know their financial them from higher cost-sharing amounts, the date upon which a TC is initiated, responsibilities prior to receiving some beneficiaries may be financially even if that date is within 28 days services. A few commenters added that harmed by this approach. A few following the PC; or (3) the RO CMS should not dictate when this commenters suggested CMS set beneficiary switches RT provider or RT discussion occurs. A commenter beneficiary cost-sharing at the lesser of supplier before all RT services in the RO requested clarification as to whether (a) what the beneficiary would have episode have been furnished. uncollected beneficiary coinsurance paid in cost-sharing under Medicare Thus, the beneficiaries who receive under the RO Model remains subject to FFS payment amounts for the specific RT services in this subset of incomplete additional payment under the Medicare services the patient received, or (b) 20 episodes would pay the coinsurance bad debt provision. percent of the bundled payment amount of 20 percent of the FFS Response: It is important to note that amount. Several commenters suggested amounts for those services. We note that RO participants should expect to receive that CMS should base beneficiary RO participants that set up coinsurance beneficiary coinsurance in the same coinsurance on no-pay FFS claims for payment plans may be able to charge manner as they do for FFS. All the services provided during an RO episode. and adjust coinsurance more timely and standard rules and regulations under A commenter suggested removing the accurately for incomplete episodes; but FFS pertaining to beneficiary requirement of beneficiary coinsurance in some circumstances the true amount coinsurance apply under the RO Model, of 20 percent on each of the episode’s owed by the beneficiary may not be including the Medicare bad debt payment amounts in a specific instance, determined until the reconciliation provision. We do not believe that such as when a beneficiary ends process has occurred.

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In instances where an RO beneficiary episode in which (1) the TC is not sequence, prior to the case mix and ceases to have traditional FFS Medicare initiated within 28 days following the historical experience adjustments, as his or her primary payer at any time PC, (2) the RO beneficiary ceases to have discount factor and withholds. Second, after the initial treatment planning traditional FFS Medicare prior to the the withhold calculation properly service is furnished and before the date date upon which a TC is initiated, even accounts for 1 percent for the incorrect of service on a claim with an RO Model- if that date is within 28 days following payment withhold and 2 percent for the specific HCPCS code and EOE modifier, the PC, or (3) the RO beneficiary quality withhold for the professional provided that a Technical participant or switches RT provider or RT supplier component. The corresponding the same Dual participant furnishes a before all RT services in the RO episode proposed rule table, Table 5, incorrectly technical component RT service to the have been furnished. had the withholds multiplied together, RO beneficiary within 28 days of such j. Example of Participant-Specific resulting in slightly lower withheld initial treatment planning service, the Professional Episode Payment and amounts. Third, the discount factor and RO beneficiary would pay 20 percent of Participant-Specific Technical Episode withholds now display the percentage the first installment of the RO episode. Payment for an Episode Involving Lung of reduction as finalized, rather than the However, if the RO participant bills the Cancer in PY1 inverse of those percentages as was Model-specific HCPCS code and EOE shown in the proposed rule at Tables 5 modifier with a date of service that is Table 8 and Table 9 illustrate possible and 6. participant-specific professional and prior to the date that the RO beneficiary Finally, Tables 8 and 9 properly technical episode payments paid by ceases to have traditional FFS Medicare, reflect the way in which the claims then the beneficiary coinsurance CMS to one entity (Dual participant) or two entities (Professional participant systems split total payment between payment equals 20 percent of the full and Technical participant) for the SOE and EOE payments. The claims episode payment amount for the PC or furnishing of RT professional services systems begin with half the trended TC, as applicable. Because these and RT technical services to an RO national base rate amount that policies would only apply to a relatively beneficiary for an RO episode of lung corresponds with the RO Model-specific small number of RO episodes, we do not cancer. Table 8 and Table 9 are updated HCPCS code listed on the claim believe that it would be unduly versions of Table 5 and Table 6 of the submitted by the RO participant for the burdensome for RO participants to proposed rule, respectively, that reflect cancer type and component administer or affect the integrity of the policies described in section III.C.5. of (professional or technical) billed. The Model test and the goals guiding its this final rule. Table 5 and Table 6 are claims systems then apply the policies. displayed in the proposed rule at 84 FR appropriate adjustments, discount We are finalizing, in part, our 34511 and 34512. Tables 8 and 9 also factor, and withholds to that amount. proposal related to coinsurance. reflect the following technical changes: Tables 8 and 9 reflect this by splitting Specifically, we are codifying at (1) The change in sequence related to payment at the offset (see Tables 8 and 512.255(b)(12) the requirement that RO the geographic adjustment discussed in 9, row (d)) rather than at the end, as the participants offering a payment plan section III.C.6.h. of this final rule; (2) a proposed rule example has displayed may not use the availability of the change in the way the withhold (see rows (s) and (t) in Table 5 at 84 FR payment plan as a marketing tool and calculation is displayed in the proposed 34511 and Table 6 at 84 FR 3512). may inform the beneficiary of the rule example; (3) a change in the way Please note that Table 8, which availability of the payment plan prior to discount factor and withholds are displays the participant-specific or during the initial treatment planning displayed in the proposed rule example; professional episode payment example session and as necessary thereafter. and (4) a change in the way the total does not include any withhold amount With respect to a subset of incomplete episode payment amount is split that the RO participant would be episodes, we are not finalizing our between the SOE payment and EOE eligible to receive back or repayment if proposal that beneficiaries pay 20 payment. As a result of these technical more money was needed beyond the percent of the episode payment. changes, Tables 8 and 9 properly reflect withhold amount from the RO Accordingly, the beneficiary will owe the way in which the claims systems participant. It also does not include any 20 percent of the FFS amount for RT process payment. First, the geographic MIPS adjustment that applies to the RO services furnished during an incomplete adjustment comes in the proper participant.

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Table 9 details the participant-specific lung cancer. The participant-specific receive. Also, please note that for the technical episode payment paid by CMS technical episode payment in this participant-specific technical payment to a single TIN or single CCN for the example does not include any rural sole amount, the beneficiary coinsurance furnishing of RT technical services to an community hospital adjustment that the cannot exceed the inpatient deductible RO beneficiary for an RO episode of RO participant would be eligible to limit under OPPS.

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After considering public comments on (4) Apply a stop-loss limit of 20 geographic adjustment to the trended our proposed pricing methodology, as percent for the RO participants that national base rates prior to the case mix previously summarized, we are have fewer than 60 episodes during and historical experience adjustments finalizing the pricing methodology as 2016–2018 and that were furnishing and prior to the discount factor and proposed with the following included RT services in the CBSAs withholds. selected for participation at the time of modifications. We are also providing (3) Update the years used in the trend the effective date of this final rule. Table 10, which summarizes the data factor’s numerator and denominator sources and time periods used to We are also making the following calculation. For the trend factor’s modifications, which are not being determine the values of key pricing numerator calculation, the most recent codified in regulation text, to our components as a result of these calendar year with complete data used pricing methodology policy: modifications. to determine the average number of (1) Change the baseline from which (1) Change the name of the ‘‘efficiency times each HCPCS code was furnished the national base rates, Winsorization factor’’ of the historical experience will be 2018 for PY1, 2019 for PY2, and thresholds, case mix coefficients, case adjustment to ‘‘blend.’’ so forth. The trend factor’s denominator mix values, and historical experience (2) Reduce the discount rate of the PC adjustments are derived from 2015– calculation will use data from 2018 to and TC from 4 and 5 percent to 3.75 and 2017 to 2016–2018. determine (a) the average number of times each HCPCS code (relevant to the 4.75 percent, respectively. (2) Change the sequence of the (3) Reduce the incorrect payment proposed eight primary steps to the component and the cancer type for withhold from 2 percent to 1 percent. pricing methodology, that is apply the which the trend factor will be applying)

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was furnished and (b) the corresponding Winsorized baseline expenditures by (8) Update the episodes used to FFS payment rate. cancer type). determine the RVU shares of the PFS (4) Update the years used to (6) Update the years used to geographic adjustment from 2015–2017 determine the case mix values, determine whether an HOPD or episodes to 2018 episodes. freestanding radiation therapy center beginning with 2016–2018 for PY1, has fewer than sixty episodes, making Please note that we will review 2017–2019 for PY2, and so on. them ineligible to receive a historical utilization data in non-RO participants’ (5) Align the approach to deriving experience adjustment, from 2015–2017 2020 episodes to assess the impact of expected payment amounts for each to 2016–2018 to mirror the change in the PHE on RT treatment patterns and episode in the case mix adjustment with baseline noted in (1). whether an alternative method is how the predicted payment amounts are (7) Update the years used to needed to determine the trend factor for calculated by using regression models determine whether an HOPD or PY3 to prevent the PY3 trend factor for both calculations; for the expected freestanding radiation therapy center from being artificially low or high due payment amounts, the regression model has fewer than sixty episodes, making to the PHE. If we find an alternative would be a simple one that contains them ineligible to receive case mix method is necessary, we will propose cancer type only on the right hand side adjustment, beginning with 2016–2018 this in future rulemaking. rather than using the average for PY1, 2017–2019 for PY2, and so on.

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7. Professional and Technical Billing components as identified in the CMS PC and the TC, to allow for use of and Payment National PFS Relative Value File, we current claims systems for PFS and proposed that all RO Model episodes OPPS to be used to adjudicate RO Similar to the way many procedure would be split into two components, the Model claims. As stated in the proposed codes have professional and technical

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rule, we believe that the best design for services provided by the physician personnel, and costs related to the a prospective episode payment system during the episode. As stated in the radiation treatment during the episode. for RT services would be to pay the full proposed rule, payment for the PC We proposed that the TC of the participant-specific professional and would be made through the PFS and episode would begin on or after the date technical episode payment amounts in would only be paid to physician group that the PC of the episode is initiated two installments. We believe that two practices (as identified by their and that it would last until the PC of the payments reduce the amount of money respective TINs). episode concludes. Accordingly, the that may need to be recouped due to Under our proposed billing policy, a portion of the episode during which the incomplete episodes and the likelihood Professional participant or Dual TC is furnished may be up to 90 days that the limit on beneficiary liability for participant that furnishes the PC of the long, but could be shorter due to the copayment for a procedure provided in episode would be required to bill one of time between when the treatment an HOPD (as described in section the new RO Model-specific HCPCS planning service is furnished to the RO 1833(t)(8)(C)(i) of the Act) is met. codes and an SOE modifier. As stated in beneficiary and when RT treatment Accordingly, we proposed that we the proposed rule, this would indicate begins. We proposed this because the would pay for complete episodes in two within the claims systems that an treatment planning service and the installments: One tied to when the episode has started. Upon submission of actual RT treatment do not always occur episode begins, and another tied to a claim with an RO Model-specific on the same day. when the episode ends. Under this HCPCS code and an SOE modifier, we We proposed that RO participants proposed policy, a Professional would pay the first half of the payment would be required to submit encounter participant would receive two for the PC of the episode to the data (no-pay) claims that would include installment payments for furnishing the Professional participant or Dual all RT services identified on the RO PC of an episode, a Technical participant. A Professional participant Model Bundled HCPCS list (See Table participant would receive two or Dual participant would be required to 2) as those services are furnished and installment payments for furnishing the bill the same RO Model-specific HCPCS that would otherwise be billed under TC of an episode, and a Dual participant code that initiated the episode with a the Medicare FFS systems. We proposed would receive two installment modifier indicating the EOE after the that we would monitor trends in payments for furnishing the PC and TC end of the 90-day episode. This would utilization of RT services during the RO of an episode. indicate that the episode has ended. Model. We proposed that these claims To reduce burden on RO participants, Upon submission of a claim with an RO would not be paid because the bundled we proposed that we would make the Model-specific HCPCS codes and EOE payments cover RT services provided prospective episode payments for RT modifier, we proposed that we would during the episode. We proposed that services covered under the RO Model pay the second half of the payment for the encounter data would be used for using the existing Medicare payment the PC of the episode to the Professional evaluation and model monitoring, systems by making RO Model-specific participant or Dual participant. specifically trending utilization of RT revisions to the current Medicare FFS Under our proposed billing policy, a services, and other CMS research. claims processing systems. We proposed Technical participant or a Dual We proposed that if an RO participant that we would make changes to the participant that furnishes the TC of an provides clinically appropriate RT current Medicare payment systems episode would be required to bill a new services during the 28 days after an using the standard Medicare Fee for RO Model-specific HCPCS code with a episode ends, then that RO participant Service operations policy related SOE modifier. We proposed that we would be required to bill Medicare FFS Change Requests (CRs). would pay the first half of the payment for those RT services. We proposed that As proposed, our design for testing a for the TC of the episode when a a new episode would not be initiated prospective episode payment model Technical participant or Dual during the 28 days after an episode (that is, the RO Model) for RT services participant furnishes the TC of the ends. As we explain in section would require making prospective episode and bills for it using an RO III.C.5.b(3) of this final rule, we refer to episode payments for all RT services Model-specific HCPCS code with a SOE this 28-day period as the ‘‘clean included in an episode, as discussed in modifier. We proposed that we would period.’’ section III.C.5 of this final rule, instead pay the second half of the payment for In the event that an RO beneficiary of using Medicare FFS payments for the TC of the episode after the end of changes RT provider or RT supplier services provided during an episode. the episode. We proposed that the after the SOE claim has been paid, we We proposed that local coverage Technical participant or Dual proposed that CMS would subtract the determinations (LCDs), which provide participant would be required to bill the first episode payment paid to the RO information about the conditions under same RO Model-specific HCPCS code participant from the FFS payments which a service is reasonable and with an EOE modifier that initiated the owed to the RO participant for services necessary, would still apply to all RT episode. As stated in the proposed rule, furnished to the beneficiary before the services provided in an episode. this would indicate that the episode has transition occurred and listed on the no- In the proposed rule, we stated that ended. pay claims. We proposed that this Professional participants and Dual Similar to the way PCs are billed, we adjustment would occur during the participants would be required to bill a proposed that we would develop new annual reconciliation process described new model-specific HCPCS code and a HCPCS codes (and any modifiers) for in section III.C.11 of this final rule. We modifier indicating the start of an the TC of each of the included cancer proposed that the subsequent provider episode (SOE modifier) for the PC once types. We proposed that payment for the or supplier (whether or not they are an the treatment planning service is TC would be made through either the RO participant) would bill FFS for furnished. We proposed that we would OPPS or PFS to the Technical furnished RT services. develop a new HCPCS code (and participant or Dual participant that Similarly, in the event that a modifiers, as appropriate) for the PC of furnished TC of the episode. We beneficiary dies, or chooses to defer each of the included cancer types under proposed that the two payments for the treatment after the PC has been initiated the Model. The two payments for the PC TC of the episode would cover the and the SOE claim paid but before the of the episode would cover all RT provision of equipment, supplies, TC of the episode has been initiated

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(also referred to as an incomplete for billing the RO Model-specific submission under the Model. A episode), during the annual HCPCS codes through the Medicare commenter noted operational concerns reconciliation process we proposed that Learning Network (MLN Matters) with the zero charge encounter bills the CMS would subtract the first episode publications, model-specific webinars, RO Model requires participants to payment paid to the Professional and the RO Model website. submit. The commenter stated that participant or Dual participant from the The following is a summary of the automated internal accounting software FFS payments owed to that RO public comments received on these generates both claims and internal cost participant for services furnished to the proposals and our response: accounting reports and that setting beneficiary and listed on the no-pay Comment: Several commenters charges to zero dollars would wreak claims before the transition occurred. expressed concern that billing systems havoc on internal cost tracking and In the event that traditional Medicare are not ready for a prospective payment would create significant administrative stops being the primary payer after the model as they are designed to bill after burden. The commenter requested that SOE claims for the PC and TC were the services are furnished and not CMS permit the original HCPCS charges paid, we proposed that any submitted before, and that this could pose to be listed in the non-covered charges’ EOE claims would be returned and the significant financial risk. Commenters claim column while zero dollars would RO participant(s) would only receive stated that the RO Model as proposed be submitted in the covered charges the first episode payment, regardless of introduces new billing and collection field. whether treatment was completed. If a processes to include new HCPCS and Response: We appreciate the beneficiary dies or selects the Medicare modifiers, billing at the start of and at commenters concern. We believe that hospice benefit (MHB) after both the PC the end of services, and the submission we have created a billing process that and the TC of the episode have been of no-pay claims detailing the actual will be easily implemented within initiated, we proposed that the RO services provided. Commenters further current systems because it is based on participant(s) would be instructed to bill stated that the complexity of learning how FFS claims are submitted today. To EOE claims and would be paid the new codes and tracking episode dates facilitate understanding and second half of the episode payment creates administrative burden for RO implementation, we encourage RO amounts regardless of whether participants. Commenters noted that participants to access forthcoming treatment was completed. many health care providers and health instructions for billing the RO Model- In the proposed rule we systems do not complete their billing specific HCPCS codes and related acknowledged that there may be internally, and instead rely on external modifiers and condition code provided instances where new providers and third party vendors so RO participants by CMS through the Medicare Learning suppliers begin furnishing RT services will require time to determine how to Network (MLN Matters) publications, in a CBSA selected for participation in best partner with these vendors to model-specific webinars, and the RO the RO Model. We proposed that these ensure appropriate billing. Model website. new providers and suppliers would be Many commenters expressed concern Comment: A commenter requested RO participants and noted that they around the lack of details regarding that CMS not withhold payments due to would have to be identified as such in billing requirements for the proposed incomplete episodes during the test the claims systems. When a claim is RO Model. Multiple commenters period, as this could ultimately create submitted with an RO Model-specific requested that we clarify in our billing significant cash flow issues. Instead, the HCPCS code for a site of service that is instructions that we will require commenter suggested that CMS could located within one of the CBSAs providers and suppliers billing utilize the new HCPCS codes and randomly selected for participation, as individual patient encounters to use modifiers intended as no-pay, initial identified by the service location’s ZIP HIPAA-mandated transaction code sets and ending payments as place holders Code, but the CCN or TIN is not yet (that is, CPT® and HCPCS Level II to assess the various scenarios for at identified as an RO participant in the codes) for Professional/Dual participant least 3 years. This 3-year testing period claims systems, we proposed that the services on 1500/837P claims and would at a minimum identify the claim would be paid using the rate hospital outpatient participant services scenarios and allow time for CMS to assigned to that RO Model-specific on UB04/837I. Commenters stated that assess, realize impact, and provide data HCPCS code without the adjustments. it was particularly important that to the public for public comment. Once we are aware of these new charges meet the requirements of the Response: We thank the commenter providers and suppliers, we proposed Provider Reimbursement Manual Part 1 for the suggestion. In the final rule at that they would be identified in the section 2202.4, which mandate that § 512.255(h), we have reduced the claims system and would be paid using charges be related consistently to the incorrect payment withhold from the Model-specific HCPCS code with or cost of the services and uniformly proposed 2 percent to 1 percent, which without the adjustments, depending on applied to all patients, whether is proportional to the occurrence of whether the TIN or CCN new to the Medicare, Medicaid, or commercial incomplete episodes per our claims Model is a result of a merger, patients. Commenters stated that the RO data. The amount of the incorrect acquisition, or other new clinical or Model cannot alter these requirements withhold that the RO participant earns business relationship and whether there because doing so could undermine the back is determined during the annual is sufficient data to calculate those validity of the hospital cost reporting reconciliation process described in adjustments as described in the pricing process. Commenters requested that we section III.C.11. methodology section III.C.6 of this final address the following items for the new Comment: Many commenters rule. prospective HCPCS codes and the no- expressed concern around the proposed We proposed that lists of RO Model- pay claims: (1) The type of claim form; billing timing requirements, stating that specific HCPCS codes would be made (2) necessary claim lines; (3) items that it was not clear from the proposed rule available on the RO Model website prior should be excluded from the claim; and how Technical participants would know to the Model performance period. In (4) ability to move the zero-pay HCPCS when a Professional participant started addition, we noted in the proposed rule codes to the non-billable column on the an episode for one of their patients at that we expect to provide RO claim. Commenters asked for the time that patient presented for participants with additional instructions clarification on encounter claim data radiation therapy treatment.

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Commenters were concerned that circumstances, the component that is full payment at the beginning of the without this knowledge, unnecessary submitted will be addressed during the episode, rather than payment in two incomplete episodes might result. reconciliation process finalized in installments, would improve cash flow However, these commenters were also section III.C.11, and the payments will and reduce administrative burden by concerned that the burden of be reconciled so that the RO participant not requiring an EOE claim. Other coordination of episode start dates receives the FFS amount based on the commenters requested that providers between professional and Technical no-pay claims instead of the participant- and suppliers be able to receive the 2nd participants could greatly increase the specific episode payment. We encourage payment sooner than 90 days, ideally administrative burden of the Model. RO participants to access forthcoming when the services complete. A One commenter stated that unique instructions provided by CMS for billing commenter requested that CMS consider logic would have to be established for the RO Model-specific HCPCS codes adding a modifier to signal a course of each patient to track how many days the and related modifiers and condition radiation is completed and that CMS Technical participant’s billing team code provided by CMS through the should make the 2nd half of the would need to zero out claims since RT Medicare Learning Network (MLN payment at the time that completion start dates within the 90-day period will Matters) publications, model-specific claim is submitted rather than waiting vary. Other commenters noted that webinars, and the RO Model website. for the end of the 90-day period. In when entities billing TC and PC services Comment: Commenters requested addition, that commenter also stated are clinically, financially, and legally clarification on how billing was to be that adding a modifier to the start and separate, the likelihood of their ability done when either the technical end of a course of treatment would to coordinate care declines. Noting that component of the services and/or the signal if a new course, not related to Health Information Exchanges are not professional component of the services previous course, started during the 90- yet broadly available and that sharing of extends beyond the 90-day episode day time frame. information is not the same as triggered by the planning services. Response: We thank the commenters coordinating care, a commenter Response: To clarify, as stated in the for expressing their concerns and for requested a delay in implementation to proposed rule, all RT services provided their suggestions. Based on these allow participants to establish the within the 28-day clean period (that is, comments, we are modifying our policy formal or informal relationships likely days 91–118) following a 90-day RO to permit an RO participant to submit necessary to succeed in the proposed episode will be billed FFS. In these the EOE claim after the RT course of Model. Another commenter situations, the RT provider or RT treatment has ended, but no earlier than recommended that CMS include in the supplier will bill individual HCPCS or 28 days after the initial treatment Model a methodology by which it CPT® codes for each RT service planning service was furnished. We would notify Technical participants of furnished as they would outside of the believe that 28 days after the initial the start of an episode. A commenter RO Model. If RT services are still being treatment planning service was noted that CMS stated that the technical provided after 118 days, the RO furnished is the earliest that EOE claims billing component will be driven off a participant will submit a SOE claim for should be submitted, because if the TC signed radiation prescription. As there a new RO episode. We encourage RO has not been furnished to an RO is a professional as well as technical participants to access forthcoming beneficiary after 28 days, this would be component of the simulation session, instructions for billing RT services an incomplete episode, as defined at the commenter stated that CMS should during the Model performance period § 512.205. To ensure that a Professional use the professional simulation session provided by CMS through the Medicare participant or a Dual participant does claim to trigger for the technical SOE. Learning Network (MLN Matters) not bill an EOE claim for an incomplete Response: We appreciate the publications, model-specific webinars, episode, they should not submit an EOE commenters’ concerns. We believe it to and the RO Model website. claim before 28 days after the initial be an established standard of care that Comment: Multiple commenters treatment planning service has been RT delivery services cannot be expressed concerns about the timing of furnished to minimize the need to administered to a patient without a our proposed payments. A commenter reconcile the EOE payments against the signed radiation prescription and the stated that the time estimates CMS has incorrect payment withhold. Regardless final treatment plan. Thus, we proposed made available show that almost two of when the EOE claim is submitted, the that the Professional participant will thirds of all episodes are completed episode duration remains 90 days. Any provide the Technical participant with within 50 days while other commenters RT services furnished after the EOE a signed and dated radiation noted most services are completed claim is submitted will not be paid prescription and treatment plan, all of within a month of initiating treatment. separately during the remainder of the which is usually done electronically. Commenters noted that under our RO episode. We will monitor the This will inform the Technical proposal, most providers and suppliers Medicare claims system to identify participant of when the RO episode would have to wait more than a month potentially adverse changes in referral, began, allowing them to determine the to be able to bill for care that has already practice, or treatment delivery patterns date of the end of the RO episode. The been provided. Commenters expressed and subsequent billing patterns. This submission and payment of TC claims is concerns that delayed payments will modification does not require a change not dependent on the submission of PC impact their cash flows, creating to the regulatory text at § 512.260. claims. If the TC claim with the SOE hardships in their ability to pay bills, to Comment: Some commenters stated modifier is received first, the claims order medical supplies and to provide that CMS does not describe how a system will estimate the first day of the the necessary staffing coverage. Professional participant (that is, the episode. A similar process will occur for Commenters also expressed concern individual radiation oncologist or the EOE claims. When claims for only one that patient access might become an radiation oncology physician group/ component are submitted (either PC or issue due to these cash flow delays and practice TIN) who is selected to be in TC), an RO episode would not have that beneficiaries might have to drive the Model via an included ZIP Code, but occurred because an RO episode begins further to get care when staffing is who furnishes their RT services at an when both the PC is initiated and the compromised because of delayed exempt facility (ASC, PCH, CAH), is to TC is initiated within 28 days. In these payments. A commenter suggested that bill for those encounters. The

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commenters questioned how a non- provides brachytherapy services. The within the 28-day period, but the participant RT provider or RT supplier commenter wanted clarification on physician plans to treat the patient with would be protected from having a large when the brachytherapy physician RT services, that there may be no volume of incomplete episodes. A would be considered part of the RO ‘‘trigger’’ to begin an episode of care. commenter noted that during the Model and when the brachytherapy Commenters requested that we clarify August 22, 2019 Open Door Forum physician would be paid FFS. A how Medicare Administrative Listening Session on the Radiation commenter requested that CMS provide Contractors will manage PC and TC Oncology Model, CMS staff stated they clarification regarding how the agency claims after the 28-day window between would create a modifier for Professional will handle a second claim for a case the treatment planning code and the participants to use to indicate that RT that has already received an episodic treatment delivery code has passed services were furnished by a non- payment associated with a second without triggering an episode. participant. Commenters requested that physician who bills the brachytherapy Commenters also requested that we CMS consider an alternative to a new insertion codes. The commenter stated provide answers to the following modifier that does not require any that accommodations should be made to questions: Would all subsequent PC and changes in how professionals bill their pay the insertion codes at the FFS rate TC claims be paid as FFS? Would the radiation oncologist services. A when a second physician is involved to TC claims (either with the RO Model- commenter suggested that CMS use the prevent cash flow issues that could specific HCPCS code or FFS HCPCS location of services in item number 32 result if the second claim were held up code) and the second PC episode and the NPI in item 32a on the 837P/ as part of the RO Model reconciliation payment claims be denied and then 1500 claim form, which is mandated on process. reconciled as per the incomplete the 837P/1500 claim form, to exclude Response: When RT services are episode policy in the proposal? Would the services from the RO Model. furnished by an RO participant and a all TC claims after the 28-day window Commenters also suggested that instead non-participant or when the PC is be paid under FFS and the initial of creating another modifier, CMS could furnished by more than one Professional episode PC payment be the only amount direct Professional participants who participant or Dual participant, or when reconciled? The commenter urged CMS deliver services at exempt facilities to the TC is provided by more than one to pay all CPT®/HCPCS codes that are bill the usual radiation oncology HCPCS Technical participant or Dual billed outside of the 28-day window codes, and to not initiate an episode by participant, these scenarios would be (that is an incomplete episode) as FFS. excluding the RO Model-specific considered duplicate services. The RO Response: We appreciate the HCPCS code. Commenters further beneficiary would remain under the commenters’ concerns. Medicare claims requested that if CMS believes it must care of the RO participant that initiated data analyzed during the design of the require the use of a new modifier to the PC and/or TC, and in many RO Model, show that in 84 percent of signify services in an exempt facility, circumstances, the duplicate RT service episodes RT is delivered within 14 days we should allow the modifier to be would be a different modality than what of the planning service and within 28 reported with the usual RT planning, is furnished by the RO participant. The days for the remaining 16 percent. There simulation, and management CPT® and RO participant(s) that bills the SOE and will be billing instructions that address HCPCS codes rather than asking for the EOE claims would receive the bundled how to submit claims for those RO Model-specific HCPCS code to be payment and the RT provider and/or RT instances that do not follow the reported. supplier furnishing one or more standard course of an episode. In these Response: CMS worked closely with duplicate RT services would bill claims situations, the RT provider or RT the Provider Billing Group in the Center using the designated modifier or supplier will bill individual HCPCS or for Medicare, the Medicare condition code to indicate that they CPT® codes for each RT service Administrative Contractors, and the should be paid FFS. Thus, cash flow furnished as they would outside of the Shared System Maintainers to establish would not be affected by this. We RO Model. These scenarios would be the least burdensome way to submit encourage RO participants to access considered incomplete episodes. We claims for instances that do not follow forthcoming instructions for billing RT encourage RO participants to access the standard course of an episode. We services during the Model performance forthcoming instructions for billing RT determined that the use of an period provided by CMS through the services during the Model performance established modifier for professional Medicare Learning Network (MLN period provided by CMS through the claims and a condition code for HOPD Matters) publications, model-specific Medicare Learning Network (MLN claims would be the best way to webinars, and the RO Model website. Matters) publications, model-specific indicate that certain services fall outside Comment: Some commenters webinars, and the RO Model website. of an RO episode and should be paid expressed concerned about specific Comment: A commenter expressed FFS. When services are furnished by a considerations related to the proposed appreciation that CMS has taken into participant and a non-participant, these 90-day episodic billing time frame. consideration situations in which a scenarios would be considered Commenters agreed with our patient passes or is transferred to incomplete episodes. We encourage RO assumption that RT services would hospice care during an RO episode, participants to access forthcoming generally be completed within the 90- noting that in these situations, CMS instructions for billing RT services day episodic period and a new RO proposed to provide full payment and during the Model performance period episode would not begin until at least not to consider these two scenarios as provided by CMS through the Medicare 28 days have elapsed, but commenters incomplete episodes. Learning Network (MLN Matters) noted that there are times when Response: We thank the commenter publications, model-specific webinars, extenuating circumstances like an for the support and note that we are and the RO Model website. inpatient admission or preplanned finalizing the policy to provide full Comment: A commenter requested patient travel that can cause the payment for RO episodes in which a clarification on billing when one outpatient RT services to begin after the patient passes or is transferred to physician provides EBRT and a different 28-day window. From an operational hospice care during an RO episode. physician, either co-located in the same standpoint, commenters were concerned Comment: A commenter requested facility or in a different facility, that if the treatment does not begin that we change the proposed policy in

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cases where the patient moves from IOM publications by CMS provide few Response: The RO Model-specific traditional Medicare FFS as their instructions specific to radiation HCPCS codes will be posted on the RO primary payer to a Medicare Advantage oncology techniques, required Model website at least 30 days prior to plan during an episode. As proposed, documentation, and coverage the start of the Model. As described in the commenter noted that CMS would requirements, which leads to section III.C.6.h, there are RVUs pay 50 percent of both the PC and TC inconsistency across the specialty. The associated with the RO Model-specific to participants, regardless of whether commenter asked if there is a reason HCPCS codes, but the SOE and which the RT was complete. The commenter there are not more LCDs or possible are modifiers, not codes do not have stated that they believe this payment National Coverage Determinations RVUs associated with them. policy would not fairly reimburse RO (NCDs) if there is an expectation that Comment: A commenter stated that participants for services rendered, and radiation oncology facilities are to the RO Model will require staff to recommended that we drop these follow a common set of guidelines and determine which patients are primary episodes and revert retrospectively to expectations for coverage. Another Medicare from all other payers and FFS payments for the services that were commenter stated that LCDs are a form establish separate processes between billed to Medicare Part A and B, in the of prior authorization and requested that payers and between those who fall same manner that we proposed to do for CMS abandon the use of LCDs to under the RO Model parameters and other categories of incomplete episodes. determine coverage for those services those who do not. The commenter Response: We thank the commenter delivered to Medicare beneficiaries as stated this would include creating two for their concern and suggestion. Our part of the RO Model. The commenter sets of coding and billing processes just analysis indicates that for episodes stated that the establishment of episode- for primary Medicare beneficiaries: One where a beneficiary moves from based payments effectively decouples to report services included in the RO traditional Medicare as their primary payment from modality of treatment and Model and one to report services not payer to a Medicare Advantage plan that LCDs or other methods of prior included and billed as fee-for-service for during the RO episode, the average cost authorization should not apply for the those services provided to a beneficiary is less than 50 percent of those episodes RO Model. who must participate in the Model but when compared to episodes where a Response: LCDs are decisions made for whom some services provided are beneficiary had Medicare as their by a Medicare Administrative not included and billed differently. primary payer for the full 90-day Contractor (MAC) whether to cover a Response: It is our understanding that episode. Thus, we believe that paying particular item or service in a MAC’s RT providers and RT suppliers furnish the SOE PC and TC only in these cases jurisdiction (region) in accordance with and bill for RT services for patients with is appropriate. Our data also shows that section 1862(a)(1)(A) of the Social a variety of insurers and thus already switching payers during an episode Security Act. The MAC’s decision is have processes in place to accommodate rarely occurs. When an RO beneficiary based on whether the service or item is multiple payer requirements. To clarify, ceases to have traditional Medicare as considered reasonable and necessary. non-included services will be billed his or her primary payer during an RO The MACs will not have the ability to separately and in the same manner as episode, the RO participant will not be apply LCDs to RO Model claims because they would in the absence of the RO paid the EOE PC or TC because CMS only the RO Model-specific HCPCS Model. cannot process claims for a beneficiary codes appear on the claim and these Comment: A commenter asked us to with dates of service on or after the date codes are not included in any current clarify if the 8 percent non-sequestration that traditional Medicare is no longer LCDs. When we monitor utilization of reconciliation withhold will be the primary payer. We believe that RT services during the Model, as processed at the claim level so that finalizing our proposal with the described in section III.C.14.a, we will adjustments can be applied to the modification allowing the EOE claim to use the reasonable and necessary original claims via remits. be submitted and paid at the completion provisions as stated in applicable LCDs Response: We believe the ‘‘8 percent’’ of the planned course of treatment, as one of our monitoring tools. used by the commenter refers to the instead of waiting for 90 days, will Comment: A commenter requested total of the discounts and withholds. mitigate this concern. If the RO that we address prior authorization, The discounts and withholds are not beneficiary has traditional Medicare as which the commenter asserted could subject to sequestration upon of the date of service on the EOE claim, impact the outcomes and treatment submission of an RO Model claim. the RO participant will be paid both choices in this Model. The commenter Sequestration will be applied to installments of the episode payment. expressed concern that prior reconciliation payment calculation that Comment: Several commenters authorization requirements could are based on FFS payments. expressed concern about our proposed increase administrative burden on Comment: Commenters expressed policy that local coverage participating clinicians who seek to concern about specific billing situations determinations would still apply to all deliver the highest quality of care and and asked for clarification on several RT services provided in an episode. A delay timely payment for covered situations. A commenter asked for commenter noted that at this time, there services. clarification on how organizations are few LCDs in publication and that Response: We thank the commenter should handle or bill for treatment of most radiation oncology specific LCDs for voicing these concerns. RO Model new manifestations of same cancer have been retired, with the exception of services are not subject to prior diagnosis within the same 90-day those for proton therapy and a few other authorization. window (estimated 10–20 percent of LCDs for IMRT, SRS and SBRT. The Comment: Commenters asked if patients). Another commenter, citing an commenter further noted that currently allowable rates will be available for the example of a prostate cancer patient there are no active LCDs for standard new codes 30 days prior to program with bone metastasis or a lung cancer external beam, 3D conformal, start date. Commenters asked if there patient with brain metastasis, inquired brachytherapy or radiopharmaceutical will be an RVU associated with the new if a patient presents with two separate therapy, and that multiple MACs have start and end codes and if there be diagnoses that are included within the never published radiation oncology unique start and end codes per Model, would the HCPCS codes be LCDs. The commenter stated that the diagnosis. reported for both cancer type codes or

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would one take precedence over Typically, a secondary bill is sent the commenter stated that the playing another? Commenters asked if this directly from Medicare to the secondary field would not be level and would would this be considered a single payer. If a no-pay bill is sent to a favor HOPD over freestanding radiation episode or separate episodes? secondary payer, it would not be paid. therapy centers. The commenter also Commenters also sought clarification on Commenters noted that it was requested that we clarify if facility fees billing for non-RO Model codes. If a particularly important for all were included in our computation patient in an RO episode also is treated participants to follow usual coding and finding that freestanding centers billed for a non-model code (for example, billing pursuant to HIPAA transaction more than HOPPS facilities. If so, the metastasis to adrenal gland), would sets due to the impact on a beneficiary’s commenter requested that hospitals not those services be billed and paid for secondary and MediGap insurance. be allowed to charge facility fees under under FFS even though an RO episode Commenters noted that CMS did not the RO Model. is running concurrently? A commenter address this topic in the Proposed Rule Response: As proposed, only RO also asked for clarification on how RO and stated that they expect that the Model-specific HCPCS codes are participants should bill for non-model Innovation Center would define new allowed on the SOE and EOE claims. services which, if not for the Model, claim adjustment reason codes (CARC) Thus, this should not be a concern. would be bundled under the existing and remittance advice reason codes Comment: A commenter suggested OPPS RO Comprehensive ambulatory (RARC) so this insurance, when that CMS should publish online an payment classification (C–APC)? The secondary to Medicare, will not process explicit list of providers and suppliers commenter recommended that co-payments for individual services. excluded from the Model including providers and suppliers be permitted to Instead, they will process applicable co- their names, addresses, and NPIs to bill separately under the OPPS for these payments associated with each of the ensure there’s no confusion about which other non-Model HCPCS and CPT® professional, dual, and technical providers and suppliers are excluded codes. episode payments when made and from the Model. The commenter stated Response: Only one RO Model- explained on the remittance advice from that this information would also specific HCPCS code will apply to an Medicare. Commenters asked that CMS emphasize that, should any of the RO episode even if the RO beneficiary verify and explain this process in the professionals furnish services at a has more than one included cancer type Final Rule to enable RO participants to location included in the RO Model and for which they are receiving RT better understand these important their TIN/ZIP Code is not otherwise services. The RO participant can choose operational issues. excluded from the Model, the which RO Model-specific HCPCS to Commenters requested that CMS participant would be required to report include on both the SOE and EOE verify and explain the process for the HCPCS Level II code for the cancer claims. For example, the RO beneficiary communication to secondary and type and the appropriate modifier(s). is being treated with RT services for MediGap insurance (that is, CARC/ The commenter also suggested that, if breast cancer and brain metastasis, the RARC codes) to ensure all participants CMS believes it must require the use of RO participant would likely choose the have a clear understanding of the a new modifier to signify services in a RO Model-specific HCPCS for breast operational process for reimbursement. provider or supplier excluded from the cancer, which is appropriate. If an RO Commenters also noted that as other Model, the agency allow the modifier to beneficiary has more than one included payers would be following typical FFS be reported with the usual RT planning, cancer type, but is receiving RT services payment methodology, the ‘‘M’’ codes simulation, and management CPT® and for just one, the RO participant is would not be accepted either. HCPCS codes rather than ask for the expected to put the corresponding RO Commenters requested that we address cancer type HCPCS code to be reported. Model-specific HCPCS code on the SOE the following questions: Will the The PRT recommends that CMS utilize and EOE claims. For example, the RO Medicare beneficiary then be at risk for the information already required by beneficiary has breast cancer, but is the 20 percent liability if denied? How HIPAA transaction sets (NPI, names, being treated with RT services for just would secondary payers adjudicate and addresses) for professional claims their brain metastasis, the RO these claims? Many payers have 60-day in order to determine if a provider or participant must choose the RO Model- timely filing deadline. With the supplier is excluded from the Model, specific HCPCS for brain metastasis. If proposed billing model, commenters rather than creating a new modifier and an RO beneficiary also receives expressed concern that they would be at additional operational burden for RT included RT services for a non-included risk of timely filing for certain payers if professionals. cancer type, FFS claims would be those claims are not adjudicated. Response: Only RO participants can submitted with the corresponding ICD– Response: CMS liaisons to the use the RO Model-specific HCPCS 10 codes and HCPCS codes. As secondary payers will provide RO codes. The claims system will proposed, the SOE and EOE claims must Model-specific information to those determine inclusion in the Model by the include the same RO Model-specific payers including how the RO Model- site of service ZIP Code included on the HCPCS code. RT services not included specific HCPCS shall be processed. As claim. Non-participants would not be in Table 2 shall be billed FFS. To noted in the proposed rule, we expect required to use a modifier to indicate clarify, non-included services will be to provide RO participants with they are not subject to RO Model billing billed separately and in the same additional instructions for billing, requirements. To facilitate manner as they would in the absence of particularly as it pertains to secondary understanding and implementation of the RO Model. payers and collecting beneficiary the billing and payment requirements, Comment: Commenters sought coinsurance. Additional instructions we encourage RO participants to access clarification on secondary billing under will be made available through the additional instructions for billing during the Model, requesting that we provide Medicare Learning Network (MLN the RO Model and using the RO Model- clarification in the final rule regarding Matters) publications, model-specific specific HCPCS codes provided by CMS the role of secondary payers and how webinars, and the RO Model website. through the Medicare Learning Network they will be engaged as part of the Comment: A commenter asked if (MLN Matters) publications, model- claims processing and billing associated hospitals are still allowed to add facility specific webinars, and the RO Model with implementing the Model. fees to their fees under the Model. If so, website.

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Comment: A commenter stated that would like our policy not to delay section III.C.11 of the proposed rule (84 freestanding centers are not authorized hospice referrals. FR 34527) and this final rule. to bill directly to Medicare due to the We proposed that the AQS would be consolidated billing requirements for 8. Quality based on each Professional participant’s SNF and hospital inpatient stays. In this We proposed to implement and score and Dual participant’s: (1) Performance scenario, the commenter believed the a set of quality measures, along with the on the set of evidenced-based quality treatment delivery code would not be clinical data elements (proposed in measures in section III.C.8.b of the received for beneficiaries during a SNF section III.C.8.e of the proposed rule (84 proposed rule (84 FR 34515 through or hospital inpatient stay who are also FR 34514) and discussed in section 34517) and this final rule compared to treated with RT services in a III.C.8.e of this final rule) according to those measures’ quality performance freestanding radiation therapy center. the Aggregate Quality Score (AQS) benchmarks; (2) reporting of data for the Response: We have programmed the methodology (described in section pay-for-reporting measures (those claims system to bypass all professional III.C.8.f of the proposed rule (84 FR without established performance and institutional SNF consolidated 34519)). We proposed that beginning in benchmarks) in section III.C.8.b(4) of the billing edits/IURs for RO Model claims PY1, the AQS would be applied to the proposed rule (84 FR 34515 through for any RO beneficiary that is currently quality withhold (described in section 34517) and this final rule; and (3) reporting of clinical data elements on in a Skilled Nursing Facility (SNF) stay. III.C.6.g(2) of proposed rule (84 FR applicable RO beneficiaries in section Based on these public comments we 34509) and discussed in this final rule) III.C.8.e of the proposed rule (84 FR are finalizing our proposals related to to calculate the quality reconciliation 34518) and this final rule. As stated in billing and payment at § 512.260 and payment amount due to a Professional the section III.C.8.f.(1) of the proposed § 512.265, with modification. participant or Dual participant as rule (84 FR 34519), in the absence of a Specifically, we are adding a new specified in section III.C.11 of the MIPS performance benchmark, national paragraph (d) to § 512.260 to codify the proposed rule (84 FR 34527) and this benchmark, or historical performance requirement that an RO participant final rule. As proposed, results from from which to calculate a Model- submit no-pay claims for any medically selected patient experience measures specific benchmark from previous years’ necessary RT services furnished to an based on the CAHPS® Cancer Care RO beneficiary during an RO episode historical performance, a quality survey would be incorporated into the measure will be included in the pursuant to existing FFS billing AQS for Professional participants and processes in the OPPS and PFS, as was calculation of the AQS as pay-for- Dual participants starting in PY3. For reporting until a benchmark is described in this section of the final Technical participants, results from rule. Additionally, as noted earlier in established that will enable it to be pay- these patient experience measures for-performance. Based on the this section of the final rule, we are would be incorporated into the AQS permitting an RO participant to submit considerations set forth in the proposed starting in PY3 and applied to the the EOE claim after the RT course of rule, we proposed the following patient experience withhold described treatment has ended, but no earlier than measures for the RO Model beginning in in section III.C.6.g(3) of the proposed 28 days after the initial treatment PY1 and continuing thereafter: rule (84 FR 34509 through 34510) and planning service was furnished. • Oncology: Medical and Radiation— this final rule. Regardless of when the EOE claim is Plan of Care for Pain—NQF 45 #0383; submitted, the episode duration remains a. Measure Selection CMS Quality ID #144 90 days. Any RT services furnished after • Preventive Care and Screening: the EOE claim is submitted will not be We proposed that the following set of Screening for Depression and Follow- paid separately during the remainder of quality measures would be included in Up Plan—NQF #0418; CMS Quality ID the RO episode. the RO Model in order to assess the #134 Further, we would like to clarify that quality of care provided during episodes • Advance Care Plan—NQF #0326; CMS we are finalizing at § 512.245(b) that if (84 FR 34514). We proposed that we Quality ID #047 an RO beneficiary dies after both the PC would begin requiring annual quality • Treatment Summary and the TC of the RO episode have been measure data submission by Communication—Radiation Oncology initiated, we proposed that the RO Professional participants and Dual We proposed adopting this set of 44 participant(s) would be instructed to bill participants in March of 2021 for quality measures for the RO Model for EOE claims and would be paid the episodes starting and ending in PY1. two reasons. First, the RO Model is second half of the episode payment Participants would continue to be designed to preserve or enhance quality amounts regardless of whether required to submit quality measure data of care, and these quality measures treatment was completed. And, if an RO annually every March through the would allow us to quantify the impact beneficiary elects the MHB not only remainder of the Model performance of the RO Model on quality of care, RT after the PC and TC of an RO episode period as described in section III.C.8.c services and processes, outcomes, has been initiated but also before the TC of the proposed rule (84 FR 34517 patient satisfaction, and organizational is initiated as long as the TC is initiated through 34518) and this final rule. structures and systems. Second, we within 28 days following the initial These quality measures would be used believe the RO Model measure set treatment planning service (PC), the RO to determine a participant’s AQS, as would satisfy the quality measure- participant(s) will receive both described in section III.C.8.f of the related requirements for the RO Model installments of the episode payment proposed rule (84 FR 34519) and this to qualify as an Advanced APM, and a amount (upon billing the RO Model- final rule, and subsequent quality MIPS APM, which we discuss in greater specific HCPCS codes and the SOE and reconciliation amount, as described in detail in section III.C.9 of this final rule. EOE modifiers) regardless of whether Because they have already been adopted the RO episode has been completed. We 44 We are finalizing the inclusion of quality in MIPS, we believe that the following measures in the RO Model in section III.C.8.b, and recognize that the TC may not always be finalizing that the first annual quality measure data measures meet the requirements of 42 furnished on the same day, as the PC, submission will occur in March 2022 as finalized or within a few weeks of the PC, and we in section III.C.8.c. 45 National Quality Forum.

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CFR 414.1415(b)(2): (1) Oncology: in the radiation oncology sector, and to participants the opportunity to select a Medical and Radiation—Plan of Care for calculate overall performance using the subset of measures from the larger set to Pain; (2) Preventive Care and Screening: AQS methodology; however, CMS may report. Screening for Depression and Follow- adjust the measure set in future PYs by Response: In selecting measures for Up Plan; and (3) Advance Care Plan. We adding or removing measures as needed. the RO Model, we sought to include a further believe that the Treatment If changes to the measure set are set of meaningful, parsimonious Summary Communication—Radiation necessary, we will propose those measures, reflective of the CMS Oncology measure is evidence-based, changes in future rulemaking.46 Meaningful Measures framework 47 that reliable, and valid because it has been We solicited comment on this balances the need for data about developed by stakeholders to ensure proposal. The following is a summary of participant performance without timely handoff communication and care the public comments received on this creating undue burden on participants. coordination to referring health care proposal and our response: One set of measures used by all RO providers and patients receiving Comment: Several commenters participants will provide insight for radiation therapy treatment. We supported CMS’ proposal to include CMS and the field as a whole into how acknowledge that we did not propose an quality measures and believed that care quality compares across multiple outcome measure for the RO Model as quality measures will ensure that markets. Selective reporting of measures required under 42 CFR 414.1415; quality care is delivered under the RO would hinder the ability of CMS to however, as we explained in the Model. measure or analyze the impact of the proposed rule (84 FR 34515), this is Response: We thank the commenters Model on quality. because there are no available or and appreciate their support. Comment: A few commenters applicable outcome measures included Comment: A few commenters expressed their belief that the Model in the MIPS final quality measures list expressed support for use of NQF- should only include measures related to for the Advanced APM’s first Qualifying endorsed measures generally. Other patient safety and health care provider APM Participants (QP) Performance commenters specifically opposed the engagement to ensure the delivery of Period. We have determined there are inclusion of any measure that is not high-quality care within the Model. currently no outcome measures NQF-endorsed in the RO Model. Response: We agree that patient safety available or applicable for the RO Model Response: While NQF endorsement is is of paramount importance; we will so this requirement does not apply to not required when selecting measures assess patient safety via claims, site the RO Model. However, if a potentially for the RO Model, we agree with the visits, and data that RO participants are relevant outcome measure becomes commenters that NQF endorsement is required to submit for monitoring and available, we would consider whether it one of several important criteria to evaluation. However, we believe it is is applicable and should be proposed to consider. Three of the quality measures important to capture elements of quality be included in the RO Model’s measure that we proposed for the Model are care that go beyond patient safety and set. currently NQF-endorsed. A fourth, the health care provider engagement. The As stated in the proposed rule, we measure ‘‘Treatment Summary selected measures will encourage believe our proposed use of quality Communication,’’ was initially providers and suppliers to engage with measures as described in our AQS endorsed by NQF in 2008, but was not CMS and their patients to ensure that scoring methodology in section III.C.8.f subsequently brought by the measure patients are receiving high-quality care. of the proposed rule (84 FR 34519) and steward for maintenance/re- All measures were selected based on this final rule would meet the current endorsement. However, we believe the clinical appropriateness for RT services quality measure and cost/utilization information captured by this measure is spanning a 90-day episode period. MIPS APM criterion under 42 CFR relevant to the RO Model and critical to Additionally the Model must include a 414.1370(b)(3). In selecting the patients’ care continuity and sufficient set of quality measures to proposed measure set for the RO Model, coordination. We believe that any qualify as a MIPS APM and an we sought to prioritize quality measures measure that is evidence based and Advanced APM. that have been endorsed by a consensus- would support the goals of the Model, Comment: A couple of commenters based entity or have a strong evidence- that has been tested to produce valid recommended that national based focus and have been tested for and reliable results, and that is effective accreditation through the American reliability and validity. We focused on without being overly burdensome, may College of Radiology (ACRO) or measures that would provide insight be appropriate for inclusion in the American Society for Radiation and understanding into the Model’s Model. Therefore, we do not believe that Oncology (ASTRO) should be sufficient effectiveness and that would facilitate the lack of current NQF endorsement to meet quality standards for the Model achievement of the Model’s care quality alone should preclude a measure’s and that accredited PGPs in the Model goals. We also sought to include quality adoption since endorsement, as it is should not need to report additional measures that align with existing quality only one of several considerations. quality data to CMS. The commenters measures already in use in other CMS Comment: A commenter believed that the collection and quality reporting programs, such as recommended that CMS add additional submission of additional quality data to MIPS, so that Professional and Dual measures to the RO Model and allow CMS is unlikely to add value to the participants would be familiar with the effort to improving radiation oncology measures used in the Model. Finally, we 46 When there is reason to believe that the care. A commenter supported considered cross-cutting measures that continued collection of a measure as it is currently accreditation and believed it enhances would allow comparisons of quality specified raises potential patient safety concerns, CMS will take immediate action to remove a quality of care. Another commenter across episode payment models and measure from the program and not wait for the supported American College of other CMS model tests. annual rulemaking cycle. In such situations, we As we stated in the proposed rule, we would promptly retire such measures followed by Radiology (ACR) accreditation for larger believe the proposed measure set would subsequent confirmation of the retirement in the next rulemaking. When we do so, we will notify 47 https://www.cms.gov/Medicare/Quality- provide the Model with sufficient participants and the public through the usual Initiatives-Patient-Assessment-Instruments/ measures for the Model performance communication channels, which include RO Model QualityInitiativesGenInfo/MMF/General-info-Sub- period to monitor quality improvement website and emails to participants. Page.html.

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centers with a full-time radiologist on radiation oncology sector; they align healthy tissue to radiation) and the site. with existing measures being used in efficacy of treatment. Response: We agree with the quality programs; and they will allow MedPAC specifically recommended commenters that accreditation by the Model to qualify as an Advanced using three claims-based measures, the nationally recognized organizations, APM and a MIPS APM. However, we second and third of which are currently such as the ACR, ACRO, and ASTRO, will consider revisions to this measure used in the OCM: (1) The risk-adjusted may be an indicator of the overall set for future model years. We will proportion of patients with all-cause quality of care provided by a RT continue to monitor other measures that hospital admissions within the six- provider or RT supplier. However, we become available and meet the criteria month episode, (2) risk-adjusted do not believe that accreditation for the Model, including seeking proportion of patients with all-cause provides a full picture of quality care opportunities to align with quality emergency department (ED) visits or delivery in radiation oncology. As noted measure efforts conducted by observation stays that did not result in earlier in this final rule, the Model must professional societies. As we consider a hospital admission within the six- include a set of quality measures to additional measures for inclusion in the month episode, and (3) proportion of qualify as a MIPS APM and an Model, we will consider which patients that died who were admitted to Advanced APM, and as such, measures will allow the most hospice for three days or more. accreditation is not able to replace the meaningful and parsimonious measure Response: For PY1, we proposed four RO quality measures without set to ensure continued RT quality, measures. Several outcome measures compromising the Model’s qualification while requiring the least amount of (some of which are registry-based as a MIPS APM and Advanced APM. In burden on providers and suppliers. measures), including those suggested by addition, while we are not using Throughout the Model performance commenters, were considered prior to accreditation status as a proxy for period, we will be seeking input from the publication of the proposed rule. In quality, as stated in section III.C.13.c we stakeholders on potential quality the end, we did not include these may at some point use an optional web- measure while continuing to monitor outcome measures in the proposed based survey to gather data from the RT field for new and promising measure set due to concerns over the participants on administrative data measures. significant challenge of attributing points, including their accreditation Comment: We received many outcomes—such as those suggested by status, indicating the importance of this comments related to measuring RO MedPAC including hospital admissions, information to understanding Model outcomes addressing multiple ED visits, or proportion of patients that participants’ activities. topics including: (1) The importance of died who were admitted to hospice— Comment: We received numerous including an outcome measure in directly to RT services. comments requesting the addition or APMs; (2) suggestions for making We would have liked to use the same development of additional RT measures progress on creating a radiation therapy- OCM outcome measures for the RO to ensure the provision of high-quality specific outcome measure for future Model, but ultimately decided that it care. Commenters specifically implementation; and (3) alternatives to would be difficult to discern whether recommended the following topics for a clinical outcomes measure that CMS these outcomes occurred due to measures: Tracking the toxicity of can use to track outcomes for RO complications from RT service, treatment; the utilization of surface beneficiaries. Many commenters chemotherapy by medical oncologists, guided radiation therapy (SGRT); expressed support for inclusion of an or for other various reasons. As such, we compliance with dose limits and outcome measure related to RT care, believe that these measures would not radiation exposure; hospice referrals; with some commenters noting that an meaningfully indicate high- versus low- and innovation in patient care outcome measure is preferred for an quality RO participants. As stated in the management (for example, phone and Advanced APM. proposed rule (84 FR 34514), while we email contact). Other commenters Some commenters believe that an believe it is preferable to include an recommended that CMS consider outcome measure is important for the outcome measure in an Advanced APM, quality measures supported by ASTRO, Model to evaluate whether a high level there are currently no outcome including: Cancer Stage Documented; of care quality is maintained throughout measures specific to RO available for External Beam Radiotherapy for Bone the Model performance period, with a implementation. We appreciate Metastases; Hormonal Therapy for Stage commenter requesting an outcome commenters’ suggestions for IC–IIIC; ER/PR Positive Breast Cancer; measure specifically to ensure that understanding outcomes related to care Adjuvant Hormonal Therapy for High- hypofractionation does not cause harm. delivered under the RO Model, Risk Patients; and Chemotherapy for A commenter recommended that quality including the suggestion that CMS use AJCC Stage III Colon Cancer Patients. A programs should have outcome, patient QCDRs to track outcomes. We will commenter recommended that CMS experience, and value measures. On the monitor the progress in this area but communicate a commitment to adopt topic of outcome measure development, note that Professional participants and clinical and staging measures by PY2. several commenters suggested that CMS Dual participants are not required to Another commenter requested CMS collaborate with professional and contract with a QCDR; thus we will not develop a process to accept specialty societies to identify metrics use these entities as a means of recommendations of potential measures that meaningfully measure quality of collecting outcome measures. We will to be considered for implementation in cancer care and impact on outcomes continue to assess and consider the RO Model. (including survival). A commenter also advancements made by professional and Response: We appreciate the recommended that CMS track patient specialty societies in the development suggestions of additional quality outcomes via a Medicare-certified of quality metrics to identify the measures. As previously discussed, we Qualified Clinical Data Registry (QCDR). availability of metrics that meaningfully proposed the four measures and the Another commenter recommended measure quality of RT care and impact CAHPS® Cancer Care survey described using a clinical outcomes measures on outcomes (including survival). As in the proposed rule for PY1 because we related to patient safety (including the these are identified, we will consider believe these measures will allow us to incidence of various side effects that proposing an appropriate outcome monitor and evaluate quality in the may accompany overexposure of measure in future rulemaking.

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Comment: A commenter quality measures that reflect variation in these requirements, but we note that recommended developing an outcome accreditation and equipment used for three of the four proposed quality registry for incidents such as bone treatment. measures are already included in the marrow transplants, CAR–T cell Response: We appreciate the role of MIPS program, so we expect that some therapy, fractures, pain, high-quality equipment in the delivery of these measures may already be hospitalizations, and other of care. We also understand that to familiar to EHR vendors. In regard to complications. Another commenter achieve accreditation, a clinical small and rural providers and suppliers, encouraged CMS to develop a central organization must demonstrate high please see section III.C.3.c of this final reporting mechanism for patients standards of patient care. We also note rule, which outlines the opt-out option receiving relatively new, relatively that, as discussed in section III.C.13.c, for low-volume providers and suppliers. expensive technologies and their we may request the optional submission Comment: A few commenters outcomes. of additional administrative data opposed the implementation of quality Response: CMS is not developing a through web-based surveys, such as measures in the RO Model and registry for use in the RO Model, but we how frequently the radiation machine is suggested not implementing quality appreciate this comment and used on an average day and the RO measures in the Model at all, stating acknowledge the value of registries to participant’s accreditation status. their view that the measures would not track treatment effects and health However, we continue to believe that yield information reflective of quality in outcomes, while not increasing data quality measurement must be outcome- a radiation oncology practice and would collection burden for providers and based, focusing on the patient and the do little to encourage actual suppliers. We will monitor registry episode of care, and not be based solely improvement in the quality of patient development and assess the feasibility on the equipment or accreditation care. of using such registry data in the future. status. We will use clinical data Response: We disagree with Comment: A commenter urged CMS elements in the RO Model to support commenters’ assertions regarding the to consider the relationship between the monitoring and evaluation of the Model impact of quality measurement in the 90-day episode period and the timing and may use these data to begin RO Model. We believe that including included in the RO Model’s measure developing new outcome-based quality appropriate quality measures in the RO specifications, and requested CMS measures that may capture the effect of Model—as in other Innovation Center properly scope the measures to reflect quality equipment and infrastructure. Alternative Payment Models (APMs)—is care that is within the control of the Comment: Several commenters critical to monitoring beneficiary care radiation oncologist specifically within recommended a voluntary phase-in and ensuring that quality of care is the 90-day episode window. period to collect quality measure data, preserved or enhanced within an Response: We believe that the which they believe would allow episode payment model in which CMS measures we are adopting are practices to become operational within expenditures are reduced. Quality appropriate for inclusion in the RO the Model and provide better data. A measures are in alignment with the CMS Model. We selected all measures based couple of commenters urged CMS to and Innovation Center goals of on clinical appropriateness for RT provide additional details on quality providing effective, safe, efficient, services spanning a 90-day episode measure and clinical data element patient-centered, equitable, and timely period. The measures are scoped to collection and submission processes to care. Furthermore, if we did not finalize certain specifications, including time, give RO participants additional time to quality measures for the RO Model, it which are important for validity and prepare their systems and comply with would not satisfy the requirements of an reliability of the measure results. We these requirements. Advanced APM, nor a MIPS APM. believe that radiation oncologists have Response: We do not believe a ® an important role to play in ensuring voluntary phase-in period is necessary b. RO Model Measures and CAHPS that their patients have a plan to address for the RO Model. RO participants’ first Cancer Care Survey for Radiation beneficiary pain, that they communicate submission for the set of quality Therapy treatment with other providers and measures for PY1 (beginning on January As we discussed in the proposed rule suppliers to ensure the RO beneficiaries 1, 2021) as described in section III.C.8.b (84 FR 34515), we selected the four are receiving coordinated care, and that will begin in March 2022, as finalized quality measures for the RO Model after they have been screened for depression in section III.C.8.c. We believe conducting a comprehensive and have an advance care plan. By beginning the Model performance environmental scan that included encouraging radiation oncologists to period on January 1, 2021 Model will stakeholder and clinician input and provide guidance and care coordination allow RO participants to review and to compiling a measure inventory. Three of as well as engage with patients develop best practices to facilitate their the four measures are currently NQF- throughout their treatments, we believe data collection and to work with EHR endorsed 48 process measures approved these measures will improve both vendors to seek additional EHR support. for MIPS.49 We proposed for the three patients’ outcomes and their experience We will provide additional information NQF-endorsed measures approved for of care. We believe both depression about measure collection on the RO MIPS (Plan of Care for Pain; Screening screening and advance care planning Model website: https:// for Depression and Follow-Up Plan; and help RO beneficiaries ensure they are innovation.cms.gov/initiatives/ Advance Care Plan) to be applied as engaged and pursuing the best course of radiation-oncology-model/. pay-for-performance, given that baseline treatment for them. Comment: A commenter expressed performance data has been Comment: A commenter expressed concern that EHR vendors will use the established.50 The fourth measure in the concern that the proposed quality new requirements to generate additional measures are insufficient to measure fees for their products, thereby placing 48 NQF endorsement summaries: http:// whether RO participants are using high- RO participants, especially those that www.qualityforum.org/News_And_Resources/ Endorsement_Summaries/Endorsement_ quality equipment and other are small and rural, at greater financial Summaries.aspx. infrastructure they believe correlate risk. 49 See the CY 2018 QPP final rule (82 FR 53568). with providing high-value care. This Response: We understand the 50 Baseline performance is based on the entirety commenter recommended including commenter’s concern about the cost of of data submitted to meet MIPS data reporting

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RO Model (Treatment Summary with advanced disease.’’ 53 Proper pain associated specifications available Communication) would be applied as management is critical to achieving pain beginning in PY1. This measure would pay-for-reporting until such time that a control. This measure aims to improve be a pay-for-performance measure and benchmark can be developed, which is attention to pain management and scored in accordance with our expected to be PY3, as discussed in requires a plan of care for cancer methodology in section III.C.8.f of this section III.C.8.b of the proposed rule (84 patients who report having pain to final rule. FR 34515) and this final rule. As allow for individualized treatment. As proposed (84 FR 34517), and as described in the proposed rule, all four As we noted in the proposed rule (84 discussed further in section III.C.8.c of measures are clinically appropriate for FR 34515), we believe this measure is this final rule, we would require radiation oncology and were selected appropriate for inclusion in the RO Professional participants and Dual based on clinical appropriateness to Model because it is specific to an participants to report quality measure cover RT spanning the 90-day episode episode of care. It considers the quality data to the RO Model secure data portal period. These measures ensure coverage of care of medical and radiation in the manner consistent with that across the full range of cancer types oncology and is NQF-endorsed. As we submission portal and the measure included in the RO Model, and provide proposed, the RO Model would adopt specification. At the time of the us the ability to accurately measure the measure according to the most proposed rule and at the time of the changes or improvements related to the recent specifications, which are under writing of the final rule, the current Model’s aims. In addition, we proposed review at NQF in Fall 2019 (and as of version of the Plan of Care for Pain the CAHPS® Cancer Care survey to the drafting of this final rule are still measure specification requires that data collect information we believe is under review). The current measure will be reported for the performance appropriate and specific to a patient’s specifications are being used for year that covers the date of encounter. experience during an episode. We noted payment determination within the PPS- The measure numerator includes patient in the proposed rule that we believe Exempt Cancer Hospital Quality visits that included a documented plan ® these measures and the CAHPS Cancer Reporting (PCHQR) Program (beginning of care to address pain. The measure Care survey 51 will allow the RO Model in FY2016 as PCH–15), the Oncology denominator includes all visits for to develop an Aggregate Quality Score Care Model (OCM) (beginning in 2016 patients, regardless of age, with a (AQS) in our pay-for-performance as a component of OCM–4), and the diagnosis of cancer currently receiving methodology (described in section Merit-Based Incentive Payment System chemotherapy or radiation therapy who III.C.8.f of this final rule) that (MIPS) (beginning in CY2017 as CMS report having pain. Any exclusions can incorporates performance measurement #144). We explained in the proposed be found in the detailed measure with a focus on clinical care and patient rule that as long as the measure remains specification linked in this section of experience. reliable and relevant to the RO Model’s this final rule. goals, we would continue to include the (1) Oncology: Medical and Radiation— For the RO Model, we proposed to use measure in the Model regardless of the CQM 54 specifications for this Plan of Care for Pain (NQF #0383; CMS whether or not the measure is used in Quality ID #144) measure. Detailed measure other CMS programs. If in the future we specifications may be found at: https:// We proposed the Oncology: Medical believe it necessary to remove the qpp.cms.gov/docs/QPP_quality_ and Radiation—Plan of Care for Pain measure from the RO Model, then we measure_specifications/CQM-Measures/ (‘‘Plan of Care for Pain’’) measure in the will propose to do so through notice and 2020_Measure_144_MIPSCQM.pdf. RO Model (84 FR 34515). This is a comment rulemaking. The following is a summary of the process measure that assesses whether a We noted in the proposed rule that public comments received on this plan of care for pain has been this measure was currently undergoing proposal and our response: documented for patients with cancer triennial review for NQF endorsement Comment: A few commenters who report having pain. This measure via the NQF’s Fall 2019 Cycle and while expressed support for implementing the assesses the ‘‘[p]ercentage of patients, we expected changes to the measure Plan of Care for Pain measure, believing regardless of age, with a diagnosis of specifications, we did not believe these that the assessment reflected by this cancer who are currently receiving changes would change the fundamental measure will improve the quality of chemotherapy or RT that have moderate basis of the measure, nor did we believe patient care. A commenter asked CMMI or severe pain for which there is a they would impact the measure’s to clarify the measure specification that documented plan of care to address pain appropriateness for inclusion in the RO would be used beginning in 2020, in the first two visits.’’ 52 As stated in Model. As of the drafting of this final noting the specifications were changed the FY 2014 IPPS/LTCH PPS final rule rule, this measure is still under NQF for the 2019 MIPS performance year, but (78 FR 50843), pain is the most common review, but as we explained in the the measure steward is reverting to the symptom in cancer, occurring ‘‘in proposed rule, NQF endorsement is a approximately one quarter of patients factor in our decision to implement the 2018 specifications (to include those with newly diagnosed malignancies, Plan of Care for Pain measure, but it is who report all pain, versus the 2019 one third of patients undergoing not the only factor. If the measure were specifications that only included reports treatment, and three quarters of patients to lose its NQF endorsement, we noted of moderate or severe pain). in the proposed rule that we may choose Response: We agree that this measure reflects an important area of assessment. requirements for these measures and are not to retain it so long as we believe it specific to radiation oncology performance. continues to support CMS and HHS We also note that where one measure is 51 As discussed in section III.C.8.b(5) and III.C.8.f, policy goals. Therefore, we proposed the being used in multiple CMS programs, the CAHPS® Cancer Care survey would be Plan of Care for Pain measure with the we seek to align measure specifications administered beginning in October, 2020, and we across programs and use the most up-to- would seek to include measures in the aggregate quality score beginning in PY3. 53 Swarm RA, Abernethy AP, Anghelescu DL, et date version as appropriate. As 52 Oncology: Medical and Radiation—Plan of Care al. Adult Cancer Pain: Clinical Practice Guidelines for Pain. American Society of Clinical Oncology. In in Oncology. Journal of the National 54 We note that we proposed to use ‘‘registry Review for Maintenance of Endorsement by the Comprehensive Cancer Network: JNCCN. specifications.’’ For consistency with QPP, we are National Quality Forum (NQF #0383). Last 2013;11(8):992–1022. Available at: https:// now referring to registry specifications as CQM Updated: June 26, 2018. www.ncbi.nlm.nih.gov/pmc/articles/PMC5915297/. specifications to align with QPP’s terminology.

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discussed in section III.C.8.d, measures We noted that this measure has been The following is a summary of the also undergo non-substantive technical used for payment determination within public comments received on this maintenance and we intend to use the OCM (beginning in 2016 as OCM–5) and proposal and our response: most recent specifications unless those MIPS (beginning in CY2018 as CMS Comment: A few commenters specifications are inconsistent with the #134) and is NQF endorsed. We also supported this measure. A commenter specifications used in MIPS. In those indicated that if we were to remove the asserted the measure should be situations, we would use the MIPS measure from the RO Model, we would broadened to include screening for specifications. Thus, for each PY, we use notice and comment in rulemaking. distress (for example, anxiety, stress, will utilize the specifications of the As proposed, this measure would be a and social isolation) and whether measure that aligns with the most recent pay-for-performance measure beginning follow-up care is being sought. Another MIPS year specifications.55 in PY1 and scored in accordance with commenter who supported the measure After consideration of the comments our methodology described in section recommended an exception be written we received, we are finalizing as III.C.8.f of this final rule. into the specifications to exclude proposed to include the Oncology: As noted in the proposed rule, patients who were screened less than Medical and Radiation—Plan of Care for discussed further in section III.C.8.c of six months prior to the encounter Pain (NQF #0383; CMS Quality ID #144) this final rule, we would require within the measurement period. The Measure as a pay-for-performance Professional participants and Dual commenter explained that this measure beginning in PY1. participants to report quality measure exception could be utilized to guard against the perception of gaming that (2) Preventive Care and Screening: data to the RO Model secure data portal the commenter believes exists in OCM Screening for Depression and Follow- in the manner consistent with that practices that are screening patients for Up Plan (NQF #0418; CMS Quality ID submission portal and the measure depression on a quarterly (or more #134) specification. The Screening for Depression and Follow-Up Plan frequent) basis, to perform better on the We proposed the Preventive Care and measure specification states the data measure. This commenter also noted Screening: Screening for Depression and will be reported for the performance that the frequency of screening places Follow-Up Plan (‘‘Screening for year that covers the date of encounter. burden on patients. Depression and Follow-Up Plan’’) The measure numerator includes Response: We appreciate commenters’ measure in the RO Model (84 FR 34516). support for including this measure in patients screened for depression on the This is a process measure that assesses the Model. We respect the commenter’s date of the encounter using an age- the ‘‘[p]ercentage of patients screened concerns regarding the perception of appropriate standardized tool and, if the for clinical depression with an age- gaming as related to this measure. While screening is positive, a follow-up plan is appropriate, standardized tool and who we understand the importance of documented on the date of the positive have had a follow-up care plan mitigating gaming, we do not concur screen. The measure denominator documented in the medical record.’’ 56 with the commenter’s perception of includes all patients aged 12 years and As we noted in the proposed rule, we gaming in OCM practices. CMS is not older before the beginning of the believe this clinical topic is appropriate the measure steward, however, we will measurement period with at least one for an episode of care even though it is share the commenters’ feedback on not specific to RT. We explained that we eligible encounter during the potential changes to the specifications believe inclusion of this measure is measurement period. Any exclusions with the measure steward for desirable to screen and treat the can be found in the detailed measure consideration especially with respect in potential mental health effects of RT, specification linked in this section in recognition of the perception of gaming. which is important because some of the this final rule. Comment: A few commenters side effects of RT have been identified For the RO Model, we would use the recommended against adopting this as having a detrimental effect on a CQM 63 specifications for this measure. measure, noting that (1) it is considered patient’s quality of life and could Detailed measure specifications may be topped-out; (2) it is outside of the direct potentially impact the patient beyond found at: https://qpp.cms.gov/docs/ control of radiation oncologists (that is, _ _ _ physical discomfort or pain.57 58 59 60 61 62 QPP quality measure specifications/ typically the responsibility of primary CQM-Measures/2020_Measure_134_ care physicians or medical oncologists), 55 We intend to align with the most recent MIPS MIPSCQM.pdf. and therefore not directly applicable to year specifications for each measure that is the RO Model; and (3) calculating the included in MIPS because such alignment will Management of Depression in Patients With Cancer: reduce burden for RO participants and permit measure imposes a burden on providers A Clinical Practice Guideline. Journal of Oncology comparisons between the MIPS and RO and suppliers because the data is not participants. Practice, 12(8), 747–756. https://ascopubs.org/doi/ 10.1200/JOP.2016.011072. captured in a discrete field in the 56 Preventive Care and Screening: Screening for 60 medical record. These commenters Depression and Follow-Up Plan. Centers for Pinquart, M., & Duberstein, P.R. (2010). Medicare & Medicaid Services. Endorsed by the Depression and cancer mortality: A meta-analysis. suggested that CMS work with specialty National Quality Forum (NQF #0418). Last Psychological Medicine, 40(11), 1797–1810. societies, radiation oncologists, and Updated: Jun 28, 2017. doi:10.1017/s0033291709992285, https:// other stakeholders to develop and pubmed.ncbi.nlm.nih.gov/20085667/. 57 Siu AL, and the U.S. Preventive Services Task validate appropriate measures for Force USPSTF. Screening for Depression in Adults: 61 Massie, M.J. (2004). Prevalence of Depression U.S. Preventive Services Task Force in Patients With Cancer. Journal of the National radiation therapy. Recommendation Statement. JAMA. Cancer Institute Monographs, 2004(32), 57–71. Response: We appreciate all of the 2016;315(4):380–387. doi:10.1001/jama.2015.18392, https://doi.org/10.1093/jncimonographs/lgh014. comments regarding this measure and https://jamanetwork.com/journals/jama/fullarticle/ 62 Linden, W., Vodermaier, A., Mackenzie, R., & acknowledge the concerns that some 2484345. Greig, D. (2012). Anxiety and depression after 58 Meijer, A., Roseman, M., Milette, K., Coyne, cancer diagnosis: Prevalence rates by cancer type, commenters expressed. The RO Model J.C., Stefanek, M.E., Ziegelstein, R.C., . . . Thombs, gender, and age. Journal of Affective Disorders, will use the MIPS CQM version of this B.D. (2011). Depression screening and patient 141(2–3), 343–351. doi:10.1016/j.jad.2012.03.025, measure. For providers and suppliers outcomes in cancer: A systematic review. PloS one, https://pubmed.ncbi.nlm.nih.gov/22727334/. that participated in MIPS and submitted 6(11), e27181. https://doi.org/10.1371/ 63 We note that we proposed to use ‘‘registry journal.pone.0027181. specifications.’’ For consistency with QPP, we are the measure through the MIPS CQM, 59 Li, M., Kennedy, E.B., Byrne, N., Ge´rin-Lajoie, now referring to registry specifications as CQM this measure is not topped-out. Further, C., Katz, M.R., Keshavarz, H., . . . Green, E. (2016). specifications to align with QPP’s terminology. even if this measure were to become

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topped-out for the population of (3) Advance Care Plan (NQF #0326; measure specification linked in this providers and suppliers who participate CMS Quality ID #047) section of this final rule. in MIPS, there is value to implementing As proposed, for the RO Model, we We proposed to include the Advance measures that have topped-out in order would use the CQM 65 specifications for Care Plan measure in the RO Model (84 to prevent a decrease in performance on this measure. Detailed measure FR 34517). The Advance Care Plan this aspect of care. Further, establishing specifications may be found at: https:// measure is a process measure that continuity in the quality measures qpp.cms.gov/docs/QPP_quality_ describes percentage of patients aged 65 implemented in the RO Model and measure_specifications/CQM-Measures/ years and older that have an advance MIPS will be a key factor in our 2020_Measure_047_MIPSCQM.pdf. care plan or surrogate decision maker assessment of the RO Model’s The following is a summary of the documented in the medical record or performance over time, as it will allow public comments received on this documentation in the medical record for data comparison between the proposal and our response: that an advance care plan was discussed participating entities in each respective Comment: A few commenters but the patient did not wish or was not program. While screening for depression supported implementing the Advance able to name a surrogate decision maker and follow-up care is not traditionally Care Plan measure. A commenter noted or provide an advance care plan. This within the purview of radiation advance care planning is associated measure is not unique to the radiation oncologists, we believe the RO Model with lower rates of ventilation, oncology, but, as proposed, we believe presents an opportunity to address the resuscitation, intensive care unit that it would be appropriate for the RO need for more comprehensive admission, earlier hospice enrollment, Model because we believe that it is understanding of patients’ health when and decreased cost of care at the end of essential that a patient’s wishes undergoing RT services. Care can be life. Another commenter noted advance regarding medical treatment are delivered more effectively when RO care planning is a key activity in cancer established as much as possible prior to participants understand their patients’ care planning and documenting a incapacity. patient’s goals and values can result in mental health, and the ramifications of 64 their mental health on their care This measure is NQF endorsed and more personalized care plans. Finally, a planning and care delivery. Specifically, has been collected for MIPS (beginning commenter supported this measure but we note this measure requires that a in CY2018 as CMS #047), making its recommended allowing an exclusion for follow-up plan is documented on the data collection processes reasonably those patients who do not want to day of a positive screening. In regard to well established. If it becomes necessary participate in advance care planning. provider and supplier burden, we to remove the measure from the Model, Response: We thank the commenters expect that—given this is an existing we would do so through notice and for their support. Regarding the MIPS measure—data are captured in comment rulemaking. As proposed, this comment to exclude patients who do EHRs, and/or EHR vendors will have measure would be a pay-for- not want to participate in advance care capacity to establish needed collection performance measure beginning in PY1 planning, we are implementing the fields. We will continue to monitor our and scored in accordance with our measure using the current measure set and other measures as they methodology in section III.C.8.f of this specifications, which have been tested become available to ensure the RO rule. and validated for reliability. We note Model measure set remains appropriate, As proposed (84 FR 34517), and as that within the current specifications, meaningful and parsimonious. discussed further in section III.C.8.c of the numerator captures how many Comment: A commenter this rule, we would require Professional patients were asked if they have an recommended categorizing this measure participants and Dual participants to advance care plan and is agnostic as to as pay-for-reporting in the AQS report quality measure data the RO whether or not they have a plan. Thus, methodology (as opposed to pay-for- Model secure data portal in the manner an exclusion for those patients who performance) until a benchmark is consistent with that submission portal chose not to have such a plan is not established specific to radiation and the measure specification. The necessary to performance on this oncology patients, noting that the current version (at the time of the measure. current MIPS benchmark for this proposed rule and the drafting of this Comment: A few commenters measure would create an inappropriate final rule) of the Advance Care Plan recommended not finalizing the cohort comparison. measure specification states the data Advance Care Plan measure, because Response: We believe that setting will be reported for the performance they believe: (1) It is topped-out; (2) it discrete benchmarks for different year that covers the date of is outside the direct control of radiation specialties does not align with CMS’ documentation in the medical record. oncologists; (3) calculating the measure goals for quality improvement. In The measure numerator includes imposes a substantial burden on RO addition, discrete benchmarks would patients who have an advance care plan participants; and (4). this measure does create undue complexity and possible or surrogate decision maker not account for patients’ receipt of confusion for RO participants who also documented in the medical record or survivorship care plans and may create participate in MIPS to have potentially documentation in the medical record duplication of effort. two different benchmarks. Therefore, we that an advance care plan was discussed Response: We appreciate all of the will use the MIPS benchmark and but patient did not wish or was not able comments regarding this measure and finalize this measure as Pay-for- to name a surrogate decision maker or acknowledge the concerns that some Performance in PY1. provide an advance care plan. The commenters expressed. As we stated in measure denominator includes all After consideration of the comments our discussion of the Screening for patients aged 65 years and older. Any we received, we are finalizing the Depression and Follow-Up Plan exclusions can be found in the detailed proposal to include the Preventive Care measure, we are using the MIPS CQM and Screening: Screening for Depression 64 As of April 2020 this measure is undergoing an 65 We note that we proposed to use ‘‘registry and Follow-Up Plan (NQF #0418; CMS annual endorsement update review at NQF. A specifications.’’ For consistency with QPP, we are Quality ID #134) Measure as a pay-for- modified specification was submitted for review by now referring to registry specifications as CQM performance measure beginning in PY1. the measure developer. specifications to align with QPP’s terminology.

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version of this measure. This measure is summary report in the chart that was specification linked in this section of not topped-out for the population of communicated to the physician(s) this final rule. providers and suppliers who participate providing continuing care and to the For the RO Model, we would use the in MIPS and submitted their data patient within one month of completing registry specifications for this measure. through the MIPS CQM. There is also treatment.’’ 67 As proposed, we believe Detailed measure specifications may be value to implementing measures that this measure is appropriate for inclusion found at: http://www.qualityforum.org/ have topped-out, to prevent a decrease in the RO Model because it is specific QPS/0381. in performance on this aspect of care. to an episode of care. This measure The following is a summary of the While advance care planning may not assesses care coordination and public comments received on this be traditionally within the purview of communication between health care proposal and our response: radiation oncologists, we believe the providers during transitions of cancer Comment: A few commenters Model presents an opportunity for RO care treatment and recovery. While this expressed support for the measure Treatment Summary Communication. A participants to engage patients in care measure is not currently NQF couple of commenters noted their desire planning. Further, establishing endorsed 68 and has not been used in for CMS to collect data beyond what continuity in the quality measures previous or current CMS quality this measure captures, and look at implemented in the RO Model and reporting, it has been used in the multidisciplinary treatment planning MIPS will be a key factor in our oncology field for quality improvement efforts across radiation oncology, assessment of the RO Model’s efforts, making considerations regarding performance over time, as it will allow surgery, and medical oncology. A data collection reasonably well- couple of commenters expressed for data comparison between the established. We would include the participating entities in each respective support for implementing this measure measure because, as we stated in the as pay-for-reporting in PYs 1–2 and program. In regard to provider and proposed rule, we believe it is valid and supplier burden, we expect that—given encouraged CMS to test the measure for relevant to meeting the RO Model’s reliability and validity, and provide this is an existing MIPS measure—data goals. As proposed, this measure would are captured in EHRs, and/or EHR additional information to RO be the one pay-for reporting measure participants, before transitioning it to a vendors will have capacity to establish included in the calculation of the AQS needed collection fields. Finally, we pay-for-performance measure. until a benchmark is established that Response: We appreciate commenters’ seek to clarify that the Advance Care will enable it to be pay-for-performance, support and are finalizing this measure, Plan measure quantifies the number of which is expected to be beginning in using the current specifications, which patients who have an advance care plan PY3. have been tested and validated for or a surrogate decision-maker reliability, in the RO Model as described documented in the medical record, or As proposed (84 FR 34517), and as in the proposed rule: Pay-for-reporting documentation that an advance care discussed further in section III.C.8.c of this final rule, we would require in PY1 and PY2; and pay-for- plan was discussed but the patient did performance in PYs 3–5. We believe the not wish or was not able to name a Professional participants and Dual participants to report quality measure measure must be pay-for-reporting in surrogate. We do not see any overlap PY1 and PY2 in order to establish between this measure, and the process data to the RO Model secure data portal in the manner consistent with that historical data to set a benchmark for of providers and suppliers working with use during the pay-for-performance patients to develop Survivorship Care submission portal and the measure specification. The current version (at the years. We plan to provide information Plans. Survivorship Care Plans include regarding the benchmark for the information about a patient’s treatment, time of the proposed rule and the drafting of this final rule) of the measure Treatment Summary the need for future check-ups and Communication to RO participants via cancer tests, and potential long-term late Treatment Summary Communication measure specification states the data the RO Model website. effects of treatment, as well as ideas for Comment: A few commenters 66 will be reported for the performance health improvement. expressed concerns regarding the After consideration of the comments year that covers the date of the specifications and/or endorsement we received, we are finalizing as treatment summary report in the chart. status of this measure. A commenter proposed to include the Advance Care The measure numerator includes specifically noted the measure was Plan (NQF #0326; CMS Quality ID #047) patients who have a treatment summary withdrawn from NQF consideration by Measure as a pay-for-performance report in the chart that was the developer, and not submitted for measure beginning in PY1. communicated to the physician(s) NQF measure maintenance evaluation, providing continuing care and to the (4) Treatment Summary thus it is no longer endorsed. patient within one month of completing Communication—Radiation Oncology Commenters noted that the lack of treatment. The measure denominator endorsed measure specifications can We proposed the Treatment Summary includes all patients, regardless of age, create inconsistency in how the measure Communication—Radiation Oncology with a diagnosis of cancer who have is utilized; they also noted that this (‘‘Treatment Summary undergone brachytherapy or external measure is not widely integrated into Communication’’) measure in the RO beam radiation therapy. Any exclusions EHRs, thus creating burden for RO Model (84 FR 34517). The Treatment can be found in the detailed measure participants who will need to integrate Summary Communication measure is a the measure’s data points into their process measure that assesses the 67 Oncology: Treatment Summary EHRs. Another commenter noted that ‘‘[p]ercentage of patients, regardless of Communication—Radiation Oncology. American the measures should be implemented age, with a diagnosis of cancer that have Society for Radiation Oncology. Endorsement with the original specifications to undergone brachytherapy or external removed by the National Quality Forum (NQF #0381). Last Updated: Mar 22, 2018. document treatment summary beam RT who have a treatment 68 Treatment Summary Communication had communications that take place over a previously been endorsed by NQF but was not four-week period of a patient’s care and 66 https://www.cancer.net/survivorship/follow- brought by the measure steward for measure care-after-cancer-treatment/asco-cancer-treatment- maintenance and re-endorsement; thus it is recommended that CMS align how this and-survivorship-care-plans. currently not endorsed. measure’s data is collected and

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reported—using the original four-week shift toward incorporation of patient benchmarks would make it difficult to specification—across all CMS reporting experience into quality measurement incorporate the measure into the AQS at programs. and pay-for-performance programs. PY3, and recommended delaying until Response: We appreciate commenters’ Variations of the CAHPS® survey have PY4. A third commenter suggested CMS concerns and will finalize the measure been used within the PCHQR Program, pilot the CAHPS® Cancer Care Survey specifications as proposed. Where one Hospital OQR Program, MIPS, OCM, before including it as a measure in the measure is being used in multiple CMS and others, making considerations AQS. Some commenters did not support programs or models, we seek to align regarding data collection reasonably adopting the CAHPS® Cancer Care measure specifications across programs well-established. Survey because they believe that it does and models and use the most up-to-date As we indicated in the proposed rule, not elicit meaningful data from patients. version as appropriate. Regarding NQF we plan to propose a set of patient The commenters argued that: (1) The endorsement, we agree that NQF experience domains based on the time lag between when a patient endorsement is an important, but not CAHPS® Cancer Care Survey, which finishes a course of radiotherapy and the sole, criterion for identifying would be included in the AQS as pay- when they receive the CAHPS® Cancer measures for implementation. RO for-performance measures beginning in Care Survey makes it challenging to participants will be provided with PY3, in future rulemaking. remember the specifics of their care educational materials that provide the The CAHPS® Cancer Care Survey experience; (2) the multi-disciplinary specification details for each measure, proposed for inclusion in the RO Model nature of oncology care, including RT which addresses the concerns expressed may be found at https://www.ahrq.gov/ services, makes it difficult for patients by commenters that lack of current NQF cahps/surveys-guidance/cancer/ to tease out their specific RT experience; endorsement may lead to inconsistency index.html. (3) the length of the survey and current in how the measure is operationalized We solicited public comment on our administration modes (by mail or ® within the RO Model. proposal to administer the CAHPS telephone, with no electronic option) is Comment: A commenter requested Cancer Care Survey for Radiation overwhelming to patients; (4) the mail clarification about how this measure Therapy for purposes of testing the RO or phone nature of fielding CAHPS® has would be fielded. Another commenter Model. the potential to be viewed by patients as requested clarification that RO Comment: A couple of commenters a scam; and (5) the burden on patients participants do not need to send a recommended CMS implement the who have to fill out multiple surveys, ® treatment summary to other PGPs if CAHPS Cancer Care Survey in the which may create timing issues for RO both have access to the same EHR. Model earlier than PY3 due to the participants to comply with RO Model Response: The intent of this measure importance of collecting patient deadlines. is to ensure that the radiation oncology experience data to inform clinical care. Response: We acknowledge there are treatment documentation is Response: We appreciate commenter’s significant challenges to implementing appropriately transitioned to the recommendations and agree with patient experience measures in any physician responsible for the patient’s sentiment that collecting patient model or program; however, those ongoing care, as well as to the patient, experience data is critical. We will challenges should not preclude making to ensure safe and timely care begin fielding the CAHPS® Cancer Care the effort to collect and analyze data on coordination and care continuity post- Survey in PY1. The inclusion of patient the patient experience, to achieve the treatment. If the referring PGP and RO experience measures in the calculation ultimate goal of improving patient care. participant are using the same EHR, of the AQS will not begin until PY3, We note that AHRQ has tested the appropriate communication must still after future rulemaking, due to the time survey for reliability and validity to occur with the patient, and referring needed to derive and test which address issues of comparability across PGP as appropriate, in order to meet the domains should be included in the AQS practices and patient characteristics. As criteria for the measure numerator. using data collected from the early years such, we do not believe it is necessary After consideration of the comments of the Model. to implement a pilot period prior to we received, we are finalizing as Comment: A few commenters including this survey as a part of the proposed to include the Treatment requested clarification regarding who AQS. Further, we reiterate that the Summary Communication—Radiation would administer the CAHPS® Cancer CAHPS® Cancer Care Survey be fielded Oncology as a pay-for-reporting measure Care Survey. These commenters also starting in PY1 but not included in the beginning in PY1. expressed concern that the RO AQS methodology as a pay-for-reporting participant would have to bear the (5) CAHPS® Cancer Care Survey for measure until PY3, after future administrative and financial cost of rulemaking. Finally, we do not believe Radiation Therapy fielding the survey. a delay in implementation to help RO We proposed to have a CMS-approved Response: We would like to clarify participants prepare for fielding the ® contractor administer the CAHPS that CMS will be accountable for survey is needed, given that CMS will Cancer Care Survey for Radiation fielding the CAHPS® Cancer Care administer the survey. Therapy (‘‘CAHPS® Cancer Care Survey to RO beneficiaries. RO Comment: Some commenters Survey’’), beginning April 1, 2020 and participants should not experience any expressed concern with the use of the ending in 2025, to account for episodes additional cost as a result of CAHPS® Cancer Care Survey for other that were completed in the last quarter implementation of the survey. methodological reasons, including: (1) of 2024 (84 FR 32517). We would use Comment: Several commenters did The survey is not endorsed by NQF; (2) the CAHPS® Cancer Care Survey for not support adopting, or recommended lack of sufficient testing of the survey to inclusion in the Model as it is delaying implementation of, the ensure comparability of performance appropriate and specific to patient CAHPS® Cancer Care Survey. A scores based on practice size and type, experience of care within an RO commenter asserted the timing of patient characteristics, and/or episode. Variations of the CAHPS® implementation of the RO Model would geographic regions; (3) the need to survey are widely used measures of not allow participants enough time to harmonize the survey with the CAHPS® patient satisfaction and experience of prepare for fielding the survey. Another Hospice survey; (4) the lack of a strategy care and are responsive to the increasing commenter stated the lack of current for ensuring that RO beneficiaries do not

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receive both surveys during what is Cancer Care Survey that will be used measure data, instead of beneficiary- already a stressful and anxious time; (5) was specifically developed for radiation level quality measure data. These data inherent biases against HOPDs that may therapy, which we believe addresses the would be used to calculate the be found in patient experience surveys, commenter’s concern about being able participants’ quality performance, as due to HOPDs often having fewer to appropriately consider RT care discussed in section III.C.8.f(1) of the resources for staffing, capital, and experiences. proposed rule (84 FR 34519) and this amenities compared to PGPs and free Comment: A few commenters final rule, and subsequent quality standing radiation therapy centers, suggested creating a new patient reconciliation payments on an annual which may correlate with lower patient experience measure to replace the use of basis. experience scores; and (6) potential the CAHPS® Cancer Care Survey. A Second, we proposed requiring that overlap in the CAHPS® Cancer Care commenter suggested that the patient quality measure data be reported for all Survey and the Outpatient and experience measure should be applicable patients (that is, not just Ambulatory Surgery (OAS) CAHPS® developed in a way that eliminates bias Medicare beneficiaries or beneficiaries survey, which could negatively affecting against HOPDs, which the commenter with episodes under the Model) based response rates for either or both says often have a less favorable payer on the numerator and denominator survey(s). A commenter recommended mix than PGPs and freestanding specifications for each measure (84 FR that CMS investigate electronic modes radiation therapy centers. Another 34517). As proposed, we believe of fielding the CAHPS® Cancer Care commenter noted that while patient collecting data for all patients who meet Survey. experience measures are good indicators the denominator specifications for each Response: We appreciate commenters of whether and how changes are being measure from a Professional participant sharing their methodological concerns implemented in care, an actual patient or Dual participant, and not just and acknowledge that collecting patient experience measure that reflects the RO Medicare beneficiaries, is appropriate experience data is a challenging effort. Model should be developed at an because it is consistent with the We will consider these comments as we accelerated pace. applicable measure specifications, and implement the Model and begin Response: We agree that innovation in any segmentation to solely the Medicare reviewing the survey data, and where the collection of patient experience data populations would be inconsistent with necessary, we will seek to address them is important to pursue, and we welcome the measure and add substantial in future rulemaking. Regarding NQF advancements in this area. However, we reporting burden to RO participants. If endorsement, we agree that NQF also believe that the need to understand a measure is already reported in another endorsement is an important, but not patients’ experiences of care is critical, program, then the measure data would the sole, criterion for identifying and cannot be delayed while other be submitted to that program’s reporting measures for implementation. Regarding measures are being developed. For these mechanism in a form, manner, and at a testing the survey in the Model, AHRQ reasons, we are finalizing adoption of time consistent with the other program’s ® has tested the survey for reliability and the CAHPS Cancer Care Survey and requirements, and separately submitted validity to address issues of will continue to evaluate new measures to the RO Model secure data portal in comparability across practices and of patient experience for future the form, manner and at the time patient characteristics. consideration. consistent with the RO Model We will begin administering the After reviewing the comments requirements. survey in PY1 for baseline data received on our proposed quality As proposed, similar to the approach collection, to set appropriate measures, we are finalizing, with one taken for the QPP,70 the RO Model benchmarks, and to identify other modification in regard to the start date, would not score measures for a given methodological issues such as effects of our proposal to include a set of four Professional participant or Dual overlap with OAS CAHPS® on the quality measures for PY1. Instead of participant that does not have at least 20 response rate. We plan to propose via submitting quality measures data applicable cases according to each rulemaking a set of patient experience beginning in March, 2021, as proposed, measure’s specifications. However, domains based on the CAHPS® Cancer RO participants will submit data unlike the Quality Payment Program, if Care Survey, which would be included beginning in March, 2022, based on RO measures do not have at least 20 in the AQS as pay-for-performance episodes in PY1 (January 1, 2021, applicable cases for the participant, we measures beginning in PY3. Information through December 31, 2021), consistent would not require the measures to be on the established benchmarks will be with other changes to the timing of reported. In this situation, an RO made available on the RO Model Model implementation. We are also participant would enter ‘‘N/A- website. Regarding survey mode(s) and finalizing our proposal to have a CMS- insufficient cases’’ to note that an administration, CMS will be responsible approved contractor administer the insufficient number of cases exists for a ® for survey administration to CAHPS Cancer Care Survey for given measure. beneficiaries in the RO Model and will Radiation Therapy, with a modification As proposed, we would provide ensure survey methods are consistent that the survey will be administered Professional participants and Dual with the CAHPS® specifications, beginning in April 2021 rather than in participants with a mechanism to input including potential overlap with other 2020. quality measure data. We would create CAHPS® surveys. CMS will field the a template for Professional participants c. Form, Manner, and Timing for and Dual participants to complete with survey as specified to ensure reliability Quality Measure Data Reporting and validity of survey response data. the specified numerator and Further information about the survey We proposed to use the following data denominator for each quality measure development, testing, and fielding can collection processes for the four quality (and the number of cases excluded and be found on the survey website.69 We measures described in section exempt from the denominator, as per note that the version of the CAHPS® III.C.8.b(1) through (4) of this final rule measure specifications’ exclusions and beginning in PY1 (84 FR 34517). exemptions allowances), provide a 69 CAHPS® Cancer Care Survey. https:// First, we proposed requiring secure portal, the RO Model secure data www.ahrq.gov/cahps/surveys-guidance/cancer/ Professional participants and Dual index.html. participants to report aggregated quality 70 42 CFR 414.1380(b)(1)(iii).

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portal, for data submission, and provide Comment: Several commenters medical record for submission in either education and outreach on how to use recommended that CMS pay for RO electronic form, or via a template. these mechanisms for data collection participants to establish quality data Response: We will provide education and where to submit the data prior to reporting because of the potential for and outreach to help RO participants the first data submission period. high costs required to collect and report understand the quality measures and We proposed that Professional Model quality metrics. A couple of clinical data elements collection and participants and Dual participants commenters drew comparison to OCM, submission systems, including the would be required to submit quality which the commenters stated included template. As discussed in section measure data annually by March 31 additional payment for collecting III.C.8.b, based on stakeholder feedback, following the end of the previous PY to quality data. A commenter suggested we are finalizing the collection of the RO Model secure data portal (84 FR that CMS could assist with reporting quality measures data beginning in PY1 34518). In developing the March 31 cost by adding a patient management (January 1, 2021) with the first deadline, we considered the quality fee. submission due in March 2022, so RO measure reporting deadlines of other Response: We thank the commenters participants will have additional time to CMS programs in conjunction with the for their suggestions. We note that the become familiar with the template. As needs of the Model. For PY1, OCM does not include a payment to discussed in section III.C.8.e, based on participants will submit quality measure participants to collect quality data. To stakeholder feedback, we are finalizing data for the time period noted in the the extent that commenters may be the collection of clinical data elements measure specifications. We stated if a referring to the Monthly Enhanced beginning in PY1 (January 1, 2021) with measure is calculated on an annual CY Oncology Services (MEOS) payment, we the first submission due in July 2021. basis, participants would not be note that this payment is for the We also note that we plan to provide the required to adjust the reporting period provision of Enhanced Services, as final list of clinical data elements on the to reflect the model time period. We defined in the OCM Participation RO Model website prior to the start of stated that alignment to the measure Agreement, to OCM Beneficiaries. We PY1, and provide similar education and specifications used in MIPS would would also clarify that CMS will be outreach. We are committed to working likely reduce measure reporting burden paying for the administration of the with EHR vendors to facilitate data for RO participants. RO participants CAHPS® Cancer Care Survey and RO collection for quality measures and would submit measure data based on participants will not have additional clinical data element. Comment: A couple of commenters the individual measure specifications costs for the survey. We do not believe urged CMS to consider allowing set forth in sections III.C.8.b(1) through additional payments or an additional practices to use relevant third parties for (4), unless CMS were to specify different patient management fee are warranted at data collection and reporting, as it does individual measure specifications. RO this time. in other quality reporting programs. Model measure submissions would only Comment: A commenter supported Response: We intend to provide satisfy the RO Model requirements. CMS’ proposal to align the RO Model additional information about the Measures submitted to any other CMS with other quality reporting programs submission of data, prior to the PY1 program would need to continue to be and require at least 20 applicable cases data reporting start date on the RO made in accordance with that program’s according to each measure’s Model website. This information will requirements unless specifically noted. specification for scoring purposes. include whether we find it would be A schedule for data submission would Response: We thank the commenter appropriate to permit third-party data be posted on the RO Model website: for their support. submission. https://innovation.cms.gov/initiatives/ Comment: A few commenters Comment: Many commenters opposed radiation-oncology-model/. requested clarity on how participants the inclusion of all patients in the We proposed to determine that will report aggregated quality measure measure collection, asserting the Professional participants and Dual data and whether the RO Model secure Model’s quality measure requirements participants successfully collected and data portal will function similarly to the should only include Medicare patients. submitted quality measure data if the MIPS portal. Several of these commenters noted that data are accepted in the RO Model Response: RO participants will be including all patients is outside the secure data portal. Failure to submit required to report aggregated numerator scope of the Model. Others stated quality measure data within the and denominator data, not individual including non-Medicare patients will previously discussed requirements patient-level data, for all patients as create additional labor and require would impact the RO participant’s AQS, defined in the measure specifications. additional electronic health record as discussed in section III.C.8.f of the The process for submitting data through (EHR) updates and, if those updates are proposed rule (84 FR 34519) and this the RO Model secure data portal will be not successful, that RO participant will final rule. provided via technical support and have to provide manual collection and We proposed that the CAHPS® Cancer education efforts that take place reporting, which they argue is unduly Care Survey for Radiation Therapy following the final rule publication. We burdensome, especially on mid-size and would be administered by a CMS intend to announce the availability of smaller practices. A couple of contractor according to the guidelines these support and education commenters expressed concern that set forth in the survey administration opportunities on the RO Model website. reporting data on non-Medicare guide or otherwise specified by CMS. Comment: A commenter requested beneficiaries may result in a violation of Prior to the first administration of the more information on the quality privacy. survey, we would perform education measure and clinical data elements Response: We are requiring RO and outreach so RO participants will template, and noted that use of a participants to report aggregated have the opportunity to become more template will increase staff time, numerator and denominator data, not familiar with the CAHPS® Cancer Care practice overhead costs, and because individual patient-level data, for all Survey process and ask any questions. these data elements may not be discrete patients as defined in the measure The following is a summary of public fields within the EHR, someone may specifications in the manner consistent comments received and our response: have to transcribe information out of the with the quality measure specifications,

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and not just Medicare patients. It is reduced or not finalized because they burden associated with quality reporting important that the Model collect believe the requirements constitute by forcing providers and suppliers to measures in the manner specified to significant new administrative and utilize a third-party registry at costs over ensure submission consistency, and financial burdens on providers and and above previous investments in reliability of the data to comport with suppliers, especially on small providers EHRs. how the measure is currently specified and suppliers. A couple of commenters Response: We are using the registry and implemented in MIPS and other urged CMS to carefully consider the specifications for the measures in the quality initiatives. In addition, there is burden associated with quality and RO Model because they are the most inherent value to including all patients, clinical data collection requirements, widely used method of data submission, regardless of payer type, when assessing and ensure that only the most which will enable more participants to quality. We believe a policy of meaningful and least burdensome submit data with the least impact on submitting aggregated quality measure information is collected. Commenters workflow. Additionally, we believe the information in a manner consistent with noted that RO participants will be data from registry measures are both the measure specifications is not a spending a significant amount of time highly reliable and valid. Further, we violation of patient privacy because it and resources shifting their business agree that eCQMs and CEHRT are does not include the sharing of models to the new alternative payment valuable tools to help provide patient- personally identifiable information. model. centric care and we plan to provide Further, this is consistent with data Response: As part of the Meaningful structured data reporting standards so submission policy in MIPS. Finally, Measures Initiative, we are committed that existing EHRs can be adjusted if aggregated data can provide valuable to quality priorities that align CMS’ necessary in anticipation of the RO population-level perspective on the strategic goals and individual measures Model. Some EHRs may support data quality of care delivery. and initiatives that demonstrate that extraction, reducing any additional Comment: A few commenters quality for our beneficiaries is being reporting burden on RO participants, opposed the proposal to use a separate achieved. The quality measures chosen which may increase the quality and portal and a new website for data for the RO Model address concrete volume of reporting. We also believe collection and quality measure reporting quality topics, which reflect core issues that it is important that RO participants for measures already submitted to CMS, that are important to ensuring high have the option to extract the necessary stating this would create additional quality care and better patient outcomes data elements manually to ensure all RO operational burden for providers and during RT treatment. We acknowledge participants are able to submit the suppliers. Other commenters expressed the burden that reporting places on RO required data. concern about the burden, and the participants, and we seek to reduce Comment: A commenter opposed potentially significant programming unnecessary burden, to increase submitting registry-based measures, changes required, if RO Model measures efficiencies, and to improve the noting it would stymie CMS’ move were separated from MIPS, and if beneficiary experience in alignment toward interoperability and electronic hospitals were not developing similar with the Patients Over Paperwork end-to-end reporting. The commenter systems. Commenters encouraged CMS Initiative.71 We believe the quality argued that it would require new to simplify quality reporting by using measures selected for inclusion in the workflows that will need to be the current quality reporting RO Model balance both the importance developed in order to accurately mechanisms instead of creating yet of quality measurement and the attribute patients to the Model from another process for reporting quality concerns regarding burden as we strive multiple outpatient sites that are not data. A commenter requested to select the most parsimonious measure historically attached to our electronic clarification on whether quality measure set to ensure quality and support RO data base. reporting could come from clinical Model compliance with other Response: While we remain pathways and/or Clinical Decision concurrent programs, including MIPs committed to moving towards increased Support (CDS) systems. and QPP. Finally, for those practices interoperability and electronic Response: We appreciate the concern that have concerns about burden in reporting, we are using the registry regarding establishment of a new relation to their volume of radiotherapy specifications for measures in the RO infrastructure specific to this model. patients, we note that the Model Model because registry data is the most However, because the RO Model reaches includes a low volume opt-out option, widely used type of data submission across three different care settings, described in detail in section III.C.3.c. tool, which will enable more RO operational considerations necessitate Comment: A commenter was participants to submit data with least the creation of one portal that all supportive of the proposal to not require impact on workflow. We note that while entities can use. The process for that measures be submitted via CEHRT. the data collected via registries are submitting data through the RO Model Response: We appreciate the considered reliable and valid, we are secure data portal will be provided via commenter’s support. not requiring that RO participants technical support and education efforts Comment: A few commenters utilize a registry data system to satisfy that take place following the final rule recommended that all of the Model’s data submission to CMS. The Model publication, so all RO participants have quality measures be scoped as eCQMs will implement this measure based on time to become familiar with the so RO participants can use the certified the specifications used in MIPS, that is, infrastructure and processes prior to EHR in which they have already registry data. Additionally, we are not required reporting. In addition, we note invested, instead of utilizing a third- asking RO participants to attribute that the RO Model secure data portal party registry or reverting to claims- patients; participants will report will serve not only as a data submission based measurement. A commenter aggregate performance, consistent with system, but also as the portal for RO strongly rejected any non-eCQMs the measure specifications. participants to access claims data that because of its belief that registry-based Comment: A few commenters they can request through the Model. measures will significantly increase the supported the use of EHRs but Comment: Several commenters expressed concern with the feasibility of opposed the Model’s reporting 71 https://www.cms.gov/About-CMS/story-page/ EHR development in accordance with requirements and suggested they be patients-over-paperwork.html. the Model start date. These commenters

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asserted their belief that it is unlikely d. Maintenance of Technical We believe this information is that many, if any, EHR vendors will Specifications for Quality Measures necessary to achieve the Model’s goals have adequate time to make meaningful As part of its regular maintenance of eliminating unnecessary or low-value changes to the EHR to reduce the process for NQF-endorsed performance care. We have also heard from many reporting burden on RO participants. measures, NQF requires measure stakeholders that they believe Commenters further stated EHR vendors stewards to submit annual measure incorporating clinical data is important must assess their priorities and planned maintenance updates and undergo for developing accurate episode prices projects to accommodate the timing of Maintenance of Endorsement review and understanding the details of care CMS models, and noted this every three years. In the measure furnished during the episode that are not available in administrative data requirement would impact planning maintenance process, the measure sources. As proposed, we would use because participants must financially steward (owner/developer) is these data to support clinical plan for the likely significant charges to responsible for updating and monitoring and evaluation of the RO upgrade current systems, or to plan for maintaining the currency and relevance Model. These data may also be used to new systems, putting them at significant of the measure and will confirm existing inform future refinements to the Model. financial risk. These commenters or minor specification changes with We also proposed that we may also use therefore requested CMS delay NQF on an annual basis. NQF solicits it to begin developing and testing new implementation of this requirement information from measure stewards for radiation oncology-specific quality until vendors have enough time to annual reviews, and reviews measures implement and upgrade current measures during the Model. for continued endorsement in a specific To facilitate data collection, we systems. three-year cycle. We noted in the Response: We appreciate commenter’s proposed to share the clinical data proposed rule that NQF’s annual and/or elements and reporting standards with concerns regarding the feasibility of triennial maintenance processes for EHR development in accordance with EHR vendors and the radiation oncology endorsed measures may result in the specialty societies prior to the start of the Model start date. Continued EHR NQF requiring updates to the measures. development is an important part of our the Model. Our goal is to structure data Additionally, as described in the reporting standards so that existing ongoing effort to support electronic proposed rule, the Model includes health record data. The Model EHRs could be adjusted in anticipation measures that are not NQF-endorsed, of this Model. Such changes could allow performance period begins on January 1, but we anticipate they would similarly for seamless data extraction, reduce the 2021, which means the first submission require non-substantive technical additional reporting burden on of clinical data elements will not occur updates to remain current. providers and suppliers, and may until July of 2021 (this submission We received no comments on this increase the quality of reported data. timeframe is different than that for proposal and therefore are finalizing Providers and suppliers may also opt to submitting quality measures, which this policy as proposed. extract the necessary data elements occurs in March following a PY). This manually. All Professional participants will allow RO participants additional e. Clinical Data Collection and Dual participants with RO time to work with EHR vendors to We proposed to collect clinical beneficiaries treated for the five cancer develop appropriate fields. We will also information on certain RO beneficiaries types, as previously listed, would be provide which clinical data elements included in the Model from Professional required to report clinical data through are included in the RO Model on the RO participants and Dual participants that the RO Model secure data portal. We Model website and will provide those furnish the PC of an episode for use in would create a template for RO reporting standards to EHR vendors and the RO Model’s pay-for-reporting participants to complete with the the radiation oncology specialty approach and for monitoring and specified clinical data elements, provide societies prior to their inclusion in the compliance, which we discussed more a secure RO Model secure data portal for Model. Our goal is to structure data fully in sections III.C.8.f(1) and III.C.14 data submission, and provide education reporting standards so that existing of the proposed rule (84 FR 34519; 84 and outreach on how to use these EHRs could be adjusted, if necessary, in FR 34531) and this final rule. As mechanisms for data collection and anticipation of the measure and clinical proposed (84 FR 34518), on a pay-for- where to submit the data prior to the date element requirements. reporting basis, we would require first data submission period. Additionally, we note that RO Professional participants and Dual We also proposed to establish participants will continue to have the participants to report basic clinical reporting standards. All Professional option to extract the necessary data information not available in claims or and Dual participants would be required elements manually. captured in the quality measures, such to submit clinical data twice a year, in After consideration of the as cancer stage, disease involvement, July and January,72 each PY for RO commenters’ feedback, we are finalizing treatment intent, and specific treatment beneficiaries with the applicable cancer our proposals for the data collection plan information, on RO beneficiaries types that completed their 90-day RO processes for the four quality measures treated for five types of cancer under the episode within the previous 6 months. described in section III.C.8.b(1) through Model: (1) Prostate; (2) breast; (3) lung; This would be in addition to the (4) of this final rule beginning in PY1 (4) bone metastases; and (5) brain submission of quality measure data as with the first annual submission in metastases, which we proposed to described in section III.C.8.c of the March 2022 and continuing thereafter. require as part of § 512.275. We would proposed rule (84 FR 34519). The process for submitting data through determine the specific data elements We solicited specific comment and the RO Model secure data portal will be and reporting standards prior to PY1 of feedback on the five cancer types for provided via technical support and the Model and would communicate education efforts that take place them on the Model website. In addition, 72 We are clarifying that the first submission for following the final rule publication. We as we described in the proposed rule, PY1 would be made in July of PY1 and the second we proposed to provide education, submission for clinical data for PY1 would be made intend to announce the availability of in January of PY2. The submission schedule for the these support and education outreach, and technical assistance in following PYs would be similar and the final opportunities on the RO Model website. advance of this reporting requirement. submission for PY5 would occur in January 2026.

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which we proposed to collect clinical Response: We thank commenters for practicable while continuing to collect data, which data elements should be their suggestions. We will review each meaningful and parsimonious data sets. captured for the five cancer types, and suggestion carefully as we consider Comment: A few commenters potential barriers to collecting data of which clinical data elements to include expressed concern about requiring the this type. The following is a summary as part of the RO Model. reporting of clinical data elements for of the public comments received and Comment: A few commenters patients not participating in Medicare. our response. opposed all clinical data reporting One was concerned that such reporting Comment: A couple of commenters requirements. Some commenters could impose significant administrative supported the collection of clinical data opposed the clinical data elements burdens on RO participants in order to elements because it would require because of the perceived financial ensure compliance with the Health Professional participants and Dual burden, noting that without structured Insurance Portability and participants to report basic clinical EHR fields to report, participants have Accountability Act (HIPAA). information not available in claims or increased burden to report the measures Response: We would like to clarify captured in the proposed quality manually or through a registry, without that while quality measures used in the measures, which the commenters significant benefit to patients. One of RO Model will include non-Medicare believe will encourage better care. these commenters also expressed beneficiary data collected in the Another commenter supported tracking concern with the lack of information aggregate, we intend only to require data on clinical care because it improves about how CMS would use this data. clinical elements data reporting for patients care. Another commenter argued that CMS Medicare beneficiaries in the Model (RO should only require clinical data beneficiaries). Response: We thank commenters for Comment: Several commenters submissions once it commits to supporting our proposal to collect recommended delaying or phasing-in incorporating those data into payment information on clinical data elements. the implementation of the clinical data rates’ risk adjustments. Comment: A few commenters requirement until the data can be responded to our request for comments Other commenters urged CMS to submitted by all RO participants in a on clinical data elements reporting. A carefully weigh the necessary and useful and meaningful way. A few commenter recommended that CMS appropriate uses for the data against the commenters urged CMS to delay the only request clinical data elements that significant time, effort, and quality reporting requirements for the guide treatment decisions. Another administrative burden required in order Model for at least six months, while commenter recommended including to report those data. Another commenter another requested 18 months, asserting only the most clinically relevant opposed clinical data elements the lack of granularity in the proposed information. Some commenters reporting because it believes the rule will prevent vendors from updating provided suggestions for the following reporting would be uncompensated and reporting specifications. A couple of clinical data elements: Clinical reduce productivity. Another commenters recommended delaying treatment plan; therapeutic status; commenter strongly opposed the clinical data element collection until elements that would align with the collection of clinical data elements PY2. Surveillance, Epidemiology, and End because the commenter believes much Response: We thank the commenters Results (SEER) cancer database; the of the clinical data element information for their suggestions on either delaying results of Prostate-Specific Antigen that CMS is considering is already or phasing in the implementation of the (PSA) tests; information related to the available in Surveillance, Epidemiology, clinical data elements requirement. As American Joint Committee on Cancer and End Results (SEER) Incidence Data. discussed in section III.C.1 we are (AJCC) staging system and the histology Response: We believe that collecting finalizing the Model performance period of the malignancy for lung, breast and clinical data elements for use in the RO to begin January 1, 2021, and publishing prostate; ‘‘D’Amico’’ or the National Model is necessary to achieve the the final rule several months in advance Comprehensive Cancer Network (NCCN) Model’s goals of supporting evidence- of this start date, in order to provide RO risk grouping; site of the lesion based care. We appreciate the participants with sufficient time to information; existence, and number, of recommendation that the Model align prepare for their inclusion in the Model. metastases; patient performance status with the SEER Incidence Database, During this time, we plan to provide the submitted (Karnofsky Performance however we believe that the geographic clinical data elements on the RO Model Status or Eastern Cooperative Oncology areas captured by SEER do not align website and provide education and Group (ECOG) status); and information with the RO Model CBSAs. We have outreach support to encourage the relating to whether medical physicists heard from many stakeholders that they efficient collection and submission of have reviewed the chart. Other believe incorporating clinical data is this data. We believe finalizing the commenters recommended collecting important for developing accurate Model performance period to begin on data on RO participants’ use of episode prices and understanding the January 1, 2021, will allow RO standardized clinical pathways and/or details of care furnished during an RO participants time to develop best CDS and whether the treatment is episode that are not available in practices to facilitate their data curative, palliative, or benign. A administrative data sources, specifically collection, and work with EHR vendors commenter recommended including the claims. We will use these data to to seek additional EHR support as reporting of site of treatment, dose support clinical monitoring and needed. specification (for example, ‘‘95 percent evaluation of the RO Model. These data Comment: Several commenters urged of specified dose to 95 percent of the may also be used to inform future CMS to consider the HL7® FHIR®-based planning treatment volume’’) and refinements to the Model. We may also mCODETM (Minimal Common Oncology number of fractions as clinical data use it to begin developing and testing Data Elements) to collect and assemble elements. Other commenters suggested new radiation oncology-specific quality a core set of structured data elements for that clinical and staging data elements measures during the Model. In keeping oncology EHRs. Commenters should be collected for complete RO with our goal of reducing burden, we recommended mCODETM based on their episodes and original primary cancer intend to align with other federal belief that the use of mCODETM would type for brain and bone metastases. programs to the greatest extent structure data reporting standards so

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that existing EHRs could be adjusted in applicability of the ONC 21st Century elements to include because we believe anticipation of this Model, which would Cures Act: Interoperability, Information that the highest priority with respect to allow better data extraction and reduce Blocking, and the ONC Health IT any clinical data elements collected is the additional reporting burden on Certification Program proposed rule and that they inform our understanding of providers and suppliers, and may expressed concern that while vendors RT services, and this priority should not increase the quality of reporting and have to comply with federal regulations, be limited to clinical data elements that their belief that clinical data elements they could pass these costs to are already collected. CMS will notify considered by mCODETM would address physicians.73 participants via the RO Model website CMS’ goal of collecting meaningful Response: We believe advancing prior to the start of PY1 about which clinical data elements information. interoperability is an important step in clinical data elements will be included Another commenter recommended healthcare quality improvement and in the Model. RO participants will be HL7® more generally because of its that putting patients at the center of required to report clinical data through belief that it would reduce duplicative their health care and ensuring they have the RO Model secure data portal. entries and reduce errors. access to their health information is Comment: A couple of commenters Response: Participants will be highly desirable. We are committed to recommended that CMS establish required to report clinical data through working with the ONC to address reporting standards and timelines that the RO Model secure data portal at the interoperability issues and achieve provide enough time for EHR vendors to time and in a manner specified by CMS. complete access to health information implement corresponding report ® While we are aware of HL7 mCODETM, for patients in the health care system. updates that enable discrete capture, we are not confident that it will be We will continue to work with ONC and and for RO participants to collect immediately accessible to the full other federal partners toward complete and accurate clinical data. breadth of RO participants due to interoperability and the secure and Response: We plan to share the ® technical requirements of HL7 and it timely exchange of health information proposed clinical data elements and may not be feasible to test and with the clear objectives to improve procedural instructions for reporting implement by the beginning of the patient access and care, alleviate health information at a time and manner Model performance period; therefore, care provider burden, and reduce specified by CMS with EHR vendors we believe that our RO Model secure overall health care costs while and the radiation oncology specialty data portal will provide the easiest, considering provider and supplier costs. societies prior to the start of PY1. Our most accessible access for most RO We will also assess opportunities to goal is to structure data reporting so that participants. We continue to monitor coordinate on a minimum set of existing EHRs could be adjusted in developments in EHR and oncology data elements. Finally, we anticipation of the RO Model. Such interoperability. We also continue to appreciate and understand the concern changes could allow for seamless data engage with health care providers and that EHR vendors may pass some of the extraction and reduce the additional EHR vendors to align the information costs of regulatory compliance on to the reporting burden on RO participants, about the most meaningful clinical data physicians; however, we believe that is and may increase the quality of elements to include in the RO Model, it possible that most of the information reporting. Comment: A commenter appreciated and ensure that the greatest number of requested will already be included as the decision that CMS share the planned RO participants can implement the data part of the EHR and will provide elements, and procedures for reporting collection process with the least amount valuable information to RT providers of burden. them, with EHR vendors and radiation and RT suppliers. oncology specialty societies, and Comment: A commenter strongly Comment: A few commenters requested that CMS also share this urged CMS to encourage recommended that CMS should narrow implementation of bidirectional data information with oncology clinical the focus and use of clinical data flow between the applicable clinical pathways developers. This commenter required for reporting and ensure that pathways and/or CDS systems, and the encouraged CMS to consider taking all required data elements are EHR, which it believes would reduce clinical pathway extracts of these data consistently documented in structured duplicative data entry and time- to satisfy requisite reporting. and discrete fields, and further asserted intensive information searches by the Response: We thank the commenter CMS should not require the submission physician when a data element is for the suggestion that CMS consider of any data elements that are not already present in the EHR. allowing the submission of clinical Response: We thank the commenter captured in structured fields by most pathway extracts of data elements to for their suggestion and support the major EHR vendors. These commenters satisfy this aspect of the reporting improvement of reporting pathways. We urged CMS to work with EHR vendors requirements. In the process of encourage RO participants to explore prior to the Model start date to establish determining the clinical data elements, efficiencies within their EHR systems structured fields for all mandatory CMS will conduct outreach with and other data platforms; however, we reporting requirements. multiple stakeholders, including do not wish to prescribe EHR Response: As we review which oncology clinical pathways developers. requirements to participants and clinical data elements are appropriate However, we do not believe that only vendors. for inclusion in the RO Model, we will using the clinical pathways is a feasible Comment: A couple of commenters consider which clinical data elements way to collect clinical data elements encouraged CMS to partner with the are already documented and available in information across all RO participants at Office of the National Coordinator for the structured and discrete fields of the this time. In the future, we will consider Health Information Technology (ONC) EHR; however, availability in the EHR ways to integrate clinical pathways into to require that certified EHRs store and will not be the sole consideration in the clinical data element collection transmit a minimum set of oncology determining which clinical data process. data elements, which would allow their After considering public comments, 73 https://www.federalregister.gov/documents/ use under current and future Innovation 2019/04/23/2019-08178/21st-century-cures-act- we are finalizing at § 512.275(c) the Center models. Another commenter interoperability-information-blocking-and-the-onc- proposal to collect basic clinical requested clarification regarding the health-it-certification. information not available in claims or

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captured in the quality measures, reporting such as at the time and specific treatment plan information on describing cancer stage, disease manner specified by CMS. We have beneficiaries treated for specific cancer characteristics, treatment intent, and modified the text of the regulation at types) is an exhaustive list. specific treatment plan information, on § 512.275(c) to clarify that paragraph (c) Table 11 includes the four RO Model RO beneficiaries treated for five types of applies to the reporting of quality quality measures and CAHPS® Cancer cancer under the Model: (1) Prostate; (2) measures and clinical data elements and Care Survey, the level at which breast; (3) lung; (4) bone metastases; and that such reporting is in addition to the (5) brain metastases. We will determine measures will be reported, and the reporting described in other sections of measures’ status as pay-for-reporting or the specific data elements prior to PY1 this rule. We have also modified the of the Model and will communicate pay-for-performance, as described in regulatory text at § 512.275(c) such that them on the RO Model website, with section III.C.8.b of this final rule. The the list of clinical data element data collection starting in PY1. table also includes the RO Model We are also clarifying that clinical categories we proposed in the proposed clinical data elements collection, and data will be submitted to CMS rule (that is, cancer stage, disease years, also documented in section consistent with the instructions for characteristics, treatment intent, and III.C.8.e of this final rule.

f. Connect Performance on Quality applicable RO beneficiaries in section Professional participant or Dual Measures to Payment III.C.8.e of the proposed rule (84 FR participant. (1) Calculation for the Aggregate Quality 34518) and this final rule. Given the importance of clinical data A measure’s quality performance Score for monitoring and evaluation of the RO benchmark is the performance rate a Model, and the potential to use the data We proposed that the AQS would be Professional participant or Dual for model refinements or quality based on each Professional participants participant must achieve to earn quality measure development, we proposed to and Dual participant’s: (1) Performance points for each measure in section weight 50 percent of the AQS on the on the set of evidenced-based quality III.C.8.b.74 We believe a Professional successful reporting of required clinical measures in section III.C.8.b of the participant’s or Dual participant’s data and the other 50 percent of the proposed rule (84 FR 34515 through performance on these quality measures, AQS on quality measure reporting and, 34517) and this final rule compared to as well as successful reporting of pay- where applicable, performance on those those measures’ quality performance for-reporting measures and clinical data measures. Mathematically, this benchmarks; (2) reporting of data for the elements, would appropriately assess weighting would be expressed as pay-for-reporting measures (those the quality of care provided by the follows: without established performance benchmarks) in section III.C.8.b(4) of the 74 Benchmarks will be based on existing MIPS Aggregate Quality Score = Quality proposed rule (84 FR 34515 through benchmarks, or other national benchmark where measures (0 to 50 points based on available. For measures without existing 34517) and this final rule; and (3) benchmarks, we plan to develop our own weighted measure scores and reporting of clinical data elements on benchmarks. reporting) + Clinical data (50 points

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when data is submitted for ≥95% of time, and manner specified would reporting requirements and will receive applicable RO beneficiaries) receive zero points. As discussed in zero out of ten for that measure in the We proposed that quality measures section III.C.8.b(4) of the proposed rule quality portion of the AQS, as the would be scored as pay-for-performance (84 FR 34517) and this final rule, the example in Table 13 represents. If the or pay-for-reporting, depending on Treatment Summary Communication same Professional participant or Dual whether established benchmarks exist, measure will be the only pay-for- participant scored the same 20 points on as stated in section III.C.8 of this rule. reporting measure in PY1. three measures, but failed to report the To score measures as pay-for- The total points awarded for each necessary data on a fourth measure, its performance, each Professional measure included in the AQS would AQS denominator would be set at 40 participant’s and Dual participant’s also depend on the measure’s weight. possible points. Its AQS would then be performance rates on each measure We would weight all four quality equivalent to 25 points after would be compared against applicable measures (those deemed pay-for- recalibrating the denominator to 50 MIPS program benchmarks, where such performance as well as pay-for- points ((20/40) * 50 = 25). benchmarks are available for the reporting) equally and aggregate them as In the proposed rule, we stated that measures. We proposed to select the half of the AQS. To accomplish that our assessment of whether the measures as pay-for-performance for aggregation as half of the AQS, we Professional or Dual participant has PY1 from the list of MIPS quality would award up to ten points for each successfully reported clinical data measures: (1) Advance Care Plan; (2) measure, then recalibrate Professional would be based on whether the Preventive Care and Screening: participants’ or Dual participants’ participant has submitted the data in the Screening for Depression and Follow- measure scores to a denominator of 50 time period identified and has furnished ® Up Plan; (3) Oncology: Medical and points. CAHPS Cancer Care Survey for the clinical data elements to us as Radiation—Plan of Care for Pain. The Radiation Therapy results discussed in requested, as discussed in section MIPS Program awards up to ten points section III.C.8.b(5) of this final rule III.C.8.c of the proposed rule (84 FR (including partial points) to participants would be added into the AQS beginning 34517 through 34518) and this final for their performance rates on each in PY3, and we would propose the rule. We stated that Professional measure, and we would score RO specific weights of the selected participants and Dual participants ® participants’ quality measure measures from the CAHPS survey in would either be considered ‘‘successful’’ performance similarly using MIPS future rulemaking. We would also reporters and receive full credit for benchmarks.75 For example, when a specify weights for new measures if and meeting our requirements, or ‘‘not Professional or Dual participant’s when the Model adopts additional successful’’ reporters and not receive measured performance reaches the measures in the future. credit. We stated that we would define performance level specified for three In cases where Professional successful reporting as the submission points, we will award the participant participants and Dual participants do of clinical data for 95 percent of RO three points. If applicable MIPS not have sufficient cases for a given beneficiaries with any of the five benchmarks are not available, we would measure—for example, if a measure diagnoses listed in section III.C.8.e of use other appropriate national requires 20 cases during the applicable the proposed rule (84 FR 34518 through benchmarks for the measure where period for its calculation to be 34519) and this final rule. We also appropriate. If a national benchmark is sufficiently reliable for performance stated that if the Professional participant not available, we would calculate scoring purposes—that measure would or Dual participant does not Model-specific benchmarks from the be excluded from the participant’s AQS successfully report sufficient clinical previous year’s historical performance denominator calculation and the data to meet the 95 percent threshold, data. If historical performance data are denominator would be recalibrated it would receive 0 out of 50 points for not available, then we would score the accordingly to reach a denominator of the clinical data elements component of measure as pay-for-reporting and will 50 points. This recalibration is intended the AQS. As previously discussed, we provide credit to the Professional to ensure that Professional participants are finalizing our proposed clinical data participant or Dual participant for and Dual participants do not receive any elements reporting requirements, and reporting the required data for the benefit or penalty for having insufficient we plan to post these requirements via measure. We would specify quality cases for a given measure. the RO Model website prior to PY1. measure data reporting requirements on For example, a Professional or Dual To calculate the AQS, we proposed to the RO Model website. Once participant might have sufficient cases sum each Professional or Dual benchmarks are established for the pay- to report numerical data on just three of participant’s points awarded for clinical for-reporting measures, we would seek five RO Model measures, meaning that data reporting with its aggregated points it has a total of 30 possible points for the to use the benchmarks to score the awarded for quality measures to reach a quality measures component of its AQS. measures as pay-for-performance in value that would range between 0 and If the Professional participant or Dual subsequent years. 100 points. As discussed earlier in this As stated earlier in this rule, measures participant received scores on those rule, we would recalibrate the points we may also be scored as pay-for-reporting. measures of nine points, four points, award for measures to a denominator of Professional participants and Dual and seven points, it will have scored 20 50 points. We would then divide the participants that report a pay-for- out of 30 possible points on the quality AQS by 100 points to express it as a reporting measure in the form, time, and measures component. That score is percentage. manner specified in the measure equivalent to 33.33 points after To illustrate the calculation of the specification would receive ten points recalibrating the denominator to 50 AQS score, two examples are included for the measure. Professional points ((20/30) * 50 = 33.33). In in this final rule. Table 12 details the participants and Dual participants that instances where a Professional AQS calculation for a Professional do not submit the measure in the form, participant or Dual participant fails to participant or Dual participant that did report quality reporting data for a not meet the minimum case 75 The benchmarks are published annually at this measure in the time, form and manner requirements for one of the pay-for- CMS site: https://qpp.cms.gov/about/resource- required by the RO Model as described performance measures. library. in section III.C.8.c will not meet the BILLING CODE 4120–01–P

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Table 13 details the AQS calculation that did not meet the reporting elements or the pay-for-reporting for a Professional or Dual participant requirements for the clinical data measure.

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BILLING CODE 4120–01–C recommended that we adopt a partial complete as practicable and provide an We believe that this method has the points policy for clinical data elements accurate reflection of the clinical profile benefits of simplicity, normalization of reporting so that participants are not of the RO participant’s patient differences in reported measures confronted with a pass/fail requirement population. We believe that staggering between RO participants, and in the AQS. the requirements will increase the appropriate incorporation of clinical Response: We thank commenters for operational complexity of the Model data reporting. this feedback. We remain concerned and make it harder for participants to We solicited public comment on the that adopting a lower threshold than the comply with the requirements, whereas calculation for the AQS methodology. proposed 95 percent for successful maintaining the 95 percent requirement The following is a summary of the clinical data elements reporting would as a consistent and simple standard of public comments received on this result in RO participants reporting data reporting submitted twice a year in July proposal and our response: that is less useful for future quality and in January ensures that RO Comment: Several commenters measure development. participants understand what is opposed the 95 percent threshold for Comment: A commenter urged CMS expected of them well ahead of time. successful clinical data element to adopt a three- to six-month reporting Comment: A commenter encouraged reporting based on their belief this window for clinical data elements, CMS to maintain the link between threshold would not allow for the which would allow RO participants to various scenarios where obtaining abstract and validate data for reporting quality measures and prospective clinical data, especially from the time of to CMS following completion of an RO payments, which would allow the initial diagnosis, is not feasible, would episode. The commenter suggested that Model to qualify as an Advanced APM require significant time and resources to the time period for submission should because then the Advanced APM bonus obtain, or be overly burdensome. A be contingent on volume and practice would be available to participating couple of commenters recommended resources and suggested that RO radiation oncologists if they are that CMS begin with a 70 percent participants should be given 90 days for designated as Qualified APM reporting requirement and reassess 75 percent of submissions, and 180 days Participants. whether that level can be increased in for 85 percent submissions. Response: We thank the commenter future years. A few commenters Response: We believe 95 percent is and agree regarding the benefits recommended a score of 75 percent the appropriate threshold for clinical associated with maintaining the link rather than 95 percent. A commenter data element reporting because of the between quality measures and recommended a score of 80 percent to value in obtaining this information, prospective payments. Our intent is to receive full credit for reporting clinical which we believe will allow us to ensure that the Model will qualify as an data elements in the AQS. A commenter ensure that the data collected are as Advanced APM starting in PY1.

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Comment: A commenter argued that agree with the commenter that adopting episodes until March 2022, which also the Model’s relative scoring MIPS benchmarks where available will provides time for familiarization. During methodology, where RO participants are align the Model and MIPS. We would PY1 and before the first submission in assessed against each other rather than also like to clarify that we proposed to March 2022, we will provide education, against absolute benchmarks, means adopt the registry specifications for the outreach, and feedback reports to help that RO participants can be penalized Model’s measures—see, for example, 84 participants understand the quality and significantly on measures even when FR 34516 (‘‘For the RO Model, we clinical data elements collection and they perform at high levels, as measured propose to use the registry submission systems. Between the by percentages. The commenter noted specifications for [the Plan of Care for availability of national benchmarks for that this result means little Pain] measure’’) which include data the three pay-for-performance measures differentiation among health care collection procedures. and the time period in which RO providers’ performance but significant Comment: Some commenters noted participants will have access to differences in payments and suggested that some of the 2019 MIPS benchmarks information about these measures, we that CMS instead consider adopting an are topped-out for some of the Model’s believe it is appropriate to retain these absolute scoring method. The measures and expressed concern that measures as pay-for-performance commenter also argued that scoring RO RO participants will therefore not beginning in PY1 as originally participants against each other receive the full 10 points for submitting proposed. Starting in PY2 (once quality discourages sharing lessons learned or data on those measures. A commenter measure data for PY1 has been best practices, which the commenter argued that CMS should provide as submitted) and continuing thereafter, believed is not an optimal quality much flexibility as possible to RO we intend to provide detailed and improvement strategy. participants earning points so that they actionable information to RO Response: We understand the can earn back their quality withholds. participants related to their performance commenter’s concerns but disagree with Another commenter recommended that in the Model, as described in section the commenter’s assessment of a relative scoring should be stratified by III.C.14.c. of the proposed rule (84 FR scoring method rather than absolute performance-level quintiles. 34532). We intend to determine the performance scoring. The principal Response: We thank the commenters design of and frequency of those reports advantage of a relative performance for this feedback. As we noted in section in conjunction with the RO Model scoring system is that it bases III.C.8.b, there can be value to retaining implementation and monitoring performance goals on real-world topped-out measures. We further note contractor. performance rather than on goals that that in the absence of other clinically Comment: A commenter stated its could otherwise be perceived as appropriate measures, retaining topped- appreciation for our proposals to align arbitrary. While MIPS benchmarks are out measures may give us the best our quality programs and for adopted in advance, they are based on possible assessment of clinical care establishing a clear distinction between historical performance data and thus quality available. We believe we have pay-for-performance and pay-for- allow us to assess practices based on adopted an effective and parsimonious reporting requirements. real-world performance. We expect RO measure set aimed precisely at the Response: We thank the commenter participants to strive to deliver high commenter’s goal of providing as much for supporting our plan to align quality quality evidence-based care for all flexibility as possible to RO participants programs and distinguish our reporting patients consistent with established and to earn points. We are finalizing the list requirements. emerging best practices. However, we of measures and scoring methodology as After consideration of the public will consider the commenter’s concern proposed and encourage stakeholders to comments that we have received, we are as we adopt benchmarks in future years continue new measure development finalizing the AQS calculation as for the Treatment Summary efforts. proposed and finalizing the definition of Communication and CAHPS® Cancer Comment: Some commenters the AQS at § 512.205. Care survey measures. recommended that CMS calculate the (2) Applying the AQS to the Quality Comment: A few commenters noted AQS using pay-for-reporting on the four Withhold that the proposed rule did not specify quality measures for at least the Model’s We proposed to use the following which benchmarks or data collection first year—with a commenter extending method to apply the AQS to the amount types CMS would use for RO Model that recommendation to the second of the quality withhold that could be measures. A commenter recommended year—before transitioning to a pay-for- earned back by an RO participant (84 FR CMS adopt MIPS benchmarks and data performance program. A commenter 34522). We would multiply the collections to ensure an easy transition asserted this delay would permit Professional participant’s or Dual and maintain alignment between quality participants to become familiar with the participant’s AQS (as a percentage) reporting programs. A commenter Model’s quality measures and against the 2 percent quality withhold suggested that an RO participant’s implement workflow changes. Another amount. For example, if a Professional performance could be based on regional commenter argued that such a delay participant or Dual participant received or national comparisons, while another would enable the agency to clarify its an AQS of 88.3 out of a possible 100, recommended using performance-level benchmarks for quality reporting and then the Professional participant or Dual quintiles. A commenter recommended provide participants enough time to participant would receive a 1.77 percent using the MIPS benchmarks to align the become familiar with them. The quality reconciliation payment amount Model’s quality reporting with other commenter also recommended that we (0.883 * 2.0 = 1.77%). If the total CMS programs. provide confidential feedback reports episode payment amount for this RO Response: We would like to clarify with performance information that can participant after applying the trend that, as stated in the proposed rule be reviewed and corrected, as done in factor, adjustments, and discount factor (footnote 57 at 84 FR 34519), we would other CMS quality programs. was $2,465.68,76 the example AQS of base benchmarks on MIPS benchmarks Response: We thank the commenters 88.3 would result in a quality where available, and that we would for this feedback. We note that RO develop benchmarks for those measures participants will not be required to 76 This number refers to the result in line (j) in that do not have MIPS benchmarks. We submit quality measure data on PY1 RO Table 5 from the proposed rule.

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reconciliation payment amount of participants and the amount of the we should therefore adopt a scoring $43.64 ($2,465.68 * 1.77% = $43.64).77 reduction will depend on a number of ‘‘curve’’ or other form of adjustment that We proposed to continue to weight factors, including episode price as would offer full credit for performance measures equally in PY1 through PY5 determined by the pricing methodology at levels below the measure’s unless we determined that the Model discussed in section III.C.6, and their benchmark. needs to emphasize specific clinical performance on the AQS. We note that After consideration of the public transformation priorities or added new in any case, one of the benefits of the comments that we have received, we are measures. Any updates to the scoring RO Model is bundling payments for all finalizing our proposed policy to apply methodology in future PYs will be included RT services rather than the AQS to the Quality Withhold to proposed and finalized through notice remitting them piecemeal over the begin in PY1 as finalized in section and comment rulemaking. There may be course of the RO episode. Finally, we III.6.g(2). some variation in the measures that we note that section III.C.7 of this final rule 9. The RO Model as an Advanced score to calculate the AQS for states that RO participants will be able Alternative Payment Model (Advanced Professional participants and Dual to receive EOE payments as early as day APM) and a Merit-Based Incentive participants should they be unable to 28 of the RO episode, a change from the Payment System APM (MIPS APM) report numerical data for certain proposal to reimburse the final half of measures due to sample size constraints the episode payment after the 90-day As we stated in the proposed rule, we or other reasons. However, as discussed episode period is over. anticipate that the RO Model will be in the proposed rule, we do not Comment: A commenter suggested both an Advanced APM and a MIPS anticipate that variation will create any that CMS consider rewarding top- APM. For purposes of the Quality methodological problems for the performing providers and suppliers Payment Program, the RO participant, Model’s scoring purposes. with additional reimbursements rather specifically either a Dual participant or The AQS would be calculated than subjecting them to a quality a Professional participant, would be the approximately eight months after the withhold. The commenter argued that APM Entity. end of each PY and applied to calculate this type of incentive structure would be We proposed that we would establish the quality withhold payment amount consistent with the Quality Payment an ‘‘individual practitioner list’’ under for the relevant PY. Any portion of the Program and would move Medicare the RO Model (84 FR 34522). We quality withhold that is earned back policy away from focusing on penalties, proposed that this list would be created would be distributed in an annual lump as the commenter suggested has been by CMS and sent to Dual participants sum during the reconciliation process as prevalent in hospital quality programs. and Professional participants to review, described in section III.C.11 of this final Response: With respect to the AQS, revise, certify, and return to CMS so that rule. RO participants will not be able to earn CMS would be able to make QP We solicited public comments on our back more than the quality withhold. determinations and calculate any proposal to apply the AQS to the However, we believe that top performers applicable APM Incentive Payments, amount of the quality withhold in in the Model will have the opportunity, and to identify any MIPS eligible section III.C.6.g(2) of the proposed rule via the Model’s payment methodology, clinicians who would be scored for (84 FR 34509). and the Advanced APM and MIPs MIPS based on their participation in The following is a summary of the incentives, to earn total payments in this MIPS APM. The individual public comments received on this excess of their historical payments. For practitioner list would serve as the proposal and our response: this reason, we believe that the Model’s Participation List (as defined in the Comment: A commenter expressed design serves to incentivize all RO Quality Payment Program regulations at concern about the AQS’s structure and participants to strive for high quality 42 CFR 414.1305) for the RO Model. We its interactions with incentives, noting and earn the available incentive proposed to codify the term ‘‘individual that every participant would receive the payments. practitioner list’’ for purposes of the RO quality withhold, but top performers Comment: A commenter expressed Model in § 512.205 of our proposed would receive incentive payments over support for the Model’s proposed regulations. a year later. The commenter also measures but argued that it is unrealistic We proposed, at 84 FR 34522, that the asserted that most practices would to expect RO participants to score 100 individuals included on the individual receive a net payment cut because they percent for all measures. The practitioner list would include would not earn the full withhold back. commenter suggested that we adopt an physician radiation oncologists who are Response: We thank the commenter 80 percent performance threshold for eligible clinicians participating in the for these concerns. However, we view full credit within the quality portion of RO Model with either a Dual participant the trade-offs associated with the the AQS. or a Professional participant as Model’s incentive payment timing as Response: We thank the commenter described in section III.C.3.b of this final necessary within the framework of an for this suggestion, but we do not rule. Eligible clinicians who are episode-payment model that will, by believe that establishing firm thresholds identified on the Participation List for design, accelerate much of the episode- within the AQS calculation would serve an Advanced APM during a QP based payments to RO participants. We our quality improvement goals. We Performance Period may be determined will endeavor to calculate individual continue to believe that the Model’s to be Qualifying APM Participants (QPs) quality measure scores and an annual scoring structure must encourage as specified in our regulations at 42 CFR AQS, produce reports, and determine consistent improvement in the Model’s 414.1425, 414.1435, and 414.1440. payment adjustments as swiftly as quality metrics, and we are concerned Similarly, under the current Quality possible. While we agree with the that establishing a scoring threshold as Payment Program rules, MIPS eligible commenter’s sentiment that some RO suggested by the commenter would offer clinicians identified on the Participation participants will see a payment disincentives for continued List for the performance period of an reduction, we note that the number of improvement. While we agree with the APM Entity participating in a MIPS commenter that we do not expect RO APM would be scored for MIPS using 77 This number is prior to the geographic participants to score 100 percent on all the APM scoring standard as provided adjustment and sequestration being applied. quality measures, we do not agree that in our regulation at 42 CFR 414.1370.

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We proposed that only Professional notice must be submitted in a form and throughout such model year in a participant physicians and Dual manner specified by CMS. manner sufficient to meet the participant physicians included on the We proposed that in order to remove requirements pursuant to 42 CFR individual practitioner list would be an individual practitioner from the list, 414.1415(a). Annual certification would considered eligible clinicians the RO participant must notify CMS be required prior to the start of each participating in the RO Model, for within 15 days after an individual subsequent PY. purposes of the Quality Payment practitioner ceases to be a Medicare- We solicited public comments on our Program. enrolled supplier that bills for RT proposal. The following is a summary of We proposed that we would create services under a billing number the public comments received on this and provide each Dual participant and assigned to the TIN of the RO proposal and our responses: Professional participant with an participant; the timely removal would Comment: A commenter commended individual practitioner list prior to the be effective on the date specified in the CMS’ dedication to implementing more start of each PY (84 FR 34522). We notice furnished to CMS, but not earlier Advanced APMs that would allow proposed that the Dual participants and than 15 days before the date of the specialists the opportunity to become a Professional participants must review notice (84 FR 34522). If the RO QP. Specifically, the commenter and certify the individual participant participant fails to submit timely notice suggested that there is insufficient list within 30 days of receipt of such list of the removal, the removal would be opportunity for specialists to qualify for in a form and manner specified by CMS. effective on the date of the notice. The QP status under the Quality Payment In the case of a Dual participant or notice must be submitted in a form and Program, and therefore the commenter Professional participant that begins the manner specified by CMS. Further, we applauds CMS’ dedication to improving RO Model after the start of PY, but at proposed that the RO participant must this. Response: We appreciate this least 30 days prior to the final QP ensure that the individuals included on commenter’s support of our proposal. snapshot date of that PY, we proposed the individual practitioner list maintain compliance with the regulation at Comment: A commenter requested that CMS would create and provide the clarification on the RO Model’s status as new Dual participant or Professional § 424.516, including notifying CMS of any reportable changes in status or an Advanced APM. Specifically, this participant with an individual commenter stated that its radiation practitioner list. information (84 FR 34522–34523). We proposed that the certified individual oncologists are part of a larger multi- In order to certify the list, we practitioner list would be used for specialty practice that currently reports proposed that an individual with the purposes related to QP determinations to CMS under the MIPS program. The authority to legally bind the RO as specified in 42 CFR part 414 subpart commenter requested clarification on participant must certify the accuracy, O. We also stated that if the Dual whether the entire group would be completeness, and truthfulness of the participant or Professional participant participating as an Advanced APM list (84 FR 34522). We proposed that the did not verify and certify the individual Entity or just the radiation oncologists. certified individual practitioner list practitioner list by the deadline Response: In the proposed rule, we would include all individual specified by CMS, the unverified list proposed that we will provide RO practitioners who have reassigned their would be used for scoring under MIPS participants with an individual rights to receive Medicare payment for using the APM scoring standard (84 FR practitioner list. We also proposed a the provision of RT services to the TIN 34523). We proposed to codify these process whereby RO participants would of the RO participant. We proposed that provisions relating to the individual review, have the opportunity to modify, the individual with the authority to practitioner list at § 512.217. and certify this list. The certified list bind the RO participant must agree to We proposed that in order to be an that includes only physician radiation comply with the requirements of the RO Advanced APM, the RO Model must oncologists who have reassigned their Model before the RO participant meet the criteria specified in our rights to receive Medicare payment for certifies the list. We note that we did regulation at 42 CFR 414.1415 (84 FR the provision of RT services to the TIN not propose that HOPDs that are 34523). First, in order to be an of the RO participant would be used for Technical participants be a part of this Advanced APM, an APM must require purposes related to QP determinations list process because as HOPDs they are participants to use certified EHR as specified in 42 CFR part 414 subpart paid by OPPS, which is not subject to technology (CEHRT). For QP O. Only those individual practitioners the Quality Payment Program. The RO Performance Periods beginning in 2019, included on the certified list would be participants may make changes to the to meet this requirement, an Advanced considered participants under the RO individual practitioner list that has been APM must require at least 75 percent of Model for purposes of the Quality certified at the beginning of the eligible clinicians in the APM Entity or, Payment Program, including identifying performance year. In order to make for APMs in which HOPDs are the APM eligible clinicians who would be eligible additions to the list, we proposed that Entities, each HOPD, to use CEHRT to to attain QP status under the Model. On the RO participant must notify CMS document and communicate clinical further reflection, we have reconsidered within 15 days of an individual care to their patients or other health care our statement in the proposed rule that practitioner becoming a Medicare- providers pursuant to 42 CFR an unverified list would be used for enrolled supplier that bills for RT 414.1415(a)(1)(i). We proposed that scoring under MIPS. After further services under a billing number during the Model performance period, consideration, we are concerned that assigned to the TIN of the RO the RO participant would be required to use of an unverified list might result in participant; the timely addition would annually certify its intent to use CEHRT incorrect or unauthorized payments and be effective on the date specified in the throughout such model year in a adjustments under the Quality Payment notice furnished to CMS, but not earlier manner sufficient to meet the Program, potentially jeopardizing than 15 days before the date of the requirements pursuant to 42 CFR program integrity. notice. If the RO participant fails to 414.1415(a). Further, we proposed that Comment: A couple of commenters submit timely notice of the addition, the within 30 days of the start of PY1, the opposed the processes proposed around addition would be effective on the date RO participant would be required to the Individual Practitioner List. One of the notice. We proposed that the certify its intent to use CEHRT commenter opposed the proposal that

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the Individual Practitioner List must be commenter’s proposed 60-day period commenters recommended that the reviewed and certified annually, stating and our original 15-day proposal. edition that RO uses should align with that this was too great an administrative Comment: A few commenters stated other quality reporting programs. This burden for participants. Another that some practices may need a commenter also questioned why commenter requested that CMS allow hardship exemption from the proposed participants must certify their intent to participants to have 60 days to notify Model requirements to use the 2015 use CEHRT at the beginning of the CMS of changes to the QP list, rather Edition CEHRT due to insufficient performance year, and not at the end. than 15 days as proposed. This internet connectivity, extreme and Response: In the RO Model, we have commenter suggested that if RO uncontrollable circumstances, or lack of proposed to align our CEHRT participants meet this 60-day reporting control over the availability of CEHRT. requirements with the regulatory deadline, the changes would take effect One of these commenters stated that requirements of the Quality Payment as of the effective date specified in the low-volume practices are excluded from Program as stated at 42 CFR 414.1415(a). notice to CMS. If participants do not the Quality Payment Program’s Merit- This relies on the definition of CEHRT meet this deadline, then addition or based Incentive Payment System (MIPS) as defined, and periodically updated, at removal would be effective on the date and its Promoting Interoperability 42 CFR 414.1305, which currently that the participant notifies CMS. performance category requirement to specifies the use of 2015 Edition Base Response: We disagree with the use 2015 Edition CEHRT, which is a EHR edition (as defined at 45 CFR commenter who believes the annual proposed requirement for the RO Model. 170.102) and has been certified to the certification process of the individual This commenter further maintained that 2015 Edition health IT certification practitioner list is unduly burdensome. including low-volume practices in the criteria. Using this definition of CEHRT We have proposed this certification RO Model would require these aligns RO Model requirements with the process so that the RO participant practices, which haven’t had to use requirements of the Quality Payment would have the chance to review and 2015 Edition CEHRT under MIPS, to Program as well as other Advanced verify that the list we intend to use for make significant financial investments APMs being tested by the Innovation QP determinations is accurate, and if it in technology and substantial time Center. We believe certifying an intent is not accurate, to notify us of the investments in software installations to use CEHRT at the beginning of the inaccuracies so a correct list can be used and training while adapting to the new performance year, as opposed to the end for those determinations. We proposed value-based reimbursement of the performance year, is appropriate methodology, which would be this process to limit burden on RO and it aligns with requirements in other detrimental to these practices’ ability to participants, as we will be creating a Advanced APMs being tested by the continue operations and reduce access draft version for their review rather than Innovation Center. for patients to receive radiation therapy. asking RO participants to draft and This commenter also stated that After considering public comments, compile a list for our review that would practices with insufficient internet we are finalizing with modification our then need to be certified. Further, we connectivity, which are typically proposals relating to the RO Model as an proposed that if the RO participant does located in rural areas, are allowed to Advanced APM regarding the CEHRT not certify the list we will still use the annually apply for a hardship exception and Participation List requirements. We uncertified list for MIPS scoring. While from the MIPS Promoting clarify that MIPS eligible clinicians we had previously proposed to still use Interoperability performance category identified on the Participation List of an an uncertified list, we are not finalizing and its requirement to use 2015 Edition APM Entity participating in a MIPS this provision. Upon further CEHRT, and if these practices are APM for the performance period are consideration and based on included in the RO Model, they will be eligible to be scored as part of an APM commenters’ requests for clarity around forced to invest significant resources Entity group, as described at 42 CFR the RO Model’s status as an Advanced and time as participants of the RO 414.1305. We are also finalizing, with APM, we are instead finalizing that RO Model and could be forced to modification, that if the Dual participant participants on an uncertified list would discontinue operations, decreasing or Professional participant does not not be considered participants in an access to cancer treatment options for verify and certify the individual APM Entity for purposes of the Quality patients. practitioner list by the deadline Payment Program as defined at Response: There are very few RT specified by CMS, RO participants on § 414.1305. We are codifying these providers and RT suppliers in these the unverified list are not recognized as provisions relating to the individual rural areas such that, if included in the participants in an APM Entity for practitioner list at § 512.217. RO Model, the rural areas would likely purposes of the Quality Payment We also disagree with the commenter not generate enough episodes to be Program. We have codified at who proposed that RO participants included in the Model. As such, we § 512.217(a) that we will create and should have 60 days to notify us of believe that our proposed CEHRT provide each Dual participant and changes to their individual practitioner requirements are not unduly Professional participant with an list. However, we agree that 15 days burdensome for rural RT providers and individual practitioner list, upon the may be an insufficient period of time for RT suppliers, and a hardship exemption start of each performance year. We have participants to review, correct, and from the CEHRT requirement is made edits to § 512.217(b) for clarity return the list to us. We will modify this unnecessary. We would note that while and readability. That provision has been proposal to allow for a 30-day period. we do not believe a hardship exemption revised to state that, within 30 days of We believe 30 days will be a sufficient is necessary for the CEHRT requirement, receipt of the individual practitioner amount of time for RO participants to we are finalizing in section III.C.3.c a list, the RO participant must review the review and submit corrections, as other low volume opt-out that may help individual practitioner list, correct any models currently being tested by the address these commenters’ concerns. inaccuracies in accordance with to Innovation Center also require 30-day Comment: A couple of commenters § 512.217(d), and certify the list (as period to review and return similar lists. requested clarification on which edition corrected, if applicable) in a form and Further, we believe 30 days is a of CEHRT CMS is requiring for RO manner specified by CMS and in reasonable compromise between the participants to use. One of these accordance with § 512.217(c).

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We have also made edits to APM’s first QP Performance Period. We payment, and therefore, would be at 100 § 512.217(d) for clarity and readability. noted in the proposed rule that there percent risk for all expenditures in This provision has been revised to state currently are no such outcome measures excess of the expected amount of that, the RO participant must notify available or applicable for the RO expenditures, which are the previously CMS of a change, including additions or Model’s first QP Performance Period (84 discussed episode payments. As removals, to its individual practitioner FR 34523). If a potentially relevant proposed, RO participants would not list within 30 days. Further, we have outcome measure becomes available, we receive any additional payment or clarified at § 512.217(d)(2)(i) that the would consider it for inclusion in the reconciliation from CMS (beyond the removal of an individual practitioner RO Model’s measure set. participant-specific professional episode from the RO participant’s individual The third criterion to be an Advanced payment or participant-specific practitioner list is effective on the date APM is that the APM must require technical episode payment) to account that the individual ceases to be an participating APM Entities to bear for any additional medically necessary individual practitioner as defined at financial risk for monetary losses of RT services furnished during the 90-day § 512.205. more than a nominal amount or, be a episode. Effectively, this means that Next in the proposed rule, at 84 FR Medical Home Model expanded under when actual expenditures for which the 34523, we explained the second the Innovation Center’s authority, in APM Entity was responsible under the criterion to be an Advanced APM, accordance with section 1115A(c) of the APM exceed expected expenditures, the which is that an APM must include Act. As we stated in the proposed rule, RO participant would be responsible for quality measure performance as a factor we expect that the RO Model will meet 100 percent of those costs without any when determining payment to the generally applicable financial risk stop-loss or cap on potential losses. This participants for covered professional standard in accordance with 42 CFR would satisfy the requirement under 42 services under the terms of the APM as 414.1415 because there is no minimum CFR 414.1415(c)(3)(i)(B) because, for specified at 42 CFR 414.145(b)(1). (or maximum) financial stop-loss for RO example, if actual expenditures are 3 Effective January 1, 2020 at least one of participants, meaning RO participants percent more, or 5 percent more, or 7 the quality measures upon which the would be at risk for all of the RT percent more than the expected APM bases payment must meet at least services beyond the episode payment expenditures for which an RO one of the following criteria: (a) amount (84 FR 34523). participant is responsible under the Finalized on the MIPS final list of The regulation at 42 CFR model, the RO participant is 100 percent measures, as described in 42 CFR 414.1415(c)(1) requires that ‘‘to be an liable for those additional 3 percent, 5 414.1330; (b) endorsed by a consensus- Advanced APM, an APM must, based percent, or 7 percent of costs without based entity; or (c) determined by CMS on whether an APM Entity’s actual any limit to the total amount of losses to be evidenced-based, reliable, and expenditures for which the APM Entity they may incur. valid. is responsible under the APM exceed Additionally, as we stated in the We noted in the proposed rule that we expected expenditures during a proposed rule (84 FR 34523–34524), we discussed the RO Model’s quality specified QP Performance Period, do anticipated that the RO Model would measure set in section III.C.8.b of the one or more of the following: (i) meet the criteria to be a MIPS APM proposed rule. We discussed our Withhold payment for services to the under the Quality Payment Program intention to use the results of the APM Entity or the APM Entity’s eligible starting in PY1 (January 1, 2020) if the following quality measures when clinicians; (ii) Reduce payment rates to start date is finalized as January 1, 2020 determining payment to Professional the APM Entity or the APM Entity’s or in PY2 (January 1, 2021) if finalized participants and Dual participants eligible clinicians; or (iii) Require the as April 1, 2020. MIPS APMs, as defined under the terms of the RO Model, as APM Entity to owe payment(s) to CMS.’’ in 42 CFR 414.1305, are APMs that meet discussed in detail in section III.C.8.f of We stated in the proposed rule that the the criteria specified under 42 CFR the proposed rule and this final rule: (1) RO Model would meet this standard 414.1370(b). Currently, pursuant to 42 Oncology: Medical and Radiation—Plan because CMS would not pay the RO CFR 414.1370(a), MIPS eligible of Care for Pain; (2) Preventive Care and participant more for RT services than clinicians who are identified on a Screening: Screening for Depression and the episode payment amount (84 FR Participation List for the performance Follow-Up Plan; and (3) Advance Care 34523). period of an APM Entity participating in Plan; and (4) Treatment Summary The regulation at 42 CFR a MIPS APM are scored under MIPS Communication—Radiation Oncology. 414.1415(c)(3) sets the standard for a using the APM scoring standard. We The quality measures we proposed to nominal amount of risk for Advanced proposed to use the same individual use for the RO Model are measures that APMs other than Medical Home Models practitioner list developed to identify are either finalized on the MIPS final at either ‘‘eight percent of the average the relevant eligible clinicians for list of measures, or determined by CMS estimated total Medicare Parts A and B purposes of making QP determinations to be evidence based, reliable, and valid. revenues of participating APM Entities’’ and applying the APM scoring standard As we indicated in the proposed rule, for QP Performance Periods in 2017 under the Quality Payment Program. we believe that these measures would through 2024 or ‘‘three percent of the In the CY 2021 PFS proposed rule, we meet the criteria under 42 CFR expected expenditures for which the proposed to terminate the APM scoring 414.1415(b) (84 FR 34523). APM Entity is responsible for under the standard effective January 1, 2021 (85 In addition to the quality measure APM’’ for all QP Performance Periods. FR 50303). We also proposed to requirements listed earlier, under 42 For the RO Model, as we discussed in establish a new APM Performance CFR 414.1415(b)(3), the quality the proposed rule (84 FR 34523), the Pathway, which, if finalized, would be measures upon which an Advanced APM Entities would be at risk for all an optional MIPS reporting and scoring APM bases payment must include at costs associated with RT services as pathway for MIPS eligible clinicians least one outcome measure. This discussed in section III.C.5.c of the identified on the Participation List or requirement does not apply if CMS proposed rule and this final rule beyond Affiliated Practitioner List of a MIPS determines that there are no available or those covered by the participant-specific APM (85 FR 50285). We also proposed applicable outcome measures included professional episode payment or the to allow APM Entities to report to MIPS in the MIPS quality measures list for the participant-specific technical episode via any available submission

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mechanism, on behalf of all MIPS runs counter to the majority of CMS established various levels of risk at and eligible clinicians in the APM Entity APMs such as the BPCI Advanced above these minimum amounts. As group (85 FR 50304). If these proposals Model, the CJR Model, the Shared such, we believe that the level of risk we are finalized in the forthcoming CY Savings Program, and OCM, which all have established for the RO Model, is 2021 PFS final rule, MIPS eligible cap downside risk. These commenters above the minimum level specified in clinicians participating in the RO Model suggest that CMS should establish a the generally applicable nominal would have the option to report to MIPS stop-loss provision to mitigate this high amount standard that we established for using the APM Performance Pathway, degree of risk and to ensure that the RO the Quality Payment Program. and they would have the option to Model does not place substantial Furthermore, the level of risk is report to MIPS as individuals, groups, or financial burden on RO participants. A appropriate and in line with the levels APM Entities. commenter suggested implementing a of risk of other Advanced APMs being In the proposed rule we noted that the stop-loss provision using the encounter tested by the Innovation Center, following proposals would apply to any data CMS proposes to require including the stop-loss policy described APM Incentive Payments made for participants to submit. in section III.C.6e(4) The stop-loss limit eligible clinicians who become QPs Response: We appreciate the of 20 percent aligns with stop-loss limits through participation in the RO Model: commenters’ concerns and feedback set by other models such as the BPCI • Our proposals regarding around the level of risk in the RO Advanced and CJR Models. Further, we monitoring, audits and record retention, Model, and regarding a stop-loss would like to note that the RO Model and remedial action, as discussed in provision under the Model. We believe does have two-sided risk; participants section II.F and III.C.14 of the proposed that the heavy weight of the RO that provide services more efficiently rule. Under our monitoring policy, RO participants’ historical experience in than the RO episode price yield savings, participants would be monitored for their participant-specific RO payment while those that provide services less compliance with the RO Model amount, combined with the low volume efficiently than the RO episode price requirements. CMS may, based on the opt-out option (see section III.C.3.c), yield losses. results of such monitoring, deny an minimizes the potential losses that an Comment: A commenter requested eligible clinician who is participating in RO participant may face. However, we that providers and suppliers that are the RO Model QP status if the eligible understand that there are some required to participate in the RO Model clinician or the eligible clinician’s APM circumstances where RO participants should have every possible assurance entity (that is, the respective RO that have fewer than 60 episodes in the that their participation will qualify them participant) is non-compliant with RO baseline period will not qualify to for exemption from MIPS and will earn Model requirements. receive a historical experience them the APM incentive for • Our proposal in section III.C.10.c, of adjustment and may experience participation in an Advanced APM. the proposed rule which explains that significant increases or reductions to This commenter stated that they technical component payments under what they were historically paid in FFS. understand that CMS cannot guarantee the RO Model would not be included in We are adopting a stop-loss limit of 20 that providers and suppliers will meet the aggregate payment amount for percent to the RO Model for these RO the minimum payment or patient covered professional services that is participants that were furnishing volume requirement to be a qualifying used to calculate the amount of the included RT services in the CBSAs participant, but the agency should APM Incentive Payment. selected for participation at the time of We solicited comment on our the effective date of this final rule. finalize a structure that squarely proposals. The following is a summary Please reference section III.C.6.e(4) for satisfies each of the requirements for an of the public comments received on more information on the stop-loss Advanced APM. these proposals and our responses: policy. Response: We appreciate the Comment: A few commenters We understand the commenters’ commenter’s views on the design of the expressed concern regarding the risk concerns with the level of risk in this RO Model as an Advanced APM. We that will be involved for participants in Model compared with other Innovation believe that we have designed the the RO Model. A commenter stated that Center models. Section 1833(z)(3)(D) of Model in such a way that we expect that if the RO Model is structured as largely the Act, as added by the Medicare the RO Model will be determined to be as proposed, then participation will be Access and CHIP Reauthorization Act both an Advanced APM and a MIPS a significant, risky, and costly (MACRA) of 2015 (Pub. L. 114–10), APM starting on January 1, 2021. As undertaking. One of these commenters established certain requirements for such, all eligible clinicians participating requested that CMS redesign the Model APMs including a requirement that an in the RO Model will have the payment to allow for two-sided risk. APM Entity bear financial risk for opportunity to become QPs or Partial Another commenter expressed concern monetary losses that are in excess of a QPs based on meeting the relevant with the lack of a cap on downside risk nominal amount or be a medical home payment or patient count thresholds, and opposed the current, uncapped risk expanding under 111A(c) of the Act. In and thereby exempt from the MIPS structure. This commenter suggested rulemaking, we have established this reporting requirements and payment that the RO Model should establish risk generally applicable nominal amount adjustment for the relevant year. Under at the levels finalized by CMS for other standard to mean that an Advanced the structure of the Quality Payment APMs. A few commenters requested APM must put the APM Entities at risk Program, not all eligible clinicians in that CMS include stop-loss provisions for at least eight percent of the average the RO Model will necessarily achieve in the RO Model. These commenters estimated total Medicare Parts A and B QP status or earn an APM Incentive stated that RO Participants would bear revenue of all providers and suppliers Payment for their participation in the 100 percent of the risk for all RT participating APM Entities or at least 3 Advanced APM, but we believe there services provided in excess of the percent of the expected expenditures for are other inherent benefits to the RO bundle payments, and that this high which an APM Entity is responsible participant. Furthermore, based on our degree of risk is inappropriate for a under the APM, as codified in actuarial analysis we believe that most mandatory model. They also maintained § 410.1415(c)(3). In designing and eligible clinicians will achieve QP status that this lack of stop-loss protection implementing other models, we have during the course of the RO Model.

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Other benefits for participating in the and PC portions of an episode. MedPAC requirements pursuant to 42 CFR RO Model as it is designed as an further disagreed with CMS’ decision to 414.1415(a). Further, within 30 days of Advanced APM and a MIPS APM not propose any outcome measures for the start of PY1, the RO participant will include a chance to be an early adopter the Model, and they disagree with CMS’ be required to certify its intent to use of a value-based payment arrangement determination that there are currently CEHRT throughout such model year in model. As CMS in general, and the no outcome measures available or a manner sufficient to meet the health care industry specifically, turns applicable for the RO Model. MedPAC requirements pursuant to 42 CFR to more value-based payment states that OCM uses three claims-based 414.1415(a). arrangements, early adopters of these outcome measures to determine Payment based on MIPS-comparable models may have an advantage over performance-based payments: Risk- quality measures: We intend to use the their peers who have not participated in adjusted proportion of patients with all- results of the following quality measures these models. Additionally, eligible cause hospital admissions within the when determining payment to clinicians in the RO Model who are six-month episode, risk-adjusted Professional participants and Dual MIPS eligible clinicians (those not proportion of patients with all-cause participants under the terms of the RO excluded from MIPS as QPs, Partial emergency department (ED) visits or Model, as discussed in detail in section QPs, or on another basis) will be observation stays that did not result in III.C.8.f of this final rule: (1) Oncology: considered participants in a MIPS APM a hospital admission within the six- Medical and Radiation—Plan of Care for for purposes of MIPS reporting and month episode, and proportion of Pain; (2) Preventive Care and Screening: scoring rules. patients that died who were admitted to Screening for Depression and Follow- Up Plan; and (3) Advance Care Plan; Comment: MedPAC did not support hospice for three days or more. MedPAC and (4) Treatment Summary CMS’ proposal that the RO Model stated that CMS should consider using Communication—Radiation Oncology. would qualify to be an Advanced APM. similar outcome measures for the RO Further, the quality measures we use for MedPAC stated that the RO Model does Model, as both OCM and the RO Model the RO Model are measures that are not meet two of the principles that focus on cancer treatment. They also either finalized on the MIPS final list of MedPAC has developed for Advanced stated that use of claims-based outcome measures in the RO Model would enable measures, or determined by CMS to be APMs: Clinicians should receive a 5 CMS to hold providers and suppliers evidence-based, reliable, and valid. In percent incentive payment only if the accountable for the quality of their care addition to the quality measure eligible entity in which they participate and allow CMS to evaluate whether requirements listed earlier, under 42 is successful in controlling cost, prospective episode payments for RT CFR 414.1415(b)(3), the quality improving quality, or both; and the services reduce spending without measures upon which an Advanced eligible entity should be at financial risk causing negative outcomes. Finally, APM bases payment must include at for total Part A and Part B spending. MedPAC stated that claims-based least one outcome measure. This MedPAC stated that incentive payments outcome measures, such as readmission requirement does not apply if CMS should not be awarded for simply rates, do not impose a reporting burden determines that there are no available or participating in an APM entity but on providers and suppliers and are part applicable outcome measures included should be contingent on quality and of MIPS. in the MIPS quality measures list for the spending performance. They stated that Response: We appreciate MedPAC’s APM’s first QP Performance Period. the RO Model does not follow this first analysis of the Quality Payment CMS has determined that there principle, as clinicians who participate Program and the RO Model, but we currently are no such outcome measures in the RO Model through an eligible disagree that the RO Model should not available or applicable for the RO entity and have a sufficient share of qualify as an Advanced APM. We Model’s first QP Performance Period. revenue coming through the Model believe the additional principles that Furthermore, with regards to would receive an incentive payment, MedPAC has established can be used as MedPAC’s comments about the RO whether or not the entity limits costs analytic tools when analyzing Advanced Model using similar outcome measures per episode or improves quality. APMs, they do not align with or take the that are employed by OCM, we thank MedPAC also stated that the RO Model place of the statutory criteria for APMs MedPAC for the suggestion. We does not follow their second principle, and eligible APM Entities established in considered using the same OCM to help move the fee-for-service (FFS) § 1833(z)(3)(C) and (D) of the Act and outcome measures for the RO Model, payment system from volume to value, codified at 42 CFR 414.1415, and as but ultimately decided that it would be encourage care coordination, and more such are not necessary requirements difficult to discern whether these broadly reform the delivery system, as when making an Advanced APM outcomes occurred due to complications the RO Model entities are only determination. Specifically, as codified from RT services, chemotherapy by responsible for spending on certain RT at 42 CFR 414.1415, the criteria for medical oncologists, or for other various services within a 90-day episode of care. Advanced APMs are as follows: (1) The reasons. As such, we believe that these They are not held accountable for APM requires use of CEHRT, (2) measures would not meaningfully spending on other services provided to payment under the APM is based on indicate high- versus low-quality RO beneficiaries in the Model, such as E&M MIPS-comparable quality measures, and participants. visits, tests, ED visits, or hospital (3) the APM requires participants to Financial Risk: The regulation at 42 admissions. Entities would also have an assume more than nominal financial CFR 414.1415(c)(1) requires that ‘‘to be incentive to reduce the cost per episode risk. As articulated in this section of this an Advanced APM, an APM must, based while increasing the total number of final rule, we believe that the RO Model on whether an APM Entity’s actual episodes. In addition, there is not a satisfies each of these criteria. expenditures for which the APM Entity single entity that would be responsible Required use of CEHRT: During the is responsible under the APM exceed for episode spending because CMS Model performance period, the RO expected expenditures during a would make separate episode payments participant will be required to annually specified QP Performance Period, do for the TC and PC portions of the certify its intent to use CEHRT one or more of the following: (i) episode, unless an entity is a Dual throughout such model year in a Withhold payment for services to the participant that provides both the TC manner sufficient to meet the APM Entity or the APM Entity’s eligible

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clinicians; (ii) Reduce payment rates to are limited to the total amount of losses requirement in the Quality Payment the APM Entity or the APM Entity’s they may incur because they are eligible Program that one entity must be at risk eligible clinicians; or (iii) Require the for the stop-loss policy, that limit is set for the entire cost of the episode. As we APM Entity to owe payment(s) to CMS.’’ to 20 percent of expected expenditures have previously stated, in the RO Model As we explained in the proposed rule for which the RO participants are we are specifically testing different and in this section of the final rule, the responsible for under the RO Model. pricing methodologies for the RT RO Model would meet this standard Finally, while MedPAC has created services provided, not the other costs because CMS would not pay the RO these additional principles that it associated with the beneficiary. participant more for RT services than believes should be achieved for a model Comment: A commenter suggested the episode payment amount. to be an Advanced APM, these that CMS should structure the final RO The regulation at 42 CFR additional principles have not been Model so that all RO participants will be 414.1415(c)(3) sets the standard for a codified in the Quality Payment QPs in an Advanced APM for purposes nominal amount of risk for Advanced Program regulations as necessary of the Quality Payment Program, APMs other than Medical Home Models requirements of Advanced APMs. Even assuming minimum participation at either ‘‘eight percent of the average though meeting these principles is not requirements are met. Additionally, estimated total Medicare Parts A and B a requirement for Advanced APM although we did not request comments revenues of participating APM Entities’’ status, we are responding to these on our projection, discussed further in for QP Performance Periods in 2017 comments to better explain our section VII.C.3 of the Regulatory Impact reasoning behind the RO Model being Analysis, that 83 percent of physician through 2024 or ‘‘three percent of the proposed as an Advanced APM. participants, measured by their unique expected expenditures for which the First, regarding the APM Incentive NPI, would achieve QP status and APM Entity is responsible for under the Payment, MedPAC believes the APM receive the APM Incentive Payment APM’’ for all QP Performance Periods. incentive payment should only be paid under the Quality Payment Program at For the RO Model, most APM Entities, if the APM participant is successful in some point (for at least one QP with the exception of those RO controlling cost, improving quality, or Performance Period) during the Model participants that qualify for the stop-loss both, and if the APM participant is at performance period, some commenters policy as described in section III.C.6.e(4) financial risk for total Part A and Part suggested that all physicians and codified at § 512.285(f), would be at B spending. The Quality Payment participating in the RO Model should risk for all costs associated with RT Program statute and regulations provide receive the APM incentive payment as services (described in section III.C.5.c of different standards for eligible clinicians compensation for participation in a this final rule) beyond those covered by to earn an APM incentive payment, and mandatory model that requires quality the participant-specific professional for an APM to be considered an measure and clinical data reporting. episode payment or the participant- Advanced APM, based on the required Commenters stated that CMS was specific technical episode payment, and assumption of financial risk; the Quality issuing an unfunded mandate in cases therefore, would be at 100 percent risk Payment Program provides for the APM where physicians did not receive the for all expenditures in excess of the incentive payment to encourage APM Incentive Payment. expected amount of expenditures, clinicians to move into value-based Response: Under the structure of the which are the previously discussed payment through Advanced APMs. Quality Payment Program, not all episode payments. RO participants Additionally, in the RO Model we are eligible clinicians will necessarily earn would not receive any additional specifically testing different pricing an APM Incentive Payment for their payment or reconciliation from CMS methodologies for the RT services participation in an Advanced APM. (beyond the participant-specific provided, not the other costs associated Specifically, in accordance with 42 CFR professional episode payment or with the beneficiary’s care. 414.1430, eligible clinicians must participant-specific technical episode Second, regarding the move from FFS achieve certain threshold levels of payment) to account for any additional payments to a value-based payment participation in the Advanced APM in medically necessary RT services system, MedPAC believes that since RO terms of payment amounts or patient furnished during the 90-day episode. participants are only held accountable counts in order to achieve QP status and Effectively, this means that when actual for spending on certain RT services qualify for an APM Incentive Payment. expenditures for which the APM Entity within the episode of care and not held Therefore, we believe there are other was responsible under the APM exceed accountable for spending on other inherent benefits to the RO participant expected expenditures, the RO services provided to the RO beneficiary, including the chance to be an early participant would be responsible for 100 the RO participants are not properly adopter of a value-based payment percent of those costs without any stop- incentivized to reduce the total cost of arrangement. As CMS in general, and loss or cap on potential losses, except care. We generally disagree that such the health care industry specifically, for the participants that qualify for the broad incentives are necessary for turns to more value-based payment stop-loss policy, as previously stated. Advanced APM status. Specifically, the arrangements, early adopters of these This would satisfy the requirement Advanced APM criterion codified at 42 models will have an advantage over under 42 CFR 414.1415(c)(3)(i)(B) CFR 414.1415(c) does not specify that a their peers who have not participated in because, for example, if actual financial risk must be based on a total these models. Additionally, eligible expenditures are 3 percent more, or 5 cost of care arrangement. Additionally, clinicians in the RO Model who are percent more, or 7 percent more than we did not design the RO Model to be MIPS eligible clinicians (those not the expected expenditures for which RO a total cost of care model. Instead it was excluded from MIPS as QPs, Partial participants are responsible under the designed so that each RO episode only QPs, or on another basis) will be Model, RO participants are 100 percent covers RT services. We limited the considered participants in a MIPS APM liable for those additional 3 percent, 5 Model in this way because we believe for purposes of MIPS reporting and percent, or 7 percent of costs. Most that these services are in the control of scoring rules. participants are without any limit to the the RT provider and RT supplier, and We appreciate the comments on our total amount of losses they may incur. they are the entities at risk in the Model. QP projections, but we must use the For the subset of RO participants that Further, there has never been a APM Incentive Payment calculation

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methodology as specified at 42 CFR determinations of Advanced APMs and Quality Payment Program. We also 414.1450 to determine which eligible MIPS APMs for the 2021 performance clarify that currently, MIPS APMs, as clinicians meet the QP threshold period will be announced via the defined in 42 CFR 414.1305, are APMs required to achieve QP status and Quality Payment Program website at that meet the criteria specified under 42 receive the APM Incentive Payment. As https://qpp.cms.gov/. We are finalizing CFR 414.1370(b). As indicated in the such, just as we cannot summarily our proposal to use the results of the current 42 CFR 414.1370(a), participants award QP status to all RO participants, following quality measures, finalized in in a MIPS APM are those MIPS eligible we cannot automatically make an APM section III.C.8.b of this final rule, when clinicians who are identified on a Incentive Payment to all eligible determining payment to Professional Participation List of an APM Entity clinicians in the RO Model. All eligible participants and Dual participants participating in a MIPS APM for the clinicians are required to meet the QP under the terms of the RO Model, as performance period. We are using the threshold for Medicare Part B discussed in detail in section III.C.8.f: same individual practitioner list professional services payments or (1) Oncology: Medical and Radiation— developed to identify the eligible patients in an Advanced APM in order Plan of Care for Pain; (2) Preventive clinicians in the APM Entity for to achieve QP status and receive the Care and Screening: Screening for purposes of the Quality Payment APM incentive payment. In addition to Depression and Follow-Up Plan; and (3) Program. the 83 percent of RO Model physicians Advance Care Plan; and (4) Treatment We also note that we are finalizing who are expected to be QPs, 9 percent Summary Communication—Radiation that all requirements concerning the are expected to be partial QPs at some Oncology. As there currently are no review and certification of the point during the Model performance available or applicable outcome individual practitioner list will be period, resulting in 92 percent of RO measures included in the MIPS quality required in PY1 (beginning January 1, Model physicians becoming QPs or measures list for the RO’s Model’s first 2021). This includes the requirement partial QPs at some point. We would QP Performance Period, we will not be that Dual participants and Professional note that while partial QPs do not earn including an outcome measure in this participants must review and certify the the APM Incentive Payment, they do final rule. However, if a potentially first individual practitioner list within have the option to decide whether to be relevant outcome measure becomes 30 days of receiving the list upon the subject to the MIPS reporting available, we would consider whether start of PY1. Further, we are finalizing requirements and payment adjustment, such an outcome measure should be as proposed, and codified at which would otherwise be required. included in the RO Model’s measure set, § 512.220(b), that participants must use Comment: A commenter requested and if so, use notice and comment certified EHR technology (CEHRT), that that the 5 percent APM incentive rulemaking to propose adding it. the RO participant must annually certify payment that is available through 2024 We are finalizing with modification, its intent to use CEHRT during the should be extended as the RO Model is that most APM Entities, the RO Model performance period, and that the just becoming available to radiation participants, with the exception of those RO participant will be required to oncologists, and prior to this, the RO participants that qualify for the stop- certify its intent to use CEHRT within radiation oncology community has not loss provision as described in (see 30 days of the start of PY1. had an Advanced APM available that section III.C.6.e(4) and codified at would qualify physicians in the § 512.285(f), will be at risk for all costs Finally, we note that the following radiation oncology specialty for this associated with RT services, as defined provisions being finalized in other bonus. in section III.C.5.c of this final rule, sections of this final rule will apply to Response: We appreciate the beyond those covered by the any APM Incentive Payments made for commenter’s feedback on the participant-specific professional episode eligible clinicians who become QPs availability of the APM Incentive through participation in the RO Model: payment or the participant-specific • Payment to eligible clinicians who have technical episode payment, and Our finalized provisions regarding been determined to be QPs participating therefore, will be at 100 percent risk for monitoring, audits and record retention, in Advanced APMs. The APM Incentive all expenditures in excess of the and remedial action, as described in Payment is limited based on statute to expected amount of expenditures, section II.F and III.C.14. • payment years 2019 through 2024 as which are the previously discussed Our finalized provision in section specified in section 1833(z)(1)(A) of the episode payments. As discussed earlier III.C.10.c, which explains that technical Act. in this section, based on these finalized component payments under the RO After considering public comments, provisions, the RO Model would meet Model will not be included in the we are finalizing our proposals, with the criteria to be an Advanced APM. aggregate payment amount for covered modification, that, effective January 1, Based on the changes we made to the professional services that is used to 2021, at least one of the quality start date of the Model performance calculate the amount of the APM measures upon which the RO Model period in this final rule, we anticipate Incentive Payment. bases payment will meet at least one of that the finalized RO Model will meet 10. Medicare Program Waivers the following criteria: (a) Finalized on the criteria to be a MIPS APM under the the MIPS final list of measures, as Quality Payment Program starting in As explained in the proposed rule, we described in 42 CFR 414.1330; (b) PY1 on January 1, 2021, instead of the believe it would be necessary to waive endorsed by a consensus-based entity; proposed PY1 (January 1, 2020) or PY2 certain requirements of title XVIII of the or (c) determined by CMS to be (January 1, 2021) as we had indicated in Act solely for purposes of carrying out evidenced-based, reliable, and valid. the proposed rule. We are also finalizing the testing of the RO Model under This modification means that quality with modification to use the individual section 1115A (b) of the Act. Each of the data collection and reporting for the RO practitioner list to identify the relevant waivers, which we discussed in detail, Model will begin with PY1 on January eligible clinicians for purposes of would be necessary to ensure that the 1, 2021, which means that we expect the making QP determinations and Model test’s design provides additional Model to qualify as both an Advanced determining those MIPS eligible flexibilities to RO participants, APM and a MIPS APM beginning on clinicians who are also considered including flexibilities around certain January 1, 2021. Final CMS participants in a MIPS APM under the Medicare program requirements.

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a. Waiver of Hospital Outpatient Quality dividing the reduced conversion factor participants, the calculation of how Reporting (OQR) Program Payment by the full conversion factor. We refer much each RO participant would be Adjustment to this reduction ratio as the ‘‘reporting paid for the PC and TC of the RO In the proposed rule, we stated that ratio’’ to indicate that it applies to episode is designed to be as similar as we believe that it would be necessary hospitals that fail to meet their reporting possible, irrespective of whether the RO for purposes of testing the RO Model to requirements. Applying this reporting participant is an HOPD or a freestanding waive the Hospital OQR Program ratio to the OPPS payment amounts radiation therapy center. Therefore, in payment reduction authorized under results in reduced national unadjusted the proposed rule we stated our belief section 1833(t)(17)(A) of the Act. Under payment rates that are mathematically that applying the Hospital OQR Program the Hospital OQR Program, subsection equivalent to the reduced national payment reduction would undermine (d) hospitals are required to submit data unadjusted payment rates that would our goal of site-neutral payments under on measures on the quality of care result if we multiplied the scaled OPPS the RO Model because it could affect furnished by hospitals in outpatient relative payment weights by the reduced HOPDs, but not freestanding radiation settings. Further, section conversion factor. Thus, our policy is to therapy centers, creating additional 1833(t)(17)(A)(i) of the Act states that apply the reduction of the OPD fee variables that could complicate a subsection (d) hospitals that fail to meet schedule increase factor through the use neutral comparison. As we stated in the Hospital OQR Program requirements of a reporting ratio for those hospitals proposed rule, if the requirement to that fail to meet the Hospital OQR apply the Hospital OQR Program receive a two percentage point Program requirements for a year (83 FR payment reduction were not waived, the reduction to their outpatient department 59108–59110). participant-specific technical episode (OPD) fee schedule increase factor. The In the proposed rule, we proposed payments made with respect to services fee schedule increase factor is applied that for purposes of APCs that contain furnished by RO participants in HOPDs annually to increase the OPPS RO Model-specific HCPCS codes, we that are billed under the technical RO conversion factor, which is then would waive the requirement under Model-specific HCPCS codes may be multiplied by the relative payment section 1833(t)(17)(A)(i) of the Act that decreased due to the Hospital OQR weight for a particular Ambulatory the Secretary reduce the OPD fee Program payment reduction. Payment Classification (APC) to schedule increase factor under section Meanwhile, the Hospital OQR Program determine the payment amount for the 1833(t)(3)(C)(iv) of the Act for a year by payment reduction would not apply to APC. Not all OPPS items and services 2.0 percentage points for a subsection participating freestanding radiation are included in APCs for which the (d) hospital that does not submit, to the therapy centers, which are paid under payment is determined using the Secretary in accordance with paragraph the PFS not OPPS. In the proposed rule, conversion factor. For this reason, we (17), data required to be submitted on we discussed our belief that the only apply the 2 percent reduction to measures selected under that paragraph potential differences between APCs—identified by status indicators— with respect to such a year. RO Model- participant-specific technical episode for which the payment is calculated by specific HCPCS codes would be mapped payments made for services furnished in multiplying the relative payment weight to RO Model-specific APCs for payment HOPDs and those made under the PFS by the conversion factor. purposes under the OPPS. This waiver that would be caused by the application Section 1833(t)(17) of the Act, which would apply only to the APCs that of the Hospital OQR Program payment applies to subsection (d) hospitals (as include only the new HCPCS codes that reduction would be problematic for the defined in section 1886(d)(1)(B) of the are created for the RO Model, rather RO Model test by creating potentially Act), states that hospitals that fail to than all APCs that package radiation misaligned incentives for RO report data required to be submitted on HCPCS codes, and would only apply participants. The Hospital OQR Program measures selected by the Secretary, in a when a hospital does not meet payment reduction may interfere with form and manner, and at a time, requirements under the Hospital OQR how the RO Model pricing methodology specified by the Secretary will incur a Program and would otherwise be subject has been conceptualized and therefore 2.0 percentage point reduction to their to the 2.0 percentage point reduction. impact the model evaluation by Outpatient Department (OPD) fee Only Technical participants using the introducing additional variability into schedule increase factor; that is, the RO Model-specific HCPCS codes would RO participants’ payments, thereby annual payment update factor. The be paid under the Model; APCs not making it harder to discern whether the national unadjusted payment rates for included in the Model, and thus not episode-based bundled payment many services paid under the OPPS using the RO Model-specific HCPCS approach is successful. equal the product of the OPPS codes, would continue to be paid under For these reasons, we believed that it conversion factor and the scaled relative the OPPS and subject to the 2.0 would be necessary to waive the payment weight for the APC to which percentage point reduction under the requirement to apply the Hospital OQR the service is assigned. The OPPS Hospital OQR Program when applicable. Program payment reduction under conversion factor, which is updated We stated in the proposed rule that we section 1833(t)(17)(A)(i) of the Act and annually by the OPD fee schedule believed this waiver would be necessary 42 CFR 414.1405(e) that may otherwise increase factor, is used to calculate the in order to equally evaluate apply to payments made for services OPPS payment rate for many services participating HOPDs and freestanding billed under the technical RO Model- under the OPPS. To reduce the OPD fee radiation oncology centers on both cost specific HCPCS codes. As such, we schedule increase factor for hospitals and quality. proposed to waive application of the 2.0 that fail to meet the Hospital OQR The RO Model is a test of a site- percentage point reduction under Program reporting requirements, we neutral pricing methodology, where section 1833(t)(17) of the Act for only calculate two conversion factors—a full payment rates are calculated in the same those APCs that include only RO Model- market basket conversion factor (that is, manner regardless of the setting (in this specific HCPCS codes during the Model the full conversion factor), and a case, HOPDs and freestanding radiation performance period. reduced market basket conversion factor therapy centers) and paid prospectively We solicited comment on our (that is, the reduced conversion factor). based on episodes of care. While proposal to waive application of the We then calculate a reduction ratio by payment amounts may vary across RO Hospital OQR Program 2.0 percentage

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point reduction through use of the technical episode payments made to that it would unfairly penalize reporting ratio for APCs that include the participating HOPDs. In the proposed clinicians for their efforts to comply new HCPCS codes that are created for rule, we stated our belief that the with MIPS requirements, particularly in the RO Model during the Model potential differences between MIPS performance years 2018 and 2019, performance period. We received no participant-specific technical episode prior to the Model start. In particular, comments, and therefore, are finalizing payments made for services furnished in clinicians who performed well in MIPS our proposal as proposed. freestanding radiation therapy centers believed that waiving MIPS payment and those made under the OPPS that adjustments would result in lower RO b. Waiver of the Requirement To Apply would be caused by the application of Model payments than they were due, the MIPS Payment Adjustment Factors the MIPS payment adjustment factors based on their positive performance in to Certain RO Model Payments would be problematic for the RO Model MIPS. As we stated in the proposed rule, test by creating potentially misaligned Response: We understand under section 1848(q)(6)(E) of the Act incentives for RO participants as well as commenters’ concerns regarding fair and 42 CFR 414.1405(e), the MIPS other challenges for the Model payment for participation in MIPS. payment adjustment factor, and, as evaluation. Further we stated our belief Upon further consideration, we are not applicable, the additional MIPS that without this waiver, RO finalizing our proposal to waive the payment adjustment factor (collectively participants may be incentivized to MIPS payment adjustment factors for referred to as the MIPS payment change their behavior and steer the PC of RO Model payments. We adjustment factors) generally apply to beneficiaries towards freestanding believe the concerns raised by the amount otherwise paid under radiation therapy centers if they expect commenters outweigh our original Medicare Part B with respect to covered the MIPS payment adjustment factors policy rationale in that CMS does not professional services furnished by a will be positive, and away from want to create a general disincentive for MIPS eligible clinician during the freestanding radiation therapy centers if participation in Advanced APMs by applicable MIPS payment year. We they expect the MIPS payment waiving MIPS Adjustments that may proposed to waive the requirement to adjustment factors will be negative. positively impact RO participants’ apply the MIPS payment adjustment Dual and professional RO participants payments. As such, we are finalizing factors under section 1848(q)(6)(E) of that bill for the participant-specific that the MIPS payment adjustment the Act and 42 CFR 414.1405(e) that professional episode payments for RT factors will apply to participant-specific may otherwise apply to payments made services using RO Model-specific professional episode payments for the for services furnished by a MIPS eligible HCPCS codes will be subject to payment PC of RT services furnished by a MIPS clinician and billed under the adjustments under the Model based on eligible clinician. The MIPS payment professional RO Model-specific HCPCS quality performance through the quality adjustment factors will also continue to codes because we believed that it would withhold. The MIPS payment apply to RO participants’ payments for be necessary solely for purposes of adjustment factors are determined in covered professional services furnished testing the RO Model. part based on a MIPS eligible clinician’s by a MIPS eligible clinician that are The RO Model is a test of a site- performance on quality measures for a outside the RO Model as they usually neutral pricing methodology, where performance period. In the proposed would. Because we expect that the RO payment rates are calculated in the same rule, we stated our belief that subjecting Model will be an Advanced APM, we manner regardless of the setting and an RO participant to payment anticipate that many eligible clinicians paid prospectively based on episodes of consequences under both MIPS and the in the Model will achieve the Qualifying care. While payment amounts may vary Model for potentially the same quality APM Participant (QP) threshold and across RO participants, the calculation performance could have unintended will be excluded from MIPS, starting in of how much each RO participant consequences. The MIPS payment QPP performance year 2021 (payment would be paid for the PC and TC of the adjustment factors may interfere with year 2023). RO episode is designed to be as similar how the RO Model pricing methodology After considering public comments, as possible, irrespective of whether the has been conceptualized and therefore we are finalizing our proposal at RO participant is an HOPD or a impact the model evaluation by § 512.280(c) with modification to only freestanding radiation therapy center. introducing additional variability into waive the MIPS payment adjustment Therefore, in the proposed rule we RO participants’ payments thereby factors for the TC of RO Model stated our belief that applying the MIPS making it harder to discern whether the payments. We are not finalizing our payment adjustment factors would episode-based bundled payment proposal to waive the MIPS payment undermine our goal of site-neutral approach is successful. For these adjustment factors for the PC of RO payments under the RO Model. reasons, in the proposed rule we stated Model payments. We have modified the As we stated in the proposed rule, if our belief that it would be necessary to text of the regulation at § 512.280(c) to the requirement to apply the MIPS waive the requirement to apply the more closely align with the proposed payment adjustment factors were not MIPS payment adjustment factors under policy as described in the preamble to waived, the participant-specific section 1848(q)(6)(E) of the Act and 42 the proposed rule. If an RO participant technical episode payments made with CFR 414.1405(e) that may otherwise does not earn a positive MIPS respect to services furnished by MIPS apply to payments made for services adjustment, payments for the PC will be eligible clinicians in freestanding billed under the professional RO Model- reduced by the MACs as they would be radiation therapy centers that are billed specific HCPCS codes. outside the RO Model. under the professional RO Model- We solicited comment on our specific HCPCS codes may be increased proposal to waive the MIPS payment c. Waiver of Requirement To Include or decreased due to the MIPS payment adjustment factors. The following is a Technical Component Payments in adjustment factors. In contrast, the MIPS summary of the public comments Calculation of the APM Incentive payment adjustment factors would not received on this proposal and our Payment Amount apply to payments of claims processed response: In the proposed rule, we stated that under the OPPS, and as a result, would Comment: Many commenters we believed that it would be necessary not apply to the participant-specific disagreed with this proposal, arguing for purposes of testing the RO Model to

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exclude payments for the technical RO for the Model evaluation. Specifically, that represent the cost of equipment, Model-specific HCPCS codes (to the we believe that, without this waiver, supplies, and personnel used to perform extent they might be considered some RO participants may change their a procedure). We do not believe it payments for covered professional billing behavior by shifting the setting would be appropriate under the RO services as defined in section in which they furnish RT services from Model for payments for technical 1848(k)(3)(A) of the Act) from the HOPDs to freestanding radiation therapy services to be included in the APM ‘‘estimated aggregate payment amounts centers in order to increase the amount Incentive Payment calculation. Second, for covered professional services’’ used of participant-specific technical episode inclusion of the TC payment of the RO to calculate the APM Incentive Payment payments, producing unwarranted Model in the APM Incentive Payment amount under § 1833(z)(1)(A) of the Act increases in their APM Incentive calculation would potentially prejudice and codified at 42 CFR 414.1450(b). We Payment amount. In the proposed rule, the Model testing of site neutral specifically believe it is necessary to we discussed our belief that this would payments, since PGPs furnishing RT exclude the technical RO Model-specific prejudice the model testing of site services in HOPDs (which are paid HCPCS codes from the calculation of neutral payments as well as potentially under OPPS) would not have the TC estimated aggregate payments for interfering with the Model’s design to included in the calculation. We believe covered professional services as defined incentivize participants to preserve or that if we included the TC payment of in 42 CFR 414.1450(b)(1). The RO improve quality by tying performance to the RO Model in the APM Incentive Model HCPCS codes are split into a incentive payments if participant Payment calculation, we would create a professional component and a technical behavior is focused on maximizing the situation that may inadvertently component to reflect the two types of APM Incentive Payment. incentivize Professional participants to services provided in the Model by the For these reasons, we stated our belief change their treatment pathways so that three different RO participant types: that it would be necessary to waive the TC services are furnished in a PGPs, HOPDs, and freestanding requirements of 42 CFR 414.1450(b) to freestanding radiation therapy center radiation therapy centers, across the extent they would require inclusion instead of an HOPD in an attempt to different service sites. RO participants of the technical RO Model-specific increase the amount of services will bill the Model-specific HCPCS HCPCS codes as covered professional rendered that would count towards their codes that are relevant to their RO services when calculating the APM APM Incentive Payment. By not participant type. Incentive Payment amount. including the TC payment of the RO In the proposed rule, we discussed We solicited public comments on our Model in the APM Incentive Payment our belief that this waiver was necessary proposal to exclude the Technical calculation, we will be treating the TC because, under 42 CFR 414.1450, the Component from the APM Incentive payment the same no matter where the APM Incentive Payment amount for an Payment calculation. The following is a location the service is rendered and thus eligible clinician who is a QP is equal summary of the public comments preventing potentially prejudicing the to 5 percent of his/her prior year received on this proposal and our Model testing of site neutral payments. estimated aggregate payments for response: After considering public comments, covered professional services as defined Comment: Many commenters we are finalizing our proposal at in section 1848(k)(3)(A) of the Act. The disagreed with this proposal, stating § 512.280(d) to exclude the TC payment technical RO Model-specific HCPCS that not including the TC in the of the RO Model from the APM codes include the codes that we have payment amount used to calculate the Incentive Payment calculation, with a developed to bill the services on the APM Incentive Payment could make it modification to clarify that CMS is included RT services list that are difficult to offset any reduced payments waiving the requirements of considered ‘‘technical’’ (those that that occur as a result of RO Model § 414.1450(b) of 42 CFR chapter IV for represent the cost of the equipment, participation. Several commenters this purpose. Additionally, we would supplies and personnel used to perform stated that not including the TC in the note that we have revised our the procedure). APM Incentive Payment calculation projections regarding the number of If the requirement to include undercuts the spirit and letter of expected QPs in the RO Model to also payments for the technical RO Model- MACRA’s intent of encouraging include physicians participating in the specific HCPCS codes in the calculation clinicians to assume risk and participate RO Model who we would expect to of the APM Incentive Payment amount in APMs. These commenters stated this qualify as partial QPs under the Quality were not waived, PGPs furnishing RT was the case because a lower APM Payment Program. services in freestanding radiation Incentive Payment, resulting from therapy centers (which are paid under exclusion of the TC in the payment d. General Payment Waivers the PFS) participating in the Model will calculation, would fail to adequately In the proposed rule, we discussed have technical RT services included in compensate eligible clinicians for our belief that it is necessary for the calculation of the APM Incentive participation in the RO Model, which is purposes of testing the RO Model to Payment amount, but PGPs furnishing an Advanced APM. A few commenters waive requirements of certain sections RT services in HOPDs (which are paid suggested including a portion of the TC of the Act, specifically with regard to under OPPS) participating in the Model payment in the APM Incentive how payments are made, in order to would not have technical RT services calculation, as opposed to none of it. allow the RO Model’s prospective included in the calculation of the APM Response: We disagree with episode payment to be fully tested. Incentive Payment amount. We believe commenters’ recommendations to Therefore, we proposed to waive: these potential differences between include part or all of the TC in the • Section 1848(a)(1) of the Act that participant-specific technical episode payment amount used to calculate the requires payment for physicians’ payments processed and made under APM Incentive Payment. The reasons services to be determined under the PFS the PFS and those made under the OPPS for this policy are threefold. First, the to allow the professional and technical would be problematic for the Model test TC payment of the RO Model is, component payments for RT services to by creating potentially misaligned generally speaking, not a payment for be made as set forth in the RO Model. incentives between and among RO professional services. Rather, it is a We believe that waiving section participants, as well as other challenges payment for technical services (those 1848(a)(1) of the Act will be necessary

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because otherwise many of the RO under the OPPS ‘‘in a manner reflecting and reconsideration request process Model payment rates will be set by the the number, isotope, and radioactive specific to the RO Model in section PFS; intensity of such devices furnished, III.C.12 of this rule to review potential • Section 1833(t)(1)(A) of the Act that including separate groups for RO Model reconciliation errors. We requires payment for outpatient palladium-103 and iodine-125 devices noted in the proposed rule that, if RO department (OPD) services to be and for stranded and non-stranded participants have general Medicare determined under the OPPS to allow the devices furnished on or after July 1, claims issues they wish to appeal payments for technical component 2007.’’ (Medicare claims issues experienced by services to be paid as set forth in the RO Response: We appreciate these the RO participant that occur outside Model because otherwise the comments and agree that in order to the scope of the RO Model, but during participant-specific technical episode finalize the RO Model as proposed a their participation in the RO Model), payment will be set by the OPPS (we waiver of section 1833(t)(2)(H) is then the RO participants should note that the waiver of OPPS payment necessary. In particular, section continue to use the standard CMS will be limited to RT services under the 1833(t)(2)(H) requires separate payment claims appeals procedures under RO Model); and for devices of brachytherapy, but the RO section 1869 of the Act. • Section 1833(t)(16)(D) of the Act Model will utilize episode-based We proposed to implement this regarding payment for stereotactic payment, which means that CMS will waiver because the pricing methodology radiosurgery (a type of RT covered by make a single payment for the radiation for the RO Model is unique and as such the RO Model) to allow the payments service including for brachytherapy and we have developed a separate timely for technical component services to be any other services that were furnished error notice and reconsideration request paid as set forth in the RO Model as part of the episode. process that RO participants will use in because RO Model payment amounts Comment: A commenter stated that lieu of the claims appeals process under would be modality agnostic and CMS should not waive section section 1869 of the Act. episodic such that all treatments and 1833(t)(2)(H) of the Act, but should In section III.C.12 of the proposed rule duration of treatment for this cancer instead incorporate the requirements of (84 FR 34528 through 34529), we type are paid the same amount. that provision into the proposed RO discussed the process for RO We proposed to waive these Model by paying separately for participants to contest the calculation of requirements because these statutory brachytherapy sources outside of the RO their reconciliation payment amounts, provisions establish the current Model payment bundles using the calculation of their reconciliation Medicare FFS payment methodology. Medicare’s current system of coding and repayment amounts, and the calculation Without waiving these specific reimbursement for brachytherapy of their AQS. Reconciliation payment provisions of the Act, we would not be sources. amount means a payment made by CMS able to fully test whether the Response: We appreciate the to an RO participant as determined in prospective episode pricing comment, but disagree that we should accordance with § 512.285. This process methodology tested under the RO Model pay separately in the RO Model for would ensure that individuals involved (as discussed in section III.C.6 of this brachytherapy source payments in adjudicating these timely error final rule) was effective at reducing provided in HOPDs. One of the primary notices and reconsideration requests on program expenditures while preserving objectives for the RO Model is to test an these issues would be familiar with the or enhancing the quality of care. episode-based payment. Without payment model being implemented and Specifically, the RO Model will test waiving this provision, we would not be would ensure that these issues are whether adjusting the current fee-for- testing the RO Model as an episode- resolved in an efficient manner by service payments for RT services to a based payment model as proposed and individuals with knowledge of the prospective episode-based payment intended. payment model. model will incentivize physicians to We received no comments on the Our proposal does not limit Medicare deliver higher-value RT care. Without general payment waivers we proposed beneficiaries’ right to the claims appeals waiving the requirements of statutory and therefore are finalizing these process under section 1869. We noted, provisions that currently determine provisions without modification. in the specific circumstance wherein a payments for RT services, payment for Additionally, after considering public health care provider acts on behalf of RT services would be made using the comments, we are also finalizing an the beneficiary in a claims appeal, current FFS payment methodology and additional waiver of section section 1869 applies. not the pricing methodology we are 1833(t)(2)(H) of the Act as some We solicited public comments on the testing through the Model. commenters have suggested. This waiver of appeal requirements. The We solicited public comments on the provision requires separate payment of following is a summary of the public general payment waivers. The following brachytherapy sources provided in comments received on this proposal and is a summary of the public comments HOPDs. As we are testing new payment our response: received on this proposal and our methodologies for RT services including Comment: A commenter supported response: brachytherapy sources provided in the fact that our proposal does not limit Comment: Some commenters stated HOPDs, we believe that it is necessary Medicare beneficiaries’ right to the that CMS will not be able to fully test to waive this provision of the Act. claims appeals process under section the RO Model as proposed unless CMS 1869. The commenter believed it is e. Waiver of Appeals Requirements also waives section 1833(t)(2)(H) of the imperative that RO beneficiaries have Act, which provides that ‘‘with respect In the proposed rule, we discussed the same rights as other Medicare to devices of brachytherapy consisting our belief that it was necessary for beneficiaries to appeal coverage of a seed or seeds (or radioactive purposes of testing the RO Model to decisions they believe to be unfounded. source), the Secretary shall create waive section 1869 of the Act specific Response: We appreciate the additional groups of covered [outpatient to claims appeals to the extent commenter’s support. department services] that classify such otherwise applicable. We proposed to After considering public comments, devices separately from the other implement this waiver so that RO we are finalizing, without modification, services (or group of services)’’ paid participants may utilize the timely error our proposed waiver of appeals

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requirements, specifically to waive discussed our belief that this waiver was section III.C.6.g of this final rule, we section 1869 of the Act specific to necessary to allow for consistent model will reduce the incorrect payment claims appeals for RO Model claims. evaluation and ensure site neutrality in withhold from 2 percent to 1 percent RO Model payments, which is a key and not begin the quality withhold until f. Waiver of Amendments Made by feature of the RO Model. PY1. The patient experience withhold Section 603 of the Bipartisan Budget Act We solicited public comments on will not begin until PY3. If of 2015 payment waivers. We received no reconciliation were to be conducted In the proposed rule, we discussed comments on this policy and are every six months, this would require RO our belief that it was necessary for finalizing it as proposed. participants to submit quality measure purposes of testing the RO Model to data more frequently, which would waive application of the PFS relativity 11. Reconciliation Process increase provider burden. adjuster which applies to payments We proposed that we would conduct We would like to clarify that we are under the PFS for ‘‘non-excepted’’ items an annual reconciliation for each RO adding a definition at § 512.205 for and services identified by section 603 of participant after each PY to reconcile ‘‘initial reconciliation,’’ which means the Bipartisan Budget Act of 2015 (Pub. payments owed to the RO participant the first reconciliation of a PY that L. 114–74), which amended section with payments owed to CMS due to the occurs as early as August following the 1833(t)(1)(B)(v) of the Act and added withhold policies discussed in section applicable PY. We also are finalizing the paragraph (t) (21) to the Social Security III.C.6.g of the proposed rule (84 FR definition of ‘‘true-up reconciliation’’ at Act. Sections 1833(t)(1)(B)(v) and (t) (21) 34527). We proposed that this annual § 512.205 to mean the process to of the Act exclude certain items and reconciliation would occur in the calculate additional reconciliation services furnished by certain off-campus August following a PY in order to allow payments or repayment amounts for provider-based departments (non- time for claims run-out, data collection, incomplete episodes and duplicate RT excepted off-campus provider-based reporting, and calculating results.78 services that are identified after the departments (PBDs)) from the definition In the example we provided in the initial reconciliation and after a 12- of covered outpatient department proposed rule, the annual reconciliation month claims run out for all RO services for purposes of OPPS payment, for PY1 would apply to episodes episodes initiated in the applicable PY. and direct payment for those services to initiated January 1, 2020 (or April 1, We also would like to clarify that the be made ‘‘under the applicable payment 2020) through December 31, 2020, and true-up reconciliation process is only system’’ beginning January 1, 2017. We the annual reconciliation for PY1 would related to the incorrect payment established the PFS as the ‘‘applicable occur in August of 2021. We stated that withhold, and we will not conduct a payment system’’ for most non-excepted an annual reconciliation is appropriate true-up reconciliation for the quality items and services furnished in non- because incomplete episodes and withhold or the patient experience excepted off-campus PBDs (81 FR duplicate RT services as described in withhold. 79699) and, in order to facilitate section III.C.6.a of the proposed rule and Moreover, an additional payment under the PFS, we apply a PFS this final rule may result in additional reconciliation, if done a few months relativity adjuster that is currently set at payment owed to an RO participant or prior to what we call the initial 40 percent of the OPPS rate (82 FR owed to CMS for RT services furnished reconciliation before allowing for a 53027). We also require OPDs to use the to an RO beneficiary in those cases. reasonable claim run-out, would be modifier ‘‘PN’’ on applicable OPPS The following is a summary of the based on incomplete data. We believe claim lines to identify non-excepted comments we received on the proposal this would unduly complicate the items and services furnished in non- for the annual reconciliation to occur in reconciliation process. In the case of an excepted off-campus PBDs. The August following a PY and our initial reconciliation, CMS calculations modifier triggers application of the PFS responses to these comments: will use claims data available at that relativity adjuster in CMS’ claims Comment: Many commenters time for claims run-out and expect to processing systems. expressed concern about the annual provide RO participants with a Under the RO Model, we proposed to reconciliation taking place in August of reconciliation report in August of the waive requirements under section the following PY, citing issues of health subsequent year following the 1833(t)(1)(B)(v) and (t)(21) of the Act for care provider burden, financial applicable PY. With respect to the all RO Model-specific payments to hardship, and patient access to care. A concerns about patient access to care, applicable OPDs. If a non-excepted off- commenter requested that CMS the commenter did not explain how the campus PBD were to participate in the prospectively reimburse RO participants timing of reconciliation in a mandatory RO Model, it would be required to for their payment withholds to ensure model would affect patient access to submit RO Model claims consistent that they do not have a gap in revenue. care. We do not expect that with our professional and technical Another commenter recommended that reconciliation timing will have any billing proposals in section III.C.7. In reconciliation should be conducted impact on patient access to care. With addition, we proposed to not apply the every six months. Another commenter respect to the commenter who requested PFS relativity adjuster to the RO Model suggested that the RO Model implement that CMS prospectively reimburse RO payment and instead pay these a reconciliation to occur immediately participants for their payment participants in the same manner as following the performance year with a withholds, we understand the other RO participants because the RO final reconciliation to account for claims commenter to be requesting that CMS Model pricing methodology’s design as runout. eliminate the payment withhold. We discussed in section III.C.6.c of this final Response: Changes made elsewhere in decline to do so because the withhold rule sets site-neutral national base rates, this final rule reduce the financial reserves money for purposes of and adding the PFS relativity adjuster to burden associated with the timing of reconciling duplicate RT services and the RO Model payment for RO reconciliations. Specifically, as noted in incomplete episodes, which protects the participants that are non-excepted off- financial integrity of the model and campus PBDs would disrupt this 78 Claims run-out is the period of time that CMS reduces any immediate negative approach and introduce a payment allows for the timely submission of claims by financial impact on RO participants due differential. In the proposed rule, we providers and suppliers before reconciliation. to reconciliation. As a result of the stop-

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loss policy described in section succession. We proposed to follow the been revised to replace the term III.C.6.e(4) we are finalizing this same process for each subsequent ‘‘payments or repayments’’ with the provision with modification to add a performance year. Under our proposal, defined terms ‘‘reconciliation stop-loss reconciliation amount to the we would conduct a true-up of PY1 in payments’’ and ‘‘repayment amounts.’’ reconciliation process, as codified at August 2022, a true-up of PY2 in August In addition, we have replaced the § 512.285(f). We would like to clarify 2023, and so forth. phrase ‘‘that are identified after claims that we are adding a definition at We solicited public comments on our run-out’’ with the more precise ‘‘that are § 512.205 for ‘‘stop-loss reconciliation,’’ proposal for a true-up process. The identified after initial reconciliation’’ which means the amount owed to RO following is a summary of the comment and included the time frame for claims participants that have fewer than 60 we received on our proposal and our run-out. episodes during 2016–2018 for the loss response to the comment: incurred under the Model and were Comment: A commenter b. Reconciliation Amount Calculation furnishing included RT services at recommended eliminating the true-up To calculate a reconciliation payment November 30, 2020 in the CBSAs process to streamline the reconciliation amount either owed to an RO selected for participation as described in process. participant by CMS or a reconciliation § 512.285(f). Response: We thank this commenter repayment amount owed to CMS by an We have also modified the text of the for the suggestion. We believe that the RO participant, we proposed to use the regulation at § 512.285 to describe how true-up process requires little effort on following process: reconciliation payments and repayment the part of RO participants and that it • Calculate the incorrect episode amounts are calculated and what details is necessary to properly account for payment amount. We proposed to sum are provided in the reconciliation report additional reconciliation payments or all money the RO participant owes CMS as described in the preamble to the repayment amounts for incomplete due to incomplete episodes and proposed rule. We have made a number episodes and duplicate RT services that duplicate services, and subtract the of non-substantive editorial and are identified after a full 12-month amount from the incorrect payment organizational changes to streamline claims run-out. Eliminating the true-up withhold amount (that is, the and improve the clarity of the regulation process could lead to a gaming cumulative withhold of 2 percent on text at § 512.285. We note that the opportunity where RO participants episode payment amounts for all RO proposed rule indicated that might wait to submit claims until after episodes furnished during that PY by reconciliation would occur annually in the claims run-out period used in the that RO participant).79 This would August. Although this final rule first reconciliation for a PY. The net determine the amount owed to the RO provides that reconciliation will occur reconciliation payment or repayment participant by CMS based on total annually, we are removing the language amount owed for the PY is the sum of payments made to the RO participant indicating that reconciliation will (h)(1) and (f)(2) in the reconciliation for incomplete episodes and duplicate always occur in August, and instead example provided in section III.C.11.b. RT services for a given PY, if applicable. We are finalizing this provision state that initial reconciliation could An RO participant would receive the concerning the true-up process with occur as early as August, because we full incorrect payment withhold amount modification to codify the true-up may require additional flexibility if it had no duplicate RT services or process at § 512.285(g). We note that in depending on the availability of data incomplete episodes (as explained in the proposed rule we provided and other considerations. If the RO section III.C.6.g). In instances where examples of the timing of the PY1 and participant fails to timely pay the full there are duplicate RT services or PY2 true-ups. Given the change in the repayment amount, CMS will recoup incomplete episodes, the RO participant Model performance period, we are the repayment amount from any would owe a repayment amount to CMS clarifying that we will conduct the PY1 payments otherwise owed by CMS to if the amount of all duplicate RT the RO participant, including Medicare true-up reconciliation as early as August 2023, and the PY2 true-up services and incomplete episodes payments for items and services exceeds the incorrect payment withhold unrelated to the RO Model, and interest reconciliation as early as August 2024, and so forth. While we have every amount. will be charged in accordance with 42 • For Professional participants during CFR 405.378. expectation that all reconciliations and true-up reconciliations will occur in the Model’s performance period: We a. True-Up Process August, we recognize that in proposed that if the RO participant is a We proposed that we would conduct exceptional circumstances, there could Professional participant, then we would an annual true-up of reconciliation for be a modest delay in performing such add the Professional participant’s each PY. We proposed to define the reconciliations. For this reason, we are incorrect episode payment amount to term ‘‘true-up’’ as the process to revising the regulation text at the quality reconciliation amount. The calculate additional payments or § 512.285(a) to remove reference to quality reconciliation amount would be repayments for incomplete episodes and conducting annual reconciliations ‘‘in determined by multiplying the duplicate RT services that are identified August.’’ participant’s AQS (as a percentage) after claims run-out. More specifically, We are finalizing our definition of against the total two-percentage point we proposed that we would true-up the ‘‘true-up’’ with technical modifications maximum amount as described in PY1 reconciliation approximately one to read as follows: ‘‘True-up section III.C.8.f(2). • year after the initial reconciliation reconciliation means the process to For Technical participants in PY1 results were calculated. This would calculate additional reconciliation and PY2: We proposed that if the RO align the PY2 reconciliation of the payments or repayment amounts for participant is a Technical participant following year with the PY1 true-up, incomplete episodes and duplicate RT then the Technical participant’s thereby allowing for a full claims run- services that are identified after the reconciliation amount would be equal to out on PY1, and reducing any potential initial reconciliation and after a 12- 79 Please note that the final rule reduced the confusion for RO participants that may month claims run-out for all RO incorrect payment withhold amount from the be caused by receiving multiple episodes initiated in the applicable PY.’’ proposed 2 percent to 1 percent, discussed in reconciliation reports in close Specifically, the proposed definition has section III.C.6.g of this final rule.

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the incorrect episode payment amount. CMS $3,000 for duplicate payments due Comment: A commenter requested There would be no further additions or to claims submitted on behalf of that detailed information be provided subtractions. beneficiaries who received RT services on reconciliation reports so that RO • For Technical participants in PY3, by another RT provider or RT supplier participants could attribute data by PY4, and PY5: We proposed to add the during their RO episode. Lastly, the clinician and category. Technical participant’s incorrect Professional participant would owe Response: We thank the commenter episode payment amount to the patient CMS $1,500 for cases of incomplete for this suggestion and we will take this experience reconciliation amount, in episodes whereby the PC of the RO into consideration as we design the section III.C.6.g(3). Technical episode was billed and due to death or reconciliation reports. participants and Dual participants could other reason, the TC was not billed by After considering public comments on earn up to the full amount of the patient the time of reconciliation. In the section III.C.11 of the proposed rule, we experience withhold (1 percent of the example in the proposed rule, the are finalizing our proposed provisions at technical episode payment amounts) for payments for duplicate RT services and § 512.285 that the reconciliation process a given performance year based on their incomplete episodes would be will occur annually, with each RO results from the patient-reported subtracted from the incorrect payment participant receiving a reconciliation ® CAHPS Cancer Care Radiation Therapy withhold amount to render $1,500 due report that indicates the reconciliation Survey. to the RO participant from CMS for the payment amount they are due or the • For Dual participants in PY1 and incorrect episode payment amount (a). repayment amount owed to CMS. Please PY2: We proposed to add the Dual This amount would then be added to note that because of the change to the participant’s incorrect episode payment the quality reconciliation amount (b). incorrect payment withhold in this final amount to the quality reconciliation The quality withhold amount for this rule, described in section III.C.11 of this amount. The quality reconciliation RO participant would be $6,000 or 2 rule, we have provided an updated amount would be determined by percent of $300,000. This RO example reconciliation calculation for a multiplying the Dual participant’s AQS participant’s performance on the AQS Professional participant in Table 14, (in percentage terms) against the total would entitle them to 85 percent of the which reflects that change. The numbers two-percentage point maximum quality withhold, and, therefore, when listed in the table are illustrative only. withhold amount as described in the quality reconciliation amount (b) is In this example, the total incorrect section III.C.8.f(2). added to the incorrect payment payment withhold amount for this • For Dual participants in PY3, PY4, withhold amount (a), and a total Professional participant is $3,000 or 1 and PY5: We proposed to add the Dual reconciliation payment of $6,600 (c) is percent of $300,000 (the total payment participant’s incorrect episode payment due to the RO participant from CMS for amounts for the RO episodes initiated in amount to the quality reconciliation the PY for this RO participant after the that performance year. We note that the amount. The quality reconciliation trend factor, adjustments, and discount example in the proposed rule does not amount would be determined by factor have been applied). The include the geographic adjustment or multiplying the participant’s AQS (in Professional participant owes CMS the 2 percent adjustment for percentage terms) against the total two- $3,000 for duplicate RT services due to sequestration. percentage point maximum withhold claims submitted on behalf of RO amount as described in section We solicited public comment on our beneficiaries who received any included III.C.8.f(2). Then, we would add the proposal on calculating reconciliation RT services (duplicate RT services) from Dual participant’s patient experience amounts. The following is a summary of another RT provider or RT supplier reconciliation amount to this total. the comments we received on our during their RO episode. Lastly, in this The geographic adjustment and the 2 proposal and our responses to these example, the Professional participant percent adjustment for sequestration comments: owes CMS $1,500 for cases of would be applied to the incorrect Comment: A commenter requested incomplete episodes where the PC of payment withhold, quality withhold, clarification as to how beneficiary the RO episode was billed, and due to and patient experience withhold coinsurance would be accounted for in death or another reason, the TC was not amounts during the reconciliation reconciliation and repayment amounts, billed by the time of reconciliation and process. Beneficiary coinsurance would stating that there are conflicting for cases of incomplete episodes where be waived for the reconciliation interpretations of ‘‘waiving’’ beneficiary the RO beneficiary switched RT payment and repayment amounts, coinsurance. provider or RT supplier before all the meaning that the RO participant may Response: To clarify, we are waiving included RT services in the RO episode not collect 20 percent of what is owed the beneficiary coinsurance obligation had been furnished. In this example, the to CMS from the RO beneficiary, and when an RO participant owes CMS payments for duplicate RT services and CMS will not collect 20 percent of what money (repayment amount) or CMS incomplete episodes would be it owes the RO participant from the RO owes the RO participant money subtracted from the incorrect payment beneficiary. (reconciliation payment). Thus, no withhold amount to render $1,500 due We provided an example beneficiary coinsurance will be to CMS from the RO participant for the reconciliation calculation for a collected on these amounts. We have incorrect episode payment amount (a). Professional participant in Table 10 of clarified our regulation text on this issue This amount is then added to the the proposed rule. The numbers listed at § 512.285(i)(3). We will provide RO quality reconciliation amount (b). The in that table are illustrative only. In the participants with additional instructions quality withhold amount for this example in the proposed rule, the for billing, particularly as it pertains to participant is $6,000 or 2 percent of incorrect payment withhold amount for how beneficiary coinsurance will be $300,000. This RO participant’s the Professional participant would be accounted for in reconciliation. performance on the AQS entitles him or $6,000 or 2 percent of $300,000 (the Additional instructions will be made her to 85 percent of the quality total payments for the participant after available through the Medicare Learning withhold, and, therefore, when the the trend factor, adjustments, and Network (MLN Matters) publications, quality reconciliation amount (b) is discount factor have been applied). The model-specific webinars, and the RO added to the incorrect payment Professional participant would owe Model website. withhold amount (a), and a total

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reconciliation payment of $3,600 (d) is at $200, and no SOE for the TC was services, the RO participant that due to the RO participant from CMS for billed within 28 days, then the RO initiated the PC or TC is owed the that performance year. We note that in participant’s repayment amount would bundled payment less the FFS amount this example the RO participant did not be $1,800 for this RO episode, and this for the RT services furnished by the RT qualify to receive a stop-loss would be accounted for during provider or RT supplier that did not reconciliation amount (c) as codified at reconciliation. Also, for any incomplete initiate the PC or TC. The other RT § 512.285(f) and, therefore, no value is episode that is reconciled to FFS provider or RT supplier that furnished listed. We note that this example does amounts because the RO beneficiary RT services to that beneficiary, whether not include the geographic adjustment switches RT provider or RT supplier an RO participant or not, will be paid or the 2 percent adjustment for before all RT services in the RO episode FFS for those RT services. The FFS sequestration. have been furnished, the RO beneficiary amount to be subtracted from the We are finalizing the reconciliation owes the RO participant(s) that initiated bundled payment of the RO participant process at § 512.285 as proposed with the PC or TC 20 percent of the FFS that initiated the PC or TC of that RO the following clarification: CMS uses amount for the RT services that were episode, however, cannot exceed the the reconciliation process to identify furnished during that RO episode, not participant-specific professional episode any reconciliation payment owed to an 20 percent of the episode bundled payment amount or the participant- RO participant or any repayment payment (see section III.C.6.i of this specific technical episode payment amount owed by an RO participant to final rule). For any RO episode that amount that the RO participant received CMS. For instance, in the case where involves one or more duplicate RT for the RO episode. If the FFS amount the SOE for the PC is billed, yet the SOE services, the payment for the RO to be subtracted for duplicate RT for the TC is not billed, CMS will owe participant that initiated the PC or TC services exceeds the participant-specific the RO participant only the FFS amount will be reconciled by reducing the RO professional episode payment amount for the RT services included in the PC participant’s episode payment by the or the participant-specific technical that was billed by the RO participant for FFS amount of the duplicate RT services episode payment amount, CMS will not that RO beneficiary. If, in this case, the furnished by the RT provider or RT subtract more than the participant- RO participant was paid $2,000 for the supplier that did not initiate the PC or specific professional episode payment first episode payment of the PC and TC. amount or participant-specific technical only furnished one planning service, This means that for any RO episode episode payment amount received by which under FFS would be reimbursed that involves one or more duplicate RT the RO participant.

12. Timely Error Notice and suspected errors in the calculation of been deemed final. Therefore, we Reconsideration Request Processes their reconciliation payment amount or proposed a policy that would permit RO In the proposed rule, we stated that repayment amount (in section III.C.11 of participants to contest errors found in we believed it would be necessary to the proposed rule and this final rule), or the RO reconciliation report, but not the implement timely error notice and AQS (in section III.C.8.f of the proposed RO Model pricing methodology or AQS reconsideration request processes under rule and this final rule) as reflected on methodology. We note that, if RO which RO participants may dispute an RO reconciliation report that has not participants have Medicare FFS claims

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or decisions they wish to appeal (that is, of the settlement report for their review, 45-day period for participants to review Medicare FFS issues experienced by the allowing them to dispute suspected and submit a timely error notice. RO participant that occur outside the calculation errors in that report before Response: We agree with commenters scope of the RO Model but during their the payment determination is deemed that providing additional time may participation in the RO Model), then the final. Other models currently being benefit some RO participants in RO participants should continue to use tested by the Innovation Center make identifying and understanding the standard CMS procedures through model-specific payments in response to calculation errors. We would note that their Medicare Administrative claims or on the basis of model increasing the timeline to 45 days, as a Contractor. beneficiary attribution that are similarly commenter suggested, would align our Section 1869 of the Act provides for subject to a model-specific process for processes with those used in the CJR a process for Medicare beneficiaries, resolving disputes. In some models providers, and suppliers to appeal model. We want to reiterate that we are currently being tested by the Innovation committed to paying RO participants certain claims decisions made by CMS. Center, these reconsideration processes However, we proposed that we would accurately and correctly and believe that involve two levels of review. the calculation error process serves an waive the requirements of section 1869 Building off of these existing of the Act specific to claims appeals as important function in achieving that processes, we proposed for the first goal. The procedures for processing and necessary solely for purposes of testing level of the reconsideration process to the RO Model. Specifically, we believe issuing reconciliation payment amounts be a timely error notice. Specifically, RO and repayment amounts that we are it would be necessary to establish a participants could provide written means for RO participants to dispute finalizing in section III.C.11 of this final notice to CMS of a suspected error in rule require specific timeframes in order suspected errors in the calculation of the calculation of their reconciliation their reconciliation payment amount, to process these payments properly and payment amount, repayment amount, or promptly. As such we believe the need repayment amount, or AQS. Having RO AQS for which a determination has not for extending the deadline for participants utilize the standard claims yet been deemed to be final under the submission of notices of calculation appeals process under section 1869 of terms of this part. As proposed, the RO error should be balanced with our goal the Act to appeal the calculation of their participant would have 30 days from the to issue reconciliation payment amounts reconciliation payment amount, date the RO reconciliation report is and repayment amounts promptly. repayment amount, or AQS would not issued to provide their timely error Therefore, to address the commenters’ lead to timely resolution of disputes notice (see § 512.290). This would be concerns while balancing our need to because MACs and other CMS officials subject to the limitations on finalize payment determinations would not have access to beneficiary administrative and judicial review as promptly, this final rule provides that a attribution data, and the standard claims previously described in section II.K. appeals process hierarchy would not notice of calculation error must be Specifically, an RO participant could engage the Innovation Center and its not use the timely error notice process received by CMS within 45 days after contractors until late in the process. to dispute a determination that is the issuance of a reconciliation report. Accordingly, we proposed a two-level precluded from administrative and After considering public comments, process for RO participants to request judicial review under section we are finalizing our proposed timely reconsideration of determinations 1115A(d)(2) of the Act and § 512.170. error notice provisions with a related to calculation of their We proposed that this written notice modification of extending the amount of reconciliation payment, repayment must be submitted in a form and time that RO participants have to submit amount, or AQS under the RO Model. manner specified by CMS. Unless the their timely error notice, which must be The first level would be a timely error received by CMS within 45 days after notice process and the second level to RO participant provides such notice, the the issuance of a reconciliation report, be reconsideration review process, as RO participant’s reconciliation payment at § 512.290(a). Additionally, we are subsequently discussed. The processes amount, repayment amount, or AQS here are based on the processes would be deemed final after 30 days, modifying the regulatory text at implemented under certain models and CMS would proceed with payment § 512.290(a) to align the regulatory text currently being tested by the Innovation or repayment, as applicable. If CMS with the proposal discussed in the Center. receives a timely notice of an error, we preamble of the proposed rule that As proposed, only RO participants would respond in writing within 30 would permit RO participants to contest may utilize the first and second level of days to either confirm that there was a errors found in the RO reconciliation the reconsideration process, unless calculation error or to verify that the report, but not the RO Model pricing otherwise stated in other sections of this calculation is correct. CMS would methodology or AQS methodology. We subpart. We believe that only RO reserve the right to an extension upon are removing proposed § 512.290(a)(4), participants should be able to utilize the written notice to the RO participant. We which stated that an RO participant process because non-participants would proposed to codify this timely error must have submitted a timely error not receive calculation of a notice policy at § 512.290(a). notice on an issue not precluded from reconciliation payment amount, We solicited comment on this administrative or judicial review as a repayment amount, or AQS, and would proposal. The following is a summary of condition of using the reconsideration generally have access to the section the public comments received on this review process described in 1869 claims appeals processes to appeal proposal and our response: § 512.290(b). That provision is the payments they receive under the Comment: Two commenters requested unnecessary because § 512.290(b) Medicare program. additional time to review reconciliation specifies that the reconsideration reports and submit potential errors to process may be invoked only to contest 1. Timely Error Notice CMS. A commenter suggested extending CMS’ response to a timely error notice. As we explained in the proposed rule, the timeline to a 90-day period for Finally, we have made technical in some models currently being tested participants to review and submit a changes in § 512.290(a) to refer to the by the Innovation Center, CMS provides timely error notice. Another commenter timely error notice in a consistent model participants with a courtesy copy suggested extending the timeline to a manner.

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2. Reconsideration Review As proposed, the reconsideration consistent with the timelines around We also proposed a second level of review would be an on-the-record timely error and reconsideration the reconsideration process that would review (a review of the memoranda or requests in the CJR Model. permit RO participants to dispute CMS’ briefs and evidence only) conducted by We are committed to paying RO response to the RO participant’s a CMS reconsideration official. The participants accurately and correctly and believe that the timely error and identification of errors in the timely CMS reconsideration official would reconsideration review processes as error notice, by requesting a make reasonable efforts to notify the RO proposed serve an important function in reconsideration review by a CMS participant and CMS in writing within achieving that goal. The procedures for reconsideration official. As is the case 15 days of receiving the RO participant’s processing and issuing reconciliation for many models currently being tested reconsideration review request of the payment amounts and repayment by the Innovation Center, we proposed following: The issues in dispute, the amounts that we are finalizing in that the CMS reconsideration official briefing schedule, and the review procedures. The briefing schedule and section III.C.11 of this final rule require will be a designee of CMS who is review procedures would lay out the specific timeframes in order to process authorized to receive such requests who timing for the RO participant and CMS these payments properly and promptly. was not involved in the responding to to submit their position papers and any Similar processes have been developed the RO participant’s timely error notice. other documents in support of their and are utilized in other CMS models. To be considered, we proposed that the position papers; the review procedures As such we believe the need for reconsideration review request must be would lay out the procedures the extending the deadline for submission submitted to CMS within 10 days of the reconsideration official will utilize of reconsideration review requests issue date of CMS’ written response to when reviewing the reconsideration should be balanced with our goal to the timely error notice. The review request. In the proposed rule, we issue reconciliation payment amounts reconsideration review request would proposed that the CMS reconsideration and repayment amounts promptly. be submitted in a form and manner official would make all reasonable Comment: A commenter suggested specified by CMS. efforts to complete the on-the-record that CMS should be held to a similarly As there will not otherwise be a review of all the documents submitted strict time standard for the timely error notice response for the by the RO participant and issue a reconsideration review process as the reconsideration official to review, in written determination within 60 days RO participant is. They further suggest order to access the reconsideration after the submission of the final position that CMS should be strictly bound to a review process, we proposed that an RO paper in accordance with the timeline, and not have the flexibility participant must have timely submitted reconsideration official’s briefing allowed by making all reasonable efforts a timely error notice to CMS in the form schedule. As this would be the final to respond to the reconsideration review and manner specified by CMS, and this step of the Innovation Center within 60 days of receipt of the final timely error notice must not have been administrative dispute resolution position paper. The commenter believes precluded from administrative and process, we proposed that the CMS and the RO participant should be judicial review. Specifically, where the determination made by the CMS given the same amount of time during RO participant does not timely submit reconsideration official would be their portions of the reconsideration a timely error notice with respect to a binding and not subject to further review, and if CMS goes over that time particular reconciliation payment review. This reconsideration review limit, the RO participant’s position amount, reconciliation repayment process is consistent with other should be accepted and the final amount, or AQS, we proposed that the resolution processes used throughout payment amount, repayment amount, or reconsideration review process would the agency. We proposed to codify this AQS should reflect that. not be available to the RO participant reconsideration review process at Response: We appreciate the with respect to the RO participant’s § 512.290(b). commenter’s suggestion that we must reconciliation payment amount, the We solicited public comment on our also adhere to a time standard when calculation of the RO participant’s provisions regarding the reconsideration responding to the RO participant during repayment amount, or the calculation of review process. The following is a the reconsideration review process. We the RO participant’s AQS. summary of the public comments would reiterate that we are committed In the proposed rule, we explained received on this proposal and our to paying RO participants accurately that if the RO participant did timely responses to these comments: and correctly, and we believe that the submit a timely error notice and the RO Comment: A few commenters timely error and reconsideration review participant is dissatisfied with CMS’ requested additional time for RO processes as proposed serve an response to the timely error notice, the participants to submit a reconsideration important function in achieving that RO participant would be permitted to request. goal. We note that the proposed timeline request reconsideration review by a Response: We appreciate these and the flexibility proposed for our final CMS reconsideration review official. To comments and are sympathetic to the decision on the reconsideration review be considered, we proposed that the requests from commenters for more time aligns with the timelines being utilized reconsideration review request must be for RO participants during the in other models being tested by the submitted within 10 days of the date of reconsideration review process, Innovation Center. As such, we believe CMS’s response to the timely error however we believe our modification to the timeline as proposed is appropriate, notice and must provide a detailed the timeline of the timely error notice and we will commit to sticking to the explanation of the basis for the dispute, deadline allows RO participants more timeline as proposed unless it is wholly including supporting documentation for time to contemplate their error notice unreasonable for the CMS the RO participant’s assertion that CMS because we have given them more time reconsideration official to fully review or its representatives did not accurately to flesh out the issues before submitting and decide upon the issue in the time calculate the reconciliation payment a timely error notice. Further, with the given. amount, repayment amount, or AQS in extended timeline for submission of After considering public comments, accordance with the terms of the RO timely error notices and the 10-day we are finalizing our proposed Model. deadline for reconsideration requests is reconsideration review provisions with

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non-substantive editorial and RO participants and their downstream text with the proposals discussed in the organizational changes to streamline recipients for care redesign and other preamble. These modifications and improve the clarity of the regulation forms of quality improvement as well as specifically add ‘‘patient-identifiable text at § 512.290(b). care coordination purposes. derivative data’’ to the regulatory text. The following is a summary of the Although this language was included in 13. Data Sharing public comments received on this the proposed rule’s preamble text, it was CMS has experience with a range of proposal and our responses to the inadvertently left out of the regulatory efforts designed to improve care comments: text. coordination and the quality of care, Comment: A commenter expressed and decrease the cost of care for concern that the use of third party b. RO Participant Public Release of beneficiaries, including models tested companies to collect and analyze data Patient De-Identified Information under section 1115A, most of which on the RO participants’ behalf will We did not propose to restrict RO make certain types of data available cause additional burdens on RO participants’ ability to publicly release upon request to model participants. participants to ensure that no HIPAA patient de-identified information that Based on the design elements of each requirements or agreement terms and references the RO participant’s model, the Innovation Center may offer conditions violations occur with the participation in the RO Model. In the participants the opportunity to request handling of patient-identifiable data by proposed rule, we stated our belief that different types of data, so that they can multiple parties. such information could potentially be redesign their care pathways to preserve Response: The requirement that RO included in press releases, journal or improve quality and coordinate care participants contractually bind their articles, research articles, descriptive for model beneficiaries. Furthermore, as downstream recipients in writing to articles, external reports, and statistical/ described in sections II.E and II.G of this comply with applicable law and the analytical materials describing the RO final rule, we believe it is necessary for program requirements in the RO participant’s participation and patient the Innovation Center to require certain participants’ agreements with CMS is results in the RO Model if such data to be reported by model necessary to protect the individually information has been de-identified in participants to CMS in order to evaluate identifiable health information data. accordance with HIPAA requirements in and monitor the model, including the Furthermore, in the case of covered 45 CFR 164.514(b) (84 FR 34530). Those model participant’s participation in the entities and their business associates, requirements define the data elements model, which could then also be used the privacy and security requirements that would need to be removed to to inform the public and other model promulgated under HIPAA, as modified, qualify as de-identified under that participants regarding the impact of the and HITECH would have applied to regulatory scheme. However, in order to model on both program spending and such parties regardless of what these ensure external stakeholders understand the quality of care. program regulations provide—we that information the RO participant merely highlighted the applicability of releases represents their own content a. Data Privacy Compliance these and other legal mandates. and opinions, and does not reflect the In § 512.275(a), we proposed that as a Therefore, in light of our program input or opinions of CMS, we proposed condition of their receipt of patient- interests and the various already to require the RO participant to include identifiable data from CMS for purposes applicable laws, we are finalizing this a disclaimer on the first page of any of the RO Model, RO participants would policy with references to the existing such publicly released document, the be required to comply with all privacy and security requirements content of which materially and applicable laws pertaining to any under HIPAA, as modified, and substantially references or relies upon patient-identifiable data requested from HITECH. the RO participant’s participation in the CMS under the terms of the RO Model Comment: A commenter RO Model. We proposed to codify such and the terms of any other written recommended that CMS add an a disclaimer at § 512.120(c)(2) agreement entered into by the RO additional requirement to this Model (providing ‘‘The statements contained in participant and CMS as a condition of such that data related to cancer staging this document are solely those of the the RO participant receiving such data information be stored as discrete data in authors and do not necessarily reflect (84 FR 34530). Such laws could include, the EHR or specialty-focused health IT the views or policies of the Centers for without limitation, the privacy and record, and made available to external Medicare & Medicaid Services (CMS). security standards promulgated under systems through a FHIR® (Fast The authors assume responsibility for the Health Insurance Portability and Healthcare Interoperability Resources)- the accuracy and completeness of the Accountability Act of 1996 (HIPAA), as based application programming information contained in this modified, and the Health Information interface. document.’’) We proposed to require the Technology for Economic and Clinical Response: We appreciate this use of this disclaimer so that the public, Health Act (HITECH). Additionally, we commenter’s suggestion. We believe that and RO beneficiaries in particular, are proposed to require RO participants the requirement that RO participants not misled into believing that RO contractually bind all downstream comply with all applicable laws relating participants are speaking on behalf of recipients of CMS data to the same to patient-identifiable data is sufficient the agency. terms and conditions to which the RO and that adding additional requirements The following is a summary of the participant was itself bound in its as suggested by the commenter at this public comment received on this agreements with CMS as a condition of time may present a logical outgrowth proposal and our response to the the downstream recipient’s receipt of problem as well as a burden for the RO comment: the data from the RO participant. As we participants. However, we will take this Comment: We received a comment noted in the proposed rule, binding RO recommendation under consideration supporting our proposal to require RO participants and their downstream for future rulemaking. participants to include a disclaimer on recipients to such written requirements After considering public comments, all descriptive model materials and was necessary if CMS was to protect the we are finalizing the provisions at activities. individually identifiable health § 512.275(a), with modifications to the Response: We thank you for your information data that it be shared with regulatory text to align the regulatory support.

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After considering the public comment allowing for a phase-in/transition period proprietary information and note that received on this proposal, we are so that all RO Participants could prepare we will handle the data in accordance finalizing this proposal without and complete the RO Model review with applicable laws, including but not modification at § 512.275(b). process. This commenter further limited to FOIA. In light of these requested that accreditation be used in commenters’ concerns, we are c. Data Submitted by RO Participants lieu of the monitoring requirements. modifying the proposal such that if In addition to the quality measures Response: We agree with the additional administrative data is and clinical data discussed in section commenters that accreditation by requested, the RO participants’ III.C.8 of the proposed rule (84 FR 34514 nationally recognized organizations, submission of such administrative data through 34522) and this final rule, we such as the ACR, ACRO, and ASTRO, will be optional. proposed that RO participants supply may be an indicator of the overall After considering public comments, and/or confirm a limited amount of quality of care provided by a RT we are finalizing this proposal with summary information to CMS. This provider or RT supplier. As noted modification. Requests by CMS for information includes the RO earlier in this final rule, the Model must administrative data related to the cost of participant’s TIN in the case of a include a set of quality measures to providing care, frequency of equipment freestanding radiation therapy center qualify as a MIPS APM and an use, EHR vendors, and accreditation and PGP, or CCN in the case of an Advanced APM, and as such, status will be optional for RO HOPD. We proposed to require RO accreditation is not able to replace the participants. participants supply and/or confirm the RO quality measures without d. Data Provided to RO Participants NPIs for the physicians who bill for RT compromising the Model’s qualification services using the applicable TINs. In as a MIPS APM and Advanced APM. In Thirty (30) days prior to the start of the proposed rule, we also proposed addition, we do not believe that each PY, we proposed to provide RO that RO participants may be required to accreditation provides a full picture of participants with updated participant- provide information on the number of quality care delivery in radiation specific professional episode payment Medicare and non-Medicare patients oncology. Although we are not using and technical episode payment amounts treated with radiation during their accreditation status as a proxy for for each included cancer type. RO participation in the Model. We quality, as stated in section III.C.13.c we participants, to the extent allowed by proposed to require RO participants’ may at some point use an optional web- HIPAA and other applicable law, could submission of additional administrative based survey to gather data from reuse individually identifiable claims data upon a request from CMS, such as participants on administrative data data that they request from CMS for care the RO participant’s costs to provide points, including their accreditation coordination or quality improvement care (such as the acquisition cost of a status, indicating the importance of this work in their assessment of CMS’ linear accelerator) and how frequently information to understanding calculation of their participant-specific the radiation machine is used on an participants’ activities. To add clarity to episode payment amounts and/or average day; current EHR vendor(s); and this policy, CMS will not use the amounts included in the reconciliation accreditation status. We proposed to submission of accreditation status calculations used to determine the elicit this through annual web-based information in lieu of the quality and reconciliation payment amount or surveys. We stated in the proposed rule compliance reporting requirements. We repayment amount, as applicable. To that we would use the data requested are finalizing this policy with seek such care coordination and quality under the RO Model to monitor and modification that in response to a improvement data, we proposed that RO assess participants’ office activities, request made by CMS, RO participants participants should use a Participant benchmarks, and track to participant may volunteer to submit administrative Data Request and Attestation (DRA) compliance with applicable laws and data related to their accreditation status. form, if appropriate for that RO program requirements. 84 FR 34530. Comment: A couple of commenters participant’s situation, which will be The following is a summary of the indicated that the proposed annual available on the Radiation Oncology public comments received on this mandatory survey that CMS may use to Administrative Portal (ROAP). proposal and our responses to these request additional information, such as Throughout the Model performance comments: the cost of providing care, frequency of period, RO participants may request to Comment: A commenter expressed equipment use, EHR vendors, and continue to receive these data until the support of requiring RO participants’ accreditation status does not have a final reconciliation and final true-up submission of their accreditation status. direct relation to the Model. A process has been completed if they Response: We thank this commenter commenter further believed that such continue to use such data for care for supporting this proposed policy. information may include proprietary coordination and quality improvement Comment: A few commenters information and requested that the data purposes. At the conclusion of this requested that comprehensive radiation collected by CMS be aggregated and process, the RO participant would be oncology accreditation standards be blinded. required to maintain or destroy all data used to ensure that the quality and Response: We thank these in its possession in accordance with the compliance standards are met. One of commenters for their feedback on our DRA and applicable law. these commenters argued that utilizing proposed annual survey. We disagree We proposed that the RO participant such accreditation programs as a part of with the commenter that the additional may reuse original or derivative data CMS’ monitoring and assessment to administrative data does not have a without prior written authorization from efforts to ensure compliance with legal direct relation to the RO Model. As us for clinical treatment, care and model agreement requirements stated in the proposed rule at 84 FR management and coordination, quality would ensure that facilities demonstrate 34530, the data requested will be used improvement activities, and provider their systems, personnel, policies and to better understand participants’ office incentive design and implementation, procedures meet standards for high- activities, benchmarks, and to track but would not be permitted to quality patient care. That commenter participant compliance with the RO disseminate individually identifiable also requested that the accreditation Model requirements. We agree with the original or derived information from the requirement take effect in 2024, commenter that the data could contain files specified in the Model DRA to

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anyone who is not a HIPAA Covered cancer type be provided to RO substance use disorder services unless Entity Participant or individual participants 90 to 180 days prior to the the requestor provides a 42 CFR part 2- practitioner in a treatment relationship start of each PY. These commenters compliant authorization from each with the subject Model beneficiary; a believed that 30 days in advance is individual about whom they seek such HIPAA Business Associate of such a inadequate to analyze the data and take data. While the proffered DRA form was Covered Entity Participant or individual appropriate action with participant drafted with the assumption that most practitioner; the participant’s business partners on a timely basis. RO participants seeking claims data will associate, where that participant is itself Response: We understand these do so under the HIPAA Privacy Rule a HIPAA Covered Entity; the commenters’ concerns, yet there are a provisions governing ‘‘health care participant’s sub-business associate, number of reasons why CMS is unable operations’’ disclosures under 45 CFR which is hired by the RO participant to to provide participant-specific 164.506(c)(4), in offering RO carry out work on behalf of the Covered professional episode payment and participants the opportunity to use that Entity Participant or individual participant-specific technical episode form to request beneficiary-identifiable practitioners; or a non-participant payment amounts and these amounts 90 claims data, we do not represent that the HIPAA Covered Entity in a treatment to 180 days prior to the start of each PY. RO participant or any of its individual relationship with the subject Model First, certain pricing components used practitioners has met all applicable beneficiary. to determine the participant-specific HIPAA requirements for requesting data When using or disclosing PHI or professional episode payment and under 45 CFR 164.506(c)(4). The RO personally identifiable information (PII) technical payment amounts are derived participant and its individual obtained from files specified in the from current Medicare rates, which are practitioners should consult their own DRA, we proposed that the RO not published until November before counsel to make those determinations participant would be required to make the start of the PY for which they would prior to requesting data using the DRA ‘‘reasonable efforts to limit’’ the apply (see section III.C.6.c(1)). Instead, form. information to the ‘‘minimum as explained in section III.C.6.c(1) of Agreeing to the terms of the DRA, the necessary’’ as defined by 45 CFR this final rule, CMS will provide each RO participant, at a minimum, will 164.502(b) and 164.514(d) to RO participant its case mix and agree to establish appropriate accomplish the intended purpose of the historical experience adjustments for administrative, technical, and physical use, disclosure or request. The RO both the PC and TC, rather than their safeguards to protect the confidentiality participant would be required to further participant-specific professional and limit its disclosure of such information technical episode payment amounts, of the data and to prevent unauthorized to what is permitted by applicable law, because exact figures for the participant- use of or access to it. The safeguards including the regulations promulgated specific professional and technical will be required to provide a level and under the regulations promulgated episode payment amounts will not be scope of security that is not less than the under the HIPAA and HITECH laws at known to CMS prior to the start of the level and scope of security requirements 45 CFR part 160 and subparts A and E PY for which they would apply. established for federal agencies by the of part 164, and the types of disclosures Furthermore, we disagree with the Office of Management and Budget that the Innovation Center itself would commenter that it is standard practice in (OMB) in OMB Circular No. A–130, be permitted to make under the ‘‘routine other APMs to provide participants with Appendix I—Responsibilities for uses’’ in the applicable systems of data on a monthly basis. The data Protecting and Managing Federal records notices listed in the DRA. The provided to model participants varies Information Resources (available at RO participant may link individually across APMs and many factors https://www.whitehouse.gov/omb/ identifiable information specified in the contribute to the feasibility of providing information-for-agencies/circulars/) as DRA (including directly or indirectly such data (for example, such as scope of well as Federal Information Processing identifiable data) or derivative data to the model). At this time, given the scope Standard 200 entitled ‘‘Minimum other sources of individually of this Model, we believe it is Security Requirements for Federal identifiable health information, such as impracticable to provide RO Information and Information Systems’’ other medical records available to the participants with data on a monthly (available at http://csrc.nist.gov/ participant and its individual basis. Therefore, we are finalizing with publications/fips/fips200/FIPS-200- practitioner. The RO participant would the modification that we will provide final-march.pdf); and, NIST Special be authorized to disseminate such data RO participants with their case mix and Publication 800–53 ‘‘Recommended that has been linked to other sources of historical experience adjustments for Security Controls for Federal individually identifiable health the professional and technical Information Systems’’ (available at information provided such data has components at least thirty (30) days http://nvlpubs.nist.gov/nistpubs/ been de-identified in accordance with prior to the start of each PY (see SpecialPublications/NIST.SP.800- HIPAA requirements in 45 CFR regulatory text at § 512.255). 53r4.pdf). We proposed that the RO 164.514(b). participant would be required to We solicited public comment on our f. Access To Share Beneficiary acknowledge that the use of unsecured proposal. The following is a summary of Identifiable Data telecommunications, including the public comment received on this As discussed earlier in this final rule, insufficiently secured transmissions proposal and our response: in advance of each PY and any other over the internet, to transmit directly or Comment: A commenter requested time deemed necessary by us, we will indirectly identifiable information from that CMS provide RO participants with offer the RO participant an opportunity the files specified in the DRA or any data on a monthly basis, as this to request certain data and reports such derivative data files will be strictly commenter believed this is the standard through a standardized DRA, if prohibited. Further, the RO participant in other APMs. Some commenters appropriate to that RO participant’s would be required to agree that the data requested that the participant-specific situation. The data and reports provided specified in the DRA will not be professional episode payment and to the RO participant in response to a physically moved, transmitted, or participant-specific technical episode DRA will not include any beneficiary- disclosed in any way from or by the site payment amounts for each included level claims data regarding utilization of of the Data Custodian indicated in the

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DRA without written approval from activities in accordance with § 512.130, Additionally, we explained in the CMS, unless such movement, comply with the government’s right to proposed rule that we may employ transmission, or disclosure is required audit, inspect, investigate, and evaluate longer-term analytic strategies to by a law. At the conclusion of the RO any documents or other evidence confirm our ongoing analyses and detect Model and reconciliation process, the regarding implementation of the RO subtler or hard-to-determine changes in RO participant would be required to Model under § 512.135(a), and to retain care delivery and beneficiary outcomes. maintain or destroy all CMS data and and provide the government with access Some determinations of beneficiary any individually identifiable derivative to records in accordance with outcomes or changes in treatment in its possession as provided by the §§ 512.135(b) and (c). Additionally, delivery patterns may not be able to be DRA and any other applicable written CMS would conduct model monitoring built into ongoing claims analytic efforts agreements with CMS. activities with respect to the RO Model and may require longer-term study. This The following is a summary of the in accordance with § 512.150(b). In the work may involve pairing clinical data public comment received on section proposed rule we discussed our belief with claims data to identify specific III.13.f of the proposed rule and our that the general provisions relating to issues by cancer type. response: monitoring and compliance would be The following is a summary of the Comment: A commenter requested appropriate for the RO Model, because public comments received on this that beneficiaries be informed, prior to we must closely monitor the proposal and our responses to the participating in the RO Model, that CMS implementation and outcomes of the RO comments: proposes to collect quality, clinical, and Model throughout its duration. The Comment: A commenter expressed administrative data and would share purpose of monitoring would be to support of the proposed monitoring with RO participants certain de- ensure that the Model is implemented activities. Another commenter identified beneficiary data, and how it safely and appropriately; that RO expressed support of our proposal to will be used by CMS and RO participants comply with the terms and monitor longer-term analytic strategies participants. conditions of this rule; and to protect to confirm ongoing analyses. Response: We thank these Response: For information relating to RO beneficiaries from potential harms the data that CMS proposes to collect commenters for their support. that may result from the activities of an from RO participants, please see Comment: A commenter requested RO participant. sections III.C.8, III.C.8.c (quality that CMS clearly define the monitoring measures) and III.C.8.e (clinical data Consistent with § 512.150(b), we activities and the effect the RO Model elements) of this rule. We are finalizing anticipated that monitoring activities will have on beneficiaries. This as proposed that RO participants will be may include documentation requests commenter has also requested details on required to provide beneficiaries with sent to RO participants and individual how CMS will ensure patient the beneficiary notification letter during practitioners on the individual stakeholder groups have access to the initial treatment planning session practitioner list; audits of claims data, resulting data as well as how patient which will detail, among other things, quality measures, medical records, and advocate groups will be able to provide the RO beneficiary’s right to refuse other data from RO participants and input on what is and is not working having his or her Medicare claims data clinicians on the individual practitioner from the patient perspective. shared with the RO participant for care list; interviews with members of the Response: We believe that the RO coordination and quality improvement staff and leadership of the RO Model will improve quality of care for purposes under § 512.225(a)(2). participant and clinicians on the RO beneficiaries receiving treatment Beneficiaries who do not wish to have individual practitioner list; interviews from RO participants, and we believe their claims data shared with the RO with beneficiaries and their caregivers; that the monitoring activities as participant for care coordination and site visits; monitoring quality outcomes described in section III.C.14 will help us quality improvement purposes under and clinical data, if applicable; and to understand whether there are any the Model would be able to notify their tracking patient complaints and appeals. unintended consequences. As it relates respective RO participant; in such cases We also discussed in the proposed rule to beneficiaries, we will closely monitor the RO participant must provide (84 FR 34531 through 34532) that we beneficiary and patient complaints and notification in writing to CMS within 30 anticipated using the most recent claims survey responses to determine what is days of when the beneficiary notifies the data available to track utilization as or is not working during the test of the RO participant. described in section III.C.7 of this final Model and to mitigate unforeseen After considering public comments, rule, and beneficiary outcomes under adverse impact on RO beneficiaries. we are finalizing our proposed data the Model. More specifically, we With respect to patient stakeholder sharing policies with the modification proposed to track utilization of certain groups having access to resulting data, that requests by CMS for administrative types of treatments, beneficiary while we did not propose to share data related to the cost of providing hospitalization and emergency specific data from our monitoring and care, frequency of equipment use, EHR department use, and fractionation oversight of the Model with patient vendors, and accreditation status will be (numbers of treatments) against stakeholder groups, we will consider optional for the RO participant. We are historical treatment patterns for each that in future rulemaking. Additionally, codifying these policies at our participant. In the proposed rule, we as discussed in section III.C.13.b, we regulation at § 512.275(a)–(b). discussed our belief that this type of finalized our proposal to not restrict RO monitoring was important because as participants’ ability to publicly release 14. Monitoring and Compliance RO participants transition from patient de-identified information that We proposed at 84 FR 34531 that the receiving FFS payment to receiving new references the RO participant’s general provisions relating to (episode-based) payment, and we noted participation in the RO Model. Thus, monitoring and compliance in section that we want to ensure to the greatest RO participants may share with patient II.I of this rule would apply to the RO extent possible that the Model is stakeholder groups the information CMS Model. Specifically, RO participants effective and that RO Model shares with the RO participants based would be required to cooperate with the beneficiaries continue to receive high- on monitoring and oversight of their model monitoring and evaluation quality and medically appropriate care. performance. Therefore, patient

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stakeholder groups may have access to clinical data may also be used to ensure noted in the proposed rule that we may such resulting data that is released by that the Model is effective and that RO monitor participants to detect issues RO participants. We welcome input Model beneficiaries continue receiving with beneficiary experience of care, from patient advocate groups on the high-quality and medically appropriate access to care, or quality of care. We patient perspective on the RO Model at care. Site visits may be used to better also indicated that we may monitor the any time. understand how RO participants Medicare claims system to identify We note that an Annual Evaluation manage services, use evidence-based potentially adverse changes in referral, Report will be publicly released for each care, and practice patient-centered care. practice, or treatment delivery patterns. year of the RO Model, as is required for Site visit activities may include, but are We solicited public comment on our all Innovation Center models by section not limited to, interviewing RO proposal. The following is a summary of 1115A(b)(4). The independent participant(s) and staff, reviewing the public comments received on this evaluation will rigorously assess the records, and observing treatments. proposal and our responses to the impact of the RO Model on quality, comments: expenditures, utilization, RO a. Monitoring for Utilization/Costs and Comment: A commenter indicated beneficiary and RO participant Quality of Care that discriminatory practices and experiences with RT service use, and We proposed to monitor RO attempts to game the system must be quality of care, as well as on costs to RO participants for compliance with RO prevented and eliminated. beneficiaries and to Medicare. Detailed Model requirements. We anticipated Response: As we discussed in the methodologies and data sources used to monitoring to detect possible attempts proposed rule and this final rule, we are create these estimates will be included to manipulate the system through aware that RO participants might in each Annual Evaluation Report patient recruitment and billing manipulate patient recruitment to (additional information on the practices. The pricing methodology maximize revenue. For that reason, we Evaluation can be found in section requires certain assumptions about explained that we would be monitoring III.C.16). patient characteristics, such as compliance with RO Model-specific Comment: A commenter expressed diagnoses, age, and stage of disease, billing guidelines and adherence to concern that this Model will cause a based on the historical case mix of the LCDs, as well as our intention to shift in treatment to modalities that treat individual participants. It also assigns monitor patient and provider and tumors with large doses of radiation payments by cancer type. Because of supplier characteristics over time to over a shorter time frame, and that these features, participants could detect changes that might suggest providers and suppliers will rapidly attempt to manipulate patient attempts at such manipulation. We transition to stereotactic radiosurgery recruitment in order to maximize believe that the monitoring and (SRS) and stereotactic body radiation revenue (for example, cherry-picking, compliance requirements will mitigate therapy (SBRT) without having the lemon-dropping, or shifting patients to gaming and discriminatory practices by proper staff or necessary equipment to a site of service for which the RO participants. safely perform such procedures. This participant bills Medicare that is not in Comment: A commenter appreciated commenter has requested that CMS a CBSA randomly selected for the decision that CMS share the planned implement a program to track participation). As explained in the clinical data elements and reporting beneficiary outcomes both in terms of proposed rule, we anticipated standards with EHR vendors and survival and toxicity to avoid monitoring compliance with RO Model- radiation oncology specialty societies, unintended consequences. The specific billing guidelines and and requested that CMS also share this commenter recommended that adherence to current LCDs, which information with oncology clinical providers and suppliers track and report provide information about the only pathways developers. this outcomes data via a Medicare reasonable and necessary conditions of Response: We plan to share the Certified Quality Clinical Data Registry coverage allowed. We also intended to clinical data elements and the reporting (QCDR) like the Registry for monitor patient and provider and process publicly via the RO Model Performance and Clinical Outcomes in supplier characteristics, such as website (see sections III.C.8 and III.C.8.e Radiology (RPCR). variations in size, profit status, and of this final rule). We appreciate the Response: We thank the commenter episode utilization patterns, over time to suggestion specific to pathway for this comment and appreciate their detect changes that might suggest developers and will take this into concern. CMS will take these attempts at such manipulation. consideration. suggestions into consideration. At this To allow us to conduct this Comment: Two commenters asked time, we believe that the Model is monitoring, we proposed that RO CMS to provide specifics on how it will designed in a way that we will be able participants would report data on monitor and intervene on potential to adequately monitor RO beneficiary program activities and beneficiaries unintended consequences of the Model. outcomes and treatment delivery consistent with the data collection Response: As we previously stated, patterns to assess whether there are policies in section III.C.8 of this rule. data submitted by RO participants will unintended consequences without These data would be analyzed by CMS be analyzed by CMS or our designee for needing to use a Medicare QCDR. Please or our designee for quality, consistency, quality, consistency, and completeness. see section III.C.14.b for more and completeness; further information Further information on this analysis information relating to the monitoring on this analysis would be provided to will be provided to RO participants in activities. RO participants in a time and manner a time and manner specified by CMS Comment: A commenter requested specified by CMS prior to collection of prior to collection of this data. We will clarification regarding onsite quality this data. We would use existing use existing authority to audit claims and clinical element data audits. authority to audit claims and services, and services, to use the QIO to assess for Response: To clarify, we may utilize to use the Quality Improvement quality issues, to use our authority to onsite audits, conducted by a contractor, Organization (QIO) to assess for quality investigate allegations of patient harm, of quality and clinical data elements to issues, to investigate allegations of and to monitor the impact of the RO monitor RO Participants for model patient harm, and to monitor the impact Model quality metrics. We may monitor compliance. Audits of quality and of the RO Model quality metrics. We RO participants to detect issues with

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beneficiary experience of care, access to physician; (v) sends a treatment to the implementation of this Model as care, or quality of care. We may monitor summary to each RO beneficiary’s part of the Quality Payment Program, the Medicare claims system to identify referring physician within three months accreditation, licensing, and delivery of potentially adverse changes in referral, of the end of treatment to coordinate high-quality care. Furthermore, these practice, or treatment delivery patterns. care; (vi) discusses with each RO seven medical record documentations Should unforeseen consequences arise beneficiary prior to treatment delivery are critical for high-quality care and during the Model test, we will take his or her inclusion in, and cost-sharing necessary for evaluation of this Model. appropriate measures, including those responsibilities under, the RO Model; Therefore, we are finalizing this policy outlined in § 512.160 or modifying the and (vii) performs and documents Peer as proposed. regulatory requirements for compliance, Review (audit and feedback on Comment: A couple of commenters to mitigate such consequences. treatment plans) for 50 percent of new requested that the EHR/medical record patients in PY1, for 55 percent of new documentation requirements be b. Monitoring for Model Compliance patients in PY2, for 60 percent of new eliminated from the Model We had proposed to require all patients in PY3, for 65 percent of new requirements. These commenters participants to annually attest in a form patients in PY4, and for 70 percent of indicated that these data elements are and manner specified by CMS that they new patients in PY5 preferably before not always captured in discrete fields. will use CEHRT throughout such PY in starting treatment, but in all cases before Response: We will not be eliminating a manner sufficient to meet the 25 percent of the total prescribed dose these documentation requirements from requirements as set forth in 42 CFR has been delivered and within 2 weeks the Model as they are a necessary 414.1415(a)(1)(i), and as stated in the of the start of treatment, as stated in the component of the Model. As stated proposed rule at 84 FR 34522 through proposed rule at 84 FR 34585 through earlier in this rule’s comments and 34524. In addition, we proposed that 34586. responses, we believe that delaying the each Technical participant and Dual The following is a summary of the start date for the Model, and therefore participant be required to attest public comments received on this the collection of clinical data elements, annually that it actively participates in proposal and our responses to these until January 1, 2021, and publishing a radiation oncology-specific AHRQ- comments: the final rule several months before the listed patient safety organization (PSO). Comment: A commenter expressed Model performance period, will allow This attestation would be required to support of the required medical record participants time to become comfortable ensure compliance with this RO Model documentation regarding the goals of with other aspects of the Model and requirement. CMS may change these care, the treatment intent, the develop best practices to facilitate their attestation intervals throughout the beneficiary’s inclusion in the RO Model, data collection and work with EHR Model upon advanced written notice to and the cost-sharing responsibilities. vendors to seek additional EHR support. the RO participants. We proposed to This commenter urged CMS to develop As such, we are finalizing the codify these RO Model requirements at and consumer test language for requirement that RO participants § 512.220(a)(3). We noted that CMS may providers and suppliers to use in document the seven medical record monitor the accuracy of such discussing these complex issues. documentations set forth in section attestations and that false attestations Response: We appreciate the III.C.14.b with the modification that this will be punishable under applicable commenter’s support and suggestion. requirement begin in PY1 instead of at federal law, including but not limited to We will consider developing guidance the start of the Model. the remedial action set forth in materials that RO participants may use Comment: A commenter expressed § 512.160(b). to ensure adherence to the Model support for the PSO participation In addition, we proposed to monitor requirements. Should such materials be requirement. for compliance with the other RO Model developed, the RO participants will be Response: We thank the commenter requirements listed in this section notified and those materials will be for this support. through site visits and medical record made available on the RO Model Comment: A few commenters were audits conducted in accordance with website at https://innovation.cms.gov/ concerned with the proposed § 512.150, and as stated in the proposed initiatives/radiation-oncology-model/. requirement of attesting annually to rule at 84 FR 34581 through 34582. We Comment: A commenter expressed active participation in a radiation proposed to codify at § 512.220(a)(2) our concern that the Innovation Center oncology-specific PSO. These requirement that all Professional would not have the resources to commenters requested clarity on the participants and Dual participants effectively monitor the number of PSO requirement and asked whether document in the medical record that the proposed RO participants. participation in any PSO could meet the participant: (i) Has discussed goals of Response: We will be utilizing a compliance requirement as one of these care with each RO beneficiary before contractor to effectively monitor the commenters noted that there are fees initiating treatment and communicated activities of the RO participants. associated with joining a PSO. There to the RO beneficiary whether the Comment: A couple of commenters were also concerns with the time and treatment intent is curative or palliative; expressed frustration with the EHR data resources it takes to join a PSO. (ii) adheres to nationally recognized, reporting requirements and asserted that Response: After reviewing these evidence-based clinical treatment these requirements would be comments, we are finalizing this guidelines when appropriate in treating administratively burdensome for RO proposed policy with modification. RO RO beneficiaries, or documents in the participants. participants will annually attest to medical record the rationale for the Response: We appreciate the whether they actively participate in a departure from these guidelines; (iii) commenters’ concerns; however, we patient safety organization, but we will assesses the RO beneficiaries’ tumor, disagree with these commenters’ no longer require that the participant be node, and metastasis (TNM) cancer argument that such reporting in a radiation oncology-specific PSO. stage for the CMS-specified cancer requirements are excessively Instead, RO participants will be in diagnoses; (iv) assesses the RO burdensome. Many of these compliance so long as they annually beneficiary’s performance status as a requirements are already being captured attest to active participation with any quantitative measure determined by the by RT providers and RT suppliers prior PSO. We believe that this modification

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will alleviate the commenter’s concern participation in the Model. Therefore, future rulemaking with a public of paying additional fees to participate we are finalizing our monitoring comment period. We will take your with a radiation oncology-specific PSO policies related to the use of nationally request for an exemption for small/rural when an RO participant is already recognized, evidence-based clinical practices under consideration and participating in a non-radiation practice guidelines as proposed. proceed with future rulemaking should oncology-specific PSO. We are also Comment: A commenter requested it become necessary during the test of removing the text ‘‘PSO provider service that CMS provide a list of approved, this Model. However, we believe that agreement’’ and replacing it with ‘‘for nationally recognized, evidence-based the use of CBSAs as the geographic unit example, by maintaining a contractual clinical treatment guidelines to RO of selection minimizes the number of or similar relationship with a PSO for participants. rural providers and suppliers that will the receipt and review of patient safety Response: We do not believe that it is be selected in the Model. We have also work product’’ for alignment with the necessary for us to provide such a list finalized an option for low-volume RT terminology used by AHRQ. as radiation oncologists have the providers and RT suppliers to opt out of Additionally, the PSO requirement will knowledge and ability to determine the Model as described in section be effective beginning in PY1. For those what nationally recognized, evidence- III.C.3.c of this final rule and codified at RO participants that are not in a PSO, based clinical treatment guidelines are § 512.210(c). they can use the time period from the applicable to their patient population. Comment: A commenter has inquired publication of this final rule until the Comment: A commenter requested how TNM staging will be used by CMS, attestation period near the end of PY1 clarification on how clinical decision and specifically asked whether it would to initiate participation with a PSO. support will be assessed and be used in the AJCC staging system. Comment: A commenter documented if it is not common in Additionally, this commenter has recommended that we collect data on radiation oncology software. requested clarification on how CMS will participation in the Radiation Oncology Specifically, this commenter expressed handle cancer types that do not have a Incident Learning System (RO–ILS). concerns with documenting adherence TNM staging system. Response: We thank this commenter to nationally recognized, evidence- Response: We appreciate the for the suggestion. At this time, we will based treatment guidelines or rationale importance of staging in the diagnosis, not be modifying our proposed for departure from those guidelines. prognosis, and treatment of cancer. The monitoring policies to include data Response: We believe that publishing four quality measures for the RO Model collection on participation in the RO– the final rule more than 60 days prior beginning in PY1 and continuing ILS because we believe that our to the start date will provide RO thereafter, as described in section monitoring policies as finalized are participants with time to facilitate III.C.8.b of this rule, do not rely on appropriate for the monitoring and medical record software updates to staging data. As we review which evaluation of this Model. include appropriate fields to comply clinical data elements are appropriate Comment: A commenter thanked with the data submission and for inclusion in the RO Model, we will CMS for recognizing the importance of monitoring requirements of the Model. consider staging data if these elements nationally recognized, evidence-based Comment: A commenter supported are determined to meet RO Model goals clinical practice guidelines. This the qualified peer review requirement as of eliminating unnecessary or low-value commenter has noted that CMS can being consistent with the CMS ‘‘Patients care, developing accurate episode determine guideline adherence through over Paperwork’’ initiative. prices, or developing new radiation the use of various HIT systems and real- Response: We thank the commenter oncology-specific quality measures. time clinical decision support for this support. After considering public comments, applications which can be integrated Comment: Some commenters we are finalizing our proposed policies into electronic health record (EHR) expressed concerns with the peer on monitoring for Model compliance systems. A couple of commenters review requirements as being onerous with the modifications, as previously requested clarification on the for RO participants, particularly single discussed, related to active participation requirement to discuss goals of care practitioners and those practicing in in a PSO (the PSO requirement will be with each Medicare beneficiary as the underserved areas (that is, rural and effective beginning in PY1, but RO treatment intent is not always provided some urban settings). These commenters participants are not required to be in a as a data field in oncologist’s asked for either the elimination of or a radiation oncology-specific PSO) and information systems. phased-in approach for the peer review peer review (will begin in PY1). We are Response: We appreciate the requirements. A commenter requested codifying these policies at §§ 512.150 commenter bringing HIT systems and that there be an exemption to those and 512.220. real-time clinical decision support small/rural practices that show good- applications to our attention, and we faith in trying to comply. c. Performance Feedback note that we do not believe that these Response: We understand We proposed to provide detailed and systems are necessary at this point. We commenters’ concerns with the actionable information regarding RO also appreciate the commenters’ proposed policy on peer review as this participant performance related to the requests for clarification on the currently may not be a common practice RO Model. We stated in the proposed requirement to discuss goals of care among certain RT providers and RT rule that we intend to leverage the with each RO beneficiary. To add suppliers, but this is common practice clinical data to be collected through the clarity, we are committed to supporting for larger RT providers and RT suppliers RO Model secure data portal, quality the efforts of RO participants to work and those seeking accreditation. After measure results reported by RO with their EHR vendors to facilitate this considering comments received, we are participants, claims data, and change to capture the seven activities finalizing with modification the peer compliance monitoring data to provide required under the Model. We believe review requirement. The peer review information to participants on their that publishing the final rule several requirements will be finalized as adherence to evidence-based practice months before the Model performance proposed with reporting to begin in guidelines, quality and patient period will allow RO participants and PY1. A good faith exemption for those experience measures, and other quality EHR vendors to prepare for small/rural practices would require initiatives. We discussed our belief that

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these reports can drive important The beneficiary notice would include, shared under § 512.225(a)(2). We believe conversations and support quality along with other pertinent information, that having a template with only improvement progress. The design of how to contact CMS with questions. minimal modifications (RO participant and frequency with which these reports Specifically, if beneficiaries have any contact information, logo, and date) will would be provided to participants questions or concern with their not lead to potentially inaccurate would be determined in conjunction physicians, we stated in the proposed information being delivered to with the RO Model implementation and rule that we encouraged them to beneficiaries. Further, after considering monitoring contractor. telephonically contact the CMS using 1– comments regarding administrative We solicited public comment on our 800–MEDICARE, or their local burden, we are finalizing as proposed proposal. We received no comments on Beneficiary and Family Centered Care- that RO participants provide this this proposal and therefore are Quality Improvement Organizations written notice to each beneficiary finalizing this policy as proposed. (BFCC–QIOs) (local BFCC–QIO contact during the initial treatment planning information can be located here: https:// session. We do not believe that a written d. Remedial Action for Non-Compliance www.qioprogram.org/locate-your-qio). notice that has minimal modification by We refer readers to section II.I of this We solicited public comment on the the RO participant is an administrative final rule for our proposals regarding beneficiary protections. In this section burden on RO participants. remedial action. of this rule, we summarize and respond Additionally, we believe that this notice to the public comments received on this serves an important function to ensure 15. Beneficiary Protections proposal. that beneficiaries are aware of the Model We proposed to require Professional Comment: A commenter requested and how they may be impacted by it, as participants and Dual participants to that CMS make a concerted public effort well as allowing them to choose a non- toward educating all beneficiaries who notify RO beneficiaries that the RO participant health care provider should may be impacted by the Model about participant was participating in this RO they wish. the unique coinsurance requirements Model by providing written notice to We appreciate the comment about inherent to the Model’s design. having additional sources for the each RO beneficiary during the RO Response: As required by beneficiary notification such as the beneficiary’s initial treatment planning § 512.225(a)(3) of this final rule, RO Medicare.gov website, and we will session. In the proposed rule, we noted participants must notify all RO consider ways to provide RO that we intended to provide a beneficiaries to whom they furnish beneficiaries with details about the RO notification template that RO included RT services regarding their participants may personalize with their cost-sharing responsibilities. Such Model. We recognize that the Medicare contact information and logo, which notice will be furnished through the & You publication has included would explain that the RO participant is beneficiary notification letter provided language about model tests in the past. participating in the RO Model and by the RO participant during the initial However, that publication cannot would include information regarding treatment planning session and may be provide beneficiaries with the specific RO beneficiary cost-sharing discussed prior in accordance with details and parameters for every model responsibilities and an RO beneficiary’s § 512.225(a)–(c) of this final rule. The test. Therefore, we will consider other right to refuse having his or her data beneficiary notification requirement ways to provide RO beneficiaries with shared under § 512.225(a)(2). will begin in PY1. details about the RO Model. Beneficiaries who do not wish to have Comment: We received some Additionally, as we draft the beneficiary their claims data shared for care comments on the beneficiary notification letter, we will ensure that coordination and quality improvement notification letter. These commenters the language used is simple to provide purposes under the Model would be requested that we eliminate the beneficiaries with the necessary able to notify their respective RO requirement for the RO participant to information to convey that they are participant. In such cases, the RO notify the beneficiaries as such receiving treatment from an RO participant must notify in writing CMS notification is administratively participant. within 30 days of when the RO burdensome. A commenter also Comment: A commenter supported beneficiary notifies the RO participant. expressed concerns with the timing of the proposal that CMS draft the We discussed in our proposed rule the beneficiary notification letter. A beneficiary notification letter template. our belief that it will be important that commenter requested that CMS provide Response: We appreciate this RO participants provide RO this notice within the Medicare & You commenter’s support. beneficiaries with a standardized, CMS- annual publication as well as on the Comment: A commenter noted that developed RO beneficiary notice in Medicare.gov website. Another the RO Model references patient order to limit the potential for fraud and commenter requested that if we finalize navigators in its discussion of the abuse, including patient steering. The the notification letter as proposed then Oncology Care Model, but there is an required RO Model beneficiary notice to draft the notice with simple language absence of provisions calling for the would be exempt from the provision at at less than a 6th grade reading level. inclusion of such within the RO Model. § 512.120(c)(2), and discussed in section Response: After considering This commenter believes that the II.D.3 of this rule, that requires a comments, we are finalizing as episodic nature of radiation oncology standard disclaimer statement on all proposed that we will draft the coupled with the potential number of descriptive model materials. In the beneficiary notification template that health care provider touchpoints for proposed rule, we discussed our belief RO participants may personalize with patients in the RO Model augments the that the disclaimer statement should not their contact information and logo, importance of patient navigators in apply to the RO Model beneficiary which will explain that the RO ensuring an effective continuum of care notice, because RO participants would participant is participating in the RO for patients receiving RT. This be required to use standardized Model and will include information commenter voiced a strong language developed by CMS. We regarding RO beneficiary cost-sharing recommendation to include a prominent proposed for these policies to be in responsibilities and an RO beneficiary’s role for patient navigators in the RO § 512.225(c). right to refuse having his or her data Model.

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Response: We thank this commenter declines claims data sharing for care In addition to assessing the impact of for highlighting the important role coordination and quality improvement the Model in achieving improved patient navigators have. To the extent purposes, then the RO participant must quality and reduced Medicare that an RO participant wishes to include inform CMS within 30 days of receiving expenditures, we stated in the proposed patient navigators in the care team, this notification from the RO beneficiary that rule that the evaluation is likely to will be permissible, but at this time, we the beneficiary is declining to have their address secondary questions to provide will not be formally incorporating a claims data shared in that manner. We context for answers to the primary requirement that RO participants are codifying at § 512.225(a)(3) that question. As stated in the proposed rule, include patient navigators in the care of starting in PY1, Professional these questions include (but will not be RO beneficiaries. We do not believe that participants and Dual participants must limited to): Did utilization patterns with there is a demonstrated need for patient notify each RO beneficiary to whom it respect to modality or number of navigation at this time in radiation furnishes included RT services of the fractions per episode change under the oncology, particularly as many radiation RO beneficiary’s cost-sharing model? If the Model results in lower oncology patients who also receive responsibilities. Medicare expenditures, what aspects of chemotherapy typically receive care the Model reduced spending and were 16. Evaluation management services from their medical those changes different across oncologist. However, after the Model is As stated in the proposed rule, an subgroups of beneficiaries or related to implemented, we will assess the need evaluation of the RO Model would be observable geographic or socio- for patient navigators and, if needed, required to be conducted in accordance economic factors? Did any observed make modifications to the RO Model with section 1115A(b)(4) of the Act, differences in concordance with through future rulemaking. which requires the Secretary to evaluate evidence-based guidelines vary by Comment: A commenter has each model tested by the Innovation cancer type or by treatment modality? expressed concerns that the proposed Center (84 FR 34533). Did patient experience of care improve? RO Model will create a burden on As stated in the proposed rule our Did the Model affect access to RT or patients, such as increasing the need for evaluation would focus primarily on the other services overall or for vulnerable those patients to drive farther to obtain question: Do the changes that comprise populations? Were there design and the same quality of care. the RO Model result in improved implementation issues with the RO Response: We do not agree with the quality or reduced spending for those Model? What changes did participating commenter’s assertion that the Model beneficiaries receiving RT services radiation oncologists and other RO care will increase the need for beneficiaries during the model period? Conversely, if team members experience under the to drive farther. We believe that the RO Model has no effect we would Model? Did any unintended providing site-neutral, more predictable expect that Medicare spending per consequences of the Model emerge? Was or foreseeable payments to RO episode or quality measures for there any observable overlap between participants will help patients because beneficiaries associated with those the RO Model and other Innovation we anticipate that the Model will lead episodes do not differ between RT Center models or CMS/non-CMS to lower costs overall while maintaining providers and suppliers in CBSAs initiatives and how could they impact or improving quality of care. The RO selected as Participants in the Model the evaluation findings (84 FR 34533)? beneficiaries receiving care from RO compared to those in the comparison As stated in the proposed rule, CMS participants will maintain the same group. We will also analyze other data anticipated that the evaluation will protections as those beneficiaries to understand how the Model is include a difference-in-differences 80 or outside of the Model, including the right successful in achieving improved similar analytic approach to estimate to choose their health care providers. quality and reduced expenditures. model effects (84 FR 34533). Where it is After considering public comments, These analyses may include changes in available, baseline data for the we are finalizing our proposed RT utilization patterns (including the participants would be obtained for at provisions on beneficiary protections number of fractions and types of RT), least one year prior to model with the modification of non- RT costs for Medicare FFS beneficiaries implementation. Data would also be substantive changes to the proposed in the RO Model (including Medicare- collected during model implementation provisions at § 512.225 in this final rule Medicaid dually eligible beneficiaries), for both participant and comparison to improve readability. The beneficiary changes in utilization and costs with groups. The evaluation would control notification requirement will begin in other services that may be affected as a for patient differences and other factors PY1. Specifically, we are codifying the result of the RO Model (such as that directly and indirectly affect the RO beneficiary notification requirement at emergency department services, Model impact estimate, including § 512.225. Furthermore, we are imaging, prescription drugs, and demographics, comorbidities, program codifying at § 512.225(a)(1) that starting inpatient hospital care), performance on in PY1, Professional participants and clinical care process measures (such as 80 Difference-in-difference is a statistical Dual participants must notify each RO adhering to evidence-based guidelines), technique that compares the intervention (in this beneficiary to whom it furnishes patient experience of care, and provider case, the RO participant) and comparison (in this included RT services that the RO and supplier experience of care. The case, the Comparison group) groups during the period before the RO Model goes into effect (pre- participant is participating in the RO evaluation would inform the Secretary intervention) and the period during and after the Model. We are codifying at and policymakers about the impact of RO Model goes into effect (post-intervention) and § 512.225(a)(2) that starting in PY1, the model relative to the current uses the difference between intervention and Professional participants and Dual Medicare fee structure for RT services, comparison in both periods to estimate the effect of the intervention. A comparison group that is similar participants must notify each RO assessing the impacts on beneficiaries, to the intervention group is used to help measure beneficiary to whom it furnishes health care providers, markets, and the the size of the intervention effect by providing a included RT services that the RO Medicare program. The evaluation comparison (or ‘counterfactual’) to what would beneficiary has the opportunity to would take into account other models have happened to the intervention group had the intervention not occurred. This helps the evaluation decline claims data sharing for care and any changes in Medicare payment distinguish between changes occurring for reasons coordination and quality improvement policy during the Model performance unrelated to the Model when estimating the purposes; and that if an RO beneficiary period (84 FR 34533). changes that occurred because of the Model.

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eligibility, and other factors. Data to Response: We agree that burden on that the RO Model would be compatible control for patient differences would be RO participants should be minimized to with other CMS models and programs obtained primarily from claims and the extent possible, and we kept this in that also provide health care entities patient surveys. mind in the design of the RO Model, with opportunities to improve care and The evaluation would use a including the evaluation. We included reduce spending. We expected that multilevel approach. We would conduct features in the Model such as RO there would be situations where a analyses at the CBSA-level, participant- participants continuing to submit claims Medicare beneficiary in an RO Model level, and the beneficiary-level. The through the existing FFS claims process, episode would also be assigned to, or CBSAs and RT providers and RT and identifying RO participants by ZIP engage with, another payment model suppliers contained within CBSA Code (rather than CBSA) to limit being tested by CMS. Overlap could also geographic areas selected for burden. We have been mindful to occur among providers and suppliers at participation, as discussed in section minimize RO participant burden in the the individual or organization level; for III.C.3.d, will have been randomly design of the evaluation (such as relying example, a physician or organization assigned for the duration of the on secondary data sources such as FFS could be participating in multiple evaluation, allowing us to use claims), but there will be some models tested by the Innovation Center. scientifically rigorous methods for additional data collection necessary to We stated that we believe that the RO evaluating the effect of the Model. fully evaluate the Model and conduct all Model would be compatible with other We referred readers to section II.E of impact estimates. CMS initiatives that provide the proposed rule for our proposed Comment: A couple of commenters opportunities to improve care and policy on RO participant cooperation expressed concern that the Model as reduce spending, especially population- with the RO Model’s evaluation and proposed may lack sufficient data to based models, though we recognize the monitoring policies. We solicited public evaluate the effects of including PBT design of some models being tested by comment on our proposed approach centers. the Innovation Center under its section related to the evaluation of the RO Response: We focused the evaluation 1115A authority could create Model. In this section of the rule, we design on the impacts of the Model at unforeseen challenges at the summarize and respond to the public the population level for overall organization, clinician, or beneficiary comments received on this proposal. spending and quality across all RT level. We stated in the proposed rule Comment: A few commenters services furnished and not the effects on that we do not envision that the expressed concern about possible one potential modality compared to prospective episode payments made unforeseen circumstances and another. While some future sub-analyses under the RO Model would need to be unintended consequences as a result of may include differences in costs and adjusted to reflect payments made the Model. A couple of these quality by modality, we will make no under any of the existing models being commenters urged us to evaluate model impact estimates on cost nor quality tested under 1115A of the Act or the Shared Savings Program under section effects on quality of care and patient where we do not have suitable sample 1899 of the Act. We stated in the access and were concerned the RO size of RO participants or RO episodes, proposed rule that if, in the future, we Model may impact these outcomes understanding that any differences we determined that such adjustments are negatively. A commenter suggested we may observe are observational and not necessary, we would propose overlap did not have sufficient evidence to causative. policies for the RO Model through proceed with the Model. A different After considering public comments, notice and comment rulemaking. In this commenter offered support for the we are finalizing our proposals on section of this rule, we summarize and proposed evaluation and highlighted the evaluation as proposed. respond to the public comments importance of patient experience 17. Termination of the RO Model received on the proposal in section measures with regards to cancer care. In the proposed rule, we stated that III.C.18.a. Response: We appreciate and share Comment: A few commenters the commenters’ interest in outcomes the general provisions relating to termination of the Model by CMS in generally agreed with CMS’ approach related to the Model. In designing the not to propose to adjust the RO Model’s Model and planning the Model’s section II.J of the proposed rule would apply to the RO Model. We received no prospective episode payments to reflect evaluation, CMS considers access to payments made under any of the comments on the termination of the RO care and quality of care to be outcomes existing models being tested under Model. As explained in section II.J. of that must be examined. We have a section 1115A of the Act or under the this final rule, we are finalizing our monitoring plan for tracking, and an Shared Savings Program. They also proposal to apply § 512.165 to the RO evaluation plan to assess, the Model’s agreed that other models and programs Model. impact on these outcomes. We believe should be responsible for factoring RO collecting and analyzing measures of 18. Potential Overlap With Other Model payments into their quality and access to care will help Models Tested Under Section 1115A reconciliation calculations. assess the Model’s impact on Authority and CMS Programs Response: We appreciate the beneficiaries’ outcomes and experience commenters’ support. during RO episodes. We have detailed a. Overview Comment: Some commenters the methodology used to create the We stated in the proposed rule (84 FR requested more information and clearer episodes, set payment rates, and the 34533 through 34535) that the RO guidance from CMS on overlap between random selection of Participants in the Model would leverage existing the RO Model and other CMS NPRM, using national FFS Medicare Innovation Center work and initiatives, initiatives, including all models tested claims. We are finalizing the evaluation broadening that experience to RT under section 1115A, the Shared and monitoring methods as proposed. providers and RT suppliers, a Savings Program, and the Quality Comment: A commenter encouraged professional population that is not Payment Program. One of these the agency to make it a priority to currently the focus of other models commenters stated that without details minimize provider and supplier burden tested by the Innovation Center. In the of how CMS proposes to resolve resulting from this Model. proposed rule, we discussed our belief overlaps, providers and suppliers are

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unable to accurately forecast how the policies for the RO Model through to evaluate the potential effect of models may impact future revenues, notice and comment rulemaking. specialty and other episode payment and they requested that, in the future, Further, we are not including further models on global payments and total CMS needs to provide more specific explanation in this final rule regarding cost of care, and there is a finite guidance during the proposal phase, so overlap policies for the RO Model, opportunity for these organizations to stakeholders can comment on any because we are not putting in place any reduce costs while maintaining access potential issues prior to overlap accounting policies for this and quality. To address these concerns, implementation. Another commenter Model at this time. As explained this commenter recommended a encouraged CMS to provide additional previously, the financial methodology hierarchical approach to CMS’ and the clarity on payment adjustment changes and accounting policies under the Innovation Center’s model overlap, in and overlap between the RO model and applicable model tested under section which precedence is given to Quality Payment Program, and stated 1115A of the Act or the Shared Savings population health risk-bearing entities. that such clarity will greatly help them Program will govern the way in which The commenter also suggested that CMS develop forecasting models that can in RO payments are factored into use the existing payment model turn help better support their patient reconciliation calculations under that classification framework refined by the care operations. Another commenter initiative. Health Care Payment Learning & Action stated that the lack of clarity on model Comment: A few commenters Network (LAN) as a basis for its overlap overlap continues to be an issue, and expressed concern that CMS does not policy. that they have long encouraged CMS to have a clear overlap policy that is Response: We thank the commenters be more deliberate and specific in applied across all programs and models. for their comments and suggestions providing Innovation Center model One of these commenters stated that it regarding a larger CMS overlap policy. participants with clear guidance on how is very important for CMS to consider We appreciate this feedback, and will scenarios in which Innovation Center model overlap in the design of new consider all of these recommendations models overlap will be treated. This APMs, and they recommended that the moving forward, in the event that a commenter further stated that such goal of CMS models should be to broader overlap policy is developed for clarity is not only beneficial for those provide APM participants with CMS. As stated in the proposed rule, we providers and suppliers that will be adequate flexibility to manage overlap do not envision that the prospective required to participate under the RO based on their unique market situation episode payments made under the RO Model but, importantly, for those and fundamentally change care delivery Model will need to be adjusted to reflect providers and suppliers participating in and improve population health, rather payments made under any of the the other models identified by CMS in than seeking opportunities to leverage existing models being tested under the proposed rule. Another commenter market dynamics to reduce costs. This section 1115A of the Act or the Shared agreed with CMS’ acknowledgement commenter also expressed concern that Savings Program under section 1899 of that accounting resolution will be the proposed models do not place the Act, but as stated in the proposed needed for overlap between the RO sufficient emphasis on population rule, if we determine in the future that Model and other initiatives, but they health and encouraging providers and such adjustments are necessary, we believe that it is not clear how this suppliers to keep patients from getting would propose overlap policies for the accounting resolution would be to later disease stages in the first place. RO Model through notice and comment Another commenter stated that CMS handled, and specifically requested that rulemaking. must consider how models will interact CMS clarify how the overlap of the RO with one another and what this means b. Accountable Care Organizations Model with other models and programs for participation in different models. (ACOs) would be operationalized through This commenter recommended that In the proposed rule, we discussed program accounting, so that providers CMS should focus on supporting our belief that there would be potential and suppliers that participate in providers and suppliers currently not overlap between the RO Model and multiple initiatives have a clear participating in an APM and ACO initiatives. ACO initiatives include understanding of the process. Another encouraging these providers and a shared savings component. As a result, commenter requested specific suppliers to participate, rather than providers and suppliers that participate clarification on how CMS will resolve requiring some providers and suppliers in an ACO are generally prohibited from the separation of radiation oncologists to participate, in a second model, participating in other CMS models or from overlapping initiatives, for especially without sufficient clarity on initiatives involving shared savings.81 example, the MIPS adjustment earned in how these models may interact. The We believed there would be potential previous years and OCM inclusion up to commenter also supported CMS’ goal to for overlap between the RO Model and the start date of the RO Model. transition providers and suppliers to ACO initiatives but, because the RO Response: We appreciate the risk-bearing programs and believed CMS Model is an episode-based payment commenters’ comments, feedback, and will most effectively achieve this goal initiative, providers and suppliers suggestions regarding overlap between by focusing on providers and suppliers participating in the RO Model would the RO Model and other CMS not currently participating. Another not be precluded from also participating initiatives. We will take all of these commenter stated concern that the lack in an ACO initiative. Specifically, we suggestions into consideration as we of a strict overlap structure undermines believed overlap could likely occur in implement the RO Model. As stated in the financial integrity of early adopters two instances: (1) The same provider or the proposed rule, if, in the future, we in high-risk Advanced APM models, as supplier participates in both a Medicare determine that RO Model payment the absence of an established overlap adjustments are necessary to reflect framework effectively creates a 81 The statutory limitation under section payments made under any of the disincentive for providers and suppliers 1899(b)(4) of the Social Security Act, only applies existing models being tested under to voluntarily bear heightened risk for a to providers and suppliers that participate in Shared Savings Program ACOs. As a policy matter, section 1115A of the Act or the Shared total population. The commenter further CMS has elected to impose a similar restriction on Savings Program under section 1899 of stated that providers and suppliers are some participants in other ACO initiatives through the Act, we will propose overlap not equipped with enough information the participation agreements for the various models.

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ACO initiative and the RO Model; or (2) to account for discounts embedded in services from attribution to an RO a beneficiary that is aligned to an ACO RO Model payments. participant under the RO Model. One of participating in a Medicare ACO Response: At this time, we are not these commenters requested that CMS initiative receives care at a radiation planning to negatively adjust ACO ‘‘provide an exemption for practices that oncology provider or supplier outside financial calculations to account for the are already contracted with ACOs to the ACO that is participating in the RO RO discount. ACO financial calculations provide a four percent or greater Model. rely on Medicare Part A and Part B discount.’’ This commenter believes that While shared savings payments made claims data as well as non-claims-based ‘‘two percent to four percent should not under an ACO initiative have the payments that are individually automatically be withheld up front potential to overlap with discounts and identifiable final payments made under under the assumption that there were withholds in the RO Model, as we a demonstration, pilot, or time limited errors in billing’’ and that ‘‘this practice explained in the proposed rule it is program and paid from the Medicare is unfair to those that work diligently to difficult to determine the level of Trust Funds. Under the Shared Savings bill with accuracy and effectively under potential overlap at this time. It is also Program, use of a regional growth rate ethical billing practices.’’ Another difficult to determine how many ACO- should ultimately account for changes commenter suggested that CMS should aligned beneficiaries will require RT in payment due to the RO Model, in exclude all beneficiaries aligned to services or if those beneficiaries would cases where overlap occurs between the ACOs from attribution to participants in seek care from an RO participant. Given RO Model and Shared Savings Program any other payment models to reduce that the RO Model is expected to reduce ACOs. The application of a regional duplicative care coordination efforts Medicare spending in aggregate, we growth rate under the Shared Savings and create a clear, transparent and anticipated that in most cases payments Program would account for changes in understandable policy across all models under the RO Model would be less than payment due to the RO Model because tested under section 1115A of the Act. what Medicare would have paid outside the historical benchmark calculated for Response: We appreciate the the Model. However, we also noted that an ACO would be updated for each commenters’ feedback. We did not it would be possible for RO participants performance year of the agreement propose to exclude RT practices to receive higher Medicare payments period using a blend of the national participating in ACOs from the RO under the Model than they did growth rate and a regional growth rate Model, and we are finalizing our historically, for example, if they have based on the actual Medicare FFS proposed policy to allow ACO-aligned certain experience adjustments. While experience in counties where the ACO’s beneficiaries to be attributed to practices we expected overall payments for RT beneficiaries reside. Thus, the use of participating in the RO Model for the services to be lower than they would be this regional growth rate will naturally following reasons. First, we believe that absent the Model, we wanted to ensure update the historical benchmarks of excluding beneficiaries that have been that a significant proportion of the RO ACOs to account for the effects on aligned to an ACO from the RO Model Model discounts, which represent spending resulting from implementation would be operationally challenging for Medicare savings, would not be paid out of other value-based payment models, RO participants who will be billing to ACOs as shared savings. including the RO Model, in those prospective RO Model payments and Due to these factors, in the proposed counties. For ACO initiatives other than may not be aware in real time that the rule we stated that we intended to the Shared Savings Program, CMS will beneficiaries are aligned to an ACO. continue to review the potential overlap determine whether an adjustment to the Further, we believe the incentives under with the ACO initiatives as the RO initiative’s calculations is necessary the RO Model and the ACO initiatives Model is launched. If substantial based, for example, on the extent of are aligned appropriately to support overlap occurs, we would consider health care practitioner or beneficiary high-quality care, and to the extent that adjusting the RO Model payments overlap between that initiative and the RO participants provide more efficient through future rulemaking to ensure RO Model. We intend to continue to care to ACO-aligned beneficiaries, this Medicare retains the discount amount. review the potential overlap with ACO could benefit the performance of the ACO initiatives could also consider initiatives as the RO Model is launched. ACO and provide higher-quality care to accounting for RO Model overlap in If CMS determines that adjustment to Medicare beneficiaries with cancer who their own reconciliation calculations. the calculations used in any of these receive RT services. Any changes to the payment other ACO initiatives is necessary to c. Oncology Care Model (OCM) calculations under these ACO initiatives account for overlap with the RO Model, that might be necessary to account for CMS would make changes to the OCM seeks to provide higher quality, overlap with the RO Model would need governing documentation for that ACO more highly coordinated oncology care to be made using the relevant initiative, as necessary, and would at the same or lower cost to Medicare. procedures for the applicable ACO provide information to the participants OCM episodes encompass a 6-month initiative. For example, if the Next in that ACO initiative through its typical period that is triggered by the receipt of Generation ACO Model makes any channels of communication at that time chemotherapy and incorporate all changes to their current payment in the future. Similarly, we will aspects of care during that timeframe, methodologies to account for the RO consider adjusting the RO Model including RT services. Because OCM Model, it would update their governing payments through future rulemaking if and the RO Model both involve care for documentation as necessary, and would necessary to ensure Medicare retains the patients with a cancer diagnosis who provide information to their participants discount amount. However, for the receive RT services, we stated in the through their typical channels of reasons as previously described, we are proposed rule that we expect that there communication. not currently applying any adjustments will be beneficiaries who would be in In this section of this rule, we to the RO Model payments or ACO both OCM episodes and the RO Model summarize and respond to the public financial calculations at this time. episodes. comments received on this proposal. Comment: A few commenters Under OCM, physician practices may Comment: A few commenters recommended that CMS finalize a receive a performance-based payment recommended that CMS not negatively policy to exclude beneficiaries aligned (PBP) for episodes of care surrounding adjust ACO shared savings calculations to an ACO who receive included RT chemotherapy administration to cancer

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patients. OCM is an episode payment unaffected. If an entire RO Model would be notified and provided with model that incentivizes care episode (90-days of RT services) occurs further information through OCM’s coordination and management and completely during a 6-month OCM typical channels of communication. In seeks to improve care and reduce costs episode, then the associated RO this section of this rule, we summarize for cancer patients receiving payments for RT services would be and respond to the public comments chemotherapy. Given the significant included in the OCM episode. In received on this proposal. cost of RT, OCM episodes that include addition, to account for the savings Comment: Many commenters agreed RT services receive a risk adjustment generated by the RO Model discount with CMS’ proposed approach for when calculating episode benchmarks, and withhold amounts, we stated in the accounting for overlap between OCM with the goal of mitigating incentives to proposed rule that we would add the and the RO Model. Some commenters shift these services outside the episode RO Model’s discount and withhold requested additional details regarding (for example, by delaying the provision amounts to the total cost of the OCM the proration methodology, and a of RT services until after the 6-month episode during OCM’s reconciliation commenter specifically requested episode ends). process to ensure that there is no double further clarification regarding how As we explained in the proposed rule, counting of savings and no double prorated payments will be determined practices participating in OCM receive a payment of the withhold amounts and how prorated payments will be monthly payment per OCM beneficiary between the two models. distributed to providers and suppliers. to support enhanced services such as In those cases where the RO Model One commenter requested that CMS patient navigation and care planning. episode would occur partially within an clarify and reconsider how the RO Practices may also earn a PBP for OCM episode and partially before or Model will overlap with the OCM in a reductions in the total cost of care after the OCM episode, we proposed to manner that allows for full and fair compared to episodes’ target amount, allocate the RO Model payments for RT participation in both models. This with the amount of PBP being adjusted services and the RO Model discount and commenter suggested that it would be by the practice’s performance on quality withhold amounts to the OCM episode more appropriate and fairer to RT measures. OCM offers participating on a prorated basis, based on the providers and RT suppliers practices the option of requesting a two- number of days of overlap. In this case, participating in both models to use the sided risk arrangement, in which the prorated portion of the payment final discounted amount of the RO episode expenditures that exceed the under the RO Model, based on the Model payment as the payment to the target amount or the target amount plus number of days of overlap with the RO participant for purposes of the OCM the minimum threshold for OCM OCM episode, would be included in the reconciliation calculation. This recoupment (depending on the specific OCM episode’s expenditures as well as commenter stated that RO participants two-sided risk arrangement requested) the prorated portion of the RO Model would receive no financial credit under would be recouped by CMS from the discount and withhold amounts, again the RO Model for adjusting their practice. OCM requires participating based on the number of days of overlap spending to make do with lower practices who have not earned a PBP by with the OCM episode. We stated that payment under the discounts, so there the initial reconciliation of the model’s including the prorated discount and is no double-counting of savings if that fourth performance period to move to a withhold amounts would ensure that discount is also included in the OCM two-sided risk arrangement or terminate there is no double counting of savings calculation. The commenter also stated their participation in the model. and no double payment of the withhold that there is no guarantee that RO As we proposed in section III.C.7 of amounts between the two models. participants will earn the withhold the proposed rule and are finalizing in In those cases where the RO Model amounts back after reconciliation under section III.C.7 of this final rule, the RO episode occurs entirely within or the RO Model; and that even if they do, Model will include prospective episode partially before or after the OCM it likely will not be without the RO payments for RT services furnished episode, for the purpose of calculating participant incurring other costs to during a 90-day episode of care. The RO OCM episode costs, we stated in the comply with quality reporting Model is not a total cost of care model proposed rule that we would assume requirements. Therefore, this and includes only RT services in the that all withholds are eventually paid to commenter suggested that the fairer and episode payment. Since the RO Model the RO Participant under the RO Model, more accurate approach would be to makes prospective payments for only and that there are no payments to deduct the discount amount from the the RT services provided during an recoup. We stated that we believe a OCM reconciliation calculation, and to episode, a practice participating in the process to allocate exact amounts paid deduct the amount of withholding that RO Model would receive the same to the participants with different is not regained through quality prospective episode payment for RT reconciliation timelines between the performance. services regardless of its participation in two models would be operationally Response: We appreciate the OCM. complex. commenters’ support for the proposed Conversely, OCM is a total cost of care We stated in the proposed rule that approach to account for overlap model so any changes in the cost of RT we intend to continue to review the between the OCM and RO Model. We services during an OCM episode could potential overlap with OCM if the RO anticipate that roughly 30 percent of affect OCM episode expenditures, and Model is finalized, including whether OCM practices that provide RT services therefore, have the potential to affect a there are implications for OCM’s will participate in the RO Model. Since participating practice’s PBP or prediction model for setting risk- OCM is a total cost of care model, any recoupment. We stated in the proposed adjusted target episode prices, which changes in the cost of RT services rule that when the RO Model episode include receipt of RT services. We during an OCM episode could affect occurs completely before or completely further stated that since prospective OCM episode expenditures, and after the OCM episode, then the RT episode payments made under the RO therefore have the potential to affect a services that are part of that RO Model Model would not be affected by OCM, participating practice’s PBP or episode would not be included in the OCM would account for RO Model recoupment. We proposed a proration OCM episode, and the OCM overlap in its reconciliation approach to account for changes in reconciliation calculations would be calculations, and OCM participants OCM episode expenditures due to RO

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Model overlap, and to ensure there is no RO participants may keep the savings participants should be exempt from the double counting of savings or double that accrue for RO episodes where RO Model, and with the payment of the withhold amounts payment under Medicare FFS would recommendation that OCM participants between the two models. have been less than the RO participant- not be required to participate in the RO Regarding the comments about the specific episode payment. Since the RO Model until performance under OCM proration methodology, we refer readers participant would retain these savings, has concluded. We believe that it is to our description of the OCM proration we continue to believe that the best way important to allow eligible health care methodology set forth in the proposed to ensure that Medicare savings providers to participate in both models rule, where we described how, in cases (captured through the RO Model because both models involve care for where the RO episode occurs partially discount) are not paid out through the patients with a cancer diagnosis. We within an OCM episode and partially OCM reconciliation is by adding the RO also believe that participation in both before or after the OCM episode, we Model discounts and withholds to the models could benefit beneficiaries in proposed to allocate the RO Model RO participant-specific episode both the RO Model and OCM by payments for RT services and the RO payments included in the OCM aligning payment incentives across both Model discount and withhold amounts reconciliation calculations. models. We did not propose to exclude to the OCM episode’s expenditures on a Additionally, we are not able to OCM participants from the RO Model as prorated basis, based on the number of synchronize the timing of the OCM and we believe that this approach would days of overlap. As we discussed in the RO Model reconciliations such that we curtail the number, and potentially alter proposed rule, including the RO could incorporate the amount of the the composition, of RT providers and discount and withhold amounts (on a quality withhold that is paid to the RO RT suppliers available to participate in prorated basis for cases where the RO participant during reconciliation. the RO Model, which could affect our episode occurs partially within an OCM Comment: A few commenters ability to detect an impact of the RO episode and partially before or after the requested that CMS not make changes to Model. Further, by not excluding OCM episode) in the calculation of the OCM target price setting voluntary OCM participants, we could OCM episode expenditures would methodology based on RO Model avoid a possible selection effect in the ensure that there is no double counting payments. RO Model. of savings and no double payment of the Response: We noted in the proposed After review of public comments and withhold amounts between the two rule that overlap with the RO Model for the reasons discussed, we are models. For cases where the RO episode may have implications for the finalizing our proposed approach for occurs entirely within or partially before appropriateness of OCM’s prediction addressing overlap between OCM and or after the OCM episode, for the model for setting risk-adjusted target the RO Model as proposed. purpose of calculating OCM episode prices. We are continuing to consider costs, we stated that we would assume whether any potential changes to OCM’s d. Bundled Payments for Care that all withholds are eventually paid to prediction model would be needed, and Improvement (BPCI) Advanced the RO participant under the RO Model, we appreciate this input from the As we explained in the proposed rule, and that there are no payments to commenters. If we make changes to the the BPCI Advanced Model is testing a recoup. As we discussed in the OCM prediction model, OCM practices new iteration of bundled payments for proposed rule, we believe a process to would be notified through OCM’s 34 clinical episodes (30 inpatient and 3 allocate exact amounts paid to the RO typical communication channels. outpatient, and 1 multi-setting).82 The Comment: A few commenters participants when the OCM and the RO BPCI Advanced Model is based on a requested clarity and guidance from Model have different reconciliation total cost of care approach with certain CMS about whether the RO Model and timelines would be operationally MS–DRG exclusions. While there are no OCM payments are paid separately or complex. Further detail about how OCM cancer episodes included in the design bundled together. will account for RO Model overlap in its of the BPCI Advanced Model, a Response: The RO Model and OCM reconciliation calculations will be beneficiary in an RO episode could be are separate and distinct payment provided to OCM practices through treated by a provider or supplier that is models and any model payments will be OCM’s typical communication participating in the BPCI Advanced paid separately and not bundled channels. Of note, any RO episode Model for one of the 34 clinical together. Furthermore, as stated in the payments that are prorated as part of the episodes included in the BPCI OCM reconciliation calculations will proposed rule, a practice participating Advanced Model. Since prospective not be distributed to the RO participant in the RO Model will receive the same episode payments made under the RO or OCM participant; rather, these prospective episode payment for RT Model would not be affected by the amounts will be included in the OCM services, regardless of its participation BPCI Advanced Model, the BPCI reconciliation calculations that in OCM, because the RO Model makes Advanced Model would determine determine the amount of any OCM PBP prospective payments for only the RT whether to account for RO Model or OCM recoupment. RO episode services provided during an RO episode. overlap in its reconciliation payments would not change as a result Comment: A commenter suggested the calculations, and CMS would provide of any overlap with an OCM episode. OCM participants should be exempt We believe the proposed approach to from the RO Model. A couple of further information to the BPCI handling the RO Model discount and commenters suggested that OCM Advanced Model participants through withholds in the OCM reconciliation participants should not be required to an amendment to their participation calculation is fair to participants in both participate in the RO Model until their agreement. In this section of this rule, models and allows for full participation performance under OCM has been we summarize and respond to the in both models, while also preventing completed. public comments received on this us from double-counting and double- Response: We appreciate the proposal. paying savings to Medicare. Of note, RO commenter’s suggestion about excluding 82 Major joint replacement of the lower extremity participants receive the same RO OCM participants from the RO Model. is a multi-setting Clinical Episode category. Total payment amount regardless of how However, we disagree with the Knee Arthroplasty (TKA) procedures can trigger many RT services are delivered; thus, commenters’ recommendation that OCM episodes in both inpatient and outpatient settings.

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Comment: A commenter Model’s pricing methodology gives Program and the Comprehensive Care recommended that potential RO Model significant weight to historical for Joint Replacement Model, and also overlap with the BPCI Advanced Model experience in determining the amounts in the Quality Payment Program. be addressed through a notice and for participant-specific professional We appreciate the commenters’ public comment process, rather than episode payments and participant- feedback on this issue. We will consider through a mandatory amendment to the specific technical episode payments. these comments when determining BPCI Advanced Model participant This is particularly evident in PY1, whether a hardship exemption is agreements. A commenter stated that where the efficiency factor in section appropriate for proposing in subsequent there may be potential overlap with the III.C.6.e(2) of the proposed and final rulemaking for a future PY. We will BPCI Advanced Model, as a Medicare rules is 0.90 for all RO participants. continue to monitor the need for a beneficiary in an RO episode could be Accordingly, we did not propose such hardship exemption under the RO treated by a health care provider that is an exemption in the proposed rule, and Model. participating in the BPCI Advanced will not include such an exemption in IV. End-Stage Renal Disease (ESRD) Model. This commenter requested this final rule. Treatment Choices Model clarification in this case, on how to However, in the proposed rule, we know which model the patient would be welcomed public input on whether a A. Introduction attributed to and how the services possible hardship exemption for RO The purpose of this section of the would be reimbursed. This commenter participants under the Model might be final rule is to implement a new also recommended that CMS address necessary or appropriate, and if so, how payment model called the End-Stage the potential overlap on how patients it might be designed and structured Renal Disease (ESRD) Treatment should be attributed between the BPCI while still allowing CMS to test the Choices (ETC) Model, referred to in this Advanced Model and the RO Model, Model. As we stated in the proposed section IV of the final rule as ‘‘the and they requested further clarification rule, we intend to use the input we Model,’’ under the authority of the regarding how services will be received on this issue to consider Innovation Center. The intent of the reimbursed under the RO and BPCI whether a hardship exemption might be ETC Model is to test whether adjusting Advanced Models before the start date appropriate in subsequent rulemaking the current Medicare fee-for-service to assist hospitals in effective planning for a future PY. In this section of this (FFS) payments for dialysis services will for their participation. rule, we summarize the public incentivize ESRD facilities and Response: We appreciate the comments we received. clinicians managing adult Medicare FFS commenter’s concerns and suggestions. Comment: Many commenters beneficiaries with ESRD, referred to The BPCI Advanced Model payment disagreed with CMS’ decision not to herein as Managing Clinicians, to work polices are governed by participation include a model participation hardship with their patients to achieve increased agreements with each model exemption for RO participants. A rates of home dialysis utilization and participant; we cannot amend those commenter requested that CMS kidney transplantation and, as a result, agreements by notice and comment establish a hardship exemption process improve or maintain the quality of care rulemaking. Accordingly, we are for RT providers and RT suppliers that and reduce Medicare expenditures. Both finalizing as proposed (84 FR 34535) can show they serve a patient base of these modalities (home dialysis and that the BPCI Advanced Model team consisting predominantly of Medicare transplantation) have support among will determine whether and how to beneficiaries, given that these providers health care providers and patients as account for RO Model overlap in its and suppliers would face preferable alternatives to in-center reconciliation calculations. Regarding disproportionate impact from hemodialysis (HD), but the utilization the commenter who requested mandatory participation in the Model rate of these services in the United clarification on how to know which and would be at a significant States (U.S.) has been below such rates model the patient would be attributed to disadvantage compared to other in other developed nations.83 On July and how the services would be participants as well as RT providers and 18, 2019, we published a proposed rule reimbursed, as we stated in the RT suppliers not included in the Model. in the Federal Register titled ‘‘Medicare Some commenters requested a proposed rule, a beneficiary in an RO Program; Specialty Care Models To hardship exemption specific to rural episode could be treated by a provider Improve Quality of Care and Reduce practices. These commenters or supplier that is participating in the Expenditures’’ (84 FR 34478) and sought maintained that patients living in rural BPCI Advanced Model, and prospective public comment on the proposed ETC areas would be disparately impacted by episode payments made under the RO Model. In response, CMS received 104 the mandatory requirement of the Model would not be affected by the comment submissions from physicians, proposed RO Model, and other BPCI Advanced Model. As such, the dialysis providers, patient groups, commenters stated that rural practices BPCI Advanced Model would determine industry groups, and others. Summaries will experience undue burdens if they whether to account for RO Model of these comments, and our responses, are required to participate in the RO overlap in its reconciliation are found throughout this section of the Model. calculations, and the BPCI Advanced final rule. A few commenters recommended that Model participants will receive further In the ETC Model, CMS will adjust CMS provide hardship exemptions for information from CMS if the BPCI Medicare payments under the ESRD RO participants facing public health Advanced Model team determines to Prospective Payment System (PPS) to emergencies or natural disasters, such as make changes to their reconciliation ESRD facilities and payments under the policy. wild fires, earthquakes, or hurricanes, to ensure that they are not unfairly 19. Decision Not To Include a Hardship 83 United States Renal Data System. 2018 USRDS penalized due to these circumstances. annual data report: Epidemiology of kidney disease Exemption These commenters stated that hardship in the United States. National Institutes of Health, As discussed in the proposed rule (84 exemptions for extreme and National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 2018. Volume 2: FR 34535), we did not believe that a uncontrollable circumstances have End-stage Renal Disease (ESRD) in the United hardship exemption for participation in recently been implemented in other States. Chapter 11: International Comparisons. the Model is necessary, since the APMs, including the Shared Savings Figures 11–15, 11–16.

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Medicare Physician Fee Schedule (PFS) patient experience represents a critical described in the proposed rule and to Managing Clinicians paid the ESRD dimension for assessing treatment. The previously in this final rule, for testing Monthly Capitation Payment (MCP) substantially higher expenditures and the ETC Model. Several commenters selected for participation in the Model. hospitalization rates for ESRD stated that the evidence suggests that The payment adjustments will include Beneficiaries compared to the overall home dialysis and transplantation are an upward adjustment on home dialysis Medicare population, and higher associated with lower costs and better and home dialysis-related claims with mortality than in other countries outcomes than in-center dialysis for claim service dates during the initial indicate a population with poor clinical patients with ESRD, and that the current three years of the ETC Model, that is, outcomes and potentially avoidable payment system does not encourage the between January 1, 2021 and December expenditures. We anticipate that the use of these alternative modalities. A 31, 2023. In addition, we will make an ETC Model will maintain or improve few commenters stated that payment upward or downward performance- the quality of care for ESRD adjustments like those we proposed for based adjustment on all dialysis claims Beneficiaries and reduce expenditures use in the ETC Model can impact and dialysis-related claims with claim for the Medicare program by creating participant behavior in supporting these service dates between July 1, 2022 and incentives for health care providers to alternative modalities. A few June 30, 2027, depending on the rates of assist beneficiaries, together with their commenters stated that containment of home dialysis utilization, and of kidney families and caregivers, to choose the dialysis costs is an important goal for transplant waitlisting and living donor optimal renal replacement modality for the Model. transplants among the beneficiaries the beneficiary. Response: We thank the commenters attributed to these participating ESRD As we discussed in the proposed rule, for their feedback and support. facilities and Managing Clinicians. The the majority of ESRD patients receiving Comment: Several commenters stated ETC Model will test whether such dialysis receive HD in an ESRD facility. that they did not believe payment payment adjustments can reduce total At the end of 2016, 63.1 percent of all adjustments could change participant program expenditures and improve or prevalent ESRD patients—meaning behavior to increase rates of home maintain quality of care for Medicare patients already diagnosed with ESRD— dialysis and transplantation. A beneficiaries with ESRD. in the U.S. were receiving HD, 7.0 commenter stated that any payment percent were being treated with adjustments are unlikely to overcome B. Background peritoneal dialysis (PD), and 29.6 barriers that currently prevent the use of 1. Rationale for the ESRD Treatment percent had a functioning kidney home dialysis and transplantation such Choices Model transplant.87 Among HD cases, 98.0 as socioeconomic issues, race, immunologic barriers, a lack of As discussed in the proposed rule, percent used in-center HD, and 2.0 caregiver support, housing insecurity beneficiaries with ESRD are among the percent used home hemodialysis 88 and home environments that are unable most medically fragile and high-cost (HHD). PD is rarely conducted within to store supplies and equipment. A populations served by the Medicare a facility. In the proposed rule and in commenter stated that the evidence that program. ESRD Beneficiaries require section IV.B.2 of this final rule, we home dialysis is associated with better dialysis or kidney transplantation in describe how current Medicare payment outcomes and lower costs is mixed, so order to survive, as their kidneys are no rules and a lack of beneficiary education the payment adjustments proposed for longer able to perform life-sustaining result in a bias toward in-center HD, use in the Model are unlikely to achieve functions. In recent years, ESRD which is often not preferred by patients the stated goals. A commenter stated Beneficiaries have accounted for about 1 or practitioners. With the ETC Model, percent of the Medicare population and we will test whether new payment that, if under current payment accounted for approximately 7 percent adjustments will lead to greater rates of conditions patient preference is not of total fee-for-service Medicare home dialysis (both PD and HHD) and driving renal replacement modality spending.84 Beneficiaries with ESRD kidney transplantation. In both the selection, then changing payment face the need for coordinating treatment proposed rule and this final rule, we incentives will not move patient for many disease complications and provide evidence from published preference to the center of the decision- comorbidities, while experiencing high literature to support the projection that making process. Response: We thank the commenters rates of hospital admissions and higher utilization rates for these specific readmissions and a mortality rate interventions would likely reduce for their feedback. The purpose of the greatly exceeding that of the general Medicare expenditures, while ETC Model is to test whether the Medicare population. In addition, preserving or enhancing the quality of payment adjustments included in the studies during the past decade have care for beneficiaries and, at the same Model will reduce Medicare reported higher mortality rates for time, enhance beneficiary choice, expenditures while improving or dialysis patients in the U.S. compared to independence, and quality of life. maintaining quality of care. CMS The following is a summary of the other countries.85 86 believes that these payment adjustments ESRD is a uniquely burdensome comments received on the rationale for will accomplish these goals by condition; with uncertain survival, testing the proposed ETC Model and our encouraging participating Managing responses. Clinicians and ESRD facilities to Comment: Several commenters stated 84 Kirchoff SM. Medicare Coverage of End-Stage support beneficiaries choosing home Renal Disease (ESRD). Congressional Research that they support the rationale, as dialysis and transplantation. The Service. August 16, 2018. p. 1. purpose of the Model and CMS’s 85 Foley RN, Hakim RM. Why Is the Mortality of 87 United States Renal Data System, Annual Data evaluation thereof is to determine if this Dialysis Patients in the United States Much Higher Report, 2018. Volume 2. Chapter 1: Incidence, than the Rest of the World? Journal of the American Prevalence, Patient Characteristics, and Treatment is the case. Society of Nephrology. 2009; 20(7):1432–1435. Modalities. https://www.usrds.org/2018/view/v2_ doi:https://doi.org/10.1681/ASN.2009030282. 01.aspx. a. Home Dialysis 86 Robinson B, Zhang J, Morgenstern H, et al. 88 United States Renal Data System, Annual Data As we noted in the proposed rule, Worldwide, mortality is a high risk soon after Report, 2018. Volume 2. Chapter 1: Incidence, there are two general types of dialysis: initiation of hemodialysis. Kidney Prevalence, Patient Characteristics, and Treatment International.2014;85(1):158–165. Doi:10.1038/ Modalities. https://www.usrds.org/2018/view/v2_ HD, in which an artificial filter outside ki.2013.252. 01.aspx. of the body is used to clean the blood;

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and PD, in which the patient’s percentage of beneficiaries that were As we noted in the proposed rule, the peritoneum, covering the abdominal dialyzing at home (12 percent). For high rate of incident dialysis patients organs, is used as the dialysis example, the U.S. rate of home dialysis beginning dialysis through in-center HD membrane. HD is conducted at an ESRD is significantly below those of Hong in the U.S. is driven by a variety of facility, usually 3 times a week, or at a Kong (74 percent), New Zealand (47 factors including ease of initiation, patient’s home, often at a greater percent), Australia (28 percent), and physician experience and training, frequency. PD most commonly occurs at Canada (25 percent).93 misinformation around other the patient’s home. (Although PD can be As discussed in the proposed rule, a modalities, inadequate education for furnished within an ESRD facility, it is 2011 report on home dialysis in the U.S. chronic kidney disease (CKD) very rare. In providing background related the relatively low rate of home beneficiaries, built-up capacity at ESRD information for the ETC Model in the dialysis in this country to factors that facilities, and a lack of infrastructure to proposed rule and in this final rule, we included educational barriers, the support home dialysis.95 (Provision of consider PD to be exclusively a home monthly visit requirement for the MCP home dialysis requires a system of modality.) Whether a patient selects HD under the PFS, the need for home care distribution of supplies to patients, as or PD may depend on a number of partner support, as well as philosophies well as allocation of staff and space factors, such as patient education before and business practices of dialysis within facilities for education, training, dialysis initiation, social and care providers, such as staffing allocations, clinic visits, and supervision). One partner support, socioeconomic factors, lack of independence for home dialysis study indicated that patients’ perceived and patient perceptions and knowledge about various ESRD 89 90 clinics, and business-oriented preference. restrictions that lead to inefficient therapies was correlated with their As discussed in the proposed rule, supply distribution. The report understanding of the advantages and when Medicare began coverage for recommended consolidated, disadvantages of the available treatment individuals on the basis of ESRD in 96 collaborative efforts to enhance patient options. As discussed in the proposed 1973, more than 40 percent of dialysis education among nephrology practices, rule, researchers have reported that patients in the U.S. were on HHD. More dialysis provider organizations, hospital greater support, training, and education favorable reimbursement for outpatient systems and kidney-related to nephrologists, other clinicians, and dialysis and the introduction in the organizations, as well as additional patients would increase the use of both 1970s of continuous ambulatory educational opportunities and training HHD and PD. A prospective evaluation peritoneal dialysis, which required less for nephrologists and dialysis staff. With of dialysis modality eligibility among intensive training, contributed to a patients with CKD stages III to V relative decline in HHD utilization.91 regard to CMS’s requirement starting in 2011 that the physician or non- enrolled in a North American cohort Overall, the proportion of home dialysis study showed that as many as 85 patients in the U.S. declined from 1988 physician practitioner furnish at least one in-person patient visit per month percent were medically eligible for to 2012, with the number of home PD.97 However, in one study, only one- dialysis patients increasing at a slower for home dialysis MCP services, the report noted that CMS allows discretion third of ESRD patients beginning rate relative to the total number of all maintenance dialysis were presented dialysis patients. As cited in a U.S. to Medicare contractors to allow payment without a visit so long as there with PD as an option, and only 12 Government Accountability Office percent of patients were presented with (GAO) report, according to U.S. Renal is evidence for the provision of services HHD as an option.98 As shown by a Data System (USRDS) data, throughout the month. Nevertheless, the national pre-ESRD education initiative, approximately 16 percent of the 104,000 report concluded that notwithstanding pre-dialysis education results in a 2- to dialysis patients in the U.S. received this allowance the stated policy might 3- fold increase in the rate of patients home dialysis in 1988; however, by potentially be a disincentive for initiating home dialysis compared with 2012, the rates of HHD and PD physicians to promote home dialysis. the U.S. home dialysis rate.99 Another utilization were 2 and 9 percent, The report further commented that the study reported 42 percent of patients respectively.92 low rate of home dialysis in the U.S. Additionally, as outlined in the may result in part from patients’ inability to perform self-care, and 95 Ghaffarri A, Kalantar-Zadeh K, Lee J, Maddux proposed rule, an annual analysis F, Moran J, Nissenson A. PD First: Peritoneal performed by the USRDS in 2018 suggested providing support for home Dialysis as the Default Transition to Dialysis compared the rates of dialysis care partners. With respect to dialysis Therapy. Seminars in Dialysis. 2013; 26(6): 706– modalities for prevalent dialysis providers’ business practices and 713. doi: 10.1111/sdi.12125. patients in the U.S. to 63 selected philosophies, the report noted that 96 Finkelstein FO, Story K, Firanek C, Barr P, et dialysis providers differ in many ways al. Perceived knowledge among patients cared for countries or regions around the world. by nephrologists about chronic kidney disease and In 2016, the U.S. ranked 27th in the and have different experiences that end-stage renal disease therapies. Kidney deserve attention and consideration International 2008; 9: 1178–1184. https://doi.org/ 89 Stack AG. Determinants of Modality Selection with regard to potentially posing a 10.1038/ki.2008.376. among Incident US Dialysis Patients: Results from barrier to the provision of home 97 Mendelssohn DC. Mujais SK, Soroka, SD, et al. a National Study. Journal of the American Society dialysis.94 A prospective evaluation of renal replacement of Nephrology. 2002; 13: 1279–1287. Doi 1046– therapy modality eligibility. Nephrology Dialysis 6673/1305–1279. Transplantation. 2009; 24(2): 555–561. doi: https:// 90 Miskulin DC, et al. Comorbidity and Other 93 United States Renal Data System, Annual Data doi.org/10/1093/ndt/gfn484. Factors Associated With Modality Selection in Report, 2018. Volume 2, Chapter 11: International 98 Mehrotra R, Marsh D, Vonesh E, Peters V, Incident Dialysis Patients: The CHOICE Study. Comparisons. Figure F11.12. Nissenson A. Patient education and access of ESRD American Journal of Kidney Diseases. 2002; 39(2): 94 Golper TA, Saxena AB, Piraino B, Teitelbaum, patients to renal replacement therapies beyond in- 324–336. Doi 10.1053/ajkd.2002.30552. I, Burkart, J, Finkelstein FO, Abu-Alfa A. Systematic center hemodialysis. Kidney International. 2005; 91 Blagg CR. A Brief History of Home Barriers to the Effective Delivery of Home Dialysis 68(1):378–390. Hemodialysis. Annals in Renal Replacement in the United States: A Report from the Public 99 Lacson E, Wang W, DeVries C, Leste K, Hakim Therapy. 1996; 3: 99–105. Policy/Advocacy Committee of the North American RM, Lazarus M, Pulliam J. Effects of a Nationwide 92 Unites States Government Accountability Chapter of the International Society for Peritoneal Predialysis Educational Program on Modality Office. End Stage Renal Disease: Medicare Payment Dialysis. American Journal of Kidney Diseases. Choice, Vascular Access, and Patient Outcomes. Refinements Could Promote Increased Use of Home 2011; 58(6): 879–885.doi:10.1053/ American Journal of Kidney Diseases. 2011; 58(2): Dialysis (GAO–16–125). October 2015. j.ajkd.2011.06.028. 235–242.doi:10.1053/j.ajkd.2011.04.015.

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preferring PD when the option was the comparative cost and effectiveness to HD.115 Therefore, as noted in the presented to them.100 of different dialysis modalities assess proposed rule, we believe increased Recent studies show substantial PD versus HD. As noted in the proposed rates of PD associated with increased support among nephrologists and rule, we believe that since the extent of rates of home dialysis prompted by the patients for dialysis treatment at in-center PD is negligible, and only proposed Model would at least home.101 102 103 104 105 As we noted in the approximately 2 percent of HD occurs at maintain, and may improve, quality of proposed rule, we believe that home, these studies are suitable for care provided to ESRD Beneficiaries. increasing rates of home dialysis has the drawing conclusions regarding home While studies from several nations potential to not only reduce Medicare versus in-center dialysis.) However, observe that the survival advantage for expenditures, but also to preserve or research on cost differences between in- PD may be attenuated following the enhance the quality of care for ESRD center dialysis and home dialysis is early years of dialysis treatment (1 to 3 Beneficiaries. limited to comparing costs for patients years), and also that advanced age and As discussed in the proposed rule, who currently dialyze at home to those certain comorbidities among patients research suggests that dialyzing at home who do not. As previously discussed in are related to less favorable outcomes is associated with lower overall medical the proposed rule and in this final rule, for PD, as we discussed in the proposed expenditures than dialyzing in-center. there are currently barriers to dialyzing rule, a component of the Model’s Key factors that may be related to lower at home that may result in selection evaluation would be to assess the expenditures include potentially lower bias. Put another way, beneficiaries who applicability of these findings to the rates of infection associated with currently dialyze at home may be U.S. population and Medicare dialysis treatment, fewer different in some way from beneficiaries beneficiaries, specifically if hospitalizations, cost differentials who dialyze in-center that is otherwise there is sufficient statistical power between PD and HD services and the cause of the observed difference in to detect meaningful supplies, and lower operating costs for overall medical expenditures. Patients variation.116 117 118 119 120 121 122 Patient dialysis providers for providing home may differ in terms of age, gender, race, benefits of HHD and PD also can 106 107 108 109 110 dialysis. (Most studies on and clinical issues such as presence of include better quality of life and greater diabetes and origin of ESRD.111 Despite independence.123 124 125 As described in 100 Maaroufi A, Fafin C, Mougel S, Favre G, Seitz- selection bias present in existing greater detail in the proposed rule and Polski P, Jeribi A, Vido S, Dewismi C, Albano L, research, we stated in the proposed rule Esnault V, Moranne O. Patient preferences throughout section IV of this final rule, regarding choice of end-stage renal disease our expectation that increasing rates of one of the aims of the ETC Model is to treatment options. American Journal of Nephrology. home dialysis will likely decrease test whether new payment incentives 2013; 37(4): 359–369. doi: 1159/000348822. Medicare expenditures for ESRD 101 Rivara MB, Mehrotra R. The Changing Beneficiaries, and this is something we 115 Landscape of Home Dialysis in the United States. United States Renal Data System. Annual Data Current Opinion in Nephrology and would assess as part of our evaluation Report, 2018. Volume 2, Chapter 5: Mortality. Hypertension.2014; 23(6):586–591.doi:10.1097/ of the ETC Model. Figure 5.1. Mortality rates were adjusted for age, MNH0000000000000066. In addition, as we discussed in the sex, race, ethnicity, primary diagnosis and vintage. 102 Mehrotra R, Chiu YW, Kalantar-Zadeh K, proposed rule, current research on 116 Li KP, Chow KM. Peritoneal Dialysis—First Bargman J, Vonesh E. Similar Outcomes With Policy Made Successful: Perspectives and Actions. Hemodialysis and Peritoneal Dialysis in Patients patients in the U.S. and Canada American Journal of Kidney Diseases. 2013; 62(5): With End-Stage Renal Disease. Archives of Internal indicates similar, or better, patient 993–1005. doi: http://dx/doi.org/10.1053/ Medicine. 2011; 171(2): 110–118. Doi:10.1001/ survival outcomes for PD compared to j.ajkd.2013.03.038. archinternmed.2010.352. HD.112 113 114 (As previously noted, most 117 Yeates K, Zhu N, Vonesh E, Trpeski L, Blake 103 Ghaffari et al. 2013. research on the comparative P, Fenton S. Hemodialysis and peritoneal dialysis 104 Ledebo I, Ronco C. The best dialysis therapy? are associated with similar outcomes for end-stage Results from an international survey among effectiveness of different dialysis renal disease treatment in Canada. Nephrology nephrology professionals. Nephrology Dialysis modalities compares PD to HD, but—as Dialysis Transplantation. 2012; 27(9): 3568–3575. Transplantation.2008;6:403–408.doi:10.1093/ noted in the proposed rule—we believe doi: https://doi.org/10.1093/ndt/gfr/674. ndtplus/sfn148. these studies are suitable for comparing 118 Chiu YW, Jiwakanon S, Lukowsky L, Duong U, 105 Kalantar-Zadeh, Mehrotra R. An Update on the Schiller B, Neitzer A, Doss S. Perceptions home to in-center dialysis, given that in- about renal replacement therapy among nephrology Comparisons of Mortality Outcomes of professionals. Nephrology News & Issues. center PD is negligible and only Hemodialysis and Peritoneal Dialysis Patients. September 2010; 36–44. approximately 2 percent of HD is Seminars in Nephrology. 2011; 31(2): 152–158. 106 Walker R, Marshall MR, Morton RL, conducted at home.) The USRDS shows Doi:10.1016/j.semnephrol.2011.01.004. 119 McFarlane P, Howard K. The cost-effectiveness of lower adjusted all-cause mortality rates Mehrotra et al. 2011. contemporary home hemodialysis modalities 120 Sinnakirouchenan R, Holley JL. 2011. compared with facility hemodialysis: A systematic for 2013 through 2016 for PD compared 121 Quinn RR, Hux JE, Oliver MJ, Austin, PC, review of full economic evaluations. Nephrology. Tonelli M, Laupacis A. Selection Bias Explains 2014; 19: 459–470 doi: 10.1111/nep.12269. Access Issues. Advances in Chronic Kidney Apparent Differential Mortality between Dialysis 107 Walker R, Howard K, Morton R. Home Disease. 2011; 18(6): 428–432. doi: 10.1053/ Modalities. Journal of the American Society of hemodialysis: A comprehensive review of patient- j.ackd.2011.09.001. Nephrology. 2011; 22(8) 1534–1542. doi: 10.1681/ centered and economic considerations. 111 United States Renal Data System, Annual Data ASN.2010121232. ClinicoEconomics and Outcomes Research. 2017; 9: Report, 2018. Volume 2, Chapter 1: Incidence, 122 Weinhandl ED, Foley RN, Gilbertson DT, 149–161. Prevalence, Patient Characteristics, and Treatment Arneson TJ, Snyder JJ, Collins AJ. Propensity- 108 Howard K, Salkeld G, White S, McDonald S, Modalities. Table 1. Matched Mortality Comparison of Incident Chadban S, Craig J, Cass A. The cost effectiveness 112 Wong B, Ravani P, Oliver MJ, Holroyd-Leduc Hemodialysis and Peritoneal Dialysis Patients. of increasing kidney transplantation and home- J, Venturato L, Garg AX, Quinn RR. Comparison of Journal of the American Society of Nephrology. based dialysis. Nephrology. 2009; 14: 123–132 doi: Patient Survival Between Hemodialysis and 2010; 21(3): 499–506. doi: 10.1681/ 10.1111/j.1440–1797.2008.01073.x. Peritoneal Dialysis Among Patients Eligible for Both ASN.2009060635: 10.1681/ASN.2009060635. 109 Quinn R, Ravani P, Zhang X, Garg A, Blake P, Modalities. American Journal of Kidney Diseases. 123 Ghaffari et al. 2013. Austin P, Zacharias JM, Johnson JF, Padeya S, 2018; 71(3) 344–351. doi:10.1053/ 124 Rivara and Mehrotra. 2014. Verreli M, Oliver M. Impact of Modality Choice on j.ajkd.2017.08.028. 125 Juergensen E, Wuerth D, Finkelstein SH et al., Rates of Hospitalization in Patients Eligible for Both 113 Kumar VA, Sidell MA, Jones JP, Vonesh EF. Hemodialysis and Peritoneal Dialysis: Patients’ Peritoneal Dialysis and Hemodialysis. Peritoneal Survival of propensity matched incident peritoneal Assessments of Their Satisfaction with Therapy and Dialysis International. 2014; 34(1): 41–48 doi: and hemodialysis patients in a United States health the Impact of the Therapy on their Lies. Clinical 10.3447/pdi.2012.00257. care system. Kidney International. 2014; 86: 1016– Journal of American Society of Nephrology. 2006; 110 Sinnakirouchenan R, Holley, J. Peritoneal 1022. doi:10.1038/ki.2014.224. 1(6): 1191–1196. DOI: https://doi.org/10.2215/ Dialysis Versus Hemodialysis: Risks, Benefits, and 114 Mehrotra et al. 2011. CJN.01220406.

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would lead to greater rates of home payment system that disincentivize transplant in the current Medicare FFS dialysis. home dialysis, including the ability for payment system. The following is a summary of the Managing Clinicians to maximize We recognize that educating patients comments received on the benefits of revenue through in-center dialysis over about their renal replacement options is and barriers to home dialysis and our home dialysis, and Medicare key to supporting modality selection. As responses. requirements around MCP monthly in- such, we are waiving certain Comment: Several commenters person visits for home dialysis requirements for the Kidney Disease expressed support for the association beneficiaries. A commenter stated that Education (KDE) benefit to allow between home dialysis and improved the requirements for an ESRD facility to Managing Clinicians who are ETC health outcomes in comparison to in become certified to provide home Participants additional flexibility to center dialysis. Commenters stated that dialysis are burdensome and prevent furnish and bill for these educational research suggests that HHD facilitates some ESRD facilities from seeking services under the Model. These longer, more frequent dialysis, or certification to begin a home dialysis waivers are detailed in section IV.C.7.b optimal dialysis dosing for the of this final rule. program. Commenters identified individual patient, which in turn leads In response to the commenters’ to better health outcomes and quality of system-level factors related to the concerns about system-level factors, life. Commenters also stated that supply of goods and services necessary including products and services research suggests other benefits to home to conduct home dialysis, including necessary to home dialysis provision, dialysis, including need for fewer dialysis supplies in general and PD we have designed the benchmarking medications, less frequent solution in particular, availability of and scoring methodology, described in hospitalizations, and better quality of vascular access services, and lack of section IV.C.5.d of this final rule, to be life. A commenter stated that there is new technology and innovation in the comparative to account for these types evidence that suggests that HHD can home dialysis industry. Commenters of system-level factors. In the initial have long term outcomes that are equal discussed a lack of access to primary years of the Model, participant to or better than deceased donor care, lack of screening for CKD in a achievement will be assessed in relation transplants. A commenter stated that primary care setting, and lack of patient to home dialysis rates among non- they believe home dialysis can preserve education about ESRD and dialysis participants. As such, any system-level or enhance the quality of care for ESRD options before beneficiaries initiate limitations that affect home dialysis Beneficiaries while reducing Medicare dialysis, as beneficiaries who have rates for ETC Participants are also expenditures. Another commenter access to these services are more likely reflected in the ESRD facilities and stated that shifting dialysis provision to initiate dialysis at home. Commenters Managing Clinicians not participating in from in-center dialysis to home dialysis stated that many of these barriers to the Model that form the basis for the would have positive economic effects, home dialysis are outside of the control benchmarks. including decreasing costs for dialysis of Managing Clinicians and ESRD In response to the commenters’ providers, creating economies of scale facilities. concerns about certification for home dialysis supplies and logistics, Response: We thank the commenters requirements deterring ESRD facilities and increasing research and for their feedback. CMS recognizes that from operating home dialysis programs, development into new home dialysis there are a variety of barriers that we did not propose to waive Medicare technologies. prevent ESRD Beneficiaries from certification requirements as part of this Response: We thank the commenters choosing home dialysis at present. Model, in order to preserve patient for their feedback and support. If the ESRD facilities and Managing Clinicians health and safety. Additionally, the Model increases rates of home dialysis aggregation approach for this Model, in are the clinical experts in dialysis as intended, we will assess the impact which all ESRD facilities owned in provision in general, and in the clinical of increased rates of home dialysis on whole or in part by the same dialysis and non-clinical needs of individual quality of care, including—to the extent organization within a Selected ESRD Beneficiaries specifically. We possible—those particular aspects of Geographic Area are assessed as one therefore believe that ESRD facilities care quality identified by commenters. aggregation group with respect to their and Managing Clinicians are uniquely The evaluation plan for the Model is performance on the home dialysis rate, positioned to assist ESRD Beneficiaries discussed in section IV.C.11 of this final alleviates the need for individual ESRD rule. in overcoming these barriers, given their facilities to become certified to perform Comment: Multiple commenters close care relationship to and frequent home dialysis. expressed agreement with barriers to the interaction with ESRD Beneficiaries. Comment: Several commenters stated provision of home dialysis services as Therefore, we have designed the ETC that comparing U.S. rates of home previously identified in this final rule Model to test whether outcomes-based dialysis to other countries, particularly and in the proposed rule. Commenters payment adjustments for ESRD facilities other countries with very high home specifically identified barriers and Managing Clinicians can maintain dialysis rates, is inappropriate, because surrounding limited patient education or improve quality and reduce costs by those countries have different about and awareness of home dialysis, increasing rates of home dialysis demographic, socioeconomic, and and lack of familiarity and comfort with transplant waitlisting, and living donor health system factors that impact home prescribing home dialysis among transplants. The ETC Model is one piece dialysis utilization. Several commenters Managing Clinicians. Commenters also of the Advancing American Kidney stated that other countries that are more identified additional factors that may Health initiative, a larger HHS effort similar to the U.S. in demography, prevent beneficiaries from selecting focused on improving care for patients socioeconomic status, and health system home dialysis, including: clinical, with kidney disease.126 The payment structure have home dialysis rates closer mental, and social stability; inadequate adjustments in the ETC Model test one to that of the U.S. or unstable housing conditions; approach to addressing existing Response: We appreciate the socioeconomic factors; and patient disincentives to home dialysis and commenters’ concerns about comparing preference. Several commenters home dialysis rates in the U.S. to home identified aspects of the Medicare FFS 126 E.O. 13879 of July 10, 2019. dialysis rates in other countries. We

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acknowledge that there are differences discharged are re-hospitalized within 30 their beneficiaries in securing a between the U.S. and other countries days of being discharged.130 Among transplant. Access to kidney that may make direct comparisons transplant recipients, there are lower transplantation can be improved by challenging. We provided the rates of hospitalizations, emergency increasing referrals to the transplant comparison in the proposed and final department visits, and readmissions.131 waiting list, increasing rates of deceased rules for context but have designed the As discussed in the proposed rule, and living kidney donation, expanding Model specifically for the U.S. market, while comparisons between patients on the pools of potential donors and in particular the Medicare program. dialysis and those with functioning recipients, and reducing the likelihood transplants rely on observational data, that potentially viable organs are b. Kidney Transplants due to the ethical concerns with discarded.135 We noted in the proposed As we discussed in the proposed rule, conducting clinical trials, the data rule that we anticipated Managing a kidney transplant involves surgically nonetheless suggest better outcomes for Clinicians and ESRD facilities selected transplanting one healthy kidney from a ESRD patients that receive transplants. for participation in the ETC Model living or deceased donor. A kidney- Notwithstanding these outcomes, as would address these areas of pancreas transplant involves we discussed in the proposed rule, only improvement through various strategies simultaneously transplanting both a 29.6 percent of prevalent ESRD patients in order to improve their rates of kidney and a pancreas, for patients who in the U.S. had a functioning kidney transplantation. As we noted in the have kidney failure related to type 1 transplant and only 2.8 percent of proposed rule, these strategies could diabetes mellitus. While the kidney in a incident ESRD patients—meaning include educating beneficiaries about kidney transplant may come from a patients new to ESRD—received a pre- transplantation, coordinating care for living or deceased donor, a kidney emptive kidney transplant in 2016.132 A beneficiaries as they progress through transplant in conjunction with a pre-emptive transplant is a kidney the transplant waitlist process, and pancreas or other organ can only come transplant that occurs before the patient assisting beneficiaries and potential from a deceased donor. As noted in the requires dialysis. These rates are donors with issues surrounding living proposed rule, candidates for kidney substantially below those of other donation, including support for paired transplant undergo a rigorous evaluation developed nations. The U.S. was ranked donations and donor chains. In paired by a transplant center prior to 39th of 61 reporting countries in kidney donations and donor chains, willing placement on a waitlist, and once transplants per 1,000 dialysis patients in donors who are incompatible with their placed on the waitlist, potential 2016, with 39 transplants per 1,000 intended recipient can donate to other recipients must maintain active status dialysis patients in 2016.133 While the candidates on the transplant waitlist in on the waitlist. The United Network for relatively low rate of transplantation in return for a donation from another Organ Sharing (UNOS) maintains the the U.S. may partly reflect the high willing donor who is compatible with waitlist for and conducts matching of numbers of dialysis patients and their intended recipient.136 deceased donor organs. ESRD differences in the relative prevalence After increasing during the 1990s, the Beneficiaries already on dialysis and incidence of ESRD, as we noted in volume of simultaneous pancreas and continue to receive regular dialysis the proposed rule, there are other likely kidney transplants has either remained treatments while waiting for an contributing causes, such as differences stable or declined slightly since the appropriate organ. in health care systems, the early 2000s. As we noted in the As cited in the proposed rule, a infrastructure supporting proposed rule, the reason for this 134 systematic review of studies worldwide transplantation, and cultural factors. decline is not clear, but is likely to be found significantly lower mortality and As we discussed in the proposed rule, multifactorial, possibly including a risk of cardiovascular events associated the main barrier to kidney transplant is decrease in patients being placed on the the supply of available organs. Medicare with kidney transplantation compared waiting list for this procedure, more is undertaking regulatory efforts to with maintenance dialysis.127 stringent donor selection, and greater increase organ supply, discussed in the Additionally, this review found that scrutiny of transplant center proposed rule and in section IV.B.3.a of 137 beneficiaries who receive transplants outcomes. this final rule. Further, as discussed in As we discussed in the proposed rule, experience a better quality of life than the proposed rule, we believe there are under current Medicare payment those who receive treatment with a number of things ESRD facilities and systems, an ESRD Beneficiary receiving chronic dialysis.128 Managing Clinicians can do to assist a kidney transplant represents a loss of As we noted in the proposed rule, revenue to the ESRD facility and, to a per-beneficiary-per-year Medicare 130 United States Renal Data System. Annual Data lesser extent, the Managing Clinician. expenditures for beneficiaries receiving Report, 2018; Volume 2, Chapter 4: After a successful transplant occurs, the kidney or kidney-pancreas transplants Hospitalizations, Readmissions, Emergency Department Visits, and Observation Stays. Tables ESRD facility no longer has a care are often substantially lower than for relationship with the beneficiary, as the those on dialysis.129 The average F4–1, F4–8. 131 United States Renal Data System. Annual Data dialysis patient is admitted to the Report, 2018: Volume 2, Chapter 4: 135 Serur D, Bingaman A, Smith B. Kidney hospital nearly twice a year, often as a Hospitalizations, Readmissions, Emergency Transplantation 2017 Breaking Down Barriers and result of infection, and approximately Department Visits, and Observation Stays. Tables Building Bridges. American Society of Nephrology: 35.4 percent of dialysis patients who are F4.1, F4.8, and F4.14. Kidney News Online. 2017; 9(4): kidneynews.org/ 132 United States Renal Data System. Annual Data kidney-news/practice-pointers/kidney- Report, 2018; Volume 2. Chapter 1: Incidence, transplantation-2017-breaking-down-barriers-and- 127 Tonelli M, Weibe N, Knoll G, Bello A, Browne Prevalence, Patient Characteristics, and Treatment building-bridges. S. Jadhav D, Klarenbach S, Gill J. Systematic Modalities. https://www.usrds.org/2018/view/v2_ 136 Segev D, Gentry S, Warren D. Kidney Paired Review: Kidney Transplantation Compared with 01.aspx. Donation and Optimizing the Use of Live Donor Dialysis in Clinically Relevant Outcomes. American 133 United States Renal Data System. Annual Data Organs. JAMA. 2005;293(15):1883–1890. Journal of Transplantation. 2011; 11(10). doi: Report, 2018. Volume 2. Chapter 11. International doi:10.1001/jama.293.15.1883. https://doi.org/10.1111/j.1600-6143.2011.03686.x. Comparisons. Figure 11.16. 137 Redfield RR, Scalea JR, Odoricio JS. 128 Tonelli, M. et al. 2011. 134 United States Renal Data System. Annual Data Simultaneous pancreas and kidney transplantation: 129 United States Renal Data System.Annual Data Report, 2018: Volume 2. Chapter 11. International Current trends and future directions. Current Report, 2018. Volume 2. Chapter 9: Healthcare Comparisons. https://www.usrds.org/2018/view/v2_ Opinion in Organ Transplantation. 2015; 20(1): 94– expenditures for Persons with ESRD. Figure F9.8. 11.aspx. 102. Doi:10.1097/MOT.0000000000000146.

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beneficiary no longer requires rates described in section IV.B.1.a of undertaken other regulatory efforts to maintenance dialysis. While the this final rule. increase the supply of organs, including Managing Clinician may continue to Comment: Multiple commenters the proposed rule issued December 23, have a care relationship with the expressed agreement with the barriers to 2019 entitled ‘‘Medicare and Medicaid beneficiary post-transplant, payment for transplantation identified in the Programs; Organ Procurement physicians’ services related to proposed rule (also discussed earlier in Organizations Conditions for Coverage: maintaining the health of the this final rule). Commenters specifically Revisions to the Outcome Measure transplanted kidney is lower than the identified the limited supply of organs Requirements for Organ Procurement MCP for managing dialysis. Whereas a for transplantation as the key barrier to Organization[s]’’ (84 FR 70628), and the Managing Clinician sees a beneficiary transplantation. Several commenters proposed rule published December 20, on dialysis and bills for the MCP each stated that there is significant variation 2019 entitled ‘‘Removing Financial month, a post-transplant beneficiary nationally in the patient experience of Disincentives to Living Organ requires fewer visits per year, and these transplantation, including the supply of Donation’’ (84 FR 70139). The payment visits are of a lower intensity. As organs and transplant center practices. adjustments in the ETC Model test one described in greater detail in the A commenter stated that each transplant approach for addressing existing proposed rule and throughout this center sets its own guidelines for disincentives to transplantation in the section IV of this final rule, one of the transplant waitlisting, and that some current Medicare FFS payment system, aims of the ETC Model is to test whether centers exclude patients who do not including to create incentives to support new payment incentives would lead to have financial resources or health a beneficiary through the complexity of greater rates of kidney transplantation. insurance coverage beyond Medicare. A the transplant process. As described in commenter described factors that greater detail in section IV.C.1 of this The following is a summary of the patients have identified as limiting their comments received on the benefits of final rule, we are altering the PPA access to transplant waitlisting, calculation such that ETC Participant and barriers to transplantation and our including: The complexity, intensity, responses. performance will be assessed based on and difficulty of the waitlisting process; a transplant rate calculated as the sum Comment: Multiple commenters uncertainty and lack of social, financial, of the transplant waitlist rate and the expressed support for the premise that and medical support; cost; and fear of living donor transplant rate, rather than transplantation is the best treatment loss of Medicare coverage post- a transplant rate focused on the receipt option for most patients with ESRD. transplant. A commenter stated that lack of all kidney transplants including These commenters also stated that of access to primary care and early deceased donor transplants. We made research shows that transplantation is detection of kidney disease is associated this alteration to recognize the role that associated with better health outcomes, with lower likelihood of receiving a ETC Participants can currently play in better quality of life, and lower health transplant. getting patients on the transplant Response: We thank the commenters care expenditures. waitlist rate and in increasing the rate of for their feedback. CMS recognizes that Response: We thank the commenters living donor transplants described later there are a variety of barriers that on in the rule while allowing the ETC for their feedback and support. prevent ESRD Beneficiaries from Learning Collaborative and these other Comment: A commenter stated that receiving a transplant at present. As CMS and HHS rules (if finalized) time rates of transplantation in the U.S. are noted previously in this final rule, we to take effect and to increase the supply not directly comparable to rates of believe that ESRD facilities and of available deceased donor organs. transplantation in other countries due to Managing Clinicians are uniquely However, as described in greater detail different population characteristics. positioned to assist beneficiaries in overcoming barriers to transplantation, in section IV.C.5.c.(2) of this final rule, Response: We thank the commenter it is also our intent to observe the for this feedback. As stated in the for both deceased donor transplantation and living donor transplantation, given supply of deceased donor organs proposed rule and earlier in this final available for transplantation. Any rule, we acknowledge that, in addition their close care relationship to and frequent interaction with ESRD change from holding ETC Participants to variations in the relative prevalence accountable for the rate of all kidney and incidence of ESRD, there are other Beneficiaries. Therefore, we have designed the ETC Model to test whether transplants including deceased donor likely contributing causes to the transplantation, rather than the rate of relatively low rate of transplantation in outcomes-based payment adjustments for ESRD facilities and Managing kidney transplant waitlisting and living the U.S. relative to other countries, such donor transplantation would be as differences in health care systems, Clinicians can maintain or improve quality and reduce costs by increasing proposed through notice and comment the infrastructure supporting rulemaking in the future. transplantation, and cultural factors.138 rates of home dialysis and In the final rule, we are clarifying that As such, while we included information transplantation. As also noted when referencing kidney transplants in about transplant rates in other countries previously in this final rule, the ETC this final rule and the ETC Model for comparison, we did not propose to Model is one piece of a larger HHS effort regulations, CMS is including any base the design of the Model’s focused on improving care for patients kidney transplant, alone or in transplant component on transplant with kidney disease. In particular, we conjunction with any other organ, not rates in other countries. We believe that recognize that other transplant just a kidney transplant or kidney- the transplant rate in the U.S. can be providers, including transplant centers and organ procurement organizations pancreas transplant. As discussed in higher than it is now, and to that end (OPOs) are central to the supply and use more detail in section IV.C.5 of this final are testing this Model in conjunction of deceased donor organs. As such, we rule, we received a comment that urged with other efforts to increase transplant are implementing the ETC Learning CMS to include in the ETC Model Collaborative, described in section kidney transplants in conjunction with 138 United States Renal Data System. Annual Data Report, 2018: Volume 2. Chapter 11. International IV.C.12 of this final rule, to increase the any other organ, in addition to the Comparisons. https://www.usrds.org/2018/view/v2_ supply and use of deceased donor kidney transplants and kidney-pancreas 11.aspx. organs. CMS and HHS have also transplants referenced in the proposed

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rule. By specifying in the proposed rule Clinicians managing low volumes of ETC Model would harm the KCC Model that we were including kidney and adult ESRD Medicare beneficiaries. because the national impact of the ETC kidney-pancreas transplants under the Under our proposal, one or both of the Model would deter participation in and Model, it was not our intent to imply payment adjustments under the ETC the evaluation of the KCC Model. that we were excluding kidney Model would apply to payments on Response: We thank the commenters transplants in conjunction with any claims for dialysis and certain dialysis- for their feedback and support of the other organ. Therefore, as discussed in related services with through dates from Model’s goals. In terms of the section IV.C.5 of this final rule, we are January 1, 2020 through June 30, 2026, commenters’ concerns that the Model clarifying as part of the final definition with the goal of reducing Medicare does not address some or all of the key of kidney transplant that the ETC Model spending, preserving or enhancing barriers to home dialysis and includes kidney transplants that occur quality of care for beneficiaries, and transplantation and does not sufficiently alone or in conjunction with any other increasing beneficiary choice regarding incentivize supporting patient choice, organ. ESRD treatment modality. this Model is one piece of the larger The following is a summary of the HHS effort to improve care for c. Addressing Care Deficits Through the comments received on addressing care beneficiaries with kidney disease, ETC Model deficits through the ETC Model, and our which also includes the KCC Model. Considering patient and clinician responses. While the ETC Model focuses primarily support for home dialysis and kidney Comment: Multiple commenters on modality selection, other parts of the transplant for ESRD patients, along with expressed support for the goals of the HHS effort focus more directly on other evidence that use of these treatment proposed Model. Commenters expressed ways to improve care for beneficiaries modalities could be increased with support for increasing rates of home with kidney disease, including education, we proposed to implement dialysis and transplantation, on the education and prevention, care the ETC Model to test whether adjusting grounds that these alternative renal coordination, organ supply, and Medicare payments to ESRD facilities replacement modalities are better for technological innovation. We agree that under the ESRD PPS and to Managing patients with ESRD than in-center supporting patient choice in modality Clinicians under the PFS would dialysis. Several commenters expressed selection is vital, and we believe the increase rates of home dialysis, both support for the proposed Model’s ETC Model will support providers and HHD and PD, and kidney and kidney- approach to increasing home dialysis suppliers in their ability to assist pancreas transplantation. and transplantation through payment beneficiaries choosing renal We proposed that the ETC Model adjustments, as well as the proposed replacement modalities other than in- would include two types of payment Model’s geographic scope and its center dialysis. We address the adjustments: The Home Dialysis mandatory design. These commenters commenters’ specific comments about Payment Adjustment (HDPA) and the also stated that the proposed Model had the interaction with the KCC Model in Performance Payment Adjustment the potential to: Create system-wide section IV.C.6 of this final rule, and in (PPA). The HDPA would be a positive change; support technological other sections of this final rule where payment adjustment on home dialysis innovation; and facilitate research into particular policies are discussed. and home dialysis-related claims during factors that impact the provision of Comment: Multiple commenters the initial three years of the Model, to dialysis, clinical outcomes related to stated that they supported the goals of provide an up-front incentive for ETC dialysis modality selection, and patient the proposed ETC Model but opposed Participants to provide additional outcomes. the Model itself. Several commenters support to beneficiaries choosing to Response: We thank the commenters stated that the proposed Model had dialyze at home. The PPA would be a for their feedback and support of the significant methodological limitations positive or negative payment Model’s goals. that would lead to unintended adjustment, which would increase over Comment: Multiple commenters consequences and adverse patient time, on dialysis and dialysis-related stated that they supported the goals of outcomes. A commenter stated that the claims, both home and in-center, based the proposed Model, but expressed proposed Model would amount to a on the ETC Participant’s home dialysis reservations about aspects of the payment reduction for all dialysis rates and transplant rates during a Model’s design. Several commenters providers. Several commenters stated Measurement Year in comparison to stated that any payment incentives for that, as proposed, methodological flaws achievement and improvement providers and suppliers need to be with the Model’s design would prevent benchmarks, with the aim of increasing balanced against patient preferences and participants from being successful in the the percent of ESRD Beneficiaries either minimizing or avoiding unintended Model. In particular, a few commenters having received a kidney transplant or consequences. Several commenters stated that small dialysis organizations receiving home dialysis over the course stated that the ETC Model, as proposed, and rural ESRD facilities would be of the ETC Model. We proposed that the would not address some or all of the key harmed due to the financial risk in the magnitude of the HDPA would decrease barriers to home dialysis and Model. Several commenters stated that as the magnitude of the PPA increases, transplantation, including that the rather than implement the ETC Model, to shift from a process-based incentive Model, as proposed, had an insufficient CMS should focus on implementing approach (the HDPA) to an outcomes- focus on prevention and patient voluntary models that incentivize based incentive approach (the PPA). education, organ availability, and the dialysis providers to collaborate around The proposed payment adjustments supply of trained home dialysis staff care coordination, such as the CEC under the ETC Model would apply to all including home dialysis nurses, and did Model. A commenter stated that, as the Medicare-certified ESRD facilities, and not adequately take into account the current organ allocation system may Managing Clinicians enrolled in unique structure of the dialysis market. change, it is inappropriate to test a Medicare located within Selected Several commenters stated that the model around transplantation at this Geographic Areas. While we proposed proposed Model would not sufficiently time. to apply the HDPA to all ETC incentivize ETC Participants to take Response: We thank the commenters Participants, the PPA would not apply patient choice into account. Several for their feedback and support of the to certain ESRD facilities and Managing commenters expressed concern that the Model’s goals. We address commenters’

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specific comments about supplies. Section 1881(c)(6) of the Act in-center patients. (73 FR 20369, 20409, methodological concerns, the impact of states: It is the intent of the Congress April 15, 2008). the Model on small and rural ESRD that the maximum practical number of As we also noted in the proposed facilities, and the organ allocation patients who are medically, socially, rule, on January 1, 2011, CMS system in later sections of this final rule and psychologically suitable candidates implemented the ESRD PPS, a case-mix where particular policies are discussed. for home dialysis or transplantation adjusted, bundled PPS for renal dialysis Comment: Several commenters stated should be so treated. This provision also services furnished by ESRD facilities as that supporting patient choice and directs the Secretary of HHS to consult required by section 1881(b)(14) of the informed decision-making are vital, and with appropriate professional and Act, as added by section 153(b) of should be the focus of the proposed network organizations and consider MIPPA. The ESRD PPS is discussed in Model. available evidence relating to detail in the following section. Response: We thank the commenters developments in research, treatment b. Current Medicare Coverage of and for their feedback, and we agree that methods, and technology for home Payment for ESRD Services supporting patient choice in modality dialysis and transplantation. selection is vital. We believe this Model Prior to 2011 and the implementation The Medicare program covers a range will support beneficiaries’ ability to of the ESRD PPS, Medicare had a of services and items associated with choose renal replacement modalities composite payment system for the costs ESRD treatment. Medicare Part A other than in-center HD. incurred by ESRD facilities furnishing generally includes coverage of inpatient Comment: Many commenters outpatient maintenance dialysis, dialysis for patients admitted to a recommended additional or alternative including some routinely provided hospital or skilled nursing facility for approaches, outside of the ETC Model, drugs, laboratory tests, and supplies, special care, as well as inpatient that CMS could take to improve quality whether the services were furnished in services for covered kidney transplants. of care for Medicare beneficiaries with a facility or at home. (For a discussion Medicare Part B generally includes kidney disease. of the composite payment system, coverage of renal dialysis services Response: We thank commenters for please see 75 FR 49032). Under this furnished by Medicare-certified their feedback; however, these methodology, prior to 2009, CMS outpatient facilities, including certain suggestions did not address the ETC differentiated between hospital-based dialysis treatment supplies and Model and therefore are out of scope for and independent facilities for purposes medications, home dialysis services, this rulemaking. We may consider these of setting the payment rates. (Effective support and equipment, and doctor’s comments in developing future policies January 1, 2009, CMS discontinued the services during a kidney transplant. related to beneficiaries with kidney policy of separate payment rates based Costs for medical care for a kidney disease. on this distinction, 75 FR 49034). donor are covered under either Part A However, the same rate applied or B, depending on the service. To date, 2. The Medicare ESRD Program regardless of whether the dialysis was Medicare Part C has been available to In the proposed rule and in this furnished in a facility or at a ESRD Beneficiaries only in limited section of the final rule, we describe beneficiary’s home (75 FR 49058). The circumstances, such as when an current Medicare payment rules and system was relatively comprehensive individual already was enrolled in a how they may create both positive and with respect to the renal dialysis Medicare Advantage (MA) plan at the negative incentives for the provision of services included as part of the time of ESRD diagnosis; however, as home dialysis services and kidney composite payment, but over time a required under section 17006 of the 21st transplants. substantial portion of expenditures for Century Cures Act, ESRD Beneficiaries will be allowed to enroll in MA plans a. History of the Medicare ESRD renal dialysis services such as drugs and biologicals were not included under the starting with 2021. Medicare Part D Program composite payment and paid separately generally provides coverage for Section 299I of the Social Security in accordance with the respective fee outpatient prescription drugs not Amendments of 1972 (Pub. L. 92–603) schedules or other payment covered under Part B, including certain extended Medicare coverage to methodologies (75 FR 49032). With the renal dialysis drugs with only an oral individuals regardless of age who have enactment of the Medicare form of administration (oral-only drugs), permanent kidney failure, or ESRD, Improvements for Patients and and prescription medications for related requiring either dialysis or kidney Providers Act of 2008 (MIPPA) (Pub. L. conditions. transplantation to sustain life, and who 110–275), the Secretary was required to (1) The ESRD PPS Under Medicare meet certain other eligibility implement a payment system under Part B requirements. Individuals who become which a single payment is made for eligible for Medicare on the basis of renal dialysis services in lieu of any As we discussed in the proposed rule, ESRD are eligible for all Medicare- other payment. under the ESRD PPS, a single per covered items and services, not just As we described in the proposed rule, treatment payment is made to an ESRD those related to ESRD. Subsequently, in 2008, CMS issued a final rule entitled facility for all of the renal dialysis the ESRD Amendments of 1978 (Pub. L. ‘‘Medicare and Medicaid Programs; services and items defined in section 95–292) amended Title XVIII of the Act Conditions for Coverage for End-Stage 1881(b)(14)(B) of the Act and furnished by adding section 1881. Renal Disease Facilities,’’ which was the to beneficiaries for the treatment of Section 1881 of the Act establishes first comprehensive revision since the ESRD in a facility or in a patient’s home. Medicare payment for services outset of the Medicare ESRD program in The ESRD PPS includes patient-level furnished to individuals who have been the 1970s. The Conditions for Coverage adjustments for case mix, facility-level determined to have ESRD, including (CfC) established by this final rule adjustments for wage levels, low- payments for self-care home dialysis include separate, detailed provisions volume facilities and rural facilities, support services furnished by a provider applicable to home dialysis services, and, when applicable, a training add-on of services or renal dialysis facility, setting substantive standards for for home and self-dialysis modalities, an home dialysis supplies and equipment, treatment at home to ensure that the additional payment for high cost and institutional dialysis services and quality of care is equivalent to that for outliers due to unusual variations in the

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type or amount of medically necessary requires the Secretary to select provide this service, and also the care, a transitional drug add-on payment measures, establish performance limitation of eligibility to the specific adjustment (TDAPA), and a transitional standards that apply to the measures, category of Stage 4 CKD patients. As we add-on payment adjustment for new and and develop a methodology for noted in the proposed rule, these innovative equipment and supplies assessing the total performance for each restrictions are specified in section (TPNIES).139 Under section renal dialysis facility based on the 1861(ggg)(1) and (2) of the Act. A 1881(b)(14)(F) of the Act, the ESRD PPS performance standards established with ‘‘qualified person’’ is a physician, payment amounts are increased respect to the measures for a physician assistant, or nurse annually by an ESRD market basket performance period. CMS uses notice practitioner, or a provider of services increase factor, reduced by the and comment rulemaking to make located in a rural area. GAO cited productivity adjustment described in substantive updates to the ESRD PPS literature emphasizing the importance section 1886(b)(3)(B)(xi)(II) of the Act. and ESRD QIP program requirements. of pre-dialysis education in helping As we noted in the proposed rule, in patients to make informed treatment (2) The MCP implementing the ESRD PPS, we have decisions, and indicating that patients sought to create incentives for providers As we discussed in the proposed rule, who have received such education and suppliers to offer home dialysis Medicare pays for routine professional might be more likely to choose home instead of just dialysis at a facility. In services relating to dialysis care directly dialysis. the CY 2011 ESRD PPS final rule, we to a billing physician or non-physician noted that in determining payment practitioner. When Medicare pays the c. Impacts of Medicare Payment Rules under the ESRD PPS, we took into physician or practitioner separately for on Home Dialysis account all costs necessary to furnish routine dialysis-related physicians’ As we discussed in the proposed rule, home dialysis treatments including services furnished to a dialysis patient, in the CY 2011 ESRD PPS final rule, we staff, supplies, and equipment. In that the payment is made under the acknowledged concerns from rule, we described that Medicare would Medicare physician fee schedule using commenters that the proposed ESRD continue to pay, on a per treatment the MCP method as specified in 42 CFR PPS might contribute to decreasing rates basis, the same base rate for both in- 414.314. The per-beneficiary per-month of home dialysis. In particular, facility and home dialysis, as well as for MCP is for all routine physicians’ commenters stated that the single all dialysis treatment modalities services related to the patient’s renal payment method would require ESRD furnished by an ESRD facility (HD and condition. Whereas the MCP for patients facilities to bear the supply and the various forms of PD) (75 FR 49057, dialyzing in-center varies based on the equipment costs associated with home 49059, 49064). The CY 2011 ESRD PPS number of in-person visits the physician dialysis modalities, and thus make them final rule also finalized a wage-adjusted has with the patient during the month, less economically feasible. We noted in add-on per treatment adjustment for the MCP for patients dialyzing at home response that while home dialysis home and self-dialysis training under 42 is the same regardless of the number of suppliers may not achieve the same CFR 413.235(c), as CMS recognized that in-person visits.140 economies of scale as ESRD facilities, the ESRD PPS base rate alone does not (3) The Kidney Disease Education suppliers would remain able to provide account for the staffing costs associated Benefit equipment and supplies to multiple with one-on-one focused home dialysis ESRD facilities and be able to negotiate training treatments furnished by a As we discussed in the proposed rule, competitive prices with ESRD registered nurse (75 FR 49064). CMS in addition to establishing the ESRD equipment and supply manufacturers noted, however, that because the costs PPS, the MIPPA, in section 152(b), (75 FR 49060). Nevertheless, we stated associated with the onset of dialysis amended section 1861(s)(2) of the Act that we would monitor utilization of adjustment and the training add-on by adding a new subparagraph (EE) home dialysis under the ESRD PPS (75 adjustment overlap, ESRD facilities ‘‘kidney disease education services’’ as FR 49057, 49060). would not receive the home dialysis a Medicare-covered benefit under Part B As we further discussed in the training adjustment in addition to the for beneficiaries with Stage 4 CKD. proposed rule, a May 2015 report from add-on payment under the ESRD PPS Medicare currently covers up to 6 1- GAO examined the incentives for home for the first 4 months of dialysis for a hour sessions of KDE services, dialysis associated with Medicare Medicare patient (75 FR 49063, 49094). addressing the choice of treatment (such payments to ESRD facilities and As we noted in the proposed rule, as in-center HD, home dialysis, or physicians. Citing the USRDS, GAO ESRD PPS payment requirements are set kidney transplant) and the management found a decrease in the percentage of forth in 42 CFR part 413, subpart H. of comorbidities, among other topics (74 home dialysis patients as a percentage Since the implementation of the ESRD FR 61737, 61894). of all dialysis patients between 1988 However, utilization of KDE services PPS, CMS has published annual rules to and 2008, but then a slight increase to has been low. As we described in the make routine updates, policy changes, 11 percent in 2012.142 According to proposed rule, citing the USRDS, GAO and clarifications. Payment to ESRD GAO, the more recent increase in use of reported that less than 2 percent of facilities under the ESRD PPS for a home dialysis was also reflected in CMS eligible Medicare beneficiaries used the calendar year might also be reduced by data for adult Medicare dialysis KDE benefit in 2010 and 2011, the first up to two percent based on their patients, showing an increase from 8 2 years it was available, and that use of performance under the ESRD QIP, percent using home dialysis in January the benefit has decreased since then.141 which is authorized by section 1881(h) 2010 to about 10 percent as of March According to GAO, stakeholders have of the Act. Section 1881(h) of the Act attributed this low usage to the statutory 2015. Although this increase was generally restrictions on which practitioners can 139 After we published the proposed rule to concurrent with the phase-in of the implement the ETC Model, CMS established the ESRD PPS, the GAO report identified TPNIES under the ESRD PPS as part of the CY 2020 140 Medicare Claims Processing Manual, Chapter ESRD PPS final rule (84 FR 60648). We discuss the 8, 140; https://www.cms.gov/Regulations-and- factors that might undermine incentives implications of this change for the ETC Model Guidance/Manuals/Downloads/clm104.c08.pdf. payment adjustments in sections IV.C.4.b, and 141 United States Government Accountability 142 United States Government Accountability IV.C.5.e(1) of this final rule. Office, 2015. Office, 2015.

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to encourage home dialysis. According 3. CMS Efforts To Support Modality End-Stage Renal Disease Quality to interviews with stakeholders, Choice Incentive Program, Durable Medical facilities’ costs for increasing provision While CMS has taken steps in the past Equipment, Prosthetics, Orthotics and of in-center HD may be lower than for to support modality choice, the deficits Supplies (DMEPOS) Competitive either HHD or PD. Although the average in care previously described—low rates Bidding Program (CBP) and Fee cost of an in-center HD treatment is of home dialysis and kidney Schedule Amounts, and Technical typically higher than the average cost of transplantation—remain. We noted in Amendments To Correct Existing a PD treatment, ESRD facilities may be the proposed rule our belief that the Regulations Related to the CBP for able to add an in-center patient without proposed ETC Model is consistent with Certain DMEPOS’’ (CY 2019 ESRD PPS final rule) (83 FR 56922). In that final incurring the cost of an additional several different recent actions to dialysis machine because each machine rule, CMS adopted a new measure for support modality choice for ESRD can be used by 6 to 8 patients. In the ESRD Quality Incentive Program Beneficiaries, which are described in contrast, when adding a home dialysis (QIP) beginning with PY 2022, entitled the proposed rule as well as this final patient, facilities generally incur costs the Percentage of Prevalent Patients rule. for additional equipment specific to Waitlisted (PPPW) measure, and placed individual patients.143 a. Regulatory Efforts that measure in the Care Coordination Similarly, GAO received comments As discussed in the proposed rule, on domain for purposes of performance from physicians and physician September 20, 2018, we published in scoring under the program. We stated organizations that Medicare payment the Federal Register a proposed rule that the adoption of this measure may lead to a disincentive to prescribe entitled ‘‘Medicare and Medicaid reflects CMS’s belief that ESRD facilities home dialysis, because management of Programs; Regulatory Provisions to should make better efforts to ensure that a home dialysis patient often occurs in Promote Program Efficiency, their patients are appropriately a private setting and tends to be more waitlisted for transplants (83 FR 57006). Transparency, and Burden Reduction’’ comprehensive, while visits to multiple We also noted in the proposed rule that (83 FR 47686). This rule was finalized in-center patients may be possible in the the proposed ETC Model would provide without change on September 30, 2019 same period of time. The GAO report greater incentives for ESRD facilities (84 FR 51732). This final rule, among noted, on the other hand, that monthly and Managing Clinicians participating other things, removed the requirements physician payments for certain patients in the Model to assist ESRD at 42 CFR 482.82 that required under 65 who undergo home dialysis Beneficiaries with navigating the transplant centers to submit clinical training may begin the first month, transplant process, including experience, outcomes, and other data in instead of the fourth, of dialysis, which coordinating care to address clinical and order to obtain Medicare re-approval. may provide physicians with an non-clinical factors that impact incentive to prescribe home dialysis. In CMS removed these requirements in eligibility for wait-listing and addition, the GAO report stated that order to address the unintended transplantation. Medicare makes a one-time payment for consequences that occurred as a result each patient who has completed home of the Medicare re-approval b. Alternative Payment Models dialysis training under the physician’s requirements, which have resulted in Recognizing the importance of supervision.144 transplant programs potentially ensuring quality coordinated care to The GAO report concluded that avoiding performing transplant beneficiaries with ESRD, in 2015, CMS interviews with stakeholders indicated procedures on certain patients and began testing the Comprehensive ESRD potential for further growth, noting that many organs with perceived risk factors Care (CEC) Model. As we noted in the the number and percentage of patients going unused out of fear of being proposed rule, the CEC Model is an choosing home dialysis had increased in penalized for outcomes that are non- accountable care model in which the recent years. The report stated that compliant with § 482.82. Although CMS dialysis facilities, nephrologists, and Medicare payments to facilities and removed certain requirements at other health care providers join together physicians would need to be consistent § 482.82, CMS emphasized that to form ESRD Seamless Care with the goal of encouraging home transplant programs should focus on Organizations (ESCOs) that are dialysis when appropriate. A specific maintaining high standards that protect responsible for the cost and quality of recommendation was to examine patient health and safety and produce care for aligned beneficiaries. Although Medicare policies regarding monthly positive outcomes for transplant there are no specific incentives under Medicare payments to physicians and recipients. As we noted in this final the CEC Model relating to home revise them if necessary to encourage rule, CMS will also do complaint dialysis, CMS evaluated whether total physicians to prescribe home dialysis investigations based on public or cost of care incentives caused an for patients for whom it is confidential reports about outcomes or increase in the rate of home dialysis, as appropriate.145 adverse events. These efforts, and the would be predicted by some of the As discussed in the proposed rule, in survey of the other Conditions of literature, during the first two years of the CY 2017 ESRD PPS final rule, CMS Participation, will provide sufficient the CEC Model. To date, the evaluation finalized an increase to the home and oversight to ensure that transplant has not shown any statistically self-dialysis training add-on payment programs will continue to achieve and significant impact on the rates of home adjustment (81 FR 77856), to provide an maintain high standards of care. (84 FR dialysis among CEC Model increase in payment to ESRD facilities 51749). participants.146 Although the evaluation for training beneficiaries to dialyze at In addition, as we discussed in the results available for the CEC Model thus home. proposed rule, on November 14, 2018, far are limited, as we noted in the CMS published in the Federal Register proposed rule, based on these 143 United States Government Accountability a final rule entitled ‘‘Medicare Program; Office, 2015. End-Stage Renal Disease Prospective 146 Marrufo G, et al. Comprehensive End-Stage 144 United States Government Accountability Payment System, Payment for Renal Renal Disease Care (CEC) Model: Performance Year Office, 2015. 2 Annual Evaluation Report. CMS Innovation 145 United States Government Accountability Dialysis Services Furnished to Center. September 2019; innovation.cms.gov/Files/ Office, 2015. Individuals With Acute Kidney Injury, reports/cec-annrpt-py2.pdf.

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preliminary findings CMS believes that ending on June 30, 2026. We also vascular access providers; securing more targeted, system-wide incentives considered an alternate start date of supplies necessary to operate and may be necessary to encourage modality April 1, 2020, to allow more time to maintain a home dialysis program; choices and that the agency must prepare for Model implementation. We training of clinical staff, particularly provide explicit incentives in order to noted in the proposed rule that, if the home dialysis nurses; development of affect behavior changes by providers ETC Model were to begin April 1, 2020, new health information and data and suppliers. all intervals within the timelines systems to track and manage patients; On July 10, 2019, CMS announced the outlined in the proposed rule, including and making decisions about Kidney Care Choices (KCC) Model the periods of time for which claims participating in other CMS models and (formerly the Comprehensive Kidney would be subject to adjustment by the programs. Commenters also Care (CKC) Model). The KCC Model HDPA and the Measurement Years and recommended delaying the start date to builds on the existing CEC Model, and Performance Payment Adjustment allow CMS to resolve outstanding includes incentives for coordinating Periods used for purposes of applying concerns from the stakeholder care for aligned beneficiaries with CKD the PPA, would remain the same length, community, and to assess the efficacy of or ESRD and for reducing the total cost but start and end dates would be the model design. Several commenters of care for these beneficiaries, as well as adjusted to occur three months later. suggested that CMS delay the start date providing financial incentives for We also included in the proposed rule to no sooner than April 1, 2020, the successful transplants. As we noted in the following proposals for the Model: alternative start date included in the the proposed rule, we view the KCC (a) The method for selecting ESRD proposed rule. Several other Model as complementary to the ETC facilities and Managing Clinicians for commenters suggested a longer delay, Model, as both models incentivize a participation; (b) the schedule and including suggestions of July 1, 2020, greater focus on kidney transplants. We methodologies for payment adjustments October 1, 2020, and January 1, 2021. proposed that ESRD facilities and under the Model, and waivers of Several commenters suggested an Managing Clinicians may participate in Medicare payment requirements indefinite delay, such that the Model both models, as discussed in the necessary solely to test these would not begin until CMS further proposed rule and section IV.C.6 of this methodologies under the Model; (c) the consulted with stakeholders to resolve final rule. performance assessment methodology their concerns, including through a for ETC Participants, including the second round of notice and comment C. Provisions of the Proposed Regulation proposed methodologies for beneficiary rulemaking. A commenter suggested 1. Proposal To Implement the ETC attribution, benchmarking and scoring, that the Model be delayed until Model and calculating the Modality potential changes to the organ allocation Performance Score; (d) monitoring and system are resolved. In this section IV of the final rule, we evaluation, including quality measure Response: We appreciate the feedback discuss the policies that we proposed reporting; and (e) overlap with other from the commenters. After reviewing for the ETC Model, including model- CMS models and programs. the concerns raised in the comments specific definitions and the general We proposed to codify the definitions received, we agree that implementing framework for implementation of the and policies of the ETC Model at the ETC Model on January 1, 2020 ETC Model. The payment adjustments subpart C of part 512 of 42 CFR would not allow ETC Participants for the proposed ETC Model were (proposed §§ 512.300 through 512.397). sufficient time to prepare for successful designed to support increased We discuss the proposed definitions in participation in the Model. We utilization of home dialysis modalities section IV.C.2 of this final rule and each appreciate the feedback from the and kidney and kidney-pancreas of the proposed regulatory provisions commenters about alternative start dates transplants that may, according to the under the applicable subject area later. for the Model that would allow ETC literature described earlier in this Section II of this final rule provides that Participants sufficient time to prepare section IV of the rule, be subject to the general provisions codified at for the Model. We had intended to delay barriers. Specifically, with regard to §§ 512.100 through 512.180 apply to the ETC Model implementation date home dialysis, we acknowledged in the both the ETC Model and the RO Model until July 1, 2020, as had been proposed rule the possible need for described in section III of this rule. recommended by some of the ESRD facilities to invest in new systems The following is a summary of the commenters, but as we were completing that ensure that appropriate equipment comments received on the proposal to this final rule, the U.S. began and supplies are available in an implement the Model, including the responding to an outbreak of respiratory economical manner to support greater proposed start date and duration of the disease caused by a novel coronavirus, utilization by beneficiaries. We also Model, and our responses. referred to as ‘‘coronavirus disease recognized in the proposed rule that Comment: Many commenters opposed 2019’’ (COVID–19), which created a dialysis providers, nephrologists, and starting the model on January 1, 2020. serious public health threat greatly other clinicians would need to enhance Commenters stated that January 1, 2020 impacting the U.S. health care system. education and training, both for patients was too soon, and would not provide The Secretary of the Department of and professionals, that there are barriers ETC Participants sufficient advance Health and Human Services, Alex M. to patients choosing and accepting notice to prepare for successful Azar II, declared a Public Health home dialysis modalities, and that the participation in the Model and begin Emergency (PHE) on January 31, 2020, appropriateness of home dialysis as a working to address barriers to home retroactively effective from January 27, treatment option varies among patients dialysis and transplantation. In 2020, to aid the nation’s healthcare according to demographic and clinical particular, commenters pointed to community in responding to the characteristics, as well as personal specific areas in which ETC Participants COVID–19 pandemic. On July 23, 2020, choice. would need time to prepare, including: Secretary Azar renewed, effective July We proposed that the duration of the Design and implementation of new care 25, 2020, the determination that a PHE payment adjustments under the ETC processes; development of new exists. Model would be 6 years and 6 months, relationships with other care providers, In light of this unprecedented PHE, beginning on January 1, 2020, and particularly transplant providers and which continues to strain health care

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resources, as well as our understanding (if finalized), and we do not believe that implementation of the payment that ETC Participants may have limited any further delays are necessary. As adjustments to ESRD facilities based on capacity to meet the ETC Model discussed in section IV.C.5.c.(2) of this dialysis organization type, as a requirements in 2020, we are delaying final rule, it is our intent to observe the commenter suggested, as this approach implementation until January 1, 2021 to supply of deceased donor organs could unfairly advantage ESRD facilities ensure that participation in the ETC available for transplantation. owned by certain types of dialysis Model does not further strain the ETC Comment: Several commenters organizations over others. Participants’ capacity, potentially suggested that the Model have a Comment: A few commenters hindering the delivery of safe and staggered implementation, with some recommended that CMS shorten the efficient dialysis care. We believe this components of the Model beginning duration of the Model test to 3 years, delayed implementation will provide right away and other components with two optional extension years. ETC Participants with sufficient time to phasing in over the duration of the Commenters stated that this approach prepare for participation in the Model Model. Several commenters suggested would allow for a more limited test of and adhere to Model requirements. using a ‘‘Year 0’’ approach, in which the Model, and would facilitate Since the Model will begin on January ETC Participants would be in the Model extension of the Model if the Model 1, 2021, rather than January 1, 2020 for one year before payment adjustments appears to be achieving the intended (that is, 12 months later than proposed), begin. Similarly, several commenters goals during the initial 3 years. all time intervals outlined in the suggested that the downward payment Additionally, commenters suggested proposed rule, including the periods of adjustments in the PPA be delayed for that the initial years of the Model be time for which claims are adjusted for some amount of time, either until limited to a smaller portion of the the HDPA and Measurement Years and Measurement Year (MY) 3 or MY4, to country, such as 10 percent, and that Performance Payment Adjustment give ETC Participants more time to CMS increase the size of the Model in Periods for the purposes of applying the implement changes before they would future years. PPA, will remain the same in length, but be subject to downside financial risk, Response: As discussed in the will begin and end 12 months later than and to allow other changes to the proposed rule and in section IV.C.3.a of proposed. For detailed descriptions of transplant system time to take effect. A this final rule, the geographic scope of these time periods, see sections IV.C.5.d commenter suggested that downward the Model is determined based on the (HDPA) and IV.C.5.a (MYs and PPA payment adjustments should begin in scope of participation necessary to Periods) of this final rule. Also, as this 2021 for large dialysis organizations detect a statistically meaningful effect. final rule was published to the Federal (LDOs) and in 2022 for all other dialysis We do not anticipate that we would be Register in September, 2020, ETC organizations. able to determine whether the Model is Participants have more than 90 days to Response: We do not believe it is achieving its goals after three years, prepare to participate in the Model, necessary to phase-in our particularly as we are limiting the which we believe is sufficient. implementation of the Model, including Model to a smaller portion of the In response to the commenters’ the onset of downward payment country than originally proposed, such recommendations that we delay adjustments. The payment adjustments that we could decide to extend the implementation of the ETC Model until under the Model already begin with the Model at that time. we have gone through another round of HDPA, which is an upward payment Comment: Several commenters stated rulemaking, we have made certain adjustment only. The Model will be that CMS should conduct subsequent changes to the policies we proposed for ongoing for 1 year and 6 months before rulemaking through the duration of the the Model in response to the comments the PPA begins, functionally phasing-in Model to adapt the Model based on we received, as discussed in subsequent the Model’s downward payment observations made during the operation sections of this final rule, and we do not adjustment. As discussed in section of the Model. believe that it is necessary to conduct an IV.C.3.a of this final rule, the size of the Response: We agree that if it becomes additional round of notice and comment Model is determined based on the apparent that changes to the Model are rulemaking before finalizing the rule necessary participation and duration to needed during the Model’s and implementing the ETC Model. With detect a statistically meaningful effect. If implementation, any potential changes respect to comments recommending that we were to further phase-in the to the ETC Model provisions would be CMS delay implementation of the implementation of the downward made through subsequent notice and Model until changes to the transplant payment adjustments, we would not comment rulemaking. As discussed in system have had time to take effect, as have sufficient duration to evaluate the section II.J of this final rule, we note discussed in section IV.C.5.c.(2) of this effectiveness of the payment that section 1115A(b)(3)(B) of the Act final rule, we are altering the MPS adjustments at achieving the Model’s requires CMS to modify or terminate the calculation such that ETC Participant goals. While we appreciate the design or implementation of a model performance will be assessed based on commenters’ recommendation that CMS test under certain circumstances. a transplant rate calculated as the sum adopt a ‘‘Year 0’’ approach, and note Comment: Several commenters of the transplant waitlist rate and the that CMS has taken this approach in recommended that CMS separate the living donor transplant rather than a other models, in the case of the ETC ETC Model into two separate payment transplant rate focused on all kidney Model a ‘‘Year 0’’ would amount to models, one focused on home dialysis transplants including deceased donor nothing more than a delayed and one focused on kidney transplants. We made this alteration to implementation. As discussed earlier in transplantation. Commenters stated that recognize the role that ETC Participants this section IV.C.1 of this final rule, we this approach would account for can currently play in getting patients on believe that delaying the differences in the barriers to home the transplant waitlist rate and in implementation of this Model to January dialysis and transplantation and the increasing the rate of donor transplants 1, 2021, is sufficient to address the different incentives needed to overcome while allowing the effects from the ETC commenters’ concerns about the lead those barriers. Commenters also stated Learning Collaborative time to take time needed prior to participation in the that this approach would allow CMS to effect, together with the other proposed Model. We do not believe it is operate smaller model tests that would rules addressing the transplant system appropriate to stagger the produce more actionable results.

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Response: The ETC Model is designed ETC Model. We received comments on with ESRD, for purposes of the ETC to test whether the mechanisms our proposed definitions. Model. However, as we noted in the included in the Model will achieve the After considering public comments, proposed rule, analyses of claims data Model’s goals, through incentivizing we are finalizing our proposed revealed that a variety of clinician Managing Clinicians and ESRD facilities provisions on the definitions with specialty types manage ESRD to support modality choice. We view modification, as described elsewhere in Beneficiaries and bill the MCP, home dialysis and transplantation as this section IV of this final rule. including non-physician practitioners. complementary alternative renal Specifically, we are codifying in our We continue to believe that the replacement modalities, not as separate regulations at § 512.310 to define certain proposed approach to defining aims. Therefore, we do not see them as terms for the ETC Model. We have Managing Clinicians more accurately separable into two separate model tests. summarized the comments received and captures the set of practitioners we are We disagree that testing two separate responded to them through this section seeking to include as participants in the models would be needed to produce IV of the final rule, where relevant. ETC Model, rather than limiting the more actionable results, as the scope to self-identified nephrologists. 3. ETC Participants evaluation of the ETC Model is designed As proposed, the ETC Model would to detect an increase in either home a. Mandatory Participation require the participation of ESRD dialysis rates, transplant rates, or both. We proposed to require all Managing facilities and Managing Clinicians in After considering public comments, Clinicians and all ESRD facilities Selected Geographic Areas that might we are finalizing our proposed located in Selected Geographic Areas to not otherwise participate in a payment provisions regarding implementation of participate in the ETC Model. We model involving payment adjustments the ETC Model, with modification to proposed to define ‘‘selected geographic based on participants’ rates of home our regulation at § 512.320 to adjust the area(s)’’ as those Hospital Referral dialysis and kidney transplants. dates for application of the payment Regions (HRRs) selected by CMS, as Participation in other CMS models adjustments under the ETC Model. The described in the proposed rule and in focused on ESRD, such as the CEC start date for application of the ETC section IV.C.3.b of this final rule, for Model and the KCC Model, is optional. Model’s payment adjustments has purposes of selecting ESRD facilities Interested individuals and entities must changed from applying to claims with a and Managing Clinicians required to apply to such models during the claim through date beginning January 1, participate in the ETC Model as ETC applicable application period(s) to 2020, to claims with a claim service date Participants. Our proposed definition of participate. To date, we have not tested beginning on or after January 1, 2021. ‘‘Hospital Referral Regions (HRRs)’’ is an ESRD-focused payment model in The end date for application of such described in the proposed rule and in which ESRD facilities and Managing payment adjustments has changed from section IV.C.3.b of this final rule. Clinicians have been required to applying to claims with a claim through For purposes of the ETC Model, we participate. We considered using a date ending June 30, 2026, to claims proposed to define ‘‘ESRD facility’’ as voluntary design for the ETC Model as with a claim service date ending on or defined in 42 CFR 413.171. As we well; however, as noted in the proposed before June 30, 2027. We also are described in the proposed rule, under rule, we believe that a mandatory design modifying which date associated with § 413.171, an ESRD facility is an has advantages over a voluntary design the claim we are using to determine if independent facility or a hospital-based that are necessary to test this Model, in the claim is subject to the payment provider of services (as described in 42 particular. First, we believe that testing adjustments under the Model. Whereas CFR 413.174(b) and (c)), including a new payment model specific to we proposed using the claim through facilities that have a self-care dialysis encouraging home dialysis and kidney date, which is the last day on the billing unit that furnish only self-dialysis transplants may require the engagement statement for services furnished to the services as defined in § 494.10 and of an even broader set of ESRD care beneficiary, we are finalizing using the meets the supervision requirements providers than have participated in date of service on the claim, which is described in 42 CFR part 494, and that CMS models to date, including the date on which the service was furnishes institutional dialysis services providers and suppliers who would furnished. We are making this change and supplies under 42 CFR 410.50 and participate only in a mandatory ESRD from using claim through date to using 410.52. We proposed this definition payment model. As we discussed in the date of service to align with Medicare because this is the definition used by proposed rule, we are concerned that claims processing standards. While Medicare for the ESRD PPS. We only a non-representative and relatively Medicare claims data contains both considered creating a definition specific small sample of providers and claim through dates and dates of to the ETC Model; however, as noted in suppliers, namely those that already service, Medicare claims are processed the proposed rule, we believe that the have higher rates of home dialysis or based on dates of service. Therefore, in ESRD PPS definition of ESRD facility kidney transplants relative to the order to process payment adjustments, captures all facilities that furnish renal national benchmarks, would participate we will use the date of service to dialysis services that we are seeking to in a voluntary model, which would not determine the claims subject to include as participants in the ETC provide a robust test of the proposed adjustment under the Model. Model. payment incentives. In addition, For purposes of the ETC Model, we because kidney and kidney-pancreas 2. Definitions proposed to define ‘‘Managing transplants are rare events—fewer than We proposed at § 512.310 to define Clinician’’ as a Medicare-enrolled 4 percent of ESRD Beneficiaries certain terms for the ETC Model. We physician or non-physician practitioner received such a transplant in 2016—we describe these proposed definitions in who furnishes and bills the MCP for noted in the proposed rule that we context throughout the proposed rule managing one or more adult ESRD would need a large number of and section IV of this final rule. In Beneficiaries. In the proposed rule, we beneficiaries to be included in the addition, we proposed that the considered limiting the definition to model test and comparison groups in definitions proposed in section II of the nephrologists, or other specialists who order to detect a change in the rate of proposed rule also would apply to the furnish dialysis care to beneficiaries transplantation under the ETC Model.

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Second, as noted in the proposed rule, owned by dialysis organizations that the Medicare program authorize the ETC we believe that a mandatory design provide only home dialysis services Model as we have proposed and are combined with randomized selection of from participation in the Model. The finalizing it. a subset of geographic areas would ETC Model is designed to test the Section 1115A of the Act authorizes enable CMS to better assess the effect of effectiveness of the Model’s payment the Secretary to test payment and the Model’s interventions on ETC adjustments at improving or service delivery models expected to Participants against a contemporaneous maintaining quality and reducing costs reduce Medicare costs while preserving comparison group. As described in the through increased provision of home or enhancing care quality. The statute proposed rule and elsewhere in this dialysis and transplants throughout the does not require that models be section IV of the final rule, we proposed dialysis market as a whole, including voluntary, but rather gives the Secretary to require participation by a subset of all among ESRD facilities and dialysis broad discretion to design and test ESRD facilities and Managing Clinicians organizations that currently provide models that meet certain requirements in the U.S., selected based on whether only home dialysis. Excluding ESRD as to spending and quality. Although they are located in a Selected facilities and dialysis organizations that section 1115A(b) of the Act describes a Geographic Area. Also, we proposed to do not offer in-center dialysis could number of payment and service delivery evaluate the impact of adjusting discourage new entrants to the dialysis models that the Secretary may choose to payments to Managing Clinicians and market who use innovative care models test, the Secretary is not limited to those ESRD facilities by comparing the that do not include in-center dialysis. models. Rather, models to be tested clinical and financial outcomes of ESRD Discouraging this type of innovation under section 1115A of the Act must facilities and Managing Clinicians could limit the availability of home address a defined population for which located in these Selected Geographic dialysis overall. there are either deficits in care leading Areas against that of ESRD facilities and Comment: A commenter supported to poor clinical outcomes or potentially Managing Clinicians located in the proposal to include non-physician avoidable expenditures. Here, the ETC Comparison Geographic Area(s), which practitioners in the definition of Model addresses a defined population we proposed to define as those HRRs Managing Clinician for the purposes of (FFS Medicare beneficiaries with ESRD) that are not Selected Geographic Areas. the Model, as this recognizes the care for which there are potentially Because both ETC Participants and provided by other clinicians, including avoidable expenditures (arising from those ESRD facilities and Managing nurse practitioners, who manage less than optimal modality selection). Clinicians not selected for participation dialysis patients. For the reasons described elsewhere in in the Model would be representative of Response: We appreciate the this final rule, we have determined that the larger dialysis market, many of the commenters’ feedback and support. it is necessary to test this Model among stakeholders in which operate on a Comment: Several commenters stated varying types of ESRD facilities and nationwide basis, CMS would be able to that they support CMS’s proposal to Managing Clinicians that may not have generate more generalizable results, require participation in the ETC Model chosen to voluntarily participate in assuming randomization creates two by ESRD facilities and Managing another kidney care model, such as the groups that are similar to each other. As Clinicians located in Selected CEC Model or KCC Model. we noted in the proposed rule, this Geographic Areas. As noted elsewhere in this final rule, proposed model design would therefore Response: We appreciate the we are currently testing a number of make it easier for CMS to evaluate the commenters’ feedback and support. voluntary kidney models. We have impact of the Model, as required under Comment: Many commenters opposed designed the ETC Model to require section 1115A(b)(4) of the Act, and to requiring ESRD facilities and Managing participation by ESRD facilities and predict the impact of expanding the Clinicians to participate in the ETC Managing Clinicians in order to avoid Model under section 1115A(c) of the Model. Several commenters asserted the selection bias inherent to any model Act, if authorized, while also limiting that requiring participation by in which providers and suppliers may the scope of the model test to Selected approximately half of the country does choose whether to participate. As Geographic Areas. not constitute a model test, but rather a discussed in the proposed rule and The following is a summary of the substantive change to Medicare previously in this final rule, such a comments received on our proposed payment policy. Some commenters design will enable us to obtain a definitions for Managing Clinician and stated that this exceeds the scope of the representative sample, to detect a ESRD facility and our proposal to Innovation Center’s authority. Some change in the rate of transplantation require participation in the Model by commenters stated that, the scope and under the ETC Model, and to better Managing Clinicians and ESRD facilities mandatory nature of the Model, coupled assess the effect of the Model’s located in Selected Geographic Areas, with the downward payment interventions on ETC Participants and our responses. adjustments, constitute an overall against a contemporaneous comparison Comment: A commenter stated that, payment reduction for ESRD facilities group. Under the ETC Model, we will for the purposes of the ETC Model, CMS and Managing Clinicians, which will have tested and evaluated such a model should modify the proposed definition cause unintended consequences, across a wide range of ESRD facilities of ESRD facility to require that a facility including market consolidation, and Managing Clinicians. We believe it must either have or be in a network decrease in availability of services, and is important to gain knowledge from a under common ownership with ESRD disruption of patient care. variety of perspectives in considering facilities that have the capacity to Response: We do not believe that the whether and which models merit furnish in-center dialysis. size, scope, and duration of the Model expansion (including on a nationwide Response: We believe that adopting constitute a substantive change to basis). Thus, the ETC Model meets the this commenter’s recommendation Medicare payment policy, as the model criteria required for an initial model would be equivalent to excluding ESRD test is limited in duration and is not a test. facilities owned by dialysis permanent change to the Medicare Moreover, the Secretary has the organizations that provide home program. We also believe that both authority to establish regulations to dialysis only. We do not believe that it section 1115A of the Act and the carry out the administration of is necessary to exclude ESRD facilities Secretary’s existing authority to operate Medicare. Specifically, the Secretary has

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authority under both sections 1102 and design and test other models, and the skew the model test through selection 1871 of the Act to implement possibility of reduction of participation effects. We assume that only ESRD regulations as necessary to administer in other voluntary models. Several facilities and Managing Clinicians who Medicare, including testing this commenters asserted that the use of already have high rates of home dialysis payment and service delivery model. mandatory models undermines the and transplantation would opt in to We note that, while the ETC Model will creation of and participation in participation. This behavior would be a model, and not a permanent feature voluntary models. produce the appearance of artificially of the Medicare program, the Model will Response: CMS believes that it is high performance among ETC test different methods for delivering and important to test both the mandatory Participants, because any observed paying for services under the Medicare ETC Model and the voluntary KCC increase in performance could be due to program, which the Secretary has the Model at the same time, as both of these selection effects rather than change in clear authority to regulate. The models test different frameworks. The performance related to the Model’s proposed rule went into great detail solicitation for applicants for the KCC payment adjustments. This behavior about the proposed provisions of the Model for PY 1 was completed on would also remove high performers proposed ETC Model, enabling the January 22, 2020. CMS is satisfied with from the benchmarking group, which public to fully understand how the the number of applications that were would lower benchmarks for ETC proposed model was designed and submitted. We believe that we will have Participants, and therefore not provide could apply to affected providers and sufficient participation to be able to test as great an incentive for ETC suppliers. the different options in the KCC Model. Participants to improve their We also note that this is a new model, Though previous mandatory models performance under the Model. not an expansion of an existing model. tested by the Innovation Center may After considering public comments, As permitted by section 1115A of the have been smaller or cancelled in the we are finalizing the provisions Act, we are testing the ETC Model past, we believe that requiring regarding mandatory participation in within Selected Geographic Areas. The participation by ESRD facilities and the Model in our regulations at fact that the Model will require the Managing Clinicians in the ETC Model § 512.325(a) as proposed. We are also participation of certain ESRD facilities is necessary to achieve the level of finalizing the definition of Selected and Managing Clinicians does not mean model participation needed to detect Geographic Area(s) in our regulations at it is not an initial model test. If the ETC changes in the rates of dialysis modality § 512.310, as proposed, with a technical Model is successful such that it meets choice and for the power calculations change to capitalize ‘‘Selected the statutory requirements for discussed in this section of this final Geographic Area(s)’’ in the final rule, expansion, and the Secretary determines rule. As discussed in section IV.C.3.b of rather than use ‘‘selected geographic that expansion is warranted, we would this final rule, we are decreasing the area(s)’’ as we did in the proposed rule. undertake further rulemaking to expand size of the Model. This decrease from In addition, we are finalizing the the duration and the scope of the Model, 50% of HRRs in the country to 30% of definitions of ESRD facility in our as required by section 1115A(c) of the HRRs in the country brings the size of regulations at § 512.310, as proposed. Act. the Model more in line with other We are finalizing the definition of We appreciate the concerns from mandatory models. Managing Clinician in our regulation at commenters about the potential impact Comment: A commenter stated that § 512.310 with modification. of the Model on patient care, the they agree that the Innovation Center Specifically, we made a technical structure of the dialysis market, and the has the authority to proceed with change to capitalize ‘‘Managing availability of dialysis services. We do mandatory initiatives, and they support Clinician’’ in the final rule. not expect the Model will result in the testing of mandatory models Additionally, we have added new adverse results such as market established through the rulemaking language to our regulation to clarify that consolidation, decrease in availability of process. Managing Clinicians will be identified services, or disruption of patient care. In Response: We appreciate this by an National Provider Identifier (NPI), contrast, CMS believes that the Model feedback and support from the because an NPI uniquely identifies will have the opposite effects. The commenter. individual clinicians regardless of the payment adjustments in the Model are Comment: Several commenters stated location the Managing Clinician designed to incentivize innovative care that CMS should test this model on a furnishes a particular service, which is delivery methods that focus on voluntary basis. A commenter stated necessary for purposes of attributing expanding access to renal replacement that ESRD facilities and Managing services to each individual Managing therapies other than in center Clinicians located in Comparison Clinician, as described further in section hemodialysis, that are associated with Geographic Areas should be allowed to IV.C.5.b.(2).(b) of this final rule. better clinical outcomes for patients. opt in to the ETC Model. However, we intend to monitor the Response: We appreciate this b. Selected Geographic Areas impact of the Model closely, as feedback. However, as stated previously We proposed to use an ESRD facility’s described in section IV.C.10.a of this in this final rule, we considered using or Managing Clinician’s location in final rule. In the event that adverse a voluntary design for the Model, but we Selected Geographic Areas, randomly outcomes such as these arise, CMS concluded that we do not believe we selected by CMS, as the mechanism for would modify or terminate the Model can adequately test this Model on a selecting ETC Participants. We stated in accordingly. voluntary or opt in basis. Specifically, the proposed rule that we believe that Comment: Several commenters stated we do not believe that if the Model were geographic areas provide the best means that previous mandatory models have voluntary we would have a sufficient to establish the group of providers and been of smaller size, and a commenter number and diversity of ESRD facilities suppliers selected for participation in stated that CMS has cancelled proposed and Managing Clinicians to conduct a the Model and the group of providers mandatory models in the past, due to robust test. Additionally, allowing ESRD and suppliers not selected for further analysis, feedback that facilities and Managing Clinicians participation in the Model to answer the mandatory participation would have located in Comparison Geographic primary evaluation questions described negative impact on CMS’s flexibility to Areas to opt-in to the ETC Model could in the proposed rule and section IV.C.11

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of this final rule. Specifically, by using Actuary (OACT) forecasted an average too small and therefore too geographic areas as the unit for increase of 1.5 percentage points per operationally challenging to use for this randomized selection, we will be able to year. With a current home dialysis rate purpose, both due to the high number study the impact of the Model on of 8.6 percent,147 this represents an of counties and the relatively small size program costs and quality of care, both increase of 18 percent. To detect an of counties such that a substantial overall and between ESRD facilities and effect size of this magnitude with 80 number of Managing Clinicians practice Managing Clinicians selected for percent power and an alpha of 0.05, we in multiple counties. We also participation in the Model and those would need few HRRs included in the determined that states would be too ESRD facilities and Managing Clinicians intervention group. However, for heterogeneous in population size, and not selected for participation in the transplants, which are rare events, a that using states could confound the Model. substantial number of HRRs would be evaluation of the Model due to potential To improve the statistical power of needed to detect changes. OACT did not variation in state-level regulations the Model’s evaluation, we noted in the assume any change in its main relating to ESRD care. Additionally, the proposed rule our aim of including in projections but estimated that an use of counties or states could introduce the Model approximately 50 percent of additional 2,360 transplants would confounding spillover effects, such as adult ESRD Beneficiaries. To achieve occur over the course of the proposed where ESRD Beneficiaries receive care this goal, we proposed to assign all Model due to a lower discard rate for from a Managing Clinician in a county geographic areas, specifically HRRs, into deceased donor organs. With 20,161 or state selected for the Model and one of two categories: Selected transplants currently conducted on an dialyze in a county or state not selected Geographic Areas (those geographic annual basis,148 this represents an 11.7 for the Model, thus mitigating the effect areas for which ESRD facilities and percent increase over 5 years. To detect of the Model’s incentives on the Managing Clinicians located in the area an effect size of this magnitude with 80 beneficiary’s overall care. As we noted would be selected for participation in percent power and an alpha of 0.05, we in the proposed rule, HRRs are derived the ETC Model and would be subject to would need approximately 153 HRRs in from Medicare data based on hospital the Model’s Medicare payment the intervention group, which referral patterns, which are correlated adjustments for ESRD care); and represents 50 percent of the 306 HRRs with dialysis and transplant referral Comparison Geographic Areas (those in the US. As noted in the proposed patterns and which would therefore geographic areas for which ESRD rule, we believe random selection with mitigate potential spillover effects of facilities and Managing Clinicians a large sample of units, such as the 306 this nature. located in the area would not be HRRs, would safeguard against uneven We proposed to establish the Selected selected for participation in the ETC distributions of factors among Selected Geographic Areas by selecting a random Model and thus would be subject to Geographic Areas and Comparison sample of 50 percent of HRRs in all 50 customary Medicare payment for ESRD Geographic Areas, such as urban or states and the District of Columbia, care). Given the national scope of the rural markets, dominance of for-profit stratified by region. Regional major stakeholders in the dialysis dialysis organizations, and dense stratification would use the four Census- market and the magnitude of the population areas with greater access to defined geographic regions: Northeast, payment adjustments proposed for this transplant centers. South, Midwest, and West. Information Model, as stated in the proposed rule, In the proposed rule, we considered about Census-defined geographic we believe a broad geographic using Core Based Statistical Areas regions is available at https:// distribution of participants would be (CBSAs) or Metropolitan Statistical www2.census.gov/geo/pdfs/maps-data/ necessary to effectively test the impact Areas (MSAs) as the geographic unit of maps/reference/usus_regdiv.pdf.149 As of the proposed payment adjustments. selection. However, as we noted in the proposed, the stratification would We proposed to use HRRs as the proposed rule, neither CBSAs nor MSAs control for regional patterns in practice geographic unit of selection for selecting include rural areas and, due to the variation. If an HRR spans two or more ETC Participants. An HRR is a unit of nature of dialysis treatment, we believe Census-defined geographic regions, the analysis created by the Dartmouth Atlas inclusion of rural providers and HRR would be assigned to the region in Project to distinguish the referral suppliers is vital to testing the Model. which the HRR’s associated state is patterns to tertiary care for Medicare Specifically, as a significant proportion located. For example, the Rapid City beneficiaries, and is composed of groups of beneficiaries receiving dialysis live in HRR centered in Rapid City, South of zip codes. The Dartmouth Atlas rural areas and receive dialysis Dakota, contains zip codes located in Project data source is publicly available treatment from providers and suppliers South Dakota and Nebraska, which are at https://www.dartmouthatlas.org/. located in rural areas, we believe using in the Midwest Census Region, and zip Therefore, we proposed to define the a geographic unit of selection that does codes located in Montana and term ‘‘HRRs’’ to mean the regional not include rural areas would limit the Wyoming, which are in the West Census markets for tertiary medical care derived generalizability of the model findings to Region. For the purposes of the regional from Medicare claims data as defined by this population. stratification, we would consider the the Dartmouth Atlas Project at https:// In the proposed rule, we also Rapid City HRR and all zip codes www.dartmouthatlas.org. considered using counties or states as therein to be in the Midwest region, as With 306 HRRs in the U.S., we noted the geographic unit of selection. its affiliated state, South Dakota, is in in the proposed rule that we believe However, as noted in the proposed rule, the Midwest region. there will be a sufficient number of we determined that counties would be We proposed that the U.S. Territories, HRRs to support random selection and as that term is defined in section II of improve statistical power of the 147 United States Renal Data System, Annual Data the proposed rule and of this final rule, proposed Model’s evaluation. As noted Report, 2018. Volume 2. Chapter 1: Incidence, would be excluded from selection, as in the proposed rule, we conducted Prevalence, Patient Characteristics, and Treatment HRRs are not constructed to include power calculations for the outcomes of Modalities. https://www.usrds.org/2018/view/v2_ 01.aspx. these areas. home dialysis and kidney and kidney- 148 United States Renal Data System, Annual Data pancreas transplant utilization. For Report, 2018. Volume 2. Chapter 6: Transplantation. 149 This URL has been updated relative to the home dialysis, the CMS Office of the https://www.usrds.org/2018/view/v2_06.aspx. URL included in the proposed rule.

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In addition, outside of the proposed for the Model could lead to change in Medicare policy. Section randomization, we proposed that all unintended consequences and 1115A of the Act authorizes the HRRs for which at least 20 percent of disruption in care, and several Secretary to test payment and service the component zip codes are located in commenters stated that this would harm delivery models intended to reduce Maryland would be selected for smaller health care providers, in Medicare costs while preserving or participation in the ETC Model, in particular. A commenter stated that this improving care quality. The ETC Model conjunction with the Maryland Total national impact would undermine the would be a model tested under this Cost of Care (TCOC) Model currently integrity of the model test. authority, and not a permanent feature being tested in Maryland. These HRRs Response: We appreciate the feedback of the Medicare program. would not be included in the from commenters raising concerns Comment: Several commenters randomization process previously around the impact of the proposed expressed concern that requiring described. We stated in the proposed scope of the model test on health care participation by ESRD facilities and rule that CMS believes that the providers and beneficiaries. We Managing Clinicians located in 50 automatic inclusion of ESRD facilities acknowledge that the scope and percent of the 306 HRRs in the U.S. is and Managing Clinicians in these HRRs timeframe for implementing the Model beyond the level of participation as participants in the ETC Model would will require changes on the part of ETC necessary to evaluate the Model. Several be necessary because, while the Participants, which may take time to commenters suggested reducing the Maryland TCOC Model includes implement. As discussed previously in geographic scope of the Model to 20 incentives to lower the Medicare TCOC this final rule, we believe we have percent, 25 percent, or no larger than 25 in the state, including state addressed commenters’ concerns percent of HRRs in the country. Several accountability for meeting certain regarding the time needed to make these commenters suggested starting the Medicare TCOC targets, as well as global changes by delaying the Model start Model with a smaller geographic scope, budget payments that hold Maryland date to January 1, 2021. We further and increasing the scope in subsequent hospitals accountable for the Medicare believe we have addressed the years if the Model is successful. TCOC, there currently is no direct commenters’ concerns regarding the Response: We appreciate the mechanism to lower the cost of care for potential for unintended consequences commenters’ feedback. In response to ESRD Beneficiaries specifically under through the benchmarking and scoring comments, and because we will now the Maryland TCOC Model. As noted in methodology (described in section evaluate changes to transplant the proposed rule, we believe that IV.C.5.d of this final rule) and have waitlisting, including beneficiaries who adding Maryland-based ESRD facilities addressed the commenters’ concerns receive living donor transplantation we and Managing Clinicians as participants regarding smaller health care providers conducted a revised power calculation. in the ETC Model will assist the state of through the low volume exclusions from We performed the revised power Maryland and hospitals located in that the PPA (described in section IV.C.5.f of calculation to determine the minimum state to meet the Medicare TCOC targets this final rule). We do not believe that sample size of ETC Participants and established under the Maryland TCOC the scope of the ETC Model harms the Managing Clinicians and ESRD facilities Model. integrity of the model test. Rather, as located in Comparison Geographic We proposed that all HRRs that are discussed in the proposed rule and Areas necessary to produce robust and not Selected Geographic Areas would be previously in this final rule, we reliable results. Our assumptions referred to as ‘‘Comparison Geographic designed the Model based on power included a two percentage point Area(s).’’ We proposed that Comparison calculations about the scope of increase to the transplant waitlist rate, Geographic Areas would be used for the participation necessary for CMS to be which is currently 16%. To detect an purposes of constructing performance able to evaluate whether the Model effect size of this magnitude with 80 benchmarks (as discussed in the increased the rate of transplants. percent power and an alpha of 0.05, we proposed rule and in section IV.C.5.d of However, as described in section IV.C.5 would need approximately 30 percent of this final rule), and for the Model of this final rule, we have modified the the 306 HRRs in the US to minimize the evaluation (as discussed in the proposed Model to assess ETC Participant risk of false positive and false negative rule and in section IV.C.11 of this final performance on the transplant rate, results. This number of HRRs will also rule). which includes both the transplant be sufficient to detect a one and one-half The following is a summary of the waitlist rate and living donor transplant percent change in home dialysis. As a comments received on Selected rate. As such, we have revised the scope result, we are finalizing our proposal to Geographic Areas, including the size of the Model based on power require participation in the Model by and scope of the Model, geographic calculations about the level of ESRD facilities and Managing Clinicians units used for Selected Geographic participation necessary for CMS to be located in 30 percent of the HRRs in the Areas, and the inclusion or exclusion of able to evaluate whether the Model country. certain geographic areas in the Model, increased the rate of transplant Comment: A few commenters noted and our responses. waitlisting, living donor transplants, that the proposed geographic scope of Comment: Multiple commenters and the rate of home dialysis, as the Model may lead to a spillover effect opposed our proposal to require described in section IV.C.5 of this final for ESRD facilities located in the participation in the ETC Model by ESRD rule. We discuss our plan for Comparison Geographic Areas given facilities and Managing Clinicians conducting the Model’s evaluation in that ownership of ESRD facilities can located in 50 percent of the 306 HRRs section IV.C.11 of this final rule. span across HRRs in Selected in the country because doing so would Comment: Several commenters stated Geographic Areas and Comparison require significant change to the that implementing the Model with this Geographic Areas. infrastructure of ETC Participants and to proposed geographic scope would Response: We share the commenters’ the care delivery system nationally. constitute a permanent change in concern that the impact of the model Commenters stated that the change in Medicare policy, rather than a model test may extend to the Model’s payments under the Model test. Comparison Geographic Areas through implemented over the proposed Response: We disagree that this common facility ownership and this geographic area within the timeframe Model would constitute a permanent may influence our evaluation of the

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Model. We plan to examine the Model is based around the number of acknowledge the possibility that variation in the outcome measures prior HRRs in which ESRD facilities and national dialysis providers will behave to and during the model intervention for Managing Clinicians would be required differently, in terms of resource facilities with common ownership, and to participate in the Model, not the allocation or adoption of best practices if necessary, consider modifications to proportion of individual beneficiaries in Selected Geographic Areas versus the Model in future notice-and- included in the model test. The same Comparison Geographic Areas, or that comment rulemaking. holds true for this final rule; our they will adopt best practices nationally Comment: A commenter supported determination regarding the size of the resulting in broader changes to dialysis randomizing geographic areas to select geographic area necessary to test the provision. However, we believe that, for ETC Participants. Several commenters Model is based around the number of dialysis providers that operate opposed randomization of geographic HRRs in which ESRD facilities and nationally, either outcome would be areas as the mechanism for selecting Managing Clinicians are required to true regardless of what mechanism we ETC Participants. Several commenters participate in the Model, rather than the use to select ESRD facilities for model noted that the method proposed for proportion of individual beneficiaries participation. As described in section randomization would not sufficiently included in the model test. We are IV.C.10.a of this final rule, we will account for non-random differences therefore finalizing the randomization monitor for unintended consequences between HRRs or ESRD facilities. A few method, as proposed. that arise as a result of the Model. commenters suggested that CMS use Comment: A commenter stated that Comment: Several commenters covariate-based constrained CMS should select regions where home recommended that CMS should select randomization for purposes of selecting dialysis and transplant rates are individual participants, rather than model participants because the particularly low to focus resources on selecting participants based on commenters claimed that this approach areas with the most need. geographic location. would ensure comparability across Response: As stated in the proposed Response: We did not propose treatment and control groups and allow rule and previously in this final rule, selecting individual participants for a smaller model. the intent of the model test is to because we believe that this approach Response: We appreciate the determine whether adjusting the current would not work for this Model. A comments on the proposed Medicare FFS payments for dialysis and design feature of the Model is aligning randomization method. As we noted in dialysis-related services would the incentives for key dialysis providers, the proposed rule and previously in this incentivize ESRD facilities and namely Managing Clinicians and ESRD final rule, our proposal to stratify by Managing Clinicians to work with their facilities, to support beneficiaries in region would help control for regional patients to achieve increased rates of choosing alternative renal replacement patterns in practice variation. We also home dialysis utilization and kidney modalities. Managing Clinicians refer believe that stratification will help transplantation and, as a result, reduce ESRD Beneficiaries to multiple ESRD ensure that ETC Participants are Medicare expenditures while improving facilities, and ESRD facilities furnish geographically dispersed across the or maintaining quality of care. If we dialysis to beneficiaries under the care country and do not find it necessary to were to select ETC Participants from of multiple Managing Clinicians. By use covariate-based constrained only those geographic areas that had selecting ETC Participants based on randomization for purposes of selecting particularly high or particularly low location, we are increasing the model participants, as suggested by rates of home dialysis or transplants, as likelihood that, for any given ESRD some of the commenters. In addition, the commenter suggested, we would not Beneficiary, both the beneficiary’s with the evaluation approach that will be able to determine if the Model’s Managing Clinician and ESRD facility be used, we can account for known, payment adjustments would have the are participants in the Model. measurable differences between ETC same effect nationally. Comment: Several commenters Participants in Selected Geographic Comment: Several commenters recommended that CMS release the Areas and those ESRD facilities and opposed the use of geographic areas to Selected Geographic Areas with the Managing Clinicians located in the select model participants. These proposed rule to allow for public Comparison Geographic Areas through commenters stated that, due to the comment or for potential model rigorous statistical methods. national nature of the dialysis market, participants to have sufficient time to Specifically, as we outlined in the selecting ESRD facilities for prepare for participation. A commenter proposed rule, the evaluator would participation based on their location stated that while they understand that match Managing Clinicians and ESRD could change the nature of the dialysis CMS has withheld information about facilities located in Comparison market for the entire country or create Selected Geographic Areas to assure that Geographic Areas with Managing unintended consequences for the CMS receives stakeholder feedback from Clinicians and ESRD facilities that are dialysis market nationally. In particular, the entire nation, ETC Participants located in Selected Geographic Areas commenters stated that the Model could should have no fewer than 90 days’ (that is, ETC Participants) using make national dialysis companies notice prior to implementation to propensity scores or other accepted provide different levels of care to prepare for participation in the Model. statistical techniques. patients in Selected Geographic Areas Response: We appreciate the Comment: Several commenters stated than in Comparison Geographic Areas commenters’ suggestions about releasing that randomization cannot ensure that and delay the implementation of best information about Selected Geographic 50 percent of ESRD Beneficiaries are practices nationally, or divert resources Areas in advance of the start of the included in the Model. from Comparison Geographic Areas to Model, and the need for ETC Response: While the aim stated in the Selected Geographic Areas. Participants to have sufficient time to proposed rule was to include Response: We appreciate the feedback prepare for participation in the Model. approximately 50 percent of adult from commenters about the national We did not provide information about beneficiaries with ESRD in the Model, nature of segments of the dialysis the specific Selected Geographic Areas as described in the proposed rule, our market and how this may interact with in the proposed rule because, as the determination regarding the size of the our proposal to select ETC Participants commenters noted, we wanted to ensure geographic area necessary to test the based on geographic areas. We that we received feedback from the

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public generally, not just those in Comparison Geographic Areas to a result of this misalignment, using stakeholders located in Selected attempt to keep benchmarks low, to HRRs may have unintended Geographic Areas. CMS is posting a list improve relative performance for their consequences. A commenter stated that of Selected Geographic Areas on the ESRD facilities located in Selected the misalignment between dialysis Innovation Center website concurrent Geographic Areas. company markets and HRRs could with the release of this final rule, thus Response: We appreciate the feedback create a situation where ESRD facilities notifying the public and ETC from commenters about the potential for owned by a dialysis organization with a Participants of the Selected Geographic dialysis organizations operating in both centralized home dialysis facility are Areas more than 90 days in advance of Selected Geographic Areas and selected to participate in the Model but the start of the Model on January 1, Comparison Geographic Areas to the affiliated home dialysis facility is 2021. manipulate the Model’s benchmarks. not selected to participate, which would Comment: Commenters expressed However, we believe that the not accurately reflect the provision of concerns about how the method for achievement benchmarking home dialysis by that company in that randomly selecting participating HRRs methodology, described in the proposed area. Other commenters stated that will interact with the benchmarking rule and in section IV.C.5.d of this final beneficiaries or ETC Participants may methodology using data from rule, mitigates this risk. First, the move between HRRs, or may seek or Comparison Geographic Areas. proposed achievement benchmarks provide care in multiple HRRs. Commenters stated that random would use only data from home dialysis Response: We appreciate commenters’ selection does not address other and transplant rates among ESRD concerns about the relationship between covariates that impact home dialysis facilities and Managing Clinicians the geographic distribution of providers and transplant rates, including current located in Comparison Geographic and suppliers involved in the provision rates of home dialysis and Areas. Because we will construct these of services to ESRD Beneficiaries and transplantation, urbanicity, population benchmarks using 12 months of data the geographic unit of selection used in density, percentage of dual-eligible beginning 18 months before the start of the ETC Model. Providing care to ESRD beneficiaries, and the availability of the MY and ending 6 months before the Beneficiaries involves multiple parts of transplant centers. Commenters stated start of the MY, the time periods for the health care system—including ESRD that, if balance on these covariates is not determining achievement benchmarks facilities and dialysis organizations, as observed, model participants could be for MY1 and MY2 occurred primarily well as Managing Clinicians and the unfairly compared to ESRD facilities before the proposal or finalization of the and Managing Clinicians located in rule to implement the Model. For MY3, practices in which they operate—each Comparison Geographic Areas that face the proposed achievement benchmarks of which furnishes care in a unique different factors that contribute to home would include 6 months of data from geographic area or set of geographic dialysis and transplant rates. before the Model and 6 months of data areas. Because there are so many Response: We appreciate the after the Model began. Only in MY4 overlapping geographies served by these commenters’ concern that underlying would all data used to construct the providers and suppliers, it is unlikely regional variation in home dialysis and achievement benchmarks be from after that there is one type of geographic unit transplant rates may mean that ETC the Model began. It would therefore be that would align perfectly, such that no Participants and ESRD facilities and difficult for dialysis organizations to dialysis organization market is in both Managing Clinicians located in alter their past performance in order to Selected Geographic Areas and Comparison Geographic Areas will face manipulate these achievement Comparison Geographic Areas, or that varying factors that affect their rates of benchmarks for the initial years of the no Managing Clinician sees patients in home dialysis and transplants. Model. Additionally, we stated in the both Selected Geographic Areas and However, as we noted in the proposed proposed rule that it is our intent to Comparison Geographic Areas. We rule and earlier in this final rule, our increase achievement benchmarks above continue to believe that HRRs are the proposal to stratify by region would the rates observed in Comparison most appropriate geographic unit of help control for regional patterns in Geographic Areas for future MYs selection for the Model, for the reasons practice variation. We also believe that through subsequent rulemaking. For described in the proposed rule and inclusion of improvement scoring in the these subsequent MYs, we are elsewhere in this section of the final scoring methodology, described in the considering an approach under which rule. Also, we believe that the proposed rule and in section IV.C.5.d. of achievement benchmarks would not be aggregation methodology used in this final rule, which awards points tied to performance in Comparison assessing ETC Participant performance based on an ETC Participant’s Geographic Areas, so there would not be (described in section IV.C.5.c.(4) of this improvement against its own past an opportunity for LDOs to manipulate final rule) addresses concerns about performance, will help compensate for the achievement benchmarks by individual ETC Participant performance any underlying regional variation in changing their performance in assessment in relation to geography. We these factors. Comparison Geographic Areas if this acknowledge that ETC Participants may Comment: Several commenters stated approach is finalized. move between HRRs or provide care in that, due to the national nature of the Comment: Several commenters stated multiple HRRs, and we do not believe dialysis market, large dialysis that HRRs may not be reflective of how that this harms the model test. It is companies will have ESRD facilities dialysis care is delivered, how organ commonplace for participants to move located in both Selected Geographic transplants are allocated, or referral into and out of Innovation Center Areas and in the Comparison patterns between Managing Clinicians models on occasion, and this movement Geographic Areas used for and ESRD facilities. Commenters generally does not harm model benchmarking under the ETC Model. pointed out that HRRs are designed to evaluations. As to the movement of These commenters stated that dialysis capture patterns of care in hospitals for ESRD Beneficiaries, because the level at companies could face incentives to Medicare beneficiaries, but may not be which performance is being assessed is either not improve on or not maintain reflective of other segments of the health the ETC Participant, not the beneficiary, current home dialysis and transplant care market, including dialysis services. and attribution of ESRD Beneficiaries to performance in ESRD facilities located These commenters further stated that, as ETC Participants occurs in units of one

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month, we do not believe that rule and elsewhere in this section of the participate in the ETC Model pursuant beneficiaries moving between HRRs will final rule. to § 512.325(a), which describes the impact the model test. Comment: A commenter supported selection of model participants based on Comment: Several commenters our proposal to select for participation their location within a Selected suggested using different geographic all HRRs for which at least 20 percent Geographic Area, as described in the units to select ETC Participants, of the component zip codes are located proposed rule and previously in this including CBSAs. A commenter in Maryland, outside of the final rule. In addition, we noted in the supported using CBSAs instead of HRRs randomization, in conjunction with the proposed rule that the definition of because CBSAs are well understood by Maryland TCOC Model currently being ‘‘model participant,’’ as defined in health care providers. Other tested in Maryland. A commenter section II of this final rule, would commenters opposed using CBSAs opposed including these Maryland include an ETC Participant. instead of HRRs for several reasons, HRRs, or any other states participating The following is a summary of the including that CBSAs are smaller than in Innovation Center models, outside of comments received on providers and HRRs and would therefore exacerbate the randomization, as states are large suppliers included as ETC Participants divisions of participants and geographic units and the commenter and our responses. beneficiaries because the likelihood of a opposes the size of the Model. Comment: Several commenters stated beneficiary being attributed to a Response: We appreciate the feedback that the ETC Model should include participating ESRD facility and non- from commenters about the inclusion of transplant providers as participants, participating Managing Clinician (and HRRs predominantly located in including transplant centers, transplant vice versa) would increase, and that Maryland. We do not believe that physicians, transplant surgeons, OPOs, donor hospitals, and other transplant CBSAs do not include rural counties including these HRRs outside of the randomization harms the providers in order to achieve the and CMS did not propose a method for randomization, or represents a Model’s focus on increasing rates of associating rural counties with CBSAs. significant increase in the size of the kidney transplantation. Commenters Others suggested alternative geographic Model. We are therefore finalizing this asserted that transplant providers hold units for selecting ETC Participants. A policy as proposed. more control over the transplant process commenter suggested that CMS use Comment: Several commenters stated than Managing Clinicians and ESRD regions that align with market areas for that they support the proposed facilities, so including them in the other payers, such as Medicare exclusion of the U.S. Territories from Model’s payment adjustments would be Advantage plans and other private the Selected Geographic Areas under necessary for or would increase the payers, to prevent ETC Participants from the ETC Model. likelihood of Model success. having to ask other clinicians (such as Response: We appreciate the feedback Response: We appreciate the primary care providers.) to provide and support from the commenters. suggestions from commenters about different levels of care to ESRD patients After considering public comments, including transplant providers in the based on participation in the Model. we are finalizing our proposed Model. We agree that transplant That commenter also suggested that provisions on Selected Geographic providers are central to increasing CMS use a variety of geographic units to Areas in our regulations at § 512.325(b), transplant rates. However, we do not select participants similar to the method with modification. We are modifying believe that it is necessary to include used in the design of the Civil Justice the proportion of HRRs randomly transplant providers as participants Reform Act experiments in the 1990s, in selected for inclusion in the Model as receiving payment adjustments in this particular that CMS select participants Selected Geographic Areas from 50 Model. First, the ETC Model is designed in those states that have expressed percent to 30 percent. We are finalizing to test the effectiveness of a particular interest in and wish to implement the definition of Selected Geographic set of policy interventions, namely regulatory changes in conjunction with Area(s) as proposed with the technical adjusting certain Medicare payments for the Model, as states play a regulatory change to capitalize the term ‘‘Selected Managing Clinicians and ESRD facilities role in the provision of dialysis care. A Geographic Area(s)’’ in the final rule. to increase rates of home dialysis and commenter suggested using the ESRD We are also finalizing as proposed the kidney transplants. As noted previously Networks as the geographic units to definition of hospital referral regions in this final rule, we selected Managing select ETC Participants, as the ESRD (HRRs), and we are clarifying that we Clinicians and ESRD facilities as Networks have longstanding will use the 2017 HRRs for the duration participants in this Model because we relationships with dialysis and of the ETC Model. HRRs are believe these two groups of health care transplant programs, personnel, and recalculated periodically to reflect providers have the most direct patients, and could support participants changes in patterns of care over time. At relationship with ESRD Beneficiaries. to achieve the goals of the Model. A the time of publication of the proposed Second, CMS and HHS are undertaking commenter suggested incorporating rule, the 2017 HRRs are the most current other activities targeting the availability Donation Service Areas (DSAs) into the available. We are also finalizing as of organs for transplantation. These geographic unit selection process. proposed the definition of Comparison efforts include the ETC Learning Response: We appreciate the feedback Geographic Area(s), with the technical Collaborative described in section from commenters about the use of change to capitalize the term IV.C.12 of this final rule, which alternative geographic units to select ‘‘Comparison Geographic Area(s)’’ in the includes transplant centers and OPOs. ETC Participants. We acknowledge that final rule. We are codifying these As previously noted, HHS published a there are a variety of types of geographic definitions in our regulations at proposed rule in the Federal Register on units we could use to select ETC § 512.310. the December 23, 2019, entitled Participants, and that there are benefits ‘‘Medicare and Medicaid Programs; and challenges associated with each c. Participant Selection for the ETC Organ Procurement Organizations option. We continue to believe that Model Conditions for Coverage: Revisions to HRRs are the most appropriate unit of We proposed to define ‘‘ETC the Outcome Measure Requirements for geographic selection for this Model, for Participant’’ as an ESRD facility or Organ Procurement Organization[s]’’ (84 the reasons described in the proposed Managing Clinician that is required to FR 70628). This proposed rule would,

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among other things, update the OPO that ESRD facilities owned in whole or currently certified to provide home Conditions for Coverage to support in part by a dialysis organization dialysis should be selected for higher donation rates and reduce owning 35 or fewer ESRD facilities participation, to preserve the quality of discard rates of viable organs. The should be excluded from the Model, care associated with centralization of Health Resources and Services while another commenter recommended home dialysis, to avoid unintended Administration (HRSA) also published a that ESRD facilities owned by these adverse outcomes, and/or to avoid proposed rule in the Federal Register on smaller dialysis organizations be penalizing ESRD facilities that cannot December 20, 2019, entitled ‘‘Removing allowed to opt in to the Model on a become certified to provide home Financial Disincentives to Living Organ voluntary basis. A commenter dialysis in a timely manner. Several Donation’’ (84 FR 70139) to remove recommended that CMS exclude commenters stated that the Model financial barriers to organ donation by dialysis organizations with fewer than should exclude from participation those expanding the scope of reimbursable 100 patients in a market area. A ESRD facilities that are owned by expenses incurred by living organ commenter suggested that no more than dialysis organizations that own only donors to include lost wages and 25 percent of a dialysis organization’s ESRD facilities that provide home childcare and elder-care expenses ESRD facilities should be included in dialysis or that provide home dialysis incurred by a primary care giver. We the Model, while another commenter only in a Selected Geographic Area to believe that the increased volume of suggested that any health care provider avoid ‘‘cherry picking’’ by home beneficiaries on the transplant waitlist that would have more than 10 percent dialysis-only organizations, resulting in driven by the payment adjustments in of all of their treatments subject to the unfair comparisons in the PPA the ETC Model, together with the Model’s payment adjustments should be benchmarking methodology. increased organ availability from other excluded from the Model. A commenter Response: We do not believe that it is HHS and CMS efforts and the ETC recommended that ESRD facilities that necessary to exclude ESRD facilities that Learning Collaborative, will serve as an decide that it is not logical or possible do not currently provide home dialysis incentive for transplant providers to for them to offer home dialysis should services from the Model, nor do we support increasing rates of be allowed to opt out of participation in believe that it is necessary to exclude transplantation. As discussed in section the Model. ESRD facilities owned by dialysis IV.C.5.c.(2) of this final rule, it is our Response: The Model was designed to organizations that provide only home intent to observe organ availability. test the proposed payment adjustments dialysis. The ETC Model is designed to After considering public comments, for all types of ESRD facilities test the effectiveness of the Model’s we are finalizing our proposed nationally, including those owned by payment adjustments at improving or definition of ETC Participant without both large and small dialysis maintaining quality and reducing costs modification, and codifying this organizations. To determine if payment through increased provision of home definition in our regulations at adjustments can achieve the Model’s dialysis and transplants on the dialysis § 512.310. goals of increasing rates of home market as a whole, including ESRD dialysis utilization and kidney facilities new to the provision of home (1) ESRD Facilities transplantation and, as a result, dialysis, as well as new entrants to the We proposed that all Medicare- improving or maintaining the quality of dialysis market who offer innovative certified ESRD facilities located in a care while reducing Medicare approaches to dialysis provision that do Selected Geographic Area would be expenditures among all types of ESRD not include in-center dialysis. required to participate in the ETC facilities, we need to test the model with Excluding these ESRD facilities from the Model. We proposed to determine ESRD ESRD facilities owned by all types of model test could limit the Model’s facility location based on the zip code dialysis organizations. Additionally, ability to increase provision of home of the practice location address listed in while we include all ESRD facilities in dialysis services by these dialysis the Medicare Provider Enrollment, the HDPA, as described in the proposed providers by discouraging new entrants Chain, and Ownership System (PECOS). rule and in section IV.C.5.e.(1) of this to the market who may employ We considered using the zip code of the final rule, the Model excludes certain innovative approaches to home dialysis. mailing address listed in PECOS. ESRD facilities that fall below the low After considering public comments, However, we concluded that mailing volume threshold from the application we are finalizing our proposal in our address is a less reliable indicator of of the PPA. We believe that this regulation at § 512.325(a) to require all where a facility is physically located approach balances the need to include Medicare-certified ESRD facilities than the practice location address, as all types of ESRD facilities in the model located in a Selected Geographic Area to facilities may receive mail at a different test with the need to increase statistical participate in the Model, without location than where they are physically reliability and to exclude low-volume modification. located. ESRD facilities from the PPA, which is (2) Managing Clinicians The following is a summary of the the only downside financial risk comments received on required included in the Model. We do not We proposed that all Medicare- participation for all ESRD facilities believe that it is appropriate to allow enrolled Managing Clinicians located in located in Selected Geographic Areas ESRD facilities to opt in or out of the a Selected Geographic Area would be and our responses. Model for the purposes of the model required to participate in the ETC Comment: Several commenters test, as this would exacerbate potential Model. We proposed identifying the suggested that CMS exclude certain selection effects. Managing Clinician’s location based on ESRD facilities from selection for Comment: Several commenters the zip code of the practice location participation in the ETC Model. In recommended that CMS adopt address listed in PECOS. If a Managing particular, these commenters stated that requirements around what types of Clinician has multiple practice location ESRD facilities owned by small dialysis dialysis an ESRD facility, or its parent addresses listed in PECOS, we proposed organizations would face substantial dialysis organization, must provide in to use the practice location through hardship and financial risk if selected order to be selected for participation in which the Managing Clinician bills the for participation. Several of these the Model. Some commenters stated plurality of his or her MCP claims. In commenters specifically recommended that only ESRD facilities that are the proposed rule, we considered using

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the zip code of the mailing address selection method would be more description of the learning collaborative, listed in PECOS. However, as noted in complex, and would make it more see section IV.C.12 of this final rule. the proposed rule, we determined that difficult for Managing Clinicians to The following is a summary of the mailing address is a less reliable understand whether they are ETC comments received on the HDPA and indicator of where a clinician physically Participants in real time, as beneficiary our responses. practices than the practice location attribution occurs after each MY has Comment: A commenter expressed address, as clinicians may receive mail ended. support for the proposed HDPA because at a different location from where they After considering public comments, it would enable the increased use of physically practice. we are finalizing our proposal in our home dialysis for appropriate ESRD The following is a summary of the regulation at § 512.325(a) to require all Beneficiaries. Another commenter comments received on required Medicare-enrolled Managing Clinicians expressed concern that, while CMS participation for all Managing Clinicians located in a Selected Geographic Area to recognized that the initial transition located in Selected Geographic Areas participate in the ETC Model, without period onto dialysis is important for and our responses. modification. supporting ESRD Beneficiaries in Comment: A commenter asked for selecting home dialysis, the proposed clarification as to whether individual 4. Home Dialysis Payment Adjustment HDPA is tied to claims submitted for Managing Clinicians would be selected We proposed to positively adjust home dialysis, and would thus provide for participation based on their location payments for home dialysis and home the largest benefit to ESRD facilities and or if practices with Managing Clinicians dialysis-related services billed by ETC Managing Clinicians that already have would be selected for participation Participants for claims with claim the infrastructure in place to support based on their location. through dates during the first three CYs increased use of home dialysis. A Response: Managing Clinicians will of the ETC Model (CY 2021–CY 2023). commenter expressed opposition to be selected individually based on their We stated that the HDPA would provide providing the HDPA to ESRD facilities, location and not the practice location. an up-front positive incentive for ETC given that, in the commenter’s view, However, as described in the proposed Participants to support ESRD ESRD facilities already have an rule and in section IV.C.5.c.(4) of this Beneficiaries in choosing home dialysis. incentive to furnish home dialysis final rule, the performance of Managing The HDPA would complement the PPA, services over in-center dialysis services. Clinicians that bill through the same described in the proposed rule and According to the commenter, the profit practice TIN will be aggregated to the section IV.C.5 of this final rule, which margin for home dialysis is generally practice level for purposes of under our proposal would begin in mid- higher than or equal to in-center dialysis determining the PPA. CY 2021 and increase in magnitude over for ESRD facilities, but the returns on Comment: A commenter the duration of the Model; as such we capital are substantially higher when recommended that CMS not determine proposed that the HDPA would decrease providing home dialysis services, as a Managing Clinician’s location based over time as the magnitude of the PPA fewer fixed assets are required to on where he or she provides the increases. There would be two types of furnish home dialysis services than in- plurality of his or her MCP claims. The HDPAs: The Clinician HDPA and the center dialysis. commenter stated that this could create Facility HDPA. We proposed to define Response: We thank the commenters misalignment between incentives for the ‘‘Clinician HDPA’’ as the payment for their feedback. CMS recognizes that Managing Clinicians and ESRD facilities adjustment to the MCP for a Managing by tying the HDPA to home dialysis and if a Managing Clinician has patients Clinician who is an ETC Participant for home dialysis-related claims, ETC who dialyze at ESRD facilities that are the Managing Clinician’s home dialysis Participants who furnish higher ETC Participants as well as at ESRD claims, as described in § 512.345 numbers of home dialysis and home facilities located in Comparison (Payments Subject to the Clinician dialysis-related services at the outset of Geographic Areas, and therefore CMS HDPA) and § 512.350 (Schedule of the Model will receive more HDPA should select Managing Clinicians based Home Dialysis Payment Adjustments). payments under the Model. However, on the location where dialysis services We proposed to define the ‘‘Facility this does not detract from the incentives are provided to their patients. HDPA’’ as the payment adjustment to to increase rates of home dialysis Response: We recognize that the Adjusted ESRD PPS per Treatment created by the HDPA, particularly in Managing Clinicians provide dialysis Base Rate (discussed in section IV.B of combination with the PPA, and CMS management services included in the this final rule) for an ESRD facility that believes the proposed HDPA is an MCP to ESRD Beneficiaries that dialyze is an ETC Participant for the ESRD appropriate means to incentivize the at multiple ESRD facilities, and that in facility’s home dialysis claims, as increased provision of home dialysis some cases, this may mean that a described in § 512.340 (Payments and home dialysis-related services Managing Clinician may have ESRD Subject to the Facility HDPA) and while also rewarding those who are Beneficiaries who dialyze at ESRD § 512.350 (Schedule of Home Dialysis already furnishing high rates of home facilities that are ETC Participants and Payment Adjustments). We proposed to dialysis and home dialysis-related ESRD Beneficiaries that dialyze at ESRD define the ‘‘HDPA’’ as either the Facility services. CMS disagrees with the facilities located in Comparison HDPA or the Clinician HDPA. As we commenter’s suggestion to eliminate the Geographic Areas. However, selecting noted in the proposed rule, we do not Facility HDPA. The commenter’s Managing Clinicians based on where believe that an analogous payment statement that ESRD facilities currently their attributed beneficiaries dialyze adjustment is necessary for increasing have a greater incentive to provide would not solve this issue, as a kidney transplant rates during the initial home dialysis over in-center dialysis is Managing Clinician could still provide years of the ETC Model. Rather, instead directly contradicted by the data on dialysis management services to ESRD of creating a payment adjustment, we relative rates of in-center and home Beneficiaries who dialyze at ESRD proposed to implement the ETC dialysis described in the proposed rule facilities that are ETC Participants and Learning Collaborative that focuses on and previously in this final rule. The at ESRD facilities that are located in disseminating best practices to increase overwhelming majority of ESRD Comparison Geographic Areas. Also, we the supply of deceased donor kidneys Beneficiaries, including ESRD believe that the commenter’s suggested available for transplant. For a Beneficiaries for whom Medicare is a

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secondary payer, currently receive in- Dialysis Payment Adjustment (Facility Response: We thank the commenters center dialysis rather than home HDPA) in our regulation at § 512.300 for their feedback. We agree that CMS’s dialysis. without modification, other than the proposal to apply the HDPA to all ETC Comment: A commenter technical change to capitalize every Participants aligns with the Model’s recommended that CMS apply the word of each of these terms (for goals by incentivizing an increase in HDPA to payments for devices and example, in the proposed rule, we home dialysis rates, which we expect to procedures related to creation of proposed to define ‘‘Home dialysis improve or maintain quality while vascular access for dialysis, and reduce payment adjustment,’’ but in this final reducing costs. Regarding the payments for interventions, such as rule we are defining the term ‘‘Home commenter’s recommendation that CMS angioplasty and stenting, which are Dialysis Payment Adjustment’’). apply the HDPA to all ESRD providers, performed when a vascular means of a. Payments Subject to the HDPA we are finalizing our proposal to apply access becomes clogged. the HDPA only to ETC Participants to Response: It is not clear whether the We proposed that the HDPA would allow us to compare the rates of home commenter was suggesting that CMS apply to all ETC Participants for those dialysis between ETC Participants (who adjust payments for vascular access payments described in the proposed are subject to the HDPA) and ESRD device and procedures to supplement or rule and in sections IV.C.4.b and facilities and Managing Clinicians supplant our proposed payment IV.C.4.c of this final rule, according to located in Comparison Geographic adjustments to claims for home dialysis the schedule described in the proposed Areas (who are not subject to the HDPA) and home dialysis-related services. rule and section IV.C.4.d of this final for purposes of evaluating whether the Either way, if ETC Participants use rule. We solicited comment on our HDPA statistically impacts the devices and procedures related to proposal to apply the HDPA with provision of home dialysis. creating vascular access for dialysis, and respect to all ETC Participants, without Comment: A commenter expressed the ESRD Beneficiaries who acquire exceptions. strong support for CMS’s proposal to vascular access then receive home We also proposed that the HDPA apply the HDPA to claims where would apply to claims where Medicare dialysis or home dialysis-related Medicare is the secondary payer. services, Medicare payments for those is the secondary payer for coverage Response: We thank the commenter under section 1862(b)(1)(C) of the Act. home dialysis and home dialysis-related for the feedback and support. services will be adjusted by the HDPA. We explained that when a beneficiary After considering public comments, eligible for coverage under an employee Moreover, vascular access, while an we are finalizing our general proposals group health plan becomes eligible for important consideration for regarding payments subject to the Medicare because he or she has beneficiaries on dialysis, is not the focus HDPA, without modification. of this Model. developed ESRD, there is a 30-month Comment: A commenter opined that coordination period during which the b. Facility HDPA the payment adjustments proposed for beneficiary’s group health plan remains For ESRD facilities that are ETC the ETC Model are reminiscent of the the primary payer if the beneficiary was Participants, we proposed to adjust ‘‘bonus-and-penalty payment previously insured. During this time, Medicare payments under the ESRD methodology’’ used in the Premier Medicare is the secondary payer for PPS for home dialysis services by the Hospital Quality Incentive these beneficiaries. We proposed to HDPA according to the schedule Demonstration (‘‘Premier’’), launched by apply the HDPA to Medicare as described in the proposed rule and CMS in 2003, which the commenter secondary payer claims because the section IV.C.4.d of this final rule. As initial transition period onto dialysis is described as unsophisticated compared noted in the proposed rule and important for supporting beneficiaries to more recent payment methodologies previously in this final rule, under the in selecting home dialysis, as used in Innovation Center models. The ESRD PPS, a single per treatment beneficiaries who begin dialysis at home commenter further noted that Premier payment is made to an ESRD facility for are more likely to remain on a home did not yield improved patient all renal dialysis services, which modality. As we noted in the proposed outcomes. includes home dialysis services, Response: CMS disagrees with the rule, the HDPA would adjust the furnished to beneficiaries. This payment commenter’s comparison between Medicare payment rate for the initial is subject to a number of adjustments, Premier and the ETC Model. In Premier, claim, and then the standard Medicare including patient-level adjustments, CMS offered high achieving participants Secondary Payer calculation and facility-level adjustments, and, when either a 1 percent or 2 percent positive payment rules would apply, possibly applicable, a training adjustment add-on adjustment on certain claims, and did leading to an adjustment to the for home and self-dialysis modalities, an not incorporate downside risk. While Medicare Secondary Payer amount. We outlier payment, and the TDAPA. We the HDPA may resemble the Premier sought comment on the proposal to explained in the proposed rule that, at payment adjustment, under the ETC apply the HDPA to Medicare as that time, the formula for determining Model the HDPA will be applied secondary payer claims. the final ESRD PPS per treatment concurrently with the PPA, which The following is a summary of the payment amount was as follows: provides both upward and downward comments received on payments subject adjustments to certain payments, and at to the HDPA and our proposal to apply Final ESRD PPS Per Treatment Payment a notably larger magnitude than the the HDPA to claims where Medicare is Amount = (Adjusted ESRD PPS payment adjustments under Premier. a secondary payer, and our responses. Base Rate + Training Add On + After considering public comments, Comment: A commenter expressed TDAPA) * ESRD QIP Factor + we are finalizing our general proposal support for CMS’s proposal to apply the Outlier Payment * ESRD QIP Factor regarding the HDPA, as proposed. We HDPA to all ETC Participants, reasoning We proposed to apply the Facility are also finalizing the proposed that the HDPA incentivizes an increase HDPA to the Adjusted ESRD PPS per definitions for the Home Dialysis in home dialysis rates, which aligns Treatment Base Rate on claims Payment Adjustment (HDPA), Clinician with the Model’s goals. Another submitted for home dialysis services. Home Dialysis Payment Adjustment commenter recommended that CMS For purposes of the ETC Model, we (Clinician HDPA), and Facility Home apply the HDPA to all ESRD providers. proposed to define the ‘‘Adjusted ESRD

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PPS per Treatment Base Rate’’ as the per the entire month of the claim. We commenter’s suggestion that CMS apply treatment payment amount as defined in explained that facility code 7 (the the Facility HDPA to the training add- 42 CFR 413.230, including patient-level second digit of Type of Bill) paired with on payment adjustment, while we agree adjustments and facility-level type of care code 2 (the third digit of with the commenter that beneficiary adjustments, and excluding any Type of Bill), indicates that the claim training is necessary prior to initiating applicable training adjustment add-on occurred at a clinic or hospital-based home dialysis, CMS believes that payment amount, outlier payment ESRD facility. Type of Bill 072X adjusting the Adjusted ESRD PPS per amount, and TDAPA amount. We stated captures all renal dialysis services Treatment Base Rate by the Facility in the proposed rule that the proposed furnished at or through ESRD facilities. HDPA for claims submitted for home formula for determining the final ESRD We stated in the proposed rule that dialysis will provide a sufficient PPS per treatment payment amount condition codes 74 and 75 indicate financial incentive to shift beneficiaries with the Facility HDPA would be as billing for a patient who received to home dialysis. Regarding the follows: dialysis services at home, and condition commenter’s suggestion that CMS Final Per Treatment Payment Amount code 80 indicates billing for a patient should apply the Facility HDPA to the with Facility HDPA = ((Adjusted who received dialysis services at home TDAPA, the commenter discussed drugs ESRD PPS per Treatment Base Rate and the patient’s home is a nursing for which drug sponsors are seeking * Facility HDPA) + Training Add facility. Condition code 76 indicates FDA approval. CMS does not find it On + TDAPA) * ESRD QIP Factor + billing for a patient who dialyzed at appropriate to change its proposed Outlier Payment * ESRD QIP Factor home but received back-up dialysis in a application of the Facility HDPA in facility. We noted in the proposed rule In the proposed rule, we considered anticipation of certain renal dialysis that, taken together, we believed these adjusting the full ESRD PPS per drugs that may or may not be approved condition codes capture home dialysis treatment payment amount by the by the FDA. Further, even if these drugs services furnished by ESRD facilities, Facility HDPA, including any applicable were already approved or become and therefore were the codes we training adjustment add-on payment approved by the FDA during the Model, proposed to use to identify those that would not change CMS’s position, amount, outlier payment amount, and payments subject to the Facility HDPA. as the Model is not focused on drug TDAPA. However, we concluded that We sought comment on this proposed innovation or designed to encourage adjusting these additional payment provision. amounts was not necessary to create the As further described in the proposed pharmaceutical companies to create and financial incentives we seek to test rule and in section IV.C.7.a of this final release more drugs. Rather, the Model is under the proposed ETC Model. We rule, we also proposed that the Facility designed to increase rates of home sought comment on our proposed HDPA would not affect beneficiary cost dialysis and transplantation. definition of Adjusted ESRD PPS per sharing. Beneficiary cost sharing instead While we are not modifying the Treatment Base Rate, and the would be based on the amount that proposed application of the Facility implications of excluding from the would have been paid under the ESRD HDPA, we are updating the formula for definition the adjustments and payment PPS absent the Facility HDPA. calculating the final ESRD PPS per amounts previously listed, such that The following is a summary of the treatment payment amount with the those amounts would not be adjusted by comments received on the Facility Facility HDPA to reflect the addition of the Facility HDPA under the ETC HDPA and our responses. the TPNIES. Because CMS would apply Model. Comment: Many commenters the TPNIES in the calculation of the per As discussed previously in section recommended that CMS adjust the treatment payment amount after the IV.B.1 of this final rule, after we home and self-dialysis training add-on application of the patient-level published the proposed rule for the ETC payment adjustment under the ESRD adjustments and facility-level Model, CMS established a new payment PPS by the Facility HDPA. One such adjustments, in the same manner as the adjustment under the ESRD PPS called commenter opined that the training add- TDAPA, the TPNIES does not alter the the TPNIES, which could apply to on payment adjustment is directly proposed application of the Facility certain claims as soon as CY 2021. The related to the Model’s goal of shifting HDPA. We had proposed to apply the TPNIES is part of the calculation of the beneficiaries to home dialysis Facility HDPA to the Adjusted ESRD ESRD PPS per treatment payment modalities. A commenter recommended PPS per Treatment Base Rate, meaning amount under 42 CFR 413.230 and, like that CMS adjust the TDAPA by the the per treatment payment amount as the TDAPA, is applied after the facility- Facility HDPA, asserting that new renal defined in 42 CFR 413.230, including level and patient-level adjustments. We dialysis drugs and biological products patient-level adjustments and facility- discuss the implications of this change pending FDA approval that could be level adjustments and excluding any for the Facility HDPA later in this furnished to beneficiaries receiving applicable training adjustment add-on section of the final rule. home dialysis services may be found to payment amount, outlier payment In the proposed rule, we proposed in better support implementation of home amount, and TDAPA amount. To take § 512.340 to apply the Facility HDPA to dialysis delivery services. A commenter into account the TPNIES payment the Adjusted ESRD PPS per Treatment expressed support for CMS’s proposal to adjustment that could apply beginning Base Rate on claim lines with Type of exclude the outlier payment from the in CY2021, we are finalizing the formula Bill 072X, where the type of facility definition of the Adjusted ESRD PPS per for determining the final ESRD PPS per code is 7 and the type of care code is Treatment Base Rate. treatment payment amount with the 2, and with condition codes 74, 75, 76, Response: We thank the commenters Facility HDPA, with the TPNIES as or 80, when the claim is submitted by for their feedback. As we stated in the follows: an ESRD facility that is an ETC proposed rule, we believe adjusting the Participant with a claim through date training add-on payment adjustment Final Per Treatment Payment Amount during a CY subject to adjustment, as amount and the TDAPA amount by the with Facility HDPA = ((Adjusted described in the proposed rule and Facility HDPA is not necessary to create ESRD PPS per Treatment Base Rate section IV.C.4.d of this final rule, where the financial incentives we seek to test * Facility HDPA) + Training Add the beneficiary is age 18 or older during under the ETC Model. Regarding the On + TDAPA + TPNIES) * ESRD

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QIP Factor + Outlier Payment * Specifically, we are codifying in our excludes any applicable TPNIES ESRD QIP Factor regulation at § 512.340 that we will amount, with a technical change to Comment: A commenter expressed adjust the Adjusted ESRD PPS per capitalize every word in the term general support for CMS’s proposed Treatment Base Rate by the Facility ‘‘Adjusted ESRD PPS per Treatment approach for identifying home dialysis HDPA for claim lines with Type of Bill Base Rate.’’ services for the purposes of applying the 072X and with condition codes 74 or 76 c. Clinician HDPA Facility HDPA, but recommended that where the claim is submitted by an For Managing Clinicians that are ETC CMS also apply the Facility HDPA to ESRD facility that is an ETC Participant Participants, we proposed to adjust the claims with condition code 73. The with a claim service date during a MCP by the Clinician HDPA when commenter asserted that for calendar year subject to adjustment as billed for home dialysis services. We beneficiaries who qualify for Medicare described in § 512.350, where the proposed to define the ‘‘MCP’’ as the based on ESRD diagnosis, CMS beneficiary is at least 18 years old before monthly capitated payment made for considers Medicare coverage to begin the first day of the month. We are each ESRD Beneficiary to cover all when a beneficiary participates in a modifying which date associated with routine professional services related to home dialysis training program offered the claim we are using to determine if treatment of the patient’s renal by a Medicare-approved training the claim occurred during the condition furnished by a physician or applicable MY. Whereas we proposed facility, and ESRD facilities report such non-physician practitioner as specified using the claim through date, we are home dialysis training using condition in 42 CFR 414.314. We considered finalizing using the date of service on code 73 on claims. Other commenters adjusting all Managing Clinician claims similarly suggested that CMS apply the the claim, to align with Medicare claims for services furnished to ESRD Facility HDPA to claims for home processing standards. Specifically, Beneficiaries, including those not for dialysis-related services with condition while Medicare claims data contains dialysis management services. However, code 73. both claim through dates and dates of as described in the proposed rule, we Response: We thank the commenters service, Medicare claims are processed concluded that adjusting claims for for their feedback. CMS understands based on dates of service. Thus, we services other than dialysis management that condition code 73 relates to training must use the claim date of service to was not necessary to create the financial a beneficiary on home dialysis, and that identify the MY in which the service incentives we seek to test under the ETC one way CMS determines the start of was furnished. In addition, while we Model. Medicare coverage for an ESRD had proposed to apply the Facility We proposed to specify in our Beneficiary is when an ESRD facility HDPA only to claims for which the regulation at § 512.345 that we would bills Medicare using condition code 73 beneficiary was at least 18 years old for adjust the amount otherwise paid under for that beneficiary. However, under the the entire month of the claim, in the Part B with respect to MCP claims by ETC Model, CMS seeks to adjust final rule, we are changing the language the Clinician HDPA when the claim is payments for and incentivize the to state that the beneficiary must be at submitted by a Managing Clinician who provision of home dialysis services, and least 18 years of age ‘‘before the first day is an ETC Participant. MCP claims not home dialysis training per se. CMS of the month,’’ which is easier for CMS would be identified by claim lines with recognizes that training is necessary for to operationalize and has the same CPT® codes 90965 or 90966. We would a beneficiary to succeed in home practical effect (that is, a beneficiary adjust MCP claims with a claim through dialysis; however, adjusting payments who is at least 18 years old before the date during a CY subject to adjustment, for claims that include condition code first date of a month will be at least 18 as described in the proposed rule and 73 may encourage impermissible years old for that entire month). While section IV.C.4.d of this final rule, where ‘‘gaming’’ wherein ETC Participants we proposed to apply the Facility HDPA the beneficiary is 18 years or older for train all beneficiaries on home dialysis, to claims with condition code 75, we the entire month of the claim. CPT® regardless of whether the ETC have since learned that this condition code 90965 is for ESRD-related services Participant believes home dialysis is the code is no longer valid and therefore for home dialysis per full month for most appropriate modality for the will be removed for the final rule. patients 12–19 years of age. CPT® code beneficiary. In such a case, CMS would Additionally, in this final rule, we will 90966 is for ESRD-related services for be compensating ETC Participants for not apply the Facility HDPA to claims home dialysis per full month for simply training beneficiaries, rather with condition code 80, as we had patients 20 years of age and older. These than for starting and maintaining proposed, because condition code 80 two codes are used to bill the MCP for trained Beneficiaries on home dialysis. indicates billing for a patient who patients age 18 and older who dialyze Further, any home dialysis claim received dialysis services at home and at home, and therefore are the codes we submitted for an ESRD Beneficiary after the patient’s home is a nursing facility. proposed to use to identify those the claim containing condition code 73 As described in greater detail in section payments subject to the HDPA. As noted would be adjusted by the Facility IV.C.5.b.(1) of this final rule, we are in the proposed rule and previously in HDPA, providing a robust enough excluding beneficiaries who reside in or this final rule, we proposed to adjust the incentive to ETC Participants to increase receive dialysis services in a SNF or amount otherwise paid under Part B by the provision of home dialysis services. nursing facility from attribution to ETC the Clinician HDPA so that beneficiary Comment: A commenter expressed Participants for purposes of calculating cost sharing would not be affected by support for CMS’s proposal that the the PPA. We will exclude home dialysis the application of the Clinician HDPA. Facility HDPA would not affect claims for these beneficiaries from the The Clinician HDPA would apply only beneficiary cost sharing. application of the Facility HDPA for the to the amount otherwise paid for the Response: We thank the commenter same reason. We are finalizing the MCP absent the Clinician HDPA. for the feedback and support. definition of Adjusted ESRD PPS per The following is a summary of the After considering public comments, Treatment Base Rate in our regulation at comments received on the Clinician we are finalizing our proposed § 512.310 with one modification to HDPA and our responses. provisions on payments subject to the reflect that the Adjusted ESRD PPS per Comment: Two commenters Facility HDPA with modification. Treatment Base Rate calculation expressed support for our proposal that

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the Managing Clinician HDPA would under Medicare Part B with respect to magnitude of the HDPA would decrease not affect beneficiary cost sharing. One MCP claims, identified by claim lines over the years of the ETC Model test, as such commenter reasoned that with CPT® codes 90965 or 90966, by the the magnitude of the PPA increases. In beneficiaries included in the Model Clinician HDPA when the claim is this way, we would transition from should not be financially harmed or submitted by a Managing Clinician who providing additional financial experience perverse incentives to obtain is an ETC Participant and with a claim incentives to support the provision of care not resulting in optimal patient service date during a calendar year home dialysis through the HDPA in the health outcomes. Another commenter subject to adjustment described in initial three CYs of the ETC Model, to expressed concern that CMS did not § 512.350, where the beneficiary is at holding ETC Participants accountable explain in the proposed rule how the least 18 years old before the first day of for attaining the outcomes that the HDPA would impact beneficiary co- the month. As noted elsewhere, we are Model is designed to achieve via the insurance. modifying which date associated with PPA. In the proposed rule, we Response: We thank the commenters the claim we are using to determine if considered alternative durations of the for their feedback. As we noted in the the claim occurred during the HDPA, including limiting the HDPA to proposed rule, the Clinician HDPA is applicable MY. Whereas we proposed applied to the Part B paid amount. using the claim through date, we are one year such that there would be no Beneficiary cost sharing (for example, finalizing using the date of service on overlap between the HPDA and the beneficiary coinsurance) is not subject the claim, to align with Medicare claims PPA, or extending the HDPA for the to the HDPA adjustment. processing standards. Specifically, entire duration of the Model. However, Comment: A commenter suggested while Medicare claims data contains we did not elect to propose these that, during the Model, CMS increase both claim through dates and dates of approaches in the proposed rule. We the payment amount for physicians’ service, Medicare claims are processed explained that if the HDPA applied for services for patients in training for self- based on dates of service. Thus, we only the first year of the Model, there dialysis. must use the claim date of service to would be a six-month gap between the Response: We thank the commenter identify the MY in which the service end of the HDPA (December 31, 2020) for this feedback. CMS disagrees with was furnished. In addition, while we and the start of the first PPA period the commenter’s suggestion that CMS had proposed to apply the Clinician (July 1, 2021), during which there increase the PFS payment amount for HDPA only to claims for which the would be no model-related payment services furnished to patients in training beneficiary was at least 18 years old for adjustment. If the HDPA applied for the for self-dialysis, as (1) the Model uses the entire month of the claim, in the duration of the Model, there would be percentages for its payment adjustments final rule, we are changing the language two sets of incentives in effect: A to give each ETC Participant a to state that the beneficiary must be at process-based incentive from the HDPA percentage (rather than flat-dollar) least 18 years ‘‘before the first day of the and an outcomes-based incentive from increase or decrease in payment, and (2) month,’’ which is easier for CMS to the home dialysis component of the CMS has modified its proposal to operationalize and has the same PPA. As we explained in the proposed include self-dialysis services for practical effect (that is, a beneficiary rule, while we believe that the time- purposes of calculating the home who is at least 18 years old before the limited overlap between the two dialysis rate, as described in section first date of a month will be at least 18 payment adjustments is acceptable to IV.C.5.c.(1) of this final rule. years old for that entire month). Finally, smoothly transition ETC Participants After considering public comments, we are finalizing the definition of we are finalizing our proposals on the from process-based incentives to Monthly capitation payment (MCP), as outcomes-based incentives, we do not application of the Clinician HDPA to proposed, in our regulation at § 512.310. MCP claims with modifications. believe this structure is beneficial to the Specifically, we are codifying in our d. HDPA Schedule and Magnitude Model test over the long term. regulation at § 512.345 that we will We proposed to specify in our We proposed the payment adjustment adjust the amount that is otherwise paid regulations at § 512.350 that the schedule in Table 11:

Under this proposed schedule, the HDPA schedule and magnitude and our applied be increased from 3 years to 4 HDPA would no longer apply to claims responses. years. Several commenters expressed submitted by ETC Participants with Comment: Several commenters concern regarding the proposal to claim through dates on or after January recommended that we continue to apply reduce the magnitude of the HDPA after 1, 2023. We sought input from the the HDPA beyond the first 3 years of the the first year, and otherwise taper down public about the proposed magnitude Model, and some suggested that we the magnitude of the HDPA over the and duration of the proposed HDPA. continue to apply the HDPA for the course of the first three years of the The following is a summary of the entire duration of the Model. A Model. Commenters also expressed comments received on the proposed commenter recommended that the concern regarding the proposal to apply period during which the HDPA is the HDPA during only the first three

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years of the Model. Several commenters beneficiary has been on home dialysis the uptake of home dialysis may be expressed concern that building up the for 3 months, CMS believes it is slower than CMS anticipates, and thus infrastructure necessary to increase the important to apply the HDPA sooner so suggested that CMS consider provision of home dialysis will take as to better position ETC Participants to implementing a performance benchmark time, and that it would be more immediately begin making investments that an ETC Participant must reach appropriate to apply the HDPA to to increase the provision of home before CMS lowers the magnitude of claims submitted by ETC Participants dialysis to beneficiaries for whom this that ETC Participant’s HDPA. The same for more years of the Model. Some modality is clinically appropriate. CMS commenter also recommended that the commenters explained that the sources also appreciates the commenter’s duration of the HDPA should be of delay and difficulty in establishing or concern over the possibility of ETC different for LDOs versus non-LDOs, building upon a home dialysis program Participants gaming the HDPA when the such that the HDPA would apply to include: Capital investments; hiring HDPA applies immediately and not after claims submitted by non-LDOs for a staff, particularly dialysis nurses who a particular ESRD Beneficiary has been longer period of time than for claims are in short supply across the nation; on home dialysis for a certain amount submitted by LDOs, or that the receiving local zoning and building of time, but CMS believes the overall magnitude of the HDPA applied to permits; and obtaining federal and state payment methodology under the Model claims submitted by non-LDOs would regulatory approval. Commenters eliminates a gaming incentive of this taper down more slowly than it would expressed concern that going through nature. Part of the calculation for the for the LDOs. Several commenters the required processes and obtaining the PPA derives from the ETC Participant expressed concern that the Facility appropriate equipment and staffing can showing improvement in its home HDPA and Clinician HDPA adjustments easily take a year or more, at which time dialysis rate in a given year. An ETC are too low to adequately incentivize the magnitude of the HDPA will have Participant will need to increase its behavioral change. already decreased. beneficiary population receiving home Response: We appreciate the Response: Regarding the comments dialysis in a sustainable fashion for its commenters’ feedback. CMS does not recommending that CMS extend the data to reflect an improvement, creating believe it would be beneficial to the duration of time during which the an incentive for ETC Participants to Model to require a performance HDPA would be applied, CMS indicated identify suitable candidates for home benchmark for an ETC Participant to in the proposed rule that applying the dialysis and to keep such candidates on reach before CMS decreases the HDPA for the duration of the Model home dialysis over the course of months magnitude of the Participant’s HDPA, as would create an overlap between a and years, as appropriate. the intent of the HDPA is to incentivize payment adjustment that is process- Comment: Some commenters investments in home dialysis in the based, the HDPA, and another that is expressed general support for the early years of the Model. In later years, outcomes-based, the PPA, that would magnitude of the HDPA as proposed. A such incentives would be created by the not be beneficial to the Model test over few commenters expressed agreement application of the PPA. CMS also the long-term. Applying the HDPA for with the idea that payment incentives disagrees with the recommendation that another year would similarly not be have a role in achieving higher value CMS differentiate the duration or beneficial to the Model over the long- care for kidney patients. One such magnitude of the HDPA between LDOs term. The Model is designed to more commenter noted that rates of PD have and non-LDOs, as such a distinction heavily emphasize, in the beginning of increased due to aligning the fails to consider differences in current the Model, the process of building up reimbursement for in-center dialysis home dialysis service provision across necessary infrastructure to provide more with home-based modalities. Similarly, LDOs and non-LDOs. CMS believes that home dialysis services, and to more another such commenter noted that the HDPA and PPA, in combination, heavily emphasize, in later years of the ESRD facilities have proven remarkably provide an equally strong incentive to Model, the outcomes of increased home responsive to policy changes that are LDOs and non-LDOs alike toward dialysis and transplants. CMS tied to payment adjustments, such as establishing or building out home recognizes that building the necessary the ESRD PPS and ESRD QIP initiatives. dialysis programs. Further, to the extent infrastructure will take time, and that is That same commenter expressed a belief that the HDPA will result in a greater why CMS proposed to apply the HDPA that the payment adjustments under the revenue increase to LDOs over non- for the first three years of the Model. ETC Model are far milder than the ESRD LDOs early in the Model, such a CMS believes that three years is more PPS and QIP initiatives, and expressed disparity is appropriate given the larger than enough time to take all necessary confidence that Managing Clinicians volume of patients that LDOs, by steps to increase utilization of home and ESRD facilities that are ETC definition, serve. An ESRD facility dialysis. Participants will quickly adopt new furnishing services to a larger volume of Comment: A commenter treatment and process innovations to patients will require a larger investment recommended that CMS wait to apply maximize their performance within the in infrastructure compared to an ESRD the HDPA to claims submitted by an Model. facility furnishing services to a smaller ETC Participant until after a patient has Response: We thank the commenters volume of patients. CMS further been on home dialysis for three months. for the feedback and support. We also believes that the magnitude of the The same commenter expressed concern appreciate the comment regarding the Facility HDPA and Clinician HDPA, that ETC Participants will start patients increase in the provision of PD, but note especially when coupled with the on home dialysis who will not do well that the ESRD PPS base payment rate is respective PPAs, are adequate to on home dialysis so that the ETC modality neutral, and that the identified incentivize ETC Participants to create or Participants could potentially receive a increase in rates of PD could be build out their home dialysis programs. short-term increase in payment via the explained by a higher profit margin for Comment: Many commenters noted application of the HDPA. providing PD over HD, and not because that establishing a home dialysis Response: While CMS appreciates the the Medicare payment is higher. program or building upon an existing commenter’s suggestion that CMS wait Comment: A commenter expressed program requires hiring and training to apply the HDPA to claims submitted support for the proposed magnitude of staff, particularly dialysis nurses, who by an ETC Participant until the the HDPA, but expressed concern that several commenters noted are in short

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supply; securing additional space and that chain ESRD facilities have over proposed Clinician HDPA of 3 percent equipment; establishing training others. Moreover, we believe that non- still leaves the payment amount for protocols for patients; undergoing a chain ESRD facilities can innovate their home dialysis services below the in- survey and certification process business practices to overcome the center MCP payment for four or more (depending on the State); obtaining identified advantage that chain ESRD visits during a month. zoning and building permits; and facilities currently have. For example, Response: CMS recognizes that for obtaining federal and State regulatory non-chain ESRD facilities could hire a physicians, the MCP for in-center approval. Commenters stated that the part-time nurse rather than a full-time dialysis is currently higher than the magnitude of the HDPA is not large nurse, or collaborate with other nearby MCP for home dialysis. However, CMS enough to cover these significant up- non-chain ESRD facilities to contract firmly believes that moving front costs. Other commenters expressed with a nurse to mimic the approach that beneficiaries to home dialysis will concern that the HDPA would prove the commenter anticipates chain ESRD ultimately be cost saving for ETC inadequate to help small and facilities will take. Regarding the Participants by the end of the model independent ESRD facilities increase comments expressing concern that CMS period and that the Clinician HDPA their provision of home dialysis, as such did not quantify the investment adjustments, as proposed, are facilities often have low margins and required by ESRD facilities and sufficiently large to encourage ETC fewer resources than LDOs. A Managing Clinicians to establish or Participants create or build out home commenter expressed concern that the build upon home dialysis programs, dialysis programs to realize those long HDPA would favor chain ESRD facilities CMS could not have adequately term savings. The infrastructure and with several ESRD facilities within close quantified such investments for all ETC equipment necessary for providing proximity who can hire one dialysis Participants. ESRD facilities and home dialysis may be expensive up- nurse to cover multiple ESRD facilities, Managing Clinicians are heterogeneous, front, but once the infrastructure and and will lead smaller health care and costs will differ greatly among equipment have been acquired, home providers to sell their facility to large ESRD facilities and Managing dialysis will be less costly for the ETC chain ESRD facilities, causing further Clinicians. Regional differences in cost, Participant to provide compared to consolidation. Still other commenters differing patient population sizes, providing four or more in-center expressed concern that CMS did not differing relationships with community dialysis sessions. Even though the attempt to quantify the investment partners, and differences in margins, Clinician HDPA is not large enough to required by ESRD facilities and funding, and business models make it make payment for providing home Managing Clinicians to establish or impossible for CMS to accurately dialysis equal to or higher than payment build upon home dialysis programs, identify the cost of creating or building for providing four or more in-center which those commenters believed upon a home dialysis program for each dialysis sessions, it is large enough to should have informed the proposed ESRD facility or Managing Clinician. sufficiently lessen the up-front costs of magnitude and duration of the HDPA. A The HDPA will provide ETC establishing or building out home commenter expressed concern that CMS Participants with upfront revenue that dialysis capability and allow the ETC did not indicate, in the proposed rule, the ETC Participant can use to increase Participant to realize the benefits that the HDPA as proposed would be provision of home dialysis. associated with moving appropriate ESRD Beneficiaries away from in-center adequate to allow ETC Participants to Comment: Several commenters services to home dialysis. For ETC increase their capacity to provide home expressed concern that the Clinician Participants, these benefits may include: dialysis services. HDPA, as proposed, is too small in Reduced labor costs and capital Response: CMS believes that amount to effectively address the depreciation associated with reduced providing positive payment adjustments current gap in reimbursement between provision of in-center services; the via the HDPA over the first three years providing in-center dialysis compared capacity to increase the total number of of the Model will provide sufficient to home dialysis. Several commenters patients served at any given time and time for ETC Participants to build out expressed concern that even with the 3 overall given that fewer patients will infrastructure to establish or build upon percent HDPA, Managing Clinicians are use in-center space, which can only home dialysis programs. CMS still paid more under current Medicare accommodate so many patients at any recognizes that market realities impose rules for providing four or more in- one time, allowing the ETC Participant significant barriers to increasing center dialysis treatments a month than to more rapidly expand the patient capacity to offer home dialysis for providing home dialysis in a month. population it serves; and generally programs, which is exactly why CMS Noting that CMS acknowledged in the decreased operating costs in the proposed to apply the HDPA. While proposed rule that current Medicare medium- and long-run. For ESRD CMS cannot easily affect the supply of payment rates and mechanisms may Beneficiaries, the benefits may include dialysis nurses or the number of create a disincentive to prescribe and reduced or eliminated commuting to vendors in the home dialysis market, it furnish home dialysis, the commenters ESRD facilities for treatment, greater can provide ETC Participants with suggested the HDPA for Managing involvement in the ESRD Beneficiary’s positive payment adjustments through Clinicians should be set at a magnitude own treatment, and generally greater the HDPA to help overcome these such that the Clinician HDPA plus the autonomy. market obstacles. Regarding the MCP for home dialysis exceeds the Comment: Several commenters commenter’s concern about chain ESRD current MCP for four or more in-center recommended that the HDPA be facilities that have several clinics in dialysis visits in a given month. The increased in magnitude. Some of these close proximity being able to hire one same commenters recommended that commenters recommended that the nurse to cover multiple ESRD facilities, following the end of the proposed magnitude of the HDPA be increased such ESRD facilities would have that HDPA period, CMS should include a significantly. Some commenters advantage regardless of the payment payment adjustment to the MCP that suggested certain specific amounts for adjustments made under this Model. equalizes the MCP for home dialysis the HDPA. A few commenters The ETC payment methodology does and the MCP for four or more in-center recommended that the magnitude of the not create or increase this advantage visits. A commenter stated that the HDPA be increased to 3–5 percent.

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Other commenters suggested that the impact on home dialysis rates when beyond what was proposed would magnitude of the HDPA stay at 3 combined with the PPA, given that the undercut the focus on outcomes under percent for all three years it is applied, PPA could impose a large downward the Model. or that it remain at 3 percent for the adjustment on certain payments for ETC After considering public comments, duration of the Model. Another Participants. we are finalizing our proposed commenter recommended that the Response: CMS does not believe the provisions on the HDPA schedule and HDPA be maintained at 3 percent for all magnitude of the HDPA needs to be magnitude, with one modification. three years, but alternatively suggested increased. Increasing the HDPA by any Specifically, in order to accommodate that the magnitude of the HDPA start at amount, including maintaining the the start date for the payment 1 percent in year one, increase to 2 HDPA at 3 percent for two additional adjustments under the ETC Model percent in year 2, and to 3 percent in years or for the duration of the Model, finalized in our regulations at § 512.320, year three. Another commenter more would serve to undermine the Model’s we are codifying in our regulations at generally suggested that the HDPA be emphasis on improving outcomes. CMS § 512.350 that CMS adjusts the established at a set amount for every believes that the proposed magnitude of payments specified in § 512.340 by the year of the Model and not be tapered the HDPA will be adequate to make an Facility HDPA and that CMS adjusts the down in magnitude, as proposed. Some impact on home dialysis rates payments specified in § 512.345 by the commenters expressed concern that the notwithstanding the PPA, and that Clinician HDPA according to the HDPA would be too small to make an increasing the magnitude of the HDPA schedule in Table 11.a:

5. Performance Payment Adjustment Participant based on the ESRD facility’s but not over the actual transplant rates. We proposed to adjust payment for MPS, as described in § 512.375(a) Some commenters suggested that CMS claims for dialysis services and dialysis- (Payments Subject to Adjustment) and simply eliminate the transplant rate related services submitted by ETC § 512.380 (PPA Amounts and Schedule). from the PPA calculation. Some Participants based on each ETC We proposed to define the ‘‘PPA’’ as commenters suggested that though Participant’s Modality Performance either the Facility PPA or the Clinician organ supply is outside of the control of Score (MPS), calculated as described in PPA. ESRD facilities and managing clinicians, the proposed rule and section IV.C.5.d The following is a summary of the there are other aspects of the process of this final rule. We proposed to define comments received on the calculation of that can and should be in their control the ‘‘Modality Performance Score the proposed PPA, and in particular the such as how they educate patients and (MPS)’’ as the numeric performance inclusion of the transplant rate in the families about living donation and how score calculated for each ETC MPS used to calculate the PPA, and our effectively they interact with transplant Participant based on the ETC responses. centers. They remarked that there is an Participant’s home dialysis rate and Comment: Several commenters opportunity for ESRD facilities and transplant rate, as described in expressed concern about the level of managing clinicians to increase care § 512.370(d) (Modality Performance control ETC Participants have over coordination and patient education with Score), which is used to determine the transplants. Commenters expressed respect to living donor transplantation. amount of the ETC Participant’s PPA, as concern that the average waitlist stay for A commenter expressed concern about described in § 512.380 (PPA Amounts a patient is around 4.6 years, and the calculation of the MPS, asserting and Schedule). We sought comment on therefore ETC Participants may not be that the proposed home dialysis rate the composition of the MPS, able to receive credit for a transplant and transplant rate calculations, risk particularly the inclusion of the that results from getting a beneficiary on adjustments, reliability adjustments, transplant rate in the MPS. the transplant waitlist given the Model’s and comparison benchmarks seem We proposed that there would be two duration. A commenter recommended complex and would make it difficult for types of PPAs: The Clinician PPA and that we delay the inclusion of the ETC Participants to monitor, gauge, and the Facility PPA. We proposed to define transplant rate in the calculation of the ultimately improve performance. the ‘‘Clinician PPA’’ as the payment PPA until there are system-wide Response: We thank the commenters adjustment to the MCP for a Managing improvements in the availability of for their feedback. CMS believes that Clinician who is an ETC Participant organs for transplant, the transplant rate using a performance measure related to based on the Managing Clinician’s MPS, is redesigned to enhance patient transplants to determine, in part, an as described in our regulations at protections, and the Model explicitly ETC Participant’s PPA is vital to incent § 512.375(b) (Payments Subject to accounts for regional variation in meaningful behavior change. While Adjustment) and § 512.380 (PPA transplant rates. Several commenters CMS does recognize that ETC Amounts and Schedule). We proposed recommended that CMS use transplant Participants, as ESRD facilities and to define the ‘‘Facility PPA’’ as the waitlisting instead of actual transplant Managing Clinicians, do not have payment adjustment to the Adjusted rates in calculating the PPA, noting that control over every step of the transplant ESRD PPS per Treatment Base Rate for ESRD facilities and Managing Clinicians process, CMS continues to believe it is an ESRD facility that is an ETC have influence over waitlisting rates, appropriate to include a transplant

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component in the MPS calculation used waitlisting while implementing other navigate the transplant process, to determine the PPA. As the health care policies to increase the supply of including helping beneficiaries providers that ESRD beneficiaries see available deceased donor kidneys. understand the process; providing most frequently, ETC Participants play a These modifications to the transplant referrals for care necessary to meet pivotal role in the transplant process, component of the MPS calculation is clinical transplant requirements, and including: Educating beneficiaries about further discussed in section IV.C.5.c.(2) referrals for transplant waitlisting; and their transplant options, including of this final rule. coordinating care during the transplant living donation; helping beneficiaries CMS recognizes that 88.5% of all process. navigate the transplant process, deceased donor kidney transplants Comment: Some commenters including helping beneficiaries occurred among patients who had been recommended that CMS create a understand the process; providing on the waitlist for less than five years. blended home dialysis-transplant referrals for care necessary to meet Given that the ETC Model will last over measure for determining an ETC clinical transplant requirements, and 5 years, the average Medicare Participant’s PPA. For example, one referrals for transplant waitlisting; and beneficiary placed on a waitlist in the commenter suggested using a composite coordinating care during the transplant first year is expected to receive a endpoint, where home dialysis and process. transplant by the end of the Model. transplantation are measured in one Based on feedback from commenters, Accordingly, CMS may consider rate, rather than two separate rates, however, CMS is drawing a distinction incorporating a transplant rate into the using the same numerator and between living donor transplants, which PPA calculation for later years of the denominator. Another commenter are not subject to the same supply Model through subsequent rulemaking. suggested including an appropriate constraints brought up by commenters, Comment: Commenters expressed a patient acuity measure and measures and deceased donor transplants, which desire for other stakeholders like OPOs that assess social determinants of health currently have a more limited supply. to also be held financially accountable and unmet social needs in calculating For the living donation process, CMS for transplant rates under the Model if the home dialysis and transplant rates recognizes the important role that ETC CMS is going to proceed with holding and issuing the PPA. Participants have in helping inform and ETC Participants financially Response: We appreciate the support their patients in the living accountable for actual transplants. One commenter’s suggestion that we create a donor process, and will therefore retain such commenter expressed concern that blended home dialysis and transplant the living donor transplant rate in the ETC Participants may be unfairly rate to determine an ETC Participant’s transplant rate calculation. disadvantaged if a transplant program PPA and recognize that some ETC In contrast, CMS recognizes that the does not put higher risk patients Participants may excel at supporting current process for deceased donor referred by the ETC Participant on the beneficiaries in selecting one alternative organ allocation and the current transplant waitlist that other transplant to in-center HD and not the other. shortage of available deceased donor programs might accept. However, we believe it is important that kidneys makes it difficult to hold ETC Response: As discussed in response to ESRD Beneficiaries receive the support Participants accountable for the rate of the preceding comment and as they need to select either home dialysis deceased donor kidney transplants at described in section IV.C.5.d of this or transplantation, regardless of the ETC this time. The proposed rule calculated final rule, we will not be holding ETC Participant from which they receive the transplant rate by adding together all Participants accountable for deceased dialysis care. As such, we believe it is transplants, including pre-emptive donor transplants under the ETC Model. important to assess ETC Participant transplants. However, based on Rather, we will use a transplant rate performance on the home dialysis rate feedback from commenters the rate of calculated as the sum of the transplant and transplant rate separately, rather deceased donor transplants will not be waitlist rate and the living donor than using a blended approach. a part of the transplant rate calculation. transplant rate for purposes of the Comment: A commenter The transplant rate will still include transplant component of the MPS. recommended that CMS provide an living donor transplants, including Regarding the concern that ETC increased payment to dialysis providers preemptive transplants, but we replaced Participants may be unfairly for transplants as part of the ETC Model, the deceased donor transplants in the disadvantaged if a transplant program similar to the transplant bonus payment transplant rate calculation with the does not put higher risk patients in the KCC Model. transplant waitlist rate because CMS referred by ETC Participants on the Response: CMS disagrees with the also recognizes that ESRD facilities and transplant waitlist that other transplant commenter’s suggestion to provide ETC Managing Clinicians play an essential programs might accept, CMS Participants with a bonus payment for role in supporting beneficiaries in acknowledges that transplant programs transplants, as ETC Participants can selecting transplantation and referring have different criteria for accepting receive such a bonus by participating beneficiaries to a transplant waitlist, patients on transplant waitlists. ETC concurrently in the KCC Model. and are well-positioned to work with Participants can work with transplant Comment: A commenter suggested OPOs and transplant centers to further programs in their respective that CMS adjust payment to ESRD increase transplant waitlisting. The ETC communities to encourage the facilities using performance data on Model is designed in part to encourage acceptance of a particular ESRD quality measures that facilities have health care providers to form these Beneficiary on the waitlist. ETC publicly reported for a period of time relationships. The ETC Learning Participants could also recommend that because that would allow stakeholders Collaborative, described in section their patients register with a particular to assess the reliability and validity of IV.C.13 of this final rule, is designed to transplant program that accepts patients the measures, as well as the proposed facilitate these relationships as part of with their levels of risk. ETC scoring methodology, and to identify the dissemination of best practices to Participants can also support ESRD any potential unintended consequences increase organ recovery and utilization. Beneficiaries pursuing living donor that may be occurring. We therefore agree with commenters transplants by educating beneficiaries Response: CMS disagrees with the that it is appropriate to hold ETC about their transplant options, including comment regarding deriving Participants accountable for transplant living donation; helping beneficiaries performance-based quality adjustments

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for ESRD facilities under the ETC Model using in-center dialysis. The same of the home dialysis and transplant from previously publicly reported commenter therefore also suggested rates. However, this Model is designed measures. CMS understands the using decision-making tools for the to improve or maintain quality while commenter’s assertion that measures ESRD population, such as the decreasing costs by creating incentives that have been in use for some time and Empowering Patients on Choices for for Managing Clinicians and ESRD have been publicly reported Renal Replacement Therapy (EPOCH). facilities to increase rates of home demonstrate reliability, validity, and Some commenters offered to work with dialysis and transplants. We believe that transparency to stakeholders. However, CMS to construct a shared-decision the proposed rates, with the the home dialysis rate and transplant making measure to supplement the modifications described elsewhere in rate used in the ETC Model are part of proposed home dialysis rate and this final rule, best accomplish this goal. the model test, and have been transplant rate to assess the performance Further, to the extent that supportive constructed solely for the purposes of of ETC Participants under the Model care services result in beneficiaries the model test. For the purposes of and would also protect a beneficiary’s initiating home dialysis, receiving a testing this Model, we do not believe choice and patient protections. living donor transplant, or being that it is necessary for these rates to Response: CMS appreciates the included on the kidney transplant have been publicly reported in advance feedback to include measures of shared waitlist, their use will be indirectly of the Model. As described in section decision making so that beneficiaries counted towards the calculation of the IV.C.10 of this final rule, we will have a choice in dialysis treatment home dialysis rate or the transplant rate, monitor for unintended consequences modality. CMS believes that the respectively. and make modifications to the Model, informational material required to be Comment: A commenter including the home dialysis rate and posted in the facility, described in recommended that CMS include kidney transplant rate, if necessary, through § 512.330(a), addresses the need for transplants with any other organ, and subsequent rulemaking. beneficiaries to be educated about the not just with pancreas. Comment: Many commenters Model and the beneficiary protections Response: We appreciate the recommended that CMS use validated described in section II of this final rule commenter’s feedback. We are clarifying measures that are endorsed by the adequately protect beneficiaries’ that, in referring to a kidney transplant National Quality Forum (NQF). freedom of choice. While education in the proposed rule, we intended to Response: We appreciate the feedback regarding treatment modality is refer to kidney transplants alone or in from commenters that CMS should use important, CMS will not adopt this conjunction with any other organ NQF-endorsed measures to measure recommendation as it does not fit with transplant. By referring to both kidney ETC Participant performance under the the Model’s goals of adjusting payments transplants and kidney-pancreas Model. We note that, at present, there in order to improve or maintain quality transplants, our intent was not to are no NQF-endorsed measures for rates while reducing costs through increased exclude kidney transplants in of home dialysis, kidney transplants, or rates of home dialysis use, ultimately, conjunction with organs other than the inclusion on the kidney transplant and kidney transplants. pancreas. Accordingly, we are defining waitlist. However, we believe that it is Comment: A commenter the term ‘‘kidney transplant’’ in our appropriate to use the rates constructed recommended that CMS define a regulations at § 512.310 to mean the a specifically for the purposes of this pathway of supportive care services and kidney transplant, alone or in Model, as our intent is to measure the allow beneficiaries enrolled in the conjunction with any other organ. impact of the Model’s payment pathway be included in calculation of Accordingly, the transplant waitlist rate adjustments on the rates of home the proposed home dialysis rate and calculation included in the transplant dialysis and transplants. Given the transplant rate. According to the rate will include ESRD Beneficiaries tailored nature of the home dialysis and commenter, supportive care services listed on a waitlist for any kind of transplant rates and the lack of extant include medical management, defined kidney transplant, and the living donor alternatives, we believe it is appropriate as planned, holistic, person-centered transplant rate calculation included in to use these rates for this Model. care such as interventions to delay the transplant rate will include Comment: A commenter progression of kidney disease and beneficiaries who receive any kind of recommended that CMS add shared minimize risk of adverse events or kidney transplant from a living donor. decision-making measures (that is, complications; shared decision making; Comment: A commenter expressed measures demonstrating that a patient active symptom management; detailed concern about a proposed measure in and clinician made treatment decisions communication including advance care ESRD QIP—the Percentage of Prevalent together based on what is best for the planning; psychological support; as well Patients Waitlisted Measure—that, if patient), such as the Decision Conflict as social and family support. The same finalized, may subject an ETC Scale or those shared decision-making commenter similarly recommended that Participant to a second source of measures in NQF’s National Quality CMS explicitly acknowledge, in the negative payment adjustment. Response: We note that CMS finalized Partners PlaybookTM Shared Decision final rule, the need for supportive care the adoption of the PPPW measure in Making in Healthcare. The same services for seriously ill beneficiaries the CY 2019 ESRD PPS final rule (83 FR commenter noted that the Consumer with CKD Stage IV, CKD Stage V, and 57008). We appreciate the commenter’s Assessment of Healthcare Providers and ESRD. Response: We agree with the concern that ESRD facilities that are Systems (CAHPS) survey for In-Center commenter that supportive care services ETC Participants will receive more than Hemodialysis (ICH CAHPS) 150 includes are important for seriously ill one payment adjustment based on questions related to home modality beneficiaries with CKD Stage IV, CKD transplant waitlisting. However, we options and transplantation, but does Stage V, and ESRD. CMS also believe that the adjustments under the not include shared-decision making appreciates the commenter’s ESRD QIP and the ETC Model are questions and is limited to beneficiaries recommendation that CMS define a sufficiently different, in construction, 150 CAHPS® is a registered trademark of the pathway of supportive care services and payment adjustment scope and Agency for Health Research and Quality, U.S. allow beneficiaries enrolled in such magnitude, and purpose, to support the Department of Health and Human Services. pathway to count toward the calculation overlap.

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After considering public comments, a. Annual Schedule of Performance included in the ETC Model and its we are finalizing our general proposals Assessment and PPA corresponding PPA Period would be for the Performance Payment We proposed to assess ETC specified in § 512.355(c) (Measurement Adjustment, with certain modifications. Participant performance on the home Years and Performance Payment Specific provisions and modifications dialysis rate and the transplant rate, Adjustment Periods). are described in the following sections described in the proposed rule and in Under our proposal, each MY would of this final rule. We received no public sections IV.C.5.c.1 and IV.C.5.c.2, overlap with the subsequent MY, if any, comment on our proposed definitions of respectively, of this final rule, and to for a period of 6 months, as ETC the Performance Payment Adjustment make corresponding payment Participant performance would be (PPA), Facility Performance Payment adjustments according to the proposed assessed and payment adjustments Adjustment (Facility PPA), or Clinician schedule described later. We proposed would be updated by CMS on a rolling Performance Payment Adjustment in § 512.355(a) that we would assess the basis. As we noted in the proposed rule, (Clinician PPA). As such, we are home dialysis rate and transplant rate we believe that this method of making finalizing these definitions in our for each ETC Participant during each of rolling performance assessments regulation at § 512.310 as proposed. We the Measurement Years, which would balances two important factors: The received no public comment on our include 12 months of performance data. need for sufficient data to produce For the ETC Model, we proposed to proposed definition of the Modality reliable estimates of performance, and define ‘‘Measurement Year (MY)’’ as the Performance Score (MPS), and are the effectiveness of incentives that are 12-month period for which achievement proximate to the period for which finalizing this definition in our and improvement on the home dialysis performance is assessed. Beginning with regulation at § 512.310 with rate and transplant rate are assessed for MY2, there would be a 6-month period modification to correct an error in an the purpose of calculating the ETC of overlap between a MY and the internal cross-reference. Specifically, Participant’s MPS and corresponding previous MY. For example, MY1 would the proposed definition of MPS referred PPA. Further, we proposed in to § 512.310(a) of our regulations, but § 512.355(b) that we would adjust begin January 1, 2020, and would run we had meant to refer to the MPS payments for ETC Participants by the through December 31, 2020; and MY2 calculation in § 512.310(d). We are PPA during each of the PPA periods, would begin 6 months later, running adding a definition for ‘‘kidney each of which would correspond to a from July 1, 2020, through June 30, transplant waitlist’’ to our regulations at Measurement Year. We proposed to 2021. Each MY would have a § 512.310, for the reasons described in define ‘‘Performance Payment corresponding PPA Period, which section IV.C.5.c(2) of this final rule. Adjustment Period (PPA Period)’’ as the would begin 6 months after the 6-month period during which a PPA is conclusion of the MY. applied pursuant to § 512.380 (PPA Table 12, we proposed the following Amounts and Schedule). Each MY schedule of MYs and PPA Periods:

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We received no public comment on schedule of MYs and PPA Periods in the purpose of calculating the ETC our proposed schedule of performance Table 12.a, to accommodate the start Participant’s MPS and corresponding assessment and PPA. We are finalizing date for the payment adjustments under PPA. Each MY included in the ETC the proposed provisions with the ETC Model finalized in our Model and its corresponding PPA modification to reflect the start date of regulations at § 512.320. As such, we are Period are specified in § 512.355(c). We the model, January 1, 2021, as described finalizing the definition of MY as the are finalizing the definition of elsewhere in this final rule. Specifically, 12-month period for which achievement Performance Payment Adjustment we are codifying at § 512.355 that the and improvement on the home dialysis Period (PPA Period), as proposed. PPA will be applied based on the rate and transplant rate are assessed for

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b. Beneficiary Population and ‘‘pre-emptive transplant beneficiary’’ as incentivize Managing Clinicians to Attribution a Medicare beneficiary who received a support kidney transplants via the kidney or kidney-pancreas transplant Clinician PPA. Due to data limitations We proposed that, in order to assess prior to beginning dialysis. We stated about patients who are not Medicare the home dialysis rate and transplant beneficiaries, however, we concluded rate for ETC Participants, ESRD that this definition would be mutually exclusive of the proposed definition of that we could not include patients who Beneficiaries would be attributed to received pre-emptive transplants but participating ESRD facilities and to an ESRD Beneficiary, as a pre-emptive transplant beneficiary receives a kidney were not Medicare beneficiaries in the participating Managing Clinicians. For construction of the transplant rate. purposes of the ETC Model, we or kidney-pancreas transplant prior to initiating dialysis and therefore is not an Therefore, we proposed to limit the proposed to define ‘‘ESRD Beneficiary’’ definition of pre-emptive transplant as a beneficiary receiving dialysis or ESRD Beneficiary. In the proposed rule, we considered defining this concept as beneficiary to include Medicare other services for end-stage renal beneficiaries only. disease, up to and including the month pre-emptive transplant recipients, as We proposed to attribute ESRD in which he or she receives a kidney or there are patients who receive pre- Beneficiaries and pre-emptive kidney-pancreas transplant. As we emptive transplants who are not transplant beneficiaries, where noted in the proposed rule, this would Medicare beneficiaries, but who would applicable, to ETC Participants for each include beneficiaries who are on have become eligible for Medicare if month of each MY, and we further dialysis for treatment of ESRD, as well they did not receive a pre-emptive proposed that such attribution would be as beneficiaries who were on dialysis for transplant and progressed to ESRD, made after the end of each MY. In the treatment of ESRD and received a requiring dialysis. We noted that this proposed rule, we considered kidney or kidney-pancreas transplant up definition would more accurately reflect attributing beneficiaries to participating to and including the month in which the total number of transplants ESRD facilities and Managing Clinicians they received their transplant. occurring in the population of patients for the entire MY; however, as noted in Also, we proposed to attribute pre- who could receive pre-emptive the proposed rule, we believe monthly emptive transplant beneficiaries to transplants, and including these attribution would more accurately Managing Clinicians for purposes of additional patients who receive pre- capture the care relationship between calculating the transplant rate, emptive transplants in the calculation of beneficiaries and their ESRD providers specifically. We proposed to define a the transplant rate could better and suppliers. As ETC Participant

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behavior and care relationships with MY, prospective lists of attributed transplant will be considered to be an beneficiaries may change as a result of beneficiaries that attempted to simulate ESRD Beneficiary if the beneficiary the ETC Model, we stated in the which beneficiaries would be attributed either has a non-AKI dialysis or MCP proposed rule that we believe that the to a participant during the MY would be claim at least 12 months after the level of precision associated with potentially misleading. Additionally, we beneficiary’s latest transplant date, or monthly attribution of beneficiaries noted in the proposed rule that, as the has a non-AKI dialysis or MCP claim would better support the ETC Model’s calculation of the home dialysis rate and less than 12 months after the design. Under our proposal, an ESRD transplant rate among attributed beneficiary’s latest transplant date and Beneficiary may be attributed to beneficiaries would be conducted only has a kidney transplant failure diagnosis multiple ESRD facilities and Managing once every 6 months due to overlapping code documented in any Medicare Clinicians in one MY, but would be MYs, we believe providing lists after the claim. We are making this clarification attributed to only one ESRD facility and MY would provide ETC Participants because, while beneficiaries are one Managing Clinician for a given sufficient information about their excluded from the ESRD Beneficiary month during the MY. As we stated in attributed beneficiary populations to definition beginning the month after the the proposed rule, we believe that understand the basis of their rates of beneficiary receives a kidney transplant, conducting attribution retrospectively, home dialysis and transplants. it was our intent that any beneficiary after the completion of the MY, would The following is a summary of the receiving dialysis or other services for better align with the design of the PPA comments received on beneficiary ESRD would be considered an ESRD in the ETC Model. We invited public attribution and our responses. Beneficiary, subject to the exclusions comment on the proposal to attribute Comment: A commenter agreed that described elsewhere in this final rule. beneficiaries on a monthly basis after using retrospective attribution is an As modified, this definition makes clear the end of the relevant MY. appropriate approach for beneficiary that beneficiaries who have already In the proposed rule, we considered attribution in a fee for service model. received a kidney transplant in the past conducting attribution prospectively, Another commenter agreed with using will be eligible for attribution to ETC before the beginning of the MY. pre-emptive transplantation for Participants once they restart dialysis or However, we concluded that beneficiary attribution. other services for ESRD. prospective attribution would not be Response: We thank the commenters We are modifying several beneficiary appropriate given the nature of ESRD for their feedback and support. CMS attribution provisions in order to and the ESRD Beneficiary population. will use retrospective beneficiary address the modification to the CKD is a progressive illness, with attribution as proposed. However, as transplant rate to include the transplant patients moving from late stage CKD to described elsewhere in this final rule, waitlist rate and the living donor ESRD—requiring dialysis or a we will use the transplant rate transplant rate, as described in section transplant—throughout the course of the calculated as the sum of the transplant IV.C.5 of this final rule. We are year. As noted in the proposed rule, we waitlist rate and the living donor finalizing the definition of ‘‘living donor therefore believe prospective attribution transplant rate, rather than the transplant (LDT) Beneficiary’’ as an would functionally exclude incident transplant rate as proposed, to assess ESRD Beneficiary who received a beneficiaries new to dialysis from ETC Participant performance under the kidney transplant from a living donor. inclusion in the home dialysis and Model. Because the living donor We are also replacing the term ‘‘Pre- transplant rates of ETC Participants transplant rate calculation will include emptive transplant beneficiary’’ with until the following MY. Additionally, only pre-emptive transplants from living the term ‘‘Pre-emptive LDT we stated our belief that prospective donors, rather than all pre-emptive Beneficiary,’’ which we define a attribution would not work well for the transplants, we will only attribute beneficiary who received a kidney particular design of this Model. In beneficiaries who received pre-emptive transplant from a living donor prior to particular, we noted in the proposed transplants from living donors prior to beginning dialysis. We are modifying rule that, because the PPA would be beginning dialysis (defined as pre- the attribution of pre-emptive transplant determined based on home dialysis and emptive living donor transplant (LDT) beneficiaries to Managing Clinicians in transplant rates during the MY, limiting beneficiaries) to Managing Clinicians. § 512.360(a), to apply solely to Pre- attribution to beneficiaries with whom After considering public comments, emptive LDT Beneficiaries and solely the ETC Participant had a care we are finalizing our proposed for purposes of assessing the Managing relationship prior to the MY would not provisions on beneficiary attribution, Clinician’s performance on the living accurately capture what occurred during with modification. Specifically, we are donor transplant rate, in accordance to the MY. As we stated in the proposed codifying in our regulations at the change from the proposed transplant rule, we believe that conducting § 512.360(a) that CMS will attribute rate to a transplant rate that includes the attribution retrospectively, after the ESRD Beneficiaries to ETC Participants living donor transplant rate described completion of the MY, would better for each month of each MY for the elsewhere in this final rule. align with the design of the PPA in the purposes of assessing an ETC ETC Model. We invited public comment Participant’s performance on the home (1) Beneficiary Exclusions on the proposal to attribute beneficiaries dialysis rate and transplant rate during We proposed to exclude certain on a monthly basis after the end of the that MY. We also are codifying in our categories of beneficiaries from relevant MY. regulations at § 512.360(a) that an ESRD attribution to ETC Participants, We proposed to provide ETC Beneficiary can be attributed to only one consistent with other CMS models and Participants lists of their attributed ESRD facility and only one Managing programs for purposes of calculating the beneficiaries after attribution has Clinician for a given month during a PPA. Specifically, we proposed to occurred, after the end of the MY. In the given MY, and that attribution takes exclude an ESRD Beneficiary or a pre- proposed rule, we considered providing place at the end of the MY. We are emptive transplant beneficiary if, at any lists in advance of the MY, or on a more codifying in our regulations at § 512.310 point during the month, the beneficiary: frequent basis. However, we determined the definition of ESRD Beneficiary as • Is not enrolled in Medicare Part B, that, since we would be conducting proposed, with modification to clarify because Medicare Part B pays for the attribution after the conclusion of the that a beneficiary who has received a majority of ESRD-related items and

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services, for which Part B claims are literature and clinical guidelines, the and Medicare Advantage plans have necessary for evaluation of the Model. commenter did not find obvious different payment structures than • Is enrolled in Medicare Advantage, exclusion criteria for home dialysis Medicare Parts A and B and do not use a cost plan, or other Medicare managed patients. Another commenter suggested FFS billing. Including these care plans, because these plans have that if a beneficiary is able to receive a beneficiaries in the Model’s financial different payment structures than transplant or dialyze at home, despite calculations could create unintended Medicare Parts A and B and do not use being on the exclusion list, CMS should consequences for ETC Participants and FFS billing. still include that beneficiary in the may complicate our evaluation of the • Does not reside in the United numerator and denominator for the ETC Model. States, because it is more difficult to Participant, in order to give the ETC Comment: Multiple commenters track and assess the care furnished to Participant credit for all transplants and recommended that CMS exclude beneficiaries who might have received home dialysis treatments. beneficiaries from attribution to ETC care outside of the U.S. Response: CMS appreciates this Participants based on factors such as • Is younger than age 18 at any point feedback regarding our proposed socioeconomic status, homelessness, in the month, because beneficiaries beneficiary exclusion criteria under the housing instability, lack of under age 18 are more likely to have Model. Like one of the commenters transportation, and lack of caregiver or ESRD from rare medical conditions that noted, the literature and clinical social support. One of those have different needs and costs guidelines do not have clear exclusions commenters listed other International associated with them than the typical for home dialysis beneficiaries. Classification of Diseases, 10th Revision ESRD Beneficiary. However, our proposed exclusions were (ICD–10) codes that address the issues • Has elected hospice, because intended to exclude from attribution to of social determinations of health hospice care generally indicates ETC Participants those categories of around housing economic insecurity, cessation of dialysis treatment and beneficiaries more likely to be specifically ICD–10 codes Z59.1, Z59.7, curative care. inappropriate candidates for home Z59.8, and Z59.9. Another commenter • Is receiving any dialysis for acute dialysis and/or transplant in order to suggested using the homelessness ICD– kidney injury (AKI) because renal track Managing Clinicians’ and ESRD 10 code Z59.0 for purposes of dialysis services for AKI differ in care facilities’ ability to provide appropriate implementing exclusions specific to and costs from a typical ESRD care to patients who can, in fact, safely homelessness, though the commenter Beneficiary who is not receiving care for have the opportunity to receive a kidney acknowledged that this code may be AKI. AKI is usually a temporary loss of transplant or home dialysis. Although underutilized. Another commenter kidney function. If the kidney injury an otherwise excluded beneficiary that suggested excluding dual eligible becomes permanent, such that the receives home dialysis, receives a LDT, beneficiaries from attribution to ETC beneficiary is undergoing maintenance or is placed on the transplant waitlist Participants as this group generally dialysis, then the beneficiary would be could be placed in the numerator and represents a population with lower eligible for attribution. the denominator, in aggregate, we socioeconomic status. • Has a diagnosis of dementia believe that these exclusions are Response: CMS agrees that housing because conducting dialysis at home appropriate for the reasons described in insecurity, transportation issues, and may present an undue challenge for the proposed rule and previously in this other social determinants of health beneficiaries with dementia, and such final rule and will apply them in affect patient choice of renal beneficiaries also may not prove to be attributing ESRD Beneficiaries to ETC replacement modality. We also appropriate candidates for transplant. Participants under the Model. appreciate the few comments In the proposed rule, we considered Comment: Commenters supported our mentioning the ICD–10 codes that could excluding beneficiaries from attribution proposal to exclude from attribution to be used to identify homelessness and for the purposes of calculating the home ETC Participants those beneficiaries other social determinants of health. dialysis rate whose advanced age (for who are not enrolled in Medicare Part However, we also agree with the example, ages 70 and older) could make B or who do not reside in the United commenter who stated that the home dialysis inappropriate; however, States. A commenter agreed with our homelessness ICD–10 code Z59.0 is we did not ascertain a consensus in the proposed exclusion for patients enrolled underutilized, and we believe that literature that supported any specific in Medicare Advantage; however, one adopting an exclusion for homelessness age cut-off. In the proposed rule, we also physician group suggested attributing based on this code could be subject to considered excluding beneficiaries with beneficiaries with Medicare Advantage gaming, such that this code would not housing insecurity from attribution for plans to ETC Participants in order to be an objective measure for housing the purposes of calculating the home appropriately assess the risk pool for the insecurity. CMS also believes that the dialysis rate, but did not find an ETC Model since ESRD Beneficiaries other codes of Z59.1, Z59.7, Z59.8, and objective way to measure housing may begin enrolling in Medicare Z59.9 could be subject to gaming. instability. Advantage plans beginning in 2021. Accordingly, we are not adopting the The following is a summary of the Response: CMS appreciates the commenters’ suggestions to use these comments received on beneficiary feedback and support. After considering codes for purposes of the Model. exclusions from attribution to ETC the public comments, we are finalizing However, CMS will assess the use of Participants and our responses. our proposal to exclude beneficiaries these and other codes for purposes of Comment: Some commenters not enrolled in Medicare Part B, adding any additional beneficiary suggested that CMS not exclude any enrolled in Medicare Advantage or other exclusions from attribution to ETC categories of beneficiaries from managed plans, and those not residing Participants based on socioeconomic attribution to ETC Participants under in the United States from attribution to status, homelessness, or other social the Model, allowing the Model to be as ETC Participants under the Model. With determinants of health through future inclusive as possible to beneficiaries, respect to the commenter’s suggestion rulemaking. despite the beneficiaries’ medical that CMS attribute Medicare Advantage Comment: Several commenters conditions or age. A commenter stated beneficiaries to ETC Participants, the appreciated our proposal to exclude that, after searching peer-reviewed ETC Model is a Medicare FFS model pediatric ESRD Beneficiaries from

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attribution to ETC Participants due to contraindications because clinical Response: CMS appreciates the the unique medical needs of this guidelines for home dialysis or suggestions from commenters regarding population. A commenter expressed transplant beneficiaries do not have clinical contradictions for home dialysis concern about of the lack of quality such exclusions. Moreover, the and kidney transplantation. CMS has measures for this small population of beneficiary attribution exclusions responded to comments and concerns patients and suggested implementing finalized in our regulations at related to risk adjustment for seriously different pediatric payment § 512.360(b) are intended to address ill populations in section IV.C.5.d reimbursements for traditional Medicare common contraindications for home (Benchmarking and scoring) and section payment for the pediatric renal dialysis and kidney transplant while IV.C.5.c.(3) (Risk Adjustment) of this beneficiaries. allowing the maximum number of final rule. CMS believes the beneficiary Response: CMS acknowledges the beneficiaries to benefit from the exclusions in proposed § 512.360(b), importance of kidney health in the opportunity to select the renal with the modifications described pediatric population, including the need replacement modality of their choice. elsewhere in this final rule, address for quality measures specific to this Comment: Several commenters common clinical contraindications for population, and believe that other HHS supported our proposal to exclude home dialysis and kidney initiatives outside of the ETC Model, beneficiaries with AKI from attribution transplantation. AKI involves short term such as Kidney X and the broader to ETC Participants. A commenter use of dialysis, making home dialysis Advancing American Kidney Health requested clarification on how an AKI impractical and transplant unnecessary, Initiative, may address this need. diagnosis in one month will affect the and as such, the AKI exclusion exists Comments related to provider application of this exclusion for because the Model tests incentives reimbursement in the Medicare program subsequent months for attribution to specific to chronic dialysis services. generally are outside the scope of this ETC Participants. Beneficiaries diagnosed with dementia final rule. Response: We thank the commenters or who reside in or receive dialysis in Comment: Several commenters for their feedback and support and a skilled nursing facility (SNF) or supported excluding beneficiaries from clarify that receipt of dialysis services nursing facility may not be suitable attribution to ETC Participants due to for an AKI diagnosis in one month candidates for both home dialysis or old age. These commenters suggested makes a beneficiary ineligible for transplantation. The exclusions still excluding beneficiaries over the ages of attribution to an ETC Participant for that provide suitable incentives for ETC 65, 70, or 75 from the calculation of month, but if the AKI does not resolve Participants to support the greatest either the transplant rate, home dialysis and/or transitions to ESRD, the number of ESRD Beneficiaries in rate, or both, since these patients often beneficiary will become eligible for receiving home dialysis or being added do not receive a kidney transplant or attribution in a subsequent month. CMS to the kidney transplant waitlist with have limited access to the caregiver acknowledges that patient health status the ultimate goal of receiving a kidney support required for home dialysis. A may change over time. transplant. We also note that many of few commenters recommended that Comment: Many commenters the clinical contraindications suggested CMS not exclude beneficiaries from identified possible additional by commenters for home dialysis are in attribution to ETC Participants due to beneficiary exclusions due to clinical fact potential contraindications for PD, age, particularly due to the aging contradictions that prevent patients and are not contraindications for HHD. population, and instead stressed the from meeting the clinical criteria for Adding a large number of beneficiary importance of other factors to determine home dialysis or transplant. Examples exclusion criteria would run counter to a beneficiary’s exclusion under the included: Severe diabetic neuropathy or the Model’s focus on increasing the Model, such as functional status and congestive heart failure, recent vascular clinical contradictions for home dialysis disease, significant physical disability utilization of home dialysis and and kidney transplantation in order to (Karnofsky Score <40 percent), transplants for ESRD Beneficiaries, and align with a beneficiary’s treatment cardiomyopathy with EF<20 percent, adopting exclusions based on choice and suitable care. severe pulmonary or cardiovascular documentation of clinical condition Response: CMS appreciates the issues, cirrhosis, documented recent could be subject to gaming. comments on possible beneficiary cardiac surgery, severe morbid obesity Comment: Multiple commenters exclusions due to age but notes that (BMI>50), documented status that a recommended that CMS exclude from there is no objective scientific evidence patient is unsuitable for a transplant or attribution to ETC Participants those to tie old age to incompatibility with home dialysis, active infection, beneficiaries with cancer, including home dialysis. Moreover, we believe an medication non-compliance, those diagnosed with recent solid organ age restriction would undermine the uncontrolled psychiatric illness or malignancy and patients currently Model’s focus on providing substance abuse, or blindness. Several receiving related treatment, as cancer is beneficiaries the opportunity to select commenters also recommended certain a contraindication for transplantation home dialysis. Therefore, CMS will not exclusion criteria specific to home candidacy and may result in variable restrict beneficiary attribution due to dialysis, including: Recent abdominal dialysis use, in which a beneficiary’s age. However, as described in section surgery, abdominal abscess, peritoneal ESRD treatment modality may change § 512.365(c) of this final rule, we are scarring or failed PD attempts, blindness frequently based on adjustments in finalizing our proposal to exclude or impaired vision, irritable bowel cancer treatment such as chemotherapy beneficiaries over the age of 75 from the syndrome, and diabetic gastroparesis. If timing and dosage. Some commenters numerator and the denominator of the these beneficiaries are not excluded stated that home dialysis may be transplant rate calculation since these from attribution, commenters urged inappropriate for beneficiaries with patients usually are not candidates for CMS to include these more seriously ill cancer due to complex needs, need for transplants. populations in the risk adjustment and a caregiver, and challenging care Additionally, we decline to adopt the PPA in order appropriately compare coordination and thus these patients commenters’ recommendations that group benchmarks, align beneficiaries, often prefer receiving dialysis in the CMS establish exclusions based on and provide the ideal care in the ideal same setting, suggesting that these functional status and clinical setting for these beneficiaries. patients may prefer in-center dialysis.

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Response: CMS appreciates the back to in-center dialysis. A few palliative care in a beneficiary’s final suggestion to exclude beneficiaries with commenters suggested altering the phase of life rather than dialysis a diagnosis of cancer and acknowledges exclusion for beneficiaries by including services. We agree with the commenters commenters’ concerns of treatment beneficiaries diagnosed with dementia who suggested excluding beneficiaries appropriateness. While CMS who reside in a SNF or are treated for who elect hospice since hospice care is understands the burden of cancer for AKI at a SNF, as SNFs provide a safer by definition time limited and indicates both caregivers and beneficiaries, this alternative than home dialysis for such that the beneficiary is close to the end exclusion would not advance the Model beneficiaries needing dialysis. of life. test because it would not result in the Response: CMS appreciates the Comment: A few commenters greatest number of ESRD Beneficiaries feedback recommending that CMS suggested excluding beneficiaries who in receiving home dialysis or being exclude from attribution to ETC choose palliative care for their renal added to the kidney transplant waitlist Participants those beneficiaries residing care modality. One of these commenters with the ultimate aim of receiving a in SNFs and nursing facilities. We share suggested tracking these more seriously kidney transplant. Moreover, there are the commenters’ concerns about dialysis ill beneficiaries differently from the no clear exclusion criteria for home provided in SNFs, particularly around healthier ESRD population and dialysis for beneficiaries with any the misalignment of dialysis utilization rewarding medical management for cancer diagnosis, and it is CMS’s belief in SNFs and nursing facilities with the these patients receiving any type of that these beneficiaries often are not Model’s focus on promoting beneficiary ESRD care, including those not utilizing automatically ineligible for choice of treatment modality. In dialysis and instead receiving palliative transplantation. CMS would like to addition, CMS is concerned that the or hospice care. encourage ETC Participants to provide population of beneficiaries who reside Response: CMS appreciates the home dialysis and transplantation for as in SNFs and nursing facilities is feedback to exclude beneficiaries many beneficiaries that would benefit particularly frail, including beneficiaries choosing supportive care. CMS will from these care modalities. diagnosed with dementia, and therefore exclude beneficiaries who have elected Comment: Multiple commenters may not be appropriate candidates for hospice; however, we believe rewarding supported our proposed exclusion of home dialysis. Accordingly, we believe medical management of hospice beneficiaries with a diagnosis of that attributing these ESRD Beneficiaries beneficiaries is outside the scope of the dementia. Some of these commenters to ETC Participants would not advance Model and addressed in other HHS and who supported excluding beneficiaries the Model goals of improving or CMS initiatives, such as the Medicare with a diagnosis of dementia suggested maintaining quality while reducing cost Care Choices Model. modifying our proposal to nonetheless by increasing home dialysis rates and Comment: A commenter agreed with include beneficiaries with a diagnosis of transplant rates with the ultimate aim of our proposals to attribute beneficiaries mild dementia to allow health receiving a kidney transplant. As such, to ETC Participants on a monthly basis professionals to determine the CMS will exclude all beneficiaries and not exclude beneficiaries with appropriateness of home dialysis for the residing in or receiving dialysis in a Medicare as a secondary payer from patient, especially for patients with SNF or nursing facility from attribution attribution. However, the commenter access to assisted home dialysis to ETC Participants under the Model. suggested that we provide beneficiary programs. We also recognize that some attribution data to ETC Participants on Response: CMS appreciates the beneficiaries may benefit from the level a more frequent basis. commenters’ suggestion that CMS of care in a SNF or nursing facility, such Response: CMS appreciates the attribute beneficiaries with a diagnosis as beneficiaries with dementia. feedback and support. Beneficiary of mild dementia to ETC Participants in Dementia beneficiaries are excluded attribution will occur on a monthly order to preserve clinical judgement. from the attribution to ETC Participants. basis. However, attribution will occur While CMS understands that Including beneficiaries residing in SNFs after the MY is over. Thus, while CMS beneficiaries with mild dementia may and nursing facilities does not align will endeavor to provide attribution be covered by the exclusion criteria, and with the Model’s goals of increase home data to ETC Participants on a timely thus be excluded from attribution to dialysis in a beneficiaries’ home. basis, these data will be provided only ETC Participants, we clarify that in Comment: A few commenters after the MY is over. CMS believes order to objectively identify patients supported our proposed exclusion of providing accurate beneficiary with dementia, as described in greater beneficiaries who have elected hospice attribution data is vital to ETC detail later in this final rule, we will use from attribution to ETC Participants participants. Because the MYs overlap, the most current Hierarchical Condition since hospice care generally indicates beneficiary attribution data for one MY Category (HCC) model codes that assess cessation of dialysis treatment and will be available during the fourth dementia, and note that there is no dialysis care. A couple of commenters quarter of the following MY, which will objective way to track dementia recommended not excluding provide the most accurate information progression or deterioration. HCC beneficiaries who have elected hospice within a reasonable amount of time. dementia codes that specify ‘‘without for purposes of calculating the home After considering public comments, behavioral disturbance’’ cannot dialysis rate specifically, since PD is we are finalizing our proposed objectively track progression of less costly than in-center HD and offers provisions regarding the exclusion of dementia. patients treatment options. certain categories of beneficiaries from Comment: Multiple commenters Response: We appreciate the feedback attribution to ETC Participants with recommended that CMS exclude from from commenters. While we appreciate modification. CMS will use the claim attribution to ETC Participants those the commenters’ recommendation to service date for purposes of the general beneficiaries who reside in group homes include beneficiaries who have elected attribution criteria described in or nursing homes, pointing out that hospice in the Model’s attribution § 512.360. However, Managing SNFs construct an in-center dialysis methodology, we do not believe that Clinicians and ESRD Facilities utilize facility inside the nursing facility and doing so would offer more treatment different billing requirements and that once beneficiaries are discharged choices to beneficiaries because in forms. For consistency with these from the SNF, they most often transition general, hospice care focuses on billing requirements and forms, CMS

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will use the claim service date at the described, will be excluded from relationship with the ESRD Beneficiary claim line through date to attribute attribution to ETC Participants for a in question for the given month. For beneficiaries to Managing Clinicians month for the purposes of calculating example, using the earliest claim and will use the claim service date at the transplant rate and home dialysis approach could result in attributing a the claim header through date to rate under the Model. In addition, based beneficiary that received dialysis attribute beneficiaries to ESRD on public comments, we are also treatments from Facility A once during Facilities. excluding beneficiaries from attribution a given month and dialysis treatments In addition, in this final rule, we are for any month in which they receive from Facility B at all other times during modifying our proposed exclusions dialysis in or reside in a SNF or nursing that month to Facility A, even though from attribution for ESRD Beneficiaries facility. Facility B is the facility where the with a diagnosis of dementia to clarify beneficiary received most of his or her (2) Attribution Services that such diagnosis must be made at any dialysis treatments that month. As noted point during the month or the preceding (a) Attribution to ESRD Facilities in the proposed rule, we would, 12 months, as identified using the most We proposed that, to be attributed to however, plan to use the earliest date of recent dementia criteria at the time of an ESRD facility for a month, an ESRD service in the event that two or more beneficiary attribution, defined using Beneficiary must have received renal ESRD facilities have furnished the same the dementia-related codes from the dialysis services, other than renal amount of services to a beneficiary Hierarchical Condition Category (HCC) dialysis services for AKI, during the because, as between two or more Risk Adjustment Model ICD–10–CM month from the ESRD facility. Because facilities that performed the same Mappings. We will use the HCC Risk it is possible that a single ESRD number of dialysis treatments for the Adjustment Model because it includes Beneficiary receives dialysis treatment beneficiary during a month, the facility all objectively related dementia from more than one ESRD facility that furnished services to the diagnosis codes. A 13-month lookback beneficiary first may have established period, which includes the entire month during a month, we further proposed that ESRD Beneficiaries would be the beneficiary’s care plan and therefore in question plus the preceding 12 is the one more likely to have the most months lookback period for the attributed to an ESRD facility for a given month based on the ESRD facility at significant treatment relationship with dementia exclusion aligns with the the beneficiary. periodicity with which the HCC Risk which the ESRD Beneficiary received the plurality of his or her dialysis In the proposed rule we also Adjustment Model codes are updated, considered using a minimum number of and will ensure that CMS has sufficient treatments in that month. As we noted in the proposed rule, we believe the treatments at an ESRD facility for data to identify a dementia diagnosis, purposes of ESRD Beneficiary while also ensuring that any such plurality rule would provide a sufficient standard for attribution because it attribution. However, we determined diagnoses are still relevant and current that, because we are attributing ESRD for the beneficiary. For reference, the ensures that ESRD Beneficiaries would Beneficiaries on a month-by-month 2020 Midyear Final ICD–10–CM be attributed to an ESRD facility when basis, the plurality of treatments method Mappings are found at https:// they receive more renal dialysis services would be more appropriate because it www.cms.gov/Medicare/Health-Plans/ from that ESRD facility than from any would result in a greater number of MedicareAdvtgSpecRateStats/Risk- other ESRD facility. In the event that an ESRD Beneficiaries attributed to the Adjustors-Items/Risk2020. ESRD Beneficiary receives an equal In addition, we are modifying our number of dialysis treatments from two ESRD facilities where they receive care, exclusion for beneficiaries younger than or more ESRD facilities in a given which may enhance the viability of the 18 years of age to state that a beneficiary month, we proposed that the ESRD ETC Model test. In the proposed rule we will be excluded from attribution to an Beneficiary would be attributed to the also considered including a minimum ETC Participant if he or she is younger ESRD facility at which the beneficiary duration that an ESRD Beneficiary must than 18 years old before the first day of received the earliest dialysis treatment be on dialysis before the beneficiary can the month of the claim service date. We that month. be attributed to an ESRD facility. We will identify the beneficiary’s age on the We proposed that we would identify determined that this approach was not first day of the month (rather than for dialysis claims as those with Type of suitable for this model test, however, as the entire month), as it is easier for CMS Bill 072X, where the type of facility a key factor that influences whether or to operationalize and has the same code is 7 and the type of care code is not a beneficiary chooses to dialyze at practical effect (that is, a beneficiary 2, and that have a claim through date home is if the beneficiary begins who is at least 18 years old before the during the month for which attribution dialysis at home, rather than in-center. first date of a month will be at least 18 is being determined. Type of Bill 072X Requiring a minimum duration on years old for that entire month). In captures all renal dialysis services dialysis would exclude these early addition, because we will be assessing furnished at or through ESRD facilities. months of dialysis treatment from ETC Participant performance on the Facility code 7 paired with type of care attribution, which may be key to a transplant rate calculated as the sum of code 2 indicates that the claim occurred beneficiary’s modality choice, and the transplant waitlist rate and the at a clinic or hospital based ESRD would therefore run counter to the living donor transplant rate in response facility. intent of the ETC Model. to public comments, we have removed In the proposed rule we considered, We proposed that CMS would not references to pre-emptive transplant in the alternative, attributing ESRD attribute pre-emptive transplant beneficiaries from our regulation at Beneficiaries to the ESRD facility at beneficiaries to ESRD facilities because § 512.360(b), and replaced them with which they had their first dialysis beneficiaries who receive pre-emptive references to Pre-emptive LDT treatment for which a claim was transplants do so before they have Beneficiaries, where appropriate. submitted in a given month. However, initiated dialysis and thus do not have In sum, we are codifying in our we determined that using the plurality a care relationship with the ESRD regulation at § 512.360(b) that ESRD of claims rather than earliest claim facility. Beneficiaries that fall in the enumerated better identifies the ESRD facility that The following is a summary of the categories, with the modifications has the most substantial care comments received on ESRD

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Beneficiary attribution to ESRD facilities be attributed to the ESRD facility at attribute pre-emptive transplant and our responses. which the beneficiary received the beneficiaries to Managing Clinicians. Comment: A commenter earliest dialysis treatment that month, as Because pre-emptive transplant recommended that CMS exclude from proposed. We clarify that this policy for beneficiaries have not started dialysis at attribution to an ESRD facility those attributing ESRD Beneficiaries who have the time of their transplant, we ESRD Beneficiaries who have three or received an equal number of dialysis explained we would not be able to more dialysis treatments in another treatments from two or more ESRD attribute them to Managing Clinicians ESRD facility for that month. The facilities would apply regardless of based on MCP claims, as we would for commenter instead suggested that CMS whether the ESRD facility is an ETC ESRD Beneficiaries. Rather, we attribute an ESRD Beneficiary to the Participant or an ESRD facility located proposed that pre-emptive transplant ESRD facility at which the ESRD in a Comparison Geographic Area. As beneficiaries would be attributed to a Beneficiary received the most described elsewhere in this final rule, Managing Clinician based on the treatments, which the commenter we have modified our proposal to Managing Clinician with whom the referenced as the ESRD Beneficiary’s attribute pre-emptive transplant beneficiary had the most services ‘‘home facility.’’ beneficiaries to Managing Clinicians between the start of the MY and the Response: As noted in the proposed such that we will attribute only pre- month in which the beneficiary received rule, we believe that the plurality of emptive LDT beneficiaries. We therefore the transplant, and that the pre-emptive dialysis treatments approach for modified our regulation at transplant beneficiary would be attributing ESRD Beneficiaries to ESRD § 512.360(c)(1) to clarify that CMS does attributed to the Managing Clinician for facilities provides a sufficient standard not attribute pre-emptive LDT all months between the start of the MY for attribution because it ensures that beneficiaries to ESRD facilities. and the month in which the beneficiary ESRD Beneficiaries will be attributed to received the transplant. In the proposed an ESRD facility that has the primary (b) Attribution to Managing Clinicians rule we considered attributing pre- responsibility for the beneficiary’s renal We proposed that, for Managing emptive transplant beneficiaries on a dialysis services. Clinicians, an ESRD Beneficiary would month-by-month basis, mirroring the After considering public comments, be attributed to the Managing Clinician month-by-month attribution of ESRD we are finalizing our proposed who submitted an MCP claim with a Beneficiaries. However, we concluded provisions on the services used to claim through date in a given month for that this approach would under- attribute ESRD Beneficiaries to ESRD certain services furnished to the ESRD attribute beneficiary months to the facilities with modification. Beneficiary. Per the conditions for denominator. Unlike ESRD Beneficiaries Specifically, we are codifying in our billing the MCP, the MCP can only be who see their Managing Clinician every regulations at § 512.360(c)(1) that ESRD billed once per month for a given month for dialysis management, pre- Beneficiaries will be attributed to an beneficiary.151 Therefore, as noted in emptive transplant beneficiaries ESRD facility for a given month based the proposed rule, we believe there is no generally do not see a Managing on the ESRD facility at which the ESRD need to create a decision rule for Clinician every month because they Beneficiary received the plurality of his attributing ESRD Beneficiaries to a have not started dialysis. However, that or her dialysis services in that month, Managing Clinician for a given month if does not mean that an ongoing care other than renal dialysis services for there are multiple MCP claims that relationship does not exist between the AKI, based on claims with claim service month, as that should never happen. We pre-emptive transplant beneficiary and date at the claim header date during that proposed that, for purposes of ESRD the Managing Clinician in a month with month with Type of Bill 072X. We are Beneficiary attribution to Managing no claim. modifying the regulation text to clarify Clinicians, we would include MCP The following is a summary of the that an ESRD Beneficiary would not be claims with CPT® codes 90957, 90958, comments received on beneficiary attributed to an ESRD facility if the 90959, 90960, 90961, 90962, 90965, or attribution to Managing Clinicians and beneficiary is excluded from attribution 90966. CPT® codes 90957, 90958, our responses. based on the criteria specified in our 90959, 90960, 90961, and 90962 are for Comment: A commenter stated that regulations at § 512.360(b), described ESRD-related services furnished some complex patients have two elsewhere in this final rule. We are monthly, and indicate beneficiary age nephrologists managing their care and modifying which date associated with (12–19, or 20 years of age and older) and suggested that both of these Managing the claim we are using to determine if the number of face-to-face visits with a Clinicians should receive attribution in the claim occurred during the physician or other qualified health care these scenarios. Another commenter applicable PPA Period. Whereas we professional per month (1, 2–3, 4 or suggested that pre-emptive transplant proposed using the claim through date, more). CPT® codes 90965 and 90966 are beneficiaries be attributed to the we are finalizing using the date of for ESRD-related services for home Managing Clinician who initiated the service on the claim, to align with dialysis per full month, and indicate the referral to the transplant center to allow Medicare claims processing standards. age of the beneficiary (12–19, or 20 ‘‘proactive management.’’ Other We are making this change because years of age and older). We explained in commenters stressed the importance of while Medicare claims data contains the proposed rule that, taken together, educating beneficiaries on renal both claim through dates and dates of ® replacement modality options and the these are all the CPT codes that are service, Medicare claims are processed shared decision-making process in order used to bill the MCP that include based on dates of service, requiring us to empower beneficiaries to select from beneficiaries 18 years old or older, to use claim date of service to identify among the available treatment choices including patients who dialyze at home the PPA Period in which the service was and suggested that CMS attribute and patients who dialyze in-center. furnished. We are also codifying in our Additionally, for the transplant rate beneficiaries to ESRD facilities and regulation at § 512.360(c)(1) that, in the for Managing Clinicians, we proposed to Managing Clinicians that, through event that an ESRD Beneficiary receives extensive education, time, and effort, an equal number of dialysis treatments 151 Medicare Claims Processing Manual, Chapter refer ESRD Beneficiaries to facilities that from two or more ESRD facilities in a 8; https://www.cms.gov/Regulations-and-Guidance/ offer home dialysis. Many of these same given month, the ESRD Beneficiary will Manuals/Downloads/clm104.c08.pdf. commenters suggested attribution based

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on the Managing Clinician who 90959, 90960, 90961, 90962, 90965, or with the latest claim service date at the educated the beneficiary on treatment 90966. We stated in the proposed rule claim line through date for the modality instead of the Managing that there is no need to create a decision beneficiary, up to and including the Clinician providing a certain dialysis- rule for attributing ESRD Beneficiaries month of the transplant. If more than related service. to a Managing Clinician for a given one of these Managing Clinicians has Response: CMS appreciates the month because the full month MCP the latest claim service date at the claim feedback from the commenters about CPT® codes can only be billed once per line through date for that beneficiary, beneficiary attribution to Managing month for a given beneficiary. However, the Pre-emptive LDT Beneficiary will be Clinicians. While CMS acknowledges we found a very small number of randomly attributed to one of those that two or more Managing Clinicians instances where the full month MCP Managing Clinicians. may manage care for a given ESRD code was billed by multiple Managing In addition, we are modifying which Beneficiary, for the purposes of this Clinicians for a given beneficiary. To date associated with the claim we are Model, we believe that attribution to address the rare case that an MCP is using to determine if the claim occurred one Managing Clinician is most billed in a single month by more than during the applicable PPA Period. appropriate because generally only one one Managing Clinician, we also added Whereas we proposed using the claim MCP is billed for a given ESRD new text to our regulation at through date, we are finalizing using the Beneficiary during a month, even if § 512.360(c)(2) to clarify that, in cases date of service on the claim, to align multiple Managing Clinicians are where more than one Managing with Medicare claims processing involved in beneficiary’s care. In Clinician submits a claim for the MCP standards. We are making this change addition, if the ESRD Beneficiary furnished to a single ESRD Beneficiary because while Medicare claims data receives care from one or more other with a claim service date at the claim contains both claim through dates and clinicians within the practice of the line through date in a month, the ESRD dates of service, Medicare claims are Managing Clinician to whom the ESRD Beneficiary will be attributed to the processed based on dates of service, Beneficiary is attributed, the care Managing Clinician associated with the requiring us to use claim date of service furnished to that ESRD Beneficiary will earliest claim service date at the claim to identify the PPA Period in which the be considered in assessing the line through date that month. In cases service occurred. We have revised performance for all such clinicians where more than one Managing § 512.360(c)(2) of this final rule under the aggregation methodology Clinician submits a claim for the MCP accordingly. described elsewhere in section IV of this furnished to a single ESRD Beneficiary c. Performance Measurement final rule. Additionally, while we for the same earliest claim service date appreciate feedback about the We proposed to calculate the home at the claim line through date for that dialysis and transplant rates for ESRD attribution of pre-emptive transplant month, the ESRD Beneficiary will be beneficiaries, we do not believe that facilities and Managing Clinicians using randomly attributed to one of these Medicare claims data and Medicare attributing pre-emptive transplant Managing Clinicians. beneficiaries to the Managing Clinician administrative data about beneficiaries, who refers them to the transplant center In addition, we are modifying our providers, and suppliers. We noted in is appropriate for the Model. As proposed method for attributing pre- the proposed rule that Medicare described elsewhere in this final rule, emptive transplant beneficiaries to administrative data refers to non-claims we are now only attributing Pre-emptive Managing Clinicians. As described in data that Medicare uses as part of LDT Beneficiaries to Managing section IV.C.5 of this final rule, the regular operations. This includes Clinicians given the change to the transplant rate calculation will include information about beneficiaries, such as calculation of the transplant rate. only living donor transplants, rather enrollment information, eligibility Attributing these Pre-emptive LDT than all kidney transplants including information, and demographic Beneficiaries to Managing Clinicians those received from deceased donors. information. Medicare administrative based on who refers a Pre-emptive LDT As such, we are modifying pre-emptive data also refers to information about Beneficiary to a transplant center may transplant beneficiary attribution to Medicare-enrolled providers and not identify the Managing Clinician Managing Clinicians in § 512.360(c)(2) suppliers, including Medicare primarily responsible for supporting the of our regulation to include only Pre- enrollment and eligibility information, beneficiary through the living donor emptive LDT Beneficiaries, rather than practice and facility information, and transplant process. Rather, we believe all beneficiaries who receive a kidney Medicare billing information. For the that the main care relationship between transplant prior to beginning dialysis, transplant rate calculations, we also Pre-emptive LDT Beneficiary and including from deceased donors. proposed to use data from the Scientific Managing Clinician is more accurately Consistent with our approach for Registry of Transplant Recipients identified using the methodology attributing pre-emptive transplant (SRTR), which contains comprehensive included in this final rule. beneficiaries to Managing Clinicians, we information about transplants that occur After considering public comments, are finalizing that a Pre-emptive LDT in the U.S., to identify transplants we are finalizing our proposed Beneficiary will be attributed to the among attributed beneficiaries for provisions on the services used to Managing Clinician with whom the inclusion in the numerator about the attribute beneficiaries to Managing beneficiary had the most claims occurrence of kidney and kidney- Clinicians, with modification. We are between the start of the MY and the pancreas transplants. In the proposed finalizing in our regulation at month of the transplant. We are also rule, we considered requiring ETC § 512.360(c)(2) that we will attribute finalizing that, in the event that no Participants to report on their home ESRD Beneficiaries to the Managing Managing Clinician had the plurality of dialysis and transplant rates, as this Clinician who bills an MCP for services claims for a given Pre-emptive LDT would give ETC Participants more furnished to the beneficiary claim Beneficiary, such that multiple transparency into their rates. However, service date at the claim line through Managing Clinicians each had the same as noted in the proposed rule, we date during the entire month in number of claims for that beneficiary believe basing the rates on claims data, question, and that such claims will be during the MY, that beneficiary will be supplemented with Medicare identified by CPT® codes 90957, 90958, attributed to the Managing Clinician administrative data about beneficiary

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enrollment and transplant registry data Comment: Multiple commenters exclusion only to the denominator of about transplant occurrences, will stated that it is important to protect the home dialysis rate such that such ensure there is no new reporting burden patient choice of treatment modality, beneficiaries would be included in the on ETC Participants. Additionally, using which may depend on the beneficiary’s numerator if they received home these existing data sources would be financial resources, housing, social dialysis. A commenter recommended more cost effective for CMS, as it would support, and personal preference even classifying SNFs, inpatient not require the construction and after proper education on all possible rehabilitation facilities, and long-term maintenance of a new reporting portal, ESRD treatment choices. These care hospitals (LTCH) as a home dialysis or changes to an existing reporting commenters recommended that CMS site for patients that receive on-site portal to support this data collection. consider revising the home dialysis rate dialysis at one of the respective We solicited comment on our to include shared-decision making locations. proposed use of claims data, Medicare measures that take into account the Multiple commenters supported the beneficiary enrollment data, and treatment modality most clinically and inclusion of beneficiaries who dialyze at transplant registry data to calculate the socially appropriate for the beneficiary. SNFs in the calculation of the home home dialysis rate and transplant rate. Response: We agree with commenters dialysis rate, with some commenters The following is a summary of the that it is important to protect patient pointing out that ESRD facilities may comments received and our responses. choice of treatment modality, but provide dialysis services to SNF Comment: A commenter supported disagree that a shared decision measure residents within an approved home our proposal to use Medicare claims should be included in the home dialysis training and support modality in cases data and Medicare administrative data rate calculation due to possible gaming where beneficiaries, such as those with for purposes of calculating the home and lack of shared decision making AKI or dementia, may have better dialysis rate and the transplant rate, and measures specific to home dialysis. quality of life when receiving dialysis in Comment: A few commenters our proposal to use data from the SRTR a SNF. suggested including ESRD Beneficiaries Response: We appreciate these for purposes of calculating the enrolled in Medicare Advantage plans comments, and share the commenters’ transplant rate. in the numerator of the home dialysis concerns about including beneficiaries Response: We appreciate the feedback rate calculation, with one of those residing in or receiving dialysis in a and support from the commenter. As commenters explaining that these SNF or nursing facility in the home described in the proposed rule, we beneficiaries often utilize in-center self- dialysis rate calculations. We disagree proposed to use these existing data care dialysis. According to the with commenters that support including sources to avoid imposing an commenters, adding these beneficiaries, these beneficiaries in the home dialysis administrative burden on ETC presumably to the numerator of the rate. As described previously in section Participants. home dialysis rate calculation, could IV.B.1 of this final rule, in our After considering public comments, mitigate risks that Managing Clinicians regulations at § 512.360(b), we are we are finalizing our proposed have for these more serious, medically excluding beneficiaries who are residing provisions on the sources of data used complex beneficiaries for whom in- in or receiving dialysis services in SNFs for measuring the performance of ETC center self-care dialysis is a safer option and nursing facilities from attribution to Participants under the Model with than home dialysis. ETC Participations for purposes of the modification. Specifically, as the Response: Consistent with the PPA calculation generally for the transplant rate calculation will include beneficiary exclusions from attribution reasons described in section IV.B.1. only living donor transplants, rather codified in our regulations at After considering public comments, than all kidney transplants including § 512.360(b), we will not include ESRD we are finalizing our general proposal those received from deceased donors, Beneficiaries enrolled in Medicare regarding the home dialysis rate as we are modifying our regulation at Advantage in the calculation of the proposed. We are also finalizing the § 512.365(a) to refer to Pre-emptive LDT home dialysis rate because the ETC definition of the home dialysis rate as Beneficiaries rather than pre-emptive Model is not a test of the Medicare proposed without modification in our transplant beneficiaries. Advantage program or payment. regulation at § 512.310. Specific (1) Home Dialysis Rate Specifically, the ETC Model is designed provisions regarding the home dialysis as a test within Medicare FFS, which rate calculation for ESRD facilities and We proposed to define ‘‘home dialysis excludes Medicare Advantage enrollees Managing Clinicians are detailed in the rate’’ as the rate of ESRD Beneficiaries from attribution to ETC Participants for following sections of this final rule. attributed to the ETC Participant who purposes of the Model’s financial dialyzed at home during the relevant calculations, including the PPA. As (a) Home Dialysis Rate for ESRD MY, as described in § 512.365(b) (Home such, it would be inappropriate to Facilities Dialysis Rate). We proposed to construct include beneficiaries enrolled in We proposed that the denominator of the home dialysis rate for ETC Medicare Advantage in the construction the home dialysis rate for ESRD Participants that are ESRD facilities as of the home dialysis rate. facilities would be the total dialysis described in the proposed rule and Comment: Several commenters treatment beneficiary years for section IV.C.5.c.1.a of this final rule and recommended that we exclude attributed ESRD Beneficiaries during the for ETC Participants who are Managing beneficiaries residing in or receiving MY. Dialysis treatment beneficiary years Clinicians as described in the proposed dialysis in a SNF or nursing facility included in the denominator would be rule and section IV.C.5.c.1.b of this final from our calculation of the home composed of those months during rule. We described in the proposed rule dialysis rate. Some commenters clarified which attributed ESRD Beneficiaries and describe later in this final rule our that beneficiaries often reside in a received maintenance dialysis at home proposed plan for risk adjusting and nursing facility or utilize a SNF as a or in an ESRD facility, such that one reliability adjusting these rates. more permanent residence, and as such, beneficiary year is comprised of 12 The following is a summary of the the dialysis received in a SNF more beneficiary months. We would identify comments received on the home resembles in-center dialysis. A months during which an attributed dialysis rate and our responses. commenter suggested that we apply the ESRD Beneficiary received maintenance

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dialysis based on claims, specifically The following is a summary of the already defined condition code under claims with Type of Bill 072X, where comments received on the home the ESRD PPS for self-dialysis. the type of facility code is 7 and the dialysis rate calculation for ESRD Therefore, we are finalizing the home type of care code is 2. Facility code 7 facilities and our responses. dialysis rate numerator for ESRD paired with type of care code 2, Comment: Some commenters agreed facilities to include self-dialysis, as indicates that the claim occurred at a with the primary construction of the identified by condition code 72, at one clinic or hospital based ESRD facility, home dialysis rate, as proposed. Other half of the value of home dialysis. We and the Type of Bill 072X captures all commenters argued that condition codes believe this policy will effectively renal dialysis services furnished at or of 74, 75, 76, and 80 provide little balance the benefits of self-dialysis and through ESRD facilities. predictive value. Many commenters its ability to help beneficiaries transition We proposed that the numerator of stated that self-dialysis should be to home dialysis with the recognition the home dialysis rate for ESRD included in the home dialysis rate that self-dialysis is not home dialysis facilities would be the total number of numerator, particularly for patients who and does not have all of the same dialysis treatment beneficiary years may be more seriously ill and for whom benefits. Specifically, each beneficiary during the MY in which attributed self-care in-center dialysis is a better month for which an attributed ESRD Beneficiaries received treatment modality. CMS received a beneficiary receives self-dialysis will maintenance dialysis at home. Home letter from a coalition of 26 stakeholders contribute one half month to the dialysis treatment beneficiary years including nephrologists, ESRD facilities, numerator. included in the numerator would be patients, and manufacturers, which Comment: Several commenters composed of those months during recommended that self-dialysis should suggested including beneficiaries who which attributed ESRD Beneficiaries be included in the numerator for home have received home dialysis training, as received maintenance dialysis at home, dialysis rate calculation for ESRD identified by claims with condition such that one beneficiary year is facilities. The coalition’s letter also code 73, in the numerator of the home comprised of 12 beneficiary months. We urged that the definition of self-dialysis dialysis rate calculation for ESRD would identify maintenance dialysis at be further clarified beyond what is facilities. Other commenters suggested home months based on claims, already present in 42 CFR 494.10 and that CMS include in the numerator specifically claims with Type of Bill recommended that CMS identify self- beneficiaries who have received re- 072X, where the type of facility code is dialysis using condition code 72, since training treatment (as identified by 7 and the type of care code is 2, with self-care in-center dialysis is tracked conditions code 87 and full care in unit condition codes 74, 75, 76, or 80. through this code. Other commenters (as identified by condition code 71), Facility code 7 paired with type of care similarly suggested a broader definition when used in combination with the code 2, indicates that the claim occurred for self-care dialysis or suggested that Revenue Code 0831 (urgent start PD) to at a clinic or hospital based ESRD CMS use the commenters’ ESRD encourage transitions to home dialysis facility. Type of Bill 072X captures all facilities’ criteria for establishing a as well as to capture patients who renal dialysis services furnished at or patient as ‘‘self-care’’, such as a patient require abdominal surgery and hope to through ESRD facilities. We stated in setting up the machine without transition back to home dialysis. A the proposed rule that condition codes assistance or pulling the needle at the commenter suggested that we allow at 74 and 75 indicate billing for a patient end of treatment. A commenter least 90 days to classify patients under who received dialysis services at home, suggested treating homeless these PD condition codes before and condition code 80 indicates billing beneficiaries receiving self-dialysis in- including these beneficiaries in the for a patient who received dialysis center as a home dialysis patient for numerator of the home dialysis rate services at home and the patient’s home purposes of calculating the home calculation to take into account delays is a nursing facility. Condition code 76 dialysis rate, since these patients do not of PD use for various health reasons that indicates billing for a patient who have the option of dialyzing at home. would not negatively affect ETC dialyzes at home but received back-up Response: CMS appreciates the Participants. dialysis in a facility. As noted in the commenters’ suggestions for identifying Response: We appreciate the feedback proposed rule, taken together, we self-care in-center dialysis patients. We from the commenters, and recognize the believe these condition codes capture agree with commenter feedback that importance of home dialysis training, as home dialysis services furnished by self-dialysis can be identified with well as retraining and full care in unit. ESRD facilities. Information used to condition code 72. We also appreciate We believe that including beneficiaries calculate the ESRD facility home that self-dialysis may serve as a way to who have received these services in the dialysis rate includes Medicare claims provide a gradual transition from in- numerator of the home dialysis rate for data and Medicare administrative data. center dialysis to home dialysis, ESRD facilities is not necessary to create In the proposed rule, we considered allowing patients to become comfortable the financial incentives we seek to test including beneficiaries whose dialysis with conducting dialysis under medical under the proposed ETC Model and that modality is self-dialysis or temporary supervision. We considered including training incentives are captured through PD furnished in the ESRD facility at a beneficiaries whose treatment modality training add-on payment adjustment for transitional care unit in the numerator, is self-dialysis in the numerator of the home dialysis under the ESRD PPS. given that these modalities align with home dialysis rate in the proposed rule, After considering public comments, one of the overarching goals of the pointing out that it was consistent with we are finalizing our proposed proposed ETC Model, to increase the overarching goals of the ETC Model provisions on the calculation of the beneficiary choice regarding ESRD and helped to promote beneficiary home dialysis rate for ESRD facilities, treatment modality. However, we choice of treatment modalities. Our with modifications. Specifically, we are concluded that these modalities lack concern in the proposed rule was that codifying in our regulation at clear definitions in the literature and there was not a clear, universally § 512.365(b)(1) that the denominator of delivery of care for these modalities is accepted definition of self-care dialysis the home dialysis rate for ESRD billed through the same codes as in- in the literature or a clear way for CMS facilities will be the total dialysis center HD, making it impossible for to identify these claims. However, treatment beneficiary years for CMS to identify the relevant claims. commenters pointed out that there is an attributed ESRD Beneficiaries during the

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MY, as proposed. We are codifying in beneficiary year is comprised of 12 impossible for CMS to identify the our regulation at § 512.365(b)(1) that the beneficiary months. We noted that we relevant claims. numerator of the home dialysis rate for would identify maintenance dialysis The following is a summary of the ESRD facilities will be the total number months based on claims, specifically comments received on the home of dialysis treatment beneficiary years claims with CPT® codes 90957, 90958, dialysis rate calculation for Managing during the MY in which attributed 90959, 90960, 90961, 90962, 90965, or Clinicians and our responses. ESRD Beneficiaries received 90966. CPT® codes 90957, 90958, Comment: Many commenters maintenance dialysis at home, as 90959, 90960, 90961, and 90962 are for suggested including self-care in-center identified by claims with Type of Bill ESRD-related services furnished dialysis patients in the numerator of the 072X, with condition codes 74 or 76. monthly, and indicate beneficiary age home dialysis rate calculation for ESRD While we proposed to include claims (12–19 years of age or 20 years of age facilities using condition code 72, and with condition code 75, we are no and older) and the number of face-to- one of these commenters suggested longer including these claims because face visits with a physician or other removing these patients from the we have since learned that this qualified health care professional per denominator of the home dialysis rate condition code is no longer valid. month (1, 2–3, 4 or more). CPT® codes calculation so that these patients do not Additionally, in this final rule, we will 90965 and 90966 are for ESRD related count against the ESRD facilities or not include claims with condition code services for home dialysis per full Managing Clinicians. CMS received a 80, as proposed, because condition code month, and indicate the age of the letter from a coalition of 26 stakeholders 80 indicates billing for a patient who beneficiary (12–19 years of age or 20 including nephrologists, dialysis received dialysis services at home and years of age and older). Taken together, facilities, patients, and manufacturers the patient’s home is a SNF or nursing these codes are used to bill the MCP for urging that the definition of self-dialysis facility, and we are excluding beneficiaries aged 18 or older, including be further clarified beyond what is beneficiaries residing in or receiving patients who dialyze at home and already present in 42 CFR 494.10 and dialysis in a SNF or nursing facility patients who dialyze in-center. that self-dialysis should be included in from attribution to ETC Participants for As proposed, the numerator for the the numerator for the ETC Model and be purposes of the PPA calculation home dialysis rate for Managing monitored using condition code 72 generally, as described elsewhere in this Clinicians would be the total number of since self-care in-center dialysis is final rule. We are further modifying this dialysis treatment beneficiary years tracked through this code. proposal to also include one half of the during the MY in which attributed Response: CMS appreciates the total number of dialysis treatment ESRD Beneficiaries received commenters’ suggestions for identifying beneficiary years during the MY in maintenance dialysis at home. Home self-care in-center dialysis patients. We which attributed ESRD Beneficiaries dialysis treatment beneficiary years agree with commenter feedback that received maintenance dialysis via self- included in the numerator would be self-dialysis can be identified with dialysis, as identified by claims with composed of those months during condition code 72. We also appreciate Type of Bill 072X and condition code which an attributed ESRD Beneficiary that self-dialysis may serve as a way to 72, and are clarifying that self-dialysis received maintenance dialysis at home, provide a gradual transition from in- treatment beneficiary years included in such that one beneficiary year is center dialysis to home dialysis, the numerator are those months in comprised of 12 beneficiary months. We allowing patients to become comfortable which attributed ESRD Beneficiaries would identify maintenance dialysis at with conducting dialysis under medical received self-dialysis in-center, such home months based on claims, supervision. We considered including that one beneficiary year is comprised of specifically claims with CPT® codes self-dialysis in the numerator of the 12 beneficiary months. Of note, we have 90965 or 90966. CPT® code 90965 is for proposed rule, pointing out that it was removed references to the risk ESRD related services for home dialysis consistent with the overarching goals of adjustment methodology as we are not per full month for patients 12–19 years the ETC Model and helped to promote finalizing the proposed risk adjustment of age. CPT® code 90966 is for ESRD beneficiary choice of treatment methodology for the home dialysis rate related services for home dialysis per modalities. The concern we expressed for ESRD facilities, as described in full month for patients 20 years of age in the proposed rule was that there was section IV.C.5.c.(3) of this final rule. We and older. These two codes are used to not a clear, consistent definition of self- are also modifying references to the bill the MCP for beneficiaries aged 18 dialysis in the literature or a clear way proposed reliability adjustment and older who dialyze at home. for CMS to identify these claims. methodology and are replacing them Information used to calculate the However, comments from stakeholders with references to the aggregation Managing Clinician home dialysis rate point out that there is an already methodology for the home dialysis rate includes Medicare claims data and defined claim code in the ESRD PPS for ESRD facilities, as described in Medicare administrative data. and a clear definition in federal law at section IV.C.5.c.(4) of this final rule. In the proposed rule, we considered 42 CFR 494.10. including beneficiaries whose dialysis After considering public comments, (b) Home Dialysis Rate for Managing modality is self-dialysis or temporary we are finalizing our proposed Clinicians PD furnished in the ESRD facility at a provisions on the home dialysis rate We proposed that the denominator of transitional care unit in the numerator, calculation for Managing Clinicians, the home dialysis rate for Managing given that these modalities align with with modification. Specifically, we are Clinicians would be the total dialysis one of the overarching goals of the codifying in our regulation at treatment beneficiary years for proposed ETC Model, to increase § 512.365(b)(2) that the denominator of attributed ESRD Beneficiaries during the beneficiary choice regarding ESRD the home dialysis rate for Managing MY. Dialysis treatment beneficiary years treatment modality. However, we noted Clinicians will be the total dialysis included in the denominator would be in the proposed rule that these treatment beneficiary years for composed of those months during modalities lack clear definitions in the attributed ESRD Beneficiaries during the which an attributed ESRD Beneficiary literature and delivery of care for these MY, as proposed. We are codifying in received maintenance dialysis at home modalities is billed through the same our regulation at § 512.365(b)(2) that the or in an ESRD facility, such that one codes as in-center HD, making it numerator of the home dialysis rate for

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Managing Clinicians will be the total facilities as described in the proposed found in the CY 2019 ESRD PPS final number of dialysis treatment beneficiary rule and section IV.C.5.c.(2)(a) of this rule (83 FR 56922, 57003–08). We years during the MY in which attributed final rule, and for ETC Participants who solicited comment on our proposal to ESRD Beneficiaries received are Managing Clinicians as described in not test the effectiveness of the Model’s maintenance dialysis at home, as the proposed rule and section incentives on increasing the number of identified by CPT® codes 90965 or IV.C.5.c.(2)(b) of this final rule. patients added to the kidney transplant 90966; however, we are modifying this For purposes of constructing the waitlist. Additionally, we solicited proposal to also include one half of the transplant rate, we proposed two comment on an alternative transplant total number of dialysis treatment transplant rate-specific beneficiary waitlist measure that would also capture beneficiary years during the MY in exclusions. Specifically, we proposed to living donation. which attributed ESRD Beneficiaries exclude an attributed beneficiary from We proposed using one year of data, received maintenance dialysis via self- the transplant rate calculations for any from an MY, to construct the transplant dialysis. Specifically, each beneficiary months during which the beneficiary rate to align with the construction of the month for which an attributed was 75 years of age or older at any point home dialysis rate. However, we noted beneficiary receives self-dialysis will during the month, and for any months that because transplants are rare events contribute one half month to the in which the beneficiary was in a SNF for statistical purposes, we may not numerator. Self-dialysis treatment at any point during the month. We have sufficient statistical power to beneficiary years included in the proposed these additional exclusions to detect meaningful variation using only numerator are composed of those recognize that, while these beneficiaries one year of performance information at months during which an attributed can be candidates for home dialysis, the ETC Participant level. In order to ESRD Beneficiary received self-dialysis they are generally not considered ensure that we would have sufficient in center, such that one beneficiary year candidates for transplantation. As we statistical power to detect meaningful is comprised of 12 beneficiary months. noted in the proposed rule, these variation in performance, in the Months in which an attributed ESRD exclusions would be similar to the proposed rule we also considered the Beneficiary received self-dialysis will be exclusions used in the PPPW measure alternative of using 2, 3, or 4 years of identified by claims with Type of Bill that has been adopted by the ESRD QIP. data, corresponding with the MY plus 072X, with condition code 72. We are We sought comment on the proposal to the calendar year or years immediately using condition code 72 because self- exclude from the transplant rate prior to the MY, to construct the dialysis cannot be identified using CPT® beneficiaries aged 75 or older and transplant rate. However, we wanted to codes submitted by Managing beneficiaries in SNFs. The transplant avoid adjusting ETC Participant Clinicians. We are making this change rate calculations would also exclude payment based on performance that for consistency with the modifications beneficiaries who elected hospice, as we occurred prior to the implementation of made to the home dialysis rate proposed to exclude beneficiaries who the ETC Model, if finalized, and calculation for ERSD facilities in have elected hospice from attribution concluded that the proposed reliability response to comments, and similarly generally under the ETC Model and adjustment aggregation methodology, believe this policy change, as applied to therefore they would be excluded from described in the proposed rule and the home dialysis rate for Managing the calculation of both the transplant section IV.C.5.c.(4) of this final rule, Clinicians, will effectively balance the rate and the home dialysis rate. would compensate for any lack of benefits of self-dialysis and its ability to In the proposed rule, we considered statistical power, and would therefore help beneficiaries transition to home using rates of transplant waitlisting eliminate the need to include data from dialysis with the recognition that it is rather than the actual transplant rate. calendar years prior to the MY in order not home dialysis and does not have all However, for the ETC Model, we to produce a reliable and valid of the same benefits. Of note, we have proposed to test the effectiveness of the transplant rate. We discuss later in this removed references to the risk Model’s incentives on outcomes, rather final rule our proposal for risk adjusting adjustment methodology because we are than on processes. We stated in the and reliability adjusting these rates. not finalizing the proposed risk proposed rule that the relevant outcome The following is a summary of the adjustment methodology for the home for purposes of the ETC Model is the comments received on the use of the dialysis rate for Managing Clinicians, as receipt of a kidney or kidney-pancreas transplant rate and the alternatives described in section IV.C.5.c.(3) of this transplant, not getting on and remaining considered, and our responses. final rule. We are also modifying on the kidney transplant waitlist. While Comment: Several commenters agreed references to the proposed reliability we acknowledged in the proposed rule with CMS’s proposal to use adjustment methodology and are that getting a beneficiary on the transplantation to assess ESRD facility replacing them with references to the transplant waitlist is more directly performance on the transplant rate since aggregation methodology for the home influenced by the ESRD facility and/or transplantation generally provides the dialysis rate for Managing Clinicians, as the Managing Clinician than the best outcomes for patients and promotes described in section IV.C.5.c.(4) of this beneficiary actually receiving the collaboration for transplant efforts. final rule. transplant, we stated that we believed Some of these same commenters that ESRD facilities and Managing suggested that increasing the number of (2) Transplant Rate Clinicians are well positioned to assist patients on the transplant waitlist may We proposed to define the ‘‘transplant beneficiaries through the transplant not correlate with an increase in rate’’ as the rate of ESRD Beneficiaries process, and we wanted to incentivize transplantation rates. Instead of the and, if applicable, pre-emptive this focus. We also acknowledged in the transplant rate, some commenters transplant beneficiaries attributed to the proposed rule that transplant waitlist suggested a focus on patient education ETC Participant who received a kidney measures do not capture living around treatment modality choices or or kidney-pancreas transplant during donation, which is an additional path to the transplant process. However, the MY, as described in proposed a successful kidney transplant, and multiple other commenters stated that § 512.365(c) (Transplant Rate). We ESRD facilities and Managing Clinicians they are concerned that complexities proposed to construct the transplant rate may support this process. Details about outside of health care providers’ and for ETC Participants that are ESRD the PPPW Clinical Measure can be patients’ control, including policy

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barriers, lack of available organs, which on deceased donor organ supply before Comment: Several commenters is often due to the way deceased organs holding ETC Participants accountable recommended that we exclude are procured, long waitlist times, patient for their performance on the transplant beneficiaries in SNFs from our choice, and the lack of a clinical fit for rate that includes deceased donor organ calculation of the transplant rate. Other transplant do not support the proposed transplants. It is our intent to observe commenters stated that CMS should methodology to assess ETC Participant the supply of deceased donor organs factor the longevity of the organ performance based on a transplant rate. available for transplantation. Any transplant into the transplant rate. A Some commenters instead suggested change to the composition of the commenter stated that CMS should add using the PPPW measure and transplant rate to include the rate of in beneficiaries who have received a Standardized First Kidney Transplant deceased donor kidney transplants for transplant into the denominator of the Waitlist Ratio for Incident Dialysis the purposes of the PPA calculation transplant rate calculation. Several Patients (SWR) measure, but pointed out under the Model would be established commenters suggesting removing from that the SWR does not include pre- through future rulemaking. the denominator of the transplant rate emptive transplants in its data and that We also sought comment on an calculation those beneficiaries who are the PPPW measures prevalence of alternative transplant waitlist measure ineligible for transplant. beneficiaries on the waitlist, which that would capture living donation, Response: CMS appreciates the includes beneficiaries who have been on which is an alternative path to a feedback. CMS is now excluding ESRD the waitlist for a long duration and may successful kidney transplant. We did Beneficiaries who reside in or receive not account for other barriers to not receive any suggestions of dialysis at a SNF or nursing home alternative measures of transplant transplantation. facility from attribution to ETC waitlisting that would capture living Response: CMS appreciates this Participants for purposes of calculating donation. However, we wanted to feedback. In the proposed rule, we the PPA, as described in section recognize the important role that ETC specifically solicited comment on our IV.C.5.b.(1) of this final rule, and Participants, as ESRD facilities and proposal not to test the effectiveness of therefore these beneficiaries will be Managing Clinicians, can play in the Model’s incentives on increasing the excluded from the calculation of the increasing the rates of living donor number of patients added to the transplant rate well as the home dialysis kidney transplants outside the transplant waitlist. We appreciate rate. We believe that the beneficiary transplant waitlist process and are attribution exclusions as well as not commenters concerns that certain keeping living donor transplants in the factors that impact the transplant rate transplant rate calculation alongside the including beneficiaries over the age of are beyond the control of the ETC transplant waitlist rate, instead of 75 in the transplant rate calculation Participant, particularly regarding the deceased donor transplants as was in remove the majority of beneficiaries supply of deceased donor organs the proposed rule. We define the ‘‘living who are ineligible for transplantation available for transplantation. While we donor transplant rate’’ as the rate of from the denominator of the transplant believe that other efforts intended to ESRD Beneficiaries and, if applicable, rate. In addition, because we are increase the supply of deceased donor Pre-emptive LDT Beneficiaries modifying our proposal and will use the organs, including the ETC Learning attributed to the ETC Participant who transplant rate calculated as the sum of Collaborative (described in section received a kidney transplant from a the transplant waitlist rate and the IV.C.12 of this final rule) and extending living donor during the MY. living donor transplant rate rather than the Kidney Disease Education benefit to To accommodate this change, we are the transplant rate including deceased multiple provider types (described in modifying the definition of the donor transplants, the longevity of the section IV.C.7.b of this final rule) will ‘‘transplant rate’’ as the sum of the organs is no longer a relevant help to address this concern, we also transplant waitlist rate and the living consideration. If the transplant rate acknowledge that these efforts will take donor transplant rate. We define the originally proposed is adopted for later time to produce results. As such, we are ‘‘transplant waitlist rate’’ as the rate of years of the Model through subsequent modifying our proposed transplant rate ESRD Beneficiaries attributed to the rulemaking, CMS may consider and will instead use a transplant rate ETC Participant who were on the kidney incorporating organ longevity as part of that is calculated as the sum of the transplant waitlist during the MY, as the transplant rate and/or altering the transplant waitlist rate and the living described in § 512.365(c)(1)(i) and denominator of the transplant rate donor transplant rate for purposes of the § 512.365(c)(2)(i). We acknowledge that calculation in a manner suggested by PPA calculation under the Model. This there are existing transplant waitlist the commenters, and would solicit policy change aligns with suggestions measures, including the PPPW and SWR public comment on such a change from commenters that, particularly in identified by commenters. However, we through a future notice of proposed light of the current shortage of deceased believe that constructing a transplant rulemaking. We also note that organ donor organs for transplant, a transplant waitlist rate specific to the ETC Model longevity is a consideration for the KCC waitlist rate is more within the control is the best approach. The transplant Model, which is testing the efficacy of of the ETC Participant. This approach waitlist rate for the ETC Model is payment incentives on post-transplant will allow the changes made by the similar in concept to the PPPW but uses care via a kidney transplant bonus. proposed rule issued December 23, 2019 the attribution methodology specific to Through this kidney transplant bonus, entitled Organ Procurement the ETC Model. As noted previously in CMS aims to test the impact of making Organizations Conditions for Coverage: this final rule, we may seek to modify a payment reward to model participants Revisions to the Outcome Measure the ETC Model in the future to use a for each aligned beneficiary who Requirements for Organ Procurement transplant rate that includes deceased receives a kidney transplant. This (CMS–3380–P) and the proposed rule donor transplants, and would do so kidney transplant bonus payment would published December 20, 2019 entitled through subsequent rulemaking. In the be made in each of the three years Removing Financial Disincentives to final rule, we are clarifying that CMS following the transplant in which the Living Organ Donation, if finalized, as will obtain data about the kidney transplant remains successful, meaning well as the ETC Learning Collaborative transplant waitlist from SRTR, which the beneficiary does not return to under the Model time to have an effect maintains all transplant waitlists. dialysis.

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In terms of the recommendation that the aforementioned exclusions. Dialysis and Medicare administrative data about CMS add in beneficiaries who have treatment beneficiary years included in the occurrence of kidney and kidney- received a transplant into the the denominator would be composed of pancreas transplants not identified denominator of the transplant rate those months during which attributed through claims. If a beneficiary who calculation, as described elsewhere in ESRD Beneficiaries received receives a transplant during a MY this final rule, CMS is modifying the maintenance dialysis at home or in an returns to dialysis during the same MY, definition of ESRD Beneficiary to clarify ESRD facility, such that 1 beneficiary the beneficiary would remain in the that a beneficiary who has received a year would be comprised of 12 numerator. kidney transplant would be considered attributed beneficiary months. Months In the proposed rule, we also an ESRD Beneficiary (and therefore during which an attributed ESRD considered constructing the numerator included in the denominator of the Beneficiary received maintenance for the ESRD facility transplant rate transplant waitlist rate and the living dialysis would be identified by claims such that the number of attributed donor transplant rate) if the beneficiary with Type of Bill 072X. We explained beneficiaries who received transplants either: (1) Has a dialysis or MCP claim in the proposed rule that Facility code during a MY would remain in the at least 12 months after the beneficiary’s 7 paired with type of care code 2, numerator for every MY after the latest transplant date; or (2) has a indicates that the claim occurred at a transplant during which the dialysis or MCP claim less than 12 clinic or hospital based ESRD facility. transplanted beneficiary does not return months after the beneficiary’s latest Type of Bill 072X captures all renal to dialysis, for the duration of the transplant date that includes a kidney dialysis services furnished at or through proposed ETC Model. Keeping transplant failure diagnosis code ESRD facilities. However, in order to attributed beneficiaries who received documented in any Medicare claim. effectuate the exclusions previously transplants in a MY in the numerator for These beneficiaries also would be described, we would exclude claims for MYs subsequent to the MY in which the included in the numerator of the attributed ESRD Beneficiaries who were transplant occurs would acknowledge transplant waitlist rate if the beneficiary 75 years of age or older at any point the significant efforts made by ESRD is added to the kidney transplant during the month or were in a SNF at facilities to successfully assist waitlist, and in the numerator of the any point during the month. beneficiaries through the transplant living donor transplant rate if the process. However, as noted in the We proposed that the numerator for beneficiary received a transplant from a proposed rule, we believe this approach the transplant rate for ESRD facilities living donor. would artificially inflate transplant rates After considering public comments, would be the total number of attributed in later years of the Model and we are finalizing our general proposal beneficiaries who received a kidney disproportionately disadvantage new on the transplant rate, with transplant or a kidney-pancreas ESRD facilities who begin providing modifications. Specifically, in response transplant during the MY. We would care to ESRD Beneficiaries in later years to comments received, we are replacing identify kidney and kidney-pancreas of the Model. In the proposed rule we the transplant rate we had proposed to transplants using Medicare claims data, concluded that this potential for use for purposes of calculating the PPA Medicare administrative data, and SRTR artificially inflated rates and the with the transplant rate calculated as data. For Medicare claims data, we disadvantage that would result for new the sum of the living donor transplant would use claims with Medicare ESRD facilities outweighed the rate that had been included as part of Severity Diagnosis Related Groups (MS– advantage of accruing transplants over the original transplant rate calculation DRGs) 008 (simultaneous pancreas- time. and the transplant waitlist rate on kidney transplant) and 652 (kidney The following is a summary of the which we had solicited comments. In transplant); and claims with ICD–10 comments received on the proposed addition, we are not finalizing the procedure codes 0TY00Z0 transplant rate for ESRD facilities and definition of transplant rate as (transplantation of right kidney, our responses. proposed. Rather, in our regulation at allogeneic, open approach), 0TY00Z1 Comment: Multiple commenters § 512.310, we are modifying the (transplantation of right kidney, mentioned that ESRD facilities can definition of ‘‘transplant rate’’ to mean syngeneic, open approach), 0TY00Z2 control only evaluation and referral of the sum of the transplant waitlist rate (transplantation of right kidney, patients to transplant centers. A and the living donor transplant rate. We zooplastic, open approach) 0TY10Z0 commenter suggested that ETC are defining the term ‘‘transplant (transplantation of left kidney, Participants be required to refer any waitlist rate’’ to mean the rate of ESRD allogeneic, open approach), 0TY10Z1 patient with an Estimated Post Beneficiaries attributed to the ETC (transplantation of left kidney, Transplant Survival (EPTS) Score of 75 Participant who were on the kidney syngeneic, open approach), and percent or below to receive a transplant transplant waitlist during the MY, as 0TY10Z2 (transplantation of left kidney, evaluation. described in § 512.365(c). We are also zooplastic, open approach). Because Response: We appreciate the feedback defining the term ‘‘living donor kidney-pancreas transplants are billed from the commenters. As described in transplant rate’’ to mean the rate of by including an ICD–10 procedure code section IV.C.5 of this final rule, we ESRD Beneficiaries and, if applicable, for the type of kidney transplant and a appreciate the complexity of the Pre-emptive LDT Beneficiaries separate ICD–10 procedure code for the transplant process, including the attributed to the ETC Participant who type of pancreas transplant, in the number of transplant providers involved received a kidney transplant from a proposed rule we determined that we and the different roles they play. For living donor during the MY. would not need to include additional this reason, we are modifying our ICD–10 codes to capture kidney- proposal and will instead use a (a) Transplant Rate for ESRD Facilities pancreas transplants beyond the ICD–10 transplant rate calculated as the sum of For ESRD facilities, we proposed that codes for kidney transplants listed. We the transplant waitlist rate and the the denominator for the transplant rate proposed that we would supplement living donor transplant rate for purposes would be the total dialysis treatment Medicare claims data on kidney and of calculating the Facility PPA. As the beneficiary years for attributed ESRD kidney-pancreas transplants with health care providers that ESRD Beneficiaries during the MY, subject to information from the SRTR Database beneficiaries see most frequently, ESRD

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facilities play a pivotal role in the living SRTR, which maintains data on all methodology and are replacing them donor and transplant waitlist process, transplant waitlists. with references to the aggregation including: Educating beneficiaries about The denominator for the living donor methodology for the transplant rate for their transplant options, including transplant rate for ESRD facilities will ESRD facilities, as described in section living donation; helping beneficiaries be calculated in the same manner as the IV.C.5.c.(4) of this final rule. navigate the transplant process, denominator for the transplant waitlist rate finalized for ESRD facilities. The (b) Transplant Rate for Managing including helping beneficiaries Clinicians understand the process; providing numerator for the living donor referrals for care necessary to meet transplant rate for ESRD facilities is the As we noted in the proposed rule, clinical transplant requirements, and total number of attributed beneficiary whereas ESRD facilities provide care to referrals for transplant waitlisting; and years for LDT Beneficiaries during the beneficiaries only once they have begun coordinating care during the transplant MY. Beneficiary years for LDT dialysis, Managing Clinicians provide process. Beneficiaries included in the numerator care for beneficiaries before they begin As noted previously in this final rule, are composed of the number of months dialysis. Therefore, we proposed to use we may seek to modify the ETC Model from the beginning of the MY up to and a numerator and denominator for the through subsequent rulemaking to use a including the month of the transplant transplant rate for Managing Clinicians transplant rate that incorporates the rate for LDT Beneficiaries attributed to the that would include pre-emptive of deceased donor transplants. ESRD facility during the month of the transplant beneficiaries, that is, beneficiaries who receive transplants After considering public comments, transplant. This method of determining before beginning dialysis, in addition to we are finalizing our proposed the number of months associated with a ESRD Beneficiaries. In this construction, provisions on the transplant rate for LDT mirrors the method for determining a pre-emptive transplant beneficiary ESRD facilities in our regulations at beneficiary attribution for pre-emptive would be included in the numerator for § 512.365(c)(1), with modifications. transplant beneficiaries included in the the Managing Clinician as a transplant Specifically, in response to comments proposed rule and for determining beneficiary attribution for Pre-emptive and in the denominator for the received, the transplant rate for ESRD LDT Beneficiaries as described in Managing Clinician for the number of facilities is calculated as the sum of the section IV.C.5.b.(2)(b) of this final rule. months from the beginning of the MY transplant waitlist rate for ESRD This method is necessary in order to up to and including the month of the facilities and the living donor transplant transform a singular event, in particular transplant. In the proposed rule, we rate for ESRD facilities. As was the case receipt of a living donor transplant, into considered including pre-emptive with the proposed transplant rate for a number of beneficiary months such transplants during the MY among ESRD facilities, the denominator for the that the numerators for the transplant attributed pre-emptive transplant transplant waitlist rate for ESRD waitlist rate and the living donor beneficiaries in the numerator, to facilities and the living donor transplant transplant rate can be combined into the acknowledge Managing Clinician efforts rate for ESRD facilities is the total transplant rate. CMS will obtain living in assisting ESRD Beneficiaries with dialysis treatment beneficiary years for donor transplant data from SRTR, which pre-emptive transplants, without attributed ESRD Beneficiaries during the maintains data on all transplant, including them in the denominator. MY. Dialysis treatment beneficiary years including living donor transplants, and However, we concluded that this would included in the denominator are from Medicare claims. We would disproportionately favor pre-emptive composed of those months during identify kidney transplants using transplants in the construction of the which attributed ESRD Beneficiaries Medicare claims and administrative rate. We sought comment on the received maintenance dialysis at home data, and SRTR data. As was the case in proposed inclusion of pre-emptive or in an ESRD facility, such that 1 the proposed rule, to identify kidney transplants in both the numerator and beneficiary year is comprised of 12 transplants using Medicare claims data, the denominator for the Managing attributed beneficiary months. Months we will use claims with Medicare Clinician transplant rate calculation. during which an attributed ESRD Severity Diagnosis Related Groups (MS– We proposed that the denominator for Beneficiary received maintenance DRGs) 008 (simultaneous pancreas- the transplant rate for Managing dialysis are identified by claims with kidney transplant) and 652 (kidney Clinicians would be the total dialysis Type of Bill 072X. Beneficiaries who are transplant); and claims with ICD–10 treatment beneficiary years for 75 years of age or older at any point procedure codes 0TY00Z0 attributed ESRD Beneficiaries during the during the month are excluded from the (transplantation of right kidney, MY, plus the total number of attributed denominator. Because beneficiaries who allogeneic, open approach), 0TY00Z1 beneficiary years for pre-emptive reside in SNFs or nursing facilities are (transplantation of right kidney, transplant beneficiaries during the MY. now excluded from attribution to ETC syngeneic, open approach), 0TY00Z2 Dialysis treatment beneficiary years Participants for purposes of the PPA (transplantation of right kidney, included in the denominator would be calculation in general, it is not zooplastic, open approach) 0TY10Z0 composed of those months during necessary to specifically exclude (transplantation of left kidney, which an attributed ESRD Beneficiary beneficiaries who were in a SNF from allogeneic, open approach), 0TY10Z1 received maintenance dialysis at home the transplant waitlist rate denominator, (transplantation of left kidney, or in an ESRD facility, such that one as we had proposed to do for purposes syngeneic, open approach), and beneficiary year is comprised of 12 of the transplant rate. 0TY10Z2 (transplantation of left kidney, beneficiary months. Months during The numerator for the transplant zooplastic, open approach) We are also which an attributed ESRD Beneficiary waitlist rate for ESRD facilities is the defining LDT Beneficiary in our received maintenance dialysis would be number of beneficiary years for which regulations at § 512.310 to mean an identified based on claims, specifically attributed ESRD Beneficiaries were on ESRD Beneficiary who received a claims with CPT® codes 90957, 90958, the kidney transplant waitlist during the kidney transplant from a living donor 90959, 90960, 90961, 90962, 90965, or MY. As noted previously, we are during the MY. 90966. CPT® codes 90957, 90958, clarifying in this final rule that CMS Of note, we are modifying references 90959, 90960, 90961, and 90962 are for will obtain transplant waitlist data from to the proposed reliability adjustment ESRD related services monthly, and

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indicate beneficiary age (12–19 or 20 allogeneic, open approach), 0TY00Z1 advantage of accruing transplants over years of age or older) and the number of (transplantation of right kidney, time. face-to-face visits with a physician or syngeneic, open approach), 0TY00Z2 The following is a summary of the other qualified health care professional (transplantation of right kidney, comments received on the proposed per month (1, 2–3, 4 or more). CPT® zooplastic, open approach) 0TY10Z0 transplant rate for Managing Clinicians codes 90965 and 90966 are for ESRD (transplantation of left kidney, and our responses. related services for home dialysis per allogeneic, open approach), 0TY10Z1 Comment: We received one comment full month, and indicate the age of the (transplantation of left kidney, recommending that CMS include claims beneficiary (12–19 or 20 years of age or syngeneic, open approach), and for beneficiaries who have received a older). Taken together, these codes are 0TY10Z2 (transplantation of left kidney, transplant in the numerator of the transplant rate for Managing Clinicians, used to bill the MCP, including patients zooplastic, open approach). Because even for the MYs after the transplant, to who dialyze at home and patients who kidney-pancreas transplants are billed give Managing Clinicians credit for dialyze in-center. However, in order to by including an ICD–10 procedure code helping to manage patient care and effectuate the exclusions previously for the type of kidney transplant and a described, we proposed to exclude improve post-transplant outcomes for separate ICD–10 procedure code for the these beneficiaries. claims for attributed ESRD Beneficiaries type of pancreas transplant, we who were 75 years of age or older at any Response: We appreciate the feedback concluded that we would not need to point during the month or were in a from the commenter. As we are include additional ICD–10 codes to SNF at any point during the month. modifying the transplant portion of the For pre-emptive transplant capture kidney-pancreas transplants MPS used in calculating the PPA to use beneficiaries, attributed beneficiary beyond the ICD–10 codes for kidney the transplant rate calculated as the sum years included in the denominator transplants listed. We proposed that we of the transplant waitlist rate and the would be composed of those months would supplement Medicare claims living donor transplant rate, instead of during which a pre-emptive transplant data on kidney and kidney-pancreas the transplant rate as proposed, we do beneficiary is attributed to the Managing transplants with information from the not believe it would be appropriate to Clinician, between the start of the MY SRTR Database and Medicare include beneficiaries in the transplant and the month of the transplant. In the administrative data about the waitlist rate calculation post-transplant, proposed rule we recognized that occurrence of kidney and kidney- as there would generally be no need for including pre-emptive transplant pancreas transplants not identified Managing Clinicians to add these beneficiary years in the denominator through claims. We stated that if a beneficiaries to a transplant waitlist. We may create a bias in favor of pre-emptive beneficiary who receives a transplant also do not believe it would be transplants occurring at the beginning of during an MY returns to dialysis during necessary to include post-transplant the MY, which may influence Managing the same MY, the beneficiary would LDT Beneficiaries or Pre-emptive LDT Clinician behavior. As pre-emptive remain in the numerator, to Beneficiaries in the living donor transplant beneficiaries only contribute acknowledge the efforts of the Managing transplant rate beyond the MYs in months to the denominator from the Clinician in facilitating the transplant which the transplant occurs, as the start of the MY to the month of the but also to hold the Managing Clinician focus of the rate is whether or not a transplant, the earlier in the MY the harmless for transplant failure, which transplant occurred, not what occurs transplant occurs, the fewer months are may be outside of the Managing post-transplant. However, if we modify included in the denominator, and the Clinician’s control. the MPS calculation to use a transplant higher the Managing Clinician’s rate that includes deceased donor In the proposed rule we also transplants or a similar measure for transplant rate. However, as noted in the considered constructing the numerator proposed rule, we believed that the future MYs through subsequent for the Managing Clinician transplant rulemaking, we may consider proposing potential for this bias to impact rate such that the number of attributed Managing Clinician behavior is small to incorporate post-transplant outcomes beneficiaries who received transplants due to the complexity of scheduling in through such subsequent rulemaking. during a MY would remain in the the pre-emptive transplant process After considering public comments, numerator for every MY after the (such as surgeon availability, donor and we are finalizing our proposed transplant for which the transplanted recipient schedules, etc.). provisions on the transplant rate for We proposed that the numerator for beneficiary does not return to dialysis, Managing Clinicians in our regulation at the transplant rate for Managing for the duration of the ETC Model. § 512.356(c)(2), with modification. The Clinicians would be the number of Keeping transplants in the numerator transplant rate for Managing Clinicians attributed ESRD Beneficiaries who for MYs subsequent to the MY in which is calculated as the sum of the received a kidney transplant or a the transplant occurs would transplant waitlist rate for Managing kidney-pancreas transplant during the acknowledge the significant efforts Clinicians and the living donor MY, plus the number of pre-emptive made by Managing Clinicians to transplant rate for Managing Clinicians. transplant beneficiaries attributed to the successfully assist beneficiaries through The denominator for the transplant Managing Clinician for the MY. We the transplant process. However, as waitlist rate for Managing Clinicians is proposed to identify kidney and kidney- noted in the proposed rule, we believed the total dialysis treatment beneficiary pancreas transplants using Medicare this approach would artificially inflate years for attributed ESRD Beneficiaries claims data, Medicare administrative transplant rates in later years of the during the MY. As was the case with the data, and SRTR data. For Medicare Model and disproportionately proposed transplant rate for Managing claims data, we would use claims with disadvantage new Managing Clinicians Clinicians, dialysis treatment Medicare Severity Diagnosis Related who begin providing care to ESRD beneficiary years included in the Groups (MS–DRGs) 008 (simultaneous Beneficiaries in later years of the Model. denominator are composed of those pancreas-kidney transplant) and 652 We concluded that this potential for months during which attributed ESRD (kidney transplant); and claims with artificially inflated rates and the Beneficiaries received maintenance ICD–10 procedure codes 0TY00Z0 disadvantage that would result for new dialysis at home or in an ESRD facility, (transplantation of right kidney, ESRD facilities outweighed the such that 1 beneficiary year is

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comprised of 12 attributed beneficiary rate includes only pre-emptive with references to the aggregation months. Months during which an transplants that came from living methodology for the transplant rate for attributed ESRD Beneficiary received donors. As such, the denominator for Managing Clinicians, as described in maintenance dialysis are identified the living donor transplant rate for section IV.C.5.c.(4) of this final rule. based on claims, specifically claims Managing Clinicians does not include (3) Risk Adjustment with CPT® codes 90957, 90958, 90959, beneficiaries who received a pre- 90960, 90961, 90962, 90965, or 90966. emptive transplant from a deceased In order to account for underlying Beneficiaries who are 75 years of age or donor. Dialysis treatment beneficiary variation in the population of older at any point during the month are years included in the denominator of beneficiaries attributed to participating excluded from the denominator. the living donor transplant rate for ESRD facilities and Managing Because beneficiaries who reside in or Managing Clinicians are the same as Clinicians, we proposed that CMS receive dialysis in SNFs or nursing those included in the denominator of would risk adjust both the home facilities during the month are now the transplant waitlist rate, as described dialysis rate and the transplant rate. excluded from attribution in general, we above. As was the case for preemptive For the home dialysis rate, we are also excluding beneficiaries who transplant beneficiary years in the proposed to use the most recent final were residing in or receiving dialysis a proposed rule, pre-emptive LDT risk score for the beneficiary, calculated skilled nursing facility or nursing home beneficiary years included in the using the CMS–HCC (Hierarchical facility from the transplant waitlist rate denominator are composed of those Condition Category) ESRD Dialysis denominator. Of note, the denominator months during which a Pre-emptive Model used for risk adjusting payment for the Managing Clinician transplant LDT Beneficiary is attributed to the in the Medicare Advantage program, to waitlist rate does not include attributed Managing Clinician, between the start of risk adjust the home dialysis rate under the proposed ETC Model. As noted in Pre-emptive LDT Beneficiaries, as these the MY and up to and including the the proposed rule, internal analyses beneficiaries do not have to be on the month of the transplant. The numerator completed by CMS show that lower transplant waitlist to receive their for the living donor transplant rate for HCC risk scores are associated with transplant because living donor organs Managing Clinicians is the total number beneficiaries on home dialysis than with are not allocated through the transplant of attributed beneficiary years for LDT beneficiaries on in-center HD. The risk waitlist. Beneficiaries during the MY plus the adjustment methodology we proposed The numerator for the transplant total number of attributed beneficiary for the ETC Model home dialysis rate waitlist rate for Managing Clinicians is years for Pre-emptive LDT Beneficiaries would account for ESRD facilities and the number of beneficiary years for during the MY. Beneficiary years for Managing Clinicians with a population which attributed ESRD Beneficiaries LDT Beneficiaries included in the were on the kidney transplant waitlist that is relatively sicker than the general numerator are composed of the number Medicare population. As we explained during the MY. We are clarifying in this of months from the beginning of the MY final rule that CMS will identify months in the proposed rule, the CMS–HCC risk up to and including the month of the adjustment models were developed for during which an attributed ESRD transplant for LDT Beneficiaries beneficiary was on the kidney the Medicare Advantage program and attributed to the Managing Clinician use a Medicare beneficiary’s medical transplant waitlist using data from the during the month of the transplant. As SRTR database, which maintains data conditions and demographic described above in regards to the living information to predict Medicare on all transplant waitlists. donor transplant rate for ESRD facilities, The denominator for the living donor expenditures for the next year. In the this method is necessary in order to transplant rate for Managing Clinicians Medicare Advantage context, the per- transform a singular event, in particular is the sum of total dialysis treatment person capitation amount paid to each beneficiary years for attributed ESRD a living donor transplant, into a number Medicare Advantage plan is adjusted Beneficiaries during the MY and the of beneficiary months such that the using a risk score calculated using the total number of attributed beneficiary numerators for the transplant waitlist CMS–HCC Models.152 We proposed to years for attributed Pre-emptive LDT rate and the living donor transplant rate use the most recent final risk score Beneficiaries during the MY. We define can be combined into the transplant calculated for the beneficiary that is a Pre-emptive LDT Beneficiary in our rate. As with the denominator for the available at the time of the calculation regulations at § 512.310 as a beneficiary living donor transplant rate for of ESRD facility and Managing Clinician who received a pre-emptive kidney Managing Clinicians, pre-emptive LDT home dialysis rates to risk adjust the transplant from a living donor during beneficiary years included in the ETC Model home dialysis rate for that the MY. Including Pre-emptive LDT numerator are composed of those MY and corresponding PPA Period. Beneficiaries in the living donor months during which a Pre-emptive In the proposed rule, we summarized transplant rate denominator for LDT Beneficiary is attributed to the at a high level how the CMS–HCC Managing Clinicians follows the same Managing Clinician, between the start of Models are developed and used in risk reasoning and method as described in the MY and up to and including the adjusting payment to Medicare the proposed rule for including pre- month of the transplant. Advantage plans. emptive transplant beneficiaries in the CMS will obtain transplant waitlist We explained that CMS proposes and transplant rate for Managing Clinicians. data from SRTR, which maintains status adopts the CMS–HCC ESRD Dialysis That is, whereas ESRD facilities provide data for all transplant waitlists and Model for risk adjusting payments to care to beneficiaries only once they have transplants, including living donor Medicare Advantage organizations for a begun dialysis, Managing Clinicians transplants. CMS will obtain living particular payment year through the provide care for beneficiaries before donor transplant data from SRTR, which Advance Notice and Rate they begin dialysis. However, the contains comprehensive information Announcement for the Medicare construction of the denominator for the about transplants that occur in the U.S., living donor transplant rate differs from as well as from Medicare claims. Of 152 CMS. Report to Congress: Risk adjustment in Medicare Advantage. December 2018; cms.gov/ the proposed construction of the note, we are modifying references to the Medicare/Health-Plans/ denominator for the proposed transplant proposed reliability adjustment MedicareAdvtgSpecRateStats/Downloads/RTC- rate because the living donor transplant methodology and are replacing them Dec2018.pdf.

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Advantage program.153 This happens ETC Participants that provide care to each reporting month): Under 15; 15–55; the year before the payment year begins, sicker beneficiaries. We also stated that 56–70; and 71–74. Given that the ETC meaning that the CMS–HCC ESRD we considered creating a custom risk- Model would exclude beneficiaries Dialysis Model used to risk adjust adjustment methodology for the ETC under 18 from the attribution payments for 2020 was adopted and Model based on certain factors found in methodology used for purposes of announced in April 2019. However, the literature to affect rates of home calculating the transplant rates, we CMS does not calculate final risk scores dialysis, but said that we believed that proposed to use the risk coefficients for a particular payment year until the HCC system currently in use in the calculated for the PPPW for the several months after the close of the Medicare Advantage program would be populations aged 18–55, 56–70, and 71– payment year. sufficient for the purposes of this 74, with age computed on the last day We explained in the proposed rule Model, without the effort required to of each month of the MY. Transplant that using risk scores developed using develop a new methodology. rates for ESRD facilities and Managing the CMS–HCC ESRD Dialysis Model to We proposed that the risk-adjustment Clinicians would be adjusted to account risk adjust the ETC Model home dialysis methodologies for the home dialysis rate for the relative percentage of the rate would be appropriate as it can be and transplant rate would be applied population of beneficiaries attributed to more difficult to transition sicker independently. In the proposed rule we each ETC Participant in each age beneficiaries to home dialysis, and risk also considered using the same risk category relative to the national age adjusting the home dialysis rate using adjustment strategy for both rates, but distribution of beneficiaries not risk scores calculated using the CMS– recognized that the risk factors that may excluded from attribution. Further HCC ESRD Dialysis Model would impact the ability of an ESRD information on the risk adjustment account for the relative sickness of the Beneficiary to successfully dialyze at model used for purposes of the PPPW population of ESRD Beneficiaries home are different from the risk factors can be found in the PPPW Methodology attributed to each ETC Participant that may impact the ability of an ESRD Report (https://www.cms.gov/Medicare/ relative to the national benchmark. We Beneficiary or pre-emptive transplant Quality-Initiatives-Patient-Assessment- also stated that use of these final risk beneficiary to receive a kidney Instruments/ESRDQIP/Downloads/ scores for the ETC Model would mean transplant. We further noted that, even Report-for-Percentage-of-Prevalent- use of the same methodology and the in the Medicare Advantage program, a Patients-Waitlisted.pdf). same coefficients for the relevant HCCs different CMS–HCC Model is used for In the proposed rule, we stated that as the CMS–HCC ESRD Dialysis Model beneficiaries who have received a we had considered using the risk used for the prior Medicare Advantage transplant and stated our belief that the adjustment methodology used in the payment year. The CMS–HCC ESRD benefit of separate risk adjustment Standardized Waitlist Ratio available Dialysis Model includes the risk factors methodologies would outweigh the online at https://www.cms.gov/ outlined in § 422.308(c)(1) and (c)(2)(ii), additional complexity. For the Medicare/Quality-Initiatives-Patient- so those risk factors would be used in transplant rate, we noted in the Assessment-Instruments/ESRDQIP/ risk adjustment for the ETC Model. proposed rule that we wanted to use a Downloads/Report-for-Standardized- Under our proposal, the risk scores used risk adjustment methodology that aligns First-Kidney-Transplant-Waitlist-Ratio- for the ETC Model would also be with a risk adjustment methodology for-Incident-Dialysis-Facilities.pdf for adjusted with the same coding pattern with which ESRD facilities and risk adjusting the ETC Model transplant and normalization factors that are Managing Clinicians are likely to be rate. However, we decided not to as this adopted for the CMS–HCC ESRD familiar and that similarly would not measure is focused only on incident Dialysis Model for the relevant year but, require development of a new and beneficiaries in their first year of for the ETC Model, we did not propose unfamiliar methodology. In the dialysis, rather than the broader to use a frailty adjustment (for example, proposed rule we noted that we believe population of beneficiaries that would outlined in § 422.308(c)(4)) as is used in that the methodology used for purposes be included in the ETC Model. the Medicare Advantage program for of risk adjusting the PPPW satisfies In the proposed rule we also certain special needs plans. these criteria and would be appropriate considered using the CMS–HCC ESRD In the proposed rule, we also to apply in risk adjusting the transplant Transplant Model for risk adjusting the considered not applying a risk rate. Specifically, we proposed that the ETC Model transplant rate. However, we adjustment methodology to the ETC ESRD facility and Managing Clinician decided not to as the model is focused Model home dialysis rate in recognition transplant rates would be risk adjusted on costs once a beneficiary receives a of the limitations of existing risk for beneficiary age, using the similar age transplant, rather than the beneficiary’s adjustment methodologies to account categories, with corresponding risk suitability for receiving a transplant. for housing instability, which is a key coefficients, used for purposes of the The following is a summary of the factor preventing utilization of home PPPW measure described earlier (83 FR comments received on the risk dialysis. However, we concluded that 57004). adjustment methodology for the home not risk adjusting the home dialysis rate Although age alone is not a dialysis rate, the risk adjustment would disproportionately disadvantage contraindication to transplantation, we methodology for the transplant rate, and stated in the proposed rule that older our responses. 153 For example, CMS, Advance Notice of patients are likely to have more Comment: We received several Methodological Changes for Calendar Year (CY) comorbidities and generally be more comments urging CMS to not use the 2020 for Medicare Advantage (MA) Capitation frail, thus making them potentially less CMS ESRD–HCC Risk Score Rates, Part C and Part D Payment Policies and 2020 suitable candidates for transplantation, methodology for risk adjusting the home Draft Call Letter, January 30, 2019. cms.gov/ Medicare/Health-Plans/MedicareAdvtgSpecRate and therefore some may be dialysis rate as proposed. Many Stats/Downloads/Advance2020Part2.pdf and CMS, appropriately excluded from waitlisting commenters commented that although Announcement of Calendar Year (CY) 2020 for transplantation. The risk adjustment there is a correlation between healthier Medicare Advantage Capitation Rates and Medicare model for the PPPW contains risk beneficiaries and home dialysis Advantage and Part D Payment Policies and Final Call Letter, April 1, 2019; https://www.cms.gov/ coefficients specific to each of the utilization, the relationship is not Medicare/Health-Plans/MedicareAdvtgSpecRate following age categories of beneficiaries causative, nor is beneficiary health Stats/Downloads/Announcement2020.pdf. (with age computed on the last day of status the most important factor

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affecting home dialysis uptake rates. stated that we believed that not risk Response: We thank the commenters Other commenters commented that the adjusting the home dialysis rate would for their recommendations and believe CMS ESRD–HCC Risk Score disproportionately disadvantage ETC that risk adjusting the home dialysis rate methodology is built using fee for Participants that provide care to sicker based on socioeconomic factors may services data to project Medicare beneficiaries. However, our subsequent have merit. However, risk adjusting the Advantage spending, not relative levels analysis indicated that although there is home dialysis rate based on of illness; the commenters also pointed a statistically significant correlation socioeconomic factors would represent out that a beneficiary whose risk score between beneficiary risk scores and a significant departure from the risk is twice that of another is not propensity for home dialysis, the adjustment methodology outlined in the necessarily half as likely to be an relationship had very little explanatory proposed rule. Accordingly, we are not effective candidate for home dialysis. power, meaning that we do not believe finalizing a risk-adjustment Commenters also raised concerns that our proposed risk adjustment methodology based on socioeconomic this proposed methodology was not methodology will help to address this factors at this time. As described transparent as ESRD facilities and issue. We intend to monitor for whether previously in this final rule, we are Managing Clinicians do not necessarily the lack of a risk-adjustment finalizing the home dialysis rate receive the CMS ESRD–HCC risk score methodology for the home dialysis rate calculation without a risk adjustment information for their patients. One has any negative consequences for ETC methodology. We seek input from the dialysis company noted in its comments Participants and ESRD Beneficiaries and public on how to construct a risk that the CMS ESRD–HCC risk score may modify the ETC Model to add a adjustment methodology for the home methodology has a different risk-adjustment methodology for dialysis rate that could account for methodology for beneficiaries who are calculation to the home dialysis rate socioeconomic factors, like the one from new to the Medicare program and that through subsequent rulemaking. the Hospital Readmissions Reduction the HCC risk scores may be less Comment: Many commenters Program, to inform any future predictive for this population given the recommended that CMS consider using rulemaking on this topic. Comment: We received several increased rates of home dialysis socioeconomic factors for purposes of comments critiquing the risk adjustment utilization among beneficiaries who are risk adjusting the home dialysis rate, as methodology from the PPPW measure new to dialysis. these factors can preclude beneficiaries we proposed to apply to the transplant Response: After receiving comments from being appropriate candidates for rate. A commenter raised issues with home dialysis. The commenters asserted on the proposed rule, we performed an the methodology, pointing out that it that beneficiaries suffering from housing additional analysis that showed a was not NQF endorsed and that it risk insecurity or homelessness are not good correlation between lower CMS–HCC adjusts by age in a way that has abrupt candidates for the home dialysis risk scores and an increased likelihood cut points, rather than using age as a modality and that peritonitis, an to receive home dialysis as opposed to continuous variable. in-center dialysis. The average CMS– infection of the perineum that can result Response: We continue to believe that HCC risk score for a beneficiary from PD and prevents beneficiaries from the risk adjustment methodology for the receiving home dialysis is 0.9, while the being able to continue receiving PD is PPPW measure is appropriate to use for average CMS–HCC risk score for a more common among socially the transplant waitlist rate, which we beneficiary receiving in-center disadvantaged groups. Commenters had are finalizing as part of the transplant hemodialysis is 1.03, and this difference several suggestions as to which rate. We extensively tested the PPPW is statistically significant with a p-value socioeconomic factors CMS could use to measure, including its risk adjustment of .02. However, the same analysis done risk-adjust the home dialysis rate, methodology, before we adopted that by CMS after receiving comments on the including using dual eligibility status as measure for the ESRD QIP, and our proposed rule showed that, although the a proxy for socioeconomic status, using rationale supporting the use of a similar difference in CMS–HCC risk scores the ZIP code or the ZIP+4 based on the risk adjustment methodology for the between these two populations is location of the beneficiary or the ESRD transplant waitlist rate is consistent statistically significant, CMS–HCC risk facility, using Z-codes in ICD–10 to with the rationale that supports our use scores have an explanatory ability of track socioeconomic status or of that methodology for the ESRD QIP. only 1.5 percent for determining homelessness, looking at the urban/rural The specific design of the risk whether a beneficiary will receive home divide, using presence on the kidney adjustment methodology for the PPPW dialysis rather than in-center dialysis, transplant waitlist as a proxy for health measure, including the cut points, is and vice versa. Based on the low status, or setting up a standardized ratio designed to best fit the transplant explanatory power of the CMS–HCC risk measure based on projected rates of waitlist data in the PPPW measure. score in predicting whether a transplants. Though it is not an NQF-endorsed beneficiary will receive home dialysis, Three separate commenters— measure, this is a measure currently together with the other issues with the including a dialysis company, a patient used by CMS and we believe the proposed risk-adjustment methodology advocacy group, and a nephrology methodology to be sound. raised by the commentators, we do not practice—each independently Comment: Some commenters asserted believe that there is a significant value recommended that CMS use the risk that the proposed risk adjustment in risk adjusting the home dialysis rate adjustment methodology from the methodology for the transplant rate based on this proposed methodology, Hospital Readmissions Reduction should also include other factors related and therefore we are not finalizing this Program, as laid out in the FY 2018 IPPS to the transplant process, including approach. We are instead finalizing the final rule 154 (82 FR 37990, 38221 diagnoses of malignancy, cardiac home dialysis rate calculation without a (August 14, 2017)) in order to risk-adjust surgery, or other comorbidities that risk-adjustment methodology and we the home dialysis rate for could prevent a beneficiary from being seek input from commenters about risk socioeconomic factors. a transplant candidate. Other adjustment methodologies to be commenters urged CMS to consider proposed in future rulemaking. We 154 https://www.govinfo.gov/content/pkg/FR- other factors related to transplant recognize that in the proposed rule, we 2017-08-14/pdf/2017-16434.pdf. eligibility or to recognize different levels

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of access to kidneys in different (4) Reliability Adjustments and measures would be first aggregated up geographies. Aggregation to the practice level, as identified by the Response: CMS believes that by In order to overcome low reliability of practice Taxpayer Identification modifying the transplant rate to remove the home dialysis rate and transplant Number (TIN) for Managing Clinicians who are in a group practice, and at the deceased donor organ transplants, as rate related to small numbers of individual National Provider Identifier described previously in this final rule, beneficiaries attributed to individual ETC Participants, we proposed to (NPI) level for Managing Clinicians who we do not need to risk adjust the are not in a group practice, that is, solo transplant rate for these specific issues employ a reliability adjustment. Under this approach, we proposed using practitioners. We proposed to define around organ supply that may affect ‘‘TIN’’ as a Federal taxpayer access to kidneys, in particular deceased statistical modeling to make reliability adjustments such that the home dialysis identification number or employer donor organs, in different geographies. identification number as defined by the In addition, though there are disparaties rate and the transplant rate would produce reliable estimates for all ETC Internal Revenue Service in 26 CFR in the transplant process, CMS also Participants, regardless of the number of 301.6109–1. We proposed to define decided not to include other factors in beneficiaries for whom they provide ‘‘NPI’’ as the standard unique health risk adjusting the transplant waitlist rate care. We also proposed this approach to identifier used by health care providers to align with the risk adjustment improve comparisons between ETC for billing payers assigned by the National Plan and Provider methodology for the PPPW measure, Participants and those ESRD facilities Enumeration System (NPPES) in 45 CFR which also did not include these factors. and Managing Clinicians not selected part 162. We proposed these definitions Additionally, we believe that the for participation in the Model for because they are used elsewhere by the exclusions from beneficiary attribution purposes of achievement benchmarking Medicare program (see 42 CFR 414.502). to ETC Participants described in section and scoring, described in the proposed Performance would then be aggregated IV.C.5.b.(1) of this final rule sufficiently rule and section IV.C.5.d of this final to the aggregation group level. We account for relevant contraindications to rule. The proposed reliability proposed that the aggregation group for transplant and that additional risk adjustment approach would create a Managing Clinicians, once aggregated to adjustment for these factors is not weighted average between the the group practice or solo practitioner necessary. individual ETC Participant’s home level, as applicable, would be all After considering public comments, dialysis rate and transplant rate and the Managing Clinicians within the HRR in we are finalizing our proposed home dialysis rate and transplant rate which the group practice is located (for provisions for risk adjusting the home among the ETC Participant’s aggregation group practices) or the Managing dialysis rate and the transplant rate, group (previously described), with the Clinician’s HRR (for solo practitioners). relative weights of the two components with modifications. Specifically, in For ESRD facilities, we proposed that based on the statistical reliability of the response to the methodological the individual unit would be the ESRD individual ETC Participant’s home concerns highlighted by commenters facility. We proposed to define a dialysis rate and transplant rate, as ‘‘Subsidiary ESRD facility’’ as an ESRD regarding our proposed methodology for applicable. For example, if an ETC risk adjusting the home dialysis rate and facility owned in whole or in part by Participant’s home dialysis rate has high another legal entity. We proposed this subsequent analysis conducted by CMS, statistical reliability, then the ETC we are finalizing the home dialysis rate definition in recognition of the structure Participant’s individual home dialysis of the dialysis market, as described in calculation without a risk adjustment rate would contribute a large portion of this rule. We proposed that the methodology. CMS may add a risk the ETC Participant’s reliability- aggregation group for Subsidiary ESRD adjustment methodology to the home adjusted home dialysis rate and the facilities would be all ESRD facilities dialysis rate calculation, taking into aggregation group’s home dialysis rate located within the ESRD facility’s HRR account the comments received and any would contribute a small portion of the owned in whole or in part by the same additional feedback received from the ETC Participant’s reliability-adjusted company, and that ESRD facilities that public, in future rulemaking. We are home dialysis rate. We currently employ are not Subsidiary ESRD facilities finalizing in our regulation at this technique in a variety of settings, would be in an aggregation group with § 512.365(d) that the transplant waitlist including the measures used in creating all other ESRD facilities located within rate portion of the transplant rate will be hospital ratings for Hospital Compare. the same HRR (with the exception of risk adjusted based on beneficiary age We explained in the proposed rule that those ESRD facilities that are Subsidiary with separate risk coefficients for the the advantage of using this approach is ESRD facilities). following age categories of beneficiaries, that we could use one method to We sought input on our proposal to with age computed on the last day of produce comparable performance rates use reliability adjustments to address each month of the MY: 18 to 55; 56 to for ESRD facilities and Managing reliability issues related to small 70; and 71 to 74. We are also finalizing Clinicians across the size spectrum. We numbers, as well as on our proposed in our regulation at § 512.365(d) that the also noted that the disadvantage of aggregation groups for conducting the transplant waitlist rate portion of the using this approach is that reliability reliability adjustment for ESRD facilities adjusted performance rankings do not and Managing Clinicians that are ETC transplant rate will be adjusted to necessarily reflect absolute or observed Participants. account for the relative percentage of performance, and may be difficult to In the proposed rule, we the population of beneficiaries interpret directly. We stated that we acknowledged that for some segments of attributed to the ETC Participant in each believed this approach balanced the the dialysis market, companies age category relative to the national age need for individualized performance operating ESRD facilities may operate distribution of beneficiaries not assessment and incentives with the specific ESRD facilities that focus on excluded from attribution. The living importance of reliably assessing the home dialysis, which furnish home donor transplant rate portion of the performance of each ETC Participant. dialysis services to all patients receiving transplant rate will not be risk adjusted For Managing Clinicians, we home dialysis through that company in due to small sample sizes. proposed that the performance on these a given area. Therefore, assessing home

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dialysis rates at the individual ESRD Clinicians in a group practice at the TIN the aggregation group level, rather than facility level may not accurately reflect level. We also received comments at the facility level. However, as access to home dialysis for beneficiaries recommending that performance for a proposed, the aggregation group for a receiving care from a specific company Managing Clinician should be assessed Subsidiary ESRD facility will include in the area. In the proposed rule, we only based on the performance of other only those ESRD facilities owned in stated that we believed that the Managing Clinicians with whom the whole or in part by the same company reliability adjustment approach would Managing Clinician shares a business located in the same HRR. Based off of help to address this concern, because relationship. our analyses, CMS found rare instances the construction of the reliability Response: We appreciate the of typographical errors for facility adjustment for Subsidiary ESRD commenters’ support and are finalizing information in PECOS. We will address facilities would aggregate to the our proposal to assess the performance these inconsistencies by identifying company level within a given HRR and of Managing Clinicians in a group those ESRD facilities owned in whole or thus incorporate this dynamic. In the practice at the TIN level and to assess in part by the same company using the proposed rule, we considered using a the performance of Managing Clinicians Chain TIN and Chain Name from single aggregated home dialysis rate for who are not in a group practice, that is, PECOS with adjustments made for any all ESRD facilities owned in whole or in solo practitioners at the NPI level. mismatches arising from typographical part by the same company within a However, we no longer plan to further errors in those fields in PECOS using given HRR to account for this market aggregate performance for Managing CrownWEB and other CMS data dynamic. However, in the proposed rule Clinicians up to the HRR level, as sources. we stated that producing individual proposed. Based on comments received, While we understand the ESRD facility rates and reliability we recognize that it is most appropriate commenters’ concerns that dialysis adjusting individual ESRD facility to aggregate performance for Managing companies may operate across multiple scores would be necessary to incentivize Clinicians only for Managing Clinicians HRRs, as described in sections ESRD facilities within the same practicing under a common group IV.C.5.3.b and IV.C.5.3.c.(1) of this final company in the same HRR to provide practice (as identified by a TIN), and rule, we believe HRRs are the best the same level of care to all of their that the performance of solo practitioner representation of patterns of care and, attributed beneficiaries. Managing Clinicians should not be unlike other geographic units of The following is a summary of the aggregated with that of any other selection considered in the proposed comments received on the proposed Managing Clinicians. Specifically, we rule, also include rural areas. reliability adjustment and aggregation do not believe the Managing Clinician Additionally, CMS does not have methodologies and our responses. should be held accountable for the sufficient information regarding the Comment: We received comments performance of Managing Clinicians in location of home dialysis facilities that our proposed reliability adjustment unaffiliated practices at the HRR level relative to other Subsidiary ESRD lacked transparency and was difficult to because of their lack of business facilities of the same dialysis companies understand. Commenters noted that relationships. in order to make informed aggregation there was not sufficient detail for them Comment: We received multiple decisions on that basis (also, these to assess the potential impacts of the comments objecting to our proposed arrangements are likely subject to proposed policy. aggregation methodology for ESRD change). Moreover, tailoring ESRD Response: We appreciate the feedback facilities, pointing out that dialysis facility aggregation based on each from commenters about the proposed companies often concentrate their home dialysis company’s corporate structure reliability adjustment. In response to dialysis patients at certain regional would be difficult to administer for these comments, we are not finalizing centers that solely focus on home CMS and could be subject to gaming by the proposed reliability adjustment dialysis. Additionally, we received the dialysis companies. policy. CMS no longer believes that the comments that requiring a home Comment: We received multiple reliability adjustment is necessary for dialysis program to be built at each comments in support of our proposal Managing Clinicians or for ESRD ESRD facility would be duplicative and that the aggregation group for facilities in light of the changes to the would not necessarily improve patient Subsidiary ESRD Facilities should be all aggregation policies described in this care. We also received comments that ESRD facilities located within the ESRD section of this final rule, under which ESRD Beneficiaries who receive facility’s HRR owned in whole or in part the performance of Managing Clinicians treatment from ESRD facilities that are by the same company. Additionally, we will be assessed at the practice level, if ETC Participants may receive home received comments suggesting that all applicable, and the performance of dialysis services from a home dialysis ESRD facilities located in the same HRR ESRD facilities will be assessed at the facility that is owned in whole or in part should receive a single combined score aggregation group level instead of at the by the same dialysis company, but that regardless of their ownership status. individual facility level. In addition, as is not necessarily within the same HRR Response: We appreciate comments discussed in section IV.C.5.f of this final as the ESRD facility. supporting our proposal that the rule, we have increased the low-volume Response: Based on comments aggregation group for Subsidiary ESRD threshold relative to the low-volume received from the public, we believe facilities would be all ESRD facilities threshold outlined in the proposed rule, that the nature of the dialysis market owned in whole or in part by the same which will remove greater numbers of means that assessing home dialysis rates company within an HRR. We believe the smallest ETC Participants from the at the individual ESRD facility level this is a fair approach that allows the application of the PPA, further may not accurately reflect access to performance for ESRD facilities to be increasing the statistical reliability of home dialysis through that company in assessed based solely on the the rates used as part of the PPA a given area. Our intent is to ensure that performance of facilities that are owned calculation. home dialysis is available to every ESRD in whole or in part by the same Comment: We received comments in Beneficiary, not necessarily at every company, rather than facilities that may support of our proposal to aggregate individual ESRD facility. In order to be owned by different companies. performance on the home dialysis rate better align with market dynamics, we Additionally, we see the benefits of and transplant rate for Managing will assess ESRD facility performance at grouping ESRD facilities within the

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same HRR, as the boundaries of the correctly identify ESRD facilities. alternatively considered using national HRRs reflect referral patterns and Subsequent CMS analyses also found performance rates to construct these because an ESRD facility is more likely rare instances of typographical errors for benchmarks. However, in order to to refer patients for home dialysis and facility information in PECOS. In prevent the impact of the model other services to an ESRD facility response, we are modifying our policy intervention altering benchmarks for located in the same geographic area than in this final rule such that Subsidiary subsequent MYs, we decided against to an ESRD facility located farther away. ESRD facilities will be identified using this alternative in the proposed rule. We Comment: We received a comment the Chain TIN and Chain Name from proposed to calculate the home dialysis recommending that CMS create a virtual PECOS and that CMS will use other rate and transplant rate benchmarks for group for small or low-volume ESRD CMS data sources, including ESRD facilities and Managing Clinicians facilities with a smaller presence in the CrownWEB, to identify and correct any located in Comparison Geographic specific HRR to aggregate performance. mismatches arising from typographical Areas during the Benchmark Year using Response: We appreciate this errors in those fields in PECOS. CMS the same methodologies that we use to recommendation but do not believe that may notify ESRD facilities of their status calculate the home dialysis rate and creating a virtual group will be as a Subsidiary ESRD Facility and, if transplant rate for ESRD facilities and necessary to improve the reliability of applicable, the other Subsidiary ESRD Managing Clinicians located in Selected the home dialysis rates and transplant Facilities with which CMS has Geographic Areas during the MYs. We rates for low-volume ESRD facilities. In identified a common ownership stated our intent to establish the addition to the operational complexities relationship during the MY to allow benchmarking methodology for future that implementing a virtual group ESRD facilities the opportunity to MYs through subsequent rulemaking. would present for CMS, we believe that confirm and provide feedback before As stated in the proposed rule, our the increased low-volume threshold CMS calculates the PPA for that MY. We intent in future MYs is to increase described in section IV.C.5.f. of this are also modifying our aggregation achievement benchmarks among ETC final rule will help to improve the approach for ESRD facilities that are not Participants above the rates observed in statistical reliability of the home Subsidiary ESRD facilities, such that Comparison Geographic Areas. By MY9 dialysis rates and transplant rates for these ESRD facilities will not be and MY10, in order to receive the small ESRD facilities, while ensuring a aggregated with other facilities located maximum achievement score, as noted viable model test. within the HRR in which the facility is After considering public comments, in the proposed rule, we were located or otherwise. We are also considering that an ETC Participant we are finalizing our proposed finalizing the Taxpayer Identification provisions for reliability adjustment and would have to have a combined home Number (TIN), National Provider dialysis rate and transplant rate aggregation of the home dialysis rate Identifier (NPI), and Subsidiary ESRD and transplant rate, with modifications. equivalent to 80 percent of attributed facility definitions, as proposed, in our beneficiaries dialyzing at home and/or Specifically, we are removing the regulation at § 512.310. reliability adjustment for both ESRD having received a transplant. We sought facilities and Managing Clinicians. d. Benchmarking and Scoring public comment on our intent to Additionally, we are codifying in our We proposed calculating two types of increase achievement benchmarks over regulation at § 512.365(e)(2) that a benchmarks for rates of home dialysis the duration of the Model. Managing Clinician’s performance on and transplants against which to assess The second set of benchmarks would the home dialysis rate and transplant ETC Participant performance in MY1 be used in calculating an improvement rate will be aggregated to the Managing and MY2 (both of which would begin in score for the ETC Participant on both Clinician’s aggregation group, which is CY 2020). Under our proposal, risk- the home dialysis rate and the identified at the TIN level for Managing adjusted and reliability-adjusted ETC transplant rate. This set of benchmarks Clinicians in a group practice and at the Participant performance for the home would be constructed based on individual NPI level for Managing dialysis rate and the transplant rate historical rates of home dialysis and Clinicians who are solo practitioners. would be assessed against these transplants by the ETC Participant We are not finalizing our proposal to benchmarks on both achievement and during the Benchmark Year. We further aggregate Managing Clinician improvement at the ETC Participant proposed to calculate the improvement performance with all other Managing level. score by comparing MY performance on Clinicians located within the HRR. The first set of benchmarks would be the home dialysis rate and transplant Additionally, in § 512.365(e)(1), we are used in calculating an achievement rate against past ETC Participant finalizing our proposal that ESRD score for the ETC Participant on both performance to acknowledge efforts facilities’ home dialysis rate and the home dialysis rate and the made in practice transformation to transplant rate will be aggregated to the transplant rate. This set of benchmarks improve rates of home dialysis and ESRD facility’s aggregation group, would be constructed based on transplants. However, we proposed that which is defined as all ESRD facilities historical rates of home dialysis and an ETC Participant could not attain the owned in whole or in part by the same transplants in Comparison Geographic highest scoring level through company within an HRR for a Areas. We proposed constructing the improvement scoring. Specifically, Subsidiary ESRD facility. As discussed benchmarks using 12 months of data, while an ETC Participant could earn an previously in this final rule rule, CMS beginning 18 months before the start of achievement score of up to 2 points for is finalizing its proposal to use PECOS the MY and ending 6 months before the the transplant rate and the home to verify the correct zip code of the start of the MY, to allow time for claims dialysis rate, the maximum possible ESRD facility location for purposes of run-out and calculation. We proposed to improvement score is 1.5 points for each selecting ESRD facilities for refer to this period of time as the of the rates. We explained that this participation in the Model. However, ‘‘benchmark year.’’ We proposed using policy would be consistent with other CMS received public comments data from ESRD facilities and Managing CMS programs and initiatives regarding our proposed aggregation Clinicians located in Comparison employing similar improvement scoring policy suggesting that CMS use Geographic Areas to construct these methodologies, including the CEC resources in addition to PECOS to benchmarks. In the proposed rule, we Model.

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In the proposed rule, we considered we believe that including improvement performance for the first two MYs. Table not including improvement scoring for scoring for the first two MYs is 13 details the proposed scoring the first two MYs, as this would mean appropriate, as it acknowledges methodology for assessment of MY1 and assessing improvement in the MY performance improvement gains while MY2 achievement scores and against ETC Participant performance participating in the ETC Model. We improvement scores on the home before the ETC Model would begin. sought input on the use of improvement dialysis rate and transplant rate. However, as noted in the proposed rule, scoring in assessing ETC Participant

Under our proposal, the ETC renal replacement therapy modalities. Some of these commenters stated that Participant would receive the higher of However, we recognized that transplant this comparative approach serves only the achievement score or improvement rates may be more difficult for ETC as a way for CMS to ensure Model score for the home dialysis rate and the Participants to improve than home savings, as some ETC Participants’ higher of the achievement score or dialysis rates, due to the limited supply performance would fall below the improvement score for the transplant of organs and the number of other achievement benchmarks, resulting in a rate, which would be combined to providers and suppliers that are part of negative payment adjustment. A produce the ETC Participant’s Modality the transplant process but are not commenter opined that the percentile Performance Score (MPS). We proposed included as participants in the ETC based achievement scoring approach the following formula for determining Model. For this reason, we proposed would not be operational at the ESRD the MPS: that the home dialysis rate component facility level because, based on the MPS = 2 × (The higher of the home take a greater weight than the transplant commenter’s analysis, there would be dialysis rate achievement or rate component of the MPS. no differentiation in home dialysis rates improvement score) + (The higher The following is a summary of the for the three lowest scoring groups. This of the transplant rate achievement comments received on the proposed comment was cited by several other or improvement score) benchmarking and scoring methodology commenters. We proposed that the home dialysis and our responses. Response: We disagree that using a rate score would constitute two thirds of Comment: Several commenters comparative approach for calculating the MPS, and that the transplant rate opposed our proposal to use a achievement benchmarks, percentile- score would constitute one third of the comparative or percentile based based or otherwise, does not reflect ETC MPS. In the proposed rule, we methodology for purposes of calculating Participant performance or the care considered making the home dialysis the achievement benchmarks. being provided. On the contrary, rate score and the transplant rate score According to some of these commenters, comparative benchmarks reflect the equal components of the MPS, to this comparative approach would not performance of the ETC Participant emphasize the importance of both home accurately reflect ETC Participant relative to their peers. We also disagree dialysis and transplants as alternative performance or the care being provided. that a comparative approach serves only

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as a way to ensure Model savings for the national nature of the dialysis improved performance in Selected two reasons. First, because achievement market. Geographic Areas. We believe that this benchmarks are constructed based on Comment: Several commenters approach would mitigate concerns that performance of those not selected for opposed the construction of dialysis organizations operating ESRD participation in the Model, it is possible achievement benchmarks based on rates facilities in both Selected Geographic that many ETC Participants will meet or in Comparison Geographic Areas, for Areas and Comparison Geographic exceed the level of performance the following reasons. First, several of Areas may exert influence on necessary to not receive a negative these commenters pointed out that, due achievement benchmarks by altering the adjustment through achievement to the national nature of the dialysis provision of home dialysis or transplant scoring alone. Second, the use of market, dialysis companies operating services in Comparison Geographic improvement scoring alongside nationally may implement practices that Areas. As described in section IV.C.10 achievement scoring means that ETC improve rates nationwide, not just in of this final rule, we intend to monitor Participants can avoid negative payment Selected Geographic Areas, so for unintended consequences, such as adjustments through improvement achievement benchmarks based on rates those enumerated by commenters, and alone, regardless of their performance in in Comparison Geographic Areas would to make adjustments to the Model relation to the achievement benchmarks. not remain constant over time. Second, through subsequent rulemaking should We disagree with the commenter’s one of these commenters stated that such unintended consequences arise. analysis suggesting that there would be basing achievement benchmarks on We appreciate the suggestion that we no differentiation between the lowest Comparison Geographic Areas when check for balance on certain covariates three benchmark groups if home dialysis organizations have ESRD that may impact rates of home dialysis dialysis rates were assessed at the ESRD facilities in both Selected Geographic and transplantation between Selected facility level based on our analyses of Areas and Comparison Geographic Geographic Areas and Comparison claims data conducted in the Areas creates an incentive for those Geographic Areas. However, we believe development of this final rule. dialysis organizations to lower rates of that our policy of establishing Selected Specifically, our analyses indicated that home dialysis and transplants in Geographic Areas by stratified after the application of the aggregation Comparison Geographic Areas to randomization of a sufficiently large group methodology to the performance improve the performance of their number of HRRs adequately accounts of ESRD facilities located in Selected locations that are ETC Participants. for underlying variation. Geographic Areas, there is A commenter recommended that CMS Comment: A commenter differentiation in the home dialysis rates monitor the rates of home dialysis and recommended calculating achievement among ESRD facilities at or below the transplants between Selected benchmarks separately for each Selected 50th percentile of benchmark rates for Geographic Areas and Comparison Geographic Area, or including a Comparison Geographic Areas, which Geographic Areas to determine whether geographic adjustment factor in the corresponds with the lowest three the Model is resulting in unintended achievement benchmark calculation, to groups used for purposes of assessing an consequences—including market account for regional variation in rates. A ESRD facility’s achievement score. We consolidation, manipulation of commenter recommended that CMS also note that, as proposed, we will achievement benchmarks, declining create achievement benchmarks for each calculate the benchmarks for the home rates of home dialysis or transplant in Selected Geographic Area for the dialysis rate and the transplant rate for Comparison Geographic Areas, or transplant rate, to account for historical ESRD facilities and Managing Clinicians adverse patient outcomes—due to the variation in the availability of organs located in Comparison Geographic distribution of LDOs in both Selected and rates of transplantation across the Areas during the Benchmark Year using Geographic Areas and Comparison country. Another commenter opined the same methodologies that we use to Geographic Areas. A commenter that achievement benchmarks for home calculate the home dialysis rate and recommended that the use of dialysis rates should not be the same transplant rates for ESRD facilities and Comparison Geographic Areas for nationally because there may be Managing Clinicians located in Selected achievement benchmarks be contingent underlying factors that vary across the Geographic Areas during the MYs. on achieving statistical balance on country that impact patient preference Accordingly, we will be aggregating certain covariates that may impact rates for home dialysis. A commenter Subsidiary ESRD facilities with all of home dialysis and transplantation opposed constructing benchmarks ESRD facilities owned in whole or in between Selected Geographic Areas and specific to each Selected Geographic part by the same dialysis organization Comparison Geographic Areas, to avoid Area, opining that this would be overly located in the same HRR when making inappropriate comparisons complicated. constructing the benchmarks, as between the two. Response: We appreciate the described in section IV.C.5.c.(4) of this Response: We anticipate that rates for commenters’ recommendations that we final rule. home dialysis, transplant waitlisting, calculate more regionally specific Comment: A commenter supported and living donor transplants will change achievement benchmarks. However, we our proposal to use Comparison in Selected Geographic Areas, and may agree with the commenter that stated Geographic Areas to create achievement change in Comparison Geographic that calculating achievement benchmarks, and concurred with CMS’s Areas, over the course of the Model. As benchmarks specific to each Selected decision not to use national stated in the proposed rule and in Geographic Area would be overly performance rates to construct these section IV.C.5.d of this final rule, we complicated, and we also believe that benchmarks because the model design intend to establish a different method this approach would perpetuate regional adequately controls for any spillover for establishing achievement differences in home dialysis and effects due to the national nature of the benchmarks for future years of the transplant rates that are not beneficial dialysis market. Model through subsequent rulemaking. for beneficiaries. Accordingly, we are Response: We appreciate the feedback We expect that this method would not finalizing our proposal to establish a and support from the commenter and be based solely based on rates in single achievement benchmark for each agree that the model design adequately Comparison Geographic Areas, and MY based on rates of home dialysis, controls for any spillover effects due to would be designed to incentivize transplant waitlisting, and living donor

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transplants in the Comparison Several commenters expressed concern more attainable level in consultation Geographic Areas. that CMS would adjust the with the kidney community. Comment: A commenter stated that benchmarking methodology for future Response: We appreciate this any changes to the organ allocation MYs to achieve Model savings rather feedback from the commenters and the system, such as those under than to accurately reflect ETC support for setting ambitious goals. consideration by the Organ Procurement Participant performance and incentivize While we did not codify these goals in and Transplant Network (OPTN), may ETC Participants to achieve the Model’s the final rule, we anticipate that we will make achievement benchmarks for goals of improving or maintaining codify more ambitious achievement transplant rates based on historical quality and reducing costs by increasing goals in subsequent rulemaking. We performance in Comparison Geographic rates of home dialysis and appreciate the commenter’s concern Areas an inappropriate comparison for transplantation. Several commenters about setting the achievement goal at 80 purposes of assessing current transplant recommended that CMS maintain the percent, as well as the suggestion of rates due to intervening changes in benchmarking methodology proposed using 50 percent as the goal. We will organ availability by region. for MY1 and MY2 for the duration of the take these comments into consideration Response: We appreciate the feedback Model. Several commenters stated that as we consider any future changes to the from this commenter. As described in CMS should establish the benchmarking achievement benchmark methodology. section IV.C.5.c.(2) of this rule, we are methodology for all MYs before the Comment: Multiple commenters modifying the transplant rate used to Model begins to give ETC Participants expressed opposition to the goal of assess ETC Participant performance the opportunity to plan accordingly. having 80 percent of attributed such that it no longer includes deceased Response: We appreciate the beneficiaries dialyzing at home and/or donor transplants. As such, we do not commenters’ concerns about the need receiving a kidney or kidney-pancreas believe that changes to the organ for transparency and for ETC transplant. Commenters stated that there allocation system will impact Participants to be successful in the is not empirical or clinical evidence that performance benchmark construction, Model. However, we believe that our the 80 percent goal is achievable or as these changes do not directly impact approach would be transparent, as any desirable in the U.S., or within the transplant waitlisting or living donation. changes to the achievement timeframe of the Model. Several Additionally, as discussed in the benchmarking methodology for commenters stated that this goal would proposed rule and previously in this subsequent MYs would be established lead to inappropriate pressure on final rule, we intend to make changes to through notice and comment the achievement benchmarking beneficiaries to select home dialysis, rulemaking. While we do not intend to approach for future MYs through when home dialysis may not be their maintain the benchmarking subsequent rulemaking, including to set preferred form of renal replacement benchmarks that are not dependent on methodology we are finalizing now therapy. A commenter stated that this historical rates of transplants in through the duration of the Model, as goal would ensure that ETC Participants Comparison Geographic Areas. We will we expect that this methodology would are not successful in future MYs. A take this comment into consideration as not provide a sufficient incentive for commenter pointed out that the we consider any such future changes, to ETC Participants to raise home dialysis Regulatory Impact Analysis for the ensure that any changes in the organ and transplant rates at a rate faster than proposed ETC Model projected a allocation system will not would occur absent the Model, we do conservative growth rate in home disproportionately impact the acknowledge that finalizing our dialysis and no growth in achievement benchmarks used in future proposal to apply this methodology only transplantation, which contradicts the MYs. for MY1 and MY2 would create some 80 percent goal. A commenter pointed Comment: A commenter uncertainty about the benchmarking out that without significant increases in recommended that CMS establish methodology for MYs immediately organ availability, it would not be achievement benchmarks that are not following MY2. For this reason, we are possible for ETC Participants to achieve based on Comparison Geographic Areas. specifying that we will continue to use increases in the transplant rate over the Response: We appreciate the input the achievement benchmarking duration of the Model necessary to from the commenter. We continue to methodology we proposed and are achieve the 80 percent goal. A believe that using Comparison finalizing for MY1 and MY2 for future commenter stated that CMS should raise Geographic Areas to establish MYs if subsequent rulemaking cannot achievement benchmarks over the achievement benchmarks for the initial be completed with sufficient notice in duration of the Model at a rate that is years of the Model is appropriate. advance of those MYs. reasonable in relation to historic However, we will consider this input Comment: Several commenters performance. about establishing achievement expressed support for setting ambitious Response: We clarify that, as benchmarks that are not based on goals for home dialysis and transplant described in the proposed rule, the 80 Comparison Geographic Areas if we rates, and stated that higher rates of percent goal would be the target for make changes to the achievement home dialysis and transplantation are receiving the highest payment benchmarking methodology for future achievable. A commenter who adjustment in the final MYs of the years of the Model through subsequent expressed such support recommended Model. However, any changes to the rulemaking. lowering our goal for future MYs from achievement benchmark methodologies Comment: Several commenters a combined home dialysis rate and for the later MYs of the Model would be opposed our stated intent to increase transplant rate equivalent to 80 percent made through subsequent rulemaking. achievement benchmarks for future MYs of attributed beneficiaries dialyzing at We appreciate this feedback from through subsequent rulemaking. Some home and/or having received a commenters about the feasibility of the commenters opined that this approach transplant to 50 percent, which they goal we are considering for MY9 and lacks transparency, unfairly penalizes suggested was still ambitious but more MY10 and will take these comments ETC Participants by changing the target attainable for ETC Participants. Another into consideration as we consider any over time, and undermines ETC commenter recommended that our goal future changes to the achievement Participant success in the Model. for future MYs should be reduced to a benchmark methodology.

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Comment: A commenter stated that inappropriate to limit ETC Participants’ We disagree that the goal of the Model CMS should propose all benchmarks ability to achieve the highest score should be to ensure that all appropriate through notice and comment based on improvement scoring, ESRD Beneficiaries receive transplants, rulemaking. A commenter suggested particularly because the proposed as the stated goal is to maintain or that the achievement benchmarks not be achievement benchmarks would not improve quality and reduce Medicare communicated to ETC Participants in account for regional variation in home expenditures through increased rates of advance of the MY to which they apply, dialysis rates and transplant rates. A home dialysis and transplants. As we in order to avoid a ‘‘performance floor’’ commenter pointed out that ETC stated in the proposed rule, we effect in which ETC Participants aim to Participants that improve significantly considered making the home dialysis meet only the minimum necessary on the home dialysis rate may rate score and the transplant rate score performance. nonetheless not receive an upward equal components of the MPS, to Response: We proposed the payment adjustment if their home emphasize the importance of both home achievement benchmark methodology dialysis rates are below the 50th dialysis and transplants as alternative for the initial MYs of the Model in the percentile achievement benchmark or renal replacement therapy modalities. proposed rule, which we are finalizing their transplant rates are not above the However, we recognized that transplant with modification in this final rule, and 50th percentile achievement rates may be more difficult for ETC will establish any changes to these benchmark. Several commenters Participants to improve than home benchmarking methodologies through recommended changing the dialysis rates, due to the limited supply notice and comment rulemaking. improvement scoring methodology to of organs and the number of other However, in order to provide provide greater recognition of providers and suppliers that are part of achievement benchmarks for each MY improvement over time. In particular, the transplant process. The transplant that reflect changing rates of home commenters recommended that portion of the MPS is now based on dialysis and transplant in a timely improvement greater than 10 percent be performance on the transplant rate manner, we do not intend to propose awarded two points. calculated as the sum of the transplant the benchmarks themselves through Response: We appreciate the feedback waitlist rate and the living donor rulemaking. Rather, we will use the from these commenters, and transplant rate, as described in sections methodologies finalized through acknowledge the importance of IV.C.5 and IV.C.5.c.(2) of this final rule, rulemaking to calculate the applicable incentivizing improvement over time. which addresses the commenter’s achievement benchmark in advance of However, as stated in the proposed rule concern that the transplant rate does not each MY. We do not believe that it and previously in this final rule, we accurately reflect ESRD facility would be fair to ETC Participants not to proposed not to award full points for performance due to factors outside of announce achievement benchmarks in improvement for consistency with other their control, given that the main advance of the period to which those CMS programs and initiatives limiting factor is the availability of benchmarks apply and therefore decline employing similar improvement scoring deceased donor organs. Despite this to adopt the commenter’s suggestion methodologies. The ETC Model is change to the transplant portion of the that benchmarks should not be designed to focus on outcomes. While MPS, we continue to believe that the communicated to participants in improvement is laudable and deserving transplant waitlist and living donor advance of the MY. of recognition through improvement processes involve similar challenges for Comment: A commenter stated that scoring, awarding maximum points for ETC Participants as the transplant CMS should consider geographic and improvement scoring is inconsistent process overall, including the number of socioeconomic factors that impact home with the Model’s focus. As such, we other providers and suppliers that are dialysis and transplant rates when will award full points for achievement part of the transplant process. Therefore, establishing achievement benchmarks. scoring only. we continue to believe that it is Response: We appreciate the feedback Comment: A commenter raised appropriate that the home dialysis rate from the commenter, and recognize that concerns that the proposed construction constitute two thirds of the MPS and there is variation in rates of home of the MPS places greater weight on that the transplant rate constitute one dialysis and transplantation by region home dialysis rates, and therefore gives third of the MPS. and by socioeconomic status. Were we ETC Participants a greater incentive to Comment: Several commenters to make adjustments to account for improve rates of home dialysis than recommended that CMS use the these factors, we would do so in the risk transplantation rates, when the goal of benchmarking and scoring methodology adjustment methodology for the home the Model should be to ensure that all used by the ESRD QIP for purposes of dialysis rate and transplant rate, rather appropriate ESRD Beneficiaries receive the MPS calculation. These commenters than by adjusting the achievement transplants. A commenter stated that the stated that ESRD facilities are familiar benchmarks for each ETC Participant proposed approach for weighting home with these methodologies, and that such that we would be able to provide dialysis rates and transplant rates in using them in this Model would make one set of general achievement calculating the MPS penalizes small the two initiatives more consistent with benchmarks rather than achievement ESRD facilities that cannot develop and each other. A commenter recommended benchmarks specific to particular maintain home dialysis programs. A that CMS adapt the quality regions or populations. In section commenter stated that, given how little benchmarking and scoring methodology IV.C.5.c.(3) of this final rule, we discuss control ESRD facilities have over who used by the CEC Model for purposes of the risk adjustment methodology for the receives a kidney transplant, the the MPS calculation under the Model. ETC Model. inclusion of the transplant rate as one Response: While we acknowledge that Comment: Several commenters third of the MPS does not accurately ESRD facilities are familiar with the supported the proposed inclusion of reflect dialysis provider efforts or ESRD QIP benchmarking and scoring improvement scoring, but opposed our performance. methodologies, we do not believe these proposal that ETC Participants cannot Response: We appreciate the feedback methodologies are well suited to this obtain full points on the basis of from commenters on the relative Model. The ETC Model is designed to improvement scoring. Several weights of the home dialysis portion test the ability of the Model’s payment commenters stated that it would be and the transplant portion of the MPS. adjustments to improve or maintain

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quality while reducing costs through change to capitalize the term negative PPA to ESRD facility home increased rates of home dialysis and ‘‘Benchmark Year’’ in the final rule. dialysis treatments, even if an ESRD facility earns a negative PPA. The same transplantation. The benchmarking e. Performance Payment Adjustments methodology for the ETC Model must be commenter recommended that CMS designed with this goal in mind. While We proposed that CMS would make remove negative payment adjustments the ESRD QIP performance standard upward and downward adjustments to from the Model altogether, and instead setting methodology substitutes payments for claims for dialysis and create upside financial incentives for performance standards from previous dialysis-related services, described in the more than 50 percent of ESRD years if those performance standards are the proposed rule and in section facilities that currently do not offer IV.C.5.e of this final rule, submitted by higher than the performance standards home dialysis. Another commenter each ETC Participant with a claim that would otherwise apply, it does not recommended that CMS apply any through date during the applicable PPA ensure escalating performance standards negative PPA amount only to in-center period based on the ETC Participant’s over time. Rather, the ESRD QIP treatment payments, and not to home PPA. We proposed that the magnitude dialysis treatment or home training performance standard setting of the potential positive and negative methodology ensures that performance payments. payment adjustments would increase Response: We thank the commenters standards do not decrease over time. As over the PPA Periods of the ETC Model. for their feedback. CMS believes that stated in the proposed rule and The magnitude of the PPAs were negatively adjusting home dialysis elsewhere in this final rule, we may designed to be comparable to the MIPS claims is appropriate when an ETC consider increasing the achievement payment adjustment factors for MIPS Participant earns a negative PPA, just as benchmarks used under this Model for eligible clinicians, as described in the CMS believes it is appropriate to future MYs. Any such changes would be proposed rule and in sections positively adjust home dialysis claims made through future rulemaking. While IV.C.5.e.(1) and IV.C.5.e.(2) of this final when an ETC Participant earns a we may consider increasing the rule. Specifically, the PPAs were positive PPA. As discussed in the performance standards, we do not designed to be substantial enough to proposed rule, the PPA is designed to be intend to adopt a policy to specifically incentivize appropriate behavior substantial enough to provide an prevent that achievement benchmarks without overly harming ETC incentive robust enough to spur positive do not decrease. Additionally, Managing Participants through reduced payments. behavior change without overly harming Clinicians are not subject to the ESRD The payment adjustments proposed for ETC Participants through reduced QIP, and therefore may not be familiar the ETC Model would start at the same payments. with the ESRD QIP methodology. We 5 percent level in 2020 as the MIPS CMS disagrees that eliminating the believe it is important to maintain payment adjustment at 42 CFR negative payment adjustment or consistency within the ETC Model for 414.1405(c). As discussed in the subjecting ESRD facilities that currently the two types of ETC Participants— proposed rule, the PPAs proposed for do not furnish home dialysis to upside namely ESRD facilities and Managing the ETC Model were also designed to financial incentives only would be Clinicians. We point out that we are increase over time and to be appropriate given the goals of the using the same benchmarking and asymmetrical—with larger negative Model. Specifically, CMS intends for scoring methodology as the one used by adjustments than positive adjustments— the ETC Model to both encourage ESRD the CEC Model for scoring quality in order to create stronger financial facilities who do not currently offer performance. incentives. home dialysis to establish home dialysis As we noted in the proposed rule, programs, and for ESRD facilities who After considering public comments, CMS believes that downside risk is a currently do offer home dialysis to we are finalizing our proposed critical component of this Model in increase the provision of these services. provisions on the benchmarking and order to create strong incentives for The proposed PPA accomplishes this scoring methodology in our regulation behavioral change among ETC goal by holding all ESRD facilities at § 512.370(a), with modification. Participants. We proposed that the accountable for their rates of home Specifically, while we proposed to negative adjustments would be greater dialysis, which CMS believes provides a apply our proposed achievement for ESRD facilities than for Managing powerful incentive to establish benchmark policy only for MY1 and Clinicians, in recognition of the ESRD successful home dialysis programs. We MY2, in response to public comments, facilities’ larger size and ability to bear further believe that imposing the HDPA we will apply the achievement downside financial risk relative to only, or a similar upside financial benchmarking methodology we are individual clinicians. As noted in the incentive, to ESRD facilities that do not finalizing in this final rule for MY1 proposed rule, we believe that the currently provide home dialysis would (January 1, 2021 to December 31, 2021) exclusion of ESRD facilities that fall not provide a strong enough incentive to and MY2 (July 1, 2021 to June 30, 2022), below the low-volume threshold create the behavior change CMS seeks in and for subsequent MYs, if not first described in the proposed rule and in implementing this Model. modified by subsequent rulemaking. We section IV.C.5.f.(1) of this final rule In addition, CMS believes that are also finalizing our proposal to define would ensure that only those ESRD negatively adjusting claims for in-center the ‘‘Benchmark Year’’ as the 12-month facilities with the financial capacity to dialysis only would not produce a period of data that begins 18 months bear downside risk would be subject to sufficient incentive to encourage the prior to the start of a given MY from application of the Facility PPA. behavior change that the Model is which data is used to construct The following is a summary of the designed to produce. benchmarks against which to score an comments received on the proposed Comment: Many commenters ETC Participants achievement and PPA and our responses. expressed concerns about our proposal improvement on the home dialysis rate Comment: A commenter expressed to apply significant downside risk for and transplant rate for the purpose of support for our proposal to subject MY1, reasoning that ETC Participants calculating the ETC Participant’s MPS Managing Clinicians to less downside would not have sufficient time to build in our regulation at § 512.310. In risk than ESRD facilities. A commenter out a clinical model and the necessary addition, we are making a technical recommended that CMS not apply a infrastructure to establish or build upon

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a home dialysis program before being PPA and HDPA schedule best of care for beneficiaries, and/or subject to downside financial risk for accomplishes that goal. beneficiaries who receive in-center their rates of home dialysis. Several Regarding the comments that CMS dialysis being required to travel longer commenters recommended that CMS can learn from the comments submitted distances to receive treatment. Some of delay implementing the PPA for one in response to the request for these commenters articulated specific year. Other commenters recommended information in the CY 2020 Hospital reasons why they expected the PPA that CMS delay implementing the PPA Outpatient Prospective Payment System would result in such unintended for two years. Those commenters proposed rule (84 FR 39398) related to consequences, such as smaller entities recommending that the PPA be delayed OPOs and transplant centers (84 FR needing to expend substantial capital to asserted that such a change would allow 39597), CMS will not change the PPA prepare for the Model, hire nephrology more time for ETC Participants to policy in this final rule based on those nurses, build or expand training space, receive positive adjustments from the comments, but those comments may and increase administrative capabilities. HDPA and ensure that ETC Participants inform future policy changes under the A few of these commenters expressed Model. would have access to performance data concern that the PPA could lead to Comment: A commenter that facility closures for small, independent, before being subjected to downside risk. supported a delay in implementing Other commenters asserted that and/or rural ESRD facilities, which the downside financial risk under the commenters suggested are less able than delaying the implementation of the PPA Model recommended that CMS would better allow ETC Participants to LDOs to absorb financial losses that may implement a transplant bonus to result from the application of the PPA. build infrastructure, gather necessary incentivize ETC Participants and other resources and equipment, and spread A commenter expressed concern that stakeholders to implement new the PPA would destabilize the Medicare out the potential for financial losses, programs and processes needed to without risking closure of ESRD ESRD benefit, which the commenter support transplant rate growth. asserted is already underfunded. Some facilities and possibly limiting patients’ Response: CMS disagrees with the commenters expressed concern that access to care, particularly in urban and recommendation to implement a potential for downside risk due to the rural areas where ESRD facility margins transplant bonus in the ETC Model. application of the PPA would are low and housing instability rates are CMS believes that the PPA sufficiently incentivize ETC Participants to push high. Some commenters recommended rewards high performing ETC ESRD Beneficiaries to home dialysis that CMS delay implementing downside Participants for successfully increasing modalities even when it is not clinically risk related to transplant until CMS can their transplant waitlisting rate and or socially appropriate. One such learn from the many comments living donor transplant rate, which may commenter identified housing submitted in response to the request for ultimately result in higher rates of insecurity and social isolation as social kidney transplants. Further, ETC information in the CY 2020 Hospital factors that may make a beneficiary ill- Participants may simultaneously Outpatient Prospective Payment System suited for home dialysis, and proposed rule (84 FR 39398) related to participate in the KCC Model, which includes a kidney transplant bonus recommended that CMS consider social OPOs and transplant centers (84 FR and clinical factors in determining the 39597). payment. It is likely that at least some ETC Participants will also participate in magnitude of an ESRD facility’s PPA. Response: CMS believes that applying the KCC Model, such that implementing Response: CMS disagrees with the downside financial risk via the PPA, as a kidney transplant bonus payment comments expressing concern that the proposed, is more appropriate than the under the ETC Model would present the PPA will cause ESRD facility closure, alternatives suggested by the risk of ‘‘double paying’’ ETC reduce patient choice, reduce quality of commenters. CMS believes it is Participants for successful transplants. care, and/or force ESRD Beneficiaries to important to apply downside risk at the In addition, using distinct payment travel longer distances to receive beginning of the Model to create strong methodologies in the KCC Model, which treatment. The Model aims to increase incentives for behavior change. As has a kidney transplant bonus payment, choice by addressing a notable lack of described in the proposed rule and and the ETC Model, which does not, home dialysis provision, and thus earlier in this final rule, CMS carefully will better allow CMS to determine the increase ESRD Beneficiary choice considered the timeline for applying the effectiveness of a transplant bonus in among renal replacement modalities HDPA and the PPA, and CMS continues incentivizing support and care for and, in many cases, eliminate the to believe that the proposed schedules beneficiaries through the kidney commutes ESRD Beneficiaries must of each optimally balances the timing transplant process, including after currently make to receive treatment in and magnitude of the process-based transplantation, as CMS will be able to center. CMS also disagrees with incentive, the HDPA, with the outcome- test the effects of different payment comments expressing concern that the based incentive, the PPA. Further, the methodologies under the two models as PPA will especially harm small, PPA starts at its lowest point while the well as the effects of overlapping independent, and/or rural ESRD HDPA starts at its highest point, which incentives. facilities, as opposed to LDOs, since the gives ETC Participants the time to build Comment: A commenter expressed PPA uses percentages rather than out their clinical models and necessary support for the ETC Model’s two-sided absolute figures in making its infrastructure to establish or build upon risk structure. Another commenter adjustments. While LDOs are larger and, their home dialysis programs. While expressed general support for both the as a result, may be better able to absorb CMS understands the commenters’ view Clinician PPA and Facility PPA. financial losses, an LDO and a non-LDO that delays in the application of the PPA Response: We appreciate the feedback who perform equally poorly will face would allow ETC Participants more and support from the commenters. proportionate reductions in Medicare time to take all steps necessary to Comment: Several commenters reimbursement under the Model, and increase provision of home dialysis, expressed concern that the PPA could vice versa. Moreover, even if the CMS intends for the ETC Model to have unintended consequences, proposed PPA would have the incent behavior change, and CMS including ESRD facility closure, unintended consequences cited by continues to believe that the proposed reduced patient choice, reduced quality commenters, as discussed later in this

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final rule, CMS is finalizing a reduction home dialysis therapy may require recommended that CMS reduce the in the magnitude of the Clinician PPA investments on the part of ETC Facility PPA adjustments from +10 and Facility PPA in response to the Participants, the Model provides higher percent and ¥13 percent for MY9 and comments received. CMS also disagrees payments to those ETC Participants who MY10 to +2.75 percent and ¥3.25 that the proposed PPA would incent produce results. Regarding the percent for MY9 and MY10, reasoning ETC Participants to push ESRD commenters’ suggestion that CMS that these lower margins are similar to Beneficiaries into clinically or socially proceed with a budget-neutral or those used in ESRD QIP, which the inappropriate modalities. CMS believes budget-saving model, CMS expects the commenter believed has been successful that ESRD facilities and Managing ETC Model will be a budget-saving in driving behavior. Other commenters Clinicians alike will continue to act in model. Specifically, CMS anticipates similarly urged CMS to align the their patients’ best interest, and will that the Model will reduce Medicare magnitude of the PPA adjustments to respond to the Model’s financial expenditures, and will likely generate that seen in the ESRD QIP. Two incentives, including the PPA, with long-term cost savings by reducing the commenters recommended that the positive behavior change and creativity total costs of care, just as the commenter negative PPA adjustment be limited to in appropriately increasing beneficiary suggested. Regarding the rationale for a maximum of ¥2 percent, one of access to home dialysis while being the magnitude of the PPAs, CMS whom viewed as aligning with the mindful of social issues, such as social proposed the magnitude of the Facility ESRD QIP, and other commenters isolation. PPA and Clinician PPA after careful expressed a belief that the ¥2 percent Comment: A few commenters consideration, hoping to provide a penalty from the ESRD QIP has expressed concern that the proposed robust incentive to drive significant produced results. One of these two PPA appeared to be designed to reduce behavior change among ETC commenters also recommended that this Medicare payments to ESRD facilities Participants without causing harm to reduction to the negative PPA and Managing Clinicians over the beneficiaries. As described later in this adjustment could be accompanied by a duration of the Model. One such final rule, CMS is reducing the corresponding reduction in the positive commenter expressed opposition to magnitude of the PPAs in response to PPA adjustment. Another commenter using the ETC Model to cut Medicare comments received, which should recommended that CMS implement a payments, reasoning that ETC lessen the concerns expressed by payment methodology similar to that Participants would need to make commenters that the PPA will impose used in the ESRD QIP, wherein increased investments to achieve the too much downside risk on ETC attainment and improvement would be delivery system reform that CMS Participants. Finally, CMS disagrees determined using a method like that envisions, which would be more with the comments recommending that used in the ERSD QIP rather than based difficult with less money. A few CMS either eliminate the downside risk on performance relative to Comparison commenters recommended that CMS of the PPA but keep the upward Geographic Areas or the ETC proceed with a budget-neutral or adjustment or simply eliminate the PPA Participant’s own historical budget-saving model. One such altogether. The PPA, by providing performance. commenter recommended that a budget- meaningful downside risk, represents Response: CMS understands the neutral or budget-saving model could the most important incentive in the provide positive incentives and commenters’ concern about the Model for encouraging ESRD facilities magnitude of the PPA, and specifically resources for ESRD facilities to increase and Managing Clinicians to increase the their provision of home dialysis and the downside risk of the PPA. After volume of home dialysis services and transplant-related services, while taking into consideration these transplants. reducing the total cost of care to comments, CMS also agrees that the Medicare in the long run by generating Comment: Several commenters proposed magnitudes of the Facility savings through improved care quality. expressed concern over the proposed PPA and Clinician PPA were higher Other commenters recommended that magnitude of the PPA, especially the than necessary to achieve the Model’s CMS eliminate the downside risk in the magnitude of the potential downward goals. However, CMS believes that they proposed PPA and provide only bonus adjustments from the PPA. Some were not much higher than necessary. payments. A few commenters expressed commenters recommended that CMS Thus, while CMS is reducing the concern that the proposed PPA was set reduce the magnitude of the PPA as magnitude of the PPAs in response to arbitrarily or without a rationale for its compared to what was proposed. A comments received, which should magnitude, and/or that CMS failed to commenter recommended that CMS lessen the concerns expressed by provide an articulated and substantial reduce the downward payment commenters that the PPA will impose defense of the magnitude of the PPA adjustments for the initial MYs to too much downside risk on ETC under the Model. One such commenter encourage ETC Participants to commit Participants, CMS declines to adopt the characterized the PPA as reducing resources and make early investments in specific alternatives suggested by the Medicare payments to ESRD facilities infrastructure needed to succeed in the commenters. First, CMS notes that the and Managing Clinicians every year, Model. A commenter recommended that PPA adjustments are structured even if those ESRD facilities and CMS modify the PPA such that potential differently from the ESRD QIP Managing Clinicians improve their upward adjustments exceed potential adjustments in that an ETC Participant performance. downward adjustments. Another can receive a positive PPA, whereas the Response: Congress established the commenter expressed concern over the ESRD QIP adjustments do not offer the Innovation Center to design and test proposed magnitude of the negative possibility of a positive adjustment to innovative payment and service PPA adjustment given the commenter’s facilities (which are the only entities delivery models, like this ETC Model, belief that the home dialysis rate and that can participate in the program). that are expected to reduce Medicare transplant rate measures are often Second, commenters’ recommendations expenditures while preserving or unrelated to providers’ and suppliers’ that CMS reduce the magnitude of the enhancing the quality of care. While actual rates of performance. Other PPA adjustments to as low as +2.75 CMS understands the commenters’ commenters offered more concrete percent/¥3.25 percent (or lower) would concerns that moving toward more alternatives. A commenter not provide the level of incentive to

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increase home dialysis and transplant its magnitude is reduced, and we find (1) Facility PPA rates that CMS sees as necessary to this change to be most appropriate in For ESRD facilities that are ETC effectuate meaningful behavior change. light of the comments received globally. Participants, as described in proposed The PPA amounts that CMS is finalizing Modifying this Model to be an § 512.325(a) (Selected Participants), we in this rule optimally balance CMS’s Advanced APM would require that we proposed to adjust certain payments for interests in achieving the Model’s goals subject ETC Participants to significant renal dialysis services by the Facility while not imposing too much financial downside risk starting in MY1, which PPA. Specifically, we would adjust the risk on ETC Participants. The PPA we believe would put many ETC Adjusted ESRD PPS per Treatment Base amounts begin at around the same level Participants in a difficult financial Rate for claim lines with Type of Bill of the payment adjustments under MIPS position. Instead, we believe that 072x, where the type of facility code is (which, for 2020, generally are +/¥5 adjusting payments by the HDPA only 7 and the type of care code is 2, and for percent subject to a scaling factor), and during the first two MYs and then which the beneficiary is 18 or older for then gradually increase in magnitude introducing the PPA adjustments is the the entire month and where the claim over time. CMS believes that generally most appropriate design given the through date is during the applicable following the MIPS payment adjustment Model’s articulated goals and the PPA Period as described in proposed amounts in PPA Period 1 of the ETC comments received. Regarding the § 512.355(c) (Measurement Years and Model will provide an initial incentive recommendation that CMS exempt amount that some ETC Participants have Performance Payment Adjustment Managing Clinicians who are ETC Periods). We explained in the proposed become accustomed to under MIPS, and Participants from MIPS, it is not clear thus which should be manageable, rule that facility code 7 paired with type that the Innovation Center has the of care code 2 indicates that the claim before the magnitude of the PPA authority to categorically exempt any gradually increases. The financial risk occurred at a clinic or hospital based eligible clinicians, including Managing ESRD facility. Type of Bill 072X imposed on ETC Participants by the Clinicians as that term is defined for PPA will be incremental given this therefore captures all renal dialysis purposes of this Model, from MIPS. services furnished at or through ESRD gradual increase, and will eventually Moreover, even if CMS had the provide a stronger incentive than that facilities. As with the HDPA, we authority to exempt Managing proposed to apply the Facility PPA to currently offered under MIPS or the Clinicians from MIPS, CMS believes this ESRD QIP program, but without asking claims where Medicare is the secondary would undermine MIPS. MIPS provides payer. ETC Participants to take on the same important incentives based on, among level of risk they might under another We proposed that the formula for other things, performance on quality determining the final ESRD PPS per model tested under section 1115A of the and cost measures that this Model does Act, such as the KCC Model. For treatment payment amount with the not. This Model is not intended to Facility PPA would be as follows: example, under the CMS Kidney Care replace MIPS, but instead to place First (KCF) option of the KCC Model, emphasis on increasing rates of home Final ESRD PPS Per Treatment Payment KCF Participants that perform poorly in dialysis and transplants. Amount with PPA = ((Adjusted terms of quality and utilization may ESRD PPS per Treatment Base Rate receive a downward adjustment of up to After reviewing public comments, we * Facility PPA) + Training Add On 20 percent to certain payments under are finalizing our general proposals + TDAPA) * ESRD QIP Factor + the model. regarding the Performance Payment Outlier Payment * ESRD QIP Factor Comment: Several commenters Adjustment, with modifications. CMS will modify the proposed schedule for We further proposed that, for time recommended that CMS redesign the periods and claim lines for which both PPA such that the ETC Model is an the Facility PPA and Clinician PPA in our regulation at § 512.380 in the Facility HDPA and the Facility PPA Advanced APM. Another commenter apply, the formula for determining the who recommended that CMS eliminate accordance with the revised start date for the payment adjustments under the final ESRD PPS per treatment payment the PPA altogether reasoned that amount would be as follows: nephrologists who are MIPS eligible ETC Model, described in section IV.C.1 Final ESRD PPS Per Treatment Payment clinicians already participate in MIPS, of this final rule. In addition, after Amount with PPA and HDPA = which subjects those nephrologists to reviewing the comments regarding the ((Adjusted ESRD PPS per Treatment positive or negative payment proposed magnitude of the PPA Base Rate* (Facility HDPA + adjustments based on performance, and amounts, we are reducing the that unless the ETC Model is redesigned magnitude of the PPA amounts. Facility PPA)) + Training Add On + to qualify as an Advanced APM, such Specifically, relative to the magnitude of TDAPA) * ESRD QIP Factor + nephrologists will be subjected to two the PPA amounts described in the Outlier Payment * ESRD QIP Factor uncoordinated pay-for-performance proposed rule, CMS is reducing the As discussed previously in sections initiatives. Two commenters magnitude of the maximum PPA II.B.1 and IV.C.4.b of this final rule, after recommended that CMS exempt amounts each PPA period by 2 percent. we published the proposed rule for the Managing Clinicians participating in the We chose to reduce the PPA amounts by ETC Model, CMS established a new ETC Model from MIPS. 2 percentages points in response to payment adjustment under the ESRD Response: We appreciate the commenter feedback that the proposed PPS called the TPNIES, which could recommendations from the commenters, PPA amounts were too high, and to apply to certain claims as soon as CY but we decline to adopt either. We more closely align the finalized PPA 2021. The TPNIES is part of the received many comments expressing amounts with the payment adjustments calculation of the ESRD PPS per concern about the magnitude of the under MIPS, which generally will be +/ treatment payment amount under 42 PPA, and nearly as many comments ¥7% in 2021 and +/¥9% in 2022, CFR 413.230 and, like the TDAPA, is recommending that we reduce the subject to a scaling factor. The specific applied after the facility-level and magnitude, especially the negative final magnitudes of the Facility PPA and patient-level adjustments. We discuss magnitude, of the PPA. We have the Managing Clinician PPA are the implications of this change for the responded to those comments by discussed in sections IV.C.5.e.(1) and Facility PPA later in this section of the modifying the proposed PPA such that IV.C.5.e.(2) of this final rule. final rule.

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Table 14 depicts the proposed which we proposed to codify in amounts and schedule for the Facility proposed § 512.380. PPA over the ETC Model’s PPA periods,

Also, as we described in the proposed ETC Participant believes home dialysis PPS per treatment payment amount rule and in section IV.C.7.a of this final is the most appropriate modality for the with the Facility PPA will reflect the rule, we proposed that the Facility PPA beneficiary. Second, we note that any addition of the TPNIES. Because CMS would not affect beneficiary cost dialysis claim submitted for an ESRD would apply the TPNIES in the sharing. Beneficiary cost sharing would Beneficiary after the claim containing calculation of the per treatment instead be based on the amount that condition code 73 would be adjusted by payment amount after the application of would have been paid under the ESRD the Facility PPA, providing a robust the patient-level adjustments and PPS absent the Facility PPA. enough incentive to ETC Participants to facility-level adjustments, in the same The following is a summary of the increase the provision of home dialysis manner as the TDAPA, the TPNIES does comments received on the proposed services. Further, if CMS were to adjust not alter the proposed application of the Facility PPA and our responses. claims containing condition code 73 by Facility PPA. We had proposed to adjust Comment: A few commenters the Facility PPA and an ESRD facility the Adjusted ESRD PPS per Treatment expressed support for the proposal to received a negative Facility PPA, the Base Rate, meaning the per treatment apply the Facility PPA to claims where ESRD facility would face a disincentive payment amount as defined in Medicare is the secondary payer. to train ESRD Beneficiaries on home § 413.230, including patient-level Response: We appreciate this dialysis. CMS therefore believes it is adjustments and facility-level feedback and support from the most appropriate to exclude claims with adjustments and excluding any commenters. condition code 73 from the payments applicable training adjustment add-on Comment: A few commenters adjusted by the Facility PPA. payment amount, outlier payment recommended that CMS include Comment: A commenter expressed amount, and TDAPA amount, by the condition code 73 in the types of claims support for the proposal that the Facility Facility PPA. We are revising the adjusted by the Facility PPA, as PPA would not affect beneficiary cost formula for determining the final ESRD condition code 73 corresponds to home sharing, reasoning that beneficiaries PPS per treatment payment amount dialysis training. included in the Model should not be with the Facility PPA alone and the Response: We thank the commenters financially harmed or be discouraged Facility PPA and Facility HDPA to for their feedback. As noted previously from obtaining care necessary to obtain reflect the addition of the TPNIES be as in this final rule, condition code 73 is optimal patient health outcomes. A follows: related to training a beneficiary on home commenter expressed concern that CMS Final ESRD PPS Per Treatment Payment dialysis and the inclusion of this code did not explain in the proposed rule Amount with PPA = ((Adjusted on a claim is one way in which CMS how the PPA would impact ESRD ESRD PPS per Treatment Base Rate determines the start of Medicare Beneficiary co-insurance. * Facility PPA)) + Training Add On coverage for an ESRD Beneficiary. CMS Response: We thank the commenters + TDAPA + TPNIES) * ESRD QIP believes it is unnecessary and for their feedback and support. In the Factor + Outlier Payment * ESRD inappropriate to include condition code proposed rule, we indicated that the QIP Factor 73 in the payments adjusted by the PPA. PPA would not affect beneficiary cost Final ESRD PPS Per Treatment Payment First, as noted previously in this final sharing. We clarify that cost sharing Amount with PPA and HDPA = rule, under the ETC Model, CMS seeks refers to both the deductible and ((Adjusted ESRD PPS per Treatment to adjust payments for and incentivize beneficiary co-insurance. As described Base Rate* (Facility HDPA + the provision of home dialysis services, in the proposed rule, beneficiary cost Facility PPA)) + Training Add On + and not home dialysis training per se, sharing would instead be based on the TDAPA + TPNIES) * ESRD QIP and adjusting payments for claims that amount that would have been paid Factor + Outlier Payment * ESRD include condition code 73 may under the ESRD PPS absent the Facility QIP Factor encourage ‘‘gaming’’ wherein ETC PPA. Participants train all beneficiaries on In addition, we are clarifying that the We note that, under our regulations at home dialysis, regardless of whether the formula for calculating the final ESRD § 512.355, the PPA will not apply to any

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claims until the first PPA Period, which While we had proposed to apply the we are finalizing using the date of starts on July 1, 2022. PPA only to claims for which the service on the claim, to align with After considering public comments, beneficiary was 18 years of age or older Medicare claims processing standards. we are finalizing our proposed for the entire month of the claim, in the Specifically, while Medicare claims data provisions for the Facility PPA, with final rule we are modifying the language contains both claim through dates and modification. Specifically, we are to state that the beneficiary must be age dates of service, Medicare claims are modifying the magnitude of the Facility 18 or older ‘‘before the first day of the processed based on dates of service. PPA for each MPS and each PPA Period month,’’ which is easier for CMS to Thus, we must use the claim date of relative to what we proposed, as operationalize and has the same service to identify the PPA Period in described in Table 14.a, and codifying practical effect (that is, a beneficiary which the service was furnished. We are the modified Facility PPA in Table 1 to who is at least 18 years old before the also modifying the definition of our regulation at § 512.380. We are first date of a month will be at least 18 finalizing in our regulation at years old for that entire month). We are Adjusted ESRD PPS per Treatment Base § 512.375(a) that the PPA will adjust the also modifying which date associated Rate in our regulation at § 512.310 to Adjusted ESRD PPS per Treatment Base with the claim we are using to reflect that it excludes any applicable Rate, as proposed, as well as that the determine if the claim occurred during TPNIES amount, as discussed PPA will apply only to claims for the applicable PPA Period. Whereas we previously in section IV.C.4.a and this beneficiaries 18 years of age or older. proposed using the claim through date, section of the final rule.

(2) Clinician PPA entire month and where the claim dialysis per full month, and indicate the through date is during the applicable age of the beneficiary (12–19 or 20 years For Managing Clinicians that are ETC PPA Period as described in proposed of age or older). Taken together, these Participants, as described in proposed § 512.355(c) (Measurement Years and codes are used to bill the MCP for § 512.325(a) (Selected Participants), we Performance Payment Adjustment ESRD-related services furnished to proposed to adjust payments for Periods). We explained in the proposed beneficiaries age 18 and older, including managing dialysis beneficiaries by the rule that CPT® codes 90957, 90958, patients who dialyze at home and Clinician PPA. Specifically, we would 90959, 90960, 90961, and 90962 are for patients who dialyze in-center. As with adjust the amount otherwise paid under ESRD-related services furnished the HDPA, we proposed to apply the Part B with respect to the MCP claims monthly, and indicate beneficiary age Clinician PPA to claims where Medicare on claim lines with CPT® codes 90957, (12–19 or 20 years of age or older) and is the secondary payer. 90958, 90959, 90960, 90961, 90962, the number of face-to-face visits with a Table 15 depicts the proposed 90965, or 90966, by the Clinician PPA physician or other qualified health care amounts and schedule for the Clinician when the claim is submitted by an ETC professional per month (1, 2–3, 4 or PPA over the ETC Model’s PPA periods, Participant who is a Managing Clinician more). CPT® codes 90965 and 90966 are which we proposed to codify in and the beneficiary is 18 or older for the for ESRD-related services for home proposed § 512.380.

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We proposed to adjust the amount modifying the amounts of the Clinician operationalize and has the same otherwise paid under Part B by the PPA from those proposed, to reduce the practical effect (that is, a beneficiary Clinician PPA so that beneficiary cost magnitude of the Clinician PPA for each who is at least 18 years old on the first sharing would not be affected by the MPS and PPA Period relative to what date of the month will be at least 18 application of the Clinician PPA. The we proposed, as described in Table 15.a, years old for that entire month). We are Clinician PPA would apply only to the and codifying the modified Clinician modifying which date associated with amount otherwise paid for the MCP PPA in Table 2 to our regulation at the claim we are using to determine if absent the Clinician PPA. § 512.380. We are finalizing that the the claim occurred during the The following is a summary of the Clinician PPA will adjust the amount applicable PPA Period. Whereas we otherwise paid for the MCP as proposed, comments received on the proposed proposed using the claim through date, Clinician PPA and our responses. as well as that the Clinician PPA will we are finalizing using the date of Comment: A commenter expressed only apply to claims for beneficiaries 18 service on the claim, to align with support for CMS’s proposal to apply the years of age or older. While we had Clinician PPA to claims where Medicare proposed to apply the Clinician PPA Medicare claims processing standards. is the secondary payer. only to claims for which the beneficiary Specifically, while Medicare claims data Response: We thank the commenter was 18 years of age or older during the contains both claim through dates and for the feedback and support. entire month of the claim, we are dates of service, Medicare claims are After considering public comments, changing the language to state that the processed based on dates of service. we are finalizing our proposed beneficiary must be at least 18 years of Thus, we must use the claim service provisions for the Clinician PPA, with age ‘‘before the first date of the month,’’ date to identify the PPA Period in which modification. Specifically, we are which is easier for CMS to the service was furnished.

f. Low-Volume Threshold Exclusions for from the application of the PPA during in the proposed rule and in section the PPA the corresponding PPA Period. Each IV.C.5.b of this final rule, meaning that (1) ESRD Facilities beneficiary-year would be equivalent to an ESRD facility must have at least 132 12 attributed beneficiary months, where total attributed beneficiary months for a We proposed excluding ETC a beneficiary month is one calendar MY in order to be subject to the PPA for Participants that are ESRD facilities that month for which an ESRD Beneficiary is the corresponding PPA Period. Under have fewer than 11 attributed attributed to an ETC Participant using our proposal, a beneficiary year could beneficiary-years during a given MY the attribution methodology described be comprised of attributed beneficiary

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months from multiple beneficiaries. We financial losses in 2017, only 64 of these receive home dialysis or a transplant, proposed this exclusion threshold to ESRD facilities would be designated as would be forced to close due to the increase statistical reliability and to ‘‘low-volume’’ under the Model and application of the Facility PPA. The exclude low-volume ESRD facilities thus be excluded from the application of same commenter recommended that from the application of the Facility PPA. the Facility PPA. Another commenter CMS make its low-volume exclusion We selected this particular threshold expressed concern that rural ESRD based on an attestation that the ESRD because it is similar to the 11 qualifying facilities, which often have few insured facility is a low-volume facility. patient minimum threshold that the patients and high numbers of patients Response: We thank the commenters ESRD QIP uses for purposes of scoring with little support at home, will not and for their feedback. Regarding the certain measures during the cannot perform well in the Model, and comment that the need to promote home performance period. In the proposed may be forced to close, leaving rural dialysis outweighs the reasons CMS rule, we stated that we had considered beneficiaries without access to care. A cited for proposing the low-volume using the 11 qualifying patients commenter recommended that an ESRD exclusion for ESRD facilities, we must threshold used for purposes of scoring facility farther than 20 miles away from some measures under the ESRD QIP, but the next nearest ESRD facility should underscore that statistical reliability is due to differences in beneficiary not be subjected to negative payment essential for determining whether the attribution methodologies between the adjustments, but still be able to receive financial incentives offered in this ESRD QIP and the proposed ETC Model, positive payment adjustments, Model can significantly alter the we concluded that using beneficiary- reasoning that if such an ESRD facility provision of home dialysis. Further, years was more appropriate for purposes performs poorly, it may have to close CMS hopes that all ESRD facilities, of testing the ETC Model, as the rates and cause its patients to travel much regardless of participation in the ETC proposed for the ETC Model are based farther to receive care. Another Model, will promote home dialysis and on beneficiary-years. commenter suggested that CMS use the educate their patients regarding all renal We invited public comment on our ESRD PPS definition of a ‘‘low-volume replacement modalities, including home proposal for excluding ESRD facilities facility’’ and not apply negative PPA dialysis modalities. Moreover, creating a with fewer than 11 attributed adjustments to those ESRD facilities. virtual group for small and low-volume beneficiary-years from the application of Another commenter recommended that ESRD facilities, as suggested by the the PPA during the applicable PPA CMS still apply positive PPA commenter, would be unduly complex Period, as well as the alternatives adjustments to ESRD facilities excluded operationally, as described previously considered. under the low-volume exclusion, but in this final rule. We are also concerned The following is a summary of the not subject them to negative PPA that it would be difficult to define comments received on the proposed adjustments. virtual groups for purposes of the low- low-volume exclusion from the volume threshold for ESRD facilities application of the PPA for ESRD Another commenter recommended that CMS broaden the proposed low- without inadvertently giving either the facilities and our responses. virtual group, or those ESRD facilities Comment: A commenter expressed volume exclusion for ESRD facilities to exclude from the application of the PPA not in the virtual group, an unfair opposition to the proposed low-volume advantage. In addition, as discussed exclusion for ESRD facilities, opining all low-volume and rural ESRD facilities later in this section of the final rule, that CMS’s reasons for proposing the owned by organizations with 35 or CMS will calculate the low-volume low-volume exclusion for ESRD fewer ESRD facilities, unless the ESRD threshold for ESRD facilities at the level facilities do not outweigh the need to facility voluntarily elects to be subject to of the aggregation group (as described in promote home dialysis to patients of the PPA, reasoning that low-volume and low-volume facilities who want such rural ESRD facilities are our regulation at § 512.365(e)(1)), under services. The same commenter disproportionately less likely to offer which CMS will aggregate all ESRD recommended that instead of a low- home dialysis therapy, and that a facilities that are not Subsidiary ESRD volume exclusion for ESRD facilities, substantial number of low-volume and facilities with all other ESRD facilities CMS should create a mechanism for rural ESRD facilities are small and that are not Subsidiary ESRD facilities small and low-volume ESRD facilities to independent providers that operate with located within the same HRR. Because aggregate their performance to a virtual negative Medicare margins and lack CMS is not aggregating independent or group to strengthen the ability of these sufficient resources to make the ESRD facilities that are not Subsidiary ESRD facilities to perform in the Model. investments necessary to establish a ESRD facilities, CMS will apply the low- The same commenter expressed concern home dialysis program. The same volume threshold exclusion policy to that excluding ESRD facilities from the commenter expressed concern that the ESRD facilities that are not Subsidiary application of the PPA based on volume current low-volume exclusion policy for facilities at the facility level. As alone may not be sufficiently nuanced ESRD facilities is inadequate to protect described elsewhere in this final rule, to account for ESRD facilities that serve beneficiary access to care and prevent an aggregation group pools the an important access need, and thus further market consolidation. Another performance of several ESRD facilities serve a relatively high volume of ESRD commenter recommended that CMS in a particular HRR and thus strengthen Beneficiaries, but that are unable to bear provide an exclusion for low-volume their ability to perform in the Model. downside financial risk. ESRD facilities and for Managing Applying the low-volume threshold On the other hand, another Clinicians providing services at low- exclusion policy at the aggregation commenter expressed concern that the volume ESRD facilities. The same group level, as discussed below, allows proposed low-volume exclusion for commenter expressed concern that CMS to more precisely exclude ESRD ERSD facilities would cover only a small and independent facilities that facilities who may be unlikely to small number of ESRD facilities which have 12 ESRD Beneficiaries (and thus perform adequately under the Model operate with narrow profit margins or would not be excluded from the due to low historical beneficiary even narrow losses. The same application of the Facility PPA under attribution, while bolstering statistical commenter provided data suggesting of our proposed low-volume exclusion), all reliability. CMS believes that this policy the 353 rural ESRD facilities reporting of whom are unable or unwilling to sufficiently addresses the concerns the

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commenter intended to address in build upon home dialysis programs, facilities to improve home dialysis and, recommending the virtual group policy. which will help position ESRD facilities ultimately, transplant rates. While we agree with the commenter to earn a higher PPA. While it is After considering public comments, that volume alone may not be possible that an ESRD facility could we are finalizing our proposed sufficiently nuanced to account for all have 12 ESRD Beneficiaries, all of provisions on the low volume exclusion ESRD facilities that serve an important whom are not appropriate candidates for ESRD facilities, with modification. access need but are unable to bear for either home dialysis or a transplant, Specifically, in an effort to limit the downside financial risk, part of CMS’s CMS finds this situation to be highly scope of the low-volume exclusion in reasoning for pursuing the low-volume unlikely. However, if an ESRD facility order to promote modality choice with exclusion is to bolster statistical found itself in that situation, the ESRD the need for statistical reliability, CMS reliability, which ultimately benefits facility could still perform well under is modifying its proposal such that, ETC Participants. Similarly, even if the Model by focusing attention on under the ETC Model, CMS will exclude CMS’s proposed low-volume exclusion educating its ESRD Beneficiaries on self- aggregation groups (as described in our does not exclude from the application of dialysis and transplantation, and regulation at § 512.365(e)(1)) of ESRD the PPA all ESRD facilities operating encouraging and helping its ESRD facilities with fewer than 11 attributed with a near-zero or negative profit Beneficiaries to register for a transplant ESRD beneficiary years during an MY margin, (1) CMS reiterates its need to waitlist. from the application of the Facility PPA assure statistical reliability in the Regarding the comment that CMS for the corresponding PPA Period. CMS should provide an exclusion for low- will similarly exclude ESRD facilities calculation of the PPA, and (2) the ETC volume ESRD facilities, this is what we that are not Subsidiary ESRD facilities Model offers such ESRD facilities an proposed to do; however, we disagree with fewer than 11 attributed ESRD opportunity to increase revenue through with the alternative low-volume beneficiary years during an MY from the the payment adjustments, depending thresholds recommended by the application of the Facility PPA for the upon their performance. Similarly, CMS commenters. Regarding the comment corresponding PPA Period. This policy believes that the commenter’s concerns suggesting that CMS make its low- is also consistent with our final policy about rural ESRD facilities are volume exclusion for ESRD facilities for assessing ESRD facility performance unfounded, as the home dialysis rate based on an attestation that the facility for purposes of the MPS calculation, measure captures the percentage of an is low-volume, CMS is concerned that which will also occur at the aggregation ESRD facility’s ESRD Beneficiaries who such a policy would lead to gaming and group level. Because the low-volume use a home dialysis modality. ESRD abuse in the context of this Model. threshold determination will generally facilities currently operating with thin While CMS requires attestations from be made at the aggregation group level profit margins could see those margins ESRD facilities that qualify as ‘‘low (that is, across multiple Subsidiary grow by investing capital in creating or volume’’ under the ESRD PPS, the ESRD facilities), under this final policy, building upon home dialysis or self- Model is using a different policy for fewer ESRD facilities will be excluded dialysis programs, thus reducing their identifying ‘‘low volume’’ than that from the application of the Facility PPA costs associated with providing dialysis used under the ESRD PPS, and as compared to the number that would services in-center multiple days a week operational limitations render have been excluded under the policy we and potentially earning them a positive attestations and subsequent proposed. This low-volume exclusion is PPA or increasing the magnitude of the confirmation by CMS or its Medicare also narrower than the ESRD PPS PPA earned. Similarly, while rural Administrative Contractors (MACs), as definition suggested by the commenter ESRD facilities may have high numbers is done under the ESRD PPS, unsuitable and accordingly better ensures that a of patients without support at home, the for this Model. CMS also finds its policy greater number of ESRD Beneficiaries Model is designed to incent ESRD for identifying a low-volume ESRD will receive the benefit of receiving care facilities to consider how to increase facility under the Model to be more from an ESRD facility incentivized by access to home dialysis modalities for appropriate than the ESRD PPS the Model to provide home dialysis their ESRD Beneficiaries, and CMS will definition for purposes of the Model, in services, self-dialysis services, and a be including self-dialysis in the home light of the goals of the Model and robust pathway to transplantation. By dialysis rate measure, as discussed CMS’s need for statistically reliable contrast, the ESRD PPS definition of elsewhere in this final rule. If an ESRD data. ‘‘low-volume facility’’ is an ESRD facility has many ESRD Beneficiaries CMS also declines to include the facility that (1) furnished less than 4,000 lacking support at home, such an ESRD commenter’s recommended exclusion treatments in each of the three ‘‘cost facility could prioritize training its for ESRD facilities located more than 20 reporting years . . . preceding the ESRD Beneficiaries on self-dialysis miles away from another ESRD facility payment year;’’ and (2) ‘‘[h]as not rather than home dialysis, which would, at this time. While CMS understands the opened, closed, or received a new like home dialysis, give the beneficiaries commenter’s concern, an exclusion of provider number due to a change of greater agency in their treatment and this nature could give rise to gaming, ownership’’ in the same time period. 42 help the ESRD facility improve its insofar as ETC Participants that are CFR 413.232(b). This definition captures performance under the Model. CMS newly building spaces for home dialysis a larger number of ESRD facilities than believes that the proposed low-volume training and self-dialysis could does the low-volume facility provision exclusion, with the modifications strategically position new ESRD in this final rule. described in this section of the final facilities more than 20 miles away from We are codifying the modified low- rule, is sufficient to ensure beneficiary other ESRD facilities. Finally, regarding volume threshold for ESRD facilities in access to care and will not result in the comment recommending that CMS § 512.385(a) of our regulation. market consolidation, and that the apply positive PPAs to ESRD facilities Model, through the HDPA, will provide otherwise excluded from the application (2) Managing Clinicians ESRD facilities that are not excluded of the PPA, but exclude such facilities We proposed excluding ETC from the application of the PPA with from any negative PPAs, CMS believes Participants that are Managing greater financial resources during the this would not produce a strong enough Clinicians who fall below a specified initial years of the Model to establish or financial incentive for such ESRD low-volume threshold during an MY

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from the application of the PPA during that CMS give otherwise excluded attributed ESRD beneficiary years. As the corresponding PPA Period. The low- Managing Clinicians the option to opt in with the modified low-volume volume exclusion would ensure that we to the application of the PPA under exclusion policy for ESRD facilities would be adjusting payment based on Model. described elsewhere in this section of reliable measurement of Managing Response: We thank the commenters the final rule, this modified low-volume Clinician performance. We noted that for their feedback and support. exclusion policy for Managing Managing Clinicians with sufficiently Regarding the commenter’s suggestion Clinicians allows CMS to more precisely small attributed beneficiary populations that CMS allow otherwise excluded exclude groups of ETC Participants that may serve unique patient populations, Managing Clinicians to opt in to the have low historical beneficiary such as children, such that we may not application of the PPA under the Model, attribution from application of the PPA, be able to produce statistically reliable we decline to adopt this while bolstering statistical reliability. transplant rates and home dialysis rates recommendation because Managing CMS noted in the proposed rule that for these Managing Clinicians. We Clinicians who are ETC Participants ESRD facilities and Managing Clinicians proposed that the low-volume threshold must treat at least a minimum volume are different, in that Managing would be set at the bottom five percent of ESRD Beneficiaries in order for CMS Clinicians are more diverse as compared of ETC Participants who are Managing to produce statistically reliable to ESRD facilities, in terms of both Clinicians in terms of the number of transplant rates and home dialysis rates volume of services furnished to beneficiary-years for which the for purposes of calculating the beneficiaries related to receiving Managing Clinician billed the MCP Managing Clinicians’ MPS and dialysis and services furnished that are during the MY. We stated in the corresponding Clinician PPA. However, not related to dialysis. While CMS still proposed rule that we considered using CMS determined, after publishing the believes this to be true, CMS determined 11 beneficiary-years as the low-volume NPRM, that the policy described in the subsequent to publishing the NPRM that exclusion for Managing Clinicians, to NPRM would not exclude Managing the Managing Clinician low-volume mirror the proposed exclusion for ESRD Clinicians with adequate precision. In threshold exclusion policy described in facilities. However, we recognized that other words, our proposed policy would the NPRM would not precisely exclude ESRD facilities and Managing Clinicians result in CMS applying the PPA to Managing Clinicians with too few are different in that Managing Clinicians Managing Clinicians who have far fewer attributed ESRD beneficiary years to are more diverse, as compared to ESRD attributed beneficiary years than we obtain statistical reliability. facilities, in terms of both volume of expected and need for the purpose of Accordingly, to obtain statistical services furnished to beneficiaries achieving statistical reliability. reliability, CMS must modify its related to receiving dialysis and services Accordingly, CMS is modifying its proposal to set the Managing Clinician furnished that are not related to dialysis. proposal for the Managing Clinician low-volume threshold exclusion at 132 Therefore, we proposed using a low-volume threshold exclusion, as attributed ESRD beneficiary months, or percentile-based low-volume exclusion described below. 11 attributed ESRD beneficiary years. threshold for Managing Clinicians that After considering public comments, This modification will result in a higher would help to ensure statistical we are modifying our proposed number of Managing Clinicians being soundness while recognizing the provisions on the low volume exclusion excluded from the Model. Finally, CMS diversity of the Managing Clinician for Managing Clinicians. Specifically, is making the change from considering population. In the proposed rule, we we are changing the low-volume ‘‘beneficiary-years’’ to ‘‘attributed ESRD alternatively considered establishing the threshold for excluding Managing beneficiary-years’’ to conform to the low-volume threshold based on the Clinicians from the application of the low-volume threshold exclusion for bottom five percent of Managing PPA during the applicable PPA Period ESRD facilities, as ESRD facilities will Clinicians who are ETC Participants in from excluding Managing Clinicians in not have attributed Pre-emptive LDT the total dollar value of Medicare claims the bottom five percent of ETC Beneficiaries. We are codifying this low- paid. However, as Managing Clinicians Participants who are Managing volume exclusion in § 512.385(b) of our are in a variety of specialties and Clinicians in terms of the number of regulation. provide a wide range of services that are beneficiary-years for which the g. Notification paid at a variety of rates, we concluded Managing Clinicians billed the MCP that a dollar-value threshold was not during the MY, as proposed, to Per the PPA schedule, we proposed suitable for purposes of this proposed excluding Managing Clinicians in an that payment adjustments would be exclusion. aggregation group (as described in our made during the PPA period that begins We invited public comment on this regulation at § 512.365(e)(2)) with fewer 6 months after the end of the MY. This proposal for excluding certain Managing than 11 attributed ESRD beneficiary- 6-month period would allow for 3 Clinicians from the application of the years during an MY. Determining the months claims run-out to account for lag PPA during the applicable PPA Period low-volume threshold for a Managing in claims processing, and for CMS to based on our proposed low volume Clinician at the aggregation group level calculate and validate the MPS and the threshold, as well as the alternatives conforms to changes CMS made to the corresponding PPA for each ETC considered. ESRD facility low-volume exclusion Participant. After we calculate ETC The following is a summary of the policy, described above, and also is Participant MPSs and PPAs, we comments received on the proposed consistent with our final policy for proposed to notify ETC Participants of low-volume exclusion from the assessing ESRD facility performance for their attributed beneficiaries, MPSs and application of the PPA for Managing purposes of the MPS calculation, which corresponding PPAs. We proposed Clinicians and our responses. will also occur at the aggregation group notification of ETC Participants no later Comment: A commenter expressed level. CMS is similarly changing its than 1 month before the start of the PPA support for the proposed low-volume policy from setting the exclusion level Period in which the PPA would go into exclusion for Managing Clinicians. at the bottom five percent of ETC effect. As stated in the proposed rule, Another commenter expressed support Participants who are Managing we believe this notification period for the proposed low-volume exclusion Clinicians in terms of the number of balances the need for sufficient claims for Managing Clinicians, but suggested beneficiary-years to fewer than 11 run-out to ensure accuracy, as well as

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sufficient time for MPA and PPA Medicare FFS issues experienced by the responsiveness to the request for calculation and validation by CMS, with ETC Participant that occur during their additional information would our interest in providing sufficient participation in the ETC Model that do potentially result in the closure of the advanced notification regarding the not involve the calculation of the MPS), targeted review request. If we were to resulting payment adjustments to ETC then the ETC Participant should find, after conducting a targeted review, Participants. continue to use the standard CMS that there had been an error in the We proposed to conduct notifications procedures through their MAC. Section calculation of the ETC Participant’s in a form and manner determined by 1869 of the Act provides for a process MPS, we would notify the ETC CMS. The following is a summary of the for Medicare beneficiaries, providers, Participant within 30 days of the comment received on proposed and suppliers to appeal certain claims finding. If the error in the MPS were notifications and our response. and decisions made by CMS. such that it caused us to apply an Comment: A commenter expressed We proposed that ETC Participants incorrect PPA during the PPA Period concern that providing reports regarding would be able to request a targeted associated with the incorrect MPS, we the ETC Participant’s attributed review of the calculation of their MPS. would notify the ETC Participant and beneficiaries, MPS, and PPA for a PPA ETC Participants would be able to resolve the payment discrepancy during Period only once per year would be request a targeted review for certain the next PPA Period following insufficient and would not provide the considerations, including, but not notification of the MPS error. We information necessary for ETC limited to, when: The ETC Participant proposed that decisions based on the Participants to measure their believes an error has occurred in the targeted review process would be final, performance and take corrective action home dialysis rate or transplant rate and there would be no further review or when necessary. used in the calculation of the MPS due appeal. Response: We thank the commenter to data quality or other issues; or the In the proposed rule, we considered for the feedback. As described in the ETC Participant believes that there are compressing the duration of the targeted proposed rule and previously in this certain errors, such as misapplication of review process such that it could be final rule, each PPA Period will be 6 the home dialysis rate or transplant rate completed before the PPA Period for months long and will begin 6 months benchmark in determining the ETC which the MPS in question sets the after the last date of the corresponding Participant’s achievement score, PPA. However, we stated that we MY. As a result, ETC Participants will improvement score, or the selection of believe that this would be an receive notifications regarding the higher score for use in the MPS. We insufficient amount of time for ETC beneficiary attribution, MPS, and PPA noted in the proposed rule that the Participants to review their MPS, twice per year (that is, every six targeted review process would be consider the possibility of a calculation months)—one month prior to each PPA subject to the limitations on or data error, request a targeted review, Period. We believe this notification administrative and judicial review as and provide additional information to schedule affords CMS the time needed previously described. Specifically, an CMS if requested. collect data, attribute beneficiaries, ETC Participant could not use the The following is a summary of the calculate the MPS and PPA, validate targeted review process to dispute a comment received on the proposed those calculations, and distribute this determination that is precluded from targeted review process and our information to ETC Participants in administrative and judicial review response. accordance with the requirements set under section 1115A(d)(2) of the Act Comment: We received one comment forth in this final rule, while protecting and our regulation at § 512.170. that 60 days would be insufficient time the ETC Participant’s interest in timely To request a targeted review, we for ETC Participants to review their receiving the data, reviewing for proposed that the ETC Participant MPS, identify potential errors, and suspected errors, and implementing would provide written notice to CMS of request a targeted review from CMS. performance improvement strategies for a suspected error in the calculation of The commenter suggested 90 days as an current and subsequent MYs. their MPS no later than 60 days after we alternative. After considering the public notify ETC Participants of their MPS, or Response: We thank the commenter comment, we are finalizing our at a later date as specified by CMS. We for the feedback. After considering the proposed notification provision in our proposed that this written notice must comment, we will adopt a final policy regulation at § 512.390(a) without be submitted in a form and manner that ETC Participants must provide modification. specified by CMS. The ETC Participant written notice to CMS of a suspected would be able to include additional error in the calculation of their MPS no h. Targeted Review information in support of its request for later than 90 days after we notify ETC We noted in the proposed rule that we targeted review at the time the request Participants of their MPS, or at a later believe that it would be advisable to is submitted. date as specified by CMS. This provide a process according to which an We proposed that we would respond modification would be an increase from ETC Participant would be able to to each request for targeted review the 60-day period discussed in the dispute errors that it believes to have submitted in writing in a timely proposed rule. occurred in the calculation of the MPS. manner, and determine within 60 days After considering the public comment Therefore, we proposed a policy that of receipt of the request whether a received, we are finalizing our targeted would permit ETC Participants to targeted review is warranted. We review proposal in our regulation at contest errors found in their MPS, but proposed that we would either accept or § 512.390(b), with modification. As not in the ETC Model home dialysis rate deny the request for targeted review, or noted previously in this section of the calculation methodology, transplant rate request additional information from the final rule, we are increasing the amount calculation methodology, achievement ETC Participant that we would deem of time that an ETC Participant will and improvement benchmarking necessary to make such a decision. If we have to request a targeted review from methodology, or MPS calculation were to request additional information 60 days to 90 days after the ETC methodology. We noted that, if ETC from the ETC Participant, we would Participant is notified of their MPS. We Participants have Medicare FFS claims require that it be provided and received are also modifying the regulatory text at or decisions they wish to appeal (that is, within 30 days of the request. Non- § 512.390(b)(1) to specify that the ETC

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Participant may request a targeted ensure that the MIPS payment beneficiaries receive kidney transplants; review at a later date as specified by adjustment factors would still have a and we proposed that a participant in CMS to align with the proposed policy significant weight for Managing both models would be eligible to receive as described in the preamble to the Clinicians. both types of adjustments under the proposed rule. In addition, we are • Kidney Care Choices (KCC) ETC Model (the HDPA and PPA), as modifying the regulatory text at Model 155—The KCC Model is an well as a kidney transplant bonus § 512.390(b)(4) of our regulations to optional Innovation Center model for payment under the KCC Model. Kidney clarify that CMS must resolve any nephrologists, dialysis facilities, transplants represent the most desired resulting discrepancy in payment that transplant providers, and other and cost effective treatment for most arises from the application of an providers and suppliers that will be beneficiaries with ESRD, but providers incorrect PPA in a time and manner focused on beneficiaries with CKD and and suppliers may currently have determined by CMS, as opposed to beneficiaries with ESRD. The KCC insufficient financial incentives to assist during the next PPA Period that begins Model is scheduled to begin with an beneficiaries through the transplant after the notification of the ETC implementation period for a portion of process because dialysis generally Participant, as we had proposed. We 2020 and 2021, with the performance results in higher reimbursement over a believe this flexibility will allow CMS to period of the model beginning on April more extended period of time than a more quickly and effectively resolve 1, 2021, and continuing through transplant.157 As a result, we stated that PPA payment discrepancies than the December 31, 2023, with the option for we believed it would be appropriate to more specific time frame described in the Innovation Center to extend the test incentives in both the ETC Model the proposed rule. model by one or two additional and KCC Model simultaneously to performance years.156 Thus, the KCC assess their effects on the transplant 6. Overlap With Other Innovation Model will have up to nearly five years rate. Center Models and CMS Programs of financial accountability overlap with • Comprehensive ESRD Care (CEC) As proposed, the ETC Model would the ETC Model beginning April 1, 2021. Model—The CEC Model is a voluntary overlap with several other CMS We proposed that the types of entities model for ESRD dialysis facilities, programs and models, and we sought eligible to participate in the KCC Model nephrologists, and other providers and comment on our proposals to account as Kidney Care First (KCF) practices and suppliers that focuses on beneficiaries for overlap: Kidney Contracting Entities (KCEs) with ESRD. We noted in the proposed • ESRD Quality Incentive Program would be permitted to participate in the rule that the CEC Model will end on (ESRD QIP)—The ESRD QIP reduces KCC Model within regions where the December 31, 2020, and therefore, payment to a facility under the ESRD ETC Model would be in effect. We would overlap for one year with the PPS for a calendar year by up to 2 stated in the proposed rule that not proposed ETC Model, though the percent if the facility does not meet or allowing these entities to participate as models will now only overlap for three exceed the total performance score KCF practices or KCEs in the KCC months from January 1, 2021 to March established by CMS for the Model within the ETC Model’s Selected 31, 2021 due to the updated timeline for corresponding ESRD QIP payment year Geographic Areas would limit the ETC and CEC Models. We proposed with respect to measures specified for participation in the KCC Model, and that ETC Participants could be selected that payment year. We proposed that the could prevent a sufficient number of from regions where there are ETC Model’s Facility HDPA and Facility KCF practices or KCEs from participants in the CEC Model. Given PPA would be applied prior to the participating in the KCC Model, such the national distribution of CEC ESCOs, application of the ESRD QIP payment that the KCC Model would not have we noted in the proposed rule that we adjustment to the ESRD PPS per sufficient participation to be evaluated. do not believe the overlap between the treatment payment amount, as we were We explained that we believed it was two Models would impact the validity proposing that the Facility HDPA and important to test both models in order of the ETC Model test, as ESCOs would the Facility PPA would adjust the to evaluate payment incentives inside be equally likely to be located in Adjusted ESRD PPS per Treatment Base and outside the coordinated care Selected Geographic Areas as in Rate, as previously discussed in the context. As stated in the proposed rule, Comparison Geographic Areas, creating proposed rule and in section IV.C.4.b of the ETC Model would allow for a a net neutral effect. We also stated that this final rule. broader scope of test due to its we do not believe that the proposed ETC • Merit-based Incentive Payment mandatory nature across half the Model would significantly affect the System (MIPS)—Under section country, while the KCC Model will test CEC Model because the payment 1848(q)(6) of the Act and 42 CFR the effects on outcomes of higher levels incentives under the ETC Model would 414.1405(e), the MIPS payment of risk for a self-selected group of be smaller in 2020 when the CEC Model adjustment factor, and, as applicable, participants. We proposed that payment is active and because the CEC Model is the additional MIPS payment adjustments under the ETC Model focused on total cost of care, the adjustment factor (collectively referred would be counted as expenditures for majority of which is non-dialysis care. to as the MIPS payment adjustment purposes of the KCC Model. We In the proposed rule we noted our belief factors) generally apply to the amount designed both models to include that not allowing CEC ESCOs to otherwise paid under Medicare Part B explicit incentives for participants when participate in the CEC Model within the with respect to covered professional ETC Model’s Selected Geographic Areas services furnished by a MIPS eligible 155 The KCC Model was referred to as the would require either terminating ESCOs clinician during the applicable MIPS Comprehensive Kidney Care Contracting and that participate in the CEC Model in the payment year. We proposed that the Kidney Care First Models in the proposed rule, but has since undergone a rebranding. References in Clinician HDPA and the Clinician PPA this final rule have been updated to reflect the name 157 Abecassis M, Bartlett ST, Collins AJ, Davis CL, in the ETC Model would similarly apply of the model in use as of the date of the publication Delmonico FL, Friedewald JJ et al. Kidney to the amount otherwise paid under of the final rule. transplantation as primary therapy for end-stage Medicare Part B, but would occur prior 156 This timing has been updated from what renal disease: A National Kidney Foundation/ appeared in the proposed rule to reflect the current Kidney Disease Outcomes Quality Initiative (NKF/ to the application of the MIPS payment anticipated timeline for this model as of the date KDOQITM) conference. Clinical Journal of the adjustment factors. This was designed to of publication of this final rule. American Society of Nephrology. 2008;3(2):471–80.

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ETC Model’s Selected Geographic to avoid selection bias and to ensure a considers all Medicare Part A and B Areas, which we believe would broad representation of participants. expenditures, only excluding Inpatient negatively impact the CEC Model test, Concurrent with the ETC Model test, we Medical Education and or altering ETC Model randomization to plan to test the voluntary KCC Model to Disproportionate Share Hospital exclude regions in which CEC ESCOs test the efficacy of coordinated care for payments, while explicitly including are participating in the CEC Model, beneficiaries with advanced kidney individually beneficiary identifiable which we believe would negatively disease. final payments made under a impact the ETC Model by interfering Comment: We received several demonstration, pilot or time limited with the proposed randomization. comments urging CMS to exclude from program when performing financial • All other APMs with Medicare—For the ETC Model beneficiaries aligned to calculations under the program (see, for other Medicare APMs, such as the coordinated care models, particularly example, 42 CFR 425.601(c)(2)). We Medicare Shared Savings Program or the beneficiaries aligned to participants in view the inclusion of payment Next Generation ACO Model, that focus the CEC Model or the KCC Model. adjustments made under the ETC Model on total cost of care, we proposed that Response: We appreciate the as similar to how the payment any increase or decrease in program feedback; however, we believe that adjustments for CMS quality programs, expenditures that is due to the ETC these models are testing different policy like the ESRD QIP, are incorporated into Model would be counted as program questions and that beneficiaries should expenditure calculations under the expenditures to ensure that the be aligned or attributed to participants Medicare Shared Savings Program and Medicare APM continues to measure the in more than one model if such models tested by the Innovation Center total cost of care to the Medicare alignment or attribution is consistent under section 1115A. program. The Medicare Shared Savings with the methodologies for the models. Comment: We received a comment Program regulations include a policy for The CEC and KCC Models are focused urging CMS to adopt quality measures addressing payments under a model, around incentives for managing total around home dialysis and kidney demonstration, or other time-limited cost of care and for managing transplants under the ESRD QIP, rather program. Specifically, in conducting beneficiary care across different than testing the separate ETC Model. payment reconciliation for the Medicare providers, while the ETC Model is Response: CMS is proposing to Shared Savings Program, CMS considers focused specifically on dialysis implement these payment adjustments ‘‘individually beneficiary identifiable modality selection. While both the KCC in the ETC Model rather than the ESRD final payments made under a and ETC Models include financial QIP because it is our intention to apply demonstration, pilot, or time limited incentives around kidney these incentives to Managing Clinicians program’’ (see, for example, transplantation, we believe that the in addition to ESRD facilities. The § 426.610(a)(6)(ii)(B)). In the proposed incentives are different enough in incentives in the ESRD QIP program rule we stated our belief that this structure, including with respect to the apply to ESRD facilities, and not to existing policy sufficiently addresses entity to whom the incentive payments Managing Clinicians, yet CMS believes overlaps that would arise between the are made, that both are worth testing. that Managing Clinicians are a key part Medicare Shared Savings Program and We view this payment overlap between of supporting beneficiary modality the proposed ETC Model. We also stated the ETC Model and the KCC Model as choice and should also face payment that CMS would review any other similar to how an ESRD facility may incentives to increase utilization of models where this form of both participate in the CEC Model and home dialysis and transplants. reconciliation may not be possible and be subject to payment adjustments Additionally, the maximum penalty for make an assessment as to what changes, under the ESRD PPS based on the the ESRD QIP is 2 percent and we if any, may be necessary to account for facility’s performance under the ESRD believe that increasing rates of home the effects of testing the ETC Model. QIP. Additionally, we are concerned dialysis and the inclusion of We invited public comments on our about having a sufficiently large beneficiaries on transplant waitlists are proposals to account for overlaps with beneficiary population to be able to important enough areas to focus on that other CMS programs and models. evaluate the results from the ETC Model ETC Participants should have a larger The following is a summary of the if KCC Participants are excluded and are potential downside and the potential for comments received on overlaps between also concerned about a situation where upside for succeeding in improving the ETC Model and other CMS programs ETC Participants could control whether their rates in these areas. and models, and our responses. a beneficiary is aligned to them under Comment: We received a comment Comment: We received several the ETC Model by taking steps to ensure from a group representing physicians comments urging the Innovation Center that the beneficiary is aligned to an pointing out that Managing Clinicians to test potential methods to increase entity participating in either the CEC who are MIPS eligible clinicians are home dialysis and transplant rates Model or the KCC Model. already subject to MIPS and would be solely through a voluntary model or Comment: We received comments subject to a second set of payment coordinated care framework, rather than urging that any payment adjustments adjustments under the ETC Model. They with the proposed framework of the under the ETC Model be excluded from urged that nephrologist payments only ETC Model. the payment calculations under the be adjusted by MIPS. Response: We appreciate the Medicare Shared Savings Program or Response: The MIPS program was feedback. However, as discussed in under models tested by the Innovation designed to tie payments to quality and section IV.C.3.a of this final rule, we Center under section 1115A of the Act. cost efficient care, drive improvement in believe that both voluntary and Response: We believe that excluding care processes and health outcomes, mandatory frameworks can be used by ETC Model payments from the payment increase the use of healthcare the Innovation Center to test models and calculations under these other information, and reduce the cost of care, can accomplish different goals. As initiatives would compromise the while the ETC Model has a narrower described in the proposed rule and design of these other initiatives, many of focus on kidney replacement modality previously in section IV.C.3.a of this which are focused on accountability for choice. CMS believes that both are final rule, for the ETC Model, we believe the total cost of care. For example, the important focuses for Managing that a mandatory framework is critical Medicare Shared Savings Program Clinicians. Accordingly, CMS believes it

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is appropriate for Managing Clinicians Another commenter asked CMS to requirements of the ESRD QIP for a participating in the ETC Model to have waive back-up arrangement payment year, as may be necessary their payments adjusted under both the requirements for certifications of home solely for purposes of ensuring that the MIPS program and the ETC Model. dialysis providers, and instead allow ESRD QIP payment reduction would be After considering the public licensed home-dialysis providers to applied to ESRD PPS payments that comments, we are finalizing the provide back-up hemodialysis in the have been adjusted by the HDPA and overlaps in policy as proposed without space licensed for home dialysis. CMS the PPA. In addition, we proposed that modification. also received a comment requesting to the payment adjustments made under 7. Medicare Program Waivers include a waiver to permit advanced this Model would not change practice providers under the general beneficiary cost sharing from the regular We noted in the proposed rule our supervision of a Managing Clinician to Medicare program cost sharing for the belief that it was necessary and manage a patient’s home dialysis care. related Part B services that were paid for appropriate to provide additional A commenter urged CMS include beneficiaries who receive services from flexibilities to ETC Participants for waivers necessary to allow renal ETC Participants. We proposed to make purposes of testing the ETC Model. The dieticians to bill for services of nutrition payment adjustments without impacting purpose of such flexibilities would be to education under this Model. According beneficiary cost sharing because, if give ETC Participants additional access to the commenter, nutrition therapy and beneficiary cost sharing changed as a to the tools necessary to ensure ESRD education provided by a renal dietician result of the HDPA and the PPA, this Beneficiaries can select their preferred can improve the patient’s quality of life would create a perverse incentive in treatment modality, resulting in better, and delay the progress of kidney which beneficiaries would pay less to more coordinated care for beneficiaries disease. We received a comment receive services from ETC Participants and improved financial efficiencies for suggesting that CMS issue a waiver to with lower rates of home dialysis and Medicare, providers, suppliers, and allow certified dialysis technicians, transplants, potentially increasing beneficiaries. without the physical presence of a beneficiary interest in receiving care We proposed to implement these licensed nurse, and clinicians providing from providers and suppliers flexibilities using our waiver authority remote monitoring to qualify as performing poorly on the rates the ETC under section 1115A of the Act. Section caregivers who may perform Medicare- Model intends to improve, which would 1115A(d)(1) of the Act provides covered home dialysis. be contrary to the purpose of the Model. authority for the Secretary to waive such Response: We thank all of the Therefore, we proposed to waive the requirements of title XVIII of the Act as commenters for their feedback. The requirements of sections 1833(a), may be necessary solely for purposes of suggested benefit enhancements and 1833(b), 1848(a)(1), 1881(b), and carrying out section 1115A of the Act other waivers were not included in the 1881(h)(1)(A) of the Act to the extent with respect to testing models described proposed rule, and we therefore are not that these requirements otherwise in section 1115A(b) of the Act. This finalizing these benefit enhancements or would apply to payments made under provision affords broad authority for the other waivers suggested by the the ETC Model. We sought comment on Secretary to waive Medicare program commenters in this final rule. CMS will our proposed waivers of Medicare requirements as necessary to test models take the commenters’ feedback into payment requirements related to the under section 1115A of the Act. consideration as we consider potential HDPA and PPA and beneficiary cost The following is a summary of the future changes to the model design. sharing. comments we received suggesting that The following is a summary of the a. Medicare Payment Waivers CMS issue additional waivers and our comments we received on the proposed responses. In order to make the proposed Medicare payment waivers and our Comment: We received many payment adjustments under the ETC responses. comments urging CMS to waive other Model, namely the HDPA and PPA Comment: We received comments requirements. Many commenters discussed in the proposed rule and in supporting our proposal that beneficiary requested CMS to waive requirements sections IV.C.4 and IV.C.5 of this final cost-sharing would be unaffected by the similar to those we have indicated that rule, respectively, we stated in the HDPA and the PPA. we intend to waive for purposes of proposed rule that we believe we would Response: We thank the commenters testing the voluntary KCC Model, such need to waive certain Medicare program for their feedback and support and will as the requirements that will be waived rules. finalize this policy as proposed. for purposes of testing the Concurrent Therefore, in accordance with the Comment: A commenter asked CMS Care for Beneficiaries that Elect the authority granted to the Secretary in to consider including a waiver for Medicare Hospice Benefit Enhancement, section 1115A(d)(1) of the Act, we payment modifications for surgeons, the Home Health Benefit Enhancement, proposed to waive requirements of the hospitals, and surgery centers within Telehealth Benefit Enhancement, and Act for the ESRD PPS and PFS payment the Model to bring reimbursement for Post-Discharge Home Visits Benefit systems only to the extent necessary to PD catheter placement in-line with Enhancement under that Model, as well make these payment adjustments under arteriovenous fistula reimbursement. as requirements we have waived for this proposed payment model for ETC Additionally, the commenter purposes of testing the voluntary Next Participants selected in accordance with recommended adding a PD catheter Generation Accountable Care CMS’s proposed selection methodology. placement diagnosis related group Organization Model, including the Also, we proposed to waive the payment to further incentivize surgeons, waivers necessary for testing the Care requirement in section 1881(h)(1)(A) of hospitals, and surgery centers to Management Home Visits Benefit the Act that payments otherwise made perform this procedure. Enhancement. A commenter also to a provider of services or a renal Response: We thank the commenter specifically requested that CMS waive dialysis facility under the system under for these suggestions. This type of certain telehealth requirements as section 1881(b)(14) of the Act for renal waiver was not included in the necessary to test allowing nurses to dialysis services be reduced by up to 2.0 proposed rule, and we therefore are not provide home dialysis visits via percent if the provider of services or finalizing a waiver of this nature in this telemedicine under the Model. renal dialysis facility does not meet the final rule. Additionally, the

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commenter’s recommendation to add a increase uptake of the benefit.158 We • Under 42 CFR 410.48(d)(1), at least PD catheter placement diagnosis related proposed to waive the requirement that one of the KDE sessions must be group payment is outside the scope of KDE be performed by a physician, PA, dedicated to management of this rulemaking. CMS will take the NP or CNS, to allow additional clinical comorbidities, including delaying the commenter’s other recommendations staff such as dietitians and social need for dialysis. Because we proposed into consideration for future potential workers to furnish the service under the a waiver that would extend the KDE changes to the model design. direction of a Medicare-enrolled benefit to beneficiaries with CKD Stage After considering the public participating Managing Clinician. The V and ESRD in the first 6 months of diagnosis, this KDE topic may no longer comments received, CMS will finalize staff would not need to be Medicare- be relevant to patients who are facing a the Medicare payment waivers, enrolled, but would furnish these more immediate decision to commence including our policy with respect to services incident to the services of a dialysis or arrange for a kidney beneficiary cost-sharing, as proposed clinician authorized to bill Medicare for transplant. We proposed to waive the without modification in our regulation KDE services as specified in section requirement that KDE include the topic at 42 CFR 512.397(a). 1861(ggg)(2)(B)(i). In the proposed rule, we considered also waiving the of managing comorbidities and delaying b. Waiver of Select KDE Benefit requirement under section the need for dialysis under the ETC Requirements 1861(ggg)(2)(B) of the Act and the Model, when furnishing KDE to implementing regulation at 42 CFR beneficiaries with CKD Stage V and We stated in the proposed rule our 410.48(c)(2)(ii) restricting ESRD ESRD. We proposed further clarifying, belief that it is necessary for purposes of facilities from billing for KDE directly, however, that ETC Participants who are testing the ETC Model to waive select but decided not to, as we did not believe Managing Clinicians furnishing KDE requirements of the KDE benefit it is necessary for testing the Model. (either personally or with clinical staff authorized in section 1861(ggg)(1) of the Moreover, ESRD facilities are already incident to their services) must still Act and in the implementing regulation required to provide information to cover this topic if relevant to the at 42 CFR 410.48. Medicare currently beneficiaries about their treatment beneficiary, for example, if the covers up to 6, 1-hour sessions of KDE modality options in the ESRD facility beneficiary has not yet started dialysis services for beneficiaries that have Stage conditions for coverage at § 494.70(a)(7); and can still benefit from education IV CKD. While the KDE benefit is and to develop and implement a plan of regarding delaying dialysis. designed to educate and inform care that addresses the patient’s • Under 42 CFR 410.48(d)(5)(iii), an beneficiaries about the effects of kidney modality of care, at § 494.90(a)(7). outcomes assessment designed to disease, their options for measure beneficiary knowledge about • KDE is now covered only for transplantation, dialysis modalities, and CKD and its treatment must be Medicare beneficiaries with Stage IV vascular access, the uptake of this performed by a qualified clinician CKD as required by section service has been low at less than 2 during one of the 6 sessions. This 1861(ggg)(1)(A) of the Act and in the percent of eligible patients. As noted in requirement presents two challenges; implementing regulations at 42 CFR the proposed rule, we believe that the first that it may take away time from a 410.48(b)(1). As we noted in the KDE benefit is one of the best tools to session that could be dedicated proposed rule, we understood this promote treatment modalities other than exclusively to education, and second prevents many beneficiaries in Stage V in-center HD and that this waiver is that if a beneficiary demonstrates of CKD from receiving the benefits of necessary to test ways to increase its inadequate knowledge, there may not be KDE before starting dialysis or pursuing utilization from its current low rate as sufficient time in one session to address a transplant. In the proposed rule, we part of the model test. all areas in which a beneficiary might hypothesized that beneficiaries with need assistance. If the outcomes We proposed to waive the following ESRD could also benefit from this assessment could be performed by requirements for ETC Participants education in the first 6 months after an qualified staff during a follow-up visit to billing for KDE services: ESRD diagnosis. While CKD Stage V and the Managing Clinician, there would • early ESRD patients’ disease may be Currently, doctors, physician still be 6 full KDE sessions available to more advanced and the prospect of assistants (PAs), nurse practitioners beneficiaries, and we believe there dialysis or transplant more certain than (NPs), and clinical nurse specialists would be more flexibility for the for patients with Stage IV CKD, there is (CNSs) are the only clinician types that qualified staff to reinforce what the still opportunity to improve beneficiary can furnish and bill for KDE services as beneficiary learned during the KDE knowledge to ensure the best patient- required by section 1861(ggg)(2)(A)(i) of sessions and fill in any gaps. We centered care and outcomes. GAO the Act and its implementing regulation proposed to maintain the requirement recommended covering the KDE benefit at 42 CFR 410.48(a) and 42 CFR that an outcomes assessment be for beneficiaries with Stage V CKD.159 410.48(c)(2)(i). However, the payment performed by qualified staff in some We proposed to waive the requirement for KDE is lower than a typical manner within one month of the final that KDE is covered only for Stage 4 evaluation and management (E/M) visit, KDE session, but to waive the CKD patients for purposes of testing the so there may be limited financial requirement that it be conducted within ETC Model and to permit beneficiaries incentive for these clinician types to a KDE session. with CKD Stage V and those in the first conduct the KDE sessions. There are In the proposed rule, we also various other types of health care 6 months of receiving an ESRD diagnosis to receive the benefit, when considered waiving the co-insurance providers that also may be well-suited requirement for the KDE benefit and to educate beneficiaries about kidney billed by an ETC Participant who is a Managing Clinician. certain telehealth requirements to allow disease, such as registered dieticians the KDE benefit to be delivered via and nephrology nurses. In its 2015 telehealth for beneficiaries outside of 158 United States Government Accountability report on home dialysis, GAO rural areas and other applicable recommended allowing other types of Office, 2015. 159 United States Government Accountability limitations on telehealth originating health care providers to perform KDE to Office, 2015. sites, but did not believe those waivers

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were necessary for purposes of testing and can still benefit from education public sectors, CMS is not permitted to the Model. regarding delaying dialysis. endorse any particular product. The following is a summary of the Comment: We received comments After considering the public comments received on the proposed urging CMS to waive additional comments, we are finalizing the waivers of select requirements of the categories of beneficiary cost sharing in proposed waivers of select requirements KDE benefit for purposes of testing the this Model, including cost-sharing for of the KDE Benefit for purposes of ETC Model and the alternatives the KDE benefit or home-dialysis testing the ETC Model, with changes, in considered and our responses. treatments. our regulation at § 512.397(b). Comment: We received several Response: We thank the commenters Specifically, we will waive the comments, supporting CMS’ proposal to for their feedback. While we considered requirement that only doctors, waive select requirements of the KDE waiving the coinsurance for the KDE physician assistants, nurse practitioners, Benefit for the purposes of testing the benefit, the ETC Model aims to test the and clinical nurse specialists can ETC Model. However, many use of financial incentives for ETC furnish KDE services to allow KDE commenters asked CMS to further Participants (namely Managing services to be provided by clinical staff increase the scope of the KDE benefit Clinicians and ESRD facilities), rather under the direction of and incident to under the proposed waivers, specifically than beneficiary incentives, and we are the services of the Managing Clinician in order to allow additional clinicians concerned that testing a financial who is an ETC Participant. Our and health care sites provide the KDE incentive for ETC Participants in regulation at § 512.397(b) will now list benefit, including dieticians, social conjunction with additional behavioral the Supplier and Non-Physician workers, ambulance providers, home incentives for beneficiaries could Practitioner types that will be able to health aides, and other clinicians who confound the Model test. Specifically, it furnish and bill for the KDE benefit work in nursing homes or ESRD would be difficult to determine whether facilities. Additionally, a commenter the impacts observed in the Model are under this waiver. This list does not asked CMS not to increase the scope of a result of the Model’s financial exclude any supplier types that would the KDE benefit to dialysis provider incentives or beneficiary incentives. otherwise have been permitted to staff, while another requested that CMS Additionally, CMS is concerned that furnish the KDE benefit. Specifically, issue additional waivers in order to including waivers for additional the waiver will allow the KDE benefit to provide more flexibility around the categories of beneficiary cost-sharing be furnished and billed by a physician, timeframe within which the KDE benefit could influence beneficiaries to choose as well as a clinical nurse specialist, could be provided. Finally, a health care providers based on the lower licensed clinical social worker, nurse commenter expressed concern that the cost of treatment, rather than the quality practitioner, physician assistant, KDE Benefit would permit health care of care that the health care providers registered dietician/nutrition providers to give beneficiaries deliver. CMS will take the commenters’ professional, and supplier specialty incomplete information. recommendations into consideration for listed as clinic/group practice to test Response: We appreciate the future potential changes to the model greater use of the KDE benefit. We also commenters’ support for our proposals design. will waive the requirement that KDE is to waive select requirements of the KDE Comment: We received one comment covered only for Stage 4 CKD patients benefit for purposes of testing the ETC asking CMS to change payment for KDE to permit beneficiaries with CKD Stage Model. While we understand the to ‘‘per treatment-hour reimbursement’’ V and those in the first 6 months of commenter’s interest in increasing even to incentivize ESRD facilities to educate starting dialysis to receive the KDE further the types of clinicians and patients as early as possible for benefit. In the proposed rule, we stated entities that may provide the KDE transition to home dialysis. The that we would waive this requirement to benefit, we believe that our proposed commenter also suggested that ‘‘highly permit beneficiaries with CKD Stage V policy provides the necessary flexibility skilled, 24/7 centralized real-time and those in the first 6 months of an to test the Model and will finalize the equipment and clinical telephone ESRD diagnosis to receive the KDE types of clinicians and entities that may support’’ must be in place after patients benefit. However, we have since provide the KDE benefit as proposed. begin dialyzing at home. determined that using ESRD diagnosis We also understand the commenter’s Response: We thank the commenter codes to identify beneficiaries in the concern that the proposed waivers of for this feedback. We did not propose to first 6 months of an ESRD diagnosis in certain KDE Benefit requirements would change payment for the KDE benefit in order to determine eligibility for the allow health care providers to give the proposed rule, nor did we propose KDE benefit would be difficult to beneficiaries less information than is to require that ‘‘highly skilled, 24/7 operationalize due to the potential for currently required. However, we centralized real-time equipment and delays in reporting of the diagnosis, as proposed to waive the requirement to clinical telephone support’’ be in place well as incomplete reporting of include managing comorbidities and after patients begin dialyzing at home, diagnosis codes on Medicare claims. By delaying the need for dialysis as a and we therefore are not finalizing these contrast, CMS can use Medicare claims required topic as part of a KDE session policies in this final rule. CMS will take data to more quickly and accurately because those topics may not be the commenter’s recommendations into identify ESRD Beneficiaries based on relevant to beneficiaries with CKD Stage consideration for future potential the submission of claims for the V and ESRD, who will be able to receive changes to the model design. initiation of dialysis, which is the KDE Benefit under the ETC Model. Comment: A commenter consistent with how Medicare FFS We also will finalize our proposed recommended the commenter’s identifies ESRD Beneficiaries generally. clarification that ETC Participants who proprietary tool for patient education We are therefore modifying our are Managing Clinicians furnishing KDE programs for home dialysis and asked regulation at 512.397(b)(2) to permit (either personally or with clinical staff CMS to require ETC Participants to use KDE services to be furnished to incident to their services) must still this tool in all educational programs beneficiaries in the first 6 months of cover this topic if relevant to the related to home dialysis. starting dialysis (rather than the first 6 beneficiary, for example, if the Response: While we encourage months of receiving an ESRD diagnosis). beneficiary has not yet started dialysis innovation in both the private and Therefore, in the final rule, we will

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waive this requirement to permit Monetary Penalty to provide ETC proposed rule that we believed this beneficiaries with CKD Stage IV, CKD Participants with the flexibilities found policy is necessary to help ensure that Stage V, and those in the first 6 months in other models tested under the beneficiary modality selection is based of dialysis to receive the KDE benefit. authority of section 1115A of the Act. on the care of the beneficiary and the Also, as we noted in the preamble to the Commenters asserted that these fraud beneficiary’s needs and preferences, proposed rule, we clarify that this and abuse waivers are necessary to rather than financial or other incentives waiver applies only when claims for improve care coordination, population the beneficiary may have received or such services are billed by an ETC health management, patient education been offered. Participant who is a Managing on home dialysis, and post-transplant Furthermore, we explained in the Clinician. We will also waive the care. proposed rule, beneficiaries with requirement that the content of the KDE Response: We appreciate the disabilities who receive care from ETC sessions include the topic of managing commenters’ interest in this matter. Participants, including dementia and comorbidities and delaying the need for However, as we stated in the proposed cognitive impairments, remain dialysis under the ETC Model, when rule (84 FR 34563), no fraud and abuse protected under Federal disability rights such services are furnished to waivers are being issued for this Model. laws including, but not limited to, beneficiaries with CKD Stage V or At this time, we believe that the section 504 of the Rehabilitation Act of ESRD. However, we will require that arrangements contemplated by this 1973, the Americans with Disabilities ETC Participants who are Managing Model can be executed in a manner that Act of 1990, as amended, and section Clinicians furnishing KDE (either complies with existing fraud and abuse 1557 of the Patient Protection and personally or with clinical staff incident laws and that fraud and abuse waivers Affordable Care Act. These beneficiaries to their services) must still cover this are not necessary to test this Model. cannot be denied access to home topic if relevant to the beneficiary, for Thus, notwithstanding any other dialysis or kidney transplant due to example, if the beneficiary has not yet provisions of this final regulation, all their disability. We stated that ETC started dialysis and can still benefit ETC Participants must comply with all Participants may not apply eligibility from education regarding delaying applicable laws and regulations. criteria for participation in programs, activities, and services that screen out or dialysis. As proposed, we will waive the 9. Beneficiary Protections requirement that an outcomes tend to screen out individuals with assessment designed to measure As we discussed in the proposed rule disabilities; nor may ETC Participants beneficiary knowledge about CKD and and in section IV.C.4.b of this final rule, provide services or benefits to its treatment be performed by qualified we proposed to attribute non-excluded individuals with disabilities through staff as part of one of the KDE sessions, ESRD Beneficiaries and, as applicable, programs that are separate or different, provided that such outcomes pre-emptive transplant beneficiaries to excepting those separate programs that assessment is performed in some the ETC Participant that furnishes the are necessary to ensure that the benefits manner within one month of the final plurality of the beneficiary’s dialysis and services are equally effective. KDE session by qualified staff. and other ESRD-related services. In addition, as described in the Although the ETC Model would not proposed rule and in sections IV.C.4.c 8. Compliance With Fraud and Abuse allow ESRD Beneficiaries to opt out of and IV.C.5.e.(2) of this final rule, we Laws the payment adjustment methodology proposed to apply the Clinician HDPA The authority for the ETC Model is being applied to the Medicare payments and the Clinician PPA to the amount section 1115A of the Act. Under section made for their care, the Model would otherwise paid under Medicare Part B 1115A(d)(1) of the Act, the Secretary of not affect beneficiaries’ freedom to and furnished by the Managing Health and Human Services may waive choose their dialysis services provider Clinician during the CY subject to such requirements of Titles XI and XVIII or supplier, meaning that beneficiaries adjustment, which would mean that and of sections 1902(a)(1), 1902(a)(13), may elect to see any Medicare-enrolled beneficiary cost sharing would not be 1903(m)(2)(A)(iii), and certain provider or supplier including those affected by the application of the provisions of section 1934 as may be selected and not selected to participate Clinician HDPA and the Clinician PPA. necessary solely for purposes of carrying in the Model based on geography. In Similarly, as described in the proposed out section 1115A with respect to addition, the general beneficiary rule and section IV.C.7.a. of this final testing models described in section protections described in the proposed rule, we proposed to use our waiver 1115A(b). For this Model and consistent rule and section II.B.2.a.(8) of this final authority under section 1115A(d)(1) of with this standard, the Secretary may rule would apply to the ETC Model; the Act to issue certain payment consider issuing waivers of certain fraud accordingly, ETC Participants would be waivers, pursuant to which beneficiaries and abuse provisions in sections 1128A, prohibited from restricting beneficiary would be held harmless from any 1128B, and 1877 of the SSA. However, freedom of choice or access to medically model-specific payment adjustments CMS proposed that no fraud and abuse necessary covered services, which made to Medicare payments under this waivers would be issued for this Model. includes the beneficiary’s choice Model. Thus, notwithstanding any other regarding the appropriate modality to We proposed to specify in our provision of this final regulation, all receive covered services. ETC regulations at § 512.330(a) that ETC ETC Participants must comply with all Participants also would be prohibited Participants would be required to applicable laws and regulations. from using or distributing descriptive prominently display informational The following is a summary of the model materials and activities that are materials in each of their offices or comments received on compliance with materially inaccurate or misleading. We facility locations where beneficiaries fraud and abuse laws and our responses. proposed to prohibit ETC Participants receive treatment to notify beneficiaries Comment: We received several from offering or paying any that the ETC Participant is participating requests from commenters to include remuneration to influence a in the ETC Model. This notification waivers of the physician self-referral beneficiary’s choice of renal would serve to inform a beneficiary that law (commonly referred to as the ‘‘Stark replacement modality, unless such his or her provider or supplier is law’’), Federal Anti-Kickback Statute, remuneration complied with all participating in a model that and the Beneficiary Inducements Civil applicable law. We stated in the incentivizes the use of home dialysis

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and kidney transplants and who to other treatment modalities besides home performance in the ETC Model. We contact if they have questions or dialysis or transplant despite adequate address comments related to beneficiary concerns. As we stated in the proposed education on treatment choices. exclusions under section IV.C.B.1 of this rule, we proposed this notification to Accordingly, a commenter suggested final rule. Beneficiaries are not Model further non-speculative government adding in a quality measure for participants and while they cannot opt interests including transparency and physician-patient relationship and the out of the ETC Model’s payment beneficiary freedom of choice. So as not shared decision making process. methodology, attributed beneficiaries to be unduly burdensome, we stated in Response: CMS appreciates the retain all existing beneficiary rights and the proposed rule that CMS intends to feedback to include additional protections regarding Medicare Parts A provide a template for these materials to provisions regarding patient choice in and B services, including choice of ETC Participants, which would identify the design of the model, but believes providers, suppliers and treatment required content that the ETC patient choice is adequately protected in modality. Participant must not change and places the provision to be finalized in our Comment: We received one comment where the ETC Participant may insert its regulation at § 512.120. As applied to requesting that we create an Alternative own original content. This template the ETC Model, this provision prohibits Payment Models Beneficiary would include information for ETC Participants from inhibiting a Ombudsman to cast a wide net for beneficiaries about how to contact the beneficiary’s freedom to choose the beneficiary issues. ESRD Network Organizations with any provider and supplier from which they Response: We disagree that a questions or concerns regarding receive care. The ETC Model would not Beneficiary Ombudsman is necessary participation in the ETC Model by their restrict beneficiaries from choosing in- for the testing of the ETC Model. As health care provider(s). (The 18 ESRD center dialysis as their treatment choice. previously noted, beneficiaries are not Network Organizations serve distinct We are, however, making certain Model participants and while they geographical regions and operate under modifications to our proposed cannot opt out of the ETC Model’s contract to CMS; their responsibilities beneficiary notification requirements in payment methodology, attributed include oversight of the quality of care light of the comments received. As beneficiaries retain all existing to ESRD Beneficiaries, the collection of proposed, each ETC Participant will be beneficiary rights and protections data to administer the national Medicare required to prominently display regarding Medicare Parts A and B ESRD program, and the provision of informational materials in each of their services, including choice of providers, technical assistance to ESRD providers office or facility locations where suppliers and treatment modality. In and patients in areas related to ESRD). beneficiaries receive treatment to notify addition, as described elsewhere in this We noted in the proposed rule that all beneficiaries that the ETC Participant is final rule, we plan to conduct the other ETC Participant communications participating in the ETC Model. Also as monitoring activities described in our with beneficiaries that are descriptive proposed, CMS will provide a template regulation at § 512.150 to determine model materials and activities would be for these materials, which will include whether the Model is resulting in subject to the requirements for such information for beneficiaries about how unintended consequences, including materials and activities included in the to contact the ESRD Network impact on beneficiary choice. We thank general provisions, as discussed in the Organizations with any questions or the commenter for this feedback and are proposed rule and section II.D.3 of this concerns regarding participation in the finalizing the rule without the addition final rule. ETC Model by their health care of a Beneficiary Ombudsman. The following is a summary of the provider(s). To promote CMS’s interest Comment: We received two comments comments received on the proposed in ensuring that beneficiaries are not in support of the beneficiary protection beneficiary protections and our mislead into believing that the Model in provisions identified in § 512.120 of the responses. any way restricts their freedom of proposed rule and their application to Comment: We received multiple choice, the CMS-provided template for the ETC Model. Multiple commenters comments expressing concern that the the beneficiary notification materials appreciated CMS proposals to protect structure and incentives of the Model will also include an affirmation of a beneficiaries’ freedom to choose could produce unintended beneficiary’s protections under services providers and suppliers by consequences that would be contrary to Medicare, including the freedom to applying the general beneficiary beneficiary freedom of choice and choose his or her provider or supplier protection provisions identified in access to medically necessary covered and to select the treatment modality of § 512.120 to the ETC Model and the services. Many commenters stressed his or her choice. We have revised our proposed requirement for ETC that the criteria for ESRD Beneficiaries regulation at § 512.330(a) to specify that Participants to notify beneficiaries of to be excluded from attribution to ETC the CMS-provided template for the such participation under proposed Participants under the ETC Model, beneficiary notification will include, § 512.330(a). described in § 512.360(b) of the without limitation, this information. Response: We thank the commenters regulatory text, should include an Additionally, ETC Participants must for their feedback and support. exclusion for patient treatment choice. continue to make medically necessary Comment: A commenter Additionally, a commenter covered services available to recommended that beneficiaries be recommended that beneficiaries be beneficiaries and cannot target or avoid provided optional assistance in allowed to opt of out the Model. The treating beneficiaries on the basis of transferring to a provider or supplier not rationale for these suggestions was that their income levels or other factors that participating in the ETC Model without patients could choose other treatment would render a beneficiary an at-risk undue hardship, including assistance modalities or supportive care due to beneficiary as that term is defined for with any transportation barriers. Some religious reasons, patients’ need or purposes of the Medicare Shared commenters asked for beneficiaries to desire to travel for work or leisure, or Savings Program, and similarly may not have the ability to formally indicate reliance on inpatient facilities due to selectively target or engage beneficiaries they are not interested in home dialysis other confounding co-morbidities or who are relatively healthy or otherwise or kidney transplantation and, as a factors. Several commenters expected to improve the ETC result, to be excluded from the home acknowledged that patients may choose Participant’s financial or quality dialysis rate and transplant rate

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calculations for purposes of the ETC about all available coverage options and notification that the ETC Participant is Model. disclose relevant information about participating in the ETC Model; Response: We disagree with these payments to patients and insurers. instructions on how to contact the ESRD recommendations and will finalize the Response: We disagree that Network Organizations with any rule without this modification. Nothing beneficiary notifications beyond those questions or concerns about the ETC in this final rule prohibits a practice identified in §§ 512.330 and 512.120 of Participant’s participation in the Model; from offering beneficiaries the optional the final rule are necessary for the and an affirmation of the ESRD assistance described by the commenter, testing of this Model. As noted in the beneficiary’s protections under as long as the assistance complies with proposed rule and elsewhere in this Medicare, including the beneficiary’s all applicable laws and regulations, final rule, beneficiaries will retain all freedom to choose his or her provider or including the Federal anti-kickback existing beneficiary rights and supplier and to select the treatment statute and the civil monetary penalty protections regarding Medicare Parts A modality of his or her choice. provision prohibiting inducements to and B services, including choice of beneficiaries. To the extent the providers, suppliers, and treatment 10. Monitoring commenter is advocating that the modality. a. Monitoring Activities Secretary waive one or more laws After considering the public We proposed that the general pursuant to section 1115A(d)(1) of the comments, we are finalizing the provisions relating to monitoring Act to enable the provision of proposed beneficiary notification described in the proposed rule and in transportation or other assistance, we requirements in our regulation at section II.I of this final rule would apply note that the statutory standard for § 512.330 with modification. In to ETC Participants, including but not issuance of such a waiver would not be § 512.330(b) of the final rule, we are limited to cooperating with the model satisfied because we have determined making a change to the applicability of monitoring activities under § 512.150, that offering transportation or other our regulation at § 512.120(c) (regarding granting the government the right to assistance to beneficiaries is not descriptive model materials and necessary to test the ETC Model. The activities) to the CMS-provided audit under § 512.135(a), and retaining Model would not affect beneficiaries’ templates for the informational and providing access to records under freedom to choose their dialysis services materials required to be displayed in the §§ 512.135(c) and 512.135(b), provider or supplier, meaning that office or facilities of ETC Participants respectively. CMS would conduct the beneficiaries may elect to see any where beneficiaries receive treatment model monitoring activities in Medicare-enrolled provider or supplier described in our regulation at accordance with the proposed including those selected and not § 512.330(a). In the proposed rule, we § 512.150. We stated in the proposed selected to participate in the Model had proposed that the entirety of rule that we believed that we must based on geography. We decline to § 512.120(c) would not apply to such closely monitor the implementation and modify the Model terms to permit CMS-provided materials. However, this outcomes of the ETC Model throughout beneficiaries to opt out of the Model was a drafting error. We had intended its duration. As described in the payment adjustment methodology being to refer only to the requirement in proposed rule, the purpose of applied to the Medicare payments made 512.120(c)(2), such that the requirement monitoring would be to ensure that the for their care because their attribution to include the disclaimer that ‘‘The Model is implemented safely and and inclusion are necessary to statements contained in this document appropriately; that ETC Participants determine if Model payment are solely those of the authors and do comply with all the terms and adjustments can achieve the Model’s not necessarily reflect the views or conditions of the ETC Model; and to goals of increasing rates of home policies of the Centers for Medicare & protect beneficiaries from potential dialysis utilization and kidney Medicaid Services (CMS). The authors harms that may result from the activities transplantation and, as a result, assume responsibility for the accuracy of an ETC Participant. All monitoring improving or maintaining the quality of and completeness of the information activities under the ETC Model would care while reducing Medicare contained in this document’’ would not focus exclusively on Medicare FFS expenditures among all types of ESRD apply to those CMS-provided materials. beneficiaries. facilities and for a full representation of Because the purpose of these materials Consistent with proposed § 512.150, beneficiaries receiving services at those is to educate beneficiaries about the we proposed that monitoring activities ESRD facilities. In addition, while Model and because our regulation at may include documentation requests payment adjustments to the Managing § 512.330(a) will permit an ETC sent to the ETC Participant; audits of Clinicians and ESRD facilities are being Participant to insert its own original claims data, quality measures, medical tested under the Model, the health care content to the CMS-provided templates, records, and other data from the ETC services available to Beneficiaries likely where indicated by CMS, we believe Participant; interviews with members of will not change since the Beneficiary that it is important that the other the staff and leadership of the ETC will retain their existing Medicare right requirements of § 512.120(c) apply to Participant; interviews with to choose their providers and suppliers, those materials, including the beneficiaries and their caregivers; site as identified in § 512.120 of the final requirement that such materials not be visits to the ETC Participant; monitoring rule. The notification required under materially inaccurate or misleading, that quality outcomes and clinical data; and § 512.330 will also include an ETC Participants retain copies of such tracking patient complaints and appeals. affirmation of the ESRD Beneficiary’s materials, and that CMS reserve the Specific to the ETC Model, we would protections under Medicare, including right to review such materials to use the most recent claims data the beneficiary’s freedom to choose his determine whether the content added by available to track utilization of certain or her provider or supplier and to select the ETC Participant is materially types of treatments, beneficiary the treatment modality of his or her inaccurate or misleading. Also, we have hospitalization and Emergency choice. revised § 512.330(a) of our regulations to Department use, and beneficiary referral Comment: A commenter specify that the CMS-provided template patterns to make sure the utilization and recommended that we require ETC for the beneficiary notification will beneficiary outcomes are in line with Participants to inform beneficiaries include, without limitation, a the Model’s intent. We stated in the

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proposed rule that we believe this type analytic efforts and may require longer- groups and closely monitor patient of monitoring is important because as term study. We stated in the proposed surveys to uncover any of the ETC Participants adapt to new payment rule that we believe it is important to unintended consequences listed earlier incentives, we want to ensure to the monitor the transplant and home or others that may be unforeseen. We greatest extent possible that the Model dialysis trends over a longer period of noted in the proposed rule that we is effective and Medicare beneficiaries time to make sure the incentives are not believe beneficiary and/or care partner continue to receive high quality, low adversely affecting the population of feedback would be a tremendous asset cost, and medically appropriate care. beneficiaries included in the Model. to help CMS determine and resolve any In the proposed rule, we recognized We also stated in the proposed rule issues directly affecting beneficiaries. that one of the likely outcomes of this that we would examine the extent of In addition, we sought comment on Model would be an increase in any unintended consequences, how the payment adjustments under the utilization of home dialysis. However, including any increase in adverse ETC Model may influence delivery- in testing payment incentives aimed at clinical events such as graft failures, oriented interventions among increasing utilization of this modality, returns to dialysis, peritonitis and other participating ESRD facilities and there may be a risk of inappropriate health incidents due to home dialysis, Managing Clinicians (for example, steering of ESRD Beneficiaries who are fluctuations in machine and supplies increased Managing Clinician unsuitable for home dialysis. As markets, lemon-dropping clinically knowledge of dialysis modalities, described in the proposed rule and complex patients, cherry-picking of less greater patient education, increased section IV.C.5.b.(1) of this final rule, we clinically complex patients, increase in investment in equipment and supplies), proposed to exclude from beneficiary referrals to home dialysis for patients as well as how the Model’s financial attribution certain categories of that are not physically or cognitively incentives may affect the resourcing of beneficiaries not well suited to home able to safely handle the responsibility these endeavors, and what are the dialysis, including beneficiaries with a of dialyzing at home, or an increase in barriers to change. The following is a diagnosis of dementia. We proposed referrals to Comparison Geographic summary of the comments received on these eligibility criteria to exclude Areas. Specifically, we would monitor monitoring and our responses. certain categories of beneficiaries from the rate at which back-up in-center Comment: We received multiple attribution up front so Managing dialysis (Claim Code 76) and ESRD self- comments expressing support for our Clinicians and ESRD facilities that are care retraining (Claim Code 87) are used proposed monitoring plan for the ETC ETC Participants do not attempt or for home dialysis beneficiaries. The use Model. believe that it is wise to attempt to place of back-up dialysis for a home dialysis Response: We thank the commenters these particular beneficiaries on home beneficiary can also be an indicator of for their support and are finalizing this dialysis. In addition, we proposed that equipment malfunction. Under the monitoring policy for the ETC Model CMS would monitor for inappropriate Innovation Center’s authority in 42 CFR without modification. encouragement or recommendations for 403.1110, and built upon in our Comment: We received multiple home dialysis through the proposed regulation at § 512.130, we would seek comments recommending additional monitoring activities. We stated in the to obtain clinical data for home dialysis events and conditions for monitoring proposed rule that instances of patients such as an increase in instances under the ETC Model. A commenter inappropriate home dialysis would of fever, abnormal bleeding, access recommended that we monitor for show up through increases in patient point issues, and changes in vitals or frequent hospitalizations, patient non- hospitalization, infection, or incidence weight, from ETC Participants for compliance and non-adherence, of peritonitis. For example, multiple monitoring purposes and also would tracheotomy, patients who have a incidences of peritonitis would be a use applicable Medicare claims data. catheter in certain cases, acute blood good indicator that the patient should In the proposed rule, we welcomed loss due to surgical intervention, not be on PD. If claims data show input about how to best track issues unknown acute blood loss including unusual patterns, we proposed to with home dialysis equipment and gastrointestinal bleeds, heart failure review a sample of medical records for machines and the format of any exacerbation, endocarditis, stroke, indicators that a beneficiary was not proposed documentation for any sepsis, septic shock, surgical procedures suited for home dialysis. In the incidents that occur, and how CMS (for example, heart surgery, proposed rule, we discussed using should share any information about amputations, etc.), active malignancies, patient surveys and interviews to look incidents that occur. diabetic ketoacidosis, Methicillin- for instances of coercion on beneficiary For those beneficiaries attributed to resistant Staphylococcus aureus choice of modality against beneficiary ETC Participants who have received a (MRSA), Methicillin-susceptible wishes. If such instances of coercion kidney transplant, we proposed to Staphylococcus aureus (MSSA), ulcers were found, we stated that we would monitor transplant registry data from (for example, decubitus or foot ulcers), take one or more remedial action(s) as the SRTR, Medicare claims data open wounds (for example, bed sores), described at § 512.160 against the ETC available for life of transplant, post- abscess (stump or other diabetic-related Participant and refer the case to CMS for transplant rates of hospitalization and abscess), peri-anal abscess, further investigation and/or remedial ED visits, infection and rejection rates, osteomyelitis, bowel perforation, action. and cost of care compared to the cardiac arrest, cellulitis, leg and hip Additionally, we noted in the beneficiaries who have received a fractures, cholecystitis, ulcerative proposed rule that we would employ kidney transplant and are not included colitis, substance abuse, active lupus, longer-term analytic strategies to in the ETC Model test. active Polycystic Kidney Disease (PKD), confirm our ongoing analyses and detect We stated in the proposed rule that a behavioral problems, especially those more subtle or hard-to-determine key pillar of our monitoring strategy for associated with mental illness changes in care delivery and beneficiary both transplant, pre-emptive transplant diagnosis, bariatric issues, especially outcomes. Some determinations of and home dialysis beneficiaries would those patients with weighing in excess beneficiary outcomes or changes in be stakeholder engagement, and we of 500 lbs., and chronic hypertension treatment delivery patterns may not be would continue conversations and related to cardiac disease such as able to be built into ongoing claims relationships with patient-advocate cardiomyopathy. Another commenter

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recommended that we look for blood beneficiary choice and medical information made available through stream infections for beneficiaries appropriateness. claims data. receiving HHD and peritonitis for Comment: A commenter After consideration of the public beneficiaries receiving PD. Another recommended that we consider whether comments, we are finalizing the commenter recommended that we monitoring could be accomplished monitoring policy for the ETC Model as monitor for resource shifting between through an existing network or survey proposed, without modification. rather than a separate, model-specific the Comparison Geographic Areas and b. Quality Measures Selected Geographic Areas, lemon- monitoring process and, in the dropping and cherry-picking patients alternative, requested clarification on In addition to the monitoring who are more likely to receive a how the ETC Model monitoring process activities discussed previously, we transplant, market exits and reduction would align with existing monitoring proposed two ESRD facility quality processes. measures for the ETC Model: of in-center chairs in small and low- • volume facilities serving a critical need, Response: As noted in the proposed Standardized Mortality Ratio rates of peritonitis, bloodstream rule and previously in this final rule, (SMR); NQF #0369—Risk-adjusted infections in home HD patients, and the ETC Model is aimed at increasing standardized mortality ratio of the attrition from home dialysis. utilization of home dialysis and thus number of observed deaths to the Response: We thank the commenters may create a risk of inappropriate number of expected deaths for patients steering ESRD Beneficiaries who are at the ESRD facility. for their feedback, which will be • informative and helpful as we further unsuitable for home dialysis. This Standardized Hospitalization Ratio develop our monitoring strategy for the unique risk created under this Model (SHR); NQF #1463—Risk-adjusted ETC Model. We note that requires model-specific monitoring standardized hospitalization ratio of the hospitalizations, infections and activities, in addition to the existing number of observed hospitalizations to peritonitis were identified in the CMS monitoring processes to protect the number of expected hospitalizations preamble to the proposed rule as items ESRD Beneficiaries. We thank the for patients at the ESRD facility. for monitoring and we intend to monitor commenter for the feedback and are We explained in the proposed rule for these events under the ETC Model. finalizing our proposed monitoring that SMR and SHR measures are Comment: A commenter expressed strategy without modification. currently calculated and displayed on concern that the monitoring approach Comment: A commenter expressed Dialysis Facility Compare, a public described in the proposed rule is too concern that peritonitis is not included reporting tool maintained by CMS. The vague and requested that CMS provide in hospital acquired infection reporting SHR is also included in the ESRD QIP additional information on our plans to and is not accounted for in hospital measure set as a clinical measure on monitor for beneficiary choice and payment, and asked that facilities that which ESRD facilities’ performance is medical appropriateness under the accept PD patients and place PD scored.160 Because data collection and Model. catheters be accountable for clinical measure reporting are ongoing, there Response: We thank the commenter competency and infections. would be no additional burden to ETC for the feedback and are finalizing our Response: We thank the commenter Participants to report data on these monitoring policy for the ETC Model for this feedback and note this specific measures for the ETC Model. We stated without modification. We disagree with item is beyond the scope of this in the proposed rule that, although CMS the comment that our monitoring policy rulemaking. The ETC Model, as has in a previous rule acknowledged for the ETC Model is too vague. In the described in the final rule, would not concerns that the SMR might not be proposed rule, we provided a list of change or modify hospital quality adequately risk adjusted (78 FR 72208), monitoring activities we would plan to reporting or payment methodology to we believe this measure is appropriate implement in the ETC Model. We account for incidences of peritonitis that for purposes of the ETC Model, under identified a number of areas of ETC occur in their facility or otherwise. which the SMR would not be used for Model-specific risk and provided Comment: A commenter expressed purposes of determining payment. specific examples of data, concern that our proposed monitoring Mortality is a key health care outcome documentation and activities that we plan would be too retrospective and used to assess quality of care in different would monitor to address that risk. would not identify issues quickly settings. We noted in the proposed rule Within a broad outline of monitoring enough. The commenter cited the that while we recognize that the ESRD activities described in the regulatory timing for the availability of claims data population is inherently at high risk for text and preamble of the final rule, we as an example. In addition, the mortality, we believe that mortality rates will retain discretion and flexibility as commenter expressed concern that are susceptible to the quality of care to the specific risks, subject matter, certain risks are difficult or impossible provided by dialysis facilities, and note timing, items to be reviewed and to identify through claims data, that the measure is currently being used mechanics of our monitoring strategy including peritonitis and partner in the CEC Model. The SMR is NQF and activities during the model test to burnout. endorsed, indicating that it serves as a be responsive and devote resources to Response: We thank the commenter reliable and valid measure of mortality areas of high priority as they become for the feedback. However, we note that among ESRD Beneficiaries who receive identified. In the proposed rule, we also in addition to reviewing claims data, we dialysis at ESRD facilities. identified that we may review medical also may review medical records and We stated in the proposed rule that records and clinical data, perform clinical data, perform interviews with we considered including the In-Center interviews with beneficiaries, beneficiaries, caregivers, and ETC Hemodialysis (ICH) CAHPS® survey to caregivers, and ETC Participant Participant leadership and staff, monitor beneficiary perceptions of leadership and staff, implement surveys, implement surveys, review complaints review complaints and appeals, and and appeals, and engage with 160 For the specifications for these measures, see engage with stakeholders and including stakeholders including patient advocacy ‘‘CMS ESRD Measures Manual for the 2018 Performance Period/2020 Payment Year’’, June 20, patient advocacy groups. We believe groups. We believe these monitoring 2018, https://www.cms.gov/Medicare/Quality- these activities will support our strategies will provide us timely Initiatives-Patient-Assessment-Instruments/ monitoring for restrictions on feedback and will supplement the ESRDQIP/Downloads/ESRD-Manual-v30.pdf.

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changes in quality of care as a result of Participant would be captured in these consequence of performance-based the ETC Model. However, the ICH measures. These measures also include payment adjustments for home dialysis CAHPS survey includes only ESRD Beneficiaries before they receive a and transplant. While there are beneficiaries who receive in-center kidney transplant; however, currently no measures of adverse events dialysis. The survey specifically beneficiaries post-transplant would not for beneficiaries who dialyze at home, excludes the two beneficiary be included, per the measure CMS believes that adverse events at populations that the ETC Model would specifications. ESRD facilities is a suitable proxy, as focus on, namely beneficiaries who We invited public comment on the the measures include both beneficiaries dialyze at home and beneficiaries who proposed quality measures and whether who dialyze at home and beneficiaries receive transplants and, therefore, we their proposed use would enable CMS who dialyze in-center for a given ESRD did not propose to use this measure for to sufficiently monitor for adverse facility. purposes of the ETC Model. conditions for ESRD Beneficiaries, in Comment: We received several We noted in the proposed rule that we combination with the monitoring comments emphasizing the importance considered including quality measures activities previously described. We also of beneficiary experience and requesting for Managing Clinicians that are invited other suggestions as to measures that CMS include a formal measure of reported by Managing Clinicians for that would support monitoring beneficiary experience in this Model. A MIPS or other CMS programs. However, beneficiary health and safety under the couple comments suggested that CMS whereas all ESRD facilities are subject to Model, while minimizing provider develop a CAHPS measure for home the same set of quality measures under burden. dialysis. the ESRD QIP, there is no analogous Additionally, as described in the Response: CMS considered the source of quality measure data for proposed rule and in section IV.C.6 of inclusion of ICH CAHPS to monitor Managing Clinicians. We stated that this final rule, we proposed that ETC beneficiary perceptions of change in Managing Clinicians may be subject to Participants that are ESRD facilities quality of care as a result of the ETC MIPS, or they may be participating in a would still be included in the ESRD QIP Model. However, as we stated in the different CMS program—or an and required to comply with that proposed rule, because the ICH CAHPS Advanced APM—which has different program’s requirements, including being survey includes only beneficiaries who quality requirements. In addition, most subject to a sliding scale payment receive in-center dialysis, and Managing Clinicians participating in reduction if an ESRD facility’s total specifically excludes the beneficiary MIPS select the quality measures on performance score does not meet or populations that this Model is which they report. Taken together, these exceed the minimum total performance specifically focused on, namely factors mean that we would be unable score specified by CMS for the payment beneficiaries moving away from in- to ensure that all Managing Clinicians in year. We explained that ETC center hemodialysis to alternative renal the ETC Model are already reporting on Participants who are Managing replacement therapies, ICH CAHPS does a given quality measure, and therefore Clinicians and are MIPS eligible not reach the target beneficiary would be unable to compare quality clinicians would still be subject to MIPS population. Because there is no performance across all Managing requirements and payment adjustment equivalent CAHPS or other survey for Clinicians without imposing additional factors, and those in a MIPS APM would home dialysis patients, or for post- burden. be scored using the APM scoring transplant patients, CMS intends to We proposed that the SHR and SMR standard. ETC Participants who are develop a beneficiary experience measures would not be tied to payment Managing Clinicians and who are in an measure, similar to the CAHPS survey, under the ETC Model. However, we Advanced APM would still be assessed that could influence Model payments to stated in the proposed rule that we to determine whether they are participants as early as the third year of believe that the collection and Qualifying APM Participants (QPs) who, the Model. We intend to propose and monitoring of these measures would be as such, would earn the APM incentive incorporate a beneficiary experience important to guard against adverse payment and would not be subject to measure in the ETC Model in the near events or decreases in quality of care the MIPS reporting requirements or future. that may occur as a result of the payment adjustment. We did not The Model’s evaluation will examine performance-based payment propose to waive any of these the effect of the ETC Model on such key adjustments in the ETC Model. We requirements for purposes of testing the outcomes as improved quality of care noted that we believe we would be able ETC Model. and quality of life. Data collection to observe changes over time in The following is a summary of the activities performed for purposes of the individual ESRD facility level scores on comments received on the quality evaluation may include patient surveys these measures, as well as comparing measures included in the Model and our and beneficiary focus groups. change over time for ESRD facilities that responses. Comment: Multiple commenters are ETC Participants against change over Comment: CMS received supportive encouraged CMS to add additional time in those that are not ETC comments for our proposal to use the quality measures. The commenters Participants. In the aggregate, these two quality measures and not tie them suggested measures including: ED measures should capture any increase in to payment. However, a commenter utilization; peritonitis in hospital adverse events, particularly for patients stated that the measures incentivize acquired infections; provision of on home dialysis, as home dialysis increase utilization rather than supportive care services; behavioral and patients are included in both the performance improvement. mental health; care coordination; safety numerators and denominators of these Response: CMS appreciates the and reliability; provider engagement; measures. We stated in the proposed feedback from these commenters. Both and Advanced Care Plans. In addition, rule that home dialysis patients the SMR and the SHR are NQF-endorsed commenters recommended that CMS primarily receive care through ESRD outcome measures for patients who develop a measure for referrals into the facilities, and barring beneficiaries receive dialysis at a given ESRD facility. transplantation process as well as excluded from the measures per the The measures were chosen for the hospice. A commenter noted the burden measure specifications, the majority of purpose of monitoring for adverse of manual data collection and the ESRD Beneficiaries attributed to an ETC events that may occur as an unintended impact on patient care.

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Response: CMS chose the SMR and statistical properties of the ratios. The implementation component of the SHR measures, essential indicators for Additionally, the measures are being evaluation would describe and assess the ESRD population, because they are used in the Model for monitoring how ETC Participants implement the already reported in Dialysis Facility purposes, and are not intended to Model, including barriers to and Reports and the ESRD QIP, respectively. convey specific information about facilitators of change. We noted in the These are programs run by CMS/CCSQ individual facility performance to the proposed rule that findings from both that produce dialysis facility-level public. the impact analysis and the quality data annually and, therefore, Comment: A commenter requested implementation assessment would be impose no additional administrative that CMS acknowledge that palliative synthesized to provide insight into what burden on ESRD facilities. We dialysis is a patient-preference option worked and why, and to inform the appreciate commenters suggestions that should not result in penalties under Secretary’s potential decision regarding about other potential quality measures the ESRD QIP. model expansion. that we could include in the ETC Model Response: CMS appreciates the We would use multi-pronged data that may benefit the patient population. feedback from our stakeholders. collection efforts to gather the However, we believe that the two However, the comment pertains to the quantitative and qualitative data needed quality measures we have included are ESRD QIP generally and is therefore not to understand the context of the Model sufficient for the purposes of monitoring within the scope of this final rule. implemented at participating ESRD to guard against adverse events or Based on the comments received, we facility and Managing Clinician decreases in quality of care that may are finalizing the quality measures as locations and the perspectives of occur as a result of the performance- proposed without modification. different stakeholders. Data for the based payment adjustments in the 11. Evaluation analyses would come from sources Model. All ETC Participants remain including, but not limited to, payment subject to other applicable CMS quality As we described in the proposed rule, and performance data files, programs unless otherwise exempt, so an evaluation of the ETC Model would administrative transplant registry data, we believe that other potential aspects be conducted in accordance with beneficiary focus groups, and interviews of quality of care are sufficiently section 1115A(b)(4) of the Act, which with ETC Participants. captured and incentivized by those requires the Secretary to evaluate each As described in the proposed rule, the quality programs. In addition, the model tested by the Innovation Center. quantitative impact analysis would purpose of the measures is solely for We noted in the proposed rule that we compare performance and outcome monitoring for adverse events that may believe an independent evaluation of measures over time, using a difference- occur as an unintended consequence of the Model is necessary to understand its in-differences or a similar approach to performance-based payment impacts of the Model on quality of care compare beneficiaries treated by ETC adjustments for home dialysis and and Medicare program expenditures and Participants to those treated by ESRD transplant, and will have no impact on to share with the public. We would facilities and Managing Clinicians in the payment adjustments under the ETC select an independent evaluation Comparison Geographic Areas. We Model. Therefore, CMS believes these contractor to perform this evaluation. As would examine both cumulative and two measures are adequate and no specified in the proposed rule and year-over-year impacts. The quantitative additional measures are needed at this section II.E of this final rule, all ETC analyses conducted for the evaluation time. Participants would be required to would take advantage of the mandatory Comment: CMS received one cooperate with the evaluation. nature of the ETC Model for ESRD comment urging CMS to use mortality We stated in the proposed rule that facilities and Managing Clinicians and hospitalization rates rather than research questions addressed in the located in Selected Geographic Areas. ratios because ratio measures have wide evaluation would include, but not be We explained in the proposed rule confidence intervals that potentially limited to, whether or not the ETC that, while the model design would lead to incorrect information about Model results in a higher rate of control for the selection bias inherent in facility performance being reported. In transplantation and home dialysis, voluntary models, a comparison group addition, the commenter recommended better quality of care and quality of life, would still be necessary to determine if that CMS work with NQF to develop and reduced utilization and any changes in outcomes are due to the social-demographic adjusters. expenditures for ESRD Beneficiaries in ETC Model or to secular trends in CKD Response: CMS appreciates the Selected Geographic Areas in relation to and ESRD care. The comparison group feedback. Both of the proposed Comparison Geographic Areas. The would be those Managing Clinicians measures are NQF-endorsed measures evaluation would also explore and ESRD facilities located in for renal conditions and are already qualitatively what changes Managing Comparison Geographic Areas which reported through CMS reporting Clinicians and ESRD facilities would not be subject to the ETC Model systems, Dialysis Facility Compare for implemented in response to the ETC payment adjustments. The evaluator SHR and SMR, and ESRD QIP for SHR. Model, what challenges they faced, and would match Managing Clinicians and We believe it is appropriate to use the lessons learned to inform future policy ESRD facilities located in Comparison ratio measures for the purposes of the developments. Geographic Areas with Managing Model because they align with existing We proposed that the ETC Model Clinicians and ESRD facilities that are CMS programs. Additionally, we do not evaluation would employ a mixed- located in Selected Geographic Areas believe that the statistical features of methods approach using quantitative (that is, ETC Participants) using these ratio measures referenced, namely and qualitative data to measure both the propensity scores or other accepted the wide confidence intervals, impact of the Model and statistical techniques. Beneficiaries who contributes to incorrect information implementation effectiveness. The receive care from ESRD facilities and about facility performance being impact analysis would examine the Managing Clinicians in these Selected reported. These measures are already effect of the ETC Model on key Geographic Areas and Comparison reported publicly at the facility level outcomes, including improved quality Geographic Areas would be identified through Dialysis Facility Compare and of care and quality of life, and decreased using the ETC Model claims-based the ESRD QIP, with explanation of the Medicare expenditures and utilization. eligibility criteria, and would be

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attributed using the same claims-based of life, and we will analyze these help implement the learning system and beneficiary attribution methods we questions to the extent feasible. branding the learning collaborative as proposed to use for purposes of Comment: Several commenters the ‘‘Transplant First’’ initiative. calculating the MPS. expressed concern that 50 percent of the Another commenter proposed delaying We stated in the proposed rule that 306 HRRs in the US is larger than is implementation of the transplant the evaluation would account for any necessary to evaluate a change in the component of the PPA until the learning interaction with other CKD- and ESRD- transplantation rate as a result of the collaborative has been implemented for related initiatives at CMS, such as the Model. multiple years. ESRD QIP, the CEC Model, and the KCC Response: As previously noted, we performed a power calculation to Response: We appreciate the Model (formerly the CKC Model). For commenters’ support for the proposed example, the evaluator would look for determine the minimum sample size of learning system and are finalizing our disparate outcomes that could arise in the participant and comparison groups proposal to implement it as proposed. the ESRD QIP between facilities that are in the Model in order to produce robust We plan to refer to the learning system also participating in the ETC Model and and reliable results. We determined as the ETC Learning Collaborative as it facilities that are not participating in the from these tests that 30 percent of the is a part of the ETC Model test and we ETC Model and also assess whether HRRs are needed to minimize the risk performance in the ETC Model varies of false positive and false negative do not wish to confuse ETC Participants for Managing Clinicians and ESRD results, and the minimum detectable or the public by giving the learning Facilities who are also participating in effect of a two percentage point increase system a name with no clear connection the CEC or KCC Models. or decrease in the rate of transplant wait to the Model. We appreciate the We invited public comment on our listing and a one and one-half suggestion about the QIOs, but we do proposed approach related to the percentage point increase or decrease in not believe that QIO involvement is evaluation of the ETC Model. home dialysis Since this approach necessary given their other priority provides sufficient statistical power, we Comment: A commenter noted that areas that they are working on. In terms are finalizing our evaluation approach CMS did not specify the timing of the of the comment recommending that as proposed. ETC Model evaluation. CMS delay implementation of the Response: We thank the commenter 12. Learning System transplant component of the PPA until the learning collaborative has been for this feedback. The evaluation will be We proposed that in conjunction with active during and after the Model test implemented for multiple years, while the ETC Model, CMS would operate a we hope that the ETC Learning period to allow for data collection and voluntary learning system focused on Collaborative will be successful at analysis. We expect the evaluation will increasing the availability of deceased improving utilization of available have annual reports covering the donor kidneys for transplantation. The kidneys, such a delay is not necessary assessment of the Model using available learning system would work with, data, including a summative report regularly convene, and support ETC because, as previously described in following the conclusion of the model Participants and other stakeholders section IV.C of this final rule, we are test. required for successful kidney now assessing ESRD facilities and Comment: A commenter transplantation, such as transplant Managing Clinicians based on their recommended that the evaluation take centers, OPOs, and large donor ability to impact transplant rates into account any possible negative hospitals. We proposed that these ETC calculated as the sum of the transplant impacts or lack of impact of the Model. Participants and stakeholders would waitlist rate and the living donor Should the latter occur, the commenter utilize learning and quality transplant rate, rather than overall suggested that the Model should be improvement techniques to transplant rates including deceased terminated. systematically spread the best practices donor transplants, for purposes of the Response: We agree with the of highest performers. The application ESRD PPA and Managing Clinician commenter regarding the need to assess of broad scale learning and other PPA, respectively. potential negative impacts of the Model. mechanisms for rapid and effective After considering the public We clarify here that the evaluation will transfer of knowledge within a learning comments, we are implementing the account for potential impacts of the network would also be used. Quality learning system under this Model as Model including positive, negative, or a improvement approaches would be proposed. lack thereof, in terms of both Medicare employed to improve performance by expenditures and the quality of care and collecting and analyzing data to identify 13. Remedial Action we would determine the appropriate the highest performers, and to help As described in the proposed rule and actions, including potential termination others to test, adapt and spread the best in section 512.160 of this final rule, the of the Model, based upon an analysis of practices of these high performers remedial actions outlined in the general the evaluation findings. throughout the entire national organ provisions in § 512.160 would apply to Comment: A commenter noted that recovery system. We stated in the the ETC Model. Accordingly, if CMS the Model evaluation should measure proposed rule that we believed that determines that an ETC Participant has the impact of concurrent hospice implementation of the learning system engaged in one or more of the actions dialysis access; specifically, patient and would help to increase the supply of listed under § 512.160(a) (Grounds for family experience with care satisfaction transplantable kidneys, which would Remedial Action), CMS may take one or and costs at the end of life. help ETC Participants achieve the goals more of the remedial actions listed Response: We appreciate this of the Model. comment suggesting a measure to assess Comment: We received several under § 512.160(b). in evaluating the Model. The Model comments in this area, all supporting We did not receive comments on our evaluation’s questions around quality of CMS’s proposal to implement the proposals relating to remedial action in care and quality of life and expenditures proposed learning system. A commenter the ETC Model. Therefore, we are include questions regarding patient and proposed working with the Quality finalizing these proposals without family experience and costs at the end Improvement Organizations (QIOs) to modification.

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14. Termination of the ETC Model There are site-of-service payment countries indicate a population with As described in the proposed rule, the differentials between the OPPS and PFS poor clinical outcomes and potentially general provisions relating to payment systems, which can result in avoidable expenditures. We anticipate termination of the Model that CMS financial incentives to offer care in one preservation or improvement in quality proposed in the proposed rule and setting over another. Second, as in other of care for beneficiaries and reduced discussed in section II.J of this final rule health care settings, health care expenditures under the ETC Model would apply to the ETC Model. providers are financially incentivized to inasmuch as the Model will create Consistent with these provisions, in the provide more services to patients incentives for beneficiaries, along with event we terminate the ETC Model, we because they are paid based on the their families and caregivers, to choose would provide written notice to ETC volume of care they provide, not value. the optimal kidney replacement Participants specifying the grounds for We believe that these incentives are modality. In section IV.B of this final rule, we termination and the effective date of misaligned with evidence-based describe how current Medicare payment such termination or ending. As practice, which is moving toward furnishing fewer radiation treatments rules and a deficit in beneficiary provided by section 1115A(d)(2) of the for certain cancer types. Third, education result in a bias toward in- Act and § 512.170, termination of the difficulties in coding and setting center hemodialysis, which is often not Model under section 1115A(b)(3)(B) of payment rates for RT services have led preferred by patients or physicians the Act would not be subject to to volatility in Medicare payment for relative to home dialysis or kidney administrative or judicial review. transplantation. We provide evidence We did not receive comments on the these services under the PFS and from published literature to support the proposals relating to termination of the increased coding complexity and projection that higher rates of home ETC Model. Therefore, we are finalizing administrative burden. As part of the RO Model’s design, we will examine dialysis and kidney transplants will our proposals without modification. whether the model leads to higher reduce Medicare expenditures, and, not V. Collection of Information quality care by encouraging improved only enhance beneficiary choice, Requirements adherence to clinical guidelines and by independence, and quality of life, but As stated in section 1115A(d)(3) of the collecting information related to quality also preserve or enhance the quality of Act, Chapter 35 of title 44, United States performance and clinical practice. The care for ESRD beneficiaries. As described in detail in sections II. Code, shall not apply to the testing, RO Model aims to incentivize RO and IV. of this final rule, ETC evaluation, and expansion of models participants to maintain high quality Participants will be subject to payment under section 1115A of the Act. As a care with the opportunity to earn back adjustments under the ESRD result, the information collection a withheld payment amount through Prospective Payment System (ESRD requirements contained in this final rule successful quality outcomes and clinical PPS) and Physician Fee Schedule (PFS), need not be reviewed by the Office of data reporting. As described in detail in section as applicable, and will be required to Management and Budget. However, we III.C.8. of this final rule, RO participants comply with certain requirements, have summarized the anticipated are required to collect and submit data including to cooperate with CMS’s information collection requirements in on quality measures, clinical data, and monitoring and evaluation activities, for section VI.C.4. of this final rule. patient experience throughout the the duration of the ETC Model. VI. Regulatory Impact Analysis course of the RO Model, beginning 3. Impact of RO Model and ETC Model January 1, 2021, with the final data We have examined the impact of this In the proposed rule (84 FR 34567), final rule as required by Executive submission ending in 2026. We refer readers to section III.B. of we estimated, as detailed in Table 16A Order 12866 and other laws and of the proposed rule, a net impact of Executive Orders, requiring economic this final rule for more information on our research and rationale for the RO $260 million in net savings to the analysis of the effects of final rules. A Model, including summaries of Medicare program due to the RO Model regulatory impact analysis (RIA) must stakeholder comments on this rationale from January 1, 2020 through December be prepared for major rules with and our response. We refer readers to 31, 2024, with a range of impacts economically significant effects ($100 section III.C for more information on between $50 million and $460 million million or more in any 1 year). We policy-related stakeholder comments, in net Medicare savings. Alternatively, estimate that this rulemaking is our responses to those comments, and as detailed in Table 16B of the proposed ‘‘economically significant’’ as measured statements of final policy. rule, we estimated a net impact of $250 by the $100 million threshold and also million in net savings to the Medicare a major rule under the Congressional 2. Need for End-Stage Renal Disease program due to the RO Model from Review Act. Accordingly, we have (ESRD) Treatment Choices (ETC) Model April 1, 2020 through December 31, prepared a RIA that, to the best of our Beneficiaries with ESRD are among 2024, with a range of impacts between ability, reflects the economic impact of the most medically fragile and high-cost $40 million and $450 million in net the policies contained in this final rule. populations served by the Medicare Medicare savings. A. Statement of Need program. One of CMS’ goals in As detailed in Table 17 of the designing the ETC Model is to test ways proposed rule, we estimated the 1. Need for the Radiation Oncology (RO) to incentivize home dialysis and kidney Medicare program would save a net Model transplants, so as to enhance beneficiary total of $185 million from the PPA and Radiotherapy (RT) services represent choice of modality for renal replacement HDPA, which would be applied under a promising area of health care for therapy, and improve or maintain the ETC Model between January 1, 2020 payment and service delivery reform. quality of care while reducing Medicare through June 30, 2026. We also stated First, RT services are furnished in both program expenditures. The substantially our expectation that the ETC Model freestanding radiation therapy centers higher expenditures, mortality, and would cost an additional $15 million, paid under the Medicare Physician Fee hospitalization rates for dialysis patients resulting from increases in education Schedule (PFS) and the Outpatient in the U.S. compared to those for and training costs. Therefore, we Prospective Payment System (OPPS). individuals with ESRD in other estimated the net impact to Medicare

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spending to be $169 million in savings B. Overall Impact and design of the model strongly as a result of the ETC Model. We have examined the impacts of this influence the extent to which the We solicited comment on the final rule as required by Executive evaluation will be able to accurately assumptions and analysis presented Order 12866 on Regulatory Planning assess the effect of a given model test throughout the regulatory impact and Review (September 30, 1993), and produce clear and replicable section of the proposed rule. Executive Order 13563 on Improving results. Comment: A few commenters stated Regulation and Regulatory Review The Innovation Center conducts that the RO Model’s estimates of $250- (January 18, 2011), the Regulatory analyses to determine the ideal number $260 million in savings over a 5-year Flexibility Act (RFA) (September 19, of participants for each model for period are understated. One commenter 1980, Pub. L. 96–354), section 1102(b) of evaluation purposes. This analysis suggested that total savings would be the Social Security Act, section 202 of considers a variety of factors including closer to $320 million over 5 years the Unfunded Mandates Reform Act of the target population (for example, based on volume and intensity (V&I) 1995 (March 22, 1995; Pub. L. 104–4), Medicare beneficiaries with select calculations of the bundled services per Executive Order 13132 on Federalism medical conditions), model eligibility episode, which remain unchanged (August 4, 1999), the Congressional (for example, beneficiary eligibility between the period used for rate setting Review Act (5 U.S.C. 804(2)), and criteria for inclusion in the model), and when payments are made. Executive Order 13771 on Reducing participant enrollment strategy (for Response: We thank these Regulation and Controlling Regulatory example, mandatory versus voluntary) commenters for expressing their Costs (January 30, 2017). and, the need to test effects on concerns. Policy impact estimates may Executive Orders 12866 and 13563 subgroups. Model size can also be vary depending on a number of factors. direct agencies to assess all costs and influenced by the type and size of Our estimate reflects a net Medicare Part benefits of available regulatory hypothesized effect on beneficiary B financial impact. Therefore, our alternatives and, if regulation is outcomes, such as quality of care, or the impact analysis includes changes to necessary, to select regulatory target level of model savings. The Medicare Trust Fund payments and approaches that maximize net benefits smaller the expected impact a model is other Medicare financing interaction (including potential economic, hypothesized to achieve, the larger a effects such as changes in Part B Trust environmental, public health and safety model needs to be for CMS to have Fund revenue, MA capitation rates, effects, distributive impacts, and confidence in the observed impacts. APM incentive payments, and the BBA equity). Section 3(f) of Executive Order An insufficient number of 1999 IPPS Part A deductible cap. 12866 defines a ‘‘significant regulatory participants increases the risk that the Moreover, the impact estimate excluded action’’ as an action that is likely to evaluation will be imprecise in changes in beneficiary cost sharing result in a rule: (1) Having an annual detecting the true effect of a model, liability to the extent it is not shifted to effect on the economy of $100 million potentially leading, for example, to a being a Federal outlay by the policy. or more in any one year, or adversely false negative or false positive result. Our estimate also assumed the V&I of and materially affecting a sector of the The goal is to design a model that is the bundled services per episode economy, productivity, competition, sufficiently large to achieve adequate remains unchanged between the period jobs, the environment, public health or precision but not so large as to waste used for rate setting and when payments safety, or state, local or tribal CMS’s limited resources. These are made. We estimated that if V&I were governments or communities (also decisions affect the quality of evidence to decrease by 1.0 percent annually for referred to as ‘‘economically CMS is able to present regarding the the bundled services absent the model, significant’’); (2) creating a serious impacts of a model on quality of care, then Medicare would reduce net outlays inconsistency or otherwise interfering utilization, and spending. by $50 million ($40 million with an April 1, 2020 start date) between 2020 with an action taken or planned by a. Radiation Oncology (RO) Model and 2024. Similarly, if V&I increases by another agency; (3) materially altering In the case of the RO Model, in the 1.0 percent annually then net outlays the budgetary impacts of entitlement proposed rule we determined the would be reduced by $460 million ($450 grants, user fees, or loan programs or the sample size necessary for a minimum million with an April 1, 2020 start date) rights and obligations of recipients estimated savings impact of 3 percent for the projection period. While we thereof; or (4) raising novel legal or (84 FR 34568). While a savings higher noted in the proposed rule that although policy issues arising out of legal than 3 percent would require a smaller V&I growth from 2014 through 2017 fell mandates, the President’s priorities, or sample size from an evaluation within this 1.0 percent range and did the principles set forth in the Executive perspective, if we were to reduce the not exhibit a secular trend, actual Order. As stated previously in this final size of the RO Model and if the actual experiences may vary. We are finalizing rule, this final rule triggers these savings are at or just below the 3 percent a different Model performance period criteria. level, then we would increase the risk and Model geographic scope than C. Anticipated Effects of being unable to detect whether the proposed, and have updated RO Model resulted in savings. assumptions and estimates in VI.C of 1. Scale of the Model We refer readers to the proposed rule this final rule. As we stated in the proposed rule (84 where we proposed that the RO Model Based on the finalized policy, we FR 34569 through 34570), there is no would include 40 percent of radiation have updated our net estimate of the RO one-size-fits-all approach to designing, oncology episodes in eligible geographic Model impact and now expect a savings implementing, and evaluating models. areas and our simulation based on this of $230 million for Medicare. We have Each payment and service delivery proposal. In section III.C.3.c of this final also updated our net estimate of the ETC model tested by the Innovation Center is rule, we finalized our policy to include Model impact and now expect a savings unique in its goals, and thus its design. 30 percent of radiation oncology of $23 million for Medicare. We discuss Models vary in size in order to episodes and a low-volume exception. our analysis in greater detail in sections accommodate various design features We performed a simulation based on VI.C.1(a) and VI.C.2.a(3) of this final and satisfy a variety of priorities. our finalized policies. Based on this rule. Decisions made regarding the features simulation, we expect to have

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approximately 500 physician group c. Aggregate Effects on the Market payment for RT services furnished to practices (PGPs) (of which 275 are As we noted in the proposed rule, Medicare beneficiaries during episodes freestanding radiation therapy centers) there may be spillover effects in the initiated between January 1, 2021 and and 450 HOPDs furnishing RT services non-Medicare market, or in non-ESRD December 31, 2025. in those simulated selected CBSAs. We areas of the Medicare market because of The RO Model will test differences in further expect the RO Model to include the implementation of these models. payment from traditional FFS Medicare approximately 348,000 episodes, Testing changes in Medicare payment by paying RO participants two equal 309,000 beneficiaries, and $5.3 billion policy may have implications for non- lump-sum payments, once at the start of in total episode spending of allowed Medicare payers. As an example, non- the RO episode and again at the end, for charges over the Model performance Medicare patients may benefit if episodes of care. RO episode means the period. To determine the number of participating providers and suppliers 90-day period that, as set forth in PGPs, we counted the number of TINs introduce system-wide changes that § 512.245, begins on the date of service that furnished at least one professional improve the coordination and quality of that a Professional participant or a Dual or technical component in 2018 in one health care. Other payers may also be participant furnishes an initial of the CBSAs selected for Model developing payment models and may treatment planning service to an RO participation as recorded in the 2016– align their payment structures with beneficiary in a freestanding radiation 2018 episode file. To determine the CMS or may be waiting to utilize results therapy center or an HOPD, provided number of HOPDs, we counted the from CMS’ evaluations of payment that a Technical participant or the same number of facility CCNs that furnished models. Because there is uncertainty Dual participant furnishes a technical at least one technical component in whether and how this evidence applies component RT service to the RO 2018 in the CBSAs selected for Model to a test of these new payment models, beneficiary within 28 days of such RT participation as recorded in the 2016– our analyses assume that spillover treatment planning service. RO episodes 2018 episode file. Similarly, to effects on non-Medicare payers will not include all Medicare items and services determine episode count, beneficiary occur, although this assumption is described in § 512.235 that are count, and total spending estimates, we subject to considerable uncertainty. We furnished to an RO beneficiary drew upon the historical data of RO solicited comments on this assumption described in § 512.215. Once an RO participants simulated into CBSAs and evidence on how this rulemaking episode is initiated, RO participants will selected for participation. These would impact non-Medicare payers and no longer be allowed to separately bill estimates represent the Model size of 30 patients. other HCPCS codes or APC codes for percent of RO episodes in eligible Comment: A couple of commenters activities related to radiation treatment geographic areas expressed concern that the RO Model for the RO beneficiary in that RO b. End-Stage Renal Disease (ESRD) payment methodology could the impact episode. Treatment Choices (ETC) Model practices where commercial payers use For each participating entity, the Medicare rates as a proxy. participant-specific professional episode The ETC Model will include Response: As stated in the proposed approximately 30 percent of ESRD payment and participant-specific rule for the RO Model (84 FR 34568), technical episode payment amounts beneficiaries, through the ESRD although we assume that spillover facilities and Managing Clinicians would be determined as described in effects on non-Medicare payers will not detail in section III.C.6. of this final rule. selected for participation in the Model. occur, we understand that considerable The Innovation Center will randomly The RO Model is not a total cost of uncertainty surrounds this assumption. care model. RO participants will still select 30 percent of HRRs, stratified by However, no evidence has been found to region, and include separate from bill traditional FFS Medicare for support this assumption that that the services not included in the episode randomization all HRRs for which at RO Model will impact non-Medicare payment and, in some instances, for less least 20 percent of the component zip payers either. In our analyses, we common cancers not included in the codes are located in Maryland. All assume growth of FFS Medicare Part B model and other exclusion criteria. A ESRD facilities and Managing Clinicians enrollment as projected in the 2018 list of cancer types that meet the criteria in selected HRRs, referred to as Selected Medicare Trustees Report. We also for inclusion in the RO Model and Geographic Areas, will be required to assume that providers and suppliers associated FFS procedure codes are participate in the Model. There are would not change payer mix as a included in section III.C.5. of this final currently 7,196 ESRD facilities and response to the RO Model. However, we rule. 2,286 Managing Clinicians enrolled in hope that, at the end of the RO Model’s Medicare, distributed across 306 HRRs evaluation, information learned can (2) Data and Methods and providing care for 383,057 ESRD move Medicare and non-Medicare Similar to the analysis performed for beneficiaries that meet the eligibility payment to more accurately and regulatory impact analysis for the criteria for attribution to ETC appropriately reimburse high-value RT Participants under the Model. Only services. proposed rule (84 FR 34571), a approximately 10 percent of stochastic simulation based on the beneficiaries on dialysis received home 2. Effects on the Medicare Program finalized policies was created to dialysis in 2017. The ETC Model will a. Radiation Oncology Model estimate the financial impacts of the RO apply the payment adjustments Model relative to baseline expenditures. described in section IV. of this final rule (1) Overview The simulation relied upon statistical to claims with ‘‘claim service dates’’ Under the current FFS payment assumptions derived from between January 1, 2021 through June system, RT services are paid on a per retrospectively constructed RT episodes 30, 2027, and over that time period, will service basis to both PGPs (including between 2016 and 2018 (updated from randomize 30 percent of the HRRs that freestanding radiation therapy centers) the 2015–2017 episodes used in the the ESRD facilities and Managing and HOPDs through the PFS and the proposed rule to reflect finalized Clinicians align with and generate $23 OPPS, respectively. The RO Model will policy). This information was reviewed million in net Medicare savings. See be a mandatory model designed to test and determined to be reasonable for the Table 2 for an annual breakdown. a prospectively determined episode estimates.

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To project baseline expenditures, On net, we project a lower spending technical episode payment amounts and traditional FFS payment system billing reduction per RO episode and that that APM incentive payments will be patterns are assumed to continue under slightly more RO episodes (2,000 more paid based on participation in the RO current law. Forecasts of the Medicare RO episodes) would be paid through the Model during 2021 and 2022. Due to the Part A and Part B deductibles were RO Model. As for the stop-loss policy, 2-year lag between the QPP performance obtained from the 2019 Medicare it applies only to RO participants with and payment periods, these APM Trustees Report and applied to fewer than 60 episodes during 2016– incentive payments are therefore simulated episode payments to estimate 2018 and were furnishing included RT assumed to be made during 2023 and interactions of lump sum payments with services in the CBSAs selected for 2024. the HOPD line item cap as described in participation at the time of the effective Complete information regarding the section 1833(t)(8)(C)(i) of the Act. We date of this final rule. Under the stop- data sources and underlying assumed that the current relative value loss policy, if payments under the methodology used to determine units under the PFS and relative Model resulted in more than 20 percent amounts for reconciliation were not payment weights under the OPPS in the loss as compared to the amount the RO available at the time of this forecast. In updated episode data from 2016 through participant would have received under the case of the incomplete payment 2018 would continue into the future, FFS, then CMS owes the RO participant withhold, we assumed CMS retains which is consistent with the updates we the amount that exceeds that 20 percent. payment only in the event that offsetting made for the payment methodology in Recall that RO participants with fewer payment errors were made elsewhere. section III.C.6 of this final rule. than 60 episodes during 2016–2018 do Past CMS experience in other value- Similarly, conversion factors in both the not receive a historical experience based payment initiatives that included PFS and OPPS were indexed to the adjustment. The stop-loss payments for a penalty for not reporting have shown appropriate update factors under these RO participants were projected high rates of reporting compliance. current law. Payment rate updates to under the assumption that similar Given the limited spending being future PFS conversion factors are qualification rates and FFS claims withheld, scoring criteria, and specified legislated at 0.25 percent in 2019 and volatility for these eligible providers timeframes involved, we assume that 0.0 percent for 2020 through 2025 under experienced during 2016–2018 would quality and patient experience the Medicare Access and CHIP occur within no-pay claims submitted withholds, on net, have a negligible Reauthorization Act of 2015. OPPS during the Model test. The RO financial impact to CMS. conversion factors are updated by the participants eligible for the stop-loss productivity-adjusted inpatient hospital policy are projected to account for 1.2 A key assumption underlying of the market basket update in our simulation. percent of the Model episode spending, impact estimate is that the volume and We forecast that net OPPS updates will and we estimate the five-year cost of intensity (V&I) of the bundled services outpace the PFS by 3.0 percent on this policy to be $0.3 million, an per episode remains unchanged average annually between 2019 and immaterial impact on the savings between the period used for rate setting 2025. estimate as displayed in Table 1. and when payments are made. If V&I Revisions to the projected impacts were to decrease by 1.0 percent (3) Medicare Estimate primarily reflect the net effects of annually for the bundled services absent Table 1 summarizes the estimated changes to the Model start and end the RO Model, then we estimate the impact of the RO Model. The estimated dates, refinements to the randomization impact of the RO Model to Medicare impact reflects the finalized policies, procedures used for CBSA selection, spending to be approximately budget which are different than some of the and a reduction in the proposed neutral between January 1, 2021 and proposed rule policies. For instance, we discount factors by 0.25 percent. 2025. Similarly if V&I increases by 1.0 are finalizing policies for reduced We project that 83 percent of percent annually then net outlays would discount factors, a smaller Model size of physician participants (measured by be reduced by $470 million for the 30 percent of RO episodes in eligible unique NPI) would receive the APM projection period. Although V&I growth geographic areas, a low volume opt-out incentive payment under the Quality from 2014 through 2018 fell within this option, a stop-loss policy for RO Payment Program at some point (at least 1.0 percent range and did not exhibit a participants with fewer than 60 one QP Performance Period) during the secular trend, actual experience may episodes during 2016–2018 and were model performance period. This differ. Please also note that due to the furnishing included RT services in the assumption is based on applying the current public health crisis caused by CBSAs selected for participation at the 2020 QPP final rule qualification criteria the COVID–19 virus, the forecasted time of the effective date of this final to simulated billing and treatment impacts for the RO Model are subject to rule, and a Model performance period of patterns for each QPP performance year an additional level of uncertainty. The January 1, 2021 through December 31, during the RO Model test. Episode- duration of the current COVID–19 2025. Thus, we are now estimating that initiating physicians were assumed to pandemic, its severity, and the policy on net the Medicare program will save form an APM entity with the TIN(s) measures taken as a response are $230 million over the Model under which they bill for RT services. variables that are significant but performance period. As in the proposed For each APM entity, counts of total unknown at this time. This forecast rule, this is the net Medicare Part B treated patients and spending for assumes that Medicare FFS billing and impact that includes both Part B covered physician services under the treatment patterns for beneficiaries premium and Medicare Advantage RO Model were estimated and applied observed during the 2016–2018 baseline United States Per Capita Costs (MA to QPP qualification criteria based on period resume by the start of 2021. To USPCC) rate financing interaction CY2018 provider billing patterns. the extent that this assumption does not effects. This estimate excludes changes As explained in section III.C.9 of this hold, actual experience may vary in beneficiary cost sharing liability to final rule, the APM incentive payment significantly. the extent it is not a Federal outlay will apply only to the professional This table summarizes our estimated under the policy. episode payment amounts and not the impacts of this final rule:

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b. ESRD Treatment Choices Model in magnitude over the duration of the will be updated on a rolling basis every (1) Overview Model. We will assess each ETC 6 months. Participant’s home dialysis rate, as The ETC Model will not be a total cost Under the ESRD Prospective Payment described in § 512.365(b), and ETC of care model. ETC Participants will still System (PPS) under Medicare Part B, a Participant’s transplant rate, as bill FFS Medicare, and items and single per-treatment payment is made to described in § 512.365(c), for each services not subject to the ETC Model’s an ESRD facility for all of the renal Measurement Year. The ETC payment adjustments will continue to dialysis services defined in section Participant’s transplant rate, which is be paid as they would in the absence of 1881(b)(14)(B) of the Act and furnished calculated as the sum of the risk the Model. to individuals for the treatment of ESRD adjusted transplant waitlist rate and (2) Data and Methods in the ESRD facility or in a patient’s living donor transplant rate, will be home. Under the Physician Fee aggregated, as described in 512.365(e), A stochastic simulation was created to Schedule, medical management of an and the ETC Participant’s home dialysis estimate the financial impacts of the ESRD beneficiary receiving dialysis by a rate will be aggregated, as described in Model relative to baseline expenditures. physician or other practitioner is paid § 512.365(e). The ETC Participant will The simulation relied upon statistical through the MCP. The ETC Model is a receive a Modality Performance Score assumptions derived from mandatory payment model designed to (MPS) based on the weighted sum of the retrospectively constructed ESRD test payment adjustments to certain higher of the ETC Participant’s facilities’ and Managing Clinicians’ dialysis and dialysis-related payments, achievement score or improvement Medicare dialysis claims and transplant as discussed in section IV. of this final score for the home dialysis rate and the waitlist data reported during 2016 and rule, for ESRD facilities and for higher of the ETC Participant’s 2017, the most recent years with Managing Clinicians for claims with achievement score or improvement complete data available. Both datasets dates of service from January 1, 2021 to score for the transplant rate, as and the risk-adjustment methodologies June 20, 2027. described in § 512.370(d). The for the ETC Model were developed by Under the ETC Model, there will be achievement scores will be calculated in the CMS Office of the Actuary. two payment adjustments designed to relation to a set of benchmarks based on The ESRD facilities and Managing increase rates of home dialysis and the historical rates of home dialysis and Clinicians datasets were restricted to the kidney transplants through financial inclusion on the transplant waitlist following eligibility criteria. incentives. The HDPA is an upward among ESRD facilities and Managing Beneficiaries must be residing in the payment adjustment on certain home Clinicians located in Comparison United States, 18 years of age or older, dialysis claims for ESRD facilities, as Geographic Areas. As discussed in the and enrolled in Medicare Part B. described in §§ 512.340 and 512.350, proposed rule and section IV.C.5.d. of Beneficiaries enrolled in Medicare and to certain home dialysis-related this final rule, we intend to increase Advantage or other cost or Medicare claims for Managing Clinicians, as these benchmarks over time. Any such managed care plans, who have elected described in §§ 512.345 and 512.350, changes would be made through hospice, receiving dialysis for acute during the initial 3 years of the ETC subsequent notice and comment kidney injury (AKI) only, is residing in Model. rulemaking. The improvement score or receiving dialysis in a skilled nursing The PPA is an upward or downward will be calculated in relation to a set of facility (SNF) or nursing facility, or has payment adjustment on certain dialysis benchmarks based on the ETC a diagnosis of dementia were excluded. and dialysis-related claims submitted by Participant’s own historical In addition, the HRR was matched to the ETC Participants, as described in performance. The ETC Participant’s claim service facility zip code or the §§ 512.375(a) and 512.380 for ESRD MPS for a MY will determine the rendering physician zip code for ESRD facilities and §§ 512.375(b) and 512.380 magnitude of its PPA during the facility and Managing Clinician, for Managing Clinicians, which will corresponding 6-month PPA Period, respectively. apply to claims with claim service dates which will begin 6 months after the end For the modeling exercise used to beginning on July 1, 2022 and increase of the MY. An ETC Participant’s MPS estimate changes in payment to

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providers and suppliers and the year. The waitlist counts for the growth observed during years 2017 resulting savings to Medicare, OACT numerator included waitlists for kidney through 2019 in the CCSQ data, to maintained the previous method transplants, alone or with another organ, project rates of growth. The annual proposed to identify ESRD facilities active and inactive records, multi-organ growth rate was from the median with common ownership, the low- listings, and patients that have transplant waitlist rate across HRR volume exclusion threshold, and the subsequently been removed from the condensed facilities growing from 8 aggregation assumptions as these waitlist. The denominator was a unique percent in 2017 to 10 percent in 2018 proposed changes are unlikely to have count of prevalent dialysis patients as of to 13 percent in 2019 (that is, not a a significant impact in terms of our the end of the year. Only patients on growth rate of 1.02 percent per year). modeling. To clarify OACT’s dialysis as of December 31st for the methodology, the ESRD facilities data selected year were included. Facility To assess the impact of COVID–19 on were aggregated to the CMS attribution was based on the facility the the kidney transplant waitlist, we Certification Number (CCN) level for patient was admitted to on the last day analyzed data from the United Network beneficiaries on dialysis identified by of the year. for Organ Sharing (UNOS).161 The outpatient claims with Type of Bill The effects of the living donor UNOS data suggest that the number of 072X to capture all dialysis services transplants are described in two new patients added to the kidney furnished at or through ESRD facilities. sections of this RIA. First, we provide a transplant waitlist steadily decreased Beneficiaries receiving home dialysis sensitivity estimate in the ‘‘Effects on between the weeks of March 15, 2020 services were defined as condition Kidney Transplantation’’ section that through May 3, 2020, when between 16 codes 74, 75, 76, and 80. Beneficiaries includes the impact of living donor to 81 percent of patients listed on the receiving in-center dialysis services transplants. Since the sensitivity weekly kidney transplant waitlist were defined using condition codes 71, estimate is not part of the main model’s became inactive due to COVID–19 72, and 73. For consistency with the calculations, the overall savings to precautions. During June and July 2020, Medicare estimate was not impacted. exclusion in § 512.385(a), after grouping the number of new patients added to the Second, we describe the modified within each HRR, aggregated ESRD kidney transplant waitlist increased to facilities with less than 132 total transplant rate that includes two parts, near pre-pandemic levels with an attributed beneficiary months during a the transplant waitlist rate and the given MY were excluded. When living donor transplant rate in the average of less than 4 percent of patients constructing benchmarks, for ‘‘Effects of the Revised Transplant Rate’’ listed as inactive due to COVID–19. consistency with the methodology for section. OACT’s conclusion of the Therefore, we assume that the number aggregating performance for purposes of modified transplant rate was that the of new patients added to the waitlist the PPA calculation, we aggregated all preemptive and living donor transplants will not decrease as a result of the ESRD facilities owned in whole or in are limited in frequency among the pandemic and the linear 2 percentage part by the same dialysis organization Medicare primary payer population; point growth rate for the transplant located in the same HRR. therefore, their inclusion in the waitlist calculated using years 2017 The Managing Clinicians’ transplant waitlist scores is not through 2019 CCSQ data does not need performance data were aggregated to the estimated to significantly impact overall to be revised to account for COVID–19. TIN level (for group practices) and the payments under the Model. The HDPA calculation required a individual NPI level (for solo The home dialysis score and simplified methodology, with home practitioners). For purposes of transplant waitlist score for the PPA dialysis and home dialysis-related calculating the home dialysis rate, were calculated using the following beneficiaries on home dialysis and were methodology for the ESRD facilities and payments adjusted by decreasing identified using outpatient claims with Managing Clinicians. ETC Participant amounts (3, 2, and 1 percent) during CPT® codes 90965 and 90966. behavior for each year was simulated by each of the first 3 years of the Model. Beneficiaries receiving in-center dialysis adjusting the ETC Participant’s baseline The Kidney Disease Education (KDE) were identified by outpatient claims home dialysis (or transplant waitlist) benefit utilization and cost data were with CPT® codes 90957, 90958, 90959, rate for a simulated statistical identified by codes G0420 and G0421, to 90960, 90961, and 90962. Similar to our fluctuation and then summing with the capture face-to-face individual and decision for the ESRD facilities, we did assumed increase in home dialysis (or group training sessions for chronic not expect the proposed changes to the transplant waitlist) rate multiplied by a kidney disease beneficiaries on low-volume threshold for the Managing randomly generated improvement treatment modalities. The home dialysis Clinicians to have a significant impact scalar. The achievement and training costs for incident beneficiaries improvement scores were assigned by on the model’s estimate. To clarify, on home dialysis for Continuous within each HRR, OACT applied a low- comparing the ETC Participant’s Ambulatory Peritoneal Dialysis (CAPD) volume exclusion to Managing simulated home dialysis (or transplant or Continuous Cycler-Assisted Clinicians in the bottom 5 percent in waitlist) rate for the MY to the Peritoneal Dialysis (CCPD) were defined terms of beneficiary-years for which the percentile distribution of home dialysis ® Managing Clinician billed the MCP (or transplant waitlist) rates in the prior using CPT codes 90989 and 90993 for during the year. The aggregation method year. Last, the MPS was calculated using complete and incomplete training may vary when the ETC Model is the weighted sum of the higher of the sessions, respectively. executed. achievement or improvement score for Data from calendar year 2017 were The Scientific Registry of Transplant the home dialysis rate and the used to project baseline expenditures Recipients (SRTR) transplant waitlist transplant waitlist rate. The home and the traditional FFS payment system data were obtained from the Center for dialysis rate constituted two-thirds of billing patterns were assumed to Clinical Standards and Quality (CCSQ). the MPS, and the transplant waitlist rate continue under current law. To construct the transplant waitlist rate, one-third of the MPS. the numerator was based on per-patient In addition, the waitlist benchmarks 161 UNOS. 2020. COVID–19 and Solid Organ counts and included every addition to were annually inflated by Transplants. Transplant and Waitlist Data the waitlist for a patient in any past approximately 2 percentage points Visualizations. https://unos.org/covid/.

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(3) Medicare Estimate—Primary utilization and transplant waitlist rates impractical (for example, obesity); Specification, Assume Rolling for Medicare FFS beneficiaries that CMS current equipment and staffing Benchmark virtually attributed to ESRD facilities constraints; and the likelihood that a and to Managing Clinicians based on the Table 2 summarizes the estimated patient new to maintenance dialysis plurality of associated spending at the impact of the ETC Model when starts dialysis at home compared to the beneficiary level. We analyzed the base assuming a rolling benchmark where the likelihood that a current dialysis patient variation in those facility/practice level achievement benchmarks for each year who dialyzes in center switches to measures and simulated the effect of the are set using the average of the home dialysis at home. The 3 percentage point payment policy assuming providers and dialysis rates for year t-1 and year t-2 for per year max growth rate will, in effect, suppliers respond by marginally the HRRs randomly selected for move the average market peritoneal increasing their share of patients participation in the ETC Model. We dialysis rate (about 10 percent) to the utilizing home dialysis. Random highest market baseline peritoneal estimate the Medicare program will save variables were used to vary the a net total of $32 million from the PPA dialysis rate (for example, Bend, Oregon effectiveness that individual providers HRR at about 25 percent), which we and HDPA between January 1, 2021 and and suppliers might show in such June 30, 2027 less $9 million in believe is a reasonable upper bound on progression over time and to simulate growth over the duration of the ETC increased training and education the level of year-to-year variation expenditures. Therefore, the net impact Model for the purposes of this actuarial already noted in the base multi-year model. to Medicare spending is estimated to be data that was analyzed. The uncertainty $23 million in savings. In Table 2, in the projection was illustrated through Consolidated ESRD facilities at the negative spending reflects a reduction in an alternate scenario assuming that the HRR level or Managing Clinicians were Medicare spending, while positive benchmarks against which ETC assumed to achieve anywhere from zero spending reflects an increase. The Participants are measured were to not be to 100 percent of such maximum growth results were generated from an average updated as well as a discussion of the in any given year. Thus, the average of 500 simulations under the 10th and 90th percentiles of the projected growth for the share of assumption that benchmarks are rolled actuarial model output. These maintenance dialysis provided in the forward with a 1.5-year lag. The sensitivity analyses are described in home was 1.5 percentage points per projections do not include the Part B sections VII.C.2.b.(3)(a) and year. Projected forward, this will result premium revenue offset because the VII.C.2.b.(3)(b) of this final rule, in home dialysis ultimately representing payment adjustments under the ETC respectively. KDE sessions on treatment approximately 19 percent of overall Model will not affect beneficiary cost- modalities and home dialysis (HD) maintenance dialysis in Selected sharing. Any potential effects on training for incident dialysis Geographic Areas by the end of 2027. In Medicare Advantage capitation beneficiaries are relatively small outlays contrast, we do not include an official payments were also excluded from the and were projected to represent only assumption that the overall number of projections. This approach is consistent relatively modest increases in Medicare kidney transplants will increase and with how CMS has previously conveyed spending each year. provide justification for this assumption the primary Fee-For-Service effects The key assumptions underlying the in section VII.C.2.b.(4). of this final rule. anticipated for an uncertain model impact estimate are that each However, as part of the sensitivity without also assessing the potential consolidated ESRD facility or Managing analysis for the savings calculations for impact on Medicare Advantage rates. Clinician’s share of total maintenance the model, we lay out different savings As anticipated, the expected Medicare dialysis provided in the home setting scenarios if the incentives under the program savings were driven by the net was assumed to grow by up to an ETC Model were to cause an increase in effect of the Facility PPA; a reduction in assumed maximum growth averaging 3 living donation and if the ETC Learning Medicare spending of $57 million over percentage points per year. Factors Collaborative described in section the period from July 1, 2022 through underlying this assumption about the IV.C.12 of this final rule were to be June 30, 2027. In comparison, the net home dialysis growth rate include: successful in decreasing the discard rate effect of the Clinician PPA was only $1 Known limitations that may prevent of deceased donor kidneys and million in Medicare savings. This patients from being able to dialyze at increasing the utilization rate of estimate was based on an empirical home, such as certain common disease deceased donor kidneys that have been study of historical home dialysis types that make peritoneal dialysis retrieved.

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(a) Sensitivity Analysis: Medicare million occurs in 2026, followed by a population’s exposure to COVID–19. In Estimate—Assume Fixed Benchmark for slight deceleration in 2027 to $7 million July 2020, CMS proposed expanding the Home Dialysis and Fixed Benchmark for in savings. In contrast, when benchmark transitional add-on payment adjustment Transplants targets are fixed, losses are projected for for new and innovative equipment and the net impact to Medicare spending supplies, or TPNIES, to include certain An alternative model specification (net of education and training but before capital-related assets that are home was analyzed where benchmarks remain administrative cost) in years 2022–2026 dialysis machines, which would make it fixed at baseline year 0 over time of $4, $7, $22, $39, and $26 million, easier to get them to Medicare (results available upon request). Both respectively. The fixed benchmark will beneficiaries. If finalized, this policy the rolling and fixed benchmark allow the ESRD facilities and Managing would take effect January 1, 2021. Since assumptions projected $12 and $11 Clinicians to have more favorable we have not been able to observe the million, respectively, in increased achievement and improvement scores impact of this rule on potential changes overall HDPA Medicare payments to over time compared to the rolling to the home dialysis rates, we propose ESRD facilities and Managing Clinicians benchmark method. In summary, the to keep the benchmark for home dialysis in the first year of the Model. We project total of overall net PPA and HDPA from as rolling. about $1 million in additional HD January 1, 2021 through June 30, 2027, The UNOS data show that after the training add-on payments. This will with the fixed benchmark, was $102 first wave of COVID–19, the number of represent $13 and $12 million in million in losses, compared to a total of new patients being added to the kidney increased Medicare expenditures in the $32 million in savings with the rolling transplant waitlist was approaching pre- first year of the Model overall. The benchmark method. The net impact on pandemic levels by July 2020. rolling and fixed specifications of the Medicare spending for the PPA and Specifically, the number of kidney benchmark also projected the net impact HDPA using the fixed benchmark transplants experienced a slight decline of approximately $7 and $8 million, method is $117 million in losses. starting April 12, 2020 in response to respectively, in increased Medicare fewer living donor transplants; however, expenditures in the second year of the (b) Sensitivity Analysis: Medicare the overall kidney transplant rate Model. Estimate—Assume Rolling Benchmark remained stable when comparing the The two scenarios diverge after the for Home Dialysis and Fixed Benchmark slope for the same dates in 2019. It is second year of the Model, with large for Transplants in Response to COVID– unknown how future waves of COVID– differences observed in overall net PPA 19 19 may affect the kidney transplant and HDPA savings/losses. Table 2 At the time of writing, there were only waitlist and the transplant rate. To illustrates that when benchmarks are six months of data available on COVID– address this uncertainty, we tested the rolled forward, using the methodology 19 in the United States. A few recent actuarial model by setting the described in section VII.C.2.b.(3). of this publications cite advantages of home benchmark to be rolling for home final rule, the overall savings in PPA net dialysis in combination with telehealth dialysis and fixed for transplants and and HDPA increase each year during the in comparison to in-center dialysis by did not find the model to be sensitive 2022–2026 period. Peak savings of $15 reducing the vulnerable ESRD to incremental changes in the transplant

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rate because most of the weighting is overall quantity of transplants could be total living kidney donations 166 determined by the home dialysis score. positively impacted by reducing the received NLDAC support, resulting in discard rate for certain DDKT with up to $3 million in paid expenses per (c) Sensitivity Analysis: Medicare lower quality, high-Kidney Donor year. Additional methods are necessary Savings Estimate—Results for the 10th Profile Index (KDPI) organs. However, to decrease financial disincentives for and 90th Percentiles while such transplantation has been kidney donors and their recipients who Returning to the primary specification shown to improve the quality of exceed the means testing criteria of the used for the Medicare estimate with outcomes for patients, kidney transplant NLDAC. rolling benchmarks for home dialysis centers have reported barriers to their The costs/savings incurred by kidney and transplants, we compare the results use including a higher cost of providing transplantation vary by donor type. (available upon request) for the top 10th care in such relatively complex Axelrod et al. (2018) used Medicare and 90th percentiles of the 500 transplant cases relative to Medicare’s claims data with Medicare as the individual simulations to the average of standard payment. Because the PPA will primary payer linked to national registry all simulation results reported in Table not impact payment to transplant and hospital cost-accounting data 2. Since the impact on Medicare centers, the ETC Model will not mitigate provides evidence for the cost-savings of spending for the ETC Model using the the barrier to increased marginal kidney kidney transplantations by donor type rolling benchmark method is estimated transplantations. Furthermore, even to compared to dialysis.167 The authors to be in savings rather than losses, the the extent that marginal DDKT were estimated ESRD expenditures to be top 10th and 90th percentiles represent somehow improved because of PPA $292,117 over 10 years per beneficiary the most optimistic and conservative incentives, evidence also suggests that on dialysis. LDKT was cost-saving at 10 projections, respectively. The overall the impact of DDKT with high-KDPI years, reducing expected expenditures net PPA and HDPA for the top 10th and organs may not reduce overall spending for ESRD treatment by 13 percent 90th percentiles using the rolling despite improving the quality of ($259,119) compared to maintenance benchmark method are $79 million in outcomes for patients. dialysis. In contrast, DDKT with low- savings and $7 million in losses It is possible that the ETC Model KDPI organs was cost-equivalent at (encompassing the mean estimate of $32 could generate additional living donor $297,286 over 10 years compared to million in savings in Table 2). kidney donations for which significant dialysis. Last, DDKT with high-KDPI Medicare program savings could be organs resulted in increased spending of (4) Effects on Kidney Transplantation realized. given that the living donor $330,576 over 10 years compared to Kidney transplantation is considered transplant rate is a component of the dialysis. the optimal treatment for most ESRD transplant rate used in calculating the The approximately $33,000 in savings beneficiaries. However, while the PPA PPA. In addition, additional patient per beneficiary over 10 years for LDKT includes a one-third weight on the education could lead more beneficiaries compared to maintenance dialysis is ESRD facilities’ or Managing Clinician’s to find donors by tapping into resources likely a lower bound since living transplant rate, calculated as the sum of already available to remove financial donation will help reduce the number of the transplant waitlist rate and living disincentives to donors (for example, beneficiaries under the age of 65 who donor transplant rate, with the ultimate payment for travel, housing, loss of will be eligible for Medicare enrollment. goal of increasing the rate of kidney wages, and post-operative care).163 164 The lower bound conditional savings transplantation including from deceased The ETC Model does not include a can be adjusted to account for donors, we decided to not include an policy to assist with minimizing additional savings through reduced assumption that the overall number of disincentives to living donors for their Medicare enrollment by considering the kidney transplants will increase. The kidney donation; however, qualified share of potential new live donations number of ESRD patients on the kidney donors may apply for financial across three main scenarios. transplant waitlist has for many years assistance through the National Living The LDKT expected cost of $259,119 far exceeded the annual number of Donor Assistance Center (NLDAC), over 10 years per beneficiary projected transplants performed. Transplantation which administers federal funding by Axelrod et al. (2018) assumes rates have not increased to meet such received from HRSA under the federal Medicare primary payer status. For demand because of the limited supply Organ Donation Recovery and roughly 25 percent of LDKTs, Medicare of deceased donor kidneys. The United Improvement Act.165 All applicants can be assumed to be the primary payer States Renal Data System 162 reported under this Act are means tested, with regardless of transplant success; 20,161 kidney transplants in 2016 preference given to recipients and therefore, the projected spending need compared to an ESRD transplant waiting donors who are both below 300 percent not be adjusted. For the next 25 percent list of over 80,000. Living donor kidney of the federal poverty line (FPL). of LDKTs, we assumed the beneficiary transplantation (LDKT) has actually Approved applicants can receive up to is on dialysis and Medicare is the declined in frequency over the last $6,000 to cover travel, lodging, meals, primary payer, but they will eventually decade while deceased donor kidney and incidental expenses. In 2017, only leave Medicare enrollment if they had a transplantation (DDKT) now represent 8.38 percent of the approximate 6,000 transplant. We adjusted the expected nearly three out of four transplants as of Medicare spending for these cases 2016. 163 Salomon DR, Langnas AN, Reed AI, et al. downward by 33 percent. This projected The PPA’s transplant incentive will 2015. ‘‘AST/ASTS Workshop on Increasing Organ a savings of approximately $119,000 Donation in the United States: Creating an ’Arc of over 10 years relative to the baseline likely increase the share of ESRD Change’ From Removing Disincentives to Testing beneficiaries who join the transplant Incentives.’’ American Journal of Transplantation spending projection of $292,117 over 10 waitlist but is unlikely to impact the 15: 1173–1179. deceased donor kidney supply 164 Tong A, Chapman JR, Wong G, Craig JC. 2014. 166 OPTN & SRTR 2017 Annual Report. Section KI ‘‘Perspectives of Transplant Physicians and Kidney Transplants. https://www.srtr.org/reports- limitation. There is evidence that the Surgeons on Reimbursement, Compensation, and tools/srtroptn-annual-data-report/. Incentives for Living Kidney Donors.’’ American 167 Axelrod DA, Schnitzler MA, Xiao H, et al. 162 United States Renal Data System. 2018. ‘‘ADR Journal of Kidney Disorders 64(4):622–632. 2018. ‘‘An Economic Assessment of Contemporary Reference Table 6 Renal Transplants by Donor 165 Public Law 108–216 (section 377 of the Public Kidney Transplant Practice.’’ American Journal of Type.’’ Health Service (PHS) Act, 42 U.S.C. 274f). Transplantation 18: 1168–1176.

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years for beneficiaries on dialysis. The Medicare spending will still be present attributed ESRD beneficiaries is divided third scenario—covering the remaining due to early graft failure before the end by the total attributed ESRD beneficiary 50 percent of LDKTs– assumes Medicare of the 10-year window (recognizing the dialysis treatment years. is not the primary payer when the shorter lifespan high-KDPI organs tend The goal of these revised formulas is transplant occurs. In this case, we to offer recipients). to give credit to model participants with assumed that Medicare spending is Combining these assumptions beneficiaries who are on the kidney nominal relative to baseline spending produced an average 10-year savings to transplant waitlist and who receive a and we adjust downward by 33 percent Medicare of approximately $32,000 per transplant from a living donor (that is, the beneficiary will take up to beneficiary for DDKT with high-KDPI. transplant. Data from the SRTR show 30 months to become a Medicare Overall, we found an increase in that in 2018, 1.8 percent of all living primary payer enrollee absent the marginal kidney utilization such that donor transplant recipients had a transplant), which projected a savings of the national discard rate will drop to 15 preemptive transplant and 62.3 percent approximately $195,000 over 10 years. percent by the end of the model testing had a wait time of less than 1 year.169 The projected weighted average program period, representing approximately The SRTR data also report that only 39.7 2,360 additional transplants and an savings for LDKT is $136,000 over 10 percent of all living donor transplants estimated $76 million in federal savings. years per beneficiary. (including preemptive) had Medicare as For both living and deceased donor Therefore, a 20 percent increase in the the primary payer. We also used the rate of LDKT in model markets in a transplants, the illustrated potential effect of the model will reduce long run SRTR data to confirm that year 2018, the single year, representing about 300 new most recent year with data available, transplants mainly from relatives of program spending by $116 million. Costs for this effort include a learning was not an anomaly and we found that recipients, will produce approximately years 2016–2018 had similar rates of $41 million in program savings over 10 and diffusion investment of $15 million in section 1115A administrative funds wait time for living donor transplants. years (and multiples thereof for each In addition, we calculated total member successive year the living donor over the model testing period and a potential increase in PPA adjustments to months from the Medicare data in the transplant rate were thusly elevated). IDR and found that in 2018, all living The model also includes an clinician and facility payments of donor transplant member months investment in learning and diffusion for approximately $20 million. The (regardless of wait time) accounted for improving the utilization of deceased projected increase in transplantation is only 0.6 percent of total member months donor kidneys that are currently estimated to produce a net savings of among beneficiaries on dialysis. discarded at a rate of approximately 19 $81 million—a net return on investment percent nationally.168 Similar to the of approximately 2.3. Because the living donor transplants previously discussed estimate on the and pre-emptive living donor (5) Effects of the Revised Transplant transplants (variables ‘‘d’’ and ‘‘c’’ in the average impact to Medicare spending for Rate LDKT, we estimated an average proposed formulas) are limited in marginal savings to Medicare for DDKT This final rule includes a modified frequency among the Medicare primary by adjusting costs reported by Axelrod transplant rate that includes two parts, payer population, their inclusion in the et al. (2018) for DDKT with high-KDPI the ‘‘transplant waitlist rate’’ and the transplant waitlist scores is not to account for effects on Medicare payer ‘‘living donor transplant rate.’’ The estimated to significantly impact overall status. We include three scenarios based ESRD facility transplant rate is payments under the model. This is on type of payer. calculated as the sum of the transplant partly due to limited effects expected for First, we assumed 50 percent of newly waitlist rate for ESRD facilities, risk the transplant waitlist score at the harvested deceased-donor kidneys will adjusted based on age strata, and the clinician and facility levels, but also be for beneficiaries enrolled in living donor transplant rate for ESRD because model payments are more Medicare, regardless of ESRD status. facilities. For purposes of calculating heavily weighted on the home dialysis This scenario aligns with the Medicare the transplant waitlist rate for ESRD measure. primary payer estimates from the study, facilities, the sum of the attributed ESRD beneficiary waitlist years is (6) Effects on the KDE Benefit and HD approximately $38,000 higher spending Training Add-Ons for DDKT with high-KDPI over 10 years divided by the total attributed ESRD relative to maintenance dialysis. beneficiary dialysis treatment years. For The KDE benefit has historically purposes of calculating the living donor Second, we assumed 30 percent of experienced very low uptake, with less transplant rate for ESRD facilities, the marginal DDKT will be for beneficiaries than 2 percent of eligible Medicare living donor transplant years for with Medicare as their primary coverage beneficiaries utilizing this option. A attributed ESRD beneficiaries is divided where the transplant spending was recent report summarized barriers to by the total attributed ESRD beneficiary adjusted downward by 33 percent to adequate education on home dialysis.170 dialysis treatment years. The Managing account for reduced liability for patients According to this report, kidney disease clinician transplant rate is calculated as returning to non-Medicare status. Third, education may: Not be provided at all, the sum of the transplant waitlist rate we assumed 20 percent of DDKT with be done only once, not be appropriate for Managing clinicians, risk adjusted high-KDPI will involve beneficiaries not for patient’s literacy level or not based on age strata, and the living donor yet under Medicare as their primary provided in patient’s native language, transplant rate for Managing clinicians. payer. For this scenario, we adjusted the not be done until after patient starts in- For purposes of calculating the baseline dialysis spending downward transplant waitlist rate for Managing by 33 percent to account for initial non- 169 SRTR 2018 Annual Report. Section KI Kidney clinicians, the sum of the attributed Medicare status during the waiting Transplants. https://srtr.transplant.hrsa.gov/ ESRD beneficiary waitlist years is _ _ _ _ period and for the transplant spending annual reports/2018/Kidney.aspx#KI 8 char divided by the total attributed ESRD adult_tx_dem. we assumed 25 percent of baseline beneficiary dialysis treatment years. For 170 Chan CT, Wallace E, Golper TA, et al. 2018. ‘‘Exploring Barriers and Potential Solutions in 168 OPTN & SRTR 2017 Annual Report. Section KI purposes of calculating the living donor Home Dialysis: An NKF–KDOQI Conference Kidney Transplants. https://www.srtr.org/reports- transplant rate for Managing clinicians, Outcomes Report.’’ American Journal of Kidney tools/srtroptn-annual-data-report/. the living donor transplant years for Disease 73(3): 363–371.

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center hemodialysis, and/or not be 3. Effects on Medicare Beneficiaries on cost sharing. We received a few provided to caregivers. a. Radiation Oncology Model comments regarding the application of The ETC Model will incorporate cost sharing under the ETC Model. We anticipate that the RO Model will Summaries of these comments, our waivers of select KDE benefit modestly reduce the cost to requirements that should make these response, and the details of our final beneficiaries receiving RT services on policy related to cost sharing are educational sessions on treatment average. Under current policy, Medicare modality options more accessible to available in section IV.C.7.a of this final FFS beneficiaries are generally required rule. In addition, the Medicare beneficiaries targeted by the model and to pay 20 percent of the allowed charge address some of the barriers previously beneficiary’s quality of life has the for services furnished by HOPDs and potential to improve if the beneficiary described. We assume the KDE benefit physicians (for example, those services utilization rate to increase from 2.2 in elects to have home dialysis as opposed paid for under the OPPS and MPFS, to in-center dialysis. Studies have found 2021 to 3.2 in 2027. To arrive at this respectively). This policy will remain assumption, we began with the current that home dialysis patients experienced the same under the RO Model. More improved quality of life as a result of low utilization of the benefit. The specifically, beneficiaries will be their ability to continue regular work utilization rate of the KDE benefit responsible for 20 percent of each of the schedules or life plans; 171 as well as during the first year of the Model was PC and TC episode payments made better overall, physical, and set to 2 percent of beneficiaries eligible under the RO Model. Since we are psychological health 172 173 in to use the KDE benefit, which is finalizing our proposal to take a comparison to other dialysis options. consistent with the current rate of percentage ‘‘discount’’ off of the total utilization of the benefit. We set the payment to participants for both PC and 4. Effects on RO Participants and ETC utilization growth rate to increase by 0.2 TC episode payment amounts (this Participants percentage points each year from 2021 discount representing savings to to 2027. This results in a projected Medicare), the total allowed charge for RO participants will be given doubling of the costs attributed to the services furnished by HOPDs and instructions on how to bill for patients, KDE benefit to approximately $1 million physicians is expected to decrease. using RO Model-specific HCPCS codes. in 2027. Although the ETC Model will Thus, beneficiary cost-sharing, on We expect it will take medical coding ∼ allow different types of health care average, should be reduced relative to staff approximately 0.72 hours [((( 36 providers to furnish the KDE benefit to what typically would be paid under pages * 300 words/per page)/250 words beneficiaries, there is no direct evidence traditional Medicare FFS for an episode per minute)/60 minutes) = 0.72] 174 to that this will cause an increase in the of care. In addition, the limit on read and learn the payment utilization growth rate that differs beneficiary cost-sharing in the HOPD methodology and billing sections of the significantly from the historical rate. setting to the inpatient deductible will rule. In addition, we estimate an Challenges to increasing the utilization continue under the RO Model. additional 1 hour to review the relevant rate include: the beneficiary’s Managing In addition, we note that, because MLN Matters publication, 1 hour to read Clinician may not inform the episode payment amounts under the RO the RO Model billing guide, 1 hour to beneficiary of the option to seek KDE Model will include payments for RT attend the billing guidance webinar, and benefit sessions for a variety of reasons services that will be provided over 1 hour to review the pricing (for example—the Managing Clinician is multiple visits, individual beneficiary methodology training materials for a unaware of the KDE benefit, alternative coinsurance payments will be higher total of 4.72 hours. We estimate the treatment modalities are not feasible for than they would otherwise be for an median salary of a Medical Records and the beneficiary, or the clinician believes individual RT service visit. We Health Information Technician is $19.40 that the beneficiary will not be able to encourage RO participants to collect per hour, at 100 percent fringe benefit coinsurance for services furnished for a total of $38.80, using the wage make an informed choice about dialysis 175 modality after receiving the KDE under the RO Model in multiple information from the BLS. The total benefit); if informed of the KDE benefit installments. 171 Da˛browska-Bender M, Dykowska G, Zuk W, et option, the beneficiary may prefer to We received a few comments regarding the application of al. 2018. ‘‘The impact on quality of life of dialysis rely on their Managing Clinician’s patients with renal insufficiency.’’ Patient Prefer recommendation rather than receive coinsurance. Summaries of these Adherence 12: 577–583. education about their treatment options; comments, our response, and the details 172 Makkar V, Kumar M, Mahajan R, Khaira NS. 2015. ‘‘Comparison of Outcomes and Quality of Life and the beneficiary may not want to on our final policy related to coinsurance are available in section between Hemodialysis and Peritoneal Dialysis have an additional one to six sessions Patients in Indian ESRD Population.’’ J Clin Diagn with a health care provider for the III.C.6.i. of this final rule. Res. 9(3): OC28–OC31. provision of the KDE benefit, as b. ESRD Treatment Choices Model 173 Van Eps CL, Jeffries JK, Johnson DW, et al. 2010. ‘‘Quality of life and alternate nightly beneficiaries with late stage CKD and We anticipate that the ETC Model will nocturnal home hemodialysis.’’ Hemodial ESRD are medically fragile and already have a negligible impact on the cost to Int.14(1):29–38. in frequent contact with the health care 174 https://aspe.hhs.gov/system/files/pdf/242926/ beneficiaries receiving dialysis. Under _ system. current policy, Medicare FFS HHS RIAGuidance.pdf. 175 For the RO Model, we use the estimated The impacts of increased utilization beneficiaries are generally responsible median hourly wage of $19.40 per hour, plus 100 of the home dialysis (HD) training add- for 20 percent of the allowed charge for percent overhead and fringe benefits. Estimating the on payment adjustment under the ESRD services furnished by providers and hourly wage is necessarily a rough adjustment, both PPS are expected to be larger than the suppliers. This policy will remain the because fringe benefits and overhead costs vary significantly from employer-to-employer and KDE benefit costs as these trainings will same under the ETC Model. However, because methods of estimating these costs vary be required for all incident beneficiaries we will waive certain requirements of widely from study-to-study. Nonetheless, we on home dialysis. Assuming a stable 3 title XVIII of the Act as necessary to test believe that doubling the hourly wage rate to percent growth rate in home dialysis per the PPA and HDPA under the Model estimate total cost is a reasonably accurate estimation method and allows for a conservative year, the 7-year total in HD training and to hold beneficiaries harmless from estimate of hourly costs. costs is projected to be $10 million. any effect of these payment adjustments Continued

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cost of learning the billing system for ETC Participants related to quality PGPs that are categorized as the RO Model thus is $183.14 per measures or clinical data reporting. freestanding radiation therapy centers; participant, or approximately Finally, we believe the burden and (4) HOPDs. The majority of HOPDs $173,983.00 in total (950 expected estimate for reading and interpreting and other RT providers and RT participants × $183.14/participant = this final rule that is provided for Small suppliers are small entities, either by $173,983 total). Businesses apply to RO participants and being nonprofit organizations or by The ETC Model will not alter the way ETC Participants that are not considered meeting the SBA definition of a small ETC Participants bill Medicare. small entities. The burden estimate for business (defined as having minimum Therefore, we believe that there will be reading and interpreting this final rule revenues of less than $12 million to no additional burden for ETC may be equal to or less than that for $41.5 million 176 in any 1 year, Participants related to billing practices. small businesses. We estimate that cost depending on the type of provider; the We believe the audit and retention of reading the rule for RO participants $41.5 million per year threshold is for policies of the RO Model and ETC would be approximately $1,093.26 per hospitals, whereas the $12 million per Model are generally consistent with entity with a total cost of approximately year threshold is for other entities). existing policies under Medicare. $3,170,454.00 (2,900 eligible entities × (https://www.sba.gov/document/ Additionally, the monitoring $1,093.269/participant). In sum, we support--table-size-standards). States requirements for the RO Model and ETC estimate that reading the RO Model rule, and individuals are not included in the Model are consistent with the learning the RO billing system, the definition of small entity. monitoring and evaluation requirements pricing methodology and submitting HHS uses an RFA threshold of at least already in place under 42 CFR quality measures and clinical data to the a 5 percent impact on revenues of small 405.1110(b) for participants in models RO Model will cost approximately entities to determine whether a final tested under section 1115A of the Act. $3,019.47 per RO participant ($1,093.26 rule is likely to have ‘‘significant’’ Therefore, we believe the audit and to read the rule, $183.14 to attend and impacts on small entities.177 retention policies and the monitoring learn the billing guidance, and Throughout the rule we describe how and evaluation requirements do not add $1,743.07 to submit quality measure and the changes to a prospective episode additional regulatory burden on CDE information), and collectively cost payment may affect PGPs and HOPDs. participants. approximately $2,868,496.50 across the In the proposed rule, we provided an The model evaluation for both the RO 950 RO participants, and an additional analysis for the RO Model’s impact on Model and the ETC Model will include $2,131,350.00 for those providers and small businesses based on the proposed beneficiaries and providers completing suppliers who read the rule, but are not policies and following analysis (84 FR surveys. Burden for these surveys will ultimately selected as RO participants, 34575 through 34577). Our analysis was depend on the length, complexity, and for a total cost $4,999,846.50. Similarly, based on the assumption that the RO frequency of surveys administered as we base our estimate for the cost of Model would include only Medicare needed to ensure confidence in the reading the final rule for ETC FFS beneficiaries receiving RT services survey findings. We will make an effort Participants on the same cost per by selected PGPs (including to minimize the length, complexity, and participant as used for the RO Model, freestanding radiation therapy centers) frequency of the surveys. A typical that is, $1,093.26 per entity. We assume and HOPDs. During 2018, 39 percent of survey on average would require about that all ESRD facilities and Managing Medicare beneficiaries with both Part A 20 minutes of the respondent’s time. In Clinicians will read the rule, even and B coverage on average are estimated other evaluations of models where a though only a subset of each category to have enrolled in Medicare Advantage survey is required, the frequency of will participate in the Model. Therefore, plans.178 PGPs and HOPDs also serve surveys varies from a minimum of one the collective cost will be $6,714,000 patients with other coverage, for round of surveys to annual surveys. (14,380 entities reading the rule (7,097 example, through Medicare or We believe the burden estimate for ESRD facilities plus 7,283 Managing commercial insurance. We believed that quality measure and clinical data Clinicians) times $466.89). on average, Medicare FFS payments to element reporting requirements that is 5. Regulatory Flexibility Act (RFA) PGPs would be reduced by 5.9 percent provided for Small Businesses in and Medicare FFS payments to HOPDs The RFA, as amended, requires section VII.C.5.a. of this final rule apply would be reduced by 4.2 percent and agencies to analyze options for to RO participants that are not would not change with an April 1 start regulatory relief of small entities, if a considered small entities. The burden date. Given that this Model is limited to rule has a significant impact on a estimate for collecting and reporting only Medicare FFS beneficiaries, not substantial number of small entities. For quality measures and clinical data for other payers including Medicare purposes of the RFA, small entities the RO Model may be equal to or less Advantage and commercial insurance, include small businesses, nonprofit than that for small businesses, which we which combined we expect to be about organizations, and small governmental estimate to be approximately $1,743.07 50 to 60 percent of total HOPD and PGP per entity per year. We estimate jurisdictions. As discussed in sections approximately 950 RO participants, VII.5.a and VII.5.b. of this final rule, the 176 Please note these numbers are updated from then total burden estimate for collecting Secretary has considered small entities the proposed rule due to an update on SBA and reporting quality measures and and has determined and certifies that categorizations. The small business revenue clinical data was approximately this final rule will not have a significant numbers were previously $11.5 million and 38.5 economic impact on a substantial million, respectively. $1,655,916.50. 177 Office of Advocacy, Small Business Additionally, the ETC Model does not number of small entities. Administration. (2012). A Guide for Government require any additional quality measure a. Radiation Oncology Model Agencies, How to Comply with the Regulatory or clinical data element reporting by Flexibility Act, Implementing the President’s Small ETC Participants. Therefore, we believe This final rule affects: (1) Radiation Business Agenda and Executive Order 13272, oncology PGPs that furnish RT services Retrieved from www.sba.gov/sites/default/files/ that there is no additional burden for rfaguide_0512_0.pdf (accessed March 18, 2019). in both freestanding radiation therapy 178 This figure comes from the 2018 Medicare https://www.bls.gov/ooh/Healthcare/Medical- centers and HOPDs; (2) PGPs that Trustees Report, Table IV.V1, p151 from the records-and-health-information-technicians.htm. furnish RT services only in HOPDs; (3) footnote that has the A and B share.

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revenue for RT services, we expected clinical data elements which may be 46 percent of their payer mix and that that the anticipated average impact of included across the five cancer types this coupled with episode payment revenue based solely on Medicare FFS (prostate, breast, lung, bone and brain) amounts that would reduce payment by payments to be less than 1 percent. finalized in section III.C.8. of this final up to 50 percent from what participants Therefore, we determined that the rule. We note that the final list will be would have received under FFS, makes proposed rule would not have a greater communicated prior to the start of PY1, furnishing RT services under the Model than 5 percent impact on total revenues so our estimate may slightly overstate or unsustainable. on a substantial number of small entities understate the final number of CDEs Response: We thank this commenter (84 FR 34577). We estimated the (and thus may slightly understate or for their feedback. First, as we stated in administrative costs of adjusting to and overstate the burden) and each RO section III.C.6. of this final rule, we complying with the quality measure and participant’s experience may vary. We disagree that episode payment amounts clinical data element reporting still expect the burden costs per small would be reduced by 50 percent as requirements for RO Model for small entity associated with measure and data compared to non-participants. This entities to be approximately $388.00 per reporting to be small because three of might be true for some participants if entity per year. To estimate the costs per the four measures for the RO Model are the case mix and historical experience small entity, we assumed that a Medical already in use in other CMS programs; adjustments were removed from the Records & Health Information and compliance with the Treatment Model’s pricing methodology. We Technician with an Hourly salary (from Summary Communication (the measure designed the pricing methodology so BLS) plus 100 percent fringe benefits not currently in use) is a best practice that episode payment amounts for would cost $38.80/hour 179 and would that should already be the standard of Professional participants, Dual report the information on quality care across PGPs and HOPDs. participants, and Technical participants measures and clinical data elements. We In the proposed rule, we further are largely based on what each expected submission of the 4 quality estimated the administrative cost of participant has been paid historically data measures would take reading and interpreting this final rule under FFS and trended forward based approximately 8 hours and would per small entity at approximately on latest payment rates under FFS. In require submission once a year, ($38.80 $446.89 (84 FR 34577). We are updating particular, we refer readers to section × 8.0 hours × 1 submission) = $310.40. our estimate to approximately $1,093.26 III.C.6.e.(2). of this final rule for more In the proposed rule, also we estimated for reading the rule and an additional information regarding the blend used to that the submission of clinical data $183.14 to learn the billing system. We determine how much participant- elements would take up to an hour, but expect that a medical health service specific historical payments and occur twice a year, that is, ($38.80 × 1- manager reading 250 words per minute national base rates figure into payment. hour × 2 submission) = $77.60 per year could review the rule in approximately Second, RT services furnished under the (84 FR 34577). 11.4 hours [(approximately 569 pages * RO Model were assumed to grow with Based on the final design of the RO 300 words/per page)/250 words per FFS Medicare Part B enrollment as Model, we believe that on average, minute) 180 60 minutes)]. We estimated projected in the 2018 Medicare Trustees Medicare FFS payments to PGPs will be the salary of a medical and health Report. We assume that participants do reduced by 6.0 percent and Medicare service manager is $95.90 per hour, not change payer mix as a response to FFS payments to HOPDs will be using the wage information from the the RO Model. No explicit assumptions reduced by 4.7 percent. We believe that BLS including overhead and fringe were made about the relative amount of this impact would be less for small benefits.181 Assuming an average RT services paid through private or providers that provide fewer than 20 reading speed for pages relevant to the other forms of insurance. episodes in the previous year and RO Model, we estimated that it would Comment: A commenter stated that choose to opt out of the Model under take approximately 11.4 hours for the providers and suppliers chosen for the the low volume opt out policy (see staff to review the RO portion of this Model will see reductions to their section III.C.3.c. of this final rule) final rule. For each provider that payments under the Hospital Outpatient because they would continue to bill FFS reviews the rule, the estimated cost PPS or PFS, respectively, between 3.9 for RT services furnished during their based on the expected time and salary percent and 4.4 percent (PC) and opt out year(s). In response to of the person reviewing the rule between 5.7 and 5.1 percent (TC) on commenter feedback, we are updating ($1,093.26 = ($95.90 * 11.4 hrs). RO average, with participants furnishing RT our estimate for the administrative costs participants would also review the services in freestanding radiation of adjusting to and complying with the billing guidance, which we would therapy centers experiencing a higher quality measure and clinical data expect to cost approximately $183.14 as reduction than those furnishing RT element reporting requirements for RO discussed in section VI.C.4. of this final services in the HOPD setting. According Model for small entities to be rule. to this commenter, the combined effect approximately $1,743.06 per entity per We solicited public comments on our of the discount factor and efficiency year. We assume that our estimate for estimates and analysis of the impact of factor, now termed, ‘‘blend,’’ will the submission of quality measures the final rule on those small entities. reduce payments by 6.6 percent in the remains an accurate estimate at $310.40 Comment: A commenter expressed fifth year and the commenter expressed per year. We revisited our clinical data concern with the RO Model’s payment concern that this reduction would not element estimates and now expect the rates estimates based on their belief that be offset by the APM bonus incentive total cost of submission of the clinical Medicare is a material payer for the for technical payments, and even so, data elements would be approximately majority of providers. The commenter this is waived under the Model as $1,432.67 per entity ($38.80 × 18.5 added that Medicare is, or may exceed, proposed. hours × 2 submissions) per year. Our Response: We appreciate the estimate was updated based on our 180 https://aspe.hhs.gov/system/files/pdf/242926/ commenters concerns regarding the HHS_RIAGuidance.pdf. combined effect of the discount factor review of the potential list of the 181 For the RO Model, we use an estimated median hourly wage of $47.95 per hour, plus 100 and blend. We believe that the 179 https://www.bls.gov/ooh/Healthcare/Medical- percent overhead and fringe benefits. https:// commenters’ estimates are consistent records-and-health-information-technicians.htm. www.bls.gov/oes/current/oes119111.htm. with our analysis, though we note, we

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are finalizing policies that reduce the the clinical setting and is not solely providers were forecasted to be 0.5 discount factor by 0.25 percent for both used for RO Model measures reporting. percent of RO episode allowed charges. the PC and TC, so that the discount rates The cost of the EHR system should not Please note that for any individual are 3.75 percent and 4.75 percent for the be reflected in the burden estimates provider a range of potential outcomes PC and TC, respectively as we discussed developed specifically for the RO may occur due to the RO model and that in section III.C.6. We are also finalizing Model. We also note that American actual experience may vary. the Model performance period to begin Recovery and Reinvestment Act of 2009 We expect the anticipated average January 1, 2021 in order to give RO (ARRA) (Pub. L. 111–5) and Meaningful impact of revenue based solely on participants the necessary time to Use require providers to use EHRs to Medicare FFS payments to be less than prepare for implementation. avoid Medicare payment reductions, 1 percent. We therefore expect that this Comment: A few of commenters which is independent of any proposals final rule would not have a greater than stated their belief that the regulatory in the RO Model. Third, and as we 5 percent impact on total revenues on a impact analysis severely underestimates stated in section III.C.7. of this final substantial number of small entities. burden on participants. A commenter rule, we believe that we have created a b. ESRD Treatment Choices Model estimated that the cost of adjusting to billing process that will be easily the Model could be well over $400,000 implemented within current systems, This final rule includes as ETC in PY1 and $350,000 in each successive because it is based on how FFS claims Participants Managing Clinicians and PY. Another commenter estimated that are submitted today and may reduce the ESRD facilities required to participate in 0.3 FTEs per physician would be amount of time spent billing because the Model pursuant to § 512.325(a). We needed to account for the newly created coding will be submitted at the assume for the purposes of the workflow related to the revenue cycle beginning and end of the episode. regulatory impact analysis that the great majority of Managing Clinicians are processes as well as quality metric and Lastly, we believe that the 45–60 small entities and that the greater data documentation, collection and minutes per patient file that one majority of ESRD facilities are not small reporting that will exist alongside the stakeholder estimates is an overestimate entities. Throughout the final rule we current workflow already established for of the time it will take to review a chart describe how the adjustments to certain patients outside of the RO Model. and submit quality measures for the RO payments for dialysis services and To better account for cost, a couple of Model, nor do we believe the cost and dialysis-related services furnished to commenters suggested that CMS utilization reports of OCM are ESRD beneficiaries may affect Managing consider the following: The additional comparable to that of the RO Model. Clinicians and ESRD facilities administrative tasks and requirements The RO Model does not mandate the that the Model imposes, the use of participating in the ETC Model. The same OCM reporting requirements. We great majority of Managing Clinicians certified EHR technology, the need to also believe that we have included prepare multiple billings and participate are small entities by meeting the SBA measures that are commonly used in the in a radiation oncology-specific AHRQ definition of a small business (having field and reflect common treatment patient safety organization, and the need minimum revenues of less than $11 practices. However, as discussed earlier to participate in CMS site visits and million to $38.5 million in any 1 year, in this section, we are updating our medical record audits. A few varying by type of provider and highest estimates for the burden associated with commenters recommended a review of for hospitals) with a minimum quality measure and clinical data OCM’s cost and utilization reports, threshold for small business size of element submission and our estimates which they believe would show that $38.5 million (https://www.sba.gov/ of the cost it would take to read the rule manual data abstraction alone document/support--table-size-standards and learn the billing. represents 45–90 minutes per patient http://www.sba.gov/content/small- and requires thousands of dollars in We believe that on average the businesssize-standards). The great human resources to implement. Another updated policies contained in this final majority of ESRD facilities are not small commenter claimed that OCM practices rule will result in reductions of 5.9 entities, as they are owned, partially or also spend tens of thousands of dollars percent to underlying fee schedules for entirely by entities that do not meet the each year to meet the clinical data RT services over the course of the model SBA definition of small entities. element and quality measure reporting test, which is similar to the proposed The HDPA in the ETC Model would requirements under that model, as rule. The final rule payment reduction be a positive adjustment on payments captured in the OCM cost and resource was estimated by simulating RT for specified home dialysis and home utilization reports that are submitted to episodes using 2018 claims and dialysis-related services. The PPA in the CMS. assuming that the relative value units ETC Model, which includes both Response: We thank these under the PFS and relative payment positive and negative adjustments on commenters for explaining their weights under the OPPS by providers payments for dialysis services and concerns. First, we believe the would remain unchanged in the future. dialysis-related services, excludes administrative, monitoring, and Another key assumption is that the aggregation groups with fewer than 132 compliance requirements for the RO distribution of provider efficiency as attributed beneficiary-months during Model will not substantially diverge defined in (section III.C.1. of this final the relevant year. from general monitoring requirements rule) during 2018 would remain For the remaining small entities that for Medicare Part B providers. RO unchanged in future years under the are above the low-volume exclusion participants are already subject to site current FFS payment system. Although threshold and randomly selected for visits and record audits as part of their discounts were reduced by 0.25 percent participation, the design of the ETC participation in Medicare, so we do not between the proposed and final rule, Model will incorporate a risk expect the Model requirements to create this was approximately offset by an adjustment of the transplant waitlist rate additional burden. Second, we disagree additional year of data underlying the and aggregation of the home dialysis that the use of EHR technology should distribution of provider efficiency. rate and transplant waitlist rate to allow be included in the regulatory impact Moreover, these estimated fee schedule for the calculation of home dialysis rates analysis as part of the cost of the Model. reductions do not include APM bonuses and transplant waitlist rates for both An entity’s EHR has many uses within payable to participants. APM bonuses to small entities that may be owned in

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whole or in part by another company. are finalizing a low volume opt out This final rule contains a model The transplant waitlist rate is risk policy, described in section III.C.3.(c). of specific to radiation oncology. It adjusted based on age, as described in this final rule. provides descriptions of the section IV.C.5.b.(3). of the final rule. 6. Unfunded Mandates Reform Act requirements that we will waive, The aggregation methodology groups identifies the payment methodology to ESRD facilities owned in whole or in Section 202 of the Unfunded be tested, and presents rationales for our part by the same dialysis organization Mandates Reform Act of 1995 (UMRA) decisions and, where relevant, within a Selected Geographic Area and (Pub. L. 104–04, enacted on March 22, alternatives that we considered. We Managing Clinicians billing under the 1995) also requires that agencies assess carefully considered the alternatives to same TIN within a Selected Geographic anticipated costs and benefits before this final rule, including whether the Area. This aggregation policy increases issuing any rule whose mandates RO Model should be implemented by all the number of beneficiary months, and require spending in any 1 year of $100 RT providers and RT suppliers thus statistical reliability, of the ETC million in 1995 dollars, updated nationwide. We concluded that it would Participant’s home dialysis and annually for inflation. In 2020, that is be best to test the model using a subset transplant rate for ESRD facilities that approximately $168 million. This final of all RT providers and RT suppliers in are owned in whole or in part by the rule does not mandate any requirements order to compare them to the RT same dialysis organization and for for State, local, or tribal governments, or providers and RT suppliers that would Managing Clinicians that share a TIN for the private sector. not be participating in the RO Model. with other Managing Clinicians. 7. Federalism Taken together, the low volume This final rule also contains a model threshold exclusions, risk adjustments Executive Order 13132 establishes specific to ESRD. It provides of the transplant rate, and aggregation certain requirements that an agency descriptions of the requirements that we policies previously described, coupled must meet when it promulgates a will waive, identifies the performance with the fact that the ETC Model will proposed rule (and subsequent final metrics and payment adjustments to be affect Medicare payment only for select rule) that imposes substantial direct tested, and presents rationales for our services furnished to Medicare FFS requirement costs on state and local decisions, and where relevant, beneficiaries; we have determined that governments, preempts state law, or alternatives that we considered. We the provisions of this final rule will not otherwise has Federalism implications. carefully considered the alternatives to have a significant impact on spending This rule would not have a substantial this final rule, including whether the for a substantial number of small direct effect on state or local model should be implemented to entities (defined as greater than 5 governments, preempt state law, or include more or fewer ESRD facilities percent impact). No comments were otherwise have a Federalism and Managing Clinicians. We concluded received regarding the impact of the implication because both the RO Model that it would be best to test the model ETC Model that were not addressed and ETC Model are Federal payment with approximately 30 percent of ESRD elsewhere. programs impacting Federal payments facilities and Managing Clinicians in the only and do not implicate local U.S. in order to have an effective 5. Effects on Small Rural Hospitals governments or state law. Therefore, the comparison group and to provide the Section 1102(b) of the Act requires requirements of Executive Order 13132 best opportunity for an accurate and CMS to prepare a RIA if a rule may have are not applicable. thorough evaluation of the model’s a significant impact on the operations of effects. a substantial number of small rural D. Reducing Regulation and Controlling Regulatory Costs We solicited comments on our hospitals. This analysis must conform to proposals and on any Model alternatives Executive Order 13771, titled the provisions of section 604 of the and consequent policies that should be Reducing Regulation and Controlling RFA. For purposes of section 1102(b) of considered. We refer readers to section Regulatory Costs (82 FR 9339), was the Act, we define a small rural hospital III.C and IV.C of this final rule for more issued on January 30, 2017. This final as a hospital that is located outside a information on policy-related rule is not expected to be subject to the Metropolitan Statistical Area and has stakeholder comments, our responses to fewer than 100 beds. requirements of E.O. 13771 because it is those comments, and statements of final We are not preparing an analysis for estimated to result in no more than de policy. section 1102(b) of the Act because we minimis costs. have determined, and the Secretary F. Accounting Statement and Table certifies, that the RO Model and ETC E. Alternatives Considered Model will not have a significant impact Throughout this final rule, we have As required by OMB Circular A–4 on the operations of a substantial identified our policies and alternatives under Executive Order 12866 (available number of small rural hospitals. that we have considered, and provided at http://www.whitehouse.gov/omb/ We received a number of comments information as to the likely effects of circulars_a004_a4) in Tables E3 and E4, regarding the impact of certain RO these alternatives and the rationale for we have prepared an accounting Model policies on rural hospitals. We each of our policies. We solicited statement showing the classification of direct readers to section III of this final comments on our proposals, on the transfers which represent savings rule and in the policy sections to which alternatives we have identified, and on associated with the provisions in this they applied where addressed these other alternatives that we should final rule. The accounting statement is comments. We also note that in consider, as well as on the costs, based on estimates provided in this response to stakeholder feedback, we benefits, or other effects of these. regulatory impact analysis.

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G. Conclusion 512.130 Cooperation in model evaluation Billing and Payment and monitoring. This analysis, together with the 512.260 Billing. 512.135 Audits and record retention. remainder of this preamble, provides 512.265 Payment. 512.140 Rights in data and intellectual 512.270 Treatment of add-on payments the Regulatory Impact Analysis of a rule property. under existing Medicare payment with a significant economic effect. As a 512.150 Monitoring and compliance. systems. result of this final rule, we estimate that 512.160 Remedial action. Data Reporting the financial impact of the Radiation 512.165 Innovation center model Oncology Model and ESRD Treatment termination by CMS. 512.275 Quality measures, clinical data, Choices Model will net a federal savings 512.170 Limitations on review. and reporting. of $253 million over a 6.5-year 512.180 Miscellaneous provisions on Medicare Program Waivers bankruptcy and other notifications. performance period (2021 through 512.280 RO Model Medicare program 2027). Subpart B—Radiation Oncology Model waivers. In accordance with the provisions of Executive Order 12866, this final rule General Reconciliation and Review Process was reviewed by the Office of 512.200 Basis and scope of subpart. 512.285 Reconciliation process. Management and Budget. 512.205 Definitions. 512.290 Timely error notice and reconsideration review process. List of Subjects in 42 CFR Part 512 RO Model Participation Subpart C—ESRD Treatment Choices Model Administrative practice and 512.210 RO participants and geographic procedure, Health facilities, Medicare, areas. General Reporting and recordkeeping 512.215 Beneficiary population. 512.300 Basis and scope. requirements. 512.217 Identification of individual 512.310 Definitions. practitioners. ■ For the reasons set forth in the ESRD Treatment Choices Model Scope and 512.220 RO participant compliance with preamble and under the authority at 42 Participants RO Model requirements. U.S.C. 1302, 1315a, and 1395hh, the 512.225 Beneficiary notification. 512.320 Duration. Centers for Medicare & Medicaid 512.325 Participant selection and Services amends 42 CFR chapter IV by Scope of RO Episodes Being Tested geographic areas. adding part 512 to read as follows: 512.230 Criteria for determining cancer 512.330 Beneficiary notification. types. Home Dialysis Payment Adjustment PART 512—RADIATION ONCOLOGY 512.235 Included RT services. MODEL AND END STAGE RENAL 512.340 Payments subject to the facility 512.240 Included modalities. HDPA. DISEASE TREATMENT CHOICES 512.245 Included RO episodes. 512.345 Payments subject to the clinician MODEL Pricing Methodology HDPA. 512.350 Schedule of home dialysis payment Subpart A—General Provisions Related to 512.250 Determination of national base adjustments. Innovation Center Models rates. Sec. 512.255 Determination of participant- Performance Payment Adjustment 512.100 Basis and scope. specific professional episode payment 512.355 Schedule of performance 512.110 Definitions. and participant-specific technical assessment and performance payment 512.120 Beneficiary protections. episode payment amounts. adjustment.

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512.360 Beneficiary population and under the Securities Exchange Act of otherwise included in an Innovation attribution. 1934), directly or indirectly, of voting Center model under the terms of this 512.365 Performance assessment. securities of the model participant part. 512.370 Benchmarking and scoring. representing more than 50 percent of the Model participant means an 512.375 Payments subject to adjustment. individual or entity that is identified as 512.380 PPA amounts and schedule. model participant’s outstanding voting 512.385 PPA exclusions. securities or rights to acquire such a participant in the Innovation Center 512.390 Notification and targeted review. securities. model under the terms of this part. (2) The acquisition of the model Model-specific payment means a Quality Monitoring participant by any individual or entity. payment made by CMS only to model 512.395 Quality measures. (3) The sale, lease, exchange or other participants, or a payment adjustment Medicare Program Waivers transfer (in one transaction or a series of made only to payments made to model transactions) of all or substantially all of participants, under the terms of the 512.397 ETC Model Medicare program the assets of the model participant. Innovation Center model that is not waivers. (4) The approval and completion of a applicable to any other providers or Authority: 42 U.S.C. 1302, 1315a, and plan of liquidation of the model suppliers. 1395hh. participant, or an agreement for the sale Provider means a ‘‘provider of or liquidation of the model participant. services’’ as defined under section Subpart A—General Provisions Covered services means the scope of 1861(u) of the Act and codified in the Related to Innovation Center Models health care benefits described in definition of ‘‘provider’’ at § 400.202 of § 512.100 Basis and scope. sections 1812 and 1832 of the Act for this chapter. (a) Basis. This subpart implements which payment is available under Part Supplier means a supplier as defined certain general provisions for the A or Part B of Title XVIII of the Act. in section 1861(d) of the Act and Radiation Oncology Model Days means calendar days. codified at § 400.202 of this chapter. Descriptive model materials and implemented under subpart B (RO U.S. Territories means American activities means general audience Model) and the End-Stage Renal Disease Samoa, the Federated States of materials such as brochures, (ESRD) Treatment Choices Model Micronesia, Guam, the Marshall Islands, advertisements, outreach events, letters implemented under subpart C (ETC and the Commonwealth of the Northern to beneficiaries, web pages, mailings, Model), collectively referred to in this Mariana Islands, Palau, Puerto Rico, social media, or other materials or subpart as Innovation Center models. U.S. Minor Outlying Islands, and the activities distributed or conducted by or Except as specifically noted in this part, U.S. Virgin Islands. on behalf of the model participant or its the regulations do not affect the downstream participants when used to § 512.120 Beneficiary protections. applicability of other provisions educate, notify, or contact beneficiaries (a) Beneficiary freedom of choice. (1) affecting providers and suppliers under regarding the Innovation Center model. The model participant and its Medicare Fee-For-Service (FFS), The following communications are not downstream model participants must including provisions regarding descriptive model materials and not restrict beneficiaries’ ability to payment, coverage, or program integrity. activities: Communications that do not choose to receive care from any provider (b) Scope. The regulations in this directly or indirectly reference the or supplier. subpart apply to model participants in Innovation Center model (for example, (2) The model participant and its the RO Model (except as otherwise information about care coordination downstream model participants must noted in § 512.160(b)(6)) and to model generally); information on specific not commit any act or omission, nor participants in the ETC Model. This medical conditions; referrals for health adopt any policy that inhibits subpart sets forth the following: beneficiaries from exercising their (1) Basis and scope. care items and services; and any other materials that are excepted from the freedom to choose to receive care from (2) Beneficiary protections. any provider or supplier or from any (3) Model participant requirements for definition of ‘‘marketing’’ as that term is health care provider who has opted out participation in model evaluation and defined at 45 CFR 164.501. of Medicare. The model participant and monitoring, and record retention. Downstream participant means an its downstream model participants may (4) Rights in data and intellectual individual or entity that has entered communicate to model beneficiaries the property. into a written arrangement with a model (5) Monitoring and compliance. participant under which the benefits of receiving care with the (6) Remedial action and termination downstream participant engages in one model participant, if otherwise by CMS. or more Innovation Center model consistent with the requirements of this (7) Limitations on review. activities. part and applicable law. (8) Miscellaneous provisions on Innovation Center model means the (b) Availability of services. (1) The bankruptcy and notification. RO Model implemented under subpart model participant and its downstream B or the ETC Model implemented under participants must continue to make § 512.110 Definitions. subpart C. medically necessary covered services For purposes of this part, the Innovation Center model activities available to beneficiaries to the extent following terms are defined as follows means any activities impacting the care required by applicable law. Model unless otherwise stated: of model beneficiaries related to the test beneficiaries and their assignees retain Beneficiary means an individual who of the Innovation Center model under their rights to appeal claims in is enrolled in Medicare FFS. the terms of this part. accordance with part 405, subpart I of Change in control means any of the Medically necessary means reasonable this chapter. following: and necessary for the diagnosis or (2) The model participant and its (1) The acquisition by any ‘‘person’’ treatment of an illness or injury, or to downstream participants must not take (as this term is used in sections 13(d) improve the functioning of a malformed any action to select or avoid treating and 14(d) of the Securities Exchange Act body member. certain Medicare beneficiaries based on of 1934) of beneficial ownership (within Model beneficiary means a beneficiary their income levels or based on factors the meaning of Rule 13d–3 promulgated attributed to a model participant or that would render the beneficiary an

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‘‘at-risk beneficiary’’ as defined at § 512.135 Audits and record retention. additional 6 years from the date of any § 425.20 of this chapter. (a) Right to audit. The Federal resulting final resolution of the (3) The model participant and its government, including CMS, HHS, and termination, dispute, or allegation of downstream participants must not take the Comptroller General, or their fraud or similar fault. any action to selectively target or engage designees, has the right to audit, (2) If CMS notifies the model beneficiaries who are relatively healthy inspect, investigate, and evaluate any participant of the special need to retain or otherwise expected to improve the documents and other evidence records in accordance with paragraph model participant’s or downstream regarding implementation of an (c)(1)(i) of this section or there has been participant’s financial or quality Innovation Center model. a termination, dispute, or allegation of performance, a practice commonly (b) Access to records. The model fraud or similar fault against the model referred to as ‘‘cherry-picking.’’ participant and its downstream participant or its downstream (c) Descriptive model materials and participants must maintain and give the participants described in paragraph activities. (1) The model participant and Federal government, including CMS, (c)(1)(ii) of this section, the model its downstream participants must not HHS, and the Comptroller General, or participant must notify its downstream use or distribute descriptive model their designees, access to all such participants of this need to retain materials and activities that are documents and other evidence records for the additional period materially inaccurate or misleading. sufficient to enable the audit, specified by CMS. (2) The model participant and its evaluation, inspection, or investigation of the implementation of the Innovation § 512.140 Rights in data and intellectual downstream participants must include property. Center model, including without the following statement on all (a) CMS may— descriptive model materials and limitation, documents and other evidence regarding all of the following: (1) Use any data obtained under activities: ‘‘The statements contained in §§ 512.130, 512.135, and 512.150 to this document are solely those of the (1) The model participant’s and its downstream participants’ compliance evaluate and monitor the Innovation authors and do not necessarily reflect Center model; and the views or policies of the Centers for with the terms of the Innovation Center model, including this subpart. (2) Disseminate quantitative and Medicare & Medicaid Services (CMS). qualitative results and successful care The authors assume responsibility for (2) The accuracy of model-specific payments made under the Innovation management techniques, including the accuracy and completeness of the factors associated with performance, to information contained in this Center model. (3) The model participant’s payment other providers and suppliers and to the document.’’ of amounts owed to CMS under the public. Data disseminated may include (3) The model participant and its Innovation Center model. patient— downstream participants must retain (4) Quality measure information and (i) De-identified results of patient copies of all written and electronic the quality of services performed under experience of care and quality of life descriptive model materials and the terms of the Innovation Center surveys, and activities and appropriate records for all model, including this subpart. (ii) De-identified measure results other descriptive model materials and (5) Utilization of items and services calculated based upon claims, medical activities in a manner consistent with furnished under the Innovation Center records, and other data sources. § 512.135(c). model. (b) Notwithstanding any other (4) CMS reserves the right to review, (6) The ability of the model provision of this part, for all data that or have a designee review, descriptive participant to bear the risk of potential CMS confirms to be proprietary trade model materials and activities to losses and to repay any losses to CMS, secret information and technology of the determine whether or not the content is as applicable. model participant or its downstream materially inaccurate or misleading. (7) Patient safety. participants, CMS or its designee(s) will This review takes place at a time and in (8) Other program integrity issues. not release this data without the express a manner specified by CMS once the (c) Record retention. (1) The model written consent of the model participant descriptive model materials and participant and its downstream or its downstream participant, unless activities are in use by the model participants must maintain the such release is required by law. participant. documents and other evidence (c) If the model participant or its described in paragraph (b) of this downstream participant wishes to § 512.130 Cooperation in model evaluation section and other evidence for a period and monitoring. protect any proprietary or confidential of six years from the last payment information that it submits to CMS or its The model participant and its determination for the model participant designee, the model participant or its downstream participants must comply under the Innovation Center model or downstream participant must label or with the requirements of § 403.1110(b) from the date of completion of any otherwise identify the information as of this chapter and must otherwise audit, evaluation, inspection, or proprietary or confidential. Such cooperate with CMS’ model evaluation investigation, whichever is later, assertions are subject to review and and monitoring activities as may be unless— confirmation by CMS prior to CMS’ necessary to enable CMS to evaluate the (i) CMS determines there is a special acting upon such assertions. Innovation Center model in accordance need to retain a particular record or with section 1115A(b)(4) of the Act and group of records for a longer period and § 512.150 Monitoring and compliance. to conduct monitoring activities under notifies the model participant at least 30 (a) Compliance with laws. The model § 512.150, including producing such days before the normal disposition date; participant and each of its downstream data as may be required by CMS to or participants must comply with all evaluate or monitor the Innovation (ii) There has been a termination, applicable laws and regulations. Center model, which may include dispute, or allegation of fraud or similar (b) CMS monitoring and compliance protected health information as defined fault against the model participant or its activities. (1) CMS may conduct in 45 CFR 160.103 and other downstream participants, in which case monitoring activities to ensure individually-identifiable data. the records must be maintained for an compliance by the model participant

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and each of its downstream participants associated with the purpose of the site (7) Is subject to investigation or action with the terms of the Innovation Center visit are available during all site visits. by HHS (including the HHS Office of model including this subpart; to (4) Additionally, CMS may perform Inspector General and CMS) or the understand model participants’ use of unannounced site visits at the office of Department of Justice due to an model-specific payments; and to the model participant and any of its allegation of fraud or significant promote the safety of beneficiaries and downstream participants at any time to misconduct, including being subject to the integrity of the Innovation Center investigate concerns about the health or the filing of a complaint or filing of a model. Such monitoring activities may safety of beneficiaries or other patients criminal charge, being subject to an include, without limitation, all of the or other program integrity issues. indictment, being named as a defendant following: (5) Nothing in this part shall be in a False Claims Act qui tam matter in (i) Documentation requests sent to the construed to limit or otherwise prevent which the Federal government has model participant and its downstream CMS from performing site visits intervened, or similar action. participants, including surveys and permitted or required by applicable law. (8) Has failed to demonstrate questionnaires. (d) Reopening of payment improved performance following any (ii) Audits of claims data, quality determinations. (1) CMS may reopen a remedial action imposed under this measures, medical records, and other model-specific payment determination section. data from the model participant and its on its own motion or at the request of (b) Remedial actions. If CMS downstream participants. a model participant, within 4 years from determines that one or more grounds for (iii) Interviews with members of the the date of the determination, for good remedial action described in paragraph staff and leadership of the model cause (as defined at § 405.986 of this (a) of this section has taken place, CMS participant and its downstream chapter). may take one or more of the following participants. (2) CMS may reopen a model-specific remedial actions: (iv) Interviews with beneficiaries and payment determination at any time if (1) Notify the model participant and, their caregivers. there exists reliable evidence (as defined if appropriate, require the model (v) Site visits to the model participant in § 405.902 of this chapter) that the participant to notify its downstream and its downstream participants, determination was procured by fraud or participants of the violation. performed in a manner consistent with similar fault (as defined in § 405.902 of (2) Require the model participant to paragraph (c) of this section. this chapter). provide additional information to CMS (vi) Monitoring quality outcomes and (3) CMS’s decision regarding whether or its designees. clinical data, if applicable. to reopen a model-specific payment (3) Subject the model participant to (vii) Tracking patient complaints and determination is binding and not subject additional monitoring, auditing, or both. appeals. to appeal. (4) Prohibit the model participant (e) OIG authority. Nothing contained (2) In conducting monitoring and from distributing model-specific in the terms of the Innovation Center oversight activities, CMS or its payments, as applicable. Model or this part limits or restricts the designees may use any relevant data or (5) Require the model participant to authority of the HHS Office of Inspector information including without terminate, immediately or by a deadline General or any other Federal limitation all Medicare claims specified by CMS, its agreement with a government authority, including its submitted for items or services downstream participant with respect to authority to audit, evaluate, investigate, furnished to model beneficiaries. the Innovation Center model. or inspect the model participant or its (c) Site visits. (1) In a manner (6) In the ETC Model only, terminate downstream participants for violations consistent with § 512.130, the model the ETC Participant from the ETC of any Federal statutes, rules, or participant and its downstream Model. regulations. participants must cooperate in periodic (7) Require the model participant to site visits performed by CMS or its submit a corrective action plan in a form § 512.160 Remedial action. and manner and by a deadline specified designees in order to facilitate the (a) Grounds for remedial action. CMS evaluation of the Innovation Center by CMS. may take one or more remedial actions (8) Discontinue the provision of data model and the monitoring of the model described in paragraph (b) of this sharing and reports to the model participant’s compliance with the terms section if CMS determines that the participant. of the Innovation Center model, model participant or a downstream (9) Recoup model-specific payments. including this subpart. participant: (10) Reduce or eliminate a model- (2) CMS or its designee provides, to (1) Has failed to comply with any of specific payment otherwise owed to the the extent practicable, the model the terms of the Innovation Center model participant. participant or downstream participant Model, including this subpart. (11) Such other action as may be with no less than 15 days advance (2) Has failed to comply with any permitted under the terms of this part. notice of any site visit. CMS— applicable Medicare program (i) Will attempt, to the extent requirement, rule, or regulation. § 512.165 Innovation center model practicable, to accommodate a request (3) Has taken any action that threatens termination by CMS. for particular dates in scheduling site the health or safety of a beneficiary or (a) CMS may terminate an Innovation visits. other patient. Center model for reasons including, but (ii) Will not accept a date request from (4) Has submitted false data or made not limited to, the following: a model participant or downstream false representations, warranties, or (1) CMS determines that it no longer participant that is more than 60 days certifications in connection with any has the funds to support the Innovation after the date of the CMS initial site visit aspect of the Innovation Center model. Center model. notice. (5) Has undergone a change in control (2) CMS terminates the Innovation (3) The model participant and its that presents a program integrity risk. Center model in accordance with downstream participants must ensure (6) Is subject to any sanctions of an section 1115A(b)(3)(B) of the Act. that personnel with the appropriate accrediting organization or a Federal, (b) If CMS terminates an Innovation responsibilities and knowledge State, or local government agency. Center model, CMS provides written

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notice to the model participant finally resolved. The notice of including the applicability of specifying the grounds for model bankruptcy must be sent by certified regulations regarding payment, termination and the effective date of mail no later than 5 days after the coverage, and program integrity. such termination. petition has been filed and must contain (b) Scope. This subpart sets forth the a copy of the filed bankruptcy petition following: § 512.170 Limitations on review. (including its docket number), and a list (1) RO Model participation. There is no administrative or judicial of all models tested under section (2) Episodes being tested under the review under sections 1869 or 1878 of 1115A of the Act in which the model RO Model. the Act or otherwise for all of the participant is participating or has (3) Methodology for pricing. following: participated. This list need not identify (4) Billing and payment under the RO (a) The selection of models for testing a model tested under section 1115A of Model. (5) Data reporting requirements. or expansion under section 1115A of the the Act in which the model participant Act. (6) Medicare program waivers. participated if final payment has been (7) Payment reconciliation and review (b) The selection of organizations, made under the terms of the model and sites, or participants, including model processes. all administrative or judicial review (c) RO participants are subject to the participants, to test the Innovation proceedings regarding model-specific Center models selected, including a general provisions for Innovation Center payments between the model models specified in subpart A of this decision by CMS to remove a model participant and CMS have been fully participant or to require a model part 512 and in subpart K of part 403 of and finally resolved with respect to that this chapter. participant to remove a downstream model. The notice to CMS must be participant from the Innovation Center addressed to the CMS Office of § 512.205 Definitions. model. Financial Management at 7500 Security For purposes of this subpart, the (c) The elements, parameters, scope, Boulevard, Mailstop C3–01–24, following definitions apply: and duration of such Innovation Center Baltimore, MD 21244 or such other Aggregate quality score (AQS) means models for testing or dissemination, address as may be specified on the CMS the numeric score calculated for each including without limitation the website for purposes of receiving such RO participant based on its performance following: notices. on, and reporting of, quality measures (1) The selection of quality (b) Notice of legal name change. A and clinical data. The AQS is used to performance standards for the model participant must furnish written determine an RO participant’s quality Innovation Center model by CMS. notice to CMS at least 30 days after any reconciliation payment amount. (2) The methodology used by CMS to change in its legal name becomes APM means Alternative Payment assess the quality of care furnished by effective. The notice of legal name Model. the model participant. change must be in a form and manner ASC means Ambulatory Surgery (3) The methodology used by CMS to specified by CMS and must include a Center. attribute model beneficiaries to the copy of the legal document effecting the Blend means the weight given to an model participant, if applicable. name change, which must be RO participant’s historical experience (d) Determinations regarding budget authenticated by the appropriate State adjustment relative to the neutrality under section 1115A(b)(3) of official. geographically-adjusted trended the Act. (c) Notice of change in control. (1) A national base rate in the calculation of (e) The termination or modification of model participant must furnish written its participant-specific episode payment the design and implementation of an notice to CMS in a form and manner amounts. Innovation Center model under section specified by CMS at least 90 days before CAH means Critical Access Hospital. 1115A(b)(3)(B) of the Act. CEHRT means Certified Electronic any change in control becomes effective. (f) Determinations about expansion of Health Record Technology. (2)(i) If CMS determines, in the duration and scope of an Innovation Clean period means the 28-day period accordance with § 512.160(a)(5), that a Center model under section 1115A(c) of after an RO episode has ended, during model participant’s change in control the Act, including the determination which time an RO participant must bill would present a program integrity risk, that an Innovation Center model is not for medically necessary RT services CMS may take remedial action against expected to meet criteria described in furnished to the RO beneficiary in the model participant under paragraph (a) or (b) of such section. accordance with Medicare FFS billing § 512.160(b). rules. § 512.180 Miscellaneous provisions on (ii) CMS may also require immediate Core-Based Statistical Area (CBSA) bankruptcy and other notifications. reconciliation and payment of all means a statistical geographic area, (a) Notice of bankruptcy. If the model monies owed to CMS by a model based on the definition as identified by participant has filed a bankruptcy participant that is subject to a change in the Office of Management and Budget, petition, whether voluntary or control. with a population of at least 10,000, involuntary, the model participant must Subpart B—Radiation Oncology Model which consists of a county or counties provide written notice of the bankruptcy anchored by at least one core (urbanized to CMS and to the U.S. Attorney’s Office General area or urban cluster), plus adjacent in the district where the bankruptcy was counties having a high degree of social filed, unless final payment has been § 512.200 Basis and scope of subpart. and economic integration with the core made by either CMS or the model (a) Basis. This subpart implements the (as measured through commuting ties participant under the terms of each test of the Radiation Oncology (RO) with the counties containing the core). model tested under section 1115A of the Model under section 1115A(b) of the Discount factor means the set Act in which the model participant is Act. Except as specifically noted in this percentage by which CMS reduces participating or has participated and all subpart, the regulations under this payment of the professional component administrative or judicial review subpart do not affect the applicability of and technical component. proceedings relating to any payments other regulations affecting providers and (1) The reduction on payment occurs under such models have been fully and suppliers under Medicare FFS, after the trend factor, the geographic

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adjustment, and the RO Model-specific (2) An RO beneficiary ceases to have technical component to an RO adjustments have been applied but traditional FFS Medicare as his or her beneficiary during an RO episode. before beneficiary cost-sharing and primary payer at any time after the Performance year (PY) means the 12- standard CMS adjustments, including initial treatment planning service is month period beginning on January 1 sequestration, have been applied. furnished and before the date of service and ending on December 31 of each year (2) The discount factor does not vary on a claim with an RO Model-specific during the Model performance period. by cancer type. HCPCS code and an EOE modifier; or PGP means physician group practice. (3) The discount factor for the (3) An RO beneficiary switches RT PPS means prospective payment professional component is 3.75 percent; provider or RT supplier before all system. the discount factor for the technical included RT services in the RO episode Professional component (PC) means component is 4.75 percent. have been furnished. the included RT services that may only Dual participant means an RO Individual practitioner means a be furnished by a physician. participant that furnishes both the Medicare-enrolled physician (identified Professional participant means an RO professional component and technical by an NPI) who furnishes RT services to participant that is a Medicare-enrolled component of RT services of an RO Medicare FFS beneficiaries, and has PGP identified by a single TIN that episode through a freestanding radiation reassigned his or her billing rights to the furnishes only the PC of an RO episode. therapy center, identified by a single TIN of an RO participant. PSO means patient safety TIN. Individual practitioner list means a organization. Duplicate RT service means any list of individual practitioners who PY means performance year. QP means Qualifying APM included RT service that is furnished to furnish RT services under the TIN of a Participants. an RO beneficiary by an RT provider or Dual participant or a Professional Reconciliation payment means a RT supplier that is not excluded from participant, which is annually compiled payment made by CMS to an RO participation in the RO Model at by CMS and which the RO participant participant, as determined in § 512.210(b), and that did not initiate must review, revise, and certify in accordance with § 512.285. the PC or TC of the RO beneficiary’s RO accordance with § 512.217. The Repayment amount means the episode. Such services are furnished in individual practitioner list is used for amount owed by an RO participant to addition to the RT services furnished by the RO Model as a Participation List as CMS, as determined in accordance with defined in § 414.1305 of this chapter. the RO participant that initiated the PC § 512.285. or TC and continues to furnish care to Initial reconciliation means the first Reconciliation report means the the RO beneficiary during the RO reconciliation of a PY that occurs as annual report issued by CMS to an RO episode. early as August following the applicable participant for each PY, which specifies Episode means the 90-day period of PY. the RO participant’s reconciliation RT services that begins on the date of MIPS means Merit based Incentive payment amount or repayment amount. service that an RT provider or RT Payment System. RO beneficiary means a Medicare supplier that is not an RO participant Model performance period means, beneficiary who meets all of the furnishes an initial treatment planning January 1, 2021, through December 31, beneficiary inclusion criteria at service to a beneficiary, provided that 2025, the last date on which an RO § 512.215(a) and whose RO episode an RT provider or RT supplier furnishes episode may end under the RO Model. meets all the criteria defined at a technical component RT service to the No new RO episodes may begin after § 512.245. beneficiary within 28 days of such October 3, 2025, in order for all RO RO episode means the 90-day period initial treatment planning service. episodes to end by December 31, 2025. that, as set forth in § 512.245, begins on Additional criteria for constructing National base rate means the total the date of service that a Professional episodes to be included in determining payment amount for the relevant participant or a Dual participant the national base rates are set forth in component of an RO episode, before furnishes an initial treatment planning § 512.250. application of the trend factor, discount service to an RO beneficiary in a EOE stands for ‘‘end of episode’’ and factor, adjustments, and applicable freestanding radiation therapy center or means the end of an RO episode. withholds, for each of the included an HOPD, provided that a Technical HCPCS means Healthcare Common cancer types. participant or the same Dual participant Procedure Coding System. NPI means National Provider furnishes a technical component RT HOPD means hospital outpatient Identifier. service to the RO beneficiary within 28 department. OPPS means outpatient prospective days of such RT treatment planning Included cancer types means the payment system. service. cancer types determined by the criteria Participant-specific professional RO participant means a Medicare- set forth in § 512.230, which are episode payment means a payment enrolled PGP, freestanding radiation included in the RO Model test. which is calculated by CMS as set forth therapy center, or HOPD that Included RT services means the RT in § 512.255 and which is paid by CMS participates in the RO Model in services identified at § 512.235, which to a Professional participant or Dual accordance with § 512.210. An RO are included in the RO Model test. participant as set forth in § 512.265, for participant may be a Dual participant, Incomplete episode means an RO the provision of the professional Professional participant, or Technical episode that is deemed not to have component to an RO beneficiary during participant. occurred because: an RO episode. RT provider means a Medicare- (1) A Technical participant or a Dual Participant-specific technical episode enrolled HOPD that furnishes RT participant does not furnish a technical payment means a payment which is services. component to an RO beneficiary within calculated by CMS as set forth in RT services are the treatment 28 days following a Professional § 512.255 and which is paid by CMS to planning, technical preparation, special participant or the Dual participant a Technical participant or Dual services (such as simulation), treatment furnishing an initial treatment planning participant in accordance with delivery, and treatment management service to that RO beneficiary; § 512.265, for the provision of the services associated with cancer

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treatment that uses high doses of (1) Furnishes RT services only in § 512.217 Identification of individual radiation to kill cancer cells and shrink Maryland; practitioners. tumors. (2) Furnishes RT services only in (a) General. Upon the start of each PY, RT supplier means a Medicare- Vermont; CMS creates and provides to each Dual enrolled PGP or freestanding radiation (3) Furnishes RT services only in U.S. participant and Professional participant therapy center that furnishes RT Territories; an individual practitioner list services. (4) Is classified as an ambulatory identifying by NPI each individual SOE stands for ‘‘start of episode’’ and surgery center (ASC), critical access practitioner associated with the RO means the start of an RO episode. hospital (CAH), or Prospective Payment participant. Stop-loss limit means the set System (PPS)-exempt cancer hospital; or (b) Review of individual practitioner percentage at which loss is limited (5) Participates in or is identified by list. Within 30 days of receipt of the under the Model used to calculate the CMS as eligible to participate in the individual practitioner list, the RO stop-loss reconciliation amount. Pennsylvania Rural Health Model. participant must review and certify the Stop-loss reconciliation amount (c) Low Volume Opt-Out. A PGP, individual practitioner list, correct any means the amount owed to RO freestanding radiation therapy center, or inaccuracies in accordance with participants that have fewer than 60 HOPD, which would otherwise be paragraph (d) of this section, and certify episodes during 2016–2018 and that required to participate in the RO Model the list (as corrected, if applicable) in a were furnishing included RT services on may choose to opt-out of the RO Model form and manner specified by CMS and November 30, 2020 in the CBSAs for a given PY if it has fewer than 20 in accordance with paragraph (c) of this selected for participation for the loss episodes of RT services across all section or correct the individual incurred under the Model as described CBSAs selected for participation in the practitioner list in accordance with in § 512.285(f). most recent year with claims data paragraph (d) of this section. Technical component (TC) means the available prior to the applicable PY. At (c) List certification. (1) Within 30 included RT services that are not least 30 days prior to the start of each days of receipt of the individual furnished by a physician, including the PY, CMS notifies RO participants practitioner list, and at such other times provision of equipment, supplies, eligible for the low volume opt-out for as specified by CMS, an individual with personnel, and administrative costs the upcoming PY. The RO participant the authority to legally bind the RO related to RT services. must attest to its intention of opting out participant must certify the accuracy, Technical participant means an RO of the RO Model prior to the start of the completeness, and truthfulness of the participant that is a Medicare-enrolled upcoming PY. individual practitioner list to the best of HOPD or freestanding radiation therapy (d) Selected CBSAs. CMS randomly his or her knowledge, information, and center, identified by a single CMS selects CBSAs to identify RT providers belief. (2) All Medicare-enrolled individual Certification Number (CCN) or TIN, and RT suppliers to participate in the practitioners that have reassigned their which furnishes only the TC of an RO RO Model through a stratified sample right to receive Medicare payment for episode. design, allowing for participant and provision of RT services to the TIN of TIN means Taxpayer Identification comparison groups to contain the RO participant must be included on Number. approximately 30 percent of all episodes the RO participant’s individual Trend factor means an adjustment in eligible geographic areas (CBSAs). applied to the national base rates that practitioner list and each individual updates those rates to reflect current § 512.215 Beneficiary population. practitioner must agree to comply with trends in the OPPS and PFS rates for RT (a) Beneficiary inclusion criteria. An the requirements of the RO Model services. individual is an RO beneficiary if: before the RO participant certifies the True-up reconciliation means the (1) The individual receives included individual practitioner list. (3) If the RO participant does not process to calculate additional RT services from an RO participant that certify the individual practitioner list: reconciliation payments or repayment billed the SOE modifier for the PC or TC (i) Eligible clinicians in the RO Model amounts for incomplete episodes and of an RO episode during the Model will not be considered participants in a duplicate RT services that are identified performance period for an included MIPS APM for purposes of MIPS after the initial reconciliation and after cancer type; and reporting and scoring rules; and a 12-month claims run-out for all RO (2) At the time that the initial (ii) Eligible clinicians in the RO episodes initiated in the applicable PY. treatment planning service of an RO Model will not have Qualifying APM RO Model Participation episode is furnished by an RO Participant (‘‘QP’’) determinations made participant, the individual: based on their participation in the RO § 512.210 RO participants and geographic (i) Is eligible for Medicare Part A and Model. areas. enrolled in Medicare Part B; (d) Changes to the individual (a) RO participants. Unless otherwise (ii) Has traditional FFS Medicare as practitioner list. (1) Additions. specified in paragraph (b) or (c) of this his or her primary payer (for example, (i) An RO participant must notify section, any RO participant that is not enrolled in a PACE plan, CMS of an addition to its individual furnishes included RT services in a 5- Medicare Advantage or another practitioner list within 30 days of when digit ZIP Code linked to a CBSA managed care plan, or United Mine an eligible clinician reassigns his or her selected for participation to an RO Workers insurance); and rights to receive payment from Medicare beneficiary for an RO episode that (iii) Is not in a Medicare hospice to the RO participant. The notice must begins on or after January 1, 2021, and benefit period. be submitted in the form and manner ends on or before December 31, 2025, (b) Any individual enrolled in a specified by CMS. must participate in the RO Model. clinical trial for RT services for which (ii) If the RO participant timely (b) Participant exclusions. A PGP, Medicare pays routine costs is an RO submits notice to CMS, then the freestanding radiation therapy center, or beneficiary if the individual satisfies all addition of an individual practitioner to HOPD is excluded from participation in of the beneficiary inclusion criteria in the RO participant’s individual the RO Model if it: paragraph (a) of this section. practitioner list is effective on the date

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specified in the notice furnished to (vi) Starting in PY1, discuss with each (b) Form and manner of notification. CMS, but no earlier than 30 days before RO beneficiary prior to treatment Notification of the information specified the date of the notice. If the RO delivery his or her inclusion in, and in paragraph (a) of this section must be participant fails to submit timely notice cost-sharing responsibilities under, the carried out by an RO participant by to CMS, then the addition of an RO Model; and providing each RO beneficiary with a individual practitioner to the individual (vii) Starting in PY1, perform and CMS-developed standardized written practitioner list is effective on the date document Peer Review (audit and notice during the RO beneficiary’s of the notice. feedback on treatment plans) before 25 initial treatment planning session. The (2) Removals. (i) An RO participant percent of the total prescribed dose has RO participants must furnish the notice must notify CMS no later than 30 days been delivered and within 2 weeks of to the RO beneficiary in the form and of when an individual on the RO the start of treatment for: manner specified by CMS. participant’s individual practitioner list (A) 50 percent of new patients in PY1, (c) Applicability of general Innovation ceases to be an individual practitioner. (B) 55 percent of new patients in PY2, Center provisions. The beneficiary The notice must be submitted in the (C) 60 percent of new patients in PY3, notifications under this section are not form and manner specified by CMS. (D) 65 percent of new patients in PY4, descriptive model materials and (ii) The removal of an individual (E) 70 percent of new patients in PY5. activities under § 512.120(c). The practitioner from the RO participant’s (3) Starting in PY1, at such times and requirement described in § 512.120(c)(2) individual practitioner list is effective in the form and manner specified by does not apply to the standardized on the date specified in the notice CMS, each Technical participant and written notice described in paragraph furnished to CMS. If the RO participant Dual participant must annually attest to (b) of this section. fails to submit a timely notice of the whether it actively participates with a removal, then the removal is effective AHRQ-listed patient safety organization Scope of RO Episodes Being Tested (PSO). Examples include maintaining a on the date that the individual ceases to § 512.230 Criteria for determining cancer be an individual practitioner. contractual or similar relationship with types. (e) Update to Medicare enrollment a PSO for the receipt and review of patient safety work product. (a) Included cancer types. CMS information. The RO participant must includes in the RO Model test cancer ensure that all changes to enrollment (b) CEHRT. (1) Each RO participant must use CEHRT, and ensure that its types that satisfy all of the following information for an RO participant and criteria. The cancer type: its individual practitioners, including individual practitioners use CEHRT, in a manner sufficient to meet the (1) Is commonly treated with changes to reassignment of the right to radiation; and receive Medicare payment, are reported applicable requirements of the Advanced APM criteria codified in (2) Has associated current ICD–10 to CMS consistent with § 424.516 of this codes that have demonstrated pricing chapter. § 414.1415(a)(1)(i) of this chapter. Before each PY, each RO participant must stability. § 512.220 RO participant compliance with certify in the form and manner, and by (b) Removing cancer types. CMS RO Model requirements. a deadline specified by CMS, that it uses removes cancer types in the RO Model (a) RO participant-specific CEHRT throughout such PY in a manner if it determines: requirements. (1) RO participants must sufficient to meet the requirements set (1) RT is no longer appropriate to treat satisfy the requirements of this section forth in § 414.1415(a)(1)(i) of this a cancer type per nationally recognized, to qualify for the APM Incentive chapter. evidence-based clinical treatment Payment. (2) Within 30 days of the start of PY1, guidelines; ≥ (2) Each Professional participant and the RO participant must certify its intent (2) CMS discovers a 10 percent error Dual participant must ensure its to use CEHRT throughout PY1 in a in established national base rates; or individual practitioners: manner sufficient to meet the (3) The Secretary determines a cancer (i) Starting in PY1, discuss goals of requirements set forth in type not to be suitable for inclusion in care with each RO beneficiary before § 414.1415(a)(1)(i) of this chapter. the RO Model. initiating treatment and communicate to (c) ICD–10 codes for included cancer the RO beneficiary whether the § 512.225 Beneficiary notification. types. CMS displays on the RO Model treatment intent is curative or palliative; (a) General. Starting in PY1, each website no later than 30 days prior to (ii) Starting in PY1, adhere to Professional participant and Dual each PY the ICD–10 diagnosis codes nationally recognized, evidence-based participant must notify each RO associated with each included cancer clinical treatment guidelines when beneficiary to whom it furnishes type. appropriate in treating RO beneficiaries included RT services— or, alternatively, document in the (1) That the RO participant is § 512.235 Included RT services. medical record the extent of and participating in the RO Model; (a) Only the following RT services rationale for any departure from these (2) That the RO beneficiary has the furnished using an included modality guidelines; opportunity to decline claims data identified at § 512.240 for an included (iii) Starting in PY1, assess each RO sharing for care coordination and cancer type are included RT services beneficiary’s tumor, node, and quality improvement purposes. If an RO that are paid for by CMS under metastasis cancer stage for the CMS- beneficiary declines claims data sharing § 512.265: specified cancer diagnoses; for care coordination and quality (1) Treatment planning; (iv) Starting in PY1, assess the RO improvement purposes, then the RO (2) Technical preparation and special beneficiary’s performance status as a participant must inform CMS within 30 services; quantitative measure determined by the days of receiving notification from the (3) Treatment delivery; and, physician; RO beneficiary that the beneficiary is (4) Treatment management. (v) Starting in PY1, send a treatment declining to have his or her claims data (b) All other RT services furnished by summary to each RO beneficiary’s shared in that manner; and, an RO participant during the Model referring physician within 3 months of (3) Of the RO beneficiary’s cost- performance period are subject to the end of treatment to coordinate care; sharing responsibilities. Medicare FFS payment rules.

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§ 512.240 Included modalities. types in the HOPD setting, creating the (5) Blend. CMS blends each RO The modalities included in the RO RO Model’s national base rates. participant’s historical experience Model are 3-dimensional conformal RT adjustment and the geographically- § 512.255 Determination of participant- adjusted trended national base rate. The (3DCRT), intensity-modulated RT specific professional episode payment and (IMRT), stereotactic radiosurgery (SRS), participant-specific technical episode blend for RO participants with a stereotactic body RT (SBRT), proton payment amounts. professional historical experience beam therapy (PBT), image-guided adjustment or technical historical (a) Thirty days before the start of each radiation therapy (IGRT), and experience adjustment with a value PY, CMS provides each RO participant brachytherapy. equal to or less than zero is 90/10, its case mix and historical experience meaning the calculation of the § 512.245 Included RO episodes. adjustments for both the PC and TC as participant-specific episode payment (a) General. Any RO episode that calculated in paragraphs (c)(3) and (4) of amount is weighted according to 90 begins on or after January 1, 2021, and this section. If an RO participant is not percent of the RO participant’s ends on or before December 31, 2025, is eligible to receive a historical historical experience adjustment and 10 included in the Model performance experience adjustment or case mix percent of the geographically-adjusted period. adjustment as described under trended national base for PY1 through (b) Death or election of hospice paragraph (c)(7) of this section, then PY5. The blend for RO participants with benefit. An RO episode is included in, CMS provides a zero value for those a professional historical experience and paid for under, the RO Model if the adjustments. adjustment or technical historical RO beneficiary dies after the TC of an (b) Any episode used to calculate the experience adjustment of more than RO episode has been initiated, or if the participant-specific professional episode zero is 90/10 in PY1, 85/15 in PY2, 80/ RO beneficiary elects the Medicare payment amounts and the participant- 20 in PY3, 75/25 in PY4, and 70/30 in hospice benefit after the initial specific technical episode payment PY5. treatment planning service, provided amounts for an RO participant is subject (6) Changes in business structure. (i) that the TC is initiated within 28 days to the exclusions described in RO participants must notify CMS in following the initial treatment planning § 512.250(b)(1) and (2). writing of a merger, acquisition, or other service. Each RO participant will (c) CMS calculates the participant- new clinical or business relationship, at receive both installments of the episode specific professional episode payment least 90 days before the date of the payment under such circumstances, amounts and participant-specific change as described in § 424.516. regardless of whether the RO beneficiary technical episode payment amounts for (ii) CMS updates case mix and dies or elects the Medicare hospice each included cancer type using the historical experience adjustments benefit before the relevant course of RT following: according to the relevant treatment treatment has ended. (1) Trend factors. For every PY, CMS history that applies as a result of a (c) Clean periods. An RO episode adjusts the national base rates for the PC merger, acquisition, or other new must not be initiated for the same RO and TC of each cancer type by clinical or business relationship in the beneficiary during a clean period. calculating a separate trend factor for RO participant’s case mix and historical the PC and TC of each included cancer Pricing Methodology experience adjustment calculations from type. the effective date of the change. § 512.250 Determination of national base (2) Geographic adjustment. CMS (7) Adjustments for RO participants rates. adjusts the trended national base rates with fewer than 60 episodes during CMS determines a national base rate prior to applying each RO participant’s 2016–2018. for the PC and TC for each included case mix and historical experience, and (i) RO participants that have fewer cancer type. prior to applying the discounts and than 60 episodes from 2016–2018 do not (a) National base rates are the withholds, for local cost and wage receive a historical experience historical average cost for an episode of indices based on where RT services are adjustment during the Model care for each of the included cancer furnished, as described by existing performance period. types prior to the Model performance geographic adjustment processes in the (ii) RO participants that have fewer period. OPPS and PFS. than 60 episodes from 2016–2018 do not (b) National base rates are determined (3) Case mix adjustment. CMS receive a case mix adjustment for PY1. in the following manner: establishes and applies a case mix (iii) RO participants described in (1) CMS excludes claims from RT adjustment to the national base rate after § 512.255(b)(7)(ii) that continue to have suppliers and RT providers in Maryland the trend factor and geographic fewer than 60 episodes in the rolling 3- and Vermont and all inpatient and ASC adjustment have applied. The case mix year period used to determine the case claims from the construction of episodes adjustment reflects episode or RO mix adjustment for each PY (2017–2019 and; episode characteristics that may be for PY2, 2018–2020 for PY3, 2019–2021 (2) CMS excludes the following: beyond the control of RO participants for PY4, and 2020–2022 for PY5) and (i) episodes with any RT services such as cancer type, age, sex, presence that have never received a case mix furnished by a CAH, of a major procedure, death during the adjustment do not receive a case mix (ii) episodes that are not attributed to episode, and presence of chemotherapy. adjustment for that PY. an RT provider or RT supplier, and (4) Historical experience adjustment. (iv) RO participants that have fewer (iii) episodes in which either the PC CMS establishes and applies a historical than 60 episodes from 2016–2018 and or TC is attributed to an RT provider or experience adjustment to the national were furnishing included RT services in RT supplier with a U.S. Territory base rate after the trend factor, the CBSAs selected for participation on service location. geographic adjustment, and case mix November 30, 2020 are eligible to (3) CMS calculates the episode adjustment have been applied. The receive a stop-loss reconciliation amount CMS paid on average to RT historical experience adjustments reflect amount, if applicable, for the loss providers and RT suppliers for the PC each RO participant’s actual historical incurred under the RO Model as and TC for each of the included cancer experience. described in § 512.285(f).

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(8) Discount factor. CMS deducts a RO Model-specific HCPCS code with an Professional participant or Dual percentage discount from each episode EOE modifier for the PC and TC, except participant. payment after applying the trend factor, as provided in paragraph (c)(12)(iv) (b) Billing under the RO Model. (1) geographic adjustment, and case mix and(v) of this section. Professional participants and Dual and historical experience adjustments to (iv) In the case of incomplete episodes participants must bill an RO Model- the national base rate. The discount (A) The beneficiary coinsurance specific HCPCS code and a SOE factor for the PC is 3.75 percent. The payment equals 20 percent of the FFS modifier to indicate that the treatment discount factor for TC is 4.75 percent. amounts that would have been paid in planning service has been furnished and (9) Incorrect payment withhold. To the absence of the RO Model for the that an RO episode has been initiated. account for duplicate RT services and services furnished by the RO participant (2) Dual participants and Technical incomplete episodes: that initiated the PC and the RO participants must bill an RO Model- (i) CMS withholds from each RO participant that initiated the TC (if specific HCPCS code and SOE modifier participant 1 percent from each episode applicable), except for a subset of to indicate that a treatment delivery payment, after applying the trend factor, incomplete episodes described in service was furnished. geographic adjustment, case mix and paragraph (c)(12)(iv)(B); or (3) RO participants must bill the same historical experience adjustments, and (B) If an RO beneficiary ceases to have RO Model-specific HCPCS code that discount to the national base rate. traditional FFS Medicare as his or her initiated the RO episode and an EOE (ii) CMS determines during the primary payer any time after the initial modifier to indicate that the RO episode annual reconciliation process set forth treatment planning service is furnished has ended. at § 512.285 whether an RO participant and before the date of service on a claim (4) RO participants may submit a is eligible to receive a portion or all of with an RO Model-specific HCPCS code claim with an EOE modifier only after the withheld amount or whether any and EOE modifier, provided a Technical the RT course of treatment has ended, payment is owed to CMS. participant or the same Dual participant except that such claim must not be (10) Quality withhold. In accordance that provided the initial treatment submitted earlier than 28 days after the with § 414.1415(b)(1) of this chapter, planning service furnishes a a technical date of the initial treatment planning CMS withholds 2 percent from each component RT service to the RO service. professional episode payment after beneficiary within 28 days of such (c) Billing for RT services performed applying the trend factor, geographic initial treatment planning service, the during a clean period. RO participants adjustment, case mix and historical beneficiary coinsurance payment equals must bill for any medically necessary experience adjustments, and discount 20 percent of the first installment of the RT services furnished to an RO factor to the national base rate. RO episode payment amount to be paid to beneficiary during a clean period in participants may earn back this the RO participant(s) prior to the accordance with existing FFS billing withhold, in part or in full, based on application of sequestration for the processes in the OPPS and PFS. their AQS. billed RO Model-specific HCPCS code (d) Submission of no-pay claims. RO (11) Patient experience withhold. with an SOE modifier for the PC and Starting in PY3, participants must submit no-pay claims TC. If an RO participant bills the RO for any medically necessary included (i) CMS withholds 1 percent from Model-specific HCPCS code and EOE each technical episode payment after RT services furnished to an RO modifier with a date of service that is beneficiary during an RO episode applying the trend factor, geographic prior to the date that the RO beneficiary adjustment, case mix and historical pursuant to existing FFS billing ceases to have traditional FFS Medicare, processes in the OPPS and PFS. experience adjustments, and discount then the beneficiary coinsurance factor to the national base rate. payment equals 20 percent of the full § 512.265 Payment. (ii) RO participants may earn back episode payment amount for the PC or their patient-experience withhold, in (a) Payment for episodes. CMS pays TC, as applicable. an RO participant for all included RT part or in full, based on their results (v) In the case of duplicate RT from the CAHPS® Cancer Care services furnished to an RO beneficiary services, the beneficiary coinsurance during a completed RO episode as Radiation Therapy survey. payment equals 20 percent of the (12) Coinsurance. RO participants follows: episode payment amount to be paid to may collect beneficiary coinsurance (1) CMS pays a Professional the RO participant(s) per payments for services furnished under participant a participant-specific § 512.255(c)(12)(iii) and 20 percent of the RO Model in multiple installments professional episode payment for the the FFS amount to the RT provider and/ under a payment plan. professional component furnished to an (i) The availability of payment plans or RT supplier furnishing one or more RO beneficiary during an RO episode. may not be used as a marketing tool to duplicate RT services. (2) CMS pays a Technical participant influence beneficiary choice of health (13) Sequestration. CMS deducts 2 a participant-specific technical episode care provider. percent from each episode payment payment for the technical component (ii) RO participants offering a after applying the trend factor, furnished to an RO beneficiary during payment plan may inform the RO geographic adjustment, case mix and an RO episode. beneficiary of the availability of the historical experience adjustments, (3) CMS pays a Dual participant a payment plan prior to or during the discount, withholds, and coinsurance to participant-specific professional episode initial treatment planning session and as the national base rate. payment and a participant-specific necessary thereafter. Billing and Payment technical episode payment for the (iii) The beneficiary coinsurance professional component and technical payment equals 20 percent of the § 512.260 Billing. component furnished to an RO episode payment amount to be paid to (a) Reassignment of billing rights. beneficiary during an RO episode. the RO participant(s) prior to the Each Professional participant and Dual (b) Payment installments. CMS makes application of sequestration for the participant must ensure that its each of the payments described in billed RO Model-specific HCPCS code individual practitioners reassign their paragraph (a) of this section in two with a SOE modifier and for the billed billing rights to the TIN of the equal installments, as follows:

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(1) CMS pays one-half of a RO participant must include the (e) PFS Relativity Adjuster. CMS participant-specific professional episode disclaimer codified at § 512.120(c)(2) on waives the requirement to apply the PFS payment to a Professional participant or the first page of any publicly-released Relativity Adjuster to RO Model-specific Dual participant or one-half of the document, the contents of which APCs for RO participants that are non- participant-specific technical episode materially and substantially references excepted off-campus provider-based payment to a Technical participant or or is materially and substantially based departments (PBDs) identified by Dual participant after the RO participant upon the RO participant’s participation section 603 of the Bipartisan Budget Act bills an RO Model-specific HCPCS code in the RO Model, including but not of 2015 (Pub. L. 114–74), which with a SOE modifier. limited to press releases, journal amended section 1833(t)(1)(B)(v) and (2) CMS pays the remaining half of a articles, research articles, descriptive added paragraph (t)(21) to the Social participant-specific professional episode articles, external reports, and statistical/ Security Act. payment to a Professional participant or analytical materials. (f) General payment waivers. CMS Dual participant or one-half of the (c) Reporting quality measures and waives the following sections of the Act participant-specific technical episode clinical data elements. In addition to solely for the purposes of testing the RO payment to a Technical participant or reporting described in other provisions Model: Dual participant after the RO participant in this part, Professional participants (1) 1833(t)(1)(A). bills an RO Model-specific HCPCS code and Dual participants must report (2) 1833(t)(16)(D). with an EOE modifier. selected quality measures on all patients (3) 1848(a)(1). (c) Duplicate RT services. Duplicate and clinical data elements describing (4) 1833(t)(2)(H). RT services are reimbursed at the FFS cancer stage, disease characteristics, (5) 1869 claims appeals procedures. amount, whether or not the RT provider treatment intent, and specific treatment Reconciliation and Review Process or RT supplier that furnished such plan information on beneficiaries services is an RO participant. treated for specified cancer types, in the § 512.285 Reconciliation process. form, manner, and at a time specified by (a) General. CMS conducts an initial § 512.270 Treatment of add-on payments CMS. reconciliation and a true-up under existing Medicare payment systems. Medicare Program Waivers reconciliation for each RO participant (a) CMS does not make separate for each PY in accordance with this Medicare FFS payments to RO § 512.280 RO Model Medicare program section. participants for any included RT waivers. (b) Annual reconciliation services that are furnished to an RO (a) General. The Secretary may waive calculations. (1) To determine the beneficiary during an RO episode. certain requirements of title XVIII of the reconciliation payment or the (b) An RO participant may receive Act as necessary solely for purposes of repayment amount based on RO Medicare FFS payment for items and testing of the RO Model. Such waivers episodes initiated in a PY, CMS services furnished to an RO beneficiary apply only to the participants in the RO performs the following steps: during an RO episode, provided that Model. (i) CMS calculates an RO participant’s any such other item or service is not an (b) Hospital Outpatient Quality incorrect episode payment included RT service. Reporting (OQR) Program. CMS waives reconciliation amount as described in Data Reporting the application of the Hospital OQR paragraph (c) of this section. Program 2.0 percentage point reduction (ii) CMS calculates the RO § 512.275 Quality measures, clinical data, under section 1833(t)(17) of the Act for participant’s quality reconciliation and reporting. only those Ambulatory Payment amount as described in paragraph (d) of (a) Data privacy compliance. The RO Classifications (APCs) that include only this section, if applicable. participant must— RO Model-specific HCPCS codes during (iii) CMS calculates the RO (1) Comply with all applicable laws the Model performance period. participant’s patient experience pertaining to any patient-identifiable (c) Merit-based Incentive Payment reconciliation amount, as described in data requested from CMS under the System (MIPS). CMS waives the paragraph (e) of this section, if terms of the Innovation Center model, requirement under section 1848(q)(6)(E) applicable. including any patient-identifiable of the Act and § 414.1405(e) of this (iv) CMS calculates the stop-loss derivative data, as well as the terms of chapter to apply the MIPS payment reconciliation amount, as described in any attestation or agreement entered adjustment factor, and, as applicable, paragraph (f) of this section, if into by the RO participant with CMS as the additional MIPS payment applicable. a condition of receiving that data. Such adjustment factor (collectively referred (v) CMS adds, as applicable, the laws may include, without limitation, to as the MIPS payment adjustment incorrect episode payment the privacy and security rules factors) to the TC of RO Model reconciliation amount, any quality promulgated under the Health Insurance payments to the extent that the MIPS reconciliation payment amount, any Portability and Accountability Act of payment adjustment factors would patient experience reconciliation 1996 (HIPAA), as modified, and the otherwise apply to the TC of RO Model amount, and any stop-loss Health Information Technology for payments. reconciliation payment amount. The Economic and Clinical Health Act (d) APM Incentive Payment. CMS sum of these amounts results in a (HITECH). waives the requirements of reconciliation payment or repayment (2) Contractually bind all downstream § 414.1450(b) of this chapter such that amount. recipients of CMS data to the same technical component payment amounts (2) CMS calculations use claims data terms and conditions to which the RO under the RO Model shall not be available at the time of reconciliation. participant was itself bound in its considered in calculation of the (c) Incorrect episode payment agreements with CMS as a condition of aggregate payment amount for covered reconciliation amount. CMS calculates the downstream recipient’s receipt of professional services as defined in the incorrect episode payment the data from the RO participant. section 1848(k)(3)(A) of the Act for the reconciliation amount as follows: (b) RO participant public release of APM Incentive Payment made under (1) Total incorrect payment withhold patient de-identified information. The § 414.1450(b)(1) of this chapter. amount. CMS calculates the total

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incorrect payment withhold amount by amount is the total incorrect episode exceeds 20 percent, either increasing the adding the incorrect payment withhold payment amount. amount of the RO participant’s amount for each episode initiated in the (ii) If the sum described in paragraph reconciliation payment or reducing the PY. (c)(3)(ii)(A) of this section is less than amount of the RO’s participant’s (2) Total duplicate RT services the sum described in paragraph reconciliation repayment. amount. CMS calculates the total (c)(3)(ii)(B) of this section, the difference (g) True-up reconciliation. CMS duplicate RT services amount by adding is added to the total duplicate RT conducts a true-up reconciliation in the all FFS amounts for duplicate RT services amount and the resulting same manner described in paragraph (b) services furnished during each episode amount is the total incorrect episode of this section (except that the quality initiated in the PY. The duplicate RT payment amount. reconciliation payment amount and the services amount is capped for each (5) Incorrect episode payment patient experience reconciliation episode and will not be more than the reconciliation amount. If the total amount are not calculated) to determine participant-specific professional episode incorrect episode payment amount any additional reconciliation payment payment amount or participant-specific represents money owed by the RO or repayment amount that are identified technical episode payment amount participant to CMS, CMS subtracts the using 12-months of claims run-out. received by the RO participant for an total incorrect episode payment amount (h) Reconciliation report. CMS issues RO episode, even if the duplicate RT from the total incorrect payment each RO participant a reconciliation services amount exceeds the withhold amount. In the case that the report for each PY. Each reconciliation participant-specific professional episode total incorrect episode payment amount report contains the following: payment amount or the participant- represents money owed by CMS to the (1) The RO participant’s specific technical episode payment RO participant, CMS adds the total reconciliation payment or repayment amount. incorrect episode payment amount to amount, if any, for the relevant PY. (3) Total incomplete episode amount. the total incorrect payment withhold (2) Any additional reconciliation CMS calculates the total incomplete amount. The resulting amount is the RO payment or repayment amount owed for episode amount for a subset of participant’s incorrect episode payment a previous PY as a result of the true-up incomplete episodes. reconciliation amount. reconciliation. (d) Quality reconciliation payment (i) Incomplete episodes in which an (3) The net reconciliation payment or amount. For Professional participants RO beneficiary ceases to have repayment amount owed. and Dual participants, CMS determines traditional FFS Medicare as his or her (i) Payment of amounts owed. (1) the quality reconciliation payment primary payer at any time after the CMS issues a reconciliation payment to amount for each PY by multiplying the initial treatment planning service is the RO participant in the amount participant’s AQS (as a percentage) by furnished and before the date of service specified in the reconciliation report 30 the total quality withhold amount for all on a claim with an RO Model-specific days after the reconciliation report is RO episodes initiated during the PY. HCPCS code and EOE modifier, deemed final. (e) Patient experience reconciliation (2) The RO participant must pay a provided an RO participant furnishes a amount. For PY3 and subsequent PYs, repayment amount to CMS in the technical component RT service to the CMS determines the patient experience amount specified in the reconciliation RO beneficiary within 28 days of such reconciliation amount for RO report by a deadline specified by CMS. initial treatment planning service, are participants by multiplying the If the RO participant fails to timely pay not included in the incomplete episode participant’s AQS (as a percentage) by the full repayment amount, CMS amount. the total patient experience withhold recoups the repayment amount from any (ii) For all other incomplete episodes amount for all RO episodes initiated payments otherwise owed by CMS to initiated in the PY, CMS determines the during the PY. the RO participant, including Medicare total incomplete episode amount by (f) Stop-loss reconciliation amount. payments for items and services calculating the difference between the CMS determines the stop-loss unrelated to the RO Model. following amounts: reconciliation amount for RO (3) No coinsurance is owed by an RO (A) The sum of all FFS amounts that participants that have fewer than 60 beneficiary with respect to any would have been paid to the RO episodes during 2016 through 2018 and repayment amount or reconciliation participant in the absence of the RO were furnishing included RT services at payment. Model for any included RT services November 30, 2020 in the CBSAs furnished during such incomplete selected for participation by— § 512.290 Timely error notice and episodes, as determined by no-pay (1) Using no-pay claims, CMS reconsideration review process. claims. This sum is what CMS owes the calculates the total FFS amount by (a) Timely error notice. Subject to the RO participant for such incomplete summing the FFS amounts that would limitations on review in § 512.170, an episodes. have been paid to the RO participant in RO participant that identifies and (B) The sum of the participant- the absence of the RO Model for all wishes to contest a suspected error in specific episode payment amounts paid included RT services furnished during the calculation of its reconciliation to the relevant RO participant for such the RO episodes initiated in the PY; and payment or repayment amount or AQS incomplete episodes initiated in the PY. (2) CMS calculates the sum of all must provide written notice of the (4) Total incorrect episode payment participant-specific professional episode suspected calculation error to CMS amount. CMS calculates the total payments and participant-specific within 45 days of the date of the incorrect episode payment amount as technical episode payments paid to the reconciliation report. Such timely error follows: RO participant for the RO episodes notice must be in a form and manner (i) If the sum described in paragraph initiated in the PY. specified by CMS. RO participants are (c)(3)(ii)(A) of this section is more than (3) If the total FFS amount exceeds not permitted to contest the RO Model the sum described in paragraph the sum of the participant-specific pricing methodology or AQS (c)(3)(ii)(B) of this section, the difference episode payment amounts for the PY by methodology. is subtracted from the total duplicate RT more than 20 percent then CMS owes (1) Unless a timely error notice is services amount and the resulting the RO participant the amount that received by CMS within 45 days of the

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date of issuance of a reconciliation (B) Was not involved in the applicable training adjustment, add-on report, the reconciliation payment or responding to the RO participant’s payment amount, outlier payment repayment amount determination timely error notice. amount, transitional drug add-on specified in that reconciliation report is (ii) Notification to the RO participant. payment adjustment (TDAPA) amount, deemed binding and not subject to The CMS-designated reconsideration and transitional add-on payment further review. official makes reasonable efforts to adjustment for new and innovative (2) If CMS receives a timely error notify the RO participant and CMS in equipment and supplies (TPNIES) notice, then CMS responds in writing writing within 15 days of receiving the amount. within 30 days either to confirm that RO participant’s reconsideration review Benchmark Year (BY) means the 12- there was an error in the calculation or request of the following: month period that begins 18 months to verify that the calculation is correct. (A) The issue(s) in dispute; prior to the start of a given measurement CMS may extend the deadline for its (B) The briefing schedule; and year (MY) from which data are used to response upon written notice to the RO (C) The review procedures. construct benchmarks against which to participant. (5) Resolution review. The CMS score an ETC Participant’s achievement reconsideration official makes all (3) Only the RO participant may use and improvement on the home dialysis reasonable efforts to complete the on- the timely error notice process rate and transplant rate for the purpose the-record resolution review and issue a described in this paragraph and the of calculating the ETC Participant’s written determination no later than 60 reconsideration review process MPS. days after the submission of the final described in paragraph (b) of this Clinician Home Dialysis Payment position paper in accordance with the section. Adjustment (Clinician HDPA) means the reconsideration official’s briefing payment adjustment to the MCP for a (b) Reconsideration review. (1) schedule. Reconsideration request by an RO Managing Clinician who is an ETC participant. (i) If the RO participant is Subpart C—ESRD Treatment Choices Participant, for the Managing Clinician’s dissatisfied with CMS’ response to the Model home dialysis claims, as described in timely error notice, then the RO §§ 512.345 and 512.350. participant may request a General Clinician Performance Payment Adjustment (Clinician PPA) means the reconsideration review as specified in § 512.300 Basis and scope. paragraph (b)(2) of this section. payment adjustment to the MCP for a (a) Basis. This subpart implements the (ii) If CMS does not receive a request Managing Clinician who is an ETC test of the End-Stage Renal Disease for reconsideration from the RO Participant based on the Managing (ESRD) Treatment Choices (ETC) Model participant within 10 days of the issue Clinician’s MPS, as described in under section 1115A(b) of the Act. date of CMS’ response to the RO §§ 512.375(b) and 512.380. Except as specifically noted in this participant’s timely error notice, then Comparison Geographic Area(s) subpart, the regulations under this CMS’ response to the timely error notice means those HRRs that are not Selected subpart must not be construed to affect is deemed binding and not subject to Geographic Areas. the applicability of other provisions further review. ESRD Beneficiary means a beneficiary affecting providers and suppliers under who meets either of the following: (2) Submission of a reconsideration Medicare FFS, including the request. (i) Information needed in the (1) Is receiving dialysis or other applicability of provisions regarding services for end-stage renal disease, up reconsideration request. The payment, coverage, or program integrity. reconsideration review request must— to and including the month in which (b) Scope. This subpart sets forth the the beneficiary receives a kidney (A) Provide a detailed explanation of following: transplant up to and including the the basis for the dispute; and (1) The duration of the ETC Model. month in which the beneficiary receives (B) Include supporting documentation (2) The method for selecting ETC a kidney transplant. for the RO participant’s assertion that Participants. (2) Has already received a kidney CMS or its representatives did not (3) The schedule and methodologies transplant and has a non-AKI dialysis or accurately calculate the reconciliation for the Home Dialysis Payment MCP claim— payment or repayment amount or AQS Adjustment and Performance Payment (i) At least 12 months after the in accordance with the terms of this Adjustment. beneficiary’s latest transplant date; or subpart. (4) The methodology for ETC Participant performance assessment for (ii) Less than 12 months after the (3) Form, manner, and deadline for beneficiary’s latest transplant date and submission of the reconsideration purposes of the Performance Payment Adjustment, including beneficiary has a kidney transplant failure diagnosis request. The information specified in code documented on any Medicare paragraph (b)(2)(i) of this section must attribution, benchmarking and scoring, and calculating the Modality claim. be submitted— ESRD facility means an ESRD facility (i) In a form and manner specified by Performance Score. (5) Monitoring and evaluation, as specified in § 413.171 of this chapter. CMS; and ETC Participant means an ESRD (ii) Within 10 days of the date of the including quality measure reporting. (6) Medicare payment waivers. facility or Managing Clinician that is CMS response described in paragraph required to participate in the ETC Model (a)(2) of this section. § 512.310 Definitions. pursuant to § 512.325(a). (4) Designation of and notification For purposes of this subpart, the Facility Home Dialysis Payment from a CMS-designated reconsideration following definitions apply. Adjustment (Facility HDPA) means the official. Adjusted ESRD PPS per Treatment payment adjustment to the Adjusted (i) Designation of reconsideration Base Rate means the per treatment ESRD PPS per Treatment Base Rate for official. CMS designates a payment amount as defined in § 413.230 an ESRD facility that is an ETC reconsideration official who— of this chapter, including patient-level Participant for the ESRD facility’s home (A) Is authorized to receive such adjustments and facility-level dialysis claims, as described in requests; and adjustments, and excluding any §§ 512.340 and 512.350.

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Facility Performance Payment National Provider Identifier (NPI) CMS excludes all U.S. Territories from Adjustment (Facility PPA) means the means the standard unique health the Selected Geographic Areas. payment adjustment to the Adjusted identifier used by health care providers ESRD PPS per treatment base rate for an for billing payors, assigned by the § 512.330 Beneficiary notification. ESRD facility that is an ETC Participant National Plan and Provider (a) General. ETC Participants must based on the ESRD facility’s MPS, as Enumeration System (NPPES) in 45 CFR prominently display informational described in §§ 512.375(a) and 512.380. part 162. materials in each of their office or Home Dialysis Payment Adjustment Performance Payment Adjustment facility locations where beneficiaries (HDPA) means either the Facility HDPA (PPA) means either the Facility PPA or receive treatment to notify beneficiaries or the Clinician HDPA. the Clinician PPA. that the ETC Participant is participating Home dialysis rate means the rate of Performance Payment Adjustment in the ETC Model. CMS provides the ESRD Beneficiaries attributed to the Period (PPA Period) means the six- ETC Participant with a template for ETC Participant who dialyzed at home month period during which a PPA is these materials, indicating the required during the relevant MY, as described in applied in accordance with § 512.380. content that the ETC Participant must § 512.365(b). Pre-emptive LDT Beneficiary means a not change and places where the ETC Hospital referral regions (HRRs) beneficiary who received a kidney Participant may insert its own original means the regional markets for tertiary transplant from a living donor prior to content. The CMS-provided template for medical care derived from Medicare beginning dialysis. the beneficiary notification will include, claims data as defined by the Dartmouth Selected Geographic Area(s) are those without limitation, the following Atlas Project at https:// HRRs selected by CMS pursuant to information: www.dartmouthatlas.org/. § 512.325(b) for purposes of selecting (1) A notification that the ETC Kidney transplant means a kidney ESRD facilities and Managing Clinicians Participant is participating in the ETC transplant, alone or in conjunction with required to participate in the ETC Model Model; any other organ. as ETC Participants. (2) Instructions on how to contact the Living donor transplant (LDT) Subsidiary ESRD facility is an ESRD ESRD Network Organizations with any Beneficiary means an ESRD Beneficiary facility owned in whole or in part by questions or concerns about the ETC who received a kidney transplant from another legal entity. Participant’s participation in the Model; a living donor. Taxpayer Identification Number (TIN) (3) An affirmation of the ESRD Living donor transplant rate means means a Federal taxpayer identification Beneficiary’s protections under the rate of ESRD Beneficiaries and, if number or employer identification Medicare, including the beneficiary’s applicable, Pre-emptive LDT number as defined by the Internal freedom to choose his or her provider or Beneficiaries attributed to the ETC Revenue Service in 26 CFR 301.6109–1. supplier and to select the treatment Participant who received a kidney Transplant rate means the sum of the modality of his or her choice. transplant from a living donor during transplant waitlist rate and the living (b) Applicability of general Innovation the MY, as described in donor transplant rate, as described in Center model provisions. The § 512.365(c)(1)(ii) and § 512.365(c)(2)(ii). § 512.365(c). requirement described in § 512.120(c)(2) Managing Clinician means a Transplant waitlist rate means the shall not apply to the CMS-provided Medicare-enrolled physician or non- rate of ESRD Beneficiaries attributed to materials described in paragraph (a) of physician practitioner, identified by a the ETC Participant who were on the this section. All other ETC Participant National Provider Identifier (NPI), who kidney transplant waitlist during the communications that are descriptive furnishes and bills the MCP for MY, as described in § 512.365(c)(1)(i)– model materials and activities as managing one or more adult ESRD (ii) and § 512.365(c)(2)(i)–(ii). defined under § 512.110 must meet the Beneficiaries. requirements described in § 512.120(c). ESRD Treatment Choices Model Scope Measurement Year (MY) means the and Participants 12-month period for which achievement Home Dialysis Payment Adjustment and improvement on the home dialysis § 512.320 Duration. § 512.340 Payments subject to the Facility rate and transplant rate are assessed for CMS will apply the payment HDPA. the purpose of calculating the ETC adjustments described in this subpart CMS adjusts the Adjusted ESRD PPS Participant’s MPS and corresponding under the ETC Model to claims with per Treatment Base Rate by the Facility PPA. Each MY included in the ETC claim service dates beginning on or after HDPA on claim lines with Type of Bill Model and its corresponding PPA January 1, 2021, and ending on or before 072X, and with condition codes 74 or Period are specified in § 512.355(c). June 30, 2027. 76, when the claim is submitted by an Modality Performance Score (MPS) ESRD facility that is an ETC Participant means the numeric performance score § 512.325 Participant selection and with a claim service date during a calculated for each ETC Participant geographic areas. calendar year subject to adjustment as based on the ETC Participant’s home (a) Selected participants. All described in § 512.350 and the dialysis rate and transplant rate, as Medicare-certified ESRD facilities and beneficiary is at least 18 years old before described in § 512.370(a), which is used Medicare-enrolled Managing Clinicians the first day of the month. to determine the amount of the ETC located in a selected geographic area are Participant’s PPA, as described in required to participate in the ETC § 512.345 Payments subject to the § 512.380. Model. Clinician HDPA. Monthly capitation payment (MCP) (b) Selected Geographic Areas. CMS CMS adjusts the amount otherwise means the monthly capitated payment establishes the Selected Geographic paid under Medicare Part B with respect made for each ESRD Beneficiary to Areas by selecting all HRRs for which at to MCP claims on claim lines with CPT cover all routine professional services least 20 percent of the component zip codes 90965 and 90966 by the Clinician related to treatment of the patient’s codes are located in Maryland, and a HDPA when the claim is submitted by renal condition furnished by the random sample of 30 percent of HRRs, a Managing Clinician who is an ETC physician or non-physician practitioner stratified by Census-defined regions Participant with a claim service date as specified in § 414.314 of this chapter. (Northeast, South, Midwest, and West). during a calendar year subject to

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adjustment as described in § 512.350 (c) Calendar year 2023: +1 percent. (b) Performance Payment Adjustment and the beneficiary is at least 18 years Period. CMS adjusts payments for ETC Performance Payment Adjustment old before the first day of the month. Participants by the PPA during each of § 512.355 Schedule of performance § 512.350 Schedule of home dialysis the PPA Periods, each of which assessment and performance payment payment adjustments. corresponds to a MY. The first PPA adjustment. CMS adjusts the payments specified Period begins on July 1, 2022, and the in § 512.340 by the Facility HDPA and (a) Measurement Years. CMS assesses final PPA Period ends on June 30, 2027. adjusts the payments specified in ETC Participant performance on the (c) Measurement Years and § 512.345 by the Clinician HDPA, home dialysis rate and the transplant Performance Payment Adjustment according to the following schedule: rate during each of the MYs. The first Periods. MYs and PPA Periods follow (a) Calendar year 2021: +3 percent. MY begins on January 1, 2021, and the the following schedule: (b) Calendar year 2022: +2 percent. final MY ends on June 30, 2026.

§ 512.360 Beneficiary population and Pre-emptive LDT Beneficiary to no more (c) Attribution services. (1) ESRD attribution. than one Managing Clinician for a given facility beneficiary attribution. To be (a) General. Except as provided in MY. attributed to an ESRD facility that is an paragraph (b) of this section, CMS (b) Exclusions from attribution. CMS ETC Participant for a month, an ESRD attributes ESRD Beneficiaries to an ETC does not attribute an ESRD Beneficiary Beneficiary must not be excluded based Participant for each month during a MY or Pre-emptive LDT Beneficiary to an on the criteria specified in paragraph (b) based on the ESRD Beneficiary’s receipt ETC Participant for a month if, at any of this section and must have received renal dialysis services during the month of services specified in paragraph (c) of point during the month, the from the ESRD facility. CMS does not this section during that month, for the beneficiary— (1) Is not enrolled in Medicare Part B; attribute Pre-emptive LDT Beneficiaries purpose of assessing the ETC (2) Is enrolled in Medicare Advantage, to ESRD facilities. Participant’s performance on the home a cost plan, or other Medicare managed (i) An ESRD Beneficiary is attributed dialysis rate and transplant rate during care plan; to the ESRD facility at which the ESRD that MY. Except as provided in (3) Does not reside in the United Beneficiary received the plurality of his paragraph (b) of this section, CMS States; or her dialysis treatments in that month, attributes Pre-emptive LDT Beneficiaries (4) Is younger than 18 years of age other than renal dialysis services for to a Managing Clinician for one or more before the first day of the month of the AKI, as identified by claims with Type months during a MY based on the Pre- claim service date; of Bill 072X, with claim service dates at emptive LDT Beneficiary’s receipt of (5) Has elected hospice; the claim header through date during services specified in paragraph (c)(2) of (6) Is receiving dialysis only for any the month. this section during that MY, for the acute kidney injury (AKI); (ii) If the ESRD Beneficiary receives purpose of assessing the Managing (7) Has a diagnosis of dementia at any an equal number of dialysis treatments Clinician’s performance on the living point during the month of the claim from two or more ESRD facilities in a donor transplant rate during that MY. service date or the preceding 12 months, given month, CMS attributes the ESRD CMS attributes ESRD Beneficiaries and, as identified using the most recent Beneficiary to the ESRD facility at if applicable, Pre-emptive LDT dementia-related criteria at the time of which the beneficiary received the Beneficiaries to the ETC Participant for beneficiary attribution, using the CMS– earliest dialysis treatment that month. If each month during a MY retrospectively HCC (Hierarchical Condition Category) the ESRD Beneficiary receives an equal after the end of the MY. CMS attributes Risk Adjustment Model ICD–10–CM number of dialysis treatments from two an ESRD Beneficiary to no more than Mappings; or or more ESRD facilities in a given one ESRD facility and no more than one (8) Is residing in or receiving dialysis month and the ESRD beneficiary Managing Clinician for a given month in a skilled nursing facility (SNF) or received the earliest dialysis treatment during a given MY. CMS attributes a nursing facility. that month from more than one ESRD

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facility, CMS attributes the beneficiary § 512.365 Performance assessment. (iv) The ESRD facility home dialysis to one of the ESRD facilities that (a) General. For each MY, CMS rate is aggregated, as described in furnished the earliest dialysis treatment separately assesses the home dialysis paragraph (e)(1) of this section. that month at random. rate and the transplant rate for each ETC (2) Home dialysis rate for Managing (2) Managing Clinician beneficiary Participant based on the population of Clinicians. (i) The denominator is the attribution. (i) An ESRD beneficiary who ESRD Beneficiaries and, if applicable, total dialysis treatment beneficiary years is not excluded based on the criteria in Pre-emptive LDT Beneficiaries for attributed ESRD Beneficiaries during paragraph (b) of this section is attributed attributed to the ETC Participant under the MY. Dialysis treatment beneficiary to a Managing Clinician who is an ETC § 512.360. Information used to calculate years included in the denominator are Participant for a month if that Managing the home dialysis rate and the composed of those months during Clinician submitted an MCP claim for transplant rate includes Medicare which an attributed ESRD Beneficiary services furnished to the beneficiary, claims data, Medicare administrative received maintenance dialysis at home identified with CPT codes 90957, 90958, data, and data from the Scientific or in an ESRD facility, such that one 90959, 90960, 90961, 90962, 90965, or Registry of Transplant Recipients. beneficiary year is comprised of 12 90966, with claim service dates at the beneficiary months. Months during claim line through date during the (b) Home dialysis rate. CMS calculates which an attributed ESRD Beneficiary month. the home dialysis rate for ESRD received maintenance dialysis are (A) If more than one Managing facilities and Managing Clinicians as identified by claims with CPT codes Clinician submits a claim for the MCP follows. 90957, 90958, 90959, 90960, 90961, furnished to a single ESRD Beneficiary (1) Home dialysis rate for ESRD 90962, 90965, or 90966. with a claim service date at the claim facilities. (i) The denominator is the (ii) The numerator is the total number line during the month, the ESRD total dialysis treatment beneficiary years of home dialysis treatment beneficiary Beneficiary is attributed to the for attributed ESRD Beneficiaries during years for attributed ESRD Beneficiaries Managing Clinician associated with the the MY. Dialysis treatment beneficiary during the MY plus one half the total earliest claim service date at the claim years included in the denominator are number of self dialysis treatment line through date during the month. composed of those months during beneficiary years. (B) If more than one Managing which an attributed ESRD Beneficiary (A) Home dialysis treatment Clinician submits a claim for the MCP received maintenance dialysis at home beneficiary years included in the furnished to a single ESRD Beneficiary or in an ESRD facility, such that one numerator are composed of those with the same earliest claim service date beneficiary year is composed of 12 months during which an attributed at the claim line through date for the beneficiary months. Months during ESRD Beneficiary received maintenance month, the ESRD Beneficiary is which attributed ESRD Beneficiaries dialysis at home, such that one randomly attributed to one of these received maintenance dialysis are beneficiary year is comprised of 12 Managing Clinicians. identified by claims with Type of Bill beneficiary months. Months in which an (ii) A Pre-emptive LDT Beneficiary 072X. attributed ESRD Beneficiary received who is not excluded based on the (ii) The numerator is the total number maintenance dialysis at home are criteria in paragraph (b) of this section of home dialysis treatment beneficiary identified by claims with CPT codes is attributed to the Managing Clinician years plus one half the total number of 90965 or 90966. with whom the beneficiary has had the self dialysis treatment beneficiary years (B) Self-dialysis treatment beneficiary most claims between the start of the MY for attributed ESRD Beneficiaries during years included in the numerator are and the month in which the beneficiary the MY. composed of those months during received the transplant for all months (A) Home dialysis treatment which an attributed ESRD Beneficiary between the start of the MY and the beneficiary years included in the received self dialysis in center, such month of the transplant. that one beneficiary year is comprised of (A) If no Managing Clinician has had numerator are composed of those months during which attributed ESRD 12 beneficiary months. Months in which the plurality of claims for a given Pre- an attributed ESRD Beneficiary received emptive LDT Beneficiary such that Beneficiaries received maintenance dialysis at home, such that one self dialysis are identified by claims multiple Managing Clinicians each had with Type of Bill 072X and condition the same number of claims for that beneficiary year is comprised of 12 beneficiary months. Months in which an code 72. beneficiary during the MY, the Pre- (iii) Information used to calculate the emptive LDT Beneficiary is attributed to attributed ESRD Beneficiary received maintenance dialysis at home are Managing Clinician home dialysis rate the Managing Clinician associated with includes Medicare claims data and the latest claim service date at the claim identified by claims with Type of Bill 072X and condition codes 74 or 76. Medicare administrative data. line through date during the MY up to (iv) The Managing Clinician home and including the month of the (B) Self dialysis treatment beneficiary dialysis rate is aggregated, as described transplant. years included in the numerator are in paragraph (e)(2) of this section. (B) If no Managing Clinician had the composed of those months during (c) Transplant rate. CMS calculates plurality of claims for a given Pre- which attributed ESRD Beneficiaries the transplant rate for ETC Participants emptive LDT Beneficiary such that received self dialysis in center, such as follows. multiple Managing Clinicians each had that one beneficiary year is comprised of (1) Transplant rate for ESRD facilities. the same number of services for that 12 beneficiary months. Months in which The transplant rate for ESRD facilities is beneficiary during the MY, and more an attributed ESRD Beneficiary received the sum of the transplant waitlist rate than one of those Managing Clinicians self dialysis are identified by claims for ESRD facilities, as described in had the latest claim service date at the with Type of Bill 072X and condition paragraph (c)(1)(i) of this section, and claim line through date during the MY code 72. the living donor transplant rate for up to and including the month of the (iii) Information used to calculate the ESRD facilities, as described in transplant, the Pre-emptive LDT ESRD facility home dialysis rate paragraph (c)(1)(ii) of this section. Beneficiary is randomly attributed to includes Medicare claims data and (i) Transplant waitlist rate for ESRD one of these Managing Clinicians. Medicare administrative data. facilities. (A) The denominator is the

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total dialysis treatment beneficiary years Clinicians, as described in paragraph years for LDT Beneficiaries during the for attributed ESRD Beneficiaries during (c)(2)(ii) of this section. MY and the total number of attributed the MY. Dialysis treatment beneficiary (i) Transplant waitlist rate for beneficiary years for Pre-emptive LDT years included in the denominator are Managing Clinicians. (A) The Beneficiaries during the MY. composed of those months during denominator is the total dialysis (1) Beneficiary years for LDT which an attributed ESRD beneficiary treatment beneficiary years for Beneficiaries included in the numerator received maintenance dialysis at home attributed ESRD Beneficiaries during the are composed of those months during or in an ESRD facility, such that one MY. Dialysis treatment beneficiary years which an LDT Beneficiary is attributed beneficiary year is comprised of 12 included in the denominator are to a Managing Clinician, from the beneficiary months. Months during composed of those months during beginning of the MY up to and which an attributed ESRD Beneficiary which an attributed ESRD Beneficiary including the month of the transplant. received maintenance dialysis are received maintenance dialysis at home LDT Beneficiaries are identified using identified by claims with Type of Bill or in an ESRD facility, such that one information about living donor 072X, excluding claims for beneficiaries beneficiary year is comprised of 12 transplants from the SRTR Database and who were 75 years of age or older at any beneficiary months. Months during Medicare claims data. point during the month. which an attributed ESRD Beneficiary (2) Beneficiary years for Pre-emptive (B) The numerator is the total number received maintenance dialysis are LDT Beneficiaries included in the of attributed beneficiary years for which identified by claims with CPT codes numerator are composed of those attributed ESRD Beneficiaries were on 90957, 90958, 90959, 90960, 90961, months during which a Pre-emptive the kidney transplant waitlist. Months 90962, 90965, or 90966, excluding LDT Beneficiary is attributed to a during which an attributed ESRD claims for beneficiaries who were 75 Managing Clinician, from the beginning Beneficiary was on the kidney years of age or older at any point during of the MY up to and including the transplant waitlist are identified using the month. month of the transplant. Pre-emptive data from the SRTR database. (B) The numerator is the total number LDT Beneficiaries are identified using (ii) Living donor transplant rate for of attributed beneficiary years for which information about living donor ESRD facilities. (A) The denominator is attributed ESRD Beneficiaries were on transplants from the SRTR Database and the total dialysis treatment beneficiary the kidney transplant waitlist. Months Medicare claims data. years for attributed ESRD Beneficiaries during which an attributed ESRD (iii) The Managing Clinician during the MY. Dialysis treatment Beneficiary was on the kidney transplant waitlist rate is risk adjusted, beneficiary years included in the transplant waitlist are identified using as described in paragraph (d) of this denominator are composed of those data from the SRTR database. section. The Managing Clinician months during which an attributed (ii) Living donor transplant rate for transplant rate is aggregated, as ESRD Beneficiary received maintenance Managing Clinicians. (A) The described in paragraph (e)(2) of this dialysis at home or in an ESRD facility, denominator is the sum of the total section. such that one beneficiary year is dialysis treatment beneficiary years for (d) Risk adjustment. (1) CMS risk comprised of 12 beneficiary months. attributed ESRD Beneficiaries during the adjusts the transplant waitlist rate based Months during which an attributed MY and the total Pre-emptive LDT on beneficiary age with separate risk ESRD Beneficiary received maintenance beneficiary years for attributed coefficients for the following age dialysis are identified by claims with beneficiaries during the MY. categories of beneficiaries, with age Type of Bill 072X, excluding claims for (1) Dialysis treatment beneficiary computed on the last day of each month beneficiaries who were 75 years of age years included in the denominator are of the MY: or older at any point during the month. composed of those months during (i) 18 to 55. (B) The numerator is the total number which an attributed ESRD Beneficiary (ii) 56 to 70. of attributed beneficiary years for LDT received maintenance dialysis at home (iii) 71 to 74. Beneficiaries during the MY. or in an ESRD facility, such that one (2) CMS risk adjusts the transplant Beneficiary years for LDT Beneficiaries beneficiary year is comprised of 12 waitlist rate to account for the relative included in the numerator are beneficiary months. Months during percentage of the population of composed of those months between the which an attributed ESRD Beneficiary beneficiaries attributed to the ETC beginning of the MY up to and received maintenance dialysis are Participant in each age category relative including the month of the transplant identified by claims with CPT codes to the national age distribution of for LDT Beneficiaries attributed to an 90957, 90958, 90959, 90960, 90961, beneficiaries not excluded from ESRD facility during the month of the 90962, 90965, or 90966, excluding attribution. transplant. LDT Beneficiaries are claims for beneficiaries who were 75 (e) Aggregation. (1) Aggregation for identified using information about years of age or older at any point during ESRD facilities. An ESRD facility’s living donor transplants from the SRTR the month. home dialysis rate and transplant rate Database and Medicare claims data. (2) Pre-emptive LDT beneficiary years are aggregated to the ESRD facility’s (iii) The ESRD facility transplant included in the denominator are aggregation group. The aggregation waitlist rate is risk adjusted, as composed of those months during group for a Subsidiary ESRD facility described in paragraph (d) of this which a Pre-emptive LDT Beneficiary is includes all ESRD facilities owned in section. The ESRD facility transplant attributed to a Managing Clinician, from whole or in part by the same legal entity rate is aggregated, as described in the beginning of the MY up to and located in the HRR in which the ESRD paragraph (e)(1) of this section. including the month of the living donor facility is located. An ESRD facility that (2) Transplant rate for Managing transplant. Pre-emptive LDT is not a Subsidiary ESRD facility is not Clinicians. The transplant rate for Beneficiaries are identified using included in an aggregation group. Managing Clinicians is the sum of the information about living donor (2) Aggregation for Managing transplant waitlist rate for Managing transplants from the SRTR Database and Clinicians. A Managing Clinician’s Clinicians, as described in paragraph Medicare claims data. home dialysis rate and transplant rate (c)(2)(i) of this section, and the living (B) The numerator is the sum of the are aggregated to the Managing donor transplant rate for Managing total number of attributed beneficiary Clinician’s aggregation group. The

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aggregation group for a Managing (2) 75th+ Percentile of benchmark the home dialysis rate constitutes 2⁄3 of Clinician who is— rates for comparison geographic areas the MPS and the ETC Participant’s score (i) In a group practice is the practice during the benchmark year: 1.5 points. for the transplant rate constitutes 1⁄3 of group level, as identified by practice (3) 50th+ Percentile of benchmark the MPS. CMS uses the following TIN; or rates for comparison geographic areas formula to calculate the ETC (ii) A solo practitioner is the during the benchmark year: 1 point. Participant’s MPS: individual clinician level, as identified (4) 30th+ Percentile of benchmark Modality Performance Score = 2 × by NPI. rates for comparison geographic areas (Higher of the home dialysis during the benchmark year: 0.5 points. § 512.370 Benchmarking and scoring. achievement or improvement score) (5) <30th Percentile of benchmark + (Higher of the transplant (a) General. (1) CMS assesses the rates for comparison geographic areas achievement or improvement score) home dialysis rate and transplant rate during the benchmark year: 0 points. for each ETC Participant against the (c) Improvement scoring. CMS § 512.375 Payments subject to adjustment. applicable benchmarks to calculate an— assesses ETC Participant improvement (a) Facility PPA. CMS adjusts the (i) Achievement score, as described in on the home dialysis rate and transplant Adjusted ESRD PPS per Treatment Base paragraph (b) of this section; and rate against benchmarks constructed Rate by the Facility PPA on claim lines (ii) Improvement score, as described based on the ETC Participant’s with Type of Bill 072X, when the claim in paragraph (c) of this section. aggregation group’s historical is submitted by an ETC Participant that (2)(i) CMS calculates the ETC performance on the home dialysis rate is an ESRD facility and the beneficiary Participant’s MPS as the weighted sum and transplant rate during the is at least 18 years old before the first of the higher of the achievement score Benchmark Year. CMS uses the day of the month, on claims with claim or the improvement score for the ETC following scoring methodology to assess service dates during the applicable PPA Participant’s home dialysis rate and an ETC Participant’s improvement Period as described in § 512.355(c). transplant rate, as described in score. (b) Clinician PPA. CMS adjusts the paragraph (d) of this section. (1) Greater than 10 percent amount otherwise paid under Medicare (ii) The ETC Participant’s MPS improvement relative to the Benchmark Part B with respect to MCP claims on determines the ETC Participant’s PPA, Year rate: 1.5 points. claim lines with CPT codes 90957, as described in § 512.380. (2) Greater than 5 percent 90958, 90959, 90960, 90961, 90962, (b) Achievement scoring. CMS improvement relative to the Benchmark 90965 and 90966 by the Clinician PPA assesses ETC Participant performance at Year rate: 1 point. when the claim is submitted by an ETC the aggregation group level on the home (3) Greater than 0 percent Participant who is a Managing Clinician dialysis rate and transplant rate against improvement relative to the Benchmark and the beneficiary is at least 18 years benchmarks constructed based on the Year rate: 0.5 points. old before the first day of the month, on home dialysis rate and transplant rate (4) Less than or equal to the claims with claim service dates during among aggregation groups of ESRD Benchmark Year rate: 0 points. the applicable PPA Period as described facilities and Managing Clinicians (d) Modality Performance Score. CMS in § 512.355(c). located in Comparison Geographic calculates the ETC Participant’s MPS as Areas during the Benchmark Year. CMS the higher of ETC Participant’s § 512.380 PPA Amounts and schedules. uses the following scoring methodology achievement score or improvement CMS adjusts the payments described to assess an ETC Participant’s score for the home dialysis rate, together in § 512.375 based on the ETC achievement score. with the higher of the ETC Participant’s Participant’s MPS calculated as (1) 90th+ Percentile of benchmark achievement score or improvement described in § 512.370(d) according to rates for comparison geographic areas score for the transplant rate, weighted the following amounts and schedules in during the benchmark year: 2 points. such that the ETC Participant’s score for Table 1 and Table 2 to § 512.380.

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§ 512.385 PPA exclusions. not be submitted in regards to: The resulting discrepancy in payment that (a) ESRD facilities. CMS excludes an methodology used to determine the arises from the application of an aggregation group (as described in MPS; or the establishment of the home incorrect PPA in a time and manner § 512.365(e)(1) of Subsidiary ESRD dialysis rate methodology, transplant determined by CMS. facilities with fewer than 11 attributed rate methodology, achievement and (5) Decisions based on targeted review ESRD beneficiary years during an MY improvement benchmarks and are final, and there is no further review from the applicability of the Facility benchmarking methodology, or PPA or appeal. PPA for the corresponding PPA Period. amounts. The process for targeted Quality Monitoring CMS excludes ESRD facilities that are reviews is as follows: not Subsidiary ESRD facilities with (1) An ETC Participant has 90 days (or § 512.395 Quality measures. fewer than 11 attributed ESRD a later date specified by CMS) to submit CMS collects data on these two beneficiary years during an MY from the a request for a targeted review, which quality measures for ESRD facilities that applicability of the Facility PPA for the begins on the day CMS makes available are ETC Participants to monitor for corresponding PPA Period. the MPS. changes in quality outcomes. CMS (b) Managing Clinicians. CMS (2) CMS will respond to each request conducts data collection and measure excludes an aggregation group (as for targeted review timely submitted calculation using claims data and other described in § 512.365(e)(2)) of and determine whether a targeted Medicare administrative data, including Managing Clinicians with fewer than 11 review is warranted. enrollment data: attributed ESRD beneficiary years (3) The ETC Participant may include (a) Standardized Mortality Ratio during an MY from the applicability of additional information in support of the (SMR); NQF #0369. the Clinician PPA for the corresponding request for targeted review at the time (b) Standardized Hospitalization Ratio PPA Period. the request is submitted. If CMS (SHR); NQF #1463. requests additional information from the Medicare Program Waivers § 512.390 Notification and targeted review. ETC Participant, it must be provided (a) Notification. CMS will notify each and received within 30 days of the § 512.397 ETC Model Medicare program ETC Participant, in a form and manner request. Non-responsiveness to the waivers. determined by CMS, of the ETC request for additional information may The following provisions are waived Participant’s attributed beneficiaries, result in the closure of the targeted solely for purposes of testing the ETC MPS, and PPA for a PPA Period no later review request. Model. than one month before the start of the (4) If, upon completion of a targeted (a)(1) Medicare payment waivers. applicable PPA Period. review, CMS finds that there was an CMS waives the requirements of (b) Targeted review process. An ETC error in the calculation of the ETC sections 1833(a), 1833(b), 1848(a)(1), Participant may request a targeted Participant’s MPS such that an incorrect 1881(b), and 1881(h)(1)(A) of the Act review of the calculation of the MPS. PPA has been applied during the PPA only to the extent necessary to make the Requests for targeted review are limited period, CMS shall notify the ETC payment adjustments under the ETC to the calculation of the MPS, and may Participant and must resolve any Model described in this subpart.

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(2) Beneficiary cost sharing. The clinical nurse specialist, licensed social (4) CMS waives the requirement that payment adjustments under the ETC worker, nurse practitioner, physician an outcomes assessment designed to Model described in this subpart do not assistant, registered dietician/nutrition measure beneficiary knowledge about affect the beneficiary cost-sharing professional, or a clinic/group practice. chronic kidney disease and its treatment amounts for Part B services furnished by (2) CMS waives the requirement that be performed by a qualified clinician as ETC Participants under the ETC Model. the KDE is covered only for Stage IV part of one of the KDE sessions under (b) CMS waives the following chronic kidney disease (CKD) patients § 410.48(d)(5)(iii) of this chapter, requirements of title XVIII of the Act under section 1861(ggg)(1)(A) of the Act provided that such outcomes solely for purposes of testing the ETC and § 410.48(b)(1) of this chapter to assessment is performed within 1 month Model: permit beneficiaries diagnosed with of the final KDE session by qualified (1) CMS waives the requirement CKD Stage V or within the first 6 staff. under section 1861(ggg)(2)(A)(i) of the months of starting dialysis to receive the Dated: September 4, 2020. Act and § 410.48(a) and (c)(2)(i) of this KDE benefit. Seema Verma, chapter that only doctors, physician (3) CMS waives the requirement that assistants, nurse practitioners, and the content of the KDE sessions include Administrator, Centers for Medicare & Medicaid Services. clinical nurse specialists can furnish the management of co-morbidities, KDE services to allow KDE services to including delaying the need for dialysis, Dated: September 9, 2020. be provided by clinical staff under the under § 410.48(d)(1) of this chapter Alex M. Azar II, direction of and incident to the services when such services are furnished to Secretary, Department of Health and Human of the Managing Clinician who is an beneficiaries with CKD Stage V or Services. ETC Participant. The KDE benefit must ESRD, unless such content is relevant [FR Doc. 2020–20907 Filed 9–21–20; 11:15 am] be furnished and billed by a Physician, for the beneficiary. BILLING CODE 4120–01–P

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