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DEPARTMENT OF HEALTH AND claims in the initial 3 years of the ETC website as soon as possible after they HUMAN SERVICES Model. have been received: http:// We believe that these two proposed www.regulations.gov. Follow the search Centers for Medicare & Medicaid models would test ways to further our instructions on that website to view Services goals of reducing Medicare expenditures public comments. while preserving or enhancing the 42 CFR Part 512 quality of care furnished to Electronic Access beneficiaries. This Federal Register document is [CMS–5527–P] DATES: Comment period: To be assured also available from the Federal Register consideration, comments must be online database through Federal Digital RIN 0938–AT89 received at one of the addresses System (FDsys), a service of the U.S. Medicare Program; Specialty Care provided below, no later than 5 p.m. Government Publishing Office. This Models To Improve Quality of Care and Eastern Standard Time on September database can be accessed via the Reduce Expenditures 16, 2019. internet at http://www.gpo.gov/fdsys/. ADDRESSES: In commenting, please refer Current Procedural Terminology (CPT) AGENCY: Centers for Medicare & to file code CMS–5527–P. Because of Copyright Notice Medicaid Services (CMS), HHS. staff and resource limitations, we cannot ACTION: Proposed rule. accept comments by facsimile (FAX) Throughout this proposed rule, we transmission. use CPT® codes and descriptions to SUMMARY: This proposed rule proposes Comments, including mass comment refer to a variety of services. We note to implement two new mandatory submissions, must be submitted in one that CPT® codes and descriptions are Medicare payment models under of the following three ways (please copyright 2019 American Medical section 1115A of the Social Security choose only one of the ways listed): Association. All Rights Reserved. CPT® Act—the Radiation Oncology Model 1. Electronically. You may submit is a registered trademark of the (RO Model) and the End-Stage Renal electronic comments on this regulation American Medical Association (AMA). Disease (ESRD) Treatment Choices to http://www.regulations.gov. Follow Applicable Federal Acquisition Model (ETC Model). The proposed RO the ‘‘Submit a comment’’ instructions. Regulations (FAR) and Defense Federal Model would promote quality and 2. By regular mail. You may mail Acquisition Regulations (DFAR) apply. financial accountability for providers written comments to the following and suppliers of radiotherapy (RT). The address ONLY: Centers for Medicare & I. Executive Summary RO Model would test whether making Medicaid Services, Department of A. Purpose prospective episode payments to Health and Human Services, Attention: hospital outpatient departments (HOPD) CMS–5527–P, P.O. Box 8013, Baltimore, The purpose of this proposed rule is and freestanding radiation therapy MD 21244–1850. to propose the implementation and centers for RT episodes of care preserves Please allow sufficient time for mailed testing of two new mandatory models or enhances the quality of care comments to be received before the under the authority of the Innovation furnished to Medicare beneficiaries close of the comment period. Center, as well as to propose certain while reducing Medicare program 3. By express or overnight mail. You general provisions that would be spending through enhanced financial may send written comments to the applicable to both the RO Model and the accountability for RO Model following address ONLY: Centers for ETC Model. Section 1115A of the Social participants. The proposed ETC Model Medicare & Medicaid Services, Security Act (the Act) authorizes the would be a mandatory payment model Department of Health and Human Innovation Center to test innovative focused on encouraging greater use of Services, Attention: CMS–5527–P, Mail payment and service delivery models home dialysis and kidney transplants, Stop C4–26–05, 7500 Security expected to reduce Medicare, Medicaid, in order to preserve or enhance the Boulevard, Baltimore, MD 21244–8013. and Children’s Health Insurance quality of care furnished to Medicare For information on viewing public Program (CHIP) expenditures while beneficiaries while reducing Medicare comments, see the beginning of the preserving or enhancing the quality of expenditures. The ETC Model would SUPPLEMENTARY INFORMATION section. care furnished to the beneficiaries of include ESRD facilities and certain FOR FURTHER INFORMATION CONTACT: such programs. Under the Medicare fee- clinicians caring for beneficiaries with Rebecca Cole (410) 786–1589. for-service (FFS) program, Medicare ESRD—or Managing Clinicians—located [email protected], for questions generally makes a separate payment to in selected geographic areas as related to General Provisions. providers and suppliers for each item or participants. CMS would assess the [email protected], for service furnished to a beneficiary during performance of participating Managing questions related to the Radiation the course of treatment. Because the Clinicians and ESRD facilities on their Oncology Model. ETC- amount of payments received by a rates of home dialysis and kidney and [email protected], for questions provider or supplier for such items and kidney-pancreas transplants during each related to the ESRD Treatment Choices services varies with the volume of items Measurement Year (MY), and would Model. and services furnished to a beneficiary, subsequently adjust certain of their SUPPLEMENTARY INFORMATION: some providers and suppliers may be Medicare payments upward or Inspection of Public Comments: All financially incentivized to downward during the corresponding comments received before the close of inappropriately increase the volume of performance payment adjustment the comment period are available for items and services to receive higher period based on their home dialysis rate viewing by the public, including any payments. Medicare FFS may also and transplant rate. CMS would also personally identifiable or confidential detract from a provider’s or supplier’s positively adjust certain Medicare business information that is included in incentive to invest in quality payments to participating ESRD a comment. We post all comments improvement and care coordination facilities and Managing Clinicians for received before the close of the activities if it means those activities will home dialysis and home dialysis-related comment period on the following result in a lower volume of items and

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services. As a result, care may be would result in a robust data set for Medicare expenditures while preserving fragmented, unnecessary, or duplicative. evaluating the models’ proposed or enhancing the quality of care for The goal for the proposed models is payment approaches and would Medicare beneficiaries. We anticipate to preserve or enhance the quality of stimulate the rapid development of new the proposed RO Model would benefit care furnished to beneficiaries while evidence-based knowledge. Testing the Medicare beneficiaries by encouraging reducing program spending through proposed models in this manner would more efficient care delivery and enhanced financial accountability for also allow us to learn more about incentivizing higher value care across model participants. We propose that the patterns of inefficient utilization of episodes of care. We propose that the performance period of the proposed RO health care services and how to RO Model would have a performance Model would begin in 2020, and end incentivize quality improvement for period of five calendar years, beginning December 31, 2024. We propose to beneficiaries receiving services for RT in 2020, and ending December 31, 2024. implement the proposed payment and ESRD, which could inform future We propose to test the RO Model to adjustments under the proposed ETC model design. capture all episodes that finish within Model over the course of 6 and a half We seek public comment on the the performance period, which means years, beginning January 1, 2020, and proposals contained in this proposed that the data collection, episode ending June 30, 2026. rule, and also on any alternatives payments, and reconciliation would The proposed models would offer considered. continue into calendar year 2025. participants the opportunity to examine and better understand their own care B. Summary of the Major Proposed a. Summary of Major Provisions processes and patterns with regard to Provisions (1) Proposed RO Model Overview beneficiaries receiving RT services for 1. General Provisions cancer, and beneficiaries with ESRD, RT is a common treatment for patients respectively. We chose these focus areas The proposed general provisions undergoing cancer treatment and is for the proposed models because, as would be applicable only to participants typically furnished by a physician at discussed in depth in sections III and IV in the RO Model and the ETC Model. either a HOPD or a freestanding of this proposed rule, we believe that We have identified the proposed general radiation therapy center. We are participants in these models would have provisions based on standardized proposing the RO Model to include significant opportunity to redesign care parameters that have been repeatedly prospective payments for certain RT and improve the quality of care memorialized in various documents services furnished during a 90-day furnished to beneficiaries receiving governing participation in existing episode for included cancer types for these services. model tests and propose to make them certain Medicare beneficiaries. The We believe the proposed models applicable to both proposed models so included cancer types would be would further the agency’s goal of that we may eliminate repetition in the determined by the following criteria: all increasing the extent to which CMS proposed 42 CFR part 512. The are commonly treated with radiation; initiatives pay for value and outcomes, proposed general provisions address make up the majority of all incidence of rather than for volume of services alone, beneficiary protections, model cancer types; and have demonstrated by promoting the alignment of financial evaluation and monitoring, audits and pricing stability. (See section III.C.5.a of and other incentives for health care record retention, monitoring and this proposed rule for more providers caring for beneficiaries compliance, remedial or administrative information.) This model would not receiving treatment for cancer or ESRD. action, model termination by CMS, account for total cost of all care Payments that are made to health care limitations on review, and provided to the beneficiary during the providers for assuming financial miscellaneous provisions on bankruptcy 90 days of an episode. Rather, the accountability for the cost and quality of and other notifications. These payment would cover only select RT care create incentives for the provisions are not intended to services furnished during an episode. implementation of care redesign among comprehensively encompass all the Episode payments would be split into model participants and other providers provisions that would apply to each two components—the professional and suppliers. model. Both the RO Model and the ETC component (PC) and the technical CMS is testing several models, Model have unique aspects that would component (TC). This division reflects including voluntary models focused require additional, more tailored the fact that RT professional and specifically on cancer and ESRD. The provisions, including with respect to technical services are sometimes proposed RO and ETC Models would payment and quality measurement. furnished by separate providers and require the participation of providers Such model-specific provisions are suppliers and paid for through different and suppliers that might not otherwise described elsewhere in this proposed payment systems (namely, the Medicare participate in these models, and would rule. Physician Fee Schedule and Outpatient be tested in multiple geographic areas. Prospective Payment System). The proposed models would allow 2. Model Overview—Proposed For example, under the RO Model, a CMS to test models with provider and Radiation Oncology Model participating HOPD would have at least supplier participation when there are In this proposed rule, we propose the one PGP to furnish RT services at the differences in: (1) Historic care and creation and testing of a new payment HOPD. A PGP would furnish the PC as utilization patterns; (2) patient model for radiation oncology, the RO a professional participant and a HOPD populations and care patterns; (3) roles Model. The intent of the proposed RO would furnish the TC as a technical within their local markets; (4) volume of Model is to promote quality and participant. Both would be participants services; (5) levels of access to financial, financial accountability for episodes of in the RO Model, furnishing separate community, or other resources; and (6) care centered on RT services. The RO components of the same episode. A levels of population and health care Model would test whether prospective participant may also elect to furnish provider density. We believe that episode-based payments to physician both the PC and TC as a Dual participation in the proposed models by group practices (PGPs), HOPDs, and participant through one entity, such as a large number of providers and freestanding radiation therapy centers a freestanding radiation therapy center. suppliers with diverse characteristics for RT episodes of care would reduce The proposed RO Model would test the

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cost-saving potential of prospective organization level, such as where a These measures would be applicable to episode payments for certain RT radiation oncologist or his or her PGP the full range of proposed included services furnished during a 90-day participates in multiple Innovation cancer types and provide us the ability episode and whether shorter courses of Center models. We believe that the RO to accurately measure changes or RT (that is, fewer doses, also known as Model is compatible with existing improvements in the quality of RT fractions) would encourage more models and programs that provide services. Further, we believe that these efficient care delivery and incentivize opportunities to improve care and measures would allow the RO Model to higher value care. reduce spending, especially episode apply a pay-for-performance payment models like the Oncology Care methodology that incorporates (2) Model Scope Model. However, we would work to performance measurement with a focus We propose criteria for the types of resolve any potential overlaps between on clinical care and beneficiary cancer included under the RO Model the RO Model and other CMS models or experience with the aim of identifying and list 17 cancer types that meet our programs that could result in repetitive a reduction in expenditures with proposed criteria. These cancer types services, or duplicative payment of preserved or enhanced quality of care are commonly treated with RT and, services, and duplicative counting of for beneficiaries. therefore, RT services for such cancer savings or other reductions in We propose that RO participants types can be accurately priced for expenditures. would be paid for reporting clinical data purposes of a prospective episode in accordance with our proposed (4) Episodes and Episode Pricing payment model. RO Model episodes reporting requirements as discussed in Methodology would include most RT services section III.C.8.e, and paid for furnished in HOPDs and freestanding We propose to set a separate payment performance on aggregated quality radiation therapy centers during a 90- amount for the PC and the TC of each measure data on three proposed quality day episode. of the cancer types included in the RO measures and pay-for-reporting on one We propose that participation in the Model. The payment amounts would be proposed quality measure (for PY1 and RO Model be mandatory for all RT determined based on proposed national PY2) as discussed in section III.C.8.f. By providers and suppliers within selected base rates, trend factors, and PY3, we plan to propose to add a set of geographic areas. We propose to use adjustments for each participant’s case- patient experience measures via Core Based Statistical Areas (CBSAs) mix, historical experience, and rulemaking based on the CAHPS® delineated by the Office of Management geographic location. The payment Cancer Care Survey for Radiation and Budget 1 as the geographic area for amount would also be adjusted for Therapy for inclusion as pay-for- the randomized selection of RO withholds for incomplete episodes, performance measures. We would also participants. We would link RT quality, and starting in performance require Professional participants and providers and RT suppliers to a CBSA year (PY) 3 beneficiary experience. The Dual participants to report all quality by using the five digit ZIP Code of the standard beneficiary coinsurance data for all applicable patients receiving location where RT services are amounts (typically 20 percent of the RT services from RO participants based furnished permitting us to identify RO Medicare-approved amount for services) on numerator and denominator Model participants while still using and sequestration would remain in specifications for each measure (for CBSA as a geographic unit of selection. effect. RO participants would have the example, not just Medicare beneficiaries In addition, we propose to exclude ability to earn back a portion of the or beneficiaries receiving care for RT certain providers and suppliers from quality and patient experience episodes under the RO Model). withholds based on their reporting of participation under the model as (6) Data Sharing Process described in section III.C.3.c. of this clinical data, their reporting and proposed rule. performance on quality measures, and We propose to collect quality, We propose to include beneficiaries as of PY3 performance on the clinical, and administrative data for the that meet certain criteria under the RO beneficiary-reported Consumer RO Model. We intend to share certain Assessment of Healthcare Providers and data with participants to the extent Model. For example, the proposed ® criteria would require that a beneficiary Systems (CAHPS ) Cancer Care permitted by the Health Insurance have a diagnosis of at least one of the Radiation Therapy Survey. Portability and Accountability Act of cancer types included in the RO Model 1996 (HIPAA) Privacy Rule and other (5) Quality Measures and Reporting applicable law. We propose to establish and that the beneficiary receive RT Requirements services from a participating provider or data privacy compliance standards for We propose to adopt four quality supplier in one of the selected CBSAs. RO participants. We propose to measures and collect the CAHPS® Beneficiaries who meet these criteria establish requirements around the Cancer Care Radiation Therapy Survey would be included in the RO Model’s public release of patient de-identified for the RO Model. Three of the four episodes of care. information by RO participants. We measures that we are proposing are propose to offer RO participants the (3) Overlap With Other CMS Programs National Quality Forum (NQF)-endorsed opportunity to request a claims data file and Models process measures that are clinically that contains patient-identifiable data We expect that there could be appropriate for RT and are approved for on the RO participant’s patient the Merit-based Incentive Payment population for clinical treatment, care situations where a Medicare beneficiary 23 included in an episode under the RO System (MIPS). We selected all management and coordination, and Model is also assigned, aligned, or proposed measures based on clinical quality improvement activities. Also, we attributed to another Innovation Center appropriateness for RT services propose to permit the data to be reused model or CMS program. Overlap could spanning a 90-day episode period. by RO participants for provider also occur among providers and incentive design and implementation, 2 NQF endorsement summaries: http:// and we believe it may be of use in RO suppliers at the individual or www.qualityforum.org/News_And_Resources/ Endorsement_Summaries/Endorsement_ participants’ review of our calculation 1 See https://www.census.gov/programs-surveys/ Summaries.aspx. of their participant-specific episode metro-micro/about/omb-bulletins.html. 3 See the CY 2018 QPP final rule (82 FR 53568). payment amounts and reconciliation

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payment amounts or recoupment Managing Clinicians located in selected applying to claims for dialysis and amounts, as applicable. Thus, we expect geographic areas. The proposed ETC dialysis-related services with claim- that the data offered under the RO Model would include two payment through dates beginning January 1, Model would be used by RO adjustments. The first adjustment, the 2021, and ending June 30, 2026. participants and CMS to better Home Dialysis Payment Adjustment (2) Model Scope understand model effects, establish (HDPA), would be a positive adjustment benchmarks, and monitor participant on certain home dialysis and home The proposed ETC Model would be a compliance. Again, as previously dialysis-related claims during the initial mandatory payment model focused on described, the data uses and sharing three years of the model. The second encouraging greater use of home dialysis would be allowed only to the extent adjustment, the Performance Payment and kidney transplants for ESRD permitted by the HIPAA Privacy Rule Adjustment (PPA), would be a positive Beneficiaries. The rationale for a and other applicable law. or negative adjustment on dialysis and mandatory model for ESRD facilities When using or disclosing such data, dialysis-related Medicare payments, for and Managing Clinicians within the RO participant would be required to both home dialysis and in-center selected geographic areas is that we seek make ‘‘reasonable efforts to limit’’ the dialysis, based on ESRD facilities’ and to test the effect of payment incentives information to the ‘‘minimum Managing Clinicians’ rates of kidney on availability and choice of treatment necessary’’ as defined by 45 CFR and kidney-pancreas transplants and modality among a diverse group of 164.502(b) and 164.514(d) to home dialysis among attributed providers and suppliers. We would accomplish the intended purpose of the beneficiaries during the applicable MY. randomly select Hospital Referral use, disclosure, or request. The RO We propose to implement the payment Regions (HRRs) for inclusion in the participant would be required to further adjustments under the ETC Model Model, and also include all HRRs with limit its disclosure of such information beginning January 1, 2020, and ending at least 20 percent of zip codes located to what is permitted by applicable law, June 30, 2026. in Maryland in addition to those including the regulations promulgated selected through randomization. under the HIPAA and the Health a. Summary of Major Provisions Managing Clinicians and ESRD facilities Information Technology for Economic (1) Proposed ETC Model Overview located in these selected geographic and Clinical Health (HITECH) laws at 45 areas would be required to participate in Beneficiaries with ESRD generally the ETC Model and would be assessed CFR part 160 and subparts A and E of require some form of renal replacement part 164. Further discussion of data on their rates of kidney and kidney- therapy, the most common being pancreas transplant and home dialysis sharing can be found in section III.C.13 hemodialysis (HD), followed by of this proposed rule. among their attributed beneficiaries peritoneal dialysis (PD), or a kidney during each MY; CMS would then (7) Beneficiary Protections transplant. Most beneficiaries with adjust certain of their Medicare We propose to require professional ESRD receive HD treatments in an ESRD payments upwards or downwards participants and dual participants to facility; however, other renal during the corresponding performance notify RO beneficiaries of the replacement modalities—including payment adjustment period. Managing beneficiary’s inclusion in this model dialyzing at home or receiving a kidney Clinicians and ESRD facilities located in through a standardized written notice to transplant—may be better options than the selected geographic areas would also each RO beneficiary during the in-center dialysis for more beneficiaries receive a positive adjustment on their treatment planning session. We intend than currently use them. We propose home dialysis claims for the first three to provide a notification template, the ETC Model to test the effectiveness years of the ETC Model. which RO participants may personalize of adjusting certain Medicare payments (3) Home Dialysis Payment Adjustment with contact information and logos, but to ESRD facilities and Managing (HDPA) must otherwise not be changed. Further Clinicians—clinicians who bill the explanation of the beneficiary Monthly Capitation Payment (MCP) for We propose that CMS would make notification can be found in section managing ESRD Beneficiaries—to upward adjustments to the certain III.C.15. of this proposed rule. encourage greater utilization of home payments to participating ESRD dialysis and kidney transplantation, facilities under the ESRD Prospective (8) Program Policy Waivers support beneficiary modality choice, Payment System (PPS) on home dialysis We believe it would be necessary to reduce Medicare expenditures, and claims, and would make upward waive certain requirements of title XVIII preserve or enhance the quality of care. adjustments to the MCP paid to of the Act solely for purposes of We believe ESRD facilities and participating Managing Clinicians on carrying out the testing of the RO Model Managing Clinicians are the key home dialysis claims. The HDPA would under section 1115A(b) of the Act. We providers and suppliers managing the apply to claims with claims through propose to issue these waivers using our dialysis care and treatment modality dates beginning on January 1, 2020, and waiver authority under section options for ESRD Beneficiaries and have ending on December 31, 2022. 1115A(d)(1) of the Act. Each of the a vital role to play in beneficiary (4) Home Dialysis and Transplant waivers is discussed in detail in section modality selection and assisting Performance Assessment and III.C.10. of this proposed rule, and beneficiaries through the transplant Performance Payment Adjustment (PPA) proposed to be codified in our process. We propose to adjust payments regulations at § 512.280. for home dialysis claims with claim We propose to assess ETC through dates from January 1, 2020, Participants’ rates of home dialysis and 3. Model Overview—Proposed ESRD through December 31, 2022 through the kidney and kidney-pancreas transplants Treatment Choices (ETC) Model HDPA, and to assess the rates of home during a MY, which would include 12 The proposed ETC Model would be a dialysis and kidney transplant among months of performance data. Each MY mandatory payment model, focused on beneficiaries attributed to ETC would overlap with the previous MY, if encouraging greater use of home dialysis Participants during the period beginning any, and the subsequent MY, if any, for and kidney transplants for ESRD January 1, 2020, and ending June 30, a period of 6 months. Each MY would Beneficiaries among ESRD facilities and 2025, with the PPA based on those rates have a corresponding PPA Period—a 6-

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month period, which would begin 6 services. The payment adjustments (7) Monitoring and Quality Measures months after the conclusion of the MY. made under the ETC Model would be Consistent with the monitoring CMS would adjust certain payments for counted as expenditures under the requirements proposed in the general ETC Participants during the PPA Period Medicare Shared Savings Program and provisions, we propose to closely based on the ETC Participant’s home other shared savings initiatives. monitor the implementation and dialysis rate and transplant rate during Additionally, ESRD facilities would outcomes of the ETC Model throughout the corresponding MY. We propose remain subject to the quality its duration. The purpose of this measuring rates of home dialysis and requirements in ESRD Quality Incentive monitoring would be to ensure that the transplants for ESRD facilities and Program (QIP), and Managing Clinicians ETC Model is implemented safely and Managing Clinicians using Medicare who are MIPS eligible clinicians would appropriately, the quality or experience claims data, Medicare administrative remain subject to MIPS. of care for beneficiaries is not harmed, data including enrollment data, and the and adequate patient and program (6) Medicare Payment Waivers Scientific Registry of Transplant integrity safeguards are in place. Recipients (SRTR) data. We propose to In order to make the proposed As part of the monitoring strategy, we measure home dialysis rates for ESRD payment adjustments under the ETC propose using two quality measures for facilities and Managing Clinicians in the the ETC Model: The Standardized ETC Model by calculating the percent of Model, namely the HDPA and PPA, we believe we would need to waive certain Mortality Ratio and the Standardized dialysis treatment beneficiary years Hospitalization Ratio. These measures during the MY in which attributed Medicare program rules. In particular, we would waive certain requirements of are NQF-endorsed, and are currently beneficiaries received dialysis at home. calculated at the ESRD facility level for We propose to measure transplant rates the Act for the ESRD PPS, ESRD QIP, and Medicare Physician Fee Schedule Dialysis Facility Reports and the ESRD for ESRD facilities and Managing QIP, respectively, and so would require Clinicians based on the number of only to the extent necessary to make these payment adjustments under this no additional reporting by ETC attributed beneficiaries who received a Participants. kidney or kidney-pancreas transplant proposed payment model for ETC during the MY out of all attributed Participants selected in accordance with (8) Beneficiary Protections dialysis treatment beneficiary years (and CMS’s proposed selection methodology. As proposed, the ETC Model would attributed beneficiary years for pre- In addition, we propose that the not allow beneficiaries to opt out of the emptive transplant beneficiaries for payment adjustments made under the payment methodology; however, the Managing Clinicians) during the MY. ETC Model, if finalized, would not model would not restrict a beneficiary’s For both Managing Clinicians and ESRD change beneficiary cost-sharing from the freedom to choose an ESRD facility or facilities, we propose to calculate the regular Medicare program cost-sharing Managing Clinician, or any other rates of home dialysis and kidney and for the related Part B services that were provider or supplier, and ETC kidney-pancreas transplants among paid for beneficiaries who receive Participants would be subject to the attributed ESRD Beneficiaries. For services from ETC Participants. general provisions protecting Managing Clinicians, we propose to also We also believe it would be necessary beneficiary freedom of choice and include attributed beneficiaries who to waive certain Medicare payment access to medically necessary services. receive preemptive transplants— requirements of 1861(ggg) of the Act and We also would require that ETC transplants that occur before the implementing regulations at 42 CFR Participants notify beneficiaries of the beneficiary begins dialysis—in the 410.48, regarding the use of the Kidney ETC Participant’s participation in the calculation of the transplant rate. We Disease Education (KDE) benefit, solely ETC Model by prominently displaying propose that the ETC Model would for the purposes of testing the ETC informational materials in ESRD make upward and downward Model. The purpose of such waivers facilities and Managing Clinician offices adjustments to certain payments to would be to give ETC Participants or facilities where beneficiaries receive participating ESRD facilities under the additional access to the tools necessary care. Additionally, ETC Participants ESRD PPS and to the MCP paid to to ensure beneficiaries select their would be subject to the general participating Managing Clinicians based preferred kidney replacement modality. provisions regarding descriptive model upon the ETC Participant’s rates of As education is a key component of materials and activities. home dialysis and transplants. The assisting beneficiaries with making such II. General Provisions magnitude of the positive and negative selections, we propose to waive select PPAs for ETC Participants would requirements regarding the provision of A. Introduction increase over the course of the Model. the KDE benefit, including waiving the Section 1115A of the Act authorizes These PPAs would begin July 1, 2021, requirement that certain health care and end June 30, 2026. the Innovation Center to test innovative provider types must furnish the KDE payment and service delivery models (5) Overlaps With Other Innovation service to allow additional staff to expected to reduce Medicare, Medicaid, Center Models and CMS Programs furnish the service, waiving the and CHIP expenditures while preserving The ETC Model would overlap with requirement that the KDE service be or enhancing the quality of care several other CMS programs and furnished to beneficiaries with Stage IV furnished to such programs’ models, including initiatives CKD to allow ETC Participants to beneficiaries. The Innovation Center has specifically focusing on dialysis care. furnish these services to beneficiaries in designed and tested numerous models We believe the ETC Model would be later stages of kidney disease, and governed by participation agreements, compatible with other dialysis-focused waiving certain restrictions on the KDE cooperative agreements, model-specific CMS programs and models. However, curriculum to allow the content benefit addenda to existing contracts with CMS, we would work to resolve any potential to be tailored to each beneficiary’s and regulations. While each of these overlaps between the ETC Model and needs. models have a specific payment other Innovation Center models or CMS We propose to issue these waivers methodology, quality metrics, and programs that could result in repetitive using our waiver authority under certain other applicable policies, they services or duplicative payment of section 1115A(d)(1) of the Act. also have general provisions that are

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very similar, including provisions on impacting the care of model 1. Beneficiary Freedom of Choice monitoring and evaluation; compliance beneficiaries related to the test of the A beneficiary’s ability to choose his or with model requirements and applicable Innovation Center model performed her provider or supplier is an important laws; and beneficiary protections. We under the terms of proposed part 512. principle of Medicare FFS and is believe it would promote efficiency to While not used in the general provisions codified in section 1802(a) of the Act. propose and seek comment on certain described in this section II of the To help ensure that this protection is general provisions in each of these areas proposed rule, as this term is used for not undermined by the testing of the that would apply to both the RO Model purposes of both the RO Model and the two proposed Innovation Center and the ETC Model in this section II of ETC Model, we propose to define ‘‘U.S. models, we are proposing to codify at the proposed rule. This would avoid the Territories’’ to mean American Samoa, § 512.120(a)(1) a requirement that model need to restate the same provisions the Federated States of Micronesia, participants and their downstream separately for the two models in this Guam, the Marshall Islands, the participants not restrict a beneficiary’s proposed rule. We propose to codify Commonwealth of the Northern Mariana ability to choose his or her providers or these general provisions in a new Islands, Palau, Puerto Rico, U.S. Minor suppliers. The proposed policy would subpart of the Code of Federal Outlying Islands, and the U.S. Virgin apply with respect to all Medicare FFS Regulations (42 CFR part 512, subpart Islands. beneficiaries, not just model A). We invite public comment on the beneficiaries, because we believe it is B. Effective Date and Scope proposed general provisions discussed important to ensure that the proposed In § 512.100(a), we propose that the in this section II of the proposed rule. Innovation Center model tests do not interfere with the general guarantees proposed general provisions in this C. Definitions section II of the proposed rule would and protections for all Medicare FFS apply only to the RO Model and the We propose at § 512.110 to define beneficiaries. ETC Model, each of which we are certain terms relevant to the general Also, we propose to codify at proposing to refer to as an ‘‘Innovation provisions proposed in this section II. of § 512.120(a)(2) that the model Center model’’ for purposes of this the proposed rule. We describe these participant and its downstream section II. of the proposed rule. These proposed definitions in context participants must not commit any act or proposed general provisions would not, throughout this section II. of the omission, nor adopt any policy that except as specifically noted in proposed proposed rule. inhibits beneficiaries from exercising new part 512, affect the applicability of their freedom to choose to receive care other provisions affecting providers and D. Beneficiary Protections from any Medicare-participating provider or supplier, or from any health suppliers under Medicare FFS, As we design and test new models at including the applicability of provisions care provider who has opted out of the Innovation Center, we believe it is Medicare. We believe this requirement regarding payment, coverage, and necessary to have certain protections in program integrity (such as those in parts is necessary to ensure Innovation Center place to ensure that beneficiaries retain models do not prevent beneficiaries 413, 414, 419, 420, and 489 of chapter their existing rights and are not harmed IV of 42 CFR and those in parts 1001– from the general rights and guarantees by the participation of their health care provided under Medicare FFS. 1003 of chapter V of 42 CFR). providers in Innovation Center models. In § 512.100(b), we propose that the However, because we believe that it is Therefore, we believe it is necessary to proposed general provisions in this important for model participants to have propose certain provisions regarding section II of the proposed rule would be the opportunity to explain the benefits beneficiary choice, the availability of applicable to model participants in both of care provided by them to model services, and descriptive model the RO Model (with one exception, beneficiaries, we also are proposing that materials and activities. described in this document) and the the model participant and its ETC Model. We are proposing to define For purposes of the general downstream participants would be the term ‘‘model participant’’ to mean provisions, we are proposing to define permitted to communicate to model an individual or entity that is identified the term ‘‘beneficiary’’ to mean an beneficiaries the benefits of receiving as a participant in an Innovation Center individual who is enrolled in Medicare care with the model participant, if model under the terms of proposed part FFS. This definition aligns with the otherwise consistent with the 512; the term ‘‘model participant’’ as proposed scope of the RO Model and requirements of proposed part 512 and defined in this section II of the proposed the ETC Model, in which we propose to applicable law. rule includes, unless otherwise include only Medicare FFS We propose at § 512.110 to define the specified, the terms ‘‘RO Model beneficiaries. We also are proposing to terms ‘‘provider’’ and ‘‘supplier,’’ as participant’’ or ‘‘ETC Participant’’ as define the term ‘‘model beneficiary’’ to used in proposed part 512, in a manner those terms are defined in proposed mean a beneficiary attributed to a model consistent with how these terms are subparts B and C of proposed part 512. participant or otherwise included in an used in Medicare FFS generally. We propose to define ‘‘downstream Innovation Center model under the Specifically, we would define the term participant’’ to mean an individual or terms of this proposed part; the term ‘‘provider’’ to mean a ‘‘provider of entity that has entered into a written ‘‘model beneficiary’’ as defined in this services’’ as defined under section arrangement with a model participant section would include, unless otherwise 1861(u) of the Act and codified in the pursuant to which the downstream specified, the term ‘‘RO Beneficiary’’ definition of ‘‘provider’’ at 42 CFR participant engages in one or more and beneficiaries attributed to ETC 400.202. We similarly propose to define Innovation Center model activities. A participants under § 512.360. We the term ‘‘supplier’’ to mean a downstream participant may include, believe it is necessary to propose this ‘‘supplier’’ as defined in section 1861(d) but would not be limited to, an definition of model beneficiary so as to of the Act and codified at 42 CFR individual practitioner, as defined for differentiate between Medicare FFS 400.202. We believe it is necessary to purposes of the RO Model. We propose beneficiaries generally and those define ‘‘provider’’ and ‘‘supplier’’ in this to define ‘‘Innovation Center model specifically included in an Innovation way as a means of noting to the general activities’’ to mean any activities Center model. public that we are using the generally

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applicable Medicare definitions of these participant would be prohibited from notify, or contact beneficiaries regarding terms for purposes of proposed part 512. taking action to avoid treating the Innovation Center model. We are beneficiaries with chronic conditions further proposing that the following 2. Availability of Services such as obesity or diabetes, or who are communications would not be Models tested under the authority of entitled to Medicaid because of descriptive model materials and section 1115A of the Act are designed disability. We believe it is necessary to activities: Communications that do not to test potential improvements to the specify prohibitions on avoiding directly or indirectly reference the delivery of and payment for health care treating at-risk beneficiaries, including Innovation Center model (for example, to reduce Medicare, Medicaid, and CHIP those with obesity or diabetes, or who information about care coordination expenditures while preserving or are eligible for Medicaid because of generally); information on specific enhancing the quality of care for the disability, to prevent potential lemon medical conditions; referrals for health beneficiaries of these programs. As dropping of beneficiaries. Further, we care items and services; and any other such, an important aspect of testing believe this proposal prohibiting lemon materials that are excepted from the Innovation Center models is that dropping is a necessary precaution to definition of ‘‘marketing’’ as that term is beneficiaries continue to access and counter any incentives created by the defined at 45 CFR 164.501. The receive needed care. Therefore, we are proposed Innovation Center models for potential for model participants to proposing in § 512.120(b)(1) that model model participants to avoid treating receive certain payments under the two participants and downstream potentially high-cost beneficiaries who proposed Innovation Center models may participants would be required to are most in need of quality care. This be an incentive for model participants continue to make medically necessary prohibition has been incorporated into and their downstream participants to covered services available to the governing documentation of many engage in marketing behavior that may beneficiaries to the extent required by current models being tested by the confuse or mislead beneficiaries about law. Consistent with the limitation on Innovation Center for this same reason. the Innovation Center model or their Medicare coverage under section Also, we are proposing in Medicare rights. Therefore, we believe it 1862(a)(1)(A) of the Act, we propose to § 512.120(b)(3) an additional provision is necessary to ensure that those define ‘‘medically necessary’’ to mean that would prohibit model participants materials and activities that are used to reasonable and necessary for the from taking any action to selectively educate, notify, or contact beneficiaries diagnosis or treatment of an illness or target or engage beneficiaries who are regarding the Innovation Center model injury, or to improve the functioning of relatively healthy or otherwise expected are not materially inaccurate or a malformed body member. Also, we to improve the model participant’s or misleading because these materials propose to define ‘‘covered services’’ to downstream participant’s financial or might be the only information that a mean the scope of health care benefits quality performance, a practice model beneficiary receives regarding the described in sections 1812 and 1832 of commonly referred to as ‘‘cherry- beneficiary’s inclusion in the model. the Act for which payment is available picking.’’ For example, a model Additionally, we understand that not all under Part A or Part B of Title XVIII of participant or downstream participant communications between the model the Act, which aligns with Medicare would be prohibited from targeting only participant or downstream participants coverage standards and the definition of healthy, well educated, or wealthy and the model beneficiaries would ‘‘covered services’’ used in other models beneficiaries for voluntary alignment, address the model beneficiaries’ care tested by the Innovation Center. Also, the receipt of permitted beneficiary under the model. As such, we would we propose that model beneficiaries and incentives or other interventions, or the their assignees, as defined in 42 CFR note that this proposed prohibition in reporting of quality measures. Further, no way restricts the ability of a model 405.902, would retain their rights to we are seeking comments on whether appeal Medicare claims in accordance participant or its downstream prohibiting cherry-picking will prevent participants to engage in activism or with 42 CFR part 405, subpart I. We model participants from artificially believe that model beneficiaries and otherwise alert model beneficiaries to inflating their financial or quality the drawbacks of mandatory models in their assignees should not lose the right performance results. to appeal claims for Medicare items and which they would otherwise decline to services furnished to them solely 3. Descriptive Model Materials and participate, provided that such because the beneficiary’s provider or Activities statements are not materially inaccurate supplier is participating in an In order to protect beneficiaries from or misleading. Because regulating Innovation Center model. potentially being misled about information or communication not Also, we are proposing in Innovation Center models, we are related to the model does not advance § 512.120(b)(2) to prohibit model proposing at § 512.120(c)(1) to prohibit CMS’s interest in ensuring model participants and downstream model participants and their beneficiaries are not misled about their participants from taking any action to downstream participants, from using or inclusion in an Innovation Center model avoid treating beneficiaries based on distributing descriptive model materials or their Medicare rights generally, we their income levels or based on factors and activities that are materially have proposed to define the term that would render a beneficiary an ‘‘at- inaccurate or misleading. For purposes ‘‘descriptive model materials and risk beneficiary’’ as that term is defined of proposed part 512, we propose to activities’’ such that these materials are for purposes of the Medicare Shared define the term ‘‘descriptive model not subject to the requirements of Savings Program at 42 CFR 425.20, a materials and activities’’ to mean proposed § 512.120(c)(1). practice commonly referred to as general audience materials such as Also, we propose in § 512.120(c)(4) to ‘‘lemon dropping.’’ For example, 42 CFR brochures, advertisements, outreach reserve the right to review, or have our 425.20 defines an ‘‘at-risk beneficiary’’ events, letters to beneficiaries, web designee review, descriptive model to include, without limitation, a pages, mailings, social media, or other materials and activities to determine beneficiary who has one or more materials or activities distributed or whether the content is materially chronic conditions or who is entitled to conducted by or on behalf of the model inaccurate or misleading; this review Medicaid because of disability. As such, participant or its downstream would not be a preclearance by CMS, a model participant or downstream participants when used to educate, but would take place at a time and in

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a manner specified by CMS once the group of model participants and make medically necessary covered materials and activities are in use by the includes data regarding potential services available to beneficiaries to the model participant. We believe it would unintended or undesirable effects, such extent required by law. Similarly, in be necessary for CMS to have this ability as cost-shifting. The Secretary must take order to expand a phase 1 model tested to review descriptive model materials the evaluation into account if making by the Innovation Center, among other and activities in order to protect model any determinations regarding the things, the Secretary must first beneficiaries from receiving misleading expansion of a model under section determine that such expansion would or inaccurate materials regarding the 1115A(c) of the Act. not deny or limit the coverage or Innovation Center model. Further, to In addition to model evaluations, the provision of benefits under the facilitate our ability to conduct this Innovation Center regularly monitors applicable title for applicable review and to monitor Innovation model participants for compliance with individuals. Thus, there is a particular Center models generally, in proposed model requirements. For the reasons need for CMS to be able to audit, § 512.120(c)(3) we are proposing to described in section II.H of this inspect, investigate, and evaluate require model participants and proposed rule, these compliance records and materials related to downstream participants, to retain monitoring activities are an important participation in Innovation Center copies of all written and electronic and necessary part of the model test. models to allow us to ensure that model descriptive model materials and Therefore, we are proposing to codify participants are in no way denying or activities and to retain appropriate at § 512.130, that model participants limiting the coverage or provision of records for all other descriptive model and their downstream participants must benefits for beneficiaries as part of their materials and activities in a manner comply with the requirements of 42 CFR participation in the Innovation Center consistent with § 512.135(c) (record 403.1110(b) (regarding the obligation of model. We propose to define ‘‘model- retention). entities participating in the testing of a specific payment’’ to mean a payment Also, we are proposing in model under section 1115A of the Act made by CMS only to model § 512.120(c)(2) to require model to report information necessary to participants, or a payment adjustment participants and downstream monitor and evaluate the model), and made only to payments made to model participants to include the following must otherwise cooperate with CMS’ participants, under the terms of the disclaimer on all descriptive model model evaluation and monitoring Innovation Center model that is not materials and activities: ‘‘The activities as may be necessary to enable applicable to any other providers or statements contained in this document CMS to evaluate the Innovation Center suppliers; the term ‘‘model-specific are solely those of the authors and do model in accordance with section payment’’ would include, unless not necessarily reflect the views or 1115A(b)(4) of the Act. This otherwise specified, the terms ‘‘home policies of the Centers for Medicare & participation in the evaluation may dialysis payment adjustment (HDPA),’’ include, but is not limited to, Medicaid Services (CMS). The authors ‘‘performance payment adjustment responding to surveys and participating assume responsibility for the accuracy (PPA),’’ ‘‘participant-specific in focus groups. Additional details on and completeness of the information professional episode payment,’’ or the specific research questions that we contained in this document.’’ We are ‘‘participant-specific technical episode propose that the Innovation Center proposing to require the use of this payment.’’ We believe it is necessary to model evaluation will consider for the disclaimer so that the public, and propose this definition in order to Radiation Oncology Model and ESRD beneficiaries in particular, are not distinguish payments and payment misled into believing that model Treatment Choices Model can be found adjustments applicable to model participants or their downstream in sections III.C.16. and IV.C.11. of this participants as part of their participation participants are speaking on behalf of proposed rule, respectively. Further, we in an Innovation Center model, from the agency. We seek comment on propose to conduct monitoring activities payments and payment adjustments whether we should propose a different according to proposed § 512.150, applicable to model participants as well disclaimer that alerts beneficiaries that described later in this proposed rule, as other providers and suppliers, as we prohibit misleading information and including producing such data as may certain provisions of proposed part 512 give them contact information where a be required by CMS to evaluate or would apply only to the former category beneficiary could reach out to us if they monitor the Innovation Center model, of payments and payment adjustments. suspect the information they have which may include protected health received regarding an Innovation Center information as defined in 45 CFR We note that there are audit and model is inaccurate. 160.103 and other individually record retention requirements under the identifiable data. Medicare Shared Savings Program (42 E. Cooperation With Model Evaluation CFR 425.314) and in current models and Monitoring F. Audits and Record Retention being tested under section 1115A (such Section 1115A(b)(4) of the Act By virtue of their participation in an as under 42 CFR 510.110 for the requires the Secretary to evaluate each Innovation Center model, model Innovation Center’s Comprehensive model tested under the authority of participants and their downstream Care for Joint Replacement Model). section 1115A and to publicly report the participants may receive model-specific Building off those existing evaluation results in a timely manner. payments, access to payment rule requirements, we propose in The evaluation must include an analysis waivers, or some other model-specific § 512.135(a), that the Federal of the quality of care furnished under flexibility. Therefore, we believe that Government, including, but not limited the model and the changes in program CMS’s ability to audit, inspect, to, CMS, HHS, and the Comptroller spending that occurred due to the investigate, and evaluate records and General, or their designees, would have model. Models tested by the Innovation other materials related to participation a right to audit, inspect, investigate, and Center are rigorously evaluated. For in Innovation Center models is evaluate any documents and other example, when evaluating models tested necessary and appropriate. In addition, evidence regarding implementation of under section 1115A, we require the we are proposing in § 512.110 to require an Innovation Center model. production of information that is model participants and their Additionally, in order to align with the representative of a wide and diverse downstream participants to continue to policy of current models being tested by

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the Innovation Center, we are proposing that the records must be maintained for participants and their downstream in § 512.135(b) and (c) that the model such period of time determined by CMS. participants to label data they believe is participant and its downstream We also propose that, if CMS notifies proprietary that they believe should be participants must: the model participant of a special need protected from disclosure under the • Maintain and give the Federal to retain records or there has been a Trade Secrets Act. We would note that Government, including, but not limited termination, dispute, or allegation of this approach is already in use in other to, CMS, HHS, and the Comptroller fraud or similar fault against the model models currently being tested by the General, or their designees, access to all participant or its downstream Innovation Center, including the Next documents (including books, contracts, participants, the model participant must Generation Accountable Care and records) and other evidence notify its downstream participants of Organization Model. Any such sufficient to enable the audit, the need to retain records for the assertions would be subject to review evaluation, inspection, or investigation additional period specified by CMS. and confirmation prior to CMS’s acting of the Innovation Center model, This provision will ensure that that the upon such assertion. including, without limitation, government has access to the records. We further propose to protect such documents and other evidence To avoid any confusion or disputes information from disclosure to the full regarding all of the following: regarding the timelines outlined in this extent permitted under applicable laws, ++ Compliance by the model section II.G of the proposed rule, we including the Freedom of Information participant and its downstream propose to define the term ‘‘days’’ to Act. Specifically, in proposed participants with the terms of the mean calendar days. § 512.140(b), we propose to not release Innovation Center model, including We invite public comment on these data that has been confirmed by CMS to proposed new subpart A of proposed proposed provisions regarding audits be proprietary trade secret information part 512. and record retention. and technology of the model participant ++ The accuracy of model-specific Historically, the Innovation Center or its downstream participants without payments made under the Innovation has required participants in section the express written consent of the model Center model. 1115A models to retain records for at participant or its downstream ++ The model participant’s payment least 10 years, which is consistent with participant, unless such release is of amounts owed to CMS under the the outer limit of the statute of required by law. limitations for the Federal False Claims Innovation Center model. H. Monitoring and Compliance ++ Quality measure information and Act and is consistent with the Shared the quality of services performed under Savings Program’s policy outlined at 42 Given that model participants may the terms of the Innovation Center CFR 425.314(b)(2). For this reason, we receive model-specific payments, access model, including proposed new subpart also solicit public comments on whether to payment rule waivers, or some other A of proposed part 512. we should require model participants model-specific flexibility while ++ Utilization of items and services and downstream participants to participating in an Innovation Center furnished under the Innovation Center maintain records for longer than 6 years. model, we believe that enhanced model. compliance review and monitoring of G. Rights in Data and Intellectual model participants is necessary and ++ The ability of the model Property participant to bear the risk of potential appropriate to ensure the integrity of the losses and to repay any losses to CMS, To enable CMS to evaluate the Innovation Center model. In addition, as as applicable. Innovation Center models as required by part of the Innovation Center’s ++ Patient safety. section 1115A(b)(4) of the Act and to assessment of the impact of new ++ Any other program integrity monitor the Innovation Center models Innovation Center models, we have a issues. pursuant to proposed § 512.150, special interest in ensuring that model • Maintain the documents and other described later in this rule, we are tests do not interfere with ensuring the evidence for a period of 6 years from the proposing to allow CMS to use any data integrity of the Medicare program. Our last payment determination for the obtained in accordance with proposed interests include ensuring the integrity model participant under the Innovation § 512.130 and proposed § 512.135 to and sustainability of the Innovation Center model or from the date of evaluate and monitor the proposed Center model and the underlying completion of any audit, evaluation, Innovation Center models. We further Medicare program, from both a financial inspection, or investigation, whichever propose that, consistent with section and policy perspective, as well as is later, unless— 1115A(b)(4)(B) of the Act, that CMS protecting the rights and interests of ++ CMS determines there is a special would be allowed to disseminate Medicare beneficiaries. For these need to retain a particular record or quantitative and qualitative results and reasons, as a part of the models group of records for a longer period and successful care management techniques, currently being tested by the Innovation notifies the model participant at least 30 including factors associated with Center, CMS or its designee monitors days before the normal disposition date; performance, to other providers and model participants to assess compliance or suppliers and to the public. We propose with model terms and with other ++ There has been a termination, that the data to be disseminated would applicable program laws and policies. dispute, or allegation of fraud or similar include, but would not be limited to, We believe our monitoring efforts help fault against the model participant in patient de-identified results of patient ensure that model participants are which case the records must be experience of care and quality of life furnishing medically necessary covered maintained for an additional six (6) surveys, as well as patient de-identified services and are not falsifying data, years from the date of any resulting final measure results calculated based upon increasing program costs, or taking other resolution of the termination, dispute, claims, medical records, and other data actions that compromise the integrity of or allegation of fraud or similar fault. sources. the model or are not in the best interests If CMS notifies the model participant In order to protect the intellectual of the model, the Medicare program, or of a special need to retain a record or property rights of model participants Medicare beneficiaries. group of records at least 30 days before and downstream participants, we In proposed § 512.150(b), we propose the normal disposition date, we propose propose in § 512.140(b) to require model to continue this standard practice of

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conducting compliance monitoring § 512.130, described previously. Such beneficiaries in an attempt to change activities to ensure compliance by the site visits would be conducted to model results or their model-specific model participant and each of its facilitate the model evaluation payments, including discrimination in downstream participants with the terms performed pursuant to section the provision of services to at-risk of the Innovation Center model, 1115A(b)(4) of the Act and to monitor beneficiaries (for example, due to including the requirements of proposed compliance with the Innovation Center eligibility for Medicaid based on subpart A of proposed part 512, model terms (including proposed disability). including to understand model subpart A of proposed part 512). Model participants that are enrolled participants’ use of model-specific In order to operationalize this in Medicare will remain subject to all payments and to promote the safety of proposal, we further propose in existing requirements and conditions for beneficiaries and the integrity of the § 512.150(c)(2) that CMS or its designee Medicare participation as set out in Innovation Center model. Such would provide the model participant or Federal statutes and regulations and monitoring activities would include, but its downstream participant with no less provider and supplier agreements, not be limited to: (1) Documentation than 15 days advance notice of a site unless waived under the authority of requests sent to the model participant visit, to the extent practicable. section 1115A(d)(1) of the Act solely for and its downstream participants, Furthermore, we propose that, to the purposes of testing the Innovation including surveys and questionnaires; extent practicable, CMS would attempt Center model. Therefore, in (2) audits of claims data, quality to accommodate a request that a site § 512.150(a), we propose to require that measures, medical records, and other visit be conducted on a particular date, model participants and each of their data from the model participant and its but that the model participant or downstream participants must comply downstream participants; (3) interviews downstream participant would be with all applicable laws and regulations. with members of the staff and prohibited from requesting a date that We note that a law or regulation is not leadership of the model participant and was more than 60 days after the date of ‘‘applicable’’ to the extent that its its downstream participants; (4) the initial site visit notice from CMS. requirements have been waived interviews with beneficiaries and their We believe the 60 day period would pursuant to section 1115A(d)(1) of the caregivers; (5) site visits to the model reasonably accommodate model Act solely for purposes of testing the participant and its downstream participant’s and downstream Innovation Center model in which the participants, which would be performed participants’ schedules while not model participant is participating. in a manner consistent with proposed interfering with the operation of the To protect the financial integrity of § 512.150(c), described later in this rule; Innovation Center model. Further, we each Innovation Center model, we (6) monitoring quality outcomes and propose in § 512.150(c)(3) to require the propose in § 512.150(d) that if CMS registry data; and (7) tracking patient model participant and their downstream discovers that it has made or received complaints and appeals. We believe participants to ensure that personnel an incorrect model-specific payment these specific monitoring activities, with the appropriate responsibilities under the terms of an Innovation Center which align with those currently used and knowledge pertaining to the model, CMS may make payment to, or in other models being tested by the purpose of the site visit be available demand payment from, the model Innovation Center, are necessary in during any and all site visits. We believe participant. Also, we are considering the order to ensure compliance with the this proposal is necessary to ensure an imposition of some of the deadlines set terms and conditions of the Innovation effective site visit and prevent the need forth in the Medicare reopening rules at Center model, including proposed for unnecessary follow-up site visits. 42 CFR 405.980, et seq.; specifically we subpart A of proposed part 512, and to Also, we are proposing in seek comment on whether CMS should protect beneficiaries from potential § 512.150(c)(4) that CMS or its designee be able to reopen an initial harms that may result from the activities could perform unannounced site visits determination of a model-specific of a model participant or its to the offices of model participants and payment for any reason within 1 year of downstream participants, such as their downstream participants at any the model-specific payment, and within attempts to reduce access to or the time to investigate concerns related to 4 years for good cause (as defined at 42 provision of medically necessary the health or safety of beneficiaries or CFR 405.986). We believe this may be covered services. other patients or other program integrity necessary to ensure we have a means We propose to codify in issues, notwithstanding these proposed and a timeline to make redeterminations § 512.150(b)(2), that when we are provisions. Further, we propose in on incorrect model-specific payments conducting compliance monitoring and § 512.150(c)(5) that nothing in proposed that we have made or received in oversight activities, CMS or our part 512 would limit CMS from conjunction with the proposed designees would be authorized to use performing other site visits as allowed Innovation Center models. any relevant data or information, or required by applicable law. We We propose to codify at § 512.150(e) including without limitation Medicare believe that, regardless of the model that nothing contained in the terms of claims submitted for items or services being tested, CMS must always have the the Innovation Center model or furnished to model beneficiaries. We ability to timely investigate concerns proposed part 512 would limit or believe that it is necessary to have all related to the health or safety of restrict the authority of the HHS Office relevant information available to us beneficiaries or other patients, or of Inspector General (OIG) or any other during our compliance monitoring and program integrity issues, and to perform Federal Government authority, oversight activities, including any functions required or authorized by law. including its authority to audit, information already available to us In particular, we believe that it is evaluate, investigate, or inspect the through the Medicare program. necessary for us to monitor, and for model participant or its downstream We propose to require in model participants and their participants. This provision simply § 512.150(c)(1) that model participants downstream participants to be reflects the limits of CMS authority. and their downstream participants compliant with our monitoring efforts, We invite public comment on these cooperate in periodic site visits to ensure that they are not denying or proposed provisions regarding conducted by CMS or its designee in a limiting the coverage or provision of monitoring of the proposed models and manner consistent with proposed medically necessary covered services to compliance by model participants.

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I. Remedial Action • Notify the model participant and, if We propose at § 512.165(a) that CMS As stated earlier in this proposed rule, appropriate, require the model could terminate an Innovation Center as part of the Innovation Center’s participant to notify its downstream model for reasons including, but not monitoring and assessment of the participants of the violation; limited to, the following circumstances: • • impact of models tested under the Require the model participant to CMS determines that it no longer authority of section 1115A, we have a provide additional information to CMS has the funds to support the Innovation special interest in ensuring that these or its designees; Center model; or model tests do not interfere with the • Subject the model participant to • CMS terminates the Innovation program integrity interests of the additional monitoring, auditing, or both; Center model in accordance with Medicare program. For this reason, we • Prohibit the model participant from section 1115A(b)(3)(B) of the Act. monitor for compliance with model distributing model-specific payments; As provided by section 1115A(d)(2)(E) terms as well as other Medicare program • Require the model participant to of the Act and proposed § 512.170, rules. When we become aware of remove, immediately or by a deadline termination of the Innovation Center noncompliance with these specified by CMS, its agreement with a model in accordance with section requirements, it is necessary for CMS to downstream participant with respect to 1115A(b)(3)(B) of the Act would not be have the ability to impose certain the Innovation Center model; subject to administrative or judicial administrative remedial actions on a • In the ETC Model only, terminate review. noncompliant model participant. the ETC Participant from the ETC To ensure model participants had The terms of many models currently Model; appropriate notice in the case of the being tested by the Innovation Center • Require the model participant to termination of the Innovation Center permit CMS to impose one or more submit a corrective action plan in a form model by CMS, we also propose to administrative remedial actions to and manner and by a deadline specified codify at § 512.165(b) that we would address noncompliance by a model by CMS; provide model participants with written participant. We propose that CMS may • Discontinue the provision of data notice of the model termination, which impose any of the remedial actions set sharing and reports to the model would specify the grounds for forth in proposed § 512.160(b) if we participant; termination as well as the effective date determine that the model participant or • Recoup model-specific payments; of the termination. a downstream participant— • Reduce or eliminate a model • K. Limitations on Review Has failed to comply with any of specific payment otherwise owed to the the terms of the Innovation Center model participant, as applicable; or In proposed § 512.170, we propose to model, including proposed subpart A of • Such other action as may be codify the preclusion of administrative proposed part 512, if finalized; and judicial review under section • permitted under the terms of proposed Has failed to comply with any part 512. 1115A(d)(2) of the Act. Section applicable Medicare program We would note that because the ETC 1115A(d)(2) of the Act states that there requirement, rule, or regulation; • Model is a mandatory model, we would is no administrative or judicial review Has taken any action that threatens under section 1869 or 1878 of the Act the health or safety of a beneficiary or not expect to use the proposed provision that would allow CMS to or otherwise for any of the following: other patient; • The selection of models for testing • Has submitted false data or made terminate an ETC Participant’s or expansion under section 1115A of the false representations, warranties, or participation in the ETC Model, except Act. certifications in connection with any in circumstances in which the ETC • The selection of organizations, sites, aspect of the Innovation Center model; Participant has engaged, or is engaged • in, egregious actions. or participants to test models selected. Has undergone a change in control • (as defined in section II.L. of this We invite public comment on these The elements, parameters, scope, proposed rule) that presents a program proposed provisions regarding the and duration of such models for testing proposed grounds for remedial actions, or dissemination. integrity risk; • • Is subject to any sanctions of an remedial actions generally, and whether Determinations regarding budget accrediting organization or a Federal, additional types of remedial action neutrality under section 1115A(b)(3) of state, or local government agency; would be appropriate. the Act. • Is subject to investigation or action • The termination or modification of J. Innovation Center Model Termination the design and implementation of a by HHS (including the HHS–OIG and by CMS CMS) or the Department of Justice due model under section 1115A(b)(3)(B) of to an allegation of fraud or significant We are proposing certain provisions the Act. misconduct, including being subject to that would allow CMS to terminate an • Determinations about expansion of the filing of a complaint or filing of a Innovation Center model under certain the duration and scope of a model under criminal charge, being subject to an circumstances. Section 1115A(b)(3)(B) section 1115A(c) of the Act, including indictment, being named as a defendant of the Act requires the Innovation the determination that a model is not in a False Claims Act qui tam matter in Center to terminate or modify the design expected to meet criteria described in which the Federal Government has and implementation of a model, after paragraph (1) or (2) of such section. intervened, or similar action; or testing has begun and before completion We propose to interpret the • Has failed to demonstrate improved of the testing, unless the Secretary preclusion from administrative and performance following any remedial determines, and the Chief Actuary judicial review regarding the Innovation action imposed by CMS. certifies with respect to program Center’s selection of organizations, sites, In § 512.160(b), we propose to codify spending, that the model is expected to: or participants to test models selected to that CMS may take one or more of the improve the quality of care without preclude from administrative and following remedial actions if CMS increasing program spending; reduce judicial review our selection of a model determined that one or more of the program spending without reducing the participant, as well as our decision to grounds for remedial action described in quality of care; or improve the quality terminate a model participant, as these proposed § 512.160(a) had taken place— of care and reduce spending. determinations are part of our selection

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of participants for Innovation Center terms of each model in which the model require model participants to furnish model tests. participant is participating or has notice of bankruptcy to the local CMS In addition, we propose to interpret participated and all administrative or regional office instead of, or in addition the preclusion from administrative and judicial review proceedings relating to to, the Baltimore headquarters. judicial review regarding the elements, any payments under such models have Second, in proposed § 512.180(b), we parameters, scope, and duration of been fully and finally resolved. propose that the model participant, models for testing or dissemination to Specifically, we propose that notice of including model participants that are preclude from administrative and the bankruptcy must be sent by certified individuals, would have to provide judicial review the following CMS mail within 5 days after the bankruptcy written notice to CMS at least 60 days determinations made in connection petition has been filed and that the before any change in the model with an Innovation Center model: notice must contain a copy of the filed participant’s legal name became • The selection of quality bankruptcy petition (including its effective. The notice of legal name performance standards for the docket number) and a list of all models change would have to be in a form and Innovation Center model by CMS. tested under section 1115A of the Act in manner specified by CMS and include • The assessment by CMS of the which the model participant is a copy of the legal document effecting quality of care furnished by the model participating or has participated. To the name change, which would have to participant. minimize the burden on model be authenticated by the appropriate • The attribution of model participants, while ensuring that CMS state official. The purpose of this beneficiaries to the model participant by obtains the information necessary from proposed notice requirement is to CMS, if applicable. model participants undergoing ensure the accuracy of our records We invite public comment on the bankruptcy, we propose that the list regarding the identity of model proposed codification of these statutory need not identify a model in which the participants and the entities to whom preclusions of administrative and model participant participated if final model-specific payments should be judicial review for models, as well as payment has been made under the terms made or against whom payments should our proposed interpretations regarding of the model and all administrative or be demanded or recouped. We solicit their scope. judicial review proceedings regarding comment on the typical procedure for L. Miscellaneous Provisions on model-specific payments between the effectuating a legal entity’s name change Bankruptcy and Other Notifications model participant and CMS have been and whether 60 days’ advance notice of fully and finally resolved with respect such a change is feasible. Alternatively, Models currently being tested by the to that model. The notice to CMS must we are considering requiring notice to Innovation Center usually have a be addressed to the CMS Office of be furnished promptly (for example, defined period of performance, but final Financial Management, Mailstop C3– within 30 days) after a change in legal payment under the model may occur 01–24, 7500 Security Boulevard, name has become effective. We invite long after the end of this performance Baltimore, Maryland 21244 or to such public comment on this alternative period. In some cases, a model other address as may be specified for approach. participant may owe money to CMS. We purposes of receiving such notices on Third, in proposed § 512.180(c), we recognize that the legal entity that is the the CMS website. propose that the model participant model participant may experience By requiring the submission of the would have to provide written notice to significant organizational or financial filed bankruptcy petition, CMS would CMS at least 90 days before the effective changes during and even after the obtain information necessary to protect date of any change in control. We period of performance for an Innovation its interests, including the date on propose that the written notification Center model. To protect the integrity of which the bankruptcy petition was filed must be furnished in a form and manner the proposed Innovation Center models and the identity of the court in which specified by CMS. For purposes of this and Medicare funds, we are proposing the bankruptcy petition was filed. We notice obligation, we propose that a a number of provisions to ensure that recognize that such notices may already ‘‘change in control’’ would mean any of CMS is made aware of events that could be required by existing law, but CMS the following: (1) The acquisition by any affect a model participant’s ability to often does not receive them in a timely ‘‘person’’ (as such term is used in perform its obligations under the fashion, and they may not specifically sections 13(d) and 14(d) of the Innovation Center model, including the identify the models in which the Securities Exchange Act of 1934) of payment of any monies owed to CMS. individual or entity is participating or beneficial ownership (within the First, in proposed § 512.180(a), we has participated. The failure to receive meaning of Rule 13d–3 promulgated propose that a model participant must such notices on a timely basis can under the Securities Exchange Act of promptly notify CMS and the local U.S. prevent CMS from asserting a claim in 1934), of beneficial ownership (within Attorney Office if it files a bankruptcy the bankruptcy case. We are particularly the meaning of Rule 13d–3 promulgated petition, whether voluntary or concerned that a model participant may under the Securities Exchange Act of involuntary. Because final payment may not furnish notice of bankruptcy after it 1934), directly or indirectly, of voting not take place until after the model has completed its performance in a securities of the model participant participant ceases active participation in model, but before final payment has representing more than 50 percent of the the Innovation Center model or any been made or administrative or judicial model participant’s outstanding voting other model in which the model proceedings have been resolved. We securities or rights to acquire such participant is participating or has believe our proposal is necessary to securities; (2) the acquisition of the participated (for example, because the protect the financial integrity of the model participant by any individual or period of performance for the model proposed Innovation Center models and entity; (3) the sale, lease, exchange or ends, or the model participant is no the Medicare Trust Funds. Because other transfer (in one transaction or a longer eligible to participate in the bankruptcies filed by individuals and series of transactions) of all or model), we further propose that this entities that owe CMS money are substantially all of the assets of the requirement would apply until final generally handled by CMS regional model participant; or (4) the approval payment has been made by either CMS offices, we are considering (and solicit and completion of a plan of liquidation or such model participant under the comment on) whether we should of the model participant, or an

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agreement for the sale or liquidation of services furnished during a 90-day beneficiaries who received any radiation the model participant. The proposed episode to Medicare fee-for-service treatment delivery services within that requirement and definition of change in (FFS) beneficiaries diagnosed with 3-year period. These radiation treatment control are the same requirements and certain cancer types. The base payment delivery services included various types definition used in certain models that amounts for RT services included in the of modalities.7 Such modalities are currently being tested under section Model would be the same for hospital included external beam radiotherapy 1115A authority. We believe this outpatient departments (HOPDs) and (such as 3-dimensional conformal proposed notice requirement is freestanding radiation therapy centers. radiotherapy (3DCRT), intensity- necessary to ensure the accuracy of our The performance period for the modulated radiotherapy (IMRT), records regarding the identity of model proposed RO Model would be five stereotactic radiosurgery (SRS), participants and to ensure that we pay performance years (PYs), beginning in stereotactic body radiotherapy (SBRT), and seek payment from the correct 2020, and ending December 31, 2024, and proton beam therapy), entity. For this reason, we propose that with final data submission of clinical intraoperative radiotherapy (IORT), if CMS determined in accordance with data elements and quality measures in image-guided radiation therapy (IGRT), proposed § 512.160(a)(5) that a model 2025 to account for episodes ending in and brachytherapy. We conducted participant’s change in control would 2024. several analyses of radiation treatment present a program integrity risk, CMS We are including the following patterns using that group of could take remedial action against the proposals for the Model in this beneficiaries and their associated model participant under proposed proposed rule: (1) The scope of the Medicare Part A and Medicare Part B § 512.160(b). In addition, to ensure Model, including required participants claims. payment of amounts owed to CMS, we and episodes under the Model test; (2) Our analysis showed that from propose that CMS may require the pricing methodology under the January 1, 2015 through December 31, immediate reconciliation and payment Model and necessary Medicare program 2017, HOPDs furnished 64 percent of of all monies owed to CMS by a model policy waivers to implement such episodes nationally, while freestanding participant that is subject to a change in methodology; (3) the quality measures radiation therapy centers furnished the control. selected for the Model for purposes of remaining 36 percent of episodes. We We invite public comment on these scoring a participant’s quality intend to make this data publically proposed notification requirements. performance; (4) the process for accessible in a summary-level, de- Also, we solicit comment as to whether payment reconciliation; and, (5) data identified file titled the ‘‘RO Episode the requirement to provide notice collection and sharing. File (2015–2017),’’ on the RO Model’s regarding changes in legal name and B. Background website. Our analysis also showed that, changes in control are necessary, or are on average, freestanding radiation already covered by existing reporting 1. Overview therapy centers furnished (and billed requirements for Medicare-enrolled CMS is committed to promoting for) a higher volume of RT services providers and suppliers. higher quality of care and improving within such episodes than did HOPDs. III. Proposed Radiation Oncology outcomes for Medicare beneficiaries Based on our analysis of Medicare FFS Model while reducing costs. Accordingly, as claims data from that time period, part of that effort, we have in recent episodes of care in which RT was A. Introduction years undertaken a number of initiatives furnished at a freestanding radiation We are proposing a mandatory to improve cancer treatment, most therapy center were, on average, paid Radiation Oncology Model (RO Model), notably with our Oncology Care Model approximately $1,800 (or 11 percent) referred to in this section III. of the (OCM). We believe that a model in more by Medicare than those episodes proposed rule as ‘‘the Model,’’ that radiation oncology would further these of care where RT was furnished at a would test whether prospective episode- efforts to improve cancer care for HOPD. We are not aware of any clinical based payments for radiotherapy (RT) Medicare beneficiaries and reduce rationale that explains for these services,4 (also referred to as radiation Medicare expenditures. differences, which persisted after therapy services) would reduce RT is a common treatment for nearly controlling for diagnosis, patient case Medicare program expenditures and two thirds of all patients undergoing mix (to the extent possible using data preserve or enhance quality of care for cancer treatment 56 and is typically available in claims), geography, and beneficiaries. As radiation oncology is furnished by a radiation oncologist. We other factors. These differences also highly technical and furnished in well- analyzed Medicare FFS claims between persist even though Medicare payments defined episodes, and because patient January 1, 2015, and December 31, 2017, are lower per unit in freestanding comorbidities generally do not influence to examine several aspects (including radiation therapy centers than in treatment delivery decisions, we believe but not limited to modalities, number of HOPDs. Upon further analysis, we that radiation oncology is well-suited fractions, length of episodes, Medicare observed that freestanding radiation for testing a prospective episode payments and sites of service, as therapy centers use more IMRT, a type payment model. Under this proposed described in this section) of radiation of RT associated with higher Medicare RO Model, Medicare would pay services furnished to Medicare payments, and perform more fractions participating providers and suppliers a beneficiaries during that period. We (that is, more RT treatments) than site-neutral, episode-based payment for used HOPD and Medicare Physician Fee HOPDs. specified professional and technical RT Schedule (PFS) claims, accessed 2. Site-Neutral Payments through CMS’s Chronic Conditions Data 4 Radiotherapy (RT) services (also referred to as Warehouse (CCW), to identify all FFS Under Medicare FFS, RT services radiation therapy services) are services associated furnished in a freestanding radiation with cancer treatment that use high doses of radiation to kill cancer cells and shrink tumors, and 5 Physician Characteristics and Distribution in the therapy center are paid under the encompass treatment consultation, treatment U.5., 2010 Edition, 2004 IMV Medical Information planning, technical preparation and special services Division, 2003 SROA Benchmarking Survey. 7 Modality refers to various types of radiotherapy, (simulation), treatment delivery, and treatment 6 2012/13 Radiation Therapy Benchmark Report, which are commonly classified by the type of management. IMV Medical Information Division, Inc. (2013). radiation particles used to deliver treatment.

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Medicare PFS at the non-facility rate that site-neutral payments would offer intermediate-risk prostate cancer, including payment for the professional RT providers and RT suppliers more courses of RT lasting 4 to 6 weeks lead and technical aspects of the services. certainty regarding the pricing of RT to similar cancer control and toxicity as For RT services furnished in an services and remove incentives that longer courses of RT lasting 7 to 8 outpatient department of a hospital, the promote the provision of RT services at weeks.16 17 facility services are paid under the one site of service over another. The RO Based on this review of claims data, Hospital Outpatient Prospective Model is designed to test these we believe that the current Medicare Payment System (OPPS) and the assumptions regarding site-neutrality. FFS payment systems may incentivize professional services are paid under the selection of a treatment plan with a high 3. Aligning Payments to Quality and PFS. Differences in the underlying rate- volume of services over another Value, Rather Than Volume setting methodologies used in the OPPS medically appropriate treatment plan and PFS to establish payment for RT For some cancer types, stages, and that requires fewer services. Each time services in the HOPD and in the characteristics, a shorter course of RT a patient requires radiation, providers freestanding radiation therapy centers treatment with more radiation per can bill for RT services and an array of respectively help to explain why the fraction may be appropriate. For necessary planning services to make the payment rate for the same RT service example, several randomized controlled treatment successful.18 This structure could be different. This difference in trials have shown that shorter treatment may incentivize providers and suppliers payment rate, which is commonly schedules for low-risk breast cancer to furnish longer courses of RT because referred to as the site-of-service payment yield similar cancer control and they are paid more for furnishing more differential, may incentivize Medicare cosmetic outcomes as longer treatment services. Importantly, however, the providers and suppliers to deliver RT schedules.891011 As another example, latest clinical evidence suggests that services in one setting over another, research has shown that radiation shorter courses of RT for certain types even though the actual treatment and oncologists may split treatment for bone of cancer would be equally effective and care received by Medicare beneficiaries metastases into 5 to 10 fractions, even could improve the patient experience, for a given modality is the same in both though research indicates that one potentially reduce cost for the Medicare settings. We propose to test a site- fraction is often sufficient.12 13 14 15 In program, and lead to reductions in neutral payment in the RO Model rather addition, recent clinical trials have beneficiary cost-sharing. than implementing a payment demonstrated that, for some patients in There is also some indication that the adjustment in the OPPS or PFS clinical trials with low- and latest evidence-based guidelines are not because— incorporated into practices’ treatment • The Secretary of Health and Human 8 Whelan, T.J. et al. Long-term Results of protocols in a timely manner.19 For Services does not have the authority to Hypofractionated Radiation Therapy for Breast example, while breast cancer guidelines Cancer. N. Engl. J. Med. 2010 Feb. 11; 362(6):513– adjust payments outside of established 20. https://www.ncbi.nlm.nih.gov/pubmed/ have since 2008 recommended that payment methodologies under the 20147717. radiation oncologists use shorter courses Section 1848 governing the PFS; 9 Bentzen, S.M. et al. The UK Standardisation of of treatment for lower-risk breast cancer • The Practice Expense (PE) Breast Radiotherapy (START) Trial A of (3 weeks versus 5 weeks), an analysis Radiotherapy Hypofractionation for Treatment of component of the PFS is determined Early Breast Cancer: A Randomised Trial. Lancet found that, as of 2017, only half of based on inputs (labor, equipment, and Oncol. 2008 Apr.; 9(4):331–41. https:// commercially insured patients actually supplies) and input price estimates from www.ncbi.nlm.nih.gov/pubmed/18356109. received the shorter course of entities paid under the PFS only, which 10 Bentzen, S.M. et al. The UK Standardisation of treatment.20 Breast Radiotherapy (START) Trial B of means the PE calculation cannot Radiotherapy Hypofractionation for Treatment of 4. CMS Coding and Payment Challenges consider HOPD cost data that the RO Early Breast Cancer: A Randomised Trial. Lancet Model proposes to use as the basis for Oncol. 2008 Mar. 29; 371(9618): 1098–107. https:// We identified several coding and national base rates; www.ncbi.nlm.nih.gov/pubmed/18355913. payment challenges for RT services. (1) • Further, the PE methodology 11 Haviland, J.S. et al. The UK Standardisation of Under the PFS, payment is set for each Breast Radiotherapy (START) Trials of service using resource-based relative itself calculates a PE amount for each Radiotherapy Hypofractionation for Treatment of service relative to all of the other Early Breast Cancer: 10-Year Follow-Up Results of value units (RVUs). The RVUs have services paid under the PFS in a budget Two Randomised Controlled Trials. Lancet Oncol. three components: Clinician work 2013 Oct.; 14(11): 1086–94. https:// (Work), practice expense (PE), and neutral manner and consistent with www.ncbi.nlm.nih.gov/pubmed/24055415. estimates of appropriate division of PFS 12 Sze, W.M. et al. Palliation of Metastatic Bone 16 payments between PE, physician work, Pain: Single Fraction Versus Multifraction D. Dearnaley, I. Syndikus, H. Mossop, et al. Radiotherapy—A Systematic Review of The Conventional versus hypofractionated high-dose and malpractice resource costs; and intensity-modulated radiotherapy for prostate (2) • Both the PFS and OPPS make Randomised Trials. Cochrane Database Syst. Rev. 2004; (2):CD004721. https://www.ncbi.nlm.nih.gov/ cancer: 5-Year outcomes of the randomised, non- the same payment for a service, pubmed/15106258. inferiority, phase 3 CHHiP trial. Lancet Oncol, 17 (2016), pp. 1047–1060. http:// irrespective of the diagnosis, whereas 13 Chow, E. et al. Update on the Systematic www.sciencedirect.com/science/article/pii/ the RO Model establishes different Review of Palliative Radiotherapy Trials for Bone Metastases. Clin. Oncol. (R. Coll. Radiol.). 2012 S1470204516301024. payments by cancer type. 17 W.R. Lee, J.J. Dignam, M.B. Amin, et al. (3) • Neither payment system would Mar; 24 (2):112–24. https://www.ncbi.nlm.nih.gov/ pubmed/22130630. Randomized phase III noninferiority study allow flexibility in testing new and 14 Chow, Ronald et al. Efficacy of Multiple comparing two radiotherapy fractionation comparable approaches to value-based Fraction Conventional Radiation Therapy for schedules in patients with low-risk prostate cancer. payment outside of statutory quality Painful Uncomplicated Bone Metastases: A J Clin Oncol, 34 (2016), pp. 2325–2332. http:// ascopubs.org/doi/full/10.1200/JCO.2016.67.0448. reporting programs. Systematic Review. Radiotherapy & Oncology: March 2017 Volume 122, Issue 3, Pages 323–331. 18 These planning and technical preparation We believe a site-neutral payment http://www.thegreenjournal.com/article/S0167- services include dose planning, treatment aids, CT policy would address the site-of-service 8140(16)34483-8/abstract. simulations, and other services. payment differential that exists under 15 Lutz, Stephen et al. Palliative Radiation 19 http://www.npr.org/sections/health-shots/2017/ the OPPS and PFS by establishing a Therapy for Bone Metastases: Update of an ASTRO 10/21/558837836/many-breast-cancer-patients- receive-more-radiation-therapy-than-needed. common payment amount to pay for the Evidence-Based Guideline. Practical Radiation Oncology (2017) 7, 4–12. http:// 20 https://www.practicalradonc.org/cms/10.1016/ same services regardless of where they www.practicalradonc.org/article/S1879- j.prro.2018.01.012/attachment/775de137-63cb- are furnished. In addition, we believe 8500(16)30122-9/pdf. 4c5d-a7f9-95556340d0f6/mmc1.pdf.

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professional liability or malpractice identified these codes as potentially reporting rules for the same services, insurance expense (MP). In setting the misvalued services during CY 2012 which contribute to site-of-service PE RVUs for services, we rely heavily on under a screen called ‘‘Services with payment differentials. These differences voluntary submission of pricing Stand-Alone PE Procedure Time.’’ We in payment systems can create information for supplies and equipment, observed significant discrepancies confusion for RT providers and RT and we have limited means to validate between the 60-minute procedure time suppliers, particularly when they the accuracy of the submitted assumptions for IMRT. Public furnish services in both freestanding information. As a result, it is difficult to information suggested that the radiation therapy centers and HOPDs. establish the cost of expensive capital procedure typically took between 5 and Finally, there are coding and payment equipment, such as a linear accelerator, 30 minutes. In CY 2015, the American challenges specific to freestanding in order to determine PE RVUs for Medical Association CPT® Editorial radiation therapy centers. Through the physicians’ services that use such Panel revised the entire code set that annual PFS rulemaking process, we equipment.21 describes RT delivery. CMS proposed receive comments from stakeholders Further, we have examined RT values for these services in the CY 2016 representing freestanding radiation services and their corresponding codes proposed rule but, due to challenges in therapy centers and physicians who under our potentially misvalued codes revaluing the new code set, finalized the furnish services in freestanding initiative based on their high volume use of G-codes that we established to radiation therapy centers. In recent and increasing use of new technologies. largely mirror the previous radiation years, these stakeholder comments have Specifically, we reviewed codes for RT treatment coding structure.22 The noted the differences and complexity in services for Calendar Years (CYs) 2009, Patient Access and Medicare Protection payment rates and policies for RT 2012, 2013, and 2015 as potentially Act (PAMPA) (Pub. L. 114–115), services between the PFS and OPPS; misvalued services. In general, when a enacted on December 28, 2015, expressing particular concerns about code is identified as potentially addressed payment for certain RT differences in payment for RT services misvalued, we finalize the code as delivery and related imaging services furnished in freestanding radiation misvalued and then review the Work under the PFS, and the Bipartisan therapy centers and HOPDs despite that and PE RVU inputs for the code. As a Budget Act (BBA) of 2018 (Pub. L. 115– the fixed, capital costs associated with result of the review, the inputs can be 123) required the PFS to use the same linear accelerators that are used to adjusted either upward or downward. service inputs for these codes as existed furnish these services do not differ The criteria for identifying potentially in 2016 for CY 2017, 2018, and 2019. across settings; and raising certain misvalued codes are set forth in section (The PAMPA and BBA are discussed in perceived deficiencies in the PFS rate- 1848(c)(2)(K)(ii) of the Act. detail in this rule). setting methodology as it applies to RT Through annual rulemaking for the Despite the aforementioned services delivered in freestanding 23 PFS, we review and adjust values for challenges related to information used radiation therapy centers. It is also potentially misvalued services, and also to establish payment rates for RT important to note that even if we were establish values for new and revised services, we have systematically able to obtain better pricing information codes. We establish Work and PE RVU attempted to improve the accuracy of for inputs, due to the differing rate- inputs for new, revised, and potentially payment for these codes under the PFS. setting methodologies, PFS rates are misvalued codes based on a review of While the potentially misvalued code developed in relation to other PFS information that generally includes, but review process is essential to the PFS, office-based services, not to OPPS is not limited to, recommendations some stakeholders have expressed payment rates. As previously noted, the PAMPA received from the American Medical concern that changes in Work and PE addressed payment for certain RT Association’s RVS Update Committee RVUs have led to fluctuations in delivery and related imaging services (AMA/RUC), Health Care Professional payment rates. Occasionally, changes in under the PFS. Specifically, section 3 of Advisory Committee (HCPAC), PE RVUs for one or more CPT® codes the PAMPA directed CMS to maintain Medicare Payment Advisory occur outside of the misvalued code the 2016 code definitions, Work RVU Commission (MedPAC), and other review cycle if there are updates to the inputs, and PE RVU inputs for 2017 and public commenters; medical literature equipment and supply pricing. Any 2018 for certain RT delivery and related and comparative databases; a changes to CPT® code valuations, comparison of the work for other codes imaging services; prohibited those codes including supply and equipment pricing from being considered as potentially within the PFS; and consultation with changes, are subject to public comment other physicians and health care misvalued codes for 2017 and 2018; and and review. directed the Secretary to submit a professionals within CMS and other Although the same code sets generally Report to Congress on development of federal government agencies. We also are used for purposes of the PFS and an episodic alternative payment model consider the methodology and data used OPPS, there are differences between the (APM) for Medicare payment for to develop the recommendations codes used to describe RT services radiation therapy services furnished in submitted to us by the RUC and other under the PFS and the OPPS, and those non-facility settings. Section 51009 of public commenters, and the rationale in commercial use more broadly. We for their recommendations. the BBA of 2018 extended these continue to use some CMS-specific payment policies through 2019. In Through the annual rulemaking coding, or HCPCS codes, in billing and process previously described, we have November 2017, we submitted the payment for RT services under the PFS Report to Congress as required by reviewed and finalized payment rates while OPPS is largely based on CPT® for several RT codes over the past few section 3(b) of the PAMPA.24 In the codes. As a result of coding and other report, we discussed the current status years. The American Medical differences, these payment systems Association identified radiation utilize different payment rates and treatment coding for review because of 23 See generally, CY 2018 PFS final rule with comment period, 82 FR 52976; CY 2015 PFS final site of service anomalies. We first 22 See generally, CY 2015 PFS final rule with rule with comment period, 79 FR 67547; CY 2014 comment period, 79 FR 67547; CY 2016 PFS final PFS final rule with comment period, 78 FR 43296. 21 CY 2014 PFS final rule with comment period, rule with comment period, 80 FR 70885; CY 2016 24 https://innovation.cms.gov/resources/ 78 FR 43296, 43286–43289, 43302–43311. PFS correcting amendment, 81 FR 12024. radiationapm-pubforum.html.

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of RT services and payment, and 1. Proposed Model Performance Period services within randomly selected reviewed model design considerations We propose to test the RO Model for CBSAs would be required to participate for a potential APM for RT services. 5 PYs. We propose to define ‘‘model in the RO Model (see III.C.3.b. of this In preparing the Report to Congress, performance period’’ to mean January 1, proposed rule (Proposed RO Model the Innovation Center conducted an 2020, the date the Model begins, Participants) and III.C.3.d. of this proposed rule (Geographic Unit of environmental scan of current evidence, through December 31, 2024, the last Section)). To date, the Innovation Center as well as held a public listening session date during which episodes under the has tested one voluntary prospective followed by an opportunity for RT Model must be completed. Alternatively, we are considering episode payment model, Bundled stakeholders to submit written Payments for Care Improvement (BPCI) comments about a potential APM. A delaying implementation to April 1, 2020 to give RO participants and CMS Model 4 that attracted only 23 review of the applicable evidence cited participants, of which 78 percent in the Report to Congress demonstrated additional time to prepare. An April 2020 start date would only affect the withdrew from the initiative. As such, that episode payment models can be a we are interested in testing and tool for improving quality of care and length of PY1 which would be nine months. All other PYs would be 12 evaluating the impact of a prospective reducing expenditures. Episode payment approach for RT services in a payment models pay a fixed price based months. For all episodes to be completed by December 31, 2024, no variety of circumstances. We believe on the expected costs to deliver a new episodes may begin after October 3, that by requiring the participation of RT bundle of services for a clinically 2024. We invite public comments on the providers and RT suppliers, we would defined episode of care. We believe that proposed model performance period have access to more complete evidence radiation oncology is a promising area and potential participants’ ability to be of the impact of the Model. of health care for episode payments, in ready to implement the RO Model by A representative sample of RT part, based on the findings in the Report January 1, 2020. We also seek comments providers and RT suppliers for the to Congress. While the report discusses on delaying the start of the model proposed Model would result in a several options for an APM, in this performance period to April 1, 2020. robust data set for evaluation of this proposed rule, we propose what the prospective payment approach, and Innovation Center has determined to be 2. Proposed Definitions would stimulate the rapid development the best design for testing an episodic We propose at § 512.205 to define of new evidence-based knowledge. APM for RT services. certain terms for the RO Model. We Testing the Model in this manner would describe these proposed definitions in also allow us to learn more about C. RO Model Proposed Regulations context throughout this section III of patterns of inefficient utilization of health care services and how to In this proposed rule, we propose our this proposed rule. We invite public incentivize the improvement of quality policies for the RO Model, including comments on these proposed definitions. for RT services. This learning could model-specific definitions and the potentially inform future Medicare general framework for implementing the 3. Proposed Participants payment policy. Therefore, we are RO Model. We propose to define We propose that certain Medicare proposing a broad, representative ‘‘performance year’’ (PY) as the 12- participating HOPDs, physician group sample of RT providers and RT month period beginning on January 1 practices (PGPs), and freestanding suppliers in multiple geographic areas and ending on December 31 of each year radiation therapy centers that furnish (see Section III.C.3.d. of this proposed during the model performance period. RT services (RT providers or RT rule for a discussion regarding the We propose to codify the term suppliers) in randomly selected Core- Geographic Unit of Selection). We ‘‘performance year’’ at § 512.205 of our Based Statistical Areas (CBSAs), would determined that the best method for regulations. be required to participate in the RO obtaining the necessary diverse, In this proposed rule, we are Model either as ‘‘Professional representative group of RT providers including our proposed policies for each participants,’’ ‘‘Technical participants,’’ and RT suppliers would be random of the following: (1) The scope of the RO or ‘‘Dual participants’’ (as such terms selection. This is because a randomly Model, including the Model are defined in section III.C.3.b of this selected sample would provide analytic participants, beneficiary population, proposed rule). We propose to define results that would be more generally and RT episodes that would be included ‘‘RO participant’’ at § 512.205 as a PGP, applicable to all Medicare FFS RT in the test; (2) the pricing methodology freestanding radiation therapy center, or providers and RT suppliers and would under the Model and the Medicare HOPD that participates in the RO Model allow for a more robust evaluation of the program policy waivers necessary to pursuant to the criteria that we propose Model. implement such methodology; (3) the to establish at § 512.210. (See III.C.3.b In addition, actuarial analysis measure selection for the model, Proposed RO Model Participants.) In suggests that the difference in estimated price updates for rates in the OPPS and including performance scoring addition, we note that the proposed PFS systems from 2019 through 2023, in methodology and applying quality to definition of ‘‘model participant,’’ as which the OPPS rates are expected to payment; (4) the process for payment defined in section III.C.3.b of this rule, increase substantially more than PFS reconciliation; and (5) data collection would include a RO participant. In this rates, would result in few to no HOPDs and sharing. section, we explain our proposals regarding mandatory participation, the electing to voluntarily participate in the We propose to codify RO Model types of entities that would be required Model. Further, actuarial estimates policies at 42 CFR part 512, subpart B to participate, and the geographic areas suggested that freestanding radiation (proposed §§ 512.200 through 512.290). that would be subject to the RO Model therapy centers with historically lower In addition, as we explain in section II test. RT costs compared to the national of this proposed rule, if finalized, the average would most likely choose to general provisions proposed to be a. Proposed Required Participation participate, but those with historically codified at §§ 512.100 through 512.180 We propose that certain RT providers higher costs would be less likely to would apply to the proposed RO Model. and RT suppliers that furnish RT voluntarily participate. Requiring

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participation in the RO Model would which furnishes only the technical • Participates in or is identified as ensure sufficient proportional component of RT services. Finally, we eligible to participate in the participation of both HOPDs and propose to define ‘‘Dual participant’’ to Pennsylvania Rural Health Model. freestanding radiation therapy centers, mean a RO participant that furnishes for These exclusion criteria would apply which is necessary to obtain a diverse, both the professional component and during the entire model performance representative sample of RT providers technical component of an episode for period. If a RO participant undergoes and RT suppliers and to help support a RT services through a freestanding changes such that one or more of the statistically robust test of the radiation therapy center, identified by a proposed exclusion criteria becomes prospective episode payments made single TIN. We propose to codify the applicable to the RO participant during under the RO Model. terms ‘‘Professional participant,’’ the model performance period, then that For these reasons, we believe that a ‘‘Technical participant,’’ ‘‘Dual RO participant would be excluded from mandatory model design would be the participant’’ and ‘‘individual the RO Model (that is, it would no best way to improve our ability to detect practitioner’’ at § 512.205. longer be a RO participant subject to and observe the impact of the As previously explained, a RO inclusion criteria). For example, if a RO prospective episode payments made participant would furnish at least one participant moves its only service 25 under the RO Model. We therefore component of an episode, which we are location from a randomly selected propose that participation in the RO proposing to have two components: A CBSA in Virginia to Maryland, it would Model would be mandatory for all RT professional component and a technical be excluded from the RO Model from providers and RT suppliers furnishing component. We propose to define the the date of its location change. RT services within the randomly term ‘‘professional component (PC)’’ to Conversely, if a PGP, freestanding selected CBSAs. mean the included RT services that may radiation therapy center, or HOPD We invite public comments on our only be furnished by a physician. We satisfies the exclusion criteria when the proposal for mandatory participation. propose to define the term ‘‘technical Model begins, and subsequently b. Proposed RO Model Participants component (TC)’’ to mean the included experiences a change such that the proposed exclusion criteria no longer A RO participant, a term that we RT services that are not furnished by a physician, including the provision of apply and the PGP, freestanding propose to define at § 512.205, would be radiation therapy center, or HOPD is a Medicare-enrolled PGP, freestanding equipment, supplies, personnel, and costs related to RT services. (See section located in one of the randomly selected radiation therapy center, or HOPD that CBSAs, then participation in the RO is required to participate in the RO III.C.5.c. of this proposed rule for a discussion regarding our proposed Model would be required. For example, Model pursuant to § 512.210. A RO if an HOPD is no longer classified as a participant would participate in the included RT services.) We propose to codify the terms ‘‘professional PPS-exempt hospital and the HOPD is Model as a Professional participant, located in one of the randomly selected Technical participant, or Dual component (PC)’’ and ‘‘technical component (TC)’’ at § 512.205. CBSAs, then the HOPD would become participant. an RO participant from the date that the We propose to define the term An episode of RT under the RO Model HOPD became no longer classified as a ‘‘Professional participant’’ as a RO would be furnished by either: (1) Two PPS-exempt hospital. participant that is a Medicare-enrolled separate RO participants, that is, a In the case of Professional physician group practice (PGP), Professional participant that furnishes participants and Dual participants, any identified by a single Taxpayer only the PC of an episode, and a episodes in which the initial RT Identification Number (TIN) that Technical participant that furnishes treatment planning service is furnished furnishes only the professional only the TC of an episode; or (2) a Dual to a RO beneficiary on or after the day component of RT services at either a participant that furnishes both the PC of this change would be included in the freestanding radiation therapy center or and TC of an episode. For example, if Model. In the case of Technical a HOPD. Professional participants a PGP furnishes only the PC of an participants, any episodes where the RT would be required annually to attest to episode at a HOPD that furnishes the TC service is furnished within 28 days of a the accuracy of an individual of an episode, then the PGP would be RT treatment planning service for a RO practitioner list, as described in section a Professional participant and the HOPD beneficiary and the RT service is III.C.9, provided by CMS, of all of the would be a Technical participant. In furnished on or after the day of this eligible clinicians who furnish care other words, the PGP and HOPD would change would be included in the Model. under the Professional participant’s furnish separate components of the We propose to exclude RT providers TIN. We propose to define the term same episode and would be separate and RT suppliers in Maryland due to ‘‘individual practitioner’’ to mean a participants under the Model. the unique statewide payment model Medicare-enrolled physician (identified being tested there (the Maryland Total by an NPI) who furnishes RT services to c. Proposed RO Model Participant Exclusions Cost of Care Model), in which Maryland Medicare FFS beneficiaries, and have hospitals receive a global budget. This reassigned his/her billing rights to the We propose to exclude from RO global budget includes RT services and TIN of a RO participant. We further Model participation any PGP, as such would overlap with the RO propose that an individual practitioner freestanding radiation therapy center, or Model payment; thus, we propose to under the RO Model would be HOPD that— exclude Maryland HOPDs to avoid considered a downstream participant, as • Furnishes RT only in Maryland; double payment for the same services. defined in section II.B. of this proposed • Furnishes RT only in Vermont; We propose to extend the exclusion to rule. all RT providers and RT suppliers in We propose to define the term • Furnishes RT only in U.S. Territories; Maryland to avoid creating a gaming ‘‘Technical participant’’ to mean a RO opportunity where certain beneficiaries participant that is a Medicare-enrolled • Is classified as an ambulatory surgery center (ASC), critical access HOPD or freestanding radiation therapy 25 Service location means the site of service in center, identified by a single CMS hospital (CAH), or Prospective Payment which a RO Participant or any RT provider or RT Certification Number (CCN) or TIN, System (PPS)-exempt cancer hospital; or supplier furnishes RT services.

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could be shifted away from PGPs and We further propose to codify these not propose to include non-CBSA freestanding centers to HOPDs. policies at § 512.210 of our regulations. geographies in the RO Model test. We propose to exclude RT providers We invite public comments on these However, most RT providers and RT and RT suppliers in Vermont due to the proposals. suppliers may not know in what CBSA Vermont All-Payer ACO Model, which they furnish RT services. In order to is a statewide model in which all- d. Proposed Geographic Unit of simplify the notification process to inclusive population-based payments Selection inform RT providers and RT suppliers (AIPBPs) are currently made to the whether or not they furnish RT services participating ACO for Medicare FFS We propose that the geographic unit in a selected CBSA, we are proposing to services furnished by all participating of selection for the RO Model would be use an RT provider’s or RT supplier’s HOPDs and an increasing number of OMB’s Core Based Statistical Areas service location five-digit ZIP Code participating PGPs. Given the scope of (CBSAs). Due to geographic data found on the RT provider’s or RT this model as statewide and inclusive of limitations on Medicare claim supplier’s claim submissions to CMS to all significant payers, we believe submissions, we would link RT link them to CBSAs selected under the excluding RT providers and RT providers and RT suppliers to a CBSA Model. suppliers in Vermont from the RO by using the five-digit ZIP Code of the Not all five-digit ZIP Codes fall Model is appropriate to avoid any location where RT services are entirely within OMB delineated CBSA potential interference with the testing of furnished. This would permit us to boundaries, resulting in some five-digit the Vermont All-Payer ACO Model. identify RO Model participants (see ZIP Codes assigned to two different We propose to exclude HOPDs that section III.C.3.c. of this proposed rule CBSAs. Approximately 15 percent (15 are participating in or eligible to RO Model Participant Exclusions for the percent) of five-digit ZIP Codes have portions of their addresses located in participate in the Pennsylvania Rural RT providers and RT suppliers we are more than one CBSA. If each ZIP Code Health Model. HOPDs that are proposing to exclude from the RO was assigned only to the CBSA with the participating in the model receive a Model) while still using CBSA as a largest portion of delivery locations in global budget similar to the Maryland geographic unit of selection. We further it, about 5 percent of all delivery Total Cost of Care Model. Further, we propose to codify the term ‘‘Core Based locations in ZIP Codes would be propose to extend the exclusion to Statistical Area (CBSA)’’ at § 512.205 of assigned to a different CBSA. Rather HOPDs that are eligible to participate in our regulations. than increase provider burden by the Pennsylvania Rural Health Model CBSAs are delineated by the Office of requiring submission of more detailed because they may be added to that Management and Budget and published geographic data by RT providers and RT 26 model in the future or may be included on Census.gov. A CBSA is a statistical suppliers, we propose to assign the in the evaluation comparison group for geographic area with a population of at entire five-digit ZIP Code to the CBSA that model. We would identify the least 10,000, which consists of a county where the ZIP code has the greatest CAHs and acute care hospitals that are or counties anchored by at least one portion of total addresses (business, participating or are eligible to core (urbanized area or urban cluster), residence, and other addresses) such participate in the Pennsylvania Rural plus adjacent counties having a high that each five-digit ZIP Code is clearly Health Model on a list to be updated degree of social and economic linked to a unique CBSA or non-CBSA quarterly and made available on the integration with the core (as measured geography. In the event that the portion Pennsylvania Rural Health Model’s through commuting ties with the of total addresses within the five-digit website at https://innovation.cms.gov/ counties containing the core). CBSAs ZIP Code is equal across CBSAs and initiatives/pa-rural-health-model/. are ideal for use in statistical analyses cannot be used to make the link, the The proposed RO Model is designed because they are sufficiently numerous greater portion of business addresses to test whether prospective episode to allow for a robust evaluation and are would take precedence to link the five- payments in lieu of traditional FFS also large enough to reduce the number digit ZIP Code to the CBSA. payments for RT services would reduce of RO participants in close proximity to CMS would use a five-digit ZIP Code Medicare expenditures by providing other RT providers and RT suppliers to CBSA crosswalk found in the savings for Medicare while preserving that would not be required to participate Housing and Urban Development (HUD) or enhancing quality. We believe it in the Model. CBSAs do not include the ZIP to CBSA Crosswalk file 27 to link would be inappropriate to include these extreme rural regions, but there are very each five-digit ZIP Code to a single entities for the reasons previously few RT providers and RT suppliers in CBSA. The HUD ZIP to CBSA Crosswalk described. Also, we are proposing to these areas such that, if included, the file lists the ZIP Codes (which come exclude ASCs and RT providers and RT areas would likely not generate enough from the United States Postal Service) suppliers located in the U.S. Territories, episodes to be included in the statistical that correspond with the CBSAs (which as proposed at § 512.210, due to the low analysis; further, CBSAs do contain are Census Bureau geographies) in volume of RT services that they provide. rural RT providers and RT suppliers as which those ZIP Codes exist, allowing In addition, we are proposing to exclude designated by CMS and Health these two methods of geographic CAHs and PPS-exempt cancer hospitals Resources and Services Administration identification to be linked. due to the differences in how they are (HRSA). Therefore, CBSAs would We believe that linking a five-digit paid by Medicare. capture the diversity of RT providers ZIP Code to a single CBSA would not As a result, we propose that RT and RT suppliers who may be affected substantially impact statistical estimates services furnished by these RT by the RO Model, and as such, we do for the RO Model. In addition, we providers and RT suppliers would be believe that using a service location’s excluded from participation in the RO 26 See OMB Bulletin No. 18–04 entitled ‘‘Revised five-digit ZIP Code to determine Model. If in the future we determine Delineations of Metropolitan Statistical Areas, that providers and suppliers in these Micropolitan Statistical Areas, and Combined 27 Datasets and documentation for HUD USPS Zip categories should be included in the RO Statistical Areas, and Guidance on Uses of the Code Crosswalk Files (which includes the above Delineations of These Areas,’’ https:// mentioned HUD ZIP–CBSA crosswalk file) can be Model, we would propose to revise our www.census.gov/programs-surveys/metro-micro/ found here: https://www.huduser.gov/portal/ inclusion criteria through rulemaking. about/omb-bulletins.html. datasets/usps_crosswalk.html.

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whether an RT provider or RT supplier of this proposed rule), we believe we spending, quality, and utilization. The must participate in the Model will avoid should be sufficiently powered (that is, CBSAs would be randomly selected and potential RT provider or RT supplier the sample size and the expected size of those CBSAs and the ZIP Codes selected burden by avoiding an additional the effect of the Model are both large for participation would be published on requirement that they submit claims enough at a given significance level) to the RO Model website once the final using more detailed geographic confidently show the impact of the rule is displayed. information. If finalized as proposed, Model. The comparison group would CMS would provide a look-up tool that consist of RT providers and RT 4. Proposed Beneficiary Population includes all five-digit ZIP Codes linked suppliers from randomized CBSAs We propose that a Medicare FFS to CBSAs selected in accordance with within the same strata as the selected beneficiary be included in the RO our proposed selection policy described RO participants from the participant Model if the beneficiary: in this proposed rule. This tool would group, resulting in a comparison group • Receives included RT services in a be located on the RO Model website. of an approximately equal number of five-digit ZIP Code linked to a selected Using CBSAs to identify RO CBSAs and episodes as in the CBSA from a RO participant during the participants would enable CMS to participant group that would allow for model performance period for a cancer analyze groups of RT providers and RT the effects of the RO Model to be type that meets the criteria for inclusion suppliers in areas selected to participate evaluated. Strata will be divided into in the RO Model; and in the Model and compare them to five quintiles based on the total number • At the time that the initial treatment groups of RT providers and RT of episodes within a given CBSA. The planning service of the episode is suppliers not participating in the Model. stratification would limit uneven RT furnished by a RO participant, the To the extent that CBSAs act like or provider and RT supplier and episode beneficiary: represent markets, these group analyses numbers within the participant and ++ Is eligible for Medicare Part A and would allow CMS to observe potential comparison groups of CBSAs that can enrolled in Medicare Part B; and group level, market-like effects. We have result from a simple random sample. If ++ Has traditional Medicare FFS as found group level effects important as a CBSA is randomly assigned to the his or her primary payer. context for understanding the results of participant group, then the RT providers In addition, we propose to exclude other models tested under section and RT suppliers who furnish RT from the RO Model any beneficiary 1115A of the Act. For example, services in that CBSA would be RO who, at the time that the initial stakeholders questioned whether a participants. If the CBSA is randomly treatment planning service of the model changed the overall volume of assigned to the comparison group, then episode is furnished by a RO services related to the specific model in the providers and suppliers who furnish participant: • a given area. We would not be able to RT services in that CBSA would not be Is Enrolled in any Medicare address this issue for the RO Model RO participants, but the claims they managed care organization, including without using a geographic area as the generate and the episodes constructed but not limited to Medicare Advantage unit of analysis. from those claims would be used as part plans; With respect to selecting CBSAs • Is Enrolled in a PACE plan; of the RO Model’s evaluation. • under the Model, we propose to use a After determining the sampling Is not in a Medicare hospice benefit stratified sample design based on the framework, we conducted the necessary period; or • observed ranges of episode counts in power calculations (statistical tests to Is covered under United Mine CBSAs using claims data from calendar determine the minimum sample size of Workers. years 2015–2017. We would then the participant and comparison groups Because the RO Model would randomize the CBSAs within each in the Model, designed in order to evaluate RT services furnished to stratum into participant and comparison produce robust and reliable results) beneficiaries who have been diagnosed groups until the targeted number of RO using Medicare FFS claims from January with one of the cancer types identified episodes within each group of CBSAs 1, 2015 through December 31, 2017, to as satisfying our proposed criteria for needed for a robust 28 test of the Model construct episodes and then identify a inclusion in the Model, as discussed in is reached. The primary purpose of the sufficient sample size so that results section III.C.5.a, we believe it would be evaluation is to estimate the impact of would be precise and reliable. We necessary to include only beneficiaries the Model across all participating determined that 40 percent of eligible who have at least one of the identified organizations. Larger sample sizes episodes (as defined in section III.C.5 of cancer types and who also receive RT decrease the chances that the evaluation this proposed rule) in eligible CBSAs services from RO participants. Further, would produce mistakes, that is show nationally would allow for a rigorous a key objective of the RO Model would ‘no effect’ when an effect is actually test of the RO Model that would be to evaluate if and/or how RT service present (like an instance when a smoke produce evaluation results that we can delivery changes in either the HOPD or detector fails to sound an alarm even be confident are accurately reflecting freestanding radiation therapy center though smoke is actually present) or what actually occurred in the Model setting as a result of a change in show ‘an effect’ when no effect is test, and that this size would limit the payment systems from that of FFS under actually present (like an instance when number of episodes expected in the OPPS or PFS, respectively, to that of a smoke detector is sounding an alarm participant group to no more than is prospectively determined bundled rates that suggests smoke is detected when needed for a robust statistical test of the for an episode of RT services as actually no smoke is present). Given projected impacts of the Model. described in section III.C.6.c. We that we plan to sample 40 percent of all Using randomly selected stratified propose these criteria in order to limit eligible RO episodes in eligible CBSAs CBSAs would ensure that the RT provider and RT supplier nationwide (as defined in section III.C.5 participant and comparison groups of participation in the RO Model to CBSAs would each contain beneficiaries whose RT providers and 28 ‘Robust’ in statistical terminology means that approximately 40 percent of all eligible RT suppliers would otherwise be paid we can have high confidence in the test results episodes nationally. The comparison by way of traditional FFS payments for under a broad range of conditions, for example, lower quality data, a shortened test period, or other group of CBSAs would be used to the identified cancer types. We believe unexpected complications. evaluate the impact of the RO Model on that these eligibility criteria for RO

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beneficiaries are necessary in order to completed, the 90-day period would be data was sufficiently reliable to properly evaluate this change with considered an incomplete episode and, calculate prices for prospective episode minimal intervening effects. the RO participant would receive only payments that accurately reflect the We propose that a beneficiary who the first installment of the episode average resource utilization for an meets all of these criteria, and who does payment. In the event that a beneficiary episode. These cancer types are made not trigger any of the beneficiary dies or enters hospice during an up of specific ICD–9 and ICD–10 exclusion criteria, would be called a episode, then the RO participant would diagnosis codes. For example, as shown ‘‘RO beneficiary’’. We propose to codify receive both installments of the episode in Table 1, there are cancer types for the terms ‘‘RO beneficiary,’’ ‘‘RT payment, regardless of whether the RO ‘‘breast cancer’’ and ‘‘prostate cancer,’’ provider,’’ and ‘‘RT supplier’’ at beneficiary’s course of RT has ended which are categorical terms that § 512.205. (see section III.C.7. of this proposed represent a grouping of ICD–9 and ICD– In addition, we propose to include in rule). 10 codes affiliated with those the RO Model any beneficiary We are proposing these beneficiary conditions. To identify these cancer participating in a clinical trial for RT eligibility criteria for purposes of types and their relevant diagnosis codes services for which Medicare pays determining beneficiary inclusion in to include in the Model, we identified routine costs, provided that such and exclusion from the Model. beneficiary meets all of the proposed cancers that are treated with RT. beneficiary inclusion criteria. We would 5. Proposed RO Model Episodes Using the list of cancer types and consider routine costs of a clinical trial In this proposed RO Model, Medicare relevant diagnosis codes, we analyzed to be all items and services that are would pay RO participants a site- the interquartile ranges of the episode otherwise generally available to neutral, episode-based payment amount prices across diagnosis codes within Medicare beneficiaries (that is, there for all specified RT services furnished to each cancer type to determine pricing exists a benefit category, it is not a RO beneficiary during a 90-day stability. We chose to exclude benign statutorily excluded, and there is not a episode. In this section, we first explain neoplasms and those cancers that are national non-coverage decision) that are our proposal to include criteria to add rarely treated with radiation because provided in either the experimental or or remove cancer types under the Model there were not enough episodes for 29 the control arms of a clinical trial. and their relevant diagnoses codes in reliable pricing and they were too Medicare pays routine costs by way of the Model as well as the RT services and variable to pool. FFS payments, making it appropriate to modalities that would be covered and include RT services furnished for RO not covered in an episode payment for During our review of skin cancer episodes in this case under the RO treatment of those cancer types. We then episodes, we discovered that Current ® ® Model. explain our proposal for testing a 90-day Procedural Terminology (CPT ) code The RO Model’s proposed design episode and propose the conditions that 0182T (electronic brachytherapy would not allow RO beneficiaries to must be met to trigger an episode. treatment), which was being used ‘‘opt out’’ of the Model’s pricing mainly by dermatologists to report a. Proposed Included Cancer Types methodology. A beneficiary who is treatment for non-melanoma skin included in the RO Model pursuant to We propose the following criteria for cancers, was deleted and replaced with the previously proposed criteria would purposes of including cancer types two new codes (CPT® code 0394T to have his or her RT services paid for under the RO Model. The cancer type— report high dose rate (HDR) electronic under the Model’s pricing methodology • Is commonly treated with radiation; skin brachytherapy and 0395T to report and would be responsible for the and HDR electronic interstitial or coinsurance amount as described in • Has associated current ICD–10 intracavitary treatments) in 2016. Local section III.C.6.i. Beneficiaries do have codes that have demonstrated pricing coverage determinations (LCDs) that the right to choose to receive RT stability. provide information about whether or services in a geographic area not We further propose to codify these not a particular item or service is included in the RO Model. criteria for included cancer types at covered were created and subsequently If a RO beneficiary stops meeting any § 512.230(a) of our regulation. changed during this time period. Our of the proposed eligibility criteria or We propose the following criteria for analysis suggested that the volume and triggers any of the exclusion criteria (see purposes of removing cancer types pricing of these services dropped section III.C.4. of this proposed rule) under the RO Model. significantly between 2015 and 2016, before the TC of an episode initiates, • RT is no longer appropriate to treat with pricing decreasing more than 50 then the episode would be an a cancer type per nationally recognized, percent. As a result, we did not believe incomplete episode as described in evidence-based clinical treatment that we could price episodes for skin section III.C.6.a. of this proposed rule guidelines; cancers that accurately reflect the Payments to RO participants will be • CMS discovers a ≥10 percent average resource utilization for an retrospectively adjusted to account for (≥10%) error in established national incomplete episodes during the annual episode. Thus, skin cancer was baseline rates; or excluded. reconciliation process, as described in • The Secretary determines a cancer section III.C.11. of this proposed rule. type not to be suitable for inclusion in We are proposing that the RO Model’s If traditional Medicare stops being an the Model. included cancer types would include RO beneficiary’s primary payer after the We further propose to codify these those that are commonly treated with TC of the episode has been initiated, criteria for removing cancer types at RT and that can be accurately priced for then regardless of whether the § 512.230(b) of our regulation. prospective episode payments. An up- beneficiary’s course of RT treatment was We identified 17 cancer types in to-date list of cancer types would be kept on the RO Model website. 29 The current Medicare policy on routine cost in Table 1 that meet our proposed criteria. clinical trials is described in Routine Costs in These 17 cancer types are commonly We propose to define the term Clinical Trials 100–3 section 310.1. treated with RT and Medicare claims ‘‘included cancer types’’ to mean the

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cancer types determined by the criteria set forth in § 512.230, which are included in the RO Model test.

We would maintain the list of ICD–10 We invite public comments on our participant or Dual participant furnishes codes for included cancer types under proposal. the initial treatment planning service (included in the PC), provided that a the RO Model on the RO Model website. b. Episode Length and Trigger Any addition or removal of these Technical participant or Dual proposed cancer types would be (1) Proposed Episode Length participant furnishes an RT delivery communicated via the RO Model We are proposing that the length of an service (included in the TC) within 28 website and written correspondence to episode under the RO Model be 90 days. days of the treatment planning service. RO participants. We would notify RO Based on the analysis of Medicare In other words, the relevant 90-day participants of any changes to the claims data between January 1, 2014 period would be considered an episode diagnosis codes for the included cancer and December 30, 2015, approximately only if a Technical participant or Dual types per the CMS standard process for 99 percent of beneficiaries receiving RT participant furnishes the TC to an RO announcing coding changes and update completed their course of radiation beneficiary within 28 days of when a the list on the RO Model website no within 90 days of their initial treatment Professional participant or Dual later than 30 days prior to each PY. planning service. Day 1 would be the participant furnishes the PC to such RO date of service that a Professional beneficiary. When those circumstances

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occur, the ‘‘start’’ of the episode would a Technical participant or a Dual clean period has ended. During the be the date of service that the initial participant within the following 28 clean period, a RO participant would be treatment planning service was days. The PC is attributed to the RT required to bill for RT services for the rendered. If, however, a Technical supplier of the initial radiation beneficiary in accordance with FFS participant or Dual participant does not treatment planning service. The TC is billing rules. The Innovation Center furnish the TC to an RO beneficiary attributed to the RT provider or RT would monitor the extent to which within the 28-day period, then no supplier of the initial radiation services are furnished outside of 90-day episode will have occurred and any treatment delivery service. As we episodes, including during clean payment would be made to the RO previously explained, an episode that is periods, and for the number of RO participant in accordance with our triggered would end 89 days after the beneficiaries who receive RT in incomplete episode policy. We refer date of the initial treatment planning multiple episodes. readers to sections III.C.5.b and III.C.6.a service, creating a 90 day episode. If, We invite public comment on our for an overview of our proposed episode however, a beneficiary receives an proposal. trigger and incomplete episode policies, initial treatment planning service but c. Proposed Included RT Services respectively. does not receive RT treatment from a To better understand the standard Technical participant or Dual We propose that the RO Model would length of a course of RT, we analyzed participant within 28 days, then the include most RT services furnished in Medicare claims for beneficiaries who requirements for triggering an episode HOPDs and freestanding radiation received any RT services between would not be met, and no RO episode therapy centers. Services furnished January 1, 2014 and December 30, 2015. will have occurred, and the proposed within an episode of RT usually follow Preliminary analysis showed that incomplete episode policy would take a standard, clearly defined process of average Medicare spending for radiation effect. care and generally include a treatment treatment tends to drop significantly 9 In those cases where the TC of an consultation, treatment planning, to 11 weeks following the initial RT episode is not furnished by a Dual technical preparation and special service for most diagnoses, including participant (that is, when the same RO services (simulation), treatment prostate, breast, lung, and head and participant does not furnish both the PC delivery, and treatment management, neck cancers. Furthermore, based on and the TC of an episode), the which are also categorical terms used to this data, approximately 99 percent of Professional participant would provide generally describe RT services. The beneficiaries receiving RT completed the Technical participant with a signed subcomponents of RT services have their course of radiation within 90 days radiation prescription and the final been described in the following of their initial treatment planning treatment plan, all of which is usually manner: 31 service. We intend to make a summary- done electronically. This will inform the Consultation: A consultation is an level, de-identified file titled the ‘‘RT Technical participant of when the evaluation and management (E&M) Expenditures by Time’’ available on the episode began. service, which typically consists of a RO Model’s website that supports our medical exam, obtaining a problem- findings in this preliminary analysis. (3) Proposed Policy for Multiple focused medical history, and decision Based on our analysis, for the purpose Episodes and the Clean Period making about the patient’s condition/ of establishing the national base rates Given our findings that 99 percent of care. for the PC and TC of each episode for Medicare FFS beneficiaries complete Treatment planning: Treatment each cancer type, episodes were treatment within 90 days of the initial planning tasks include determining a triggered by the occurrence of a treatment planning service, and to patient’s disease-bearing areas, treatment planning service followed by minimize any potential incentive for a identifying the type and method of a radiation treatment delivery service RO participant to extend a treatment radiation treatment delivery, specifying within 28 days of the treatment course beyond the 90-day episode in areas to be treated, and selecting planning service (HCPCS codes 77261– order to trigger a new episode, we radiation therapy treatment techniques. 77263). In addition, for the purpose of propose that another episode may not be Treatment planning often includes establishing the national base rates in triggered until at least 28 days after the simulation (the process of defining section III.C.6.c, the episodes lasted for previous episode has ended. This is relevant normal and abnormal target 89 days starting from the day after the because, while a missed week of anatomy and obtaining the images and initial treatment planning service in treatment is not uncommon, a break data needed to develop the optimal order to create a full 90-day episode. from RT services for more four weeks radiation treatment process). Treatment Based on these analyses, we are (or 28 days) generally signals the start of planning may involve marking the area proposing a 90 day episode duration. a new course of treatment.30 We refer to to be treated on the patient’s skin, (2) Proposed Episode Trigger the 28-day period after an episode has aligning the patient with localization ended, during which time a RO lasers, and/or designing immobilization Because we only want to include participant would bill for medically devices for precise patient positioning. episodes in which beneficiaries actually necessary RT services furnished to a RO Technical preparation and special receive RT services, we propose that an beneficiary in accordance with services: Technical preparation and episode would be triggered only if both Medicare FFS billing rules, as the special services include radiation dose of the following conditions are met: (1) ‘‘clean period.’’ We propose to codify planning, medical radiation physics, There is an initial treatment planning the term ‘‘clean period’’ at § 512.205 of dosimetry, treatment devices, and service (that is, submission of treatment our regulations. special services. More specifically, these planning HCPCS codes 77261–77263, If clinically appropriate, a RO services also involve building treatment all of which would be included in the participant may initiate another episode devices to refine treatment delivery and PC) furnished by a Professional for the same beneficiary after the 28-day mathematically determining the dose participant or a Dual participant; and (2) at least one radiation treatment delivery 30 CMS was advised by radiation oncologists 31 American Society for Radiation Oncology service (as listed in Table 2: List of RO consulting on the design of the Model that four (ASTRO). Basics of RO Coding. https:// Model Bundled HCPCS) is furnished by weeks signals the start of a new course of treatment. www.astro.org/Basics-of-Coding.aspx.

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and duration of radiation therapy. multiple entities to bill for treatment RO Model, we are proposing to include Radiation oncologists frequently work consultations (E&M services) for the brachytherapy radioactive elements, with dosimetrists and medical same beneficiary, whereas typically rather than omit these services, from the physicists to perform these services. only a single entity bills for RT services episodes because they are generally Radiation treatment delivery services: for a beneficiary when we limited the furnished in HOPDs and the hospitals Radiation treatment is usually furnished services considered to treatment are usually the purchasers of the via a form of external beam radiation planning, technical preparation and brachytherapy radioactive elements. therapy or brachytherapy, and includes special services, treatment delivery, and When not furnished in HOPDs, these multiple modalities. Although treatment treatment management. When services are furnished in ASCs, which generally occurs daily, the care team consultations and visits were included we are proposing to exclude from the and patient determine the specific for an analysis of professional RT Model. We invite public comments on timing and amount of treatment. The services during 2014–2016, only 18 our proposal, including comments on treating physician must verify and percent of episodes involved billing by the proposed inclusion of brachytherapy document the accuracy of treatment a single entity (TIN or CCN) as opposed radioactive sources in the episodes. delivery as related to the initial to 94 percent of episodes when treatment planning and setup consultations and visits were excluded. The RO Model payments would procedure. When consultations and visits were replace current FFS payments only for Treatment management: Radiation included for an analysis of technical RT the included RT services furnished treatment management typically services during 2014–2016, 78 percent during an episode. For the included includes review of port films, review of episodes involved billing by a single modalities, proposed in section III.C.5.d and changes to dosimetry, dose entity (TIN or CCN) as opposed to 94 of this proposed rule, the RO Model delivery, treatment parameters, review percent of episodes when consultations episode would include HCPCS codes of patient’s setup, patient examination, and visits were excluded. The difference related to radiation oncology treatment. and follow-up care. in percentages is due to the fact that Please see section III.C.7 for our Our claims analysis revealed that patients see a wide variety of doctors proposed billing guidelines. We have beneficiaries received a varying number during the course of cancer treatment, compiled a list of HCPCS codes that of consultations from different which will often involve visits and represent treatment planning, technical physicians prior to the treatment consultations. preparation and special services, planning visit, which determines the We are not proposing to include E&M treatment delivery, and treatment prescribed course of radiation therapy, services as part of the episode payment. management for the included including modality and number of RO participants would continue to bill modalities. RT services included on this treatments to be delivered. We are E&M services under Medicare FFS. list are referred to as ‘‘RO Model proposing to include treatment We would also exclude low volume Bundled HCPCS’’ when they are planning, technical preparation and RT services from the RO Model. These special services, treatment delivery, and include certain brachytherapy surgical provided during a RO Model episode treatment management as the RT procedures, neutron beam therapy, since payment for these services is services in an episode paid for by CMS, hyperthermia treatment, and bundled into the RO episode payment. and we propose to codify this at radiopharmaceuticals. We are excluding Thus, we propose to codify at § 512.270 § 512.235. E&M services are furnished these services from the Model because that these RT services would not be paid by a wide range of physician specialists they are not offered in sufficient separately during an episode. We may (for example, primary care, general amounts for purposes of evaluation. add, remove, or revise any of the oncology, others) whereas the other Given that physicians sometimes bundled HCPCS codes included in the radiation services are typically only contract with others to supply and RO Model. We would notify furnished by radiation oncologists and administer brachytherapy radioactive participants of any changes to the their team. This is reflected in the sources (or radioisotopes), we HCPCS codes per the CMS annual Level HCPCS code set used to bill for these considered omitting these services from 2 HCPCS code file. We would maintain services. In our review of claims data, the episode payment. After considering a list of the HCPCS codes included in many different types of specialists either including or excluding the RO Model on the RO Model website. furnish E&M services. It is common for brachytherapy radioelements from the BILLING CODE P

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TABLE 2: LIST OF RO MODEL BUNDLED HCPCS

HCPCS HCPCS Description Cate2ory 55920 Placement Pelvic Needles/Catheters, Brachytherapy Radiation Treatment Delivery (Brachytherapy Surgery) 57155 Placement Tandem and Opioids, Brachytherapy Radiation Treatment Delivery (Brachytherapy Surgery) 57156 Placement Vaginal Cylinder, Brachytherapy Radiation Treatment Delivery (Brachytherapy Surgery) 58346 Placement Heyman Capsules, Brachytherapy Radiation Treatment Delivery (Brachytherapy Surgery) 77014 Computed tomography guidance for placement of Medical Radiation Physics, Dosimetry, Treatment Devices, Special Services 77021 Magnetic resonance guidance for needle placement Medical Radiation Physics, Dosimetry, Treatment Devices, Special Services 77261 Radiation therapy planning Treatment Planning 77262 Radiation therapy planning Treatment Planning 77263 Radiation therapy planning Treatment Planning 77280 Set radiation therapy field Medical Radiation Physics, Dosimetry, Treatment Devices, Special Services 772'155 Set radiation therapy tleld Medical Radiation Physics, Dosimetry, Treatment Devices, Special Services 77290 Set radiation therapy field Medical Radiation Physics, Dosimetry, Treatment Devices, Special Services 77293 Respirator motion mgmt simul Medical Radiation Physics, Dosimetry, Treatment Devices, Special Services 77295 3-d radiotherapy plan Medical Radiation Physics, Dosimetry, Treatment Devices, Special Services 77299 Radiation therapy planning Medical Radiation Physics, Dosimetry, Treatment Devices, Special Services 77300 Radiation therapy dose plan Medical Radiation Physics, Dosimetry, Treatment Devices, Special Services 77301 Radiotherapy dose plan imrt Medical Radiation Physics, Dosimetry, Treatment Devices, Special Services 77306 Telethx isodose plan simple Medical Radiation Physics, Dosimetry, Treatment Devices, Special Services 77307 Telethx isodose plan cplx Medical Radiation Physics, Dosimetry, Treatment Devices, Special Services 77316 Brachytx isodose plan simple Medical Radiation Physics, Dosimetry, Treatment Devices, Special Services 77317 Brachytx isodose intermed Medical Radiation Physics, Dosimetry, Treatment Devices, Special Services 77318 Brachytx isodose complex Medical Radiation Physics, Dosimetry, Treatment Devices, Special Services 77321 Special teletx port plan Medical Radiation Physics, Dosimetry, Treatment Devices, Special Services 77331 Special radiation dosimetry Medical Radiation Physics, Dosimetry, Treatment Devices, Special Services 77332 Radiation treatment aid( s) Medical Radiation Physics, Dosimetry, Treatment Devices, Special Services 77333 Radiation treatment aid(s) Medical Radiation Physics, Dosimetry, Treatment Devices, Special Services 77334 Radiation treatment aid( s) Medical Radiation Physics, Dosimetry, Treatment Devices, Special Services 77336 Radiation physics consult Medical Radiation Physics, Dosimetry, Treatment Devices, Special Services 77338 Design mlc device for imrt Medical Radiation Physics, Dosimetry, Treatment Devices, Special Services 77170 Radiation physics consult Medical Radiation Physics, Dosimetry, Treatment Devices, Special Services 77371 Srs multisource Radiation Treatment Delivery 77372 Srs linear based Radiation Treatment Delivery 77373 Sbrt delivery Radiation Treatment Delivery 77385 Ntsty modul rad tx dlvr smpl Radiation Treatment Delivery 77386 Ntsty modul rad tx dlvr cplx Radiation Treatment Delivery 77387 Guidance for radiaj tx dlvr Radiation Treatment Delivery (Guidance) 77399 External radiation dosimetry Medical Radiation Physics, Dosimetry, Treatment Devices, Special Services 77402 Radiation treatment delivery Radiation Treatment Delivery 77407 Radiation treatment delivery Radiation Treatment Delivery 77412 Radiation treatment delivery Radiation Treatment Delivery 77417 Radiology port images(s) Radiation Treatment Delivery (Guidance) 77424 Io rad tx delivery by x-ray Radiation Treatment Delivery 77425 Io rad tx deliver by elctrns Radiation Treatment Delivery 77427 Radiation tx management x5 Treatment Management 77431 Radiation therapy management Treatment Management 77432 Stereotactic radiation trmt Treatment Management 77435 Sbrt management Treatment Management 77470 Special radiation treatment Treatment Management 77499 Radiation therapy management Treatment Management 77520 Proton trmt simple w/o comp Radiation Treatment Delivery 77522 Proton trmt simple w/comp Radiation Treatment Delivery 77523 Proton trmt intermediate Radiation Treatment Delivery 77525 Proton treatment complex Radiation Treatment Delivery 77761 Apply intrcav radiat simple Radiation Treatment Delivery 77762 Apply intrcav radiat interm Radiation Treatment Delivery 77763 Apply intrcav radiat compl Radiation Treatment Delivery 77767 Hdr rdncl skn surf brachytx Radiation Treatment Delivery 77768 Hdr rdncl skn surf brachytx Radiation Treatment Delivery 77770 Hdr rdncl ntrstl/icav brchtx Radiation Treatment Delivery 77771 Hdr rdncl ntrstl/icav brchtx Radiation Treatment Delivery 77772 Hdr rdncl ntrstl/icav brchtx Radiation Treatment Delivery 77778 Apply interstit radiat compl Radiation Treatment Delivery 77789 Apply surf ldr radionuclide Radiation Treatment Delivery

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BILLING CODE C payment rates are typically assigned to 2010, for example, the volume of d. Proposed Included Modalities services that use more expensive physician billing for radiation treatment equipment. Additionally, newer increased 8.2 percent, while Medicare We propose to include the following treatments have traditionally been Part B spending on RT increased 216 RT modalities in the Model: Various assigned higher payment. Researchers percent.34 Most of the increase in the types of external beam RT, including 3- have indicated that resource-based 2000 to 2010 time period was due to the dimensional conformal radiotherapy payments may encourage health care adoption and uptake of IMRT. From (3DCRT), intensity-modulated providers to purchase higher priced 2010 to 2016, spending and volume for radiotherapy (IMRT), stereotactic equipment and furnish higher-cost PBT in FFS Medicare grew rapidly,35 radiosurgery (SRS), stereotactic body services, if they have a sufficient driven by a sharp increase in the radiotherapy (SBRT), and proton beam volume of patients to cover their fixed therapy (PBT); intraoperative number of proton beam centers and costs.32 Higher payment rates for radiotherapy (IORT); image-guided Medicare’s relatively broad coverage of services involving certain treatment radiation therapy (IGRT); and this treatment. While we cannot assess modalities may encourage use of those brachytherapy. We are proposing to through claims data what caused this modalities over others.33 include all of these modalities because they are the most commonly used to Medicare payment for RT has 34 Shen, X., Showalter, T. N., Mishra, M.V., Barth, increased substantially. From 2000 to S., Rao, V., Levin, D., & Parker, L. (2014). Radiation treat the 17 included cancer types and oncology services in the modern era: Evolving including these modalities would allow patterns of usage and payments in the office setting us to determine whether the RO Model 32 Falit, B. P., Chernew, M. E., & Mantz, C.A. for Medicare patients from 2000 to 2010. Journal of is able to impact RT holistically rather (2014). Design and implementation of bundled Oncology Practice, 10(4), e201–e207. payment systems for cancer care and RT. 35 Spending in PBT rose from $47 million to $115 than testing a limited subset of services. International Journal of Radiation million, and the number of treatment sessions for Because the OPPS and PFS are Oncology• Biology• Physics, 89(5), 950–953. PBT rose from 47,420 to 108,960, during that resource-based payment systems, higher 33 Ibid. period.

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increase in PBT, we can monitor They concluded that there are many national base rates represents the changes in the utilization of treatment policy tools, including new payment historical average cost for an episode of modalities during the course of the models, that CMS could consider care for each of the included cancer Model. The aforementioned increase in adopting to reduce the use of low-value types. The calculation of these rates PBT volume may depend on a variety of services. Given the continued debate would be based on Medicare FFS claims factors. around the benefits of PBT, and paid during the CYs 2015–2017 that are The RO Model’s episode payment is understanding that the PBT is more included under an episode where the designed, in part, to give RT providers costly, we believe that it would be initial treatment planning service and RT suppliers greater predictability appropriate to include in the RO occurred during the CYs 2015–2017 as in payment and greater opportunity to Model’s test, which is designed to described in section III.C.6.b. If an clinically manage the episode, rather evaluate, in part, site neutral payments episode straddles calendar years, the than being driven by FFS payment for RT services. We invite public episode and its claims are counted in incentives. The design of the payment comment our proposal to include PBT the calendar year for which the initial model groups together different in the RO Model. treatment planning service is furnished. modalities for specific cancer types, We are considering excluding PBT We exclude those episodes that do not often with variable costs, into a single from the included modalities in meet the criteria described in section payment that reflects average treatment instances where a RO beneficiary is III.C.5 of this proposed rule. From those costs. The Model would include an participating in a federally-funded, episodes, we would then calculate the historical experience adjustment which multi-institution, randomized control amount CMS paid on average to would account for RO participant’s clinical trial for PBT so that further providers for the PC and TC for each of historical care patterns, including a RO clinical evidence assessing its health the included cancer types in the HOPD participant’s historical use of more benefit comparable to other modalities setting, creating the Model’s national expensive modalities, and certain can be gathered. We invite public base rates. Unless a broad rebasing is factors that are beyond a provider’s comment on whether or not the RO done after a later PY in the Model, these control. We believe that applying the Model should include RO beneficiaries national base rates would be fixed same payment for the most commonly participating in federally-funded, multi- throughout the model performance used RT modalities would allow institution, randomized control clinical period. physicians to pick the highest-value trials for PBT. In the second step, we would apply a modalities. trend factor to the 34 different national Given the goals of the RO Model as 6. Proposed Pricing Methodology base rates to update those amounts to well as the proposed payment design, a. Overview reflect current trends in payment for RT we believe it is important to treat all services and the volume of those modalities equally. The proposed pricing methodology services outside of the Model under With respect to PBT, there has been describes the data and process used to OPPS and PFS. We propose to define debate regarding the benefits of proton determine the amounts for participant- the term ‘‘trend factor’’ to mean an beam relative to other, less expensive specific professional episode payments adjustment applied to the national base modalities. The Institute for Clinical and participant-specific technical rates that updates those rates to reflect and Economic Review (ICER) evaluated episode payments for each included current trends in the OPPS and PFS the evidence of the overall net health cancer type. We propose to define the rates for RT services. We propose to benefit (which takes into account term ‘‘participant-specific professional codify the term ‘‘trend factor’’ at clinical effectiveness and potential episode payment’’ as a payment made § 512.205 of our regulations. In this step, harms) of proton beam therapy in by CMS to a Professional participant or we would calculate separate trend comparison with its major treatment Dual participant for the provision of the factors for the PC and TC of each cancer alternatives for various types of professional component of RT services type using data from HOPDs and cancer.36 ICER concluded that PBT has furnished to a RO beneficiary during an freestanding radiation therapy centers superior net health benefit for ocular episode, which is calculated as set forth not participating in the Model. More tumors and incremental net health in proposed § 512.255. We further specifically, the calculations would benefit for adult brain and spinal tumors propose to codify this term, update the national base rates using the and pediatric cancers. ICER judged that ‘‘participant-specific professional most recently available claims data of proton beam therapy is comparable with episode payment,’’ at § 512.205 of our those non-participating providers and alternative treatments for prostate, lung, regulations. suppliers and the volume at which they and liver cancer, although the strength We propose to define the term billed for RT services as well as their of evidence was low for these ‘‘participant-specific technical episode corresponding payment rates. Adjusting conditions. In a June 2018 report to payment’’ as a payment made by CMS the national base rates with a trend Congress, MedPAC discussed Medicare to a Technical participant or Dual factor would help ensure payments coverage policy and use of low-value participant for the provision of the made under the Model appropriately care and examined services, including technical component of RT services to a reflect changes in treatment patterns PBT, which lack evidence of RO beneficiary during an episode, and payment rates that have occurred comparative clinical effectiveness and which is calculated as set forth in under OPPS and PFS. are therefore potentially low value.37 proposed § 512.255. We further propose In the third step, we would adjust the to codify this term, ‘‘participant-specific 34 now-trended national base rates to 36 Ollendorf, D.A., J.A. Colby, and S. D. Pearson. technical episode payment,’’ at account for each Participant’s historical 2014. Proton beam therapy. Report prepared by the § 512.205 of our regulations. Institute for Clinical and Economic Review for the experience and case mix history. The Health Technology Assessment Program, There are eight primary steps to the historical experience and case mix Washington State Health Care Authority. Olympia, proposed pricing methodology. In the adjustments account for providers’ WA: Washington State Health Care Authority. first step, we would create a set of historical care patterns and certain https://icer-review.org/wp-content/uploads/2014/ 07/pbt_final_report_040114.pdf. national base rates for the PC and TC of factors that are beyond a provider’s 37 http://medpac.gov/docs/default-source/reports/ the included cancer types, yielding 34 control, which vary systematically jun18_ch10_medpacreport_sec.pdf. different national base rates. Each of the among providers and suppliers so as to

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warrant adjustment in payment. There PC or TC of that RO beneficiary after the is, national base rates, trend factors, case would be one professional and/or one episode. We propose to codify mix and historical experience technical case mix adjustment per RO ‘‘duplicate RT service’’ at § 512.205. An adjustments, withholds, discount participant depending on the type of incomplete episode means the factors, geographic adjustment, component the RO Participant furnished circumstances in which an episode does beneficiary coinsurance, and during the 2015–2017 period, just as not occur because: (1) A Technical sequestration) figures into these there would be one professional and/or participant or a Dual participant does amounts. We also intend to provide a one technical historical experience not furnish a technical component to a summary-level, de-identified file titled adjustment per RO participant, RO beneficiary within 28 days following the ‘‘RO Episode File (2015–2017),’’ on depending on the type of component the a Professional participant or the Dual the RO Model’s website to further RO Participant furnished during the participant furnishing an RT treatment facilitate understanding of the RO 2015–2017 period. We would generate planning service to that RO beneficiary; Model’s pricing methodology. each RO participant’s case mix or (2) traditional Medicare stops being b. Proposal To Construct Episodes Using adjustments using an ordinary least the primary payer at any point during Medicare FFS Claims and Calculate squares (OLS) regression model that the relevant 90-day period the RO Episode Payment predicts payment based on a set of beneficiary; or (3) a RO beneficiary stops beneficiary characteristics found to be meeting the beneficiary population We would construct episodes based strongly correlated to cost. In contrast, criteria under § 512.215(a) or triggers the on dates of service for Medicare FFS we would generate each RO beneficiary exclusion criteria under claims paid during the CYs 2015–2017 participant’s historical experience § 512.215(b) before the technical as well as claims that are included adjustments based on Winsorized component of an episode initiates. under an episode where the initial payment amounts for episodes We would also adjust for a quality treatment planning service occurred attributed to the RO participant during withhold for the professional during the CYs 2015–2017 as described the calendar years 2015–2017. The component of the episode. This in section III.C.3.d. We would exclude historical experience adjustments for withhold would allow the Model to those episodes that do not meet the each RO participant would be further include quality measure results as a criteria described in section III.C.5 of weighted by an efficiency factor. The factor when determining payment to this proposed rule. Each episode and its efficiency factor measures if a RO participants under the terms of the corresponding payment amounts, one participant’s episodes (from the APM, which is one of the criteria for an for the PC and one for the TC, would retrospectively constructed episodes APM to qualify as an Advanced APM as represent the sum totals of calculated from 2015–2017 claims data) have specified in 42 CFR 414.1415(b)(1). We payment amounts for the professional historically been more or less costly would adjust for a patient experience services and the technical services of than the national base rates, and this withhold for the technical component of the radiation treatment furnished over a determines the weight at which each RO the episode starting in PY3 to account defined 90-day period as described in participant’s historical experience for patient experience in the Model. We section III.C.5.b. We would calculate the adjustments are applied to the trended would then apply all of these payment amounts for the PC and TC of national base rates. adjustments, as appropriate to each RO each episode as the product of: (a) The In the fourth step, we would further participant’s trended national base rates. OPPS or PFS national payment rates for adjust payment by applying a discount In the sixth step, we would apply each of the RT services included in the factor. The discount factor, the set geographic adjustments to payments. In Model multiplied by (b) the volume of percentage by which CMS reduces an the seventh and final eighth step, we each professional or technical RT episode payment amount, after the trend would apply beneficiary coinsurance service included on a paid claim line factor and adjustments have been and a 2 percent adjustment for during each episode. We would neither applied, but before standard CMS sequestration to the trended national Winsorize nor cap payment amounts adjustments including the geographic base rates that have been adjusted as nor adjust for outliers in this step. practice cost index (GPCI), described in steps three through six, So that all payment amounts are in sequestration, and beneficiary cost- yielding participant-specific payment 2017 dollars, we would convert 2015 sharing, would reserve savings for amounts for the provision of the PC and payment amounts to 2017 by Medicare and reduce beneficiary cost- TC of each included cancer type in the multiplying: (a) The 2015 payment sharing. We propose to codify the term Model. We would calculate a total of 34 amounts by the ratio of (b) average ‘‘discount factor’’ at § 512.205. participant-specific professional and payment amounts for episodes that In the fifth step, we would further technical episode payment amounts for initiated in 2017 to (c) average payment adjust payment by applying an incorrect Dual participants, whereas we would amounts for episodes that initiated in payment withhold, and either a quality only calculate 17 participant-specific 2015. We would apply this same withhold or a patient experience professional episode payment amounts process for episodes starting in 2016. To withhold, depending on the type of or 17 participant-specific technical weigh the most recent observations component the RO participant furnished episode payment amounts for more heavily than those that occurred in under the Model. The incorrect payment Professional participants and Technical earlier years, we would weight episodes withhold would reserve money for participants, since they furnish only the that initiated in 2015 at 20 percent, purposes of reconciling duplicate RT PC or TC, respectively. episodes that initiated in 2016 at 30 services and incomplete episodes Following this description of the data percent, and episodes that initiated in during the reconciliation process, which and process used to determine the 2017 at 50 percent. we discuss further in section III.C.11. amounts for participant-specific Conversion of 2015 and 2016 payment We propose to define the term professional episode payments and amounts to 2017 dollars would be done ‘‘duplicate RT service’’ to mean any participant-specific technical episode differently, depending on which step of included RT service (as identified at payments for each included cancer type the pricing methodology is being § 512.235) that is furnished to a single is a pricing example for an episode of calculated. For instance, episode RO beneficiary by a RT provider or RT lung cancer. We provide this example to payments for episodes used to calculate supplier or both that did not initiate the show how each pricing component (that national base rates and case mix

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regression models would only be • Episodes without positive (>$0) meet the following criteria: (1) Episodes furnished in the HOPD setting, and total payment amounts for professional initiated in 2015–2017; (2) episodes consequently, for purposes of services or technical services; attributed to a HOPD; and (3) during an calculating the national base rates and • Episodes assigned a cancer type not episode, the majority of technical case mix regression models, the identified as cancer types that meet our services were provided in a HOPD (that conversion of episode payment amounts criteria (see Table 1); is, more technical services were • to 2017 dollars would be based on Episodes that are not assigned a provided in a HOPD than in a average payments of episodes from only cancer type; • freestanding radiation therapy center). the HOPD setting. On the other hand, Episodes with RT services OPPS payments have been more stable furnished in Maryland, Vermont, or a episode payments for episodes used to over time and have a stronger empirical calculate the historical experience U.S. Territory; • foundation than those under the PFS. adjustments would be furnished in both Episodes in which a PPS-exempt cancer hospital furnishes the technical The OPPS coding and payments for the HOPD and freestanding radiation radiation oncology have varied less year therapy center settings (that is, all component (is the attributed technical provider); over year than those in the PFS for the episodes nationally), and consequently, • applicable time period. In addition, for purposes of calculating the historical Episodes in which a Medicare beneficiary does not meet the eligibility generally speaking, the OPPS payment experience adjustments, the conversion amounts are derived from information of episode payment amounts to 2017 criteria proposed in section III.C.4. We are proposing to exclude episodes from hospital cost reports, which are dollars would be based on average without positive (>$0) total payment based on a stronger empirical payments of all episodes nationally amounts for professional services or foundation that the PFS payment from both the HOPD and freestanding technical services, since we would only amounts for services involving capital radiation therapy center settings. use episodes where the RT services equipment. were not denied and Medicare made c. Proposed National Base Rates CMS would publish the national base payment for those RT services. We are rates and provide each RO participant We propose to define the term proposing to exclude episodes that are ‘‘national base rate’’ to mean the total not assigned a cancer type and episodes its participant-specific professional payment amount for the relevant assigned a cancer type not on the list of episode payment and/or its participant- component of each episode before Included Cancer Types, since the RO specific technical episode payment for application of the trend factor, discount Model evaluates the furnishing of RT each cancer type no later than 30 days factor, adjustments, and applicable services to beneficiaries who have been before the start of the PY in which withholds for each of the proposed diagnosed with one of the included payments in such amounts would be included cancer types. We further cancer types. The remaining proposals made. propose to codify this term at § 512.205 listed in this section exclude episodes Our proposed national base rates for of our regulations. that are in accordance with proposals the model performance period based on set forth in section III.C.5. The following episodes would be the criteria set forth for cancer type excluded from calculations to determine (1) Proposed National Base Rate inclusion are summarized in Table 3. the national base rates: Calculation Methodology BILLING CODE P • Episodes with any services When calculating the national base furnished by a CAH; rates, we would only use episodes that

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TABLE 3 -NATIONAL BASE RATES BY CANCER TYPE (in 2017 DOLLARS)

RO Model- Specific Placeholder Professional or Codes38 Technical Cancer Type Base Rate MXXXX Professional Anal Cancer $2,968 MXXXX Technical Anal Cancer $16,006 MXXXX Professional Bladder Cancer $2,637 MXXXX Technical Bladder Cancer $12,556 MXXXX Professional Bone Metastases $1,372 MXXXX Technical Bone Metastases $5,568 MXXXX Professional Brain Metastases $1,566 MXXXX Technical Brain Metastases $9,217 MXXXX Professional Breast Cancer $2,074 MXXXX Technical Breast Cancer $9,740 MXXXX Professional Cervical Cancer $3,779 MXXXX Technical Cervical Cancer $16,955 MXXXX Professional CNS Tumor $2,463 MXXXX Technical CNS Tumor $14,193 MXXXX Professional Colorectal Cancer $2,369 MXXXX Technical Colorectal Cancer $11,589 MXXXX Professional Head and Neck Cancer $2,947 MXXXX Technical Head and Neck Cancer $16,708 MXXXX Professional Kidney Cancer $1,550 MXXXX Technical Kidney Cancer $7,656 MXXXX Professional Liver Cancer $1,515 MXXXX Technical Liver Cancer $14,650 MXXXX Professional Lung Cancer $2,155 MXXXX Technical Lung Cancer $11,451 MXXXX Professional Lymphoma $1,662 MXXXX Technical Lymphoma $7,444 MXXXX Professional Pancreatic Cancer $2,380 MXXXX Technical Pancreatic Cancer $13,070 MXXXX Professional Prostate Cancer $3,228 MXXXX Technical Prostate Cancer $19,852 MXXXX Professional Upper GI Cancer $2,500 MXXXX Technical Upper GI Cancer $12,619 MXXXX Professional Uterine Cancer $2,376 MXXXX Technical Uterine Cancer $11,221

BILLING CODE C radiation therapy centers not volume for RT services outside of the d. Proposal To Apply Trend Factors to participating in the Model. We propose Model under OPPS and PFS. National Base Rates that the 34 separate trend factors would For the PC of each included cancer be updated and applied to the national type and the TC of each included cancer We would next apply a trend factor to base rates prior to the start of each PY type, we would calculate a ratio of: (a) the 34 different national base rates in Volume-weighted FFS payment rates for Table 3. For each PY, we would (for which they would apply) so as to account for trends in payment rates and calculate separate trend factors for the 38 The final HCPCS codes specific to the RO PC and TC of each cancer type using Model would be published in the CY2020 Level 2 data from HOPDs and freestanding HCPCS code file.

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RT services included in that component We propose to use this trend factor The regression models generate for that cancer type in the upcoming PY methodology as part of the RO Model’s coefficients, which are values that (that is, numerator) to (b) volume- pricing methodology. describe how change in episode weighted FFS payment rates for RT payment corresponds to the unit change e. Proposal To Adjust for Case Mix and services included in that component for of the case mix variables. From the Historical Experience that cancer type in the most recent coefficients, we would determine a RO baseline year (that is, the denominator), After applying the proposed trend participant’s predicted payments, or the which would be FFS rates from 2017. factor in section III.C.6.d, we propose to payments predicted under the FFS To calculate the numerator, we would adjust the 34 trended national base rates payment system for an episode of care multiply: (a) The average number of to account for each RO participant’s as a function of the characteristics of the times each HCPCS code (relevant to the historical experience and case mix RO participant’s beneficiary population. component and the cancer type for history. For PY1, these predicted payments would be based on episode data from which the trend factor would be (1) Proposed Case Mix Adjustments applied) was furnished for the most 2015 to 2017. These predicted payments recent calendar year with complete The cost of care can vary according to would be summed across all episodes data 39 by (b) the corresponding FFS many factors that are beyond a attributed to the RO participant to payment rate (as paid under OPPS or provider’s control, and the presence of determine a single predicted payment PFS) for the upcoming performance certain factors, otherwise referred to for the PC or the TC. This process would year. here as case mix variables, may vary be carried out separately for the PC and systematically among providers and the TC. To calculate the denominator, we warrant adjustment in payment. For this We would then determine a RO would multiply: (a) The average number reason, we propose to apply a RO participant’s expected payments or the of times each HCPCS code (relevant to participant-specific case mix adjustment payments expected when a participant’s the component and the cancer type for for the PC and the TC that would be case mix (other than cancer type) is not which the trend factor would be applied to the trended national base considered in the calculation. To do applying) was furnished in 2017, the rates. this, we would use the average most recent year used to calculate the Winsorized episode payment made for national base rates by (b) the We consulted clinical experts in each cancer type in the national corresponding FFS payment rate in radiation oncology concerning potential beneficiary profile. These average 2017. The volume of HCPCS codes case mix variables believed to be Winsorized episode payments by cancer determining the numerator and predictive of cost. We then tested and type would be applied to all episodes denominator would be derived from evaluated these potential case mix attributed to the RO participant to non-participant episodes that would be variables and found several variables determine the expected payments. otherwise eligible for Model pricing. For (cancer type; age; sex; presence of a These expected payments would be example, for PY1, we would calculate major procedure; death during the first summed across all episodes attributed the trend factor as: 30 days, second 30 days, or last 30 days of the episode; and presence of to a RO participant to determine a single 2020 Trend factor = (2017 volume * chemotherapy) to be strongly and expected payment for the PC or the TC. 2020 corresponding FFS rates as reliably predictive of cost under the FFS The difference between a RO paid under OPPS or PFS)/(2017 payment system. participant’s predicted payment and a volume * 2017 corresponding FFS Based on the results of this testing, we RO participant’s expected payment, rates as paid under OPPS or PFS) propose to develop a case mix divided by the expected payment, We would then multiply: (a) The adjustment, measuring the occurrence of would constitute either the PC or the TC trend factor for each national base rate the case mix variables among the case mix adjustment for that RO by (b) the corresponding national base beneficiary population that each RO participant. Mathematically this would rate for the PC and TC of each cancer participant has treated historically (that be expressed as follows: type from Step 1, yielding 34 trended is, among beneficiaries whose episodes Case mix adjustment = (Predicted ¥ national base rates. The trended have been attributed to the RO payment Expected payment)/ national base rates for 2020 would be participant during 2015–2017) Expected payment made available on the RO Model’s compared to the occurrence of these Neither the national beneficiary website once CMS issues the CY 2020 variables in the national beneficiary profile nor the regression model’s OPPS and PFS final rules that establish profile. The national beneficiary profile coefficients would change over the payment rates for the year. is developed from the same episodes course of the Model’s performance To the extent that CMS introduces used to determine the Model’s national period. The coefficients would be new HCPCS codes that CMS determines base rates, that is 2015–2017 episodes applied to a rolling 3-year set of should be included in the Model, we attributed to all HOPDs nationally. We episodes attributed to the RO propose to cross-walk the volume based would first Winsorize, or cap, the participant so that a RO participant’s on the existing set of codes to any new episode payments in the national case mix adjustments take into account set of codes as we do in the PFS rate- beneficiary profile at the 99th and 1st more recent changes in the case mix of setting process.40 percentiles, with the percentiles being their beneficiary population. For identified separately by cancer type. We example, we would use data from 2015– would use OLS regression models, one 39 For 2020 (PY1), the most recent year with 2017 for PY1, data from 2016–2018 for complete episode data would be 2017; for 2021 for the PC and one for the TC, to PY2, data from 2017–2019 for PY3, etc. (PY2), the most recent year with complete episode identify the relationship between data would be 2018. episode payments and the case mix (2) Proposed Historical Experience 40 The process of cross-walking the volume from variables. The regression models would Adjustments and Efficiency Factor a previous set of codes to the new set of codes in To determine historical experience rate-setting for the PFS was most recently explained measure how much of the variation in in the CY 2013 PFS Final Rule, 77 FR 68891, episode payments can be attributed to adjustments for a RO participant we 68996–68997. variation in the case mix variables. would use episodes attributed to the RO

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participant that initiated during 2015– characteristics of the RO participant’s episode payments for Professional 2017. We would calculate a historical beneficiary population. The historical participants and Technical participants. experience adjustment for the PC (that experience adjustments would be We propose to use these case mix is, a professional historical experience weighted differently and therefore, adjustments, historical experience adjustment) and the TC (that is, a applied to payment (that is the trended adjustments, and efficiency factors to technical historical experience national base rates after the participant- calculate the adjustments under the RO adjustment) based on attributed specific case mix adjustments have been Model’s pricing methodology. episodes. For purposes of determining applied) differently, depending on these historical experience adjustments, we categories. To do this, we would use an (4) Proposal for HOPD or Freestanding would use episodes as described in efficiency factor. Efficiency factor means Radiation Therapy Center With Fewer section III.C.6.b (that is, all episodes the weight that a RO participant’s Than Sixty Episodes During 2015–2017 nationally), except we would Winsorize, historical experience adjustments are Period or cap, episode payments attributed to given over the course of the Model’s the RO participant at the 99th and 1st performance period, depending on Under this proposed rule, if a HOPD percentiles. These Winsorization whether the RO participant’s historical or freestanding radiation therapy center thresholds would be the same experience adjustments fall into the (identified by a CCN or TIN) furnishes Winsorization thresholds used in the historically efficient or historically RT services during the model case mix adjustment calculation. We inefficient category. performance period within a selected CBSA and is required to participate in would then sum these payments For RO participants with historical the Model because it meets eligibility separately for the PC and TC. As with experience adjustments with a value requirements, but has fewer than 60 the case mix adjustments, the historical greater than 0.0, the efficiency factor episodes attributed to it during the experience adjustments would not vary would decrease over time to reduce the by cancer type. impact of historical practice patterns on 2015–2017 period, then the RO The historical experience adjustment payment over the Model’s performance participant’s participant-specific for the PC would be calculated as the period. More specifically, for RO professional episode payment and difference between: The sum of (a) participants with a PC or TC historical technical episode payment amounts Winsorized payments for episodes experience adjustment with a value would equal the trended national base attributed to the RO participant during greater than 0.0, the efficiency factor rates in PY1. In PY2, if an RO 2015–2017 and (b) the summed would be 0.90 in PY1, 0.85 in PY2, 0.80 participant with fewer than 60 episodes predicted payments from the case mix in PY3, 0.75 in PY4 and 0.70 in PY5. attributed to it during the 2015–2017 adjustment calculation, which would For those RO participants with a PC or period continues to have fewer than then be divided by (c) the summed TC historical experience adjustment sixty episodes attributed to it during the expected payments used in the case mix with a value equal to or less than 0.0, 2016–2018 period, then the RO adjustment calculations. We would the efficiency factor would be fixed at participant’s participant-specific repeat these same calculations for the 0.90 over the Model’s performance professional episode payment and historical experience adjustment for the period. technical episode payment amounts TC. Mathematically, for episodes would continue to equal the trended attributed to the RO participant, this (3) Proposal To Apply the Adjustments national base rates in PY2. However, if would be expressed as: To apply the case mix adjustment, the the RO participant had 60 or more Historical experience adjustment = historical experience adjustment, and attributed episodes during the 2016– ¥ (Winsorized payments Predicted the efficiency factor as described in 2018 period, then the RO participant’s payments)/Expected payments section III.C.6.e to the trended national participant-specific professional episode Based on our proposed calculation, if base rates detailed in Step 2, for the PC payment and technical episode payment a RO participant’s Winsorized episode we would multiply: (a) The amounts for PY2 would equal the payments (determined from the corresponding historical experience trended national base rates with the case retrospectively constructed episodes adjustment by (b) the corresponding mix adjustment added. In PY3–PY5, we from 2015–2017 claims data) are equal efficiency factor, and then add (c) the would reevaluate those same RO to or less than the predicted payments corresponding case mix adjustment and participants as we did in PY2 to used to determine the case mix (d) the value of one. This formula determine the number of episodes in the adjustments, then it would have creates a combined adjustment that can rolling three year period used in the historical experience adjustments with a be multiplied with the national base case mix adjustment for that value equal to or less than 0.0, and be rates. Mathematically this would be performance year (for example, PY3 categorized as historically efficient expressed as: would be 2017–2019). RO participants compared to the payments predicted that continue to have fewer than 60 under the FFS payment system for an Combined Adjustment = (Historical attributed episodes in the rolling three episode of care as a function of the experience adjustment * Efficiency year period used in the case mix characteristics of the RO participant’s factor) + Case mix adjustment + 1.0 adjustment for that performance year beneficiary population. Conversely, if a The combined adjustment would then would continue to have participant- RO participant’s episode payments are be multiplied by the corresponding specific professional episode payment greater than the predicted payments trended national base rate from Step 2 and technical episode payment amounts used to determine the case mix for each cancer type. We would repeat that equal the trended national base adjustments, then it would have these calculations for the corresponding rates, whereas those that have 60 or historical experience adjustments with a case mix adjustment, historical more attributed episodes would have value greater than 0.0 and be experience adjustment, and efficiency participant-specific professional episode categorized as historically inefficient factor for the TC, yielding a total of 34 payment and technical episode payment compared to the payments predicted RO participant-specific episode amounts that equal the trended national under the FFS payment system for an payments for Dual participants and a base rates with the case mix adjustment episode of care as a function of the total of 17 RO participant-specific added.

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(5) Proposal To Apply Adjustments for participants with respect to reduction in CMS, as reflected on a reconciliation HOPD or Freestanding Radiation payment. report. We propose to codify the term Therapy Center With a Merger, We propose to apply these discount ‘‘repayment amount’’ at § 512.205 of our Acquisition, or Other New Clinical or factors to the RO participant-adjusted regulations. In addition, we propose to Business Relationship, With or Without and trended payment amounts for each define the term ‘‘reconciliation report’’ a CCN or TIN Change of the RO Model’s performance years. to mean the annual report issued by We are proposing that a new TIN or g. Proposal To Apply Withholds CMS to a RO participant for each CCN that results from a merger, performance year, which specifies the We propose to withhold a percentage RO participant’s reconciliation payment acquisition, or other new clinical or of the total episode payments, that is the amount or repayment amount. We business relationship that occurs prior payment amounts after the trend factor, further propose to codify the term to October 3, 2024 meets the Model’s adjustments, and discount factor have ‘‘reconciliation report’’ at § 512.205. proposed eligibility requirements been applied to the national base rates, discussed in section III.C.3. If the new to address payment issues and to create (2) Proposed Quality Withhold TIN or CCN begins to furnish RT incentives for furnishing high quality, We propose to also apply a 2 percent services within a selected CBSA, then it patient-centered care. We outline our quality withhold for the PC to the must participate in the Model. We are proposals for three withhold policies in applicable trended national base rates proposing this policy in order to prevent this section of this proposed rule. after the case mix and historical HOPDs and freestanding radiation experience adjustments and discount therapy centers from engaging in (1) Proposed Incorrect Payment Withhold factor have been applied. This would mergers, acquisitions, or other new allow the Model to include quality clinical or business relationships so as We propose to withhold 2 percent of measure results as a factor when to avoid participating in the Model. the total episode payments for both the determining payment to participants The RO Model requires advanced PC and TC of each cancer type. This 2 under the terms of the APM, which is notification so that the appropriate percent would reserve money to address one of the Advanced APM criteria as adjustments are made to the new or overpayments that may result from two codified in 42 CFR 414.1415(b)(1). existing RO participant’s participant- situations: (1) Duplicate RT services as Professional participants and Dual specific professional episode payment described in section III.C.6.a; and (2) participants would be able to earn back and participant-specific technical incomplete episodes as described in up to the 2 percent withhold amount episode payment amounts. This section III.C.6.a of this proposed rule. each performance year based on their requirement for the RO Model is the We are proposing a withhold for these aggregate quality score (AQS). We same requirement as proposed at two circumstances in order to decrease propose to define the term ‘‘AQS’’ to § 512.180(c), except that under the RO the likelihood of CMS needing to recoup mean the numeric score calculated for Model, RO participants must also payment, which could cause each RO participant based on its provide a notification regarding a new administrative burden on CMS and performance on, and reporting of, clinical relationship that may or may potentially disrupt a RO participant’s proposed quality measures and clinical constitute a change in control. If there cash flow. We believe that a 2 percent data, as described in section III.C.8.f, is sufficient historical data from the incorrect payment withhold would set which is used to determine the amount entities merged, absorbed, or otherwise aside sufficient funds to capture a RO of a RO participant’s quality changed as a result of this new clinical participant’s duplicate RT services and reconciliation payment amount. We or business relationship, then this data incomplete episodes during the further propose to codify this term at would be used to determine adjustments reconciliation process. We anticipate § 512.205 of our regulations. The annual for the new or existing TIN or CCN. For that duplicate RT services requiring reconciliation process described in our proposed policy regarding change in reconciliation will be uncommon, and section III.C.11 would determine how legal business name and change in that few overpayments for such services much of the 2 percent withhold a control provisions, we refer readers to would therefore be subject to our Professional participant or Dual discussion in section II.L and proposed proposed reconciliation process. Claims participant would receive back. regulations at § 512.180(b) and (c). data from January 1, 2014 through December 31, 2016 show less than 6 (3) Proposed Patient Experience f. Proposal To Apply a Discount Factor percent of episodes had more than one Withhold After applying participant-specific unique TIN or CCN billing for either We would withhold 1 percent for the adjustments under section III.C.6.e to professional RT services or technical RT TC to the applicable trended national the trended national base rates, we services within a single episode. base rates after the case mix and would next deduct a percentage Similarly, our analysis showed that it is historical experience adjustments and discount from those amounts for each uncommon that a RT provider or RT discount factor have been applied performance year. The discount factor supplier does not furnish a technical starting in PY3 (January 1, 2022 through would not vary by cancer type. The component RT service to a beneficiary December 31, 2022) to account for discount factor for the PC would be 4 within 28 days of when a radiation patient experience in the Model. percent. The discount factor for the TC oncologist furnishes an RT treatment Technical participants and Dual would be 5 percent. We are proposing planning service to such RO beneficiary. participants would be able to earn back the 4 and 5 percent discounts based on We would use the annual up to the full amount of the patient discounts in other models tested under reconciliation process described in experience withhold for a given PY section 1115A and private payer section III.C.11 to determine whether a based on their results from the patient- models. We believe these figures for the RO participant is eligible to receive back reported Consumer Assessment of discount factor, four and 5 percent for the full 2 percent withhold amount, a Healthcare Providers and Systems the PC and TC, respectively, strike an portion of it, or must repay funds to (CAHPS® Cancer Care Survey) Cancer appropriate balance in creating savings CMS. We propose to define the term Care Survey for Radiation Therapy as for Medicare while not creating ‘‘repayment amount’’ to mean the described in section III.C.8.b. of this substantial financial burden on RO amount owed by a RO participant to proposed rule.

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Like the incorrect payment and would be split into RO Model-specific RO Model. RO beneficiaries would pay quality withholds, the annual Work, PE, and MP RVUs. The 2015– 20 percent of each of the bundled PC reconciliation process described in 2017 episodes that had the majority of and TC payments for their cancer type, section III.C.11. of this proposed rule radiation treatment services furnished at regardless of what their total would determine how much of the 1 an HOPD and that were attributed to an coinsurance payment amount would percent withhold a participant would HOPD would be used to calculate the have been under the FFS payment receive back. implied RVU shares, or the proportional system. We propose the incorrect payment weights of each of the three components We believe that maintaining the 20 withhold, the quality withhold, and the (Work, PE, and MP) that make up the percent coinsurance payment will help patient experience withhold be value of the RO Model-specific RVUs. preserve the integrity of the Model test included in the RO Model’s pricing Existing radiation oncology HCPCS and the goals guiding its policies. methodology. codes that are included in the bundled Adopting an alternative coinsurance policy that would maintain the h. Proposal To Adjust for Geography RO Model codes but paid only through the OPPS would not be included in the coinsurance that would apply in the Geographic adjustments are standard calculation. The RVU shares would be absence in the Model, where volume Medicare adjustments that occur in the calculated as the volume-weighted and modality type would dictate claims system. Even though the Model Work, PE, and MP shares of each coinsurance amounts, would change the would establish a common payment included existing HCPCS code’s total overall payment that RO participants amount for the same RT services RVUs in the PFS. The PCs and TCs for would receive. This would skew Model regardless of where they are furnished, the episodes under the Model would results as it would preserve the payment would still be processed have different RO Model-specific RVU incentive to use more fractions and through the current claims systems, shares, but these shares would not vary certain modality types so that a higher with adjustments as discussed in by cancer type. Table 4 provides the payment amount could be achieved. section III.C.7, for OPPS and PFS. proposed relative weight of each for the We note that, depending on the Geographic adjustments would be PCs and TCs of the RO Model-specific choice of modality and number of calculated within those shared systems RVUs share. fractions administered by the RO after CMS submits RO Model payment participant during the course of files to the Medicare Administrative TABLE 4—RVU SHARES treatment, the coinsurance payment Contractors that contain RO participant amount of the bundled rate may specific calculations of payment from Professional Technical occasionally be higher than what a steps (a) through (g). We would adjust component component beneficiary or secondary insurer would the trended national base rates that have Work PE MP Work PE MP otherwise pay under Medicare FFS. been adjusted for each RO participant’s However, because the PC and TC would case mix, historical experience and after 0.66 0.30 0.04 0.00 0.99 0.01 be subject to withholds and discounts which the discount rate and withholds described in the previous section, we have been applied, for local cost and We would include these RO Model- believe that, on average, the total wage indices based on where RT specific RVUs in the same process that coinsurance paid by RO beneficiaries services are furnished, pursuant to calculates geographically adjusted would be lower than what they would existing geographic adjustment payment amounts for other HCPCS have paid under Medicare FFS for all of processes in the OPPS and PFS. codes under the PFS with Work, PE, and the services included in an episode. In OPPS automatically applies a wage MP and their respective RVU value other words, the proposed withhold and index adjustment based on the current applied to each RO Model HCPCS code. discount factors would, on average, be year post-reclassification hospital wage We propose to apply the OPPS Pricer expected to reduce the total amount RO index to 60 percent (the labor-related as is automatically applied under OPPS beneficiaries or secondary insurers share) of the OPPS payment rate. No outside of the Model. We propose to use would owe RO participants. In addition, additional changes to the OPPS Pricer RO Model-specific RVU shares to apply because episode payment amounts are needed to ensure geographic PFS RVU components (Work, PE, and under the RO Model would include adjustment. MP) to the new RO Model payment payments for RT services that would The PFS geographic adjustment has amounts in the same way they are used likely be provided over multiple visits, three components that are applied to adjust payments for PFS services. the beneficiary coinsurance payment for separately to the three RVU components each of the episode’s payment amounts i. Proposal To Apply Coinsurance that underlie the PFS—Work, PE and would likewise be higher than it would MP. To calculate a locality-adjusted We propose to calculate the otherwise be for a single RT service payment rate for the RO participants coinsurance amount for a RO visit. For RO beneficiaries who do not paid under PFS, we would create a set beneficiary after applying, as have a secondary insurer, we would of RO Model-specific RVUs using the appropriate, the proposed case mix and encourage RO participants to collect national (unadjusted) payment rates for historical experience adjustments, coinsurance for services furnished each HCPCS code of the included RT withholds, discount factors, and under the RO Model in multiple services for each cancer type included geographic adjustments to the trended installments via a payment plan in the RO Model. First, the trended national base rates for the cancer type (provided the RO participants would national base rates for the PC and TC billed by the RO participant for the RO inform patients of the installment plan’s would be divided by the PFS conversion beneficiary’s treatment. Under current availability only during the course of factor (CF) for the upcoming year to policy, Medicare FFS beneficiaries are the actual billing process). create a RO Model-specific RVU value generally required to pay 20 percent of In addition, we would continue to for the PC and TC payment amounts. the allowed charge for services apply the limit on beneficiary liability Next, since the PFS geographic furnished by HOPDs and physicians (for for copayment for a procedure (as adjustments are applied separately to example, those services paid for under described in in section 1833(t)(8)(C)(i) of the three RVU components (Work, PE, the OPPS and PFS, respectively). This the Act) to the trended national base and MP), these RO Model-specific RVUs policy would remain the same under the rates that concern the TC after the case

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mix and historical experience experience adjustments, withholds, of RT professional services to RO adjustments, discount factor, applicable discount factors, and geographic beneficiary for an episode of lung withholds, and geographic adjustment adjustments have been applied. cancer. The participant-specific have been applied. j. Example of Participant-Specific professional episode payment in this We invite public comment on our Professional Episode Payment and example does not include any withhold proposal to apply the standard Participant-Specific Technical Episode amount that the RO participant would coinsurance of 20 percent to the trended Payment for an Episode Involving Lung be eligible to receive back or repayment national base rates for the cancer type Cancer in PY1 if more money is needed beyond the withhold amount from the RO billed by the RO participant for the RO Table 5 details the participant-specific participant. beneficiary’s treatment after the professional episode payment paid by proposed case mix and historical CMS to a single TIN for the furnishing BILLING CODE P

Table 6 details the participant-specific furnishing of RT technical services to a conventions of steps (n)–(r) in Table 6 technical episode payment paid by CMS RO beneficiary for an episode of lung may vary under the OPPS. to a single TIN or single CCN for the cancer. The sequence and naming

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BILLING CODE C incomplete episodes and reduces the episode payments for RT services We invite public comment on our likelihood that the limit on beneficiary covered under the RO Model using the proposed pricing methodology. liability for copayment for a procedure existing Medicare payment systems by 7. Proposed Professional and Technical provided in a HOPD (as described in making RO Model-specific revisions to Billing and Payment section 1833(t)(8)(C)(i) of the Act) is the current Medicare FFS claims met. processing systems. We would make Similar to how many procedure codes have professional and technical Accordingly, we propose to pay for changes to the current Medicare components as identified in the CMS complete episodes in two installments: payment systems using the standard National Physician Fee Schedule One tied to when the episode begins, Medicare Fee for Service operations Relative Value File, all episodes would and another tied to when the episode policy related Change Requests (CRs). be split into two components, the PC ends. Under this proposed policy a Our proposed design for testing a and the TC, to allow for use of current Professional participant would receive prospective episode payment model claims systems for PFS and OPPS to be two installment payments for furnishing (that is, the RO Model) for RT services used to adjudicate RO Model claims. We the PC of an episode, a Technical requires making prospective episode believe that the best design for a participant would receive two payments for all RT services included in prospective episode payment system for installment payments for furnishing the an episode, as proposed in section RT services is to pay the full TC of an episode, and a Dual participant III.C.5.c, instead of using Medicare FFS participant-specific professional and would receive two installment payments for services provided during technical episode payment amounts in payments for furnishing the PC and TC an episode. Local coverage two installments. We believe that two of an episode. determinations (LCDs), which provide payments reduce the amount of money To reduce burden on RO participants, information about the reasonable and that may need to be recouped due to we propose to make the prospective necessary conditions of coverage

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allowed, would still apply to all RT for the TC would be made through paid but before the TC of the episode services provided in an episode. either the OPPS or PFS to the Technical has been initiated (also referred to as an Professional participants and Dual participant or Dual participant that incomplete episode), during the annual participants would be required to bill a furnished TC of the episode. The two reconciliation process CMS would new model-specific HCPCS code and a payments for the TC of the episode subtract the first episode payment paid modifier indicating the start of an would cover the provision of to the Professional participant or Dual episode (SOE modifier) for the PC once equipment, supplies, personnel, and participant from the FFS payments the treatment planning service is costs related to the radiation treatment owed to that RO participant for services furnished. We would develop a new during the episode. furnished to the beneficiary and listed HCPCS code (and modifiers, as The TC of the episode would begin on on the no-pay claims before the appropriate) for the PC of each of the or after the date that the PC of the transition occurred. included cancer types under the Model. episode is initiated and would last until In the event that traditional Medicare The two payments for the PC of the the PC of the episode concludes. stops being the primary payer after the episode would cover all RT services Accordingly, the portion of the episode SOE claims for the PC and TC were provided by the physician during the during which the TC is furnished may paid, any submitted EOE claims would episode. Payment for the PC would be be up to 90 days long, but could be be returned and the RO participant(s) made through the PFS and would only shorter due to the time between when would only receive the first episode be paid to physicians (as identified by the treatment planning service is payment, regardless of whether their respective TINs). furnished to the RO beneficiary and treatment was completed. If a Under our proposed billing policy, a when RT treatment begins. This is beneficiary dies or enters hospice after Professional participant or Dual because the treatment planning service both PC and TC of the episode have participant that furnishes the PC of the and the actual RT treatment do not been initiated, the RO participant(s) episode must bill one of the new RO always occur on the same day. may bill EOE claims and be paid the Model-specific HCPCS codes and SOE RO participants would be required to second half of the episode payment modifier. This would indicate within submit encounter data (no-pay) claims amounts regardless of whether the claims systems that an episode has that include all RT services identified treatment was completed. This is started. Upon submission of a claim on the RO Model Bundled HCPCS list because death and hospice are included with a RO Model-specific HCPCS codes (Table 2) as services are furnished and in the case mix adjuster. and SOE modifier, we would pay the would otherwise be billed under the first half of the payment for the PC of Medicare FFS systems. We will monitor There may be instances where new the episode to the Professional trends in utilization of RT services providers and suppliers begin participant or Dual participant. A during the Model. These claims will not furnishing RT services in a CBSA Professional participant or Dual be paid because the bundled payments selected to participate in the RO Model. participant must bill the same RO cover RT services provided during the These new providers and suppliers Model-specific HCPCS code that episode. The encounter data would be would be RO participants and would initiated the episode with a modifier used for evaluation and model have to be identified as such in the indicating the end of an episode (EOE) monitoring, specifically trending claims systems. When a claim is after the end of the 90-day episode. This utilization of RT services, and other submitted with a RO Model-specific would indicate that the episode has CMS research. HCPCS code for a site of service that is ended. Upon submission of a claim with If a RO participant provides clinically located within one of the randomly a RO Model-specific HCPCS codes and appropriate RT services during the 28 selected CBSAs as identified by the EOE modifier we would pay the second days after an episode ends, then the RO service location’s ZIP Code, but the CCN half of the payment for the PC of the participant must bill Medicare FFS for or TIN is not yet identified as a RO episode to the Professional participant those RT services. A new episode may participant in the claims systems, the or Dual participant. not be initiated during the 28 days after claim would be paid using the rate Under our proposed billing policy, a an episode ends. As we explain in assigned to that RO Model-specific Technical participant or a Dual section III.C.5.b.(3). of this proposed HCPCS code without the adjustments. participant that furnishes the TC of an rule, we refer to this 28 day period as Once we are aware of these new episode must bill a new model-specific the ‘‘clean period.’’ providers and suppliers, they will be HCPCS code with a SOE modifier. We In the event that a RO beneficiary identified in the claims system and will would pay the first half of the payment changes RT provider or RT supplier be paid using Model-specific HCPCS for the TC of the episode when a after the SOE claim has been paid, CMS code with or without the adjustments, Technical participant or Dual would subtract the first episode depending on whether the TIN or CCN participant furnishes the TC of the payment paid to the RO participant new to the Model is a result of a merger, episode and bills for it using model- from the FFS payments owed to the RO acquisition, or other new clinical or specific HCPCS code with a SOE participant for services furnished to the business relationship and there is modifier. We would pay the second half beneficiary before the transition sufficient data to calculate those of the payment for the TC of the episode occurred and listed on the no-pay adjustments as described in the pricing after the end of the episode. The claims. This would occur during the methodology section III.C.6. of this Technical participant or Dual annual reconciliation process described proposed rule. participant must bill the same RO in section III.C.11. of this proposed rule. Lists of RO Model-specific HCPCS Model-specific HCPCS code with an The subsequent provider or supplier codes would be made available on the EOE modifier that initiated the episode. (whether or not they are a RO RO Model website prior to the model This would indicate that the episode participant) would bill FFS for performance period. In addition, we has ended. furnished RT services. expect to provide RO participants with Similar to the way PCs are billed, we Similarly, in the event that a additional instructions for billing the would develop a new HCPCS codes beneficiary dies, enters hospice, or RO Model-specific HCPCS codes (and any modifiers) for the TC of each chooses to defer treatment after the PC through the Medicare Learning Network of the included cancer types. Payment has been initiated and the SOE claim (MLN Matters) publications, model-

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specific webinars, and the RO Model • Oncology: Medical and Radiation— requirement does not apply to the RO website. Plan of Care for Pain—NQF 41 #0383; Model. However, if a relevant outcome CMS Quality ID #144 measure becomes available, we would 8. Quality • Preventive Care and Screening: consider it for inclusion in the RO The quality measures we propose in Screening for Depression and Follow- Model’s measure set if deemed appropriate. this proposed rule, along with the Up Plan—NQF #0418; CMS Quality ID proposed clinical data elements in #134 We believe our proposed use of • quality measures as described in our section III.C.8.e, would be scored Advance Care Plan—NQF #0326; CMS proposed AQS scoring methodology in according to the methodology proposed Quality ID #047 • section III.C.8.f. of this proposed rule in section III.C.8.f to calculate the Treatment Summary Communication—Radiation Oncology would meet the quality measure and Aggregate Quality Score (AQS). The We are proposing to adopt these cost/utilization requirement for a MIPS AQS would be applied to the quality APM under section 42 CFR withhold described in section quality measures for the RO Model for two reasons. First, the Model is 414.1370(b)(3). III.C.6.g.(2). of this proposed rule to In selecting the proposed measure set calculate the quality reconciliation designed to preserve or enhance quality of care, and quality measures would for the RO Model, we sought to payment amount due to a Professional prioritize quality measures that have participant or Dual participant as allow us to quantify the impact of the Model on quality of care, RT services been endorsed by a consensus-based specified in section III.C.11. of this and processes, outcomes, patient entity or have a strong evidence-based proposed rule. Results from selected satisfaction, and organizational focus and have been tested for reliability patient experience measures based on and validity. We focused on measures ® structures and systems. Second, as the CAHPS Cancer Care Survey would discussed in section III.C.9 of this that would provide insight and be incorporated into the AQS for proposed rule, we intend for the RO understanding into the Model’s Professional participants and Dual Model to qualify as an Advanced APM, effectiveness and that would facilitate participants starting in PY3. For and also meet the criteria to be a MIPS achievement of the Model’s care quality Technical participants, results from APM. As stated previously, we believe goals. We also sought to include quality these patient experience measures the proposed quality measures would measures that align with existing quality would be incorporated into the AQS satisfy the quality measure-related measures already in use in other CMS starting in PY3 and applied to the requirements for both an Advanced quality reporting programs such as patient experience withhold described APM and a MIPS APM. We believe that MIPS so that Professional participants in section III.C.6.g.(3). of this proposed the following proposed measures meet and Dual participants would be familiar rule. the requirements of 42 CFR with the measures used in the Model. 414.1415(b)(2): (1) Oncology: Medical Lastly, we considered cross-cutting a. Proposed Measure Selection and Radiation—Plan of Care for Pain; (2) measures that would allow comparisons of quality across episode payment We propose to adopt the following set Preventive Care and Screening: Screening for Depression and Follow- models and other CMS model tests. of quality measures for the RO Model in While we believe the proposed order to assess the quality of care Up Plan; and (3) Advance Care Plan. These measures are already adopted in measure set would provide the Model provided during episodes. We would MIPS, and we believe the other with sufficient measures for the model begin requiring annual quality measure proposed measure is evidence based, performance period to monitor quality data submission by Professional reliable, and valid. We note, however, improvement in the radiation oncology participants and Dual participants in that we have not proposed an outcome sector, and to calculate scoring on March of 2021 for episodes starting and measure for the RO Model. Under 42 quality performance, we intend to adjust ending inPY1, Quality measures will CFR 414.1415(b)(3), the quality the measure set in future PYs by adding continue requiring annual data measures upon which an Advanced new measures or removing measures if submissions thereafter through the APM bases payment to participants for we determine those adjustments to be remainder of the model performance covered professional services under the appropriate at the time. Prior to adding period as described in section III.C.8.c. terms of the APM must include at least or removing measures we would use of this proposed rule These quality one additional measure that is an notice and comment rulemaking. measures would be used to determine a outcome measure unless CMS Table 7 includes the four proposed RO participant’s AQS, proposed in determines that there are no available or RO Model quality measures and section III.C.8.f. of this proposed rule, applicable outcome measures included CAHPS® Cancer Care Survey, the level and subsequent quality reconciliation in the MIPS final quality measures list at which measures would be reported, amount, described in section III.C.11. of for the Advanced APM’s first QP and the measures’ status as pay-for- this proposed rule. Based on the Performance Period. Because we have reporting or pay-for-performance, as considerations set forth in this rule, we determined there are currently no described in section III.C.8.b. of this propose the following measures for the outcome measures available or proposed rule. The table also includes RO Model beginning in PY1 and applicable for the RO Model, this the RO Model clinical data elements continuing thereafter: collection, proposed in section III.C.8.e. 41 National Quality Forum. of this proposed rule.

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b. Proposed RO Model Measures and exists.44 The fourth measure in the RO performance measurement with a focus CAHPS® Cancer Care Survey for Model (Treatment Summary on clinical care and patient experience. Radiation Therapy Communication) will be applied as pay- (1) Proposed Oncology: Medical and for-reporting until such time that a In this section, we describe more fully Radiation—Plan of Care for Pain (NQF benchmark can be developed, which is #0383; CMS Quality ID #144) the proposed quality measures that we expected to be PY3, as discussed in propose to use in the RO Model for section III.C.8.f.(1). of this proposed We propose to adopt the Oncology: purposes of designing a model that rule. All four measures are clinically Medical and Radiation—Plan of Care for could qualify as an Advanced APM and appropriate for RT. We selected these Pain measure in the RO Model. The a MIPS APM, and for measuring quality measures based on clinical Oncology: Medical and Radiation—Plan of care. We describe each measure and of Care for Pain is a process measure our reasons for its proposed selection in appropriateness to cover RT spanning the 90-day episode period. These that assesses whether a plan of care for this proposed rule. We also describe the pain has been documented for patients CAHPS® Cancer Care Survey for measures ensure coverage across the full range of cancer types included in the with cancer who report having pain. Radiation Therapy and our proposal to This measure assesses the ‘‘[p]ercentage administer the survey as part of the RO Model and provide us the ability to accurately measure changes or of patients, regardless of age, with a Model. diagnosis of cancer who are currently improvements related to the Model’s We selected these proposed quality receiving chemotherapy or RT that have aims. In addition, we are also proposing measures for the RO Model after moderate or severe pain for which there the CAHPS® Cancer Care Survey to conducting a comprehensive is a documented plan of care to address environmental scan that included collect information that we believe is pain in the first two visits.’’ 46 As stated stakeholder and clinician input and appropriate and specific to a patient’s in the FY 2014 IPPS/LTCH PPS final compiling a measure inventory. Three of experience during an RT episode. We rule (78 FR 50843), pain is the most ® the four measures that we are proposing believe these measures and the CAHPS common symptom in cancer, occurring 45 are currently NQF-endorsed 42 process Cancer Care Survey would allow the in approximately one quarter of patients measures approved for MIPS.43 The RO Model to develop an aggregate with newly diagnosed malignancies, three NQF-endorsed measures approved quality score (AQS) in our pay-for- one third of patients undergoing for MIPS (Plan of Care for Pain; performance methodology (described in treatment, and three quarters of patients Screening for Depression and Follow- section III.C.8.f.) that incorporates with advanced disease.47 Proper pain Up Plan; and Advance Care Plan) will be applied as pay-for-performance, 44 Baseline performance is based on the entirety 46 Oncology: Medical and Radiation—Plan of Care given that baseline performance data of data submitted to meet MIPS data reporting for Pain. American Society of Clinical Oncology. In requirements for these measures and are not Review for Maintenance of Endorsement by the specific to radiation oncology performance. National Quality Forum (NQF #0383). Last 42 NQF endorsement summaries: http:// 45 As discussed in section III.C.8.b(5) and III.C.8.f, Updated: June 26, 2018. www.qualityforum.org/News_And_Resources/ the CAHPS® Cancer Care Survey would be 47 Swarm RA, Abernethy AP, Anghelescu DL, et Endorsement_Summaries/Endorsement_ administered beginning in April 1, 2020, and we al. Adult Cancer Pain: Clinical Practice Guidelines Summaries.aspx. would seek to include measures in the aggregate in Oncology. Journal of the National 43 See the CY 2018 QPP final rule (82 FR 53568). quality score beginning inPY3. Continued

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management is critical to achieving pain submission portal and the measure measure has been used for payment control. This measure aims to improve specification. The current version of the determination within OCM (beginning attention to pain management and Plan of Care for Pain measure in 2016 as OCM–5) and MIPS requires a plan of care for cancer specification states the data would be (beginning in CY2018 as CMS #134) and patients who report having pain to reported for the performance year that is NQF endorsed. As long as the allow for individualized treatment. covers the date of encounter. The measure remains reliable and relevant to We believe this measure is measure numerator includes patient the RO Model’s goals, we would appropriate for inclusion in the RO visits that included a documented plan continue to include the measure in the Model because it is specific to a RT of care to address pain. The measure Model, regardless of use in other CMS episode of care. It considers the quality denominator includes all visits for programs. If we were to remove the of care of medical and radiation patients, regardless of age, with a measure, we would use notice and oncology and is NQF endorsed. The RO diagnosis of cancer currently receiving comment in rulemaking. This measure Model would adopt the measure chemotherapy or radiation therapy who would be a pay-for-performance according to the most recent version of report having pain. Any exclusions can measure beginning in PY1 and scored in the specifications, which is under be found in the detailed measure accordance with our proposed review at NQF in Fall 2019. The current specification linked in this section of methodology in section III.C.8.f. measure version is being used for this proposed rule. As discussed further in section payment determination within the PPS- For the RO Model, we propose to use III.C.8.c, we would require Professional Exempt Cancer Hospital Quality the registry specifications for this participants and Dual participants to Reporting (PCHQR) Program (beginning measure. Detailed measure report quality measure data to the RO in FY2016 as PCH–15), the Oncology specifications may be found at: https:// Model-specific data collection system in Care Model (OCM) (beginning in 2016 qpp.cms.gov/docs/QPP_quality_ the manner consistent with that as a component of OCM–4), and the measure_specifications/Claims-Registry- submission portal and the measure Merit-based Incentive Payment System Measures/2018_Measure_144_ specification. The current version of the (MIPS) (beginning in CY2017 as CMS Registry.pdf. Preventive Care and Screening: Screening for Depression and Follow- #144). As long as the measure remains (2) Proposed Preventive Care and Up Plan measure specification states the reliable and relevant to the RO Model’s Screening: Screening for Depression and data would be reported for the goals, we would continue to include the Follow-Up Plan (NQF #0418; CMS performance year that covers the date of measure in the Model regardless of Quality ID #134) whether or not the measure is used in encounter. The measure numerator other CMS programs. If we believed that We propose to adopt the Preventive includes patients screened for it was necessary to remove the measure Care and Screening: Screening for depression on the date of the encounter from the RO Model, then we would Depression and Follow-Up Plan using an age-appropriate standardized propose to do so through notice and measure in the RO Model. The tool and, if the screening is positive, a comment rulemaking. Preventive Care and Screening: follow-up plan is documented on the This measure is currently undergoing Screening for Depression and Follow- date of the positive screen. The measure triennial review for NQF endorsement, Up Plan measure is a process measure denominator includes all patients aged and while we expect changes to the that assesses the ‘‘[p]ercentage of 12 years and older before the beginning measure specifications, we do not patients screened for clinical depression of the measurement period with at least believe these changes would change the with an age-appropriate, standardized one eligible encounter during the fundamental basis of the measure, nor tool and who have had a follow-up care measurement period. Any exclusions do we believe they would impact the plan documented in the medical can be found in the detailed measure 48 measure’s appropriateness for inclusion record.’’ We believe this clinical topic specification linked in this section in in the RO Model. NQF endorsement is is appropriate for a RT episode of care this proposed rule. a factor in our decision to propose the even though it is not specific to RT. For the RO Model, we propose to use Medical and Radiation—Plan of Care for While this measure is drafted for the registry specifications for this Pain measure, but it is not the only consideration of general mental health, measure. Detailed measure factor, so if the measure were to lose its it can also be applied to RT. Because specifications may be found at: https:// NQF endorsement, we may choose to some of the side effects of RT have been qpp.cms.gov/docs/QPP_quality_ identified as having a detrimental effect retain it so long as we believe it measure_specifications/Claims-Registry- on a patient’s quality of life and could continues to support CMS and HHS Measures/2018_Measure_134_ potentially impact the patient beyond policy goals. Therefore, we propose to Registry.pdf. physical discomfort or pain, we believe adopt the Plan of Care for Pain measure inclusion of this measure is desirable to 51 with the associated specifications Li, M., Kennedy, E.B., Byrne, N., Ge´rin-Lajoie, screen and treat the potential mental available beginning in PY1. This C., Katz, M.R., Keshavarz, H., . . . Green, E. (2016). health effects of RT. 49 50 51 52 53 54 This Management of Depression in Patients With Cancer: measure will be a pay-for-performance A Clinical Practice Guideline. Journal of Oncology Practice, 12(8), 747–756. doi:10.1200/ measure and scored in accordance with 48 Preventive Care and Screening: Screening for jop.2016.011072. our proposed methodology in section Depression and Follow-Up Plan. Centers for 52 III.C.8.f. Medicare & Medicaid Services. Endorsed by the Pinquart, M., & Duberstein, P.R. (2010). National Quality Forum (NQF #0418). Last Depression and cancer mortality: A meta-analysis. As discussed further in section Psychological Medicine, 40(11), 1797–1810. III.C.8.c, we would require Professional Updated: Jun 28, 2017. 49 Siu AL, and the US Preventive Services Task doi:10.1017/s0033291709992285. participants and Dual participants to Force USPSTF. Screening for Depression in Adults: 53 Massie, M.J. (2004). Prevalence of Depression report quality measure data to the RO US Preventive Services Task Force in Patients With Cancer. Journal of the National Model-specific data collection system in Recommendation Statement. JAMA. Cancer Institute Monographs, 2004(32), 57–71. doi:10.1093/jncimonographs/lgh014. the manner consistent with that 2016;315(4):380–387. doi:10.1001/jama.2015.18392. 50 Meijer, A., Roseman, M., Milette, K., Coyne, 54 Linden, W., Vodermaier, A., Mackenzie, R., & J.C., Stefanek, M.E., Ziegelstein, R.C., . . . Thombs, Greig, D. (2012). Anxiety and depression after Comprehensive Cancer Network: JNCCN. B.D. (2011). Depression screening and patient cancer diagnosis: Prevalence rates by cancer type, 2013;11(8):992–1022. Available at: https:// outcomes in cancer: a systematic review. PloS one, gender, and age. Journal of Affective Disorders, www.ncbi.nlm.nih.gov/pmc/articles/PMC5915297/. 6(11), e27181. doi:10.1371/journal.pone.0027181. 141(2–3), 343–351. doi:10.1016/j.jad.2012.03.025.

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(3) Proposed Advance Care Plan (NQF For the RO Model, we propose to use communicated to the physician(s) #0326; CMS Quality ID #047) the registry specifications for this providing continuing care and to the measure. Detailed measure patient within one month of completing We propose to adopt the Advance specifications may be found at: https:// treatment. The measure denominator Care Plan measure in the RO Model. qpp.cms.gov/docs/QPP_quality_ includes all patients, regardless of age, The Advance Care Plan measure is a measure_specifications/Claims-Registry- with a diagnosis of cancer who have process measure that describes Measures/2018_Measure_047_ undergone brachytherapy or external percentage of patients aged 65 years and Registry.pdf. beam radiation therapy. Any exclusions older that have an advance care plan or can be found in the detailed measure surrogate decision maker documented (4) Proposed Treatment Summary Communication—Radiation Oncology specification linked in this section of in the medical record or documentation this proposed rule. in the medical record that an advance We propose to adopt the Treatment For the RO Model, we propose to use care plan was discussed but the patient Summary Communication—Radiation the registry specifications for this did not wish or was not able to name Oncology measure in the RO Model. measure. Detailed measure a surrogate decision maker or provide The Treatment Summary specifications may be found at: http:// an advance care plan. This is a cross- Communication measure is a process www.qualityforum.org/QPS/0381. cutting measure across all specialties measure that assesses the ‘‘[p]ercentage ® and a variety of settings, but we believe of patients, regardless of age, with a (5) Proposed CAHPS Cancer Care that it appropriate for the RO Model diagnosis of cancer that have undergone Survey for Radiation Therapy because we believe that it is essential brachytherapy or external beam RT who We propose to have a CMS-approved that a patient’s wishes regarding have a treatment summary report in the contractor administer the CAHPS® medical treatment are established as chart that was communicated to the Cancer Care Survey for Radiation much as possible prior to incapacity. physician(s) providing continuing care Therapy (‘‘CAHPS® Cancer Care This measure is NQF endorsed and and to the patient within one month of survey’’) beginning April 1, 2020 and 55 has been collected for OCM (beginning completing treatment.’’ We believe ending in 2025 to account for episodes in 2018 as OCM–24) and MIPS this measure is appropriate for inclusion that were completed in the last quarter ® (beginning in CY2018 as CMS #047), in the RO Model because it is specific of 2024. We are proposing the CAHPS making its data collection processes to a RT episode of care. This measure cancer care survey for inclusion in the reasonably well established. As long as assesses care coordination and Model as it is appropriate and specific the measure remains reliable and communication between providers to patient experience of care within a ® relevant to the RO Model’s goals, we during transitions of cancer care RT episode. Variations of the CAHPS would continue to include the measure treatment and recovery. While this survey are widely used measures of in the Model, regardless of use in other measure is not NQF endorsed, and has patient satisfaction and experience of CMS programs and initiatives. If we not been used in previous or current care and are responsive to the increasing believed it was necessary to remove the CMS quality reporting, it has been used shift toward incorporation of patient in the oncology field for quality measure from the Model, we would experience into quality measurement improvement efforts, making propose to do so through notice and and pay-for-performance programs. considerations regarding data collection ® comment rulemaking. This measure Variations of the CAHPS survey have reasonably well established. We propose would be a pay-for-performance been used within the PCHQR Program, to include the measure as we believe it measure beginning in PY1 and scored in Hospital OQR Program, MIPS, OCM, to be valid and relevant to the RO accordance with our proposed and others, making considerations Model’s goals. This measure will be the methodology in section III.C.8.f. regarding data collection reasonably one pay-for reporting measure included well established. As discussed further in section in the calculation of the AQS until a In future rulemaking, we plan to III.C.8.c, we would require Professional benchmark is established that would propose a set of patient experience participants and Dual participants to enable it to be pay-for-performance, measures based on the CAHPS® Cancer report quality measure data the RO which is expected to be beginning in Care survey, which would be included Model-specific data collection system in PY3. in the AQS as pay-for-performance the manner consistent with that As discussed further in section measures beginning in PY 3. submission portal and the measure III.C.8.c, we would require Professional The CAHPS® Cancer Care survey specification. The current version of the participants and Dual participants to proposed for inclusion in the RO Model Advance Care Plan measure report quality measure data to the RO may be found at https://www.ahrq.gov/ specification states the data would be Model-specific data collection system in cahps/surveys-guidance/cancer/ reported for the performance year that the manner consistent with that index.html. covers the date of documentation in the submission portal and the measure We invite public comment on our medical record. The measure numerator specification. The current version of the proposal to administer the CAHPS® includes patients who have an advance Treatment Summary Communication Cancer Care Survey for Radiation care plan or surrogate decision maker measure specification states the data Therapy for purposes of testing the RO documented in the medical record or would be reported for the performance Model. documentation in the medical record year that covers the date of the that an advance care plan was discussed treatment summary report in the chart. c. Proposed Form, Manner, and Timing but patient did not wish or was not able The measure numerator includes for Quality Measure Data Reporting to name a surrogate decision maker or patients who have a treatment summary We propose the following data provide an advance care plan. The report in the chart that was collection processes for the four measure denominator includes all proposed quality measures described in patients aged 65 years and older. Any 55 Oncology: Treatment Summary section III.C.8.b.(1) through (4). of this exclusions can be found in the detailed Communication—Radiation Oncology. American Society for Radiation Oncology. Endorsement proposed rule beginning in PY1. measure specification linked in this removed by the National Quality Forum (NQF First, we propose to require section of this proposed rule. #0381). Last Updated: Mar 22, 2018. Professional participants and Dual

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participants to report aggregated quality to use these mechanisms for data would perform education and outreach measure data, instead of beneficiary- collection and where to submit the data so that RO participants would have the level quality measure data. These data prior to the first data submission period. opportunity to become more familiar will be used to calculate the We propose that Professional with the CAHPS® Cancer Care survey participants’ quality performance as participants and Dual participants process and ask any questions. discussed in section III.C.8.f.(1). of this would be required to submit quality d. Proposed Maintenance of Technical proposed rule and subsequent quality measure data annually by March 31 Specifications for Quality Measures reconciliation payments on an annual following the end of the previous PY to basis. the RO Model measure submission As part of its regular maintenance Second, we propose to require that portal. In developing the March 31 process for NQF-endorsed performance data be reported for all applicable deadline, we considered the quality measures, the NQF requires measure patients (for example, not just Medicare measure reporting deadlines of other stewards to submit annual measure beneficiaries or beneficiaries with CMS programs in conjunction with the maintenance updates and undergo radiation episodes under the Model) needs of the Model. For PY1, maintenance of endorsement review based on the numerator and participants would submit quality every 3 years. In the measure denominator specifications for each measure data for the time period noted maintenance process, the measure measure. We believe collecting data for in the measure specification. Thus, if a steward (owner/developer) is all patients who meet the denominator measure is calculated on an annual CY responsible for updating and specifications for each measure from a basis, participants would not adjust the maintaining the currency and relevance Professional participant or Dual reporting period to reflect the model of the measure and would confirm participant, and not just Medicare time period. We anticipate this existing or minor specification changes beneficiaries, is appropriate because it is adherence to the measure specifications with NQF on an annual basis. NQF consistent with the applicable measure used in MIPS would reduce measure solicits information from measure specifications, and any segmentation to reporting burden for RO participants. In stewards for annual reviews, and it solely the Medicare populations would the event that the model reviews measures for continued be inconsistent with the measure and implementation begins on April 1, 2020, endorsement in a specific three-year add substantial reporting burden to RO the calendar year submission would cycle. We note that NQF’s annual or participants. If a measure is already remain; this would allow RO triennial maintenance processes for reported in another program, then the participants to use their MIPS data endorsed measures may result in the measure data would be submitted to submission to meet the RO Model NQF requiring updates to the measures. that program’s reporting mechanism in requirements. We believe that any Additionally, the Model includes a form, manner, and at a time consistent segmentation to reflect only the RO measures that are not NQF-endorsed, with the other program’s requirements, Model time period in PY1 would be but we anticipate that they will and separately submitted to the RO inconsistent with the measure, and add similarly require non-substantive Model reporting portal in the form, substantial reporting burden to RO technical updates to remain current. manner and at the time consistent with participants. RO participants would e. Proposed Clinical Data Collection the RO Model requirements. submit data based on the individual Similar to the approach taken for the measure specifications as previously In addition to collecting quality Quality Payment Program,56 the RO discussed, unless otherwise announced measure data, we also propose under Model would not score measures for a by CMS. RO Model measure § 512.275(c) to collect clinical given Professional participant or Dual submissions would only satisfy the RO information on certain RO beneficiaries participant that does not have at least 20 Model requirements. Measures included in the Model from Professional applicable cases according to each submitted to any other CMS program participants and Dual participants that measure’s specifications. However, would need to continue to be made in furnish the PC of an episode for use in unlike the Quality Payment Program, if accordance with that program’s the RO Model’s pay-for-reporting measures do not have at least 20 requirements unless specifically noted. approach and for monitoring and applicable cases for the participant, we A schedule for data submission would compliance, which we discuss more would not require the measures to be be posted on the RO Model website: fully in sections III.C.8.f(1) and section reported. In this situation, an RO https://innovation.cms.gov/initiatives/ III.C.14, respectively. participant would enter ‘‘N/A- radiation-oncology-model/. On a pay-for-reporting basis, we insufficient cases’’ to note that an We would determine that Professional would require Professional participants insufficient number of cases exists for a participants and Dual participants and Dual participants to report basic given measure. successfully collected and submitted clinical information not available in We would provide Professional quality measure data if the data are claims or captured in the proposed participants and Dual participants with accepted in the RO Model portal by the quality measures, such as cancer stage, a mechanism to input quality measure reporting deadline of March 31 after the disease involvement, treatment intent, data. We would create a template for PY. Failure to submit quality measure and specific treatment plan information, Professional participants and Dual data within the previously discussed on RO beneficiaries treated for five participants to complete with the requirements would impact the RO types of cancer under the Model: (1) specified numerator and denominator participant’s AQS, as discussed in Prostate, (2) breast, (3) lung, (4) bone for each quality measure (and the section III.C.8.f. metastases, and (5) brain metastases. We number of cases excluded and exempt As discussed in section III.C.8.f, the would determine the specific data from the denominator, as per measure CAHPS® Cancer Care Survey for elements and reporting standards prior specifications exclusions and Radiation Therapy would be to the start of the Model and would exemptions allowances), provide a administered by a CMS contractor communicate them on the Model secure portal for data submission, and according to the guidelines set forth in website. provide education and outreach on how the survey administration guide, or In addition, we would provide otherwise specified by CMS. Prior to the education, outreach, and technical 56 42 CFR 414.1380(b)(1)(iii). first administration of the survey, we assistance. We believe this information

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is necessary to achieve the Model’s f. Proposal To Connect Performance on where such benchmarks are available goals of eliminating unnecessary or low- Quality Measures to Payment for the measures. The measures value care. We have also heard from (1) Proposed Calculation for the proposed as pay-for-performance for many stakeholders that they believe Aggregate Quality Score PY1 are selected from the list of MIPS incorporating clinical data is important quality measures: (1) Advance Care for developing accurate episode prices The AQS would be based on each Plan; (2) Preventive Care and Screening: Professional participant’s and Dual and understanding the details of care Screening for Depression and Follow- participant’s: (1) Performance on the set furnished during the episode that are Up Plan; (3) Oncology: Medical and of proposed evidenced-based quality not available in administrative data Radiation—Plan of Care for Pain. The measures in sections III.C.8.b(1), (2), and MIPS program awards up to ten points sources. We would use these data to (3) of this proposed rule compared to (including partial points) to participants support clinical monitoring and those measures’ quality performance for their performance rates on each evaluation of the RO Model. These data benchmarks; (2) reporting of data for the measure, and we would score RO may also be used to inform future proposed pay-for-reporting measures participants’ quality measure refinements to the Model. We may also (those without established performance performance similarly using MIPS use it to begin developing and testing benchmarks) in section III.C.8.b.(4) of benchmarks.58 For example, when a new radiation oncology-specific quality this proposed rule; and (3) reporting of Professional participant’s or Dual measures during the Model. clinical data elements on applicable RO participant’s measured performance To facilitate data collection, we plan beneficiaries proposed in section reaches the performance level specified to share the proposed clinical data III.C.8.e. of this proposed rule. for three points, we will award the elements and reporting standards with A measure’s quality performance participant three points. If applicable EHR vendors and the radiation oncology benchmark is the performance rate a MIPS benchmarks are not available, we specialty societies prior to the start of Professional participant or Dual would use other appropriate national the Model. Our goal would be to participant must achieve to earn quality benchmarks for the measure where structure data reporting standards so points for each measure proposed in appropriate. If a national benchmark is 57 that existing EHRs could be adjusted in section III.C.8.b. We believe a not available, we would calculate anticipation of this Model. Such Professional participant’s or Dual Model-specific benchmarks from the participant’s performance on these changes could allow for seamless data previous year’s historical performance quality measures, as well as successful extraction and reduce the additional data. If historical performance data are reporting of pay-for-reporting measures reporting burden on providers and may not available, then we would score the and clinical data elements, would measure as pay-for-reporting and would increase the quality of reporting. appropriately assess the quality of care provide credit to the Professional Providers may also opt to extract the provided by the Professional participant participant or Dual participant for necessary data elements manually. All or Dual participant. reporting the required data for the Professional participants and Dual Given the importance of clinical data measure. We intend to specify quality participants with RO beneficiaries for monitoring and evaluation of the RO measure data reporting requirements on treated for the five cancer types as Model, and the potential to use the data the RO Model website. Once previously listed would be required to for model refinements or quality benchmarks are established for the pay- report clinical data through a model- measure development, we propose to for-reporting measures, we would seek specific data collection system. We weight 50 percent of the AQS on the to use the benchmarks to score the would create a template for RO successful reporting of required clinical measures as pay-for-performance in participants to complete with the data and the other 50 percent of the subsequent years. specified clinical data elements, provide AQS on quality measure reporting and, As stated earlier in this rule, measures a secure portal for data submission, and where applicable, performance on those may be scored as pay-for-reporting provide education and outreach on how measures. Mathematically, this (instead of pay-for-performance). to use these mechanisms for data weighting would be expressed as Professional participants and Dual collection and where to submit the data follows: participants that report the measure in prior to the first data submission period. Aggregate Quality Score = Quality the form, time, and manner specified in We are also proposing to establish measures (0 to 50 points based on the measure specification would receive reporting standards. We propose that all weighted measure scores and ten points for the measure. Professional Professional participants and Dual reporting) + Clinical data (50 points participants and Dual participants that ≥ participants must submit clinical data when data is submitted for 95% of do not submit the measure in the form, time, and manner specified would information biannually, in July and applicable RO beneficiaries) receive zero points. As proposed in January, each PY for RO beneficiaries Quality measures would be scored as section III.C.8.b(4), the Treatment with the applicable cancer types that pay-for-performance or pay-for- reporting, depending on whether Summary Communication measure completed their 90-day episode within would be the only pay-for-reporting the previous six months. This would be established benchmarks exists, as proposed in section III.C.8. To score measure in PY1. in addition to the quality measure data The total points awarded for each as described in section III.C.8.c. measures as pay-for-performance, each Professional participant’s and Dual measure included in the AQS would We are specifically interested in participant’s performance rates on each also depend on the measure’s weight. feedback on the five cancer types where measure would be compared against We propose to weight all four of our we propose to collect clinical data, applicable MIPS program benchmarks, proposed quality measures (those which data elements should be captured deemed pay-for-performance as well as for the five cancer types, and potential 57 Benchmarks will be based on existing MIPS pay-for-reporting) equally and aggregate barriers to collecting data of this type. benchmarks, or other national benchmark where available. For measures without existing 58 The benchmarks are published annually at this We invite comments on our proposal benchmarks, we plan to develop our own CMS site: https://qpp.cms.gov/about/resource- to collect clinical data. benchmarks. library.

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them as half of the AQS. To accomplish have sufficient cases to report numerical Dual participants would either be that aggregation as half of the AQS, we data on three measures, meaning that it considered ‘‘successful’’ reporters and would award up to 10 points for each has a total of 30 possible points for the receive full credit for meeting our measure, then recalibrate Professional quality measures component of its AQS. requirements, or ‘‘not successful’’ participants’ or Dual participants’ If the Professional participant or Dual reporters and not receive credit. We measure scores to a denominator of 50 participant received scores on those propose to define successful reporting points. CAHPS® Cancer Care Survey for measures of nine points, four points, as the submission of clinical data for 95 Radiation Therapy results discussed in and seven points, it would have scored percent of RO beneficiaries with any of section III.C.8.b(5) would be added into 20 out of 30 possible points on the the five diagnoses listed in section the AQS beginning in PY3 and we quality measures component. That score III.C.8.e. If the Professional participant would propose the specific weights of is equivalent to 33.33 points after or Dual participant does not the selected measures from the CAHPS® recalibrating the denominator to 50 successfully report sufficient clinical survey in future rulemaking. We would points ((20/30) * 50 = 33.33). In data to meet the 95 percent threshold, also propose specific weights for instances where a Professional it would receive 0 out of 50 points for additional measures if and when the participant or Dual participant fails to the clinical data elements component of Model adopts additional measures in report quality reporting data for a the AQS. the future. measure, it would receive 0 out of 10 for To calculate the AQS, we propose to In cases where Professional that measure in the quality portion of sum each Professional participant’s or participants and Dual participants do the AQS, and the denominator would Dual participant’s points awarded for not have sufficient cases for a given remain at 40 points, which would then clinical data reporting with its measure—for example, if a measure be recalibrated to 50 points. For aggregated points awarded for quality requires 20 cases during the applicable example, if the same Professional measures to reach a value that would period for its calculation to be participant or Dual participant scored range between 0 and 100 points. As sufficiently reliable for performance 20 points out of 40 possible points, it discussed earlier in this rule, we would scoring purposes—that measure would would be equivalent to 25 points after recalibrate the points we award for be excluded from the AQS denominator recalibrating the denominator to 50 measures to a denominator of 50 points. calculation and the denominator would points ((20/40) * 50 = 25). We would then divide the AQS by 100 be recalibrated accordingly to reach a Our assessment of whether the points to express it as a percentage. denominator of 50 points. This Professional participant or Dual To illustrate the calculation of the recalibration is intended to ensure that participant has successfully reported AQS score two examples are included Professional participants and Dual clinical data would be based on whether in this rule. Table 8 details the AQS participants do not receive any benefit the participant has submitted the data in calculation for a Professional participant or penalty for having insufficient cases the time period identified and has or Dual participant that did not meet the on a given measure. furnished the data elements to us as minimum case requirements for one of For example, a Professional requested, which we discuss in section the pay-for-performance measures. participant or Dual participant might III.C.8.c. Professional participants and BILLING CODE P

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Table 9 details the AQS calculation participant that did not meet the data elements and the pay-for-reporting for a Professional participant or Dual reporting requirements for the clinical measure.

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BILLING CODE C amount of the quality withhold participant or Professional participant We believe that this method has the proposed in section III.C.6.g(2). that begins the RO Model after the start benefits of simplicity, normalization of of PY, but at least 30 days prior to the 9. The RO Model as an Advanced differences in reported measures final QP snapshot date of that PY, CMS Alternative Payment Model (Advanced between RO participants, and would create and provide the new Dual APM) and a Merit-Based Incentive appropriate incorporation of clinical participant or Professional participant Payment System APM (MIPS APM) data reporting. with an individual practitioner list. We invite public comment on the We anticipate that the RO Model In order to certify the list, an proposed calculation for the AQS would be both an Advanced APM and individual with the authority to legally methodology. a MIPS APM. For purposes of the bind the RO participant must certify the (2) Proposal To Apply the AQS to the Quality Payment Program, we propose accuracy, completeness, and Quality Withhold that the RO participant, specifically truthfulness of the list. The certified either a Dual participant or a individual practitioner list would We propose the following method to Professional participant, would be the include all individual practitioners who apply the AQS to the amount of the APM Entity. have reassigned their rights to receive quality withhold that could be earned We propose to establish an Medicare payment for the provision of back by a RO participant. We would ‘‘individual practitioner list’’ under the RT services to the TIN of the RO multiply the Professional participant’s RO Model, created by CMS and sent to participant. The individual with the or Dual participant’s AQS (as a Dual participants and Professional authority to bind the RO participant percentage) against the 2 percent quality participants to review, revise, certify, must agree to comply with the withhold amount. For example, if a and return to CMS so that CMS may requirements of the RO Model before Professional participant or Dual make QP determinations for the APM the RO participant certifies the list. We participant received an AQS of 88.3 out incentive payment amount and to note that we are not proposing that of a possible 100, then the Professional identify any MIPS eligible clinicians HOPDs that are Technical participants participant or Dual participant would who would be scored for MIPS based on be a part of this list process because as receive a 1.77 percent quality their participation in this MIPS APM. If HOPDs they are paid by OPPS, which is reconciliation payment amount (0.883 * finalized as proposed, the individual not subject to the Quality Payment 2.0 = 1.77%). If the total episode practitioner list would serve as the Program. We propose that RO payment amount for this RO participant Participation List as defined in the participants may make changes to the after applying the trend factor, regulation at section 414.1305 for the individual practitioner list that has been adjustments, and discount factor was Model. We propose to codify the term certified at the beginning of the $2,465.68,59 the example AQS of 88.3 ‘‘individual practitioner list’’ for performance year. In order to make would result in a quality reconciliation purposes of the RO Model in § 512.205 additions to the list, the RO participant payment amount of $43.64 ($2,465.68 * of our regulations. 60 must notify CMS within 15 days of an 1.77% = $43.64). The individuals included on the We would continue to weight individual practitioner becoming a individual practitioner list would Medicare-enrolled supplier that bills for measures equally in PY1 through PY5 include physician radiation oncologists unless we determine that the Model RT services under a billing number that are eligible clinicians participating assigned to the TIN of the RO needs to emphasize specific clinical in the RO Model with either a Dual transformation priorities or add new participant; the timely addition will be participant or a Professional participant effective on the date specified in the measures. Any updates to the scoring as described in section III.C.5.a of this methodology in future PYs would be notice furnished to CMS, but not earlier proposed rule. Eligible clinicians who than 15 days before the date of the proposed and finalized through notice- are identified on the participation list and-comment rulemaking. There may be notice. If the RO participant fails to for an Advanced APM during a QP submit timely notice of the addition, the some variation in the measures that we Performance Period may be determined score to calculate the AQS for addition is effective on the date of the to be Qualifying APM Participants (QPs) notice. The notice must be submitted in Professional participants and Dual as specified in our regulations at 42 CFR participants should they be unable to a form and manner specified by CMS. 414.1425, 414.1435, and 414.1440. In order to remove an individual report numerical data for certain Similarly, MIPS eligible clinicians who practitioner from the list, the RO measures due to sample size constraints are identified on the participation list participant must notify CMS within 15 or other reasons. However, we do not for the performance period of an APM days if an individual practitioner ceases anticipate that variation will create any Entity participating in a MIPS APM are to be a Medicare-enrolled supplier that methodological problems for the scored for MIPS using the APM scoring bills for RT services under a billing Model’s scoring purposes. standard as provided in our regulation number assigned to the TIN of the RO The AQS would be calculated at 42 CFR 414.1370. Only Professional participant; the timely removal will be approximately eight months after the participant physicians and Dual effective on the date specified in the end of each PY and applied to calculate participant physicians included on the notice furnished to CMS, but not earlier the quality withhold payment amount individual practitioner list would be than 15 days before the date of the for the relevant PY. Any portion of the considered eligible clinicians. notice. If the RO participant fails to quality withhold that is earned back We propose that prior to the start of submit timely notice of the removal, the would be distributed in an annual lump each PY, we would create and provide removal is effective on the date of the sum during the reconciliation process as each Dual participant and Professional notice. The notice must be submitted in described in section III.C.11. participant with an individual a form and manner specified by CMS. We invite public comments on our practitioner list. The Dual participants Further, we propose that the RO proposal to apply the AQS to the and Professional participants must participant must ensure that the review and certify the individual individuals included on the individual 59 This number refers to the result in line (j) in Table 5. participant list within 30 days of receipt practitioner list maintain compliance 60 This number is prior to the geographic of such list in a form and manner with the regulation at § 424.516, adjustment and sequestration being applied. specified by CMS. In the case of a Dual including notifying CMS of any

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reportable changes in status or following proposed quality measures APM Entity to owe payment(s) to CMS.’’ information. The certified individual when determining payment to The RO Model would meet this practitioner list would be used for Professional participants and Dual standard because CMS would not pay purposes related to QP determinations participants under the terms of the RO the RO participant more for RT services as specified in 42 CFR part 414 subpart Model, as discussed in detail in section than the episode payment amount. O. We further propose that if the Dual III.C.8.f.: (1) Oncology: Medical and The regulation at 42 CFR participant or Professional participant Radiation—Plan of Care for Pain; (2) 414.1415(c)(3) sets the standard for a does not verify and certify the Preventive Care and Screening: nominal amount of risk for Advanced individual practitioner list by the Screening for Depression and Follow- APMs other than Medical Home Models deadline specified by CMS, the Up Plan; and (3) Advance Care Plan; at either ‘‘eight percent of the average unverified list would be used for scoring and (4) Treatment Summary estimated total Medicare Parts A and B under MIPS using the APM scoring Communication—Radiation Oncology. revenues of participating APM Entities’’ standard. We propose to codify these Further, the quality measures we for QP Performance Periods in 2017 provisions relating to the individual propose to use for the RO Model are through 2024 or ‘‘three percent of the practitioner list at § 512.217. measures that are either finalized on the expected expenditures for which the In order to be an Advanced APM, the MIPS final list of measures, or APM Entity is responsible for under the RO Model must meet the criteria determined by CMS to be evidence APM’’ for all QP Performance Periods. specified in our regulation at 42 CFR based, reliable, and valid. Specifically, For the RO Model, we propose that 414.1415. First, in order to be an we believe that these measures would the APM Entities would be at risk for all Advanced APM, an APM must require meet the criteria under 42 CFR costs associated with RT services as participants to use certified EHR 414.1415(b). defined in section III.C.5.c beyond those technology (CEHRT). For QP In addition to the quality measure covered by the participant-specific Performance Periods beginning in 2019, requirements listed earlier, under 42 professional episode payment or the to meet this requirement, an Advanced CFR 414.1415(b)(3), the quality participant-specific technical episode APM must require at least 75 percent of measures upon which an Advanced payment, and therefore, would be at 100 eligible clinicians in the APM Entity or, APM bases payment must include at percent risk for all expenditures in for APMs in which hospitals are the least one outcome measure. This excess of the expected amount of APM Entities, each hospital, to use requirement does not apply if CMS expenditures, which are the CEHRT to document and communicate determines that there are no available or aforementioned episode payments. RO clinical care to their patients or other applicable outcome measures included participants would not receive any health care providers pursuant to 42 in the MIPS quality measures list for the additional payment or reconciliation CFR 414.1415(a)(1)(i). We propose that APM’s first QP Performance Period. from CMS (beyond the participant- during the model performance period, There currently are no such outcome specific professional episode payment the RO participant would be required to measures available or applicable for the or participant-specific technical episode annually certify its intent to use CEHRT RO Model’s first QP Performance payment) to account for any additional throughout such model year in a Period. If a relevant outcome measure medically necessary RT services manner sufficient to meet the becomes available, we would consider it furnished during the 90-day episode. requirements pursuant to 42 CFR for inclusion in the RO Model’s measure Effectively, this means that when actual 414.1415(a). Further, we propose that set if deemed appropriate. expenditures for which the APM Entity within 30 days of the start of PY1, the Third, the APM must require is responsible under the APM exceed RO participant would be required to participating APM Entities to bear expected expenditures, the RO certify its intent to use CEHRT financial risk for monetary losses of participant is responsible for 100 throughout such model year in a more than a nominal amount or, be a percent of those costs without any stop- manner sufficient to meet the Medical Home Model expanded under loss or cap on potential losses. This requirements pursuant to 42 CFR the Innovation Center’s authority, in would satisfy the requirement under 42 414.1415(a). Annual certification would accordance with section 1115A(c) of the CFR 414.1415(c)(3)(i)(B) because, for be required prior to the start of each Act. We expect that the RO Model example, if actual expenditures are 3 subsequent PY. would meet the generally applicable percent more, or 5 percent more, or 7 We solicit public comments on this financial risk standard in accordance percent more than the expected proposal. with 42 CFR 414.1415 because there is expenditures for which a RO participant Second, to be an Advanced APM, an no minimum (or maximum) financial is responsible under the model, the RO APM must include quality measure stop loss for RO participants, meaning participant is 100 percent liable for performance as a factor when RO participants would be at risk for all those additional 3 percent, 5 percent, or determining payment to participants for of the RT services beyond the episode 7 percent of costs without any limit to covered professional services under the payment amount. the total amount of losses they may terms of the APM as specified at 42 CFR The regulation at 42 CFR incur. 414.145(b)(1). Effective January 1, 2020, 414.1415(c)(1) requires that ‘‘to be an Additionally, we anticipate that the at least one of the quality measures Advanced APM, an APM must, based proposed RO Model would meet the upon which the APM bases payment on whether an APM Entity’s actual criteria to be a MIPS APM under the must meet at least one of the following expenditures for which the APM Entity Quality Payment Program starting in criteria: (a) Finalized on the MIPS final is responsible under the APM exceed PY1 if the implementation date is list of measures, as described in 42 CFR expected expenditures during a finalized as January 1, 2020 or PY2 if 414.1330; (b) endorsed by a consensus- specified QP Performance Period, do finalized as April 1, 2020. MIPS APMs, based entity; or (c) determined by CMS one or more of the following: (i) as defined in 42 CFR 414.1305, are to be evidenced-based, reliable, and Withhold payment for services to the APMs that meet the criteria specified valid. APM Entity or the APM Entity’s eligible under 42 CFR 414.1370(b). Pursuant to We discuss the RO Model’s proposed clinicians; (ii) Reduce payment rates to § 414.1370(a), MIPS eligible clinicians quality measure set in section III.C.8.b. the APM Entity or the APM Entity’s who are identified on a participation list We intend to use the results of the eligible clinicians; or (iii) Require the for the performance period of an APM

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Entity participating in a MIPS APM are subsection (d) hospitals that fail to meet schedule increase factor through the use scored under MIPS using the APM Hospital OQR Program requirements of a reporting ratio for those hospitals scoring standard. We propose to use the receive a two percentage point that fail to meet the Hospital OQR same individual practitioner list reduction to their outpatient department Program requirements for a year (83 FR developed as previously proposed, to (OPD) fee schedule increase factor. The 59108–59110). identify the relevant eligible clinicians fee schedule increase factor is applied In this proposed rule, we are for purposes of making QP annually to increase the OPPS proposing that, for purposes of APCs determinations and applying the APM conversion factor, which is then that contain RO Model-specific HCPCS scoring standard under the Quality multiplied by the relative payment codes, we would waive the requirement Payment Program. weight for a particular Ambulatory under section 1833(t)(17)(A)(i) of the We note that the following proposals Payment Classification (APC) to Act that the Secretary reduce the OPD would apply to any APM Incentive determine the payment amount for the fee schedule increase factor under Payments made for eligible clinicians APC. Not all OPPS items and services section 1833(t)(3)(C)(iv) of the Act or a who become QPs through participation are included in APCs for which the year by 2.0 percentage points for a in the RO Model: payment is determined using the subsection (d) hospital that does not • Our proposals regarding conversion factor. For this reason, we submit, to the Secretary in accordance monitoring, audits and record retention, only apply the 2 percent reduction to with paragraph (17), data required to be and remedial action, as described in APCs—identified by status indicators— submitted on measures selected under section II.F and III.C.14. Under our for which the payment is calculated by paragraph with respect to such a year. proposed monitoring policy, RO multiplying the relative payment weight RO Model-specific HCPCS codes would participants would be monitored for by the conversion factor. be mapped to RO Model-specific APCs for payment purposes under the OPPS. compliance with the RO Model Section 1833(t)(17) of the Act, which This waiver would apply only to the requirements. CMS may, based on the applies to subsection (d) hospitals (as APCs that include only the new HCPCS results of such monitoring, deny an defined in section 1886(d)(1)(B) of the codes that are created for the RO Model, eligible clinician who is participating in Act), states that hospitals that fail to rather than all APCs that package the RO Model QP status if the eligible report data required to be submitted on radiation HCPCS codes, and would only clinician or the eligible clinician’s APM measures selected by the Secretary, in a apply when a hospital does not meet entity (that is, the respective RO form and manner, and at a time, participant) is non-compliant with RO requirements under the Hospital OQR specified by the Secretary will incur a Program and would otherwise be subject Model requirements. 2.0 percentage point reduction to their • Our proposal in section III.C.10.c, to the 2.0 percentage point reduction. Outpatient Department (OPD) fee which explains that technical Only Technical participants using the schedule increase factor; that is, the component payments under the RO RO Model-specific HCPCS codes would annual payment update factor. The Model would not be included in the be paid under the Model; APCs not national unadjusted payment rates for aggregate payment amount for covered included in the Model, and thus not many services paid under the OPPS professional services that is used to using the RO Model-specific HCPCS equal the product of the OPPS calculate the amount of the APM codes, will continue to be paid under conversion factor and the scaled relative Incentive Payment. the OPPS and subject to the 2.0 We invite public comment on these payment weight for the APC to which percentage point reduction under the proposals. the service is assigned. The OPPS Hospital OQR Program when applicable. conversion factor, which is updated We believe this waiver is necessary in 10. Proposed Medicare Program Waivers annually by the OPD fee schedule order to equally evaluate participating We believe it would be necessary to increase factor, is used to calculate the HOPDs and freestanding radiation waive certain requirements of title XVIII OPPS payment rate for many services oncology centers on both cost and of the Act solely for purposes of under the OPPS. To reduce the OPD fee quality. carrying out the testing of the RO Model schedule increase factor for hospitals The RO Model is a test of a site- under section 1115A(b) of the Act. Each that fail to meet the Hospital OQR neutral pricing methodology, where of the waivers, which we discuss in Program reporting requirements, we payment rates are calculated in the same detail, would be necessary to ensure calculate two conversion factors—a full manner regardless of the setting (in this that the Model test’s design provides market basket conversion factor (that is, case, HOPDs and freestanding radiation additional flexibilities to RO the full conversion factor), and a therapy centers) and paid prospectively participants, including flexibilities reduced market basket conversion factor based on episodes of care. While around certain Medicare program (that is, the reduced conversion factor). payment amounts may vary across RO requirements. We then calculate a reduction ratio by participants, the calculation of how dividing the reduced conversion factor much each RO participant would be a. Proposed Waiver of Hospital by the full conversion factor. We refer paid for the PC and TC of the episode Outpatient Quality Reporting (OQR) to this reduction ratio as the ‘‘reporting is designed to be as similar as possible, Program Payment Adjustment ratio’’ to indicate that it applies to irrespective of whether the RO We believe that it is necessary for hospitals that fail to meet their reporting participant is an HOPD or a freestanding purposes of testing the RO Model to requirements. Applying this reporting radiation therapy center. Applying the waive the Hospital OQR Program ratio to the OPPS payment amounts Hospital OQR Program payment payment reduction authorized under results in reduced national unadjusted reduction would undermine our goal of section 1833(t)(17)(A) of the Act. Under payment rates that are mathematically site-neutral payments under the RO the Hospital OQR Program, subsection equivalent to the reduced national Model because it could affect HOPDs, (d) hospitals are required to submit data unadjusted payment rates that would but not freestanding radiation therapy on measures on the quality of care result if we multiplied the scaled OPPS centers, creating additional variables furnished by hospitals in outpatient relative payment weights by the reduced that could complicate a neutral settings. Further, Section conversion factor. Thus, our policy is to comparison. If the requirement to apply 1833(t)(17)(A)(i) of the Act states that apply the reduction of the OPD fee the Hospital OQR Program payment

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reduction were not waived, the MIPS eligible clinician during the RO participants that bill for services participant-specific technical episode applicable MIPS payment year. We under the professional RO Model- payments made with respect to services propose to waive the requirement to specific HCPCS codes would be subject furnished by RO participants in HOPDs apply the MIPS payment adjustment to payment adjustments under the that are billed under the technical RO factors under section 1848(q)(6)(E) of Model based on quality performance Model-specific HCPCS codes may be the Act and 42 CFR 414.1405(e) that through the quality withhold. The MIPS decreased due to the Hospital OQR may otherwise apply to payments made payment adjustment factors are Program payment reduction. for services furnished by a MIPS eligible determined in part based on a MIPS Meanwhile, the Hospital OQR Program clinician and billed under the eligible clinician’s performance on payment reduction would not apply to professional RO Model-specific HCPCS quality measures for a performance participating freestanding radiation codes (as identified in Table 2) because period. We believe subjecting a RO therapy centers, which are paid under we believe that it would be necessary participant to payment consequences the PFS not OPPS. We believe the solely for purposes of testing the RO under MIPS and the Model for potential differences between Model. potentially the same quality participant-specific technical episode The RO Model is a test of a site- performance could have unintended payments made for services furnished in neutral pricing methodology, where consequences. The MIPS payment HOPDs and those made under the PFS payment rates are calculated in the same adjustment factors may interfere with that would be caused by the application manner regardless of the setting and how the RO Model pricing methodology of the Hospital OQR Program payment paid prospectively based on episodes of has been conceptualized and therefore reduction would be problematic for the care. While payment amounts may vary impact the model evaluation by RO Model test by creating potentially across RO participants, the calculation introducing additional variability into misaligned incentives for RO of how much each RO participant RO participants’ payments thereby participants. The Hospital OQR Program would be paid for the PC and TC of the making it harder to discern whether the payment reduction may interfere with episode is designed to be as similar as episode-based bundled payment how the RO Model pricing methodology possible, irrespective of whether the RO approach is successful. For these has been conceptualized and therefore participant is an HOPD or a freestanding reasons, we believe that it would be impact the model evaluation by radiation therapy center. Applying the necessary to waive the requirement to introducing additional variability into MIPS payment adjustment factors apply the MIPS payment adjustment RO participants’ payments, thereby would undermine our goal of site- factors under section 1848(q)(6)(E) of making it harder to discern whether the neutral payments under the RO Model. the Act and 42 CFR 414.1405(e) that episode-based bundled payment If the requirement to apply the MIPS may otherwise apply to payments made approach is successful. payment adjustment factors were not for services billed under the waived, the participant-specific For these reasons, we believe that it professional RO Model-specific HCPCS technical episode payments made with would be necessary to waive the codes. requirement to apply the Hospital OQR respect to services furnished by MIPS Program payment reduction under eligible clinicians in freestanding c. Proposed Waiver of Requirement To section 1833(t)(17)(A)(i) of the Act and radiation therapy centers that are billed Include Technical Component Payments 42 CFR 414.1405(e) that may otherwise under the professional RO Model- in Calculation of the APM Incentive apply to payments made for services specific HCPCS codes may be increased Payment Amount billed under the technical RO Model- or decreased due to the MIPS payment specific HCPCS codes. As such, we are adjustment factors. In contrast, the MIPS We believe that it is necessary for proposing to waive application of the payment adjustment factors would not purposes of testing the RO Model to 2.0 percentage point reduction under apply to payments of claims processed exclude payments for the technical RO section 1833(t) (17) of the Act for only under the OPPS, and as a result, would Model-specific HCPCS codes (to the those APCs that include only RO Model- not apply to the participant-specific extent they might be considered specific HCPCS codes during the model technical episode payments made to payments for covered professional performance period. We seek comment participating HOPDs. We believe the services as defined in section on our proposal to waive application of potential differences between 1848(k)(3)(A) of the Act) from the the Hospital OQR Program 2.0 participant-specific technical episode ‘‘estimated aggregate payment amounts percentage point reduction through use payments made for services furnished in for covered professional services’’ used of the reporting ratio for APCs that freestanding radiation therapy centers to calculate the APM Incentive Payment include the new HCPCS codes that are and those made under the OPPS that amount under 42 CFR 414.1450(b). The created for the RO Model during the would be caused by the application of regulation at 42 CFR 414.1450(b) model performance period. the MIPS payment adjustment factors establishes the APM Incentive Payment would be problematic for the RO Model Amount; we specifically believe it is b. Proposed Waiver of the Requirement test by creating potentially misaligned necessary to exclude the technical RO To Apply the MIPS Payment incentives for RO participants as well as Model-specific HCPCS codes from the Adjustment Factors to Certain RO other challenges for the Model calculation of estimated aggregate Model Payments evaluation. We believe that without this payments for covered professional Under section 1848(q)(6)(E) of the Act waiver, model participants may be services as defined in 42 CFR and 42 CFR 414.1405(e), the MIPS incentivized to change their behavior 414.1450(b)(1). The RO Model HCPCS payment adjustment factor, and, as and steer beneficiaries towards codes are split into a professional applicable, the additional MIPS freestanding radiation therapy centers if component and a technical component payment adjustment factor (collectively they expect the MIPS payment to reflect the two types of services referred to as the MIPS payment adjustment factors would be positive, provided in the Model by the three adjustment factors) generally apply to and away from freestanding radiation different RO participant types, PGPs, the amount otherwise paid under therapy centers if they expect the MIPS HOPDs, and freestanding radiation Medicare Part B with respect to covered payment adjustment factors would be therapy centers, across different service professional services furnished by a negative. sites. RO participants would bill the

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Model-specific HCPCS codes that are services when calculating the APM using the current FFS payment relevant to their RO participant type. Incentive Payment amount. methodology and not the pricing methodology we are testing through the We believe this waiver is necessary d. Proposed General Payment Waivers because, under 42 CFR 414.1450, the Model. APM Incentive Payment amount for an We believe that it is necessary for purposes of testing the RO Model to e. Proposed Waiver of Appeals eligible clinician who is a QP is equal Requirements to 5 percent of his/her prior year waive requirements of certain sections estimated aggregate payments for of the Act, specifically with regard to We believe that it is necessary for covered professional services as defined how payments are made, in order to purposes of testing the RO Model to in section 1848(k)(3)(A) of the Act. The allow the RO Model’s prospective waive section 1869 of the Act specific technical RO Model-specific HCPCS episode payment to be fully tested. to claims appeals to the extent Therefore, we propose to waive: otherwise applicable. We propose to codes include the codes that we have • developed to bill the services on the Section 1848(a)(1) of the Act that implement this waiver so that RO included RT services list that are requires payment for physicians’ participants may utilize the proposed services to be determined under the PFS considered ‘‘technical’’ (those that timely error and reconsideration request to allow the professional and technical represent the cost of the equipment, process specific to the RO Model as component payments for RT services to supplies and personnel used to perform proposed in section III.C.12 of this be made as set forth in the RO Model. the procedure). proposed rule to review potential RO We believe that waiving section Model reconciliation errors. We would If the requirement to include 1848(a)(1) of the Act would be necessary note that, if RO participants have payments for the technical RO Model- because otherwise the proposed RO general Medicare claims issues they specific HCPCS codes in the calculation Model payments would be set by the wish to appeal (Medicare claims issues of the APM Incentive Payment amount PFS; experienced by the RO participant that were not waived, PGPs furnishing RT • Section 1833(t)(1)(A) of the Act that occur outside the scope of the RO services in freestanding radiation requires payment for outpatient Model, but during their participation in therapy centers (which are paid under department (OPD) services to be the RO Model), then the RO participants the PFS) participating in the Model determined under the OPPS to allow the should continue to use the standard would have technical RT services payments for technical component CMS claims appeals procedures under included in the calculation of the APM services to be paid as set forth in the RO section 1869 of the Act. Incentive Payment amount, but PGPs Model because otherwise the proposed We propose to implement this waiver furnishing RT services in HOPDs (which participant-specific technical episode because the proposed pricing are paid under OPPS) participating in payment would be set by the OPPS (we methodology for the RO Model is the Model would not have technical RT note that the waiver of OPPS payment unique and as such we have developed services included in the calculation of would be limited to RT services under and proposed a separate timely error the APM Incentive Payment amount. the RO Model); and notice and reconsideration request We believe these potential differences • Section 1833(t)(16)(D) of the Act process that RO participants would use between participant-specific technical regarding payment for stereotactic in lieu of the claims appeals process episode payments processed and made radiosurgery (a type of RT covered by under section 1869 of the Act. under the PFS and those made under the RO Model) to allow the payments In section III.C.12 of this proposal, we the OPPS would be problematic for the for technical component services to be propose a process for RO participants to Model test by creating potentially paid as set forth in the RO Model contest the calculation of their misaligned incentives between and because RO Model payment amounts reconciliation payment amounts, the among RO participants, as well as other would be modality agnostic and calculation of their reconciliation challenges for the Model evaluation. episodic such that all treatments and recoupment amounts, and the Specifically, we believe that, without duration of treatment for this cancer calculation of their AQS. Reconciliation this waiver, Dual participants may type are paid the same amount. payment amount means a payment change their billing behavior by shifting We propose to waive these made by CMS to a RO participant as the setting in which they furnish RT requirements because these statutory determined in accordance with services from HOPDs to freestanding provisions establish the current § 512.285. This process would ensure radiation therapy centers in order to Medicare FFS payment methodology. that individuals involved in increase the amount of participant- Without waiving these specific adjudicating these timely error notices specific technical episode payments, provisions of the Act, we would not be and reconsideration requests on these producing unwarranted increases in able to fully test whether the issues would be familiar with the their APM Incentive Payment amount. prospective episode pricing payment model being implemented and We believe this would prejudice the methodology tested under the RO Model would ensure that these issues are model testing of site neutral payments (as described in section III.C.6) is resolved in an efficient manner by as well as potentially interfere with the effective at reducing program individuals with knowledge of the Model’s design to incentivize expenditures while preserving or payment model. participants to preserve or improve enhancing the quality of care. Our proposal does not limit Medicare quality by tying performance to Specifically, as proposed, the RO Model beneficiaries’ right to the claims appeals incentive payments if participant would test whether adjusting the process under section 1869. We note, in behavior is focused on maximizing the current fee-for-service payments for RT the specific circumstance wherein a APM Incentive Payment. services to a prospective episode-based provider acts on behalf of the For these reasons, we believe that it payment model would incentivize beneficiary in a claims appeal, section would be necessary to waive the physicians to deliver higher-value RT 1869 applies. We only propose to waive requirements of 42 CFR 414.1450(b) to care. Without waiving the requirements the right of RO participants to avail the extent they would require inclusion of statutory provisions that currently themselves of the claims appeals of the technical RO Model-specific determine payments for RT services, process under section 1869 to the extent HCPCS codes as covered professional payment for RT services would be made otherwise applicable.

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f. Proposed Waiver of Amendments We invite public comments on our the RO participant owes CMS due to Made by Section 603 of the Bipartisan proposed payment waivers. incomplete episodes and duplicate services, and subtract the amount from Budget Act of 2015 11. Proposed Reconciliation Process the incorrect payment withhold amount We believe that it is necessary for We propose to conduct an annual (that is, the cumulative withhold of 2 purposes of testing the RO Model to reconciliation for each RO participant percent on episode payment amounts waive application of the PFS relativity after each PY to reconcile payments due for all episodes furnished during that adjuster which applies to payments to the RO participant with payments PY by that RO participant). This would under the PFS for ‘‘non-excepted’’ items owed to CMS due to the withhold determine the amount owed to CMS by and services identified by Section 603 of policies discussed in section III.C.6.g. the RO participant based on total the Bipartisan Budget Act of 2015 (Pub. The annual reconciliation would occur payments made to the RO participant L. 114–74), which amended section in August following a PY in order to for incomplete episodes and duplicate 1833(t)(1)(B)(v) of the Act and added allow time for claims run-out, data RT services for a given PY, if applicable. paragraph (t)(21) to the Social Security collection, reporting, and calculating A RO participant would receive the full Act. Sections 1833(t)(1)(B)(v) and (t)(21) results.61 For example, the annual incorrect payment withhold amount if it of the Act exclude certain items and reconciliation for PY1 would apply to had no duplicate RT services or services furnished by certain off-campus episodes initiated January 1, 2020 (or incomplete episodes (as explained in provider-based departments (non- April 1, 2020) through December 31, section III.C.6.g). In instances where excepted off-campus provider-based 2020, and the annual reconciliation for there are duplicate RT services or departments (PBDs)) from the definition PY1 would occur in August of 2021. We incomplete episodes, the RO participant of covered outpatient department believe that an annual reconciliation is would owe a repayment amount to CMS services for purposes of OPPS payment, appropriate because incomplete if the amount of all duplicate RT and direct payment for those services to episodes and duplicate RT services as services and incomplete episodes be made ‘‘under the applicable payment described in section III.C.6.a may result exceeds the incorrect payment withhold system’’ beginning January 1, 2017. We in additional payment owed to a RO amount. established the PFS as the ‘‘applicable participant or owed to CMS for RT • For Professional participants during payment system’’ for most non-excepted services furnished to a RO beneficiary in the Model’s performance period: If the items and services furnished in non- those cases. RO participant is a Professional excepted off-campus PBDs (81 FR a. Proposed True-Up Process participant, then we would add the 79699) and, in order to facilitate Professional participant’s incomplete We propose to conduct an annual payment under the PFS, we apply a PFS episode reconciliation amount to the true-up of reconciliation for each PY, relativity adjuster that is currently set at quality reconciliation amount. The which would mean the process to 40 percent of the OPPS rate (82 FR quality reconciliation amount would be calculate additional payments or determined by multiplying the 53027). We also require OPDs to use the repayments for incomplete episodes and modifier ‘‘PN’’ on applicable OPPS participant’s AQS (as a percentage) duplicate RT services that are identified against the total two-percentage point claim lines to identify non-excepted after claims run-out. More specifically, items and services furnished in non- maximum amount as described in we would true-up the PY1 section III.C.8.f(2). excepted off-campus PBDs. The reconciliation approximately one year • modifier triggers application of the PFS For Technical participants in PY1 after the initial reconciliation results and PY2: If the RO participant is a relativity adjuster in CMS’ claims were calculated. This would align the processing systems. Technical participant then the PY2 reconciliation of the following year Technical participant’s reconciliation Under the RO Model, we propose to with the PY1 true-up, thereby allowing amount would be equal to the waive requirements under section for a full claims run-out, and reducing incomplete episode reconciliation 1833(t)(1)(B)(v) and (t)(21) of the Act for potential confusion for RO participants. amount. There would be no further all RO Model-specific payments to We would follow the same process each additions or subtractions. applicable OPDs. If a non-excepted off- performance year. We would true-up the • For Technical participants in PY3, campus PBD were to participate in the PY1 reconciliation approximately one PY4, and PY5: We would add the RO Model, it would be required to year after the initial reconciliation Technical participant’s incomplete submit RO Model claims consistent proposed in § 512.285.section III.C.11. episode reconciliation amount to the with our professional and technical As a result, we would conduct a true- patient experience reconciliation billing proposals in III.C.7. In addition, up of PY1 in August 2022, a true-up of amount, proposed in section III.C.6.g(3). we would not apply the PFS relativity PY2 in August 2023, and so forth. Technical participants and Dual adjuster to the RO Model payment and We invite public comments on our participants could earn up to the full would instead pay them in the same proposed true-up process. amount of the patient experience manner as other RO Model participants b. Proposed Reconciliation Amount withhold (1 percent of the technical because the RO Model pricing Calculation episode payment amounts) for a given methodology’s design as described in performance year based on their results Section III.C.6.c sets site-neutral To calculate a reconciliation payment from the patient-reported CAHPS® amount either owed to a RO participant national base rates, and adding the PFS Cancer Care Radiation Therapy Survey. relativity adjuster to the RO Model by CMS or a reconciliation repayment • For Dual participants in PY1 and payment for RO participants that are amount owed by CMS to a RO PY2: We would add the Dual non-excepted off-campus PBDs would participant, we propose the following participant’s incorrect payment disrupt this approach and introduce a process: reconciliation amount to the quality • Calculate the incorrect payment payment differential. We believe this reconciliation amount. The quality reconciliation amount: Sum all money waiver is necessary to allow for reconciliation amount would be consistent model evaluation and ensure determined by multiplying the Dual 61 Claims run-out is the period of time that CMS site neutrality in RO Model payments, allows for the timely submission of claims by participant’s AQS (in percentage terms) which is a key feature of the RO Model. providers and suppliers before reconciliation. against the total two-percentage point

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maximum withhold amount as We invite public comment on our billed by the time of reconciliation. In described in section III.C.8.f(2). proposal on calculating reconciliation this example, the payments for • For Dual participants in PY3, PY4, and amounts. duplicate RT services and incomplete PY5: We would add the Dual participant’s Table 10 represents an example episodes would be subtracted from the incorrect payment reconciliation amount to reconciliation for a Professional incorrect payment withhold amount to the quality reconciliation amount. The participant. The numbers listed in the render $1,500 due to the participant quality reconciliation amount would be table are illustrative only. In this from CMS for the incorrect payment determined by multiplying the participant’s example, the incorrect payment reconciliation amount (a). This amount AQS (in percentage terms) against the total withhold amount for this Professional is then added to the quality two-percentage point maximum withhold participant is $6,000 or 2 percent of reconciliation amount (b). The quality amount as described in section III.C.8.f(2). $300,000 (the total payments for this withhold amount for this participant is Then, we would add the Dual participant’s participant after the trend factor, also $6,000 or 2 percent of $300,000. patient experience reconciliation amount to adjustments, and discount factor have This participant’s performance on the this total. been applied). The Professional AQS entitles them to 85 percent of the participant owes CMS $3,000 for quality withhold, and, therefore, when The geographic adjustment and the 2 duplicate payments due to claims the quality reconciliation amount (b) is percent adjustment for sequestration submitted on behalf of beneficiaries added to the incorrect payment would be applied to the incorrect who received RT services by another withhold amount (a), and a total payment withhold, quality withhold, provider or supplier during their payment of $6,600 total reconciliation and patient experience withhold episode. Lastly, the Professional payment (c) is due to the participant amounts during the reconciliation participant owes CMS $1,500 for cases from CMS for that performance year. We process. Beneficiary coinsurance would of incomplete episodes whereby the PC note that this example does not include be waived for the reconciliation of the episode was billed and due to the geographic adjustment or the 2 payment and repayment amounts. death or other reason, the TC was not percent adjustment for sequestration.

12. Proposed Timely Error Notice and participants have Medicare FFS claims Model. Specifically, we believe it is Reconsideration Request Processes or decisions they wish to appeal (that is, necessary to establish a means for RO Medicare FFS issues experienced by the participants to dispute suspected errors We believe it is necessary to RO participant that occur outside the in the calculation of their reconciliation implement timely error notice and scope of the RO Model but during their reconsideration request processes under payment amount, repayment amount, or participation in the RO Model), then the which RO participants may dispute AQS. Having RO participants utilize the RO participants should continue to use suspected errors in the calculation of standard claims appeals process under the standard CMS procedures through their reconciliation payment amount or section 1869 of the Act to appeal the repayment amount (proposed in section their Medicare Administrative calculation of their reconciliation III.C.11), or AQS (proposed in section Contractor. Section 1869 of the Act payment amount, repayment amount, or III.C.8.f(1)) as reflected on a RO provides for a process for Medicare AQS would not lead to timely reconciliation report that has not been beneficiaries, providers, and suppliers resolution of disputes because MACs deemed final. Therefore, we are to appeal certain claims decisions made and other CMS officials will not have proposing a policy that would permit by CMS. access to beneficiary attribution data, RO participants to contest errors found However, we propose to waive the and the standard claims appeals process in the RO reconciliation report, but not requirements of section 1869 of the Act hierarchy would not engage the the RO Model pricing methodology or specific to claims appeals as necessary Innovation Center and its contractors AQS methodology. We note that, if RO solely for purposes of testing the RO until late in the process. Accordingly,

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we propose a two-level process for RO 1115A(d)(2) of the Act and proposed If the RO participant did timely participants to request reconsideration § 512.290. We propose that this written submit a timely error notice and the RO of determinations related to calculation notice must be submitted in a form and participant is dissatisfied with CMS’s of their reconciliation payment, manner specified by CMS. Unless the response to the timely error notice, the recoupment amount, or AQS under the RO participant provides such notice, the RO participant would be permitted to RO Model. We propose the first level to RO participant’s reconciliation payment request reconsideration review by a be a timely error notice process and the amount, repayment amount, or AQS CMS reconsideration review official. To second level to be reconsideration would be deemed final after 30 days, be considered, we propose that the review process, as subsequently and CMS would proceed with payment reconsideration review request must discussed. The processes proposed here or repayment, as applicable. If CMS provide a detailed explanation of the are based on the processes implemented receives a timely notice of an error, we basis for the dispute and include under certain current models being propose that CMS would respond in supporting documentation for the RO tested by the Innovation Center. writing within 30 days to either confirm participant’s assertion that CMS or its We propose that only RO participants that there was a calculation error or to representatives did not accurately may utilize either the first or second verify that the calculation is correct. calculate the reconciliation payment level of the reconsideration process, CMS would reserve the right to an amount, repayment, recoupment unless otherwise stated in other sections extension upon written notice to the RO amount, or AQS in accordance with the of this proposed subpart. We believe participant. We propose to codify this terms of the RO Model. that only RO participants should be able timely error notice policy at We propose that the reconsideration to utilize the proposed process because § 512.290(a). review would be an on-the-record non-participants will not receive review (a review of the memoranda or calculation of a reconciliation payment 2. Reconsideration Review briefs and evidence only) conducted by amount, repayment amount, or AQS, We propose that the second level of a CMS reconsideration official. The and will generally have access to the the proposed reconsideration process CMS reconsideration official would section 1869 claims appeals processes to would permit RO participants to dispute make reasonable efforts to notify the RO appeal the payments they receive under CMS’s response to the RO participant’s participant and CMS in writing within the Medicare program. identification of errors in the timely 15 days of receiving the RO participant’s reconsideration review request of the 1. Timely Error Notice error notice, by requesting a reconsideration review by a CMS following: The issues in dispute, the In some models currently being tested briefing schedule, and the review by the Innovation Center, CMS provides reconsideration official. As is the case for many models currently being tested procedures. The briefing schedule and model participants with a courtesy copy review procedures would lay out the of the settlement report for their review, by the Innovation Center, we propose that the CMS reconsideration official timing for the RO participant and CMS allowing them to dispute suspected to submit their position papers and any would be a designee of CMS who is calculation errors in that report before other documents in support of their authorized to receive such requests who the payment determination is deemed position papers; the review procedures was not involved in the responding to final. Other models currently being would lay out the procedures the the RO participant’s timely error notice. tested by the Innovation Center make reconsideration official will utilize We are proposing that, to be considered, model-specific payments in response to when reviewing the reconsideration the reconsideration review request must claims or on the basis of model review request. The CMS be submitted to CMS within 10 days of beneficiary attribution that are similarly reconsideration official would make all the issue date of CMS’ written response subject to a model-specific process for reasonable efforts to complete the on- to the timely error notice. We propose resolving disputes. In some models the-record review of all the documents currently being tested by the Innovation the reconsideration review request submitted by the RO participant and Center, these reconsideration processes would be submitted in a form and issue a written determination within 60 involve two levels of review. manner specified by CMS. days after the submission of the final Building off of these existing As there would not otherwise be a position paper in accordance with the processes, we propose that the first level timely error notice response for the reconsideration official’s briefing of the proposed reconsideration process reconsideration official to review, we schedule. As this is the final step of the would be a timely error notice. are proposing that in order to access the Innovation Center administrative Specifically, we are proposing that RO reconsideration review process, a RO dispute resolution process, we propose participants could provide written participant must have timely submitted that the determination made by the CMS notice to CMS of a suspected error in a timely error notice to CMS in the form reconsideration official would be final the calculation of their reconciliation and manner specified by CMS, and this and binding. This proposed payment amount, repayment amount, or timely error notice must not have been reconsideration review process is AQS for which a determination has not precluded from administrative and consistent with other resolution yet been deemed to be final under the judicial review. Specifically, where the processes used throughout the agency. terms of this proposed part. The RO RO participant does not timely submit We propose to codify this participant shall have 30 days from the a timely error notice with respect to a reconsideration review process at date the RO reconciliation report is particular reconciliation payment § 512.290(b). issued to provide their timely error amount, repayment, recoupment We invite public comment on these notice. This would be subject to the amount, or AQS, we propose the proposed provisions regarding the limitations on administrative and reconsideration review process would proposed timely error notice and judicial review as previously described. not be available to the RO participant reconsideration review processes. Specifically, a RO participant could not with regard to the RO participant’s use the timely error notice process to reconciliation payment amount; the 13. Proposed Data Sharing dispute a determination that is calculation of the RO participant’s CMS has experience with a range of precluded from administrative and repayment amount; or the calculation of efforts designed to improve care judicial review under section the RO participant’s AQS. coordination and the quality of care,

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and decrease the cost of care for redesign and care coordination participants may be required to provide beneficiaries, including models tested purposes. information on the number of Medicare under section 1115A, most of which and non-Medicare patients treated with b. RO Participant Public Release of make certain types of data available radiation during their participation in Patient De-Identified Information upon request to model participants. the Model. We propose to require RO Based on the design elements of each We are not proposing to restrict RO participants’ submission of additional model, the Innovation Center may offer participants’ ability to publicly release administrative data upon a request from participants the opportunity to request patient de-identified information that CMS, such as the RO participant’s costs different types of data, so that they can references the RO participant’s to provide care (such as the acquisition redesign their care pathways to preserve participation in the RO Model. cost of a linear accelerator) and how or improve quality and coordinate care Information that RO participants may frequently the radiation machine is used for model beneficiaries. Furthermore, as publicly release about their on an average day; current EHR previously described, we believe it is participation in the RO Model may vendor(s); and accreditation status. We necessary for the Innovation Center to include, but is not limited to, press propose to do this through annual web- require certain data to be reported by releases, journal articles, research based surveys. The data requested for model participants to CMS in order to articles, descriptive articles, external use under the RO Model will be used to evaluate and monitor the proposed reports, and statistical/analytical better understand participants’ office model, including the model materials describing the RO activities, benchmarks, and track participant’s participation in the participant’s participation and patient participant compliance. proposed model, which could then also results in the RO Model that have been de-identified in accordance with HIPAA d. Proposed Data Provided to RO be used to inform the public and other Participants model participants regarding the impact requirements in 45 CFR 164.514(b). In of the proposed model on both program order to ensure external stakeholders Thirty (30) days prior to the start of spending and the quality of care. understand that information the RO each PY, we propose to provide RO participant releases represents their own participants with updated participant- a. Data Privacy Compliance content and opinion, and does not specific professional episode payment reflect the input or opinions of CMS, we and technical episode payment amounts In proposed § 512.275(a), we propose propose to require the RO participant to (for example, episode price files) for that, as a condition of their receipt of include a disclaimer on the first page of each included cancer type. RO patient-identifiable data from CMS for any such publicly released document, participants, to the extent allowed by purposes of the RO Model, RO the content of which materially and HIPAA and other applicable law, could participants must comply with all substantially references or relies upon reuse individually identifiable claims applicable laws pertaining to any the RO participant’s participation in the data that they request from CMS for care patient-identifiable data requested from RO Model. We propose to utilize the coordination or quality improvement CMS under the terms of the RO Model same disclaimer for public release of work and in their assessment of CMS’ and the terms of any agreement entered information by the RO participant that calculation of their participant-specific into by the RO participant and CMS as we propose to codify at § 512.120(c)(2) episode payment amounts and/or a condition of the RO participant for purposes of descriptive model amounts included in the reconciliation receiving such data. These laws include, materials and activities: ‘‘The calculations used to determine the without limitation, the standards for the statements contained in this document reconciliation payment amount or privacy of individually identifiable are solely those of the authors and do recoupment amount, as applicable. To health information and the security not necessarily reflect the views or seek such care coordination and quality standards for the protection of policies of the Centers for Medicare & improvement data RO participants electronic protected health information Medicaid Services (CMS). The authors should use a Participant Data Request under the regulations promulgated assume responsibility for the accuracy and Attestation (DRA) form, which will under the Health Insurance Portability and completeness of the information be available on the RO Model website. and Accountability Act of 1996 (HIPAA) contained in this document.’’ We are Throughout the model performance and the Health Information Technology proposing to require the use of this period, RO participants may request to for Economic and Clinical Health Act disclaimer so that the public, and RO continue to receive these data until the (HITECH). Additionally, we are beneficiaries in particular, are not final reconciliation and final true-up proposing that RO participants would misled into believing that RO process has been completed if they be required to contractually bind all participants are speaking on behalf of continue to use such data for care downstream recipients of CMS data to the agency. coordination and quality improvement comply with all laws pertaining to any purposes. At the conclusion of this patient-identifiable data requested from c. Proposed Data Submitted by RO process, the RO participant would be CMS and the terms of any agreement Participants required to maintain or destroy all data that the RO participant enters into with In addition to the quality measures in its possession in accordance with the CMS as a condition of receiving the data and clinical data described in section DRA and applicable law. under the RO Model, as a condition of III.C.8, we propose that RO participants We further propose that the RO the downstream recipient’s receipt of supply and/or confirm a limited amount participant may reuse original or the data from the RO participant and of summary information to CMS. This derivative data without prior written their maintenance thereof. We believe information includes the RO authorization from us for clinical requiring RO participants to bind their participant’s TIN in the case of a treatment, care management and downstream recipients in writing to freestanding radiation therapy center coordination, quality improvement comply with applicable law and and PGP, or CCN in the case of a HOPD. activities, and provider incentive design requirements is necessary to protect the We would require RO participants to and implementation, but shall not individually identifiable health supply and/or confirm the NPIs for the disseminate individually identifiable information data that may be shared physicians who bill for RT services original or derived information from the with RO participants by CMS for care using the applicable TINs. RO files specified in the Model DRA to

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anyone who is not a HIPAA Covered to the RO participant in response to a disclosed in any way from or by the site Entity Participant or individual DRA would not include any beneficiary- of the Data Custodian indicated in the practitioner in a treatment relationship level claims data regarding utilization of DRA without written approval from with the subject Model beneficiary; a substance use disorder services unless CMS, unless such movement, HIPAA Business Associate of such a the requestor provides a 42 CFR part 2- transmission, or disclosure is required Covered Entity Participant or individual compliant authorization from each by a law. At the conclusion of the RO practitioner; the participant’s business individual about whom they seek such Model and reconciliation process, the associate, where that participant is itself data. While the proffered DRA form was RO participant would be required to a HIPAA Covered Entity; the drafted with the assumption that most destroy all data in its possession as participant’s sub-business associate, RO participants seeking claims data will agreed upon under the DRA. which is hired by the RO participant to do so under the HIPAA Privacy Rule 14. Proposed Monitoring and carry out work on behalf of the Covered provisions governing ‘‘health care Compliance Entity Participant or individual operations’’ disclosures under 45 CFR practitioners; or a non-participant 164.506(c)(4), in offering RO If finalized, the general provisions HIPAA Covered Entity in a treatment participants the opportunity to use that relating to monitoring and compliance relationship with the subject Model form to request beneficiary-identifiable proposed in section II.I of this rule beneficiary. claims data, we do not represent that the would apply to the RO Model. When using or disclosing PHI or RO participant or any of its individual Specifically, RO participants would be personally identifiable information (PII) practitioners has met all applicable required to cooperate with the model obtained from files specified in the HIPAA requirements for requesting data monitoring and evaluation activities in DRA, the RO participant would be under 45 CFR 164.506(c)(4). The RO accordance with § 512.130, comply with required to make ‘‘reasonable efforts to participant and its individual the government’s the right to audit, limit’’ the information to the ‘‘minimum practitioners should consult their own inspect, investigate, and evaluate any necessary’’ as defined by 45 CFR counsel to make those determinations documents or other evidence regarding 164.500 through 164.534 to accomplish prior to requesting data using the DRA implementation of the RO Model under the intended purpose of the use, form. § 512.135(a), and to retain and provide disclosure or request. The RO the government with access to records Agreeing to the terms of the DRA, the participant would be required to further in accordance with §§ 512.135(b) and RO participant, at a minimum, would limit its disclosure of such information (c). Additionally, CMS would conduct to what is permitted by applicable law, agree to establish appropriate model monitoring activities with respect including the regulations promulgated administrative, technical, and physical to the RO Model in accordance with under the HIPAA and HITECH laws at safeguards to protect the confidentiality § 512.150(b). We believe that the general 45 CFR part 160 and subparts A and E of the data and to prevent unauthorized provisions relating to monitoring and of part 164, and the types of disclosures use of or access to it. The safeguards compliance are appropriate for the RO that the Innovation Center itself would would be required to provide a level Model, because we must closely be permitted to make under the ‘‘routine and scope of security that is not less monitor the implementation and uses’’ in the applicable systems of than the level and scope of security outcomes of the RO Model throughout records notices listed in the DRA. We requirements established for federal its duration. The purpose of monitoring propose that the RO participant may agencies by the Office of Management would be to ensure that the Model is link individually identifiable and Budget (OMB) in OMB Circular No. implemented safely and appropriately; information specified in the DRA A–130, Appendix I—Responsibilities for that RO participants comply with the (including directly or indirectly Protecting and Managing Federal terms and conditions of this rule; and to identifiable data) or derivative data to Information Resources (available at protect beneficiaries from potential other sources of individually https://www.whitehouse.gov/omb/ harms that may result from the activities _ identifiable health information, such as circulars default) as well as Federal of a RO participant. other medical records available to the Information Processing Standard 200 Consistent with § 512.150(b), we participant and its individual entitled ‘‘Minimum Security anticipate that monitoring activities may practitioner. The RO participant would Requirements for Federal Information include documentation requests sent to be authorized to disseminate such data and Information Systems’’ (available at RO participants and individual that has been linked to other sources of http://csrc.nist.gov/publications/fips/ practitioners on the individual individually identifiable health fips200/FIPS-200-final-march.pdf); and, practitioner list; audits of claims data, information provided such data has NIST Special Publication 800–53 quality measures, medical records, and been de-identified in accordance with ‘‘Recommended Security Controls for other data from RO participants and HIPAA requirements in 45 CFR Federal Information Systems’’ (available clinicians on the individual practitioner 164.514(b). at http://nvlpubs.nist.gov/nistpubs/ list; interviews with members of the We invite public comment on our SpecialPublications/NIST.SP.800- staff and leadership of the RO proposals related to data sharing for the 53r4.pdf). The RO participant would be participant and clinicians on the RO Model. required to acknowledge that the use of individual practitioner list; interviews unsecured telecommunications, with beneficiaries and their caregivers; f. Access To Share Beneficiary including insufficiently secured monitoring quality outcomes; site visits; Identifiable Data transmissions over the internet, to monitoring quality outcomes and As discussed earlier in this proposed transmit directly or indirectly clinical data, if applicable; and tracking rule, in advance of each PY and any identifiable information from the files patient complaints and appeals. We other time deemed necessary by us, we specified in the DRA or any such anticipate using the most recent claims will offer the RO participant an derivative data files would be strictly data available to track utilization as opportunity to request certain data and prohibited. Further, the RO participant described in section III.C.7, and reports through a standardized DRA, if would be required to agree that the data beneficiary outcomes under the Model. appropriate to that RO participant’s specified in the DRA would not be More specifically, we may track situation. The data and reports provided physically moved, transmitted, or utilization of certain types of treatments,

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beneficiary hospitalization and consistency, and completeness; further metastasis (TNM) cancer stage for the emergency department use, and information on this analysis will be CMS-specified cancer diagnoses; (iv) fractionation (numbers of treatments) provided to RO participants in a time assesses the RO beneficiary’s against historical treatment patterns for and manner specified by CMS prior to performance status as a quantitative each participant. We believe this type of collection of this data. We would use measure determined by the physician; monitoring is important because as RO existing authority to audit claims and (v) sends a treatment summary to each participants transition from receiving services, to use the QIO to assess for RO beneficiary’s referring physician FFS payment to receiving new (episode- quality issues, to use our authority to within three months of the end of based) payment, we want ensure to the investigate allegations of patient harm, treatment to coordinate care; (vi) greatest extent possible that the Model and to monitor the impact of the RO discusses with each RO beneficiary is effective and that RO Model Model quality metrics. We may monitor prior to treatment delivery his or her beneficiaries continue to receive high- participants to detect issues with inclusion in, and cost-sharing quality and medically appropriate care. beneficiary experience of care, access to responsibilities under, the RO Model; Additionally, we may employ longer- care, or quality of care. We may monitor and (vii) performs and documents Peer term analytic strategies to confirm our the Medicare claims system to identify Review (audit and feedback on ongoing analyses and detect more subtle potentially adverse changes in referral, treatment plans) for 50 percent of new or hard-to-determine changes in care practice, or treatment delivery patterns. patients in PY1, for 55 percent of new delivery and beneficiary outcomes. We invite public comment on our patients in PY2, for 60 percent of new Some determinations of beneficiary proposal. patients in PY3, for 65 percent of new outcomes or changes in treatment b. Proposed Monitoring for Model patients in PY4, and for 70 percent of delivery patterns may not be able to be Compliance new patients in PY5 preferably before built into ongoing claims analytic efforts starting treatment, but in all cases before and may require longer-term study. This As explained in section III.C.9, we 25 percent of the total prescribed dose work may involve pairing clinical data propose to require all participants to has been delivered and within 2 weeks with claims data to identify specific annually attest in a form and manner of the start of treatment. issues by cancer type. specified by CMS that they would use We invite public comment on this CEHRT throughout such PY in a manner proposal. a. Proposed Monitoring for Utilization/ sufficient to meet the requirements as Costs and Quality of Care set forth in 42 CFR 414.1415(a)(1)(i). In c. Proposed Performance Feedback We would monitor RO participants addition, we further propose that each We propose to provide detailed and for compliance with RO Model Technical participant and Dual actionable information regarding RO requirements. We anticipate monitoring participant would be required to attest participant performance related to the to detect possible attempts to annually that it actively participates in RO Model. We intend to leverage the manipulate the system through patient a radiation oncology-specific AHRQ- clinical data to be collected through the recruitment and billing practices. The listed patient safety organization (PSO). model-specific data collection system, pricing methodology requires certain This attestation would be required to quality measure results reported by RO assumptions about patient ensure compliance with this RO Model participants, claims data, and characteristics, such as diagnoses, age, requirement. CMS may change these compliance monitoring data to provide and stage of disease, based on the intervals throughout the Model upon information to participants on their historical case mix of the individual advanced written notice to the RO adherence to evidence-based practice participants. It also assigns payments by participants. We propose to codify these guidelines, quality and patient cancer type. Because of these features, RO Model requirements at experience measures, and other quality participants could attempt to § 512.220(a)(3). We note that CMS may initiatives. We believe these reports can manipulate patient recruitment in order monitor the accuracy of such drive important conversations and to maximize revenue (for example, attestations and that false attestations support quality improvement progress. cherry-picking, lemon-dropping, or would be punishable under applicable The design of and frequency that these shifting patients to a site of service for federal law. reports would be provided to In addition, we would monitor for which the participant bills Medicare participants would be determined in compliance with the other RO Model that is not in a randomly selected conjunction with the RO Model requirements listed in this section CBSA). We anticipate monitoring implementation and monitoring through site visits and medical record compliance with RO Model-specific contractor. billing guidelines and adherence to audits conducted in accordance with We invite public comment on our current LCDs which provide § 512.150. We propose to codify at proposal. information about the only reasonable § 512.220(a)(2) to require that all and necessary conditions of coverage Professional participants and Dual d. Proposed Remedial Action for Non- allowed. We also intend to monitor participants document in the medical Compliance patient and provider/supplier record that the participant: (i) Has We refer readers to section II.J of this characteristics, such as variations in discussed goals of care with each RO proposed rule for our proposals size, profit status, and episode beneficiary before initiating treatment regarding remedial and administrative utilization patterns, over time to detect and communicated to the RO action. changes that might suggest attempts at beneficiary whether the treatment intent such manipulation. is curative or palliative; (ii) adheres to 15. Beneficiary Protections To allow us to conduct this nationally recognized, evidence-based We propose to require Professional monitoring, RO participants would clinical treatment guidelines when participants and Dual participants to report data on program activities and appropriate in treating RO beneficiaries notify RO beneficiaries that the RO beneficiaries consistent with the data or document in the medical record the participant is participating in this RO collection policies proposed in section rationale for the departure from these Model by providing written notice to III.C.8. These data would be analyzed by guidelines; (iii) assesses the RO each RO beneficiary during the RO CMS or our designee for quality, beneficiaries’ tumor, node, and beneficiary’s initial treatment planning

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session. We intend to provide a Our evaluation would focus primarily approach to estimate model effects. notification template that RO on understanding how successful the Where it is available, baseline data for participants may personalize with their Model is in achieving improved quality the participants would be obtained for contact information and logo, which and reduced expenditures as evidenced at least one year prior to model would explain that the RO participant is by changes in RT utilization patterns implementation. Data would also be participating in the RO Model and (including the number of fractions and collected during model implementation would include information regarding types of RT), RT costs for Medicare FFS for both participant and comparison RO beneficiary cost-sharing beneficiaries in the RO Model groups. The evaluation would control responsibilities and a RO beneficiary’s (including Medicare-Medicaid dually for patient differences and other factors right to refuse having his or her data eligible beneficiaries), changes in that directly and indirectly affect the RO shared under § 512.225(a)(2). utilization and costs with other services Model impact estimate, including Beneficiaries who do not wish to have that may be affected as a result of the demographics, comorbidities, program their data shared under the Model RO Model (such as emergency eligibility, and other factors. Data to would be able to notify their respective department services, imaging, control for patient differences would be RO participant; in such cases the RO prescription drugs, and inpatient obtained primarily from claims and participant must notify in writing CMS hospital care), performance on clinical patient surveys. within 30 days of when the beneficiary care process measures (such as adhering The evaluation would use a notifies the RO participant. to evidence-based guidelines), patient multilevel approach. We would conduct We believe it would be important that experience of care, and provider analyses at the CBSA-level, participant- RO participants provide RO experience of care. The evaluation level, and the beneficiary-level. The beneficiaries with a standardized, CMS- would inform the Secretary and CBSAs and RT providers and RT developed RO beneficiary notice in policymakers about the impact of the suppliers contained within selected order to limit the potential for fraud and model relative to the current Medicare CBSA geographic areas, as discussed in abuse, including patient steering. We fee structure for RT services, assessing section III.C.3.d, would have been propose that the required RO Model the impacts on beneficiaries, providers, randomly assigned for the duration of beneficiary notice be exempt from the markets, and the Medicare program. The the evaluation, allowing us to use requirement at § 512.120(c)(2) and in evaluation would take into account scientifically rigorous methods for section II.D.3 of this part, which other models and any changes in evaluating the effect of the Model. requires that the model participant Medicare payment policy during the We refer readers to section II.E of this include a disclaimer statement on all model performance period. proposed rule for our proposed policy descriptive model materials and In addition to assessing the impact of on RO participant cooperation with the activities that ‘‘The statements the Model in achieving improved RO Model’s evaluation and monitoring contained in this document are solely quality and reduced Medicare policies. We invite public comment on those of the authors and do not expenditures, the evaluation is likely to our proposed approach related to the necessarily reflect the views or policies address questions that include (but evaluation of the RO Model. of the Centers for Medicare & Medicaid would not be limited to): Did utilization 17. Termination of the RO Model Services (CMS). The authors assume patterns with respect to modality or responsibility for the accuracy and number of fractions per episode change The proposed general provisions completeness of the information under the model? If the Model results in relating to termination of the Model by contained in this document.’’ We lower Medicare expenditures, what CMS proposed in section II.J of this rule believe that such statement should not aspects of the Model reduced spending would apply to the RO Model. apply to the proposed RO Model and were those changes different across 18. Potential Overlap With Other beneficiary notice, because RO subgroups of beneficiaries or related to Models Tested Under Section 1115A participants would be required to use observable geographic or socio- Authority and CMS Programs standardized language developed by economic factors? Did any observed CMS. We propose these policies at differences in concordance with a. Overview § 512.225(c). evidence-based guidelines vary by The RO Model would leverage If beneficiaries have any questions or cancer type or by treatment modality? existing Innovation Center work and concern with their physicians, we Did patient experience of care improve? initiatives, broadening that experience encourage them to telephonically Did the Model affect access to RT or to RT providers and RT suppliers, a contact the CMS using 1–800– other services overall or for vulnerable professional population that is not MEDICARE, or their local Beneficiary populations? Were there design and currently the focus of other models and Family Centered Care–Quality implementation issues with the RO tested by the Innovation Center. We Improvement Organizations (BFCC– Model? What changes did participating believe that the RO Model would be QIOs) (local BFCC–QIO contact radiation oncologists and other RO care compatible with other CMS models and information can be located here: https:// team members experience under the qioprogram.org/beneficiary-and-family- Model? Did any unintended case, the RO participant) and comparison (in this centered-care-national-coordinating- case, the Comparison group) groups during the consequences of the Model emerge? Was period before the RO Model goes into effect (pre- center). there any observable overlap between intervention) and the period during and after the We invite public comment on the the RO Model and other CMMI models RO Model goes into effect (post-intervention) and proposed beneficiary protections. or CMS/non-CMS initiatives and how uses the difference between intervention and comparison in both periods to estimate the effect of 16. Proposed Evaluation could they impact the evaluation the intervention. A comparison group that is similar findings? to the intervention group is used to help measure An evaluation of the RO Model would CMS anticipates that the evaluation the size of the intervention effect by providing a be required to be conducted in would include a difference-in- comparison (or ‘counterfactual’) to what would accordance with section 1115A(b)(4) of 62 have happened to the intervention group had the differences or similar analytic intervention not occurred. This helps the evaluation the Act, which requires the Secretary to distinguish between changes occurring for reasons evaluate each model tested by the 62 Difference-in-difference is a statistical unrelated to the model when estimating the changes Innovation Center. technique that compares the intervention (in this that occurred because of the model.

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programs that also provide health care initiative receives care at a radiation coordination and management and entities with opportunities to improve oncology provider or supplier outside seeks to improve care and reduce costs care and reduce spending. We expect the ACO that is participating in the RO for cancer patients receiving that there would be situations where a Model. chemotherapy. Given the significant Medicare beneficiary in a RO Model While shared savings payments made cost of RT, OCM episodes that include episode would also be assigned to, or under an ACO initiative have the RT services receive a risk adjustment engage with, another payment model potential to overlap with discounts and when calculating episode benchmarks, being tested by CMS. Overlap could also withholds in the RO Model, it is with the goal of mitigating incentives to occur among providers and suppliers at difficult to determine the level of shift these services outside the episode the individual or organization level; for potential overlap at this time. It is also (for example, by delaying the provision example, a physician or organization difficult to determine how many aligned of RT services until after the 6-month could be participating in multiple ACO beneficiaries would require RT episode ends). models tested by the Innovation Center. services or if those beneficiaries would Practices participating in OCM We believe that the RO Model would be seek care from a RO participant. Given receive a monthly payment per OCM compatible with other CMS initiatives that the RO Model is expected to reduce beneficiary to support enhanced that provide opportunities to improve Medicare spending in aggregate, we services such as patient navigation and care and reduce spending, especially anticipate that in most cases payments care planning. Practices may also earn a population-based models, though we under the RO Model would be less than PBP for reductions in the total cost of recognize the design of some models what Medicare would have paid outside care compared to episodes’ target being tested by the Innovation Center the Model. It is possible, however, for amount, with the amount of PBP being under its section 1115A authority could RO participants to receive higher adjusted by the practice’s performance create unforeseen challenges at the Medicare payments under the Model on quality measures. OCM offers organization, clinician, or beneficiary than they did historically, for example, participating practices the option of level. Currently, we do not envision that if they have certain experience requesting a two-sided risk arrangement, the prospective episode payments made adjustments. While we expect overall in which episode expenditures that under the RO Model would need to be payments for RT services to be lower exceed the target amount or the target adjusted to reflect payments made than they would be absent the Model, amount plus the minimum threshold for under any of the existing models being we want to ensure that a significant OCM recoupment (depending on the tested under section 1115A of the Act or proportion of the RO Model discounts, specific two-sided risk arrangement the Medicare Shared Savings Program which represent Medicare savings, requested) would be recouped by CMS (Shared Savings Program) under section would not be paid out as shared savings. from the practice. OCM requires 1899 of the Act. If, in the future, we Due to these factors, we intend to participating practices who have not determine that such adjustments are continue to review the potential overlap earned a PBP by the initial necessary, we would propose overlap with the ACO initiatives as the RO reconciliation of the model’s fourth policies for the RO Model through Model is launched. If substantial performance period to move to a two- notice and comment rulemaking. overlap occurs, we would consider sided risk arrangement or terminate adjusting the RO Model payments their participation in the model. b. Accountable Care Organizations through future rulemaking to ensure As proposed in section III.C.7, the RO (ACOs) Medicare retains the discount amount. Model would include prospective We believe there would be potential ACO initiatives could also consider episode payments for RT services overlap between the proposed RO accounting for RO Model overlap in furnished during a 90-day episode of Model and ACO initiatives. ACO their own reconciliation calculations. care. The RO Model is not a total cost initiatives include a shared savings Any changes to these calculations that of care model and only includes RT component. As a result, providers and might be necessary due to the overlap services in the episode payment. Since suppliers that participate in an ACO are with the RO Model would be made the RO Model makes prospective generally prohibited from participating using the applicable ACO initiative payments for only the RT services in other CMS models or initiatives procedures. provided during an episode, a practice involving shared savings.63 We believe participating in the RO Model would c. Oncology Care Model (OCM) there would be potential for overlap receive the same prospective episode between the RO Model and ACO OCM seeks to provide higher quality, payment for RT services regardless of its initiatives but, because the RO Model is more highly coordinated oncology care participation in OCM. an episode-based payment initiative, at the same or lower cost to Medicare. Conversely, OCM is a total cost of care providers and suppliers participating in OCM episodes encompass a 6-month model so any changes in the cost of RT the RO Model would not be precluded period that is triggered by the receipt of services during an OCM episode could from also participating in an ACO chemotherapy and incorporate all affect OCM episode expenditures, and initiative. Specifically, we believe aspects of care during that timeframe, therefore, have the potential to affect a overlap could likely occur in two including RT services. Because OCM participating practice’s PBP or instances: (1) The same provider or and the RO Model both involve care for recoupment. When the RO Model supplier participates in both a Medicare patients with a cancer diagnosis who episode occurs completely before or ACO initiative and the RO Model; or (2) receive RT services, we expect that there completely after the OCM episode, then a beneficiary that is aligned to an ACO would be beneficiaries who would be in the RT services that are part of that RO participating in a Medicare ACO both OCM episodes and the RO Model Model episode would not be included episodes. in the OCM episode, and the OCM 63 The statutory limitation under § 1899(b)(4)(A) Under OCM, physician practices may reconciliation calculations would be of the Social Security Act, only applies to providers receive a performance-based payment unaffected. If an entire RO Model and suppliers that participate in Shared Savings (PBP) for episodes of care surrounding episode (90-days of RT services) occurs Program ACOs. As a policy matter, CMS has elected to impose a similar restriction on some participants chemotherapy administration to cancer completely during a 6-month OCM in other ACO initiatives through the participation patients. OCM is an episode payment episode, then the associated RO agreements for the various models. model that incentivizes care payments for RT services would be

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included in the OCM episode. In outpatient).64 BPCI Advanced is based incentivize ESRD facilities and addition, to account for the savings on a total cost of care approach with clinicians managing adult Medicare FFS generated by the RO Model discount certain MS–DRG exclusions. While beneficiaries with ESRD, referred to and withhold amounts, we would add there are no cancer episodes included in herein as Managing Clinicians, to work the RO Model’s discount and withhold the design of BPCI Advanced, a with their patients to achieve increased amounts to the total cost of the OCM beneficiary in a RO episode could be rates of home dialysis utilization and episode during OCM’s reconciliation treated by a provider or supplier that is kidney and kidney-pancreas process to ensure that there is no double participating in BPCI Advanced for one transplantation and, as a result, improve counting of savings and no double of the 37 clinical episodes included in or maintain the quality of care and payment of the withhold amounts BPCI Advanced. Since prospective reduce Medicare expenditures. Both of between the two models. episode payments made under the RO these modalities (home dialysis and In those cases where the RO Model Model would not be affected by BPCI transplantation) have support among episode would occur partially within an Advanced, BPCI Advanced would health care providers and patients as OCM episode and partially before or determine whether to account for RO preferable alternatives to in-center after the OCM episode, we propose to Model overlap in its reconciliation hemodialysis (HD), but the utilization allocate the RO Model payments for RT calculations, and CMS would provide rate of these services in the United services and the RO Model discount and further information to BPCI Advanced States (U.S.) has been below such rates withhold amounts to the OCM episode participants through an amendment to in other developed nations.65 In the on a prorated basis, based on the their participation agreement. proposed ETC Model, CMS would number of days of overlap. In this case, adjust Medicare payments under the 19. Decision Not To Include a Hardship the prorated portion of the payment ESRD Prospective Payment System Exemption under the RO Model, based on the (PPS) to ESRD facilities and payments number of days of overlap with the We do not believe that a hardship under the Medicare Physician Fee OCM episode, would be included in the exemption for RO participants under the Schedule (PFS) to Managing Clinicians OCM episode’s expenditures as well as Model is necessary, since in the Model’s paid the ESRD Monthly Capitation the prorated portion of the RO Model pricing methodology gives significant Payment (MCP) selected for discount and withhold, again based on weight to historical experience in participation in the Model. The the number of days of overlap with the determining the amounts for payment adjustments would include an OCM episode. Including the prorated participant-specific professional episode upward adjustment on home dialysis discount and withhold amounts would payments and participant-specific and home dialysis-related claims with ensure that there is no double counting technical episode payments. This is claim through dates during the initial of savings and no double payment of the particularly evident in PY1, where the three years of the ETC Model, that is, withhold amounts between the two proposed efficiency factor in section between January 1, 2020 and December models. III.C.6.e(2) is 0.90 for all RO 31, 2022. In addition, we would make In those cases where the RO Model participants. Accordingly, we are not an upward or downward performance episode occurs entirely within or proposing such an exemption in this adjustment on all dialysis claims and partially before or after the OCM proposed rule, and will not include dialysis-related claims with claim episode, for the purpose of calculating such an exemption in the final rule in through dates between July 1, 2021 and OCM episode costs, we would assume this rulemaking. June 30, 2026, depending on the rates of that all withholds are eventually paid to However, to the extent any home dialysis utilization and kidney the RO Participant under the RO Model, stakeholders disagree with our and kidney-pancreas transplantation and that there are no payments to assessment, we welcome public input among the beneficiaries attributed to recoup. We believe a process to allocate on whether a possible hardship these participating ESRD facilities and exact amounts paid to the participants exemption for RO participants under the Managing Clinicians. The ETC Model with different reconciliation timelines Model might be necessary or would test whether such payment between the two models would be appropriate, and if so, how it might be adjustments can reduce total program operationally complex. designed and structured while still expenditures and improve or maintain We intend to continue to review the allowing CMS to test the Model. We quality of care for Medicare potential overlap with OCM if the RO intend to use any input we receive on beneficiaries with ESRD. Model is finalized as proposed, this issue to consider whether a B. Background including whether there are hardship exemption might be implications for OCM’s prediction appropriate in subsequent rulemaking 1. Rationale for the Proposed ESRD model for setting risk-adjusted target for a future PY. Treatment Choices Model episode prices, which include receipt of Beneficiaries with ESRD are among RT services. Since prospective episode IV. End-Stage Renal Disease (ESRD) Treatment Choices Model the most medically fragile and high-cost payments made under the RO Model populations served by the Medicare would not be affected by OCM, OCM A. Introduction program. ESRD beneficiaries require would account for RO Model overlap in The proposed End-Stage Renal dialysis or kidney transplantation in its reconciliation calculations, and OCM Disease (ESRD) Treatment Choices order to survive, as their kidneys are no participants would be notified and (ETC) Model, referred to in this section longer able to perform life-sustaining provided with further information IV of the proposed rule as ‘‘the Model,’’ functions. In recent years, ESRD through OCM’s typical channels of would test whether adjusting the communication. current Medicare fee-for-service (FFS) 65 United States Renal Data System. 2018 USRDS annual data report: Epidemiology of kidney disease d. Bundled Payments for Care payments for dialysis services would in the United States. National Institutes of Health, Improvement (BPCI) Advanced National Institute of Diabetes and Digestive and 64 BPCI Advanced is testing a new Major joint replacement of the lower extremity Kidney Diseases, Bethesda, MD, 2018. Volume 2: is a multi-setting Clinical Episode category. Total End-stage Renal Disease (ESRD) in the United iteration of bundled payments for 37 Knee Arthroplasty (TKA) procedures can trigger States. Chapter 11: International Comparisons. clinical episodes (33 inpatient and 4 episodes in both inpatient and outpatient settings. Figures 11–15, 11–16.

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beneficiaries have accounted for about 1 a facility. In section IV.B.2 of this patients in the U.S. declined from 1988 percent of the Medicare population and proposed rule, we describe how current to 2012, with the number of home accounted for approximately 7 percent Medicare payment rules and a lack of dialysis patients increasing at a slower of total Medicare spending.66 beneficiary education result in a bias rate relative to the total number of all Beneficiaries with ESRD face the need toward in-center HD, which is often not dialysis patients. As cited in a U.S. for coordinating treatment for many preferred by patients or practitioners. In Government Accountability Office disease complications and proposing the ETC Model, we aim to (GAO) report, according to USRDS data, comorbidities, while experiencing high test whether new payment incentives approximately 16 percent of the 104,000 rates of hospital admissions and would lead to greater rates of home dialysis patients in the U.S. received readmissions and a mortality rate dialysis (both PD and HHD) and kidney home dialysis in 1988; however, by greatly exceeding that of the general transplantation. We provide evidence 2012, the rates of HHD and PD Medicare population. In addition, from published literature to support the utilization were 2 and 9 percent, studies during the past decade have projection that higher utilization rates respectively.74 reported higher mortality rates for for these specific interventions would Additionally, an annual analysis dialysis patients in the U.S. compared to likely reduce Medicare expenditures, performed by the USRDS in 2018 other countries.67 68 while preserving or enhancing the compared the rates of dialysis ESRD is a uniquely burdensome quality of care for beneficiaries and, at modalities for prevalent dialysis condition; with uncertain survival, the same time, enhance beneficiary patients in the U.S. to 63 selected patient experience represents a critical choice, independence, and quality of countries or regions around the world. dimension for assessing treatment. The life. In 2016, the U.S. ranked 27th in the substantially higher expenditures and percentage of beneficiaries that were a. Home Dialysis hospitalization rates for ESRD dialyzing at home (12 percent). For beneficiaries compared to the overall There are two general types of example, the U.S. rate of home dialysis Medicare population, and higher dialysis: HD, in which an artificial filter is significantly below those of Hong mortality than in other countries outside of the body is used to clean the Kong (74 percent), New Zealand (47 indicate a population with poor clinical blood; and PD, in which the patient’s percent), Australia (28 percent), and outcomes and potentially avoidable peritoneum, covering the abdominal Canada (25 percent).75 expenditures. We anticipate that the organs, is used as the dialysis A 2011 report on home dialysis in the proposed ETC Model would maintain or membrane. HD is conducted at an ESRD U.S. related the relatively low rate of improve the quality of care for ESRD facility, usually 3 times a week, or at a home dialysis in this country to factors beneficiaries and reduce expenditures patient’s home, often at a greater that included educational barriers, the for the Medicare program by creating frequency. PD most commonly occurs at monthly visit requirement for the MCP incentives for health care providers to the patient’s home. (Although PD can be under the PFS, the need for home care assist beneficiaries, together with their furnished within an ESRD facility, it is partner support, as well as philosophies families and caregivers, to choose the very rare. In providing background and business practices of dialysis optimal renal replacement modality for information for the proposed ETC providers, such as staffing allocations, the beneficiary. Model, we consider PD to be exclusively lack of independence for home dialysis The majority of ESRD patients a home modality.) Whether a patient clinics, and business-oriented receiving dialysis receive HD in an selects HD or PD may depend on a restrictions that lead to inefficient ESRD facility. At the end of 2016, 63.1 number of factors, such as patient supply distribution. The report percent of all prevalent ESRD patients— education before dialysis initiation, recommended consolidated, meaning patients already diagnosed social and care partner support, collaborative efforts to enhance patient education among nephrology practices, with ESRD—in the U.S. were receiving socioeconomic factors, and patient dialysis provider organizations, hospital HD, 7.0 percent were being treated with perceptions and preference.71 72 systems and kidney-related peritoneal dialysis (PD), and 29.6 When Medicare began coverage for organizations, as well as additional percent had a functioning kidney individuals on the basis of ESRD in educational opportunities and training transplant.69 Among HD cases, 98.0 1973, more than 40 percent of dialysis for nephrologists and dialysis staff. With percent used in-center HD, and 2.0 patients in the U.S. were on HHD. More regard to CMS’s requirement starting in percent used home hemodialysis favorable reimbursement for outpatient 2011 that the physician or non- (HHD).70 PD is rarely conducted within dialysis and the introduction in the 1970s of continuous ambulatory physician practitioner furnish at least one in-person patient visit per month 66 Kirchoff SM. Medicare Coverage of End-Stage peritoneal dialysis, which required less Renal Disease (ESRD). Congressional Research intensive training, contributed to a for home dialysis MCP services, the Service. August 16, 2018. p. 1. relative decline in HHD utilization.73 report noted that CMS allows discretion 67 Foley RN, Hakim RM. Why Is the Mortality of Overall, the proportion of home dialysis to Medicare contractors to allow Dialysis Patients in the United States Much Higher payment without a visit so long as there than the Rest of the World? Journal of the American Society of Nephrology. 2009; 20(7):1432–1435. Modalities. https://www.usrds.org/2018/view/v2_ is evidence for the provision of services doi:https://doi.org/10.1681/ASN.2009030282. 01.aspx. throughout the month. Nevertheless, the 68 Robinson B, Zhang J, Morgenstern H, et al. 71 Stack AG. Determinants of Modality Selection report concluded that notwithstanding Worldwide, mortality is a high risk soon after among Incident US Dialysis Patients: Results from this allowance the stated policy might initiation of hemodialysis. Kidney a National Study. Journal of the American Society potentially be a disincentive for International.2014;85(1):158–165. Doi:10.1038/ of Nephrology. 2002; 13: 1279–1287. Doi 1046– ki.2013.252. 6673/1305–1279. physicians to promote home dialysis. 69 United States Renal Data System, Annual Data 72 Miskulin DC, et al. Comorbidity and Other Report, 2018. Volume 2. Chapter 1: Incidence, Factors Associated With Modality Selection in 74 Unites States Government Accountability Prevalence, Patient Characteristics, and Treatment Incident Dialysis Patients: The CHOICE Study. Office. End Stage Renal Disease: Medicare Payment Modalities. https://www.usrds.org/2018/view/v2_ American Journal of Kidney Diseases. 2002; 39(2): Refinements Could Promote Increased Use of Home 01.aspx. 324–336. Doi 10.1053/ajkd.2002.30552. Dialysis (GAO–16–125). October 2015. 70 United States Renal Data System, Annual Data 73 Blagg CR. A Brief History of Home 75 United States Renal Data System, Annual Data Report, 2018. Volume 2. Chapter 1: Incidence, Hemodialysis. Annals in Renal Replacement Report, 2018. Volume 2, Chapter 11: International Prevalence, Patient Characteristics, and Treatment Therapy. 1996; 3: 99–105. Comparisons. Figure F11.12.

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The report further commented that the maintenance dialysis were presented comparative cost and effectiveness of low rate of home dialysis in the U.S. with PD as an option, and only 12 different dialysis modalities assess PD may result in part from patients’ percent of patients were presented with versus HD. We believe that since the inability to perform self-care, and HHD as an option.80 As shown by a extent of in-center PD is negligible, and suggested providing support for home national pre-ESRD education initiative, only approximately 2 percent of HD care partners. With respect to dialysis pre-dialysis education results in a 2- to occurs at home, these studies are providers’ business practices and 3- fold increase in the rate of patients suitable for drawing conclusions philosophies, the report notes that initiating home dialysis compared with regarding home versus in-center dialysis providers differ in many ways the U.S. home dialysis rate.81 Another dialysis.) However, research on cost and have different experiences that study reported 42 percent of patients differences between in-center dialysis deserve attention and consideration preferring PD when the option was and home dialysis is limited to with regard to potentially posing a presented to them.82 comparing costs for patients who barrier to the provision of home Recent studies show substantial currently dialyze at home to those who dialysis.76 support among nephrologists and do not. As previously discussed, there The high rate of incident dialysis patients for dialysis treatment at are currently barriers to dialyzing at patients beginning dialysis through in- home.83 84 85 86 87 We believe that home that may result in selection bias. center HD in the U.S. is driven by a increasing rates of home dialysis has the Put another way, beneficiaries who variety of factors including ease of potential to not only reduce Medicare currently dialyze at home may be initiation, physician experience and expenditures, but also to preserve or different in some way from beneficiaries training, misinformation around other enhance the quality of care for ESRD who dialyze in-center that is otherwise modalities, inadequate education for beneficiaries. the cause of the observed difference in CKD beneficiaries, built-up capacity at Research suggests that dialyzing at overall medical expenditures. Patients ESRD facilities, and a lack of home is associated with lower overall may differ in terms of age, gender, race, infrastructure to support home medical expenditures than dialyzing in- and clinical issues such as presence of dialysis.77 (Provision of home dialysis center. Key factors that may be related diabetes and origin of ESRD.93 Despite requires a system of distribution of to lower expenditures include selection bias present in existing supplies to patients, as well as potentially lower rates of infection research, we expect that increasing rates allocation of staff and space within associated with dialysis treatment, of home dialysis will likely decrease facilities for education, training, clinic fewer hospitalizations, cost differentials Medicare expenditures for ESRD visits, and supervision). One study between PD and HD services and beneficiaries, and this is something we indicated that patients’ perceived supplies, and lower operating costs for would assess as part of our evaluation knowledge about various ESRD dialysis providers for providing home of the ETC Model, if finalized. therapies was correlated with their dialysis.88 89 90 91 92 (Most studies on the In addition, current research on understanding of the advantages and patients in the U.S. and Canada disadvantages of the available treatment 80 Mehrotra R, Marsh D, Vonesh E, Peters V, indicates similar, or better, patient options.78 Researchers have reported Nissenson A. Patient education and access of ESRD survival outcomes for PD compared to that greater support, training, and patients to renal replacement therapies beyond in- HD.94 95 96 (As previously noted, most center hemodialysis. Kidney International. 2005; education to nephrologists, other 68(1):378–390. clinicians, and patients would increase 81 Lacson E, Wang W, DeVries C, Leste K, Hakim review of full economic evaluations. Nephrology. the use of both HHD and PD. A RM, Lazarus M, Pulliam J. Effects of a Nationwide 2014; 19: 459–470 doi: 10.1111/nep.12269. 89 prospective evaluation of dialysis Predialysis Educational Program on Modality Walker R, Howard K, Morton R. Home Choice, Vascular Access, and Patient Outcomes. hemodialysis: A comprehensive review of patient- modality eligibility among patients with American Journal of Kidney Diseases. 2011; 58(2): centered and economic considerations. chronic kidney disease (CKD) stages III 235–242.doi:10.1053/j.ajkd.2011.04.015. ClinicoEconomics and Outcomes Research. 2017; 9: to V enrolled in a North American 82 Maaroufi A, Fafin C, Mougel S, Favre G, Seitz- 149–161. 90 cohort study showed that as many as 85 Polski P, Jeribi A, Vido S, Dewismi C, Albano L, Howard K, Salkeld G, White S, McDonald S, Chadban S, Craig J, Cass A. The cost effectiveness percent were medically eligible for Esnault V, Moranne O. Patient preferences regarding choice of end-stage renal disease of increasing kidney transplantation and home- 79 PD. However, in one study, only one- treatment options. American Journal of Nephrology. based dialysis. Nephrology. 2009; 14: 123–132 doi: third of ESRD patients beginning 2013; 37(4): 359–369. doi: 1159/000348822. 10.1111/j.1440–1797.2008.01073.x. 91 83 Rivara MB, Mehrotra R. The Changing Quinn R, Ravani P, Zhang X, Garg A, Blake P, Austin P, Zacharias JM, Johnson JF, Padeya S, 76 Landscape of Home Dialysis in the United States. Golper TA, Saxena AB, Piraino B, Teitelbaum, Verreli M, Oliver M. Impact of Modality Choice on Current Opinion in Nephrology and I, Burkart, J, Finkelstein FO, Abu-Alfa A. Systematic Rates of Hospitalization in Patients Eligible for Both Hypertension.2014; 23(6):586–591.doi:10.1097/ Barriers to the Effective Delivery of Home Dialysis Peritoneal Dialysis and Hemodialysis. Peritoneal MNH0000000000000066. in the United States: A Report from the Public Dialysis International. 2014; 34(1): 41–48 doi: 84 Policy/Advocacy Committee of the North American Mehrotra R, Chiu YW, Kalantar-Zadeh K, 10.3447/pdi.2012.00257. Chapter of the International Society for Peritoneal Bargman J, Vonesh E. Similar Outcomes With 92 Sinnakirouchenan R, Holley, J. Peritoneal Dialysis. American Journal of Kidney Diseases. Hemodialysis and Peritoneal Dialysis in Patients Dialysis Versus Hemodialysis: Risks, Benefits, and 2011; 58(6): 879–885.doi:10.1053/j.ajkd.2011.06.028 With End-Stage Renal Disease. Archives of Internal Access Issues. Advances in Chronic Kidney 77 Ghaffarri A, Kalantar-Zadeh K, Lee J, Maddux Medicine. 2011; 171(2): 110–118. Doi:10.1001/ Disease. 2011; 18(6): 428–432. doi: 10.1053/ F, Moran J, Nissenson A. PD First: Peritoneal archinternmed.2010.352. j.ackd.2011.09.001. 85 Dialysis as the Default Transition to Dialysis Ghaffari et al. 2013. 93 United States Renal Data System, Annual Data Therapy. Seminars in Dialysis. 2013; 26(6): 706– 86 Ledebo I, Ronco C. The best dialysis therapy? Report, 2018. Volume 2, Chapter 1: Incidence, 713. doi: 10.1111/sdi.12125. Results from an international survey among Prevalence, Patient Characteristics, and Treatment 78 Finkelstein FO, Story K, Firanek C, Barr P, et nephrology professionals. Nephrology Dialysis Modalities. Table 1. al. Perceived knowledge among patients cared for Transplantation.2008;6:403–408.doi:10.1093/ 94 Wong B, Ravani P, Oliver MJ, Holroyd-Leduc by nephrologists about chronic kidney disease and ndtplus/sfn148. J, Venturato L, Garg AX, Quinn RR. Comparison of end-stage renal disease therapies. Kidney 87 Schiller B, Neitzer A, Doss S. Perceptions about Patient Survival Between Hemodialysis and International 2008; 9: 1178–1184. https://doi.org/ renal replacement therapy among nephrology Peritoneal Dialysis Among Patients Eligible for Both 10.1038/ki.2008.376. professionals. Nephrology News & Issues. Modalities. American Journal of Kidney Diseases. 79 Mendelssohn DC. Mujais SK, Soroka, SD, et al. September 2010; 36–44. 2018; 71(3) 344–351. doi:10.1053/ A prospective evaluation of renal replacement 88 Walker R, Marshall MR, Morton RL, McFarlane j.ajkd.2017.08.028. therapy modality eligibility. Nephrology Dialysis P, Howard K. The cost-effectiveness of 95 Kumar VA, Sidell MA, Jones JP, Vonesh EF. Transplantation. 2009; 24(2): 555–561. doi: https:// contemporary home haemodialysis modalities Survival of propensity matched incident peritoneal doi.org/10/1093/ndt/gfn484. compared with facility haemodialysis: A systematic Continued

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research on the comparative greater detail throughout this section IV transplant recipients, there are a lower effectiveness of different dialysis of this proposed rule, one of the aims of rates of hospitalizations, emergency modalities compares PD to HD, but we the proposed ETC Model is to test department visits, and readmissions.112 believe these studies are suitable for whether new payment incentives would While comparisons between patients on comparing home to in-center dialysis, lead to greater rates of home dialysis. dialysis and those with functioning given that in-center PD is negligible and transplants rely on observational data, b. Kidney Transplants only approximately 2 percent of HD is due to the ethical concerns with conducted at home.) The USRDS shows A kidney transplant involves conducting clinical trials, the data lower adjusted all-cause mortality rates surgically transplanting one healthy nonetheless suggest better outcomes for for 2013 through 2016 for PD compared kidney from a living or deceased donor. ESRD patients that receive transplants. to HD.97 Therefore, we believe increased A kidney-pancreas transplant involves Notwithstanding these outcomes, only rates of PD associated with increased simultaneously transplanting both a 29.6 percent of prevalent ESRD patients rates of home dialysis prompted by the kidney and a pancreas, for patients who in the U.S. had a functioning kidney proposed Model would at least have kidney failure related to type 1 transplant and only 2.8 percent of maintain, and may improve, quality of diabetes mellitus. While the kidney in a incident ESRD patients—meaning care provided to ESRD beneficiaries. kidney-pancreas transplant may come patients new to ESRD—received a pre- While studies from several nations from a living or deceased donor, the emptive kidney transplant in 2016.113 A observe that the survival advantage for pancreas can only come from a deceased pre-emptive transplant is a kidney PD may be attenuated following the donor. Candidates for kidney transplant transplant that occurs before the patient early years of dialysis treatment (1 to 3 undergo a rigorous evaluation by a requires dialysis. These rates are years), and also that advanced age and transplant center prior to placement on substantially below those of other certain comorbidities among patients a waitlist, and once placed on the developed nations. The U.S. was ranked are related to less favorable outcomes waitlist, potential recipients must 39th of 61 reporting countries in kidney for PD, a component of the Model’s maintain active status on the waitlist. transplants per 1,000 dialysis patients in evaluation would be to assess the The United Network for Organ Sharing 2016, with 39 transplants per 1,000 applicability of these findings to the (UNOS) maintains the waitlist for and dialysis patients in 2016.114 While the U.S. population and Medicare conducts matching of deceased donor relatively low rate of transplantation in beneficiaries, specifically if there is organs. ESRD beneficiaries already on the U.S. may partly reflect the high sufficient statistical power to detect dialysis continue to receive regular numbers of dialysis patients and meaningful variation.98 99 100 101 102 103 104 dialysis treatments while waiting for an differences in the relative prevalence Patient benefits of HHD and PD also can appropriate organ. and incidence of ESRD, there are other include better quality of life and greater A systematic review of studies likely contributing causes, such as independence.105 106 107 As described in worldwide finds significantly lower differences in health care systems, the mortality and risk of cardiovascular infrastructure supporting and hemodialysis patients in a United States health events associated with kidney transplantation, and cultural factors.115 care system. Kidney International. 2014; 86: 1016– transplantation compared with The main barrier to kidney transplant 1022. doi:10.1038/ki.2014.224. 108 96 maintenance dialysis. Additionally, is the supply of available organs. Mehrotra et al. 2011. this review finds that beneficiaries who 97 United States Renal Data System. Annual Data Medicare is undertaking regulatory Report, 2018. Volume 2, Chapter 5: Mortality. receive transplants experience a better efforts to increase organ supply, Figure 5.1. Mortality rates were adjusted for age, quality of life than treatment with discussed in section IV.B.3.a of this sex, race, ethnicity, primary diagnosis and vintage. chronic dialysis.109 proposed rule. Further, we believe there 98 Li KP, Chow KM. Peritoneal Dialysis—First Per-beneficiary-per-year Medicare Policy Made Successful: Perspectives and Actions. are a number of things ESRD facilities American Journal of Kidney Diseases. 2013; 62(5): expenditures for beneficiaries receiving and Managing Clinicians can do to 993–1005. doi: http://dx/doi.org/10.1053/ kidney or kidney-pancreas transplants assist their beneficiaries in securing a j.ajkd.2013.03.038. are often substantially lower than for transplant. Access to kidney 99 Yeates K, Zhu N, Vonesh E, Trpeski L, Blake those on dialysis.110 The average transplantation can be improved by P, Fenton S. Hemodialysis and peritoneal dialysis are associated with similar outcomes for end-stage dialysis patient is admitted to the increasing referrals to the transplant renal disease treatment in Canada. Nephrology hospital nearly twice a year, often as a waiting list, increasing rates of deceased Dialysis Transplantation. 2012; 27(9): 3568–3575. result of infection, and approximately and living kidney donation, expanding doi: https://doi.org/10.1093/ndt/gfr/674. 35.4 percent of dialysis patients who are the pools of potential donors and 100 Chiu YW, Jiwakanon S, Lukowsky L, Duong U, discharged are re-hospitalized within 30 Kalantar-Zadeh, Mehrotra R. An Update on the recipients, and reducing the likelihood 111 Comparisons of Mortality Outcomes of days of being discharged. Among Hemodialysis and Peritoneal Dialysis Patients. Hospitalizations, Readmissions, Emergency Seminars in Nephrology. 2011; 31(2): 152–158. 107 Juergensen E, Wuerth D, Finkelstein SH et al., Department Visits, and Observation Stays. Tables Doi:10.1016/j.semnephrol.2011.01.004. Hemodialysis and Peritoneal Dialysis: Patients’ F4–1, F4–8. 101 Mehrotra et al. 2011. Assessments of Their Satisfaction with Therapy and 112 United States Renal Data System. Annual Data 102 Sinnakirouchenan R, Holley JL. 2011. the Impact of the Therapy on their Lies. Clinical Report, 2018: Volume 2, Chapter 4: 103 Quinn RR, Hux JE, Oliver MJ, Austin, PC, Journal of American Society of Nephrology. 2006; Hospitalizations, Readmissions, Emergency Tonelli M, Laupacis A. Selection Bias Explains 1(6): 1191–1196. DOI: https://doi.org/10.2215/ Department Visits, and Observation Stays. Tables Apparent Differential Mortality between Dialysis CJN.01220406. F4.1, F4.8, and F4.14. Modalities. Journal of the American Society of 108 Tonelli M, Weibe N, Knoll G, Bello A, Browne 113 United States Renal Data System. Annual Data Nephrology. 2011; 22(8) 1534–1542. doi: 10.1681/ S. Jadhav D, Klarenbach S, Gill J. Systematic Report, 2018; Volume 2. Chapter 1: Incidence, ASN.2010121232. Review: Kidney Transplantation Compared with Prevalence, Patient Characteristics, and Treatment 104 Weinhandl ED, Foley RN, Gilbertson DT, Dialysis in Clinically Relevant Outcomes. American Modalities. https://www.usrds.org/2018/view/v2_ Arneson TJ, Snyder JJ, Collins AJ. Propensity- Journal of Transplantation. 2011; 11(10). doi: 01.aspx. Matched Mortality Comparison of Incident https://doi.org/10.1111/j.1600–6143.2011.03686.x. 114 United States Renal Data System. Annual Data Hemodialysis and Peritoneal Dialysis Patients. 109 Tonelli, M. et al. 2011. Report, 2018. Volume 2. Chapter 11. International Journal of the American Society of Nephrology. 110 United States Renal Data System. Annual Data Comparisons. Figure 11.16. 2010; 21(3): 499–506. doi: 10.1681/ Report, 2018. Volume 2. Chapter 9: Healthcare 115 United States Renal Data System. Annual Data ASN.2009060635: 10.1681/ASN.2009060635. expenditures for Persons with ESRD. Figure F9.8. Report, 2018: Volume 2. Chapter 11. International 105 Ghaffari et al. 2013. 111 United States Renal Data System. Annual Data Comparisons. https://www.usrds.org/2018/view/v2_ 106 Rivara and Mehrotra. 2014. Report, 2018; Volume 2, Chapter 4: 11.aspx.

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that potentially viable organs are month, a post-transplant beneficiary payments on claims for dialysis and discarded.116 We anticipate that requires fewer visits per year, and these certain dialysis-related services with Managing Clinicians and ESRD facilities visits are of a lower intensity. As through dates from January 1, 2020 selected for participation in the described in greater detail throughout through June 30, 2026, with the goal of proposed ETC Model would address this section IV of this proposed rule, one reducing Medicare spending, preserving these areas of improvement through of the aims of the proposed ETC Model or enhancing quality of care for various strategies in order to improve is to test whether new payment beneficiaries, and increasing beneficiary their rates of transplantation. These incentives would lead to greater rates of choice regarding ESRD treatment strategies could include educating kidney transplantation. modality. beneficiaries about transplantation, c. Addressing Care Deficits Through the 2. The Medicare ESRD Program coordinating care for beneficiaries as ETC Model they progress through the transplant In this section, we describe current waitlist process, and assisting Considering patient and clinician Medicare payment rules and how they beneficiaries and potential donors with support for home dialysis and kidney may create both positive and negative issues surrounding living donation, transplant for ESRD patients, along with incentives for the provision of home including support for paired donations evidence that use of these treatment dialysis services and kidney transplants. modalities could be increased with and donor chains. In paired donations a. History of the Medicare ESRD education, we propose to implement the and donor chains, willing donors who Program are incompatible with their intended ETC Model to test whether adjusting recipient can donate to other candidates Medicare payments to ESRD facilities Section 299I of the Social Security on the transplant waitlist in return for under the ESRD PPS and to Managing Amendments of 1972 (Pub. L. 92–603) a donation from another willing donor Clinicians under the PFS would extended Medicare coverage to who is compatible with their intended increase rates of home dialysis, both individuals regardless of age who have recipient.117 HHD and PD, and kidney and kidney- permanent kidney failure, or ESRD, After increasing during the 1990s, the pancreas transplantation. requiring either dialysis or kidney volume of simultaneous pancreas and We propose that the ETC Model transplantation to sustain life, and who kidney transplants has either remained would include two types of payment meet certain other eligibility stable or declined slightly since the adjustments: The Home Dialysis requirements. Individuals who become early 2000s. The reason for this decline Payment Adjustment (HDPA), and the eligible for Medicare on the basis of is not clear, but is likely to be Performance Payment Adjustment ESRD are eligible for all Medicare- multifactorial, possibly including a (PPA). The HDPA would be a positive covered items and services, not just decrease in patients being placed on the payment adjustment on home dialysis those related to ESRD. Subsequently, waiting list for this procedure, more and home dialysis-related claims during the ESRD Amendments of 1978 (Pub. L. stringent donor selection, and greater the initial three years of the Model, to 95–292) amended Title XVIII of the scrutiny of transplant center provide an up-front incentive for ETC Social Security Act (the Act) by adding outcomes.118 Participants to provide additional section 1881. Under current Medicare payment support to beneficiaries choosing to Section 1881 of the Act establishes systems, an ESRD beneficiary receiving dialyze at home. The PPA would be a Medicare payment for services a kidney transplant represents a loss of positive or negative payment furnished to individuals who have been revenue to the ESRD facility and, to a adjustment, which would increase over determined to have ESRD, including lesser extent, the Managing Clinician. time, on dialysis and dialysis-related payments for self-care home dialysis After a successful transplant occurs, the claims, both home and in-center, based support services furnished by a provider ESRD facility no longer has a care on the ETC Participant’s home dialysis of services or renal dialysis facility, relationship with the beneficiary, as the rates and transplant rates during a home dialysis supplies and equipment, beneficiary no longer requires Measurement Year in comparison to and institutional dialysis services and maintenance dialysis. While the achievement and improvement supplies. Section 1881(c)(6) of the Act Managing Clinician may continue to benchmarks, with the aim of increasing states: It is the intent of the Congress have a care relationship with the the percent of ESRD beneficiaries either that the maximum practical number of beneficiary post-transplant, payment for having received a kidney transplant or patients who are medically, socially, physicians’ services related to receiving home dialysis over the course and psychologically suitable candidates maintaining the health of the of the ETC Model. The magnitude of the for home dialysis or transplantation transplanted kidney is lower than the HDPA would decrease as the magnitude should be so treated. This provision also MCP for managing dialysis. Whereas a of the PPA increases, to shift from a directs the Secretary of HHS to consult Managing Clinician sees a beneficiary process-based incentive approach (the with appropriate professional and on dialysis and bills for the MCP each HDPA) to an outcomes-based incentive network organizations and consider approach (the PPA). available evidence relating to 116 Serur D, Bingaman A, Smith B. Kidney The proposed payment adjustments developments in research, treatment Transplantation 2017 Breaking Down Barriers and under the ETC Model would apply to all methods, and technology for home Building Bridges. American Society of Nephrology: Medicare-certified ESRD facilities and Kidney News Online. 2017; 9(4): kidneynews.org/ dialysis and transplantation. kidney-news/practice-pointers/kidney- Managing Clinicians enrolled in Prior to 2011 and the implementation transplantation-2017-breaking-down-barriers-and- Medicare located within selected of the ESRD PPS, Medicare had a building-bridges. geographic areas. While we propose to composite payment system for the costs 117 Segev D, Gentry S, Warren D. Kidney Paired apply the HDPA to all ETC Participants, incurred by ESRD facilities furnishing Donation and Optimizing the Use of Live Donor Organs. JAMA. 2005;293(15):1883–1890. the PPA would not apply to certain outpatient maintenance dialysis, doi:10.1001/jama.293.15.1883. ESRD facilities and Managing Clinicians including some routinely provided 118 Redfield RR, Scalea JR, Odoricio JS. managing low volumes of adult ESRD drugs, laboratory tests, and supplies, Simultaneous pancreas and kidney transplantation: Medicare beneficiaries. One or both of whether the services were furnished in Current trends and future directions. Current Opinion in Organ Transplantation. 2015; 20(1): 94– the payment adjustments under the a facility or at home. (For a discussion 102. Doi:10.1097/MOT.0000000000000146. proposed ETC Model would apply to of the composite payment system,

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please see 75 FR 49032). Under this outpatient facilities, including certain of PD) (75 FR 49057, 49059, 49064). The methodology, prior to 2009, CMS dialysis treatment supplies and CY 2011 ESRD PPS final rule also differentiated between hospital-based medications, home dialysis services, finalized a wage-adjusted add-on per and independent facilities for purposes support and equipment, and doctor’s treatment adjustment for home and self- of setting the payment rates. (Effective services during a kidney transplant. dialysis training under 42 CFR January 1, 2009, CMS discontinued the Costs for medical care for a kidney 413.235(c), as CMS recognized that the policy of separate payment rates based donor are covered under either Part A ESRD PPS base rate alone does not on this distinction 75 FR 49034). or B, depending on the service. To date, account for the staffing costs associated However, the same rate applied Medicare Part C has been available to with one-on-one focused home dialysis ESRD beneficiaries only in limited regardless of whether the dialysis was training treatments furnished by a furnished in a facility or at a circumstances, such as when an registered nurse (75 FR 49064). CMS beneficiary’s home. (75 FR 49058) The individual already was enrolled in a system was relatively comprehensive Medicare Advantage (MA) plan at the noted, however, that because the costs with respect to the renal dialysis time of ESRD diagnosis; however, as associated with the onset of dialysis services included as part of the required under section 17006 of the 21st adjustment and the training add-on composite payment, but over time a Century Cures Act, ESRD beneficiaries adjustment overlap, ESRD facilities substantial portion of expenditures for will be allowed to enroll in MA plans would not receive the home dialysis renal dialysis services such as drugs and starting with 2021. Medicare Part D training adjustment in addition to the biologicals were not included under the generally provides coverage for add-on payment under the ESRD PPS composite payment and paid separately outpatient prescription drugs not for the first 4 months of dialysis for a in accordance with the respective fee covered under Part B, including certain Medicare patient (75 FR 49063, 49094). schedules or other payment renal dialysis drugs with only an oral ESRD PPS payment requirements are methodologies (75 FR 49032). With the form of administration (oral-only drugs), set forth in 42 CFR part 413, subpart H. enactment of the Medicare and prescription medications for related Since the implementation of the ESRD Improvements for Patients and conditions. PPS, CMS has published annual rules to Providers Act of 2008 (MIPPA) (Pub. L. (1) The ESRD PPS Under Medicare make routine updates, policy changes, 110–275), the Secretary was required to Part B implement a payment system under and clarifications. Payment to ESRD which a single payment is made for Under the ESRD PPS, a single per facilities under the ESRD PPS for a renal dialysis services in lieu of any treatment payment is made to an ESRD calendar year may also be reduced by other payment. facility for all of the renal dialysis up to two percent based on their In 2008, CMS issued a final rule services and items defined in section performance under the ESRD QIP, entitled ‘‘Medicare and Medicaid 1881(b)(14)(B) of the Act and furnished which is authorized by section 1881(h) Programs; Conditions for Coverage for to beneficiaries for the treatment of of the Act. Section 1881(h) of the Act End-Stage Renal Disease Facilities,’’ ESRD in a facility or in a patient’s home. requires the Secretary to select which was the first comprehensive The ESRD PPS includes patient-level measures, establish performance revision since the outset of the Medicare adjustments for case mix, facility-level standards that apply to the measures, ESRD program in the 1970s. The adjustments for wage levels, low- and develop a methodology for Conditions for Coverage (CfC) volume facilities and rural facilities, assessing the total performance for each established by this final rule include and, when applicable, a training add-on renal dialysis facility based on the separate, detailed provisions applicable for home and self-dialysis modalities, an performance standards established with to home dialysis services, setting additional payment for high cost respect to the measures for a outliers due to unusual variations in the substantive standards for treatment at performance period. CMS uses notice type or amount of medically necessary home to ensure that the quality of care and comment rulemaking to make is equivalent to that for in-center care, and a transitional drug add-on substantive updates to the ESRD PPS patients. (73 FR 20369, 20409, April 15, payment adjustment (TDAPA). Under and ESRD QIP program requirements. 2008). section 1881(b)(14)(F) of the Act, the On January 1, 2011, CMS ESRD PPS payment amounts are (2) The MCP implemented the ESRD PPS, a case-mix increased annually by an ESRD market adjusted, bundled PPS for renal dialysis basket increase factor, reduced by the Medicare pays for routine services furnished by ESRD facilities as productivity adjustment described in professional services relating to dialysis required by section 1881(b)(14) of the section 1886(b)(3)(B)(xi)(II) of the Act. care directly to a billing physician or Act, as added by section 153(b) of In implementing the ESRD PPS, we non-physician practitioner. When MIPPA. The ESRD PPS is discussed in have sought to create incentives for Medicare pays the physician or detail in the following section. providers and suppliers to offer home practitioner separately for routine dialysis instead of just dialysis at a dialysis-related physicians’ services b. Current Medicare Coverage of and facility. In the CY 2011 ESRD PPS final Payment for ESRD Services furnished to a dialysis patient, the rule, we noted that in determining payment is made under the Medicare The Medicare program covers a range payment under the ESRD PPS, we took physician fee schedule using the MCP of services and items associated with into account all costs necessary to method as specified in 42 CFR 414.314. ESRD treatment. Medicare Part A furnish home dialysis treatments generally includes coverage of inpatient including staff, supplies, and The per-beneficiary per-month MCP is dialysis for patients admitted to a equipment. In that rule, we described for all routine physicians’ services hospital or skilled nursing facility for that Medicare would continue to pay, related to the patient’s renal condition. special care, as well as inpatient on a per treatment basis, the same base Whereas the MCP for patients dialyzing services for covered kidney transplants. rate for both in-facility and home in-center varies based on the number of Medicare Part B generally includes dialysis, as well as for all dialysis in-person visits the physician has with coverage of renal dialysis services treatment modalities furnished by an the patient during the month, the MCP furnished by Medicare-certified ESRD facility (HD and the various forms for patients dialyzing at home is the

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same regardless of the number of in- equipment and supplies to multiple each patient who has completed home person visits.119 ESRD facilities and be able to negotiate dialysis training under the physician’s competitive prices with ESRD supervision.123 (3) The Kidney Disease Education equipment and supply manufacturers The GAO report concluded that Benefit (75 FR 49060). Nevertheless, we stated interviews with stakeholders indicated In addition to establishing the ESRD that we would monitor utilization of potential for further growth, noting that PPS, the MIPPA, in section 152(b), home dialysis under the ESRD PPS (75 the number and percentage of patients amended section 1861(s)(2) of the Act FR 49057, 49060). choosing home dialysis had increased in by adding a new subparagraph (EE) A May 2015 report from GAO the recent years. The report stated that ‘‘kidney disease education services’’ as examined the incentives for home Medicare payments to facilities and a Medicare-covered benefit under Part B dialysis associated with Medicare physicians would need to be consistent for beneficiaries with Stage 4 CKD. payments to ESRD facilities and with the goal of encouraging home Medicare currently covers up to 6 1- physicians. Citing the USRDS, GAO dialysis when appropriate. A specific hour sessions of KDE services, found a decrease in the percentage of recommendation was to examine addressing the choice of treatment (such home dialysis patients as a percentage Medicare policies regarding monthly as in-center HD, home dialysis, or of all dialysis patients between 1988 Medicare payments to physicians and kidney transplant) and the management and 2008, but then a slight increase to revise them if necessary to encourage of comorbidities, among other topics (74 11 percent in 2012.121 According to physicians to prescribe home dialysis FR 61737, 61894). GAO, the more recent increase in use of for patients for whom it is However, utilization of KDE services home dialysis was also reflected in CMS appropriate.124 has been low. Citing the USRDS, GAO data for adult Medicare dialysis In the CY 2017 ESRD PPS final rule, reported that less than 2 percent of patients, showing an increase from 8 CMS finalized an increase to the home eligible Medicare beneficiaries used the percent using home dialysis in January and self-dialysis training add-on KDE benefit in 2010 and 2011, the first 2010 to about 10 percent as of March payment adjustment (81 FR 77856), to 2 years it was available, and that use of 2015. provide an increase in payment to ESRD the benefit has decreased since then.120 Although this increase was generally facilities for training beneficiaries to According to GAO, stakeholders have concurrent with the phase-in of the dialyze at home. attributed this low usage to the statutory ESRD PPS, the GAO report identified restrictions on which practitioners can factors that might undermine incentives 3. CMS Efforts To Support Modality provide this service, and also the to encourage home dialysis. According Choice limitation of eligibility to the specific to interviews with stakeholders, While CMS has taken steps in the past category of Stage 4 CKD patients. These facilities’ costs for increasing provision to support modality choice, the deficits restrictions are specified in section of in-center HD may be lower than for in care previously described—low rates 1861(ggg)(1) and (2) of the Act. A either HHD or PD. Although the average of home dialysis and kidney ‘‘qualified person’’ is a physician, cost of an in-center HD treatment is transplantation—remain. The proposed physician assistant, or nurse typically higher than the average cost of ETC Model is consistent with several practitioner. Also, a provider of services a PD treatment, ESRD facilities may be different recent actions to support the located in a rural area is eligible as a able to add an in-center patient without goal of modality choice for ESRD ‘‘qualified person’’ to provide the incurring the cost of an additional beneficiaries, which are described in service. GAO cited literature dialysis machine because each machine this proposed rule. emphasizing the importance of pre- can be used by 6 to 8 patients. In dialysis education in helping patients to contrast, when adding a home dialysis a. Regulatory Efforts make informed treatment decisions, and patient, facilities generally incur costs On September 20, 2018, CMS indicating that patients who have for additional equipment specific to published in the Federal Register a received such education might be more individual patients.122 proposed rule entitled ‘‘Medicare and likely to choose home dialysis. Similarly, GAO received comments Medicaid Programs; Regulatory c. Impacts of Medicare Payment Rules from physicians and physician Provisions to Promote Program on Home Dialysis organizations that Medicare payment Efficiency, Transparency, and Burden In the CY 2011 ESRD PPS final rule, may lead to a disincentive to prescribe Reduction.’’ (83 FR 47686). The we acknowledged concerns from home dialysis, because management of proposed rule would, among other commenters that the proposed ESRD a home dialysis patient often occurs in things, remove the requirements at 42 PPS might contribute to decreasing rates a private setting and tends to be more CFR 482.82 that currently require of home dialysis. In particular, comprehensive, while visits to multiple transplant centers to submit clinical commenters stated that the single in-center patients may be possible in the experience, outcomes, and other data in payment method would require ESRD same period of time. The GAO report order to obtain Medicare re-approval. facilities to bear the supply and noted, on the other hand, that monthly CMS proposed to remove these equipment costs associated with home physician payments for certain patients requirements in order to address dialysis modalities, and thus make them under 65 who undergo home dialysis unintended consequences of existing less economically feasible. We noted in training may begin the first month, requirements, which have resulted in response that while home dialysis instead of the fourth, of dialysis, which transplant programs potentially suppliers may not achieve the same may provide physicians with an avoiding performing transplant economies of scale as ESRD facilities, incentive to prescribe home dialysis. In procedures on certain patients and suppliers would remain able to provide addition, the GAO report stated that many organs with perceived risk factors Medicare makes a one-time payment for going unused out of fear of being 119 Medicare Claims Processing Manual, Chapter 8, 140; https://www.cms.gov/Regulations-and- 121 United States Government Accountability 123 United States Government Accountability Guidance/Manuals/Downloads/clm104.c08.pdf. Office, 2015. Office, 2015. 120United States Government Accountability 122 United States Government Accountability 124 United States Government Accountability Office 2015. Office, 2015. Office. 2015.

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penalized for outcomes that are non- dialysis facilities, nephrologists, and transplants that may, according to the compliant with § 482.82. According to other health care providers join together literature described earlier in this the proposed rule, transplant programs to form ESRD Seamless Care section IV of the rule, be subject to have avoided using these kidneys for Organizations (ESCOs) that are barriers. Specifically, with regard to fear of non-compliance with the responsible for the cost and quality of home dialysis, we acknowledge the Conditions of Participation for care for aligned beneficiaries. Although possible need for ESRD facilities to transplant centers in hospitals there are no specific incentives under invest in new systems that ensure that (§§ 482.80 and 482.82) and potential the CEC Model relating to home appropriate equipment and supplies are Medicare termination of the program, dialysis, CMS evaluated whether total available in an economical manner to despite evidence to the contrary that the cost of care incentives caused an support greater utilization by use of these kidneys would not pose a increase in the rate of home dialysis, as beneficiaries. We also recognize that problem for transplant recipients. would be predicted by some of the dialysis providers, nephrologists, and Although CMS proposed to remove literature, during the first year of the other clinicians would need to enhance certain requirements at § 482.82, CMS CEC Model. To date, the evaluation has education and training, both for patients emphasized that transplant programs not shown any statistically significant and professionals, that there are barriers should focus on maintaining high impact on the rates of home dialysis to patients choosing and accepting standards that protect patient health and among CEC Model participants.125 home dialysis modalities, and that the safety and produce positive outcomes Although the evaluation results appropriateness of home dialysis as a for transplant recipients. CMS stated available for the CEC Model thus far are treatment option varies among patients that the agency will continue to monitor limited, based on these preliminary according to demographic and clinical and assess outcomes, after initial findings CMS believes that more characteristics, as well as personal Medicare approval. (83 FR 47706) targeted, system-wide incentives may be choice. On November 14, 2018, CMS necessary to encourage modality choices As previously described, the duration published in the Federal Register a final and that the agency must provide of the payment adjustments under the rule entitled ‘‘Medicare Program; End- explicit incentives in order to affect ETC Model would be 6 years and 6 Stage Renal Disease Prospective behavior changes by providers and months, beginning on January 1, 2020, Payment System, Payment for Renal suppliers. and ending on June 30, 2026. We also Dialysis Services Furnished to On July 10, 2019, CMS announced considered an alternate start date of Individuals With Acute Kidney Injury, four voluntary kidney models: The April 1, 2020, to allow more time to End-Stage Renal Disease Quality Kidney Care First (KCF) Model, and prepare for Model implementation. If Incentive Program, Durable Medical three Comprehensive Kidney Care the ETC Model were to begin April 1, Equipment, Prosthetics, Orthotics and Contracting (CKCC) Models. These 2020, all intervals within the currently Supplies (DMEPOS) Competitive models build on the existing CEC proposed timelines, including the Bidding Program (CBP) and Fee Model, and include incentives for periods of time for which claims would Schedule Amounts, and Technical coordinating care for aligned be subject to adjustment by the HDPA Amendments To Correct Existing beneficiaries with CKD or ESRD and for and the Measurement Years and Regulations Related to the CBP for reducing the total cost of care for these Performance Payment Adjustment Certain DMEPOS’’ (CY 2019 ESRD PPS beneficiaries, as well as providing Periods used for purposes of applying final rule) (83 FR 56922). In that final financial incentives for successful the PPA, would remain the same length, rule, CMS adopted a new measure for transplants. We view the KCF Model but start and end dates would be the ESRD Quality Incentive Program and the CKCC Models as adjusted to occur 3 months later. We (QIP) beginning with PY 2022, entitled complementary to the proposed ETC seek comment on the alternative start the Percentage of Prevalent Patients Model, as both models would date, April 1, 2020, and the subsequent Waitlisted (PPPW) measure, and placed incentivize a greater focus on kidney three month adjustment to all ETC that measure in the Care Coordination transplants. We propose that ESRD Model dates, including the domain for purposes of performance facilities and Managing Clinicians may implementation of the HDPA and PPA. scoring under the program. The participate in both the ETC Model and We are also including the following adoption of this measure reflects CMS’s either the KCF Model or one of the proposals for the Model: (a) The method belief that ESRD facilities should make CKCC Models, as discussed in section for selecting ESRD facilities and better efforts to ensure that their IV.C.6. of this proposed rule. Managing Clinicians for participation; patients are appropriately waitlisted for (b) the schedule and methodologies for transplants (83 FR 57006). The proposed C. Provisions of the Proposed Regulation payment adjustments under the Model, ETC Model would provide greater 1. Proposal To Implement the ETC and waivers of Medicare payment incentives for ESRD facilities and Model requirements necessary solely to test Managing Clinicians participating in the these methodologies under the Model; Model to assist ESRD beneficiaries with In this section IV of the proposed rule, (c) the performance assessment navigating the transplant process, we propose our policies for the ETC methodology for ETC Participants, including coordinating care to address Model, including model-specific including the proposed methodologies clinical and non-clinical factors that definitions and the general framework for beneficiary attribution, impact eligibility for wait-listing and for implementation of the ETC Model. benchmarking and scoring, and transplantation. The proposed payment adjustments are calculating the Modality Performance designed to support increased Score; (d) monitoring and evaluation, b. Alternative Payment Models utilization of home dialysis modalities including quality measure reporting; Recognizing the importance of and kidney and kidney-pancreas and (e) overlap with other CMS models ensuring quality coordinated care to and programs. beneficiaries with ESRD, in 2015, CMS 125 Marrufo G, et al. Comprehensive End-Stage We propose to codify the definitions Renal Disease Care (CEC) Model: Performance Year began testing the Comprehensive ESRD 1 Annual Evaluation Report. CMS Innovation and policies of the ETC Model at Care (CEC) Model. The CEC Model is an Center. November 2017; innovation.cms.gov/Files/ subpart C of part 512 of 42 CFR accountable care model in which reports/cec-annrpt-py1.pdf. (proposed §§ 512.300 through 512.397).

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We discuss the proposed definitions in as a Medicare-enrolled physician or included in the model test and section IV.C.2 of this proposed rule and non-physician practitioner who comparison groups in order to detect a each of the proposed regulatory furnishes and bills the MCP for change in the rate of transplantation provisions under the applicable subject managing one or more adult ESRD under the ETC Model. area later. Section II of this proposed beneficiaries. We considered limiting Second, we believe that a mandatory rule proposes that the general the definition to nephrologists, or other design combined with randomized provisions proposed to be codified at specialists who furnish dialysis care to selection of a subset of geographic areas §§ 512.100 through 512.180 would beneficiaries with ESRD, for purposes of would enable CMS to better assess the apply to both the proposed ETC Model the ETC Model. However, analyses of effect of the Model’s interventions on and the proposed RO Model described claims data revealed that a variety of ETC Participants against a in section III of this proposed rule. clinician specialty types manage ESRD contemporaneous comparison group. As beneficiaries and bill the MCP, described in greater detail elsewhere in 2. Definitions including non-physician practitioners. this section IV of the proposed rule, we We propose at § 512.310 to define We believe that the proposed approach propose to require participation by a certain terms for the ETC Model. We to defining Managing Clinicians more subset of all ESRD facilities and describe these proposed definitions in accurately captures the set of Managing Clinicians in the U.S., context throughout this section IV of practitioners we are seeking to include selected based on whether they are this proposed rule. We seek comment as participants in the ETC Model, rather located in a selected geographic area. on the proposed definitions as a part of than limiting the scope to self-identified Also, we propose to evaluate the impact our seeking comment on the proposed nephrologists. of adjusting payments to Managing Clinicians and ESRD facilities by policies for the ETC Model. If finalized, The ETC Model would require the comparing the clinical and financial the definitions proposed in section II of participation of ESRD facilities and outcomes of ESRD facilities and this proposed rule also would apply to Managing Clinicians in selected Managing Clinicians located in these the ETC Model. geographic areas that might not selected geographic areas against that of otherwise participate in a payment 3. ETC Participants ESRD facilities and Managing Clinicians model involving payment adjustments located in comparison geographic areas. a. Mandatory Participation based on participants’ rates of home Because both ETC Participants and We propose to require all Managing dialysis and kidney transplants. those ESRD facilities and Managing Clinicians and all ESRD facilities Participation in other CMS models Clinicians not selected for participation located in selected geographic areas to focused on ESRD, such as the CEC in the Model would be representative of participate in the ETC Model. We Model the KCF Model, and the CKCC the larger dialysis market, many of the propose to define ‘‘selected geographic Models, is optional. Interested stakeholders in which operate on a area(s)’’ as those Hospital Referral individuals and entities must apply to nationwide basis, CMS would be able to Regions (HRRs) selected by CMS, as such models during the applicable generate more generalizable results. described in section IV.C.3.b of this application period(s) to participate. To This proposed model design would proposed rule, for purposes of selecting date, we have not tested an ESRD- therefore make it easier for CMS to ESRD facilities and Managing Clinicians focused payment model in which ESRD evaluate the impact of the Model, as required to participate in the ETC Model facilities and Managing Clinicians have required under section 1115A(b)(4) of as ETC Participants. Our proposed been required to participate. We the Act, and to predict the impact of definition of ‘‘Hospital Referral Regions considered using a voluntary design for expanding the Model under section (HRRs)’’ is described in section IV.C.3.b the ETC Model as well; however, we 1115A(c) of the Act, if authorized, while of the proposed rule. believe that a mandatory design has also limiting the scope of the model test For purposes of the ETC Model, we advantages over a voluntary design that to selected geographic areas. propose to define ‘‘ESRD facility’’ as are necessary to test this Model, in We invite public comments on our defined in 42 CFR 413.171. Under particular. First, we believe that testing proposal for mandatory participation, as § 413.171, an ESRD facility is an a new payment model specific to well as our proposal to select ETC independent facility or a hospital-based encouraging home dialysis and kidney Participants based on their location in a provider of services (as described in 42 transplants may require the engagement selected geographic area. CFR 413.174(b) and (c)), including of an even broader set of ESRD care facilities that have a self-care dialysis providers than have participated in b. Selected Geographic Areas unit that furnish only self-dialysis CMS models to date, including We propose to use an ESRD facility’s services as defined in § 494.10 and providers and suppliers who would or Managing Clinician’s location in meets the supervision requirements participate only in a mandatory ESRD selected geographic areas, randomly described in 42 CFR part 494, and that payment model. We are concerned that selected by CMS, as the mechanism for furnishes institutional dialysis services only a non-representative and relatively selecting ETC Participants. We believe and supplies under 42 CFR 410.50 and small sample of providers and that geographic areas would provide the 410.52. We propose this definition suppliers, namely those that already best means to establish the group of because this is the definition used by have higher rates of home dialysis or providers and suppliers selected for Medicare for the ESRD PPS. We kidney transplants relative to the participation in the Model and the considered creating a definition specific national benchmarks, would participate group of providers and suppliers not to the ETC Model; however, we believe in a voluntary model, which would not selected for participation in the Model that the ESRD PPS definition of ESRD provide a robust test of the proposed to answer the primary evaluation facility captures all facilities that payment incentives. In addition, questions described in section IV.C.11 furnish renal dialysis services that we because kidney and kidney-pancreas of this proposed rule. Specifically, by are seeking to include as participants in transplants are rare events—fewer than using geographic areas as the unit for the ETC Model. 4 percent of ESRD beneficiaries received randomized selection, we would be able For purposes of the ETC Model, we such a transplant in 2016—we need a to study the impact of the Model on propose to define ‘‘Managing Clinician’’ large number of beneficiaries to be program costs and quality of care, both

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overall and between ESRD facilities and represents an increase of 18 percent. To care. Additionally, the use of counties Managing Clinicians selected for detect an effect size of this magnitude or states could introduce confounding participation in the proposed Model and with 80 percent power and an alpha of spillover effects, such as where ESRD those ESRD facilities and Managing 0.05, we would need few HRRs beneficiaries receive care from a Clinicians not selected for participation included in the intervention group Managing Clinician in a county or state in the Model. However for transplants, which are rare selected for the Model and dialyze in a To improve the statistical power of events, a substantial number of HRRs county or state not selected for the the Model’s evaluation, we aim to would be needed to detect changes. Model, thus mitigating the effect of the include in the Model approximately 50 OACT did not assume any change in its Model’s incentives on the beneficiary’s percent of adult ESRD beneficiaries. To main projections but estimated that an overall care. HRRs are derived from achieve this goal, we propose to assign additional 2,360 transplants would Medicare data based on hospital referral all geographic areas, specifically HRRs, occur over the course of the proposed patterns, which are correlated with into one of two categories: Selected Model due to a lower discard rate for dialysis and transplant referral patterns geographic areas (those geographic areas deceased donor organs. With 20,161 and which would therefore mitigate for which ESRD facilities and Managing transplants currently conducted on an potential spillover effects of this nature. Clinicians located in the area would be annual basis,127 this represents an 11.7 In the alternative, we would consider selected for participation in the ETC percent increase over 5 years. To detect using CBSAs as the geographic unit of Model and would be subject to the an effect size of this magnitude with 80 selection, and assigning rural counties Model’s Medicare payment adjustments percent power and an alpha of 0.05, we not included in CBSAs to the nearest for ESRD care, if finalized); and would need approximately 153 HRRs in CBSA, as this approach would use an comparison geographic areas (those the intervention group, which existing methodology already used by geographic areas for which ESRD represents 50 percent of the 306 HRRs CMS to denote regions (CBSAs, which facilities and Managing Clinicians in the US. We believe random selection are used, among other things, in located in the area would not be with a large sample of units, such as the determining the wage index adjustments selected for participation in the ETC 306 HRRs, would safeguard against to Medicare inpatient prospective Model and thus would be subject to uneven distributions of factors among payment system rates to account for customary Medicare payment for ESRD selected geographic areas and variation in hospital wages and wage- care). Given the national scope of the comparison geographic areas, such as related costs related to location), while major stakeholders in the dialysis urban or rural markets, dominance of also making sure that a random market and the magnitude of the for-profit dialysis organizations, and selection of providers and suppliers payment adjustments proposed for this dense population areas with greater located in rural areas are included as Model, we believe a broad geographic access to transplant centers. participants in the ETC Model. distribution of participants would be We considered using Core Based We propose to establish the selected necessary to effectively test the impact Statistical Areas (CBSAs) or geographic areas by selecting a random of the proposed payment adjustments. Metropolitan Statistical Areas (MSAs) as sample of 50 percent of HRRs in all 50 We propose to use HRRs as the the geographic unit of selection. geographic unit of selection for selecting states and the District of Columbia, However, neither CBSAs nor MSAs stratified by region. Regional ETC Participants. An HRR is a unit of include rural areas and, due to the analysis created by the Dartmouth Atlas stratification would use the four Census- nature of dialysis treatment, we believe defined geographic regions: Northeast, Project to distinguish the referral inclusion of rural providers and patterns to tertiary care for Medicare South, Midwest, and West. Information suppliers is vital to testing the Model. about Census-defined geographic beneficiaries, and is composed of groups Specifically, as a significant proportion of zip codes. The Dartmouth Atlas regions is available at https:// of beneficiaries receiving dialysis live in www.census.gov/geo/reference/gtc/gtc_ Project data source is publicly available rural areas and receive dialysis _ at https://www.dartmouthatlas.org/. census divreg.html. The stratification treatment from providers and suppliers would control for regional patterns in Therefore, we propose to define the located in rural areas, we believe using term ‘‘HRRs’’ to mean the regional practice variation. If an HRR spans two a geographic unit of selection that does or more Census-defined geographic markets for tertiary medical care derived not include rural areas would limit the from Medicare claims data as defined by regions, the HRR would be assigned to generalizability of the model findings to the region in which the HRR’s the Dartmouth Atlas Project at https:// this population. www.dartmouthatlas.org/. associated state is located. For example, We also considered using counties or the Rapid City HRR centered in Rapid With 306 HRRs in the U.S., we believe states as the geographic unit of there would be a sufficient number of City, South Dakota, contains zip codes selection. However, we determined that located in South Dakota and Nebraska, HRRs to support random selection and counties would be too small and improve statistical power of the which are in the Midwest Census therefore too operationally challenging Region, and zip codes located in proposed Model’s evaluation. We to use for this purpose, both due to the conducted power calculations for the Montana and Wyoming, which are in high number of counties and the the West Census Region. For the outcomes of home dialysis and kidney relatively small size of counties such and kidney pancreas transplant purposes of the regional stratification, that a substantial number of Managing we would consider the Rapid City HRR utilization. For home dialysis, the CMS Clinicians practice in multiple counties. Office of the Actuary (OACT) forecasts and all zip codes therein to be in the We also determined that states would be an average increase of 1.5 percentage Midwest region, as its affiliated state, too heterogeneous in population size, points per year. With a current home South Dakota, is in the Midwest region. and that using states could confound the dialysis rate of 8.6 percent,126 this We propose that the U.S. Territories, model test due to potential variation in as that term is proposed to be defined state-level regulations relating to ESRD 126 United States Renal Data System, Annual Data in section II of this proposed rule, Report, 2018. Volume 2. Chapter 1: Incidence, would be excluded from selection, as Prevalence, Patient Characteristics, and Treatment 127 United States Renal Data System, Annual Data Modalities. https://www.usrds.org/2018/view/v2_ Report, 2018. Volume 2. Chapter 6: Transplantation. HRRs are not constructed to include 01.aspx. https://www.usrds.org/2018/view/v2_06.aspx. these areas.

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In addition, outside of the c. Participant Selection for the ETC Clinicians for participation in the ETC randomization, we propose that all Model Model. HRRs for which at least 20 percent of We propose to define ‘‘ETC 4. Home Dialysis Payment Adjustment the component zip codes are located in Participant’’ as an ESRD facility or Maryland would be selected for Managing Clinician that is required to We propose to positively adjust participation in the ETC Model, in participate in the ETC Model in payments for home dialysis and home conjunction with the Maryland Total accordance with proposed § 512.325(a), dialysis-related services billed by ETC Cost of Care (TCOC) Model currently which describes the selection of model Participants for claims with claim being tested in Maryland. These HRRs participants based on their location through dates during the first three CYs would not be included in the within a selected geographic area, as of the ETC Model (CY 2020–CY 2022). randomization process previously previously described. In addition, we The HDPA would provide an up-front described. CMS believes that the note that the proposed definition of positive incentive for ETC Participants automatic inclusion of ESRD facilities ‘‘model participant,’’ as defined in to support ESRD beneficiaries in and Managing Clinicians in these HRRs section II of this proposed rule, would choosing home dialysis. The HDPA as participants in the ETC Model would include an ETC Participant. would complement the PPA, described in section IV.C.5 of this proposed rule, be necessary because, while the (1) ESRD Facilities Maryland TCOC Model includes which would begin in mid-CY 2021 and incentives to lower the Medicare TCOC We propose that all Medicare-certified increase in magnitude over the duration of the Model; as such we propose that in the state, including state ESRD facilities located in a selected the HDPA would decrease over time as accountability for meeting certain geographic area would be required to the magnitude of the PPA increases. Medicare TCOC targets, as well as global participate in the ETC Model. We There would be two types of HDPAs: budget payments that hold Maryland propose to determine ESRD facility The Clinician HDPA and the Facility hospitals accountable for the Medicare location based on the zip code of the practice location address listed in the HDPA. We propose to define the TCOC, there currently is no direct ‘‘Clinician HDPA’’ as the payment mechanism to lower the cost of care for Medicare Provider Enrollment, Chain, and Ownership System (PECOS). We adjustment to the MCP for a Managing ESRD beneficiaries specifically under considered using the zip code of the Clinician who is an ETC Participant for the Maryland TCOC Model. We believe mailing address listed in PECOS. the Managing Clinician’s home dialysis that adding Maryland-based ESRD However, we concluded that mailing claims, as described in proposed facilities and Managing Clinicians as address is a less reliable indicator of § 512.345 (Payments Subject to the participants in the proposed ETC Model where a facility is physically located Clinician HDPA) and § 512.350 would assist the state of Maryland and than the practice location address, as (Schedule of Home Dialysis Payment hospitals located in that state to meet facilities may receive mail at a different Adjustments). We propose to define the the Medicare TCOC targets established location than where they are physically ‘‘Facility HDPA’’ as the payment under the Maryland TCOC Model. located. adjustment to the Adjusted ESRD PPS We propose that all HRRs that are not We invite public comment on this per Treatment Base Rate for an ESRD selected geographic areas would be proposal for identifying where ESRD facility that is an ETC Participant for the referred to as ‘‘comparison geographic facilities are located for purposes of ESRD facility’s home dialysis claims, as area(s).’’ We propose that comparison selecting ESRD facilities for described in proposed § 512.340 geographic areas would be used for the participation in the ETC Model. (Payments Subject to the Facility HDPA) and § 512.350 (Schedule of Home purposes of constructing performance (2) Managing Clinicians benchmarks (as discussed in section Dialysis Payment Adjustments). We IV.C.5.d of this proposed rule), and for We propose that all Medicare-enrolled propose to define the ‘‘HDPA’’ as either the Model evaluation (as discussed in Managing Clinicians located in a the Facility HDPA or the Clinician section IV.C.11 of this proposed rule). selected geographic area would be HDPA. We do not believe that an required to participate in the ETC analogous payment adjustment is We invite public comments on our Model. We propose to identify the necessary for increasing kidney proposal to use HRRs as the geographic Managing Clinician’s location based on transplant rates during the initial years unit of selection, with regional the zip code of the practice location of the ETC Model. Rather, instead of stratification, and to exclude U.S. address listed in PECOS. If a Managing creating a payment adjustment, we Territories from the selected geographic Clinician has multiple practice location propose to implement a learning areas. We invite comment on our addresses listed in PECOS, we would collaborative that focuses on alternative consideration to use CBSAs use the practice location through which disseminating best practices to increase as the geographic unit of selection, and the Managing Clinician bills the the supply of deceased donor kidneys assign rural counties not included in plurality of his or her MCP claims. We available for transplant. For a CBSAs to the nearest CBSA. We also considered using the zip code of the description of the learning collaborative, invite comment on the inclusion of all mailing address listed in PECOS. see section IV.C.12 of this proposed HRRs for which at least 20 percent of However, we determined that mailing rule. the component zip codes are located in address is a less reliable indicator of a. Payments Subject to the HDPA Maryland, separate from the where a clinician physically practices randomization, as well as whether HRRs than the practice location address, as We propose that the HDPA would that include areas included in the clinicians may receive mail at a apply to all ETC Participants for those Pennsylvania Rural Health Model, the different location from where they payments described in sections IV.C.4.b Vermont All-Payer ACO Model, or physically practice. and IV.C.4.c of this proposed rule, future state-based models tested under We invite public comment on this according to the proposed schedule section 1115A of the Act should also be proposal for identifying where described in section IV.C.4.d of this selected geographic areas for purposes Managing Clinicians are located for proposed rule. We solicit comment on of the ETC Model. purposes of selecting Managing the proposal to apply the HDPA with

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respect to all ETC Participants, without Medicare Secondary Payer calculation current formula for determining the exceptions. and payment rules would apply, final ESRD PPS per treatment payment We also propose that the HDPA possibly leading to an adjustment to the amount is as follows: would apply to claims where Medicare Medicare Secondary Payer amount. We Final ESRD PPS Per Treatment Payment is the secondary payer for coverage seek comment on the proposal to apply Amount = (Adjusted ESRD PPS the HDPA to Medicare as secondary under section 1862(b)(1)(C) of the Act. Base Rate + Training Add On + payer claims. When a beneficiary eligible for coverage TDAPA) * ESRD QIP Factor + under an employee group health plan b. Facility HDPA Outlier Payment * ESRD QIP Factor becomes eligible for Medicare because For ESRD facilities that are ETC Under our proposal, we would apply he or she has developed ESRD, there is Participants, we propose to adjust the Facility HDPA to the Adjusted ESRD a 30 month coordination period during Medicare payments under the ESRD PPS per Treatment Base Rate on claims which the beneficiary’s group health PPS for home dialysis services by the submitted for home dialysis services. plan remains the primary payer if the HDPA according to the proposed For purposes of the ETC Model, we beneficiary was previously insured. schedule described in section IV.C.4.d propose to define the ‘‘Adjusted ESRD During this time, Medicare is the of this proposed rule. As noted PPS per Treatment Base Rate’’ as the per secondary payer for these beneficiaries. previously, under the ESRD PPS, a treatment payment amount as defined in We propose to apply the HDPA to single per treatment payment is made to 42 CFR 413.230, including patient-level Medicare as secondary payer claims an ESRD facility for all renal dialysis adjustments and facility-level because the initial transition period services and home dialysis services adjustments, and excluding any onto dialysis is important for supporting furnished to beneficiaries. This payment applicable training adjustment add-on beneficiaries in selecting home dialysis, is subject to a number of adjustments, payment amount, outlier payment as beneficiaries who begin dialysis at including patient-level adjustments, amount, and TDAPA amount. The home are more likely to remain on a facility-level adjustments, and, when proposed formula for determining the home modality. The HDPA would applicable, a training adjustment add-on final ESRD PPS per treatment payment adjust the Medicare payment rate for the for home and self-dialysis modalities, an amount with the Facility HDPA would initial claim, and then the standard outlier payment, and the TDAPA. The be as follows:

We considered adjusting the full date during a CY subject to adjustment, We seek comment on this proposed ESRD PPS per treatment payment as described in section IV.C.4.d of this provision. amount by the Facility HDPA, including proposed rule, where the beneficiary is As further described in section any applicable training adjustment add- age 18 or older during the entire month IV.C.7.a of this proposed rule, we also on payment amount, outlier payment of the claim. Facility code 7 (the second propose that the Facility HDPA would amount, and TDAPA. However, we digit of Type of Bill) paired with type not affect beneficiary cost sharing. concluded that adjusting these of care code 2 (the third digit of Type Beneficiary cost sharing instead would additional payment amounts was not of Bill), indicates that the claim be based on the amount that would have necessary to create the financial occurred at a clinic or hospital-based been paid under the ESRD PPS absent incentives we seek to test under the ESRD facility. Type of Bill 072X the Facility HDPA. proposed ETC Model. We seek comment captures all renal dialysis services c. Clinician HDPA on our proposed definition of the furnished at or through ESRD facilities. Adjusted ESRD PPS per Treatment Base Condition codes 74 and 75 indicate For Managing Clinicians that are ETC Rate, and the implications of excluding Participants, we propose to adjust the billing for a patient who received from the definition the adjustments and MCP by the Clinician HDPA when dialysis services at home, and condition payment amounts previously listed, billed for home dialysis services. We such that those amounts would not be code 80 indicates billing for a patient propose to define the ‘‘MCP’’ as the adjusted by the Facility HDPA under the who received dialysis services at home monthly capitated payment made for ETC Model. and the patient’s home is a nursing each ESRD beneficiary to cover all We propose in § 512.340 to apply the facility. Condition code 76 indicates routine professional services related to Facility HDPA to the Adjusted ESRD billing for a patient who dialyzed at treatment of the patient’s renal PPS per Treatment Base Rate on claim home but received back-up dialysis in a condition furnished by a physician or lines with Type of Bill 072X, where the facility. Taken together, we believe non-physician practitioner as specified type of facility code is 7 and the type these condition codes capture home in 42 CFR 414.314. We considered of care code is 2, and with condition dialysis services furnished by ESRD adjusting all Managing Clinician claims codes 74, 75, 76, or 80, when the claim facilities, and therefore are the codes we for services furnished to ESRD is submitted by an ESRD facility that is propose to use to identify those beneficiaries, including those not for an ETC Participant with a claim through payments subject to the Facility HDPA. dialysis management services. However,

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we concluded that adjusting claims for effect: A process-based incentive from § 512.375(a) (Payments Subject to services other than dialysis management the HDPA and an outcomes-based Adjustment) and proposed § 512.380 was not necessary to create the financial incentive from the home dialysis (PPA Amounts and Schedule). We incentives we seek to test under the component of the PPA. While we propose to define the ‘‘PPA’’ as either proposed ETC Model. believe that the time-limited overlap the Facility PPA or the Clinician PPA. We propose in § 512.345 to adjust the between the two payment adjustments a. Annual Schedule of Performance amount otherwise paid under Part B is acceptable to smoothly transition ETC Assessment and PPA with respect to MCP claims on claim Participants from process-based lines with CPT® codes 90965 and 90966 incentives to outcomes-based We propose to assess ETC Participant by the Clinician HDPA when the claim incentives, we do not believe this performance on the home dialysis rate is submitted by a Managing Clinician structure is beneficial to the Model test and the transplant rate, described in who is an ETC Participant with a claim over the long term. sections IV.C.5.c.1 and IV.C.5.c.2 through date during a CY subject to We propose the payment adjustment respectively, of this proposed rule, and adjustment, as described in section schedule in Table 11: to make corresponding payment IV.C.4.d of this proposed rule, where the adjustments according to the proposed beneficiary is age 18 or older for the TABLE 11—PROPOSED HDPA schedule described later. We propose in ® entire month of the claim. CPT code SCHEDULE § 512.355(a) that we would assess the 90965 is for ESRD related services for home dialysis rate and transplant rate home dialysis per full month for CY CY CY for each ETC Participant during each of patients 12–19 years of age. CPT® code 2020 2021 2022 the Measurement Years, which would 90966 is for ESRD related services for Magnitude of Payment Adjust- include 12 months of performance data. home dialysis per full month for ment ...... +3% +2% +1% For the ETC Model, we propose to patients 20 years of age and older. These define ‘‘Measurement Year (MY)’’ as the two codes are used to bill the MCP for Under this proposed schedule, the 12-month period for which achievement patients age 18 and older who dialyze HDPA would no longer apply to claims and improvement on the home dialysis at home, and therefore are the codes we submitted by ETC Participants with rate and transplant rate are assessed for propose to use to identify those claim through dates on or after January the purpose of calculating the ETC payments subject to the HDPA. As noted 1, 2023. We seek input from the public Participant’s MPS and corresponding previously, we propose to adjust the about the proposed magnitude and PPA. Further, we propose in amount otherwise paid under Part B by duration of the proposed HDPA. § 512.355(b) that we would adjust the Clinician HDPA so that beneficiary 5. Performance Payment Adjustment payments for ETC Participants by the cost sharing would not be affected by PPA during each of the PPA periods, the application of the Clinician HDPA. We propose to adjust payment for each of which would correspond to a The Clinician HDPA would apply only claims for dialysis services and dialysis- Measurement Year. We propose to to the amount otherwise paid for the related services submitted by ETC define ‘‘Performance Payment MCP absent the Clinician HDPA. We Participants based on each ETC Adjustment Period (PPA Period)’’ as the seek comment on this proposed Participant’s Modality Performance 6-month period during which a PPA is provision. Score (MPS), calculated as described in applied in accordance with proposed section IV.C.5.d of this proposed rule. § 512.380 (PPA Amounts and Schedule). d. HDPA Schedule and Magnitude We propose to define the ‘‘Modality Each MY included in the ETC Model We propose in new § 512.350 that the Performance Score (MPS)’’ as the and its corresponding PPA Period magnitude of the HDPA would decrease numeric performance score calculated would be specified in proposed over the CYs of the ETC Model test, as for each ETC Participant based on the § 512.355(c) (Measurement Years and the magnitude of the PPA increases. In ETC Participant’s home dialysis rate and Performance Payment Adjustment this way, we would transition from transplant rate, as described in proposed Periods). providing additional financial § 512.370(d) (Modality Performance Under our proposal, each MY would incentives to support the provision of Score), which is used to determine the overlap with the subsequent MY, if any, home dialysis through the HDPA in the amount of the ETC Participant’s PPA, as for a period of 6 months, as ETC initial three CYs of the ETC Model, to described in proposed § 512.380 (PPA Participant performance would be holding ETC Participants accountable Amounts and Schedule). We seek assessed and payment adjustments for attaining the outcomes that the comment on the composition of the would be updated by CMS on a rolling Model is designed to achieve via the MPS, particularly the inclusion of the basis. We believe that this method of PPA. We considered alternative transplant rate in the MPS. making rolling performance assessments durations of the HDPA, including There would be two types of PPAs: balances two important factors: The limiting the HDPA to one year such that The Clinician PPA and the Facility PPA. need for sufficient data to produce there would be no overlap between the We propose to define the ‘‘Clinician reliable estimates of performance, and HPDA and the PPA, or extending the PPA’’ as the payment adjustment to the the effectiveness of incentives that are HDPA for the entire duration of the MCP for a Managing Clinician who is an proximate to the period for which Model. However, we did not elect to ETC Participant based on the Managing performance is assessed. Beginning with propose these approaches. If the HDPA Clinician’s MPS, as described in MY 2, there would be a 6-month period applied for only the first year of the proposed § 512.375(b) (Payments of overlap between a MY and the Model, there would be a six month gap Subject to Adjustment) and proposed previous MY. For example, MY 1 would between the end of the HDPA § 512.380 (PPA Amounts and Schedule). begin January 1, 2020, and would run (December 31, 2020) and the start of the We propose to define the ‘‘Facility PPA’’ through December 31, 2020; and MY 2 first PPA period (July 1, 2021), during as the payment adjustment to the would begin 6 months later, running which there would be no model-related Adjusted ESRD PPS per Treatment Base from July 1, 2020, through June 30, payment adjustment. If the HDPA Rate for an ESRD facility that is an ETC 2021. Each MY would have a applied for the duration of the Model, Participant based on the ESRD facility’s corresponding PPA Period, which there would be two sets of incentives in MPS, as described in proposed would begin 6 months after the

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conclusion of the MY. For example, MY which would begin July 1, 2021, and In Table 12, we propose the following 1, which would end December 31, 2020, end December 31, 2021. schedule of MYs and PPA Periods: would correspond to PPA Period 1,

We invite public comment on the would have become eligible for be attributed to multiple ESRD facilities proposed schedule of MYs and Medicare if they did not receive a pre- and Managing Clinicians in one MY, but corresponding PPA Periods. emptive transplant and progressed to would be attributed to only one ESRD ESRD, requiring dialysis. This definition b. Beneficiary Population and facility and one Managing Clinician for would more accurately reflect the total Attribution a given month during the MY. A pre- number of transplants occurring in the emptive transplant beneficiary may be We propose that, in order to assess the population of patients who could attributed to only one Managing home dialysis rate and transplant rate receive pre-emptive transplants, and Clinician during a MY, regardless of the for ETC Participants, ESRD beneficiaries including these additional patients who number of months for which the would be attributed to participating receive pre-emptive transplants in the beneficiary is attributed to the Managing ESRD facilities and to participating calculation of the transplant rate could Clinician. Managing Clinicians. For purposes of better incentivize Managing Clinicians the ETC Model, we propose to define to support kidney transplants via the We considered conducting attribution ‘‘ESRD Beneficiary’’ as a beneficiary Clinician PPA. Due to data limitations prospectively, before the beginning of receiving dialysis or other services for about patients who are not Medicare the MY. However, we concluded that end-stage renal disease, up to and beneficiaries, however, we concluded prospective attribution would not be including the month in which he or she that we could not include patients who appropriate given the nature of ESRD receives a kidney or kidney-pancreas received pre-emptive transplants but and the ESRD beneficiary population. transplant. This would include were not Medicare beneficiaries in the CKD is a progressive illness, with beneficiaries who are on dialysis for construction of the transplant rate. patients moving from late stage CKD to treatment of ESRD, as well as Therefore, we are proposing to limit the ESRD—requiring dialysis or a beneficiaries who were on dialysis for definition of pre-emptive transplant transplant—throughout the course of the treatment of ESRD and received a beneficiary to include Medicare year. In this case, we believe kidney or kidney-pancreas transplant up beneficiaries only. prospective attribution would to and including the month in which We propose to attribute ESRD functionally exclude incident they received their transplant. Beneficiaries, and pre-emptive beneficiaries new to dialysis from Also, we propose to attribute pre- transplant beneficiaries where inclusion in the home dialysis and emptive transplant beneficiaries to applicable, to ETC Participants for each transplant rates of ETC Participants Managing Clinicians for purposes of month of each MY, and we further until the following MY. Additionally, calculating the transplant rate, propose that such attribution would be we believe that prospective attribution specifically. We propose to define a made after the end of each MY. We would not work well for the particular ‘‘pre-emptive transplant beneficiary’’ as considered attributing beneficiaries to design of this Model. In particular, a Medicare beneficiary who received a participating ESRD facilities and because the PPA would be determined kidney or kidney-pancreas transplant Managing Clinicians for the entire MY; based on home dialysis and transplant prior to beginning dialysis. This however, we believe monthly rates during the MY, limiting attribution definition would be mutually exclusive attribution would more accurately to beneficiaries with whom the ETC of the proposed definition of an ESRD capture the care relationship between Participant had a care relationship prior Beneficiary, as a pre-emptive transplant beneficiaries and their ESRD providers to the MY would not accurately capture beneficiary receives a kidney or kidney- and suppliers. As ETC Participant what occurred during the MY. We pancreas transplant prior to initiating behavior and care relationships with believe that conducting attribution dialysis and therefore is not an ESRD beneficiaries may change as a result of retrospectively, after the completion of Beneficiary. We considered defining the ETC Model, we believe that the level the MY, would better align with the this concept as pre-emptive transplant of precision associated with monthly design of the PPA in the ETC Model. We recipients, as there are patients who attribution of beneficiaries would better invite public comment on the proposal receive pre-emptive transplants who are support the ETC Model’s design. Under to attribute beneficiaries on a monthly not Medicare beneficiaries, but who our proposal, an ESRD Beneficiary may basis after the end of the relevant MY.

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We propose to provide ETC becomes permanent, such that the propose that the ESRD Beneficiary Participants lists of their attributed beneficiary is undergoing maintenance would be attributed to the ESRD facility beneficiaries after attribution has dialysis, then the beneficiary would be at which the beneficiary received the occurred, after the end of the MY. We eligible for attribution. earliest dialysis treatment that month. considered providing lists in advance of • Has a diagnosis of dementia, We propose that we would identify the MY, or on a more frequent basis. because conducting dialysis at home dialysis claims as those with Type of However, we determined that, since we may present an undue challenge for Bill 072X, where the type of facility would be conducting attribution after beneficiaries with dementia, and such code is 7 and the type of care code is the conclusion of the MY, prospective beneficiaries also may not prove to be 2, and that have a claim through date lists of attributed beneficiaries that appropriate candidates for transplant. during the month for which attribution attempted to simulate which We considered excluding is being determined. Type of Bill 072X beneficiaries would be attributed to a beneficiaries from attribution for the captures all renal dialysis services participant during the MY would be purposes of calculating the home furnished at or through ESRD facilities. potentially misleading. Additionally, as dialysis rate whose advanced age (for Facility code 7 paired with type of care the calculation of the home dialysis rate example, ages 70 and older) could make code 2 indicates that the claim occurred and transplant rate among attributed home dialysis inappropriate; however, at a clinic or hospital based ESRD beneficiaries would be conducted only we could not ascertain a consensus in facility. once every 6 months due to overlapping the literature that supported any In the alternative, we considered MYs, we believe providing lists after the specific age cut-off. We also considered attributing ESRD Beneficiaries to the MY would provide ETC Participants excluding beneficiaries with housing ESRD facility at which they had their sufficient information about their insecurity from attribution for the first dialysis treatment for which a claim attributed beneficiary populations to purposes of calculating the home was submitted in a given month. understand the basis of their rates of dialysis rate, but could not find an However, we determined that using the home dialysis and transplants. objective way to measure housing plurality of claims rather than earliest claim better identifies the ESRD facility (1) Beneficiary Exclusions instability. We invite public comment on the that has the most substantial care We propose to exclude certain proposed exclusions from beneficiary relationship with the ESRD Beneficiary categories of beneficiaries from attribution under the ETC Model, in question for the given month. For attribution to ETC Participants, including criteria according to which example, using the earliest claim consistent with other CMS models and dementia should be assessed, as well as approach could result in attributing a programs. Specifically, we are any others, for example, physical or beneficiary that received dialysis proposing to exclude an ESRD functional limitations, on the basis of treatments from Facility A once during Beneficiary or a pre-emptive transplant which beneficiaries should be excluded a given month and dialysis treatments beneficiary if, at any point during the from attribution. We also seek from Facility B at all other times during month, the beneficiary: comments as to whether we should that month to Facility A, even though • Is not enrolled in Medicare Part B, exclude beneficiaries over a specific age Facility B is the facility where the because Medicare Part B pays for the threshold, and whether there is an beneficiary received most of his or her majority of ESRD-related items and objective measure we could use for dialysis treatments that month. We do, services, for which Part B claims are housing insecurity. however, plan to use the earliest date of necessary for evaluation of the Model. service in the event that two or more • Is enrolled in Medicare Advantage, (2) Attribution Services ESRD facilities have furnished the same a cost plan, or other Medicare managed (a) Attribution to ESRD Facilities amount of services to a beneficiary care plans, because these plans have because, as between two or more different payment structures than We propose that, to be attributed to an facilities that performed the same Medicare Parts A and B and do not use ESRD facility for a month, an ESRD number of dialysis treatments for the FFS billing. beneficiary must have received renal beneficiary during a month, the facility • Does not reside in the United dialysis services, other than renal that furnished services to the States, because it is more difficult to dialysis services for AKI, during the beneficiary first may have established track and assess the care furnished to month from the ESRD facility. Because the beneficiary’s care plan and therefore beneficiaries who might have received it is possible that a single ESRD is the one more likely to have the most care outside of the U.S. Beneficiary receives dialysis treatment significant treatment relationship with • Is younger than age 18 at any point from more than one ESRD facility the beneficiary. We note that this in the month, because beneficiaries during a month, we further propose that proposed policy is consistent with the under age 18 are more likely to have ESRD Beneficiaries would be attributed CEC Model. ESRD from rare medical conditions that to an ESRD facility for a given month We also considered using a minimum have different needs and costs based on the ESRD facility at which the number of treatments at an ESRD associated with them than the typical ESRD Beneficiary received the plurality facility for purposes of ESRD ESRD beneficiary. of his or her dialysis treatments in that Beneficiary attribution. However, we • Has elected hospice, because month. We believe the plurality rule determined that, because we are hospice care generally indicates would provide a sufficient standard for attributing ESRD Beneficiaries on a cessation of dialysis treatment and attribution because it ensures that ESRD month-by-month basis, the plurality of curative care. Beneficiaries would be attributed to an treatments method would be more • Is receiving dialysis for acute ESRD facility when they receive more appropriate because it would result in a kidney injury (AKI) only, because renal renal dialysis services from that ESRD greater number of ESRD Beneficiaries dialysis services for AKI differ in care facility than from any other ESRD attributed to the ESRD facilities where and costs from a typical ESRD facility. In the event that an ESRD they receive care, which may enhance beneficiary who is not receiving care for Beneficiary receives an equal number of the viability of the ETC Model test. AKI. AKI is usually a temporary loss of dialysis treatments from two or more Additionally, we considered including a kidney function. If the kidney injury ESRD facilities in a given month, we minimum duration that an ESRD

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Beneficiary must be on dialysis before these are all the CPT® codes that are Medicare-enrolled providers and the beneficiary can be attributed to an used to bill the MCP that include suppliers, including Medicare ESRD facility. We determined that this beneficiaries 18 years old or older, enrollment and eligibility information, approach was not suitable for this including patients who dialyze at home practice and facility information, and model test, however, as a key factor that and patients who dialyze in-center. Medicare billing information. For the influences whether or not a beneficiary Additionally, for the transplant rate transplant rate calculations, CMS also chooses to dialyze at home is if the for Managing Clinicians, we would also proposes to use data from the Scientific beneficiary begins dialysis at home, attribute pre-emptive transplant Registry of Transplant Recipients rather than in-center. Requiring a beneficiaries to Managing Clinicians. (SRTR), which contains comprehensive minimum duration on dialysis would Because pre-emptive transplant information about transplants that occur exclude these early months of dialysis beneficiaries have not started dialysis at in the U.S., to identify transplants treatment from attribution, which may the time of their transplant, we would among attributed beneficiaries for be key to a beneficiary’s modality not be able to attribute them to inclusion in the numerator about the choice, and would therefore run counter Managing Clinicians based on MCP occurrence of kidney and kidney- to the intent of the proposed Model. claims, as we would for ESRD pancreas transplants. We considered We propose that CMS would not Beneficiaries. Rather, we propose that requiring ETC Participants to report on attribute pre-emptive transplant pre-emptive transplant beneficiaries their home dialysis and transplant rates, beneficiaries to ESRD facilities because would be attributed to a Managing as this would give ETC Participants beneficiaries who receive pre-emptive Clinician based on the Managing more transparency into their rates. transplants do so before they have Clinician with whom the beneficiary However, we believe basing the rates on initiated dialysis and thus do not have had the most claims between the start of claims data, supplemented with a care relationship with the ESRD the MY and the month in which the Medicare administrative data about facility. beneficiary received the transplant, and beneficiary enrollment and transplant We seek comment on the proposed that the pre-emptive transplant registry data about transplant methodology for attributing ESRD beneficiary would be attributed to the occurrences, would ensure there is no Beneficiaries to ESRD facilities and the Managing Clinician for all months new reporting burden on ETC alternatives considered, as well as our between the start of the MY and the Participants. Additionally, using these proposal not to attribute pre-emptive month in which the beneficiary received existing data sources would be more transplant beneficiaries to ESRD the transplant. We considered cost effective for CMS, as it would not facilities. attributing pre-emptive transplant require the construction and beneficiaries on a month-by-month maintenance of a new reporting portal, (b) Attribution to Managing Clinicians basis, mirroring the month-by-month or changes to an existing reporting We propose that, for Managing attribution of ESRD Beneficiaries. portal to support this data collection. Clinicians, an ESRD Beneficiary would However, we concluded that this We solicit comment on our proposed be attributed to the Managing Clinician approach would under-attribute use of claims data, Medicare beneficiary who submitted an MCP claim with a beneficiary months to the denominator. enrollment data, and transplant registry claim through date in a given month for Unlike ESRD Beneficiaries who see their data to calculate the home dialysis rate certain services furnished to the ESRD Managing Clinician every month for and transplant rate. beneficiary. Per the conditions for dialysis management, pre-emptive (1) Home Dialysis Rate billing the MCP, the MCP can only be transplant beneficiaries generally do not billed once per month for a given see a Managing Clinician every month We propose to define ‘‘home dialysis beneficiary.128 Therefore, we believe because they have not started dialysis. rate’’ as the rate of ESRD Beneficiaries there is no need to create a decision rule However, that does not mean that an attributed to the ETC Participant who for attributing ESRD Beneficiaries to a ongoing care relationship does not exist dialyzed at home during the relevant Managing Clinician for a given month if between the pre-emptive transplant MY, as described in § 512.365(b) (Home there are multiple MCP claims that beneficiary and the Managing Clinician Dialysis Rate). We propose to construct month, as that should never happen. We in a month with no claim. the home dialysis rate for ETC propose that, for purposes of ESRD We seek comment on the proposed Participants that are ESRD facilities as Beneficiary attribution to Managing methodology for attributing ESRD described in section IV.C.5.c.1.a of this Clinicians, we would include MCP Beneficiaries and pre-emptive proposed rule and for ETC Participants claims with CPT® codes 90957, 90958, transplant beneficiaries to Managing who are Managing Clinicians as 90959, 90960, 90961, 90962, 90965, or Clinicians and the alternatives described in section IV.C.5.c.1.b of this 90966. CPT® codes 90957, 90958, considered. proposed rule. We solicit comment on our proposed 90959, 90960, 90961, and 90962 are for c. Performance Measurement ESRD-related services furnished methodology for assessing home We propose to calculate the home monthly, and indicate beneficiary age dialysis rates for ESRD facilities and dialysis and transplant rates for ESRD (12–19, or 20 years of age and older) and Managing Clinicians that are ETC facilities and Managing Clinicians using the number of face-to-face visits with a Participants, as well as alternative Medicare claims data and Medicare physician or other qualified health care methodologies for assessing home administrative data about beneficiaries, professional per month (1, 2–3, 4 or dialysis rates. We describe later our ® providers, and suppliers. Medicare more). CPT codes 90965 and 90966 are proposed plan for risk adjusting and administrative data refers to non-claims for ESRD-related services for home reliability adjusting these rates. data that Medicare uses as part of dialysis per full month, and indicate the regular operations. This includes (a) Home Dialysis Rate for ESRD age of the beneficiary (12–19, or 20 information about beneficiaries, such as Facilities years of age and older). Taken together, enrollment information, eligibility Under our proposal, the denominator 128 Medicare Claims Processing Manual, Chapter information, and demographic of the home dialysis rate for ESRD 8; https://www.cms.gov/Regulations-and-Guidance/ information. Medicare administrative facilities would be the total dialysis Manuals/Downloads/clm104.c08.pdf. data also refers to information about treatment beneficiary years for

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attributed ESRD Beneficiaries during the beneficiary choice regarding ESRD related services for home dialysis per MY. Dialysis treatment beneficiary years treatment modality. However, these full month for patients 20 years of age included in the denominator would be modalities lack clear definitions in the and older. These two codes are used to composed of those months during literature and delivery of care for these bill the MCP for beneficiaries aged 18 which attributed ESRD beneficiaries modalities is billed through the same and older who dialyze at home. received maintenance dialysis at home codes as in-center hemodialysis, making Information used to calculate the or in an ESRD facility, such that one it impossible for CMS to identify the Managing Clinician home dialysis rate beneficiary year is comprised of 12 relevant claims. We seek comment on includes Medicare claims data and beneficiary months. We would identify the identification and inclusion of these Medicare administrative data. months during which an attributed particular beneficiaries in the numerator We considered including beneficiaries ESRD Beneficiary received maintenance of the home dialysis rate calculation for whose dialysis modality is self-dialysis dialysis based on claims, specifically ESRD facilities. or temporary PD furnished in the ESRD claims with Type of Bill 072X, where facility at a transitional care unit in the (b) Home Dialysis Rate for Managing the type of facility code is 7 and the numerator, given that these modalities Clinicians type of care code is 2. Facility code 7 align with one of the overarching goals paired with type of care code 2, We propose that the denominator of of the proposed ETC Model, to increase indicates that the claim occurred at a the home dialysis rate for Managing beneficiary choice regarding ESRD clinic or hospital based ESRD facility, Clinicians would be the total dialysis treatment modality. However, these and the Type of Bill 072X captures all treatment beneficiary years for modalities lack clear definitions in the renal dialysis services furnished at or attributed ESRD beneficiaries during the literature and delivery of care for these through ESRD facilities. MY. Dialysis treatment beneficiary years modalities is billed through the same We propose that the numerator of the included in the denominator would be codes as in-center hemodialysis, making home dialysis rate for ESRD facilities composed of those months during it impossible for CMS to identify the would be the total number of dialysis which an attributed ESRD beneficiary relevant claims. We seek comment on treatment beneficiary years during the received maintenance dialysis at home the identification and inclusion of these MY in which attributed ESRD or in an ESRD facility, such that one particular beneficiaries in the numerator Beneficiaries received maintenance beneficiary year is comprised of 12 of the home dialysis rate calculation for dialysis at home. Home dialysis beneficiary months. We would identify Managing Clinicians. treatment beneficiary years included in maintenance dialysis months based on ® (2) Transplant Rate the numerator would be composed of claims, specifically claims with CPT those months during which attributed codes 90957, 90958, 90959, 90960, We propose to define the ‘‘transplant ESRD Beneficiaries received 90961, 90962, 90965, or 90966. CPT® rate’’ as the rate of ESRD Beneficiaries maintenance dialysis at home, such that codes 90957, 90958, 90959, 90960, and, if applicable, pre-emptive one beneficiary year is comprised of 12 90961, and 90962 are for ESRD-related transplant beneficiaries attributed to the beneficiary months. We would identify services furnished monthly, and ETC Participant who received a kidney maintenance dialysis at home months indicate beneficiary age (12–19 years of or kidney-pancreas transplant during based on claims, specifically claims age or 20 years of age and older) and the the MY, as described in proposed with Type of Bill 072X, where the type number of face-to-face visits with a § 512.365(c) (Transplant Rate). We of facility code is 7 and the type of care physician or other qualified health care propose to construct the transplant rate code is 2, with condition codes 74, 75, professional per month (1, 2–3, 4 or for ETC Participants that are ESRD 76, or 80. Facility code 7 paired with more). CPT® codes 90965 and 90966 are facilities as described in section type of care code 2, indicates that the for ESRD related services for home IV.C.5.c.(2)(a) of this proposed rule, and claim occurred at a clinic or hospital dialysis per full month, and indicate the for ETC Participants who are Managing based ESRD facility. Type of Bill 072X age of the beneficiary (12–19 years of Clinicians as described in section captures all renal dialysis services age or 20 years of age and older). Taken IV.C.5.c.(2)(b) of this proposed rule. furnished at or through ESRD facilities. together, these codes are used to bill the For purposes of constructing the Condition codes 74 and 75 indicate MCP for beneficiaries aged 18 or older, transplant rate, we propose two billing for a patient who received including patients who dialyze at home transplant rate-specific beneficiary dialysis services at home, and condition and patients who dialyze in-center. exclusions. Specifically, we propose to code 80 indicates billing for a patient The numerator for the home dialysis exclude an attributed beneficiary from who received dialysis services at home rate for Managing Clinicians would be the transplant rate calculations for any and the patient’s home is a nursing the total number of dialysis treatment months during which the beneficiary facility. Condition code 76 indicates beneficiary years during the MY in was 75 years of age or older at any point billing for a patient who dialyzes at which attributed ESRD Beneficiaries during the month, and for any months home but received back-up dialysis in a received maintenance dialysis at home. in which the beneficiary was in a skilled facility. Taken together, we believe Home dialysis treatment beneficiary nursing facility (SNF) at any point these condition codes capture home years included in the numerator would during the month. We propose these dialysis services furnished by ESRD be composed of those months during additional exclusions to recognize that, facilities. Information used to calculate which an attributed ESRD Beneficiary while these beneficiaries can be the ESRD facility home dialysis rate received maintenance dialysis at home, candidates for home dialysis, they are includes Medicare claims data and such that one beneficiary year is generally not considered candidates for Medicare administrative data. comprised of 12 beneficiary months. We transplantation. These exclusions would We considered including beneficiaries would identify maintenance dialysis at be similar to the exclusions used in the whose dialysis modality is self-dialysis home months based on claims, Percentage of Prevalent Patients or temporary PD furnished in the ESRD specifically claims with CPT® codes Waitlisted (PPPW) measure that has facility at a transitional care unit in the 90965 or 90966. CPT® code 90965 is for been adopted by ESRD QIP. We seek numerator, given that these modalities ESRD related services for home dialysis comment on the proposal to exclude align with one of the overarching goals per full month for patients 12–19 years from the transplant rate beneficiaries of the proposed ETC Model, to increase of age. CPT® code 90966 is for ESRD aged 75 or older and beneficiaries in

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SNFs. The transplant rate calculations adjustment aggregation methodology, syngeneic, open approach), 0TY00Z2 would also exclude beneficiaries who described in section IV.C.5.c.(4) of this (transplantation of right kidney, elected hospice, as we are proposing to proposed rule, would compensate for zooplastic, open approach) 0TY10Z0 exclude beneficiaries who have elected any lack of statistical power, and would (transplantation of left kidney, hospice from attribution generally under therefore eliminate the need to include allogeneic, open approach), 0TY10Z1 the ETC Model and therefore they data from calendar years prior to the MY (transplantation of left kidney, would be excluded from the calculation in order to produce a reliable and valid syngeneic, open approach), and of both the transplant rate and the home transplant rate. We solicit feedback on 0TY10Z2 (transplantation of left kidney, dialysis rate. our proposal to construct the transplant zooplastic, open approach). Because We considered using rates of rate using only one year of data, from kidney-pancreas transplants are billed transplant waitlisting rather than the the MY. by including an ICD–10 procedure code actual transplant rate. However, for the Also, we solicit comment on our for the type of kidney transplant and a ETC Model, we propose to test the proposed methodology for assessing separate ICD–10 procedure code for the effectiveness of the Model’s incentives transplant rates and alternative type of pancreas transplant, we on outcomes, rather than on processes. methodologies considered for assessing determined that we would not need to The relevant outcome for purposes of transplant rates. We discuss later in this include additional ICD–10 codes to the ETC Model is the receipt of a kidney rule our proposed plan for risk adjusting capture kidney-pancreas transplants or kidney-pancreas transplant, not and reliability adjusting these rates. beyond the ICD–10 codes for kidney getting on and remaining on the kidney (a) Transplant Rate for ESRD Facilities transplants listed. We propose that we transplant waitlist. While we would supplement Medicare claims acknowledge that getting a beneficiary For ESRD facilities, we propose that data on kidney and kidney-pancreas on the transplant waitlist is more the denominator for the transplant rate transplants with information from the directly influenced by the ESRD facility would be the total dialysis treatment SRTR Database and Medicare and/or the Managing Clinician than the beneficiary years for attributed ESRD administrative data about the beneficiary actually receiving the Beneficiaries during the MY, subject to occurrence of kidney and kidney- transplant, we believe that ESRD the aforementioned exclusions. Dialysis pancreas transplants not identified facilities and Managing Clinicians are treatment beneficiary years included in through claims. If a beneficiary who well positioned to assist beneficiaries the denominator would be composed of receives a transplant during a MY through the transplant process, and we those months during which attributed returns to dialysis during the same MY, want to incentivize this focus. ESRD Beneficiaries received the beneficiary would remain in the Transplant waitlist measures also do not maintenance dialysis at home or in an numerator. capture living donation, which is an ESRD facility, such that 1 beneficiary We also considered constructing the additional path to a successful kidney year would be comprised of 12 numerator for the ESRD facility transplant, and ESRD facilities and attributed beneficiary months. Months transplant rate such that the number of Managing Clinicians may support this during which an attributed ESRD attributed beneficiaries who received process. Details about the PPPW Beneficiary received maintenance transplants during a MY would remain Clinical Measure can be found in the CY dialysis would be identified by claims in the numerator for every MY after the 2019 ESRD PPS final rule (83 FR 56922, with Type of Bill 072X. Facility code 7 transplant during which the 57003–08). We solicit comment on our paired with type of care code 2, transplanted beneficiary does not return proposal to not test the effectiveness of indicates that the claim occurred at a to dialysis, for the duration of the the Model’s incentives on increasing the clinic or hospital based ESRD facility. proposed ETC Model. Keeping number of patients added to the kidney Type of Bill 072X captures all renal attributed beneficiaries who received transplant waitlist. Additionally, we dialysis services furnished at or through transplants in a MY in the numerator for solicit comment on an alternative ESRD facilities. However, in order to MYs subsequent to the MY in which the transplant waitlist measure that would effectuate the exclusions previously transplant occurs would acknowledge also capture living donation. described, we would exclude claims for the significant efforts made by ESRD We propose using one year of data, attributed ESRD Beneficiaries who were facilities to successfully assist from an MY, to construct the transplant 75 years of age or older at any point beneficiaries through the transplant rate to align with the construction of the during the month or were in a SNF at process. However, we believe this home dialysis rate. However, because any point during the month. approach would artificially inflate transplants are rare events for statistical We propose that the numerator for the transplant rates in later years of the purposes, we may not have sufficient transplant rate for ESRD facilities would Model and disproportionately statistical power to detect meaningful be the total number of attributed disadvantage new ESRD facilities who variation using only one year of beneficiaries who received a kidney begin providing care to ESRD performance information at the ETC transplant or a kidney-pancreas beneficiaries in later years of the Model. Participant level. In order to ensure that transplant during the MY. We would We concluded that this potential for we would have sufficient statistical identify kidney and kidney-pancreas artificially inflated rates and the power to detect meaningful variation in transplants using Medicare claims data, disadvantage that would result for new performance, we also considered the Medicare administrative data, and SRTR ESRD facilities outweighed the alternative of using 2, 3, or 4 years of data. For Medicare claims data, we advantage of accruing transplants over data, corresponding with the MY plus would use claims with Medicare time. We solicit comment on the the calendar year or years immediately Severity Diagnosis Related Groups (MS– inclusion of transplants in the prior to the MY, to construct the DRGs) 008 (simultaneous pancreas- numerator after the year of the transplant rate. However, we wanted to kidney transplant) and 652 (kidney transplant. avoid adjusting ETC Participant transplant); and claims with ICD–10 payment based on performance that procedure codes 0TY00Z0 (b) Transplant Rate for Managing occurred prior to the implementation of (transplantation of right kidney, Clinicians the ETC Model, if finalized, and allogeneic, open approach), 0TY00Z1 Whereas ESRD facilities provide care concluded that the proposed reliability (transplantation of right kidney, to beneficiaries only once they have

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begun dialysis, Managing Clinicians who dialyze at home and patients who for the type of kidney transplant and a provide care for beneficiaries before dialyze in-center. However, in order to separate ICD–10 procedure code for the they begin dialysis. Therefore, we effectuate the exclusions previously type of pancreas transplant, we propose to use a numerator and described, we would exclude claims for concluded that we would not need to denominator for the transplant rate for attributed ESRD Beneficiaries who were include additional ICD–10 codes to Managing Clinicians that would include 75 years of age or older at any point capture kidney-pancreas transplants pre-emptive transplant beneficiaries, during the month or were in a SNF at beyond the ICD–10 codes for kidney that is, beneficiaries who receive any point during the month. transplants listed. We propose that we transplants before beginning dialysis, in For pre-emptive transplant would supplement Medicare claims addition to ESRD Beneficiaries. In this beneficiaries, attributed beneficiary data on kidney and kidney-pancreas construction, a pre-emptive transplant years included in the denominator transplants with information from the beneficiary would be included in the would be composed of those months SRTR Database and Medicare numerator for the Managing Clinician as during which a pre-emptive transplant administrative data about the a transplant and in the denominator for beneficiary is attributed to the Managing occurrence of kidney and kidney- the Managing Clinician for the number Clinician, between the start of the MY pancreas transplants not identified of months from the beginning of the MY and the month of the transplant. We through claims. If a beneficiary who up to and including the month of the recognize that including pre-emptive receives a transplant during an MY transplant. We considered including transplant beneficiary years in the returns to dialysis during the same MY, pre-emptive transplants during the MY denominator may create a bias in favor the beneficiary would remain in the among attributed pre-emptive transplant of pre-emptive transplants occurring at numerator, to acknowledge the efforts of beneficiaries in the numerator, to the beginning of the MY, which may the Managing Clinician in facilitating acknowledge Managing Clinician efforts influence Managing Clinician behavior. the transplant but also to hold the in assisting ESRD beneficiaries with pre- As pre-emptive transplant beneficiaries Managing Clinician harmless for emptive transplants, without including only contribute months to the transplant failure, which may be outside them in the denominator. However, we denominator from the start of the MY to of the Managing Clinician’s control. concluded that this would the month of the transplant, the earlier We also considered constructing the disproportionately favor pre-emptive in the MY the transplant occurs, the numerator for the Managing Clinician transplants in the construction of the fewer months are included in the transplant rate such that the number of rate. We seek comment on the proposed denominator, and the higher the attributed beneficiaries who received inclusion of pre-emptive transplants in Managing Clinician’s transplant rate. transplants during a MY would remain both the numerator and the However, we believe that the potential in the numerator for every MY after the denominator for the Managing Clinician for this bias to impact Managing transplant for which the transplanted transplant rate calculation. Clinician behavior is small due to the beneficiary does not return to dialysis, complexity of scheduling in the pre- for the duration of the ETC Model. We propose that the denominator for emptive transplant process (such as Keeping transplants in the numerator the transplant rate for Managing surgeon availability, donor and for MYs subsequent to the MY in which Clinicians would be the total dialysis recipient schedules, etc.). the transplant occurs would treatment beneficiary years for We propose that the numerator for the acknowledge the significant efforts attributed ESRD Beneficiaries during the transplant rate for Managing Clinicians made by Managing Clinicians to MY, plus the total number of attributed would be the number of attributed ESRD successfully assist beneficiaries through beneficiary years for pre-emptive Beneficiaries who received a kidney the transplant process. However, we transplant beneficiaries during the MY. transplant or a kidney-pancreas believe this approach would artificially Dialysis treatment beneficiary years transplant during the MY, plus the inflate transplant rates in later years of included in the denominator would be number of pre-emptive transplant the Model and disproportionately composed of those months during beneficiaries attributed to the Managing disadvantage new Managing Clinicians which an attributed ESRD Beneficiary Clinician for the MY. We would identify who begin providing care to ESRD received maintenance dialysis at home kidney and kidney-pancreas transplants Beneficiaries in later years of the or in an ESRD facility, such that one using Medicare claims data, Medicare proposed Model. We concluded that beneficiary year is comprised of 12 administrative data, and SRTR data. For this potential for artificially inflated beneficiary months. Months during Medicare claims data, we would use rates and the disadvantage that would which an attributed ESRD Beneficiary claims with Medicare Severity result for new ESRD facilities received maintenance dialysis would be Diagnosis Related Groups (MS–DRGs) outweighed the advantage of accruing identified based on claims, specifically 008 (simultaneous pancreas-kidney ® transplants over time. We solicit claims with CPT codes 90957, 90958, transplant) and 652 (kidney transplant); comment on the inclusion of transplants 90959, 90960, 90961, 90962, 90965, or and claims with ICD–10 procedure ® in the numerator after the year of the 90966. CPT codes 90957, 90958, codes 0TY00Z0 (transplantation of right transplant. 90959, 90960, 90961, and 90962 are for kidney, allogeneic, open approach), ESRD related services monthly, and 0TY00Z1 (transplantation of right (3) Risk Adjustment indicate beneficiary age (12–19 or 20 kidney, syngeneic, open approach), In order to account for underlying years of age or older) and the number of 0TY00Z2 (transplantation of right variation in the population of face-to-face visits with a physician or kidney, zooplastic, open approach) beneficiaries attributed to participating other qualified health care professional 0TY10Z0 (transplantation of left kidney, ESRD facilities and Managing per month (1, 2–3, 4 or more). CPT® allogeneic, open approach), 0TY10Z1 Clinicians, we propose that CMS would codes 90965 and 90966 are for ESRD (transplantation of left kidney, risk adjust both the home dialysis rate related services for home dialysis per syngeneic, open approach), and and the transplant rate. full month, and indicate the age of the 0TY10Z2 (transplantation of left kidney, For the home dialysis rate, we beneficiary (12–19 or 20 years of age or zooplastic, open approach). Because propose to use the most recent final risk older). Taken together, these codes are kidney-pancreas transplants are billed score for the beneficiary, calculated used to bill the MCP, including patients by including an ICD–10 procedure code using the CMS–HCC (Hierarchical

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Condition Category) ESRD Dialysis to risk adjust the ETC Model home 2022 through June 30, 2022). CMS Model used for risk adjusting payment dialysis rate for that MY and adopted and announced the specific in the Medicare Advantage program, to corresponding PPA Period. CMS CMS–HCC ESRD Dialysis Model used risk adjust the home dialysis rate under proposes and adopts the CMS–HCC for payments for 2020 in the CY 2020 the proposed ETC Model. Internal ESRD Dialysis Model for risk adjusting Rate Announcement issued on April 1, analyses completed by CMS show that payments to Medicare Advantage 2019.132 lower HCC risk scores are associated organizations for a particular payment We believe that using risk scores with beneficiaries on home dialysis than year through the Advance Notice and developed using the CMS–HCC ESRD with beneficiaries on in-center HD. The Rate Announcement for the Medicare Dialysis Model to risk adjust the ETC risk adjustment methodology we are Advantage program.130 This happens Model home dialysis rate is appropriate proposing for the ETC Model home the year before the payment year begins, as it can be more difficult to transition dialysis rate would account for ESRD meaning that the CMS–HCC ESRD sicker beneficiaries to home dialysis, facilities and Managing Clinicians with Dialysis Model used to risk adjust and risk adjusting the home dialysis rate a population that is relatively sicker payments for 2020 was adopted and using risk scores calculated using the than the general Medicare population. announced in April 2019. However, CMS–HCC ESRD Dialysis Model would The CMS–HCC risk adjustment models CMS does not calculate final risk scores account for the relative sickness of the were developed for the Medicare for a particular payment year until population of ESRD Beneficiaries Advantage program and uses a Medicare several months after the close of the attributed to each ETC Participant beneficiary’s medical conditions and payment year. relative to the national benchmark. demographic information to predict For MY 1 (January 1, 2020 through Moreover, use of the final risk scores as Medicare expenditures for the next year. December 31, 2020), which corresponds we are proposing means that the ETC In the Medicare Advantage context, the to PPA Period 1 (July 1, 2021 through Model would follow the same per-person capitation amount paid to December 31, 2021), we are proposing methodology and use the same each Medicare Advantage plan is in section IV.C.5.g of this proposed rule coefficients for the relevant HCCs as the adjusted using a risk score calculated that CMS would notify ETC Participants CMS–HCC ESRD Dialysis Model used using the CMS–HCC Models.129 There of their PPA no later than June 1, 2021. for the prior Medicare Advantage are various CMS–HCC Models used in The calculation of the PPA and payment year. The CMS–HCC ESRD the Medicare Advantage program, all of component risk-adjusted home dialysis Dialysis Model includes the risk factors which are developed using cost and rate would occur in May 2021. As the outlined in § 422.308(c)(1) and (2)(ii), so diagnoses from claims data from the final risk scores for payment year 2020 those risk factors would be used in risk Medicare FFS program, including would not be calculated for purposes of adjustment for the ETC Model; the risk models specific to calculating risk the Medicare Advantage program until scores used for the ETC Model would scores for enrollees with ESRD. Under 2021, we are proposing that CMS would also be adjusted with the same coding the CMS–HCC Models, the risk factors— use the final risk scores calculated by pattern and normalization factors that meaning the demographic factors and CMS for 2019, which will happen in are adopted for the CMS–HCC ESRD conditions (as represented by HCCs)— 2020 using the CMS–HCC ESRD Dialysis Model for the relevant year. have a coefficient that represents the Dialysis Model adopted for risk However, for the ETC Model, there amount of risk projected to be adjustment of payments for payment would not be a frailty adjustment (for associated with and is unique to the year 2019 to risk adjust the home example, outlined in § 422.308(c)(4)) condition or demographic status. A dialysis rates for MY 1/PPA Period 1. that is used in the Medicare Advantage relative factor is created for each CMS adopted and announced the program for certain special needs plans. demographic and condition variable by specific CMS–HCC ESRD Dialysis We also considered not applying a dividing the coefficient by the average Model used for payments for 2019 in the risk adjustment methodology to the ETC annual cost of a FFS beneficiary CY 2019 Rate Announcement issued in Model home dialysis rate in recognition 131 predicted by the model in a April 2018. We are further proposing of the limitations of existing risk denominator year. For payment, CMS that CMS would use the final risk scores adjustment methodologies to account calculates a risk score for each enrollee calculated by CMS in 2021, using the for housing instability, which is a key by adding the relative factors of an CMS–HCC ESRD Dialysis Model factor preventing utilization of home enrollee’s demographics and health adopted for risk adjustment of payments dialysis. However, we concluded that status (that is, HCCs). CMS then for 2020, to risk adjust the home dialysis not risk adjusting the home dialysis rate multiplies the resulting risk score (after rates for MY 2 (July 1, 2020 through would disproportionately disadvantage some adjustments are applied) by the June 30, 2021)/PPA Period 2 (January 1, ETC Participants that provide care to monthly capitation amount to pay the sicker beneficiaries. Medicare Advantage plan risk 130 For example, CMS, Advance Notice of Methodological Changes for Calendar Year (CY) We also considered creating a custom adjustment. CMS has developed a 2020 for Medicare Advantage (MA) Capitation risk-adjustment methodology for the separate CMS–HCC ESRD Model for Rates, Part C and Part D Payment Policies and 2020 ETC Model based on certain factors beneficiaries who are on dialysis, who Draft Call Letter, January 30, 2019. cms.gov/ found in the literature to affect rates of have received kidney transplants, or Medicare/Health-Plans/MedicareAdvtgSpec RateStats/Downloads/Advance2020Part2.pdf and home dialysis. However, we believe that who are in post-graft status. CMS, Announcement of Calendar Year (CY) 2020 the HCC system for risk adjustment We propose to use the most recent Medicare Advantage Capitation Rates and Medicare currently in use in the Medicare final risk score calculated for the Advantage and Part D Payment Policies and Final Advantage program would be sufficient beneficiary that is available at the time Call Letter, April 1, 2019; https://www.cms.gov/ for the purposes of this Model, without of the calculation of ESRD facility and Medicare/Health-Plans/MedicareAdvtgSpecRate Stats/Downloads/Announcement2020.pdf. Managing Clinician home dialysis rates 131 For the CY2019 Advance Notice and Rate 132 (CY) 2020 Medicare Advantage Capitation Announcement, specifying the CMS–HCC ESRD Rates and Medicare Advantage and Part D Payment 129 CMS. Report to Congress: Risk adjustment in Dialysis Model used for payment in 2019, see: Policies and Final Call Letter, April 1, 2019; https:// Medicare Advantage. December 2018; cms.gov/ https://www.cms.gov/Medicare/Health-Plans/ www.cms.gov/Medicare/Health-Plans/ Medicare/Health-Plans/MedicareAdvtgSpec MedicareAdvtgSpecRateStats/Announcements-and- MedicareAdvtgSpecRateStats/Downloads/ RateStats/Downloads/RTC-Dec2018.pdf. Documents.html. Announcement2020.pdf.

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the effort required to develop a new the population of beneficiaries rate and transplant rate among the ETC methodology. attributed to each ETC Participant in Participant’s aggregation group We propose that the risk-adjustment each age category relative to the national (previously described), with the relative methodologies for the home dialysis rate age distribution of beneficiaries not weights of the two components based on and transplant rate would be applied excluded from attribution. Further the statistical reliability of the independently. We considered using the information on the risk adjustment individual ETC Participant’s home same risk adjustment strategy for both model used for purposes of the PPPW dialysis rate and transplant rate, as rates, however, we recognize that the can be found in the PPPW Methodology applicable. For example, if an ETC risk factors that may impact the ability Report (https://www.cms.gov/Medicare/ Participant’s home dialysis rate has high of an ESRD Beneficiary to successfully Quality-Initiatives-Patient-Assessment- statistical reliability, then the ETC dialyze at home are different from the Instruments/ESRDQIP/Downloads/ Participant’s individual home dialysis risk factors that may impact the ability Report-for-Percentage-of-Prevalent- rate would contribute a large portion of of an ESRD Beneficiary or pre-emptive Patients-Waitlisted.pdf). the ETC Participant’s reliability- transplant beneficiary to receive a We considered using the risk adjusted home dialysis rate and the kidney transplant. Further, even in the adjustment methodology used in the aggregation group’s home dialysis rate Medicare Advantage program, a Standardized Waitlist Ratio available would contribute a small portion of the different CMS–HCC Model is used for online at https://www.cms.gov/ ETC Participant’s reliability-adjusted beneficiaries who have received a Medicare/Quality-Initiatives-Patient- home dialysis rate. We currently employ transplant. We believe that the benefit of Assessment-Instruments/ESRDQIP/ this technique in a variety of settings, separate risk adjustment methodologies Downloads/Report-for-Standardized- including the measures used in creating outweighs the additional complexity. First-Kidney-Transplant-Waitlist-Ratio- hospital ratings for Hospital Compare. For the proposed ETC Model for-Incident-Dialysis-Facilities.pdf for The advantage of using this approach is transplant rate, we wanted to use a risk risk adjusting the ETC Model transplant that we could use one method to adjustment methodology that aligns rate. However, we decided not to as this produce comparable performance rates with a risk adjustment methodology measure is focused only on incident for ESRD facilities and Managing with which ESRD facilities and beneficiaries in their first year of Clinicians across the size spectrum. The Managing Clinicians are likely to be dialysis, rather than the broader disadvantage of using this approach is familiar and that similarly would not population of beneficiaries that would that reliability adjusted performance require development of a new and be included in the ETC Model. rankings do not necessarily reflect unfamiliar methodology. We believe We considered using the CMS–HCC absolute or observed performance, and that the methodology used for purposes ESRD Transplant Model for risk may be difficult to interpret directly. of risk adjusting the PPPW satisfies adjusting the ETC Model transplant rate. However, we believe this approach these criteria and would be appropriate However, we decided not to as the balances the need for individualized to apply in risk adjusting the transplant model is focused on costs once a performance assessment and incentives rate. Specifically, we propose that the beneficiary receives a transplant, rather with the importance of reliably ESRD facility and Managing Clinician than their suitability for receiving a assessing the performance of each ETC transplant rates would be risk adjusted transplant. Participant. for beneficiary age, using the similar age We solicit comment on the proposed categories, with corresponding risk risk adjustment methodologies and the For Managing Clinicians, we propose coefficients, used for purposes of the alternatives considered. that the performance on these measures PPPW measure described earlier (83 FR would first be aggregated up to the (4) Reliability Adjustments and practice level, as identified by the 57004). Aggregation Although age alone is not a practice Taxpayer Identification contraindication to transplantation, In order to overcome low reliability of Number (TIN) for Managing Clinicians older patients are likely to have more the home dialysis rate and transplant who are in a group practice, and at the comorbidities and generally be more rate related to small numbers of individual National Provider Identifier frail, thus making them potentially less beneficiaries attributed to individual (NPI) level for Managing Clinicians who suitable candidates for transplantation, ETC Participants, we propose to employ are not in a group practice, that is, solo and therefore some may be a reliability adjustment. Under this practitioners. We propose to define appropriately excluded from waitlisting approach, we propose using statistical ‘‘TIN’’ as a Federal taxpayer for transplantation. The risk adjustment modeling to make reliability identification number or employer model for the PPPW contains risk adjustments such that the home dialysis identification number as defined by the coefficients specific to each of the rate and the transplant rate would Internal Revenue Service in 26 CFR following age categories of beneficiaries produce reliable estimates for all ETC 301.6109–1. We propose to define (with age computed on the last day of Participants, regardless of the number of ‘‘NPI’’ as the standard unique health each reporting month): Under 15; 15–55; beneficiaries for whom they provide identifier used by health care providers 56–70; and 71–74. Given that the care. We also propose this approach to for billing payers assigned by the proposed ETC Model would exclude improve comparisons between ETC National Plan and Provider beneficiaries under 18 from the Participants and those ESRD facilities Enumeration System (NPPES) in 45 CFR attribution methodology used for and Managing Clinicians not selected part 162. We propose these definitions purposes of calculating the transplant for participation in the Model for because they are used elsewhere by the rates, we propose to use the risk purposes of achievement benchmarking Medicare program (see 42 CFR 414.502). coefficients calculated for the PPPW for and scoring, described in section Performance would then be aggregated the populations aged 18–55, 56–70, and IV.C.5.d of this proposed rule. The to the aggregation group level. We 71–74, with age computed on the last proposed reliability adjustment propose that the aggregation group for day of each month of the MY. approach would create a weighted Managing Clinicians, once aggregated to Transplant rates for ESRD facilities and average between the individual ETC the group practice or solo practitioner Managing Clinicians would be adjusted Participant’s home dialysis rate and level, as applicable, would be all to account for the relative percentage of transplant rate and the home dialysis Managing Clinicians within the HRR in

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which the group practice is located (for attributed beneficiaries. We seek public areas. By MY 9 and MY 10, in order to group practices) or the Managing comment on our proposal to address receive the maximum achievement Clinician’s HRR (for solo practitioners). this facet of the provision of home score, we are considering that an ETC For ESRD facilities, we propose that dialysis in the larger dialysis market Participant would have to have a the individual unit would be the ESRD through the reliability adjustment as combined home dialysis rate and facility. We propose to define a well as the alternatives considered. transplant rate equivalent to 80 percent subsidiary ESRD facility as an ESRD d. Benchmarking and Scoring of attributed beneficiaries dialyzing at facility owned in whole or in part by home and/or having received a another legal entity. We propose this We propose calculating two types of transplant. We seek public comment on definition in recognition of the structure benchmarks for rates of home dialysis our intent to increase achievement of the dialysis market, as described in and transplants against which to assess benchmarks over the duration of the this rule. We propose that the ETC Participant performance in MY 1 Model. aggregation group for subsidiary ESRD and MY 2 (both of which begin in CY facilities would be all ESRD facilities 2020). Risk-adjusted and reliability- The second set of benchmarks would located within the ESRD facility’s HRR adjusted ETC Participant performance be used in calculating an improvement owned in whole or in part by the same for the home dialysis rate and the score for the ETC Participant on both company, and that ESRD facilities that transplant rate would be assessed the home dialysis rate and the are not subsidiary ESRD facilities would against these benchmarks on both transplant rate. This set of benchmarks be in an aggregation group with all other achievement and improvement at the would be constructed based on ESRD facilities located within the same ETC Participant level. historical rates of home dialysis and HRR (with the exception of those ESRD The first set of benchmarks would be transplants by the ETC Participant facilities that are subsidiary ESRD used in calculating an achievement during the benchmark year. We propose facilities). score for the ETC Participant on both to calculate the improvement score by We seek input on our proposal to use the home dialysis rate and the comparing MY performance on the reliability adjustments to address transplant rate. This set of benchmarks home dialysis rate and transplant rate reliability issues related to small would be constructed based on against past ETC Participant numbers, as well as on our proposed historical rates of home dialysis and performance to acknowledge efforts aggregation groups for conducting the transplants in comparison geographic made in practice transformation to reliability adjustment for ESRD facilities areas. We propose constructing the improve rates of home dialysis and and Managing Clinicians that are ETC benchmarks using 12 months of data, transplants. However, we propose that Participants. beginning 18 months before the start of an ETC Participant cannot attain the We acknowledge that for some the MY and ending 6 months before the highest scoring level through segments of the dialysis market, start of the MY, to allow time for claims improvement scoring. Specifically, companies operating ESRD facilities run-out and calculation. We propose to while an ETC Participant could earn an may operate specific ESRD facilities that refer to this period of time as the achievement score of up to 2 points for focus on home dialysis, which furnish ‘‘benchmark year.’’ We propose using the transplant rate and the home home dialysis services to all patients data from ESRD facilities and Managing dialysis rate, the maximum possible receiving home dialysis through that Clinicians located in comparison improvement score is 1.5 points for each company in a given area. Therefore, geographic areas to construct these of the rates. This policy would be assessing home dialysis rates at the benchmarks. As an alternative, we consistent with other CMS programs individual ESRD facility level may not considered using national performance and initiatives employing similar accurately reflect access to home rates to construct these benchmarks. improvement scoring methodologies, dialysis for beneficiaries receiving care However, in order to prevent the impact including the CEC Model. from a specific company in the area. We of the model intervention altering believe that the reliability adjustment benchmarks for subsequent MYs, we We considered not including approach would help to address this decided against this alternative. We improvement scoring for the first two concern, because the construction of the propose to calculate the home dialysis MYs, as this would mean assessing reliability adjustment for subsidiary rate and transplant rate benchmarks for improvement in the MY against ETC ESRD facilities would aggregate to the ESRD facilities and Managing Clinicians Participant performance before the ETC company level within a given HRR and located in comparison geographic areas Model would begin. However, we thus incorporate this dynamic. We during the benchmark year using the believe that including improvement considered using a single aggregated same methodologies that we use to scoring for the first two MYs is home dialysis rate for all ESRD facilities calculate the home dialysis rate and appropriate, as it acknowledges owned in whole or in part by the same transplant rate for ESRD facilities and performance improvement gains while company within a given HRR to account Managing Clinicians located in selected participating in the ETC Model. We seek for this market dynamic. However, we geographic areas during the MYs. We input on the use of improvement concluded that producing individual intend to establish the benchmarking scoring in assessing ETC Participant ESRD facility rates and reliability methodology for future MYs through performance for the first two MYs. Table adjusting individual ESRD facility subsequent rulemaking. 13 details the proposed scoring scores would be necessary to incentivize Our intent in future MYs is to methodology for assessment of MY 1 ESRD facilities within the same increase achievement benchmarks and MY 2 achievement scores and company in the same HRR to provide among ETC Participants above the rates improvement scores on the home the same level of care to all of their observed in comparison geographic dialysis rate and transplant rate.

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Under our proposal, the ETC higher of the achievement score or Performance Score (MPS). We propose Participant would receive the higher of improvement score for the transplant the following formula for determining the achievement score or improvement rate, which would be combined to the MPS: score for the home dialysis rate and the produce the ETC Participant’s Modality

We propose that the home dialysis e. Performance Payment Adjustments adjustments proposed for the ETC rate score would constitute two thirds of We propose that CMS would make Model would start at the same 5 percent the MPS, and that the transplant rate upwards and downwards adjustments to level in 2020 as the MIPS payment score would constitute one third of the payments for claims for dialysis and adjustment at 42 CFR 414.1405(c). The MPS. We considered making the home dialysis-related services, described in PPAs proposed for the ETC Model are dialysis rate score and the transplant IV.C.5.e of this proposed rule, submitted also designed to increase over time and rate score equal components of the MPS, by each ETC Participant with a claim to be asymmetrical—with larger to emphasize the importance of both through date during the applicable PPA negative adjustments than positive home dialysis and transplants as period based on the ETC Participant’s adjustments—in order to create stronger alternative renal replacement therapy PPA. We propose that the magnitude of financial incentives. modalities. However, we recognize that the potential positive and negative CMS believes that downside risk is a transplant rates may be more difficult payment adjustments would increase critical component of this Model in for ETC Participants to improve than over the PPA Periods of the ETC Model. order to create strong incentives for home dialysis rates, due to the limited The magnitude of the proposed PPAs behavioral change among ETC supply of organs and the number of are designed to be comparable to the Participants. We are proposing that the other providers and suppliers that are MIPS payment adjustment factors for negative adjustments would be greater part of the transplant process but are not MIPS eligible clinicians, as described in for ESRD facilities than for Managing included as participants in the ETC sections IV.C.5.e.(1) and IV.C.5.e.(2) of Clinicians, in recognition of the ESRD Model. For this reason, we are this proposed rule. Specifically, the facilities’ larger size and ability to bear proposing that the home dialysis rate proposed PPAs are designed to be downside financial risk relative to component take a greater weight than substantial enough to incentivize individual clinicians. We believe that the transplant rate component of the appropriate behavior without overly the proposed exclusion of ESRD MPS. We request comment on the harming ETC Participants through facilities that fall below the low-volume proposed MPS calculation. reduced payments. The payment threshold described in section

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IV.C.5.f.(1) of this proposed rule would Adjusted ESRD PPS per Treatment Base based ESRD facility. Type of Bill 072X ensure that only those ESRD facilities Rate for claim lines with Type of Bill therefore captures all renal dialysis with the financial capacity to bear 072x, where the type of facility code is services furnished at or through ESRD downside risk would be subject to 7 and the type of care code is 2, and for facilities. As with the HDPA, we application of the Facility PPA. which the beneficiary is 18 or older for propose to apply the Facility PPA to the entire month and where the claim (1) Facility PPA claims where Medicare is the secondary through date is during the applicable payer. We see comment on this For ESRD facilities that are ETC PPA Period as described in proposed proposal. Participants, as described in proposed § 512.355(c) (Measurement Years and § 512.325(a) (Selected Participants), we Performance Payment Adjustment The formula for determining the final propose to adjust certain payments for Periods). Facility code 7 paired with ESRD PPS per treatment payment renal dialysis services by the Facility type of care code 2 indicates that the amount with the Facility PPA would be PPA. Specifically, we would adjust the claim occurred at a clinic or hospital as follows:

For time periods and claim lines for Facility PPA apply, the formula for treatment payment amount would be as which both the Facility HDPA and the determining the final ESRD PPS per follows:

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

As also described in section IV.C.7.a be based on the amount that would have (2) Clinician PPA of this proposed rule, we further been paid under the ESRD PPS absent For Managing Clinicians that are ETC propose that the Facility PPA would not the Facility PPA. Participants, as described in proposed affect beneficiary cost sharing. § 512.325(a) (Selected Participants), we Beneficiary cost sharing would instead propose to adjust payments for

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

We propose to adjust the amount months from multiple beneficiaries. We volume exclusion would ensure that we otherwise paid under Part B by the are proposing this exclusion threshold would be adjusting payment based on Clinician PPA so that beneficiary cost to increase statistical reliability and to reliable measurement of Managing sharing would not be affected by the exclude low-volume ESRD facilities Clinician performance. Managing application of the Clinician PPA. The from the application of the Facility PPA. Clinicians with sufficiently small Clinician PPA would apply only to the We selected this particular threshold attributed beneficiary populations may amount otherwise paid for the MCP because it is similar to the 11 qualifying serve unique patient populations, such absent the Clinician PPA. patient minimum threshold that the as children, such that we may not be We seek comment on our PPA ESRD QIP uses for purposes of scoring able to produce statistically reliable proposals, including the proposed certain measures during the transplant rates and home dialysis rates magnitude of and schedule for these performance period. We considered for these Managing Clinicians. We proposed payment adjustments for both using the 11 qualifying patients propose that the low-volume threshold ESRD facilities and Managing Clinicians threshold used for purposes of scoring would be set at the bottom five percent participating in the ETC Model. some measures under the ESRD QIP, but of ETC Participants who are Managing f. Low-Volume Threshold Exclusions for due to differences in beneficiary Clinicians in terms of the number of the PPA attribution methodologies between the beneficiary-years for which the ESRD QIP and the proposed ETC Model, Managing Clinician billed the MCP (1) ESRD Facilities we concluded that using beneficiary- during the MY. We considered using 11 We propose excluding ETC years was more appropriate for purposes beneficiary-years as the low-volume Participants that are ESRD facilities that of testing the ETC Model, as the rates exclusion for Managing Clinicians, to have fewer than 11 attributed proposed for the ETC Model are based mirror the proposed exclusion for ESRD beneficiary-years during a given MY on beneficiary-years. facilities. However, we recognize that from the application of the PPA during We invite public comment on this ESRD facilities and Managing Clinicians the corresponding PPA Period. Each proposal for excluding ESRD facilities are different in that Managing Clinicians beneficiary-year would be equivalent to with fewer than 11 attributed are more diverse, as compared to ESRD 12 attributed beneficiary months, where beneficiary-years from the application of facilities, in terms of both volume of a beneficiary month is one calendar the PPA during the applicable PPA services furnished to beneficiaries month for which an ESRD beneficiary is Period, as well as the alternatives related to receiving dialysis and services attributed to an ETC Participant using considered. furnished that are not related to dialysis. the attribution methodology described Therefore, we propose using a at IV.C.5.b, meaning that an ESRD (2) Managing Clinicians percentile-based low-volume exclusion facility must have at least 132 total We propose excluding ETC threshold for Managing Clinicians that attributed beneficiary months for a MY Participants that are Managing would help to ensure statistical in order to be subject to the PPA for the Clinicians who fall below a specified soundness while recognizing the corresponding PPA period. Under our low-volume threshold during an MY diversity of the Managing Clinician proposal, a beneficiary year could be from the application of the PPA during population. In the alternative, we comprised of attributed beneficiary the corresponding PPA Period. The low- considered establishing the low-volume

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threshold based on the bottom five not involve the calculation of the MPS), potentially result in the closure of the percent of Managing Clinicians who are then the ETC Participant should targeted review request. If we were to ETC Participants in the total dollar continue to use the standard CMS find, after conducted a targeted review, value of Medicare claims paid. procedures through their Medicare that there had been an error in the However, as Managing Clinicians are in Administrative Contractor. Section 1869 calculation of the ETC Participant’s a variety of specialties and provide a of the Act provides for a process for MPS, we would notify the ETC wide range of services that are paid at Medicare beneficiaries, providers, and Participant within 30 days of the a variety of rates, we concluded that a suppliers to appeal certain claims and finding. If the error in the MPS were dollar-value threshold was not suitable decisions made by CMS. such that it caused us to apply an for purposes of this proposed exclusion. We propose that ETC Participants incorrect PPA during the PPA period We invite public comment on this would be able to request a targeted associated with the incorrect MPS, we proposal for excluding certain Managing review of the calculation of their MPS. would notify the ETC Participant and Clinicians from the application of the ETC Participants would be able to resolve the payment discrepancy during PPA during the applicable PPA Period request a targeted review for certain the next PPA period following based on our proposed low-volume considerations, including, but not notification of the MPS error. Decisions threshold, as well as the alternatives limited to, when: The ETC Participant based on the targeted review process considered. believes there to have occurred an error would be final, and there would be no in the home dialysis rate or transplant g. Notification further review or appeal. rate used in the calculation of the MPS We considered compressing the Per the PPA schedule, we propose due to data quality or other issues; or duration of the targeted review process that payment adjustments would be the ETC Participant believes that there such that it could be completed before made during the PPA period that begins are certain errors, such as the PPA period in which the MPS in 6 months after the end of the MY. This misapplication of the home dialysis rate question sets the PPA. However, we 6-month period would allow for three or transplant rate benchmark in believe that this would be an months claims run-out to account for lag determining the ETC Participant’s insufficient amount of time for ETC in claims processing, and for CMS to achievement score, improvement score, Participants to review their MPS, calculate and validate the MPS and the or the selection of the higher score for consider the possibility of a calculation corresponding PPA for each ETC use in the MPS. The targeted review or data error, request a targeted review, Participant. After we calculate ETC process would be subject to the and provide additional information to Participant MPSs and PPAs, we propose limitations on administrative and CMS if requested. to notify ETC Participants of their judicial review as previously described. We invite public comment on these attributed beneficiaries, MPSs and Specifically, an ETC Participant could proposed provisions regarding the corresponding PPAs. We propose not use the targeted review process to proposed targeted review process. notification of ETC Participants no later dispute a determination that is than one month before the start of the 6. Overlap With Other Innovation precluded from administrative and Center Models and CMS Programs PPA Period in which the PPA would go judicial review under section into effect. We believe this notification 1115A(d)(2) of the Act and proposed The ETC Model would overlap with period balances the need for sufficient § 512.170. several other CMS programs and claims run-out to ensure accuracy, as To request a targeted review, the ETC models, and we seek comment on our well as sufficient time for MPA and PPA Participant would provide written proposals to account for overlap: calculation and validation by CMS, with notice to CMS of a suspected error in • ESRD Quality Incentive Program our interest in providing sufficient the calculation of their MPS no later (ESRD QIP)—The ESRD QIP reduces advanced notification regarding the than 60 days after we notify ETC payment to a facility under the ESRD resulting payment adjustments to ETC participants of their MPS, or at a later PPS for a calendar year by up to 2 Participants. date as specified by CMS. We propose percent if the facility does not meet or We propose to conduct notifications that this written notice must be exceed the total performance score in a form and manner determined by submitted in a form and manner established by CMS for the CMS. specified by CMS. The ETC Participant corresponding ESRD QIP payment year would be able to include additional with respect to measures specified for h. Targeted Review information in support of its request for that payment year. We propose that the We believe that it would be advisable targeted review at the time the request ETC Model’s Facility HDPA and Facility to provide a process according to which is submitted. PPA would be applied prior to the an ETC Participant would be able to We propose that we will respond to application of the ESRD QIP payment dispute errors that it believe to have each request for targeted review adjustment to the ESRD PPS per occurred in the calculation of the MPS. submitted in writing in a timely treatment payment amount, as we are Therefore, we are proposing a policy manner, and determine within 60 days proposing that the Facility HDPA and that would permit ETC Participants to of receipt of the request whether a the Facility PPA would adjust the contest errors found in their MPS, but targeted review is warranted. We Adjusted ESRD PPS per Treatment Base not in the ETC Model home dialysis rate propose that we would either accept or Rate, as previously discussed at section calculation methodology, transplant rate deny the request for targeted review, or IV.C.4.b of this proposed rule. calculation methodology, achievement request additional information from the • Merit-based Incentive Payment and improvement benchmarking ETC Participant that we would deem System (MIPS)—Under section methodology, or MPS calculation necessary to make such a decision. If we 1848(q)(6) of the Act and 42 CFR methodology. We note that, if ETC were to request additional information 414.1405(e), the MIPS payment Participants have Medicare FFS claims from the ETC Participant, it would be adjustment factor, and, as applicable, or decisions they wish to appeal (that is, required to be provided and received the additional MIPS payment Medicare FFS issues experienced by the within 30 days of the request. Non- adjustment factor (collectively referred ETC Participant that occur during their responsiveness to the request for to as the MIPS payment adjustment participation in the ETC Model that do additional information would factors) generally apply to the amount

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otherwise paid under Medicare Part B CKCC Models. Kidney transplants Next Generation ACO Model, that focus with respect to covered professional represent the most desired and cost on total cost of care, we propose that services furnished by a MIPS eligible effective treatment for most any increase or decrease in program clinician during the applicable MIPS beneficiaries with ESRD, but providers expenditures that are due to the ETC payment year. We propose that the and suppliers may currently have Model would be counted as program Clinician HDPA and the Clinician PPA insufficient financial incentives to assist expenditures to ensure that the in the ETC Model would similarly apply beneficiaries through the transplant Medicare APM continues to measure the to the amount otherwise paid under process because dialysis generally total cost of care to the Medicare Medicare Part B, but would occur prior results in higher reimbursement over a program. The Medicare Shared Savings to the application of the MIPS payment more extended period of time than a Program regulations include a policy for adjustment factors. This is designed to transplant.133 As a result, CMS believes addressing payments under a model, ensure that the MIPS payment it would be appropriate to test demonstration, or other time-limited adjustment factors will still have a incentives in both the ETC Model and program. Specifically, in conducting significant weight for Managing the KCF and CKCC Models payment reconciliation for the Shared Clinicians. simultaneously to assess their effects on Savings Program, CMS considers • the transplant rate. ‘‘individually beneficiary identifiable Kidney Care First Model (KCF) and • the Comprehensive Kidney Care Comprehensive ESRD Care (CEC) final payments made under a Contracting (CKCC) Model—The KCF Model—The CEC Model is a voluntary demonstration, pilot, or time limited and CKCC Modela are optional Innovation Center model for ESRD program’’ (see, for example, dialysis facilities, nephrologists, and Innovation Center models for § 426.610(a)(6)(ii)(B)). We believe that other providers and suppliers that nephrologists, dialysis facilities, this existing policy sufficiently focuses on beneficiaries with ESRD. The transplant providers, and other addresses overlaps that would arise CEC Model will end on December 31, providers and suppliers that are focused between the Medicare Shared Savings 2020, and therefore, would overlap for on beneficiaries with CKD and Program and the proposed ETC Model. one year with the proposed ETC Model. beneficiaries with ESRD. The KCF and CMS would review any models where We propose that ETC Participants could CKCC Models will run from January 1, this form of reconciliation may not be be selected from regions where there are 2020, through December 31, 2025, and possible and make an assessment as to participants in the CEC Model. Given will have five years of financial what changes, if any, may be necessary the national distribution of CEC ESCOs, accountability overlap with the ETC to account for the effects of testing the we do not believe the overlap between ETC Model. We seek public input on Model beginning January 1, 2021. We the two Models would impact the propose that the types of entities eligible our proposed overlap policies. validity of the ETC Model test, as ESCOs We invite public comments on our to participate in these models -KCF would be equally likely to be located in proposals to account for overlaps with practices and Kidney Contracting selected geographic areas as in other CMS programs and models. Entities (KCEs)—would be permitted to comparison geographic areas, creating a participate in either the KCF or one of net neutral effect. We do not believe that 7. Medicare Program Waivers the CKCC Models within regions where the proposed ETC Model would We believe it is necessary and the ETC Model would be in effect. Not significantly affect the CEC Model appropriate to provide additional allowing these entities to participate as because the payment incentives under flexibilities to ETC Participants for KCF practices or KCEs within the ETC the ETC Model would be smaller in purposes of testing the ETC Model. The Model’s selected geographic areas 2020 when the CEC Model is active and purpose of such flexibilities would be to would limit participation in the KCF because the CEC Model is focused on give ETC Participants additional access and CKCC Models, and could prevent a total cost of care, the majority of which to the tools necessary to ensure ESRD sufficient number of KCF practices or is non-dialysis care. Not allowing CEC Beneficiaries can select their preferred KCEs from participating in the KCF and ESCOs to participate in the CEC Model treatment modality, resulting in better, KCCC Models, such that these models within the ETC Model’s selected more coordinated care for beneficiaries would not have sufficient participation geographic areas would require either and improved financial efficiencies for to be evaluated. CMS believes it is terminating ESCOs that participate in Medicare, providers, suppliers, and important to test both models in order the CEC Model in the ETC Model’s beneficiaries. to evaluate payment incentives inside selected geographic areas, which we We propose to implement these and outside the coordinated care believe would negatively impact the flexibilities using our waiver authority context. The ETC Model would allow CEC Model test by requiring termination under section 1115A of the Act. Section for a broader scope of test due to its of several ESCOs, or altering ETC Model 1115A(d)(1) of the Act provides mandatory nature across half the randomization to exclude regions in authority for the Secretary to waive such country, while the KCF and CKCC which CEC ESCOs are participating in requirements of title XVIII of the Act as Model will test the effects on outcomes the CEC Model, which we believe may be necessary solely for purposes of of higher levels of risk for a self-selected would negatively impact the ETC Model carrying out section 1115A of the Act group of participants. Payment by interfering with the proposed with respect to testing models described adjustments under the ETC Model randomization. in section 1115A(b) of the Act. This would be counted as expenditures for • All other Medicare APMs—For provision affords broad authority for the purposes of the KCF and CKCC Models. other Medicare APMs, such as the Secretary to waive Medicare program Both models would include explicit Medicare Shared Savings Program or the requirements as necessary to test models incentives for participants when under section 1115A of the Act. beneficiaries receive kidney transplants; 133 Abecassis M, Bartlett ST, Collins AJ, Davis CL, and a participant in both models would Delmonico FL, Friedewald JJ et al. Kidney a. Medicare Payment Waivers be eligible to receive both types of transplantation as primary therapy for end-stage In order to make the proposed renal disease: a National Kidney Foundation/ adjustments under the ETC Model (the Kidney Disease Outcomes Quality Initiative (NKF/ payment adjustments under the ETC HDPA and PPA), as well as a Kidney KDOQITM) conference. Clinical Journal of the Model, namely the HDPA and PPA Transplant Bonus under the KCF and American Society of Nephrology. 2008;3(2):471–80. discussed in sections IV.C.4 and IV.C.5

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of this proposed rule, respectively, we implementing regulation at 42 CFR ESRD facility conditions for coverage at believe we would need to waive certain 410.48. Medicare currently covers up to § 494.70(a)(7); and to develop and Medicare program rules. 6, 1-hour sessions of KDE services for implement a plan of care that addresses Therefore, in accordance with the beneficiaries that have Stage IV CKD. the patient’s modality of care, at authority granted to the Secretary in While the KDE benefit is designed to § 494.90(a)(7). section 1115A(d)(1) of the Act, we educate and inform beneficiaries about • KDE is now covered only for would waive requirements of the Act for the effects of kidney disease, their Medicare beneficiaries with Stage IV the ESRD PPS and PFS payment options for transplantation, dialysis CKD as required by section systems only to the extent necessary to modalities, and vascular access, the 1861(ggg)(1)(A) of the Act and in the make these payment adjustments under uptake of this service has been low at implementing regulations at 42 CFR this proposed payment model for ETC less than 2 percent of eligible patients. 410.48(b)(1). We understand this Participants selected in accordance with CMS believes that the KDE benefit is prevents many beneficiaries in Stage V CMS’s proposed selection methodology. one of the best tools to promote of CKD from receiving the benefits of Also, we would waive the requirement treatment modalities other than in- KDE before starting dialysis or pursuing in section 1881(h)(1)(A) of the Act that center HD and that this waiver is a transplant. We hypothesize that payments otherwise made to a provider necessary to test ways to increase its beneficiaries with ESRD could also of services or a renal dialysis facility utilization from its current low rate as benefit from this education in the first under the system under section part of the model test. 6 months after an ESRD diagnosis. 1881(b)(14) of the Act for renal dialysis We propose to waive the following While CKD Stage V and early ESRD services be reduced by up to 2.0 percent requirements for ETC Participants patients’ disease may be more advanced if the provider of services or renal billing for KDE services: and the prospect of dialysis or • Currently, doctors, physician dialysis facility does not meet the transplant more certain than for patients assistants (PAs), nurse practitioners requirements of the ESRD QIP for a with Stage IV CKD, there is still (NPs), and clinical nurse specialists payment year, as may be necessary opportunity to improve beneficiary solely for purposes of ensuring that the (CNSs) are the only clinician types that knowledge to ensure the best patient- ESRD QIP payment reduction would be can furnish and bill for KDE services as centered care and outcomes. GAO applied to ESRD PPS payments that required by section 1861(ggg)(2)(A)(i) of recommended covering the KDE benefit have been adjusted by the HDPA and the Act and its implementing regulation for beneficiaries with Stage V CKD. 135 the PPA. In addition, we propose that at 42 CFR 410.48(c)(2)(i). However, the We propose to waive the requirement the payment adjustments made under payment for KDE is lower than a typical that KDE is covered only for Stage 4 this Model, would not change evaluation and management (E/M) visit, CKD patients for purposes of testing the beneficiary cost sharing from the regular so there may be limited financial ETC Model and to permit beneficiaries Medicare program cost sharing for the incentive for these clinician types to with CKD Stage V and those in the first related Part B services that were paid for conduct the KDE sessions. There are beneficiaries who receive services from various other types of health care 6 months of receiving an ESRD ETC Participants. We propose that providers that also may be well-suited diagnosis to receive the benefit, when beneficiary cost sharing be unaffected to educate beneficiaries about kidney billed by an ETC Participant who is a because if beneficiary cost sharing disease, such as registered dieticians Managing Clinician. • changed as a result of the HDPA and the and nephrology nurses. In its 2015 Under 42 CFR 410.48(d)(1), at least PPA, this would create a perverse report on home dialysis, GAO one of the KDE sessions must be incentive in which beneficiaries would recommended allowing other types of dedicated to management of pay less to receive services from ETC health care providers to perform KDE to comorbidities, including delaying the Participants with lower rates of home increase uptake of the benefit.134 We need for dialysis. Because we are dialysis and transplants, potentially propose to waive the requirement that proposing a waiver that would extend increasing beneficiary interest in KDE be performed by a physician, PA, the KDE benefit to beneficiaries with receiving care from providers and NP or CNS, to allow additional clinical CKD Stage V and ESRD in the first 6 suppliers performing poorly on the rates staff such as dietitians and social months of diagnosis, this KDE topic may the ETC Model intends to improve, workers to furnish the service under the no longer be relevant to patients who which would run counter to the intent direction of a Medicare-enrolled are facing a more immediate decision to of the Model. participating Managing Clinician. The commence dialysis or arrange for a Therefore we would waive the staff need not be Medicare-enrolled, but kidney transplant. We propose to waive requirements of sections 1833(a), would furnish these services incident to the requirement that KDE include the 1833(b), 1848(a)(1), 1881(b), and the services of a clinician authorized to topic of managing comorbidities and 1881(h)(1)(A) of the Act to the extent bill Medicare for KDE services as delaying the need for dialysis under the that these requirements otherwise specified in section 1861(ggg)(2)(B)(i). ETC Model, when furnishing KDE to would apply to payments made under We considered also waiving the beneficiaries with CKD Stage V and the ETC Model. We seek comment on requirement under section ESRD. We propose further clarifying, our proposed waivers of Medicare 1861(ggg)(2)(B) of the Act and the however, that ETC Participants who are payment requirements related to the implementing regulation at 42 CFR Managing Clinicians furnishing KDE HDPA and PPA and beneficiary cost 410.48(c)(2)(ii) restricting ESRD (either personally or with clinical staff sharing. facilities from billing for KDE directly, incident to their services) must still but decided not to, as we do not believe cover this topic if relevant to the b. Waiver of Select KDE Benefit beneficiary, for example, if the Requirements it is necessary for testing the Model. Moreover, ESRD facilities are already beneficiary has not yet started dialysis We believe it is necessary for required to educate beneficiaries about and can still benefit from education purposes of testing the ETC Model to their treatment modality options in the regarding delaying dialysis. waive select requirements of the KDE benefit authorized in section 134 United States Government Accountability 135 United States Government Accountability 1861(ggg)(1) of the Act and in the Office. 2015. Office. 2015.

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• Under 42 CFR 410.48(d)(5)(iii), an Participants must comply with all nor may ETC Participants provide outcomes assessment designed to applicable laws and regulations. services or benefits to individuals with measure beneficiary knowledge about disabilities through programs that are 9. Beneficiary Protections CKD and its treatment must be separate or different, excepting those performed by a qualified clinician As we discuss in section IV.C.4.b, we separate programs that are necessary to during one of the 6 sessions. This propose to attribute non-excluded ESRD ensure that the benefits and services are requirement presents two challenges; Beneficiaries and, as applicable, pre- equally effective. first that it may take away time from a emptive transplant beneficiaries to the In addition, as described previously session that could be dedicated ETC Participant that furnishes the in sections IV.C.4.c and IV.C.5.e.(2) of exclusively to education, and second plurality of the beneficiary’s dialysis this proposed rule, we are proposing to that if a beneficiary demonstrates and other ESRD-related services. apply the Clinician HDPA and the inadequate knowledge, there may not be Although the ETC Model would not Clinician PPA to the amount otherwise sufficient time in one session to address allow ESRD Beneficiaries to opt out of paid under Medicare Part B and all areas in which a beneficiary might the payment adjustment methodology furnished by the Managing Clinician need assistance. If the outcomes being applied to the Medicare payments during the CY subject to adjustment, assessment could be performed by made for their care, the Model would which would mean that beneficiary cost qualified staff during a follow-up visit to not affect beneficiaries’ freedom to sharing would not be affected by the the Managing Clinician, there would choose their dialysis services provider application of the Clinician HDPA and still be 6 full KDE sessions available to or supplier, meaning that beneficiaries the Clinician PPA. Similarly, as beneficiaries, and we believe there may elect to see any Medicare-enrolled described in section IV.C.7.a. of this would be more flexibility for the provider or supplier including those proposed rule, we intend to use our qualified staff to reinforce what the selected and not selected to participate waiver authority under section beneficiary learned during the KDE in the Model based on geography. In 1115A(d)(1) of the Act to issue certain sessions and fill in any gaps. We addition, the general beneficiary payment waivers, in accordance with, propose to maintain the requirement protections described in section which beneficiaries would be held that an outcomes assessment be II.B.2.a.(8) of this proposed rule would harmless from any model-specific performed by qualified staff in some apply to the ETC Model; accordingly, payment adjustments made to Medicare manner within one month of the final ETC Participants would be prohibited payments under this Model. from restricting beneficiary freedom of KDE session, but to waive the In proposed § 512.330(a), we would choice or access to medically necessary requirement that it be conducted within require ETC Participants to prominently covered services, which includes the a KDE session. display informational materials in each beneficiary’s choice regarding the of their offices or facility locations We also considered waiving the co- appropriate modality to receive covered where beneficiaries receive treatment to insurance requirement for the KDE services. ETC Participants also would be notify beneficiaries that the ETC benefit and certain telehealth prohibited from using or distributing Participant is participating in the ETC requirements to allow the KDE benefit descriptive model materials and Model. This notification would serve to to be delivered via telehealth for activities that are materially inaccurate inform a beneficiary that his or her beneficiaries outside of rural areas and or misleading. We propose to prohibit provider or supplier is participating in other applicable limitations on ETC Participants from offering or paying a model that incentivizes the use of telehealth originating sites, but did not any remuneration to influence a home dialysis and kidney transplants believe those waivers were necessary for beneficiary’s choice of renal and who to contact if they have purposes of testing the Model. replacement modality, unless such questions or concerns. We are proposing We seek comment on our proposals to remuneration complies with all this notification to further non- waive select requirements of the KDE applicable law. We believe this policy is speculative government interests benefit for purposes of testing the ETC necessary to help ensure that including transparency and beneficiary Model and alternatives considered. beneficiary modality selection is based freedom of choice. So as not to be 8. Compliance With Fraud and Abuse on the care of the beneficiary and the unduly burdensome, CMS intends to Laws beneficiary’s needs and preferences, provide a template for these materials to rather than financial or other incentives ETC Participants, which would identify The authority for the ETC Model is the beneficiary may have received or required content that the ETC section 1115A of the Act. Under section been offered. Participant must not change and places 1115A(d)(1) of the Act, the Secretary of Furthermore, beneficiaries with where the ETC Participant may insert its Health and Human Services may waive disabilities who receive care from ETC own original content. This template such requirements of Titles XI and XVIII Participants, including dementia and would include information for and of sections 1902(a)(1), 1902(a)(13), cognitive impairments, remain beneficiaries about how to contact the 1903(m)(2)(A)(iii), and certain protected under Federal disability rights ESRD Network Organizations with any provisions of section 1934 as may be laws including, but not limited to, questions or concerns regarding necessary solely for purposes of carrying section 504 of the Rehabilitation Act of participation in the ETC Model by their out section 1115A with respect to 1973, the Americans with Disabilities health care provider(s). (The 18 ESRD testing models described in section Act of 1990, as amended, and section Network Organizations serve distinct 1115A(b). For this Model and consistent 1557 of the Patient Protection and geographical regions and operate under with this standard, the Secretary may Affordable Care Act. These beneficiaries contract to CMS; their responsibilities consider issuing waivers of certain fraud cannot be denied access to home include oversight of the quality of care and abuse provisions in sections 1128A, dialysis or kidney transplant due to to ESRD patients, the collection of data 1128B, and 1877 of the SSA. However, their disability. ETC Participants may to administer the national Medicare no fraud and abuse waivers are being not apply eligibility criteria for ESRD program, and the provision of issued for this Model. Thus, participation in programs, activities, technical assistance to ESRD providers notwithstanding any other provision of and services that screen out or tend to and patients in areas related to ESRD). this proposed regulation, all ETC screen out individuals with disabilities; All other ETC Participant

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communications with beneficiaries that continue to receive high-quality, low adversely affecting the population of are descriptive model materials and cost, and medically appropriate care. beneficiaries included in the Model. activities would be subject to the We recognize that one of the likely We also would be examining the requirements for such materials and outcomes of this Model would be an extent of any unintended consequences, activities included in the general increase in utilization of home dialysis, including any increase in adverse provisions, as discussed in section II.D.3 however, in testing payment incentives clinical events such as graft failures, of this proposed rule. aimed at increasing utilization of this returns to dialysis, peritonitis and other We invite public comment on the modality there may be a risk of health incidents due to home dialysis, proposed beneficiary protections for the inappropriate steering of ESRD fluctuations in machine and supplies ETC Model. Beneficiaries who are unsuitable for markets, lemon-dropping clinically home dialysis. Therefore, to avoid 10. Monitoring complex patients, cherry-picking of less inappropriate use of home dialysis, as clinically complex patients, increase in a. Monitoring Activities described in section IV.C.5.c.(3) of this referrals to home dialysis for patients If finalized, the general provisions proposed rule, we propose to use risk that are not physically or cognitively relating to monitoring proposed in adjustment to account for factors related able to safely handle the responsibility to good candidacy for home dialysis. As section II.I of this rule would apply to of dialyzing at home, or an increase in described in section IV.C.5.b.(1) of this ETC Participants, including but not referrals to comparison geographic proposed rule, we also propose to limited to cooperating with the model areas. Specifically we would monitor exclude from beneficiary attribution monitoring activities per the proposed the rate at which back-up in-center certain categories of beneficiaries not § 512.150, granting the government the dialysis (Claim Code 76) and ESRD self- well suited to home dialysis, including right to audit per the proposed care retraining (Claim Code 87) are used beneficiaries with a diagnosis of § 512.135(a), and retaining and for home dialysis beneficiaries. The use dementia. We are proposing these providing access to records per of back-up dialysis for a home dialysis eligibility criteria to exclude certain § 512.135(c) and § 512.135(b), beneficiary can also be an indicator of categories of beneficiaries from respectively. CMS would conduct the equipment malfunction. Under the attribution up front so Managing Innovation Center’s authority in 42 CFR model monitoring activities in Clinicians and ESRD facilities that are accordance with the proposed 403.1110, and built upon in the ETC Participants do not attempt or proposed § 512.130, we would seek to § 512.150. We believe that we must believe that it is wise to attempt to place closely monitor the implementation and obtain clinical data for home dialysis these particular beneficiaries on home patients such as an increase in instances outcomes of the ETC Model throughout dialysis. In addition, CMS would its duration. The purpose of monitoring of fever, abnormal bleeding, access monitor for inappropriate point issues, and changes in vitals or would be to ensure that the Model is encouragement or recommendations for implemented safely and appropriately; weight, from ETC Participants for home dialysis through the proposed monitoring purposes and also would that ETC Participants comply with all monitoring activities. Instances of use applicable Medicare claims data. the terms and conditions of the ETC inappropriate home dialysis may show We welcome input about how to best Model; and to protect beneficiaries from up in increased patient hospitalization, track issues with home dialysis potential harms that may result from the infection, or incidence of peritonitis. equipment and machines and the format activities of an ETC Participant. All For example, multiple incidences of monitoring activities under the ETC peritonitis would be a good indicator of any proposed documentation for any Model would focus exclusively on that the patient should not be on PD. If incidents that occur, and how CMS Medicare FFS beneficiaries. claims data show unusual patterns, we should share any information about Consistent with proposed § 512.150, propose to review a sample of medical incidents that occur. we propose that monitoring activities records for indicators that a beneficiary For those beneficiaries attributed to may include documentation requests was not suited for home dialysis. ETC Participants who have received a sent to the ETC Participant; audits of Through patient surveys and interviews, kidney transplant, we would monitor claims data, quality measures, medical CMS would look for instances of transplant registry data from the SRTR, records, and other data from the ETC coercion on beneficiary choice of Medicare claims data available for life of Participant; interviews with members of modality against beneficiary wishes. If transplant, post-transplant rates of the staff and leadership of the ETC such instances of coercion were found, hospitalization and ED visits, infection Participant; interviews with we would take one or more remedial and rejection rates, and cost of care beneficiaries and their caregivers; site action(s) as described at proposed compared to the beneficiaries who have visits to the ETC Participant; monitoring § 512.160 against the ETC Participant received a kidney transplant and are not quality outcomes and clinical data; and and refer the case to CMS for further included in the ETC Model test. tracking patient complaints and appeals. investigation and/or remedial action. A key pillar of our monitoring strategy Specific to the ETC Model, we would Additionally, we would employ for both transplant, pre-emptive use the most recent claims data longer-term analytic strategies to transplant and home dialysis available to track utilization of certain confirm our ongoing analyses and detect beneficiaries would be stakeholder types of treatments, beneficiary more subtle or hard-to-determine engagement, and we would continue hospitalization and Emergency changes in care delivery and beneficiary conversations and relationships with Department use, and beneficiary referral outcomes. Some determinations of patient-advocate groups and closely patterns to make sure the utilization and beneficiary outcomes or changes in monitor patient surveys to uncover any beneficiary outcomes are in line with treatment delivery patterns may not be of the unintended consequences listed the Model’s intent. We believe this type able to be built into ongoing claims earlier or others that may be unforeseen. of monitoring is important because as analytic efforts and may require longer- We believe beneficiary and/or care ETC Participants adapt to new payment term study. We believe it is important partner feedback would be a incentives, we want to ensure to the to monitor the transplant and home tremendous asset to help CMS greatest extent possible that the Model dialysis trends over a longer period of determine and resolve any issues is effective and Medicare beneficiaries time to make sure the incentives are not directly affecting beneficiaries.

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In addition, we are seeking comment The SMR is NQF endorsed, indicating through ESRD facilities, and barring on how the proposed payment that it serves as a reliable and valid beneficiaries excluded from the adjustments under the ETC Model may measure of mortality among ESRD measures per the measure influence delivery-oriented beneficiaries who receive dialysis at specifications, the majority of ESRD interventions among participating ESRD ESRD facilities. Beneficiaries attributed to an ETC facilities and Managing Clinicians (for We considered including the In- Participant would be captured in these example, increased Managing Clinician Center Hemodialysis (ICH) CAHPS® measures. These measures also include knowledge of dialysis modalities, survey to monitor beneficiary ESRD Beneficiaries before they receive a greater patient education, increased perceptions of changes in quality of care kidney transplant; however, investment in equipment and supplies), as a result of the ETC Model. However, beneficiaries post-transplant would not as well as how the Model’s financial the ICH CAHPS survey includes only be included, per the measure incentives may affect the resourcing of beneficiaries who receive in-center specifications. these endeavors, and what are the dialysis. The survey specifically We invite public comment on the barriers to change. excludes the two beneficiary proposed quality measures and whether We invite public comment on our populations that the ETC Model would their proposed use would enable CMS proposed monitoring plan for the ETC focus on, namely beneficiaries who to sufficiently monitor for adverse Model. dialyze at home and beneficiaries who events for ESRD beneficiaries, in receive transplants and, therefore, we combination with the monitoring b. Quality Measures are not proposing to use this measure activities previously described. We also In addition to the monitoring for purposes of the ETC Model. invite other suggestions as to measures activities discussed previously, we We considered including quality that would support monitoring propose two ESRD facility quality measures for Managing Clinicians that beneficiary health and safety under the measures for the ETC Model: are reported by Managing Clinicians for model, while minimizing provider • Standardized Mortality Ratio MIPS or other CMS programs. However, burden. (SMR); NQF #0369—Risk-adjusted whereas all ESRD facilities are subject to We also invite public comment on the standardized mortality ratio of the the same set of quality measures under proposal not to tie quality measurement number of observed deaths to the the ESRD QIP, there is no analogous to the payment adjustments in the ETC number of expected deaths for patients source of quality measure data for Model. at the ESRD facility. Managing Clinicians. Managing Additionally, as described in section • Standardized Hospitalization Ratio Clinicians may be subject to MIPS, or IV.C.6 of this proposed rule, we propose (SHR); NQF #1463—Risk-adjusted they may be participating in a different that ETC Participants that are ESRD standardized hospitalization ratio of the CMS program—or an Advanced APM— facilities would still be included in the number of observed hospitalizations to which has different quality ESRD QIP and required to comply with the number of expected hospitalizations requirements. In addition, most that program’s requirements, including for patients at the ESRD facility. Managing Clinicians participating in being subject to a sliding scale payment SMR and SHR measures are currently MIPS select the quality measures on reduction if an ESRD facility’s total calculated and displayed on Dialysis which they report. Taken together, these performance score does not meet or Facility Compare, a public reporting factors mean that we would be unable exceed the minimum total performance tool maintained by CMS. The SHR is to ensure that all Managing Clinicians in score specified by CMS for the payment also included in the ESRD QIP measure the ETC Model are already reporting on year. ETC Participants who are set as a clinical measure on which ESRD a given quality measure, and therefore Managing Clinicians and are MIPS facilities’ performance is scored.136 would be unable to compare quality eligible clinicians would still be subject Because data collection and measure performance across all Managing to MIPS requirements and payment reporting are ongoing, there would be Clinicians without imposing additional adjustment factors, and those in a MIPS no additional burden to ETC burden. APM would be scored using the APM Participants to report data on these We propose that the SHR and SMR scoring standard. ETC Participants who measures for the ETC Model. Though measures would not be tied to payment are Managing Clinicians and who are in CMS has in a previous rule under the ETC Model. However, we an Advanced APM would still be acknowledged concerns that the SMR believe that the collection and assessed to determine whether they are might not be adequately risk adjusted monitoring of these measures would be Qualifying APM Participants (QPs) who, (78 FR 72208), we believe this measure important to guard against adverse as such, would earn the APM incentive is appropriate for purposes of the ETC events or decreases in quality of care payment and would not be subject to Model, under which the SMR would not that may occur as a result of the the MIPS reporting requirements or be used for purposes of determining performance-based payment payment adjustment. We do not propose payment. Mortality is a key health care adjustments in the ETC Model. We to waive any of these requirements for outcome used to assess quality of care believe we would be able to observe purposes of testing the ETC Model. in different settings. While we recognize changes over time in individual ESRD that the ESRD population is inherently facility level scores on these measures, 11. Evaluation at high risk for mortality, we believe as well as comparing change over time An evaluation of the ETC Model that mortality rates are susceptible to for ESRD facilities that are ETC would be conducted in accordance with the quality of care provided by dialysis Participants against change over time in section 1115A(b)(4) of the Act, which facilities, and note that the measure is those that are not ETC Participants. In requires the Secretary to evaluate each currently being used in the CEC Model. the aggregate, these measures should model tested by the Innovation Center. capture any increase in adverse events, We believe an independent evaluation 136 For the specifications for these measures, see particularly for patients on home of the Model is necessary to understand ‘‘CMS ESRD Measures Manual for the 2018 dialysis, as home dialysis patients are its impacts of the Model on quality of Performance Period/2020 Payment Year’’, June 20, 2018, https://www.cms.gov/Medicare/Quality- included in both the numerators and care and Medicare program Initiatives-Patient-Assessment-Instruments/ denominators of these measures. Home expenditures and to share with the ESRDQIP/Downloads/ESRD-Manual-v30.pdf. dialysis patients primarily receive care public. We would select an independent

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evaluation contractor to perform this the evaluation would take advantage of quality improvement techniques to evaluation. As specified in section II.E the mandatory nature of the ETC Model systematically spread the best practices of this rule, all ETC Participants will be for ESRD facilities and Managing of highest performers. The application required to cooperate with the Clinicians located in selected of broad scale learning and other evaluation. geographic areas. mechanisms for rapid and effective Research questions addressed in the While the model design would transfer of knowledge within a learning evaluation would include, but would control for the selection bias inherent in network would also be used. Quality not be limited to, whether or not the voluntary models, a comparison group improvement approaches would be ETC Model results in a higher rate of would still be necessary to determine if employed to improve performance by transplantation and home dialysis, any changes in outcomes are due to the collecting and analyzing data to identify better quality of care and quality of life, ETC Model or to secular trends in CKD the highest performers, and to help and reduced utilization and and ESRD care. The comparison group others to test, adapt and spread the best expenditures for beneficiaries in would be those Managing Clinicians practices of these high performers selected geographic areas in relation to and ESRD facilities located in throughout the entire national organ comparison geographic areas. The comparison geographic areas which recovery system. We believe that the evaluation would also explore would not be subject to the ETC Model implementation of the learning system qualitatively what changes Managing payment adjustments. The evaluator would help to increase the supply of Clinicians and ESRD facilities would match Managing Clinicians and transplantable kidneys, which would implemented in response to the ETC ESRD facilities located in comparison help ETC Participants achieve the goals Model, what challenges they faced, and geographic areas with Managing of the Model. lessons learned to inform future policy Clinicians and ESRD facilities that are developments. located in selected geographic areas 13. Remedial Action We propose that the ETC Model (that is, ETC Participants) using evaluation would employ a mixed- propensity scores or other accepted The remedial actions outlined in the methods approach using quantitative statistical techniques. Beneficiaries who general provisions in proposed and qualitative data to measure both the receive care from ESRD facilities and § 512.160, if finalized, would apply to impact of the Model and Managing Clinicians in these selected the ETC Model. Accordingly, if CMS implementation effectiveness. The geographic areas and comparison determines that an ETC Participant has impact analysis would examine the geographic areas would be identified engaged in one or more of the actions effect of the ETC Model on key using the ETC Model claims-based listed under proposed § 512.160(a) outcomes, including improved quality eligibility criteria, and would be (Grounds for Remedial Action), CMS of care and quality of life, and decreased attributed using the same claims-based may take one or more of the remedial Medicare expenditures and utilization. beneficiary attribution methods we actions listed under proposed The implementation component of the propose to use for purposes of § 512.160(b). evaluation would describe and assess calculating the MPS. how ETC Participants implement the The evaluation would account for any 14. Termination of the ETC Model Model, including barriers to and interaction with other CKD- and ESRD- If finalized, the general provisions facilitators of change. Findings from related initiatives at CMS, such as the relating to termination of the Model by both the impact analysis and the ESRD QIP, the CEC Model, and the KCF CMS proposed in section II.J of this implementation assessment would be Model, and the CKCC Models. For proposed rule would apply to the ETC synthesized to provide insight into what example, the evaluator would look for Model. Consistent with these worked and why, and to inform the disparate outcomes that could arise in provisions, in the event we terminate Secretary’s potential decision regarding the ESRD QIP between facilities that are the ETC Model, we would provide model expansion. also participating in the ETC Model and written notice to ETC Participants We would use multi-pronged data facilities that are not participating in the specifying the grounds for termination collection efforts to gather the ETC Model and also assess whether and the effective date of such quantitative and qualitative data needed performance in the ETC Model varies to understand the context of the Model termination or ending. As provided by for Managing Clinicians and ESRD section 1115A(d)(2) of the Act and implemented at participating ESRD Facilities who are also participating in facility and Managing Clinician proposed § 512.170, termination of the the CEC, KCF, or CKCC Models. Model under section 1115A(b)(3)(B) of locations and the perspectives of We invite public comment on our the Act would not be subject to different stakeholders. Data for the proposed approach related to the administrative or judicial review. analyses would come from sources evaluation of the proposed ETC Model. including, but not limited to, payment 12. Learning System V. Collection of Information and performance data files, Requirements administrative transplant registry data, In conjunction with the proposed ETC beneficiary focus groups, and interviews Model, CMS intends to operate a As stated in section 1115A(d)(3) of the with ETC Participants. voluntary learning system focused on Act, Chapter 35 of title 44, United States The quantitative impact analysis increasing the availability of deceased Code, shall not apply to the testing, would compare performance and donor kidneys for transplantation. The evaluation, and expansion of models outcome measures over time, using a learning system would work with, under section 1115A of the Act. As a difference-in-differences or a similar regularly convene, and support ETC result, the information collection approach to compare beneficiaries Participants and other stakeholders requirements contained in this proposed treated by ETC Participants to those required for successful kidney rule need not be reviewed by the Office treated by ESRD facilities and Managing transplantation, such as transplant of Management and Budget. However, Clinicians in comparison geographic centers, organ procurement we have summarized the anticipated areas. We would examine both organizations (OPOs), and large donor information collection requirements in cumulative and year-over-year impacts. hospitals. These ETC Participants and section VII.C.4 of the Regulatory Impact The quantitative analyses conducted for stakeholders would utilize learning and Analysis.

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VI. Response to Comments improved adherence to clinical including to cooperate with CMS’s Because of the large number of public guidelines and by collecting information monitoring and evaluation activities, for comments we normally receive on related to quality performance and the duration of the ETC Model. clinical practice. The RO Model would Federal Register documents, we are not 3. Impact of Proposed RO Model and incentivize RO participants to maintain able to acknowledge or respond to them ETC Model individually. We will consider all high quality care with the opportunity As detailed in Table 16A, we estimate comments we receive by the date and to earn back a withheld payment a net impact of $260 million to the time specified in the DATES section of amount through successful quality Medicare program due to the RO Model this proposed rule, and, when we outcomes and clinical data reporting. from January 1 2020 through December proceed with a subsequent document, As described in detail in section 31 2024, with a range of impacts we will respond to the comments in the III.C.8. of this proposed rule, RO between $50 million and $460 million preamble to that document. participants would be required to collect and submit data on quality in net Medicare savings. Alternatively, VII. Regulatory Impact Analysis measures, clinical data, and patient as detailed in Table 16B, we estimate a We have examined the impact of this experience throughout the course of the net impact of $250 million to the proposed rule as required by Executive RO Model, beginning January 1, 2020, Medicare program due to the RO Model Order 12866 and other laws and with the final data submission ending in from April 1 2020 through December 31 Executive Orders, requiring economic 2025. 2024, with a range of impacts between $40 million and $450 million in net analysis of the effects of proposed rules. 2. Need for Proposed End-Stage Renal A regulatory impact analysis (RIA) must Medicare savings. Disease (ESRD) Treatment Choices As detailed in Table 17, we estimate be prepared for major rules with (ETC) Model economically significant effects ($100 the Medicare program would save a net million or more in any 1 year). We Beneficiaries with ESRD are among total of $185 million from the PPA and estimate that this rulemaking is the most medically fragile and high-cost HDPA, which would be applied under ‘‘economically significant’’ as measured populations served by the Medicare the ETC Model between January 1, 2020 by the $100 million threshold and hence program. One of CMS’ goals in through June 30, 2026. We also expect also a major rule under the designing the ETC Model is to test ways that the ETC Model would cost an Congressional Review Act. Accordingly, to incentivize home dialysis and kidney additional $15 million, resulting from we have prepared a RIA that, to the best transplants, so as to enhance beneficiary increases in education and training choice of modality for renal replacement of our ability, reflects the economic costs. Therefore, the net impact to therapy, and improve quality of care impact of the policies contained in this Medicare spending is estimated to be and quality of life while reducing proposed rule. $169 million in savings as a result of the Medicare program expenditures. The ETC Model. A. Statement of Need substantially higher expenditures, We solicit comment on the mortality, and hospitalization rates for 1. Need for Proposed Radiation assumptions and analysis presented dialysis patients in the U.S. compared to Oncology (RO) Model throughout this regulatory impact those for individuals with ESRD in section. Radiotherapy (RT) services represent other countries indicate a population a promising area of health care for with poor clinical outcomes and B. Overall Impact payment and service delivery reform. potentially avoidable expenditures. We We have examined the impacts of this First, RT services can be furnished in anticipate improvement in quality of rule as required by Executive Order both freestanding radiation therapy care for beneficiaries and reduced 12866 on Regulatory Planning and centers paid under the Medicare expenditures under the ETC Model Review (September 30, 1993), Executive Physician Fee Schedule (PFS) and the inasmuch as the Model would create Order 13563 on Improving Regulation Outpatient Prospective Payment System incentives for beneficiaries, along with and Regulatory Review (January 18, (OPPS). There are site-of-service their families and caregivers, to choose 2011), the Regulatory Flexibility Act payment differentials between the OPPS the optimal kidney replacement (RFA) (September 19, 1980, Pub. L. 96– and PFS payment systems, which can modality. 354), section 1102(b) of the Social result in financial incentives to offer In section IV.B of this proposed rule, Security Act, section 202 of the care in one setting over another. Second, we describe how current Medicare Unfunded Mandates Reform Act of 1995 as in other health care settings, health payment rules and a deficit in (March 22, 1995; Pub. L. 104–4), care providers are financially beneficiary education result in a bias Executive Order 13132 on Federalism incentivized to provide more services to toward in-center hemodialysis, which is (August 4, 1999), the Congressional patients because they are paid based on often not preferred by patients or Review Act (5 U.S.C. 804(2)), and the volume of care they provide, not physicians relative to home dialysis or Executive Order 13771 on Reducing value. We believe that these incentives kidney transplantation. We provide Regulation and Controlling Regulatory are misaligned with evidence-based evidence from published literature to Costs (January 30, 2017). practice, which is moving toward support the projection that higher rates Executive Orders 12866 and 13563 furnishing fewer radiation treatments of home dialysis and kidney transplants direct agencies to assess all costs and for certain cancer types. Third, would reduce Medicare expenditures, benefits of available regulatory difficulties in coding and setting and, not only enhance beneficiary alternatives and, if regulation is payment rates for RT services have led choice, independence, and quality of necessary, to select regulatory to volatility in Medicare payment for life, but also preserve or enhance the approaches that maximize net benefits these services under the MPFS and quality of care for ESRD beneficiaries. (including potential economic, increased coding complexity and As described in detail in sections II. environmental, public health and safety administrative burden. As part of the and IV. of this proposed rule, ETC effects, distributive impacts, and RO Model’s design, CMS would also Participants would receive adjusted equity). Section 3(f) of Executive Order examine whether the model leads to payments and would be required to 12866 defines a ‘‘significant regulatory higher quality care by encouraging comply with certain requirements, action’’ as an action that is likely to

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result in a rule: (1) Having an annual The goal is to design a model that is ESRD Beneficiaries, through the ESRD effect on the economy of $100 million sufficiently large enough to achieve facilities and Managing Clinicians or more in any one year, or adversely adequate precision but not so large as to selected for participation in the Model. and materially affecting a sector of the waste CMS’s limited resources. These The Innovation Center would randomly economy, productivity, competition, decisions affect the quality of evidence select 50 percent of HRRs, stratified by jobs, the environment, public health or CMS is able to present regarding the region, and include separate from safety, or state, local or tribal impacts of a model on quality of care, randomization all HRRs for which at governments or communities (also utilization, and spending. least 20 percent of the component zip codes are located in Maryland. All referred to as ‘‘economically a. Radiation Oncology (RO) Model significant’’); (2) creating a serious ESRD facilities and Managing Clinicians inconsistency or otherwise interfering In the case of the RO Model, we in selected HRRs, referred to as selected with an action taken or planned by determined the sample size necessary geographic areas, would be required to another agency; (3) materially altering for a minimum estimated savings participate in the Model. There are the budgetary impacts of entitlement impact of three percent. While a savings currently 7,097 ESRD facilities and grants, user fees, or loan programs or the higher than three percent would require 7,283 Managing Clinicians enrolled in rights and obligations of recipients a smaller sample size from an Medicare, distributed across 306 HRRs thereof; or (4) raising novel legal or evaluation perspective, if we were to and providing care for 432,436 ESRD policy issues arising out of legal reduce the size of the RO Model and if Beneficiaries that meet the eligibility mandates, the President’s priorities, or the actual savings are at or just below criteria for attribution to ETC the principles set forth in the Executive the three percent level, then we would Participants under the Model. Only Order. As stated previously, this increase the risk of missing an approximately 10 percent of proposed rule triggers these criteria. opportunity to detect the actual savings beneficiaries on dialysis received home produced by the Model or of concluding dialysis in 2017. The ETC Model would C. Anticipated Effects there are savings when there are not apply the payment adjustments 1. Scale of the Model savings. described in section IV. of this proposed The RO Model as proposed would rule to claims with claim through dates There is no one-size-fits-all approach include 40 percent of radiation oncology between January 1, 2020 through June to designing, implementing, and episodes in eligible geographic areas, as 30, 2026, and over that time period, evaluating models. Each payment and defined in this proposed rule. In a would include an estimated 3,548 ESRD service delivery model tested by the simulation, we randomly selected facilities, 3,642 Managing Clinicians, Innovation Center is unique in its goals, CBSAs and found that there would be 216,218 beneficiaries, and $169 million and thus its design. Models vary in size 616 physician group practices (PGPs) in net Medicare savings. See Table 17 in order to accommodate various design (325 being freestanding radiation for an annual breakdown. features and satisfy a variety of therapy centers) and 541 hospital priorities. Decisions made regarding the outpatient departments furnishing RT c. Aggregate Effects on the Market features and design of the model services in those simulated selected There may be spillover effects in the strongly influence the extent to which CBSAs. Among the simulated selected non-Medicare market, or even in the the evaluation will be able to accurately PGPs, 173 furnish RT services in both Medicare market in other areas as a assess the effect of a given model test freestanding radiation therapy centers result of these models, if finalized. and produce clear and replicable and HOPDs. 285 PGPs furnish RT Testing changes in Medicare payment results. services only in HOPDs, and 158 PGPs policy may have implications for non- The Innovation Center conducts furnish RT services only in freestanding Medicare payers. As an example, non- analyses to determine the ideal number radiation therapy services. These Medicare patients may benefit if of participants for each model for providers and suppliers furnished 39.7 participating providers and suppliers evaluation purposes. This analysis percent of radiation oncology episodes introduce system-wide changes that considers a variety of factors including nationally, based on data from 2015 to improve the coordination and quality of the target population (for example, 2017. If finalized as proposed with the health care. Other payers may also be Medicare beneficiaries with select Model starting in January 2020, thee RO developing payment models and may medical conditions), model eligibility Model would have a 5-year performance align their payment structures with (for example, beneficiary eligibility period and include an estimated CMS or may be waiting to utilize results criteria for inclusion in the model), 364,000 episodes, 322,000 beneficiaries, from CMS’ evaluations of payment participant enrollment strategy (for and $5.4 billion in total episode models. Because it is unclear whether example, mandatory versus voluntary) spending of allowed charges (inclusive and how this evidence applies to a test and, the need to test effects on of beneficiary cost-sharing). See Table of these new payment models, our subgroups. Model size can also be 16A for an annual breakdown. If analyses assume that spillover effects on influenced by the type and size of finalized as proposed, with an April 1, non-Medicare payers will not occur, hypothesized effect on beneficiary 2020 start date, the RO Model would although this assumption is subject to outcomes, such as quality of care, or the have a 5-year performance period and considerable uncertainty. We welcome target level of model savings. The include an estimated 346,000 episodes, comments on this assumption and smaller the expected impact a model is 307,000 beneficiaries, and $5.1 billion evidence on how this rulemaking, if hypothesized to achieve, the larger a in total episode spending of allowed finalized, would impact non-Medicare model needs to be to have confidence in charges (inclusive of beneficiary cost- payers and patients. the observed impacts. sharing). See Table 16B for an annual An insufficient number of breakdown. 2. Effects on the Medicare Program participants increases the risk that the a. Radiation Oncology Model evaluation will be imprecise in b. End-Stage Renal Disease (ESRD) detecting the true effect of a model, Treatment Choices (ETC) Model (1) Overview potentially leading, for example, to a The ETC Model as proposed would Under the current FFS payment false negative or false positive result. include approximately 50 percent of system, RT services are paid on a per

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service basis to both PGPs (including expenditures. The simulation relied unique NPI) would receive the APM freestanding radiation therapy centers) upon statistical assumptions derived incentive payment under the Quality and HOPDs through the PFS and the from retrospectively constructed RT Payment Program at some point (at least OPPS, respectively. The proposed RO episodes between 2015 and 2017. This one QP Performance Period) during the Model would be a mandatory model information was reviewed and model performance period. This designed to test a prospectively determined to be reasonable for the assumption is based on applying the determined episode payment for RT estimates. 2019 QPP final rule qualification criteria services furnished to Medicare To project baseline expenditures, to simulated billing and treatment beneficiaries during episodes initiated traditional FFS payment system billing patterns for each QPP performance year between January 1, 2020 and December patterns are assumed to continue under during the RO model test. Episode- 31, 2024. current law. Forecasts of the Medicare initiating physicians were assumed to The proposed RO Model would test Part A and Part B deductibles were form an APM entity with the TIN(s) differences in payment from traditional obtained from the 2018 Medicare under which they bill for RT services. FFS Medicare by paying model Trustees Report and applied to For each APM entity, counts of total participants two equal lump-sum simulated episode payments. In treated patients and spending for payments, once at the start of the addition, current relative value units covered physician services under the episode and again at the end, for under the PFS and relative payment RO Model were estimated and applied episodes of care. Episodes would be weights under the OPPS are assumed to to QPP qualification criteria based on defined as all Medicare items and be fixed at the simulated levels found in CY2017 provider billing patterns. services described in proposed the 2015 through 2017 ARC episode As proposed, the APM incentive § 512.235 that are furnished to a data. payment would apply only to the Similarly, conversion factors in both beneficiary described in proposed professional episode payment amounts the PFS and OPPS were indexed to the § 512.215 during the period of time that and not the technical episode payment appropriate update factors under begins with episode initiation defined amounts. We also assume HOPD line current law. Payment rate updates to in proposed § 512.245 and ends 89 days item cap as described in section future PFS conversion factors are after the start date of the episode. Once 1833(t)(8)(C)(i) of the Act will continue legislated at 0.25 percent in 2019 and an episode is initiated, RO participants to be applied as is done under current 0.0 percent for 2020 through 2024 under would no longer be allowed to law. separately bill other HCPCS codes or the Medicare Access and CHIP APC codes for activities related to Reauthorization Act of 2015. OPPS Complete information regarding the radiation treatment for the RO conversion factors are assumed to be data sources and underlying beneficiary in that episode. updated at the Hospital Market Basket methodology for withhold For each participating entity, the less Multifactor Productivity in our reconciliation were not available at the participant-specific professional simulation. We forecast that net OPPS time of this forecast. In the case of the payment and participant-specific updates would outpace the PFS by 3.0 incomplete payment withhold, we technical episode payment amounts percent on average annually between assume CMS retains payment only in would be determined as described in 2019 and 2024. the event that offsetting payment errors detail in section III.C.6. of this proposed were made elsewhere. Past CMS (3) Medicare Estimate rule. experience in other value based The RO Model would not be a total Table 16 summarizes the estimated payment initiatives that included a cost of care model. RO participants impact of the proposed RO Model. We penalty for not reporting have shown would still bill traditional FFS Medicare estimate that on net the Medicare high rates of reporting compliance. for services not included in the episode program would save $260 million ($250 Given the limited spending being payment and, in some instances, for less million with an April 1 start date) over withheld, scoring criteria, and specified common cancers not included in the the 5 performance years (2020 through timeframes involved, we assume that model and other exclusion criteria. A 2024) with final data submission of quality and patient experience list of cancer types that meet the clinical data elements and quality withholds, on net, have a negligible proposed criteria for inclusion in the RO measures in 2025 to account for financial impact to CMS. In Table 16, Model and associated FFS procedure episodes ending in 2024. This is the net negative spending reflects a reduction in codes are included in section III.C.5. of Medicare Part B impact that includes Medicare spending, while positive this proposed rule. both Part B premium and Medicare spending reflects an increase. No APM Advantage United States Per Capita incentive payments would be paid (2) Data and Methods Costs (MA USPCC) rate financing based on participation in the RO Model A stochastic simulation was created to interaction effects. in 2020 and 2021, due to the two-year estimate the financial impacts of the We project that 82 percent of lag between the QP performance and proposed RO Model relative to baseline physician participants (measured by payment periods.

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A key assumption underlying the an ESRD facility for all of the renal § 512.340 and § 512.350 for ESRD above impact estimate is that the dialysis services defined in section facilities and § 512.345 and § 512.350 volume and intensity (V&I) of the 1881(b)(14)(B) of the Act and furnished for Managing Clinicians, during the bundled services per episode remains to individuals for the treatment of ESRD initial 3 years of the ETC Model. unchanged between the period used for in the ESRD facility or in a patient’s The PPA would be an upward or rate setting and when payments are home. Under the Physician Fee downward payment adjustment on made. If V&I were to decrease by 1.0 Schedule, medical management of an certain dialysis and dialysis-related percent annually for the bundled ESRD beneficiary receiving dialysis by a claims submitted by ETC participants, services absent the model, then we physician or other practitioner is paid as described in proposed § 512.375(a) estimate Medicare would only reduce through the MCP. The proposed ETC and § 512.380 for ESRD facilities and net outlays by $50 million ($40 million Model would be a mandatory payment § 512.375(b) and § 512.380 for Managing with an April 1 start date) between 2020 model designed to test payment Clinicians, that would apply to claims and 2024. Similarly if V&I increases by adjustments to certain dialysis and with claim through dates beginning on 1.0 percent annually then net outlays dialysis-related payments, as discussed July 1, 2021 and increase in magnitude would be reduced by $460 million ($450 in section IV. of this proposed rule, for over the duration of the Model. CMS million with an April 1 start date) for ESRD facilities and to the MCP for would assess each ETC Participant’s the projection period. Please note that Managing Clinicians from January 1, home dialysis rate, as described in although V&I growth from 2014 through 2020 to June 30, 2026. proposed § 512.365(b), and transplant 2017 fell within this 1.0 percent range Under the proposed ETC Model, there rate, as described in proposed and did not exhibit a secular trend, would be two payment adjustments § 512.365(c), for each Measurement actual experience may differ. designed to increase rates of home Year. The ETC Participant’s home b. ESRD Treatment Choices Model dialysis and kidney and kidney- dialysis rate and transplant rate would pancreas transplants through financial be risk adjusted and reliability adjusted, (1) Overview incentives. The HDPA would be an as described in proposed § 512.365(d) Under the ESRD Prospective Payment upward payment adjustment on certain and proposed § 512.365(e), respectively. System (PPS) under Medicare Part B, a home dialysis and home dialysis-related The ETC Participant would receive a single per-treatment payment is made to claims, as described in proposed Modality Performance Score (MPS)

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based on the weighted sum of the higher facility and Managing Clinician, attributed to individual ETC of the ETC Participant’s achievement respectively. Participants and to improve score or improvement score for the The ESRD facilities data were comparisons between ETC Participants home dialysis rate and the higher of the aggregated to the CMS Certification and those ESRD facilities and Managing ETC Participant’s achievement score or Number (CCN) level for beneficiaries on Clinicians not selected for participation improvement score for the transplant dialysis identified by outpatient claims in the Model for purposes of rate, as described in proposed with Type of Bill 072X to capture all achievement benchmarking and scoring, § 512.370(d). In MY 1 and MY 2, the dialysis services furnished at or through described in section IV.C.5.d of this achievement scores would be calculated ESRD facilities. Beneficiaries receiving proposed rule. Four credibility tiers of in relation to a set of benchmarks based home dialysis services were defined as total member months (that is, 400, 600, on the historical rates of home dialysis condition codes 74, 75, 76, and 80. 800, and 1,000) were constructed with and kidney transplants among ESRD Beneficiaries receiving in-center dialysis corresponding HRR weights of 80, 60, facilities and Managing Clinicians services were defined using condition 40, and 20 percent. ETC Participant located in comparison geographic areas. codes 71, 72, and 73. For consistency behavior for each year was simulated by We intend to increase these benchmarks with the proposed exclusion in adjusting the ETC Participant’s baseline over time through subsequent notice proposed § 512.385(a), ESRD facilities home dialysis (or transplant) rate for a and comment rulemaking, as discussed with less than 132 total attributed simulated statistical fluctuation and in section IV.C.5.d. of this proposed beneficiary months during a given MY then summing with the assumed rule. The improvement score would be were excluded. increase in home dialysis (or transplant) calculated in relation to a set of The Managing Clinicians’ data were rate multiplied by a randomly generated benchmarks based on the ETC aggregated to the group TIN, individual improvement scalar. The achievement Participant’s own historical TIN, or NPI (in order of availability) and improvement scores were assigned performance. The ETC Participant’s level for beneficiaries on home dialysis by comparing the participant’s MPS for a MY would determine the and were constructed using outpatient simulated home dialysis (or transplant) magnitude of its PPA during the claims with CPT® codes 90965 and rate for the MY to the percentile corresponding 6-month PPA Period, 90966. Beneficiaries receiving in-center distribution of home dialysis (or which would begin 6 months after the dialysis were defined by outpatient transplant) rates in the prior year. Last, end of the MY. An ETC Participant’s claims with CPT® codes 90957, 90958, the MPS was calculated using the MPS would be updated on a rolling 90959, 90960, 90961, and 90962. A low- maximum of each achievement or basis every 6 months. volume exclusion was applied to improvement score. The home dialysis The ETC Model would not be a total Managing Clinicians in the bottom 5 score constituted two-thirds of the MPS, cost of care model. ETC participants percent in terms of beneficiary-years for and the transplant score one-third of the would still bill FFS Medicare, and items which the Managing Clinician billed the MPS. and services not subject to the ETC MCP during the year. The HDPA calculation required a Model’s payment adjustments would The transplant data for ESRD facilities simplified methodology, with home continue to be paid as they would be in and Managing Clinicians were obtained dialysis and home dialysis-related the absence of the model. from Medicare inpatient claims with payments adjusted by 3, 2, and 1 percent during the first 3 years of the (2) Data and Methods MS–DRGs 008 and 652; and claims with ICD–10 procedure codes 0TY00Z0, model. A stochastic simulation was created to 0TY00Z1, 0TY00Z2, 0TY10Z0, The Kidney Disease Education (KDE) estimate the financial impacts of the 0TY10Z1, and 0TY10Z2.137 The benefit utilization and cost data were model relative to baseline expenditures. beneficiary attribution eligibility criteria identified by codes G0420 and G0421, to The simulation relied upon statistical in proposed § 512.360(b) and low- capture face-to-face individual and assumptions derived from volume exclusions in proposed group training sessions for chronic retrospectively constructed ESRD § 512.385 were applied to the transplant kidney disease beneficiaries on facilities’ and Managing Clinicians’ data in the ESRD facilities and treatment modalities. The home dialysis Medicare dialysis and transplant claims Managing Clinicians datasets. In training costs for incident beneficiaries reported during 2016 and 2017, the addition, the transplant data were on home dialysis for Continuous most recent years with complete data further restricted by excluding Ambulatory Peritoneal Dialysis (CAPD) available. Both datasets and the beneficiaries during any months in or Continuous Cycler-Assisted proposed risk-adjustment which they were 75 years of age or older Peritoneal Dialysis (CCPD) were defined ® methodologies for the ETC Model were or for any months in which they were using CPT codes 90989 and 90993 for developed by the CMS Office of the in a skilled nursing facility. complete and incomplete training Actuary. The home dialysis score and sessions, respectively. The ESRD facilities and Managing transplant score for the PPA were Data from calendar year 2017 were Clinicians datasets were restricted to the calculated using the following used to project baseline expenditures following eligibility criteria. methodology for the ESRD facilities and and the traditional FFS payment system Beneficiaries must be residing in the Managing Clinicians. A reliability billing patterns were assumed to United States, 18 years of age or older, adjustment was applied to the home continue under current law. and enrolled in Medicare Part B. dialysis (transplant) rate to account for (3) Medicare Estimate—Assume Rolling Beneficiaries enrolled in Medicare the small numbers of beneficiaries Advantage or other cost or Medicare Benchmark managed care plans, who have elected 137 SRTR data was not used in this analysis, as Table 17 summarizes the estimated hospice, receiving dialysis for acute it was not available at the time the analysis was impact of the ETC Model when kidney injury (AKI) only, or with a conducted. While this omission adds some small assuming a rolling benchmark where the diagnosis of dementia were excluded. In amount of uncertainty to the analysis, we do not achievement benchmarks for each year believe that this lack of data compromises the addition, the HRR was matched to the validity of the analysis, as the number of kidney are set using the average of the home claim service facility zip code or the and kidney-pancreas transplants not identifiable dialysis rates for year t-1 and year t-2 for rendering physician zip code for ESRD through claims data is very small. the HRRs randomly selected for

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participation in the ETC Model. We beneficiary level. We analyzed the base maintenance dialysis starts dialysis at estimate the Medicare program would variation in those facility/practice level home compared to the likelihood that a save a net total of 185 million dollars measures and simulated the effect of the current dialysis patient who dialyzes in from the PPA and HDPA between proposed payment policy assuming center switches to dialysis at home. The January 1, 2020 and June 30, 2026, less providers respond by marginally 3 percentage point per year max growth 15 million in increased training and increasing their share of patients rate would in effect move the average education expenditures. Therefore, the utilizing home dialysis. Random market peritoneal dialysis rate (about 10 net impact to Medicare spending is variables were used to vary the percent) to the highest market baseline estimated to be 169 million dollars in effectiveness that individual providers peritoneal dialysis rate (for example. savings. In Table 17, negative spending might show in such progression over Bend, Oregon HRR at about 25 percent), reflects a reduction in Medicare time and to simulate the level of year- which we believe is a reasonable upper spending, while positive spending to-year variation already noted in the bound on growth over the duration of reflects an increase. The results were base multi-year data that was analyzed. the ETC Model for the purposes of this generated from an average of 500 The uncertainty in the projection was actuarial model. simulations under the assumption that illustrated through an alternate scenario benchmarks are rolled forward with a assuming that the benchmarks against Individual ESRD facilities or 1.5 year lag. The projections do not which participants are measured were Managing Clinicians were assumed to include the Part B premium revenue to not be updated as well as a achieve anywhere from zero to 100 offset because CMS is proposing that the discussion of the 10th and 90th percent of such maximum growth in any payment adjustments under the ETC percentiles of the actuarial model given year. Thus, the average projected Model would not affect beneficiary cost- output. These sensitivity analyses are growth for the share of maintenance sharing. Any potential effects on described in sections VII.C.2.b.(3)(a) and dialysis provided in the home was 1.5 Medicare Advantage capitation VII.C.2.b.(3)(b), respectively. KDE on percentage points per year. Projected payments were also excluded from the treatment modalities and home dialysis forward, this would result in home projections. This approach is consistent (HD) training for incident dialysis dialysis ultimately representing with how CMS has previously conveyed beneficiaries are relatively small outlays approximately 19 percent of overall the primary Fee-For-Service effects and were projected to represent only maintenance dialysis in selected anticipated for an uncertain model relatively modest increases in Medicare geographic areas by 2026. In contrast, without also assessing the potential spending each year. we do not include an official impact on Medicare Advantage rates. The key assumptions underlying the assumption that the overall number of As anticipated, the expected Medicare impact estimate are that each ESRD kidney transplants will increase and program savings were driven by the net facility or Managing Clinician’s share of provide justification for this assumption effect of the ESRD facility PPA; a total maintenance dialysis provided in in the section VII.C.2.b.(4). of the reduction in Medicare spending of 220 the home setting was assumed to grow proposed rule. However, as part of the million dollars over the period from by up to an assumed maximum growth sensitivity analysis for the savings January 1, 2020 through June 30, 2026. averaging 3 percentage points per year. calculations for the model, we lay out In comparison, the net effect of the Factors underlying this assumption different savings scenarios if the Managing Clinician PPA was only 8 about the home dialysis growth rate incentives ETC Model were to cause an million dollars in Medicare savings. include; known limitations that may increase in living donation and if the This estimate was based on an empirical prevent patients from being able to learning system described in section study of historical home dialysis dialyze at home, such as certain IV.C.12 of this proposed rule were to be utilization and transplant rates for FFS common disease types that make successful in decreasing the discard rate beneficiaries that CMS virtually peritoneal dialysis impractical (for of deceased donor kidneys and assigned to dialysis facilities and to example, obesity); current equipment increasing the utilization rate of nephrology practices based on the and staffing constraints; and the deceased donor kidneys that have been plurality of associated spending at the likelihood that a patient new to retrieved.

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(a) Sensitivity Analysis: Medicare 0, 35, 89, and 62 million dollars, represent the most optimistic and Estimate—Assume Fixed Benchmark respectively. The fixed benchmark conservative projections, respectively. An alternative model specification would allow the ESRD facilities and The overall net PPA and HDPA for the was analyzed where benchmarks remain Managing Clinicians to have more top 10th and 90th percentiles using the fixed at baseline year 0 over time favorable achievement and rolling benchmark method are 264 and (results available upon request). Both improvement scores over time 112 million dollars in savings the fixed and rolling benchmark compared to the rolling benchmark (compared to 185 million dollars in assumptions projected about 19 million method. In summary, the total of overall savings in Table 17). dollars in increased overall HDPA net PPA and HDPA from January 1, (4) Effects on Kidney Transplantation 2020 through June 30, 2026, with the Medicare payments to ESRD facilities Kidney transplantation is considered and Managing Clinicians in 2020. We fixed benchmark, was 189 million dollars in losses, compared to a total of the optimal treatment for most ESRD project about 1 million dollars in beneficiaries. However, while the additional HD training add-on 185 million dollars in savings with the rolling benchmark method. The net proposed PPA includes a one-third payments. This would represent about weight on the ESRD facilities’ or 20 million dollars in increased Medicare impact on Medicare spending for the PPA and HDPA using the fixed Managing Clinician’s kidney transplant expenditures in 2020 overall. Both rate, we decided to be conservative and specifications of the benchmark also benchmark method is 203 million dollars in losses. did not include an assumption that the projected the net impact of overall number of kidney transplants approximately 1 million dollars in (b) Sensitivity Analysis: Medicare will increase. The number of ESRD increased Medicare expenditures in Savings Estimate—Results for the 10th patients on the kidney transplant wait 2021. and 90th Percentiles list has for many years far exceeded the The two scenarios diverge after 2021, annual number of transplants with large differences observed in Returning to the methodology used performed. Transplantation rates have overall net PPA and HDPA savings/ for the Medicare estimate with a rolling not increased to meet such demand losses. Table 17 illustrates that when benchmark, we compare the results because of the limited supply of benchmarks are rolled forward, using (available upon request) for the top 10th donated kidneys. The United States the methodology described in section and 90th percentiles of the 500 Renal Data System 138 reported 20,161 VII.C.2.b.(3), the overall savings in PPA individual simulations to the average of kidney transplants in 2016 compared to net and HDPA increase each year during all simulation results reported in Table an ESRD transplant waiting list of over the 2022–2026 period. In contrast, when 17. Since the impact on Medicare 80,000. Living donor kidney benchmark targets are fixed, in 2022 the spending for the proposed ETC Model overall PPA net and HDPA savings using the rolling benchmark method is 138 United States Renal Data System. 2018. ‘‘ADR increase to 16 million dollars, followed estimated to be in savings rather than Reference Table E6 Renal Transplants by Donor by overall losses in years 2022–2026 of losses, the top 10th and 90th percentiles Type.’’

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transplantation (LDKT) has actually Recovery and Improvement Act.141 All therefore, the projected spending need declined in frequency over the last applicants under this Act are means not be adjusted. For the next 25 percent decade while deceased donor kidney tested, with preference given to of LDKTs, we assumed the beneficiary transplantation (DDKT) now represent recipients and donors who are both is on dialysis and Medicare is the nearly three out of four transplants as of below 300 percent of the federal poverty primary payer, but they would 2016. line (FPL). Approved applicants can eventually leave Medicare enrollment if The PPA’s transplant incentive would receive up to $6,000 to cover travel, they had a transplant. We adjusted the expected Medicare spending for these likely increase the share of ESRD lodging, meals, and incidental expenses. In 2017, only 8.38 percent of the cases downward by 33 percent. This Beneficiaries who join the transplant approximate 6,000 total living kidney projected a savings of approximately wait list but is unlikely to impact the donations 142 received NLDAC support, $119,000 over 10 years relative to the donation supply limitation. There is resulting in up to $3 million in paid baseline spending projection of evidence that the overall quantity of expenses per year. Additional methods $292,117 over 10 years for beneficiaries transplants could be positively are necessary to decrease financial on dialysis. The third scenario— impacted by reducing the discard rate disincentives for kidney donors and covering the remaining 50 percent of for certain DDKT with lower quality, their recipients who exceed the means LDKTs—assumes Medicare is not the high-Kidney Donor Profile Index (KDPI) testing criteria of the NLDAC. primary payer when the transplant organs. However, while such The costs/savings incurred by kidney occurs. In this case, we assumed that transplantation has been shown to transplantation vary by donor type. Medicare spending is nominal relative improve the quality of outcomes for Axelrod et al. (2018) used Medicare to baseline spending and we adjust patients, kidney transplant centers have claims data with Medicare as the downward by 33 percent (that is, the reported barriers to their use including primary payer linked to national registry beneficiary would take up to 30 months a higher cost of providing care in such and hospital cost-accounting data to become a Medicare primary payer relatively complex transplant cases provides evidence for the cost-savings of enrollee absent the transplant), which relative to Medicare’s standard kidney transplantations by donor type projected a savings of approximately payment. Because the PPA would not compared to dialysis.143 The authors $195,000 over 10 years. The projected impact payment to transplant centers estimated ESRD expenditures to be weighted average program savings for the ETC Model would not mitigate the $292,117 over 10 years per beneficiary LDKT is $136,000 over 10 years per barrier to increased marginal kidney on dialysis. LDKT was cost-saving at 10 beneficiary. transplantations. Furthermore, even to years, reducing expected expenditures Therefore, a 20 percent increase in the the extent that marginal DDKT were for ESRD treatment by 13 percent rate of LDKT in model markets in a somehow improved because of PPA ($259,119) compared to maintenance single year, representing about 500 new incentives, evidence also suggests that dialysis. In contrast, DDKT with low- transplants mainly from relatives of the impact of DDKT with high-KDPI KDPI organs was cost-equivalent at recipients, would produce organs may not reduce overall spending $297,286 over 10 years compared to approximately $68 million in program despite improving the quality of dialysis. Last, DDKT with high-KDPI savings over 10 years (and multiples outcomes for patients. organs resulted in increased spending of thereof for each successive year the It is possible that the ETC Model $330,576 over 10 years compared to living donor transplant rate were thusly could generate additional live kidney dialysis. elevated). donations for which significant The approximately $33,000 in savings The model also includes an Medicare program savings could be per beneficiary over 10 years for LDKT investment in learning and diffusion for realized. For example, additional compared to maintenance dialysis is improving the utilization of deceased patient education could lead more likely a lower bound since living donor kidneys that are currently beneficiaries to find donors by tapping donation would help reduce the number discarded at a rate of approximately 19 into resources already available to of beneficiaries under the age of 65 who percent nationally.144 Similar to the remove financial disincentives to would be eligible for Medicare estimate above on the average impact to donors (for example, payment for travel, enrollment. The lower bound Medicare spending for LDKT, we housing, loss of wages, and post- conditional savings can be adjusted to estimated an average marginal savings operative care).139 140 The ETC Model as account for additional savings through to Medicare for DDKT by adjusting costs proposed does not include a proposal to reduced Medicare enrollment by reported by Axelrod et al. (2018) for assist with minimizing disincentives to considering the share of potential new DDKT with high-KDPI to account for living donors for their kidney donation; live donations across three main effects on Medicare payer status. We however, qualified donors may apply scenarios. include three scenarios based on type of for financial assistance through the The LDKT expected cost of $259,119 payer. National Living Donor Assistance over 10 years per beneficiary projected First, we assumed 50 percent of newly Center (NLDAC), which administers by Axelrod et al. (2018) assumes harvested deceased-donor kidneys federal funding received from HRSA Medicare primary payer status. For would be for beneficiaries enrolled in under the federal Organ Donation roughly 25 percent of LDKTs, Medicare Medicare, regardless of ESRD status. can be assumed to be the primary payer This scenario aligns with the Medicare regardless of transplant success; primary payer estimates from the study, 139 Salomon DR, Langnas AN, Reed AI, et al. 2015. ‘‘AST/ASTS Workshop on Increasing Organ approximately $38,000 higher spending Donation in the United States: Creating an ‘Arc of 141 Public Law 108–216 (section 377 of the Public for DDKT with high-KDPI over 10 years Change’ From Removing Disincentives to Testing Health Service (PHS) Act, 42 U.S.C. 274f). relative to maintenance dialysis. Incentives.’’ American Journal of Transplantation 142 OPTN & SRTR 2017 Annual Report. Section KI Second, we assumed 30 percent of 15: 1173–1179. Kidney Transplants. https://www.srtr.org/reports- 140 Tong A, Chapman JR, Wong G, Craig JC. 2014. tools/srtroptn-annual-data-report/. marginal DDKT would be for ‘‘Perspectives of Transplant Physicians and 143 Axelrod DA, Schnitzler MA, Xiao H, et al. Surgeons on Reimbursement, Compensation, and 2018. ‘‘An Economic Assessment of Contemporary 144 OPTN & SRTR 2017 Annual Report. Section KI Incentives for Living Kidney Donors.’’ American Kidney Transplant Practice.’’ American Journal of Kidney Transplants. https://www.srtr.org/reports- Journal of Kidney Disorders 64(4): 622–632. Transplantation 18: 1168–1176. tools/srtroptn-annual-data-report/.

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beneficiaries with Medicare as their benefit requirements that should make 3. Effects on Medicare Beneficiaries primary coverage where the transplant these educational sessions on treatment a. Radiation Oncology Model spending was adjusted downward by 33 modality options more accessible to percent to account for reduced liability beneficiaries targeted by the model and We anticipate that the RO Model for patients returning to non-Medicare address some of the barriers previously would benefit or have a negligible impact on the cost to beneficiaries status. Third, we assumed 20 percent of described. We assume the KDE benefit receiving RT services. Under current DDKT with high-KDPI would involve utilization growth rate to increase from beneficiaries not yet under Medicare as policy, Medicare FFS beneficiaries are 2.2 in 2020 to 3.2 in 2026. To arrive at generally required to pay 20 percent of their primary payer. For this scenario, this assumption, we began with the we adjusted the baseline dialysis the allowed charge for services current low utilization of the benefit. spending downward by 33 percent to furnished by HOPDs and physicians (for The utilization rate of the KDE benefit account for initial non-Medicare status example, those services paid for under during the waiting period and for the during the first year of the Model (2020) the OPPS and MPFS, respectively). This transplant spending we assumed 25 was set to 2 percent, which is consistent policy would remain the same under the percent of baseline Medicare spending with the current rate of utilization of the RO Model. More specifically, would still be present due to early graft benefit. We set the utilization growth beneficiaries would be responsible for failure before the end of the 10-year rate to increase by 0.2 percentage points 20 percent of each of the PC and TC window (recognizing the shorter each year during 2021 to 2026. episode payments made under the RO lifespan high-KDPI organs tend to offer Although the ETC Model will allow Model. Since we are proposing to take recipients). different types of health care providers a percentage ‘‘discount’’ off of the total Combining these assumptions to furnish the KDE benefit to payment to participants for both PC and produced an average 10 year savings to beneficiaries, there is no direct evidence TC episode payment amounts (this Medicare of approximately $32,000 per that this will cause an increase in the discount representing savings to beneficiary for DDKT with high-KDPI. utilization growth rate that differs Medicare), the total allowed charge for Overall, we found an increase in significantly from the historical rate. services furnished by HOPDs and physicians would decrease. Thus, marginal kidney utilization such that Challenges to increasing the utilization beneficiary cost-sharing, on average, the national discard rate would drop to growth rate include: The beneficiary’s would be reduced relative to what 15 percent by the end of the model Managing Clinician may not inform the typically would be paid under testing period, representing beneficiary of the option to seek KDE approximately 2,360 additional traditional Medicare FFS for an episode benefit sessions for a variety of reasons transplants and an estimated $76 of care. In addition, the limit on million in federal savings. (for example.—the Managing Clinician beneficiary cost-sharing in the HOPD For both living and deceased donor is unaware of the KDE benefit, setting to the inpatient deductible transplants, the illustrated potential alternative treatment modalities are not would continue under the RO Model. effect of the model would reduce long feasible for the beneficiary, or the In addition, we note that, because run program spending by $143 million. clinician believes that the beneficiary episode payment amounts under the RO Costs for this effort include a learning would not be able to make an informed Model would include payments for RT and diffusion investment of $25 million choice about dialysis modality after services that would likely be provided over the model testing period and a receiving the KDE benefit); if informed over multiple visits, individual potential increase in PPA adjustments to of the KDE benefit option, the beneficiary coinsurance payments clinician and facility payments of beneficiary may prefer to rely on their would likewise be higher than they approximately $30 million. The Managing Clinician’s recommendation would otherwise be for an individual projected increase in transplantation is rather than receive education about RT service visit. We would encourage estimated to produce a net savings of their treatment options; and the RO participants to collect coinsurance $88 million—a net return on investment beneficiary may not want to have an for services furnished under the RO of approximately 1.6. additional one to six sessions with a Model in multiple installments. (5) Effects on the KDE Benefit and HD health care provider for the provision of b. ESRD Treatment Choices Model Training Add-Ons the KDE benefit, as beneficiaries with We anticipate that the ETC Model The KDE benefit has historically late stage CKD and ESRD are medically would have a negligible impact on the experienced very low uptake, with less fragile and already in frequent contact cost to beneficiaries receiving dialysis. than 2 percent of eligible Medicare with the health care system. This results Under current policy, Medicare FFS beneficiaries utilizing this option. A in a projected doubling of the costs beneficiaries are generally responsible recent report summarized barriers to attributed to the KDE benefit to for 20 percent of the allowed charge for adequate education on home dialysis.145 approximately one million dollars in services furnished by providers and Kidney disease education may: Not be 2026. suppliers. This policy would remain the provided at all, be done only once, not The impacts of increased utilization same under the ETC Model. However, be appropriate for patient’s literacy level of the home dialysis (HD) training add- the Model would apply the Clinician or not provided in patient’s native on payment adjustment under the ESRD PPA and the Clinician HDPA to the language, not be done until after patient PPS are expected to be larger than the amount otherwise paid by Part B to starts in-center hemodialysis, and/or not KDE benefit costs as these trainings will ensure beneficiaries are held harmless be provided to caregivers. from any effect on cost sharing. The proposed ETC Model would be required for all incident beneficiaries on home dialysis. Assuming a stable 3 Additionally, Medicare FFS incorporate waivers of select KDE beneficiaries are generally responsible percent growth rate in home dialysis per for 20 percent of the allowed charge for 145 year, the 7 year total in HD training Chan CT, Wallace E, Golper TA, et al. 2018. Part B ESRD PPS services furnished by ‘‘Exploring Barriers and Potential Solutions in costs is projected to be 10 million an ESRD facility. This policy would Home Dialysis: An NKF–KDOQI Conference dollars. Outcomes Report.’’ American Journal of Kidney remain the same under the ETC Model. Disease 73(3): 363–371. However, CMS proposes to waive

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certain requirements of title XVIII of the in total (1,157 expected participants × We believe the burden estimate for Act as necessary to test the Facility PPA $144.34/participant = $167,000 total). quality measure and clinical data and Facility HDPA proposed under the The ETC Model would not alter the element reporting requirements that is Model and proposes that beneficiaries way ETC Participants bill Medicare. provided for Small Businesses in would be held harmless from any effect Therefore, we believe that there would Section VII.C.5.a would also apply to of these payment adjustments on cost be no additional burden for ETC RO Model participants that are not sharing. Participants related to billing practices. considered small entities. The burden In addition, the Medicare We believe the burden for audits and estimate for collecting and reporting beneficiary’s quality of life has the record retention do not diverge from quality measures and clinical data for potential to improve if the beneficiary existing provider requirements in the the RO Model may be equal to or less elects to have home dialysis as opposed Health Insurance Portability and than that for small businesses, which we to in-center dialysis. Studies have found Accountability Act (HIPAA) of 1996 estimate to be approximately $388.00 that home dialysis patients experienced (HIPAA) administrative simplification per entity per year. Since we estimate improved quality of life as a result of rules (45 CFR 164.316(b)(2)), which approximately 1,157 RO Model their ability to continue regular work require a covered entity, such as a participants, then total burden estimate 146 schedules or life plans; as well as physician billing Medicare, to retain for collecting and reporting quality better overall, physical, and required documentation for six years measures and clinical data would be 147 148 psychological health in from the date of its creation or the date approximately $449,000. Additionally, comparison to other dialysis options. when it last was in effect, whichever is the ETC Model does not require any 4. Effects on RO and ETC Participants later. While the HIPAA Privacy Rule additional quality measure or clinical does not include medical record data element reporting by ETC RO participants will be given retention requirements, it does require Participants. Therefore, we believe that instructions on how to bill for patients, there is no additional burden for ETC using RO Model-specific HCPCS codes. that covered entities apply appropriate administrative, technical, and physical Participants related to quality measures We expect it would take medical coding or clinical data reporting. staff approximately 0.72 hours [(((∼36 safeguards to protect the privacy of medical records and other protected Finally, we believe the burden pages * 300 words/per page)/250 words estimate for reading and interpreting per minute)/60 minutes) = 0.72] 149 to health information (PHI) for whatever period such information is maintained this proposed rule that is provided for read and learn the payment Small Businesses would also apply to by a covered entity, including through methodology and billing sections of the RO Model participants and ETC disposal. The Privacy Rule is available rule. In addition, we would add one participants that are not considered at 45 CFR 164.530(c). In addition, CMS hour to review the relevant MLN small entities. The burden estimate for requires records of providers submitting Matters publication, 1 hour to read the reading and interpreting this proposed cost reports to be retained in their RO Model billing guide, and one hour rule may be equal to or less than that for original or legally reproduced form for to attend the billing guidance webinar, small businesses. We estimated that cost a period of at least 5 years after the for a total of 3.72 hours. We estimate the of reading the rule for RO participants closure of the cost report. This median salary of a Medical Records and would be approximately $466.89 per requirement is available at 42 CFR Health Information Technician is $19.40 entity with a total cost of approximately per hour, at 100 percent fringe benefit 482.24(b)(1). Given these existing $1,354,000 (2,900 eligible entities × for a total of $38.80, using the wage requirements, we do not believe that the $466.89/participant). In sum, we information from the BLS.150 The total audit or record retention requirement in estimate that reading the RO Model rule, cost of learning the billing system for the RO Model or the ETC Model will learning the RO billing system, and the RO Model thus is $144.34 per create an additional burden or impact submitting quality measures and participant, or approximately $167,000 on participants. clinical data to the RO Model would Similarly, monitoring and compliance cost approximately $1,000 per RO 146 Da˛browska-Bender M, Dykowska G, Zuk W, et requirements for the RO Model and the participant, and collectively cost al. 2018. ‘‘The impact on quality of life of dialysis ETC Model would not diverge from approximately $1,156,000 across the patients with renal insufficiency.’’ Patient Prefer general monitoring requirements for 1,157 RO participants, and an additional Adherence 12: 577–583. Medicare Part B providers. We believe 147 Makkar V, Kumar M, Mahajan R, Khaira NS. $814,000 for those RO providers who 2015. ‘‘Comparison of Outcomes and Quality of Life that the requirements in this section do read the rule, but are not ultimately between Hemodialysis and Peritoneal Dialysis not add additional burden or impose selected as RO participants, for a total Patients in Indian ESRD Population.’’ J Clin Diagn regulatory impact on participants. cost $1,970,000. Similarly, we base our Res. 9(3): OC28–OC31 The model evaluation for both the RO 148 Van Eps CL, Jeffries JK, Johnson DW, et al. estimate for the cost of reading the 2010. ‘‘Quality of life and alternate nightly Model and the ETC Model would likely proposed rule for ETC participants on nocturnal home hemodialysis.’’ Hemodial include beneficiaries and providers the same cost per participant as used for Int.14(1):29–38. completing surveys. Burden for these the RO Model, that is, $466.89 per 149 https://aspe.hhs.gov/system/files/pdf/242926/ surveys will depend on the length, entity. We assume that all ESRD HHS_RIAGuidance.pdf. complexity, and frequency of surveys 150 For the RO Model, we use the estimated facilities and managing clinicians will median hourly wage of $19.40 per hour, plus 100 administered as needed to ensure read the rule, even though only a subset percent overhead and fringe benefits. Estimating the confidence in the survey findings. We of each category would participate in hourly wage is necessarily a rough adjustment, both would make an effort to minimize the the Model. Therefore, the collective cost because fringe benefits and overhead costs vary length, complexity, and frequency of the significantly from employer-to-employer and will be $6,714,000 (14,380 entities because methods of estimating these costs vary surveys. A typical survey on average reading the rule (7,097 ESRD facilities widely from study-to-study. Nonetheless, we would require about 20 minutes of the plus 7,283 Managing Clinicians) times believe that doubling the hourly wage rate to respondent’s time. In other evaluations $466.89). estimate total cost is a reasonably accurate of models where a survey is required, estimation method and allows for a conservative 5. Regulatory Flexibility Act (RFA) estimate of hourly costs. https://www.bls.gov/ooh/ the frequency of surveys varies from a Healthcare/Medical-records-and-health- minimum of one round of surveys to The RFA, as amended, requires information-technicians.htm. annual surveys. agencies to analyze options for

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regulatory relief of small entities, if a PGPs would be reduced by 5.9 percent using the wage information from the rule has a significant impact on a and Medicare FFS payments to HOPDs BLS including overhead and fringe substantial number of small entities. For would be reduced by 4.2 percent and benefits.155 Assuming an average purposes of the RFA, small entities would not change with an April 1 start reading speed for pages relevant to the include small businesses, nonprofit date. Given that this model is limited to RO Model, we estimate that it would organizations, and small governmental only Medicare FFS beneficiaries, not take approximately 4.66 hours for the jurisdictions. As discussed in sections other payers including Medicare staff to review half of this proposed rule. VII.5.a and VII.5.b, the Secretary has Advantage and commercial insurance, For each provider that reviews the rule, considered small entities and has which combined we expect to be about the estimated cost based on the determined and certifies that this 50 to 60 percent of total HOPD and PGP expected time and salary of the person proposed rule will not have a significant revenue for RT services, we expect that reviewing the rule ($446.89 = ($95.90 * economic impact on a substantial the anticipated average impact of 4.66 hrs). number of small entities. revenue based solely on Medicare FFS We welcome public comments on our payments to be less than 1 percent. a. Radiation Oncology Model estimates and analysis of the impact of Therefore, we have determined that this the proposed rule on those small This proposed rule affects: (1) proposed rule would not have a greater entities. Radiation oncology PGPs that furnish than 5 percent impact on total revenues RT services in both freestanding on a substantial number of small b. ESRD Treatment Choices Model radiation therapy centers and HOPDs; entities. We estimate the administrative The proposed rule includes as model (2) PGPs that furnish RT services only costs of adjusting to and complying with participants: (1) Managing Clinicians; in HOPDs; (3) PGPs that are categorized the quality measure and clinical data and (2) ESRD facilities. We assume for as freestanding radiation therapy element reporting requirements the purposes of the regulatory impact centers; and (4) HOPDs. The majority of proposed in the RO Model for small analysis that the great majority of HOPDs and other RT providers and RT entities to be approximately $388.00 per Managing Clinicians would be small suppliers are small entities, either by entity per year. To estimate the costs per entities and that the greater majority of being nonprofit organizations or by small entity, we assume that a Medical ESRD facilities would not be small meeting the SBA definition of a small Records & Health Information entities. Throughout the rule we business (defined as having minimum Technician with an Hourly salary (from describe how the proposed adjustments revenues of less than $11 million to BLS) plus 100 percent fringe benefits to certain payments for dialysis-related $38.5 million in any 1 year, depending would cost $38.80/hour 153 and would services furnished to ESRD beneficiaries on the type of provider; the $38.5 report the information on quality may affect Managing Clinicians and million per year threshold is for measures and clinical data elements. We ESRD facilities participating in the ETC hospitals, whereas the $11 million per would expect submission of the 4 Model. The great majority of Managing year threshold is for other entities). quality data measures to take Clinicians are small entities by meeting (https://www.sba.gov/document/ approximately 8 hours and would the SBA definition of a small business support--table-size-standards). States require submission once a year, ($38.80 (having minimum revenues of less than and individuals are not included in the × 8.0 hours × 1 submission) = $310.40. $11 million to $38.5 million in any 1 definition of small entity. We would expect the submission of year, varying by type of provider and HHS uses an RFA threshold of at least clinical data elements to take up to an highest for hospitals) with a minimum a 5 percent impact on revenues of small hour, but occur twice a year, that is. threshold for small business size of entities to determine whether a ($38.80 × 1 hour × 2 submission) = $38.5 million (https://www.sba.gov/ proposed rule is likely to have $77.60. The burden costs per small ‘‘significant’’ impacts on small document/support--table-size- entity associated with measure and data entities.151 Throughout the rule we standardshttp://www.sba.gov/content/ reporting proposals should be small describe how the proposed changes to a small-businesssize-standards). The great because three of the four measures prospective episode payment may affect majority of ESRD facilities are not small proposed for the RO Model are already PGPs and HOPDs. entities as they are owned in whole or The RO Model would include only in use in other CMS programs; and in part of entities that do not meet the Medicare FFS beneficiaries receiving RT compliance with the Treatment SBA definition of small entities. services by selected PGPs (including Summary Communication (the measure The HDPA in the ETC Model would freestanding radiation therapy centers) not currently in use) is a best practice be a positive adjustment on payments and HOPDs. During 2018, 39 percent of that should already be the standard of for specified home dialysis and home Medicare beneficiaries with both Part A care across PGPs and HOPDs. dialysis-related services. The proposed and B coverage on average are estimated We further estimate the PPA in the ETC Model, which includes to have enrolled in Medicare Advantage administrative cost of reading and both positive and negative adjustments plans.152 PGPs and HOPDs also serve interpreting this proposed rule per small on payments for dialysis services, patients with other coverage, for entity at approximately $446.89. We would exclude ESRD facilities with example, through Medicare or expect that a medical health service fewer than 132 attributed beneficiary- commercial insurance. We believe that manager reading 250 per minutes could months during the relevant year and the on average, Medicare FFS payments to review the rule in approximately 4.66 Managing Clinicians with the lowest hours [(approximately 233 pages * 300 volume of claims for the MCP using a 151 Office of Advocacy, Small Business words/per page)/250 words per percentile based exclusion threshold. Administration. (2012). A Guide for Government minute) 154/60 minutes)]. We estimate For the remaining small entities that Agencies, How to Comply with the Regulatory the salary of a medical and health are above the exclusion threshold and Flexibility Act, Implementing the President’s Small service manager is $95.90 per hour, Business Agenda and Executive Order 13272, randomly selected for participation, the Retrieved from www.sba.gov/sites/default/files/ rfaguide_0512_0.pdf (accessed March 18, 2019). 153 https://www.bls.gov/ooh/Healthcare/Medical- 155 For the RO Model, we use an estimated 152 This figure comes from the 2018 Medicare records-and-health-information-technicians.htm. median hourly wage of $47.95 per hour, plus 100 Trustees Report, Table IV.V1, p151 from the 154 https://aspe.hhs.gov/system/files/pdf/242926/ percent overhead and fringe benefits. https:// footnote that has the A and B share. HHS_RIAGuidance.pdf. www.bls.gov/oes/current/oes119111.htm.

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design of the ETC Model would We are not preparing an analysis for the proposed policies. We solicit and incorporate a risk adjustment and a section 1102(b) of the Act because we welcome comments on our proposals, reliability adjustment to allow for the have determined, and the Secretary on the alternatives we have identified, calculation of home dialysis rates and certifies, that the proposed RO Model and on other alternatives that we should transplant rates for both small entities and ETC Model would not have a consider, as well as on the costs, and larger entities that may be owned in significant impact on the operations of benefits, or other effects of these. whole or in part by another company. a substantial number of small rural This proposed rule contains a The risk adjustment would account hospitals. proposed model specific to radiation for the underlying variation in the 6. Unfunded Mandates Reform Act oncology. It provides descriptions of the patient population of individual ESRD requirements that we propose to waive, Section 202 of the Unfunded facilities and Managing Clinicians. The identifies the proposed payment Mandates Reform Act of 1995 (UMRA) methodology to be tested, and presents risk adjustment for the home dialysis (Pub. L. 104–04, enacted on March 22, rate would be based on the most recent rationales for our decisions and, where 1995) also requires that agencies assess relevant, alternatives that were final risk score for the beneficiary, anticipated costs and benefits before calculated using the CMS–HCC considered. We carefully considered the issuing any rule whose mandates alternatives to this proposed rule, (Hierarchical Condition Category) ESRD require spending in any one year of Dialysis Model used for risk adjusting including whether the RO Model should $100 million in 1995 dollars, updated be implemented by all RT providers and payment in the Medicare Advantage annually for inflation. In 2019, that is program, as described in section RT suppliers nationwide. We concluded approximately $154 million. This that it would be best to test the model IV.C.5.b.(3) of the proposed rule. The proposed rule does not mandate any transplant rate is proposed to be risk using a subset of all RT providers and requirements for State, local, or tribal RT suppliers in order to compare them adjusted by age, as described in section governments, or for the private sector. IV.C.5.b.(3) of the proposed rule. to the RT providers and RT suppliers 7. Federalism that would not be participating in the The reliability adjustment would RO Model. create a weighted average between the Executive Order 13132 establishes This proposed rule also contains a individual ETC Participant’s home certain requirements that an agency proposed model specific to ESRD. It dialysis rate and transplant rate and the must meet when it promulgates a provides descriptions of the aggregate home dialysis rate and proposed rule (and subsequent final requirements that we propose to waive, transplant rate of the ETC Participants rule) that imposes substantial direct identifies the performance metrics and aggregation group, with the relative requirement costs on state and local payment adjustments to be tested, and weights of the two components based on governments, preempts state law, or presents rationales for our decisions, the statistical reliability of the otherwise has Federalism implications. and where relevant, alternatives that individual ETC Participant’s home This rule would not have a substantial were considered. We carefully dialysis rate and transplant rate. The direct effect on state or local considered the alternatives to this reliability adjustment allows for governments, preempt state law, or proposed rule, including whether the comparable performance rates for ESRD otherwise have a Federalism model should be implemented to facilities and Managing Clinicians implication because both the RO Model include more or fewer ESRD facilities across the size spectrum. and ETC Model are Federal payment programs impacting Federal payments and Managing Clinicians. We concluded Taken together, the proposed low only and do not implicate local that it would be best to test the model volume threshold exclusions, risk governments or state law. Therefore, the with approximately half of ESRD adjustments, and reliability adjustments requirements of Executive Order 13132 facilities and Managing Clinicians in the previously described, with the fact that are not applicable. U.S. in order to have an effective the ETC Model would affect Medicare comparison group and to provide the payment only for select services D. Reducing Regulation and Controlling best opportunity for an accurate and furnished to Medicare FFS beneficiaries, Regulatory Costs thorough evaluation of the model’s we have determined that this proposed Executive Order 13771, titled effects. rule would not have a greater than 5 Reducing Regulation and Controlling We welcome comments on our percent impact on a substantial number Regulatory Costs (82 FR 9339), was proposals and the alternatives we have of small entities. issued on January 30, 2017. This identified. 5. Effects on Small Rural Hospitals proposed rule, if finalized as proposed, F. Accounting Statement and Table is not expected to be subject to the Section 1102(b) of the Act requires requirements of E.O. 13771 because it is As required by OMB Circular A–4 CMS to prepare a RIA if a rule may have estimated to result in no more than de under Executive Order 12866 (available a significant impact on the operations of minimis costs. at http://www.whitehouse.gov/omb/ a substantial number of small rural circulars_a004_a4) in Tables 18 and 19, hospitals. This analysis must conform to E. Alternatives Considered we have prepared an accounting the provisions of section 603 of the Throughout this proposed rule, we statement showing the classification of RFA. For purposes of section 1102(b) of have identified our proposed policies transfers, benefits, and costs associated the Act, we define a small rural hospital and alternatives that we have with the provisions in this proposed as a hospital that is located outside a considered, and provided information rule. The accounting statement is based Metropolitan Statistical Area and has as to the likely effects of these on estimates provided in this regulatory fewer than 100 beds. alternatives and the rationale for each of impact analysis.

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G. Conclusion 512.100 Basis and scope. and participant-specific technical 512.110 Definitions. episode payment amounts. This analysis, together with the 512.120 Beneficiary protections. remainder of this preamble, provides 512.130 Cooperation in model evaluation Billing and Payment the Regulatory Impact Analysis of a rule and monitoring. 512.260 Billing. with a significant economic effect. As a 512.135 Audits and record retention. 512.265 Payment. result of this proposed rule, we estimate 512.140 Rights in data and intellectual 512.270 Treatment of add-on payments that the financial impact of the property. under existing Medicare payment Radiation Oncology Model and ESRD 512.150 Monitoring and compliance. systems. 512.160 Remedial action. Treatment Choices Model proposed here Data Reporting would be net federal savings of $429 512.165 Innovation center model million ($419 million with an April 1 termination by CMS. 512.275 Quality measures, clinical data, 512.170 Limitations on review. and reporting. start date) over a 5 year performance 512.180 Miscellaneous provisions on period (2020 through 2024). bankruptcy and other notifications. Medicare Program Waivers In accordance with the provisions of Subpart B—Radiation Oncology Model 512.280 RO Model Medicare program Executive Order 12866, this rule was waivers. reviewed by the Office of Management General Reconciliation and Budget. 512.200 Basis and scope of subpart. 512.205 Definitions. 512.285 Reconciliation process. List of Subjects in 42 CFR Part 512 512.290 Timely error notice and Administrative practice and RO Model Participation reconsideration review process. procedure, Health facilities, Medicare, 512.210 RO participants and geographic Subpart C—ESRD Treatment Choices Model Reporting and recordkeeping areas. requirements. 512.215 Beneficiary population. General 512.217 Identification of individual 512.300 Basis and scope. ■ For the reasons set forth in the practitioners. 512.310 Definitions. preamble and under the authority at 42 512.220 RO participant compliance with U.S.C. 1302, 1315(a), and 1395hh, the RO Model requirements. ESRD Treatment Choices Model Scope and Centers for Medicare & Medicaid 512.225 Beneficiary notification. Participants Services proposed to amend 42 CFR Scope of Episodes Being Tested 512.320 Duration. chapter IV by adding part 512 to read as 512.230 Criteria for determining cancer 512.325 Participant selection and follows: types. geographic areas. 512.330 Beneficiary notification. PART 512—RADIATION ONCOLOGY 512.235 Included RT services. 512.240 Included modalities. Home Dialysis Payment Adjustment MODEL AND END STAGE RENAL 512.245 Scope of episodes. DISEASE TREATMENT CHOICES 512.340 Payments subject to the facility MODEL Pricing Methodology HDPA. 512.250 Determination of national base 512.345 Payments subject to the clinician Subpart A—General Provisions Related to rates. HDPA. Innovation Center Models 512.255 Determination of participant- 512.350 Schedule of home dialysis payment Sec. specific professional episode payment adjustments.

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Performance Payment Adjustment and 14(d) of the Securities Exchange Act Medically necessary means reasonable 512.355 Schedule of performance of 1934) of beneficial ownership (within and necessary for the diagnosis or assessment and performance payment the meaning of Rule 13d–3 promulgated treatment of an illness or injury, or to adjustment. under the Securities Exchange Act of improve the functioning of a malformed 512.360 Beneficiary population and 1934), of beneficial ownership (within body member. attribution. the meaning of Rule 13d–3 promulgated Model beneficiary means a beneficiary 512.365 Performance assessment. attributed to a model participant or 512.370 Benchmarking and scoring. under the Securities Exchange Act of 512.375 Payments subject to adjustment. 1934), directly or indirectly, of voting otherwise included in an Innovation 512.380 PPA amounts and schedule. securities of the model participant Center model under the terms of this 512.385 PPA exclusions. representing more than 50 percent of the part. 512.390 Notification and targeted review. model participant’s outstanding voting Model participant means an Quality Monitoring securities or rights to acquire such individual or entity that is identified as securities; a participant in the Innovation Center 512.395 Quality measures. (2) The acquisition of the model model under the terms of this part. Medicare Program Waivers participant by any individual or entity; Model-specific payment means a 512.397 ETC Model Medicare program (3) The sale, lease, exchange or other payment made by CMS only to model waivers. transfer (in one transaction or a series of participants, or a payment adjustment Authority: 42 U.S.C. 1302, 1315(a), and transactions) of all or substantially all of made only to payments made to model 1395hh. the assets of the model participant; or participants, under the terms of the (4) The approval and completion of a Innovation Center model that is not Subpart A—General Provisions plan of liquidation of the model applicable to any other providers or Related to Innovation Center Models participant, or an agreement for the sale suppliers. or liquidation of the model participant. Provider means a ‘‘provider of § 512.100 Basis and scope. services’’ defined under section 1861(u) (a) Basis. This subpart implements Covered services means the scope of health care benefits described in of the Act and codified in the definition certain general provisions for the of ‘‘provider’’ at § 400.202 of this Radiation Oncology Model sections 1812 and 1832 of the Act for which payment is available under Part chapter. implemented under subpart B (RO Supplier means a supplier as defined A or Part B of Title XVIII of the Act. Model) and the End-Stage Renal Disease in section 1861(d) of the Act and Days means calendar days. (ESRD) Treatment Choices Model codified at § 400.202 of this chapter. implemented under subpart C (ETC Descriptive model materials and US Territories means American Model), collectively referred to in this activities means general audience Samoa, the Federated States of subpart as Innovation Center models. materials such as brochures, Micronesia, Guam, the Marshall Islands, Except as specifically noted in this part, advertisements, outreach events, letters and the Commonwealth of the Northern the regulations do not affect the to beneficiaries, web pages, mailings, Mariana Islands, Palau, Puerto Rico, applicability of other provisions social media, or other materials or U.S. Minor Outlying Islands, and the affecting providers and suppliers under activities distributed or conducted by or U.S. Virgin Islands. Medicare Fee-For-Service (FFS), on behalf of the model participant or its including provisions regarding downstream participants when used to § 512.120 Beneficiary protections. payment, coverage, or program integrity. educate, notify, or contact beneficiaries (a) Beneficiary freedom of choice. (1) (b) Scope. The regulations in this regarding the Innovation Center model. The model participant and its subpart apply to model participants in The following communications are not downstream model participants must the RO Model (except as otherwise descriptive model materials and not restrict beneficiaries’ ability to noted in § 512.160(b)(6)) and to model activities: Communications that do not choose to receive care from any provider participants in the ETC Model. This directly or indirectly reference the or supplier. subpart sets forth the following: Innovation Center model (for example, (2) The model participant and its (1) Basis and scope. information about care coordination downstream model participants must (2) Beneficiary protections. generally); information on specific not commit any act or omission, nor (3) Model participant requirements for medical conditions; referrals for health adopt any policy that inhibits participation in model evaluation and care items and services; and any other beneficiaries from exercising their monitoring, and record retention. materials that are excepted from the freedom to choose to receive care from (4) Rights in data and intellectual definition of ‘‘marketing’’ as that term is any provider or supplier or from any property. defined at 45 CFR 164.501. health care provider who has opted out (5) Monitoring and compliance. Downstream participant means an of Medicare. Notwithstanding the (6) Remedial action and termination individual or entity that has entered foregoing, the model participant and its by CMS. into a written arrangement with a model downstream model participants may (7) Limitations on review. participant pursuant to which the communicate to model beneficiaries the (8) Miscellaneous provisions on downstream participant engages in one benefits of receiving care with the bankruptcy and notification. or more Innovation Center model model participant, if otherwise § 512.110 Definitions. activities. consistent with the requirements of this For purposes of this part, the Innovation Center model means the part and applicable law. following terms are defined as follows RO Model implemented under subpart (b) Availability of services. (1) The unless otherwise stated: B or the ETC Model implemented under model participant and its downstream Beneficiary means an individual who subpart C. participants must continue to make is enrolled in Medicare FFS. Innovation Center model activities medically necessary covered services Change in control means any of the means any activities impacting the care available to beneficiaries to the extent following: of model beneficiaries related to the test required by applicable law. Model (1) The acquisition by any ‘‘person’’ of the Innovation Center model under beneficiaries and their assignees retain (as such term is used in sections 13(d) the terms of this part. their rights to appeal claims in

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accordance with part 405, subpart I of § 512.150, including producing such notifies the model participant at least 30 this chapter. data as may be required by CMS to days before the normal disposition date; (2) The model participant and its evaluate or monitor the Innovation or downstream participants must not take Center model, which may include (ii) There has been a termination, any action to select or avoid treating protected health information as defined dispute, or allegation of fraud or similar certain Medicare beneficiaries based on in 45 CFR 160.103 and other fault against the model participant or its their income levels or based on factors individually-identifiable data. downstream participants, in which case that would render the beneficiary an the records must be maintained for an ‘‘at-risk beneficiary’’ as defined at § 512.135 Audits and record retention. additional six 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 pursuant to paragraph (c)(1)(i) of model participant’s or downstream regarding implementation of an this section or there has been a participant’s financial or quality Innovation Center model. 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 downstream participants must include of the implementation of the Innovation § 512.140 Rights in data and intellectual the following statement on all Center model, including without property. descriptive model materials and limitation, documents and other (a) CMS may use any data obtained activities: ‘‘The statements contained in evidence regarding all of the following: under §§ 512.130, 512.135, and 512.150 this document are solely those of the (1) The model participant’s and its to evaluate and monitor the Innovation authors and do not necessarily reflect downstream participants’ compliance Center model and may disseminate the views or policies of the Centers for with the terms of the Innovation Center quantitative and qualitative results and Medicare & Medicaid Services (CMS). model, including this subpart. successful care management techniques, The authors assume responsibility for (2) The accuracy of model-specific including factors associated with the accuracy and completeness of the payments made under the Innovation performance, to other providers and information contained in this Center model. suppliers and to the public. Data to be document.’’ (3) The model participant’s payment disseminated may include patient de- (3) The model participant and its of amounts owed to CMS under the identified results of patient experience downstream participants must retain Innovation Center model. of care and quality of life surveys, as copies of all written and electronic (4) Quality measure information and well as patient de-identified measure descriptive model materials and the quality of services performed under results calculated based upon claims, activities and appropriate records for all the terms of the Innovation Center medical records, and other data sources. other descriptive model materials and model, including this subpart. (b) Notwithstanding any other activities in a manner consistent with (5) Utilization of items and services provision of this part, all data that has § 512.135(c). furnished under the Innovation Center been confirmed by CMS to be (4) CMS reserves the right to review, model. proprietary trade secret information and or have a designee review, descriptive (6) The ability of the model technology of the model participant or model materials and activities to participant to bear the risk of potential its downstream participants will not be determine whether or not the content is losses and to repay any losses to CMS, released by CMS or its designee(s) materially inaccurate or misleading. as applicable. without the express written consent of This review would take place at a time (7) Patient safety. the model participant or its downstream and in a manner specified by CMS once (8) Other program integrity issues. participant, unless such release is the descriptive model materials and (c) Record retention. (1) The model required by law. activities are in use by the model participant and its downstream (c) If the model participant or its participant. participants must maintain the downstream participant wishes to documents and other evidence protect any proprietary or confidential § 512.130 Cooperation in model evaluation described in paragraph (b) of this information that it submits to CMS or its and monitoring. section and other evidence for a period designee, the model participant or its The model participant and its of six years from the last payment downstream participant must label or downstream participants must comply determination for the model participant otherwise identify the information as with the requirements of § 403.1110(b) under the Innovation Center model or proprietary or confidential. Such of this chapter and must otherwise from the date of completion of any assertions will be subject to review and cooperate with CMS’ model evaluation audit, evaluation, inspection, or confirmation by CMS prior to CMS’ and monitoring activities as may be investigation, whichever is later, acting upon such assertions. necessary to enable CMS to evaluate the unless— Innovation Center model in accordance (i) CMS determines there is a special § 512.150 Monitoring and compliance. with section 1115A(b)(4) of the Act and need to retain a particular record or (a) Compliance with laws. The model to conduct monitoring activities under group of records for a longer period and participant and each of its downstream

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participants must comply with all (4) Notwithstanding the foregoing, (8) Has failed to demonstrate applicable laws and regulations. CMS may perform unannounced site improved performance following any (b) CMS monitoring and compliance visits at the office of the model remedial action imposed under this activities. (1) CMS may conduct participant and any of its downstream section. monitoring activities to ensure participants at any time to investigate (b) Remedial actions. If CMS compliance by the model participant concerns about the health or safety of determines that one or more grounds for and each of its downstream participants beneficiaries or other patients or other remedial action described in paragraph with the terms of the Innovation Center program integrity issues. (a) of this section has taken place, CMS model including this subpart. Such (5) Nothing in this part shall be may take one or more of the following monitoring activities may include, construed to limit or otherwise prevent remedial actions: without limitation— CMS from performing site visits (1) Notify the model participant and, (i) Documentation requests sent to the permitted or required by applicable law. if appropriate, require the model model participant and its downstream (d) Right to correct. If CMS discovers participant to notify its downstream participants, including surveys and that it has made or received an incorrect participants of the violation. questionnaires; model-specific payment under the terms (2) Require the model participant to (ii) Audits of claims data, quality of the Innovation Center model, CMS provide additional information to CMS measures, medical records, and other may make payment to, or demand or its designees. data from the model participant and its payment from, the model participant. (3) Subject the model participant to downstream participants; (e) OIG authority. Nothing contained additional monitoring, auditing, or both. (4) Prohibit the model participant (iii) Interviews with members of the in the terms of the Innovation Center from distributing model-specific staff and leadership of the model Model or this part limits or restricts the participant and its downstream payments, as applicable; authority of the HHS Office of Inspector (5) Require the model participant to participants; General or any other Federal (iv) Interviews with beneficiaries and terminate, immediately or by a deadline Government authority, including its their caregivers; specified by CMS, its agreement with a authority to audit, evaluate, investigate, (v) Site visits to the model participant downstream participant with respect to or inspect the model participant or its and its downstream participants, the Innovation Center model. downstream participants for violations performed in a manner consistent with (6) In the ETC Model only, terminate of any statutes, rules, or regulations § 512.150(c); the ETC Participant from the ETC (vi) Monitoring quality outcomes and administered by the Federal Model; clinical data, if applicable; and Government. (7) Require the model participant to (vii) Tracking patient complaints and § 512.160 Remedial action. submit a corrective action plan in a form appeals. and manner and by a deadline specified (2) In conducting monitoring and (a) Grounds for remedial action. CMS by CMS. oversight activities, CMS or its may take one or more remedial actions (8) Discontinue the provision of data designees may use any relevant data or described in paragraph (b) of this sharing and reports to the model information including without section if CMS determines that the participant. limitation all Medicare claims model participant or a downstream (9) Recoup model-specific payments. submitted for items or services participant: (10) Reduce or eliminate a model- furnished to model beneficiaries. (1) Has failed to comply with any of specific payment otherwise owed to the (c) Site visits. (1) In a manner the terms of the Innovation Center model participant. consistent with § 512.130, the model Model, including this subpart. (11) Such other action as may be participant and its downstream (2) Has failed to comply with any permitted under the terms of this part. participants must cooperate in periodic applicable Medicare program requirement, rule, or regulation. § 512.165 Innovation center model site visits performed by CMS or its termination by CMS. (3) Has taken any action that threatens designees in order to facilitate the (a) CMS may terminate an Innovation evaluation of the Innovation Center the health or safety of a beneficiary or other patient. Center model for reasons including, but model and the monitoring of the model not limited to, the following: participant’s compliance with the terms (4) Has submitted false data or made false representations, warranties, or (1) CMS determines that it no longer of the Innovation Center model, has the funds to support the Innovation including this subpart. certifications in connection with any aspect of the Innovation Center model. Center model. (2) To the extent practicable, CMS or (2) CMS terminates the Innovation (5) Has undergone a change in control its designee will provide the model Center model in accordance with that presents a program integrity risk. participant or downstream participant section 1115A(b)(3)(B) of the Act. with no less than 15 days advance (6) Is subject to any sanctions of an (b) If CMS terminates an Innovation notice of any site visit. To the extent accrediting organization or a Federal, Center model, CMS will provide written practicable, CMS will attempt to state, or local government agency. notice to the model participant accommodate a request for particular (7) Is subject to investigation or action specifying the grounds for model dates in scheduling site visits. However, by HHS (including the HHS Office of termination and the effective date of the model participant or downstream Inspector General and CMS) or the such termination. participant may not request a date that Department of Justice due to an is more than 60 days after the date of the allegation of fraud or significant § 512.170 Limitations on review. initial site visit notice from CMS. misconduct, including being subject to There is no administrative or judicial (3) The model participant and its the filing of a complaint or filing of a review under sections 1869 or 1878 of downstream participants must ensure criminal charge, being subject to an the Act or otherwise for all of the that personnel with the appropriate indictment, being named as a defendant following: responsibilities and knowledge in a False Claims Act qui tam matter in (a) The selection of models for testing associated with the purpose of the site which the Federal Government has or expansion under section 1115A of the visit are available during all site visits. intervened, or similar action. Act.

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(b) The selection of organizations, made under the terms of the model and (6) Program waivers issued for RO sites, or participants, including model all administrative or judicial review participant use. participants, to test the Innovation proceedings regarding model-specific (7) Data reporting requirements. Center models selected, including a payments between the model (8) Payment reconciliation and decision by CMS to remove a model participant and CMS have been fully appeals processes. participant or to require a model and finally resolved with respect to that (c) Applicability. RO participants are participant to remove a downstream model. The notice to CMS must be subject to the general provisions for participant from the Innovation Center addressed to the CMS Office of Innovation Center models specified in model. Financial Management at 7500 Security subpart A of this part 512 and in subpart (c) The elements, parameters, scope, Boulevard, Mailstop C3–01–24, K of part 403 of this chapter. and duration of such Innovation Center Baltimore, MD 21244 or such other § 512.205 Definitions. models for testing or dissemination, address as may be specified on the CMS including without limitation the website for purposes of receiving such For purposes of this subpart, the following: notices. following definitions apply: (1) The selection of quality (b) Notice of legal name change. A Aggregate quality score (AQS) means performance standards for the model participant must furnish written the numeric score calculated for each Innovation Center model by CMS. notice to CMS at least 60 days before RO participant based on its performance (2) The assessment by CMS of the any change in its legal name becomes on, and reporting of, proposed quality quality of care furnished by the model effective. The notice of legal name measures and clinical data. The AQS is participant. change must be in a form and manner used to determine the amount of a RO (3) The attribution of model specified by CMS and must include a participant’s quality reconciliation beneficiaries to the model participant by copy of the legal document effecting the payment amount. CMS, if applicable. name change, which must be Clean period means the 28-day period (d) Determinations regarding budget authenticated by the appropriate state after an episode has ended, during neutrality under section 1115A(b)(3) of official. which time a RO participant must bill the Act. (c) Notice of change in control. A for medically necessary RT services (e) The termination or modification of model participant must furnish written furnished to the RO beneficiary in the design and implementation of an notice to CMS in a form and manner accordance with Medicare FFS billing Innovation Center model under section specified by CMS at least 90 days before rules. 1115A(b)(3)(B) of the Act. any change in control becomes effective. Core Based Statistical Area (CBSA) (f) Determinations about expansion of If CMS determines, in accordance with means a statistical geographic area, the duration and scope of an Innovation § 512.160(a)(5), that a model based on the definition as identified by Center model under section 1115A(c) of participant’s change in control would the Office of Management and Budget, the Act, including the determination present a program integrity risk, CMS with a population of at least 10,000, that an Innovation Center model is not may take remedial action against the which consists of a county or counties expected to meet criteria described in model participant under § 512.160(b). anchored by at least one core (urbanized paragraph (a) or (b) of such section. CMS may also require immediate area or urban cluster), plus adjacent reconciliation and payment of all counties having a high degree of social § 512.180 Miscellaneous provisions on and economic integration with the core bankruptcy and other notifications. monies owed to CMS by a model participant that is subject to a change in (as measured through commuting ties (a) Notice of bankruptcy. If the model control. with the counties containing the core). participant has filed a bankruptcy Discount factor means the set petition, whether voluntary or Subpart B—Radiation Oncology Model percentage by which CMS reduces a involuntary, the model participant must participant-specific professional episode provide written notice of the bankruptcy General payment or a participant-specific to CMS and to the U.S. Attorney’s Office § 512.200 Basis and scope of subpart. technical episode payment after the in the district where the bankruptcy was (a) Basis. This subpart implements the trend factor and model-specific filed, unless final payment has been test of the Radiation Oncology (RO) adjustments have been applied but made by either CMS or the model Model under section 1115A(b) of the before beneficiary cost-sharing and participant under the terms of each Act. Except as specifically noted in this standard CMS adjustments, including model tested under section 1115A of the subpart, the regulations under this the geographic practice cost index Act in which the model participant is subpart do not affect the applicability of (GPCI) and sequestration, have been participating or has participated and all other regulations affecting providers and applied. The discount factor does not administrative or judicial review suppliers under Medicare FFS, vary by cancer type. The discount factor proceedings relating to any payments including the applicability of for the professional component is 4 under such models have been fully and regulations regarding payment, coverage percent; the discount factor for the finally resolved. The notice of and program integrity. technical component is 5 percent. bankruptcy must be sent by certified (b) Scope. This subpart sets forth the Dual participant means a RO mail no later than 5 days after the following: participant that furnishes for both the petition has been filed and must contain (1) RO Model participants. professional component and technical a copy of the filed bankruptcy petition (2) Episodes being tested under the component of RT services of an episode (including its docket number), and a list RO Model. through a freestanding radiation therapy of all models tested under section (3) Methodology for pricing and center, identified by a single TIN. 1115A of the Act in which the model quality performance. Duplicate RT service means any participant is participating or has (4) Payments and billing under the RO included RT service that is furnished to participated. This list need not identify Model. a single RO beneficiary by a RT provider a model tested under section 1115A of (5) The Model as an Advanced APM or RT supplier that did not initiate the the Act in which the model participant and MIPS APM under the Quality PC or TC of that RO beneficiary during participated if final payment has been Payment Program. the episode.

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Episode means the 90-day period that, application of the trend factor, discount a Dual participant, Professional as set forth in § 512.245, begins on the factor, adjustments, and applicable participant, or Technical participant. date of service that an individual withholds, for each of the proposed RT provider means a Medicare- practitioner under a professional included cancer types. enrolled HOPD that furnishes RT participant or a dual participant NPI means National Provider services in a 5-digit ZIP Code linked to furnishes an initial RT treatment Identifier. a selected CBSA. planning service to a RO beneficiary, Participant-specific professional RT supplier means a Medicare- provided that a technical participant or episode payment means a payment, enrolled PGP or freestanding radiation the same dual participant furnishes a which is calculated by CMS as set forth therapy center that furnishes RT technical component RT service to the in § 512.255 and which is paid by CMS services in a 5-digit ZIP Code linked to RO beneficiary within 28 days of such to a Professional participant or Dual a selected CBSA. RT treatment planning service. participant as set forth in § 512.265, for Selected CBSA means a CBSA that HOPD means hospital outpatient the provision of the professional has been randomly-selected by CMS department. component to a RO beneficiary during under § 512.210(c). Included cancer types means the an episode. Technical component (TC) means the cancer types determined by the criteria Participant-specific technical episode included RT services that are not set forth in § 512.230, which are payment means a payment, which is furnished by a physician, including the included in the RO Model test. calculated by CMS as set forth in provision of equipment, supplies, Included RT services means the RT § 512.255 and which is paid by CMS to personnel, and administrative costs services identified at § 512.235, which a Technical participant or Dual related to RT services. are included in the RO Model test. participant in accordance with Technical participant means a RO Incomplete episode means the § 512.265, for the provision of the participant that is a Medicare-enrolled circumstances in which an episode does technical component to a RO HOPD or freestanding radiation therapy not occur because— beneficiary during an episode. center, identified by a single CMS (1) A Technical participant or a Dual Performance year (PY) means the 12- Certification Number (CCN) or TIN, participant does not furnish a technical month period beginning on January 1 which furnishes only for the TC of an component to a RO beneficiary within and ending on December 31 of each year episode. 28 days following a Professional during the model performance period. TIN stands for Taxpayer Identification participant or the Dual participant PGP means physician group practice. Number. furnishing an RT treatment planning Professional component (PC) means Trend factor means an adjustment service to that RO beneficiary; the included RT services that may only applied to the national base rates that (2) Traditional Medicare stops being be furnished by a physician. updates those rates to reflect current the primary payer at any point during Professional participant means a RO trends in the OPPS and PFS rates for RT the relevant 90-day period for the RO participant that is a Medicare-enrolled services. beneficiary; or PGP identified by a single TIN that True-up means the process to (3) A RO beneficiary stops meeting furnishes only the PC of an episode. calculate additional payments or the beneficiary population criteria Radiotherapy (RT) services are the repayments for incomplete episodes and under § 512.215(a) or triggers the treatment planning, technical duplicate RT services that are identified beneficiary exclusion criteria under preparation, special services (such as after claims run-out. § 512.215(b) before the technical simulation), treatment delivery, and component of an episode initiates. treatment management services RO Model Participation Individual practitioner means a associated with cancer treatment that Medicare-enrolled physician (identified use high doses of radiation to kill cancer § 512.210 RO participants and geographic areas. by an NPI) who furnishes RT services to cells and shrink tumors. Medicare FFS beneficiaries, and have Reconciliation payment means a (a) RO participants. (1) Unless reassigned their billing rights to the TIN payment made by CMS to a RO otherwise specified in paragraph (b) of of a RO participant. participant, as determined in this section, any Medicare-enrolled Individual practitioner list means a accordance with § 512.285. PGP, freestanding radiation therapy list of individual practitioners who Repayment amount means the center, or HOPD that furnishes included furnish RT services under the TIN of a amount owed by a RO participant to RT services in a 5-digit ZIP Code linked Dual participant or a Professional CMS, as determined in accordance with to a selected CBSA to a RO beneficiary participant, which is annually compiled § 512.260. for an episode that begins on or after by CMS and which the RO participant RO beneficiary means a Medicare FFS January 1, 2020, and ends on or before must review, revise, and certify in beneficiary who meets all of the December 31, 2024, must participate in accordance with § 512.217. The beneficiary inclusion criteria at the RO Model. individual practitioner list is used for § 512.215(a) and who does not trigger (b) Participant exclusions. A PGP, the RO Model as a Participation List as any of the beneficiary exclusion criteria freestanding radiation therapy center, or defined in § 414.1305 of this chapter. at § 512.215(b). HOPD will be excluded from Model performance period means, the Reconciliation report means the participation in the RO Model if it— date the RO Model begins through annual report issued by CMS to a RO (1) Furnishes RT services only in December 31, 2024, the last date during participant for each performance year, Maryland; which episodes under the Model must which specifies the RO participant’s (2) Furnishes RT services only in be completed. No new episodes may reconciliation payment amount or Vermont; begin after October 3, 2024 in order for repayment amount. (3) Furnishes RT services only in U.S. all episodes to be completed by RO participant means a Medicare- Territories; December 31, 2024. enrolled PGP, freestanding radiation (4) Is classified as an ambulatory National base rate means the total therapy center, or HOPD that surgery center (ASC), critical access payment amount for the relevant participates in the RO Model pursuant hospital (CAH), or Prospective Payment component of an episode, before to § 512.210. A RO participant may be System (PPS)-exempt cancer hospital; or

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(5) Participates in or is identified by In the event that a RO beneficiary dies (2) Removals. (i) A RO participant CMS as eligible to participate the or enters hospice during an episode, must notify CMS no later than 15 days Pennsylvania Rural Health Model. then the RO participant may receive of when an individual on the RO (c) Selected CBSAs. CMS randomly both installments of the episode participant’s individual practitioner list selects CBSAs to identify RT providers payment regardless of whether the RO ceases to be an individual practitioner. and RT suppliers to participate in the beneficiary’s course of RT has ended. The notice must be submitted in the Model through a stratified sample form and manner specified by CMS. design, allowing for participant and § 512.217 Identification of individual (ii) The removal of an individual practitioners. comparison groups to contain practitioner from the RO participant’s approximately 40 percent of all episodes (a) General. Prior to the start of each individual practitioner list is effective in eligible geographic areas (CBSAs). performance year, CMS will create and on the date specified in the notice provide to each Dual participant and furnished to CMS, but not earlier than § 512.215 Beneficiary population. Professional participant an individual 15 days before the date of the notice. If (a) Beneficiary inclusion criteria. (1) practitioner list identifying by NPI each the RO participant fails to submit a Except as provided in paragraph (b) of individual practitioner associated with timely notice of the removal, the this section, a beneficiary is included in the RO participant. removal is effective on the date of the the RO Model if the beneficiary: (b) Review of individual practitioner notice. (i) Receives included RT services in a list. Within 30 days of receipt of such (e) Update to Medicare enrollment 5-digit ZIP Code linked to a selected individual practitioner list, the RO information. The RO participant must CBSA from a RO participant during the participant must review and certify the ensure that all changes to enrollment model performance period for a cancer individual practitioner list in a form and information for an RO participant and type that meets the criteria for inclusion manner specified by CMS and in its individual practitioners, including in the RO Model; and accordance with paragraph (c) of this changes to reassignment of the right to (ii) At the time that the initial section or correct the individual receive Medicare payment, are reported treatment planning service of an episode practitioner list in accordance with to CMS consistent with § 424.516 of this is furnished by an RO participant, the paragraph (d) of this section. chapter. beneficiary— (c) List certification. (1) Within 30 (A) Is eligible for Medicare Part A and days of receipt of such individual § 512.220 RO participant compliance with enrolled in Medicare Part B; and practitioner list, and at such other times RO Model requirements. (B) Has traditional FFS Medicare as as specified by CMS, an individual with (a) RO participant-specific his or her primary payer. the authority to legally bind the RO requirements. (1) RO participants are (2) Any RO beneficiary enrolled in a participant must certify the accuracy, required to meet the Model clinical trial for RT services for which completeness, and truthfulness of the requirements to qualify for the APM Medicare pays routine costs will be individual practitioner list to the best of Incentive Payment, as applicable. included in the RO Model provided that his or her knowledge information and (2) Each Professional participant and the beneficiary satisfies all of the belief. Dual participant must ensure its beneficiary inclusion criteria in (2) All Medicare-enrolled individual individual practitioners— paragraph (a)(1) of this section. practitioners that have reassigned their (i) Discuss goals of care with each RO (b) Beneficiary exclusion criteria. A right to receive Medicare payment for beneficiary before initiating treatment beneficiary is excluded from the RO provision of RT services to the TIN of and communicate to the RO beneficiary Model if, at the initial treatment the RO participant must be included on whether the treatment intent is curative planning service the beneficiary is— the RO participant’s individual or palliative; (1) Enrolled in any Medicare managed practitioner list and each individual (ii) Adhere to nationally recognized, care organization, including but not practitioner must agree to comply with evidence-based clinical treatment limited to Medicare Advantage plans; the requirements of the RO Model guidelines when appropriate in treating (2) Enrolled in a PACE plan; before the RO participant certifies the RO beneficiaries or, alternatively, (3) Is in a Medicare hospice benefit individual practitioner list. document in the medical record the period; or (d) Changes to the individual extent of and rationale for any departure (4) Covered under United Mine practitioner list—(1) Additions. (i) A RO from these guidelines; Workers. participant must notify CMS of an (iii) Assess each RO beneficiary’s (c) Changes during an episode. (1) If addition to its individual practitioner tumor, node, and metastasis (TNM) a RO beneficiary stops meeting any of list within 15 days of when an eligible cancer stage for the CMS-specified the proposed eligibility criteria before clinician reassigns his or her rights to cancer diagnoses; the TC of the episode has been initiated, receive payment from Medicare to the (iv) Assess the RO beneficiary’s then the episode is classified as an RO participant. The notice must be performance status as a quantitative incomplete episode. Payments to RO submitted in the form and manner measure determined by the physician; participants will be retrospectively specified by CMS. (v) Send a treatment summary to each adjusted to account for incomplete (ii) If the RO participant timely RO beneficiary’s referring physician episodes during the annual submits notice to CMS, the addition of within 3 months of the end of treatment reconciliation process. an individual practitioner to the RO to coordinate care; (2) If traditional Medicare stops being participant’s individual practitioner list (vi) Discuss with each RO beneficiary an RO beneficiary’s primary payer after is effective on the date specified in the prior to treatment delivery his or her the TC of the episode has been initiated notice furnished to CMS, but no earlier inclusion in, and cost-sharing then, regardless of whether the than 15 days before the date of the responsibilities under, the RO Model; beneficiary’s course of RT treatment was notice. If the RO participant fails to and completed, the 90-day period is submit timely notice to CMS, the (vii) Perform and document Peer considered an incomplete episode and, addition of an individual practitioner to Review (audit and feedback on the RO participant may receive only the the individual practitioner list is treatment plans) for 50 percent of new first installment of the episode payment. effective on the date of the notice. patients in PY1, for 55 percent of new

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patients in PY2, for 60 percent of new to the RO beneficiary in the form and § 512.245 Scope of episodes. patients in PY3, for 65 percent of new manner specified by CMS. (a) General. Any episode that begins patients in PY4, and for 70 percent of (c) Applicability of general Innovation on or after January 1, 2020, and ends on new patients in PY5 preferably before Center provisions. The beneficiary or before December 31, 2024, will be starting treatment, but in all cases before notifications under this section are not part of the RO Model test and subject to 25 percent of the total prescribed dose descriptive model materials and the rules under this part. has been delivered and within 2 weeks activities under § 512.120(c). The (b) Death or election of hospice of the start of treatment. requirement described in § 512.120(c)(2) benefit. An episode may be included in, (3) At such times and in the form and shall not apply to the standardized and paid for under, the RO Model even manner specified by CMS, each written notice described in paragraph if the RO beneficiary dies or enters Technical participant and Dual (b) of this section. hospice during the episode. In participant must annually attest to Scope of Episodes Being Tested accordance with § 512.215(c), the RO whether it actively participates in a participant may receive both radiation oncology-specific AHRQ-listed § 512.230 Criteria for determining cancer installments of the episode payment patient safety organization (PSO) (per types. under such circumstances, regardless of their PSO Provider Service Agreement). (a) Included cancer types. CMS whether the RO beneficiary enters (b) CEHRT. (1) Each RO participant includes in the RO Model test cancer hospice before the relevant course of RT must use CEHRT, and ensure that its types that satisfy all of the following treatment has ended. individual practitioners use CEHRT, in criteria. The cancer type: (c) Clean periods. An episode must a manner sufficient to meet the (1) Is commonly treated with not be initiated for the same RO applicable requirements of the radiation; and beneficiary during a clean period. (2) Has associated current ICD–10 Advanced APM criteria codified in Pricing Methodology § 414.1415(a)(1)(i) of this chapter. Before codes that have demonstrated pricing each performance year, each RO stability. § 512.250 Determination of national base (b) Removing cancer types. CMS will participant must certify in the form and rates. remove cancer types in the RO Model if manner and by a deadline specified by CMS determines a national base rate it determines: for the PC and TC for each included CMS that it will use CEHRT throughout (1) RT is no longer appropriate to treat cancer type. National base rates are the such performance year in a manner a cancer type per nationally recognized, historical average cost for an episode of sufficient to meet the requirements set evidence-based clinical treatment care for each of the included cancer forth in § 414.1415(a)(1)(i) of this guidelines; chapter. (2) CMS discovers a ≥10 percent error types prior to the model performance (2) Within 30 days of the start of PY1, in established national baseline rates; or period. We exclude those episodes that the RO participant must certify its intent (3) The Secretary determines a cancer do not meet the criteria described in to use CEHRT throughout PY1 in a type not to be suitable for inclusion in § 512.245. From those episodes, we then manner sufficient to meet the the Model. calculate the amount CMS paid on requirements set forth in (c) ICD–10 codes for included cancer average to providers for the PC and TC § 414.1415(a)(1)(i) of this chapter. types. CMS displays on the RO Model for each of the included cancer types in website no later than 30 days prior to the HOPD setting, creating the Model’s § 512.225 Beneficiary notification. each performance year the ICD–10 national base rates. (a) General. Professional participants diagnosis codes associated with each and Dual participants must notify each § 512.255 Determination of participant- included cancer type. specific professional episode payment and RO beneficiary to whom it furnishes participant-specific technical episode § 512.235 Included RT services. included RT services that— payment amounts. (a) Only the following RT services (1) The RO participant is participating Before the start of each performance furnished using an included modality in the RO Model; year CMS calculates the amounts for identified at § 512.240 for an included (2) The RO beneficiary has the participant-specific professional episode cancer type are included RT services opportunity to decline claims data payment amounts and participant- that are paid for by CMS under sharing for care coordination and specific technical episode payment quality improvement purposes. If a RO § 512.265: (1) Treatment planning; amounts for each included cancer type beneficiary declines claims data sharing using the following: for care coordination and quality (2) Technical preparation and special services; (a) Trend factors. CMS adjusts the improvement purposes the RO national base rates for the PC and TC of participant must inform CMS within 30 (3) Treatment delivery; and, (4) Treatment management. each cancer type by calculating a days of receiving notification from the (b) All other RT services furnished by separate trend factor for the PC and TC RO beneficiary that the beneficiary is an RO participant during the model of each included cancer type. declining to have their claims data performance period will be subject to (b) Case mix adjustment. CMS shared in that manner; and Medicare FFS payment rules. establishes and applies case mix (3) Information regarding RO adjustments to the trended national base beneficiary cost-sharing responsibilities. § 512.240 Included modalities. rates for the PC and TC of each included (b) Form and manner of notification. The modalities included in the RO cancer type. These adjustments reflect Notification of the information specified Model are 3-dimensional conformal RT episode characteristics that may be in paragraph (a) of this section must be (3DCRT), intensity-modulated RT beyond the control of RO participants carried out by a RO participant by (IMRT), image-guided RT (IGRT), such as cancer type, age, sex, presence providing each RO beneficiary with a stereotactic radiosurgery (SRS), of a major procedure, death during the CMS-developed standardized written stereotactic body RT (SBRT), episode, and presence of chemotherapy. notice during the RO beneficiary’s intraoperative radiotherapy (IORT), (c) Historical experience adjustment. initial treatment planning session. The proton beam therapy (PBT), and CMS establishes and applies historical RO participants must furnish the notice brachytherapy. experience adjustments to the national

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base rates after the trend factor and case number of episodes in the rolling 3-year RO participant’s case mix, historical mix adjustment have been applied. The period used in the case mix adjustment experience, and after which the historical experience adjustments reflect for that performance year. RO discount rate and withholds have been each RO participant’s actual historical participants that continue to have fewer applied, for local cost and wage indices experience. than 60 attributed episodes in the based on where RT services are (d) Efficiency factor. The professional rolling 3-year period used in the case furnished, pursuant to existing historical experience adjustment and mix adjustment for that performance geographic adjustment processes in the technical historical experience year would continue to have OPPS and PFS. adjustment for each RO participant are participant-specific professional episode (l) Coinsurance. RO participants may weighted by an efficiency factor. The payment and technical episode payment collect beneficiary coinsurance RO participants with a professional amounts that equal the trended national payments in multiple installments via a historical experience adjustment or base rates, whereas those that have 60 payment plan. technical historical experience or more attributed episodes would have Billing and Payment adjustment with a value equal to or less participant-specific professional episode zero have a different CMS policy factor payment and technical episode payment § 512.260 Billing. than those RO participants with a amounts that equal the trended national (a) Reassignment of billing rights. professional or technical historical base rates with the case mix adjustment Each Professional participant and Dual experience adjustment of more than added. participant must ensure that its zero. (g) Discount factor. CMS deducts a individual practitioners reassign their (e) Changes in business structure. RO percentage discount from the trended billing rights to the TIN of the participants must notify CMS in writing national base rates after the case mix Professional participant or Dual of a merger, acquisition, or other new and historical experience adjustments participant. clinical or business relationship, at least have been applied. The discount factor (b) Billing under the RO Model. (1) 90 days before the effective date of the for the PC is 4 percent. The discount Professional participants and Dual change. CMS updates case mix and factor for TC is 5 percent. participants shall bill a RO Model- historical experience adjustments (h) Incorrect payment withhold. CMS specific HCPCS code and a start-of- pursuant to the relevant treatment withholds from each RO participant 2 episode modifier to indicate that the history that applies as a result of a percent from each episode payment, treatment planning service has been merger, acquisition, or other new after the trend factor, adjustments, and furnished and that an episode has been clinical or business relationship in the discount factor have been applied, in initiated. RO participant’s case mix and historical order to account for duplicate RT (2) Dual participants and Technical experience adjustment calculations from services and incomplete episodes. CMS participants shall bill a RO model- the effective date of the change. determines during the annual specific HCPCS code and start-of- (f) HOPD or freestanding radiation reconciliation process set forth at episode modifier to indicate that a therapy center with fewer than 60 § 512.285 whether a RO participant is treatment delivery service was episodes during 2015–2017. If a HOPD, eligible to receive a portion or all of the furnished. or freestanding radiation therapy center withheld amount or whether any (3) RO participant shall bill the same (identified by a CCN or TIN) meets payment is owed to CMS. RO Model-specific HCPCS code that eligibility requirements and begins to (i) Quality withhold. CMS withholds initiated the episode and an end-of- provide RT services within a selected 2 percent for the PC to the applicable episode modifier to indicate that the CBSA, but has fewer than 60 episodes trended national base rates after the case episode has ended. from 2015 to 2017 to calculate case mix mix and historical experience (c) Billing for RT services performed and historical experience adjustments, adjustments and discount factors are during a clean period. A RO participant then its participant-specific professional applied to comply with the Advanced shall bill for any medically necessary episode payment amount and APM criteria codified in RT services furnished to a RO participant-specific technical episode § 414.1415(b)(1) of this chapter which beneficiary during a clean period payment amount are equal the trended requires an Advanced APM to include pursuant to existing FFS billing national base rates in PY1. In PY2, if an quality measure results as a factor when processes in the OPPS and PFS. RO participant with fewer than 60 determining payment to participants episodes attributed to it during the 2015 under the terms of the APM. RO § 512.265 Payment. through 2017 period continues to have participants may earn back this (a) Payment for episodes. CMS pays a fewer than 60 episodes attributed to it withhold, in part or in full, based on RO participant for all included RT during the 2016 through 2018 period, their AQS. services furnished to a RO beneficiary then the RO participant’s participant- (j) Patient experience withhold. CMS during an episode as follows— specific professional episode payment withholds one percent of the technical (1) CMS pays a Professional and technical episode payment amounts episode payment amounts starting in participant a participant-specific would continue to equal the trended 2022 (PY3) to account for patient professional episode payment for the national base rates in PY2. However, if experience in the RO Model, which is professional component furnished to a the RO participant had 60 or more based on the patient-reported Consumer RO beneficiary during an episode. attributed episodes during the 2016 Assessment of Healthcare Providers and (2) CMS pays a Technical participant through 2018 period, then the RO Systems® (CAHPS®) Cancer Care a participant-specific technical episode participant’s participant-specific Radiation Therapy survey. RO payment for the technical component professional episode payment and participants may earn back this furnished to a RO beneficiary during an technical episode payment amounts for withhold, in part or in full, based on episode. PY2 would equal the trended national their results from the CAHPS® Cancer (3) CMS pays a Dual participant a base rates with the case mix adjustment Care Radiation Therapy survey. participant-specific professional episode added. In PY3 to PY5, we will (k) Geographic adjustment. CMS payment and a participant-specific reevaluate those same RO participants further adjusts the trended national base technical episode payment for the as we did in PY2 to determine the rates that have been adjusted for each professional component and technical

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component furnished to a RO (b) Participant public release of (e) PFS Relativity Adjuster. CMS beneficiary during an episode. patient de-identified information. The waives the requirement to apply the PFS (b) Payment installments. CMS makes RO participant must include the Relativity Adjuster to RO Model-specific each of the payments described in disclaimer codified at § 512.120(c)(2) on APCs for RO participants that are non- paragraph (a) of this section in two the first page of any publicly-released excepted off-campus provider-based equal installments, as follows— document, the content of which departments (PBDs) identified by (1) CMS pays one-half of a materially and substantially references section 603 of the Bipartisan Budget Act participant-specific professional episode or is materially and substantially based of 2015 (Pub. L. 114–74), which and/or one-half of the participant- upon the RO participant’s participation amended section 1833(t)(1)(B)(v) and specific technical episode payment after in the RO Model, including but not added paragraph (t)(21) to the Social the RO participant bills a RO Model- limited to press releases, journal Security Act. specific HCPCS code with a start-of- articles, research articles, descriptive (f) General payment waivers. CMS episode modifier. articles, external reports, and statistical/ waives the following sections of the Act (2) CMS pays the remaining half of a analytical materials. solely for the purposes of testing the RO participant-specific professional episode (c) Professional and Dual Model: and/or one-half of the participant- participants. Professional participants (1) 1833(t)(1)(A). specific technical episode payment after and Dual participants must report (2) 1833(t)(16)(D). the RO participant bills a RO Model- selected quality measures on all patients (3) 1848(a)(1). specific HCPCS code with an end-of- and clinical data elements, such as (4) 1869 claims appeals procedures. episode modifier. cancer stage, disease involvement, Reconciliation § 512.270 Treatment of add-on payments treatment intent and specific treatment under existing Medicare payment systems. plan information on beneficiaries § 512.285 Reconciliation process. treated for specified cancer types, in the CMS does not make separate (a) General. CMS uses the form, manner, and at a time specified by Medicare FFS payments to RO CMS. reconciliation process described in participants for any included RT paragraph (b) of this section after the services that are furnished to a RO Medicare Program Waivers end of each performance year to identify beneficiary during an episode. A RO any reconciliation payment amount participant may receive Medicare FFS § 512.280 RO Model Medicare program waivers. owed to a RO participant or any payment for items and services repayment amount owed by a RO (a) General. The Secretary shall waive furnished to a RO beneficiary during an participant to CMS. certain requirements of title XVIII of the episode, provided that any such other (b) Annual reconciliation. CMS Act as necessary solely for purposes of item or service is not an included RT conducts an annual reconciliation for testing of the RO Model. Such waivers service. each RO participant in August following apply only to the participants in the RO each performance year. Data Reporting Model. (b) Hospital Outpatient Quality (1) Reconciliation report. CMS issues § 512.275 Quality measures, clinical data, each RO participant a reconciliation and reporting. Reporting (OQR) Program. CMS waives the application of the Hospital OQR report for each performance year. Each (a) Data privacy compliance. The RO Program 2.0 percentage point reduction reconciliation report contains the participant must comply with all under section 1833(t)(17) of the Act for following: applicable laws pertaining to any only those Ambulatory Payment (i) The determination as to whether patient-identifiable data requested from Classifications (APCs) that include only the RO participant is eligible for a CMS under the terms of the Innovation RO Model-specific HCPCS codes during reconciliation payment or must make a Center model, as well as the terms of the model performance period. repayment to CMS. any agreement entered into by the RO (c) Merit-based Incentive Payment (ii) The RO participant’s participant with CMS as a condition of System (MIPS). CMS waives the reconciliation payment amount or receiving that data. These laws include requirement to apply the MIPS payment repayment amount for the relevant without limitation the standards for the adjustment factor, and, as applicable, performance year, as calculated by CMS. privacy of individually identifiable the additional MIPS payment (2) Reconciliation payments. If a RO health information and the security adjustment factor (collectively referred reconciliation report indicates that a RO standards for the protection of to as the MIPS payment adjustment participant has earned a reconciliation electronic protected health information factors) under section 1848(q)(6)(E) of payment, then CMS must issue such under the regulations promulgated the Act and § 414.1405(e) of this chapter payment to the RO participant in the under the Health Insurance Portability that may otherwise apply to payments amount specified in the reconciliation and Accountability Act of 1996 (HIPAA) made for services furnished by a MIPS report as soon as administratively and the Health Information Technology eligible clinician and billed under the possible after the reconciliation report is for Economic and Clinical Health Act professional RO Model-specific HCPCS deemed final. The RO participant is not (HITECH). The RO participant must codes. permitted to collect any beneficiary bind all downstream recipients of such (d) APM Incentive Payment. CMS cost-sharing with respect to any data in a signed writing to comply with waives the requirements of reconciliation payment received. all applicable laws pertaining to patient- § 414.1450(b) such that technical (3) Repayment amounts. If a final identifiable data provided by CMS, as component payment amounts under the reconciliation report indicates that CMS well as the terms of any agreement RO Model shall not be considered in is owed a repayment amount, then the entered into by the RO participant with calculation of the aggregate payment RO participant must make a payment to CMS as a condition of receiving that amount for covered professional CMS in the repayment amount by a data, as a condition of a downstream services as defined in section deadline specified by CMS. If the RO recipient’s receipt of the data from the 1848(k)(3)(A) of the Act for the APM participant fails to timely pay the full RO participant and the maintenance Incentive Payment made under repayment amount, CMS recoups the thereof. § 414.1450(b)(1). repayment amount from any payments

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otherwise owed by CMS to the RO CMS’ response to the timely error notice of this chapter, including patient-level participant, including Medicare is deemed final. adjustments and facility-level payments for items and services (4) CMS designates a reconsideration adjustments, and excluding any unrelated to the RO Model. official, who is a designee of CMS, who applicable training adjustment add-on is authorized to receive such requests payment amount, outlier payment § 512.290 Timely error notice and and who was not involved in the amount, and transitional drug add-on reconsideration review process. responding to the RO participant’s payment adjustment (TDAPA) amount. (a) Timely error notice. Subject to the timely error notice. The CMS Benchmark year means the 12-month limitations on review in § 512.170, if the reconsideration official makes period that begins 18 months prior to RO participant identifies a suspected reasonable efforts to notify the RO the start of a given measurement year error in the calculation of their participant and CMS in writing within (MY) from which data is used to reconciliation payment or repayment 15 days of receiving the RO participant’s construct benchmarks against which to amount or AQS for which a reconsideration review request of the score an ETC Participant’s achievement determination has not yet been deemed following: and improvement on the home dialysis to be final under the terms of the RO (i) The issues in dispute; rate and transplant rate for the purpose reconciliation report, the RO participant (ii) The briefing schedule; and of calculating the ETC Participant’s may provide written notice of the (iii) The review procedures. MPS. suspected calculation error to CMS, in (5) The CMS reconsideration official Clinician Home Dialysis Payment a form and manner and by a date and makes all reasonable efforts to complete Adjustment (Clinician HDPA) means the time specified by CMS. the on-the-record resolution review and payment adjustment to the MCP for a (1) Unless the RO participant provides issue a written determination no later Managing Clinician who is an ETC such notice, the reconciliation payment than 60 days after the submission of the Participant, for the Managing Clinician’s or repayment amount determination final position paper in accordance with home dialysis claims, as described in made under § 512.285(b)(1) is deemed the reconsideration official’s briefing §§ 512.345 and 512.350. final 30 days after it is issued. schedule. Clinician Performance Payment (2) If CMS receives a timely notice of Adjustment (Clinician PPA) means the a suspected calculation error, then CMS Subpart C—ESRD Treatment Choices payment adjustment to the MCP for a will respond in writing within 30 days Model Managing Clinician who is an ETC either to confirm that there was an error General Participant based on the Managing in the calculation or to verify that the Clinician’s MPS, as described in calculation is correct. CMS may extend § 512.300 Basis and scope. §§ 512.375(b) and 512.380. the deadline for its response upon (a) Basis. This subpart implements the Comparison geographic area(s) means written notice to the RO participant. test of the End-Stage Renal Disease those HRRs that are not selected (3) Only the RO participant may use (ESRD) Treatment Choices (ETC) Model geographic areas. the timely error notice process under section 1115A(b) of the Act. ESRD Beneficiary means a beneficiary described in this paragraph and the Except as specifically noted in this receiving dialysis or other services for reconsideration review process subpart, the regulations under this end-stage renal disease, up to and described in paragraph (b) of this subpart must not be construed to affect including the month in which the section. the applicability of other provisions beneficiary receives a kidney or kidney- (4) The RO participant must have affecting providers and suppliers under pancreas transplant. submitted a timely error notice on an Medicare FFS, including the ESRD facility means an ESRD facility issue not precluded from administrative applicability of provisions regarding as specified in § 413.171 of this chapter. or judicial review as a condition of payment, coverage, or program integrity. ETC Participant means an ESRD using the reconsideration review (b) Scope. This subpart sets forth the facility or Managing Clinician that is process described in paragraph (b) of following: required to participate in the ETC Model this section. (1) The duration of the ETC Model. pursuant to § 512.325(a). (b) Reconsideration review. (1) If the (2) The method for selecting ETC Facility home dialysis payment RO participant is dissatisfied with Participants. adjustment (Facility HDPA) means the CMS’s response to the timely error (3) The schedule and methodologies payment adjustment to the Adjusted notice, then the RO participant may for the Home Dialysis Payment ESRD PPS per Treatment Base Rate for request a reconsideration review of Adjustment and Performance Payment an ESRD facility that is an ETC CMS’s response within 10 days of the Adjustment. Participant for the ESRD facility’s home issue date of CMS’ response in a form (4) The methodology for ETC dialysis claims, as described in and manner specified by CMS. Participant performance assessment for §§ 512.340 and 512.350. (2) The reconsideration review purposes of the Performance Payment Facility performance payment request must provide a detailed Adjustment, including beneficiary adjustment (Facility PPA) means the explanation of the basis for the dispute attribution, benchmarking and scoring, payment adjustment to the Adjusted and include supporting documentation and calculating the Modality ESRD PPS per treatment base rate for an for the RO participant’s assertion that Performance Score. ESRD facility that is an ETC Participant CMS or its representatives did not (5) Monitoring and evaluation, based on the ESRD facility’s MPS, as accurately calculate the reconciliation including quality measure reporting. described in §§ 512.375(a) and 512.380. payment or repayment amount or AQS (6) Medicare payment waivers. Home dialysis payment adjustment in accordance with the terms of this (HDPA) means either the Facility HDPA subpart. § 512.310 Definitions. or the Clinician HDPA. (3) If CMS does not receive a request For purposes of this subpart, the Home dialysis rate means the rate of for reconsideration from the RO following definitions apply. ESRD Beneficiaries attributed to the participant within 10 days of the issue Adjusted ESRD PPS per treatment ETC Participant who dialyzed at home date of CMS’ response to the RO base rate means the per treatment during the relevant MY, as described in participant’s timely error notice, then payment amount as defined in § 413.230 § 512.365(b).

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Hospital referral regions (HRRs) number as defined by the Internal Home Dialysis Payment Adjustment means the regional markets for tertiary Revenue Service in 26 CFR 301.6109–1. § 512.340 Payments subject to the facility medical care derived from Medicare Transplant rate means the rate of claims data as defined by the Dartmouth HDPA. ESRD beneficiaries and, if applicable, Atlas Project at https:// pre-emptive transplant beneficiaries CMS adjusts the Adjusted ESRD PPS www.dartmouthatlas.org/. attributed to the ETC Participant who per Treatment Base Rate by the Facility Managing clinician means a received a kidney or kidney-pancreas HDPA on claim lines with Type of Bill Medicare-enrolled physician or non- 072X, and with condition codes 74, 75, physician practitioner who furnishes transplant during the MY, as described in § 512.365(c). 76, or 80, when the claim is submitted and bills the MCP for managing one or by an ESRD facility that is an ETC more adult ESRD beneficiaries. ESRD Treatment Choices Model Scope Participant with a claim through date Measurement year (MY) means the 12- and Participants during a calendar year (CY) subject to month period for which achievement adjustment as described in § 512.350 and improvement on the home dialysis § 512.320 Duration. and the beneficiary is 18 years of age or rate and transplant rate are assessed for CMS will apply the payment older during the entire month of the the purpose of calculating the ETC adjustments described in this subpart Participant’s MPS and corresponding claim. under the ETC Model to claims with PPA. Each MY included in the ETC claim through dates beginning January § 512.345 Payments subject to the Model and its corresponding PPA clinician HDPA. Period are specified in § 512.355(c). 1, 2020, and ending June 30, 2026. CMS adjusts the amount otherwise Modality performance score (MPS) § 512.325 Participant selection and means the numeric performance score geographic areas. paid under Part B with respect to MCP calculated for each ETC Participant claims on claim lines with CPT codes based on the ETC Participant’s home (a) Selected participants. All 90965 and 90966 by the Clinician HDPA dialysis rate and transplant rate, as Medicare-certified ESRD facilities and when the claim is submitted by a described in § 512.370(d), which is used Medicare-enrolled Managing Clinicians Managing Clinician who is an ETC to determine the amount of the ETC located in a selected geographic area are Participant with a claim through date Participant’s PPA, as described in required to participate in the ETC during a CY subject to adjustment as § 512.380. Model. described in § 512.350 and the Monthly capitation payment (MCP) (b) Selected geographic areas. CMS beneficiary is 18 years of age or older means the monthly capitated payment establishes the selected geographic areas during the entire month of the claim. made for each ESRD Beneficiary to by selecting a random sample of 50 § 512.350 Schedule of home dialysis cover all routine professional services percent of HRRs, stratified by Census- related to treatment of the patient’s payment adjustments. defined regions (Northeast, South, renal condition furnished by the Midwest, and West), as well as all HRRs CMS adjusts the payments specified physician or non-physician practitioner in § 512.340 by the Facility HDPA and as specified in § 414.314 of this chapter. for which at least 20 percent of the component zip codes are located in adjusts the payments specified in National Provider Identifier (NPI) Maryland. CMS excludes all U.S. § 512.345 by the Clinician HDPA, means the standard unique health according to the following schedule: identifier used by health care providers Territories from the selected geographic for billing payors, assigned by the areas. (a) CY 2020: +3 percent National Plan and Provider § 512.330 Beneficiary notification. (b) CY 2021: +2 percent Enumeration System (NPPES) in 45 CFR (c) CY 2022: +1 percent part 162. (a) General. ETC Participants must Performance payment adjustment prominently display informational Performance Payment Adjustment (PPA) means either the Facility PPA or materials in each of their office or the Clinician PPA. facility locations where beneficiaries § 512.355 Schedule of performance assessment and performance payment Performance payment adjustment receive treatment to notify beneficiaries adjustment. period (PPA Period) means the six- that the ETC Participant is participating month period during which a PPA is in the ETC Model. CMS provides the (a) Measurement Years. CMS assesses applied pursuant to § 512.380. ETC Participant with a template for ETC Participant performance on the Pre-emptive transplant beneficiary these materials, indicating the required home dialysis rate and the transplant means a beneficiary who received a content that the ETC Participant must rate during each of the MYs. The first kidney or kidney-pancreas transplant not change and places where the ETC MY begins on January 1, 2020, and the prior to beginning dialysis. Participant may insert its own original final MY ends on June 30, 2025. Selected geographic area(s) are those content. (b) Performance Payment Adjustment HRRs selected by CMS pursuant to Period. CMS adjusts payments for ETC § 512.325(b) for purposes of selecting (b) Applicability of general Innovation Participants by the PPA during each of ESRD facilities and Managing Clinicians Center model provisions. The the PPA Periods, each of which required to participate in the ETC Model requirement described in § 512.120(c) as ETC Participants. shall not apply to the CMS-provided corresponds to a MY. The first PPA Subsidiary ESRD Facility is an ESRD materials described in paragraph (a) of Period begins on July 1, 2021, and the facility owned in whole or in part by this section. All other ETC Participant final PPA Period ends on June 30, 2026. another legal entity. communications that are descriptive (c) Measurement Years and Taxpayer Identification Number (TIN) model materials and activities as Performance Payment Adjustment means a Federal taxpayer identification defined under § 512.110 must meet the Periods. MYs and PPA Periods follow number or employer identification requirements described in § 512.120(c). the schedule in Table 1 to § 512.355(c):

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§ 512.360 Beneficiary population and (5) Has elected hospice; § 512.365 Performance assessment. attribution. (6) Is receiving dialysis for acute (a) General. For each MY, CMS (a) General. Except as provided in kidney injury (AKI) only; or separately assesses the home dialysis paragraph (b) of this section, CMS rate and the transplant rate for each ETC attributes ESRD Beneficiaries to an ETC (7) Has a diagnosis of dementia. Participant based on the population of Participant for each month during a MY (c) Attribution services—(1) ESRD ESRD Beneficiaries and, if applicable, based on the ESRD Beneficiary’s receipt facility beneficiary attribution. To be pre-emptive transplant beneficiaries of services specified in paragraph (c) of attributed to an ESRD facility that is an attributed to the ETC Participant under this section during that month, for the ETC Participant for a month, an ESRD § 512.360. Information used to calculate purpose of assessing the ETC Beneficiary must have received renal the home dialysis rate and the Participant’s performance on the home dialysis services, other than renal transplant rate includes Medicare dialysis rate and transplant rate during dialysis services for AKI, during the claims data, Medicare administrative that MY. Except as provided in month from the ESRD facility. An ESRD data, and data from the Scientific paragraph (b) of this section, CMS Beneficiary is attributed to the ESRD Registry of Transplant Recipients. attributes pre-emptive transplant facility at which the ESRD Beneficiary (b) Home dialysis rate. CMS calculates beneficiaries to a Managing Clinician for received the plurality of his or her the home dialysis rate for ESRD one or more months during a MY based facilities and Managing clinicians as dialysis treatments in that month, as on the pre-emptive transplant follows. identified by claims with Type of Bill beneficiary’s receipt of services (1) ESRD facilities. The denominator 072X, with claim through dates during specified in paragraph (c)(2) of this is the total dialysis treatment section during that month, for the the month. If the ESRD Beneficiary beneficiary years for attributed ESRD purpose of assessing the Managing receives an equal number of dialysis Beneficiaries during the MY. Dialysis Clinician’s performance on the treatments from two or more ESRD treatment beneficiary years included in transplant rate during that MY. CMS facilities in a given month, CMS the denominator are composed of those attributes ESRD Beneficiaries and pre- attributes the ESRD Beneficiary to the months during which an attributed emptive transplant beneficiaries to the ESRD facility at which the beneficiary ESRD Beneficiary received maintenance ETC Participant for each month during received the earliest dialysis treatment dialysis at home or in an ESRD facility, a MY after the end of the MY. CMS that month. CMS does not attribute pre- such that one beneficiary year is attributes an ESRD Beneficiary to no emptive transplant beneficiaries to composed of 12 beneficiary months. more than one ESRD facility and no ESRD facilities. Months during which attributed ESRD more than one Managing Clinician for a (2) Managing clinician beneficiary Beneficiaries received maintenance given month during a given MY; CMS attribution. An ESRD Beneficiary is dialysis are identified by claims with attributes a pre-emptive transplant attributed to a Managing Clinician who Type of Bill 072X. The numerator is the total number of home dialysis treatment beneficiary to no more than one is an ETC Participant for a month if that beneficiary years for attributed Managing Clinician for a given MY. Managing Clinician submitted an MCP (b) Exclusions from attribution. CMS beneficiaries during the MY. Home claim for services furnished to the does not attribute an ESRD Beneficiary dialysis treatment beneficiary years beneficiary, identified with CPT codes or a pre-emptive transplant beneficiary included in the numerator are to an ETC Participant for a month if, at 90957, 90958, 90959, 90960, 90961, composed of those months during any point during the month, the ESRD 90962, 90965, or 90966, with claim which attributed ESRD Beneficiaries Beneficiary or the pre-emptive through dates during the month. A pre- received maintenance dialysis at home, transplant beneficiary— emptive transplant beneficiary is such that one beneficiary year is (1) Is not enrolled in Medicare Part B; attributed to the Managing Clinician comprised of 12 beneficiary months. (2) Is enrolled in Medicare Advantage, with whom the beneficiary had the most Months in which an attributed ESRD a cost plan, or other Medicare managed claims between the start of the MY and Beneficiary received maintenance care plan; the month in which the beneficiary dialysis at home are identified by claims (3) Does not reside in the United received the transplant for all months with Type of Bill 072X and condition States; between the start of the MY and the codes 74, 75, 76, or 80. Information used (4) Is younger than 18 years of age; month of the transplant. to calculate the ESRD facility home

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dialysis rate includes Medicare claims numerator is the total number of Database to identify any transplants data and Medicare administrative data. attributed ESRD Beneficiaries who among attributed beneficiaries that are The ESRD facility home dialysis rate is received a kidney transplant or a not identified through claims. The risk adjusted, as described in paragraph kidney-pancreas transplant at any time Managing Clinician transplant rate is (d)(1) of this section, and reliability during the MY. Kidney transplants and risk adjusted, as described in paragraph adjusted, as described in paragraph kidney-pancreas transplants are (d)(2) of this section, and reliability (e)(1) of this section. identified using claims with MS–DRG adjusted, as described in paragraph (2) Managing clinicians. The 008 or 652; claims with ICD–10 (e)(2) of this section. denominator is the total dialysis procedure codes 0TY00Z0, 0TY00Z1, (d) Risk adjustment. CMS risk adjusts treatment beneficiary years for 0TY00Z2, 0TY10Z0, 0TY10Z1, or the home dialysis rate using the attributed ESRD Beneficiaries during the 0TY10Z2; and information about methodology described in paragraph MY. Dialysis treatment beneficiary years transplants from the SRTR Database and (d)(1) of this section and risk adjusts the included in the denominator are Medicare administrative data to identify transplant rate using the methodology composed of those months during any transplants among attributed described in paragraph (d)(2) of this which an attributed ESRD Beneficiary beneficiaries that are not identified section. received maintenance dialysis at home through claims. The ESRD facility (1) The home dialysis rate for or in an ESRD facility, such that one transplant rate is risk adjusted, as Managing Clinicians and ESRD facilities beneficiary year is comprised of 12 described in paragraph (d)(2) of this is risk adjusted using the most recent beneficiary months. Months during section, and reliability adjusted, as final risk score for the beneficiary which an attributed ESRD Beneficiary described in paragraph (e)(1) of this available at the time of the calculation received maintenance dialysis are section. of the home dialysis rate, calculated identified by claims with CPT codes using the CMS–HCC (Hierarchical (2) Managing clinicians. The 90957, 90958, 90959, 90960, 90961, Condition Category) ESRD Dialysis denominator is the total dialysis 90962, 90965, or 90966. The numerator Model used for risk adjusting payment treatment beneficiary years for is the total number of home dialysis in the Medicare Advantage program. attributed ESRD Beneficiaries during the treatment beneficiary years for (2) The transplant rate is risk adjusted MY, plus the total number of attributed attributed ESRD Beneficiaries during the by beneficiary age with separate risk beneficiary years for pre-emptive MY. Home dialysis treatment coefficients for the following age transplant beneficiaries during the MY. beneficiary years included in the categories of beneficiaries, with age numerator are composed of those Dialysis treatment beneficiary years computed on the last day of each month months during which an attributed included in the denominator are of the MY: 18 to 55; 56 to 70; and 71 ESRD Beneficiary received maintenance composed of those months during to 74. The transplant rate is adjusted to dialysis at home, such that one which an attributed ESRD Beneficiary account for the relative percentage of beneficiary year is comprised of 12 received maintenance dialysis at home the population of beneficiaries beneficiary months. Months in which an or in an ESRD facility, such that one attributed to the ETC Participant in each attributed ESRD Beneficiary received beneficiary year is comprised of 12 age category relative to the national age maintenance dialysis at home are beneficiary months. Months during distribution of beneficiaries not identified by claims with CPT codes which an attributed ESRD Beneficiary excluded from attribution. 90965 or 90966. Information used to received maintenance dialysis are (e) Reliability adjustment. (1) ESRD calculate the Managing Clinician home identified by claims with CPT codes facilities. An ERSD facility’s home dialysis rate includes Medicare claims 90957, 90958, 90959, 90960, 90961, dialysis rate and transplant rate are each data and Medicare administrative data. 90962, 90965, or 90966, excluding reliability adjusted such that the ESRD The Managing Clinician home dialysis claims for beneficiaries who were 75 facility’s adjusted rate is the weighted rate is risk adjusted, as described in years of age or older at any point during average of the ESRD facility’s rate and paragraph (d)(1) of this section, and the month or were in a skilled nursing the rate of all ESRD facilities in the reliability adjusted, as described in facility during the month. Beneficiary ESRD facility’s aggregation group, paragraph (e)(2) of this section. years for pre-emptive transplant weighted based on the reliability of the (c) Transplant rate. CMS calculates beneficiaries included in the ESRD facility’s rate. The aggregation the transplant rate for ETC Participants denominator are composed of those group for a subsidiary ESRD facility as follows. months during which a pre-emptive includes all ESRD facilities owned in (1) ESRD facilities. The denominator transplant beneficiary is attributed to a whole or in part by the same legal entity is the total dialysis treatment Managing Clinician, from the beginning located in the HRR in which the ESRD beneficiary years for attributed ESRD of the MY up to and including the facility is located. The aggregation group Beneficiaries during the MY. Dialysis month of the transplant. The numerator for an ESRD facility that is not a treatment beneficiary years included in is the total number of attributed ESRD subsidiary ESRD facility includes all the denominator are composed of those Beneficiaries who received a kidney ESRD facilities located in the HRR in months during which an attributed transplant or a kidney-pancreas which the ESRD facility is located, with ESRD beneficiary received maintenance transplant during the MY, plus the the exception of subsidiary ESRD dialysis at home or in an ESRD facility, number of pre-emptive transplant facilities. such that one beneficiary year is beneficiaries attributed to the Managing (2) Managing clinicians. A Managing comprised of 12 beneficiary months. Clinician for the MY. ESRD clinician’s home dialysis rate and Months during which an attributed Beneficiaries who received a kidney transplant rate are each reliability ESRD Beneficiary received maintenance transplant or a kidney-pancreas adjusted such that the Managing dialysis are identified by claims with transplant are identified using claims clinician’s adjusted rate is the weighted Type of Bill 072X, excluding claims for with MS–DRG 008 or 652; claims with average of the Managing clinician’s rate beneficiaries who were 75 years of age ICD–10 procedure codes 0TY00Z0, and the rate of all Managing clinicians or older at any point during the month 0TY00Z1, 0TY00Z2, 0TY10Z0, in the Managing clinician’s aggregation or were in a skilled nursing facility at 0TY10Z1, or 0TY10Z2; and information group, based on the reliability of the any point during the month. The about transplants from the SRTR Managing clinician’s rate. Home dialysis

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

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§ 512.385 PPA exclusions. (2) CMS will respond to each request Medicare Program Waivers (a) ESRD facilities. CMS excludes an for targeted review timely submitted and determine whether a targeted § 512.397 ETC Model Medicare program ESRD facility that has fewer than 11 waivers. attributed beneficiary-years during a MY review is warranted. from the applicability of the Facility (3) The ETC Participant may include The following provisions are waived PPA for the corresponding PPA Period. additional information in support of the solely for purposes of testing the ETC (b) Managing Clinicians. CMS request for targeted review at the time Model. excludes a Managing Clinician who falls the request is submitted. If CMS (a)(1) Medicare payment waivers. below the low-volume threshold requests additional information from the CMS waives the requirements of described in this paragraph during a MY ETC Participant, it must be provided sections 1833(a), 1833(b), 1848(a)(1), from the applicability of the Clinician and received within 30 days of the 1881(b), and 1881(h)(1)(A) of the Act PPA for the corresponding PPA Period. request. Non-responsiveness to the only to the extent necessary to make the The low-volume threshold is set at the request for additional information may payment adjustments under the ETC bottom 5 percent of ETC Participants result in the closure of the targeted Model described in this subpart. review request. who are Managing Clinicians in terms of (2) Beneficiary cost sharing. The (4) If, upon completion of a targeted the number of beneficiary-years for payment adjustments under the ETC review, CMS finds that there was an which the Managing Clinician billed the Model described in this subpart do not error in the calculation of the ETC MCP during the MY. affect the beneficiary cost-sharing Participant’s MPS such that an incorrect amounts for Part B services furnished by § 512.390 Notification and targeted review PPA has been applied during the PPA ETC Participants under the ETC Model. (a) Notification. CMS will notify each period, CMS shall notify the ETC ETC Participant, in a form and manner Participant and must resolve any (b) Kidney Disease Education (KDE) determined by CMS, of the ETC resulting discrepancy payment that benefit waivers. CMS waives the Participant’s attributed beneficiaries, arises from the application of an following requirements of title XVIII of MPS, and PPA for a PPA Period no later incorrect PPA during the next PPA the Act solely for purposes of testing the than one month before the start of the period that begins after the notification ETC Model: applicable PPA Period. of the ETC Participant. (1) CMS waives the requirement that (b) Targeted review process. An ETC (5) Decisions based on targeted review only doctors, physician assistants, nurse Participant may request a targeted are final, and there is no further review practitioners, and clinical nurse review of the calculation of the MPS. or appeal. specialists can furnish KDE services under section 1861(ggg)(2)(A)(i) of the Requests for targeted review are limited Quality Monitoring to the calculation of the MPS, and may Act and § 410.48(c)(2)(i) of this chapter not be submitted in regards to: The § 512.395 Quality measures. to allow KDE services to be provided by methodology used to determine the CMS collects data on the two quality clinical staff under the direction of and MPS; or the establishment of the home measures below for ESRD facilities that incident to the services of the Managing dialysis rate methodology, transplant are ETC Participants to monitor for clinician who is an ETC Participant; rate methodology, achievement and changes in quality outcomes. CMS (2) CMS waives the requirement that improvement benchmarks and conducts data collection and measure the KDE is covered only for Stage IV benchmarking methodology, or PPA calculation using claims data and other chronic kidney disease (CKD) patients amounts. The process for targeted Medicare administrative data, including under section 1861(ggg)(1)(A) of the Act reviews is as follows: enrollment data: and § 410.48(b)(1) of this chapter to (1) An ETC Participant has 60 days to (a) Standardized Mortality Ratio permit beneficiaries diagnosed with submit a request for a targeted review, (SMR); NQF #0369. CKD Stage V or within the first 6 which begins on the day CMS makes (b) Standardized Hospitalization Ratio months of receiving a diagnosis of ESRD available the MPS. (SHR); NQF #1463. to receive the KDE benefit;

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(3) CMS waives the requirement that measure beneficiary knowledge about Dated: July 2, 2019. the content of the KDE sessions include chronic kidney disease and its treatment Seema Verma, the management of co-morbidities, be performed by a qualified clinician as Administrator, Centers for Medicare and including delaying the need for dialysis, part of one of the KDE sessions under Medicaid Services. under § 410.48(d)(1) of this chapter § 410.48(d)(5)(iii) of this chapter, Dated: July 9, 2019. when such services are furnished to provided that such outcomes Alex M. Azar II, beneficiaries with CKD Stage V or assessment is performed within one Secretary, Department of Health and Human ESRD, unless such content is relevant month of the final KDE session by Services. for the beneficiary; qualified staff. [FR Doc. 2019–14902 Filed 7–10–19; 4:45 pm] (4) CMS waives the requirement that an outcomes assessment designed to BILLING CODE P

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