Centers for Medicare & Medicaid Services Rule: Specialty Care Models to Improve Quality of Care, Reduce Expenditures
The rule was issued by
DATES: These regulations are effective on
FOR FURTHER INFORMATION CONTACT:
[email protected], or 1-844-711-2664 Option 5, for questions related to the Radiation Oncology Model.
[email protected], for questions related to the ESRD Treatment Choices Model.
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This final rule implements two new mandatory Medicare payment models under section 1115A of the Social Security Act--the Radiation Oncology Model (RO Model) and the End-Stage Renal Disease (ESRD) Treatment Choices Model (ETC Model).
The RO Model will promote quality and financial accountability for providers and suppliers of radiotherapy (RT).
The RO Model will be a mandatory payment model and will test whether making prospective episode payments to hospital outpatient departments (HOPD) and freestanding radiation therapy centers for RT episodes of care preserves or enhances the quality of care furnished to Medicare beneficiaries while reducing Medicare program spending through enhanced financial accountability for RO Model participants.
The ETC Model will be a mandatory payment model focused on encouraging greater use of home dialysis and kidney transplants, in order to preserve or enhance the quality of care furnished to Medicare beneficiaries while reducing Medicare expenditures.
The ETC Model adjusts Medicare payments on certain dialysis and dialysis-related claims for participating ESRD facilities and clinicians caring for beneficiaries with ESRD--or Managing Clinicians--based on their rates of home dialysis transplant waitlisting, and living donor transplants. We believe that these two models will test ways to further our goals of reducing Medicare expenditures while preserving or enhancing the quality of care furnished to beneficiaries.
SUPPLEMENTARY INFORMATION:
Current Procedural Terminology (CPT) Copyright Notice
Throughout this final rule, we use CPT(R) codes and descriptions to refer to a variety of services. We note that CPT(R) codes and descriptions are copyright 2020
I. Executive Summary and Background
A. Executive Summary
1. Purpose
The purpose of this final rule is to implement and test two new mandatory models under the authority of the
The goal for these models is to preserve or enhance the quality of care furnished to beneficiaries while reducing program spending through enhanced financial accountability for model participants. The Model performance period for the RO Model will begin on
These models will offer participants the opportunity to examine and better understand their own care processes and patterns with regard to beneficiaries receiving RT services for cancer, and beneficiaries with ESRD, respectively. We chose these focus areas for the models because, as discussed in sections III. and IV. of this final rule, we believe that participants in these models will have a significant opportunity to redesign care and improve the quality of care furnished to beneficiaries receiving these services.
We believe the models will further the agency's goal of increasing the extent to which CMS initiatives pay for value and outcomes, rather than for volume of services alone, by promoting the alignment of financial and other incentives for health care providers caring for beneficiaries receiving treatment for cancer or ESRD. Payments that are made to health care providers for assuming financial accountability for the cost and quality of care create incentives for the implementation of care redesign among model participants and other providers and suppliers.
CMS is testing several models, including voluntary models focused specifically on cancer and ESRD. The RO and ETC Models will require the participation of providers and suppliers that might not otherwise participate in these models, and will be tested in multiple geographic areas.
The models will allow CMS to test models with provider and supplier participation when there are differences in: (1) Historic care and utilization patterns; (2) patient populations and care patterns; (3) roles within their local markets; (4) volume of services; (5) levels of access to financial, community, or other resources; and (6) levels of population and health care provider density. As noted in the proposed rule, we believe that participation in these models by a large number of providers and suppliers with diverse characteristics will result in a robust data set for evaluating the models' proposed payment approaches and will stimulate the rapid development of new evidence-based knowledge. Testing these models in this manner will also allow us to learn more about patterns of inefficient utilization of health care services and how to incentivize quality improvement for beneficiaries receiving services for RT and ESRD, which could inform future model design.
We solicited public comment on our proposals, and on any alternatives considered. CMS has made a number of modifications to the formatting and language used in the regulation text (for example, to revise "pursuant to" to "under"; and "shall" to "must") to improve readability. These formatting and language changes are not intended to be substantive. Any substantive change(s) to this final rule is noted in the specific section(s) affected by the change(s).
2. Summary of the Major Provisions
a. General Provisions
The general provisions will be applicable only to participants in the RO Model and the ETC Model. We identified the general provisions based on similar requirements that have been repeatedly memorialized in various documents governing participation in existing model tests. We have made these provisions applicable to both the RO Model and ETC Model, with one exception related to termination of model participants, so that we may eliminate repetition in our regulations at 42 CFR part 512. The general provisions address beneficiary protections, model evaluation and monitoring, audits and record retention, rights in data and intellectual property, monitoring and compliance, remedial action, model termination by CMS, limitations on review, and miscellaneous provisions on bankruptcy and other notifications. These provisions are not intended to comprehensively encompass all the provisions that will apply to each model. Both the RO Model and the ETC Model have unique aspects that will require additional, more tailored provisions, including with respect to payment and quality measurement. Such model-specific provisions are described elsewhere in this final rule.
b. Radiation Oncology (RO) Model
In this rule, we are finalizing the creation and testing of a new payment model for radiation oncology, the RO Model. The intent of the RO Model is to promote quality and financial accountability for episodes of care centered on RT services. While preserving or enhancing the quality of care for Medicare beneficiaries, the RO Model will test whether prospective episode-based payments to physician group practices (PGPs), HOPDs, and freestanding radiation therapy centers for RT episodes of care will reduce Medicare expenditures. We anticipate the RO Model will benefit Medicare beneficiaries by encouraging more efficient care delivery and incentivizing higher value care across episodes of care. The RO Model will have a performance period of 5 calendar years, beginning
(1) Summary of the RO Provisions
(a) RO Model Overview
RT is a common treatment for patients undergoing cancer treatment and is typically furnished by a physician at either an HOPD or a freestanding radiation therapy center. The RO Model will include prospective payments for certain RT services furnished during a 90-day RO episode for included cancer types for certain Medicare beneficiaries. The included cancer types will be determined by the following criteria: All are commonly treated with radiation; make up the majority of all incidence of cancer types; and have demonstrated pricing stability. (See section III.C.5.a. of this final rule for more information.) This Model will not account for total cost of all care provided to the beneficiary during the 90 days of an RO episode. Rather, the payment will cover only select RT services furnished during an RO episode. Payments for RO episodes will be split into two components--the professional component (PC) and the technical component (TC). This division reflects the fact that RT professional and technical services are sometimes furnished by separate RT providers and RT suppliers and paid for through different payment systems (namely, the Medicare Physician Fee Schedule and Outpatient Prospective Payment System).
For example, under the RO Model, a participating HOPD must have at least one PGP to furnish RT services at the HOPD. A PGP will furnish the PC as a Professional participant and an HOPD will furnish the TC as a Technical participant. Both will be participants in the RO Model, furnishing separate components of the same RO episode. An RO participant may also elect to furnish both the PC and TC as a Dual participant through one entity, such as a freestanding radiation therapy center. The RO Model will test the cost-saving potential of prospective episode payments for certain RT services furnished during an RO episode and whether shorter courses of RT (that is, fewer doses, also known as fractions) will encourage more efficient care delivery and incentivize higher value care.
(b) RO Model Scope
We are finalizing criteria for the types of cancer included under the RO Model and list 16 cancer types that meet our criteria. These cancer types are commonly treated with RT and, therefore, RT services for such cancer types can be accurately priced for purposes of a prospective episode payment model. RO episodes will include most RT services furnished in HOPDs and freestanding radiation therapy centers during a 90-day period.
We are finalizing that participation in the RO Model will be mandatory for all RT providers and RT suppliers within selected geographic areas. We will use Core-Based Statistical Areas (CBSAs) delineated by the
We are including beneficiaries that meet certain criteria under the RO Model. For example, these criteria will require that a beneficiary have a diagnosis of at least one of the cancer types included in the RO Model and that the beneficiary receive RT services from a participating provider or supplier in one of the selected CBSAs. Beneficiaries who meet these criteria will be included in RO episodes.
(c) RO Model Overlap With Other CMS Programs and Models
We expect that there could be situations where a Medicare beneficiary included in an RO episode under the RO Model is also assigned, aligned, or attributed to another Innovation Center model or CMS program. Overlap could also occur among RT providers and RT suppliers at the individual or organization level, such as where a radiation oncologist or his or her PGP participates in multiple Innovation Center models. We believe that the RO Model is compatible with existing models and programs that provide opportunities to improve care and reduce spending, especially episode payment models like the Oncology Care Model. However, we will work to resolve any potential overlaps between the RO Model and other CMS models or programs that could result in repetitive services, or duplicative payment of services, and duplicative counting of savings or other reductions in expenditures.
(d) RO Model Episodes and Pricing Methodology
We are setting a separate payment amount for the PC and the TC of each cancer type included in the RO Model. The payment amounts will be determined based on national base rates, trend factors, and adjustments for each participant's case-mix, historical experience, and geographic location. The payment amount will also be adjusted for withholds for incorrect payments, quality, and starting in the third performance year (PY3), patient experience. The standard beneficiary coinsurance amounts (typically 20 percent of the Medicare-approved amount for services) and sequestration will remain in effect. RO participants will have the ability to earn back a portion of the quality and patient experience withholds based on their reporting of clinical data, their reporting and performance on quality measures, and as of PY3, performance on the beneficiary-reported Consumer Assessment of Healthcare Providers and Systems (CAHPS(R))
(e) RO Model Quality Measures and Reporting Requirements
We are adopting four quality measures and will collect the CAHPS(R) Cancer Care Radiation Therapy Survey for the RO Model. Three of the four measures are
RO participants will be paid for reporting clinical data in accordance with our reporting requirements (as discussed in section III.C.8.e. of this final rule), and paid for performance on aggregated quality measure data on three quality measures and pay-for-reporting on one quality measure (for PY1 and PY2) (as discussed in section III.C.8.f. of this final rule). We are adding a set of patient experience measures based on the CAHPS(R) Cancer Care Survey for Radiation Therapy for inclusion as pay-for-performance measures. We will also require Professional participants and Dual participants to report all quality data for all applicable patients receiving RT services from RO participants based on numerator and denominator specifications for each measure (for example, not just Medicare beneficiaries or beneficiaries receiving care for RO episodes).
(f) RO Model Data Sharing Process
We will collect quality and clinical data for the RO Model. We intend to share certain data with RO participants to the extent permitted by the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule and other applicable law. We are establishing data privacy compliance standards for RO participants. We are establishing requirements around the public release of patient de-identified information by RO participants. We will offer RO participants the opportunity to request a claims data file that contains patient-identifiable data on the RO participant's patient population for clinical treatment, care management and coordination, and quality improvement activities. Also, we will permit the data to be reused by RO participants for provider incentive design and implementation, and we believe it may be of use in RO participants' review of our calculation of their participant-specific episode payment amounts and reconciliation payment amounts or repayment amounts, as applicable. Thus, we expect that the data offered under the RO Model will be used by RO participants and CMS to better understand Model effects, establish benchmarks, and monitor participant compliance. Again, as previously described, the data uses and sharing will be allowed only to the extent permitted by the HIPAA Privacy Rule and other applicable law.
When using or disclosing such data, the RO participant will be required to make "reasonable efforts to limit" the information to the "minimum necessary" as defined by 45 CFR 164.502(b) and 164.514(d) to accomplish the intended purpose of the use, disclosure, or request. The RO participant will be required to further limit its disclosure of such information to what is permitted by applicable law, including the regulations promulgated under the HIPAA and the Health Information Technology for
(g) RO Model Beneficiary Protections
We are requiring Professional participants and Dual participants to notify RO beneficiaries of the beneficiary's inclusion in this Model through a standardized written notice to each RO beneficiary during the treatment planning service. We intend to provide a notification template, which RO participants may personalize with contact information and logos, but must otherwise not be changed. Further explanation of the beneficiary notification can be found in section III.C.15. of this final rule.
(h) RO Model Program Policy Waivers
We believe it will be necessary to waive certain requirements of title XVIII of the Act solely for purposes of carrying out the testing of the RO Model under section 1115A(b) of the Act. We will issue these waivers using our waiver authority under section 1115A(d)(1) of the Act. Each of the waivers is discussed in detail in section III.C.10. of this final rule, and codified in our regulations at Section 512.280.
c. ESRD Treatment Choices (ETC) Model
The ETC Model will be a mandatory payment model, focused on encouraging greater use of home dialysis and kidney transplants for ESRD Beneficiaries among ESRD facilities and Managing Clinicians located in Selected Geographic Areas. The ETC Model will include two payment adjustments. The first payment adjustment, the Home Dialysis Payment Adjustment (HDPA), will be a positive adjustment on certain home dialysis and home dialysis-related claims during the initial 3 years of the model. The second payment adjustment, the Performance Payment Adjustment (PPA), will be a positive or negative adjustment on dialysis and dialysis-related Medicare payments, for both home dialysis and in-center dialysis, based on ESRD facilities' and Managing Clinicians' rates of home dialysis, and of kidney transplant waitlisting and living donor transplantation, among attributed beneficiaries during the applicable MY. We are implementing the payment adjustments under the ETC Model beginning
(1) Summary of the ETC Model Provisions
(a) ETC Model Overview
Beneficiaries with ESRD generally require some form of renal replacement therapy, the most common being hemodialysis (HD), followed by peritoneal dialysis (PD), or a kidney transplant. Most beneficiaries with ESRD receive HD treatments in an ESRD facility; however, other renal replacement modalities--including dialyzing at home or receiving a kidney transplant--may be better options than in-center dialysis for more beneficiaries than currently use them. We are finalizing the ETC Model to test the effectiveness of adjusting certain Medicare payments to ESRD facilities and Managing Clinicians--clinicians who furnish and bill the Monthly Capitation Payment (MCP) for managing ESRD Beneficiaries--to encourage greater utilization of home dialysis and kidney transplantation, support beneficiary modality choice, reduce Medicare expenditures, and preserve or enhance the quality of care. We believe ESRD facilities and Managing Clinicians are the key providers and suppliers managing the dialysis care and treatment modality options for ESRD Beneficiaries and have a vital role to play in beneficiary modality selection and assisting beneficiaries through the transplant process. We are adjusting payments for home dialysis and home dialysis-related claims with claim service dates from
(b) ETC Model Scope
The ETC Model will be a mandatory payment model focused on encouraging greater use of home dialysis and kidney transplants for ESRD Beneficiaries. The rationale for a mandatory model for ESRD facilities and Managing Clinicians within Selected Geographic Areas is that we seek to test the effect of payment incentives on availability and choice of treatment modality among a diverse group of providers and suppliers. We will randomly select Hospital Referral Regions (HRRs) for inclusion in the Model, and also include all HRRs with at least 20 percent of ZIP Codes located in
(c) Home Dialysis Payment Adjustment (HDPA)
We will make upward adjustments to certain payments made to participating ESRD facilities under the ESRD Prospective Payment System (PPS) on home dialysis claims, and will make upward adjustments to the MCP paid to participating Managing Clinicians on home dialysis-related claims. The HDPA will apply to claims with claim service dates beginning on
(d) Home Dialysis and Transplant Performance Assessment and Performance Payment Adjustment (PPA)
We will assess ETC Participants' rates of home dialysis, and transplant waitlisting and living donor transplantation, during a MY, which will include 12 months of performance data. Each MY will overlap with the previous MY, if any, and the subsequent MY, if any, for a period of 6 months. Each MY will have a corresponding PPA Period--a 6-month period, which will begin 6 months after the conclusion of the MY. We will adjust certain payments for ETC Participants during the PPA Period based on the ETC Participant's home dialysis rate and transplant rate, calculated as the sum of the transplant waitlist rate and the living donor transplant rate, during the corresponding MY. We will be measuring rates of home dialysis, and of transplant waitlisting and living donor transplantation, for ESRD facilities and Managing Clinicians using Medicare claims data, Medicare administrative data including enrollment data, and the Scientific Registry of Transplant Recipients (SRTR) data. We will measure home dialysis rates for ESRD facilities and Managing Clinicians in the ETC Model by calculating the number of dialysis treatment beneficiary years during the MY in which attributed beneficiaries received dialysis at home, plus one half the total number of dialysis treatment beneficiary years during the MY in which attributed beneficiaries received self dialysis in center. We will measure transplant rates for ESRD facilities and Managing Clinicians by calculating the number of attributed beneficiary years during the MY for which attributed beneficiaries were on the kidney transplant waitlist and by calculating the number of attributed beneficiary years during the MY for which attributed beneficiaries received living donor transplants. The ETC Model will make upward and downward adjustments to certain payments to participating ESRD facilities under the ESRD PPS and to the MCP paid to participating Managing Clinicians based upon the ETC Participant's home dialysis rate and transplant rate. The magnitude of the positive and negative PPAs for ETC Participants will increase over the course of the Model. These PPAs will apply to claims with claim service dates beginning
(e) ETC Model Overlaps With Other Innovation Center Models and CMS Programs
The ETC Model will overlap with several other CMS programs and models, including initiatives specifically focusing on dialysis care. We believe the ETC Model will be compatible with other dialysis-focused CMS programs and models. However, we will work to resolve any potential overlaps between the ETC Model and other CMS models or programs that could result in repetitive services or duplicative payment for services. The payment adjustments made under the ETC Model will be counted as expenditures under the Medicare Shared Savings Program and other shared savings initiatives. Additionally, ESRD facilities will remain subject to the quality requirements in ESRD Quality Incentive Program (QIP), and Managing Clinicians who are MIPS eligible clinicians will remain subject to MIPS unless otherwise excluded.
(f) ETC Model Medicare Payment Waivers
In order to make the proposed payment adjustments under the ETC Model, namely the HDPA and PPA, we will need to waive certain Medicare program requirements. In particular, we will waive certain requirements of the Act for the ESRD PPS, ESRD QIP, and Medicare Physician Fee Schedule only to the extent necessary to make the payment adjustments under the ETC Model for ETC Participants. In addition, we will waive certain requirements such that the payment adjustments made under the ETC Model will not change beneficiary cost-sharing from the regular Medicare program cost-sharing for the related Part B services that were paid for beneficiaries who receive services from ETC Participants.
It will also be necessary to waive certain Medicare payment requirements of section 1861(ggg) of the Act and implementing regulations at 42 CFR 410.48, regarding the use of the Kidney Disease Education (KDE) benefit, solely for the purposes of testing the ETC Model. The purpose of such waivers will be to give ETC Participants additional access to the tools necessary to ensure beneficiaries select their preferred kidney replacement modality. As education is a key component of assisting beneficiaries with making such selections, we will waive select requirements regarding the provision of the KDE benefit, including waiving the requirement that certain health care provider types must furnish the KDE service to allow additional staff to furnish the service, waiving the requirement that the KDE service be furnished to beneficiaries with Stage IV CKD to allow ETC Participants to furnish these services to beneficiaries in later stages of kidney disease, and waiving certain restrictions on the KDE curriculum to allow the content to be tailored to each beneficiary's needs.
We will issue these waivers using our waiver authority under section 1115A(d)(1) of the Act.
(g) ETC Model Monitoring and Quality Measures
Consistent with the monitoring requirements in the general provisions, we will closely monitor the implementation and outcomes of the ETC Model throughout its duration. The purpose of this monitoring will be to ensure that the ETC Model is implemented safely and appropriately, the quality or experience of care for beneficiaries is not harmed, and adequate patient and program integrity safeguards are in place.
As part of the monitoring strategy, we will be using two quality measures for the ETC Model: The Standardized Mortality Ratio and the Standardized Hospitalization Ratio. These measures are NQF-endorsed, and are currently calculated at the ESRD facility level for Dialysis Facility Reports and the ESRD QIP, respectively. Therefore, we will require no additional reporting of quality measures by ETC Participants. We intend to propose a beneficiary experience measure in future rulemaking.
(h) ETC Model Beneficiary Protections
The ETC Model will not allow beneficiaries to opt out of the payment adjustments for their ESRD facility or Managing Clinician; however, the Model will not restrict a beneficiary's freedom to choose an ESRD facility or Managing Clinician, or any other provider or supplier, and ETC Participants will be subject to the general provisions protecting beneficiary freedom of choice and access to medically necessary covered services. We also will require that ETC Participants notify beneficiaries of the ETC Participant's participation in the ETC Model by prominently displaying informational materials in ESRD facilities and Managing Clinician offices or facilities where beneficiaries receive care. Additionally, ETC Participants will be subject to the general provisions regarding descriptive model materials and activities.
B. Background
In the
As we stated in the proposed rule, we believe that these two models will test ways to further our goals of reducing Medicare expenditures while preserving or enhancing the quality of care furnished to beneficiaries.
We received approximately 330 timely pieces of correspondence in response to our solicitation of public comments on the proposed rule. While we are finalizing several of the provisions from the proposed rule, there are a number of provisions from the proposed rule that we intend to address later and a few that we do not intend to finalize. We also note that some of the public comments were outside of the scope of the proposed rule. These out-of-scope public comments are not addressed in this final rule. Summaries of the public comments that are within the scope of the proposed rule and our responses to those public comments are set forth in the various sections of this final rule under the appropriate heading. However, we note that in this final rule we are not addressing most comments received with respect to the provisions of the proposed rule that we are not finalizing at this time. Rather, we will address them at a later time, in a subsequent rulemaking document, as appropriate.
Administrator,
Dated:
Alex M. Azar II,
Secretary,
BILLING CODE 4120-01-P
BILLING CODE 4120-01-C
[FR Doc. 2020-20907 Filed 9-21-20;
BILLING CODE 4120-01-P
The document is published in the
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