Medicare Program; Specialty Care Models To Improve Quality of Care and Reduce Expenditures

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Part 512

[CMS-5527-P]

RIN 0938-AT89

Medicare Program; Specialty Care Models To Improve Quality of Care and Reduce Expenditures

AGENCY:

Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION:

Proposed rule.

SUMMARY:

This proposed rule proposes to implement 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 proposed RO Model would promote quality and financial accountability for providers and suppliers of radiotherapy (RT). The RO Model would 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 proposed ETC Model would 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 would include ESRD facilities and certain clinicians caring for beneficiaries with ESRD—or Managing Clinicians—located in selected geographic areas as participants. CMS would assess the performance of participating Managing Clinicians and ESRD facilities on their rates of home dialysis and kidney and kidney-pancreas transplants during each Measurement Year (MY), and would subsequently adjust certain of their Medicare payments upward or downward during the corresponding performance payment adjustment period based on their home dialysis rate and transplant rate. CMS would also positively adjust certain Medicare payments to participating ESRD facilities and Managing Clinicians for home dialysis and home dialysis-related claims in the initial 3 years of the ETC Model.

We believe that these two proposed models would test ways to further our goals of reducing Medicare expenditures while preserving or enhancing the quality of care furnished to beneficiaries.

DATES:

Comment period:

To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. Eastern Standard Time on September 16, 2019.

ADDRESSES:

In commenting, please refer to file code CMS-5527-P. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission.

Comments, including mass comment submissions, must be submitted in one of the following three ways (please choose only one of the ways listed):

1. Electronically. You may submit electronic comments on this regulation to

http://www.regulations.gov.

Follow the “Submit a comment” instructions.

2. By regular mail. You may mail written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-5527-P, P.O. Box 8013, Baltimore, MD 21244-1850.

Please allow sufficient time for mailed comments to be received before the close of the comment period.

3. By express or overnight mail. You may send written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-5527-P, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-8013.

For information on viewing public comments, see the beginning of the

SUPPLEMENTARY INFORMATION

section.

FOR FURTHER INFORMATION CONTACT:

Rebecca Cole (410) 786-1589.

Megan.Hyde@cms.hhs.gov,

for questions related to General Provisions.

RadiationTherapy@cms.hhs.gov,

for questions related to the Radiation Oncology Model.

ETC-CMMI@cms.hhs.gov,

for questions related to the ESRD Treatment Choices Model.

SUPPLEMENTARY INFORMATION:

Inspection of Public Comments:

All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following website as soon as possible after they have been received:

http://www.regulations.gov.

Follow the search instructions on that website to view public comments.

Electronic Access

This

Federal Register

document is also available from the

Federal Register

online database through Federal Digital System (FDsys), a service of the U.S. Government Publishing Office. This database can be accessed via the internet at

http://www.gpo.gov/fdsys/.

Current Procedural Terminology (CPT) Copyright Notice

Throughout this proposed rule, we use CPT® codes and descriptions to refer to a variety of services. We note that CPT® codes and descriptions are copyright 2019 American Medical Association. All Rights Reserved. CPT® is a registered trademark of the American Medical Association (AMA). Applicable Federal Acquisition Regulations (FAR) and Defense Federal Acquisition Regulations (DFAR) apply.

I. Executive Summary

A. Purpose

The purpose of this proposed rule is to propose the implementation and testing of two new mandatory models under the authority of the Innovation Center, as well as to propose certain general provisions that would be applicable to both the RO Model and the ETC Model. Section 1115A of the Social Security Act (the Act) authorizes the Innovation Center to test innovative payment and service delivery models expected to reduce Medicare, Medicaid, and Children's Health Insurance Program (CHIP) expenditures while preserving or enhancing the quality of care furnished to the beneficiaries of such programs. Under the Medicare fee-for-service (FFS) program, Medicare generally makes a separate payment to providers and suppliers for each item or service furnished to a beneficiary during the course of treatment. Because the amount of payments received by a provider or supplier for such items and services varies with the volume of items and services furnished to a beneficiary, some providers and suppliers may be financially incentivized to inappropriately increase the volume of items and services to receive higher payments. Medicare FFS may also detract from a provider's or supplier's incentive to invest in quality improvement and care coordination activities if it means those activities will result in a lower volume of items and

services. As a result, care may be fragmented, unnecessary, or duplicative.

The goal for the proposed models is to preserve or enhance the quality of care furnished to beneficiaries while reducing program spending through enhanced financial accountability for model participants. We propose that the performance period of the proposed RO Model would begin in 2020, and end December 31, 2024. We propose to implement the proposed payment adjustments under the proposed ETC Model over the course of 6 and a half years, beginning January 1, 2020, and ending June 30, 2026.

The proposed models would 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 proposed models because, as discussed in depth in sections III and IV of this proposed rule, we believe that participants in these models would have significant opportunity to redesign care and improve the quality of care furnished to beneficiaries receiving these services.

We believe the proposed models would 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 proposed RO and ETC Models would require the participation of providers and suppliers that might not otherwise participate in these models, and would be tested in multiple geographic areas.

The proposed models would 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. We believe that participation in the proposed models by a large number of providers and suppliers with diverse characteristics would result in a robust data set for evaluating the models' proposed payment approaches and would stimulate the rapid development of new evidence-based knowledge. Testing the proposed models in this manner would 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 seek public comment on the proposals contained in this proposed rule, and also on any alternatives considered.

B. Summary of the Major Proposed Provisions

1. General Provisions

The proposed general provisions would be applicable only to participants in the RO Model and the ETC Model. We have identified the proposed general provisions based on standardized parameters that have been repeatedly memorialized in various documents governing participation in existing model tests and propose to make them applicable to both proposed models so that we may eliminate repetition in the proposed 42 CFR part 512. The proposed general provisions address beneficiary protections, model evaluation and monitoring, audits and record retention, monitoring and compliance, remedial or administrative 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 would apply to each model. Both the RO Model and the ETC Model have unique aspects that would require additional, more tailored provisions, including with respect to payment and quality measurement. Such model-specific provisions are described elsewhere in this proposed rule.

2. Model Overview—Proposed Radiation Oncology Model

In this proposed rule, we propose the creation and testing of a new payment model for radiation oncology, the RO Model. The intent of the proposed RO Model is to promote quality and financial accountability for episodes of care centered on RT services. The RO Model would test whether prospective episode-based payments to physician group practices (PGPs), HOPDs, and freestanding radiation therapy centers for RT episodes of care would reduce Medicare expenditures while preserving or enhancing the quality of care for Medicare beneficiaries. We anticipate the proposed RO Model would benefit Medicare beneficiaries by encouraging more efficient care delivery and incentivizing higher value care across episodes of care. We propose that the RO Model would have a performance period of five calendar years, beginning in 2020, and ending December 31, 2024. We propose to test the RO Model to capture all episodes that finish within the performance period, which means that the data collection, episode payments, and reconciliation would continue into calendar year 2025.

a. Summary of Major Provisions

(1) Proposed RO Model Overview

RT is a common treatment for patients undergoing cancer treatment and is typically furnished by a physician at either a HOPD or a freestanding radiation therapy center. We are proposing the RO Model to include prospective payments for certain RT services furnished during a 90-day episode for included cancer types for certain Medicare beneficiaries. The included cancer types would 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 proposed rule for more information.) This model would not account for total cost of all care provided to the beneficiary during the 90 days of an episode. Rather, the payment would cover only select RT services furnished during an episode. Episode payments would 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 providers and 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 would have at least one PGP to furnish RT services at the HOPD. A PGP would furnish the PC as a professional participant and a HOPD would furnish the TC as a technical participant. Both would be participants in the RO Model, furnishing separate components of the same episode. A 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 proposed RO Model would test the

cost-saving potential of prospective episode payments for certain RT services furnished during a 90-day episode and whether shorter courses of RT (that is, fewer doses, also known as fractions) would encourage more efficient care delivery and incentivize higher value care.

(2) Model Scope

We propose criteria for the types of cancer included under the RO Model and list 17 cancer types that meet our proposed 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 Model episodes would include most RT services furnished in HOPDs and freestanding radiation therapy centers during a 90-day episode.

We propose that participation in the RO Model be mandatory for all RT providers and suppliers within selected geographic areas. We propose to use Core Based Statistical Areas (CBSAs) delineated by the Office of Management and Budget

1

as the geographic area for the randomized selection of RO participants. We would link RT providers and RT suppliers to a CBSA by using the five digit ZIP Code of the location where RT services are furnished permitting us to identify RO Model participants while still using CBSA as a geographic unit of selection. In addition, we propose to exclude certain providers and suppliers from participation under the model as described in section III.C.3.c. of this proposed rule.

1

See

https://www.census.gov/programs-surveys/metro-micro/about/omb-bulletins.html.

We propose to include beneficiaries that meet certain criteria under the RO Model. For example, the proposed criteria would 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 would be included in the RO Model's episodes of care.

(3) Overlap With Other CMS Programs and Models

We expect that there could be situations where a Medicare beneficiary included in an episode under the RO Model is also assigned, aligned, or attributed to another Innovation Center model or CMS program. Overlap could also occur among providers and 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 would 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.

(4) Episodes and Episode Pricing Methodology

We propose to set a separate payment amount for the PC and the TC of each of the cancer types included in the RO Model. The payment amounts would be determined based on proposed national base rates, trend factors, and adjustments for each participant's case-mix, historical experience, and geographic location. The payment amount would also be adjusted for withholds for incomplete episodes, quality, and starting in performance year (PY) 3 beneficiary experience. The standard beneficiary coinsurance amounts (typically 20 percent of the Medicare-approved amount for services) and sequestration would remain in effect. RO participants would 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®) Cancer Care Radiation Therapy Survey.

(5) Quality Measures and Reporting Requirements

We propose to adopt four quality measures and collect the CAHPS® Cancer Care Radiation Therapy Survey for the RO Model. Three of the four measures that we are proposing are National Quality Forum (NQF)-endorsed process measures that are clinically appropriate for RT and are approved for the Merit-based Incentive Payment System (MIPS).

2 3

We selected all proposed measures based on clinical appropriateness for RT services spanning a 90-day episode period. These measures would be applicable to the full range of proposed included cancer types and provide us the ability to accurately measure changes or improvements in the quality of RT services. Further, we believe that these measures would allow the RO Model to apply a pay-for-performance methodology that incorporates performance measurement with a focus on clinical care and beneficiary experience with the aim of identifying a reduction in expenditures with preserved or enhanced quality of care for beneficiaries.

2

NQF endorsement summaries:

http://www.qualityforum.org/News_And_Resources/Endorsement_Summaries/Endorsement_Summaries.aspx.

3

See the CY 2018 QPP final rule (82 FR 53568).

We propose that RO participants would be paid for reporting clinical data in accordance with our proposed reporting requirements as discussed in section III.C.8.e, and paid for performance on aggregated quality measure data on three proposed quality measures and pay-for-reporting on one proposed quality measure (for PY1 and PY2) as discussed in section III.C.8.f. By PY3, we plan to propose to add a set of patient experience measures via rulemaking based on the CAHPS® Cancer Care Survey for Radiation Therapy for inclusion as pay-for-performance measures. We would 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 RT episodes under the RO Model).

(6) Data Sharing Process

We propose to collect quality, clinical, and administrative data for the RO Model. We intend to share certain data with participants to the extent permitted by the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule and other applicable law. We propose to establish data privacy compliance standards for RO participants. We propose to establish requirements around the public release of patient de-identified information by RO participants. We propose to 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 propose to 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 recoupment amounts, as applicable. Thus, we expect that the data offered under the RO Model would 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 would 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 would 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 would 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 Economic and Clinical Health (HITECH) laws at 45 CFR part 160 and subparts A and E of part 164. Further discussion of data sharing can be found in section III.C.13 of this proposed rule.

(7) Beneficiary Protections

We propose to require 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 session. 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 proposed rule.

(8) Program Policy Waivers

We believe it would 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 propose to 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 proposed rule, and proposed to be codified in our regulations at § 512.280.

3. Model Overview—Proposed ESRD Treatment Choices (ETC) Model

The proposed ETC Model would 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 proposed ETC Model would include two payment adjustments. The first adjustment, the Home Dialysis Payment Adjustment (HDPA), would be a positive adjustment on certain home dialysis and home dialysis-related claims during the initial three years of the model. The second adjustment, the Performance Payment Adjustment (PPA), would 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 kidney and kidney-pancreas transplants and home dialysis among attributed beneficiaries during the applicable MY. We propose to implement the payment adjustments under the ETC Model beginning January 1, 2020, and ending June 30, 2026.

a. Summary of Major Provisions

(1) Proposed 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 propose the ETC Model to test the effectiveness of adjusting certain Medicare payments to ESRD facilities and Managing Clinicians—clinicians who 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 propose to adjust payments for home dialysis claims with claim through dates from January 1, 2020, through December 31, 2022 through the HDPA, and to assess the rates of home dialysis and kidney transplant among beneficiaries attributed to ETC Participants during the period beginning January 1, 2020, and ending June 30, 2025, with the PPA based on those rates applying to claims for dialysis and dialysis-related services with claim-through dates beginning January 1, 2021, and ending June 30, 2026.

(2) Model Scope

The proposed ETC Model would 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 would 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 Maryland in addition to those selected through randomization. Managing Clinicians and ESRD facilities located in these selected geographic areas would be required to participate in the ETC Model and would be assessed on their rates of kidney and kidney-pancreas transplant and home dialysis among their attributed beneficiaries during each MY; CMS would then adjust certain of their Medicare payments upwards or downwards during the corresponding performance payment adjustment period. Managing Clinicians and ESRD facilities located in the selected geographic areas would also receive a positive adjustment on their home dialysis claims for the first three years of the ETC Model.

(3) Home Dialysis Payment Adjustment (HDPA)

We propose that CMS would make upward adjustments to the certain payments to participating ESRD facilities under the ESRD Prospective Payment System (PPS) on home dialysis claims, and would make upward adjustments to the MCP paid to participating Managing Clinicians on home dialysis claims. The HDPA would apply to claims with claims through dates beginning on January 1, 2020, and ending on December 31, 2022.

(4) Home Dialysis and Transplant Performance Assessment and Performance Payment Adjustment (PPA)

We propose to assess ETC Participants' rates of home dialysis and kidney and kidney-pancreas transplants during a MY, which would include 12 months of performance data. Each MY would overlap with the previous MY, if any, and the subsequent MY, if any, for a period of 6 months. Each MY would have a corresponding PPA Period—a 6-

month period, which would begin 6 months after the conclusion of the MY. CMS would adjust certain payments for ETC Participants during the PPA Period based on the ETC Participant's home dialysis rate and transplant rate during the corresponding MY. We propose measuring rates of home dialysis and transplants 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 propose to measure home dialysis rates for ESRD facilities and Managing Clinicians in the ETC Model by calculating the percent of dialysis treatment beneficiary years during the MY in which attributed beneficiaries received dialysis at home. We propose to measure transplant rates for ESRD facilities and Managing Clinicians based on the number of attributed beneficiaries who received a kidney or kidney-pancreas transplant during the MY out of all attributed dialysis treatment beneficiary years (and attributed beneficiary years for pre-emptive transplant beneficiaries for Managing Clinicians) during the MY. For both Managing Clinicians and ESRD facilities, we propose to calculate the rates of home dialysis and kidney and kidney-pancreas transplants among attributed ESRD Beneficiaries. For Managing Clinicians, we propose to also include attributed beneficiaries who receive preemptive transplants—transplants that occur before the beneficiary begins dialysis—in the calculation of the transplant rate. We propose that the ETC Model would 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 rates of home dialysis and transplants. The magnitude of the positive and negative PPAs for ETC Participants would increase over the course of the Model. These PPAs would begin July 1, 2021, and end June 30, 2026.

(5) Overlaps With Other Innovation Center Models and CMS Programs

The ETC Model would overlap with several other CMS programs and models, including initiatives specifically focusing on dialysis care. We believe the ETC Model would be compatible with other dialysis-focused CMS programs and models. However, we would work to resolve any potential overlaps between the ETC Model and other Innovation Center models or CMS programs that could result in repetitive services or duplicative payment of services. The payment adjustments made under the ETC Model would be counted as expenditures under the Medicare Shared Savings Program and other shared savings initiatives. Additionally, ESRD facilities would remain subject to the quality requirements in ESRD Quality Incentive Program (QIP), and Managing Clinicians who are MIPS eligible clinicians would remain subject to MIPS.

(6) Medicare Payment Waivers

In order to make the proposed payment adjustments under the ETC Model, namely the HDPA and PPA, we believe we would need to waive certain Medicare program rules. In particular, we would waive certain requirements of the Act for the ESRD PPS, ESRD QIP, and Medicare Physician Fee Schedule only to the extent necessary to make these payment adjustments under this proposed payment model for ETC Participants selected in accordance with CMS's proposed selection methodology. In addition, we propose that the payment adjustments made under the ETC Model, if finalized, would 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.

We also believe it would be necessary to waive certain Medicare payment requirements of 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 would 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 propose to 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 benefit to be tailored to each beneficiary's needs.

We propose to issue these waivers using our waiver authority under section 1115A(d)(1) of the Act.

(7) Monitoring and Quality Measures

Consistent with the monitoring requirements proposed in the general provisions, we propose to closely monitor the implementation and outcomes of the ETC Model throughout its duration. The purpose of this monitoring would 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 propose 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, and so would require no additional reporting by ETC Participants.

(8) Beneficiary Protections

As proposed, the ETC Model would not allow beneficiaries to opt out of the payment methodology; however, the model would not restrict a beneficiary's freedom to choose an ESRD facility or Managing Clinician, or any other provider or supplier, and ETC Participants would be subject to the general provisions protecting beneficiary freedom of choice and access to medically necessary services. We also would 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 would be subject to the general provisions regarding descriptive model materials and activities.

II. General Provisions

A. Introduction

Section 1115A of the Act authorizes the Innovation Center to test innovative payment and service delivery models expected to reduce Medicare, Medicaid, and CHIP expenditures while preserving or enhancing the quality of care furnished to such programs' beneficiaries. The Innovation Center has designed and tested numerous models governed by participation agreements, cooperative agreements, model-specific addenda to existing contracts with CMS, and regulations. While each of these models have a specific payment methodology, quality metrics, and certain other applicable policies, they also have general provisions that are

very similar, including provisions on monitoring and evaluation; compliance with model requirements and applicable laws; and beneficiary protections. We believe it would promote efficiency to propose and seek comment on certain general provisions in each of these areas that would apply to both the RO Model and the ETC Model in this section II of the proposed rule. This would avoid the need to restate the same provisions separately for the two models in this proposed rule. We propose to codify these general provisions in a new subpart of the Code of Federal Regulations (42 CFR part 512, subpart A).

B. Effective Date and Scope

In § 512.100(a), we propose that the proposed general provisions in this section II of the proposed rule would apply only to the RO Model and the ETC Model, each of which we are proposing to refer to as an “Innovation Center model” for purposes of this section II. of the proposed rule. These proposed general provisions would not, except as specifically noted in proposed new part 512, affect the applicability of other provisions affecting providers and suppliers under Medicare FFS, including the applicability of provisions regarding payment, coverage, and program integrity (such as those in parts 413, 414, 419, 420, and 489 of chapter IV of 42 CFR and those in parts 1001-1003 of chapter V of 42 CFR).

In § 512.100(b), we propose that the proposed general provisions in this section II of the proposed rule would be applicable to model participants in both the RO Model (with one exception, described in this document) and the ETC Model. We are proposing to define the term “model participant” to mean an individual or entity that is identified as a participant in an Innovation Center model under the terms of proposed part 512; the term “model participant” as defined in this section II of the proposed rule includes, unless otherwise specified, the terms “RO Model participant” or “ETC Participant” as those terms are defined in proposed subparts B and C of proposed part 512. We propose to define “downstream participant” to mean an individual or entity that has entered into a written arrangement with a model participant pursuant to which the downstream participant engages in one or more Innovation Center model activities. A downstream participant may include, but would not be limited to, an individual practitioner, as defined for purposes of the RO Model. We propose to define “Innovation Center model activities” to mean any activities impacting the care of model beneficiaries related to the test of the Innovation Center model performed under the terms of proposed part 512. While not used in the general provisions described in this section II of the proposed rule, as this term is used for purposes of both the RO Model and the ETC Model, we propose to define “U.S. Territories” to mean American Samoa, the Federated States of Micronesia, Guam, the Marshall Islands, the Commonwealth of the Northern Mariana Islands, Palau, Puerto Rico, U.S. Minor Outlying Islands, and the U.S. Virgin Islands.

We invite public comment on the proposed general provisions discussed in this section II of the proposed rule.

C. Definitions

We propose at § 512.110 to define certain terms relevant to the general provisions proposed in this section II. of the proposed rule. We describe these proposed definitions in context throughout this section II. of the proposed rule.

D. Beneficiary Protections

As we design and test new models at the Innovation Center, we believe it is necessary to have certain protections in place to ensure that beneficiaries retain their existing rights and are not harmed by the participation of their health care providers in Innovation Center models. Therefore, we believe it is necessary to propose certain provisions regarding beneficiary choice, the availability of services, and descriptive model materials and activities.

For purposes of the general provisions, we are proposing to define the term “beneficiary” to mean an individual who is enrolled in Medicare FFS. This definition aligns with the proposed scope of the RO Model and the ETC Model, in which we propose to include only Medicare FFS beneficiaries. We also are proposing to define the term “model beneficiary” to mean a beneficiary attributed to a model participant or otherwise included in an Innovation Center model under the terms of this proposed part; the term “model beneficiary” as defined in this section would include, unless otherwise specified, the term “RO Beneficiary” and beneficiaries attributed to ETC participants under § 512.360. We believe it is necessary to propose this definition of model beneficiary so as to differentiate between Medicare FFS beneficiaries generally and those specifically included in an Innovation Center model.

1. Beneficiary Freedom of Choice

A beneficiary's ability to choose his or her provider or supplier is an important principle of Medicare FFS and is codified in section 1802(a) of the Act. To help ensure that this protection is not undermined by the testing of the two proposed Innovation Center models, we are proposing to codify at § 512.120(a)(1) a requirement that model participants and their downstream participants not restrict a beneficiary's ability to choose his or her providers or suppliers. The proposed policy would apply with respect to all Medicare FFS beneficiaries, not just model beneficiaries, because we believe it is important to ensure that the proposed Innovation Center model tests do not interfere with the general guarantees and protections for all Medicare FFS beneficiaries.

Also, we propose to codify at § 512.120(a)(2) that the model participant and its downstream participants must not commit any act or omission, nor adopt any policy that inhibits beneficiaries from exercising their freedom to choose to receive care from any Medicare-participating provider or supplier, or from any health care provider who has opted out of Medicare. We believe this requirement is necessary to ensure Innovation Center models do not prevent beneficiaries from the general rights and guarantees provided under Medicare FFS. However, because we believe that it is important for model participants to have the opportunity to explain the benefits of care provided by them to model beneficiaries, we also are proposing that the model participant and its downstream participants would be permitted to communicate to model beneficiaries the benefits of receiving care with the model participant, if otherwise consistent with the requirements of proposed part 512 and applicable law.

We propose at § 512.110 to define the terms “provider” and “supplier,” as used in proposed part 512, in a manner consistent with how these terms are used in Medicare FFS generally. Specifically, we would define the term “provider” to mean a “provider of services” as defined under section 1861(u) of the Act and codified in the definition of “provider” at 42 CFR 400.202. We similarly propose to define the term “supplier” to mean a “supplier” as defined in section 1861(d) of the Act and codified at 42 CFR 400.202. We believe it is necessary to define “provider” and “supplier” in this way as a means of noting to the general public that we are using the generally

applicable Medicare definitions of these terms for purposes of proposed part 512.

2. Availability of Services

Models tested under the authority of section 1115A of the Act are designed to test potential improvements to the delivery of and payment for health care to reduce Medicare, Medicaid, and CHIP expenditures while preserving or enhancing the quality of care for the beneficiaries of these programs. As such, an important aspect of testing Innovation Center models is that beneficiaries continue to access and receive needed care. Therefore, we are proposing in § 512.120(b)(1) that model participants and downstream participants would be required to continue to make medically necessary covered services available to beneficiaries to the extent required by law. Consistent with the limitation on Medicare coverage under section 1862(a)(1)(A) of the Act, we propose to define “medically necessary” to mean reasonable and necessary for the diagnosis or treatment of an illness or injury, or to improve the functioning of a malformed body member. Also, we propose to define “covered services” to mean the scope of health care benefits described in sections 1812 and 1832 of the Act for which payment is available under Part A or Part B of Title XVIII of the Act, which aligns with Medicare coverage standards and the definition of “covered services” used in other models tested by the Innovation Center. Also, we propose that model beneficiaries and their assignees, as defined in 42 CFR 405.902, would retain their rights to appeal Medicare claims in accordance with 42 CFR part 405, subpart I. We believe that model beneficiaries and their assignees should not lose the right to appeal claims for Medicare items and services furnished to them solely because the beneficiary's provider or supplier is participating in an Innovation Center model.

Also, we are proposing in § 512.120(b)(2) to prohibit model participants and downstream participants from taking any action to avoid treating beneficiaries based on their income levels or based on factors that would render a beneficiary an “at-risk beneficiary” as that term is defined for purposes of the Medicare Shared Savings Program at 42 CFR 425.20, a practice commonly referred to as “lemon dropping.” For example, 42 CFR 425.20 defines an “at-risk beneficiary” to include, without limitation, a beneficiary who has one or more chronic conditions or who is entitled to Medicaid because of disability. As such, a model participant or downstream participant would be prohibited from taking action to avoid treating beneficiaries with chronic conditions such as obesity or diabetes, or who are entitled to Medicaid because of disability. We believe it is necessary to specify prohibitions on avoiding treating at-risk beneficiaries, including those with obesity or diabetes, or who are eligible for Medicaid because of disability, to prevent potential lemon dropping of beneficiaries. Further, we believe this proposal prohibiting lemon dropping is a necessary precaution to counter any incentives created by the proposed Innovation Center models for model participants to avoid treating potentially high-cost beneficiaries who are most in need of quality care. This prohibition has been incorporated into the governing documentation of many current models being tested by the Innovation Center for this same reason. Also, we are proposing in § 512.120(b)(3) an additional provision that would prohibit model participants from taking any action to selectively target or engage beneficiaries who are relatively healthy or otherwise expected to improve the model participant's or downstream participant's financial or quality performance, a practice commonly referred to as “cherry-picking.” For example, a model participant or downstream participant would be prohibited from targeting only healthy, well educated, or wealthy beneficiaries for voluntary alignment, the receipt of permitted beneficiary incentives or other interventions, or the reporting of quality measures. Further, we are seeking comments on whether prohibiting cherry-picking will prevent model participants from artificially inflating their financial or quality performance results.

3. Descriptive Model Materials and Activities

In order to protect beneficiaries from potentially being misled about Innovation Center models, we are proposing at § 512.120(c)(1) to prohibit model participants and their downstream participants, from using or distributing descriptive model materials and activities that are materially inaccurate or misleading. For purposes of proposed part 512, we propose to define the term “descriptive model materials and activities” to mean general audience materials such as brochures, advertisements, outreach events, letters to beneficiaries, web pages, mailings, social media, or other materials or activities distributed or conducted by or on behalf of the model participant or its downstream participants when used to educate, notify, or contact beneficiaries regarding the Innovation Center model. We are further proposing that the following communications would not be descriptive model materials and activities: Communications that do not directly or indirectly reference the Innovation Center model (for example, information about care coordination generally); information on specific medical conditions; referrals for health care items and services; and any other materials that are excepted from the definition of “marketing” as that term is defined at 45 CFR 164.501. The potential for model participants to receive certain payments under the two proposed Innovation Center models may be an incentive for model participants and their downstream participants to engage in marketing behavior that may confuse or mislead beneficiaries about the Innovation Center model or their Medicare rights. Therefore, we believe it is necessary to ensure that those materials and activities that are used to educate, notify, or contact beneficiaries regarding the Innovation Center model are not materially inaccurate or misleading because these materials might be the only information that a model beneficiary receives regarding the beneficiary's inclusion in the model. Additionally, we understand that not all communications between the model participant or downstream participants and the model beneficiaries would address the model beneficiaries' care under the model. As such, we would note that this proposed prohibition in no way restricts the ability of a model participant or its downstream participants to engage in activism or otherwise alert model beneficiaries to the drawbacks of mandatory models in which they would otherwise decline to participate, provided that such statements are not materially inaccurate or misleading. Because regulating information or communication not related to the model does not advance CMS's interest in ensuring model beneficiaries are not misled about their inclusion in an Innovation Center model or their Medicare rights generally, we have proposed to define the term “descriptive model materials and activities” such that these materials are not subject to the requirements of proposed § 512.120(c)(1).

Also, we propose in § 512.120(c)(4) to reserve the right to review, or have our designee review, descriptive model materials and activities to determine whether the content is materially inaccurate or misleading; this review would not be a preclearance by CMS, but would take place at a time and in

a manner specified by CMS once the materials and activities are in use by the model participant. We believe it would be necessary for CMS to have this ability to review descriptive model materials and activities in order to protect model beneficiaries from receiving misleading or inaccurate materials regarding the Innovation Center model. Further, to facilitate our ability to conduct this review and to monitor Innovation Center models generally, in proposed § 512.120(c)(3) we are proposing to require model participants and downstream participants, to retain copies of all written and electronic descriptive model materials and activities and to retain appropriate records for all other descriptive model materials and activities in a manner consistent with § 512.135(c) (record retention).

Also, we are proposing in § 512.120(c)(2) to require model participants and downstream participants to include the following disclaimer on all descriptive model materials and activities: “The statements contained in this document are solely those of the authors and do not necessarily reflect the views or policies of the Centers for Medicare & Medicaid Services (CMS). The authors assume responsibility for the accuracy and completeness of the information contained in this document.” We are proposing to require the use of this disclaimer so that the public, and beneficiaries in particular, are not misled into believing that model participants or their downstream participants are speaking on behalf of the agency. We seek comment on whether we should propose a different disclaimer that alerts beneficiaries that we prohibit misleading information and give them contact information where a beneficiary could reach out to us if they suspect the information they have received regarding an Innovation Center model is inaccurate.

E. Cooperation With Model Evaluation and Monitoring

Section 1115A(b)(4) of the Act requires the Secretary to evaluate each model tested under the authority of section 1115A and to publicly report the evaluation results in a timely manner. The evaluation must include an analysis of the quality of care furnished under the model and the changes in program spending that occurred due to the model. Models tested by the Innovation Center are rigorously evaluated. For example, when evaluating models tested under section 1115A, we require the production of information that is representative of a wide and diverse group of model participants and includes data regarding potential unintended or undesirable effects, such as cost-shifting. The Secretary must take the evaluation into account if making any determinations regarding the expansion of a model under section 1115A(c) of the Act.

In addition to model evaluations, the Innovation Center regularly monitors model participants for compliance with model requirements. For the reasons described in section II.H of this proposed rule, these compliance monitoring activities are an important and necessary part of the model test.

Therefore, we are proposing to codify at § 512.130, that model participants and their downstream participants must comply with the requirements of 42 CFR 403.1110(b) (regarding the obligation of entities participating in the testing of a model under section 1115A of the Act to report information necessary to monitor and evaluate the model), and must otherwise cooperate with CMS' model evaluation and monitoring activities as may be necessary to enable CMS to evaluate the Innovation Center model in accordance with section 1115A(b)(4) of the Act. This participation in the evaluation may include, but is not limited to, responding to surveys and participating in focus groups. Additional details on the specific research questions that we propose that the Innovation Center model evaluation will consider for the Radiation Oncology Model and ESRD Treatment Choices Model can be found in sections III.C.16. and IV.C.11. of this proposed rule, respectively. Further, we propose to conduct monitoring activities according to proposed § 512.150, described later in this proposed rule, including producing such data as may be required by CMS to evaluate or monitor the Innovation Center model, which may include protected health information as defined in 45 CFR 160.103 and other individually identifiable data.

F. Audits and Record Retention

By virtue of their participation in an Innovation Center model, model participants and their downstream participants may receive model-specific payments, access to payment rule waivers, or some other model-specific flexibility. Therefore, we believe that CMS's ability to audit, inspect, investigate, and evaluate records and other materials related to participation in Innovation Center models is necessary and appropriate. In addition, we are proposing in § 512.110 to require model participants and their downstream participants to continue to make medically necessary covered services available to beneficiaries to the extent required by law. Similarly, in order to expand a phase 1 model tested by the Innovation Center, among other things, the Secretary must first determine that such expansion would not deny or limit the coverage or provision of benefits under the applicable title for applicable individuals. Thus, there is a particular need for CMS to be able to audit, inspect, investigate, and evaluate records and materials related to participation in Innovation Center models to allow us to ensure that model participants are in no way denying or limiting the coverage or provision of benefits for beneficiaries as part of their participation in the Innovation Center model. We propose to define “model-specific payment” to mean a payment made by CMS only to model participants, or a payment adjustment made only to payments made to model participants, under the terms of the Innovation Center model that is not applicable to any other providers or suppliers; the term “model-specific payment” would include, unless otherwise specified, the terms “home dialysis payment adjustment (HDPA),” “performance payment adjustment (PPA),” “participant-specific professional episode payment,” or “participant-specific technical episode payment.” We believe it is necessary to propose this definition in order to distinguish payments and payment adjustments applicable to model participants as part of their participation in an Innovation Center model, from payments and payment adjustments applicable to model participants as well as other providers and suppliers, as certain provisions of proposed part 512 would apply only to the former category of payments and payment adjustments.

We note that there are audit and record retention requirements under the Medicare Shared Savings Program (42 CFR 425.314) and in current models being tested under section 1115A (such as under 42 CFR 510.110 for the Innovation Center's Comprehensive Care for Joint Replacement Model). Building off those existing requirements, we propose in § 512.135(a), that the Federal Government, including, but not limited to, CMS, HHS, and the Comptroller General, or their designees, would have a right to audit, inspect, investigate, and evaluate any documents and other evidence regarding implementation of an Innovation Center model. Additionally, in order to align with the policy of current models being tested by

the Innovation Center, we are proposing in § 512.135(b) and (c) that the model participant and its downstream participants must:

• Maintain and give the Federal Government, including, but not limited to, CMS, HHS, and the Comptroller General, or their designees, access to all documents (including books, contracts, and records) and other evidence sufficient to enable the audit, evaluation, inspection, or investigation of the Innovation Center model, including, without limitation, documents and other evidence regarding all of the following:

++ Compliance by the model participant and its downstream participants with the terms of the Innovation Center model, including proposed new subpart A of proposed part 512.

++ The accuracy of model-specific payments made under the Innovation Center model.

++ The model participant's payment of amounts owed to CMS under the Innovation Center model.

++ Quality measure information and the quality of services performed under the terms of the Innovation Center model, including proposed new subpart A of proposed part 512.

++ Utilization of items and services furnished under the Innovation Center model.

++ The ability of the model participant to bear the risk of potential losses and to repay any losses to CMS, as applicable.

++ Patient safety.

++ Any other program integrity issues.

• Maintain the documents and other evidence for a period of 6 years from the last payment determination for the model participant under the Innovation Center model or from the date of completion of any audit, evaluation, inspection, or investigation, whichever is later, unless—

++ CMS determines there is a special need to retain a particular record or group of records for a longer period and notifies the model participant at least 30 days before the normal disposition date; or

++ There has been a termination, dispute, or allegation of fraud or similar fault against the model participant in which case the records must be maintained for an additional six (6) years from the date of any resulting final resolution of the termination, dispute, or allegation of fraud or similar fault.

If CMS notifies the model participant of a special need to retain a record or group of records at least 30 days before the normal disposition date, we propose that the records must be maintained for such period of time determined by CMS. We also propose that, if CMS notifies the model participant of a special need to retain records or there has been a termination, dispute, or allegation of fraud or similar fault against the model participant or its downstream participants, the model participant must notify its downstream participants of the need to retain records for the additional period specified by CMS. This provision will ensure that that the government has access to the records.

To avoid any confusion or disputes regarding the timelines outlined in this section II.G of the proposed rule, we propose to define the term “days” to mean calendar days.

We invite public comment on these proposed provisions regarding audits and record retention.

Historically, the Innovation Center has required participants in section 1115A models to retain records for at least 10 years, which is consistent with the outer limit of the statute of limitations for the Federal False Claims Act and is consistent with the Shared Savings Program's policy outlined at 42 CFR 425.314(b)(2). For this reason, we also solicit public comments on whether we should require model participants and downstream participants to maintain records for longer than 6 years.

G. Rights in Data and Intellectual Property

To enable CMS to evaluate the Innovation Center models as required by section 1115A(b)(4) of the Act and to monitor the Innovation Center models pursuant to proposed § 512.150, described later in this rule, we are proposing to allow CMS to use any data obtained in accordance with proposed § 512.130 and proposed § 512.135 to evaluate and monitor the proposed Innovation Center models. We further propose that, consistent with section 1115A(b)(4)(B) of the Act, that CMS would be allowed to disseminate quantitative and qualitative results and successful care management techniques, including factors associated with performance, to other providers and suppliers and to the public. We propose that the data to be disseminated would include, but would not be limited to, patient de-identified results of patient experience of care and quality of life surveys, as well as patient de-identified measure results calculated based upon claims, medical records, and other data sources.

In order to protect the intellectual property rights of model participants and downstream participants, we propose in § 512.140(b) to require model participants and their downstream participants to label data they believe is proprietary that they believe should be protected from disclosure under the Trade Secrets Act. We would note that this approach is already in use in other models currently being tested by the Innovation Center, including the Next Generation Accountable Care Organization Model. Any such assertions would be subject to review and confirmation prior to CMS's acting upon such assertion.

We further propose to protect such information from disclosure to the full extent permitted under applicable laws, including the Freedom of Information Act. Specifically, in proposed § 512.140(b), we propose to not release data that has been confirmed by CMS to be proprietary trade secret information and technology of the model participant or its downstream participants without the express written consent of the model participant or its downstream participant, unless such release is required by law.

H. Monitoring and Compliance

Given that model participants may receive model-specific payments, access to payment rule waivers, or some other model-specific flexibility while participating in an Innovation Center model, we believe that enhanced compliance review and monitoring of model participants is necessary and appropriate to ensure the integrity of the Innovation Center model. In addition, as part of the Innovation Center's assessment of the impact of new Innovation Center models, we have a special interest in ensuring that model tests do not interfere with ensuring the integrity of the Medicare program. Our interests include ensuring the integrity and sustainability of the Innovation Center model and the underlying Medicare program, from both a financial and policy perspective, as well as protecting the rights and interests of Medicare beneficiaries. For these reasons, as a part of the models currently being tested by the Innovation Center, CMS or its designee monitors model participants to assess compliance with model terms and with other applicable program laws and policies. We believe our monitoring efforts help ensure that model participants are furnishing medically necessary covered services and are not falsifying data, increasing program costs, or taking other actions that compromise the integrity of the model or are not in the best interests of the model, the Medicare program, or Medicare beneficiaries.

In proposed § 512.150(b), we propose to continue this standard practice of

conducting compliance monitoring activities to ensure compliance by the model participant and each of its downstream participants with the terms of the Innovation Center model, including the requirements of proposed subpart A of proposed part 512, including to understand model participants' use of model-specific payments and to promote the safety of beneficiaries and the integrity of the Innovation Center model. Such monitoring activities would include, but not be limited to: (1) Documentation requests sent to the model participant and its downstream participants, including surveys and questionnaires; (2) audits of claims data, quality measures, medical records, and other data from the model participant and its downstream participants; (3) interviews with members of the staff and leadership of the model participant and its downstream participants; (4) interviews with beneficiaries and their caregivers; (5) site visits to the model participant and its downstream participants, which would be performed in a manner consistent with proposed § 512.150(c), described later in this rule; (6) monitoring quality outcomes and registry data; and (7) tracking patient complaints and appeals. We believe these specific monitoring activities, which align with those currently used in other models being tested by the Innovation Center, are necessary in order to ensure compliance with the terms and conditions of the Innovation Center model, including proposed subpart A of proposed part 512, and to protect beneficiaries from potential harms that may result from the activities of a model participant or its downstream participants, such as attempts to reduce access to or the provision of medically necessary covered services.

We propose to codify in § 512.150(b)(2), that when we are conducting compliance monitoring and oversight activities, CMS or our designees would be authorized to use any relevant data or information, including without limitation Medicare claims submitted for items or services furnished to model beneficiaries. We believe that it is necessary to have all relevant information available to us during our compliance monitoring and oversight activities, including any information already available to us through the Medicare program.

We propose to require in § 512.150(c)(1) that model participants and their downstream participants cooperate in periodic site visits conducted by CMS or its designee in a manner consistent with proposed § 512.130, described previously. Such site visits would be conducted to facilitate the model evaluation performed pursuant to section 1115A(b)(4) of the Act and to monitor compliance with the Innovation Center model terms (including proposed subpart A of proposed part 512).

In order to operationalize this proposal, we further propose in § 512.150(c)(2) that CMS or its designee would provide the model participant or its downstream participant with no less than 15 days advance notice of a site visit, to the extent practicable. Furthermore, we propose that, to the extent practicable, CMS would attempt to accommodate a request that a site visit be conducted on a particular date, but that the model participant or downstream participant would be prohibited from requesting a date that was more than 60 days after the date of the initial site visit notice from CMS. We believe the 60 day period would reasonably accommodate model participant's and downstream participants' schedules while not interfering with the operation of the Innovation Center model. Further, we propose in § 512.150(c)(3) to require the model participant and their downstream participants to ensure that personnel with the appropriate responsibilities and knowledge pertaining to the purpose of the site visit be available during any and all site visits. We believe this proposal is necessary to ensure an effective site visit and prevent the need for unnecessary follow-up site visits.

Also, we are proposing in § 512.150(c)(4) that CMS or its designee could perform unannounced site visits to the offices of model participants and their downstream participants at any time to investigate concerns related to the health or safety of beneficiaries or other patients or other program integrity issues, notwithstanding these proposed provisions. Further, we propose in § 512.150(c)(5) that nothing in proposed part 512 would limit CMS from performing other site visits as allowed or required by applicable law. We believe that, regardless of the model being tested, CMS must always have the ability to timely investigate concerns related to the health or safety of beneficiaries or other patients, or program integrity issues, and to perform functions required or authorized by law. In particular, we believe that it is necessary for us to monitor, and for model participants and their downstream participants to be compliant with our monitoring efforts, to ensure that they are not denying or limiting the coverage or provision of medically necessary covered services to beneficiaries in an attempt to change model results or their model-specific payments, including discrimination in the provision of services to at-risk beneficiaries (for example, due to eligibility for Medicaid based on disability).

Model participants that are enrolled in Medicare will remain subject to all existing requirements and conditions for Medicare participation as set out in Federal statutes and regulations and provider and supplier agreements, unless waived under the authority of section 1115A(d)(1) of the Act solely for purposes of testing the Innovation Center model. Therefore, in § 512.150(a), we propose to require that model participants and each of their downstream participants must comply with all applicable laws and regulations. We note that a law or regulation is not “applicable” to the extent that its requirements have been waived pursuant to section 1115A(d)(1) of the Act solely for purposes of testing the Innovation Center model in which the model participant is participating.

To protect the financial integrity of each Innovation Center model, we propose in § 512.150(d) that if CMS discovers that it has made or received an incorrect model-specific payment under the terms of an Innovation Center model, CMS may make payment to, or demand payment from, the model participant. Also, we are considering the imposition of some of the deadlines set forth in the Medicare reopening rules at 42 CFR 405.980,

et seq.;

specifically we seek comment on whether CMS should be able to reopen an initial determination of a model-specific payment for any reason within 1 year of the model-specific payment, and within 4 years for good cause (as defined at 42 CFR 405.986). We believe this may be necessary to ensure we have a means and a timeline to make redeterminations on incorrect model-specific payments that we have made or received in conjunction with the proposed Innovation Center models.

We propose to codify at § 512.150(e) that nothing contained in the terms of the Innovation Center model or proposed part 512 would limit or restrict the authority of the HHS Office of Inspector General (OIG) or any other Federal Government authority, including its authority to audit, evaluate, investigate, or inspect the model participant or its downstream participants. This provision simply reflects the limits of CMS authority.

We invite public comment on these proposed provisions regarding monitoring of the proposed models and compliance by model participants.

I. Remedial Action

As stated earlier in this proposed rule, as part of the Innovation Center's monitoring and assessment of the impact of models tested under the authority of section 1115A, we have a special interest in ensuring that these model tests do not interfere with the program integrity interests of the Medicare program. For this reason, we monitor for compliance with model terms as well as other Medicare program rules. When we become aware of noncompliance with these requirements, it is necessary for CMS to have the ability to impose certain administrative remedial actions on a noncompliant model participant.

The terms of many models currently being tested by the Innovation Center permit CMS to impose one or more administrative remedial actions to address noncompliance by a model participant. We propose that CMS may impose any of the remedial actions set forth in proposed § 512.160(b) if we determine that the model participant or a downstream participant—

• Has failed to comply with any of the terms of the Innovation Center model, including proposed subpart A of proposed part 512, if finalized;

• Has failed to comply with any applicable Medicare program requirement, rule, or regulation;

• Has taken any action that threatens the health or safety of a beneficiary or other patient;

• Has submitted false data or made false representations, warranties, or certifications in connection with any aspect of the Innovation Center model;

• Has undergone a change in control (as defined in section II.L. of this proposed rule) that presents a program integrity risk;

• Is subject to any sanctions of an accrediting organization or a Federal, state, or local government agency;

• Is subject to investigation or action by HHS (including the HHS-OIG and CMS) or the Department of Justice due to an allegation of fraud or significant misconduct, including being subject to the filing of a complaint or filing of a criminal charge, being subject to an indictment, being named as a defendant in a False Claims Act qui tam matter in which the Federal Government has intervened, or similar action; or

• Has failed to demonstrate improved performance following any remedial action imposed by CMS.

In § 512.160(b), we propose to codify that CMS may take one or more of the following remedial actions if CMS determined that one or more of the grounds for remedial action described in proposed § 512.160(a) had taken place—

• Notify the model participant and, if appropriate, require the model participant to notify its downstream participants of the violation;

• Require the model participant to provide additional information to CMS or its designees;

• Subject the model participant to additional monitoring, auditing, or both;

• Prohibit the model participant from distributing model-specific payments;

• Require the model participant to remove, immediately or by a deadline specified by CMS, its agreement with a downstream participant with respect to the Innovation Center model;

• In the ETC Model only, terminate the ETC Participant from the ETC Model;

• Require the model participant to submit a corrective action plan in a form and manner and by a deadline specified by CMS;

• Discontinue the provision of data sharing and reports to the model participant;

• Recoup model-specific payments;

• Reduce or eliminate a model specific payment otherwise owed to the model participant, as applicable; or

• Such other action as may be permitted under the terms of proposed part 512.

We would note that because the ETC Model is a mandatory model, we would not expect to use the proposed provision that would allow CMS to terminate an ETC Participant's participation in the ETC Model, except in circumstances in which the ETC Participant has engaged, or is engaged in, egregious actions.

We invite public comment on these proposed provisions regarding the proposed grounds for remedial actions, remedial actions generally, and whether additional types of remedial action would be appropriate.

J. Innovation Center Model Termination by CMS

We are proposing certain provisions that would allow CMS to terminate an Innovation Center model under certain circumstances. Section 1115A(b)(3)(B) of the Act requires the Innovation Center to terminate or modify the design and implementation of a model, after testing has begun and before completion of the testing, unless the Secretary determines, and the Chief Actuary certifies with respect to program spending, that the model is expected to: improve the quality of care without increasing program spending; reduce program spending without reducing the quality of care; or improve the quality of care and reduce spending.

We propose at § 512.165(a) that CMS could terminate an Innovation Center model for reasons including, but not limited to, the following circumstances:

• CMS determines that it no longer has the funds to support the Innovation Center model; or

• CMS terminates the Innovation Center model in accordance with section 1115A(b)(3)(B) of the Act.

As provided by section 1115A(d)(2)(E) of the Act and proposed § 512.170, termination of the Innovation Center model in accordance with section 1115A(b)(3)(B) of the Act would not be subject to administrative or judicial review.

To ensure model participants had appropriate notice in the case of the termination of the Innovation Center model by CMS, we also propose to codify at § 512.165(b) that we would provide model participants with written notice of the model termination, which would specify the grounds for termination as well as the effective date of the termination.

K. Limitations on Review

In proposed § 512.170, we propose to codify the preclusion of administrative and judicial review under section 1115A(d)(2) of the Act. Section 1115A(d)(2) of the Act states that there is no administrative or judicial review under section 1869 or 1878 of the Act or otherwise for any of the following:

• The selection of models for testing or expansion under section 1115A of the Act.

• The selection of organizations, sites, or participants to test models selected.

• The elements, parameters, scope, and duration of such models for testing or dissemination.

• Determinations regarding budget neutrality under section 1115A(b)(3) of the Act.

• The termination or modification of the design and implementation of a model under section 1115A(b)(3)(B) of the Act.

• Determinations about expansion of the duration and scope of a model under section 1115A(c) of the Act, including the determination that a model is not expected to meet criteria described in paragraph (1) or (2) of such section.

We propose to interpret the preclusion from administrative and judicial review regarding the Innovation Center's selection of organizations, sites, or participants to test models selected to preclude from administrative and judicial review our selection of a model participant, as well as our decision to terminate a model participant, as these determinations are part of our selection

of participants for Innovation Center model tests.

In addition, we propose to interpret the preclusion from administrative and judicial review regarding the elements, parameters, scope, and duration of models for testing or dissemination to preclude from administrative and judicial review the following CMS determinations made in connection with an Innovation Center model:

• The selection of quality performance standards for the Innovation Center model by CMS.

• The assessment by CMS of the quality of care furnished by the model participant.

• The attribution of model beneficiaries to the model participant by CMS, if applicable.

We invite public comment on the proposed codification of these statutory preclusions of administrative and judicial review for models, as well as our proposed interpretations regarding their scope.

L. Miscellaneous Provisions on Bankruptcy and Other Notifications

Models currently being tested by the Innovation Center usually have a defined period of performance, but final payment under the model may occur long after the end of this performance period. In some cases, a model participant may owe money to CMS. We recognize that the legal entity that is the model participant may experience significant organizational or financial changes during and even after the period of performance for an Innovation Center model. To protect the integrity of the proposed Innovation Center models and Medicare funds, we are proposing a number of provisions to ensure that CMS is made aware of events that could affect a model participant's ability to perform its obligations under the Innovation Center model, including the payment of any monies owed to CMS.

First, in proposed § 512.180(a), we propose that a model participant must promptly notify CMS and the local U.S. Attorney Office if it files a bankruptcy petition, whether voluntary or involuntary. Because final payment may not take place until after the model participant ceases active participation in the Innovation Center model or any other model in which the model participant is participating or has participated (for example, because the period of performance for the model ends, or the model participant is no longer eligible to participate in the model), we further propose that this requirement would apply until final payment has been made by either CMS or such model participant under the terms of each model in which the model participant is participating or has participated and all administrative or judicial review proceedings relating to any payments under such models have been fully and finally resolved.

Specifically, we propose that notice of the bankruptcy must be sent by certified mail within 5 days after the bankruptcy petition has been filed and that the notice must contain a copy of the filed bankruptcy petition (including its docket number) and a list of all models tested under section 1115A of the Act in which the model participant is participating or has participated. To minimize the burden on model participants, while ensuring that CMS obtains the information necessary from model participants undergoing bankruptcy, we propose that the list need not identify a model in which the model participant participated if final payment has been made under the terms of the model and all administrative or judicial review proceedings regarding model-specific payments between the model participant and CMS have been fully and finally resolved with respect to that model. The notice to CMS must be addressed to the CMS Office of Financial Management, Mailstop C3-01-24, 7500 Security Boulevard, Baltimore, Maryland 21244 or to such other address as may be specified for purposes of receiving such notices on the CMS website.

By requiring the submission of the filed bankruptcy petition, CMS would obtain information necessary to protect its interests, including the date on which the bankruptcy petition was filed and the identity of the court in which the bankruptcy petition was filed. We recognize that such notices may already be required by existing law, but CMS often does not receive them in a timely fashion, and they may not specifically identify the models in which the individual or entity is participating or has participated. The failure to receive such notices on a timely basis can prevent CMS from asserting a claim in the bankruptcy case. We are particularly concerned that a model participant may not furnish notice of bankruptcy after it has completed its performance in a model, but before final payment has been made or administrative or judicial proceedings have been resolved. We believe our proposal is necessary to protect the financial integrity of the proposed Innovation Center models and the Medicare Trust Funds. Because bankruptcies filed by individuals and entities that owe CMS money are generally handled by CMS regional offices, we are considering (and solicit comment on) whether we should require model participants to furnish notice of bankruptcy to the local CMS regional office instead of, or in addition to, the Baltimore headquarters.

Second, in proposed § 512.180(b), we propose that the model participant, including model participants that are individuals, would have to provide written notice to CMS at least 60 days before any change in the model participant's legal name became effective. The notice of legal name change would have to be in a form and manner specified by CMS and include a copy of the legal document effecting the name change, which would have to be authenticated by the appropriate state official. The purpose of this proposed notice requirement is to ensure the accuracy of our records regarding the identity of model participants and the entities to whom model-specific payments should be made or against whom payments should be demanded or recouped. We solicit comment on the typical procedure for effectuating a legal entity's name change and whether 60 days' advance notice of such a change is feasible. Alternatively, we are considering requiring notice to be furnished promptly (for example, within 30 days) after a change in legal name has become effective. We invite public comment on this alternative approach.

Third, in proposed § 512.180(c), we propose that the model participant would have to provide written notice to CMS at least 90 days before the effective date of any change in control. We propose that the written notification must be furnished in a form and manner specified by CMS. For purposes of this notice obligation, we propose that a “change in control” would mean any of the following: (1) The acquisition by any “person” (as such term is used in sections 13(d) and 14(d) of the Securities Exchange Act of 1934) of beneficial ownership (within the meaning of Rule 13d-3 promulgated under the Securities Exchange Act of 1934), of beneficial ownership (within the meaning of Rule 13d-3 promulgated under the Securities Exchange Act of 1934), directly or indirectly, of voting securities of the model participant representing more than 50 percent of the model participant's outstanding voting securities or rights to acquire such securities; (2) the acquisition of the model participant by any individual or entity; (3) the sale, lease, exchange or other transfer (in one transaction or a series of transactions) of all or substantially all of the assets of the model participant; or (4) the approval and completion of a plan of liquidation of the model participant, or an

agreement for the sale or liquidation of the model participant. The proposed requirement and definition of change in control are the same requirements and definition used in certain models that are currently being tested under section 1115A authority. We believe this proposed notice requirement is necessary to ensure the accuracy of our records regarding the identity of model participants and to ensure that we pay and seek payment from the correct entity. For this reason, we propose that if CMS determined in accordance with proposed § 512.160(a)(5) that a model participant's change in control would present a program integrity risk, CMS could take remedial action against the model participant under proposed § 512.160(b). In addition, to ensure payment of amounts owed to CMS, we propose that CMS may require immediate reconciliation and payment of all monies owed to CMS by a model participant that is subject to a change in control.

We invite public comment on these proposed notification requirements. Also, we solicit comment as to whether the requirement to provide notice regarding changes in legal name and changes in control are necessary, or are already covered by existing reporting requirements for Medicare-enrolled providers and suppliers.

III. Proposed Radiation Oncology Model

A. Introduction

We are proposing a mandatory Radiation Oncology Model (RO Model), referred to in this section III. of the proposed rule as “the Model,” that would test whether prospective episode-based payments for radiotherapy (RT) services,

4

(also referred to as radiation therapy services) would reduce Medicare program expenditures and preserve or enhance quality of care for beneficiaries. As radiation oncology is highly technical and furnished in well-defined episodes, and because patient comorbidities generally do not influence treatment delivery decisions, we believe that radiation oncology is well-suited for testing a prospective episode payment model. Under this proposed RO Model, Medicare would pay participating providers and suppliers a site-neutral, episode-based payment for specified professional and technical RT services furnished during a 90-day episode to Medicare fee-for-service (FFS) beneficiaries diagnosed with certain cancer types. The base payment amounts for RT services included in the Model would be the same for hospital outpatient departments (HOPDs) and freestanding radiation therapy centers. The performance period for the proposed RO Model would be five performance years (PYs), beginning in 2020, and ending December 31, 2024, with final data submission of clinical data elements and quality measures in 2025 to account for episodes ending in 2024.

4

Radiotherapy (RT) services

(also referred to as radiation therapy services) are services associated with cancer treatment that use high

doses

of

radiation

to kill cancer

cells

and shrink tumors, and encompass treatment consultation, treatment planning, technical preparation and special services (simulation), treatment delivery, and treatment management.

We are including the following proposals for the Model in this proposed rule: (1) The scope of the Model, including required participants and episodes under the Model test; (2) the pricing methodology under the Model and necessary Medicare program policy waivers to implement such methodology; (3) the quality measures selected for the Model for purposes of scoring a participant's quality performance; (4) the process for payment reconciliation; and, (5) data collection and sharing.

B. Background

1. Overview

CMS is committed to promoting higher quality of care and improving outcomes for Medicare beneficiaries while reducing costs. Accordingly, as part of that effort, we have in recent years undertaken a number of initiatives to improve cancer treatment, most notably with our Oncology Care Model (OCM). We believe that a model in radiation oncology would further these efforts to improve cancer care for Medicare beneficiaries and reduce Medicare expenditures.

RT is a common treatment for nearly two thirds of all patients undergoing cancer treatment

5 6

and is typically furnished by a radiation oncologist. We analyzed Medicare FFS claims between January 1, 2015, and December 31, 2017, to examine several aspects (including but not limited to modalities, number of fractions, length of episodes, Medicare payments and sites of service, as described in this section) of radiation services furnished to Medicare beneficiaries during that period. We used HOPD and Medicare Physician Fee Schedule (PFS) claims, accessed through CMS's Chronic Conditions Data Warehouse (CCW), to identify all FFS beneficiaries who received any radiation treatment delivery services within that 3-year period. These radiation treatment delivery services included various types of modalities.

7

Such modalities included external beam radiotherapy (such as 3-dimensional conformal radiotherapy (3DCRT), intensity-modulated radiotherapy (IMRT), stereotactic radiosurgery (SRS), stereotactic body radiotherapy (SBRT), and proton beam therapy), intraoperative radiotherapy (IORT), image-guided radiation therapy (IGRT), and brachytherapy. We conducted several analyses of radiation treatment patterns using that group of beneficiaries and their associated Medicare Part A and Medicare Part B claims.

5

Physician Characteristics and Distribution in the U.5., 2010 Edition, 2004 IMV Medical Information Division, 2003 SROA Benchmarking Survey.

6

2012/13 Radiation Therapy Benchmark Report, IMV Medical Information Division, Inc. (2013).

7

Modality refers to various types of radiotherapy, which are commonly classified by the type of radiation particles used to deliver treatment.

Our analysis showed that from January 1, 2015 through December 31, 2017, HOPDs furnished 64 percent of episodes nationally, while freestanding radiation therapy centers furnished the remaining 36 percent of episodes. We intend to make this data publically accessible in a summary-level, de-identified file titled the “RO Episode File (2015-2017),” on the RO Model's website. Our analysis also showed that, on average, freestanding radiation therapy centers furnished (and billed for) a higher volume of RT services within such episodes than did HOPDs. Based on our analysis of Medicare FFS claims data from that time period, episodes of care in which RT was furnished at a freestanding radiation therapy center were, on average, paid approximately $1,800 (or 11 percent) more by Medicare than those episodes of care where RT was furnished at a HOPD. We are not aware of any clinical rationale that explains for these differences, which persisted after controlling for diagnosis, patient case mix (to the extent possible using data available in claims), geography, and other factors. These differences also persist even though Medicare payments are lower per unit in freestanding radiation therapy centers than in HOPDs. Upon further analysis, we observed that freestanding radiation therapy centers use more IMRT, a type of RT associated with higher Medicare payments, and perform more fractions (that is, more RT treatments) than HOPDs.

2. Site-Neutral Payments

Under Medicare FFS, RT services furnished in a freestanding radiation therapy center are paid under the

Medicare PFS at the non-facility rate including payment for the professional and technical aspects of the services. For RT services furnished in an outpatient department of a hospital, the facility services are paid under the Hospital Outpatient Prospective Payment System (OPPS) and the professional services are paid under the PFS. Differences in the underlying rate-setting methodologies used in the OPPS and PFS to establish payment for RT services in the HOPD and in the freestanding radiation therapy centers respectively help to explain why the payment rate for the same RT service could be different. This difference in payment rate, which is commonly referred to as the site-of-service payment differential, may incentivize Medicare providers and suppliers to deliver RT services in one setting over another, even though the actual treatment and care received by Medicare beneficiaries for a given modality is the same in both settings. We propose to test a site-neutral payment in the RO Model rather than implementing a payment adjustment in the OPPS or PFS because—

• The Secretary of Health and Human Services does not have the authority to adjust payments outside of established payment methodologies under the Section 1848 governing the PFS;

• The Practice Expense (PE) component of the PFS is determined based on inputs (labor, equipment, and supplies) and input price estimates from entities paid under the PFS only, which means the PE calculation cannot consider HOPD cost data that the RO Model proposes to use as the basis for national base rates;

(1) • Further, the PE methodology itself calculates a PE amount for each service relative to all of the other services paid under the PFS in a budget neutral manner and consistent with estimates of appropriate division of PFS payments between PE, physician work, and malpractice resource costs; and

(2) • Both the PFS and OPPS make the same payment for a service, irrespective of the diagnosis, whereas the RO Model establishes different payments by cancer type.

(3) • Neither payment system would allow flexibility in testing new and comparable approaches to value-based payment outside of statutory quality reporting programs.

We believe a site-neutral payment policy would address the site-of-service payment differential that exists under the OPPS and PFS by establishing a common payment amount to pay for the same services regardless of where they are furnished. In addition, we believe that site-neutral payments would offer RT providers and RT suppliers more certainty regarding the pricing of RT services and remove incentives that promote the provision of RT services at one site of service over another. The RO Model is designed to test these assumptions regarding site-neutrality.

3. Aligning Payments to Quality and Value, Rather Than Volume

For some cancer types, stages, and characteristics, a shorter course of RT treatment with more radiation per fraction may be appropriate. For example, several randomized controlled trials have shown that shorter treatment schedules for low-risk breast cancer yield similar cancer control and cosmetic outcomes as longer treatment schedules.

8 9 10 11

As another example, research has shown that radiation oncologists may split treatment for bone metastases into 5 to 10 fractions, even though research indicates that one fraction is often sufficient.

12 13 14 15

In addition, recent clinical trials have demonstrated that, for some patients in clinical trials with low- and intermediate-risk prostate cancer, courses of RT lasting 4 to 6 weeks lead to similar cancer control and toxicity as longer courses of RT lasting 7 to 8 weeks.

16 17

8

Whelan, T.J. et al. Long-term Results of Hypofractionated Radiation Therapy for Breast Cancer. N. Engl. J. Med. 2010 Feb. 11; 362(6):513-20.

https://www.ncbi.nlm.nih.gov/pubmed/20147717.

9

Bentzen, S.M. et al. The UK Standardisation of Breast Radiotherapy (START) Trial A of Radiotherapy Hypofractionation for Treatment of Early Breast Cancer: A Randomised Trial. Lancet Oncol. 2008 Apr.; 9(4):331-41.

https://www.ncbi.nlm.nih.gov/pubmed/18356109.

10

Bentzen, S.M. et al. The UK Standardisation of Breast Radiotherapy (START) Trial B of Radiotherapy Hypofractionation for Treatment of Early Breast Cancer: A Randomised Trial. Lancet Oncol. 2008 Mar. 29; 371(9618): 1098-107.

https://www.ncbi.nlm.nih.gov/pubmed/18355913.

11

Haviland, J.S. et al. The UK Standardisation of Breast Radiotherapy (START) Trials of Radiotherapy Hypofractionation for Treatment of Early Breast Cancer: 10-Year Follow-Up Results of Two Randomised Controlled Trials. Lancet Oncol. 2013 Oct.; 14(11): 1086-94.

https://www.ncbi.nlm.nih.gov/pubmed/24055415.

12

Sze, W.M. et al. Palliation of Metastatic Bone Pain: Single Fraction Versus Multifraction Radiotherapy—A Systematic Review of The Randomised Trials. Cochrane Database Syst. Rev. 2004; (2):CD004721.

https://www.ncbi.nlm.nih.gov/pubmed/15106258.

13

Chow, E. et al. Update on the Systematic Review of Palliative Radiotherapy Trials for Bone Metastases. Clin. Oncol. (R. Coll. Radiol.). 2012 Mar; 24 (2):112-24.

https://www.ncbi.nlm.nih.gov/pubmed/22130630.

14

Chow, Ronald et al. Efficacy of Multiple Fraction Conventional Radiation Therapy for Painful Uncomplicated Bone Metastases: A Systematic Review. Radiotherapy & Oncology: March 2017 Volume 122, Issue 3, Pages 323-331.

http://www.thegreenjournal.com/article/S0167-8140(16)34483-8/abstract.

15

Lutz, Stephen et al. Palliative Radiation Therapy for Bone Metastases: Update of an ASTRO Evidence-Based Guideline. Practical Radiation Oncology (2017) 7, 4-12.

http://www.practicalradonc.org/article/S1879-8500(16)30122-9/pdf.

16

D. Dearnaley, I. Syndikus, H. Mossop, et al. Conventional versus hypofractionated high-dose intensity-modulated radiotherapy for prostate cancer: 5-Year outcomes of the randomised, non-inferiority, phase 3 CHHiP trial. Lancet Oncol, 17 (2016), pp. 1047-1060.

http://www.sciencedirect.com/science/article/pii/S1470204516301024.

17

W.R. Lee, J.J. Dignam, M.B. Amin, et al. Randomized phase III noninferiority study comparing two radiotherapy fractionation schedules in patients with low-risk prostate cancer. J Clin Oncol, 34 (2016), pp. 2325-2332.

http://ascopubs.org/doi/full/10.1200/JCO.2016.67.0448.

Based on this review of claims data, we believe that the current Medicare FFS payment systems may incentivize selection of a treatment plan with a high volume of services over another medically appropriate treatment plan that requires fewer services. Each time a patient requires radiation, providers can bill for RT services and an array of necessary planning services to make the treatment successful.

18

This structure may incentivize providers and suppliers to furnish longer courses of RT because they are paid more for furnishing more services. Importantly, however, the latest clinical evidence suggests that shorter courses of RT for certain types of cancer would be equally effective and could improve the patient experience, potentially reduce cost for the Medicare program, and lead to reductions in beneficiary cost-sharing.

18

These planning and technical preparation services include dose planning, treatment aids, CT simulations, and other services.

There is also some indication that the latest evidence-based guidelines are not incorporated into practices' treatment protocols in a timely manner.

19

For example, while breast cancer guidelines have since 2008 recommended that radiation oncologists use shorter courses of treatment for lower-risk breast cancer (3 weeks versus 5 weeks), an analysis found that, as of 2017, only half of commercially insured patients actually received the shorter course of treatment.

20

19

http://www.npr.org/sections/health-shots/2017/10/21/558837836/many-breast-cancer-patients-receive-more-radiation-therapy-than-needed.

20

https://www.practicalradonc.org/cms/10.1016/j.prro.2018.01.012/attachment/775de137-63cb-4c5d-a7f9-95556340d0f6/mmc1.pdf.

4. CMS Coding and Payment Challenges

We identified several coding and payment challenges for RT services. Under the PFS, payment is set for each service using resource-based relative value units (RVUs). The RVUs have three components: Clinician work (Work), practice expense (PE), and

professional liability or malpractice insurance expense (MP). In setting the PE RVUs for services, we rely heavily on voluntary submission of pricing information for supplies and equipment, and we have limited means to validate the accuracy of the submitted information. As a result, it is difficult to establish the cost of expensive capital equipment, such as a linear accelerator, in order to determine PE RVUs for physicians' services that use such equipment.

21

21

CY 2014 PFS final rule with comment period, 78 FR 43296, 43286-43289, 43302-43311.

Further, we have examined RT services and their corresponding codes under our potentially misvalued codes initiative based on their high volume and increasing use of new technologies. Specifically, we reviewed codes for RT services for Calendar Years (CYs) 2009, 2012, 2013, and 2015 as potentially misvalued services. In general, when a code is identified as potentially misvalued, we finalize the code as misvalued and then review the Work and PE RVU inputs for the code. As a result of the review, the inputs can be adjusted either upward or downward. The criteria for identifying potentially misvalued codes are set forth in section 1848(c)(2)(K)(ii) of the Act.

Through annual rulemaking for the PFS, we review and adjust values for potentially misvalued services, and also establish values for new and revised codes. We establish Work and PE RVU inputs for new, revised, and potentially misvalued codes based on a review of information that generally includes, but is not limited to, recommendations received from the American Medical Association's RVS Update Committee (AMA/RUC), Health Care Professional Advisory Committee (HCPAC), Medicare Payment Advisory Commission (MedPAC), and other public commenters; medical literature and comparative databases; a comparison of the work for other codes within the PFS; and consultation with other physicians and health care professionals within CMS and other federal government agencies. We also consider the methodology and data used to develop the recommendations submitted to us by the RUC and other public commenters, and the rationale for their recommendations.

Through the annual rulemaking process previously described, we have reviewed and finalized payment rates for several RT codes over the past few years. The American Medical Association identified radiation treatment coding for review because of site of service anomalies. We first identified these codes as potentially misvalued services during CY 2012 under a screen called “Services with Stand-Alone PE Procedure Time.” We observed significant discrepancies between the 60-minute procedure time assumptions for IMRT. Public information suggested that the procedure typically took between 5 and 30 minutes. In CY 2015, the American Medical Association CPT® Editorial Panel revised the entire code set that describes RT delivery. CMS proposed values for these services in the CY 2016 proposed rule but, due to challenges in revaluing the new code set, finalized the use of G-codes that we established to largely mirror the previous radiation treatment coding structure.

22

The Patient Access and Medicare Protection Act (PAMPA) (Pub. L. 114-115), enacted on December 28, 2015, addressed payment for certain RT delivery and related imaging services under the PFS, and the Bipartisan Budget Act (BBA) of 2018 (Pub. L. 115-123) required the PFS to use the same service inputs for these codes as existed in 2016 for CY 2017, 2018, and 2019. (The PAMPA and BBA are discussed in detail in this rule).

22

See generally,

CY 2015 PFS final rule with comment period, 79 FR 67547; CY 2016 PFS final rule with comment period, 80 FR 70885; CY 2016 PFS correcting amendment, 81 FR 12024.

Despite the aforementioned challenges related to information used to establish payment rates for RT services, we have systematically attempted to improve the accuracy of payment for these codes under the PFS. While the potentially misvalued code review process is essential to the PFS, some stakeholders have expressed concern that changes in Work and PE RVUs have led to fluctuations in payment rates. Occasionally, changes in PE RVUs for one or more CPT® codes occur outside of the misvalued code review cycle if there are updates to the equipment and supply pricing. Any changes to CPT® code valuations, including supply and equipment pricing changes, are subject to public comment and review.

Although the same code sets generally are used for purposes of the PFS and OPPS, there are differences between the codes used to describe RT services under the PFS and the OPPS, and those in commercial use more broadly. We continue to use some CMS-specific coding, or HCPCS codes, in billing and payment for RT services under the PFS while OPPS is largely based on CPT® codes. As a result of coding and other differences, these payment systems utilize different payment rates and reporting rules for the same services, which contribute to site-of-service payment differentials. These differences in payment systems can create confusion for RT providers and RT suppliers, particularly when they furnish services in both freestanding radiation therapy centers and HOPDs.

Finally, there are coding and payment challenges specific to freestanding radiation therapy centers. Through the annual PFS rulemaking process, we receive comments from stakeholders representing freestanding radiation therapy centers and physicians who furnish services in freestanding radiation therapy centers. In recent years, these stakeholder comments have noted the differences and complexity in payment rates and policies for RT services between the PFS and OPPS; expressing particular concerns about differences in payment for RT services furnished in freestanding radiation therapy centers and HOPDs despite that the fixed, capital costs associated with linear accelerators that are used to furnish these services do not differ across settings; and raising certain perceived deficiencies in the PFS rate-setting methodology as it applies to RT services delivered in freestanding radiation therapy centers.

23

It is also important to note that even if we were able to obtain better pricing information for inputs, due to the differing rate-setting methodologies, PFS rates are developed in relation to other PFS office-based services, not to OPPS payment rates.

23

See generally,

CY 2018 PFS final rule with comment period, 82 FR 52976; CY 2015 PFS final rule with comment period, 79 FR 67547; CY 2014 PFS final rule with comment period, 78 FR 43296.

As previously noted, the PAMPA addressed payment for certain RT delivery and related imaging services under the PFS. Specifically, section 3 of the PAMPA directed CMS to maintain the 2016 code definitions, Work RVU inputs, and PE RVU inputs for 2017 and 2018 for certain RT delivery and related imaging services; prohibited those codes from being considered as potentially misvalued codes for 2017 and 2018; and directed the Secretary to submit a Report to Congress on development of an episodic alternative payment model (APM) for Medicare payment for radiation therapy services furnished in non-facility settings. Section 51009 of the BBA of 2018 extended these payment policies through 2019. In November 2017, we submitted the Report to Congress as required by section 3(b) of the PAMPA.

24

In the report, we discussed the current status

of RT services and payment, and reviewed model design considerations for a potential APM for RT services.

24

https://innovation.cms.gov/resources/radiationapm-pubforum.html

.

In preparing the Report to Congress, the Innovation Center conducted an environmental scan of current evidence, as well as held a public listening session followed by an opportunity for RT stakeholders to submit written comments about a potential APM. A review of the applicable evidence cited in the Report to Congress demonstrated that episode payment models can be a tool for improving quality of care and reducing expenditures. Episode payment models pay a fixed price based on the expected costs to deliver a bundle of services for a clinically defined episode of care. We believe that radiation oncology is a promising area of health care for episode payments, in part, based on the findings in the Report to Congress. While the report discusses several options for an APM, in this proposed rule, we propose what the Innovation Center has determined to be the best design for testing an episodic APM for RT services.

C. RO Model Proposed Regulations

In this proposed rule, we propose our policies for the RO Model, including model-specific definitions and the general framework for implementing the RO Model. We propose to define “performance year” (PY) as the 12-month period beginning on January 1 and ending on December 31 of each year during the model performance period. We propose to codify the term “performance year” at § 512.205 of our regulations.

In this proposed rule, we are including our proposed policies for each of the following: (1) The scope of the RO Model, including the Model participants, beneficiary population, and RT episodes that would be included in the test; (2) the pricing methodology under the Model and the Medicare program policy waivers necessary to implement such methodology; (3) the measure selection for the model, including performance scoring methodology and applying quality to payment; (4) the process for payment reconciliation; and (5) data collection and sharing.

We propose to codify RO Model policies at 42 CFR part 512, subpart B (proposed §§ 512.200 through 512.290). In addition, as we explain in section II of this proposed rule, if finalized, the general provisions proposed to be codified at §§ 512.100 through 512.180 would apply to the proposed RO Model.

1. Proposed Model Performance Period

We propose to test the RO Model for 5 PYs. We propose to define “model performance period” to mean January 1, 2020, the date the Model begins, through December 31, 2024, the last date during which episodes under the Model must be completed. Alternatively, we are considering delaying implementation to April 1, 2020 to give RO participants and CMS additional time to prepare. An April 2020 start date would only affect the length of PY1 which would be nine months. All other PYs would be 12 months. For all episodes to be completed by December 31, 2024, no new episodes may begin after October 3, 2024. We invite public comments on the proposed model performance period and potential participants' ability to be ready to implement the RO Model by January 1, 2020. We also seek comments on delaying the start of the model performance period to April 1, 2020.

2. Proposed Definitions

We propose at § 512.205 to define certain terms for the RO Model. We describe these proposed definitions in context throughout this section III of this proposed rule. We invite public comments on these proposed definitions.

3. Proposed Participants

We propose that certain Medicare participating HOPDs, physician group practices (PGPs), and freestanding radiation therapy centers that furnish RT services (RT providers or RT suppliers) in randomly selected Core-Based Statistical Areas (CBSAs), would be required to participate in the RO Model either as “Professional participants,” “Technical participants,” or “Dual participants” (as such terms are defined in section III.C.3.b of this proposed rule). We propose to define “RO participant” at § 512.205 as a PGP, freestanding radiation therapy center, or HOPD that participates in the RO Model pursuant to the criteria that we propose to establish at § 512.210. (See III.C.3.b Proposed RO Model Participants.) In addition, we note that the proposed definition of “model participant,” as defined in section III.C.3.b of this rule, would include a RO participant. In this section, we explain our proposals regarding mandatory participation, the types of entities that would be required to participate, and the geographic areas that would be subject to the RO Model test.

a. Proposed Required Participation

We propose that certain RT providers and RT suppliers that furnish RT services within randomly selected CBSAs would be required to participate in the RO Model (see III.C.3.b. of this proposed rule (Proposed RO Model Participants) and III.C.3.d. of this proposed rule (Geographic Unit of Section)). To date, the Innovation Center has tested one voluntary prospective episode payment model, Bundled Payments for Care Improvement (BPCI) Model 4 that attracted only 23 participants, of which 78 percent withdrew from the initiative. As such, we are interested in testing and evaluating the impact of a prospective payment approach for RT services in a variety of circumstances. We believe that by requiring the participation of RT providers and RT suppliers, we would have access to more complete evidence of the impact of the Model.

A representative sample of RT providers and RT suppliers for the proposed Model would result in a robust data set for evaluation of this prospective payment approach, and would stimulate the rapid development of new evidence-based knowledge. Testing the Model in this manner would also allow us to learn more about patterns of inefficient utilization of health care services and how to incentivize the improvement of quality for RT services. This learning could potentially inform future Medicare payment policy. Therefore, we are proposing a broad, representative sample of RT providers and RT suppliers in multiple geographic areas (see Section III.C.3.d. of this proposed rule for a discussion regarding the Geographic Unit of Selection). We determined that the best method for obtaining the necessary diverse, representative group of RT providers and RT suppliers would be random selection. This is because a randomly selected sample would provide analytic results that would be more generally applicable to all Medicare FFS RT providers and RT suppliers and would allow for a more robust evaluation of the Model.

In addition, actuarial analysis suggests that the difference in estimated price updates for rates in the OPPS and PFS systems from 2019 through 2023, in which the OPPS rates are expected to increase substantially more than PFS rates, would result in few to no HOPDs electing to voluntarily participate in the Model. Further, actuarial estimates suggested that freestanding radiation therapy centers with historically lower RT costs compared to the national average would most likely choose to participate, but those with historically higher costs would be less likely to voluntarily participate. Requiring

participation in the RO Model would ensure sufficient proportional participation of both HOPDs and freestanding radiation therapy centers, which is necessary to obtain a diverse, representative sample of RT providers and RT suppliers and to help support a statistically robust test of the prospective episode payments made under the RO Model.

For these reasons, we believe that a mandatory model design would be the best way to improve our ability to detect and observe the impact of the prospective episode payments made under the RO Model. We therefore propose that participation in the RO Model would be mandatory for all RT providers and RT suppliers furnishing RT services within the randomly selected CBSAs.

We invite public comments on our proposal for mandatory participation.

b. Proposed RO Model Participants

A RO participant, a term that we propose to define at § 512.205, would be a Medicare-enrolled PGP, freestanding radiation therapy center, or HOPD that is required to participate in the RO Model pursuant to § 512.210. A RO participant would participate in the Model as a Professional participant, Technical participant, or Dual participant.

We propose to define the term “Professional participant” as a RO participant that is a Medicare-enrolled physician group practice (PGP), identified by a single Taxpayer Identification Number (TIN) that furnishes only the professional component of RT services at either a freestanding radiation therapy center or a HOPD. Professional participants would be required annually to attest to the accuracy of an individual practitioner list, as described in section III.C.9, provided by CMS, of all of the eligible clinicians who furnish care under the Professional participant's TIN. We propose to define the term “individual practitioner” to mean a Medicare-enrolled physician (identified by an NPI) who furnishes RT services to Medicare FFS beneficiaries, and have reassigned his/her billing rights to the TIN of a RO participant. We further propose that an individual practitioner under the RO Model would be considered a downstream participant, as defined in section II.B. of this proposed rule.

We propose to define the term “Technical participant” to mean a RO participant that is a Medicare-enrolled HOPD or freestanding radiation therapy center, identified by a single CMS Certification Number (CCN) or TIN, which furnishes only the technical component of RT services. Finally, we propose to define “Dual participant” to mean a RO participant that furnishes for both the professional component and technical component of an episode for RT services through a freestanding radiation therapy center, identified by a single TIN. We propose to codify the terms “Professional participant,” “Technical participant,” “Dual participant” and “individual practitioner” at § 512.205.

As previously explained, a RO participant would furnish at least one component of an episode, which we are proposing to have two components: A professional component and a technical component. We propose to define the term “professional component (PC)” to mean the included RT services that may only be furnished by a physician. We propose to define the term “technical component (TC)” to mean the included RT services that are not furnished by a physician, including the provision of equipment, supplies, personnel, and costs related to RT services. (See section III.C.5.c. of this proposed rule for a discussion regarding our proposed included RT services.) We propose to codify the terms “professional component (PC)” and “technical component (TC)” at § 512.205.

An episode of RT under the RO Model would be furnished by either: (1) Two separate RO participants, that is, a Professional participant that furnishes only the PC of an episode, and a Technical participant that furnishes only the TC of an episode; or (2) a Dual participant that furnishes both the PC and TC of an episode. For example, if a PGP furnishes only the PC of an episode at a HOPD that furnishes the TC of an episode, then the PGP would be a Professional participant and the HOPD would be a Technical participant. In other words, the PGP and HOPD would furnish separate components of the same episode and would be separate participants under the Model.

c. Proposed RO Model Participant Exclusions

We propose to exclude from RO Model participation any PGP, freestanding radiation therapy center, or HOPD that—

• Furnishes RT only in Maryland;

• Furnishes RT only in Vermont;

• Furnishes RT only in U.S. Territories;

• Is classified as an ambulatory surgery center (ASC), critical access hospital (CAH), or Prospective Payment System (PPS)-exempt cancer hospital; or

• Participates in or is identified as eligible to participate in the Pennsylvania Rural Health Model.

These exclusion criteria would apply during the entire model performance period. If a RO participant undergoes changes such that one or more of the proposed exclusion criteria becomes applicable to the RO participant during the model performance period, then that RO participant would be excluded from the RO Model (that is, it would no longer be a RO participant subject to inclusion criteria). For example, if a RO participant moves its only service location

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from a randomly selected CBSA in Virginia to Maryland, it would be excluded from the RO Model from the date of its location change. Conversely, if a PGP, freestanding radiation therapy center, or HOPD satisfies the exclusion criteria when the Model begins, and subsequently experiences a change such that the proposed exclusion criteria no longer apply and the PGP, freestanding radiation therapy center, or HOPD is located in one of the randomly selected CBSAs, then participation in the RO Model would be required. For example, if an HOPD is no longer classified as a PPS-exempt hospital and the HOPD is located in one of the randomly selected CBSAs, then the HOPD would become an RO participant from the date that the HOPD became no longer classified as a PPS-exempt hospital.

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Service location means the site of service in which a RO Participant or any RT provider or RT supplier furnishes RT services.

In the case of Professional participants and Dual participants, any episodes in which the initial RT treatment planning service is furnished to a RO beneficiary on or after the day of this change would be included in the Model. In the case of Technical participants, any episodes where the RT service is furnished within 28 days of a RT treatment planning service for a RO beneficiary and the RT service is furnished on or after the day of this change would be included in the Model.

We propose to exclude RT providers and RT suppliers in Maryland due to the unique statewide payment model being tested there (the Maryland Total Cost of Care Model), in which Maryland hospitals receive a global budget. This global budget includes RT services and as such would overlap with the RO Model payment; thus, we propose to exclude Maryland HOPDs to avoid double payment for the same services. We propose to extend the exclusion to all RT providers and RT suppliers in Maryland to avoid creating a gaming opportunity where certain beneficiaries

could be shifted away from PGPs and freestanding centers to HOPDs.

We propose to exclude RT providers and RT suppliers in Vermont due to the Vermont All-Payer ACO Model, which is a statewide model in which all-inclusive population-based payments (AIPBPs) are currently made to the participating ACO for Medicare FFS services furnished by all participating HOPDs and an increasing number of participating PGPs. Given the scope of this model as statewide and inclusive of all significant payers, we believe excluding RT providers and RT suppliers in Vermont from the RO Model is appropriate to avoid any potential interference with the testing of the Vermont All-Payer ACO Model.

We propose to exclude HOPDs that are participating in or eligible to participate in the Pennsylvania Rural Health Model. HOPDs that are participating in the model receive a global budget similar to the Maryland Total Cost of Care Model. Further, we propose to extend the exclusion to HOPDs that are eligible to participate in the Pennsylvania Rural Health Model because they may be added to that model in the future or may be included in the evaluation comparison group for that model. We would identify the CAHs and acute care hospitals that are participating or are eligible to participate in the Pennsylvania Rural Health Model on a list to be updated quarterly and made available on the Pennsylvania Rural Health Model's website at

https://innovation.cms.gov/initiatives/pa-rural-health-model/.

The proposed RO Model is designed to test whether prospective episode payments in lieu of traditional FFS payments for RT services would reduce Medicare expenditures by providing savings for Medicare while preserving or enhancing quality. We believe it would be inappropriate to include these entities for the reasons previously described. Also, we are proposing to exclude ASCs and RT providers and RT suppliers located in the U.S. Territories, as proposed at § 512.210, due to the low volume of RT services that they provide. In addition, we are proposing to exclude CAHs and PPS-exempt cancer hospitals due to the differences in how they are paid by Medicare.

As a result, we propose that RT services furnished by these RT providers and RT suppliers would be excluded from participation in the RO Model. If in the future we determine that providers and suppliers in these categories should be included in the RO Model, we would propose to revise our inclusion criteria through rulemaking.

We further propose to codify these policies at § 512.210 of our regulations.

We invite public comments on these proposals.

d. Proposed Geographic Unit of Selection

We propose that the geographic unit of selection for the RO Model would be OMB's Core Based Statistical Areas (CBSAs). Due to geographic data limitations on Medicare claim submissions, we would link RT providers and RT suppliers to a CBSA by using the five-digit ZIP Code of the location where RT services are furnished. This would permit us to identify RO Model participants (see section III.C.3.c. of this proposed rule RO Model Participant Exclusions for the RT providers and RT suppliers we are proposing to exclude from the RO Model) while still using CBSA as a geographic unit of selection. We further propose to codify the term “Core Based Statistical Area (CBSA)” at § 512.205 of our regulations.

CBSAs are delineated by the Office of Management and Budget and published on

Census.gov

.

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A CBSA is a statistical geographic area with a population of at least 10,000, which consists of a county or counties anchored by at least one core (urbanized area or urban cluster), plus adjacent counties having a high degree of social and economic integration with the core (as measured through commuting ties with the counties containing the core). CBSAs are ideal for use in statistical analyses because they are sufficiently numerous to allow for a robust evaluation and are also large enough to reduce the number of RO participants in close proximity to other RT providers and RT suppliers that would not be required to participate in the Model. CBSAs do not include the extreme rural regions, but there are very few RT providers and RT suppliers in these areas such that, if included, the areas would likely not generate enough episodes to be included in the statistical analysis; further, CBSAs do contain rural RT providers and RT suppliers as designated by CMS and Health Resources and Services Administration (HRSA). Therefore, CBSAs would capture the diversity of RT providers and RT suppliers who may be affected by the RO Model, and as such, we do not propose to include non-CBSA geographies in the RO Model test.

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See OMB Bulletin No. 18-04 entitled “Revised Delineations of Metropolitan Statistical Areas, Micropolitan Statistical Areas, and Combined Statistical Areas, and Guidance on Uses of the Delineations of These Areas,”

https://www.census.gov/programs-surveys/metro-micro/about/omb-bulletins.html

.

However, most RT providers and RT suppliers may not know in what CBSA they furnish RT services. In order to simplify the notification process to inform RT providers and RT suppliers whether or not they furnish RT services in a selected CBSA, we are proposing to use an RT provider's or RT supplier's service location five-digit ZIP Code found on the RT provider's or RT supplier's claim submissions to CMS to link them to CBSAs selected under the Model.

Not all five-digit ZIP Codes fall entirely within OMB delineated CBSA boundaries, resulting in some five-digit ZIP Codes assigned to two different CBSAs. Approximately 15 percent (15 percent) of five-digit ZIP Codes have portions of their addresses located in more than one CBSA. If each ZIP Code was assigned only to the CBSA with the largest portion of delivery locations in it, about 5 percent of all delivery locations in ZIP Codes would be assigned to a different CBSA. Rather than increase provider burden by requiring submission of more detailed geographic data by RT providers and RT suppliers, we propose to assign the entire five-digit ZIP Code to the CBSA where the ZIP code has the greatest portion of total addresses (business, residence, and other addresses) such that each five-digit ZIP Code is clearly linked to a unique CBSA or non-CBSA geography. In the event that the portion of total addresses within the five-digit ZIP Code is equal across CBSAs and cannot be used to make the link, the greater portion of business addresses would take precedence to link the five-digit ZIP Code to the CBSA.

CMS would use a five-digit ZIP Code to CBSA crosswalk found in the Housing and Urban Development (HUD) ZIP to CBSA Crosswalk file

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to link each five-digit ZIP Code to a single CBSA. The HUD ZIP to CBSA Crosswalk file lists the ZIP Codes (which come from the United States Postal Service) that correspond with the CBSAs (which are Census Bureau geographies) in which those ZIP Codes exist, allowing these two methods of geographic identification to be linked.

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Datasets and documentation for HUD USPS Zip Code Crosswalk Files (which includes the above mentioned HUD ZIP-CBSA crosswalk file) can be found here:

https://www.huduser.gov/portal/datasets/usps_crosswalk.html.

We believe that linking a five-digit ZIP Code to a single CBSA would not substantially impact statistical estimates for the RO Model. In addition, we believe that using a service location's five-digit ZIP Code to determine

whether an RT provider or RT supplier must participate in the Model will avoid potential RT provider or RT supplier burden by avoiding an additional requirement that they submit claims using more detailed geographic information. If finalized as proposed, CMS would provide a look-up tool that includes all five-digit ZIP Codes linked to CBSAs selected in accordance with our proposed selection policy described in this proposed rule. This tool would be located on the RO Model website.

Using CBSAs to identify RO participants would enable CMS to analyze groups of RT providers and RT suppliers in areas selected to participate in the Model and compare them to groups of RT providers and RT suppliers not participating in the Model. To the extent that CBSAs act like or represent markets, these group analyses would allow CMS to observe potential group level, market-like effects. We have found group level effects important as context for understanding the results of other models tested under section 1115A of the Act. For example, stakeholders questioned whether a model changed the overall volume of services related to the specific model in a given area. We would not be able to address this issue for the RO Model without using a geographic area as the unit of analysis.

With respect to selecting CBSAs under the Model, we propose to use a stratified sample design based on the observed ranges of episode counts in CBSAs using claims data from calendar years 2015-2017. We would then randomize the CBSAs within each stratum into participant and comparison groups until the targeted number of RO episodes within each group of CBSAs needed for a robust

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test of the Model is reached. The primary purpose of the evaluation is to estimate the impact of the Model across all participating organizations. Larger sample sizes decrease the chances that the evaluation would produce mistakes, that is show `no effect' when an effect is actually present (like an instance when a smoke detector fails to sound an alarm even though smoke is actually present) or show `an effect' when no effect is actually present (like an instance when a smoke detector is sounding an alarm that suggests smoke is detected when actually no smoke is present). Given that we plan to sample 40 percent of all eligible RO episodes in eligible CBSAs nationwide (as defined in section III.C.5 of this proposed rule), we believe we should be sufficiently powered (that is, the sample size and the expected size of the effect of the Model are both large enough at a given significance level) to confidently show the impact of the Model. The comparison group would consist of RT providers and RT suppliers from randomized CBSAs within the same strata as the selected RO participants from the participant group, resulting in a comparison group of an approximately equal number of CBSAs and episodes as in the participant group that would allow for the effects of the RO Model to be evaluated. Strata will be divided into five quintiles based on the total number of episodes within a given CBSA. The stratification would limit uneven RT provider and RT supplier and episode numbers within the participant and comparison groups of CBSAs that can result from a simple random sample. If a CBSA is randomly assigned to the participant group, then the RT providers and RT suppliers who furnish RT services in that CBSA would be RO participants. If the CBSA is randomly assigned to the comparison group, then the providers and suppliers who furnish RT services in that CBSA would not be RO participants, but the claims they generate and the episodes constructed from those claims would be used as part of the RO Model's evaluation.

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`Robust' in statistical terminology means that we can have high confidence in the test results under a broad range of conditions, for example, lower quality data, a shortened test period, or other unexpected complications.

After determining the sampling framework, we conducted the necessary power calculations (statistical tests to determine the minimum sample size of the participant and comparison groups in the Model, designed in order to produce robust and reliable results) using Medicare FFS claims from January 1, 2015 through December 31, 2017, to construct episodes and then identify a sufficient sample size so that results would be precise and reliable. We determined that 40 percent of eligible episodes (as defined in section III.C.5 of this proposed rule) in eligible CBSAs nationally would allow for a rigorous test of the RO Model that would produce evaluation results that we can be confident are accurately reflecting what actually occurred in the Model test, and that this size would limit the number of episodes expected in the participant group to no more than is needed for a robust statistical test of the projected impacts of the Model.

Using randomly selected stratified CBSAs would ensure that the participant and comparison groups of CBSAs would each contain approximately 40 percent of all eligible episodes nationally. The comparison group of CBSAs would be used to evaluate the impact of the RO Model on spending, quality, and utilization. The CBSAs would be randomly selected and those CBSAs and the ZIP Codes selected for participation would be published on the RO Model website once the final rule is displayed.

4. Proposed Beneficiary Population

We propose that a Medicare FFS beneficiary be included in the RO Model if the beneficiary:

• Receives included RT services in a five-digit ZIP Code linked to a selected CBSA from a RO participant during the model performance period for a cancer type that meets the criteria for inclusion in the RO Model; and

• At the time that the initial treatment planning service of the episode is furnished by a RO participant, the beneficiary:

++ Is eligible for Medicare Part A and enrolled in Medicare Part B; and

++ Has traditional Medicare FFS as his or her primary payer.

In addition, we propose to exclude from the RO Model any beneficiary who, at the time that the initial treatment planning service of the episode is furnished by a RO participant:

• Is Enrolled in any Medicare managed care organization, including but not limited to Medicare Advantage plans;

• Is Enrolled in a PACE plan;

• Is not in a Medicare hospice benefit period; or

• Is covered under United Mine Workers.

Because the RO Model would evaluate RT services furnished to beneficiaries who have been diagnosed with one of the cancer types identified as satisfying our proposed criteria for inclusion in the Model, as discussed in section III.C.5.a, we believe it would be necessary to include only beneficiaries who have at least one of the identified cancer types and who also receive RT services from RO participants. Further, a key objective of the RO Model would be to evaluate if and/or how RT service delivery changes in either the HOPD or freestanding radiation therapy center setting as a result of a change in payment systems from that of FFS under OPPS or PFS, respectively, to that of prospectively determined bundled rates for an episode of RT services as described in section III.C.6.c. We propose these criteria in order to limit RT provider and RT supplier participation in the RO Model to beneficiaries whose RT providers and RT suppliers would otherwise be paid by way of traditional FFS payments for the identified cancer types. We believe that these eligibility criteria for RO

beneficiaries are necessary in order to properly evaluate this change with minimal intervening effects.

We propose that a beneficiary who meets all of these criteria, and who does not trigger any of the beneficiary exclusion criteria, would be called a “RO beneficiary”. We propose to codify the terms “RO beneficiary,” “RT provider,” and “RT supplier” at § 512.205.

In addition, we propose to include in the RO Model any beneficiary participating in a clinical trial for RT services for which Medicare pays routine costs, provided that such beneficiary meets all of the proposed beneficiary inclusion criteria. We would consider routine costs of a clinical trial to be all items and services that are otherwise generally available to Medicare beneficiaries (that is, there exists a benefit category, it is not statutorily excluded, and there is not a national non-coverage decision) that are provided in either the experimental or the control arms of a clinical trial.

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Medicare pays routine costs by way of FFS payments, making it appropriate to include RT services furnished for RO episodes in this case under the RO Model.

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The current Medicare policy on routine cost in clinical trials is described in Routine Costs in Clinical Trials 100-3 section 310.1.

The RO Model's proposed design would not allow RO beneficiaries to “opt out” of the Model's pricing methodology. A beneficiary who is included in the RO Model pursuant to the previously proposed criteria would have his or her RT services paid for under the Model's pricing methodology and would be responsible for the coinsurance amount as described in section III.C.6.i. Beneficiaries do have the right to choose to receive RT services in a geographic area not included in the RO Model.

If a RO beneficiary stops meeting any of the proposed eligibility criteria or triggers any of the exclusion criteria (see section III.C.4. of this proposed rule) before the TC of an episode initiates, then the episode would be an incomplete episode as described in section III.C.6.a. of this proposed rule Payments to RO participants will be retrospectively adjusted to account for incomplete episodes during the annual reconciliation process, as described in section III.C.11. of this proposed rule.

If traditional Medicare stops being an RO beneficiary's primary payer after the TC of the episode has been initiated, then regardless of whether the beneficiary's course of RT treatment was completed, the 90-day period would be considered an incomplete episode and, the RO participant would receive only the first installment of the episode payment. In the event that a beneficiary dies or enters hospice during an episode, then the RO participant would receive both installments of the episode payment, regardless of whether the RO beneficiary's course of RT has ended (see section III.C.7. of this proposed rule).

We are proposing these beneficiary eligibility criteria for purposes of determining beneficiary inclusion in and exclusion from the Model.

5. Proposed RO Model Episodes

In this proposed RO Model, Medicare would pay RO participants a site-neutral, episode-based payment amount for all specified RT services furnished to a RO beneficiary during a 90-day episode. In this section, we first explain our proposal to include criteria to add or remove cancer types under the Model and their relevant diagnoses codes in the Model as well as the RT services and modalities that would be covered and not covered in an episode payment for treatment of those cancer types. We then explain our proposal for testing a 90-day episode and propose the conditions that must be met to trigger an episode.

a. Proposed Included Cancer Types

We propose the following criteria for purposes of including cancer types under the RO Model. The cancer type—

• Is commonly treated with radiation; and

• Has associated current ICD-10 codes that have demonstrated pricing stability.

We further propose to codify these criteria for included cancer types at § 512.230(a) of our regulation.

We propose the following criteria for purposes of removing cancer types under the RO Model.

• RT is no longer appropriate to treat a cancer type per nationally recognized, evidence-based clinical treatment guidelines;

• CMS discovers a ≥10 percent (≥10%) error in established national baseline rates; or

• The Secretary determines a cancer type not to be suitable for inclusion in the Model.

We further propose to codify these criteria for removing cancer types at § 512.230(b) of our regulation.

We identified 17 cancer types in Table 1 that meet our proposed criteria. These 17 cancer types are commonly treated with RT and Medicare claims data was sufficiently reliable to calculate prices for prospective episode payments that accurately reflect the average resource utilization for an episode. These cancer types are made up of specific ICD-9 and ICD-10 diagnosis codes. For example, as shown in Table 1, there are cancer types for “breast cancer” and “prostate cancer,” which are categorical terms that represent a grouping of ICD-9 and ICD-10 codes affiliated with those conditions. To identify these cancer types and their relevant diagnosis codes to include in the Model, we identified cancers that are treated with RT.

Using the list of cancer types and relevant diagnosis codes, we analyzed the interquartile ranges of the episode prices across diagnosis codes within each cancer type to determine pricing stability. We chose to exclude benign neoplasms and those cancers that are rarely treated with radiation because there were not enough episodes for reliable pricing and they were too variable to pool.

During our review of skin cancer episodes, we discovered that Current Procedural Terminology® (CPT®) code 0182T (electronic brachytherapy treatment), which was being used mainly by dermatologists to report treatment for non-melanoma skin cancers, was deleted and replaced with two new codes (CPT® code 0394T to report high dose rate (HDR) electronic skin brachytherapy and 0395T to report HDR electronic interstitial or intracavitary treatments) in 2016. Local coverage determinations (LCDs) that provide information about whether or not a particular item or service is covered were created and subsequently changed during this time period. Our analysis suggested that the volume and pricing of these services dropped significantly between 2015 and 2016, with pricing decreasing more than 50 percent. As a result, we did not believe that we could price episodes for skin cancers that accurately reflect the average resource utilization for an episode. Thus, skin cancer was excluded.

We are proposing that the RO Model's included cancer types would include those that are commonly treated with RT and that can be accurately priced for prospective episode payments. An up-to-date list of cancer types would be kept on the RO Model website.

We propose to define the term “included cancer types” to mean the

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

EP18JY19.000

We would maintain the list of ICD-10 codes for included cancer types under the RO Model on the RO Model website. Any addition or removal of these proposed cancer types would be communicated via the RO Model website and written correspondence to RO participants. We would notify RO participants of any changes to the diagnosis codes for the included cancer types per the CMS standard process for announcing coding changes and update the list on the RO Model website no later than 30 days prior to each PY.

We invite public comments on our proposal.

b. Episode Length and Trigger

(1) Proposed Episode Length

We are proposing that the length of an episode under the RO Model be 90 days. Based on the analysis of Medicare claims data between January 1, 2014 and December 30, 2015, approximately 99 percent of beneficiaries receiving RT completed their course of radiation within 90 days of their initial treatment planning service. Day 1 would be the date of service that a Professional participant or Dual participant furnishes the initial treatment planning service (included in the PC), provided that a Technical participant or Dual participant furnishes an RT delivery service (included in the TC) within 28 days of the treatment planning service. In other words, the relevant 90-day period would be considered an episode only if a Technical participant or Dual participant furnishes the TC to an RO beneficiary within 28 days of when a Professional participant or Dual participant furnishes the PC to such RO beneficiary. When those circumstances

occur, the “start” of the episode would be the date of service that the initial treatment planning service was rendered. If, however, a Technical participant or Dual participant does not furnish the TC to an RO beneficiary within the 28-day period, then no episode will have occurred and any payment would be made to the RO participant in accordance with our incomplete episode policy. We refer readers to sections III.C.5.b and III.C.6.a for an overview of our proposed episode trigger and incomplete episode policies, respectively.

To better understand the standard length of a course of RT, we analyzed Medicare claims for beneficiaries who received any RT services between January 1, 2014 and December 30, 2015. Preliminary analysis showed that average Medicare spending for radiation treatment tends to drop significantly 9 to 11 weeks following the initial RT service for most diagnoses, including prostate, breast, lung, and head and neck cancers. Furthermore, based on this data, approximately 99 percent of beneficiaries receiving RT completed their course of radiation within 90 days of their initial treatment planning service. We intend to make a summary-level, de-identified file titled the “RT Expenditures by Time” available on the RO Model's website that supports our findings in this preliminary analysis.

Based on our analysis, for the purpose of establishing the national base rates for the PC and TC of each episode for each cancer type, episodes were triggered by the occurrence of a treatment planning service followed by a radiation treatment delivery service within 28 days of the treatment planning service (HCPCS codes 77261-77263). In addition, for the purpose of establishing the national base rates in section III.C.6.c, the episodes lasted for 89 days starting from the day after the initial treatment planning service in order to create a full 90-day episode.

Based on these analyses, we are proposing a 90 day episode duration.

(2) Proposed Episode Trigger

Because we only want to include episodes in which beneficiaries actually receive RT services, we propose that an episode would be triggered only if both of the following conditions are met: (1) There is an initial treatment planning service (that is, submission of treatment planning HCPCS codes 77261-77263, all of which would be included in the PC) furnished by a Professional participant or a Dual participant; and (2) at least one radiation treatment delivery service (as listed in Table 2: List of RO Model Bundled HCPCS) is furnished by a Technical participant or a Dual participant within the following 28 days. The PC is attributed to the RT supplier of the initial radiation treatment planning service. The TC is attributed to the RT provider or RT supplier of the initial radiation treatment delivery service. As we previously explained, an episode that is triggered would end 89 days after the date of the initial treatment planning service, creating a 90 day episode. If, however, a beneficiary receives an initial treatment planning service but does not receive RT treatment from a Technical participant or Dual participant within 28 days, then the requirements for triggering an episode would not be met, and no RO episode will have occurred, and the proposed incomplete episode policy would take effect.

In those cases where the TC of an episode is not furnished by a Dual participant (that is, when the same RO participant does not furnish both the PC and the TC of an episode), the Professional participant would provide the Technical participant with a signed radiation prescription and the final treatment plan, all of which is usually done electronically. This will inform the Technical participant of when the episode began.

(3) Proposed Policy for Multiple Episodes and the Clean Period

Given our findings that 99 percent of Medicare FFS beneficiaries complete treatment within 90 days of the initial treatment planning service, and to minimize any potential incentive for a RO participant to extend a treatment course beyond the 90-day episode in order to trigger a new episode, we propose that another episode may not be triggered until at least 28 days after the previous episode has ended. This is because, while a missed week of treatment is not uncommon, a break from RT services for more four weeks (or 28 days) generally signals the start of a new course of treatment.

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We refer to the 28-day period after an episode has ended, during which time a RO participant would bill for medically necessary RT services furnished to a RO beneficiary in accordance with Medicare FFS billing rules, as the “clean period.” We propose to codify the term “clean period” at § 512.205 of our regulations.

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CMS was advised by radiation oncologists consulting on the design of the Model that four weeks signals the start of a new course of treatment.

If clinically appropriate, a RO participant may initiate another episode for the same beneficiary after the 28-day clean period has ended. During the clean period, a RO participant would be required to bill for RT services for the beneficiary in accordance with FFS billing rules. The Innovation Center would monitor the extent to which services are furnished outside of 90-day episodes, including during clean periods, and for the number of RO beneficiaries who receive RT in multiple episodes.

We invite public comment on our proposal.

c. Proposed Included RT Services

We propose that the RO Model would include most RT services furnished in HOPDs and freestanding radiation therapy centers. Services furnished within an episode of RT usually follow a standard, clearly defined process of care and generally include a treatment consultation, treatment planning, technical preparation and special services (simulation), treatment delivery, and treatment management, which are also categorical terms used to generally describe RT services. The subcomponents of RT services have been described in the following manner:

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31

American Society for Radiation Oncology (ASTRO). Basics of RO Coding.

https://www.astro.org/Basics-of-Coding.aspx.

Consultation:

A consultation is an evaluation and management (E&M) service, which typically consists of a medical exam, obtaining a problem-focused medical history, and decision making about the patient's condition/care.

Treatment planning: Treatment planning tasks include determining a patient's disease-bearing areas, identifying the type and method of radiation treatment delivery, specifying areas to be treated, and selecting radiation therapy treatment techniques. Treatment planning often includes simulation (the process of defining relevant normal and abnormal target anatomy and obtaining the images and data needed to develop the optimal radiation treatment process). Treatment planning may involve marking the area to be treated on the patient's skin, aligning the patient with localization lasers, and/or designing immobilization devices for precise patient positioning.

Technical preparation and special services: Technical preparation and special services include radiation dose planning, medical radiation physics, dosimetry, treatment devices, and special services. More specifically, these services also involve building treatment devices to refine treatment delivery and mathematically determining the dose

and duration of radiation therapy. Radiation oncologists frequently work with dosimetrists and medical physicists to perform these services.

Radiation treatment delivery services: Radiation treatment is usually furnished via a form of external beam radiation therapy or brachytherapy, and includes multiple modalities. Although treatment generally occurs daily, the care team and patient determine the specific timing and amount of treatment. The treating physician must verify and document the accuracy of treatment delivery as related to the initial treatment planning and setup procedure.

Treatment management: Radiation treatment management typically includes review of port films, review and changes to dosimetry, dose delivery, treatment parameters, review of patient's setup, patient examination, and follow-up care.

Our claims analysis revealed that beneficiaries received a varying number of consultations from different physicians prior to the treatment planning visit, which determines the prescribed course of radiation therapy, including modality and number of treatments to be delivered. We are proposing to include treatment planning, technical preparation and special services, treatment delivery, and treatment management as the RT services in an episode paid for by CMS, and we propose to codify this at § 512.235. E&M services are furnished by a wide range of physician specialists (for example, primary care, general oncology, others) whereas the other radiation services are typically only furnished by radiation oncologists and their team. This is reflected in the HCPCS code set used to bill for these services. In our review of claims data, many different types of specialists furnish E&M services. It is common for multiple entities to bill for treatment consultations (E&M services) for the same beneficiary, whereas typically only a single entity bills for RT services for a beneficiary when we limited the services considered to treatment planning, technical preparation and special services, treatment delivery, and treatment management. When consultations and visits were included for an analysis of professional RT services during 2014-2016, only 18 percent of episodes involved billing by a single entity (TIN or CCN) as opposed to 94 percent of episodes when consultations and visits were excluded. When consultations and visits were included for an analysis of technical RT services during 2014-2016, 78 percent of episodes involved billing by a single entity (TIN or CCN) as opposed to 94 percent of episodes when consultations and visits were excluded. The difference in percentages is due to the fact that patients see a wide variety of doctors during the course of cancer treatment, which will often involve visits and consultations.

We are not proposing to include E&M services as part of the episode payment. RO participants would continue to bill E&M services under Medicare FFS.

We would also exclude low volume RT services from the RO Model. These include certain brachytherapy surgical procedures, neutron beam therapy, hyperthermia treatment, and radiopharmaceuticals. We are excluding these services from the Model because they are not offered in sufficient amounts for purposes of evaluation.

Given that physicians sometimes contract with others to supply and administer brachytherapy radioactive sources (or radioisotopes), we considered omitting these services from the episode payment. After considering either including or excluding brachytherapy radioelements from the RO Model, we are proposing to include brachytherapy radioactive elements, rather than omit these services, from the episodes because they are generally furnished in HOPDs and the hospitals are usually the purchasers of the brachytherapy radioactive elements. When not furnished in HOPDs, these services are furnished in ASCs, which we are proposing to exclude from the Model. We invite public comments on our proposal, including comments on the proposed inclusion of brachytherapy radioactive sources in the episodes.

The RO Model payments would replace current FFS payments only for the included RT services furnished during an episode. For the included modalities, proposed in section III.C.5.d of this proposed rule, the RO Model episode would include HCPCS codes related to radiation oncology treatment. Please see section III.C.7 for our proposed billing guidelines. We have compiled a list of HCPCS codes that represent treatment pl

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